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Item 1. Business

2026-02-19 compared with 2025-02-26 · 153 added, 162 removed, 195 unchanged (62% of the section changed)

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.

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.

Our pump portfolio features the Tandem Mobi and t:slim X2, both of which feature Control-IQ advanced hybrid closed-loop technology.

Our headquarters are in San Diego, California.

We consider our primary addressable market to be people who live with type 1 diabetes.

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.

Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team, by offering flexibility and choice in intelligent insulin delivery systems through an accessible portfolio of market-leading pumps, applications, and insights.

The t:slim X2 Insulin Delivery System has been our flagship technology solution.

In February 2024, we expanded our pump portfolio with the United States launch of Tandem Mobi.

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.

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.

In addition, they are software-updatable from a personal computer and compatible with our web-based data management application.

In the four-year period ended December 31, 2024, we shipped more than 480,000 insulin pumps, which is representative of our in-warranty global installed customer base assuming the typical four-year reimbursement cycle.

Approximately 320,000 pumps were shipped to customers in the United States and approximately 160,000 were shipped to customers outside the United States.

Tandem Diabetes Care is a global leader in insulin delivery and diabetes technology, specializing in the design, development, and commercialization of advanced solutions that reduce the burden of diabetes management.

We serve nearly 500,000 people living with diabetes in more than 25 countries worldwide.

Our strategy is to offer flexibility and choice in intelligent insulin delivery systems through an accessible portfolio of market-leading pumps, applications and insights.

In support of this strategy, our Tandem pump platforms include t:slim X2 and Tandem Mobi (Mobi), both of which feature Control-IQ+ advanced hybrid closed-loop technology.

Diabetes and the Insulin Therapy Management Market

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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 type 1 diabetes and we are also seeking to expand our addressable market to include people living with type 2 diabetes who require intensive insulin therapy.

We consider our addressable market to be people living with type 1 diabetes and in 2025, we began expanding our addressable market to include people living with type 2 diabetes who require intensive insulin therapy.

Throughout this Annual Report, we refer to these individuals as people with insulin-dependent diabetes.

In the geographies we serve, we estimate more than 5 million people live with type 1 diabetes of whom, approximately 2 million reside in the United States.

We estimate nearly 2.5 million people in the United States live with type 2 diabetes and require intensive insulin therapy.

Diabetes can be difficult for patients to manage.

In the geographies we serve, we estimate about 5 million people live with type 1 diabetes of whom approximately 2 million reside in the United States.

We estimate about 2.5 million people in the United States live with type 2 diabetes and require intensive insulin therapy.

Diabetes can be challenging to manage.

Unlike most therapies, insulin requirements can vary greatly and can be affected by many factors, such as type or quantity of food eaten, illness, stress and exercise.

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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.

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.

By comparison, there are also disposable pumps which combine the pump mechanism, battery and electronics with the cartridge and infusion set into a body-worn patch.

These pumps are entirely disposed of by the user every 3 days.

Approximately 2.2 million people worldwide are estimated to use an insulin pump to manage their diabetes.

We estimate that approximately 900,000 people in the United States use an insulin pump, of whom approximately 85% live with type 1 diabetes.

Insulin pump therapy can provide benefit 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.

Insulin pump systems are typically considered either durable or disposable.

Durable systems are comprised of a programmable device, which is designed to last for multiple years, and which connect to single-use supplies that provide an insulin reservoir and cannula to administer insulin into the body that are expected to be replaced every three to seven days.

By comparison, disposable systems combine the programmable device, which includes battery and electronics, with the insulin reservoir and cannula and are entirely disposed of by the user every three days.

In both systems, the insulin reservoir is typically filled by the user.

Insulin pumps often feature automated insulin delivery (AID) algorithms, which use continuous glucose monitoring (CGM) sensor information to automatically adjust insulin dosing, and are designed to improve blood glucose control and increase a user’s time in their targeted glycemic range, while reducing the burden of diabetes management.

The American Diabetes Association Standards of Care state that diabetes devices should be offered to people with diabetes.

