Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — Q2 2025 Earnings Presentation
46 slides from Beone Medicines Ltd. Class A's earnings presentation, Aug 6, 2025
Slide 1: Q2 2025 Results
Q2 2025 Results Conference call and webcast for investors and analysts AUGUST 6, 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 1 Welcome, safe harbor, and agenda Dan Maller Head of Investor Relations 2 CEO business update John V. Oyler Co-Founder, Chairman and CEO 3 Financial results Aaron Rosenberg Chief Financial Officer 4 R&D and pipeline progress Lai Wang, Ph.D. Global Head of R&D 5 Q&A BeOne management team 3
Slide 4: CEO business update
CEO business update John V. Oyler Co-Founder, Chairman and CEO 4
Slide 5: Q2 2025: Strong execution driving sustainable growth
Q2 2025: Strong execution driving sustainable growth Financial and Pipeline highlights commercial highlights Revenue Key data presentations • $1.3B, +42% YoY • BRUKINSA Sequoia arms C + D BRUKINSA • BTK CDAC Earnings per ADS1 U.S. market leadership widens • CDK4i and B7-H4 ADC early activity • GAAP:
Slide 6: BRUKINSA is the U.S. revenue leader and fastest growing brand
BRUKINSA is the U.S. revenue leader and fastest growing brand U.S. cBTKI quarterly revenue ($M) Growth Approved $800 Revenue % y/y indications $700 $ 684 +43% 5 $600 Acalabrutinib 583 +5% 2 $500 Ibrutinib 543 -9% 3 $400 $300 $200 $100 $0 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Q2'25 So
Slide 7: BRUKINSA has cemented itself as a best-in-class medicine every step of the way
BRUKINSA has cemented itself as a best-in-class medicine every step of the way Human PK: the only BTKi that sustainably 1 inhibits BTK throughout the day ORR: superiority over ibrutinib that emerges at 2 early follow-up and is sustained PFS: the only BTKi to show PFS superiority over 3 ibrutinib in
Slide 8: BRUKINSA is the only BTKi that induces complete and sustainable BTK inhibition
1 BRUKINSA is the only BTKi that induces complete and sustainable BTK inhibition due to its potency and superior PK BRUKINSA PK vs. IC501 Acalabrutinib PK vs. IC 502 Ibrutinib PK vs. IC 503 BRUKINSA 160mg BID Acalabrutinib 100mg BID Ibrutinib 560mg QD 100 100 100 BRUKINSA 320mg QD Free fraction in P
Slide 9: BRUKINSA's differentiated potency and target coverage may drive higher clinical responses
2 BRUKINSA’s differentiated potency and target coverage may drive higher clinical responses Overall response rate (ORR) zanubrutinib ibrutinib P- value 2 P- value 2 <0.0001 0.0007 P- value 1 P- value1 0.0264 11.8% 10.5% 0.0121 7.5% 11.9% 88.4% 76.3% 80.4% 86.2% 76.6% 72.9% 75.7% 64.4% 15.3 3 24.2 4
Slide 10: BRUKINSA is the only BTKi to demonstrate PFS superiority over ibrutinib (ALPINE)
3 BRUKINSA is the only BTKi to demonstrate PFS superiority over ibrutinib in a head-to-head trial in R/R CLL (ALPINE) PFS in del(17p)/TP53 subset consistent PFS superiority in all-comer population1 with ITT patient population1 100.0 100.0 Progression-free survival probability Progression-free surviv
Slide 11: BRUKINSA's data supported by real-world evidence and recognized by KOLs
4 BRUKINSA’s differentiated data is supported by real-world evidence and recognized by leading CLL KOLs “This real-world study demonstrated that patients with “A network meta-analysis of BTKis found CLL treated with zanubrutinib had longer TTD, lower zanubrutinib to be the most efficacious treatment
