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- **Revenue Growth**: Q3 2025 net product revenues up 103% YoY to $851 million, driven by 135% TTR franchise expansion.
- **Guidance Increase**: 2025 net product revenue raised to $2.95B-$3.05B (midpoint +10%), reflecting AMVUTTRA ATTR-CM launch strength.
- **U.S. Launch Momentum**: AMVUTTRA ATTR-CM Q3 net sales $543 million (+100% QoQ), with 90% U.S. patients within 10 miles of treatment.
- **Pipeline Progress**: ZENITH hypertension trial initiated; ALN-6400 Phase II in HHT; MAPT Phase I in Alzheimer's.
- **Financial Discipline**: Non-GAAP operating income $476 million (+128% YoY); cash balance $2.7 billion post-refinancing.

**【CEO Summary Section】**
- Q3 2025 total net product revenues reached $851 million, up 103% YoY, driven by 135% growth in the TTR franchise.
- AMVUTTRA ATTR-CM U.S. launch doubled Q3 net revenues to $543 million, with patient demand increasing 100% QoQ.
- 2025 net product revenue guidance raised to $2.95B-$3.05B (midpoint +10%), reflecting strong U.S. and rare disease franchise performance.
- Emphasized TTR leadership, innovation pipeline (e.g., zilebesiran in hypertension), and financial discipline.

**【CFO Financial Commentary】**
- Q3 GAAP net income: $420 million; Non-GAAP EPS: $1.08 (vs. $0.85 prior year).
- Gross margin on product sales: 77% (down 3% YoY due to AMVUTTRA royalty rate increase).
- Non-GAAP R&D expenses: $310 million (+23% YoY) for pipeline trials (e.g., ZENITH, TRITON).
- Non-GAAP SG&A: $263 million (+35% YoY) for U.S. launch investments.
- Cash balance: $2.7 billion post-refinancing; 2025 operating expense guidance narrowed to $2.15B-$2.2B.

**【CCO Commercial Update】**
- U.S. TTR franchise Q3 net sales: $543 million (+194% YoY), with AMVUTTRA ATTR-CM contributing ~$300 million.
- Ex-U.S. TTR revenues: $181 million (+46% YoY), led by Japan and Germany launches.
- Rare disease franchise: $127 million (+14% YoY) despite ex-U.S. competition.
- Health system setup complete; 90% U.S. patients within 10 miles of treatment site.
- Payer coverage broad (0 out-of-pocket for most patients); no headwinds anticipated in 2026.

**【Q&A Highlights】**
- **Payer Dynamics**: No pushback seen; 2026 policies align with U.S. launch experience.
- **Ex-U.S. Pricing**: Japan pricing favorable; Germany negotiations ongoing.
- **Pipeline Updates**: ALN-6400 Phase II in HHT, MAPT Phase I in Alzheimer's, and ZENITH Phase III for hypertension.
- **Competitive Position**: Maintaining >50% first-line share in hATTR-PN despite new competition.
- **Legal Update**: Cooperating with U.S. Attorney's Office subpoena on government price reporting.

Alnylam Pharmaceuticals, Inc. (ALNY) 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

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Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

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Income (Loss) from Associates

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Gain (Loss) on Change in Fair Value

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Other Non-Operating Income (Loss)

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Net Income from Continuing Operations

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Other Items Before Net Income

Net Income

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Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

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Other Comprehensive Income

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Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

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Diluted EPS from Discontinued Operations

ALNY

ALNY fundamentals

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