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.

The worldwide insulin pump market remains highly underpenetrated.

In the United States, approximately 40% of individuals with Type 1 diabetes, and 5% of individuals with Type 2 diabetes, use insulin pump therapy.

Internationally, average insulin pump adoption is estimated to be approximately 20%.

Our Technology:

Improving the Lives of People with Insulin-Dependent Diabetes

We develop our insulin pump technology and related product offerings using a consumer-focused approach.

Our AID Systems

We develop our automated insulin delivery systems and related technology solutions using a consumer-focused approach.

We initially rely on the use of behavioral sciences, including extensive research to ascertain what people with insulin-dependent diabetes require and prefer from their diabetes therapy.

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.

Our insulin pumps are generally considered durable medical equipment and have an expected lifespan of at least four years.

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.

We launched our flagship t:slim platform in August 2012, and its next generation, the t:slim X2, in October 2016.

In February 2024, we expanded our offerings with the commercial availability of Tandem Mobi in the United States.

Both pumps are fully detachable, offer Bluetooth connectivity and can be used as part of an automated insulin delivery system.

This multi-step approach has resulted in a differentiated device portfolio that provide users with the distinct features and functionality they seek and in a manner that makes the features usable and intuitive.

We offer durable insulin pumps that are designed for years of daily use.

We sell single-use supplies that are used together with our pumps and are replaced every few days.

These supplies include cartridges for storing insulin, and infusion sets that contain a cannula and connect the pump to a user’s body to administer insulin.

We launched our flagship t:slim pump platform in August 2012, and its next generation, the t:slim X2, in October 2016.

In 2024, we expanded our portfolio with the commercial availability of Mobi with iOS control in the United States.

In December 2025, we further expanded the availability of Mobi to Android users in the U.S.

Our insulin pumps are fully detachable, offer Bluetooth connectivity and are typically used as part of an AID system.

Control-IQ Technology

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Pump Button for Bolus Delivery

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.

Control-IQ was the first AID algorithm cleared by the FDA to deliver automatic correction boluses in addition to adjusting basal insulin to help prevent high and low blood sugar.

Control-IQ technology offers optional settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.

Results from 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.

As part of our AID systems, we offer pump integration with multiple CGM sensors, which helps provide customizable solutions for people living with diabetes.

The Dexcom G7 sensor is the fourth generation of Dexcom’s CGM that we have integrated with our pump technology since 2015.

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.

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.

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.

When used as an AID system, our insulin pumps are integrated with a CGM and powered by our Control-IQ+ technology.

Results from four independent pivotal studies using Control-IQ technology have been published in the New England Journal of Medicine since 2019.

Control-IQ+ launched in 2025 and is our third and newest AID algorithm, which is available globally and indicated for people as young as ages 2+ (type 1).

It is also indicated for people 18+ (type 2) in the United States.

This hybrid closed loop algorithm increases a user's time in targeted glycemic range (70-180 mg/dL) by predicting and helping to prevent the frequency and/or duration of hyperglycemic and/or hypoglycemic events.

It is the only predictive algorithm featuring AutoBolus, corrective bolusing.

Control-IQ+ also offers an easy set-up feature and settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.

Our AID systems offer users the choice of integrating with multiple CGM sensors.

In 2025, our pumps integrated with sensors such as the Dexcom G6 and G7, and the Abbott FreeStyle Libre 2 Plus.

In December 2025, we launched t:slim X2 integration with Abbott FreeStyle Libre 3 Plus in the U.S.

Mobi was available with Dexcom G6 and G7 integration in the U.S., and we plan to expand its integration offerings to include Abbott FreeStyle Libre 3 Plus.

Our extensive experience in CGM integration over the past decade represents our commitment to provide customizable solutions to help reduce burden and create new possibilities for people living with diabetes.

Tandem Device Updater

This tool allows our pump users to update their pump software quickly and easily from a personal computer.

This tool allows Tandem pump users to update their pump software quickly and easily from a personal computer.

