Amphastar Pharmaceuticals Q1 Earnings Call Highlights

Key Points

• Q1 revenue was roughly flat at about $171.2 million, but profitability fell sharply—net income dropped to $6.4 million (from $25.3 million) and adjusted net income fell to $19.5 million—while the company repurchased $29.5 million of shares.
• BAQSIMI revenue fell ~15% to $32.4 million due to lower average selling prices driven by higher rebates and 340B discounts despite an ~8% rise in units; Amphastar is auditing potential duplicate 340B rebates, raised BAQSIMI list prices 3% effective May 1, and will gradually exit a few international markets.
• New-product momentum is driving outlook: AMP-007 (ipratropium inhalation) launched in April as the first generic on the market and is expected to be the biggest growth driver this year, while insulin-aspart and GLP‑1 biosimilar programs remain on track for 2027 commercialization.

Amphastar Pharmaceuticals NASDAQ: AMPH reported first-quarter 2026 net revenues of approximately $171.2 million, up slightly from $170.5 million in the prior-year period, as recently launched products helped offset pricing pressure and increased competition across parts of its legacy portfolio.

On the company’s earnings call, Senior Vice President of Corporate Communications Dan Dischner said the quarter reflected “continued strength and balance” in Amphastar’s underlying business despite a “rapidly evolving market landscape.” Dischner added that Amphastar is “actively managing near-term pricing and competitive pressures across certain legacy products” while continuing to invest in its branded portfolio, biosimilars, complex generics, and manufacturing infrastructure.

Branded products: BAQSIMI pricing pressure; Primatene MIST steady

BAQSIMI generated about $32 million in quarterly revenue, which Dischner said was impacted by “higher rebates, channel mix, and increased utilization of government programs,” dynamics he characterized as industry-wide. He noted that underlying demand remained positive, with U.S. unit volumes increasing approximately 8% year-over-year.

CFO Bill Peters provided additional detail, stating BAQSIMI revenue decreased 15% to $32.4 million from $38.4 million a year ago due to lower average selling prices, partially offset by the 8% increase in units sold. Peters attributed the lower average selling price to “higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated.”

During the Q&A, management said seasonality did not drive BAQSIMI’s pricing issues. Peters said the company believes “some duplicate rebates” may be tied to 340B pharmacy activity and that Amphastar engaged an outside firm to validate claims before they are paid, with the process beginning in early May. He also said the company implemented a 3% list price increase for BAQSIMI effective May 1.

“We believe that we could get at least partway back to the pricing where we were last year, or most of the way back by later this year,” Peters said.

Management also discussed plans to discontinue BAQSIMI commercialization in a handful of international markets, noting the process will be gradual due to country-specific notice periods and existing inventory. Peters said the discontinuation would begin in July, but in some markets sales could continue “through the end of this year and into the first quarter of next year.” He emphasized that Amphastar expects to remain in most international markets, including top-selling ones, and does not anticipate a significant revenue drop from the change.

Primatene MIST posted revenue of approximately $30 million in the quarter. Dischner said performance was supported by sustained consumer demand and marketing, with store-level sales rising about 6.5% year-over-year. Peters reported Primatene MIST sales of $29.8 million, up 2% from $29.1 million in the prior-year quarter.

Asked about potential generic competition for Primatene MIST, management said it has not been notified of a generic entrant and has “no visibility” into whether one is in development. The company reiterated its view that it would be difficult to genericize the product, citing regulatory and over-the-counter retail dynamics. Management also referenced ongoing development of a “green version” and said Amphastar has one patent issued and another pending.

New product momentum and legacy product pressure

Dischner highlighted FDA approval and an April launch for AMP-007, Amphastar’s ipratropium bromide inhalation product. He said the product is currently “the first and only generic ipratropium inhalation product on the market,” which the company believes creates a meaningful near-term opportunity.

In response to an analyst question, management declined to provide a sales forecast for AMP-007 but said it expects the launch to be its “biggest growth driver this year.” Management noted that, as of the call, the product had been on the market for nearly a month without a generic competitor, and said this supported Amphastar’s ability to maintain its broader sales growth outlook for 2026.

Peters detailed performance across other products:

• Epinephrine sales rose 3% to $19.2 million, with increased demand for the prefilled syringe partially offset by increased competition in multidose vials.
• Glucagon injection sales fell 56% to $9.2 million due to increased competition and a shift toward ready-to-use products.
• Other finished pharmaceutical product sales increased 34% to $67.1 million, driven primarily by recently launched products.

Peters said the increase in “other finished pharmaceutical product sales” included higher albuterol sales of $2.8 million, iron sucrose sales of $1.4 million, and teriparatide sales of $2.2 million, with those products launched in August 2024, August 2025, and December 2025, respectively. He added that dextrose sales rose due to shortages from other suppliers, while phytonadione sales declined due to increased competition.

On glucagon, management said it does not believe the product has reached a bottom. Peters said the decline should continue but at a slower rate than in prior periods.

Margins, earnings, and capital allocation

Amphastar reported cost of revenues of $100.8 million, up from $85.3 million. Peters said gross margins declined to 71% of revenues in the first quarter of 2026 from 50% in the prior-year period, citing lower BAQSIMI net pricing, lower sales of certain higher-margin products (glucagon, phytonadione, and epinephrine multidose vials), and increased costs at the company’s Amphastar facility.

Selling, distribution, and marketing expense was $11.9 million, roughly unchanged year-over-year. General and administrative expenses increased 13% to $18.0 million, driven by higher legal costs, salary and personnel expenses, and costs associated with implementing a new ERP system.

Research and development expense increased 33% to $26.7 million. Peters said the increase included a $2 million upfront payment related to in-licensing a new corticotropin product, as well as spending on Amphastar’s insulin, inhalation, and proprietary pipeline programs.

Net income declined to $6.4 million, or $0.14 per share, compared to $25.3 million, or $0.51 per share, a year ago. Adjusted net income was $19.5 million, or $0.42 per share, down from adjusted net income of $36.9 million, or $0.74 per share, in the first quarter of 2025. Peters said adjusted results exclude amortization, equity compensation, and one-time events.

Amphastar generated approximately $47.8 million in operating cash flow during the quarter. Peters said the company accelerated its share repurchase program and bought back $29.5 million worth of shares, representing about 3% of its share count.

Guidance updates and pipeline timeline

Peters said the company updated its 2026 outlook for BAQSIMI, now expecting revenue growth to be “flat to up low single-digit percentages” versus last year due to pricing pressures. He said Amphastar is maintaining overall corporate sales guidance of “mid-single digit to high single-digit unit growth,” citing strength across the broader portfolio, including the newly launched ipratropium bromide inhalation product, which “currently does not face any generic competitors.”

On the pipeline, Dischner said Amphastar remains on track with its insulin aspart biosimilar and its GLP-1 ANDA program, both planned for commercial launches in 2027. Asked about AMP-004 (insulin aspart), management said the program remains in progress and “nothing’s changed,” reiterating the 2027 commercialization plan. Management also discussed a synthetic corticotropin program (referred to as AMP-110 in the Q&A), with Executive Vice President of Regulatory Affairs and Clinical Operations Tony Marrs stating the company has not yet met with the FDA for that program and does not have alignment on an expedited approval pathway, though it believes expedited approvals may be possible for certain pipeline products.

Looking ahead, Dischner said Amphastar expects continued contributions over the next 12 to 18 months from BAQSIMI, Primatene MIST, and the ipratropium bromide launch, while working toward upcoming regulatory and development milestones across its biosimilar and proprietary programs.

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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.