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What changed in Insulet Corporation's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Insulet Corporation's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+404 added−449 removedSource: 10-K (2026-02-18) vs 10-K (2025-02-21)

Top changes in Insulet Corporation's 2025 10-K

404 paragraphs added · 449 removed · 307 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

101 edited+15 added−39 removed52 unchanged
Biggest changeCertain 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 as to the application of certain key aspects of these laws and regulations as they relate to certain of our arrangements and programs, including those with providers with respect to user training.
Biggest changeSince 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.
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 or 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.
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.
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 physician and their immediate family members.
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.
We are subject to 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.
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.
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. 5 Table of Contents 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.
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. 5 Table of Contents 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.
Omnipod DASH Omnipod DASH features a secure 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 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.
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 wireless Bluetooth communication.
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.
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 Glooko and Diasend in selected regions).
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).
The General Data Protection Regulation (“GDPR”) is a comprehensive update to the data protection regime in the European Economic Area 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.
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.
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; • 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.
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; 8 Table of Contents • 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 to basal insulin, people with insulin-dependent diabetes 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.
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.
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-intensive type 2 diabetes as insulin-dependent diabetes. Diabetes Management Challenges Diabetes is often frustrating and difficult for people to manage.
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.
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.
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.
Individuals with type 1 diabetes require daily insulin therapy to survive. We estimate that approximately 5 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.
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.
International 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 approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.
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.
We believe that these advantages, along with technological advancements, including the use of continuous glucose monitoring technology and automated insulin device (“AID”) algorithms, and increased awareness of insulin pump therapy, will continue to generate demand for insulin pump devices.
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.
Violations of the False Claims Act are subject to the imposition of significant per claim penalties, three times the amount of damages that the federal government sustained and possible exclusion from participation in federal healthcare programs like Medicare and Medicaid.
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.
Even if a clinical trial is completed, the results of our clinical testing 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.
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.
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. Intellectual Property To maintain a competitive advantage, we believe we must develop and preserve the proprietary aspect of our technologies.
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. 7 Table of Contents Intellectual Property To maintain a competitive advantage, we believe we must develop and preserve the proprietary aspect of our technologies.
Because of the breadth of these 11 Table of Contents 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 ” ).
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 ” ).
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.
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 refer to this 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.
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.
We are subject to announced and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of our subcontractors.
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.
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.
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.
In some cases, these state laws apply regardless of the payor, including private payors. We believe that we are in compliance with such laws. 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.
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.
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.
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 percentages of total revenue for customers that represent 10% or more of total revenue was as follows: Years Ended December 31, 2024 2023 2022 Distributor A 28% 28% 19% Distributor B 26% 24% 16% Distributor C 21% 19% 17% Our sales and marketing efforts are focused on customer acquisition and retention to meet the user, clinician, and payor demands for our Omnipod products.
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 purchase some supplies from a single or limited number of sources for reasons of proprietary know-how, quality assurance, cost-effectiveness, or constraints resulting from regulatory requirements.
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.
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 now available in 10 countries.
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.
A clinical trial may be suspended by the FDA or at a specific site by the relevant IRB 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.
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.
Noncompliance can result in significant civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service, and exclusion from the federal healthcare programs. 10 Table of Contents Federal Healthcare Fraud Statutes.
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.
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 by developing online resources and increased our field clinician team to directly train new users.
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 estimate that approximately 40% of the type 1 diabetes population in the United States and 20% of the international type 1 diabetes population use insulin pump therapy. An even smaller portion of the U.S. and international insulin-intensive type 2 diabetes population and the U.S. basal only insulin type 2 population use insulin pump therapy.
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.
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. Our policies mandate compliance with these anti-bribery laws.
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.
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 making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim.
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.
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. Privacy Laws. At least 15 states have enacted various privacy laws of general applicability over the past several years.
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.
Historically, type 2 diabetes has occurred in later adulthood, but its incidence is increasing among the younger population, 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.
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.
In addition, we sell Omnipod products through distribution partners and directly to consumers. For the year ended December 31, 2024, 88% of Omnipod product sales globally were through intermediaries.
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 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. Outside of the European Union, regulatory approval needs to be sought on a country-by-country basis for us to market our products.
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 estimate that approximately 6 million people have insulin-intensive type 2 diabetes in the countries we currently serve and another 3 million people with type 2 diabetes in the United States require only long-acting insulin.
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.
Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , Omnipod DISPLAY ® , OmnipodPromise ® , Omnipod VIEW ® , SmartAdjust TM , PodPals ® , Podder ® , and PodderCentral ® .
Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , OmnipodPromise ® , Omnipod Discover TM, SmartAdjust TM , PodPals ® , Podder ® , and PodderCentral ® .
The design of certain components and sub-assemblies (including, in some instances, the raw materials used to manufacture them) 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 are critical to the design and functionality of our products.
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.
The issued patents and pending patent applications cover, among other things: • the basic architecture of our Omnipod products, including the pump and the Controller/PDM; • the Omnipod drive system; • the Omnipod cannula insertion system; • software, such as algorithms and apps, 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.
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.
For example, collecting, measuring, and reporting 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.
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.
Patents As of December 31, 2024, we had over 750 patents in the United States and certain other countries, with expiration dates ranging from 2025 through 2047 and had over 550 patent applications pending.
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.
These laws include the U.K. Bribery Act and similar antibribery laws in other jurisdictions in which we operate. Such laws generally prohibit U.S.-based companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business to foreign officials, or in the case of the U.K. Bribery Act, to any person.
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.
Insulin pump therapy has been shown to provide numerous advantages relative to MDI therapy. For example, insulin pump therapy eliminates individual insulin injections, delivers insulin more accurately and precisely than injections, often improves HbA1c (a common measure of blood glucose levels) over time, provides greater flexibility with meals, exercise, and daily schedules, and can reduce severe low blood glucose levels.
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.
MDI therapy may also require a separate injection of a long-acting (basal) insulin, to control glucose levels between meals; typically, once or twice per day. By comparison, insulin pump therapy uses only fast-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements.
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.
We have obtained the right to affix the CE Mark to Omnipod 5 and Omnipod DASH under MDR, which allows us to distribute it throughout the European Union and in the United Kingdom.
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.
Additional legislative changes, regulatory changes, and judicial challenges related to the ACA remain possible. 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 .
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 .
With certifications from the Diabetes Technology Society’s “Standard for Wireless Diabetes Device Security” cybersecurity and assurance standard and program as well as from the International Organization for Standardization (“ISO”), Insulet is globally recognized for incorporating the highest standards for cybersecurity, information security, and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.
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.
If we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry, or stakeholder expectations and concerns regarding environmental issues, investors may reconsider their investment in us, and customers and suppliers may choose to limit their business with us, which could have a material adverse effect on our business, operations, or reputation.
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.
Competitive Pay and Benefits Our compensation program is designed to align employee compensation 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 earnings for both short-term and long-term performance.
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.
The federal healthcare Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of any form of remuneration (anything of value) in return for, or to induce: • the referral of an individual; • furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid, or other federal healthcare programs; or • the purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of, any item or service reimbursable under Medicare, Medicaid, or other federal healthcare programs.
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.
Liability under such laws 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.
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.
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.
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. 12 Table of Contents Our success thrives on the various perspectives, thoughts, experiences, and backgrounds within our workforce.
Our business practices could be subject to scrutiny and enforcement under the federal False Claims Act. 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 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.
Our principal office is located at 100 Nagog Park, Acton, Massachusetts, 01720 and our website address is http://www.insulet.com .
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 may be required to incur significant costs to comply with these laws and regulations in the future and complying with these laws may result in a material adverse effect on our business, financial condition, and results of operations. Increasingly, regulators, customers, investors, employees, and other stakeholders are focusing on environmental, social and governance matters and related disclosures.
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.
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 penalties and materially adversely impact our business and financial results.
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.
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. 9 Table of Contents Federal Anti-Kickback and Self-Referral Laws.
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.
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.
