−Removed: We are a medical device company with an innovative approach to the design, development and commercialization of products for people with insulin-dependent diabetes.
+Added: 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.
+Added: Diabetes management can vary greatly person-to-person, creating multiple market segments based on clinical needs and personal preferences.
+Added: 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.
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.
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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: The simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available.
−Removed: It is the only pump currently available in the United States that is capable of remote feature updates, which positions us well to address the evolving needs and preferences of differentiated segments of the insulin-dependent diabetes market.
−Removed: We aim to improve and simplify the lives of people with diabetes and those of their healthcare providers, by delivering innovative hardware and software solutions, as well as best-in-class customer support.
Since our initial commercial launch, we have been able to rapidly innovate and bring more products to market than our competitors.
−Removed: We have commercially launched seven insulin pumps in the United States since 2012 and two pumps outside the United States since 2018.
−Removed: Four of our insulin pumps have featured integration with continuous glucose monitoring (CGM) technology, and two have featured an automated insulin delivery (AID) algorithm.
−Removed: We believe that the three new classifications defined by the United States Food and Drug Administration (FDA) for the interoperability of devices for AID will help support continued rapid innovation by streamlining the regulatory pathway for integrated products.
−Removed: In June 2018, the t:slim X2 was the first insulin pump designated as compatible with integrated continuous glucose monitoring (known as iCGM) devices;
−Removed: in February 2019, the t:slim X2 was the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps);
−Removed: and in December 2019, Control-IQ technology for the t:slim X2 insulin pump was the first automated insulin dosing software in a new interoperable automated glycemic controller category.
−Removed: Today, our t:slim X2 hardware platform represents 100% of our new pump shipments.
−Removed: It is the only commercial insulin pump that allows users to update their pumps’ software quickly and easily from a personal computer.
−Removed: We have offered in-warranty t:slim customers in the United States four different software updates for no-cost using the Tandem Device Updater, including our two AID algorithms, Basal-IQ technology and Control-IQ technology.
+Added: 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.
+Added: Today, our software-updatable t:slim X2 hardware platform represents 100% of our new pump shipments.
+Added: Our simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available.
+Added: We have commercially offered our pump technology integrated with three generations of Dexcom’s continuous glucose monitoring (CGM) sensors.
+Added: The t:slim X2 is the only pump on which remote software updates have been commercially available in the United States.
+Added: This experience, which offers and supports different software updates, provides us with a unique competitive advantage.
+Added: Two of our updates provided our users access to our automated insulin delivery (AID) algorithms, Basal-IQ technology and Control-IQ technology.
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.
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 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 intend to begin offering Control-IQ technology updates in select geographies in the second half of 2020.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: We continue to offer both AID algorithms on the market to support the varying needs of people living with diabetes.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
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.
−Removed: In the four-year period ended December 31, 2019, we shipped approximately 142,000 insulin pumps, which is representative of our estimated global installed customer base on the typical four-year reimbursement cycle.
−Removed: Approximately 118,000 of these pumps were shipped to customers in the United States and approximately 24,000 were shipped to international markets.
−Removed: For the years ended December 31, 2019 , 2018 and 2017 , our consolidated sales were $ 362.3 million, $ 183.9 million, and $ 107.6 million, respectively.
−Removed: For the years ended December 31, 2019 , 2018 and 2017 , our net loss was $ 24.8 million, $ 122.6 million, and $ 73.0 million, respectively.
−Removed: Worldwide pump sales accounted for 68% , 67% , and 66% of our total sales, respectively, for the years ended December 31, 2019 , 2018 and 2017 , while pump-related supplies and accessories accounted for the remainder in each year.
−Removed: Our accumulated deficit as of December 31, 2019 and December 31, 2018 was $ 624.8 million and $ 600.1 million, respectively.
−Removed: This included $216.6 million and $147.4 million of non-cash stock-based compensation charges and non-cash changes in the fair value of common stock warrants as of December 31, 2019 and 2018 , respectively.
−Removed: Our headquarters and our manufacturing facility are located in San Diego, California.
−Removed: We also have an office in Boise, Idaho.
−Removed: We employed 1,043 full-time employees as of December 31, 2019 .
+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, as well as a variety of accessories designed for enhanced usability.
+Added: 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.
+Added: 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: Our primary research and development and administrative headquarters are located in San Diego, California.
+Added: We also operate a manufacturing facility and a warehousing facility in San Diego.
+Added: In addition, we maintain offices in Boise, Idaho and in Markham, Ontario, Canada.
+Added: We employed approximately 1,500 regular full-time employees as of December 31, 2020.
Diabetes and the Insulin Therapy Management Market
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• Type 2 diabetes represents 90% to 95% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce enough insulin.
−Removed: Initially, many people with type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise and oral medications.
−Removed: However, as their diabetes advances, some patients progress to requiring injectable therapies, such as long-acting insulin, and a subset of this population will require daily rapid-acting insulin therapy.
−Removed: The International Diabetes Federation estimates that 463 million people have diabetes worldwide, approximately half of which are undiagnosed.
+Added: Initially, many people with type 2 diabetes often attempt to manage their diabetes with improvements in diet and exercise, and with oral medications.
+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 daily rapid-acting insulin therapy.
+Added: 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: In addition, approximately 1.1 million children and adolescents had type 1 diabetes, and nearly 130,000 people under age 20 are estimated to be diagnosed annually.
In the United States, the Centers for Disease Control and Prevention estimates that in 2020 approximately 34 million people were living with diabetes of which approximately 27 million had diagnosed diabetes.
