Sentences and paragraphs of DXCM's Risk Factors and MD&A, 10-K 2026-02-12 against 10-K 2025-02-18.
Each links to the text at sec.gov.
AddedRisk Factors
In the United States and other countries, government and private sector access to health care products continues to be a subject of focus, and efforts to reduce health care costs are being made by third-party payors. Most of our customers rely on third-party payors, including government programs and private health insurance plans, to cover the cost of the G6, G7, G-7 15 Day, Dexcom One, and Dexcom ONE+. We expect that these continuing cost reduction and containment measures could result in lower prices for these products and lower reimbursement rates, as well as could lead to patients being unable to obtain approval for coverage or payment from these third-party payors resulting in costs being shifted to patients for these products. Additionally, we may experience pricing pressure if our products are increasingly subject to competitive bidding processes, which include substantial costs and managerial time to prepare bids and proposals for contracts that may not be awarded to us or may be split among competitors. For example, in June 2025, the Centers for Medicare & Medicaid Services published a proposed rule that would subject continuous glucose monitors to the competitive bidding process, which could negatively impact our reimbursement and result in price decreases. In late 2025, CMS extended the DMEPOS competitive bidding program to include our CGMs and receivers, with contracting beginning in 2027 and payment changes taking effect in 2028. Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items in CBAs. CMS anticipates that ten (10) contracts will be awarded for CGMs. However, while the competitive bidding program previously used CBAs for contract awards, CMS determined that for CGMs and certain other DME, a RID CBA was more appropriate. It remains to be seen whether CGMs will be covered under a single, nationwide RID CBA or whether regional RID CBAs will be established. In any event, the bid process is expected to result in lower Medicare reimbursement for CGM systems, particularly because CMS is changing the pricing under the RID CBA by setting a single payment amount for covered items at the 75th percentile of the winning bids, rather than using the maximum winning bid. Further, CMS has reclassified CGMs and insulin infusion pumps to items that require frequent and substantial servicing and will phase in monthly rental payments for these items. CMS will bundle the rental amount for the receiver device with payment for the supplies and accessories in the new payment amount. The bid limit will be monthly fee schedule amounts for the supplies plus the average purchase fee schedule amounts for the CGM receiver device divided by 60 (intended to capture the 5-year useful life of the device.) As a result, we expect that Medicare reimbursement for our CGM systems will decrease beginning in 2028. CMS is required by law to recompete these contracts at least once every three years and to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas to match competitive bidding prices. The implementation of the competitive bidding program is expected to result in reduced Medicare payment for CGMs in both competitive bidding areas and non-competitive bidding areas. Additionally, the new bidding system will contain a “country of origin” question to obtain information on where products are manufactured; however, it is unclear how CMS intends to use this information. Given that we maintain offshore manufacturing facilities, country of origin reporting could have an impact on our business. Competitive bidding could negatively impact our reimbursement and result in price decreases. To the extent these
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
On July 4, 2025, President Trump signed the budget reconciliation bill (entitled “One Big Beautiful Bill Act”, or the Bill) to meet spending targets aimed at funding the Administration’s domestic priorities that includes significant changes to the Medicaid program. Congressional Budget Office, or CBO, preliminary estimates show that the Medicaid provisions would reduce Medicaid spending by $1 trillion and will increase the number of people without health insurance by at least 11.8 million by 2034. Some key proposed changes to the Medicaid Program include, but are not limited to: work requirements; cost sharing of up to $35 per service on expansion adults who exceed the official poverty threshold; stricter eligibility requirements for non-U.S. citizens; requirements for states to conduct eligibility redeterminations at least every six months for Medicaid expansion adults; and prohibitions on states from establishing any new provider taxes or from increasing the rates of existing taxes, among other changes. Decreased federal funding and stricter eligibility requirements may result in more restrictive Medicaid programs at the state level and fewer individuals eligible for coverage, which could have an adverse impact on the number of individuals who seek to use our products and services.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
•loss or reduction of insurance coverage for individuals, resulting in higher cost obligations for users with respect to their purchase of our products;
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
We are also aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for the general health and wellness, or population health space. Some of the companies developing or marketing competing devices are large and well-known publicly traded companies. Such competitors may benefit from guidance issued on January 6, 2026 by the FDA’s Center for Devices and Radiological Health that effectively broadens the range of products that may be considered “general wellness devices,” including wearables that provide readings around bodily functions and vital signs such as heart rate, blood pressure, and blood glucose.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
If our CGM systems do not achieve and maintain an adequate level of acceptance by people with diabetes, those seeking to optimize metabolic health, healthcare professionals, including physicians, and third-party payors, our future revenue may be reduced and our business may be harmed.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
From time to time, the FDA conducts inspections of our facilities and may issue Form 483 findings related to our operations and may issue warning letters or take other administrative or enforcement actions asserting noncompliance with FDA laws and regulations. In March 2025, we received an FDA warning letter following inspections of our facilities in San Diego, California, and Mesa, Arizona. In the warning letter, the FDA cited deficiencies in the response letters sent by us to the FDA following the Form 483, List of Investigational Observations that was delivered to us in connection with the inspection of our San Diego, California facility that occurred from October 2024 through November 2024, and the inspection of our Mesa, Arizona facility that occurred in June 2024. The warning letter describes observed non-conformities in manufacturing processes and our quality management system. We take the matters identified in the warning letter seriously and have submitted responses to the Form 483 and to the FDA warning letter. While the warning letter does not restrict our ability to produce, market, manufacture or distribute products, require recall of any products, nor restrict our ability to seek FDA 510(k) clearance of new products, we may fail to satisfy these regulatory requirements to the FDA’s satisfaction, and any failure to do so could result in the foregoing occurring.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
While we intend to undertake certain corrective actions and provide regular updates to the FDA in order to meet the requirements set forth by FDA in the warning letter, we cannot give any assurances that the FDA will be satisfied with our response or as to the date we expect to resolve the matters included in the FDA warning letter. Until the issues cited in the warning letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice, including as described above.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
Notably, the new bidding system for Medicare competitive bidding will contain a “country of origin” question to obtain information about where products are manufactured. It is unclear how CMS intends to use this information and what impact this could have, if any, on our offshore manufacturing activities.
