As filed with the Securities and Exchange Commission on February 24, 2026.

Registration No. 333-292284

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 2

FORM S-1

REGISTRATION STATEMENT

UNDER THE

SECURITIES ACT OF 1933

MiniMed Group, Inc.

(Exact name of registrant as specified in its charter)


Delaware	3841	33-3985981
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)

18000 Devonshire St.

Northridge, CA 91325

(763) 514-4000

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Courtney Nelson Wills

MiniMed Group, Inc.

18000 Devonshire St.

Northridge, CA 91325

(763) 514-4000

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:


Adam E. Fleisher Kimberly R. Spoerri Synne D. Chapman Cleary Gottlieb Steen & Hamilton LLP One Liberty Plaza New York, NY 10006 (212) 225-2000			John B. Meade Yasin Keshvargar Arisa A. Sin Davis Polk & Wardwell LLP 450 Lexington Avenue New York, NY 10017 (212) 450-4000

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 ☐

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 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion, dated February 24, 2026

Preliminary Prospectus

28,000,000 Shares

MiniMed Group, Inc.

Common Stock

This is an initial public offering of shares of the common stock of MiniMed Group, Inc. We are offering 28,000,000 shares of our common stock.

Prior to this offering, there has been no public market for shares of our common stock. We estimate that the initial public offering price per share of our common stock will be between $25.00 and $28.00. We intend to list our shares of common stock on the Nasdaq Global Select Market (“Nasdaq”) under the symbol “MMED.”

Investing in shares of our common stock involves risks. See “Risk Factors” beginning on page 45 to read about factors you should consider before purchasing shares of our common stock.

Neither the Securities and Exchange Commission nor any state securities commission or other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.


	Per Share	Total
Initial public offering price	$	$
Underwriting discounts and commissions(1)	$	$
Proceeds to us, before expenses	$	$

__________________

(1)See “Underwriting” for a description of compensation to be paid to the underwriters.

We have granted the underwriters an option for a period of 30 days from the date of this prospectus to purchase up to an additional 4,200,000 shares of our common stock from us at the initial public offering price less the underwriting discounts and commissions to cover over-allotments.

The underwriters expect to deliver the shares of common stock against payment in New York, New York on or about , 2026.


Goldman Sachs & Co. LLC			BofA Securities			Citigroup			Morgan Stanley


Barclays	Deutsche Bank Securities	Mizuho	Wells Fargo Securities
Evercore ISI		Piper Sandler
BTIG		William Blair

Prospectus dated , 2026

TABLE OF CONTENTS


			Page
ABOUT THIS PROSPECTUS			iii
LETTER FROM THE C HIEF E XECUT IVE O FFICER			v
PROSPECTUS SUMMARY			1
THE OFFERING			31
SUMMARY HISTORICAL AND UNAUDITED PRO FORMA COMBINED FINANCIAL DATA			34
MARKET AND INDUSTRY DATA			40
RISK FACTORS			45
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS			91
USE OF PROCEEDS			94
DIVIDEND POLICY			95
CAPITALIZATION			96
DILUTION			97
THE SEPARATION AND DIVESTMENT TRANSACTIONS			99
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS			101
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			110
BUSINESS			136
MANAGEMENT			189
EXECUTIVE AND DIRECTOR COMPENSATION			199
PRINCIPAL STOCKHOLDER			238
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS			240
DESCRIPTION OF CAPITAL STOCK			254
DESCRIPTION OF CERTAIN INDEBTEDNESS			260
SHARES ELIGIBLE FOR FUTURE SALE			261
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR NON-U.S. HOLDERS OF OUR COMMON STOCK			263
UNDERWRITING			267
LEGAL MATTERS			277
EXPERTS			278
WHERE YOU CAN FIND MORE INFORMATION			279
INDEX TO FINANCIAL STATEMENTS			F-1

Through and including the 25th day after the date of this prospectus, all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This delivery is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

Neither we nor any of the underwriters have authorized anyone to provide any information or to make any representations other than those contained in this prospectus, any amendment or supplement to this prospectus, or any free writing prospectus prepared by us or on our behalf. We and the underwriters take no responsibility for, and cannot assure you as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares of our common stock offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so.

The information contained in this prospectus is current only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of shares of our common stock. Our business, results of operations, or financial condition may have changed since that date.

Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of our common stock and the distribution of this prospectus outside the United States.

ABOUT THIS PROSPECTUS

In connection with this offering, we (as defined below) will enter into a series of transactions with Medtronic pursuant to which Medtronic will transfer the assets and liabilities of the Diabetes Operating Unit (as defined below) to us. As consideration for these assets, we will assume the liabilities associated with the assets of the Diabetes Operating Unit and will issue to Medtronic shares of our common stock. We refer to these transactions, as further described in the section of this prospectus entitled “The Separation and Divestment Transactions—The Separation,” collectively as the “Separation.” As part of the Separation, we intend to (i) retain an amount of the net proceeds from this offering such that we will have approximately $350 million of cash on hand, which we will use for general corporate purposes, (ii) use the excess of the net proceeds from this offering over such retained amount to repay (or cause one or more of our subsidiaries to repay) intercompany debt owed to Medtronic under a note, and (iii) to the extent the net proceeds from this offering exceed the retained amount and the principal amount of such note, pay additional consideration to an affiliate of Medtronic for certain assets transferred to us in the Separation. For more information on the intercompany debt owed to Medtronic, see “Certain Relationships and Related Person Transactions—Other Agreements with Medtronic—Intercompany Debt.”

Unless otherwise indicated or the context otherwise requires, (1) references in this prospectus to the “Company,” the “Registrant,” “we,” “us,” and “our” refer to MiniMed Group, Inc., a Delaware corporation, and its consolidated subsidiaries assuming the completion of the Separation and (2) references in this prospectus to the “Diabetes Operating Unit” refer to the business that will be transferred to the Company in connection with the Separation, primarily representing the diabetes business segment of Medtronic. References in this prospectus to “Medtronic” or “Parent” refer to Medtronic plc, an Irish public limited company, and its consolidated subsidiaries other than MiniMed Group, Inc. and MiniMed Group, Inc.’s consolidated subsidiaries.

In addition, unless the context otherwise requires, statements relating to our history in this prospectus describe the history of the Diabetes Operating Unit of Medtronic and forward-looking statements assume the completion of all the transactions described in this prospectus, including the Separation.

Trademarks, Tradenames, and Service Marks

The trademarks, tradenames, and service marks of the Company appearing in this prospectus are, as applicable, our property, licensed to us, or, prior to the completion of this offering, the property of Medtronic. The name and mark, Medtronic, and other trademarks, tradenames, and service marks of Medtronic appearing in this prospectus are the property of Medtronic. Solely for convenience, trademarks, tradenames, and service marks referred to in this prospectus may appear without the “®,” “™,” or “℠” symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to these trademarks, tradenames, and service marks. This prospectus also contains additional trademarks, tradenames, and service marks belonging to other parties. We do not intend our use or display of these other parties’ trademarks, tradenames, or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, such other parties.

Basis of Presentation

We have historically operated as part of Medtronic. The financial information included in this prospectus has been prepared from Medtronic’s historical accounting records and is derived from the consolidated financial statements of Medtronic to present the Diabetes Operating Unit as if it had been operating on a standalone basis. The historical combined financial statements (together with the notes thereto, the “combined financial statements”) reflect our financial condition, results of operations, and cash flows as we were historically managed, in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The combined financial statements reflect all revenues, costs, assets, and liabilities that are either legally attributable to or directly associated with our business activities. The combined financial statements also reflect the net effect of transactions with Medtronic, including allocations of certain expenses for services from Medtronic that may have been historically allocated to the Diabetes Operating Unit, including, but not limited to, corporate and shared expenses related to finance and accounting, legal, information technology, human resources, facilities, marketing, insurance, employee benefits and incentives, restructuring and associated costs, and stock-based compensation. The allocations may not

iii

reflect the expenses the Diabetes Operating Unit would have incurred if it had been a standalone company for the periods presented. All such amounts have been deemed to have been incurred and settled by the Diabetes Operating Unit in the period in which the costs were recorded. All of these expenses have been allocated on a basis considered reasonable by management, using either specific identification when identifiable, or proportional allocations determined on the basis of revenue, usage, headcount, or other measures.

The financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during the periods presented, including changes that will occur in our operations and capital structure as a result of this offering and the Separation. In addition, the financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future. See “Risk Factors—Risks Related to the Separation and the Divestment—We have a limited history of operating as a standalone public company, and our historical and pro forma financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.”

We utilize a 52/53 week fiscal year, ending the last Friday in April, for the presentation of our financial statements and related notes thereto at April 25, 2025 and April 26, 2024 and for each of the fiscal years ended April 25, 2025 (fiscal year 2025), April 26, 2024 (fiscal year 2024), and April 28, 2023 (fiscal year 2023).

Non-GAAP Financial Measures

This prospectus contains certain financial measures, including Organic Revenue Growth, Adjusted Gross Profit, and Adjusted EBITDA, that are not required by, or prepared in accordance with, U.S. GAAP. We refer to these measures as “non-GAAP” financial measures. These are supplemental financial measures and should not be viewed as a substitute for GAAP financial measures. Although our management uses these non-GAAP financial measures when planning, monitoring, and evaluating our performance, any analysis of non-GAAP financial measures should be used only in conjunction with results presented in accordance with GAAP. The non-GAAP financial measures we present may not be comparable to similarly named measures reported by other companies.

See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Measures” for our definitions of these non-GAAP measures, information about how and why we use these non-GAAP measures, and a reconciliation of each of these non-GAAP measures to its most directly comparable financial measure calculated in accordance with U.S. GAAP.

Letter from the Chief Executive Officer

To our future shareholders,

MiniMed was founded in 1983 by Alfred E. Mann with one bold idea: that technology could do the work of a pancreas. His vision was to make diabetes care wearable, consumer-focused, and life-changing — automating the hardest parts of managing the disease so people could reclaim parts of their life that diabetes so often takes away. That belief sparked a revolution and guided the team to deliver many industry firsts, including the first pager-sized portable pump, the first continuous glucose monitor (CGM) used by physicians and the first wearable insulin pump integrated with a CGM automated by the first hybrid closed loop algorithm. Indeed, Mann’s vision and principles have guided every chapter of our story and it is the standard we measure ourselves against today.

For nearly 25 years, MiniMed has operated as part of Medtronic, a global leader in healthcare technology. Our business has evolved from a standalone insulin pump innovator into Medtronic’s global Diabetes business, delivering a full ecosystem of automated insulin pumps, CGMs, and smart insulin pens that generated roughly $2.7 billion in annual revenue in FY25 with recent double-digit growth. We are proud and grateful for our Medtronic chapter. It allowed us to build deep expertise, scale globally, and improve the lives of millions of people across more than 80 countries.

Today, I’d like to introduce the new MiniMed. We’re starting a new chapter that’s grounded firmly in the company’s original mission and trusted 40-year legacy that’s been built over long-standing partnerships with leading clinicians and the many diabetes communities around the world. Our goal is to accelerate the impact we can have as an independent company focused exclusively on helping insulin-dependent people with diabetes experience more predictable control, greater freedom, and better days while achieving strong outcomes.

MiniMed is a full-stack diabetes therapy company that includes integrated CGM, insulin delivery, and dosing algorithms unified in a single experience. The magic is the algorithm and how it brings automation together, delivering best-in-class outcomes with less work for users, and positioning us to lead the hands-free AID era.

Our North Star is to make every day a better day for people with diabetes. This will continue to guide all that we do.

The Invisible Work Diabetes Demands

If you don’t live with diabetes, it’s hard to understand the invisible tax it levies on people.

Having Type 1 or insulin-intensive Type 2 diabetes is not just a physical condition; it carries an enormous mental load. It requires a person to make upwards of 180 additional decisions each day, from counting carbs, to adjusting for exercise, stress and illness.

Despite this physical, mental, financial and emotional burden, people are often forced to settle for outcomes that fall short of what they want or deserve. Even highly engaged, diligent self-management cannot fully eliminate the long-term physical risk associated with chronic glucose variability, including complications affecting vision, kidney function, nerve health, and cardiovascular health. Burnout and fatigue are common; when they lead to lapses, even small ones, the consequences can be both immediate and lasting.

Persistent high glucose levels and hyperglycemia drive serious long-term complications and raise the risk of life-threatening events such as diabetic ketoacidosis, particularly for children who face a meaningful reduction in life expectancy when diabetes is not well controlled. Even when people achieve guideline-level control, with A1C below 7% and higher Time in Range, they still face higher risks of complications and more than double the risk of death compared to people without Type 1 diabetes.

This burden also extends to families, clinicians, and the health systems that support them. Everyone spends time coordinating devices, data, and decisions. Even with tremendous effort, today’s technology still asks too much. It should not be this way, and people with diabetes deserve the best outcomes with the least burden. We are helping to change lives by moving care toward simpler, more automated, and more “hands-free” experiences.

Ultimately, this is what drove me to join MiniMed in 2022 – the chance to revitalize our business and refocus for the decade ahead when there is such a monumental opportunity to improve the lives of our customers and lead the industry in a way that is beneficial for all our stakeholders.

Throughout my career, I’ve been drawn to complex, tech-enabled businesses where data, software, and connected devices can fundamentally improve people’s lives, from early strategy roles to leading Honeywell’s industrial software transformation. Those experiences taught me how to accelerate growth by focusing on developing innovation pipelines that reach customers, and lead large, global teams through change while staying grounded in a clear purpose. MiniMed offered the chance to bring that toolkit to a mission that is deeply personal for so many families, and to help accelerate the next generation of automated insulin delivery, unifying sensors, and algorithmic control into a simpler experience that reduces the daily burden while raising the bar on outcomes.

AID Technology is the Turning Point

Automated Insulin Delivery (AID) has become one of the most important advances in diabetes care, and clinical guidelines increasingly describe AID as the preferred standard of care for people who rely on intensive insulin therapy. The evidence is clear; AID helps people improve their time in range, with fewer highs and lows, and with far less day-to-day effort. Yet despite strong clinical results, most people who could benefit from AID are not using it today because systems have historically been complex, onboarding has required too many steps, and technology hasn’t always worked smoothly together.

The opportunity ahead is to make AID accessible, intuitive, and easy to live with. That is when adoption will truly accelerate.

To understand why AID matters, think of the difference between checking your speedometer and driving a car that adjusts automatically. Continuous Glucose Monitoring (CGM) is like a speedometer. It tells you the “speed” (glucose levels), but you still have to drive. MiniMed’s AID is like a self-driving car. It measures where you are, responds to where you’re headed, and automatically adjusts and corrects so you can stay safely on course, while easing the mental load of managing diabetes. This is the future we are building.

MiniMed is the only company today that commercializes all three essential components of an AID system — the algorithm, the insulin delivery (pump or pen), and the CGM — on one integrated software platform with a single, unified app. When these pieces work seamlessly together, they reduce the daily burden of diabetes and help people improve their time in range with less effort.

Better Days Look Different for Everyone

We know people manage their diabetes in different ways. Some want a durable pump. Some want a patch pump. Some prefer a smart pen. Some want everything on their phone. There is no single right way to manage diabetes or a single definition of a better day.

Our strategy is built around this truth. Better days takes many forms. Our ecosystem is built for choice, so every person can find the device that fits their life, all within a unified experience that makes starts simpler and day-to-day control closer than ever to truly hands-free. Behind every MiniMed system is a global network of engineers, clinicians, and people with diabetes, united by one idea: Better days should be within reach for everyone.

A Growing Need and a Clear Opportunity

More than 37 million people worldwide require intensive insulin therapy. The need is large, growing, and deeply underserved. In total, we estimate the current market for our diabetes technologies and other offerings to be approximately $18 billion. This market is expected to grow in double digits annually. Better technology can make a meaningful difference in outcomes, in quality of life, and in long-term health.

Our product portfolio, data foundation, and global footprint position us well to meet this growing need. We frame the opportunity through the lens of Automated Insulin Delivery; when automation, sensor choice, and a single app work together, adoption broadens and value compounds. As an independent company, we will be uniquely

focused on capturing this growth and more aligned with what consumers, clinicians, and health systems are asking for.

Why Independence Matters

Becoming independent gives us room to move at the pace this moment requires. It sharpens our focus. It clarifies our mission. It allows us to invest in the areas that matter most: CGM innovation, automation, user experience, and global access.

Independence also tightens accountability. We will measure ourselves against clear product milestones, operations KPIs, and real-world evidence. Our financial profile, margin opportunities, and long-term growth plan will also be clearer as a standalone company. It provides capital flexibility to fund growth and the shift toward recurring revenue, a large and growing addressable market, and an opportunity to expand access globally. They give us confidence in the path ahead.

Above all, independence helps us serve patients better. More focus leads to more innovation. And more innovation means more predictable control and better days for the people who count on us.

Looking Ahead

As we become a standalone company, we are rebuilding MiniMed with the discipline of a public company and the relentless drive of a startup. We continue to design our products and brand with the same care that people bring to managing their health. And we are committed to measuring our success not only by devices sold, but by the reduction of the daily burden and the improvements in Time in Range (TIR) for our patients.

To the investors joining us: MiniMed has a 40+ year head start since its founding in 1983 by Alfred E. Mann, with a digital technology platform built around real human needs and a dataset comprised of over 430 million datapoints of human glucose and insulin interactions. We are entering the AID era with an integrated, full-stack platform and the scale to deliver a simpler, near hands-free experience. Independence gives us the focus, accountability, and capital flexibility to execute. We are MiniMed. We unlock freedom by making better days an everyday reality for people living with diabetes. Join the company committed to building that future for millions.

Sincerely,

Que Dallara

Chief Executive Officer of MiniMed

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PROSPECTUS SUMMARY

This summary highlights selected information included elsewhere in this prospectus. To better understand the Separation and our business and financial condition, you should carefully review this entire prospectus. You should carefully consider, among other things, the sections entitled “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes included elsewhere in this prospectus. Unless the context otherwise requires, all references in this prospectus to the “Company,” the “Registrant,” “we,” “us,” and “our” refer to MiniMed Group, Inc.

Overview

We are a scaled global medical technology company that develops, manufactures, and markets a comprehensive suite of solutions for the management of diabetes. Since our founding more than 40 years ago, we have pioneered groundbreaking innovation and served the needs of our customers across the globe in service of our mission to make every day a better day for people with diabetes.

Today, we are the only player in the market that commercializes all parts of an integrated diabetes management system. This allows us to provide a five-star customer experience: an easier and consistent user experience, seamless integration, privacy and security, optimized performance and reliability, and our pioneering and industry-leading dosing algorithm, based on time in range (“TIR”) outcomes in real-world data. This differentiated value proposition is designed to solve two key problems for people with diabetes (“PWD”). First, we believe our products deliver superior health outcomes, when measured against European Association for the Study of Diabetes (“EASD”) and American Diabetes Association (the “ADA”) guidelines, by effectively and measurably improving glycemic control compared to other available treatment options and competing products. By enhancing glycemic control, our products can help reduce long-term complications of diabetes, improve longevity and quality of life, and reduce associated costs to health systems. Second, our customer experience reduces or substantially eliminates the burden of diabetes management for users, their families, their caregivers, and their healthcare providers (“HCPs”).

Diabetes is a chronic, life-threatening disease that affects the body’s production of and response to insulin, a hormone produced by the pancreas that is critical to the metabolism of glucose. It is a global epidemic, with 589 million PWD globally, according to the 2025 International Diabetes Foundation (“IDF”) World Atlas. The disease has no known cure and brings with it significant short and long-term health impacts, including risk of serious comorbidities. Managing diabetes is a 24/7 challenge that greatly impacts the overall quality of life of the person with diabetes as well as his or her family. People with Type 1 Diabetes (“T1D”) as well as those with Type 2 (“T2D”) who require background (basal) and mealtime (bolus) insulin must self-administer insulin multiple times per day and continuously monitor their blood glucose levels to inform their insulin dosing.

We serve PWD who require intensive insulin therapy, which represents all people with T1D and a subset of those with T2D. We address this market by offering various diabetes technologies, including insulin delivery devices (primarily insulin pumps and pens), continuous glucose monitors (“CGMs” or “CGM sensors”), other consumables, supplies, and related software and services. In total, we estimate the current market for our diabetes technologies and other offerings to be over $18 billion, based on last twelve months ended September 2025 revenue from public filings of leading diabetes device manufacturers as identified by Seagrove Partners. As of the time of this offering, we utilize a dual-channel approach in the United States where we distribute the majority of our products through the durable medical equipment (“DME”) channel and only a small percentage of our products through the pharmacy channel, whereas our market estimate includes companies that have broad coverage in the pharmacy channel. Our market is expected to grow at a compound annual growth rate above 10% from 2025 through at least 2030, according to Seagrove Partners’ November 2025 market model, driven by the adoption of advanced diabetes management technologies, like ours, which are currently underpenetrated in the market. The primary medical specialists who use and/or prescribe our products are endocrinologists, diabetologists, nurse practitioners, physician assistants, and primary care physicians (“PCPs”).

Our platform of simple and clinically effective solutions for PWD requiring insulin therapy includes:

•Automated Insulin Delivery (“AID”) Systems: Integrated solutions for glucose sensing and automated insulin dosing and administration, delivering superior glycemic control. Our system is composed of an

insulin pump that administers insulin, consumable insulin infusion sets and reservoirs, a CGM sensor that measures blood glucose levels, and a Smart Dosing algorithm that is designed to mimic how a healthy pancreas works. In our AID system, real-time CGM readings inform our Smart Dosing algorithm, which provides automatic adjustments and corrections to insulin pump dosing every five minutes based on target blood glucose settings and Meal Detection technology. This algorithm automatically informs insulin administration and wraparound applications, software, and services for users, caregivers, and HCPs, allowing users and caregivers to track and control their treatment through compatible smartphone applications. Our AID systems include our second-generation MiniMed 780G system, as well as our older MiniMed 770G, MiniMed 740G, MiniMed 720G, and MiniMed 630G systems.

•Smart Multiple Daily Injection (“MDI”) System: For those who prefer to self-administer insulin by manual injections or seek freedom from on-body devices, Smart MDI systems offer an integrated solution for sensing, dosing, and administration. Our Smart MDI system includes InPen (our Smart Insulin Pen for insulin administration), Simplera or Guardian 4 (our CGM), and wraparound applications and services. Our Bluetooth-enabled smart insulin pens connect with our Smart Dosing software and intuitive mobile app, which can track and personalize insulin dosing suggestions based on CGM sensor readings, including suggestions for mealtime and correction doses.

Today, we are the only company that commercializes all the constituent parts of these advanced solutions for diabetes therapy. We believe that other players in our market specialize in CGM sensors or insulin pumps and dosing algorithms, and therefore need to establish strategic partnerships and share data in order to offer Smart Dosing solutions. We believe that our presence in all parts of the Smart Dosing ecosystem is a significant advantage over our competitors because it can result in a more effective user experience, relieving some of the burdens of existing diabetes technology. Additionally, our data advantage in having both CGM and insulin data allows us to be more effective in developing high-quality products that drive better clinical outcomes, especially in the iterative, data-rich development of insulin dosing algorithms.

Our products deliver differentiated clinical efficacy and customer satisfaction. We believe our solutions have demonstrated superiority over the current standard of care of administering insulin through MDI manually with only a standalone unconnected blood glucose monitor (“BGM”) or CGM to inform dosing. An analysis of real-world evidence from a global dataset of approximately 400,000 users demonstrated that 80% of MiniMed 780G users using recommended optimal settings (“ROS users”) (16% of all users were ROS users), and 61% of all MiniMed 780G users, achieved >70% TIR. TIR is a representation of blood glucose levels as measured by a CGM device, expressed as a percentage of time spent between 70 and 180 mg/dL, or 3.9 and 10.0 mmol/L. The target for TIR, based on ADA guidelines, is >70%. In addition, in a randomized controlled study, MiniMed 780G showed a clinically significant 1.4% absolute improvement in hemoglobin A1C (“A1C”), as compared to the current standard of care as described above. A1C is measured with a blood test and is a representation of the average blood sugar over the previous three months. The ADA recommendation for A1C is <7.0%, or 53 mmol/mol.

A 2024 meta-analysis of competing systems showed that our MiniMed 780G systems outperformed against other competing products on TIR. We believe meta-analyses and comparisons of published real-world data are robust and valid ways to compare the glycemic outcomes of our devices with those of third-party devices. Peer-reviewed meta-analyses with broad acceptance criteria and analyses like random-effects frequentist network meta-analyses provide results with confidence intervals and offer robust statistical conclusions supporting comparison of devices using available clinical trial data. Further, large bodies of real-world evidence offer a strong means of mitigating these biases and normalizing many of the specific clinical and demographic variables that exist in the real-world use of AID systems.

While meta-analysis can provide valuable insights by aggregating data from multiple studies, this approach has inherent limitations. The methodology relies on indirect comparisons, which may introduce biases due to variations in study design, populations, and analytical approaches. Without direct comparative trials, differences in outcomes between interventions may not be adequately assessed, leading to potential uncertainties in the interpretation of results. Accordingly, investors should exercise caution when considering findings derived from meta-analysis as conclusive evidence.

Direct head-to-head clinical studies have not been conducted comparing modern AID systems at the time of this offering. Additionally, individual device clinical studies often offer small sample sizes with potential for investigator selection bias, volunteer bias on the part of the participant, and attention bias given the close follow-up during the trial. These biases, which are inherent in industry-sponsored trials, may result in a best-case scenario or non-representative outcome.

We believe our clinical performance is driven by our advanced SmartGuard dosing algorithms, which safely and automatically adjust insulin pump dosing every five minutes. An international group of experts in diabetes technology convened prior to the 2025 Advanced Technologies & Treatments for Diabetes (“ATTD”) Congress and recommended establishing a tighter glycemic goal referred to as time in tight range (“TITR”). The goal for the percent of time that PWD should be in that range was targeted to be >55% as of fiscal year 2025. The reason that there is a movement to tighten the recommendation is that 70-140 mg/dL range is close to “normal,” i.e., where glucose for people without diabetes resides 96% of the time. As of fiscal year 2025, which ended April 25, 2025, the MiniMed 780G is the only system on the market with published data on TITR showing >55% in children and adult ROS users (5.4% of children and 5.3% of adult users were ROS users), and TITR showing >48% in all children and all adults. Because it is a new guideline, TITR has not been consistently reported or addressed in studies assessing the performance of competing systems and therapies. We regularly review the scientific literature and published data of competing systems and determined that, as of the time of this offering, competing systems and therapies do not have published TITR performance data suitable for comparison. Therefore, we have concluded that the MiniMed 780G is the only system on the market with published data on TITR showing >55% in children and adults using the recommended settings.

In terms of user experience, the MiniMed 780G has maintained the number one pump satisfaction in the United States since Q2 2024, according to pump satisfaction survey results from dQ&A’s Q2 2025 U.S. Diabetes Patient Voice report. Our leading clinical and user performance has earned our status as a recognized and trusted brand in the diabetes space.

We continue to build on this position by developing innovative diabetes technologies that improve treatment and relieve burdens for PWD. Our global research and development function is focused on a number of priorities. We continue to execute on launches of our second-generation AID systems, which began with the European Union (EU) launch of our Simplera Sync CGM sensor in 2024 and has continued in the United States where we launched our Simplera Sync CGM sensor in September 2025. Along with Simplera Sync, we received U.S. Food and Drug Administration (“U.S. FDA”) clearance of our SmartGuard algorithm as an interoperable automated glycemic controller (“iAGC”) and MiniMed 780G as an Alternate Controller Enabled (“ACE”) pump, which will enable compatibility between the MiniMed 780G system and the Instinct CGM made by Abbott (“Instinct”), a CGM sensor supplied by Abbott Diabetes Care, Inc. (“Abbott”). We have also submitted for CE Mark approval. Our third-generation AID systems are designed to utilize each of these sensors, and include our smaller MiniMed Flex insulin pump, which we have submitted for U.S. FDA approval and plan to submit for CE Mark approval by the end of the first quarter of calendar year 2026, and our MiniMed Fit patch pump with extended wear, which we aim to submit for U.S. FDA approval by the fall of calendar year 2026 and CE Mark approval thereafter. Bringing together these important hardware improvements is our next-generation Vivera dosing algorithm, which meaningfully eliminates user intervention. With these innovations, we believe we are poised to extend our category leadership, driving toward a future where diabetes management can be “hands free” with simple, highly effective insulin dosing technology that safely and reliably delivers appropriate insulin doses and achieves glycemic targets for all.

We operate a scaled global commercial and manufacturing organization with our corporate headquarters in Northridge, California. We are led by a world-class senior management team and global employee base with a reputation for innovation and culture of accountability. Our commercial organization maintains relationships with over 40,000 prescribing HCPs globally, while coordinating our sales process from demand generation and marketing through fulfillment and renewals in the markets where we operate. Our AI-enabled sales force is powered by software such as our proprietary MiniMed IQ, which provides real-time physician landscape insights nationwide and optimizes our account targeting strategy, and third-party tools, which optimize our lead generation strategies and enhance our sales forecasting with predictive analytics. We operate two main manufacturing facilities in California and Puerto Rico, which serve as the backbone of our global operations, covering our manufacturing, distribution,

and sourcing functions. We have built up a large base of intellectual property, with more than 2,500 patents and patent applications across our markets as of October 2025.

In the six months ended October 24, 2025 and in fiscal year 2025, we generated $1.5 billion and $2.7 billion, respectively, in revenue, of which 83% and 80% came from sales of CGMs, other consumables, software, and services. We are unmatched in our global presence among our key competitors, with outside the United States (“OUS”) revenue representing 70% and 67% of our total revenue in the six months ended October 24, 2025 and in fiscal year 2025, respectively. We are the global leader in insulin pumps by users according to Seagrove Partners’ November 2025 GlobeVIEW Scoreboard, servicing more than 640,000 pump users in approximately 80 countries as of October 2025. In the six months ended October 24, 2025, we achieved Net Loss of $21 million and Adjusted EBITDA of $128 million. In fiscal year 2025, we achieved Net Loss of $198 million and Adjusted EBITDA of $253 million. Our Net Loss represented 1% and our Adjusted EBITDA represented 9% of our revenue during the six months ended October 24, 2025, and 7% and 9%, respectively, of our revenue during fiscal year 2025. We aim to achieve profitable growth with our strategy. For additional information about these non-GAAP measures, including a reconciliation of each of these non-GAAP measures to its most directly comparable financial measure calculated in accordance with U.S. GAAP, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Measures.”

Our Market

Overview of Diabetes

Diabetes is a chronic, lifelong condition characterized by the body’s inability to produce or effectively use insulin, a hormone essential for regulating blood glucose levels. There is no known cure, making proper management critical to avoid serious health complications.

Diabetes is typically classified into two major groups:

•T1D is an autoimmune condition which causes the body to attack insulin-producing beta cells in the pancreas. It is typically diagnosed in childhood or early adulthood. Since people with T1D are living longer than ever, the majority of people with T1D are adults. Individuals with T1D require daily insulin administration, or intensive insulin therapy, to manage their health.

•T2D is a metabolic condition that results from insulin resistance, where the body’s cells do not respond effectively to insulin, often accompanied by reduced insulin production over time. It is strongly associated with lifestyle factors, such as obesity, inactivity, and diet, although genetics also play a role. In some cases, T2D can be managed with changes to diet and exercise regimes; however, if the condition progresses, more active management such as insulin therapy may become necessary.

Diabetes is a widespread global epidemic that impacts a large and growing population. According to the 2025 IDF Diabetes Atlas, an estimated 589 million people are living with diabetes worldwide, and that is expected to grow to more than 850 million by 2050.

Diabetes Management

Conventional treatment options like MDI can be a burden on the quality of life for PWD. First, these options fail to deliver what we consider to be acceptable clinical outcomes. Second, these options require significant effort from users, meaning PWD have to deal with 24/7 administrative, physical, mental, and emotional burdens.

Outcomes: Although treatment options are generally widespread, a significant portion of insulin-dependent PWD are not achieving clinically recommended levels of glycemic control. About four out of every five T1D patients use a CGM sensor in developed markets, yet more than 74% of T1D patients in developed markets fail to meet glycemic targets, according to a study by Diabetes Technology & Therapeutics. The study also found that a cohort of people with T1D in 2022 achieved only an 8.4% mean A1C level, well above the ADA-recommended guideline of <7.0% A1C. The same 2022 cohort achieved only a minor improvement versus a 2016 cohort that

achieved a mean A1C of 8.7%, despite a significantly higher rate of technology utilization in the 2022 group (e.g., a 45% increase in the percentage using a CGM).

Burdens: Current options require constant monitoring, decision-making, and interventions by PWD and their families, leading to administrative, physical, mental, and emotional burdens. Examples of administrative burdens include carrying around supplies (glucose tabs, juice or snacks, back-up insulin, needles, lancets, spare sensors, pump supplies, batteries, etc.), reordering supplies, obtaining documentation for travel, going through secondary screenings with airport security, handling insurance, obtaining prior authorizations, and refilling prescriptions, among others. Physical burdens include fluctuating glucose levels (which may cause lethargy, difficulty in focusing, and/or frequent urination), having to eat when not hungry (to correct lows) or delaying meals (to wait for insulin to act), body image concerns (especially among teens and young adults), skin irritation or allergic reactions to adhesives, constant beeping/alerts (especially overnight, disrupting sleep), finger pricks (in the case of self-monitoring blood glucose, or “SMBG”), scar tissue, and wearing bulky and/or uncomfortable devices. Emotional burdens result from fear of going low while driving, during meetings, or during solo travel, burnout/fatigue from never being “off duty,” and PWD and their families worrying about unexpected episodes of severe hypoglycemia leading to the need for assistance, seizure or coma, and/or severe hyperglycemia that can lead to life-threatening ketoacidosis requiring hospitalization. Between 20% and 40% of people with T1D report emotional distress related to the burden of self-management. PWD also deal with decision-making burdens such as carb counting for proper insulin dosing, which we estimate more than 65% of PWD miscalculate.

Addressing these challenges is key for the success of our offerings. We do not believe a cure to diabetes is imminent, nor do we believe that cell therapies or GLP-1s represent a realistic solution for the large global population of people requiring intensive insulin treatment. Studies show both cell therapies and GLP-1s have been proven to be less cost-effective than AID systems, and still require access to treatments like AID or MDI as a backup matter. Cell therapies for T1D require costly drugs to suppress immune response. GLP-1 treatments for T2D patients requiring intensive insulin treatment may still require the use of glycemic management tools such as AID or MDI for most individuals.

Our Addressable Market

The primary addressable market for our solutions includes people with T1D and T2D who require intensive insulin therapy, as well as people with T2D requiring basal insulin titration. In total, we define this addressable market as the market for insulin-taking individuals. This population requires a combination of CGM or BGM and insulin pumps or MDI. This is our primary market and our core focus because it represents the population of PWD who most value and utilize the technology we provide. Our addressable market is expected to grow at a compound annual growth rate above 10% from 2025 through at least 2030, according to Seagrove Partners’ November 2025 market model. Our market exhibits many of the same secular growth drivers as the broader disease population, including prevalence of Western diets and healthcare development in emerging markets. Although smaller than other segments of the broader diabetes market by population size, we believe our primary addressable market has the highest utilization of diabetes management solutions and advanced technology and is the most likely to have reimbursement coverage in developed markets. This is because the patients in our addressable market lack natural ability to produce sufficient insulin levels on their own and thus have the strongest clinical need for insulin therapy to enable the prevention and reduction of life-threatening complications that can occur from insufficient insulin levels (which in turn is essential for reducing overall long-term costs to the healthcare system):

Figure A

Worldwide, according to Seagrove Partners’ November 2025 market model, it has been estimated that there are over 37 million PWD requiring intensive insulin therapy, with approximately ten million people in the top developed markets with the largest diabetes populations, including the United States, Canada, Australia, Japan, and major countries in Western Europe. Seagrove Partners also estimated that there are approximately 33 million additional people with T2D who require basal insulin, with approximately nine million people in the top developed markets with the largest diabetes populations, including the United States, Canada, Australia, Japan, and major countries in Western Europe. In total, we estimate the current market for our diabetes technologies and other offerings to be over $18 billion, based on last twelve months ended September 2025 revenue from public filings of leading diabetes device manufacturers as identified by Seagrove Partners. As of the time of this offering, we utilize a dual-channel approach in the United States where we distribute the majority of our products through the DME channel and only a small percentage of our products through the pharmacy channel, whereas our market estimate includes companies that have broad coverage in the pharmacy channel. We expect this market size will continue to grow due to increasing adoption of advanced diabetes management technologies, like ours, which are currently underpenetrated in the market. The MiniMed 780G system is approved for use by people with T1D and insulin-requiring T2D in the United States and EU.

Growth Opportunity for Advanced Technologies

We believe the main driver of our market’s expected rate of growth is increased penetration of Smart Dosing solutions, such as AID, over traditional therapies like unconnected MDI or standalone CGMs. Smart Dosing solutions integrate accurate, real-time blood glucose measurements with technology automation applications, like AID and Smart MDI (software-connected injection device systems), enhanced with advanced dosing software and algorithms. Smart Dosing technologies, particularly AID, are designed to provide an “artificial pancreas” solution that dramatically simplifies diabetes management and insulin therapy for PWD. They are becoming the gold standard of care in our space because of their proven ability to improve clinical outcomes and reduce user burden.

The global community is taking notice of the improvement from using AID systems compared to conventional treatment, with organizations worldwide increasingly recommending AID as a first-line therapy. For example, the ADA recommends that AID systems should be offered to youth and adults with T1D early, even at diagnosis. Additionally, the ATTD consensus report recommends AID systems should be considered for all people with T1D,

especially those with suboptimal glycemia, problematic hypoglycemia, and/or significant glycemic variability. It also recommends that all payors should cover AID systems along with initial and ongoing training and education for people with T1D. Lastly, International Society for Pediatric and Adolescent Diabetes (“ISPAD”) clinical practice consensus guidelines have stated that AID systems improve TIR by minimizing hypoglycemia and hyperglycemia, are especially beneficial in attaining targeted glycemia in the overnight period, and are strongly recommended for youth with diabetes. These technologies continue to improve as well, with innovations like more simplified pump systems, easy-to-use CGMs, and AID algorithms, according to Seagrove Partners’ November 2025 market model.

According to the same market model, most PWD taking insulin in OUS developed markets (defined to include Canada, Australia, New Zealand, Japan, South Korea, and major countries in western Europe) utilize a standalone CGM with MDI that is not connected to their insulin dosing solution. Similar to the United States, most PWD with intensive insulin needs in developed markets are not using Smart Dosing solutions. Specifically, only 26% of T1D patients (approximately 800,000 out of 3.0 million in total) and 6% of insulin-requiring T2D patients (approximately 200,000 out of 3.2 million in total) use AID systems in these OUS developed markets. Emerging markets show even less penetration of advanced technologies: less than 3% of T1D patients (approximately 300,000 out of 12.0 million in total) and less than 1% of insulin-requiring T2D patients (approximately 140,000 out of 14.0 million in total) use AID systems in OUS developing markets (defined as all markets other than the United States and OUS developed markets). The implication is that the vast majority of PWD today rely on manual, error-prone, and burdensome methods of estimating, calculating, and dosing their daily insulin. There are over 15 million patients currently on MDI that could benefit from AID in the future, according to Seagrove Partners’ November 2025 market model.

We believe that the adoption of Smart Dosing technologies has room for growth. While some existing products may be seen as complex, costly, and not meaningfully more effective than alternatives, this opens the door for innovation to enhance these technologies in ways to better serve PWD and HCPs who prescribe these devices. For example, current AID systems on the market still require manual meal announcements, requiring PWD to estimate carbohydrates, be proficient at using technology or require physicians to make many adjustments to device settings, and attend to administrative diabetes management tasks—there is potential for a more intuitive, “hands-free” experience. Moreover, in the United States, some of the providers who treat this population are PCPs, not diabetes specialists. These PCPs often do not have the specialty knowledge, resources, or bandwidth to prescribe complex devices. This presents an opportunity to simplify these solutions, making them more accessible and easier to prescribe, ultimately enhancing support for both PWD and HCPs.

With advanced technologies to offer, organizations like ours focus on closing education gaps among HCPs and PWD who are less familiar with new technologies. In doing so, we believe companies like ours have the potential to overcome perception barriers around clinical performance and technology simplicity.

Our Products and Offerings

Our Company strives to provide a holistic diabetes management ecosystem for our customers. We provide optionality and choice to our customer base, offering different form factors and treatment options which use integrated service channels that create one point of contact for all customer needs.

Our primary mission is to make every day a better day for people with diabetes. We do this by providing a comprehensive suite of Smart Dosing systems that are easy to use, automated, clinically superior to conventional treatment paradigms, and fully integrated. We are currently the only medical technology company in the diabetes space to commercialize a complete system, owning and innovating on all aspects of diabetes management systems for over 40 years. We offer two types of systems for people with insulin-requiring diabetes: AID and Smart MDI.

Automated Insulin Delivery (AID) System

The MiniMed 780G is our flagship AID system, which we believe most closely mimics how a healthy pancreas functions compared to other options available on the market today. Using our Meal Detection technology, it automatically adjusts and corrects every five minutes, providing as much insulin as needed, and exceeding the internationally recommended clinical outcomes for most patients. We are the first and currently the only company to commercialize a complete AID system comprised of an insulin pump, advanced dosing algorithm, the Simplera Sync CGM sensor, the MiniMed Extended Infusion Set, and the MiniMed Extended insulin reservoir.

The MiniMed 780G system has provided unparalleled clinical outcomes and is easy to use for PWD, caregivers, and healthcare teams. A person with diabetes using the system simply glances at his/her glucose and estimates carbohydrates a few times per day and the system does the rest. If the user forgets to enter his/her carbohydrates, the system’s patented Meal Detection technology automatically corrects glucose without alerting the user or requiring any effort from the user. Minimal to no action is required by caregivers because the system takes care of background and bolus insulin as needed. If desired, they may follow remotely with the CareLink Connect App. Finally, the MiniMed 780G system requires very little set-up/follow-up for healthcare teams. There are only three settings which impact insulin delivery and few, if any, changes are needed to the settings after system initiation. Moreover, the MiniMed 780G system with a seven-day-wear infusion set (based on maximum potential wear time as described in the 780G user guide) and 15-day Instinct CGM is designed to require only six injections per month, compared to as many as an estimated 12 to 18 injections per month when using competing AID systems from Tandem (for example, based on labeling of Tandem’s insulin pump infusion sets for up to three days of wear and Dexcom’s G7 CGM for up to 15 days of wear) and Insulet (for example, based on labeling of Insulet’s Omnipod 5 patch pump for up to three days of wear and Dexcom’s G6 CGM for up to ten days of wear, as well as data demonstrating that many pump users use an average total daily dose of insulin that exceeds the maximum total daily dose required to make three-day wear with Omnipod 5’s 200-unit reservoir possible). The 780G system is not only simple for PWD, their caregivers, and their healthcare team, it also delivers unmatched clinical outcomes, helping PWD live healthier and easier lives.

