ITEM 1 - BUSINESS
−Removed: We are a medical device company primarily focused on the design, development and commercialization of continuous glucose monitoring, or CGM, systems for use by people with diabetes and by healthcare providers.
−Removed: We received approval from the United States Food and Drug Administration, or FDA, and commercialized our first product in 2006.
−Removed: 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.
+Added: We are a medical device company primarily focused on the design, development and commercialization of continuous glucose monitoring, or CGM, systems for the management of diabetes by patients, caregivers, and clinicians around the world.
+Added: We received approval from the Food and Drug Administration, or FDA, and commercialized our first product in 2006.
+Added: We launched our latest generation systems, the Dexcom G6 ® integrated Continuous Glucose Monitoring System, or G6, in 2018 and more recently received marketing clearance from the FDA on the Dexcom G7 ® , or G7, in December 2022.
Unless the context requires otherwise, the terms “we,” “us,” “our,” the “company,” or “Dexcom” refer to DexCom, Inc.
and its subsidiaries.
−Removed: The mailing address of our headquarters is 6340 Sequence Drive, San Diego, California, 92121 and our telephone number at that location is (858) 200-0200.
−Removed: Our Internet website address is www.dexcom.com.
−Removed: We provide free access to various reports that we file with or furnish to the SEC through our website, as soon as reasonably practicable after they have been filed or furnished.
−Removed: These reports include, but are not limited to, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports.
−Removed: Information on our website does not constitute part of this Annual Report on Form 10-K or other report we file or furnish with the SEC.
−Removed: The reports are also available at www.sec.gov.
−Removed: Also available on our website are printable versions of our Audit Committee charter, Compensation Committee charter, Nominating and Corporate Governance Committee charter, Technology Committee charter, Corporate Governance Guidelines and Code of Conduct and Business Ethics.
−Removed: Stockholders may request copies of these documents by mail or telephone, at the address or phone number provided above.
In March 2018, we obtained marketing authorization from the FDA for the G6 via the de novo process.
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Our receiver is also reusable.
−Removed: As we 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.
+Added: 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:
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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.
−Removed: We are working to obtain reimbursement coverage by Medicare and Medicaid and by commercial insurers in the United States.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: 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:
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Since the G7 is classified by the FDA as a Class II device, it is subject to special controls and modifications of, or revisions to, the device may be made under the 510(k) process.
+Added: Dexcom Stelo ®
+Added: We are pursuing regulatory approvals for Dexcom Stelo, our first product designed specifically for people with type 2 diabetes who do not use insulin and are not at risk for hypoglycemia.
+Added: Stelo was submitted for FDA review in the fourth quarter of 2023.
Dexcom Share ®
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Like our other CGM systems, Dexcom ONE is designed to replace finger stick blood glucose testing for diabetes treatment decisions.
+Added: In November 2023, we obtained CE Mark approval for Dexcom ONE+.
+Added: 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.
Data and Insulin Delivery Collaborations
We have entered into multiple collaboration agreements that leverage our technology platform to integrate our CGM products with insulin delivery systems.
−Removed: 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
−Removed: some cases, use the glucose readings for semi-automated insulin delivery.
−Removed: Currently, we have announced significant insulin delivery partnerships with Eli Lilly, Insulet, Novo Nordisk, Tandem Diabetes and The Ypsomed Group.
−Removed: In addition to these major partners, we are working with other companies that are pursuing varying strategies surrounding semi-automated insulin delivery and data analytics to improve outcomes and ease-of-use in diabetes management.
+Added: The general purpose of these development and commercial relationships is
+Added: 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.
+Added: We have existing insulin delivery partnerships, and we are also working with other companies that are pursuing varying strategies surrounding semi-automated insulin delivery and data analytics to improve outcomes and ease-of-use in diabetes management.
We have also entered into collaborations with several organizations that are currently using, or are developing, programs for the treatment of Type 2 diabetes that utilize our current CGM systems.
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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.
