−Removed: We are a medical device company with a positively different approach to the design, development and commercialization of products for people with insulin-dependent diabetes.
−Removed: Diabetes management can vary greatly person-to-person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: We aim to improve and simplify the lives of all people living with insulin-dependent diabetes and those of their healthcare providers, by delivering innovative hardware and software solutions, as well as best-in-class customer support.
−Removed: Our goal is to lead in insulin therapy management by building a robust ecosystem and portfolio of data-driven products and services around our flagship insulin pumps.
−Removed: We believe our competitive advantage is rooted in our consumer-focused approach, and the incorporation of modern and innovative technology into our product offerings.
−Removed: Our manufacturing, sales and support activities principally focus on our flagship pump platform, the t:slim X2 Insulin Delivery System (t:slim X2), and our complementary product offerings.
−Removed: Since our initial commercial launch, we have been able to rapidly innovate and bring more products to market than our competitors.
+Added: We are a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes.
+Added: Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
+Added: 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: Since our initial commercial launch, we have rapidly innovated and brought more products to market than our competitors.
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 hardware platform represents 100% of our new pump shipments.
−Removed: Our simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available.
−Removed: We have commercially offered our pump technology integrated with three generations of Dexcom’s continuous glucose monitoring (CGM) sensors.
−Removed: The t:slim X2 is the only pump on which remote software updates have been commercially available in the United States.
−Removed: This experience, which offers and supports different software updates, provides us with a unique competitive advantage.
−Removed: Two of our updates provided our users access to our automated insulin delivery (AID) algorithms, Basal-IQ technology and Control-IQ technology.
−Removed: Basal-IQ technology launched in August 2018 and is a predictive low glucose suspend feature that is designed to temporarily suspend insulin delivery to help reduce the frequency and duration of hypoglycemic events.
−Removed: Control-IQ technology launched in January 2020 and is an advanced hybrid-closed loop feature, designed to help increase a user's time in targeted glycemic range.
−Removed: It is the first and only system cleared by the United States Food and Drug Administration (FDA) to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.
−Removed: Outside the United States we began selling efforts with t:slim X2 with Dexcom G5 integration in the third quarter of 2018, offering no-cost software updates for Basal-IQ technology in the third quarter of 2019 and for Control-IQ technology beginning in the third quarter of 2020.
−Removed: We intend to complete our scaled launch of Control-IQ technology outside the United States in the first half of 2021, subject to securing necessary regulatory clearances or approvals.
−Removed: We continue to offer both AID algorithms on the market to support the varying needs of people living with diabetes.
−Removed: In support of our digital health strategy, we also offer t:connect, a web based data management 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: In the first quarter of 2020, we began a limited launch in the United States of our first-generation t:connect mobile application, followed by general availability in July 2020.
−Removed: The t:connect mobile application features wireless upload of pump data to t:connect, allows the user to receive notification of pump alerts and alarms, and provides a discrete, secondary display of glucose and insulin data.
−Removed: In addition, in the second quarter of 2020, we acquired Sugarmate, a popular app designed to help people visualize diabetes therapy data in innovative ways that also connects with many other popular, consumer-friendly devices.
+Added: Today, our software-updatable t:slim X2 Insulin Delivery System (t:slim X2) hardware platform represents 100% of our new pump shipments.
+Added: 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.
+Added: Nearly 240,000 of these pumps were shipped to customers in the United States and nearly 90,000 were shipped to international markets.
+Added: Our manufacturing, sales and support activities principally focus on our flagship pump platform, the t:slim X2 and our complementary product offerings.
+Added: 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.
+Added: 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: It was the first system cleared by the U.S.
+Added: 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.
+Added: 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.
+Added: 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: 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.
+Added: 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.
+Added: 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.
Our insulin pump products are generally considered durable medical equipment and have an expected lifespan of at least four years.
−Removed: 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, as well as a variety of accessories designed for enhanced usability.
−Removed: In the four-year period ended December 31, 2020, we shipped more than 215,000 insulin pumps, which is representative of our estimated global installed customer base, assuming the typical four-year reimbursement cycle.
−Removed: More than 170,000 of these pumps were shipped to customers in the United States and nearly 45,000 were shipped to international markets.
+Added: 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.
+Added: Additionally, we sell accessories such as belt clips and cases for use with pumps which are designed to enhance usability.
+Added: 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.
Our primary research and development and administrative headquarters are located in San Diego, California.
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• Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin.
−Removed: It is frequently diagnosed during childhood or adolescence.
−Removed: Individuals with type 1 diabetes require daily insulin therapy to survive.
+Added: It is frequently diagnosed as an acute event during childhood or adolescence.
+Added: Individuals with type 1 diabetes require intensive insulin therapy to survive.
• 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.
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 daily rapid-acting insulin therapy.
−Removed: The International Diabetes Federation estimates that, in 2019, approximately 231 million adults age 20-79 years worldwide had diagnosed type 1 or 2 diabetes worldwide.
+Added: 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.
+Added: The International Diabetes Federation estimates that, in 2021, approximately 297 million adults age 20-79 years worldwide had diagnosed type 1 or 2 diabetes.
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.
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.
−Removed: 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 daily rapid acting insulin.
+Added: 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.
Throughout this Annual Report, we refer to these individuals as people with insulin-dependent diabetes.
Estimated Diagnosed Diabetes Prevalence (1)
−Removed: Worldwide Domestic
+Added: Worldwide United States
Type 1 30.9 million 1.8 million
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Diabetes can be difficult for patients to manage.
−Removed: Unlike most therapies, daily insulin requirements can vary greatly and can be affected by many factors, such as type or quantity of food eaten, illness, stress and exercise.
+Added: 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.
People with diabetes have to be diligent in working to prevent their blood glucose from fluctuating outside of a targeted range.
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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.
−Removed: In addition, insulin pumps may feature an AID algorithm that is designed to automatically adjust a person’s insulin delivery based on their CGM trends and other factors to help minimize the frequency and/or duration of hypoglycemia and/or hyperglycemic events.
