+Added: References within this Annual Report to “Tandem,” “we,” “our,” “us,” “management,” or the “Company” refer to Tandem Diabetes Care, Inc., together with its wholly-owned subsidiaries in the United States, Canada and the Netherlands.
We are a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes.
Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: Our goal is to lead in insulin therapy management across multiple of these market segments by providing a portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
+Added: Our goal is to lead in insulin therapy management across multiple of these market segments by providing a robust ecosystem and portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
Since our initial commercial launch, we have rapidly innovated and brought more products to market than our competitors.
−Removed: We have commercially launched seven insulin pump configurations in the United States since 2012 and three insulin pump configurations outside the United States since 2018.
−Removed: Today, our software-updatable t:slim X2 Insulin Delivery System (t:slim X2) hardware platform represents 100% of our new pump shipments.
−Removed: In the four-year period ended December 31, 2021, we shipped nearly 330,000 insulin pumps, which is representative of our estimated global installed customer base, assuming the typical four-year reimbursement cycle.
−Removed: Nearly 240,000 of these pumps were shipped to customers in the United States and nearly 90,000 were shipped to international markets.
+Added: Today, the t:slim X2 Insulin Delivery System (t:slim X2) is our flagship technology solution.
+Added: In the four-year period ended December 31, 2022, we shipped approximately 420,000 t:slim X2 insulin pumps, which is representative of our estimated global installed customer base, assuming the typical four-year reimbursement cycle.
+Added: Approximately 290,000 of these pumps were shipped to customers in the United States and 130,000 were shipped to customers outside the United States.
+Added: Our products are currently available in approximately 25 countries outside the United States.
Our manufacturing, sales and support activities principally focus on our flagship pump platform, the t:slim X2 and our complementary product offerings.
Our simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available in the United States.
−Removed: We have commercially offered two different automated insulin dosing (AID) algorithms on t:slim X2, including our Control-IQ technology, which is an advanced hybrid-closed loop feature, designed to help increase a user's time in their targeted glycemic range.
+Added: The majority of our customers use the t:slim X2 with continuous glucose monitoring (CGM) integration.
+Added: This allows the t:slim X2 to receive CGM sensor readings, which can then be used in our automated insulin dosing (AID) algorithms, including our Control-IQ technology.
+Added: Control-IQ is an advanced hybrid-closed loop feature designed to help increase a user's time in their targeted glycemic range.
+Added: Multiple studies have demonstrated that use of Control-IQ technology provides people across all demographics with improved clinical outcomes that are both immediate and sustained.
It was the first system cleared by the U.S.
−Removed: Food and Drug Administration (FDA) to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar based on continuous glucose monitoring (CGM) readings.
−Removed: Approximately 200,000 t:slim X2 users have our Control-IQ technology, which launched in the United States in the first quarter of 2020, and is now available in more than 20 countries.
−Removed: Our Control-IQ technology uses information from Dexcom Inc.’s (Dexcom) G6 sensor, which is the third generation of Dexcom CGM that we have integrated with our pump technology.
+Added: Food and Drug Administration (FDA) to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.
The t:slim X2 is unique in that it is the only pump on which remote software updates have been made commercially available in the United States.
−Removed: Now available in the countries we serve worldwide, our Tandem Device Updater (TDU), is a revolutionary tool that has allowed more than 130,000 people to update their t:slim X2 software from a personal computer.
−Removed: This offering is a competitive advantage as it allows us to bring new features, such as our AID technology and CGM integration, to our customers faster than the industry has been able to historically.
+Added: Now available in the countries we serve worldwide, our Tandem Device Updater (TDU) that has allowed approximately 200,000 people to update their t:slim X2 software from a personal computer.
+Added: This offering is a competitive advantage that allows us to bring our customers clinical and lifestyle enhancements, such as new developments in our AID technology, CGM integrations and mobile app features.
+Added: In July 2022, we launched a new pump software update through TDU to allow all t:slim X2 pump users in the United States to bolus insulin using our smartphone app that is available on compatible iOS and Android devices.
Our insulin pump products are generally considered durable medical equipment and have an expected lifespan of at least four years.
In addition to insulin pumps, we sell disposable products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.
−Removed: Additionally, we sell accessories such as belt clips and cases for use with pumps which are designed to enhance usability.
In the United States, we also offer t:connect, our data management web application that provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
−Removed: Our primary research and development and administrative headquarters are located in San Diego, California.
−Removed: We also operate a manufacturing facility and a warehousing facility in San Diego.
−Removed: In addition, we maintain offices in Boise, Idaho and in Markham, Ontario, Canada.
−Removed: We employed approximately 2,000 regular full-time employees as of December 31, 2021.
+Added: We are focused on developing diabetes solutions that expand our portfolio of insulin pump offerings, provide even greater personalization to our AID algorithms, expand our AID indications, and that further improve the user experience with our diabetes management systems, data product offerings and services we provide.
Diabetes and the Insulin Therapy Management Market
Diabetes is a chronic, life-threatening disease for which there is no known cure.
−Removed: The disease is categorized by improper function of the pancreas when it either does not produce enough insulin or the body cannot effectively use the insulin it produces.
−Removed: If not closely monitored and properly treated, diabetes can lead to serious medical complications, including damage to various tissues and organs, seizures, coma and death.
Diabetes is typically classified as either type 1 or type 2:
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Individuals with type 1 diabetes require intensive insulin therapy to survive.
−Removed: • Type 2 diabetes represents 90% to 95% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce enough insulin.
−Removed: Initially, many people with type 2 diabetes often attempt to manage their diabetes with improvements in diet and exercise, and with oral medications.
−Removed: However, as their diabetes advances, many patients progress to requiring injectable therapies, such as long-acting insulin, and a subset of this population require intensive insulin therapy.
−Removed: The International Diabetes Federation estimates that, in 2021, approximately 297 million adults age 20-79 years worldwide had diagnosed type 1 or 2 diabetes.
−Removed: In addition, approximately 1.2 million children and adolescents had type 1 diabetes, and nearly 150,000 people under age 20 are estimated to be diagnosed annually.
−Removed: In the United States, the Centers for Disease Control and Prevention estimates that in 2021 approximately 37.3 million people were living with diabetes of which approximately 28.5 million had diagnosed diabetes.
+Added: • Type 2 diabetes represents 90% to 95% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly use insulin or produce enough insulin.
+Added: It’s a progressive condition, and a person in the advanced stages of living with type 2 diabetes often requires intensive insulin therapy.
We consider our addressable market to be people diagnosed with diabetes who are living with either type 1 diabetes, or with type 2 diabetes who require intensive insulin therapy.
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Type 2 (all therapies) 267.3 million 26.9 million
−Removed: Type 2 (insulin only) 10 million 2 million
+Added: Type 2 (insulin-dependent) 10 million 2 million
(1) Internal estimates based on data from the International Diabetes Federation and the Centers for Disease Control and Prevention (CDC)
−Removed: Diabetes Management Challenges
+Added: Diabetes Management
Diabetes can be difficult for patients to manage.
Unlike most therapies, insulin requirements can vary greatly and can be affected by many factors, such as type or quantity of food eaten, illness, stress and exercise.
−Removed: People with diabetes have to be diligent in working to prevent their blood glucose from fluctuating outside of a targeted range.
−Removed: Hypoglycemia, or low blood glucose levels, can cause a variety of long-term effects or complications, including damage to various tissues and organs, seizures, coma or death.
−Removed: Hyperglycemia, or high blood glucose levels, can also cause a variety of long-term effects or complications, including cardiovascular disease and damage to various tissues and organs.
−Removed: Preventing and managing fluctuations in blood glucose levels, particularly when someone is outside their target blood glucose range is often time consuming and stressful to people with diabetes and their loved ones.
−Removed: Insulin Therapy Management
−Removed: There are two primary therapies used by people with insulin-dependent diabetes, insulin injections and insulin pumps.
−Removed: The use of insulin injections is often referred to as Multiple Daily Injection (MDI) therapy.
+Added: Preventing and managing fluctuations in blood glucose levels between hypoglycemia, or low blood glucose levels, and hyperglycemia, or high blood glucose levels, is often time consuming and stressful to people with diabetes and their loved ones.
+Added: There are two primary therapies used by people with insulin-dependent diabetes, Multiple Daily Injection (MDI) and insulin pumps.
Insulin pumps are intended to more closely resemble the physiologic function of a healthy pancreas and use rapid-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements.
−Removed: Insulin pump systems are most commonly comprised of a programmable hardware device, a cartridge filled with insulin by the user, and an infusion set to administer insulin into the person’s body.
−Removed: This system is known as a durable pump.
−Removed: By comparison, patch insulin pumps are disposable and adhere to the body without an infusion set.
+Added: Insulin pump systems are most commonly comprised of a programmable, durable device, a disposable cartridge filled with insulin by the user, and a disposable infusion set to administer insulin into the person’s body.
+Added: This system is typically known as a durable pump and the device itself is expected to last for multiple years.
+Added: By comparison, there are also disposable pumps which combine the pump mechanism, battery and electronics with the cartridge and infusion set into a body-worn patch.
+Added: These pumps are entirely disposed of by the user every 3-days.
+Added: More than 1 million people worldwide are estimated to use an insulin pump to manage their diabetes.
+Added: We estimate that 750,000 people in the United States use an insulin pump.
+Added: In addition, we estimate that approximately 450,000 people use an insulin pump in approximately 25 countries outside the United States in which our insulin pump is available.
Insulin pump therapy can provide benefit to a person with insulin-dependent diabetes when used independently or in conjunction with CGM, which is a therapy that provides users with real-time access to their glucose levels as well as trend information.
