FULLTEXT DEL 1 AV 2
10-K – 2026-02-18 – podd-20251231.htm
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Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31 , 2025
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number 001-33462
INSULET CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware 04-3523891
(State or Other Jurisdiction of
Incorporation or Organization) (I.R.S. Employer
Identification No.)
100 Nagog Park Acton Massachusetts 01720
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s telephone number, including area code: ( 978 ) 600-7000
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common Stock, $0.001 Par Value Per Share PODD The NASDAQ Stock Market, LLC
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting 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 x Non-accelerated filer ¨
Accelerated filer ¨ Smaller reporting company ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ¨
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ¨
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The aggregate market value of the common stock held by non-affiliates of the registrant computed by reference to the last reported sale price of the Common Stock as reported on The NASDAQ Global Market on June 30, 2025 was approximately $ 22.1 billion.
The number of shares of common stock outstanding as of February 11, 2026 was 70,395,848 .
DOCUMENTS INCORPORATED BY REFERENCE
The registrant intends to file a proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2025. Portions of such proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
TABLE OF CONTENTS
PART I
Item 1 Business
3
Item 1A Risk Factors
14
Item 1B Unresolved Staff Comments
25
Item 1C
Cybersecurity
25
Item 2 Properties
27
Item 3 Legal Proceedings
27
Item 4 Mine Safety Disclosures
27
PART II
Item 5 Market for Registrant ’ s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
28
Item 6 Reserved
29
Item 7 Management ’ s Discussion and Analysis of Financial Condition and Results of Operations
30
Item 7A Quantitative and Qualitative Disclosures About Market Risk
38
Item 8 Financial Statements and Supplementary Data
39
Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
73
Item 9A Controls and Procedures
73
Item 9B Other Information
73
PART II I
Item 10 Directors, Executive Officers and Corporate Governance
74
Item 11 Executive Compensation
74
Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
74
Item 13 Certain Relationships and Related Transactions, and Director Independence
74
Item 14 Principal Accounting Fees and Services
74
PART I V
Item 15 Exhibits, Financial Statement Schedules
75
Item 16 Form 10-K Summary
79
SIGNATURES
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PART I
Item 1. Business
Overview
Insulet Corporation (“we” or the “Company”) is primarily engaged in the development, manufacture, and sale of its proprietary continuous insulin delivery systems for people with insulin-dependent diabetes. The Omnipod platform includes: the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), and the Omnipod Insulin Management System (“Classic Omnipod”).
We also produce pods for Amgen for use in the Neulasta ® Onpro ® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.
Market Opportunity: Management of Diabetes
Diabetes is a chronic, life-threatening disease for which there is no known cure. It is caused by the body’s inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately regulating blood glucose levels. Glucose, the primary source of energy for cells, must be maintained at certain concentrations in the blood in order to permit optimal cell function and health. In people with diabetes, blood glucose levels fluctuate between very high levels, a condition known as hyperglycemia, and very low levels, a condition called hypoglycemia. Hyperglycemia can lead to serious short-term complications, such as confusion, vomiting, dehydration, and loss of consciousness and long-term complications, such as blindness, kidney disease, nervous system disease, occlusive vascular diseases, stroke, cardiovascular disease, or death. Hypoglycemia can lead to confusion, loss of consciousness, or death.
Diabetes is typically classified as either type 1 or type 2:
• Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin. It is diagnosed throughout the age spectrum, with over half of newly diagnosed cases occurring in adulthood. Individuals with type 1 diabetes require daily insulin therapy to survive. We estimate that approximately 6 million people have type 1 diabetes in the countries we currently serve.
• Type 2 diabetes, the more common form, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin. Historically, type 2 diabetes has occurred in later adulthood, but its incidence is increasing among children and young adults, due primarily to increasing obesity. Initially, many people with type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise, and/or medications, both oral and injectable, including SGLT2 inhibitors and GLP-1 drugs. As their diabetes advances, some individuals progress to multiple drug therapies, which often include insulin therapy. People with type 2 diabetes who take insulin either require intensive insulin therapy (typically multiple injections of insulin per day) or basal (long-acting) insulin (typically a single injection daily or weekly). We estimate that approximately 6 million people have insulin-requiring type 2 diabetes in the countries we currently serve and another 3 million people with type 2 diabetes in the United States require only basal insulin.
We estimate that approximately 40% of the type 1 diabetes population in the United States and 25% of the international type 1 diabetes population use insulin pump therapy. An even smaller portion of the U.S. and international insulin-requiring type 2 diabetes population and the U.S. basal only insulin type 2 population use insulin pump therapy. We believe these factors present a significant available market for our Omnipod platform globally.
Throughout this Annual Report on Form 10-K, we refer to both type 1 diabetes and insulin-requiring type 2 diabetes as insulin-dependent diabetes.
Diabetes Management Challenges
Diabetes is often frustrating and difficult for people to manage. Blood glucose levels can be affected by the carbohydrate and fat content of meals, exercise, stress, illness, impending illness, hormonal releases, variability in insulin absorption, and changes in the effects of insulin on the body. For people with insulin-dependent diabetes, many corrections, consisting of the administration of additional insulin or ingestion of additional carbohydrates, are needed throughout the day in order to maintain blood glucose levels within normal ranges. Achieving this result can be very difficult with multiple daily injections of insulin. Individuals with diabetes attempting to control their blood glucose levels tightly to prevent the long-term complications associated with fluctuations in blood glucose levels are at greater risk for overcorrection and hypoglycemia. Additionally, the time spent managing fluctuations in blood glucose levels and the fear associated with hypoglycemia can be incredibly stressful for individuals with diabetes and their families.
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Current Insulin Therapy
People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, for background metabolic needs. In addition to basal insulin, people with insulin-dependent diabetes may require supplemental insulin, known as bolus insulin, to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by other physiological reasons. There are two primary types of insulin therapy practiced today: multiple daily injection (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.
MDI therapy involves injecting fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range. MDI therapy also requires a separate injection of a long-acting (basal) insulin, to control glucose levels between meals. By comparison, insulin pump therapy uses only fast-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements. Insulin pump therapy allows individuals to customize their bolus and basal insulin doses to meet their insulin needs throughout the day and is intended to more closely resemble the physiologic function of a healthy pancreas.
Insulin pumps perform continuous subcutaneous insulin infusion and typically use a programmable device and an infusion set to administer insulin into the body. Insulin pump therapy has been shown to provide numerous advantages relative to MDI therapy. For example, insulin pump therapy virtually eliminates individual insulin injections, delivers insulin more accurately and precisely than injections, often improves HbA1c (a common measure of average blood glucose levels over time) over time, provides greater flexibility with meals, exercise, and daily schedules, and can reduce severe low blood glucose levels. We believe that these advantages, along with technological advancements, including the use of continuous glucose monitoring technology and automated insulin delivery (“AID”) algorithms, and increased awareness of insulin pump therapy, will continue to generate demand for insulin pump devices.
Our Solution: The Omnipod Platform
The Omnipod platform offers continuous insulin delivery that provides all the benefits of insulin pump therapy in a unique way without the need for external tubing required with conventional pumps. The small, lightweight, self-adhesive disposable tubeless Omnipod device (“Pod”), can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh, or lower back. We have designed Omnipod products to fit within the normal daily routines of users. The Pod can be worn for up to three days at a time and, because it is waterproof (with an IP28 rating for up to 25 feet for 60 minutes), there is no need to remove it when showering, swimming, or performing other activities. Omnipod products provide for virtually pain-free automated cannula (a small flexible tube) insertion through which insulin is delivered, eliminating the need for MDI or the use of pump and tubing. We refer to the delivery of insulin with the Pod as “Pod therapy.” We believe the Omnipod platform’s innovative proprietary design and differentiated features allow people with insulin-dependent diabetes to live their lives and manage their diabetes with unprecedented freedom, comfort, convenience, and ease.
Omnipod 5 Omnipod DASH
Omnipod 5
In 2022, we received U.S. Food and Drug Administration (“FDA”) clearance and CE Mark approval under the European Union Medical Device Regulation (“MDR”) for Omnipod 5, which builds on our Omnipod DASH platform. Omnipod 5 is currently available in 19 countries. Additionally, in August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes (ages 18 years and older) in the United States.
Omnipod 5 includes a proprietary AID algorithm embedded in the Pod. The Pod integrates with a third-party continuous glucose monitor (“CGM”) to obtain glucose values through secure wireless Bluetooth communication. The embedded algorithm utilizes these glucose values to predict glucose levels into the future and automatically adjusts insulin dosing intended
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to improve time-in-range (a dynamic measure of the percentage of time spent in glucose range) and reduce the occurrence of blood glucose highs and lows. The user can also deliver additional insulin doses for snacks or meals or to correct high blood glucose through the system. The Pod can be controlled by an Insulet-provided handheld device or, in the U.S., a user-downloaded Android app or iOS app, with full smartphone compatibility. The Omnipod 5 Controller and the Android and iOS apps use cloud-based technology to upload data wirelessly via a built-in SIM card or secure Wi-Fi. The Pod currently integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets.
Omnipod DASH
Omnipod DASH features a secure wireless Bluetooth enabled Pod that is controlled by a smartphone-like Personal Diabetes Manager (“PDM”) with a color touch screen user interface. In the U.S., the PDM has Wi-Fi capabilities to enable automatic data uploads providing users and their clinicians with cloud access to data and enhancements for pushing software updates wirelessly to users. Omnipod DASH provides continuous insulin delivery at preset rates, eliminating the need for individual insulin injections. In addition, insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine. Omnipod DASH delivers insulin in two ways:
• A small, constant background supply of insulin is delivered automatically at a programmed rate, all day and night.
• An extra dose of insulin can be delivered when needed to match the carbohydrates in a snack or meal to correct high blood glucose.
Omnipod Classic
Following the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product. Accordingly, we are phasing out our Classic Omnipod product.
Data Management
We have partnered with Glooko Inc. (“Glooko”) to connect user data with Glooko’s comprehensive diabetes data management system (including Diasend in selected regions). Glooko provides a cloud-based application for clinicians and users accessible through a kiosk, home computer, or a mobile application on the user’s smartphone that provides users and their healthcare providers access to insulin delivery trends, blood glucose levels, and other integrated data.
In 2026, we launched Omnipod Discover, a data analytics and reporting platform designed to give users, their caregivers, and health care providers actionable insights. Omnipod Discover helps to identify trends and is intended to provide supplemental data to support diabetes management for Omnipod 5 users and to aid healthcare providers in patient care. It also streamlines the process of starting on Omnipod products.
Security
Paramount to our ability to deliver full compatible smartphone control is our commitment to cybersecurity and information security. With certifications from the International Organization for Standardization (“ISO”) and the Diabetes Technology Society’s cybersecurity and assurance program, Insulet is globally recognized for incorporating the highest standards for cybersecurity, information security, and safety, including secure data transfer between the Pod and PDM or cell phone application, as applicable, as well as secure cloud storage. See Item 1C. “Cybersecurity” for additional information.
Third-Party Coverage and Reimbursement
In the United States, we sell our products primarily through wholesalers and, to a lesser extent to healthcare organizations, pharmacies, and consumers. Consumers generally have coverage that pays for Omnipod products through commercial insurance plans or federal and state government healthcare programs, including Medicare and Medicaid. We enter contracts establishing reimbursement for Omnipod products with national and third-party payors and government agencies that provide reimbursement in all 50 states. Medicare Part D Plan Sponsors may provide coverage for Omnipod products under the Medicare Part D prescription drug program, which requires negotiating with third-party payors in order to provide our product through the pharmacy channel. Our Omnipod platform’s unique patented design allows us to provide Pod therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the United States.
In our international locations, we sell either directly to consumers or through a distributor/intermediary. In all countries where we operate, either Insulet or our partners establish appropriate reimbursement contracts with local healthcare systems. Reimbursement structures vary by country and our unique offering allows us to provide Pod therapy in attractive pricing structures that reduce the risk to payors while expanding access to consumers.
