What changed in this filing

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Item 1. Business

2026-02-12 compared with 2025-02-18 · 158 added, 167 removed, 512 unchanged (39% of the section changed)

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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 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.

We launched our latest generation systems, the Dexcom G7 Continuous Glucose Monitoring System, or G7, in 2023, and the Dexcom G7 15 Day Continuous Glucose Monitoring System, or G7 15 Day, in late 2025.

In August 2024, we launched Stelo, our 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.

Dexcom G7 and G7 15 Day

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 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.

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 for iCGMs that outline requirements for assuring CGM accuracy, reliability and clinical relevance, and which also outlines the type of studies and data required to demonstrate acceptable CGM performance.

The G7 is cleared in the United States for all people with diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution.

In April 2025, we obtained marketing authorization from the FDA for the G7 15 Day via the 510(k) review process for people over the age of 18 with diabetes in the United States.

Like the G7, the G7 15 Day is an iCGM classified as a Class II device by the FDA, and is subject to iCGM special controls.

The G7 15 Day extends the wear period to 15.5 days and is generally consistent with our prior generation CGM systems in its technical capabilities and its indications.

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.

Dexcom G7 is cleared in the United States for all people with diabetes ages two years and older, giving more people than ever access to a powerfully simple diabetes management solution.

With an overall Mean Absolute Relative Difference, or MARD, of 8.2%, as well as 94.1% of values within 20% of their comparator, Dexcom G7 is the most accurate CGM cleared by the FDA and is clinically proven to lower A1C (a blood test that provides information about average levels of blood glucose, over the prior three months), reduce hyper- and hypoglycemia, and increase time in range.

The G7 carries forward important features of prior generation Dexcom CGM systems:

G7 15 Day will also be covered for Medicare beneficiaries and has met the category requirements for therapeutic CGM systems set forth by the U.S.

Centers for Medicare & Medicaid Services, or CMS.

With an overall Mean Absolute Relative Difference, or MARD, of 8.0%, as well as 94.2% of values within 20% of their comparator, the G7 15 Day is the most accurate CGM cleared by the FDA and is clinically proven to lower A1C (a blood test that provides information about average levels of blood glucose, over the prior three months), reduce hyper- and hypoglycemia, and increase time in range.

The G7 and G7 15 Day carry forward important features of prior generation Dexcom CGM systems:

• Finger stick elimination.

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

• Extended 10-day disposable sensor.

The G7 also has a number of new or improved features compared to our prior generation devices:

• Extended 15.5 day disposable sensor and 10-day disposable sensor, for the G7 15 Day and G7, respectively.

The G7 and G7 15 Day also have a number of new or improved features compared to our prior generation devices:

• An even more discreet and low profile.

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• Faster warm up.

30-minute sensor warm up, fastest of any CGM on the market.

30-minute sensor warm up for the G7, fastest of any CGM on the market, and 60-minute sensor warm up for the G7 15 Day.

• Expanded time to replace sensors.

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• New indications for use.

Indicated in the United States for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-6 years old.

For the G7, indicated in the United States for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-6 years old.

• Less waste.

Smaller plastic components and packaging, resulting in less waste than the G6.

Other than the foregoing, the G7 is generally consistent with our prior generation CGM systems in its technical capabilities and its indications.

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.

Other than the foregoing, the G7 and the G7 15 Day are generally consistent with our prior generation CGM systems in its technical capabilities and its indications.

Since the G7 and G7 15 Day are classified by the FDA as a Class II device, special controls and modifications of, or revisions to, the device may be made under the 510(k) process.

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 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 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 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.

Dexcom ONE consists of three main components:

a sensor, a transmitter, and a display device consisting of either the Dexcom ONE app for users with a compatible mobile device, or a Dexcom ONE receiver.

We anticipate transitioning our G6 customers to our G7 and G7 15 Day sensor systems by the end of 2026.

In November 2023, we obtained CE Mark approval for our Dexcom ONE+ CGM system, or Dexcom ONE+, which we have launched in several countries in Europe.

