Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — Q1 2025 Earnings Presentation
54 slides from Beone Medicines Ltd. Class A's earnings presentation, May 7, 2025
Slide 1: Q1 2025 Results
Q1 2025 Results Conference call and webcast for investors and analysts MAY 7, 2025
Slide 2: Disclosures
Disclosures Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, constitute forward looking statements. Examples of such forward-looking statements include statements regarding
Slide 3: Agenda
Agenda Dan Maller 1 Welcome, Safe Harbor, and Agenda Head of Investor Relations John V. Oyler 2 CEO Business Update Co-Founder, Chairman and CEO Xiaobin Wu, Ph.D. 3 Global Commercial Update President and Chief Operating Officer Matt Shaulis 4 U.S. Commercial Update General Manager, North America Lai
Slide 4: CEO Business Update
CEO Business Update John V. Oyler Co-Founder, Chairman and CEO 4
Slide 5: Q1 Execution Sets Strong Foundation for 2025
Q1 Execution Sets Strong Foundation for 2025 Solidify and Deepen Advance Drive Hematology Prolific Superior Franchise Financial Pipeline Performance Leadership 5
Slide 6: Solidify & Deepen Heme Franchise: Foundational MOAs in CLL
Solidify & Deepen Heme Franchise: Foundational MOAs in CLL 2 3 1 BTKi Best-in-Class BTKi Backbone 6
Slide 7: BRUKINSA
1 BRUKINSA Recent Publications Support Best-in-Class Profile and Unmet Needs “A network meta-analysis of BTKis found zanubrutinib to be the most efficacious treatment for patients with high-risk R/R CLL.”1 1 Now the U.S. revenue leader “From the CLL experience, the BOVen triplet has achieved higher
Slide 8: Sonrotoclax
2 Sonrotoclax Sonrotoclax 1• Completed enrollment in Phase 3 CELESTIAL-TNCLL trial Potential Best-in-Class 2• Progressing two new Phase 3 trials1 BCL2i 3• Filed R/R CLL for accelerated approval in China and expect global filing in R/R MCL in H2 2025 4• Additional studies initiated on dose ramp-up op
Slide 9: BTK CDAC
3 BTK CDAC BTK CDAC Potential 1• Agreement with global regulators, including the FDA, for Phase 3 go-forward dose • First-in-Class • Best-in-Class 2• Initiation of Phase 3 trial in R/R CLL (vs. physicians' choice) 3• Phase 3 head-to-head trial vs. pirtobrutinib expected in H2 2025 4• 600+ patients e
Slide 10: Solid Tumor Pipeline: Q1 Updates
Solid Tumor Pipeline: Q1 Updates Solid Tumor Portfolio Upcoming Scientific Presentations 1• CDK4i – over 300 patients enrolled to date (+100 since last update) May 30 - June 3, 2025 2• B7-H4 ADC – completed seven monotherapy cohorts with multiple responses seen 3• First patients enrolled in Phase 1
Slide 11: POC Milestones Expected in 2025
POC Milestones Expected in 2025 Select POC Milestones in 20251 Breast and Gynecologic CDK4i CDK2i B7-H4 ADC 10+ POC Lung EGFR CDAC PanKRASi PRMT5i Milestones Gastrointestinal FGFR2b ADC CEA ADC Immunology and Inflammation IRAK4 CDAC small molecule inhibitor antibody drug conjug
Slide 12: Time, Cost and Quality Advantages
Time, Cost and Quality Advantages Driving significantly higher ROI for each R&D dollar spent 10 Dose escalation cohorts enrolled in Q1 2025 at average time of 7 weeks 30% Faster startup and database lock than industry benchmark1 30% CRO cost savings from internalized model2 0 No critical findings to
