Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — Q4 2024 Earnings Presentation
51 slides from Beone Medicines Ltd. Class A's earnings presentation, Feb 27, 2025
Slide 1: Full Year and Q4 2024 Results
Full Year and Q4 2024 Results Conference call and webcast for investors and analysts February 27, 2025 1
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
Welcome, Safe Harbor and Dan Maller AGENDA Agenda Head of Investor Relations CEO Opening Remarks and Hematology John V. Oyler Franchise Update Co-Founder, Chairman and CEO Matt Shaulis U.S. Commercial Update on BRUKINSA General Manager, North America Lai Wang, Ph.D. R&D and Pipeline Progress Global
Slide 4: CEO Opening Remarks and Hematology Franchise Update
C E O O P E N I N G R E M A R K S A N D H E M AT O L O G Y F R A N C H I S E U P D AT E John V. Oyler Co-Founder, Chairman and CEO 4 4
Slide 5: Global Oncology Powerhouse at Major Inflection Point
Global Oncology Powerhouse at Major Inflection Point 2024: KEY MILESTONES Positive $3.8B #1 BTK 13 NMEs cash flow a FY 2024 revenue in the U.S.b entered clinic in 2024 Heme Franchise Leadership Pipeline Global and Sustainable Financial maturity BRUKINSA is #1 BTK in the U.S.b: Rapid revenue growth H
Slide 6: Uniquely Built to Address an Increasingly Challenged Industry
Uniquely Built to Address an Increasingly Challenged Industry Built strategically advantaged Industry challenges capabilities designed to pressuring R&D returns improve R&D returns Increasing trial costs Internal global clinical team of ~3,700 CRO oncology trial cost-per-patient increased from ~$100
Slide 7: Our Focus in 2025
Our Focus in 2025 1. Solidify and deepen hematology leadership 2. Advance pipeline of internally developed assets 3. Drive superior financial performance 7
Slide 8: BRUKINSA Designed From Inception To Be Best-in-Class
BRUKINSA Designed From Inception To Be Best-in-Class Scientific hypothesis: complete and sustained BTK inhibition would result in best-in-class profile BRUKINSA PK vs. IC 501 Ibrutinib PK vs. IC502 Acalabrutinib PK vs. IC 503 BRUKINSA 160 mg BID Ibrutinib 560mg QD 100 Acalabrutinib 100mg BID 100 BRU
Slide 9: Highest BTK Occupancy Including After Dosing Interruptions
Highest BTK Occupancy Including After Dosing Interruptions May Meaningfully Contribute to Observed Higher Efficacy for BRUKINSA Predose 48 hours Just published (trough steady state) (post last dose) PEER REVIEWED “ % Patients with BTK occupancy in PBMC > 95% Zanubrutinib 160 mg BID 93.7 37.2 Quantit
Slide 10: Head-to-Head Study Proves Only BRUKINSA Superior to Ibrutinib
Consistent With Best-in-Class Design, Phase 3 Head-to-Head Study Proves Only BRUKINSA Superior1 to Ibrutinib* BRUKINSA vs. ibrutinib Acalabrutinib vs. ibrutinib PFS in ALPINE Del17p/TP53 populationa PFS in ELEVATE-RR Del17p population2 100 HR (95% CI): 100 HR (95% CI): 0.48 (0.31, 0.75) 1.00 (0.73,
Slide 11: Growing CLL Leadership: Fixed Duration Compelling, But Requires:
Growing CLL Leadership: Fixed Duration Compelling, But Requires: Deep response (measured by uMRD) 1 Physicians need to be comfortable when stopping therapy that chance of relapse is minimal (VO data sets range from 75-85%) Impressive and sustained PFS 2 Comparable to continuous BTKi therapy Safety d
Slide 12: AMPLIFY Data Did Not Show Deep MRD Response
Growing CLL Leadership: AMPLIFY Data Did Not Show Deep 1 MRD Response Undetectable Minimal Residual Disease (uMRD) Precedent Amplify4 Z+S5 Fixed Duration VO1 VO2 VI3 AV AVO Chemo Zanu + sonro 75% 81%, 85% 55% 34.4%a 67.1%a 45.5%a 91%a unfit fit unfit fit fit fit All Comers 1 CLL14 Fischer et al NEJM
Slide 13: Current Fixed Duration Options Do Not Show Comparable PFS
Growing CLL Leadership: Current Fixed Duration Options 2 Do Not Show Comparable PFS to Continuous BRUKINSA Continuous BTKi1 Precedent Amplify5 fixed duration BRUKINSA VO2 VO3 VI4 AV AVO Chemo 36-month PFS 84.3%a 82% 88% 77% 76.5%b 83.1%c 66.5% 42-month PFS 83% 78% 85% 74.6% ~69% ~82% ~62% 60-month P
Slide 14: BRUKINSA Monotherapy Has Proven Sustained Efficacy While AMPLIFY Is Underwhelming
BRUKINSA Monotherapy Has Proven Sustained Efficacy 2 While AMPLIFY Is Underwhelming and Could Deteriorate Further SEQUOIAa 1L unfit CLL, ITT Z vs. BR AMPLIFYb 1L fit CLL, ITT AV/AVO vs. FCR/BR 61.2 months follow-up/ Median age 70 40 months follow-up/ Median age 61 100 100 84.3% 90 (79.0, 88.4) 80.1%
Slide 15: Fixed Duration Options Have Challenging Safety Profile
3 Growing CLL Leadership: Current Fixed Duration Options Have Challenging Safety Profile During Treatment Precedent Continuous BTKi Amplify5 fixed duration BRUKINSA1 VO2 VO3 VI4 AV AVO Chemo All Grade ≥3 TEAEs 39.2% 78.8% 83.1% 75.5% 53.6% 69.4% 60.6% Grade ≥3 Infections 9.6% 17.5% 14% 17% 12.4% 23.
