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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________________________________________________________________

FORM 10-K

~~☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15~~ (D)Mark ~~OF THE SECURITIES EXCHANGE ACT OF 1934~~One)

~~FOR~~☒ ~~THE~~ANNUAL ~~FISCAL~~REPORT ~~YEAR~~PURSUANT ~~ENDED~~TO ~~DECEMBER~~SECTION ~~31,~~13 ~~2020~~OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2021


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For transition period from ______ to ______

Commission file number 1 001-32302

ANTARES PHARMA, INC.

(Exact name of registrant as specified in its charter)

A Delaware ~~Corporation (State or Other Jurisdiction of Incorporation) 41-1350192 (I.R.S. Employer Identification No.)~~

100 Princeton South, Suite 300, Ewing, NJ		08628
(Address of Principal Executive Offices)		(Zip Code)

(State or other jurisdiction of incorporation)

41-1350192

(I.R.S. Employer Identification No.)

100 Princeton South, Suite 300, Ewing, NJ

(Address of principal executive offices)

08628

(Zip Code)

Registrant’s telephone number, including area code: (609) 359-3020

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

~~Trading Symbol(s)~~

~~Name of each exchange on which registered~~

TradingSymbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

~~ATRS~~

~~NASDAQ~~

ATRS

NASDAQ

Securities registered pursuant to section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ ¨ No x ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ ¨ No ☒x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ x No ☐¨

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ x No ☐¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐¨ Accelerated filer ☒x Non-accelerated filer ☐¨ Smaller reporting company ☐¨ Emerging growth company ☐¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ ¨

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☒ No ☐¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒x

~~Aggregate~~The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of June 30, ~~2020~~2021, was $~~447~~739.8 4 million ( based ~~upon~~on the ~~last~~closing ~~reported sale~~ price of $24.7536 per share on June 30, ~~2020,~~2021 onas reported by the NASDAQ Capital Market).

~~There~~As of February 28, 2022, there were ~~168~~170,~~161~~106,~~177~~346 shares of common stock outstanding ~~as of February 26, 2021~~.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the definitive ~~proxy~~Proxy ~~statement~~Statement ~~for the registrant’s 2021 annual meeting of stockholders~~ to be filed within 120 days after the end of the period covered by this ~~annual~~ report onfor ~~Form~~the ~~10-K~~registrant’s 2022 Annual Meeting of Stockholders are incorporated by reference into Part III of this ~~annual~~Annual ~~report~~Report on Form 10-K.

ANTARES PHARMA, INC.

~~FORM~~Annual Report on Form 10-K

For the Year Ended December 31, 2021

TABLE OF CONTENTS

PART I
Note Regarding Forward-Looking Statements				3
Item 1	Business		4
		PART I
Item 1A	Risk Factors		31
Item 1.		Business		6
Item 1B	Unresolved Staff Comments		45
Item 1A.		Risk Factors		39
Item 2	Properties		45
Item 1B.		Unresolved Staff Comments		53
Item 3	Legal Proceedings		45
Item 2.		Properties		53
Item 4	Mine Safety Disclosures		45
Item 3.		Legal Proceedings		54
PART II
Item 4.		Mine Safety Disclosures		54
Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities		46
		PART II
Item 6	Selected Financial Data		47
Item 5.		Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities		55
Item 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations		48
Item 6.		[Reserved]		56
Item 7A	Quantitative and Qualitative Disclosures About Market Risk		56
Item 7.		Management’s Discussion and Analysis of Financial Condition and Results of Operations		56
Item 8	Financial Statements and Supplementary Data		57
Item 7A.		Quantitative and Qualitative Disclosures About Market Risk		65
Item 9	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		86
Item 8.		Financial Statements and Supplementary Data		66
Item 9A	Controls and Procedures		86
Item 9.		Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		99
Item 9B	Other Information		86
Item 9A.		Controls and Procedures		99
PART III
Item 9B.		Other Information		99
Item 10	Directors, Executive Officers and Corporate Governance		87
		PART III
Item 11	Executive Compensation		87
Item 10.		Directors, Executive Officers and Corporate Governance		100
Item 12	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		87
Item 11.		Executive Compensation		100
Item 13	Certain Relationships and Related Transactions, and Director Independence		87
Item 12.		Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		100
Item 14	Principal Accounting Fees and Services		87
Item 13.		Certain Relationships and Related Transactions, and Director Independence		101
PART IV
Item 14.		Principal Accounting Fees and Services		101
Item 15	Exhibits and Financial Statement Schedules		88
		PART IV
	Signatures		91
Item 15.		Exhibits and Financial Statement Schedules		102
Item 16.		Form 10-K Summary		104
		Signatures		105

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Note Regarding Forward-Looking Statements

This annual report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. ~~You~~Undue reliance should not ~~place~~be ~~undue~~placed ~~reliance~~ on those statements because they are subject to numerous uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. ~~You~~These statements can ~~identify~~be ~~these~~identified ~~statements~~ by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” ~~and~~“may,” “continue,” or other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property, our commercial operations and product development. In particular, these forward-looking statements include, among others, statements about:

• our expectations about the ongoing COVID-19 pandemic (the “Pandemic”) and any potential disruption or impact to our operations, financial position or cash flows;

• our expectations regarding the continued ~~successful~~ commercialization of XYOSTED® (testosterone enanthate) injection and the continued growth in prescriptions and revenues related thereto;

• our expectations regarding ~~continued~~the ~~sales~~commercialization of ~~OTREXUP~~NOCDURNA® (~~methotrexate~~desmopressin acetate) ~~injection~~in the U.S. under a licensing agreement with Ferring International Center S.A. and its affiliates, (“Ferring”) and future sales and revenue from the same;

• our expectations regarding ~~the~~future ~~recent~~FDA ~~licensing~~approval ~~agreement~~of ~~with~~TLANDO® ~~Ferring~~in ~~International~~the ~~Center~~ U.S.A. ~~and~~under ~~its~~a ~~affiliates,~~licensing agreement with Lipocine Inc. (“~~Ferring~~Lipocine”), ~~for~~ the ~~U.S.~~manufacturing ~~marketed~~and ~~product~~commercialization ~~NOCDURNA~~of TLANDO® ~~(desmopressin acetate)~~ and future sales and revenue ~~therefrom~~from the same;

• our expectations regarding ~~the~~whether ~~ability~~we ofwill ~~our~~exercise ~~partner,~~the ~~Teva,~~option tofor ~~continue~~LPCN to1111 ~~successfully~~(“TLANDO ~~commercialize~~XR”) ~~Epinephrine~~and, ~~Injection~~if ~~USP~~exercised, the ~~generic~~future ~~equivalent~~timing ~~version~~and success of ~~EpiPen®~~the ~~(“generic~~clinical ~~epinephrine~~development ~~injection”),~~program ~~and~~for ~~any~~TLANDO XR and future FDA approval, market acceptance and revenue ~~related~~from ~~thereto~~the same;

• our expectations regarding ~~the~~future ~~ability~~sales of ~~AMAG Pharmaceuticals, Inc.~~ OTREXUP® (~~“AMAG”~~methotrexate) toinjection ~~continue~~ to ~~commercialize~~Otter ~~Makena® (hydroxyprogesterone caproate injection)~~Pharmaceuticals, ~~and~~LLC ~~our~~(a ~~continued~~wholly-owned ~~future~~subsidiary ~~sales~~of toAssertio ~~AMAG~~Holdings, ~~and~~Inc., ~~royalty~~together ~~revenue~~with ~~from~~Assertio ~~the~~Holdings, ~~same~~Inc., inas ~~light~~guarantor, ofindividually ~~the~~and ~~U.S.~~collectively ~~Food~~referred ~~and~~to ~~Drug~~as ~~Administration’s (~~“~~FDA~~Otter”) ~~recent~~under ~~proposal~~a tonewly ~~withdraw~~entered ~~approval~~into ofsupply ~~Makena® (hydroxyprogesterone caproate injection)~~agreement, ~~AMAG’s~~as ~~request~~well ~~for~~as athe ~~hearing~~ability ~~to maintain its approval~~ of ~~Makena®~~Otter ~~(hydroxyprogesterone~~to ~~caproate~~pay ~~injection),~~remaining ~~and~~installment ~~the~~payments ~~timing and outcome~~ of ~~any hearings and future regulatory actions by~~ the ~~FDA~~purchase price;

• our expectations regarding ~~continued~~the ~~sales~~ability of ~~Sumatriptan Injection USP to~~ our partner, Teva Pharmaceutical Industries, Ltd. (“Teva”), ~~and~~to ~~Teva’s~~continue ~~ability~~ to ~~successfully~~commercialize ~~distribute~~Epinephrine Injection USP, the generic equivalent version of EpiPen® (“generic epinephrine injection”), and ~~sell~~any ~~Sumatriptan~~future ~~Injection~~revenue ~~USP~~related thereto;

• our expectations regarding ~~continued~~the ~~product~~ability ~~development~~of ~~with~~the ~~Teva~~Covis ofGroup ~~the~~S.a.r.l. ~~teriparatide~~(“CG”), who acquired AMAG Pharmaceuticals, Inc. (“AMAG”) (collectively CG and ~~exenatide~~AMAG ~~disposable~~are ~~pen~~herein ~~injectors~~after referred to as “Covis”) in November 2020, ~~Teva’s~~to ~~ability~~continue to ~~obtain~~commercialize ~~FDA~~Makena® ~~approval~~(hydroxyprogesterone caproate injection) and ~~AB-rating~~our ~~for~~continued ~~each~~future ofsales ~~those~~to ~~products~~Covis and royalty revenue from the same, in light of the U.S. Food and ~~Teva~~Drug Administration’s ~~ability~~(“FDA”) proposal to ~~successfully~~withdraw ~~commercialize~~approval of Makena® (hydroxyprogesterone caproate injection) and the ~~teriparatide~~timing ~~disposable~~and ~~pen~~outcome ~~injector~~of ~~product~~any ~~outside~~hearings and future regulatory actions by the ~~U.S.~~FDA;

• our expectations ~~about~~regarding ~~the~~continued ~~development~~sales of aSumatriptan ~~rescue~~Injection ~~pen~~USP ~~for~~to ~~an undisclosed drug with~~ our partner, ~~Pfizer~~Teva, ~~Inc. (“Pfizer”)~~ and ~~potential~~Teva’s ~~future~~ability ~~regulatory~~to ~~approval~~distribute and ~~future~~sell ~~revenue~~Sumatriptan ~~from~~Injection ~~the same~~USP;

• our expectations ~~about~~regarding ~~our~~continued product development ~~activities~~ with ~~Idorsia~~Teva ~~Pharmaceuticals Ltd (“Idorsia”), including the timing and results~~ of the ~~clinical~~teriparatide ~~bridging~~disposable ~~and~~pen ~~Phase~~injector, 3Teva’s ~~clinical~~ability ~~trial~~to ofobtain ~~the~~FDA ~~drug~~approval ~~device~~and ~~combination~~AB-rating ~~product~~ for ~~selatogrel, a new chemical entity (“NCE”) being developed for~~ the ~~treatment~~products ofand aif ~~suspected~~approved ~~acute~~Teva’s ~~myocardial~~ability ~~infarction~~to ~~(“AMI”)~~successfully incommercialize ~~adult patients with a history of AMI, and~~ the ~~potential~~teriparatide ~~future~~disposable ~~FDA~~pen ~~and~~injector ~~global~~product ~~regulatory~~outside ~~approval of~~ the ~~same~~U.S.;

• our expectations about ~~our~~the ~~research and~~ development ~~projects,~~of ~~including~~a ~~but~~rescue ~~not~~pen ~~limited~~for toan ~~ATRS-1901~~undisclosed ~~and~~drug ~~ATRS-1902,~~with ~~the~~our ~~timing~~partner ~~and~~Pfizer ~~results~~Inc. of(“Pfizer”) ~~clinical trials,~~ and ~~our~~potential ~~anticipated~~future ~~continued~~regulatory ~~reliance~~approval ~~on third parties in conducting studies, trials~~ and ~~other~~future ~~research~~revenue ~~and~~from ~~development~~the ~~activities~~same;

• our expectations about our development activities with Idorsia Pharmaceuticals Ltd (“Idorsia”) and the timing and ~~outcome~~results of ~~pending~~the orPhase ~~potential~~3 ~~claims~~clinical ~~and~~trial ~~litigation,~~of ~~including~~the ~~without~~drug ~~limitation~~device combination product for selatogrel, a new chemical entity being developed for the ~~pending~~treatment ~~securities~~of ~~class~~a ~~action~~suspected acute myocardial infarction (“AMI”) in adult patients with a history of AMI, and ~~derivative~~the ~~actions~~potential future FDA and global regulatory approval of the same;

• our ~~anticipated~~expectations ~~continued~~about ~~reliance~~the ondevelopment ~~contract~~of ~~manufacturers~~ATRS-1902 tofor ~~manufacture~~adrenal crisis rescue, ~~assemble~~including the timing and ~~package~~results of clinical trials and our ~~products~~anticipated 505(b)(2) NDA filing with the FDA;

• our anticipated continued reliance on third parties to provide certain services for our products including logistics, warehousing, distribution, invoicing, contract administration and chargeback processing;

• our sales and marketing plans;

• expectation about our future revenues, including the 2021 revenue guidance, our cash flows and our ability to support our operations and maintain profitability;

• our estimates and expectations regarding the sufficiency of our cash resources, anticipated capital requirements and our ability to obtain additional financing, if needed;

• our expectations and estimates made in connection with current accounting practices, including but not limited to, the carrying value of our deferred tax assets and our ability to utilize net operating loss and other credit carryforwards to offset future U.S. federal taxable income;

• the potential impact of new accounting pronouncements and tax legislation; and

• other statements regarding matters that are not historical facts or statements of current condition.

These forward-looking statements are based on assumptions that we have made in light of our industry experience as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this annual report, you should understand that these statements are not guarantees of performance results. Forward-looking statements involve known and unknown risks, uncertainties and assumptions, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. While we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and projections of the future about which we cannot be certain. Many factors may affect our ability to achieve our objectives, including:

• potential business interruptions and/or any financial or operational impact as a result of the COVID-19 Pandemic;

• delays in product introduction or unsuccessful marketing and commercialization efforts by us or our partners;

• interruptions in supply or an inability to adequately manage third party contract manufacturers to meet customer supply requirements;

• our inability to obtain or maintain adequate third-party payer coverage of marketed products;

• the timing and results of our or our partners’ research projects or clinical trials of product candidates in development including projects with Teva, Pfizer and Idorsia;

• actions by the FDA or other regulatory agencies with respect to our products or product candidates of our partners;

• our inability to generate or sustain continued growth in product sales and royalties;

• the lack of market acceptance of our and our partners’ products and future revenues from these products;

• a decrease in business from our major customers and partners;

• our inability to compete successfully against new and existing competitors or to leverage our research and development capabilities or our marketing capabilities;

• our inability to establish and maintain our sales and marketing capability, our inability to effectively market our services or obtain and maintain arrangements with our customers, partners and manufacturers;

• changes or delays in the regulatory review and approval process;

• our inability to effectively protect our intellectual property;

• costs associated with future litigation and the outcome of such litigation;

• our inability to attract and retain key personnel; and

• adverse economic and political conditions.

Forward-looking statements made by us in this annual report speak only as of the date of this annual report. Actual results could differ materially from those currently anticipated as a result of a number of risk factors, including, but not limited to, the risks and uncertainties discussed under the caption “Risk Factors.” New risks and uncertainties come up from time to time, and it is impossible for us to predict these events or how they may affect us. We do not undertake to update or revise the forward-looking statements in this annual report after the date of this annual report, except as required by law. In light of these risks and significant uncertainties, you should not regard the forward-looking statements in this annual report as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, if at all.

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•our expectations about our other internal and external research and development projects, including but not limited to ATRS-1901 and ATRS-1903, the timing and results of clinical trials, and our anticipated continued reliance on third parties in conducting studies, trials and other research and development activities;

•our expectations about the timing and outcome of pending or potential claims and litigation, including without limitation, the pending securities class action and derivative actions;

•our anticipated continued reliance on contract manufacturers to manufacture, assemble and package our products;

•our anticipated continued reliance on third parties to provide certain services for our products including logistics, warehousing, distribution, invoicing, contract administration and chargeback processing;

•our sales and marketing plans;

•our expectation about our future revenues, our cash flows and our ability to support our operations and maintain profitability;

•our estimates and expectations regarding the sufficiency of our cash resources, anticipated capital requirements and our ability to obtain additional financing, if needed;

•the potential impact of new accounting pronouncements and tax legislation; and

•other statements regarding matters that are not historical facts or statements of current condition.

These forward-looking statements are based on assumptions that we have made considering our industry experience as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this annual report, you should understand that these statements are not guarantees of performance results. Forward-looking statements involve known and unknown risks, uncertainties and assumptions, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. While we believe that we have a reasonable basis for each forward-looking statement contained in this annual report, we caution you that these statements are based on a combination of facts and factors currently known by us and projections of the future about which we cannot be certain. Many factors may affect our ability to achieve our objectives, including:

•potential business interruptions and/or any financial or operational impact as a result of the Pandemic;

•delays in product introduction or unsuccessful marketing and commercialization efforts by us or our partners;

•interruptions in supply or an inability to adequately manage third party contract manufacturers to meet customer supply requirements;

•our inability to obtain or maintain adequate third-party payer coverage of marketed products;

•the timing and results of our or our partners’ research projects or clinical trials of product candidates in development;

•actions by the FDA or other regulatory agencies with respect to our products or product candidates of our partners;

•our inability to generate or sustain continued growth in product sales and royalties;

•the lack of market acceptance of our and our partners’ products and future revenues from these products;

•a decrease in business from our major customers and partners;

•our inability to compete successfully against new and existing competitors or to leverage our research and development capabilities or our marketing capabilities;

•our inability to establish and maintain our commercial capabilities, our inability to effectively market our services or obtain and maintain arrangements with our customers, partners and manufacturers;

•our inability to attract and retain key personnel;

•changes or delays in the regulatory review and approval process;

•our inability to effectively protect our intellectual property;

•costs associated with future litigation and the outcome of such litigation; and

•adverse economic and political conditions.

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The performance of our business and our securities may be adversely affected by these factors and by other factors common to other businesses or to the general economy. Forward-looking statements speak only as of the date on which such statements are made. Actual results could differ materially from those currently anticipated as a result of a number of risk factors, including, but not limited to, the risks and uncertainties discussed in Item 1A of Part II of this Annual Report on Form 10-K. New risks and uncertainties emerge from time to time, and it is impossible for us to predict these events or how they may affect us. Forward-looking statements are qualified by some or all of these risk factors. Therefore, you should consider these forward-looking statements with caution and form your own critical and independent conclusions about the likely effect of these risk factors on our future performance. We undertake no obligation to update or revise any forward-looking statements included in this annual report to reflect events or circumstances after the date on which such statement is made, except as required by law. In light of these risks and significant uncertainties, you should not regard the forward-looking statements in this annual report as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, if at all. You should carefully review the disclosures and the risk factors described in this Annual Report on Form 10-K and in other documents we file from time to time with the Securities and Exchange Commission (“SEC”), including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.

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PART I

~~Item~~ITEM 1. BUSINESS

Company Overview

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address ~~unmet~~patient needs in targeted therapeutic areas. We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, ~~reduced~~convenience, ~~side~~improved ~~effects~~tolerability, ~~convenience,~~ and enhanced patient comfort and adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed ~~significant strategic alliances and~~ partnership arrangements with several different industry leading pharmaceutical companies ~~including Pfizer, Idorsia, Teva and AMAG~~. Our FDA-approved products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection, NOCDURNA® (desmopressin acetate), which is licensed from Ferring Pharmaceuticals, and Sumatriptan Injection USP, which is distributed by Teva. We are also the exclusive supplier of devices to Teva for their Epinephrine Injection USP, the generic equivalent of EpiPen® and EpiPen® Jr., the devices for Teva’s generic teriparatide injection product, and of the Makena® subcutaneous auto injectors to AMAG.

~~2020~~Our ~~Highlights~~FDA-approved products include XYOSTED® (testosterone enanthate) injection; OTREXUP® (methotrexate) injection, which was sold to Otter in December 2021; NOCDURNA® (desmopressin acetate), which is licensed from Ferring; and ~~Areas~~Sumatriptan Injection USP, which is distributed by Teva. We are also the exclusive supplier of ~~Focus~~devices to Teva for their Epinephrine Injection USP, the generic equivalent of EpiPen® and EpiPen® Jr.; the devices for Teva’s generic teriparatide; OTREXUP® (methotrexate) injection to Otter beginning in December 2021; and of the Makena® subcutaneous auto injectors to Covis.

We2021 ~~achieved~~Highlights ~~several significant operating~~ and ~~financial~~Areas ~~milestones~~of ~~in 2020:~~Focus

~~• Record Revenue and Financial Results –~~ We ~~generated~~achieved ~~record~~several ~~revenue~~significant of $149.6 million for the year ended December 31, 2020 as compared to $123.9 million for the year ended December 31, 2019, representing growth of 21% on a year over year basis. We also reported full year net income, earnings per share and positive operating ~~cashflow in 2020. We generated record pre-tax income of $9.9 million~~ and ~~recognized~~financial anmilestones ~~income tax benefit of $46.3 million, resulting~~ in net income and basic earnings per share of $56.2 million and $0.34, respectively, for the year ended December 31, 2020 as compared to a net loss and net loss per share of $2.0 million and $0.01, respectively, for the year ended December 31, 2019. Earnings per share on a fully diluted basis was $0.33 for the year ended December 31, 2020.2021:

•Record ~~Significant~~Revenue ~~Growth~~and ofFinancial ~~XYOSTED®~~Results – We ~~Our~~generated ~~proprietary~~record ~~product~~revenue ~~XYOSTED®~~of ~~(testosterone~~$184.0 ~~enanthate)~~million ~~injection, indicated~~ for ~~testosterone~~the ~~replacement~~year ~~therapy~~ended inDecember 31, ~~adult~~2021 ~~males~~as ~~for~~compared ~~conditions~~to ~~associated~~$149.6 ~~with~~million afor ~~deficiency~~the oryear ~~absence~~ended ofDecember 31, ~~endogenous testosterone~~2020, ~~continued~~representing toyear-over-year ~~grow~~growth ~~significantly~~of in23.0%. ~~2020,~~We ~~generating~~generated ~~annual~~record ~~net~~pre-tax ~~revenue~~income of $4662.53 million ~~for~~resulting ~~the~~in ~~year~~net ~~ended~~income ~~December~~and ~~31,~~basic ~~2020~~earnings ~~compared~~per toshare of $2046.83 million and $0.27, respectively, for the year ended December 31, ~~2019.~~2021 Weas ~~attribute~~compared ~~this 124% increase~~ to ~~successful~~net ~~marketing~~income ~~strategies, achieving~~ and ~~maintaining~~basic ~~targeted~~earnings ~~reimbursement~~per ~~coverage,~~share ~~and~~of ~~our~~$56.2 ~~ability~~million toand ~~leverage~~$0.34, ~~our~~respectively, ~~virtual~~for ~~capabilities to support~~ the ~~continued~~year ~~growth~~ended inDecember 31, ~~year~~2020. ~~two~~Earnings ofper ~~product~~share ~~launch~~on ~~despite~~a ~~the~~fully ~~challenges~~diluted ~~presented~~basis bywas ~~the Pandemic~~$0.26 ~~XYOSTED®~~for is the ~~only~~year ~~FDA~~ended ~~approved~~December ~~subcutaneous~~31, ~~testosterone~~2021 ~~enanthate~~compared ~~product~~to $0.33 for ~~once-weekly,~~the ~~at-home~~year ~~self-administration~~ended ofDecember ~~testosterone~~31, ~~replacement therapy~~2020.

•Significant ~~Expanded~~Growth ~~Product~~of ~~Portfolio~~XYOSTED® – ~~with~~Our ~~In-License~~proprietary ofproduct ~~NOCDURNA~~XYOSTED® (testosterone –enanthate) Weinjection, ~~entered~~indicated ~~into~~for antestosterone ~~exclusive~~replacement ~~license~~therapy ~~agreement~~in ~~with~~adult ~~Ferring~~males ~~Pharmaceuticals~~ for ~~NOCDURNA®~~conditions ~~(desmopressin~~associated ~~acetate)~~with ~~marketed~~a indeficiency ~~the~~or ~~U.S.~~absence ~~and~~of ~~indicated~~endogenous ~~for~~testosterone, ~~the~~continued ~~treatment~~to ofgrow ~~nocturia~~significantly ~~due~~in to2021, ~~nocturnal~~generating ~~polyuria~~annual ~~(NP)~~net inrevenue ~~adults~~of ~~who~~$62.2 ~~awaken~~million atfor ~~least~~the ~~two~~year ~~times~~ended ~~per~~December ~~night~~31, 2021 compared to ~~urinate~~$46.5 ~~NOCDURNA®~~million ~~expands~~for ~~and~~the ~~complements~~year ~~our~~ended ~~existing~~December ~~portfolio~~31, of2020. ~~proprietary~~We ~~products~~attribute ~~and~~this ~~allows~~33.7% usincrease to ~~leverage~~successful ~~our~~marketing ~~existing~~strategies, ~~commercial~~achieving ~~organization~~and inmaintaining targeted ~~therapeutic~~reimbursement ~~areas.~~coverage, Weand ~~began~~our ~~detailing~~ability ~~NOCDURNA®~~to incontinue ~~the~~to ~~fourth~~leverage ~~quarter~~our ofvirtual ~~2020~~capabilities ~~and~~to ~~are~~support ~~currently~~the growth in 2021 despite the ~~process~~challenges ofpresented ~~re-launching~~by the ~~product~~Pandemic. ~~with~~XYOSTED® is athe ~~comprehensive~~only ~~strategy~~FDA toapproved ~~increase~~subcutaneous ~~awareness~~testosterone ~~and~~enanthate ~~demand~~product for once-weekly, at-home self-administration of testosterone replacement therapy.

•Expanded ~~Navigating~~Product ~~the~~Portfolio ~~Global~~with ~~Pandemic~~In-License of TLANDO® – We ~~have~~entered ~~taken~~into ~~several~~an ~~measures~~exclusive tolicense ~~actively~~agreement ~~manage~~with ~~and~~Lipocine ~~help~~for ~~minimize~~ the ~~impact~~product ofTLANDO® ~~the~~(testosterone ~~COVID-19~~undecanoate) ~~pandemic~~in onthe ~~our business~~U.S., Wea ~~have~~twice-daily ~~implemented~~oral ~~safety~~formulation ~~measures~~of ~~and~~testosterone ~~protocols~~for totestosterone ~~protect~~replacement ~~the~~therapy ~~health~~indicated ~~and~~for ~~safety~~conditions ofassociated ~~our employees and comply~~ with ~~governmental~~a ~~and~~deficiency ~~public~~or ~~health~~absence ~~guidelines~~of ~~while~~endogenous ~~working~~testosterone, toor ~~ensure~~hypogonadism ~~the~~in ~~sustainability~~adult ofmales. ~~our~~TLANDO® ~~business~~was ~~operations~~granted ~~and~~tentative ~~continuity~~approval offrom ~~supply.~~the WeFDA ~~shifted~~in toDecember a2020 ~~primarily~~and ~~remote~~will ~~work~~be ~~environment~~eligible for ~~our~~final ~~corporate~~FDA approval and ~~administrative~~marketing ~~functions~~in ~~and~~the ~~limited~~U.S. ~~the~~upon ~~number~~expiration of ~~staff~~the inexclusivity ~~our~~period ~~facilities~~previously granted to ~~those~~Clarus ~~necessary for essential functions such as research~~Therapeutics, ~~development, manufacturing and supply~~Inc. ~~Our~~(“Clarus”) ~~sales~~for ~~force~~JATENZO® ~~has been subject to varying limitations~~ on ~~their~~March ~~ability~~27, to2022. ~~physically~~On ~~visit~~February ~~physicians~~3, ~~and~~2022, ~~in response~~ we ~~strategically~~announced ~~shifted~~the toFDA’s aacceptance ~~virtual~~of ~~detailing platform and continued to utilize~~ our ~~social~~NDA ~~media~~resubmission ~~presence~~for toTLANDO® ~~connect~~ with ~~our~~a ~~existing~~target ~~and~~action ~~potential~~date ~~customers~~set ~~and~~for ~~healthcare~~March ~~professionals. While our field-based team has now resumed in-person interaction with fewer restrictions~~28, we2022. ~~believe~~We wecontinue ~~are~~to ~~also~~prepare ~~well-positioned~~for ~~with~~the ~~our~~launch ~~virtual~~of ~~capabilities~~TLANDO® toin ~~continue~~2022 topending ~~engage~~final ~~healthcare~~FDA ~~professionals~~approval ~~and~~after ~~patients through~~ the ~~ongoing~~expiration ~~Pandemic~~of ~~and~~JATENZO®’s ~~beyond~~exclusivity period.

In•Aligned ~~addition~~Proprietary toPortfolio ~~these~~with ~~significant~~Divestiture ~~achievements~~of OTREXUP® – We divested and ~~areas~~sold our proprietary product line OTREXUP® (methotrexate) injection for the treatment of ~~focus~~rheumatoid arthritis to Otter in ~~2020,~~December we2021 ~~continued~~for a total purchase price of $44.0 million (the “Asset Purchase Agreement”), subject to ~~devote~~finalization ~~resources~~of ~~and~~changes ~~advance~~in ~~our~~closing ~~internal~~inventory ~~research~~to ~~and~~be ~~development~~transferred. ~~programs~~This divestiture allows us to further ~~expand~~align our ~~product~~commercial ~~pipeline.~~detailing Westrategy ~~also~~to ~~made~~focus ~~significant~~on ~~progress~~the onurology ~~partnered~~and ~~development~~endocrinology ~~projects~~fields ~~with~~to enhance our ~~partners~~growth ~~Pfizer~~strategy ~~and~~for ~~Idorsia~~XYOSTED®, ~~made~~NOCDURNA® ~~investments~~and inthe ~~capital~~anticipated ~~improvements~~launch ~~and~~of ~~infrastructure,~~TLANDO® ~~and~~in ~~maintained~~2022. aWith ~~disciplined~~the ~~approach~~asset sale, we will continue to ~~growth~~manufacture and ~~operating~~supply ~~expenditures~~OTREXUP® to ~~support~~Otter ~~our~~as ~~continued~~a ~~and~~partnered ~~future growth~~product.

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•Significant Progress on Our Adrenal Crisis Rescue Pen (ATRS-1902) – We further advanced our ATRS-1902 development program with positive results from a Phase 1 clinical study for adrenal crisis and were granted Fast Track designation by the FDA. The results support the advancement of our ATRS-1902 development program to a pivotal clinical study for the treatment of acute adrenal insufficiency (“adrenal crisis”) in adults and adolescents, using our Vai™ novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone. We anticipate starting this pivotal clinical study in the second quarter of 2022 and expect to submit a 505(b)(2) NDA with the FDA by the end of 2022 pending the success of the pivotal clinical study.

•Continued Navigation of the Global Pandemic – We have taken several measures to manage and minimize the impact of the Pandemic on our business. We have implemented safety measures and protocols to protect the health and safety of our employees and comply with governmental and public health guidelines while ensuring the sustainability of our business operations and continuity of product supply. We continue to monitor the situation, including the COVID-19 variants, and potential effects on our business, suppliers, partners and workforce. We have implemented a hybrid work environment with the ability to shift remote as necessary to limit the number of individuals in our facilities to those necessary for essential functions such as research, development, manufacturing and supply. While our field-based team has resumed in-person interaction with fewer restrictions, we believe we are also well-positioned with our virtual capabilities to continue to engage healthcare professionals and patients through the Pandemic and beyond.

In addition to these significant achievements and areas of focus in 2021, we continued to devote resources and advance our internal research and development programs to further expand our product pipeline. We also made significant progress on partnered development projects, made investments in capital improvements and infrastructure, and maintained a disciplined approach to growth and operating expenditures to support our continued and future growth.

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Product Portfolio Overview

The following table provides an overview of our proprietary and partnered commercial products and product opportunities:

Approved Products

~~Drug~~

Drug

~~Partner~~

~~Indication~~Partner

~~Territory~~

Disease/Condition

Territory

XYOSTED® (testosterone enanthate) injection

~~Testosterone~~

Testosterone

~~None~~

~~Testosterone Replacement Therapy (“TRT”)~~None

~~U.S.~~

Testosterone Replacement Therapy (“TRT”)

U.S.

OTREXUP® (methotrexate) injection

Methotrexate

None

Rheumatoid Arthritis; pJIA, Psoriasis

U.S.

OTREXUP® (methotrexate) injection 1

Methotrexate

None 1

Rheumatoid Arthritis; pJIA, Psoriasis

U.S.

NOCDURNA® (desmopressin acetate)

~~Desmopressin~~

Desmopressin

None*

~~Nocturnal~~None ~~Polyuria~~2

~~U.S.~~

Nocturnal Polyuria

U.S.

Epinephrine Injection USP (generic equivalent to EpiPen® and EpiPen® Jr.)

~~Epinephrine~~

Epinephrine

~~Teva~~

~~Anaphylaxis~~Teva

~~U.S.~~

Anaphylaxis

U.S.

Sumatriptan Injection USP (generic equivalent to Imitrex® STATdose Pen®)

Sumatriptan succinate

Teva

Migraines

U.S.

Sumatriptan Injection USP (generic version of Imitrex® STATdose Pen®)

Sumatriptan succinate

Teva

Migraines

U.S.

Makena® Subcutaneous Auto Injector

~~Hydroxy-progesterone caproate~~

Hydroxy-progesterone caproate

~~AMAG~~

~~Reduced Risk of Pre-term Birth~~Covis

~~U.S.~~

Reduced Risk of Pre-term Birth

U.S.

Teriparatide Injection (generic version of Forsteo®)

~~Teriparatide~~

Teriparatide

~~Teva~~

~~Osteoporosis~~Teva

~~Outside U.S.~~

Osteoporosis

Outside U.S.

Products in Development

Drug

Partner

Indication

Territory

Disposable Pen Injector

Exenatide

Teva

Diabetes

U.S.

Disposable Pen Injector

Teriparatide

Teva

Osteoporosis

U.S.

QuickShot® Auto Injector

Undisclosed

Pfizer

Undisclosed Rescue Pen

U.S.

QuickShot® Auto Injector

Selatogrel

Idorsia

Acute Myocardial Infarction

Worldwide

Drug/Device Product

ATRS-1901

None

Urologic Oncology

U.S.

Drug/Device Product

ATRS-1902

None

Endocrinology

U.S.

*Distributed and sold by us under an exclusive license agreement with Ferring.

Select Products in Development

Drug

Partner

Indication

Territory

TLANDO® (testosterone undecanoate) 3

Testosterone

None 3

Testosterone Replacement Therapy (“TRT”)

U.S.

Disposable Pen Injector 4

Exenatide

Teva

Diabetes

U.S.

Disposable Pen Injector

Teriparatide

Teva

Osteoporosis

U.S.

QuickShot® Auto Injector

Undisclosed

Pfizer

Undisclosed Rescue Pen

U.S.

QuickShot® Auto Injector

Selatogrel

Idorsia

Acute Myocardial Infarction

Worldwide

Drug/Device Product

ATRS-1901

None

Urologic Oncology

U.S.

Drug/Device Product

ATRS-1902

None

Endocrinology

U.S.

Drug/Device Product

ATRS-1903

None

Immunology

U.S.

~~For~~1 Certain aworldwide ~~detailed~~assets ~~discussion~~used ofin ~~our~~the ~~proprietary~~operation ~~and~~of ~~partnered~~the ~~approved~~OTREXUP® ~~and~~product ~~marketed~~were ~~products,~~sold ~~and~~to ~~other~~Otter ~~products~~in ~~currently~~December in2021. ~~development,~~We ~~see~~will ~~“Our~~continue ~~Products”~~to manufacture and ~~“Research~~supply ~~and~~OTREXUP® ~~Development”~~to ~~sections~~Otter ~~below~~as a partnered product under a separate supply agreement.

2 Distributed and sold by us under an exclusive license agreement with Ferring.

3 TLANDO® was granted tentative approval from the FDA in December 2020 and will be eligible for final FDA approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus for JATENZO® on March 27, 2022. TLANDO® is expected to be distributed and sold by us under an exclusive license agreement with Lipocine pending final approval from the FDA. We announced the FDA’s acceptance of our application for final approval on February 3, 2022 with a target action date set for March 28, 2022.

4 On February 25, 2022, Teva notified us that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022.

For a detailed discussion of our proprietary and partnered approved and marketed products, and other products currently in development, see “Our Products” and “Research and Development” sections below included in Item 1 of Part I of this Annual Report on Form 10-K.

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Corporate Information

Antares iswas aincorporated under Delaware ~~corporation~~law in 2005 with principal executive offices located atin ~~100 Princeton South Corporate Center, Suite 300,~~ Ewing, New Jersey ~~08628~~. We have two wholly owned subsidiaries in Switzerland (Antares Pharma AG and Antares Pharma IPL AG)~~. On~~ ~~January~~and ~~31,~~operate ~~2001,~~under ~~we completed~~ a ~~business~~single ~~combination~~reportable tooperating ~~acquire~~segment, ~~the~~which ~~operating~~encompasses ~~subsidiaries~~all of ~~Permatec~~our ~~Holding~~pharmaceutical ~~AG,~~products ~~headquartered~~and ~~in Basel, Switzerland~~technologies. ~~Upon~~Segment ~~completion~~and ofgeographic ~~the~~financial ~~transaction,~~information ~~our~~are ~~name~~included ~~was~~in ~~changed~~Note ~~from~~2 ~~Medi~~and ~~Ject~~Note ~~Corporation~~14 to ~~Antares~~the ~~Pharma,~~Consolidated ~~Inc.~~Financial WeStatements ~~were~~in ~~incorporated~~Item as8 aof ~~Delaware~~Part ~~corporation~~II onof ~~April~~this ~~29,~~Annual ~~2005~~Report on Form 10-K.

Segment and Geographic Information

We have a single reportable operating segment, which encompasses all of our pharmaceutical products and technologies. See Note 2 and Note 14 to the Consolidated Financial Statements in Part II, Item 8 about segment and geographic financial information.

Our Strategy and Market Opportunity

Our strategy is to grow the business through targeted investments in internal and partnered product development and other corporate opportunities ~~that leverage our patented drug delivery technology platforms~~, as well as leverage our commercial infrastructure, primarily focused in certain therapeutic areas. We have built a robust commercial organization to market and sell our proprietary products and have significant experience in developing drug/device combination products and navigating the regulatory approval process.

5Historically, our focus has been primarily the market for self-administered injectable drugs. We identify development and commercialization opportunities, both internally and through partnered or business development opportunities that apply patented drug delivery technologies to new or existing approved drug formulations. Through these opportunities, we seek to enhance the drug delivery methods and provide commercial and/or functional advantages, such as improved safety and efficacy, reduced side effects, convenience and enhanced patient comfort and adherence. In addition to self-administered injectable drugs, we explore opportunities beyond injectable drugs that may complement our strategy and leverage our capabilities. We pursue these opportunities both on our own or with partners. We believe this strategy offers a distinct value to patients, healthcare providers, pharmaceutical partners and our shareholders.

~~Historically,~~Injection ~~our~~is ~~focus~~a ~~has~~common ~~been~~drug ~~primarily~~delivery onpathway, and the ~~market for~~ delivery of ~~self-administered~~pharmaceutical ~~injectable~~therapies ~~drugs.~~through Weinjection ~~seek~~systems tooften ~~identify~~improves ~~development~~the ~~and~~systemic ~~commercialization~~bioavailability ~~opportunities,~~of ~~both~~those ~~internally~~treatments ~~and~~by ~~through~~overcoming ~~partnered~~absorption orbarriers ~~business~~common ~~development~~with ~~opportunities~~oral and, ~~that~~in ~~apply~~some ~~patented~~cases, ~~drug~~transdermal delivery. ~~technologies~~Improved tobioavailability ~~new~~is orbeneficial ~~existing~~when ~~approved~~evaluating ~~drug~~the ~~formulations~~role inof ~~order~~route toof ~~enhance~~administration ~~the~~on ~~drug~~pharmaceutical ~~delivery~~efficacy. ~~methods~~We ~~and~~believe that our advanced injection technology platforms provide ~~commercial~~drug ~~and/or~~delivery ~~functional~~solutions ~~advantages,~~that ~~such~~can asresult in improved safety and efficacy, reduced side effects, ~~convenience~~ and enhanced patient comfort and adherence. InMany ~~addition~~pharmaceutical tocompanies ~~self-administered~~focus ~~injectable~~on ~~drugs,~~the wedevelopment ~~have~~of ~~and~~important ~~continue~~chronic tocare ~~explore~~products ~~opportunities~~and ~~beyond~~emergency ~~injectable~~rescue ~~drugs~~therapies that ~~may~~can ~~complement~~be ~~our~~administered ~~strategy~~only ~~and~~by ~~leverage our capabilities~~injection. We ~~pursue~~believe ~~these opportunities both on~~ our ~~own~~advanced orinjection ~~with~~technologies ~~industry~~uniquely ~~leading~~address ~~partners.~~these Wemarket ~~believe~~needs ~~this~~and ~~strategy~~are ~~offers~~well asuited ~~distinct~~for ~~value~~both tothe ~~patients,~~branded ~~healthcare providers, pharmaceutical partners~~ and ~~our~~generic ~~shareholders~~marketplace.

~~Injection~~We isand aour ~~common~~partners ~~drug~~have ~~delivery~~historically ~~pathway~~sought, and are in the ~~delivery~~process of ~~pharmaceutical~~seeking, ~~therapies~~FDA ~~through~~approval ~~injection~~for ~~systems~~certain ~~often~~product ~~improves~~candidates ~~the~~primarily ~~systemic~~using ~~bioavailability~~the of505(b)(2) ~~those~~NDA ~~treatments~~(New byDrug ~~overcoming~~Application) ~~absorption~~or ~~barriers~~ANDA ~~common~~(Abbreviated ~~with~~New ~~oral~~Drug ~~and,~~Application) inapproval ~~some cases~~pathways, ~~transdermal~~as ~~delivery.~~well ~~Improved~~as ~~bioavailability~~more isrecently ~~considered beneficial when evaluating~~ the ~~role~~505(b)(1) ofNDA ~~route~~pathway ofwith ~~administration~~certain onpartners, ~~pharmaceutical~~which ~~efficacy.~~are Wefurther ~~believe~~described ~~that~~in ~~our~~the ~~advanced~~“Government ~~injection~~Regulation” ~~technology~~section ~~platforms~~below ~~provide~~included ~~drug delivery solutions that can result~~ in ~~improved~~Item ~~safety~~1 ~~and~~of ~~efficacy,~~Part ~~reduced~~I ~~side~~of ~~effects,~~this ~~and~~Annual ~~enhanced~~Report ~~patient~~on ~~comfort~~Form ~~and adherence~~10-K. ~~Many~~ ~~pharmaceutical~~Our ~~companies~~technology ~~focus~~platforms onallow ~~the~~for ~~development~~device ofcustomization, ~~important~~which ~~chronic care products and emergency rescue therapies that~~ can beprovide ~~administered~~multiple ~~only~~opportunities byin ~~injection. We~~both ~~believe~~the ~~our~~505(b)(2) ~~advanced~~NDA ~~injection~~and ~~technologies~~generic ~~uniquely address these~~ market ~~needs~~spaces, ~~and~~as ~~are~~ well ~~suited~~as ~~for both~~ the ~~branded~~505(b)(1) ~~and~~NDA ~~generic marketplace~~pathway.

WeAccording ~~and~~to ~~our~~a Market ~~partners~~Research ~~have historically sought~~Engine report, ~~and~~it ~~are~~is inestimated that the ~~process~~global ofinjectable ~~seeking,~~drug ~~FDA~~delivery ~~approval~~market ~~for~~will ~~certain~~grow ~~product~~to ~~candidates~~$1.3 ~~primarily~~billion ~~using~~by ~~the~~2024, ~~505(b)(2)~~representing ~~NDA~~a ~~(New~~compounded ~~Drug~~annual ~~Application)~~growth orrate ~~ANDA~~of ~~(Abbreviated~~12.9% ~~New~~in ~~Drug~~the ~~Application)~~forecast ~~approval~~period. This ~~pathways,~~expected asgrowth ~~well~~is asattributable ~~more~~to ~~recently~~several ~~the~~factors, ~~505(b)(1)~~including label ~~NDA~~expansion ~~pathway~~for ~~with~~approved ~~certain partners~~products, ~~which~~increasing ~~are further described in~~ the ~~“Government~~patient ~~Regulation”~~pool ~~section~~for ~~below.~~such ~~Our~~products, ~~technology~~a ~~platforms~~pipeline ~~allow~~of ~~for~~injectable ~~device~~medications ~~customization,~~at ~~which~~various ~~can~~stages ~~provide~~of ~~multiple~~clinical ~~opportunities~~development, inand ~~both~~ the ~~505(b)(2)~~increasing ~~NDA~~incidence ~~and~~of ~~generic~~certain ~~market~~diseases ~~spaces,~~that aswill ~~well~~necessitate as the ~~505(b)(1)~~utilization ~~NDA~~of ~~pathway.~~injectable medications.

~~According~~See toalso a“Our ~~Market~~Products” and “Research ~~Engine~~and ~~report~~Development” below, itincluded isin ~~estimated~~Item ~~that~~1 ~~the~~of ~~global~~Part ~~injectable~~I ~~drug~~of ~~delivery~~this ~~market~~Annual ~~will~~Report ~~grow~~on toForm ~~$775 billion~~10-K byfor ~~2024,~~additional ~~representing~~discussion ~~a compounded annual growth rate~~ of ~~11.5%~~market insize ~~the~~and ~~forecast~~opportunities ~~period. This~~relative ~~expected growth is attributable~~ to ~~several factors, including label expansion for approved products, increasing~~ the ~~patient~~current ~~pool~~therapeutic ~~for~~areas ~~such~~associated ~~products,~~with aour ~~pipeline~~existing ofportfolio ~~injectable medications at various stages~~ of ~~clinical~~products ~~development,~~ and ~~the~~products ~~increasing~~in ~~incidence of certain diseases that will necessitate the utilization of injectable medications~~development.

See also “Our Products” and “Research and Development” below for additional discussion of market size and opportunities relative to the current therapeutic areas associated with our existing portfolio of products and products in development.

Our Competitive Strengths

We believe our key competitive strengths are our commercial capabilities and infrastructure, proprietary injection technologies, and our ability to form significant strategic alliances with industry-leading pharmaceutical partners to develop and commercialize ~~proprietary and partnered~~ products. We also believe our management team has unique knowledge of, and experience in the drug/device combination product space ~~and~~along with navigating the related regulatory approval process, which creates opportunities for us and potential pharmaceutical partners ~~that look to us for our unique capabilities and know-how~~. Our business model for developing and commercializing proprietary and partnered products has been validated, we believe, by the successive FDA approvals of our NDAs for XYOSTED® and OTREXUP® and our ANDA for Sumatriptan Injection USP, as well as the FDA approval of Teva’s AB-rated generic version of the EpiPen®.

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Intellectual Property, Patents, Trade Secrets and Proprietary Information

We strive to protect and enhance the proprietary technologies that we believe are important to our business and rely on know-how and continuing technological innovation to develop, strengthen, and maintain our competitive position. When appropriate, we ~~actively~~ seek protection for our products and proprietary information by means of U.S. and international patents and trademarks. We currently hold a portfolio of patents with expirations ranging from 2021 to 2038, and numerous patent applications pending in the U.S. and other countries. These patents consist primarily of design, formulation and method-of-use patents.

In addition to our patents and patent applications, ~~trade~~our ~~secrets~~proprietary know-how and inventions play an important role in protecting our products and technologies, and provide protection beyond patents and regulatory exclusivity. We strive to preserve the confidentiality of our ~~trade secrets,~~ proprietary know-how and inventions by maintaining physical security of our sites and electronic security of our information technology systems. We also require all employees, contractors and third-party consultants with access to proprietary information to execute confidentiality agreements prohibiting the disclosure of confidential information to anyone outside the Company. These agreements also require disclosure and assignment to us of discoveries and inventions made by such individuals while devoted to Company-sponsored activities. Partners with which we have entered into development agreements have the right to certain technology developed in connection with such agreements.

Human Capital

We believe that our success is largely dependent upon our ability to attract and retain qualified employees. We currently have ~~approximately~~201 ~~185~~ full-time employees and 2 part-time employees, of which ~~approximately~~40 35 employees are based in our New Jersey corporate facility, 6065 employees in our Minnesota operations and 9098 ~~field-~~employees based ~~employees~~in the field. Our workforce includes ~~approximately~~108 95 employees directly involved in or supporting our commercial sales organization, 2027 in research and development, 4037 in manufacturing and quality, and 3031 in corporate and administrative functions. We are not party to any collective bargaining arrangements. Although we believe that the size of our current workforce is appropriate to achieve our objectives, we may hire additional employees with specialized expertise as we continue to grow our business. We believe that we have been successful to date in attracting skilled and experienced scientific and business professionals.

We continue to focus on building a high performing organization with an engaging work culture and have established initiatives to support this strategic priority. We perform ~~bi-annual~~periodic employee engagement surveys, set and monitor retention goals, and intend to invest in training and leadership development to cultivate our emerging leaders. Additionally, we are committed to diversity and inclusion as a core focus of our human capital strategy. We embrace differences, diversity and wevarying perspectives amongst our employee base, and are inproud to be an equal opportunity employer. We do not discriminate based on race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, military or veteran status, sexual orientation or any other protected characteristic established by federal, state or local laws. A diverse workforce, as well as an inclusive culture and work environment, are fundamentally important and strategic to us, beginning with our Board of Directors and extending to all levels of the ~~process~~organization. As of ~~developing~~December 31, 2021, our total employee base was 56% diverse on the basis of gender and ~~implementing~~race. We also have implemented company-wide diversity and inclusion training.

We strongly believe that the success of Antares depends, in part, on open and regular communication with employees to help foster a high performing and engaged workforce. To help ensure that employees fully understand the Company’s long -term strategy and annual goals, ~~and~~along with how their work contributes to the Company’s success, we ~~utilize~~use a variety of channels to facilitate open and direct communication, including: (i) quarterly CEO Town Hall meetings; (ii) regular ongoing update communications; and (iii) employee engagement surveys.

~~The~~We ~~Company’s~~believe ~~compensation~~our ~~philosophy~~success depends upon our ability to attract and retain highly qualified employees. Talent management and leadership development is critical to ~~pay~~our ~~for~~ability ~~performance,~~to ~~support~~execute ~~the~~on ~~Company’s~~our ~~business~~long-term ~~strategies~~growth strategy. We strive to provide pay, benefits, and ~~offer~~services that are competitive ~~compensation~~to ~~arrangements~~market and create incentives to attract and retain ~~key~~employees. ~~individuals~~Our compensation package includes market-competitive pay, discretionary broad-based stock grants and ~~has~~bonuses, ~~established~~health acare ~~Compensation~~and ~~Committee~~retirement ofbenefits, ~~the~~paid ~~Board~~time ofoff ~~Directors~~and family leave. ~~Consistent~~We also continue to advance transparency in our pay and representation data by complying with ~~this~~all ~~philosophy,~~applicable ~~the~~statutory ~~Compensation~~filing ~~Committee~~requirements. ~~considers~~To help support the ~~impact~~development and advancement of our ~~corporate~~high ~~performance~~performing inemployees, ~~determining~~we ~~compensation~~offer ~~for~~training ~~named~~and ~~executive~~development ~~officers,~~programs asencouraging ~~well~~advancement asfrom ~~each~~within ~~named~~and ~~executive~~continue ~~officer’s~~to ~~individual~~fill ~~performance,~~our ~~macroeconomic~~team ~~conditions~~with ~~generally~~strong and experienced management talent. We leverage both formal and informal programs to identify, foster, and ~~data~~retain ~~from~~top ~~peer~~talent ~~group~~throughout ~~companies~~the organization.