We are also aware of the increasing use of GLP-1 products that may delay the progression of type 2 diabetes in obese patients. 6 Table of Contents 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.
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 an investigational device exemption (“IDE”) and obtain IDE approval prior to commencing human clinical trials.
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.
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, clinical trials, manufacture, labeling, and adverse event reporting for medical devices, including the Medical Device Directive (“MDD”) and the MDR, which replaced MDD in 2021.
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.
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.
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. 13 Table of Contents
Raw Materials We use a broad range of raw materials in the assembly and manufacturing of our products. We purchase our raw materials and select components used in the manufacturing of our products from external suppliers.
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.
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.
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.
We have also posted the charters for our Audit Committee, Talent and Compensation Committee and Nominating, Governance and Risk Committee, as well as our Code of Business Conduct and Ethics, under the heading “Corporate Governance” in the Investors section of our website. The information on our website is not incorporated in this report by reference.
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.
In the United States, consumers generally have commercial insurance, Medicare or Medicaid coverage that pays for the product. 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.
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.
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.
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.
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 protect us from reckless or criminal acts committed by our employees or agents.
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.
We have obtained 510(k) clearance for Classic Omnipod, Omnipod DASH, and Omnipod 5 and expect that regulatory clearances or approvals will be needed for some of our future products. 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. 8 Table of Contents Clinical Trials.
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.
Security Paramount to our ability to deliver full compatible smartphone control is our commitment to cybersecurity and information security.
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.
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.
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.
Training and Development Our people are core to our success and the achievement of our business strategy. We are therefore 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.
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.
In addition, the European Union Whistleblower Directive and other applicable law around the world impose specific requirements on companies regarding speak up policies and non-retaliation policies. General Data Protection Regulation.
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 embedded algorithm utilizes these glucose values to predict glucose levels into the future and automatically adjusts insulin dosing intended to improve time-in-range and reduce the occurrence of blood glucose highs and lows. The user can also deliver insulin doses for snacks or meals or to correct high blood glucose through the system.
The embedded algorithm utilizes these glucose values to predict glucose levels into the future and automatically adjusts insulin dosing intended 4 Table of Contents 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.
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 healthcare systems in those countries and provinces.
In all countries where we operate, either Insulet or our partners establish appropriate reimbursement contracts with local healthcare systems.
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.
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. 9 Table of Contents 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.
Since clearance of the first generation of our Omnipod product, we have been subject to FDA inspections of our facilities on multiple occasions. 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.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe expect that the future results of our Drug Delivery product line will face several challenges, including: • our identification of drug delivery opportunities for a modified Pod; • our achievement of satisfactory development and pricing terms with the pharmaceutical companies that sell such drugs; • our development of appropriate modifications to our Omnipod technology to address the needs and parameters required for the respective drug-delivery opportunities; • manufacturing issues relating to the modified Pod; • long lead-times associated with the development, regulatory approvals, and ramp up applicable to the use of modified Pods for the delivery of such drugs; • relatively small number of modified Pods needed to address each drug-delivery opportunity; • uncertainties regarding the market acceptance of such drugs and the modified Pod as an appropriate delivery device; • uncertainties relating to the success of the pharmaceutical companies in marketing and selling such 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; • maintaining appropriate gross margins; and • regulatory requirements and reimbursement rates associated with such drugs.
Biggest changeWe 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.
An interruption, delay, or inability to obtain components, products, and raw materials from our third-party suppliers at acceptable prices 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.
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.
We develop and license from other developers, and deploy, AI tools including Generative AI tools for use in our operations.
We develop, license from other developers, and deploy AI tools, including generative AI tools for use in our operations.
We may in the future seek additional funds from public and 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.
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.
This could result in a material adverse effect on our business, 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.
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.
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 and services, impact the competitive position of our products, or otherwise adversely affect our ability to sell products in the affected countries.
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 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 these products.
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.
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 use and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose.
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.
In addition, future clinical studies or articles regarding our existing products or any competing products may be published that either support a claim, or are perceived to support a claim, that a competitor’s product is clinically more effective or easier to use than our products or that our products are not as effective or easy to use as we claim.
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.
To help improve, market, and sell our Omnipod products, we have sponsored, and expect to continue to sponsor, market studies to assess various aspects of the functionality and relative efficacy of our products. The data obtained from the studies may be unfavorable to our products or may be inadequate to support satisfactory conclusions.
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.
The loss of any of these rights could impair the functionality of our products or prevent us from selling our products without significant development and regulatory activities that may not be completed in time to prevent an interruption in the availability of our products to consumers.
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.
However, the ever-evolving threats mean we must continually evaluate and adapt our systems and processes, and our efforts may not be adequate to safeguard against all data security breaches, misuse of data, or sabotage of our systems.
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.
In addition, well-capitalized biopharmaceutical companies like Vertex Pharmaceuticals, the National Institutes of Health, and other supporters of diabetes research, are continually seeking ways to prevent, cure, or improve the treatment of 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.
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 subject to whistleblower lawsuits under federal and state false claims laws.
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.
We are subject to a variety of laws and regulations relating to privacy and data protection. The introduction of new products or expansion of our activities in certain jurisdictions may subject us to additional laws and regulations.
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.
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; • 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.
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; 20 Table of Contents • 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.
Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could adversely affect our business, financial condition, and 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 rely on third parties, such as contract research organizations, medical institutions, clinical investigators, contract laboratories, and other third parties to conduct some of our clinical trials and pre-clinical investigations.
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.
We are dependent upon third-party suppliers, making us vulnerable to supply problems 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 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.
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 were to gain acceptance by healthcare professionals, people with insulin-dependent diabetes, or third-party payors, we could experience pricing pressure.
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.
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 problems that could unexpectedly compromise information and device security.
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 California laws have served as a model for many subsequently adopted laws in other states like 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.
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.
Our business, like that of most medical device manufacturers, involves the receipt, storage, and transmission of customer information and payment and reimbursement information, as well as 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.
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.
We and our contract manufacturers 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.
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.
Our products are manufactured in three locations: at our manufacturing facility in the United States, at our newly constructed 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.
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.
For example, CCPA 24 Table of Contents 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.
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.
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 26 Table of Contents condition, and results of operations could be materially and adversely affected.
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.
However, if the FDA determines that 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.
However, if the FDA determines that 21 Table of Contents 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.
Government regulation of medical devices is meant to assure 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; • regulatory 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; 22 Table of Contents • post-market studies; and • product import and export.
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.
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 manufacturers’ facilities will pass any future quality system inspection.
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.
While we believe and make every effort 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.
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.
Any future significant compromise or breach of our data security, whether external or internal, or 25 Table of Contents 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.
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.
While we anticipate being able to capitalize on opportunities using AI tools including Generative AI tools, improving efficiencies and creating more personalized experiences, doing so is not without risk. Risks include potential inappropriate disclosure of personal information and confidential information and potential use of inaccurate information contained in Generative AI outputs.
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.
Risks Related to Our Debt Our Credit Agreement imposes restrictions on us that may adversely affect our ability to operate our business.
Risks Related to Debt Our Credit Agreement imposes restrictions on us that may adversely affect our ability to operate or grow our business.
Item 1A. Risk Factors Risks Related to Our Business and Industry We currently rely on sales of our Omnipod product platform to generate nearly all our revenue. We expect to continue to derive nearly all our revenue from our Omnipod product platform.
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.
If we fail to comply with Medicare, Medicaid, fraud and abuse, and other healthcare regulations, we could be subject to substantial penalties and/or be excluded from participation in government programs.
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.
Risks Related to Economic Conditions and Operating Internationally The continuing worldwide macroeconomic and geopolitical uncertainty as well as the impact of global pandemics may adversely affect our business and prospects.
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.
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, as we are currently doing in several cases.
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.
Political or financial instability, currency fluctuations, the outbreak of pandemics such as COVID-19, labor unrest, 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, increase our costs, and/or adversely affect our results of operations.
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.
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. As we expand our sales efforts internationally, we may need to obtain additional foreign approval certifications.
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.
