−Removed: References within this Annual Report to “Tandem,” “we,” “our,” “us,” “management,” or the “Company” refer to Tandem Diabetes Care, Inc., together with its wholly-owned subsidiaries in the United States, Canada and the Netherlands.
−Removed: We are a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes.
+Added: References within this Annual Report to “Tandem,” “we,” “our,” “us,” “management,” or the “Company” refer to Tandem Diabetes Care, Inc., together with its wholly-owned subsidiaries in the United States, Canada, the Netherlands, and Switzerland.
+Added: Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers.
+Added: Our pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology.
+Added: We are based in San Diego, California.
+Added: We consider our primary addressable market to be people who live with type 1 diabetes.
+Added: Through our product development efforts, we are seeking to expand our addressable market to include people living with type 2 diabetes who require intensive insulin therapy.
Diabetes management can vary greatly from person to person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: Our goal is to lead in insulin therapy management across multiple of these market segments by providing a robust ecosystem and portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
−Removed: Since our initial commercial launch, we have rapidly innovated and brought more products to market than our competitors.
−Removed: Today, the t:slim X2 Insulin Delivery System (t:slim X2) is our flagship technology solution.
−Removed: In the four-year period ended December 31, 2022, we shipped approximately 420,000 t:slim X2 insulin pumps, which is representative of our estimated global installed customer base, assuming the typical four-year reimbursement cycle.
−Removed: Approximately 290,000 of these pumps were shipped to customers in the United States and 130,000 were shipped to customers outside the United States.
−Removed: Our products are currently available in approximately 25 countries outside the United States.
−Removed: Our manufacturing, sales and support activities principally focus on our flagship pump platform, the t:slim X2 and our complementary product offerings.
−Removed: Our simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available in the United States.
−Removed: The majority of our customers use the t:slim X2 with continuous glucose monitoring (CGM) integration.
−Removed: This allows the t:slim X2 to receive CGM sensor readings, which can then be used in our automated insulin dosing (AID) algorithms, including our Control-IQ technology.
−Removed: Control-IQ is an advanced hybrid-closed loop feature designed to help increase a user's time in their targeted glycemic range.
−Removed: Multiple studies have demonstrated that use of Control-IQ technology provides people across all demographics with improved clinical outcomes that are both immediate and sustained.
−Removed: It was the first system cleared by the U.S.
−Removed: Food and Drug Administration (FDA) to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.
−Removed: The t:slim X2 is unique in that it is the only pump on which remote software updates have been made commercially available in the United States.
−Removed: Now available in the countries we serve worldwide, our Tandem Device Updater (TDU) that has allowed approximately 200,000 people to update their t:slim X2 software from a personal computer.
−Removed: This offering is a competitive advantage that allows us to bring our customers clinical and lifestyle enhancements, such as new developments in our AID technology, CGM integrations and mobile app features.
−Removed: In July 2022, we launched a new pump software update through TDU to allow all t:slim X2 pump users in the United States to bolus insulin using our smartphone app that is available on compatible iOS and Android devices.
−Removed: 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 United States, we also offer t:connect, our data management web application that provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
−Removed: We are focused on developing diabetes solutions that expand our portfolio of insulin pump offerings, provide even greater personalization to our AID algorithms, expand our AID indications, and that further improve the user experience with our diabetes management systems, data product offerings and services we provide.
+Added: Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team flexibility and choice in intelligent insulin delivery systems through an accessible portfolio of market-leading pumps, applications, and insights.
+Added: The t:slim X2 Insulin Delivery System has been our flagship technology solution.
+Added: In February 2024, we expanded our pump portfolio with the U.S.
+Added: launch of Tandem Mobi.
+Added: Both pumps feature our Control-IQ advanced hybrid closed loop technology, with an automated insulin delivery (AID) feature designed to help increase a user's time in targeted glycemic range.
+Added: Our t:slim X2 and Tandem Mobi pumps can be used with a variety of infusion sets to offer patients choice in how and where their pump is worn.
+Added: In addition, they are software updatable from a personal computer and compatible with our web-based data management application.
+Added: In the four-year period ended December 31, 2023, we shipped approximately 450,000 insulin pumps, which is representative of our in-warranty global installed customer base assuming the typical four-year reimbursement cycle.
+Added: Approximately 310,000 pumps were shipped to customers in the United States and 140,000 were shipped to customers outside the United States.
Diabetes and the Insulin Therapy Management Market
Diabetes is a chronic, life-threatening disease for which there is no known cure.
−Removed: Diabetes is typically classified as either type 1 or type 2:
+Added: It is typically classified as either /type 1 or type 2:
• Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin.
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Individuals with type 1 diabetes require intensive insulin therapy to survive.
−Removed: • Type 2 diabetes represents 90% to 95% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly use insulin or produce enough insulin.
+Added: • Type 2 diabetes is characterized by the body’s inability to either properly use insulin or produce enough insulin.
It’s a progressive condition, and a person in the advanced stages of living with type 2 diabetes often requires intensive insulin therapy.
+Added: The Center for Disease Control and Prevention estimates Type 2 accounts for 90-95% of diagnosed diabetes in adults in the United States.
We consider our addressable market to be people diagnosed with diabetes who are living with either type 1 diabetes, or with type 2 diabetes who require intensive insulin therapy.
Throughout this Annual Report, we refer to these individuals as people with insulin-dependent diabetes.
−Removed: Estimated Diagnosed Diabetes Prevalence (1)
−Removed: Worldwide United States
−Removed: Type 1 30.9 million 1.8 million
−Removed: Type 2 (all therapies) 267.3 million 26.9 million
−Removed: Type 2 (insulin-dependent) 10 million 2 million
−Removed: (1) Internal estimates based on data from the International Diabetes Federation and the Centers for Disease Control and Prevention (CDC)
−Removed: Diabetes Management
+Added: In the geographies we serve, we estimate about 5 million people live with type 1 diabetes of whom, 1.9 million reside in the United States.
+Added: We estimate approximately 2 million people in the United States live with type 2 diabetes and require intensive insulin therapy.
Diabetes can be difficult for patients to manage.
3 unchanged sentences
Insulin pumps are intended to more closely resemble the physiologic function of a healthy pancreas and use rapid-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements.
−Removed: Insulin pump systems are most commonly comprised of a programmable, durable device, a disposable cartridge filled with insulin by the user, and a disposable infusion set to administer insulin into the person’s body.