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Markets and Distribution Methods
Omnipod products are currently available in the following 25 countries:
Australia*
Cyprus Greece Netherlands*
Switzerland*
Austria Denmark*
Iceland Norway*
Turkey
Belgium*
Finland*
Israel*
Qatar*
United Arab Emirates*
Canada*
France*
Italy*
Saudi Arabia*
United Kingdom*
Croatia Germany*
Kuwait*
Sweden*
United States*
* Represents country in which Omnipod 5 is available
We sell Omnipod products to wholesalers that supply the pharmacy channel in the United States. In addition, we sell Omnipod products through distribution partners and directly to consumers. For the year ended December 31, 2025, 86% of Omnipod product sales globally were through intermediaries.
The percentages of total revenue for customers that represent 10% or more of total revenue was as follows:
Years Ended December 31,
2025 2024 2023
Distributor A 27% 28% 28%
Distributor B 26% 26% 24%
Distributor C 25% 21% 19%
Our sales and marketing efforts are focused on customer acquisition and retention to meet user, clinician, and payor demands for our Omnipod products. We have a comprehensive sales and marketing approach, which communicates the benefits of the Omnipod platform to users, physicians, and providers. This includes three areas of focus:
• Building consumer awareness about the features and benefits that Omnipod products provide to simplify diabetes management.
• Strengthening physician support by demonstrating clinical evidence of how Omnipod products improve outcomes and quality of life and providing data and insights to physicians offering diabetes care.
• Providing payors with the clinical and economic justifications for why Omnipod products offer unique value to the people they insure.
Training
We believe that training consumers on how to use Omnipod products is an important factor to promote successful outcomes and customer retention. We have streamlined and standardized our training to support customer success and cost-effective onboarding by developing online resources and have increased our field clinician team to directly train new users. We created tailored online training programs for Omnipod customers transitioning to Omnipod 5 and new Omnipod customers transitioning from MDI. Our distributors have also implemented virtual training programs.
Customer Support
We seek to provide our customers with high quality customer support, from product ordering to insurance investigation, order fulfillment, and ongoing support. Our customer support systems are integrated with our sales, reimbursement, and billing processes, allowing us to provide customers with reliable support by telephone and through our website.
Competition
The diabetes medical device market is highly competitive, subject to rapid change, and significantly affected by new product introductions. Our Omnipod platform competes for consumers in the insulin delivery market. Because most new Omnipod users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we primarily compete with companies that provide products and supplies for MDI therapy, including smart pens. We also compete with companies in the insulin pump market, which today consists of tubed pump companies, in addition to companies that are working to develop and market new insulin “patch” pumps and other methods for the treatment of insulin-dependent diabetes. We are also aware of the increasing use of GLP-1 products that may delay the progression of type 2 diabetes in obese patients.
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Research and Development
Our innovation programs are designed to drive:
• simplicity of user interaction with our systems to minimize the burden of diabetes;
• improved outcomes, primarily through algorithm advancements;
• insights and value from our growing datasets and analytics; and
• user choice of sensor and smartphone integrations.
Many of our research and development efforts are focused on making improvements to Omnipod 5, including adding features and functionality that will deliver increased economic value and convenience to users. Advances in innovation in 2025 include the following:
• launched Omnipod 5 with Dexcom’s G7 CGM sensor in our iOS app in the United States;
• launched Omnipod 5 integration with Dexcom’s G7 CGM sensor in Germany, Sweden, Denmark, Finland and Italy;
• launched Omnipod 5 integration with Abbott’s FreeStyle Libre 2 Plus sensor in Australia; and
• received 510(k) clearance for enhancements to the Omnipod 5 algorithm to include a lower target glucose set point.
We also continue to advance work to improve the Omnipod 5 algorithm and simplify the data and insights provided to customers. In addition, we are working to integrate Omnipod 5 with Libre 3 Plus and developing Omnipod 6, our next-generation AID product. In 2025, we completed STRIVE, our pivotal study for the next generation hybrid closed loop system. Further, we continue to develop a fully closed loop AID system for type 2 diabetes (“FCL (T2)”). In 2025, we completed enrollment for EVOLUTION 2, our safety and feasibility study for FCL (T2) and we plan to start the U.S. investigational device exemption (“IDE”) pivotal study in 2026.
Manufacturing and Quality Assurance
We produce our products at our two highly automated manufacturing facilities in Acton, Massachusetts and Johor, Malaysia. Additionally, we are investing in a third manufacturing plant in Costa Rica to support our continued growth. We also produce our devices on manufacturing lines at a facility in China operated by a contract manufacturer.
Raw Materials, Components, and Sub-Assemblies
We use a broad range of raw materials in the assembly and manufacturing of our products. We purchase our raw materials and select components and sub-assemblies used in the manufacturing of our products from external suppliers. Where feasible, we purchase raw material, components and sub-assemblies from manufacturers with whom we are at least dual-sourced. However, we purchase some components from a single or limited number of sources for reasons of proprietary know-how, quality assurance, cost-effectiveness, or constraints resulting from regulatory requirements. We rely on a limited number of suppliers for a certain number of the components and sub-assemblies used in the manufacture of our products, including application-specific integrated circuit chips, Bluetooth low-energy chips, and other specialized parts. Further, the design of certain components and sub-assemblies (including, in some instances, the raw materials used to manufacture them) that we purchase is proprietary and the intellectual property rights may be owned exclusively by one party. In such cases, we are sole-sourced, with the supplier controlling the intellectual property rights. These sole-sourced components, sub-assemblies and raw materials are critical to the design and functionality of our products. In the case of sole-sourced parts, we manage risk by holding inventory in-house and at the supplier to lower the risk of a supply disruption. We work closely with all suppliers to preserve continuity of supply while maintaining high quality and reliability.
Quality Assurance
We utilize outside vendors for the supply of components, sub-assemblies, raw materials, and various services used in the manufacture of our products. Our outside vendors produce the components to our specifications, and they are audited periodically by our Quality team to confirm conformity with the specifications, policies, and procedures for our products. Our Quality team also inspects and tests our products at various steps in the manufacturing cycle to facilitate compliance with our specifications. We have received our ISO, European Union MDR, and Medical Device Single Audit Program certifications for our Quality Management System from BSI Group, an accredited Notified Body for CE Marking. Processes utilized in the manufacture, test, and release of our products have been verified and validated as required by the FDA and other regulatory bodies. As a medical device manufacturer and distributor, our manufacturing facilities and the facilities of our suppliers are subject to periodic inspection by the FDA, certain corresponding state agencies, and other regulatory bodies.
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Intellectual Property
To maintain a competitive advantage, we believe we must develop and preserve the proprietary aspect of our technologies. We rely on a combination of copyright, patent, trademark, trade secret, and other intellectual property laws, non-disclosure agreements, and other measures to protect our proprietary rights. We require our employees, consultants, and advisers to execute non-disclosure agreements in connection with their employment, consulting, or advisory relationships with us, where appropriate. We also require employees, consultants, and advisers who work on our products to agree to disclose and assign to us all inventions conceived during their work with us that are developed using our property or relate to our business.
Patents
As of December 31, 2025, we had over 1,000 patents in the United States and certain other countries, with expiration dates ranging from 2026 through 2047 and had over 700 patent applications pending. The issued patents and pending patent applications cover, among other things:
• the Omnipod drive system;
• the Omnipod cannula insertion system;
• software, such as algorithms, apps and user interfaces, for controlling our current and next generation Omnipod products; and
• various novel aspects of our current and potential future generations of Omnipod products, and other mechanisms for the delivery of pharmaceuticals.
Trademarks
We have registered various trademarks associated with our business with the United States Patent and Trademark Office on the Principal Register and in other appropriate jurisdictions. Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , OmnipodPromise ® , Omnipod Discover TM, SmartAdjust TM , PodPals ® , Podder ® , and PodderCentral ® .
Government Regulation
United States FDA Regulation
Our products are medical devices that are subject to extensive and ongoing regulation by the FDA and other federal, state, and local regulatory bodies. FDA regulations govern, among other things, product design and development, preclinical and clinical testing, pre-market clearance or approval, manufacturing, labeling, product storage, advertising and promotion, sales and distribution, post-market adverse event reporting, post-market surveillance, complaint handling, repair or recall of products, and record keeping.
Unless an exemption applies, each medical device we seek to commercially distribute in the United States will require either prior 510(k) clearance or pre-market approval (“PMA”) from the FDA. A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent. Both the 510(k) clearance and PMA processes can be expensive and lengthy and entail significant user fees. We have obtained 510(k) clearance for Classic Omnipod, Omnipod DASH, and Omnipod 5. In addition, we may be required to obtain a new 510(k) clearance or pre-market approval for significant post-market modifications to our products.
Clinical Trials. Clinical trials are almost always required to support a PMA application and may also be required to support 510(k) submissions. If the device presents a “significant risk” to human health as defined by the FDA, the FDA requires the device sponsor to submit and obtain Investigational Device Exemption ("IDE") approval prior to commencing human clinical trials. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and privacy. A clinical trial may be suspended by the FDA or at a specific site by the relevant Institutional Review Board at any time for various reasons, including a belief that the risks to the trial participants outweigh the benefits of participation in the clinical trial. Even if a clinical trial is completed, its results may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise insufficient for us to obtain approval of our product.
Ongoing Regulation. After a device is placed on the market, numerous regulatory requirements apply, including:
• establishment registration and device listing;
• the FDA’s Quality System Regulation (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during the development and manufacturing process;
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• labeling regulations and prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses, and other requirements related to promotional activities;
• medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;
• corrections and product recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce the risk to health posed by the device or to remedy a violation of the federal Food, Drug, and Cosmetic Act that may present a risk to health. In addition, the FDA may order a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; and
• post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and efficacy data for the device.
Failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies, which may include any of the following sanctions: untitled letters or warning letters, fines, injunctions, consent decrees, civil or criminal penalties, recall or seizure of our current or future products, operating restrictions, partial suspension or total shutdown of production, refusal of or delay in granting 510(k) clearance or PMA of new products or modified products, rescinding previously granted 510(k) clearances or withdrawing previously granted PMAs, or refusal to grant import or export approval of our products.
We are subject to and have experienced announced and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of our subcontractors. If, as a result of these inspections, the FDA determines that our equipment, facilities, laboratories, or processes do not comply with applicable FDA regulations and conditions of product approval, the FDA may seek civil, criminal, or administrative sanctions and/or remedies against us, including the suspension of our manufacturing operations.
Other Regulations
Licensure. In order to sell our product through the pharmacy channel in the United States, we are required to work with intermediaries who have the appropriate pharmacy license for the applicable market. We are also subject to certain state laws regarding the professional licensure of our diabetes educators. We believe that our certified diabetes educators are in compliance with all such state laws. However, if our educators or we were to be found non-compliant, we may need to modify our approach to providing education, clinical support, and customer service.
Federal Anti-Kickback and Self-Referral Laws. The federal healthcare Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of any form of remuneration, directly or indirectly, in return for, or to induce:
• the referral of an individual to any person or entity for the furnishing or arranging for the furnishing of items or services that are reimbursable under Medicare, Medicaid, or any other federal healthcare program; or
• the purchase, lease, order of, or recommendation of the purchase, lease, or order of any item or service that is reimbursable under Medicare, Medicaid, or any other federal healthcare program.
The federal Anti-Kickback Statute has been interpreted to apply to arrangements between drug and medical device manufacturers and suppliers on one hand and prescribers, patients, purchasers, and formulary managers on the other. In addition, claims resulting from a violation of the federal Anti-Kickback Statute constitute false or fraudulent claims for purposes of the federal civil False Claims Act discussed below. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common business practices from prosecution and administrative sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be perceived as inducing the prescription, purchase, or recommendation of Omnipod products may be subject to scrutiny under the law. For example, we may provide the initial training to users necessary for appropriate use of our product either through our own diabetes educators or by contracting with outside diabetes educators that have completed a Certified Pod Trainer course. We compensate outside diabetes educators for their services at contracted rates deemed to be consistent with the market. We have structured our arrangements with diabetes educators and other business practices to comply with statutory exemptions and regulatory safe harbors whenever possible, but our practices may be subject to scrutiny if they fail to strictly comply with the criteria in the exemption or regulatory safe harbor. Moreover, there are no safe harbors for many common practices such as providing reimbursement assistance, coding and billing information, or other customer assistance and product support programs. If any of our practices, arrangements, or programs are found to violate the federal Anti-Kickback Statute, we could be subject to significant criminal, civil, and administrative penalties, including imprisonment, fines, damages, and exclusion from Medicare, Medicaid, or other governmental programs.
