ANI Pharmaceuticals, Inc.

ANI reported second-quarter 2026 total net revenues of $266 million, up 26% year over year. Cortrophin Gel revenue was $117.1 million, up 43% year over year; ILUVIEN revenue was $18.7 million, down 16% year over year due primarily to international shipment timing; Harmony-related revenue was $17.7 million; and Generics revenue was $99.1 million, up 10% year over year. Non-GAAP gross margin was 62.6%, down about 230 basis points year over year, adjusted non-GAAP diluted EPS was $2.21 versus $1.80 last year, and adjusted EBITDA was $71.6 million, up 32% year over year. For 2026, ANI guided to total net revenue of $1.08 billion to $1.14 billion, adjusted EBITDA of $285 million to $300 million, adjusted EPS of $9.19 to $9.69, and adjusted gross margin of 59.9% to 60.9%. Cortrophin guidance was revised to $520 million to $540 million, ILUVIEN guidance was reaffirmed at $78 million to $83 million, and third-quarter Cortrophin was guided to $143 million to $153 million.

Nikhil Lalwani framed the quarter as evidence that ANI’s transformation into a rare disease company is advancing on plan, with record results, a larger commercial footprint, and growing confidence in Cortrophin’s durability. He emphasized that the gout expansion was launched on schedule, that July showed the highest number of new cases initiated in existing specialties, and that the company sees a large, underpenetrated patient opportunity across both gout and other indications. His tone was constructive and confident, but he repeatedly tied the outlook to execution on demand generation, patient access, and the phased impact of the newly expanded sales force.

Stephen Carey highlighted the core financials: $266 million in quarterly revenue, $99.6 million in non-GAAP cost of sales, 62.6% non-GAAP gross margin, $14.1 million of R&D, $80.7 million of SG&A, $71.6 million of adjusted EBITDA, and $2.21 of adjusted non-GAAP diluted EPS. He also pointed to $360.2 million of unrestricted cash at quarter-end, $56.7 million of operating cash flow in Q2, $115 million year to date, $620.9 million of outstanding debt, gross leverage of 2.4x, and net leverage of 1x trailing 12-month adjusted EBITDA of $259.6 million. On guidance, he reaffirmed company-wide targets and noted that Q3 EBITDA should be down sequentially because the final $2 million Harmony milestone lands in Q3 and Q3 is the first fully loaded quarter of the gout expansion, with Q4 expected to be the highest EBITDA quarter of the year.

Analysts focused on whether the new gout launch is already driving prescriptions, how much of the Cortrophin guide cut reflects access issues versus timing, and why Q4 is expected to step up so sharply. Management said the insurance reverification problem that hurt Q1 is behind them, that Q2 had no impact from reverifications, and that the Cortrophin guide revision mainly reflects first-half results while the back half remains intact. On gout, ANI said over 95% of the new reps have generated multiple new cases, over 1/3 of prescribers have initiated 2 or more cases, and July showed record new cases; management also said new cases are the same as enrollment forms/prescriptions and that fulfillment can take from a couple of days to weeks. When pressed on IQVIA, management said the data can be volatile and that internal metrics are more useful for tracking the launch.