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Our compensation philosophy is to pay for performance, support the Company’s business strategies, and offer competitive compensation arrangements to attract and retain key individuals and therefore, have established a Compensation Committee of the Board of Directors. Consistent with this philosophy, the Compensation Committee considers the impact of our corporate performance in determining compensation for named executive officers, as well as each named executive officer’s individual performance, macroeconomic conditions, and data from peer group companies.

Our Technology and Product Platforms

Pressure assisted auto injection is a form of parenteral drug delivery that continues to gain acceptance and demand among the medical and patient community. Encompassing a wide variety of sizes and designs, our technology operates by using pressure to force the drug, in solution or suspension, through the skin and deposits the drug into the subcutaneous or intramuscular tissue. We have designed disposable, pressure assisted auto injector devices to address acute and chronic medical needs, such as rheumatoid arthritis and psoriasis, allergic reactions, migraine headaches, testosterone deficiency and maternal health. Our current platforms include the VIBEX® and the VIBEX® QuickShot® disposable pressure assisted auto injection systems, the Vai™ auto injector and disposable pen injection systems.

VIBEX® Auto Injectors

Our proprietary VIBEX® disposable auto injector systems combine a spring-based power source with a shielded needle, which delivers the needed drug solution subcutaneously or intramuscularly. InTo ~~order to~~ minimize the anxiety and perceived pain associated with injection-based technologies, the VIBEX® system features a triggering collar that shields the needle from view. The patented retracting collar springs back and locks in place as a protective needle guard after the injection, making the device safe for general disposal. We believe the key competitive advantages of the VIBEX® system include: reliable subcutaneous or intramuscular injection, designed to work with conventional pre-filled syringes, rapid injection with ability to deliver viscous solutions, ease of use in emergencies, and reduced pain.

The primary goal of the VIBEX® disposable pressure assisted auto injector is to provide a fast, safe, and time-efficient method of self-injection. This device is designed around conventional single dose pre-filled syringes, which is a primary drug container, offering ease of transition for potential pharmaceutical partners. Our proprietary product OTREXUP® (product line, excluding the NDA, sold to Otter in December 2021) uses the VIBEX® auto injector system for delivery of methotrexate. We also have two license agreements with Teva for our VIBEX® system, one for Teva’s generic epinephrine auto injector and the other for our Sumatriptan Injection USP.

VIBEX® QuickShot® Auto Injectors

An advancement of our proprietary line of VIBEX® auto injectors is the VIBEX® QuickShot® auto injector system, which offers a dose capacity of 1 mL or greater in a compact design. VIBEX® QuickShot® is designed to enhance performance on the attributes we believe most critical to patient acceptance, which are speed, comfort and discretion. VIBEX® QuickShot® achieves these advancements by incorporating a novel triggering mechanism and space-saving spring configuration. The unique design also accommodates fast injection of highly viscous drug products that less-powerful conventional auto injectors are typically unable to deliver. Many self-injectable drugs that are currently marketed or in clinical development are of higher viscosity and are formulated to be administered in a 1 mL dose volume. Our proprietary product XYOSTED®, and the Makena® subcutaneous auto injector that we developed with our partner Covis, were developed using the VIBEX® QuickShot® auto injector platform. We also have a development agreement with Pfizer to develop a rescue pen utilizing our VIBEX® QuickShot® auto injector system with an undisclosed Pfizer drug. In addition, we have a development agreement with Idorsia for a drug device combination product using a variation of our VIBEX® QuickShot® auto injector device with a new chemical entity selatogrel which is being developed for the treatment of acute myocardial infarction.

7Vai™ Auto Injector

~~accommodates~~We ~~fast~~developed ~~injection~~the ofversatile ~~highly~~Vai™ ~~viscous drug products that less-powerful conventional~~ auto ~~injectors~~injector ~~are~~platform ~~typically unable~~ to ~~deliver. Many~~meet ~~self-injectable~~evolving ~~drugs~~market ~~that~~needs. ~~are~~The ~~currently~~Vai™ ~~marketed~~auto orinjector inbuilds ~~clinical~~off ~~development~~the ~~are~~capabilities of ~~higher~~our ~~viscosity~~ VIBEX® and ~~are~~QuickShot® ~~formulated~~platforms toadding beautomatic ~~administered~~needle ininsertion, asubcutaneous 1or mLintramuscular ~~dose~~injections ~~volume.~~of ~~Our~~up ~~proprietary~~to ~~product~~1 ~~XYOSTED®,~~inch and ~~the~~delivered ~~Makena®~~volumes ~~subcutaneous~~of ~~auto~~up ~~injector~~to ~~that~~2 wemL. ~~developed~~The ~~with~~Vai™ ~~our~~auto ~~partner~~injector ~~AMAG,~~can ~~were~~accommodate ~~developed~~1 ~~using~~mL ~~the~~standard, ~~VIBEX®~~1 ~~QuickShot®~~mL ~~auto~~long, ~~injector~~and ~~platform~~2.25 WemL ~~also~~syringes. ~~have~~The aauto-insert ~~development~~technology ~~agreement~~is ~~with~~intended ~~Pfizer~~ to ~~develop~~improve acompliance ~~rescue~~for ~~pen~~drug ~~utilizing~~products ~~our~~requiring ~~VIBEX®~~deep ~~QuickShot®~~intramuscular ~~auto~~injections. This ~~injector~~innovative ~~system~~device ~~with~~is aneasily ~~undisclosed~~convertible ~~Pfizer~~to ~~drug,~~different ~~and~~fill avolumes ~~development~~and ~~agreement~~needle ~~with~~lengths ~~Idorsia~~and ~~for~~was adesigned ~~drug~~specifically ~~device~~to ~~combination~~meet ~~product~~the ~~utilizing~~reliability arequirements ~~variation~~for ofemergency ~~our~~use ~~VIBEX®~~applications ~~QuickShot®~~while ~~auto~~maintaining ~~injector~~the ~~device~~simple ~~with~~and aintuitive ~~new~~two-step ~~chemical~~process ~~entity~~of ~~selatogrel,~~administration ~~being~~of ~~developed for~~ the ~~treatment of acute myocardial infarction~~QuickShot® device.

~~Auto-Insert Injection Technology~~11

WeTable ~~have recently developed a new and versatile auto injector system to meet evolving market needs. The Auto-Insert device builds off the capabilities~~ of our VIBEX® platform adding automatic needle insertion, subcutaneous or intra-muscular (“IM”) injections of up to 1 inch and delivered volumes of up to 2 mL. This new device can accommodate 1 mL standard, 1 mL long, and 2.25 mL syringes. The auto-insert technology is intended to improve compliance for drug products requiring deep IM injections. This new device is easily convertible to different fill volumes and needle lengths and was designed specifically to meet the reliability requirements for emergency use applications while maintaining the simple and intuitive two-step process of administration of the VIBEX® device.Contents

Pen Injector System

Our multi-dose, disposable pen injector technology complements our portfolio of single-use pressure assisted auto injector devices. The disposable pen injector ~~device~~devices isare designed to deliver drugs by injection through needles from multi-dose cartridges. Our disposable pen ~~injector~~injectors isare designed for chronic conditions such as diabetes, which require daily injection of a product. Depending on dosage, our pens can deliver up to thirty days of drug. We have licensed our pen injector device technology to Teva for two ~~potential~~ products in late-stage development: (i) a multi-dose pen with teriparatide for the treatment of osteoporosis (a generic form of Forteo®); and (ii) a multi-dose pen with exenatide for the treatment of diabetes (a generic version of BYETTA®). On February 25, 2022, Teva notified us that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022.

Our Products

The following is a discussion of our approved and marketed commercial products, including proprietary and partnered products. For a discussion of other product candidates currently with tentative approval or in development, see the “Products with Tentative Approval” and “Research and Development” ~~section~~sections below included in Item 1 of Part I of this Annual Report on Form 10-K.

XYOSTED® (testosterone enanthate) ~~injection~~ Injection

~~XYOSTED®~~We ~~(testosterone~~market ~~enanthate)~~and ~~injection~~sell isin the U.S. our proprietary product XYOSTED® (testosterone enanthate) injection for subcutaneous administration of testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED®, ~~which~~ is ~~currently marketed and sold in~~ the ~~U.S., is the~~ only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration and is approved and marketed in three dosage strengths, 50 mg, 75 mg and 100 mg. XYOSTED® provides an easy and virtually pain-free administration, low risk of transference and the ability to achieve and maintain steady levels of testosterone.

In the U.S., there are several different formulations for TRT including intramuscular injection, ~~topical~~transdermal patches and gels, oral formulations and nasal gels. According to IQVIA National Sales Perspectives® (“NSP”) reporting of nationally projected sales activities, the overall U.S. TRT market was approximately $1.4 billion in ~~2020~~2021 based on wholesale acquisition costs (“WAC”). Total prescriptions in the U.S. TRT market grew by 65.81% to 78.60 million prescriptions in ~~2020~~2021 as compared to ~~2019~~2020, entirely driven by an increase in prescriptions of injectables, which increased by 75.34%. The injectable TRT market grew from $~~411~~484.74 million in ~~2019~~2020 to $~~480~~545.70 million in ~~2020~~2021, an increase of 1612.85% based on WAC. As of December ~~2020~~2021, XYOSTED® commanded approximately 5165% and 4352% of the branded TRT market among Urologists and Endocrinologists, respectively.

Competition in the U.S. testosterone replacement market includes ~~topical~~transdermal solutions such as ~~Abbvie~~AbbVie’s Androgel® 1% and ~~Androgel®~~ 1.62%, Perrigo’s generic Androgel® Topical Gel, 1.62% ~~testosterone topical gel~~, Eli Lilly’s Axiron®, Endo’s ~~Fortesta~~Testim® and ~~Testim~~Fortesta® (and the authorized generic) and Allergan plc’s (“Allergan”) Androderm®. Other forms of TRT include injectables, such as Endo’s Aveed®, Pfizer’s Depo®-Testosterone, and several generic ~~testosterones in~~ oil testosterone products sold by Actavis, Sandoz, ~~Mylan (now a part of~~ Viatris Inc.), Teva and others, as well as Testopel® pellets by Endo. ~~Clarus~~and ~~Therapeutics (“Clarus”) launched Jatenzo~~JATENZO®, an oral formulation, ofby ~~testosterone~~Clarus. ~~undecanoate~~In addition, ~~and~~Marius ~~Lipocine,~~Pharmaceuticals ~~Inc.~~has ~~(“Lipocine”)~~submitted ~~recently~~an ~~received~~NDA ~~tentative~~with the FDA ~~approval~~ for Kyzatrex, an oral formulation of testosterone ~~undecanoate~~, ~~Tlando®.~~that is pending FDA approval.

8OTREXUP® (methotrexate) Injection

Prior to December 2021, we marketed and sold in the U.S. our proprietary product OTREXUP® (methotrexate) injection. OTREXUP® is a subcutaneous methotrexate injection for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis (“RA”), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.

WeIn ~~market~~December ~~and~~2021, ~~sell~~we sold certain assets used in the ~~U.S.~~operation ~~our~~of ~~proprietary~~the ~~product~~ OTREXUP® product to Otter under an Asset Purchase Agreement for a total purchase price of $44.0 million (~~methotrexate~~the “Asset Purchase Agreement”), ~~injection~~subject to finalization of changes in closing inventory to be transferred. ~~OTREXUP®~~Pursuant isto a ~~subcutaneous~~separate ~~methotrexate~~supply ~~injection~~agreement, Otter is responsible for ~~once~~supplying ~~weekly~~the ~~self~~pre-~~administration~~filled ~~with~~syringe anof ~~easy-~~methotrexate and we will continue to~~-use,~~ ~~single~~manufacture ~~dose,~~and ~~disposable~~oversee ~~auto~~the ~~injector~~assembly and packaging of the final product which is sold to Otter as a partnered product. Further, ~~indicated~~we ~~for~~entered ~~adults~~into a license agreement with ~~severe~~Otter ~~active~~in ~~rheumatoid~~which ~~arthritis~~we ~~(“RA”)~~granted Otter a worldwide, ~~children~~exclusive, ~~with~~fully ~~active~~paid-up ~~polyarticular~~license ~~juvenile~~to ~~idiopathic~~certain ~~arthritis~~patents ~~and~~relating ~~adults~~to ~~with~~OTREXUP® ~~severe~~that ~~recalcitrant~~may ~~psoriasis. We~~also ~~currently~~relate ~~market~~to ~~seven~~our ~~dosage~~other ~~strengths~~products offor Otter to commercialize and otherwise exploit OTREXUP® in the Ufield as defined in the license agreement.S.

According to the Arthritis Foundation, RA affects approximately 1.5 million Americans. Methotrexate is considered the first-line disease modifying anti-rheumatic drug (“DMARD”) prescribed to patients with RA according to the Johns Hopkins Arthritis Center. Methotrexate is usually started at 12.5 mg, to 15 mg given orally, once-a-week, and titrated up for greater therapeutic effect, or until the patient incurs side effects. The maximum dose given is generally 25 mg per week (10, 2.5 mg tablets given in one dose). Studies have reported as many as 30% to 60% of patients experience gastrointestinal side effects with oral methotrexate, preventing further dose escalation or requiring discontinuation in some patients. Also, the extent of oral absorption of methotrexate varies considerably between patients. We believe that OTREXUP® offers physicians and patients an important alternative to oral methotrexate tablets and vials of the injectable form of the drug administered with a needle and syringe. OTREXUP® provides physicians and patients a convenient, practical and virtually painless option for administering parenteral methotrexate as an alternative to proceeding directly from oral methotrexate to biologics. Additionally, OTREXUP® is a self-contained injection device designed to minimize accidental contact with methotrexate, a hazardous drug agent.

~~Medexus~~Table ~~Pharma markets and sells Rasuvo®, a once-weekly, subcutaneous, single-dose auto-injector~~ of methotrexate indicated for the treatment of rheumatoid arthritis, psoriasis and juvenile idiopathic arthritis (JIA), which is a direct competitor to OTREXUP®. Cumberland Pharmaceuticals, Inc. also recently received FDA approval and launched RediTrex®, a methotrexate injection in the U.S. Competition in the methotrexate market also includes tablets and parenteral dosage forms that are distributed in the U.S. by several generic manufacturers, including Teva, Pfizer, Inc. (“Pfizer”), Viatris Inc. (“Viatris”), Hospira and Accord Healthcare. Beyond DMARDs, other commonly used pharmaceutical treatments for rheumatoid arthritis include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids and biologic response modifiers. In addition to methotrexate, the other DMARDs include azathioprine (Imuran®), cyclosporine (Neoral®), hydroxychloroquine (Plaquenil®), auranofin (Ridaura®), leflunomide (Arava®) and sulfasalazine (Azulfidine®). The biologic response modifiers include etanercept (Enbrel®), adalimumab (Humira®), golimumab (Simponi®), tocilizumab (Actemra®), certolizumab (Cimzia®), infliximab (Remicade®), abatacept (Orencia®), and rituximab (Rituxan®). Contents

~~NOCDURNA~~The primary competitor in the RA market is Medexus Pharma which markets and sells Rasuvo®, a once-weekly, subcutaneous, single-dose auto-injector of methotrexate indicated for the treatment of rheumatoid arthritis, psoriasis and juvenile idiopathic arthritis (~~desmopressin~~JIA), ~~acetate~~which is a direct competitor to OTREXUP®. Cumberland Pharmaceuticals, Inc. also recently received FDA approval and launched RediTrex®, a methotrexate injection in the U.S. Competition in the methotrexate market also includes tablets and parenteral dosage forms that are distributed in the U.S. by several generic manufacturers, including Teva, Pfizer, Viatris Inc. (“Viatris”), ~~Sublinqual~~Hospira ~~Tablets~~and Accord Healthcare. Beyond disease modifying anti-rheumatic drugs (“DMARDs”), other commonly used pharmaceutical treatments for rheumatoid arthritis include analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids and biologic response modifiers. In addition to methotrexate, the other DMARDs include azathioprine (Imuran®), cyclosporine (Neoral®), hydroxychloroquine (Plaquenil®), auranofin (Ridaura®), leflunomide (Arava®) and sulfasalazine (Azulfidine®). The biologic response modifiers include etanercept (Enbrel®), adalimumab (Humira®), golimumab (Simponi®), tocilizumab (Actemra®), certolizumab (Cimzia®), infliximab (Remicade®), abatacept (Orencia®), and rituximab (Rituxan®).

~~We market and sell~~ NOCDURNA® (desmopressin acetate) inSublingual the United States, which is the first and only sublingual tablet indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. NOCDURNA® is a sublingual tablet, marketed in two dosage strengths, that dissolves quickly under the tongue without water and has been shown in clinical studies to reduce nighttime urination by nearly half (in patients who average 3 nighttime bathroom visits.) We license NOCDURNA® from Ferring Pharmaceuticals. We began detailing NOCDURNA® in in the fourth quarter of 2020 and are currently in the process of re-launching the product with a comprehensive strategy to increase awareness and demand.Tablets

ItWe ismarket ~~estimated~~and ~~that~~sell ~~more~~NOCDURNA® (desmopressin ~~than~~acetate) ~~40 million people~~ in the U.S., ~~are~~which ~~affected~~is bythe ~~nocturia,~~first orand ~~frequent~~only ~~waking~~sublingual attablet ~~night~~indicated for the treatment of nocturia due to ~~urinate. Of~~nocturnal ~~the~~polyuria ~~approximately~~(“NP”) 10in ~~million~~adults ~~patients~~who ~~diagnosed~~awaken ~~with~~at ~~nocturia,~~least ~~only~~two ~~about~~times 1per night to urinate.5 ~~million~~NOCDURNA® is ~~are~~a ~~treated~~sublingual ~~for~~tablet, ~~the~~marketed ~~condition.~~in ~~One~~two ofdosage ~~the~~strengths, ~~leading~~that ~~causes~~dissolves ofquickly ~~nocturia~~under isthe ~~nocturnal~~tongue ~~polyuria,~~without ~~which~~water isand ~~present~~has been shown in upclinical studies to ~~88%~~reduce ofnighttime ~~nocturia~~urination ~~patients.~~by Innearly ~~patients~~half ~~diagnosed~~(in ~~with~~patients ~~nocturnal~~who ~~polyuria,~~average ~~the~~three ~~kidneys~~nighttime ~~produce~~bathroom ~~too~~visits.) ~~much~~We ~~urine~~license atNOCDURNA® from ~~night~~Ferring. We ~~Patients~~began ~~may~~detailing ~~already~~NOCDURNA® with bea ~~taking~~soft ~~medication~~launch ~~for~~in ~~overactive~~the ~~bladder~~fourth ~~(OAB)~~quarter orof ~~benign~~2020 ~~prostatic~~and ~~hyperplasia~~reintroduced ~~(BPH);~~the ~~however,~~product ~~these~~through ~~medications~~a ~~may~~re-launch ~~not~~strategy ~~reduce~~to ~~night-time~~increase ~~urination~~awareness ~~because~~and ~~they~~demand doin ~~not~~the ~~treat~~first ~~NP.~~quarter of 2021.

~~Pharmacological~~It ~~therapy~~ is ~~most~~estimated ~~useful~~that more than 50 million people in ~~treating~~the ~~nocturia~~U.S. ~~due~~are toaffected ~~nocturnal~~by ~~polyuria~~nocturia, ~~including~~or ~~desmopressin,~~frequent anwaking ~~anti-diuretic~~at ~~hormone~~night ~~therapy~~to urinate. Of ~~The~~the ~~antidiuretic~~approximately ~~effects~~10 ofmillion ~~desmopressin~~patients ~~are~~diagnosed ~~mediated~~with bynocturia, ~~stimulation~~only ofabout ~~vasopressin~~1.5 2million ~~(V2)~~are ~~receptors,~~treated ~~thereby~~for ~~increasing~~the ~~water~~condition. ~~re-absorption~~One inof the ~~kidney~~leading causes of nocturia is nocturnal polyuria, ~~and~~which ~~hence~~is ~~reducing~~present ~~urine~~in ~~production~~up to 88% of nocturia patients. ~~Desmopressin~~In ispatients ~~available~~diagnosed aswith ~~both~~nocturnal anpolyuria, ~~oral~~the ~~tablet~~kidneys ~~and~~produce atoo ~~nasal~~much ~~spray~~urine at night. ~~Noctiva™,~~Patients anmay ~~FDA-approved~~already ~~nasal~~be ~~formulation~~taking ofmedication ~~desmopressin~~for ~~acetate,~~overactive ~~although~~bladder ~~not~~(“OAB”) ~~currently~~or ~~marketed~~benign inprostatic ~~the~~hyperplasia ~~U.S.~~(“BPH”); however, isthese ~~the~~medications ~~only~~may ~~other~~not ~~FDA~~reduce night-~~approved~~time ~~branded~~urination ~~desmopressin~~because ~~acetate~~they ~~indicated~~do ~~for~~not ~~the~~treat ~~treatment of nocturia~~NP.

Pharmacological therapy is most useful in treating nocturia due to nocturnal polyuria, including desmopressin, an anti-diuretic hormone therapy. The anti-diuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (“V2”) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin is available as both an oral tablet and a nasal spray. Noctiva™, an FDA-approved nasal formulation of desmopressin acetate, although not currently marketed in the U.S., is the only other FDA-approved branded desmopressin acetate indicated for the treatment of nocturia.

Epinephrine Injection USP

We ~~developed and~~ are the exclusive supplier of the device, which we developed, for Teva’s generic Epinephrine Injection USP products, indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Teva’s Epinephrine Injection, utilizing our patented VIBEX® injection technology, was approved by the FDA ~~in August 2018~~ as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to the branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, substitutable at the pharmacy. ~~Teva announced a limited commercial launch of its generic epinephrine product in late fourth quarter of 2018 with full commercial availability in 2019.~~ We supply the device and Teva is responsible for the drug, assembly and packaging, distribution and commercialization of the finished product, for which we also receive royalties on Teva’s net sales.

9Epinephrine is used for the treatment of severe allergic reactions (anaphylaxis) to insect venom, foods, drugs and other allergens as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis. Viatris’s EpiPen®, along with its own authorized generic of the product, continues to be the global market leader in the epinephrine auto injector market. In the U.S., sales of generic epinephrine injection products were approximately $1.66 billion in 2021 based on WAC, according to the IQVIA NSP report. There are other companies and alternative products competing in the U.S. market, including the authorized generic for Adrenaclick® marketed by Amneal Pharmaceuticals, Inc. and Kaléo’s AUVI-Q® (Epinephrine Injection, USP). Auto-Injector in the U.S. beginning in February 2017, Adamis Pharmaceuticals also received FDA approval of SYMJEPI®, an epinephrine injection, which is marketed and distributed in the U.S. by US WorldMeds LLC.

Epinephrine is utilized for the treatment of severe allergic reactions (anaphylaxis) to insect venom, foods, drugs and other allergens as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis. Viatris’s EpiPen®, along with its own authorized generic of the product, continues to be the global market leader in the epinephrine auto injector market. In December 2016, Viatris announced the availability of its lower-priced authorized generic to EpiPen®, intended to address pricing concerns of the branded version. In the U.S., sales of generic epinephrine injection products were approximately $1.1 billion in 2020 based on WAC, according to the IQVIA NSP report. There are other companies and alternative products competing in the market, including the authorized generic for Adrenaclick® manufactured by Impax Laboratories LLC, a subsidiary of Amneal Pharmaceuticals LLC. Kaléo also announced the availability of AUVI-Q® (Epinephrine Injection, USP) Auto-Injector in the U.S. beginning in February 2017, and Adamis Pharmaceuticals received FDA approval of SYMJEPI™, an epinephrine injection, which is marketed and distributed in the U.S. by US WorldMeds LLC. 13

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Sumatriptan Injection USP

We, through our partner Teva, sell Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine headaches and cluster headache in adults. Sumatriptan Injection USP is a generic equivalent to Imitrex® STATdose Pen®, and available in the 4 mg/0.5 mL and 6 mg/0.5 mL single-dose ~~prefilled~~pre-filled syringe auto-injectors. We have a license, supply and distribution agreement with Teva, under which Teva is responsible for the manufacture and supply of the drug, and we manufacture the device and complete assembly and packaging of the finished product. Teva is responsible for commercialization and distribution.

The total U.S. retail anti-migraine triptan market was $4.59 billion in ~~2020~~2021 according to IQVIA’s National Prescription Audit® (“NPA”) report based on TRx Pharmacy Dollars. The majority of patients who use triptans take oral tablets. Oral drugs accounted for $4.14 billion of the total, and injectable products accounted for approximately $~~264~~257 million of the total market, measured in terms of TRx Pharmacy Dollars. Sumatriptan is currently available in an oral formulation, a nasal spray ~~(Imitrex, GSK~~ and ~~generic) and a needleless injector (Sumavel, Astellas/Zogenix)~~injectable. There is extensive competition in the ~~sumatriptan~~anti-migraine marketplace and several manufacturers offer versions of injectable ~~sumatriptan~~drugs with a delivery device, including GSK (Imitrex STATdose Pen®), Teva (AJOVY®), Pfizer (Alsuma), ~~ENDO~~Endo ~~Pharmaceuticals~~International plc (Sumavel® DosePro®), Sun Pharma (generic sumatriptan autoinjector) and Upsher-Smith (Zembrace® SymTouch®). ~~One company,~~ Sandoz, Inc. (“Sandoz”) also markets an authorized generic version of GSK’s Imitrex STATdose Pen®.

Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto Injector

We ~~developed~~are the exclusive supplier of the device, a variation of our VIBEX® QuickShot® subcutaneous auto injector ~~for~~developed ~~use~~by ~~with~~us, ~~AMAG’s~~for the progestin hormone drug Makena® (hydroxyprogesterone caproate injection) ~~under an exclusive license and development agreement~~. The Makena® subcutaneous auto injector drug-device combination product is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The product was approved by the FDA inunder ~~February~~the ~~2018~~accelerated approval pathway. We are the exclusive supplier of the devices and the final assembled and packaged commercial product ~~to AMAG~~.

Makena® is a progestin that belongs to a class of drugs called progestogens. Progestogens have been studied to reduce preterm birth and have shown varying results depending upon the subjects enrolled. The active ingredient in Makena®, 17α hydroxyprogesterone caproate (often referred to as 17P), is the only FDA-approved treatment for pregnant women who have had a prior spontaneous preterm birth (which is a substantial risk factor for recurrent preterm birth) and has been and used for more than a decade by healthcare providers to treat patients with a history of spontaneous preterm birth. The approval of Makena® was based on the landmark Meis trial, conducted by the National Institute of Child Health and Human Development and the Maternal-Fetal Medicine Units Network and published in the New England Journal of Medicine in 2003. The Society for Maternal Fetal Medicine Publications Committee published clinical guidelines for the use of progestogens to reduce the risk of preterm birth in the American Journal of Obstetrics and Gynecology in May 2012, which were affirmed in 2014. Preterm birth is defined as a birth prior to 37 weeks of pregnancy being completed. According to the ~~March~~Centers offor ~~Dimes,~~Disease ~~preterm~~Control ~~births~~and ~~affected~~Prevention ~~nearly~~National ~~380,000~~Center ~~babies~~for Health Statistics, orthe ~~one~~percentage of ~~every~~preterm ~~ten~~births ~~infants~~affected ~~born~~approximately 10% of births in the ~~United~~U.S. ~~States~~in 2020.

In October 2019, ~~AMAG~~Covis announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena® (hydroxyprogesterone caproate) injection. Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena® and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. In October 2020, ~~AMAG~~Covis received notice that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). ~~AMAG~~Covis then formally requested a public hearing in response to the FDA’s proposal to withdraw its approval and has stated that it remains committed to working with the FDA to maintain patient access to Makena® as a treatment option to reduce pre-term birth. In ~~November~~August ~~2020~~2021, Covis ~~Group,~~announced athe ~~private~~FDA ~~pharmaceutical~~had ~~company~~granted ~~focused~~the onrequest ~~providing~~for ~~therapeutic~~a ~~solutions~~public hearing. A date for ~~patients~~such ~~with~~meeting ~~life-threatening~~has ~~conditions~~not ~~and~~been ~~chronic~~set ~~illnesses,~~or ~~acquired~~announced ~~AMAG~~by either the FDA or Covis.

Teriparatide Injection

We ~~developed and~~ are the exclusive supplier of the multi-dose pen, ~~utilized~~which we developed, used in Teva’s generic teriparatide injection product. In 2020, our partner Teva launched Teriparatide Injection, the generic version of Eli Lilly’s branded product Forsteo® featuring the Antares multi-dose pen platform, for commercial sale in several countries outside of the ~~United States~~U.S. Under an exclusive development, license and supply agreement with Teva, Antares is responsible for the manufacturing and supply of the multi-dose pen ~~utilized~~used in Teva’s generic teriparatide product and Teva is responsible for the sale and distribution of the product. Antares is compensated for devices sold to Teva and is entitled to receive royalties on net product sales by Teva in the territories.

Teriparatide is used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture and for glucocorticoid induced osteoporosis in men and women. According to Eli Lilly’s annual report, 2020 global sales of Forteo® was $1.05 billion, of which $510.3 million was recorded in the U.S. and $536.0 million in the rest of the world.14

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Teriparatide is used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture and for glucocorticoid induced osteoporosis in men and women. According to Eli Lilly’s annual report, 2021 global sales of Forteo® were $801.9 million, of which $441.6 million was generated in the U.S.

Products with Tentative Approval

The following is a discussion of our products with tentative approval from the FDA. For a discussion of other approved and marketed commercial products, including proprietary and partnered products and product candidates currently in development, see the “Our Products” and “Research and Development” sections above and below, respectively, included in Item 1 of Part I of this Annual Report on Form 10-K.

TLANDO® (testosterone undecanoate) Oral Formulation

TLANDO® (testosterone undecanoate) is a twice daily oral formulation of testosterone for TRT indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO® was granted tentative approval from the FDA in December 2020 and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus for JATENZO® on March 27, 2022. On February 3, 2022, we announced the FDA’s acceptance of our NDA resubmission for TLANDO® in which the FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022. We continue to prepare for the launch of TLANDO® in 2022 pending final FDA approval after the expiration of JATENZO®’s exclusivity period.

In the U.S., there are several different formulations for TRT including intramuscular injection, transdermal patches and gels, oral formulations and nasal gel. According to IQVIA National Sales Perspectives® (“NSP”) reporting of nationally projected sales activities, the overall U.S. TRT market was approximately $1.4 billion in 2021 based on wholesale acquisition costs (“WAC”). Total prescriptions in the U.S. TRT market grew by 5.1% to 8.0 million prescriptions in 2021 as compared to 2020, entirely driven by an increase in prescriptions of injectables, which increased by 5.4%. The injectable TRT market grew from $484.4 million in 2020 to $545.0 million in 2021, an increase of 12.5% based on WAC.

Competition in the U.S. testosterone replacement market includes transdermal formulations such as AbbVie’s Androgel® 1% and 1.62%, Perrigo’s generic Androgel® Topical Gel, 1.62%, Eli Lilly’s Axiron®, Endo’s Testim® and Fortesta® and Allergan plc’s (“Allergan”) Androderm®. Other forms of TRT include injectables such as Endo’s Aveed®, Pfizer’s Depo®-Testosterone, and several generic testosterone products sold by Actavis, Sandoz, Viatris Inc., Teva and others, as well as Testopel® pellets by Endo and JATENZO®, an oral formulation, by Clarus. In addition, Marius Pharmaceuticals has submitted an NDA with the FDA for Kyzatrex, an oral formulation of testosterone that is pending final approval.

Research and Development

We are committed to a strong research and development program, recognizing that the development of new product offerings is important to our future success. An important part of our growth strategy is our continued investment in our evolving research and development activities and new product pipeline. While we are focused on opportunities within urology and endocrinology therapeutic areas, we are also exploring new product opportunities beyond these therapeutic areas that could further grow and diversify our portfolio. Our research and development efforts are focused primarily on leveraging our existing product and technology platforms by broadening their applications for use in other drug/device combination products, as well as exploring new pharmaceutical products, technologies and drug delivery methods. We also have a corporate development team that ~~actively~~ seeks and evaluates new business and product opportunities to further expand our pipeline.

Our research and development programs consist primarily of clinical, regulatory, formulation development, engineering and device development activities for our current products, next generation versions of current products, product extensions, and new proprietary and partnered products and technologies in development. Our internal research and development team works with external consultants, industry experts, physicians and other medical personnel in an effort to drive our product development pipeline. The following is a discussion of our significant research and development activities.

ATRS - 1901

InWe ~~2019,~~have we initiated development of a proprietary drug device combination product for the urology oncology market, identified as ATRS-1901., Weand ~~have~~ conducted formulation development work and non-clinical studies to help advance this program. In 2020, we received a response from the FDA regarding our pre-IND (Investigational New Drug) submission and believe we have determined our clinical and regulatory pathway forward. We ~~expect~~Our topre-clinical ~~file~~safety anstudies ~~IND~~are ~~for this program with the FDA in the second half of 2021~~ongoing.

~~ATRS -1902~~15

InTable 2019, we identified a program to develop a proprietary drug device combination product for the endocrinology market, identified as ATRS-1902. We conducted initial formulation work and developed a working prototype of a new device to support this program. We received a response from the FDA regarding our pre-IND submission and believe we have determined the regulatory and clinical path forward. We expect to file an IND for this program with the FDA in the first half of 2021. Contents

ATRS - 1902

We have identified a program to develop a proprietary drug device combination product for the endocrinology market, an adrenal crisis pen, identified as ATRS-1902. The development program supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone. We have conducted initial formulation work and developed a working prototype of a new device to support this program.

In June 2021, we submitted an IND application with the FDA for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application includes the protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef®, which is an anti-inflammatory glucocorticoid and is the current standard of care for the management of acute adrenal crises.

In July 2021, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. The Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics (“PK”) of a liquid stable formulation of hydrocortisone was initiated in September 2021. The study is a cross-over design to establish the PK profile of ATRS-1902 (100 mg) compared to Solu-Cortef® (100 mg), the reference-listed drug, in 32 healthy adults. After this study is completed, we expect to conduct a bioequivalence study and second human factor study utilizing our proprietary auto-injector technology.

In January 2022, we announced the positive results from the Phase 1 clinical study and were granted Fast Track designation by the FDA. The positive results support the advancement of our ATRS-1902 development program to a pivotal study for the treatment of acute adrenal insufficiency, known as adrenal crisis, using our Vai™ novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone. We anticipate starting this pivotal study in adults in the second quarter of 2022 and expect to submit a 505(b)(2) NDA with the FDA by the end of 2022 pending the success of the study, a further human factors study and confirmation of the product stability from our ongoing stability program.

ATRS-1903

We have initiated development of a proprietary drug device combination product utilizing our rescue pen technology for a rare immunology disorder, identified as ATRS-1903. Formulation development work has been conducted and we anticipate progressing this towards initial clinical testing to evaluate PK and tolerability in human subjects.

Additional Development Programs

We continue to pursue and evaluate other potential new products and product extensions that address patient needs primarily in ~~our~~ targeted therapeutic areas. We ~~actively~~ explore new ~~options~~development ~~for~~opportunities ~~patients~~ including innovative delivery technologies and improved formulations of existing therapeutics.

Partnered Development Projects

We, in collaboration with our pharmaceutical partners, are engaged in research and development activities utilizing our auto injectors and disposable pen injectors. The development programs typically consist of determination of the device design, development of prototype tooling, production of prototype devices for testing and clinical studies, and development of commercial tooling and assembly. We expect development related to these products to continue; however, the development timelines are generally controlled by our partners and the extent of near-term and future development will be dependent on decisions made by our partners. The following is a summary of the development stages for ~~each~~select ~~of the~~ partnered products in development:

Pen Injector with Teriparatide

We are developing with Teva, under a license, development and supply agreement, a multi-dose disposable pen injector device with teriparatide for the treatment of osteoporosis. Teva is ~~actively~~ working toward a regulatory approval with the FDA for a generic version of Forteo® (teriparatide [rDNA origin] injection) using the ANDA pathway ~~and has indicated it is awaiting a potential FDA approval in 2021~~. See also the “Teriparatide Injection” section above for more information about the product and Teva’s commercialization activities outside the ~~United States~~U. S.

Pen Injector with Exenatide

We ~~are~~were ~~also~~ developing with Teva a multi-dose pen injector device for use with a generic form of BYETTA® (exenatide injection) for the treatment of diabetes. Teva iswas working through the U.S. regulatory approval process for its exenatide pen using the ANDA pathway. On February 25, 2022, Teva notified us that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022.

Exenatide, marketed as BYETTA®, is used along with diet and exercise to treat type 2 diabetes, a condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood. Exenatide works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Exenatide also slows the emptying of the stomach and causes a decrease in appetite. Exenatide is not used to treat type 1 diabetes, a condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood. Exenatide is not used instead of insulin to treat people with diabetes who need insulin. Total gross U.S. sales of BYETTA® (exenatide) by AstraZeneca in 2020 were approximately $135 million according to IQVIA NSP. BYDUREON®, a long-acting form of the medication BYETTA®, had approximately $1.2 billion in gross sales in the U.S. in 2020 based on WAC, according to IQVIA NSP.16

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Rescue Pen (drug undisclosed)

In August 2018, we entered into a development agreement with Pfizer and began developing a combination drug device rescue pen. This rescue pen will ~~utilize~~use the Antares QuickShot® auto injector and an undisclosed Pfizer drug. WeIn ~~will~~2021, ~~develop the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We entered into a separate commercial supply agreement with Pfizer pursuant to which~~ we ~~will~~continued ~~sell fully packaged commercial ready finished product~~ to ~~Pfizer,~~work ~~assuming~~on ~~FDA~~this ~~approval.~~development ~~Pfizer will be responsible for commercializing the product in the U.S.~~program, and we ~~will~~expect ~~receive~~to ~~royalties~~continue ondevelopment ~~net~~of ~~sales. We~~this ~~have~~product ~~begun design work, feasibility testing and Human Factor studies~~candidate.

Rescue Device with Selatogrel

In November 2019, we entered into a new global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. A new chemical entity, selatogrel, is being developed for the treatment of a suspected acute myocardial infarction (“AMI”) in adult patients with a history of AMI. Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which ~~Antares~~we will provide fully assembled and labelled product to Idorsia at cost plus ~~margin~~mark-up. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. ~~Antares~~We will be entitled to receive royalties on net sales of the commercial product.

In 2020, we completed the initial design phase of the selatogrel device and Idorsia conducted a clinical bridging study utilizing these devices. We completed the usability and reliability studies for the device which has been tailored for emergency use ~~to ensure safe and effective use can be demonstrated~~ ahead of the Phase 3 study.

According to publications by Idorsia, two Phase 2 studies in patients with stable coronary artery disease and acute myocardial infarction, respectively, have met their pharmacodynamic objectives of significantly inhibiting platelet aggregation. Subcutaneous administration of selatogrel 8 mg and 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the height of its effect extending over 4-8 hours, depending on the dose. Selatogrel was safe and well tolerated in both studies and there were no treatment-emergent serious bleeds.

~~Idorsia,~~ inIn ~~consultation~~December ~~with health authorities~~2020, isthe ~~preparing~~FDA todesignated ~~initiate~~Idorsia’s ainvestigation ~~large,~~of ~~international,~~selatogrel ~~multi-center,~~for ~~Phase 3 study in~~ the ~~first~~treatment ~~half~~ of ~~2021~~a ~~with~~suspected ~~approximately~~AMI ~~14,000~~in adult patients towith ~~investigate~~a ~~the~~history ~~efficacy~~of ~~and~~AMI ~~safety~~as ofa ~~subcutaneous self~~“fast-~~administration~~track” ofdevelopment ~~selatogrel~~program. ~~for~~This ~~the~~designation ~~treatment~~is ofintended ato ~~suspected~~promote ~~AMI~~communication inand ~~patients~~collaboration ~~with~~between athe ~~history~~FDA ofand ~~AMI.~~pharmaceutical ~~Participating~~companies ~~patients~~for ~~will~~drugs bethat ~~trained~~treat onserious ~~when~~conditions ~~to inject~~ and ~~instructed~~fill onan ~~how~~unmet tomedical ~~self-administer treatment~~need.

~~According~~In June 2021, Idorsia announced they initiated its Phase 3 registration study to evaluate the ~~American~~efficacy ~~Heart~~and ~~Association~~safety of self-administered subcutaneous selatogrel, ~~there~~Idorsia’s ~~are~~P2Y12 ~~currently~~receptor 8antagonist, in suspected AMI using Antares’ QuickShot® auto-injector.4 ~~million~~The ~~heart~~study ~~attack~~is ~~survivors~~an ininternational, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the Uclinical efficacy and safety of 16 mg of selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction.S The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. ~~There~~The ~~are~~study ~~also~~will enroll approximately ~~800~~14,000 ~~heart~~patients ~~attacks~~who are at high risk of recurrent AMI, at approximately 250 sites in ~~the~~approximately U30 countries.S. ~~annually~~A Special Protocol Assessment has been agreed with the FDA for Idorsia’s selatogrel, which indicates the FDA is in agreement with the adequacy and acceptability of ~~which~~specific ~~600~~critical elements of overall protocol design (e.g.,~~000~~ ~~are~~entry ~~first~~criteria, ~~heart~~dose ~~attacks~~selection, endpoints and ~~200,000~~planned ~~happen~~analyses) tofor ~~people~~a ~~who~~study ~~have~~intended ~~already~~to ~~had~~support a ~~heart~~future ~~attack~~marketing application.

12According to the American Heart Association, the overall prevalence for myocardial infarction in the U.S. is about 7.9 million adults. There are also approximately 805,000 heart attacks in the U.S. annually, of which 605,000 are first heart attacks and 200,000 happen to people who have already had a heart attack according to the Centers for Disease Control and Prevention.

Manufacturing

We use third parties to manufacture our products and product candidates~~. To~~, ~~the~~including ~~extent that we are~~ the ~~sponsor~~products ofand arelated ~~drug/device~~components ~~combination~~we ~~product~~supply ~~or product candidate or~~ to ~~the~~our ~~extent~~partners. For ~~that~~our weproducts ~~are responsible for drug~~ and ~~device operations with regard to products or~~ product candidates ~~sponsored by our partners~~, we must ensure ~~that~~they ~~the~~are ~~product or product candidate is~~ manufactured in accordance with FDA’s current Good Manufacturing Practices (“cGMPs”) for drug products and FDA’s current Quality System Regulations (“QSRs”) for medical devices and equivalent provisions in the European Union (“EU”) and elsewhere, which are required as part of the overall obligations necessary~~, in the EU for instance, to obtain a CE-mark~~. ~~To the extent that we are only supplying the device component to one of our partners, we are responsible for compliance with QSRs.~~ We believe that our third-party manufacturers are currently in compliance with cGMPs, QSRs and ~~QSRs~~foreign equivalents, to the extent applicable. Assembly and packaging of ~~all of~~ our products and product candidates is performed by third-party service providers under our direction. All manufacturers and suppliers are monitored and evaluated by our quality department to assess compliance with regulatory requirements and our internal quality standards and benchmarks. We perform quality ~~review~~reviews of manufacturing for all of our product candidates and products, and quality releases for all of our product ~~release~~candidates and products that we sponsor or commercialize.

We utilize a range of third-party manufacturers to manufacture and supply certain components, drugs, final assembly and finished product. Below is a summary of our production, manufacturing, assembly and packaging arrangements with third parties:17

•Table ~~We have contracted with Phillips-Medisize Corporation (“Phillips”), an international outsource provider~~ of design and manufacturing services, to produce clinical and commercial quantities of our VIBEX® QuickShot® auto injector device for XYOSTED®, our VIBEX® QuickShot® device for the Makena® auto injector product with AMAG, our VIBEX® epinephrine auto injector, the undisclosed rescue device under development with Pfizer and the device with selatogrel under development with Idorsia.Contents

• We ~~utilize~~use ~~ComDel~~a ~~Innovation,~~range ~~Inc.~~of ~~(“ComDel”),~~third-party amanufacturers ~~provider~~to ofmanufacture ~~integrated~~and ~~solutions~~supply ~~for~~certain ~~product development~~components, ~~tooling~~drugs, final assembly and ~~manufacturing,~~finished toproduct. Below ~~provide~~is ~~manufacturing~~a ~~services~~summary ~~for~~of ~~the~~our ~~VIBEX®~~key ~~with~~production, ~~sumatriptan~~manufacturing, ~~product~~assembly and ~~for~~packaging ~~the~~arrangements ~~teriparatide~~with ~~and~~third-party ~~exenatide~~manufacturers ~~pen~~for products ~~with~~commercialized ~~Teva.~~by us and our partners:

• We have contracted with ~~Jabil~~Phillips-Medisize ~~Healthcare~~Corporation (“~~Jabil~~Phillips”), ~~formerly~~an ~~Nypro~~international ~~Inc.~~outsource orprovider ~~“Nypro”),~~of andesign ~~international~~and manufacturing ~~development~~services, ~~company~~ to ~~supply~~produce commercial quantities of our ~~VIBEX~~QuickShot® auto ~~pressure~~injector ~~assisted~~device for XYOSTED®, our QuickShot® auto injector device for ~~our~~the ~~OTREXUP~~Makena® product with Covis, and our VIBEX® epinephrine ~~products~~auto injector product with Teva.

• We ~~have~~use ~~contracted~~ComDel ~~with~~Innovation, ~~Pharmascience~~ Inc. to(“ComDel”), ~~supply~~a ~~commercial~~domestic ~~quantities~~provider of ~~methotrexate~~integrated ~~pre-filled~~solutions ~~syringes~~for product development, tooling, and manufacturing, to provide manufacturing services for ~~OTREXUP~~the VIBEX® sumatriptan auto injector product and for the teriparatide pen product with Teva.

• We have contracted with ~~Fresenius~~Jabil ~~Kabi~~Healthcare, an international manufacturing development company to supply commercial quantities of ~~pre-filled~~our ~~syringes~~VIBEX® auto ofinjector ~~testosterone~~device for ~~XYOSTED~~the OTREXUP® product for Otter and the VIBEX® epinephrine auto injector product with Teva.

• We have contracted with ~~Ferring~~Fresenius ~~for~~Kabi ~~the~~to supply commercial ~~supply~~quantities of ~~NOCDURNA~~pre-filled syringes of testosterone for XYOSTED®.

• We ~~utilize~~have ~~various~~contracted ~~pharmaceutical~~with ~~companies~~Ferring tofor ~~supply~~ the ~~active~~commercial ~~pharmaceutical~~supply ~~ingredient~~of ~~(“API”) for XYOSTED~~NOCDURNA®~~, OTREXUP® and Sumatriptan Injection USP~~.

• We ~~utilize~~use Sharp Corporation (“Sharp”), an international contract packaging company, to assemble and package ~~OTREXUP®,~~ XYOSTED®, Sumatriptan Injection USP, and the Makena® auto injector products, and the OTREXUP® auto injector product for Otter®.

•Below ~~Our~~is ~~partner~~a ~~Teva~~summary ~~supplies~~of ~~the~~our ~~pre-filled~~key ~~syringes~~production, ~~for~~manufacturing, ~~Sumatriptan~~assembly ~~Injection~~and ~~USP.~~packaging arrangements with third-party manufacturers for TLANDO®:

•We ~~have~~use aPfizer ~~highly experienced quality group that works with and regularly inspects or meets with our manufacturers and suppliers~~ to ~~review~~supply the ~~manufacturing~~active ~~process~~pharmaceutical ~~for~~ingredient ~~our products and to provide input on quality matters~~(“API”).

In•We ~~addition~~have tocontracted ~~the~~with ~~above manufacturing capabilities~~NextPharma, onan ~~July~~international 1,pharmaceutical ~~2019, we entered into a lease for approximately 75,000 square feet of office, laboratory,~~ manufacturing ~~and warehousing space in Minnetonka~~company, ~~Minnesota.~~to ~~The~~supply ~~Company completed~~ the ~~build-out~~bulk ofcapsule ~~the facility and began occupying the space in 2020. The new facility supports our administrative functions,~~ product ~~development and quality operations and is intended to provide additional manufacturing and warehousing capabilities in the future~~.

•We use PCI Pharma Services (“PCI”), an international contract packaging company, to assemble and package TLANDO®.

We have an experienced quality group that works with and regularly inspects or meets with our manufacturers and suppliers to review the manufacturing process for our products and product candidates, and to provide input on quality matters.

In addition to the above manufacturing capabilities, on July 1, 2019, we entered into a lease for approximately 75,000 square feet of office, laboratory, manufacturing and warehousing space in Minnetonka, Minnesota. We completed the build-out of the facility and began occupying the space in 2020. The new facility supports our administrative functions, product development and quality operations and is intended to provide additional manufacturing and warehousing capabilities in the future.

Commercial Operations

We have built a robust internal commercial organization, consisting of specialty sales representatives, management and support staff, to market and sell our proprietary products XYOSTED®, OTREXUP® and NOCDURNA® in the U.S. As of December 2021, commercialization and distribution of OTREXUP® is the responsibility of Otter in accordance with the Asset Purchase Agreement. In anticipation of final FDA approval, we are preparing to launch TLANDO® in 2022. We have entered into agreements with vendors for certain commercialization services such as third-party logistics, distribution, data analytics and claims processing. We have and may continue to enter into licensing and or additional distribution arrangements for commercialization of our products outside the U.S.

1318

~~Distribution~~Table – We have contracted with a third-party logistics provider, Cardinal Health 105, Inc., also known as Specialty Pharmaceutical Services (“Cardinal”), for key services related to logistics, warehousing and inventory management, distribution, contract administration and chargeback processing, accounts receivable management and call center management. We also utilize a division of Cardinal for sample administration. In addition, we utilize third parties to perform various other services for us relating to regulatory monitoring, including adverse event reporting, safety database management and other product maintenance services.Contents

~~Trade~~Distribution – We ~~contract~~have contracted with ~~numerous~~a ~~wholesale~~third-party ~~distributors~~logistics provider, ~~including~~ Cardinal Health 105, ~~McKesson~~Inc., ~~Corporation~~also known as Specialty Pharmaceutical Services (“~~McKesson~~Cardinal”), ~~and~~for ~~Amerisource~~key ~~Bergen~~services ~~Corporation~~related to ~~distribute our XYOSTED®~~logistics, ~~OTREXUP®~~warehousing and ~~NOCDURNA®~~inventory ~~products~~management, todistribution, ~~the~~contract ~~retail~~administration ~~pharmacies~~and aschargeback ~~well~~processing, asaccounts ~~the~~receivable ~~Veterans~~management ~~Administration~~ and ~~other~~call ~~governmental~~center ~~agencies~~management. In ~~addition~~We toalso ~~shipping~~use ~~our~~a ~~product,~~division ~~these~~of ~~distributors~~Cardinal ~~provide~~for ~~inventory~~sample ~~and sales reports as well as other services~~administration. In ~~exchange for these services~~addition, we ~~pay~~use ~~fees~~third parties to ~~certain~~perform ~~distributors~~various ~~based~~other onservices afor ~~percentage~~us ofrelating ~~wholesale~~to ~~acquisition~~regulatory ~~cost.~~monitoring, Weincluding ~~have~~adverse ~~also~~event ~~contracted~~reporting, ~~with~~safety ~~several~~database ~~specialty~~management ~~pharmacies~~and toother ~~support~~product ~~fulfillment~~maintenance ~~of certain prescriptions~~services.