Slide 13: GAAP Profitability
Drive Superior Financial Performance • GAAP Operating Income 1 of $11M in Q1 vs. -$261M in PY GAAP Profitability • GAAP and Non-GAAP Earnings per ADS 2 of $0.01 and $1.22, respectively Achieved in Q1 2025 13
Slide 14: Well-Positioned for the Future
Well-Positioned for the Future Confidential. For internal use only. 14
Slide 15: Global Commercial Update
Global Commercial Update Xiaobin Wu, Ph.D. President and Chief Operating Officer 15
Slide 16: BRUKINSA and TEVIMBRA: Approved or Filed in Over 80 Markets
BRUKINSA and TEVIMBRA: Approved or Filed in Over 80 Markets Brukinsa and Tevimbra Approved Brukinsa Approved Brukinsa and Tevimbra Submission Brukinsa Submission 16
Slide 17: Diversified Revenue Mix and Growth Across All Markets
Diversified Revenue Mix and Growth Across All Markets $ in Millions (Q1 2025) Year-over-Year % Growth (Q1 2025) Revenue Mix Revenue Growth U.S. 567 U.S. 60% China 400 China 26% Europe 119 Europe 75% ROW 32 ROW 146% 17
Slide 18: U.S. Commercial Update
U.S. Commercial Update Matt Shaulis General Manager, North America 18
Slide 19: BRUKINSA: U.S. Revenue Leader & Fastest Growing Brand
BRUKINSA: U.S. Revenue Leader & Fastest Growing Brand $ in Millions (Q1 2025) Year-over-Year % Growth (Q1 2025) Revenue Revenue Growth BRUKINSA 563 +60% Ibrutinib 529 -13% Acalabrutinib 507 +3% 19
Slide 20: BRUKINSA Continued Strong Demand Growth in Q1 2025
BRUKINSA Continued Strong Demand Growth in Q1 2025 U.S. Total Demand Growth2 +120% +54% BRUKINSA is the BTKi class leader in new patient starts in CLL front line and R/R and all indications in the U.S.1 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Q4 2024 Q1 2025 1 Based on SHA Claims dat
Slide 21: BRUKINSA Positioned To Be Best BTKi for All Patient Types
BRUKINSA Positioned To Be Best BTKi for All Patient Types Nearly half of 1L CLL patients have BRUKINSA delivers powerful one or more high-risk features1: efficacy and consistent safety regardless of risk status • ~40% uIGHV2 • ~20% del(11q)3 • Superior efficacy vs BR in BRUKINSA has 1L CLL and vs ib
Slide 22: R&D and Pipeline Progress
R&D and Pipeline Progress Lai Wang, Ph.D. Global Head of R&D 22
Slide 23: We Are Evaluating Options for CLL Patients with Our Serial Innovation
We Are Evaluating Options for CLL Patients with Our Serial Innovation Treatment to progression Fixed-duration treatment 1L BRUKINSA sonrotoclax CLL + zanubrutinib 2L sonrotoclax sonrotoclax BTK-CDAC BRUKINSA CLL + BTK-CDAC + CD20 3L+ sonrotoclax sonrotoclax BTK-CDAC BRUKINSA CLL + CD20 + BTK-CDAC 23
Slide 24: Three Cornerstone Assets with Best-in-Class and/or First-in-Class Potential
Three Cornerstone Assets with Best-in-Class and/or First-in-Class Potential Zanubrutinib Sonrotoclax BTK CDAC Highest percent BTK receptor Higher potency to induce Most advanced BTK degrader occupancy/inhibition over deeper BCL2 inhibition may in the clinic with pivotal entire dosing interval contri
Slide 25: Compelling Fixed Duration Treatment with Sonro+Zanu