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Insulin pumps may also feature connectivity with mobile apps and data management applications, which are used by the pump user, their caregivers and their healthcare providers, to quickly and easily identify meaningful insights and trends, allowing them to refine therapy and lifestyle choices for better management of their diabetes.
−Removed: More than 1 million people worldwide are estimated to use an insulin pump to manage their diabetes.
−Removed: We estimate that 750,000 people in the United States use an insulin pump.
−Removed: In addition, we estimate that approximately 450,000 people use an insulin pump in the more than 20 countries outside the United States in which our insulin pump is available.
−Removed: There are a variety of insulin pump manufacturers worldwide, while in the United States, we are currently one of only two commercial durable insulin pump manufacturers and there is one programmable commercial patch insulin pump manufacturer.
−Removed: We believe that the distinct advantages and increased awareness of insulin pump therapy as compared to other available insulin therapies will continue to generate demand for insulin pump devices and pump-related supplies.
−Removed: We further 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.
Our Technology:
−Removed: Improving the Lives of People with Diabetes
+Added: Improving the Lives of People with Insulin-Dependent Diabetes
We develop our insulin pump technology and related product offerings using a consumer-focused approach.
We initially rely on the use of behavioral sciences, including extensive research to ascertain what people with insulin-dependent diabetes require and prefer from their diabetes therapy.
−Removed: We then look to modern consumer technology for inspiration and design our hardware and software solutions to meet the specific demands of people with diabetes.
+Added: We then look to modern consumer technology for inspiration and design our hardware and software solutions to meet the specific demands of people living with diabetes.
This multi-step approach has resulted in products that provide users with the distinct features and functionality they seek and in a manner that makes the features usable and intuitive.
Since our initial commercial launch, we have been able to rapidly innovate and bring more products to market than our competitors.
−Removed: We have commercially launched seven insulin pump configurations since inception, all of which have been developed using our proprietary technology platform.
The following table provides information regarding the commercial availability of our insulin pump products:
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*Scaled launch based on the timing of regulatory approvals and other factors.
−Removed: Today, our commercial efforts exclusively focus on the manufacturing, sale and support of our flagship pump platform, the t:slim X2 insulin delivery system, but we continue to provide ongoing service and support to existing t:slim, t:slim G4 and t:flex customers.
+Added: Today, our commercial efforts exclusively focus on the manufacturing, sale and support of our flagship pump platform, the t:slim X2 insulin delivery system.
The t:slim X2 insulin delivery system is comprised of a t:slim X2 pump, its 300-unit disposable insulin cartridge and an infusion set.
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t:slim X2 Profile (Actual Size)
−Removed: • Flexible technology - The device can be used with or without AID or CGM.
−Removed: When advanced features are turned off, the t:slim X2 pump removes the CGM chart from the screen and puts the Bolus and Option buttons front and center for easy access.
−Removed: • AID features - We have commercially launched two AID algorithms on our t:slim X2 platform:
−Removed: Basal-IQ technology and Control-IQ technology.
−Removed: ◦ Basal-IQ technology:
−Removed: This predictive low glucose suspend feature is designed to temporarily suspend insulin delivery to help reduce the frequency and duration of hypoglycemic events.
−Removed: With Dexcom G6 CGM integration, this feature works with no fingersticks required for mealtime dosing or calibration.
−Removed: ◦ Control-IQ technology:
−Removed: This advanced hybrid-closed loop feature is designed to help increase a user's time in targeted glycemic range (70-180 mg/dL).
−Removed: Approximately 200,000 t:slim X2 users worldwide have our Control-IQ technology.
+Added: • Control-IQ advanced hybrid-closed loop technology:
+Added: This AID feature is designed to help increase a user's time in targeted glycemic range (70-180 mg/dL), and is used by the majority of our customers worldwide.
Control-IQ was the first AID algorithm cleared by the FDA to deliver automatic correction boluses in addition to adjusting basal insulin to help prevent high and low blood sugar.
−Removed: Control-IQ technology is integrated with Dexcom’s G6 CGM and offers optional settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.
+Added: Control-IQ technology offers optional settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.
Results from two independent pivotal studies using Control-IQ technology were published in the New England Journal of Medicine in October 2019 and August 2020.
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Tandem Device Updater
−Removed: A tool that allows pump users to update their pumps’ software quickly and easily from a personal computer.
+Added: This tool allows pump users to update their pump software quickly and easily from a personal computer.
It is PC- and Mac- compatible and designed to work with the t:slim X2 in a manner similar to software updates on a smartphone.
−Removed: We have used this technology to offer in-warranty t:slim customers in the United States four different software updates for no-cost, most recently including our Control-IQ technology.
+Added: We have used this technology to offer t:slim X2 customers in the United States multiple different software updates for no-cost.
Outside the United States we began offering no-cost software updates for Basal-IQ technology in the third quarter of 2019 and Control-IQ technology updates in the third quarter of 2020.
Our web-based data management application provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
−Removed: This application empowers people with diabetes, as well as their caregivers and healthcare providers, to quickly and easily identify meaningful insights and trends, allowing them to refine therapy and lifestyle choices for better management of their diabetes.
−Removed: It also provides us with valuable data that we can analyze computationally to reveal patterns, trends and associations that can be used in continuous product improvements and in the identification of clinical outcomes data.
−Removed: t:connect launched in the United States in the third quarter of 2013.
−Removed: In 2017, we launched t:connect HCP, which is an enhanced version of t:connect designed to simplify the ability of pump users to share t:connect data with their healthcare providers.
+Added: It also provides us with valuable data that we can analyze computationally to reveal patterns, trends and associations that can be used in continuous product improvements and in the analysis of clinical outcomes data.
In the third quarter of 2020, we launched the t:connect mobile application that features the wireless upload of pump data to t:connect, allows the user to receive notification of pump alerts and alarms, and provide a discrete, secondary display of glucose and insulin data.
−Removed: The t:connect mobile application is compatible with multiple versions of iOS and Android operating systems, and at the end of 2021, approximately 180,000 customers had downloaded our mobile app.
+Added: The t:connect mobile application is compatible with multiple versions of iOS and Android operating systems, and as of the end of 2022, there were approximately 300,000 downloads of our t:connect mobile app.
We believe t:connect (web data management and mobile app) can serve as key components of additional health applications and services that are currently under development.
−Removed: During the second quarter of 2020, we acquired Sugarmate, Inc.
−Removed: (Sugarmate), the developer of a popular mobile app for people with diabetes who use insulin.
−Removed: The Sugarmate app is designed to help people with diabetes visualize diabetes therapy data in innovative ways.
+Added: Sugarmate is a popular mobile app that is designed to help people visualize diabetes therapy data in innovative ways.
It allows users to log glucose data and health and nutrition information, and can provide notifications and alerts to users, their family, and their caregivers.
−Removed: Sugarmate became a wholly owned subsidiary of Tandem, and is continuing to be led by its founder, who joined our Company.
+Added: Our Strategy & Products Under Development
Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: Our goal is to lead in insulin therapy management by providing a portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
−Removed: We believe that our positively different approach uniquely positions us to significantly expand and further penetrate the varying segments of the intensive insulin using diabetes market by focusing on the needs of our customers and their caregivers, and by supporting healthcare providers and payors with real world insights.
−Removed: To achieve our goal, we intend to pursue the following business strategies:
−Removed: • drive worldwide adoption of our products by offering the best insulin delivery systems;
−Removed: • deliver a portfolio of therapy management solutions designed to improve patient outcomes;
−Removed: • expand the value provided by our portfolio through an ecosystem approach to diabetes management;
−Removed: • build deeper relationships with all stakeholders across multiple channels, including virtual and telehealth platforms;
−Removed: • leverage our manufacturing operations to achieve cost and production efficiencies;
−Removed: • use data in new ways that deliver real-world insights and that promote better outcomes;
−Removed: • identify new offerings that support our mission to improve the lives of people with diabetes.
−Removed: Products Under Development
−Removed: Our products under development support our strategy of developing insulin delivery systems as part of a therapy management portfolio that is designed to improve patient experience and outcomes.
−Removed: Our product development efforts fall into three pillars of innovation:
+Added: Our goal is to lead in insulin therapy management across multiple market segments by providing a portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
+Added: We believe our positively different approach to diabetes management uniquely positions us to significantly expand and further penetrate the varying segments of the intensive insulin using diabetes market by focusing on the needs of our customers and their caregivers, and by supporting healthcare providers and payors with real world insights.
+Added: In support of this strategy, our product development efforts fall into three pillars of innovation:
delivery devices, device software including algorithms, and data and insights.
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Preferences in the size, shape, and mode of operation that comprise an insulin pump’s hardware often impact a person’s pump purchasing decision and overall user experience.
−Removed: Formerly referred to under its development name, t:sport, the Tandem Mobi is approximately half the size of our t:slim X2 pump, and is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump.
−Removed: Its features include a 200-unit cartridge, an on-pump bolus button, inductive charging, an AID algorithm, and is waterproof.
−Removed: We anticipate that Mobi will be our first insulin pump to support full pump-control from our mobile application.
+Added: The Tandem Mobi is approximately half the size of our t:slim X2 pump, and is designed for people who seek even greater discretion and flexibility with the use of their insulin pump.
+Added: Its features include full pump-control from our mobile application, a 200-unit cartridge, an on-pump bolus button, inductive charging, and an AID algorithm.
Advancing our flagship t:slim platform, the t:slim X3 is being designed to provide a modernized user interface and even greater usability for our planned feature updates.
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This offering is being developed to provide an alternative tubeless infusion site option for Mobi pump users.
−Removed: A goal of this design is to allow for people living with diabetes to customize the way they wear their pump with each cartridge change to best suit their personal preferences and lifestyle.
