Enflonsia
Search documents
Merck's Non-Oncology Drugs Q3 Performance: What to Expect
ZACKS· 2025-10-24 15:06
Core Insights - Merck (MRK) is set to report its third-quarter 2025 results on October 30, with a focus on the sales performance of its leading cancer drug, Keytruda, which contributed over 50% of the company's pharmaceutical sales in the first half of 2025 [1][9] - The company is also monitoring the performance of its non-oncology drugs, particularly the newly approved 21-valent pneumococcal conjugate vaccine, Capvaxive, and the pulmonary arterial hypertension (PAH) drug, Winrevair, both of which showed strong sales in the first half of 2025 [2][9] Sales Performance - Keytruda remains a significant revenue driver, but its exclusivity is set to expire in 2028, prompting investors to pay attention to non-oncology products [2] - Capvaxive generated sales of $236 million, while Winrevair achieved $615 million in sales during the first half of 2025 [2] Growth Projections - The new drugs are expected to perform well in Q3 2025, supported by their strong initial uptake [3] - Merck's Animal Health business is also contributing to revenue growth, with an estimated compound annual growth rate (CAGR) of 5.9% over the next three years [3] Product Launches and Approvals - Merck's RSV antibody, Enflonsia, was approved in the U.S. in June 2025 and is under review in the EU, with plans for launch to protect infants during their first RSV season [4] - A fixed-dose combination for HIV treatment is also under review, with an FDA decision expected in April next year [4] Competitive Landscape - Winrevair faces competition in the PAH market from major players like United Therapeutics and Johnson & Johnson, which reported significant revenues from their PAH products [5][6] - Enflonsia will compete with AstraZeneca/Sanofi's RSV antibody, Beyfortus, and other vaccines approved for RSV prevention [6][7] Stock Performance and Valuation - Year-to-date, Merck's shares have declined by 12.3%, underperforming the industry and the S&P 500 [8] - The company's shares trade at a price/earnings ratio of 9.33, which is lower than the industry average of 15.56 and its 5-year mean of 12.63, indicating attractive valuation [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has slightly decreased from $8.94 to $8.92, while the estimate for 2026 has decreased from $9.55 to $9.44 over the past 60 days [11]
Will Declining Gardasil Sales Ail MRK's Top Line in Q3 Earnings?
ZACKS· 2025-10-17 17:21
Core Insights - Merck is experiencing significant challenges with its second-largest product, Gardasil, which is a vaccine for preventing certain cancers caused by human papillomavirus. Sales, which had been rising until 2022, began to decline in 2024 and continued to struggle in 2025 [1][10]. Sales Performance - In the first half of 2025, Gardasil sales dropped 48% year-over-year to $2.45 billion, primarily due to weak demand in China amid an economic slowdown. This decline has led to higher-than-normal inventory levels at Merck's partner in China, Zhifei [2][10]. - Merck has decided to temporarily halt shipments of Gardasil to China to allow for inventory reduction, with no expected resumption of shipments until at least the end of 2025. Sales are projected to decline significantly in 2025 compared to 2024 levels [3][10]. - Demand for Gardasil is also weak in Japan, with expectations of continued low sales in both China and Japan for the latter half of 2025. Estimates suggest a negative compound annual growth rate (CAGR) of 15.1% for Gardasil sales over the next three years [4]. Other Vaccines and Competitive Landscape - Besides Gardasil, Merck markets several other vaccines, including ProQuad, M-M-R II, Varivax, Vaxneuvance, RotaTeq, Pneumovax 23, and the newly approved Capvaxive [5]. - Sales of other vaccines, such as ProQuad and Pneumovax 23, also saw declines in the first half of 2025. Merck's new RSV antibody, Enflonsia, was approved in the U.S. in June 2025 and is under review in the EU, aimed at protecting infants during their first RSV season [6]. - Enflonsia is the first treatment designed to protect infants with a uniform dose regardless of weight, but it faces competition from AstraZeneca and Sanofi's RSV antibody, Beyfortus, which achieved blockbuster status in its first full year of sales in 2024 [7][8]. Financial Performance and Valuation - Year-to-date, Merck's shares have declined by 15.8%, underperforming the industry, sector, and S&P 500 [9]. - From a valuation perspective, Merck's shares trade at a forward price/earnings ratio of 8.97, which is lower than the industry average of 15.62 and its 5-year mean of 12.64 [11]. - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $8.94 to $8.92, and for 2026, it has decreased from $9.55 to $9.44 over the past 60 days [12].
