ANI PHARMACEUTICALS INC Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Strong start to 2025 with record revenue, adjusted EBITDA, and adjusted EPS.
• Raised 2025 guidance: Total revenues expected $768M-$793M (25%-29% growth vs 2024), adjusted non-GAAP EBITDA $195M-$205M (25%-31% growth vs 2024).
• Cortrophin Gel saw strong demand, with new patient starts and cases, and pre-filled syringe launch with positive early feedback.
• Retina products faced market access challenges but steps taken to refine commercial approach, including adding sales talent.
• Generics business driven by new product launches like Prucalopride.
• Discussed evolving tariff situation, highlighting U.S. manufacturing footprint with over 90% of revenues from U.S.-made goods.

Segment Performance

• Generics: First quarter revenues were $98.7 million, a 41% increase year-over-year. Driven by new product launches like Prucalopride Tablet with 180 days of exclusivity. Expect mid double-digit growth for the full year.
• Cortrophin Gel: Generated $52.9 million in Q1, up 43% year-over-year. Saw record new patient starts and cases. Expected 2025 revenues of $265 million to $274 million, representing 34%-38% growth. Growth across targeted specialties including ophthalmology.
• Retina Products (ILUVIEN and YUTIQ): Generated $16.1 million in Q1. Impacted by U.S. market access challenges but April end-user demand was higher. Maintaining 2025 outlook of $97 million to $103 million.
• Brands Portfolio: Performed well in Q1 but expected to return to normalized demand in Q2.

Guidance

• Raised 2025 total revenues to $768M-$793M (25%-29% growth vs 2024).
• Raised adjusted non-GAAP EBITDA to $195M-$205M (25%-31% growth vs 2024).
• Adjusted non-GAAP EPS between $6.27 and $6.62.
• Maintained ILUVIEN and YUTIQ revenue outlook at $97M-$103M.
• Generics expected mid double-digit growth, Brands to normalize in Q2.

Risks

• Market access challenges for retina products, particularly for Medicare patients due to co-pay support issues.
• Turnover in U.S. Ophthalmology salesforce initially impacted performance, though steps taken to add talent.
• Evolving tariff situation could impact, but company has strong U.S. manufacturing and balance sheet.
• Litigation with CG Oncology, jury trial set for July 2025.

Question and Answer

Q: On Cortrophin, how much pre-filled syringe helps and differentiation?

A: Pre-filled syringe reduces administration steps, early response positive. 20 reps doing well, evaluating high ROI initiatives.

Q: ILUVIEN challenges and turnover in optho sales team?

A: Market access issues addressed by exploring Part D and specialty pharmacy. Turnover being resolved with added talent, expecting full strength by Q2.

Q: NEW DAY trials and Prucalopride contribution?

A: Analyzing NEW DAY data for earlier DME treatment. Prucalopride contributed to Q1 generics growth, Q2 expected lower due to exclusivity end.

Q: Cortrophin indications and tariffs?

A: Growth across specialties, 40% new prescribers. U.S. manufacturing footprint can leverage spare capacity if tariffs enacted.

Q: Cortrophin indications and ILUVIEN Medicare?

A: Growth across all specialties. ILUVIEN Medicare subset impacted, but foundation support expected in H2.