Dexcom ONE+ carries many of the same features as the G7, and is indicated for persons, including pregnant women, ages 2 years and older.

Like our other CGM systems, Dexcom ONE+ is designed to replace finger stick blood glucose testing for diabetes treatment decisions.

In November 2023, we obtained CE Mark approval for Dexcom ONE+.

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.

Our previous generation Dexcom ONE CGM system, with similar features as G6, is anticipated to be phased out by the end of 2026.

In August 2024, we launched Stelo, our 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.

By virtue of not requiring a prescription, Stelo expands access to CGM beyond people with diabetes to include those seeking to optimize metabolic health to more effectively and conveniently manage their glucose levels.

Dexcom Share and Dexcom Follow

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 via the Dexcom Follow app.

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.

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These collaborations align with the strategy to seek broader access to our CGM systems for people with Type 2 diabetes, including those who are not treated with intensive insulin therapy.

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 of 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 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.

Market Opportunity

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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.

The ADA also found that in 2022, average medical expenditures among people with diagnosed diabetes were 2.6 times higher than for people without diabetes.

According to the IDF, 2021 expenditures attributable to diabetes were estimated to be $966 billion globally, an increase of 27% from their previous estimate in 2019.

Type 1 Diabetes

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Depending on the severity of Type 2 diabetes, individuals may require diet and nutrition management, exercise, oral medications or insulin injections to regulate blood glucose levels.

We estimate that between 5.0 and 6.0 million people with Type 2 diabetes in the United States must use insulin to manage their diabetes.

Type 2 diabetes is occurring with increasing frequency in young people, with the increase in prevalence related to an increase in obesity amongst children.

According to the CDC, as of 2017-2020, approximately 19.7% of children and adolescents aged 2-19 years, or 14.7 million children, in the United States were obese.

In the United States, the percentage of children and adolescents affected by obesity has more than tripled since the 1970s.

We estimate that greater than 6 million people with Type 2 diabetes in the United States must use insulin to manage their diabetes.

Importance of Glucose Monitoring

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• Potential for Improved Outcomes.

Randomized clinical trials and peer reviewed published data have demonstrated that patients with diabetes who used continuous glucose monitoring devices to help manage their disease experienced significant improvements in glucose control, including when compared to patients relying solely on single-point finger stick measurements (i.e., less time in hypoglycemia and hyperglycemia) and reductions in A1c levels when compared to baseline.

Randomized clinical trials and peer reviewed published data have demonstrated that patients with diabetes who used CGMs to help manage their disease experienced significant improvements in glucose control, including when compared to patients relying solely on single-point finger stick measurements (i.e., less time in hypoglycemia and hyperglycemia) and reductions in A1C levels when compared to baseline.

• Access to Real-Time Values, Trend Information and Alerts.

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Patients can monitor their glucose levels and trends on compatible wearable devices, such as Apple Watch and Wear OS by Google devices, when used with a compatible mobile device.

Also, our Share remote monitoring systems enable users of our current CGM systems to have their sensor glucose information remotely monitored by their family, friends or other designated recipient, or follower, by wirelessly transmitting data from the user’s smart phone to the cloud and then to the follower’s mobile device.

Also, our Share and Follow remote monitoring systems enable users of our current CGM systems to have their sensor glucose information remotely monitored by their family, friends or other designated recipient, or follower, by wirelessly transmitting data from the user’s smart phone to the cloud and then to the follower’s mobile device.

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.

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Compatible Mobile Devices

With our G6 and G7 systems, the functionalities of our proprietary receiver can be obtained through the use of a compatible mobile device, such as an iOS or Android device, and our mobile applications, depending on the patient’s geographic location.

With our G7 and G7 15 Day systems, the functionalities of our proprietary receiver can be obtained through the use of a compatible mobile device, such as an iOS or Android device, and our mobile applications, depending on the patient’s geographic location.