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Estimated Diagnosed Diabetes Prevalence (1)
−Removed: Type 2 (all therapies)
−Removed: 206.8 million
−Removed: Type 2 (insulin only)
+Added: Worldwide Domestic
+Added: Type 1 24.2 million 1.6 million
+Added: Type 2 (all therapies) 206.8 million 25.4 million
+Added: Type 2 (insulin only) 5 million 1.5 million
(1) Internal estimates based on data from the International Diabetes Federation and the Centers for Disease Control and Prevention (CDC)
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There are two primary therapies used by people with insulin-dependent diabetes, insulin injections and insulin pumps.
−Removed: The use of insulin injections is often referred to as Multiple Daily Injection, or MDI, therapy.
+Added: The use of insulin injections is often referred to as Multiple Daily Injection (MDI) therapy.
Insulin pumps are intended to more closely resemble the physiologic function of a healthy pancreas and use rapid-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements.
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Since our initial commercial launch, we have been able to rapidly innovate and bring more products to market than our competitors.
−Removed: We have commercially launched seven insulin pumps since inception, all of which have been developed using our proprietary technology platform.
+Added: We have commercially launched seven insulin pump configurations since inception, all of which have been developed using our proprietary technology platform.
The following table provides information regarding the commercial availability of our insulin pump products:
+Added: Commercial Availability Outside U.S.
Commercial Availability
−Removed: OUS Commercial Availability
−Removed: August 2012 - October 2016
−Removed: May 2015 - June 2018
−Removed: September 2015 - August 2017
−Removed: October 2016 - September 2017
−Removed: t:slim X2 with G5
−Removed: September 2017 - August 2018
−Removed: September 2018 - present
+Added: t:slim August 2012 - October 2016 N/A
+Added: t:flex May 2015 - June 2018 N/A
+Added: t:slim G4 September 2015 - August 2017 N/A
+Added: t:slim X2 October 2016 - September 2017 N/A
+Added: t:slim X2 with G5 September 2017 - August 2018 September 2018 - present
(varies by geography)
−Removed: t:slim X2 with Basal-IQ technology
−Removed: August 2018 - present
−Removed: September 2019 - present
+Added: t:slim X2 with Basal-IQ technology August 2018 - present September 2019 - present
(varies by geography)
−Removed: t:slim X2 with Control-IQ technology
−Removed: January 2020 - present
+Added: t:slim X2 with Control-IQ technology January 2020 - present Scaling launch began July 2020
(to vary by geography)*
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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 percent smaller than other pumps, yet can hold up to 300-units of insulin.
+Added: • 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.
t:slim X2 Profile (Actual Size)
−Removed: Flexible technology - Can be used with or without automated insulin delivery or CGM - 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: We currently offer integration with Dexcom’s G5 or G6 sensor, depending on geography.
−Removed: AID features (availability varies by geography) - We have commercially launched two different AID algorithms on our t:slim X2 platform - Basal-IQ technology and Control-IQ technology.
+Added: • Flexible technology - The device can be used with or without AID or CGM.
+Added: 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.
+Added: • AID features (availability varies by geography) - We have commercially launched two AID algorithms on our t:slim X2 platform:
+Added: Basal-IQ technology and Control-IQ technology.
◦ Basal-IQ technology:
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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.
−Removed: Connectivity - 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 rapid data uploads.
+Added: 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.
+Added: • Connectivity - The t:slim X2 features a two-way Bluetooth wireless technology radio for communicating with more than one external device at a time.
+Added: It also features a micro-USB connection that supports charging the lithium-polymer battery, software updates and optional rapid data uploads.
Tandem Device Updater :
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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: Because remote updatability for insulin pump software is a unique feature not available in competitive pump offerings, the Tandem Device Updater provides our customers with the capability to access new and enhanced features and functionality faster than the industry has been able to in the past.
It was cleared by the FDA in the third quarter of 2016 and launched outside the United States in the third quarter of 2019.
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.
−Removed: Outside the United States we began offering no-cost software updates for Basal-IQ technology in the third quarter of 2019 and intend to begin offering Control-IQ technology updates in select geographies in the second half of 2020, subject to regulatory approvals and other factors.
−Removed: 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 and supported blood glucose meters.
+Added: 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.
+Added: 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.
+Added: 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.
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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: We also plan to launch our new mobile application that when used with Control-IQ technology, is designed to wirelessly upload pump data to t:connect, receive notification of pump alerts and alarms, and provide a discrete, secondary display of glucose and insulin data.
+Added: 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.
+Added: 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.
We believe t:connect can serve as a key component of additional mobile health applications that are currently under development.
−Removed: t:connect and t:connect HCP are currently not available to users or healthcare providers outside the United States.
+Added: During the second quarter of 2020, we acquired Sugarmate, Inc.
+Added: (Sugarmate), the developer of a popular mobile app for people with diabetes who use insulin.
+Added: The Sugarmate app is designed to help people with diabetes visualize diabetes therapy data in innovative ways.
+Added: It allows users to log glucose data and health and nutrition information, and can provide notifications and alerts to users, their family, and their caregivers.
+Added: Sugarmate became a wholly owned subsidiary of Tandem, and is continuing to be led by its founder, who joined our Company.
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 we are uniquely positioned to significantly expand and further penetrate 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: 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.