~~Third~~Trade ~~Party Reimbursement and Pricing~~ – We Incontract ~~the~~with ~~U.S.~~numerous ~~and~~wholesale ~~elsewhere~~distributors, ~~sales~~including ofCardinal, ~~pharmaceutical~~McKesson ~~products~~Corporation to(“McKesson”) ~~consumers~~and ~~depend~~AmerisourceBergen Corporation to adistribute ~~significant~~our ~~degree~~proprietary products onto ~~the~~retail ~~availability~~pharmacies ofas ~~coverage~~well ~~and~~as ~~reimbursement~~the byVeterans ~~third-party~~Administration ~~payers, such as government~~ and ~~private~~other ~~insurance~~governmental ~~plans~~agencies. In ~~Third-party~~addition ~~payers~~to ~~are~~shipping ~~increasingly~~our ~~challenging~~product, ~~the~~these ~~pricing~~distributors ofprovide ~~products~~inventory and ~~services~~sales ~~and~~reports ~~implementing~~as ~~other~~well ~~cost~~as ~~containment~~other ~~mechanisms,~~services. In ~~including~~exchange ~~demanding more aggressive pricing and rebates~~ for ~~favorable~~these ~~formulary~~services, ~~placement.~~we ~~This~~pay isfees ~~especially~~to ~~true~~certain indistributors ~~markets~~based ~~where~~on ~~generic options exist. Third-party payers often utilize~~ a ~~tiered~~percentage ~~reimbursement~~of ~~system~~wholesale ~~and~~acquisition ~~may require step edits or prior authorization~~cost. ItWe ~~is,~~have ~~and~~also ~~will~~contracted ~~continue~~with toseveral ~~be,~~specialty ~~time~~pharmacies ~~consuming and expensive for us~~ to ~~seek~~support ~~and~~fulfillment ~~maintain~~of ~~coverage~~certain ~~for our products and to process reimbursements from Medicaid, Medicare and private payers~~prescriptions.

~~Some~~Third ~~states~~Party ~~have~~Reimbursement ~~also~~and ~~created~~Pricing ~~Medicaid~~– In ~~preferred~~the ~~drug~~U.S., ~~lists~~sales ~~and~~of ~~include~~pharmaceutical ~~drugs~~products onto ~~those~~consumers ~~lists~~depend ~~only~~to ~~when~~a significant degree on the ~~manufacturers~~availability ~~agree~~of tocoverage ~~pay~~and areimbursement ~~supplemental~~by ~~rebate.~~third-party ~~Some~~payers, ~~States~~such ~~have~~as ~~implemented~~government ~~statutes~~and ~~imposing~~private ~~other~~insurance ~~consequences~~plans. ~~for~~Third-party apayers ~~manufacturer’s~~are ~~failure~~increasingly inchallenging ~~certain~~the ~~circumstances~~pricing toof ~~negotiate~~products ~~supplemental~~and ~~rebates~~services and implementing other cost containment mechanisms, including ~~but~~demanding ~~not~~more ~~limited~~aggressive topricing ~~ordering~~and ~~managed~~rebates ~~care~~for ~~plans~~favorable toformulary ~~limit~~placement. orThis ~~reduce~~is ~~reimbursement~~especially ~~for~~true ain ~~drug~~markets ~~provided~~where bygeneric options exist. Third-party payers often use a ~~medical~~tiered ~~practitioner~~reimbursement system and may require step edits or prior authorization. IfIt ~~our~~is ~~products~~time ~~are~~consuming ~~not~~and ~~included~~expensive onfor ~~these~~us ~~preferred~~to ~~drug~~seek ~~lists,~~and ~~they~~maintain ~~may~~coverage befor ~~subject~~our products and to ~~prior~~process ~~authorization~~reimbursements from Medicaid, Medicare and private payers.

~~Similarly,~~Participation in ~~order~~the toMedicaid ~~ensure~~program ~~coverage~~requires bypayment ~~Medicare~~of ~~Part~~statutory Drebates ~~and~~on ~~commercial~~unit ~~pharmacy~~dispenses. ~~benefit~~Some ~~plans,~~states wehave ~~participate~~also increated ~~certain~~Medicaid ~~rebate~~preferred ~~programs,~~drug ~~which~~lists ~~provide~~and ~~discounted~~include ~~prescriptions~~drugs toon ~~qualified~~those ~~insured~~lists ~~patients. Under~~only ~~these~~when ~~rebate~~the ~~programs,~~manufacturers weagree to pay a ~~rebate~~supplemental ~~to the third-party administrator of the program~~rebate. WeSome ~~also~~States ~~provide~~have ~~discounts~~implemented tostatutes ~~authorized~~imposing ~~users~~other ofconsequences ~~the~~for ~~Federal~~a ~~Supply~~manufacturer’s ~~Schedule~~failure ~~(“FSS”)~~in ofcertain ~~the~~circumstances ~~General~~to ~~Services~~negotiate ~~Administration~~supplemental ~~under an FSS contract negotiated by the Department of Veterans Affairs~~rebates, including ~~discounts~~but ~~mandated~~not bylimited ~~the Veterans Health Care Act, discounted prescriptions~~ to ~~DoD’s Tricare retail pharmacy program~~, ~~and~~ordering ~~discounts~~managed tocare ~~federal~~plans ~~grantees and safety net providers referred~~ to aslimit ~~covered~~or ~~entities~~reduce ~~pursuant~~reimbursement tofor ~~our~~a ~~pharmaceutical pricing agreement with the Department of Health and Human Services and the 340B~~ drug ~~discount~~provided ~~program,~~by ~~which is required as~~ a ~~condition~~medical ~~of Medicaid coverage~~practitioner. ~~Government~~If ~~agencies~~our ~~ordering under the FSS and covered entities purchase~~ products ~~from~~are ~~the~~not ~~wholesale~~included ~~distributors~~on atthese ~~the~~preferred ~~discounted~~drug ~~price~~lists, ~~and~~they ~~the~~may ~~wholesale~~be ~~distributors~~subject ~~then~~to ~~charge~~prior ~~back the difference between the current wholesale acquisition cost and the price the entity paid for the product~~authorization.

WeSimilarly, ~~also~~in ~~offer~~order ~~co-pay~~to ~~assistance~~ensure coverage by Medicare Part D and commercial pharmacy benefit plans, we participate in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under ~~for~~these ~~our~~rebate ~~proprietary~~programs, ~~products~~we pay a rebate to the third-party administrator of the program. We also provide discounts to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under ~~which~~an ~~patients~~FSS ~~covered~~contract negotiated by ~~commercial~~the ~~pharmacy~~Department ~~benefit~~of ~~plans~~Veterans ~~receive~~Affairs, including discounts onmandated ~~their~~by the Veterans Health Care Act, discounted prescriptions. ~~Our~~to ~~XYOSTED®~~Department ~~STEADYCare~~of ~~Co-pay~~Defense’s ~~Assistance~~(“DoD”) ~~Program provides financial~~Tricare ~~support~~retail pharmacy program, and statutory discounts to ~~most~~federal ~~commercially~~grantees ~~insured~~and ~~patients~~safety net providers referred to ~~assist~~as covered entities pursuant to our pharmaceutical pricing agreement with ~~out-of-pocket~~the ~~costs~~Department of ~~XYOSTED®.~~Health Inand ~~addition~~Human Services and the 340B drug discount program, ~~certain~~which ~~commercially~~is ~~insured~~required ~~patients~~as ~~are~~a ~~eligible~~condition ~~for~~of ~~our~~Medicaid ~~“first~~coverage. ~~fill~~Government ~~free”~~agencies ~~program~~ordering ~~for~~under ~~XYOSTED®~~the toFSS ~~assist~~and covered 340B entities purchase products from the ~~patient~~wholesale ~~during~~distributors at the ~~initial~~discounted ~~claims~~price, ~~adjudication~~and ~~process.~~the Wewholesale ~~utilize~~distributors ~~contract~~then ~~service~~charge ~~providers~~back tothe ~~process~~difference between the current wholesale acquisition cost and ~~pay~~the ~~claims~~price tothe ~~patients~~entity paid for ~~actual~~the ~~usage~~product.

We also offer co-pay assistance programs to patients for our proprietary products under which patients covered by commercial pharmacy benefit plans receive discounts on their prescriptions. Our XYOSTED® STEADYCare Co-pay Assistance Program provides financial support to most commercially insured patients to assist with out-of-pocket costs of XYOSTED®. In addition, certain commercially insured patients are eligible for our “first fill free” program for XYOSTED® to assist the patient during the initial claims adjudication process. Similar to XYOSTED®, we offer a co-pay assistance program for NOCDURNA®, which also provides financial support to most commercially insured patients to assist with out-of-pocket costs. We use contract service providers to process and pay claims to patients for actual usage. We also offer the ability for patients who do not have insurance, or whose insurance does not cover our proprietary products, the ability to purchase either XYOSTED® or NOCDURNA® with a valid prescription at a cash price via a specialty pharmacy.

International Distribution – We are contracting with a third-party logistics provider, Cardinal, for key services related to logistics, warehousing and inventory management, international shipping, export and customs administration to support our international distributor, Lunatus. We entered into an exclusive distribution agreement with Lunatus in August 2020 to distribute and promote the sale of XYOSTED® in Saudi Arabia and the United Arab Emirates. Lunatus is responsible for obtaining regulatory approval and, assuming approval, for the promotion and commercialization of the product in the territories.

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Sales, Marketing & Distribution of Partnered Products

Our partnered products may encounter some of the same reimbursement issues described above, and although we do not control the reimbursement rate or discounts contracted with third-party payers by our partners, it ultimately affects our royalty payments we receive on net sales. The industry has experienced an increasingly widening gap between gross sales and net sales after discounts.

Epinephrine Injection USP – We are the exclusive supplier of the device used in Teva’s epinephrine injection product. We receive payment for each device sold to Teva and royalties on Teva’s commercial sales of the product. Teva’s epinephrine injection was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to Viatris Inc.’s branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, is substitutable at the pharmacy. Teva is solely responsible for commercialization and distribution of the finished product.

Makena® Subcutaneous ~~subcutaneous~~Auto ~~auto injector~~ Injector – ~~Pursuant~~We toare ~~our~~the exclusive ~~license,~~supplier ~~development~~of ~~and supply agreements with AMAG, AMAG is responsible for~~ the ~~commercialization~~device ~~and~~used ~~distribution~~in of the Makena® subcutaneous auto injector. ~~AMAG~~We ~~supplies~~receive ~~the~~payment ~~pre-filled~~for ~~syringe~~each ~~of the drug to Antares, and Antares manufactures the~~ device ~~and oversees the assembly and packaging of the final product, which is~~ sold to ~~AMAG~~Covis ~~at cost plus margin. Antares is entitled to receive high single digit to low double-digit~~ and royalties on ~~net~~Covis’ commercial sales of the ~~Makena® subcutaneous auto injector as well as sales-based milestones~~product. ~~AMAG~~Covis primarily sells Makena® to specialty pharmacies, specialty distributors, home infusion companies and pharmacies which, in turn, sell Makena® to healthcare providers, hospitals, government agencies and integrated delivery systems. Covis is solely responsible for commercialization and distribution of the finished product.

Sumatriptan Injection USP – ~~Under~~We aare ~~license,~~the ~~supply~~exclusive ~~and~~supplier ~~distribution~~of ~~agreement with Teva for~~ the ~~auto injector~~ product containing sumatriptan, wewhich ~~manufacture~~is ~~the~~commercialized ~~device~~by ~~and perform final assembly and packaging of the product.~~ Teva ~~manufactures and supplies the drug and distributes the finished combination product in the U~~.~~S. Teva~~ ~~also~~We ~~has an option for distribution rights in other territories. Under the agreement, we received an upfront payment and a milestone payment upon commercial launch and~~ are compensated at cost for shipments of product to Teva. In addition, net profits from sales of the product, after deduction of product sales allowances such as discounts, rebates and chargebacks, are split 50/50 between us and Teva. ~~The~~ ~~term~~Teva ~~of the agreement~~ is ~~seven~~solely ~~years~~responsible ~~from~~for ~~commercial~~commercialization ~~launch,~~and ~~with~~distribution ~~automatic~~of ~~one-year renewals unless terminated by either party after~~ the ~~initial~~finished ~~term~~product.

Teriparatide Injection – We are the exclusive supplier of the pen injection device used in Teva’s Teriparatide Injection product outside the U.S. Teva launched its generic version of Forsteo® in certain territories outside the U.S. in 2020~~, and is awaiting FDA approval of the generic equivalent of Forteo® in the United States~~. We receive payment for each device sold to Teva and royalties on Teva’s commercial sales of the product in the territories. Teva is solely responsible for commercialization and distribution of the finished product.

OTREXUP® (methotrexate) Injection – Pursuant to the Asset Purchase Agreement, license agreement and supply agreement, we are the exclusive supplier of the device used in OTREXUP® beginning in December 2021. We receive payment for each device sold to Otter. Otter is solely responsible for commercialization and distribution of the finished product.

Information about Revenues and Customer Concentrations

For information about revenues and customer concentrations, ~~please~~ see ~~Part II,~~ Item 7, ~~Management’s Discussion and Analysis~~ of ~~Financial~~Part ~~Condition~~II ~~and Results~~ of ~~Operations~~this –Annual ~~Results~~Report ofon ~~Operations~~Form 10-K. Significant customers from which ~~the~~we ~~Company~~derive ~~derived~~ 10% or more of ~~its~~our total revenue in each or any of the years in the three-year period ended December 31, ~~2020~~2021 include: Teva, McKesson, AmerisourceBergen Corporation, Cardinal Health and ~~AMAG~~Covis. For more detailed information, ~~refer~~see to Note 14 – Revenues, Significant Customers and Concentrations of Risk in the Notes to Consolidated Financial Statements included in Item 8 of Part II, ~~Item~~of 8.this Annual Report on Form 10-K.

Collaborative Arrangements and License Agreements

We have entered into significant partnering arrangements and licensing agreements with Teva, ~~AMAG~~Covis, Pfizer, Idorsia and other pharmaceutical partners. The following is a summary of certain agreements.

Teva License, Development and Supply Agreements

In July 2006, we entered into an exclusive ~~License~~license, ~~Development~~development and ~~Supply~~supply Agreement with Teva for an epinephrine auto injector product to be marketed in the U.S. and Canada. Pursuant to the agreement, Teva is obligated to purchase all of its delivery device requirements from us. We received an upfront cash payment and a milestone payment upon FDA product approval. We also receive a negotiated purchase price for each device sold, as well as royalties on Teva’s ~~future~~commercial sales of the product. This agreement has been amended to provide for payment of capital equipment and other ongoing development work that was outside the scope of the original agreement. The agreement will continue until the expiration of the last to expire patent that is filed no later than 12 months after FDA approval. We have multiple patents that have been granted by the United States Patent and Trademark Officer (“USPTO”) that cover this product, the latest of which will expire in 2033. We have and plan to continue to file patent applications covering this product.

In December 2007, we entered into a license, development and supply agreement with Teva under which we developed and will supply a disposable pen injector for two therapeutic products: exenatide and teriparatide. Under the agreement, we received an upfront payment and development milestones, and may receive royalties on future product sales. This agreement has been amended numerous times and provides for payment of capital equipment and other development work that was outside the scope of the original agreement. This agreement will continue until the expiration date of the last to expire patent covering the device or product that is filed no later than 12 months after FDA approval, and will be automatically renewed for successive periods of two years each. Currently the expiration date of the last to expire patent is 2035.20

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In December 2007, we entered into a license, development and supply agreement with Teva under which we developed and will supply a disposable pen injector for two therapeutic products: exenatide and teriparatide. Under the agreement, we received an upfront payment and development milestones, and may receive royalties on future product sales. This agreement has been amended numerous times and provides for payment of capital equipment and other development work that was outside the scope of the original agreement. This agreement will continue until the expiration date of the last to expire patent covering the device or product that is filed no later than 12 months after FDA approval and will be automatically renewed for successive periods of two years each. Currently, the expiration date of the last to expire patent is 2035. On February 25, 2022, Teva notified us that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022.

In November 2012, we entered into a license, supply and distribution agreement with Teva for an auto injector product containing sumatriptan for the treatment of migraines. Under the agreement, we received an upfront payment and a milestone payment upon commercial launch. Teva is responsible for the manufacture and supply of the drug, and we are responsible for the manufacture and supply of the device and assembly and packaging of the finished product. We are compensated at cost for product shipment to Teva and Teva distributes the product in the U.S. Teva also received an option for distribution rights in other territories. In addition, net profits are split 50/50 between us and Teva. The term of the agreement continues seven years from commercial launch, which was in June 2016, with automatic one-year renewals unless terminated sooner by either party in accordance with the terms of the agreement.

~~AMAG~~Covis Agreements

In September 2014, we entered into a development and license agreement with Lumara Health, Inc., which was subsequently acquired by AMAG, which was subsequently acquired by Covis ~~Group~~, to develop and supply an auto injector system for use with Makena®, a progestin drug (hydroxyprogesterone caproate) indicated to reduce the risk of preterm birth. Under the agreement, we granted an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, and received an upfront payment for our license and development activities. We are also entitled to milestone payments upon the achievement of pre-determined amounts of net sales of the product.

~~AMAG~~Covis was responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, and is responsible for the manufacture and supply of the drug to be used in the product, and to market, distribute and sell the product. We are the exclusive supplier of the auto injection system devices for the product and are responsible for the manufacture and supply of the devices and final assembly and packaging of the finished product. Under the arrangement, we ~~will~~ receive payment for each device, and royalties based on ~~AMAG’s~~ net sales of products commencing on product launch in a particular country until the product is no longer developed, marketed, sold or offered for sale in such country. The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of products and decrease after the expiration of licensed patents or where there are generic equivalents to the auto injector product being sold in a particular country.

In March 2018, we entered into a manufacturing agreement with ~~AMAG~~Covis for the exclusive supply of the devices and fully assembled and packaged final finished product of the Makena® subcutaneous auto injector. The term of the agreement is concurrent with the term of the development and license agreement and will continue until such time ~~AMAG~~as ~~halts~~ commercialization of the product is halted. We receive a contracted price per unit on each product manufactured ~~for AMAG~~.

Pfizer Agreement

In August 2018, we entered into a development agreement with Pfizer to jointly develop a combination drug device rescue pen. This rescue pen will ~~utilize~~use the Antares QuickShot® auto injector and an undisclosed Pfizer drug. ~~Pfizer~~In ~~will~~2021, ~~pay~~we uscontinued ~~for~~to ~~design~~work ~~and~~on this development ~~services~~program, and ~~be responsible for obtaining FDA approval of the combination product. We entered into a separate commercial supply agreement with Pfizer pursuant to which~~ we ~~will~~expect ~~provide fully packaged commercial ready finished product~~ to ~~Pfizer~~continue ~~and~~development ~~Pfizer~~of ~~will~~this ~~then be responsible for commercializing the~~ product ~~in the U~~candidate.~~S., pending FDA approval, for which the Company will receive royalties on net sales and other sales-based milestone payments.~~

Idorsia Agreement

In November 2019, we entered into a new global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. A new chemical entity selatogrel is being developed for the treatment of a suspected ~~acute myocardial infarction (~~AMI) in adult patients with a history of AMI. Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus ~~margin~~mark-up. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. Antares will be entitled to receive royalties on net sales of the commercial product.

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Ferring Agreement

In October 2020, we entered into an exclusive license and commercial supply agreement with Ferring for the marketed product NOCDURNA® (desmopressin acetate) in the ~~United States~~U.S., which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the license agreement, the Company paid Ferring an upfront payment of $5.0 million upon execution and ~~will~~paid ~~pay~~ an additional $2.5 million aton ~~one~~October ~~year~~1, ~~from execution~~2021. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on ~~the~~our ~~Company’s~~ net sales of NOCDURNA® in the ~~United States~~U. S.

16Lipocine Agreement

In October 2021, we entered into an exclusive license agreement with Lipocine for the product TLANDO® (testosterone undecanoate) in the U.S., a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO® was granted tentative approval from the FDA in December 2020 and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus for JATENZO® on March 27, 2022. On February 3, 2022, we announced the FDA’s acceptance of our NDA resubmission for TLANDO® with a target action date set for March 28, 2022. We continue to prepare for the launch of TLANDO® in 2022 pending final FDA approval after the expiration of JATENZO®’s exclusivity period. Under the terms of the license agreement, we paid Lipocine an upfront payment of $11.0 million. Lipocine is eligible for additional milestone payments up to $10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO® in the U.S. We will be responsible for the manufacturing and commercialization of TLANDO®.

The license agreement also grants us the option to license and develop LPCN 1111 (TLANDO XR) in the U.S., a potential once daily oral testosterone product containing testosterone tridecanoate in development for the treatment of hypogonadism in adult males. Results of the Phase 2b study for TLANDO XR met its primary endpoints, including identifying the dose expected to be tested in a Phase 3 study. TLANDO XR was well tolerated with no drug-related severe or serious adverse events reported and the target Phase 3 dose also met its primary and secondary endpoints in the Phase 2b study. TLANDO XR is an investigational drug containing tridecanoate and has not been approved by the FDA, nor has the name been approved. If elected, upon exercise of the option, we will be required to pay an additional $4.0 million in license fees in two installments and will be responsible for additional development and commercial milestone payments as well as tiered royalties on net sales of TLANDO XR in the U.S. In addition, we will be responsible for completing the development program including the conduct of a Phase 3 clinical trial and applying for regulatory approval in the U.S.

Otter Agreement

In December 2021, we entered into an Asset Purchase Agreement with Otter to sell certain worldwide assets used in the operation of the OTREXUP® product line for $44.0 million, subject to finalization of changes in closing inventory to be transferred, and a license agreement for rights to commercialize OTREXUP®. Simultaneously, we entered into a supply agreement with Otter to manufacture the VIBEX® auto-injection system device, designed and developed to incorporate a pre-filled syringe for delivery of methotrexate, assemble, package, label and supply the final OTREXUP® product and related samples to Otter at cost plus mark-up. Otter is responsible for manufacturing, formulation and testing of methotrexate and the corresponding pre-filled syringe for assembly with the device manufactured by us, along with the commercialization and distribution of OTREXUP®.

Seasonality of Business

Certain parts of our business may be affected by seasonality. ~~Our~~Customer revenues may be influenced by many factors, including regulatory and reimbursement approvals, timing of product launches, acquisitions or divestitures, holiday schedules, and other macro-economic conditions. While our revenues do not reflect any significant degree of seasonality, customer purchases have historically been lower in the first quarter of the year due to the resetting of high-deductible health insurance plans. Seasonality ~~may~~affects ~~affect a~~ quarterly ~~comparison~~comparisons within any fiscal year; however, we believe this impact is generally not material to our annual consolidated results. Our revenues may be influenced by many factors, including regulatory and reimbursement approvals, timing of product launches, acquisitions or divestitures, holiday schedules, and other macro-economic conditions.

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Competition

The pharmaceutical, and medical device ~~and biotechnology~~ industries are intensely competitive and subject to rapid and significant technological change. We have a wide range of competitors depending upon the branded or generic marketplace, the therapeutic product category, and the product type, including dosage strengths and route of administration. Our competitors include established ~~biotechnology development companies,~~ specialty pharmaceutical companies, major brand name and generic manufacturers of pharmaceuticals such as Teva, Viatris, Eli Lilly and Endo, as well as a wide range of medical device companies that sell a single or limited number of competitive products or participate in only a specific market segment. Our competitors also include third party contract medical device design and development companies such as Scandinavian Health Ltd., Ypsomed AG, West Pharmaceutical and Owen Mumford Ltd. Many of our competitors have greater financial and other resources than we have, such as more commercial resources, larger research and development staffs and more extensive marketing and manufacturing organizations. Smaller or early stage emerging companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

~~Competition~~If incompetitors ~~the~~introduce ~~injectable~~new ~~drug~~products, delivery ~~market~~systems isor ~~intensifying.~~processes Wewith ~~face~~therapeutic ~~competition~~or ~~from~~cost ~~traditional~~advantages, ~~needles~~our ~~and~~products ~~syringes~~can asbe ~~well~~subject asto ~~newer~~progressive ~~pen-like~~price ~~and~~reductions ~~sheathed~~or ~~needle~~decreased ~~syringes~~volume ~~and~~of ~~other~~sales, ~~injection~~or ~~systems~~both. asBranded ~~well~~products asnot ~~alternative~~only ~~drug~~face ~~delivery~~competition ~~methods~~from ~~including~~other ~~oral~~brands, ~~transdermal~~but ~~and~~also ~~pulmonary~~from ~~delivery~~generic ~~systems~~versions. ~~Nevertheless,~~Generic ~~the~~versions ~~majority~~are ofgenerally ~~injections~~significantly ~~are~~less ~~still~~expensive ~~currently~~than ~~administered~~branded ~~using~~versions, ~~needles.~~and, ~~Because~~where ~~injections~~available, ~~are~~may ~~typically~~be ~~only~~required ~~used~~in ~~when~~preference ~~other~~to ~~drug~~the ~~delivery~~branded ~~methods~~version ~~are~~under ~~not~~third-party ~~feasible~~reimbursement programs, ~~the~~or ~~auto~~substituted ~~injector~~by ~~systems~~pharmacies. ~~may~~Most benew ~~made~~products ~~obsolete~~that bywe introduce must compete with other products already on the ~~development~~market or ~~introduction~~products ofthat ~~drugs~~are orlater ~~drug~~developed ~~delivery~~by ~~methods~~competitors. ~~which~~Manufacturers doof ~~not~~generic ~~require~~pharmaceuticals ~~injection~~typically ~~for~~invest ~~the~~far ~~treatment~~less ofin ~~conditions~~research weand ~~have~~development ~~currently~~than ~~targeted.~~research-based Inpharmaceutical ~~addition,~~companies ~~because~~and wetherefore ~~intend~~can ~~to,~~price attheir ~~least~~products insignificantly ~~part~~lower than branded products. Accordingly, ~~enter~~when ~~into~~a ~~collaborative~~branded ~~arrangements~~product ~~with~~loses ~~pharmaceutical~~its ~~companies~~market exclusivity, ~~our~~it ~~competitive~~normally ~~position~~faces ~~will~~intense ~~depend~~price ~~upon~~competition ~~the~~from ~~competitive~~generic ~~position~~forms of the ~~pharmaceutical~~product. ~~company~~To successfully compete for business with ~~which~~managed care and pharmacy benefit management organizations, we ~~collaborate~~must ~~for~~often ~~each~~demonstrate ~~drug~~that ~~application~~our products offer not only medical benefits but also cost advantages as compared with other forms of care.

If competitors introduce new products, delivery systems or processes with therapeutic or cost advantages, our products can be subject to progressive price reductions or decreased volume of sales, or both. Branded products not only face competition from other brands, but also from generic versions. Generic versions are generally significantly less expensive than branded versions, and, where available, may be required in preference to the branded version under third-party reimbursement programs, or substituted by pharmacies. Most new products that we introduce must compete with other products already on the market or products that are later developed by competitors. Manufacturers of generic pharmaceuticals typically invest far less in research and development than research-based pharmaceutical companies and therefore can price their products significantly lower than branded products. Accordingly, when a branded product loses its market exclusivity, it normally faces intense price competition from generic forms of the product. To successfully compete for business with managed care and pharmacy benefits management organizations, we must often demonstrate that our products offer not only medical benefits but also cost advantages as compared with other forms of care.

Newly introduced generic products with limited or no other generic competition typically command higher prices initially. At the expiration of the exclusivity period, other generic distributors may enter the market, resulting in a significant price decline for the drug. As a result, the maintenance of profitable operations in generic pharmaceuticals depends, in part, on our ability to select, develop and launch new generic products in a timely and cost-efficient manner and to maintain efficient, high quality manufacturing capabilities.

Industry Trends

Based upon our experience, we believe the following significant trends have important implications for the growth of our business. Recent trends in the pharmaceutical industry include merger and acquisition activity leading to further market consolidation. In many cases, the resulting combined pharmaceutical companies are bigger and have more financial, technical and market strength and greater resources, which increases competitive pressure in the industry.

There is ongoing effort by public and private payers to reduce the cost of drugs and reduce the overall cost of health care. There continues to be greater pressure on drug manufacturers to provide greater discounts and rebates on their products. The drug distribution channels are complex and involve many different parties. Recently, such channels have undergone and continue to undergo consolidation. Drug wholesalers and retail drug chains have merged or consolidated resulting in significantly larger organizations with greater resources and bargaining power controlling multiple levels of the drug distribution network. Consequently, pharmaceutical companies are facing increasing pressure to reduce prices. Additionally, the emergence of large buying groups representing independent retail pharmacies and other drug distributors, and the prevalence and influence of managed care organizations and similar institutions, enable those groups to demand larger price discounts on our products. Large wholesalers and retailer customers have continued to form partnerships. As a result of this consolidation among wholesale distributors as well as the growth of large retail drug store chains, a small number of large wholesale distributors control a significant share of the market.

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~~organizations~~Table ~~with greater resources and bargaining power controlling multiple levels~~ of the drug distribution network. Consequently, pharmaceutical companies are facing increasing pressure to reduce prices. Additionally, the emergence of large buying groups representing independent retail pharmacies and other drug distributors, and the prevalence and influence of managed care organizations and similar institutions, enable those groups to demand larger price discounts on our products. Large wholesalers and retailer customers have continued to form partnerships, such as the alliance between CVS and Cardinal Health. As a result of this consolidation among wholesale distributors as well as the growth of large retail drug store chains, a small number of large wholesale distributors control a significant share of the market. Contents

Government Regulation

Any potential products discovered, developed and manufactured by us or our collaborative partners must comply with comprehensive regulation by the FDA in the U.S. and by comparable authorities in other countries. These national agencies and other federal, state, and local entities regulate, among other things, the pre-clinical and clinical testing, safety, effectiveness, approval, manufacturing operations, quality, labeling, distribution, controlled substance security, export, import, storage, record keeping, safety and other reporting, sampling, advertising, marketing, and promotion of pharmaceutical products and medical devices. Facilities and certain company records are also subject to inspections by the FDA and comparable authorities or their representatives.

The FDA has broad discretion in enforcing the Federal Food, Drug and Cosmetic Act (“FFDCA”) and the regulations thereunder, and noncompliance can result in a variety of regulatory enforcement actions ranging from warning letters, product detentions, device alerts or field corrections to recalls, seizures, manufacturing shut downs, quarantines, refusal of the government to approve NDAs or ANDAs, or supplements to the same, clinical holds, injunctive actions, withdrawal of approvals, civil or criminal actions or penalties, disgorgement, adverse publicity, labeling revisions, dear healthcare provider letters, FDA debarment, exclusion from Federal healthcare programs, contract debarment or refusal of future orders under existing government contracts, consent decrees, and corporate integrity agreements. Furthermore, new government requirements may be established that could delay or prevent regulatory approval of our products under development.

Drug Approval Process

FDA approval of our own and our partners’ products is required before the products may be commercialized in the U.S. Section 505 of the FFDCA describes three regulatory pathways for marketing authorization for a new drug:

• A 505(b)(1) NDA is an application that is used for the approval of a new drug that contains full reports of investigations of safety and effectiveness.

• A 505(b)(2) NDA is an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This alternate route for regulatory approval permits the applicant to rely in part upon the FDA’s findings of safety and effectiveness for previously approved products and/or published scientific literature.

• Section 505(j) establishes an abbreviated approval process for generic versions of approved drug products through the submission of an ANDA. An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths, route of administration, and dosage form as the listed drug, which has the same labeling, performance, characteristics, and intended use as the listed drug, and has been shown to be bioequivalent to the listed drug. ANDA applicants are generally required to conduct bioequivalence testing to confirm pharmaceutical and therapeutic equivalence to the branded reference drug. Generic versions of drugs can often be substituted by pharmacists under prescriptions written for the branded reference drug, pursuant to state laws.

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For both NDAs and ANDAs, the FDA reviews applications to determine, among other things, whether a product is safe and effective for its intended use and whether the manufacturing methods and controls are adequate to assure and preserve the product’s identity, strength, quality, safety, potency, and purity. The following table provides a summary description of the various regulatory pathways:

~~ANDA~~

ANDA

~~505(b)(2) NDA~~

~~505(b)(1) NDA~~

505(b)(2) NDA

505(b)(1) NDA

Clinical Trials/Testing Required

~~Generally, bioequivalence.~~

Generally, bioequivalence.

~~Yes, to address potential differences between the branded reference product and the 505(b)(2) product, as well as bridging studies.~~

~~Yes, full reports of safety and efficacy.~~

Yes, to address potential differences between the branded reference product and the 505(b)(2) product, as well as bridging studies.

Yes, full reports of safety and efficacy.

Results in Orange Book Listed Patents

~~Yes, for novel formulations, other enhancements and new indications.~~

~~Yes~~

Yes, for novel formulations, other enhancements and new indications.

Yes

Exclusivity

~~Potential for 180 days against other generic filers if first generic to file a substantially complete application containing a paragraph IV certification that is lawfully maintained.~~

Potential for 180 days against other generic filers if first generic to file a substantially complete application containing a paragraph IV certification that is lawfully maintained.

Potential for 30-month stay if ANDA or 505(b)(2) applicant citing our or our partners’ product as a reference listed drug includes a paragraph IV certification. Also potential for three or five year exclusivity, like 505(b)(1) NDAs.

Potential for five years for a new chemical entity, or three years for new clinical investigations (other than bioavailability and bioequivalence studies) that are essential to approval of the application. Potential for 30-month stay if ANDA or 505(b)(2) applicant citing our or our partners’ product as a reference listed drug includes a paragraph IV certification.

Potential for 30-month stay if ANDA or 505(b)(2) applicant citing our or our partners’ product as a reference listed drug includes a paragraph IV certification. Also, potential for three- or five-year exclusivity, like 505(b)(1) NDAs.

Potential of five years for a new chemical entity, or three years for new clinical investigations (other than bioavailability and bioequivalence studies) that are essential to approval of the application. Potential for 30-month stay if ANDA or 505(b)(2) applicant citing our or our partners’ product as a reference listed drug includes a paragraph IV certification.

Patent Certification Required

~~Yes~~

Yes

~~Yes~~

Yes

Potential orphan drug designation Drug Status

Yes

Potential Orphan Drug Designation Drug Status

Yes

NDA Submission

The process required by the FDA before a new drug pharmaceutical product or a change to an already approved pharmaceutical product, may be approved for marketing in the U.S. generally involves:

• pre-clinical laboratory and animal tests;

• submission to the FDA of an Investigational New Drug (“IND”) application, which must be in effect before clinical trials may begin;

• adequate and well controlled human clinical trials to establish the safety and efficacy of the drug for its intended indication(s);

• development of manufacturing processes to ensure the drug’s identity, strength, quality, and purity;

• submission to the FDA of aan NDA;

• FDA compliance inspections and/or clearance of all manufacturers and facilities, as well as select clinical trial sites; and

• FDA review of the NDA in order to determine, among other things, whether the drug is safe and effective for its intended uses.

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The preclinical and clinical testing and approval process takes many years and the actual time required to obtain approval, if any, may vary substantially based upon the type, complexity and novelty of the product or disease. Preclinical tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal studies to assess the characteristics and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including cGLPs. The results of preclinical testing are submitted to the FDA as part of an IND, to support human clinical trials along with other information, including information about product chemistry, manufacturing and controls, available scientific literature, and a proposed clinical trial protocol. Some preclinical testing may continue even after the IND is submitted. In the case of drug product candidates for which the sponsor will seek marketing approval via a 505(b)(2) NDA application, some of the above information may be abbreviated or omitted.

19IND applications automatically become effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold. If the FDA places a trial on clinical hold, the sponsor must address the issue to the FDA’s satisfaction before the trial may begin. In addition, an independent Institutional Review Board (“IRB”) must review, approve and monitor the plan for any clinical trial, subject communications, and informed consent information for subjects before the trial commences. The FDA, the IRB or the sponsor may suspend a clinical trial, place a trial on hold or discontinue a trial at any time on various grounds.

IND applications automatically become effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold. If the FDA places a trial on clinical hold, the sponsor must address the issue to the FDA’s satisfaction before the trial may begin. In addition, an independent Institutional Review Board (“IRB”) must review, approve, and monitor the plan for any clinical trial, subject communications, and informed consent information for subjects before the trial commences. The FDA, the IRB, or the sponsor may suspend a clinical trial, place a trial on hold, or discontinue a trial at any time on various grounds.

Once an IND is in effect, each new clinical protocol and any amendments to the protocols must be submitted to the IND for FDA review, and to the IRB for approval. Progress reports detailing the results of the clinical trials must also be submitted at least annually to the FDA and the IRB and more frequently if serious adverse events or other significant safety information is found.

Sponsors of clinical trials generally must register and report, at the NIH-maintained website ClinicalTrials.gov, key parameters of certain clinical trials, including clinical trial results within set timeframes, with the exception of PK studies. Failure to submit the required information to ClinicalTrials.gov can result in monetary penalties. Investigators must also provide certain information to the clinical trial sponsors to enable sponsors to make certain financial disclosures to the FDA. Moreover, under the 21st Century Cures Act, manufacturers or distributors of investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must have a publicly available policy concerning expanded access to investigational drugs.

Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients in accordance with the applicable protocol and all applicable laws, rules and regulations. Clinical trials are typically conducted in sequential phases, which may overlap, though in the case of a 505(b)(2) NDA, some study requirements may be abbreviated. Studies, in addition to the below, such as pediatric studies, may also be required by the FDA:

• Phase I -– During ~~phase~~Phase I, when the drug is initially given to human subjects, the product is tested for safety, dosage tolerance, absorption, distribution, metabolism and excretion. Phase I studies are often conducted with healthy volunteers depending on the drug being tested. If possible, Phase I trials may also be used to gain an initial indication of product effectiveness.

• Phase II -– Phase II involves controlled studies in a limited patient population, typically patients with the conditions needing treatment, to evaluate preliminarily the efficacy of the product for specific, targeted indications; determine dosage tolerance and optimal dosage; and identify possible adverse effects and safety risks.

• Pivotal or Phase III -– Adequate and well-controlled trials are undertaken in ~~phase~~Phase III in order to evaluate efficacy and safety in a comprehensive fashion within an expanded patient population for seeking approval of the new drug. Typically, two Phase III trials are required by FDA for product approval.

In the case of 505(b)(2) NDAs, the above studies may be abbreviated. Following marketing approval, sponsors may also voluntarily or be required to conduct additional studies, called Phase IV studies.

In some cases, FDA programs may be available to expedite or simplify the process of drug development and FDA marketing application review. For instance, drug products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means the FDA may approve the product based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. A drug candidate approved on this basis is subject to FDA’s prior review of promotional materials. Accelerated approval products are also required to conduct rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug or biologic from the market on an expedited basis. If FDA proposes withdrawing an accelerated approval, the agency provides the applicant with an opportunity for a hearing. If the applicant files a timely request for a hearing, the applicant must submit any data and information to FDA upon which it plans to rely. At the hearing, an advisory committee is asked to review the applicable issues and provide advice and recommendations to FDA.26

InTable ~~addition, under the Pediatric Research Equity Act, or PREA, a NDA or supplement to a NDA for a new active ingredient, indication, dosage form, dosage regimen, or route~~ of administration must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.Contents

~~The~~In ~~results~~some cases, FDA programs may be available to expedite or simplify the process of drug development and FDA marketing application review. For instance, ~~pre~~drug products studied for their safety and effectiveness in treating serious or life-~~clinical~~threatening ~~studies~~illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means the FDA may approve the product based upon a surrogate endpoint that is reasonably likely to predict clinical ~~trials~~benefit, ~~are~~or ~~submitted~~on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. A drug candidate approved on this basis is subject to the FDA’s asprior ~~part~~review of apromotional ~~NDA~~materials. Accelerated ~~NDAs~~approval products are also ~~must~~required ~~contain~~to ~~extensive~~conduct ~~chemistry~~rigorous post-marketing compliance requirements, ~~manufacturing~~including ~~and~~the ~~control~~completion ~~information~~of Phase IV or post-approval clinical trials to confirm the effect on the clinical endpoint. InFailure ~~most~~to ~~cases~~conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the ~~submission~~FDA ofto withdraw the drug or biologic from the market on an expedited basis. If the FDA proposes withdrawing an accelerated approval, the agency provides the applicant with an opportunity for a ~~NDA~~hearing. If isthe ~~subject~~applicant tofiles a ~~substantial~~timely ~~application~~request ~~user~~for ~~fee~~a hearing, the applicant must submit any data and information to the FDA upon which it plans to rely. At ~~Fee~~the ~~waivers~~hearing, oran ~~reductions~~advisory ~~are~~committee ~~available~~is inasked ~~certain~~to ~~circumstances~~review the applicable issues and provide advice and recommendations to the FDA.

20Sponsors may also request that a product be designated under the FDA’s fast track program. Under this program, products that are intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need, if so designated by the FDA, are eligible for more frequent development meetings and correspondence with the FDA. In addition, the FDA may initiate review of sections of an application before the application is complete. This “rolling review” is available if the applicant provides and the FDA approves a schedule for the remaining information. In some cases, a fast-track product may be eligible for other FDA programs intended to expedite product development and approval for serious and life-threatening diseases. Notably, however, such designations and programs may be withdrawn by the FDA and such designations and programs do not guarantee that a product will ultimately be successfully developed or approved for marketing.

~~Once~~Another ~~the~~program ~~FDA~~that ~~receives~~is anintended ~~application,~~to itfacilitate ~~has~~development 60is ~~days to review~~ the ~~NDA~~special toprotocol ~~determine~~assessment if(“SPA”) itprogram. isUnder ~~substantially~~this ~~complete~~program, ~~to permit~~ a ~~substantive~~sponsor ~~review~~may ~~and will~~ be ~~accepted~~able ~~for~~to ~~filing. The FDA may~~ request ~~additional information rather than accept~~ a ~~NDA~~special ~~for~~protocol ~~filing.~~assessment, ~~Once~~or ~~the~~SPA ~~submission~~to isreach ~~accepted~~agreement ~~for~~with ~~filing,~~ the FDA’s ~~goal~~on iscertain tostudies. ~~review~~If ~~90%~~a ofwritten ~~all~~agreement ~~applications~~is ~~for~~reached ~~non-New~~regarding ~~Molecular Entities (“NMEs”), within ten months from~~ the ~~submission~~applicable ~~date.~~study ~~For NMEs~~protocol, ~~FDA has~~ the ~~goal~~agreement ofwill ~~completing~~be ~~its~~binding ~~review~~on ofthe ~~90%~~FDA ofand ~~applications within ten months of~~ the ~~60-day~~protocol ~~filing date. The FDA, however,~~ may ~~give~~not abe ~~priority~~changed ~~review~~by ~~designation~~the tosponsor ~~drugs~~or ~~that~~the ~~are~~FDA ~~intended~~after tothe ~~treat~~trial ~~serious~~begins ~~conditions~~except ~~and,~~with ifthe ~~approved,~~written ~~would~~agreement ~~provide~~of ~~significant improvements in~~ the ~~safety~~sponsor orand ~~effectiveness of~~ the ~~treatment,~~FDA ~~diagnosis,~~ or ~~prevention~~if of the ~~serious~~FDA ~~conditions.~~determines ~~A priority review means~~ that ~~the~~a ~~goal~~substantial ~~for~~scientific ~~the~~issue ~~FDA~~essential is to ~~review~~determining anthe ~~application~~safety ~~within~~or ~~six~~efficacy ~~months~~ of the ~~submission~~product ~~date~~candidate ~~for~~was ~~non-NMEs~~identified ~~and~~after ~~within six months of~~ the ~~60-day~~testing ~~filing~~began. ~~date~~An ~~for~~SPA ~~NMEs.~~is ~~These~~not ~~timeframes,~~binding ~~however,~~if ~~are~~new ~~only~~circumstances ~~goals~~arise, ~~which~~and ~~FDA~~there ~~may~~is ~~not~~no ~~meet. Moreover,~~guarantee ~~the~~that ~~review~~a ~~process~~study ~~may~~will ~~also~~support bean ~~extended~~approval even if the ~~FDA~~study ~~requests~~is orsubject ~~the~~to ~~NDA~~an ~~sponsor otherwise provides substantial additional information or clarification regarding the submission~~SPA.

In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA for a new active ingredient, indication, dosage form, dosage regimen, or route of administration must contain data that is adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements.

The results of drug development, pre-clinical studies and clinical trials are submitted to the FDA as part of an NDA. NDAs also must contain extensive chemistry, manufacturing and control information. In most cases, the submission of an NDA is subject to a substantial application user fee. Fee waivers or reductions are available in certain circumstances.

Once the FDA receives an application, it has 60 days to review the NDA to determine if it is substantially complete to permit a substantive review and will be accepted for filing. The FDA may request additional information rather than accept an NDA for filing. Once the submission is accepted for filing, the FDA’s goal is to review 90% of all applications for non-New Molecular Entities (“NMEs”) within ten months from the submission date. For NMEs, the FDA has the goal of completing its review of 90% of applications within ten months of the 60-day filing date. The FDA, however, may give a priority review designation to drugs that are intended to treat serious conditions and, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of the serious conditions. A priority review means that the goal for the FDA is to review an application within six months of the submission date for non-NMEs and within six months of the 60-day filing date for NMEs. These timeframes, however, are only goals, which the FDA may not meet. Moreover, the review process may also be extended if the FDA requests or the NDA sponsor otherwise provides substantial additional information or clarification regarding the submission.

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The FDA may also choose or be required to refer drugs to advisory committees when it is determined that an advisory committee’s expertise would be beneficial to the regulatory decision-making process, including the evaluation of new technology. An advisory committee is a panel that includes clinicians and other experts, which review, evaluate, and make a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

After evaluating the NDA and all related information, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter authorizing marketing for specific conditions, or, in some cases, a Complete Response Letter (“CRL”) describing the application deficiencies. If a CRL is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter; withdraw the application; or request an opportunity for a hearing. The FDA has the goal of reviewing 90% of application resubmissions in either two or six months of the resubmission date, depending on the kind of resubmission.

If a product meets the FDA’s approval standards but the approval of the product cannot be made effective before the expiration of patents or exclusivities held by the reference listed drug, the FDA may issue a tentative approval letter to the applicant. Under these circumstances, the FDA delays the final approval of the product until all patent or exclusivity issues have been resolved. Products with tentative approvals may not be marketed until the FDA issues a final approval. Following a tentative approval, applicants may amend their application; however, amendments may delay the FDA’s ability to finalize the approval as the FDA must review and approve the amendment. In order to obtain final approval, the applicant must submit a request to the FDA for final approval (which we did for TLANDO® on January 28, 2022 with acceptance by the FDA announced on February 3, 2022). The FDA’s review of requests for final approval may take a number of months and depends on the content of the request and the kind of application. Even if a product has received tentative approval, there is no guarantee that the product will receive final approval, as new information may emerge that changes the FDA’s prior determination.

ANDA Submissions

A pharmaceutical company seeking to market a generic version of a branded drug must file aan ANDA with the FDA. For ANDAs, applicants are not required to conduct complete clinical studies. Such applications, though, normally require bioavailability and/or bioequivalence studies, conducted in accordance with Good Clinical Practices (“GCPs”) and under the supervision of an IRB.

Like NDAs, ANDAs must be accompanied by user fees. For generic drugs, other fees, such as fees for drug master files, program fees and fees for manufacturing facilities, ~~also~~ may also be required to be paid by the applicant, manufacturer, and/or drug master file holder.

Following submission of an ANDA, the FDA has 60 days to evaluate the application to determine if it is substantially complete. If the agency finds that the application is substantially complete, it will receive the application and begin its substantive review. As part of this substantive review, the FDA will determine whether or not the generic version submitted by the company meets the necessary approval standards, including bioequivalence to the reference listed drug, adequate chemistry, manufacturing, and controls, and manufacturing facilities and clinical study sites passing pre-approval inspections. Under the FDA’s Generic Drug User Fee Act performance goals, the FDA has the goal of reviewing and acting on 90% of standard original ANDAs within ten months of submission.; ~~However~~however, certain factors can lengthen or shorten this review timeline.

Following its completion of the review of aan ANDA, the FDA will either issue an approval letter, authorizing marketing for specific conditions, or a CRL. If a CRL is issued, the applicant may either respond to the FDA, addressing all of the deficiencies identified in the letter;, withdraw the application; or request an opportunity for a hearing. The FDA may also tentatively approve an ANDA application, as described above.

Upon approval, the FDA will rate generic drug products in the Orange Book. Products meeting bioequivalence standards will typically receive an AB rating. Under state law, such generic drug products may be able to be substituted at the pharmacy for the brand-name drug, without the intervention of the prescribing physician, unless otherwise specified by the patient or physician,. Many third -party payers of prescription drugs (e.g., health insurance plans, Medicare and Medicaid programs) have adopted policies to encourage the substitution of the lower-priced AB-rated generic drugs for the higher-priced branded drugs, when an AB-rated generic drug is available, as generic drugs are sold generally at prices below those of the corresponding branded products. Generic drugs may provide a cost-effective alternative for consumers, while maintaining the same active ingredient(s), dosage form, strength, route of administration, and conditions of use as the branded product.

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Generally Applicable Requirements

Clinical trials for all product candidates must be conducted in accordance with GCPs, which include the requirements that all research subjects provide their informed consent in writing for their participation in any clinical trial as well as review and approval of the study by an IRB. Before approving an application, the FDA may inspect one or more clinical trial sites to assure compliance with GCPs.

Further, during development, the manufacture of investigational drugs for the conduct of human clinical trials is subject to cGMP requirements. Investigational drugs and active pharmaceutical ingredients imported into the U.S. are also subject to regulation by the FDA relating to their labeling and distribution. Further, the export of investigational drug products outside of the U.S. is subject to regulatory requirements of the receiving country as well as U.S. export requirements under the FDCA.

For both NDAs and ANDAs, the FDA also may require submission of a risk evaluation and mitigation strategy (“REMS”) to ensure that the benefits of the drug outweigh the risks of the drug. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval. Further, should new safety information arise, additional testing, product labeling, or FDA notification may be required.

The Hatch-Waxman Amendments, Regulatory Exclusivity, and Patent Term Extension

Orange Book Patent Listing

When an NDA is submitted to the FDA seeking approval of a drug, including a 505(b)(2) NDA, the applicant is required to list certain patents whose claims cover the applicant'’s product or method of use with the FDA. Upon approval of aan NDA, each of the patents listed in the application for the drug is then published in the Orange Book. In an effort to clarify which patents must be listed in the Orange Book, in January 2021, Congress passed the Orange Book Transparency Act of 2020, which largely codifies the FDA’s existing practices into the FDCA.

The Orange Book listed NDA products may be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA. Any applicant who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a 505(b)(2) NDA referencing a drug listed in the Orange Book must certify to the FDA that: (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such patent expires and approval will not be sought until after the patent expiration; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. This last certification is known as a paragraph IV patent certification. The applicant may also elect to submit a "“section viii"” statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. Generally, the ANDA or 505(b)(2) NDA approval cannot be made effective by FDA until all listed patents have expired, except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through a paragraph IV certification or if the applicant is not seeking approval of a patented method of use.

