Can Merck's New Products Aid Growth as Keytruda LOE Test Looms?

Core Insights - Merck is approaching a significant patent cliff with its leading PD-L1 therapy Keytruda, which is set to lose exclusivity in 2028, accounting for over 50% of the company's pharmaceutical sales and generating $23.3 billion in sales during the first nine months of 2025, an 8% increase year over year [1][9] Product Developments - The FDA approved a subcutaneous formulation of Keytruda, known as Keytruda Qlex, in September 2025, which has its own patents extending beyond 2028, potentially mitigating the impact of Keytruda's loss of exclusivity [2] - Merck is diversifying its portfolio with new products like the 21-valent pneumococcal conjugate vaccine Capvaxive and the pulmonary arterial hypertension (PAH) drug Winrevair, both of which have shown strong sales performance [3][4] - Capvaxive generated $480 million in sales in the first nine months of 2025, while Winrevair achieved $976 million in the same period, with management optimistic about their long-term revenue potential [4][5] Competitive Landscape - The PAH market remains highly competitive, with significant players like United Therapeutics and Johnson & Johnson posing challenges for Winrevair [8][10] - Merck's new RSV antibody Enflonsia faces competition from AstraZeneca/Sanofi's Beyfortus and several approved vaccines for RSV prevention [11] Financial Performance - Year-to-date, Merck's shares have increased by 2.9%, underperforming the industry average of 15.6% [12] - Merck's price/earnings ratio stands at 11.59, which is lower than the industry average of 16.91 and its 5-year mean of 12.54, indicating attractive valuation [13] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has slightly increased from $8.94 to $8.98, while the estimate for 2026 has decreased from $9.55 to $8.81 over the past 60 days [15]