−Removed: Our patch pump design is in its early stages and is being developed for people living with diabetes who want a disposable tubeless solution.
+Added: It will allow a Mobi pump to be worn completely on the user’s body with no tubing.
+Added: A goal of this design is to allow people living with diabetes to customize the way they wear their pump with each cartridge change, switching between tubed and tubeless wear configurations, to best suit their personal preferences and lifestyle .
+Added: This ergonomic, rechargeable patch pump is being designed to reduce the burden of managing diabetes through its use of pre-filled insulin cartridges and compatibility with AID technology.
+Added: This replaces our early-stage development of a disposable tubeless solution that was previously under development.
+Added: Extended Wear Infusion Sets
+Added: Infusion sets provide additional choice and flexibility to people living with diabetes.
+Added: Our goals for infusion set innovations focus on solutions that extend wear time and enhance user experience, while reducing occlusions, body burden and waste.
+Added: In support of this effort, we are currently developing unique extended wear infusion set technology.
Device Software
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It also includes our AID technology, and the software used to support remote pump updatability.
−Removed: Control-IQ Technology Advancements
−Removed: We are driving innovation in our algorithms, emphasizing automation, personalization and simplification, all intended to continue to improve therapeutic outcomes and provide a positive patient experience characterized by simplicity and ease of use.
−Removed: Additionally, we have initiated clinical studies to expand the indications of our Control-IQ technology to include people with type 1 diabetes ages 2 to 5 years old, as well as people living with type 2 diabetes.
+Added: Control-IQ Advancements
+Added: We are continuing to drive innovation in our algorithms, emphasizing automation, personalization and simplification to continue to improve therapeutic outcomes and provide a positive patient experience.
+Added: We have recently completed clinical studies to support expanding the indications of our Control-IQ technology to include people with type 1 diabetes ages 2 to 5 years old.
+Added: Additionally, we are initiating a pivotal study to support expanding indications to include people living with type 2 diabetes.
We are also researching the use of different insulins with our Control-IQ technology.
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Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complementary system components.
−Removed: In November 2020, we entered into an agreement with Dexcom to extend our current collaboration to include integration with their future G7 CGM technology.
−Removed: Following integrated product development work, and required regulatory clearances or approvals, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices.
−Removed: In June 2020, we announced an agreement with Abbott Laboratories (Abbott), to develop and commercialize integrated diabetes solutions that combine Abbott’s CGM technology with our insulin delivery systems.
+Added: We have agreements with Dexcom to extend our current collaboration to include integration with their G7 CGM technology.
+Added: Following integrated product development work, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices.
+Added: We have an agreement with Abbott Laboratories (Abbott), to develop and commercialize integrated diabetes solutions that combine Abbott’s FreeStyle Libre CGM technology with our insulin delivery systems.
Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S.
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Our goal is to innovate across our digital health platforms by using the vast amount of data that we collect, in combination with technology such as artificial intelligence or machine learning, to provide information and insights to people living with diabetes, their caregivers and healthcare providers and insurance payors.
−Removed: Key areas of development include making these insights easy to understand, provided in a flexible format with mobile or web apps, and available real time.
−Removed: In addition, we are working to integrate health-related information from third-party sources and use our data to support current and future products under development.
+Added: Our key objectives include making these insights easy to understand, making the data available in real time, and providing the information in a flexible format with mobile or web apps.
+Added: In addition, we are working to integrate health-related information from third-party sources and to use our data to support current and future products under development.
Tandem Source
−Removed: Expanding the capabilities of our t:connect data management application available for customers in the United States, Tandem Source is our second-generation web-based data management application that is being designed to become our single, global platform.
−Removed: This application enhances clinical data visualization, provides added interface customization for users to personalize how they engage with their data and for healthcare providers to better manage their care.
−Removed: In the second quarter of 2021, we began limited testing of an initial version of Tandem Source in the United Kingdom.
+Added: Expanding the capabilities of our t:connect data management application available for customers in the United States, Tandem Source is our second-generation web-based data management application that is being designed to be deployed globally.
+Added: This application enhances clinical data visualization, and provides added interface customization for users to personalize how they engage with their data and for healthcare providers to better manage their care.
We continue to develop and test new features for Tandem Source in anticipation of a future commercial release of the product.
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In support of this effort, we are working to automate our pump settings adjustments to further enhance ease of use and expand adoption of our insulin pump products.
−Removed: Sales, Marketing and Customer Care
−Removed: In 2021, our U.S.
−Removed: sales organization was comprised of approximately 95 territories, which we began expanding to approximately 110 territories at the end of the year.
−Removed: The vast majority of these territories are supported by a sales representative and a clinical diabetes specialist who, as a team, call on endocrinologists, nurse practitioners, primary care physicians, certified diabetes educators and potential customers.
−Removed: Where appropriate, some territories are supported by multiple clinical diabetes specialists.
−Removed: sales team is augmented by individuals in our internal customer sales support organization, who follow up on leads generated through promotional activities and educate people on the benefits of our proprietary technology and products.
−Removed: Our internal customer sales support organization also contacts existing customers who are approaching their insurance renewal date to aid in the renewal process.
−Removed: Typically, customers are eligible for insurance reimbursement to purchase a new insulin pump once every four years;
−Removed: however, some plans may be limited to once every five years or have additional restrictions or requirements.
−Removed: Insurance reimbursement processes outside the United States vary by geography.
−Removed: In Canada, we established a small direct sales and clinical infrastructure in 2018, and since that time have secured reimbursement in the majority of Canadian provinces.
−Removed: We commenced marketing and sales efforts of the t:slim X2 with G5 integration in the fourth quarter of 2018, for the t:slim X2 with Basal-IQ technology in the fourth quarter of 2019, and for the t:slim X2 with Control-IQ technology in the first quarter of 2021.
−Removed: In more than 20 countries outside the United States, we have contracted with distributors who have substantial responsibility for sales, marketing and customer support efforts.
−Removed: We began our scaled launch outside the United States in the third quarter of 2018 after obtaining the right to affix the CE Mark to the t:slim X2 with G5 integration, followed by the scaled launches of our Basal-IQ technology and Control-IQ technology in the third quarter of 2019 and 2020, respectively.
+Added: Markets and Distribution Methods
+Added: The t:slim X2 insulin delivery system is now available in approximately 25 countries worldwide.
+Added: In the United States and Canada, we employ a direct sales and clinical organization.
+Added: This organization is augmented by individuals in our internal customer sales support organization, who follow up with existing customers who are approaching their insurance renewal date to aid in the renewal process and on leads generated through promotional activities.
+Added: Outside the United States, we have contracted with distributors who have substantial responsibility for sales, marketing and customer support efforts.
Revenue Concentrations and Significant Customers.
A small number of independent distributors in the United States have historically accounted for a significant portion of our revenues.
−Removed: During the year ended December 31, 2021, we made sales to approximately 44 independent distributors in the United States, and 16 independent distributors internationally.
−Removed: During the year ended December 31, 2021, sales to our two largest distributors accounted for a combined 21.5% of consolidated sales.
−Removed: During the year ended December 31, 2020, sales to our two largest distributors accounted for a combined 28.8% of consolidated sales.
−Removed: None of our independent distributors in the United States are required to sell our products exclusively and each of them may freely sell the products of our competitors.
−Removed: Our distributor agreements in the United States generally have one-year initial terms with automatic one-year renewal terms and are terminable in connection with a party’s material breach.
−Removed: Our distributor agreements outside the United States generally have longer initial terms and, in addition to being terminable in connection with a party’s material breach, include provisions that allow us to terminate those agreements prior to their ordinary expiration in exceptional circumstances.
−Removed: We believe our domestic distributors carry minimal inventory at any given time.
−Removed: Internationally, there may be variability in inventory levels among our distributors, particularly when they first commence product sales or surrounding the launch of new products.
+Added: Generally, our five largest distributors account for approximately 40% of consolidated sales.
+Added: We believe our distributors in the United States carry minimal inventory at any given time.
+Added: Outside the United States, there may be variability in inventory levels among our distributors, particularly when they first commence product sales or surrounding the launch of new products.
Training and Customer Care .
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We also provide training and technical services to our distribution partners who fulfill their customer care responsibilities outside the United States.
−Removed: Our goal is to offer the highest level of customer support and services as these offerings are often viewed by people with diabetes and their healthcare providers as being equally as important as the products we offer.
Third-Party Reimbursement
−Removed: In the United States, customer orders are typically fulfilled by billing third-party payors on behalf of our customers, or by utilizing our network of distributors who then bill third-party payors on our customers’ behalf.
−Removed: Our fulfillment and reimbursement systems are fully integrated such that our products are shipped only after receipt of a valid physician’s order and verification of current health insurance information.
+Added: In the United States, customer orders are typically fulfilled by billing third-party payors on behalf of our customers, or by using our network of distributors who then bill third-party payors on our customers’ behalf.
+Added: Typically, customers are eligible for insurance reimbursement for the purchase of a new insulin pump once every four years.
+Added: However, some plans may be limited to once every five years or have additional restrictions or requirements.
+Added: Insurance reimbursement processes outside the United States vary by geography.
We are accredited by the Community Health Accreditation Program and are an approved Medicare provider.
−Removed: Over the last ten years, Medicare reimbursement rates for insulin pumps and disposable insulin cartridges have increased modestly.
−Removed: In the United States, we primarily bill for our insulin pump products and associated supplies using existing Healthcare Common Procedure Coding System codes for which Medicare reimbursement is well established.
−Removed: However, pump eligibility criteria for people with type 2 diabetes can be different and may require additional documentation and laboratory testing to gain in-network insurance reimbursement benefits.