Merck Falls 14% YTD: Time to Buy, Sell or Hold the Stock?
ZACKS· 2025-09-11 15:05
Core Insights - Merck (MRK) is a leading pharmaceutical company with a strong oncology portfolio, primarily driven by its blockbuster drug Keytruda, which accounts for over 50% of pharmaceutical sales [6][9][25] - The company is actively pursuing mergers and acquisitions to enhance its pipeline and diversify its product offerings, particularly in light of the impending loss of exclusivity for Keytruda in 2028 [11][19][30] - Despite strong sales growth from Keytruda, Merck faces challenges including a significant decline in Gardasil sales due to weak demand in China and competitive pressures on its drug portfolio [16][19][30] Group 1: Keytruda and Sales Performance - Keytruda's sales rose approximately 7% in the first half of 2025, benefiting from increased uptake in early-stage non-small cell lung cancer [7][9] - Merck is developing new strategies to sustain Keytruda's growth, including innovative combinations with other therapies and a subcutaneous formulation under FDA review [8][10] - The company's shares have declined nearly 14% in 2025, underperforming the industry and the S&P 500 [2][9] Group 2: Pipeline and M&A Activity - Merck's pipeline has nearly tripled since 2021, with plans to launch around 20 new vaccines and drugs, including Capvaxive and Winrevair, which have strong revenue potential [12][15] - The acquisition of Verona Pharma for approximately $10 billion is expected to bolster Merck's cardio-pulmonary pipeline [15][29] - Regulatory progress includes the approval of the RSV antibody Enflonsia in the U.S. and ongoing reviews for other products [13][14] Group 3: Challenges and Market Dynamics - Gardasil sales fell 48% in the first half of 2025, primarily due to sluggish demand in China, leading to a temporary halt in shipments [16][17] - Competitive pressures are increasing for Keytruda, particularly from new dual PD-1/VEGF inhibitors that may challenge its market position [20][21] - Merck's reliance on Keytruda raises concerns about its ability to diversify its product lineup and grow its non-oncology business ahead of the LOE period [19][30] Group 4: Financial Outlook and Valuation - Merck's shares are currently trading at a price/earnings ratio of 8.95, which is lower than the industry average of 14.78 [21] - Earnings estimates for 2025 have slightly increased, while those for 2026 have decreased, indicating mixed market sentiment [23] - A new multi-year optimization initiative aims to save $3 billion in annual costs by the end of 2027, which may help mitigate revenue gaps from Keytruda's LOE [29][30]
MRK Posts Cholesterol Drug Data, Focus Shifts Back to Its Pipeline
ZACKS· 2025-09-03 15:11
Core Insights - Merck (MRK) is experiencing growth driven by new products and a robust pipeline, particularly in oncology, vaccines, and infectious diseases [1][2] - The company's phase III pipeline has nearly tripled since 2021, positioning it to launch around 20 new vaccines and drugs in the coming years, many of which have blockbuster potential [2][10] Pipeline and Product Development - Promising late-stage candidates include enlicitide decanoate/MK-0616 for hypercholesterolemia, tulisokibart for ulcerative colitis, and bomedemstat for blood disorders [3][6] - The CORALreef Lipids study demonstrated that enlicitide decanoate significantly reduced LDL cholesterol levels compared to placebo, meeting all primary and key secondary endpoints [4][5][10] - If approved, enlicitide decanoate could be the first oral PCSK9 inhibitor, potentially transforming LDL management [6][10] Competitive Landscape - The cholesterol management market is competitive, with existing PCSK9 inhibitors like Amgen's Repatha and Regeneron's Praluent, as well as AstraZeneca's developing oral PCSK9 inhibitor, AZD0780 [7][8] Long-Term Growth Strategy - Merck is focusing on new drug approvals to sustain growth, especially as its blockbuster Keytruda faces loss of exclusivity in 2028 [11] - New products like the 21-valent pneumococcal conjugate vaccine Capvaxive and pulmonary arterial hypertension drug Winrevair are expected to generate significant revenues [11][12] Financial Performance and Valuation - Year-to-date, Merck's shares have decreased by 14.1%, contrasting with a 0.5% decline in the industry [13] - Merck's price/earnings ratio is currently at 9.12, lower than the industry average of 14.78, indicating attractive valuation [14] - The Zacks Consensus Estimate for 2025 earnings has slightly increased, while the estimate for 2026 has decreased [15]
2 Top Stocks Down 16% and 17% This Year to Buy and Hold
The Motley Fool· 2025-07-11 09:36
