ANI Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Raises 2025 Guidance

Core Insights - ANI Pharmaceuticals reported a strong first quarter for 2025, achieving record revenue, adjusted EBITDA, and adjusted EPS, primarily driven by high demand for Cortrophin Gel and strong performance in the Generics business [2][3]. Financial Performance - Total net revenues for the first quarter of 2025 reached $197.1 million, marking a 43.4% increase compared to the same period in 2024 [11][13]. - Adjusted non-GAAP EBITDA for the quarter was $50.7 million, reflecting a 34.9% year-over-year increase [19]. - The diluted GAAP income per share was $0.69, while the adjusted non-GAAP diluted earnings per share reached a record $1.70, up from $1.21 in the prior year [18][53]. Product Performance - Cortrophin Gel generated $52.9 million in revenue for the first quarter, a 43.1% increase year-over-year, with significant growth in new patient starts and prescriber base [4][14]. - Revenues from the retina assets ILUVIEN and YUTIQ totaled $16.1 million, impacted by Medicare access challenges and sales team turnover [6][14]. - Generics revenues surged by 40.5% year-over-year to $98.7 million, driven by new product launches and strong base business execution [9][14]. Guidance and Outlook - The company raised its 2025 guidance for total revenues to a range of $768 million to $793 million, with adjusted non-GAAP EBITDA expected between $195 million and $205 million [3][21]. - Cortrophin Gel is projected to contribute approximately 47% to 48% of total revenues in 2025, with expected revenues between $265 million and $274 million [11][21]. Strategic Developments - ANI received FDA approval for a prefilled syringe version of Cortrophin Gel, enhancing patient convenience [5]. - The company is addressing challenges in the retina franchise with a multi-pronged approach, which has shown positive results in the second quarter [6][4].