−Removed: 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.
+Added: In consideration of Verily’s performance of its obligations under the joint development plan of the Restated Collaboration Agreement, the licenses granted to us and the amendment of the original agreement, we have made upfront, incentive, product regulatory approval milestone payments, and a sales-based milestone payment.
+Added: In the future, we may make a potential additional milestone payment for a future sales-based milestone.
At our election, we may make these payments in shares of our common stock or cash.
−Removed: 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.
−Removed: We intend to pay the sales-based contingent milestones in shares of our common stock.
−Removed: 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.
+Added: If we elect to make a milestone payment in cash, any such cash payment would be equal to the number of shares that would otherwise be issued for the given milestone payment multiplied by the value of our stock on the date the relevant milestone is achieved, adjusted for stock splits, dividends, and the like.
+Added: We intend to pay the remaining sales-based contingent milestone in shares of our common stock.
+Added: See Note 2 “Development and Other Agreements” to the consolidated financial statements in Part II, Item 8 of this Annual Report and Exhibit 10.14 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 Centers for Disease Control and Prevention, or CDC, in its National Diabetes Statistics Report, 2023, or the 2023 CDC Report, crude estimates for the prevalence of diabetes in the United States as of 2021 include 38.4 million people with diabetes, of which 29.7 million people have diagnosed diabetes.
−Removed: The 2022 CDC Report also lists diabetes as the seventh leading cause of death by disease in the United States, excluding comorbidities associated with the disease.
−Removed: The report states that diabetes is the primary cause of death for more than 87,000 Americans each year, and contributes to the death of more than 280,000 Americans annually.
−Removed: According to the Congressional Diabetes Caucus website, diabetes is the leading cause of kidney failure, adult-onset blindness, lower-limb amputations, and a significant cause of heart disease, stroke, high blood pressure and nerve damage.
−Removed: 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.
−Removed: 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.
+Added: According to the American Diabetes Association, or ADA, one in every four healthcare dollars
+Added: was spent on treating people with diabetes in 2022, and the direct medical costs and indirect expenditures attributable to diabetes in the United States were an estimated $413 billion, an inflation-adjusted increase of approximately 35% since 2012.
Of the $413 billion in overall expenses, the ADA estimated that approximately $307 billion were direct costs associated with diabetes care, chronic complications and excess general medical costs, and $106 billion were indirect costs.
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Individuals with Type 1 diabetes must rely on frequent insulin injections in order to regulate and maintain blood glucose levels.
−Removed: According to JDRF, greater than 60,000 people are diagnosed with Type 1 diabetes each year in the United States.
−Removed: 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.
Type 2 Diabetes
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The study also demonstrated that people with Type 1 diabetes achieved sustained benefits with intensive management.
−Removed: However, according to an article published in The New England Journal of Medicine in November 2014, in two national registries, only 13% to 15% of people with diabetes met treatment guidelines for good glycemic control, and more than 20% had very poor glycemic control.
Various clinical studies and real-world evidence also demonstrate the benefits of continuous glucose monitoring in the management of Type 1 diabetes and insulin-requiring Type-2 diabetes, when compared to regimens relying on self-monitoring of blood glucose.
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Real-time alerts and multi-device integration further differentiate CGM-based and self-monitoring of blood glucose, or SMBG, based diabetes regimens.
−Removed: Alerts triggered by existing or impending abnormal glucose values are associated with less exposure to hypo- and hyperglycemia in large real-world data sets, and multi-device integration allows some CGM systems to communicate with automated insulin delivery systems.
+Added: Alerts triggered by existing or impending abnormal glucose values are associated with less exposure to hypo- and hyperglycemia in large real-world data sets, and multi-device integration
+Added: allows some CGM systems to communicate with automated insulin delivery systems.
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.
−Removed: Our current target market consists primarily of people with Type 1 and Type 2 diabetes who utilize insulin therapy.
−Removed: 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.