The MiniMed 780G system consists of the following components:

The MiniMed 780G insulin pump is our second-generation insulin pump, offering enhanced functionality and technological integration with other components of our 780G system. It features a low glucose target setting (as low as 100 mg/dL) that closely mirrors the average glucose of someone not living with diabetes. With this setting, the pump will “treat to target” and will automatically and safely deliver basal insulin adjustments and autocorrections to a set target. The pump does not need to be left to charge, as the user simply needs to replace the AA batteries whenever necessary. Additionally, the pump features a companion mobile app that makes it easy for users to discreetly monitor their glucose levels and insulin pump data, receive notifications, and automatically upload data to the CareLink cloud. The product received CE Mark approval in June 2020 and U.S. FDA approval in April 2023.

The Simplera Sync CGM sensor is an easy-to-use, two-step insertion sensor that is fully disposable, worn on the arm, and can last for up to seven days of continuous sensor readings. It is small and able to be worn discreetly, engineered to comfortably withstand normal daily activity without coming off. Usage and insertion are easy, and the product requires no calibration. The Simplera Sync CGM sensor received CE Mark approval in September 2023 and U.S. FDA approval in April 2025. We believe the improved design and ease of use of Simplera Sync will help accelerate penetration of the 780G system.

The Instinct sensor is an alternative CGM sensor based on Abbott’s most advanced single-analyte CGM technology. Instinct features easy one-handed insertion, small and discreet wear, 15-day wear time, one hour warm-up, and no overtape. The MiniMed 780G system is designed to ensure seamless integration with Instinct. The MiniMed 780G received U.S. FDA clearance as an ACE pump in July 2025, and our SmartGuard algorithm received U.S. FDA clearance as an iAGC in September 2025. We have also submitted for CE Mark approval.

The MiniMed 780G system uses our SmartGuard dosing algorithm technology, which automatically delivers basal insulin and auto-correction doses every five minutes based on sensor glucose readings. Additionally, every night the algorithm updates to adapt to ongoing changes in user behavior patterns. Compared to other systems, SmartGuard technology is able to dose more insulin safely, early, and often when sensor glucose is trending to higher levels to avoid hyperglycemia without increasing the risk of lows. Up to 288 automatic adjustments can be made on a daily basis. With our Meal Detection technology, the system also uses current and past sugar trends to detect a missed meal dose. When a user forgets to bolus, if the system detects a meal based on the rapid rise in sugar levels, it will automatically deliver correction doses while sugar levels are rising, up to every five minutes, to help bring the user back to target.

As part of the MiniMed 780G system, we offer a broad portfolio of infusion sets and reservoirs available to match different patient body types and lifestyle needs. Our latest model is the MiniMed Extended Infusion set,

which was the first commercialized infusion set to last up to seven days. This long-wear system eases the burden on PWD, allowing for fewer set changes and decreasing the burden of finding new infusion sites on their body. This set complements our Simplera Sync sensor, as users can replace them at the same weekly cadence. In addition to this model, we offer additional products to meet the diverse needs of PWD. For those with needle anxiety, we offer the MiniMed Mio Advance infusion set with an all-in-one insertion design. For those with allergies, we offer the MiniMed Sure-T infusion set, which uses a steel needle rather than a cannula.

The MiniMed 780G system has demonstrated the ability to significantly reduce burdens and improve outcomes relative to other treatment options available today, earning the highest satisfaction ratings among AID systems according to pump satisfaction survey results from dQ&A’s Q2 2025 U.S. Diabetes Patient Voice report, and has proven to reduce effort required for many patients and result in a higher quality of life. Additionally, the system has delivered superior outcomes for diverse populations, including high-risk adolescents, the technology naive, and patients new to insulin pump therapy.

In the United States, the MiniMed 780G system is indicated for use by T1D patients seven years of age and older and insulin-requiring T2D patients 18 years of age and older. In the EU, the MiniMed 780G system is indicated for use by T1D and insulin-requiring T2D patients two years of age and older, as well as pregnant women. As of October 2025, we have more than 640,000 customers in approximately 80 countries on the system. We also offer compatibility with our MiniMed Guardian 4 sensor, Simplera Sync, and major smartwatch platforms. The MiniMed 780G system is intended for use with rapid-acting U-100 insulins (Admelog, Humalog, and NovoLog) and ultra-rapid-acting U-100 insulins (Fiasp and Lyumjev) in the United States and EU. In addition to the MiniMed 780G system, we offer prior versions of our AID system including MiniMed 770G, MiniMed 740G, and MiniMed 720G in select markets based on access and market need, which all have a connected CGM and smartphone compatibility.

Smart Multiple Daily Injection (MDI) System

For PWD that choose to manage their diabetes with MDI instead of an insulin pump, we offer our Smart MDI system. Smart MDI helps limit the guesswork typically required for manual insulin dosing to help PWD deliver the appropriate dose at the appropriate time and improve health outcomes relative to patients who only use a CGM sensor. Studies have indicated that our Smart MDI system can deliver a 70.3% TIR and a 13% reduction in hypoglycemic events relative to baseline.

The system is comprised of the MiniMed InPen (a Bluetooth-connected smart insulin pen), the MiniMed Simplera CGM (a user-friendly and fully disposable seven-day CGM), and an integrated management app. The Smart MDI system works by reading the glucose levels of the user from the CGM and recommending the appropriate amount of insulin to take via the InPen. Critically, this is the first and only system available today that tracks and measures both insulin dose delivered and glucose data to deliver personalized, real-time dosing recommendations so that PWD using the system can take the exact dose they need. This system is also compatible with the MiniMed Guardian 4 sensor and is indicated for insulin-taking PWD seven years of age and older. For patients who fear needle injections or desire a more comfortable injection experience, we also offer i-Port Advance, a three-day, simple-to-apply, and fully disposable injection port.

CareLink

CareLink is the software platform that provides support for PWD, their caretakers, and HCPs to help manage diabetes treatment. CareLink aggregates disease management data points, such as real-time CGM readings and insulin dosing logs, to generate actionable insights that can help improve health outcomes. Since the platform’s inception in 2006, we have continued to enhance its functionality with regular updates.

The CareLink patient dashboard improves efficiency by providing easy access to data to assess therapy management performance at a glance, displayed in a single, interactive view. This includes a 24-hour sensor glucose overview to show users how they are doing in managing their treatment and whether adjustments or changes need to be made. PWD, their caretakers, and HCPs can get updates on key performance indicators, tracking trends and changes in glucose, TIR, extreme glucose levels, and device usage. Using CareLink monitoring data, the My Insights program provides PWD with automated, personalized insights and encouragement, which we expect to

incorporate as in-app nudges in upcoming CareLink development milestones. With the patient dashboard, providers can remotely monitor key data points for all their patients in one view, including TIR, insulin delivery, and device usage. This platform simplifies HCPs’ workflow, helping to prioritize which of their patients need the most support and facilitating more efficient allocation of time and resources to help HCPs run their practices more effectively.

Clinical / Real-World Evidence

Our commitment to PWD has always been to create a smarter and easier future for PWD, which has driven our organization to develop what we believe is currently the world’s best AID system, the MiniMed 780G. The 780G has consistently demonstrated superior glycemic control, clinical efficacy, and cost-effectiveness compared to other diabetes treatment options, including competing AID systems based on real-world data and literature meta-analyses. Additionally, the 780G’s ability to manage basal and bolus insulin delivery without any action required greatly eases the burden of managing diabetes. The clinical and real-world evidence base for the 780G is robust, consisting of eight randomized clinical trials, nine health economics analyses, over 200 peer-reviewed publications, and real-world evidence based on approximately 400,000 PWD. The breadth and depth of this data reinforces our belief that the 780G is the most advanced technology in diabetes, improving the lives of PWD, their families, caregivers, and HCPs who care for PWD.

•The 780G has Improved Glycemic Control versus the Current Standard of Care: The ADAPT study is the first multi-national randomized control study evaluating the performance of the 780G system versus standard of care (MDI + intermittently scanned CGM (“isCGM”)) in individuals with T1D who were poorly controlled (A1C of 9% at baseline) despite scanning their glucose levels at least five times per day. At six months of this study, A1C had decreased by around 1.54% to 7.32% for 780G users, compared to a decrease of around 0.2% to 8.91% for users of MDI + isCGM. The use of the 780G system in this study demonstrated the benefits in glycemic outcomes and users’ satisfaction beyond those that can be achieved with MDI + isCGM. Additionally, significantly more users on the 780G achieved the TIR and A1C targets than users on MDI + isCGM. This data supports providing access to our advanced hybrid closed-loop system in people with T1D who are not at target glucose levels. On average, participants using the MiniMed 780G system reported improved quality of life as measured in decreased social worry and diabetes worry, as well as increased treatment satisfaction, impact, and general well-being.

•The 780G’s Superiority has been Further Supported by Real-World Evidence: Real-world evidence from a global dataset of approximately 400,000 users demonstrated that the 780G can help improve outcomes for people living with T1D by safely achieving glycemic targets. Overall, 67% of MiniMed 780G ROS users (16% of all users were ROS users), and 47% of all MiniMed 780G users, achieved the combined glycemic targets of TIR above 70%, Time Below 70 mg/dL below 4%, and Time Below 54 mg/dL below 1%. Mean TIR was 77.5% and mean glucose management indicators (“GMI”) was 6.8% for ROS users, and 72.1% and 7.0% for all users. GMI is a population-based estimate of A1C based on mean GCM glucose that is widely accepted as an indicator in the diabetes industry. The 780G also has consistent outcomes in diverse populations of users across age, gender, geography, and prior levels of glycemic control. In a published longitudinal study of real-world evidence collected from over 100,000 MiniMed 780G users across 34 countries in Europe, the Middle East, and Africa (“EMEA”), the glycemic outcome results were sustained over a 12-month observation period, which was the clinical endpoint of the analysis.

•The 780G’s Ease of Use Can Reduce the Burden of Managing Diabetes: The 780G’s ease of use also benefits people who have no prior experience with pump therapy—specifically, users who are on MDI + SMBG. Based on a two-center, randomized control study with 37 participants, users who switched from MDI + SMBG to the 780G experienced a 16% increase in TIR to 85%, with significant improvements in A1C levels from 7.05% to 6.7% and in quality of life. 100% of the 780G users achieved ADA-recommended TIR or better compared to only 29% for MDI + SMBG users.

•The 780G System Can Improve Outcomes for Diverse Populations of PWD: The 780G has been proven to work for people across diverse socioeconomic backgrounds, as defined by the area deprivation index (“ADI”) score, a composite metric of socioeconomic status based on income, housing, employment, and education. Based on real-world evidence from over 39,000 780G users who lived in the United States,

glycemic control results were similar regardless of socioeconomic status, with all ADI groups achieving an average 7% GMI.

•The 780G System Can Improve Outcomes for Diverse Populations of PWD: The 780G has shown to be an effective therapy for diverse groups of people, delivering international consensus-recommended glycemic control. Regardless of age, gender, race, socioeconomic backgrounds, or culture, our AID system has proven to achieve meaningful improvement in glycemic levels.

•The 780G System Has Delivered Best-in-Class Glycemic Control Outcomes Over Current AID Systems and Insulin Pumps: According to a meta-analysis of 28 randomized control trials of people with T1D, 780G users achieved the highest TIR across all users of tested AID systems. In addition to clinical studies, based on published real-world data, the 780G has proven to help its users maintain the closest TIR to a healthy pancreas compared to competing AID systems. A healthy pancreas maintains a TIR of 95%+. Acknowledging differences in patient age distributions can impact sustained TIR results in real-world data, in a longitudinal global real-world evidence dataset comprised of approximately 400,000 users spanning pediatric to adult patients, the 780G system has been proven to maintain a median TIR of 75-78% across pediatric and adult ROS users (comprised of over 65,000 users) as compared to published real-world evidence showing a median TIR of 65-70% across pediatric and adult age groups using the lowest glucose target for Insulet’s Omnipod 5 (54% of users used the lowest glucose target, and median TIR was 61-66% for all users) and, for Tandem’s Control-IQ, a median TIR of 72% for all patients and, in a separate 12-month observational study, a median TIR of 61-70% across pediatric and adult age groups. In the same data, for patients using 780G, 80% of all ROS users achieved the consensus target of TIR over 70%, as compared to 46% with the lowest target glucose setting for Insulet’s Omnipod 5. The percentage of patients using Tandem’s Control-IQ that achieved the consensus target of TIR over 70% was not specified.

Data for this comparison is based on Insulet’s Forlenza 2024 study, Tandem’s Messer 2023 study, and Tandem’s Graham 2024 study (each as defined in the section of this prospectus entitled “Market and Industry Data”), which we believe are comparable to our real-world data because they are also relatively large real-world datasets with diverse populations spanning pediatric and adult patient ages, but differ in that they are limited to U.S. patients. Additionally, while Tandem’s Graham 2024 study is longitudinal and discloses outcomes for pediatric and adult age groups, it has a comparatively smaller sample size, and while Tandem’s Messer 2023 study has a comparatively larger sample size, it is not longitudinal and does not disclose outcomes by age groups.

The Pöhlmann 2025 meta-analysis, a systematic literature review and meta-analysis of 34 real-world studies conducted by external researchers in collaboration with Medtronic, evaluated glycemic outcomes across major AID systems. This independently executed analysis included data from more than 635,000 users. The study explores comparative performance outcomes for Medtronic’s MiniMed 780G, Tandem’s Control-IQ, and Insulet’s Omnipod 5 systems, among others.

The Pöhlmann 2025 meta-analysis found that the MiniMed 780G achieved the highest pooled TIR, outperforming both Control-IQ and Omnipod 5, while also demonstrating lower time above range and more consistent performance across geographies and age groups relative to other systems. MiniMed 780G ROS users achieved a mean TIR of 79.6%, which was 11.9% higher than the mean TIR of 67.7% achieved by Omnipod 5 ROS users. The overall (using any settings) TIR results showed that MiniMed 780G users using any settings achieved an unweighted mean TIR of 73.8%, which was 13.8% higher than the mean TIR of 60.0% achieved by Omnipod 5 users using any settings. ROS users comprised 6.5% of MiniMed 780G users and 53.3% of Omnipod 5 users.

•The 780G Can Be Cost-Effective: The 780G can be a cost-effective way to manage diabetes and provide both long- and short-term economic benefits to PWD and healthcare systems. An analysis of data sourced from the ADAPT trial showed that 780G could potentially generate long-term savings, versus traditional therapies, of up to €43,000 per quality-adjusted life year (“QALY”) by reducing diabetes-related complications in people with T1D with suboptimal glycemic control. A separate analysis established that use of the MiniMed 780G system was associated with an estimated 2.26 additional QALYs compared with

isCGM plus MDI therapy in France, reflecting projected reductions in long-term diabetes complications and improved overall health outcomes.

Innovation / Pipeline and Future Initiatives

Overview

We plan to continue our track record of creating disruptive technologies in the diabetes industry with our rich pipeline including the MiniMed Go, our next-generation MDI system with single app integration; the MiniMed Flex, our smaller, screenless, newly designed insulin pump; our MiniMed Fit patch pump with extended wear; and our next-generation Vivera dosing algorithm. In addition, we received U.S. FDA clearance of our SmartGuard algorithm as an iAGC and MiniMed 780G as an ACE pump that are both compatible with Instinct, an alternative CGM sensor that will provide greater customer choice and flexibility. These low-burden, easy-to-use, and consumer-friendly products are expected to be wrapped around a unique software system that we are designing to allow the user to switch easily between devices to customize their treatment with a desired system solution combining these technologies.

Figure B

We illustrate our historical and future evolution treating PWD with our products in the three stages below. Our MiniMed 670 system with Guardian sensor represented our first generation of products in AID—products that were first to market and transformed the lives of many PWD but still required some manual input. We believe that with the MiniMed 780G system and Simplera Sync CGM sensor, we are currently in the second generation of products in AID. With our improved dosing algorithm and CGM sensor, we believe we have enhanced the overall user experience. In the near future, subject to regulatory approval, we plan to globally introduce our new insulin pump, our next-generation Vivera dosing algorithm, improved Simplera Sync CGM sensor, and Instinct, ultimately providing what we believe will have the potential to be the best performing and easiest-to-use “hands-free” AID user experience in the market.

Second-Generation AID Expansion

After launching our MiniMed 780G system, latest InPen system, Simplera Sync, and Simplera CGMs, our remaining second-generation AID initiatives represent initiatives where we plan to leverage our current products, including our pioneering and industry-leading dosing algorithm, based on TIR outcomes in real-world data, and system data, to expand our indications and improve the user’s sensor experience.

We continue to seek approval for additional indications for the MiniMed 780G system to further expand our total addressable market. For example, in fiscal year 2026, we received U.S. FDA and CE Mark approval for use of the MiniMed 780G system by insulin-requiring T2D patients. We believe the insulin-requiring T2D population is vastly underpenetrated around the world and well-suited for the MiniMed 780G system. For the last twelve months ended October 24, 2025, approximately 40% of new U.S. patients on our insulin therapies (AID or Smart MDI) were T2D patients.

Third-Generation AID Pipeline

With our third-generation products, we plan to introduce a comprehensive platform that will unify our products through a modernized and consistent app that will connect the user, HCPs, and caregivers. We believe this comprehensive platform will help address the different needs and preferences of this population, while simplifying their therapy options and data management to one source.

MiniMed Flex Pump

MiniMed Flex is our planned next-generation tubed insulin pump for PWD. With its reduced size, sleek design, seven-day-wear infusion set, and smartphone control, we believe MiniMed Flex offers superior benefits:

•Improved hardware experience and design that is 50% the size of the current MiniMed 780G

•Simplified app experience

•Access to best-in-class algorithm

•Simplified training experience

We anticipate the MiniMed Flex will work with our Simplera Sync sensor as well as Instinct. We have submitted the MiniMed Flex for U.S. FDA approval and plan to submit for CE Mark approval by the end of the first quarter of calendar year 2026.

Sensor Flexibility with Instinct

In addition to Simplera, with our third-generation of products, we are introducing an alternative CGM with our global partnership with Abbott. Abbott will supply us with Instinct, an alternative CGM sensor based on Abbott’s most advanced single-analyte CGM technology, and will be the exclusive supplier of third-party CGMs for certain of our AID and Smart MDI systems. These systems are designed to ensure seamless integration with Instinct. We received U.S. FDA clearance of our SmartGuard algorithm as an iAGC and MiniMed 780G as an ACE pump, which will enable compatibility between the MiniMed 780G system and Instinct. We have also submitted for CE Mark approval. Instinct is exclusively integrated with MiniMed devices and algorithms and is based on an Abbott CGM that has U.S. FDA and CE Mark approval. The combined solution of Instinct with MiniMed 780G as an integrated system creates a new product offering that expands treatment options for MiniMed users.

We believe integrating Instinct into our AID and Smart MDI systems allows us to expand access for PWD by combining our advanced insulin dosing solutions with the most widely used CGM technology in the world. We look forward to offering our Simplera platform alongside Instinct to bring more choice to PWD within one seamless MiniMed experience.

AID and Smart MDI Expansion

MiniMed Go Smart MDI

We are progressing several enhancements to our Smart MDI system with our next-generation MiniMed Go system. MiniMed Go is our next-generation Smart MDI system and is expected to offer: a simple, self-start smart insulin pen; a single, fully integrated app; and full integration with the Simplera Sync and Instinct CGMs. The MiniMed Go app has received U.S. FDA clearance and CE Mark approval.

MiniMed Go will be focused on enhancing and simplifying the user experience, including by providing proactive and predictive dosing recommendations, automating glucose level prediction in the background, and prompting the user to bolus or correct before he or she risks becoming hyperglycemic. We believe MiniMed Go will have the ability to deliver improved outcomes over CGM alone providing an option for those not interested in a pump. In the United States, we expect MiniMed Go to be distributed initially through the pharmacy channel.

MiniMed Fit Patch Pump

MiniMed Fit is our planned patch pump and is intended to offer an alternative form factor to our tubed pump. We expect that MiniMed Fit will offer a discreet, convenient diabetes product with the potential for extended wear time (up to seven days), large reservoir (300 units), and smartphone control. In addition, the MiniMed Fit patch pump’s differentiated two-piece design operates quietly and reduces waste, with a reusable component containing the rechargeable battery and high-resolution electronics, and a consumable or disposable component containing the insulin reservoir and on-body adhesive.

We believe MiniMed Fit will be attractive to both the T1D and T2D populations given its reservoir size and days of wear. We also believe the product will be positioned to enhance our U.S. pharmacy channel strategy.

Next-Generation Vivera Dosing Algorithm

We are working to extend our category leadership with our next-generation Vivera algorithm which we expect will enable a “hands-free” AID system that can safely and reliably deliver the right doses of insulin at the right time with just one total daily dose setting, and without any regular user input. This next-generation algorithm is being designed to minimize the burden of managing diabetes by eliminating carb counting and manual food bolusing while allowing the user to maintain class-leading and consensus-recommended levels of glycemic control, with flexible targets of 90-140 mg/dL. We believe our algorithm will be highly differentiated among the algorithms currently in the market, minimizing input by the user and the provider. In feasibility study data for adults, the Vivera algorithm without manual user input achieved a mean TIR of 73.8%, with 75% of participants exceeding ADA guidelines of TIR >70%. For adult users seeking even tighter glycemic control, the Vivera algorithm with optional user carb counting achieved a mean TIR of 82.3%, with 92% of participants exceeding ADA guidelines of TIR >70%. The adult feasibility study data was collected from 24 patients with T1D currently using AID therapy, assumed to be sufficient to establish feasibility, across two studies conducted in Israel and New Zealand between April 2025 and August 2025. The feasibility study protocols used were not designed to prove statistical significance. We expect to begin the U.S. pivotal trial for our Vivera algorithm in the first quarter of calendar year 2026.

Next-Generation Software and Services

As part of our third-generation AID pipeline as well as our Smart MDI expansion, we plan to simplify the patient and HCP experience through a unique software system to allow users to switch easily between devices. This unified app experience will allow users to transition seamlessly across all of our insulin delivery offerings (tethered pumps, patch pumps, and smart pens) as well all of our CGM offerings, all with a common and familiar user interface both for daily diabetes management as well as for HCP care management. As new hardware platforms are launched, integration into the unified app is expected to follow after launch. This data mobility and portability across all of our products means a patient’s data, inclusive of their diabetes management history and therapy settings, will go with them and enable interchangeable switching depending on lifestyles and device form factor preferences. This will unlock total therapy management from one smart device plus easy access for care partners in and outside the clinic.

Our Commercial Organization

We believe our commercial and service capabilities, scaled manufacturing capabilities, and broad and deep commercial reach provide us with a key competitive advantage among leading diabetes device manufacturers and the ability to realize durable growth at scale over the long term, as improving standards of care proliferate globally.

Our global commercial operations consist of over 3,000 employees as of May 2025. Our customer care and technology support operations represent over 1,100 employees across our commercial functions, with scaled global call centers that support 25 different languages on a 24/7/365 basis. Our reach, access, and relationships within the physician community have been cultivated over decades of strong partnership. We believe our omnichannel B2B2C marketing capabilities, digital and in the field, strong relationships in the diabetes community, and global brand reputation position us as the preferred customer choice throughout the entire customer journey.

Our sales infrastructure includes territory managers who support over 40,000 prescribing HCPs, primarily endocrinologists and diabetes educators, as of April 2025, and who have built deep relationships with key opinion leaders (“KOLs”). We consider this breadth to be a key growth enabler in our market, as our engagement with these clinical professionals helps to proliferate broader understanding and appreciation of our differentiated clinical data and user experience.

Globally, the diabetes market is very heterogeneous, requiring highly specific yet broad expertise in order to operate and succeed. A considerable portion of our sales have come from EMEA. This region is highly diverse, where there are nuanced differences in sales process and country-specific factors like tenders, vendor rankings for access, and varying levels of government involvement in procurement, fulfillment, and reimbursement.

For example, in Italy, its national health service delegates procurement to 19 regions and two autonomous provinces, within a tender framework. Across Italy, our business achieved a greater than 95% sensor adoption rate for those customers who used our insulin pumps in fiscal year 2025, and has been ranked as a number one or two leading brand for insulin pump users in each of the 2022-2024 dQ&A Italy Patient Voice surveys. We achieve this through a local tailored approach to HCP advocacy, partnering with around 300 patient groups and 2,000 HCPs as of April 2025, given Italy also limits digital marketing and advertising activities.

In contrast, France delegates procurement, fulfillment, and training to private service providers, with whom we negotiate pricing and supply agreements. These service providers are also the only parties that can have direct patient contact, meaning demand generation activity generally focuses on making our economic case to the service providers and HCPs, while also using more social media and press to highlight our products and brand instead of conducting field clinical sales activities.

Our European commercial organization is large, supporting thousands of HCPs, and boasts a long tenure of experience in the diabetes industry. We have built a large patient advocacy organization inclusive of partnerships with national, regional, and local associations. As of fiscal year 2025, we have developed deep relationships with KOLs, including 60 regional KOLs, over 100 additional country-level KOLs, and a team of patient advisors in the region who help to drive advocacy. We also strategically leverage our large digital footprint in these markets in compliance with country-level regulations regarding digital marketing activities. Customers in EMEA also value our integrated system sale and related wraparound services. We offer a number of digital care management platforms, training, and onboarding tools, and in some countries are able to offer our devices and related services in a bundled subscription offering.

Our Competitive Strengths

We believe the following strengths provide our business with significant, lasting advantages:

Unique and differentiated technology system delivering superior health outcomes and reducing diabetes disease burden for patients

We are the only player that independently commercializes a fully integrated Smart Dosing system by offering all the components required, including the capability to produce pumps and insulin pens, CGMs, other consumables,

dosing algorithms, software, and applications, as well as wraparound system support. Our fully integrated system addresses two key pain-points for PWD: health outcomes and complexity of diabetes management.

Addressing Health Outcomes: Our systems have consistently delivered superior clinical outcomes across diabetes populations, with a robust body of clinical evidence from controlled studies as well as real-world outcomes supporting our ability to improve glycemic control when compared to competing Smart Dosing systems as well as traditional therapy treatment options, including MDI with an unconnected CGM. Driving these better outcomes is crucial to relieving users of the serious comorbidities and health risks associated with diabetes—renal disease, blindness, nerve damage, and cardiovascular disease risk, among others. In addition to clinical studies, health economics studies have shown that our products also are associated with higher life expectancy and better cost-effectiveness versus traditional therapies. We believe the key to delivering these outcomes is our robust dosing algorithm, which was built with the benefit of hundreds of millions of patient data points accumulated over our years of operation.

Addressing Complexity: We address complexity by offering a simple solution and customer experience that removes some of the constant administrative, physical, mental, and emotional burdens associated with managing diabetes. We believe our robust and forgiving algorithm is the market leader in effectiveness based on the results of our clinical studies. It can adjust for the occasional missed meals and deliver autocorrections to keep patients in a healthy glycemic range. As the only medical device company that commercializes all the components of a full Smart Dosing system, our solutions are designed to integrate best and work better together. For example, the CGM and pump connect seamlessly without line-of-sight issues. Our customers have a single vendor and point of contact for their technology needs, further simplifying their disease management and reducing burden. We operate scaled global call centers, available on a 24/7/365 basis and supporting 25 different languages, with a single customer service line that handles issues for patients with any element of their diabetes management system. We offer a comprehensive range of treatment options, enabling user choice without sacrificing technological connectivity. Our CareLink software is fully compatible with our insulin pump, smart pen, CGMs, and other consumables, providing a solution for HCPs to manage their clinics more effectively and for users and their caretakers to track their therapy easily.

The global leader in diabetes medical devices with the largest number of pump users, broad and deep commercial reach, and scaled manufacturing capabilities

Among leading diabetes device manufacturers as identified by Seagrove Partners, we have the largest global footprint in our industry, operating in approximately 80 countries, and with more than 640,000 pump users as of October 2025. According to Seagrove Partners’ November 2025 market model, Insulet, Tandem, Ypsomed (now known as mylife Diabetes Care), and Beta Bionics, which we believe represent our closest insulin pump competitors, operate in 16, 23, 16, and one countries, respectively. We deliver on our mission with a well-invested, global, and experienced employee base of approximately 8,000 dedicated employees globally, including over 3,000 commercial employees, and two world-class dedicated manufacturing facilities. Commercially and operationally, our scaled global infrastructure creates a significant barrier to entry, given our decades-long presence operating outside of the United States. We have produced over five million insulin pumps since 2001. We have experience navigating numerous distinct local regulatory and reimbursement regimes and have made a significant level of upfront investment that is required to establish footholds in our markets. As we go to market, we promote education in AID, expand availability of our products in the United States across distribution channels and health plans, and are differentiating ourselves outside of the United States in national tender regimes.

Significant body of compelling clinical and real-world evidence demonstrating our technology’s superior performance

The MiniMed 780G system has a strong base of clinical evidence, supported by over 200 clinical publications, eight randomized controlled trials, and nine health economic analyses, as of October 2025. In addition, there is a significant base of real-world data and experience as well from users, as hundreds of thousands of people have used our products. Broadly, this evidence supports the superiority of our system against other existing treatment options. Over the years, our products have produced consistent high-quality results for users.

Industry-defining innovation track record, skilled global R&D team, and robust proprietary Virtual Patient Model

We have a 40+ year history of demonstrated excellence in innovation. We are committed to making material contributions to improving the lives of PWD through industry-defining inventions, including the first insulin pump with mass-market appeal and usability, the first physician-use CGM system, and the first hybrid closed-loop pump system. We support our innovation mission with a strong base of scientific, engineering, and regulatory expertise. Leading our efforts are over 1,100 research and development professionals who bring a diversity of skills across electrochemistry, electronics, mechanical engineering, software, data science and AI, and consumer electronics and valuable experience in the diabetes space. We have continuously invested in these capabilities and our innovation, deploying $236 million in research and development over the six months ended October 24, 2025 and $1.3 billion over the last three fiscal years.

Over the years, we have accumulated a wealth of longitudinal patient data and experience to support our continued innovation as the only company that has developed and commercialized both insulin delivery systems and CGM systems. Leveraging this proprietary data, we have constructed a robust Virtual Patient Model comprised of over 430 million datapoints from a wide variety of patients that simulates real-world conditions across a range of physiologies. With this Virtual Patient Model, we can accelerate our ability to iterate and virtually evaluate algorithm improvements with high correlation to real-world and controlled clinical outcomes. We believe it is a critical differentiator versus our competition, as dosing algorithms become more complicated and precise—eventually creating a completely hands-free experience, eliminating elements of user input such as carb counting.

Large intellectual property portfolio, fortifying our competitive positioning

Over our decades in operation, we have accumulated a large body of intellectual property. We vigorously safeguard our proprietary rights through a combination of patents, copyrights, trade secrets, nondisclosure agreements, and other legal protections. As of October 2025, we own or have rights to a large global patent portfolio with over 2,500 patents and patent applications worldwide, certain of which relate to various current or prospective aspects of the MiniMed 780G, Simplera CGM, InPen, algorithms, and adjunct products and systems. Protecting our intellectual property is a core strategic focus for our business, as we believe many of our current technologies and those in our pipeline are superior advancements to other products that are available today.

Attractive financial profile characterized by strong net sales growth, high device content per customer, and durable revenue base

Our competitive strengths and execution of our strategy has resulted in an attractive financial profile for our business. We have demonstrated double-digit year-over-year net sales growth in the last two fiscal years, driven by growing sales of our MiniMed 780G system as well as the successful launch of our Simplera CGM in the EU and the United States and Simplera Sync in the EU. Being the only player in the market that commercializes all parts of an integrated diabetes management system allows us to have the opportunity to generate greater revenue per customer compared to competitors that only offer components of such systems and positions us to grow and take share through commercial execution, particularly with our next generation of products.

Our offerings are designed to generate a significant amount of revenue per pump user. We have a robust global base of more than 640,000 pump users as of October 2025. To this user base, we sell compatible consumable products, including CGMs, infusion sets, reservoirs, and other software and services. In the six months ended October 24, 2025 and in fiscal year 2025, 83% and 80%, respectively, of our total revenue came from the sales of CGMs, other consumables, software, and services, which we believe make our core revenue base durable and resilient.

Highly experienced management team with a purpose-driven workforce—driving performance with a culture of accountability

Our global organization is led by an experienced, proven, and performance-driven senior management team that manages all aspects of our business. Our senior management team consists of industry and corporate veterans with a track record of leadership both within Medtronic and in other select world-class organizations. This team has a

passionate focus on helping PWD, and has been responsible for key recent organizational achievements that put our business on its current trajectory, including the 2023 U.S. FDA approval of our MiniMed 780G system, 2024 CE Mark and 2025 U.S. FDA approval for MiniMed 780G with Simplera Sync sensor, 2024 U.S. FDA approval of our Simplera CGM, and our global sensor partnership with Abbott announced in 2024.

Our Growth Strategies

We aim to generate sustainable and profitable growth through execution of our corporate strategies.

Serve unmet needs with our current AID system generation of solutions by executing our commercial strategy and expanding clinical indications

We also have an opportunity to grow the addressable market for MiniMed 780G through expanded indication labeling. For example, in fiscal year 2026, we received U.S. FDA and CE Mark approval for use of the MiniMed 780G system by insulin-requiring T2D patients. We believe the insulin-requiring T2D population is vastly underpenetrated around the world and well-suited for the MiniMed 780G system.

Leverage algorithm and dosing expertise to drive adoption of our current Smart MDI system generation

In addition to AID, we continue to drive momentum in our Smart MDI system solution. Our dosing algorithm technology and connected Smart MDI solutions help people with T1D or T2D to optimize their daily injections, driving better glycemic control versus other traditional therapy options. Our current-generation InPen with Simplera CGM and algorithm support has been proven to decrease severe hypoglycemic events by 13% in the 90 days after initiating InPen treatment, and by more than 30% among users aged 65 and over. Real-world evidence from a retrospective study of over 1,500 InPen users with T1D across 21 countries further supports the clinical benefits of the InPen system when used as directed. In this study, quicker responses to these alerts were associated with higher TIR. Responding within one hour to over 75% of missed dose alerts or correct high glucose results resulted in a mean TIR of 67.2% and 71.5%, respectively, without an increase in time-below-range (TBR). In summary, almost a quarter of the population of InPen users who consistently responded quickly to the actionable alerts met the established glycemic targets of >70% TIR and <7% GMI.

As we pursue our strategy to drive Smart Dosing adoption for people with T2D, our Smart MDI is an available, attractive option for those requiring basal insulin treatment. As with our AID strategy, we plan to continue to drive uptake through our dedicated commercial functions across our markets.

Expand CGM options for PWD with global Abbott CGM partnership

In addition to our Simplera and Simplera Sync, we are introducing an additional complementary CGM option through our global partnership with Abbott. Abbott will supply us with Instinct, an alternative CGM sensor based on Abbott’s most advanced single-analyte CGM technology, and will be the exclusive supplier of third-party CGMs for certain of our AID and Smart MDI systems. We believe our partnership with Abbott will allow us to expand access to our advanced AID and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM technology in the world.

Deliver breakthrough innovation with our pipeline including our next-generation AID and Smart MDI solutions

We believe our pipeline is at a critical turning point where our next-generation AID system will create significant competitive differentiation to fulfill our mission of safely and effectively automating diabetes management to deliver a “hands-off” patient experience. We plan for this system to provide our customers with much greater choice for AID treatment using new technologies across insulin administration, CGM, and dosing algorithm technologies, in one unified platform and one consistent application for user and HCP experience, all while further reducing patient burdens significantly and raising the bar for clinical outcomes.

Our rich pipeline includes the MiniMed Go, our next-generation Smart MDI system; the MiniMed Flex, our smaller, screenless, newly designed insulin pump; our next-generation Vivera dosing algorithm; and our MiniMed Fit patch pump with extended wear. In addition, we are working to progress Instinct in our global partnership with Abbott. These low-burden, easy-to-use, and consumer-friendly products are expected to be wrapped around a unique software system that we are designing to allow the user to switch easily between devices to customize their treatment with a desired system solution combining these technologies.

Accelerate growth through strategic partnerships and tuck-in acquisition opportunities

As an independent company, we expect to have independent financial flexibility, scale, and access to capital markets that we may utilize to complement our organic initiatives with additional inorganic opportunities when appropriate. We have identified an attractive set of strategic opportunities across potential partnerships and tuck-in acquisitions. As part of this strategy, we expect to continue to pursue attractive strategic collaboration opportunities, such as our announced partnership with Abbott to expand CGM choice and access to our AID and Smart MDI solutions. In addition, we expect to be opportunistic in pursuing growth-enhancing partnerships and/or tuck-in acquisitions.

Drive profit margin expansion by capitalizing on the utilization of our fully integrated diabetes systems

Our aim is to grow our profit and cash flow at a higher rate than our revenues through a number of levers. We first plan to drive sales of our full-system solution to optimize our opportunity to generate greater revenue per customer, compared to competitors that only offer components of such systems, which we believe will translate to higher margins as we sell higher volumes of product. As our CGM sensors, insulin pumps, and Smart MDI solutions continue to proliferate, we also have an opportunity to expand our margins by developing and building out new high-volume and automated manufacturing. In particular, we believe our process for manufacturing our sensors has potential for significant expansion at higher volumes. We are currently working to develop and implement high-volume and automated machine manufacturing lines to expand manufacturing capacity. While executing on these opportunities, we also plan to continue to execute our regular cadence of cost transformation initiatives, which have resulted in cost savings in recent periods.

The Separation and Post-Separation Relationship with Medtronic

On May 21, 2025, Medtronic, our parent company, announced its intention to separate its Diabetes Operating Unit (the “Separation”). In connection with the Separation and prior to the completion of this offering, Kangaroo US HoldCo 2, Inc. (“KHC2”), which is currently an indirect wholly-owned subsidiary of Medtronic, will enter into a separation agreement with Medtronic. We refer to the separation agreement, as further described in the section of this prospectus entitled “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Separation Agreement,” as the “Separation Agreement.” KHC2 will also enter into various other agreements with Medtronic that, together with the Separation Agreement, provide for certain transactions to effect the transfer of the assets and liabilities of the Diabetes Operating Unit to us and will result in the separation of the diabetes business from Medtronic. Prior to the completion of this offering, KHC2 will merge with and into MiniMed Group, Inc. (the “Merger”), with MiniMed Group, Inc. surviving the Merger and continuing as the counterparty to the agreements with Medtronic described below. In addition, these agreements will collectively govern various interim and ongoing relationships between us and Medtronic following the completion of this offering. We refer to these transactions, as further described in the section of this prospectus entitled “The

Separation and Divestment Transactions—The Separation,” collectively as the “Separation.” See “The Separation and Divestment Transactions—The Separation.”

The agreements we will enter into with Medtronic in connection with the Separation, which will provide a framework for our relationship with Medtronic following the Separation, include the following:

•Separation Agreement – We and Medtronic will enter into a separation agreement that will set forth our agreements with Medtronic regarding the principal actions to be taken in connection with the Separation and govern, among other matters, (1) the allocation of assets and liabilities to us and Medtronic (including our indemnification obligations, for potentially uncapped amounts, for certain liabilities relating to our business activities, whether incurred prior to or following the completion of this offering) and (2) certain matters with respect to this offering and the Divestment (as defined below).

•Tax Matters Agreement – We and Medtronic will enter into a tax matters agreement that will govern our and Medtronic’s respective rights, responsibilities, and obligations with respect to tax matters, including tax liabilities (including responsibility and potential indemnification obligations for taxes attributable to our business and taxes arising, under certain circumstances, in connection with the Separation and the Divestment, if pursued), tax attributes, tax contests, and tax returns. In addition, the tax matters agreement will impose certain restrictions on us and our subsidiaries (including, among others, restrictions on share issuances, business combinations, sales of assets, and similar transactions) intended to preserve the tax-free status of various transactions related to the Separation and the Divestment.

•Employee Matters Agreement – We and Medtronic will enter into an employee matters agreement that will address certain employment, compensation, and benefits matters, including the allocation and treatment of certain assets and liabilities relating to our employees, the treatment of outstanding Medtronic equity awards held by our employees, and compensation and benefit plans and programs in which our employees participate.

•Intellectual Property Cross-License Agreements – We and Medtronic will enter into two intellectual property cross-license agreements intended to provide the companies freedom to operate in their respective businesses.

•Trademark Agreements – We and Medtronic will enter into various trademark agreements that collectively govern our and Medtronic’s respective rights, responsibilities, and obligations with respect to intellectual property rights in trademarks.

•Transition Services Agreement – We and Medtronic will enter into a transition services agreement, pursuant to which Medtronic will provide to us and we will provide to Medtronic certain services for a limited period of time following the completion of this offering.

•Juncos Lease and Services Agreements – We and Medtronic will enter into a lease agreement and a services agreement pursuant to which we will provide a long-term lease to Medtronic for a portion of our Juncos, Puerto Rico facility.

•Transition Manufacturing and Supply Agreement – We and Medtronic will enter into a transition manufacturing and supply agreement in connection with the Separation pursuant to which Medtronic and its affiliates will provide us, on a transitional basis, with certain manufacturing and assembly services with respect to certain products.

See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation” for a more detailed discussion of these agreements.

All of the agreements relating to the Separation will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of our separation from Medtronic. The terms of these agreements, including the costs of any services provided, may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See “Risk Factors—Risks Related to the Separation and the Divestment—The terms

we will receive in our transaction agreements with Medtronic could be less beneficial than the terms we may have otherwise received from unaffiliated third parties.”

We believe, and Medtronic has advised us that it believes, that the Separation, this offering, and the Divestment, if pursued, will provide a number of benefits to our business. These intended benefits include:

•improving our strategic and operational flexibility;

•increasing the focus of our management team on our business operations;

•allowing us to adopt the capital structure, investment policy, and dividend policy best suited to our financial profile and business needs; and

•enabling potential investors to invest directly in our business.

However, we cannot assure you that we will be able to achieve these and other anticipated benefits of the Separation, and the benefits of the Separation may be delayed or not occur at all. See “Risk Factors—Risks Related to the Separation and the Divestment—We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, results of operations, financial condition, and cash flows.”

The Divestment

Upon completion of this offering, Medtronic will continue to own at least 80.1% of the voting power of our shares of common stock eligible to vote in the election of our directors. Medtronic has informed us that, following the completion of this offering, it intends to make a generally tax-free distribution to its shareholders of all or a portion of its remaining equity interest in us, which may be structured as a spin-off, in which Medtronic would make a pro rata distribution of our common stock to all Medtronic shareholders, a split-off, in which Medtronic would effect an exchange of Medtronic shares for shares of our common stock, or any combination thereof. We refer to these options, as further described in the section of this prospectus entitled “The Separation and Divestment Transactions—The Divestment,” collectively as the “Divestment.”

