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Amphastar Pharmaceuticals, Inc. is a bio-pharmaceutical company engaged in the development, manufacturing, marketing, and sale of generic and proprietary injectable, inhalation, and intranasal products, as well as insulin active pharmaceutical ingredient (API) products. The company specializes in technically challenging pharmaceuticals and offers a diverse portfolio of over 25 products, including prescription drugs and one over-the-counter product. Amphastar focuses on products with high technical barriers to entry, leveraging proprietary research and development capabilities.
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Finished Pharmaceutical Products - Develops and markets injectable, inhalation, and intranasal drugs, including BAQSIMI®, Primatene MIST®, epinephrine, glucagon, lidocaine, phytonadione, enoxaparin, and naloxone.
- BAQSIMI® - Nasally administered glucagon for severe hypoglycemia.
- Primatene MIST® - Over-the-counter epinephrine inhaler using patented hydrofluoroalkanes (HFA) formulation.
- Naloxone Hydrochloride Nasal Spray (REXTOVY™) - FDA-approved treatment for opioid overdose.
- Albuterol Sulfate Inhalation Aerosol - FDA-approved bronchodilator for asthma and other respiratory conditions.
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Active Pharmaceutical Ingredient (API) Products - Manufactures recombinant human insulin API and porcine insulin API for external customers and internal product development.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Jack Yongfeng Zhang ExecutiveBoard | Chief Executive Officer | Jack Yongfeng Zhang, Ph.D., has served as the Chief Executive Officer of Amphastar Pharmaceuticals since 1996 and is a founding member who holds multiple key roles including President and Chief Scientific Officer. His leadership has been pivotal in shaping the company's strategy and growth. | View Report → | |
Mary Ziping Luo ExecutiveBoard | Chief Operating Officer | Mary Ziping Luo has served as the Chief Operating Officer and Chairman of the Board of Directors at AMPH since its inception in 1996. She also holds the role of Chief Scientist since 2005, underscoring her long-term leadership and expertise in the pharmaceutical industry. | ||
William J. Peters ExecutiveBoard | Chief Financial Officer, Executive Vice President of Finance, and Treasurer | William J. Peters has served as the CFO, Executive Vice President of Finance, and Treasurer at Amphastar Pharmaceuticals since May 2021. He also serves as President of International Medication Systems since March 2016 and as a Board Director since August 2022. | ||
Jacob Liawatidewi Executive | Executive Vice President of Sales and Marketing | Jacob Liawatidewi is the Executive Vice President of Sales and Marketing at Amphastar Pharmaceuticals since May 2020. He has also served as Corporate Secretary since June 2013 and as a Director on the Board since August 2022. | ||
Rong Zhou Executive | Senior Executive Vice President of Production Center | Rong Zhou has served as Senior Executive Vice President of Production Center at Amphastar Pharmaceuticals since February 2023. He previously held executive roles such as Executive Vice President of Scientific Affairs and President of Armstrong Pharmaceuticals, showcasing extensive leadership within the company. | ||
Diane G. Gerst Board | Board of Directors | Diane G. Gerst has served on Amphastar’s Board of Directors since June 2019. She previously held several executive roles at Amphastar, including Executive Vice President of Quality Assurance and Regulatory Affairs from June 2015 to February 2018 and President of Amphastar Nanjing Pharmaceuticals Inc. from March 2014 to February 2018. | ||
Floyd F. Petersen Board | Member of the Board of Directors | Floyd F. Petersen has been a member of the Board of Directors at Amphastar Pharmaceuticals since August 2004 and is also a member of the Compensation Committee. He has an extensive background in academia, consulting, and public service. | ||
Gayle Deflin Board | Director | Chief Financial Officer of LBMB, Inc. | Gayle Deflin has served as Director and Chair of the Audit Committee at Amphastar Pharmaceuticals since June 2021. Previously, she has been the Chief Financial Officer of LBMB, Inc. since 2014. | |
Howard Lee Board | Member of the Board of Directors | Chairman and CEO of TAHO Pharmaceuticals, Ltd. | Howard Lee has served as a board member at AMPH since August 2007. He previously served on the board of IMS from 1998 to 2002 and on AMPH's Board of Directors from 2002 to 2004. | |
Michael A. Zasloff Board | Member of the Board of Directors | Director and Chief Scientific Officer at Enterin, Inc (since 2016) ; Director at BAZ Therapeutics (since 2023) ; Professor of Surgery and Pediatrics at Georgetown University School of Medicine (2002–Present) ; Scientific Director of the MedStar-Georgetown Transplant Institute (Current Role) | Michael A. Zasloff has served on AMPH's Board of Directors since October 2005 and was the Lead Independent Director from January 2016 to April 2019. He is actively involved in key committee work at AMPH while also holding significant external roles in biopharmaceutical companies and academia. | |
Richard Prins Board | Lead Independent Director | Director at IGC Pharma, Inc. (since 2007) ; Chairman of the Board at IGC Pharma, Inc. (since 2012) ; Lead Investor and Chairman at EPH4, LLC | Richard Prins has served as the Lead Independent Director at Amphastar Pharmaceuticals since April 2019 and has been a member of the Board of Directors since February 2002. He is a seasoned professional in corporate finance and investment banking with broad governance experience. |
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Given the anticipated single-digit growth for Primatene Mist alongside declining glucagon sales due to competition, how will management balance these opposing trends while mitigating margin compression?
