ANI Pharmaceuticals Sees Rare Disease Focus Drive Revenue to $1.1B+ in 2026

ANI Pharmaceuticals reported record second-quarter 2026 results, with total revenue of $266 million and adjusted non-GAAP EBITDA of $71.6 million, marking its highest figures to date. The company’s strategic push into rare diseases is accelerating, with Cortrophin Gel—the repository corticotropin product—accounting for 43% of Q2 sales, up from $75 million in Q1 2026 and a 43% year-over-year increase. The product’s intellectual property exclusivity extends through 2043, and its market potential is vast: the company estimates a total addressable patient base of nearly 1 million across six to seven priority indications, with nearly half of current prescribers newly adopting the drug in the ACTH (adrenocorticotropic hormone) category. Cortrophin’s sales surged from $42 million in 2022 to $347 million in 2025, while the broader ACTH market is projected to exceed $1.3 billion in 2026, up more than 30% year-over-year. The company also guided full-year 2026 revenue between $1.08 billion and $1.14 billion, with Cortrophin sales expected to reach $520 million to $540 million—a slight downward revision from earlier projections of $540 million to $575 million—and ILUVIEN (an intravitreal implant for diabetic macular edema and chronic non-infectious uveitis) at $78 million to $84 million. Adjusted non-GAAP EBITDA guidance ranges from $285 million to $300 million, reflecting robust profitability. ANI’s rare disease focus is expected to constitute 60% of total sales by year-end 2026, underscoring its strategic pivot. The company’s generics business, bolstered by the Novitium Pharma acquisition, remains a stable contributor, with revenue growth of 28% in 2025 and modest expectations for 2026 before resuming high single-digit to low double-digit growth. ANI’s expansion into gout management has also gained momentum, with sales force growth of 60%—scaling from 120 to 180 representatives—and a targeted focus on 285,000 of the estimated 10 million gout patients, including 7,000 high-volume prescribers. The company’s balance sheet remains strong, with $360 million in cash on hand and a net leverage ratio of 1.0x, well within its historical tolerance of 4.0x. Free cash flow for the first half of 2026 was $100 million, compared with $150 million for the full year of 2025. The company’s market capitalization stands at $1.51 billion, with a trailing 12-month P/E ratio of 15.54. Nikhil Lalwani, president and CEO, emphasized the company’s transformation into a leader in rare diseases, citing strong demand indicators for Cortrophin and ILUVIEN. He noted that the growth trajectory of these assets, along with the $100 million share repurchase program approved in May 2026, reflects confidence in the company’s long-term potential. ANI’s expansion into rare diseases and generics is underpinned by a robust manufacturing footprint, with 95% of sales from U.S.-based facilities in Minnesota and New Jersey, supporting its commitment to scaling production capacity for new products, including 10 to 15 launches annually.