It is PC and Mac compatible and designed to work with our pumps in a manner similar to software updates on a smartphone.

We have used this technology to offer our in-warranty customers worldwide software updates at no cost.

We have used this technology worldwide to offer software updates to our in-warranty customers at no cost.

Tandem Source

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 and integrated CGMs.

In 2023, Tandem Source was launched in the United States and in 2024 we began scaling its launch outside the United States.

Tandem Source 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.

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.

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.

Tandem Source is available in the majority of markets we serve globally and was 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.

It offers automatic data transfers from pumps using a mobile app to keep online data current and remove the need for manual pump uploads.

Sugarmate is a mobile app that is designed to help people visualize diabetes therapy data in innovative ways.

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Our Strategy & Future Technologies

Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences.

Our goal is to redefine global leadership in insulin delivery with an accessible portfolio of transformational devices, applications and services that reduce the daily burden of living with diabetes.

In support of this strategy, our portfolio of future technologies includes enhancing the features and capabilities of our t:slim X2 and Tandem Mobi insulin pump platforms, including adding a tubeless infusion site option for Tandem Mobi users.

Our development efforts also include Sigi, our ergonomic and rechargeable patch pump, in addition to extended wear infusion technology and algorithm advancement in pursuit of offering fully closed loop technology.

Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs, personal preferences and affordability.

Our strategy is to redefine global leadership in insulin delivery solutions through commercial excellence, patient-first reimbursement choices, and a differentiated device portfolio.

We strive to offer all people with insulin-dependent diabetes flexibility and choice in their intelligent insulin delivery systems, through our portfolio of market-leading pumps, applications, and insights that improve outcomes and reduce the daily burden of living with diabetes.

In support of this strategy, we continue to drive innovation in our Tandem pump platforms.

This includes a novel, extended-wear infusion site option for Mobi that will transform the pump into a tubeless patch device.

In addition, our pipeline also includes a next-generation Mobi patch pump that leverages the technology acquired with the Sigi Patch Pump to deliver further miniaturization.

Our development efforts also include extended-wear infusion set technology, dual glucose-ketone sensor integration, and algorithm advancement in pursuit of offering fully closed loop technology.

Markets and Distribution Methods

Our technology solutions are now available in the following 25 countries:

United Kingdom

Czech Republic

United States

In the United States and Canada, we employ direct sales, customer support, and clinical teams.

We also partner with independent distributors for order fulfillment.

Outside the United States and Canada, we contract with distributors who have substantial responsibility for sales, customer support, clinical efforts and order fulfillment.

In addition, we anticipate initiating direct sales, training and customer support activities in select European countries beginning in 2026.

Revenue Concentrations and Significant Customers.

Our technology solutions are now available in more than 25 countries.

In the United States and Canada, we have always employed direct sales, customer support, and clinical teams, partnering with independent distributors for order fulfillment.

Internationally, we have historically contracted with distributors who have substantial responsibility for sales, customer support, clinical efforts and order fulfillment.

We began direct sales, training and customer support activities in 2026, starting with the United Kingdom, Austria, and Switzerland, and intend to continue this transition in additional markets across 2026.

Sales Concentrations and Significant Customers.

A small number of independent distributors in the United States and Canada are responsible for order fulfillment.

We believe these distributors carry minimal inventory at any given time.

Outside the United States and Canada, there may be variability in inventory levels among our distributors, particularly when they first begin product sales or in the quarters surrounding the launch of new products.

In other markets, there may be variability in inventory levels among our distributors, particularly when we begin the transition to our own direct operations or in periods surrounding the launch of new products.

For the year ended December 31, 2025, two independent distributors each accounted for more than 10% of our worldwide sales.

Third-Party Reimbursement

In the United States, customer orders are typically fulfilled by billing third-party payors on behalf of our customers, or by using our network of distributors who then bill third-party payors on our customers’ behalf.

Typically, customers are eligible for insurance reimbursement for the purchase of a new insulin pump once every four years.

However, some plans may be limited to once every five years or have additional restrictions or requirements.