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With the recent transition of BAQSIMI distribution responsibilities to a significantly larger MannKind sales force, what processes are in place to ensure a smooth rollout, and how might this impact overall profitability and market share?
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Considering the multiple pipeline candidates (AMP-007, AMP-018, AMP-015, and AMP-002) with staggered GDUFA dates and inherent regulatory risks, how are these uncertainties being factored into your near-term guidance?
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Epinephrine sales have declined amidst heightened competition, yet the company remains the sole player in the prefilled syringe market; what concrete steps will management take to defend this market position and prevent further erosion of margins?
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With significant capital spending planned for facility expansion and increased R&D investments, how does management plan to ensure these expenditures deliver risk-adjusted returns and align with the overall long-term growth strategy?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company faces significant competition from pharmaceutical companies that focus on proprietary and generic injectable and inhalation markets, which may adversely affect its market share, revenue, and gross profit from its products. | |
BPI Labs | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has increased competition in the industry. |
Lupin Pharmaceuticals, Inc. | Competition in the generic pharmaceutical industry has increased as producers of branded products have entered the business by creating generic drug subsidiaries or licensing their products to generic manufacturers. |
The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may impact its market share and profitability. | |
Fresenius Kabi USA | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has intensified competition in the industry. |
Apotex Corp. | The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may affect its market share and profitability. |
American Regent Inc. | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has increased competition in the industry. |
Hikma Pharmaceuticals USA, Inc. | The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may impact its market share and profitability. |
Par Pharmaceuticals | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has intensified competition in the industry. |
Cipla USA Inc. | The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may affect its market share and profitability. |
Meitheal Pharmaceuticals | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has increased competition in the industry. |
The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may impact its market share and profitability. | |
The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has intensified competition in the industry. | |
Medefil Inc. | The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may affect its market share and profitability. |
Accord Healthcare | The company competes with other pharmaceutical companies in the generic injectable and inhalation markets, which has increased competition in the industry. |
Teva Pharmaceutical USA Inc. | The company faces competition from other pharmaceutical companies in the generic injectable and inhalation markets, which may impact its market share and profitability. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
BAQSIMI | 2024 | Acquired as an asset acquisition by Amphastar with a total purchase price of $628.1 million (primarily allocated to BAQSIMI product rights) that includes a deferred cash payment of $129 million due in June 2024 and potential for up to $575 million in contingent cash payments; the deal also involves transition and manufacturing services agreements (up to 18 months) to support clinical, regulatory, and supply chain operations. |
Recent press releases and 8-K filings for AMPH.
- Amphastar Pharmaceuticals showcased its integrated business model with strong R&D investments, reporting revenue growth from $350M in 2020 to $732M in 2024 and improving net income margins (27.3% in 2023 and 27.4% in 2024) .
- The presentation emphasized a strategic focus on complex generic injectables and biosimilars, leveraging legacy products like glucagon while transitioning to proprietary offerings .
- BAQSIMI delivered impressive performance, outperforming expectations and entering a copromote agreement with MannKind to further boost growth .
- The company highlighted rising Primatene MIST sales, having surpassed the $100 million milestone .
- The update detailed robust pipeline prioritization, including progress on a first-cycle inhalation product, addressing a teriparatide CRL, and expanding into biosimilar insulin products to capture significant market opportunities .
- Forward-looking statements outlined upcoming regulatory milestones and sales projections, reinforcing anticipated growth from emerging products and strategic pipeline expansions .
- Strong Financials: Reported Q4 net revenues of $186.5 million and FY net revenues of $732.0 million; GAAP net income of $38.0 million in Q4 ($0.74/share) and $159.5 million for FY 2024 ($3.06/share), with adjusted non-GAAP results of $47.2 million in Q4 and $200.8 million for FY 2024, and an adjusted margin of 27.4% .
- Key Product Contributions: Primatene Mist achieved $102M in annual sales with increased unit volumes, while BAQSIMI delivered robust performance via 12% factory sales growth, a 3% price increase, and an expanded sales force through collaboration with MannKind .
- Pipeline & Regulatory Dynamics: Multiple ANDA filings (AMP-007, AMP-015, AMP-018) are progressing with upcoming GDUFA dates, although increased competition impacted glucagon and epinephrine sales .
- R&D & Global Expansion: Over $351M in self-funded R&D investments is driving pipeline advancements and expansion into 26+ countries .
- Forward-Looking Guidance: Management outlined uncertainties and risks related to future financial performance, regulatory approvals, and product launch timelines .
- Presentation includes extensive forward-looking statements for FY2025, underpinned by strong historical financial performance with revenue growing from $295M to $644M (2018–2023) .
- Highlights a diversified product pipeline featuring BAQSIMI and Primatene MIST, supported by ~$345 million in self-funded R&D over the past 5 years .
- BAQSIMI’s performance remains robust with a peak sales forecast of $250–275 million as it expands into 26 countries with strengthened global distribution and the MannKind collaboration .
- Emphasizes an integrated business model and dual growth strategy focused on in‑house R&D, full-cycle manufacturing, organic pipeline development, and strategic acquisitions .
- Shares key operational updates including over $100 million in Primatene MIST sales and addressing supply chain/regulatory challenges, notably the nearly 2‑year AMP‑002 delay with plans to resolve FDA concerns .