+Added: Insulin pump systems are most commonly comprised of a programmable, durable device, a single-use cartridge filled with insulin by the user, and a single-use infusion set to administer insulin into the person’s body.
This system is typically known as a durable pump and the device itself is expected to last for multiple years.
2 unchanged sentences
More than 1.3 million people worldwide are estimated to use an insulin pump to manage their diabetes.
−Removed: We estimate that 750,000 people in the United States use an insulin pump.
+Added: We estimate that approximately 800,000 people in the United States use an insulin pump, of whom approximately 90% live with type 1 diabetes.
In addition, we estimate that approximately 500,000 people use an insulin pump in approximately 25 countries outside the United States in which our insulin pump is available.
−Removed: Insulin pump therapy can provide benefit to a person with insulin-dependent diabetes when used independently or in conjunction with CGM, which is a therapy that provides users with real-time access to their glucose levels as well as trend information.
+Added: Insulin pump therapy can provide benefit to a person with insulin-dependent diabetes when used independently or in conjunction with continuous glucose monitoring (CGM), which is a technology that provides users with real-time access to their glucose levels as well as trend information.
In addition, insulin pumps may feature an AID algorithm that is designed to automatically adjust a person’s insulin delivery based on their CGM trends and other factors to help minimize the frequency and/or duration of hyperglycemic and/or hypoglycemic events.
−Removed: Insulin pumps may also feature connectivity with mobile apps and data management applications, which are used by the pump user, their caregivers and their healthcare providers, to quickly and easily identify meaningful insights and trends, allowing them to refine therapy and lifestyle choices for better management of their diabetes.
+Added: The American Diabetes Association Standards of Care state that diabetes devices should be offered to people with diabetes.
+Added: It also states that AID systems are preferred over non-automated pumps and MDI, and should be offered for diabetes management to youth and adults with type 1 diabetes.
Our Technology:
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We initially rely on the use of behavioral sciences, including extensive research to ascertain what people with insulin-dependent diabetes require and prefer from their diabetes therapy.
−Removed: We then look to modern consumer technology for inspiration and design our hardware and software solutions to meet the specific demands of people living with diabetes.
+Added: We then look to modern consumer technology for inspiration and design our hardware and software solutions to try to meet the specific demands of people living with diabetes.
This multi-step approach has resulted in products that provide users with the distinct features and functionality they seek and in a manner that makes the features usable and intuitive.
−Removed: Since our initial commercial launch, we have been able to rapidly innovate and bring more products to market than our competitors.
−Removed: The following table provides information regarding the commercial availability of our insulin pump products:
−Removed: Commercial Availability Outside U.S.
−Removed: Commercial Availability
−Removed: t:slim August 2012 - October 2016 N/A
−Removed: t:flex May 2015 - June 2018 N/A
−Removed: t:slim G4 September 2015 - August 2017 N/A
−Removed: t:slim X2 October 2016 - September 2017 N/A
−Removed: t:slim X2 with G5 September 2017 - August 2018 September 2018 - May 2021
−Removed: t:slim X2 with Basal-IQ technology August 2018 - present September 2019* - present
−Removed: t:slim X2 with Control-IQ technology January 2020 - present July 2020* - present
−Removed: *Scaled launch based on the timing of regulatory approvals and other factors.
−Removed: Today, our commercial efforts exclusively focus on the manufacturing, sale and support of our flagship pump platform, the t:slim X2 insulin delivery system.
−Removed: The t:slim X2 insulin delivery system is comprised of a t:slim X2 pump, its 300-unit disposable insulin cartridge and an infusion set.
−Removed: Our t:slim X2 Insulin Pump Form Factor
−Removed: t:slim X2 Insulin Pump
−Removed: Our t:slim X2 was designed to offer greater ease of use and look more like other modern consumer technology, such as a smart phone, as compared to other traditional insulin pumps.
−Removed: Key features include:
−Removed: • Color touchscreen - The large color touchscreen is easy to read, simple to learn, and intuitive to use for anyone familiar with a smartphone or tablet.
−Removed: • Small and discreet - The t:slim X2 pump is up to 38% smaller than other durable pumps, yet the device can hold up to 300-units of insulin.
−Removed: t:slim X2 Profile (Actual Size)
−Removed: • Control-IQ advanced hybrid-closed loop technology:
+Added: Our insulin pumps are generally considered durable medical equipment and have an expected lifespan of at least four years.
+Added: In addition to insulin pumps, we sell single-use products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.
+Added: We launched our flagship t:slim platform in August 2012, and its next generation, the t:slim X2, in October 2016.
+Added: In February 2024, we expanded our offerings with the commercial availability of Tandem Mobi in the United States.
+Added: Both pumps are fully detachable, offer Bluetooth connectivity and can be used as part of an automated insulin delivery system.
+Added: Control-IQ Technology
+Added: Remote Software Updates
+Added: Smartphone Control
+Added: Insulin Capacity
+Added: Integrated Color Touchscreen
+Added: Pump Button for Bolus Delivery
+Added: Our t:slim X2 and Tandem Mobi pumps feature our Control-IQ advanced hybrid closed loop technology.
This AID feature is designed to help increase a user's time in targeted glycemic range (70-180 mg/dL), and is used by the majority of our customers worldwide.
1 unchanged sentence
Control-IQ technology offers optional settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.
−Removed: Results from two independent pivotal studies using Control-IQ technology were published in the New England Journal of Medicine in October 2019 and August 2020.
−Removed: • Connectivity - The t:slim X2 includes a Bluetooth radio for communicating with multiple external devices simultaneously and allows for uploading pump and CGM therapy data to the Tandem cloud via the t:connect mobile app.
−Removed: The t:slim X2 also includes a micro-USB port that supports charging the lithium-polymer battery, software updates and therapy data uploads.
−Removed: • Mobile Control - In the first quarter of 2022, we received FDA clearance for our mobile bolus feature that allows t:slim X2 users to control a bolus of insulin through our t:connect mobile app using their personal smartphone.
−Removed: It is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems.
−Removed: Our mobile app provides users with convenient and discreet data display and alerts, and functions as a pipeline for getting pump data to the cloud.
+Added: Results from three independent pivotal studies using Control-IQ technology were published in the New England Journal of Medicine in October 2019, August 2020 and March 2023.
+Added: As part of our AID systems, we offer pump integration with multiple CGM sensors, which helps provide customizable solutions for people living with diabetes.
