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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 Surge**: Q2 revenue up 53% YoY to $211.4 million, with Cortrophin Gel driving 66% growth to $81.6 million. 2025 guidance raised to $818-$843 million.
- **Cortrophin Momentum**: 70% of new cases use prefilled syringe; ophthalmology volumes rose 33% QoQ. ACTH market projected to grow 36% to $933 million in 2025.
- **Retina Challenges**: Medicare access cuts 2025 retina guidance to $87-$93 million. NEW DAY trial data may expand ILUVIEN use but no near-term impact.
- **Generics Strength**: 22% YoY growth in Generics, but H2 moderation expected. Gross margin improved to 64.9%, targeting 63%-64% for 2025.
- **Balance Sheet**: $217.8 million cash, net leverage 2.2x. Focus on Rare Disease expansion and U.S. manufacturing efficiency.

**【CEO Summary Section】**
- **Record Q2 Performance**: Total net revenue reached $211.4 million, up 53% YoY, driven by 66% growth in Cortrophin Gel to $81.6 million. Adjusted non-GAAP EBITDA was $54.1 million, and EPS was $1.80.
- **Updated 2025 Guidance**: Total revenue raised to $818-$843 million (33%-37% growth), with Cortrophin Gel expected to reach $322-$329 million (63%-66% growth). Retina franchise guidance lowered to $87-$93 million due to Medicare access challenges.
- **Sales Team Expansion**: Portfolio sales team expanded from 52 to 70 members, leading to 54% QoQ growth in Cortrophin Gel. Prefilled syringe adoption reached 70% of new cases initiated.
- **Market Growth**: ACTH market projected to grow 36% to $933 million in 2025, with Cortrophin Gel capturing 57% of total company revenue in H2 2025. Over 50% of prescribers are new to ACTH therapy.

**【CFO Financial Commentary】**
- **Q2 Financials**: Generics revenue grew 22% YoY to $90.3 million, driven by prucalopride (180-day exclusivity). Brands revenue increased 32% YoY to $13.2 million. Gross margin improved to 64.9% due to Rare Disease mix and Generics pricing.
- **Balance Sheet**: Cash increased to $217.8 million, with net leverage of 2.2x trailing EBITDA. Full-year EBITDA guidance raised to $213-$223 million (37%-43% growth). U.S. GAAP tax rate expected at 24%-25%.
- **Guidance Details**: Generics growth expected to moderate in H2 due to prucalopride competitors. Brands revenue to normalize post-Q2 spike. R&D spend up 130% YoY to $16 million for Cortrophin trials and retina pipeline.

**【Q&A Highlights】**
- **Cortrophin Growth Drivers**: 33% QoQ growth in ophthalmology, 15% of use in acute gout flares, and 70% new cases with prefilled syringe. Over 50% prescribers are new to ACTH, supporting multiyear growth.
- **Retina Challenges**: Medicare co-pay funding gaps persist, impacting ILUVIEN/YUTIQ. NEW DAY trial data may support earlier DME use, but 2025 guidance reflects ongoing access issues.
- **Capital Allocation**: Prioritize organic growth and Rare Disease M&A. Gross margin expected to stabilize at 63%-64% in 2025, with focus on procurement and U.S. manufacturing efficiency.
- **Tariff Position**: 90%+ U.S.-manufactured products, <5% China imports. Strong balance sheet supports inventory levels amid regulatory uncertainty.


ANI Pharmaceuticals, Inc. (ANIP) Q2 2025 Earnings Call Transcript

- **Record Q1 Growth**: $197.1M revenue (+43% YoY), driven by generics (+41%), Cortrophin Gel (+43%), and rare disease expansion.
- **2025 Guidance Raised**: $768M-$793M (25%-29% growth), EBITDA $195M-$205M, reflecting generics strength and rare disease pipeline.
- **Cortrophin Momentum**: 40% new prescribers, pre-filled syringe launch, Phase IV gout study to validate acute flare use.
- **Retina Recovery**: April demand near Q4 2024 levels, Part D pathway and label expansion for ILUVIEN/YUTIQ.
- **Generics Dominance**: Prucalopride drives mid-double-digit growth, 90% U.S.-manufactured products shield from tariffs.