We enter into contracts with national and regional third-party payors to establish reimbursement for our insulin pump products, disposable insulin cartridges and other related supplies.
−Removed: We employ a team of managed care managers who are responsible for negotiating and securing contracts with third-party payors throughout the United States.
−Removed: If we are not contracted with a prospective customer’s third-party payor and in-network status cannot be otherwise obtained, then to the extent possible we utilize distribution channels so our customers’ orders can be serviced.
−Removed: For the year ended December 31, 2021, approximately 34% of our sales in the United States were generated through our direct third-party payor contracts, compared to approximately 30% for the same period of 2020.
−Removed: As of December 31, 2021, our distribution channel was comprised of approximately 44 independent distributors.
−Removed: In most cases, but not all, our network of distributors allows us access to prospective customers who are covered by commercial payors with whom we are not contracted, at in-network rates that are generally more affordable for our customers.
−Removed: The most significant exception was in the period from July 2016 to June 2020.
−Removed: During that time, only a small subset of UnitedHealthcare’s members were able to obtain reimbursement for our products through our direct or distribution channels, primarily select pediatric and government plan members.
−Removed: In July 2020, we were named as a network provider by UnitedHealthcare.
−Removed: Our distribution partners outside the United States and Canada are responsible for all reimbursement, tender application and fulfillment activities.
+Added: If we are not contracted with a prospective customer’s third-party payor and in-network status cannot be otherwise obtained, then to the extent possible we use distribution channels so our customers’ orders can be serviced.
+Added: While we have been working to increase our sales in the United States through our direct third-party payor contracts, the percentage is currently less than half of total sales.
+Added: Outside of the United States and Canada, our distribution partners are responsible for all reimbursement, tender application and fulfillment activities.
Manufacturing and Quality Assurance
Our pump products are currently assembled, tested and packaged at our facilities in San Diego, California.
−Removed: Prior to 2020, we manufactured and tested our disposable cartridge products at our Barnes Canyon facility in San Diego, California.
−Removed: Since that time, we have transferred a substantial portion of our cartridge manufacturing and testing to an experienced third-party contract manufacturer to provide us additional flexibility in scaling our business while creating additional leverage.
−Removed: We also utilize external third parties for sterilization of our finished cartridges.
+Added: Over the course of the last two years, we have been transitioning our t:slim cartridge manufacturing to an experienced third-party contract manufacturer to provide us additional flexibility in scaling our business while creating additional leverage.
+Added: We also use external third parties to sterilize our finished cartridges.
All finished cartridges are packaged for sale at our facilities in San Diego.
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Members of our quality department also inspect our devices at various steps during the manufacturing cycle to facilitate compliance with our devices’ stringent specifications.
−Removed: We follow and comply with a comprehensive set of quality certifications and standards.
−Removed: For example, in the product development process, we follow standards such as IEC 62304:2006, the international consensus for medical device software lifecycle processes, ISO 14971:2019 for the application of risk management to medical devices, and IEC 60601 which is a series of technical standards regarding the basic safety and essential performance of medical electrical equipment.
−Removed: In addition, we have built and maintain our quality management system to comply with the FDA’s Code of Federal Regulations Title 21 CFR Parts 820, 806, 803 and 11, ISO 13485 and 14971, as well as any other country-specific requirement where Tandem products are distributed.
We have received certification from BSI Group, a Notified Body to the International Standards Organization (ISO), of our quality system.
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As a medical device manufacturer, our manufacturing facility and the facilities of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and certain corresponding state agencies.
−Removed: Research and Development
−Removed: Our research and development team includes employees with specialist experience across diverse engineering disciplines and user experience design, many of whom have considerable experience developing diabetes-related products.
−Removed: Our research and development team focuses on the continuous improvement and support of current product offerings, as well as our products under development.
−Removed: In June 2015, we entered into non-exclusive agreements with DexCom to allow the integration of our insulin pump products with the DexCom G5 and G6 CGM systems worldwide.
−Removed: In November 2020, we entered into non-exclusive agreements with DexCom to continue the development and collaboration activities that enable the integration of the Company’s insulin pump products with DexCom’s CGM devices, including current and future generation insulin pump products with DexCom’s G6 and G7 CGM devices.
−Removed: The 2015 agreements had an initial term of five years, and thereafter renew automatically for additional one-year terms unless either party provides advance notice to the other party that they do not wish to extend the agreements.
−Removed: The 2020 agreements have an initial term of five years and thereafter renew automatically for additional successive two-year periods unless either party provides advance notice of non-renewal.
−Removed: The agreements do not require any licensing fees, milestone payments or royalty obligations to DexCom.
−Removed: The agreements contain customary provisions for termination in the event of an uncured material breach or in the event of a dissolution of the other party, and prohibit our assignment of the agreements to a DexCom competitor without DexCom’s prior consent.
−Removed: In 2016, we entered into a worldwide, non-exclusive, royalty-bearing license agreement with TypeZero to allow the integration of our insulin pump products with TypeZero’s inControl AID technology.
−Removed: The agreement also provides us access to TypeZero’s future AID innovations for five years following the date of the agreement.
−Removed: In addition, the license agreement contemplated that our insulin pump products would be used alongside TypeZero’s AID technology in certain studies under the International Diabetes Closed Loop (IDCL) Trial, which are now completed.
−Removed: In August 2018, TypeZero was acquired by Dexcom.
−Removed: Nevertheless, the terms of our agreement with TypeZero remain effective until the patents covered by the agreement have expired, subject to customary provisions for termination in the event of an uncured material breach.
−Removed: In June 2020 we announced an agreement with Abbott to develop and commercialize integrated diabetes solutions that combine Abbott’s CGM technology with our insulin delivery systems to provide more options for people to manage their diabetes.
−Removed: Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S.
−Removed: and Canada, and consider additional geographies in the future.
Intellectual Property
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We rely on a combination of copyright, patent, trademark, trade secret and other intellectual property laws, non-disclosure agreements and other measures to protect our proprietary rights.
−Removed: As of December 31, 2021, our patent portfolio consisted of approximately 117 issued U.S.
−Removed: patents and 83 pending U.S.
−Removed: patent applications.
−Removed: Of these, our issued U.S.
−Removed: patents expire between approximately 2022 and 2040.
−Removed: Our foreign patent portfolio consisted of approximately 41 issued patents and 15 pending patent applications in other countries throughout the world.
−Removed: Of these, our issued foreign patents expire between approximately 2025 and 2036.
−Removed: In addition, we also have 94 trademark registrations, including 18 U.S.
−Removed: trademark registrations and 76 foreign trademark registrations.
−Removed: In July 2012, we entered into an agreement with Smiths Medical, Inc.
−Removed: pursuant to which we were granted, through certain assignments and certain non-exclusive and exclusive, worldwide, fully paid-up, royalty-free licenses, certain rights to patents and patent applications related to ambulatory infusion pumps and related software and accessories for the treatment of diabetes.
−Removed: In July 2020, we entered into a non-exclusive patent cross-license agreement for certain technologies in the field of diabetes with Medtronic plc (Medtronic).
−Removed: With certain exclusions, the agreement applies to the companies’ existing products, as well as new products for at least the next five years, and includes a provision that prohibits the parties from cloning one another’s products.
+Added: As of December 31, 2022, our patent portfolio includes numerous issued patents and pending patent applications in the U.S.
+Added: and other countries, which in the aggregate, we believe to be important to our business.
+Added: Patents are generally effective for 20 years from the date the earliest application was filed, and in some cases may be extended.
+Added: Our issued patents as of December 31, 2022 are set to expire over a range of years, from 2024 to 2041, subject to any extensions.
+Added: We also have various registered U.S.
+Added: trademarks, registered European Community trademarks, and other trademark registrations and pending trademark applications in other countries and regions of the world.
+Added: In addition, we have entered into exclusive and non-exclusive licenses in the ordinary course of business relating to a wide array of technologies or other intellectual property rights or assets.
The medical device industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products, treatment techniques or technologies, or other market activities of industry participants.
−Removed: We compete in markets worldwide with a number of companies that manufacture insulin delivery devices, such as Medtronic MiniMed, a division of Medtronic, and Insulet Corporation (Insulet).
−Removed: In addition, Eli Lilly & Co.
−Removed: (Eli Lilly) announced a collaboration to commercialize a version of Ypsomed AG’s existing insulin pump as part of a to-be-developed system and Becton Dickinson and Company announced its intention to spin off its diabetes care business as a separate publicly-traded company.
+Added: We compete in markets worldwide with two primary companies that manufacture insulin delivery devices.
There are also a number of other companies developing and marketing their own insulin delivery systems and/or related software applications for launch in the U.S.
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In addition, we face competition from a number of companies, medical researchers and existing pharmaceutical companies that are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and prevention of diabetes.
−Removed: For additional information, see the section of this Annual Report under the caption “Risk Factors” in Part I, Item 1A.
Government Regulation
Our products are medical devices subject to extensive regulation by the FDA in the United States, corresponding state regulatory authorities and other regulatory bodies in other countries.
−Removed: Federal Food, Drug, and Cosmetic Act, (FDCA) and the FDA’s implementing regulations govern:
−Removed: • product design and development;
−Removed: • pre-clinical and clinical testing;
−Removed: • establishment registration and product listing;
−Removed: • product manufacturing;
−Removed: • labeling and storage;
−Removed: • pre-market clearance or approval;
−Removed: • advertising and promotion;
−Removed: • product sales and distribution;
−Removed: • recalls and field safety corrective actions;
−Removed: • servicing and post-market surveillance.
−Removed: FDA’s Pre-Market Clearance and Approval Requirements.