+Added: The Dexcom G7 sensor is the fourth generation of Dexcom’s CGM that we have integrated with our pump technology since 2015.
+Added: We began offering our t:slim X2 pump integrated with the Dexcom G7 sensor in the United States in December 2023 and outside the United States in January 2024.
+Added: In addition, in January 2024 we announced that our t:slim X2 insulin pump with Control-IQ technology is the first AID system to integrate with the Abbott FreeStyle Libre 2 Plus sensor.
+Added: Our extensive experience in CGM integration, and efforts to continue expanding the available CGM sensors integrated with our pump portfolio, represents our commitment to provide customizable solutions to help reduce burden and create new possibilities for people living with diabetes.
Tandem Device Updater
−Removed: This tool allows pump users to update their pump software quickly and easily from a personal computer.
−Removed: It is PC- and Mac- compatible and designed to work with the t:slim X2 in a manner similar to software updates on a smartphone.
−Removed: We have used this technology to offer t:slim X2 customers in the United States multiple different software updates for no-cost.
−Removed: Outside the United States we began offering no-cost software updates for Basal-IQ technology in the third quarter of 2019 and Control-IQ technology updates in the third quarter of 2020.
−Removed: Our web-based data management application provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
−Removed: It also provides us with valuable data that we can analyze computationally to reveal patterns, trends and associations that can be used in continuous product improvements and in the analysis of clinical outcomes data.
−Removed: In the third quarter of 2020, we launched the t:connect mobile application that features the wireless upload of pump data to t:connect, allows the user to receive notification of pump alerts and alarms, and provide a discrete, secondary display of glucose and insulin data.
−Removed: The t:connect mobile application is compatible with multiple versions of iOS and Android operating systems, and as of the end of 2022, there were approximately 300,000 downloads of our t:connect mobile app.
−Removed: We believe t:connect (web data management and mobile app) can serve as key components of additional health applications and services that are currently under development.
−Removed: Sugarmate is a popular mobile app that is designed to help people visualize diabetes therapy data in innovative ways.
+Added: This tool allows our pump users to update their pump software quickly and easily from a personal computer.
+Added: It is PC- and Mac- compatible and designed to work with our pumps in a manner similar to software updates on a smartphone.
+Added: We have used this technology to offer our in-warranty t:slim X2 customers worldwide software updates at no cost.
+Added: Tandem Source
+Added: Our web-based data management platform 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: It also provides us with data that we can analyze to reveal patterns, trends, outcomes and associations that can be used to improve our products and in the analysis of clinical outcomes data.
+Added: Tandem Source is designed to bring together the features of Tandem’s legacy t:connect, t:connect HCP, and t:connect Portal offerings with new comprehensive data reporting in one central, scalable platform.
+Added: It offers automatic data transfers from pumps using the t:connect mobile app to keep online data current and remove the need for manual pump uploads.
+Added: Sugarmate is a mobile app that is designed to help people visualize diabetes therapy data in innovative ways.
It allows users to log glucose data and health and nutrition information, and can provide notifications and alerts to users, their family, and their caregivers.
−Removed: Our Strategy & Products Under Development
+Added: Our Strategy & Future Technologies
Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.
−Removed: Our goal is to lead in insulin therapy management across multiple market segments by providing a portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers.
−Removed: We believe our positively different approach to diabetes management uniquely positions us to significantly expand and further penetrate the varying segments of the intensive insulin using diabetes market by focusing on the needs of our customers and their caregivers, and by supporting healthcare providers and payors with real world insights.
−Removed: In support of this strategy, our product development efforts fall into three pillars of innovation:
−Removed: delivery devices, device software including algorithms, and data and insights.
−Removed: Delivery Devices
−Removed: We are developing a family of delivery device solutions to meet the varying needs of people living with type 1 and type 2 diabetes by providing choice within our own portfolio.
−Removed: Preferences in the size, shape, and mode of operation that comprise an insulin pump’s hardware often impact a person’s pump purchasing decision and overall user experience.
−Removed: The Tandem Mobi is approximately half the size of our t:slim X2 pump, and is designed for people who seek even greater discretion and flexibility with the use of their insulin pump.
−Removed: Its features include full pump-control from our mobile application, a 200-unit cartridge, an on-pump bolus button, inductive charging, and an AID algorithm.
−Removed: Advancing our flagship t:slim platform, the t:slim X3 is being designed to provide a modernized user interface and even greater usability for our planned feature updates.
−Removed: It is also being designed to include enhanced technology, such as greater processing power and capacity to support our advanced algorithms, as well as increased battery life, improved durability, and wireless software update capabilities.
−Removed: This offering is being developed to provide an alternative tubeless infusion site option for Mobi pump users.
−Removed: It will allow a Mobi pump to be worn completely on the user’s body with no tubing.
+Added: Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team flexibility and choice in intelligent insulin delivery systems, through an accessible portfolio of market-leading pumps, applications, and insights.
+Added: In support of this strategy, our portfolio of future technologies includes:
+Added: Advancing our flagship t:slim platform, the t:slim X3 is planned to include enhanced technology, such as greater processing power and capacity to support our advanced algorithms, as well as increased battery life and improved durability.
+Added: This offering is intended to provide an alternative tubeless infusion site option for Tandem Mobi pump users.
+Added: It will allow a Tandem Mobi pump to be worn completely on the user’s body with no tubing.
A goal of this design is to allow people living with diabetes to customize the way they wear their pump with each cartridge change, switching between tubed and tubeless wear configurations, to best suit their personal preferences and lifestyle.
−Removed: This ergonomic, rechargeable patch pump is being designed to reduce the burden of managing diabetes through its use of pre-filled insulin cartridges and compatibility with AID technology.
−Removed: This replaces our early-stage development of a disposable tubeless solution that was previously under development.
+Added: The ergonomic, rechargeable Sigi Patch Pump is intended to reduce the burden of managing diabetes through its use of pre-filled insulin cartridges and compatibility with AID technology.
Extended Wear Infusion Sets
1 unchanged sentence
Our goals for infusion set innovations focus on solutions that extend wear time and enhance user experience, while reducing occlusions, body burden and waste.
−Removed: In support of this effort, we are currently developing unique extended wear infusion set technology.
−Removed: Device Software
−Removed: Our device software is used to control our pumps either directly through the pump’s interface or through our mobile application.
−Removed: It also includes our AID technology, and the software used to support remote pump updatability.