To achieve our goal, we intend to pursue the following business strategies:
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• expand the value provided by our portfolio through an ecosystem approach to diabetes management;
−Removed: build deeper relationships with all stakeholders across multiple channels, including virtual and tele-health platforms;
+Added: • build deeper relationships with all stakeholders across multiple channels, including virtual and telehealth platforms;
• leverage our manufacturing operations to achieve cost and production efficiencies;
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Products Under Development
−Removed: Our products under development support our strategy of developing insulin delivery systems as part of a therapy management portfolio designed to improve patient outcomes, and include AID system enhancements, a next-generation hardware platform, and connected (mobile) health offerings.
−Removed: t:sport Insulin Delivery System:
−Removed: Our Next-Generation Hardware Platform
−Removed: Our next-generation hardware platform is referred to under its development name, the t:sport Insulin Delivery System, or t:sport.
−Removed: The t:sport pump is half the size of t:slim X2 and 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, and a Bluetooth radio.
+Added: Our products under development support our strategy of focusing on both consumer and clinical needs, which can vary greatly person-to-person.
+Added: 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.
+Added: 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:
+Added: • creating new hardware platform options;
+Added: • continuing AID system evolution;
+Added: • expanding connected (mobile) health offerings;
+Added: • adding and enhancing system components.
+Added: New Hardware Platform Options
+Added: 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.
+Added: 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.
+Added: Our new hardware platforms are being designed to be CGM integrated and compatible with our AID algorithms.
+Added: 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).
+Added: The t:sport pump is half the size of t:slim X2 and is expected to be controlled using our mobile device application.
+Added: It is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump.
+Added: 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.
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: t:sport will utilize a pumping mechanism that differs from our current Micro-Delivery technology used in the t:slim pump platform.
+Added: The t:sport pumping mechanism differs from our current micro-delivery technology used in the t:slim pump platform.
t:sport Shown with Mobile App Controller
−Removed: Based on the FDA’s feedback, we are designing the product so that it will have the technical capability to be controlled using either a dedicated controller or our mobile device application.
−Removed: We expect that each of these functionalities will require separate regulatory reviews by the FDA.
−Removed: We plan to first pursue FDA authorization for t:sport as an ACE pump in 2020 and to thereafter submit for regulatory approvals outside the United States.
−Removed: We are designing t:sport to be compatible with our AID algorithms and any available iCGM.
−Removed: Connected (Mobile) Health Offerings
−Removed: We are preparing for the launch of a mobile application that has been designed to wirelessly upload pump data to our t:connect database management application, receive notification of pump alerts and alarms, and provide a discrete, secondary display of pump therapy data.
−Removed: Future updates of this app are expected to integrate other health-related information from third party sources and, subject to future regulatory approvals, support future pump-control capabilities for t:slim X2 and other products under development.
−Removed: The launch of the first generation of this app in the United States follows the availability of our Control-IQ technology.
−Removed: We also expect the wireless upload of data to the t:connect database will reduce patient burden and increase healthcare provider office efficiency by reducing the manual steps historically required for data extraction.
+Added: AID System Evolution
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Digital Health Offerings
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Future updates of our mobile application are planned to include additional pump control features and integrate other health-related information from third-party sources.
+Added: 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.
+Added: 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.
+Added: The platform is also being designed to enhance the user experience, streamline the pump and supplies purchasing process, and provide internal efficiencies.
+Added: 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.
+Added: We intend to launch the first element of this new platform under the name Tandem Source.
+Added: Tandem Source is our second generation data management application that we intend to first offer outside the United States.
+Added: It is a customizable dashboard designed to deliver the data and insights needed to expertly manage diabetes.
+Added: With Tandem Source, healthcare providers and people living with diabetes have a trusted and reliable destination to review and analyze pump performance over time.
+Added: 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.
+Added: 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.
+Added: Adding and Enhancing System Components
+Added: Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complimentary system components.
+Added: This includes integration with CGM, expansion of insulin administration and infusion set technology, and the use of alternative insulins.
+Added: In November 2020, we entered into an agreement with Dexcom to extend our current collaboration to include integration with their future G7 CGM technology.
+Added: Following integrated product development work, and required regulatory clearances or approvals, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices.
+Added: In June 2020, we announced an agreement with Abbott Laboratories (Abbott) to develop and commercialize integrated diabetes solutions that combine Abbott’s CGM technology with our insulin delivery systems.
+Added: Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S.
+Added: and Canada, with additional geographies considered in the future.
Sales, Marketing and Customer Care
−Removed: In 2019 , we expanded the number of territories in our U.S.
−Removed: sales organization from approximately 70 to approximately 90 by year-end.
+Added: In 2020, our U.S.
+Added: sales organization was comprised of approximately 90 territories.
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.
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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 anticipated in 2020.
−Removed: In Canada, we established a small direct sales and clinical infrastructure, and commenced marketing and sales efforts following Health Canada approval of the t:slim X2 with G5 integration in October 2018.
−Removed: In November 2019, we received Health Canada approval for the t:slim X2 with Basal-IQ technology.
−Removed: Throughout 2019, we also secured reimbursement in the majority of Canadian provinces, and these efforts will continue in 2020.
+Added: However, only modest territory optimizations and expansions are planned in 2021.
+Added: 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.
+Added: 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.
+Added: In December 2020, Health Canada approved the t:slim X2 with Control-IQ technology, which we anticipate commercializing in the first quarter of 2021.
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.
1 unchanged sentence
Unlike our domestic operations, our international distributors (other than in Canada) have substantially greater responsibility for sales, marketing and customer support efforts.
−Removed: Our international distributors in 2019 covered several geographies including:
−Removed: Australia, Italy, New Zealand, Scandinavia (Denmark, Norway and Sweden), South Africa, Spain, and the United Kingdom.
−Removed: In 2020, our international distributors will also cover Germany, France, Belgium, Luxembourg and the Netherlands.
