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- **BRUKINSA leadership**: $1.1B Q3 revenue, 51% growth, solidifying global BTK dominance.
- **Sonro breakthrough**: 74% 6-year PFS vs. 62% for competitors, FDA Breakthrough Designation in MCL.
- **CDAC advantage**: 86% ORR, 79% 12-month PFS vs. 62% for competitors in CLL Phase III.
- **ZS combo dominance**: 92% uMRD at 1 year vs. 32% for AV, 4x faster MRD achievement.

**【CEO Summary Section】**
- BRUKINSA achieved $1.1 billion in Q3 revenue, up 41% YoY, solidifying its position as the global BTK leader with 51% Q3 growth.
- Sonro, the BCL-2 inhibitor, received FDA Breakthrough Therapy Designation in relapsed/refractory mantle cell lymphoma, with 74% 6-year PFS in CLL vs. 62% for competitors.
- 2025 guidance updated to $5.1-5.3 billion revenue, driven by BRUKINSA and sonro expansion.

**【CFO Financial Commentary】**
- Q3 2025 GAAP net income: $125 million; non-GAAP net income: $304 million, with $354 million free cash flow.
- BRUKINSA gross margin improved to 86%, supported by favorable product mix and cost efficiencies.
- 2025 R&D expenses: $1.1 billion, reflecting investment in late-stage assets like CDAC and sonro.

**【R&D & Pipeline Update】**
- CDAC (BTK degrader) Phase III vs. pirtobrutinib in relapsed CLL; 86% ORR, 79% 12-month PFS vs. 62% for competitors.
- Sonro Phase III ZS combo vs. AV in CLL: 92% uMRD at 1 year vs. 32% for AV, with 4-month MRD achievement vs. 16 months for AV.
- 10 new molecular entities advancing, including PRMT5 and B7-H4 ADCs with early POC in solid tumors.

**【Q&A Highlights】**
- BRUKINSA Europe growth: 70% Q3, but slower adoption in Germany due to guideline delays.
- CDAC Phase III in CLL expected H1 2026; targeting 12-month PFS readout for accelerated approval.
- Sonro combo ZS vs. AV in CLL: 74% 6-year PFS vs. 62% for AV, with no progression in 320mg cohort.
- GPC3 x 4-1BB ADC shows 83% ORR in PDAC, positioning for frontline trials in 2026.

BeOne Medicines AG (ONC) 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

ONC

ONC fundamentals

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