Reimbursement policy changes - CMS or commercial payers could reduce CGM coverage or reimbursement rates, particularly for Type 2 non-insulin users where clinical evidence is still developing. Medicare competitive bidding could pressure pricing.
Technology disruption from non-invasive glucose monitoring (optical, RF-based sensors) or implantable long-duration sensors (180+ days) that eliminate recurring revenue model. Apple, Samsung rumored to be developing non-invasive solutions.
Regulatory pathway changes - FDA could tighten accuracy requirements or create faster approval paths for competitors, eroding Dexcom's 18-24 month development lead time advantage.
Abbott FreeStyle Libre aggressive pricing ($60-75/month versus Dexcom's $300+ list price) and retail pharmacy distribution gaining share in price-sensitive Type 2 segment. Libre 3 matches G7 on form factor.
Medtronic re-entering standalone CGM market with Simplera sensor (2024 launch) leveraging installed base of 400K+ insulin pump users. Vertical integration threat if pump manufacturers bundle proprietary sensors.
Emerging biosensor companies (Biolinq, Know Labs) developing lower-cost manufacturing processes or alternative sensing modalities that could commoditize CGM technology.
Debt refinancing risk - $1.4B in convertible notes with maturities in 2025-2028 may need refinancing at higher rates if not converted, increasing interest expense from current $40-50M annually.
Manufacturing concentration - 70%+ of sensor production in Mesa, Arizona facility creates operational risk from natural disasters, equipment failures, or quality issues. Malaysian facility provides partial redundancy but not full backup capacity.
Foreign currency exposure - 15% of revenue from international markets (Euro, GBP, AUD) creates translation risk. Unhedged exposure could impact reported revenue by 100-200 bps in strong dollar environments.
StructuralCompetitiveBalance Sheet