What changed in this filing

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Item 1. Business

2023-02-09 compared with 2022-02-14 · 212 added, 177 removed, 511 unchanged (43% of the section changed)

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

We launched our latest generation system, the Dexcom G6 ® integrated Continuous Glucose Monitoring System, or G6, in 2018.

We received FDA marketing authorization and launched our latest generation system, 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 ® in December 2022.

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

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The reports are also available at www.sec.gov.

Also available on our website are printable versions of our Audit Committee charter, Compensation Committee charter, Nominating and Corporate Governance Committee charter, and Code of Conduct and Business Ethics.

Stockholders may request copies of these documents by mail or telephone, at the address or phone number provided above.

Product Candidates

We are pursuing regulatory approvals for our next generation G7 CGM system.

The G7 is designed with the goal of carrying forward many of the same features as our G6 CGM system and adding several new or improved features, including:

• Reduced size .

A 60% reduction in size of the on-body wearable.

• Fully disposable .

Sensor and transmitter combined into a single, disposable wearable.

• Simple application .

New application process streamlines the number of steps required.

• Faster warmup .

Warmup period expected to be reduced from the current two-hour warmup for G6.

• Reduced packaging waste .

Significant reduction to the product packaging waste profile on a per unit basis.

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 dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.

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.

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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 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.

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

Our receiver is also reusable.

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• Continuous glucose readings.

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

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 other people for added support and care coordination.

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 sugars.

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.

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.

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• Medication blocking.

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

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

• Predictive low alert.

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

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

• Extended 10-day disposable sensor.

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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 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.

We are working to obtain reimbursement coverage by Medicare and Medicaid and by commercial insurers in the United States.

Dexcom G7 is now 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%, 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:

• 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.

• 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.

• Designed to integrate with the world’s largest connected CGM ecosystem (including insulin pumps and smart insulin pens, 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.

• Easy sensor application.

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

• Medication blocking.

New feature 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.

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

• An even more discreet and low profile.

A redesigned transmitter makes for an all-in-one wearable combining our sensor and transmitter that is 60% smaller than the G6, making it even more comfortable and easier to wear under clothing.

• Faster warm up.

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

• Expanded time to replace sensors.

12-hour grace period to replace finished sensors for a more seamless transition between sessions.

• New mobile app.

Redesigned and simplified mobile app with Dexcom Clarity integration.

• Improved alert settings for enhanced discretion at the user’s option .

• Redesigned receiver.

The optional receiver is smaller, with a more vibrant, easier to read display.

• 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 2-17 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.

Dexcom Share ®

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Dexcom Real-Time API

In July 2021, we received FDA 510(k) clearance for our Real-Time API, which expands connectivity and interoperability of the Dexcom CGM digital ecosystem.

Dexcom Real-Time API enables invited third-party developers to integrate real-time CGM data into their digital health apps and devices.

In July 2021, we obtained CE Mark approval for our new Dexcom ONE CGM system, or Dexcom ONE, which we have launched in four countries:

Bulgaria, Estonia, Latvia and Lithuania.

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 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 Dexcom ONE sensor, a Dexcom ONE transmitter, and a Dexcom ONE app as the display device for users with a compatible mobile device.

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.

Dexcom ONE carries many of the same features as the G6, and is indicated for persons, including pregnant women, ages 2 years and older.

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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.

some cases, use the glucose readings for semi-automated insulin delivery.

Currently, we have announced significant insulin delivery partnerships with Eli Lilly, Insulet, Novo Nordisk, Tandem Diabetes and The Ypsomed Group.

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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 and incentive payments, and will make potential additional milestone payments for future product regulatory approval and sales-based milestones.

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, and product regulatory approval milestone payments, and will make potential additional milestone payments for future sales-based milestones.

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

If we elect to make these milestone payments 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.

See Note 2 “Development and Other Agreements” to the consolidated financial statements in Part II, Item 8 and Exhibit 10.31 of this Annual Report for a further description of the Restated Collaboration Agreement, including the number of shares of stock for milestone payments.

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

See Note 2 “Development and Other Agreements” to the consolidated financial statements in Part II, Item 8 of this Annual Report and Exhibit 10.15 of this Annual Report 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 IDF, there were an estimated 6.7 million deaths attributable to diabetes globally in 2021 between the ages of 20 and 79 years.

