What changed in this filing

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Item 1. Business

2025-02-18 compared with 2024-02-08 · 129 added, 134 removed, 550 unchanged (32% of the section changed)

ITEM 1 - BUSINESS

We are a medical device company primarily focused on the design, development and commercialization of continuous glucose monitoring, or CGM, systems for the management of diabetes by patients, caregivers, and clinicians around the world.

We are a medical device company primarily focused on the design, development and commercialization of continuous glucose monitoring, or CGM, systems for the management of diabetes and metabolic health by patients, caregivers, and clinicians around the world.

We received approval from the Food and Drug Administration, or FDA, and commercialized our first product in 2006.

We launched our latest generation systems, the Dexcom G6 ® integrated Continuous Glucose Monitoring System, or G6, in 2018 and more recently received marketing clearance from the FDA on the Dexcom G7 ® , or G7, in December 2022.

We launched our latest generation systems, the Dexcom G6 integrated Continuous Glucose Monitoring System, or G6, in 2018, and we launched the Dexcom G7, or G7, in 2023.

In August 2024, we launched Stelo, our new biosensor designed for adults with prediabetes and Type 2 diabetes who do not use insulin, as the first over-the-counter glucose biosensor in the U.S.

Unless the context requires otherwise, the terms “we,” “us,” “our,” the “company,” or “Dexcom” refer to DexCom, Inc.

and its subsidiaries.

In March 2018, we obtained marketing authorization from the FDA for the G6 via the de novo process.

The G6 was the first type of CGM system permitted by the FDA to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin delivery systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.

G6 and substantially equivalent devices of this generic type that may later receive marketing authorization are referred to as integrated continuous glucose monitoring systems, or iCGMs, and have been classified as Class II devices by the FDA.

Along with this classification, the FDA established criteria, called special controls, which outline requirements for assuring CGM accuracy, reliability and clinical relevance, and which also describe the type of studies and data required to demonstrate acceptable CGM performance.

The G6 is designed to allow our transmitter to run an algorithm to generate a glucose value and to communicate directly to a patient’s compatible mobile device, including iPhone ® , iPod touch ® , iPad ® , and certain Android ® mobile devices.

A patient’s glucose data can also be displayed on wearable devices, like the Apple Watch ® and Wear OS by Google devices.

The G6 transmitter has a labeled useful life of three months.

Data from the G6 can be integrated with Dexcom CLARITY ® , our cloud-based reporting software, for personalized, easy-to-understand analysis of trends that may improve diabetes management.

In the United States, the G6 is covered by Medicare and Medicaid in the majority of states and by commercial insurers, subject to satisfaction of certain eligibility and coverage criteria for individuals with both Type 1 and Type 2 diabetes.

In June 2018, we received Conformité Européenne Marking, or CE Mark, approval for the G6, which allows us to market the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark, as well as New Zealand, though certain countries may require compliance with certain local administrative requirements and/or additional marketing authorizations (for example, the inclusion of medical devices on the Australian Register of Therapeutic Goods in Australia).

In October 2019, we also received marketing authorization from the FDA for the Dexcom G6 Pro, or G6 Pro, which allows healthcare professionals to purchase the G6 for use with their patients.

The G6 Pro has many of same features as the G6 and is intended for healthcare professionals to use with their patients ages two years and up.

The G6 Pro may be used in a blinded or unblinded mode for up to 10 days.

For the G6, the sensor is inserted by the user and is intended to be used continuously for up to 10 days, after which it may be replaced with a new disposable sensor.

Our transmitter is reusable until it reaches the end of its use life, labeled as three months.

Our receiver is also reusable.

As we continue to establish an installed base of customers using our products, we expect to generate an increasing portion of our revenues through recurring sales of our disposable sensors.

The G6 carries forward important features of prior generation Dexcom CGM systems:

• Continuous glucose readings.

Automatically sends glucose readings to a Dexcom receiver or compatible display device every five minutes.

• Mobile app and sharing.

Compatibility with mobile device applications allows for sharing glucose information with up to 10 other people for added support and care coordination.

• Integration with the world’s largest connected CGM ecosystem (including Apple Watch, Garmin and other digital health apps).

• Customizable alarms and alerts.

Personalized alert schedule immediately warns the user of pending dangerous high and low blood sugar levels.

The G6 also has a number of new or improved features compared to our prior generation devices:

• Finger stick elimination.

No finger sticks are needed for calibration or diabetes treatment decisions, consistent with the instructions for use, unless symptoms do not match readings.

• Easy sensor application.

Complete redesign of the sensor applicator allows for one-touch, simple self-insertion.

• Discreet and low profile.

A redesigned transmitter with a 28% lower profile than the previous generation Dexcom CGM system makes the device comfortable and easy to wear under clothing.

• Medication blocking.