+Added: In addition, insulin pumps may feature an AID algorithm that is designed to automatically adjust a person’s insulin delivery based on their CGM trends and other factors to help minimize the frequency and/or duration of hyperglycemic and/or hypoglycemic events.
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: The American Diabetes Association estimated that in 2015, between 750,000 and 1 million people worldwide used an insulin pump.
−Removed: Domestically, we estimate that 600,000 people in the United States use an insulin pump.
−Removed: There are a variety of insulin pump manufacturers worldwide, while domestically, we are currently one of only two commercial durable insulin pump manufacturers and there is one programmable commercial patch insulin pump manufacturer.
+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 the more than 20 countries outside the United States in which our insulin pump is available.
+Added: 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.
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.
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t:slim X2 October 2016 - September 2017 N/A
−Removed: t:slim X2 with G5 September 2017 - August 2018 September 2018 - present
−Removed: (varies by geography)
+Added: t:slim X2 with G5 September 2017 - August 2018 September 2018 - May 2021
t:slim X2 with Basal-IQ technology August 2018 - present September 2019* - present
−Removed: (varies by geography)
−Removed: t:slim X2 with Control-IQ technology January 2020 - present Scaling launch began July 2020
−Removed: (to vary by geography)*
−Removed: *Subject to regulatory approvals and other factors
+Added: t:slim X2 with Control-IQ technology January 2020 - present July 2020* - present
+Added: *Scaled launch based on the timing of regulatory approvals and other factors.
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.
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.
−Removed: It is also the only commercially available insulin pump featuring optional integration with Dexcom’s CGM.
−Removed: Our t:slim X2 Insulin Pump Form Factor (Actual Size)
+Added: Our t:slim X2 Insulin Pump Form Factor
t:slim X2 Insulin Pump
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• Color touchscreen - The large color touchscreen is easy to read, simple to learn, and intuitive to use for anyone familiar with a smartphone or tablet.
−Removed: • Small and discreet - The t:slim X2 pump is up to 38% smaller than other pumps, yet the device can hold up to 300-units of insulin.
+Added: • Small and discreet - The t:slim X2 pump is up to 38% smaller than other durable pumps, yet the device can hold up to 300-units of insulin.
t:slim X2 Profile (Actual Size)
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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 (availability varies by geography) - We have commercially launched two AID algorithms on our t:slim X2 platform:
+Added: • AID features - We have commercially launched two AID algorithms on our t:slim X2 platform:
Basal-IQ technology and Control-IQ technology.
4 unchanged sentences
This advanced hybrid-closed loop feature is designed to help increase a user's time in targeted glycemic range (70-180 mg/dL).
−Removed: It is the first and only system cleared to deliver automatic correction boluses in addition to adjusting 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 that change the treatment values to better match the different physiological needs during these activities.
+Added: Approximately 200,000 t:slim X2 users worldwide have our Control-IQ technology.
+Added: 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.
+Added: 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.
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.
−Removed: • Connectivity - The t:slim X2 features a two-way Bluetooth wireless technology radio for communicating with more than one external device at a time.
−Removed: It also features a micro-USB connection that supports charging the lithium-polymer battery, software updates and optional rapid data uploads.
+Added: • Connectivity - The t:slim X2 includes a Bluetooth radio for communicating with multiple external devices simultaneously and allows for uploading pump and CGM therapy data to the Tandem cloud via the t:connect mobile app.
+Added: The t:slim X2 also includes a micro-USB port that supports charging the lithium-polymer battery, software updates and therapy data uploads.
+Added: • Mobile Control - In the first quarter of 2022, we received FDA clearance for our mobile bolus feature that allows t:slim X2 users to control a bolus of insulin through our t:connect mobile app using their personal smartphone.
+Added: It is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems.
+Added: Our mobile app provides users with convenient and discreet data display and alerts, and functions as a pipeline for getting pump data to the cloud.
Tandem Device Updater
−Removed: A revolutionary tool that allows pump users to update their pumps’ software quickly and easily from a personal computer.
+Added: A tool that allows pump users to update their pumps’ 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: It was cleared by the FDA in the third quarter of 2016 and launched outside the United States in the third quarter of 2019.
−Removed: We have used this technology to offer in-warranty t:slim customers in the United States four different software updates for no-cost, including Basal-IQ technology, and most recently Control-IQ technology.
+Added: 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.
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.
−Removed: Subject to regulatory approvals and other factors, we intend to complete our scaled launch of Control-IQ technology outside the United States in the first half of 2021.
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.
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 identification of clinical outcomes data.
+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 identification of clinical outcomes data.
t:connect launched in the United States in the third quarter of 2013.
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.
−Removed: In the third quarter of 2020, we launched a new 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 2020, more than 80,000 customers had downloaded our mobile app.
−Removed: We believe t:connect can serve as a key component of additional mobile health applications that are currently under development.
+Added: 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.
+Added: 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: 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.
During the second quarter of 2020, we acquired Sugarmate, Inc.
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Sugarmate became a wholly owned subsidiary of Tandem, and is continuing to be led by its founder, who joined our Company.
−Removed: Enabled by our singular focus on diabetes management, our goal is to lead in insulin therapy management by building a robust ecosystem and portfolio of data-driven products and services around our flagship insulin pumps.
−Removed: We believe that our positively different approach uniquely positions us to significantly expand and further penetrate the varying segments of the insulin-dependent 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: Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
+Added: 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.
+Added: 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.
To achieve our goal, we intend to pursue the following business strategies:
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Products Under Development
−Removed: Our products under development support our strategy of focusing on both consumer and clinical needs, which can vary greatly person-to-person.
−Removed: We will be furthering our efforts to improve and simplify the lives of people living with type 1 diabetes, in addition to expanding our longer-term initiatives in support of people living with type 2 diabetes.
−Removed: Our product development efforts are designed to support different segments of the diabetes market by offering options that can be flexible, personalized, and used by themselves or in combination with other devices, and include:
−Removed: • creating new hardware platform options;
−Removed: • continuing AID system evolution;
−Removed: • expanding connected (mobile) health offerings;
−Removed: • adding and enhancing system components.