If the ANDA or 505(b)(2) applicant makes a paragraph IV certification challenging an Orange Book-listed patent, a notice of the paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA or 505(b)(2) application refers. If the NDA holder or patent owners of the listed drug asserts infringement of the patent in court within 45 days of the receipt of the paragraph IV certification notice, the FDA is prohibited from making the approval of the ANDA or 505(b)(2) application effective until the earlier of 30 months from the receipt of the paragraph IV certification, the expiration of the patent, the settlement of the lawsuit, a decision in the infringement case that is favorable to the applicant, or such shorter or longer period as may be ordered by a court. The ANDA or 505(b)(2) application approval also will not be made effective until any applicable non-patent exclusivity listed in the Orange Book has expired as described in further detail below.

Recently, Congress, the Administration, and administrative agencies have introduced and/or taken certain measures to increase drug competition and thus, decrease drug prices, including with respect to drug importation, making reference product available to facilitate the development and testing of generic and 505(b)(2) products, and shared and individual REMS. New legislative and regulatory efforts could ultimately have an adverse impact on our business and results of operation.

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Non-Patent Exclusivity

The holder of an NDA may be entitled to a period of non-patent exclusivity, during which the FDA cannot make the approval of an ANDA or 505(b)(2) application that relies on the listed drug effective. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon NDA approval of a new chemical entity (“NCE”), during which the FDA cannot accept ~~for filing~~ any ANDA or 505(b)(2) application for filing for the same active moiety except that the FDA may accept an application for filing after four years if the follow-on applicant makes a paragraph IV certification.

The holder of aan NDA, including one approved under Section 505(b)(2), may obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as a new formulation for a previously approved product or a new dosage form or route of administration, if one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential to the approval of the application and was conducted or sponsored by the applicant. Should this occur, the FDA would be precluded from making the approval of any ANDA or 505(b)(2) application effective for the protected modification until after that three-year exclusivity period has ended. However, unlike NCE exclusivity, the FDA can accept an application and begin the review process during the exclusivity period. Five-year and three-year exclusivity will also not delay the submission or approval of a full NDA.

22In addition, an applicant submitting an ANDA to the FDA may be entitled to a 180-day market exclusivity period with respect to subsequently filed generic applications if such applicant is the first to submit a substantially complete application to the FDA and whose filing includes a paragraph IV certification that the applicable patent(s) are invalid, unenforceable and/or not infringed, obtains approval, and launches the product in the marketplace without triggering any statutory forfeiture provisions. An ANDA for a product designated as competitive generic therapy that does not otherwise have patent or exclusivity protections listed in the Orange Book and that is the first approved applicant, is also eligible for a period of 180 days of regulatory exclusivity with respect to other ANDAs. These ANDA exclusivity periods, however, can be lost under certain circumstances. Competitive generic therapies are products for which there is not more than one approved drug included in the Orange Book.

bePediatric ~~precluded~~exclusivity ~~from~~is ~~making~~another type of non‑patent marketing exclusivity in the ~~approval~~U.S. and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any ~~ANDA~~existing orregulatory ~~505(b)(2)~~and ~~application~~statutory ~~effective~~exclusivity for NDA products, including the ~~protected~~non‑patent ~~modification~~exclusivity ~~until~~period ~~after~~described ~~that~~above ~~three-year~~and patent protections. This six‑month exclusivity ~~period~~may ~~has~~be ~~run~~granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. ~~However,~~The ~~unlike~~data ~~NCE~~does ~~exclusivity~~not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s ~~can~~request, ~~accept~~the anadditional ~~application~~protection is granted. If reports of requested pediatric studies are submitted to and ~~begin~~accepted by the ~~review~~FDA ~~process~~within the required time frames, whatever statutory or regulatory periods of exclusivity or Orange Book listed patent protection cover the drug are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve an ANDA or 505(b)(2) application owing to regulatory exclusivity ~~period~~or listed patents. ~~Five~~Moreover, ~~year~~pediatric exclusivity attaches to all formulations, dosage forms, and ~~three-year~~indications for products with existing marketing exclusivity ~~will~~or ~~also~~patent ~~not~~life ~~delay~~that contain the ~~submission~~same oractive ~~approval~~moiety ofas athat ~~full~~which ~~NDA~~was studied.

InIf ~~addition~~approved, andrug ~~applicant~~products ~~submitting~~may analso ~~ANDA~~be toeligible ~~the~~for ~~FDA~~periods ~~may~~of beU.S. ~~entitled~~patent toterm arestoration ~~180~~if ~~day~~the ~~market~~approval ~~exclusivity~~is ~~period~~the ~~with~~first ~~respect~~permitted tocommercial ~~subsequently~~marketing ~~filed~~for ~~generic~~the ~~applications~~product. ifIf ~~such~~granted, ~~applicant~~patent isterm restoration extends the ~~first~~patent tolife ~~submit~~of a ~~substantially~~single ~~complete~~unexpired ~~application~~patent, tothat ~~FDA~~has ~~and~~not ~~whose~~previously ~~filing~~been ~~includes~~extended, for a ~~Paragraph~~maximum IVof ~~certification~~five ~~that~~years. The total patent life of the ~~applicable~~product ~~patent(s)~~with ~~are~~the ~~invalid,~~extension ~~unenforceable~~also ~~and/or~~cannot ~~not~~exceed ~~infringed,~~fourteen ~~obtains~~years from the product’s approval, ~~and~~date. Subject ~~launches~~to the ~~product~~prior inlimitations, the ~~marketplace~~period ~~without~~of ~~triggering~~the ~~any~~extension ~~statutory~~is ~~forfeiture~~calculated ~~provisions.~~by Anadding ~~ANDA~~half ~~for~~of athe ~~product~~time ~~designated~~from asthe ~~competitive~~effective ~~generic~~date ~~therapy~~of ~~that~~an ~~does~~IND ~~not~~to ~~otherwise~~the ~~have~~initial ~~patent~~submission orof ~~exclusivity~~a ~~protections~~marketing ~~listed~~application, inand all of the ~~Orange~~time ~~Book~~between ~~and~~the ~~that~~submission isof the ~~first~~marketing ~~approved~~application ~~applicant,~~and isits ~~also~~approval. This ~~eligible~~period ~~for~~may abe ~~period~~reduced ofby ~~180~~any ~~days~~time ofthat ~~regulatory~~the ~~exclusivity~~applicant ~~with~~did ~~respect~~not toact ~~other~~with ~~ANDAs~~due diligence. Whether ~~These~~any ~~ANDA~~of ~~exclusivity~~our ~~periods,~~product ~~however,~~candidates ~~can~~will be ~~lost~~eligible ~~under~~for ~~certain~~patent ~~circumstances. Competitive~~term ~~generic~~restoration ~~therapies~~is ~~are~~currently ~~products~~unknown. Later, ~~for~~the ~~which~~applicable ~~there~~regulatory isauthorities ~~not~~may ~~more~~determine ~~than~~that ~~one~~we ~~approved~~are ~~drug~~not ~~included~~eligible infor ~~the~~such ~~Orange~~restoration ~~Book~~periods.

Pediatric exclusivity is another type of non‑patent marketing exclusivity in the U.S. and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory and statutory exclusivity for NDA products, including the non‑patent exclusivity period described above and patent protections. This six‑month exclusivity may be granted if a NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the required time frames, whatever statutory or regulatory periods of exclusivity or Orange Book listed patent protection cover the drug are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve an ANDA or 505(b)(2) application owing to regulatory exclusivity or listed patents. Moreover, pediatric exclusivity attaches to all formulations, dosage forms, and indications for products with existing marketing exclusivity or patent life that contain the same active moiety as that which was studied.

If approved, drug products may also be eligible for periods of U.S. patent term restoration if the approval is the first permitted commercial marketing for the product. If granted, patent term restoration extends the patent life of a single unexpired patent, that has not previously been extended, for a maximum of five years. The total patent life of the product with the extension also cannot exceed fourteen years from the product’ approval date. Subject to the prior limitations, the period of the extension is calculated by adding half of the time from the effective date of an IND to the initial submission of a marketing application, and all of the time between the submission of the marketing application and its approval. This period may be reduced by any time that the applicant did not act with due diligence. Whether any of our product candidates will be eligible for patent term restoration is currently unknown. Later, the applicable regulatory authorities may determine that we are not eligible for such restoration periods.

Depending on the drug product, other periods of regulatory exclusivity, such as orphan drug product exclusivity, may also block subsequent applicants.

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Orphan Drug Designation

Some jurisdictions, including the U.S., may designate drugs for relatively small patient populations as orphan drugs. Pursuant to the Orphan Drug Act, the FDA grants orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S. or ~~affecting~~affects more than 200,000 in the U.S. and for which there is no reasonable expectation that the cost of developing and making the product available in the U.S. will be recovered from U.S. sales. Additionally, sponsors must present a plausible hypothesis for clinical superiority to obtain orphan designation if there is a product already approved by the FDA that is intended for the same indication and that is considered by the FDA to be the same as the already approved product. This hypothesis must be demonstrated to obtain orphan exclusivity. Orphan drug designation provides certain benefits, such as the opportunity for grants, tax credits, application user fee waivers, and exemption from program user fees under certain circumstances. The tax advantages, however, were limited in the 2017 Tax Cuts and Jobs Act. If approved for the orphan designation, orphan designated drugs may receive seven years of exclusivity, which, subject to certain exceptions, protects the drug from FDA approval of another drug with the same principal molecular features for the same orphan indication. The FDA may, however, approve a product with the same principal molecular features for the same orphan indication during this time period, if such product is able to demonstrate clinical superiority. The FDA may further approve a product with the same principal molecular features for a different indication, or a different product for the same indication during the orphan exclusivity period. Orphan exclusivity can also be lost under certain circumstances, such as the inability of the application holder to ensure sufficient quantities of the product. Orphan drugs are also exempt from the above discussed PREA requirements. Orphan drugs are not, however, exempt from pediatric testing for molecularly targeted oncology drugs.

Combination Drug/Device Regulation

Our products, and our products marketed by our partners, as well as our products being developed by our partners are most often categorized as “drug-device combination products” because they contain both a drug and a device to administer the drug. To date, our and our partners’ combination products have been regulated as drug, and are therefore subject to the NDA, ANDA, sNDA, sANDA and 505(b)(2) drug approval process and regulations. Combination drug/device products raise unique scientific, technical and regulatory issues. The FDA has established an Office of Combination Products (“OCP”) to address the challenges associated with the review and regulation of combination products. The OCP assists in determining strategies for the approval of drug/delivery device combinations and assuring agreement within the FDA on review responsibilities. The device specific information is filed with the FDA as part of the drug approval submission or it may be filed separately in the form of a device master file, also known as the master access file (“MAF”). A MAF is not an FDA approval submission but is a filing that can be used to provide supporting data for our partners’ drug approval submissions. A MAF will be reviewed by the FDA only when referenced in an approval submission. By filing a MAF, we are able to provide information directly to the FDA, which can then be referenced by our partners in their drug approval submissions without having to share our proprietary information directly with our partners.

23Where common data elements may be part of several submissions for regulatory approval, as in the case of information supporting an injection system, a MAF filing with the FDA may be the preferred route. A delivery device that is applicable to a variety of drug/device combination products, represents another opportunity for such a filing. Another option would be to obtain a 510(k) premarket clearance, de novo authorization, or premarket approval (“PMA”) from the FDA for our delivery device as a stand-alone product. The type of premarket submission required is based on the FDA device classification for the delivery device (Class I, II, III, or not yet classified). We intend to pursue such strategies as permitted by the law and as directed by the FDA either through guidance documents or discussions.

~~and~~Development ~~our~~of ~~partners’~~a ~~combination~~device ~~products~~with ~~have~~a ~~been~~specific ~~regulated as~~ drug, ~~and~~will ~~are~~likely ~~therefore~~be ~~subject~~handled toas ~~the~~part ~~NDA, ANDA, sNDA, sANDA and 505(b)(2) drug approval process and regulations. Combination drug/device products raise unique scientific, technical and regulatory issues. The FDA has established an Office~~ of ~~Combination Products (“OCP”) to address~~ the ~~challenges~~marketing ~~associated~~application ~~with the review and regulation of combination products. The OCP assists in determining strategies~~ for the ~~approval of~~ drug~~/delivery~~ ~~combinations~~product, ~~and~~which ~~assuring agreement within the FDA on review responsibilities. The device specific information is filed with FDA as part of the drug approval submission or it~~ may be ~~filed~~an ~~separately~~NDA, inANDA, ~~the~~or ~~form~~supplemental ofapplication. aUnder ~~device~~these ~~master file~~circumstances, ~~also known as~~ the ~~master~~device ~~access~~component ~~file (“MAF”). MAF~~ is ~~not an FDA approval submission but is a filing that can be used to provide supporting data for our partners’ drug approval submissions. A MAF will be reviewed by the FDA~~ only ~~when~~approved ~~referenced~~if ~~in an approval submission. By filing a MAF, we are able to provide information directly to~~ the ~~FDA, which can then be referenced by our partners in their~~ drug ~~approval~~component ~~submissions,~~is ~~without having to share our proprietary information directly with our partners~~approved.

~~Where~~To ~~common~~the ~~data~~extent ~~elements~~that ~~may~~our beinjectors are packaged with the drug as part of ~~several~~a ~~submissions~~drug ~~for~~delivery ~~regulatory approval~~system, asthe inentire package will be subject to the ~~case~~requirements offor ~~information~~drug/device ~~supporting~~combination anproducts. ~~injection~~These ~~system~~include drug manufacturing requirements, adrug ~~MAF~~adverse ~~filing~~reaction ~~with~~and ~~the~~other ~~FDA~~reporting ~~may~~requirements, beand all of the ~~preferred~~restrictions ~~route~~that apply to drug labeling and advertising. A ~~delivery~~Additionally, ~~device~~such ~~that~~products iswill ~~applicable~~also tobe asubject ~~variety~~to ofcertain ~~drug/~~device ~~combination products~~requirements, ~~represents~~including ~~another~~QSRs ~~opportunity~~and ~~for~~certain reporting requirements, such aas ~~filing~~medical device reports. ~~Another~~ Sponsors ~~option~~of ~~would~~clinical bestudies tousing ~~obtain~~investigational adevices ~~510(k)~~are ~~premarket~~also ~~clearance~~required ~~from~~to ~~FDA~~comply ~~for~~with ~~our~~the ~~delivery~~FDA’s investigational device asexemption aregulations. These ~~stand-alone~~requirements ~~product.~~necessitate Weadditional ~~intend~~expenditures toof ~~pursue~~time ~~such~~and ~~strategies~~resources, aswhich ~~permitted~~could byhave ~~the~~a ~~law~~substantial ~~and~~adverse asimpact ~~directed~~on byour ~~the~~ability ~~FDA~~to ~~either~~commercialize ~~through~~our ~~guidance~~products ~~documents~~and orour ~~discussions~~operations.

Development of a device with a specific drug likely will be handled as part of the marketing application for the drug product, which may be a NDA, ANDA, or supplemental application. Under these circumstances, the device component is only approved if the drug component is approved.31

ToTable ~~the extent that our injectors are packaged with the drug, as part~~ of a drug delivery system, the entire package will be subject to the requirements for drug/device combination products. These include drug manufacturing requirements, drug adverse reaction and other reporting requirements, and all of the restrictions that apply to drug labeling and advertising. Additionally, such products will also be subject to certain device requirements, including QSRs and certain reporting requirements, such as medical device reports. Sponsors of clinical studies using investigational devices are also required to comply with FDA’s investigational device exemption regulations. These requirements necessitate additional expenditures of time and resources, which could have a substantial adverse impact on our ability to commercialize our products and our operations.Contents

Other Post-Approval Requirements and Promotional Activities

Any product manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements related to manufacturing, recordkeeping, reporting, including adverse experience reporting, drug shortage reporting, ~~and~~ periodic reporting, product sampling and distribution, advertising, marketing, ~~and~~ promotion, and post‑approval obligations imposed as a condition of approval, such as Phase IV clinical trials, REMS, and surveillance to assess safety and effectiveness after commercialization.

There also are continuing annual user fee requirements. In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register and, in the case of generic drug products, self-identify their establishments with the FDA and certain state agencies and list their drug products. Device manufacturers must also register their facilities and list the devices that they design, develop, manufacture, or import, except those subject to a drug approval. These facilities must also pay annual registration fees. The distribution of prescription pharmaceutical product samples is also subject to the Prescription Drug Marketing Act (“PDMA”).

~~The~~ FDA ~~closely regulates the~~ post-approval ~~marketing~~requirements ~~and~~are ~~promotion~~continually ofevolving. ~~drugs~~For ~~and devices~~example, ~~including~~in ~~standards~~March ~~and regulations for direct-to-consumer advertising~~2020, ~~dissemination of off-label information, industry-sponsored scientific and educational activities and promotional activities involving~~ the ~~Internet~~U.S. ~~Drugs~~Congress ~~may~~passed ~~be marketed only for~~ the ~~approved~~Coronavirus ~~indications~~Aid, Relief, and inEconomic ~~accordance~~Security ~~with~~Act (the ~~provisions~~“CARES ofAct”) ~~the~~which ~~approved~~includes ~~label.~~various ~~Further,~~provisions ifregarding ~~there~~FDA ~~are any modifications to the~~ drug, ~~including~~shortage ~~changes~~and ~~in indications, labeling, or~~ manufacturing ~~processes~~volume orreporting ~~facilities~~requirements, weas ~~may~~well beas ~~required~~provisions toregarding ~~submit~~supply ~~and~~chain ~~obtain FDA approval of a new or supplemental NDA~~security, ~~which~~such ~~may~~as ~~require~~risk usmanagement toplan ~~develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these~~ requirements ~~can result in adverse publicity~~, ~~Warning~~and ~~Letters,~~the ~~Untitled~~promotion ~~Letters,~~of ~~corrective~~supply ~~advertising~~chain ~~and~~redundancy ~~potential civil~~ and ~~criminal~~domestic ~~penalties,~~manufacturing. asAs ~~well~~part asof ~~liability under~~ the ~~civil~~CARES ~~False Claims~~ Act implementation, ~~exclusion~~the ~~from~~FDA ~~participation~~recently inissued ~~federal~~guidance ~~healthcare~~on ~~programs,~~the ~~mandatory~~reporting ~~compliance~~of ~~programs~~the ~~under~~volume ~~corporate~~of ~~integrity~~drugs ~~agreements~~produced, ~~debarment,~~which ~~and~~reporting ~~refusal~~will ofrequire ~~government~~additional ~~contracts~~administrative ~~among~~efforts ~~other~~by ~~consequences~~drug manufacturers.

~~Physicians~~The ~~may~~FDA ~~prescribe~~closely ~~legally~~regulates ~~available~~the ~~products~~post-approval ~~for~~marketing ~~uses~~and ~~that~~promotion ~~are~~of ~~not~~drugs ~~described~~and indevices, ~~the~~including ~~product’s~~standards ~~labeling~~ and ~~that~~regulations ~~differ~~for ~~from~~direct-to-consumer ~~those~~advertising, ~~tested~~dissemination byof usoff-label information, industry-sponsored scientific and ~~approved~~educational byactivities and promotional activities involving the ~~FDA~~Internet. ~~Physicians~~Drugs may ~~believe~~be ~~that~~marketed ~~such~~only ~~off-~~for the approved indications and in accordance with the provisions of the approved label. ~~uses~~Further, if there are ~~the~~any ~~best~~modifications ~~treatment~~to ~~for~~the ~~many~~drug, ~~patients~~including changes in ~~varied~~indications, ~~circumstances.~~labeling ~~The~~or manufacturing processes or facilities, we may be required to submit and obtain FDA ~~does~~approval ~~not~~of ~~regulate~~a new or supplemental NDA, which may require us to develop additional data or conduct additional preclinical studies and clinical trials. Failure to comply with these requirements can result in adverse publicity, Warning Letters, Untitled Letters, corrective advertising and potential civil and criminal penalties, as well as liability under the ~~behavior~~civil ofFalse ~~physicians~~Claims Act, exclusion from participation in ~~their~~federal ~~choice~~healthcare ofprograms, ~~treatments.~~mandatory ~~The~~compliance ~~FDA~~programs ~~does~~under corporate integrity agreements, ~~however~~debarment, and refusal of government contracts among other consequences.

24Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use. Specifically, manufacturers and product sponsors may not promote a product for off-label uses and must also comply with the FDA’s other promotional requirements.

impose stringent restrictions on manufacturers’ communications regarding off-label use. Specifically, manufacturers and product sponsors may not promote a product for off-label uses and must also comply with FDA’s other promotional requirements.

Manufacturing and Quality Regulations

The FDA established regulations to require that the methods used in, and the facilities and controls used for, the manufacture, processing, packing and holding of drugs and medical devices conform to cGMPs and QSRs. The cGMP regulations the FDA enforces are comprehensive, ~~and~~ cover all aspects of manufacturing operations and require the conduct of investigations and FDA reporting under certain circumstances. The cGMP regulations for devices, called the Quality System Regulation, are also comprehensive and cover all aspects of device design, quality, and manufacturing, including, for example, pre-production design requirements and validation; production and process controls; complaint handling and investigations; corrective and preventative actions; and distribution, installation, and servicing. Compliance with the regulations requires a continuous commitment of time, money and effort in all operational areas. The FDA conducts periodic inspections of drug and device facilities to assess the cGMP/QSR status of marketed products. Before approval of an application, the FDA will typically also conduct facility inspections to ensure cGMP/QSR compliance.

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Controlled Substances Regulation

Certain of our drug products are considered “controlled substances” as defined in the Controlled Substances Act (“CSA”) and implementing regulations, which, depending on the controlled substance schedule, establish certain registration, security, monitoring, reporting, storage, distribution, importation, inventory, quota, record keeping, prescribing, dispensing, and other requirements administered by the Drug Enforcement Agency (“DEA”). The DEA regulates controlled substances as Schedule I, II, III, IV or V substances, with Schedule I and II substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. ~~Our product XYOSTED® is a Schedule III substance.~~ These requirements are directly applicable to us and also applicable to our contract manufacturers and to distributors, prescribers and dispensers of our products.

The DEA regulates the handling of controlled substances through a closed chain of distribution. This control extends to the equipment and raw materials used in their manufacture and packaging, in order to prevent loss and diversion into illicit channels of commerce. Annual registration is required for any facility that manufactures, distributes, imports or exports any controlled substance. The registration is specific to the particular location, activity and controlled substance schedule. The DEA typically inspects a facility to review its security measures prior to issuing a registration and on a periodic basis. Certain reports must also be made for controlled substances, such as reports for thefts or significant losses of any controlled substance and reports of suspicious orders. Failure to maintain compliance with applicable requirements, particularly as manifested in loss or diversion, can result in administrative, civil or criminal enforcement action. Individual states may also regulate controlled substances.

Foreign Approval Process

In addition to regulations in the U.S., we (and, where appropriate, our partners marketing medicinal products incorporating our devices) are subject to various foreign regulations governing clinical trials, manufacturing, and the commercial sales and distribution of our medicinal products. We and/or our partners must obtain approval of a medicinal product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The requirements governing the conduct of clinical trials, manufacturing, product licensing, pricing and reimbursement and the regulatory approval process all vary greatly from country to country. Additionally, the time it takes to complete the approval process in foreign countries may be longer or shorter than that required for FDA approval. Foreign regulatory approvals of our products are necessary whether or not we obtain FDA approval for such products. Finally, before a new drug may be exported from the U.S., it must either be approved for marketing in the U.S. or meet the requirements of exportation of an unapproved drug under Section 802 of the Export Reform and Enhancement Act or comply with FDA regulations pertaining to INDs.

In the ~~European Union (“~~EU”), marketing authorizations for medicinal products can be obtained through several different procedures, principally the centralized procedure, the decentralized procedure and the mutual recognition procedure. The centralized procedure allows a company to submit a single application to the European Medicines Agency (“EMA”), which may provide a positive opinion regarding the application to the effect that it meets certain safety, quality and efficacy requirements. A centralized marketing authorization will be granted based on a positive opinion of the EMA as approved by the European Commission. It is valid in all EU member states and three of the four European Free Trade Association countries (Iceland, Liechtenstein and Norway). The centralized procedure is mandatory for certain medicinal products, including orphan medicinal products and biologic products, and optional for certain other high technology products. The decentralized procedure allows companies to file identical applications for authorization to several EU member states simultaneously for medicinal products that have not yet been authorized in any EU member state. The competent authority of one EU member state, selected by the applicant (the Reference Member State), assesses the application for marketing authorization. The competent authorities of the other EU member states for which marketing authorizations are sought (concerned member states) are subsequently required to grant marketing authorization for their territories on the basis of this assessment except where grounds of potential serious risk to public health require an authorization to be refused. This procedure allows companies that have a medicinal product already authorized in one EU member state to apply for this authorization to be recognized by the competent authorities in other EU member states. The mutual recognition procedure applies in the case where a marketing authorization for the same medicinal product has already been granted by an EU/European Economic Area (“EEA”) member state, whereas the decentralized procedure is applicable if no marketing authorization exists. Since January 1, 2021, the United Kingdom has separate approval processes to the EU as a consequence of Brexit.

2533

InTable ~~so far as our products may be sold as medical devices outside~~ of the U.S. (as opposed to a delivery system of a medicinal product) we are also subject to foreign legal and regulatory requirements. Legal restrictions on the sale of imported medical devices and products vary from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. We primarily rely upon the companies marketing our injectors in foreign countries to obtain the necessary regulatory approvals for sales of our products in those countries. Contents

~~Our~~In ~~Minneapolis~~so ~~Quality~~far ~~Management~~as ~~System~~our ~~has~~products ~~ISO~~may ~~13485:~~be ~~2003~~placed ~~certification,~~on the ~~medical~~market ~~device~~as ~~industry~~medical ~~standard~~devices ~~for~~outside ~~our~~of ~~quality~~the ~~systems~~U.S. ~~This~~(as ~~certification~~opposed ~~shows~~to ~~that~~a ~~our~~delivery ~~device~~system ~~development~~of ~~and~~a ~~manufacturing~~medicinal ~~comply~~product), ~~with~~we ~~standards~~are ~~for~~also ~~quality~~subject ~~assurance,~~to ~~design~~foreign ~~capability~~legal and ~~manufacturing~~regulatory ~~process control~~requirements. ~~Such~~Legal ~~certification,~~restrictions ~~along~~on ~~with compliance with~~ the ~~European~~sale ~~Medical~~of ~~Device~~imported ~~Directive~~medical ~~93/42/EC~~devices ~~(to~~and beproducts ~~replaced~~vary onfrom ~~May~~country ~~27,~~to ~~2020~~country. byThe ~~the~~time EUrequired ~~Medical~~to ~~Devices~~obtain ~~Regulation~~approval ~~2017/745),~~by ~~enables~~a usforeign tocountry ~~affix~~may ~~the~~be CElonger ~~Mark~~or (ashorter ~~certification~~than ~~indicating~~ that arequired ~~product~~for ~~has~~FDA ~~met EU consumer safety~~approval, ~~health~~and orthe ~~environmental~~ requirements) tomay ~~current~~differ. ~~products~~We ~~and~~primarily ~~supply~~rely upon the ~~device~~companies’ ~~with~~marketing aour ~~Declaration~~injectors ofin ~~Conformity.~~foreign ~~Regular~~countries ~~surveillance~~to ~~audits~~obtain bythe ~~our~~necessary ~~notified~~regulatory ~~body,~~approvals ~~British~~for ~~Standards~~sales ~~Institute,~~of ~~are~~our ~~required~~products toin ~~demonstrate~~those ~~continued compliance~~countries.

Our Minneapolis Quality Management System has ISO 13485: 2003 certification, the medical device industry standard for our quality systems. This certification shows that our device development and manufacturing comply with standards for quality assurance, design capability and manufacturing process control. Such certification, along with compliance with the EU Medical Devices Regulation 2017/745 (which replaced the European Medical Device Directive 93/42/EC on May 27, 2020), enables us to affix the CE Mark (a certification indicating that a product has met EU consumer safety, health or environmental requirements) to current products and supply the device with a Declaration of Conformity. Regular surveillance audits by our notified body, British Standards Institute, are required to demonstrate continued compliance.

Other Healthcare Laws and Compliance Requirements

In the U.S., the research, manufacturing, distribution, marketing, sale and promotion of drug products and medical devices are subject to numerous regulations by various federal, state and local authorities.

We are subject to various U.S. federal and state laws restricting certain marketing practices in the pharmaceutical industry, including anti-kickback laws and false claims laws. The federal healthcare program ~~anti~~Anti-~~kickback~~Kickback Statute is a criminal statute that prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce, reward or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs, except for activities protected by narrowly-drawn statutory and regulatory safe harbors. HHS recently promulgated a regulation that is effective in two phases. First, the regulation excludes from the definition of “remuneration” limited categories of (a) PBM rebates or other reductions in price to a plan sponsor under Medicare Part D or a Medicaid Managed Care Organization plan reflected in point-of sale reductions in price and (b) PBM service fees. Second, effective January 1, ~~2022~~2023, the regulation expressly provides that rebates to plan sponsors under Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager will not be protected under the anti-kickback discount safe harbor. Liability under the federal ~~anti~~Anti-~~kickback~~Kickback ~~statute~~Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it, and a violation of the ~~anti~~Anti-~~kickback~~Kickback ~~statute~~Statute may be grounds for a government or whistleblower claim under the federal False Claims Act. Violations of the federal ~~anti~~Anti-~~kickback~~Kickback ~~statute~~Statute may be punished by civil and criminal fines, imprisonment, and/or exclusion from participation in federal healthcare programs. Separately, the Beneficiary Inducement Civil Monetary Penalties Law imposes similar restrictions on interactions between the biopharmaceutical industry and federal healthcare program beneficiaries.

The federal civil False Claims Act prohibits, among other things, any person from knowingly presenting or causing to be presented a false or fraudulent claim for payment of federal funds; knowingly making or causing to be made, a false statement to get a false claim paid; knowingly making, using or causing to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government; conspiring to defraud the government by getting a false or fraudulent claim paid or approved by the government; or knowingly making, using or causing to be made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government. Claims may be pursued by whistleblowers through qui tam actions, even if the government declines to intervene. Intent to deceive is not necessary to establish civil liability, which may be predicated on reckless disregard for or deliberate ignorance of the truth. The civil False Claims Act authorizes imposition of treble damages and a civil penalty for each false claim, such as an invoice, submitted for payment and may result in significant financial penalties and damages. The criminal federal False Claims Act imposes criminal fines or imprisonment against individuals or entities who make or present a claim to the government knowing such claim to be false fictitious or fraudulent. Conviction or civil judgment for violation of the False Claims Act can also result in debarment from government ~~contracting~~procurement programs and exclusion from participation in federal healthcare programs.

The ~~civil~~Civil ~~monetary~~Monetary ~~penalties~~Penalties ~~statute~~Statute further imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal ~~health~~healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Federal consumer protection and unfair competition laws also broadly regulate marketplace activities and activities that potentially harm consumers.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), also created federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in 34

26Table of Contents

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), also created federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private), knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. The ACA amended the intent requirement of certain of these criminal statutes so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to violate it.

Various federal and state ~~health~~healthcare ~~care~~ programs obligate us to report drug pricing information that is used as the basis for their reimbursement rates for pharmacies and other ~~health~~healthcare ~~care~~ providers including under the Medicaid and Medicare programs, prices charged certain federal agencies and non-federal purchasers, and required manufacturer rebates on prescriptions paid by Medicaid and other plans. Payment for a manufacturer’s drugs by these programs is conditioned on submission of this pricing information. States, such as California, have also enacted transparency laws that require manufacturers to report price increases and related information. Some government ~~health~~healthcare ~~care~~ programs impose penalties if drug price increases exceed specified percentages or inflation rates, and these penalties can result in mandatory penny prices for certain federal and 340B program customers or rebates equal to 100% of average price. Failure to comply with the rules for calculating and submitting pricing information or otherwise overcharging the government or its beneficiaries may result in criminal, civil, or administrative sanctions or enforcement actions, including False Claims Act liability.

In addition, the Physician Payment Sunshine Act provisions of the Healthcare Reform Act require extensive tracking of certain payments and other transfers of value to physicians (as defined tounder ~~include~~the ~~doctors,~~Social ~~dentists,~~Security ~~optometrists, podiatrists and chiropractors~~Act), certain other types of healthcare ~~providers~~professionals (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives licensed in the U.S.), and U.S. teaching hospitals, as well as ownership and investment interest held by physicians and their immediate family members,. Payments made to principal investigators and research institutions at teaching hospitals for clinical trials are also included within this law for reporting purposes. These payments and other transfers of ~~the~~value ~~data~~are ~~collected~~required to be reported to the Centers for Medicare and Medicaid Services (“CMS”), which publishes the data publicly on the CMS Open Payments website. Government agencies and private entities may inquire about our marketing practices, and government entities may pursue enforcement activities based on the disclosures in those public reports. Similar state laws also impose reporting requirements for various types of payments and other transfers of value to healthcare providers and organizations, including marketing and promotional expenses, and impose various types of gift bans and other compliance requirements on manufacturers. Failure to comply with required reporting requirements, gift bans and other compliance requirements under these laws could subject manufacturers and others to substantial civil money penalties.

The majority of states also have statutes or regulations similar to the federal consumer protection and unfair competition laws, ~~federal anti~~Anti-~~kickback~~Kickback ~~law~~Statute and ~~the~~civil False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply to reimbursement for healthcare items and services regardless of the payer type, including private payers. A number of states now have implemented transparency laws requiring manufacturers to report pricing information and require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to individual physicians in the states. Other states restrict when and where pharmaceutical companies may provide meals to prescribers or engage in other marketing related activities. In addition, some states require pharmaceutical companies to abide by the pharmaceutical industry’s voluntary compliance guidelines, and implement compliance programs or marketing codes of conduct. Failure to comply with state laws could result in regulatory enforcement actions, including the assessment of significant administrative penalties.

Although we may not provide financial assistance to Medicare patients taking drugs sold by us, the Office of Inspector General (“OIG”) has established guidelines that permit pharmaceutical manufacturers to make donations to charitable organizations ~~who~~that provide co-pay assistance to Medicare patients, provided that such organizations, among other things, are bona fide charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come basis according to consistent objective financial criteria, and do not link aid to use of a donor’s product. If we, or our vendors or donation recipients are deemed to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we could be subject to damages, fines, penalties or other criminal, civil or administrative sanctions or enforcement actions.

The Veterans Health Care Act of 1992 requires, as a condition of payment by certain federal agencies and the Medicaid program, that manufacturers of “covered drugs” enter into a Master Agreement and Federal Supply Schedule (FSS) contract with the Department of Veterans Affairs through which their covered drugs must be offered for sale at a mandatory ceiling price to certain federal agencies, including the VA and Department of Defense. FSS contracts require compliance with applicable federal procurement laws and regulations, including disclosure of commercial prices during contract negotiations and maintenance of price relationships during the term of the contract, and subject manufacturers to contractual remedies as well as administrative, civil, and criminal sanctions. The Veterans Health Care Act also requires manufacturers to enter into pricing agreements with the Department of Health and Human Services to charge no more than a different ceiling price (derived from the Medicaid rebate percentage) to covered entities participating in the 340B drug discount program. Failure to provide the mandatory discount may subject the manufacturer to specific civil monetary penalties, including when subsequent ceiling price recalculations due to pricing data submitted to CMS or new drug price estimations result in a covered entity having paid more that the revised ceiling price due to failure or refusal to refund or credit a covered entity. Termination of either of these agreements also jeopardizes payment by Medicaid for the manufacturer’s drugs.35

~~The~~Table ~~Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act~~ of 2010, which we refer to together as the Healthcare Reform Act, expanded healthcare coverage within the U.S., primarily through establishment of state insurance exchanges and expansion of the Medicaid program. This law substantially changed the way healthcare is financed by both governmental and private insurers and significantly impacts the pharmaceutical industry. Changes that may affect Contents

27The Veterans Health Care Act of 1992 requires, as a condition of payment by certain federal agencies and the Medicaid program, that manufacturers of “covered drugs” enter into a Master Agreement, Pharmaceutical Pricing Agreement, and Federal Supply Schedule (“FSS”) contract with the Department of Veterans Affairs through which their covered drugs must be offered for sale at a mandatory ceiling price to certain federal agencies, including the VA and Department of Defense. FSS contracts require compliance with applicable federal procurement laws and regulations, including disclosure of commercial prices during contract negotiations and maintenance of price relationships during the term of the contract, and subject manufacturers to contractual remedies as well as administrative, civil and criminal sanctions. The Veterans Health Care Act also requires manufacturers to enter into pricing agreements with the Department of Health and Human Services to charge no more than a different ceiling price (derived from the Medicaid rebate percentage) to covered entities participating in the 340B drug discount program. Failure to provide the mandatory discount may subject the manufacturer to specific civil monetary penalties, including when subsequent ceiling price recalculations due to pricing data submitted to CMS or new drug price estimations result in a covered entity having paid more that the revised ceiling price and the manufacturer has failed or refused to refund or credit a covered entity. Termination of either of these agreements under the Veterans Health Care Act also jeopardizes payment by Medicaid for the manufacturer’s drugs.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, which we refer to together as the Healthcare Reform Act, expanded healthcare coverage within the U.S., primarily through establishment of state insurance exchanges and expansion of the Medicaid program. This law substantially changed the way healthcare is financed by both governmental and private insurers and significantly impacts the pharmaceutical industry. Changes that may affect our business include those governing enrollment in federal healthcare programs, reimbursement changes, payment of an annual fee by manufacturers of branded drugs and biological products based on their share of the federal market, benefits for patients within a coverage gap in the Medicare Part D prescription drug program (commonly known as the “donut hole”), rules regarding prescription drug benefits under the health insurance exchanges, changes to the Medicaid Drug Rebate program, expansion of the Public Health Service’s 340B drug pricing discount program, and fraud and abuse ~~and~~ enforcement. These changes impact existing government healthcare programs and are resulting in the development of new programs, including Medicare payment for performance initiatives and improvements to the physician quality reporting system and feedback program. The Affordable Care Act has since been amended to repeal the individual health insurance mandate, change price reporting rules for authorized generics, and increase manufacturers’ share of Medicare Part D prescription costs in the donut hole, and other provisions of the law may be repealed and replaced by Congress, which may greatly affect these government and third-party programs and their effect on our business.

In addition, we may be subject to, or our marketing activities may be limited by, data privacy and security regulation by both the federal government and the states in which we conduct our business. One such statute is the Health Insurance Portability and Accountability Act of 1996 ("“HIPAA"”) and its implementing regulations, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”). HIPAA established uniform federal standards for "“covered entities,"” which are certain healthcare providers, health plans and healthcare clearinghouses, as well as their business associates, governing the conduct of specified electronic healthcare transactions, protecting the security and privacy of protected health information, and mandating security breach notification standards. In addition, other federal and state privacy laws, such as the California Consumer Privacy Act, may govern the privacy and security of ~~health~~personal ~~and other~~ information in certain circumstances, many of which differ from each other in significant ways ~~and may not be preempted by HIPAA~~, thus complicating compliance efforts.

The Foreign Corrupt Practices Act (“FCPA”) further prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the U.S., can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.

If our operations are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, disgorgement, contractual damages, reputational harm, exclusion from participation in government healthcare programs, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations. In particular, in the EU the data privacy regime (the General Data Protection Regulation which came into effect on May 25, 2018) is regarded as stricter than the US data protection laws. EU laws restrict the export of personal data outside the EU, for instance to the US, unless certain safeguards are in place.36

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If our operations are found to be in violation of any of the healthcare regulatory laws described above or any other laws that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, disgorgement, contractual damages, reputational harm, exclusion from participation in government healthcare programs, debarment prohibiting participation in government procurement and non-procurement covered transactions, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, private qui tam actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations. In particular, in the EU the data privacy regime (the General Data Protection Regulation which came into effect on May 25, 2018) is regarded as stricter than the U.S. data protection laws. EU laws restrict the export of personal data outside the EU, for instance to the U.S., unless certain safeguards are in place. EU laws and industry codes also restrict certain marketing practices, including inappropriate inducements.

Third-Party Payer Coverage and Reimbursement

The commercial success of the approved products in our portfolio depends, in part, upon the availability of coverage and adequate reimbursement from third-party payers at the federal, state and private levels. Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payers to reimburse all or part of the associated healthcare costs. Sales of our product portfolio will therefore depend substantially, both domestically and abroad, on the extent to which the costs of our product portfolio will be paid by health maintenance, managed care, pharmacy benefit, and/or similar healthcare management organizations, or are reimbursed by government health administration authorities, such as Medicare and Medicaid, private ~~health~~healthcare coverage insurers and other third-party payers. The market for our product portfolio will depend significantly on access to third-party payers'’ formularies or lists of treatments for which third-party payers provide coverage and reimbursement.

Also, third-party payers are developing increasingly sophisticated methods of controlling healthcare costs. For example, for high -cost specialty drugs, third party payers have begun demanding value-based pricing in which price is linked to performance metrics. Recent ~~State~~state enactments establish significant negative incentives requiring negotiation of supplemental rebates, and a recent CMS regulation, ~~effective~~implemented ~~January 1, 2021, implements~~ a most-favored nations pricing model seeking to lower prices under Medicare Part B by tying the costs of certain medicines to cheaper prices in other developed countries. This regulation ~~currently~~was isrescinded ~~the~~by ~~subject~~a offinal ~~litigation~~rule published December 29, 2021; however, legislative and aexecutive ~~temporary~~branch ~~injunction~~proposals also seek to establish this type of pricing for certain federal healthcare programs. ~~Moreover~~ Further, ~~while~~coverage itand isreimbursement ~~only~~for ~~currently~~therapeutic ~~applicable~~products can differ significantly from payer to ~~Medicare~~payer. ~~Part~~As Ba result, ~~legislative~~the coverage determination process will require us to provide scientific and ~~executive~~clinical ~~branch~~support ~~proposals~~for ~~have~~the ~~sought~~use of our products to ~~extend~~each ~~this~~payer ~~type~~separately, with no assurance that adequate coverage and reimbursement will be obtained. The cost of pharmaceuticals and medical devices continues to generate substantial governmental and third-party payer scrutiny. We expect that the pharmaceutical industry will experience continued pricing pressures due to ~~other~~the ~~federal~~trend toward managed healthcare, ~~programs~~the increasing influence of managed care organizations and additional legislative and administrative proposals. ~~Further,~~Our ~~coverage~~results of operations and ~~reimbursement~~business could be adversely affected by current and future third-party payer policies as well as healthcare legislative and administrative reforms.

for therapeutic products can differ significantly from payer to payer. As a result, the coverage determination process will require us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that adequate coverage and reimbursement will be obtained. The cost of pharmaceuticals and medical devices continues to generate substantial governmental and third-party payer scrutiny. We expect that the pharmaceutical industry will experience continued pricing pressures due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative and administrative proposals. Our results of operations and business could be adversely affected by current and future third-party payer policies as well as healthcare legislative and administrative reforms.

Some third-party payers also require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers who use such therapies. While we cannot predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, these requirements or any announcement or adoption of such proposals could have a material adverse effect on our ability to obtain adequate prices for our product portfolio and to operate profitably.

In international markets, there are health technology assessment regimes with price ceilings and supply and demand side restraints on specific products and therapies and profit controls in ~~certain~~most ~~countries~~EU ~~including~~member states as well as the UKUnited Kingdom. There can be no assurance that our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third-party payers, that an adequate level of reimbursement will be available or that the third-party payers'’ reimbursement policies will not adversely affect our ability to sell our products profitably.

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Healthcare Reform

In the U.S. and foreign jurisdictions, the legislative landscape continues to evolve. There have been a number of legislative and regulatory changes to the healthcare system that will likely affect our future operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs, improve access, and improve quality. The Affordable Care Act (“ACA”), passed in 2010, provided more Americans with ~~health~~healthcare ~~care~~ coverage while attempting to curb the growth in healthcare spending in the U.S. The legislation included reforms to patient rights and protections, rules for insurance companies, taxes, tax breaks, funding, and spending, and amended other laws including the Food, Drug and Cosmetics Act. Since enactment of the ACA, some of its provisions have been repealed or amended, and other provisions may be repealed and replaced by Congress. Some of the main provisions of the ACA that affected the pharmaceutical and biotechnology industry include, among others, the following:

• an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

• an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively, and inclusion of Medicaid managed care plan utilization in manufacturers’ rebate obligations;

• new methodologies by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated;

• a new Medicare Part D coverage gap discount program;

• expansion of eligibility criteria for Medicaid programs thereby potentially increasing manufacturers'’ Medicaid rebate liability;

• expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

• expansion of healthcare fraud and abuse laws, including the federal civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;.

The Drug Supply Chain Security Act imposes on manufacturers of certain pharmaceutical products obligations related to product tracking and tracing, among others. Among the requirements of this legislation, manufacturers are required to provide certain information regarding the drug product to individuals and entities to which product ownership is transferred, ~~are required to~~ label the drug product with a product identifier, and ~~are required to~~ keep certain records regarding the drug product. The transfer of information to subsequent product owners by manufacturers is required to be done electronically. Manufacturers are also required to verify that purchasers of the manufacturers'’ products are appropriately licensed. Further, manufacturers have drug product investigation, quarantine, disposition, and FDA and trading partner notification responsibilities related to counterfeit, diverted, stolen, and intentionally adulterated products that would result in serious adverse health consequences or death to humans, as well as products that are the subject of fraudulent transactions or which are otherwise unfit for distribution such that they would be reasonably likely to result in serious health consequences or death. Similar requirements are also imposed on other trading partners in the supply chain.

We expect that additional state and federal healthcare reform measures will be adopted in the future. Legislators and regulators at both the federal and state level are increasingly focused on containing the cost of drugs, and there has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug pricing practices. Specifically, there have been recent U.S. ~~Congressional~~congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient support programs, and reform government program reimbursement methodologies for drugs. For example, California enacted a transparency law requiring manufacturers to report drug price increases and related information, including the reasons for the price increases. Congress also amended the Medicaid statute to alter price reporting of branded products sold as authorized generics, which effectively increases the rebates paid on the brand. Recent executive orders focusing on domestic sourcing also have required government agencies, to the maximum extent practicable, to limit procurement of essential medicines, including epinephrine, to products that are manufactured in the U.S. from U.S. API and other critical inputs. The list of essential medicines is established by the FDA and subject to change. These and any additional healthcare reform and procurement measures could further constrain our business or limit the amounts that federal and state governments will pay for healthcare products and services, which could result in additional pricing pressures.

2938

~~relationship~~Table between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. For example, California recently enacted a transparency law requiring manufacturers to report drug price increases and related information. Congress also amended the Medicaid statute to alter price reporting of branded products sold as authorized generics, effective 4th quarter 2019, which effectively increases the rebates paid on the brand. Recent executive orders focusing on domestic sourcing also have required that government agencies to the maximum extent practicable limit procurements of essential medicines, including epinephrine, to products that are manufactured in the US from US API and other critical inputs. These and any additional healthcare reform and procurement measures could further constrain our business or limit the amounts that federal and state governments will pay for healthcare products and services, which could result in additional pricing pressures.Contents

Other Regulatory Requirements and Considerations

In addition to regulations enforced by the FDA, we must also comply with regulations under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state and local regulations. We are also subject to various laws and regulations regarding laboratory practices, the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances in connection with our research. In each of these areas, as above, the FDA and other government agencies have broad regulatory and enforcement powers, including, among other things, the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall products, and withdraw approvals, any one or more of which could have a material adverse effect on us. The effects of potential future changes in regulations or new legislation, if any, as a result of the new administration are also unknown.

Available Information

We file with the U.S. Securities and Exchange Commission (“SEC”) annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and other documents as required by applicable law and regulations. The SEC maintains ana ~~Internet~~website ~~site~~ (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. We ~~maintain an Internet site (http://www.antarespharma.com). We~~ make available free of charge on or through our ~~Internet~~ website (http://www.antarespharma.com) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and if applicable, amendments to ~~these~~those reports filed or furnished pursuant to the Exchange Act, as soon as reasonably practicable after electronically filing those documents with or furnishing them to the SEC. The information on our website is not incorporated into and is not a part of this ~~annual~~Annual report on Form 10-K.

30ITEM 1A. RISK FACTORS

~~Item~~The 1Afollowing “risk factors” contain important information about us and our business and should be read in their entirety. ~~RISK~~Additional ~~FACTORS~~risks and uncertainties not known to us or that we now believe to be not material could also impair our business. If any of the following risks actually occur, our business, results of operations and financial condition could suffer significantly. As a result, the market price of our common stock could decline, and you could lose all of your investment. In this Section, the terms the “Company,” “we”, “our” and “us” refer to Antares Pharma, Inc.

The following “risk factors” contain important information about us and our business and should be read in their entirety. Additional risks and uncertainties not known to us or that we now believe to be not material could also impair our business. If any of the following risks actually occur, our business, results of operations and financial condition could suffer significantly. As a result, the market price of our common stock could decline and you could lose all of your investment. In this Section, the terms the “Company,” “we”, “our” and “us” refer to Antares Pharma, Inc.

Risks Related to Our Operations

We have ~~historically~~significant ~~incurred~~outstanding ~~significant~~indebtedness ~~losses,~~under a loan and ~~there~~security isagreement. If nowe ~~guarantee~~do not have sufficient cash available to repay the outstanding indebtedness as it becomes due, or if an event of default were to occur that weprovides ~~can~~Wells ~~sustain~~Fargo Bank, National Association the right to accelerate the outstanding balance of the loan and to take possession of some or ~~grow~~all of our ~~profitability~~collateral securing the loan, either situation could have a material adverse effect on our business.

~~Although~~On November 1, 2021, we ~~generated~~entered ~~$56.2~~into ~~million~~a ofCredit ~~net~~Agreement ~~income~~(the “Credit Agreement”) with Wells Fargo Bank, National Association, as administrative agent for the ~~year~~lenders, ~~ended~~for ~~December~~credit ~~31,~~facilities ~~2020~~in an aggregate principal amount of up to $40.0 million with a maturity date of November 1, we2024. ~~incurred~~The ~~net~~Credit ~~losses~~Agreement consists of a $220.0 million term loan facility (the “Term Loan Facility”) and a $620.0 million revolving credit facility, $5.0 million of which is available for the ~~years~~issuance ~~ended~~of ~~December~~letters ~~31,~~of ~~2019~~credit and ~~2018, respectively~~$1.0 Inmillion ~~addition,~~of wewhich ~~had~~is anavailable ~~accumulated~~for ~~deficit~~swingline atloans ~~December 31~~(the “Revolving Credit Facility”), ~~2020~~(collectively the “Credit Facilities”), which are secured by substantially all of ~~$222.6~~our ~~million~~assets. The ~~costs~~Term ~~for~~Loan ~~research~~Facility ~~and~~was ~~development~~funded upon execution of the Credit Agreement with the proceeds used to repay our ~~products,~~$20.0 ~~product~~million ~~candidates~~Term Loan with Hercules Capital and ~~drug~~to ~~delivery~~pay ~~technologies,~~fees ~~along~~and expenses incurred in connection with ~~marketing~~the early repayment. The Revolving Credit Facility remains available for future use and ~~selling~~is ~~expenses~~expected to be used for ongoing working capital requirements and other general ~~and~~corporate ~~administrative~~purposes ~~expenses,~~as ~~have~~needed. ~~been~~Payments under the ~~principal~~Term ~~causes~~Loan ofFacility ~~our~~are ~~losses.~~due ~~Although~~in weconsecutive ~~have~~quarterly ~~reported~~installments ~~net~~on ~~earnings~~the ~~and~~last ~~earnings~~business ~~per~~day ~~share~~of ineach ~~recent~~of ~~quarters~~March, June, September and ~~for~~December, commencing on March 31, 2022. Interest accrues at either the ~~most~~base ~~recent~~rate ~~annual~~or ~~period~~LIBOR plus the applicable margin, ~~there~~which isvaries nobased ~~guarantee~~on weour consolidated total leverage ratio and will ~~continue~~initially be 1.50% for base rate loans and 2.50% for LIBOR loans. The transaction is expected to ~~post~~provide ~~profitable~~approximately ~~results~~$1.2 ofmillion ~~operations~~in orannual ~~maintain~~interest ~~profitability~~expense savings based on an ~~annual~~interest orrate ~~quarterly~~of ~~basis,~~approximately ~~and~~2.60% as(one-month aLIBOR ~~result~~rate ~~your~~plus ~~investment~~the ~~could~~applicable bemargin ~~harmed~~of 2.50%) as of December 31, 2021.

