Amphastar Pharmaceuticals (NASDAQ:AMPH) executives told investors at the Jefferies Healthcare Conference that the company is maintaining expectations for mid- to high-single-digit revenue growth in 2026, supported by a new generic launch, Primatene Mist growth and selected API sales from its China business.
Bill Peters, chief financial officer of Amphastar, said the company continues to build on its base in complex generic and hospital injectable products while expanding into proprietary and biosimilar medicines. Peters said Amphastar has about a half-dozen proprietary products and three biosimilars in development, using experience gained from complex generics, peptides, clinical trials and human factors studies.
Generic Atrovent Launch Seen as Key Growth Driver
Executives said the company’s generic ipratropium bromide product, a generic version of Atrovent, is expected to be the largest driver of revenue growth this year. Amphastar launched the product in mid-April and, according to Jacob Liawatidewi, executive vice president of corporate administration, is currently the only generic on the market.
Liawatidewi said Amphastar successfully brought the product through a Paragraph IV challenge and has six months of exclusivity, which he said runs until Oct. 6. He added that the company has not heard of other ANDA filers, though that does not mean none exist. Based on Amphastar’s development work, Liawatidewi said the product has a “high bar” for bioequivalence studies and could remain durable as a sole generic “for a few years” before competitors catch up.
Using IQVIA sales data of about $112 million for 2025, Liawatidewi said rebates likely overstate the market size. He estimated the full generic market could be about $55 million after adjustments, with Amphastar potentially capturing more than 50% and possibly as much as 80% as the sole generic. That could represent roughly $40 million in annual sales, assuming no authorized generic enters the market.
BAQSIMI Pricing Pressure and 340B Issue
Executives also discussed BAQSIMI, the nasal glucagon product Amphastar acquired from Eli Lilly. Peters said the company lowered BAQSIMI guidance to flat to up single digits for the year after a weaker first quarter, but still expects companywide revenue growth to remain in the mid- to high-single-digit range.
Liawatidewi said BAQSIMI was affected by 340B “double discounting,” in which contract pharmacies serving 340B hospitals buy product at a discounted 340B price and then submit rebates tied to commercial insurance or pharmacy benefit managers. Peters said that issue contributed to about a 20% pricing decrease in the first quarter compared with the prior year.
Amphastar engaged a third-party service provider in May to mitigate the issue. Peters said the vendor has experience with larger pharmaceutical companies and believes it can eliminate about 80% of the double discounting. He said the impact should begin to appear partially in the second quarter and more fully by the third quarter. Amphastar also took a 3% price increase beginning in May to help offset the pricing pressure.
The company is also reassessing BAQSIMI sales outside the United States. Peters said Amphastar was contractually obligated to continue selling BAQSIMI in every country where Lilly had sold it for three years, a period ending in late June. After July 1, Amphastar plans to discontinue sales in five or six countries where the product loses money due to low prices or regulatory costs, though sales could continue temporarily in some markets due to inventory or notice-period requirements.
Biosimilar Insulin Aspart Targeted for 2027 Launch
Peters said Amphastar’s biosimilar insulin aspart product is under regulatory review, and the company continues to expect a launch in 2027. Amphastar is seeking interchangeability, which Peters described as a higher hurdle. He said the company believes it has provided sufficient data and responded to FDA concerns in a way that could support an interchangeable designation, though approval as a biosimilar without interchangeability remains possible.
Peters said IQVIA data place the insulin aspart market at about $1.4 billion in sales, while cautioning that IQVIA data tend to overstate actual sales. If approved, Amphastar expects to be the fourth player in the market, the third biosimilar and potentially the second interchangeable biosimilar. Asked whether annual sales of $25 million to $50 million were reasonable, Peters said the higher end could be achievable with interchangeability.
Pipeline and Business Development Focus
Liawatidewi said Amphastar’s synthetic corticotropin program remains in preclinical work intended to support an IND filing in 2027 or early 2027. He said Amphastar has not yet aligned with the FDA on whether the product would be viewed as comparable to existing porcine-based corticotropin or as a true new chemical entity. He added that Amphastar would most likely redo data generated in China by its licensing partner for U.S. submission.
Peters also discussed three in-licensed peptide-based assets from a Chinese biotech company, including two oncology products and one wet age-related macular degeneration product. The most advanced disclosed product is a potential pancreatic cancer therapy that uses a peptide conjugate to help direct molecules toward tumors. Peters said Amphastar’s experience with peptide APIs and finished products contributed to the company’s interest in those programs.
On capital allocation, Peters said Amphastar is focused on fully funding R&D, capital expenditures and its share repurchase program. The company added $50 million to the buyback program in March. Peters said future excess cash may be directed toward business development, particularly proprietary products closer to market or already de-risked through clinical trials, and that Amphastar could borrow for the right opportunity. He said the BAQSIMI transaction, which included $500 million up front plus deferred and milestone payments, would represent the “outer limit” of deal size the company could pursue.
Margins Expected to Improve From First Quarter
Peters said first-quarter gross margin represented an “absolute trough” and should improve in subsequent quarters as BAQSIMI pricing pressure eases. He said R&D spending is expected to remain high and could increase as a percentage of sales, while G&A should decline as a percentage of sales after a temporary uptick tied to efficiency projects and new systems. Selling expense is expected to remain relatively consistent as a percentage of sales, with potential for improvement over time through economies of scale.
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.
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The article "Amphastar Pharmaceuticals Sees Generic Atrovent Fueling 2026 Growth Despite BAQSIMI Drag" first appeared on MarketBeat.
