Welcome to our dedicated page for Amphastar Pharmaceuticals news (Ticker: AMPH), a resource for investors and traders seeking the latest updates and insights on Amphastar Pharmaceuticals stock.
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) is a specialty pharmaceutical company headquartered in Rancho Cucamonga, California. Established in 1996, Amphastar is known for developing, manufacturing, and marketing injectable and inhalation products using state-of-the-art, cGMP-compliant facilities. The company operates five manufacturing facilities across the United States, China, and Europe, along with a cutting-edge new drug research center.
Amphastar's core business revolves around producing approximately 15 injectable products, with a strong focus on both generic and branded drugs that target large markets with high technical barriers to entry. The company's comprehensive portfolio includes injectable, inhalation, and intranasal products, catering to hospitals and urgent care clinical settings. These products are distributed through group purchasing organizations and drug wholesalers, with the majority of revenue being generated in the United States.
The company leverages its longstanding relationships with major group purchasing organizations and drug wholesalers in the U.S. to establish significant market share quickly. Amphastar's finished pharmaceutical products and Active Pharmaceutical Ingredient (API) products are divided into two main segments: Finished Pharmaceutical Products and API Products.
Recent achievements for Amphastar include the acquisition of commercially successful products like BAQSIMI® and the strategic expansion of their diabetes portfolio. The company reported impressive financial results for the third quarter of 2023, with net revenues of $180.6 million and a GAAP net income of $49.2 million. The strong performance was driven by their diabetes portfolio and the newly acquired BAQSIMI®.
Amphastar's product development pipeline is robust, with multiple ANDAs and biosimilar products targeting significant market opportunities. The company also announced the FDA approval of Albuterol Sulfate Inhalation Aerosol, marking a milestone in their ability to develop complex generic inhalation products. This approval reflects Amphastar’s technological and manufacturing expertise, positioning the company for future growth.
Amphastar's commitment to quality and innovation is further demonstrated by their strategic acquisition and integration activities, focused on maximizing commercial potential and delivering high-quality pharmaceutical solutions. The company continues to enhance its pipeline with both generic and proprietary products, targeting products with large market sizes and high growth potential.
For more information, visit www.amphastar.com.
Amphastar Pharmaceuticals (NASDAQ:AMPH) announced FDA approval for its Epinephrine injection USP, 1 mg/10mL pre-filled syringe, indicated for increasing mean arterial blood pressure in adults with septic shock. This marks the conclusion of the company’s transition from the grandfather exception to NDA approvals for its products, with 2021 net revenues from Epinephrine injection at $27.8 million. Amphastar has several products in development targeting a combined market size of $24.3 billion, indicating significant revenue potential moving forward.
Amphastar Pharmaceuticals (NASDAQ:AMPH) will announce its second-quarter results for the period ending June 30, 2022, after market close on August 8, 2022. A conference call is scheduled for 2:00 p.m. PT to discuss these financial results. Interested parties can access the call by dialing (877) 407-0989 or (201) 389-0921 for international calls, five minutes prior. Amphastar focuses on developing, manufacturing, and selling generic and proprietary biopharmaceutical products, primarily for clinical settings. More information is available on their website.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has received FDA approval for its Vasopressin injection (20 Units/mL, 1mL Single Dose Vial), which is used to increase blood pressure in adults with vasodilatory shock. This approval follows a tentative approval received in December 2021. The total U.S. market for vasopressin injection was approximately $714 million for the 12 months ending March 31, 2022. Amphastar plans to launch the product shortly. The company has several additional products in its pipeline with a combined market potential of approximately $25.3 billion.
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) will present at the Jefferies Healthcare Conference on June 8, 2022, at 8:00 am EST. The presentation will be led by Bill Peters, Executive VP and CFO, and Dan Dischner, VP of Corporate Communications. Investors can access the live webcast on Amphastar's website, which will be available for 90 days post-event. Amphastar specializes in developing and marketing injectable and inhalation products, primarily for urgent care settings.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has received FDA approval for its Regadenoson injection, a critical radiopharmaceutical for myocardial perfusion imaging, particularly for patients unable to exercise adequately. This product positions Amphastar to compete in a market previously dominated by Astellas Pharma's Lexiscan, which had $650 million in U.S. sales over the past year. The commercialization timing is subject to a confidential settlement with Astellas. Amphastar's portfolio includes three ANDAs targeting a $3.3 billion market, three biosimilars worth $13 billion, and eight generics amounting to $9 billion.
Amphastar Pharmaceuticals reported net revenues of $120.4 million for the first quarter of 2022, a 17% increase from $103 million during the same period in 2021. GAAP net income was $24.3 million, or $0.47 per share, significantly up from $5 million last year. Key product sales included a 34% rise in Primatene Mist and a 38% increase in Glucagon. Although API sales decreased by 26%, the overall gross profit rose by 24% to $55.8 million. The board also authorized a $25 million increase to the share buyback program.
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) will announce its first quarter 2022 results on May 9, 2022, after market closure. A conference call to discuss the results is scheduled for 2:00 p.m. Pacific Time. Interested participants can join by dialing (877) 407-0989 (toll-free) or (201) 389-0921 (international) five minutes prior to the call. Amphastar specializes in developing and marketing generic and proprietary injectable, inhalation, and intranasal products, primarily for hospital use. For more information, visit www.amphastar.com.
Amphastar Pharmaceuticals has received FDA approval for its Ganirelix Acetate Injection, a 250mg/0.5mL prefilled syringe, indicated for controlling premature LH surges in women undergoing ovarian hyperstimulation. This marks the company's fourth injectable peptide product approval, with plans for market launch in Q2 2022. The U.S. market for Ganirelix is valued at approximately $89 million as of the end of 2021. Amphastar's pipeline includes four ANDAs targeting a market size of $3.9 billion and several biosimilars and generics, enhancing its market position.
Amphastar Pharmaceuticals (NASDAQ:AMPH) will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022. This event, featuring key executives including Bill Peters and Dan Dischner, is scheduled for 12:45 pm EST. The presentation will be accessible through Amphastar's website and available for 90 days post-event. Amphastar focuses on developing and marketing generic and proprietary injectable products. More details can be found on their website at ir.amphastar.com.
Amphastar Pharmaceuticals (NASDAQ:AMPH) reported net revenues of $120.9 million for Q4 2021, a 26% increase year-over-year. GAAP net income stood at $19.8 million or $0.39 per share. For the fiscal year, revenues totaled $437.8 million, up 25%, with GAAP net income of $62.1 million, reflecting the company's strong performance in higher-margin products like Primatene Mist and epinephrine. The company anticipates further growth with multiple pipeline milestones set for 2022.
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