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

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In selling our current CGM systems, we compete directly with the Diabetes Care division of Abbott Laboratories;

Medtronic plc’s Diabetes Group;

Medtronic plc’s Diabetes Group (which implemented a spinoff of its diabetes business into a separate company called MiniMed);

Roche Diabetes Care, a division of Roche Diagnostics;

privately-held LifeScan, Inc.;

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

Ascensia Diabetes Care;

and other smaller market entrants, each of which manufactures and markets products for the single-point finger stick device market.

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

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We have competed with Abbott and their Libre family of CGM products for many years.

Medtronic markets and sells a standalone glucose monitoring product called Guardian Connect, both internationally and in the United States, and a disposable CGM system called Simplera in international markets.

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.

Medtronic (MiniMed) markets and sells a standalone glucose monitoring product called Guardian Connect, both internationally and in the United States, and a disposable CGM system called Simplera in the U.S.

and international markets.

Medtronic (MiniMed) and other third parties have developed or are developing, insulin pumps integrated with CGM 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.

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Some of the companies developing or marketing competing devices are large and well-known publicly traded companies.

Such competitors may benefit from guidance issued on January 6, 2026 by the FDA’s Center for Devices and Radiological Health that effectively broadens the range of products that may be considered “general wellness devices,” including wearables that provide readings around bodily functions and vital signs such as heart rate, blood pressure, and blood glucose.

We believe that the principal competitive factors in our market include:

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Manufacturing

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.

We primarily manufacture our products at our manufacturing facilities in Mesa, Arizona and Penang, Malaysia.

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.

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.

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

There are technical challenges to increasing manufacturing capacity, including 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.

For example, in March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona relating to observed non-conformities in manufacturing

processes and our quality management system.

See the section of the Risk Factors entitled “ Risks Related to Manufacturing, Commercial Operations and Commercialization ” and “ If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, including responding to the FDA warning letter, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.

Additionally, the production of our CGM 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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We purchase certain components and materials used in manufacturing from single sources due to quality considerations, costs or constraints resulting from regulatory or other requirements.

As of December 31, 2024, those single sources include suppliers of application-specific integrated circuits used in our transmitters, seals used for the applicator and certain polymers used to synthesize polymeric membranes for our sensors.

As of December 31, 2025, those single sources include but are not limited to suppliers of application-specific integrated circuits used in our transmitters, seals used for the applicator and certain polymers used to synthesize polymeric membranes for our sensors.

For additional information, please see our Risk Factor entitled “ We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, non-compliance and/or price fluctuations, which could harm our business.

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As a medical device company, coverage and reimbursement from Medicare, Medicaid or other governmental healthcare programs or systems and private third-party healthcare payors is an important element of our success.

Medicare covers the CGM system, which includes supplies necessary for the use of the device, under the Durable Medical Equipment, or DME, benefit category.

Medicare covers the CGM system, which includes both the receiver device and the supplies necessary for the use of the device, under the Durable Medical Equipment, or DME, benefit category.

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 (CMS) released in April 2023 extends Medicare CGM coverage to all patients using insulin.

The Local Coverage Determination, or LCD, that CMS released in April 2023 extended 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, 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 late 2025, CMS extended the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program to include our CGMs and receivers beginning with contracting in 2027, and payment changes effective January 1, 2028.

Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items.

CMS anticipates that ten (10) contracts will be awarded for CGMs.

However, while the competitive bidding program previously used competitive bidding areas, or CBAs, for contract awards, CMS determined that for CGMs and certain other DME, a Remote Item Delivery, or RID, CBA was more appropriate.

It remains to be seen whether CGMs will be covered under a single, nationwide RID CBA or whether regional RID CBAs will be established.

In any event, the bid process is expected to result in lower Medicare reimbursement for CGM systems, particularly because CMS is changing the pricing under the RID CBA by setting a single payment amount for covered items at the 75 th percentile of the winning bids, rather than using the maximum winning bid.

Further, CMS has reclassified CGMs and insulin infusion pumps to items that require frequent and substantial servicing and will phase in monthly rental payments for these items.

