Amphastar Pharmaceuticals NASDAQ: AMPH reported second-quarter 2026 revenue growth, supported by recently launched products including ipratropium bromide inhalation, while management said it is addressing an FDA warning letter at its IMS subsidiary and continuing investments in its pipeline and U.S. manufacturing operations.
Revenue rose 5% year over year to $183.9 million for the quarter ended June 30, from $174.4 million. Net income was $30.3 million, compared with $31 million a year earlier, while diluted earnings per share increased to $0.67 from $0.64. Adjusted net income was essentially unchanged at $40.8 million, though adjusted EPS rose to $0.91 from $0.85.
“The second quarter was marked by strong execution across each of our strategic growth pillars,” Senior Vice President of Corporate Communications Dan Dischner said. He cited commercial demand, manufacturing expansion, and progress in development and regulatory programs.
New launches support sales and margins
Ipratropium bromide inhalation, launched in April, generated $8.4 million in second-quarter sales and was the largest contributor to revenue growth, Chief Financial Officer Bill Peters said. Management said the product, a generic version of Atrovent, has gained a “nice market share” and is approaching the company’s previously stated goal of capturing 50% to 80% of the market.
Other products generated $66.2 million in sales, up 25% from $53.1 million a year earlier. The increase reflected recently launched iron sucrose, which contributed $3.5 million, and teriparatide, which added $4.5 million. Increased sales of albuterol, phytonadione, sodium bicarbonate, and active pharmaceutical ingredients from the company’s AMP subsidiary also contributed.
Gross margin increased to 51% of revenue from 50% a year earlier. Peters attributed the improvement primarily to higher-margin launches, including ipratropium bromide, teriparatide, and iron sucrose. The benefit was partly offset by lower average selling prices for BAQSIMI, glucagon, and epinephrine multidose vials, as well as increased manufacturing costs at an Amphastar facility.
Management expects third-quarter gross margin to be similar to the second quarter. Peters said anticipated higher BAQSIMI sales should help offset added expenses related to IMS remediation efforts.
BAQSIMI prescriptions rise, while pricing weighs on sales
BAQSIMI net sales declined 3% to $45.5 million from $46.7 million in the prior-year quarter, despite a 17% increase in total prescriptions. Peters said higher unit sales added $6.9 million in revenue, but lower average selling prices reduced sales by about $8.1 million, largely because of increased rebates and 340B pharmacy discounts that may have included duplicate discounts.
The company hired a third party in May to identify, validate, and resolve potential duplicate 340B discounts. Management said it had achieved roughly half of its previously discussed goal of reducing 80% of the double-discounting issue.
In June, Amphastar completed the third contract year following its BAQSIMI acquisition from Eli Lilly. The product generated $178.3 million in net sales during that contract year, exceeding the $175 million threshold required to trigger the first milestone payment. Amphastar said the milestone creates a $100 million payment obligation due in the third quarter of 2026.
Primatene MIST sales declined 8% to $21 million, from $22.9 million a year earlier, due to the timing of customer purchases. Dischner said in-store sales increased both sequentially and year over year, and attributed the reported sales decline to ordering patterns and shipment timing connected with discussions with certain retailers.
Glucagon sales fell 42% to $11.9 million as competition increased. Management said the pace of decline should moderate but does not expect glucagon to return to growth, citing continued pressure in the anti-hypoglycemia portion of the market.
IMS warning letter adds costs and may slow sales
IMS received an FDA warning letter related to an inspection conducted in December 2025. The company said it responded to the agency in late July, has retained an independent consultant, and will provide the FDA with regular updates on its remediation plan.
Management said the warning letter does not require IMS to halt manufacturing or product distribution. IMS accounts for roughly one-third of Amphastar’s overall sales, Peters said, and the facility continues to ship and produce products. However, additional quality reviews have slowed some batch releases.
Executive Vice President of Regulatory Affairs and Clinical Operations Tony Marrs said potential production shutdowns could occur if warranted by remediation findings, but management does not currently expect such shutdowns.
Amphastar expects IMS remediation expenses to rise by $2 million to $3 million per quarter for the next several quarters. Capital spending at IMS will also increase, although the company said its overall capital-expenditure outlook is unchanged because it will redirect spending from its Amphastar facility. The company also anticipates a slight slowdown in IMS sales as it focuses on corrective actions.
Despite those factors, management maintained its outlook for mid-single-digit to high-single-digit corporate sales growth in 2026.
Pipeline advances toward 2027 insulin launch
Research and development expense rose 10% to $22.2 million, primarily due to higher clinical trial spending for Amphastar’s insulin program. The company said its insulin aspart biosimilar and interchangeable program remains on track for potential commercialization in 2027, subject to regulatory approval. Management expects the product’s gross margin to be at or slightly below corporate gross-margin levels given expected competition.
The company also initiated a Phase 1 clinical program for AMP-101, an epinephrine nasal product. Nonclinical studies are underway for AMP-109, a targeted oncology program, following what management described as constructive FDA feedback. Amphastar is preparing for further regulatory interactions and an anticipated investigational new drug application submission.
Development also continues for AMP-110, a synthetic human corticotropin program, and AMP-107, an eye-drop program for wet age-related macular degeneration and diabetic macular edema. Management said both programs are being advanced toward future IND submissions.
During the quarter, Amphastar generated about $51.3 million in operating cash flow and accelerated its share repurchase activity, buying back approximately $45 million of shares.
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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