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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) 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.
Amphastar Pharmaceuticals reported net revenues of $83.4 million for Q3 2020, a 4% increase year-over-year. GAAP net income rose to $3.9 million, or $0.08 per share, while adjusted non-GAAP net income reached $7.6 million, or $0.15 per share. Key contributors to revenue growth included strong sales from Primatene Mist® and the successful re-launch of the epinephrine vial. The company remains focused on product development with five ANDAs targeting $1.5 billion market and three biosimilars targeting $13 billion in the pipeline.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will announce its third quarter 2020 financial results on November 6, 2020, before market opening. A conference call will follow at 9:00 a.m. Pacific Time to discuss the results. Amphastar specializes in developing and marketing generic and proprietary injectable and inhalation products, primarily for hospital use. The company emphasizes its commitment to high-quality products with technical barriers and operates mainly through group purchasing organizations and wholesalers.
Amphastar Pharmaceuticals announced FDA approval for Atropine Sulfate injection 0.1mg/mL in a 10 mL Prefilled Syringe. This marks a significant shift from being marketed under the 'unapproved' status for 40 years, with 2019 net revenues of $12.2 million. CEO Dr. Jack Zhang emphasized that this approval addresses drug shortages and showcases Amphastar's manufacturing capabilities. The company has four ANDAs filed targeting a market size of $1.5 billion, three biosimilars worth $13 billion, and nine generics totaling $12 billion in development.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will participate in an Analyst-Moderated fireside chat at the Wells Fargo 2020 Virtual Healthcare Conference on September 10, 2020, at 3:20 p.m. ET. Key executives, including CFO Bill Peters, will present. A live webcast will be available on Amphastar’s website and accessible for 90 days. Amphastar focuses on developing injectable and inhalation products, primarily for hospital settings. The company sells insulin active pharmaceutical ingredients and markets its products through wholesalers and group purchasing organizations.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will present at the BMO Prescriptions for Success Healthcare Conference on June 23, 2020, at 1:00 p.m. Eastern Time. The presentation will feature CFO Bill Peters, VP Dan Dischner, and SVP Tony Marrs. Investors can access the live webcast on Amphastar's website, which will be available for 90 days after the event. Amphastar specializes in developing and selling generic and proprietary injectable and inhalation products, primarily for hospital and urgent care settings.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will present at the Raymond James Virtual 2020 Human Healthcare Innovation Conference on June 18, 2020, at 11:40 a.m. ET. Key executives, including CFO Bill Peters, VP Dan Dischner, and SVP Tony Marrs, will participate in the event. The presentation will be available via a live webcast on Amphastar’s website, with access for 90 days post-event. Amphastar specializes in developing and marketing injectable, inhalation, and intranasal pharmaceutical products, primarily for hospital and clinical settings.
Amphastar Pharmaceuticals has received FDA approval for its Succinylcholine Chloride Injection USP (200 mg/10 mL) Multiple-Dose Vial, deemed therapeutically equivalent to Pfizer's Quelicin. This product, with an estimated annual U.S. market of $75 million, is used for muscle relaxation during surgery. The company has five ANDAs aimed at a combined market of $1.7 billion and is developing three biosimilars and nine generics targeting around $25 billion in potential sales. The approval emphasizes Amphastar's regulatory capacity.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) will present at the Jefferies Virtual Healthcare Conference on June 3, 2020, at 4:00 p.m. ET. CFO Bill Peters and VP of Corporate Communications Dan Dischner will lead the presentation, which can be accessed via a live webcast on the company's website. This presentation will remain available for 90 days. Amphastar specializes in developing, manufacturing, and marketing challenging generic and proprietary injectable, inhalation, and intranasal products, primarily for hospital or urgent care use.
Amphastar Pharmaceuticals reported first-quarter 2020 results with net revenues of $84.7 million, a 6% increase from $79.8 million in Q1 2019. GAAP net income reached $3.9 million ($0.08 per share) compared to $0.9 million ($0.02 per share) last year. Adjusted non-GAAP net income was $8.4 million ($0.17 per share), up from $4.9 million ($0.10). Strong sales were driven by Primatene® Mist, which saw a 344% increase. The company continues to develop a robust pipeline with 6 ANDAs and 3 biosimilars targeting markets totaling $24 billion.
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