We take precautions to ensure that our third-party contract manufacturer and logistics entity safeguard our assets, including maintaining 20 Table of Contents insurance, enacting health and safety protocols, and storing computer data offsite.
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.
Our agreement with Glooko expires in December 2025. If this agreement is not renewed in the future and we do not develop or contract for an alternative data management system, our business could be materially adversely impacted.
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.
Risks Related to Information Technology, Privacy and Security We are subject to complex and evolving laws and regulations regarding privacy and data protection, many of which are subject to change and uncertain interpretation, which could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.
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.
Our reliance on these third-party suppliers, as well as on our third-party manufacturer, subjects us to other risks that could harm our business, including: • our suppliers may give other customers’ needs higher priority than ours affecting 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 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; • the occurrence of a fire, natural disaster, or other catastrophe, impacting one or more of our suppliers, may affect their ability to deliver products to us in a timely manner; • our suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements, and • our suppliers may fail to comply with environmental, conflict minerals, anti-slavery, or other applicable laws, thus impairing our ability to source 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.
We rely on the proper function, availability, and security of our product and information technology systems; a successful cyber-attack or other breach or disruption of our product or these systems could have a material adverse effect on our business and results of operations.
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.
However, a natural or other disaster, such as a fire or 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 in any particular case.
However, a natural or other disaster, such as a fire or 18 Table of Contents 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.
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 the dedication of our time and capital, could distract management from operating our business and potentially harm our reputation and financial results.
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.
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.
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.
A transition to new suppliers may result in additional costs or delays. We may misjudge the amount of time or resources that will be required to effectively manage any anticipated or unanticipated growth in our business, or we may not be able to manufacture sufficient inventory, or attract, hire, and retain sufficient personnel to meet our needs.
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.
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. 19 Table of Contents Our financial condition or results of operations may be adversely affected by international business risks.
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.
If we cannot scale our business appropriately, maintain control over expenses, or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, we may not be able to deliver our Omnipod products in a timely manner, and our results of operations may be adversely affected.
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.
In addition, such litigation could cause negative publicity, adversely affect prospective users, 18 Table of Contents cause product shipment delays, limit or prohibit us from manufacturing, marketing, or selling our current or future products, and/or require us to 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.
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 we are presented with appropriate opportunities, we may pursue acquisitions or investments in complementary businesses, products, or technologies. For example, in 2022, we acquired one of our suppliers. We may not complete transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the expected benefits of any acquisition or investment.
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, 24 Table of Contents and we may not realize the expected benefits of any acquisition or investment.
Recruiting, training, managing, motivating, and retaining these employees, especially in 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 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 our intermediaries are unwilling or unable to market and sell our products, or if they or our sales force do not perform to our expectations, we could experience delayed or 15 Table of Contents reduced market acceptance and sales of our products, which would adversely affect our business, financial condition, and results of operations.
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.
If our or our contract manufacturers’ facilities fails a quality system inspection or otherwise fails to adhere to QSR requirements, this could delay production of our products and lead to business disruption; failure to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation could result in business disruption; 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 financial condition or results of operations.
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.
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.
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.
We expect that sales of our Omnipod products, which, for Omnipod 5, occur only through the pharmacy channel in the United States and for Omnipod DASH, primarily through the pharmacy channel, will be limited unless a substantial portion of their sales price is 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.
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 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. The price of our common stock may be volatile.
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.
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.
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.
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.
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.
These risks and expenses include: • 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; • difficulties associated with foreign legal systems, including increased costs associated with enforcing contractual obligations in foreign jurisdictions; • adapting to the differing laws and regulations, business and clinical practices, and consumer preferences in international markets; • difficulties in managing international relationships, including any relationships that we establish with foreign partners, distributors, or sales or marketing agents; and • difficulty in collecting accounts receivable and longer collection periods.
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; 17 Table of Contents • 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.
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.
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.
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.
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.
If future clinical trials fail to support the efficacy of our current or future products, our sales may be adversely affected and we may lose an opportunity to secure clinical preference from prescribing clinicians, which may have a material adverse effect on our business, financial condition, and results of operations.
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.
As we continue to expand the number of customers we serve, driven in large part by significant demand for Omnipod 5, we expect to continue to increase our manufacturing capacity, our personnel, and the scope of our sales and marketing efforts.
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.
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.
Significant manufacturing problems could have a material adverse effect on our business, results of operations, financial condition, and cash flows. 19 Table of Contents 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.
While we anticipate entering into additional contracts with other intermediaries and third-party payors, we cannot assure that our efforts will be successful, which could limit the availability of Omnipod products. In addition, these contracts can generally be terminated by the third-party payor without cause.
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.
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.
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.
In addition to promoting, marketing, and selling Omnipod products through our own direct sales force, we also utilize domestic and international intermediaries to distribute our product to users. We need to expand our distribution network to maintain and grow our business and revenue.
In addition to promoting, marketing, and selling Omnipod products through our own direct sales force, we utilize intermediaries to distribute our product.
We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially valuable. Additionally, we may provoke third parties to assert claims against us, and we may not be successful defending against these claims.
We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially valuable.
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 Supply Chain, Operations, and Drug Delivery Our inventory is produced and maintained in a limited number of locations.
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.
Any lawsuits that we initiate could be expensive, take significant time, and divert management’s attention from other business concerns. The outcome of litigation to enforce our intellectual property rights is highly unpredictable. A court could determine that some or all of our asserted intellectual property rights are not infringed or misappropriated, or are invalid, or unenforceable.
Any lawsuits that we initiate could be expensive, take significant time, 16 Table of Contents 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.
Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could have a material adverse effect on our business, financial condition, and results of operations. 16 Table of Contents Healthcare reform laws could adversely affect our revenue and financial condition.
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. 14 Table of Contents If we fail to expand our relationships with intermediaries, our ability to grow our business may be materially and adversely affected.
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.
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.
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.
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.
Failure to fulfill foreign regulatory requirements on a timely basis or at all could adversely affect our ability to grow our business. If we, our contract manufacturer or our component suppliers 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.
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.
These changes or increased costs could negatively impact our business and results of operations in material ways.
These changes or increased costs could materially and adversely affect our business and results of operations.
If demand for our products fluctuates as a result of economic conditions, competition, or otherwise, our ability to attract and retain customers could be harmed. The failure to retain a high percentage of our customers could negatively impact our revenue growth and may have a material adverse effect on our business, financial condition, and results of operations.
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.
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. We may need to raise additional funds in the future, and these funds may not be available on acceptable terms or at all.
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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur Board of Directors (“Board”) oversees management’s processes for identifying and mitigating risks, including cybersecurity risks, to help align our risk exposure to our strategic objectives. While the Board reviews the Company’s cybersecurity program annually, the Nominating, Governance, and Risk Committee (“NGR Committee”) of the Board has primary responsibility for cybersecurity as part of its risk oversight mandate.
Biggest change“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.
Our CISO has over a decade of experience leading cyber-security and technology risk management programs in both healthcare and medical device manufacturing organizations and maintains multiple industry certifications, including Certified Information Systems Security Professional and Certified Information Security Manager. The CTO ensures cyber-security measures are prioritized across research and development, software engineering, and our information technology functions.
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 CISO, reports directly to our Chief Technology Officer (“CTO”) and is responsible for developing and implementing our cybersecurity program, including setting the directional security strategy and continuous improvement plans for the overall security program.
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.
We are intensely focused on protecting the security of our products; our guiding principle of “security and privacy by design” underlies all of our product development. We have a cybersecurity team embedded with our research and development group to deliver on this mission as well as a Product Cybersecurity Risk Management Policy that aligns with FDA guidance.
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. Our Secure Software Development Lifecycle enforces application testing and continuous monitoring to identify security risks. Omnipod 5 is certified by ISO (27001, 27017 and 27799) and the U.K. Cyber Essentials.
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.
These final reports and gap analysis documents are logged into our risk register as appropriate. • Operating Technology (“OT”) Visibility. As a manufacturer of medical devices, OT is a vital component of our business operations. Interconnectedness between OT technology and other business critical information technology 28 Table of Contents infrastructure can create a material cyber risk.
