ANI Pharmaceuticals, Inc. Q2 FY2025 earnings call

Management Statement and Operational Highlights:

• This was a record-setting quarter for ANI with all-time highs in net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS.
• The Rare Disease team saw strong growth with Cortrophin Gel demand accelerating, new patient starts and new cases initiated reaching new highs. The sales team for Cortrophin was expanded to 70 members, and the prefilled syringe for Cortrophin Gel was launched in April.
• The retina portfolio generated $22.3 million in Q2, with efforts to improve market access for Medicare patients and execute on ILUVIEN initiatives. The NEW DAY clinical trial of ILUVIEN in earlier-stage DME was presented at ASRS.
• The Generics business had strong performance with new product launches contributing to growth.

Segment Performance:

• Rare Disease: In Q2, revenues were $104 million, up 111% year-over-year. Cortrophin Gel had revenues of $81.6 million, up 66% year-over-year and 54% from Q1 2025. ILUVIEN and YUTIQ generated $22.3 million in Q2. Rare Disease is expected to account for approximately 57% of total company net revenues in the second half of 2025.
• Generics: Revenues were $90.3 million in Q2, up 22% year-over-year, driven by new product launches including prucalopride with 180-day CGT exclusivity.
• Brands: Revenues were $13.2 million in Q2, up 32% year-over-year.

Guidance:

• Raised 2025 total net revenues to $818 million to $843 million (previously $768 million to $793 million).
• Adjusted non-GAAP EBITDA is expected to be $213 million to $223 million (previously $195 million to $205 million).
• Adjusted non-GAAP earnings per share is between $6.98 and $7.35 (previously $6.27 and $6.62).
• Cortrophin Gel net revenue is raised to $322 million to $329 million (previously $265 million to $274 million).
• Combined ILUVIEN and YUTIQ net revenue is revised to $87 million to $93 million (previously $97 million to $103 million).

Risks:

• Market access challenges for retina drugs in Medicare patients have persisted, impacting prescribing.
• Litigation with CG Oncology: ANI commenced a civil action against CG Oncology, but the jury returned a verdict in favor of CG Oncology in July 2025, and ANI intends to appeal.

Question and Answer: Q: Congrats on the great quarter. Given the strength in Cortrophin, any seasonality or onetime benefits? Any plans to add sales force? Upside in ophthalmology and gout?

A: Nikhil Lalwani stated there was no seasonality or onetime benefit; no immediate plans to add sales team members; there is strong upside potential in ophthalmology and gouty arthritis flares with a large total addressable market.

Q: Just wanted to ask for a little more granularity on what exactly is driving the kind of pretty meaningful inflection to expansion of the ACTH class?

A: Nikhil Lalwani mentioned factors like the expansion of the Cortrophin sales team, acceleration in newer indications like gout, revenue synergies in ophthalmology, and rapid uptake of the prefilled syringe for Cortrophin Gel.

Q: Another question on Cortrophin Gel. And I think you touched upon this in the prepared remarks. But just between the growth that you're seeing and your competitors are seeing, just any thoughts on how quickly the category overall could kind of get back to that $1.2 billion peak that I think we saw in 2017?

A: Nikhil Lalwani stated ANI believes the market can go well past the previous peak, driven by substantial room for patient expansion, new indications like acute gouty arthritis flares, and increased prescribers using Cortrophin Gel.