+Added: As of the end of 2020, our international distributors covered nearly 20 countries.
+Added: In 2021, we anticipate our international distributor coverage will expand to approximately 25 countries.
Revenue Concentrations and Significant Customers.
1 unchanged sentence
During the year ended December 31, 2020, we made sales to approximately 43 independent distributors in the United States, and 12 independent distributors internationally.
−Removed: In fiscal 2019 , sales to Byram Healthcare and RGH Enterprises, Inc.
−Removed: accounted for 15.4% and 14.8% of consolidated sales, respectively.
−Removed: In fiscal 2018, sales to RGH Enterprises, Inc.
−Removed: and Byram Healthcare accounted for 19.4% and 15.6% of consolidated sales, respectively.
+Added: During the year ended December 31, 2020, sales to our two largest distributors accounted for 15.9% and 12.9% of consolidated sales, respectively.
+Added: During the year ended December 31, 2019, sales to our two largest distributors accounted for 14.8% and 15.4% of consolidated sales, respectively.
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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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 have transitioned to an alternative pump, and that remaining Animas pump users will likely switch in 2020 as they use up their remaining supplies.
+Added: Accordingly, we believe that the vast majority of Animas pump users transitioned to an alternative pump by the end of 2019.
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.
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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 2020 we expect to expand our customer care infrastructure, including investments in facilities, technology and personnel, to meet the needs of our larger base of in-warranty customers.
+Added: 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.
We also provide training to our distribution partners who fulfill their customer care responsibilities outside the United States.
5 unchanged sentences
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.
−Removed: However, pump eligibility criteria for people with type 2 diabetes can be different and often requires additional documentation and laboratory testing to gain in-network insurance reimbursement benefits.
+Added: However, pump eligibility criteria for people with type 2 diabetes can be different and may require additional documentation and laboratory testing to gain in-network insurance reimbursement benefits.
We enter into contracts with national and regional third-party payors to establish reimbursement for our insulin pump products, disposable 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: For the year ended December 31, 2019 , approximately 27% of our sales in the United States were generated through our direct third-party payor contracts.
+Added: In July 2020, we were named as a network provider by UnitedHealthcare.
+Added: 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: For the year ended December 31, 2020, approximately 30% of our sales in the United States were generated through our direct third-party payor contracts, compared to approximately 27% for the same period of 2019.
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.
As of December 31, 2020, we had executed distributor agreements with approximately 43 independent distributors in the United States.
−Removed: In some 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.
−Removed: However, UnitedHealthcare designated one of our competitors as their preferred, in-network durable medical equipment provider of insulin pumps for most customers over seven years of age.
−Removed: Unless UnitedHealthcare implements a change to its coverage policies for insulin pumps, we expect this decision will prevent a majority of UnitedHealthcare members from purchasing our insulin pump , whether directly from us or through our network of distributors.
+Added: 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.
Our distribution partners outside the United States and Canada are responsible for all reimbursement, tender application and fulfillment activities.
1 unchanged sentence
Historically, we have manufactured our pump and disposable cartridge products at our Barnes Canyon facility in San Diego, California.
−Removed: In 2020, we anticipate 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 for implementation in 2020.
−Removed: We anticipate these investments will allow us to double our cartridge manufacturing capacity from 2019 to 2020, without meaningfully increasing the cost of overhead associated with our manufacturing facilities.
+Added: 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.
+Added: In 2019, we made capital expenditure investments for the expansion of warehousing capacity and ordered additional manufacturing equipment that was implemented in 2020.
+Added: 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.
We believe these investments position us well to achieve our long-term gross margin targets.
We currently utilize a semi-automated manufacturing process for our pump products and disposable cartridges.
−Removed: The pump production line reaches a maximum output of approximately 30,000 pumps per year on a single shift.
−Removed: In 2019, we scaled from two to three pump manufacturing lines and currently have the capacity to produce approximately 180,000 pumps annually.
+Added: 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.
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: In 2019, we had four cartridge manufacturing lines and improved the efficiency of our disposable cartridge manufacturing process, which provided us capacity to build 16 million units annually.
−Removed: We also began investing in three additional cartridge manufacturing lines that will become operational at our third-party manufacturing location.
−Removed: When fully operational, we believe our seven cartridge manufacturing lines can support an installed base of more than 250,000 customers.
+Added: 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.
Outside suppliers are the source for most of the components and some sub-assemblies in the production of our insulin pumps.
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Members of our quality department also inspect our devices at various steps during the manufacturing cycle to facilitate compliance with our devices’ stringent specifications.
−Removed: We have received certification from BSI Group, a Notified Body to the International Standards Organization, or ISO, of our quality system.
+Added: We have received certification from BSI Group, a Notified Body to the International Standards Organization (ISO), of our quality system.
Certain processes utilized in the manufacturing and testing of our devices have been verified and validated as required by the FDA and other regulatory bodies.
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Research and Development
−Removed: Our research and development team includes employees who specialize in software engineering, mechanical engineering, electrical engineering, fluid dynamics, mobile connectivity and graphical user interface design, many of whom have considerable experience in diabetes-related products.
+Added: 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.
Our research and development team focuses on the continuous improvement and support of current product offerings, as well as our products under development.
In June 2015, we entered into non-exclusive agreements with DexCom to allow the integration of our insulin pump products with the DexCom G5 and G6 CGM systems worldwide.
−Removed: Each agreement has 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 agreement.
+Added: 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.
+Added: 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 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.
The agreements do not require any licensing fees, milestone payments or royalty obligations to DexCom.