−Removed: Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a pre-market notification under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA through the premarket approval (PMA), process.
−Removed: Both the 510(k) clearance and PMA processes can be expensive, lengthy and require payment of significant user fees, unless an exemption is available.
−Removed: The FDA classifies medical devices into one of three classes.
−Removed: Devices requiring fewer controls because they are deemed to pose lower risk are placed in Class I or II.
−Removed: Class I devices are subject to general controls such as labeling, pre-market notification and adherence to the FDA’s Quality System Regulation (QSR), which cover manufacturers’ methods and documentation of the design, testing, production, control quality assurance, labeling, packaging, sterilization, storage and shipping of products.
−Removed: Class II devices are subject to special controls such as performance standards, post-market surveillance, FDA guidelines, or particularized labeling, as well as general controls.
−Removed: Some Class I and Class II devices are exempted by regulation from the 510(k) clearance requirement, and the requirement of compliance with substantially all of the QSR.
−Removed: t:slim, t:flex, t:slim X2, t:slim X2 with Control-IQ technology and t:connect received FDA clearance as Class II devices.
−Removed: However, t:connect was subsequently down-classified to a Class I device.
−Removed: A PMA application is required for devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices, or those that are “not substantially equivalent” either to a device previously cleared through the 510(k) process or to a “preamendment” Class III device in commercial distribution before May 28, 1976 when PMA applications were not required.
−Removed: t:slim G4, t:slim X2 with G5 integration and t:slim X2 with Basal-IQ technology received FDA approval as Class III devices.
−Removed: There are three new Class II categories classified by the FDA for the interoperability of devices as a complete AID system that are intended to help support continued rapid innovation by streamlining the regulatory pathway for integrated products approved by the FDA.
+Added: Each new or significantly modified medical device we seek to commercially distribute in the United States will require either a pre-market notification under Section 510(k) of the U.S.
+Added: Federal Food, Drug and Cosmetic Act (FDCA), also referred to as a 510(k) clearance, or approval from the FDA through the premarket approval (PMA) process.
+Added: We have obtained clearance on multiple devices in both Class II and Class III, including Control IQ and the tslim:X2.
+Added: 510(k) Clearance .
+Added: 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.
+Added: 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.
+Added: A 510(k) application must be supported by extensive data, including technical information, labeling, human factors data and potentially clinical data to meet any Special Controls.
+Added: 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.
+Added: 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).
+Added: There are three Class II categories classified by the FDA for the interoperability of devices as a complete AID system that are intended to help support continued rapid innovation by streamlining the regulatory pathway for integrated products approved by the FDA.
In June 2018, our t:slim X2 was the first insulin pump designated by the FDA as compatible with integrated continuous glucose monitoring (iCGM) devices.
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If we are not able to satisfy those special controls, we would be required to seek approval for those products under the traditional PMA submission process.
+Added: PMA Application:
For Class III devices a PMA application must be supported by valid scientific evidence that typically includes extensive technical, pre-clinical, clinical, manufacturing and labeling data to demonstrate to the FDA’s satisfaction the safety and efficacy of the device.
−Removed: A PMA application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.
−Removed: After a PMA application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information.
−Removed: During this review period, the FDA may request additional information or clarification of information already provided.
−Removed: Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA.
+Added: During the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA.
In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to evaluate compliance with QSR, which requires manufacturers to implement and follow design, testing, control, documentation and other quality assurance procedures.
FDA review of a PMA application generally takes approximately one year but may take significantly longer.
−Removed: The FDA can delay, limit or deny approval of a PMA application for many reasons, including:
−Removed: • systems may not be deemed safe or effective to the FDA’s satisfaction;
−Removed: • the data from pre-clinical studies and clinical trials may be deemed insufficient to support approval;
−Removed: • the manufacturing process or facilities may not meet applicable requirements;
−Removed: • changes in FDA approval policies or adoption of new regulations may require additional data.
If an FDA evaluation of a PMA application is favorable, the FDA will issue either an approval letter, or approvable letter, which usually contains a number of conditions that must be met in order to secure final approval of the PMA.
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The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.
−Removed: The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and eligible for abbreviated IDE requirements.
Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards at the clinical trial sites.
The FDA’s approval of an IDE allows clinical testing to go forward, but it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.
−Removed: All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
−Removed: Clinical trials must further comply with the FDA’s regulations for institutional review board approval and for informed consent and other human subject protections.
−Removed: Required records and reports are subject to inspection by the FDA.
−Removed: The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product.
−Removed: The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application or a 510(k) notification, for numerous reasons, including, but not limited to, the following:
−Removed: • the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;
−Removed: • patients do not enroll in clinical trials at the rate expected;
−Removed: • patients do not comply with trial protocols;
−Removed: • patient follow-up is not at the rate expected;
−Removed: • patients experience adverse side effects;
−Removed: • patients die during a clinical trial, even though their death may not be related to the products that are part of our trial;
−Removed: • institutional review boards and third-party clinical investigators may delay or reject the trial protocol;
−Removed: • third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, good clinical practices or other FDA requirements;
−Removed: • we or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or in a manner consistent with the clinical trial protocol or investigational or statistical plans;
−Removed: • third-party clinical investigators have significant financial interests related to us or our study that the FDA deems the study results unreliable, or the company or investigators fail to disclose such interests;
−Removed: • regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials;
−Removed: • changes in governmental regulations or administrative actions;
−Removed: • the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or efficacy;
−Removed: • the FDA concludes that our trial design is inadequate to demonstrate safety and efficacy.
We are currently sponsoring or supporting several clinical trials that are intended to support future enhancements to our AID products.
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Inspections may include the manufacturing facilities of our subcontractors.
−Removed: In general, failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies.
−Removed: These may include any of the following sanctions or consequences:
−Removed: • warning letters or untitled letters that require corrective action;
−Removed: • fines and civil penalties;
−Removed: • unanticipated expenditures;
−Removed: • delays in approving or refusal to approve future products;
−Removed: • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries;
−Removed: • suspension or withdrawal of FDA clearance or approval;
−Removed: • product recall or seizure;
−Removed: • interruption of production;
−Removed: • operating restrictions;
−Removed: • injunctions;
−Removed: • criminal prosecution.
−Removed: We and our contract manufacturers, specification developers and some suppliers of components or device accessories, are required to manufacture our products in compliance with current Good Manufacturing Practice, (GMP), requirements set forth in the QSR.
−Removed: The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.
−Removed: The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.
−Removed: If the FDA believes that we or any of our contract manufacturers, or regulated suppliers, are not in compliance with these requirements, it can shut down our manufacturing operations, require recall of our products, refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.
−Removed: In the United States, several states require that durable medical equipment (DME) providers be licensed in order to sell products to patients in that state.
+Added: In the United States, several states require that durable medical equipment (DME) providers be licensed to sell products to patients in that state.
Some of these states require that DME providers maintain an in-state location or retain a licensed pharmacist, and in those states, we sell our products through a third-party distributor.
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Foreign Corrupt Practices Act (FCPA), and similar laws in foreign jurisdictions generally prohibit U.S.
−Removed: corporations and their representatives from offering, promising, authorizing or making improper payments, gifts or transfers to any foreign government official in order to obtain or retain business.
+Added: corporations and their representatives from offering, promising, authorizing or making improper payments, gifts or transfers to any foreign government official to obtain or retain business.
The scope of the FCPA would include interactions with certain healthcare professionals and hospital administrators in many countries.
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Outside of the European Union, regulatory approval would need to be sought on a country-by-country basis in order for us to market our products.
−Removed: With the consummation of the United Kingdom’s (UK) exit from the European Economic Area, commonly referred to as Brexit, the UK is not scheduled to transition to the Medical Device Regulation but will continue to operate under existing directives.
−Removed: Although many classes of devices have grace periods, beginning on January 1, 2021, medical devices placed on the UK market are required to register with the Medicines and Healthcare Products Regulatory Agency.
−Removed: Registrations can only be submitted by UK manufacturers or by a UK Responsible Person who has a place of business in the UK.
−Removed: A UK Responsible Person is a person who acts on behalf of a manufacturer established outside the UK in relation to specified tasks with regard to the manufacturer’s obligations.
−Removed: Information Security
−Removed: We have implemented, and continually improved, an Information Security Program that was developed to secure our non-public information, systems, networks, databases, and workstations.
−Removed: This program is built on fundamental data security principles, which create the baseline suite of security controls that we have adopted to govern our current and future data security compliance mandates and practices.
−Removed: All of our employees are required to complete annual information security education training, which includes identifying suspicious emails, preventing virus and ransomware attacks, and avoiding other threats.
−Removed: We regularly review and modify our information security program to reflect changes in technology, laws, regulations, risks, industry practices, and other business needs.
−Removed: On an annual basis, we receive external audits of our information security posture, after which we remediate any findings.
−Removed: We hold cybersecurity insurance to mitigate against losses from a range of potential cyber incidents.
−Removed: Our management briefs our board of directors or a committee thereof on information security on a quarterly basis.
−Removed: Environmental Impact and Sustainability
+Added: We have obtained the right to affix the CE Mark to the t:slim X2 Insulin Delivery System, which allows us to distribute this product throughout the European Union and in other countries that recognize the CE Mark.
+Added: In addition, we have Health Canada approval to sell the t:slim X2 in Canada.
+Added: 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.
+Added: These laws include the U.K.
+Added: Bribery Act and similar antibribery laws in other jurisdictions in which we operate.
+Added: 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.
+Added: Bribery Act, to any person.
+Added: General Data Protection Regulation.
+Added: The General Data Protection Regulation (“GDPR”) is a comprehensive update to the data protection regime in the European Economic Area that imposes requirements relating to, among other things, consent to process personal data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches and use of third-party processors.
