What changed in this filing

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Item 1. Business

2023-02-24 compared with 2022-02-24 · 128 added, 138 removed, 315 unchanged (46% of the section changed)

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The Omnipod System includes:

the Omnipod Insulin Management System (“Omnipod”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), our digital mobile Omnipod platform and the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”).

In addition to the diabetes market space, we have partnered with pharmaceutical and biotechnology companies to tailor the Omnipod System technology platform for the delivery of subcutaneous drugs across other therapeutic areas.

Most 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.

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

In addition, 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.

Market Opportunity:

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

We estimate that approximately four to four and a half million people have type 1 diabetes in the countries we currently serve.

We estimate that approximately five 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.

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

We estimate that approximately seven to seven and a half million people have insulin-requiring type 2 diabetes in the countries we currently serve.

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

We estimate that approximately six million people have insulin-intensive type 2 diabetes in the countries we currently serve.

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.

An even smaller portion of the U.S.

and international insulin-requiring type 2 diabetes population use insulin pump therapy.

and international insulin-intensive type 2 diabetes population use insulin pump therapy.

We believe these factors present a significant available market for the Omnipod System 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.

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

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People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, to provide 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.

There are two primary types of insulin therapy practiced today:

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Insulin pump therapy has been shown to provide numerous advantages relative to MDI therapy.

For example, insulin pump therapy eliminates individual insulin injections (approximately five per day), 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 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.

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.

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We believe the Omnipod System’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 DASH Omnipod 5

The Omnipod System features two discreet and easy-to-use devices that eliminates the need for the external tubing required with conventional pumps:

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It can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh, or lower back.

The Pod delivers precise, personalized doses of insulin into the body through a small flexible tube (called a cannula);

The Pod delivers insulin into the body through a small flexible tube (called a cannula);

• the Personal Diabetes Manager (“PDM”) or Controller, a wireless, handheld device that programs the Pod with the user’s personalized insulin-delivery instructions and wirelessly monitors the Pod’s operation.

Omnipod DASH was fully launched in the United States in 2019 and in our existing international markets in 2020 and 2021.

It features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity, nightly automatic data uploads providing users and their clinicians with cloud access to data, and enhancements for pushing software updates wirelessly to users.

In January 2022, we received clearance from the U.S.

Food and Drug Administration’s (“FDA”) for the commercial distribution of Omnipod 5, which builds on our Omnipod DASH mobile platform.

Omnipod 5 includes an AID algorithm that is located on

The Pod integrates with a third-party continuous glucose monitor (“CGM”) to obtain glucose values.

The embedded algorithm then predicts glucose levels into the future and automatically adjusts insulin dosing intended to reduce the occurrence of blood glucose highs and lows.

The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control and currently integrates with a CGM manufactured by Dexcom, Inc.

In February, we commenced a limited market release of Omnipod 5 in the U.S.

The Omnipod System provides continuous insulin delivery at preset rates, eliminating the need for individual insulin injections.

Additionally, Omnipod 5 is interoperable with a third-party continuous glucose monitor (“CGM”) sold separately that obtains glucose values and integrates with the Pod.

Further, we have partnered with Glooko Inc.

(“Glooko”) to connect our Omnipod System user data with Glooko’s comprehensive diabetes data management system (including Glooko and Diasend in selected regions).

Glooko provides a cloud-based application for clinicians and users accessible through a kiosk, home computer, or a mobile application on the user’s smartphone that provides users and their healthcare providers access to insulin delivery trends, blood glucose levels, and other integrated data.

Omnipod DASH was fully launched in the United States in 2019 and in our international markets starting in 2020.

It features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.

In the U.S., the PDM has nightly automatic data uploads providing users and their clinicians with cloud access to data, and enhancements for pushing software updates wirelessly to users.

Omnipod DASH provides continuous insulin delivery at preset rates, eliminating the need for individual insulin injections.

In addition, insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine.

The Omnipod System works like the pancreas of a person without diabetes by delivering insulin in two ways:

Omnipod DASH delivers insulin in two ways:

• A small, constant background supply of insulin is delivered automatically at a programmed rate, all day and night.

• An extra dose of insulin can be delivered when needed to match the carbohydrates in a snack or meal to correct high blood glucose.

We have designed the Omnipod System to fit within the normal daily routines of users.

The Omnipod System communicates wirelessly, provides for virtually pain-free automated cannula insertion, and eliminates the need for MDI therapy or the use of pump and tubing.