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Nevertheless, the terms of our agreement with TypeZero remain effective until the patents covered by the agreement have expired, subject to customary provisions for termination in the event of an uncured material breach.
−Removed: In October 2019, we and Abbott Laboratories, or Abbott, announced that we intend to develop and commercialize integrated diabetes solutions that combine Abbott's glucose sensing technology with Tandem's innovative insulin delivery systems to provide additional treatment options for people with insulin-dependence to manage their diabetes.
−Removed: These development and commercialization plans are contingent on the negotiation of a definitive agreement, and while the parties are currently exploring a business relationship, there can be no assurance that an agreement will be reached or that any agreement will be on the terms that are currently being discussed.
+Added: In June 2020 we announced an agreement with Abbott to develop and commercialize integrated diabetes solutions that combine Abbott’s CGM technology with our insulin delivery systems to provide more options for people to manage their diabetes.
+Added: Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S.
+Added: and Canada, and consider additional geographies in the future.
Intellectual Property
13 unchanged sentences
As of December 31, 2020, we had paid the initial license fees in full and have not entered into any sublicense agreements.
+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.
+Added: 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.
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.
−Removed: In late 2017, Eli Lilly & Co.
−Removed: announced that it was developing an insulin pump with AID technology, and there are several other companies that are currently marketing insulin pump products in international markets.
+Added: In addition, Eli Lilly & Co.
+Added: has announced a collaboration to commercialize a version of Ypsomed AG’s existing insulin pump as part of a to-be-developed system.
+Added: 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.
+Added: market, including insulin pumps and Bluetooth-enabled insulin pens to support MDI therapy.
+Added: Additionally, several other companies currently market insulin pump products in international markets.
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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FDA’s Pre-Market Clearance and Approval Requirements.
−Removed: Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a pre-market notification under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA through the Premarket Approval, or PMA, process.
+Added: Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a pre-market notification under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA through the premarket approval (PMA), process.
Both the 510(k) clearance and PMA processes can be expensive, lengthy and require payment of significant user fees, unless an exemption is available.
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Devices requiring fewer controls because they are deemed to pose lower risk are placed in Class I or II.
−Removed: Class I devices are subject to general controls such as labeling, pre-market notification and adherence to the FDA’s Quality System Regulation, or QSR, which cover manufacturers’ methods and documentation of the design, testing, production, control quality assurance, labeling, packaging, sterilization, storage and shipping of products.
+Added: Class I devices are subject to general controls such as labeling, pre-market notification and adherence to the FDA’s Quality System Regulation (QSR), which cover manufacturers’ methods and documentation of the design, testing, production, control quality assurance, labeling, packaging, sterilization, storage and shipping of products.
Class II devices are subject to special controls such as performance standards, post-market surveillance, FDA guidelines, or particularized labeling, as well as general controls.
3 unchanged sentences
A PMA application is required for devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices, or those that are “not substantially equivalent” either to a device previously cleared through the 510(k) process or to a “preamendment” Class III device in commercial distribution before May 28, 1976 when PMA applications were not required.
−Removed: t:slim G4 and t:slim X2 with G5 integration, and t:slim X2 with Basal-IQ technology received FDA approval as Class III devices.
+Added: t:slim G4, t:slim X2 with G5 integration and t:slim X2 with Basal-IQ technology received FDA approval as Class III devices.
There are three new Class II categories classified by the FDA for the interoperability of devices as a complete AID system that are intended to help support continued rapid innovation by streamlining the regulatory pathway for integrated products approved by the FDA.
−Removed: In June 2018, our t:slim X2 with Basal-IQ technology was the first insulin pump to receive approval for iCGM compatibility.
−Removed: In February 2019, we received FDA approval of our De Novo application to classify the t:slim X2 to a Class II device, under the new insulin pump classification referred to as ACE pumps.
−Removed: Most recently, in December 2019 we received FDA approval of our De Novo application to classify our Control-IQ technology as the first automated insulin dosing software in a new interoperable automated glycemic controller category that automatically adjusts insulin delivery to a person with diabetes by connecting to an ACE pump and iCGM.
−Removed: In connection with the De Novo applications for both the ACE pump and the interoperable automated glycemic controller category the FDA also established certain special controls that we will need to continue to satisfy.
+Added: In June 2018, our t:slim X2 was the first insulin pump designated by the FDA as compatible with integrated continuous glucose monitoring (iCGM) devices.
+Added: In February 2019, we received FDA approval of our de novo application to classify the t:slim X2 to a Class II device, under the new insulin pump classification referred to as Alternate Controller Enabled Infusion Pumps (ACE pumps).
+Added: In December 2019, we received FDA approval of our de novo application to classify our Control-IQ technology as the first automated insulin dosing software in a new interoperable automated glycemic controller (iAGC) category that automatically adjusts insulin delivery to a person with diabetes by connecting to an ACE pump and iCGM.
+Added: In connection with the de novo applications for both the ACE pump and the iAGC category, the FDA established certain special controls that we will need to continue to satisfy.
+Added: In March 2020, our Basal-IQ technology was also cleared as an iAGC.
If we are not able to satisfy those special controls, we would be required to seek approval for those products under the traditional PMA submission process.
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The FDA can delay, limit or deny approval of a PMA application for many reasons, including:
−Removed: systems may not be safe or effective to the FDA’s satisfaction;
−Removed: the data from pre-clinical studies and clinical trials may be insufficient to support approval;
+Added: • systems may not be deemed safe or effective to the FDA’s satisfaction;
+Added: • the data from pre-clinical studies and clinical trials may be deemed insufficient to support approval;
• the manufacturing process or facilities may not meet applicable requirements;
8 unchanged sentences
Clinical trials are typically required to support a PMA application and are sometimes required for a 510(k) clearance.
