What changed in this filing

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Item 1. Business

2022-02-24 compared with 2021-02-24 · 171 added, 159 removed, 282 unchanged (54% of the section changed)

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The Omnipod System includes:

the Omnipod Insulin Management System (“Omnipod”) and the Omnipod DASH TM Insulin Management System (“Omnipod DASH” or “DASH”), our digital mobile Omnipod platform.

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 white blood cell booster to help reduce the risk of infection after intense chemotherapy.

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.

Market Opportunity:

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In people with diabetes, blood glucose levels fluctuate between very high levels, a condition known as hyperglycemia, and very low levels, a condition called hypoglycemia.

Hyperglycemia can lead to serious short-term complications, such as confusion, vomiting, dehydration and loss of consciousness and long-term complications, such as blindness, kidney disease, nervous system disease, occlusive vascular diseases, stroke and cardiovascular disease, or death.

Hyperglycemia can lead to serious short-term complications, such as confusion, vomiting, dehydration, and loss of consciousness and long-term complications, such as blindness, kidney disease, nervous system disease, occlusive vascular diseases, stroke, cardiovascular disease, or death.

Hypoglycemia can lead to confusion, loss of consciousness, or death.

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

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

We estimate that approximately four to four and a half 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 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 Type 1 diabetes population outside the United States use insulin pump therapy.

An even smaller portion of the Type 2 diabetes population in and outside of the United States who are insulin-dependent use insulin pump 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.

An even smaller portion of the U.S.

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

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

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Diabetes is often frustrating and difficult for people to manage.

Blood glucose levels can be affected by the carbohydrate and fat content of meals, exercise, stress, illness or impending illness, hormonal releases, variability in insulin absorption and changes in the effects of insulin on the body.

Blood glucose levels can be affected by the carbohydrate and fat content of meals, exercise, stress, illness, impending illness, hormonal releases, variability in insulin absorption, and changes in the effects of insulin on the body.

For people with insulin-dependent diabetes, many corrections, consisting of the administration of additional insulin or ingestion of additional carbohydrates, are needed throughout the day in order to maintain blood glucose levels within normal ranges.

Achieving this result can be very difficult without multiple daily injections of insulin or insulin pump therapy.

Individuals with diabetes attempting to control their blood glucose levels tightly to prevent the long-term complications associated with fluctuations in blood glucose levels are at greater risk for overcorrection and the resultant hypoglycemia.

Achieving this result can be very difficult with multiple daily injections of insulin.

As a result, many people have difficulty managing their diabetes.

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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.

There are two

primary types of insulin therapy practiced today:

other physiological reasons.

There are two primary types of insulin therapy practiced today:

multiple daily injections (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.

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Insulin pump therapy allows individuals to customize their bolus and basal insulin doses to meet their insulin needs throughout the day and is intended to more closely resemble the physiologic function of a healthy pancreas.

Insulin pumps are used to perform continuous subcutaneous insulin infusion and typically use a programmable device and an infusion set to administer insulin into the person’s body.

Insulin pumps perform continuous subcutaneous insulin infusion and typically use a programmable device and an infusion set to administer insulin into the body.

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

For example, insulin pump therapy 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.

We believe that these advantages, along with technological advancements and increased awareness of insulin pump therapy will continue to generate demand for insulin pump devices.

We believe that these advantages, along with technological advancements, including the use of continuous glucose monitoring technology and automated insulin device (“AID”) algorithms, and increased awareness of insulin pump therapy will continue to generate demand for insulin pump devices.

Our Solution:

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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.

Pod Omnipod PDM Omnipod DASH PDM

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

• the Personal Diabetes Manager (“PDM”), 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, launched in the United States in 2019 and in 2020 in our international markets, features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.

In addition, the updated release launched in June 2020 features an option to choose Spanish language, nightly automatic data uploads providing users and their clinicians with cloud access to data, and the ability for us to push software updates wirelessly to users.

• 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.

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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 traditional MDI therapy or the use of traditional pump and tubing.

It can be worn for up to three days at a time and, because it is waterproof, 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 conventional tubed insulin pumps.

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

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.

The Omnipod System’s unique patented design and proprietary manufacturing process 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., compared to conventional tubed insulin pumps.

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.

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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.

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

Omnipod DASH is the first FDA-cleared insulin pump certified under the Diabetes Technology Society’s “Standard for Wireless Diabetes Device Security” cybersecurity assurance standard and program, known as DTSec.

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.

With the DTSec and ISO 27001 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.

Insulet continues to advance the cybersecurity capabilities of our medical devices.