Slide 16: Growing CLL Leadership: Fixed Duration Combination
Growing CLL Leadership: Fixed Duration Combination Differentiated sonrotoclax (BCL2i) with zanubrutinib - deep, durable responses, and favorable safety Update post-JPM: fully enrolled Phase 3 CELESTIAL trial Deep responses with ZS PFS - impressive and sustained with ZSb Acceptable safety profile • N
Slide 17: BTK CDAC Emerging as Potential Best-in-Class Degrader
BTK CDAC Emerging as Potential Best-in-Class Degrader Initiating Phase 3 head-to-head trial in 2025 vs. pirtobrutinib BGB-16673: PFS by Investigator Pirtobrutinib: PFS by IRC1 100 Pirtobrutinib Progression-free survival probability Progression-free survival probability 90 n-119 80 Number of events,
Slide 18: Driving Serial Innovation to Build Sustainable CLL Franchise
Driving Serial Innovation to Build Sustainable CLL Franchise We are poised to advance CLL standard of care with best-in-class molecules and combinations Building a best-in-class portfolio creates uniquely Key CLL MOA differentiated, sustainable franchise to address competitor LoE and IRA challenges
Slide 19: U.S. Commercial Update on BRUKINSA
U . S . C O M M E R C I A L U P D AT E O N B R U K I N S A Matt Shaulis General Manager, North America 19 19
Slide 20: BRUKINSA Now #1 in U.S. New CLL Patient Prescriptions
BRUKINSA Now #1 in U.S. New CLL Patient Prescriptions New patient share in U.S. CLL treatment naïve and relapsed/refractory1 70% 60% 50% ALPINE ASH presentation; 40% CLL FDA approval Acalabrutinib 30% Superior R/R PFS label update 20% SEQUOIA ASH presentation 10% Ibrutinib 0% 2021 2022 2023 2024 1 B
Slide 21: BRUKINSA Rapidly Approaching Value Share Lead in Growing U.S. BTKi Market
BRUKINSA Rapidly Approaching Value Share Lead in a Growing U.S. BTKi Market U.S. cBTKI Quarterly Revenue (millions) U.S. Q4 Revenue ($M) $1,200 $1,000 Ibrutinib $625 $573 $616 $800 Ibrutinib Acalabrutinib Brukinsa $600 U.S. Q4 Growth % vs. PY $400 97% Acalabrutinib 20% $200 -8% $0 Ibrutinib Acalabru
Slide 22: BTKi Leadership Is the Foundation for Our Broader CLL Franchise Strategy
BTKi Leadership Is the Foundation for Our Broader CLL Franchise Strategy US CLL New Patient Starts1 aCD20+/-Other 12% Brukinsa 25% Chemo+/-aCD20 11% Ven (BCL2) Calquence 25% 20% Jaypirca Imbruvica 4% 3% 1 CLL New Patient Starts (All Lines Q4 ’24) Source: Symphony Health Claims (SHS Polaris) 22
Slide 23: R&D and Pipeline Progress
R&D AND PIPELINE PROGRESS Lai Wang, Ph.D. Global Head of R&D 23 23
Slide 24: Transforming Our Pipeline With the Next Wave of Innovation
Transforming Our Pipeline With the Next Wave of Innovation Significant portfolio evolution in three years Heme leadership with 3 cornerstone assets Solid Tumor diversification from IO to disease-focused pipeline POC data readouts for many NMEs in the next 1-2 years Prior to 2022 2022 2023 2024 2025
Slide 25: Unprecedented R&D Productivity and Multiple Modalities
Unprecedented R&D Productivity and Multiple Modalities BeiGene’s number of NMEs surpassing peers1 2024 NMEs spanned diverse modalities Pharma 1 12 10 5 13 Pharma 2 7 9 Small • CDK2i Protein • IRAK4 CDAC Biotech 1 13 1 Molecules • PanKRASi Degraders • EGFR CDAC • MAT2Ai Pharma 3 6 7 Pharma 4 4 8 Biot
Slide 26: Redesigned Global Clinical Development with Internal Team
Redesigned Global Clinical Development with Internal Team, to Maximize Speed, Quality, and Efficiency CRAs across 371 countries and regions Fast to PoC Fast to Completion – Inflection for Early Development – Large Global Phase 3 10 months from initiation Close to 700 pts, 20 of GLP tox to enter coun
Slide 27: Several Wholly Owned, Internally Developed Assets With Value Inflection Points