+Added: In support of this effort, unique extended wear infusion set technology is expected to be part of our future portfolio.
Control-IQ Advancements
We are continuing to drive innovation in our algorithms, emphasizing automation, personalization and simplification to continue to improve therapeutic outcomes and provide a positive patient experience.
−Removed: We have recently completed clinical studies to support expanding the indications of our Control-IQ technology to include people with type 1 diabetes ages 2 to 5 years old.
−Removed: Additionally, we are initiating a pivotal study to support expanding indications to include people living with type 2 diabetes.
+Added: In 2023, we began a pivotal study to support expanding indications to include people living with type 2 diabetes.
+Added: In late 2023, our Control-IQ technology was cleared with additional features for people with type 1 diabetes age 2 and older.
We are also researching the use of different insulins with our Control-IQ technology.
−Removed: Mobile Control
−Removed: We are working to expand our mobile control capability.
−Removed: In the future, our t:connect mobile app is planned to include additional pump control features, such as full operation of our Mobi pump.
−Removed: Building a robust ecosystem and portfolio around our flagship insulin pumps requires product development efforts to integrate, add and enhance complementary system components.
−Removed: We have agreements with Dexcom to extend our current collaboration to include integration with their G7 CGM technology.
−Removed: Following integrated product development work, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices.
−Removed: We have an agreement with Abbott Laboratories (Abbott), to develop and commercialize integrated diabetes solutions that combine Abbott’s FreeStyle Libre CGM technology with our insulin delivery systems.
−Removed: Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in the U.S.
−Removed: and Canada, with additional geographies considered in the future.
−Removed: Data and Insights
−Removed: Our goal is to innovate across our digital health platforms by using the vast amount of data that we collect, in combination with technology such as artificial intelligence or machine learning, to provide information and insights to people living with diabetes, their caregivers and healthcare providers and insurance payors.
−Removed: Our key objectives include making these insights easy to understand, making the data available in real time, and providing the information in a flexible format with mobile or web apps.
−Removed: In addition, we are working to integrate health-related information from third-party sources and to use our data to support current and future products under development.
−Removed: Tandem Source
−Removed: Expanding the capabilities of our t:connect data management application available for customers in the United States, Tandem Source is our second-generation web-based data management application that is being designed to be deployed globally.
−Removed: This application enhances clinical data visualization, and provides added interface customization for users to personalize how they engage with their data and for healthcare providers to better manage their care.
−Removed: We continue to develop and test new features for Tandem Source in anticipation of a future commercial release of the product.
−Removed: Settings Automation
−Removed: Our automation research and development activities center around opportunities for enhanced user and healthcare provider experience, and improved clinical outcomes.
−Removed: In support of this effort, we are working to automate our pump settings adjustments to further enhance ease of use and expand adoption of our insulin pump products.
Markets and Distribution Methods
−Removed: The t:slim X2 insulin delivery system is now available in approximately 25 countries worldwide.
−Removed: In the United States and Canada, we employ a direct sales and clinical organization.
−Removed: This organization is augmented by individuals in our internal customer sales support organization, who follow up with existing customers who are approaching their insurance renewal date to aid in the renewal process and on leads generated through promotional activities.
−Removed: Outside the United States, we have contracted with distributors who have substantial responsibility for sales, marketing and customer support efforts.
+Added: Our technology solutions are now available in the following 25 countries:
+Added: United Kingdom
+Added: Czech Republic
+Added: United States
+Added: In the United States and Canada, we employ direct sales, customer support, and clinical teams.
+Added: We also partner with independent distributors for order fulfillment.
+Added: Outside the United States and Canada, we contract with distributors who have substantial responsibility for sales, customer support, clinical efforts and order fulfillment.
Revenue Concentrations and Significant Customers.
−Removed: A small number of independent distributors in the United States have historically accounted for a significant portion of our revenues.
−Removed: Generally, our five largest distributors account for approximately 40% of consolidated sales.
−Removed: We believe our distributors in the United States carry minimal inventory at any given time.
−Removed: Outside the United States, there may be variability in inventory levels among our distributors, particularly when they first commence product sales or surrounding the launch of new products.
−Removed: Training and Customer Care .
−Removed: In the United States and Canada, our customer care infrastructure consists of specialists focused on product training, pump and supply order processing and 24/7/365 technical services.
−Removed: We also provide training and technical services to our distribution partners who fulfill their customer care responsibilities outside the United States.
+Added: A small number of independent distributors in the United States and Canada are responsible for order fulfillment.
+Added: We believe these distributors carry minimal inventory at any given time.
+Added: Outside the United States and Canada, there may be variability in inventory levels among our distributors, particularly when they first begin product sales or surrounding the launch of new products.
+Added: For the year ended December 31, 2023, two independent distributors each accounted for more than 10% of our worldwide sales.
Third-Party Reimbursement
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We are accredited by the Community Health Accreditation Program and are an approved Medicare provider.
−Removed: We enter into contracts with national and regional third-party payors to establish reimbursement for our insulin pump products, disposable insulin cartridges and other related supplies.
+Added: We enter into contracts with national and regional third-party payors to establish reimbursement for our insulin pump products, single-use insulin cartridges and other related supplies.
If we are not contracted with a prospective customer’s third-party payor and in-network status cannot be otherwise obtained, then to the extent possible we use distribution channels so our customers’ orders can be serviced.
While we have been working to increase our sales in the United States through our direct third-party payor contracts, the percentage is currently less than half of total sales.
+Added: A third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved.
+Added: Further, coverage policies and third-party reimbursement rates may change at any time.
+Added: Even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.
Outside of the United States and Canada, our distribution partners are responsible for all reimbursement, tender application and fulfillment activities.
Manufacturing and Quality Assurance
−Removed: Our pump products are currently assembled, tested and packaged at our facilities in San Diego, California.
−Removed: Over the course of the last two years, we have been transitioning our t:slim cartridge manufacturing to an experienced third-party contract manufacturer to provide us additional flexibility in scaling our business while creating additional leverage.
−Removed: We also use external third parties to sterilize our finished cartridges.
−Removed: All finished cartridges are packaged for sale at our facilities in San Diego.
+Added: Our t:slim X2 pumps, and Tandem Mobi pumps and cartridges, are currently assembled, tested, and packaged at our facilities in San Diego, California.
+Added: Our t:slim X2 cartridges are manufactured by an experienced third-party contract manufacturer and packaged at our facilities in San Diego.