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.
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 Cybersecurity organization, which includes infrastructure security, product security, technology risk management, and security awareness and culture is led by our CISO.
CIRP provides the organizational and operational structure to respond to incidents that may affect the confidentiality, integrity or availability of our information systems. 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.
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.
The NGR Committee is updated on cybersecurity matters from our Chief Information Security Officer (“CISO”) and members of the CISO’s team at least twice annually. The CISO discusses 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.
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.
These quick trainings provide constant reminders to our employees to be vigilant and give them the tools to recognize and protect against cyber threats. We also conduct phishing simulations to test effectiveness of our training program with the aim of reducing the percentage of employees who click on suspicious emails.
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.
Insult deploys segmentation and OT-specific monitoring capabilities to mitigate and monitor this risk. • Vendor Management. Vendors and key partners are subject to Insulet’s Vendor Risk assessment process and subsequently monitored by our threat intelligence capability, which tracks our key vendors and suppliers. • Training and Culture .
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.
Training, awareness, and incorporating security into Insulet’s culture is key to reducing risk around common threats such as phishing. We have an operational information security training program for all employees. In addition to annual trainings, we require and monitor completion of frequent “nanolearning” targeted trainings.
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.
Third-party threat intelligence feeds are leveraged to monitor Insulet’s digital footprint and activity that may cause brand damage. • Insider Risk Detection. We have targeted tools aimed at detecting insider threats and suspicious data movement. • Cloud and Vulnerability Management.
In addition, we participate in a third-party healthcare industry cybersecurity threat intelligence data-sharing organization. 25 Table of Contents • 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 reduce the attack surface by establishing secure defaults, implementing least privilege, and monitoring configurations continuously.
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.
The CTO supports the CISO in chairing a quarterly Technology Risk Committee aimed at providing proper oversight and governance of the cybersecurity program, remediation of identified technology risks, and execution of the cybersecurity strategy. Our processes for assessing, identifying, and managing cybersecurity-related risks is also included within our overall enterprise risk management (ERM) program.
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.
Should a cyber incident occur, we have in place the Insulet Cybersecurity Incident Response Procedure (“CIRP”) and Crisis Management Plan, which are designed to enable us to respond efficiently to any incidents. Pursuant to the CIRP, cybersecurity incidents are reviewed and rated by our CISO and his team.
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.
As part of vulnerability and overall security posture management, we have a focused cross-functional team that meets regularly to address issues identified by security scans and security configuration checks to maintain hygiene of Insulet’s computing devices. • Testing and Audits. Regular penetration testing, incident response tabletop testing, and audits are performed by trusted third-party security consultants.
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.
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Item 1C. Cybersecurity We manage cyber risk on a daily basis, as we face a multitude of threats ranging from ransomware, phishing attacks, business email compromise, and a wide array of other cyber-criminal tactics aimed at impacting our operations and compromising our sensitive information.
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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.
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Our customers, suppliers, subcontractors, and partners face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these entities could materially adversely affect our operations, performance and results of operations. Accordingly, we have invested in resources (people, processes, and technology) aimed at identifying, assessing, and responding to cyber threats.
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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.
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We leverage the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework to better manage and respond to cybersecurity risks in protecting our infrastructure and sensitive data. We have mapped and base-lined our people, processes, and technology in alignment with the categories defined in the NIST industry standard framework: Identify, Protect, Detect, Respond, and Recover.
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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.
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Additionally, Insulet’s information security management system is ISO 27001 and 27701 certified. For the seventh consecutive year, Insulet received re-certification from the ISO, which is the recognized standard for information security management and privacy best practices that adheres to the highest international data security standards.
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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.
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In 2024, we also added ISO certifications specific to Cloud Computing and Health Informatics, which pairs with and supports other applicable medical device and international certification requirements. We regularly assess the threat landscape and take a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, detection, and mitigation.
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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.
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We maintain a cybersecurity risk register, and cybersecurity team leaders hold monthly meetings to discuss and prioritize risks as well as the status of any remediation activity. Key facets of our cybersecurity program include: • 24/7 cyber monitoring.
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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.
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Our security operations center is located in multiple time zones to ensure around-the-clock coverage and timely threat detection and response. • External Threat Landscape Assessment. Our integrated privacy, legal, and security teams are continuously monitoring for any external threat that may impact our operations.
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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.
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Omnipod 5 incorporates authentication, encryption, and cybersecurity protection to ensure only trusted devices and authorized people can access the system. Notwithstanding the extensive approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us.
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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.
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A cybersecurity incident rated at predefined risk levels will be escalated to CTO, the Chief Compliance Officer, and the General Counsel and assessed for materiality and disclosure to the CEO and the Board. Our internal Disclosure Committee will review any planned public disclosures or filings.
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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.
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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.
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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.
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While the Board reviews the Company’s cybersecurity program annually, the 26 Table of Contents 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.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeAs of December 31, 2024, we leased a total of 11 facilities in 6 countries consisting of approximately 297,000 square feet of office, research and development, and warehousing space and other related facilities, primarily in North America, Asia and Europe.
Biggest changeAs 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 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 our new manufacturing facility and office space.
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.
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Additional information regarding our leases is provided in Note 14 to the consolidated financial statements included in Item 8 of this Form 10-K.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe 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.
Biggest changeThe 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.
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 13, 2025, there were 6 registered holders of record of our common stock. Recent Sales of Unregistered Securities None.
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 Composite Index, the NASDAQ Health Care Index, and the S&P 500 Index for the five-year period beginning on December 31, 2019, and ending on December 31, 2024, assuming reinvestment of all dividends.
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.
Issuer Purchases of Equity Securities None. 30 Table of Contents 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.
Issuer Purchases of Equity Securities We did not purchase any shares under our $125 million share repurchase program during the fourth quarter 2025. 28 Table of Contents 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.
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The historical stock price performance on the graph below is not necessarily indicative of future stock price performance. 2019 2020 2021 2022 2023 2024 Insulet Corporation $ 100 $ 149 $ 155 $ 172 $ 127 $ 152 NASDAQ Composite $ 100 $ 144 $ 174 $ 117 $ 167 $ 215 NASDAQ Health Care $ 100 $ 130 $ 125 $ 100 $ 106 $ 105 S&P 500 (1) $ 100 $ 118 $ 152 $ 125 $ 158 $ 197 (1) Our common stock was added to S&P 500 Index in March 2023.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeAdjusted EBITDA The table below presents reconciliations of Adjusted EBITDA, a non-GAAP financial measure, to net income, the most directly comparable financial measure prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”): Years Ended December 31, (in millions) 2024 2023 Net income $ 418.3 $ 206.3 Interest expense, net 3.2 7.6 Income tax expense (118.1) 8.3 Depreciation and amortization 80.8 72.8 Stock-based compensation expense 69.3 48.3 Voluntary medical device corrections (1) — (11.5) Unrealized loss (gain) on investments (2) 3.8 (2.6) Adjusted EBITDA $ 457.3 $ 329.2 (1) Represents net (income) expense resulting from estimated costs associated with the voluntary MDC notices issued in the fourth quarter of 2022 and adjustments to those costs, which is included in cost of revenue.
Biggest changeAdjusted EBITDA The table below presents reconciliations of Adjusted EBITDA, a non-GAAP financial measure, to net income, the most directly comparable financial measure prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”): Years Ended December 31, (in millions) 2025 2024 Net income $ 247.1 $ 418.3 Interest expense, net 24.7 3.2 Income tax expense (benefit) 92.4 (118.1) Depreciation and amortization 90.4 80.8 Stock-based compensation (1) 62.7 69.3 CEO and CFO transition (2) 9.3 — Loss on extinguishment of debt (3) 123.9 — Gain on derivative asset (4) (12.5) — Loss on investments (5) 7.5 3.8 Adjusted EBITDA $ 645.5 $ 457.2 (1) 2025 includes $11.7 million reversal of stock-based compensation expense associated with the departure of the Company’s former Chief Executive Officer and Chief Financial Officer.
