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 (NASDAQ:AMPH) will announce its second quarter 2021 results on August 9, 2021, after market close. A conference call is scheduled for 2:00 PM Pacific Time to discuss these results. The company specializes in developing, manufacturing, and marketing generic and proprietary injectable and inhalation products mainly used in clinical settings. The conference call can be accessed by dialing (877) 407-0989 for domestic calls or (201) 389-0921 for international calls.
Amphastar Pharmaceuticals (NASDAQ: AMPH) announced that key executives will present at the Human Health Innovation Conference on June 22, 2021, at 2:00 PM Eastern Time. The panel includes Bill Peters (CFO), Dan Dischner (VP of Corporate Communications), Tony Marrs (SVP of Regulatory Affairs), and Jacob Liawatidewi (EVP of Corporate Administration). A webcast of the presentation will be accessible on Amphastar's website for 90 days following the event. Amphastar focuses on developing and marketing challenging generic and proprietary injectable products.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in an Analyst-Moderated fireside chat at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 2:30 pm Eastern Time. Key executives, including CFO Bill Peters and VP Dan Dischner, will be present. The event will be webcast and available for 90 days on Amphastar's website. Amphastar specializes in developing and marketing technically challenging generic and proprietary injectable, inhalation, and intranasal products, primarily for hospital use.
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.