Outside suppliers are the source for components and some sub-assemblies in the production of our insulin pumps and cartridges.
−Removed: In addition, we purchase all of our currently marketed infusion sets from a third-party supplier, Unomedical A/S, a subsidiary of ConvaTec Group.
+Added: In addition, we purchase all of our currently marketed infusion sets from a third-party supplier, Unomedical A/S, a subsidiary of the ConvaTec Group.
Unomedical is responsible for all manufacturing, testing, sterilization and packaging of the infusion sets under our brands.
Any sole and single source supplier is managed through our supplier management program that is focused on reducing supply chain risk.
−Removed: Our suppliers are evaluated, approved and monitored periodically by our quality department to ensure conformity with the specifications, policies and procedures applicable to our devices.
−Removed: Members of our quality department also inspect our devices at various steps during the manufacturing cycle to facilitate compliance with our devices’ stringent specifications.
+Added: Certain of our suppliers are evaluated, approved and monitored periodically by our quality department to ensure conformity with the specifications, policies and procedures applicable to our devices.
+Added: Members of our quality department also inspect certain of our devices at various steps during the manufacturing cycle to facilitate compliance with our devices’ stringent specifications.
+Added: We purchase our raw materials and select components used in the manufacturing of our products from external suppliers.
+Added: We purchase some supplies from a single or limited number of sources for reasons of proprietary know-how, quality assurance, cost-effectiveness, or constraints resulting from regulatory requirements.
+Added: We work closely with our suppliers to help ensure continuity of supply while maintaining high quality and reliability.
+Added: However, due to required medical device manufacturing qualification requirements, we may not be able to quickly establish additional or replacement sources.
+Added: In the case of sole sourced parts, we manage risk through holding inventory in-house and at the supplier to ensure continuity of supply and lower risk of disruption.
+Added: We purchase many of our components and sub-assemblies from manufacturers with whom we are at least dual sourced.
+Added: We work closely with all suppliers to ensure continuity of supply while maintaining high quality and reliability.
We have received certification from BSI Group, a Notified Body to the International Standards Organization (ISO), of our quality system.
−Removed: 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.
−Removed: As a medical device manufacturer, our manufacturing facility and the facilities of our sterilization and other critical suppliers are subject to periodic inspection by the FDA and certain corresponding state agencies.
+Added: A Notified Body is an entity that has been designated and accredited by the national competent authority of an EU Member State in accordance with applicable EU legislation to perform third-party conformity assessment activities including calibration, testing, certification and inspection of a medical device.
+Added: Certain processes used in the manufacturing and testing of our devices have been verified and validated as required by the FDA and other regulatory bodies.
+Added: As a medical device manufacturer, our manufacturing facility and the facilities of our sterilization and other critical suppliers are subject to periodic inspection by the FDA, certain corresponding state agencies, and Notified Bodies and foreign regulatory authorities.
Intellectual Property
3 unchanged sentences
and other countries, which in the aggregate, we believe to be important to our business.
−Removed: Patents are generally effective for 20 years from the date the earliest application was filed, and in some cases may be extended.
+Added: Patents are generally effective for 20 years from the date the earliest application was filed in the patent family, and in some cases may be extended.
Our issued patents as of December 31, 2023 are set to expire over a range of years, from 2024 to 2042, subject to any extensions.
2 unchanged sentences
In addition, we have entered into exclusive and non-exclusive licenses in the ordinary course of business relating to a wide array of technologies or other intellectual property rights or assets.
+Added: Our patents and patent applications seek to protect aspects of key features of our pumps, cartridges, algorithms and pump systems.
+Added: We believe that our patent position provides us with sufficient rights to protect our current and proposed commercial products.
+Added: However, our patent applications may not result in issued patents, and any patents that have been issued or might be issued may not protect our intellectual property rights.
+Added: Furthermore, we operate in an industry characterized by extensive patent litigation, and our patents may not be upheld if challenged.
+Added: Any patents issued to us may be challenged by third parties as being invalid or unenforceable, and patent litigation may result in significant damage awards and injunctions that could prevent the manufacture and sale of affected products or result in significant royalty payments to continue selling the products.
+Added: Third parties may also independently develop similar or competing technology that avoids our patents.
+Added: The steps we have taken may not prevent the misappropriation of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the United States.
+Added: We also face risks associated with intellectual property infringement.
+Added: We also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position.
+Added: We seek to protect our proprietary information and other intellectual property by generally requiring our employees, consultants, contractors, suppliers, outside scientific collaborators and other advisors to execute non-disclosure and assignment of invention agreements at the start of their employment or engagement.
+Added: Agreements with our employees also forbid them from bringing the proprietary rights of third parties to us.
+Added: We also generally require confidentiality or material transfer agreements from third parties that receive our confidential data or materials.
+Added: We cannot guarantee that employees and third parties will abide by the confidentiality or assignment terms of these agreements.
+Added: Despite measures taken to protect our intellectual property, unauthorized parties might copy aspects of our products or obtain and use information that we regard as proprietary.
The medical device industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products, treatment techniques or technologies, or other market activities of industry participants.
−Removed: We compete in markets worldwide with two primary companies that manufacture insulin delivery devices.
−Removed: 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.
−Removed: market, including insulin pumps and Bluetooth-enabled insulin pens to support MDI therapy.
−Removed: Additionally, several other companies currently market insulin pump products in markets outside the U.S.
+Added: We compete in markets worldwide with companies that manufacture insulin delivery devices, primarily Insulet, Medtronic and Ypsomed.
+Added: There are also a number of other companies developing and marketing their own insulin delivery systems and/or related software applications for launch both in the U.S.
+Added: market and outside the U.S., including insulin pumps and Bluetooth-enabled insulin pens to support MDI therapy.
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.
Government Regulation
+Added: Regulation of Medical Devices in the United States
Our products are medical devices subject to extensive regulation by the FDA in the United States, corresponding state regulatory authorities and other regulatory bodies in other countries.
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Federal Food, Drug and Cosmetic Act (FDCA), also referred to as a 510(k) clearance, or approval from the FDA through the premarket approval (PMA) process.
−Removed: We have obtained clearance on multiple devices in both Class II and Class III, including Control IQ and the tslim:X2.
+Added: We have obtained clearance on multiple devices in both Class II and Class III, including Control IQ, the tslim:X2 and Tandem Mobi.
510(k) Clearance .
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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).
