Amphastar Pharmaceuticals (NASDAQ:AMPH) executives used a conference presentation to highlight the company’s shift toward higher-value proprietary products, while also outlining near-term launch plans across its generic, biosimilar, and branded portfolios. Chief Financial Officer Bill Peters and Chief Executive Officer Jack Zhang said the company is leaning on its vertically integrated model and sustained R&D investment as it transitions away from heavier reliance on traditional generics.
Integrated manufacturing and a “dual growth strategy”
Peters described Amphastar as a “fully integrated” pharmaceutical company with in-house product development, advanced analytical techniques, animal studies, and manufacturing capabilities that include producing several APIs, devices, and components. He said all finished product is manufactured in the United States across three plants, with marketing and distribution capabilities also housed internally.
Pipeline mix shifting toward proprietary products
Peters said Amphastar is intentionally evolving its pipeline composition in response to increased competition in complex generics. Five years ago, he said the pipeline was 63% generic, 21% proprietary, and 16% biosimilar. The company set a goal to reach 50% proprietary products by 2026 and said it is “well on the way” to achieving that target. Amphastar’s stated 2026 goal mix is 50% proprietary, 35% biosimilar, and 15% generic.
Executives also outlined technical platforms supporting development, including particle engineering and novel formulations (citing Primatene Mist), characterization and immunogenicity for peptide and protein products, insulin analogs for BLAs and biosimilar interchangeables, highly purified peptides and proteins (including glucagon), and novel devices such as the dry powder inhalation system used for Baqsimi.
R&D investment and proprietary R&D focus
Zhang said Amphastar has consistently spent roughly $60 million to $75 million per year on research and development. He highlighted four peptide-focused, proprietary programs discussed as NDA new chemical entities:
- AMP-105: an oncology product described as having a potentially novel mechanism targeting cell growth and metastasis inhibition, with early studies showing broader anti-tumor activity.
- AMP-107: described as a “first non-injectable anti-VEGFR eye drop,” double-targeted to VEGFR and integrin alpha-v beta-3, aimed at reducing treatment burden and improving compliance for wet AMD or DME. Zhang cited a 2024 market size estimate of $9.4 billion and said there are “two to three million” patients with wet AMD or DME.
- AMP-109: a peptide drug conjugate (PDC) with docetaxel, which Zhang said is intended to improve safety by reducing toxicity while improving efficacy.
- AMP-110: a novel synthetic human corticotropin (ACTH) product described as highly purified; Zhang said phase 1 clinical development has been completed.
Zhang also discussed preclinical results for AMP-109 in a xenograft mouse model, citing inhibition rates up to 99.6% in a high-dose group and stating that in one study nine of 10 mice treated with high-dose AMP-109 had pancreatic cancer that “disappeared” and could not be observed. For AMP-110, Zhang described animal model results showing dose-dependent reductions in measured events, including reductions to zero at a higher dose in the examples presented.
Upcoming launches: AMP-007 mid-2026, biosimilar insulin aspart in 2027
Peters reviewed Amphastar’s biosimilar and generic pipeline and said teriparatide was approved at the end of December and has launched. He said AMP-007, a metered dose inhaler product, is expected to launch in mid-2026 and could be the first generic in its market because “there’s no generics on the market yet.” He also referenced additional inhalation products AMP-017 and AMP-023.
On the biosimilar side, Peters said AMP-004 (insulin aspart) has been filed, with an expected commercial launch in 2027. AMP-005 is a recombinant human insulin program in development. He said insulin degludec is “probably” being put on hold due to market conditions. Peters also pointed to AMP-028 as a biosimilar where the company believes it has a competitive advantage tied to the API involved.
Management emphasized a diabetes-focused portfolio that spans insulin candidates, a glucagon kit, Baqsimi nasal powder, and a GLP-1 program, with Peters citing $1.7 billion in sales opportunity for the company’s insulin pipeline based on IQVIA measurements.
Baqsimi and Primatene Mist: guidance reiterated, geographic pruning planned
Executives described the acquisition of Baqsimi as transformative, saying it moved Amphastar into proprietary commercial Rx products, helped establish a branded sales team, expanded its international footprint to 26 countries, and strengthened its intranasal delivery portfolio with what Peters called “strong intellectual property protection.” The company reiterated peak sales guidance of $250 million to $275 million.
Peters said Amphastar expects mid-single-digit growth for Baqsimi this year, driven by low double-digit growth in the U.S. while not taking a price increase this year. Internationally, he said the company expects a small decline as it plans to withdraw from “a handful of countries” that are money-losing. He said the obligation to continue supplying certain countries ends at the end of June, and exiting those markets is expected to improve profitability. Peters projected selling expenses at about 15% of Baqsimi sales and said at peak the product could add $2 to $2.50 of incremental EPS.
For Primatene Mist, Peters said it remains the only FDA-approved OTC asthma inhaler and that Amphastar is supporting growth through increased physician sampling and a new commercial. The company is also developing a reformulated version with a “patented green” propellant intended to have lower global warming potential. Peters forecast high single-digit growth for Primatene Mist this year.
In Q&A, Peters characterized 2025 as a “solid execution year,” citing performance from Baqsimi and Primatene Mist, two new launches, and continued manufacturing and pipeline development, while also noting pricing pressure in the generic portfolio and timing-related delays. For 2026, Amphastar adjusted its growth outlook to “mid-single digit to low double digits,” with AMP-007 described as the largest forecast growth driver. Peters also said Amphastar plans to begin selling certain GLP-1 APIs in China to third parties—an evolution from its historical strategy of using that business mainly to supply internal needs.
On Baqsimi, Peters said Amphastar has captured a majority of the prescription market for ready-to-use glucagon and is focused on expanding penetration among insulin users, noting the share of insulin patients filling a glucagon prescription rose from 10% at acquisition to 12%.
Asked about competition for Primatene Mist after patent expiration, Peters said the company was not aware of active generic development but argued the economics may be unattractive for a challenger given OTC substitution dynamics. He also said Amphastar has an issued patent tied to the new propellant formulation.
Finally, on business development, Peters said he does not expect another “transformational” deal like Baqsimi, but the company could consider smaller acquisitions or licenses—potentially later-stage or commercial—especially in areas aligned with its capabilities in injectables, inhalation, and intranasal delivery, as well as endocrinology, ophthalmology (including wet AMD), and, to a lesser extent, oncology.
About Amphastar Pharmaceuticals (NASDAQ:AMPH)
Amphastar Pharmaceuticals, Inc is a specialty pharmaceutical company headquartered in Rancho Cucamonga, California. Founded in 2004, Amphastar focuses on the development, manufacturing and commercialization of injectable and inhalation products. The company’s manufacturing facilities in California produce both generic and proprietary formulations designed to address urgent and chronic medical conditions.
Amphastar’s portfolio includes a range of injectable generics such as epinephrine, naloxone and lidocaine, serving hospital, emergency medical and retail pharmacy channels.