Allows for more accurate glucose readings without interference from common medications taken at typical indication doses, such as acetaminophen.

• Predictive low alert.

Alert feature intended to predict hypoglycemia before it hits to help avoid dangerous low blood sugar events.

• Extended 10-day disposable sensor.

Up to 10-day sensor use allows for 43% longer wear than previous generation Dexcom CGM systems.

Other than the foregoing, the features of the G6 are generally consistent with our prior generation CGM systems in its technical capabilities and its indications.

Since the G6 is classified by the FDA as a Class II device, it is subject to special controls and modifications of, or revisions to, the device may be made under the 510(k) process.

In March 2022, we obtained CE Mark approval for G7.

In March 2022, we obtained Conformité Européenne Marking, or CE Mark, approval for G7.

In December 2022, we obtained marketing authorization from the FDA for the G7 via the 510(k) review process.

Like the G6, the G7 is an iCGM, is classified as a Class II device by the FDA, and is subject to special controls.

The glucose value algorithm, ability to communicate with approved display and mobile devices, and compatibility with CLARITY ® are all substantially equivalent in technical performance and capability to the G6.

Like the G6, the G7 is an integrated continuous glucose monitoring system, or iCGM, and is classified as a Class II device by the FDA, and is subject to special controls.

The glucose value algorithm, ability to communicate with approved display and mobile devices, and compatibility with Dexcom Clarity, our cloud-based reporting software, are all substantially equivalent in technical performance and capability to the G6.

In the United States, the G7 is covered by Medicare and Medicaid in the majority of states and by commercial insurers, subject to satisfaction of certain eligibility and coverage criteria for individuals with both Type 1 and Type 2 diabetes.

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Since the G7 is classified by the FDA as a Class II device, it is subject to special controls and modifications of, or revisions to, the device may be made under the 510(k) process.

Dexcom Stelo ®

We are pursuing regulatory approvals for Dexcom Stelo, our first product designed specifically for people with type 2 diabetes who do not use insulin and are not at risk for hypoglycemia.

Stelo was submitted for FDA review in the fourth quarter of 2023.

Dexcom Share ®

The Dexcom Share remote monitoring system, offered for use with any current Dexcom system, uses an app on the patient’s compatible iPhone, iPod touch, iPad or Android mobile device to securely and wirelessly transmit glucose information to the cloud and then to apps on the mobile devices of up to five designated recipients, or “followers,” who can remotely monitor a patient’s glucose information and receive alert notifications anywhere they have a wireless connection.

A patient’s glucose data can also be displayed on a patient’s or follower’s wearable device, such as the Apple Watch and Wear OS by Google devices, when used in conjunction with the patient’s or follower’s compatible iPhone or Android mobile device.

Dexcom Real-Time API

In July 2021, we received FDA marketing clearance for an iCGM system incorporating our Real-Time Application Programming Interfaces (API), which is an added software component that expands connectivity and interoperability of the Dexcom CGM digital ecosystem, enabling communication of iCGM data to client software intended to receive data through the cloud.

Dexcom Real-Time API enables authorized third-party software developers to integrate real-time CGM data into their digital health apps and devices for specific and permitted use cases including non-medical device application, medical device data analysis, iCGM secondary display alarm, active patient monitoring, and treatment decisions.

Real-Time API is not permitted for use in environments not currently cleared for the Dexcom CGM System (e.g., hospital inpatient care), and is not intended to be used by automated insulin delivery systems.

In March 2018, we obtained marketing authorization from the FDA for the G6 via the de novo process.

The G6 is designed to automatically transfer data from the transmitter to the Dexcom receiver device as well as allow our transmitter to run an algorithm to generate a glucose value and to communicate directly to a patient’s compatible mobile device, including iPhone ® , iPod touch ® , iPad ® , and certain Android ® mobile devices.

A patient’s glucose data can also be displayed on wearable devices, like the Apple Watch ® and Wear OS by Google devices.

The G6 transmitter has a labeled useful life of three months.

Data from the G6 can be integrated with Dexcom Clarity, our cloud-based reporting software, for personalized, easy-to-understand analysis of trends that may improve diabetes management.

In June 2018, we received CE Mark approval for the G6, which allows us to market the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark, as well as New Zealand, though certain countries may require compliance with certain local administrative requirements and/or additional marketing authorizations (for example, the inclusion of medical devices on the Australian Register of Therapeutic Goods in Australia).

In October 2019, we also received marketing authorization from the FDA for the Dexcom G6 Pro, or G6 Pro, which allows healthcare professionals to purchase the G6 for use by their patients.

The G6 Pro has many of same features as the G6 and is intended for healthcare professionals to use with their patients ages two years and up.

The G6 Pro may be used in a blinded or unblinded mode for up to 10 days.