Omnipod 5 is globally recognized for incorporating the highest standards for information and cyber security by design, which includes secure data transfer between the Pod and the Controller, as well as secure cloud storage.

Omnipod 5 is certified by ISO 27001 and the U.K.

Cyber Essentials.

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).

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 health care providers access to insulin delivery trends, blood glucose levels and other integrated data.

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.

Third-Party Reimbursement

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

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.

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

The Omnipod System is also marketed and sold through distributors, as well as marketed to physicians and consumers.

Our products are subject to regulatory changes and competition in technological innovation, price, convenience of use, service and product performance.

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

In certain non-U.S.

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.

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.

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.

Markets and Distribution Methods

The Omnipod System is currently available in the United States, Canada and in certain countries in Europe and the Middle East.

The Omnipod System is currently available in the following countries:

Australia Finland Italy Sweden

Austria France Kuwait Switzerland

Belgium Germany Netherlands Turkey

Canada Greece Norway United Kingdom

Croatia Iceland Qatar United States

Denmark Israel

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

also through the pharmacy channel.

For the year ended December 31, 2020, approximately 70% of our Omnipod System sales were through intermediaries.

Revenue for customers comprising 10% or more of total revenue was as follows:

For the year ended December 31, 2021, 76% of our Omnipod System sales were through intermediaries.

The Omnipod System is also marketed to physicians.

The percentages of total revenue for customers that represent 10% or more of total revenue was as follows:

Years Ended December 31,

2021 2020 2019

Cardinal Health Inc.

and affiliates 10% 11% 12%

Distributor A 10% 11% *

Distributor B 12% 10% 11%

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

Our sales and marketing efforts are focused on customer retention and growing user, clinician and payor demand for the Omnipod System.

We have a uniform sales and marketing approach, aligned across users, physicians and providers, to capitalize on the unique benefits of our Omnipod System technology.

We have three areas of focus:

• Build consumer awareness about the features and benefits that the Omnipod System provides.

• Build physician support by increasing the clinical evidence that demonstrates the benefits that the Omnipod System provides and improving the monitoring data available to physicians providing diabetes care.

• Provide payors with the clinical and economic justification for why the Omnipod System provides a unique value to the people whom they insure.

We believe that training consumers how to use the Omnipod System is an important factor to promote successful outcomes and customer retention.

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

We have a comprehensive sales and marketing approach, which communicates the benefits of the Omnipod System to users, physicians and providers.

This includes three areas of focus:

• 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.

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

We believe that training consumers on how to use the Omnipod System is an important factor to promote successful outcomes and customer retention.

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 DASH customers transitioning from Omnipod.

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 and in a cost-effective manner.

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

Our distributors and intermediaries have also implemented virtual training programs.

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We seek to provide our customers with high quality customer support, from product ordering to insurance investigation, order fulfillment and ongoing support.

We have integrated our customer support systems with our sales, reimbursement and billing processes and offer support by telephone and through our website to provide customers with seamless and reliable support.

Our customer support systems are integrated with our sales, reimbursement and billing processes, allowing us to provide customers with seamless and reliable support by telephone and through our website.

The diabetes medical device market is highly competitive, subject to rapid change and significantly affected by new product introductions.

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

Because most new Omnipod System end-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.

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

In addition, we compete with Roche Holdings Ltd.

(“Roche”) and The Ypsomed Group (“Ypsomed”) outside the United States.

Medtronic historically has held the majority share of the conventional tubed insulin pump market in the United States.

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.

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 economic value, convenience and simplicity to users.

Omnipod 5, powered by Horizon TM Automated Insulin Delivery System ( “ Omnipod 5 ” )

We are developing an automated insulin delivery (“AID”) system that utilizes the DASH mobile platform to allow the Pod, our automated insulin delivery algorithm located on the Pod and the glucose sensor values obtained directly from a third party’s continuous glucose monitor (“CGM”) to predict glucose levels into the future and automatically adjust the insulin dose required

to help reduce the occurrence of blood glucose highs and lows.

We plan to launch Omnipod 5 with a CGM manufactured by Dexcom, Inc.

and compatibility with the Android platform.

In addition, we have signed a development agreement to integrate Abbott Diabetes Care, Inc.’s CGM in the future and are also working on developing compatibility with iOS.

Omnipod 5 is intended to be controllable through a secure mobile app on the user’s smartphone (i.e.

“phone control”).

We completed the first phase of our Omnipod 5 pivotal trial in October 2020.

We also recently completed our Omnipod 5 clinical study of pediatric users ages two to six years old and are planning for an expanded indication by the end of 2021.

