Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q2 2022 Earnings Presentation
44 slides from Burning Rock Biotech's earnings presentation, Aug 31, 2022
Slide 1: Burning Rock Biotech Limited 2Q2022 results
Burning Rock Biotech Limited 2Q2022 results BNR US Equity 31 Aug 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: Our value-building blocks
Our value-building blocks Extending leadership in NGS-based precision oncology from late-stage to earlier stage patients, opening up addressable market New Businesses Early Detection MRD1 Biopharma Asymptomatic population Early-stage oncology Global CDx2 partner for Large market potential patients p
Slide 4: Objectives by segment
Objectives by segment Continued topline growth with higher operating efficiency and reduced cash spend • 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 digi
Slide 5: Recent progress
Recent progress +3% YoY revenue growth in 2Q despite severe Covid impact, driven by in-hospital growth outside of Covid impacted regions, MRD contribution and pharma revenues • Continued execution of growth via in-hospital – severe Covid impact in Shanghai and Beijing, but other regions combined gre
Slide 6: Biopharma services
Biopharma services Rapid backlog build-up continues 1H22 pharma revenues +207% YoY (to RMB18m, contributing to 14% of overall revenues) Newly contracted pharma projects Contract value of new projects (RMB millions) 200 183 158 150 106 100 50 32 0 2020 full year 2021 full year 7M21 7M22 6
Slide 7: MRD
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Slide 8: 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 9: How do MRD studies advance utility (IMvigor010)
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 10: How do MRD studies advance utility (ctDNA-guided)
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 11: 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 11
Slide 12: 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 13: MRD clinical validation data readout (NSCLC MEDAL)
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 14: 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 14
Slide 15: Early detection
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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: 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 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: In-hospital and MRD driving growth uplift, but volumes impacted by Covid
In-hospital and MRD driving growth uplift, but patient volumes negatively impacted by Covid related restrictions Overall test volumes -1.3% YoY in 2Q • Better than peer volume performance indicates share gain 25,000 • Central-lab -1.2%, with MRD launch partially offsetting Covid impact • In-hospital
Slide 23: Latest trends
Latest trends Continued secular growth of in-hospital penetration and MRD, despite Covid disruptions Overall volume growth turned from -11% in Jun to +6% in Jul Central-lab volumes In-hospital volumes Jul +13% YoY, improved vs. 2Q’s -1%, driven by MRD Shanghai, Beijing not yet fully recovered from C
Slide 24: Financials
Financials Opex to trend down over time RMB1.15bn / USD172m cash and investments on balance as of Jun 2022 19 20 21 2Q22 2Q22 2022 RMB millions 2021 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 YoY YoY YoY YoY QoQ Guide Revenue 507.9 83% 13% 18% 106.6 127.3 126.6 147.3 135.5 130.8 3% -3% 620 Central lab 319.4 71%
Slide 25: Appendix: Early detection
Appendix 1 Early detection
Slide 26: 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. 26
Slide 27: ASCO 2022 – Thunder study read-out of the 6-cancer test
ASCO 2022 – Thunder study read-out of the 6-cancer test Cohort 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 cancer detection 28 Source: Gao et al., Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies, ASCO 2022
Slide 29: 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 29
Slide 30: The PREDICT study (NCT04817306) Study design
The PREDICT study (NCT04817306) Study design PREDICT is a prospective, multi-center, case-control, observational study for the detection of 9 cancer types through a cell-free DNA (cfDNA) methylation based, machine learning aided model 9 cancer types Squamous cell carcinoma of the head and neck Lung
Slide 31: The PREDICT study (NCT04817306)
The PREDICT study (NCT04817306) National Oncology Conference on Standardized Diagnosis and Treatment, Beijing, 14th-16th May 2021 31
Slide 32: The PRESCIENT study (NCT04822792) Study design
The PRESCIENT study (NCT04822792) Study design PRESCIENT is a prospective, multi-center, case-control, observational study aimed to train and validate the performance of a multi-omics model in the detection of 22 cancers 22 cancer types • Lung • Hematology • Stomach • Kidney • Esophagus • Uterus N=1
Slide 33: 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 34: 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 35: Appendix 2
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Slide 36: 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 36
Slide 37: 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 37
Slide 38: Appendix: Therapy selection
Appendix 3 Therapy selection
Slide 39: 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 !" Approved in Aug 2018 NMPA Gen
Slide 40: NGS testing
NGS testing Diagnostics companies focus on steps 1 and 3 Library Preparation NGS 1 EGFR ALK MET Throughput High-throughput Targeted genes enrichment Sequencing Efficiency Parallel testing Cost Low-cost per biomarker 22 Bioinformatics Analysis and Mutation Annotation Biomarker Comprehensive profiling
Slide 41: 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: 41 Slides from “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annua
Slide 42: Participating assays and study design
Participating assays and study design 42 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 43: 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 44: 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