For the G6, the sensor is inserted by the user and is intended to be used continuously for up to 10 days, after which it may be replaced with a new disposable sensor.

Our transmitter is reusable until it reaches the end of its use life, labeled as three months.

Our receiver is also reusable.

As we continue to establish an installed base of customers using our products, we expect to generate an increasing portion of our revenues through recurring sales of our disposable sensors.

The G6 carries forward important features of prior generation Dexcom CGM systems:

• Continuous glucose readings.

Automatically sends glucose readings to a Dexcom receiver or compatible display device every five minutes.

• Mobile app and sharing.

Compatibility with mobile device applications allows for sharing glucose information with up to 10 other people for added support and care coordination.

• Integration with the world’s largest connected CGM ecosystem (including Apple Watch, Garmin and other digital health apps).

• Customizable alarms and alerts.

Personalized alert schedule immediately warns the user of pending dangerous high and low blood sugar levels.

The G6 also has a number of new or improved features compared to our prior generation devices:

• Finger stick elimination.

No finger sticks are needed for calibration or diabetes treatment decisions, consistent with the instructions for use, unless symptoms do not match readings.

• Easy sensor application.

Complete redesign of the sensor applicator allows for one-touch, simple self-insertion.

• Discreet and low profile.

A redesigned transmitter with a 28% lower profile than the previous generation Dexcom CGM system makes the device comfortable and easy to wear under clothing.

• Medication blocking.

Allows for more accurate glucose readings without interference from common medications taken at typical indication doses, such as acetaminophen.

• Predictive low alert.

Alert feature intended to predict hypoglycemia before it hits to help avoid dangerous low blood sugar events.

• Extended 10-day disposable sensor.

Up to 10-day sensor use allows for 43% longer wear than previous generation Dexcom CGM systems.

Other than the foregoing, the features of the G6 are generally consistent with our prior generation CGM systems in its technical capabilities and its indications.

Since the G6 is classified by the FDA as a Class II device, it is subject to special controls and modifications of, or revisions to, the device may be made under the 510(k) process.

In July 2021, we obtained CE Mark approval for our Dexcom ONE CGM system, or Dexcom ONE, which we have launched in several countries in Europe.

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This updated version of our Dexcom ONE system builds upon the software experience of Dexcom ONE with certain additional features, while allowing customers to adopt the all-in-one wearable technology of our G7 CGM system.

In August 2024, we launched Stelo, our new biosensor designed for adults with prediabetes and Type 2 diabetes who do not use insulin, as the first over-the-counter glucose biosensor in the U.S.

The Dexcom Share remote monitoring system, offered for use with any current Dexcom system, uses an app on the patient’s compatible iPhone, iPod touch, iPad or Android mobile device to securely and wirelessly transmit glucose information to the cloud and then to apps on the mobile devices of up to ten designated recipients, or “followers,” who can remotely monitor a patient’s glucose information and receive alert notifications anywhere they have a wireless connection.

Data and Insulin Delivery Collaborations

We have entered into multiple collaboration agreements that leverage our technology platform to integrate our CGM products with insulin delivery systems.

The general purpose of these development and commercial relationships is

to integrate our technology into the insulin pump or pen product offerings of the respective partner, enabling the partner’s insulin delivery device to receive and display glucose readings from our transmitter and, in some cases, use the glucose readings for semi-automated insulin delivery.

The general purpose of these development and commercial relationships is to integrate our technology into the insulin pump or pen product offerings of the respective partner, enabling the partner’s insulin delivery device to receive and display glucose readings from our transmitter and, in some cases, use the glucose readings for semi-automated insulin delivery.

We have existing insulin delivery partnerships, and we are also working with other companies that are pursuing varying strategies surrounding semi-automated insulin delivery and data analytics to improve outcomes and ease-of-use in diabetes management.

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Verily Collaboration

Our Restated Collaboration Agreement with Verily Life Science LLC (an Alphabet Company) and Verily Ireland Limited (collectively, Verily) provides us with an exclusive license to use intellectual property of Verily resulting from the collaboration, and certain Verily patents, in the development, manufacture and commercialization of blood-based or interstitial glucose monitoring products more generally (subject to certain exclusions, which are outside the CGM field as it is commonly understood).

It also provides us with non-exclusive license rights under Verily’s other intellectual property rights to develop, manufacture, and commercialize those kinds of glucose monitoring products and certain CGM product companion software functionalities.

In consideration of Verily’s performance of its obligations under the joint development plan of the Restated Collaboration Agreement, the licenses granted to us and the amendment of the original agreement, we have made upfront, incentive, product regulatory approval milestone payments, and a sales-based milestone payment.

In the future, we may make a potential additional milestone payment for a future sales-based milestone.

At our election, we may make these payments in shares of our common stock or cash.