CMS will bundle the rental amount for the receiver device with payment for the supplies and accessories in the new payment amount.

Beneficiaries who own their CGMs or insulin infusion pumps may either continue to use them until replacement is necessary or immediately switch to a rental item.

The bid limit will be monthly fee schedule amounts for the supplies plus the average purchase fee schedule amounts for the CGM receiver device divided by 60 (intended to capture the 5-year useful life of the device).

As a result, we expect that Medicare reimbursement for our CGM systems will decrease beginning in 2028.

CMS is required by law to recompete these contracts at least once every three years and to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas to match competitive bidding prices.

The implementation of the competitive bidding program may result in reduced Medicare payment for CGMs in both competitive bidding areas and non-competitive bidding areas.

We also have coverage under certain international markets and Medicaid coverage in approximately 48 states as of December 31, 2025.

As of December 31, 2025, 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 CGM 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

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

In some cases, the patent term may be extended.

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

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

We have launched a number of programs to advocate for individuals living with diabetes and we support our employees and their families through a number of benefit programs that are available.

In addition, we seek to promote diversity, practice fairness, and treat everyone with respect and dignity.

• Think Big – We seek to expand global healthcare access for people with diabetes and actively work to increase access to our products.

We also have committed to operate our business in a manner that is environmentally sustainable and conserves natural resources and reduces waste.

• Be Dependable – We are committed to quality and believe that is best achieved through a safe and healthy workplace as well as a Quality Management System that is compliant with all applicable regulatory requirements and which is continuously being improved.

• Serve with Integrity – While oversight of our ethics and governance structure begins with our Board of Directors and Executive Leadership Team, we expect all employees to foster a culture of accountability in line with our Code of Conduct and Business Ethics.

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 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.

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 strategy with respect to sustainability to align with Dexcom’s mission and long-

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.

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.

Our Board of Directors has delegated responsibility to our Nominating and Governance Committee for the oversight of sustainability matters.

Periodically, the Nominating and Governance Committee oversees and reviews our sustainability policies and programs, oversees and reviews our participation and visibility as a global corporate citizen, and assesses the management of and Dexcom’s performance on sustainability-related impacts, risks, and opportunities, including climate, affecting Dexcom’s business.

Additionally, the Corporate Sustainability Steering Committee, consisting of members of senior management from Legal, Finance, Human Resources, Commercial and Operations, is responsible for establishing programs, policies and practices relating to sustainability matters, under the auspice of the Nominating and Governance Committee.

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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federal level, our products are medical devices subject to extensive and ongoing regulation by the FDA.

Federal Food, Drug and Cosmetic Act, referred to as the FDCA, and the FDA’s implementing 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.

Federal Food, Drug and Cosmetic Act, referred to as the FDCA, and the FDA’s implementing 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 quality, product labeling, product storage, advertising and promotion, product sales, distribution, recalls and field actions, servicing and post-market clinical surveillance, complaint handling, and adverse event reporting.

A number of U.S.

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Unless an exemption applies, each medical device we wish to commercially distribute in the United States will require either prior 510(k) clearance, prior de novo down-classification and a related grant of marketing authorization, or prior approval from the FDA through the premarket approval, or PMA process.

The FDA classifies medical devices into one of three classes.

The FDA classifies medical devices into one of three classes stratified by risk.

Devices requiring fewer controls because they are deemed to pose lower risk are placed in Class I or II.

Class I devices are subject to general controls such as labeling, pre-market notification, and adherence to the FDA’s manufacturing requirements, which are contained in the Quality System Regulation, or QSR.

Class II devices are subject to special controls such as performance standards, post-market surveillance, FDA guidelines, or particularized labeling, as well as general controls.

Some Class I and Class II devices are exempted by regulation from the pre-market notification (i.e., 510(k) clearance) requirement, and/or the requirement of compliance with substantially all of the QSR.