+Added: Our current target market consists primarily of people with Type 1 and Type 2 diabetes who utilize insulin therapy as well as certain non-insulin using people with diabetes that struggle with hypoglycemia.
+Added: 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 or have hypoglycemia risk, a group that we estimate to be greater than 25 million people in the United States alone.
We are extending our commercial efforts for this population through several channels, including through strategic partnerships.
−Removed: 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.
+Added: In the future, we plan to expand our product offering to people who are pregnant and cleared/approved indications to address people with pre-diabetes, people who are obese, 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 additional markets in North America, Africa, Asia Pacific, Europe, Latin America and the Middle East.
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• Supporting use of our ambulatory products through a direct sales and marketing effort, as well as key distribution arrangements.
−Removed: • 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.
+Added: • Supporting innovation through technology integration partnerships.
• Seeking broad coverage policies and reimbursement for our products from private third-party payors and national health systems.
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Receiver and Transmitter Technology
−Removed: Our current CGM systems wirelessly transmit information from the transmitter, which sits in a pod atop the sensor, to our receiver or to a compatible mobile device.
+Added: Our current CGM systems wirelessly transmit information from the transmitter to our receiver or to a compatible mobile device.
We have developed technology for reliable transmission and reception and have consistently demonstrated a high rate of successful transmissions from transmitter to receiver or compatible mobile device in our clinical trials.
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We have used our extensive database of continuous glucose data to create and refine software, algorithms and other technology for the display of data to customers.
−Removed: Disposable Sensor and Reusable Transmitter
−Removed: Our sensor includes a tiny wire-like electrode coated with our sensing membrane system.
−Removed: This disposable sensor comes packaged with an integrated insertion device and is contained in a small plastic housing platform, or pod.
−Removed: The base of the pod has adhesive that attaches it to the skin.
−Removed: The sensor is intended to be easily and reliably inserted by the user by exposing the adhesive, placing the pod against the surface of the skin of the abdomen or upper buttocks for people ages 2-17, and pushing down on the insertion device.
−Removed: The insertion device first extends a narrow gauge needle containing the sensor into the subcutaneous tissue and then retracts the needle, leaving behind the sensor in the tissue and the pod adhered to the skin.
−Removed: The user then disposes of the insertion device and snaps the transmitter to the pod.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: To replace a sensor, the user simply removes the pod and attached sensor from the skin and discards them while retaining the reusable transmitter.
−Removed: A new sensor and pod can then be inserted and used with the same receiver and transmitter for a subsequent use period.
−Removed: Handheld Receiver
−Removed: Our small handheld receiver is carried by the user and wirelessly receives continuous glucose values from the transmitter.
−Removed: 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.
−Removed: 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.
−Removed: Additionally, when glucose values are inappropriately high or low, the receiver provides an audible alert or vibrates.
−Removed: The receiver is a self-contained, durable unit with a rechargeable battery.
Compatible Mobile Devices
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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.
−Removed: We plan to develop future generations of technologies focused on improved performance and convenience that will enable intelligent insulin administration.
+Added: We plan to develop future generations of technologies that are focused on improved performance and convenience and 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.
−Removed: 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.
+Added: 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 continue to pursue and support development partnerships with insulin pump companies and companies or institutions developing insulin delivery systems, including automated insulin delivery systems.
−Removed: We are also exploring how to extend our offerings to other populations, including for people with Type 2 diabetes that are non-insulin using, people with pre-diabetes, people who are obese, people who are pregnant, and people in the hospital setting.
+Added: We are also exploring how to extend our offerings to other opportunities, including for people with Type 2 diabetes that are non-insulin using, people with pre-diabetes, people who are obese, people who are pregnant, and people in the hospital setting.
Eventually, we may apply our technological expertise to products beyond glucose monitoring.
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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.
−Removed: 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
−Removed: professionals and patients are knowledgeable about our products and their functionality.
+Added: 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.
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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.
−Removed: In jurisdictions where DTC marketing is permitted, we currently focus on reaching people with Type 1 and insulin intensive Type 2 diabetes.