−Removed: New Hardware Platform Options
−Removed: Preference 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: We are expanding our development efforts to offer a family of pump hardware options to provide people with greater choice in the form factor that best fits their personal needs.
−Removed: Our new hardware platforms are being designed to be CGM integrated and compatible with our AID algorithms.
−Removed: The next new hardware platform that we expect to offer in addition to the t:slim X2 is referred to under its development name, the t:sport Insulin Delivery System, (t:sport).
−Removed: The t:sport pump is half the size of t:slim X2 and is expected to be controlled using our mobile device application.
−Removed: It is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump.
−Removed: We anticipate that t:sport will feature a 200-unit cartridge, an on-pump bolus button, a rechargeable battery, an AID algorithm, a Bluetooth radio, and a dedicated controller option.
−Removed: t:sport is being designed for use with leading U-100 insulins, and we are evaluating the use of insulin concentrates for people with greater insulin needs.
−Removed: The t:sport pumping mechanism differs from our current micro-delivery technology used in the t:slim pump platform.
−Removed: t:sport Shown with Mobile App Controller
−Removed: AID System Evolution
−Removed: We are evolving our AID technology to provide users greater clinical benefit, with fewer direct interactions required on a pathway to a fully closed-loop AID system.
−Removed: We are building upon our Control-IQ technology, the most advanced commercially available AID system, and intend to deliver new features and benefits to our customers on a regular basis.
−Removed: In addition to algorithm enhancements intended to improve clinical outcomes, we are also developing new features for greater personalization and refinements to the overall system usability.
−Removed: Digital Health Offerings
−Removed: Our digital health offerings are being developed to enhance our ecosystem of products and services, and integrate our insulin therapy management systems with consumer electronics technology.
−Removed: Today, we offer individual applications through the web, such as our t:connect patient and HCP portals, through mobile via our t:connect and Sugarmate apps, and through the PC with the Tandem Device Updater.
−Removed: In the fourth quarter of 2020, we submitted a 510(k) application to the FDA for use of our mobile app in the remote delivery of bolus insulin and are preparing for launch in the United States in the first half of 2021.
−Removed: Future updates of our mobile application are planned to include additional pump control features and integrate other health-related information from third-party sources.
−Removed: We plan to transition several of our discrete digital offerings to a single, global digital platform, which is intended to provide all users, including pump users, caregivers and healthcare providers, with a simplified and tailored user experience.
−Removed: This platform is being developed to support pump viewing, control, and reporting, as well as a mobile store through which users can learn about and shop for our products, and in the future we hope to include new customer onboarding, training and support.
−Removed: The platform is also being designed to enhance the user experience, streamline the pump and supplies purchasing process, and provide internal efficiencies.
−Removed: Data from our centralized system will be used for new product development, continuous product improvement, and for the generation of health economic outcomes data, and may ultimately support artificial intelligence and patient monitoring services.
−Removed: We intend to launch the first element of this new platform under the name Tandem Source.
−Removed: Tandem Source is our second generation data management application that we intend to first offer outside the United States.
−Removed: It is a customizable dashboard designed to deliver the data and insights needed to expertly manage diabetes.
−Removed: With Tandem Source, healthcare providers and people living with diabetes have a trusted and reliable destination to review and analyze pump performance over time.
−Removed: Tandem Source’s data visualization and customization options will offer healthcare providers better tools to identify trends that can help them make educated, data-driven decisions.
−Removed: We intend to commence a scaled launch of Tandem Source in select countries outside the United States beginning in the second half of 2021, and once globally available, it will ultimately replace t:connect.
−Removed: Adding and Enhancing System Components
−Removed: Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complimentary system components.
−Removed: This includes integration with CGM, expansion of insulin administration and infusion set technology, and the use of alternative insulins.
+Added: 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.
+Added: Our product development efforts fall into three pillars of innovation:
+Added: delivery devices, device software including algorithms, and data and insights.
+Added: Delivery Devices
+Added: We are developing a family of delivery device solutions to meet the varying needs of people living with type 1 and type 2 diabetes by providing choice within our own portfolio.
+Added: 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.
+Added: 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.
+Added: Its features include a 200-unit cartridge, an on-pump bolus button, inductive charging, an AID algorithm, and is waterproof.
+Added: We anticipate that Mobi will be our first insulin pump to support full pump-control from our mobile application.
+Added: 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.
+Added: It is also being designed to include enhanced technology, such as greater processing power and capacity to support our advanced algorithms, as well as increased battery life, improved durability, and wireless software update capabilities.
+Added: This offering is being developed to provide an alternative tubeless infusion site option for Mobi pump users.
+Added: 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.
+Added: 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: Device Software
+Added: Our device software is used to control our pumps either directly through the pump’s interface or through our mobile application.
+Added: It also includes our AID technology, and the software used to support remote pump updatability.
+Added: Control-IQ Technology Advancements
+Added: 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.
+Added: 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: We are also researching the use of different insulins with our Control-IQ technology.
+Added: Mobile Control
+Added: We are working to expand our mobile control capability.
+Added: In the future, our t:connect mobile app is planned to include additional pump control features, such as full operation of our Mobi pump.
+Added: Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complementary system components.
In November 2020, we entered into an agreement with Dexcom to extend our current collaboration to include integration with their future G7 CGM technology.
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and Canada, with additional geographies considered in the future.
+Added: Data and Insights
+Added: 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.
+Added: 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.
+Added: 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: Tandem Source
+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 become our single, global platform.
+Added: 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.
+Added: In the second quarter of 2021, we began limited testing of an initial version of Tandem Source in the United Kingdom.
+Added: We continue to develop and test new features for Tandem Source in anticipation of a future commercial release of the product.
+Added: Settings Automation
+Added: Our automation research and development activities center around opportunities for enhanced user and healthcare provider experience, and improved clinical outcomes.
+Added: 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.
Sales, Marketing and Customer Care
In 2021, our U.S.
−Removed: sales organization was comprised of approximately 90 territories.