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

According to the ADA, one in every four healthcare dollars was spent on treating people with diabetes in 2017, and the direct medical costs and indirect expenditures attributable to diabetes in the United States were an estimated $327 billion, an inflation-adjusted increase of approximately 26% since 2012.

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Individuals with Type 1 diabetes must rely on frequent insulin injections in order to regulate and maintain blood glucose levels.

According to JDRF, greater than 60,000 people are diagnosed with Type 1 diabetes each year in the United States and 5 million people in the U.S.

are expected to have Type 1 diabetes by 2050.

According to JDRF, greater than 60,000 people are diagnosed with Type 1 diabetes each year in the United States.

In addition, according to the ADA in 2019, nearly 18,000 youth are newly diagnosed with Type 1 diabetes every year in the United States.

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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.

Childhood obesity has more than doubled in children and quadrupled in adolescents in the past 30 years.

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

Importance of Glucose Monitoring

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People with diabetes may also suffer pain when the finger prick site is disturbed during regular activities.

The Dexcom Solution

The Dexcom Approach

We believe continuous glucose monitoring has the potential to enable more people with diabetes to achieve and sustain tight glycemic control with minimal disruption to their daily lives.

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One such automated insulin delivery system that uses the G6 was studied in a large clinical trial that associated its use with numerous quality-of-life and glycemic benefits.

Our current target market consists primarily of people with Type 1 and Type 2 diabetes who utilize insulin pump therapy or who utilize multiple daily insulin injections.

We also believe that our CGM systems are beginning to have a positive impact

on the broader Type 2 population that does not utilize mealtime insulin, a group that we estimate to be greater than 30 million people in the United States alone.

Our current target market consists primarily of people with Type 1 and Type 2 diabetes who utilize insulin therapy.

We also believe that our CGM systems are beginning to have a positive impact on the broader Type 2 population that does not utilize insulin, a group that we estimate to be approximately 30 million people in the United States alone.

We are extending our commercial efforts for this population through several channels, including through strategic partnerships.

In the future, we plan to expand our product offering and cleared/approved indications to address people with pre-diabetes, people who are obese, people who are pregnant, and people in the hospital setting.

Although the majority of our revenue has been generated in the United States, we have expanded our operations to include certain countries in Africa, Asia, Europe, Latin America, and the Middle East, as well as Australia, Canada, and New Zealand.

Our current CGM systems offer the following advantages to people with diabetes:

• Improved Outcomes.

Although the majority of our revenue has been generated in the United States, we have expanded our operations to include additional markets in North America, Africa, Asia Pacific, Europe, Latin America and the Middle East.

Our current CGM systems offer the following potential advantages to people with diabetes:

• 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.

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

At their fingertips, people with diabetes can view their current glucose value, along with a graphical display of the historical trend information on our receiver or alternate display device.

People with diabetes can view their current glucose value, along with a graphical display of the historical trend information on our receiver or alternate display device.

Without continuous monitoring, the individual is often unaware if his or her glucose is rising, declining or remaining constant.

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In addition, we continue to pursue development partnerships with other insulin delivery companies, including automated insulin delivery systems, as well as other players in the disease management sector.

To achieve these objectives, we are focusing on the following business strategies:

We are focusing on the following business strategies as we pursue these objectives:

• Establishing and maintaining our technology platform as the leading approach to CGM and leveraging our development expertise to rapidly bring products to market, including for expanded indications.

• Driving the adoption of our ambulatory products through a direct sales and marketing effort, as well as key distribution arrangements.

• Driving additional adoption through technology integration partnerships such as our current partnerships with Eli Lilly, Insulet, Novo Nordisk, Tandem Diabetes, The Ypsomed Group and others globally.

• Supporting use of our ambulatory products through a direct sales and marketing effort, as well as key distribution arrangements.

• Supporting innovation through technology integration partnerships such as our current partnerships with Eli Lilly, Insulet, Novo Nordisk, Tandem Diabetes, The Ypsomed Group and others globally.

• Seeking broad coverage policies and reimbursement for our products from private third-party payors and national health systems.

• Driving increased utilization and adoption of our products through a cloud-based data repository platform that enables people with diabetes to aggregate and analyze data from numerous diabetes devices and share the data with their healthcare providers and other individuals involved in their diabetes management and care.

• Expanding the use of our products to other patient care settings and patient demographics, including use for people with Type 2 diabetes who are not on intensive insulin therapy, population health, patient monitoring including in the hospital setting, and people who are pregnant.

