What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-02-21 compared with 2024-02-23 · 121 added, 124 removed, 296 unchanged (45% of the section changed)

1 unchanged sentence

The Omnipod platform includes:

the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), the Omnipod Insulin Management System (“Classic Omnipod”) and our latest innovation, Omnipod GO TM , which received U.S.

Food and Drug Administration (“FDA”) clearance in 2023.

the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), and the Omnipod Insulin Management System (“Classic Omnipod”).

We also produce pods for Amgen for use in the Neulasta ® Onpro ® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.

9 unchanged sentences

• Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin.

It is frequently diagnosed during childhood or adolescence.

It is diagnosed throughout the age spectrum, with over half of newly diagnosed cases occurring in adulthood.

Individuals with type 1 diabetes require daily insulin therapy to survive.

We estimate that approximately five million people have type 1 diabetes in the countries we currently serve.

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.

2 unchanged sentences

As their diabetes advances, some individuals progress to multiple drug therapies, which often include insulin therapy.

People with type 2 diabetes who take insulin either require intensive insulin therapy (typically multiple injections of insulin per day) or basal insulin (typically a single injection daily or weekly).

We estimate that approximately six million people have insulin-intensive type 2 diabetes in the countries we currently serve and another three million people with type 2 diabetes require only long-acting insulin in the United States.

We estimate that approximately 40% of the type 1 diabetes population in the United States and even less of the international type 1 diabetes population use insulin pump therapy.

People with type 2 diabetes who take insulin either require intensive insulin therapy (typically multiple injections of insulin per day) or basal (long-acting) insulin (typically a single injection daily or weekly).

We estimate that approximately 6 million people have insulin-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 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 use insulin pump therapy.

and international insulin-intensive type 2 diabetes population and the U.S.

basal only insulin type 2 population use insulin pump therapy.

We believe these factors present a significant available market for our Omnipod platform globally.

9 unchanged sentences

People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, for background metabolic needs.

In addition to basal insulin, people with insulin-dependent diabetes 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 require supplemental insulin, known as bolus insulin, to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by other physiological reasons.

There are two primary types of insulin therapy practiced today:

14 unchanged sentences

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 GO

Omnipod 5, which builds on our Omnipod DASH platform, described below, was cleared by the FDA in January 2022.

Our limited market release of Omnipod 5 in the United States commenced the following month, and in August 2022 we launched our U.S.

full market release.

In September 2022, we received CE Mark approval for Omnipod 5 under the European Union Medical Device Regulation (“MDR”) and in 2023, we launched Omnipod 5 in the United Kingdom and Germany.

Omnipod 5 Omnipod DASH

In 2022, we received U.S.

Food and Drug Administration (“FDA”) clearance and CE Mark approval under the European Union Medical Device Regulation (“MDR”) for Omnipod 5, which builds on our Omnipod DASH platform.

Omnipod 5 is now available in 10 countries.

Additionally, in August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes (ages 18 years and older) in the United States.

Omnipod 5 includes a proprietary AID algorithm embedded in the Pod.

2 unchanged sentences

The user can also deliver insulin doses for snacks or meals or to correct high blood glucose through the system.

The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control.

In addition, in October 2023, we received FDA clearance for our Omnipod 5 App for iPhone, which allows for control using a compatible iOS smartphone.

We expect to launch the iOS app in 2024.

The Omnipod 5 Controller and the Omnipod 5 Android and iOS apps use cloud-based technology to wirelessly upload data using a built-in SIM card for cellular connectivity or from a secure Wi-Fi

connection if established.

The Pod currently integrates with Dexcom, Inc.’s G6 CGM and we recently launched a limited market release with Dexcom’s G7 CGM.

Additionally, we plan to launch Omnipod 5 with Abbott Diabetes Care, Inc.’s FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in certain international markets in 2024.

The Pod can be controlled by an Insulet-provided

handheld device or a user-downloaded Android app or, in the US, the iOS app, with full smartphone compatibility.

The Omnipod 5 Controller and the Android and iOS apps use cloud-based technology to upload data wirelessly via a built-in SIM card or secure Wi-Fi.

The Pod currently integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets as depicted under Markets and Distribution Methods .

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.