Medtronic has agreed not to effect the Divestment for a period of 180 days after the date of this prospectus without the prior written consent of each of Goldman Sachs & Co. LLC and BofA Securities, Inc. See “Underwriting.” While, as of the date of this prospectus, Medtronic intends to effect the Divestment, Medtronic has no obligation to pursue or consummate any further dispositions of its equity interest in the Company, including through the Divestment, by any specified date or at all. If pursued, the Divestment may be subject to a number of conditions, including the receipt of any necessary regulatory or other approvals, the existence of satisfactory market conditions, and tax opinions from its U.S. tax advisors (the “Tax Opinions”) substantially to the effect that, among other things, the Divestment will qualify as a transaction that is generally tax-free for U.S. federal income tax purposes under Section 355 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”). The conditions to the Divestment may not be satisfied, Medtronic may decide not to consummate the Divestment even if the conditions are satisfied, or Medtronic may decide to waive one or more of the conditions and consummate the Divestment even if all of the conditions are not satisfied. See “The Separation and Divestment Transactions—The Divestment.”

Upon completion of the Divestment, if pursued, we will no longer qualify as a “controlled company” as defined under the corporate governance rules of Nasdaq, and, to the extent we have not done so already, we will be required to fully implement the corporate governance requirements of Nasdaq within the transition periods specified in the rules of Nasdaq. See “Management—Controlled Company Exemption.”

Revolving Credit Facility

In connection with the Separation, we have entered into a revolving credit facility. See “Description of Certain Indebtedness.”

Recent Developments

Preliminary Estimated Operating Results for the Three and Nine Months Ended January 23, 2026

Set forth below are preliminary unaudited estimates of certain financial information for the three and nine months ended January 23, 2026, and actual unaudited financial information for the three and nine months ended January 24, 2025. We have not yet finalized our financial information for the three and nine months ended January 23, 2026, and therefore the preliminary unaudited estimates of certain financial information for the three and nine months ended January 23, 2026 presented herein reflect preliminary estimates based on currently available information and are subject to completion of our financial closing procedures, which we do not expect to complete for the three and nine months ended January 23, 2026 until after the completion of this offering. As a result, our actual results will not be available to you prior to investing in this offering and may vary from the preliminary estimates presented herein. You should also note that additional information on results presented herein will be included in future reports expected to be available only after this offering, such as complete financial results for the three and nine months ended January 23, 2026 and January 24, 2025, and footnote disclosures associated with our financial results. If our complete financial results for the three and nine months ended January 23, 2026 and January 24, 2025, become available prior to the effective date of this registration statement, our registration statement will be amended to include these results.

The preliminary unaudited estimates of certain financial information have been presented as a range with low-end and high-end estimates which were prepared based on information available to us as of the date of this prospectus. We are providing ranges, rather than specific amounts, as our financial closing procedures for the three and nine months ended January 23, 2026 are not yet complete and actual results may vary from the preliminary unaudited estimates. The ranges were determined on preliminary unaudited estimates of certain financial information based on reasonable assumptions and management’s reasonable judgment. Our actual results may vary. Factors that could cause the actual results to differ include (but are not limited to) completion of our financial closing and reporting procedures, the discovery of new information that affects accounting estimates and management’s judgments, and adjustments that may be made through our financial statement close process. Further, these preliminary unaudited estimates of certain financial information may not be indicative of the results for any future period as a result of various factors, including, but not limited to, those discussed in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.”

Our low-end and high-end estimates of net loss reflect pre-tax charges of $118 million in relation to management’s approval of a plan to terminate a third-party manufacturing agreement in December 2025. Refer to Note 16, “Subsequent Events” to the unaudited condensed combined financial statements included elsewhere in this prospectus for further information.

The preliminary unaudited estimates of certain financial information presented below have been prepared by, and are the responsibility of, management. PricewaterhouseCoopers LLP (“PwC”), our independent registered public accounting firm, has not audited, reviewed, examined, compiled, or applied agreed-upon procedures with respect to the preliminary unaudited estimates of certain financial information. Accordingly, PwC does not express an opinion or any other form of assurance with respect thereto.

The following table sets forth our key business metrics, including non-GAAP measures, for the periods indicated:


	Three months ended
	January 23, 2026			January 23, 2026			January 24, 2025
(Dollars in millions)	Low Estimate			High Estimate			Actual
Net Sales	$	790		$	790		$	687
Gross Profit	$	344		$	380		$	395
Net Loss	$	(106)		$	(117)		$	(7)
New Pumps Sold	38,971			38,971			36,894
Global CGM Attachment Rate	67		%	67		%	61		%
Net Sales Growth	15.0		%	15.0		%	N/A
Organic Revenue Growth (1)	8.6		%	8.6		%	N/A
Adjusted Gross Profit (2)	$	434		$	480		$	401


	Nine months ended
	January 23, 2026			January 23, 2026			January 24, 2025
(Dollars in millions)	Low Estimate			High Estimate			Actual
Net Sales	$	2,265		$	2,265		$	1,991
Gross Profit	$	1,140		$	1,260		$	1,123
Net Loss	$	(126)		$	(139)		$	(30)
New Pumps Sold	103,008			103,008			102,342
Global CGM Attachment Rate	66		%	66		%	59		%
Net Sales Growth	13.7		%	13.7		%	N/A
Organic Revenue Growth (1)	7.8		%	7.8		%	N/A
Adjusted Gross Profit (2)	$	1,235		$	1,366		$	1,162

________________

(1)Organic Revenue Growth measures our revenue growth trends excluding the impacts of foreign currency rate fluctuations and adjustments to the Company’s Italian payback accrual for certain years since 2015. For additional information about our non-GAAP measures, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Financial Measures.”

(2)We define Adjusted Gross Profit as U.S. GAAP gross profit, excluding amortization of intangible assets and certain non-operational items. For additional information about our non-GAAP measures, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Financial Measures.”

Net Sales

The table below includes our net sales by product category for the three months ended January 23, 2026 and January 24, 2025:


	Three months ended
	January 23, 2026		January 24, 2025		Change
(Dollars in millions)	Estimated		Actual		Amount		Percent
Pumps	$	151	$	136	$	15	10.8	%
Consumables	244		213		31		14.6
CGM	390		330		61		18.4
Other (1)	5		8		(3)		(37.7)
Total	$	790	$	687	$	103	15.0	%

__________________

(1)Primarily includes net sales generated from the sale of smart insulin pens and services.

The table below includes net sales by market geography for the three months ended January 23, 2026 and January 24, 2025:


	Three months ended
	January 23, 2026		January 24, 2025		Change
(Dollars in millions)	Estimated		Actual		Amount		Percent
U.S. (1)	$	242	$	231	$	11	4.7	%
International (2)	548		456		92		20.3
Total	$	790	$	687	$	103	15.0	%

__________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

Net sales for the three months ended January 23, 2026 is expected to be $790 million as compared to $687 million for the three months ended January 24, 2025, growing 20% internationally and 5% in the United States. The expected net sales growth is the result of increased volumes. The expected international net sales growth is the result of 12% growth in pumps, 20% growth in consumables, 26% growth in CGM and favorable foreign currency exchange fluctuations. The expected sales performance in the United States is the result of 8% growth in pumps, a 1% decline in consumables, and 6% growth in CGM.

Pump sales are expected to grow 10.8% for the three months ended January 23, 2026. We experienced continued growth of 12% in international pump sales since the launch of the Simplera CGM in Europe in fiscal year 2025. Following the launch of Simplera and Instinct CGM in the United States in the third quarter of fiscal year 2026, domestic pump sales returned to growth and are expected to increase 8% for the three months ended January 23, 2026, as compared to the three months ended January 24, 2025.

Consumables sales are expected to increase 14.6% for the three months ended January 23, 2026, resulting from expected 20% growth internationally. Our expected international growth is the result of increased volume of patients using our AID systems which require frequent replacement of the infusion sets and reservoirs for uninterrupted operation. The increase in the volume of patients using our AID systems in international markets is due to the competitive strength of the MiniMed 780G system which has enabled us to attract new patients as well as retain our existing patient base.

CGM sales are expected to increase 18.4% for the three months ended January 23, 2026, as a result of continued increase in the CGM Attachment Rate, which rose from 61% in the three months ended January 24, 2025, to 67% in the three months ended January 23, 2026. Higher CGM Attachment Rate and pump user base in international markets is expected to result in 26% growth in international CGM sales which is primarily attributable to the introduction of the Simplera CGM in Europe in fiscal year 2025. The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs. The discreet design simplifies the insertion and wear experience. U.S. CGM sales is expected to grow 6% during the three months ended January 23, 2026, as a result of a sustained upward trend in CGM Attachment Rate. We have experienced a sustained upward trend in CGM Attachment Rate in the United States since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.

The table below includes our net sales by product category for the nine months ended January 23, 2026 and January 24, 2025:


	Nine months ended
	January 23, 2026		January 24, 2025		Change
(Dollars in millions)	Estimated		Actual		Amount		Percent
Pumps	$	401	$	387	$	14	3.6	%
Consumables	707		632		75		11.9
CGM	1,133		968		165		17.0
Other (1)	24		4		20		NM (2)
Total	$	2,265	$	1,991	$	274	13.7	%

__________________

(1)Primarily includes net sales generated from the sale of smart insulin pens and services. Also reflects adjustments to the Company’s Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015. Refer to Note 13, “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus for further information.

(2)Not meaningful

The table below presents our net sales by market geography for the nine months ended January 23, 2026 and January 24, 2025:


	Nine months ended
	January 23, 2026		January 24, 2025		Change
(Dollars in millions)	Estimated		Actual		Amount		Percent
U.S. (1)	$	679	$	668	$	10	1.5	%
International (2)	1,586		1,323		263		19.9
Total	$	2,265	$	1,991	$	274	13.7	%

__________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

We expect net sales for the nine months ended January 23, 2026 to be $2,265 million as compared to $1,991 million for the nine months ended January 24, 2025, growing 19.9% internationally and 1.5% in the United States. The expected net sales growth is primarily the result of increased volumes. The expected international net sales growth is the result of 11% growth in pumps, 16% growth in consumables, 22% growth in CGM, changes in the Company’s Italian payback accrual, and favorable impacts of foreign currency fluctuations. The expected sales performance in the United States is the result of a 7% decline in pumps, a 1% decline in consumables, and 7% growth in CGM. For the nine months ended January 23, 2026, the impact of the Italian payback adjustment resulted in an increase to net sales of $7 million as compared to a decrease in net sales of $20 million for the nine months ended January 24, 2025 due to changes in estimates relating to our Italian payback accrual resulting from the two July 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government in June 2025 and formalized into law in August 2025 for certain prior years since 2015.

Pump sales are expected to grow 3.6% for the nine-months ended January 23, 2026. While we experienced continued growth of 11% in international pump sales following the launch of the Simplera CGM in Europe in fiscal year 2025, we experienced a 7% decline in the United States due to the delayed launch of Simplera CGM and increased competition. The delayed launch of Simplera CGM in the United States resulted in a competitive disadvantage and limited our ability to grow NPS in the first half of fiscal year 2026. However, following the launch of Simplera and Instinct CGM in the United States in the third quarter of fiscal year 2026, domestic pump sales returned to growth, reducing year-to-date pump sales decline to 7% for the nine months ended January 23, 2026 versus a 15% decline for the six months ended October 24, 2025.

Consumables sales are expected to increase 11.9% for the nine months ended January 23, 2026, as a result of 16% growth internationally and 1% decline in the United States. Our expected international growth is the result of increased volume of patients using our AID systems which require frequent replacement of the infusion sets and

reservoirs for uninterrupted operation. The increase in the volume of patients using our AID systems in international markets is due to the competitive strength of the MiniMed 780G system which has enabled us to attract new patients as well as retain our existing patient base. Fewer NPS in the United States resulted in reduced consumables sales in the nine months ended January 23, 2026.

CGM sales are expected to increase 17.0% for the nine months ended January 23, 2026, as a result of the continued increase in the CGM Attachment Rate, which rose from 59% in the nine months ended January 24, 2025, to 66% in the nine months ended January 23, 2026. Higher CGM Attachment Rate and pump user base in international markets drove 22% growth in international CGM sales which is primarily attributable to the introduction of the Simplera CGM in Europe in fiscal year 2025. The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs. The discreet design simplifies the insertion and wear experience. CGM sales in the United States are expected to grow 7% as a result of a sustained upward trend in CGM Attachment Rate and the launch of Simplera and Instinct CGM in the third quarter of fiscal year 2026. We have experienced a sustained upward trend in CGM Attachment Rate in the United States since the launch of the MiniMed 780G system in fiscal year 2024 as the automation algorithm is only compatible with our MiniMed CGMs.

Organic Revenue Growth

The table below presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for the three months ended January 23, 2026, and January 24, 2025:


	Three months ended
	Reported net sales						Adjustments				Organic revenue
	Estimate		Actual				Estimate		Actual		Estimate		Actual
(Dollars in millions)	January 23, 2026		January 24, 2025		Growth		January 23, 2026 (3)		January 24, 2025		January 23, 2026 (3)		January 24, 2025		Growth
U.S. (1)	$	242	$	231	4.7	%	$	—	$	—	$	242	$	231	4.7	%
International (2)	548		456		20.3		44		—		504		456		10.5	%
Total	$	790	$	687	15.0	%	$	44	$	—	$	746	$	687	8.6	%

________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

(3)The three months ended January 23, 2026 excludes $44 million of revenue adjustments related to favorable currency impact on net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.

The table below presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for the nine months ended January 23, 2026, and January 24, 2025:


	Nine months ended
	Reported net sales						Adjustments				Organic revenue
	Estimate		Actual				Estimate		Actual		Estimate		Actual
(Dollars in millions)	January 23, 2026		January 24, 2025		Growth		January 23, 2026 (3)		January 24, 2025 (4)		January 23, 2026 (3)		January 24, 2025 (4)		Growth
U.S. (1)	$	679	$	668	1.5	%	$	—	$	—	$	679	$	668	1.5	%
International (2)	1,586		1,323		19.9		97		(20)		1,489		1,343		10.9	%
Total	$	2,265	$	1,991	13.7	%	$	97	$	(20)	$	2,168	$	2,012	7.8	%

________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

(3)The nine months ended January 23, 2026 excludes $97 million of revenue adjustments, including $7 million reduction in the Italian payback accruals due to changes in estimates as a result of the Legislative Decree published by the Italian government on June 30, 2025 for years 2015 to 2018 and $90 million of favorable currency impact on the remaining net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.

(4)The nine months ended January 24, 2025 excludes $20 million of revenue adjustments related to incremental Italian payback accruals as a result of the two July 22, 2024 rulings by the Constitutional Court of Italy for certain prior years since 2015.

Adjusted Gross Profit

The table below presents a reconciliation of U.S. GAAP gross profit to Adjusted Gross Profit for the three months ended January 23, 2026 and January 24, 2025:


	Three months ended
	January 23, 2026		January 23, 2026		January 24, 2025
(Dollars in millions)	Low estimate		High estimate		Actual
Gross profit	$	344	$	380	$	395
Adjustments:
Restructuring and associated costs (1)	85		94		—
Amortization of intangible assets	6		6		6


Adjusted Gross Profit (Non-GAAP)	$	434	$	480	$	401

________________

(1)Primarily relates to asset write-offs associated with the December 2025 plan to terminate a third-party manufacturing agreement.

The table below presents a reconciliation of U.S. GAAP gross profit to Adjusted Gross Profit for the nine months ended January 23, 2026 and January 24, 2025:


	Nine months ended
	January 23, 2026		January 23, 2026		January 24, 2025
(Dollars in millions)	Low estimate		High estimate		Actual
Gross profit	$	1,140	$	1,260	$	1,123
Adjustments:
Restructuring and associated costs (1)	85		94		—
Amortization of intangible assets	17		19		18
Other adjustments (2)	(7)		(7)		20
Costs to comply with medical device regulations (3)	—		—		1
Adjusted Gross Profit (Non-GAAP)	$	1,235	$	1,366	$	1,162

__________________

(1)Primarily relates to asset write-offs associated with the December 2025 plan to terminate a third-party manufacturing agreement.

(2)Reflects adjustments to the Company’s Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015.

(3)The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

Summary of Risk Factors

An investment in shares of our common stock is subject to a number of risks that may prevent us from achieving our business objectives or otherwise adversely affect our business, results of operations, financial condition, or cash flows. The following list contains a summary of some, but not all, of these risks. You should consider the risks listed below and other risks, which are discussed in more detail in the section of this prospectus entitled “Risk Factors,” before making an investment decision to purchase shares of our common stock.

Business and Operational Risks

•We operate in a highly competitive industry and we may be unable to compete effectively. Our success depends on our ability to differentiate our products and keep pace with emerging technologies.

•Competing products, therapeutic techniques, or other technological developments and breakthroughs for the monitoring, treatment, or prevention of diabetes may render our products obsolete or less desirable.

•We have experienced, and may continue to experience, pricing pressure for our products.

•We have in the past experienced, and may in the future experience, challenges or delays in the development and manufacturing of new products.

•We have experienced, and may continue to experience, a reduction or an interruption in supply or other manufacturing difficulties, including in connection with our Simplera CGMs and certain other products.

•We are subject to additional risks associated with our reliance on sole suppliers.

•Our products may not achieve or maintain market acceptance.

•We may fail to expand or maintain an effective sales force, predict and adapt to changes in markets, or develop and maintain relationships with HCPs or intermediaries to market and sell our products.

•Interim, “top-line,” and preliminary data from clinical trials that we announce or publish may change as more patient data become available or as a result of audit and verification procedures.

•Future market or clinical studies may be unfavorable to our products and their efficacy.

•We are subject to a variety of risks associated with global operations.

•We are subject to risks relating to coverage or reimbursement for our products.

•We undertake research and development efforts, make investments, and enter into arrangements with third parties that may not successfully develop viable products or generate future revenues.

•We may fail to integrate any acquired businesses into our operations successfully or may experience challenges related to our strategic initiatives, including divestitures and third-party funding arrangements.

Legal and Regulatory Risks

•We are subject to extensive, complex, and changing laws and governmental regulations, including U.S. and international tax laws and the Foreign Corrupt Practices Act (the “U.S. FCPA”) and similar international anti-corruption laws.

•We have been, and may in the future become, subject to, or involved in, adverse regulatory action, litigation, and arbitration, including those stemming from third-party conduct beyond our control.

•We have been and are subject to risks relating to quality problems and improper promotion of our products.

•We are substantially dependent on patent and other proprietary rights, and failing to protect such rights may negatively impact our ability to sell current or future products.

•We rely on the proper function, security, and availability of our information technology systems and data to operate our business and comply with privacy and data protection regulations.

•We are subject to environmental, health, and safety (“EHS”) laws and regulations that may increase costs, impact or limit business plans, or expose us to environmental liabilities, violations, and litigation.

Risks Related to the Separation and Divestment

•We have a limited history of operating as a standalone public company and will incur incremental costs as a result.

•We may not achieve some or all of the expected benefits of the Separation, the Separation could adversely affect our business, and we may have difficulty separating our assets or operations from Medtronic.

•Our rebranding strategy in connection with the Separation will involve substantial costs and may not produce the intended benefits.

•We will incur significant charges in connection with the Separation.

•We may face restrictions on our business, potential tax and indemnification liabilities, and substantial charges in connection with the Separation, the Divestment, and related transactions.

•We may face difficulty and incur incremental costs related to the hiring and retention of an appropriately qualified employee workforce.

Risks Related to Our Relationship with Medtronic

•We will be a “controlled company” as defined under the corporate governance rules of Nasdaq.

•Medtronic will continue to control the direction of our business, and the distribution of Medtronic’s remaining equity interest in us may not occur, or Medtronic may privately sell a sufficiently large equity interest in us to a third party that could result in a change of control of us.

•Medtronic may fail to perform under various transaction agreements that will be executed as part of the Separation, or we may fail to have replacement systems and services in place when certain of the transaction agreements expire.

•Certain of our executive officers and directors may have actual or potential conflicts of interest.

•We may have reached better terms from unaffiliated third parties than the terms we will receive in our agreements with Medtronic.

Risks Related to this Offering and Ownership of Our Common Stock

•We cannot be certain that an active trading market for our common stock will develop or be sustained following the completion of this offering.

•The price of our common stock may fluctuate significantly.

•The Divestment, if pursued, or future sales by Medtronic or other holders of shares of our common stock, or the perception that the Divestment or such sales may occur, including following the expiration of the lock-up period, could cause the price of our common stock to decline.

•We do not expect to pay dividends on our common stock for the foreseeable future.

As noted above, any of the foregoing risks could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Corporate Information

We were incorporated in Delaware on February 27, 2025 in connection with the Separation and were formed to ultimately hold, directly or indirectly, the Diabetes Operating Unit. We were incorporated with nominal capital and prior to the Separation have no material assets or liabilities and expect our operational activities to be limited to those required to execute the planned Separation. Prior to the completion of this offering, we are a wholly owned subsidiary of Medtronic and all of our outstanding shares of common stock are owned by Medtronic. Our principal executive offices are located at 18000 Devonshire St., Northridge, CA 91325, and our telephone number is (763) 514-4000. Our website address is www.minimed.com. The information contained on, or that can be accessed through, our website is not part of, and is not incorporated into, this prospectus, and you should not rely on any such information in making an investment decision to purchase shares of our common stock. We have included our website address only as an inactive textual reference and do not intend it to be an active link to our website.

THE OFFERING


Common stock offered by us in this offering			28,000,000 shares (or 32,200,000 shares if the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments).

Common stock to be outstanding upon completion of this offering			280,813,348 shares (or 285,013,348 shares if the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments).

Common stock to be held by Medtronic upon completion of this offering			252,813,348 shares.

Underwriters’ option to purchase additional shares of our common stock from us to cover over-allotments			We have granted the underwriters an option for a period of 30 days from the date of this prospectus to purchase up to 4,200,000 additional shares of our common stock from us at the initial public offering price less the underwriting discounts and commissions to cover over-allotments.

Use of proceeds			We estimate that the net proceeds to us from this offering will be approximately $712,320,000 based on an assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. As part of the Separation, we intend to (i) retain an amount of the net proceeds from this offering such that we will have approximately $350 million of cash on hand, which we will use for general corporate purposes, (ii) use the excess of the net proceeds from this offering over such retained amount to repay (or cause one or more of our subsidiaries to repay) intercompany debt owed to Medtronic under a note, and (iii) to the extent the net proceeds from this offering exceed the retained amount and the principal amount of such note, pay additional consideration to an affiliate of Medtronic for certain assets transferred to us in the Separation.

Dividend policy			We do not expect to pay dividends on our common stock for the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future, if any, will be used for the operation and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors (the “Board”) and will depend upon many factors, including our financial condition, earnings, capital requirements, debt service obligations, restrictive covenants in the agreements governing our indebtedness, general economic business conditions, industry practice, legal requirements, and other factors that the Board may deem relevant. See “Risk Factors—Risks Related to This Offering and Ownership of Our Common Stock—We do not expect to pay dividends on our common stock for the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.” and “Dividend Policy.”


Controlled company			Upon completion of this offering, Medtronic will own 90.03% of the voting power of our shares of common stock eligible to vote in the election of our directors (or 88.70% if the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments). As a result, we will be a “controlled company” as defined under the corporate governance rules of Nasdaq and, therefore, will qualify for exemptions from certain corporate governance requirements of Nasdaq. See “Management—Controlled Company Exemption.” We intend to avail ourselves of the “controlled company” exemption under the corporate governance rules of Nasdaq. Accordingly, we will not be required to have a majority of “independent directors” on our board of directors as defined under the rules of Nasdaq.

			As long as Medtronic beneficially owns a majority of the voting power of our outstanding shares of common stock, Medtronic will generally be able to control the outcome of matters submitted to our stockholders for approval, including the election of directors, without the approval of our other stockholders. See “Risk Factors—Risks Related to Our Relationship with Medtronic—Following the completion of this offering, Medtronic will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.”

Proposed listing and symbol			We intend to list our shares of common stock on Nasdaq under the symbol “MMED.”

Risk factors			You should read the section of this prospectus entitled “Risk Factors” beginning on page 45 for a discussion of factors you should consider carefully before making an investment decision to purchase shares of our common stock.

Unless otherwise indicated or the context otherwise requires, references to the number and percentage of shares of our common stock to be outstanding upon completion of this offering are based on 280,813,348 shares of our common stock outstanding upon completion of this offering.

Unless otherwise indicated, the information presented in this prospectus:

•gives effect to the transactions described under “The Separation and Divestment Transactions—The Separation”;

•gives effect to our amended and restated certificate of incorporation and our amended and restated bylaws, which will be in effect prior to the completion of this offering and forms of which will be filed as exhibits to the registration statement of which this prospectus forms a part;

•assumes an initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus;

•assumes no exercise of the underwriters’ option to purchase additional shares of our common stock from us to cover over-allotments;

•excludes an aggregate number of shares of our common stock equal to 15% of our outstanding shares of common stock upon completion of this offering that we expect to reserve for issuance under our proposed equity incentive plan and employee stock purchase plan; and

•excludes any shares of our common stock that may become issued pursuant to Medtronic equity awards that may be converted into equity awards with respect to shares of our common stock. See “Certain

Relationships and Related Person Transactions—Employee Matters Agreement—Equity Incentive Compensation.”

SUMMARY HISTORICAL AND UNAUDITED PRO FORMA COMBINED FINANCIAL DATA

The summary historical audited combined statement of operations data and combined statement of cash flows data for the fiscal years ended April 25, 2025, April 26, 2024, and April 28, 2023 and the summary historical combined balance sheet data as of April 25, 2025 and April 26, 2024 have been derived from our audited combined financial statements included elsewhere in this prospectus. The summary historical unaudited condensed combined statement of operations data and unaudited condensed combined statement of cash flows data for the six months ended October 24, 2025 and October 25, 2024 and the summary historical unaudited condensed combined balance sheet data as of October 24, 2025 have been derived from our unaudited condensed combined financial statements included elsewhere in this prospectus.

All revenues, costs, assets, and liabilities that are either legally attributable to or directly associated with our business activities are included in the combined financial statements herein. Also, the Company has historically functioned together with other businesses controlled by Medtronic. Accordingly, the Company relied on Medtronic’s corporate and other support functions for its business and certain corporate and shared expenses have been allocated, including, but not limited to, finance and accounting, legal, information technology, human resources, facilities, warehousing, distribution, logistics, marketing, insurance, employee benefits and incentives, restructuring and associated costs, and stock-based compensation. However, the allocations may not reflect the expenses the Company would have incurred if the Company had been a standalone company for the periods presented. All such amounts have been deemed to have been incurred and settled by the Company in the period in which the costs were recorded and are included in Net investment from Parent. All of these expenses have been allocated on a basis considered reasonable by management, using either specific identification when identifiable, or proportional allocations determined on the basis of revenue, usage, headcount, or other measures. Management considers the basis on which these expenses have been allocated to be a reasonable reflection of the utilization of such services by the Company.

The historical combined financial data below is only a summary and should be read in conjunction with the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as our combined financial statements included elsewhere in this prospectus. The historical combined financial data may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during the periods presented, including changes that will occur in our operations and capital structure as a result of this offering and the Separation. In addition, the historical combined financial data may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future.

The summary unaudited pro forma condensed combined balance sheet data at October 24, 2025 and statement of operations data for the six months ended October 24, 2025 and for the fiscal year ended April 25, 2025 have been derived from our unaudited pro forma condensed combined financial statements included in the section of this prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Statements.” The unaudited pro forma condensed combined financial statements have been derived from our historical unaudited condensed combined statement of loss for the six months ended October 24, 2025, our historical audited combined statement of loss for the fiscal year ended April 25, 2025, and our historical unaudited condensed combined balance sheet at October 24, 2025. The pro forma adjustments to the unaudited pro forma condensed combined statement of operations for the six months ended October 24, 2025 and for the fiscal year ended April 25, 2025 assume that the Separation and related transactions occurred as of April 27, 2024, which was the first day of the 2025 fiscal year. The unaudited pro forma condensed combined balance sheet data gives effect to the Separation, the initial public offering, and related transactions as if they had occurred on October 24, 2025, our latest balance sheet date. See “Unaudited Pro Forma Condensed Combined Financial Statements.”

The unaudited pro forma condensed combined financial data below is only a summary and should be read in conjunction with the section of this prospectus entitled “Unaudited Pro Forma Condensed Combined Financial Statements.” The unaudited pro forma condensed combined financial data is based upon available information and assumptions that we believe are reasonable and supportable. The summary unaudited pro forma condensed combined financial data is for illustrative and informational purposes only. The summary unaudited pro forma condensed combined financial data may not necessarily reflect what our financial condition, results of operations, or

cash flows would have been had we been a standalone company during the periods presented. In addition, the summary unaudited pro forma condensed combined financial data may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future.

Amounts reported in millions within the tables below are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in millions due to rounding. Additionally, certain columns and rows within tables may not sum due to rounding.

Combined Statement of Operations Data


	Pro Forma		Historical
	Six months ended		Six months ended
(Dollars in Millions)	October 24, 2025		October 24, 2025		October 25, 2024
Net sales	$	1,475	$	1,475	$	1,304
Cost of products sold	638		637		577
Gross profit	837		838		728
Research and development expense	236		236		217
Selling, general, and administrative expenses	601		575		536
Certain litigation charges	17		17		—
Other operating expense (income), net	7		7		(5)
Operating profit (loss)	(24)		3		(20)
Other non-operating expense, net	1		1		—
Profit (loss) before income taxes	(25)		2		(20)
Income tax provision	22		23		3
Net loss	(46)		(21)		(23)
Net income attributable to noncontrolling interests	—		(8)		(8)
Net loss attributable to Diabetes Business	$	(46)	$	(29)	$	(31)


	Pro Forma		Historical
	Fiscal year		Fiscal year
(Dollars in Millions)	2025		2025		2024		2023
Net sales	$	2,715	$	2,715	$	2,469	$	2,245
Cost of products sold	1,190		1,187		1,032		937
Gross profit	1,525		1,528		1,436		1,308
Research and development expense	438		436		437		429
Selling, general, and administrative expenses	1,131		1,080		1,057		960
Certain litigation charges	165		165		—		—
Other operating (income) expense, net	(8)		(8)		11		(12)
Operating loss	(202)		(146)		(69)		(69)
Other non-operating expense, net	1		1		1		7
Loss before income taxes	(203)		(147)		(70)		(76)
Income tax provision	48		52		38		16
Net loss	(250)		(198)		(107)		(92)
Net income attributable to noncontrolling interests	—		(15)		(5)		(5)
Net loss attributable to Diabetes Business	$	(250)	$	(213)	$	(112)	$	(96)

Combined Balance Sheet Data


	Pro Forma		Historical
	As of		As of
(Dollars in Millions)	October 24, 2025		October 24, 2025		April 25, 2025		April 26, 2024
Total assets	$	4,235	$	4,289	$	4,201	$	4,094
Total liabilities	490		729		871		647
Total equity (1)	3,745		3,560		3,330		3,448

__________________

(1)Total equity in the Historical column represents Total parent company equity as seen in the combined balance sheets.

Combined Statement of Cash Flows Data


	Historical
	Six months ended				Fiscal Year
(Dollars in Millions)	October 24, 2025		October 25, 2024		2025		2024		2023
Net cash flows (used in) provided by operating activities	$	(93)	$	33	$	140	$	41	$	(6)
Net cash used in investing activities	(124)		(86)		(193)		(157)		(180)
Net cash provided by financing activities	215		10		10		112		185

Other Data (Non-GAAP) (1)


	Historical
	Six months ended					Fiscal Year
(Dollars in Millions)	October 24, 2025			October 25, 2024		2025			2024			2023
Organic Revenue Growth	7.4		%	n/a		11.5		%	8.6		%	n/a
Adjusted Gross Profit	$	843		$	761	$	1,573		$	1,463		$	1,341
Adjusted EBITDA	128			97		253			147			136

__________________

(1)Organic Revenue Growth, Adjusted Gross Profit, and Adjusted EBITDA are non-GAAP financial measures. Management believes that these non-GAAP measures, together with the U.S. GAAP measures used by management, reflect how we measure our business internally and set operational goals and incentives. These non-GAAP measures should be considered supplements to, not substitutes for, or superior to, the corresponding measures calculated in accordance with U.S. GAAP. For additional information about these non-GAAP measures, including a reconciliation of each of these non-GAAP measures to its most directly comparable financial measure calculated in accordance with U.S. GAAP, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Measures.”

The following table presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for the six months ended October 24, 2025.


	Six months ended
	Reported net sales						Adjustments				Organic revenue
(Dollars in millions)	October 24, 2025		October 25, 2024		Growth		October 24, 2025 (3)		October 25, 2024 (4)		October 24, 2025 (3)		October 25, 2024 (4)		Growth
U.S. (1)	$	437	$	437	(0.1)	%	$	—	$	—	$	437	$	437	(0.1)	%
International (2)	1,038		867		19.7		52		(20)		986		887		11.1
Total	$	1,475	$	1,304	13.1	%	$	52	$	(20)	$	1,423	$	1,325	7.4	%

________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

(3)The six months ended October 24, 2025 excludes $52 million of revenue adjustments, including $7 million reduction in the Italian payback accruals due to changes in estimates as a result of the Legislative Decree published by the Italian government on June 30, 2025 for years 2015 to 2018 and $45 million of favorable currency impact on the remaining net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.

(4)The six months ended October 25, 2024 excludes $20 million of revenue adjustments related to incremental Italian payback accruals as a result of the two July 22, 2024 rulings by the Constitutional Court of Italy for certain prior years since 2015.

The following table presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for fiscal year 2025.


	Fiscal year
	Reported net sales						Adjustments				Organic revenue
(Dollars in millions)	2025		2024		Growth		2025 (3)		2024		2025 (3)		2024		Growth
U.S. (1)	$	903	$	833	8.4	%	$	—	$	—	$	903	$	833	8.4	%
International (2)	1,812		1,636		10.8		(39)		—		1,851		1,636		13.1
Total	$	2,715	$	2,469	10.0	%	$	(39)	$	—	$	2,754	$	2,469	11.5	%

________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

(3)Fiscal year 2025 excludes $39 million of revenue adjustments, including $20 million of incremental Italian payback accruals as a result of the two July 22, 2024 rulings by the Constitutional Court for certain prior years since 2015 and $19 million of unfavorable currency impact on the remaining net sales. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.

The following table presents a reconciliation of U.S. GAAP net sales to Organic Revenue Growth for fiscal year 2024.


	Fiscal year
	Reported net sales						Adjustments				Organic revenue
(Dollars in millions)	2024		2023		Growth		2024 (3)		2023		2024 (3)		2023		Growth
U.S. (1)	$	833	$	832	0.1	%	$	—	$	—	$	833	$	832	0.1	%
International (2)	1,636		1,413		15.8		31		—		1,605		1,413		13.6
Total	$	2,469	$	2,245	10.0	%	$	31	$	—	$	2,438	$	2,245	8.6	%

________________

(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

(3)Fiscal year 2024 excludes $31 million of revenue adjustments related to favorable currency impact. The currency impact to net sales measures the change in net sales between current and prior year periods using constant exchange rates.

The following table presents a reconciliation of the change in U.S. GAAP gross profit to Adjusted Gross Profit for the six months ended October 24, 2025 and October 25, 2024.


	Six months ended
(in millions)	October 24, 2025		October 25, 2024
Gross Profit	$	838	$	728
Adjustments:
Amortization of intangible assets	12		12
Other adjustments (1)	(7)		20

Costs to comply with medical device regulations (2)	—		1
Adjusted Gross Profit (non-GAAP)	$	843	$	761

__________________

(1)Reflects adjustments to the Company’s Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015.

(2)The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

The following table presents a reconciliation of the change in U.S. GAAP gross profit to Adjusted Gross Profit for fiscal years 2025, 2024, and 2023.


	Fiscal Year
(in millions)	2025		2024		2023
Gross Profit	$	1,528	$	1,436	$	1,308
Adjustments:
Amortization of intangible assets	24		24		24
Other adjustments (1)	20		—		—
Restructuring and associated costs (2)	—		1		8
Costs to comply with medical device regulations (3)	1		2		1
Adjusted Gross Profit (non-GAAP)	$	1,573	$	1,463	$	1,341

__________________

(1)Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(2)These charges primarily include salaries and wages for employees that are fully dedicated to restructuring programs as well as consulting expenses directly related to the restructuring efforts.

The following table presents a reconciliation of U.S. GAAP net loss to Adjusted EBITDA for the six months ended October 24, 2025 and October 25, 2024.


	Six months ended
(in millions)	October 24, 2025		October 25, 2024
Net loss	$	(21)	$	(23)
Provision for taxes	23		3
Depreciation and amortization	78		68
Adjustments:
Stock-based compensation	26		22
Certain litigation charges (1)	17		—
Restructuring and associated costs (2)	4		6
Other adjustments (3)	(7)		20
Transaction costs (4)	7		1
Losses on minority investments (5)	1		1
Costs to comply with medical device regulations (6)	—		1
Acquisition-related costs	—		(1)
Adjusted EBITDA	$	128	$	97

__________________

(1)These charges relate to the Diabetes Pump Retainer Ring litigation.

(2)The charges primarily relate to employee termination benefits and consulting expenses directly related to the restructuring efforts.

(3)Reflects adjustments to the Company’s Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy and the Legislative Decree published by the Italian government on June 30, 2025 for certain prior years since 2015.

(4)These charges represent costs incurred associated with the Separation.

(5)We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(6)The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs.

The following tables present a reconciliation of U.S. GAAP net loss to Adjusted EBITDA for fiscal years 2025, 2024, and 2023.


	Fiscal Year
(in millions)	2025		2024		2023
Net loss	$	(198)	$	(107)	$	(92)
Provision for taxes	52		38		16
Depreciation and amortization	143		129		115
Adjustments:
Stock-based compensation	41		38		35
Certain litigation charges (1)	165		—		—
Restructuring and associated costs (2)	25		29		52
Other adjustments (3)	20		—		—
Transaction costs (4)	3		—		—
Costs to comply with medical device regulations (5)	1		2		1
Losses on minority investments (6)	1		1		7
Acquisition-related costs (7)	—		17		2
Adjusted EBITDA	$	253	$	147	$	136

__________________

(1)These charges relate to a contractual dispute resolution under one of the Diabetes product funding arrangements.

(2)Associated costs primarily include salaries and wages for employees that are fully dedicated to restructuring programs as well as consulting expenses directly related to the restructuring efforts.

(3)Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(4)These charges represent costs incurred associated with the Separation.

(5)The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(6)We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(7)These charges primarily relate to losses on foreign currency forward contracts entered into in advance of a previously contemplated business combination.

MARKET AND INDUSTRY DATA

Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations, market position, market share, market opportunity, and market size, has been obtained from third-party sources, including industry publications and other reports, internal data sources, and management estimates, which we believe to be reliable and based on reasonable assumptions. These third-party sources include Diabetes Metabolism Research and Reviews; Diabetes, Obesity and Metabolism; dQ&A; the IDF; the Journal of the American Medical Association; the Journal of Clinical Endocrinology & Metabolism; the Journal of Diabetes Technology & Therapeutics; Managed Markets Insights and Technology (“MMIT”); the National Institute of Health (the “NIH”); Seagrove Partners; the New England Journal of Medicine; and the World Health Organization (the “WHO”).

Unless otherwise indicated, we have not commissioned any of the industry publications or other reports generated by third-party providers that we refer to in this prospectus. Our management estimates are derived from such third-party sources, other publicly available information, our knowledge of our industry, internal company research, surveys, information from our customers and third-party partners, trade and business organizations, and other contacts in the markets in which we operate and assumptions based on this information and knowledge.

Data regarding our industry and our market position and market share within our industry are inherently imprecise and are subject to significant business, economic, and competitive uncertainties beyond our control, but we believe they generally indicate market size, market position, and market share within our industry. In addition, assumptions and estimates of our and our industry’s future performance involve risks and uncertainties and are subject to change based on various factors, including those described in the section of this prospectus entitled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and us. See “Cautionary Note Regarding Forward-Looking Statements.”

Certain of our products that are named in this prospectus are regulated by the U.S. FDA. For additional information about the regulation of these products, see “Business—Government Regulation and Product Approval Process—United States Regulations.”

In certain portions of this prospectus we reference meta-analyses when direct head-to-head studies are unavailable. We believe meta-analyses and comparisons of published real-world data are robust and valid ways to compare the glycemic outcomes of our devices with those of third-party devices. Peer-reviewed meta-analyses with broad acceptance criteria and analyses like random-effects frequentist network meta-analyses provide results with confidence intervals and offer robust statistical conclusions supporting comparison of devices using available clinical trial data. Further, large bodies of real-world evidence offer a strong means of mitigating these biases and normalizing many of the specific clinical and demographic variables that exist in the real-world use of AID systems.

The data presented in this prospectus are sourced from the following sources. Sources marked with a * were funded by Medtronic; sources marked with a ^ were authored or co-authored by Medtronic employees:

•Abraham MB et al., “Glycemic and Psychosocial Outcomes of Advanced Hybrid Closed-Loop Therapy in Youth With High HbA1c: A Randomized Clinical Trial,” Diabetes Care (2025), 48(1), 67-75.*

•Bandeiras C et al., “Bringing Stem Cell-Based Therapies for Type 1 Diabetes to the Clinic: Early Insights from Bioprocess Economics and Cost-Effectiveness Analysis,” Biotechnol J. (2019), 14(8), e1800563.

•Bergenstal RM et al., “A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.” Lancet (2021), 397(10270), 208-219.

•Bhargava A et al., “Safety and Effectiveness of MiniMedTM 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes,” Diabetes Technol Ther (2025), 27(5), 366-375.^

•Boucsein A et al., “Impact of Advanced Hybrid Closed Loop on Youth With High-Risk Type 1 Diabetes Using Multiple Daily Injections” Diabetes Care (2023), 46(3), 628-632.

•Castañeda J et al., “Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System,” Diabetes Care (2024), 47(5), 790-797.

•Choudhary P et al., “Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study,” Lancet Diabetes Endocrinol (2022), 10(10), 720-731.*^

•Choudhary P et al., “Celebrating the Data from 100,000 Real-World Users of the MiniMed™ 780G System in Europe, Middle East, and Africa Collected Over 3 Years: From Data to Clinical Evidence,” Diabetes Technol Ther (2024), 26(S3), 32-37.^

•Chien A et al., “Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system,” J Manag Care Spec Pharm (2023), 29(3), 285-292.^

•Christensen MB et al., “Automated Insulin Delivery in Adults With Type 1 Diabetes and Suboptimal HbA1c During Prior Use of Insulin Pump and Continuous Glucose Monitoring: A Randomized Controlled Trial,” J Diabetes Sci Technol (2024), 19322968241242399.*

•Collyns OJ et al., “Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes,” Diabetes Care (2021), 44(4), 969-975.*^

•De Meulemeester J et al., “One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study,” Diabetologia (2025), 68(5), 948-960.

•Diabetes Control and Complications Trial Research Group et al., “The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus,” N Engl J Med (1993), 329(14), 977-86.