• Providing cloud-based data repository platform that enables people with diabetes to aggregate and analyze data from numerous diabetes devices and share the data with their healthcare providers and other individuals involved in their diabetes management and care.

• Pursuing expansion of use of our products to other patient care settings and patient demographics, including use for people with Type 2 diabetes who are not on intensive insulin therapy, population health, patient monitoring including in the hospital setting, and people who are pregnant.

• Providing a high level of customer support, service and education.

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The user then disposes of the insertion device and snaps the transmitter to the pod.

After a stabilization period with the G6, the user will begin receiving CGM data on his or her mobile device or dedicated receiver through the ten-day usage period.

Our G6 system has labeling from the FDA and CE Mark permitting their use as a replacement for finger sticks for making therapeutic adjustments.

The disposable sensor contained in the G6 system is intended to function for up to ten days, after which the sensor should be replaced.

After a stabilization period, the user will begin receiving CGM data on his or her mobile device or dedicated receiver through the ten-day usage period.

Our G6 and G7 systems have labeling from the FDA and CE Mark permitting their use as a replacement for finger sticks for making therapeutic adjustments.

The disposable sensors contained in the G6 and G7 systems respectively are each intended to function for up to ten days, after which the sensor should be replaced.

To replace a sensor, the user simply removes the pod and attached sensor from the skin and discards them while retaining the reusable transmitter.

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Our small handheld receiver is carried by the user and wirelessly receives continuous glucose values from the transmitter.

Proprietary algorithms and software, developed from our extensive database of continuous glucose data from clinical trials, are programmed into the G6 transmitter to process the glucose data from the sensor, which then sends the processed glucose data to the receiver and displays it on a user-friendly graphical user interface.

Proprietary algorithms and software, developed from our extensive database of continuous glucose data from clinical trials, are programmed into the G6 and G7 transmitter to process the glucose data from the sensor, which then sends the processed glucose data to the receiver and displays it on a user-friendly graphical user interface.

With a push of a button, the user can access their current glucose value and one-, three-, six-, twelve- and twenty-four-hour trended data.

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Compatible Mobile Devices

With our G6 system, 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 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.

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

Products in Development

We have gained our technology expertise by learning to design implants that can withstand the rigors of functioning within the human body for extended periods of time, as well as other issues such as device sealing, miniaturization, durability and sensor geometry.

We are leveraging this technology platform to enhance the capabilities of our current products (including obtaining expanded indications of use) and to develop additional CGM products.

We plan to develop future generations of technologies focused on improved performance and convenience and that will enable intelligent insulin administration.

We have gained our technology expertise by developing implants designed to withstand the rigors of functioning within the human body for extended periods of time, and designed to address other considerations such as device sealing, miniaturization, durability and sensor geometry.

We are leveraging this technology platform with the goal of enhancing the capabilities of our current products (including obtaining expanded indications for use) and to develop additional CGM products.

We plan to develop future generations of technologies focused on improved performance and convenience that will enable intelligent insulin administration.

Over the longer term, we plan to continue to develop and improve networked platforms with open architecture, connectivity and transmitters capable of communicating with other devices.

We intend to expand our efforts to accumulate CGM patient data and metrics and apply predictive modeling and machine learning to generate interactive CGM insights that can inform patient behavior.

We intend to expand our efforts to accumulate CGM patient data and metrics and apply predictive modeling and machine learning to generate interactive CGM insights with the potential to inform patient behavior.

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.

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Commercial Operations

We have built a direct sales organization in the United States, Australia, Canada, New Zealand, and some countries in Europe to call on health care professionals, such as endocrinologists, physicians and diabetes educators, who can educate and influence patient adoption of continuous glucose monitoring.

We believe that focusing efforts on these participants is important given the instrumental role they each play in the decision-making process for diabetes therapy, and to ensure that health care professionals and patients are knowledgeable about our products and their functionality.

We have built a direct sales organization in North America and certain international markets to call on health care professionals, such as endocrinologists, physicians and diabetes educators, who can educate patients about continuous glucose monitoring.

We believe that focusing efforts on these participants is important given the instrumental role they each play in the decision-making process for diabetes therapy, and to ensure that health care

professionals and patients are knowledgeable about our products and their functionality.

We focus on delivering this important information to participants to drive adoption of our current CGM systems.

We directly market our products in the United States, Austria, Canada, Germany, Ireland, Switzerland, and the United Kingdom primarily to endocrinologists, physicians and diabetes educators.