10 unchanged sentences

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 in the U.S.

and no longer guarantee the availability of its supplies.

Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours.

Omnipod GO has been cleared by the FDA for use by people with type 2 diabetes age 18 and older who would typically take daily injections of long-lasting insulin.

The newest addition to the Omnipod brand features a tubeless and waterproof Pod (with an IP28 rating for up to 25 feet for 60 minutes) which is offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod.

Omnipod GO has been cleared for use with the following U-100 insulins:

NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.

The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections.

As a patient progresses to requiring additional insulin, including basal and bolus, the transition from Omnipod GO to another Omnipod product will be a natural progression.

We developed Omnipod GO with convenience in mind for both the primary care physician and the user, including with respect to prescribing, getting started, training and using the product.

We are currently conducting a pilot program for Omnipod GO in the United States.

Accordingly, we are phasing out our Classic Omnipod product.

Data Management

3 unchanged sentences

Paramount to our ability to deliver full compatible smartphone control is our commitment to cybersecurity and information security.

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 (“IOS”), 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 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.

“Cybersecurity” for additional information.

Third-Party Reimbursement

In the United States, entities to whom our products are sold (including wholesalers, private healthcare organizations, healthcare facilities, mail order pharmacies, independent retailers, and consumers), and the Company in some cases, seek reimbursement from health insurance companies and/or government administrative payors.

In the United States, we sell our products primarily through wholesalers and, to a lesser extent to healthcare organizations, pharmacies, and consumers.

In some cases, we seek reimbursement from government administrative payors and/or health insurance companies.

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 U.S.

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.

3 unchanged sentences

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

We sell Omnipod products directly to consumers, through distribution partners and in the U.S., also through the pharmacy channel.

Australia Cyprus Greece Netherlands*

Austria Denmark*

Iceland Norway*

Belgium Finland*

Israel Qatar United Arab Emirates

Canada France*

Saudi Arabia United Kingdom*

Croatia Germany*

Kuwait Sweden*

United States*

* Represents country in which Omnipod 5 is available

We sell Omnipod products to wholesalers that supply the pharmacy channel in the United States.

In addition, we sell Omnipod products through distribution partners and directly to consumers.

For the year ended December 31, 2024, 88% of Omnipod product sales globally were through intermediaries.

5 unchanged sentences

Distributor C 21% 19% 17%

* Represents less than 10% of revenue for the period.

Our sales and marketing efforts are focused on customer acquisition and retention to meet the user, clinician, and payor demands for our Omnipod products.

6 unchanged sentences

We have streamlined and standardized our training by developing online resources and increased our field clinician team to directly train new users.

We created an online training program for Omnipod customers transitioning to Omnipod DASH or Omnipod 5.

We created an online training program for Omnipod customers transitioning to Omnipod 5 or Omnipod DASH.

In addition, our virtual training allows us to onboard new Omnipod customers transitioning from MDI in a cost-effective manner.

Our distributors and intermediaries have also implemented virtual training programs.

Our distributors have also implemented virtual training programs.

Customer Support

3 unchanged sentences

Our Omnipod platform competes for consumers in the insulin delivery market.

Because most new Omnipod users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we primarily

compete with companies that provide products and supplies for MDI therapy.

We also compete with companies in the insulin pump market, which today consists of tubed pump companies, including Medtronic MiniMed, a division of Medtronic public limited company (“Medtronic”), and Tandem Diabetes Care Inc.

Medtronic historically has held the majority share of the tubed insulin pump market.

Because most new Omnipod users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we primarily compete with companies that provide products and supplies for MDI therapy.

We also compete with companies in the insulin pump market, which today consists of tubed pump companies, primarily Medtronic MiniMed, a division of Medtronic public limited company (“Medtronic”) and Tandem Diabetes Care Inc.

The competitive landscape in our industry continues to undergo significant change.

In addition to the established insulin pump competitors, several companies are working to develop and market new insulin pumps and smart pens.

In addition to the established insulin pump competitors, several companies are

working to develop and market new insulin pumps and smart pens.

These companies are at various stages of development and the number of such companies often changes as they enter or exit the market.