We have significant outstanding indebtedness under a loan and security agreement. If we do not have sufficient cash available to repay the outstanding indebtedness as it becomes due, or if an event of default were to occur that provides Hercules Capital, Inc. the right to accelerate the outstanding balance of the loan and to take possession of some or all of our collateral securing the loan, either situation could have a material adverse effect on our business.

We have entered into a loan and security agreement, referred to herein as the Hercules Loan Agreement, with Hercules Capital, Inc., (“Hercules”) for a term loan of up to $50.0 million, under which we have borrowed a total of $40.0 million. The loan is secured by substantially all of the Company’s assets, excluding intellectual property, and will mature on July 1, 2022, unless extended to July 1, 2024 contingent upon satisfaction of a certain loan extension milestone. Under the Hercules Loan Agreement, an event of default will occur if, among other things, we fail to make payments as required under the Hercules Loan Agreement, we breach or default in the performance of any covenant or secured obligation under the Hercules Loan Agreement, a circumstance occurs that would reasonably be expected to have a material adverse effect on the Company, we become unable to pay our debts as they come due or are otherwise insolvent, we or our assets become subject to certain legal proceedings such as bankruptcy proceedings or a cross default to other indebtedness obligations of the Company in excess of $500,000, or a stop order is issued with respect to our common stock. Upon the occurrence of an event of default and following any applicable cure periods, if any, Hercules may take certain actions as set forth in the Hercules Loan Agreement, including declaring all outstanding obligations immediately due and payable. If Hercules exercises this right, we may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time any such event of default occurs. Hercules could also exercise its rights as collateral agent to take possession and dispose of the collateral securing the loan for its benefit, which collateral includes all of our property other than our intellectual property. Our business, financial condition and results of operations could be materially adversely affected as a result of any of these events.

There is no guarantee that healthcare providers and patients will adopt our or our partners’ products or continue to use or prescribe our or our partners’ products, or that we and our partners will be able to receive and maintain adequate payer coverage and reimbursement.

Successful sales of our products depend on the continued prescription by healthcare providers, adoption by patients, and the availability of adequate coverage and reimbursement from third-party payers. There is no guarantee that healthcare and patients’ providers will adopt any newly approved products or continue to prescribe and use products, or that insurers and governmental healthcare programs, such as Medicare and Medicaid, will provide adequate coverage and reimbursement, or will not disadvantage our products through imposition of prior authorization, step therapy, high co-payments, or similar formulary management techniques. For instance, coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Additionally, certain third-party payers restrict or block access to patients for new products until a clinical review has occurred or clinical evidence is provided to support the benefits for covered patients. Many states also use formularies and preferred drug lists to obtain supplemental Medicaid rebates in excess of those required for Medicaid coverage. The industry competition to be included in such formularies and not disadvantaged often leads to downward pricing pressures on pharmaceutical companies. Any labeled limitations on the use of a product or warnings could discourage adoption of the product by patients, healthcare providers, and insurers.

To ensure sales, manufacturers often must provide multiple discounts on the same drug in the chain of distribution to the healthcare provider and the payer. Further, manufacturers are required to assume responsibility for Medicare Part D prescription costs for innovator drugs and biologics and authorized generics while the beneficiary is in the coverage gap. Increasingly, payers are looking for metrics and performance-based pricing to justify increased costs of therapeutic advancements. Even if coverage is 39

31Table of Contents

~~obtained~~governmental healthcare programs, ~~the~~such ~~net~~as ~~realization~~Medicare ~~from~~and ~~price~~Medicaid, ~~concessions~~will ~~may~~provide ~~negatively~~adequate ~~impact~~coverage ~~our~~and ~~profitability. Government~~reimbursement, ~~health~~or ~~programs~~will ~~also~~not ~~impose~~disadvantage ~~inflation~~our ~~penalties~~products ~~that~~through ~~may~~imposition ~~have~~of ~~adverse~~prior ~~consequences~~authorization, ifstep wetherapy, ~~increase~~high ~~prices~~co-payments, inor ~~the~~similar ~~future~~formulary management techniques. For ~~Moreover~~instance, wecoverage ~~and~~decisions ~~our~~may ~~partners~~depend ~~may~~upon ~~experience~~clinical aand ~~delay~~economic instandards ~~receiving~~that ~~coverage~~disfavor ~~and~~new ~~reimbursement~~drug ~~for~~products ~~any~~when ~~new~~more ~~products~~established or ~~may~~lower ~~not~~cost ~~receive~~therapeutic ~~adequate~~alternatives ~~levels~~are ofalready ~~coverage~~available or ~~reimbursement~~subsequently atbecome ~~all~~available. Additionally, Bycertain ~~way~~third-party ofpayers ~~example,~~restrict ~~while~~or weblock ~~have~~access ~~obtained~~to ~~significant~~patients ~~payer~~for ~~coverage~~new ~~for~~products ~~our~~until ~~testosterone~~a ~~replacement~~clinical ~~treatment~~review ~~product,~~has ~~XYOSTED®,~~occurred ~~there~~or isclinical noevidence ~~assurance~~is ~~that~~provided weto ~~will~~support ~~maintain~~the ~~coverage~~benefits ~~with~~for ~~payers~~covered orpatients. ~~remain~~Many atstates ~~the~~also ~~same~~use ~~coverage~~formularies ~~level~~and ~~with~~preferred ~~existing~~drug ~~payers~~lists into ~~future~~obtain ~~periods. New~~supplemental ~~competitive~~Medicaid ~~products~~rebates ~~may~~in beexcess ~~approved~~of ~~and~~those ~~payers~~required ~~may~~for ~~disadvantage~~Medicaid ~~our~~coverage. The ~~products~~industry incompetition ~~favor~~to ofbe ~~the~~included ~~newly~~in ~~approved~~such ~~products~~formularies and ~~technologies.~~not Ifdisadvantaged ~~the~~often ~~time~~leads to ~~obtain~~downward ~~coverage~~pricing ispressures ~~lengthy,~~on ifpharmaceutical wecompanies. ~~are~~Any ~~unable~~labeled tolimitations ~~obtain~~on orthe ~~maintain~~use ~~adequate~~of ~~coverage,~~a product or ifwarnings ~~the~~could ~~rebates~~discourage weadoption ~~negotiate~~of ~~are~~the ~~higher~~product ~~than~~by ~~anticipated~~patients, ithealthcare ~~may~~providers, ~~negatively~~and ~~impact our revenue from product sales~~insurers.

~~Additionally~~To ensure sales, ifmanufacturers ~~healthcare~~often ~~providers~~must ~~and~~provide ~~patients~~multiple dodiscounts ~~not~~on ~~adopt~~the ~~any~~same ~~new~~drug ~~product~~in the chain of distribution to the healthcare provider and the payer. Further, ormanufacturers ifare ~~insurers~~required ~~restrict~~to ~~patient~~assume ~~access~~responsibility orfor ~~disadvantage~~a ~~our~~percentage orof ~~our~~Medicare ~~partners’~~Part ~~products~~D inprescription ~~their~~costs ~~formularies~~for orinnovator ~~otherwise~~drugs doand ~~not~~biologics ~~provide~~while ~~adequate~~the beneficiary is in the coverage ~~and~~gap. ~~reimbursement~~Increasingly, wepayers ~~and~~are ~~our~~looking ~~partners~~for ~~may~~metrics ~~not~~and beperformance-based ~~able~~pricing to ~~generate~~justify ~~sustainable~~increased ~~revenue~~costs ~~growth~~of therapeutic advancements. Even if coverage is obtained, the net realization from ~~product~~price ~~sales~~concessions ~~and~~may ~~royalties~~negatively ~~which~~impact ~~will~~our ~~have~~profitability. Government ahealth ~~material~~programs also impose inflation penalties that may have adverse ~~effect~~consequences onif ~~our~~we ~~business~~increase ~~and~~prices ~~future~~in ~~product~~the ~~opportunities~~future. Moreover, Wewe and our partners, ~~accordingly,~~ may ~~need~~experience toa ~~take~~delay ~~steps~~in toreceiving ~~assist~~coverage ~~patients~~and inreimbursement ~~their~~for ~~ability~~any tonew ~~afford our~~ products, ~~such~~or asmay ~~offering~~not ~~bridge~~receive ~~programs,~~adequate ~~free-trials,~~levels ~~discounts,~~of ~~rebates~~coverage ~~and~~or ~~co-pay~~reimbursement ~~coupon~~at ~~programs~~all. AsNew ancompetitive ~~example,~~products wemay ~~currently~~be ~~offer~~approved, ~~co-pay~~and ~~assistance~~payers tomay ~~eligible~~disadvantage ~~patients~~our ~~designed~~products toin ~~help~~favor ~~off-set~~of the ~~amount~~newly ofapproved aproducts ~~patient’s~~and ~~co-pay~~technologies. ~~insurance~~If ~~for~~the ~~XYOSTED®~~time to obtain coverage is lengthy, ~~OTREXUP®~~if ~~and~~we ~~NOCDURNA®. These~~are ~~programs~~unable to obtain or maintain adequate coverage, or ~~however~~if the rebates we negotiate are higher than anticipated, it may ~~not~~negatively ~~ultimately~~impact beour ~~successful~~revenue from product sales.

Additionally, if healthcare providers and patients do not adopt any new product, or if insurers restrict patient access or disadvantage our or our partners’ products in their formularies or otherwise do not provide adequate coverage and reimbursement, we and our partners may not be able to generate sustainable revenue growth from product sales and royalties which will have a material adverse effect on our business and future product opportunities. We and our partners, accordingly, may need to take steps to assist patients in their ability to afford our products, such as offering bridge programs, free-trials, discounts, rebates and co-pay coupon programs.

New information concerning our or our partners’ products learned through required post-approval studies and product use may also result in changes to our or our partners’ products. Should any of these events occur, they could have a material and adverse effect on our operations and business.

Any post-approval requirements, including ~~phase~~Phase IV studies may also require the dedication of substantial time and resources. By example, as a post-marketing requirement for XYOSTED®, we must conduct a pediatric study. ~~and~~The ~~the~~ FDA has also asked us to conduct a separate label comprehension study that assesses patients’ understanding of key risk messages in the Medication Guide for XYOSTED® and a study of testosterone replacement therapy in pediatric males ages 14 years and older for conditions associated with a deficiency or absence of endogenous testosterone. The label comprehension study findings may result in revisions to the Medication Guide to optimize patients’ understanding of important risks of XYOSTED® and potentially other label restrictions or changes. The FDA found that our first label comprehension study did not fulfill the post approval requirement and, thus, we are preparing to conduct a new label comprehension study, which must be completed by the ~~end~~middle of ~~2026~~2023 and will require dedication of funds and resources. Additionally, the outcome of any post-approval studies, including the pediatric study, is uncertain and may not result in an expanded label indication or could result in additional labeling requirements or other post-approval restrictions or regulatory actions.

Additionally, use of our or our partners’ products by patients and in ~~phase~~Phase IV and post-marketing studies may result in the discovery of new information concerning the products. This may result in regulatory or other actions, including, product liability actions, enforcement actions, distribution and manufacturing restrictions, changes to product labeling and promotional materials, the imposition of post-market requirements, such as REMS or additional ~~phase~~Phase IV studies, withdrawal of marketing application approvals, withdrawal of the product from the market, refusal to approve new marketing applications or supplements, product recalls, clinical holds and suspension of clinical studies, safety alerts, dear healthcare provider letters, adverse publicity, and reimbursement and insurance coverage consequences, among others. Should any of these events occur, they could have a material and adverse effect on our operations and business. By way of example, in October 2020 the FDA proposed that Makena® be withdrawn from the market following a review by the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee. ~~AMAG~~Covis subsequently requested an FDA public hearing, and the FDA has granted the request. The FDA has not yet set a date for the public hearing. While, at this time, Makena® may still be marketed, we do not yet know what the FDA’s ultimate decision will be and whether ~~AMAG will decrease the~~ resources that it ~~dedicates~~dedicated to Makena® will be reduced. The uncertainty with ~~regard to Makena® has negatively impacted our product revenue and royalties from AMAG and may adversely impact the business.~~

Table of Contents

regard to Makena® has negatively impacted our product revenue and royalties from Covis and may adversely impact the business.

Our employees, independent contractors, consultants, commercial partners, manufacturers, principal investigators, or contract research organizations (“CROs”) may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees, independent contractors, consultants, commercial partners, manufacturers, investigators or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, comply with federal procurement rules or contract terms, report financial information or data accurately or disclose unauthorized activities to us. This misconduct could also involve the improper use or misrepresentation of information obtained induring ~~the course of~~ clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter this type of misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to becomply ~~in compliance~~ with such laws or regulations. Moreover, it is possible for a whistleblower to pursue a False Claims Act (“FCA”) case against us based on the actions or inactions of these third parties even if the government considers the claim unmeritorious and declines to intervene, which could require us to incur costs defending against such a claim. Further, due to the risk that a judgment in an FCA case could result in exclusion from federal health programs or debarment from procurement programs, whistleblower cases often result in large settlements. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, and results of operations, including the imposition of significant fines or other sanctions.

32We rely on third parties to perform many necessary services for our products including services related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, storage and transportation of our products.

~~defending~~Depending ~~against~~on ~~such~~the product, we have retained third-party service providers to perform a ~~claim.~~variety ~~Further,~~of ~~due~~functions related to the ~~risk~~distribution, ~~that~~invoicing, arebates ~~judgment~~and incontract anadministration, ~~FCA~~co-pay ~~case~~program ~~could~~administration, ~~result~~sample indistribution ~~exclusion~~and ~~from~~administration, ~~federal~~storage ~~health~~and ~~programs~~transportation orof ~~debarment~~our ~~from~~products, ~~government~~key ~~contracts,~~aspects ~~whistleblower~~of ~~cases~~which ~~often~~are ~~result~~out inof ~~large~~our ~~settlements~~direct control. IfWe ~~any~~place ~~such~~substantial ~~actions~~reliance ~~are~~on ~~instituted~~these ~~against~~providers as well as other third-party providers that perform services for us, including, depending on the product, entrusting our inventories of products to their care and handling. We also may rely on third parties to administer our drug price reporting and rebate payments and contracting obligations under federal programs. Despite our reliance on third parties, we are ~~not~~responsible ~~successful~~for compliance with the applicable legal and program requirements. By example, in ~~defending~~certain ~~ourselves~~states, orwe ~~asserting~~are required to hold licenses to distribute our ~~rights~~products in these states and must comply with the associated state laws. Moreover, ~~those~~if ~~actions~~these ~~could~~third-party ~~have~~service providers fail to meet expected deadlines, or otherwise do not carry out their contractual duties to us or encounter physical damage or a ~~significant~~natural ~~impact~~disaster onat their facilities, our ~~business~~ability to deliver products to meet commercial demand would be significantly impaired. In addition, ~~financial~~we ~~condition~~may use third parties to perform various other services for us relating to regulatory monitoring, including adverse event reporting, safety database management and ~~results~~other ofproduct ~~operations~~maintenance services. If our employees or any third-party service providers fail to comply with applicable laws and regulations, ~~including~~we and/or they may face regulatory or FCA enforcement actions. Moreover, if the ~~imposition~~quality or accuracy of ~~significant~~the ~~fines~~data maintained by these service providers is insufficient, our ability to continue to market our products could be jeopardized or ~~other~~we and/or they could be subject to regulatory sanctions. We do not currently have the internal capacity to perform these important commercial functions, and we may not be able to maintain commercial arrangements for these services on reasonable terms.

We rely on third parties to perform many necessary services for XYOSTED®, OTREXUP® and NOCDURNA® including services related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, storage and transportation of our products.

We have retained third-party service providers, including Cardinal, to perform a variety of functions related to the distribution, invoicing, rebates and contract administration, co-pay program administration, sample distribution and administration, storage and transportation of our products, key aspects of which are out of our direct control. We place substantial reliance on this provider as well as other third-party providers that perform services for us, including entrusting our inventories of products to their care and handling. We also rely on third parties to administer our drug price reporting and rebate payments and contracting obligations under federal programs. Despite our reliance on third parties, we are responsible for compliance with the applicable legal and program requirements. By example, in certain states, we are required to hold licenses to distribute our products in the states and must comply with the associated state laws. Moreover, if these third-party service providers fail to meet expected deadlines, or otherwise do not carry out their contractual duties to us or encounter physical damage or a natural disaster at their facilities, our ability to deliver products to meet commercial demand would be significantly impaired. In addition, we use third parties to perform various other services for us relating to regulatory monitoring, including adverse event reporting, safety database management and other product maintenance services. If our employees or any third-party service providers fail to comply with applicable laws and regulations, we and/or they may face regulatory or FCA enforcement actions. Moreover, if the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market our products could be jeopardized or we and/or they could be subject to regulatory sanctions. We do not currently have the internal capacity to perform these important commercial functions, and we may not be able to maintain commercial arrangements for these services on reasonable terms.

We are dependent on numerous third parties in our supply chain for the supply and manufacture of our products and our partners’ products. If we do not develop and maintain relationships with suppliers, manufacturers, assemblers and/or licensees of our and our partners’ drug/device products or product candidates, or if such third parties are unable to supply or manufacture products or assemble and package the final products, we may be unable to successfully manufacture, assemble, package and sell our and our partners’ products, which could have a material adverse effect on our business.

The availability of our products and product candidates depends upon our ability to procure the raw materials, components, packaging materials and finished products that we need from third parties. We have entered into supply agreements with numerous third-party suppliers, many of which are currently our single source for the materials necessary for certain of our products. If any of these or other third parties are unable to supply their respective components for any reason, including due to violations of the FDA’s QSR or cGMP requirements, our or our partners’ ability to manufacture the finished product will be adversely affected and our ability to meet the supply and demand for any sales of such products and the resulting revenue therefrom will be negatively affected. Additionally, as many of our components are manufactured by sole third-party suppliers, in the event of a failure to supply, we may not be able to find alternative third suppliers in a timely or cost-effective manner. Moreover, any failure to comply with the applicable regulatory requirements could subject us, our suppliers, or our collaborators to regulatory enforcement actions or recalls. In the case of product candidates, our and our partners’ ability to conduct the necessary studies would also be adversely impacted.

We do not currently utilize our own facilities to manufacture commercial quantities of our or our partners’ drug/device combination products or components, including but not limited to XYOSTED®, OTREXUP®, Sumatriptan Injection USP, epinephrine auto-injector devices, Makena® auto injectors or any other of our or our partners’ products or product candidates. We also do not possess the facilities to manufacture clinical supplies of any product candidates or components. We must contract with third parties and/or our partners to produce products, components, and product candidates and to assemble and package finished products and related components according to specifications and that must comply with all applicable manufacturing requirements, including cGMPs for drug products and QSRs for medical devices. The future development and delivery of our and our partners’ products and product candidates depend on the capability, as well as the timely, profitable and competitive performance of these third parties and/or our partners, in addition to their initial and continued FDA approval following regulatory authority facility inspections and compliance. There is also no assurance that such third parties and/or our partners will be willing to manufacture, assemble or sell the drug/device products or components or that they will not encounter manufacturing delays, problems, or difficulties. A limited number of manufacturers exist that are capable of manufacturing our and our partners’ products, components, and product candidates. We and our partners may fail to contract with the necessary third parties or we and our partners may contract with third parties on terms that may not be favorable to us. By example, the cost of manufacturing may be impacted in the future by a number of different factors, including, but not limited to, changes in law, as well as global trade policies.41

InTable addition, contract manufacturers may use their own technology, technology developed by us, technology developed by our partners, or technology acquired or licensed from third parties. When contract manufacturers develop proprietary process technology, our reliance on such contract manufacturers is increased. A technology transfer from the original contract manufacturer may be required. Any such technology transfer may also require the transfer of ~~requisite data for regulatory purposes, including information~~ Contents

33Moreover, any failure to comply with the applicable regulatory requirements could subject us, our suppliers, or our collaborators to regulatory enforcement actions or recalls. In the case of product candidates, our and our partners’ ability to conduct the necessary studies would also be adversely impacted.

~~contained~~We indo anot ~~proprietary~~currently ~~drug~~use our own facilities to manufacture commercial quantities of our or our partners’ drug/device ~~master~~combination ~~file~~products ~~held~~or bycomponents. aWe currently must contract ~~manufacturer.~~with Wethird parties and/or our partners ~~would~~to beproduce ~~dependent~~products, oncomponents, ~~the~~and ~~contract~~product ~~manufacturer~~candidates ~~for~~and ~~the~~to ~~maintenance~~assemble and ~~right~~package offinished ~~reference~~products and related components according to ~~the~~specifications ~~drug~~and orthat ~~device~~must ~~master~~comply ~~file. If~~with ~~the~~all ~~contract~~applicable ~~manufacturer~~manufacturing ~~fails~~requirements, toincluding ~~maintain~~cGMPs afor drug orproducts ~~device~~and ~~master~~QSRs ~~file~~for ormedical ~~withdraws~~devices. The future development and delivery of our orand our partners’ ~~right~~products ofand ~~reference~~product candidates depend on the capability, weas well as the timely, profitable and competitive performance of these third parties and/or our partners, ~~may~~in addition to their initial and continued FDA approval following regulatory authority facility inspections and compliance. There is also no ~~longer~~assurance that such third parties and/or our partners will be ~~able~~willing to manufacture, ~~develop~~assemble or sell the drug/device products or components or that they will not encounter manufacturing delays, ~~market~~problems, ~~and~~or ~~sell~~difficulties. A limited number of manufacturers exist that can manufacture our orand our partners’ products, orcomponents, and product candidates.

WeIn ~~rely~~addition, oncontract ~~multiple~~manufacturers ~~commercial~~may ~~supply~~use ~~arrangements~~their ~~with~~own ~~third-party manufacturers for~~technology, ~~including,~~technology ~~without~~developed ~~limitation:~~by ~~the~~us, ~~production~~technology ~~and~~developed ~~supply~~by ofour ~~the methotrexate~~partners, ~~sumatriptan~~or ~~and~~technology ~~testosterone~~acquired ~~drug~~or ~~substance~~licensed infrom ~~pre-filled~~third ~~syringes;~~parties. ~~the~~When ~~manufacture~~contract ofmanufacturers ~~prefilled~~develop ~~syringes;~~proprietary ~~the~~process ~~manufacture~~technology, ofour ~~device~~reliance ~~components;~~on ~~the~~such ~~manufacture~~contract ~~and~~manufacturers ~~partial~~is ~~assembly~~increased. ofA ~~VIBEX®~~technology ~~and~~transfer ~~Quickshot~~from ~~auto injectors; and~~ the ~~final~~original ~~assembly~~contract ~~and~~manufacturer ~~packaging~~may ofbe ~~our~~required. ~~products~~Any ~~and~~such ~~product~~technology ~~candidates~~transfer ~~and~~may ~~our~~also ~~partners’~~require ~~products~~the ~~and~~transfer ~~product~~of ~~candidates.~~requisite ~~Our~~data ~~third-party~~for ~~manufacturers~~regulatory ~~may~~purposes, ~~also~~including ~~fail~~information tocontained ~~pass~~in ~~the~~a ~~audits~~proprietary bydrug ~~our~~ or ~~our~~device ~~partners’~~master ~~internal~~file ~~quality~~held ~~and~~by ~~regulatory~~a ~~group~~contract manufacturer. ~~Any~~ ofWe ~~these actions could delay~~ and/or ~~prevent~~ our ~~development~~partners ofwould ~~products,~~be ~~delay~~dependent oron ~~prevent~~ the ~~submission~~contract ofmanufacturer ~~these~~for ~~products~~the ~~for~~maintenance ~~regulatory~~and ~~approval,~~right ~~delay~~of orreference ~~prevent~~to ~~marketing~~the ~~approval,~~drug or ~~result~~device inmaster ~~insufficient~~file. If ~~product~~the orcontract ~~product~~manufacturer ~~candidate~~fails ~~quantity~~ to ~~support~~maintain ~~commercial~~a ~~demand~~drug or ~~development. We~~device ~~may~~master ~~also~~file beor ~~required~~withdraws toour ~~replace~~or ~~manufacturers,~~our ~~which~~partners’ ~~would~~right beof ~~time~~reference, ~~consuming~~we and/or ~~expensive,~~our ~~and~~partners we may ~~not~~no longer be able to ~~reach~~manufacture, ~~favorable agreements with or FDA approval for alternative manufacturers. As a result~~develop, ~~our business~~market, ~~financial condition~~ and ~~results~~sell ofour ~~operations~~or ~~could~~our bepartners’ ~~seriously~~products ~~harmed.~~or ~~See~~product ~~additional risk factors associated with manufacturing in the section “Risks Related to Regulatory Matters~~candidates.”

We ~~depend~~rely on ~~Teva~~multiple commercial supply arrangements with third-party manufacturers. Our third-party manufacturers may fail to ~~manufacture~~pass the ~~drug~~audits by our or our partners’ internal quality and ~~finished~~regulatory ~~packaged~~group. Any of these actions could delay or prevent our development of products, delay or prevent the submission of these products for regulatory approval, delay or prevent marketing approval, or result in insufficient product ~~and~~or product candidate quantity to ~~distribute~~support commercial demand or development. We may also be required to replace manufacturers, which would be time consuming and ~~commercialize~~expensive, ~~the~~and ~~epinephrine~~we ~~auto-injector~~may innot ~~the~~be ~~United~~able ~~States~~to reach favorable agreements with or FDA approval for alternative manufacturers. As a result, our business, financial condition and results of operations could be seriously harmed.

WeIn ~~have~~addition ~~entered~~to ~~into~~the aabove ~~license,~~manufacturing ~~development~~capabilities ~~and~~provided ~~supply~~by ~~agreement~~third ~~with~~party ~~Teva~~manufacturers, ~~pursuant~~on toJuly ~~which~~1, 2019, we ~~developed~~entered ~~and~~into ~~are~~a ~~the~~lease ~~exclusive~~for ~~supplier~~office, oflaboratory, ~~the~~manufacturing ~~device~~and ~~for~~warehousing anspace ~~epinephrine~~in ~~auto~~Minnetonka, ~~injector~~Minnesota. ~~product~~We ~~marketed~~completed bythe ~~Teva~~build-out inof the ~~United~~facility ~~States.~~and ~~There~~began isoccupying nothe ~~guarantee~~space ~~that~~in ~~our~~2020. ~~partnership~~The ~~with~~new ~~Teva~~facility ~~will~~supports beour ~~successful. Teva~~administrative ~~controls~~functions, ~~the~~product ~~manufacture~~development and ~~supply~~quality ~~of the drug~~operations, ~~epinephrine,~~ and ~~the~~is ~~final~~intended ~~assembly~~to ofprovide ~~the~~additional ~~devices~~manufacturing and ~~packaging~~warehousing ofcapabilities in the ~~finished~~future. ~~product~~If ~~and~~we ~~has~~begin ~~complete~~manufacturing ~~control~~or ~~over~~producing commercial products in the ~~commercialization~~future, ~~and~~we ~~sale~~will ofbe subject to the ~~epinephrine~~same ~~auto~~risks ~~injector~~as ~~product~~our third-party manufacturers. ~~If,~~We atmay ~~any~~also ~~time,~~not ~~Teva~~be ~~ceases~~able to ~~manufacture~~begin product manufacturing and ~~supply~~production ~~the~~in ~~epinephrine~~a ~~drug~~timely ormanner ~~fails~~due to ~~produce~~a ~~sufficient~~number ~~supplies~~ of ~~the~~different ~~drug~~reasons, ~~Teva~~including, ~~will~~but benot ~~unable~~limited, an inability to ~~produce~~obtain athe ~~finished~~necessary ~~product~~supplies, labor and weexpertise. We may also be ~~unable~~delayed toif ~~sell~~we ~~our~~are ~~auto~~not ~~injectors~~able ~~for~~to ~~this~~obtain ~~product~~necessary tolicensing ~~Teva~~and ~~resulting~~regulatory authority inspections in ~~less~~a ~~revenue~~timely ~~for~~manner, ussuch as due to inspection restrictions during the Pandemic. Any failure to commence operations at our own facilities could have a material impact on our business.

InSome ~~addition, if Teva is unable to complete the final assembly and packaging~~ of ~~the~~our ~~finished~~suppliers ~~epinephrine auto injector product, we~~ may ~~receive~~experience ~~less~~disruption ~~revenue~~to ~~than~~their ~~desired~~respective orsupply ~~expected. If~~chains ~~Teva~~due ~~is unable~~ to ~~produce~~the ~~sufficient~~effects ~~supplies~~ of the ~~drug~~COVID-19 orpandemic ~~finished epinephrine auto injector product in accordance with the applicable manufacturing requirements or otherwise fails to comply with applicable regulatory requirements~~(“Pandemic”), ~~Teva may be subject to regulatory enforcement action,~~ which could ~~impact its ability to produce~~delay, ~~market,~~prevent ~~commercialize,~~or ~~sell,~~impair ~~and distribute the finished drug product, and in turn,~~ our ~~revenue.~~development We rely on Teva to commercialize and distribute the product, including determining the price and payer coverage. If Teva is unsuccessful in commercializing the product, the resulting revenue may be lower than expected. Additionally, Teva controls the business strategy, manufacturing and distribution decisions concerning the epinephrine auto injector product. Such decisions by Teva may be beyond our control and may impact the success of the epinephrine auto injector product. As a result, we may receive less revenue than desired or ~~expected.~~commercialization Further, Teva is subject to potential competition regarding other generic versions of the epinephrine auto injector product, and such additional competition could result in receiving less revenue than expectedefforts.

We ~~depend~~obtain oncertain ~~Teva~~critical materials and components used in manufacturing our products from third-party suppliers whose operations may be directly or indirectly affected by the Pandemic. If we are unable to ~~manufacture~~obtain these critical materials and components in sufficient quantities and in a timely manner, our supply ~~the~~of ~~drug~~product for ~~VIBEX®~~commercialization ~~Sumatriptan~~may be disrupted or delayed which could have a material impact on our revenue and tothe ~~distribute~~development, testing and ~~commercialize~~clinical ~~the~~study of our products and product incandidates ~~the~~might ~~United~~be ~~States~~delayed or infeasible, and regulatory approval or commercialization of our products and product candidates might be delayed, not obtained or hindered, which could significantly harm our business.

WeSee ~~have~~additional ~~entered~~risk ~~into~~factors aassociated ~~license, supply and distribution agreement~~ with ~~Teva~~manufacturing to distribute VIBEX® Sumatriptan, an auto injector product containing sumatriptan for the treatment of migraines. Under our arrangement, we will manufacture the auto injector and are responsible for final assembly and packaging of the final product and Teva will manufacture and supply the drug sumatriptan and distribute and commercialize the product in the ~~United~~section ~~States.~~“Risks ~~Teva~~Related ~~also~~to ~~has~~Regulatory ~~an option for rights in other territories~~Matters. ”

There is no guarantee that our partnership with Teva to distribute VIBEX® Sumatriptan will be successful. Teva controls the manufacture and supply of the drug, sumatriptan, which is necessary for the production of VIBEX® Sumatriptan. If, at any time, Teva ceases to manufacture and supply us with sumatriptan or fails to produce sufficient supplies of the drug, we will be unable to produce a finished product or sell our auto injectors designed for this product to Teva. In addition, if Teva is not able to produce sufficient supplies of the drug in accordance with cGMPs, we also will be unable to produce a finished product and we and/or Teva may be subject to regulatory enforcement action. We also rely on Teva to commercialize and distribute the product within the U.S. and if Teva is unsuccessful in commercializing the product, the resulting revenue may be lower than expected. Moreover, because we hold the FDA approved application for this product, we are responsible for FDA regulatory compliance. Should Teva fail to comply with the applicable regulatory requirements, Teva or we may be subject to regulatory enforcement action. Any enforcement action could impact the ability to produce, market, commercialize, sell, and distribute the finished drug product, and in turn, our revenue. Additionally, we may disagree with Teva on certain business strategies or its manufacturing and distribution decisions. Such decisions by Teva may be beyond our control and may impact the success of VIBEX® Sumatriptan and we may receive less revenue than desired or expected. We have invested significant resources in the development of VIBEX® Sumatriptan, and, if our partnership with Teva is not profitable or is terminated for any reason, we may not receive a return on our investment and may suffer significant losses. 42

34Table of Contents

We ~~depend~~rely on ~~AMAG~~many of our partners to manufacture and supply the ~~progestin hormone~~ drug ~~Makena®,~~for totheir ~~distribute and commercialize the combination~~ product ~~that incorporates a variation of our VIBEX® QuickShot® subcutaneous auto injector for use with drug,~~ and to ~~maintain~~distribute ~~regulatory~~and ~~approval~~commercialize oftheir ~~the product~~products.

We have entered into a license, ~~development~~ and supply ~~agreement~~agreements with ~~AMAG~~several todifferent ~~distribute~~partners. aUnder ~~variation~~many of ~~our~~the ~~VIBEX®~~arrangements, ~~QuickShot®~~our ~~subcutaneous~~partners ~~auto~~are ~~injector~~responsible for ~~use~~supplying ~~with~~the ~~AMAG’s progestin hormone~~ drug ~~Makena®,~~product ~~the~~and ~~Makena®~~we ~~Auto~~are ~~Injector.~~responsible ~~Makena®~~for ~~was~~manufacturing ~~first approved by~~ the ~~FDA~~auto ~~via~~injector ~~the~~and ~~accelerated approval pathway in 2011. There is no guarantee that our partnership with AMAG will be successful, that AMAG will be able to maintain approval~~ for ~~Makena®~~final orassembly ~~that AMAG will be able to successfully manufacture, supply, commercialize,~~ and ~~distribute~~packaging of the final product. ~~The~~Our ~~FDA~~partners isare ~~currently~~responsible ~~seeking~~for ~~withdrawal~~the ofdistribution ~~Makena®. For more information regarding Makena®~~ and ~~AMAG,~~commercialization ~~see~~of ~~additional~~the ~~risk factors associated with information concerning our or our partners’~~ products in ~~this~~the ~~section~~U.S.

~~Additionally,~~There ~~AMAG~~is ~~controls~~no ~~the~~guarantee ~~manufacture~~that ~~and~~our ~~supply~~arrangements with any of ~~the~~our ~~drug,~~partners ~~hydroxyprogesterone~~will ~~caproate,~~be ~~and~~successful. ~~has~~Our ~~complete~~partners typically control ~~over~~ the ~~launch~~manufacture and ~~continuous~~supply ~~commercialization~~of ~~and~~the ~~marketing~~drug offor ~~Makena®~~their ~~Auto~~auto-injector ~~Injector worldwide~~product. If, at any time, ~~AMAG~~our partner is unable to source their drug or ceases to manufacture and supply us with ~~hydroxyprogesterone~~their ~~caproate~~drug or fails to produce sufficient supplies of the drug, we ~~will~~may be unable to produce a finished product or sell our auto injectors designed for ~~this~~their product ~~to AMAG~~. In addition, if ~~AMAG~~any isof ~~unable~~our partners are not able to produce sufficient supplies of the drug in accordance with cGMPs ~~or otherwise fails to comply with the applicable regulatory requirements~~, we also will be unable to produce a finished product and~~/or~~ we and/or ~~AMAG~~our partner may be subject to regulatory enforcement action,. ~~which~~We ~~would~~also ~~impact~~rely ~~the~~on ~~ability~~our partners to ~~produce, market,~~ commercialize, ~~sell,~~ and distribute ~~the~~their ~~finished~~product ~~drug~~within ~~product,~~the U.S. and, if they are unsuccessful in ~~turn~~commercializing the product, ~~impact~~the ~~our~~resulting revenue. Wemay ~~rely~~be onlower ~~AMAG~~than toexpected. ~~commercialize~~In ~~and~~many ~~distribute~~instances, our partners hold the ~~product~~marketing ~~worldwide~~authorization for their products and ifshould ~~AMAG~~our ispartner ~~unsuccessful~~fail into ~~commercializing~~comply with the ~~product~~applicable regulatory requirements, ~~the~~our ~~resulting~~partner ~~revenue~~or we may be ~~lower~~subject ~~than~~to ~~expected~~regulatory enforcement action. ~~Additionally~~There may be instances in which we hold the marketing authorization of the product, and therefore, we may ~~disagree~~face greater risk of regulatory enforcement should any of our partners fail to comply with ~~AMAG~~the onapplicable ~~certain~~regulatory ~~business~~requirements. ~~strategies~~Any orenforcement ~~its~~action ~~manufacturing~~could impact the ability to produce, market, commercialize, sell, and ~~distribution~~distribute ~~decisions. Such~~the ~~decisions~~finished bydrug ~~AMAG~~product, ~~may~~and bein ~~beyond~~turn, our revenue. Additionally, our partners’ control the distribution and commercialization strategies for their products and we may disagree with their decision or business strategies. Such decisions may impact the success of ~~the~~their ~~Makena®~~product ~~Auto~~commercialization, ~~Injector~~ and we may receive less revenue than desired or expected. Also, as our partners are subject to the same product development and commercialization risks as us, any adverse impact on our partners could have an adverse impact on us.

We and AMAG are subject to competition for generic versions of the intramuscular formulation of Makena®, which is less costly for patients. This competition could result in more patients utilizing the intramuscular formulation rather than the subcutaneous auto injector, thus resulting in us receiving potentially less revenue than expected.

We may incur significant liability if it is determined that we are promoting or have in the past promoted the “off-label” use of drugs or medical devices, or otherwise promoted or marketed approved products in a manner inconsistent with the FDA’s requirements.

In the U.S. and certain other jurisdictions, companies may not promote drugs or medical devices for “off-label” uses, that is, uses that are not described in the product’s labeling and that differ from those that were approved or cleared by the FDA or other foreign regulatory agencies. Under what is known in the C’s as the “practice of medicine,” physicians and other healthcare practitioners may prescribe drug products and use medical devices for off-label or unapproved uses, and such uses are common across some medical specialties. Although the FDA does not regulate a physician’s choice of medications, treatments or product uses, the Federal Food, Drug and Cosmetic Act and FDA regulations significantly restrict permissible communications on the subject of off-label uses of drug products and medical devices by pharmaceutical and medical device companies. As the sponsors of FDA approved products, we and our partners will not only be responsible for the actions of the companies but also can be held liable for the actions of employees and contractors, requiring that all employees and contractors engaging in regulated functions, such as product promotion, be adequately trained and monitored, which requires time and monetary expenditures.

If the FDA determines that a company has improperly promoted a product “off label” or otherwise not in accordance with the agency’s promotional requirements, the FDA may issue a warning letter or seek other enforcement action to limit or restrict certain promotional activities or materials or seek to have product withdrawn from the market or seize product, among other enforcement requirements. In addition, a company that is found to have improperly promoted off-label uses may be subject to significant liability, including civil fines, criminal fines and penalties, civil damages and exclusion from federal funded healthcare programs such as Medicare and Medicaid and/or government contracting, consent decrees and corporate integrity agreements, as well as potential liability under the federal FCA and applicable state false claims acts. Conduct giving rise to such liability could also form the basis for private civil litigation by third-party payers or other persons allegedly harmed by such conduct.

Moreover, in addition to the regulatory restrictions on off-label promotion, there are other FDA restrictions on and requirements concerning product promotion and advertising, such as requirements that such communications be truthful and non-misleading and adequately supported. The FDA also has requirements concerning the distribution of drug samples. The FDA and other authorities may take the position that we are not in compliance with promotional, advertising, and marketing requirements, and, if such non-compliance is proven, we may be subject to significant liability, including but not limited to administrative, civil and criminal penalties and fines, in addition to regulatory enforcement actions.

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We currently depend on a limited number of customers for the majority of our revenue, and the loss of any one of these customers could substantially reduce our revenue and impact our liquidity.

For the year ended December 31, ~~2020~~2021, we derived approximately 4042% of our revenue from Teva. In addition, we derived a significant portion of our product sales revenue from wholesale distributors including McKesson, AmerisourceBergen and Cardinal Health, which each accounted for approximately 1213%, 12% and 11% of total revenues in ~~2020~~the year ended December 31, 2021, respectively. The loss of any of these significant customers or partners or reduction in our business activities could cause our revenues to decrease significantly and ~~increase~~impact our ~~continuing~~income ~~losses~~ from operations. If we do not broaden our customer base, we will continue to depend on these few customers for the majority of our revenues. Additionally, if we are unable to negotiate favorable business terms with these customers in the future, our revenues and gross profits may be insufficient to allow us to achieve and/or sustain profitability or continue operations.

The failure of our licensees to perform under any of our existing licensing agreements or the failure of our licensees/partners to develop and obtain regulatory approval for their product candidates or the failure to enter into new licensing agreements could substantially affect our revenue.

One of our business strategies is to enter into license agreements with pharmaceutical companies covering the development, manufacture, use and marketing of our drug delivery devices with specific drug therapies. Under these arrangements, the partners typically assist us in the development of the product and sponsor the collection of the appropriate data for submission for regulatory approval of the use of the drug delivery device with the licensed drug therapy. Our licensees may also be responsible for distribution and marketing of the product or technologies for these therapies either worldwide or in specific territories. We are currently a party to a number of such agreements, all of which are currently in varying stages of development. We may not be able to meet future milestones established in our agreements (such milestones generally being structured around satisfactory completion of certain phases of clinical development, regulatory approvals and commercialization of our product), and thus would not receive the fees expected from such arrangements, related future royalties or product sales. Moreover, there can be no assurance that we will be successful in executing additional collaborative agreements or that existing or future agreements will result in increased sales of our drug delivery technologies or products. In such event, our business, results of operations and financial condition could be adversely affected, and our revenues and gross profits may be insufficient to allow us to achieve and/or sustain profitability.

As a result of our collaborative agreements, we are dependent upon the development, data collection and marketing efforts of our licensees. The amount and timing of resources such licensees devote to these efforts are not within our control, and such licensees could make material decisions regarding these efforts that could adversely affect our future financial condition and results of operations. If one or more of these pharmaceutical company partners fail to pursue the development or marketing of, or are unable to receive marketing approval for our and our partners’ products as planned, or fail to perform their contractual obligations in accordance with all regulatory requirements, our revenues and profits may not reach expectations or may decline. In addition, factors that adversely impact the introduction and level of sales of any drug or drug device covered by such licensing arrangements, including competition within the pharmaceutical and medical device industries, the timing of regulatory or other approvals and intellectual property litigation, may also negatively affect sales of our drug delivery technology. For instance, competition in this market could also force us or our partners to reduce the prices of our technologies below currently planned levels, which could adversely affect our revenues and future profitability. Moreover, our partners and licensees will be subject to many of the same regulatory risks as we are. To the extent that they are not able to comply with the applicable regulatory requirements, or are not able to obtain or maintain regulatory product approvals, we and they may be subject to regulatory enforcement action, the performance of their obligations under their contracts with us may be inhibited, and we may not be able to realize the benefit of the relationship.

We are relying on partners such as Teva, ~~AMAG~~Covis, Pfizer and Idorsia for future milestone, sales and royalty revenue. Our partners may fail to obtain FDA or foreign approvals of a product with our technologies or may be unsuccessful in commercializing a product. There is no assurance that development of our partners’ products will continue or that they will ultimately receive FDA approval in a timely manner or at all, or if FDA approved, they will be a significant revenue source for us. Significant delays in anticipated launches of these products in development may occur. While we assist our partners in some cases in obtaining regulatory approvals and advancing new products, we depend on these partners and cannot control their decision-making or progress in achieving such goals. Any potential loss of anticipated future revenue could have an adverse effect on our business and the value of your investment.

An increase in the number of competitors targeting generic and 505(b)(2) ANDA opportunities and seeking U.S. market exclusivity may adversely affect our revenues and profits.

Our ability to achieve continued growth and profitability through sales of pharmaceuticals is dependent on our and our partners’ continued success in challenging patents, developing non-infringing products or developing products with ~~increased~~improved complexity to provide opportunities with U.S. market exclusivity or limited competition. There is substantial competition in the pharmaceutical industry. We and our partners will face competition from generic drug productsefficacy, drug products that are similar to our or our partners’ products, drug products containing the same active ingredient as our or our partners’ products, and drug products for the same indication as our or our partners’ products.

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~~Our~~Table ~~or our partners’ products may be eligible for periods~~ of regulatory exclusivity, as described elsewhere in this annual report. This exclusivity, however, may not adequately protect our or our partners’ products from competition. If any periods of exclusivity that we or our partners may have do not adequately protect the applicable product or if we or they do not receive or lose anticipated periods of regulatory exclusivity, we or they may be subject to abbreviated new drug application (“ANDA”) and/or 505(b)(2) competition sooner than we anticipate. We or our partners may also be subject to increased generic competition sooner than anticipated as the FDA, Congress, and the Administration have taken steps to facilitate the approval of generic products and increase competition in the prescription drug market. New legislative and regulatory efforts could ultimately have an adverse impact on our business and results of operation.Contents

~~Further,~~safety ~~regardless of any granted exclusivities, we~~ or ~~our~~usability ~~partners~~to ~~may~~provide ~~face~~opportunities ~~competition~~with ~~from~~U.S. ~~products~~market orexclusivity ~~product uses that are not otherwise blocked by our~~ or ~~our~~limited ~~partners’ patents or exclusivities~~competition. ~~For~~There ~~example, exclusivity does not prevent physicians from prescribing a similar product even if it~~ is ~~not~~substantial ~~approved~~competition ~~for the same indication. By further example,~~ in ~~2019,~~ the ~~FDA~~pharmaceutical ~~approved Clarus Therapeutic, Inc~~industry.’s We ~~product,~~and ~~Jatenzo®,~~our anpartners ~~oral~~will ~~testosterone~~face ~~undecanoate~~competition ~~capsule~~from ~~for~~generic ~~testosterone~~drug ~~replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The introduction of Jatenzo®~~products, ~~which~~drug ~~was launched for commercial sale in February 2020, and other oral or competing testosterone~~ products ~~may~~that ~~materially~~are ~~impact~~similar to our ~~sales of XYOSTED®. Moreover, we~~ or our partners’ ~~may~~products, ~~face~~drug ~~competition from other~~ products ~~intended~~containing ~~for~~ the same ~~use and/or that otherwise contain the same~~ active ~~ingredients,~~ingredient ~~which~~as ~~may be less expensive than~~ our or our partners’ products~~. Any~~, ~~increase~~and ordrug ~~changes~~products infor the ~~competitive~~same ~~landscape~~indication ~~for~~as our or our partners’ products ~~may impact product sales and the amount that can be charged for a given product~~.

~~Additionally,~~Our ~~the~~or ~~number~~our ofpartners’ ~~generic~~products ~~manufacturers~~may ~~targeting~~be ~~significant~~eligible ~~new~~for ~~generic~~periods ~~opportunities~~of ~~with~~regulatory ~~Hatch-Waxman~~ exclusivity, oras ~~which~~described ~~are~~elsewhere ~~complex~~in tothis ~~develop,~~annual ~~continues to increase~~report. This ~~Other~~exclusivity, ~~companies~~however, may ~~also~~not beadequately ~~developing~~protect ~~drugs~~our ~~using~~or ~~the 505(b)(2) pathway that are substantially similar to~~ our partners’ products ~~and/or~~from ~~product candidates~~competition. If ~~The~~any ~~failure~~periods toof ~~successfully~~exclusivity ~~develop~~that ~~and~~we ~~commercialize~~or ~~highly~~our ~~complex~~partners ~~products~~may ~~could~~have ~~adversely~~not ~~affect~~adequately ~~our~~protected ~~sales~~the ~~and~~applicable ~~profitability.~~product ~~For~~or ~~instance,~~if towe ~~the~~or ~~extent~~they ~~that~~do ~~another~~not ~~company~~receive ~~receives~~or alose ~~period~~anticipated periods of regulatory exclusivity, ~~the~~we ~~FDA~~or they may ~~not~~be ~~make~~subject ~~our~~to abbreviated ~~application~~new ~~effective~~drug ~~during~~application ~~that~~(“ANDA”) and/or ~~company’s~~505(b)(2) ~~exclusivity~~competition ~~period. This~~sooner ~~would~~than ~~delay~~we ~~our~~anticipate. We ~~and~~or our partners’ ~~marketing of products and~~ may ~~prevent~~also usbe orsubject ~~them~~to ~~from~~increased ~~establishing~~generic acompetition ~~sufficient~~sooner ~~market~~than ~~share~~anticipated ~~for our product. Similarly~~as the FDA, ~~should another company obtain FDA approval for a pharmaceutically equivalent product to one of our product candidates~~Congress, weand ~~may~~the noAdministration ~~longer~~have betaken ~~able~~steps to ~~use~~facilitate the ~~505(b)(2)~~approval ~~pathway. In~~of ~~that~~generic ~~case,~~products itand isincrease ~~the~~competition ~~FDA’s~~in ~~policy that~~ the ~~appropriate~~prescription ~~submission~~drug ~~would be an ANDA~~market. New Welegislative ~~may,~~and ~~however,~~regulatory ~~not~~efforts becould ~~able~~ultimately ~~to immediately submit an ANDA or~~ have an ~~ANDA~~adverse ~~approval~~impact ~~made~~on ~~effective,~~our asbusiness weand ~~could~~results ~~be blocked by others’ periods~~ of ~~patent and regulatory exclusivity protection~~operation.

Further, regardless of any granted exclusivities, we or our partners may face competition from products or product uses that are not otherwise blocked by our or our partners’ patents or exclusivities. For example, exclusivity does not prevent physicians from prescribing a similar product even if it is not approved for the same indication. By further example, in 2019, the FDA approved Clarus’s product, JATENZO®, an oral testosterone undecanoate capsule for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The introduction of JATENZO®, which was launched for commercial sale in February 2020, and other oral or competing testosterone products may materially impact our sales of XYOSTED®. Moreover, we or our partners may face competition from other products intended for the same use and/or that otherwise contain the same active ingredients, which may be less expensive than our or our partners’ products. Any increase or changes in the competitive landscape for our or our partners’ products may impact product sales and the amount that can be charged for a given product.

Additionally, the number of generic manufacturers targeting significant new generic opportunities with Hatch-Waxman exclusivity, or which are complex to develop, continues to increase. Other companies may also be developing drugs using the 505(b)(2) pathway that are substantially similar to our products and/or product candidates. The failure to successfully develop and commercialize highly complex products could adversely affect our sales and profitability. For instance, to the extent that another company receives a period of regulatory exclusivity, the FDA may not accept or make our application effective during that company’s exclusivity period. This would delay our and our partners’ marketing of products and may prevent us or them from establishing a sufficient market share for our product. Similarly, should another company obtain FDA approval for a pharmaceutically equivalent product to one of our product candidates, we may no longer be able to use the 505(b)(2) pathway. In that case, it is the FDA’s policy that the appropriate submission would be an ANDA. We may, however, not be able to immediately submit an ANDA or have an ANDA approval made effective, as we could be blocked by others’ periods of patent and regulatory exclusivity protection.