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Federal law also includes a provision commonly known as the “Stark Law,” which prohibits a physician from referring Medicare or Medicaid patients to an entity for the furnishing of certain “designated health services,” in which the physician has an ownership or investment interest or with which the physician has entered into a compensation arrangement. Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received for items and services referred by a physician with a noncompliant arrangement, civil damages and penalties, and exclusion from Medicare, Medicaid, or other governmental programs.
Federal Civil False Claims Act. The federal civil False Claims Act imposes penalties against any person or entity who, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment of government funds, or knowingly makes, uses, or causes to be made or used a false record or statement material to a false or fraudulent claim. Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the False Claims Act are subject to the imposition of significant per claim penalties, which include three times the amount of damages that the federal government sustained, and possible exclusion from participation in federal healthcare programs like Medicare and Medicaid. We believe that we are in compliance with the federal government’s laws and regulations concerning the filing of claims for reimbursement. However, many drug and medical device manufacturers have been investigated or subject to lawsuits by whistleblowers and have reached substantial financial settlements with the federal government under the False Claims Act for a variety of alleged improper marketing activities, including providing free product to customers with the expectation that the customers would bill federal programs for the product or causing submission of false claims by providing inaccurate coding or billing information to actual or prospective purchasers. We also may be subject to other federal false claim laws, including federal criminal statutes that prohibit making a false statement to the federal government.
Civil Monetary Penalties Law. We are subject to the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services. Noncompliance can result in significant civil monetary penalties for each wrongful act, an assessment of three times the amount claimed for each item or service, and exclusion from the federal healthcare programs.
Federal Healthcare Fraud Statutes. We are also subject to federal healthcare fraud statutes that, among other things, impose criminal and civil liability for executing a scheme to defraud any healthcare benefit program, including non-governmental programs, and prohibit knowingly and willfully falsifying, concealing, or covering up a material fact, making any materially false or fraudulent statement or representation, or making or using any false writing or document with knowledge that it contains a materially false or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items, or services. Violations of these statutes can result in significant civil, criminal, and administrative penalties, fines, damages, and exclusion from federal healthcare programs.
State Fraud and Abuse Laws and Marketing Restrictions. Many states have adopted anti-kickback, anti-referral laws, and false claims laws and regulations analogous to the federal civil Anti-Kickback Statute and federal False Claims Act. In some cases, these state laws apply regardless of the payor, including private payors. Moreover, several states have imposed requirements to disclose payments to healthcare providers, restrictions on marketing and other expenditures, and requirements to adopt a code of conduct or compliance program with specific elements. While we believe we are in compliance with such laws, any failure could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.
Administrative Simplification of the Health Insurance Portability and Accountability Act of 1996. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) mandated the adoption of standards for the exchange of electronic health information to encourage overall administrative simplification and enhance the effectiveness and efficiency of the healthcare industry. Ensuring privacy and security of patient information is one of the key factors driving the legislation. HIPAA regulations have been amended under the Health Information Technology for Economic and Clinical Health Act of 2009. If we are found to be in violation of HIPAA, we could be subject to civil or criminal penalties.
U.S. Privacy Laws. Many states have enacted various privacy laws of general applicability over the past several years. For example, the California Consumer Privacy Act (“CCPA”) and California Privacy Rights Act (“CPRA”) are consumer privacy laws that provide certain privacy rights and consumer protection for residents of the state of California. These consumer rights include the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request a company to the delete personal information collected, the right to opt-out of the sale of personal information, and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right. If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance. In addition, general privacy legislation has been filed in Congress in previous sessions, but the final form of the legislation and when it might be enacted is difficult to predict.
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General Data Protection Regulation. In the European Economic Area, the General Data Protection Regulation (“GDPR”) is a comprehensive data protection regime that imposes requirements relating to, among other things, consent to process personal data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches, and use of third-party processors. If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties for noncompliance. The European Union has laid out a multi-year plan for additional privacy and data regulation, building upon the GDPR, and has begun to execute on that plan.
Patient Protection and Affordable Care Act . The Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010 (“ACA”) enacted significant changes to the provision of and payment for healthcare in the United States. Under the ACA and related laws and regulations, federal and state government initiatives are focused on limiting the growth of healthcare costs and implementing changes to healthcare delivery structures. These reforms are intended in part to put increased emphasis on the delivery to patients of more cost-effective therapies and could adversely affect our business. We expect that the ACA will continue to have a significant impact on the delivery of healthcare in the United States and on our business in the near term.
Physician Payments Sunshine Act . The Physician Payments Sunshine Act, implemented as the Open Payments program, requires manufacturers of drugs and devices for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to direct or indirect payments and other transfers of value provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives. Failure to disclose reportable payments could subject us to significant penalties. Certain states’ laws require additional reporting of payments and transfers of value to healthcare providers.
Since these laws and regulations continue to evolve, we lack definitive guidance on their application as they relate to certain of our arrangements and programs, including our program for user training offered to providers. We cannot predict the final form of these regulations or the effect their application will have on us.
Ensuring that our business arrangements and interactions with healthcare professionals, third‑party payors, customers, and others comply with applicable healthcare laws and regulations requires substantial resources. Because of the breadth of these laws and the narrowness of the exceptions or safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of these laws.
U.S. Foreign Corrupt Practices Act ( “ FCPA ” ). We are subject to the FCPA in the United States. and to similar anti-bribery laws in other jurisdictions, which generally prohibit companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining or retaining business. Because of the predominance of government-sponsored healthcare systems around the world, our customer relationships outside of the United States may be with governmental entities and therefore subject to such anti-bribery laws. We operate in parts of the world that have experienced governmental corruption to some degree, and in certain circumstances strict compliance with anti-bribery laws may conflict with local customs and practices. Our policies mandate compliance with these anti-bribery laws. Despite our training and compliance programs, our internal control policies and procedures may not protect us from reckless or criminal acts committed by our employees or agents.
Outside the United States, we are subject to the U.K. Bribery Act and similar anti-bribery laws in other jurisdictions in which we operate. Such laws generally prohibit U.S.-based companies and their intermediaries from making improper payments to foreign officials, or in the case of the U.K. Bribery Act to any person, for the purpose of obtaining or retaining business. In addition, the European Union Whistleblower Directive and other applicable laws around the world impose specific requirements on companies regarding speak up policies and non-retaliation policies.
Artificial Intelligence ( “ AI ” ). Governments around the world have begun to regulate AI, including generative AI. The Cybersecurity Directive and the Artificial Intelligence Act (“EU AI Act”) was enacted in August 2024, with provisions taking effect through August 2026. Guidance from EU regulators is starting to be published and we will continue to track developments in this area and adjust operations accordingly. In the United States, California, Colorado, and Texas have introduced AI laws although they are not effective yet. Other countries have also regulated the use of AI. AI systems are currently deployed in our business operations and any additional AI systems to the extent developed or deployed in our business operations or in our products, we will be subject to AI regulations governing AI systems. We are engaged in regular reviews of development and licensing of software used in the business for compliance with relevant AI regulations.
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Working, Environmental and Manufacturing Practices . In addition, we are subject to numerous federal, state, foreign, and local laws relating to safe working conditions, manufacturing practices, and environmental protection. We may be required to incur significant costs to comply with these laws and regulations in the future.
Environmental Reporting . Increasingly, regulators, customers, investors, employees, and other stakeholders are focusing on environmental, social, and governance matters and related disclosures. The collection, measurement, and reporting of environmental data is subject to evolving reporting standards, including California’s climate disclosure requirements, and similar regulations established by other international regulatory bodies, such as the Corporate Sustainability Reporting Directive in the European Union. In addition, a number of our customers who are payors or distributors have adopted, or may adopt, procurement policies that include environmental provisions that their suppliers or manufacturers must comply with. If we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry, or stakeholder expectations regarding environmental issues, investors may reconsider their investment in us, and customers and suppliers may choose to limit their business with us.
International Medical Device Regulations
International sales of medical devices are subject to foreign government regulations, which may vary substantially from country to country. The time required to obtain regulatory approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. There is a trend towards harmonization of quality system standards among the European Union, United States, Canada, and various other industrialized countries.
The primary regulatory body in Europe is that of the European Union, which includes most of the major countries in Europe. Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices. The European Union has adopted numerous directives and standards regulating the design of medical devices, as well as conducting clinical trials, manufacturing, labeling, and adverse event reporting for medical devices, including the Medical Device Directive (“MDD”) and the MDR, which replaced MDD in 2021. Certain devices that comply with the requirements of the MDD can be commercially distributed until December 2027 if certain requirements are met. The method of assessing conformity with the applicable directive varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body”. The latter is required in order for a manufacturer to commercially distribute the product throughout the European Union. This third-party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s product. To market our products outside of the European Union, we are required to seek regulatory approval on a country-by-country basis.
We have obtained the right to affix the CE Mark under MDR, and UK Conformity Assessed (UKCA marking) to Omnipod 5 and Omnipod DASH, which allows us to distribute these products throughout the European Union and in the United Kingdom. We have obtained the right to affix the CE Mark to Classic Omnipod under the MDD and can continue to sell Classic Omnipod through 2027 in the European Union and in other countries that recognize the CE Mark. We have also secured the necessary regulatory approvals for all other markets in which we currently distribute Omnipod products.
Human Capital Resources
Employees
Our people are our most valuable asset and are the source of our innovation and our success. We strive to attract and retain the best talent with competitive compensation and benefits, opportunities for growth and development, and a culture that emphasizes fair and equitable treatment. As of December 31, 2025, we had approximately 5,400 full-time employees, representing a 38% increase over the prior year. Approximately 60% of our employees are located in the United States and the remainder are located in 17 other countries.
Our culture is driven by our ways of working, which define the key behaviors that we believe are most important to our success and to creating an exceptional employee experience. Additionally, we promote our Insulet for Good program, which enables employees globally to engage in volunteerism and corporate philanthropy in ways aligned with our corporate strategic priorities. In 2025, we added an employee gift matching element to Insulet for Good where Insulet contributes to causes our employees care about. Employee donations to non-profit organizations are matched, and volunteer hours have an Insulet financial support mechanism to engage and amplify employee contributions.
To assess employee retention and engagement and identify potential opportunities for improvement, we conduct periodic ‘Your Voice’ employee pulse surveys and take timely action to address key areas of employee concern. Our executive leadership team also conducts regular Town Hall meetings to ensure our global employees are highly engaged and receive timely business updates. To help our remote employees feel socially connected to their colleagues, we created our “Stay Connected” initiative, which includes virtual meetings with our executive team members. These virtual meetings are designed as casual conversations with our executives so employees can talk about what is on their minds, get to know the executive leaders, and connect with colleagues from across the organization.
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Our success thrives on the various perspectives, thoughts, experiences, and backgrounds within our workforce. We are committed to creating a global culture that reflects the diversity of the customers we serve and creates an environment where all employees feel welcomed, respected, and valued. Accordingly, we are committed to providing equal opportunity in all aspects of our Company culture and workplace.
Training and Development
We are committed to fostering an environment in which our employees continuously learn and develop the skills and capabilities needed for their success by offering both leadership and professional skills development programs. All employees who join Insulet undergo a robust onboarding program that educates them about diabetes, our products, business strategy, culture, ways of working, and mission. This onboarding is followed by our career development program, through which each employee creates an Individual Development Plan that is regularly reviewed and updated with their manager. We also offer LinkedIn Learning and tuition reimbursement to eligible employees. Further, managers participate in our leadership development program to support the growth, capabilities, and development of our future leaders. In addition, we offer intensive Customer Care and Sales New Hire Training.
Competitive Pay and Benefits
Our compensation program is designed to align employee pay with our performance and to provide the proper incentives to attract, retain, and motivate employees to achieve superior results. The structure of our compensation program balances incentive compensation for both short-term and long-term performance.