+Added: In jurisdictions where DTC marketing is permitted, we currently focus on reaching people with Type 1 and people with Type 2 diabetes who use insulin.
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.
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We have competed with Abbott and their Libre family of CGM products for many years.
−Removed: Medtronic markets and sells a standalone glucose monitoring product called Guardian Connect, both internationally and in the United States.
+Added: 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.
+Added: Likewise, Abbott Diabetes Care has
+Added: received FDA clearance to integrate certain versions of their Libre sensors into automated insulin delivery systems and is pursuing such integrations with third-party insulin delivery devices.
We are also aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for the general health and wellness, or population health space.
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Manufacturing
−Removed: 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.
−Removed: 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.
−Removed: There are technical challenges to increasing manufacturing capacity, finding or enhancing new manufacturing facilities capable of meeting regulatory requirements, U.S.
−Removed: state licensure of manufacturing facilities, equipment design and automation, material procurement, problems with production yields, and quality control and assurance.
+Added: 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 65,900 square feet of laboratory space and approximately 155,700 square feet of controlled environment rooms.
+Added: In 2023, we completed the initial phase of construction of our new facility in Malaysia and commenced commercial manufacturing.
+Added: We are also expanding our facility in Mesa, Arizona to scale up manufacturing capacity and plan to begin construction of a new facility in Ireland.
+Added: We anticipate that the new facilities and the Mesa capacity scale-up will add substantial manufacturing capacity.
+Added: There are technical challenges to increasing manufacturing capacity, finding or enhancing new manufacturing facilities capable of meeting regulatory requirements, government licensure of manufacturing facilities, equipment design and automation, material procurement, problems with production yields, and quality control and assurance.
We have focused significant effort on continual improvement programs in our manufacturing operations intended to improve quality, yields and throughput.
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As of December 31, 2023, 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.
−Removed: 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 .”
+Added: 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 .”
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.
−Removed: 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.
−Removed: 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.
−Removed: We also have coverage under certain international markets and Medicaid coverage in about 45 states.
+Added: Medicare covers the CGM system, which includes supplies necessary for the use of the device, under the Durable Medical Equipment, or DME, benefit category.
+Added: 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.
+Added: The Local Coverage Determination, or LCD, that the Centers for Medicare & Medicaid Services released in April 2023 extends Medicare CGM coverage to all patients using insulin.
+Added: Further, the LCD also allows coverage for patients not taking insulin if the patient has a history of problematic hypoglycemia.
+Added: We also have coverage under certain international markets and Medicaid coverage in approximately 45 states.
As of December 31, 2023, the eight largest private third-party payors, in terms of the number of covered lives, have issued coverage policies for the category of continuous glucose monitoring devices.
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.
−Removed: We have personnel with reimbursement expertise to assist customers in obtaining reimbursement from
−Removed: private third-party payors.
+Added: 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.
We have continued our efforts to create and liberalize coverage policies with third-party payors, including obtaining reimbursement for our products under pharmacy benefits and for more people with diabetes.
−Removed: For additional information on third-party reimbursement, please see our see Risk Factors entitled “ Managed care trends and consolidation in the health care industry could have an adverse effect on our revenues and results of operations.” and “ Health care policy changes, including U.S.
−Removed: health care reform legislation, may have a material adverse effect on our business .”
+Added: For additional information on third-party reimbursement, please see our see Risk Factors in the section entitled “ Risks Related to Pricing and Reimbursement .”
Intellectual Property
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Third parties may also independently develop similar or competing technology that avoids our patents.
−Removed: The steps we have taken may not prevent the misappropriation of our intellectual property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the United States.
+Added: The steps we have taken may not prevent the misappropriation of our intellectual property, particularly in international countries where the laws may not protect our proprietary rights as fully as in the United States.
We also face risks associated with intellectual property infringement.
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We also generally require confidentiality or material transfer agreements from third parties that receive our confidential data or materials.
