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- **Record Growth**: Q3 2025 revenue up 54% YoY, driven by 93.8% surge in Cortrophin Gel to $101.9M.
- **Guidance Raise**: 2025 net revenue target $854-873M (+39-42%), Cortrophin Gel forecast $347-352M (+75-78%).
- **Generics Momentum**: Low 20% growth for 2025, though Q4 may dip due to competitive pressure.
- **ILUVIEN Reset**: 2026 focus on Medicare access and new label adoption, with 10x addressable patient potential.
- **Financial Strength**: $262.6M cash, 1.7x net leverage, and 59.2% adjusted EBITDA margin.

**【CEO Summary Section】**
- **Q3 2025 Performance**: Total revenue grew 54% YoY ($227.8M), with 46% organic growth. Adjusted EBITDA increased 70% to $59.6M. Cortrophin Gel net revenue reached $101.9M, up 93.8% YoY, driven by new patient starts and expanded sales force.
- **2025 Guidance Update**: Full-year net revenue expected to rise 39-42% to $854-873M. Cortrophin Gel forecasted at $347-352M (75-78% growth). Generics growth in low 20% range, though Q4 may dip due to competitive entrants.
- **Strategic Focus**: Rare Disease remains top priority. ILUVIEN faces Medicare access challenges but shows potential for 2026 growth with new label adoption and specialty pharmacy pathways.

**【CFO Financial Commentary】**
- **Q3 Financials**: GAAP net revenue $227.8M (53.6% YoY). Rare Disease segment contributed $118.5M, with Generics at $94.4M. Adjusted EBITDA margin 59.2%, down 63bps due to partnered generic product mix.
- **Cash Flow & Balance Sheet**: $262.6M in unrestricted cash. Full-year 2025 EBITDA guidance raised to $221-228M. Gross leverage 3x, net leverage 1.7x trailing EBITDA.
- **Generics Outlook**: Low 20% growth for 2025, but Q4 expected to decline due to competitive pressure on a key partnered product.

**【Q&A Highlights】**
- **Cortrophin Growth Drivers**: 42% sequential increase in ophthalmology volume. Prefilled syringe adoption at 70% of new cases. Addressable patient populations (e.g., acute gouty arthritis: 285K) underpenetrated, with half of prescribers new to ACTH.
- **Generics Challenges**: Q4 dip in Generics due to competitive entrants, but long-term pipeline remains strong.
- **ILUVIEN Strategy**: 2026 focus on peer-to-peer education, Medicare Part D access via specialty pharmacy, and NEW DAY study dissemination.
- **Sales Force Expansion**: ROI validated by record new patient starts. Pulmonology and neurology show growth potential.
- **Durability of Cortrophin**: Patents extend to 2040s; porcine-derived formulation poses high generic entry barriers.

ANI Pharmaceuticals, Inc. (ANIP) Q3 2025 Earnings Call Transcript

Revenue

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Financing Services Revenue

Other Revenue

Cost of Revenue

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Cost of Financing Services

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Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

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ANIP

ANIP fundamentals

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