Although we have applied for and/or have received several patents and trademarks, we may be unable to protect our intellectual property, which would negatively affect our ability to compete.

Our success depends, in part, on our ability to obtain and enforce patents for our products and device technologies and to preserve our trade secrets and other proprietary information. If we cannot do so, our competitors may exploit our innovations and deprive us of the ability to realize revenues and profits from our developments.

We currently hold numerous patents and have numerous patent applications pending in the ~~United~~U.S. ~~States~~ and other countries. Our current patents may not be valid or enforceable and may not protect us against competitors that challenge our patents, obtain their own patents that may have an adverse effect on our ability to conduct business, or are able to otherwise circumvent our patents. Additionally, our products and technologies are complex, and one patent may not be sufficient to protect our products where a series of patents may be needed. Further, we may not have the necessary financial resources to enforce or defend our patents or patent applications. Even issued patents may later be modified or declared invalid by the U.S. Patent and Trademark Office by analogous foreign offices or in legal proceedings. In addition, any patent applications we may have made or may make relating to inventions for our actual or potential products and technologies may not result in patents being issued or may result in patents that provide insufficient or incomplete coverage for our inventions.

We may seek to protect our patent rights by asserting an allegation of infringement against third parties. For instance, for any products approved via the NDA pathway, we will be required to submit certain patent information for inclusion in the FDA’s Orange Book. There is no guarantee, however, that we will be able to obtain patents that may be included in the Orange Book. ~~Moreover, the rules for submitting patents to the Orange Book are detailed and complex.~~ To the extent that we do not include a patent in the Orange Book, we would not be able to avail ourselves of the protections provided in the Hatch Waxman Act, including the possibility of a 30-month stay. To the extent that we include a patent in the Orange Book that should not be included, we could also face legal action.

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protections provided in the Hatch Waxman Act, including the possibility of a 30-month stay. To the extent that we include a patent in the Orange Book that should not be included, we could also face legal action.

If third parties identify our products as reference listed drugs in any ANDAs or 505(b)(2) applications, they will be required to provide patent certifications in their applications for our listed patents, and notifications to us. In the event such third parties make paragraph IV certifications, we would be entitled to file a patent infringement lawsuit, and if that is accomplished within 45 days after receiving the notification, it would trigger a 30-month stay against the FDA making the approval of the third party’s application effective. Patent litigation is costly and time consuming and the outcome is uncertain. There is no assurance of success with any patent litigation. Depending on the ultimate outcome of the litigation it may have an adverse effect on results of operations and our market penetration. We may also determine that it is not in our business interest to file a patent infringement lawsuit in response to a paragraph IV certification.

To protect our trade secrets and proprietary technologies and processes, we rely, in part, on confidentiality agreements with employees, consultants and advisors. These agreements may not provide adequate protection for our trade secrets and other proprietary information in the event of any unauthorized use or disclosure, or if others lawfully and independently develop the same or similar information. In addition, we may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties. We employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties. We may also be subject to claims that former employers or other third parties have an ownership interest in our patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if we do not prevail, we could be required to pay substantial damages and could lose rights to important intellectual property. Even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.

Others may bring infringement claims against us, which could be time-consuming and expensive to defend and the outcomes could be uncertain.

Third parties may claim that the manufacture, use or sale of our drug delivery technologies infringes their patent rights. As with any litigation where claims may be asserted, we may have to seek licenses, defend infringement actions or challenge the validity of those patents in the U.S. Patent and Trademark Office or the courts. If these claims are not resolved favorably, we may not be able to continue to develop and commercialize our product candidates. Even if we were able to obtain rights to a third party’s intellectual property, these rights may be non-exclusive, thereby giving our competitors potential access to the same intellectual property. Moreover, because we are developing and may develop products using the ANDA and/or 505(b)(2) pathways, we may face a greater risk of patent infringement lawsuits and associated 30-month stay in the event that we or our partners make a paragraph IV certification as part of our FDA marketing application. If we are found liable for infringement or are not able to have these patents declared invalid or unenforceable, we may be liable for significant monetary damages, encounter significant delays in bringing products to market or be precluded from participating in the manufacture, use or sale of products or methods of drug delivery covered by others’ patents. Any litigation could be costly and time-consuming and could divert the attention of our management and key personnel from our business operations. In addition, there is risk that a court will order us or our partners to pay the other party damages for having violated the other party's patents. We may not have identified, or be able to identify in the future, U.S. or foreign patents that pose a risk of potential infringement claims. In addition, a 505(b)(2) application or ANDA approval will not be made effective until any existing nonpatent exclusivities have expired or, if possible, is carved out from the label. Accordingly, we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject to significant delay and patent litigation. Ultimately, we may be unable to commercialize some of our product candidates as a result of patent infringement claims, which could potentially harm our business.

Additionally, we are developing and may develop other products in the future for ourselves and/or our partners using the ANDA and/or 505(b)(2) pathways. Our partners may also do the same. There can be no assurance that those products will not be subject to litigation, which could delay or prohibit the launch of those potential products. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our partners’ products and/or product candidates and/or proprietary technologies infringe their intellectual property rights, including litigation resulting from filing under paragraph IV of the Hatch-Waxman Act. These lawsuits could claim that there are existing patent rights for such drugs and this type of litigation can be costly and could adversely affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we or our commercialization partners are infringing the third party’s patents and would order us or our partners to stop the activities covered by the patents. In addition, there is a risk that a court will order us or our partners to pay the other party damages for having violated the other party’s patents. Moreover, regardless of whether we and/or our partners are ultimately successful in defending a patent infringement suit, we and/or they may be significantly delayed by a 30 month stay in the event we and/or they make a paragraph IV certification. In addition, a 505(b)(2) application or ANDA approval will not be made effective until any existing nonpatent exclusivity have expired or, if possible, is carved out from the label. Accordingly, we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject to significant delay and patent litigation before such product candidates may be commercialized, if at all.

Product liability, product recalls and related claims could harm our business.

The development, manufacture, testing, marketing and sale of pharmaceutical products and medical devices are associated with significant risks of product liability claims or recalls. Side effects or adverse events known or reported to be associated with, or manufacturing defects in, the products sold by us could exacerbate a patient’s condition or could result in serious injury or impairments or even death. This could result in product liability claims and/or recalls of one or more of our products. Product liability claims may be brought by individuals seeking relief for themselves, or by groups seeking to represent a class of injured patients. Further, third party payers, either individually or as a putative class, may bring actions seeking to recover monies spent on one of our products. While we have not had to defend against any product liability claims to date, as sales of our products increase, we may have product liability claims made against us. The risk of product liability claims may also increase if a company receives a warning letter from a regulatory or other enforcement agency. We cannot predict the frequency, outcome or cost to defend any such claims. Product liability insurance coverage is expensive, can be difficult to obtain and may not be available in the future on acceptable terms, or at all. Our product liability insurance may not cover all of the future liabilities we might incur in connection with the development, manufacture or sale of our products. In addition, we may not be able to continue to obtain insurance on satisfactory terms or in adequate amounts.

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~~Product~~cost ~~liability~~to defend any such claims. ~~can~~Product ~~also~~liability ~~result~~insurance incoverage ~~regulatory~~is ~~consequences~~expensive, ~~including,~~can ~~but~~be ~~not~~difficult ~~limited~~ to ~~investigations~~obtain and ~~regulatory~~may ~~enforcement~~not ~~actions,~~be asavailable ~~well~~in asthe ~~recalls,~~future ~~revocation~~on ofacceptable ~~approvals~~terms, or ~~labeling,~~at ~~marketing~~all. orOur ~~promotional~~product ~~restrictions~~liability orinsurance ~~changes. In~~may ~~addition,~~not ~~defending~~cover aall ~~product~~of ~~liability~~the ~~lawsuit~~future isliabilities ~~expensive~~we ~~and~~might ~~can~~incur ~~divert~~in ~~the~~connection ~~attention~~with ofthe ~~key~~development, ~~employees~~manufacture ~~from~~or ~~operating~~sale of our ~~business~~products. ~~Such~~In ~~claims~~addition, ~~can~~we ~~also~~may ~~impact~~not ~~our~~be ~~ability~~able to ~~initiate~~continue to obtain insurance on satisfactory terms or ~~complete~~in ~~clinical~~adequate ~~trials~~amounts.

While we maintain product and clinical trial liability insurance and evaluate our insurance requirements on an ongoing basis, a successful claim or claims brought against us in excess of available insurance coverage could subject us to significant liabilities and could have a material adverse effect on our business, financial condition, results of operations and growth prospects. Such claims could also harm our reputation and the reputation of our products, adversely affecting our ability to market our products successfully. Product liability claims can also result in regulatory consequences, including, but not limited to investigations and regulatory enforcement actions, as well as recalls, revocation of approvals, or labeling, marketing or promotional restrictions or changes. In addition, defending a product liability lawsuit is expensive and can divert the attention of key employees from operating our business. Such claims can also impact our ability to initiate or complete clinical trials.

To the extent that a product fails to conform to its specifications or comply with the applicable laws or regulations, we or our partners may be required to or may decide to voluntarily recall the product or regulatory authorities may request or require that we recall a product even if there is no immediate potential harm to a patient. Any recall of our products or products or their components that we supply to our partners could materially adversely affect our business by rendering us unable to sell those products or components for some time and by adversely affecting our reputation. Recalls are costly and take time and effort to administer. Even if a recall only initially relates to a single product, product batch, or a portion of a batch, recalls may later be expanded to additional products or batches or we or our partners may incur additional costs and need to dedicate additional efforts to investigate and rule out the potential for additional impacted products or batches. Moreover, if any of our partners recall a product due to an issue with a product or component that we supplied, they may claim that we are responsible for such issue and may seek to recover the costs related to such recall or be entitled to certain contractual remedies from us, Recalls may further result in decreased demand for our or our partners’ products, could cause our partners or distributors to return products to us for which we may be required to provide refunds or replacement products, or could result in product shortages. Recalls may also require regulatory reporting and prompt regulators to conduct additional inspections of our or our partners’ or contractors’ facilities, which could result in findings of noncompliance and regulatory enforcement actions. A recall could also result in product liability claims by individuals and third-party payers. In addition, product liability claims or other safety issues could result in an investigation of the safety or efficacy of our products, our manufacturing processes and facilities, or our marketing programs conducted by the FDA or the authorities of the EU member states. Such investigations could also potentially lead to a recall of our products or more serious enforcement actions, limitations on the indications for which they may be used, or suspension, variation, or withdrawal of approval. Any such regulatory action by the FDA, the European Medicines Agency (“EMA”) or the competent authorities of the EU member states could lead to product liability lawsuits as well.

We depend on information technology and computer systems to operate our business, and any failures or interruptions in our internal computer systems, including a data breach or cybersecurity incident, could have a negative impact on our business.

Despite the implementation of security measures, our internal computer systems and those of our current and any future partners, contractors and consultants are vulnerable to cybersecurity attacks including damage from computer viruses, unauthorized access, attacks by computer hackers and ransomware, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our manufacturing activities, development programs and business operations. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential, protected health or proprietary information, we could incur liability or damage to our reputation, and the further commercialization and development of our products and product candidates could be delayed. Likewise, data privacy or security breaches by employees or others may pose a risk that sensitive data, including our intellectual property, or trade secrets or the personal information of our employees, patients or other business partners may be exposed to unauthorized persons or to the public. There can be no assurance that our efforts, or the efforts of our partners and vendors, will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information, which could result in financial, legal, business or reputational harm to us. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyberattacks and other related breaches.

Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable laws and regulations, and we have incurred and will continue to incur costs relating to compliance with applicable laws and regulations.

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As a pharmaceutical technology company, we are subject to a large body of legal and regulatory requirements, guidance, and recommendations from a variety of regulatory authorities, such as the FDA, the EMA, and HHS OIG. In addition, as a publicly traded company we are subject to significant regulations, including the Sarbanes-Oxley Act of 2002. While we have developed and instituted a corporate compliance program based on what we believe are the current best practices and continue to update the program in response to newly implemented regulatory requirements and guidance, we cannot ensure that we are or will be in compliance with all potentially applicable regulations. Failure to comply with all potentially applicable laws and regulations could lead to the imposition of fines, cause the value of our common stock to decline, and impede our ability to raise capital or list our securities on certain securities exchanges.

We face uncertainty and risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt our operations and may materially and adversely impact our business and financial conditions.

The ~~COVID-19 pandemic (the “~~Pandemic”) continues to evolve, including the spread of new more contagious virus strains, and the related risks and uncertainty could materially and adversely affect our business, operating results and financial conditions.

Our sales force has been subject to varying limitations on its ability to visit physicians, and we are utilizing virtual meeting platforms and other forms of social media to connect with our existing and potential customers and healthcare professionals. The restrictions and closures imposed as a result of the Pandemic have also limited patient access to physicians, and we have experienced, and may continue to experience, a decrease in new prescriptions for our proprietary products. Our partners may also experience a decrease in demand for our partnered products due to the Pandemic or the related restrictions. While we have taken measures to help minimize the potential impact of the various government orders, the effects of these restrictions may negatively impact productivity and demand for our products, disrupt our business and delay development programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These restrictions and others in the future, as well as the continued uncertainty on the duration, scope and severity of the Pandemic, could negatively impact our business, operating results and financial condition.

We currently rely on many third parties to source active pharmaceutical ingredient and drug products, manufacture and assemble our devices, distribute finished products and provide various logistics activities for our business. If any of these third parties are adversely impacted by the Pandemic or the restrictions resulting from the outbreak, for example, one of our third party manufacturers’ facility had a temporary shutdown as a result of a positive COVID-19 diagnosis by an employee, if they are not able to obtain necessary supplies, or if they need to prioritize other products or customers over us or our partners, we may experience delays or disruptions in our product supply chain which could have a material and adverse impact on our business. Additionally, if we or any of these third parties require a regulatory authority inspection, we or they may be delayed in obtaining such inspection as a result of the Pandemic. These third parties may also need to deviate from their standard manufacturing procedures as a result of the Pandemic, which could adversely impact our or our partners’ products. These third parties may also need to deviate from their standard manufacturing procedures as a result of the Pandemic, which could adversely impact our or our partners’ products.

In addition, to the extent that we or our partners are conducting clinical trials, the Pandemic could cause delays or disruptions in these or future development programs. The foregoing may require that we consult with relevant review and ethics committees, Institutional Review Boards (“IRBs”) and the FDA, and could negatively impact our business. We may also need to make filings to the applicable regulatory authorities to account for changes that are necessary to continue to adapt to the Pandemic.

~~The~~As ~~full extent to which~~ the Pandemic continues, it may impact our ~~business or the economy as a whole is unknown~~ and ~~will~~our ~~depend~~partner’s on future developments, which are highly uncertain and cannot be predicted, such as the ultimate spread and rate of infection, the duration of the pandemic, travel restrictions and social distancing requirements, business ~~closures~~operations orin ~~business~~any ~~disruptions~~number ~~and the effectiveness~~ of ~~actions~~ways. ~~taken~~This inhas ~~the~~been ~~United~~recognized ~~States~~by ~~and in other countries to contain and treat~~ the ~~disease and to address its impact~~FDA, ~~including~~which onhas ~~financial~~promulgated ~~markets or otherwise. These effects could have~~ a ~~material~~number ~~adverse~~of ~~impact~~guidance specific on ~~our~~operations ~~business~~during ~~and~~the ~~operations~~Pandemic. To ~~the~~As ~~extent~~ the Pandemic ~~adversely affects our business and financial results~~develops, ~~it may also have~~ the ~~effect~~regulatory ofguidance ~~heightening~~may ~~many~~continue ofto ~~the~~change ~~other~~and ~~risks~~evolve, ~~described~~requiring inthat ~~this~~we ~~section~~ and ~~in the “Risk Factor” section in~~ our ~~other~~partners ~~filings~~continue ~~with the Securities and Exchange Commission. Additional risks and uncertainties not currently known~~ to usadapt ~~or that we currently deem~~ to benew ~~immaterial also may materially adversely affect our business, financial condition and/or operating results~~requirements.

The full extent to which the Pandemic may impact our business or the economy as a whole is unknown and will depend on future developments, which are highly uncertain and cannot be predicted, such as the ultimate spread and rate of infection, the duration of the Pandemic, travel restrictions and social distancing requirements, business closures or business disruptions and the effectiveness of actions taken in the U.S. and in other countries to contain and treat the disease and to address its impact, including on financial markets or otherwise. These effects could have a material adverse impact on our business and operations. To the extent the Pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this section and in the “Risk Factor” section in our other filings with the Securities and Exchange Commission. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

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We have historically incurred significant losses, and there is no guarantee that we can sustain or grow our profitability.

Although we generated net income of $46.3 million and $56.2 million for the years ended December 31, 2021 and 2020, respectively, we incurred net losses of $2.0 million for the year ended December 31, 2019. In addition, we had an accumulated deficit as of December 31, 2021 of $176.3 million. The costs for research and development of our products, product candidates and drug delivery technologies, along with marketing and selling expenses and general and administrative expenses, have been the principal causes of our historical losses. Although we have reported net earnings and earnings per share in recent two most recent annual periods, there is no guarantee we will continue to post profitable results of operations or maintain profitability on an annual or quarterly basis.

Risks Related to Regulatory Matters

Our and our partners’ product candidates are subject to the inherent risk of product development and clinical trials, in that product development and clinical trials may not be successful, and they may not receive regulatory marketing approval on a timely basis or at all. If we or our partners fail to obtain, or have delays in obtaining, regulatory approvals for any product candidates, our business, financial condition and results of operations may be materially adversely affected.

The design, development, testing, manufacturing and marketing of pharmaceutical compounds and medical devices are subject to regulation by governmental authorities, including the FDA and comparable regulatory authorities in other countries and is an inherently risky and uncertain process. To conduct our and our partners’ clinical and preclinical studies, we and they rely on third parties, including CROs and clinical trial sites to carry out the studies in accordance with the written protocol, the instructions, our and our partners’ agreements with them, and the applicable regulatory requirements. There is no guarantee that we or our partners will be able to negotiate agreements with these third parties on acceptable terms, on a timely basis, or at all. To the extent that these third parties do not carry out their responsibilities, as is required, or to the extent that we, our partners, or such third parties terminate the applicable agreements, we or our partners may need to replace them, which may take significant time, effort, and expense. Additionally, we or our partners may be subject to regulatory enforcement action for such third parties’, and our, or our partners’ actions, and the FDA or foreign regulatory authorities may find that the study data that is generated cannot form the basis for approval of a marketing application, requiring that we or our partners conduct additional preclinical and clinical studies. Moreover, investigators and CROs may be subject to conflicts of interest that compromise or appear to compromise the resulting data. Such third- parties may also have relationships with other entities that they may prioritize over the conduct of our or our partners’ studies.

Despite the time and expense associated with preclinical and clinical studies, failure can occur at any stage, and we or our partners could encounter problems that cause us or they to repeat or perform additional preclinical studies, chemistry, manufacturing and controls (“CMC”) studies or clinical trials. We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates or that may increase the cost of development, including, failure to receive FDA or IRB authorization to begin or continue a trial, negative or inconclusive results, slow or insufficient subject enrollment, failure to obtain adequate clinical supply of product candidates that meet the applicable regulatory quality requirements, and failure by us, our partners, CROs, and clinical trial sites to follow the applicable regulatory requirements, including GCPs. We or our partners may also not have sufficient funding to conduct or complete a clinical trial or pay the substantial FDA application user fees.

cost of development, including, failure to receive FDA or IRB authorization to begin or continue a trial, negative or inconclusive results, slow or insufficient subject enrollment, failure to obtain adequate clinical supply of product candidates that meet the applicable regulatory quality requirements, and failure by us, our partners, CROs, and clinical trial sites to follow the applicable regulatory requirements, including GCPs. We or our partners may also not have sufficient funding to conduct or complete a clinical trial or pay the substantial FDA application user fees.

The FDA and similar foreign authorities could also delay, limit or deny approval of a product candidate for many reasons, including because they: may not deem a product candidate to be adequately safe and effective or, in the case of a generic drug product, bioequivalent to the reference listed drug; may not find that we have adequately bridged to the reference listed drug, in the case of a 505(b)(2) application; may not find the data, including foreign data, from preclinical studies, CMC studies and clinical trials to be sufficient to support a claim of safety and efficacy; may interpret data from preclinical studies, CMC studies and clinical trials significantly differently than we or our partners do; may not approve the manufacturing processes or facilities associated with our product candidates; may not agree with the pathway that we or our partners have chosen for our product candidates, requiring us to pursue more difficult approval pathways, including submitting full NDAs, or may not agree with our or our partners’ intended indications; may find that our or our partners reliance on a reference listed drug for an ANDA or 505(b)(2) application or literature for a 505(b)(2) application is not appropriate; may not agree with the design and/or implementation of our clinical and/or pre-clinical studies; may require us to conduct additional clinical and/or pre-clinical studies or gather additional information or data; may find safety or efficacy issues with respect to a reference listed drug, either before or after a product candidate’s approval; may change approval policies (including with respect to our product candidates’ class of drugs), or adopt new regulations; may not meet their review goal dates; or may not accept a submission due to, among other reasons, the content or formatting of the submission. Significant delays also could shorten any periods during which we or our partners may have the exclusive right to commercialize our product candidates, which would allow competitors to bring products to market before we do.

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Undesirable side effects caused by any product candidate that we or our partners develop, a lack of bioequivalence for ANDA product candidates, and/or an inability to demonstrate product candidate efficacy could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications or cause us or our partners to evaluate the future of our development programs. Undesirable side effects could also interrupt, delay, or halt clinical trials. The regulatory review and approval process is lengthy, expensive and inherently uncertain.

Our and our partners’ reliance on FDA’s 505(b)(2) and ANDA pathways may also impact the risk of development that we would not be subject to under a full NDA. These pathways are continually evolving. Based on evolving regulatory policies, we or our partners may not be able to use the 505(b)(2) or ANDA pathway in the future, requiring that we or they pursue the costlier and time consuming 505(b)(1) full NDA pathway. We or our partners may also face delays or impediments to the approval of any product candidates if a competitor files a citizen petition with the FDA. Moreover, any FDA intervening approvals of drug products that are the same or similar to our or our partners’ product candidates could impact our potential market position and prospects, as well as impact the approval of our or our partners’ product candidates. By example, should the FDA approve a product that is pharmaceutically equivalent to one of our or our partners’ 505(b)(2) NDA product candidates before we or they submit a marketing application, we or they would be required to change the marketing application to an ANDA application. Similarly, should FDA approve a product that is more similar to any of our or our partners’ ANDA product candidates than the current reference listed drug, we or our partners may be required to change the reference listed drug for the ANDA. Either of these scenarios could require additional development work, and clinical or preclinical studies. FDA intervening approvals could also delay the timeframe within which we or our partners may submit product applications to the FDA or within which the FDA may make approvals of such applications effective, due to periods of patent protections and regulatory exclusivities for the newly approved product. Because the FDA cannot disclose whether such predicate product is under development or has been submitted at any time during another company’s review cycle, we would not know whether there are any intervening products or applications until such product or application is approved.

Should the FDA or another regulatory authority refuse to approve any of our or our partners’ product candidates, we or they will be delayed in marketing, may need to conduct additional studies and collect additional data and information, and may need to make changes to the product candidates or their manufacturing processes, any of which could materially harm our business and results of operation. Moreover, if granted, any regulatory approvals may be subject to certain limits or other costly and burdensome requirements, such as labeled warnings, including box warnings, limitations on the indicated use, and post-approval requirements. The FDA also can withdraw product clearances and approvals for failure to comply with regulatory requirements or if unforeseen problems follow initial marketing. Any limitation on use imposed by the FDA or foreign regulatory agencies would adversely affect the marketing of these products and our ability to generate product revenue, which would adversely affect our financial condition and results of operations.

InWith ~~other~~respect ~~jurisdictions~~to any new products, we, ~~and~~may ~~the~~also ~~pharmaceutical~~face ~~companies~~increased risk with ~~which~~respect weto ~~are~~regulatory ~~developing~~approval, ~~technologies~~compliance ~~(both~~and ~~drugs~~commercialization. ~~and~~By ~~devices)~~example, ~~must~~while ~~obtain~~TLANDO® ~~required~~has ~~regulatory~~received ~~approvals~~tentative ~~from~~FDA ~~regulatory~~approval, ~~agencies~~it ~~and~~may ~~comply~~never ~~with~~receive ~~extensive~~final ~~regulations~~approval. ~~regarding~~Moreover, ~~safety~~to ~~and~~the ~~quality. If~~extent ~~approvals~~that towe ~~market~~do ~~the~~not ~~products~~have ~~are~~prior ~~delayed,~~experience ifwith wea ~~fail~~specific tokind ~~receive~~of ~~these approvals~~product, orsuch ifas the TLANDO® gel capsules, we ~~lose~~will ~~previously~~need ~~received~~to ~~approvals,~~acquire ~~our~~the ~~revenues~~necessary ~~may~~experience ~~not~~and ~~materialize~~expertise orto ~~may~~successfully ~~decline. We~~manufacture ~~may~~and ~~not~~commercialize bethe ~~able~~product, towhich ~~obtain~~we ~~all~~may ~~necessary~~never ~~regulatory~~be ~~approvals.~~able to do.

41In other jurisdictions, we, and the pharmaceutical companies with which we are developing technologies (both drugs and devices), must obtain required regulatory approvals from regulatory agencies and comply with extensive regulations regarding safety and quality. If approvals to market the products are delayed, if we fail to receive these approvals, or if we lose previously received approvals, our revenues may not materialize or may decline. We may not be able to obtain all necessary regulatory approvals. Additionally, clinical data that we generate or obtain from partners from FDA regulatory filings may not be sufficient for regulatory filings in other jurisdictions and we may be required to incur significant costs in obtaining those regulatory approvals.

Additionally, clinical data that we generate or obtain from partners from FDA regulatory filings may not be sufficient for regulatory filings in other jurisdictions and we may be required to incur significant costs in obtaining those regulatory approvals.

Because our and our partners’ products and product candidates are considered to be drug/device combination products, the approval and post-approval requirements that we and they are required to comply with will be more complex.

Most of our and our partners’ products and product candidates are considered to be drug/device combination products by the FDA, consisting of a drug product and a drug delivery device. If marketed individually, each component would be subject to different regulatory pathways and reviewed by different centers within the FDA. A combination product, however, is assigned to a center that will have primary jurisdiction over its pre-market review and regulation based on a determination of the product’s primary mode of action, which is the single mode of action that provides the most important therapeutic action. In the case of our and our partners’ products and product candidates, the primary mode of action is attributable to the drug component of the products, which means that the Center of Drug Evaluation and Research has primary jurisdiction over the products’ premarket development and review. These products and product candidates will be and have been subject to the FDA drug approval process, and will not require a separate FDA clearance or approval for the device component. Even though these products and product candidates will not require a separate FDA clearance or approval, both the drug and device centers within the FDA will review the marketing application for safety, the efficacy of both the drug and device component, including the design and reliability of the injector, and a number of other different areas, such as to ensure that the drug labeling adequately discloses all relevant information and risks, and to confirm that the instructions for use are accurate and easy to use. These reviews could increase the time needed for review completion of a successful application and may require additional studies, such as usage studies, to establish the validity of the instructions. Such reviews and requirements may extend the time necessary for the approval of drug-device combinations. In the case of combination product candidates for which we or our partners are seeking approval via the ANDA pathway, it is also possible that the agency may decide that the unique nature of combination products leads it to question the claims of bioequivalence and/or same labeling, resulting in the need to refile the application under Section 505(b)(2). This may result in delays in product approval and may cause us or our partners to incur additional costs associated with testing, including clinical trials. Approval via the 505(b)(2) pathway may also result in additional selling expenses and a decrease in market acceptance due to the lack of substitutability by pharmacies or formularies. In addition, approval under the 505(b)(2) or ANDA regulatory pathway is not a guarantee of an exclusive position for the approved product in the marketplace.

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approval process and will not require a separate FDA clearance or approval for the device component. Even though these products and product candidates will not require a separate FDA clearance or approval, both the drug and device centers within the FDA will review the marketing application for safety, the efficacy of both the drug and device component, including the design and reliability of the injector, and a number of other different areas, such as to ensure that the drug labeling adequately discloses all relevant information and risks, and to confirm that the instructions for use are accurate and easy to use. These reviews could increase the time needed for review completion of a successful application and may require additional studies, such as usage studies, to establish the validity of the instructions. Such reviews and requirements may extend the time necessary for the approval of drug-device combinations. In the case of combination product candidates for which we or our partners are seeking approval via the ANDA pathway, it is also possible that the agency may decide that the unique nature of combination products leads it to question the claims of bioequivalence and/or same labeling, resulting in the need to refile the application under Section 505(b)(2). This may result in delays in product approval and may cause us or our partners to incur additional costs associated with testing, including clinical trials. Approval via the 505(b)(2) pathway may also result in additional selling expenses and a decrease in market acceptance due to the lack of substitutability by pharmacies or formularies. In addition, approval under the 505(b)(2) or ANDA regulatory pathway is not a guarantee of an exclusive position for the approved product in the marketplace.

Further, although precedent and guidance exist for the approval of such combination products, there is no assurance that the FDA will not change what it requires or how it reviews submissions. Changes in review processes or the requirement for the study of combination products could delay anticipated launch dates or be cost prohibitive. Such delay or failure to launch these products or devices could adversely affect our revenues and future profitability. If our or our partners’ combination product candidates are approved, we, our partners, and any of our respective contractors will be required to comply with FDA regulatory requirements related to both drugs and devices. For instance, drug/device combination products must comply with both the drug cGMPs and device QSRs. Depending on whether the drug and device components are at the same facility, however, the FDA regulations provide a streamlined method to comply with both sets of requirements. The FDA has specifically promulgated guidance on injectors, which discuss FDA’s requirements with respect to marketing application and post-market injector design controls and reliability analyses. Additionally, drug/device combination products will be subject to additional FDA and constituent part reporting requirements. These requirements will require additional effort and monetary expenditure to ensure that our and our partners’ products and product candidates.

We and our partners are subject to ongoing obligations and continued regulatory review, which may result in significant additional expense for our and their approved and unapproved products. Failure to comply with these obligations could result in regulatory and/or legal consequences.

Our and our partners’ products and product candidates are subject to extensive and rigorous government regulation by the FDA and ~~other~~ foreign regulatory agencies, including requirements related to research, development, pre-clinical and clinical testing before and after product approval, manufacture, safety, effectiveness, recordkeeping, reporting, labeling, packaging, storage, distribution, deviation, approval, facility registration and product listing, the payment of user fees, advertising, marketing, promotion, sale, distribution, sampling, and import and export of pharmaceutical and medical device products. Because our and our partners’ products and product candidates are drug/device combination products, we and they will have to comply with more regulatory requirements that would otherwise be required for products that are not combination products. Failure to comply with FDA and other applicable regulatory requirements may, either before or after product approval, subject us to administrative or judicially imposed sanctions. Moreover, were we or our partners to seek regulatory approval for additional indications or uses of any products that we or they may have already received marketing approval for, we or they would be subject to the risks of product development, including the failure to obtain regulatory approval. The applicable FDA, HHS and other governmental policies, laws, and regulations may also change, and additional laws, policies, and regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates or products, or that could impose additional regulatory obligations on us. ~~By example, the change in administration in the U.S. may result in new regulatory, revised, postponed or frozen requirements and associated compliance obligations.~~

The FDA and foreign regulatory agencies will continue to monitor products after approval for continued safety, efficacy, and compliance. We, our partners, and our independent contractors will also be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with regulatory requirements. Later discovery of previously unknown adverse events or that the drug is less effective than previously thought or other problems with our products, manufacturers, or manufacturing processes, or failure to comply with regulatory requirements both before and after approval, may yield various results, including warning letters, untitled letters, cyber letters, manufacturing and distribution restrictions, changes to product labeling, post-marketing study or other requirements such as REMS, refusal to approve marketing applications or supplements, withdrawal of marketing application approvals, removal of the product from the market, labeling or promotional material modifications, product recalls, market withdrawals, field corrections, clinical holds and suspensions of clinical studies, fines, penalties, disgorgement, corporate integrity agreements, consent decrees, seizure, injunctions, prohibition on importing and exporting, dear healthcare provider letters, adverse publicity, FDA debarment, debarment from government procurement programs or

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~~thought~~Table or other problems with our products, manufacturers, or manufacturing processes, or failure to comply with regulatory requirements both before and after approval, may yield various results, including warning letters, untitled letters, cyber letters, manufacturing and distribution restrictions, changes to product labeling, post-marketing study or other requirements such as REMS, refusal to approve marketing applications or supplements, withdrawal of marketing application approvals, removal of the product from the market, labeling or promotional material modifications, product recalls, market withdrawals, field corrections, clinical holds and suspensions of clinical studies, fines, penalties, disgorgement, corporate integrity agreements, consent decrees, seizure, injunctions, prohibition on importing and exporting, dear healthcare provider letters, adverse publicity, FDA debarment, debarment from government contracts or refusal of orders under existing contracts, and exclusion from federal healthcare programs, among other consequences. Any of these events could have other material adverse effects on our operations and business.Contents

Werefusal ~~and~~of ~~our~~orders ~~independent~~under ~~contractors,~~existing ~~distributors~~contracts, ~~prescribers,~~ and ~~dispensers~~exclusion ~~are~~from ~~required~~federal tohealthcare ~~comply~~programs, ~~with~~among ~~regulatory~~other ~~requirements~~consequences. Any ~~related~~of tothese ~~controlled~~events ~~substances~~could ~~for~~have ~~XYOSTED®,~~other ~~which~~material ~~will~~adverse ~~require~~effects ~~the~~on ~~expenditure~~our ofoperations ~~additional time~~ and ~~will incur additional expenses to maintain compliance~~business.

~~XYOSTED®~~For iscertain aof ~~drug/device~~our ~~combination product in which the drug product is testosterone~~products, ~~a Schedule III controlled substance. Accordingly,~~ we, and our independent contractors, distributors, prescribers, and dispensers must comply with Federal controlled substances laws and regulations, enforced by the U.S. Drug Enforcement Administration (“DEA”), as well as state-controlled substances laws and regulations enforced by state authorities. These requirements include, but are ~~not~~required ~~limited~~ to, ~~registration,~~comply ~~security,~~with ~~recordkeeping,~~regulatory ~~reporting, storage, distribution, importation, exportation, inventory, and other~~ requirements~~. These~~ ~~requirements~~related ~~are~~to ~~enforced by the DEA through periodic inspections. Not only must continuous~~ controlled ~~substance registration be maintained~~substances, which ~~but compliance with the applicable controlled substance requirements~~ will require ~~significant efforts and expenditures, which could also inhibit~~ the ~~successful~~expenditure ~~commercialization~~ of ~~XYOSTED®. If~~additional wetime and ~~our~~will ~~contractors,~~incur ~~distributors,~~additional ~~prescribers,~~expenses ~~and dispensers do not comply with the applicable controlled substance requirements, we or they may be subject~~ to ~~administrative,~~maintain ~~civil or criminal enforcement, including civil penalties, refusals to renew necessary registrations, revocation of registrations, criminal proceedings, or consent decrees~~compliance.

Certain of our products are controlled substances and accordingly, we, and our contractors, distributors, prescribers, and dispensers must comply with Federal controlled substances laws and regulations, enforced by the U.S. Drug Enforcement Administration (“DEA”), as well as state-controlled substances laws and regulations enforced by state authorities. These requirements include, but are not limited to, registration, security, recordkeeping, reporting, storage, distribution, importation, exportation, inventory, and other requirements. These requirements are enforced by the DEA through periodic inspections. Not only must continuous controlled substance registration be maintained, but compliance with the applicable controlled substance requirements will require significant efforts and expenditures, which could also inhibit the successful commercialization. If we and our contractors, distributors, prescribers, and dispensers do not comply with the applicable controlled substance requirements, we or they may be subject to administrative, civil or criminal enforcement, including civil penalties, refusals to renew necessary registrations, revocation of registrations, criminal proceedings, or consent decrees.

Any relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-party payers in connection with our current and future business activities are and will continue to be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, marketing expenditure tracking and disclosure (or “sunshine”) laws, government price reporting, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face penalties, contractual damages, reputational harm, diminished profits and future earnings.

Our business operations and activities may be directly, or indirectly, subject to various federal, state and local fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal FCA and similar laws in some state and foreign markets. These laws may impact, among other things, our current activities with principal investigators and research subjects, as well as proposed and future sales, marketing and education programs. In addition, we may be subject to patient privacy regulation by the federal government, state governments and foreign jurisdictions in which we conduct our business. The laws in the U.S. that may affect our ability to operate are further discussed above in the “Government Regulation” section of this Form 10-K.

Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and these changes could have a material adverse effect on our business and financial condition.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (together “the Healthcare Reform Act”) substantially changes the way healthcare is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry. Recently, the law’s individual health insurance mandate was repealed and manufacturers’ responsibility for the cost of prescriptions in the Medicare Part D donut hole has increased. We expect that the Healthcare Reform Act, as currently enacted or as it may be amended in the future, and other healthcare reform measures at the federal and state level that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our existing products or to successfully commercialize our product candidates, if approved. For example, CMS recently ~~has~~ finalized (and subsequently rescinded) a rule establishing a pricing model for Medicare Part B drugs based on the average price among other industrialized countries. This type of regulatory development, including if extended to other federal healthcare programs, could have a significant impact on our business.

To help patients afford ~~our~~certain ~~products~~of ~~XYOSTED®~~our ~~and OTREXUP®~~products, we offer discount, rebate, and co-pay coupon programs. Co-pay coupon programs have received some negative publicity related to their use to promote branded pharmaceutical products over other less costly alternatives. CMS recently has issued a regulation imposing additional obligations on manufacturers in order to continue excluding such programs from government pricing calculations to avoid payment of increased Medicaid rebates. In recent years, other pharmaceutical manufacturers have been named in class action lawsuits challenging the legality of their co-pay programs under a variety of federal and state laws. In addition, at least one insurer has directed its network pharmacies to no longer accept co-pay coupons for certain specialty drugs the insurers identified. Our co-pay coupon programs could become the target of similar lawsuits or insurer actions. It is possible that the outcome of litigation against other manufacturers, changes in insurer policies regarding co-pay coupons, and/or the introduction and enactment of new legislation or regulatory action could restrict or otherwise negatively affect these programs.

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We are dependent on third parties to decide to use our and our partners’ products and to make them readily available at the point of care throughout their networks of pharmacies.

In addition to extensive internal efforts, the successful commercialization of our and our partners’ products require many third parties, over which we have no control, to decide to use them, and to make them readily available at the point of care throughout their networks of pharmacies. These third parties include HMOs, long term care facilities, and pharmacy benefit managers, or PBMs, which use pharmacy and therapeutics committees, commonly referred to as P&T committees, to make purchasing and reimbursement decisions. We cannot guarantee that we and/or our partners will be successful in getting the approvals we need from sufficient P&T committees quickly enough to maintain and grow sales of our or our partners’ products.

Risks Related to our Common Stock

The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors.

The trading price for our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock trades depends upon a number of factors, including our historical and anticipated operating results, our financial situation, clinical trial results, announcements of technological innovations or new products by us, our partners or our competitors, our ability or inability to raise the additional capital we may need and the terms on which we raise it, and general market and economic conditions. Some of these factors are beyond our control. Broad market fluctuations may lower the market price of our common stock and affect the volume of trading in our stock, regardless of our financial condition, results of operations, business or prospects.

We are at risk of securities class action and similar litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because pharmaceutical companies have experienced significant stock price volatility in recent years. For example, on October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities against us, Robert F. Apple and Fred M. Powell. In addition, in January 2018, three stockholders filed separate derivative actions, one in the District of New Jersey and two in the Superior Court of New Jersey Chancery Division, Mercer County, purportedly on our behalf, against certain directors and officers, as well as the Company as a nominal defendant. There can be no assurance that we will ultimately prevail in these legal proceedings. Even if we are successful and ultimately prevail, litigation could be costly to defend and divert management’s attention and resources, which could further materially harm our financial condition and results of operations.

~~Future~~Our ~~conversions~~ability orto ~~exercises~~use byour ~~holders~~net ofoperating ~~options~~loss ~~could~~carryforwards ~~dilute~~and ~~our~~certain ~~common~~other ~~stock~~tax attributes may be limited.

As of December 31, 2020, we had approximately 10.8 million stock options outstanding and exercisable, with a weighted average exercise price of $2.49 per share. Purchasers of our common stock could therefore experience dilution of their investment when and if the above options are exercised.

Sales of our common stock by our officers and directors may lower the market price of our common stock.

As of December 31, 2020, our officers and directors beneficially owned an aggregate of approximately 10.4 million shares or 6% of our outstanding common stock, including stock options exercisable within 60 days. If our officers and directors, or other stockholders, sell a substantial amount of our common stock, it could cause the market price of our common stock to decrease.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

If we do not generate sufficient net taxable income in the future, our ability to use our net operating loss carryforwards to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us.

Anti-takeover effects of certain certificate of incorporation and bylaw provisions could discourage, delay or prevent a change in control.

Our certificate of incorporation authorizes our board of directors, without action of our stockholders, to designate and issue preferred stock in one or more series, with such rights, preferences and privileges as the board of directors shall determine. In addition, our bylaws grant our board of directors the authority to adopt, amend or repeal all or any of our bylaws, subject to the power of the stockholders to change or repeal the bylaws. In addition, our bylaws limit who may call meetings of our stockholders.

44ITEM 1B. UNRESOLVED STAFF COMMENTS

Item 1B. UNRESOLVED STAFF COMMENTS

None.

~~Item~~ITEM 2. PROPERTIES

Our ~~corporate~~properties ~~headquarters~~consist isof ~~located~~leased ~~in Ewing~~office, ~~New Jersey. We lease the 13~~laboratory,~~700~~ ~~square~~warehouse ~~foot~~and ~~facility~~manufacturing ~~under an operating lease, which expires in October 2021~~facilities. We ~~also~~ lease ~~approximately~~our ~~18,000~~corporate ~~square~~headquarters ~~feet~~located ofin ~~office~~Ewing, ~~laboratory~~New ~~and warehouse space in Plymouth~~Jersey, aprimarily ~~suburb~~consisting of ~~Minneapolis,~~office ~~Minnesota, which expires in March 2022~~space. InWe ~~July~~also ~~2019,~~lease ~~we entered into~~ a ~~new~~building ~~lease~~in ~~for 75~~Minnetonka,~~000~~ ~~square~~Minnesota ~~feet~~consisting of office, laboratory, manufacturing and warehousing space ~~in Minnetonka, Minnesota~~. ~~The lease term is 12.5 years and expires in December 2031.~~ We believe ~~that~~ our current facilities are sufficient for our existing needs and to support future anticipated business growth.

~~Item 3. LEGAL PROCEEDINGS~~53

~~The~~Table ~~information set forth under “Note 16—Commitments and Contingencies—Pending Litigation” to the consolidated financial statements included in Part II, Item 8~~ of ~~this Form 10-K is incorporated herein by reference.~~Contents

~~Although~~Additional ~~the~~information ~~results~~related ofto ~~actual,~~lease ~~pending~~obligations ~~or threatened legal proceedings and litigation cannot be predicted with certainty, we do not believe that there~~ is aincluded ~~reasonable~~in ~~possibility~~Item ~~that~~7 ~~the final outcome~~ of ~~these~~Part ~~matters~~II ~~will have a material adverse effect on our business or financial results. Regardless~~ of ~~the~~this ~~final~~Annual ~~outcome,~~Report ~~however, litigation can have an adverse impact~~ on usForm ~~because of defense or settlement costs, diversion of management resources, harm to our reputation and brand, and other factors~~10-K.

~~Item~~ITEM 43. LEGAL ~~MINE SAFETY DISCLOSURES~~PROCEEDINGS

The information set forth under “Note 16. Commitments and Contingencies – Pending Litigation” to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K is incorporated herein by reference.

Although the results of actual, pending or threatened legal proceedings and litigation cannot be predicted with certainty, we do not believe that there is a reasonable possibility that the final outcome of these matters will have a material adverse effect on our business or financial results. Regardless of the final outcome, litigation could have an adverse impact on us because of defense or settlement costs, diversion of management resources, harm to our reputation and brand, and other factors.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

4554

Table of Contents

PART II

~~Item~~ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock trades on the NASDAQ Capital Market under the trading symbol “ATRS”.

Common Shareholders

As of February 28, ~~2021~~2022, we had 69 shareholders of record of our common stock and approximately 21,~~823~~825 shareholders in street name. Information on securities authorized for issuance under our equity compensation plans can be found in Item 12 of Part III of this Annual Report on Form 10-K.

For information on securities authorized for issuance under our equity compensation plans see “Item 12—Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”

Dividends

We have not paid or declared ~~any~~ cash dividends on our common stock during the past ten years. Weand have no intention of paying cash dividends ~~in the foreseeable future~~ on our common stock in the foreseeable future.

Performance Graph

The graph below provides an indication of cumulative total stockholder returns (“Total Return”) for ~~the~~our ~~Company~~common stock as compared with the NASDAQ Composite Index and the NASDAQ Biotechnology Stock Index. The graph covers the period beginning December 31, ~~2015,~~2016 through December 31, ~~2020~~2021. The graph assumes $100 was invested inat ~~each~~market ofclose on December 31, 2016 in our common stock, the NASDAQ Composite Index and the NASDAQ Biotechnology Stock Index onand ~~December~~that ~~31,~~all ~~2015~~dividends ~~(based~~were ~~upon~~reinvested. ~~the~~The ~~closing~~graph ~~price~~is ofnot ~~each).~~necessarily ~~Total~~indicative ~~Return~~of ~~assumes~~future ~~reinvestment~~investment ~~of dividends~~performance.

	~~December 31,~~	December 31,
	2015			2016			2017		2018		2019			2020
(in actual dollars)		2016				2017				2018			2019			2020	2021
Antares Pharma, Inc.	$	~~100.00~~$	100.00	$	~~192.56~~	$85.41	$	~~164.46~~	$	~~224~~$116.7974	$	~~388.43~~	$201.72	$	~~329.75~~	$171.24	$153.22
NASDAQ Composite Index		100.00			~~107.50~~	128.24		~~137.86~~		~~132~~123.5126		~~179.19~~	166.68		~~257.38~~	239.42	290.63
NASDAQ Biotechnology Index		100.00			~~78.32~~	121.06		~~94.81~~		85109.9777		~~106.95~~	136.56		~~134.42~~	171.64	170.55

4655

Table of Contents

Recent Sales of Unregistered Securities

None.

Issuer Purchases of Equity Securities

None.

~~Item~~ITEM 6. ~~SELECTED FINANCIAL DATA~~ [RESERVED]

~~The~~ITEM ~~following table summarizes certain selected financial data~~7. MANAGEMENT’S ~~The~~DISCUSSION ~~selected~~AND ~~financial~~ANALYSIS ~~data~~OF isFINANCIAL ~~derived~~CONDITION ~~from,~~AND ~~and~~RESULTS isOF qualified by reference to, our audited consolidated financial statements as of and for the years ended December 31, 2020, 2019, 2018, 2017 and 2016 and should be read in conjunction with those statements (amounts expressed in thousands, except per share amounts). OPERATIONS

	At December 31,
	2020			2019			2018			2017			2016
Balance Sheet Data:
Cash and cash equivalents	$	53,137		$	23,201		$	27,892		$	26,562		$	27,715
Investments		—			22,520			—			4,993			—
Total assets		212,531			132,751			88,277			74,338			66,325
Long-term debt		40,899			40,395			25,126			24,858			—
Accumulated deficit		(222,626	)		(278,827	)		(276,800	)		(270,285	)		(253,445	)
Total stockholders’ equity		119,115			54,500			39,001			33,547			45,218

Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is designed to provide a reader of our financial statements with a narrative from the perspective of management on our financial condition, results of operations, liquidity and certain other factors that may affect our future results. Our MD&A is presented in five sections.

	Year Ended December 31,
	2020			2019			2018			2017			2016
Statement of Operations Data:
Product sales	$	113,834		$	92,103		$	47,870		$	41,695		$	40,318
Licensing and development revenue		14,466			7,529			6,753			11,171			10,401
Royalties		21,299			24,232			8,931			1,649			1,503
Total revenues		149,599			123,864			63,554			54,515			52,222
Cost of product sales		53,960			46,267			29,094			22,317			23,909
Cost of development revenue		9,140			4,208			1,971			5,149			4,908
Research and development		10,121			10,624			12,328			11,854			19,592
Selling, general and administrative		62,759			61,773			36,762			31,646			27,930
Total operating expenses		135,980			122,872			80,155			70,966			76,339
Gain on sale of assets		—			—			12,500			860			—
Operating income (loss)		13,619			992			(4,101	)		(15,591	)		(24,117	)
Other income (expense), net		(3,698	)		(3,019	)		(2,414	)		(1,152	)		(122	)
Net income (loss) before income taxes		9,921			(2,027	)		(6,515	)		(16,743	)		(24,239	)
Income tax benefit (provision)		46,280			—			—			—			(100	)
Net income (loss)	$	56,201		$	(2,027	)	$	(6,515	)	$	(16,743	)	$	(24,339	)
Net income (loss) per share, basic	$	0.34		$	(0.01	)	$	(0.04	)	$	(0.11	)	$	(0.16	)
Net income (loss) per share, diluted	$	0.33		$	(0.01	)	$	(0.04	)	$	(0.11	)	$	(0.16	)
Weighted average common shares outstanding:
Basic		166,066			162,574			157,407			156,054			154,992
Diluted		170,155			162,574			157,407			156,054			154,992

•Company Overview

47•Results of Operations

~~Item~~•Liquidity 7.and ~~MANAGEMENT’S~~Capital ~~DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~Resources

~~You~~•Critical ~~should~~Accounting ~~read~~Policies ~~the following discussion in conjunction with Item 1A. (“Risk Factors”)~~ and ~~our~~Use ~~audited consolidated financial statements included elsewhere in this annual report. Some~~ of ~~the statements in the following discussion are forward-looking statements. See the discussion about forward-looking statements preceding Item 1. (“Business”).~~Estimates

•Off-Balance Sheet Arrangements

Our MD&A should be read in conjunction with the consolidated financial statements and related footnotes included in Item 8 of Part II of this Annual Report on Form 10-K and risk factors identified in Item 1A of Part I of this Annual Report on Form 10-K. Some of the statements included below are considered forward-looking statements. See the discussion regarding forward-looking statements preceding Item 1 of Part I of this Annual Report on Form 10-K.

The terms “Antares,” “we,” “our,” “us” or the “Company” in this Annual Report on Form 10-K, unless the context otherwise requires, refer to Antares Pharma, Inc. and its wholly owned subsidiaries.

Company Overview

Antares Pharma, Inc. ~~(“Antares,” “we,” “our,” “us” or the “Company”)~~ is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address ~~unmet~~patient needs in targeted therapeutic areas. We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to provide commercial or functional advantages, such as improved safety and efficacy, ~~reduced~~convenience, ~~side~~improved ~~effects~~tolerability, ~~convenience,~~ and enhanced patient comfort and adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed ~~significant strategic alliances and~~ partnership arrangements with several different industry leading pharmaceutical companies ~~including Pfizer, Idorsia, Teva and AMAG~~.

