Several risks merit attention. First, oral GLP-1 disruption. If a competitor produces a superior oral GLP-1 with efficacy approaching the injectable benchmark, the addressable market could shift toward oral within 24 months. Lilly is in the oral race but is not necessarily winning it.
Second, manufacturing scaling at this pace creates execution risk. The 2025 capacity ramp had a single manufacturing site setback that compressed the third quarter Zepbound supply. Repeat events would compress quarterly revenue against guidance.
Third, payer reimbursement compression. The current GLP-1 list price ranges from roughly $1,000 to $1,300 per month. Net pricing after rebates is materially lower. Continued rebate pressure from PBMs and Medicare price negotiation are real overhangs. The IRA negotiation eligibility for tirzepatide begins in the late 2020s; the longer-tail price erosion is meaningful.
Fourth, competitor entry. Beyond Novo, several smaller players are advancing GLP-1 candidates. Roche, Pfizer, and Amgen all have programs. Generic biosimilar entry is several years away, but the second-tier branded competition will arrive in 2027-2028.
None of these risks are dispositive in the next 18-24 months. The compounding revenue trajectory through that window is largely de-risked. The risk picture matters more for the FY28+ trajectory.