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- **FDA CRL Impact**: U.S. Simponi launch delayed to H1 2026, reducing 2025 revenue guidance by 10% to $570M-$600M.
- **Manufacturing Response**: 93% of FDA corrective actions completed; Joseph McClellan leads COO efforts to ensure compliance.
- **Pipeline Strength**: 12 late-stage biosimilars, including H1 2026 launches in Europe, targeting $185B markets.
- **Financial Resilience**: Q3 EBITDA $68M; 2026 growth intact with $43M cash and $100M working capital facility.
- **Regulatory Shift**: Skipping efficacy trials accelerates pipeline for Keytruda, Cimzia, etc., with 15 new cell lines in development.

**【CEO Presentation】**
- Received FDA CRL for Simponi biosimilar due to manufacturing issues at Reykjavik facility, delaying U.S. launch to H1 2026. Facility remains FDA-approved for other products.
- Appointed Joseph McClellan as COO to oversee manufacturing improvements, with 93% of FDA's 180+ corrective actions completed.
- Revised 2025 guidance: $570M-$600M revenue (down 10% YoY) and $130M-$150M EBITDA (down 12% YoY), driven by production delays and delayed licensing deals.
- Strong pipeline with 5 approved biosimilars, 12 in late-stage development, and 15 new cell lines targeting $185B originator markets.

**【Joseph McClellan - Pipeline Update】**
- Upcoming launches: AVT06 (Eylea) in Europe post Nov 23, AVT05 (Simponi) in Europe by end-Q4, AVT03 (Prolia/Xgeva) in Europe/Q4. Japan launches for AVT05 and AVT03 in H1 2026.
- New candidates for Hemlibra and Imfinzi in process development, with 15 cell lines for future targets.

**【Linda Jonsdottir - Financial Overview】**
- Q3 2025: $420M revenue (24% YoY growth), $68M EBITDA (16% margin). Licensing revenue $81M (69% gross margin).
- Cash balance $43M, with $100M working capital facility to support inventory builds.
- R&D spend elevated in Q3 ($16M+), expected to moderate in Q4.

**【Q&A Highlights】**
- CRL impact: temporary production slowdown, no lost partner interest. 2026 outlook remains strong with committed orders outside U.S.
- Manufacturing: 93% of FDA actions completed; facility improvements ongoing.
- Regulatory changes: Skipping efficacy trials for biosimilars accelerates pipeline development for Keytruda, Cimzia, etc.
- R&D spend: Q3 elevated due to clinical manufacturing and launch prep; Q4 expected to decline.

Alvotech (ALVO) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

ALVO

ALVO fundamentals

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