−Removed: The vast majority of these territories are supported by a sales representative and a clinical diabetes specialist who, as a team, call on domestic endocrinologists, nurse practitioners, primary care physicians, certified diabetes educators and potential customers.
+Added: sales organization was comprised of approximately 95 territories, which we began expanding to approximately 110 territories at the end of the year.
+Added: 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.
Where appropriate, some territories are supported by multiple clinical diabetes specialists.
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Our internal customer sales support organization also contacts existing customers who are approaching their insurance renewal date to aid in the renewal process.
−Removed: Our goal is for at least 70% of our existing customers to purchase a new pump from us when making their next pump purchasing decision.
−Removed: Typically, domestic customers are eligible for insurance reimbursement to purchase a new insulin pump once every four years;
+Added: Typically, customers are eligible for insurance reimbursement to purchase a new insulin pump once every four years;
however, some plans may be limited to once every five years or have additional restrictions or requirements.
Insurance reimbursement processes outside the United States vary by geography.
−Removed: As our market penetration continues to build momentum, and as we launch new products into the market, we plan to further expand our sales, clinical and marketing infrastructure in the United States.
−Removed: However, only modest territory optimizations and expansions are planned in 2021.
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: Following Health Canada approval, we commenced marketing and sales efforts of the t:slim X2 with G5 integration in October 2018, and for the t:slim X2 with Basal-IQ technology in November 2019.
−Removed: In December 2020, Health Canada approved the t:slim X2 with Control-IQ technology, which we anticipate commercializing in the first quarter of 2021.
−Removed: In other select geographies outside the United States, our initial efforts focused on the identification and contracting of distributors in areas where we believe there is a meaningful opportunity to achieve market acceptance of our t:slim X2 insulin pump.
−Removed: We began our scaled launch in the third quarter of 2018 after obtaining the right to affix the CE Mark to the t:slim X2 with G5 integration and following the completion of pre-launch activities, such as translating our pump software and user manual, and completing distributor sales and customer service trainings.
−Removed: Unlike our domestic operations, our international distributors (other than in Canada) have substantially greater responsibility for sales, marketing and customer support efforts.
−Removed: As of the end of 2020, our international distributors covered nearly 20 countries.
−Removed: In 2021, we anticipate our international distributor coverage will expand to approximately 25 countries.
+Added: 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.
+Added: 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.
+Added: 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.
Revenue Concentrations and Significant Customers.
−Removed: A small number of independent domestic distributors have historically accounted for a significant portion of our revenues.
+Added: A small number of independent distributors in the United States have historically accounted for a significant portion of our revenues.
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, 2020, sales to our two largest distributors accounted for 15.9% and 12.9% of consolidated sales, respectively.
−Removed: During the year ended December 31, 2019, sales to our two largest distributors accounted for 14.8% and 15.4% of consolidated sales, respectively.
+Added: During the year ended December 31, 2021, sales to our two largest distributors accounted for a combined 21.5% of consolidated sales.
+Added: During the year ended December 31, 2020, sales to our two largest distributors accounted for a combined 28.8% of consolidated sales.
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.
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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.
−Removed: In October 2017, Johnson & Johnson announced that it was discontinuing the operations of Animas, and exiting the insulin pump business entirely, and, in connection with these activities, designated Medtronic as a preferred partner to facilitate the transition of Animas insulin pump customers.
−Removed: Throughout 2018 and 2019 we experienced an increase in our percentage of sales to people who reported converting from using an Animas pump.
−Removed: Animas pump supplies were no longer available for customers to purchase after September 2019.
−Removed: Accordingly, we believe that the vast majority of Animas pump users transitioned to an alternative pump by the end of 2019.
−Removed: Outside the United States, many of our international distributors had existing relationships with Animas customers and were motivated to keep those individuals as existing customers by replacing Animas pumps with our t:slim X2 as opportunities arose.
−Removed: We believe the benefit from the Animas opportunity outside the U.S.
−Removed: was substantially realized by end of the second quarter of 2019.
Training and Customer Care .
−Removed: Our customer care infrastructure, which services the United States and Canada, consists of individuals focused on training, insurance verification and 24/7 technical services.
−Removed: Our goal is to offer best-in-class customer support and services as these offerings are often viewed by people with diabetes and their healthcare providers equally as important as the products we offer.
−Removed: In 2019, we opened a facility in Boise, Idaho to begin scaling our customer care organization outside of San Diego.
−Removed: This has allowed us to hire talented service employees more quickly than we would have been able to in San Diego at a lower cost of operations, which provides further leverage to our infrastructure.
−Removed: During 2021 we expect to further expand our customer care infrastructure, including investments in technology and personnel, to meet the needs of our larger base of in-warranty customers.
−Removed: We also provide training to our distribution partners who fulfill their customer care responsibilities outside the United States.
+Added: In the United States and Canada, our customer care infrastructure consists of specialists focused on product training, pump and supply order processing and 24/7/365 technical services.
+Added: We also provide training and technical services to our distribution partners who fulfill their customer care responsibilities outside the United States.
+Added: 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
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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 cartridges have remained relatively unchanged.
−Removed: Domestically, 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.
+Added: Over the last ten years, Medicare reimbursement rates for insulin pumps and disposable insulin cartridges have increased modestly.
+Added: 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.
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.
−Removed: We enter into contracts with national and regional third-party payors to establish reimbursement for our insulin pump products, disposable cartridges and other related supplies.
+Added: 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.
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: In July 2020, we were named as a network provider by UnitedHealthcare.
−Removed: From July 2016 to June 2020, only a small subset of UnitedHealthcare’s members were able to obtain reimbursement for our products, primarily select pediatric and government plan members.
+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 utilize distribution channels so our customers’ orders can be serviced.
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: If we are not contracted with a person’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: As of December 31, 2020, we had executed distributor agreements with approximately 43 independent distributors in the United States.
−Removed: In most cases, but not all, this network of distributors allows us to access people who are covered by commercial payors with whom we are not contracted, at in-network rates that are generally more affordable for our customers.