Core Viewpoint - The article highlights the potential investment opportunities in healthcare companies Merck and Bristol Myers Squibb, which are currently undervalued due to company-specific challenges but have strong long-term prospects. Group 1: Merck - Merck is nearing the loss of patent exclusivity for its key drug Keytruda, which is expected to face biosimilars by the end of the decade [4] - Despite the challenges, Merck's subcutaneous version of Keytruda has shown positive phase 3 results, potentially extending its patent exclusivity into the next decade [5] - The subcutaneous formulation is easier and faster to administer, reducing patient and physician time in the administration process by 49.7% and 45.7% respectively [6] - Merck has a strong pipeline with new approvals, including Winrevair and Enflonsia, and offers a reliable dividend program [7][8] - The stock's forward price-to-earnings ratio is 9.1, significantly lower than the healthcare industry average of 16.3, indicating potential upside for long-term investors [8] Group 2: Bristol Myers Squibb - Bristol Myers Squibb is facing patent expiration for its cancer drug Opdivo and has already lost exclusivity for Revlimid and Sprycel [9] - The company reported a 6% year-over-year revenue decline to $11.2 billion in the first quarter, but its growth portfolio saw a 16% increase in sales to $5.6 billion [11] - BMS has received recent approvals, including a subcutaneous version of Opdivo, which will help mitigate losses from biosimilar competition [10] - The company has a robust pipeline and is expected to secure additional approvals, positioning it to navigate current challenges [12] - Bristol Myers Squibb's stock is undervalued with a forward P/E ratio of 7, suggesting strong long-term return potential despite a 17% decline this year [13]
Will Novo Nordisk's Rare Disease Bets Reduce GLP-1 Reliance?
ZACKS· 2025-07-04 14:56
Core Insights - Novo Nordisk (NVO) has achieved significant growth driven by the success of its semaglutide-based therapies, Wegovy and Ozempic, while also diversifying into rare blood disorders [1][9] Product Portfolio - Key marketed hemophilia therapies include NovoSeven and Esperoct, contributing incremental revenues [2] - Alhemo has recently been approved in the EU for hemophilia A or B with inhibitors, although it is not yet approved in the U.S. [3] - The company is evaluating Mim8 in a late-stage program for hemophilia A, with regulatory submission anticipated in 2025 [4] Competitive Landscape - Eli Lilly (LLY) generates substantial revenue from its tirzepatide medicines and has a diverse product range across various therapeutic areas, including oncology and immunology [5] - Merck (MRK) is also expanding its therapeutic reach beyond its flagship oncology drug Keytruda, with new products expected to generate significant long-term revenues [6] Stock Performance and Valuation - Year-to-date, Novo Nordisk shares have declined by 19.6%, underperforming the industry and the S&P 500 [7][8] - The company's shares trade at a forward price/earnings ratio of 16.31, higher than the industry average of 15.09, but below its five-year mean of 29.25 [10] Earnings Estimates - Earnings estimates for 2025 have improved from $3.89 to $3.93 per share, while 2026 estimates have decreased from $4.76 to $4.58 [15] - The stock's return on equity is 80.95%, significantly higher than the industry average of 33.55% [18]
美股疫苗股将迎来巨震?美国官方将就流感疫苗与硫柳汞进行投票
智通财经网· 2025-06-26 13:46
Group 1: Vaccine Review and Recommendations - The reformed U.S. vaccine advisory group is set to vote on a mercury-containing compound and a common childhood vaccine, following a decision to reassess the childhood vaccination schedule [1] - The Advisory Committee on Immunization Practices (ACIP) will determine which flu virus strains to include in the fall vaccines and will vote on the use of thimerosal, a mercury-based preservative [1] - The committee will also review the use of the MMRV vaccine in children under four years old, which is typically administered to infants aged 12 to 15 months [1][3] Group 2: Changes in Advisory Committee Membership - U.S. Health and Human Services Secretary Robert F. Kennedy Jr. recently dismissed previous vaccine experts from ACIP and appointed new members, many of whom oppose vaccination [2] - The restructured expert group will review current childhood immunization schedules, including vaccines that have not been reviewed in seven years, such as the hepatitis B vaccine [2] Group 3: Concerns Over Vaccine Safety and Efficacy - The discussion on the MMRV vaccine comes amid a measles outbreak in the U.S., which has resulted in fatalities [3] - Concerns have been raised that the committee may decide against recommending the MMRV vaccine, which has been in use for over 15 years without evidence of safety issues [3] - If the MMRV vaccine is not recommended, it could negatively impact Merck's revenue, as the ProQuad vaccine generates approximately $2.5 billion annually for the company [3] Group 4: Thimerosal Controversy - Thimerosal has faced opposition from anti-vaccine advocates who claim it may cause autism, despite the FDA stating it has not been proven to pose safety risks [4] - Robert F. Kennedy Jr. has been a vocal opponent of thimerosal, advocating for its removal from vaccines [4] Group 5: Other Vaccine Discussions - The committee will also discuss the chikungunya vaccine, which is not included in the federal adult immunization schedule and is intended for international travelers [5] - Concerns have been expressed that the actions of anti-vaccine committee members are undermining public trust in vaccines and the healthcare system [5]
Sanofi Trades Below 50 & 200-Day Moving Averages: Time to Buy the Dip?