Slide 12: BeOne is the only company with potentially best-in-class assets across three CLL MOAs
BeOne is the only company with potentially best-in-class assets across three foundational CLL MOAs Sustained CLL leadership BTKi BRUKINSA 12
Slide 13: Significant near-term milestones
Significant near-term milestones Pivotal data readouts 4 Sonro – 1st registrational filings (R/R CLL and R/R MCL) China ✓ Sonro - CELESTIAL 302 (RR MCL) and 303 (RR CLL) Ph 3 initiation ✓ and filings 1H 2025 BTK CDAC - CaDAnCe 302 (RR CLL) Ph 3 initiation ✓ 20+ Phase 3 trials CDK4i - early activity
Slide 14: Financial results
Financial results Aaron Rosenberg Chief Financial Officer 14
Slide 15: Q2 2025: Product revenue composition
Q2 2025: Product revenue composition Product revenue Commentary +41% YoY • BRUKINSA +49% y/y growth - Strong underlying demand growth while $1,302 maximizing value share $1,118 $1,109 $159 - Continued new patient share leadership1 $993 $136 $194 $921 $146 • TEVIMBRA +22% y/y $139 $154 $125 $171 $163
Slide 16: Q2 2025: Diversified revenue mix and growth across all markets
Q2 2025: Diversified revenue mix and growth across all markets $ in millions (Q2 2025) Year-over-year % growth (Q2 2025) Product revenue mix Product revenue growth U.S. 685 U.S. 43% China 429 China 23% Europe 152 Europe 87% ROW 36 ROW 168% 16
Slide 17: Q2 2025: Reported profit and loss (GAAP)
Q2 2025: Reported profit and loss (GAAP) US $M (except per ADS) Q2 2025 Q2 2024 $ Change % Change Product revenue 1,302 921 381 41 Collaboration revenue 13 8 5 65 Total revenue 1,315 929 386 42 Gross margin % 87.4% 85.0% Total operating expenses 1,063 898 165 18 R&D 525 454 70 15 SG&A 538 444 94 21
Slide 18: Q2 2025: Adjusted profit and loss (Non-GAAP)
Q2 2025: Adjusted profit and loss (Non-GAAP) US $M (except per ADS) Q2 2025 Q2 2024 $ Change % Change Product revenue 1,302 921 381 41 Collaboration revenue 13 8 5 65 Total revenue 1,315 929 386 42 Gross margin % 88.1% 85.4% Total operating expenses 886 746 139 19 R&D 444 383 62 16 SG&A 442 364 78 2
Slide 19: Updated full year 2025 financial guidance
Updated full year 2025 financial guidance Prior Current FY 2025 FY 2025 Guidance1 FY 2025 Guidance1 Commentary • U.S. BRUKINSA leadership expansion Total Revenue $4.9 - $5.3B $5.0 - $5.3B • Increasing global growth in EU/ROW • Assumes 6/30/2025 foreign exchange rates • Disciplined investment for gro
Slide 20: R&D and pipeline progress
R&D and pipeline progress Lai Wang, Ph.D. Global Head of R&D 20
Slide 21: Recap of Investor R&D Day 2025
Recap of Investor R&D Day 2025 21
Slide 22: Significant recent progress across the pipeline
Significant recent progress across the pipeline Submissions and approvals Clinical progressions BRUKINSA Hematology oncology • Tablet formulation - U.S. approval and CHMP positive opinion • Key data reports at ASCO, EHA and ICML for SEQUOIA Arm D and Arm C, S+Z in TN CLL and BTK CDAC in RR CLL and R
Slide 23: Comprehensive registrational program to address all CLL segments
BeOne has comprehensive registrational program to address all CLL segments for treatment naïve and relapsed settings Indication Treatment Study details Phase 2 Phase 3 Approval Continuous use Zanubrutinib monotherapy vs. BR Approved TN CLL/SLL Fixed duration Zanubrutinib + sonrotoclax vs. VO Ongoing