We are committed to providing comprehensive benefit options that allow our employees and their families to live healthier and more secure lives. Our benefits vary by country with a wide range of offerings including health and life insurance, paid time off, employee stock purchase plan, paid parental leave, business travel accident insurance, and employee assistance program. In addition, we offer Pod Perks, which provides free Omnipod 5 or Omnipod DASH products, including Controller/PDM and Pods to benefit eligible employees or dependents.
Health and Safety
We have high standards for workplace safety and are committed to the safety and well-being of our workforce. To promote this, we maintain an environmental health and safety management system that covers all our employees, temporary employees, and contractors. Our programs and policies are designed to meet all applicable local, regional, and federal laws, including U.S. Occupational Safety and Health Administration requirements. We continuously monitor and adapt to regional regulations as we expand our facilities into new geographies.
We have formal plans in place to protect our employees' safety in the event of an emergency. We also conduct periodic health and safety audits of our facilities to monitor the effectiveness of our programs and drive continuous improvement in our overall safety performance as Insulet expands in size and impact.
Company Information
Insulet Corporation is a Delaware corporation formed in 2000. Our principal office is located at 100 Nagog Park, Acton, Massachusetts, 01720 and our website address is http://www.insulet.com . We make available free of charge on our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and amendments to those reports as soon as reasonably practicable after we electronically file or furnish such materials to the U.S. Securities and Exchange Commission (“SEC”). We have also posted the charters for our Audit Committee, Talent and Compensation Committee, Nominating, Governance and Risk Committee, and Science and Technology Committee as well as our Code of Business Conduct and Ethics, and other corporate governance materials under the heading “Governance Documents” in the Investors section of our website. The information on our website is not incorporated in this report by reference. In addition, the SEC maintains a website ( http//www.sec.gov ) that contains reports, proxy, and information statements, and other information regarding issuers that file electronically with the SEC.
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Item 1A. Risk Factors
Risks Related to Our Business
We currently rely on sales of our Omnipod product platform to generate most of our revenue.
We expect to continue to derive nearly all our revenue from our Omnipod product platform. Accordingly, our ability to continue to generate revenue is highly reliant on our ability to successfully market and sell our Omnipod products to new and existing customers, which could be negatively impacted by the risks described throughout these Risk Factors. Failure to continue to successfully market and sell our Omnipod products or to retain and grow our customer base would have a negative impact our business, revenue, financial condition and results of operations.
Our ability to grow our revenue depends in part on our retaining a high percentage of our customers.
A key to driving our revenue growth is the retention of a high percentage of our customers. If demand for our products decreases as a result of economic conditions, competition, perceived inadequate customer service, product performance issues or otherwise, our ability to retain customers could be harmed. The failure to retain a high percentage of our customers would negatively impact our revenue growth and may have a material adverse effect on our business, financial condition, and results of operations.
If we do not effectively manage our rapid growth, our business resources may become strained and we may not be able to deliver our products in a timely manner, which could adversely affect our results of operations.
As we continue to expand the number of customers we serve, driven by increasing demand for Omnipod 5, our international expansion and entrance into the insulin-requiring type 2 diabetes market, we expect to continue to increase our manufacturing capacity, our personnel, and the scope of our sales and marketing efforts. Our growth will create challenges for our organization and may strain our management, operations, and customer service resources. We may misjudge the amount of time or resources that will be required to effectively manage any anticipated or unanticipated growth in our business, we may not be able to manufacture sufficient inventory, and we may not be able to attract, hire, and retain sufficient personnel to meet our expanding needs. If we cannot scale our business appropriately, maintain control over expenses, manufacture our products in a cost-effective or timely manner, or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, customer experience may decline, and we may not be able to deliver our Omnipod products in a timely manner, all of which would adversely affect our results of operations.
Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could adversely affect our business, revenue, financial condition, and results of operations.
We expect that sales of our Omnipod products would be limited if a substantial portion of their sales price is not paid for by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, Medicaid, and other managed care providers. In the United States, we currently have contracts establishing reimbursement for Omnipod products with national and regional third-party payors and government agencies that provide reimbursement in all 50 states. Medicare Part D Plan Sponsors may provide coverage for Omnipod products under the Medicare Part D prescription drug program, which requires negotiating with third-party payors in order to provide our product through the pharmacy channel in the United States. While we anticipate entering into additional contracts with other intermediaries and third-party payors, we cannot be sure that our efforts will be successful or that we will be able to maintain these contracts as they can generally be terminated by the third-party payor without cause. Further, we anticipate that recently enacted and proposed legislative changes affecting Medicare, Medicaid, and the Affordable Care Act may impact healthcare coverage, which, if implemented could adversely affect both demand for and pricing of our products.
Moreover, compliance with administrative procedures or requirements of third-party payors may result in delays in the payor processing approvals for coverage of Omnipod products. Coverage decisions and rates of reimbursement increasingly require clinical evidence showing an improvement in user outcomes. Generating this clinical evidence requires substantial time and investment and there is no guarantee of a desired outcome.
As we expand our sales and marketing efforts internationally, we face additional risks associated with obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all. Guidelines for reimbursement vary from jurisdiction to jurisdiction and we may not have the needed experts or clinical evidence within a particular jurisdiction to achieve reimbursement and thereby patient access. Outside the U.S., several of our major markets have government involvement in their healthcare payment system that may impose negative pricing pressure or limit access to or reimbursement for our products. Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could limit our ability to expand internationally and have a material adverse effect on our business, revenue, financial condition, and results of operations.
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If we fail to expand our relationships with intermediaries, our ability to grow our business may be materially and adversely affected.
In addition to promoting, marketing, and selling Omnipod products through our own direct sales force, we utilize intermediaries to distribute our product. If our intermediaries are unwilling or unable to market and sell our products, do not devote adequate resources or support to generate awareness of our products and grow product sales, or if they do not perform to our expectations, we could experience delayed or reduced market acceptance and sales of our products, which would adversely affect our business, revenue, financial condition, and results of operations.
Our non-insulin Drug Delivery product line faces challenges which, if not met, may impair its future success.
Our non-insulin Drug Delivery product line involves the development, manufacture, and sale of a modified Pod for delivery of a specific drug other than insulin. Substantially all of our commercialized Drug Delivery revenue consists of sales of a customized version of our product for use in Amgen’s Neulasta Onpro kit under an agreement that expires in December 2028. The marketing and sales initiatives driving this product line differ markedly from those on which we rely for our sales of Omnipod products to treat diabetes since the non-insulin drug delivery devices depend on marketing and sales to pharmaceutical companies, not to users and clinicians. We expect that the future results of our Drug Delivery product line will face several challenges, including:
• our identification of opportunities and development of appropriate modifications to our Omnipod technology to address the needs and parameters required for drug-delivery opportunities;
• our achievement of satisfactory development and pricing terms with the pharmaceutical companies that sell such drugs that would enable us to maintain an appropriate gross margin, particularly given relatively small number of modified Pods needed to address each drug-delivery opportunity;
• our ability to manufacture, and possible long lead-times associated with the development, regulatory approvals, and ramp up applicable to modified Pods;
• uncertainties relating to the success of the pharmaceutical companies in marketing and selling their drugs as well as the modified Pods as the appropriate delivery devices;
• intense competition in the drug-delivery industry, including from competitors which have substantially greater resources; and
• regulatory requirements and reimbursement rates associated with such drugs.
If we are unsuccessful in overcoming one or more of these challenges, or if our agreement with Amgen is terminated or not renewed, our financial results could be negatively impacted.
Risks Related to Competition and Product Development
Our failure to compete effectively would negatively impact our revenue and results of operations.
The competitive landscape in our industry continues to undergo significant change. We compete with established companies that produce insulin pumps, such as Medtronic Diabetes, a division of Medtronic plc (which division is being spun out into a new, independent publicly traded company), Tandem Diabetes Care Inc., as well as emerging companies like Beta Bionics Inc. Our competitors may develop products in the future that are superior to ours which would inhibit our ability to compete effectively.
In addition to the insulin pump competitors, we compete with companies that provide products and supplies for MDI therapy. MDI therapy, including smart pens, can be substantially less expensive than pump therapy, and improvements in the effectiveness of MDI therapy may result in fewer people than we expect converting from MDI therapy to pump therapy, which could result in price pressure and decreased revenue.
Our current competitors or other companies may at any time develop additional products for the treatment of diabetes. Several companies are working to develop and market new insulin “patch” pumps, smart pens, and other methods for the treatment of insulin-dependent diabetes. If an existing or future competitor develops a product that competes with or is superior to our Omnipod products, we risk losing our position as the perceived technology leader in our field, and our revenue may decline.
In addition, some of our competitors may compete by changing their pricing model or by lowering the price of their insulin delivery systems or ancillary supplies. If these competitors’ products gain acceptance by healthcare professionals, people with insulin-dependent diabetes, or third-party payors, we could experience pricing pressure. If prices were to fall, our results of operations could be materially adversely impacted.
Additionally, diabetes associations, healthcare providers 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.
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Our new product development initiatives may prove to be ineffective or not commercially successful.
A significant element of our strategy is to increase revenue growth by continuing to focus on innovation and new product development. The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, successfully complete clinical trials, obtain regulatory approvals and reimbursement in the U.S. and abroad, gain and maintain market acceptance of our products, manufacture products in a cost-effective manner, and obtain appropriate intellectual property rights. Further, governmental regulation and laws related to AI and other emerging technologies may increase the burden and cost of research and development or require increased transparency that makes it more difficult to protect our intellectual property. In addition, patents attained by others can preclude or delay our commercialization of a product. There can be no assurance that any products currently in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval, or gain market acceptance. If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted. Even if we successfully develop new products, enhancements, or new generations of existing products, they may be quickly rendered obsolete by changing customer preferences, changing industry or regulatory standards, or competitors’ innovations. Our failure to introduce commercially successful new and innovative products in a timely manner could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
Technological breakthroughs in diabetes monitoring, treatment, or prevention could render our Omnipod products obsolete or less desirable.
The diabetes treatment market is subject to rapid technological change and product innovation. Our Omnipod products are based on our proprietary technology, but a number of companies, medical researchers, and pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs, and other therapeutics for the monitoring, treatment, and/or prevention of insulin-dependent diabetes. In addition, well-capitalized biopharmaceutical companies like Vertex Pharmaceuticals, as well as the National Institutes of Health, and other supporters of diabetes research, are continually seeking ways to prevent, cure, or improve the treatment of diabetes. Any breakthroughs in diabetes monitoring, treatment, or prevention could reduce the potential market for our products or render our products obsolete altogether, which would significantly reduce our sales or cause our sales to grow at a slower rate than we currently expect. Further, increased availability and adoption of the GLP-1 class of drugs may delay the progression of type 2 diabetes in obese patients. 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 or impact our stock price.
Future market or clinical studies may be unfavorable to our Omnipod 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 Omnipod products, we have sponsored, and expect to continue to sponsor, clinical 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. If 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 or reimbursement from third-party payors. In addition, 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. Any of these events may have a material adverse effect on our business, financial condition, and results of operations.
Risks Related to our Intellectual Property
We may be unable to adequately protect our intellectual property rights, which could limit our ability to sell our products profitably, or at all, and cause us to incur additional costs.
Our success depends in part on our ability to develop or acquire commercially valuable intellectual property rights and to protect those rights adequately. We rely on a combination of patents, trade secrets, copyright and trademark laws, confidentiality, non-disclosure and assignment of invention agreements, and other contractual provisions and technical measures to protect our intellectual property rights. Despite these measures, any of our intellectual property rights could be challenged, invalidated, circumvented, or misappropriated. Companies could produce competing products using the stolen intellectual property and counterfeit products could also be developed. The latter could be damaging to our reputation if the products do not work properly.
We may not be able to develop additional proprietary technologies that are patentable, and we cannot ensure that our pending patent applications will result in the issuance of patents to us. To protect our intellectual property, we may need to assert claims of infringement or misappropriation against third parties. Any lawsuits that we initiate could be expensive, take significant time,
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and divert management’s attention from other business concerns. The outcome of litigation to enforce our intellectual property rights, including the award of damages or other remedies (if any) is highly unpredictable. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially valuable. The occurrence of any of these events could limit our ability to sell our products profitably or at all, or to effectively compete, resulting in a material adverse effect on our business, revenue, financial condition, and results of operations.