Additionally, we have a Term Loan B (“Term Loan”), which matures in 2031, which contains covenants restricting or limiting our ability to incur additional indebtedness, make asset dispositions, create or permit liens, sell, transfer or exchange assets, guarantee certain indebtedness, and make acquisitions and other investments.
Additionally, we have a Term Loan B, which matures in 2031, that contains covenants restricting or limiting our ability to incur additional indebtedness, make asset dispositions, create or permit liens, sell, transfer or exchange assets, guarantee certain indebtedness, and make acquisitions and other investments.
Words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words or expressions are intended to identify these forward-looking statements. Forward-looking statements are only predictions and involve risks, uncertainties, and assumptions.
Words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “would,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “risk,” or “continue” or the negative of these terms or other similar words or expressions are intended to identify these forward-looking statements. Forward-looking statements are only predictions and involve risks, uncertainties, and assumptions.
Accordingly, in 2024, we recorded a tax benefit of $182.5 million from the release of our valuation allowance. As of December 31, 2024, we have a valuation allowance of $23.9 million on certain U.S. state tax credits and state net operating loss carryforwards because it is more likely than not that those deferred tax assets will not be realized.
Accordingly, in 2024, we recorded a tax benefit of $182.5 million from the release of our valuation allowance. As of December 31, 2025, we have a valuation allowance of $30.6 million on certain U.S. state tax credits and state net operating loss carryforwards because it is more likely than not that those deferred tax assets will not be realized.
Certain of these projected interest payments may differ in the future based on changes in market interest rates. Additional information regarding our leases is provided in Note 14 to the consolidated financial statements. (2) Excludes the impact of the interest rate swaps discussed in Note 17 to our consolidated financial statements.
Certain of these projected interest payments may differ in the future based on changes in market interest rates. Additional information regarding our leases is provided in Note 12 to the consolidated financial statements. (2) Excludes the impact of the interest rate swaps discussed in Note 15 to our consolidated financial statements.
Significant judgement is required in determining whether it is probable that sufficient future taxable income will be available against which a deferred tax asset can be utilized.
Income Taxes Significant judgment is required in determining whether it is probable that sufficient future taxable income will be available against which a deferred tax asset can be utilized.
Adjusted EBITDA represents net income plus net interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation expense and other significant transactions or events, such as legal settlements, medical device corrections, gains (losses) on investments, and loss on extinguishment of debt, which affect the period-to-period comparability of our performances, as applicable.
Adjusted EBITDA represents net income plus net interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation expense and other significant transactions or events, such as legal settlements, gains (losses) on 33 Table of Contents investments, and loss on extinguishment of debt, which affect the period-to-period comparability of our performances, as applicable.
The Revolving Credit Facility contains a covenant to maintain a specified leverage ratio when there are amounts of at least 35% of the aggregate Revolving Credit Facility outstanding. It also contains other customary covenants, none of which we consider restrictive to our operations.
At December 31, 2025, no amount was outstanding under the Revolving Credit Facility. The Revolving Credit Facility contains a covenant to maintain a specified leverage ratio when there are amounts of at least 35% of the aggregate Revolving Credit Facility outstanding. It also contains other customary covenants, none of which we consider restrictive to our operations.
Management’s Discussion and Analysis and Results of Operations in our Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission on February 22, 2024. 32 Table of Contents Factors Affecting Operating Results Our Pods are intended to be used continuously for up to three days, after which it may be replaced with a new disposable Pod.
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.
Constant currency revenue growth represents the change in revenue between current and prior year periods using the exchange rate in effect during the applicable prior year period. We present constant currency revenue growth because we believe it provides meaningful information regarding our results on a consistent and comparable basis.
Non-GAAP Financial Measures Management uses the non-GAAP financial measures described below. Constant currency revenue growth represents the change in revenue between current and prior year periods using the exchange rate in effect during the applicable prior year period. We present constant currency revenue growth because we believe it provides meaningful information regarding our results on a consistent and comparable basis.
The Omnipod platform includes: the most recent generation Omnipod 5, and its predecessors Omnipod DASH and Classic Omnipod, all of which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing.
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.
Payment of Taxes for Restricted Stock Net Settlements —Payments for taxes related to net restricted and performance stock unit settlements were $7.6 million and $13.2 million in 2024 and 2023, respectively.
Payment of Taxes for Restricted Stock Net Settlements —Payments for taxes related to net restricted and performance stock unit settlements were $25.9 million and $7.6 million in 2025 and 2024, respectively.
See “Management’s Use of Non-GAAP Measures.” Total revenue increased $374.5 million, or 22.1%, to $2,071.6 million in 2024, compared with $1,697.1 million in 2023. Constant currency revenue growth of 21.9% was primarily driven by higher volume largely attributable to our growing customer base and, to a lesser extent, higher price. U.S.
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.
Additional information regarding our debt is provided in Notes 15 to the consolidated financial statements. 36 Table of Contents Summary of Cash Flows Years Ended December 31, (in millions) 2024 2023 Cash provided by (used in): Operating activities $ 430.3 $ 145.7 Investing activities (146.2) (119.4) Financing activities (28.1) (13.6) Effect of exchange rate changes on cash and cash equivalents (6.8) 1.8 Net increase in cash, cash equivalents, and restricted cash $ 249.2 $ 14.5 Operating Activities Net cash provided by operating activities of $430.3 million in 2024 was primarily attributable to net income, as adjusted for deferred income taxes, depreciation and amortization, stock-based compensation expense, and a $17.0 million working capital outflow.
Additional information regarding our debt and equity is provided in Notes 13 and 17 to the consolidated financial statements. 34 Table of Contents Summary of Cash Flows Years Ended December 31, (in millions) 2025 2024 Cash provided by (used in): Operating activities $ 569.3 $ 430.2 Investing activities (222.7) (146.2) Financing activities (595.3) (28.0) Effect of exchange rate changes on cash and cash equivalents 11.5 (6.8) Net (decrease) increase in cash and cash equivalents $ (237.3) $ 249.2 Operating Activities Net cash provided by operating activities of $569.3 million in 2025 was primarily attributable to net income, as adjusted for loss on extinguishment of debt, depreciation and amortization, stock-based compensation expense, and deferred income taxes, partially offset by a $23.0 million working capital outflow.
Legal Proceedings — In December 2024, a jury found that EOFlow Co., Ltd. (“EOFlow”) and several other defendants misappropriated certain of our trade secrets and awarded us $452 million in damages.
Legal Proceedings — In December 2024, a jury found that EOFlow Co., Ltd. (“EOFlow”) and several other defendants misappropriated certain of our trade secrets and awarded us $452 million in damages. The Court subsequently upheld the jury verdict and further entered a permanent worldwide injunction.
Comparison of the Years Ended December 31, 2024 and December 31, 2023 Revenue Years Ended December 31, (in millions) 2024 2023 % Change Currency Impact Constant Currency (1) U.S. $ 1,509.3 $ 1,251.0 20.6 % — % 20.6 % International 523.4 410.1 27.6 % 0.7 % 26.9 % Total Omnipod Products 2,032.7 1,661.1 22.4 % 0.2 % 22.2 % Drug Delivery 38.9 36.0 8.1 % — % 8.1 % Total $ 2,071.6 $ 1,697.1 22.1 % 0.2 % 21.9 % (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.
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.
Non-GAAP financial measures exclude the effect of items that increase or decrease our reported results of operations; accordingly, we strongly encourage investors to review our consolidated financial statements in their entirety.
In addition, the above definitions may differ from similarly titled measures used by others. Non-GAAP financial measures exclude the effect of items that increase or decrease our reported results of operations; accordingly, we strongly encourage investors to review our consolidated financial statements in their entirety.
The new guidance requires disaggregated disclosure of expenses included in 39 Table of Contents certain expense captions presented in the statements of incomes as well as additional disclosures about selling expenses. We are required to comply with these new disclosure requirements beginning with our annual filing for 2027.