If we elect to make a milestone payment in cash, any such cash payment would be equal to the number of shares that would otherwise be issued for the given milestone payment multiplied by the value of our stock on the date the relevant milestone is achieved, adjusted for stock splits, dividends, and the like.

We intend to pay the remaining sales-based contingent milestone in shares of our common stock.

In connection with the Restated Collaboration Agreement, we developed, launched and commercialized a CGM product in connection with the collaboration.

In consideration of Verily’s performance of its obligations under the joint development plan of the Restated Collaboration Agreement, the licenses granted to us and the amendment of the original agreement, we made upfront, incentive, and the product regulatory approval payments, and payments for contingent sales-based milestones upon the achievement of certain revenue targets.

See Note 2 “ Development and Other Agreements ” to the consolidated financial statements in Part II, Item 8 of this Annual Report and Exhibit 10.13 of this Annual Report on Form 10-K for a further description of the Restated Collaboration Agreement, including the number of shares of stock for milestone payments.

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This growing diabetes prevalence and its associated health outcomes also result in sobering economic burdens for global health systems.

According to the American Diabetes Association, or ADA, one in every four healthcare dollars

was spent on treating people with diabetes in 2022, and the direct medical costs and indirect expenditures attributable to diabetes in the United States were an estimated $413 billion, an inflation-adjusted increase of approximately 35% since 2012.

According to the American Diabetes Association, or ADA, one in every four healthcare dollars was spent on treating people with diabetes in 2022, and the direct medical costs and indirect expenditures attributable to diabetes in the United States were an estimated $413 billion, an inflation-adjusted increase of approximately 35% since 2012.

Of the $413 billion in overall expenses, the ADA estimated that approximately $307 billion were direct costs associated with diabetes care, chronic complications and excess general medical costs, and $106 billion were indirect costs.

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Several followers can remotely monitor a patient’s glucose information and receive secondary alert notifications from almost anywhere with an Internet connection via each follower’s mobile device.

Our objective is to remain a leading provider of CGM systems and related products to enable people with diabetes to more effectively and conveniently manage their condition.

Our objective is to remain a leading provider of glucose biosensors and related products to enable people with diabetes and those seeking to optimize metabolic health to more effectively and conveniently manage their glucose levels.

We are also developing and commercializing products that integrate our CGM technologies into the insulin delivery systems or data platforms of our respective partners.

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A receiver may be required as the primary display device or a backup to the mobile device in some jurisdictions, including the United States.

Dexcom Real-Time API

Products in Development

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We continue to pursue and support development partnerships with insulin pump companies and companies or institutions developing insulin delivery systems, including automated insulin delivery systems.

We are also exploring how to extend our offerings to other opportunities, including for people with Type 2 diabetes that are non-insulin using, people with pre-diabetes, people who are obese, people who are pregnant, and people in the hospital setting.

With the introduction of Stelo, we are also pursuing and supporting development partnerships with consumer technology product companies that seek to provide metabolic health insights to their customers.

We are also exploring how to extend our offerings to other opportunities, including for people with pre-diabetes, people who are obese, people who are pregnant, and people in the hospital setting.

Eventually, we may apply our technological expertise to products beyond glucose monitoring.

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We use a variety of marketing tools to drive adoption, ensure continued use and establish brand loyalty for our CGM systems by:

• creating awareness of the benefits of continuous glucose monitoring and the advantages of our technology with endocrinologists, physicians, diabetes educators and people with diabetes;

• creating awareness of the benefits of continuous glucose monitoring and the advantages of our technology with endocrinologists, physicians, diabetes educators, people with diabetes and those seeking to optimize metabolic health;

• providing strong and simple educational and training programs to healthcare providers and people with diabetes to ensure easy, safe and effective use of our systems;

• maintaining a readily accessible telephone and web-based technical and customer support infrastructure, which includes clinicians, diabetes educators and reimbursement specialists, to help referring physicians, diabetes educators and people with diabetes as necessary.

Direct-to-consumer (DTC) marketing is one of our key initiatives to increase awareness of our CGM systems and drive new leads for people with diabetes to our website.

Direct-to-consumer (DTC) marketing is one of our key initiatives to increase awareness of our CGM systems and drive new leads for people with diabetes and those seeking to optimize metabolic health to our website.

In jurisdictions where DTC marketing is permitted, we currently focus on reaching people with Type 1 and people with Type 2 diabetes who use insulin.

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and Ascensia Diabetes Care, each of which manufactures and markets products for the single-point finger stick device market.

Collectively, these companies currently account for the majority of the worldwide sales of self-monitored glucose testing systems.

Collectively with us, these companies currently account for the majority of the worldwide sales of self-monitored glucose testing systems.

Several companies are developing or commercializing products for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin that compete directly with our products.

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Medtronic and other third parties have developed or are developing, insulin pumps integrated with continuous glucose monitoring systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal or bolus insulin dosing.