To complement our direct sales efforts, we have entered into distribution arrangements in the United States, and certain countries in Africa, Asia, Europe, Latin America, and the Middle East, as well as Australia, Canada, and New Zealand that allow distributors to sell our products.

In addition, our direct sales efforts include the use of e-commerce resources in certain international markets where we have not built a sales force.

To complement our direct sales efforts, we have entered into distribution arrangements in North America and several international markets that allow distributors to sell our products.

We expect to continue investing in our field sales force and believe our direct, highly specialized and focused sales organization and our domestic and international distribution agreements are sufficient for us to support our sales efforts for at least the next twelve months.

Direct to consumer marketing is one of our key initiatives to increase awareness of our CGM systems and drive new patient leads to our website.

We target people with Type 1 and insulin intensive Type 2 diabetes.

We advertise on television, in print, digital and video media, CRM, offer sponsorships, host or participate in diabetes related events, conduct public relations and maintain a brand ambassador program.

Our campaigns target people with diabetes.

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

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;

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• 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.

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

We typically experience seasonality, with lower sales in the first quarter of each year compared to the immediately preceding fourth quarter.

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annual insurance deductible resets and unfunded flexible spending accounts.

The market for blood glucose monitoring devices is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.

The market for glucose monitoring devices is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.

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

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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.

We also have begun to become 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.

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.

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

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Manufacturing

We currently manufacture our products at our headquarters in San Diego, California and at our manufacturing facility in Mesa, Arizona.

As of December 31, 2021, we had approximately 64,000 square feet of laboratory space and approximately 101,500 square feet of controlled environment rooms.

In 2020, we commenced construction of a new facility in Malaysia that we anticipate will add substantial manufacturing capacity.

We currently manufacture our products at our headquarters in San Diego, California and at our manufacturing facility in Mesa, Arizona, where we have approximately 46,800 square feet of laboratory space and approximately 85,200 square feet of controlled environment rooms.

We are also near completion of the initial phase of construction of a new facility in Malaysia that we anticipate will add substantial manufacturing capacity.

There are technical challenges to increasing manufacturing capacity, finding or enhancing new manufacturing facilities capable of meeting regulatory requirements, U.S.

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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, 2021, 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, 2022, 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.

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 .” For supply risks related to COVID-19, see our Risk Factor entitled “ The outbreak of the SARS-CoV-2 virus and its variants and the COVID-19 disease that it causes, or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including our manufacturing, commercial operations and sales .”

Third-Party Reimbursement

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

In January 2017, the Centers for Medicare and Medicaid, or CMS, established a classification of “Therapeutic Continuous Glucose Monitors” as durable medical equipment under Medicare Part B, subject to payment by Medicare under certain coverage conditions to be determined by CMS, by local Medicare Administrative Contractors or on a patient claim by claim basis.

In September 2016, Germany’s Federal Joint Committee agreed to provide reimbursement for continuous glucose monitoring systems under certain conditions which we believe we meet.

Third-Party Coverage and Reimbursement

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.

In January 2017, the Centers for Medicare and Medicaid, or CMS, established a classification of “Therapeutic Continuous Glucose Monitors” as durable medical equipment under Medicare Part B, subject to payment by Medicare under certain coverage conditions which are determined and updated by CMS, by local Medicare Administrative Contractors or on a patient claim by claim basis.

In December 2021, CMS published a final rule expanding the classification of DME under Medicare Parts B & C to also include adjunctive CGMs (i.e., CGMs do not replace standard blood glucose monitors for treatment decisions) and related supplies.

We also have coverage under certain international markets and Medicaid coverage in about 45 states.

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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.

We have personnel with reimbursement expertise to assist customers in obtaining reimbursement from private third-party payors.

We have personnel with reimbursement expertise to assist customers in obtaining reimbursement from

private third-party payors.

We also maintain a field-based reimbursement team charged with calling on third-party private payors to obtain coverage decisions and contracts.

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We seek to protect our proprietary information and other intellectual property by generally requiring our employees, consultants, contractors, suppliers, outside scientific collaborators and other advisors to execute non-disclosure and assignment of invention agreements on commencement of their employment or engagement.

Agreements with our employees also forbid

them from bringing the proprietary rights of third parties to us.

Agreements with our employees also forbid them from bringing the proprietary rights of third parties to us.

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

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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.

Corporate Responsibility

We strive to advance the interests of all our stakeholders – including patients, caregivers, employees, investors, and our communities – by operating in an ethical and sustainable way.