+Added: If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties for noncompliance.
+Added: Environment, Social and Governance
We have a focused effort on understanding the environmental impact of our business, both the direct impact as an employer and manufacturer, as well as the impact resulting from consumer use of the products we offer.
−Removed: We have metrics and initiatives across the business in support of these efforts, and our company goals for 2022 include driving economic efficiencies and process improvement, with environmental impact in mind.
−Removed: As an employer and manufacturer, we are mindful of the impact our facilities and employee transportation have on the environment.
−Removed: In September 2021, we signed a new lease agreement for approximately 180,000 square feet of additional general administrative, laboratory, and research and development office space.
−Removed: This building is certified under the
−Removed: Green Building Council's Leadership in Energy and Environmental Design (LEED), and energy use and environmental impact were key factors in the selection of our new facility.
−Removed: We intend to use this facility, which features a solar generating power system, for our operations that are currently located at four separate buildings, which is anticipated to result in more efficient energy use and reduced consumption of resources.
−Removed: In addition, we have reduced our general administrative space requirements, as in 2021 we adopted a remote-hybrid work policy for a majority of employees following the recent periods in which they worked remotely due to the COVID-19 pandemic.
−Removed: This helps to reduce carbon emissions associated with employees commuting to our facility on a daily basis.
−Removed: We have metrics in place to monitor our environmental impact on a monthly basis, including electricity consumption, electricity cost, and weight of waste (non-hazardous, hazardous, biohazard, universal and recycling).
−Removed: In addition, we have initiatives in place in support of monitoring and reducing our environmental impact.
−Removed: For example, our standby diesel generators are monitored and regulated by California’s Air Pollution Control District and their runtime is limited and closely monitored.
−Removed: In addition, we have dedicated efforts toward the reduction of energy use in our lighting.
−Removed: We have actively pursued rebates from San Diego Gas & Electric to fund energy improvement projects, and our facilities use LED lighting, motion sensors, or both, to reduce energy consumption.
−Removed: We are also working to reduce energy consumption for air conditioning and heating through occupancy scheduling.
−Removed: Our manufacturing processes are not water intensive, and we use hands-free automatic sink faucets and automatic toilet flush valves in all buildings.
−Removed: We are also working to reduce landfill waste by baling and recycling our cardboard, and we have a commingled recycling program in place.
−Removed: The environmental impact of consumer use of our product offerings is also a focus for our company.
−Removed: This starts with innovation in our product design.
−Removed: The t:slim X2 has two key environmental design features that are a competitive advantage:
−Removed: Our t:slim X2 insulin pump utilizes a rechargeable battery via its micro-USB port, eliminating the need to use alkaline batteries, which are commonly used in our competitors’ insulin pumps.
−Removed: We estimate that our customers have kept approximately 13 million disposable batteries out of landfills since our pumps became available in 2012, and that over the life of their pumps, together these users will save over 26.4 million batteries.
−Removed: Since August 2017, more than 130,000 of our pumps have been remotely updated through our Tandem Device Updater, which means that fewer screens, batteries, and circuit boards needed to be replaced.
−Removed: The t:slim X2 is unique in that it is the only pump on which remote software updates have been made commercially available in the United States.
−Removed: In addition, we utilize a refurbishment program that allows for the use of key components thereby reducing electronic waste.
−Removed: We are also mindful of the environmental impact of our supply chain efforts.
−Removed: For example, we utilize sea freight for a majority of our international shipments, which has lower emissions than road or air.
−Removed: We also use electronic forklifts and repeat pallet use in our warehouse operations.
−Removed: Our third party logistics provider, Omni, signed the Climate Pledge in Q3 2021 committing to net zero carbon by 2040.
−Removed: In addition, our supplier agreements warrant that all products sold to us are manufactured in full compliance with all applicable national, provincial, state and local environmental, health and safety statutes, acts, ordinances, rules, codes, standards, laws and regulations and elimination of human trafficking, child labor, or modern slavery.
−Removed: We also receive annual conflict mineral disclosure from our suppliers.
−Removed: We continue to use innovative techniques to reduce environmental impact and deliver products that can change people’s lives.
−Removed: For example, our product pipeline includes Mobi Tubeless, which is being developed to provide a tubeless infusion site option for our Mobi pump that allows the pump portion to be reused rather than disposed of every three days.
−Removed: Our research and development efforts also include infusion set innovations that focus on extending the length of infusion set wear, thereby reducing the number of sets used per customer, and reducing waste.
−Removed: Community Outreach and Impact
−Removed: We strive to be a good corporate citizen in the communities in which our employees live and work.
−Removed: For many people with diabetes, peer support plays a key role in successful diabetes management.
−Removed: To help fulfill this need, we provide support to a broad spectrum of people and organizations providing peer support and education through diabetes programs such as JDRF, Beyond type 1, Connected in Motion, Riding on Insulin, College Diabetes Network, Diabetes Exercise and Camping Association, and Touched by Type 1, among others, as well as regional diabetes events such as Children with Diabetes, Taking Control of Your Diabetes, American Diabetes Association, and camps where our employees participate and volunteer.
−Removed: Our employee community outreach efforts include donations and volunteer work, serving on boards and advisory committees and other corporate and individual actions.
−Removed: Examples of our corporate giving efforts include:
−Removed: • Bright Funds Employee Giving & Volunteering platform launch, which provides employees choice to where they direct giving and volunteering time for causes of significance to them.
−Removed: • JDRF annual employee fundraising campaign in support of diabetes research.
−Removed: • Athena sponsorships in support of women in STEM leadership in San Diego, including the Lifting While Climbing Summit and “Clinical Trial Diversity:
−Removed: Closing the Gap to Achieve Health Equity” event.
−Removed: • Virtual Spanish Summit hosted by our community partners, JDRF and Beyond Type One designed to reach the Spanish-speaking type 1 diabetes population in the United States.
−Removed: • Diabetes Camp Partnerships with Camp Conrad Chinnock and Camp Kudzu that specifically support underserved communities.
−Removed: • Spare a Rose campaign in support of Life For a Child which provides under-resourced countries with insulin, supplies and diabetes education.
+Added: We have metrics and initiatives across the business in support of these efforts, and our company goals include driving economic efficiencies and process improvement, with environmental impact in mind.
+Added: Additional information about our Environmental, Social and Governance practices can be found on our website within the “Investor Center” section.
+Added: The information contained on or accessed through our website does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references only.
Human Capital
We are committed to creating and maintaining a safe, diverse, and inclusive community for all employees while we serve our customers and fulfill our mission to improve the lives of people with diabetes.
−Removed: As of December 31, 2021, we had approximately 2,000 regular full-time employees, all of whom work in the United States or Canada.
+Added: As of December 31, 2022, we had approximately 2,600 regular full-time employees, who primarily work in the United States, Canada, or Europe.
The term “employees” in this Annual Report means our regular full-time employees.
Our headquarters are in San Diego, CA, where our primary research and development and administrative headquarters are located, and where we also operate a manufacturing facility and a warehousing facility.
−Removed: In addition, we maintain an office in Boise, Idaho, where employees focus primarily on customer care and training and quality related activities, and an office in Markham, Ontario, Canada.
None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
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Our Words We Live By describe our core values and reflect who we are and the way our employees interact with one another, our customers, partners and stockholders.
−Removed: Innovate Every Day is our commitment to run our business with the future in mind to deliver products that improve people’s lives, ensure continuous product improvements and exemplary customer support.
−Removed: No Shortcuts is holding ourselves to the highest ethical standards and delivering exceptional quality.
−Removed: Team Up highlights the importance of successful collaboration that is inclusive of diverse perspectives, both inside and outside of the Company.
−Removed: Stay Awesome reflects a universal respect among employees which allows us the freedom to be ourselves and to be effective at our jobs, knowing at the end of the day that we can trust everyone to do the right thing, for our customers, our investors and each other.
−Removed: People First emphasizes the deep care we have for the people who use our products, their loved ones and health care providers.
−Removed: We are committed to involving end users in the research and development of our products and customer support efforts, to develop products and services that truly bring convenience, innovation, and usability to diabetes management.
−Removed: In 2021, we conducted our first employee engagement survey through Gallup, a leading global consulting firm on employee engagement.
−Removed: More than 90% of our employees participated, and the results demonstrated that our overall engagement levels exceed Gallup’s averages worldwide, in the United States, and in life sciences.
+Added: In both 2021 and 2022, we conducted employee engagement surveys through Gallup, a leading global consulting firm on employee engagement.
+Added: More than 90% of our employees participated in both years, and the results demonstrated that our overall engagement levels exceed Gallup’s averages worldwide, in the United States, and in life sciences.
The results also reflected that we are a mission-driven company with employees’ response on our strength of purpose far exceeding Gallup’s measurement for world class.
−Removed: We have detailed ethics and compliance policies that instill a commitment to ethical behavior and legal compliance across our company.
−Removed: Employees are encouraged to approach their managers if they believe violations of standards or policies have occurred.
−Removed: Employees are also able to make confidential and anonymous reports using an online or telephone hotline hosted by a third party provider.
+Added: In 2022, we earned the Great Place to Work Certification, a prestigious award based entirely on results from in-depth employee surveys around their experience working at the Company.
+Added: This certification is the most definitive “employer-of-choice” recognition that companies aspire to achieve and is recognized worldwide by employees and employers alike and is the global benchmark for identifying and recognizing outstanding employee experience.
Diversity, Equity and Inclusion
Our diversity, equity and inclusion (DE&I) goals focus on cultivating and encouraging an inclusive and equitable culture where diversity of thought is represented and can thrive throughout our organization.