−Removed: 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 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 type 1 diabetes age 6 and older by connecting to an ACE pump and iCGM.
+Added: In November 2023, our Control-IQ technology was cleared with additional features for people with type 1 diabetes age 2 and older.
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.
−Removed: In March 2020, our Basal-IQ technology was also cleared as an iAGC.
−Removed: 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.
−Removed: PMA Application:
−Removed: For Class III devices a PMA application must be supported by valid scientific evidence that typically includes extensive technical, pre-clinical, clinical, manufacturing and labeling data to demonstrate to the FDA’s satisfaction the safety and efficacy of the device.
−Removed: During the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA.
−Removed: In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to evaluate compliance with QSR, which requires manufacturers to implement and follow design, testing, control, documentation and other quality assurance procedures.
−Removed: FDA review of a PMA application generally takes approximately one year but may take significantly longer.
−Removed: If an FDA evaluation of a PMA application is favorable, the FDA will issue either an approval letter, or approvable letter, which usually contains a number of conditions that must be met in order to secure final approval of the PMA.
−Removed: When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of a device, subject to the conditions of approval and the limitations established in the approval letter.
−Removed: If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not-approvable letter.
−Removed: The FDA also may determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA.
−Removed: The PMA process can be expensive, uncertain and lengthy and a number of devices for which FDA approval has been sought by other companies have never been approved by the FDA for marketing.
−Removed: New PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that has been approved through the PMA process.
−Removed: PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive technical or clinical data or the convening of an advisory panel.
+Added: 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 application, which must be supported by valid scientific evidence that typically includes extensive technical, pre-clinical, clinical, manufacturing and labeling data to demonstrate to the FDA’s satisfaction the safety and efficacy of the device.
Clinical trials are typically required to support a PMA application and are sometimes required for a 510(k) clearance.
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Physician Self-Referral Law .
−Removed: The Stark Law prohibits a physician from referring Medicare or Medicaid patients to an entity providing “designated health services,” including a company that furnishes durable medical equipment, if the physician has a financial relationship with the company.
+Added: The Stark Law prohibits a physician from referring Medicare or Medicaid patients to an entity providing “designated health services,” including a company that furnishes durable medical equipment, if the physician or their immediate family member has a financial relationship with the company.
In addition to statutory exceptions, the Centers for Medicare and Medicaid Services (CMS), has issued numerous regulatory exceptions to the Stark Law.
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However, because we cannot guarantee that the government or qui tam relators will regard any billing errors that may be made as inadvertent, or our provider relationships as compliant, we may have exposure under the False Claims Act.
−Removed: Federal Health Care Fraud Statutes.
−Removed: We are also subject to a federal health care fraud statute that, among other things, imposes criminal and civil liability for executing a scheme to defraud any health care benefit program including non-governmental programs, and prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false or fraudulent statement or representation, or making or using any false writing or document with knowledge that it contains a materially false or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.
State Fraud and Abuse Provisions.
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Data Privacy and Information Security Laws and Regulations.
−Removed: 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 (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 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.
−Removed: General Data Protection Regulation, commonly known as GDPR, and similar E.U.
+Added: Our use of t:connect and Tandem Source data is subject to internal policies and procedures that are designed to comply with the federal U.S.
+Added: Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as applicable U.S.
+Added: state privacy laws HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), imposes certain requirements on covered entities, which include certain healthcare providers, health plans and healthcare clearinghouses, and their business associates and covered subcontractors that receive or obtain protected health information in connection with providing a service on behalf of a covered entity relating to the privacy, security and transmission of individually identifiable health information.
+Added: Although t:connect, t:connect HCP and Tandem Source 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.
+Added: and United Kingdom (U.K.) General Data Protection Regulation, collectively known as GDPR, and similar E.U.
member state laws.
−Removed: Collectively, these laws and regulations set standards for safeguarding the confidentiality, integrity, and availability of the personal information we collect and use from customers and healthcare providers.
−Removed: These laws also require, among other things, that we are transparent about how we collect and share personal data and that we give t:connect users the ability to know what data we are collecting about them, to obtain a copy of that data, to correct or amend that data, and to request we restrict use of that data.
+Added: Collectively, these laws and regulations set standards that may be applicable to us regarding safeguarding the privacy and security of the personal information we collect and use from customers, healthcare providers and other individuals.
+Added: These laws also require, among other things, publication of privacy notices detailing certain data collection and sharing practices and extension of certain rights to individuals, such as the right to know what data is collected about them, to obtain a copy of that data, to correct or amend that data, and to request restricted use of that data.
Healthcare Fraud .
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Physician Payments Sunshine Act .
−Removed: The Physician Payments Sunshine Act requires certain manufacturers, including medical device manufacturers, to submit annual data pertaining to payments or other transfers of value to covered recipients, including physicians.
+Added: The Physician Payments Sunshine Act requires certain manufacturers, including medical device manufacturers, to submit annual data to CMS pertaining to payments or other transfers of value to covered recipients, including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members.
Manufacturers may be subject to audit for their compliance with this law.
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We believe we are in substantial compliance with the Physician Payments Sunshine Act to date.
−Removed: However, the reporting requirements were meaningfully expanded beginning in 2021 and we implemented additional processes and controls in order to comply with these new tracking and disclosure obligations.
Anti-Bribery and Anti-Corruption Laws.
7 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 the European Union, which includes most of the major countries in Europe.
−Removed: Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices.
−Removed: The European Union has adopted numerous directives and standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices.
−Removed: These directives are in the process of being replaced by the Medical Device Regulation.
−Removed: 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.
−Removed: 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.
−Removed: An assessment by a Notified Body of one country within the European Union is required in order for a manufacturer to commercially distribute the product throughout the European Union.
−Removed: Additional local requirements may apply on a country-by-country basis.
−Removed: 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: We have obtained the right to affix the CE Mark to the t:slim X2 Insulin Delivery System, which allows us to distribute this product throughout the European Union and in other countries that recognize the CE Mark.
+Added: Regulation of Medical Devices in the European Economic Area
+Added: On 26 May 2021, Regulation (EU) 2017/745 on Medical Devices, or the Medical Device Regulation, entered into application, repealing and replacing both Directive 93/42/EEC concerning medical devices, or MDD, and Directive 90/385/EEC concerning active implantable medical devices, or AIMD.