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 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 activities.

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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• 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 protective of the environment and conserves natural resources and reduces waste.

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.

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

Our Nominating and Governance Committee of the Board of Directors oversees and reviews annually (a) our policies and programs concerning (i) corporate social responsibility and (ii) our participation and visibility as a global corporate citizen;

(b) our sustainability performance;

and (c) the assessment and management of environmental, sustainability and governance risks affecting our business.

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

The Nominating and Governance Committee of the Board of Directors oversees and reviews Dexcom’s environmental, social and governance (“ESG”) risks, opportunities, strategies, programs, policies, practices, measures, objectives and performance relating to ESG matters.

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

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

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.

Government Regulation

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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.

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.

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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.

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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• regulatory inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials;

• changes in governmental regulations or administrative actions applicable to our trial protocols;

• changes in governmental regulations or administrative actions applicable to our trial protocols, including, for example, recent legislation passed by Congress requiring clinical trial sponsors to increase engagement with the FDA on matters related to appropriate representation of racial and ethnic minorities in clinical trial data for pivotal studies;

• the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness;

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Also, the FDA may require us to conduct post-market surveillance studies or order us to establish and maintain a system for tracking our products through the chain of distribution to the patient level.

The FDA and the Food and Drug Branch of the

California Department of Health Services enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.

The FDA and the Food and Drug Branch of the California Department of Health Services enforce regulatory requirements by conducting

periodic, unannounced inspections and market surveillance.

Inspections may include the manufacturing facilities of our subcontractors.

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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 the referral of an individual, or the furnishing, recommending, or arranging for the referral 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, waiver of 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 assure parties to the arrangement that they will not be prosecuted under the federal Anti-Kickback Statute.

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.

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.

The failure of a transaction or arrangement to fit precisely within one or more exceptions or safe harbors is not per se illegal;

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Federal Civil False Claims Act.

The federal Civil False Claims Act prohibits knowingly presenting, or causing to be presented a false claim or the knowing use of false statements or records to obtain payment from the federal government.

When an entity is determined to have violated the False Claims Act, it may be subject to repayment of three times the actual damages sustained by the government, plus mandatory civil penalties of between $11,803 and $23,607 (adjusted for inflation) for each separate false claim.

The federal Civil False Claims Act prohibits, among other things, knowingly presenting, or causing to be presented a false claim or the knowing use of false statements or records to obtain payment from the federal government.

When an entity is determined to have violated the False Claims Act, it may

be subject to repayment of three times the actual damages sustained by the government, plus significant mandatory civil penalties for each separate false claim.

Suits filed under the False Claims Act can be brought by any individual on behalf of the government and such individuals (known as “relators” or, more commonly, as “whistleblowers”) may share in any amounts paid by the entity to the government in fines or settlement.

These whistleblower-initiated False Claims Act cases are commonly referred to as “qui

tam” actions.

These whistleblower-initiated False Claims Act cases are commonly referred to as “qui tam” actions.

False Claims Act cases may also be initiated by the U.S.

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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 showed increased interest in pharmaceutical 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.

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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Violations of the Stark Law must be reported and payment for improper referrals returned to Medicare in order to avoid potential liability under the federal False Claims Act for avoiding a known obligation to return identified overpayments.

In the fall of 2020, we transitioned our Medicare business to distributors and no longer bill Medicare directly for DME and related supplies.

In the fall of 2020, we transitioned our Medicare business to distributors and we no longer bill Medicare directly for DME and related supplies.

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

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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 excluded individual, 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 beneficiary selection of a particular provider or supplier for which payment may be made in whole or part by a federal health care program, commonly known as the Beneficiary Inducement CMP.

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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healthcare fraud and false statements relating to healthcare matters.

The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors.

The healthcare fraud statute prohibits knowingly and willfully executing a scheme to

defraud any healthcare benefit program, including private payors.

A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs.

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Privacy Laws and Regulations.

HIPAA, as well as a number of other federal and state privacy-related laws, also extensively regulate the use and disclosure of individually identifiable health information, known as “protected health information,” and require covered entities, including health plans and most health care providers, to implement administrative, physical and technical safeguards to protect the security of such information.

Certain provisions of the security and privacy regulations apply to business associates (entities that handle protected health information on behalf of

covered entities), and business associates are subject to direct liability for violation of these provisions.