The new guidance requires disaggregated disclosure of expenses included in certain expense captions presented in the statements of incomes as well as additional disclosures about selling expenses. We intend to adopt these new disclosure requirements beginning with our annual filing for 2027, as required. The guidance may be applied prospectively or retrospectively.
Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our Omnipod GO commercial pilot, we made a strategic decision to drive growth in the type 2 diabetes market with Omnipod 5 and, accordingly, decided not to move forward with the commercialization of Omnipod GO.
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.
We present Adjusted EBITDA because management uses it as a supplemental measure in assessing our performance, and we believe that it is helpful to investors and other interested parties as a measure of our 35 Table of Contents comparative performance from period to period.
We present Adjusted EBITDA because management uses it as a supplemental measure in assessing our performance, and we believe that it is helpful to investors and other interested parties as a measure of our comparative performance from period to period. Adjusted EBITDA is a commonly used measure in determining business value and we use it internally to report results.
Proceeds and Repayments from Secured Borrowing —During 2024, we received $45.5 million of cash advances from a third-party to whom we outsource our insurance claim submissions process in a certain country.
Proceeds and Repayments from Secured Borrowing —During 2025, we repaid secured borrowing (net of cash advances) of $12.6 million to a third-party to whom we outsourced our insurance claim submissions process in a certain country. During 2024, we received cash advances (net of repayments) of $10.7 million from this third-party.
International Revenue from the sale of Omnipod products in our international markets increased $113.3 million, or 27.6%, in 2024 to $523.4 million, compared with $410.1 million in 2023.
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.
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 increased $2.9 million, or 8.1%, to $38.9 million in 2024, compared with $36.0 million in 2023.
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.
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. The CGM is sold separately by third parties.
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.
We recently achieved a milestone of 500,000 estimated active global customers using Omnipod products, including 365,000 global customers using Omnipod 5. 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 for it and our pay-as-you-go pricing model reduces the risk to third-party payors.
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 30 Table of Contents for it and our pay-as-you-go pricing model reduces the risk to third-party payors.
GAAP measure) and free cash flow is as follows: Years Ended December 31, (in millions) 2024 2023 Net cash provided by operating activities $ 430.3 $ 145.7 Capital expenditures (124.9) (75.6) Free cash flow $ 305.4 $ 70.1 Commitments and Contingencies Contractual Obligations —The following table summarizes our contractual obligations as of December 31, 2024: (in millions) Short Term Long Term Total Debt obligations $ 83.8 $ 1,309.2 $ 1,393.0 Interest payments (1)(2) 46.9 211.3 258.2 Purchase obligations (3) 282.4 49.2 331.6 Lease obligations (1) 5.4 62.2 67.6 Total contractual obligations $ 418.5 $ 1,631.9 $ 2,050.4 (1) Interest on debt and lease obligations are projected for future periods using the interest rates in effect as of December 31, 2024.
GAAP measure) and free cash flow is as follows: Years Ended December 31, (in millions) 2025 2024 Net cash provided by operating activities $ 569.3 $ 430.2 Capital expenditures (191.6) (124.9) Free cash flow $ 377.7 $ 305.3 Commitments and Contingencies Contractual Obligations —The following table summarizes our contractual obligations as of December 31, 2025: (in millions) Short Term Long Term Total Debt obligations $ 18.4 $ 944.0 $ 962.4 Interest payments (1)(2) 59.6 317.3 376.8 Purchase obligations (3) 353.1 114.1 467.2 Lease obligations (1) 5.8 67.4 73.2 Total contractual obligations $ 436.9 $ 1,442.8 $ 1,879.7 (1) Interest on debt and lease obligations are projected for future periods using the interest rates in effect as of December 31, 2025.
Debt Issuance and Repayments —In 2024, we refinanced our Term Loan, which resulted in net cash proceeds of $130.0 million, net of issuance costs, and the simultaneous repayment of $132.2 million of the Term Loan. Refer to Note 15 for more information regarding this refinancing.
In 2024, we refinanced our Term Loan B, which resulted in cash proceeds of $130.0 million, net of issuance costs, and the simultaneous repayment of $132.2 million of the Term Loan B.
Free cash flow is a non-GAAP measure, which should be considered supplemental to and not a substitute for our reported financial results prepared in accordance with U.S. GAAP. See “Non-GAAP Financial Measures .” A reconciliation between net cash provided by operating activities (the most comparable U.S.
Free cash flow is calculated as net cash provided by operating activities less capital expenditures. Management uses this non-GAAP measure, in addition to U.S. GAAP financial measures, to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP.
Costs and Expenses Years Ended December 31, 2024 2023 (in millions) Amount Percent of Revenue Amount Percent of Revenue Cost of revenue $ 625.9 30.2 % $ 537.2 31.7 % Research and development expenses $ 219.6 10.6 % $ 205.0 12.1 % Selling, general and administrative expenses $ 917.2 44.3 % $ 734.9 43.3 % Cost of Revenue Cost of revenue for 2024 increased $88.7 million, or 16.5%, to $625.9 million, compared with $537.2 million in 2023.
Drug Delivery revenue was $34.1 million and $38.9 million in 2025 and 2024, respectively. 31 Table of Contents 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.
We also continue to expand market access and awareness of Omnipod products through our direct to consumer advertising programs and through growing our presence in the U.S. pharmacy channel, where access to Omnipod 5 and Omnipod DASH is simpler and affordable, as no up-front investment is required.
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.
We also continue to focus on our product development efforts, including AID offerings, such as choice of smartphone integration and CGM, and enhancing the customer experience through digital product and data capabilities. Omnipod 5 integration with Dexcom’s G6 CGM is available in every country where Omnipod 5 is available.
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.
Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements.” Overview Our mission is to improve 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.
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 adoption of ASU 2024-04 is not expected to impact our consolidated financial statements. Forward-Looking Statements This Form 10-K contains forward-looking statements relating to future events or future financial performance that are based on management’s current expectations, estimates, and projections.
The guidance may be applied retrospectively, modified prospectively, or retrospectively. We are currently evaluating the impact of this guidance. Forward-Looking Statements This Form 10-K contains forward-looking statements relating to future events or future financial performance that are based on management’s current expectations, estimates, and projections.
Capitalization The following table contains several key measures to gauge our financial condition and liquidity at the end of each year: As of December 31, (in millions) 2024 2023 Cash and cash equivalents $ 953.4 $ 704.2 Current portion of long-term debt $ 83.8 $ 49.4 Long-term debt, net $ 1,296.1 $ 1,366.4 Total debt, net $ 1,379.9 $ 1,415.8 Total stockholders’ equity $ 1,211.6 $ 732.7 Debt-to-total capital ratio 53 % 66 % Net debt-to-total capital ratio 16 % 33 % Convertible Debt To finance our operations and global expansion, we have periodically issued convertible senior notes, which are convertible into our common stock.
Capitalization The following table contains several key measures to gauge our financial condition and liquidity at the end of each year: As of December 31, (in millions) 2025 2024 Cash and cash equivalents $ 716.1 $ 953.4 Current portion of long-term debt $ 18.4 $ 83.8 Long-term debt, net $ 930.8 $ 1,296.1 Total debt, net $ 949.2 $ 1,379.8 Total stockholders’ equity $ 1,515.2 $ 1,211.6 Debt-to-total capital ratio 39 % 53 % Net debt-to-total capital ratio 9 % 16 % Credit Agreement We have a $500 million senior secured revolving credit facility (the “Revolving Credit Facility”), which expires in 2030.
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.
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.
In 2025, we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.
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.
The working capital outflow was driven by a $32.4 million increase in inventories, a $21.9 million increase in prepaid expenses and other assets, and a $10.4 million increase in accounts receivable, partially offset by a $45.5 million increase in accrued expenses and other liabilities.
The working capital outflow was driven by a $140.2 million increase in accounts receivable and an $81.7 million increase in prepaid expenses and other assets, partially offset by a $160.2 million increase in accrued expenses and other liabilities and a $49.2 million increase in accounts payable.