+Added: As of December 31, 2021, our distribution channel was comprised of approximately 44 independent distributors.
+Added: 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.
+Added: The most significant exception was in the period from July 2016 to June 2020.
+Added: 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.
+Added: In July 2020, we were named as a network provider by UnitedHealthcare.
Our distribution partners outside the United States and Canada are responsible for all reimbursement, tender application and fulfillment activities.
Manufacturing and Quality Assurance
−Removed: Historically, we have manufactured our pump and disposable cartridge products at our Barnes Canyon facility in San Diego, California.
−Removed: In 2020, we began outsourcing a portion of our cartridge manufacturing to an experienced third-party contract manufacturer to provide us additional flexibility in scaling our business while creating additional leverage.
−Removed: In 2019, we made capital expenditure investments for the expansion of warehousing capacity and ordered additional manufacturing equipment that was implemented in 2020.
−Removed: These investments allowed us to double our cartridge manufacturing capacity from 2019 to 2020, without meaningfully increasing the cost of overhead associated with our manufacturing facilities.
−Removed: We believe these investments position us well to achieve our long-term gross margin targets.
−Removed: We currently utilize a semi-automated manufacturing process for our pump products and disposable cartridges.
−Removed: A single pump production line reaches a maximum output of approximately 30,000 pumps per year on a single shift and we currently have the capacity to produce approximately 180,000 pumps annually.
−Removed: Disposable cartridges are manufactured on a production line that reaches a maximum output of approximately one million cartridges per year on a single standard eight-hour shift.
−Removed: Throughout 2020, we scaled our cartridge capacity at our third-party manufacturing location and now have capacity to produce up to approximately 33 million cartridges annually to support an installed base of more than 275,000 customers.
−Removed: Outside suppliers are the source for most of the components and some sub-assemblies in the production of our insulin pumps.
+Added: Our pump products are currently assembled, tested and packaged at our facilities in San Diego, California.
+Added: Prior to 2020, we manufactured and tested our disposable cartridge products at our Barnes Canyon facility in San Diego, California.
+Added: 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.
+Added: We also utilize external third parties for sterilization of our finished cartridges.
+Added: All finished cartridges are packaged for sale at our facilities in San Diego.
+Added: Outside suppliers are the source for components and some sub-assemblies in the production of our insulin pumps and cartridges.
+Added: In addition, we purchase all of our currently marketed infusion sets from a third party supplier, Unomedical A/S, a subsidiary of ConvaTec Group.
+Added: Unomedical is responsible for all manufacturing, testing, sterilization and packaging of the infusion sets under our brands.
Any sole and single source supplier is managed through our supplier management program that is focused on reducing supply chain risk.
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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.
+Added: We follow and comply with a comprehensive set of quality certifications and standards.
+Added: 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.
+Added: 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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Research and Development
−Removed: Our research and development team includes employees who specialize in software engineering, mechanical engineering, electrical engineering, and user experience design, many of whom have considerable experience developing diabetes-related products.
+Added: 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.
Our research and development team focuses on the continuous improvement and support of current product offerings, as well as our products under development.
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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 have 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.
+Added: 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.
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.
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patents expire between approximately 2022 and 2040.
−Removed: We are also seeking patent protection for our proprietary technology in other countries throughout the world.
+Added: Our foreign patent portfolio consisted of approximately 41 issued patents and 15 pending patent applications in other countries throughout the world.
+Added: Of these, our issued foreign patents expire between approximately 2025 and 2036.
In addition, we also have 94 trademark registrations, including 18 U.S.
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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: We agreed to pay $5.0 million in license fees and to share equally any associated sublicense revenues we may receive.
−Removed: As of December 31, 2020, we had paid the initial license fees in full and have not entered into any sublicense agreements.
−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.
+Added: 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).
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.
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 domestic and international markets with a number of companies that manufacture insulin delivery devices, such as Medtronic MiniMed, a division of Medtronic, and Insulet Corporation.
+Added: 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).
In addition, Eli Lilly & Co.
−Removed: has announced a collaboration to commercialize a version of Ypsomed AG’s existing insulin pump as part of a to-be-developed system.
+Added: (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.
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.
market, including insulin pumps and Bluetooth-enabled insulin pens to support MDI therapy.
−Removed: Additionally, several other companies currently market insulin pump products in international markets.
+Added: Additionally, several other companies currently market insulin pump products in markets outside the U.S.
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.
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Clinical trials are typically required to support a PMA application and are sometimes required for a 510(k) clearance.
+Added: We anticipate that most of our future AID offerings will require supporting clinical data, either from clinical trials or potentially from evidence that we are able to collect through real-world use of our products.
These trials generally require submission of an application for an Investigational Device Exemption (IDE), to the FDA.
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• the FDA concludes that our trial design is inadequate to demonstrate safety and efficacy.
+Added: We are currently sponsoring or supporting several clinical trials that are intended to support future enhancements to our AID products.
Other Regulatory Requirements.
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There are numerous U.S.
−Removed: federal and state laws pertaining to healthcare fraud and abuse, including the federal Anti-Kickback Statute and the Physician Self-Referral Law (the Stark Law), the federal civil False Claims Acts, the federal criminal Health Care Fraud Statute, as well as various state laws regulating healthcare.
+Added: federal and state laws pertaining to healthcare fraud and abuse, including the federal Anti-Kickback Statute and the Physician Self-Referral Law (the Stark Law), the federal civil False Claims Act, the federal criminal Health Care Fraud Statute, as well as various state laws regulating healthcare.
Our relationships with healthcare providers and other third parties are subject to scrutiny under these laws.
−Removed: Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Administration health programs.
−Removed: Federal Anti-Kickback Statue.
+Added: Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state healthcare programs, including the Medicare, Medicaid and Veterans Health Administration programs.
+Added: Federal Anti-Kickback Statute.
The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or the furnishing, recommending, or arranging of a good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid.
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We believe we are in substantial compliance with the Physician Payments Sunshine Act to date.
−Removed: However, the reporting requirements are meaningfully expanded beginning in 2021 and we will need to implement additional processes and controls in order to comply with these new tracking and disclosure obligations.