Claims that our current or future products infringe or misappropriate the proprietary rights of others could adversely affect our ability to sell those products and cause us to incur additional costs.
We have been involved in patent infringement suits in the past and may be again in the future. As the number of companies with whom we compete grows and the functionality of products and technology in different industry segments overlap, the risk of third-party infringement claims increases. Third parties may currently have, or may eventually be issued, patents related to our current or future products or technologies and any of these third parties might make a claim of infringement against us.
Such litigation, regardless of its outcome, could result in the expenditure of significant financial resources and the diversion of management’s time and resources. In addition, such litigation could cause negative publicity, cause product shipment delays, temporarily or permanently limit or prohibit us from manufacturing, marketing, or selling our current or future products, and/or require us to undertake other remedial activities such as develop non-infringing technology, make substantial payments to third parties, or enter into royalty or license agreements, which may not be available on acceptable terms or at all. If a successful claim of infringement were made against us and we could not develop non-infringing technology or license the infringed or similar technology on a timely and cost-effective basis, our revenue could decrease substantially, and we could be exposed to significant liability.
Risks Related to Economic Conditions and Operating Internationally
The continuing worldwide macroeconomic and geopolitical uncertainty as well as the impact of another global pandemic may adversely affect our business and prospects.
Continued concerns about the systemic impact of potential long-term and wide-spread recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and diminished expectations for economic growth in the world. Our business and results of operations may be adversely impacted by changes in macroeconomic conditions, including inflation, bank failures, rising interest rates, and reduced availability of capital markets. Elections, political changes and divisions, and social concerns in various countries, including the United States, may further exacerbate geopolitical and geoeconomic tensions and market instability. Uncertainty about global economic conditions, particularly in countries with government-sponsored healthcare systems, may also cause slower adoption of new technologies such as Omnipod 5. Our failure to effectively navigate these geopolitical and economic challenges may result in decreased demand for our products and increased competition, downward pricing pressure, and increased user attrition, which could have a material adverse effect on our business, revenue, financial condition, and results of operations.
A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply. In addition, another global pandemic like COVID-19 could significantly impact our supply chain if the manufacturing plants that produce our products or product components, the distribution centers where we manage our inventory, or the operations of our logistics and other service providers, including third parties that sterilize our products, are disrupted, temporarily closed, or experience worker shortages for a sustained period of time, which could have a material adverse effect on our business, revenue, financial condition, and results of operations.
The international nature of our business subjects us to additional business risks that may have an adverse effect on our financial condition or results of operations.
International expansion is a key component of our growth strategy. International sales made up 28% of our revenues in 2025, and we expect international sales to contribute significantly to our future growth as we continue to launch Omnipod 5 in additional international markets. We also rely on third-party suppliers located in other countries, a third-party contract manufacturer located in China, and our manufacturing facility in Malaysia. Our current and future international operations are subject to risks that are inherent in conducting business under foreign laws, regulations, and customs.
Our international operations, particularly our sales, manufacturing and supplier operations, may subject us to a number of risks and expenses, any of which could harm our operating results, including:
• political instability and actual or anticipated military or political conflicts;
• trade protection measures, such as tariff increases, and import and export licensing and control requirements;
• negative consequences from changes in, or interpretations of, tax laws;
• currency fluctuation;
• difficulty in establishing, staffing, and managing international operations;
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• adapting to the differing laws and regulations, business and clinical practices, and consumer preferences in international markets;
• difficulties in obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all;
• difficulties in managing international relationships, including any relationships that we establish with foreign partners, distributors, or sales or marketing agents; and
• longer collection periods and difficulty in collecting accounts receivable.
In addition, government policies on international trade and investment such as import quotas, capital controls or tariffs, whether adopted by individual governments or addressed by regional trade blocks, can affect the cost of and the demand for our products, impact the competitive position of our products, or otherwise adversely affect our ability to sell products in the affected countries. The implementation of more restrictive trade policies, such as more detailed inspections, higher tariffs, or new barriers to entry, could negatively impact our business, results of operations, and financial condition. For example, a government's adoption of “buy national” policies or retaliation by another government against such policies could have a negative impact on our results of operations.
Expansion of U.S. tariffs could have a material adverse effect on our financial results.
Tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact our supply chain costs or availability of certain components, demand for our products and our business, revenue, financial condition, results of operations and cash flows. Unpredictability of trade policy compounds this risk. Further, the U.S. Department of Commerce Bureau of Industry and Security (“BIS”) has announced the initiation of an investigation into the effects on U.S. national security of imports of personal protective equipment, medical consumables, and medical equipment, including medical devices such as insulin pumps. BIS is conducting the investigation under Section 232 of the Trade Expansion Act of 1962 (Section 232), a law that empowers the president to restrict imports of products that threaten to impair national security. The investigation could result in overriding the tariff exemption currently in place for certain medical devices, which could have a material impact on our results of operations in future years.
Risks Related to Reliance on Third Parties and Business Continuity
We rely on agreements or licenses to intellectual property or other rights in order to sell our current product and commercialize new products.
We rely on agreements or licenses to intellectual property or other rights in order to sell our current products and commercialize new products. If we cannot obtain or retain these agreements, licenses, or other rights, we may not be able to sell, develop, or commercialize our products. For example, we have commercial agreements with Dexcom and Abbott that allow us to sell Omnipod 5 with integration to Dexcom’s and Abbott’s CGM sensors. The loss of any of these rights could impair the functionality of our products or prevent us from selling our products without significant development activities and regulatory approvals that may not be completed in time to prevent an interruption in the availability of our products to consumers. This could result in a material adverse effect on our business, revenue, financial condition, and results of operations.
We also have a partnership with Glooko that allows our products to connect with Glooko’s cloud-based diabetes data management system so that users and healthcare providers can monitor user data, including insulin delivery trends, and blood glucose levels. Our agreement with Glooko expires in December 2026. If this agreement is not renewed in the future and we do not contract for an alternative data management system or launch our own, our business could be materially adversely impacted.
Our inventory is produced and maintained in a limited number of locations, including one operated by a third party in China, and any loss could have a material adverse effect on our ability to manufacture and sell our products.
Our products are manufactured in three locations: at our manufacturing facility in the United States, at our manufacturing facility in Malaysia, and on manufacturing lines owned by us at a facility located in China that is operated by a third-party contract manufacturer. Political or financial instability, currency fluctuations, the outbreak of pandemics, labor unrest, impaired transport capacity and costs, port security, weather conditions, natural disasters, or other events that could slow or disrupt port activities and affect foreign trade are beyond our control and could materially disrupt our supply of product from China or Malaysia, increase our costs, and/or adversely affect our results of operations. Further, following the COVID-19 pandemic there may be increased pressure for U.S. medical device companies to reduce dependency on China for their supply chain. In addition, substantially all of our inventory in the United States is held at a single location in Massachusetts and our inventory in Europe is maintained by a third-party logistics entity primarily at a single location in the Netherlands. We take precautions to ensure that our third-party contract manufacturer and logistics entity safeguard our assets, including maintaining insurance, enacting health and safety protocols, and storing computer data offsite. However, a natural or other disaster, such as a fire or
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flood, could cause substantial delays in our operations, damage or destroy our manufacturing equipment and/or inventory, and cause us to incur additional expenses. Further, the insurance we maintain may not be adequate to cover our losses. With or without insurance, damage to our facility, manufacturing equipment, inventory, or other property, or to any of our suppliers, may have a material adverse effect on our business, financial condition, and results of operations.
We are dependent upon third-party suppliers, making us vulnerable to supply constraints and price fluctuations, and we may not be able to obtain sufficient components or raw materials on a timely basis or at all.
The manufacture of our products requires the timely delivery of sufficient amounts of quality components and materials from many suppliers in various countries. We work closely with our suppliers to ensure the continuity of supply, but we cannot guarantee these efforts will always be successful. We have also seen significant price increases for various components and raw materials, including for semiconductor chips. We do not have long-term supply agreements with all of our suppliers, and, in many cases, we, or our contract manufacturer, make purchases based on individual purchase orders. In some cases, our agreements with suppliers can be terminated by either party upon short notice. Additionally, while efforts are made to diversify our sources of components and materials, in certain instances we acquire components and materials from a sole supplier. Also, due to the stringent regulations and requirements of the FDA and similar regulatory agencies in other countries regarding the manufacture of our products, we may not be able to quickly establish additional or replacement sources for some components or materials.
Our reliance on third-party suppliers subjects us to other risks that could harm our business, including:
• our suppliers may give other customers’ needs higher priority than ours, impacting their ability to deliver products to us in a timely manner, as we are not a major customer of many of our suppliers;
• we may not be able to obtain an adequate supply of materials or components in a timely manner or on commercially reasonable terms;
• our suppliers may make errors in manufacturing that could negatively affect the safety or efficacy of our products, cause delays in shipment, or negatively affect our reputation;
• we may have difficulty locating and qualifying alternative suppliers for our sole-source supplies;
• switching components or suppliers may require product redesign and submission to the FDA of a new 510(k);
• thefts of our trade secrets and intellectual property could occur with the third-party supply process;
• our suppliers may be unable to fulfill our orders in a timely manner or at all due to financial hardship or the occurrence of a fire, natural disaster, or other catastrophe; and
• our suppliers may fail to comply with environmental, conflict minerals, anti-slavery, or other applicable laws, thus impairing our ability to source materials.
An interruption, delay, or inability to obtain components, products, and raw materials from our third-party suppliers at acceptable prices and in a timely manner, could hinder our ability to manufacture our products in a timely or cost-effective manner and have a material adverse effect on our business and results of operations.
Our manufacturing process is highly complex and subject to regulation; as demand for our products increase, we may experience manufacturing difficulties, including not effectively managing the start-up of new manufacturing lines or issues with our third-party contract manufacturer, which could harm our business.
The manufacture of our product is highly exacting and complex, due in part to strict regulatory requirements. While we manufacture our products in the United States and in Malaysia, a third-party contract manufacturer in China manufactures and supplies a significant portion of our inventory. We and our contract manufacturer may encounter problems during manufacturing for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, defective raw materials, and environmental factors. These issues could lead to compromised product quality, launch delays, reduced productivity, higher defect rates, increased waste, product shortage, unanticipated or increased costs, lost revenues, and damage to our reputation. Our failure to scale manufacturing appropriately to meet future demand, or encountering quality issues or unexpected operational delays when commencing operation of new manufacturing lines, would have an adverse effect on our gross margins and could result in product shortages. A failure to identify and address manufacturing problems prior to the release of products to our customers may also result in a quality or safety issue. Additionally, inefficient processes can strain relationships with suppliers and partners, further exacerbating operational disruptions and financial losses. Significant manufacturing problems could have a material adverse effect on our business, results of operations, financial condition, and cash flows.
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If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval or commercialize our products.
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, 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, and our business and operating results may be adversely affected.
Risks Related to Government Regulation and Product Liability
Healthcare reform laws could adversely affect our revenue and financial condition.
Efforts to control healthcare costs, including limiting access to care, alternative delivery models, and changes in the methods used to determine reimbursement systems and rates, are ongoing at the federal and state levels. Future changes cannot be predicted with certainty, and may have an adverse effect on our industry and on our ability to maintain or increase sales of any of our products.
We are subject to extensive government regulation, which could restrict the sales and marketing of our products, cause us to incur significant costs, and impact our profitability and competitiveness.
Our medical device products and operations are subject to extensive regulation by the FDA and various other federal, state, local, and foreign government authorities. Government regulation of medical devices is meant to ensure their safety and effectiveness, and includes regulation of, among other things:
• design, development, and manufacturing;
• testing, labeling, and content and language of instructions for use and storage;
• clinical trials;
• product clearances and approvals, including premarket clearance and approval;
• product safety;
• advertising and promotion;
• marketing, sales, and distribution;
• conformity assessment procedures;
• product traceability and record keeping procedures;
• product complaints, complaint reporting, recalls, and field safety corrective actions;
• post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury;
• post-market studies; and
• product import and export.