1 unchanged sentence

Our innovation programs are designed to drive:

• simplicity of user interaction with our systems;

• improved outcomes through algorithm advancements;

• 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;

• user choice of sensor and smartphone integrations.

In addition, our research and development efforts are primarily focused on making improvements to Omnipod 5, including adding features and functionality that will deliver increased economic value and convenience to users.

In October 2023, we received FDA clearance for an iOS app that will enable control of Omnipod 5 Pods using an iPhone and plan to launch a limited market release in the U.S.

Further, we recently launched a limited market release for Omnipod 5 integration with Dexcom’s G7 CGM in the United States.

We also recently received CE mark approval under the MDR for the added compatibility of Libre 2 Plus with Omnipod 5 for individuals aged two years and older with type 1 diabetes and expect to launch a limited market release of Omnipod 5 with Libre 2 Plus in the U.K.

and the Netherlands in 2024.

We also continue to advance work to improve the Omnipod 5 algorithm and develop next-generation automated insulin delivery products.

In 2023, we began our EVOLUTION feasibility trial in New Zealand to test potential enhancements to the Omnipod 5 algorithm in order to further drive simplicity of use.

We have completed the first round of study, which included testing the system with both type 1 and type 2 users and are in the process of analyzing the data and making modifications for the next round of study.

In December 2023, we completed enrollment in our pivotal trial for Omnipod 5 with the goal of expanding its indication to individuals with type 2 diabetes.

We expect to complete the trial and submit our 510(k) application to the FDA by the end of 2024.

Further, in April 2023, we received FDA clearance for Omnipod GO, a basal-only Pod for individuals with type 2 diabetes.

Many of our research and development efforts are focused on making improvements to Omnipod 5, including adding features and functionality that will deliver increased economic value and convenience to users.

Advances in innovation in 2024 include the following:

• received FDA clearance for an expanded indication of Omnipod 5 for type 2 diabetes for people aged 18 years and older in the United States;

• launched iOS app with Dexcom’s G6 CGM in the United States;

• launched Omnipod 5 integration with Dexcom’s G7 CGM in the United States;

• launched Omnipod 5 integration with Dexcom’s G6 CGM in France;

• received CE mark approval under the MDR for the added compatibility of both Dexcom’s G7 CGM and Libre 2 Plus with Omnipod 5 for individuals aged two years and older with type 1 diabetes;

• launched Omnipod 5 integration with Libre 2 Plus in the United States, United Kingdom.

and Netherlands.

We also continue to advance work to improve the Omnipod 5 algorithm and develop next-generation AID products.

In 2024, we completed the first round of our EVOLUTION feasibility trial in New Zealand to test potential enhancements to the Omnipod 5 algorithm in order to further drive simplicity of use.

The study included testing the system with both type 1 and type 2 users.

We are in the process of analyzing the data and making modifications for the next round of study.

Manufacturing and Quality Assurance

In order to manufacture sufficient volumes of our Pods at high quality while still achieving a cost-effective per unit production price, we have designed our Pods to be manufactured through automation.

In 2019, we began producing Pods at our highly automated manufacturing facility in Acton, Massachusetts to increase supply redundancy and add capacity closer to our North American customer base to support the growth of our business.

We produce our products at our highly automated manufacturing facility in Acton, Massachusetts and, beginning in June 2024, also at our new highly automated manufacturing plant in Malaysia, which we constructed to support our international expansion strategy and further ensure product supply.

We also produce our devices on manufacturing lines at a facility in China operated by a contract manufacturer.

This contract manufacturing agreement expires in October 2025 and is subject to automatic renewal, unless canceled by either party under the terms of the contract.

In December 2023, we completed construction of our new manufacturing plant in Malaysia to support our international expansion strategy and further ensure product supply.

We expect to begin production at this facility in 2024.

We also continue to invest in supply chain efficiencies, including automation improvements at our suppliers and contract manufacturer.

7 unchanged sentences

These sole-sourced components are critical to the design and functionality of our products.

In the case of sole sourced parts, we manage risk

through holding inventory in-house and at the supplier to ensure continuity of supply and lower risk of disruption.

In the case of sole-sourced parts, we manage risk through holding inventory in-house and at the supplier to ensure continuity of supply and lower risk of disruption.