−Removed: These trials generally require submission of an application for an Investigational Device Exemption, or IDE, to the FDA.
+Added: These trials generally require submission of an application for an Investigational Device Exemption (IDE), to the FDA.
The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.
6 unchanged sentences
The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product.
−Removed: The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited to, the following:
+Added: The commencement or completion of any clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application or a 510(k) notification, for numerous reasons, including, but not limited to, the following:
• the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;
6 unchanged sentences
• third-party clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol, good clinical practices or other FDA requirements;
−Removed: we or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans;
−Removed: third-party clinical investigators have significant financial interests related to us or our study that the FDA deems to make the study results unreliable, or the company or investigators fail to disclose such interests;
+Added: • we or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or in a manner consistent with the clinical trial protocol or investigational or statistical plans;
+Added: • third-party clinical investigators have significant financial interests related to us or our study that the FDA deems the study results unreliable, or the company or investigators fail to disclose such interests;
• regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials;
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• labeling regulations that prohibit the promotion of products for uncleared, unapproved or “off-label” uses, and impose other restrictions on labeling, advertising and promotion;
−Removed: the FDA’s Medical Device Reporting, or MDR regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;
+Added: • the FDA’s Medical Device Reporting (MDR) regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;
• voluntary and mandatory device recalls to address problems when a device is defective and could be a risk to health;
1 unchanged sentence
Also, the FDA may require us to conduct post-market surveillance studies or establish and maintain a system for tracking our products through the chain of distribution to the patient level.
−Removed: We are currently in the planning phases for a post-market surveillance study for our t:slim X2 with Control-IQ technology.
+Added: We are currently conducting a post-market surveillance study for our t:slim X2 with Control-IQ technology for users with type 1 diabetes age six and above.
+Added: We may elect to pursue additional post-market surveillance studies in the future.
The FDA and the Food and Drug Branch of the California Department of Health Services enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.
11 unchanged sentences
• operating restrictions;
+Added: • injunctions;
• criminal prosecution.
−Removed: We and our contract manufacturers, specification developers and some suppliers of components or device accessories, are required to manufacture our products in compliance with current Good Manufacturing Practice, or GMP, requirements set forth in the QSR.
+Added: We and our contract manufacturers, specification developers and some suppliers of components or device accessories, are required to manufacture our products in compliance with current Good Manufacturing Practice, (GMP), requirements set forth in the QSR.
The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and it includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.
1 unchanged sentence
If the FDA believes that we or any of our contract manufacturers, or regulated suppliers, are not in compliance with these requirements, it can shut down our manufacturing operations, require recall of our products, refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.
−Removed: In the United States, several states require that durable medical equipment, or DME, providers be licensed in order to sell products to patients in that state.
+Added: In the United States, several states require that durable medical equipment (DME), providers be licensed in order to sell products to patients in that state.
Some of these states require that DME providers maintain an in-state location or retain a licensed pharmacist, and in those states, we sell our products through a third-party distributor.
5 unchanged sentences
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, or 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 Acts, 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.
29 unchanged sentences
t:connect data is hosted on secure servers and our use of t:connect data is subject to internal policies and procedures that are designed to comply with the federal U.S.
−Removed: Health Insurance Portability and Accountability Act of 1996, or HIPAA, as well as applicable U.S state privacy laws (including, but not limited to, the California Consumer Privacy Act).
−Removed: Although t:connect and t:connect HCP are not currently available to users or healthcare providers outside the United States, we are also mindful of requirements under Canada’s Personal Information Protection and Electronic Documents Act, referred to as PIPEDA, and similar provincial laws, and the E.U.
+Added: Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as applicable U.S state privacy laws (including, but not limited to, the California Consumer Privacy Act).
+Added: Although t:connect and t:connect HCP are not currently generally available to users or healthcare providers outside the United States, we are also mindful of requirements under Canada’s Personal Information Protection and Electronic Documents Act, referred to as PIPEDA, and similar provincial laws, and the E.U.
General Data Protection Regulation, commonly known as GDPR, and similar E.U.
14 unchanged sentences
Failure to submit the required data in an accurate and timely manner may result in the imposition of civil monetary penalties.
−Removed: We believe we are in substantial compliance with the Physician Payments Sunshine Act.
+Added: We believe we are in substantial compliance with the Physician Payments Sunshine Act to date.
+Added: 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.
Anti-Bribery and Anti-Corruption Laws.
−Removed: Foreign Corrupt Practices Act, or the FCPA, and similar laws in foreign jurisdictions generally prohibit U.S.
+Added: Foreign Corrupt Practices Act (FCPA), and similar laws in foreign jurisdictions generally prohibit U.S.
corporations and their representatives from offering, promising, authorizing or making improper payments, gifts or transfers to any foreign government official in order to obtain or retain business.
5 unchanged sentences
There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.
−Removed: The primary regulatory body in Europe is that of the European Union, which includes most of the major countries in Europe.
+Added: The primary regulatory body in Europe is the European Union, which includes most of the major countries in Europe.
Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices.
The European Union has adopted numerous directives and standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices.
−Removed: Devices that comply with the requirements of a relevant directive will be entitled to bear the CE conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be commercially distributed throughout Europe.
+Added: These directives are in the process of being replaced by the Medical Device Regulation.
