DexCom, Inc. First Quarter 2025 Earnings Release Conference Call
May 1, 2025 04:30 PM ET

Dexcom Appoints Jon Coleman as Chief Commercial Officer

On March 25, 2025, DexCom, Inc. announced the appointment of Jon Coleman as its new chief commercial officer. Coleman will lead the company’s global commercial operations, including sales, marketing, and customer experience.

Coleman brings over 30 years of leadership experience across healthcare sectors. He previously held executive roles at Masimo Corporation, including president of global commercial operations, and served in senior positions at Pfizer’s Consumer Healthcare division, where he led growth across regions such as Asia, Latin America, and Canada. His background also includes roles at Procter & Gamble and Bain & Company.

Dexcom CEO Kevin Sayer praised Coleman’s track record in navigating global healthcare markets and driving growth. Coleman expressed enthusiasm about joining Dexcom at a pivotal time, citing the company's commitment to innovation in glucose biosensing and its potential for global health impact.

Dexcom unveiled its "State of Type 2 Report" at ATTD 2025, highlighting that healthcare professionals increasingly favor technology over medication for managing Type 2 diabetes. The report, based on surveys from over 2,500 participants across Europe and the Middle East, underscores the benefits of continuous glucose monitoring (CGM) and calls for improved access to diabetes technology.

The conference also featured the first-ever accuracy and performance data for Dexcom’s upcoming G7 15 Day system, which demonstrated a mean absolute relative difference (MARD) of 8.0%, making it the most accurate CGM sensor. Additionally, Dexcom announced new integrations, including compatibility with the Omnipod 5 Automated Insulin Delivery System and smart insulin pens like NovoPen 6 and NovoPen Echo Plus, reinforcing its position as the most connected CGM brand.

Key findings from the report reveal that 52% of healthcare professionals see CGM and education as the future of Type 2 diabetes management, while 50% believe CGM should be the standard of care for all patients, regardless of insulin use. However, funding constraints and limited inclusion criteria remain major barriers to widespread CGM adoption.

Dexcom continues to advocate for increased investment in CGM technology, emphasizing its potential to enhance patient outcomes, reduce complications, and lower long-term healthcare costs. The Dexcom G7 15 Day system is currently under FDA review and is expected to further improve accuracy and usability.

DexCom, Inc. announced that it received a warning letter from the U.S. Food and Drug Administration following inspections of its facilities in San Diego, California, and Mesa, Arizona. The letter cited deficiencies in the company’s response to previously identified observations regarding manufacturing processes and quality management systems. The warning does not impact the company’s ability to produce, market, or distribute products, nor does it require a recall. DexCom has submitted multiple responses to the FDA and is working on further corrective actions. The company does not expect the letter to affect its manufacturing capacity or its previously issued 2025 revenue guidance.

dexcom, inc. (nasdaq: dxcm) announced the appointment of renée galá to its board of directors, effective march 6, 2025. galá, currently the president and coo of jazz pharmaceuticals, brings extensive experience in finance, strategic leadership, and operations in the life sciences sector.

before joining jazz pharmaceuticals, galá served as cfo at grail, inc. and theravance biopharma, inc. she also held various finance and business development roles at eli lilly and company.

dexcom’s chairman and ceo, kevin sayer, stated that galá’s expertise in global operations and finance will support dexcom’s mission to enhance metabolic health and drive shareholder value.

Dexcom Receives FDA Warning Letter; No Expected Impact on 2025 Revenue Guidance
San Diego, CA – March 4, 2025 – DexCom, Inc. (Nasdaq: DXCM) announced that it has received a warning letter from the U.S. Food and Drug Administration (FDA) following inspections at its manufacturing facilities in San Diego, California, and Mesa, Arizona. Despite the warning letter, the company does not expect any material impact on its manufacturing capacity or previously issued fiscal year 2025 revenue guidance.

Key Details of the FDA Warning Letter
The warning letter cited deficiencies in Dexcom's response letters to the Form 483 observations issued after FDA inspections in 2024.
San Diego facility inspection: Conducted from October 21, 2024, to November 7, 2024.
Mesa, Arizona facility inspection: Conducted from June 10, 2024, to June 14, 2024.
The observed non-conformities were related to manufacturing processes and quality management systems.
The warning letter does not:
Restrict Dexcom’s ability to manufacture, market, or distribute its products.
Require a recall of any products.
Impact Dexcom’s ability to seek FDA 510(k) clearance for new products.
Dexcom’s Response and Corrective Actions
Dexcom has already submitted several responses addressing the FDA’s concerns and is preparing a detailed written response to the warning letter. The company is implementing corrective actions and will continue to provide regular updates to the FDA.

While Dexcom is working diligently to resolve the issues, the company cannot provide assurances on the FDA’s response timeline or the final outcome of the matter. Until the issues are resolved to the FDA’s satisfaction, further regulatory action remains a possibility.

No Expected Financial Impact
Dexcom reiterated that the FDA warning letter will not impact its 2025 revenue guidance, which was last issued on February 13, 2025. The company remains focused on ensuring compliance and maintaining high-quality manufacturing standards.

Forward-Looking Statements
Dexcom cautioned that while it is taking proactive measures to address the FDA’s concerns, potential risks remain. These include further regulatory action if the FDA finds the company’s response inadequate. Investors are advised to review the company’s latest Form 10-K and Form 10-Q reports for a detailed analysis of risk factors.

DexCom, Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) on March 4, 2025, following inspections of its San Diego, California, and Mesa, Arizona facilities. The FDA cited deficiencies in DexCom’s response to previously issued Form 483 observations regarding non-conformities in manufacturing processes and quality management systems.

Despite the warning, the letter does not restrict DexCom’s ability to manufacture, market, or distribute its products, nor does it impact FDA 510(k) clearance of new products or require product recalls. DexCom has submitted multiple responses to the FDA and is preparing a formal reply to address the concerns. The company remains committed to implementing corrective actions and providing regular updates to the FDA.

DexCom does not expect this issue to have a material impact on its manufacturing capacity or its previously issued fiscal year 2025 revenue guidance. However, the company acknowledges the possibility of further regulatory action if the FDA is not satisfied with its corrective measures.