ZACKS· 2025-06-24 15:01
Core Viewpoint - Sanofi's stock has been underperforming, trading below its 50-day and 200-day moving averages, raising concerns among investors about its future direction [1][2][8]. Group 1: Dupixent and Vaccine Segment - Dupixent, developed in partnership with Regeneron, is a significant revenue driver for Sanofi, approved for multiple inflammatory diseases and expected to generate around €22 billion in sales by 2030 [3][4]. - Sanofi's vaccine segment has shown strong performance, with annual sales exceeding €5 billion and a 13.5% sales growth at constant exchange rates (CER) in 2024, driven by the successful rollout of Beyfortus [5][12]. Group 2: New Products and Pipeline - Sanofi's new products, including Altuviiio and Beyfortus, are contributing to revenue growth, with Beyfortus achieving blockbuster status in its first year [6][7]. - The company has a robust pipeline with 12 potential blockbuster assets in phase III development, including amlitelimab and tolebrutinib [9][10]. Group 3: Financial Performance and Valuation - Sanofi's stock has increased by 3.1% year-to-date, outperforming the industry and S&P 500, with a price/earnings ratio of 10.15, lower than the industry average of 14.81 [14][17]. - Earnings estimates for 2025 and 2026 have risen, reflecting positive momentum from new product launches and pipeline developments [20][24]. Group 4: Challenges and Strategic Moves - The launch of generic versions of Aubagio has negatively impacted its sales, and the influenza vaccine segment is facing competitive pressures [11][12][22]. - Sanofi is actively pursuing mergers and acquisitions to enhance its pipeline, with recent proposed acquisitions of Blueprint Medicines and Vigil Neuroscience [23].
Slowing Gardasil Sales Hurt MRK's Top Line: Is Recovery in the Cards?
ZACKS· 2025-06-17 19:41
Core Insights - Merck's Gardasil vaccine, crucial for preventing HPV-related cancers, has seen a significant decline in sales, particularly in China, leading to a revised sales outlook [1][2][9] - The company has temporarily halted Gardasil shipments to China to manage high inventory levels, impacting its long-term sales guidance [2][9] - Despite challenges in China, Gardasil sales remain strong in other major markets, although global growth is expected to slow [3] Sales Performance - Gardasil sales fell 40% year-over-year to $1.33 billion in Q1 2025, with a 3% decline to $8.58 billion in 2024 [1][9] - The economic slowdown in China has led to elevated inventory levels, prompting Merck to pause shipments [2][9] Market Competition - Merck's new monoclonal antibody, Enflonsia, for RSV prevention is set to launch in the U.S. but will face competition from AstraZeneca/Sanofi's Beyfortus, which achieved blockbuster status in its first year [5][6] - Other RSV vaccines, including Pfizer's Abrysvo and GSK's Arexvy, have also been approved, increasing competitive pressure [6][7] Valuation and Estimates - Merck's shares have underperformed, losing 17.8% year-to-date compared to a 2.6% industry increase [8] - The company's price/earnings ratio stands at 8.79, significantly lower than the industry average of 15.63 [10] - Consensus earnings estimates for 2025 and 2026 have been revised downwards, indicating a potential decline in profitability [11]
Merck Secures FDA Nod for New RSV Antibody Enflonsia in Infants
ZACKS· 2025-06-10 15:51
Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]