Compelling Fixed Duration Treatment with Sonro+Zanu Need to Meet High Efficacy and Safety Bars Efficacy Safety PFS comparable to BTKi Adding only minimal AEs What is needed? continuous therapy over BRUKINSA alone Physicians need to be comfortable when stopping therapy chance of relapse is minimal Ou
Slide 26: CELESTIAL-TNCLL (301): FD Sonro+Zanu vs. Ven+Obin
CELESTIAL-TNCLL (301): FD Sonro+Zanu vs. Ven+Obin Only Global Phase 3 Trial Designed to Demonstrate PFS Superiority over Current FD SOC Completed Enrollment in February 2025 sonrotoclax + Primary Endpoint Arm A zanubrutinib 12 cycles after 3 cycles • PFS zanubrutinib alone Previously untreated CLL R
Slide 27: CELESTIAL-RRCLL (303): Sonro+CD20 vs. Ven+CD20
CELESTIAL-RRCLL (303): Sonro+CD20 vs. Ven+CD20 A Head-to-Head Trial to Demonstrate Superiority of Sonrotoclax over Venetoclax First Patient Enrollment Planned for June 2025 Arm A sonrotoclax plus Primary Endpoint obinutuzumab n=~180 • PFS of SO vs VR Arm B sonrotoclax plus Active CLL/SLL, rituximab
Slide 28: CELESTIAL-RRMCL (302): Sonro+Zanu vs. Zanu
CELESTIAL-RRMCL (302): Sonro+Zanu vs. Zanu Phase 3 Global Study Design First Patient Enrolled in March 2025 zanubrutinib Primary Endpoint Arm A until progression / intolerance + • PFS sonrotoclax x 26 cycles R/R MCL Randomize 1:1 Key Secondary Endpoint N = 300 zanubrutinib • OS until progression Str
Slide 29: BTK CDAC Emerging as Potential Best-in-Class Post cBTKi
BTK CDAC Emerging as Potential Best-in-Class MOA Post cBTKi BTK CDAC: PFS by Investigator Pirtobrutinib: PFS by IRC1 Progression-free survival probability 100 100 Pirtobrutinib Progression-free survival probability 90 n-119 90 Number of events, n (%) 74 (62) 80 80 Median PFS, mo (95% CI) 14.0 (11.2-
Slide 30: CaDAnCe-304: BTK CDAC vs. Pirtobrutinib
CaDAnCe-304: BTK CDAC vs. Pirtobrutinib Global Phase 3 in R/R CLL/SLL Post-cBTKi First Patient Expected in H2 2025 CLL Dose for Phase 3 Agreed with FDA Primary Endpoint Arm A BTK CDAC 200 mg PO QD • PFS R/R CLL/SLL Randomize N = 500 1:1 Key Secondary Endpoints • OS Stratified factors: pirtobrutinib
Slide 31: BTK CDAC-104: Ph 1/2 Study in Multiple Heme Histologies
BTK CDAC-104: Ph 1/2 Study in Multiple Heme Histologies Platform Study with Multiple Internal and Collaboration Assets in Four Cohorts BTK CDAC + sonrotoclax Substudy 1 All BCM BTK CDAC + zanubrutinib Substudy 2 All BCM B-cell malignancies BTK CDAC + mosunutuzumab1 Substudy 3 FL and CLL/SLL BTK CDAC
Slide 32: Growing Portfolio in Three Major Solid Tumor Franchises
Growing Portfolio in Three Major Solid Tumor Franchises with Diverse Modalities and Mechanisms Lung Breast/Gynecologic GI Pan-Tumor PanKRASi CDK4i PanKRASi DGKζi MTA Cooperative CDK2i MTA Cooperative HPK1i 2G PRMT5i PRMT5i MAT2Ai BCL2i 2G MAT2Ai CCR8 mAb CEA ADC B7-H4 ADC FGFR2b ADC IL-15 prodrug B7
Slide 33: Key Late-Stage Catalysts in 2025 and 2026
Key Late-Stage Catalysts in 2025 and 2026 Asset Catalyst H1 2025 H2 2025 2026 BRUKINSA MANGROVE TN MCL Ph3 PFS interim analysis CELESTIAL-TNCLL (301) Ph3 enrollment completion (+BRUKINSA) ✓ CELESTIAL-RRCLL (303) Ph3 initiation (+CD20) Sonrotoclax CELESTIAL-RRMCL (302) Ph3 initiation (+BRUKINSA)
Slide 34: Key Early-Stage Catalysts in 2025 and 2026