−Removed: We believe that a culture of inclusion and diversity enables us to create, develop and fully leverage the strengths of our workforce to exceed customer expectations and meet our growth objectives.
−Removed: More than half of our employees are female, includin g one-third of o ur employees at the Vice President level or higher, and approximately half of our employees are from an underrepresented ethnic community.
+Added: More than half of our employees are female, includin g 40% of o ur employees at the Vice President level or higher, and approximately half of our employees are from an underrepresented ethnic community.
We believe that bringing together different perspectives and experiences is fundamental to innovation and continuing to raise the bar in the field of diabetes technology.
−Removed: 2021 was our first full year of having a DE&I Council.
+Added: 2021 was our first full year of having a DE&I Council, which we continued and expanded during 2022.
This Council is sponsored by executive management and we provide regular updates to our Board of Directors on its initiatives and progress.
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In addition, we are focused on cultivating and supporting our internal culture through diversity of thought, support and advocacy within the diabetes community and continuing to build and maintain a diverse and inclusive workforce.
−Removed: Many of our community outreach and impact efforts are focused on support for diversity-related causes.
−Removed: We have also been expanding our support for diabetes-related clinical investigators, camps, and other organizations that are actively focusing their research on underserved groups.
−Removed: We embrace the importance of diverse cultural perspectives in the customer stories we promote, which is reflected in our website articles, social media posts, and roster of compensated ambassadors, and influences our sponsorship and grant commitments.
Organizational Development
Attracting, developing and retaining employees is critical to our longer-term success.
−Removed: In mid-2021, we began evolving our organizational structure by creating new senior leadership positions to strengthen our management team as we prepare for continued growth, near-term product expansions and the execution of our longer-term product pipeline strategy.
−Removed: In addition, to support the advancement of our employees, we offer training and development programs encouraging advancement from within and continue to fill our team with strong and experienced management talent.
−Removed: We leverage both formal and informal programs to identify, foster, and retain top talent at both the corporate and operating level.
We have established a comprehensive training program to develop employees throughout the organization.
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In 2022, more than 450 employees participated in our leadership development programs.
−Removed: In addition, more than 800 employees participated in our first virtual Peak Performance Summit in 2021, with both internal and external experts as part of Employee Development Week.
−Removed: Our leadership team also mentors rising talent on a more informal basis.
−Removed: This informal mentorship achieves a number of goals, including accelerating the development of top performers, increasing organizational learning, and improving employee performance and retention.
−Removed: The executive team also commits substantial time to evaluating the bench strength of our leadership and working with our leadership to improve their performance.
−Removed: Total Rewards
−Removed: We have demonstrated a history of investing in our workforce by offering competitive salaries and wages.
−Removed: Annual increases and incentive compensation are based on merit, which is communicated to employees at the time of hiring and documented through our talent management process as part of our annual review procedures and upon internal transfer and/or promotion.
+Added: Competitive Total Rewards
+Added: Our compensation program is designed to align employee compensation with our performance and to provide the proper incentives to attract, retain, and motivate employees to achieve superior results.
+Added: The structure of our compensation program balances incentive earnings for both short-term and long-term performance.
+Added: • We provide employee wages that are competitive and consistent with employee positions, skill levels, experience, knowledge, and geographic location.
+Added: • We engage internationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness of our executive compensation and benefit programs and to provide benchmarking.
+Added: • We align our executives’ long-term equity compensation with our stockholders’ interests.
+Added: • Annual increases and incentive compensation are based on our performance as well as each individual’s contribution to the results achieved and are documented through our talent management process as part of our annual review process.
To foster a stronger sense of ownership and align the interests of partners with stockholders, stock options and/or restricted stock units are provided to a substantial proportion of our employees under our broad-based stock incentive programs.
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Furthermore, we offer comprehensive, locally relevant and innovative benefits to all eligible employees, including health insurance, paid time off, paid and unpaid leaves, a retirement plan, health savings accounts, flexible spending accounts, life and disability coverage, voluntary accident, critical illness, legal and identity theft coverage, employee discount program, and an employee loaner pump program.
−Removed: In addition, we engage nationally recognized outside compensation and benefits consulting firms to independently evaluate the effectiveness of our executive compensation and total rewards programs and to provide benchmarking against our peers within the industry.
Employee Health and Safety
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For example, as a benefit to our employees and their eligible dependents, we provide access to personal and job-related counseling and assistance resources for addressing concerns such as emotional well-being, family and relationships, legal and financial matters, healthy lifestyles, mental health, substance abuse, and work and life transitions.
−Removed: Every work day we provide a virtual wellness session featuring guided meditation, stretching, yoga, or exercise.
−Removed: Our focused wellness education sessions, generally offered several times per month, cover topics such as parenting, mental health, nutrition, stress management, sleep habits, resilience, and working in a remote environment.
−Removed: We host an online wellness lounge and mental health toolkit with a range of recorded learning sessions and articles, and our monthly benefits newsletter updates employees on our various health and wellness benefits programs.
−Removed: In 2021, we implemented safety management software to better manage safety inspections, assessments, and safety data sheets.
We have comprehensive safety training programs that ensure our employees know how to do their jobs safely and in compliance with laws and regulations.
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zero accidents.
−Removed: In the COVID-19 global pandemic, we have been deemed an essential healthcare business under applicable governmental orders based on the critical nature of the products we offer and the communities we serve.
−Removed: As a result, our manufacturing and warehousing sites continued operating during the COVID-19 pandemic.
−Removed: As such, we have invested in creating physically safe work environments for our employees through the implementation of new protocols, trainings and communications.
−Removed: COVID-19 Global Pandemic Impact and Considerations
−Removed: Our business has been impacted in a variety of ways since the onset of the COVID-19 global pandemic in early 2020, and will likely continue to be impacted for the remainder of 2022.
−Removed: Specific factors that have influenced our financial results and the way in which we operate include fluctuations in shelter-in-place restrictions, supply chain constraints, labor shortages, the timing and extent of vaccine availability and surges in infection and hospitalization rates as new COVID variants have emerged.
−Removed: Throughout this time, we have responded to each of these unique challenges, while prioritizing the health and safety of our employees and customers and working diligently to maintain a continuous supply of products, training and customer support.
−Removed: Most notably, our sales results reflected a high degree of variability across the quarters during this time, unlike historical seasonal trends.
−Removed: We experienced a modest impact early in 2020, which became more pronounced and continued in varying degrees as the pandemic progressed.
−Removed: Initially, the impact on our business was relatively consistent worldwide but we have since seen variations in individual markets based on local conditions and anticipate ongoing fluctuations may continue.
−Removed: Our inventory levels have also fluctuated as we respond to supply chain constraints, due to availability of components from the various suppliers we use to build our products.
−Removed: While we have adequate raw material inventory for a substantial portion of our pump and cartridge components, we are below our targeted stocking levels for others.
−Removed: In early 2020, we initiated regular discussions with our key suppliers regarding their abilities to fulfill existing orders and assess their ongoing capacity.
−Removed: Over the course of the pandemic, we have increased the frequency of those communications.
−Removed: We continue to monitor factors that could negatively impact our supply chain, such as global shortages of semiconductors, copper and paper, as well as custom components for our insulin pumps and cartridges where we rely on a limited number of qualified suppliers.
−Removed: We anticipate experiencing continued challenges managing supply chain constraints, including the potential for limitations on availability of components as well as increased purchase costs.
−Removed: Generally, our entire operation has been impacted as we navigate the generalized labor shortages impacting global markets.
−Removed: The labor challenges affect our ability to recruit and hire key talent at the same pace as in years past, but we remain active in our recruiting efforts and competitive in our offerings.
−Removed: In particular, these labor challenges combined with regulatory delays have impacted our product development and launch timelines.
−Removed: The FDA has generally stated that its review process may take longer than normal due to prioritization of COVID-related products and services.
−Removed: We have experienced lengthy delays in the review of pending submissions with the FDA, making regulatory timelines increasingly difficult to predict.
−Removed: We have adapted well in our commercial operations and customer-facing functions.
−Removed: Our sales organization balances remote and in-person interactions based on the needs and requirements of the customers with whom they interact.
−Removed: For example, prior to the onset of the pandemic, nearly all trainings for customers purchasing our pump platform were in-person.
−Removed: We quickly pivoted to nearly all trainings being provided on remote platforms.
−Removed: Since that time, we have achieved a balance that includes options for the individual based on their unique needs.
−Removed: We continue to see variability across the markets in which we operate and anticipate these fluctuations between in-person and remote interactions will continue.
−Removed: Our facilities have been closed for non-essential purposes throughout most of the pandemic, while our manufacturing operations were deemed essential due to the critical nature of our product and the communities that we serve.
−Removed: To help ensure the safety and health of those employees working in our facilities, we have implemented preventative measures by requiring employees to wear masks and perform temperature checks before each shift.
−Removed: We are currently developing a return-to-work strategy for the rest of the organization that will incorporate a hybrid approach to meet the needs of our employees, as well as optimize usage of our facilities.
−Removed: Overall, we anticipate that our sales and operating results will continue to be impacted and subject to unpredictable variability.
−Removed: The full extent of the impact of the pandemic on our future business and operations is difficult to estimate and will depend on a number of factors including the scope and duration of the COVID-19 global pandemic, and the relative impact of COVID-19 on the business operations of our contract manufacturers, suppliers and competitors.
−Removed: Sheridan (age 66) has served as our President and Chief Executive Officer since March 2019 and as a member of our board of directors since June 2019.
−Removed: Sheridan previously served as Executive Vice President and Chief Operating Officer since April 2013.
−Removed: Prior to joining our company, Mr.