Class I devices are subject to general controls such as labeling, and may be subject to the 501(k) pre-market notification process, and also may require adherence to the FDA’s manufacturing requirements, which are contained in the Quality System Regulation, or QSR, which is in the process of being superseded by the new Quality Management System Regulation, or QMSR, becoming effective February 2, 2026.

The QMSR amends the quality regulations to align more closely with international consensus standards for quality management systems for medical devices used by other regulatory authorities around the world.

Class II devices are typically subject to the requirement stated above and additionally may be subject to special controls such as performance standards, post-market surveillance, FDA guidelines, or particularized labeling, as well as general controls.

Some Class I and most Class II devices are exempted by regulation from the pre-market notification (i.e., 510(k) clearance) requirement, and/or the requirement of compliance with substantially all of the QSR, which as stated above is being superseded by the new QMSR.

As an example, the mobile applications that comprise the Share System were classified by the FDA as Class II exempt.

With the mobile applications classified as Class II exempt, we must comply with certain general and special controls required by the FDA but we do not need prior FDA review to commercialize changes to the mobile applications.

Some devices are placed in Class III, which requires approval of a PMA application, if they are deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices, or to be “not substantially equivalent” either to a previously 510(k) cleared device or to a “preamendment” Class III device in commercial distribution before May 28, 1976 for which PMA applications have not been required.

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.

Some devices are placed in Class III, which requires approval of a PMA application and may require human clinical trials, if they are deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or certain implantable devices,

or to be “not substantially equivalent” either to a previously 510(k) cleared device or to a “preamendment” Class III device in commercial distribution before May 28, 1976 for which PMA applications have not been required.

If a previously unclassified new medical device does not qualify for the 510(k) pre-market notification process because there is no predicate device as to which it may be found to be substantially equivalent as required by the 501(k) notification process that 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.

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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• establishment registration and device listing;

• QSR, which requires manufacturers to follow design, testing, control, storage, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures;

• QSR, to be superseded by the new QMSR as described above, which requires manufacturers to follow design, testing, control, storage, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures;

• labeling regulations, which prohibit the promotion of products for unapproved or off-label uses or indications and impose other restrictions on labeling, advertising and promotion;

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• criminal prosecution.

We and our contract manufacturers, specification developers, and some suppliers of components or device accessories, are also required to manufacture our products in compliance with current Good Manufacturing Practice requirements set forth in the QSR.

The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.

The QSR requires, and in its place the new QMSR will require, a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components or services, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping.

The FDA evaluates compliance with the QSR, and in its place will require compliance with the new QMSR, through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors.

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.

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

In March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona.

In the warning letter, the FDA cited deficiencies in the response letters sent by us to the FDA following the Form 483, List of Investigational Observations that was delivered to us in connection with the inspection of our San Diego, California facility that occurred from October 2024 through November 2024, and the inspection of our Mesa, Arizona facility that occurred in June 2024.

The warning letter describes observed non-conformities in manufacturing processes and our quality management system.

We take the matters identified in the warning letter seriously and have submitted responses to the Form 483 and to the FDA warning letter.

While the warning letter does not restrict our ability to produce, market, manufacture or distribute products, require recall of any products, nor restrict our ability to seek FDA 510(k) clearance of new products, we may fail to satisfy these regulatory requirements to the FDA’s satisfaction, and any failure to do so could result in the foregoing occurring.

See the risk factor entitled “ If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, including responding to the FDA warning letter, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market .”

Fraud and Abuse Laws and Other Compliance Requirements

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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.

payments, and providing anything at less than its fair market value.

Given the breadth of this prohibition, Congress has issued a number of exceptions and has granted authority to the OIG to issue safe harbor regulations, each of which set forth certain provisions which, if satisfied in their entirety, will exempt an arrangement from being found to violate the federal Anti-Kickback Statute.

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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.

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.

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.

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There are certain exceptions to the definition of remuneration for offerings that meet the Financial Need, Preventative Care, or Promoting Access to Care exceptions.

Sanctions for violations of the CMPL include civil monetary penalties and administrative penalties up to and including exclusion from participation in federal health care programs.