We have designed Omnipod DASH to fit within the normal daily routines of users.

Omnipod DASH communicates wirelessly, provides for virtually pain-free automated cannula insertion, and eliminates the need for MDI therapy or the use of pump and tubing.

The Pod can be worn for up to three days at a time and, because it is waterproof up to 25 feet, there is no need to remove it when showering, swimming, or performing other activities.

The Omnipod System consists of just two devices as opposed to up to seven for tubed insulin pumps.

As a result, the Omnipod System is easy to use, which reduces the training burden on healthcare professionals and users.

We believe that the Omnipod System’s overall ease of use, flexibility, and substantially lower training burden make it very attractive to people with insulin-dependent diabetes and allows healthcare professionals to prescribe pump therapy to a broader group of people with diabetes.

Several publications over the past decade have found that compared to MDI therapy, the use of the Omnipod System by individuals with both type 1 and type 2 diabetes across all age groups is associated with good glycemic control and reduced frequency and severity of hypoglycemic episodes.

These results are consistent with published literature of other continuous subcutaneous insulin infusion devices.

In addition, research in adults with type 1 diabetes has found that compared to prior treatment modality, the use of the Omnipod System is associated with improved quality of life.

We believe that this data is clinically meaningful to healthcare providers and provides support for the use of the Omnipod System in the treatment of both type 1 and type 2 diabetes.

As a result, Omnipod DASH is easy to use, which reduces the training burden on healthcare professionals and users.

We believe that Omnipod DASH’s overall ease of use and flexibility make it very attractive to people with insulin-dependent diabetes and their healthcare professionals.

Omnipod 5, which builds on our Omnipod DASH platform, was cleared by the U.S.

Food and Drug Administration (“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”).

Omnipod 5 includes an AID algorithm that is located on the Pod.

The Pod integrates with a third-party CGM to obtain glucose values trough wireless Bluetooth communication.

The embedded algorithm predicts glucose levels into the future and automatically adjusts insulin dosing intended to achieve user selected glucose targets 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 Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control.

The Omnipod 5 Controller and Omnipod 5 Android app 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 a CGM manufactured by Dexcom, Inc.

Subsequent to the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product.

We plan to phase-out our Classic Omnipod product in the U.S.

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

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This certification is a cybersecurity standard intended to raise confidence in the security of network connected medical devices through independent expert evaluation.

In addition, Insulet’s information security management system is International Organization for Standardization (“ISO”) 27001 certified, which is the international standard for best practice in an information security management system globally.

In addition, Insulet’s information security management system is International Organization for Standardization (“ISO”) 27001 and 27701 certified, which are the international standard for best practice in an information security management system globally.

With the DTSec and ISO certifications, Insulet is globally recognized for incorporating the highest standards for cybersecurity and information security and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.

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In addition, Omnipod 5 utilizes state-of-the-art authentication, encryption, and cybersecurity protection that enables the use of approved personal smartphone devices.

We have partnered with Glooko Inc.

(“Glooko”) to connect our Omnipod System user data with Glooko’s comprehensive diabetes data management system (including Glooko and Diasend in selected regions).

Third-Party Reimbursement

In the United States, our products are sold directly to consumers, as well as wholesalers, private healthcare organizations, healthcare facilities, mail order pharmacies, and independent retailers.

In the United States, our products are sold to wholesalers, private healthcare organizations, healthcare facilities, mail order pharmacies, and independent retailers, as well as directly to consumers.

These entities, and the Company in some cases, seek reimbursement from health insurance companies and/or government administrative payors.

In the United States, consumers generally have commercial insurance, Medicare or Medicaid coverage that pays for the product.

The Omnipod System’s unique patented design allow us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-

party payors in the U.S.

The Omnipod System’s unique patented design allows us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the U.S.

In certain international locations in which we sell through a distributor or intermediary, our distribution partners and local intermediaries establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.

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Belgium Germany Netherlands Turkey

Canada Greece Norway United Kingdom

Croatia Iceland Qatar United States

Denmark Israel

Canada Greece Norway United Arab Emirates

Croatia Iceland Qatar United Kingdom

Denmark Israel Saudi Arabia United States

We sell the Omnipod System directly to consumers, through distribution partners and in the U.S.

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Distributor B 17% 12% 10%

Distributor C * 10% 11%

Distributor D 16% * *

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

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• Building consumer awareness about the features and benefits that the Omnipod System provides to simplify diabetes management.