+Added: However, the reporting requirements were meaningfully expanded beginning in 2021 and we implemented additional processes and controls in order to comply with these new tracking and disclosure obligations.
Anti-Bribery and Anti-Corruption Laws.
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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 Brexit and the United Kingdom’s (UK) exit from the European Economic Area, the UK is not scheduled to transition to the Medical Device Regulation but will continue to operate under existing directives.
+Added: 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.
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.
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Information Security
+Added: We have implemented, and continually improved, an Information Security Program that was developed to secure our non-public information, systems, networks, databases, and workstations.
+Added: 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.
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.
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Environmental Impact and Sustainability
−Removed: In 2020, we expanded the number of employees in our environmental, health and safety department and added leadership who bring experience from companies larger and more established than ours.
−Removed: We have a focused effort on understanding the environmental impact of our business and have a number of initiatives in place to support this effort.
+Added: 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.
+Added: 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.
+Added: As an employer and manufacturer, we are mindful of the impact our facilities and employee transportation have on the environment.
+Added: 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.
+Added: This building is certified under the
+Added: 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.
+Added: 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.
+Added: 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.
+Added: This helps to reduce carbon emissions associated with employees commuting to our facility on a daily basis.
+Added: 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).
+Added: In addition, we have initiatives in place in support of monitoring and reducing our environmental impact.
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.
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We are also working to reduce landfill waste by baling and recycling our cardboard, and we have a commingled recycling program in place.
+Added: The environmental impact of consumer use of our product offerings is also a focus for our company.
+Added: This starts with innovation in our product design.
+Added: The t:slim X2 has two key environmental design features that are a competitive advantage:
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.
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: Also, our Tandem Device Updater enables our insulin pumps to be remotely updated with new pump software and features, thereby avoiding the environmental effects of physically producing, shipping, exchanging, and disposing of hardware.
−Removed: Since August 2017, over 100,000 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: In addition, we have reduced the size of our cartridge pouch so that it uses less packaging material.
+Added: 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.
+Added: 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.
+Added: In addition, we utilize a refurbishment program that allows for the use of key components thereby reducing electronic waste.
+Added: We are also mindful of the environmental impact of our supply chain efforts.
+Added: For example, we utilize sea freight for a majority of our international shipments, which has lower emissions than road or air.
+Added: We also use electronic forklifts and repeat pallet use in our warehouse operations.
+Added: Our third party logistics provider, Omni, signed the Climate Pledge in Q3 2021 committing to net zero carbon by 2040.
+Added: 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.
+Added: We also receive annual conflict mineral disclosure from our suppliers.
We continue to use innovative techniques to reduce environmental impact and deliver products that can change people’s lives.
+Added: 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.
+Added: 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.
Community Outreach and Impact
We strive to be a good corporate citizen in the communities in which our employees live and work.
−Removed: Our employee community outreach efforts include donations and volunteer work, serving on boards and advisory committees and other corporate and individual actions.
−Removed: In 2020, we extended our employee giving campaigns to include support for PRIDE organizations in San Diego and Boise.
−Removed: We partnered with Athena, a women’s advocacy organization in San Diego, offering membership to 15 of our employees, giving them access to Athena’s network and benefits.
−Removed: We championed employee participation in the annual Spare a Rose campaign, with funds going to Life For a Child, and continued our annual employee fundraising campaign for the JDRF San Diego One Walk in support of diabetes research.
−Removed: In 2020, we joined JDRF as a national partner, supporting their events nationally at a higher level than ever before.
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 Beyond type 1, Connected in Motion, Riding on Insulin, College Diabetes Network, Diabetes Exercise and Camping Association, Touched by Type 1, and regional diabetes events such as Children with Diabetes, Taking Control of Your Diabetes, American Diabetes Association, and camps where our employees participate and volunteer.
+Added: 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.
+Added: Our employee community outreach efforts include donations and volunteer work, serving on boards and advisory committees and other corporate and individual actions.
+Added: Examples of our corporate giving efforts include:
+Added: • 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.
+Added: • JDRF annual employee fundraising campaign in support of diabetes research.
+Added: • Athena sponsorships in support of women in STEM leadership in San Diego, including the Lifting While Climbing Summit and “Clinical Trial Diversity:
+Added: Closing the Gap to Achieve Health Equity” event.
+Added: • 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.
+Added: • Diabetes Camp Partnerships with Camp Conrad Chinnock and Camp Kudzu that specifically support underserved communities.
+Added: • Spare a Rose campaign in support of Life For a Child which provides under-resourced countries with insulin, supplies and diabetes education.
Human Capital
+Added: 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.
As of December 31, 2021, we had approximately 2,000 regular full-time employees, all of whom work in the United States or Canada.
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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 an office in Markham, Ontario, Canada.
+Added: 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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Fostering and maintaining a strong, healthy culture is a key strategic focus.
−Removed: In 2020, the San Diego Business Journal named us as “One of the Best Places to Work” in San Diego, an award given to “outstanding companies whose benefits, policies and practices are among the best in the region”.
−Removed: We were also ranked 6th as one of the “Best Places to Work in Idaho” for a company of our size of operations in the state.
−Removed: Our core values statement was created by our employees in a bottom-up, cross-functional process.
−Removed: These core values reflect who we are and the way our employees interact with one another, our customers, partners and stockholders.
−Removed: Innovate, for real 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.
+Added: Our core values statement was created by our employees in a bottom-up, cross-functional process that we revisit and refresh on a periodic basis.
+Added: 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.
+Added: 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.
No Shortcuts is holding ourselves to the highest ethical standards and delivering exceptional quality.
−Removed: Huddle up highlights the importance of successful collaboration that is inclusive of diverse perspectives, both inside and outside of the Company.
+Added: Team Up highlights the importance of successful collaboration that is inclusive of diverse perspectives, both inside and outside of the Company.
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: Don’t mess with our customers emphasizes the deep care we have for the people who use our products, their loved ones and health care providers.