−Removed: We cannot guarantee that employees and third parties will abide by the confidentiality or assignment terms of these agreements.
+Added: We cannot guarantee that employees and third parties will abide by the confidentiality
+Added: or assignment terms of these agreements.
Despite measures taken to protect our intellectual property, unauthorized parties might copy aspects of our products or obtain and use information that we regard as proprietary.
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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.
−Removed: In addition, we promote diversity, practice fairness, and treat everyone with respect and dignity.
+Added: 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.
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We also maintain a compliance program to help enforce ethical conduct and adherence to applicable laws and regulations.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: The Nominating and Governance Committee of the Board of Directors oversees and reviews Dexcom’s risks, opportunities, strategies, programs, policies, practices, measures, objectives and performance relating to corporate sustainability matters.
+Added: Our management-level Corporate Sustainability Steering Committee, which is comprised of the functional leads from our Commercial, Operations, Human Capital, Finance and Legal departments, is responsible for, among other things, setting the overall strategy with respect to corporate sustainability matters (subject to direction from the Chief Executive Officer and oversight of the Nominating and Governance Committee), establishing programs, policies and practices relating to corporate sustainability matters (“Dexcom’s Corporate Sustainability Program”) and overseeing and monitoring the implementation of Dexcom’s Corporate Sustainability Program.
+Added: The Corporate Sustainability Steering Committee reports to our Chief Executive Officer and provides periodic updates regarding our corporate sustainability programs, policies and practices to the Nominating and Governance Committee of our Board of Directors.
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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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.
−Removed: Class II devices are subject to special controls such as performance standards, post-market
−Removed: surveillance, FDA guidelines, or particularized labeling, as well as general controls.
+Added: 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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A PMA application also must include a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling.
−Removed: FDA review of a PMA application generally takes between one and three years, but may take significantly longer.
−Removed: The FDA can delay, limit or deny approval of a PMA application for many reasons.
−Removed: If an FDA evaluation of a PMA application or manufacturing facilities is favorable, the FDA will either issue an approval letter, or approvable letter, which usually contains a number of conditions which must be met in order to secure final approval of the PMA.
−Removed: When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of a device, subject to the conditions of approval and the limitations established in the approval letter.
−Removed: If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.
−Removed: The FDA may also determine that additional trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA.
−Removed: The PMA process can be expensive, uncertain and lengthy and a number of devices for which FDA approval has been sought by other companies have never been approved by the FDA for marketing.
−Removed: New PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling, device specifications, materials or design of a device that is approved through the PMA process.
−Removed: PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA application and may or may not require as extensive clinical data or the convening of an advisory panel.
−Removed: Clinical trials are almost always required to support a PMA application and are sometimes required for a 510(k) clearance.
−Removed: All clinical trials must be conducted in accordance with the FDA’s IDE regulations, which govern investigational device labeling, prohibit promotion, and specify an array of Good Clinical Practice requirements, which include among other things, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
−Removed: Clinical trials must further comply with the FDA’s regulations for institutional review board approval and for informed consent and other human subject protections.
−Removed: Required records and reports are subject to inspection by the FDA.
−Removed: The results of clinical testing may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product.
−Removed: The commencement or completion of any of our clinical trials may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous reasons, including, but not limited to, the following:
−Removed: • the FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;
−Removed: • patients do not enroll in clinical trials at the rate we expect;
−Removed: • patients do not comply with trial protocols;
−Removed: • patient follow-up is not at the rate we expect;
−Removed: • patients experience adverse side effects;
−Removed: • patients die during a clinical trial, even though their death may not be related to our products;
−Removed: • institutional review boards and third-party clinical investigators may delay or reject our trial protocol;
−Removed: • third-party clinical investigators decline to participate in a trial or do not perform a trial on our anticipated schedule or consistent with the clinical trial protocol, good clinical practices or other FDA requirements;
−Removed: • Dexcom or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol or investigational or statistical plans;
−Removed: • third-party clinical investigators have significant financial interests related to Dexcom or the study that the FDA deems to make the study results unreliable, or Dexcom or investigators fail to disclose such interests;
−Removed: • 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;
−Removed: • 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;
−Removed: • the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness;
−Removed: • the FDA concludes that the results from our trial and/or trial design are inadequate to demonstrate safety and effectiveness of the product.
