Will the FDA's Nod for Subcutaneous Keytruda Ease Merck's Headwinds?

Core Insights - Merck's Keytruda (pembrolizumab) has received FDA approval for a subcutaneous formulation, Keytruda Qlex, which is expected to launch commercially later this month [1][2] - The subcutaneous version offers improved patient convenience, reducing administration time from at least 30 minutes for the IV version to as little as one minute [2] - The approval is backed by pivotal studies showing that Keytruda Qlex is at least as effective as the IV formulation, with a regulatory filing for the SC version also under review in Europe [3] Group 1: Keytruda Qlex Approval and Market Impact - The approval of Keytruda Qlex is timely as Merck faces the potential loss of exclusivity for Keytruda IV in 2028, which currently accounts for over 48% of the company's revenue [4] - Keytruda IV generated over $15 billion in sales during the first half of 2025, reflecting an 8% year-over-year increase [4] - The new SC version comes with its own patents that extend protection beyond 2028, allowing Merck to manage Keytruda's lifecycle effectively [5] Group 2: Challenges and Competitive Landscape - Merck is experiencing a decline in sales of its second-largest product, Gardasil, which has dropped 48% year over year due to weak demand in China [6] - Competitive pressure for Keytruda may increase from dual PD-1/VEGF inhibitors like Summit Therapeutics' ivonescimab, which has shown potential to outperform Keytruda [9][10] - Merck is actively pursuing innovative combinations and partnerships, including a collaboration with Moderna to develop a personalized mRNA therapeutic cancer vaccine [8] Group 3: Financial Performance and Valuation - Merck's shares have underperformed the industry year to date, with a current price/earnings (P/E) ratio of 8.67, lower than the industry average of 14.88 and its 5-year mean of 12.70 [11][13] - Movements in EPS estimates for 2025 and 2026 have been mixed over the past 60 days, indicating uncertainty in future earnings [15] - Merck currently holds a Zacks Rank 3 (Hold), reflecting a cautious outlook [16]