ANI Pharmaceuticals: Record Results and Raised Guidance Signal Strong Growth Ahead

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) reported record financial results for the fourth quarter and full year 2024, marking a significant milestone in the company's strategic focus on rare diseases. The company's strong performance was driven by its lead rare disease asset, Purified Cortrophin Gel, and the successful integration of the Alimera Sciences acquisition, which added the durable ophthalmology franchise of ILUVIEN and YUTIQ to its portfolio.



Key financial highlights from the fourth quarter and full year 2024 include:

* Record quarterly net revenues of $190.6 million, representing year-over-year growth of 44.8%
* Total rare disease quarterly net revenue of $87.0 million, including:
+ Record quarterly net revenue for Purified Cortrophin Gel of $59.4 million, an increase of 42.3% year-over-year
+ ILUVIEN and YUTIQ net revenues of $27.6 million in the first full quarter of ownership following the acquisition of Alimera Sciences
* Record quarterly adjusted non-GAAP EBITDA of $50.0 million, an increase of 65.7% year-over-year
* Diluted GAAP loss per share of $(0.55) and adjusted non-GAAP diluted earnings per share of $1.63
* Increased 2025 guidance with expected net revenues of $756.0 million to $776.0 million and adjusted non-GAAP EBITDA of $190.0 million to $200.0 million; announced adjusted non-GAAP diluted earnings per share guidance of $6.12 to $6.49
* Rare disease net revenues expected to represent 48% to 49% of total company net revenues in 2025, including:
+ Purified Cortrophin Gel net revenues of $265.0 million to $274.0 million, representing year-over-year growth of 33.8% to 38.3%
+ ILUVIEN and YUTIQ net revenues of $97.0 million to $103.0 million



The strong performance of Purified Cortrophin Gel can be attributed to several key drivers, including market growth and share growth, increasing demand, expansion into new therapeutic areas, market development and physician education, and exclusivity in certain indications. The product's remarkable growth trajectory, with nearly $200 million in sales during 2024 just three years post-launch, demonstrates the sustainability of its strong performance.

The integration of the Alimera Sciences acquisition has significantly impacted ANI's financial performance and growth prospects, particularly for ILUVIEN and YUTIQ. In the first full quarter of ownership following the acquisition, these two products generated a combined net revenue of $27.6 million, contributing to the company's immediate revenue diversification and growth potential. The company's preliminary financial outlook for 2025 projects ILUVIEN and YUTIQ net revenues to reach $97.0 million to $103.0 million, indicating the successful execution of commercial, clinical, and operational initiatives to capture growth opportunities for these assets.

ANI Pharmaceuticals' strategic focus on rare diseases has enabled it to achieve higher margins, face less competition, tap into a growing market, diversify its product portfolio, and benefit from successful product performance. The company's strong financial performance and raised guidance for 2025 reflect its commitment to delivering sustainable growth and serving patients, improving lives. As ANI continues to execute on its strategic priorities and expand its rare disease portfolio, investors can expect the company to maintain its strong momentum and generate attractive returns.