In addition to our CGM device, we have a Class I data management service which we market to clinics.
16 unchanged sentences
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.
−Removed: The FDA and the Food and Drug Branch of the California Department of Health Services enforce regulatory requirements by conducting
−Removed: periodic, unannounced inspections and market surveillance.
+Added: The FDA and the Food and Drug Branch of the California Department of Health Services and other applicable government regulatory agencies enforce regulatory requirements by conducting periodic, unannounced inspections and market surveillance.
Inspections may include the manufacturing facilities of our subcontractors.
23 unchanged sentences
Anti-kickback Laws.
−Removed: 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.
+Added: 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
+Added: 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.
6 unchanged sentences
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.
−Removed: When an entity is determined to have violated the False Claims Act, it may
−Removed: be subject to repayment of three times the actual damages sustained by the government, plus significant mandatory civil penalties for each separate false claim.
+Added: 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.
19 unchanged sentences
Civil Monetary Penalties Law .
−Removed: 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.
+Added: 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
+Added: Inducement CMP.
Remuneration is defined under the CMPL as any transfer of items or services for free or for less than fair market value.
9 unchanged sentences
healthcare fraud and false statements relating to healthcare matters.
−Removed: The healthcare fraud statute prohibits knowingly and willfully executing a scheme to
−Removed: defraud any healthcare benefit program, including private payors.
−Removed: A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs.
+Added: The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private payors.
+Added: A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government sponsored programs, or integrity oversight and reporting obligations to resolve allegations of non-compliance.
The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
1 unchanged sentence
Privacy Laws and Regulations.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Numerous federal and state laws, rules and regulations govern the collection, dissemination, use, privacy, security and confidentiality of personal information.
+Added: HIPAA, in addition to the criminal powers above, extensively regulates the use and disclosure of individually identifiable health information, through the Privacy, Security, and Breach Notification Rules.
+Added: HIPAA requires covered entities, including health plans and most health care providers, to implement administrative, physical and technical safeguards to protect the privacy and security of covered information (known as “protected health information”) and sets limits and conditions on the uses and disclosures that may be made of such information without the authorization of the relevant individual.
+Added: 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.
1 unchanged sentence
Department of Health & Human Services, Office for Civil Rights (OCR) and, in certain situations involving large breaches, to the media.
−Removed: 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.
−Removed: The OCR enforces the HIPAA regulations and performs compliance audits.
+Added: The OCR enforces the HIPAA Rules and performs compliance audits and investigations.
+Added: In addition to enforcement by OCR, HIPAA authorizes state attorneys general to bring civil actions seeking either injunction or damages in response to HIPAA violations that impact state residents.
On December 1, 2022, OCR issued a bulletin on the requirements under HIPAA for online tracking technologies (e.g., cookies, pixels) to protect the privacy and security of health information.
−Removed: 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.
−Removed: 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.
−Removed: Dexcom is a covered entity under HIPAA and in certain circumstances may also be a business associate of another covered entity.
−Removed: The HIPAA privacy regulations and security regulations impose and will continue to impose significant costs on us in order to comply with these standards.
−Removed: There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns.
−Removed: 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.
+Added: This bulletin outlined OCR’s position on the use of online tracking technology vendors, when certain information received by such vendors constitutes protected health information under HIPAA, and accordingly, when business associate agreements must be executed between covered entities, like us, and such vendors.
+Added: We are a covered entity under HIPAA because we are a health care provider that engages in certain electronic standard transactions.
+Added: In certain circumstances, we may also be a business associate of another covered entity or of another business associate.
