Amphastar Pharmaceuticals (NASDAQ:AMPH) reported record third-quarter revenue of $207.6 million, up 8% from a year earlier, as sales of BAQSIMI and Primatene MIST and contributions from newer products offset manufacturing disruptions and lower pricing on some established medicines.
The company expects fourth-quarter sales to rise in the high single digits from a year earlier, Chief Financial Officer Bill Peters said on the earnings call. That outlook includes a modest slowdown in sales from its IMS manufacturing facility as Amphastar carries out corrective actions following an FDA warning letter.
Commercial Products Drive Growth
BAQSIMI net sales rose 10% to a record $58.8 million, driven by higher unit volume. Peters said increased units contributed $7.4 million in sales, partially offset by a roughly $2.2 million impact from lower average selling prices, largely associated with higher rebates and 340B pharmacy discounts.
Amphastar has been working to identify and resolve potential duplicate 340B discounts. Peters said the company was getting closer to its 80% target for addressing the issue, although he did not expect it to exceed that level. He said the pricing impact was significantly smaller than in the previous two quarters.
Tony Marrs, executive vice president of regulatory affairs and clinical operations, said Amphastar does not expect BAQSIMI pricing to return to previous levels because of duplicate discounts. A 3% price increase taken this year did not fully offset the pressure, he said.
Primatene MIST sales rose 9% to a record $31.5 million, supported by a second-quarter price increase and higher unit volumes. Dan Dischner, senior vice president of corporate communications, said in-store unit sales rose approximately 2.5% from a year earlier.
Among other products, ipratropium bromide generated $6.6 million in sales after its April launch, while teriparatide contributed $6.4 million. Lidocaine sales increased 29% to $16.6 million, helped by a shortage at another supplier. Epinephrine sales fell 19% to $15.3 million, primarily because of slower releases at IMS, and glucagon sales declined 37% to $8.6 million amid increased competition.
IMS Remediation Weighs on Margins
Gross margin declined to 48% from 51% a year earlier. Peters said lower pricing for BAQSIMI, glucagon and epinephrine multi-dose vials was the primary factor, alongside increased manufacturing costs related to the IMS remediation. Higher-margin sales of newer products partly offset those pressures.
Remediation added approximately $2 million to $3 million in expenses during the quarter, Peters said. He expects that amount to be somewhat higher in each of the next two or three quarters.
Marrs said Amphastar is providing routine progress updates to the FDA and working with a third-party partner. Peters said the company had added quality controls and was bringing in additional resources, with the expectation that production could return relatively soon to its earlier level.
The company’s IMS facility had a $12.5 million backlog, Peters said, adding that Amphastar aims to reduce it in the fourth quarter. He said demand for lidocaine was expected to continue into next year, although competing demands on facility resources affect how much the company can deliver.
Pipeline and Outlook
Amphastar remains on track for a potential 2027 launch of its insulin aspart biosimilar and interchangeable program, subject to FDA approval, Dischner said. Peters said the launch was not imminent and that the company did not yet have a firm date.
Dischner said the company expects a limited opportunity for AMP-018 because of competition but remains on track for 2027 commercialization. He also noted that the insulin aspart market already has several competing products, although Amphastar sees room in the market.
For AMP-101, an intranasal epinephrine candidate, Amphastar refined its study design and formulation following regulatory feedback. Other early-stage programs include AMP-109 for oncology, AMP-110, a synthetic human corticotropin program, and AMP-107, an ophthalmic program targeting wet age-related macular degeneration and diabetic macular edema.
Peters said Amphastar aims to file AMP-104, a lower-global-warming-potential formulation of Primatene MIST, by the end of 2028. The company has one approved patent and has filed another, he said.
Amphastar generated approximately $43.3 million in operating cash flow during the quarter. Its board also authorized an additional $50 million for the company’s share repurchase program. Peters declined to provide 2027 guidance but said the company expects growth from BAQSIMI and Primatene MIST, as well as a full year of ipratropium sales.
About Amphastar Pharmaceuticals (NASDAQ:AMPH)
Amphastar Pharmaceuticals, Inc is a biopharmaceutical company that develops, manufactures and markets injectable, inhalation and intranasal products. The company focuses on technically challenging medicines, including complex generics, proprietary products and products based on its drug-delivery technologies.
Its product portfolio includes Primatene MIST, an over-the-counter epinephrine inhaler; Baqsimi, a nasal glucagon product used to treat severe hypoglycemia; and injectable medicines such as glucagon, naloxone, enoxaparin and hyaluronidase.