Several Wholly Owned, Internally Developed Assets With Value Inflection Points on the Horizon Each has potential to become a meaningful value driver Together, they offer potential for combinations and franchise-building in lung, breast, and GI cancers PRMT5 CDK4 PanKRAS B7H4 EGFR and IRAK4 inhibitor
Slide 28: BGB-43395 (CDK4i)
1. BGB-43395 (CDK4i) Next-generation CDK4 inhibitor aiming for better efficacy and less toxicity in breast cancer • BGB-43395 is potential best-in-class CDK4 inhibitor that spares CDK6 mediated off-target toxicities Strong pharmacodynamic activity observed in breast cancer patients • 180+ patients e
Slide 29: BGB-53038 (panKRASi)
2. BGB-53038 (panKRASi) Potential best-in-class approach to target entire spectrum of KRAS mutations • KRAS mutations present in 19% of cancers, with CRC, NSCLC, and pancreatic cancer priority Robust activity in KRAS dependent cell lines, tumor types yet spares KRAS independent cells KRAS G12D KRAS
Slide 30: BG-C9074 (B7H4-ADC)
3. BG-C9074 (B7H4-ADCa) Potential first-in-class ADC for patients with B7-H4 expressing tumors • Validated ADC target with high tumor selectivity and limited target expression in Clinical response in 51-year-old patient with normal tissues advanced ovarian cancer with 4 prior lines of treatment • Ex
Slide 31: BGB-60366 (EGFR CDAC)
4. BGB-60366 (EGFR CDAC) Differentiated MoA to completely abolish EGFR signaling • First-in-class degrader that both inhibits Broadest EGFRmut coverage while sparing WT EGFR driver mutations and broadly covers TKI WT LR D19 LT DT LC DC LTC DTC resistance mutations* BG-60366 • Designed to be highly p
Slide 32: BGB-58067 (PRMT5i) and BG-89894 (MAT2Ai)
5. BGB-58067 (PRMT5i) and BG-89894 (MAT2Ai)a Potential best-in-class inhibitors: MTA-cooperative PRMT5 and MAT2Ai synergistically combine • Both MTA-cooperative PRMT5i and MAT2Ai induce cell death in tumors with MTAP-deletion, BG PRMT5i exhibits compelling synergy with MAT2Ai in efficacy model which
Slide 33: BGB-45035 (IRAK4 CDAC)
6. BGB-45035 (IRAK4 CDAC) Potent and selective degrader for various immunology and inflammation diseases • IRAK4, key downstream mediator of TLR and IL- 1R pathways, with both kinase and non-kinase Deeper degradation across various cell types scaffold functions in various Immunology and Inflammation
Slide 34: Key Late-Stage Catalysts in 2025 and 2026
Key Late-Stage Catalysts in 2025 and 2026 Asset Catalyst 1H 2025 2H 2025 2026 BRUKINSA MANGROVE TN MCL Ph3 PFS interim analysis CELESTIAL TN CLL Ph3 enrollment completion (+BRUKINSA) R/R CLL Ph3 initiation Sonrotoclax R/R MCL Ph3 initiation R/R MCL Ph2 data readout and AA submission if data
Slide 35: Key Early-Stage Catalysts in 2025 and 2026
Key Early-Stage Catalysts in 2025 and 2026 Asset Catalyst 1H 2025 2H 2025 2026 PoC Data CDK4i 2L HR+/HER2- mBC Ph3 initiation PanKRASi PoC Data B7H4 ADCa PoC Data EGFR CDAC PoC Data CDK2ib PoC Data B7H3 ADC PoC Data CEA ADC PoC Data FGFR2b ADC PoC Data IRAK4 CDAC PoC Data PRMT5i
Slide 36: Financial Results and Guidance
F I N A N C I A L R E S U LT S A N D 2 0 2 5 G U I D A N C E Aaron Rosenberg Chief Financial Officer 36 36
Slide 37: Scientific and Commercial Execution Have Driven Superior Top Line Financial Results
Scientific and Commercial Execution Have Driven Superior Top Line Financial Results Rapid product revenue growth Diversified product revenue mix and significant (US $M) growth across all markets (US $M) $3,780 % Growth +73% 35% U.S. 97% Q4 24 55% EU 149% ROWa 43% 10% $2,190 +77% $1,118 % Growt
Slide 38: Financial Results: Revenue Composition