+Added: We have assessed our responsibilities under the bulletin and undertaken a number of initiatives to support our compliance with HIPAA and other requirements relating to online tracking technologies, including updates to our cookie banners and preference center.
+Added: These steps are in addition to measures we had taken previously and we continue to evaluate our compliance with applicable laws and adjust our practices to address developments in the field over time.
+Added: The HIPAA Rules impose and will continue to impose significant costs on us in order to comply with these standards.
+Added: There are numerous other laws, regulations and legislative and regulatory initiatives at the federal and state levels addressing privacy and security of personal information.
+Added: We also remain subject to federal and state privacy-related laws that may be more restrictive or contain different requirements than the privacy regulations issued under HIPAA.
These laws vary and could impose additional penalties.
−Removed: For example, the Federal Trade Commission uses its consumer protection authority to initiate enforcement actions in response to alleged privacy and data security violations.
+Added: For example, the Federal Trade Commission, or FTC, uses its consumer protection authority to initiate enforcement actions against companies relating to their use and
+Added: disclosure of personally identifiable information.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: 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;
+Added: 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;
−Removed: and the Utah Consumer Privacy Act, effective as of December 31, 2023.
+Added: the Utah Consumer Privacy Act, effective as of December 31, 2023;
+Added: the Washington My Health My Data Act and Nevada Senate Bill 370, both effective as of March 31, 2024;
+Added: 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;
+Added: the Montana Consumer Data Privacy Act, effective as of October 1, 2024;
+Added: the Delaware Personal Data Privacy Act, effective as of January 1, 2025;
+Added: the Iowa Act Relating to Consumer Data Protection, effective as of January 1, 2025;
+Added: the Tennessee Information Protection Act, effective as of July 1, 2025;
+Added: and the Indiana Consumer Data Protection Act, effective as of January 1, 2026.
+Added: Several other states have enacted, or 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: Regulations implementing the California and Colorado laws have been published (in draft form for California, and final form for Colorado), but many questions remain as to how all of the new statutes will be interpreted and enforced.
+Added: The effects of state data protection laws are significant and have required us to modify our data processing practices.
+Added: They may also cause us to incur substantial costs and expenses to ensure ongoing compliance, particularly given our base of operations in California.
+Added: 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.
+Added: In addition to the laws discussed above, we may see more stringent state and federal privacy legislation passed in 2024 and beyond, as the increased cyber-attacks during recent international conflicts have once again put a spotlight on data privacy and security in the U.S.
and other jurisdictions.
3 unchanged sentences
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.
−Removed: The scope of the FCPA would include interactions with certain healthcare
−Removed: professionals in many countries, either directly or through our contracted distributors.
+Added: 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.
11 unchanged sentences
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.
−Removed: Certain states also mandate that device manufacturers implement compliance programs.
+Added: Certain states also
+Added: mandate that device manufacturers implement compliance programs.
Other states impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation, and other remuneration to healthcare professionals and entities.
4 unchanged sentences
There is a trend towards harmonization of quality system standards among the European Union, United States, Canada and various other industrialized countries.
−Removed: The regulatory framework governing medical devices is largely harmonized within the European Union, which includes most of the major countries in Europe (please note that the UK is effectively no longer part of the European Union as of January 1, 2021).
+Added: 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.
3 unchanged sentences
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.
−Removed: The European Union Medical Device Regulation, or MDR, went into force in 2017, replacing the existing Directive and providing three years for transition and compliance, which has been extended by one additional year.
+Added: The European Union Medical Device Regulation, or MDR, went into force in 2017, and replaced the existing Directive.
+Added: 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.
4 unchanged sentences
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.
−Removed: MedTech Europe, the medical device industry association, also
−Removed: introduced the Code of Ethical Business Practices, which came into effect on January 1, 2017.
+Added: 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.
8 unchanged sentences
Privacy Shield Framework invalid (Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems, also knowns as “Schrems II”).