HIPAA, as well as a number of other federal and state data protection laws, also extensively regulate the use and disclosure of individually identifiable health information, and other personal information.

HIPAA requires covered entities, including health plans and most health care providers, to implement administrative, physical and technical safeguards to protect the 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.

Certain provisions of HIPAA’s security and privacy regulations apply to business associates (entities that handle protected health information on behalf of covered entities), and business associates are subject to direct liability for violation of these provisions.

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.

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

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

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

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.

The OCR enforces the regulations and performs compliance audits.

The OCR enforces the HIPAA regulations and performs compliance audits.

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

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

In addition to enforcement by OCR, state attorneys general are authorized to bring civil actions seeking either injunction or damages in response to violations that threaten the privacy of state residents.

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There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns.

We also remain subject to federal or state privacy-related laws that are more restrictive than the privacy regulations issued under HIPAA.

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

These laws vary and could impose additional penalties.

For example, the Federal Trade Commission uses its consumer protection authority to initiate enforcement actions in response to alleged privacy and data security violations.

Further, certain states have proposed or enacted legislation that will create new data privacy and security obligations for certain entities, such as 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, passed on November 3, 2020.

The CCPA and CPRA, among other things, create new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

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

These new laws include 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, passed on November 3, 2020, and effective as of 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;

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

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.

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.

It remains unclear what, if any, additional modifications will be made to the CPRA by the California legislature or how it will be interpreted.

Therefore, the effects of the CCPA and CPRA are significant and have required us to modify our data processing practices, and may cause us to incur substantial costs and expenses to ensure ongoing compliance, particularly given our base of operations in California.

Other states are also seeking to regulate consumer privacy stringently, and both Virginia and Colorado signed comprehensive privacy legislation into law in 2021.

These laws (the Virginia Consumer Data Protection Act and the Colorado Privacy Act) are set to come into force in 2023 and a number of other state legislatures are actively considering passing similar consumer privacy laws, including those in New York and Washington.

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation passed in 2022 and beyond, as the increased cyber-attacks during the COVID-19 pandemic have once again put a spotlight on data privacy and security in the U.S.

Draft regulations implementing the CPRA and Colorado statute have been published, but many questions remain as to how all of the new statutes will be interpreted.

The, the effects of state data protection laws are significant and have required us to modify our data processing practices, and may cause us to incur substantial costs and expenses to ensure ongoing compliance, particularly given our base of operations in California.

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation passed in 2023 and beyond, as the increased cyber-attacks during the ongoing COVID-19 pandemic have once again put a spotlight on data privacy and security in the U.S.

and other jurisdictions.

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corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad.

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

The scope of the FCPA would include interactions with certain healthcare

professionals in many countries, either directly or through our contracted distributors.

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

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As a manufacturer of U.S.

FDA‑regulated devices reimbursable by federal healthcare programs, we are subject to this law, which requires us to track and annually report certain payments and other transfers of value we make to U.S.-licensed physicians or U.S.

FDA‑regulated devices reimbursable by federal healthcare programs, we are subject to this law, which requires us to track and annually report certain direct or indirect payments and other transfers of value we make to certain U.S.-licensed health care practitioners and U.S.

teaching hospitals.

We are also required to report certain ownership interests held by physicians and their immediate family members.

In 2018, the law was extended to require tracking and reporting of transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners.

Reporting requirements will go into 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 $1.15 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 physicians and academic medical institutions, which may have implications under the Anti-Kickback Statute and other healthcare laws.

In addition, there has been a recent trend of increased federal and state regulation of payments and other transfers of value provided to healthcare professionals and entities.

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

We are also required to report certain ownership or investment interests held by physicians and their immediate family members.

In 2018, the law was amended to require tracking and reporting of payments and transfers of value provided to health care practitioners besides physicians, including physician assistants, nurse practitioners, and other mid-level practitioners.

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 $1.15 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.

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.

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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.

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

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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.

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 (EU-U.S.

Data Privacy Framework) may be put in place in the near future, 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.

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.

Environmental Regulation

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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 Stark Law, the federal Anti-Kickback Statute, and their state law equivalents.

Due to this scrutiny, we incur legal and consulting fees to ensure our relationships with physicians meet regulatory requirements, including that compensation paid to such physicians is within fair market value.

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.

Due to this scrutiny, we incur legal and consulting fees to ensure our relationships with physicians and other health care providers meet regulatory requirements, including that compensation paid to such physicians is within fair market value.

