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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, 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.
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.
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