Insurance reimbursement processes outside the United States vary by geography.

We are accredited by the Community Health Accreditation Program and are an approved Medicare provider.

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.

A third-party payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved.

Further, coverage policies and third-party reimbursement rates may change at any time.

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.

In the United States, we are pursuing a multi-channel coverage and reimbursement strategy, enhancing coverage and reimbursement through both the durable medical equipment (DME) and pharmacy channels.

We believe this strategy will improve access and optimize the potential for better medical outcomes for people living with diabetes, while reducing the overall economic burden of diabetes care.

This also provides our customers with flexibility in how they use their insurance benefits to simplify onboarding and provide them with the most advantageous reimbursement terms.

Our increasing use of the pharmacy channel is discussed in this Annual Report under Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Internationally, insurance reimbursement processes vary by geography.

In markets where we have direct operations, we are responsible for all reimbursement, tender application and fulfillment activities.

Otherwise, that responsibility lies with our distributors.

Manufacturing and Quality Assurance

Our t:slim X2 pumps, Tandem Mobi pumps and Tandem Mobi cartridges are currently assembled, tested, and packaged at our facilities in San Diego, California.

Our insulin pumps are currently assembled, tested, and packaged at our facilities in San Diego, California.

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.

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.

Our Mobi cartridges have primarily been manufactured at our facilities in San Diego since launch, but we are in the process of transferring those operations to the same contract manufacturer who makes our t:slim X2 cartridges.

Outside suppliers are the source for raw materials, select components and some sub-assemblies used in the production of our insulin pumps and cartridges.

We purchase some supplies from a single or limited number of sources because of their proprietary know-how, quality assurance, cost-effectiveness, or constraints due to regulatory requirements.

For example, 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.

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.

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.

We purchase our raw materials and select components used in the manufacturing of our products from external suppliers.

We purchase some supplies from a single or limited number of sources for reasons of proprietary know-how, quality assurance, cost-effectiveness, or constraints resulting from regulatory requirements.

We work closely with our suppliers to help ensure continuity of supply while maintaining high quality and reliability.

However, due to required medical device manufacturing qualification requirements, we may not be able to quickly establish additional or replacement sources.

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.

We purchase many of our components and sub-assemblies from manufacturers with whom we are at least dual sourced and across various geographies.

We work closely with all suppliers to ensure continuity of supply while maintaining high quality and reliability.

Certain suppliers are evaluated, approved and monitored periodically by our quality department to ensure conformity with the specifications, policies and procedures applicable to our devices.

Members of our quality department also inspect a sample of devices at various steps during the manufacturing cycle to facilitate compliance with our devices’ stringent specifications.

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.

We have received certification from BSI Group, a Notified Body to the International Standards Organization (ISO), of our quality system.

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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.

We also work closely with our suppliers to ensure continuity of supply while maintaining high quality and reliability.

However, due to required medical device manufacturing qualification requirements, we may not be able to quickly establish additional or replacement sources.

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.

We purchase many of our components and sub-assemblies from manufacturers with whom we are at least dual sourced and across various geographies.

Intellectual Property

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We rely on a combination of copyright, patent, trademark, trade secret and other intellectual property laws, non-disclosure agreements and other measures to protect our proprietary rights.

As of December 31, 2024, our patent portfolio includes numerous issued patents and pending patent applications in the United States and other countries, which in the aggregate, we believe to be important to our business.

As of December 31, 2025, our patent portfolio included numerous issued patents and pending patent applications in the United States and other countries, which in the aggregate, we believe to be important to our business.

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.

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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.

Our patents and patent applications seek to protect aspects of key features of our pumps, cartridges, algorithms and pump systems.

Our patents and patent applications seek to protect aspects of key features of our pumps, cartridges, algorithms, infusion sets and pump systems.

We believe that our patent position provides us with sufficient rights to protect our current and proposed commercial products.

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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 markets worldwide with companies that manufacture insulin delivery devices, primarily Insulet, Medtronic, Ypsomed and Beta Bionics.

