Welcome to our dedicated page for Amneal Pharmaceuticals news (Ticker: AMRX), a resource for investors and traders seeking the latest updates and insights on Amneal Pharmaceuticals stock.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is a leading global pharmaceutical company headquartered in Bridgewater, NJ. Amneal develops, manufactures, and distributes a diverse portfolio of over 280 generic and specialty pharmaceutical products across the United States, India, and Ireland. With a commitment to providing affordable medicines, Amneal operates through three key segments: Generics, Specialty, and AvKARE.
Generics Segment: This segment focuses on producing a wide range of dosage forms and delivery systems, including injectables and biosimilars, contributing significantly to the company's revenue. The Generics segment is dedicated to expanding across complex product categories and therapeutic areas, ensuring patients have access to vital medications.
Specialty Segment: Amneal's Specialty segment promotes proprietary branded pharmaceuticals targeting central nervous system and endocrine disorders. The segment has a growing portfolio of branded pharmaceuticals with a pipeline focused on addressing unmet medical needs, demonstrating the company's commitment to innovation.
AvKARE Segment: This segment distributes pharmaceuticals and medical products to governmental agencies, specializing in re-packaging and wholesale distribution. AvKARE focuses on offering consistent care and pricing to qualified entities, enhancing access to essential medicines for governmental and institutional markets.
Recently, Amneal has achieved significant milestones, including the resubmission of a Complete Response to the FDA for IPX203, an oral formulation for Parkinson’s disease, and entering a licensing agreement with Zambon Biotech for IPX203 in Europe. The company also launched PEMRYDI RTU®, the first ready-to-use version of pemetrexed for injection, underscoring their commitment to oncology treatment advancements.
Amneal's financial performance remains robust, with net revenue of $2.39 billion in 2023 and a strategic focus on expanding its reach through innovative products and international partnerships. The company continuously invests in research and development to meet the growing demands for affordable and high-quality medications, solidifying its position as a key player in the pharmaceutical industry. For more information, please visit www.amneal.com.
Amneal Pharmaceuticals (AMRX) reported Q3 2022 net revenue of $546 million, a 3.2% increase from $529 million in Q3 2021. The company faced a net loss of $3 million, an improvement from a $4 million loss a year earlier. Adjusted EBITDA fell 5.1% to $126 million. Diluted loss per share was $(0.02) compared to $(0.03) the previous year, while adjusted diluted EPS stood at $0.14. The company is maintaining its full-year guidance, targeting net revenue of $2.15 billion - $2.25 billion.
Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for leuprolide acetate injection, indicated for the palliative treatment of advanced prostatic cancer. The product is expected to contribute to the growth of Amneal's injectables business, which has plans to launch eight new injectables in 2022. According to IQVIA, the annual sales for this product were $81 million for the 12 months ending September 2022, presenting a promising market potential.
Amneal Pharmaceuticals (NYSE: AMRX) has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy. Malki brings over 30 years of experience from Alvotech and Mylan, focusing on quality operations in biosimilars. Toufanian, an FDA veteran, previously directed the Office of Generic Drug Policy. These leadership appointments aim to enhance Amneal's capabilities in biosimilars, complex generics, injectables, and specialty areas, signaling a strategic expansion in high-growth sectors.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) will release its third quarter 2022 financial results on November 4, 2022, before market open. A conference call and live webcast for investors will follow at 8:30 a.m. Eastern Time. Access to the financial results and the live webcast is available on the Investor Relations section of the website. Callers can join by dialing 1 (844) 200-6205 or 1 (929) 526-1599 for international access, using access code 585341.
A replay will be available shortly after the call.
Amneal Pharmaceuticals (NYSE: AMRX) has launched ALYMSYS® (bevacizumab-maly), a new oncology biosimilar referencing Avastin®. This marks Amneal's entry into the rapidly growing $28 billion U.S. biosimilars market. ALYMSYS® aims to enhance access to affordable oncology treatments, especially given that the annual sales for bevacizumab reached $2.4 billion as of July 2022. The company plans to expand its biosimilars portfolio in the future, aligning with its mission for affordable medicines.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced the appointment of Gustavo Pesquin as Executive Vice President, Chief Commercial Officer - Specialty, effective September 6, 2022. Pesquin joins from Sanofi, bringing over 11 years of leadership experience, including roles as North America Head for General Medicines. His expertise is expected to enhance Amneal's growth in the Specialty segment, which focuses on central nervous system and endocrine disorders. The Co-CEOs expressed confidence that his diverse background will drive the company’s next phase of growth.
Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for IPX203, an extended-release formulation of carbidopa/levodopa aimed at improving treatment for Parkinson's disease. Results from the Phase 3 RISE-PD trial showed IPX203 provided an average of 1.55 more hours of 'Good On' time compared to immediate-release formulations, despite being taken less frequently. The formulation aims to address the needs of Parkinson's patients for enhanced motor control and less frequent dosing.
Amneal Pharmaceuticals (NYSE: AMRX) announced its support for the newly formed Congressional Domestic Pharmaceutical Manufacturing Caucus, aimed at ensuring a resilient supply chain of essential medicines manufactured in the U.S.. The caucus, led by a bipartisan group of representatives, seeks to address supply chain vulnerabilities highlighted by the pandemic and geopolitical conflicts. Co-CEOs Chirag and Chintu Patel emphasized the importance of domestic manufacturing for national security and aim for legislative solutions to drive change in pharmaceutical supply chains.
Amneal Pharmaceuticals (NYSE: AMRX) has received FDA approval for four generic products, expanding its essential medicines portfolio. The approved products include vasopressin injection, famotidine for oral suspension, atropine sulfate ophthalmic solution, and clindamycin phosphate topical gel. Together, these products represent a market potential of approximately $784 million. Amneal aims to launch 20-30 generics annually, with this latest approval bringing their year-to-date launches to 16. This strategic move is expected to enhance their position in the generics market.
Amneal Pharmaceuticals (AMRX) reported Q2 2022 net revenue of $559 million, up 5% from Q2 2021. However, the company faced a net loss of $121 million, primarily due to a $263 million charge for antitrust litigation. Adjusted EBITDA was $135 million, a decrease of 6%. Diluted loss per share stood at $(0.80), while adjusted diluted EPS was $0.19. The company revised its 2022 guidance, projecting net revenue of $2.15 billion to $2.25 billion and adjusted EBITDA of $500 million to $520 million.
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