We market and sell in the U.S., our proprietary product XYOSTED® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED® is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration. XYOSTED® was approved by the FDA and launched for commercial sale in late 2018. In August 2020, we entered into an exclusive distribution agreement with Lunatus to distribute and promote the sale of XYOSTED® in Saudi Arabia and the United Arab Emirates. Lunatus is responsible for obtaining regulatory approval and, assuming approval, for the promotion and commercialization of the product in the territories.

WeIn ~~also~~December ~~market~~2021, ~~and~~we ~~sell~~sold ~~our~~certain ~~proprietary~~assets ~~product~~used in the operation of the OTREXUP® product under an asset purchase agreement with Otter for $44.0 million, subject to finalization of changes in closing inventory to be transferred, with $18.0 million received at closing and an additional $26.0 million to be paid in installments over a one-year period. Prior to the asset sale, we marketed and sold OTREXUP® (methotrexate) injection, ~~which is~~ a subcutaneous methotrexate injection for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis, as a proprietary product in the U.S. In conjunction with the asset sale, we entered into a supply agreement with Otter to manufacture the VIBEX® auto-injection system device at cost plus mark-up. Otter is responsible for manufacturing, formulation and testing of methotrexate and the corresponding prefilled syringe for assembly with the device manufactured by us, along with the commercialization and distribution of OTREXUP® going forward. We also entered into a license agreement with Otter granting them a worldwide, exclusive, royalty-free, fully paid-up, irrevocable, transferable license with the right to sublicense to certain patents relating to the OTREXUP® product that may relate to other products we produce.

In October 2020, we entered into an exclusive license and commercial supply agreement (the “License Agreement”) with Ferring for the marketed product NOCDURNA® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the License Agreement, we paid Ferring an upfront payment of $5.0 million upon execution and will pay an additional $2.5 million at one year from execution. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on the Company’s net sales of NOCDURNA® in the United States. We began detailing NOCDURNA® with a soft launch in the fourth quarter of 2020 and are currently executing a reintroduction of the product through a comprehensive re-launch strategy to increase awareness and demand.56

InTable ~~collaboration with Teva, we developed a version~~ of our VIBEX® auto injector for use in a generic epinephrine auto injector product that was approved by the FDA in August 2018 and launched in late fourth quarter of 2018. Teva’s Epinephrine Injection USP is indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients and was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to the branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, substitutable at the pharmacy. We are the exclusive supplier of the device and Teva is responsible for commercialization and distribution of the finished product, for which we also receive royalties on Teva’s net sales.Contents

In October 2020, we entered into an exclusive license agreement (the “NOCDURNA® License Agreement”) with Ferring for the marketed product NOCDURNA® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (“NP”) in adults who awaken at least two times per night to urinate. We began detailing NOCDURNA® with a soft launch in the fourth quarter of 2020 and are currently executing a reintroduction of the product through a comprehensive re-launch strategy to increase awareness and demand.

In October 2021, we entered into an exclusive license agreement (the “TLANDO® License Agreement”) with Lipocine for the product TLANDO® (testosterone undecanoate) in the U.S., a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO® was granted tentative approval from the FDA in December 2020 and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus for JATENZO® on March 27, 2022. On February 3, 2022, we announced the FDA’s acceptance of our NDA resubmission for TLANDO® with a target action date set for March 28, 2022. We continue to prepare for the launch of TLANDO® in 2022 pending final FDA approval after the expiration of JATENZO®’s exclusivity period. Under the terms of the TLANDO® License Agreement, we paid Lipocine an upfront payment of $11.0 million. Lipocine is eligible for additional milestone payments up to $10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO® in the U.S. We will be responsible for the manufacturing and commercialization of TLANDO®.

The TLANDO® License Agreement also grants us the option to license and develop LPCN 1111 (TLANDO XR) in the U.S., a potential once daily oral testosterone product containing testosterone tridecanoate in development for the treatment of hypogonadism in adult males. If elected, upon exercise of the option, we will be required to pay an additional $4.0 million in license fees in two installments and will be responsible for additional development and commercial milestone payments as well as tiered royalties on net sales of TLANDO XR in the U.S. In addition, we will be responsible for completing the development program including the conduct of a Phase 3 clinical trial and applying for regulatory approval in the U.S.

In collaboration with Teva, we developed a version of our VIBEX® auto injector for use in a generic epinephrine auto injector product that was approved by the FDA. Teva’s Epinephrine Injection USP is indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients and was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to the branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, substitutable at the pharmacy. We are the exclusive supplier of the device and Teva is responsible for commercialization and distribution of the finished product, for which we also receive royalties on Teva’s net sales.

Through our commercialization partner Teva, we sell Sumatriptan Injection USP indicated in the U.S. for the acute treatment of migraine and cluster headache in adults.

~~Under~~We anare the exclusive ~~license~~supplier ~~and~~of ~~development~~the ~~agreement with AMAG~~device, ~~we developed, manufacture and supply~~ a variation of our VIBEX® QuickShot® subcutaneous auto injector ~~for~~developed ~~use~~by ~~with~~us, ~~AMAG’s~~for the progestin hormone drug Makena® (hydroxyprogesterone caproate injection), indicated to help reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. ~~The~~As ~~Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector was approved by~~ the ~~FDA and commercialized in February 2018. We are the~~ exclusive supplier, ofwe ~~the~~perform ~~devices and the~~ final ~~assembled~~assembly and ~~packaged~~packaging of the commercial product and receive royalties on ~~AMAG~~Covis’s net sales of the product. In October ~~2019~~2020, ~~AMAG~~following ~~announced~~an ~~that~~FDA ~~the~~advisory ~~FDA’s~~committee ~~Bone~~meeting, ~~Reproductive~~Covis ~~and~~in ~~Urologic~~November ~~Drugs~~2020, ~~Advisory~~received ~~Committee~~notice ~~met~~that tothe ~~better~~FDA ~~understand~~is ~~and~~proposing ~~interpret~~to ~~the~~withdraw ~~PROLONG~~approval of Makena® (~~Progestin’s~~hydroxyprogesterone ~~Role~~caproate ininjection). ~~Optimizing~~Covis ~~Neonatal~~formally ~~Gestation)~~requested ~~confirmatory~~a ~~clinical~~public ~~trial~~hearing ~~for~~in ~~Makena®~~response ~~(hydroxyprogesterone~~to ~~caproate)~~the ~~injection.~~FDA's ~~Nine~~proposal ~~advisory~~to ~~committee~~withdraw ~~members~~its ~~voted~~approval toand has ~~recommend~~stated that it remains committed to working with the FDA ~~pursue~~to ~~withdrawal~~maintain ofpatient ~~approval~~access ~~for~~to Makena® ~~and~~as a treatment option to reduce pre-term birth.

48We are also developing with Teva a multi-dose pen for a generic form of Forteo® (teriparatide rDNA origin injection) for the treatment of osteoporosis, and were developing another multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of type 2 diabetes. On February 25, 2022, Teva notified us that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022. Teva continues to work through the U.S. regulatory process with the FDA for teriparatide using the ANDA pathway. In 2020, Teva launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s branded product Forsteo® featuring the Antares multi-dose pen used platform in several countries outside the U.S. We are responsible for the manufacturing and supply of the multi-dose pen utilized in Teva’s generic teriparatide product under an exclusive development, license and supply agreement with Teva, the scope of which is worldwide.

~~seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial.~~ In ~~October~~August ~~2020~~2018, ~~AMAG~~we ~~received~~entered ~~notice~~into ~~that~~a ~~the~~development ~~FDA~~agreement iswith ~~proposing~~Pfizer to ~~withdraw~~develop ~~approval~~a ofcombination ~~Makena®~~drug ~~(hydroxyprogesterone~~device ~~caproate~~rescue ~~injection)~~pen. ~~AMAG~~This ~~has~~rescue ~~formally~~pen ~~requested~~will autilize ~~public hearing in response to~~ the ~~FDA’s~~Antares ~~proposal~~QuickShot® auto toinjector ~~withdraw~~and ~~its~~an ~~approval~~undisclosed ~~and~~Pfizer ~~has~~drug. ~~stated~~In ~~that~~2021, itwe ~~remains~~continued ~~committed~~ to ~~working~~work ~~with~~on ~~the~~this ~~FDA~~development toprogram, ~~maintain~~and ~~patient~~we ~~access~~expect to ~~Makena®~~continue asdevelopment aof ~~treatment~~this ~~option~~product ~~to reduce pre-term birth~~candidate.

We are also collaborating with Teva on a multi-dose pen for a generic form of Forteo® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis, and another multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of type 2 diabetes. Teva continues to work through the U.S. regulatory process with the FDA for exenatide and teriparatide using the ANDA pathway. Teva recently launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s branded product Forsteo® featuring the Antares multi-dose pen platform in several countries outside the United States. Antares is responsible for the manufacturing and supply of the multi-dose pen utilized in Teva’s generic teriparatide product under an exclusive development, license and supply agreement with Teva, the scope of which is worldwide. 57

InTable August 2018, we entered into a development agreement with Pfizer to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot® auto injector and an undisclosed Pfizer drug. We are developing the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We entered into a separate commercial supply agreement with Pfizer pursuant to which we will provide fully packaged commercial ready finished product to Pfizer and Pfizer will then be responsible for commercializing the product in the U.S., pending FDA approval, for which the Company will receive royalties on net sales.Contents

In November 2019, we entered into a ~~new~~ global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. The new chemical entity selatogrel is being developed for the treatment of a suspected ~~acute myocardial infarction (~~AMI) in adult patients with a history of AMI. Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which ~~Antares~~we will provide fully assembled and labelled product to Idorsia at cost plus ~~margin~~mark-up. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. ~~Antares~~We will be entitled to receive royalties on net sales of the commercial product.

WeIn ~~are~~June ~~committed~~2021, toIdorsia ~~advancing~~announced ~~our~~it ~~internal~~had ~~research~~initiated ~~and~~its ~~development~~Phase ~~programs~~3 ~~and~~registration ~~continue~~study to ~~invest~~evaluate in the ~~development~~efficacy ~~of our proprietary product pipeline. Our research~~ and ~~development~~safety ~~efforts~~of ~~are~~self-administered ~~focused~~subcutaneous ~~primarily~~selatogrel. onThe ~~leveraging~~study ~~our~~will ~~existing~~enroll ~~product~~approximately ~~and~~14,000 ~~technology~~patients ~~platforms~~who byare ~~broadening~~at ~~their~~high ~~applications~~risk ~~for~~of ~~use~~recurrent ~~in other drug device combination products~~AMI, asat ~~well~~approximately as250 ~~exploring~~sites ~~new~~in ~~pharmaceutical~~approximately ~~products,~~30 ~~technologies and drug delivery methods~~countries.

InWe are ~~2019,~~also wecommitted ~~initiated~~to ~~development~~advancing ofour ainternal ~~proprietary~~research ~~drug~~and ~~device~~development ~~combination~~programs ~~product~~and ~~for~~continue ~~the~~to ~~urology~~invest ~~oncology~~in ~~market,~~the ~~identified as ATRS-1901. We have conducted formulation~~ development ~~work~~of ~~and~~our ~~non-clinical~~proprietary ~~studies~~product ~~to help advance this program~~pipeline. Our Inresearch ~~2020,~~and wedevelopment ~~received~~efforts aare ~~response~~focused ~~from~~primarily ~~the~~on ~~FDA~~leveraging ~~regarding~~ our ~~pre-IND~~existing ~~(Investigational~~product ~~New Drug) submission~~ and ~~believe~~technology weplatforms ~~have~~by ~~determined~~broadening ~~our~~their ~~clinical~~applications ~~and~~for ~~regulatory~~use ~~pathway~~in ~~forward. We~~other ~~expect~~drug todevice ~~file~~combination anproducts, ~~IND~~as ~~for~~well ~~this~~as ~~program~~exploring ~~with~~new ~~the~~pharmaceutical ~~FDA~~products, intechnologies ~~the~~and ~~second~~drug ~~half~~delivery ~~of 2021~~methods.

InWe ~~2019,~~have weinitiated ~~identified~~development aof ~~program to develop~~ a proprietary drug device combination product for the ~~endocrinology~~urology oncology market, identified as ATRS-~~1902. We~~1901, ~~conducted~~and ~~initial~~have conducted formulation development work and ~~developed~~non-clinical astudies ~~working prototype of a new device~~ to ~~support~~help advance this program. WeIn 2020, we received a response from the FDA regarding our pre-IND ~~submission~~(Investigational ~~and~~New ~~believe~~Drug) ~~we have determined the regulatory and clinical path forward~~submission. ~~We expect to file an IND for this program with the FDA in the first half of 2021.~~

We ~~previously~~have ~~manufactured~~identified ~~and~~a ~~sold~~program ~~reusable,~~to ~~needle-free~~develop ~~injection~~a ~~devices,~~proprietary ~~marketed~~drug ~~primarily~~device ~~through~~combination ~~Ferring~~product ~~Pharmaceuticals,~~for ~~Inc.~~the ~~and~~endocrinology ~~JCR Pharmaceuticals CO.~~market, ~~Ltd.~~an ~~for~~adrenal ~~use~~crisis ~~with~~pen, ~~human~~identified ~~growth~~as ~~hormone~~ATRS-1902. The Indevelopment ~~October~~program ~~2017,~~supports wea ~~entered~~proposed ~~into~~indication anfor ~~asset purchase agreement (~~the ~~“Asset~~treatment ~~Purchase~~of ~~Agreement”)~~acute ~~with~~adrenal ~~Ferring~~insufficiency, ~~International~~known ~~Center~~as ~~S.A.~~adrenal ~~(together~~crisis, ~~with~~in ~~Ferring~~adults ~~Pharmaceuticals Inc.~~ and ~~Ferring~~adolescents, ~~B.V.~~using ~~individually~~a ~~and~~novel ~~collectively~~proprietary ~~referred~~auto-injector toplatform ~~as “Ferring”)~~ to ~~sell~~deliver ~~the~~a ~~worldwide~~liquid ~~rights,~~stable ~~including~~formulation ~~certain~~of ~~assets~~hydrocortisone. ~~related~~We toconducted ~~the~~initial ~~needle-free~~formulation ~~auto~~work ~~injector~~and ~~device~~developed ~~product~~a ~~line~~working ~~for~~prototype ~~$14.5~~of ~~million~~a ~~(the~~new ~~“Ferring~~device ~~Transaction”)~~ to besupport ~~paid~~this toprogram. usWe inreceived ~~installments and completed over~~ a ~~two-year~~response ~~period.~~from ~~The~~the ~~transaction~~FDA ~~was~~regarding ~~completed~~our inpre-IND ~~October~~submission ~~2019,~~ and ~~with~~believe ~~the~~we ~~completion~~have ofdetermined ~~this~~the ~~transaction,~~regulatory ~~Antares~~and noclinical ~~longer~~path ~~manufactures or sells needle-free devices or components~~forward.

In July 2021, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. In January 2022, we announced the positive results from the Phase 1 clinical study and were granted Fast Track designation by the FDA. The positive results support the advancement of our ATRS-1902 development program to a pivotal clinical study for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using our Vai™ novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone. We anticipate starting this pivotal clinical study in the second quarter of 2022 and expect to submit a 505(b)(2) NDA with the FDA by the end of 2022 pending the success of the pivotal clinical study.

COVID-19

In December 2019, a novel strain of coronavirus (COVID-19) emerged in China, and has since spread worldwide, including every state in the ~~United States~~U.S. On March 11, 2020, the World Health Organization declared the outbreak a Pandemic and on March 13, 2020, the ~~United~~U.S. ~~States~~ declared a national emergency with respect to the outbreak. The Pandemic has impacted global economic activity and lead to disruptions in supply chain, labor shortages, business closures, travel restrictions and other health, safety and social distancing requirements.

49We have taken several measures to actively manage and help minimize the impact of the ongoing Pandemic on our business. We have implemented safety measures and protocols to protect the health and safety of our employees and comply with governmental and public health guidelines while working to ensure the sustainability of our business operations and continuity of product supply. We continue to monitor the situation, including COVID-19 variants, and potential effects on our business, suppliers, partners and workforce.

activity, and many countries and states have responded by instituting various quarantine, shelter-in-place or stay-at-home orders, mandating school and business closures for non-essential services and restricting travel and public gatherings. 58

~~We have~~Table ~~taken several measures to help minimize the impact~~ of the Pandemic on our business and have implemented safety measures and protocols to protect the health and safety of our employees and comply with governmental and public health regulations while working to ensure the sustainability of our business operations and continuity of product supply. We continue to monitor the situation and potential effects on our business, suppliers, partners and workforce.Contents

~~Many~~We ofhave ~~our~~implemented ~~corporate~~a ~~and~~hybrid ~~administrative~~work ~~functions~~environment ~~continue~~with the ability to ~~work~~shift ~~remotely~~remote ~~and~~as wenecessary ~~have~~to ~~limited~~limit the number of ~~staff~~individuals in our facilities to those necessary for essential functions such as research, development, manufacturing and supply. While our ~~sales~~field-based ~~force~~team has ~~been~~resumed ~~subject~~in-person tointeraction ~~varying~~with ~~limitations~~fewer ~~on their ability to physically visit physicians~~restrictions, we ~~have strategically shifted to virtual detailing and sales meetings, and are leveraging our social media presence to connect with our existing and potential customers and healthcare professionals. We~~ believe we are also well-positioned with ~~these~~our virtual capabilities to continue to ~~reach~~engage healthcare professionals and patients asthrough the ongoing Pandemic and ~~related restrictions continue to evolve~~beyond. ~~Our~~Although, ~~sales~~we ~~force~~have ~~has~~not ~~resumed~~experienced ~~in-person~~significant ~~office~~delays ~~visits~~or indisruption ~~most areas and continued virtually~~ in ~~other~~our ~~territories~~development ~~based~~programs onor ~~the~~significant ~~varying~~demand ~~restrictions,~~reductions ~~protocols~~for ~~and~~our ~~phased~~partnered ~~re-openings.~~products ~~However,~~due ~~the~~to ~~restrictions and closures during~~ the Pandemic ~~have limited or reduced patient access to physicians for non-essential services~~, ~~and~~ we ~~have~~continue ~~experienced,~~monitor ~~and~~the ~~may~~situation, ~~continue~~including toCOVID-19 ~~experience~~variants, afor ~~decrease~~potential ineffects ~~the~~on ~~rate~~our ofor ~~new prescriptions for~~ our ~~proprietary products. Our~~ partners’ ~~may~~clinical ~~also~~trials ~~experience~~or adelays ~~decrease~~ or ~~fluctuation~~disruptions in ~~demand~~activities ~~for~~with ~~our partnered products due to~~ the ~~COVID-19 Pandemic or the related restrictions~~FDA.

~~While~~Although, we have taken measures to help minimize the potential impact of the Pandemic on our business, given the fluidity of the Pandemic and ~~various~~other ~~government~~macroeconomic ~~orders~~factors, ~~and~~we ~~believe~~are ~~any potential~~unable to estimate the impact the Pandemic has had on our operations or ~~significant disruption,~~cash ~~when~~flows ~~and~~as ifof ~~experienced,~~the ~~could~~date beof ~~temporary,~~this filing. We also believe there iscontinues to be uncertainty around the timing and duration of aany potential ~~disruption,~~future disruptions due to the COVID-19 variants and the magnitude of any potential impact. As a result, we are unable to estimate the potential impact on ~~our~~ future operations or cash flows as of the date of this filing. For more information on these risks, see “Part III — Item 1A. Risk Factors — We face uncertainty and risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt our operations and may materially and adversely impact our business and financial conditions.”

Results of Operations

~~Antares~~The ~~Pharma,~~following ~~Inc.~~ is a ~~growing,~~discussion ~~revenue generating company focused on the development~~ and ~~commercialization~~analysis of ~~proprietary~~our ~~and~~financial ~~partnered pharmaceutical products and technologies. We generated record revenue of $149.6 million for the year ended December 31~~results, ~~2020~~cash ~~million~~flows, asand ~~compared~~liquidity toand ~~$123.9~~capital ~~million~~resources for the ~~year~~years ended December 31, ~~2019,~~2021 anand ~~increase of $25~~2020.7 ~~million~~A ordiscussion ~~21%. We generated record pre-tax income~~ of ~~$9.9~~changes ~~million,~~in ~~and~~our ~~recognized~~financial ~~an income tax benefit of $46.3 million~~results, ~~resulting~~cash inflow ~~net~~comparison ~~income~~ and ~~basic~~liquidity ~~earnings per share of $56.2 million~~ and ~~$0.34,~~capital ~~respectively,~~resources for the ~~year~~years ended December 31, 2020 asand ~~compared~~2019 tohas abeen ~~net~~omitted ~~loss~~from ~~and~~this ~~net~~Form ~~loss~~10-K ~~per~~but ~~share~~may ofbe ~~$2.0~~found ~~million~~in ~~and~~Item ~~$0.01,~~7 ~~respectively,~~of ~~for~~Part ~~the~~II ~~year~~of ~~ended~~our ~~December 31,~~Annual ~~2019.~~Report ~~Earnings per share~~ on aForm ~~fully~~10-K ~~diluted basis was $0.33~~ for the year ended December 31, 2020., ~~The~~filed ~~following~~with isthe aSEC ~~discussion and analysis of our results of operations~~ on aMarch ~~comparative basis for the years ended December 31~~2, ~~2020, 2019 and 2018~~2021.

~~Revenues~~Revenue, Net

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. ~~Total~~The ~~revenues~~following ~~for~~table ~~the~~provides ~~year~~details ~~ended~~about ~~December 31, 2020 increased to $149.6 million, as compared to $123.9 million for~~ the ~~year~~components ~~ended~~and ~~December~~drivers ~~31, 2019, an increase~~ of ~~$25.7~~our ~~million~~overall ~~or 21%. Total~~ revenue ~~for the year ended December 31, 2019 increased by $60.3 million or 95% as compared to $63.6 million for the year ended December 31, 2018.~~ growth:

The following table provides details about the components of our revenue (in thousands):


	Years Ended December 31,				Increased / (Decreased)
(in thousands)	2021		2020		$		%
Proprietary product sales, net	$	80,016	$	62,878	$	17,138	27.3	%
Partnered product sales	46,651		50,956		(4,305)		(8.4)	%
Total product revenue, net	126,667		113,834		12,833		11.3	%
Licensing and development revenue	19,623		14,466		5,157		35.6	%
Royalties	37,692		21,299		16,393		77.0	%
Total revenue, net	$	183,982	$	149,599	$	34,383	23.0	%

	For the Years Ended December 31,
	2020		2019		2018
Proprietary product sales	$	62,878	$	39,215	$	17,532
Partnered product sales		50,956		52,888		30,338
Total product revenue		113,834		92,103		47,870
Licensing and development revenue		14,466		7,529		6,753
Royalties		21,299		24,232		8,931
Total revenue	$	149,599	$	123,864	$	63,554

Product Revenue, Net

50Net revenue from product sales increased 11.3% primarily due to increased sales of our proprietary products XYOSTED® and NOCDURNA® and partnered sales of OTREXUP® to Otter subsequent to sale of the product line, partially offset by a reduction in sumatriptan sales to Teva and sales of Makena® subcutaneous auto-injectors to Covis.

~~Product~~Sales ~~Revenue~~of our proprietary products are presented net of estimated product returns and sales allowances. The OTREXUP® product line was sold to Otter in December 2021 with a supply agreement executed simultaneously; therefore, all revenue generated prior to the date of sale is included in proprietary product sales and all revenue generated subsequent to the date of sale is included in partnered products sales. The increase in propriety product sales of 27.3% was primarily attributable to continued growth in prescriptions and sales of XYOSTED®, which we launched for commercial sale in 2018, and sales of NOCDURNA®, which we in-licensed and began detailing in the fourth quarter of 2020, partially offset by a reduction in sales of OTREXUP® due to the sale of the product line to Otter in December 2021. We attribute this growth to successful marketing and launch strategies, achieving and maintaining targeted reimbursement coverage, and our ability to leverage our virtual sales capabilities to support the continued growth despite any potential softening or impact due to the global Pandemic in 2021 and 2020.

Revenue from product sales was $113.8 million, $92.1 million, and $47.9 million for the years ended December 31, 2020, 2019, and 2018, respectively. The increases in product revenue were driven principally by sales of recently approved and launched products, both proprietary and partnered, as discussed below.59

~~Proprietary~~Table ~~Product~~of ~~Sales~~Contents

~~Sales~~We ofalso ~~our~~manufacture ~~proprietary products, which are presented net of estimated product returns~~ and ~~sales~~sell ~~allowances~~devices, ~~generated~~components ~~revenue of $62.9 million, $39.2 million~~ and ~~$17.5~~fully ~~million~~assembled ~~for~~packaged ~~the~~product ~~years~~to ~~ended~~our ~~December~~partners 31Teva, ~~2020,~~Covis ~~2019,~~ and ~~2018, respectively~~Otter. ~~The~~Partnered ~~significant increases in our proprietary~~ product sales ~~for~~decreased ~~the~~by ~~year~~8.4% ~~ended~~due ~~December 31, 2020 as compared~~ to ~~2019~~a ~~and~~decrease ~~2018~~in ~~were~~sumatriptan ~~principally~~sales ~~attributable~~ to ~~sales of XYOSTED®~~Teva, ~~which~~lower weproduction ~~launched for commercial sale in late 2018. Prescriptions~~ and sales volumes of ~~XYOSTED~~Makena® ~~grew steadily in 2019 and continued~~ to ~~grow~~Covis ~~significantly in 2020, resulting in an increase in revenue of 124% in 2020 as compared to 2019. We attribute this growth to successful marketing~~ and ~~launch~~a ~~strategies,~~decrease ~~achieving and maintaining targeted reimbursement coverage, and our ability to leverage our virtual sales capabilities to support the continued growth~~ in ~~year~~shipments ~~two~~ of ~~launch~~epinephrine ~~despite~~auto ~~any~~injectors ~~potential softening or impact due~~ to ~~the global Pandemic. Revenue from proprietary products sales for the year ended December 31~~Teva, ~~2018~~partially ~~was~~offset ~~principally~~by ~~attributable to sales of OTREXUP®. Net~~ revenue generated from ~~sales~~production of OTREXUP® ~~decreased~~for byOtter ~~16% in 2020 compared to 2019~~ and ~~increased~~higher byteriparatide 9%sales ~~in 2019 as compared~~ to ~~2018~~Teva.

Partnered Product Sales

We manufacture and sell devices, components, and fully assembled packaged product to our partners Teva, AMAG and formerly Ferring. Partnered product sales were $51.0 million, $52.9 million and $30.3 million for the years ended December 31, 2020, 2019, and 2018, respectively. The slight net decrease in sales of partnered products for the year ended December 31, 2020 as compared to 2019 was attributable to a decrease in sales of Makena® auto-injectors to AMAG, a decrease in sales of needle-free devices due to the completion of the Ferring Transaction in 2019, and a reduction in sales of pre-launch quantities of teriparatide pen devices sold to Teva in previous periods in anticipation of a potential launch. These decreases were offset by a 57% increase in sales of auto injector devices to Teva for use with their generic Epinephrine Injection USP products. The increase in partnered product sales for the year ended December 31, 2019 compared to 2018 was primarily attributable to an increase in sales of auto injector devices to Teva in connection with the launch of generic Epinephrine Injection USP.

Licensing and Development Revenue

Licensing and development revenues include license fees received from partners for the right to use our intellectual property and amounts earned in joint development arrangements with partners under which we perform development activities or develop new products on their behalf. Fluctuations in our licensing and development revenue are generally attributable to the development timelines of our various partnered development projects, the timing of which is often controlled by our partner, and the timing of achievement of certain milestones. ~~Licensing and development revenue was $14.5 million, $7.5 million and $6.8 million for the years ended December 31, 2020, 2019 and 2018, respectively.~~

~~The~~Licensing ~~increase~~and in development revenue ~~for~~increased ~~the~~35.6% ~~year~~primarily ~~ended December 31, 2020,~~ as ~~compared to 2019 was primarily~~ a result of ~~the~~incremental ~~new~~ development ~~project~~and ~~with~~maintenance ~~Idorsia~~activities ~~that~~with ~~was~~Teva ~~announced~~to insupport ~~the~~replacement ~~fourth quarter~~ of ~~2019,~~molds ~~an increase in ongoing development activities with Pfizer,~~ and ~~other~~tooling ~~partnered~~related ~~development~~to ~~projects, offset by a reduction in revenue from~~ the ~~development~~commercial production of the ~~Teva~~epinephrine ~~teriparatide~~auto ~~pen,~~injector ~~which has now been launched in Europe. In 2019, licensing~~ and ~~development~~continuing ~~revenue was primarily attributable to our~~ development activities ~~with~~under ~~Pfizer~~other ~~for~~ongoing ~~the~~partnered development ~~of a new rescue pen product~~projects, ~~and~~partially ~~with~~offset ~~Teva,~~by ~~primarily~~a decline in ~~connection~~development activities with ~~the teriparatide pen injector project~~Pfizer.

For the year ended December 31, 2018 a majority of our licensing and development revenue was primarily attributable to development services provided to Teva in connection with the pen injector projects for generic versions of Forteo® and Byetta®, continued development work for AMAG, and a $2.0 million milestone payment received from Teva in connection with the FDA approval of Teva’s epinephrine auto injector product in August 2018.

Royalties

WeRoyalties ~~earn~~are ~~royalties~~earned in connection with licenses granted to our partners under license and development arrangements. Royalties are generally based upon a percentage of our partners’ net sales of the partnered product. Royalty ~~revenues~~revenue ~~were~~increased ~~$21~~77.30% ~~million,~~primarily ~~$24.2~~due ~~million~~to ~~and~~an ~~$8.9~~increase ~~million~~in ~~for~~royalties ~~the~~from ~~years~~Teva ~~ended~~on ~~December 31,~~its ~~2020,~~net ~~2019~~sales ~~and~~of ~~2018,~~generic ~~respectively~~EpiPens®.

51Cost of Revenue

The ~~net~~following ~~decrease~~table insummarizes ~~royalty~~our ~~revenue~~cost ~~for the year ended December 31, 2020 compared to 2019 was primarily a result~~ of aproduct ~~decrease in royalties from AMAG on their net~~ sales ~~of the Makena® subcutaneous auto injector,~~ and adevelopment ~~decrease in royalties from Ferring on their needle-free sales, offset by an increase in royalties from Teva on their net sales of Epinephrine Injection USP. The significant increase in royalty~~ revenue for the year ended December 31, 2019 as compared to 2018 was primarily attributable to royalties received from Teva on its net sales of Epinephrine Injection USP, which was launched in late 2018, and an increase in royalties received from AMAG on its net sales of the Makena® subcutaneous auto injector. :

Cost of Revenues


	Years Ended December 31,						Increased / (Decreased)
(in thousands)	2021			2020			$		%
Cost of product sales	$	54,418		$	53,960		$	458	0.8	%
Cost of development revenue	13,863			9,140			4,723		51.7	%
Total cost of revenue	$	68,281		$	63,100		$	5,181	8.2	%
% of revenue	37.1		%	42.2		%

~~The~~Fluctuations ~~following~~in ~~table~~cost ~~summarizes~~of ~~our~~product sales is generally a function of the product revenue mix. Proprietary products generally have a lower cost of sales as a percentage of revenue than partnered product sales. ~~and~~The year-over-year increase in cost of development revenue (is attributable to and relatively consistent with the growth in ~~thousands):~~development revenue from partnered development activities.

	For the Years Ended December 31,
	2020		2019		2018
Cost of product sales		53,960		46,267		29,094
Cost of development revenue		9,140		4,208		1,971
Total cost of revenue	$	63,100	$	50,475	$	31,065

The year over year increases in our cost of revenue is attributable to and consistent with the significant growth in product sales and revenue from partnered development activities.

Research and Development Expenses

Research and development (“R&D”) expenses ~~include~~consist ~~costs~~of ~~incurred~~external incosts ~~connection~~for ~~with~~ clinical studies and analysis activities, formulation development, engineering design work and prototype development, ~~personnel costs,~~ FDA ~~filing~~application fees, personnel costs and other ~~quality,~~general ~~regulatory~~operating ~~and~~expenses ~~overhead costs~~ associated with our research and development ~~programs~~activities. Research and development costs were attributable to our ongoing internal development programs including, but not limited to, ATRS-1901 and ATRS-1902, and fluctuate based on the respective phases of development. Research and development expenses were $10.1 million, $10.6 million and $12.3 million for the years ended December 31, 2020, 2019 and 2018, respectively.

The decrease in research and development costs incurred in 2020 as compared to 2019 was due to shifts in timing of clinical studies that are now anticipated to begin in 2021 and the discontinuation of the ATRS-1701 program for which we ceased development in 2019. The decrease in research and development expenses for the year ended December 31, 2019 compared to 2018 was primarily a result of a decrease in development costs related to XYOSTED®, which was approved by the FDA on September 28, 2018 and is now a marketed product.


	Years Ended December 31,				Increased / (Decreased)
(in thousands)	2021		2020		$		%
Research and development	$	14,502	$	10,121	$	4,381	43.3	%

R&D expenses increased 43.3% primarily due to our ongoing internal development programs including ATRS-1902 and ATRS-1901, along with higher employee compensation expense. Overall, R&D expense fluctuates based on phases of development and timing of clinical studies, including internal and external development costs incurred. As discussed above, we further advanced our ATRS-1902 development program with positive result from a Phase 1 clinical study for adrenal crisis rescue in January 2022 and were granted Fast Track designation by the FDA. The results support the advancement of our ATRS-1902 development program to a pivotal clinical study which we anticipate starting in the second quarter of 2022.

Table of Contents

Selling, General and Administrative

Selling, general and administrative expenses were $62.8 million, $61.8 million and $36.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. The net increase in selling, general and administrative expenses for the year ended December 31, 2020 as compared to 2019 was due to an increase of 17% in general and administration expenses, primarily from increases in payroll and equity-based compensation costs and additional increased overhead costs of our new facility, offset by a 5% reduction in sales and marketing costs incurred as a result of the various stay at home orders and travel restrictions imposed due to the COVID-19 Pandemic.


	Years Ended December 31,				Increased / (Decreased)
(in thousands)	2021		2020		$		%
Selling, general and administrative	$	73,857	$	62,759	$	11,098	17.7	%

~~The increase in selling~~Selling, general and administrative expenses ~~for~~increased ~~the~~17.7% ~~year~~primarily ~~ended~~due ~~December~~to ~~31,~~higher ~~2019~~sales asand ~~compared~~marketing tocosts ~~2018~~associated ~~was~~with ~~principally~~the ~~attributable~~relaunch toof ~~the~~NOCDURNA®, ~~launch~~which we in-licensed and ~~commercialization~~began ofdetailing ~~XYOSTED®.~~in ~~Sales~~the ~~and~~fourth ~~marketing~~quarter ~~expenses~~of ~~nearly~~2020. ~~doubled~~The inincrease ~~2019~~is ~~principally~~also attributable to anhigher ~~increase~~sales inand ~~compensation~~marketing costs ~~and~~associated ~~new~~with ~~facility~~XYOSTED®, ~~overhead~~which ~~related~~were todown ~~the~~in ~~expansion~~2020 ofdue to the ~~sales~~Pandemic ~~force~~as inthe ~~late~~various ~~2018~~restrictions and ~~other~~limitations ~~expenses~~imposed ~~associated~~during ~~with~~ the ~~marketing~~Pandemic ofled ~~XYOSTED®.~~to Indecreased ~~addition,~~spending ~~general~~that ~~and~~has ~~administrative~~returned ~~costs~~to ~~increased~~pre-Pandemic bylevels, ~~approximately~~along ~~25%~~with tohigher ~~support~~employee ~~the~~compensation. ~~overall~~General ~~business~~and ~~growth,~~administrative expenses also increased primarily driven by ~~increases~~higher in professional ~~services~~service fees, ~~business~~facility ~~insurance~~costs, ~~legal~~insurance ~~fees~~expense and ~~stock-based~~employee compensation. costs to support the continued growth of the business.

~~Income~~Gain ~~Tax~~on ~~Benefit~~Sale

~~For~~In ~~the year ended~~ December 312021, ~~2020,~~ we ~~recorded~~sold ancertain ~~income~~assets ~~tax~~used ~~benefit~~in the operation of ~~$46.3~~the ~~million~~OTREXUP® onproduct ~~pre-tax~~to ~~income~~Otter offor $944.90 million., ~~The~~subject ~~large~~to ~~income~~finalization ~~tax~~of ~~benefit~~changes ~~recognized~~in ~~for~~closing ~~the~~inventory ~~year~~to ~~ended~~be ~~December 31~~transferred, ~~2020~~with ~~was~~$18.0 ~~primarily~~million areceived ~~result~~at ofclosing ~~the~~and ~~release~~an ofadditional ~~the Company’s valuation allowance on its deferred tax assets~~$26.0 Asmillion ofto ~~December~~be ~~31,~~paid ~~2020,~~in ~~management~~installments ~~concluded~~over ~~that, as~~ a ~~result~~one-year ofperiod. ~~generating~~The ~~pre-tax~~gain ~~earnings,~~on ~~utilization~~sale of ~~net~~assets ~~operating~~of ~~loss~~$38.6 ~~carryovers~~million ~~and~~represents ~~future~~the ~~projected~~purchase ~~pre-tax~~price ~~earnings,~~adjusted itfor isestimated ~~more~~changes ~~likely~~in ~~than~~closing ~~not~~inventory ~~that~~to ~~its deferred taxes are realizable and may~~ be ~~utilized~~transferred toless ~~offset~~net ~~future~~book ~~tax~~value ~~liabilities.~~of ~~Additional information can be found in~~ the ~~section~~assets ~~below~~sold ~~entitled “Critical Accounting Policies~~ and ~~Estimates”~~direct ~~and~~transaction ~~in Note 13 – Income Taxes to the Consolidated Financial Statements in Part II, Item 8~~costs.

52Income Tax Expense (Benefit)

Net Income (Loss) and Net Income (Loss) Per Share


	Years Ended December 31,						Increased / (Decreased)
(in thousands)	2021			2020			$		%
Income tax provision (benefit)	$	15,982		$	(46,280)		$	62,262	134.5	%
Effective tax rate	25.7		%	(466.5)		%

InIncome ~~2020,~~tax weexpense ~~posted~~recorded ~~our~~for ~~first~~the ~~annual~~year ~~period~~ended ofDecember ~~profitability~~31, ~~generating~~2021 ~~pre-tax~~was ~~net~~driven ~~income~~by ofthe ~~$9.9~~generation ~~million~~of ~~and~~income ~~net~~before income taxes of $5662.23 million ~~for the year ended December 31~~, ~~2020~~resulting asin ~~compared~~an toeffective ~~net~~tax ~~losses~~rate of $225.07%. ~~million~~The ~~and~~effective ~~$6.5~~tax ~~million~~rate ~~for~~is ~~the~~primarily ~~years~~driven ~~ended~~by ~~December~~the ~~31,~~federal ~~2019~~ and ~~2018,~~state ~~respectively.~~tax Werates, ~~reported~~along ~~basic~~with ~~net~~discrete income ~~per~~tax ~~share~~items offor $0compensation expense.34 ~~for~~For the year ended December 31, 2020, aswe ~~compared~~recorded toan aincome ~~net~~tax ~~loss~~benefit ~~per share~~ of $046.013 ~~and~~million on pre-tax income of $09.049 ~~for~~million ~~the~~primarily ~~years~~due ~~ended~~to ~~December~~the ~~31,~~release ~~2019~~of ~~and~~our ~~2018,~~valuation ~~respectively.~~allowance ~~Earnings~~on ~~per~~our ~~share~~deferred ontax aassets ~~fully~~which ~~diluted~~favorably ~~basis~~impacted ~~was~~our ~~$0.33~~effective ~~for~~tax ~~the~~rate. ~~year~~As ~~ended~~of December 31, 2020., ~~This~~we ~~profitability~~concluded ~~was~~that, ~~achieved~~as ina ~~2020~~result ~~due~~of togenerating ~~the~~pre-tax ~~significant~~earnings, ~~increase~~utilization ~~in sales~~ of ~~newly~~net ~~commercialized~~operating ~~proprietary~~loss ~~products,~~carryovers ~~new~~ and ~~continued~~future ~~partnered~~projected ~~development~~pre-tax ~~activities~~earnings, ~~controlled~~it ~~spending,~~is ~~and~~more ~~also~~likely ~~included~~than ~~the~~not ~~recognition~~that ofits adeferred ~~$46.3~~taxes ~~million~~are ~~tax~~realizable ~~benefit~~and asmay abe ~~result~~utilized ofto offset future tax liabilities. Excluding the ~~company~~release ~~releasing~~of ~~its~~our valuation allowance on ~~its~~our deferred tax assets., ~~The~~the ~~reduction~~effective intax ~~our~~rate ~~net loss and net loss per share~~ for the year ended December 31, ~~2019~~2020 aswould ~~compared~~have tobeen ~~2018~~higher ~~was~~than ~~primarily~~the aeffective ~~result~~tax ofrate ~~our~~for ~~significant~~the ~~growth~~year inended ~~revenues~~December ~~from~~31, ~~product~~2021 ~~sales~~primarily ~~and~~due ~~royalties~~to ~~offset~~the byimpact anof ~~increase~~permanent intax ~~our~~items ~~selling,~~on ~~general~~a ~~and~~lower ~~administrative~~income ~~expenses.~~before income taxes.

Net Income and Earnings Per Common Share


	Years Ended December 31,				Increased / (Decreased)
(in thousands, except per share amounts)	2021		2020		$		%
Net income	$	46,289	$	56,201	$	(9,912)	(17.6)	%

Earnings per common share
Basic	$	0.27	$	0.34	$	(0.07)	(20.6)	%
Diluted	$	0.26	$	0.33	$	(0.07)	(21.2)	%

Table of Contents

Liquidity and Capital Resources

AtAs of December 31, ~~2020~~2021 we had cash and cash equivalents of $5365.19 million. We believe that the combination of our current cash and cash equivalents, along with our projected product sales, development revenue and royalties will provide us with sufficient funds to meet our obligations, including debt maturities, and support operations through at least the first quarter of ~~2022~~2023. We reported net income ~~of $56.2 million,~~ and positive cash flows from operations for the ~~year ended December 31, 2020 compared to net losses of $2.0 million and $6.5 million, and negative cash flows from operations for the~~ years ended December 31, ~~2019~~2021 and ~~2018, respectively~~2020. We had an accumulated deficit atas of December 31, ~~2020~~2021 of $~~222~~176.63 million. Prior to 2020, we ~~have~~had not historically generated enough operating cash flow to support our operations and ~~have~~ funded our operations ~~though~~through equity offerings and debt issuance.

If additional capital is needed to support our operations ~~or growth~~ in the future, we may need to raise additional funds through ~~financings~~financing, such as ~~the~~drawing our current credit facility, issuance of additional debt, equity or notes convertible into our common stock. However, we may be unable to obtain such financing, or obtain it on favorable terms, in which case we may be required to curtail development of new products, limit expansion of operations or accept financing terms that are not as attractive as we may desire.

Long-~~Term~~term Debt Financing

~~The~~As ~~Company~~of isDecember 31, 2020, we were party to a loan and security agreement, as amended, with Hercules Capital, Inc., ~~for a term loan~~ (the “Term Loan”)~~, under which the Company has borrowed $40~~.0 ~~million.~~ The amortizing Term Loan iswas secured by substantially all of ~~the~~our ~~Company’s~~ assets, excluding intellectual property, ~~accrues~~and accrued interest at a prime-based variable rate with a maximum of 9.5%, which was 8.5% atin ~~December~~2021. ~~31,~~In ~~2020~~2021, ~~provides~~we ~~for~~made ~~payments~~principal prepayments of ~~interest-only~~$20.0 ~~until~~million ~~August~~and paid a 1.0% prepayment fee. On November 1, 2021, we extinguished the Loan Agreement with Hercules Capital, Inc. and ~~matures~~repaid the outstanding $20.0 million principal on ~~July 1,~~the ~~2022~~Term Loan, ~~which~~along ~~may~~with bea ~~extended~~1.0% toprepayment ~~July~~fee 1,and ~~2024~~the ~~contingent~~end ~~upon~~of ~~satisfaction~~term charge of a$1.7 ~~certain~~million. ~~loan~~All ~~extension~~remaining ~~milestone~~unamortized debt issuance costs associated with the Term Loan were immediately amortized to interest expense.

~~The~~On ~~interest-only~~November ~~payment~~1, ~~period~~2021, ofwe ~~the~~entered ~~Term~~into ~~Loan~~a ~~may~~Credit ~~also~~Agreement be(the ~~extended~~“Credit toAgreement”) ~~August~~with 1,Wells ~~2022~~Fargo ifBank, ~~the~~National ~~Company~~Association, ~~achieves~~as aadministrative ~~certain~~agent ~~loan~~for ~~extension~~the ~~milestone~~lenders, ~~requests~~for ~~such~~credit ~~extension,~~facilities ~~and~~in ~~pays~~ an ~~extension~~aggregate ~~fee~~principal ~~equal~~amount of up to ~~one~~$40.0 ~~half~~million ofwith ~~one~~a ~~percent~~maturity date of ~~the~~November ~~principal~~1, ~~amount outstanding~~2024. The ~~Company~~Credit isAgreement ~~required~~consists toof ~~pay~~a an$20.0 ~~end~~million of term ~~fee~~loan ~~equal~~facility to(the ~~4.25%~~“Term ofLoan ~~the~~Facility”) ~~first~~and a $2520.0 million ~~and~~revolving ~~3.95%~~credit offacility ~~all~~(the ~~other~~“Revolving ~~borrowings~~Credit ~~under~~Facility”), (collectively the ~~loan~~“Credit Facilities”), ~~payable~~which are secured by substantially all of our assets. The Term Loan Facility was funded upon execution of the ~~earlier~~Credit ofAgreement ~~July~~with 1the proceeds used to repay our $20.0 million Term Loan with Hercules Capital, ~~2022~~Inc. orand ~~repayment~~to ofpay fees and expenses incurred in connection with the ~~loan~~early repayment.

Total interest-bearing debt as of December 31, 2021 was $20.0 million and we had $20.0 million of unused borrowing capacity on our Revolving Credit Facility, which is expected to be used for ongoing working capital requirements and other general corporate purposes as needed. Commitment fees are payable on the unused portion of the Revolving Credit Facility at rates between 0.30% and 0.45% based on our Consolidated Total Leverage Ratio, as defined in the Credit Agreement, remeasured quarterly. Payments under the Term Loan Facility are due in consecutive quarterly installments on the last business day of each of March, June, September and December, commencing on March 31, 2022. At our election, interest accrues at LIBOR plus the ~~Market~~applicable ~~Common~~margin ~~Stock~~ranging ~~Offering~~from ~~Program~~2.25% to 3.00%, which varies based on our Consolidated Total Leverage Ratio. The new Credit Facilities, which replaced the previous Term Loan, are expected to provide approximately $1.2 million in annual interest expense savings based on an interest rate of approximately 2.60% (one-month LIBOR rate plus the applicable margin of 2.50%) as of December 31, 2021.

InUnder ~~August~~the ~~2017~~Credit Agreement, we ~~entered~~are ~~into~~subject ato ~~sales~~customary ~~agreement~~affirmative ~~(the~~and ~~“Sales~~negative ~~Agreement”)~~covenants, ~~with~~including, ~~Cowen~~among ~~and Company~~others, ~~LLC~~restrictions ~~(“Cowen”)~~on ~~under~~our ~~which~~ability weto ~~could~~incur ~~offer~~debt; ~~and~~create ~~sell~~liens; make investments; merge, ~~from~~consolidate ~~time~~or todispose ~~time~~of ~~and~~assets ator ~~our~~subsidiaries; ~~sole~~enter ~~discretion~~into transactions with affiliates; modify accounting practices, ~~shares~~our year end and organizational documents; pledge assets; revise nature of ~~our~~business; ~~common~~perform ~~stock~~sale ~~having~~leasebacks; anand ~~aggregate~~enter ~~offering~~into ~~price~~any restrictive agreements and customary events of updefault to(including ~~$30.0~~payment ~~million~~defaults, ~~through~~covenant ~~Cowen~~defaults, aschange ~~the~~of ~~sales~~control ~~agent~~defaults and~~/or~~ asbankruptcy ~~principal~~defaults). ~~Cowen~~The ~~was~~Credit ~~permitted~~Agreement toalso ~~sell~~contains financial covenants, including the ~~common~~ratio ~~stock~~of ~~through~~consolidated ~~any~~total ~~method~~indebtedness ~~deemed~~to anconsolidated earnings before income, taxes, depreciation and amortization (“atConsolidated ~~the~~EBITDA”) ~~market~~(“Consolidated ~~offering~~Total Leverage Ratio”), as defined in ~~Rule 415~~the ofCredit ~~the~~Agreement” ~~Securities~~and ~~Act~~the ratio of ~~1933~~consolidated senior secured indebtedness to Consolidated EBITDA (“Consolidated Senior Secured Leverage Ratio”), as ~~amended~~well (as the ratio of Adjusted EBITDA to consolidated fixed charges (“~~ATM~~Consolidated ~~Facility~~Fixed Charge Coverage Ratio”), as defined in the Credit Agreement. ~~Cowen~~These ~~was~~covenants ~~entitled~~restrict our ability to ~~receive~~purchase aoutstanding ~~commission~~shares of 3our common stock.0% As of ~~the~~December ~~gross~~31, ~~sales~~2021, ~~proceeds~~we ofwere ~~any~~in ~~common~~compliance ~~stock~~with ~~sold~~all ~~under~~affirmative, ~~the~~negative ~~Sales~~and ~~Agreement.~~financial covenants.

WeSee ~~sold~~Note ~~2.3~~8 ~~million~~to ~~and 2.1 million shares of common stock under~~ the ~~ATM~~Consolidated ~~Facility~~Financial ~~during~~Statements ~~the~~included ~~years ended December 31, 2019 and 2018, respectively. The sale of common stock resulted~~ in ~~aggregate~~Item ~~gross proceeds of $~~8.1 ~~million and $7.6 million, less sales commission and payment~~ of ~~offering~~Part ~~costs,~~II ~~resulting in net offering proceeds to the Company~~ of ~~$7.8~~this ~~million~~Annual ~~and~~Report ~~$7.1~~on ~~million~~Form in10-K ~~2019~~for ~~and 2018, respectively. On June 26, 2019, the Company delivered written notice to Cowen that it was terminating its Sales Agreement effective July 6, 2019, and accordingly no~~ additional ~~sales~~information ~~have~~on ~~been~~our orfinancing ~~will be made under the ATM Facility~~arrangements.

