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Viatris Inc. (VTRS) Gains FDA Approval for First Generic Iron Sucrose Injection
Yahoo Finance· 2025-09-23 23:10
Company Overview - Viatris Inc. (NASDAQ:VTRS) was formed from the 2020 merger of Mylan and Pfizer's Upjohn division, delivering essential generic and specialty medicines to patients in over 165 countries [1] - The company maintains a broad portfolio across multiple therapeutic areas, focusing on sustainable growth, operational discipline, and shareholder returns [1] Recent Developments - In September 2025, Viatris achieved FDA approval for its first generic Iron Sucrose Injection, a complex generic version of Venofer, which is intended for iron deficiency anemia in chronic kidney disease patients [2] - The injection is available in three strengths, with two awarded Competitive Generic Therapy designation, granting 180 days of market exclusivity [2] - Venofer generates $515 million in annual U.S. sales, and this approval significantly strengthens Viatris' injectable portfolio [2] Financial Performance - Viatris reported strong Q2 2025 results, with revenues of $3.58 billion and adjusted EPS of $0.62, exceeding expectations while maintaining top-half guidance for the year [3] - The firm returned over $630 million to shareholders year-to-date, including $350 million in share buybacks [3] Research and Development - Pipeline progress includes positive outcomes from five Phase 3 studies, notably in ophthalmic solutions for night vision impairment and presbyopia, supporting upcoming FDA submissions [3] - Presentations at PAINWeek 2025 highlighted Viatris' R&D capabilities and commitment to clinical innovation in pain management [4] Leadership Changes - Andrew Enrietti was appointed Chief Administrative and Transformation Officer, and David Simmons joined the board to strengthen strategic oversight [4]
12 Cheap Healthcare Stocks to Buy Now
Insider Monkey· 2025-09-15 11:35
Core Viewpoint - The healthcare industry is currently facing significant challenges, with large-cap pharmaceutical companies particularly affected, leading to a poor performance compared to the market [2][3]. Group 1: Industry Challenges - The healthcare sector has only outperformed the market during downturns over the last decade, indicating a troubling trend [2]. - The current dynamics in the healthcare industry are described as the worst experienced in decades, with managed care and pharmaceuticals identified as the main contributors to market pressures [3]. Group 2: Investment Opportunities - A methodology was employed to identify cheap healthcare stocks, focusing on companies with a market capitalization above $2 billion and a forward P/E ratio below 15 [5]. - The article lists 12 healthcare stocks deemed attractive for investment, based on their valuation metrics and growth potential [6]. Group 3: Company Highlights - **Bausch Health Companies Inc. (NYSE:BHC)**: - Forward P/E Ratio: 1.45, recognized for strategic acquisitions and pipeline developments, particularly in hepatology [7]. - Recent acquisition of DURECT Corporation valued at $63 million upfront, with potential milestone payments of up to $350 million, enhancing its portfolio for alcoholic hepatitis [8]. - Key pipeline assets include larsucosterol and rifaximin SSD, with significant market potential in addressing hospitalizations for alcoholic hepatitis [9][10]. - **Organon & Co. (NYSE:OGN)**: - Forward P/E Ratio: 2.73, focused on women's health and biosimilars, expanding its market presence since spinning off from Merck [11]. - Recent FDA approvals for biosimilars BILDYOS and BILPREVDA, aimed at improving access to osteoporosis and bone cancer treatments [12]. - The company is pivoting towards biosimilars as a growth engine while maintaining focus on women's health and dermatology [13]. - **Viatris Inc. (NASDAQ:VTRS)**: - Forward P/E Ratio: 4.40, formed from the merger of Mylan and Pfizer's Upjohn division, focusing on generics and specialty pharmaceuticals [14]. - FDA approval of a generic iron sucrose injection, reflecting a strategic entry into the intravenous iron market with significant sales potential [15]. - Positive late-stage trial results for several pipeline assets, reinforcing the company's growth strategy and upcoming product launches [16][17].
Amphastar Secures FDA Nod For Iron Sucrose Injection, Analysts Eye Major Sales Momentum
Benzinga· 2025-08-12 17:38
Core Viewpoint - The FDA has approved Amphastar Pharmaceuticals' Iron Sucrose Injection, which is expected to generate significant sales in the treatment of iron deficiency anemia in patients with chronic kidney disease [1][5]. Group 1: FDA Approval and Market Potential - Amphastar Pharmaceuticals received FDA approval for its Iron Sucrose Injection in various dosages, which is indicated for treating iron deficiency anemia in chronic kidney disease patients [1]. - The U.S. sales for the branded competitor, Venofer, were approximately $513 million for the 12 months ending June 30, 2025, indicating a substantial market opportunity for Amphastar [3]. - Analyst estimates suggest that Amphastar's product could capture about two-thirds of the Venofer market, potentially leading to sales of $80 million to $100 million [5]. Group 2: Financial Performance and Analyst Ratings - Amphastar reported adjusted earnings of 85 cents, surpassing the consensus estimate of 76 cents, while sales fell 4% year-over-year to $174.41 million, slightly above the consensus of $174.25 million [7]. - Analyst Serge Belanger upgraded Amphastar to a Buy rating from Hold, with a price forecast of $36, citing attractive valuation and growth potential for 2025 and 2026 [6]. Group 3: Strategic Partnerships and Future Developments - Amphastar announced an exclusive license agreement with Nanjing Anji Biotechnology to develop and commercialize three proprietary peptides, with potential total payments to Anji reaching up to $453 million [8][9]. - The agreement includes an upfront payment of $5.25 million and additional milestone payments, indicating a strategic move to expand its product portfolio [9].