Likewise, Abbott Diabetes Care has

received FDA clearance to integrate certain versions of their Libre sensors into automated insulin delivery systems and is pursuing such integrations with third-party insulin delivery devices.

Likewise, Abbott Diabetes Care has received FDA clearance to integrate certain versions of their Libre sensors into automated insulin delivery systems and is pursuing such integrations with third-party insulin delivery devices.

We are also aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for the general health and wellness, or population health space.

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• effective sales, marketing and distribution networks;

• brand awareness and strong acceptance by healthcare professionals and people with diabetes;

• customer service and support and comprehensive education for people with diabetes and diabetes care providers;

• brand awareness and strong acceptance by healthcare professionals, people with diabetes and those seeking to optimize metabolic health;

• customer service and support and comprehensive education for people with diabetes, diabetes care providers and those seeking to optimize metabolic health;

• speed of product innovation and time to market;

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We currently manufacture our products at our headquarters in San Diego, California and at our manufacturing facilities in Mesa, Arizona and Penang, Malaysia, where we collectively have approximately 80,600 square feet of laboratory space and approximately 159,600 square feet of controlled environment rooms.

In 2023, we completed the initial phase of construction of our new facility in Malaysia and commenced commercial manufacturing.

We are also expanding our facility in Mesa, Arizona to scale up manufacturing capacity and plan to begin construction of a new facility in Ireland.

We anticipate that the new facilities and the Mesa capacity scale-up will add substantial manufacturing capacity.

We are currently building out a new manufacturing facility in Athenry, Ireland.

We anticipate that the new facility will add substantial manufacturing capacity.

There are technical challenges to increasing manufacturing capacity, finding or enhancing new manufacturing facilities capable of meeting regulatory requirements, government licensure of manufacturing facilities, equipment design and automation, material procurement, problems with production yields, and quality control and assurance.

We have focused significant effort on continual improvement programs in our manufacturing operations intended to improve quality, yields and throughput.

We have made progress in manufacturing to enable us to supply adequate amounts of product to support our commercialization efforts, however we cannot guarantee that supply will not be constrained going forward.

Additionally, the production of our continuous glucose monitoring systems must occur in a highly controlled and clean environment to minimize particles and other yield- and quality-limiting contaminants.

While we have focused significant effort on continual improvement programs in our manufacturing operations intended to improve quality, yields and throughput, we cannot guarantee that we will be able to produce an adequate supply of product to support our commercialization efforts.

We have recently experienced manufacturing and inventory challenges for G7 that have resulted, and may continue to result from time to time, in disruptions in our ability to supply certain markets, including in the U.S.

While we are currently working to remedy such challenges, we cannot predict when such manufacturing and inventory challenges will be remedied.

If we fail to produce a sufficient amount of our products, our ability to supply our markets will be compromised and health care providers and people with diabetes’ decisions to use our products may be negatively impacted.

This could lead to loss of sales of and revenues from our products, could potentially decrease our market share, and/or our business, financial condition, results of operations and growth prospects could be materially adversely affected.

See the section of the Risk Factors entitled “ Risks Related to Manufacturing, Commercial Operations and Commercialization.

Additionally, the production of our continuous glucose monitoring systems must occur in a highly controlled and clean environment to minimize particles and other yield-limiting and quality-limiting contaminants.

Developing and maintaining commercial-scale manufacturing facilities has and will continue to require the investment of substantial additional funds and the hiring and retention of additional management, quality assurance, quality control and technical personnel who have the necessary manufacturing experience.

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Previously, Medicare coverage for CGM was only available to Medicare patients who take at least three doses of insulin a day, limiting CGM reimbursement for Medicare beneficiaries with intensive Type 1 and 2 diabetes.

The Local Coverage Determination, or LCD, that the Centers for Medicare & Medicaid Services released in April 2023 extends Medicare CGM coverage to all patients using insulin.

The Local Coverage Determination, or LCD, that the Centers for Medicare & Medicaid Services (CMS) released in April 2023 extends Medicare CGM coverage to all patients using insulin.

Further, the LCD also allows coverage for patients not taking insulin if the patient has a history of problematic hypoglycemia.

We also have coverage under certain international markets and Medicaid coverage in approximately 47 states.

As of December 31, 2023, the eight largest private third-party payors, in terms of the number of covered lives, have issued coverage policies for the category of continuous glucose monitoring devices.

As of December 31, 2024, the eight largest private third-party payors in the United States, in terms of the number of covered lives, have issued coverage policies for the category of continuous glucose monitoring devices.

In addition, we have negotiated contracted rates with all of those third-party payors for the purchase of our current CGM systems by their members.