+Added: Devices that comply with the requirements of a relevant directive or regulation will be entitled to bear the CE conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be commercially distributed throughout Europe.
The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body.” This third-party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s product.
2 unchanged sentences
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: As of December 31, 2019, we had 1,043 full-time employees.
+Added: 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: 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.
+Added: Registrations can only be submitted by UK manufacturers or by a UK Responsible Person who has a place of business in the UK.
+Added: A UK Responsible Person is a person who acts on behalf of a manufacturer established outside the UK in relation to specified tasks with regard to the manufacturer’s obligations.
+Added: Information Security
+Added: 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.
+Added: We regularly review and modify our information security program to reflect changes in technology, laws, regulations, risks, industry practices, and other business needs.
+Added: On an annual basis, we receive external audits of our information security posture, after which we remediate any findings.
+Added: We hold cybersecurity insurance to mitigate against losses from a range of potential cyber incidents.
+Added: Our management briefs our board of directors or a committee thereof on information security on a quarterly basis.
+Added: Environmental Impact and Sustainability
+Added: 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.
+Added: 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: 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.
+Added: In addition, we have dedicated efforts toward the reduction of energy use in our lighting.
+Added: We have actively pursued rebates from San Diego Gas & Electric to fund energy improvement projects, and our facilities use LED lighting, motion sensors, or both, to reduce energy consumption.
+Added: We are also working to reduce energy consumption for air conditioning and heating through occupancy scheduling.
+Added: Our manufacturing processes are not water intensive, and we use hands-free automatic sink faucets and automatic toilet flush valves in all buildings.
+Added: We are also working to reduce landfill waste by baling and recycling our cardboard, and we have a commingled recycling program in place.
+Added: 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.
+Added: We estimate that our customers have kept approximately 8.7 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 18.4 million batteries.
+Added: 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.
+Added: 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.
+Added: In addition, we have reduced the size of our cartridge pouch so that it uses less packaging material.
+Added: We continue to use innovative techniques to reduce environmental impact and deliver products that can change people’s lives.
+Added: Community Outreach and Impact
+Added: We strive to be a good corporate citizen in the communities in which our employees live and work.
+Added: Our employee community outreach efforts include donations and volunteer work, serving on boards and advisory committees and other corporate and individual actions.
+Added: In 2020, we extended our employee giving campaigns to include support for PRIDE organizations in San Diego and Boise.
+Added: 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.
+Added: 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.
+Added: In 2020, we joined JDRF as a national partner, supporting their events nationally at a higher level than ever before.
+Added: For many people with diabetes, peer support plays a key role in successful diabetes management.
+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 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: Human Capital
+Added: As of December 31, 2020, we had approximately 1,500 regular full-time employees, all of whom work in the United States or Canada.
+Added: The term “employees” in this Annual Report means our regular full-time employees.
+Added: 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.
+Added: In addition, we maintain an office in Boise, Idaho, where employees focus primarily on customer care, 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.
We believe we have good relations with our employees.
−Removed: Executive Officers
−Removed: Blickenstaff (age 67) has served as Executive Chairman of our board of directors since March 2019, and previously served as President and Chief Executive Officer from September 2007 to March 2019.
−Removed: Blickenstaff has served as one of our directors since September 2007.
−Removed: We recently announced that Mr.
−Removed: Blickenstaff will transition to the role of Chairman of our board of directors in March 2020.
−Removed: Prior to joining our company, he served as Chairman and Chief Executive Officer of Biosite Incorporated, or Biosite, a provider of medical diagnostic products, from 1988 until its acquisition by Inverness Medical Innovations, Inc.
−Removed: in June 2007.
−Removed: Blickenstaff previously served as a director of Medivation, Inc.
−Removed: MDVN), a biotechnology company, from 2005 to 2016, until its acquisition by Pfizer, and as a director of DexCom, Inc.
−Removed: DXCM), a provider of CGM systems, from June 2001 to September 2007.
−Removed: Blickenstaff was formerly a certified public accountant and has more than 20 years of experience overseeing the preparation of financial statements.
−Removed: He received a B.A.
−Removed: in Political Science from Loyola University, Chicago, and an M.B.A.
−Removed: from the Graduate School of Business, Loyola University, Chicago.
+Added: Fostering and maintaining a strong, healthy culture is a key strategic focus.
+Added: 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”.
+Added: 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.
+Added: Our core values statement was created by our employees in a bottom-up, cross-functional process.
+Added: These core values reflect who we are and the way our employees interact with one another, our customers, partners and stockholders.
+Added: 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: No shortcuts is holding ourselves to the highest ethical standards and delivering exceptional quality.
+Added: Huddle up highlights the importance of successful collaboration that is inclusive of diverse perspectives, both inside and outside of the Company.
+Added: 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.
+Added: 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: 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: We have detailed ethics and compliance policies that instill a commitment to ethical behavior and legal compliance across our company.
+Added: Employees are encouraged to approach their managers if they believe violations of standards or policies have occurred.
+Added: Employees are also able to make confidential and anonymous reports using an online or telephone hotline hosted by a third party provider.
+Added: Diversity and Inclusion
+Added: 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.
+Added: More than half of our employees are female, includin g one-third of o ur employees at the Vice President level or higher, and approximately half of our employees are from an underrepresented ethnic community.
+Added: We believe that bringing together different perspectives and experiences is fundamental to innovation and continue raising the bar in the field of diabetes technology.
+Added: 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.
+Added: 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: Organizational Development
+Added: Attracting, developing and retaining employees is critical to our longer term success.
+Added: 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: We leverage both formal and informal programs to identify, foster, and retain top talent at both the corporate and operating level.