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 United States market and outside the United States, 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.

We compete in markets worldwide with companies that manufacture insulin delivery devices, primarily Beta Bionics, Insulet, Medtronic, mylife (formerly Ypsomed) and Sequel.

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 markets where we operate.

In addition, we face competition from a number of companies, medical researchers and existing pharmaceutical companies that are pursuing new delivery devices, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and prevention of diabetes.

Government Regulation

The medical devices that we manufacture are subject to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies.

These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of medical devices.

Devices are generally subject to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.

In addition, healthcare regulatory bodies in the United States and around the world impose a range of requirements related to the payment for medical devices and the procedures in which they are used, including laws intended to prevent fraud, waste, and abuse of healthcare dollars.

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.

Each new or significantly modified medical device we seek to commercially distribute in the United States will require either a pre-market notification under Section 510(k) of the U.S.

Our products are medical devices subject to extensive and ongoing regulation by the FDA and other federal and state regulatory authorities.

The FDA’s regulations govern product design and development, pre-clinical and clinical testing, pre-market clearance, authorization or approval, establishment registration and product listing, product manufacturing, product labeling, product storage, advertising and promotion, product sales, distribution, recalls and field actions, servicing and post-market clinical surveillance.

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 U.S.

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.

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 .

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

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

A 510(k) application must be supported by extensive data, including technical information, labeling, human factors data and potentially clinical data to meet any Special Controls.

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

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

There are three Class II categories classified by the FDA for the interoperability of devices as a complete AID system that are intended to help support continued rapid innovation by streamlining the regulatory pathway for integrated products approved by the FDA.

In June 2018, our t:slim X2 was the first insulin pump designated by the FDA as compatible with integrated continuous glucose monitoring (iCGM) devices.

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).

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.

In November 2023, our Control-IQ technology was cleared with additional features for people with type 1 diabetes age 2 and older.

Both the 510(k) clearance and PMA processes can be lengthy and expensive.

We have obtained 510(k) clearance on multiple devices in both Class II and Class III, including our Control IQ technology, the t:slim X2 and Tandem Mobi.

In addition, we may be required to obtain a new 510(k) clearance or PMA for significant post-market modifications to our products.

There are three types of interoperable FDA Class II devices (integrated continuous glucose monitoring systems (iCGMs), Alternate Controller Enabled (ACE) insulin pumps, and interoperable automated glycemic controllers (iAGC)) in a complete AID system.

The classification of these three device types into Class II is intended to help support continued rapid innovation by streamlining the FDA regulatory pathway for integrated CGM and insulin pumps with advanced algorithms.

Our pumps are classified as ACE pumps that are compatible with iCGM devices, and our Control-IQ and Control-IQ+ technologies are classified as an iAGC for people living with type 1 diabetes ages 2 and older.

In March 2025, our Control-IQ+ technology was cleared for people living with type 2 diabetes ages 18 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.

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.

Clinical trials are typically required to support a PMA application and are sometimes required for 510(k) clearance.

We anticipate that most of our future AID offerings will require supporting clinical data, either from clinical trials or potentially from evidence that we are able to collect through real-world use of our products.

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• establishment registration and device listing;

• QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

• quality management system regulations (QMSR), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

• labeling regulations that prohibit the promotion of products for uncleared, unapproved or “off-label” uses, and impose other restrictions on labeling, advertising and promotion;

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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.

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.

We are currently conducting a post-market surveillance study for Control-IQ+ technology for users 2-5 years of age.

We may elect to pursue additional post-market surveillance studies in the future.

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Inspections may include the manufacturing facilities of our subcontractors.

In the United States, several states require that durable medical equipment (DME) providers be licensed to sell products to patients in that state.

If the FDA believes 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.

Any such action by the FDA would have a material adverse effect on our business.

We may be unable to comply with all applicable FDA regulations.

To sell our products through the durable medical equipment (DME) channel in the United States, several states require that DME providers be licensed to sell products to patients in that state.