Financial Results: Revenue Composition US $M Q4 2024 Q4 2023 % Change FY 2024 FY 2023 % Change Net Product Revenue $1,118 $631 77% $3,780 $2,190 73% BRUKINSA 828 413 100% 2,644 1,290 105% TEVIMBRA 154 128 20% 621 537 16% Amgen in-licensed 101 51 98% 365 187 95% products Other 35 39 (10%) 150 176 (15
Slide 39: Financial Results: Summary
Financial Results: Summary US $M Q4 2024 Q4 2023 % Change FY 2024 FY 2023 % Change Total Revenue $1,128 $634 78% $3,810 $2,459 55% Gross Margin $967 $529 83% $3,216 $2,079 55% Product Gross Margin % 86% 83% 84% 83% Operating Expenses (GAAP) 1,047 912 15% 3,784 3,287 15% Operating Expenses (Non-GAAP)
Slide 40: Significant Progress on Profitability and Cash Flows
Significant Progress on Profitability and Cash Flows • Three Consecutive Quarters of Non-GAAP Operating Income • Two Consecutive Quarters of Cash Flow from Operations Reduced loss from operations Generation of adjusted income Trend of improvement in cash (GAAP) (US $M) from operations1 (US $M) flow
Slide 41: Disciplined Capital Allocation Strategy
Disciplined Capital Allocation Strategy Designed to Deliver Long-Term Shareholder Returns Differentially invest in Prioritize balance sheet commercial assets strength as a sustainable and geographies that drive competitive advantage profitable growth C O N S E RVAT I V E FINANCIAL POLICIES Pursue va
Slide 42: FY2025 Guidance
FY2025 Guidance FY 2024 FY 2025 FY 2025 Actuals Guidance1 Commentary • U.S. BRUKINSA leadership expansion Total Revenue $3.8B $4.9 - $5.3B • Increasing global growth in EU/ROW • Assumes 1/31/2025 foreign exchange rates • Disciplined investment for growth with GAAP Operating Expenses meaningful opera
Slide 43: Presenters
John V. Oyler Matt Shaulis Lai Wang Aaron Rosenberg Co-Founder, General Manager, Global Head of R&D Chief Financial Officer Chairman and CEO North America BeiGene Confidential 43 43
Slide 44: }{ BeiCene > Be -
}{ BeiCene > Be -
Slide 45: Appendix
Appendix 45 45
Slide 46: Reconciliation and Calculation of Non-GAAP Financial Measurements
Reconciliation and Calculation of Non-GAAP Financial Measurements Reconciliation to adjusted (loss) income from operations (US $000’s) Twelve months ended Twelve months ended December 31, 2024 December 31, 2023 GAAP loss from operations (568,199) (1,207,736) Adjustments to GAAP loss from operations
Slide 47: Reconciliation and Calculation of Non-GAAP Financial Measurements
Reconciliation and Calculation of Non-GAAP Financial Measurements Reconciliation to adjusted (loss) income from operations (US $000’s) Three months ended Three months ended Three months ended Three months ended March 31, 2024 June 30, 2024 September 30, 2024 December 31, 2024 GAAP loss from operatio
Slide 48: Timelines of ALPINE, SEQUOIA and AMPLIFY studies
Timelines of ALPINE, SEQUOIA and AMPLIFY studies Trial 2014 2016 2018 2020 2022 2024 2026 2028 SEQUOIA November DCO Readout May Zanubrutinib +\- V 2017 2021 Dec ‘21 2026 1L CLL/SLL ALPINE November DCO Readout May Zanubrutinib 2018 2020 Mar ‘21 2024 R/R CLL AMPLIFY Readout Acalalabrutinib + V +\- O 2
Slide 49: Acronyms: A-G
Acronyms: A-G 1L 1st-line D 2L 2nd-line DLCBL Diffuse Large B-cell Lymphoma A E AA Accelerated Approval EGFRmut EGFR Mutation ADC Antibody Drug Conjugate AML Acute Myeloid Leukemia EOT End of Treatment AML/MDS Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS) EMEA Europe, the Middle Eas
Slide 50: Acronyms: H-O
Acronyms: H-O 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 51: Acronyms: P-Z
Acronyms: P-Z Q TN CLL Treatment Naïve Chronic Lymphocytic Leukemia Q1 First Quarter TN MCL Treatment Naïve Mantel Cell Lymphoma Q2 Second Quarter TsAb Trispecific Antibody Q3 Third Quarter U Q4 Fourth Quarter UBC Urinary / Bladder Cancer QD Once Daily R uMRD Undetectable Minimal Residual Disease R&