ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) reported strong first-quarter results for 2025, generating record total revenues of $197.1 million, up 43.4% year-over-year. This increase was driven by robust sales across multiple segments, particularly in rare diseases and generics. Total rare disease revenues reached $69.0 million, representing an 86.7% increase from the prior year, with Cortrophin Gel alone contributing $52.9 million—a 43.1% rise.

The company’s generics business recorded revenues of $98.7 million, a year-over-year increase of 40.5%. Adjusted non-GAAP EBITDA for the quarter was $50.7 million, up 34.9% compared to the same period in 2024. Adjusted non-GAAP earnings per share were reported at $1.70, compared to $1.21 a year prior.

Looking ahead, ANI has raised its 2025 guidance for total revenues to a range of $768 million to $793 million, an increase from prior estimates of $756 million to $776 million. The updated guidance reflects growth expectations of approximately 25% to 29% over 2024. Additionally, adjusted non-GAAP EBITDA is projected to be between $195 million and $205 million, compared to the previous estimate of $190 million to $200 million. This translates to growth of 25% to 31% over the prior year.

Cortrophin Gel is anticipated to generate annual revenues of $265 million to $274 million, reflecting a year-over-year growth of 34% to 38%. Meanwhile, revenue expectations for ILUVIEN and YUTIQ are maintained in the $97 million to $103 million range, in line with previous estimates.

The company reported a gross margin of 63.1%, a decline of approximately 130 basis points from the prior year, primarily attributed to the increased proportion of royalty-bearing products. Operating expenses rose significantly—selling, general, and administrative expenses increased by 56.5% to $63.7 million due to investments associated with expanding sales initiatives and integration costs from the Alimera acquisition.

As of March 31, 2025, ANI’s unrestricted cash totaled $149.8 million, and the company held $637.2 million in outstanding debt. The leverage ratio is at 3.5 times on a gross basis and approximately 2.7 times net. The company anticipates continued strong performance within its generics division, projecting mid-double-digit growth for the full year.

With guidance now updated, ANI Pharmaceuticals aims to leverage its strong financial position while navigating market challenges, including dynamics within the Medicare landscape impacting some product sales. The outlook for the remainder of 2025 suggests a cautious but steady approach toward achieving planned growth across its segments.