Before a new medical device, or a significant modification of a medical device, including a new use of or claim for an existing product, can be marketed in the United States, it must first receive regulatory clearance, unless an exemption applies. Obtaining such regulatory clearance can be expensive and lengthy. Delays in obtaining or inability to obtain clearances could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn could harm our revenue and profitability.
We also are subject to numerous post-marketing regulatory requirements, which include quality system regulations related to the manufacture of our devices, labeling regulations, and medical device reporting regulations. The last of these regulations requires us to report to the FDA if our devices cause or contribute to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury if the malfunction recurred. If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by the FDA, which may include any of the following sanctions:
• untitled letters, warning letters, fines, injunctions, consent decrees, and civil penalties;
• customer notification or orders for repair, replacement, or refunds;
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• voluntary or mandatory recall or seizure of our current or future products;
• administrative detention by the FDA of medical devices believed to be adulterated or misbranded;
• operating restrictions or suspension or shutdown of production;
• refusing our requests for regulatory clearance of new products, new intended uses, or modifications to our Omnipod products;
• rescinding, suspending, or withdrawing clearance that has already been granted; and
• criminal prosecution.
The occurrence of any of these events may have a material adverse effect on our business, financial condition, and results of operations.
In addition, the FDA may change its clearance and approval policies, adopt additional regulations, revise existing regulations, or take other actions that may prevent or delay approval or clearance of our products under development or impact our ability to modify our currently approved or cleared products on a timely basis or make it more difficult and costly to produce, market, and distribute existing products.
We also sell our products in Canada, Australia, and certain countries in Europe and the Middle East. As a result, we are required to comply with additional foreign regulatory requirements, which may vary substantially from country to country. As we expand our sales efforts internationally, we may need to obtain additional foreign approval certifications. Failure to fulfill foreign regulatory requirements on a timely basis or at all could adversely affect our ability to grow our business.
Any delays in obtaining approval for our products, or any failure to meet regulatory requirements could adversely affect our ability to sell our products resulting in a negative impact to our financial results.
If we or our contract manufacturer fail to comply with the FDA’s quality system regulations, the manufacturing and distribution of our devices could be interrupted, and our sales and operating results could suffer.
We and our contract manufacturer are required to comply with the FDA’s QSR, which is a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, sterilization, labeling, packaging, storage, shipping, and servicing of our devices. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic, sometimes unannounced, inspections by the FDA. We cannot assure you that our facilities or our contract manufacturer’s facility will pass any future quality system inspection. If our or our contract manufacturer’s facility fails a quality system inspection or fails to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation, or otherwise fails to adhere to QSR requirements, this could delay production of our products and lead to business disruption. In addition, failure to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation could result in fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could have a material adverse effect on our customers’ experience and our financial condition or results of operations.
Malfunction of our products could lead to recalls, safety alerts, or litigation and result in substantial costs and reputational damage.
The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our contract manufacturer fails to comply with relevant regulations pertaining to manufacturing practices, labeling, advertising, or promotional activities, or if new information is obtained concerning the safety or efficacy of our products. A government-mandated recall could occur if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. A voluntary recall by us could occur as a result of any material deficiency in a device, such as manufacturing defects, labeling deficiencies, packaging defects, or other failures to comply with applicable regulations. Adverse events involving our products have been reported to us in the past, and we cannot guarantee that they will not occur in the future. Any corrective action, whether voluntary or involuntary, may require significant time and capital, could divert management's attention from operating our business, and may harm our reputation and financial results. We may initiate voluntary recalls involving our products in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, it could require us to report those actions as recalls and could take enforcement action against us for failing to report the recalls when they were conducted. In the event of a product malfunction, we may also be subject to liability claims, be required to bear other costs, or take other actions that may have a negative impact on our future sales and our ability to generate profits.
We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of unapproved, or off-label, use. Doctors may prescribe our products off-label, as the FDA does not restrict or regulate a doctor’s choice of treatment within the practice of medicine. However, if the FDA determines that
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our promotional materials or training constitutes promotion of an off-label use, it could subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine, or criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of our products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree with our characterization of certain statements and conclude that we have engaged in off-label promotion. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could divert management’s attention, result in substantial damage awards against us, and harm our reputation.
If we fail to comply with fraud and abuse and other healthcare regulations, including those relating to Medicare and Medicaid, we could be subject to substantial penalties and/or be excluded from participation in government programs.
Our relationships with customers and third-party payors are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our sales, marketing, and other promotional activities by limiting the kinds of financial arrangements, including sales programs and certain customer and product support programs, we may have with hospitals, physicians, customers, or other potential purchasers of medical devices. These laws include, among others, the federal healthcare Anti-Kickback Statute, the federal civil False Claims Act, other federal healthcare false statement and fraud statutes, the Open Payments program, the Civil Monetary Penalties Law, and analogous fraud and abuse and transparency laws in most states, as described in “Item 1—Business—Government Regulation.”
We conduct various marketing and product training activities that involve making payments to healthcare providers and entities. While we believe and strive to ensure that our business arrangements with third parties and other activities and programs comply with all applicable laws, these laws are complex and our activities may be found not to be compliant with one of these laws, which may result in significant civil, criminal, and/or administrative penalties, fines, damages, and exclusion from participation in federal healthcare programs. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to, and thus could have a material adverse effect on our business, financial condition, and results of operations. Our compliance with Medicare and Medicaid regulations may be reviewed by federal or state agencies, including the OIG, CMS, and the Department of Justice, or may be the subject of whistleblower lawsuits under federal and state false claims laws. To ensure compliance with Medicare, Medicaid, and other regulations, government agencies conduct periodic audits of us to ensure compliance with various supplier standards and billing requirements.
Failure to comply with the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws could materially adversely affect our business and result in civil and/or criminal sanctions.
The FCPA, the U.K. Bribery Act, and similar anti-bribery laws enacted in other jurisdictions generally prohibit companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining or retaining business. Because of the predominance of government-sponsored healthcare systems around the world, most of our customer relationships outside of the United States are with governmental entities and are therefore subject to such anti-bribery laws. Because we do business in the United Kingdom, the U.K. Bribery Act also extends to our interaction with public and private sector entities and persons outside the United Kingdom, including in the United States. Our policies mandate compliance with these anti-bribery laws. We operate in parts of the world that have experienced governmental corruption to some degree, and in certain circumstances strict compliance with anti-bribery laws may conflict with local customs and practices. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees or agents. Violations of anti-bribery laws, or allegations of such violations, could disrupt our business and have a material adverse effect on our results of operations, financial condition, and cash flows.
Risks Related to Information Technology (“IT”) , Privacy and Security
We are subject to complex and evolving laws and regulations regarding privacy, data protection, and artificial intelligence (“AI”), many of which are subject to change and uncertain interpretation, which could result in legal claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement.
We are subject to a variety of laws and regulations relating to privacy, data protection, and AI. The introduction of new products or expansion of our activities in certain jurisdictions may subject us to additional laws and regulations. For example, data privacy laws at the federal and state levels protect the confidentiality of certain health information and restrict the use and disclosure of that protected information. In particular, the U.S. privacy rules under HIPAA protect medical records and other personal health information by limiting their use and disclosure, giving individuals the right to access, amend, and seek accounting of their own health information, and limiting most uses and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose. Many states have adopted new privacy laws in the past few
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years. For example, CCPA and CPRA provide privacy rights and consumer protection for residents of California, including the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request a company to delete the personal information collected, the right to opt-out of the sale of personal information, and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right. The California laws have served as a model for many subsequently adopted laws in other states, such as Colorado and Virginia. California and other states’ laws apply more broadly and now or in the future may reach data we hold that relates to employees and healthcare providers, not just customers. In addition, data security protection laws passed by the federal government and many states require notification to data subjects, including customers and others, when there is a security breach of personal data. If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance.
We develop, license from other developers, and deploy AI tools, including generative AI tools for use in our operations. Our teams collaborate on the development of responsible AI policies and practices and deployment of AI tools in accordance with those policies and practices, which are in turn based on relevant laws and standards, including the EU AI Act (which is taking effect in stages, through August 2026). While we anticipate being able to capitalize on opportunities using AI tools, including generative AI tools, to improve efficiencies and create more personalized experiences, doing so is not without risk. Risks include potential inappropriate disclosure of personal and confidential information, and potential use of inaccurate information contained in generative AI outputs. In addition, foreign data protection, privacy, and other laws and regulations can be more restrictive than those in the United States. Data localization laws in some countries generally mandate that certain types of data collected in a particular country be stored and/or processed within that country. We could be subject to audits in Europe and around the world, particularly in the areas of consumer and data protection, as we continue to grow and expand our operations. Legislators and regulators may make legal and regulatory changes or interpret and apply existing laws in ways that make our products less useful to users, require us to incur substantial costs, expose us to unanticipated civil or criminal liability, or cause us to change our business practices. These changes or increased costs could materially and adversely affect our business and results of operations. For example, the GDPR imposes requirements in the European Economic Area relating to among other things, consent to process personal data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches, and use of third-party processors. If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including significant fines and penalties.
The increased scope of regulation around the world may require expanded compliance programs and resources. As our efforts to gain insights from data increase for the operation of our products and services and for the improvement of business processes, including sales and marketing, our exposure to increasingly complex privacy regulation may impede our ability to use data in this way.
We rely on the proper function, availability, and security of our products and IT systems; a successful cyber-attack or other breach or disruption of our products or these systems could have a material adverse effect on our business and results of operations.
We rely on IT systems to process, transmit, and store electronic information, including personal, financial, and sensitive medical information. Our IT systems support various business processes, including sales, shipping, billing, customer service, procurement, supply chain, manufacturing, and accounts payable. In addition, we use enterprise IT systems for internal financial reporting and to comply with external financial reporting, legal, and tax regulatory requirements. Many of our systems are cloud-hosted and managed by third-party vendors who may have access to confidential business, employee, healthcare professional, and/or customer information. Our IT systems are vulnerable to damage, disruptions, or shutdowns due to various factors such as viruses, hacking, power outages, user error, hardware failures, and catastrophic events. Failure to protect our IT systems could lead to unauthorized access to customer data, theft of intellectual property or other misappropriation of assets, loss of key data, or disruption of operations. Further, we expect that the breadth and complexity of our IT systems and infrastructure will increase as we utilize cloud technologies and AI, which present inherent enterprise technology risks, including those related to privacy, data protection, and cybersecurity, that need to be managed. The foregoing could expose us to further risk of potential breaches, failures, interruptions, and disruptions, which could result in adverse consequences, including regulatory inquiries or litigation, increased costs and expenses, reputational damage, lost revenue, and fines or penalties.
If our product is breached or our IT systems are breached or suffer severe damage, disruption, or shutdown and we are unable to effectively resolve the issues in a timely manner, our reputation, business, and operating results may be materially adversely affected.
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Failure to maintain the privacy and security of our customer, third-party payor, employee, supplier, or Company information could result in substantial costs and/or subject us to litigation, enforcement actions, and reputational damage.
Our business, like that of most medical device manufacturers, involves the receipt, storage, and transmission of customer information, payment and reimbursement information, and confidential information about third-party payors, our employees, our suppliers, and our Company. Our information systems are vulnerable to an increasing threat of continually evolving cybersecurity risks. Unauthorized parties may attempt to gain access to our systems or information through fraud or other means of deceiving our employees or third-party service providers. Hardware, software, or applications we develop or obtain from third parties may contain defects in design or manufacture, or other issues that could unexpectedly compromise information and device security. The methods used to obtain unauthorized access, disable or degrade service, or sabotage systems are also constantly changing and evolving, and may be difficult to anticipate or detect for long periods of time. We have implemented, and regularly review and update, processes and procedures to protect against unauthorized access to or use of secured data and to prevent data loss. However, ever-evolving threats mean we must continually evaluate and adapt our systems and processes. Our efforts may not be adequate to safeguard against all data security breaches, misuse of data, or sabotage of our systems. Any future significant compromise or breach of our data security, whether external or internal, or misuse of customer, third-party payor, employee, supplier, or Company data, could result in significant costs, lost sales, fines, lawsuits, and damage to our reputation.