+Added: People First emphasizes the deep care we have for the people who use our products, their loved ones and health care providers.
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.
+Added: In 2021, we conducted our first employee engagement survey through Gallup, a leading global consulting firm on employee engagement.
+Added: 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: 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.
We have detailed ethics and compliance policies that instill a commitment to ethical behavior and legal compliance across our company.
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Employees are also able to make confidential and anonymous reports using an online or telephone hotline hosted by a third party provider.
−Removed: Diversity and Inclusion
+Added: Diversity, Equity and Inclusion
+Added: 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.
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.
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.
−Removed: We believe that bringing together different perspectives and experiences is fundamental to innovation and continue raising the bar in the field of diabetes technology.
−Removed: In 2020, we formed a diversity and inclusion council, sponsored by executive management, which is staffed by employees with diverse backgrounds, experiences or characteristics who share a common interest in professional development, improving corporate culture and delivering sustained business results.
−Removed: This council is 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.
+Added: 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.
+Added: 2021 was our first full year of having a DE&I Council.
+Added: This Council is sponsored by executive management and we provide regular updates to our Board of Directors on its initiatives and progress.
+Added: It is staffed by employees with diverse backgrounds, experiences or characteristics who share a common interest in professional development, improving corporate culture and delivering sustained business results.
+Added: Our DE&I efforts are focused on diabetes representation and access, representation in leadership, representation in technology roles and pro-inclusion.
+Added: 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.
+Added: Many of our community outreach and impact efforts are focused on support for diversity-related causes.
+Added: 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.
+Added: 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: 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.
+Added: 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.
+Added: 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.
We leverage both formal and informal programs to identify, foster, and retain top talent at both the corporate and operating level.
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More than 90% of employees participating in these programs remain employed at Tandem and approximately one-third have been promoted or have had a significant change in scope of responsibility.
+Added: In 2021, more than 150 employees participated in our leadership development programs.
+Added: 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.
Our leadership team also mentors rising talent on a more informal basis.
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Also, our employees are able to participate in our employee stock purchase program.
−Removed: 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 and life, disability/accident coverage and a wellness program.
−Removed: In addition, we engage a nationally recognized outside compensation and benefits consulting firm to independently evaluate the effectiveness of our executive compensation and total rewards programs and to provide benchmarking against our peers within the industry.
+Added: 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.
+Added: 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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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: Also, we have comprehensive safety training programs that ensure our employees know how to do their jobs safely and in compliance with laws and regulations.
+Added: In 2021, we implemented safety management software to better manage safety inspections, assessments, and safety data sheets.
+Added: We have comprehensive safety training programs that ensure our employees know how to do their jobs safely and in compliance with laws and regulations.
We operate in modern, efficient, and safe facilities, and have had minimal accident and injury rates company-wide.
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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.
−Removed: Our response to the COVID-19 pandemic also included employee safety measures such as:
−Removed: • Adding work from home flexibility;
−Removed: • Increasing cleaning protocols across all locations;
−Removed: • Initiating regular communication regarding impacts of the COVID-19 pandemic, including health and safety protocols and procedures;
−Removed: • Implementing temperature screening of employees at the majority of our manufacturing and warehousing facilities;
−Removed: • Establishing new physical distancing procedures for employees who need to be onsite;
−Removed: • Providing additional personal protective equipment and cleaning supplies;
−Removed: • Implementing protocols to address actual and suspected COVID-19 cases and potential exposure;
−Removed: • Limiting domestic and international non-essential travel for all employees;
−Removed: • Requiring masks to be worn in all locations where mandated by local law.
+Added: As such, we have invested in creating physically safe work environments for our employees through the implementation of new protocols, trainings and communications.
COVID-19 Global Pandemic Impact and Considerations
−Removed: We are 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: We experienced a modest impact from the COVID-19 global pandemic during the first quarter of 2020, which became more pronounced beginning in the second quarter through the end of the year.
−Removed: We originally anticipated that our sales outside the United States would experience a greater proportional impact due to differences in the sales process in domestic versus international markets.
−Removed: Initially, the impact on our business was relatively consistent worldwide but we have since seen varying degrees of impact in international markets based on local conditions.
−Removed: We anticipate that our sales and operating results will continue to be adversely impacted and subject to unpredictable variability for the duration of the pandemic.
−Removed: For example, we have experienced delays in certain programs of up to three or six months from when they were originally planned, such as human factors studies associated with our product development efforts.
−Removed: In addition, regulatory timelines may be difficult to predict as the FDA has stated that its review process may take longer than normal due to the impact of the COVID-19 global pandemic.
−Removed: The full extent of the impact of the COVID-19 global 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: We have taken steps to prioritize the health and safety of our employees and customers during the COVID-19 global pandemic, while working to maintain a continuous supply of products, training and customer support.
−Removed: To that end, we have increased the frequency of our communications to employees, suppliers, customers, and healthcare providers.
−Removed: Since March 2020, we have restricted non-essential employee travel, banned visitors from all of our facilities, and transitioned those employees able to perform their job function outside of our facilities to a remote work environment.
−Removed: For our field-based sales and clinical employees, we initially discontinued all in-person activities and began utilizing technology to remotely engage healthcare providers and customers.
−Removed: We continue to work closely with our healthcare providers and customers, remaining flexible in our method of interaction.
−Removed: To help ensure the safety and health of our employees in manufacturing and warehousing positions involved in production and fulfillment operations, we have implemented preventative measures to comply with social distancing requirements and require temperature checks of our employees before each shift.
−Removed: In response to developments surrounding the COVID-19 global pandemic, we initiated discussions with our key suppliers in early 2020 regarding their abilities to fulfill existing orders, and we have continued to regularly assess their capacity.
−Removed: During the first six months of 2020, we experienced certain challenges managing our inventory, primarily due to the impacts of the COVID-19 global pandemic.
−Removed: For example, in the first quarter of 2020, we observed customers purchasing cartridges and infusion sets at a higher rate than anticipated.
−Removed: In addition, during the second quarter of 2020, our infusion set manufacturer experienced certain inventory constraints which resulted in us requesting some customers to accept substitutions of similar products to prevent delays in order fulfillment.