Some of these states require that DME providers maintain an in-state location or retain a licensed pharmacist, and in those states, we sell our products through a third-party distributor.

Additionally, to sell our products through the pharmacy channel in the United States, we are required to work with intermediaries who have the appropriate pharmacy licenses.

Tandem is also registered throughout the United States to issue payment plans.

Although we believe we are in material compliance with applicable state regulations regarding licensure requirements, if we were found to be noncompliant, we could be subject to fines and penalties or lose our licensure in that state, which could prohibit us from selling our current or future products to patients in that state.

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Although we believe that these arrangements do not violate the Anti-Kickback Statute, regulatory authorities may determine otherwise, especially as enforcement of this law historically has been a high priority for the federal government.

Noncompliance with the federal Anti-Kickback Statute could result in our exclusion from Medicare, Medicaid or other governmental programs (which could adversely affect our revenues to a material extent), restrictions on our ability to operate in certain jurisdictions, and civil and criminal penalties.

Noncompliance with the federal Anti-Kickback Statute could result in our exclusion from Medicare, Medicaid or other governmental programs (which could adversely affect our sales to a material extent), restrictions on our ability to operate in certain jurisdictions, and civil and criminal penalties.

Physician Self-Referral Law .

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Nevertheless, a determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in these jurisdictions.

Data Privacy and Information Security Laws and Regulations.

Our use of t:connect and Tandem Source data is subject to internal policies and procedures that are designed to comply with the federal United States Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as applicable United States 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.

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.

and United Kingdom (U.K.) General Data Protection Regulation, collectively known as GDPR, and similar E.U.

member state laws.

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.

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.

Health Insurance Portability and Accountability Act of 1996 (HIPAA).

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, HIPAA) mandated the adoption of standards for the exchange of electronic health information to encourage overall administrative simplification and enhance the effectiveness and efficiency of the healthcare industry.

Ensuring privacy and security of patient information is one of the key factors driving the legislation.

If we are found to violate HIPAA, we could be subject to civil or criminal penalties.

HIPAA and Other U.S.

Privacy Laws and Regulations .

Numerous federal and state laws, rules and regulations govern the collection, dissemination, use, privacy, security and confidentiality of personal information.

HIPAA, in addition to the criminal powers above, extensively regulates the use and disclosure of individually identifiable health information, through the Privacy, Security, and Breach Notification Rules.

HIPAA requires covered entities, including health plans and most health care providers, to implement administrative, physical and technical safeguards to protect the privacy and security of covered information (known as “protected health information”) and sets limits and conditions on the uses and disclosures that may be made of such protected health information.

HIPAA’s Security Rule and certain provisions of the HIPAA Privacy Rule and Breach Notification Rule apply to business associates of covered entities (i.e., entities that provide services to covered entities that may require access and use of protected health information on behalf of covered entities), and business associates are subject to direct liability for violation of these rules.

Covered entities must report breaches of unsecured protected health information to affected individuals without unreasonable delay and notification must also be made to the U.S.

Department of Health & Human Services, Office for Civil Rights (OCR) and, in certain situations involving large breaches, to the media.

The OCR enforces the HIPAA Rules and performs compliance audits and investigations.

In addition to enforcement by OCR, HIPAA authorizes state attorneys general to bring civil actions seeking either injunction or damages in response to HIPAA violations that impact state residents.

On December 1, 2022, OCR issued a bulletin on the requirements under HIPAA for online tracking technologies (e.g., cookies, pixels) to protect the privacy and security of health information.

This bulletin outlined OCR’s position on the use of online tracking technology vendors, when certain information received by such vendors constitutes protected health information under HIPAA, and accordingly, when business associate agreements must be executed between covered entities, like us, and such vendors.

We are a covered entity under HIPAA and in certain circumstances, we may also be a business associate of another covered entity or of another business associate.

There are numerous other laws, regulations and legislative and regulatory initiatives at the federal and state levels addressing privacy and security of personal information.

We also remain subject to federal and state privacy-related laws that may be more restrictive or contain different requirements than the privacy regulations issued under HIPAA.

