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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 Growth Accelerates**: $1.3B Q2 revenue (+42% YoY), driven by BRUKINSA's U.S. leadership and global expansion.
- **BRUKINSA Dominance**: #1 BTK inhibitor with 35% YoY demand growth, ALPINE trial showing 34% lower progression risk vs ibrutinib.
- **Pipeline Momentum**: 2026 milestones include sonro global filings, BTK CDAC Phase III readouts, and 10+ proof-of-concept data releases.
- **Financial Strength**: 87% gross margin, $253M non-GAAP net income, and $5-5.3B full-year revenue guidance.
- **Innovation Focus**: 10+ solid tumor NMEs in clinic, CDK4 Phase III delayed to 2026 for optimization.

**【CEO Summary Section】**
- Q2 2025 revenue reached $1.3 billion, up 42% YoY, driven by BRUKINSA's U.S. leadership and global expansion. GAAP EPS grew $2 YoY to $0.84, with $220M free cash flow.
- BRUKINSA solidified as #1 BTK inhibitor in the U.S., with 35% YoY demand growth. ALPINE trial data showed 34% lower risk of progression vs ibrutinib, with no cardiac deaths.
- Hematology franchise leadership extended with sonro (next-gen BCL-2 inhibitor) and BTK CDAC degrader. Solid tumor pipeline expanded with 10+ NMEs in clinic.
- 2026 milestones include global sonro filings, BTK CDAC Phase III readouts, and 10+ proof-of-concept data releases.

**【CFO Financial Commentary】**
- Q2 GAAP gross margin improved to 87% (vs 85% Q1), driven by TEVIMBRA cost efficiencies and BRUKINSA tablet launch.
- Operating expenses rose 18% to $1.1B, reflecting R&D and commercial investments. Full-year revenue guidance updated to $5-5.3B, with GAAP gross margin 80-82%.
- Free cash flow positive for the year, supported by $253M non-GAAP net income and $2.25 EPS.

**【R&D & Pipeline Update】**
- Sonro (BCL-2 inhibitor) filings in China for CLL and MCL, with global MCL Phase III planned. Zanidatamab + sonro combo achieved 92% uMRD in CLL, with 25.5-month PFS.
- BTK CDAC degrader showed 2-year median PFS in CLL, outperforming pirtobrutinib in cross-trial analysis.
- Solid tumor pipeline expanded with CDK4, B7-H4 ADC, and PRMT5 inhibitors, targeting breast, lung, and GI cancers.

**【Q&A Highlights】**
- BRUKINSA U.S. net pricing stable, with 35% YoY demand growth despite competitor discounts. Tablet launch reduces COGS and improves patient convenience.
- Pirto (pirtobrutinib) BRUIN314 data non-inferior to ibrutinib, but insufficient to challenge BRUKINSA's frontline leadership.
- CDK4 Phase III start delayed to early 2026 for dose optimization. Zanidatamab + sonro data to be presented at SABCS 2025.

BeOne Medicines Ltd. (ONC) Q2 2025 Earnings Call Transcript

- **GAAP Profit Milestone**: Q1 2025 marks first GAAP profitability with $1.1B revenue (+49% YoY).
- **BRUKINSA Market Leadership**: U.S. BTK market leader by revenue, +60% YoY growth, and PFS superiority in high-risk CLL.
- **Sonro Regulatory Progress**: China filing submitted; global filings planned for H2 2025 in CLL and MCL.
- **Pipeline Momentum**: 10+ solid tumor POC readouts expected; BTK CDAC Phase III vs pirtobrutinib initiated.
- **Financial Strength**: GAAP net income $420M; Non-GAAP EPS $1.22; 2025 guidance for $4.9B-$5.3B revenue and cash flow positivity.


**【CEO Business Update】**
- BeiGene achieved GAAP profitability for the first time in Q1 2025, with revenue of $1.1 billion, up 49% YoY.
- BRUKINSA became the U.S. BTK market leader by revenue, driven by 60% YoY growth and leadership in new patient starts across all CLL lines.
- Sonro (BCL-2 inhibitor) reached a regulatory filing milestone in China and plans for global filings in H2 2025.
- BTK CDAC program initiated Phase III trials against pirtobrutinib, with over 600 patients dosed globally.
- Solid tumor pipeline expects over 10 proof-of-concept readouts in 2025, including CDK4, B7H4, and claudin-6 bispecifics.

**【Global Commercial Progress】**
- U.S. sales: BRUKINSA ($563M, +60% YoY) and TEVIMBRA ($171M, +18% YoY) led growth.
- China: TEVIMBRA and BRUKINSA maintained market leadership with 26% YoY growth.
- Europe: 75% YoY growth, driven by BRUKINSA and TEVIMBRA launches.
- Rest of World: $32M (+146% YoY) growth from Latin America, Asia-Pacific, and MENA expansions.

