ANI Pharmaceuticals Rides Rare Disease Wave to Record Results

In a quarter marked by strategic execution and resilience, ANI Pharmaceuticals (NASDAQ: ANIP) delivered 43.4% year-over-year revenue growth, driven by its Rare Disease franchise and a robust Generics division. The Q1 2025 results underscore a company transitioning into a rare disease leader while navigating near-term headwinds in its ophthalmology portfolio.

The Rare Disease Renaissance

The Rare Disease segment, led by Cortrophin Gel, emerged as the growth engine, contributing $69.0 million in revenue (+86.7% YoY). Cortrophin Gel, used to treat infantile spasms and acute gouty arthritis flares, saw $52.9 million in sales (+43.1% YoY), fueled by record new patient starts and expanded prescriber adoption. Over 40% of prescribers were new to the ACTH category, signaling strong physician education efforts. The launch of a FDA-approved prefilled syringe formulation in April 2025, designed to simplify administration, has already garnered positive feedback.

CEO Nikhil Lalwani emphasized the drug’s momentum: “Cortrophin Gel’s 15% penetration in acute gouty arthritis reflects its broadening utility, and we’re now targeting underserved markets like chronic gout and post-surgical pain.”

Generics: A Steady Growth Pillar

The Generics division grew 40.5% YoY to $98.7 million, driven by new launches like prucalopride tablets (first-to-market with 180 days exclusivity) and strong performance in core products. This segment’s expansion highlights ANI’s ability to capitalize on niche opportunities in a crowded generic market.

Challenges in Ophthalmology, but Light at the End of the Tunnel

The ILUVIEN/YUTIQ retina therapies faced headwinds in Q1, generating only $16.1 million in U.S. sales due to Medicare access hurdles and sales team turnover. However, management noted improving demand trends in Q2, including progress on a label expansion for ILUVIEN (now approved for chronic non-infectious uveitis, previously exclusive to YUTIQ). The company also bought out its royalty obligations on these products in March 2025, reinforcing its commitment to this portfolio.

Financial Fortitude and Raised Guidance

• Adjusted Non-GAAP EBITDA rose 34.9% YoY to $50.7 million.
• Diluted GAAP EPS reached $0.69, while adjusted EPS hit $1.70 (+40.5% YoY).
• Full-year 2025 revenue guidance was raised to $768 million–$793 million, with Rare Disease expected to account for 47–48% of total revenue.
• Cortrophin Gel’s annual guidance was increased to $265 million–$274 million, reflecting confidence in its new-patient pipeline.

Risks and Strategic Mitigation

• Supply Chain Resilience: ANI manufactures 90% of its products domestically, reducing exposure to tariffs or geopolitical risks.
• Medicare Access: The company is actively addressing hurdles for ILUVIEN/YUTIQ through sales force optimization and label expansion.
• SG&A Pressures: Costs rose 59.4% YoY due to the Alimera acquisition integration, but these are expected to stabilize in 2025.

Conclusion: A Buy on Growth Catalysts

ANI’s Q1 results demonstrate a clear shift toward Rare Disease as its growth driver, with Cortrophin Gel positioned for sustained momentum. The Generics division’s outperformance and strategic acquisitions like Alimera provide a diversified revenue stream, while supply chain resilience mitigates macro risks.

While near-term challenges in ophthalmology remain, the label expansion and royalty buyout signal long-term confidence in this portfolio. With adjusted non-GAAP EPS guidance raised to $6.27–$6.62 (up 21–27% YoY), and a $149.8 million cash balance as of March 2025, ANI is well-positioned to execute its growth roadmap.

Investors should monitor Cortrophin Gel’s new-patient adoption rates and ILUVIEN/YUTIQ’s Q2 sales recovery. At current valuations, ANIP’s fundamentals align with its growth trajectory, making it a compelling play on rare disease innovation and operational discipline.

For a company once known for generics, ANI’s Rare Disease renaissance is no longer a side note—it’s the headline.