Here's How ANIP's Rare Disease Portfolio Is Driving Top-line Growth

Core Insights - ANI Pharmaceuticals' rare disease franchise has become a significant growth driver in 2025, with segment revenues exceeding $291 million in the first nine months, more than doubling year over year [1][7] Revenue Growth - The growth is primarily driven by the ACTH-based injection Cortrophin Gel, which saw a 70% year-over-year sales increase to $236 million in the first nine months of 2025, supported by heightened demand across various specialties and an expanded sales force [2][7] - For the full year 2025, Cortrophin Gel sales are projected to reach between $347 million and $352 million, indicating a 75-78% increase from the previous year [2] Product Performance and Outlook - The performance of the rare disease franchise is helping to mitigate weaker contributions from newly acquired ophthalmology assets, Iluvien and Yutiq, with revised sales expectations for these products set at $73 million to $77 million due to reimbursement challenges [3] - Despite the current challenges, the company anticipates a return to growth for the ophthalmology franchise in 2026, driven by enhanced field efforts and a larger patient population [3] Competitive Landscape - ANI Pharmaceuticals faces competition in its rare disease portfolio, particularly for Iluvien and Yutiq, from major pharmaceutical companies like AbbVie and Regeneron, which market established products [4] - The primary competitor for Cortrophin Gel is Acthar Gel, marketed by Keenova Therapeutics, which has also raised its sales outlook for 2025 [5] Valuation and Market Performance - ANI Pharmaceuticals' shares have outperformed the industry year to date, and the company is currently trading at a discount compared to the industry, with a price/sales ratio of 2.00 versus the industry average of 2.41 [6][9] - EPS estimates for 2025 and 2026 have seen upward revisions over the past month [11]