ANI PHARMACEUTICALS INC Q3 FY2024 earnings call

• Strong Q3 performance with total revenues of $148.3 million, up 13% y-o-y. - Completed acquisition of Alimera on September 16, which is highly synergistic to the Rare Disease business. - Integration of Alimera's ophthalmology sales force is progressing, with a 45-person combined team promoting products since mid-October. - Cortrophin Gel continues to show strong growth, with highest new patient starts and unique prescribers since launch. - Developed pre-filled syringe for Cortrophin Gel, submitted supplemental NDA, and plans to launch in H1 2025. - Generics business launched five new generics in Q3, with one additional in Q4 and several ANDAs submitted. - R&D progress with Cortrophin Gel, including research presentations and publications.

Rare Disease Segment: Cortrophin Gel generated $52.6 million in revenues during Q3 2024, up 77% from Q3 2023. The segment also included revenues from ILUVIEN and YUTIQ of $3.9 million from the two-week period post-Alimera acquisition. Generics Business: Generated revenues of $78.2 million in Q3 2024, up 11% from Q3 2023. Cortrophin Gel's revenue contribution to the Rare Disease segment was significant, with a 77% y-o-y increase, and the generics business contributed through steady new product launches.

• Full-year 2024 net revenues revised to $594 million to $602 million (previously $540-560M), up ~22-24% y-o-y. - Cortrophin net revenues revised to $196 million to $200 million (previously $185-195M), up 75-78% y-o-y. - Combined ILUVIEN and YUTIQ net revenues expected to be $30 million to $32 million (post-Alimera acquisition period). - Adjusted non-GAAP EBITDA revised to $149 million to $153 million (previously $140-150M), up ~11-14% y-o-y. - Adjusted non-GAAP EPS expected to be between $4.90 and $5.05.

• Supply chain challenges related to YUTIQ and addressing FDA warnings, but working closely with EyePoint to resolve. - General risks associated with forward-looking statements, including actual results differing from projections.

Q: Talk about payer landscape for Cortrophin Gel, evolution compared to Acthar Gel, mix of growth from new vs existing prescribers, and generics launch cadence for 2025.

A: Nikhil Lalwani mentioned maintaining strong payer relationships, growth from both new and existing prescribers, and generics business to continue high-single to low-double digit growth via R&D and operational excellence.

Q: For ILUVIEN and YUTIQ, guidance from Alimera close, Q4 run rate, acceleration plans, and NEW DAY study impact.

A: Nikhil and Chris Mutz discussed Q4 implied guidance, transition period for commercial organization, NEW DAY study's potential to revisit DME treatment approach.

Q: Impact of combined sales team on Cortrophin ophthalmology, pre-filled syringe benefit.

A: Nikhil noted early positive signs from combined sales team in ophthalmology and pre-filled syringe to enhance patient convenience.

Q: Learnings from Alimera acquisition for future M&A.

A: Nikhil emphasized sticking to strategic alignment, addressing challenges during acquisition, and working through supply chain issues related to YUTIQ