~~Net Cash Flows from Operating Activities~~62

~~Operating~~Table ~~cash inflows are generated primarily from product sales, license and development fees and royalties. Operating cash outflows consist principally~~ of expenditures for manufacturing costs, sales and marketing activities, personnel costs, external research and development costs, general and administrative costs and payment of interest on borrowings. Net cash provided by operating Contents

53Cash Flow Comparisons

activities was $21.3 million, for the year ended December 31, 2020 as compared to net cash used in operating activities of $10.6 million and $17.3 million for the years ended December 31, 2019 and 2018, respectively. Net operating cash provided by operations is a function of the net income of $56.2 million, for the year ended December 31, 2020, adjusted for noncash items including the recognition of income tax benefit, stock compensation and other non-cash expenses, and changes in operating assets and liabilities. The ~~prior~~following ~~year~~table ~~net~~summarizes ~~losses~~our ~~of $2.0 million and $6.5 million for the years ended December 31, 2019 and 2018, respectively, contributed to the net~~ cash ~~used in operations. Our reconciliation of net income or loss to operating cash flow is significantly affected by the timing of operating expenditures and cash receipts.~~ flows:

Net Cash Flows from Investing Activities


	Years Ended December 31,
(in thousands)	2021		2020
Total cash provided by (used in):
Operating activities	$	36,619	$	21,320
Investing activities	(3,852)		8,167
Financing activities	(19,990)		447
Effect of exchange rate changes on cash	(1)		2
Increase (decrease) in cash and cash equivalents	12,776		29,936
Cash and cash equivalents, beginning of period	53,137		23,201
Cash and cash equivalents, end of period	$	65,913	$	53,137

~~Net~~Operating cash provided by investing activities was $8.2 million for the year ended December 31, 2020 as compared to $20 million used in investing activities for the year ended December 31, 2019. The net cash provided by investing activities for the year ended December 31, 2020 was attributable to $22.5 million proceeds from maturities of investments offset by payments for capital expenditures and the purchases of intangible product rights.Activities

InOperating ~~2019, net~~ cash ~~used~~inflows inare ~~investing~~generated ~~activities~~primarily ~~was~~from anet ~~result~~product ofsales, ~~the~~license ~~purchase~~and ofdevelopment ~~investment~~fees ~~securities of $22.6 million~~ and ~~capital expenditures of $2~~royalties.4 Operating ~~million,~~cash ~~partially~~outflows ~~offset~~consist byprincipally ~~the receipt~~ of ~~the~~expenditures ~~$5.0~~for ~~million~~manufacturing ~~final~~costs, ~~installment~~personnel incosts, ~~connection~~general ~~with~~and ~~the~~administrative ~~completion~~expenses, ofresearch ~~the~~and ~~Ferring~~development ~~Transaction. For the year ended December 31~~activities, ~~2018~~and ~~net~~sales ~~cash~~and ~~inflow~~marketing ~~was attributable to the receipt of $7~~costs.5 ~~million~~Fluctuations in ~~connection~~cash ~~with~~from ~~the~~operating ~~Ferring~~activities ~~Transaction~~are ~~and~~primarily ~~proceeds~~a ~~from~~result ~~maturities~~ of ~~investments~~the timing of ~~$5.0~~cash ~~million~~receipts ~~offset by payments for capital expenditures~~ and ~~patent rights~~disbursements.

~~Net~~The ~~Cash~~change ~~Flows~~in the net cash from ~~Financing~~operating ~~Activities~~activities was primarily a result of the increase in our net income, excluding non-cash activity, and changes in operating assets and liabilities due to timing of cash receipts and cash disbursements, principally driven by depletion of inventory and an increase in accrued liabilities, partially offset by an increase in accounts receivable and deferred revenue.

~~Net~~Investing ~~cash provided by financing activities was $0.4 million, $25.9 million and $7.0 million for the years ended December 31, 2020, 2019 and 2018, respectively.~~ Activities

~~The~~Net ~~net~~ cash ~~flow~~used ~~from~~in ~~financing~~investing activities ~~was $0.4 million~~ for the year ended December 31, ~~2020~~2021 ~~and~~was ~~consisted~~attributable to the purchase of TLANDO® intangible product rights for $111.83 million, incapital ~~proceeds~~expenditures ~~from~~of ~~the~~$6.7 ~~exercise~~million, an additional NOCDURNA® intangible product rights contractual payment of ~~stock~~$2.5 ~~options~~million ~~offset~~and byinvestment security purchases of $1.42 million, ~~paid~~partially tooffset ~~taxing~~by ~~authorities~~net inproceeds ~~connection~~of ~~with~~$17.8 ~~net-share~~from ~~settled~~the ~~stock-based~~sale ~~awards~~of the OTREXUP® product line. Net cash provided by investing activities for ~~which~~the weyear ~~withheld~~ended ~~shares~~December ~~equivalent~~31, 2020 was attributable to ~~the~~$22.5 ~~value~~million proceeds from maturities of ~~the~~short-term ~~employees’~~investments, ~~tax~~partially ~~obligation~~offset by capital expenditures of $9.6 million primarily for ~~the~~our ~~applicable~~manufacturing ~~income~~facility and ~~other~~the ~~employment~~purchase ~~taxes~~of NOCDURNA® intangible product rights for $5.0 million.

InFinancing 2019, we received $15.0 million in new debt proceeds from borrowing under our Term Loan and paid $0.1 million in debt issuance costs. We also raised $7.8 million in net offering proceeds from the ATM facility and generated cash proceeds of $4.4 million from the exercise of stock options. We paid $1.1 million to taxing authorities in connection with net-share settled awards for which we withheld shares equivalent to the value of the employees’ minimum statutory obligation for the applicable income and employment taxes. Activities

~~For~~Net cash used in financing activities for the year ended December 31, ~~2018,~~2021 weconsisted ~~raised~~of $740.10 million in ~~net~~principal ~~offering~~payments ~~proceeds~~on the extinguishment of our Term Loan with Hercules Capital, Inc., $2.8 million paid to taxing authorities in connection with net-share settled share-based awards for which we withheld shares equivalent to the ~~ATM~~value ~~facility~~of the employee’s tax obligation for the applicable income and other employment taxes, $2.1 million in prepayment fees and an end of term charge on our Term Loan and $0.3 million in debt issuance costs, partially offset by $20.0 million in proceeds from the issuance of our new Term Loan Facility with Wells Fargo and $5.2 million in proceeds received from exercises of stock options. Net cash provided by financing activities for the year ended December 31, 2020 included $1.8 million in proceeds from the exercise of stock options, partially offset by $01.54 million ~~remitted~~paid to taxing authorities in connection with net-share settled stock-based awards for which we withheld shares equivalent to the value of the employees’ ~~minimum~~tax ~~statutory~~ obligation for the applicable income and other employment taxes.

Table of Contents

Contractual Obligations

~~The~~As ~~following~~of ~~table~~December ~~presents~~31, 2021, our contractual obligations ~~and~~are ~~the related payments, including interest, due by period~~ as ~~of December 31, 2020 (in thousands)~~follows:

	~~Payments Due by Period~~	Payments Due by Period
				Less than			1 - 3		3 - 5			More than
(in thousands)		Total				Less than1 year				1 - 3years				3 - 5years		More than5 years
	Total			1 year			years		years			5 years
Long-term debt obligations 1		$	20,000			$	1,500			$	18,500			$	—	$	—
Long-term debt obligations	$	41,655		$	16,230		$	25,425	$	—		$	—
Interest payable on long-term debt 2		1,350				512				838				—		—
Operating lease obligations		8,984			1,538			1,831		1,344			4,271
Unused revolving line of credit fee 3		201				71				130				—		—
Purchase commitments		31,005			31,005			—		—			—
Operating lease obligations 4		8,012				1,334				1,731				1,354		3,593
Total	$	81,644		$	48,773		$	27,256	$	1,344		$	4,271
Purchase commitments 5		31,312				31,312				—				—		—
Total		$	60,875			$	34,729			$	21,199			$	1,354	$	3,593

1 Long-term debt includes principal installment payments on our Term Loan. Refer to Note 8 to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K for additional information regarding our financing arrangements.

2 Calculated using the variable interest rate as of December 31, 2021 based on LIBOR plus required spread on our Term Loan. Refer to Note 8 to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K for additional information regarding our financing arrangements.

3 Calculated using the commitment fee rate as of December 31, 2021 based on our consolidated total leverage ratio assuming the entire revolving line of credit remains undrawn for the duration of the agreement. Refer to Note 8 to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K for additional information regarding our financing arrangements.

4 Operating leases are primarily for office space, as well as vehicles and equipment. Refer to Note 5 to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K for additional lease information.

5 Purchase commitments include open purchase orders with suppliers and inventory to be purchased in accordance with the TLANDO® exclusive license agreement entered into with Lipocine in October 2021. Refer to Note 6 to the Consolidated Financial Statements included in Item 8 of Part II of this Annual Report on Form 10-K for additional information on the agreement.

Off Balance Sheet Arrangements

WeAs doof December 31, 2021, we did not have any off-balance sheet arrangements, including any arrangements with any structured finance, special purpose or variable interest entities.

Critical Accounting Policies and Use of Estimates

The preceding discussion and analysis of our results of operations and financial condition is based upon our ~~consolidated~~Consolidated ~~financial~~Financial ~~statements,~~Statements. ~~which~~Our Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”.), ~~The~~which ~~preparation~~require ofus ~~these~~to ~~consolidated~~make ~~financial~~estimates ~~statements~~and ~~requires~~assumptions usin tocertain ~~make~~circumstances ~~judgments~~that, ~~and~~giving ~~estimates~~due ~~that~~consideration to materiality, affect the reported amounts of assets, and liabilities, revenues and expenses and related disclosures as of the date of the financial statements. We ~~base~~regularly review our estimates and assumptions, which are based on historical experience and on various other factors that weare ~~believe~~believed ~~are~~to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results ~~could~~may differ from our estimates, and significant variances could materially impact our financial condition and results of operations under different assumptions or conditions.

~~Our~~We believe that of our significant accounting policies, ~~are~~the ~~more~~following ~~fully~~are ~~described~~particularly inimportant to the ~~notes~~portrayal toof our ~~consolidated~~results of operations and financial ~~statements~~position ~~included~~and inis ~~this~~subject ~~Annual~~to ~~Report~~an oninherent ~~Form~~degree ~~10-K. We~~of ~~believe~~uncertainty as it may require the ~~following~~application of a higher level of subjectivity and judgment by us. Our significant accounting policies toare befully ~~the~~described ~~most~~in ~~critical~~Note 2 to ~~understanding~~the ~~our~~Consolidated ~~results~~Financial ofStatements ~~operations~~included ~~and~~in ~~financial~~Item ~~condition~~8 ~~because~~of ~~they~~Part ~~require~~II ~~the~~of ~~most~~this ~~subjective~~Annual ~~and~~Report ~~complex~~on ~~judgments~~Form 10-K.

~~Revenue Recognition~~64

WeTable adopted the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Revenue from Contracts with Customers Topic 606 (“ASC 606”) effective January 1, 2018 using the modified retrospective transition method. The following is a summary, and the critical aspects, of ~~our revenue recognition policy under ASC 606.~~Contents

Revenue Recognition (Variable Consideration)

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services.

We enter into contracts with partners that often contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex, and we may receive various types of consideration over the life of the arrangement, including: up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties.

In assessing our revenue arrangements, ~~in accordance with ASC 606~~ we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price, such as the estimation of product returns and sales allowances in connection with the sale of our proprietary products.

Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. For example, we must estimate future product returns and sales allowances at the time of sales to distributors. The expected value is determined based on unit sales data, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel, contractual terms with customers and third-party payers, historical and expected utilization rates, and any new or anticipated changes in programs or regulations. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods.

~~Income~~ITEM ~~Taxes~~7A. QUANTITATIVE ~~and~~AND ~~Valuation~~QUALITATIVE ofDISCLOSURES ~~Deferred~~ABOUT ~~Tax~~MARKET ~~Assets~~RISK

~~The~~Foreign ~~Company~~Currency ~~accounts~~Exchange for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”). Significant judgment is required in determining income tax benefit or expense and in evaluating uncertainties under ASC 740. Deferred taxes are recorded for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Valuation allowances are established when it is determined that it is more likely than not that some portion or all of a deferred tax asset (“DTA”) will not be realized. The Company’s deferred tax assets are primarily the result of U.S. federal net operating loss carryforwards (“NOLs”) and tax credit carryforwards. Risk

~~During~~We ~~the~~are ~~year~~exposed ~~ended~~to ~~December~~foreign ~~31,~~exchange ~~2020,~~rate fluctuations of the ~~Company~~Swiss ~~released~~Franc to the ~~valuation~~U.S. ~~allowance~~dollar onas ~~its~~the ~~deferred~~financial ~~tax~~position ~~assets~~ and ~~recognized~~operating aresults ~~$46.3~~of ~~million~~our ~~income~~subsidiaries ~~tax~~in ~~benefit.~~Switzerland ~~Management~~are ~~determined~~translated ~~that,~~into asU.S. adollars ~~result~~for ofconsolidation. ~~generating~~Our ~~pretax~~exposure ~~earnings,~~to ~~utilization~~foreign ofexchange ~~net~~rate ~~operating~~fluctuations ~~loss~~also ~~carryovers~~arises ~~and~~from ~~projected~~transferring ~~pre-tax~~funds ~~earnings,~~to ~~there~~our isSwiss ~~sufficient~~subsidiaries ~~positive~~in ~~evidence~~Swiss toFrancs. In ~~conclude~~addition, ~~that~~we ithave isexposure ~~more~~to ~~likely~~exchange ~~than~~rate ~~not~~fluctuations ~~that~~between ~~its~~the Euro and the U.S. ~~deferred~~dollar ~~taxes~~for ~~are~~some ~~realizable.~~of ~~The~~our ~~realization~~transactions. ofWe ~~deferred~~do ~~tax~~not ~~assets~~currently isuse ~~dependent~~derivative ~~upon~~financial ~~the~~instruments ~~Company's~~to ~~ability~~hedge toagainst ~~generate~~exchange ~~sufficient~~rate ~~future~~risk. The ~~taxable~~effect ~~income~~of ~~during~~foreign ~~the~~exchange ~~periods~~rate influctuations ~~which~~on ~~those~~our ~~temporary~~financial ~~differences~~results ~~become~~for ~~deductible,~~the ~~prior~~year toended ~~the~~December ~~expiration~~31, of2021 ~~the~~was ~~tax~~not ~~attributes~~material. ~~The~~In ~~evaluation~~addition, ofa ~~deferred~~hypothetical ~~tax~~10% ~~assets~~appreciation ~~requires~~or ~~judgment~~depreciation in ~~assessing~~foreign currencies against the ~~likely~~U.S. ~~future~~dollar, ~~tax~~assuming ~~consequences~~all ofother ~~events~~variables ~~that~~are held constant, would not have ~~been~~a ~~recognized~~material inimpact ~~the~~on ~~Company's~~our financial ~~statements~~position or ~~tax~~operating ~~returns~~results ~~and~~for ~~forecasting~~the ~~future~~year ~~profitability~~ended December 31, 2021.

55Interest Rate Risk

~~Management~~We ~~assessed~~are ~~the~~directly ~~available~~exposed ~~positive~~to ~~and~~changes ~~negative~~in ~~evidence~~market tointerest ~~estimate~~rates ifon ~~sufficient~~our ~~future~~long-term ~~taxable~~debt ~~income~~as ~~will~~our secured floating rate credit facility requires interest payments to be ~~generated~~calculated at a floating rate tied in part to ~~utilize~~LIBOR ~~existing~~or, ~~deferred~~if ~~tax~~LIBOR ~~assets~~is no longer available, at a replacement rate as defined within the ~~applicable~~Credit ~~expiration~~Facility ~~period~~Agreement. ~~While~~As ~~management~~a ~~believes~~result, itchanges ~~has~~in ~~utilized~~the afloating ~~reasonable~~interest ~~method~~rate ~~for~~can ~~its~~affect ~~determination~~our ofoperating ~~DTAs~~results and ~~the~~liquidity. ~~related~~As ~~release~~ of ~~its~~December ~~valuation~~31, ~~allowance~~2021, ~~should~~we ~~factors~~had ~~and~~floating ~~conditions~~interest ~~differ~~rate ~~materially~~debt ~~from~~of ~~those~~$20.0 ~~used~~million byoutstanding ~~management,~~carrying a floating interest rate of approximately 2.60% (one-month LIBOR rate plus the ~~actual~~applicable ~~realization~~margin of ~~DTAs~~2.50%). ~~could~~A ~~differ~~hypothetical ~~materially~~increase ~~from~~of 1 percentage point in floating interest rate, assuming principal payments in accordance with the ~~reported~~Credit ~~amounts~~Facility Agreement and all other variables held constant, would result in $0. 2 million increase in future annual interest expense.

~~Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK~~65

WeTable ~~are exposed to foreign exchange rate fluctuations~~ of the Swiss Franc to the U.S. dollar as the financial position and operating results of our subsidiaries in Switzerland are translated into U.S. dollars for consolidation. Our exposure to foreign exchange rate fluctuations also arises from transferring funds to our Swiss subsidiaries in Swiss Francs. In addition, we have exposure to exchange rate fluctuations between the Euro and the U.S. dollar. We do not currently use derivative financial instruments to hedge against exchange rate risk. The effect of foreign exchange rate fluctuations on our financial results for the years ended December 31, 2020, 2019, and 2018 was not material.Contents

WeITEM are also exposed to interest rate risk and interest rate fluctuations as a result of our long-term debt financing. Our Term Loan, with a current outstanding principal of $40.0 million, accrues interest at a calculated prime-based variable rate with a maximum interest rate of 9.50%. The interest rate in effect as of December 31, 2020 was 8.~~5%.~~ FINANCIAL ASTATEMENTS ~~hypothetical~~AND ~~increase~~SUPPLEMENTARY ~~or decrease in the interest rate of 1.0% would result in additional or lower incremental annual interest expense of $400,000.~~DATA

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ANTARES PHARMA, INC.

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm	58
Report of Independent Registered Public Accounting Firm (KPMG LLP, Minneapolis, MN, Auditor Firm ID: 185)		67
Consolidated Balance Sheets as of December 31, 2020 and 2019	61
Consolidated Balance Sheets as of December 31, 2021 and 2020		69
Consolidated Statements of Operations for the Years Ended December 31, 2020, 2019 and 2018	62
Consolidated Statements of Operations for the Years Ended December 31, 2021, 2020 and 2019		70
Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2020, 2019 and 2018	63
Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2021, 2020 and 2019		71
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2020, 2019 and 2018	64
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021, 2020 and 2019		72
Consolidated Statements of Cash Flows for the Years Ended December 31, 2020, 2019 and 2018	65
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021, 2020 and 2019		73
Notes to Consolidated Financial Statements	66	74

5766

Table of Contents

Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of ~~DirectorsAntares~~Directors ~~Pharma, Inc.:~~

Antares Pharma, Inc.:

Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting

We have audited the accompanying consolidated balance sheets of Antares Pharma, Inc. and subsidiaries (the Company) as of December 31, ~~2020~~2021 and ~~2019~~2020, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, ~~2020~~2021, and the related notes (collectively, the consolidated financial statements). We also have audited the Company’s internal control over financial reporting as of December 31, ~~2020~~2021, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, ~~2020~~2021 and ~~2019~~2020, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, ~~2020~~2021, in conformity with U.S. generally accepted accounting principles. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, ~~2020~~2021 based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Change in Accounting Principles

As discussed in Note 2 to the consolidated financial statements, the Company has changed its method of accounting for leases as of January 1, 2019, due to the adoption of Financial Accounting Standards Board Accounting Standards Update (“ASU”) No. 2016-02 Leases (Topic 842), and related amendments.

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’'s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

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~~accordance~~Table ~~with authorizations~~ of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Contents

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Critical Audit ~~Matters~~Matter

The critical audit ~~matters~~matter communicated below ~~are~~is ~~matters~~a matter arising from the current period audit of the consolidated financial statements that ~~were~~was communicated or required to be communicated to the audit committee and that: (1) ~~relate~~relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit ~~matters~~matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit ~~matters~~matter below, providing a separate ~~opinions~~opinion on the critical audit ~~matters~~matter or on the accounts or disclosures to which ~~they~~it ~~relate~~relates.

~~Evaluation~~Government ~~of certain assumptions impacting the government~~ and insurance plan rebate reserves

As discussed in Note 2 to the consolidated financial statements, the Company records estimated reserves for rebates and chargebacks, which includes government and insurance plan rebate reserves. As of December 31, ~~2020~~2021, the reserve for rebates and chargebacks was $713,~~187~~301 thousand. The estimated reserves for government and insurance plan rebates are recorded as a reduction to product revenue in the same period that the related revenue is recognized and the reserves are included within current liabilities in the consolidated balance sheets. The government and insurance plan rebate reserves are estimated based on unit sales data, contractual terms with third-party payers, historical and estimated future percentages of rebates incurred on sales, historical and estimated future insurance plan billings, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates to be paid, and levels of inventory in the distribution channel.

We identified the evaluation of ~~the~~certain government and insurance plan rebate reserves as a critical audit matter. Subjective and challenging auditor judgment was required to evaluate the estimated future percentages of rebates incurred on sales for government plan rebates and the estimated future insurance plan billings for insurance plan rebates due to the unpredictability of those future amounts, and the length of time between when the sale occurred and when the rebates are paid to the administrator of the programs. ~~Payments are generally made in four to six months for government rebates and two to three months for insurance plan rebates.~~

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s government and insurance plan rebate reserves ~~process~~processes. This included controls ~~over~~related to management’s process to develop the estimated future percentages of rebates incurred on sales and the estimated future insurance plan billings. We tested the historical rebates incurred on sales and insurance plan billings, ~~that~~which ~~were~~are ~~utilized~~used asin ~~inputs~~the determination of estimated future percentages of rebates incurred on sales and insurance plan billings respectively, by comparing samples of the historical rebates incurred on sales and insurance plan billings to underlying invoices and evidence of the ~~estimated~~cash ~~reserves~~disbursement. WeFor both government and insurance plan rebate reserves, we assessed management’s estimate by evaluating the consistency of the inputs with the trend of actual historical percentages of rebates incurred on sales and insurance plan billings. For the insurance plan rebate reserve, we evaluated management’s estimate by comparing insurance plan billings received after period end to the ~~reserve~~estimated ~~estimate~~insurance plan billings recorded at year-end. For the government plan rebate reserve, we performed sensitivity analyses, ~~using~~over ~~historical information, on~~ the estimated future percentages of rebates incurred on sales ~~and~~using ~~compared~~historical information to assess the ~~results~~impact toof changes in those assumptions on management’s estimate. We evaluated the Company’s ability to estimate government and insurance plan rebate reserves accurately by comparing actual amounts ~~incurred~~paid for the related rebates to historical estimates.

Evaluation of the realizability of deferred tax assets

As discussed in Note 13 to the consolidated financial statements, the Company recorded a net valuation allowance release of $53,383 thousand on its deferred tax assets during the year ended December 31, 2020. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized based on an assessment of the available positive and negative evidence. The Company had gross deferred tax assets of $51,349 thousand, which includes U.S. net operating losses of $36,071 thousand as of December 31, 2020.

We identified the evaluation of the realizability of deferred tax assets as a critical audit matter due to the Company’s history of generating significant net operating losses. Subjective and challenging auditor judgment was required to assess the application of tax laws and evaluate the projected future taxable income over the periods in which those temporary differences become deductible.

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s evaluation of the realizability of deferred tax assets, including controls related to the application of tax laws and the projections of future taxable income. To evaluate the Company’s ability to project future taxable income, we compared the Company’s previous annual projections to actual results. We performed a sensitivity analysis over the amount and timing of forecasted taxable income to assess the impact on utilization of deferred tax assets. We involved income tax professionals with specialized skills and knowledge, who assisted in assessing the Company’s application of tax laws and evaluating the realizability of deferred tax assets.

/s/ KPMG LLP

We have served as the Company’s auditor since 1995.

Minneapolis, MNMinnesota

March 23, ~~2021~~2022

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ANTARES PHARMA, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

	December 31,			December 31,
		December 31, 2021					December 31, 2020
	2020			2019
Assets
Assets
Current assets
Current Assets:
Cash and cash equivalents		$	65,913				$	53,137
Cash and cash equivalents	$	53,137		$	23,201
Short-term investments		1,245					—
Short-term investments		—			22,520
Accounts receivable, net		56,697					42,221
Accounts receivable		42,221			35,074
Other receivables		26,311					—
Inventories		18,216			16,000
Inventories, net		11,544					18,216
Contract assets		8,~~140~~030			~~8,235~~		8,140
Prepaid expenses and other current assets		4,~~877~~532			~~3,416~~		4,877
Total current assets		~~126~~174,~~591~~272			~~108,446~~		126,591
Deferred tax assets, net		4633,~~982~~043			—		46,982
Property and equipment, net		2426,~~020~~015			~~15,961~~		24,020
Operating lease right-of-use assets		43,~~621~~774			~~5,463~~		4,621
Intangibles, net		717,~~693~~879			~~478~~		7,693
Goodwill		1,095			~~1,095~~		1,095
Other assets		1,529			1,308
Other long-term assets		1,427					1,529
Total Assets	$	212,531		$	132,751
Total assets		$	257,505				$	212,531
Liabilities and Stockholders’ Equity
Current Liabilities:
Current liabilities
Accounts payable	$	~~16,194~~$	17,056	$	~~12,905~~		$	16,194
Accrued expenses and other liabilities		2535,~~635~~043			~~16,523~~		25,635
Long-term debt, current portion		16,230			—
Current maturities of long-term debt, net		1,500					16,230
Operating lease liabilities, current portion		1,203			1,249
Operating lease liabilities, current		904					1,203
Deferred revenue		34,~~943~~427			~~1,738~~		3,943
Total current liabilities		6358,~~205~~930			~~32,415~~		63,205
Long-term debt		24,669			40,395
Long-term debt, less current maturities		18,241					24,669
Operating lease liabilities, long-term		4,~~816~~576			~~5,441~~		4,816
Other long-term liabilities		~~726~~—			—		726
Total liabilities		9381,~~416~~747			~~78,251~~		93,416
Commitments and contingencies (Note 16)
Stockholders’ Equity:
Stockholders’ Equity
Preferred Stock: $0.01 par, authorized 3,000 shares, none outstanding		—			—
Preferred Stock: $0.01 par; 3,000 shares authorized, none outstanding		—					—
Common Stock: $0.01 par; authorized 300,000 shares; 166,836 and 165,221 issued and outstanding at December 31, 2020 and 2019, respectively		1,668			1,652
Common Stock: $0.01 par; 300,000 shares authorized; 170,072 and 166,836 issued and outstanding as of December 31, 2021 and December 31, 2020, respectively		1,701					1,668
Additional paid-in capital		~~340~~351,~~756~~079			~~332,377~~		340,756
Accumulated deficit		(~~222~~176,~~626~~337)	)		~~(278,827~~	)	(222,626)
Accumulated other comprehensive loss		(~~683~~685)	)		~~(702~~	)	(683)
		119,115			54,500
Total stockholders’ equity		175,758					119,115
Total Liabilities and Stockholders’ Equity	$	212,531		$	132,751
Total liabilities and stockholders’ equity		$	257,505				$	212,531

~~See~~The accompanying ~~notes~~Notes to Consolidated Financial Statements are an integral part of these consolidated financial statements.

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

	~~Years Ended December 31,~~	Years Ended December 31,
	2020			2019				2018
		2021					2020				2019
Revenue:
Revenue
Product sales	$	113,834		$	92,103			$	47,870
Product sales, net		$	126,667				$	113,834			$	92,103
Licensing and development revenue		1419,~~466~~623			~~7,529~~		14,466		~~6,753~~		7,529
Royalties		2137,~~299~~692			~~24,232~~		21,299		~~8,931~~		24,232
Total revenue		149,599			123,864				63,554
Total revenue, net		183,982					149,599				123,864
Operating expenses:
Operating expenses
Cost of product sales		5354,~~960~~418			~~46,267~~		53,960		~~29,094~~		46,267
Cost of development revenue		913,~~140~~863			~~4,208~~		9,140		~~1,971~~		4,208
Research and development		1014,~~121~~502			~~10,624~~		10,121		~~12,328~~		10,624
Selling, general and administrative		6273,~~759~~857			~~61,773~~		62,759		~~36,762~~		61,773
Total operating expenses		~~135~~156,~~980~~640			~~122,872~~		135,980		~~80,155~~		122,872
Gain on sale of assets		—38,591			—		—		~~12,500~~		—
Operating income (loss)		13,619			992				(4,101	)
Operating income		65,933					13,619				992
Other income (expense):
Other income (expense)
Interest expense		(3,~~787~~611)	)		~~(3,549~~	)	(3,787)		~~(2,675~~	)	(3,549)
Other, net		89			530				261
Other income (expense), net		(51)					89				530
Total other expense, net		(3,~~698~~662)	)		~~(3,019~~	)	(3,698)		~~(2,414~~	)	(3,019)
Net income (loss) before income taxes		9,921			(2,027	)			(6,515	)
Income (loss) before income taxes		62,271					9,921				(2,027)
Income tax benefit		46,280			—				—
Income tax provision (benefit)		15,982					(46,280)				—
Net income (loss)	$	~~56,201~~$	46,289	$	~~(2,027~~	)	$	$56,201	~~(6,515~~	)	$	(2,027)
Net income (loss) per common share, basic	$	0.34		$	(0.01	)		$	(0.04	)
Earnings (loss) per common share
Net income (loss) per common share, diluted	$	0.33		$	(0.01	)		$	(0.04	)
Basic		$	0.27				$	0.34			$	(0.01)
Weighted average common shares outstanding
Diluted		$	0.26				$	0.33			$	(0.01)
Basic		166,066			162,574				157,407
Weighted average common shares outstanding
Diluted		170,155			162,574				157,407
Basic		169,226					166,066				162,574
Diluted		174,733					170,155				162,574

~~See~~The accompanying ~~notes~~Notes to ~~consolidated~~Consolidated ~~financial~~Financial ~~statements~~Statements are an integral part of these Consolidated Financial Statements.

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

	~~Years Ended December 31,~~	Years Ended December 31,
	2020			2019				2018
		2021					2020				2019
Net income (loss)	$	~~56,201~~$	46,289	$	~~(2,027~~	)	$	$56,201	~~(6,515~~	)	$	(2,027)
Foreign currency translation adjustment		19(2)			1		19		(3	)	1
Comprehensive income (loss)	$	~~56,220~~$	46,287	$	~~(2,026~~	)	$	$56,220	~~(6,518~~	)	$	(2,026)

~~See~~The accompanying ~~notes~~Notes to ~~consolidated~~Consolidated ~~financial~~Financial ~~statements~~Statements are an integral part of these Consolidated Financial Statements.

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Years Ended December 31, 2018, 2019 and 2020

(in thousands)

	~~Common Stock~~	Common Stock
	Number of Shares		Amount			Additional Paid-In Capital			Accumulated Deficit			Accumulated Other Comprehensive Loss				Total Stockholders’ Equity
		NumberofShares			Amount					AdditionalPaid-InCapital					AccumulatedDeficit				AccumulatedOtherComprehensiveIncome (Loss)		TotalStockholders’Equity
December 31, 2017		156,675	$	1,567		$	302,965		$	(270,285	)	$	(700	)		$	33,547
Balance, December 31, 2018		159,721			$	1,597				$	314,907				$	(276,800)			$	(703)	$	39,001
Issuance of common stock		2,~~137~~307		21	23		~~7,093~~			—7,758			—		—		~~7,114~~		—		7,781
Common stock issued under equity compensation plan, net of shares withheld for taxes		~~462~~664		5	7		~~(548~~	)		—(1,138)			—		—		~~(543~~	)	—		(1,131)
Exercise of options		~~447~~2,529		4	25		~~470~~			—4,380			—		—		~~474~~		—		4,405
Share-based compensation		—		—	—		~~4,927~~			—6,470			—		—		~~4,927~~		—		6,470
Net loss		—		—	—		—			~~(6,515~~—	)		—		(2,027)		~~(6,515~~	)	—		(2,027)
Other comprehensive loss		—		—			—			—			(3	)			(3	)
Other comprehensive income		—			—					—					—				1		1
December 31, 2018		159,721		1,597			314,907			(276,800	)		(703	)			39,001
Balance, December 31, 2019		165,221			1,652					332,377					(278,827)				(702)		54,500
Issuance of common stock		2,307		23			7,758			—			—				7,781
Common stock issued under equity compensation plan, net of shares withheld for taxes		676			7					(1,374)					—				—		(1,367)
Common stock issued under equity compensation plan, net of shares withheld for taxes		664		7			(1,138	)		—			—				(1,131	)
Exercise of options		939			9					1,805					—				—		1,814
Exercise of options		2,529		25			4,380			—			—				4,405
Share-based compensation		—			—					7,948					—				—		7,948
Share-based compensation		—		—			6,470			—			—				6,470
Net income		—			—					—					56,201				—		56,201
Net loss		—		—			—			(2,027	)		—				(2,027	)
Other comprehensive income		—			—					—					—				19		19
Other comprehensive loss		—		—			—			—			1				1
Balance, December 31, 2020		166,836			1,668					340,756					(222,626)				(683)		119,115
December 31, 2019		165,221		1,652			332,377			(278,827	)		(702	)			54,500
Common stock issued under equity compensation plan, net of shares withheld for taxes		942			10					(2,851)					—				—		(2,841)
Common stock issued under equity compensation plan, net of shares withheld for taxes		676		7			(1,374	)		—			—				(1,367	)
Exercise of options		2,294			23					5,159					—				—		5,182
Exercise of options		939		9			1,805			—			—				1,814
Share-based compensation		—			—					8,015					—				—		8,015
Share-based compensation		—		—			7,948			—			—				7,948
Net income		—			—					—					46,289				—		46,289
Net income		—		—			—			56,201			—				56,201
Other comprehensive loss		—			—					—					—				(2)		(2)
Other comprehensive income		—		—			—			—			19				19
Balance, December 31, 2021		170,072			$	1,701				$	351,079				$	(176,337)			$	(685)	$	175,758
December 31, 2020		166,836	$	1,668		$	340,756		$	(222,626	)	$	(683	)		$	119,115

~~See~~The accompanying ~~notes~~Notes to ~~consolidated~~Consolidated ~~financial~~Financial ~~statements~~Statements are an integral part of these Consolidated Financial Statements.

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ANTARES PHARMA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

	~~Years Ended December 31,~~	Years Ended December 31,
	2020			2019				2018
		2021					2020				2019
Cash flows from operating activities:
Cash Flows from Operating Activities
Net income (loss)	$	~~56,201~~$	46,289	$	~~(2,027~~	)	$	$56,201	~~(6,515~~	)	$	(2,027)
Adjustments to reconcile net income (loss) to cash provided by
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
(used in) operating activities:
Deferred taxes		13,939					(47,203)				(371)
Income tax benefit		(46,982	)		—				—
Stock-based compensation		8,015					7,948				6,470
Share-based compensation expense		7,948			6,470				4,927
Depreciation and amortization		3,901					2,627				2,557
Depreciation and amortization		2,627			2,557				2,724
Non-cash interest expense		648					504				405
Non-cash interest expense		504			405				268
Increase in inventory reserve		152					511				325
Increase in inventory reserve		511			325				592
Gain on sale of assets		(38,591)					—				—
Loss (gain) on sale or disposal of assets		22			—				(12,500	)
Other		671					42				12
Other		20			12				(7	)
Changes in operating assets and liabilities:
Changes in operating assets and liabilities:
Accounts receivable		(14,476)					(7,128)				(16,095)
Accounts receivable		(7,128	)		(16,095	)			(7,099	)
Inventories, net		2,748					(2,728)				(4,975)
Inventories		(2,728	)		(4,975	)			(2,667	)
Contract assets		110					53				(2,793)
Contract assets		53			(2,793	)			(4,937	)
Prepaid expenses and other current assets		(1,056)					(1,460)				(655)
Prepaid expenses and other current assets		(1,460	)		(655	)			(324	)
Accounts payable		2,189					2,594				926
Other assets		(221	)		(371	)			—
Accrued expenses and other liabilities		11,596					7,157				4,888
Accounts payable		2,594			926				5,164
Deferred revenue		484					2,202				718
Accrued expenses and other liabilities		7,157			4,888				5,029
Net cash provided by (used in) operating activities		36,619					21,320				(10,615)
Deferred revenue		2,202			718				(1,977	)
Cash Flows from Investing Activities
Net cash provided by (used in) operating activities		21,320			(10,615	)			(17,322	)
Purchases of property and equipment		(6,617)					(9,615)				(2,350)
Cash flows from investing activities:
Proceeds from sale of assets, net of transaction costs		17,825					282				5,000
Proceeds from maturities of investment securities		22,500			—				5,000
Purchase of intangibles, including transaction costs		(13,815)					(5,000)				—
Purchases of investment securities		—(1,245)			~~(22,645~~	)	—		—		(22,645)
Purchases of property and equipment		(9,615	)		(2,350	)			(854	)
Proceeds from maturities of investment securities		—					22,500				—
Proceeds from sale of assets		282			5,000				7,500
Net cash provided by (used in) investing activities		(3,852)					8,167				(19,995)
Purchase of intangibles		(5,000	)		—				(40	)
Cash Flows from Financing Activities
Net cash provided by (used in) investing activities		8,167			(19,995	)			11,606
Proceeds from issuance of long-term debt		20,000					—				15,000
Cash flows from financing activities:
Principal payments of long-term debt		(40,000)					—				—
Proceeds from issuance of long-term debt		—			15,000				—
Prepayment fees and end of term charge on long-term debt		(2,055)					—				—
Payment of debt issuance costs		—			(136	)			—
Payment of debt issuance costs for long-term debt		(276)					—				(136)
Proceeds from issuance of common stock, net		—			~~7,781~~		—		~~7,114~~		7,781
Proceeds from exercise of stock options		15,~~814~~182			~~4,405~~		1,814		~~474~~		4,405
Taxes paid related to net share settlement of equity awards		(12,~~367~~841)	)		~~(1,131~~	)	(1,367)		~~(543~~	)	(1,131)
Net cash provided by financing activities		447			25,919				7,045
Net cash provided by (used in) financing activities		(19,990)					447				25,919
Effect of exchange rate changes on cash		2			—				1
Effect of exchange rate changes on cash and cash equivalents		(1)					2				—
Net increase (decrease) in cash and cash equivalents		29,936			(4,691	)			1,330
Cash and cash equivalents
Cash and cash equivalents:
Net increase (decrease) during the period		12,776					29,936				(4,691)
Beginning of year		23,201			27,892				26,562
Beginning of period		53,137					23,201				27,892
End of year	$	53,137		$	23,201			$	27,892
End of period		$	65,913				$	53,137			$	23,201
Supplemental disclosure of cash flow information:
Supplemental disclosure of cash flow information
Cash paid for interest	$	~~3,538~~$	2,736	$	~~3,025~~		$	$3,538	~~2,353~~		$	3,025
Supplemental disclosure of non-cash investing activities:
Cash paid for income taxes		$	1,783				$	90			$	—
Purchase of intangible assets included in accrued liabilities	$	2,500		$	—			$	—
Supplemental disclosure of non-cash investing activities
Purchases of property and equipment included in accounts payable and accrued liabilities	$	2,017		$	970			$	49
Purchases of property and equipment recorded in accounts payable and accrued expenses		$	259				$	2,017			$	970
Gain on sales of assets recognized in excess of cash received	$	—		$	—			$	5,000
Purchase of intangible assets included in accrued liabilities		$	—				$	2,500			$	—
Gain on sale of assets recognized in excess of cash received		$	20,766				$	—			$	—

~~See~~The accompanying ~~notes~~Notes to ~~consolidated~~Consolidated ~~financial~~Financial ~~statements~~Statements are an integral part of these Consolidated Financial Statements.

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Table of Contents

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

Note 1. Description of Business

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies in targeted therapeutic areas. We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to provide commercial or functional advantages, such as improved safety and efficacy, ~~reduced~~convenience, ~~side~~improved ~~effects~~tolerability, and enhanced patient comfort and adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed ~~significant strategic alliances and~~ partnership arrangements with several different industry leading pharmaceutical companies ~~including Teva Pharmaceutical Industries, Ltd~~. ~~(“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”), Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals Ltd (“Idorsia”).~~

Our marketed proprietary products include:

• XYOSTED® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and is the first and only subcutaneous testosterone enanthate product for once-weekly, at-home self-administration to be approved by the U.S. Food and Drug Administration (“FDA”);

• OTREXUP® (methotrexate) injection, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis, which was sold to Otter Pharmaceuticals, LLC (a subsidiary of Assertio Holdings, Inc., together with Assertio Holdings, Inc., as guarantor, individually and collectively referred to as “Otter”) in December 2021 as discussed in Note 12; and

• NOCDURNA® (desmopressin acetate), marketed in the U.S. for the treatment of nocturia due to nocturnal polyuria (“NP”) in adults who awaken at least two times per night to urinate.

~~The~~We ~~Company~~are is also party to various partnered product development and supply arrangements:

• We developed and are the exclusive supplier of devices for Teva Pharmaceutical Industries, Ltd.’s (“Teva”) Epinephrine Injection USP products, the generic equivalent of EpiPen® and EpiPen® Jr., indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients;

• Through our commercialization partner Teva, we sell Sumatriptan Injection USP, a generic equivalent to the Imitrex® STATdose Pen®, ~~indicated~~ in the U.S. indicated for the acute treatment of migraine headaches and cluster headache in adults;

• In collaboration with AMAG Pharmaceuticals, Inc. (“AMAG”), acquired by Covis Group S.a.r.l. (“CG”) (collectively CG and AMAG are herein after referred to as “Covis”) in November 2020, we developed a subcutaneous auto injector and are the exclusive supplier of devices and the final assembled and packaged commercial product of ~~AMAG’s~~ Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered at least one preterm baby in the past.

• We developed and are the exclusive supplier of devices for Teva’s generic equivalent of Forsteo® (Teriparatide Injection) which is approved and currently sold by Teva in various countries outside the ~~United States~~U.S.

~~The~~Additionally, ~~Company~~we isare ~~also~~ developing ~~two~~other ~~multi-dose~~devices ~~pen injector products~~ in collaboration with ~~Teva,~~various apharmaceutical ~~combination~~partners ~~drug device rescue pen in collaboration with Pfizer, a combination drug device product with Idorsia,~~ and advancing other internal research and development programs.

2.We ~~Summary~~also have a proprietary product, TLANDO® (testosterone undecanoate) is a twice-day oral formulation of ~~Significant~~testosterone ~~Accounting~~for ~~Policies~~TRT indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males, with tentative FDA approval.

~~Basis of Presentation~~74

~~The~~Table ~~accompanying consolidated financial statements include the accounts~~ of ~~Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.~~Contents

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s most significant accounting estimates relate to revenue recognition and variable

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

~~consideration,~~Note ~~inventory~~2. Summary ~~valuation, the carrying value~~ of ~~deferred~~Significant ~~tax~~Accounting ~~assets and the valuation of equity instruments used in the computation of stock-based compensation. Actual results could differ from these estimates.~~Policies

Basis of Presentation

The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”) requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Our most significant accounting estimates relate to revenue recognition and variable consideration, inventory valuation, the carrying value of deferred tax assets and the valuation of equity instruments used in the computation of share-based compensation. Actual results could differ from these estimates, and significant variances could materially impact our financial condition and results of operations.

Reclassifications

Certain reclassifications have been made to prior year amounts to conform with the current year presentation. As of and for the year ended December 31, 2020, the cost of product sales and the cost of development revenue ~~are~~were ~~being~~ classified under the heading Operating expenses in the ~~accompanying~~Consolidated ~~consolidated~~Statements ~~statements~~ of ~~operations~~Operations, and the corresponding prior period ~~amounts~~amount ~~were~~was reclassified to conform to this presentation. The reclassifications had no impact on ~~the~~our ~~Company’s~~ operating income (loss), or net income (loss) or cash flows as previously reported.

Accounting Pronouncements Recently Adopted

~~The~~We ~~Company~~ adopted ~~Financial Accounting Standards Board (“~~FASB”) ~~Accounting Standards Update (“~~ASU”) No. ~~2016~~2018-~~02 Leases (“Topic 842”) and related amendments effective January 1~~15, Customers’ ~~2019,~~Accounting ~~electing~~for ~~the~~Implementation ~~package~~Costs ofIncurred ~~practical~~in ~~expedients~~Cloud ~~and~~Computing ~~applying~~Arrangement ~~the~~that ~~transition~~is ~~provisions~~a asService ~~of the~~ Contract, effective ~~date. Reporting periods beginning on or after~~ January 1, ~~2019 are presented under Topic 842~~2020, ~~while~~which ~~prior~~provides ~~period~~new ~~amounts,~~guidance ason ~~reported~~a ~~under~~customer’s ~~previous~~accounting ~~GAAP,~~for ~~were not adjusted. As of December 31~~implementation, ~~2018, the Company had non~~set-~~cancellable operating leases for its corporate headquarters in Ewing~~up, ~~New Jersey,~~ and ~~its~~other ~~administrative,~~upfront ~~research~~costs ~~and~~incurred ~~development facility~~ in ~~Plymouth, Minnesota,~~ a ~~suburb~~cloud ofcomputing ~~Minneapolis,~~arrangement ~~which~~that ~~were~~is ~~not~~hosted ~~previously~~by ~~required to be recorded on~~ the ~~balance~~vendor ~~sheet~~(i.e., As a ~~result~~service ofcontract). Under the ~~adoption~~new ofguidance, ~~Topic~~entities ~~842,~~apply the ~~Company~~same ~~recognized~~criteria ~~approximately~~for ~~$1.0~~capitalizing ~~million~~implementation incosts ~~right-of-use~~as ~~assets~~they ~~and~~would ~~lease~~for ~~liabilities~~an inarrangement ~~connection~~that ~~with~~has ~~its~~a ~~existing~~software ~~operating leases~~license. ~~The~~Adoption ~~adoption~~ of ~~Topic~~this ~~842~~standard ~~on January 1, 2019~~ did not have a ~~significant~~material impact on ~~the~~our ~~Company’s~~financial ~~consolidated~~condition, results of operations or ~~cash flows~~disclosures.

~~The~~We ~~Company~~ adopted ~~Financial Accounting Standards Board (“~~FASB”) ~~Accounting Standards Update (“~~ASU”) No. 2018-1518, Clarifying ~~Customers’~~the ~~Accounting~~Interaction ~~for~~Between ~~Implementation~~Topic ~~Costs~~808 ~~Incurred~~and ~~in Cloud Computing Arrangement that is a Service Contract~~606, effective January 1, 2020., ~~This~~which ~~ASU~~clarifies ~~provides~~that ~~new~~certain ~~guidance~~transactions onbetween acollaborative ~~customer's~~arrangement ~~accounting~~participants ~~for~~should ~~implementation,~~be ~~set-up,~~accounted ~~and~~for ~~other~~under ~~upfront~~the ~~costs~~revenue ~~incurred~~guidance, inadds aunit ~~cloud~~of ~~computing~~account ~~arrangement~~guidance ~~that~~to ~~is hosted by~~ the ~~vendor~~collaborative ~~(i.e.,~~arrangement aguidance ~~service~~to ~~contract).~~align ~~Under~~with the ~~new~~revenue ~~guidance~~standard, ~~entities~~and ~~apply~~clarifies ~~the~~presentation ~~same~~guidance ~~criteria~~ for ~~capitalizing~~transactions ~~implementation~~with ~~costs~~a ascollaborative ~~they~~arrangement ~~would~~participant ~~for~~that anis ~~arrangement~~not ~~that~~accounted ~~has~~for aunder ~~software~~the ~~license~~revenue standard. ~~The~~Adoption ~~Company’s adoption~~ of this standard did not have a material impact on ~~its~~our ~~consolidated~~ financial ~~statements~~condition, results of operations or disclosures.

~~The~~Recently ~~Company~~Issued ~~adopted~~Accounting ~~ASU~~Pronouncements ~~No.~~Not ~~2018-18~~Yet ~~Clarifying~~Adopted ~~the~~as ~~Interaction Between Topic 808 and 606~~December 31, ~~effective~~2021 January 1, 2020. The guidance clarifies that certain transactions between collaborative arrangement participants should be accounted for under the revenue guidance, adds unit of account guidance to the collaborative arrangement guidance to align with the revenue standard, and clarifies presentation guidance for transactions with a collaborative arrangement participant that is not accounted for under the revenue standard. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

~~Recent~~In ~~Accounting~~June ~~Pronouncements~~2016, ~~Not~~the ~~Yet~~FASB ~~Adopted~~issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, followed by related amendments, which changes the accounting for credit losses on instruments measured at amortized cost by adding an impairment model that is based on expected losses rather than incurred losses. Any entity will recognize as an allowance its estimate of expected credit losses, which is believed to result in more timely recognition of such losses as the standard eliminates the probable initial recognition threshold. The new guidance is required to be adopted using a modified retrospective approach with a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period of adoption. Adoption of the new guidance was originally required for annual periods beginning after December 3115, ~~2020~~2019, including interim periods within the annual period.

In 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables, and requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The original effective date for ASU 2016-13 was for annual and interim periods beginning after December 15, 2019. 75

~~However,~~Table ~~in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective Dates, which deferred the effective date~~ of ASU 2016-13 for certain entities, including those that are eligible to be smaller reporting companies. A company’s determination about whether it is eligible for the deferral is a one-time assessment as of November 15, 2019 based on its most recent determination of its small reporting company eligibility as of the last business day of the most recently completed second quarter. Based on this determination, the Company qualifies as a smaller reporting entity and is therefore eligible for the deferral of adoption of ASU 2016-13, resulting in a new effective date of January 1, 2023. The Company has historically had minimal credit losses on financial instruments and is currently evaluating the impact the adoption of ASU 2016-13 will have on its consolidated financial statements. Contents

ANTARES PHARMA, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts)

In October 2019, the FASB issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which deferred the effective date of ASU 2016-13 for certain entities, including those that are eligible for smaller reporting company classification. Determination of eligibility for deferral was a one-time assessment as of November 15, 2019 based on the entity’s most recent smaller reporting company eligibility determination as of the last business day of its most recently completed second quarter. Based on this determination, we qualified as a smaller reporting entity and was therefore eligible for the adoption deferral resulting in a new effective date of January 1, 2023. The impact on our financial condition, results of operations and disclosures is being evaluated but is not expected to be significant as we have historically had minimal credit losses on financial instruments.

In April 2020, the FASB issued ASU No. 2020-04, Facilitation of the Effects of Reference Rate Reform on Financial Reporting, which provides relief for companies preparing for discontinuation of interest rates such as LIBOR. The standard can be applied immediately through December 31, 2022. We have not yet evaluated the impact the adoption of this guidance may have on our financial condition, results of operations or disclosures.

Foreign Currency Translation

The majority of ~~the~~our foreign subsidiaries’ revenues are denominated in U.S. dollars, and any required funding of the subsidiaries is provided by the U.S. parent. Nearly all operating expenses of ~~the~~our foreign subsidiaries are denominated in Swiss Francs. Additionally, bank accounts held by foreign subsidiaries are denominated in Swiss Francs, there is a low volume of intercompany transactions and there is not an extensive interrelationship between the operations of the subsidiaries and the parent company. As such, ~~the~~we ~~Company~~have ~~has~~ determined that the Swiss Franc is the functional currency for ~~its~~our foreign subsidiaries. ~~The~~Our reporting currency ~~for the Company~~ is the United States Dollar (“USD”). The financial statements of ~~the~~our ~~Company’s~~ foreign subsidiaries are translated into USD for consolidation purposes. All assets and liabilities are translated using period-end exchange rates. ~~and~~Statements ~~statements~~ of operations items are translated using average exchange rates for the period. The resulting translation adjustments are recorded as a separate component of stockholders’ equity, comprising all of the accumulated other comprehensive income (loss). Sales to certain customers and purchases from certain vendors by the U.S. parent are in currencies other than ~~the~~ USD and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in other income (expense) in the ~~consolidated~~Consolidated ~~statements~~Statements of ~~operations~~Operations.

Cash and Cash Equivalents

Cash and cash equivalents ~~consist~~represent of demand deposits at commercial banks and highly liquid investments inwith ~~money~~an ~~market~~original ~~funds~~maturity ~~with maturities~~ of three months or less. Cash equivalents, consisting of investments in money market funds and bank certificate of deposits, are remeasured and re

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