We purchase many of our components and sub-assemblies from manufacturers with whom we are at least dual-sourced.

2 unchanged sentences

We utilize outside vendors for the supply of components, sub-assemblies, and various services used in the manufacture of our products.

Our outside vendors produce the components to our specifications, and they are audited periodically by our Quality Assurance Department to confirm conformity with the specifications, policies, and procedures for our products.

Our Quality Assurance Department also inspects and tests our products at various steps in the manufacturing cycle to facilitate compliance with our specifications.

Our outside vendors produce the components to our specifications, and they are audited periodically by our Quality team to confirm conformity with the specifications, policies, and procedures for our products.

Our Quality team also inspects and tests our products at various steps in the manufacturing cycle to facilitate compliance with our specifications.

We have received our ISO, European Union MDR, and Medical Device Single Audit Program certifications for our Quality Management System from BSI Group, an accredited Notified Body for CE Marking.

7 unchanged sentences

Despite measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or obtain and use information that we regard as proprietary.

As of December 31, 2023, we had over 700 patents in the United States and in certain other countries, with expiration dates ranging from 2024 through 2043 and had over 500 patent applications pending.

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.

The issued patents and pending patent applications cover, among other things:

• the basic architecture of our Omnipod products, including the pump and the PDM/Controller;

• the basic architecture of our Omnipod products, including the pump and the Controller/PDM;

• the Omnipod drive system;

3 unchanged sentences

We have registered various trademarks associated with our business with the United States Patent and Trademark Office on the Principal Register and in other appropriate jurisdictions.

Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , Omnipod GO TM , Omnipod DISPLAY ® , Omnipod VIEW ® , SmartAdjust TM , Pod Pals ® , Podder ® , and PodderCentral ® .

Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , Omnipod DISPLAY ® , OmnipodPromise ® , Omnipod VIEW ® , SmartAdjust TM , PodPals ® , Podder ® , and PodderCentral ® .

Government Regulation

5 unchanged sentences

Both the 510(k) clearance and PMA processes can be expensive and lengthy and entail significant user fees.

We have obtained 510(k) clearance for Classic Omnipod, Omnipod DASH, Omnipod 5, and Omnipod GO and expect that regulatory clearances or approvals will be needed

for some of our future products.

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.

5 unchanged sentences

If the product is deemed a “non-significant risk” device, IDE approval from the FDA would not be required, but the clinical trial would need to meet other requirements including IRB approval.

Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy.

Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and privacy.

A clinical trial may be suspended by the FDA or at a specific site by the relevant 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.

6 unchanged sentences

• 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 a 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.

• corrections and product recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce the risk to health posed by the device or to remedy a violation of the federal Food, Drug, and Cosmetic Act that may present a risk to health.

In addition, the FDA may order a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death;

7 unchanged sentences

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 addition, several states require that durable medical equipment (“DME”) providers be licensed in order to sell products in that state.

Certain of these states require, among other things, that DME providers maintain an in-state location.

We are also subject to certain state laws regarding professional licensure.

15 unchanged sentences

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.

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,” including durable medical equipment, in which the physician has an ownership or investment interest or with which the physician has entered into a compensation arrangement.

Federal law also includes a provision commonly known as the “Stark Law,” which prohibits a physician from referring Medicare or Medicaid patients to an entity for the furnishing of certain “designated health services,” in which the physician has an ownership or investment interest or with which the physician has entered into a compensation arrangement.

Violation of the Stark Law could result in denial of payment, disgorgement of reimbursements received for items and services referred by a physician with a noncompliant arrangement, civil damages and penalties, and exclusion from Medicare, Medicaid, or other governmental programs.

10 unchanged sentences

Civil Monetary Penalties Law.

know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.

We are subject to the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.

Noncompliance can result in significant civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service, and exclusion from the federal healthcare programs.

Federal Healthcare Fraud Statutes.

We are also subject to a 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 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.

Violations of these statutes can result in significant civil, criminal, and administrative penalties, fines, damages, and exclusion from federal healthcare programs.

12 unchanged sentences

At least 15 states have enacted various privacy laws of general applicability over the past several years.

For example, the California Consumer Privacy Act (“CCPA”) is a consumer privacy law, which provides certain privacy rights and consumer protection for residents of the state of California.