Sanctions for violations of the CMPL

include civil monetary penalties and administrative penalties up to and including exclusion from participation in federal health care programs.

We are not a “provider, practitioner or supplier” to which the Beneficiary Inducement CMP applies as we do not directly bill Medicare;

therefore, our liability under the Beneficiary Inducement CMP is materially reduced.

Violations of the Stark Law, the Anti-Kickback Statute, the Civil Monetary Penalties Law and/or the federal False Claims Act can also form the basis for exclusion from participation in federal and state healthcare programs.

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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.

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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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.

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

The FTC has also pursued enforcement actions against companies for violations of its Health Breach Notification Rule and the Children’s Online Privacy Protection Act.

Our use of personal information is also subject to our published privacy policies and notices.

Further, certain states have proposed or enacted legislation that will create new data privacy and security obligations for certain entities.

These laws include, for example, the California Consumer Privacy Act, or CCPA, which came into effect January 1, 2020 and was amended and expanded by the California Privacy Rights Act, or CPRA, which came into effect on January 1, 2023;

the Virginia Consumer Data Protection Act, effective as of January 1, 2023;

the Colorado Privacy Act and the Connecticut Data Privacy Act, both effective as of July 1, 2023;

the Utah Consumer Privacy Act, effective as of December 31, 2023;

the Washington My Health My Data Act and Nevada Senate Bill 370, both effective as of March 31, 2024;

the Oregon Consumer Privacy Act, the Texas Data Privacy and Security Act, and the Florida Digital Bill of Rights, all effective as of July 1, 2024;

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

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;

and the Indiana Consumer Data Protection Act, effective as of January 1, 2026.

Several other states have enacted, or are proposing to enact, their own comprehensive privacy laws.

Further, nearly half of the U.S.

states have enacted legislation that creates new data privacy and security obligations for certain entities.

Several other states are proposing to enact, their own comprehensive privacy laws.

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.

A particular focus of legislatures appears to be consumer health data which is not subject to HIPAA, as evidenced by passage of the Washington My Health My Data Act and Nevada Senate Bill 370.

In addition, some states have adopted legislation focused on protections pertaining to consumer health data that is not subject to HIPAA, as evidenced by passage of the Washington My Health My Data Act and similar laws passed, for example, in Connecticut and Nevada.

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, but many questions remain as to how all of the new statutes will be interpreted and enforced.

The state laws are not uniform and we must evaluate to what extent the laws apply to our operations.

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

They may also cause us to incur substantial costs and expenses to ensure ongoing compliance, particularly given our base of operations in California.

The laws may also cause us to incur substantial costs and expenses to ensure ongoing compliance, particularly given our base of operations in California.

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.

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The scope of the FCPA would include interactions with certain healthcare professionals in many countries, either directly or through our contracted distributors.

On February 10, 2025, the Trump Administration issued an executive order, “Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security”, pausing FCPA enforcement for a period of 180 days while new guidelines were developed that prioritized American economic competitiveness and efficiency of government resources;

however, on June 9, 2025, the Deputy Attorney General issued a memorandum pursuant to the executive order’s directive, titled “Guidelines for Investigations and Enforcement of the Foreign Corrupt Practices Act (FCPA)”, which detailed the administration’s new FCPA guidelines for current and future investigations and enforcement priorities.

Then on August 11, 2025, the DOJ unsealed its first FCPA indictment since the pause in FCPA enforcement.

The indictment described conduct similar to matters previously pursued under the FCPA prior to the executive pause order;

however, certain elements of the conduct and the allegations aligned with the policy goals expressed in the updated guidelines.

Therefore, the FCPA remains applicable to our operations and we continue to expend resources to ensure that our activities comply.

Our present and future business has been and will continue to be subject to various other U.S.

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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 $1,406,728 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.

These repayments are published, with annual updates released on June 30 each year, and available on CMS’ Open Payments website.

