Adjusted non-GAAP EBITDA was $54.1 million, a 63% increase from the prior year period, and adjusted non-GAAP EPS was $1.80, up from $1.02.
ANI Pharmaceuticals reported record Q2 2025 results with net revenues of $211.4 million, up 53% year-over-year on an as-reported basis and 37% organically.
Cash flow from operations was $110.8 million in the first half of 2025, with unrestricted cash increasing to $217.8 million at quarter-end.
Generics revenues increased 22% to $90.3 million, supported by new product launches including prucalopride tablets with 180-day exclusivity.
Non-GAAP gross margin improved to 64.9%, up over 6 points from the prior year, due to favorable product mix and strong generics performance.
Operating expenses increased, with R&D up 130% to $16 million and SG&A up 66% to $67.1 million, reflecting investments in sales teams and clinical studies.
Rare Disease revenues doubled year-over-year to $104 million, driven by Cortrophin Gel revenues of $81.6 million, up 66% year-over-year.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
Capital expenditures totaled $94 million, and depreciation and amortization were $119 million.
EBIT margin increased 50 basis points to 22.8% due to gross margin improvement and operating expense leverage.
Free cash flow was strong at $327 million, supported by earnings growth and working capital improvements.
Gross margin improved by 20 basis points to 45.3%, with positive price and productivity gains offsetting inflation and tariff costs.
Net income from continuing operations was $231.2 million, with adjusted EPS of $2.34, a 15% increase year-over-year.
The company announced its 20th consecutive year of dividend increases, raising the quarterly dividend by 10% to $0.63.
Total debt was reduced to $1.9 billion, with a gross debt to EBITDA ratio of 1.2x.
Total reported revenue grew 9% in Q1 2026, with constant currency organic revenue growth of 8%, driven by volume and 230 basis points of price increases.