ANI Pharmaceuticals Q3 Revenue Rises 28% as It Offers $560 Million for Egetis

ANI Pharmaceuticals (NASDAQ: ANIP) reported a 28% increase in third-quarter 2026 revenue, supported by growth across its rare-disease and generics businesses, while announcing a cash offer valued at about $560 million to acquire Sweden-based Egetis Therapeutics. The proposed transaction would add EMCITATE, a newly launched treatment for peripheral thyrotoxicosis associated with MCT8 deficiency, to ANI’s rare-disease portfolio.

Total net revenue reached $290.8 million for the quarter ended September 30, up from $227.8 million a year earlier. Adjusted non-GAAP EBITDA increased 40% to $83.3 million, and adjusted non-GAAP diluted earnings per share rose 32% to $2.70.

ANI’s non-GAAP gross margin expanded by 260 basis points to 61.8%, even as non-GAAP cost of sales increased 20% to $111.0 million. Non-GAAP operating expenses rose 28% to $96.5 million.

The company generated $83.8 million of operating cash flow during the quarter and had $420.8 million of unrestricted cash and cash equivalents at quarter-end.

Cortrophin Gel leads rare-disease growth

Cortrophin Gel remained ANI’s largest growth driver, producing third-quarter net revenue of $138.7 million, up 36% year over year and 18% sequentially. The company reported demand across neurology, nephrology, rheumatology, ophthalmology and pulmonology, while its expansion into acute gouty arthritis flares contributed more revenue during the quarter.

In gout, ANI said its new prescriber base grew 67% from the second quarter and new patient cases doubled. Forty percent of prescribers initiated at least two cases, with demand balanced between podiatrists and primary-care physicians. The company is expanding its specialty-pharmacy network and patient-support capabilities to help convert demand into patients receiving therapy.

ILUVIEN generated $22.3 million of net revenue, an increase of 34% from a year earlier. ANI is focusing on expanding the product’s use among retina specialists for chronic non-infectious uveitis affecting the posterior segment of the eye. Results from the open-label SYNCHRONICITY study showed that 79.6% of study eyes had no recurrence of non-infectious inflammation over 24 months. The presentation noted that intraocular-pressure and cataract monitoring remain important considerations.

Generics and other revenue rose 10% to $108.4 million. ANI separately reported $104.5 million of generics revenue, up 11%, and said it had launched 16 generic products through the first nine months of 2026. The company plans to continue investing a high-single-digit percentage of generics revenue in research and development.

Brand royalties and other revenue totaled $11.5 million, while revenue from other branded products declined 7% to $10.0 million.

Egetis offer would add EMCITATE

ANI offered SEK 11.25 per share in cash for Egetis, valuing the offer at SEK 5.6 billion, or approximately $560 million. ANI estimated a net enterprise value of about $434 million after expected net proceeds from Egetis’ priority review voucher monetization.

The company plans to fund the acquisition with cash on hand and as much as $300 million of debt backed by a committed bridge-financing facility from JPMorgan Chase Bank. ANI expects trailing 12-month pro forma net leverage of approximately 2.7 times at closing.

EMCITATE became commercially available in the U.S. in October after receiving Food and Drug Administration approval on September 28, 2026. The treatment was approved by the European Commission in February 2025. It is indicated for peripheral thyrotoxicosis in adults and pediatric patients with MCT8 deficiency, an ultra-rare, X-linked disorder that primarily affects males.

ANI estimates that more than 1,000 people in the U.S. have MCT8 deficiency. Egetis has validated more than 100 patients and has about 60 patients participating in a U.S. expanded-access program concentrated at 17 sites. More than 300 patients globally are already receiving EMCITATE through managed- or expanded-access programs.

Management estimates that EMCITATE could generate more than $300 million in peak sales in its approved indication. ANI expects the transaction to dilute adjusted non-GAAP earnings per share in the first year because of investment in the U.S. commercial launch. The company also sees a potential pipeline opportunity for the drug in resistance to thyroid hormone beta.

Closing is expected in late 2026 or early 2027. The offer requires acceptance by holders of at least 90% of Egetis’ outstanding shares, as well as necessary regulatory approvals and other customary conditions.

2026 outlook

ANI now expects 2026 total net revenue of $1.085 billion to $1.125 billion, representing growth of 23% to 27%. Its previous range was $1.08 billion to $1.14 billion.

The company projects Cortrophin Gel revenue of $480 million to $500 million, compared with its prior range of $520 million to $540 million. ILUVIEN revenue is expected to be $80 million to $85 million, versus the previous $78 million to $83 million range.

Adjusted non-GAAP EBITDA is forecast at $290 million to $300 million, compared with the prior range of $285 million to $300 million. Adjusted non-GAAP diluted EPS is expected to be $9.37 to $9.71, versus the earlier $9.19 to $9.69 range. ANI expects a full-year adjusted non-GAAP gross margin of 60.3% to 61.0%.

Based on the midpoint of its guidance, ANI expects rare-disease revenue to account for more than half of total 2026 revenue. The company has also repurchased $20 million of shares year to date under its board-authorized $100 million repurchase program.

The Egetis acquisition remains subject to closing and regulatory conditions. ANI also identified commercialization, reimbursement, manufacturing, supply-chain reliability, competition and the integration of acquisitions as material uncertainties. The company relies on single-source third-party manufacturing for certain key products, including Cortrophin Gel and ILUVIEN, creating potential exposure to production delays or supply disruptions.