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- **EMROSI Dominance**: Q3 revenue up 75% to $4.9M, prescriptions +146% Q/Q to 18,198, with 2,700 prescribers (50% increase) and 1:1 refill/new prescription ratio.
- **Financial Turnaround**: EBITDA loss narrows to $500K (vs. $1M), targeting Q4 EBITDA positivity; $24.9M cash provides runway for growth.
- **Market Access Progress**: 100M+ lives covered, 2/3 GPOs contracted, with full coverage by early 2026.
- **Long-Term Ambition**: $200M+ U.S. peak sales for EMROSI, supported by 60% IGA success rate vs. Oracea.
- **Sustainability Signals**: Gross margin improving to 67.4%, OpEx growth constrained as revenue scales.


**【CEO Summary Section】**
- **Revenue Growth**: Total revenue reached $17.6 million, up 21% year-over-year, driven by EMROSI's 75% sequential increase to $4.9 million in Q3. EMROSI prescriptions surged from 7,394 in Q2 to 18,198 in Q3, with a 1:1 refill-to-new prescription ratio.
- **Product Momentum**: EMROSI achieved 146% prescription growth Q/Q, with 2,700 unique prescribers (50% increase from Q2). Refill rates are strong, indicating patient satisfaction and adherence.
- **Financial Milestone**: EBITDA improved to a loss of $500,000 in Q3 vs. $1 million in Q3 2024, with a target to become sustainably EBITDA positive in Q4.
- **Market Access**: 100 million of 187 million commercial lives now have EMROSI access, with 2/3 GPO contracts secured. Full GPO coverage expected early 2026.
- **Long-Term Vision**: EMROSI aims for $200M+ annual net sales in the U.S. and $300M+ globally, supported by superior efficacy (60% IGA success vs. Oracea) and favorable safety profile.

**【CFO Financial Commentary】**
- **Gross Margin**: 67.4% in Q3 (vs. 69.4% in Q3 2024), improving sequentially from 63.5% in Q1 to 67.4% in Q3, driven by higher-margin products.
- **Expense Management**: SG&A rose 6% to $12.1 million, reflecting EMROSI launch costs. Non-GAAP EBITDA turned positive at $1.7 million (vs. $0.3 million in Q3 2024).
- **Liquidity**: $24.9 million in cash, up from $20.3 million at year-end 2024, supporting continued investment in growth.

**【Q&A Highlights】**
- **Co-Pay Program Transition**: Reliance on co-pay assistance expected to decline as GPO contracts (final GPO in early 2026) drive broader payer coverage. Full formulary adoption may take 2-3 quarters post-contract.
- **Prescriber Depth/Breadth**: Focus on converting 2,700+ prescribers into consistent writers, with refill rates expected to outpace new prescriptions (target 1:3 ratio).
- **Accutane Stability**: Q3 revenue of $2.8 million shows stabilization amid generic competition, supported by brand recognition and promotional efforts.
- **Qbrexza Performance**: Remains top revenue generator, with single-digit growth despite new competition, benefiting from increased hyperhidrosis awareness.
- **Operating Leverage**: CFO expects OpEx growth to lag revenue, with EBITDA improving as EMROSI scales.


Fortress Biotech, Inc. (FBIO) Q3 2025 Earnings Call Transcript

- **Emrosi Launch Catalyst**: FDA-approved oral rosacea treatment set for Q2 2025 revenue contribution, targeting $200M U.S. peak sales.
- **Market Momentum**: 20% commercial payer coverage achieved pre-launch, with JAMA publication validating clinical superiority over Oracea.
- **Financial Resilience**: $20.3M cash balance post $22M one-time regulatory expenses, positioning for strong launch execution.
- **Growth Drivers**: Peer-reviewed clinical data and dermatologist engagement at AAD 2025 suggest strong adoption potential.

**【CEO Summary Section】**
- **2024 Financial Milestones**: Achieved annual revenue of $56 million, marking the sixth consecutive quarter of positive non-GAAP adjusted EBITDA. Received FDA approval for Emrosi, a best-in-class oral treatment for rosacea, with commercial launch set for early April 2025.
- **Emrosi Strategic Importance**: Projected peak annual sales of $200 million in the U.S. and $100 million internationally. The product's head-to-head Phase 3 clinical superiority over Oracea and favorable safety profile position it as a potential market leader in a $1 billion+ treatment category.
- **Market Engagement**: Generated strong interest at the 2025 AAD Conference, with dermatologists highlighting Emrosi's low-dose modified-release formulation and clinical trial results. JAMA Dermatology publication of Phase 3 data further validates Emrosi's efficacy and safety.

**【CFO Financial Commentary】**
- **2024 Financial Results**: Total net product revenue of $55.1 million, down 7.7% YoY due to higher rebate costs and legacy product volume declines. Non-GAAP adjusted EBITDA was $800,000, reflecting cost optimization efforts.
- **Key Expenses**: Incurred $22 million in one-time FDA filing fees and milestone payments to Dr. Reddy's. SG&A expenses decreased 8% YoY to $40.2 million, driven by operational efficiency improvements.
- **Balance Sheet Strength**: Ended 2024 with $20.3 million in cash, despite $14.7 million net loss, supported by $1 million milestone payment from Cutia Therapeutics for Amzeeq's China approval.

**【Q&A Key Highlights】**
- **Payer Coverage Progress**: 20% of 188 million commercial lives and 4% of 58 million Medicare lives covered as of early 2025, with expectations for significant growth throughout 2025. Market access team targeting 12-18 months to achieve peak coverage.
- **Emrosi Launch Dynamics**: Initial prescriptions dispensed, with Q2 2025 expected to show meaningful revenue contribution. No pricing changes observed from competitor Oracea post-launch.
- **Strategic Opportunities**: Exploring international licensing for Emrosi, with interest from potential partners outside the U.S. Continuing to leverage existing commercial infrastructure for efficient launch execution.

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