Amphastar Pharmaceuticals (NASDAQ:AMPH) executives on the company’s fourth-quarter earnings call highlighted new FDA approvals, continued growth for BAQSIMI, and expectations for mid-to-high single-digit revenue growth in 2026, while acknowledging ongoing competitive and pricing pressures in several legacy products.
2025 results: BAQSIMI growth offset by legacy headwinds
For full-year 2025, Amphastar reported net revenues of $719.9 million, a 2% decline that management attributed to “greater than expected headwinds” in legacy products. CFO Bill Peters said operating cash flow totaled $156.1 million.
Newer products also began contributing, including $4.4 million in revenue from iron sucrose following its August launch, along with “strong growth” in albuterol driven by market demand. These gains were partially offset by competitive pressures in epinephrine and glucagon, management said.
Fourth quarter: revenue down 2% as glucagon declines
Fourth-quarter 2025 sales decreased 2% to $183.1 million. BAQSIMI sales rose 12% to $46.7 million, while Primatene MIST sales declined 3% to $27.9 million.
Several established products saw sizable declines. Peters said glucagon sales fell 45% to $14.1 million, citing increased competition and a market shift toward ready-to-use products such as BAQSIMI. Epinephrine sales declined 9% to $17.1 million due to increased competition for the company’s epinephrine multi-dose vial products, partially offset by higher unit volumes for epinephrine pre-filled syringes amid supplier shortages during the quarter.
Other pharmaceutical product revenue increased 8% to $62.4 million, driven primarily by increased sales of albuterol and iron sucrose.
Gross margin was flat at 47% of revenues. Peters said increased sales of BAQSIMI and iron sucrose were offset by pricing declines in glucagon and epinephrine multi-dose vial products.
On expenses, selling, distribution, and marketing were essentially unchanged at $10.3 million. General and administrative expenses rose 27% to $16.5 million, primarily due to higher legal expenses and costs related to implementing a new ERP system. Research and development expenses increased 29% to $23.3 million, which Peters attributed to increased spending on the company’s insulin and proprietary pipeline programs.
Amphastar reported fourth-quarter net income of $24.4 million, or $0.51 per share, compared with $38.0 million, or $0.74 per share, a year earlier. Adjusted net income was $34.2 million, or $0.73 per share, versus $47.2 million, or $0.92 per share, in the prior-year quarter. Operating cash flow in the quarter was approximately $32.9 million.
Regulatory milestones and launch plans: ipratropium approval with exclusivity
Senior Vice President of Corporate Communications Dan Dischner described 2025 as “a pivotal year,” pointing to FDA approvals for iron sucrose and teriparatide. He also highlighted a new approval announced “just this week” for Ipratropium Bromide HFA Inhalation Aerosol (previously referenced as AMP-007). Amphastar said the FDA confirmed the product is eligible for 180 days of generic drug exclusivity as the first ANDA applicant with Paragraph IV certification.
The company expects to launch ipratropium commercially early in the second quarter of 2026, positioning it as a near-term growth driver and a meaningful addition to its respiratory portfolio.
In response to an analyst question, Peters said the Atrovent market data for last year was $112 million and that Amphastar expects a “meaningful” opportunity as the first entrant with 180 days of exclusivity. He added the company does not currently have visibility into whether an authorized generic will be launched. Management characterized the prior decline in the market as driven “mostly” by pricing rather than demand, and said it appears “fairly stable” at this point.
2026 outlook: mid-to-high single-digit revenue growth, margin pressure expected
Looking ahead, Amphastar said its 2026 assumptions include:
- BAQSIMI: Mid-single-digit unit growth in the U.S., partially offset by a planned reduction in international volume as the company exits “a handful of unprofitable markets” later in the year. Peters said Amphastar does not expect to take price increases in 2026, focusing instead on unit growth. He noted the company had a three-year commitment to market BAQSIMI in all countries where Lilly previously sold the product, which expires in July.
- Primatene MIST: Mid- to high-single-digit unit growth and a planned 5% price increase in the second quarter.
- Ipratropium Bromide HFA: Management called the product the “largest driver of growth,” with a planned early second-quarter launch and ramp expected through the year.
- Other factors: Increased contributions from third-party API sales from the ANP subsidiary, offset by expected sales declines from competition in glucagon and, to a lesser extent, epinephrine and phytonadione.
Overall, Amphastar expects consolidated revenue growth in the mid-to-high single-digit range in 2026. Peters also said gross margins are expected to be lower, primarily due to continued pricing pressure in high-margin legacy products (including glucagon, epinephrine, and phytonadione), higher input costs (including labor and supplier increases), and a higher mix of lower-margin API sales from the company’s China business. He added that exiting negative-margin BAQSIMI markets in the second half should be a margin tailwind, but said the expected decline in glucagon is “fairly large.”
Pipeline, manufacturing expansion, and capital allocation
Management said it expanded its proprietary pipeline with programs identified as AMP-105, AMP-109, AMP-110, and AMP-107, which executives said collectively represent more than $60 billion in addressable market opportunity. The company also reiterated that its insulin aspart BLA for AMP-004 and GLP-1 ANDA for AMP-018 are moving through regulatory proceedings, with anticipated commercialization for each expected in 2027.
On AMP-110, the corticotropin program, management said it has not yet engaged the FDA and is still developing the program internally. Regarding business development priorities, Amphastar said its focus will be on areas where it has an existing or planned presence, including endocrinology, oncology, ophthalmology, and immunology.
Amphastar also discussed its manufacturing expansion in Rancho Cucamonga, which Dischner said will quadruple production capacity at the site. Peters said the project’s capital spending will ramp more significantly in 2026 and that the company plans to finance the expansion with operating cash flow.
As of the call, Peters said Amphastar had over $300 million in cash and short-term investments and intends to continue its stock buyback program. He noted the company repurchased about $75 million of stock last year and had about $15 million remaining under the current authorization, with the possibility of another authorization later in 2026 depending on business development opportunities.
On Primatene MIST competition, management said the patent has already expired, it does not currently see competition, and believes competition is unlikely given the economics and the product’s brand equity. Executives also said the company is developing a new formulation of Primatene MIST, has secured one patent, and is working on another.
In closing remarks, management said it believes momentum from recent approvals and pipeline progress positions Amphastar for continued growth, while reiterating its focus on disciplined execution and investment through 2026.
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.
