Dexcom (DXCM) 10-K risk factor changes: FY2021 vs FY2020

[removed: For] [added: For] the fiscal year ended [removed: December] [added: December] 31, [removed: 2020][added: 2021]

[removed: ][added: ]

[removed: DEXCOM, INC.][added: | DexCom, Inc. | | |]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting [removed: company] [added: company,] or an emerging growth company.

As of June 30, [removed: 2020,] [added: 2021,] the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately [removed: $38.5] [added: $41.1] billion based on the closing sales price of [removed: $405.40] [added: $427.00] per share as reported on the Nasdaq Global Select Market.

| Class | | | | | | Outstanding at February [removed: 4, 2021] [added: 7, 2022] | | |

| Common stock, $0.001 par value per share | | | | | | [removed: 96,177,363] [added: 97,065,634] | | |

Portions of the registrant’s definitive proxy statement relating to its [removed: 2021] [added: 2022] Annual Meeting of Stockholders (the “Proxy Statement”) are incorporated by reference in Part III, Items 10 through 14 of this Annual Report on Form 10-K, as specified in the responses to those item numbers.

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| [removed: [ITEM 8.](#i889b093251984bfb881a094ef59c54bd_46)] [added: ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA] | | | [removed: [Consolidated Financial Statements and Supplementary Data](#i889b093251984bfb881a094ef59c54bd_46)] | | | [removed: [78](#i889b093251984bfb881a094ef59c54bd_46)] | | | [added: | | | | | |]

| [ITEM [removed: 9.](#i889b093251984bfb881a094ef59c54bd_49)] [added: 9.](#i15862298089b493198685c5d6204a6cb_55)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i889b093251984bfb881a094ef59c54bd_49)] [added: Disclosure](#i15862298089b493198685c5d6204a6cb_55)] | | | [removed: [79](#i889b093251984bfb881a094ef59c54bd_49)] [added: [83](#i15862298089b493198685c5d6204a6cb_55)] | | |

| [ITEM [removed: 9A.](#i889b093251984bfb881a094ef59c54bd_52)] [added: 9A.](#i15862298089b493198685c5d6204a6cb_58)] | | | [Controls and [removed: Procedures](#i889b093251984bfb881a094ef59c54bd_52)] [added: Procedures](#i15862298089b493198685c5d6204a6cb_58)] | | | [removed: [79](#i889b093251984bfb881a094ef59c54bd_52)] [added: [83](#i15862298089b493198685c5d6204a6cb_58)] | | |

| [ITEM [removed: 9B.](#i889b093251984bfb881a094ef59c54bd_55)] [added: 9B.](#i15862298089b493198685c5d6204a6cb_61)] | | | [Other [removed: Information](#i889b093251984bfb881a094ef59c54bd_55)] [added: Information](#i15862298089b493198685c5d6204a6cb_61)] | | | [removed: [81](#i889b093251984bfb881a094ef59c54bd_55)] [added: [86](#i15862298089b493198685c5d6204a6cb_61)] | | |

| [ITEM [removed: 10.](#i889b093251984bfb881a094ef59c54bd_61)] [added: 10.](#i15862298089b493198685c5d6204a6cb_67)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#i889b093251984bfb881a094ef59c54bd_61)] [added: Governance](#i15862298089b493198685c5d6204a6cb_67)] | | | [removed: [81](#i889b093251984bfb881a094ef59c54bd_61)] [added: [86](#i15862298089b493198685c5d6204a6cb_67)] | | |

| [ITEM [removed: 11.](#i889b093251984bfb881a094ef59c54bd_64)] [added: 11.](#i15862298089b493198685c5d6204a6cb_70)] | | | [Executive [removed: Compensation](#i889b093251984bfb881a094ef59c54bd_64)] [added: Compensation](#i15862298089b493198685c5d6204a6cb_70)] | | | [removed: [81](#i889b093251984bfb881a094ef59c54bd_64)] [added: [86](#i15862298089b493198685c5d6204a6cb_70)] | | |

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We received approval from the United States [removed: (U.S.)] Food and Drug Administration, or FDA, and commercialized our first product in 2006.

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

The G6 [removed: is] [added: 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.

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

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

A patient’s glucose data can also be displayed on a patient’s or follower’s wearable device, such as the Apple Watch and Wear OS by Google devices, when used in conjunction with the patient’s or follower’s [added: compatible] iPhone or Android mobile [removed: device.*Data and Insulin Delivery Collaborations*][added: device.]

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 [removed: device to receive and display glucose readings from our transmitter and, in some cases, use the glucose readings for semi-automated insulin delivery.]

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 [removed: of up to $275.0 million that may become due and payable by us upon the achievement of] [added: for] future product regulatory approval and [removed: revenue] [added: sales-based] milestones.

At our election, we may make these [removed: milestone] payments in shares of our common stock or cash.

See Note 2 [added: “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 [removed: Agreement.][added: Agreement, including the number of shares of stock for milestone payments.]

| [ITEM 6.](#i15862298089b493198685c5d6204a6cb_40) | | | [\[Reserved\]](#i15862298089b493198685c5d6204a6cb_40) | | | [68](#i15862298089b493198685c5d6204a6cb_40) | | |

| [ITEM 9C.](#i15862298089b493198685c5d6204a6cb_1422) | | | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#i15862298089b493198685c5d6204a6cb_1422) | | | [86](#i15862298089b493198685c5d6204a6cb_1422) | | |

| | | | [Signatures](#i15862298089b493198685c5d6204a6cb_91) | | | [91](#i15862298089b493198685c5d6204a6cb_91) | | |

- Although many third-party payors have adopted some form of coverage policy on continuous glucose monitoring devices, our products do not always have some form of coverage, including simple broad-based contractual coverage, with third-party payors and we frequently experience administrative challenges in obtaining reimbursement for our customers.