• Strengthening physician support by demonstrating the clinical evidence of how the Omnipod system improves outcomes and quality of life, and providing data and insights to physicians offering diabetes care.

• Strengthening physician support by demonstrating clinical evidence of how the Omnipod System improves outcomes and quality of life and providing data and insights to physicians offering diabetes care.

• Providing payors with the clinical and economic justifications for why the Omnipod System offers unique value to the people whom they insure.

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

With the launch of Omnipod DASH, we created an online training program for Omnipod customers transitioning to Omnipod DASH or Omnipod 5.

In addition, due to the challenges COVID-19 has presented, we have also been using virtual training to onboard new Omnipod customers transitioning from MDI.

Our virtual capabilities have allowed us to continue to onboard new customers despite COVID-19 in a cost-effective manner.

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

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.

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The Omnipod System competes for consumers in the insulin delivery market.

Because most new Omnipod System 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 System 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.

Medtronic historically has held the

majority share of the tubed insulin pump market.

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

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Research and Development

Our research and development efforts are primarily focused on making improvements to the Omnipod System, including adding features and functionality that will deliver clinical outcomes, economic value, convenience, and simplicity to users.

Throughout 2021, we worked to receive FDA clearance for Omnipod 5 for individuals aged six years and older with type 1 diabetes, which was obtained in January 2022.

In 2021, we also completed our Omnipod 5 clinical study of pediatric users ages two to six years old, and in 2022, we filed for clearance of this expanded indication.

We have also filed for CE Mark approval of Omnipod 5.

During 2021, we completed our Omnipod 5 feasibility study for individuals with type 2 diabetes, and we plan to conduct additional studies with the goal of expanding Omnipod 5’s indications.

In addition, we have a development agreement to integrate Abbott Diabetes Care, Inc.’s CGM with Omnipod 5 in the future, and are also working on developing an iOS app that could be utilized to control Omnipod 5 Pods.

In addition to our focus on Omnipod 5, we are also working on innovation programs designed to drive:

Our innovation programs are designed to drive:

• simplicity of user interaction with our systems;

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• user choice of sensor and smartphone integrations.

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

In 2022, we received FDA clearance for Omnipod 5 for individuals aged two years and older with type 1 diabetes and received CE Mark approval for Omnipod 5 under the European Union MDR.

We plan to begin a pivotal trial for Omnipod 5 in 2023 with the goal of expanding Omnipod 5’s indications to individuals with type 2 diabetes.

In addition, we have a development and commercialization agreement to integrate Abbott Diabetes Care, Inc.’s CGM with Omnipod 5 in the future and are also working on developing an iOS app that could be utilized to control Omnipod 5 Pods.

Additionally, in November 2022, we submitted our 510(k) application to the FDA for a basal-only Pod for individuals with type 2 diabetes, which is a version of Omnipod specifically designed for customers on basal-only therapy.

The basal-only Pod is designed to deliver a fixed rate of rapid-acting insulin for 72 continuous hours and does not require a PDM/Controller or phone application for use.

Manufacturing and Quality Assurance

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In 2019, we began producing product at our highly automated manufacturing facility in Acton, Massachusetts and in 2020 and 2021, we began producing on additional lines in this facility.

In addition to increasing supply redundancy and adding capacity closer to our North American customer base to support the growth of our business, we expect that once the Acton facility is operating at full capacity, the highly automated assembly process will be able to produce a globally cost competitive product.

The Acton facility increases supply redundancy and adds capacity closer to our North American customer base to support the growth of our business.

We also produce our devices on manufacturing lines at a facility in Kunshan (Shanghai), China operated by a contract manufacturer.

This contract manufacturing agreement expires in December 2022 and is subject to automatic renewal, unless canceled by either party under the terms of the contract.

We have recently optimized our operations in China by consolidating our production in that region into this one location.

Additionally, we plan to invest in a new manufacturing plant in another international location to further diversify globally and increase efficiency.

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.

We have optimized our operations in China by consolidating our Omnipod production in that region into this one location.

Additionally, in 2022, we broke ground on a new manufacturing plant in Malaysia to support our international expansion strategy and further ensure product supply.

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

In addition, in January 2022, we acquired one of our suppliers to bring key intellectual property and expertise in-house, strengthen our production capabilities and mitigate supply chain risks.