Risks Related to Debt
Our Credit Agreement imposes restrictions on us that may adversely affect our ability to operate or grow our business.
Our Credit Agreement contains covenants that restrict our ability, and that of our subsidiaries, to engage in certain transactions, including, among other things, limitations on our ability to incur additional indebtedness, make asset dispositions, create or permit liens, sell, transfer, or exchange assets, guarantee certain indebtedness, and make acquisitions or other investments. These restrictions may impair our ability to respond to changing business and economic conditions and may make it more difficult for us to obtain additional capital and pursue business opportunities, including potential acquisitions.
We may need to raise additional funds in the future, and these funds may not be available on acceptable terms or at all.
We may in the future seek additional funds from public or private stock or debt offerings, borrowings under credit lines, or other sources, and we may need to raise additional debt or equity financing to repay our outstanding debt obligations. If we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, and the new equity or debt securities may have rights, preferences, and privileges senior to those of our existing stockholders. In addition, if we raise additional funds through collaboration, licensing, or other similar arrangements, it may be necessary to relinquish valuable rights to our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us. Our ability to raise additional capital may be adversely impacted by economic conditions, including inflation, higher interest rates, and worldwide political unrest, and we may not be able to raise any necessary capital on acceptable terms, or at all. If we are unable to raise additional capital due to these or other factors, such as a worldwide or U.S. financial crisis, we may need to further manage our operational expenses, including potentially curtailing planned product development activities. In addition, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated customer requirements. If any of these events occur, it could adversely affect our business, financial condition, and results of operations.
General Risks
Our success depends on our ability to attract, motivate, and retain key personnel.
As Insulet continues to quickly grow, our success is highly dependent on attracting the right talent, retaining our employees, and keeping them engaged and focused on our mission. In 2025, we had changes in key leadership roles, including our Chief Executive Officer and Chief Financial Officer, among others. If we are unable to effectively integrate the new members of the management team, retain other key members of our team, and maintain continuity in critical functions, our business, financial condition, and results of operations could be adversely affected.
In addition, the sales and after-sale support of Omnipod products require a complex infrastructure of field sales personnel, diabetes educators, customer support, insurance specialists, and billing and collections personnel. Recruiting, training, managing, motivating, and retaining these employees, especially in international and geographically dispersed teams, presents challenges. If we are unable to successfully recruit or retain employees as needed, we could experience significant operational disruptions, which could in turn negatively impact our customers, our reputation, and our financial condition.
Acquisitions or investments in new businesses, products, or technologies could disrupt our business.
If we are presented with appropriate opportunities, we may pursue acquisitions or investments in complementary businesses, products, or technologies. If we do so, we may not complete transactions in a timely manner, on a cost-effective basis, or at all,
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and we may not realize the expected benefits of any acquisition or investment. Additionally, products and technologies that we acquire may not be successful or may require significantly greater resources and investments than we originally anticipated. We could also experience negative effects on our results of operations and financial condition due to acquisition-related charges, amortization of intangible assets, and asset impairment charges. Acquisitions also present risks, uncertainties, and disruptions associated with the integration process, including difficulties in the integration of the operations of any acquired company, integration of acquired technology with our products, and the potential loss of key employees, customers, distributors, or suppliers of the acquired businesses. In addition, integration of an acquired business may require management resources that otherwise would be available for development of our existing business. If an acquired business fails to operate as anticipated or cannot be successfully integrated into our existing business, our stock price, business, financial condition, and results of operations could be materially and adversely affected. Furthermore, we may have to incur debt or issue equity to pay for any future acquisitions or investments, the issuance of which could be dilutive to our existing stockholders.
The price of our common stock may be volatile.
The market price of our common stock is affected by a number of factors, including factors related to our operating performance as a high-growth company and the operating performance of our competitors. At times, the fluctuations in the market price of our common stock have been unrelated or disproportionate to our operating performance. In particular, the U.S. equity markets have at times experienced significant price and volume fluctuations that have affected the market prices of equity securities of many medical device and technology companies. Also, in 2023, ongoing adoption of the GLP-1 class of drugs in diabetes and news surrounding the expansion of use of GLP-1 drugs in obesity led to speculation regarding the impact of GLP-1 drugs on the insulin therapy market. We believe this negatively impacted the stock prices of companies in the medical device industry, including ours. Broad market and industry factors such as these could materially and adversely affect the market price of our stock, regardless of our actual operating performance.
Changes in tax laws or exposures to additional tax liabilities could negatively impact our operating results.
We are subject to income taxes, as well as taxes that are not income-based, in both the U.S. and jurisdictions outside of the U.S. Changes in tax laws or regulations in the jurisdictions in which we operate could negatively impact the Company’s effective tax rate, results of operations, and cash flows. In addition, our future effective tax rate could be unfavorably affected by numerous other factors including a change in the interpretation of tax rules and regulations in the jurisdictions in which we operate, a change in our geographic earnings mix, or a change in the measurement of our deferred taxes. We are also subject to ongoing tax audits in various jurisdictions, and tax authorities may disagree with certain positions we have taken and assess additional taxes.
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Risk Management and Strategy
Like other companies, we currently operate in an environment characterized by increasing global cybersecurity vulnerabilities and threats. Accordingly, we have invested in people, processes, and technology aimed at identifying, assessing, and responding to cybersecurity threats. We take a holistic, layered approach to cybersecurity, with a strategy focused on prevention, detection, and mitigation. Our cybersecurity team assesses, monitors, and manages cybersecurity risk through a combination of technical, physical, and administrative controls. These controls include the implementing of cybersecurity policies, procedures, and strategies designed to prevent cybersecurity incidents to the extent feasible and to enhance the resilience of our systems to minimize business impact should a cybersecurity incident occur. We maintain a cybersecurity risk register, and cybersecurity team leaders meet monthly to discuss and prioritize cybersecurity threats, review risk assessments, and monitor progress on remediation activities. We leverage the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework 2.0 to manage and respond to cybersecurity threats. Additionally, Insulet’s information security management system is ISO 27001 and 27701 certified and we hold ISO certifications specific to Cloud Computing and Health Informatics.
Key facets of our cybersecurity program include:
• Ongoing Cybersecurity Threat Monitoring. Our cybersecurity operations centers operate across multiple time zones to support continuous monitoring, enabling timely detection, investigation, and response to cybersecurity threats.
• External Threat Landscape Assessment. Insulet employs multiple third-party threat intelligence services to monitor for cybersecurity threats and cybersecurity incidents. In addition, we participate in a third-party healthcare industry cybersecurity threat intelligence data-sharing organization.
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• Insider Risk Detection. We use targeted third-party tools aimed at detecting insider cybersecurity threats and suspicious data movement.
• Cloud and Vulnerability Management. To enhance cloud and data security, we work to reduce our potential attack surface by establishing secure defaults, implementing least privilege access principles, and continuously monitoring cloud and system configurations. As part of our vulnerability and overall security posture management, a cross-functional team meets regularly to review and remediate issues identified through security scans and security configuration checks. This ongoing effort helps to maintain the security hygiene of our computing devices and supports the resilience of our technology environment.
• Testing and Audits. Regular penetration testing, incident response tabletop testing, and independent audits are performed by third-party cybersecurity consultants and our Internal Audit function. The results of these assessments, including final reports and gap analysis documentation, are reviewed by our cybersecurity team and logged in our risk register, as appropriate.
• Operating Technology (“OT”) Visibility. As a manufacturer of medical devices, the interconnectedness between our OT and other business critical information systems can present material cybersecurity risks. To mitigate these risks, we implement network segmentation, access controls, and OT-specific monitoring capabilities.
• Vendor Management. New vendors and key business partners are subject to our vendor risk assessment process. Once engaged, these vendors are monitored by our third-party threat intelligence tools. Where appropriate, we incorporate security and privacy provisions or contractual addenda to ensure vendors maintain standards consistent with our cybersecurity and data protection requirements to ensure vendors maintain standards consistent with applicable cybersecurity and data protection law as well as our requirements.
• Training and Culture. Training, awareness, and incorporating cybersecurity into our culture is key to reducing risk around common threats such as phishing. All employees are required to complete annual cybersecurity training, supplemented by frequent “nanolearning” modules. These short, targeted trainings are designed to increase awareness of cybersecurity threats among our employees and equip employees with the knowledge and tools needed to recognize and respond appropriately to potential cybersecurity threats. We also conduct phishing simulations to evaluate the effectiveness of our training program with the goal of reducing the percentage of employees who click on suspicious emails.
Our guiding principle of “security and privacy by design” underlies our product development. We have a cybersecurity team embedded within our research and development organization to deliver on this mission as well as a Product Cybersecurity Risk Management Policy that aligns with FDA guidance. Omnipod 5 incorporates cybersecurity by design principles, which includes secure data transfer between the Pod, Controller, cloud storage, and compatible CGMs. We have processes in place to systematically integrate cybersecurity into each phase of our product design and development process. Omnipod 5 is certified by ISO (27001, 27017 and 27799) and the U.K. Cyber Essentials. Omnipod 5 incorporates authentication, encryption, and cybersecurity protection to safeguard against unauthorized devices or individuals accessing its system.
Should a cybersecurity incident occur, we maintain a Cybersecurity Incident Response Procedure (“CIRP”) and Crisis Management Plan designed to support efficient, coordinated, and timely response efforts. Under the CIRP, cybersecurity incidents are initially reviewed and rated by our security operations team. Cybersecurity incidents are rated based on predefined severity levels and escalated to members of our cybersecurity incident response team (“CIRT”) based on the facts and circumstances of the incident. Our CIRT consists of our Chief Information Security Officer (“CISO”), Chief Compliance Officer, Chief Privacy Officer, VP of Commercial Legal, and relevant members of our executive leadership team, including our General Counsel and CEO. When appropriate, such incidents are also reported to the Board of Directors (“Board”) in accordance with our governance protocols. In addition, our internal Disclosure Committee reviews any planned public disclosures or regulatory filings.
Assessing, identifying, and managing cybersecurity-related risks is also integrated into our overall enterprise risk management (“ERM”) program. Cybersecurity risks are included in the risk universe evaluated by the ERM function as it identifies and assesses the Company’s top enterprise risks on an annual basis. The results of the annual ERM risk assessment are presented to our Board, with additional reporting during the year to the Nominating, Governance and Risk Committee (“NGR Committee”) of the Board.
We currently do not believe that risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected the Company’s business strategy, results of operations, or financial condition. While Insulet maintains cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be fully insured. See Item 1A. “Risk Factors” for a discussion of cybersecurity and other risks which may impact Insulet.
Governance
Our Board oversees management’s processes for identifying and mitigating risks, including from cybersecurity threats, to help align our risk exposure to our strategic objectives. While the Board reviews the Company’s cybersecurity program annually, the
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NGR Committee has primary responsibility for cybersecurity as part of its risk oversight mandate. The NGR Committee is updated regularly on cybersecurity matters from our CISO and members of the CISO’s team. Our CISO briefs the NGR Committee on management’s actions to identify and detect threats and reviews the structure of, and enhancements to, the Company’s defenses as well as management’s progress on its cybersecurity strategic roadmap. The NGR Committee Chair reports to the full Board after each Committee meeting, including information relating to the cybersecurity discussions.
Our Cybersecurity organization, which includes infrastructure security, product security, technology risk management, and security awareness and culture is led by our CISO. Our CISO reports directly to our Chief Technology Officer (“CTO”) and is responsible for developing and implementing our cybersecurity program, including setting the directional cybersecurity strategy, including for the assessment and detection of risks from cybersecurity threats, and continuous improvement plans for the overall cybersecurity program. Our CISO has over a decade of experience leading cybersecurity and technology risk management programs in medical device manufacturing organizations and achieved specific industry certifications, including Certified Information Systems Security Professional.
Our CTO ensures cybersecurity measures are prioritized across research and development, software engineering, and our information technology functions. Our CTO has more than 15 years of experience leading R&D and information technology departments at medical device and technology companies. Our CTO and CISO co-chair a quarterly Technology Risk Committee aimed at providing proper oversight and governance of the cybersecurity program, remediation of identified cybersecurity threats, and execution of our cybersecurity strategy.