•Di Molfetta S et al., “Efficacy and Safety of Different Hybrid Closed Loop Systems for Automated Insulin Delivery in People With Type 1 Diabetes: A Systematic Review and Network Meta-Analysis,” Diabetes Metab Res Rev (2024), 40(6), e3842.

•Drucker DJ, “Efficacy and Safety of GLP-1 Medicines for Type 2 Diabetes and Obesity,” Diabetes Care (2024), 47(11), 1873-1888.

•Ebekozien O et al., “Longitudinal Trends in Glycemic Outcomes and Technology Use for Over 48,000 People with Type 1 Diabetes (2016-2022) from the T1D Exchange Quality Improvement Collaborative,” Diabetes Technol Ther (2023), 25(11), 765-773.

•Edd SN et al., “ADAPT study Group. Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes,” Diabetes Obes Metab (2023), 25(11), 3212-3222.*^

•Fisher L et al., “Understanding the sources of diabetes distress in adults with type 1 diabetes,” J Diabetes Complications (2015), 29(4), 572-7.

•Forlenza GP et al., “Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes,” Diabetes Technol Ther (2024), 26(8), 514-525 (the “Forlenza 2024 study”).

•Gerhardsson P et al., “The SWEET Project 10-Year Benchmarking in 19 Countries Worldwide Is Associated with Improved HbA1c and Increased Use of Diabetes Technology in Youth with Type 1 Diabetes,” Diabetes Technol Ther (2021), 23(7), 491-499.

•Graham R et al., “Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study,” Diabetes Technol Ther (2024), 26(1), 24-32 (the “Graham 2024 study”).

•Hagger V et al., “Diabetes Distress Among Adolescents with Type 1 Diabetes: a Systematic Review,” Curr Diab Rep (2016), 16(1), 9.

•Hanaire H et al., “Cost-Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People with Type 1 Diabetes in France,” Diabetes Technol Ther. (2025), 27(10), 768-777.

•Hankosky ER et al., “Gaps Remain for Achieving HbA1c Targets for People with Type 1 or Type 2 Diabetes Using Insulin: Results from NHANES 2009-2020,” Diabetes Ther. (2023), 14(6), 967-975.

•Hwang JH et al., “Lifetime Health Effects and Cost-Effectiveness of Tirzepatide and Semaglutide in US Adults,” JAMA Health Forum (2025), 6(3), e245586.

•Jendle J et al., “A European Cost-Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes,” Diabetes Technol Ther (2023), 25(12), 864-876.*^

•Jendle J et al., “The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System in People with Type 1 Diabetes: a Health Economic Analysis in Sweden” Diabetes Ther (2021), 12(11), 2977-2991.*^

•Kessler L et al., “Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study,” Diabetes Ther (2025), 413-427.*^

•Kommareddi M et al., “Cost-effectiveness of the MiniMed 780G system for type 1 diabetes,” Am J Manag Care (2025), 31(4), e79-e86.*^

•Lambadiari V et al., “Cost-Effectiveness Analysis of an Advanced Hybrid Closed-Loop Insulin Delivery System in People with Type 1 Diabetes in Greece,” Diabetes Technol Ther (2022), 24(5), 316-323.*^

•Laurenzi A et al., “Insights into the effective use of the Smart MDI system: Data from the first 1852 type 1 diabetes users,” Diabet Med. (2025), 42(12), e70161.

•MacLeod J et al., “Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen,” Diabetes Technol Ther (2024), 26(1), 33-39.*^

•Matejko B et al., “Transitioning of People With Type 1 Diabetes From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to MiniMed 780G Advanced Hybrid Closed-Loop System: A Two-Center, Randomized, Controlled Study,” Diabetes Care (2022), 45(11), 2628-2635.*^

•Meade LT et al., “Accuracy of Carbohydrate Counting in Adults,” Clin Diabetes (2016), 34(3), 142-7.

•Messer LH et al., “Therapy Settings Associated with Optimal Outcomes for t:slim X2 with Control-IQ Technology in Real-World Clinical Care,” Diabetes Technol Ther. (2023), 25(12), 877-882 (the “Messer 2023 study”).

•Michaels VR et al., “Glucose and Psychosocial Outcomes 12 Months Following Transition from Multiple Daily Injections to Advanced Hybrid Closed Loop in Youth with Type 1 Diabetes and Suboptimal Glycemia,” Diabetes Technol Ther (2024), 26(1), 40-48.

•The National Health Service of England, “National Diabetes Audit Core Report 1: Care Processes and Treatemnt Targets 2023-24” (2024).

•Ozdemir Saltik AZ et al., “EE622 Improved Glycemic Outcomes and Associated Cost Savings with an Advanced Hybrid Closed Loop System for People with Type 1 Diabetes with Suboptimal Glycemic Control in Europe,” Value in Health (2023), 26(12), S172-S173.^

•Parker ED et al., “Economic Costs of Diabetes in the U.S. in 2022,” Diabetes Care (2024), 47(1), 26-43.

•Petrovski G et al., “Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents With Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed Loop System: A Randomized Controlled Trial Comparing Glucose Control,” Diabetes Care (2023), 46(3), 544-550.^

•Pöhlmann J et al., “A systematic literature review and meta-analysis of real-world evidence on commercially available automated insulin delivery systems in people with type 1 diabetes,” Diabetes Obes Metab. (2025) (the “Pöhlmann 2025 meta-analysis”).

•Resnick O et al., “Glucagon-like peptide-1 receptor agonists and type 1 diabetes: a potential game changer?” Front Endocrinol (Lausanne) (2025), 15, 1520313.

•Serné EH et al., “Automated Insulin Delivery Versus Standard of Care in the Management of People Living with Type 1 Diabetes and HbA1c <8%: A Cost-Utility Analysis in The Netherlands,” Diabetes Technol Ther. (2025), 27(8), 631-640.

•Shah VN et al., “Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study,” J Clin Endocrinol Metab (2019), 104(10), 4356-4364.

•Smaniotto V et al., “MiniMed 780G system performance in older users with type 1 diabetes: Real-world evidence and the case for stricter glycaemic targets,” Diabetes Obes Metab (2025), 27(4), 2242-2250.

•Sturt J et al., “The detection and management of diabetes distress in people with type 1 diabetes.” Curr Diab Rep (2015), 15(11), 101.

•Thrasher JR et al., “Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States,” Diabetes Technol Ther (2024), 26(S3), 24-31.*^

The data presented in Figures A and D in the sections of this prospectus entitled “Prospectus Summary” and “Business—Our Market” rely on the following sources: estimated market size based on last twelve months ended September 2025 revenue from public filings of leading diabetes device manufacturers as identified by Seagrove Partners; Seagrove Partners’ November 2025 WW Diabetes Master Forecast; and Seagrove Partners’ SeaTRAKMonitor Q3 2025 data (estimating the compound annual growth rate of the market for our products from 2025 to 2030). The Insulin Dependent Type 1 and Type 2 relative portion size of the figures represent our estimated market size for our diabetes technologies and other offerings based on last twelve months ended September 2025 revenue from public filings of leading diabetes device manufacturers as identified by Seagrove Partners.

The data presented in Figure C in the section of this prospectus entitled “Business—Our Products and Offerings” rely on the following sources: Beck RW et al., “Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial,” JAMA (2017), 317(4), 371-378; Bergenstal RM et al., “Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes,” JAMA (2016), 316(13), 1407-1408; Castañeda J et al., “Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System,” Diabetes Care. (2024), 47(5), 790-797; and Vigersky R et al., “The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes,” Diabetes Technol Ther. (2019), 21(2), 81-85.

The data presented in Figure F in the section of this prospectus entitled “Business—Our Products and Offerings” rely on the following sources: the Forlenza 2024 study; Castañeda J et al., “Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System,” Diabetes Care (2024), 47(5), 790–797; and Shah VN et al., “Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study,” The Journal of Clinical Endocrinology & Metabolism (2019), 104(10), 4356-4364.

The data presented in Figure G in the section of this prospectus entitled “Business—Our Products and Offerings” rely in part on Lingen K et al., “Advantages and disadvantages of connected insulin pens in diabetes management,” Endocrine Connections (2023), 12(11), e230108.

The data presented in Figure H in the section of this prospectus entitled “Business—Clinical / Real-World Evidence” rely on the following sources: Beck RW et al., “Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial,” JAMA (2017), 317(4), 371-378; Bergenstal RM et al., “Glucose Management Indicator (GMI): A New Term for Estimating A1C From Continuous Glucose Monitoring,” Diabetes Care (2018), 41(11), 2275-2280; Boucsein A et al., “Impact of Advanced Hybrid Closed Loop on Youth With High-Risk Type 1 Diabetes Using Multiple Daily Injections,” Diabetes Care (2023), 46(3), 628-632; Castañeda J et al., “Time in Tight Glucose Range in Type 1 Diabetes: Predictive Factors and Achievable Targets in Real-World Users of the MiniMed 780G System,” Diabetes Care (2024), 47(5), 790-797; Choudhary P et al., “Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study,” Lancet Diabetes Endocrinol. (2022), 10(10), 720-731; Choudhary P et al., “Celebrating the Data from 100,000 Real-World Users of the MiniMedTM 780G System in Europe, Middle East, and Africa Collected Over 3 Years: From Data to Clinical Evidence,” Diabetes Technology & Therapeutics (2024), 26(S3), 32-37; Elhenawy YI et al., “Performance of the MiniMed 780G system on mitigating menstrual cycle-dependent glycaemic variability,” Diabetes Obes Metab. (2024), 26(11), 4916-4923; the Forlenza 2024 study; Grosman B et al., “A Peek Under the Hood: Explaining the MiniMed 780G Algorithm with Meal Detection Technology,” Diabetes Technol Ther. (2024), 26(S3), 17-23; Jendle J et al., “A European Cost-Utility Analysis of the MiniMed 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes,” Diabetes Technol Ther. (2023), 25(12), 864-876; MacLeod J et al., “Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen,” Diabetes Technol Ther. (2024), 26(1), 33-39; and Matejko B et al., “Transitioning of People With Type 1 Diabetes From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to MiniMed 780G Advanced Hybrid Closed-Loop System: A Two-Center, Randomized, Controlled Study,” Diabetes Care (2022), 45(11), 2628-2635.

RISK FACTORS

An investment in shares of our common stock involves risks and uncertainties. In addition to the other information in this prospectus, you should consider carefully the factors set forth below before making an investment decision to purchase shares of our common stock. We seek to identify, manage, and mitigate risks to our business, but risks and uncertainties are difficult to predict and many are outside of our control and therefore cannot be eliminated. You should be aware that it is not possible to predict or identify all of these factors and that the following is not meant to be a complete discussion of all potential risks or uncertainties. If known or unknown risks or uncertainties materialize, our business, results of operations, financial condition, and cash flows could be adversely affected, potentially in a material way, which could result in a partial or complete loss of your investment.

Business and Operational Risks

We operate in a highly competitive industry and we may be unable to compete effectively.

We compete in the market for products and services for the management of T1D and T2D in approximately 80 countries. This market is intensely competitive and characterized by rapid change resulting from technological advances, innovations, and scientific discoveries. Competition may increase as additional companies enter this market or modify their existing products to compete directly with ours.

The product lines in which we compete include the components of our AID system, including insulin pumps like the MiniMed 780G and related consumables (such as infusion sets and insulin reservoirs) and our Simplera Sync and Guardian Connect CGM systems, as well as components of our Smart MDI system, including the InPen smart insulin pen and CGMs. In these product lines, we face a range of competitors from large companies with multiple business lines to small, specialized manufacturers that offer a limited selection of niche products. We compete with companies such as Beta Bionics, Inc.; Dexcom, Inc.; Insulet Corporation; Sequel Med Tech, LLC; Tandem Diabetes Care, Inc.; and Tecnicas Medioambientales Tecmed S.A. In addition, we face competition from providers of alternative medical therapies, such as pharmaceutical companies, including those producing GLP-1s.

Academic institutions, governmental agencies, and other public and private research organizations also may conduct research, seek patent protection, and establish collaborative arrangements for discovery, research, clinical development, and marketing of products similar to ours. These companies and institutions compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring necessary product technologies. Our newer mobile software applications such as the MiniMed Mobile app for the MiniMed 780G system and the MiniMed Go app are being designed to incorporate features and functions that are common to other consumer-oriented applications. These consumer industries are themselves highly competitive and characterized by continuous new product introductions, rapid developments in technology, and subjective and changing consumer preferences. If, in the future, PWD cease to view our products as contemporary or convenient as compared to then-existing consumer technology, our products may become less desirable.

Our competitors may currently enjoy or may develop several competitive advantages over us, including:

•greater financial and human resources for sales and marketing, product development, customer service, and clinical resources;

•greater ability to respond to competitive pressures, regulatory uncertainty, or challenges within the financial markets;

•established relationships with HCPs, third-party payors, and regulatory agencies;

•established reputation and name recognition among HCPs and other KOLs in the medical industry generally and the diabetes industry in particular;

•larger and more established distribution networks;

•greater ability to cross-sell products or provide incentives to HCPs to promote or support the use of their products; and

•more experience in conducting R&D, manufacturing, clinical trials, and obtaining regulatory approval or clearance.

As a result of our competitors’ advantages, we may not be able to compete effectively against these companies or their products, which may adversely impact our business. Development by our competitors of new or improved products, processes, or technologies, or the introduction of reprocessed products or generic versions when our proprietary products lose their patent protection, may make our existing or planned products less competitive. The introduction by competitors of products that are or claim to be superior to our products may create market confusion that may make it difficult to differentiate the benefits of our products over competing products. It is also possible that PWD interested in purchasing any of our future products currently under development may delay the purchase of one of our current products.

We believe our ability to compete depends upon many factors both within and beyond our control, including:

•product performance and reliability;

•product technology and innovation;

•product quality and safety;

•breadth of product lines;

•product support services;

•supplier and supply availability and performance;

•customer support;

•cost-effectiveness and price;

•reimbursement approval from healthcare insurance providers; and

•changes to the regulatory and reimbursement environment, including changes within the U.S. FDA and other regulators, including non-U.S. regulators.

Given these factors, we cannot guarantee that we will be able to compete effectively or continue our level of success. In the past we have lost, and may in the future lose, market share in connection with product problems, quality concerns and related warning letters from the U.S. FDA, physician advisories, safety alerts, and publications about our products, which highlights the importance of product safety, product efficacy, and quality systems to our business.

Competing products, therapeutic techniques, or other technological developments and breakthroughs for the monitoring, treatment, or prevention of diabetes may render our products obsolete or less desirable.

Our primary competitors, as well as a number of other companies and medical researchers, are pursuing new delivery devices, delivery technologies, therapeutic techniques, sensing technologies, treatment techniques, procedures, drugs, and other therapies for the monitoring, treatment, and prevention of diabetes. Any such breakthroughs by other parties in diabetes monitoring, treatment, or prevention could reduce the potential market for our products or render our products less desirable or obsolete altogether, which would significantly reduce our sales or cause our sales to grow at a slower rate than we currently expect. For example, emerging cellular therapeutic techniques such as islet cell therapy or immunotherapy could substantially alter the market for diabetes treatment and products. In addition, even the perception that new products may be introduced, or that technological or treatment advancements could occur, could cause consumers to delay the purchase of our products.

We have experienced, and may continue to experience, pricing pressure for certain products, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows.

In the current environment of managed care, consolidation among HCPs, increased competition, declining reimbursement rates, and national and provincial tender pricing, competitively priced product offerings are essential to our success. Some of our competitors employ aggressive pricing strategies, including the use of discounts, rebates, low-cost product upgrades, and other financial incentives that could adversely affect sales of our products. In addition, we have had, and may continue to have, periods when prices for certain products decrease due to pricing pressure from direct-to-consumer trends and managed care organizations and other third-party payors on PWD; increased market power of PWD as the healthcare industry consolidates; periodic variation in timing, volume, and pricing associated with PWD purchasing patterns and stocking dynamics; and increased competition among medical engineering and manufacturing services providers.

We have experienced, and anticipate that we will continue to experience, decreasing prices for our Simplera and Guardian Connect CGM products as a result of such pricing pressure. In addition, CGM products are also now covered in the pharmacy channel, and our competitors have broad coverage in the pharmacy channel and are able to offer enhanced rebates to both lower the out-of-pocket costs for patients and restrict other competitors from gaining similar coverage. Our CGM products have coverage at national pharmacy benefit health plans, but only a small percentage of our business flows through the pharmacy channel because PWD often can also get their CGMs through the DME channel. Our competitors’ and our distribution through the pharmacy channel could lower the prices PWD are willing to pay for our CGMs.

We have also recently experienced, and may continue to experience, rising costs due to heightened inflation and global trade policies. If the prices for our products change for any reason or inflation continues to remain at heightened rates, we may be unable to sufficiently reduce our expenses or offset rising costs through increased prices, we may become more reliant on our existing supplier arrangements, and our business, financial condition, results of operations, and cash flows could be adversely affected.

Challenges or delays in the development or manufacturing of new products, including in connection with required government approvals, could adversely affect our business, results of operations, financial condition, and cash flows.

We currently have a number of new products in our development pipeline, including the MiniMed Flex, our smaller, screenless, newly designed insulin pump; our next-generation Vivera dosing algorithm; and our MiniMed Fit patch pump with extended wear. Our ability to remain competitive in the markets in which we compete depends on our ability to anticipate and quickly respond to the needs and preferences of PWD, their caregivers and HCPs, and our third-party collaborators. Developing new products and technologies is a complex, time-consuming, and costly process. Any delay in the development or launch of a new product or technology could compromise our competitive position or otherwise adversely affect our business, results of operations, financial condition, or cash flows. We cannot predict with certainty when or whether we will be able to develop new products and technologies, or otherwise license or acquire new products and technologies.

The development and commercial launch timelines for our products depend a great deal on our ability to achieve clinical endpoints and satisfy regulatory requirements and to overcome technology challenges. These timelines may be delayed due to scheduling issues with patients and investigators, failure of patients to continue to participate in a clinical trial, requests from institutional review boards, inquiries from regulators about our independent and collaborative product development activities, product performance, or manufacturing supply constraints, among other factors. We and our development partners, as applicable, conduct extensive preclinical studies and clinical trials to demonstrate the safety and efficacy of our pipeline products in order to obtain regulatory approval for the marketing and sale of our pipeline products. Preclinical studies and clinical trials are expensive, complex, can take many years, and have uncertain outcomes. See “—The research and development efforts we undertake may not result in the development of commercially viable products, the generation of significant future revenues, or adequate profitability.”

Obtaining regulatory approvals from the U.S. FDA or other regulatory authorities, including non-U.S. regulatory authorities, for new products and devices and manufacturing processes can take a number of years and involves the expenditure of substantial resources. For example, we may face additional challenges with respect to European Medicines Agency (“EMA”) approval in the EU as a result of additional requirements for approval in the EU that may be more burdensome than those required by the U.S. FDA and other regulatory authorities. See “—Legal and Regulatory Risks—We are subject to extensive and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.” Even if we expend substantial resources during the regulatory approval process and believe our clinical results are sufficient to demonstrate product efficacy, there is no guarantee that the U.S. FDA, EMA, or any other regulatory authority will agree with us and grant our products regulatory approval.

Reduction or interruption in supply or other manufacturing difficulties may adversely affect our manufacturing operations and related product sales.

The manufacture of our products requires the timely delivery of a sufficient amount of quality components and materials and is highly exacting and complex, due in part to complex trade and strict regulatory requirements. Any failure to identify and address manufacturing problems prior to the release of products to PWD could result in quality or safety issues. We rely on third-party manufacturers to produce certain products, including our infusion sets, transmitters, and InPen smart insulin pens. While we manufacture a substantial portion of our products ourselves, we also procure critical third-party services, such as sterilization services, at numerous facilities worldwide. Efforts by the U.S. Environmental Protection Agency (the “U.S. EPA”) to regulate ethylene oxide (“EtO”) use in sterilization may reduce the device sterilization capacity of our third-party sterilizers. We purchase many of the components, raw materials, and services needed to manufacture these products from numerous suppliers in various countries. We have generally been able to obtain adequate supplies of such components, raw materials, and services, although global shortages of certain components such as semiconductors and resins have recently caused, and may in the future cause, disruptions to our product manufacturing supply chain. A reduction or interruption in supply, and an inability to develop alternative sources for such supply, on satisfactory terms or at all, could adversely affect our ability to manufacture our products in a timely or cost-effective manner and could result in lost sales or a failure to meet our contractual supply obligations under government tenders. Additionally, any inability to develop such an alternative source of supply in a cost-effective manner, including an inability to maintain margins and pass along increased costs to our customers, could adversely affect our business, financial condition, results of operations, and cash flows.

Disruptions in the manufacturing process or product sales, trade, and fulfillment systems for any reason, including: infrastructure, information, and equipment malfunction; failure to follow specific protocols and procedures; supplier or Company facility shut-downs; regulatory action by the U.S. FDA, U.S. EPA, or other regulatory authorities; defective raw materials; labor shortages; natural or man-made disasters such as hurricanes, tornadoes, earthquakes, or wildfires; property damage or facility closures from riots or public protests; other environmental factors, including climate change; and the impact of epidemics, pandemics, or other public health crises, and actions by businesses, communities, and governments in response, could lead to launch delays, product shortages, unanticipated costs, lost revenues, or damage to our reputation. The imposition of trade restrictions, such as new tariffs or increases in existing tariffs on products imported from countries where our manufacturers or suppliers operate, increase the costs for raw materials and finished goods. Some of our products or underlying components are manufactured in China and may become subject to tariffs. See “—We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results.” The prices of commodities and other materials used in our products, which are often volatile and outside of our control, could adversely impact our profitability. We use resins, other petroleum-based materials, and pulp as raw materials in some of our products, and the prices of oil and gas also significantly affect our costs for freight and utilities.

We obtain some of the components, raw materials, and services needed to manufacture our products from sole suppliers, and the partial or complete loss of one or more of these suppliers could adversely impact our business, results of operations, financial condition, and cash flows.

For reasons of quality assurance, cost-effectiveness, or availability, many key components, raw materials, and services needed to manufacture our products are obtained from sole suppliers with no alternatives yet identified. In

addition, the design and formulation of certain of these components and materials are proprietary and the intellectual property rights may be owned exclusively by one party. For certain of these sole-sourced components, materials, and services, alternatives may not be readily available. Any alternative supplier arrangement may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in our manufacturing process to transition to a new supplier, particularly in cases in which we must comply with regulatory requirements relating to qualification of new suppliers.

Our sole suppliers include Convatec Group plc for our infusion sets, Intricon Corporation for transmitters, and Steris plc and Steri-Tech Inc. for sterilization services. Our dependence on such sole suppliers subjects us to possible risks of shortages, interruptions, and price fluctuations. Certain of our sole suppliers are subject to regulation by the U.S. FDA and other regulatory bodies and as a result may be subject to regulatory actions such as warning letters or recalls that could cause disruption in supply. On January 8, 2026, Unomedical Device S.A. de C.V., a subsidiary of Convatec Group plc, received a warning letter from the U.S. FDA as the legal manufacturer of its infusion sets, including those sold to us, pertaining to process validation, complaint investigation, corrective and preventive actions, and medical device reporting. While we have not received indication of any potential supply disruption, the U.S. FDA investigation could result in field corrective actions or further enforcement action that could have an impact on supply. Disruptions or loss of any of our sole suppliers, or capacity limitations of the suppliers for components, could increase our costs, curtail growth opportunities, cause material delays, and adversely impact our business, results of operations, financial condition, and cash flows. If our sole suppliers move their manufacturing and assembly sites to other locations, depending on the circumstances and nature of the item supplied, in addition to quality system activities such as verification and validation, there could be a need for U.S. FDA or international regulator notifications or submissions, the new locations could be subject to regulatory inspection, or our costs could increase due to differing trade restrictions or tariffs. Any resulting regulatory delays or impediments impacting such sole suppliers could also adversely impact our business, results of operations, financial condition, and cash flows.

We may not succeed in developing new high-volume manufacturing lines for products that meet our requirements for quality, yield, throughput, and other performance metrics. Furthermore, any new high-volume manufacturing lines we develop may be unreliable, require regular and significant maintenance, and be capital and resource-intensive to operate.

Our ability to fully optimize costs while manufacturing our products at scale depends on the successful development of new high-volume manufacturing lines that meet our requirements for quality, throughput, yield, and other performance metrics. We may not succeed in developing such high-volume manufacturing capabilities that will meet the standards required to successfully mass market our products. For example, our production of Simplera CGM products is scaling slower than anticipated due to our initial unsuccessful attempts to develop high-volume automated manufacturing lines for our Simplera CGMs. The initially developed Simplera CGM high-volume automated manufacturing lines were not sufficiently customized to product design specifications and lacked the software capabilities required for successful automation, and as a result failed to meet our throughput and yield requirements. We recently terminated certain arrangements with a third-party manufacturer with whom we contracted to install and operate one of these Simplera CGM high-volume automated manufacturing lines in an offsite location, and we recorded a related pre-tax charge of $118 million during the quarter ending January 23, 2026. For more information on this charge, see Note 16, “Subsequent Events,” to the unaudited condensed combined financial statements included elsewhere in this prospectus.

Our ongoing and future attempts to develop high-volume automated manufacturing lines for Simplera CGMs and/or other products will require significant time, resources, and expense, and may not be successful. Even if we are ultimately successful in developing high-volume manufacturing capabilities, we do not know whether we will be able to do so in a manner that avoids cost overruns or additional delays and/or impairment charges (including as a result of factors beyond our control such as problems with suppliers and vendors or force majeure events), meets our product commercialization and manufacturing schedules, and satisfies the requirements of customers and potential customers. Moreover, although we continue to develop and enhance opportunities for efficient work processes, including using robotic technology and other artificial intelligence (“AI”) capabilities, an inability to automate processes in our high-volume manufacturing facilities could result in increases in labor costs. If we are unable to successfully develop high-volume manufacturing lines for our products, it could negatively impact our ability to fully optimize costs while manufacturing our products at scale and could adversely impact our ability to meet market

demand for our products, each of which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our current products may not maintain, and our next-generation products may not achieve or maintain, market acceptance.

Our current business and growth strategy is highly dependent on our products, especially our next-generation products, achieving and maintaining market acceptance. A key to maintaining and growing our revenue is the retention of a high percentage of our customers due to the significant revenue generated from ongoing purchases of CGMs, other consumables, software, and services used with our AID and MDI systems. Market acceptance and adoption of our next-generation AID systems and Smart MDI systems depend on educating PWD, as well as their caregivers and HCPs, about the distinct features, ease-of-use, beneficial treatment outcomes, and other perceived benefits of these products as compared to competing products, including traditional CGMs and insulin pump products and alternative diabetes monitoring, treatment, or prevention methodologies. If we are not successful in convincing existing and potential customers of the benefits of our products, or if we are not able to achieve the support of caregivers and HCPs for our products, our sales may decline or we may achieve sales below our expectations.

Market acceptance of our current and next-generation products could be negatively impacted by many factors, including:

•our products not containing features desired by certain PWD, such as dual-analyte glucose-ketone sensors;

•the failure of our products to achieve or maintain wide acceptance among people with T1D or T2D, their caregivers, HCPs, and KOLs in the diabetes treatment community;

•the failure of our products to achieve or maintain acceptance by third-party payors for coverage and reimbursement;

•lack of evidence supporting the safety, effectiveness, ease-of-use, or other perceived benefits of our products over competing products or other currently available glucose monitoring or insulin treatment methodologies;

•perceived risks or uncertainties associated with the use of our products, or components thereof, or of similar products or technologies of our competitors;

•adverse regulatory or legal actions relating to our products or similar products or technologies;

•results of clinical studies relating to our current or next-generation products, or similar competitive products;

•failure to adapt to business model and other industry changes, including responding to evolving PWD needs and service expectations; and

•criticism on digital and social media platforms, negative coverage by traditional media, and other forms of adverse publicity regarding our products or brand.

If our products do not achieve and maintain widespread market acceptance, we may fail to achieve sales consistent with our projections, in which case our business, results of operations, financial condition, and cash flows could be materially and adversely affected.

The research and development efforts we undertake may not result in the development of commercially viable products, the generation of significant future revenues, or adequate profitability.

In order to address the anticipated needs of PWD, pursue new markets for our existing products and any new products, and to remain competitive, we focus our research and development efforts and related strategic third-party collaboration activities on the enhancement of our current diabetes management products, the development of next-

generation products, and the development of novel technologies and services. The development of new products or novel technologies and services and the enhancement of our current products requires significant investment in research and development, intellectual property protection, clinical trials, regulatory approvals, and obtaining third-party reimbursement. Certain of our next-generation products, including the MiniMed Go, our next-generation MDI system with single app integration; the MiniMed Flex, our smaller, screenless, newly designed insulin pump; our next-generation Vivera dosing algorithm; and the MiniMed Fit patch pump, are subject to a heightened level of risk with respect to technical feasibility and manufacturability. In particular, it is critical to the growth and profitability of our business that we develop or acquire a cost-effective competitive CGM sensor and a patch pump, and doing so may take longer or require more resources than anticipated. Even if our next-generation products are technically feasible and manufacturable at scale, there is no guarantee that such products will be successful entrants in the marketplace. See “—Our current products may not maintain, and our next-generation products may not achieve or maintain, market acceptance.”

The results of our product development and commercialization efforts may be affected by a range of factors, including our ability to anticipate PWD needs, innovate and develop new products (whether independently or with our partners), determine a feasible or timely regulatory pathway or approach, and launch those products cost-effectively into multiple markets and geographies. If we are unable to successfully anticipate PWD needs, innovate, develop new products, and successfully launch them, we may not be able to generate significant future revenues or profits from these efforts. The ultimate benefit we realize from the successful launch of a new or next-generation product may be negatively impacted if the new product cannibalizes sales of our existing products beyond expected levels.

Our success depends on our ability to differentiate our products and keep pace with emerging technologies.

Our continued growth and success depend on our ability to develop, acquire, and market new and differentiated products, technologies, and intellectual property, and as a result we also face competition for marketing, distribution, and collaborative development agreements, establishing relationships with academic and research institutions, and acquiring licenses to intellectual property. In order to continue to compete effectively, we must continue to create, invest in, or acquire advanced technology, incorporate this technology into our proprietary products, obtain regulatory approvals in a timely manner, and manufacture and successfully market our products. For example, data science, machine learning, and AI are all impacting our products and operations and the competitive landscape in which we operate, and the application of these technologies is rapidly evolving at the same time as new laws and regulations of AI are being developed in jurisdictions around the world. There are significant risks involved in utilizing AI, and compliance with developing regulations may require significant expenditures or may limit our ability to effectively use these technologies. There can be no assurance that the application of AI in our products and operations will be successful, or that we will not experience data security and privacy incidents in connection with our use of these technologies. Given these factors, we cannot guarantee that we will be able to compete effectively or continue our level of success.

We enter into development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, and partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues and that could potentially inhibit us from pursuing certain product development and acquisition opportunities outside of such arrangements.

In the ordinary course of our business, we enter into development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, or partnerships to develop proposed products or technologies, pursue new markets, or protect our intellectual property assets. For example, we rely on third parties, such as contract research organizations, medical institutions, clinical investigators, and contract laboratories, to conduct some of our clinical trials and pre-clinical investigations. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to failure to adhere to our clinical protocols or regulatory requirements or for other reasons, or if they are delayed in conducting our clinical trials for reasons outside of their control, our pre-clinical development activities or clinical trials may be extended, delayed, suspended, or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis or at all. We also enter into investments in and with other medical technology companies. These investments are inherently risky, and

we cannot guarantee that any of our previous or future investments will be successful or will not materially adversely affect our business, results of operations, financial condition, and cash flows.

We may not be able to identify or complete any such development arrangement in a timely manner, on a cost-effective basis, on acceptable terms, or at all, and we may not realize the anticipated benefits of any such development arrangements that we do identify and complete. In particular, these development arrangements may not result in the development of products or technologies that achieve commercial success or result in positive financial results, or may otherwise fail to have the intended impact on our business.

We may elect to amend or modify development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, partnerships, or similar agreements that we already have in place. Proposing, negotiating, and implementing development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, or partnerships may be a lengthy and complex process, and may subject us to business risks. For example, other companies, including those with substantially greater financial, marketing, sales, technology, or other business resources, may compete with us for these opportunities, or may be the counterparty in any such arrangements.

Additionally, we may not be in a position to exercise sole decision-making authority regarding a development arrangement, investment, licensing, or other similar arrangement, which could create the risk of impasses on decisions. Further, our collaborators and business partners may have economic or business interests or goals that are, or that may become, inconsistent with our business interests or goals. It is possible that conflicts may arise with our collaborators and other business partners, including conflicts concerning the achievement of performance milestones, or the interpretation of significant terms under any agreement, such as those related to financial obligations, termination rights, or the ownership or control or other licenses of intellectual property rights. If any conflicts arise with our current or future collaborators, they may act in their self-interest, which may be adverse to our best interest, and they may breach their obligations to us. In addition, we have limited control over the amount and timing of resources that our current collaborators or any future collaborators devote to our arrangements with them or our future products. Disputes between us and our current, future, or potential collaborators may result in litigation or arbitration which would increase our expenses and divert the attention of our management. Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the applicable agreements and, in such event, we may not continue to have rights to the products relating to such transaction or arrangement or may need to purchase such rights at a premium.

We are party to certain agreements with affiliates of Blackstone Life Sciences Advisors L.L.C. (collectively, “Blackstone”) pursuant to which we have received funding for expenses related to the development of specific Diabetes products (each, a “Blackstone Agreement” and collectively, the “Blackstone Agreements”). The Blackstone Agreements for which there are ongoing development and commercialization plans relate to our next-generation MiniMed Flex insulin pump and MiniMed Fit patch pump. Our engineering, clinical, and regulatory teams are performing the development work for the programs funded by the Blackstone Agreements. If successfully commercialized, we will pay royalties on the developed products to Blackstone. Under certain termination provisions of the Blackstone Agreements, our royalty payment obligation will survive, and in certain termination circumstances, a payment to Blackstone of a multiple of the funded amounts may be required. If we acquire rights to a product in certain specified markets that competes with a product subject to a Blackstone Agreement, Blackstone has the option to terminate the agreement and receive a termination payment from us equal to a multiple of the funded amounts under the applicable agreement, or continue to be eligible for the royalty payments on the product subject to the Blackstone Agreement; provided that if the product subject to the Blackstone Agreement has already been submitted for regulatory approval for commercial use at the time the competing product is acquired and Blackstone elects to receive royalty payments, such royalty payments would apply to both the product subject to the Blackstone Agreement and the competing product. Such termination payments could potentially discourage us from pursuing, or limit our resources to pursue, certain product development and acquisition opportunities outside of the arrangements, increase our cash requirements, and could impair our liquidity, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows. For additional information about our research and development arrangements with Blackstone, including prior instances of terminations of Blackstone Agreements, see “Business—Innovation / Pipeline and Future Initiatives—Blackstone Co-Development Agreements.”

On July 31, 2024, we entered into a global integration, supply, and distribution agreement with Abbott (the “Abbott Partnership”) to expand access to our AID and Smart MDI systems. Under the Abbott Partnership, Abbott will supply us with Instinct, an alternative CGM sensor based on Abbott’s most advanced single-analyte CGM technology. Achieving the anticipated benefits of the Abbott Partnership is subject to a number of uncertainties, including whether our AID and Smart MDI systems and the Instinct CGM platform can become integrated in an effective and efficient manner. Furthermore, Abbott’s future dual glucose-ketone sensors are not currently included under the Abbott Partnership, and these sensors may ultimately be preferred by PWD. As of the time of this offering, our CGM offerings consist of single-analyte sensors that monitor glucose levels. A glucose-ketone sensor would enable PWD to continuously monitor glucose and ketone levels in one sensor, so that rising ketone levels can be detected early as a potential warning sign of impending diabetic ketoacidosis. Failure to achieve the anticipated benefits of the Abbott Partnership, on our currently expected timeline or at all, could result in increased costs, decreases in the amount of expected revenues generated by the Abbott Partnership, and diversion of our management’s attention and energy away from ongoing business operations. We may also experience a decline in sales of our existing CGMs as we market Instinct alongside our own CGMs, such as our Simplera and Guardian Connect CGM products. The failure to successfully integrate Instinct into our existing marketing efforts could have a material adverse effect on our business, results of operations, financial condition, and cash flows. Additionally, if Abbott were to have its marketing authorization revoked or if it encountered other difficulties that negatively affected the public’s perception of and use of Abbott’s CGM products, it could have a corresponding adverse effect on the public perception of and use of our other products. For additional information about the Abbott Partnership, see “Business—Innovation / Pipeline and Future Initiatives—Abbott Integration, Supply and Distribution Agreement.”

The continuing development of many of our products depends upon our ability to maintain strong relationships with HCPs.

If we fail to maintain our working relationships with HCPs, many of our products may not be developed and marketed in line with the professionals who support and promote our products, which could cause a decline in our earnings and profitability. The research, development, marketing, and sales of many of our new and improved products depend on our maintaining working relationships with HCPs. We rely on these professionals to provide us with considerable knowledge and experience regarding the research, development, marketing, and sales of our products. HCPs assist us as researchers, marketing and product consultants, inventors, trainers, and public speakers. If we are unable to maintain strong relationships with these professionals, the development and marketing of our products could suffer, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our results of operations will be harmed if we are unable to accurately forecast market demand for our products and manage our inventory.

To ensure adequate supply of our products, we must forecast the inventory needs of our current and prospective customers and manufacture our products based on our estimates of future demand. Our ability to accurately forecast market demand for our products could be negatively affected by many factors, many of which are beyond our control, including our failure to accurately manage our expansion strategy, product introductions by competitors, an increase or decrease in customer demand for our products or for products of our competitors, our failure to accurately forecast market acceptance of new products, and changes in general market conditions or regulatory matters.

Failure to adequately predict market demand for our products or otherwise optimize and operate our distribution channels successfully could result in excess or insufficient inventory or fulfillment capacity, increased costs, immediate shortages in product or component supply, or harm our business in other ways. Disruptions in international markets and supporting financial services and uncertainty about economic conditions (for instance, resulting from tariff disputes, credit scarcity, geopolitical risks, and sovereign debt deterioration) have in the past caused periods of tightened credit availability and increased volatility in liquidity and borrowing terms. If these conditions were to recur or worsen, we may experience reduced demand for a number of our products. We also could experience reduced sales, cash flows, and profits due to delayed payments or the insolvency of customers, HCPs, hospitals, suppliers, distributors, or vendors who experience liquidity issues, including as a result of

cybersecurity incidents impacting private and government health insurance payors. In addition, HCPs and staff strikes or other work stoppages may in the future cause reduced demand for our products. As a result, our business, results of operations, financial condition, and cash flows could be adversely affected.

If we fail to expand and maintain an effective sales force, predict and adapt to changes in markets, or successfully develop and maintain our relationships with intermediaries, our business, prospects, and brand may be materially and adversely affected.

We must continue to develop and grow our sales and marketing organization, enter into partnerships or other arrangements to market and sell our products, and collaborate with third parties, including distributors, to market and sell our products in order to maintain the commercial success of our current systems and to achieve commercial success for our future products. Our sales and marketing organization competes with the experienced, larger, and well-funded marketing and sales operations of our competitors. Further, we may not be able to successfully manage our dispersed sales force or increase our product sales at acceptable rates. If we are unable to establish and maintain adequate sales, marketing, and distribution capabilities, independently or with others, our future revenue may be reduced and our business may be harmed.

Our direct sales and marketing team calls on HCPs and PWD throughout the applicable country, to the extent permissible, to raise awareness and initiate sales of our products. Developing and managing a direct sales organization is a difficult, expensive, and time-consuming process. To continue to develop our direct sales and marketing organization to successfully achieve market awareness and sell our products, we must:

•recruit and retain adequate numbers of effective and experienced sales and marketing personnel;

•launch new products on a timely and frequent basis to ensure that our sales and marketing team consistently has a lineup of products to sell;

•compensate our marketing and sales personnel appropriately compared to competitors;

•effectively train our sales and marketing personnel in the benefits and risks of our products;

•establish and maintain successful sales, marketing, training, and education programs that educate HCPs, including endocrinologists, physicians, and diabetes educators, so they can appropriately inform PWD about our products;

•manage geographically dispersed sales and marketing operations; and

•effectively train our sales and marketing personnel on the applicable advertising and promotion and fraud and abuse laws that govern interactions with HCPs and institutions, as well as current and prospective patients, and maintain active oversight and auditing measures to ensure continued compliance.

We enter into co-promotion and other marketing and sales arrangements with other companies. Any revenue received from those arrangements depends on the skills and efforts of others, and we cannot predict whether these efforts will be successful.

To the extent that we enter into additional arrangements with third parties or intermediaries to perform sales, marketing, distribution, or billing services, our product margins could be lower than if we directly marketed and sold our products. Intermediaries that are in the business of selling other medical products in addition to our products may not devote a sufficient level of resources and support required to generate awareness of our products and grow or maintain our product sales. If our intermediaries are unwilling or unable to market and sell our products, or if they do not perform to our expectations, we could experience delayed or reduced market acceptance and sales of our products, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows. See “—We enter into development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues.” and “—Reduction or interruption in supply or other manufacturing difficulties may adversely affect our manufacturing operations and related product sales.” for a more detailed discussion on risks relating to our relationships with third parties.

Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we have, and in the future expect to, publicly disclose interim, top-line, or preliminary data from our pre-clinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of interim, top-line, or preliminary data, and we may not have received or had the opportunity to fully and carefully evaluate all data. The interim, top-line, or preliminary results that we report may differ from future results of the same study or trial, different conclusions or considerations may qualify such results, or one or more of the clinical outcomes may materially change, once additional data have been received and fully evaluated. Interim, top-line, or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim, top-line, or preliminary data we previously announced. As a result, interim, top-line, and preliminary data should be viewed with caution until the final data are available. Adverse differences between interim, preliminary, or top-line data and final data could significantly harm our business prospects. Further, disclosure of interim, preliminary, or top-line data by us or by our competitors could result in volatility in the price of our common stock. If the interim, top-line, or preliminary data that we report differ from actual results, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could adversely impact our business, results of operations, financial condition, and cash flows.

Future market or clinical studies may be unfavorable to our products and their efficacy, which could hinder our sales efforts and have a material adverse effect on our business, results of operations, financial condition, and cash flows.

To help improve, market, and sell our products, we have sponsored, and expect to continue to sponsor, market studies to assess various aspects of the functionality and relative efficacy of our products. The data obtained from the studies may be unfavorable to our products or may be inadequate to support satisfactory conclusions. In addition, we may sponsor clinical trials to assess certain aspects of the efficacy of our products. If future clinical trials fail to support the efficacy of our current or future products, our sales may be adversely affected and we may lose an opportunity to secure clinical preference from prescribing clinicians, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Future clinical studies or articles regarding our existing products or any competing products may be published that either support a claim, or are perceived to support a claim, that a competitor’s product is clinically more effective or easier to use than our products or that our products are not as effective or easy to use as we claim. Diabetes associations, HCPs that focus on diabetes, or other organizations that may be viewed as authoritative could endorse products or methods that compete with our products or otherwise announce positions that are unfavorable to our products. Any of these events may negatively affect our sales efforts and result in decreased revenue.