- Managed care trends and consolidation in the health care industry could have an adverse effect on our revenues and results of operations.

Product Candidates

The G6 Pro has many of same features as the G6

*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.

*Dexcom ONE®*

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.

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.

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

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

Data and Insulin Delivery Collaborations

device to receive and display glucose readings from our transmitter and, in some cases, use the glucose readings for semi-automated insulin delivery.

As of December 31, 2021, those single sources include

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*.”

Agreements with our employees also forbid

The FDA and the Food and Drug Branch of the

Violation of the Anti-Kickback Statute is a felony and conviction could result in the assessment of fines of up to $100,000 per violation or imprisonment for up to 10 years or both.

tam” actions.

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

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.

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*All diversity data is self-reported.

We capture ethnic diversity data in the United States only, comprised of the following categories: Black or African American, Hispanic or Latino, Asian, American Indian/Alaskan Native, Native Hawaiian or Other Pacific Islander, Two or More Races.

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.

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.

| [ITEM 6.](#i889b093251984bfb881a094ef59c54bd_37) | | | [Selected Financial Data](#i889b093251984bfb881a094ef59c54bd_37) | | | [68](#i889b093251984bfb881a094ef59c54bd_37) | | |

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.

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

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

like the Apple Watch® and Wear OS by Google devices.

Global revenues associated with the sales of our previous commercial products, the Dexcom G4® Platinum CGM system and G5® Mobile CGM system, or G5 Mobile, amount to less than 10% of our revenue for the fiscal year ended 2020 and we anticipate phasing out these commercial products by the end of 2021.

The IDF estimates that expenditures attributable to diabetes will grow to $845 billion globally by 2045.

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.

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

After a stabilization period with the G5 Mobile, the user is required to calibrate the

sensor with two measurements from a single-point finger stick device and the disposable sensor begins wirelessly transmitting the continuous glucose data at specific intervals to the handheld receiver or compatible mobile device.

Users are prompted by the receiver or mobile app, if using the G5 Mobile, to calibrate the system twice per day with finger stick measurements throughout the use period to ensure reliable operation.

Calibration may be accomplished by using any FDA cleared blood glucose meter.

Our Mesa, Arizona facility has approximately 14,000 square feet of laboratory space and approximately 33,000 square feet of controlled environment rooms.

retaining of additional management, quality assurance, quality control and technical personnel who have the necessary manufacturing experience.

The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the *de novo* classification procedure.

This 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.

Prior to the enactment of the Food and Drug Administration Safety and Innovation Act, or FDASIA, in July 2012, a medical device could only be eligible for *de novo* classification if the manufacturer first submitted a 510(k) pre-market notification and received a determination from the FDA that the device was not substantially equivalent.

FDASIA streamlined the *de novo* classification pathway by permitting (under Section 513(f)(2) of the FDCA) manufacturers to request *de novo* classification directly without first submitting a 510(k) pre-market notification to the FDA and receiving a not substantially equivalent determination.

FDASIA sets a review time for FDA of 120 days following receipt of the *de novo* application, but FDA does not always meet this timeline and has publicly only committed to a review goal of 150 days for 50% of applications.

If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.

The FDA may reject the reclassification petition if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be developed.

In December 2018, the FDA issued proposed regulations to govern the *de novo* classification process, which if finalized would further impact this path to market.

As an alternative to the *de novo* process, a company could also file a reclassification petition, or the FDA could initiate such a process, seeking to change the automatic Class III designation of a novel postamendment device under Section 513(f)(3) of the FDCA.

The FDA issued a final rule (to take effect March 17, 2019) to clarify the process where the FDA initiates such reclassification (issuance of a proposed reclassification order; optional panel consultation; and final reclassification order published in the Federal Register).

Our G4 PLATINUM and G5 Mobile systems (excluding associated Share System functionalities and mobile applications) were classified as devices requiring PMA approval.

After a PMA application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information.

During this review period, the FDA may request additional information or clarification of information already provided.

Also during the review period, an advisory panel of experts from outside the FDA may be

convened to review and evaluate the application and provide recommendations to the FDA.

In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to evaluate compliance with QSR, which requires manufacturers to implement and follow design, testing, control, documentation and other quality assurance procedures.

- our systems may not be safe or effective to the FDA’s satisfaction;

- the manufacturing process or facilities we use may not meet applicable requirements; and

- changes in FDA approval policies or adoption of new regulations may require additional data.

These trials generally require submission of an application for an investigational device exemption, or IDE to the FDA.

The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and eligible for abbreviated IDE requirements.

Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent are approved by appropriate institutional review boards at the clinical trial sites.

The FDA’s approval of an IDE allows clinical testing to go forward, but does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.

To obtain 510(k) clearance, we must submit a pre-market notification demonstrating that the software system is substantially equivalent to a previously cleared 510(k) device or a pre-amendment device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA application.