Key Early-Stage Catalysts in 2025 and 2026 Asset Catalyst H1 2025 H2 2025 2026 PoC Data CDK4i 2L HR+/HER2- mBC Ph3 initiation PanKRASi PoC Data B7-H4 ADCa PoC Data EGFR CDAC PoC Data CDK2ib PoC Data B7-H3 ADC PoC Data CEA ADC PoC Data FGFR2b ADC PoC Data IRAK4 CDAC PoC Data PRMT5
Slide 35: More to Come at Our R&D Day on June 26, 2025
More to Come at Our R&D Day on June 26, 2025 June 26th at 8:30 A.M. EST in NYC and via webcast Featuring our innovative science and portfolio progression including details on our: Leadership in hematology Solid tumor portfolio evolution ASCO and EHA data updates Research innovation 35
Slide 36: Financial Results
Financial Results Aaron Rosenberg Chief Financial Officer 36
Slide 37: Q1 2025 Financial Highlights
Q1 2025 Financial Highlights Total Revenue Operating Income Cash Flow from Operations +49% GAAP Non-GAAP Operating Operating Income (Loss) Income (Loss)1 139 1,117 44 11 752 -147 -261 Q1 2024 Q1 2025 -309 Q1 2024 Q1 2025 Q1 2024 Q1 2025 Q1 2024 Q1 2025 1 Adjusted income (loss) from operations is a n
Slide 38: Q1 2025 Revenue Composition
Q1 2025 Revenue Composition US $M Q1 2025 Q1 2024 $ Change % Change Net product revenue 1,109 747 362 48 BRUKINSA 792 489 303 62 TEVIMBRA 171 145 26 18 Amgen in-licensed products 114 72 42 58 Other 32 41 (9) (22) Collaboration revenue 9 5 4 85 Total revenue 1,117 752 366 49 38
Slide 39: Q1 2025 Reported Profit and Loss (GAAP)
Q1 2025 Reported Profit and Loss (GAAP) US $M (except per ADS) Q1 2025 Q1 2024 $ Change % Change Product revenue 1,109 747 362 48 Collaboration revenue 9 5 4 85 Total revenue 1,117 752 366 49 Gross margin % 85% 83% Total operating expenses 941 888 53 6 R&D 482 461 21 5 SG&A 459 427 32 7 Income (loss
Slide 40: Q1 2025 Adjusted Profit and Loss (Non-GAAP)
Q1 2025 Adjusted Profit and Loss (Non-GAAP) US $M (except per ADS) Q1 2025 Q1 2024 $ Change % Change Product revenue 1,109 747 362 48 Collaboration revenue 9 5 4 85 Total revenue 1,117 752 366 49 Gross margin % 86% 84% Total operating expenses 817 778 39 5 R&D 421 405 16 4 SG&A 396 372 24 6 Adjusted
Slide 41: Reaffirm Full Year 2025 Financial Guidance
Reaffirm Full Year 2025 Financial Guidance Current FY 2025 FY 2025 Guidance1 Commentary • U.S. BRUKINSA leadership expansion Total Revenue $4.9 - $5.3B • Increasing global growth in EU/ROW • Assumes 4/30/2025 foreign exchange rates • Disciplined investment for growth with meaningful operating levera
Slide 42: John V. Oyler, Xiaobin Wu, Matt Shaulis, Lai Wang, Aaron Rosenberg
Aaron John V. Oyler Xiaobin Wu, Ph.D. Matt Shaulis Lai Wang, Ph.D. Rosenberg Co-Founder, President and General Manager, Global Head Chief Financial Chairman and Chief Operating North America of R&D Officer CEO Officer 42 BeiGene Confidential
Slide 43: Appendix
Appendix 43
Slide 44: Reconciliation and Calculation of Non-GAAP Financial Measures
Reconciliation and Calculation of Non-GAAP Financial Measures Reconciliation to Adjusted Income (Loss) from Operations Three months ended Three months ended US $M March 31, 2025 March 31, 2024 GAAP income (loss) from operations 11 (261) Plus: Share-based compensation 95 89 Plus: Depreciation expense