Additionally, we made $26.4 million and $27.0 million of aggregate principal payments on our equipment financings, Term Loan, and mortgage in 2024 and 2023, respectively. Finance Lease Payments —During 2024, we made $22.7 million in finance lease repayments associated with our Malaysia manufacturing facility, including the amount associated with exercising our option to purchase the property.
Finance Lease Repayments —During 2024, we made $22.7 million in finance lease repayments associated with our Malaysia manufacturing facility, including the amount associated with exercising our option to purchase the property. Proceeds from Option Exercises —Proceeds from option exercises were $19.0 million and $8.2 million in 2025 and 2024, respectively.
Similar to the randomized control trial that we completed in the United States and France for Omnipod 5 with DexCom’s G6 CGM, the objective is to provide data to support our pricing and market access initiatives as we roll out Omnipod 5 with multiple sensors across our international markets.
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.
The increase in accounts receivable was primarily due to an increase in sales driven by our growing customer base. Finally, the increase in accrued expenses and other liabilities was primarily driven by an increase in compensation costs due to headcount additions and an increase in professional consulting fees primarily driven by higher legal costs and direct-to-consumer spending.
The increase in accrued expenses and other liabilities was primarily driven by an increase in accrued compensation driven by higher incentive compensation achievement and headcount additions to support our growing business, and an increase in accrued rebates due to higher sales volume.
GAAP requires management to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. The following accounting policies are based on, among other things, judgments and assumptions made by management that include inherent risks and uncertainties.
The following accounting policies are based on, among other things, judgments and assumptions made by management that include inherent risks and uncertainties.
Revenue from the sale of Omnipod products in the U.S. increased $258.3 million, or 20.6%, in 2024 to $1,509.3 million, compared with $1,251.0 million in 2023. This increase primarily resulted from higher volume through the pharmacy channel driven by growing our customer base, partially offset by a decrease in estimated inventory days-on-hand at distributors and lower conversions to Omnipod 5.
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.
In 2025, we expect higher International Omnipod revenue due to continued volume growth driven by new customers and conversions to Omnipod 5 primarily due to the launch of Omnipod 5 in France and the Netherlands, growth from the earlier launches in Germany and the United Kingdom, and the continued roll out of Omnipod 5 in additional markets.
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.
Following our strategic decision to not move forward with the commercialization of Omnipod GO discussed above, we recorded a charge of $13.5 million related to certain inventory components that we no longer expect to utilize, which is included in our consolidated statement of income for 2024.
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.
Investing Activities Net cash used in investing activities was $146.2 million in 2024, compared with $119.4 million in 2023. Capital Spending —Capital expenditures were $124.9 million and $75.6 million in 2024 and 2023, respectively.
Finally, the increase in accounts payable was driven by the timing of payments and continued growth of our business. Investing Activities Net cash used in investing activities was $222.7 million in 2025, compared with $146.2 million in 2024. Capital Spending —Capital expenditures were $191.6 million and $124.9 million in 2025 and 2024, respectively.
Investments in Developed Software— Investments in developed software were $9.1 million and $8.5 million in 2024 and 2023, respectively, and primarily related to investments in projects to support our cloud-based capabilities. Investments —In 2024 and 2023, we made strategic investments in private companies in the amount of $12.2 million and $7.2 million, respectively.
We expect to fund our capital expenditures using a combination of existing cash and financing. Investments in Developed Software— Investments in developed software were $19.2 million and $9.1 million in 2025 and 2024, respectively, and primarily related to investments in projects to support our cloud-based capabilities.
Results of Operations The discussion of our results of operations for 2022 has been omitted from this Form 10-K but can be found in Item 7.
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.
To achieve this, we launched Omnipod 5 in the United States in 2022 and in the United Kingdom and Germany in June and August 2023, respectively.
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.
Interest income increased $10.9 million to $39.5 million in 2024, compared with $28.6 million in 2023 primarily driven by increased average cash balances and higher interest rates. 34 Table of Contents Other (Expense) Income, net Other expense, net of $5.5 million for 2024 consists primarily of $3.8 million of loss related to fair value adjustments associated with a strategic debt investment.
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.
Accounting Standards Issued and Not Yet Adopted as of December 31, 2024 In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires incremental annual income tax disclosures.
Accounting Standards Issued and Not Yet Adopted as of December 31, 2025 In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive Income—Expenses Disaggregation Disclosures (Subtopic 220-40).
Excluding the 0.7% favorable impact of currency exchange, the remaining 26.9% increase in revenue was primarily due to higher volumes from the launches of Omnipod 5 in the United Kingdom and Germany in the prior year, driven by our growing customer base and the favorable impact of conversions to 33 Table of Contents Omnipod 5.
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.
While we do not expect the Pillar Two Model Rules and related legislation to have a material impact on our consolidated financial statements for 2025, we continue to evaluate their potential impact on future years.
We anticipate additional legislative activity and administrative guidance related to Pillar Two throughout 2026. Based on the legislation enacted as of December 31, 2025, the implementation of Pillar Two did not have a material impact on our consolidated financial statements for 2025. We are continuing to evaluate the potential impact on future periods.
Additionally, we are working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to additional international markets. In August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes.
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.
Proceeds from Shares Issued Under Employee Stock Purchase Plan (“ESPP”) —Proceeds from the issuance of shares under the ESPP were $11.9 million and $10.6 million in 2024 and 2023, respectively.
The $10.8 million increase was primarily driven by more options exercised during the current period and a higher average option exercise price resulting from an increase in our stock price. 35 Table of Contents Proceeds from Shares Issued Under Employee Stock Purchase Plan (“ESPP”) —Proceeds from the issuance of shares under the ESPP were $14.9 million and $11.9 million in 2025 and 2024, respectively.
Management uses this non-GAAP measure, in addition to U.S. GAAP financial measures, to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. In addition, the above definitions may differ from similarly titled measures used by others.
The $72.4 million increase in free cash flow primarily resulted from an increase in operating income, partially offset by an increase in capital expenditures and taxes paid. Free cash flow is a non-GAAP measure, which should be considered supplemental to and not a substitute for our reported financial results prepared in accordance with U.S. GAAP.
Non-Operating Items Interest Expense and Income Interest expense increased $6.5 million to $42.7 million in 2024, compared with $36.2 million in 2023 primarily due to fees paid to amend our Term Loan.
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.
Revenue from the sale of Omnipod products in the U.S. includes $587.8 million of related party revenue in 2024, compared with $473.7 million in 2023. The $114.1 million increase primarily resulted from growth through the pharmacy channel. Additional information regarding our related party transactions is provided in Note 5 to our consolidated financial statements.
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.
The increase in inventories was primarily due to a planned inventory build to satisfy our growing demand and, to a lesser extent, to mitigate supply chain risk. The increase in prepaid expenses and other assets was primarily driven by an increase in prepaid software fees, cloud computing upgrade and implementation costs, prepaid income taxes, and capitalized commissions.
The increase in accounts receivable was primarily due to higher sales driven by our growing customer base. The increase in prepaid expenses and other assets was primarily driven by prepaid payroll, cloud computing costs, prepaid income taxes, and prepaid raw materials.
Management’s estimates are based on the relevant information available at the end of each period. Pharmacy Rebates We exercise significant judgment when we determine variable consideration adjustments.
Management’s estimates are based on the relevant information available at the end of each period. 36 Table of Contents Pharmacy Rebates We generally recognize revenue when control of our products is transferred to customers in an amount that reflects the net consideration we expect to receive.
We expect capital expenditures for 2025 to increase compared with 2024 as we continue to expand and optimize our manufacturing and supply chain operations as well as support our global expansion. We expect to fund our capital expenditures using existing cash.
The $66.7 million increase primarily related to the investment in our third manufacturing plant in Costa Rica and the purchase of additional machinery and equipment for our Malaysia manufacturing facility to support continued business growth. We expect capital expenditures for 2026 to increase compared with 2025 as we continue to expand globally and optimize our manufacturing and supply chain operations.
