Dexcom (DXCM) 10-K risk factor changes: FY2023 vs FY2022

For the fiscal year ended December 31, [removed: 2022][added: 2023]

[removed: ][added: ]

(Address of principal executive [removed: offices)][added: offices, including zip code)]

| Common Stock, $0.001 Par Value Per Share | | | DXCM | | | [removed: The] Nasdaq [removed: Stock] [added: Global Select] Market [removed: LLC] | | |

[removed: Large accelerated filer ☒ Accelerated filer ☐] [added: |] Non-accelerated filer [added: | | |] ☐ [added: | | | | | |] Smaller reporting company [removed: ☐ Emerging growth company] [added: | | |] ☐ [added: | | |]

As of June 30, [removed: 2022,] [added: 2023,] 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: $29.1] [added: $49.4] billion based on the closing sales price of [removed: $74.53] [added: $128.51] per share as reported on the Nasdaq Global Select [removed: Market.][added: Market on that date.]

| Class | | | | | | Outstanding at February [removed: 2, 2023] [added: 1, 2024] | | |

| Common stock, $0.001 par value per share | | | | | | [removed: 386,413,690] [added: 385,515,421] | | |

Portions of the registrant’s definitive proxy statement relating to its [removed: 2023] [added: 2024] 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 [removed: numbers.][added: numbers, which proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year covered by this Form 10-K.]

| [ITEM [removed: 1.](#i6eef640963c94f0198129aab5beef55a_16)] [added: 1.](#i70f957301cc34339a22f629982cd0734_16)] | | | [removed: [Business](#i6eef640963c94f0198129aab5beef55a_16)] [added: [Business](#i70f957301cc34339a22f629982cd0734_16)] | | | [removed: [5](#i6eef640963c94f0198129aab5beef55a_16)] [added: [6](#i70f957301cc34339a22f629982cd0734_16)] | | |

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| [ITEM [removed: 15.](#i6eef640963c94f0198129aab5beef55a_100)] [added: 15.](#i70f957301cc34339a22f629982cd0734_169)] | | | [removed: [Exhibits](#i6eef640963c94f0198129aab5beef55a_100)] [added: [Exhibits](#i70f957301cc34339a22f629982cd0734_169)] and [Financial Statement [removed: Schedules](#i6eef640963c94f0198129aab5beef55a_100)] [added: Schedules](#i70f957301cc34339a22f629982cd0734_169)] | | | [removed: [91](#i6eef640963c94f0198129aab5beef55a_100)] [added: [90](#i70f957301cc34339a22f629982cd0734_169)] | | |

| [ITEM [removed: 16.](#i6eef640963c94f0198129aab5beef55a_103)] [added: 16.](#i70f957301cc34339a22f629982cd0734_172)] | | | [Form 10-K [removed: Summary](#i6eef640963c94f0198129aab5beef55a_103)] [added: Summary](#i70f957301cc34339a22f629982cd0734_172)] | | | [removed: [93](#i6eef640963c94f0198129aab5beef55a_103)] [added: [92](#i70f957301cc34339a22f629982cd0734_172)] | | |

*Except for historical financial information contained herein, the matters discussed in this [added: Annual Report on] Form 10-K may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, [added: or the Exchange Act,] and subject to the safe harbor created by the Securities Litigation Reform Act of 1995.

Such statements include declarations regarding our [removed: intent, belief, or current expectations] [added: operations, financial condition] and [removed: those of our management.][added: prospects, and business strategies, and are based on management’s current* *intent, beliefs, expectations, and assumptions.]

Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks, uncertainties and other factors, some of which are beyond our control; actual results could differ materially from those indicated [added: or implied] by such forward-looking statements.

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, but are not limited to: (i) that the information is of a preliminary nature and may be subject to further adjustment; (ii) those risks and uncertainties identified under “Risk Factors”; and (iii) the other risks detailed from time-to-time in our reports and registration statements filed with the Securities and Exchange Commission, or [added: the] SEC.