−Removed: Sheridan served as Chief Operating Officer of Rapiscan Systems, Inc., a provider of security equipment and systems, from March 2012 to February 2013.
−Removed: Sheridan served as Executive Vice President of Research and Development and Operations for Volcano Corporation, a medical technology company, from November 2004 to March 2010.
−Removed: From May 2002 to May 2004, Mr.
−Removed: Sheridan served as Executive Vice President of Operations at CardioNet, Inc., a medical technology company, now operating as BioTelemetry, Inc.
−Removed: From March 1998 to May 2002, he served as Vice President of Operations at Digirad Corporation, a medical imaging company.
−Removed: Sheridan holds a B.S.
−Removed: in Chemistry from the University of West Florida and an M.B.A.
−Removed: from Boston University.
−Removed: Berger (age 52) has served as our Executive Vice President and Chief Operating Officer since February 2022 and is responsible for the Company’s manufacturing, supply chain, quality, regulatory and clinical functions.
−Removed: He previously served as our Chief Business Operations and Compliance Officer si nce November 2020, as our Executive Vice President, Chief Legal and Compliance Officer since April 2019, and as General Counsel since August 2013.
−Removed: From January 2008 until August 2013, Mr.
−Removed: Berger was employed at Senomyx, Inc., a taste science company, where he most recently served as Senior Vice President and General Counsel.
−Removed: From April 2003 until October 2007, Mr.
−Removed: Berger was responsible for all commercial aspects of legal affairs at Biosite Incorporated, Biosite, a provider of medical diagnostic products, most recently serving as Vice President, Legal Affairs.
−Removed: Previously, Mr.
−Removed: Berger was an attorney at Cooley Godward LLP and Amylin Pharmaceuticals, Inc.
−Removed: Berger holds a B.A.
−Removed: in Economics from the University of California, Berkeley and a J.D.
−Removed: from Stanford Law School.
−Removed: Carpenter (age 58) has served as our Chief Technical Officer since November 2021.
−Removed: Prior to joining our company, Mr.
−Removed: Carpenter served from February 2020 as the Senior Vice President of Engineering at Inseego Corporation, where he led the worldwide engineering team and was responsible for device hardware and software, cloud software, quality assurance, regulatory and product certification and technical account management.
−Removed: From April 2017 to January 2020, he was the General Manager of the IoMT Business and the Senior Director of Engineering at Capsule Technologies, a company that integrates medical devices and wearables into a secure medical grade system that collects data and provides it to healthcare professionals for patient monitoring.
−Removed: Prior to that, from May 2009 until March 2017, Mr.
−Removed: Carpenter served as the Senior Vice President of Engineering at Smith Micro Software.
−Removed: Earlier in his career, he held various engineering development and leadership roles at Nextwave Wireless, Sierra Wireless, General Dynamics, Motorola and Denso.
−Removed: Carpenter received a BS in Computer Science from The University of Texas Permian Basin, and completed coursework for a MS in Computer Science from The University of Texas at Arlington.
−Removed: Gasser (age 46) has served as our Executive Vice President, Strategy and Corporate Development since January 2020.
−Removed: Prior to joining our company, Ms.
−Removed: Gasser served from June 2017 as an independent adviser providing strategic and corporate development solutions to boards and executive teams.
−Removed: From January 2016 to June 2017 she was Vice President of Corporate Strategy at QUALCOMM Technologies, Inc.
−Removed: (QTI), a subsidiary of QUALCOMM Incorporated (Nasdaq:
−Removed: QCOM), a global leader in the development and commercialization of technologies and products used in mobile devices and other wireless products.
−Removed: Prior to that, from November 2012 to January 2016 she was Vice President of Strategic Development at QTI, after serving in other strategic related roles of increasing responsibility beginning in 2006.
−Removed: Gasser holds a B.A.
−Removed: in Economics from the University of Cambridge.
−Removed: Hansen (age 54) has served as our Executive Vice President and Chief Commercial Officer since February 2016.
−Removed: Prior to joining our company, Mr.
−Removed: Hansen served from September 2014 as Chief Commercial Officer of Adaptive Biotechnologies Corp.
−Removed: From May 2013 to September 2014, Mr.
−Removed: Hansen served as Head of Commercial, Sales and Marketing, of Genoptix, a Novartis Company.
−Removed: From December 2005 to February 2013, he served in various roles of increasing responsibility at Gen-Probe, Inc., a medical diagnostics company, most recently serving as Senior Vice President, Global Sales and Services from January 2012 to February 2013.
−Removed: Hansen received a B.S.
−Removed: in Business Administration from the University of Missouri-Columbia, and an M.B.A.
−Removed: from the School of Business at San Diego State University.
−Removed: Hansen (age 56) has served as Senior Vice President, General Counsel, Chief Compliance Officer and Secretary since January 2022 and is responsible for the Company's legal, compliance and privacy functions.
−Removed: Before joining our Company, Ms.
−Removed: Hansen served as General Counsel, Corporate Secretary and Chief Privacy Officer at Alto Pharmacy from April 2020 to September 2021, where she oversaw the development of the legal, privacy and compliance functions.
−Removed: Before her role at Alto Pharmacy, she held various leadership roles at Abbott, including Division Vice President & Associate General Counsel, Patents from June 2017 to February 2020, Division Vice President and Associate General Counsel for the Diabetes, Vascular and Structural Heart divisions from June 2015 to June 2017, Head of Legal for the Diabetes Division from January 2013 to June 2015, and Division Counsel, Patents from May 2009 to December 2012.
−Removed: Earlier in her career, she served as a partner at Kirkland & Ellis LLP, a global law firm, and worked in the Solicitor’s Office at the United States Patent and Trademark Office.
−Removed: Hansen holds a BS in Chemical Engineering from Carnegie Mellon University, and a JD from Stanford Law School.
−Removed: James Leal (age 58) has served as our Senior Vice President, Operations since August, 2017.
−Removed: Leal joined Tandem in October 2010 as Vice President, Operations.
−Removed: Previously, Dr.
−Removed: Leal was the Vice President of Manufacturing and Field Support for Volcano Corporation and held Director Roles with CardioNet, Inc.
−Removed: and Digirad Corporation.
−Removed: He held Senior Engineering roles with FlipChip Technologies and Hughes Aircraft Company.
−Removed: He has won several awards including a Hughes Aircraft Doctoral and Masters Fellowship and was a recognized nominee for Most Promising Hispanic Engineer of the Year Award.
−Removed: Leal is a University of Arizona graduate with a B.S.
−Removed: in Metallurgical Engineering, and both a M.S.
−Removed: and a PhD in Materials Science and Engineering.
−Removed: Morrison (age 42) has served as our Chief Administrative Officer since September 2013 and as an Executive Vice President since December 2017, and is responsible for the Company’s investor relations, corporate communications, program management, human resources and facilities functions.
−Removed: From April 2013 until September 2013, she served as our Vice President, Human Resources, Corporate and Investor Relations.
−Removed: Morrison served as our Director, Corporate and Investor Relations, from January 2009 to March 2013, and was our Director, Corporate Services from November 2007 to December 2008.
−Removed: Prior to joining our company, Ms.
−Removed: Morrison held various positions in Corporate and Investor Relations at Biosite from August 2003 through November 2007.
−Removed: Morrison holds a B.A.
−Removed: in Public Relations from Western Michigan University.
−Removed: Vosseller (age 49) has served as our Executive Vice President, Chief Financial Officer, and Treasurer since June 2018, and served as Senior Vice President, Chief Financial Officer and Treasurer from January 2018 to May 2018.
−Removed: Vosseller is our principal financial and accounting officer.
−Removed: She joined us as Vice President of Finance in 2013 and was promoted to Senior Vice President of Finance in August 2017.
−Removed: Prior to that time, she served as Vice President and Chief Financial Officer at Genoptix, beginning in 2011, after initially joining Genoptix in 2008.
−Removed: Prior to that she held a senior finance position at Biosite where she played a key role in developing the financial and administrative infrastructure for international expansion.
−Removed: Vosseller is a certified public accountant (inactive) and holds a B.S.
−Removed: in Accounting from Missouri State University.
+Added: Throughout the COVID-19 global pandemic, we were deemed an essential healthcare business under applicable governmental orders, and our manufacturing and warehousing sites continued operating during the COVID-19 pandemic.
+Added: As such, we invested in creating physically safe work environments for our employees through the implementation of new protocols, trainings and communications.
+Added: Information about our Executive Officers
+Added: Name Age Title
+Added: Sheridan 67 President and Chief Executive Officer
+Added: Berger 53 EVP and Chief Operating Officer
+Added: Carpenter 59 Chief Technical Officer
+Added: Gasser 47 EVP and Chief Strategy Officer
+Added: Hansen 55 EVP and Chief Commercial Officer
+Added: Hansen 57 SVP, General Counsel, Chief Compliance Officer and Secretary
+Added: James Leal 59 SVP, Operations
+Added: Morrison 43 EVP and Chief Administrative Officer
+Added: Vosseller 50 EVP, Chief Financial Officer, and Treasurer
+Added: Further detailed information about our executive officers not referenced or set forth above, is provided in our definitive Proxy Statement for our 2022 Annual Meeting of Stockholders and will be included in our definitive Proxy Statement for our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
Family Relationships
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Our website address is www.tandemdiabetes.com .
−Removed: We post links to our website to the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the SEC:
−Removed: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act).
−Removed: All such filings are available through our website free of charge.
−Removed: However, the information contained on or accessed through our website does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references only.
+Added: Copies of our filings with the SEC are available free of charge on our website within the “Investor Center” section as soon as reasonably practicable after having been electronically filed with or furnished to the SEC.
+Added: The information contained on or accessed through our website does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references only.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.