In addition, we have begun enrolling individuals with Type 2 diabetes in an Omnipod 5 feasibility study.

Based on the results of the feasibility work, we plan to conduct additional studies with the goal of expanding Omnipod 5’s indications.

Omnipod 5 was granted designation in the U.S.

Food and Drug Administration’s (“FDA”) breakthrough device program, which is a program intended to help people have more timely access to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by expediting the development and review process.

We believe that recent and ongoing developments in the use of CGM technology and AID algorithms in conjunction with insulin pump therapy will continue to provide people with insulin-dependent diabetes benefits that will make insulin pump therapy an even more attractive treatment alternative to existing MDI therapy.

Paramount to our ability to deliver phone control is our commitment to cyber and information security.

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

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

With the DTSec and ISO 27001 certifications, Omnipod DASH is globally recognized for incorporating the highest standards for cyber and information security and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.

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:

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We believe a key contributing factor to the overall attractiveness and success of the Omnipod System is the disposable nature of the Pod.

In order to manufacture sufficient volumes and achieve a cost-effective per unit production price for the Omnipod, we have designed the Omnipod System to be manufactured through automation.

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

We completed the installation our third U.S.

manufacturing line and expect to produce sellable product on this line in 2021.

Our Acton facility has the capacity to house up to four lines.

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 fully utilized, the highly automated assembly process will be able to produce a globally cost competitive product.

In addition, we continue to produce our devices on varying degrees of semi-automated manufacturing lines at a facility in China operated by a contract manufacturer.

In 2020, we invested in another contract manufacturer in China allowing us to leverage our local supplier base.

These contract manufacturing agreements expire in December 2022 and October 2021, respectively, and are subject to automatic renewal, unless canceled by the parties under the terms of the contracts.

In order to manufacture sufficient volumes at high quality and achieve a cost-effective per unit production price for the Omnipod, we have designed the Omnipod System to be manufactured through automation.

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.

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.

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.

Raw Materials

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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.

We rely on a limited number of suppliers for certain of the components and sub-assemblies used in the manufacture of the Omnipod System, including application-specific integrated circuit chips, Bluetooth low-energy chips and other specialized parts.

The design of certain of these components and sub-assemblies (including, in some instances, the raw materials used to manufacture them) is proprietary and the intellectual property rights

may be owned exclusively by one party.

We rely on a limited number of suppliers for a certain number of the components and sub-assemblies used in the manufacture of the Omnipod System, including application-specific integrated circuit chips, Bluetooth low-energy chips, and other specialized parts.

The design of certain components and sub-assemblies (including, in some instances, the raw materials used to manufacture them) is proprietary and the intellectual property rights may be owned exclusively by one party.

In such cases, we are sole sourced with the supplier controlling the intellectual property rights.

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

In the case of sole sourced parts, we manage risk through holding inventory ourselves and at the supplier to ensure continuity of supply and low risk of disruption.

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

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.

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 approval of our Quality Management System from BSI Group, an accredited Notified Body for CE Marking, and from ISO.

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.

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

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

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

• the Omnipod shape memory alloy drive system;

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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 TM , OMNIPOD ® , OMNIPOD ® 5 Automated Insulin Delivery System, SIMPLIFY LIFE TM , Omnipod DASH ® , Omnipod CONTROL TM , Omnipod DISPLAY ® , Omnipod VIEW ® , OMNIPOD U-200 TM , OMNIPOD U-500 TM , Pod Pals ® and Podder TM .

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 ® .

Government Regulation

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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 the Omnipod and Omnipod DASH 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.

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.

510(k) Clearance .

To obtain 510(k) clearance for any of our potential future devices (or for certain modifications to devices that have previously received 510(k) clearance), we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device.

The FDA’s 510(k) clearance pathway generally takes three to twelve months from the date the application is completed but can take significantly longer.

The FDA’s 510(k) clearance pathway generally takes three to 12 months from the date the application is completed but can take significantly longer.

A 510(k) application must be supported by extensive data, including technical information, labeling, and potentially clinical data to meet any Special Controls and to demonstrate the safety and effectiveness of the device to the FDA’s satisfaction.

After a medical device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a significant change in its intended use, requires a new 510(k) clearance or, depending on the modification, could require a PMA application.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination.

If the FDA disagrees with a manufacturer’s determination regarding whether a new pre-market submission is required for the modification of an existing device, the FDA can, at its discretion, require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA is obtained.

In addition, in these circumstances, we may be subject to significant regulatory fines or penalties for failure to submit the requisite 510(k) or PMA application(s).