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and other parts of the world, which, in the aggregate, we believe to be of material importance in the operation of our business.

patents, as well as most foreign patents, are generally effective for 20 years from the date the earliest application was filed.

patents, as well as most foreign patents, are generally effective for 20 years from the date the earliest application

In some cases, the patent term may be extended.

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We also generally require confidentiality or material transfer agreements from third parties that receive our confidential data or materials.

We cannot guarantee that employees and third parties will abide by the confidentiality

or assignment terms of these agreements.

We cannot guarantee that employees and third parties will abide by the confidentiality or assignment terms of these agreements.

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.

Sustainability

We believe that taking into account the interests of our various stakeholders – including patients, caregivers, employees, investors, and our communities – enables us to operate in a sustainable manner, supports the success of our business and drives long-term value.

We believe that taking into account the interests of our various stakeholders – including patients, caregivers, those seeking to optimize metabolic health, employees, investors, and our communities – enables us to operate in a sustainable manner, supports the success of our business and drives long-term value.

We do this by holding true to our core values:

Listen, Think Big, Be Dependable, and Serve with Integrity.

These values are at the heart of our sustainability initiatives.

• Listen – We believe in listening to our customers and our employees.

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We also maintain a compliance program to help enforce ethical conduct and adherence to applicable laws and regulations.

The Nominating and Governance Committee of the Board of Directors oversees and reviews Dexcom’s risks, opportunities, strategies, programs, policies, practices, measures, objectives and performance relating to corporate sustainability matters.

Our management-level Corporate Sustainability Steering Committee, which is comprised of the functional leads from our Commercial, Operations, Human Capital, Finance and Legal departments, is responsible for, among other things, setting the overall strategy with respect to corporate sustainability matters (subject to direction from the Chief Executive Officer and oversight of the Nominating and Governance Committee), establishing programs, policies and practices relating to corporate sustainability matters (“Dexcom’s Corporate Sustainability Program”) and overseeing and monitoring the implementation of Dexcom’s Corporate Sustainability Program.

The Corporate Sustainability Steering Committee reports to our Chief Executive Officer and provides periodic updates regarding our corporate sustainability programs, policies and practices to the Nominating and Governance Committee of our Board of Directors.

The Nominating and Governance Committee of the Board of Directors oversees and reviews Dexcom’s policies and programs concerning corporate social responsibility and Dexcom’s participation and visibility as a global corporate citizen.

In addition, the Nominating and Governance Committee oversees and reviews our sustainability performance and the assessment and management of environmental, sustainability and governance risks affecting our business.

term strategy, taking into consideration environmental, social and economic dimensions (subject to direction from the Chief Executive Officer and oversight of the Nominating and Governance Committee), establishing programs, policies and practices to integrate sustainability into Dexcom’s strategy, and assisting the Nominating and Governance Committee in fulfilling its oversight responsibilities with respect to Dexcom’s performance and behavior for sustainability matters.

Our Sustainability Report is available at https://investors.dexcom.com/governance/governance-documents, which is provided for reference only and is not incorporated by reference into this Annual Report on Form 10-K.

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If a previously unclassified new medical device does not qualify for the 510(k) pre-market notification process because no predicate device to which it is substantially equivalent can be identified, the device is automatically classified into Class III.

Under FDA law, the de novo classification procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA.

Under FDA law, the de novo classification procedure allows a manufacturer whose novel

device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA.

If the FDA agrees with the down-classification, the de novo applicant will then receive authorization to market the device, and a classification regulation will be established for the device type.

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A PMA application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.

In addition to our CGM device, we have a Class I data management service which we market to clinics.

In addition to our CGM devices, we have a Class I data management service which we market to clinics.

This service helps healthcare providers and patients see, understand and use blood glucose meter data to diagnose and manage diabetes.

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Anti-kickback Laws.

The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or providing remuneration directly or indirectly to induce either (i) the referral of an individual, or (ii) purchasing, ordering, recommending, or arranging for the purchase or order of a good or service, for which

payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid.

The definition of “remuneration” has been broadly interpreted to include anything of value, including such items as gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments to consultants, waiver of payments, and providing anything at less than its fair market value.

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Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action, even before the validity of the claim is established and even if the government decides not to intervene in the lawsuit.

Healthcare companies may decide to agree to large settlements with the government and/or whistleblowers to avoid the cost and negative publicity associated with litigation.

Federal enforcement agencies also have shown increased interest in pharmaceutical and medical device companies’ product promotion, health care professional engagements, and patient assistance programs, including reimbursement and co-pay support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements.

Healthcare companies may decide to agree to large settlements with the government and/or whistleblowers to avoid the cost, distraction and negative publicity associated with litigation.

into these programs have resulted in significant civil and criminal settlements.

In addition, the Affordable Care Act amended federal law to provide that the government may assert that a claim for items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Criminal prosecution is also possible for knowingly making or presenting a false or fictitious or fraudulent claim to the federal government.