While there are exceptions to this transparency reporting, the rules are highly technical and require close monitoring and analysis to ensure continued compliance.

Initial penalties under the Sunshine Act were civil fines that ranged from $1,000 to $100,000 per violation (adjusted annually) with a $1 million cap (adjusted annually).

However, due to annual adjustments, the annual penalty cap for 2025 was $1,443,275.

Depending on the circumstances, 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.

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The need to build and maintain a robust compliance program with different compliance and/or reporting requirements increases the possibility that a company may violate one or more of the requirements, resulting in fines and penalties.

We continue to expend resources to ensure our continued compliance with these transparency reporting laws.

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.

The regulatory framework governing medical devices is largely harmonized within the European Union, which includes most of the major countries in Europe.

Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices.

The European Union has adopted numerous directives and standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices.

To be placed on the European Union market, devices must undergo a conformity assessment and bear the CE mark, indicating that the device conforms to the essential requirements of the applicable rules.

The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third-party assessment by a “Notified Body.” This third-party assessment, which may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s product, is always required in order for a manufacturer to commercially distribute the product throughout the European Union, except in case of Class I medical devices (those entailing the lowest level of risk).

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

The European Union Medical Device Regulation, or MDR, went into force in 2017, and replaced the existing Directive.

The MDR initially provided three years for transition and compliance, which was subsequently extended to May 2026, December 2027, or December 2028, depending on the device classification.

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.

The regulatory framework governing medical devices is largely harmonized within the European Economic Area, or EEA, which includes the 27 member states of the European Union, or EU, plus Norway, Iceland, and Liechtenstein.

Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the EU/EEA with respect to medical devices.

In the EU/EEA, Regulation (EU) 2017/745, or MDR, regulates the design, manufacture, clinical evaluation, labeling, placing on the market, and adverse event reporting for medical devices.

The MDR was approved in 2017, replacing Council Directives 90/385/EEC and 93/42/EEC, and became applicable in the EU/EEA on May 26, 2021, changing several aspects of the existing regulatory framework.

The MDR initially provided for a three-year transitional period, which was subsequently extended in 2023.

As a result, medical devices certified under the former Council Directives 90/385/EEC or 93/42/EEC must now comply with the MDR by May 26, 2026, December 31, 2027, or December 31, 2028, depending on their risk classification.

To be placed on the EU/EEA market, all medical devices must undergo a conformity assessment and bear the CE Mark, indicating that the device conforms to the essential requirements of the MDR.

As a general rule, demonstration of conformity of medical devices must be based on clinical data supporting the safety and performance of the products.

Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, 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 are supported by suitable evidence.

The method of assessing conformity varies depending on the class of the product.

For low-risk medical devices (Class I with no measuring function and which are not sterile), the manufacturer can perform a self-assessment.

For all other devices (Class IIa, IIb, and III), the conformity assessment requires the intervention of a Notified Body, i.e.

an independent third-party organization designated by the competent authority of an EU/EEA member state.

Depending on the applicable conformity assessment route, the Notified Body assesses and audits the manufacturer’s technical documentation and quality management system, covering the manufacture, design, and final inspection of the devices.

Upon successful completion of the conformity assessment procedure, the Notified Body issues the CE Certificate of Conformity, which entitles the manufacturer to affix the CE Mark.

On December 16, 2025, the European Commission, or EC, published a proposal to revise the MDR.

The proposal introduces several measures that would have a significant impact on the medical device industry, including:

• Amendments to classification rules, which may result in a lower risk classification for certain products, including medical device software.

These changes could also reduce the number of AI-enabled medical devices classified as “high-risk” under the EU AI Act (Regulation (EU) 2024/1689);

• Clarification of the interplay with the AI Act, providing that most requirements applicable to high-risk AI systems under the AI Act would not apply to AI-based medical devices, in order to avoid regulatory overlaps;

• Extension of CE Certificate validity, by removing the current five-year maximum validity period for CE Certificates of Conformity issued by Notified Bodies.

