Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q3 2022 Earnings Presentation
40 slides from Burning Rock Biotech's earnings presentation, Nov 16, 2022
Slide 1: Burning Rock Biotech Limited 3Q2022 results
Burning Rock Biotech Limited 3Q2022 results Nasdaq and LSE: BNR 16 Nov 2022
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Burning Rock Biotech Limited (the “Company”) solely for information purpose and has not been independently verified. No representations, warranties or undertakings, express or implied, are made by the Company or any of its affiliates, advisers, or re
Slide 3: Recent progress
Recent progress Listed on London Stock Exchange on 1 Nov, providing an alternative listing venue +22% YoY revenue growth in 3Q, out-growing industry again • Continued market share gain via in-hospital (in-hospital volumes +24% YoY in 3Q, strong bounce-back from 2Q, +36% QoQ) Therapy selection • Opex
Slide 4: Our value-building blocks
Our value-building blocks Extending leadership in NGS-based precision oncology from late-stage to earlier stage patients, increasing the size of the addressable market New Businesses Early Detection MRD1 Biopharma Asymptomatic population Early-stage oncology Global CDx2 partner for Large market pote
Slide 5: Objectives by segment
Objectives by segment Continued topline growth with higher operating efficiency and improving cash flow • Positive operating profitability in 2023 Therapy selection Through accelerated transition towards the profitable in-hospital channel and reduced opex in central-lab • Multi-year, high double-dig
Slide 6: MRD
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Slide 7: MRD test plays a role at multiple timepoints throughout the treatment journey
MRD test plays a role at multiple timepoints throughout the treatment journey Resectable Neo- Surgical Adjuvant Relapse Tumor adjuvant Resection The baseline Treatment Landmark MRD Treatment Longitudinal ctDNA level effectiveness effectiveness monitoring assessment assessment Good vs. poor Whether a
Slide 8: How do MRD studies advance utility
How do MRD studies advance utility Example 1: IMvigor010, enrich the high-risk group and "tune-up" adjuvant treatment Atezo, MIUC Adjuvant Therapy “All comers” demonstrated NO efficacy TMB/PD-L1 showed NO prediction Indeed, only baseline MRD+ pts showed benefit Landmark MRD+ pts (39%) had worse prog
Slide 9: How do MRD studies advance utility: Example 2
How do MRD studies advance utility Example 2: Dynamic, identify low-risk patients and “tune-down” adjuvant treatment ctDNA-guided vs standard The ctDNA-guided MRD- group had fewer patients with adjuvant chemotherapy than the standard group (15% vs. 29%) with non-inferiority of 3-year RFS (92.4% vs 9
Slide 10: MRD clinical adoption through physician consensus
MRD clinical adoption through physician consensus Chinese oncologists developing consensus on MRD applications in solid tumors, e.g. lung cancer 10
Slide 11: Burning Rock development plans
Burning Rock development plans Personalized approach (brPROPHETTM) demonstrating strong analytical performance Additional clinical studies to expand indications Assay and Model Analytical Clinical Validation Product Launch Development Validation (Prognosis and Surveillance) Product Completed Commerc
Slide 12: MRD clinical validation data readout NSCLC – MEDAL study
MRD clinical validation data readout NSCLC – MEDAL study • brPROPHET identified 2.7 times more true high-risk patients than the fixed panel approach at the landmark time point • Longitudinally MRD negative patients has near-perfect prognosis with median of 3-year follow-up • The prognosis differenti
Slide 13: MRD clinical validation data readout CRC
MRD clinical validation data readout CRC brPROPHETTM demonstrated superior sensitivity and specificity to fixed panel in pre-operative ctDNA detection and post-operative MRD calling among relapsed patients 13
Slide 14: Early detection
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Slide 15: Burning Rock's early detection technology
Burning Rock’s early detection technology Globally competitive technology with multi-cancer validation Competitive technology Methylation + machine learning to overcome challenges of low ctDNA abundance, leading to feasibility of multi-cancer early detection AACR 2022 Multi-cancer validation data AS
Slide 16: Product development since 2016
Product development since 2016 Demonstrated high specificity and tissue-of-origin detection capability • Proof of concept on our methylation based, machine learning aided technology platform Proof-of-concept • Results published on Nature Biomedical Engineering, “Ultrasensitive detection of circulati
Slide 17: Clinical programs
Clinical programs 9-cancer development first read-out in Sep (PROMISE study) China’s first interventional study for multi-cancer launched in 2Q (PREVENT study) Model training Assay Intend-to-use Proof-of-concept via large-scale development population validation case-control study Completed Completed
Slide 18: PROMISE study read-out at ESMO
PROMISE study read-out at ESMO 9-cancer test showing significant performance improvement over the 6-cancer test Accuracy of Cancer (n) Non-cancer (n) Specificity (%) Sensitivity (%) top predicted origin (%) Training 470 511 97.9% (96.1%-99.0%) 81.7% (78.1%-84.9%) 86.6% (83.0%-90.0%) Validation 257 2
Slide 19: Leadership in multi-cancer early detection