We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results.

We develop, manufacture, distribute, and sell our products globally. We intend to continue to expand our operations and to pursue growth opportunities in new and emerging markets. Operations in different countries including emerging markets could expose us to additional and greater risks and potential costs, including:

•fluctuations in currency exchange rates;

•healthcare reform legislation;

•the need to comply with different regulatory regimes worldwide that are subject to change and that could restrict our ability to manufacture and sell our products;

•local product preferences and product requirements;

•longer-term receivables than are typical in the United States;

•economic sanctions, export controls, trade protection measures, tariffs and other border taxes, and import or export licensing requirements;

•less intellectual property protection in some countries outside the United States than exists in the United States;

•different labor regulations and workforce instability;

•political and economic instability, including as a result of armed conflicts and insurrections;

•restrictions on local currency conversion or cash extraction;

•potentially negative consequences from changes in or interpretations of tax laws; and

•economic instability, heightened inflation, recession, or interest rate fluctuations.

The ongoing global economic competition and trade tensions among the United States and various other countries, such as China, present risk to us. Recently, the United States has imposed new tariffs on imports from many jurisdictions, including, Canada, Mexico, China, the European Union, and other countries and regions in which we do business. The United States has indicated that these tariffs are subject to change and that additional tariffs may be imposed against other countries. The United States, China, and the EU, which comprised approximately 29.6%, 1.3%, and 42.5% percent, respectively, of our total net sales in the six months ended October 24, 2025 and 33%, 2%, and 39%, respectively, of our total net sales in fiscal year 2025, could impose tariffs or other types of restrictions such as limitations on government procurement or technology export restrictions, which could affect our access to the markets.

The Russia-Ukraine conflict and resulting sanctions and export restrictions are creating barriers to doing business in Russia and Belarus and are adversely impacting global supply chains. While we have no manufacturing or direct material suppliers in the region, we continue to closely monitor the potential raw material / sub-tier supplier impact in both Russia and Ukraine. Additional sanctions, export restrictions, and potential countermeasures within Russia, along with geopolitical shifts in Asia and disruptions relating to conflicts in the Middle East, may lead to greater uncertainty that could cause additional adverse impacts on global supply chains and our business, results of operations, financial condition, and cash flows.

More generally, several governments including the United States have raised the possibility of policies to induce “re-shoring” of supply chains, less reliance on imported supplies, and greater national production. If such steps trigger retaliation in other markets restricting access to foreign products in purchases by their government-owned healthcare systems, the result could have a significant impact on us.

Other significant changes or disruptions to international trade arrangements, such as termination or modification of existing trade agreements, may adversely affect our business, results of operations, financial condition, and cash flows. In addition, a significant amount of our trade receivables are with national healthcare systems in many countries. Repayment of these receivables is dependent upon the political and financial stability of those countries. In light of these global economic fluctuations, we continue to monitor the creditworthiness of customers. Failure to receive payment of all or a significant portion of these receivables could adversely affect our business, results of operations, financial condition, and cash flows.

Finally, changes in currency exchange rates may impact the reported value of our revenues, expenses, and cash flows. In addition, the impact of currency devaluations in countries experiencing significant currency exchange fluctuations could negatively impact our operating results. We cannot predict changes in currency exchange rates, the impact of exchange rate changes, or the degree to which we will be able to manage the impact of currency exchange rate changes.

Failure to secure or retain adequate coverage or reimbursement for our current products and our potential future products by government entities or third-party payors could adversely affect our business, results of operations, financial condition, and cash flows.

As a medical device company, reimbursement from government and private third-party payors, including Medicare and Medicaid, is an important element of our success. Future sales of our current and future products will be limited unless PWD can rely on third-party payors to pay for all or part of the associated purchase cost. Access to adequate coverage and reimbursement for our current and future products by third-party payors is essential to the acceptance of our products by PWD, as well as their caregivers and HCPs.

As guidelines in setting their coverage and reimbursement policies, many third-party payors in the United States reference coverage decisions and reimbursement amounts determined by the Centers for Medicare & Medicaid Services (“CMS”), which administers the U.S. Medicare program. CMS periodically reviews Medicare coverage and reimbursement policies for diabetes-related products, and there is uncertainty as to the future Medicare reimbursement rate for our products. For example, the United States government may shift health policy priorities, which could impact Medicare coverage and reimbursement. It is also possible that CMS may continue to review and modify the current coverage and reimbursement of diabetes-related products in connection with anticipated changes to the regulatory approval process for CGMs, insulin pumps, and related products, software applications, and services.

CMS recently finalized the Home Health rule that will include Class II CGMs and insulin pumps in its Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) competitive bidding program (“CBP”). CMS expects contracts to be awarded to approximately ten suppliers of Class II CGMs and insulin pumps, and that the initial contracts will be awarded in the second half of 2027 and be effective January 1, 2028. Upon receipt of Pricing, Data Analysis and Coding (PDAC) approval from Medicare, we expect to sell Class II CGMs and insulin pumps to Medicare beneficiaries in connection with our AID systems that utilize Instinct CGM sensors, both directly and indirectly through distributors. To continue to serve as a DMEPOS provider for such Medicare fee-for-service beneficiaries, both we and the distributors with whom we partner will be required to successfully bid in the DMEPOS CBP. We also expect the DMEPOS CBP to lower Medicare reimbursement rates below current rates for Class II CGMs and insulin pumps, and these lower rates to be used as benchmarks for the reimbursement rates for Class III CGMs and insulin pumps sold to Medicare beneficiaries and for all CGMs and insulin pumps reimbursed by third-party providers, and that this will decrease the amount we are able to charge for these products in the United States. Furthermore, the payment classification for Class II CGMs and insulin pumps under the updated DMEPOS CBP will shift to the “frequently and substantially serviced” category rental model. Under this model, insulin pumps will move from a capped rental over a 13-month period to a monthly rental with payment calculated by total rental cost divided by 60 months, which we expect to impact the timing of revenue recognition and cash flows related to Class II insulin pump sales to Medicare patients, and to create a risk of loss in the event a pump (which is not reusable) is returned by a Medicare patient within 60 months. If the new DMEPOS CBP payment model is also adopted for Class III insulin pumps sold to Medicare beneficiaries and by third-party payors generally, these impacts to insulin pump-related revenue recognition and cash flows, and risk of loss if a pump is returned, would be more significant. In addition, if we, or the distributors with whom we currently partner, do not elect to participate in the DMEPOS CBP or are unsuccessful in winning bids, we may need to partner with new distributors to continue selling Class II CGMs and insulin pumps to Medicare beneficiaries. Furthermore, the terms of our arrangements with distributors will likely need to change to reflect new commercial dynamics created by the DMEPOS CBP, which could result in less favorable terms for us with respect to sales of our CGMs and insulin pumps.

Third-party payors that do not follow CMS guidelines may adopt different coverage and reimbursement policies for our current and future products. Third-party payors are increasingly basing reimbursement rates on the effectiveness of the product, clinical outcomes associated with the product, product-specific health economic outcomes data demonstrating cost savings, and any factors that negatively impact the effectiveness or clinical outcomes (or cause a perception of any such negative impact), such as the results of a clinical trial or a product recall or corrective action, which could negatively impact the reimbursement rate. Further, it is possible that some third-party payors will not offer any coverage for our current or future products. For instance, it is possible that third-party payors may adopt policies in the future that designate one or more of our competitors as their preferred, in-network DME provider of CGMs and that such policies would discourage or prohibit the payors’ members from purchasing

our products, which would adversely impact our ability to sell our products. With the evolution of health plan coverage to reimburse products under the pharmacy benefit, payors have the ability to exclude products from formulary coverage.

Both government and private third-party payors managing the pharmacy benefit establish formularies to control costs by taking into account manufacturer rebates in connection with decisions about formulary inclusion or preferred formulary placement. Failure to offer or maintain competitive rebates to maintain formulary placement could adversely impact revenue. Private third-party payors, including self-insured employers, often implement formularies with co-payment tiers to encourage utilization of certain products and have also been raising co-payments required from beneficiaries, particularly for higher-cost products. Private third-party payors may also use additional measures such as value-based pricing or contracting to improve their cost-containment efforts. Private third-party payors also are increasingly imposing utilization management tools, such as requiring prior authorization or requiring the patient to first fail on a lower-cost product before permitting access to a higher-cost product.

In some countries, particularly EU countries and European Free Trade Association (EFTA) member states, the pricing, reimbursement, and rebates of health products are subject to governmental control, and in such countries, there can be considerable pressure by governments and other stakeholders on prices, as well as reimbursement and rebates. If reimbursement for our products in these countries is unavailable or limited in scope or amount, or if pricing or rebates are set at unsatisfactory levels in any such country, our prospects for generating revenue outside of the United States, if any, could be adversely affected and our business could be harmed. We are subject to risks relating to changes in government and private medical reimbursement programs and policies, and changes in legal and regulatory requirements around the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating to coverage of or reimbursement for our products by administrators of these systems, could have an impact on the acceptance of and demand for our products and the prices that PWD are willing to pay for them. If we expand our sales and marketing efforts internationally, we will face additional risks associated with obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all.

We currently have contracts establishing reimbursement for our products with national and regional third-party payors in the United States. While we may enter into additional contracts in the United States and expand coverage of certain products, as well as add coverage for future products under our current agreements, we cannot guarantee that we will succeed in doing so or that the reimbursement contracts that we are able to negotiate will enable us to sell our products on a profitable basis. In order to obtain additional health plan contracts, including with pharmacy benefits plans, we may have to agree to a net sales price lower than the net sales price we obtain in other payor channels. Our existing reimbursement contracts generally include numerous quality and compliance-related requirements, including audit rights, and can be terminated by government entities or third-party payors without cause and with little (30 to 60 days’) notice to us. Our compliance with the administrative procedures or requirements may result in increased costs for us and delays in processing approvals by government entities and third-party payors, and any payor audits of our compliance obligations may result in requests for refunds or other costs. In addition, as noted above, government decisions on coverage and reimbursement amounts may impact the reimbursement rates we are able to obtain from third-party payors. Failure to secure or retain adequate coverage of or reimbursement for our current and future products by government entities and third-party payors, or delays in processing approvals by those payors, could result in the loss of sales, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

As most of our customers rely on third-party payors to cover the cost of our products, there has been, and may continue to be, a shift in financial responsibility to our customers for the amounts previously covered by their primary insurance carrier. In the event that we are unsuccessful in collecting payments owed by customers or experience increases in the amount, or deterioration in the collectability, of uninsured and patient due accounts receivable, this could adversely affect our business, results of operations, financial condition, and cash flows. We may also be adversely affected by the growth in high deductible or “skinny” health plan offerings, as a result of the evolving healthcare policy and insurance landscapes that shift greater responsibility for care to individuals through more exclusions, prior authorizations, and higher co-payment and deductible amounts.

Failure to integrate any acquired businesses into our operations successfully, or challenges related to our strategic initiatives, including divestitures and third-party funding arrangements, as well as liabilities or claims relating to any such acquired businesses, divestitures, or arrangements could adversely affect our business.

As part of our strategy to develop and identify new products and technologies and optimize our portfolio of products, we have made several acquisitions, divestitures, and third-party research and development funding arrangements in recent years, and we may make additional acquisitions, divestitures, and arrangements in the future. Our integration of the operations of any acquired businesses, or a divestiture of any part of our existing businesses, will require significant efforts, including the coordination of information technologies, research and development, sales and marketing, operations, manufacturing, and finance. These efforts may result in additional expenses and involve significant amounts of our management’s time that cannot then be dedicated to other projects. Our failure to manage and coordinate the growth of acquired companies successfully could also have an adverse impact on our business. Further, acquired businesses may have liabilities, or be subject to claims, litigation, or investigations, that we did not anticipate or which exceed our estimates at the time of the acquisition. In addition, we cannot be certain that the businesses we may acquire will become profitable or remain so. Factors that will affect the success of our acquisitions include:

•the presence or absence of adequate internal controls, or significant fraud in the financial systems of acquired companies;

•our ability or inability to integrate information technology systems of acquired companies in a secure and reliable manner;

•liabilities, claims, litigation, investigations, or other adverse developments relating to acquired businesses or the business practices of acquired companies, including investigations by governmental entities, potential U.S. FCPA or product liability claims, intellectual property disputes, earnout or other contingent payment disputes, or other unanticipated liabilities;

•any decrease in customer loyalty and product orders caused by dissatisfaction with the combined companies’ product lines and sales and marketing practices, including price increases;

•our ability to comply with regulatory obligations applicable to acquired companies;

•our ability to retain key employees; and

•the ability to achieve synergies among acquired companies, such as increasing sales of the integrated company’s products, achieving cost savings, and effectively combining technologies to develop new products.

We also could experience negative effects on our business, results of operations, financial condition, and cash flows from acquisition-related charges, amortization of intangible assets, and asset impairment charges.

In addition, the potential exists that expected strategic benefits from any planned or completed divestiture or third-party funding arrangement may not be realized or may take longer to realize than expected, and there can be no assurance that disputes will not arise under our third-party funding arrangements or transition service agreements that have been or may be executed as part of a divestiture. We have in the past and could in the future cancel or fail to consummate a planned acquisition, divestiture, or third-party funding arrangement, which may subject us to penalties or result in litigation.

We have recently approved and committed to a plan to terminate a third-party manufacturing agreement resulting in a pre-tax charge, and we may be required to recognize additional charges in the future, including contract write-offs and impairments to our property, plant, and equipment, goodwill, or other intangible assets, which could significantly reduce our earnings.

Under U.S. GAAP, we review certain assets, including property, plant, and equipment, goodwill, and other intangible assets, for impairment on either an annual basis or when events or circumstances occur which indicate that the carrying value of such assets might be impaired. If the review performed indicates that impairment has

occurred, we are required to record a non-cash impairment charge for the difference between the carrying value and fair value of the asset, in the period the determination is made. Additionally, when we terminate contractual arrangements, we may be required to recognize charges related to contract termination fees, write-offs of prepaid expenses or contract assets, disposal of specialized equipment or inventory associated with the terminated arrangement, and other exit costs.

The testing of assets for impairment and evaluation of contract termination costs require us to make estimates that are subject to significant assumptions about our future revenue, profitability, cash flows, fair value of assets and liabilities, weighted average cost of capital, expected contract settlement amounts, and the realizability of contract-specific assets, as well as other assumptions. Changes in these estimates, or changes in actual performance compared with these estimates, may affect the fair value of the assets or the expected costs of contract terminations, which may result in an impairment charge or additional contract-related charges. If we determine our assets are impaired in the future or incur additional costs related to contract terminations or restructurings, we may be required to record charges to earnings in our financial statements that could have a material adverse effect on our business, financial condition, results of operations, and cash flows.

We recorded a pre-tax charge of $118 million during the quarter ending January 23, 2026 related to certain of our efforts to develop high-volume automated manufacturing lines for Simplera CGMs, including contract termination costs and asset write-offs. For more information, see Note 16, “Subsequent Events,” to the unaudited condensed combined financial statements included elsewhere in this prospectus.

Legal and Regulatory Risks

We are subject to extensive and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.

Our medical devices and technologies, as well as our business activities, are subject to a complex set of regulations and rigorous enforcement, including by the U.S. FDA, U.S. Department of Justice, U.S. Department of Health and Human Services (the “U.S. HHS”) Office of the Inspector General, U.S. EPA, and numerous other federal, state, and non-U.S. governmental authorities. To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, content, marketing, and distribution of our products, as well as EHS laws and regulations. These laws and regulations are also related to fair competition, kickbacks, false claims, self-referrals, and healthcare fraud. In addition, as a manufacturer of U.S. FDA-approved devices reimbursable by federal healthcare programs, we are subject to the Physician Payments Sunshine Act, which requires us to annually report certain payments and other transfers of value we make to U.S.-licensed physicians, certain allied health professionals, and U.S. teaching hospitals. Any failure to comply with these laws and regulations could subject us or our officers and employees to criminal and civil financial penalties.

As a part of the regulatory process of obtaining marketing authorization for new products and new indications for existing products, we conduct and participate in numerous clinical trials with a variety of study designs, patient populations, and trial endpoints. Unfavorable clinical data from existing or future clinical trials may adversely impact our ability to obtain product approvals, including from the U.S. FDA, our position in, and share of, the markets in which we participate, and our business, results of operations, financial condition, and cash flows. Even if our development and clinical trial efforts appear successful to us and our regulatory submission appears satisfactory to us, the U.S. FDA or comparable international regulator may disagree and may decide not to grant marketing authorization for the products, may decide to approve the products but require narrow or less desirable labeling, or may require additional product testing or clinical trials or other data to be developed and submitted before approving the products, which would result in product launch delays and additional expense.

In addition, the ability of the U.S. FDA to review and authorize the sale of new products can be affected by a variety of factors, including government budget and funding levels, its ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory, and policy changes, and other events that may otherwise affect the U.S. FDA’s ability to perform routine functions. In particular, reductions in staff and officials at the U.S. FDA may cause delays to the agency’s ongoing review of certain products in our pipeline. Disruptions at the U.S. FDA and other agencies may also increase the time necessary for new products to be reviewed or authorized for

marketing by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the U.S. FDA, have had to furlough critical employees and stop critical activities. If a prolonged government shut-down occurs, it could significantly impact the ability of the U.S. FDA and other agencies to timely review and process our regulatory submissions, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

As a result, we cannot guarantee that we will be able to obtain or maintain marketing authorization for our new products or enhancements or modifications to existing products, and the failure to maintain approvals or obtain approval or clearance could have a material adverse effect on our business, results of operations, financial condition, and cash flows. Even if we are able to obtain approval or clearance, it may:

•take a significant amount of time;

•require the expenditure of substantial resources;

•involve stringent clinical and pre-clinical testing, as well as increased post-market surveillance;

•involve modifications, repairs, or replacements of our products; or

•limit the proposed uses of our products.

Both before and after a product is commercially released, we have ongoing responsibilities under U.S. FDA and other applicable non-U.S. governmental authority regulations. For instance, many of our facilities and procedures and those of our suppliers are also subject to periodic inspections by the U.S. FDA to assess compliance with applicable regulations. The results of these inspections can include, and have in the past included, inspectional observations on the U.S. FDA’s Form 483, warning letters, or other forms of enforcement, such as a consent decree. For example, the U.S. FDA issued a warning letter on December 9, 2021 finding that the quality system requirements at our Northridge, California facility did not conform with the U.S. FDA’s Quality System Regulation (“QSR”) with respect to our MiniMed 600 series pumps and software and remote controllers used with the Paradigm and MiniMed series pumps. In addition to the impact on our production of the MiniMed 600 series pump, our ability to progress approval of the MiniMed 780G series pump was delayed. While we have since addressed such letter to the satisfaction of the U.S. FDA, who lifted the letter in April 2023, if the U.S. FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical products are ineffective or pose an unreasonable health risk, the U.S. FDA could detain or seize adulterated or misbranded medical products, order a recall, repair, replacement, or refund of such products, refuse to grant pending pre-market approval applications or require certificates of non-U.S. governments for exports, or require us to notify HCPs and others that the products present unreasonable risks of substantial harm to the public health, and in certain rare circumstances, ban such products. The U.S. FDA and other non-U.S. government agencies may also assess civil or criminal penalties against us, our officers, or employees and impose operating restrictions on a company-wide basis. The U.S. FDA may also recommend prosecution to the U.S. Department of Justice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our products and limit our ability to obtain future pre-market clearances or approvals, and could result in a substantial modification to our business practices and operations.

Furthermore, we occasionally receive subpoenas or other requests for information from various governmental agencies around the world. While these investigations typically relate primarily to financial arrangements with HCPs, regulatory compliance, and product promotional practices, we cannot predict the timing, outcome, or impact of any such investigations. Any adverse outcome in one or more of these investigations could include the commencement of civil or criminal proceedings, substantial fines, penalties, or administrative remedies, including exclusion from government reimbursement programs and entry into Corporate Integrity Agreements (CIAs) with governmental agencies. In addition, resolution of any of these matters could involve the imposition of additional, costly compliance obligations. These potential consequences, as well as any adverse outcome from governmental investigations, could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

In addition, the U.S. FDA has taken the position that medical device manufacturers are prohibited from promoting their products other than for the uses and indications set forth in the approved product labeling, and any failure to comply could subject us to significant civil or criminal exposure, administrative obligations and costs, or other potential penalties from, or agreements with, the federal government. Our efforts to promote our products via direct-to-consumer marketing and social media initiatives may subject us to additional scrutiny of our practices of effective communication of risk information, benefits, or claims, under the oversight of the U.S. FDA, U.S. Federal Trade Commission (the “U.S. FTC”), U.S. HHS Office for Civil Rights, or others.

Governmental regulations in the United States and outside the United States are constantly changing and may become increasingly stringent. In the EU, for example, the EU Medical Device Regulation (the “EU MDR”), which became effective in May 2021, includes significant additional pre-market and post-market requirements. Penalties for regulatory non-compliance could be severe, including fines and revocation or suspension of a company’s business license, mandatory price reductions, and criminal sanctions. The development and implementation of future laws and regulations could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

We are involved in, and may in the future become involved in, litigation, arbitration, and governmental proceedings or investigations, including those stemming from third-party conduct beyond our control.

We are subject to heightened scrutiny in the healthcare industry and are involved in, or threatened with, legal, arbitration, and governmental proceedings or investigations from time to time in the ordinary course of our business, including disputes with employees, competitors, customers, suppliers, collaborators, and business partners concerning allegations of, among other things, breaches of contract, product liability, product defects, intellectual property infringement, logistics or manufacturing-related topics, quality regulations, EHS issues, termination of business relationship, and alleged or suspected violations of applicable laws in various jurisdictions. For example, in certain circumstances, insurance companies have attempted to bring private causes of action against manufacturers for making false claims. In addition, we operate in an industry characterized by extensive intellectual property litigation and, from time to time, we are subject to allegations by holders of intellectual property or proprietary rights that we are infringing, misappropriating, diluting, or otherwise violating such rights, which allegations may result in us being subject to actual or threatened lawsuits. See “—We are substantially dependent on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to our rights or the rights of others may result in our payment of significant monetary damages or royalty payments, negatively impacting our ability to sell current or future products.”

We are currently subject to ongoing and threatened lawsuits in the United States and Canada with respect to alleged personal injuries, including deaths, caused by our Series 600 insulin pumps with allegedly defective clear retainer rings that were subject to field corrective actions in 2019 and 2021: in 2019, Medtronic issued an “urgent field safety notification” directing patients to inspect the clear retainer rings on affected Series 600 insulin pumps and, in certain circumstances, offered replacement insulin pumps (which was classified as a recall by the U.S. FDA in 2020); in 2021, Medtronic expanded the recall to remove the Series 600 insulin pumps with clear retainer rings from the market. Plaintiffs have alleged that, due to a defective retainer ring, the insulin reservoir in their insulin pump could not be locked into place, causing over- or under-delivery of insulin allegedly resulting in hypoglycemia or hyperglycemia. During the six months ended October 24, 2025, we recorded a $17 million certain litigation charge in connection with certain of these pending and threatened claims and lawsuits. It is possible that the amount of our ultimate liability could materially differ from the amount currently accrued, and we are currently unable to estimate a reasonably possible loss or range of loss in excess of the amounts accrued. For additional information about these and our other current legal proceedings, see Note 14, “Commitments and Contingencies,” to the audited annual combined financial statements and Note 13, “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus.

We are not covered by insurance policies for legal proceedings related to events that occurred before the Separation Date, including the ongoing and threatened lawsuits relating to alleged personal injuries, including deaths, caused by our Series 600 insulin pumps with clear retainer rings referred to above. The outcome of any pending or potential future legal, arbitration, and governmental proceedings is difficult to predict, and excessive verdicts can occur. If such proceedings are determined adversely to us, we may be required to change our business

practices or may incur fines, penalties, or monetary losses, some of which may be significant or could disrupt our business operations. Exposure to litigation or other government action, whether directed at us, our customers, or our suppliers, or our or their respective business partners, could also divert our management’s attention and resources and adversely affect our reputation, which could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Quality problems have in the past and could in the future lead to recalls or safety alerts, product liability claims, reputational harm, adverse verdicts, or costly settlements, and could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Quality is extremely important to us and our customers due to the impact on PWD and the serious and potentially costly consequences of adverse product performance. Our business exposes us to potential product liability risks that are inherent in the design, manufacture, distribution, and marketing of medical devices. Component failures, manufacturing nonconformances, design issues, off-label use, or inadequate disclosure of product-related risks or product-related information with respect to our products have in the past and could result in the future result in an unsafe condition or injury to, or death of, a patient. These problems have in the past and could in the future lead to recall of, or issuance of a safety alert or warning letter relating to, our products.

While we have not been subject to any recent material safety alerts, recalls, warning letters, or related enforcement actions, in 2021, for example, the U.S. FDA issued a warning letter focusing on the inadequacy of specific medical device quality system requirements at our Northridge, California facility with respect to our MiniMed 600 series pumps and software and remote controllers used with the Paradigm and MiniMed series pumps. As a result, the U.S. FDA approval of our MiniMed 780G system was delayed, which led to decreased volume of patients using our AID system in fiscal year 2024 in the United States and resulted in a competitive disadvantage and fewer NPS in fiscal years 2022 and 2023 in the U.S. market leading to reduced consumables sales in fiscal year 2024. Moreover, some of our products remain subject to recalls as defined in the medical device industry, which include a range of actions, many of which do not involve product retrieval or market withdrawal, such as settings adjustments and labeling updates. For example, in 2024, we voluntarily issued a field action notifying global insulin pump customers of potential risks of shortened pump battery life with reminders on the importance of checking built-in alerts and alarms and to contact us for pump replacement if affected by this issue.

Quality problems can also lead to product liability claims and lawsuits, including class actions. For example, we are currently subject to ongoing and threatened lawsuits in the United States and Canada with respect to alleged personal injuries, including deaths, caused by our Series 600 insulin pumps with allegedly defective clear retainer rings that were subject to field corrective actions in 2019 and 2021. See Note 14, “Commitments and Contingencies,” to the audited annual combined financial statements and Note 13, “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus.

Strong product quality is critical to our success. If we fall short of these standards and our products are the subject of recalls or safety alerts, our reputation could be damaged, we could lose customers, and our revenue and results of operations could decline. Our success also can depend on our ability to manufacture to exact specification precision-engineered components, subassemblies, and finished devices from multiple materials. If our components fail to meet these standards or fail to adapt to evolving standards, our reputation, competitive advantage, and market share could be harmed. In certain situations, we may undertake a voluntary recall of products or temporarily shut down production lines based on performance relative to our own internal safety and quality monitoring and testing data.

Any of the foregoing problems, including future product liability claims or recalls, regardless of their ultimate outcome, could harm our reputation and have a material adverse effect on our business, results of operations, financial condition, and cash flows.

We are substantially dependent on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to our rights or the rights of others may result in our payment of significant monetary damages or royalty payments, negatively impacting our ability to sell current or future products.

We are substantially dependent on patent and other proprietary rights and rely on a combination of patents, trademarks, tradenames, copyrights, trade secrets, and agreements (such as employee, confidentiality, non-disclosure, and non-competition agreements) to protect our business and intellectual property. We also operate in an industry characterized by extensive intellectual property litigation. Intellectual property litigation can result in significant damages awards and injunctions that could prevent or delay our manufacture and sale of affected products or require us to pay significant royalties in order to continue to manufacture or sell affected products. We may be involved as a plaintiff or a defendant in intellectual property actions, the outcomes of which may not be known for prolonged periods of time. We have received and may in the future receive communications from holders of patents, trademarks, trade secrets, or other intellectual property or proprietary rights alleging that we are infringing, misappropriating, diluting, or otherwise violating such rights. Third parties may also claim that our owned or licensed patent rights are invalid or unenforceable. While it is not possible to predict the outcome of intellectual property litigation, it is possible that the results of such litigation could require us to pay significant monetary damages or royalty payments, negatively impact our ability to sell current or future products, require us to change our products, or that enforcement actions to protect our patent and proprietary rights against others could be unsuccessful, any of which could have a material adverse impact on our business, results of operations, financial condition, and cash flows. In addition, any public announcements related to litigation or administrative proceedings initiated or threatened against us could cause our stock price to decline.

While we intend to defend against any threats to our intellectual property, our patents, trademarks, tradenames, copyrights, trade secrets, or agreements (such as employee, confidentiality, non-disclosure, and non-competition agreements) may not adequately protect our intellectual property. Further, pending patent applications by us may not result in patents being issued to us, patents issued to or licensed by us may be challenged or circumvented by competitors, and such patents may be found invalid, unenforceable, or too limited in scope to protect our technology or provide us with any competitive advantage. In addition, our patents and those licensed by us will expire over time, our ability to protect novel business models is uncertain, and infringement may go undetected. Third parties could obtain patents that may require us to negotiate licenses to conduct our business, and such licenses may not be available on reasonable terms or at all. We may not be aware of all third-party intellectual property rights potentially relating to our current and future products. In addition, license agreements could be terminated. We also rely on non-disclosure and non-competition agreements with certain employees, consultants, and other parties to protect, in part, trade secrets and other proprietary rights. We cannot be certain that these agreements will not be breached, that such provisions will be enforceable, that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information, or that third parties will not copy or otherwise gain access to our trade secrets or proprietary knowledge. Moreover, in the United States, the U.S. FTC and various states have adopted laws and regulations that purport to ban or severely restrict the use of non-competition agreements, which may limit our ability to use and enforce non-competition agreements with employees.

In addition, the laws of certain countries in which we market or manufacture some of our products do not protect our intellectual property rights to the same extent as the laws of the United States, which could make it easier for competitors to capture market position. This may increase our vulnerability to our technology being reverse engineered or our trade secrets being compromised. If we are unable to protect our intellectual property, it could have a material adverse effect on our business, results of operations, financial condition, and cash flows. Competitors also may harm our sales by designing products that substantially mirror the capabilities of our products or technology without infringing our intellectual property rights.

We may be subject to fines, penalties, and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated.

Our marketing, promotional, and educational materials and practices are subject to the Federal Food, Drug, and Cosmetic Act of 1938, the Federal Trade Commission Act, the national law of individual EU Member States

implementing Directive 93/42 on medical devices and Directive 90/385/EEC on active implantable medical devices, and applying Regulation 2017/745 on medical devices, Directive 2006/114/EC concerning misleading and comparative advertising, and EU Directive 2005/29/EC on unfair commercial practices, and other applicable laws and regulations, each as may be amended from time to time. EU Member States’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. If the U.S. FDA, U.S. FTC, or other regulatory body with competent jurisdiction over us, our activities, or our products takes the position that our marketing, promotional, or other materials or activities constitute improper promotion or marketing of an unapproved or improper use, or that they contain untruthful, misleading, or inadequately substantiated statements or claims, such regulatory body could request that we modify our materials or practices or subject us to regulatory enforcement actions, including the issuance, depending on the regulatory body and the nature of the alleged violation, of a warning letter, injunction, seizure, civil fine, and criminal penalties.

Recent court decisions have impacted the U.S. FDA’s enforcement activity regarding off-label promotion in light of First Amendment considerations. However, there are still significant risks in this area in part due to the potential False Claims Act (“FCA”) exposure and the U.S. FDA’s continued focus on ensuring devices are marketed in a manner consistent with U.S. FDA-required labeling. Although our policy is to refrain from statements that could be considered off-label promotion of our products or pre-promotion of an unapproved product, the U.S. FDA, U.S. FTC, or other regulatory authority could disagree and conclude that we have engaged in improper promotional activities. In addition, the off-label use of our products may increase the risk of product liability claims, which are expensive to defend and could result in substantial damage awards against us and harm our reputation.

Healthcare policy changes may have a material adverse effect on us.

There have been and continue to be actions and proposals by several governments, regulators, and third-party payors globally, including the U.S. federal and state governments and the government in China, to control healthcare costs, and, more generally, to reform healthcare systems. Certain of these actions and proposals, among other things, limit the prices we are able to charge for our products or the amounts of reimbursement available for our products, increase the importance of our ability to compete on cost, and could limit the acceptance and availability of our products. These actions and proposals could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our revenue may be limited by the continuing efforts of government and third-party payors to contain or reduce the costs of healthcare through various increasingly sophisticated means, such as leveraging increased competition, increasing eligibility requirements such as second opinions and other documentation, purchasing in a bundle, or redesigning benefits. The continuing efforts of government and private third-party payors to reduce healthcare costs could also lead to PWD being unable to obtain approval for payment from these third-party payors.

We rely on the proper function, security, and availability of our information technology systems and data, as well as those of third parties throughout our global supply chain and our customer and payor base, to operate our business, and a breach, cyber-attack, or other disruption to these systems or data, which we have experienced and may experience again in the future, could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.

We are increasingly dependent on sophisticated information technology systems to operate our business. That technology includes systems that could be used to process, transmit, and store sensitive data. Additionally, many of our products and services include integrated software and information technology that collects data regarding PWD or connects to other internal systems. One of the most prevalent attacks on large organizations has been ransomware, which can have a devastating impact on an organization’s operations. Our ransomware readiness program has required and will continue to require investment and will not guarantee that we will be immune from an incident or be able to respond rapidly enough to prevent a negative impact on our business. Like all organizations, we routinely experience attempted interference with the integrity of, and interruptions in, our technology systems via events such as cyber-attacks, malicious intrusions, service interruptions, or other breakdowns. Our information technology systems have been and may also in the future be vulnerable to inadvertent or intentional actions by our employees, third-party vendors, or other third parties with whom we do business. We have experienced these types of incidents which have led to data breaches, and any such incidents that we may experience in the future could lead to

additional data breaches, interference with the integrity of our products and data, compromise of intellectual property or other proprietary information, or other significant disruptions.

We may not be able to anticipate all types of security threats, and we may not be able to implement preventive measures effective against all such security threats. Furthermore, we rely on third-party vendors to supply or support certain aspects of our information technology systems and resulting products, and customers and payors use information technology systems to process payments relating to our products and services. These third-party systems could also become vulnerable to cyber-attack, malicious intrusions, breakdowns, interference, or other significant disruptions, and may contain defects in design or manufacture or other problems that could result in system disruption or compromise the information security of our own systems. If any of the foregoing occurs, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event.

We continue to grow in part through new business acquisitions and, as a result, may face risks associated with defects and vulnerabilities in acquired businesses’ systems, or difficulties or other breakdowns or disruptions in connection with the integration of such acquisitions into our information technology systems. The costs related to significant security breaches or disruptions could be material and cause us to incur significant expenses, and any cybersecurity insurance that we may have in place may not cover such expenses.

Our global profile and international operations expose us to geopolitical events or issues which may increase cybersecurity risks on a global basis. Our worldwide operations also mean that we are subject to laws and regulations, including data protection and cybersecurity laws and regulations, in many jurisdictions. The variety of U.S. and international privacy and cybersecurity laws and regulations impacting our operations are described in “—We are subject to stringent and often unsettled privacy laws, regulations, policies, and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, and contractual obligations could adversely affect our business.” and “Business—Government Regulation and Product Approval Process—Data Privacy and Security Laws.” Any data security breaches, cyber-attacks, malicious intrusions, or significant disruptions could result in actions by regulatory bodies or civil litigation, any of which could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.

Our information technology systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems. We experience continuing changes in information processing technology, legal and regulatory standards, patient and customer information use cases, techniques used to obtain unauthorized access to data and information systems, and the information technology needs associated with our changing products and services. We also face business and regulatory risks relating to our use of AI systems in our business operations and products. These systems are susceptible to flaws, biases, malfunctions, or manipulations, which may disrupt our operations, result in erroneous decision-making, elevate our cyber risk profile, or expose us to penalties from non-compliance with emerging regulations. There can be no assurance that our efforts to keep pace with continuing changes in information processing technologies, including AI systems, and to deploy these technologies to our business operations and products will be successful or that additional systems issues will not arise in the future.

Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of HCPs to treat PWD and PWD to manage their conditions. These same features may also increase cybersecurity risks and the risks of unauthorized access and use by third parties. As such, a cyber-attack which intrudes, disrupts, or corrupts our devices, products, and services or related devices, products, and services could impact the quality of care PWD receive or the confidentiality of patient information. Additionally, modifying or using any such devices, products, or services in a way inconsistent with our U.S. FDA clearances and approvals may create risks to users and potential exposure to us.

If our information technology systems, products, or services, or those of our third-party vendors, or our sensitive data are compromised, there are many consequences that could result. Consequences include, but are not limited to:

•customers or employees being exposed to financial or medical identity theft or suffering a loss of product functionality;

•losing existing customers or having difficulty attracting new customers;

•experiencing difficulty preventing, detecting, and controlling fraud;

•being exposed to the loss or misuse of confidential information;

•having disputes with PWD, physicians, and other HCPs;

•suffering regulatory sanctions or penalties under U.S. federal laws, state laws, or the laws of other jurisdictions;

•experiencing increases in operating expenses or an impairment in our ability to conduct our operations;

•incurring expenses or losing revenue as a result of a data privacy breach;

•product failure;

•information technology outages or disruptions; and

•suffering other adverse consequences including lawsuits or other legal action and damage to our reputation.

We are subject to stringent and often unsettled privacy laws, regulations, policies, and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, and contractual obligations could adversely affect our business.

We are subject to evolving data privacy and protection laws and regulations that apply to the collection, transmission, storage, and use of personally identifying information or personal data. See “Business—Government Regulation and Product Approval Process—Data Privacy and Security Laws.” Determining whether such information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation. The global nature of our business necessitates compliance with privacy regimes around the globe.

In particular, regulations promulgated pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”) establish privacy and security standards that limit the use and disclosure of personally identifiable health information, or protected health information, and require the implementation of additional administrative, physical, and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity, and availability of electronic protected health information. If we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts. Further, if we fail to comply with applicable privacy laws, including applicable HIPAA privacy and security standards, we could face significant administrative, civil, and criminal penalties.

In the United States, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act and its regulations (collectively, the “CCPA”), requires companies that process information on California residents to make disclosures to consumers about their data collection, use, and sharing practices, allows consumers to opt out of certain data sharing with third parties, provides a new private right of action for certain data breaches, and creates a state agency that is vested with authority to implement and enforce the CCPA. Several other U.S. states have enacted or proposed their own data privacy laws, and it is expected that other states will enact their own laws. Moreover, all 50 U.S. states and the District of Columbia have enacted breach notification laws that may require us to notify patients, employees, or regulators in the event of unauthorized access to or disclosure of personal or confidential information experienced by us or our service providers. New legislation proposed or enacted in various

other states will continue to shape the data privacy environment nationally, and such laws may differ from each other, which may complicate compliance efforts.

In Europe, we are subject to the EU’s General Data Protection Regulation (the “EU GDPR”), as well as the UK General Data Protection Regulation and the UK Data Protection Act 2018 (collectively, the “UK GDPR”), which currently imposes the same obligations as the EU GDPR in most material respects. The EU GDPR and the UK GDPR impose strict rules on the processing of personal information and transfers of personal information to countries outside of the European Union/European Economic Area (the “EU/EEA”) and the United Kingdom, respectively. As the enforcement landscape develops and supervisory authorities issue further guidance on international data transfers, we could suffer additional costs, complaints, or regulatory investigations or fines, we may have to make certain operational changes, and we may have to implement revised transfer mechanisms within required time frames.

Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials, public censure, claims for damages by affected individuals, damage to our reputation, and loss of goodwill, any of which could adversely affect our business, results of operations, financial condition, cash flows, reputation, or competitive position.

The failure to comply with anti-corruption laws could materially adversely affect our business and result in civil or criminal sanctions.

The U.S. FCPA and similar anti-corruption laws in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to government officials for the purpose of obtaining or retaining business and to ensure adequate internal controls, books, and records. Because of the predominance of government-administered healthcare systems in many jurisdictions around the world, many of our customer relationships outside of the United States are with governmental entities and are therefore potentially subject to such laws. We also participate in public-private partnerships and other commercial and policy arrangements with governments around the globe.

Global enforcement of anti-corruption laws has increased in recent years, including investigations and enforcement proceedings leading to assessment of significant fines and penalties against companies and individuals. Our international operations create a risk of unauthorized payments or offers of payments by one of our employees, consultants, sales agents, or distributors. We maintain various controls aligned with legal requirements to prevent and prohibit improper practices, including policies, programs, and training for our employees and third-party intermediaries acting on our behalf. However, existing safeguards and any future improvements may not always be effective, and our employees, consultants, sales agents, or distributors may engage in conduct for which we could be held responsible. In addition, regulators could seek to hold us liable for conduct committed by companies in which we invest or that we acquire. Any alleged or actual violations of these regulations may subject us to government scrutiny, criminal or civil sanctions, and other liabilities, including exclusion from government contracting, and could disrupt our business, adversely affect our reputation, and result in a material adverse effect on our business, results of operations, financial condition, and cash flows.

Laws and regulations governing international business operations could adversely impact our business.

The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the U.S. Commerce Department’s Bureau of Industry and Security (BIS) administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons from conducting activities in, transacting business with, or making investments in certain countries, governments, entities, and individuals subject to U.S. economic sanctions or export restrictions. Our international operations subject us to these laws and regulations, which are complex, restrict our business dealings with certain countries, governments, entities, and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced, or interpreted in a manner that materially impacts our operations.

From time to time, we have limited business dealings in countries subject to comprehensive sanctions, including Iran, Cuba, and the region of Crimea, as well as Russia and Belarus. Certain of our subsidiaries sell medical devices, and may provide related services, to distributors and other purchasing bodies in such countries or regions. These business dealings represent an insignificant amount of our consolidated revenues and income but expose us to a

heightened risk of violating applicable sanctions regulations. Violations of these regulations are punishable by civil penalties, including fines, denial of export privileges, injunctions, asset seizures, debarment from government contracts, and revocations or restrictions of licenses, as well as criminal fines and imprisonment. We have established policies and procedures designed to assist with our compliance with such laws and regulations. However, such regulations may impact our ability to continue operations in certain countries and require additional licenses which we may not be able to obtain or maintain. There can be no assurance that our policies and procedures will prevent us from violating these regulations in every transaction in which we may engage, and such a violation could adversely affect our reputation, business, results of operations, financial condition, and cash flows.

Climate change, or legal, regulatory, or market measures to address climate change, may materially adversely affect our financial condition and business operations.

Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere presents risks to our current and future operations. We face current and long-term operational risks and have in the past experienced business interruptions from severe weather events and other natural and man-made conditions, such as hurricanes, tornadoes, droughts, extreme temperatures, wildfires, or flooding. Such severe weather events caused by or related to climate change or other conditions caused by natural or man-made disasters have in the past and could in the future increase our operational costs, pose physical risks to our facilities, and adversely impact our supply chain, including manufacturing and distribution networks, the availability and cost of raw materials and components, and energy supply, transportation, or other inputs necessary for the operation of our business. The impacts of climate change on global water resources may result in water scarcity, which could impact our ability to access sufficient quantities of water in certain locations and result in increased costs. Although it is difficult to predict and adequately prepare to meet the challenges to our business posed by climate change, concerns over climate change have resulted and could result in new laws or regulations that are more stringent. For example, in October 2023, California enacted various laws that will require companies that do business in California and meet certain financial thresholds to publicly disclose their Scope 1, 2, and 3 greenhouse gas emissions and issue public reports on their climate-related financial risk and related mitigation measures. As a result of these and other climate-related laws or requirements, we may experience increased compliance burdens and costs to meet the regulatory obligations, as well as adverse impacts on raw material sourcing, manufacturing operations, and the distribution of our products. While there have been a series of proposals and changes at the U.S. federal and state level to revise programs related to climate change and other environmental rules and regulations, we cannot predict at this time the extent of future changes to such programs, laws, or regulations, the outcome such revisions will have on the climate change and environmental regulatory landscape, or the ultimate impact on our business.

We are subject to EHS laws and regulations and the risk of environmental liabilities, violations, and litigation.

We are subject to EHS laws and regulations, as enforced by international, federal, state, and local authorities, including the U.S. EPA, U.S. Occupational Health and Safety Administration, and analogous state agencies, concerning, among other things: the generation, handling, transportation, storage, and disposal of hazardous substances or wastes; human health and safety; the remediation of hazardous substances or materials; and emissions or discharges into the land, air, or water. Under certain environmental laws, we could be subject to strict, joint, and several liability for investigating and remediating contamination at properties we currently or formerly owned, leased, or operated, or at third-party sites to which we sent wastes. We are further subject to numerous laws and regulations concerning, among other things, chemical constituents in medical products and end-of-life disposal and take-back programs for medical devices. Our operations and those of certain of our third-party suppliers involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes. If we or our suppliers violate any EHS laws and regulations, violators could be fined or otherwise sanctioned, and in extraordinary situations, facilities could be shut down. New laws and regulations, violations of these laws or regulations, stricter enforcement of existing requirements, or the discovery of previously unknown contamination could require us to incur costs or become the basis for new or increased liabilities or other risks that could be material.

In particular, many regulatory agencies in the United States and internationally are imposing new and evolving regulatory requirements on the safe use of certain chemicals which may be contained in our products or used during the manufacturing or sterilization processes, including EtO and per- and polyfluoroalkyl substances (“PFAS”), and

evaluating their potential impact on health and the environment. We are actively working with suppliers to evaluate the use or presence of PFAS and the use of EtO for sterilization in our products or manufacturing processes to help ensure compliance with such requirements. These and other global regulatory developments may require us to take additional actions, including investigation, remediation, and compliance actions, may result in additional litigation and enforcement actions or increase our costs, or could trigger additional community concerns or other reputational risks.

We are subject to risks related to sustainability practices and initiatives.

There is continued focus from our stakeholders, as well as regulatory authorities in the United States, EU, and other global jurisdictions in which we operate, on sustainability practices and disclosure. Stakeholders’ expectations are not uniform, and proponents and opponents of various sustainability-related matters have increasingly resulted in a range of activism and legal and regulatory developments. If we do not succeed in meeting, or are perceived as not meeting, stakeholders’ expectations, whether in support of or against sustainability-related matters, or stated sustainability goals and objectives, such as environmental stewardship, inclusion initiatives, supply chain practices, good corporate governance, workplace conduct, and support for local communities, or if we do not effectively respond to new or revised legal, regulatory, or reporting requirements concerning sustainability-related matters, including climate change or other sustainability concerns, we may be subject to enforcement actions, litigation risks, regulatory fines and penalties, or other sanctions, our reputation or the reputation of our brands may suffer, we may be unable to attract and retain top talent, and our stock price may be negatively affected, among other things.

Enhanced or conflicting sustainability-related laws, regulations, and expectations in and across the jurisdictions in which we do business may increase compliance burdens and costs for us and for third parties throughout our global supply chain, which could cause disruption in the sourcing, manufacturing, and distribution of our products and adversely affect our business, results of operations, financial condition, and cash flows. Notably, we will be subject to sustainability reporting requirements imposed by the EU’s Corporate Sustainability Reporting Directive (the “CSRD”). The CSRD requires a “double materiality” analysis, which means that companies will have to report on how sustainability issues might create financial risks for them and on their own impacts on people and the environment. While we cannot predict the outcome of any future modifications to the CSRD, due to our EU operations, we believe the CSRD currently will apply to us for fiscal year 2028 reporting, which will require us to disclose a range of sustainability-related matters. Reporting on sustainability goals and objectives may cause us to expend significant capital and human resources, and could divert our management’s attention from operating and growing our business. Reports could also lead to the disclosure of information which may have a negative impact on our operations and reputation or attract negative scrutiny. Failure to accurately comply with any sustainability reporting obligations may result in enforcement actions, sanctions, reputational harm, or private litigation, among other things.

Changes in tax laws, adverse outcomes resulting from examination of our tax returns, or other exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition, and cash flows.

The tax laws in the United States and other countries in which we and our affiliates do business could change on a prospective or retroactive basis, and any such changes could have a material impact on our business, results of operations, financial condition, and cash flows.

The Organization for Economic Co-operation and Development (OECD) has published Pillar Two Model Rules defining the global minimum tax, which calls for the taxation of large multinational corporations at a minimum rate of 15% in each jurisdiction in which the group operates. The OECD has since issued administrative guidance providing transition and safe harbor rules around the implementation of the Pillar Two Model Rules. A number of countries in which we and our subsidiaries operate have enacted legislation to implement the core elements of the Pillar Two Model Rules, and the application of these rules in any of the jurisdictions may impact the financial results of us or our subsidiaries.

We are subject to ongoing tax audits in the various jurisdictions in which we operate. Tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the likely outcomes of

these audits in order to determine the appropriateness of our tax provision. However, there can be no assurance that we will accurately predict the outcomes of these audits, and the actual outcomes of these audits could have a material impact on our business, results of operations, financial condition, and cash flows.

We have recorded reserves for potential payments of tax to various tax authorities related to uncertain tax positions. However, the calculation of such tax liabilities involves the application of complex tax laws, regulations, and treaties (where applicable) in many jurisdictions. Therefore, any dispute with a tax authority may result in a payment that is significantly different from current estimates. If payment of these amounts ultimately proves to be less than the recorded amounts, the reversal of the liabilities generally would result in tax benefits being recognized in the period when we determine the liabilities are no longer necessary. If our estimate of tax liabilities proves to be less than the amount for which it is ultimately liable, we would incur additional charges, and such charges could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our ability to use our net operating losses (“NOLs”) to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.

Our ability to use our NOLs to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability. In addition, realization of deferred tax assets, including net operating loss carryforwards, depends upon our future earnings in applicable tax jurisdictions. If we have insufficient future taxable income in the applicable tax jurisdiction for any reason, including any future corporate reorganization or restructuring activities, we may be limited in our ability to utilize some or all of our NOLs to offset such income and reduce our tax liability in that jurisdiction. There is also a risk that due to regulatory changes or changes to the laws in the jurisdictions in which we operate, such as suspensions on the use of NOLs or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable either in whole or in part to offset future income tax liabilities.

Risks Related to the Separation and the Divestment

We have a limited history of operating as a standalone public company, and our historical and pro forma financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.

Since 2001, we have operated as part of Medtronic. The financial information included in this prospectus has been prepared from Medtronic’s historical accounting records and is derived from the consolidated financial statements of Medtronic to present the Diabetes Operating Unit as if it had been operating on a standalone basis. Accordingly, this information may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during the periods presented or what our financial condition, results of operations, and cash flows may be in the future, primarily because of the following factors:

•Prior to the Separation, our business has been operated by Medtronic as part of its broader corporate organization, rather than as an independent company. Medtronic or one of its affiliates performed various corporate functions for us, such as tax, legal, information technology, treasury, accounting, internal auditing, human resources, investor relations, risk management, regulatory, compliance, insurance, finance, regional sales and marketing, customer care, quality, operations, demand and supply planning, procurement, warehousing, distribution, real estate, and EHS functions. Following the Separation and the Divestment, Medtronic will continue to provide some of these functions to us as we complete our transition to an independent, publicly traded company. See “Certain Relationships and Related Person Transactions.” Our historical and pro forma financial results reflect allocations of corporate expenses from Medtronic for such functions, which may be less than the expenses we would have incurred had we operated as a separate, publicly traded company. We will need to make significant investments to replicate or outsource from other providers certain facilities, systems, infrastructure, and personnel to which we will no longer have access once the terms of our arrangements with Medtronic expire. These initiatives to develop our independent ability to operate without access to Medtronic’s existing operational, administrative, information technology, and systems infrastructure will be costly to implement, and we will incur additive costs in implementing such initiatives currently provided to us by Medtronic. In addition, we may be unable to

obtain replacement services on similar terms as those provided by Medtronic. We may not be able to operate our business as efficiently or at comparable costs, and our results of operations may be adversely affected.

•Currently, our business is integrated with the other businesses of Medtronic. Historically, we have been able to utilize Medtronic’s overall size and scope in procuring various goods and services and have shared economies of scope and scale in costs, employees, vendor relationships, and customer relationships. Although we will enter into transition agreements with Medtronic, these arrangements may not fully capture the benefits we have enjoyed as a result of being integrated with Medtronic. As a separate, independent company, we may be unable to obtain goods and services at the prices and terms that Medtronic obtained prior to the Separation, which could adversely affect our results of operations. After the completion of the Separation, the cost of capital for our business may be higher than Medtronic’s cost of capital prior to the Separation.

•Our historical and pro forma financial results reflect the direct and indirect costs for the services historically provided by Medtronic to us. Following the completion of this offering, Medtronic will continue to provide some of these services to us on a transitional basis pursuant to the Transition Services Agreement and other transitional agreements. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation.” Our historical financial information does not reflect our obligations under the various transitional agreements we will enter into with Medtronic in connection with the Separation. At the end of the transitional periods specified in these agreements, we will need to perform these functions ourselves or hire third parties to perform these functions on our behalf, and these costs may significantly exceed the comparable expenses we have incurred in the past.

•Our working capital requirements and capital expenditures have historically been satisfied as part of Medtronic’s corporate-wide cash management and centralized funding programs, and our cost of capital may differ significantly from the historical amounts reflected in our historical financial statements.

•As an independent public company, we will separately become subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), and the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) and will be required to prepare standalone financial statements according to the rules and regulations required by the Securities and Exchange Commission (the “SEC”). See “—Risks Related to the Separation and Divestment—Our accounting, tax, and other management systems and resources may not be adequately prepared to meet the independent financial reporting, transparency, and other requirements to which we will be subject as a standalone, publicly traded company following the Separation.”

Other significant changes may occur in our cost structure, management, financing, and business operations as a result of operating as a company separate from Medtronic. For additional information about the past financial performance of our business and the basis of presentation of the historical combined financial statements and the unaudited pro forma combined financial statements of our business, see “About this Prospectus—Basis of Presentation,” “Unaudited Pro Forma Condensed Combined Financial Statements,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and the historical financial statements and accompanying notes included elsewhere in this prospectus.

Our unaudited pro forma condensed combined financial statements included in this prospectus have been presented for illustrative and informational purposes only. The unaudited pro forma condensed combined financial data may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during the periods presented. In addition, the unaudited pro forma condensed combined financial data may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future. The unaudited pro forma condensed combined financial data is based upon available information and assumptions that we believe are reasonable and supportable. Actual results, however, may vary.

Following the Separation and the Divestment, our financial profile will change, and we will be a smaller, less diversified company than Medtronic prior to the Separation.

The Separation will result in each of Medtronic and the Company being smaller, less diversified companies with more limited businesses concentrated in their respective industries. As a result, we may be more vulnerable to changing market conditions, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows. In addition, the diversification of our revenues, costs, and cash flows will diminish as a standalone company, such that our results of operations, cash flows, working capital, and financing requirements may be subject to increased volatility and, because we will no longer be able to use cash flow from Medtronic to fund our investments and operations, our ability to fund capital expenditures and investments, pay dividends, if any, and service debt may be diminished.

We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, results of operations, financial condition, and cash flows.

We may not be able to achieve the full strategic and financial benefits expected to result from the Separation, or such benefits may be delayed or not occur at all. The Separation is expected to provide a number of benefits, including those described elsewhere in this prospectus.

We may not achieve these and other anticipated benefits for a variety of reasons, including, among others:

•the Separation will demand significant management resources and require significant amounts of our management’s time and effort, which may divert our management’s attention from operating and growing our business;

•we may experience employee turnover or attrition in connection with the Separation;

•following the Separation, we may be more susceptible to market fluctuations and other adverse events than if we were still a part of Medtronic because our business will be less diversified than Medtronic’s business prior to the completion of the Separation;

•after the Separation, as a standalone company, we may be unable to obtain certain goods, services, and technologies, or obtain them at prices or on terms as favorable as those Medtronic obtained prior to completion of the Separation;

•in connection with the Separation and transition to being a standalone public company, we will incur costs that will, in the aggregate, be substantial, and these costs may include accounting, tax, legal, and other professional services costs, recruiting and relocation costs associated with hiring key senior management and personnel new to the Company, tax costs, costs to separate information systems and establish an independent manufacturing footprint and distribution network, costs to establish our own real estate footprint, costs of negotiating our own contracts, costs to rebrand and relabel, and costs of developing an independent ability to operate without access to Medtronic’s existing operational, administrative, information technology, and systems infrastructure;

•to preserve the generally tax-free treatment for U.S. federal income tax purposes to Medtronic of certain steps of the Separation and the Divestment, if pursued, our ability to pursue certain strategic transactions may be restricted; and

•other actions required to separate the respective businesses could disrupt our operations.

If we fail to achieve some or all of the benefits expected to result from the Separation, if such benefits are delayed, or if the anticipated structure of the Separation were to change, it could have a material adverse effect on our competitive position, business, financial condition, results of operations, and cash flows.

Medtronic’s plan to separate the Diabetes Operating Unit into an independent, publicly traded company is subject to various risks and uncertainties and may not be completed in accordance with the expected plans or anticipated timeline, or at all, and will involve significant time and expense, which could disrupt or adversely affect our business.

Medtronic’s separation of the Diabetes Operating Unit into an independent, publicly traded company is complex in nature, and unanticipated developments or changes, including changes in the law, the macroeconomic environment, competitive conditions of Medtronic’s markets, regulatory approvals or clearances, the uncertainty of the financial markets, and challenges in executing the Separation, could delay or prevent the completion of the proposed Separation, result in changes to the anticipated structure and manner of the Separation, or cause the Separation to occur on terms or conditions that are different or less favorable to us than expected. Additionally, the Medtronic board of directors, in its sole and absolute discretion, may decide not to proceed with the Divestment, on the terms and in the manner then disclosed or at all, at any time prior to the date of the Divestment or if no Divestment has occurred, the date that Medtronic ceases to control us (the “Divestment Date”).

The process of completing the Separation has been and is expected to continue to be time-consuming and involves significant costs and expenses. The Separation costs may be significantly higher than what we currently anticipate and may not yield a discernible benefit if the Separation is not completed or is not well executed, or the expected benefits of the Separation are not realized. Executing the Separation will also require significant amounts of our management’s time and effort, which may divert our management’s attention from operating and growing our business. Other challenges and potential costs associated with effectively executing the Separation include attracting, retaining, and motivating employees during the pendency of the Separation and following its completion; addressing disruptions to our supply chain, manufacturing, sales and distribution, and other operations resulting from separating the Diabetes Operating Unit into an independent, publicly traded company; separating Medtronic’s information systems; and developing an independent ability to operate without access to Medtronic’s existing operational, administrative, information technology, and systems infrastructure.

We could experience temporary interruptions in business operations and incur substantial additional costs as we build our information technology infrastructure and transition our data to our own systems.

We will engage in the process of either creating our own or engaging third parties to provide information technology infrastructure and systems to support our critical business functions, including accounting and reporting, manufacturing process control, quality and compliance systems, sales, invoicing, customer service, inventory control, and distribution, in order to replace many of the systems Medtronic currently provides to us. We may incur temporary interruptions in business operations if we cannot transition effectively from Medtronic’s existing transactional and operational systems, data centers, databases, programming languages, and the transition services that support these functions as we replace these systems. We may not be successful in implementing our new systems and transitioning our data, and we may incur substantially higher costs for implementation than currently anticipated. Our failure to avoid operational interruptions as we implement the new systems, transition our data, and replace Medtronic’s information technology services, or our failure to implement the new systems, transition our data, and replace Medtronic’s services successfully and cost-effectively, could disrupt our business operations or have a material adverse effect on our profitability. If we are unable to replicate or transition certain systems, our ability to comply with regulatory requirements could be impaired. In addition, our costs for the operation of these systems may be higher than the amounts reflected in our historical combined financial statements.

Our accounting, tax, and other management systems and resources may not be adequately prepared to meet the independent financial reporting, transparency, and other requirements to which we will be subject as a standalone, publicly traded company following the Separation.

Our financial results previously were included within the consolidated results of Medtronic, and we believe that our reporting and control systems were appropriate for those of subsidiaries of a public company. However, we were not directly subject to the reporting and other requirements of the Exchange Act. As a result of the Separation, we will be directly subject to reporting and other obligations under the Exchange Act, including the requirements of Section 404 of the Sarbanes-Oxley Act, which will require annual management assessments of the effectiveness of our internal control over financial reporting and a report by our independent registered public accounting firm

addressing these assessments beginning with our second annual report on Form 10-K. These reporting and other obligations will place significant demands on our management and our administrative and operational resources, including accounting resources. We may not have sufficient time following the Separation to meet these obligations by the applicable deadlines.

Moreover, to comply with these requirements, we anticipate that we will need to migrate our systems, including information technology systems, to the Company, implement additional financial and management controls, reporting systems, and procedures, and hire additional accounting, legal, tax, and finance staff. We expect to incur additional annual expenses related to these steps, and those expenses may be significant. If we are unable to implement our financial and management controls, reporting systems, information technology, and procedures in a timely and effective fashion, our ability to comply with our financial reporting requirements and other rules that apply to reporting companies under the Exchange Act could be impaired. In the event we are unable to implement a sufficient tax reporting system and related processes, we may be unable to comply with tax law and face penalties associated with our lack of compliance. Any failure to achieve and maintain effective internal controls could result in adverse regulatory consequences or loss of investor confidence, which could limit our ability to access the global capital markets and could have a material adverse effect on our business, financial condition, results of operations, cash flows, or the market price of our securities.

In connection with the Separation, we may be required to indemnify Medtronic for certain liabilities, Medtronic’s indemnities to us may be insufficient, and we will have very limited access to Medtronic’s insurance and will be essentially uninsured for many types of claims related to events that occurred before the Separation.

Pursuant to the Separation Agreement and certain other agreements between us and Medtronic, each party will agree to indemnify the other for certain liabilities, in each case for potentially uncapped amounts, as discussed further in the section entitled “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Separation Agreement” of this prospectus. Indemnities that we may be required to provide Medtronic are not subject to any cap, may be significant, and could negatively impact our business. Third parties could also seek to hold us responsible for any of the liabilities that Medtronic has agreed to retain. Any amounts we are required to pay pursuant to these indemnification obligations and other liabilities could require us to divert cash that would otherwise have been used in furtherance of operating our business. Further, the indemnities from Medtronic for our benefit may not be sufficient to protect us against the full amount of such liabilities, and Medtronic may not be able to fully satisfy its indemnification obligations.

In addition, pursuant to the Separation Agreement, Medtronic intends to remove us, and our respective employees, officers, and directors, as insured parties under Medtronic’s insurance policies (self-funded or otherwise) immediately prior to the Separation date. From and after the Separation date, we will not have access to, or the right to make claims under, Medtronic’s insurance policies for any facts, circumstances, events, or matters occurring on or after the Separation date. While we may assert certain claims under Medtronic’s insurance policies for liabilities associated with occurrences prior to the Separation, such coverage is very limited as Medtronic self-insures most of its insurable risks. Any limited coverage available to us is subject to Medtronic’s primary control over such claims and the terms and conditions of the relevant insurance policies and may be denied by Medtronic’s insurers. Consequently, we will be uninsured for most types of claims related to our business that arose prior to the Separation, including claims related to product liability, intellectual property disputes, cybersecurity, privacy, commercial disputes, employment matters, and government investigations. Furthermore, following the Separation, we will need to obtain our own insurance coverage, which may be costly or difficult to obtain on favorable terms, and we may be exposed to significant uninsured liabilities for any claims that arose prior to the completion of this offering. Each of the foregoing risks could negatively affect our business, results of operations, financial condition, and cash flows.

Medtronic may fail to perform under various transaction agreements that will be executed as part of the Separation, or we may fail to have necessary infrastructure, systems, and services in place when certain of the transaction agreements expire.

In connection with the Separation, we and Medtronic will enter into the Separation Agreement and various other agreements, including the Tax Matters Agreement, the Employee Matters Agreement, the Intellectual Property

Cross-License Agreements, the Transitional Trademark Cross-License Agreement, the Trademark Co-Existence Agreement, the Transition Services Agreement, the Registration Rights Agreement, the Juncos Lease and Services Agreements, and the Transition Manufacturing Agreements. These agreements, together with the documents and agreements by which the internal reorganization of the Diabetes Operating Unit will be effected by Medtronic, will determine the allocation of assets and liabilities between the companies following the Separation for those respective areas and will include any necessary indemnifications related to liabilities and obligations. Certain of these agreements will also provide for the performance of services by each company for the benefit of the other for a period of time after the Separation. We will rely on Medtronic to satisfy its performance and payment obligations under these agreements. If Medtronic is unable or unwilling to satisfy its obligations under these agreements, including its indemnification obligations, we could incur operational difficulties or losses. These agreements are discussed in greater detail in the section entitled “Certain Relationships and Related Person Transactions.”

If we do not have in place our own systems and services, or if we do not have agreements with other providers of these services once certain transitional transaction agreements expire, we may not be able to operate our business effectively, and our profitability may decline. We are in the process of creating our own, or engaging third parties to provide, systems and services to replace many of the systems and services that Medtronic currently provides to us. However, we may not be successful in implementing these systems and services in a timely manner or at all, we may incur additional costs in connection with, or following, the implementation of these systems and services, and we may not be successful in transitioning data from Medtronic’s systems to ours. These systems and services may also be more expensive or less efficient than the systems and services Medtronic is expected to provide during the transition period.

We may be held liable to Medtronic if we fail to perform certain services or supply obligations under the Transition Services Agreement, and the performance of such services or supply obligations may negatively impact our business and operations.

In connection with the Separation, we and Medtronic will enter into various agreements, including a Transition Services Agreement, that will provide for the performance of certain services and the supply of certain products by us for the benefit of Medtronic for a period of time after the Separation. If we do not satisfactorily perform our obligations under these agreements, we may be held liable for any resulting losses suffered by Medtronic, subject to certain limits. In addition, during the transition services period, our management and employees may be required to divert their attention away from our business in order to provide services to Medtronic or manage aspects of the transition agreements between us and Medtronic, which could adversely affect our business.

We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with Medtronic.

The agreements we will enter into with Medtronic in connection with the Separation, including the Separation Agreement, the Tax Matters Agreement, the Employee Matters Agreement, the Intellectual Property Cross-License Agreements, the Transitional Trademark Cross-License Agreement, the Trademark Co-Existence Agreement, the Transition Services Agreement, the Registration Rights Agreement, the Juncos Lease and Services Agreements, and the Transition Manufacturing and Supply Agreement were prepared in the context of the Separation while our business was still operated by and as part of Medtronic. Accordingly, during the period in which these agreements were prepared, we did not have a separate or independent board of directors or a management team that was separate from or independent of Medtronic. The terms of these agreements, including the fees charged for services provided under these agreements, were primarily determined by Medtronic and, as a result, may not necessarily reflect terms that would have resulted from arm’s-length negotiations between unaffiliated third parties or from arm’s-length negotiations between Medtronic and an unaffiliated third party in another form of transaction, such as a buyer in a sale of a business transaction. See “Certain Relationships and Related Person Transactions.”

Under the terms of the Separation, our ability to manage our manufacturing operations will be restricted under the terms of the Juncos Lease and Services Agreements and the Tax Matters Agreement, and we therefore may not be able to fully conduct these operations in a manner that is optimal for our business.

Our Juncos facility currently manufactures products representing the majority of our revenue. Following the Separation, Medtronic will lease a portion of the Juncos facility from us so it may continue to manufacture certain of its products at the facility. The term of the lease will be up to ten years if Medtronic fully exercises its renewal options. During the term of the lease, we will not be able to utilize all of the facility’s current manufacturing capacity to support our business. In addition, the terms of the lease will require us to devote time and resources to fulfill our obligations as a landlord, including obligations to maintain the facility’s structural elements and systems that serve Medtronic’s production operations, ensure adequate utility capacity exists for Medtronic’s portion of the facility, segregate areas used by our and Medtronic’s production operations to ensure our operations do not interfere with Medtronic’s operations, and maintain common and shares access areas. We may also be subject to EHS or other risks or liabilities related to Medtronic’s production operations to which we would not otherwise be subject, and the remediation of any quality audit findings related to Medtronic’s production operations may create obligations for us to which we would not otherwise be subject. Furthermore, during the term of the lease we will be prohibited without Medtronic’s consent from assigning our interest in the lease to a third party which could, among other things, limit our ability to sell the facility. In addition, in order to preserve the intended Puerto Rican tax treatment with respect to the Separation and Divestment, we will enter into the Tax Matters Agreement that, among other things, will require us to maintain a minimum head count and level of operations at the Juncos facility for a period ending up to two full fiscal years after the Divestment, if Medtronic fully exercises its renewal options. These agreements may therefore limit our flexibility to operate the Juncos facility in the manner we believe is best for our business and/or increase our costs to operate the facility, and may also limit our ability divest ourselves of the facility if we have determined it is in the best interest of our business to do so, any of which could have a material adverse effect on our business, financial condition, results of operations, and cash flows.

Under the Transition Manufacturing and Supply Agreement, Medtronic will continue to provide us certain product development and manufacturing services for only a limited period of time after the Separation, and we will therefore need to put in place alternatives to maintain our ability to develop and produce certain of our products.

Medtronic currently provides us certain product development and manufacturing services with respect to components for next-generation CGMs in our development pipeline, as well as certain of our other products. Under the Transition Manufacturing and Supply Agreement, Medtronic will continue to provide us with these services for a term of two years after the Separation, which term may be renewed at Medtronic’s option for an additional term of one year, after which time we will need to have in place alternative third-party suppliers. We will need to make significant investments in connection with putting in place alternatives, including evaluating and validating new third-party suppliers, scaling operations for commercial production, and integrating componentry into our supply chains and production flows. If we are unable to effectively put alternative suppliers in place in a timely fashion, our ability to develop and produce our next-generation CGM products and certain other products may be negatively impacted, which could have a material adverse effect on our business, financial condition, results of operations, and cash flows.

Following the Separation and the Divestment, certain of our directors and executive officers may have actual or potential conflicts of interest because of their positions with or financial interests in Medtronic.

Certain of our expected executive officers and directors will continue to own equity interests in Medtronic following the Separation and the Divestment, whether because of their current or former positions with Medtronic or otherwise. In addition, certain of Medtronic’s current executive officers are expected to become our directors. These factors could create, or appear to create, potential conflicts of interest to the extent that we and Medtronic face decisions that could have different implications for the two companies. For example, potential conflicts of interest could arise in connection with the resolution of any dispute that may arise between us and Medtronic regarding the terms of the agreements governing the Separation and the relationship thereafter between the companies. In addition, given these relationships, PWD or other third parties may confuse our business with that of Medtronic, or there may

be a perceived link between our and Medtronic’s products, each of which could affect our business, competitive position, and market perception.

We expect that provisions relating to certain relationships and transactions in our amended and restated certificate of incorporation will address certain actual or potential conflicts of interest between us, on the one hand, and Medtronic and its directors, officers, or employees who are our directors, officers, or employees, on the other hand. By becoming our stockholder, you will be deemed to have notice of, and consented to, these provisions of our amended and restated certificate of incorporation. For example, we are expected to renounce any interest or expectancy of ours in any corporate opportunities that are presented to our directors, officers, or employees who are also directors, officers, or employees of Medtronic, and such director, officer, or employee will have no duty to communicate or present such corporate opportunity to us, in each case so long as such corporate opportunity was not expressly offered to such person solely in their capacity as our director or officer. Although these provisions are designed to resolve certain conflicts of interest between us and Medtronic fairly, we cannot assure you that any conflicts of interest will be so resolved. See “Description of Capital Stock—Conflicts of Interest; Corporate Opportunities.”

The divestment of Medtronic’s remaining equity interest in us may not occur.

Upon completion of this offering, Medtronic will continue to own 90.03% of the voting power of our shares of common stock eligible to vote in the election of our directors (or 88.70% if the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments). While Medtronic has informed us that, following the completion of this offering, it intends to effect the Divestment, Medtronic has no obligation to complete the Divestment. Whether Medtronic proceeds with the Divestment, in whole or in part, and the timing thereof, is in Medtronic’s sole discretion and may be subject to a number of conditions, including the receipt of any necessary regulatory or other approvals, the existence of satisfactory market conditions, the receipt of the Tax Opinions, and Medtronic having sufficient distributable reserves to effect the Divestment. Even if Medtronic elects to pursue the Divestment, Medtronic has the right to abandon or change the structure of the Divestment if Medtronic determines, in its sole discretion, that the Divestment is not in the best interests of Medtronic or its shareholders.

Furthermore, if the Divestment does not occur, and Medtronic does not otherwise dispose of its shares of our common stock, the risks relating to Medtronic’s control of us and the potential business conflicts of interest between us and Medtronic will continue to be relevant to our stockholders. See “—Risks Related to Our Relationship with Medtronic—Following the completion of this offering, Medtronic will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.”

If Medtronic completes the Divestment in a transaction that is intended to be generally tax-free for U.S. federal income tax purposes and there is later a determination that certain steps of the Separation or the Divestment are taxable because the facts, assumptions, representations, or undertakings underlying the Tax Opinions are incorrect or for any other reason, then Medtronic and its shareholders could incur significant U.S. federal, state, and foreign income tax liabilities and we could incur significant liabilities through our indemnification obligations under the Tax Matters Agreement.

If Medtronic completes the Divestment in a transaction that is intended to be tax-free for U.S. federal income tax purposes, Medtronic will have received the Tax Opinions from its U.S. tax advisors substantially to the effect that, among other things, the Divestment will qualify as a transaction that is generally tax-free for U.S. federal income tax purposes under Section 355 of the Code. Medtronic does not intend to obtain a private letter ruling from the U.S. Internal Revenue Service (the “IRS”) regarding the qualification of the Divestment (or other steps of the Separation) as transactions that are tax-free for U.S. federal income tax purposes. The consummation of the Divestment is conditioned on, among other things, the receipt of the Tax Opinions. The Tax Opinions will rely on certain facts, assumptions, representations, and undertakings from us and Medtronic regarding the past and future conduct of the companies’ respective businesses and other matters. If any of these facts, assumptions, representations, or undertakings are incorrect or not otherwise satisfied, Medtronic and its shareholders may not be able to rely on the Tax Opinions and could be subject to significant tax liabilities. The legal authorities on which the

Tax Opinions will be based are subject to change or differing interpretations at any time, possibly with retroactive effect. Opinions of counsel are not binding on the IRS or the courts, and notwithstanding the Tax Opinions, the IRS could determine on audit that certain steps of the Separation or the Divestment are taxable if it determines that any of these facts, assumptions, representations, or undertakings are not correct or have been violated or if it disagrees with the conclusions in the Tax Opinions, or for other reasons, including as a result of changes in law with retroactive effect or certain significant changes in our stock ownership or the stock ownership of Medtronic following the completion of the Divestment.

If certain steps of the Separation or the Divestment are determined to be taxable for U.S. federal income tax purposes, then Medtronic or its shareholders could incur significant U.S. federal income tax liabilities and we could also incur significant liabilities under the Tax Matters Agreement. Under the Tax Matters Agreement, we will generally be required to indemnify Medtronic against taxes incurred by Medtronic arising from any breach of representations made by us (including those provided in connection with the Tax Opinions) or from certain other acts or omissions, in each case that result in certain steps of the Separation or the Divestment failing to meet the requirements under Sections 355, 361, and 368(a)(1)(D) of the Code, and we will also be responsible for 50% of certain unanticipated tax liabilities related to the Separation or the Divestment, if such taxes materialize. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Tax Matters Agreement.”

Although, under the Tax Matters Agreement, Medtronic will generally be responsible for taxes due with respect to consolidated or joint tax returns for all periods prior to the completion of this offering for consolidated groups including Medtronic or its subsidiaries and us and our subsidiaries, we nevertheless will have joint and several liability with Medtronic for certain consolidated U.S. federal income taxes of such groups for taxable periods during which we or our affiliates were members of such groups.

Following the completion of this offering, we do not expect to be included in a U.S. federal consolidated group tax return with affiliates of Medtronic. Moreover, Medtronic will generally be responsible for all U.S. federal income taxes imposed on a Medtronic consolidated tax return group and state and foreign income, franchise, capital gain, withholding, and similar taxes imposed on a consolidated, combined, or unitary tax return group (or similar tax group under non-U.S. law) that includes Medtronic or one of its subsidiaries with respect to taxable periods (or portions thereof) that end on or prior to the date of the completion of this offering.

Nevertheless, because certain of our subsidiaries were members of a consolidated U.S. federal income tax group that includes certain subsidiaries of Medtronic, such subsidiaries have (and will continue to have following the offering and, if pursued, the Divestment) joint and several liability with such subsidiaries of Medtronic for the consolidated U.S. federal income taxes of such members of the Medtronic group relating to the taxable periods in which such subsidiaries were part of such group. Such liabilities include liabilities in respect of Medtronic’s litigation for fiscal years 2005 and 2006 that relate to the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico, one of Medtronic, Inc.’s key manufacturing sites, which could be material to us. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Tax Matters Agreement.”

We may be affected by significant restrictions, including on our ability to engage in certain corporate transactions, for a two-year period following the completion of the Divestment, if pursued, in order to avoid triggering significant tax-related liabilities.

To preserve the generally tax-free treatment of certain steps of the Separation and the Divestment for U.S. federal income tax purposes, we will be restricted under the Tax Matters Agreement from taking certain actions (including, among others, actions related to the sale and/or discontinuance of certain business activities and/or assets) that would prevent certain steps of the Separation and the Divestment from being tax-free for U.S. federal income tax purposes. Under the Tax Matters Agreement, for the two-year period following the completion of the Divestment, if pursued, we will be subject to specific restrictions on our ability to enter into acquisition, merger, liquidation, sale, and stock redemption transactions with respect to shares of our common stock. These restrictions may limit our ability to pursue certain strategic transactions or other transactions that we may believe to be in the best interests of our stockholders or that might increase the value of our business. These restrictions will not limit the

acquisition of other businesses by us for cash consideration. In addition, under the Tax Matters Agreement, we will generally be required to indemnify Medtronic against certain tax liabilities that may result from the acquisition of our stock or assets, even if we do not participate in or otherwise facilitate the acquisition. Furthermore, we will be subject to specific restrictions on discontinuing the active conduct of our trade or business, the issuance or sale of stock or other securities (including securities convertible into our stock but excluding certain compensatory arrangements), and sales of assets outside the ordinary course of business. These restrictions may reduce our strategic and operating flexibility. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Tax Matters Agreement.”

Our rebranding strategy in connection with the Separation will involve substantial costs and may not produce the intended benefits if it is not favorably received by PWD or third-party partners. In addition, our continued use of legacy Medtronic branding, including the “Medtronic” brand, could adversely affect our reputation.

In connection with the Separation, we have incurred, and will continue to incur, substantial costs to rebrand the Company as “MiniMed Group, Inc.” and change the branding for certain of our products around the world. Successful promotion of this rebranding will depend on the effectiveness of our marketing efforts and our ability to continue to provide reliable products to PWD during the course of our transition to becoming a standalone public company. We have invested, and will continue to invest, significant resources to promote our new branding, but we cannot predict with certainty how these marketing efforts will be received, and we cannot assure you that we will be able to achieve or maintain brand recognition or status under any new names and marks at a level that is comparable to the recognition and status we historically enjoyed as part of Medtronic. If our rebranding strategy does not produce the intended benefits, our ability to retain existing customers and third-party partners and continue to attract new customers and third-party partners could be impacted, which could adversely affect our business, results of operations, financial condition, or cash flows. See “—Business and Operational Risks—If we fail to expand and maintain an effective sales force, predict and adapt to changes in markets, or successfully develop and maintain our relationships with intermediaries, our business, prospects, and brand may be materially and adversely affected.”

In addition, our continued use of legacy Medtronic branding could adversely affect our reputation. In connection with the Separation, Medtronic will license certain trademarks related to the “Medtronic” brand to us. We expect to continue to use the “Medtronic” brand for an agreed upon period of time following the completion of this offering. The license permits us to make ongoing use of certain variations of the legacy Medtronic branding for such agreed upon period of time following the Separation, based on our use of the legacy Medtronic branding prior to the Separation. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Trademark Agreements.”

As a result of this continued use of the legacy Medtronic branding, there is a risk that conduct or events adversely affecting Medtronic’s reputation could also adversely affect our reputation or the reputation of our brands. Moreover, the licenses to the legacy Medtronic branding include quality control provisions obligating us and any sublicensees to remain in compliance with applicable law and quality standards. Failure by us or any sublicensees to comply with these obligations could potentially result in termination of the licenses, which could adversely affect our business, results of operations, financial condition, and cash flows.

The transfer of certain assets and liabilities from Medtronic to us contemplated by the Separation will not be complete prior to the completion of this offering.

We expect that the Separation will be substantially completed prior to the completion of this offering. However, the Separation Agreement will provide that, in order to ensure compliance with applicable law, to obtain necessary governmental approvals and other consents, and for other business reasons, we and Medtronic will defer until after the completion of this offering certain transfers of assets and assumptions of liabilities of businesses in certain jurisdictions. See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation—Separation Agreement—Deferred Markets.”

The net profits or losses from the operation of businesses that are not transferred prior to the completion of this offering will, to the extent reasonably practicable and permitted by applicable law, be provided to us. Nevertheless, these arrangements may introduce additional complexities to our business. We cannot assure you that any transfer

that is not completed prior to the completion of this offering will occur promptly following the completion of this offering, or at all, including if we are not able to obtain necessary governmental approvals or other consents, or if there are any unanticipated developments or changes, including changes in laws or regulations, or that Medtronic will operate such businesses as we would have. Further, effecting the transfers could require more resources than expected, including out-of-pocket costs and expenses and internal management and employee time and resources, which could adversely affect our business, results of operations, financial condition, and cash flows. In the event transfers are significantly delayed or do not occur, we may not realize all of the anticipated benefits of the Separation, which could adversely affect our business, results of operations, financial condition, and cash flows.

The transfer to us of certain contracts, permits, and other assets and rights may require the consents or approvals of, or provide other rights to, third parties and governmental authorities. If such consents or approvals are not obtained, we may not be entitled to the benefit of such contracts, permits, and other assets and rights, which could increase our expenses or otherwise harm our business and financial performance.

The Separation Agreement will provide that certain contracts, permits, and other assets and rights are to be transferred from Medtronic or its subsidiaries to us or our subsidiaries in connection with the Separation. The transfer of certain of these contracts, permits, and other assets and rights may require consents or approvals of third parties or governmental authorities or provide other rights to third parties. In addition, in some circumstances, we and Medtronic are joint beneficiaries of contracts, and we and Medtronic may need the consents of third parties in order to split or separate the existing contracts or the relevant portion of the existing contracts to us or Medtronic.

Some parties may use consent requirements or other rights to seek to terminate contracts or obtain more favorable contractual terms from us, which, for example, could take the form of adverse price changes, require us to expend additional resources in order to obtain the services or assets previously provided under the contract, or require us to seek arrangements with new third parties or obtain letters of credit or other forms of credit support. If we are unable to obtain required consents or approvals, we may be unable to obtain the benefits, permits, assets, and contractual commitments that are intended to be allocated to us as part of our separation from Medtronic, and we may be required to seek alternative arrangements to obtain services and assets which may be more costly or of lower quality. The termination or modification of these contracts or permits or the failure to timely complete the transfer or separation of these contracts or permits could negatively impact our business, financial condition, results of operations, and cash flows.

The assets that we acquire from Medtronic in the Separation may not be sufficient for us to operate as a standalone company, and we may experience difficulty in separating our assets from Medtronic.

Because we have not operated as a standalone company in the past, we may need to acquire assets in addition to those transferred by Medtronic to us in connection with the Separation. We may also face difficulty in separating our assets from Medtronic’s assets and integrating newly acquired assets into our business. The Separation is complex in nature and unanticipated developments or changes, including changes to applicable laws or regulations (or interpretations thereof), required consents or approvals, or other challenges in executing the Separation could delay or prevent the completion of certain aspects of the Separation, require more resources than expected (including out-of-pocket costs and expenses and internal management and employee time and resources), or cause the Separation to occur on terms or conditions that are different or less favorable to us than expected. Our business, results of operations, financial condition, and cash flows could be adversely affected if we have difficulty operating as a standalone company, fail to acquire assets that prove to be important to our operations, or incur unexpected costs in separating our assets from Medtronic’s assets or integrating newly acquired assets.

Risks Related to Our Relationship with Medtronic

Following the completion of this offering, Medtronic will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.

not be able to affect the outcome of any matter submitted to our stockholders for approval as long as Medtronic or its successor-in-interest beneficially owns a majority of the total voting power of our outstanding shares of common stock.

As long as Medtronic or its successor-in-interest beneficially owns a majority of the total voting power of our outstanding shares of common stock, it will generally be able to control, whether directly or indirectly through its ability to remove and elect directors, and subject to applicable law, all matters affecting us without the approval of other stockholders, including:

•determinations with respect to our business direction and policies, including the election and removal of directors and the appointment and removal of officers;

•determinations with respect to corporate transactions, such as mergers, business combinations, or dispositions of assets;

•our financing and dividend policies;

•our compensation and benefit programs and other human resources policy decisions;

•termination of, changes to, or determinations under our agreements with Medtronic relating to the Separation;

•determinations with respect to tax matters; and

•changes to any other agreements that may adversely affect us.

If Medtronic does not complete the Divestment or otherwise dispose of its remaining equity interest in our Company, or if Medtronic purchases shares of our common stock in the open market following the completion of this offering, it could remain our controlling stockholder for an extended period of time or indefinitely. Even if Medtronic were to beneficially own less than a majority of the total voting power of our outstanding shares of common stock, Medtronic may be able to influence the outcome of corporate actions requiring stockholder approval for as long as it owns a significant portion of our common stock.

Medtronic’s interests may not be the same as, or may conflict with, the interests of our other stockholders. Actions that Medtronic takes with respect to us, as a controlling or significant stockholder, may not be favorable to us or our other stockholders.