For example, the California Consumer Privacy Act (“CCPA”) and California Privacy Rights Act (“CPRA”) are consumer privacy laws that provide certain privacy rights and consumer protection for residents of the state of California.

These consumer rights include the right to know what personal information is collected, the right to know whether the data is sold or disclosed and to whom, the right to request a company to the delete personal information collected, the right to opt-out of the sale of personal information and the right to non-discrimination in terms of price or service when a consumer exercises a privacy right.

The California Privacy Rights Act (“CPRA”) amends and expands the CCPA with respect to personal data collected beginning in January 2022.

CPRA enforcement is scheduled to begin in March of 2024.

If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance.

Virginia and Colorado have enacted similar laws.

The Consumer Data Protection Act in Virginia and the Colorado Privacy Act both became effective in 2023.

In addition, general privacy legislation has been filed in Congress, but the final form of the legislation and when it might be enacted is difficult to predict.

The California laws have served as a model for similar laws in other states like the Consumer Data Protection Act in Virginia and the Colorado Privacy Act.

In addition, general privacy legislation has been filed in Congress in recent sessions, but the final form of the legislation and when it might be enacted is difficult to predict.

Patient Protection and Affordable Care Act .

9 unchanged sentences

Certain states’ laws require additional reporting of payments and transfers of value to healthcare providers.

Since these laws and regulations continue to evolve, we lack definitive guidance 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.

We cannot predict the final form of these regulations or the effect their application will have on us.

1 unchanged sentence

Ensuring that our business arrangements and interactions with healthcare professionals, third‑party payors, customers, and others comply with applicable healthcare laws and regulations requires substantial resources.

Because of the breadth of these laws and the narrowness of the exceptions or safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of these laws.

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.

Foreign Corrupt Practices Act ( “ FCPA ” ).

We are subject to FCPA in the U.S.

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.

3 unchanged sentences

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.

Artificial Intelligence ( “ AI ” ).

Governments around the world have begun to regulate AI, including Generative AI.

The EU AI Act was enacted in August 2024, with provisions taking effect over time, through August 2026.

states are also starting to legislate in this area, as are other countries.

Federal regulation in the United States is in flux at this time, given the recent change in administrations.

To the extent we develop or deploy AI systems in our business operations or in our products, we will be subject to AI regulations governing AI systems.

We are engaged in regular reviews of development and licensing of software used in the business for compliance with relevant AI regulations.

Guidance from EU regulators is starting to be published and we will continue to track developments in this area and adjust operations accordingly.

In addition, we are subject to numerous federal, state, foreign, and local laws relating to safe working conditions, manufacturing practices, and environmental protection.

We may be required to incur significant costs to comply with these laws and regulations in the future 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.

These changing rules, regulations, and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent meeting such regulations and expectations and complying with disclosure requirements.

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.

In addition, a number of our customers who are payors or distributors have adopted, or may adopt, procurement policies that include environmental provisions that their suppliers or manufacturers must comply with.

If we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry, or stakeholder expectations 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.

International Regulations

4 unchanged sentences

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 May 2021.

Devices that comply with the requirements of the MDD will be entitled to bear the CE conformity marking and, accordingly, can be commercially distributed until May 2024, at which time devices must comply with the MDR, unless certain requirements are met that would allow for an extension until December 2027.

Certain devices that comply with the requirements of the MDD can be commercially distributed until December 2027 if certain requirements are met.

The method of assessing conformity with the applicable directive varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body”.

2 unchanged sentences

Outside of the European Union, regulatory approval needs to be sought on a country-by-country basis for us to market our products.

We have obtained the right to affix the CE Mark to Classic Omnipod and Omnipod DASH under the MDD.

We can continue to sell Classic Omnipod through 2027 under MDD in the European Union and in other countries that recognize the CE Mark and are awaiting certification under MDR for Omnipod DASH.

We have obtained the right to affix the CE Mark to Omnipod 5 under MDR, which allows us to distribute it throughout the European Union and in the United Kingdom.

In addition to these countries, Omnipod DASH can be marketed in the Gulf Cooperation Council Countries and in Australia.

