Will ANIP's Rare Disease Franchise Maintain Momentum in 2026?

Core Insights - ANI Pharmaceuticals' rare disease franchise, particularly the ACTH-based injection Cortrophin Gel, has driven significant growth in 2025, with sales increasing by 70% year over year to $236 million in the first nine months [1][8] - The company anticipates that its rare disease business will account for half of its total net revenues in 2025, with Cortrophin Gel sales projected to reach between $347 million and $352 million, reflecting a year-over-year growth of 75-78% [3][8] Sales Performance - Cortrophin Gel's sales growth is supported by an expanded sales force in neurology, rheumatology, and nephrology, as well as synergies from the integrated ophthalmology sales team [1] - The third quarter saw continued growth in prescriptions for the prefilled syringe, which constituted approximately 70% of newly initiated cases, with acute gouty arthritis flares being a significant contributor, accounting for over 15% of overall Cortrophin Gel utilization [2] Competitive Landscape - ANI's ophthalmology products, Iluvien and Yutiq, face competition from major pharmaceutical companies such as AbbVie and Regeneron, with AbbVie's Ozurdex and Regeneron's Eylea being direct competitors [5][6] - The primary competitor to Cortrophin Gel is Acthar Gel, marketed by Keenova Therapeutics, which has also raised its sales outlook for 2025, now expecting growth of 30-35% [6] Financial Performance - ANI Pharmaceuticals' shares have increased by 42.3% over the past year, outperforming the industry growth of 17.6% [7] - The company is currently trading at a premium valuation, with a price/sales (P/S) ratio of 2.04, compared to the industry average of 1.92 [9] Earnings Estimates - EPS estimates for 2025 and 2026 have seen upward revisions over the last 60 days, indicating positive market sentiment [11]