In January 2022, we acquired one of our suppliers to bring key intellectual property and expertise in-house, strengthen our production capabilities and mitigate supply chain risks.

Raw Materials

We use a broad range of raw materials in the assembly and manufacturing of the Omnipod System.

We purchase all our raw materials and select components used in the manufacturing of our products from external suppliers.

We purchase our raw materials and select components used in the manufacturing of our products from external suppliers.

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.

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These sole sourced components are critical to the design and functionality of the Omnipod System.

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

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

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.

We work closely with all suppliers to ensure continuity of supply while maintaining high quality and reliability.

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

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

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

Processes utilized in the manufacture, test, and release of the Omnipod System have been verified and validated as required by the FDA and other regulatory bodies.

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

• the Omnipod shape memory alloy drive system;

• the Omnipod System cannula insertion system;

• communication features between system components for the Omnipod System and next generation products;

• software, such as apps, for controlling the Omnipod System and next generation products;

• the Omnipod drive system;

• the Omnipod cannula insertion system;

• control features of the Omnipod System and next generation products;

• software, such as algorithms and apps, for controlling the Omnipod System and next generation products;

• various novel aspects of the Omnipod System, potential future generations of Omnipod Systems, and other mechanisms for the delivery of pharmaceuticals.

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Our trademarks include INSULET TM , OMNIPOD ® , OMNIPOD ® 5 Automated Insulin Delivery System, SIMPLIFY LIFE TM , Omnipod DASH ® , Omnipod DISPLAY ® , Omnipod VIEW TM , SmartAdjust TM , Pod Pals ® , Podder ® , and PodderCentral ® .

Recent Intellectual Property Agreement s

In February 2023, we entered into a Patent Assignment and License Agreement with Bigfoot Biomedical, Inc.

(“Bigfoot”), pursuant to which we acquired approximately 400 patents as well as a significant number of global patent applications, and licensed a large number of additional patents and patent applications on a fully paid-up exclusive or non-exclusive basis.

In October 2022, we entered into a mutual agreement with Medtronic, Inc., not to assert our patents against each other for certain technologies in the field of diabetes.

With certain exclusions, this agreement applies to the companies’ existing products, as well as new products for at least the next seven years.

No payments have been or will be exchanged as part of the agreement.

The agreement replaces and terminates the Settlement and Cross License Agreement, dated September 18, 2013, by and between us and Medtronic.

Government Regulation

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We have obtained 510(k) clearance for the Omnipod, Omnipod DASH, and Omnipod 5 Systems and expect that regulatory approval 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.

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.

510(k) Clearance .

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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.

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 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.

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.

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The federal Anti-Kickback Statute has been interpreted to apply to arrangements between drug and medical device manufacturers and suppliers on one hand and prescribers, patients, purchasers, and formulary managers on the other.

Liability under the statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it.

In addition, claims resulting from a violation of the federal Anti-Kickback Statute constitute false or fraudulent claims for purposes of the federal civil False Claims Act, which is addressed below.

under the statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it.

In addition, claims resulting from a violation of the federal Anti-Kickback Statute constitute false or fraudulent claims for purposes of the federal civil False Claims Act discussed below.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common business practices from prosecution and administrative sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be perceived as inducing the prescription, purchase, or recommendation of the Omnipod System may be subject to scrutiny under the law.

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We have structured our arrangements with diabetes educators and other business practices to comply with statutory exemptions and regulatory safe harbors whenever possible, but our practices may be subject to scrutiny if they fail to strictly comply with the criteria in the exemption or regulatory safe harbor.

Moreover, there are no safe harbors for many common practices such as

providing reimbursement assistance, coding and billing information, or other customer assistance and product support programs.

Moreover, there are no safe harbors for many common practices such as providing reimbursement assistance, coding and billing information, or other customer assistance and product support programs.

If any of our practices, arrangements, or programs are found to violate the federal Anti-Kickback Statute, we could be subject to significant criminal, civil, and administrative penalties, including imprisonment, fines, damages, and exclusion from Medicare, Medicaid, or other governmental programs.

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Several states have enacted various privacy laws.

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

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.

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 and is to take effect in January 2023 with respect to personal data collected beginning in January 2022.

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 on July 1, 2023.

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

Colorado and Virginia have enacted similar laws, also with effective dates in 2023.

Virginia and Colorado have enacted similar laws.

The Consumer Data Protection Act became effective in Virginia on January 1, 2023, and the Colorado Privacy Act is effective July 1, 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.