Slide 24: Sonrotoclax: potentially best-in-class BCL2 inhibitor
Sonrotoclax: potentially best-in-class BCL2 inhibitor CELESTIAL 303: (vs. VO) Better potency, better selectivity, and +anti-CD20 Phase 3 R/R CLL/SLL potentially more convenient to use CELESTIAL 302: (vs. zanu) +zanubrutinib Phase 3 R/R MCL 14-fold more potent, deeper CELESTIAL 301 (vs. VO) target in
Slide 25: Zanubrutinib + sonrotoclax achieved deep response and impressive PFS in TN CLL/SLL
Zanubrutinib + sonrotoclax (ZS) achieved deep response and impressive PFS in TN CLL/SLL1 TN CLL/SLL uMRD by week 482,3 100% 4% 6% 8% 9% 8% 90% 12% Progression-free survival probability (%) 80% No PFS events at 320mg dose and only one progression 70% at 160mg dose 92% 94% 91% 100% 92% 60% Patients (n
Slide 26: ZS has best-in-class potential vs. VO, IV, and AV
ZS has best-in-class potential vs. VO, IV, and AV on efficacy, safety, and convenience TN CLL/SLL Precedent fixed duration ZS1 VO2 VO3 IV4 IV5 AV7 Population all comers unfit fit unfit all comers fit uMRD 91% 76% 87% 55% 77% 34% Not currently 100% approved in U.S. 36-mo PFS 24 mo. PFS 82% 88% 77% 90
Slide 27: BTK CDAC: potential first-in-class and best-in-class BTK degrader
BTK CDAC: potential first-in-class and best-in-class BTK degrader Most advanced BTK degrader in the clinic CaDAnCe 304 (vs. pirto) with pivotal programs initiated Monotherapy Phase 3 start-up R/R CLL/SLL CaDAnCe 302, 3031 (vs. inv choice) Degradation can Monotherapy Phase 3 R/R CLL/SLL overcome and
Slide 28: Emerging data for R/R CLL supports H2H trial of BTK CDAC vs. pirtobrutinib
Emerging data for R/R CLL provides confidence to conduct H2H superiority trial of BTK CDAC vs. pirtobrutinib R/R CLL BGB-16673: PFS by investigator1 Pirtobrutinib: PFS by IRC2 100 Progression-free survival probability Progression-free survival probability 100 Pirtobrutinib 90 n=119 90 80 Median PFS,
Slide 29: Development programs in non-CLL hematology indications
Development programs in non-CLL hematology indications Indication Regimen Early clinical development Registrational trial Approval TN MCL Zanubrutinib + rituximab Ongoing Zanubrutinib monotherapy Approved R/R MCL Sonrotoclax monotherapy Filed* Zanubrutinib + sonrotoclax Ongoing TN WM Zanubrutinib mo
Slide 30: Solid tumor pipeline includes diverse modalities and mechanisms
Our solid tumor pipeline includes diverse modalities and mechanisms across disease franchises Breast/Gynecologic Lung Gastrointestinal Lung CDK4i Pan-KRASi Pan-KRASi CDK2i MTA Cooperative PRMT5i MTA Cooperative PRMT5i BCL2i MAT2Ai MAT2Ai KAT6A/Bi* CEA ADC FGFR2b ADC B7-H4 ADC B7-H3 ADC CEA ADC Claud
Slide 31: 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)1 ✓ CELESTIAL-RRMCL (302) Ph3 initiation (+BRUKINSA) ✓ Sonrotoclax CELESTIAL-RRCLL (303) Ph3 initiation (+anti-
Slide 32: 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 1L HR+/HER2- mBC Ph3 initiation B7-H4 ADC1 POC Data ✓ Ph3 initiation Pan-KRASi POC Data EGFR CDAC POC Data CDK2i2 POC Data B7-H3 ADC POC Data CEA ADC POC Data
Slide 33: BeOne management team
John V. Oyler Xiaobin Wu, Ph.D. Co-Founder, President and Chairman and CEO Chief Operating Officer Aaron Rosenberg Lai Wang, Ph.D. Chief Financial Officer Global Head of R&D Matt Shaulis Mark Lanasa General Manager, Chief Medical Officer, North America Solid Tumors 33
Slide 34: Appendix
Appendix 34
Slide 35: Reconciliation to adjusted income from operations