The proposal will now undergo the ordinary legislative procedure and be examined by the European Parliament and the Council, which may introduce amendments to the text proposed by the EC.

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

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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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.

MedTech Europe, the medical device industry association, also introduced the Code of Ethical Business Practices, which came into effect on January 1, 2017.

MedTech Europe, the medical device industry association, also introduced the Code of Ethical Business Practices, which came into effect on January 1, 2017 and was updated with effect from January 1, 2023.

Countries in Asia have also become more active in their enforcement of anti-bribery laws and with respect to procurement and supply chain fraud.

In the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of patient data across the healthcare industry became effective in May 2018.

The EU General Data Protection Regulation, or GDPR, applies across the European Union 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 non-compliance.

In the EU, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of patient data across the healthcare industry became effective in May 2018.

The EU General Data Protection Regulation, or GDPR, applies across the EU and European Economic Area 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 non-compliance.

The GDPR fine framework can be up to 20 million euros, or up to 4% of the company’s total global turnover of the preceding fiscal year, whichever is higher.

The GDPR also requires companies processing personal data of individuals residing in the European Union to comply with EU privacy and data protection rules, even if the company itself does not have a physical presence in the European Union.

The GDPR also requires companies processing personal data of individuals residing in the EU and European Economic Area to comply with EU privacy and data protection rules in certain circumstances, even if the company itself does not have a physical presence in the EU or European Economic Area.

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

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

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

We expect continued costs associated with maintaining compliance with GDPR into the future.

For example, on July 16, 2020, the Court of Justice of the European Union issued a judgment in Case C-311/18 that declared the EU-U.S.

For example, on July 16, 2020, the Court of Justice of the EU issued a judgment in Case C-311/18 that declared the EU-U.S.

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

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

Data Privacy Framework) has been adopted, and it may also be subject to challenges similar to those faced by the Privacy Shield.

Data Privacy Framework) has been adopted, it may also be subject to challenges similar to those faced by the Privacy Shield.

In view of this and other developments, data transfer risk remains a potential issue that requires regular monitoring.

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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.

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

In the EU, several recently adopted or proposed legislative initiatives may affect our business.

In addition to the proposed revision of the MDR, these include the AI Act (Regulation (EU) 2024/1689), the Data Act (Regulation (EU) 2023/2854), the Health Data Space Regulation (Regulation (EU) 2025/327), the Regulation on Health Technology Assessment (Regulation (EU) 2021/2282), the Battery Regulation (Regulation (EU) 2023/1542), and the Network and Information Security Directive (NIS 2) (Directive (EU) 2022/2555), among others.

Moreover, the EU is currently discussing the Digital Omnibus Package, which comprises a series of technical amendments to a wide body of EU digital legislation.

In particular, the Digital Omnibus Package consists of two legislative proposals:

• A first proposal introducing amendments to several pieces of legislation, including Regulation (EU) 2016/679 (GDPR), the ePrivacy Directive (Directive 2002/58/EC), the NIS2 Directive and other instruments relating to cybersecurity (DORA, CER, eIDAS), and the Data Act;

• A second proposal aimed at amending the AI Act to support its smooth and effective application and to ensure its consistent implementation across the EU.

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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We capture ethnic diversity data in the United States only, comprised of the following categories:

Black or African American, Hispanic or Latino, Asian, American Indian/Alaskan Native, Native Hawaiian or Other Pacific Islander, Two or More Races.

Black or African American, Hispanic or Latino, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, Two or More Races.

**Includes full-time and part-time employees.

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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.

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

We are proud to support our ERGs;

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Our goal to support our employees’ needs remains constant.

We continued to provide both COVID and flu vaccination clinics for employees and their families, and continued support of remote work for employees whose roles allow for it.

We also continue to evaluate how to maintain a hybrid workplace beyond the pandemic to ensure that we meet our employees’ ever-changing needs outside the workplace.

We continued to provide vaccination clinics for employees and their families, and continued support of remote and hybrid work for employees whose roles allow for it.

Total Rewards and Pay Equity

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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