We expect gross margin to further increase to approximately 70.5% in 2025 primarily due to improved manufacturing efficiencies. Research and Development Research and development expenses increased $14.6 million, or 7.1%, to $219.6 million for 2024, compared with $205.0 million for 2023.
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.
As discussed in Note 2 to our consolidated financial statements, we are subject to rebates on pricing programs with managed care organizations, such as pharmacy benefit managers, governmental and third-party commercial payors, primarily in the United States. Reductions to our revenues for rebates on products sold through our distributors under pharmacy benefits are the most significant component of variable consideration.
Our products are subject to pricing rebates under arrangements with managed care organizations, including pharmacy benefit managers, governmental payors, and third-party commercial payors, primarily in the United States. These rebates represent amounts owed pursuant to contractual agreements or legal requirements after the product is dispensed to a benefit plan participant.
The $5.6 million decrease was primarily driven by a lower fair market value of the restricted and performance stock units (“PSUs”) that vested in 2024 compared to the prior year, partially offset by higher achievement of the PSUs that vested in 2024 (111% achievement), compared to in the prior year (84% achievement).
The $18.3 million increase was primarily driven by more RSUs vesting during the current period due to headcount additions to support the growth of the business and a higher fair market value of the restricted stock units that vested during the period.
Off-Balance Sheet Arrangements Information regarding our letters of credit is provided in Note 18 to the consolidated financial statements. 38 Table of Contents Critical Accounting Policies and Estimates The preparation of our consolidated financial statements in conformity with U.S.
Refer to Note 16 to our consolidated financial statements for additional information regarding this matter. Critical Accounting Policies and Estimates The preparation of our consolidated financial statements in conformity with U.S. GAAP requires management to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses, and related disclosure of contingent assets and liabilities.
Our recent type 2 indication for Omnipod 5, the launch of Omnipod 5 integrations with both Dexcom’s G7 CGM and Libre 2 Plus, and the launch our Omnipod 5 app for iPhone, are expected to contribute to an increase in our customer base.
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.
This increase primarily resulted from an increase in orders from our partner, partially offset by a reimbursement from our partner to cover a portion of our increased production costs in the prior year, which did not repeat in the current year.
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.
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Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like PDM with color touch screen user interface. We have been phasing-out Classic Omnipod as we launch Omnipod 5. Our financial objective is to sustain profitable growth.
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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.
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In June 2024, we launched our full market releases of Omnipod 5 in the Netherlands and France, and most recently, in January 2025, we announced that Omnipod 5 is now available in Italy, Denmark, Finland, Norway, and Sweden.
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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.
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During 2024, we completed participant enrollment in our RADIANT study in France, the United Kingdom, and Belgium, which is our Omnipod 5 with Libre 2 randomized controlled trial.
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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.
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In June 2024, we began our full market release of Omnipod 5 with Dexcom’s G7 CGM in the United States.
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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.
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Similarly, in June 2024 we launched our full market release of Omnipod 5 with Libre 2 Plus for individuals aged two years and older with type 1 diabetes in both the United Kingdom and Netherlands, where we offer sensor of choice (integration with either Abbott’s Libre 2 Plus or Dexcom’s G6 CGM).
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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.
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We also now offer sensor of choice in the United States, Italy, Denmark, Finland, Norway, and Sweden. Additionally, in October 2024, our Omnipod 5 app for iPhone compatible with Dexcom’s G6 CGM became fully available in the United States. Finally, we continue to take steps to strengthen our global manufacturing capabilities.
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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.
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In 2024, we began producing product at our newly constructed manufacturing plant in Malaysia. This plant provides us with increased capacity to satisfy our growing demand, supports our international expansion strategy, and is expected to drive higher gross margins over time.
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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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeApproximately 25% of our revenue was denominated in foreign currencies for the year ended December 31, 2024. As our business in regions outside of the United States continues to increase, we will be increasingly exposed to foreign currency exchange risk related to our foreign operations.
Biggest changeApproximately 28% of our revenue was denominated in foreign currencies for the year ended December 31, 2025. We will be increasingly exposed to foreign currency exchange risk related to our foreign operations as our business in regions outside of the United States increases.
At December 31, 2024, we have intercompany receivables and payables from our foreign subsidiaries that are denominated in their functional currencies, principally the Chinese yuan renminbi. Fluctuations from the beginning to the end of a reporting period result in the revaluation of our foreign currency-denominated intercompany receivables and payables, generating currency translation gains or losses.
At December 31, 2025, we have intercompany receivables and payables from our foreign subsidiaries that are denominated in their functional currencies, principally the Chinese yuan renminbi. Fluctuations from the beginning to the end of a reporting period result in the revaluation of our foreign currency-denominated intercompany receivables and payables, generating currency translation gains or losses.
Fluctuations in the rate of exchange between the United States dollar and foreign currencies, primarily the Euro, British pound and Malaysian ringgit, could affect our financial results, including our revenues, revenue growth rates, gross margins, operating income, and net income as well as assets and liabilities.
Fluctuations in the rate of exchange between the United States dollar and foreign currencies, primarily the Euro, British pound, Malaysian ringgit and Mexican peso, could affect our financial results, including our revenues, revenue growth rates, gross margins, operating income, and net income as well as assets and liabilities.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk Interest Rate Risk Our exposure to changes in interest rates is associated with borrowings under our Revolving Credit Facility and our Term Loan, both of which are variable-rate debt. At December 31, 2024, no amounts were outstanding under our Revolving Credit Facility.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk Interest Rate Risk Our exposure to changes in interest rates is associated with borrowings under our Revolving Credit Facility and our Term Loan B, both of which are variable-rate debt. At December 31, 2025, no amounts were outstanding under our Revolving Credit Facility.
In May 2021, we entered into two interest rate swap agreements to effectively convert $480.0 million of our term loan borrowings from a variable rate to a fixed rate through April 2025. These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges.
In April 2025, we entered into interest rate swap agreements to effectively convert $460.0 million of our Term Loan B from a variable rate to a fixed rate. These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges.
Net realized and unrealized gains (losses) from foreign currency transactions are included in other (expense) income, net in the consolidated statements of income and amounted to a loss of $2.3 million for the year ended December 31, 2024. 40 Table of Contents
Net realized and unrealized gains (losses) from foreign currency transactions are included in other income (expense), net in the consolidated statements of income and amounted to a gain of $1.8 million for the year ended December 31, 2025. 38 Table of Contents
The Capped Calls have an upper protection price of $335.90 per share and cover 3.5 million shares of common stock. Foreign Currency Exchange Risk Foreign currency risk arises from our investments in subsidiaries owned and operated in countries other than the United States. Such risk is also a result of transactions with customers in those countries.
A 100 basis point increase or decrease in interest rates as of December 31, 2025 would have an insignificant impact on our annual earnings. Foreign Currency Exchange Risk Foreign currency risk arises from our investments in subsidiaries owned and operated in countries other than the United States. Such risk is also a result of transactions with customers in those countries.
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A 100 basis point increase or decrease in interest rates as of December 31, 2024 would have an insignificant impact on our annual earnings.
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Market Price Sensitive Instruments As of December 31, 2024, we had outstanding debt related to our Convertible Senior Notes recorded on our consolidated balance sheet of $794.9 million, net of unamortized discount and issuance costs totaling $5.1 million.
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Changes in the fair value of our outstanding debt, which could be impacted by changes in interest rates, are not recorded in these consolidated financial statements as the debt is accounted for at cost less unamortized discount and issuance costs.
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The fair value of the Convertible Senior Notes, which was $1,018.8 million as of December 31, 2024, is also impacted by changes in our stock price. In order to reduce potential equity dilution, in connection with the issuance of the Convertible Senior Notes, we purchased Capped Calls.
Removed
We expect the Capped Calls to reduce the potential dilution to our common stock (or, in the event the conversion is settled in cash, to provide a source of cash to settle a portion of our cash payment obligation) if at the time of conversion our stock price exceeds the conversion price under the Convertible Senior Notes.