Criminal prosecution is also possible under the Criminal False Claims Act for knowingly making or presenting a false or fictitious or fraudulent claim to the federal government.

Federal Physician Self-Referral Law.

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In doing so, we have limited our exposure under the Stark Law.

In addition to the Stark Law, many states have implemented similar physician self-referral prohibitions that may extend to Medicaid, third party payors, and self-pay patients, and may be applicable to our relationships with physicians and other health care providers.

In addition to the Stark Law, many states have implemented similar physician self-referral prohibitions that may extend to Medicaid, third party payors, and/or self-pay patients, and may be applicable to our relationships with physicians and other health care providers.

Civil Monetary Penalties Law .

The Civil Monetary Penalties Law, or CMPL, authorizes the imposition of substantial civil money penalties against an entity that engages in certain prohibited activities including but not limited to violations of the Stark Law or Anti-Kickback Statute, knowing submission of a false or fraudulent claim, employment of an individual excluded from participation in federal health care programs, and the provision or offer of anything of value to a Medicare or Medicaid beneficiary that the transferring party knows or should know is likely to influence the beneficiary’s selection of a particular provider or supplier from which to receive items or services for which payment may be made in whole or part by a federal health care program, commonly known as the Beneficiary

Inducement CMP.

Remuneration is defined under the CMPL as any transfer of items or services for free or for less than fair market value.

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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 information without the authorization of the relevant individual.

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.

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.

In addition, a covered entity may be subject to criminal and civil penalties as a result of a business associate violating HIPAA, if the business associate is found to be an agent of the covered entity.

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These laws vary and could impose additional penalties.

For example, the Federal Trade Commission, or FTC, uses its consumer protection authority to initiate enforcement actions against companies relating to their use and

disclosure of personally identifiable information.

For example, the Federal Trade Commission, or FTC, uses its consumer protection authority to initiate enforcement actions against companies relating to their use and disclosure of personally identifiable information.

Specifically, FTC has asserted authority and issued enforcement actions in response to actual or perceived unfair or deceptive practices by a company in the handling of consumer information.

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the Montana Consumer Data Privacy Act, effective as of October 1, 2024;

the Delaware Personal Data Privacy Act, effective as of January 1, 2025;

the Iowa Act Relating to Consumer Data Protection, effective as of January 1, 2025;

the Delaware Personal Data Privacy Act, the Nebraska Data Privacy Act, the New Hampshire Data Privacy Act, and the Iowa Act Relating to Consumer Data Protection, effective as of January 1, 2025;

the Tennessee Information Protection Act, effective as of July 1, 2025;

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The CCPA also created a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach, and other laws, such as the Telephone Consumer Privacy Act and the Washington My Health My Data Act, also have private rights of action for violations.

Regulations implementing the California and Colorado laws have been published (in draft form for California, and final form for Colorado), but many questions remain as to how all of the new statutes will be interpreted and enforced.

Regulations implementing the California and Colorado laws have been published, but many questions remain as to how all of the new statutes will be interpreted and enforced.

The effects of state data protection laws are significant and have required us to modify our data processing practices.

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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 in 2024 and beyond, as the increased cyber-attacks during recent international conflicts have once again put a spotlight on data privacy and security in the U.S.

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.

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These expanded reporting requirements took effect in 2022 for payments and transfers of value made to these additional practitioner-types in 2021.

CMS has the potential to impose penalties of up to $1.36 million per year for violations of the Physician Payment Sunshine Act, depending on the circumstances, and reported payments also have the potential to draw scrutiny to our relationships with health care practitioners and academic medical institutions, which may have implications under the Anti-Kickback Statute and other healthcare laws.

CMS has the potential to impose penalties of up to $1,406,728 per year (adjusted annually) for violations of the Physician Payment Sunshine Act, depending on the circumstances, and reported payments also have the potential to draw scrutiny to our relationships with health care practitioners and academic medical institutions, which may have implications under the Anti-Kickback Statute and other healthcare laws.

CMS has the right to audit reporting entities for compliance.

CMS began its first audits in fiscal year 2023.

In addition, certain states also have laws and regulations related to payments and other transfers of value provided to healthcare professionals and entities.

Similar to the federal law, certain states have adopted marketing and/or transparency laws relevant to device manufacturers, some of which are broader in scope.

Certain states also

mandate that device manufacturers implement compliance programs.

Certain states also mandate that device manufacturers implement compliance programs.

Other states impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation, and other remuneration to healthcare professionals and entities.

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International Regulation

International sales of medical devices are subject to foreign government regulations, which may vary substantially from country to country.

The time required to obtain approval in a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ.

International sales of medical devices are subject to international government regulations, which may vary substantially from country to country.

The time required to obtain approval in an international country may be longer or shorter than that required for FDA approval, and the requirements may differ.