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These reforms are intended in part to put increased emphasis on the delivery to patients of more cost-effective therapies and could adversely affect our business.

Some of the provisions of the ACA have yet to be fully implemented, and certain provisions have been subject to judicial and Congressional challenges.

In addition, there have been efforts to repeal or replace certain aspects of the ACA and to alter the implementation of the ACA and related laws.

It is unclear how the ACA and its implementation, as well as efforts to repeal or replace, or invalidate, the ACA, or portions thereof, will affect our business.

Additional legislative changes, regulatory changes, and judicial challenges related to the ACA remain possible.

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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.

Beginning in 2022, applicable manufacturers also will be 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.

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.

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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 federal and state regulations or the effect their application will have on us.

As a result, our provider and training arrangements may ultimately be found not to be in compliance with applicable federal law.

Moreover, these laws continue to evolve.

The Bipartisan Budget Act of 2018 increased the criminal and civil penalties that can be imposed for violating certain federal healthcare laws, including the Anti‑Kickback Statute.

Additionally, in late 2020, the United States Department of Health and Human Services’ Office of the Inspector General (“OIG”) finalized a rule that will remove protection from the discount safe harbor to the federal healthcare Anti-Kickback Statute for manufacturers rebates to pharmacy benefit managers (or “PBMs”), Medicare Part D plans and Medicaid managed care organizations (“MCOs”), effective January 2022.

The rule also includes a new safe harbor for point-of-sale reductions offered by manufacturers to Part D plans, Medicaid MCOs and their PBMs, and a new safe harbor for certain fees manufacturers pay to PBMs for services to the manufacturers.

The rule was finalized consistent with an Executive Order issued by the President in 2020;

with the change in Administrations, it is possible that the rule may be revised before it is fully effective.

If it takes effect as written, the rule will be one of the most significant amendments to the Anti-Kickback Statute regulatory safe harbors in decades and likely will transform manufacturer interactions with Part D plans, Medicaid MCOs and their PBMs.

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

As a result, our provider and training arrangements may ultimately be found not to be in compliance with applicable laws.

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.

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Foreign Corrupt Practices Act ( “ FCPA ” ).

We are also subject to FCPA in the U.S.

We are subject to FCPA in the U.S.

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.

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Our policies mandate compliance with these anti-bribery laws.

We operate in parts of the world that have experienced governmental corruption to some degree, and in certain circumstances strict compliance with

anti-bribery laws may conflict with local customs and practices.

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.

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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 Medical Device Regulation (“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.

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”.

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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 the Omnipod and Omnipod DASH Systems, which allows us to distribute these products throughout the European Union and in other countries that recognize the CE Mark.

In addition, we have Health Canada approval to sell these products in Canada.

We have obtained the right to affix the CE Mark to the Omnipod and Omnipod DASH Systems under the MDD and to the Omnipod 5 System under MDR, which allows us to distribute these products throughout the European Union and in other countries that recognize the CE Mark.

In addition, we have Health Canada approval to sell Classic Omnipod and Omnipod DASH in Canada.

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.

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To assess and improve employee retention and engagement, we survey employees with the assistance of third-party consultants, and take timely action to address key areas of employee concern.

We regularly conduct engagement surveys to gain valuable insight into our employees’ experience and identify areas for improvement.

In 2021, we heard from employees through a variety of surveys focused on wellness, work-life balance, and the workplace of the future.

In 2022, we implemented a new approach to engagement.

Instead of conducting an engagement survey once per year, we will perform short pulse surveys three to four times per year to better understand opportunities to improve our talent management strategy and gain a more dynamic view of our employees’ needs.

We conduct engagement surveys to gain valuable insight into our employees’ experience and identify areas for improvement.

In 2022, instead of conducting an engagement survey once per year, we launched ‘Your Voice’ pulse surveys, which are conducted more often, to better understand opportunities to improve our talent management strategy and gain a more dynamic view of our employees’ needs.

Our senior leadership team assesses engagement to understand and identify potential opportunities for improvement.

Our executive leadership team 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 video updates from leaders around the world.

This initiative also includes virtual meetings with our executive team members.

These virtual meetings are designed as casual conversations with our executives so

employees can talk about what is on their minds, get to know the executive leaders, and connect with colleagues from across the organization.

We also utilize a social networking tool to ensure our global employees are engaged, motivated, and collaborating with one another.