We also have Health Canada approval to sell Classic Omnipod and Omnipod DASH in Canada.

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 to Classic Omnipod under the MDD and can continue to sell Classic Omnipod through 2027 in the European Union and in other countries that recognize the CE Mark.

A range of anti-bribery and anti-corruption laws, as well as industry specific laws and codes of conduct, apply to the medical device industry and interactions with government officials and entities and healthcare professionals.

3 unchanged sentences

Bribery Act, to any person.

In addition, the European Union Whistleblower Directive (effective in late 2023) and other applicable law around the world impose specific requirements on companies regarding speak up policies and non-retaliation policies.

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.

6 unchanged sentences

We strive to attract and retain the best talent with competitive compensation and benefits, opportunities for growth and development, and a culture that emphasizes fair and equitable treatment.

As of December 31, 2023, we had approximately 3,000 full-time employees, representing an 18% increase over the prior year.

As of December 31, 2024, we had approximately 3,900 full-time employees, representing a 29% increase over the prior year.

Approximately 70% of our employees are located in the United States and the remainder are located in 15 other countries.

In 2024, we defined and shared our Ways of Working, the key behaviors that we believe are most important to our success and to creating an exceptional employee experience.

Additionally, in 2024, we launched our Insulet for Good program, which enables employees globally to engage in volunteerism and corporate philanthropy in ways aligned with our corporate strategic priorities.

To assess employee retention and engagement and identify potential opportunities for improvement, we conduct periodic ‘Your Voice’ employee pulse surveys and take timely action to address key areas of employee concern.

3 unchanged sentences

We also publish a monthly global employee newsletter, which includes a timely collection of high-level developments and local highlights from across our organization and utilize a social networking tool to ensure our global employees are engaged, motivated, and collaborating with one another.

Diversity, Equity, and Inclusion (“DEI”)

Our success thrives on the diversity of perspective, thought, experience, and background within our workforce.

We are committed to creating a diverse and inclusive global culture that reflects the diversity of the customers we serve and creates an environment where all employees feel welcomed, respected, and valued.

We are committed to creating a global culture that reflects the diversity of the customers we serve and creates an environment where all employees feel welcomed, respected, and valued.

Accordingly, we are committed to providing equal opportunity in all aspects of our Company culture and workplace.

In 2023, we continued to develop a comprehensive, multi-year diversity and social impact strategy that outlines how to implement our greatest opportunities for impact, in alignment with the needs of our stakeholders and diversity maturity model.

Our DEI activities focus on four main areas—Attraction, Talent Development, Culture, and External Engagement—which reflect our commitment to integrating DEI within our business processes.

In 2023, we continued to embed diversity more formally into our talent acquisition process to attract a diverse pool of candidates.

In addition, we continue to provide Conscious Inclusion and Inclusive Hiring diversity training to people managers and employees.

Our Employee Resource Groups (“ERGs”) serve as a source of inclusion across the following nine categories:

African Descent, Asian and Pacific Islander, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, Young Professionals, and Jewish Heritage.

These ERGs support the acquisition of diverse talent and are sponsored by senior leaders across our organization.

Our voluntary employee-led Employee Resource Groups (“ERGs”) are a thriving part of Insulet’s community, driving inclusion across the following categories:

African Descent, Asian and Pacific Islander, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, Young Professionals, Jewish Heritage, and our newly created People with Diabetes.

These ERGs support the attraction, engagement, development, and retention of our people.

Training and Development

We are committed to fostering an environment in which our employees continuously learn and develop.

We offer both leadership and professional skills development programs.

All employees who join Insulet undergo a robust onboarding program called RITE Start that introduces our core values of respect, integrity, teamwork, and excellence, and educates new employees about diabetes, our Omnipod products, our business strategy, our culture, and our mission, which is to improve the lives of people with diabetes.

In 2022, we launched our ‘Ignite Your Growth’ career development program to employees across the globe and in 2023 we launched our ‘Ignite Your Leadership’ training program to people managers to support the growth and development of our future leaders and build their capabilities.

In addition, we launched LinkedIn Learning to all employees globally providing everyone access to virtual and online learning programs on demand to support their career growth and development.