These laws vary and could impose additional penalties.

Further, certain U.S.

states have proposed or enacted comprehensive consumer privacy laws and/or laws governing personal health information, such as the California Consumer Privacy Act, or CCPA.

Among other things, these state-specific laws create new data privacy obligations for covered companies and provide new privacy rights to state residents, including the right to opt out of certain disclosures of their information.

They may also cause us to incur substantial costs and expenses to ensure ongoing compliance.

state laws and regulations may also require us to notify affected individuals and state agencies in the event of a data breach involving individually identifiable information.

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation passed, as the increased cyber-attacks during recent international conflicts have once again put a spotlight on data privacy and security in the U.S.

and other jurisdictions.

We cannot predict where new legislation might arise, the scope of such legislation, or the potential impact to our business and operations.

Healthcare Fraud .

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A violation of this statute is a felony and may result in fines or imprisonment.

We believe we are in substantial compliance with these provisions of HIPAA.

Physician Payments Sunshine Act .

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Failure to submit the required data in an accurate and timely manner may result in the imposition of civil monetary penalties.

We believe we are in substantial compliance with the Physician Payments Sunshine Act to date.

Anti-Bribery and Anti-Corruption Laws.

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The scope of the FCPA would include interactions with certain healthcare professionals and hospital administrators in many countries.

We believe we are in substantial compliance with the FCPA and similar foreign regulations.

International Regulation

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There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.

Regulation of Medical Devices in the European Economic Area

On May 26, 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.

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.

Medical devices must comply with the General Safety and Performance Requirements, or GSPRs, set out in Annex I of the Medical Device Regulation.

The regulatory framework governing medical devices is largely harmonized within the European Union (EU), 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 EU with respect to medical devices.

In the EU, medical devices are governed by Regulation (EU) 2017/745 on medical devices (MDR), which entered into application on May 26, 2021, repealing and replacing both Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EEC concerning active implantable medical devices (AIMDD).

The MDR and its associated guidance documents and harmonized standards regulating the design, development, preclinical and clinical performance premarket conformity assessment, registration, manufacture, labeling storage, claims, sales and distribution, export and import and post-market surveillance, vigilance, and market surveillance for medical devices.

To be placed on the EU market, devices must undergo a conformity assessment and bear the CE mark, indicating that the device conforms to the requirements of the MDR.

In particular, medical devices must comply with the General Safety and Performance Requirements (GSPRs), set out in Annex I of the MDR.

Compliance with these requirements is a prerequisite to affixing 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).

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 conduct a conformity assessment procedure, which varies according to the type of medical device and its classification.

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 review by a Notified Body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments.

To demonstrate compliance with the GSPRs and obtain the right to affix the CE mark, medical devices manufacturers must conduct a conformity assessment procedure, which varies according to the type of medical device and its classification.

Apart from low-risk medical devices (Class I with no measuring function and which are not sterile), a conformity assessment procedure requires review by a Notified Body.

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.

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This Certificate and completion of 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.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the GSPRs must include the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.

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 safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence.

This assessment must be based on clinical data, which can be obtained from (1) clinical investigations 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 investigations and scientific literature.

The conduct of clinical studies in the EEA is governed by detailed regulatory obligations.

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.

This process can be expensive and time-consuming.

Moreover, after a device is placed on the market, it remains subject to significant regulatory requirements that must commonly be fulfilled by the manufacturer or on their behalf.

The Medical Device Regulation provides transitional provisions, amended by Regulation (EU) 2023/603.

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 May 26, 2021 and have not since been withdrawn will, with certain exceptions, remain valid until December 31, 2027 for Class III and Class IIb implantable medical devices and until December 31, 2028 for other Class IIb, Class IIa and Class I devices with a measuring function or which are sterile.

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 May 26, 2021, can continue to be placed on the EEA market until December 31,2028.

Manufacturers of medical devices may only benefit from the above extended transitional provisions deadlines if the following conditions are fulfilled:

(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 May 26, 2024 which complies with the requirements of the Medical Devices Regulation, (v) by May 26, 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 September 26, 2024, and (vi) from May 26, 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.

