Welcome to our dedicated page for Amphastar Pharma news (Ticker: AMPH), a resource for investors and traders seeking the latest updates and insights on Amphastar Pharma stock.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) is a biopharmaceutical company focused on technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products. The AMPH news feed on Stock Titan brings together the company’s press releases and market-moving updates so readers can follow how its product portfolio, licensing deals, and financial performance evolve over time.
News about Amphastar often centers on regulatory milestones and pipeline progress. The company has reported U.S. Food and Drug Administration approval of its ANDA for Iron Sucrose Injection, USP, a generic iron sucrose injection indicated for iron deficiency anemia in chronic kidney disease. It also issues updates on its ANDAs, biosimilar insulin candidate, and proprietary peptide and protein products, including licensed peptide assets targeting oncology and ophthalmology.
Another recurring theme in AMPH news is strategic licensing and research agreements. Amphastar has announced exclusive license agreements with Nanjing Anji Biotechnology Co., Ltd. and Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for proprietary peptide products and for AMP-110, a fully synthetic ACTH analog in early-phase human clinical development. The company also discloses contract research agreements for recombinant peptide research cell banks supporting its pipeline.
Investors can also track quarterly earnings releases, non-GAAP financial metrics, and share repurchase authorizations, as well as announcements about expanded manufacturing capacity and distribution partnerships, such as the exclusive distribution of BAQSIMI® in parts of the Greater China region. By following AMPH news, readers gain insight into Amphastar’s mix of complex generics, proprietary medicines, manufacturing footprint, and related-party agreements that shape its long-term business profile.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) announced a restructuring of its Chinese subsidiary, Amphastar Nanjing Pharmaceuticals Inc. (ANP), which includes buying back 26% of ANP's equity from third parties for approximately $29 million. Concurrently, ANP will spin off its subsidiary, Nanjing Hanxin Pharmaceutical Technology Co., Ltd., retaining a 20% stake. This move aims to enhance Amphastar's control over API manufacturing, with expected EPS accretion of $0.03 in 2021 and $0.12 in 2022. The restructuring is pending regulatory approval and is set to close in Q3 2021.
Amphastar Pharmaceuticals reported net revenues of $103.0 million for Q1 2021, a 22% increase from Q1 2020. GAAP net income was $5.0 million, or $0.10 per share. Adjusted non-GAAP net income reached $13.6 million, or $0.27 per share. Key growth drivers included the launch of glucagon, along with strong sales of Primatene Mist® and epinephrine products. Operating cash flow was $22.8 million, reflecting robust business activity. The company is expanding its product pipeline, with five ANDAs and several proprietary products in development.
Amphastar Pharmaceuticals (NASDAQ: AMPH) announced FDA approval for its Morphine Sulfate injection 1mg/mL in a 30mL Pump-Jet Prefilled Syringe System. The product is intended for severe pain management via Patient-Controlled Analgesia (PCA). In 2020, Morphine injection generated net revenues of $2.3 million. The company has five ANDAs, three biosimilars, and seven generics in development, with combined market potentials of $2.4 billion, $13 billion, and $10 billion respectively. Amphastar also operates with 17 Drug Master Files in the FDA, focusing on complex pharmaceutical products.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will announce its first quarter 2021 financial results on May 6, 2021, after market close. A conference call to discuss these results is scheduled for 2:00 p.m. Pacific Time. The company specializes in developing and selling complex generic and proprietary pharmaceutical products, primarily for hospital and urgent care settings. Interested parties can access the call by dialing in or via the company's website.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in an Analyst-Moderated fireside chat at the Needham Virtual Healthcare Conference on April 13, 2021, at 3:45 PM ET. Key executives, including CFO Bill Peters and VP of Corporate Communications Dan Dischner, will speak during the session. The presentation will be available via webcast on the company's website for 90 days post-event. Amphastar specializes in developing and marketing technically-challenging generic and proprietary injectable and inhalation products, primarily for hospital settings.
Amphastar Pharmaceuticals (NASDAQ: AMPH) announced FDA approval for its Dextrose injection 50% in a 50 mL prefilled syringe. Previously marketed under the 'grandfather' clause, the product generated net revenues of $7.6 million in 2020. This approval allows Amphastar to address drug shortages, enhancing its manufacturing reputation. The company has several ANDAs and biosimilars in progress, targeting a cumulative market size of approximately $25 billion. CEO Dr. Jack Zhang emphasized the commitment to product quality and market needs.
Amphastar Pharmaceuticals reported net revenues of $95.9 million for Q4 2020, up 15% year-over-year. Despite a GAAP net loss of $6.3 million or $0.13 per share, the company posted adjusted non-GAAP net income of $8 million, translating to $0.16 per share. For the full year, revenues reached $349.8 million, a 9% increase, with a GAAP net income of $1.4 million. Growth was driven by Primatene Mist® and epinephrine sales following recent product approvals. The firm remains optimistic for 2021, buoyed by a strong pipeline and recent FDA approvals.
Amphastar Pharmaceuticals (NASDAQ: AMPH) will announce its fourth quarter 2020 financial results on March 15, 2021, after market close. A conference call is scheduled for 2:00 PM PT to discuss the results. Amphastar specializes in developing and selling generic and proprietary injectable and inhalation products used primarily in hospital settings. The announcement includes forward-looking statements regarding financial performance, market growth, and the potential impacts of COVID-19 on operations.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in the Analyst-Moderated fireside chat at the Raymond James 2021 Institutional Healthcare Conference on March 2, 2021, at 1:20 PM Eastern Time. The event features key executives, including CFO Bill Peters and Sr. VP Tony Marrs. A webcast of the presentation will be available on the company's website for 90 days post-event. Amphastar specializes in developing and selling generic and proprietary injectable products, primarily for hospital settings. Further details about the company can be found on their website.
Amphastar Pharmaceuticals (NASDAQ: AMPH) received FDA approval for its Glucagon for Injection Emergency Kit, 1 mg, marking the first FDA approval of a generic version of rDNA Glucagon. This product is indicated for severe hypoglycemia treatment and is bioequivalent to Eli Lilly's product. U.S. sales for Eli Lilly’s Glucagon Emergency Kit were approximately $144 million. Amphastar plans to launch the product within two months. The company has multiple ANDAs filed, targeting a market size of about $1.4 billion, with additional biosimilars and generics in development.