Slide 45: Reconciliation and Calculation of Non-GAAP Financial Measures
Reconciliation and Calculation of Non-GAAP Financial Measures Reconciliation to Adjusted Net Income (Loss) Three months ended Three months ended US $M March 31, 2025 March 31, 2024 GAAP net income (loss) 1 (251) Plus: Share-based compensation 95 89 Plus: Depreciation expense 32 24 Plus: Amortization
Slide 46: Reconciliation and Calculation of Non-GAAP Financial Measures
Reconciliation and Calculation of Non-GAAP Financial Measures Reconciliation to Adjusted EPS per ADS - Basic Three months ended Three months ended March 31, 2025 March 31, 2024 GAAP EPS per ADS - basic 0.01 (2.41) Plus: Share-based compensation 0.89 0.85 Plus: Depreciation expense 0.30 0.23 Plus: Am
Slide 47: Reconciliation and Calculation of Non-GAAP Financial Measures
Reconciliation and Calculation of Non-GAAP Financial Measures Reconciliation to Adjusted EPS per ADS - Diluted Three months ended Three months ended March 31, 2025 March 31, 2024 GAAP EPS per ADS - diluted 0.01 (2.41) Plus: Share-based compensation 0.86 0.85 Plus: Depreciation expense 0.28 0.23 Plus
Slide 48: Acronyms: A-G
Acronyms: A-G 1L 1st-line CRR Complete Response Rate 2L 2nd-line D A AA Accelerated Approval DLBCL Diffuse Large B-cell Lymphoma ADC Antibody Drug Conjugate E AML Acute Myeloid Leukemia EGFRmut EGFR Mutation AML/MDS Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS) EOT End of Treatment
Slide 49: Acronyms: H-P
Acronyms: H-P H mg Milligrams H2H Head-to-Head MM Multiple Myeloma HEME Hematology MoA Mechanism of Action HNSCC Head & Neck Squamous Cell Carcinoma MSS-CRC Microsatellite Stable Colorectal Cancer hPBMC Human Peripheral Blood Mononuclear Cells MZL Marginal Zone Lymphoma HR Hazard Ratio N HSPC Human
Slide 50: Acronyms: Q-Z
Acronyms: Q-Z Q TLS Tumor Lysis Syndrome Q1 First Quarter TN Treatment Naïve Q2 Second Quarter TN CLL Treatment Naïve Chronic Lymphocytic Leukemia Q3 Third Quarter TN MCL Treatment Naïve Mantel Cell Lymphoma Q4 Fourth Quarter TsAb Trispecific Antibody QD Once Daily U R UBC Urinary / Bladder Cancer R
Slide 51: Template Palette Colors
Template Palette Colors RGB Values Oxford Midnight Blue Blue 15,36,69 40,51,74 Primary Colors Oxford Midnight Red 214,43,30 Blue 15,36,69 Blue 40,51,74 *Use the eyedropper tool to select and apply Secondary Colors these colors, as they are not part Dark Blue* Cerulean Burgundy Autumn Sunflower* of t
Slide 52: Deleted slides
Deleted slides >>> To reduce file size, have put the previous versions here: BeOne Q1 2025 Earnings Deck DELETED SLIDES.pptx 52
Slide 53: CRO Gross Margins (1/2)
CRO Gross Margins (1/2) IQVIA (NYSE: IQV) Our Research & Development Solutions offerings include: Research & Development Solutions Segment Project Management and Clinical Monitoring. Drawing upon our years of experience, our site databases, our site relationships and our highly trained staff, our so
Slide 54: CRO Gross Margins 2/2
CRO Gross Margins 2/2 ICON (NASDAQ: ICLR) - No segment information available. Assume whole co GM of 29-30% Fortrea (NASDAQ: FTRE) – CRO spun out from LabCorp GM of ~20% Medpace (NASDAQ: MEDP) 54 Source: ICLR, FTRE, and MEDP 10K