ANI Pharmaceuticals Inc (NASDAQ:ANIP) reported first-quarter adjusted earnings of $1.70 per share on Friday, up from $1.21 a year ago, beating the consensus of $1.38 per share.

The company reported sales of $197.12 million, up 43.4% year over year, beating the consensus of $180.68 million. On an organic basis, excluding the acquisition of Alimera, total net revenues grew 31.7% year-over-year.

Net revenues for rare diseases, which include Cortrophin gel, Iluvien, and Yutiq, increased by 86.7% to $69.0 million. Cortrophin Gel net revenues increased 43.1% to $52.9 million, driven by increased volume.

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During the quarter, the company saw increasing demand with the highest number of new patient starts and new cases initiated since launch. Cortrophin Gel experienced growth across existing and new prescribers, and ANI continued to expand the overall base of Cortrophin Gel prescribers. Iluvien and Yutiq generated net revenues of $16.1 million. 

Performance for retina assets outside the U.S. was in line with expectations. Performance in the U.S. was impacted by reduced access for Medicare patients due to a lack of funding for third-party co-pay assistance programs, turnover in our sales force, and seasonality. 

Brands’ net revenues decreased 2.2% to $25.1 million, driven by a modest net decrease in volume.

Net revenues for Generic pharmaceutical products increased 40.5% to $98.7 million, driven by increased volumes in the base business and contributions from new product launches.

Reported gross margin decreased from 64.2% to 62.9%. Adjusted gross margin decreased from 64.4% to 63.1%, primarily due to mix, including significant growth of royalty-bearing products, including Cortrophin Gel.

Nikhil Lalwani, President and CEO, commented, “Based on our first quarter performance and favorable demand trends for Cortrophin Gel and our Generics and Brands portfolio, we are raising our 2025 guidance for total revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS. While we await more visibility on potential pharmaceutical industry-specific tariffs, we believe we are well-positioned based on our strong U.S. footprint with over 90% of our revenues coming from finished goods manufactured in the U.S. and less than 5% of our revenues with direct reliance on China.”

Guidance: ANI Pharmaceuticals raised its 2025 revenue guidance from $756 million to $776 million to $768 million to $793 million, versus the consensus of $769.64 million.

The company expects adjusted EBITDA of $195 million to $205 million compared to prior guidance of $190 million to $200 million.

ANI Pharmaceuticals expects 2025 adjusted EPS of $6.27 to $6.62 versus prior guidance of $6.12 to $6.49 and a consensus of $6.34.

Price Action: ANIP stock is down 4.95% to $67.99 at the last check on Friday.

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