Except as required by law, we undertake no obligation to revise or update publicly any forward-looking statements, whether as a result of new information, future events or [removed: otherwise.*][added: otherwise.]

- We are subject to cost-containment efforts by third-party payors that could result in reduced product pricing and/or sales of our products and cause a reduction in [removed: future] revenue.

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

If we are unable to [removed: secure] [added: obtain] adequately broad coverage or reimbursement for our products or any future products from third-party payors, our revenue may be negatively impacted.

- We are subject to complex and evolving U.S. and foreign laws and regulations and other requirements [removed: and policy initiatives] regarding privacy, data protection, security, [removed: data access] and other matters.

or

| Large accelerated filer | | | ☒ | | | | | | Accelerated filer | | | ☐ | | |

| | | | | | | | | | Emerging growth company | | | ☐ | | |

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

Shares held by persons who may be deemed affiliates have been excluded.

This determination of affiliate status with respect to the foregoing calculation is not a determination for other purposes.

| [I](#i70f957301cc34339a22f629982cd0734_3752)[TEM 1C.](#i70f957301cc34339a22f629982cd0734_3752) | | | [Cybersecurity](#i70f957301cc34339a22f629982cd0734_3752) | | | [67](#i70f957301cc34339a22f629982cd0734_3752) | | |

| | | | [Signatures](#i70f957301cc34339a22f629982cd0734_175) | | | [93](#i70f957301cc34339a22f629982cd0734_175) | | |

Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information.

Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.*

| Corporate Information | | | | | | | | | | | | | | |

Our website address is located at dexcom.com and our investor relations website is located at investors.dexcom.com.

We file electronically with the SEC our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

We make available on our website, free of charge, copies of these reports and other information as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

We announce material information to the public about us, our products, and other matters through a variety of means, including filings with the SEC, press releases, public conference calls, presentations, webcasts, and our investor relations website in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD.

We also routinely post important information for investors on our website noted above, and we may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.

Accordingly, investors should monitor the Investor Relations portion of our website noted above.

Except as expressly set forth in this Annual Report on Form 10-K, the contents of our website is not incorporated by reference into, or otherwise to be regarded as part of, this Annual Report on Form 10-K or in any other report or document we file with the SEC, and any references to our website is intended to be inactive textual references only.

The information disclosed by the foregoing channels could be deemed to be material information.

As such, we encourage investors, the media, and others to follow the channels listed above and review the information disclosed through such channels.

"Dexcom", “Dexcom Clarity”, and “Dexcom One”, and other trademarks of ours appearing in this report are our property.

Other service marks, trademarks and trade names referred to in this Form 10-K are the property of their respective owners.

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

*Dexcom Stelo*®

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

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

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

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

The general purpose of these development and commercial relationships is

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

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

allows some CGM systems to communicate with automated insulin delivery systems.

- Supporting innovation through technology integration partnerships.

Likewise, Abbott Diabetes Care has

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

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

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

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

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.

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| | | | | | | (Nasdaq Global Select Market) | | |

Except with respect to information specifically incorporated by reference in the Form 10-K, the Proxy Statement is not deemed to be filed as part hereof.

| | | | [Signatures](#i6eef640963c94f0198129aab5beef55a_106) | | | [94](#i6eef640963c94f0198129aab5beef55a_106) | | |

- 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.

Our Internet website address is www.dexcom.com.

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.

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.

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.

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

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

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

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.

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.

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.

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.

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

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

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.

- 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.

Disposable Sensor and Reusable Transmitter

Our sensor includes a tiny wire-like electrode coated with our sensing membrane system.

This disposable sensor comes packaged with an integrated insertion device and is contained in a small plastic housing platform, or pod.

The base of the pod has adhesive that attaches it to the skin.

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.

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.

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

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

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

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

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

A new sensor and pod can then be inserted and used with the same receiver and transmitter for a subsequent use period.

Handheld Receiver

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

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

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

Additionally, when glucose values are inappropriately high or low, the receiver provides an audible alert or vibrates.

The receiver is a self-contained, durable unit with a rechargeable battery.

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