The FDA requires each manufacturer to make this determination initially, but if the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA is obtained and assess significant regulatory fines or penalties for failure to submit the requisite 510(k) or PMA application(s).

Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, and devices deemed not substantially equivalent to a previously cleared 510(k) device generally require a PMA before they can be commercially distributed.

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Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval.

After pre-market approval, a new pre-market approval application or application supplement may be required in the event of modifications to the device, its labeling, intended use or indication, or its manufacturing process.

After PMA, a new PMA application or application supplement may be required in the event of modifications to the device, its labeling, intended use or indication, or its manufacturing process.

PMA supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.

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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.

Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate IRB at each clinical trial site.

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.

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 not be sufficient for us to obtain approval of our product.

Even if a clinical trial is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise insufficient for us to obtain approval of our product.

Ongoing Regulation.

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• the referral of an individual;

• furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other federal health care programs;

• the purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of, any item or service reimbursable under Medicare, Medicaid or other federal health care programs.

• furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid, or other federal healthcare programs;

• the purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of, any item or service reimbursable under Medicare, Medicaid, or other federal healthcare programs.

The federal 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.

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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.

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.

For example, we provide the initial training to users necessary for appropriate use of the Omnipod System either through our own diabetes educators or by contracting with outside diabetes educators that have completed a Certified Pod Trainer training course.

We compensate outside diabetes educators for their services at contracted rates deemed to be consistent with the market.

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

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

If any of our practices, arrangements or programs are found not to be in compliance with 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, any of which could have a material adverse effect on our business and results of operations.

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.

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.

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.

Although there are a number of statutory and regulatory exceptions protecting certain common business practices implicating the Stark Law, and we have structured our arrangements with physicians and other providers to comply with these exceptions, these arrangements may not expressly meet the requirements for applicable exceptions from the law.

Although there are statutory and regulatory exceptions protecting certain common business practices, and we have structured our arrangements with physicians and other providers to comply with these exceptions, these arrangements may not expressly meet the requirements for applicable exceptions from the Stark Law.

Federal Civil False Claims Act.

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Actions under the False Claims Act may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government.

Violations of the False Claims Act are subject to the imposition of significant per claim penalties, three times the amount of damages that the federal government sustained and possible exclusion from participation in federal health care programs like Medicare and Medicaid.

We believe that we are in compliance with the federal government’s laws and regulations concerning the filing of claims for reimbursement.

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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 Health Care Fraud Statutes.

We are also subject to a federal health care fraud statutes that, among other things, impose criminal and civil liability for executing a scheme to defraud any health care benefit program including non-governmental programs, and prohibits 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 health care benefits, items or services.

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

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

State Fraud and Abuse Laws and Marketing Restrictions.

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In some cases, these state laws apply regardless of the payor, including private payors.

We believe that we are in conformance with such laws.

Moreover, several states have imposed requirements to disclose payments to health care providers, restrictions on marketing and other expenditures, and requirements to adopt a code of conduct or compliance program with specific elements.

We believe that we are in compliance with such laws.

Moreover, several states have imposed requirements to disclose payments to healthcare providers, restrictions on marketing and other expenditures, and requirements to adopt a code of conduct or compliance program with specific elements.

Liability under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

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If we are found to be in violation of HIPAA, we could be subject to civil or criminal penalties.

California Consumer Privacy Act and California Privacy Rights Act.

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 that became effective in January 2020.

Privacy Laws.

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

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.

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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.

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.

Patient Protection and Affordable Care Act .

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Failure to disclose reportable payments could subject us to penalties and materially adversely impact our business and financial results.

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

As 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.

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

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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 health care laws, including the Anti‑Kickback Statute.

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.

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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.

Such a challenge could have a material adverse effect on our business, financial condition and results of operations.

Even if we are not found to have violated the law, responding to lawsuits, government investigations or enforcement actions, defending any claims raised, and paying any resulting settlement amounts would be expensive and time-consuming, and could have a material adverse effect on our reputation and business operations.

Foreign Corrupt Practices Act ( “ FCPA ” ).

We are also subject to FCPA and similar anti-bribery laws in non-U.S.

jurisdictions, which generally prohibit companies and their intermediaries from making improper payments to non-U.S.

officials for the purpose of obtaining or retaining business.

We are also 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.

Because of the predominance of government-sponsored healthcare systems around the world, our customer relationships outside of the United States may be with governmental entities and therefore subject to such anti-bribery laws.

Our policies mandate compliance with these anti-bribery laws.

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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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 Medical Device Regulation (“MDR”), which will replace MDD in May 2021.