Leadership in multi-cancer early detection First-in-class, high entry-barrier, multi-year effort Challenges BNR position 1 Low amount of cancer signal Proprietary chemistry and algorithm in the circulating bloodstream, much more • On par with global leader, competitive sensitivity in earlier Technol
Slide 20: Leadership from top-tier principal investigators key to clinical success
Leadership from top-tier principal investigators key to clinical success Also drives increasing recognition on multi-cancer early detection among clinicians PREDICT Principal Investigator: Prof. Jia Fan • Leading site: Shanghai Zhongshan Hospital − One of China's largest comprehensive academic hospi
Slide 21: Financials
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Slide 22: Quarterly volumes
Quarterly volumes In-hospital and MRD driving above-industry growth uplift Overall test volumes +16% YoY in 3Q 25,000 • Central-lab +2.3% YoY, driven by MRD • In-hospital +24% YoY, rebounding from 2Q (+36% QoQ) 20,000 15,000 Volumes by channel1 10,000 5,000 0 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 4Q20
Slide 23: Financials
Financials Opex starting to trend down RMB1.01bn / USD143m cash and investments on balance as of September 30, 2022 19 20 21 3Q22 3Q22 2022 Revised RMB millions 2021 3Q21 4Q21 1Q22 2Q22 3Q22 YoY YoY YoY YoY QoQ Guide Revenue 507.9 83% 13% 18% 126.6 147.3 135.5 130.8 154.6 22% 18% c. 5% YoY growth Ce
Slide 24: Appendix 1: Early detection
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Slide 25: AACR 2022
AACR 2022 Data read-out on analytical performance of ELSA-seq Full analytical validation study was conducted on ELSA-seq. LoD was demonstrated to be between 0.02% and 0.11% across different cancer types. 25
Slide 26: ASCO 2022 – Thunder study read-out of the 6-cancer test
ASCO 2022 – Thunder study read-out of the 6-cancer test Cohort 26 Source: Gao et al., Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies, ASCO 2022
Slide 27: ASCO 2022 – Thunder study read-out of the 6-cancer test
ASCO 2022 – Thunder study read-out of the 6-cancer test Clinical performance on cancer detection 27 Source: Gao et al., Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies, ASCO 2022
Slide 28: ASCO 2022 – Thunder study read-out of the 6-cancer test
ASCO 2022 – Thunder study read-out of the 6-cancer test Clinical performance on tissue of origin Source: Gao et al., Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies, ASCO 2022 28
Slide 29: Multi vs. single cancer early detection
Multi vs. single cancer early detection Multiple times larger TAM China Cancer Incidence1 per 100,000 population, across all ages All cancer types 288 BR-22 254 BR-9 184 BR-6 144 Lung Breast Gastric Liver 28 Colorectal 28 Esophagus Cervix Thyroid Prostate Uterus 0 50 100 150 200 250 300 350 BR-22 co
Slide 30: Multi vs. single cancer early detection in China
Multi vs. single cancer early detection in China Significantly higher technology barrier • Established technology, typically PCR based, with readily available products o US – First FDA approved product in 2014 (first submission in 2012) Single-cancer o China – NMPA approved products (class-III, incl
Slide 31: Appendix 2: MRD
Appendix 2 MRD
Slide 32: Clinical utilities of MRD in solid tumors
Clinical utilities of MRD in solid tumors 1) risk stratification and regimen selection (landmark analysis), 2) relapse monitoring (surveillance analysis) Cancer Discov. 2021 Nov 16. doi: 10.1158/2159-8290.CD-21-0634 32
Slide 33: Clinical utilities of MRD in solid tumors
Clinical utilities of MRD in solid tumors Fixed panel vs. personalized panel approaches Cancer Discov. 2021 Nov 16. doi: 10.1158/2159-8290.CD-21-0634 33
Slide 34: Appendix 3: Therapy selection
Appendix 3 Therapy selection
Slide 35: NMPA approved NGS panels
NMPA approved NGS panels First NMPA-approved kit Second NMPA-approved kit EGFR, ALK, BRAF, KRAS EGFR, KRAS, MET, ERBB2, BRAF, PIK3CA, Approved in Jul 2018 ALK, ROS1, RET First approved NGS kit in China Approved in Mar 2022 Novogene EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 诺禾 Approved in Aug 2018 NMPA Gen
Slide 36: NGS testing
NGS testing Diagnostics companies focus on steps 1 and 3 Library Preparation NGS EGFR ALK MET Throughput High-throughput 1 Targeted genes enrichment Sequencing Efficiency Parallel testing Cost Low-cost per biomarker 22 Bioinformatics Analysis and Mutation Annotation Biomarker Comprehensive profiling
Slide 37: Leading liquid-biopsy product in China, with globally competitive performance
Leading liquid-biopsy product in China, with globally competitive performance Demonstrated in high-impact analytical validation study SEQC2 Study Overview Liquid Biopsy Source: 37 Slides from “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annua
Slide 38: Participating assays and study design
Participating assays and study design 38 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 39: Overall analytical accuracy and specificity
Overall analytical accuracy and specificity • The analytical accuracy was measured by Precision- Sensitivity plot (25ng LBx-Low) • The false positive rates were computed by FP/kb region. • Once different VAF threshold increases, FP rates dropped further. “To compare the accuracy of the participating
Slide 40: Performance – Sensitivity
Performance – Sensitivity “The most sensitive assays (IDT and BRP) achieved sensitivity greater than 0.90 for variants with 0.3–0.5% VAF; however, no assays reached this mark for variants with 0.2–0.3% or 0.1– 0.2% VAF (Fig. 4a).” “The performance characteristics of the assays evaluated here were br