The Keytruda cliff: understanding the central risk and opportunity in MRK
Keytruda generated $31.7B in 2025 revenue and is approved for more than 40 cancer types. The problem is that its core patent protection expires in 2028, opening the door to biosimilar competition. The market has priced this risk aggressively: MRK trades at a forward P/E of roughly 12x, a 37-46% discount to large-cap pharmaceutical sector multiples, implying a severe post-2028 earnings decline is already baked into the stock.
The bull case is that the discount overestimates the damage. Merck's subcutaneous formulation (Keytruda Qlex) — converting a 30-minute IV infusion to a rapid injection — is designed to lock in patients with more convenient dosing, potentially delaying biosimilar substitution. Simultaneously, Winrevair for pulmonary arterial hypertension grew 88% in Q1 2026, and the oncology pipeline includes multiple Phase 3 programs with PDUFA readouts in 2026. Traders who believe pipeline execution outpaces the patent-cliff narrative find MRK's 12x multiple an attractive entry.
- Monitor PDUFA dates for the oncology pipeline — positive readouts serve as near-term catalysts that compress the patent-cliff discount.
- Winrevair quarterly revenue is the most important growth metric to watch: $525M in Q1 2026, on track for $5-7B peak sales estimates.
- Keytruda subcutaneous form approval globally would be a multi-year positive catalyst that extends the exclusivity runway beyond 2028.