In addition, CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD from May 25, 2017, which were valid on May 26, 2021 and have not been withdraw since but which expired before March 20, 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.

Class III custom-made implantable medical devices may be placed on the market until May 26, 2026 without a CE Certificate of Conformity issued by Notified Body, provided that (i) by May 26,2024, 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 September 26, 2024.

The advertising and promotion of medical devices in the EEA 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 govern the advertisement and promotion of medical devices.

The national legislation of any individual EEA countries may also restrict or impose limitations on our ability to advertise our products directly to the general public.

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.

Outside of the European Union, regulatory approval would need to be sought on a country-by-country basis for us to market our products.

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.

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.

Moreover, 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 EEA countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.

These laws include the U.K.

Bribery Act and similar anti-bribery laws in other jurisdictions in which we operate.

Such laws generally prohibit United States-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.

In Great Britain (i.e.

England, Wales, and Scotland), medical devices are governed by the Medical Device Regulations (UK MDR) 2002, as amended.

In light of the fact that the CE Marking process discussed above is set out in EU law, which no longer applies in the United Kingdom (other than in Northern Ireland), the United Kingdom has devised a new route to market culminating in a UKCA Mark to replace the CE Mark.

The UK Government has established transitional provisions to recognize the acceptance of CE marked medical devices on the Great Britain market.

The MDR provides transitional provisions which, under strict conditions, permit manufacturers to continue to place medical devices on the market on the basis of CE Certificates of Conformity issued by Notified Bodies in accordance with the MDD or the AIMD until December 31, 2027 or December 31, 2028 depending on the risk classification.

Outside of the EU, regulatory approval needs to be sought on a country-by-country basis for us to market our products.

Other countries have adopted medical device regulatory regimes, such as Health Canada’s risk classification system for invasive devices, among others.

Each country may have its own processes and requirements for medical device licensing, approval, and regulation, therefore requiring us to seek regulatory approvals on a country-by country basis.

Internationally, a range of anti-bribery and anti-corruption laws, as well as some industry-specific laws and codes of conduct, apply to the medical device industry and interactions with government officials and entities and healthcare professionals.

Further, the EU member countries have emphasized a greater focus on healthcare fraud and abuse and have indicated greater attention to the industry by the European Anti-Fraud Office.

The Code of Ethical Business Practices became effective on January 1, 2017.

Increasingly stringent data protection and privacy rules have had and will continue to have substantial impact on the use of patient data across the healthcare industry.

The European Union’s General Data Protection Regulation (EU GDPR) and the United Kingdom’s General Data Protection Regulation (UK GDPR) (collectively, GDPR) applies across the EU and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for noncompliance.

Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities.

Due to the strong consumer protection aspects of GDPR, companies subject to its purview are allocating substantial legal costs to the development of necessary policies and procedures and overall compliance efforts.

Data transfer risk remains a potential issue that requires regular monitoring.

Certain governments around the world are also adopting laws and regulations pertaining to mandatory corporate sustainability reporting.

Environment, Social and Governance

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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.

In 2021, we began conducting employee engagement surveys through Gallup, a leading global consulting firm on employee engagement.

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.

In addition, we exceeded overall engagement in the professional, scientific and technical 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.

We focus on cultivating and encouraging an inclusive and equitable culture where diversity of thought is represented and can thrive throughout our organization.

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• Annual increases and incentive compensation are based on Company performance as well as each individual’s contribution to the Company’s achieved results and are documented through our talent management procedures as part of our annual review process.

To foster a stronger sense of ownership and align the interests of partners with stockholders, equity awards are provided to a substantial proportion of our employees under our broad-based stock incentive programs.

To foster a stronger sense of ownership and align the interests of partners with stockholders, equity awards are provided to a portion of our employees in line with benchmark practices under our broad-based stock incentive programs.

Also, our full-time U.S.

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What changed 10-K

Item 1. Business