Read it in 10-K 2026-02-12 at sec.gov ↗
Show the other 7
AddedRisk Factors
information, limited ability to restore the systems in the event of a systems failure or interruption, greater risk of a security breach resulting in destruction, alteration or misuse of valuable information, including proprietary business information and personally identifiable information of individuals, all of which could expose us to risks of data or financial loss, litigation and liability.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
Moreover, we are subject to various operational, compliance, and reputational risks associated with our adoption and utilization of AI technologies, including inaccurate or unpredictable outputs, such as errors or hallucinations, that may impair decision‑making, disrupt operations, or expose sensitive information. Integrating AI into our systems may also expand our cybersecurity attack surface, increasing exposure to data breaches, loss of intellectual property, or inadvertent disclosure of confidential data. Although we have taken steps intended to mitigate risks related to our use of AI, there can be no assurance that our use of AI will yield the anticipated benefits or that we will be able to effectively mitigate the associated risks. Externally, the rapid adoption of AI by competitors and malicious actors heightens risks as threat actors leverage AI to execute more sophisticated cyberattacks and social‑engineering campaigns, while competitor use of AI may accelerate innovation cycles and intensify competitive pressures. Any of these events could have a material adverse effect on our business, financial condition and results of operations.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
products and to promote use of our products, and which may in turn lead to decreased product sales and negatively impact our business, financial condition and results of operations.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedRisk Factors
We have been involved in various patent infringement actions in the past and in 2024, we entered into a settlement and license agreement with Abbott to settle all pending patent infringement legal proceedings brought by Abbott against us. We granted Abbott and its affiliates, and Abbott and its affiliates granted us and our affiliates, a worldwide, royalty-free, non-exclusive, fully paid-up license to certain patents and patent applications relating to analyte sensing, including to all the patents asserted in the settled litigation. As part of the agreement, each party, on behalf of itself and its affiliates, also entered into a covenant not to sue until December 20, 2034, and agreed on behalf of themselves and their affiliates to refrain from challenging the patents and patent applications licensed
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedMD&A
We assess the value of our inventory on a quarterly basis and write down inventories to the lower of their cost or net realizable value based on quality control data, obsolescence, or excess relative to our forecasted demand. Significant judgment is applied in evaluating quality control testing data, assessing whether non-conforming inventory can be remediated, reworked, or otherwise partially recovered, and in some cases, estimating our forecasted demand.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedMD&A
Other income, net Other income, net, increased primarily due to $79.5 million in higher net gains on equity investments and $8.7 million in higher net foreign currency gains, offset by $21.5 million in lower interest and dividend income on our cash, cash equivalents, and marketable securities portfolio. The decrease in interest income was primarily related to a change in market interest rates, as well as a decrease in the average invested balances compared to the same period in 2024.
Read it in 10-K 2026-02-12 at sec.gov ↗
AddedMD&A
Twelve Months Ended December 31, (In millions) 2025 2024 $ Change Net cash provided by operating activities $ 1,440.7 $ 989.5 $ 451.2 Net cash provided by (used in) investing activities 536.0 (207.5) 743.5 Net cash used in financing activities (1,686.4) (734.8) (951.6) Effect of exchange rate changes on cash, cash equivalents and restricted cash 21.5 (7.4) 28.9 Increase in cash, cash equivalents and restricted cash $ 311.8 $ 39.8 $ 272.0
Read it in 10-K 2026-02-12 at sec.gov ↗