Diversity, Equity, and Inclusion

To help our remote employees feel socially connected to their colleagues, we created our “Stay Connected” initiative, which includes virtual meetings with our executive team members.

These virtual meetings are designed as casual conversations with our executives so employees can talk about what is on their minds, get to know the executive leaders, and connect with colleagues from across the organization.

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 aspire to create a diverse and inclusive global culture that reflects the diversity of the customers we serve and fosters an environment where all employees feel welcomed, respected, and valued.

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.

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

Our annual three-day leadership program includes instruction in unconscious bias and hiring behaviors that support diversity.

We have talent programs that foster a diverse talent pipeline by recruiting candidates with a wide variety of backgrounds.

Our Employee Resource Groups (“ERG”) serve as a source of inclusion across seven categories:

African Descent, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, and Young Professionals.

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

In 2022, 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 2022, we worked to embed diversity more formally into our talent acquisition process to attract a diverse pool of candidates.

In addition, we launched our flagship diversity training, Conscious Inclusion, to all employees.

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

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

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

Training and Development

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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, and other business topics designed to engage and connect employees to each other and our mission.

Due to the COVID-19 pandemic, we transformed our regional on-boarding program for new hires to a global, virtual program.

We also offer intensive Customer Care New Hire Training and Sales (Field and Inside Sales) New Hire Training.

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.

We also offer 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.

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We offer leadership development programs to support the growth of our future leaders.

We also offer training for new managers and resources for experienced leaders.

We also offer training for new managers and resources for our experienced leaders.

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.

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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, legal services, identity theft protection, maternity/paternity leave, and employee assistance program.

In addition, we offer a free online wellness program;

subsidized child, senior care or pet services, and access to personal services;

free virtual babysitting and tutoring services;

Pod perks, which provides a free Omnipod System, including PDM and Pods to benefit eligible employees, interns, or dependents;

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, and employee assistance program.

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

summer hours;

and a flexible work policy.

In addition, our employee stock purchase plan is available to all full-time employees and has a participation rate of over 60%.

In additional to the above, we continued our commitment to flexibility through our Future of Work program.

Our Future of Work program and Global Flexible Working Arrangement Policy are rooted in a “choice with responsibility” philosophy.

Our sustained commitment to flexibility enables access to a broader, more diverse, and more exceptional talent pool.

Health and Safety

We maintain an occupational health and safety management system that covers all our employees and contractors, because we are committed to the safety and well-being of our workforce.

We maintain an occupational health and safety management system that covers all our employees, contractors, and temporary employees because we are committed to the safety and well-being of our workforce.

By minimizing risks at our factories and implementing training to enhance awareness of hazards, we are able to promote safe practices and preserve the health of our employees.

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We maintain high standards for workplace safety, and our orientation for technicians includes training about safe procedures, such as lockout/tagout.

All employees working in our machine shop must also attend training to understand and comply with safety protocols.

We have a Health and Safety Compliance Manual to provide employees with the tools needed to identify and report hazards and reduce work-related injuries.

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Occupational Safety and Health Administration requirements.

We continuously monitor and adapt to regional regulations as we expand our facilities into new geographies.

In addition to hazard recognition, our workplace health and safety programs cover ergonomics, hearing conservation, fall protection, and accident and injury prevention.

Furthermore, we added a detailed program on contractor safety in 2021 to support the health and well-being of the contractors who work with us on various aspects of our operations every day.

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

In addition, we have an Emergency Action Plan for our Acton, Massachusetts facility that outlines processes that our employees must follow during unexpected events.

We also have formal plans in place to protect our employee’s 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 trained certain employees to use automated external defibrillators, provide first aid, and perform cardiopulmonary resuscitation (CPR).

We are also planning to schedule annual emergency evaluation drills to enhance the safety of our facility.

In response to COVID-19, we organized an internal cross-functional Coronavirus Task Force to manage our response to the pandemic and maintain business continuity while aligning with safety protocols recommended by the World Health Organization, the U.S.

Centers for Disease Control and Prevention, and other local health agencies.

In addition, to ensure the safety of our essential employees who work in our owned and contract manufacturing facilities during the pandemic, we implemented additional screening processes and provided masks, sanitizer, and other personal protective equipment.

We also initiated contact tracing and offered COVID-19 testing for all employees in the U.S.

and offered vaccination clinics at our principal U.S.

office and manufacturing location.

In addition, we 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.

What changed 10-K

Item 1. Business