**【U.S. Commercial Performance】**
- BRUKINSA Q1 demand growth: 54% YoY, 6% QoQ, with leadership in new patient starts across frontline and relapsed CLL.
- BRUKINSA's PFS advantage in high-risk CLL (59% vs 32% vs ibrutinib) supports market share expansion.
- Fixed-duration combination of BRUKINSA + sonro positioned to address unmet needs in CLL.

**【R&D and Pipeline Progress】**
- Sonro Phase III trials: CELESTIAL-301 (frontline CLL) completed enrollment; CELESTIAL-303 (relapsed CLL) vs venetoclax in CD20 combo.
- BTK CDAC: Phase III trial vs pirtobrutinib initiated; platform studies combining with sonro, zanu, and CD20 bispecifics.
- Solid tumor pipeline: CDK4 inhibitor enrolling >300 patients; B7H4 monotherapy shows clinical activity; PRMT5 inhibitor enters clinic.

**【Financial Highlights】**
- Q1 2025 GAAP net income: $420M; Non-GAAP EPS: $1.22 (vs $0.00 prior year).
- Product gross margin: 85% (up 2ppt YoY) due to favorable mix and cost efficiencies.
- Operating expenses: $941M (+6% YoY), disciplined investment in R&D and commercial growth.
- Full-year 2025 guidance: $4.9B-$5.3B revenue, GAAP operating breakeven, positive cash flow.

**【Q&A Key Takeaways】**
- CDK4 program: Designed to be more potent than Pfizer's atirmociclib; Phase III in second-line HR+ breast cancer planned.
- BRUKINSA beyond oncology: Phase III in membranous nephropathy; no plans for autoimmune diseases.
- Supply chain: $800M Hopewell, NJ manufacturing expansion; API sourced from Switzerland and Spain to mitigate tariffs.
- CLL competition: BRUKINSA maintains leadership vs pirtobrutinib due to head-to-head data and safety profile.
- Solid tumor pipeline: 10+ POC readouts expected, with CDK4, B7H4, and claudin-6 bispecifics as key inflection points.


BeiGene, Ltd. (ONC) Q1 2025 Earnings Call Transcript

- **Revenue Milestone**: $3.8 billion annual revenue, $1.1 billion Q4, with BRUKINSA driving 100% U.S. growth.
- **Market Leadership**: BRUKINSA leads CLL new patient starts (50%+ U.S. share) and surpasses competitors in U.S. revenue within two years.
- **Pipeline Momentum**: 13 new molecular entities in 2024; CDK4/6 inhibitor Phase 1 data and BTK degrader head-to-head trial expected in 2025.
- **Financial Sustainability**: Positive Q4 cash flow, 2025 guidance of $4.9-5.3 billion, and GAAP operating breakeven target.
- **Strategic Focus**: Hematology franchise expansion, cost-efficient clinical development, and value-focused R&D investments.

**【CEO Summary Section】**
- Full-year 2024 revenue reached $3.8 billion, with Q4 revenue of $1.1 billion, driven by BRUKINSA's 100% YoY growth in the U.S. and 97% growth globally.
- BRUKINSA achieved leadership in CLL new patient starts (over 50% U.S. share) and surpassed competitors in U.S. revenue within two years of approval.
- Strategic focus on hematology franchise expansion, pipeline advancement (13 new molecular entities in 2024), and financial sustainability (positive Q4 cash flow from operations).

**【CFO Financial Commentary】**
- Q4 2024 GAAP net revenue: $1.1 billion (+77% YoY), with BRUKINSA contributing $828 million (100% YoY growth).
- Full-year 2024 product gross margin: 85.6%, up 2.4ppt YoY due to favorable mix and cost efficiencies.
- 2025 guidance: $4.9-5.3 billion in revenue, with GAAP operating breakeven and positive cash flow from operations.
- Operating expenses: $1 billion in Q4 (+55% YoY), reflecting R&D investments and pipeline expansion.

**【Q&A Highlights】**
- **BRUKINSA Market Share**: U.S. revenue surpasses competitors; Q4 2024 U.S. sales up 97% YoY, driven by new patient starts and label expansion.
- **Fixed-Duration Treatments**: BRUKINSA's head-to-head data vs. competitors (e.g., AMPLIFY) shows superior efficacy and safety, positioning it as the preferred continuous therapy.
- **Pipeline Progress**: CDK4/6 inhibitor Phase 1 data expected H1 2025; BTK degrader head-to-head trial vs. pirdanilb planned for H2 2025.
- **Financial Strategy**: Focus on operating leverage (product revenue growth 5x faster than expenses in Q4) and disciplined capital allocation to sustain growth and profitability.


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