Item 2. Properties
We own a 350,000 square foot facility in Acton, MA, which houses both our headquarters and our U.S. manufacturing. We also own a 400,000 square foot facility in Malaysia, which houses manufacturing and office space. As of December 31, 2025, we leased 12 facilities in 7 countries consisting of approximately 289,000 square feet of office, research and development, and warehousing space and other related facilities, primarily in North America and Europe. Additional information regarding our leases is provided in Note 12 to the consolidated financial statements included in Item 8 of this Form 10-K.
Item 3. Legal Proceedings
The information required by this Item is provided under “Legal Proceedings” in Note 16 to the consolidated financial statements included in Item 8 of this Form 10-K and is incorporated herein by reference.
Item 4. Mine Safety Disclosures
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is listed on The NASDAQ Global Market (“NASDAQ”) under the trading symbol PODD.
Holders of Record
As of February 11, 2026, there were 5 registered holders of record of our common stock.
Recent Sales of Unregistered Securities
None.
Stock Performance Graph
The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Health Care Index and the S&P 500 Index for the five-year period beginning on December 31, 2020, and ending on December 31, 2025, assuming reinvestment of all dividends. The historical stock price performance on the graph below is not necessarily indicative of future stock price performance.
2020 2021 2022 2023 2024 2025
Insulet Corporation $ 100 $ 104 $ 115 $ 85 $ 102 $ 111
NASDAQ Health Care $ 100 $ 96 $ 77 $ 82 $ 81 $ 99
S&P 500
$ 100 $ 129 $ 105 $ 133 $ 166 $ 196
The material in this performance graph shall not be deemed to be filed with the SEC and is not incorporated by reference in any filing of Insulet Corporation under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended, whether made on, before, or after the date of this filing and irrespective of any general incorporation language in such filing.
Dividends
We currently intend to retain any earnings to finance research and development and the operation and expansion of our business and do not anticipate paying any cash dividends for the foreseeable future.
Issuer Purchases of Equity Securities
We did not purchase any shares under our $125 million share repurchase program during the fourth quarter 2025.
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Securities Authorized for Issuance Under Equity Compensation Plans
The information required by this Item is provided under Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Item 6. Reserved
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Item 7. 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 in conjunction with our consolidated financial statements and the accompanying notes included in this annual report. The following discussion may contain forward-looking statements that reflect our plans, estimates, and beliefs, which are subject to risks, uncertainties, and assumptions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements.” Columns and rows within tables may not add due to rounding. Amounts have been calculated using actual, non-rounded figures; accordingly, amounts and percentages may not recalculate, and columns and rows within tables may not add due to rounding.
Overview
Our mission is to transform the lives of people with diabetes. We are primarily engaged in the development, manufacture, and sale of our proprietary Omnipod product platform, a continuous insulin delivery system for people with insulin-dependent diabetes. The Omnipod platform primarily includes our most recent generation Omnipod 5 and its predecessor Omnipod DASH, which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing. Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system that integrates with a CGM to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller. It is indicated for type 1 diabetes and, in the United States, for type 2 diabetes for ages 18 and up. The CGM is sold separately by third parties. The Pod currently integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets. Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like PDM with a color touch screen user interface.
Our financial objective is to sustain profitable growth. To achieve this, we launched Omnipod 5 in the United States in 2022, in the United Kingdom and Germany in 2023, and in the Netherlands and France in 2024. In 2025, we launched Omnipod 5 in nine additional countries. We are also working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to new international markets.
During 2025, we completed the randomized portion of our RADIANT study in France, the United Kingdom, and Belgium. The RADIANT study is a randomized controlled trial of Omnipod 5 with Libre 2, designed to provide clinical data to support our pricing and market access initiatives as we roll out Omnipod 5 with multiple sensors across our international markets. In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordable, as no upfront investment is required. We also continue to increase awareness of Omnipod products through our direct-to-consumer advertising programs.
In 2025, we also completed STRIVE, our pivotal study for the next generation hybrid closed loop system, and we finished enrollment for EVOLUTION 2, our safety and feasibility study for a fully closed loop AID system for type 2 diabetes. Additionally, we received 510(k) clearance for enhancements to the Omnipod 5 algorithm to include a lower target glucose set point. We also launched our Omnipod 5 app for iPhone compatible with Dexcom’s G7 CGM sensor in the United States and integrated Omnipod 5 with Dexcom’s G7 CGM sensor in five additional countries and with Abbott’s FreeStyle Libre 2 Plus sensor in Australia. Following the launch of Omnipod 5 in several countries in the Middle East in early 2026, Omnipod 5 is now available in 19 countries. We continue to focus on our product development efforts, including choice of smartphone integration and CGM with Omnipod 5 and enhancing the customer experience through digital product and data capabilities. We are currently working to integrate Omnipod 5 with Abbott’s FreeStyle Libre 3 Plus and developing Omnipod 6, our next generation AID product.
Finally, we continue to take steps to strengthen our global manufacturing capabilities. We began producing product at our new manufacturing plant in Malaysia in 2024 and are already investing in another manufacturing plant in Costa Rica to support our continued growth.
Results of Operations
The discussion of our results of operations for 2023 has been omitted from this Form 10-K but can be found in Item 7. Management’s Discussion and Analysis and Results of Operations in our Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission on February 21, 2025.
Factors Affecting Operating Results
Our Pod is intended to be used continuously for up to three days, after which it may be replaced with a new disposable Pod. As of December 31, 2025, we had more than 600,000 estimated active Omnipod users globally. The unique patented design of the Omnipod allows us to provide Pod therapy at a relatively low or no up-front investment in regions where reimbursement allows
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for it and our pay-as-you-go pricing model reduces the risk to third-party payors. As we grow our customer base, we expect to generate an increasing portion of our revenues through recurring sales of our disposable Pods, which provide recurring revenue.
In August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes. Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our commercial pilot of Omnipod GO, a basal-only Pod for certain individuals with type 2 diabetes, we made a strategic decision to drive growth in the type 2 diabetes market with Omnipod 5. Accordingly, we decided not to move forward with the commercialization of Omnipod GO. As a result, in 2024, we recorded a charge of $13.5 million related to certain inventory components that would not be utilized.
Comparison of the Years Ended December 31, 2025 and December 31, 2024
Revenue
Years Ended December 31,
(in millions)
2025 2024 % Change Currency Impact
Constant Currency (1)
U.S. $ 1,919.8 $ 1,509.3 27.2 % — % 27.2 %
International 754.3 523.4 44.1 % 4.8 % 39.3 %
Total Omnipod Products 2,674.0 2,032.7 31.6 % 1.2 % 30.3 %
Drug Delivery 34.1 38.9 (12.3) % — % (12.3) %
Total $ 2,708.1 $ 2,071.6 30.7 % 1.2 % 29.5 %
(1) Constant currency revenue growth is a non-GAAP financial measure which should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. See “Management’s Use of Non-GAAP Measures.”
Total revenue increased $636.6 million, or 30.7%, to $2,708.1 million in 2025, compared with $2,071.6 million in 2024. Constant currency revenue growth of 29.5% was primarily driven by higher sales volume largely attributable to our growing customer base and, to a lesser extent, higher price.
U.S.
Revenue from the sale of Omnipod products in the U.S. increased $410.5 million, or 27.2%, in 2025 to $1,919.8 million, compared with $1,509.3 million in 2024. This increase primarily resulted from higher sales volume driven by growing our customer base. Revenue from the sale of Omnipod products in the U.S. includes $511.6 million of related party revenue in 2025, compared with $587.8 million in 2024. The $76.2 million decrease primarily resulted from one quarter less of related party sales in the current year, partially offset by growth through the pharmacy channel. Additional information regarding our related party transactions is provided in Note 2 to our consolidated financial statements.
In 2026, we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.
International
Revenue from the sale of Omnipod products in our international markets increased $230.9 million, or 44.1%, in 2025 to $754.3 million, compared with $523.4 million in 2024. Excluding the 4.8% favorable impact of currency exchange, the remaining 39.3% increase in revenue was primarily due to higher volumes from our growing customer base, largely resulting from the prior year launches of Omnipod 5. A higher average selling price for Omnipod 5, compared with Omnipod DASH, also contributed to the revenue increase.
In 2026, we expect higher International revenue due to continued volume growth driven by new customers and higher price resulting from conversions to Omnipod 5.
Drug Delivery
Substantially all of our Drug Delivery revenue consists of sales of pods to Amgen for use in the Neulasta ® Onpro ® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy. Drug Delivery revenue was $34.1 million and $38.9 million in 2025 and 2024, respectively.
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Costs and Expenses
Years Ended December 31,
2025 2024
(in millions)
Amount Percent of Revenue Amount Percent of Revenue
Cost of revenue $ 768.2 28.4 % $ 625.9 30.2 %
Research and development expenses $ 301.1 11.1 % $ 219.6 10.6 %
Selling, general and administrative expenses $ 1,165.0 43.0 % $ 917.2 44.3 %
Cost of Revenue
Cost of revenue for 2025 increased $142.3 million, or 22.7%, to $768.2 million, compared with $625.9 million in 2024. Gross margin was 71.6% in 2025, compared with 69.8% in 2024. The 180 basis points increase in gross margin was primarily driven by improved manufacturing and supply chain efficiencies, a higher average selling price, increased volume and a $13.5 million charge in the prior year related to certain components utilized in OmnipodGO, which we decided not to commercialize.
While we do not expect tariffs to have a significant impact on our gross margin in 2026, should the exemption that is currently in place for certain medical devices be eliminated, tariffs would have a material impact on our results of operations in future years.
Research and Development
Research and development expenses increased $81.5 million, or 37.1%, to $301.1 million for 2025, compared with $219.6 million for 2024. Research and development expenses as a percent of revenue increased to 11.1% in 2025 from 10.6% in 2024. The increase in research and development expense was primarily due to year-over-year headcount additions to support continued investment in our Omnipod and pipeline products, including a fully closed loop AID system for type 2 diabetes, the integration of Libre 3 with Omnipod 5, and Omnipod 6, our next generation AID system. To a lesser extent, the increase was driven by higher consulting costs to support our clinical trials and Omnipod and next generation products.
Selling, General and Administrative
Selling, general and administrative expenses increased $247.8 million, or 27.0%, to $1,165.0 million in 2025, compared with $917.2 million in 2024. This increase was primarily attributable to year-over-year headcount additions to support our business growth, mainly in our commercial and customer experience teams, and incremental advertising expense of $37.1 million. Increased investments in global marketing and training for the sales team to support demand generation also contributed to the increase in selling, general and administrative expenses, although to a lesser extent.
Non-Operating Items
Interest Expense and Income
Interest expense increased $16.7 million to $59.4 million in 2025, compared with $42.7 million in 2024 primarily due to the issuance of 6.5% senior unsecured notes in March 2025 and the renewal of interest rate swaps at higher rates in April 2025. The increase was partially offset by lower interest on our Term Loan B resulting from the refinancing in August 2024 and fees paid to amend our Term Loan B in the prior year, which did not repeat in the current year. Interest income decreased $4.9 million to $34.7 million in 2025, compared with $39.5 million in 2024 primarily driven by lower interest rates.
In 2026, we expect net interest expense to increase to $40 million or more, primarily due to lower interest income.
Loss on Extinguishment of Debt
During 2025, we repurchased $419.9 million million in principal ($417.6 million net of issuance costs) of our Convertible Senior Notes for $541.5 million in cash, which resulted in a $123.9 million loss on extinguishment. Refer to Note 13 to our consolidated financial statements for additional information.
Other Income (Expense), net
Other income, net of $14.3 million for 2025 primarily consists of a $12.5 million gain resulting from the change in fair value of the derivative asset associated with the redemption of our convertible debt discussed in Note 15. Other expense, net of $5.5 million for 2024 consists primarily of a $3.8 million loss related to fair value adjustments associated with a strategic debt investment.
Income Taxes
Our effective tax rate was 27.2% for 2025, compared with a tax benefit of 39.3% for 2024. The increase in our effective tax rate was primarily due to the absence of a valuation allowance against deferred tax assets that existed in the prior year and the loss
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