We also offer training for new managers, resources for our experienced leaders, intensive Customer Care New Hire Training, and Sales New Hire Training.

In addition, employees have access to monthly learning programs and virtual and online learning programs.

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.

All employees who join Insulet undergo a robust onboarding program called RITE Start that introduces our core values and educates new employees about diabetes, Omnipod products, our business strategy, Insulet's culture and Ways of Working, and our mission, which is to improve the lives of people with diabetes and enable them to enjoy simplicity, freedom, and healthier lives through innovative technology.

All employees participate in our flagship ‘Ignite Your Growth’ career development program and as a result, establish an Individual

Development Plan, which is reviewed and updated regularly with their manager.

We also offer LinkedIn Learning to all employees, providing access to virtual and online learning programs on demand to enable them to continuously build their skills and capabilities to support our current and future business needs.

Additionally, we offer professional certification course reimbursement of up to $3,000 annually and tuition reimbursement of up to $5,250 annually for courses taken in pursuit of an undergraduate degree and up to $10,000 annually for courses taken in pursuit of a graduate degree.

Further, managers participate in our ‘Ignite Your Leadership’ development program to support the growth and development of our future leaders and build their capabilities.

We also offer new manager assimilation and team effectiveness programs and quick tip resources for our experienced leaders.

In addition, we offer intensive Customer Care and Sales New Hire Training.

Competitive Pay and Benefits

7 unchanged sentences

We are committed to providing comprehensive benefit options that allow our employees and their families to live healthier and more secure lives.

Our wide-ranging benefits include health insurance, telehealth, prescription drug benefits, dental insurance, vision insurance, 80 hours of COVID-19 paid sick time, accident insurance, critical illness insurance, life insurance, disability insurance, health savings accounts, flexible savings accounts, retirement plans, employee stock purchase plan, legal services, identity theft protection, maternity/paternity leave, tuition and professional certification course reimbursement, and employee assistance program.

In addition, we offer Pod perks, which provides a free Omnipod 5 or Omnipod DASH product, including PDM/Controller and Pods to benefit eligible employees, interns, or dependents.

Our wide-ranging benefits include health insurance, telehealth, prescription drug benefits, dental insurance, vision insurance, paid time off, sick time, bereavement leave, life insurance, disability insurance, accident insurance, critical illness insurance, hospital indemnity insurance, health savings accounts, flexible savings accounts, retirement plans, employee stock purchase plan, legal services, identity theft protection, paid parental and postpartum recovery leave, tuition and professional certification course reimbursement, business travel accident insurance, pet insurance and employee assistance program.

In addition, we offer Pod perks, which provides a free Omnipod 5 or Omnipod DASH product, including Controller/PDM and Pods to benefit eligible employees or dependents.

We also offer summer hours and flexible work arrangements, including the opportunity to work remotely, which allows us to access a broader, more diverse, and more exceptional talent pool.

11 unchanged sentences

We also have formal plans in place to protect our employees' safety in the event of an emergency.

In addition, our Acton, Massachusetts facility maintains an Emergency Action Plan that describes procedures that employees should follow when faced with a variety of unexpected health and safety events.

As part of this initiative, we have trained certain employees to use automated external defibrillators, provide first aid, and perform cardiopulmonary resuscitation (CPR).

In 2023, we implemented a text emergency system for our employee base located in our Acton headquarters and Acton manufacturing facility, which advises employees on building closures and emergencies with clear instructions.

In addition, our facilities maintain Emergency Action/Preparedness Plans that describe procedures that employees should follow when faced with a variety of unexpected health and safety events.

As part of this initiative, we have trained certain employees to use automated external defibrillators, provide first aid, and perform cardiopulmonary resuscitation (CPR) in the event someone is injured or becomes ill while at work.

We also have internal emergency response teams, comprised of people who are trained to respond to emergencies such as a fire, natural disaster, chemical spill, and/or workplace accident.

Further, we maintain an emergency evacuation map for each location in our plants and conduct mock drills to familiarize staff with our emergency routes, emergency exits, and assembly points.

Additionally, we have a text emergency system for our employee base located in our

Acton headquarters and Acton manufacturing facility, which advises employees on building closures and emergencies with clear instructions.

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.

8 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business