+Added: The Medical Device Regulation and its associated guidance documents and harmonized standards govern, among other things, device design and development, preclinical and clinical or performance testing, premarket conformity assessment, registration and listing, manufacturing, labeling, storage, claims, sales and distribution, export and import and post-market surveillance, vigilance, and market surveillance.
+Added: Medical devices must comply with the General Safety and Performance Requirements, or GSPRs, set out in Annex I of the Medical Device Regulation.
+Added: Compliance with these requirements is a prerequisite to be able to affix the CE mark to devices, without which they cannot be marketed or sold in the European Economic Area (comprised of the 27 EU Member States, Iceland, Liechtenstein and Norway).
+Added: To demonstrate compliance with the GSPRs provided in the Medical Device Regulation and obtain the right to affix the CE mark, medical devices manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
+Added: Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer may issue an EU Declaration of Conformity based on a self-assessment of the conformity of its products with the GSPRs, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.
+Added: Depending on the relevant conformity assessment procedure, the Notified Body audits and examines the technical documentation and the quality system for the manufacture, design and final inspection of the medical devices.
+Added: The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the GSPRs.
+Added: This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EU Declaration of Conformity.
+Added: As a general rule, demonstration of conformity of medical devices and their manufacturers with the GSPRs must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
+Added: Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and
+Added: safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence.
+Added: This assessment must be based on clinical data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated or (3) both clinical studies and scientific literature.
+Added: The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.
+Added: These may include the requirement of prior authorization by the Competent Authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee.
+Added: This process can be expensive and time-consuming.
+Added: After a device is placed on the market, it remains subject to significant regulatory requirements.
+Added: The Medical Device Regulation provides transitional provisions, amended by Regulation (EU) 2023/603.
+Added: Accordingly, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from 25 May 2017, and which remained valid on 26 May 2021 and have not since been withdrawn will, with certain exceptions, remain valid until 31 December 2027 for Class III and Class IIb implantable medical devices and until 31 December 2028 for other Class IIb, Class IIa and Class I devices with a measuring function or which are sterile.
+Added: Class I medical devices, for which the conformity assessment procedure in accordance with the MDD or the AIMD did not require the involvement of a Notified Body but will require the involvement of a Notified Body in accordance with the Medical Device Regulation and for which an EU Declaration of Conformity was issued in accordance with the MDD or the AIMD before 26 May 2021, can continue to be placed on the EEA market until 31 December 2028.
+Added: Manufacturers of medical devices may only benefit from the above extended transitional provisions deadlines if the following conditions are fulfilled:
+Added: (i) the devices continue to comply with the requirements of the MDD or AIMD, (ii) there are no significant changes in the design and intended purpose, (iii) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, (iv) the manufacturer implements a quality management system by 26 May 2024 which complies with the requirements of the Medical Devices Regulation, (v) by 26 May 2024 an application is lodged with a Notified Body for conduct of the conformity assessment of the devices covered by the CE Certificate of Conformity, or the devices intended to substitute for such devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by 26 September 2024, and (vi) from 26 May 2021, compliance with the Medical Device Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices is ensured in place of the corresponding requirements in the MDD or AIMD.
+Added: In addition, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from 25 May 2017, which were valid on 26 May 2021 and have not been withdraw since but which expired before 20 March 2023, will only continue to be valid in accordance with the extended transitional deadlines above if either (i) the manufacturer signed a written agreement with a Notified Body for the conformity assessment of the device covered by the expired CE Certificate of Conformity, or the device intended to substitute that device, in accordance with the Medical Device Regulation before the date of expiry of the CE Certificate of Conformity, or (ii) a competent authority of an EEA country has granted a derogation from the application conformity assessment procedure in accordance with Article 59(1) or Article 97(1) of the Medical Device Regulation.
+Added: Class III custom-made implantable medical devices may be placed on the market until 26 May 2026 without a CE Certificate of Conformity issued by Notified Body, provided that (i) by 26 May 2024, an application is lodged with a Notified Body for the conformity assessment of the devices, in accordance with the Medical Device Regulation and a related written agreement is signed with the Notified Body by 26 September 2024.
+Added: The advertising and promotion of medical devices in the EU is subject to the national laws of the individual EEA country that implemented the MDD, the AIMD and that apply the Medical Device Regulation, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EEA countries governing the advertising and promotion of medical devices EEA countries’ national legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.
+Added: In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.
+Added: Outside of the European Union, regulatory approval would need to be sought on a country-by-country basis for us to market our products.
+Added: We have obtained the right to affix the CE Mark to the t:slim X2 Insulin Delivery System, which allows us to distribute this product throughout the European Union.
+Added: We may also leverage the CE Mark in certain other countries to fulfill the national applicable regulatory requirements for placing our product on national markets.
In addition, we have Health Canada approval to sell the t:slim X2 in Canada.
−Removed: A range of anti-bribery and anti-corruption laws, as well as industry specific laws and codes of conduct, apply to the medical device industry and interactions with government officials and entities and healthcare professionals.
+Added: Outside the United States, interactions between medical device companies, government officials and health care professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.
These laws include the U.K.
−Removed: Bribery Act and similar antibribery laws in other jurisdictions in which we operate.
−Removed: Such laws generally prohibit U.S.-based companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business to foreign officials, or in the case of the U.K.
+Added: Bribery Act and similar anti-bribery laws in other jurisdictions in which we operate.
+Added: Such laws generally prohibit U.S.-
+Added: based companies and their intermediaries from making improper payments for the purpose of obtaining or retaining business to foreign officials, or in the case of the U.K.
Bribery Act, to any person.
−Removed: General Data Protection Regulation.
−Removed: The General Data Protection Regulation (“GDPR”) is a comprehensive update to the data protection regime in the European Economic Area that imposes requirements relating to, among other things, consent to process personal data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches and use of third-party processors.
−Removed: If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties for noncompliance.
Environment, Social and Governance
−Removed: We have a focused effort on understanding the environmental impact of our business, both the direct impact as an employer and manufacturer, as well as the impact resulting from consumer use of the products we offer.
−Removed: We have metrics and initiatives across the business in support of these efforts, and our company goals include driving economic efficiencies and process improvement, with environmental impact in mind.
+Added: Our Board of Directors and management team believe that environmental stewardship, social responsibility, and solid corporate governance are important to our business strategy and long-term value creation for our shareholders, employees, customers, and communities.
+Added: The Nominating and Corporate Governance Committee of our Board oversees ESG matters across our business operations in accordance with its charter.
