ANI Pharmaceuticals(US:ANIP) Globenewswire·2025-11-07 11:50Core Insights - ANI Pharmaceuticals reported a strong third quarter with record revenue and adjusted EBITDA, highlighting the growth in its Rare Disease and Generics business units [2][7] - The company anticipates that net revenues from its Rare Disease business will account for approximately 50% of total revenues in 2025, driven by the success of Cortrophin Gel [2][7] - ANI has raised its financial guidance for 2025, expecting total net revenue growth of 39% to 42% year-over-year and adjusted EBITDA growth of 42% to 46% [2][7] Financial Performance - Total net revenues for Q3 2025 reached $227.8 million, a 53.6% increase compared to Q3 2024 [6][7] - Rare Disease total net revenues increased by 109.9% to $118.5 million, with Cortrophin Gel net revenues growing by 93.8% to $101.9 million [9][10] - Generics net revenues were $94.4 million, reflecting a 20.6% increase year-over-year, attributed to a successful partnered generic launch [4][10] Business Highlights - Cortrophin Gel's growth was supported by increased demand and the highest number of new patient starts since its launch, with significant contributions from specialties like neurology and rheumatology [8][9] - ILUVIEN net revenues were $16.6 million, impacted by reduced access for Medicare patients and ongoing adoption efforts [8][9] - The company is focused on advancing its Rare Disease business to drive long-term shareholder value and improve patient access [2][7] Guidance and Future Outlook - ANI has updated its full-year 2025 guidance, projecting total net revenues between $854 million and $873 million, with adjusted non-GAAP EBITDA expected to be between $221 million and $228 million [17][18] - The company anticipates gross margins to be between 61.0% and 62.0% for the full year [18] - Adjusted non-GAAP diluted earnings per share are expected to range from $7.37 to $7.64 [17][18]