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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]
Can Biogen Stock Rebound as New Drugs Aim to Offset MS Sales Declines?
ZACKS· 2025-10-10 16:56
Core Insights - Biogen's key multiple sclerosis (MS) drugs, including Tecfidera and Tysabri, along with the spinal muscular atrophy (SMA) treatment Spinraza, are experiencing declining sales due to increased competition, impacting overall revenue growth [1][3][10] Sales Performance - Sales of Tecfidera are declining due to the launch of multiple generic versions in North America, Brazil, and certain European countries [3] - Tysabri's sales are also declining as a result of heightened competition in the U.S. and the introduction of biosimilars in Europe, with a U.S. biosimilar expected by Q4 2025 [3][4] - Spinraza's revenues are anticipated to be lower in the second half of the year due to unfavorable shipment timing and competition from Novartis' Zolgensma and Roche's Evrysdi [5] New Drug Developments - Biogen's collaboration with Eisai on Leqembi for Alzheimer's disease shows potential for long-term growth, with sequential sales improvements noted over the past four quarters [6][10] - Leqembi has been launched in multiple countries and is expected to generate significant sales due to the unmet need in Alzheimer's treatment [7] - Skyclarys is witnessing strong demand trends, particularly in the U.S. and EU, with ex-U.S. sales projected to become a more significant growth driver in 2025 [9] Financial Outlook - Biogen's total revenues rose by 7% in the first half of 2025, driven by new drug sales, although the overall revenue for 2025 is projected to remain flat compared to 2024 [11][12] - The contribution from new drugs is increasing, but it is not yet sufficient to offset the declining revenues from MS drugs and Spinraza [12] Valuation and Estimates - Biogen's stock has declined by 2.2% this year, contrasting with an 8.7% increase in the industry [13] - The company's shares are trading at a forward price/earnings ratio of 9.49, lower than the industry average of 15.88 and its own 5-year mean of 13.55 [15] - The Zacks Consensus Estimate for 2025 earnings has increased from $14.87 to $15.68 per share over the past 90 days [16]
Can Galafold Drive Amicus' Growth Through the Rest of 2025?
ZACKS· 2025-10-02 14:41
Core Insights - Amicus Therapeutics' lead product, Galafold, is the primary revenue driver for the company, being the first oral precision medicine approved for Fabry disease treatment [1][2] - Galafold sales reached $233.1 million in the first half of 2025, reflecting an 11% year-over-year increase, with a projected CAGR of 11.7% over the next three years [2][9] - The company has secured strong patent protection for Galafold in the U.S. until 2038, following a licensing agreement with Teva Pharmaceuticals that prevents generic competition until January 2037 [3][4][9] Product Performance - Galafold has shown consistent sales growth since its launch, with label expansions and approvals in new regions contributing to its revenue increase [2][3] - The combination therapy Pombiliti + Opfolda for late-onset Pompe disease generated $46.8 million in sales during the first half of 2025, marking a 74% year-over-year increase [5] Market Dynamics - Amicus is heavily reliant on Galafold for revenue, which poses risks if regulatory challenges arise [6] - The company faces significant competition from established players in the lysosomal storage disorder market, including Sanofi and Takeda Pharmaceuticals, which market products for Fabry and Pompe diseases [7][8]
Innovent's weight-loss drug highlights China challenge for Novo, Lilly
Reuters· 2025-09-22 23:03
Core Insights - Innovent Biologics has launched a new weight-loss drug that is gaining traction in the Chinese market, intensifying competition with Western counterparts [1] - The company's marketing strategy is proving effective, leading to increased market penetration and consumer interest [1] Company Summary - Innovent Biologics is focusing on the weight-loss drug segment, which is becoming increasingly competitive in China [1] - The company aims to leverage its marketing strategy to differentiate itself from Western competitors [1] Industry Summary - The weight-loss drug market in China is experiencing growth, with local companies like Innovent Biologics challenging established Western firms [1] - The competitive landscape is shifting as domestic players enhance their marketing efforts and product offerings [1]
Can BIIB's New Drugs Revive Growth as Multiple Sclerosis Sales Fall?
ZACKS· 2025-03-14 14:40
Core Insights - Biogen's key multiple sclerosis drugs, including Tecfidera and Tysabri, along with Spinraza for spinal muscular atrophy, are facing declining sales due to increased competition, leading to a 2% decline in total revenues in 2024, with a projected mid-single-digit percentage decline in 2025 [1][4][6] Group 1: Revenue Declines - Biogen's global MS revenues declined by 7% in 2024, with expectations of a steeper decline in 2025 due to the potential entry of Tysabri biosimilars in the U.S. and generic versions of Tecfidera in Europe [4] - Spinraza sales fell nearly 10% in 2024, attributed to competitive pressure and decreased demand, with little improvement anticipated in 2025 [4][10] Group 2: Competitive Landscape - The launch of multiple generic versions of Tecfidera in North America, Brazil, and Europe has negatively impacted its revenues [3] - Regulatory approvals for biosimilars of Tysabri in the U.S. and Europe are contributing to the competitive pressure faced by Biogen [3][5] Group 3: New Drug Potential - Biogen is optimistic about new drugs like Leqembi for Alzheimer's, Skyclarys for Friedreich's ataxia, and Zurzuvae for depression, which are seen as potential drivers for long-term growth [2][8] - Leqembi has shown sequential improvement in sales since its launch, with expectations for continued growth in 2025 [7][8] Group 4: Market Challenges - The FDA approval of Eli Lilly's Alzheimer's drug Kisunla poses significant competition to Leqembi [5] - Foreign exchange headwinds are expected to negatively impact 2025 revenues by 1%, alongside a projected $50 million to $100 million impact from the redesign of Medicare Part D [6] Group 5: Pipeline Developments - Biogen faced setbacks in its pipeline, including the discontinuation of Zurzuvae's development for major depressive disorder, which had a larger market potential than its current indication [5] - The acquisition of Reata Pharmaceuticals added Skyclarys to Biogen's portfolio, which is experiencing strong launch trends [9]