Following the completion of this offering, we will be a “controlled company” as defined under the corporate governance rules of Nasdaq and, as a result, will qualify for exemptions from certain corporate governance requirements of Nasdaq.

•the requirement that the Board be composed of a majority of independent directors;

•the requirement that the Nominating and Corporate Governance Committee be composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities or, if no such committee exists, that our director nominees be selected or recommended by independent directors constituting a majority of the Board’s independent directors in a vote in which only independent directors participate;

•the requirement that the Compensation and Talent Committee be composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities; and

•the requirement for an annual performance evaluation of the Nominating and Corporate Governance Committee and the Compensation and Talent Committee.

We intend to avail ourselves of the “controlled company” exemption under the corporate governance rules of Nasdaq. Accordingly, we will not be required to have a majority of “independent directors” on the Board as defined under the rules of Nasdaq. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.

If Medtronic sells a sufficiently large equity interest in us to a third party in a private transaction, such transaction could result in a change of control of us, and you may not realize any change-of-control premium on your shares of our common stock.

Upon completion of this offering, Medtronic will continue to own 90.03% of the total voting power of our outstanding shares of common stock (or 88.70% if the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments). Medtronic will have the ability, should it choose to do so, to sell some or all of its shares of our common stock in a privately negotiated transaction, which, if sufficient in size, could result in a change of control of us.

The ability of Medtronic to privately sell its shares of our common stock, with no requirement for a concurrent offer to be made to acquire all of the shares of our common stock that will be publicly traded following the completion of this offering, could prevent you from realizing any change-of-control premium on your shares of our common stock that may otherwise accrue to Medtronic on its private sale of shares of our common stock. In the event of a change-of-control, our future indebtedness may be subject to acceleration, and our other commercial agreements and relationships, including any remaining agreements with Medtronic, could be impacted. The occurrence of any of these events could have a material adverse affect on our business, results of operations, financial condition, and cash flows.

Risks Related to This Offering and Ownership of Our Common Stock

We cannot be certain that an active trading market for our common stock will develop or be sustained following the completion of this offering.

Prior to the completion of this offering, there has been no public market for our common stock. We cannot assure you that an active trading market for shares of our common stock will develop or be sustained following the completion of this offering. If an active trading market does not develop, you may have difficulty selling your shares of our common stock at an attractive price or at all. An inactive trading market could also impair our ability to raise capital by selling shares of our common stock, our ability to attract and motivate our employees through equity incentive awards, and our ability to acquire businesses, brands, assets, or technologies by using shares of our common stock as consideration. Furthermore, the liquidity of the market for shares of our common stock may be constrained for as long as Medtronic continues to own a significant portion of our common stock.

The stock price of our common stock may fluctuate significantly.

We cannot predict the prices at which shares of our common stock may trade after the completion of this offering. The price for shares of our common stock in this offering was determined by negotiations among us, Medtronic, and representatives of the underwriters, and it may not be indicative of prices that will prevail in the open market following the completion of this offering. Consequently, you may not be able to sell your shares of our common stock at or above the initial public offering price at the time that you would like to sell.

The market price of shares of our common stock may be highly volatile and fluctuate significantly due to a number of factors, some of which may be beyond our control, including:

•our quarterly or annual earnings or those of our competitors;

•variations in our quarterly dividends, if any, to stockholders;

•actual or anticipated fluctuations in our operating results or those of our competitors;

•publication of research reports about us, our competitors, or our industry, changes in, or failure to meet, estimates made by securities analysts or ratings agencies of our financial and operating performance, or lack of research reports by industry analysts or ceasing of analyst coverage;

•additions or departures of key management personnel;

•strategic actions or announcements by us or our competitors;

•adverse market reaction to any indebtedness we may incur or securities we may issue in the future;

•changes in accounting standards, policies, guidelines, interpretations, or principles;

•changes to the regulatory and legal environment in which we operate;

•litigation or governmental investigations initiated against us;

•reputational issues, including reputational issues involving our competitors and their products, Medtronic, and our third-party partners;

•actions by institutional stockholders;

•any ineffectiveness of our internal controls;

•whether, when, and in what manner Medtronic completes the Divestment, and other announcements made or actions taken by Medtronic, whether in respect of the Divestment or otherwise;

•overall market fluctuations and domestic and worldwide economic and political conditions; and

•other factors described in this “Risk Factors” section and elsewhere in this prospectus.

Stock markets in general have experienced volatility that has often been unrelated to the operating performance of a particular company. These broad market fluctuations may adversely affect the trading price of our common stock. If any of the forgoing events occur, it could cause our stock price to fall and may expose us to lawsuits, including securities class action litigation, that, even if unsuccessful, could result in substantial costs and divert our management’s attention and resources. You should consider an investment in shares of our common stock to be risky, and you should invest in shares of our common stock only if you can withstand a significant loss and wide fluctuations in the market value of your investment.

The Divestment, if pursued, or future sales by Medtronic or other holders of shares of our common stock, or the perception that the Divestment or such sales may occur, including following the expiration of the lock-up period, could cause the price of our common stock to decline.

Upon completion of this offering, Medtronic will continue to own 90.03% of our outstanding shares of common stock (or 88.70% if the underwriters exercise in full their option to purchase additional shares of our common stock from us). These shares will be “restricted securities” as that term is defined in Rule 144 (“Rule 144”) under the Securities Act of 1933, as amended (the “Securities Act”). Subject to contractual restrictions, including the lock-up agreements described in the paragraph below, Medtronic will be entitled to sell these shares in the public market only if the sale of such shares is registered with the SEC or if the sale of such shares qualifies for an exemption from registration under Rule 144 or any other applicable exemption under the Securities Act. We are unable to predict with certainty whether or when Medtronic will complete the Divestment or otherwise sell a substantial number of shares of our common stock. The distribution or sale by Medtronic of a substantial number of shares of our common stock following the completion of this offering, or a perception that such a distribution or sale could occur, could significantly reduce the prevailing market price of shares of our common stock. Upon completion of this offering, except as otherwise described in this prospectus, all of the shares of our common stock to be sold in this offering will be freely tradable without restriction or further registration under the Securities Act, assuming they are not held by our affiliates.

In connection with this offering, we, our executive officers, our directors, and Medtronic have agreed with the underwriters that, except with the prior written consent of Goldman Sachs & Co. LLC and BofA Securities, Inc., we and they will not, subject to certain exceptions, during the period beginning on the date of this prospectus and continuing through the date that is 180 days after the date of this prospectus, offer, sell, contract to sell, pledge, or otherwise dispose of or hedge, directly or indirectly, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, and may, in their sole discretion and at any time without notice, release all or any portion of the shares of our common stock subject to lock-up agreements. When the lock-up period expires, we and our stockholders subject to lock-up agreements will be able to sell shares of our common stock in the public market. Sales of a substantial number of shares of our common stock upon expiration of the lock-up agreements, the perception that these sales may occur, or early release of these lock-up agreements could cause the market price of shares of our common stock to decline or make it more difficult for you to sell your shares of our common stock at a time and price that you deem appropriate.

If we are unable to implement and maintain effective internal control over financial reporting in the future, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares of our common stock could be adversely affected.

As a standalone public company, we will be required to maintain internal control over financial reporting and to report any material weaknesses in our internal control. In addition, beginning with our second annual report on Form 10-K, we expect that we will be required to furnish a report by our management on the effectiveness of our internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act. Our independent registered public accounting firm will also be required to express an opinion as to the effectiveness of our internal control over financial reporting beginning with our second annual report on Form 10-K. At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed, or operating.

The process of designing, implementing, and testing the internal control over financial reporting required to comply with this obligation is complex, time-consuming, and costly. If we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner or to assert that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, investors could lose confidence in the accuracy and completeness of our financial reports and the market price of shares of our common stock could be adversely affected. We could also become subject to investigations by the SEC, Nasdaq, or other regulatory authorities, which could require additional financial and management resources.

The obligations associated with being a standalone public company will require significant resources and management attention.

Following the effectiveness of the registration statement of which this prospectus forms a part, we will be directly subject to reporting and other obligations under the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act, and the rules and regulations of the SEC and Nasdaq. As a standalone public company, we will be required to:

•prepare and distribute periodic reports, proxy statements, and other stockholder communications in compliance with the federal securities laws and rules;

•have our own board of directors and committees thereof, which comply with federal securities laws and rules and applicable stock exchange requirements;

•maintain an internal audit function;

•institute our own financial reporting and disclosure compliance functions;

•establish an investor relations function; and

•establish internal policies, including those relating to trading in our securities and disclosure controls and procedures.

These reporting and other obligations will place significant demands on our management, diverting their time and attention from sales-generating activities to compliance activities, and require increased administrative and operational costs and expenses that we did not incur prior to the Separation, which could adversely affect our business, results of operations, financial condition, and cash flows.

You will experience immediate and substantial dilution following the completion of this offering, and your percentage ownership in us may be further diluted in the future.

The initial public offering price per share of our common stock will be substantially higher than our pro forma net tangible book value per share of our common stock upon completion of this offering. As a result, you will pay a price per share of our common stock that substantially exceeds the per share book value of our tangible assets after subtracting our liabilities. Assuming an initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, you will incur immediate and substantial dilution in pro forma net tangible book value in an amount of $21.62 per share of our common stock.

In the future, your percentage ownership in us may be further diluted if we issue additional shares of our common stock or convertible debt securities in connection with acquisitions, capital market transactions, or other corporate purposes, including equity awards that we may grant to our directors, officers, and employees. In connection with this offering, we intend to file a registration statement on Form S-8 to register the shares of our common stock that we expect to reserve for issuance under our proposed equity incentive plan and employee stock purchase plan. It is anticipated that the Compensation and Talent Committee will grant additional equity awards to our employees and directors following the completion of this offering, from time to time, under our proposed equity incentive plan and employee stock purchase plan. We cannot predict with certainty the size of future issuances of shares of our common stock or the effect, if any, that future issuances and sales of shares of our common stock will have on the market price of shares of our common stock. Any such issuance could result in substantial dilution to our existing stockholders.

In addition, following the completion of this offering, our employees will have rights to receive shares of our common stock as a result of the conversion of their Medtronic equity awards for our equity awards. The conversion of these Medtronic awards into our awards is described in further detail in the section of this prospectus entitled “Certain Relationships and Related Person Transactions—Employee Matters Agreement—Equity Incentive Compensation.” As of the date of this prospectus, the exact number of shares of our common stock that will be subject to the converted equity awards is not determinable, and, therefore, it is not possible to determine the extent to which your percentage ownership in us could be diluted as a result of the conversion.

The Board will be authorized, without further vote or action by our stockholders, to provide for the issuance from time to time of shares of our preferred stock in series and, as to each series, to fix: the designation; the dividend rate and the preferences, if any, which dividends on that series will have compared to any other class or series of our capital stock; the voting rights, if any; the liquidation preferences, if any; the conversion privileges, if any; and the redemption price or prices and the other terms of redemption, if any, applicable to that series. The terms of one or more series of preferred stock could dilute the voting power or reduce the value of our common stock. For example, we could grant the holders of our preferred stock rights to elect directors in all events or on the occurrence of specified events or the right to veto specified transactions. In addition, the repurchase or redemption rights or liquidation preferences that we could assign to holders of our preferred stock could affect the residual value of our common stock. See “Description of Capital Stock—Preferred Stock.”

Following the completion of this offering, we expect to have debt obligations that could adversely affect our business, results of operations, or financial condition.

In connection with the Separation, we have entered into the Revolving Credit Facility (as defined in the section of this prospectus entitled “Description of Certain Indebtedness”). In addition, we may incur additional indebtedness in the future. This indebtedness could have important, adverse consequences to us and our investors, including:

•requiring a substantial portion of our cash flow from operations to make interest payments;

•making it more difficult to satisfy other obligations;

•increasing the risk of a future credit ratings downgrade of our debt, which could increase future debt costs and limit the future availability of debt financing;

•increasing our vulnerability to general adverse economic and industry conditions;

•reducing the cash flow available to fund capital expenditures and other corporate purposes and to grow our business;

•limiting our ability to pay dividends;

•limiting our flexibility in planning for, or reacting to, changes in our business and industry; and

•limiting our ability to borrow additional funds as needed or take advantage of business opportunities as they arise, pay cash dividends, or repurchase shares of our common stock.

The risks described above will increase with the amount of indebtedness we incur in the future. Furthermore, to the extent our indebtedness bears interest at variable rates, our ability to borrow additional funds may be reduced and the risks described above would intensify if these rates were to increase significantly, whether because of an increase in market interest rates or a decrease in our creditworthiness. In addition, our actual cash requirements in the future may be greater than expected. Our cash flow from operations may not be sufficient to service our outstanding debt or to repay the outstanding debt as it becomes due, and we may not be able to borrow money, sell assets, or otherwise raise funds on acceptable terms, or at all, to service or refinance our debt.

Furthermore, the restrictive covenants under the Revolving Credit Facility may limit our operating flexibility by limiting our ability to, among other things, take advantage of financing, merger and acquisition, or other opportunities, in particular if we cannot meet certain pro forma leverage ratio incurrence tests. In addition, we are required to comply with certain financial maintenance covenants under the Revolving Credit Facility. Our ability to comply with such covenants may be affected by events beyond our control, including prevailing economic, financial, and industry conditions.

We are a holding company and our only material assets are our equity interests in our subsidiaries. As a consequence, we depend on the ability of our subsidiaries to pay dividends and make other payments and distributions to us in order to meet our obligations.

We are a holding company with limited direct business operations, including conducting certain operational activities in anticipation of the planned separation of the Diabetes Operating Unit from Medtronic. Our subsidiaries own substantially all of our assets and conduct substantially all of our operations. Dividends from our subsidiaries and permitted payments to us under arrangements with our subsidiaries are our principal sources of cash to meet our obligations. These obligations include operating expenses and interest and principal on current and any future borrowings. Our subsidiaries, including certain subsidiaries organized outside the United States, may not be able to, or may not be permitted to, pay dividends or make distributions to enable us to meet our obligations. Each subsidiary is a distinct legal entity and, under certain circumstances, legal, tax, and contractual restrictions may limit our ability to obtain cash from our subsidiaries. If the cash we receive from our subsidiaries pursuant to dividends and other arrangements is insufficient to fund any of our obligations, or if a subsidiary is unable to pay future dividends or distributions to us to meet our obligations, we may be required to raise cash through, among other things, the incurrence of debt (including convertible or exchangeable debt), the sale of assets, or the issuance of

equity. Our liquidity and capital position are highly dependent on the performance of our subsidiaries and their ability to pay future dividends and distributions to us as anticipated. The evaluation of future dividend sources and our overall liquidity plans are subject to a variety of factors, including current and future market conditions, which are subject to change. Our inability to generate sufficient cash flows to satisfy our debt obligations, or to refinance our indebtedness on commercially reasonable terms or at all, could adversely affect our business, results of operations, financial condition, and cash flows and our ability to satisfy our obligations under our indebtedness or pay dividends on our common stock.

We do not expect to pay dividends on our common stock for the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could be adversely affected, resulting in a decrease in the market price of shares of our common stock.

The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported in our combined financial statements. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, net sales, and expenses that are not readily apparent from other sources. If our assumptions change or if actual circumstances differ from our assumptions, our results of operations could be adversely affected and could fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of shares of our common stock.

Certain provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, and of Delaware law, may prevent or delay an acquisition of us, which could decrease the trading price of our common stock.

Our amended and restated certificate of incorporation and our amended and restated bylaws will contain provisions that are intended to deter coercive takeover practices and inadequate takeover bids and to encourage prospective acquirers to negotiate with the Board rather than to attempt an unsolicited takeover not approved by the Board. These provisions will include (1) the division of the Board into three classes of directors, with each class serving a staggered three-year term; (2) the ability of our directors, and not holders of shares of our common stock, to fill vacancies on the Board (including those resulting from an enlargement of the Board); (3) the inability of holders of shares of our common stock to call a special meeting; (4) after Medtronic first ceases to beneficially own a majority of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors, the inability of holders of shares of our common stock to act by written consent; (5) procedures regarding how stockholders may present proposals or nominate directors for election at stockholder meetings; (6) authority of the Board to issue preferred stock without stockholder vote or action; and (7) from and after the first time that Medtronic no longer beneficially owns a majority of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors, removal of directors only for cause and only by the affirmative vote of at least two-thirds of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors.

In addition, after Medtronic ceases to “own” at least 15% of the voting power of our outstanding shares of “voting stock” (each as defined in Section 203 of the Delaware General Corporation Law (the “DGCL”)), Section

203 of the DGCL could also delay or prevent a change of control that you may favor. Section 203 of the DGCL generally prohibits a corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years following the time that such stockholder became an interested stockholder, subject to certain exceptions. See “Description of Capital Stock—Anti-Takeover Effects of Various Provisions of Delaware Law, Our Amended and Restated Certificate of Incorporation, and Our Amended and Restated Bylaws—Delaware Anti-Takeover Statute.”

Additionally, so long as Medtronic beneficially owns a majority of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors, and therefore has the ability to direct the election of all the members of the Board, directors designated by Medtronic to serve on the Board may have the ability to authorize a party, including a potential transferee of Medtronic’s shares of our common stock, to become an interested stockholder such that the restrictions of Section 203 of the DGCL would not apply to such party.

We believe these provisions will protect our stockholders from coercive or otherwise unfair takeover tactics by requiring potential acquirers to negotiate with the Board and by providing the Board with more time to assess any acquisition proposal. These provisions are not intended to make us immune from takeovers. However, these provisions will apply even if the offer may be considered beneficial by some of our stockholders and could delay or prevent an acquisition that the Board determines is not in the best interests of us and our stockholders. These provisions may also prevent or discourage attempts to remove and replace incumbent directors.

Our classified board of directors and other features of our amended and restated certificate of incorporation will make it more difficult for our stockholders to remove directors and may prevent our stockholders from effecting a change in the control of our Board.

The classified board provision that will be included in our amended and restated certificate of incorporation could have the effect of making the replacement of incumbent directors more time-consuming and difficult. In addition, from and after the first time that Medtronic no longer beneficially owns a majority of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors, directors may be removed only for cause and only by the affirmative vote of at least two-thirds of the voting power of our outstanding shares of capital stock entitled to vote generally in the election of directors. The “for cause” standard, the supermajority removal requirement, and the classified board provision will make it more difficult for our stockholders to remove directors and will increase the likelihood that incumbent directors will retain their positions. These features of our amended and restated certificate of incorporation may delay, defer, or prevent a transaction or a change in control of us or a transaction that otherwise might be in the best interest of our stockholders.

Our amended and restated certificate of incorporation will provide that certain courts within the State of Delaware or the federal district courts of the United States will be the sole and exclusive forum for the resolution of certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against us or our directors, officers, employees, or stockholders.

Our amended and restated certificate of incorporation will provide, in all cases to the fullest extent permitted by law, that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery located within the State of Delaware will be the sole and exclusive forum for (1) any derivative action or proceeding brought on our behalf; (2) any action asserting a claim that is based upon a violation of a duty owed by any of our current or former directors, officers, employees, or stockholders to us or our stockholders; (3) any action asserting a claim arising pursuant to our amended and restated certificate of incorporation or our amended and restated bylaws; (4) any action asserting a claim arising pursuant to any provision of the DGCL or as to which the DGCL confers jurisdiction on the Court of Chancery located within the State of Delaware; and (5) any action asserting a claim governed by the internal affairs doctrine. However, if the Court of Chancery located within the State of Delaware does not have jurisdiction over any such action, the action may be brought instead in the United States District Court for the District of Delaware.

Our amended and restated certificate of incorporation will provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States will be the sole and exclusive forum for the resolution of any action asserting a claim arising under the Securities Act.

These exclusive forum provisions may impose additional costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware, or limit a stockholder’s ability to bring a claim in a judicial forum that such stockholder finds favorable for disputes with us or our directors, officers, employees, or stockholders, which in each case may discourage such lawsuits with respect to such claims. It is possible that a court could find these exclusive forum provisions inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, and we may incur additional costs associated with resolving such matters in other jurisdictions, which could divert our management’s attention and otherwise adversely affect our business, results of operations, financial condition, and cash flows.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements, which do not relate strictly to historical or current facts and which reflect management’s assumptions, views, plans, objectives, and projections about the future. All statements other than statements of historical fact contained in this prospectus, including statements regarding our future results of operations and financial position, business strategy and plans, objectives of management for future operations and current expectations, or forecasts of future results, are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Our forward-looking statements may include statements related to our growth and growth strategies, developments in the markets for our products, therapies, and services, financial results, product development launches and effectiveness, research and development strategy, regulatory approvals, competitive strengths, the potential or anticipated direct or indirect impact of public health crises, severe weather events or climate change, and geopolitical conflicts on our business, results of operations, and financial condition, restructuring and cost-saving initiatives, intellectual property rights, litigation and tax matters, governmental proceedings and investigations, mergers and acquisitions, divestitures, market acceptance of our products, therapies and services, accounting estimates, financing activities, ongoing contractual obligations, working capital adequacy, value of our investments, our effective tax rate, our expected returns to stockholders, and sales efforts. In some cases, such statements may be identified by the use of terminology such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “will,” and similar words or expressions. Forward-looking statements in this prospectus include, but are not limited to, statements regarding: our ability to drive long-term stockholder value; development and future launches of products and continued or future acceptance of products, therapies, and services in our segments; expected timing for completion of research studies relating to our products; integration of new technologies, including AI and data analytics, into our products, therapies, and services; market positioning and performance of our products, including stabilization of certain product markets; divestitures and the potential benefits thereof; the costs and benefits of integrating previous acquisitions; anticipated timing for U.S. FDA and non-U.S. regulatory approval or clearance of new products; increased presence in new markets, including markets outside the United States; changes in the market and our market share; our ability to meet growing demand for our existing products; acquisitions and investment initiatives, including the timing of regulatory approvals as well as integration of acquired companies into our operations; the resolution of tax matters; our approach towards cost containment; our expectations regarding healthcare costs, including potential changes to reimbursement policies and pricing pressures; our expectations regarding changes to patient standards of care; our ability to identify and maintain successful business partnerships; the elimination of certain positions or costs related to restructuring initiatives; outcomes in our litigation matters and governmental proceedings and investigations; general economic conditions; the adequacy of available working capital and our working capital needs; our payment of dividends and redemption of shares; the continued strength of our balance sheet and liquidity; our accounts receivable exposure; our human capital management with respect to our global workforce; the management of EHS and sustainability matters; and the potential impact of our compliance with governmental laws and regulations and accounting guidance.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, results of operations, financial condition, and cash flows. These forward-looking statements speak only as of the date of this prospectus and are subject to a number of risks, uncertainties, and assumptions described in the “Risk Factors” section and elsewhere in this prospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. One must carefully consider forward-looking statements and understand that such forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and involve a variety of risks and uncertainties, known and unknown, including, among others, those discussed in the sections entitled “Business—Government Regulation and Product Approval Process” and “Risk Factors” in this prospectus, as well as those related to:

•competition in the diabetes market;

•technological developments and breakthroughs related to diabetes;

•pricing pressure for our products;

•potential challenges or delays in the development or manufacturing of new products;

•potential reduction or interruption in our supply, including partial or complete loss of one or more of our sole suppliers;

•market acceptance of our products;

•our research and development efforts;

•our marketing efforts and sales force;

•our relationships with HCPs and intermediaries;

•development arrangements, investments, licensing arrangements, joint ventures, strategic alliances, and partnerships with third parties;

•forecasting market demand;

•clinical and pre-clinical trials and market studies;

•clinical data and interim, preliminary, or “top-line” data from clinical trials;

•coverage and reimbursement for our products;

•failure to complete or achieve the intended benefits of acquisitions or divestitures;

•government regulations and adverse regulatory action;

•litigation results;

•quality problems;

•protection of our patent and other proprietary rights;

•healthcare policy changes;

•our information technology infrastructure and cybersecurity and privacy incidents;

•privacy laws and regulations;

•anti-corruption laws;

•climate change and legal, regulatory, and market measures related to climate change;

•EHS laws, regulations, and liabilities;

•sustainability practices and initiatives;

•tax laws and tax liabilities;

•our ability to achieve the expected benefits of and successfully execute the Separation, the Divestment, and related transactions;

•our status as a controlled company, and the possibility that Medtronic’s interests or those of certain of our executive officers and directors may conflict with our interests and the interests of our other stockholders;

•restrictions on our business, potential tax and indemnification liabilities, and substantial charges in connection with the Separation, the Divestment, and related transactions; and

•failure of our rebranding efforts in connection with the Separation to achieve market acceptance.

You should also carefully read the risk factors described in the section of this prospectus entitled “Risk Factors” for a description of the material risks that could, among other things, cause our actual results to differ materially from those expressed or implied in our forward-looking statements. You should understand that it is not possible to predict or identify all such factors and you should not consider the risks described above to be a complete statement of all potential risks and uncertainties. We do not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments, except as required by law.

USE OF PROCEEDS

We estimate that the net proceeds to us from this offering will be approximately $712,320,000 based on an assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

As part of the Separation, we intend to (i) retain an amount of the net proceeds from this offering such that we will have approximately $350 million of cash on hand, which we will use for general corporate purposes, (ii) use the excess of the net proceeds from this offering over such retained amount to repay (or cause one or more of our subsidiaries to repay) intercompany debt owed to Medtronic under a note, and (iii) to the extent the net proceeds from this offering exceed the retained amount and the principal amount of such note, pay additional consideration to an affiliate of Medtronic for certain assets transferred to us in the Separation.

Assuming no exercise of the underwriters’ option to purchase additional shares of our common stock from us to cover over-allotments, each $1.00 increase (decrease) in the assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately $27 million, assuming the number of shares of our common stock offered in this offering by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, an increase (decrease) of 1,000,000 shares in the number of shares of our common stock sold in this offering by us would increase (decrease) the net proceeds to us from this offering by approximately $25 million, assuming the initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual initial public offering price and other terms of this offering determined at the time of the pricing of this offering.

DIVIDEND POLICY

We do not expect to pay dividends on our common stock for the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future, if any, will be used for the operation and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of the Board and will depend upon many factors, including our financial condition, earnings, capital requirements, debt service obligations, restrictive covenants in the agreements governing our indebtedness, general economic business conditions, industry practice, legal requirements, and other factors that the Board may deem relevant. See “Risk Factors—Risks Related to This Offering and Ownership of Our Common Stock—We do not expect to pay dividends on our common stock for the foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the market price of our common stock.” and “Risk Factors—Risks Related to This Offering and Ownership of Our Common Stock—We are a holding company and our only material assets are our equity interests in our subsidiaries. As a consequence, we depend on the ability of our subsidiaries to pay dividends and make other payments and distributions to us in order to meet our obligations.”

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of October 24, 2025:

•on an actual basis as derived from our historical audited combined financial statements included elsewhere in this prospectus; and

•on an unaudited pro forma basis to give effect to (1) the Separation and related transactions as described in the section of this prospectus entitled “The Separation and Divestment Transactions—The Separation,” (2) the execution of a senior secured Revolving Credit Facility (as defined in the section of this prospectus entitled “Description of Certain Indebtedness”) with aggregate commitments of $500 million, and (3) the sale by us of 28,000,000 shares of our common stock in this offering based on an assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The cash and cash equivalents and capitalization information in the following table may not necessarily reflect what our cash and cash equivalents and capitalization would have been had we been operating as a standalone company as of October 24, 2025. In addition, the cash and cash equivalents and capitalization information in the following table may not necessarily reflect what our cash and cash equivalents and capitalization may be in the future.

The pro forma information set forth in the table below is illustrative only and will adjust based on the actual initial public offering price and other terms of this offering determined at the time of the pricing of this offering. The following table should be read in conjunction with the sections of this prospectus entitled “Summary Historical and Unaudited Pro Forma Combined Financial Data,” “Use of Proceeds,” “Unaudited Pro Forma Condensed Combined Financial Statements,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as our historical audited combined financial statements included elsewhere in this prospectus.


	As of October 24, 2025
(Dollars in Millions)	Actual		Pro Forma (1)
Cash and cash equivalents	$	8	$	350
Debt:
Total debt (2)	$	—	$	—
Stockholders’ Equity:
Common stock – par value $0.01 per share (1,000,000,000 authorized shares; 280,813,348 issued shares, pro forma)	$	—	$	3
Net investment from Parent	3,551		—
Additional paid-in capital	—		3,738
Accumulated other comprehensive income	8		8
Accumulated deficit	—		(5)
Total equity	3,560		3,745
Total capitalization	$	3,560	$	3,745

__________________

(1)Assuming no exercise of the underwriters’ option to purchase additional shares of our common stock from us to cover over-allotments, each $1.00 increase (decrease) in the assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately $27 million, assuming the number of shares of our common stock offered in this offering by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, an increase (decrease) of 1,000,000 shares in the number of shares of our common stock sold in this offering by us would increase (decrease) the net proceeds to us from this offering by approximately $25 million, assuming the initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

(2)In connection with the offering and the Separation, the Company has entered into a Revolving Credit Facility with a five-year term and aggregate commitments up to $500 million. The Revolving Credit Facility is expected to remain undrawn as of the date of the Separation.

DILUTION

Our historical net tangible book value as of October 24, 2025 was approximately $1,185 million. We do not present historical net tangible book value per share because it is not meaningful.

If you invest in shares of our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma net tangible book value per share of our common stock after giving effect to the Separation and this offering. Pro forma net tangible book value per share of our common stock represents:

•pro forma total assets less goodwill and other intangible assets after giving effect to the Separation;

•reduced by our pro forma total liabilities; and

•divided by the number of shares of our common stock outstanding after giving effect to the Separation.

As of October 24, 2025, after giving effect to the Separation, our pro forma net tangible book value was approximately $1,028 million, or $4.07 per share of our common stock based on 252,813,348 shares of our common stock outstanding immediately prior to the completion of this offering. After giving effect to this offering, our pro forma net tangible book value was approximately $1,370 million, or $4.88 per share of our common stock based on 280,813,348 shares of our common outstanding upon completion of this offering. This represents an immediate dilution of $21.62 per share of our common stock to new investors purchasing shares of our common stock in this offering. The following table illustrates this dilution per share of our common stock, assuming an initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us:


Assumed initial public offering price per share of our common stock			$26.50
Pro forma net tangible book value per share of our common stock after giving effect to the Separation			$4.07
Increase in pro forma net tangible book value per share of our common stock attributable to new investors purchasing shares of our common stock in this offering			$0.81
Pro forma net tangible book value per share of our common stock after giving effect to the Separation and this offering			$4.88
Dilution in pro forma net tangible book value per share of our common stock to new investors purchasing shares of our common stock in this offering			$21.62

Each $1.00 increase (decrease) in the assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, would not impact the pro forma net tangible book value or the pro forma net tangible book value per share of our common stock, but it would increase (decrease) dilution in pro forma net tangible book value per share of our common stock to new investors purchasing shares of our common stock in this offering by $1.00. The information discussed above is illustrative only and will adjust based on the actual initial public offering price and other terms of this offering determined at the time of the pricing of this offering.

If the underwriters exercise in full their option to purchase additional shares of our common stock from us to cover over-allotments, the pro forma net tangible book value per share of our common stock would be $4.81, and the dilution in pro forma net tangible book value per share of our common stock to new investors purchasing shares of our common stock in this offering would be $21.69.

The following table summarizes, on a pro forma as-adjusted basis as of October 24, 2025, after giving effect to this offering, the difference between our existing stockholder and new investors purchasing shares of our common stock in this offering with respect to the number of shares of our common stock purchased, the total consideration paid for these shares or to be paid for these shares, and the average price per share of our common stock paid by our existing stockholder or to be paid by new investors purchasing shares of our common stock in this offering, at the assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the

estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us:


	Shares Purchased			Total Consideration			Average Price Per Share
	Number	Percent		Dollars (in Millions)	Percent
Existing stockholder(1)	252,813,348	90.0%		$3,745	83.5%		$14.81
New investors	28,000,000	10.0%		$742	16.5%		$26.50
Total	280,813,348	100.0	%	$4,487	100.0	%	$15.98

__________________

(1)Total consideration represents the pro forma book value of the net assets being transferred to us by Medtronic in connection with the Separation.

Each $1.00 increase (decrease) in the assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, would increase (decrease) the total consideration paid by new investors purchasing shares of our common stock in this offering by approximately $28 million, or the percent of total consideration paid by new investors purchasing shares of our common stock in this offering by approximately 0.5%, assuming the number of shares of our common stock offered in this offering as set forth on the cover page of this prospectus remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. An increase (decrease) of 1,000,000 shares in the number of shares of our common stock sold in this offering would increase (decrease) the total consideration paid by new investors purchasing shares of our common stock in this offering by approximately $27 million, or the percent of total consideration paid by new investors purchasing shares of our common stock in this offering by approximately 0.5%, assuming the initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. The information discussed above is illustrative only and will adjust based on the actual initial public offering price and other terms of this offering determined at the time of the pricing of this offering.

The above discussion and tables are based on an assumed number of shares of our common stock outstanding upon completion of this offering. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities could result in further dilution to our stockholders.

THE SEPARATION AND DIVESTMENT TRANSACTIONS

The Separation

On May 21, 2025, Medtronic, our parent company, announced its intention to separate its Diabetes Operating Unit. In connection with the Separation and prior to the completion of this offering, KHC2, which is currently an indirect wholly-owned subsidiary of Medtronic, will enter into the Separation Agreement and various other agreements with Medtronic, which, together with the Separation Agreement, provide for certain transactions to effect the transfer of the assets and liabilities of the Diabetes Operating Unit to KHC2 and will result in the separation of the diabetes business from Medtronic. Prior to the completion of this offering, KHC2 will merge with and into MiniMed Group, Inc., with MiniMed Group, Inc. surviving the Merger and continuing as the counterparty to the agreements with Medtronic described below. In addition, these agreements will collectively govern various interim and ongoing relationships between us and Medtronic following the completion of this offering. We refer to these transactions collectively as the “Separation.”

We expect the following to occur in connection with the Separation:

•Separation Agreement – We and Medtronic will enter into the Separation Agreement, which will set forth our agreements with Medtronic regarding the principal actions to be taken in connection with the Separation and govern, among other matters, (1) the allocation of assets and liabilities to us and Medtronic (including our indemnification obligations, for potentially uncapped amounts, for certain liabilities relating to our business activities, whether incurred prior to or following the completion of this offering) and (2) certain matters with respect to this offering and the Divestment.

◦Transfer of Assets and Liabilities – Pursuant to the Separation Agreement, Medtronic will transfer the assets and liabilities comprising the Diabetes Operating Unit to us. Such transfer will occur pursuant to an internal reorganization that may take the form of asset transfers, demergers, share transfers, distributions, contributions, and similar transactions, and will involve the formation of new subsidiaries in numerous jurisdictions around the world to own and operate our business in such jurisdictions. In exchange for the transfer of assets by Medtronic to us, we will, as consideration, assume the liabilities associated with the Diabetes Operating Unit, issue to Medtronic shares of our common stock, and upon the completion of this offering, cause certain of our subsidiaries to make cash payments to Medtronic (or its designated affiliate) and to repay certain intercompany indebtedness.

•Registration Rights Agreement – We and Medtronic will enter into a registration rights agreement, pursuant to which we will grant Medtronic certain registration rights with respect to the shares of our common stock owned by Medtronic following the completion of this offering.

See “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation” for a more detailed discussion of the agreements described above. These agreements will collectively govern various interim and ongoing relationships between us and Medtronic following the completion of this offering. All of the agreements relating to the Separation will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of our separation from Medtronic. The terms of these agreements, including the costs of any services provided, may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See “Risk Factors—Risks Related to the Separation and the Divestment—The terms we will receive in our transaction agreements with Medtronic could be less beneficial than the terms we may have otherwise received from unaffiliated third parties.”

The Divestment

Upon completion of this offering, Medtronic will continue to own at least 80.1% of the voting power of our shares of common stock eligible to vote in the election of our directors. Medtronic has informed us that, following the completion of this offering, it intends to make a generally tax-free distribution to its shareholders of all or a portion of its remaining equity interest in us, which may be structured as a spin-off, in which Medtronic would make a pro rata distribution of our common stock to all Medtronic shareholders, or a split-off, in which Medtronic would effect an exchange of Medtronic shares for shares of our common stock, or any combination thereof. We refer to these options collectively as the “Divestment.”

Medtronic has agreed not to effect the Divestment for a period of 180 days after the date of this prospectus without the prior written consent of each of Goldman Sachs & Co. LLC and BofA Securities, Inc. See “Underwriting.” While, as of the date of this prospectus, Medtronic intends to effect the Divestment, Medtronic has no obligation to pursue or consummate any further dispositions of its equity interest in our company, including through the Divestment, by any specified date or at all. If pursued, the Divestment may be subject to a number of conditions, including the receipt of any necessary regulatory or other approvals, the existence of satisfactory market conditions, the receipt of the Tax Opinions, and Medtronic having sufficient distributable reserves to effect the Divestment. The conditions to the Divestment may not be satisfied, Medtronic may decide not to consummate the Divestment even if the conditions are satisfied, or Medtronic may decide to waive one or more of the conditions and consummate the Divestment even if all of the conditions are not satisfied.

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UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

The following unaudited pro forma condensed combined financial statements give effect to the Separation and related adjustments in accordance with Article 11 of the SEC’s Regulation S-X, as amended. The Separation and related transactions are described in the section of this prospectus entitled “The Separation and Divestment Transactions—The Separation.”

The unaudited pro forma condensed combined financial statements have been derived from our historical unaudited condensed combined statement of loss for the six months ended October 24, 2025, our historical audited combined statement of loss for the fiscal year ended April 25, 2025, and our historical unaudited combined balance sheet at October 24, 2025. The pro forma adjustments to the unaudited pro forma condensed combined statement of operations for the six months ended October 24, 2025 and for the fiscal year ended April 25, 2025 assume that the Separation and related transactions occurred as of April 27, 2024, which was the first day of fiscal year 2025. The unaudited pro forma condensed combined balance sheet gives effect to the Separation and related transactions as if they had occurred on October 24, 2025, our latest balance sheet date.

The unaudited pro forma condensed combined financial statements have been prepared to include transaction accounting and autonomous entity adjustments to reflect the financial condition and results of operations as if we were a separate standalone entity. In addition, management’s adjustments, presented in the accompanying notes to the unaudited pro forma condensed combined financial statements, provide supplemental information to understand the synergies and dis-synergies that are expected to result from the Separation.

“Transaction Adjustments” will be comprised of the “Capitalization Adjustments” and “Separation Adjustments” described below.

Capitalization Adjustments include the following:

•the effect of our anticipated post-Separation capital structure, consisting of the sale of 28,000,000 shares of our common stock in this offering and the application of the net proceeds from this offering as described in the section of this prospectus entitled “Use of Proceeds,” based on an assumed initial public offering price of $26.50 per share of our common stock, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us; and

•the Company has entered into a Revolving Credit Facility (as defined in the section of this prospectus entitled “Description of Certain Indebtedness”) in connection with the Separation, the balance of which will remain undrawn as of the Separation date. Capitalized issuance costs are not expected to be material.

Separation Adjustments include the following:

•differences between our historical combined balance sheet prepared on a carve-out basis and assets and liabilities expected to be retained by Medtronic or contributed to us in connection with the Separation Agreement;

•the impact of the Tax Matters Agreement to be entered into with Medtronic in connection with the Separation;

•non-recurring expenses associated with the Separation and related transactions; and

•other adjustments as described in the accompanying notes to the unaudited pro forma condensed combined financial statements.

Autonomous Entity Adjustments include the following:

•the impact of the Transition Services Agreement to be entered into with Medtronic in connection with the Separation which is described under “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation”; and

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•other adjustments as described in the accompanying notes to the unaudited pro forma condensed combined financial statements.

A final determination regarding our capital structure has not yet been made, and the Separation Agreement, Transition Services Agreement, Tax Matters Agreement, and certain other transaction agreements have not been finalized. As such, the pro forma statements may be revised in future amendments to this prospectus to reflect the impact on our capital structure and the final form of those agreements, to the extent any such revisions would be deemed material.

The unaudited pro forma condensed combined financial statements were prepared in accordance with Article 11 of Regulation S-X. The unaudited pro forma condensed combined financial statements are presented for informational purposes only and do not purport to represent what our financial condition and results of operations actually would have been had the Separation occurred on the dates indicated, or to project our financial performance for any future period. The unaudited pro forma condensed combined financial statements are based upon available information and assumptions that we believe are reasonable and supportable.

Our historical combined financial statements, which were the basis for the unaudited pro forma condensed combined financial statements, were prepared on a carve-out basis as we did not operate as a standalone entity for the periods presented. Accordingly, such financial information reflects an allocation of certain corporate costs, such as finance, supply chain, human resources, information technology, insurance, employee benefits, and other expenses that are either specifically identifiable or clearly applicable to the Diabetes Operating Unit. The historical combined financial statements may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during the periods presented, or what our financial condition, results of operations, and cash flows may be in the future.

The unaudited pro forma condensed combined financial information reported below should be read in conjunction with the section of this prospectus entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the historical combined financial statements included elsewhere in this prospectus.

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UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

As of October 24, 2025

(Dollars in Millions)


			Transaction Adjustments
(in millions)	Historical		Capitalization Adjustments			Separation Adjustments			Autonomous Entity Adjustments		Pro Forma
ASSETS
Current assets
Cash and cash equivalents	$	8	$	342	a						$	350
Accounts receivable, less allowances and credit losses	588					(422)		c			166
Inventories	361										361
Other current assets	33					(20)		c			13
Total current assets	991		342			(442)			—		891
Property, plant, and equipment, net	755										755
Goodwill	2,256										2,256
Other intangible assets, net	119										119
Tax assets	19					45		f			64
Other assets	149					1		c,e			150
Total assets	$	4,289	$	342		$	(396)		$	—	$	4,235
LIABILITIES AND EQUITY
Current liabilities
Accounts payable	$	242				$	(113)	c			$	129
Accrued compensation	152					(58)		c,b			94
Accrued rebates	49										49
Other accrued expenses	117					(38)		c			79
Total current liabilities	560		—			(210)			—		350
Other liabilities	170					(30)		c,e			140
Total liabilities	729		—			(239)			—		490
Commitments and contingencies
Equity
Common stock - par value $0.01 per share (1,000,000,000 authorized shares; 280,813,348 issued shares)			3		a						3
Net investment from Parent	3,551					(3,551)		d			—
Additional paid-in capital			339		a	3,399		c,d,f			3,738
Accumulated deficit						(5)		b			(5)
Accumulated other comprehensive income	8										8
Total parent company equity	3,560		342			(157)			—		3,745
Total liabilities and equity	$	4,289	$	342		$	(396)		$	—	$	4,235

See accompanying Notes to Unaudited Pro Forma Condensed Combined Financial Statements.