+Added: We have established a comprehensive training program to develop employees throughout the organization.
+Added: Emerging Leaders and Leading in Tandem are examples of internal programs intended for high performing individual contributors, and newly hired and promoted supervisors and managers, respectively.
+Added: 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: Our leadership team also mentors rising talent on a more informal basis.
+Added: This informal mentorship achieves a number of goals, including accelerating the development of top performers, increasing organizational learning, and improving employee performance and retention.
+Added: The executive team also commits substantial time to evaluating the bench strength of our leadership and working with our leadership to improve their performance.
+Added: Total Rewards
+Added: We have demonstrated a history of investing in our workforce by offering competitive salaries and wages.
+Added: Annual increases and incentive compensation are based on merit, which is communicated to employees at the time of hiring and documented through our talent management process as part of our annual review procedures and upon internal transfer and/or promotion.
+Added: To foster a stronger sense of ownership and align the interests of partners with stockholders, stock options and/or restricted stock units are provided to a substantial proportion of our employees under our broad-based stock incentive programs.
+Added: Also, our employees are able to participate in our employee stock purchase program.
+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 and life, disability/accident coverage and a wellness program.
+Added: 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: Employee Health and Safety
+Added: The health and safety of our employees is our highest priority, and this is consistent with our operating philosophy.
+Added: We have integrated our employee health and safety efforts with our human resources functions to create a corporate culture with a shared commitment to the well-being of our professionals.
+Added: Our employee assistance and wellness programs offer a range of benefits and services.
+Added: For example, as a benefit to our employees and their eligible dependents, we provide access to personal and job-related counseling and assistance resources for addressing concerns such as emotional well-being, family and relationships, legal and financial matters, healthy lifestyles, mental health, substance abuse, and work and life transitions.
+Added: Every work day we provide a virtual wellness session featuring guided meditation, stretching, yoga, or exercise.
+Added: Our focused wellness education sessions, generally offered several times per month, cover topics such as parenting, mental health, nutrition, stress management, sleep habits, resilience, and working in a remote environment.
+Added: 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.
+Added: 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: We operate in modern, efficient, and safe facilities, and have had minimal accident and injury rates company-wide.
+Added: Despite this success, however, our goal remains the same:
+Added: zero accidents.
+Added: In the COVID-19 global pandemic, we have been deemed an essential healthcare business under applicable governmental orders based on the critical nature of the products we offer and the communities we serve.
+Added: As a result, our manufacturing and warehousing sites continued operating during the COVID-19 pandemic.
+Added: As such, we have invested in creating physically safe work environments for our employees.
+Added: Our response to the COVID-19 pandemic also included employee safety measures such as:
+Added: • Adding work from home flexibility;
+Added: • Increasing cleaning protocols across all locations;
+Added: • Initiating regular communication regarding impacts of the COVID-19 pandemic, including health and safety protocols and procedures;
+Added: • Implementing temperature screening of employees at the majority of our manufacturing and warehousing facilities;
+Added: • Establishing new physical distancing procedures for employees who need to be onsite;
+Added: • Providing additional personal protective equipment and cleaning supplies;
+Added: • Implementing protocols to address actual and suspected COVID-19 cases and potential exposure;
+Added: • Limiting domestic and international non-essential travel for all employees;
+Added: • Requiring masks to be worn in all locations where mandated by local law.
+Added: COVID-19 Global Pandemic Impact and Considerations
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: To that end, we have increased the frequency of our communications to employees, suppliers, customers, and healthcare providers.
+Added: 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.
+Added: 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.
+Added: We continue to work closely with our healthcare providers and customers, remaining flexible in our method of interaction.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: For example, in the first quarter of 2020, we observed customers purchasing cartridges and infusion sets at a higher rate than anticipated.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Sheridan (age 65) has served as our President and Chief Executive Officer since March 2019 and as a member of our board of directors since June 2019.
9 unchanged sentences
from Boston University.
−Removed: Berger (age 50) has served as our Chief Legal and Compliance Officer since April 2019, as General Counsel since August 2013, as our Corporate Secretary since January 2015, and as our Executive Vice President since January 2016.
+Added: 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.
+Added: 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.
From January 2008 until August 2013, Mr.
2 unchanged sentences
From April 2003 until October 2007, Mr.
−Removed: Berger was responsible for all commercial aspects of legal affairs at Biosite, most recently serving as Vice President, Legal Affairs.
+Added: Berger was responsible for all commercial aspects of legal affairs at Biosite Incorporated (Biosite), a provider of medical diagnostic products, most recently serving as Vice President, Legal Affairs.
Previously, Mr.
12 unchanged sentences
from the School of Business at San Diego State University.
−Removed: Gasser (age 44) has served as our Executive Vice President of Strategy and Corporate Development since January 2020.
+Added: Gasser (age 45) has served as our Executive Vice President, Strategy and Corporate Development since January 2020.
Prior to joining our company, Ms.
6 unchanged sentences
in Economics from the University of Cambridge.
−Removed: Morrison (age 40) has served as our Chief Administrative Officer since September 2013 and as an Executive Vice President since December 2017.
+Added: 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.
From April 2013 until September 2013, she served as our Vice President, Human Resources, Corporate and Investor Relations.
21 unchanged sentences
Additional Information
−Removed: We were incorporated in Colorado in January 2006 and reincorporated in Delaware in January 2008.
Our website address is www.tandemdiabetes.com .
We post links to our website to the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the SEC:
−Removed: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act.
+Added: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act).
All such filings are available through our website free of charge.
1 unchanged sentence
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.