ANI Pharmaceuticals: Strong Start to 2025 Driven by Cortrophin Gel and Generics

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has started the year on a strong note, with its lead Rare Disease asset, Purified Cortrophin Gel, and the Generics segment driving growth. The company has lifted its annual forecast, reflecting the positive momentum and its confidence in the continued success of these products. In the fourth quarter of 2024, ANI Pharmaceuticals generated record quarterly net revenues of $190.6 million, representing a 44.8% year-over-year increase (ANI Pharmaceuticals, Inc., 2025).

The strong performance of Purified Cortrophin Gel was a significant contributor to the company's overall growth. In the fourth quarter of 2024, Cortrophin Gel generated $59.4 million in net revenues, an increase of 42.3% year-over-year. This growth was driven by increased volume from both overall ACTH market growth and share growth, as well as the highest number of quarterly new patient starts and new cases initiated since launch (ANI Pharmaceuticals, Inc., 2025). The product's success can be attributed to its unique indications, such as acute gouty arthritis flares, for which Cortrophin Gel is the only approved ACTH therapy, and its ability to attract new prescribers, with approximately 40% of Cortrophin Gel prescribers being naïve to the ACTH category prior to prescribing the product.

The Generics segment also played a crucial role in ANI Pharmaceuticals' financial performance. In the second quarter of 2024, the Generics segment generated $73.964 million in revenue, representing a 16.8% increase from the same period in 2023. This growth was driven by the launch of four new products into limited competition markets and the expansion of the company's manufacturing capacity at its New Jersey site (ANI Pharmaceuticals, Inc., 2024). The company plans to maintain and enhance the growth of the Generics segment by continuing to launch new products into limited competition markets and expanding its manufacturing capacity.

The acquisition of Alimera Sciences and its products, ILUVIEN and YUTIQ, has also contributed to ANI Pharmaceuticals' Rare Disease segment. In the first full quarter of ownership, these products generated net revenues of $27.6 million, contributing to the total Rare Disease quarterly net revenue of $87.0 million (ANI Pharmaceuticals, Inc., 2025). The integration of ILUVIEN and YUTIQ is on track, and the overall Rare Disease business performed in line with expectations during the fourth quarter of 2024. ANI Pharmaceuticals believes there is significant room for growth for both ILUVIEN and YUTIQ, given their novel, long-acting nature and the size of the addressable markets (ANI Pharmaceuticals, Inc., 2025).

To maximize the potential of these products, ANI Pharmaceuticals is executing on commercial, clinical, and operational initiatives. These strategies aim to capture the growth opportunities presented by ILUVIEN and YUTIQ, which are expected to represent a significant portion of the company's Rare Disease net revenues in 2025 (ANI Pharmaceuticals, Inc., 2025).

In conclusion, ANI Pharmaceuticals' strong start to 2025, driven by the success of Purified Cortrophin Gel and the Generics segment, positions the company well for continued growth and success in the Rare Disease market. The company's strategic focus on expanding its Rare Disease and Brands segments, combined with its effective execution of growth strategies, has contributed to its robust financial performance. As ANI Pharmaceuticals continues to execute on its strategic priorities and maximize the potential of its products, investors can expect a strong performance from the company in the coming years.