Human Capital

As of December 31, 2021, we have approximately 6,300 full-time employees and approximately 700 contract and temporary employees around the globe.

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.

2022 represented a year of 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.

As of December 31, 2022, we have approximately 7,600 employees around the globe, including 7,500 full-time employees.

Approximately 60% of our full-time U.S.

employees are ethnically diverse.

Country Female Male Grand Total Ethnically Diverse

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

None of our employees are represented by a labor union or covered by a collective bargaining agreement, except for our employees in our Mainz, Germany location that are represented by a Works Council.

We have never experienced any employment-related work stoppages and we consider our employee relations to be good.

We are optimistic about the potential to expand our global workforce and create a more inclusive environment for all of our employees.

**Includes full time and part time employees.

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

communications and engagement;

health, safety and wellness;

total rewards and pay equity;

and talent growth and development.

Diversity, Equity and Inclusion

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

We are proud of the additional ground we have gained in 2021 to advance our efforts and the external recognition received in Forbes magazine, landing on its Best Employers for Women , Best Employers for Diversity and Best in State Employer lists for the U.S.

offices, and the Investors In People Silver Certification awarded to our Dexcom Philippines office.

We established diversity, equity, and inclusion, or DEI, as a corporate objective under our 2021 corporate goal related to the employee experience and commitment.

As Dexcom continues to grow and scale, 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.

With expanded talent and diversity staff, we have evolved the DEI Leadership Council, or DLC, as a means for leaders to work closely together to advance the broader DEI strategy across the organization.

We have also added several more employee resource groups for our employees globally.

In 2021, we launched an interactive foundational training program on DEI for our managers, in each of Dexcom’s global locations.

To date, more than 70% of our global people leaders have completed this optional training.

In 2022, foundational DEI training will launch to all employees.

To continue to foster equity through our core talent processes, we rolled out a diversity snapshot data tool for our people leaders to establish a baseline understanding of the diversity of their teams and measure the effectiveness of DEI practices over time.

Our annual talent planning reviews have evolved to include discussion of function-specific DEI strengths and opportunities throughout each team.

In 2022, we plan to launch two pipeline development programs--one specifically aimed at developing top-performing diverse managers, and the other focused on fostering a diverse leadership pipeline.

In 2021, our company internship program doubled the number of women and ethnically diverse participants.

Ethnically diverse students accounted for nearly half of our 2021 internship class.

Our annual employee experience survey included a DEI index to help track our efforts on diversity, equity, inclusion, accessibility and belonging, which was favorable across all questions.The work we have done to date represents the beginning of our DEI journey.

We will continue to focus on building a pipeline of opportunities for both the hiring and advancement of qualified individuals, including for women, persons with disabilities, and minority groups that are underrepresented in science and engineering industries.

We believe that diverse perspectives will help empower our employees, patients and industry.

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.

In 2022, foundational DEI training was launched to all employees.

We also offered opportunities for employees to take a deeper dive into specific topics related to DEI.

2022 also allowed us to build out our talent programs to foster equitable access and visibility to our up-and-coming diverse leaders within the company.

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.

Communications and Engagement

Our success depends on employees understanding our strategic vision as well as our day-to-day objectives.

To that end, we employ a mix of communication and engagement channels, including a global intranet and social network, and global

regional and functional town halls;

regular leadership forums;

and quarterly updates on our progress against our strategic goals.

We have also deployed digital signage into our manufacturing and distribution areas to ensure that all our onsite employees remain connected to our mission and goals.

In addition, we have a cross-functional team that focuses on improving the employee experience and driving engagement.

A central part of our communications and engagement efforts are connecting people to purpose.

To this end, we regularly invite Dexcom users, called Warriors, to share their stories with our employees.

Whether the Warrior is a professional athlete whose performance depends on Dexcom, or a parent who no longer has to stick their child’s fingers during the night, their experiences reinforce our commitment to expand our reach into new patient populations, geographies and markets.

We value every employee’s unique characteristics, contributions, and perspectives.

In 2021, we launched a listening strategy across multiple points of the employee experience and engaged employees in co-creating our human-centered hybrid workplace and employee experience through their feedback.

As the COVID-19 pandemic continued to produce unpredictability and anxiety, we encouraged our leaders to check in frequently to gauge the well-being of their teams.

We surveyed employee perspectives and expectations about returning to the workplace and continued to provide resources and support to drive productivity and connection as returns to the office were further delayed for many teams.

