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Will MRK's Growing Pipeline Help Navigate the Looming Keytruda LOE?
ZACKS· 2025-06-26 14:51
Core Insights - Merck has developed a significant portfolio of new products and pipeline candidates in oncology, vaccines, neuroscience, and infectious diseases, with plans to launch around 20 new vaccines and drugs in the coming years, many of which have blockbuster potential [1][9] Pipeline Development - Merck's phase III pipeline has nearly tripled since 2021, driven by in-house progress and M&A activities [1][9] - Promising late-stage candidates include enlicitide decanoate/MK-0616 for hypercholesterolemia, tulisokibart for ulcerative colitis, and bomedemstat/MK-3543 for essential thrombocythemia, myelofibrosis, and polycythemia vera [2] - Merck is co-developing three DXd antibody-drug conjugates (ADCs) with Daiichi Sankyo for various cancer indications [3] Market Expansion - Merck has in-licensed global rights to HS-10535, an investigational oral GLP-1 receptor agonist, to enter the obesity market [3] - The company is also focusing on its new 21-valent pneumococcal conjugate vaccine, Capvaxive, and pulmonary arterial hypertension drug, Winrevair, to enhance revenue as Keytruda approaches patent expiration [5][9] Keytruda and Competitive Landscape - Keytruda, a PD-L1 inhibitor, generated $7.21 billion in sales in Q1 2025, reflecting a 6% year-over-year increase, with a projected CAGR of 5.4% over the next three years [6] - Keytruda faces competition from other PD-L1 inhibitors such as Opdivo, Tecentriq, and Imfinzi, which have also shown strong sales growth [7][8][10] Financial Performance - Year-to-date, Merck's shares have decreased by 19.9%, compared to a 1.8% decline in the industry [11] - Merck's price/earnings ratio stands at 8.56, which is lower than the industry average of 14.92 and its 5-year mean of 12.85, indicating attractive valuation [12] - The Zacks Consensus Estimate for 2025 earnings has slightly declined from $8.94 to $8.92 per share over the past 60 days [13]
Should You Buy, Sell or Hold MRK Stock After Q1 Earnings Beat?
ZACKS· 2025-04-28 12:50
Core Viewpoint - Merck reported strong first-quarter 2025 results, exceeding earnings and sales estimates, driven by Keytruda and new product launches, despite challenges in the HPV vaccine sales in China [1][2][28]. Financial Performance - Adjusted earnings were $2.22 per share, a 12% increase year over year, while revenues reached $15.53 billion, up 1% year over year [1]. - Keytruda generated $7.21 billion in sales, a 6% increase year over year, while Gardasil sales declined by 40% due to lower demand in China [2][14]. - Merck maintained its sales guidance for 2025 in the range of $64.1 billion to $65.6 billion, expecting sales to accelerate in the second half of the year [2][25]. Margin and Guidance Adjustments - Adjusted gross margin guidance was lowered by 50 basis points to 80% due to tariff impacts, with an expected cost of $200 million from tariffs [3]. - Adjusted EPS guidance was revised down from $8.88-$9.03 to $8.82-$8.97, including a one-time charge of 6 cents related to an M&A transaction [3]. Key Products and Pipeline - Keytruda remains a significant driver, accounting for approximately 50% of pharmaceutical sales, with ongoing growth expected from early-stage lung cancer indications [4][5]. - Merck's pipeline has expanded significantly, with plans to launch around 20 new vaccines and drugs, including Capvaxive and Winrevair, which have strong revenue potential [9][10][28]. Strategic Initiatives - Merck is pursuing innovative strategies for Keytruda's growth, including combinations with other therapies and developing a personalized mRNA cancer vaccine in partnership with Moderna [6][12]. - The company has invested $12 billion in U.S. manufacturing since 2018, with an additional $9 billion planned through 2028 to enhance supply chain resilience [26]. Market Position and Challenges - Merck's stock has underperformed compared to the industry and S&P 500, with a 16.1% decline year-to-date [16][19]. - Concerns exist regarding the reliance on Keytruda, especially with its patent expiration in 2028 and increasing competition from other therapies [12][13][28].