−Removed: At this time, we believe many of our suppliers are deemed essential businesses under applicable governmental orders, and we have not experienced, and do not anticipate experiencing, disruption in our ability to manufacture insulin pumps and cartridges due to component procurement limitations.
−Removed: Additionally, our third-party cartridge manufacturer completed validation and commenced commercial-scale manufacturing near the end of the first quarter to supplement our existing cartridge manufacturing capacity, which we believe will assist us in meeting product demand in future periods.
−Removed: Our finished goods and raw material inventory, as well as available manufacturing capacity, position us well to respond to unforeseen disruptions in the near term.
−Removed: Commercially, we have been communicating with our customers and healthcare providers through social media, direct email outreach and our website, in addition to regular communications sent by our sales and clinical employees.
−Removed: We are also leveraging our technology platforms, such as our t:connect diabetes management application, to support healthcare providers, as many of them are increasingly utilizing telehealth capabilities in their practices.
−Removed: By the end of the first quarter of 2020, we expanded our remote new pump training offering to all customers who purchased a t:slim X2 insulin pump, and in the third quarter, we resumed offering in-person trainings on a limited basis and under specific conditions.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Most notably, our sales results reflected a high degree of variability across the quarters during this time, unlike historical seasonal trends.
+Added: We experienced a modest impact early in 2020, which became more pronounced and continued in varying degrees as the pandemic progressed.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: In early 2020, we initiated regular discussions with our key suppliers regarding their abilities to fulfill existing orders and assess their ongoing capacity.
+Added: Over the course of the pandemic, we have increased the frequency of those communications.
+Added: 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.
+Added: We anticipate experiencing continued challenges managing supply chain constraints, including the potential for limitations on availability of components as well as increased purchase costs.
+Added: Generally, our entire operation has been impacted as we navigate the generalized labor shortages impacting global markets.
+Added: 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.
+Added: In particular, these labor challenges combined with regulatory delays have impacted our product development and launch timelines.
+Added: The FDA has generally stated that its review process may take longer than normal due to prioritization of COVID-related products and services.
+Added: We have experienced lengthy delays in the review of pending submissions with the FDA, making regulatory timelines increasingly difficult to predict.
+Added: We have adapted well in our commercial operations and customer-facing functions.
+Added: Our sales organization balances remote and in-person interactions based on the needs and requirements of the customers with whom they interact.
+Added: For example, prior to the onset of the pandemic, nearly all trainings for customers purchasing our pump platform were in-person.
+Added: We quickly pivoted to nearly all trainings being provided on remote platforms.
+Added: Since that time, we have achieved a balance that includes options for the individual based on their unique needs.
+Added: We continue to see variability across the markets in which we operate and anticipate these fluctuations between in-person and remote interactions will continue.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Overall, we anticipate that our sales and operating results will continue to be impacted and subject to unpredictable variability.
+Added: 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.
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.
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from Boston University.
−Removed: Berger (age 51) has served as our Executive Vice President, Chief Business Operations and Compliance Officer since November 2020 and is responsible for the Company’s legal, quality, regulatory, clinical and customer technical support functions.
−Removed: He previously served as Executive Vice President, Chief Legal and Compliance Officer since April 2019, and as General Counsel, having overseen the legal department since August 2013.
+Added: 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.
+Added: 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.
From January 2008 until August 2013, Mr.
Berger was employed at Senomyx, Inc., a taste science company, where he most recently served as Senior Vice President and General Counsel.
−Removed: He also served as Corporate Secretary of Senomyx from January 2008 until May 2014.
From April 2003 until October 2007, Mr.
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from Stanford Law School.
−Removed: Hansen (age 53) has served as our Executive Vice President and Chief Commercial Officer since February 2016.
+Added: Carpenter (age 58) has served as our Chief Technical Officer since November 2021.
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.
+Added: 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.
+Added: 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.
+Added: Prior to that, from May 2009 until March 2017, Mr.
+Added: Carpenter served as the Senior Vice President of Engineering at Smith Micro Software.
+Added: Earlier in his career, he held various engineering development and leadership roles at Nextwave Wireless, Sierra Wireless, General Dynamics, Motorola and Denso.
+Added: 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.
Gasser (age 46) has served as our Executive Vice President, Strategy and Corporate Development since January 2020.
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in Economics from the University of Cambridge.
−Removed: Morrison (age 41) 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, project management, human resources and facilities functions.
+Added: Hansen (age 54) has served as our Executive Vice President and Chief Commercial Officer since February 2016.
+Added: Prior to joining our company, Mr.
+Added: Hansen served from September 2014 as Chief Commercial Officer of Adaptive Biotechnologies Corp.
+Added: From May 2013 to September 2014, Mr.
+Added: Hansen served as Head of Commercial, Sales and Marketing, of Genoptix, a Novartis Company.
+Added: 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.
+Added: Hansen received a B.S.
+Added: in Business Administration from the University of Missouri-Columbia, and an M.B.A.
+Added: from the School of Business at San Diego State University.
+Added: 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.
+Added: Before joining our Company, Ms.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Hansen holds a BS in Chemical Engineering from Carnegie Mellon University, and a JD from Stanford Law School.
+Added: James Leal (age 58) has served as our Senior Vice President, Operations since August, 2017.
+Added: Leal joined Tandem in October 2010 as Vice President, Operations.
+Added: Previously, Dr.
+Added: Leal was the Vice President of Manufacturing and Field Support for Volcano Corporation and held Director Roles with CardioNet, Inc.
+Added: and Digirad Corporation.
+Added: He held Senior Engineering roles with FlipChip Technologies and Hughes Aircraft Company.
+Added: 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.
+Added: Leal is a University of Arizona graduate with a B.S.
+Added: in Metallurgical Engineering, and both a M.S.
+Added: and a PhD in Materials Science and Engineering.
+Added: 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.
From April 2013 until September 2013, she served as our Vice President, Human Resources, Corporate and Investor Relations.
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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.