+Added: Our management team is responsible for developing and driving strategic ESG initiatives and programs across our business and providing regular updates on progress to the Nominating and Corporate Governance Committee.
Additional information about our Environmental, Social and Governance practices can be found on our website within the “Investor Center” section.
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The term “employees” in this Annual Report means our regular full-time employees.
−Removed: 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: Our headquarters are in San Diego, California, where our primary research and development and administrative headquarters are located, and where we also operate a manufacturing facility and a warehousing facility.
None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
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Our Words We Live By describe our core values and reflect who we are and the way our employees interact with one another, our customers, partners and stockholders.
−Removed: In both 2021 and 2022, we conducted employee engagement surveys through Gallup, a leading global consulting firm on employee engagement.
−Removed: More than 90% of our employees participated in both years, and the results demonstrated that our overall engagement levels exceed Gallup’s averages worldwide, in the United States, and in life sciences.
+Added: In 2021, we began conducting employee engagement surveys through Gallup, a leading global consulting firm on employee engagement.
+Added: More than 90% of our employees have participated each year, and the results demonstrated that our overall engagement levels exceed Gallup’s averages worldwide and in the United States.
+Added: In addition, we exceeded overall engagement in the professional, scientific and technical sector, as well as the life sciences sector.
The results also reflected that we are a mission-driven company with employees’ response on our strength of purpose far exceeding Gallup’s measurement for world class.
−Removed: In 2022, we earned the Great Place to Work Certification, a prestigious award based entirely on results from in-depth employee surveys around their experience working at the Company.
−Removed: This certification is the most definitive “employer-of-choice” recognition that companies aspire to achieve and is recognized worldwide by employees and employers alike and is the global benchmark for identifying and recognizing outstanding employee experience.
Diversity, Equity and Inclusion
−Removed: Our diversity, equity and inclusion (DE&I) goals focus on cultivating and encouraging an inclusive and equitable culture where diversity of thought is represented and can thrive throughout our organization.
+Added: Our diversity, equity and inclusion (DE&I) efforts focus on cultivating and encouraging an inclusive and equitable culture where diversity of thought is represented and can thrive throughout our organization.
More than half of our employees are female, includin g 30% of o ur employees at the Vice President level or higher, and approximately half of our employees are from an underrepresented ethnic community.
We believe that bringing together different perspectives and experiences is fundamental to innovation and continuing to raise the bar in the field of diabetes technology.
−Removed: 2021 was our first full year of having a DE&I Council, which we continued and expanded during 2022.
+Added: 2021 was our first full year of having a DE&I Council, which we have continued to expand since that time.
This Council is sponsored by executive management and we provide regular updates to our Board of Directors on its initiatives and progress.
It is staffed by employees with diverse backgrounds, experiences or characteristics who share a common interest in professional development, improving corporate culture and delivering sustained business results.
+Added: In 2023, our first employee resource groups were formed and focus on supporting populations within Tandem including women and gender minorities, LGBTQIA+, Pacific Islander or Asians, parents and caregivers, and in enhancing Tandem’s sustainability efforts.
Our DE&I efforts are focused on diabetes representation and access, representation in leadership, representation in technology roles and pro-inclusion.
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More than 95% 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.
−Removed: In 2022, more than 450 employees participated in our leadership development programs.
+Added: In 2023, approximately 400 employees participated in our leadership development programs.
Competitive Total Rewards
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For example, as a benefit to our employees and their eligible dependents, we provide access to personal and job-related counseling and assistance resources for addressing concerns such as emotional well-being, family and relationships, legal and financial matters, healthy lifestyles, mental health, substance abuse, and work and life transitions.
−Removed: 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 have comprehensive safety training programs that teach our employees how to do their jobs safely and in compliance with laws and regulations.
We operate in modern, efficient, and safe facilities, and have had minimal accident and injury rates company wide.
1 unchanged sentence
zero accidents.
−Removed: Throughout the COVID-19 global pandemic, we were deemed an essential healthcare business under applicable governmental orders, and our manufacturing and warehousing sites continued operating during the COVID-19 pandemic.
−Removed: As such, we invested in creating physically safe work environments for our employees through the implementation of new protocols, trainings and communications.
−Removed: Information about our Executive Officers
−Removed: Name Age Title
−Removed: Sheridan 67 President and Chief Executive Officer
−Removed: Berger 53 EVP and Chief Operating Officer
−Removed: Carpenter 59 Chief Technical Officer
−Removed: Gasser 47 EVP and Chief Strategy Officer
−Removed: Hansen 55 EVP and Chief Commercial Officer
−Removed: Hansen 57 SVP, General Counsel, Chief Compliance Officer and Secretary
−Removed: James Leal 59 SVP, Operations
−Removed: Morrison 43 EVP and Chief Administrative Officer
−Removed: Vosseller 50 EVP, Chief Financial Officer, and Treasurer
−Removed: Further detailed information about our executive officers not referenced or set forth above, is provided in our definitive Proxy Statement for our 2022 Annual Meeting of Stockholders and will be included in our definitive Proxy Statement for our 2023 Annual Meeting of Stockholders and is incorporated herein by reference.
−Removed: Family Relationships
−Removed: Sheridan, our President and Chief Executive Officer, and Ms.
−Removed: Vosseller, our Executive Vice President, Chief Financial Officer and Treasurer, are involved in a personal relationship and share a primary residence.
−Removed: Vosseller reports directly to Mr.
−Removed: Our board of directors is informed of the relationship and due to the direct reporting arrangement, we have taken appropriate actions to ensure compliance with Company policies and procedures.
−Removed: Sheridan and Ms.
−Removed: Vosseller will not be involved in setting compensation or benefits for one another, which will continue to be determined by our Compensation Committee.
−Removed: In addition, our Audit Committee of the Board of Directors considered whether additional internal disclosure controls and procedures are appropriate in light of the circumstances and, as a result, certain additional internal controls were implemented during the year ended December 31, 2019.
−Removed: Except as described above, there are no family relationships between any of our directors and executive officers.
Additional Information
Our website address is www.tandemdiabetes.com .
−Removed: Copies of our filings with the SEC are available free of charge on our website within the “Investor Center” section as soon as reasonably practicable after having been electronically filed with or furnished to the SEC.
+Added: Copies of our filings with the SEC, including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), are available free of charge on our website within the “Investor Center” section as soon as reasonably practicable after having been electronically filed with or furnished to the SEC.
The information contained on or accessed through our website does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references only.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.