Piper Sandler has initiated coverage on ANI Pharmaceuticals (ANIP), an integrated specialty pharmaceutical firm that develops and markets branded and generic medicines, with an ‘Overweight’ rating and a price target of $68. The analyst points out that ANI’s business model has undergone a significant transformation, shifting from a primary focus on generics to a new emphasis on integrating high-margin brand assets targeted at rare diseases.
Cortrophin Gel (adrenocorticotropic hormone (ACTH)), the company’s lead asset, has been the cornerstone of this evolution. Cortrophin gel sales more than doubled to $49.2 million in the second quarter of 2024, primarily driven by increased volume. The company has also raised its fiscal year 2024 Cortrophin gel outlook from $170 million-$180 million to $185 million-$195 million.
The FDA approved Cortrophin Gel in 2021 for the treatment of several autoimmune diseases. At the time, there was only one other ACTH player, Mallinckrodt Plc’s MNKTQ Acthar Gel. The company and the drug have faced challenges, including negative attention linked to Medicaid rebate-related litigation and settlement, and pandemic-related disruptions. When ANI launched Cortrophin Gel, it recognized significant promotion sensitivity associated with its relatively high price point, typically used after more affordable immunomodulatory alternatives. To address this, ANI developed a commercial framework focusing on essential specialty areas, patient support systems, and market access.
Earlier this year, ANI Pharmaceuticals acquired Alimera Sciences for $5.50 per share in cash and a non-tradable contingent value right (CVR) of up to $0.50 per share upon achieving certain net revenue targets in 2026 and 2027. With this acquisition, ANI gained Iluvien and Yutiq, both intravitreal implantable forms of the corticosteroid fluocinolone for diabetic macular edema and non-infectious uveitis. The analyst believes the acquisition was strategic, as ANI had already established commercial infrastructure aimed at ophthalmologists to promote Cortrophin Gel, which is indicated for various ophthalmic conditions. By incorporating Alimera’s current sales representatives, ANI can reach a wider pool of potential prescribers for Cortrophin Gel, due to the overlap with prescribers of Iluvien/Yutiq.
The analyst concludes that ANI is well-positioned to de-lever considerably from the Alimera transaction in the next 12-18 months. As of Friday’s close, ANIP stock is up 3.99% at $57.30.