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UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS

For the six months ended October 24, 2025

(Dollars in Millions, except per share amounts)


			Transaction Adjustments
(in millions)	Historical		Capitalization Adjustments		Separation Adjustments			Autonomous Entity Adjustments			Pro Forma
Net sales	$	1,475									$	1,475
Cost of products sold	637							1		h	638
Gross profit	838							(1)			837
Operating Expenses:
Research and development expense	236										236
Selling, general, and administrative expenses	575							26		h,j	601
Certain litigation charges	17										17
Other operating expense (income), net	7										7
Operating profit (loss)	3		—		—			(27)			(24)
Other non-operating expense, net	1										1
Profit (loss) before income taxes	2		—		—			(27)			(25)
Income tax provision	23							(1)		i	22
Net loss	(21)		$	—	—			(25)			(46)
Net income attributable to noncontrolling interests	(8)				8		g				—
Net loss attributable to Diabetes Business	$	(29)	$	—	$	8		$	(25)		$	(46)
Earnings (loss) per share attributable to common shareholders — basic and diluted											$	(0.17)	k
Weighted average common shares outstanding — basic and diluted											280,813,348		k

See accompanying Notes to Unaudited Pro Forma Condensed Combined Financial Statements.

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For the fiscal year ended April 25, 2025

(Dollars in Millions, except per share amounts)


			Transaction Adjustments
(in millions)	Historical		Capitalization Adjustments		Separation Adjustments			Autonomous Entity Adjustments			Pro Forma
Net sales	$	2,715									$	2,715
Cost of products sold	1,187							3		h	1,190
Gross profit	1,528							(3)			1,525
Operating Expenses:
Research and development expense	436							2		h	438
Selling, general, and administrative expenses	1,080				5		b	46		h,j	1,131
Certain litigation charges	165										165
Other operating (income) expense, net	(8)										(8)
Operating loss	(146)		—		(5)			(51)			(202)
Other non-operating expense, net	1										1
Loss before income taxes	(147)		—		(5)			(51)			(203)
Income tax provision	52				(1)		f	(3)		i	48
Net loss	(198)		$	—	(4)			(48)			(250)
Net income attributable to noncontrolling interests	(15)				15		g				—
Net loss attributable to Diabetes Business	$	(213)	$	—	$	11		$	(48)		$	(250)
Earnings (loss) per share attributable to common shareholders — basic and diluted											$	(0.89)	k
Weighted average common shares outstanding — basic and diluted											280,813,348		k

See accompanying Notes to Unaudited Pro Forma Condensed Combined Financial Statements.

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Notes to Unaudited Pro Forma Condensed Combined Financial Statements

Capitalization Adjustments

(a)Reflects the receipt of approximately $342 million of net proceeds associated with the sale of shares of common stock in this offering at the assumed initial public offering price of $26.50 per share, which is the midpoint of the estimated public offering price range set forth on the cover page of this prospectus, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, and further reduced by part of the net proceeds of the offering remitted to Medtronic on the offering date to settle intercompany debt between Medtronic and the Company. The intercompany debt is assumed to be issued immediately prior to the offering date, and settled on the offering date. After giving effect to the offering and the settlement of intercompany debt, we expect to retain an amount in cash and cash equivalents estimated to be $350 million.

Separation Adjustments

(b)Reflects an adjustment of $5 million for employee retention bonuses estimated to be accrued as of the completion of this offering.

(c)Reflects an adjustment for certain assets and liabilities that will be retained by Medtronic or transferred to us in connection with the Separation, exclusive of impacts on deferred tax assets and liabilities which are separately reflected in adjustment (f). The difference between these assets and liabilities has been recorded to additional paid-in capital. Refer to the table below for further details.


(Dollars in Millions)	As of October 24, 2025
Accounts receivable, net of allowance for bad debts	$	(422)
Other current assets	(20)
Other assets	(9)
Accounts payable	(113)
Accrued compensation	(63)
Other accrued expenses	(38)
Other liabilities	(40)

(d)Reflects the reclassification of Medtronic’s net investment in us to common stock and additional paid-in capital.

(e)Reflects the establishment of an indemnification asset of $10 million in Other assets and a $10 million uncertain tax position liability in Other liabilities that is expected to be established by the Company pursuant to the Tax Matters Agreement. The amount of such indemnifications is still preliminary and will be finalized prior to the Separation.

(f)Reflects the tax effects of the separation accounting adjustments at the applicable statutory income tax rates. The applicable tax rate could be impacted (either higher or lower) depending on many factors subsequent to the Separation, including the profitability in local jurisdictions, the tax deductibility of retention bonuses, and the legal entity structure implemented subsequent to the Separation and may be materially different from the pro forma results. Additionally, the adjustment includes:

•A decrease in deferred tax assets of $8 million associated with tax attributes that will be retained by Medtronic.

•The addition of deferred income tax assets of $53 million resulting from the anticipated adjustments to the tax basis in certain assets and liabilities resulting from legal entity restructuring in connection with the Separation. These tax basis adjustments and resulting additional deferred tax assets are based on

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our latest estimation of related assets and liabilities, which have not yet been completed. We expect to finalize such valuations at the completion of the Separation.

(g)Reflects the removal of allocated noncontrolling interest associated with a joint venture arrangement which will be retained by Medtronic as part of the Separation.

Autonomous Entity Adjustments

(h)Reflects the incremental costs to be incurred in connection with the Transition Services Agreement we will enter into with Medtronic. Refer to the table below for further details.


(Dollars in Millions)	For the six months ended October 24, 2025		For the year ended April 25, 2025
Cost of products sold	$	1	$	3
Selling, general, and administrative expenses	9		17
Research and development expense	—		2

(i)Reflects the tax impacts of the autonomous entity adjustments after applying transfer pricing and the applicable statutory income tax rates to pre-tax pro forma adjustments in jurisdictions where valuation allowances are not necessary. The adjustment considers transfer pricing arrangements in place related to the jurisdictional place of supply. The applicable tax rates could be impacted (either higher or lower) depending on many factors subsequent to the Separation including the profitability in local jurisdictions and the legal entity structure implemented subsequent to the Separation and may be materially different from the pro forma results.

(j)Reflects incremental costs to be incurred in connection with other Separation-related agreements we will enter into with Medtronic. An adjustment of $29 million has been reflected for the year ended April 25, 2025 and an adjustment of $17 million has been reflected for the six months ended October 24, 2025.

Pro Forma Earnings Per Share

(k)Pro forma basic and diluted net loss per share and pro forma weighted-average number of common shares outstanding have been computed based on the number of shares of our common stock expected to be outstanding upon completion of this offering and the subsequent pattern of vesting for equity awards expected to be issued as replacement awards to Medtronic employees transferring to our Company. As the Company has a loss in the unaudited pro forma condensed combined statement of operations for the six months ended October 24, 2025, and the year ended April 25, 2025, equity awards with potential dilutive impact to EPS were excluded from the computation of diluted EPS as they would be anti-dilutive. Anti-dilutive shares excluded from the computation of diluted EPS consist of 2.8 million restricted stock units.

Management Adjustments

We expect to realize changes in our cost structure as a standalone public company related to certain expenses previously allocated from Medtronic. Our historical combined financial statements include allocations for certain costs of support functions that are provided on a centralized or geographic basis by Medtronic and its affiliates, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate strategy, corporate governance, and other professional services and general commercial support functions.

These cost structure changes are based on our expected organization chart and expected cost structure as a standalone company, adjusted for the allocated costs recorded within our historical combined financial statements, which vary by year. In order to determine anticipated impact of cost structure changes, we prepared a detailed assessment of the internal resources and associated costs required as a baseline to stand up the Company on a standalone basis. In addition to these internal resources, third-party support costs in each function were considered, which included business support functions and corporate overhead charges previously shared with Medtronic. This

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process was used by all functions, resulting in cost synergies compared to the corporate allocations reflected in our historical combined financial statements.

Any shortfall of required resource needs have been or will be filled through external hiring or will be supported by Medtronic through transition services for a limited duration following the Separation. From a timeframe standpoint, we expect that the estimated synergies will begin to materialize upon the completion of this offering. Management believes the resource transfers and costs which were used as the basis for the management adjustments below are reasonable and representative of the baseline to stand up the Company as a standalone company. Both the resource and vendor cost baseline would be impacted by additional costs and investments that we may incur as we pursue our growth strategies. In addition, other adverse effects and limitations, including those discussed in the section of this prospectus entitled “Risk Factors,” may impact actual costs incurred.

The estimated cost synergies are presented as “Management Adjustments” within the table below and reflect estimated one-time and non-recurring costs of $29 million and $47 million for the six months ended October 24, 2025, and the year ended April 25, 2025, respectively, as if the separation had occurred on the first day of fiscal year 2025. These estimated one-time and non-recurring costs are related to IT systems implementation, advisory services, contract realignment, and other transitional activities, which are separate from, and in addition to, the transaction accounting adjustments and autonomous entity adjustments already reflected in the pro forma financial statements. These management adjustments are not expected to result in any change to the number of shares or potential common shares to be issued as part of the offering.

Management believes the presentation of these adjustments is necessary to enhance an understanding of the pro forma effects of the transaction. The pro forma financial information below reflects all adjustments that are, in the opinion of management, necessary to provide a fair statement of the pro forma financial information, aligned with the assessment described above. If we decide to increase or reduce resources or invest more heavily in certain areas in the future, that will be part of our future decisions and has not been included in the management adjustments below. The tax effect has been determined by applying the applicable statutory income tax rates to pre-tax pro forma adjustments in jurisdictions where valuation allowances are not necessary. The adjustment considers transfer pricing arrangements in place related to the jurisdictional place of supply. The applicable tax rates could be impacted (either higher or lower) depending on many factors subsequent to the Separation including the profitability in local jurisdictions and the legal entity structure implemented subsequent to the Separation and may be materially different from pro forma results.

These management adjustments include forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements.”


	For the six months ended October 24, 2025
(Dollars in Millions, except per share amounts)	Pro forma net income (loss)		Pro forma basic earnings (loss) per share		Pro forma diluted earnings (loss) per share
Unaudited pro forma net loss	$	(46)	$	(0.17)	$	(0.17)
Management adjustments	49
Tax effect of Management adjustments	(3)
Total Management adjustments, net of tax	$	46
Pro forma net income after Management adjustments	$	1	$	0.01	$	0.01

Weighted average common shares outstanding – basic and diluted			280,813,348		280,813,348

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	For the year ended April 25, 2025
(Dollars in Millions, except per share amounts)	Pro forma net loss		Pro forma basic loss per share		Pro forma diluted loss per share
Unaudited pro forma net loss	$	(250)	$	(0.89)	$	(0.89)
Management adjustments	78
Tax effect of Management adjustments	(4)
Total Management adjustments, net of tax	$	73
Pro forma net loss after Management adjustments	$	(176)	$	(0.63)	$	(0.63)

Weighted average common shares outstanding – basic and diluted			280,813,348		280,813,348

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with the audited combined financial statements as of April 25, 2025 and April 26, 2024 and for the years ended April 25, 2025 (fiscal year 2025), April 26, 2024 (fiscal year 2024), and April 28, 2023 (fiscal year 2023), as well as with the unaudited condensed combined financial statements as of October 24, 2025 and for the six months ended October 24, 2025 and October 25, 2024, in each case together with related notes thereto, included elsewhere in this prospectus. The discussion and analysis should also be read together with the sections of this prospectus entitled “Business,” “Risk Factors,” and “Unaudited Pro Forma Condensed Combined Financial Statements.” The following discussion contains forward-looking statements that reflect future plans, estimates, beliefs, and expected performance. The forward-looking statements are dependent upon events, risks, and uncertainties that may be outside of the Company’s control. Our actual results may differ significantly from those projected in the forward-looking statements. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those discussed in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” included elsewhere in this prospectus.

Overview

We are a scaled global medical technology company that develops, manufactures, and markets a comprehensive suite of solutions for the management of diabetes. Our fully integrated system addresses two key pain points for PWD: health outcomes and complexity of diabetes management. Our systems have consistently delivered superior clinical outcomes across diabetes populations, with a robust body of controlled studies as well as real-world outcomes supporting our ability to improve glycemic control when compared to competing Smart Dosing systems as well as traditional therapy treatment options. We address complexity by offering a simple solution and customer experience that removes some of the constant administrative, physical, mental, and emotional burdens associated with managing diabetes. Altogether, our products deliver a better quality of life for PWD. This has been our focus since launching our first-generation MiniMed 670G hybrid closed-loop system in 2016, and continues today as we develop our third-generation AID systems.

Historically, we have derived our revenues from the sale of both reusable products and single-use products which together comprise our AID systems and Smart MDI systems. For the six months ended October 24, 2025 and fiscal year 2025, approximately 70% of our business in the United States shipped directly to patients, versus approximately 30% indirect with distributor partners. Outside of the United States, the diabetes market is highly varied, with nuanced differences in sales process and country-specific factors like tenders, vendor rankings for access, and varying levels of government involvement in procurement, fulfillment, and reimbursement.

The MiniMed 780G is our flagship AID system, which consists of the following components: the MiniMed 780G insulin pump, our second-generation insulin pump offering enhanced functionality and technological integration with other components of our 780G system; the Simplera Sync or Instinct CGM sensor, which are both easy-to-use, fully disposable, two-step insertion sensors; and our SmartGuard dosing algorithm technology, which automatically delivers basal insulin and auto-correction doses every five minutes based on sensor glucose readings and adapts to ongoing changes in user behavior patterns every night. For PWD that choose to manage their diabetes with MDI instead of an insulin pump, we offer our Smart MDI system. Smart MDI helps limit the guesswork typically required for manual insulin dosing to help PWD deliver the appropriate dose at the appropriate time and improve health outcomes relative to patients who only use a CGM sensor.

Among leading diabetes device manufacturers as identified by Seagrove Partners, we have the largest global footprint in our industry, operating in approximately 80 countries, a well-invested, global, and experienced employee base of approximately 8,000 dedicated employees globally, including over 3,000 commercial employees, and two world-class dedicated manufacturing facilities. We expect our scaled global infrastructure will play an important part in our financial profile, and we expect it to provide substantial operating leverage as we grow. Over our years of operation, we have developed a deep understanding of each of our markets’ unique local dynamics to optimize our commercial approach, adapting our selling motion to a variety of payment schemes, varying constraints on our marketing activity, and differing levels of government and private payor involvement country-to-country. We

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have experience navigating numerous distinct local regulatory and reimbursement regimes and have made a significant level of upfront investment that is required to establish footholds in our markets.

We have a 40+ year history of demonstrated excellence in innovation. We are committed to making material contributions to improving the lives of PWD through industry-defining inventions, including the first insulin pump with mass-market appeal and usability, the first physician-use CGM system, and the first hybrid closed-loop pump system. We support our innovation mission with a strong base of scientific, engineering, and regulatory expertise. Leading our efforts are over 1,100 research and development professionals who bring a diversity of skills across electrochemistry, electronics, mechanical engineering, software, data science and AI, and consumer electronics and valuable experience in the diabetes space. Our multi-disciplinary capabilities in research and development, underscored by our deep clinical experience, enable our business to develop breakthrough innovative solutions for PWD.

We plan to continue to drive adoption of AID across our addressable market and additional population segments. In our current addressable market, we are driving sales of our MiniMed 780G system by communicating its clinical efficacy and customer experience benefits to PWD and prescribing HCPs. We plan for this system to provide our customers with much greater choice for AID treatment using new technologies across insulin administration, CGM, and dosing algorithm technologies, in one unified platform and one consistent application for user and HCP experience, all while further reducing patient burdens significantly and raising the bar for clinical outcomes. We also have an opportunity to grow the addressable market for MiniMed 780G through expanded indication labeling. For example, in fiscal year 2026, we received U.S. FDA and CE Mark approval for use of the MiniMed 780G system by insulin-requiring T2D patients. We believe the insulin-requiring T2D population is vastly underpenetrated around the world and well-suited for the MiniMed 780G system. In addition to AID, we plan to leverage our algorithm and dosing expertise to drive adoption of our current Smart MDI system generation. As with our AID strategy, we plan to continue to drive uptake through our dedicated commercial functions across our markets.

We also aim to accelerate growth through strategic partnerships and tuck-in acquisitions that complement our organic initiatives. As part of this strategy, we expect to continue to pursue attractive strategic collaboration opportunities, such as our partnership with Abbott to expand CGM choice and access to our AID and Smart MDI systems.

See “Business” for a more detailed description of our business.

Separation from Medtronic

On May 21, 2025, Medtronic, our parent company, announced its intention to separate its Diabetes Operating Unit. We were incorporated in Delaware on February 27, 2025 in connection with the Separation and were formed to ultimately hold, directly or indirectly, and conduct certain operational activities in anticipation of the planned separation of, the Diabetes Operating Unit. We are incurring certain costs in connection with our establishment as a standalone public company. We expect that we will continue to bear separation-related costs, as described in “The Separation and Divestment Transactions—The Separation” and “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation.”

Relationship with Medtronic

In connection with the Separation and prior to the completion of this offering, we will enter into the Separation Agreement and various other agreements with Medtronic, which, together with the Separation Agreement, provide for certain transactions to effect the transfer of the assets and liabilities of the Diabetes Operating Unit to us and will result in the separation of our business from Medtronic. In addition, these agreements will collectively govern various interim and ongoing relationships between us and Medtronic following the completion of this offering. These agreements with Medtronic are described in the section of this prospectus entitled “Certain Relationships and Related Person Transactions—Agreements to be Entered into in Connection with the Separation.”

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Recent Developments

Simplera CGM Approval

In August 2024, we received U.S. FDA approval for our Simplera CGM. Simplera is our first disposable, all-in-one CGM that is approximately half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wear experience, lessening the need for overtape.

The Simplera platform featuring our newest CGM form factor includes the Simplera CGM and is designed to be used as part of a Smart MDI system with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be used with the MiniMed 780G system. The Simplera Sync sensor was approved by the U.S. FDA in April 2025.

InPen App Receives U.S. FDA Clearance

In November 2024, we announced that the InPen app received U.S. FDA clearance. This clearance paves the way for the launch of the Smart MDI system with the Simplera CGM, combining the InPen smart insulin pen with the newest Simplera CGM.

Approval to Use the MiniMed 780G System in Insulin-Requiring Type 2 Diabetes

In July 2025, we received CE Mark approval of the MiniMed 780G system for use by patients aged two years and older, during pregnancy, as well as those with insulin-requiring T2D. In September 2025, we also received U.S. FDA approval of the MiniMed 780G system for use by patients with insulin-requiring T2D. We believe the insulin-requiring T2D population is vastly underpenetrated around the world and well-suited for the MiniMed 780G system.

Global Partnership with Abbott to Complement CGM Offerings

In August 2024, we announced a global partnership with Abbott to enhance our CGM offerings for PWD. Under this agreement, Abbott is expected to supply us with Instinct, an alternative CGM sensor based on Abbott’s most advanced single-analyte CGM technology, and will be the exclusive supplier of third-party CGMs for certain of our AID and Smart MDI systems. These systems are designed to ensure seamless integration with Instinct. We believe integrating Instinct into our AID and Smart MDI systems allows us to expand access for PWD by combining our advanced insulin dosing systems with the most widely used CGM technology in the world.

In July 2025, we received U.S. FDA clearance of our MiniMed 780G as an ACE pump. In September 2025, we received U.S. FDA clearance of our SmartGuard algorithm as an iAGC. These clearances enable compatibility between the MiniMed 780G system and Instinct. Instinct is exclusively integrated with MiniMed devices and algorithms and is based on an Abbott CGM that has U.S. FDA and CE Mark approval. The combined solution of Instinct with MiniMed 780G as an integrated system creates a new product offering that expands treatment options for MiniMed users and provides greater customer choice and flexibility.

Key Factors Impacting Our Results

We believe our future performance will be influenced by a number of factors, including those described in the section of this prospectus entitled “Risk Factors” and elsewhere in this prospectus as well as the factors described below. While each of these factors presents significant opportunities for us, these factors also pose challenges that we must successfully address in order to sustain the growth of our business and enhance our results of operations.

Industry Trends

We believe the main driver of our market’s expected rate of growth is increased penetration of Smart Dosing solutions, such as AID, over traditional therapies like unconnected MDI or standalone CGMs. They are becoming the gold standard of care in our space because of their proven ability to improve clinical outcomes and reduce user burden.

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We believe that the adoption of these Smart Dosing technologies has room for growth. While some existing products may be seen as complex, costly, and not meaningfully more effective than alternatives, this opens the door for innovation to enhance these technologies in ways to better serve PWD and HCPs who prescribe these devices.

Additional secular drivers may also contribute to the growth of our addressable population. Our market exhibits many of the same secular growth drivers as the broader disease population, including prevalence of Western diets and healthcare development in emerging markets.

CGM Pricing Pressure

We have observed increasing pricing pressure on CGMs globally, particularly in certain international markets. Differences in reimbursement and pricing dynamics across geographies and sales channels can result in variability in average selling prices and gross margins, particularly as changes in sales mix occur. Additionally, as competition in the CGM market intensifies, lower-cost CGM options in the market may contribute to further pricing pressure over time. We are focused on continuing to invest in our pipeline to deliver differentiated solutions that reinforce our competitive positioning and our long-term growth.

Product Launches and Investment in Pipeline

We believe the success of our products correlates to the continued acceptance and growth of our product offerings, such as the MiniMed 780G system, next-generation AID systems, and Smart MDI systems. Our ability to meet growing demand for our existing products and to successfully develop, obtain regulatory approval or clearance of, and commercialize the products within our pipeline is essential to our results of operations. Timing and successful launch of partnerships such as our agreement with Abbott may also contribute meaningfully to our go-forward market performance.

The ability to sustain ongoing investment in our pipeline will be required as we progress towards developing and launching our next generation of products. We strive to develop ways in which we can make our research and development process as efficient as possible and reduce the amount of investment needed to progress a product to approval.

Users, New Patient Adoption, and Sales of CGMs and Other Consumables

Our strategy also relies on our ability to maintain and grow our existing base of users that utilize our insulin pumps and smart pens. We consider this to be a function of multiple priorities.

First, we seek to maintain our core base of existing users. We do this by offering attractive warranty terms for insulin pumps, typically over a four-year period, and differentiated customer service. In addition, we communicate often with our existing users and their providers about our innovative products to drive continued preference. This encourages users to continue utilizing our offerings and, for insulin pump users, often leads to the renewal of their warranty arrangements.

Second, we seek to add users by winning share of new patients. We do this through our various commercial efforts and new product introductions, targeting three main pools of patients who may adopt our products: (1) patients utilizing other treatment options, such as MDI, (2) patients using competitor pumps, often those reaching the end of their pump warranty periods, and (3) patients new to insulin therapy. As the rate of sales of our products to new patients has impacted our financial performance, and will continue to do so in the future, we monitor and evaluate our performance on the share of new patients that we are winning from these various groups. “New Pumps Sold” are a key indicator of our current business success, and we anticipate that this metric will grow as we increase our market share in existing markets and expand into emerging ones.

Into this growing base of insulin pump and smart pen users, we sell an assortment of consumable companion products, such as CGMs and infusion sets. We track the attachment rate of our CGM sensors to evaluate how often a pump user chooses to utilize our full ecosystem of technology solutions. Since our CGM sensors are compatible with our pump dosing algorithm and Smart MDI dosing applications, we expect a relatively stronger rate of adoption among our user base. Sensor performance and user preference can have an impact on this attachment rate, and we

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find in the months since launching our newest-generation Simplera Sync sensor that we are exhibiting higher attachment rates than we have historically.

Competition

The diabetes medical device industry is highly competitive and constantly evolving, especially with the rapid introduction of competing pumps, CGMs, and other consumables in an expanding global market. We anticipate that new diabetes devices and treatments from both us and our competitors will impact our business. The Smart MDI market is also evolving, with increasing competition from new entrants and expanding digital health integrations, which may impact our positioning and growth opportunities in this segment. To maintain our competitive edge in the market, we plan to continue investing in innovative technologies, such as the MiniMed Go, our next-generation MDI system with single app integration; the MiniMed Flex, our smaller, screenless, newly designed insulin pump; the MiniMed Fit patch pump; and our next-generation Vivera dosing algorithm. Additionally, we are focused on expanding the adoption of AID across our addressable market for a broader range of patient populations as well as growing the addressable market for MiniMed 780G through expanded indication labeling.

Regulatory Approvals and Actions

The medical devices we manufacture are subject to extensive regulation by numerous government agencies, including the U.S. FDA, the EU MDR, and various other individual country regulatory bodies and agencies. To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, distribution, and post-market surveillance of our products. The requirements and timelines to receive regulatory clearance can vary substantially from country to country, and any delays may impact our ability to expand our worldwide customer base and bring products to market in a competitive timeframe. Such delays, or a failure to receive regulatory approval, could adversely affect our revenue and results of operations.

Additionally, any adverse event involving products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency actions, which may include inspections, mandatory recalls, or other enforcement measures. Any action taken by regulatory bodies against us, along with any regulatory challenges we encounter, could negatively impact our product sales.

See “Business—Government Regulation and Product Approval Process” for a more detailed description of regulations and approval processes relevant to our business.

Manufacturing and Supply

Our business model requires the ability to produce high volumes of our products and reliably ship to various geographies in a time-efficient manner. Disruptions to our supply lines or shipping channels may impact our customer experience and ability to meet market demand. We also continue to invest in expanding our manufacturing capacity as a key strategic priority of our business as we strive to meet significant demand for our CGM sensors and drive profitable growth.

Impact of Increased CGM Share of Product Mix on Profit Margin

Relative to sales of our insulin pumps, pens, and other consumables, sales of our CGMs, particularly our Simplera and Simplera Sync products, have historically contributed to a lower profit margin. As a result, we expect that an increased volume of sales with Simplera and Simplera Sync will likely have a negative impact on our profit margin, as we have observed in recent periods. However, as we continue to ramp our manufacturing capacity to meet demand, we are focused on optimizing manufacturing efficiencies, driving innovation, and expanding premium offerings to help offset expected margin impacts while sustaining growth.

Foreign Exchange Rate

A significant portion of our revenues and costs are exposed to changes in foreign exchange rates. We operate in approximately 80 countries and about 70% of our revenues during the six months ended October 24, 2025 and 67%, 66%, and 63% of our revenues in fiscal years 2025, 2024, and 2023, respectively, were denominated in foreign

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currencies. We actively manage risk related to our exposure to fluctuations in foreign exchange rates to minimize the impact on our business.

Seasonality

Our total revenues vary slightly from quarter to quarter. Based on historical experience, we generally have higher revenues toward calendar year end and lower sales in the first calendar months of the following year. The trend is primarily driven by annual insurance deductible resets and unfunded flexible spending account dynamics in the U.S. market, which is partially counteracted by lower pump sales as our competitors push for a strong end to their fiscal years, which align to calendar years. Sales of our single-use products such as infusion sets, reservoirs, and CGMs have generally mitigated quarterly seasonal fluctuations in pump sales.

Reimbursement

Our results of operations may be impacted by the failure to obtain or retain sufficient coverage from third-party payors for our current and future products as well as changes in medical reimbursement policies and programs.

Our reimbursement channel expertise and deep relationships with payors and providers represent a key part of our business strategy, driving revenue stickiness, differentiation, and scale. Changes in the nature of these relationships or reimbursement policies around channel categorization (for example, DME or pharmacy) can materially impact our business. For more information on channel categorization, see “Business—Our Commercial Organization.”

Cost Reduction Measures

We expect our future financial results will be impacted by the degree to which we are able to execute on efficiency initiatives. We expect these initiatives to contribute to our go-forward profit margins and are a part of our Ways of Working transformation in recent years. For more information on our Ways of Working, see “Business—People and Culture.” As part of these initiatives, we aim to find savings in variable and overhead costs in our Cost of Products Sold and other operating expenses. In addition, we are focused on developing high-volume and automated manufacturing capabilities to continue to optimize our cost base.

Macroeconomic and Geopolitical Factors

Our costs are subject to fluctuation, and we continue to evaluate contributing factors, specifically those leading to inflationary cost increases in logistics, price of raw materials, cost of labor, transportation, and operating supplies. Global macroeconomic risks include changes in global trade policies and fluctuations in currency exchange rates, general price inflation, changes in interest rates, reimbursement challenges, impacts from changes in the mix of our product offerings, delays in product registration approvals, replacement cycle challenges, supply chain challenges, and tender pricing in certain countries.

Our production of certain products requires custom components that are sourced internationally. We do not currently anticipate tariffs imposed by the United States to significantly impact our manufacturing operations due to the duty-free treatment offered by the Nairobi Protocol, which provides duty-free treatment for items that benefit handicapped persons. While the extent of the tariffs levied by the United States remains uncertain, recent government actions have not limited the use of the Nairobi Protocol.

Key Business Metrics

We regularly review the following key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. In assessing the performance of our business, in addition to considering a variety of measures in accordance with U.S. GAAP, we also consider a variety of other key business metrics, including non-GAAP measures.

We believe that these key business metrics provide useful information to users of our financial statements in understanding and evaluating our results of operations in the same manner as our management team. The presentation of these key business metrics, including Organic Revenue Growth, Adjusted Gross Profit, and Adjusted

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EBITDA, which are non-GAAP financial measures, is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with U.S. GAAP. See “—Non-GAAP Measures” below.

The following table sets forth our key business metrics, including non-GAAP measures, for the periods indicated:


	Six months ended						Fiscal Year
(Dollars in millions)	October 24, 2025			October 25, 2024			2025			2024			2023
Net Sales	$	1,475		$	1,304		$	2,715		$	2,469		$	2,245
Gross Profit	$	838		$	728		$	1,528		$	1,436		$	1,308
Net Loss	$	(21)		$	(23)		$	(198)		$	(107)		$	(92)
New Pumps Sold	64,037			65,448			145,294			143,318			133,738
Global CGM Attachment Rate	65		%	58		%	59		%	52		%	46		%
Net Sales Growth	13.1		%	n/a			10.0		%	10.0		%	n/a
Organic Revenue Growth (1)	7.4		%	n/a			11.5		%	8.6		%	n/a
Adjusted Gross Profit (1)	$	843		$	761		$	1,573		$	1,463		$	1,341
Adjusted EBITDA(1)	$	128		$	97		$	253		$	147		$	136

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(1)See “—Non-GAAP Measures” below for a discussion of Organic Revenue Growth, Adjusted Gross Profit and Adjusted EBITDA and a reconciliation with the most directly comparable U.S. GAAP measure.

Gross Profit

Gross profit is our net sales, less cost of products sold.

New Pumps Sold

A leading indicator of our pump user base growth is the number of new pumps sold. We define New Pumps Sold (“NPS”) as the number of new pumps sold to patients in a given period, inclusive of pumps sold to new patients and renewals by existing patients. This metric illustrates the number of new pump starts and renewals during each period presented, highlighting our capability to identify, attract, and retain users.

Global CGM Attachment Rate

As the only company that commercializes all parts of the smart dosing insulin therapy ecosystem, we are uniquely positioned to capture greater revenue per user than our competitors that only offer certain components of such systems. A key growth driver is our ability to increase CGM revenue per pump user which is reflected by our CGM Attachment Rate. We define CGM Attachment Rate as the percentage of total pump user base that is also using an integrated MiniMed CGM.

Organic Revenue Growth

Organic Revenue Growth measures our revenue growth trends excluding the impacts of foreign currency rate fluctuations and adjustments to the Company’s Italian payback accrual for certain prior years since 2015, which is further described in Note 14, “Commitments and Contingencies,” to the audited annual combined financial statements and Note 13, “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus. We use Organic Revenue Growth to assess our performance on a consistent basis by removing the impacts of foreign currency rate fluctuations and adjustments to the Italian payback accrual that we believe do not directly reflect our underlying operations. See “—Non-GAAP Measures” below for a reconciliation of Organic Revenue Growth to Net Sales Growth, its most directly comparable U.S. GAAP measure.

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Adjusted Gross Profit

Adjusted Gross Profit is a non-GAAP measure that we use to assess our overall performance. We define Adjusted Gross Profit as U.S. GAAP gross profit, excluding amortization of intangible assets and certain other non-operational items. We believe Adjusted Gross Profit provides consistency and comparability with our past financial performance and facilitates period-to-period comparisons of operations, as these metrics eliminate the effects of the adjustments that are unrelated to overall operating performance. See “—Non-GAAP Measures” below for a reconciliation of Adjusted Gross Profit to gross profit, its most directly comparable U.S. GAAP measure.

Adjusted EBITDA

Adjusted EBITDA is a non-GAAP measure, calculated as net loss adjusted to exclude interest expense, provision for income taxes, and depreciation and amortization, further adjusted to exclude other non-operational items. We use Adjusted EBITDA to supplement U.S. GAAP measures of performance in the evaluation of the effectiveness of our business strategies, to make budgeting decisions, and to compare our performance against that of other peer companies using similar measures. See “—Non-GAAP Measures” below for a reconciliation of Adjusted EBITDA to net loss, its most directly comparable U.S. GAAP measure.

Results of Operations

Comparison of the six months ended October 24, 2025 and October 25, 2024

The following table sets forth a summary of our combined results of operations for the periods indicated, and the changes between periods.


	Six months ended				Change
(Dollars in millions)	October 24, 2025		October 25, 2024		Amount		Percent
Net sales	$	1,475	$	1,304	$	170	13	%
Cost of products sold	637		577		60		10
Gross profit	838		728		110		15

Operating expenses:
Research and development expense	236		217		19		9
Selling, general, and administrative expenses	575		536		39		7
Certain litigation charges	17		—		17		NM (1)
Other operating expense (income), net	7		(5)		13		NM (1)
Operating profit (loss)	3		(20)		22		(113)
Other non-operating expense, net	1		—		—		12
Profit (loss) before income taxes	2		(20)		22		(110)
Income tax provision	23		3		20		646
Net loss	(21)		(23)		2		(10)
Net income attributable to noncontrolling interests	(8)		(8)		—		5
Net loss attributable to Diabetes Business	$	(29)	$	(31)	$	2	(6	%)

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(1)Not meaningful (NM)

Net sales

Our net sales are generated primarily from the sale of reusable and single-use products which collectively comprise our AID and Smart MDI systems.

Our insulin pumps and pens are considered reusable products as patients are able to continue their use of these products for a period of one year or more. Patients are generally eligible for reimbursement coverage of a new insulin pump every four to five years depending on both geography and payer type. Not all patients elect to replace

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their pump on this cycle and some use their pumps for longer than the replacement period because they can continue to operate as the patient continues to purchase consumables. Patients using durable insulin pens typically obtain replacements on an annual cycle due to reimbursement and product life span.

Our CGMs and the consumable components comprised of infusion sets and reservoirs associated with pumps are considered single-use products as these products are required to be replaced frequently for uninterrupted operation of our AID and Smart MDI systems. Patients using AID systems as well as Smart MDI systems typically replace their sensors on a weekly basis as the Guardian 4 Sensor and Simplera Sync sensors are indicated for up to 7 days of use. Patients using AID systems also replace their infusion sets and reservoirs either weekly or multiple times per week, depending on the type of infusion sets and reservoirs they use.

The below table includes net sales by product category for the six months ended October 24, 2025 and October 25, 2024:


	Six months ended				Change
(Dollars in millions)	October 24, 2025		October 25, 2024		Amount		Percent
Pumps	$	250	$	251	$	(1)	(0.3	%)
Consumables	463		419		44		10.5
CGM	743		639		104		16.3
Other (1)	19		(4)		23		NM (2)
Total	$	1,475	$	1,304	$	170	13.1	%

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(2)Not meaningful

The below table includes net sales by market geography for the six months ended October 24, 2025 and October 25, 2024:


	Six months ended				Change
(Dollars in millions)	October 24, 2025		October 25, 2024		Amount		Percent
U.S. (1)	$	437	$	437	$	(1)	(0.1	%)
International (2)	1,038		867		171		19.7
Total	$	1,475	$	1,304	$	170	13.1	%

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(1)U.S. includes the United States and U.S. territories.

(2)International includes all other non-U.S. countries.

Net sales for the six months ended October 24, 2025 was $1,475 million as compared to $1,304 million for the six months ended October 25, 2024, growing 19.7% internationally and relatively flat in the United States. The net sales growth was primarily driven by increased volumes. The international net sales growth was driven by 11% growth in pumps, 14% growth in consumables, 21% growth in CGM, changes in the Company’s Italian payback accrual, and impacts of foreign currency fluctuations. The sales performance in the United States was driven by a 15% decline in pumps, a 1% decline in consumables, and 8% growth in CGM. For the six months ended October 24, 2025, the impact of the Italian payback adjustment was an increase to net sales of $7 million as compared to a decrease in net sales of $20 million for the six months ended October 25, 2024 due to changes in estimates relating to our Italian payback accrual resulting from the two July 2024 rulings by the Constitutional Court and the Legislative Decree published by the Italian government in June 2025 and formalized into law in August 2025 for

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certain prior years since 2015. Refer to Note 13, “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus.

Pump sales period-over-period were relatively flat. While we experienced continued growth of 11% in international pump sales following the launch of the Simplera CGM in Europe in fiscal year 2025, we experienced an offsetting 15% decline in U.S. pump sales due to the delayed launch of Simplera CGM and increased competition in the United States. The delayed launch of Simplera CGM in the United States resulted in a competitive disadvantage and limited our ability to grow NPS in the first half of fiscal year 2026.

Consumables sales increased 10.5% period-over-period, as a result of 14% growth internationally and 1% decline in the United States. Our international growth was driven by increased volume of patients using our AID systems which require frequent replacement of the infusion sets and reservoirs for uninterrupted operation. The increase in the volume of patients using our AID systems in international markets was due to the competitive strength of the MiniMed 780G system which has enabled us to attract new patients as well as retain our existing patient base. Fewer NPS in the United States resulted in reduced consumables sales in the first half of fiscal year 2026.

CGM sales increased 16.3% period-over-period driven by the continued increase in the CGM Attachment Rate, which rose from 58% in the six months ended October 25, 2024, to 65% in the six months ended October 24, 2025. Higher CGM Attachment Rate and pump user base in international markets drove 21% growth in international CGM sales which was primarily attributable to the introduction of the Simplera CGM in Europe in fiscal year 2025. The Simplera CGM is our first disposable, all-in-one CGM and approximately half the size of previous CGMs. The discreet design simplifies the insertion and wear experience. U.S. CGM sales grew 8% as a result of a sustained upward trend in CGM Attachment Rate. We have experienced a sustained upward trend in CGM Attachment Rate in the United States since the launch of the MiniMed 780G system as the automation algorithm is only compatible with our MiniMed CGMs.

Cost and Expenses

The following is a summary of cost of products sold, research and development, and selling, general, and administrative expenses as a percentage of net sales:


	Six months ended				% of Net Sales
(Dollars in millions)	October 24, 2025		October 25, 2024		October 24, 2025		October 25, 2024
Cost of products sold	$	637	$	577	43.2	%	44.2	%
Research and development expense	236		217		16.0		16.6
Selling, general, and administrative expenses	575		536		39.0		41.1

Cost of products sold

Cost of products sold includes raw materials, labor costs, manufacturing overhead expenses, shipping and handling costs incurred to store, move, and prepare products for shipment, amortization of purchased technology intangible assets, import tariffs and duties, reserves for expected warranty costs, scrap and excess, and obsolete inventory. Manufacturing overhead expenses include expenses relating to manufacturing engineering, material procurement, inventory and quality control, facilities, depreciation, information technology, and operations supervision and management.

Cost of products sold for the six months ended October 24, 2025 was $637 million as compared to $577 million for the six months ended October 25, 2024. The increase in cost of products sold was driven by the increased volume of products sold as well as changes in product mix as further described below.

The decrease in cost of products sold as a percentage of net sales for the six months ended October 24, 2025 was primarily due to favorable currency impact on net sales in addition to changes in the Italian payback accruals impacting net sales for the six months ended October 24, 2025 and October 25, 2024. The decrease was partially

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offset by 140 bps increase from product mix as a result of higher mix of CGMs, which have a lower gross profit margin relative to our insulin pumps and other consumables.

Research and development expense

Research and development costs include costs of research, engineering, and technical activities to develop a new product or service or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses.

Research and development expense for the six months ended October 24, 2025 was $236 million as compared to $217 million for the six months ended October 25, 2024. The increase was primarily driven by a $7 million increase in personnel expenses to support product development efforts and $10 million of an acquisition of technology not yet approved by regulators.

Selling, general, and administrative expenses

Selling, general, and administrative expense primarily consists of salaries and wages, benefits, other administrative costs, such as professional fees and marketing expenses, stock-based compensation, and restructuring associated expenses. Selling, general, and administrative expense also includes amortization expense related to our customer list and tradename intangible assets.

Selling, general, and administrative expenses for the six months ended October 24, 2025 were $575 million as compared to $536 million for the six months ended October 25, 2024. The increase was primarily driven by $25 million for incremental commercialization activities to support higher sales of the Company, particularly Simplera Sync outside the United States, and increased marketing expenses in the U.S, and $7 million increase for short-term and long-term incentives.

Certain litigation charges

We classify specified certain litigation charges as certain litigation charges in the combined statements of loss. During the six months ended October 24, 2025, the Company recognized $17 million of certain litigation charges in connection with the Diabetes Pump Retainer Ring litigation. Refer to Note 13 “Commitments and Contingencies,” to the unaudited condensed combined financial statements included elsewhere in this prospectus for further information.

Other operating expense (income), net

Other operating expense (income), net primarily includes restructuring expense, currency remeasurement, and income from research and development funding arrangements.

Other operating expense (income), net was $7 million of expense for the six months ended October 24, 2025 as compared to $5 million of income for the six months ended October 25, 2024. The change was primarily driven by $19 million of reduced proceeds from funded research and development arrangements due to the timing of certain new product development spend.

Other non-operating expense, net

Other non-operating expense, net includes investment gains and losses. Other non-operating expense, net was insignificant for both the six months ended October 24, 2025 and October 25, 2024.

Income tax provision

Income tax provision includes current and deferred income tax expense related to federal, state, and international jurisdictions.

The income tax provision was $23 million for the six months ended October 24, 2025 as compared to $3 million for the six months ended October 25, 2024. The change in the effective tax rate and income tax provision primarily

120

relates to year-over-year changes in operational results by jurisdiction and the impact of valuation allowances in certain jurisdictions.

On July 4, 2025, the U.S. government enacted The One Big Beautiful Bill Act of 2025 which includes, among other provisions, changes to the U.S. corporate income tax system including the allowance of immediate expensing of qualifying research and development expenses and permanent extensions of certain provisions within the Tax Cuts and Jobs Act. Certain provisions are effective for the Company beginning fiscal year 2026. The impact of these provisions for the six months ended October 24, 2025 was not significant, and the impacts of these provisions to fiscal year 2026 and beyond are not expected to be material.

Comparison of the Fiscal Years Ended April 25, 2025, April 26, 2024, and April 28, 2023

The following table sets forth a summary of our combined results of operations for the years indicated, and the changes between periods.

Change

Fiscal Year

2025 to 2024

2024 to 2023

(Dollars in millions)

2025

2024

2023

Amount

Percent

Amount

Percent

Net sales

2,715

MiniMed Group, Inc. S-1/A