−Removed: 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.
−Removed: Though a new adequacy decision (EU-U.S.
−Removed: 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.
+Added: 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
+Added: data outside of Europe.
+Added: Though a new adequacy decision (the EU-U.S.
+Added: Data Privacy Framework) has been adopted, and 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.
26 unchanged sentences
United States 2,600 3,200 5,800 3,700
−Removed: Non-United States (“OUS”) 1,300 1,100 2,400 N/A
+Added: International
+Added: 2,100 1,700 3,800 N/A
Grand Total** 4,700 4,900 9,600 3,700
10 unchanged sentences
Our journey to create a more diverse, equitable and inclusive workplace continues.
−Removed: 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.
−Removed: 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.
+Added: As Dexcom continues to grow and scale, we believe our DEI initiatives have been critical not only for company culture but also for the growing diversity of patients our products will benefit across the globe.
+Added: Our talent and diversity staff and the DEI Leadership Council, or DLC, are a means for leaders to work closely together to advance the broader DEI strategy across the organization.
We are proud to support our global and local employee resource groups, whose employee-led activities and initiatives we believe continue to foster a sense of belonging for our employees.
−Removed: In 2022, foundational DEI training was launched to all employees.
−Removed: We also offered opportunities for employees to take a deeper dive into specific topics related to DEI.
−Removed: 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
−Removed: 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.
+Added: Through strategic communications, we continue to strengthen the connection between our leaders and our business goals, as well as the behaviors needed to drive a positive 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.
−Removed: 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.
−Removed: What is notable is people are proud to work here and see a clear link between their work and the Dexcom mission.
+Added: Each year, we offer an engagement survey titled “We’re Listening.” Employee engagement scores consistently remained high based on a six-factor index.
+Added: Notably, a strong majority of employees indicated they are proud to work for Dexcom and see a clear link between their work and the Dexcom mission.
Health, Safety and Wellness
2 unchanged sentences
Through these efforts, along with leadership commitment and investment of resources in support of workplace safety initiatives, our total US injury rate has consistently tracked below industry averages.
−Removed: We also provide comprehensive well-being programs that support our employees and their families.
−Removed: For example, Inspire, our global wellness platform, helps employees and their family members develop and achieve their physical, emotional, and financial well-being goals.
−Removed: 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.
−Removed: As the COVID-19 pandemic continued in 2022, our goal to support our employees’ needs remained constant.
−Removed: 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.
+Added: We also provide comprehensive health and well-being programs that support our employees and their families.
+Added: For example, Inspire, our global wellness program, and our global mental health and employee assistance programs are designed to help employees and their family members develop and achieve their physical, emotional, and financial well-being goals.
+Added: Our goal to support our employees’ needs remains constant.
+Added: 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.
8 unchanged sentences
We have incorporated the findings into our compensation assessment cycles, and we recognize the need to regularly review pay equity to maintain our pay equity goals.
−Removed: With the implementation of our global market adjustment process, we will now conduct the gender and ethnicity review twice a year.
+Added: With the implementation of our global market adjustment process, we conduct the gender and ethnicity review annually.
+Added: Additionally, in 2023 we identified and engaged a third party consultant to help further evolve our gender and ethnicity pay equity review.
Talent Growth and Development
3 unchanged sentences
At this time, our employees have completed over 40,000 hours dedicated to this learning.
−Removed: In addition, each employee has unlimited access to LinkedIn Learning, which offers more than 13,000 courses designed to support career advancement.
−Removed: In 2022, more than one-third of our employees used LinkedIn Learning to assist in their professional development.
−Removed: 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.
−Removed: This has resulted in our employees completing over 14,000 courses in 2022.
+Added: Additional details regarding our human capital and other matters can be found in our Sustainability Report.
+Added: Although not incorporated by reference into this Annual Report on Form 10-K, our Sustainability Report can be accessed on our investors website at investors.dexcom.com, by clicking “Governance Documents & Sustainability”.
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.