**【CEO Opening Remarks】**
- Q1 2025 revenue reached $197.1 million, up 43% YoY, driven by generics, Cortrophin Gel, and Brands portfolio.
- 2025 guidance raised to $768M-$793M (25%-29% growth) and EBITDA $195M-$205M, reflecting generics strength and rare disease growth.
- Cortrophin Gel Q1 revenue $52.9M (+43% YoY), with 40% prescribers new to ACTH category, targeting multi-year growth.
- Retina products (ILUVIEN/YUTIQ) Q1 $16.1M, impacted by Medicare access challenges but April demand near Q4 2024 levels.
- Generics Q1 $98.7M (+41% YoY), Prucalopride launch driving mid-double-digit annual growth.

**【Christopher Mutz - Rare Disease Update】**
- Cortrophin Gel: Record patient starts in Q1, pre-filled syringe launched in April, Phase IV gout study planned for 2025.
- ILUVIEN/YUTIQ: U.S. challenges due to Medicare Part B funding, but April demand recovery; expanded label for chronic NIU-PS approved.
- Ophthalmology salesforce optimized, with full strength expected Q2 2025.

**【Stephen Carey - Financial Review】**
- Q1 2025 non-GAAP EPS $1.70, EBITDA $50.7M, cash $149.8M post royalty buyout.
- 2025 guidance: Generics mid-double-digit growth, Brands normalization, rare disease 34%-38% Cortrophin growth.
- Gross margin 63.1% (down 130bps YoY due to royalty mix), operating expenses up 56.5% YoY for salesforce expansion.

**【Q&A Highlights】**
- **Cortrophin Syringe Impact**: Early positive feedback, launch in April, pricing premium but limited margin impact.
- **Retina Market Recovery**: April demand near Q4 2024, Part D pathway and specialty pharmacy solutions in progress.
- **Tariff Strategy**: 90% U.S.-made products, spare capacity to capitalize on supply chain disruptions.
- **Generic Growth**: Prucalopride Q1 peak, Q2 decline expected due to inventory management.
- **Competitor Dynamics**: Category growth 16% (ANI +34%-38%, competitor +7.5%), addressable market 6x-8x current volume.

ANI Pharmaceuticals (ANIP)-9 May 25-2025 Q1 Earnings call transcript

- **Record Q4 performance**: $190.6M revenue (+45% YoY), Cortrophin Gel at $59.4M (+42% YoY)
- **2025 guidance upgrade**: $756-776M total revenue (+23-26%), Cortrophin Gel to $265-274M (+34-38%)
- **Rare Disease dominance**: 54% of 2025 revenue, ILUVIEN/YUTIQ targeting $100M+ with 6-10x patient growth
- **Generics resilience**: 12% 2024 growth, 2025 outlook for low double-digit expansion
- **Strategic investments**: $190M+ in R&D, 46-territory ophthalmology sales force, Siegfried manufacturing expansion

**【CEO Summary Section】**
- Total Q4 2024 revenue: $190.6 million (45% YoY growth, 24% organic growth)
- 2025 revenue guidance: $756-776 million (23-26% YoY growth)
- Cortrophin Gel Q4 revenue: $59.4 million (42% YoY growth)
- 2025 Cortrophin Gel forecast: $265-274 million (34-38% YoY growth)
- Generics business 2024 growth: 12%, 2025 outlook: low double-digit growth
- Alimera acquisition: ILUVIEN/YUTIQ Q4 revenue $27.6 million, 2025 target $97-103 million
- Brands portfolio Q4 revenue: $19.8 million (59% YoY growth)

**【CFO Financial Commentary】**
- Q4 2024 non-GAAP EBITDA: $50 million (65% YoY growth)
- 2025 EBITDA guidance: $190-200 million (22-28% YoY growth)
- Non-GAAP gross margin: 63.5% (up 3.9ppt YoY)
- R&D expenses: $16.2 million (68% YoY growth)
- SG&A expenses: $54.8 million (42% YoY growth)
- Net debt: $639.2 million (2.5x net leverage)

**【Q&A Key Takeaways】**
- ILUVIEN/YUTIQ market access challenges: Medicare funding delays, but <5,000 patients on therapy vs 6-10x addressable population
- Cortrophin Gel gout indication: 15% of volume, 15% of new prescribers start with gout
- Rare Disease pipeline: $190 million+ investment in prefilled syringe, NEW DAY/SYNCHRONICITY trials
- Generics growth drivers: 17 new 2024 launches, prucalopride exclusivity, low double-digit volume growth
- M&A strategy: Maintain <3x net leverage, focus on rare disease
- Supply chain: ILUVIEN manufacturing expansion on track, YUTIQ transition to Siegfried by Q2 2025

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