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

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The MDR became applicable in the European Union on May 26, 2021, changing several aspects of the existing regulatory framework.

Other countries have adopted medical device regulatory regimes, such as the Classification Rules for Medical Devices published by the Hong Kong Department of Health, the Health Sciences Authority of Singapore regulation of medical devices under the Health Products Act, and Health Canada’s risk classification system for invasive devices, among others.

Other countries have adopted medical device regulatory regimes, such as the Classification Rules for Medical Devices published by the Hong Kong Department of Health, the Health Sciences Authority of

Singapore regulation of medical devices under the Health Products Act, and 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.

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Privacy Shield Framework invalid (Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems, also knowns as “Schrems II”).

In the absence of the new adequacy decision, this judgment still results in additional compliance obligations for companies that rely on mechanisms other than the Privacy Shield, like standard contractual clauses and appropriate supplementary measures to ensure a valid basis for the transfer of personal

data outside of Europe.

Though a new adequacy decision (the EU-U.S.

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We expect continued costs associated with maintaining compliance with the GDPR into the future, and these requirements, as interpreted by EU data protection authorities, could negatively impact our business, financial condition and results of operations.

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

For example, the European Union has adopted the Corporate Sustainability Reporting Directive (CSRD) that will require us to disclose certain social, governance and environmental information and data.

Environmental Regulation

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Since 2005, we have used experts in various disciplines on a consulting basis as needed to solve problems or accelerate development pathways.

We may continue to engage advisors from the academic, consultancy, governmental or other areas to assist us as necessary.

We may continue to engage advisors from the academic, consultancy, governmental or

other areas to assist us as necessary.

Relationships between manufacturers and physicians, including in consultancy and advisory board roles, is subject to scrutiny under the federal Anti-Kickback Statute and its state law equivalents.

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Human Capital

We aim to foster a diverse, inclusive and engaging culture that values each person’s unique skill set and to continue to attract – and retain – top talent throughout the organization.

2023 represented a year of growth across Dexcom;

We aim to foster an inclusive and engaging culture that values each person’s unique skill set and to continue to attract – and retain – top talent throughout the organization.

2024 represented a year of continued growth across Dexcom;

our employee population grew both by number and global footprint.

With our shift from office to hybrid work, we have access to more – and more diverse – talent than ever before.

Our consistent support of hybrid work provides access to a broader talent pool.

As of December 31, 2024, we have approximately 10,300 employees around the globe, including 10,200 full-time employees.

Approximately 64% of our full-time U.S.

employees are ethnically diverse.

Country Female Male Grand Total Ethnically Diverse

United States 2,400 2,900 5,300 3,100

International

2,100 1,700 3,800 N/A

International 2,700 2,300 5,000 N/A

Grand Total** 5,100 5,200 10,300 3,100

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**Includes full time and part time employees.

The human capital measures and objectives that we focus on include diversity, equity and inclusion (“DEI”);

The human capital measures and objectives that we focus on include equity and inclusion;

communications and engagement;

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and talent growth and development.

Diversity, Equity and Inclusion

Our journey to create a more diverse, equitable and inclusive workplace continues.

As Dexcom continues to grow and scale, we believe our DEI initiatives have been critical not only for company culture but also for the growing diversity of patients our products will benefit across the globe.

Our talent and diversity staff and the DEI Leadership Council, or DLC, are a means for leaders to work closely together to advance the broader DEI strategy across the organization.

We are proud to support our global and local employee resource groups, whose employee-led activities and initiatives we believe continue to foster a sense of belonging for our employees.

We continue to weave DEI into talent conversations, particularly at senior levels, which we believe has contributed to our improved representation of female leaders at Dexcom.

Equity and Inclusion

Our journey to create a more equitable and inclusive workplace continues.

As Dexcom continues to grow and scale, we believe our initiatives have been critical not only for company culture but also for the growing diversity of patients our products will benefit across the globe.

Our human resources team, Employee Resource Group sponsors (ERG), and senior leaders work together to advance the broader equity strategy across the organization.

We are proud to support our ERGs;

their employee-led activities and initiatives foster a sense of belonging throughout all our global locations.

We integrate equity and inclusion into talent conversations, especially at senior levels, making our processes fairer for all Dexcom employees.

Communications and Engagement

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With the implementation of our global market adjustment process, we conduct the gender and ethnicity review annually.

Additionally, in 2023 we identified and engaged a third party consultant to help further evolve our gender and ethnicity pay equity review.

Talent Growth and Development

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Because there is no one-size-fits-all approach to career development, we continue to evolve our curriculum to meet the needs of our diverse workforce.

At this time, our employees have completed over 40,000 hours dedicated to this learning.

Additional details regarding our human capital and other matters can be found in our Sustainability Report.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business