ANI Pharmaceuticals (NASDAQ:ANIP) reported 28% revenue growth for the third quarter of 2026 and announced an offer to acquire Egetis Therapeutics for $560 million in equity value, while lowering its full-year sales outlook for Cortrophin Gel after pharmacy bottlenecks slowed the conversion of new patient cases into treatment.
The company reported total net revenue of $290.8 million and adjusted EBITDA of $83.3 million, up 40% from a year earlier. Adjusted diluted earnings per share rose to $2.70 from $2.04.
President and Chief Executive Officer Nikhil Lalwani said Cortrophin revenue fell short of the company’s expectations despite strong demand, particularly following an expansion into the treatment of acute gouty arthritis flares. ANI now expects 2026 Cortrophin revenue of $480 million to $500 million, down from its previous forecast of $520 million to $540 million.
Cortrophin Demand Outpaces Pharmacy Capacity
Cortrophin generated $138.7 million in third-quarter revenue, up 36% year over year. Lalwani said new gout patient cases doubled from the second quarter, while the number of new prescribers in the gout expansion rose 67%.
That increase strained ANI’s specialty pharmacy network, slowing processing for gout cases as well as cases in existing specialties, including neurology, nephrology and rheumatology. Primary care and podiatry offices unfamiliar with ACTH therapy also took longer than expected to navigate the enrollment and fulfillment process, executives said.
Chris Mutz, senior vice president and head of ANI’s rare disease business, said the company has expanded its pharmacy network in high-demand regions, strengthened coordination with existing pharmacies and added patient-support resources. He said ANI saw modest improvement in the time to a first prescription fill in late in the third quarter and early in the fourth quarter.
Lalwani told analysts that ANI would have met its third-quarter Cortrophin expectations without the revenue-conversion delays. He said the revised full-year forecast does not assume the full benefit of the company’s corrective measures. ANI does not plan to scale back its primary care and podiatry expansion, he added.
Egetis Offer Adds Recently Launched Rare Disease Drug
ANI’s all-cash offer for Egetis would add EMCITATE, which is approved in the U.S. and European Union to treat peripheral thyrotoxicosis associated with MCT8 deficiency. The U.S. Food and Drug Administration approved the drug in September, and it became commercially available in the U.S. on Oct. 27, executives said.
Chief Medical Officer Mary Pao described MCT8 deficiency as a rare, life-shortening condition that causes a lack of thyroid hormone activity in the central nervous system and excess thyroid hormone activity in peripheral tissues. ANI estimates that more than 1,000 people in the U.S. live with the condition, while more than 100 have been genetically identified.
Approximately 60 U.S. patients receive EMCITATE through an expanded-access program. Mutz said the initial commercial priorities include securing payer coverage, transitioning those patients to reimbursed treatment and reaching diagnosed patients who are not yet receiving the drug.
Lalwani said EMCITATE has the potential to generate more than $300 million in annual peak sales in its approved indication. ANI did not provide a timeline for reaching that level or a 2027 revenue forecast. He said Egetis set a wholesale acquisition cost of $74,026 per pack of 60 tablets, equivalent to approximately $950,000 annually based on the average daily dose observed in a clinical trial. Dosing is adjusted for patient weight.
The proposed transaction has an enterprise value of approximately $434 million, net of $95 million in cash proceeds Egetis agreed to receive from the sale of a priority review voucher. ANI plans to use cash and up to $300 million in debt, supported by a committed JPMorgan bridge financing facility. The deal is expected to close in late 2026 or early 2027, subject to customary conditions.
Chief Financial Officer Stephen Carey said ANI expects the acquisition to dilute adjusted EBITDA and non-GAAP earnings per share in its first year as the company invests in the U.S. launch.
Generics Strength Supports Updated Outlook
Generics revenue rose 11% to $104.5 million in the quarter, aided by a partner product launch, new products and operational performance. ANI said it had launched 16 generics in the first nine months of the year. ILUVIEN revenue increased 34% to $22.3 million.
For 2026, ANI expects total net revenue of $1.085 billion to $1.125 billion, adjusted EBITDA of $290 million to $300 million and adjusted diluted earnings per share of $9.37 to $9.71. It raised its ILUVIEN revenue forecast to $80 million to $85 million.
ANI ended the third quarter with $420.8 million in unrestricted cash and $616.9 million in outstanding debt principal. Carey said the company had repurchased 275,000 shares for $20 million year to date under its $100 million repurchase authorization.
About ANI Pharmaceuticals (NASDAQ:ANIP)
ANI Pharmaceuticals, Inc is a specialty pharmaceutical company that develops, manufactures and markets branded and generic prescription medicines. The company focuses on products with limited competition, complex formulations and specialized manufacturing requirements, serving therapeutic areas that include endocrinology, immunology, ophthalmology, dermatology and central nervous system disorders.
ANI’s portfolio includes branded products and generic medicines, as well as treatments for rare diseases.