Our leadership defined a Dexcom-specific employee experience vision, against which we developed an employee engagement survey to measure our current state.

Our survey had more than 80% participation rate.

While employees in large part responded favorably, representing a positive experience and strong engagement, the feedback employees provided informs our action planning related to areas of opportunity, as we continue to evolve toward a world-class employee experience for our organization.

Through strategic communications, we have strengthened the connection between our leaders and our business goals, as well as the behaviors needed to drive our employee experience.

We also believe by listening to our employees, we can create a dynamic workplace that will foster productivity while promoting work-life balance and connection across the organization.

We have continued to seek out “the voice of the employee” through life cycle surveys.

Each year, we offer an engagement survey titled “We’re Listening.” Employee engagement scores remain high based on index and remains consistent at approximately 80% since November 2021.

What is notable is people are proud to work here and see a clear link between their work and the Dexcom mission.

Health, Safety and Wellness

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We also provide comprehensive well-being programs that support our employees and their families.

For example, Inspire, our newly launched global wellness platform, helps employees and their family members develop and achieve their physical, emotional, and financial well-being goals.

In 2021, to support our employees’ continued needs related to the COVID-19 pandemic, we provided multiple vaccination clinics for employees and their families, proactive on-site testing for our employees who returned to the workplace, and continued support of remote work for employees whose roles allow for it.

For example, Inspire, our global wellness platform, helps employees and their family members develop and achieve their physical, emotional, and financial well-being goals.

We offer our employees the choice of several health plans including the Level2 program, which is designed specifically to support individuals with type 2 diabetes, and provides participants a Dexcom CGM, an activity tracker, and ongoing coaching to encourage greater health outcomes.

As the COVID-19 pandemic continued in 2022, our goal to support our employees’ needs remained constant.

We continued to provide both COVID and flu vaccination clinics for employees and their families, proactive on-site testing for our employees who returned to the workplace, 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 recognize that our employees are our most valuable asset.

Total Rewards and Pay Equity

Our total rewards package includes market competitive pay, comprehensive and competitive global benefits and retirement offerings, paid time off and family leave, tuition reimbursement and on-site services.

To foster a stronger sense of ownership and align the interests of employees with shareholders, we offer an Employee Stock Purchase Plan, and restricted stock units are provided to eligible employees under our broad-based stock incentive programs.

In 2021, we decided to implement a proactive year-end global market adjustment process intended to ensure we maintain pay equity between active employees and potential new external hires.

In 2022, we continued our proactive year-end global market adjustment process intended to ensure we maintain pay equity between active employees and potential new external hires.

Through this process, employees who meet predefined criteria may be eligible for an additional adjustment in base salary if they have fallen below Dexcom’s determined minimum.

During this first review we made proactive adjustments in pay to approximately 10% of Dexcom’s global employees.

We believe by continuing to ensure equitable pay between existing and new hires, we will be better positioned to retain valued employees.

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With the implementation of our global market adjustment process, we will now conduct the gender and ethnicity review twice a year.

Growth and Development

We value the talented and passionate individuals working at Dexcom and the culture we collectively create.

To support their growth and drive their continued success, we continue to expand our portfolio of development offerings and empower employees and leaders alike to dedicate time to honing their craft.

Because there is no one-size-fits-all approach to developing the skills and knowledge needed to be successful, we continue to evaluate and evolve our learning delivery to meet the needs of our workforce.

We continue to use industry research and feedback from our employees to ensure we provide opportunities for development and growth for employees at all levels across Dexcom.

As we continue to function as a hybrid workplace, we will continue to invest in talent and technology to offer the learning experiences needed to grow and develop critical skills across the organization, regardless of level or location.

Talent Growth and Development

We continue to invest in new learning systems and programming to support employee development.

To support the personal and professional growth of our workforce, we have built an extensive library of development offerings to empower employees at all levels to advance their skill sets and knowledge base.

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 32,000 hours dedicated to this learning.

In addition, each employee has unlimited access to LinkedIn Learning, which offers more than 13,000 courses designed to support career advancement.

In 2022, more than one-third of our employees used LinkedIn Learning to assist in their professional development.

We increased the utilization of this platform in 2022 by embedding videos and courses in learning initiatives, encouraging leader and peer recommendations, and using targeted marketing of this resource throughout the organization.

This has resulted in our employees completing over 14,000 courses in 2022.

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What changed 10-K

Item 1. Business