Devices that comply with the requirements of the relevant directive will be entitled to bear the CE conformity marking and, accordingly, can be commercially distributed.

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

Outside the United States 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.

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.

These laws include the U.K.

Bribery Act and similar antibribery laws in other jurisdictions in which we operate.

Such laws generally prohibit U.S.-based companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business to non-U.S.

officials, or in the case of the U.K.

Such laws generally prohibit U.S.-based companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business to foreign officials, or in the case of the U.K.

Bribery Act, to any person.

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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, 2020, we had approximately 1,900 full-time employees,

representing a 41% increase over the prior year.

As of December 31, 2021, we had approximately 2,300 full-time employees, representing a 21% increase over the prior year.

Approximately 80% of our employees are located in the United States and the remainder are located in 13 other countries.

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

In 2020, 90% of our employees responded to the survey.

We supplement this anonymous survey with additional surveys throughout the year.

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.

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

Our executive leadership team conducts quarterly Town Hall meetings to ensure our global employees are highly engaged and receive timely business updates.

To help our employees feel socially connected to their colleagues while working remotely due to COVID-19, we created our “Stay Connected” initiative, which includes weekly video updates from leaders around the world.

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 have also implemented new technology platforms, including a social networking tool, to ensure our global employees are engaged, motivated, and collaborating with one another.

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

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

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

Accordingly, we are committed to providing equal opportunity in all aspects of employment.

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.

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 targeted recruitment programs for veterans and university students, including those of diverse backgrounds.

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, LGBTQ+, Sustainability, Veterans and First Responders, Women, Working Parents, and Young Professionals.

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.

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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.

Employees have access to monthly learning programs and virtual and online learning programs.

On June 1, 2020, we launched a new learning platform to all worldwide employees, which provides a daily professional development topic and includes a library of topics for our busy workforce.

Since the launch, through December 31, 2020, over 45,000 lessons have been consumed by employees across the globe.

Additionally, during our annual Compliance Week, employees logged over 4,300 training hours.

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.

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

Further, during our 2021 annual Compliance Week, employees logged over 6,000 training hours.

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

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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.

Finally, in response to COVID-19, we launched a series of virtual training programs and employee communications designed to support employees and leaders during a stressful transition to work at home, including programs on leading effective remote meetings, managing remotely and how to leverage collaborative learning tools.

Finally, we offer virtual training programs and employee communications designed to support employees and leaders that take advantage of our flexible work policy, including programs on leading effective remote meetings, managing remotely, and how to leverage collaborative learning tools.

Competitive Pay and Benefits

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Our wide-ranging benefits include:

health insurance, telehealth, prescription drug benefits, dental insurance, vision insurance, 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.

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;

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Health and Safety

The health and safety of our employees is a top priority.

Our safety focus is evident in our response to the COVID-19 pandemic around the globe, which includes the following:

• Creating a COVID-19 task force guided by several core principles, including protecting the health and safety of our employees and a COVID-19 response plan designed and guided by the World Health Organization, the Centers for Disease Control and Prevention, local governments, and health authorities and professionals;

• Adopting virtual on-boarding program for new employees and virtual customer training;

• Revising our flexible work policy to allow for greater work from home flexibility and providing equipment and tools to support remote work;

• Implementing health screening at our manufacturing facilities and corporate headquarters and enhanced cleaning procedures at all facilities;

• Providing meals for manufacturing employees to limit exposure and requiring manufacturing employees to quarantine for a period of time and produce two negative COVID-19 tests, if they travel to a “hotspot” location or attend a gathering where social distancing is not possible, before returning to the plant

• Providing 80 hours of COVID-19 paid sick time to all employees to use if they contract the virus or to care for family members and offering at-home COVID-19 testing to all U.S.

full-time, part-time, and temporary employees and contractors;

• Requiring health and safety protocols training and site specific training for all employees before being allowed to return to the office;

• Installing signage at all facilities to remind employees to wear a mask, wash hands, and social distance;

• Installing cubicle panel extensions at our corporate headquarters to further protect employees within their designated workstations and plexiglass in the cafeteria to allow for safe food delivery and dining;

• Providing personal protective equipment and cleaning supplies to each employee at all facilities, globally and to all field personnel.

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.

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.

Modern manufacturing enables efficiency and automation, which reduces exposure to health and safety risks throughout the production process.

At our facilities, the majority of our equipment is fully automated to minimize human involvement in the operations of machines and therefore reduce the risk of injury.

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.

Our programs and policies are in compliance with applicable local, regional, and federal laws, including U.S.

Occupational Safety and Health Administration requirements.

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.

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.

What changed 10-K

Item 1. Business