Reconciliation and calculation of Non-GAAP financial measures Reconciliation to adjusted income (loss) from operations Three months ended Three months ended US $M June 30, 2025 June 30, 2024 GAAP income (loss) from operations 88 (107) Plus: Share-based compensation 151 131 Plus: Depreciation expense
Slide 36: Reconciliation to adjusted net income
Reconciliation and calculation of Non-GAAP financial measures Reconciliation to adjusted net income (loss) Three months ended Three months ended US $M June 30, 2025 June 30, 2024 GAAP net income (loss) 94 (120) Plus: Share-based compensation 151 131 Plus: Depreciation expense 30 24 Plus: Amortizatio
Slide 37: Reconciliation to adjusted EPS per ADS - basic
Reconciliation and calculation of Non-GAAP financial measures Reconciliation to adjusted EPS per ADS - basic Three months ended Three months ended June 30, 2025 June 30, 2024 GAAP EPS per ADS - basic 0.87 (1.15) Plus: Share-based compensation 1.39 1.25 Plus: Depreciation expense 0.28 0.23 Plus: Amor
Slide 38: Reconciliation to adjusted EPS per ADS - diluted
Reconciliation and calculation of Non-GAAP financial measures Reconciliation to adjusted EPS per ADS - diluted Three months ended Three months ended June 30, 2025 June 30, 2024 GAAP EPS per ADS – diluted1 0.84 (1.13) Plus: Share-based compensation 1.34 1.23 Plus: Depreciation expense 0.27 0.22 Plus:
Slide 39: Reconciliation to free cash flow
Reconciliation and calculation of Non-GAAP financial measures Reconciliation to free cash flow Three months ended Three months ended US $M June 30, 2025 June 30, 2024 Net cash provided by (used in) operating activities (GAAP) 264 (96) Less: Purchases of property, plant and equipment (44) (110) Free
Slide 40: BRUKINSA differentiation: list of preclinical publications
BRUKINSA differentiation: list of preclinical publications Year Type Journal/meeting Lead author Title 2015 Poster AACR Ning Li BGB-3111 is a novel and highly selective Bruton’s tyrosine kinase (BTK) inhibitor 2016 Poster AACR Zhijian Sun CD40L-CD40 Signaling on B cell Lymphomas Response to BTK Inhi
Slide 41: BRUKINSA differentiation: list of RWE and MAIC publications
BRUKINSA differentiation: list of RWE and MAIC publications Year Type Journal/meeting Lead author Title Clinical Lymphoma, Bijal Shah MCL-509 Indirect Comparison of Efficacy of Zanubrutinib Versus Acalabrutinib in the Treatment of Relapsed/Refractory 2024 Manuscript Myeloma and Leukemia (R/R) Mantle
Slide 42: ALPINE – overall responses by IRC over time
ALPINE – overall responses by IRC over time ALPINE (zanubrutinib vs ibrutinib) ORR IA ORR FA PFS FA Final Analysis Z I Z I Z I Z I (N=207) (N=208) (N=327) (N=325) (N=327) (N=325) (N=327) (N=325) Median FU 15.3 months 24.2 months 29.6 months 42.5 months ORR ( IRC ) 76.3% 64.4% 80.4% 72.9% 86.2% 75.7%
Slide 43: ASPEN – overall responses over time
ASPEN – overall responses over time ASPEN (zanubrutinib vs ibrutinib) Primary Efficacy Analysis (2020) Final Analysis (2023) R/R TN Overall Overall Z I Z I Z I Z I (N=83) (N=81) (N=19) (N=18) (N=102) (N=99) (N=102) (N=99) Median FU 19.4 months 19.4 months 19.4 months 44.4 months VGPR or CR 29% 20% 2
Slide 44: 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 45: 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 46: 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