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AZN Gets CHMP Nod for Label Expansion of Koselugo & Tezspire
ZACKS· 2025-09-23 17:01
Key Takeaways CHMP recommended AZN's Koselugo for adult NF1 patients with inoperable plexiform neurofibromas.Recommendation was backed by the phase III KOMET study showing improved response rates with Koselugo.CHMP recommended Tezspire for the treatment of adult patients with CRSwNP in the EU.AstraZeneca (AZN) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of its oral, selective MEK inhibitor, Koselugo (selumetinib ...
Merck Q1 Earnings Coming Up: Should You Buy the Stock Now?
ZACKS· 2025-04-22 12:35
Core Viewpoint - Merck is set to report its first-quarter 2024 earnings on April 24, with sales and earnings estimates at $15.48 billion and $2.16 per share respectively, while earnings estimates for 2025 have seen a slight decline from $9.01 to $8.96 per share over the past month [1][2]. Earnings Performance - Merck has consistently exceeded earnings expectations in the last four quarters, achieving an average earnings surprise of 4.68% [2][3]. - The most recent quarter showed an earnings surprise of 1.78% [2]. Sales Drivers - The anticipated top-line growth in Q1 is expected to be driven by the cancer drug Keytruda, supported by increased patient demand and additional indications [5]. - Keytruda's sales are projected at $7.55 billion according to the Zacks Consensus Estimate, while a higher estimate of $7.82 billion is provided [6]. Product Performance - U.S. sales of Keytruda in the previous quarter benefited from approximately $200 million in wholesale inventory buy-in, which is expected to reverse in Q1 2025 [7]. - Sales of the new drug Welireg are likely to have increased due to its uptake for advanced renal cell carcinoma [13]. - The HPV vaccine Gardasil is expected to see mixed results, with U.S. sales increasing due to higher pricing, while ex-U.S. sales may decline due to lower demand in China [10]. Competitive Landscape - Merck's reliance on Keytruda raises concerns about the company's ability to diversify its product lineup ahead of the drug's loss of exclusivity in 2028 [23]. - Competitive pressure for Keytruda may increase, particularly from Summit Therapeutics' candidate ivonescimab, which has shown promising results in trials [24]. Valuation and Market Performance - Merck's stock has declined 21.1% year-to-date, underperforming the industry and the S&P 500 [16]. - The company's shares trade at a forward price/earnings ratio of 8.44, which is lower than the industry average of 15.07 and its own 5-year mean of 13.10 [19]. Investment Outlook - Merck's portfolio includes several blockbuster drugs, with Keytruda being a significant revenue driver, alongside growth in animal health and vaccine products [22]. - Despite challenges such as declining sales for Gardasil in China and potential competition for Keytruda, the company is expected to maintain strong fundamentals in the long term [26][27].