Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q3 2021 Earnings Presentation
41 slides from Burning Rock Biotech's earnings presentation, November 2021
Slide 1: Burning Rock Biotech Limited
Burning Rock Biotech Limited BNR US Equity
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 of NGS-based precision oncology from late-stage patients to earlier stages, driving the next phase of growth New Businesses Early Detection MRD Biopharma Large market potential Asymptomatic population Early-stage oncology Global CDx partner for patients
Slide 4: Summary of recent progress
Summary of recent progress 2022 commercialization on track • Contracting completed with a small number of pilot hospitals • Focus on 1) customer education in preparation for commercial roll-out and 2) contracting additional hospitals Early detection Pipeline development progressing well • 9-cancer p
Slide 5: Pharma collaboration – our first step of global expansion
Pharma collaboration – our first step of global expansion Newly contracted pharma projects New, strong demand RMBm • New rules for CDx1 requirement from NMPA 200 • Innovative Chinese pharma going global 165 • MNCs seeking reliable global NGS CDx partners that can operate in China 150 144 Burning Roc
Slide 6: Product pipeline
Product pipeline Broad portfolio with key products demonstrating globally competitive data 2022 seeing 3 new product launches, and 9-cancer early detection data read-out Product Status Key data Multi-center case- IU population Product dev. 6-cancer early detection ESMO Asia mini-oral presentation1 A
Slide 7: Early detection
df waes Burning Rock Dx Early detection
Slide 8: Burning Rock's early detection technology
Burning Rock’s early detection technology Globally competitive technology and multi-cancer validation progress Competitive technology Methylation + machine learning to overcome challenges of low ctDNA abundance and TOO, leading to feasibility for multi-cancer early detection Multi-cancer validation
Slide 9: Product development since 2016
Product development since 2016 1 of 2 companies globally with high specificity (>98%) 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, “Ultrasensiti
Slide 10: Clinical programs on track
Clinical programs on track 9-cancer first read-out expected in 1H2022 Only company in China with 10,000-subject or larger early-detection clinical studies launched Model training Intend-to-use population Assay Proof-of-concept via large-scale validation development case-control study (Feasibility fo
Slide 11: 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 the China's largest comprehensive academic h
Slide 12: Leadership in multi-cancer early detection
Leadership in multi-cancer early detection First-in-class, high entry-barrier, multi-year effort Challenge 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 Technolo
Slide 13: MRD
df waes Burning Rock Dx MRD
Slide 14: Clinical utilities of MRD in solid tumors
Clinical utilities of MRD in solid tumors 1) Risk stratification post resection (adjuvant therapy), 2) relapse monitoring, 3) therapy response monitoring 14
Slide 15: MRD product pipelines
MRD product pipelines Tumor-agnostic and tumor-informed products under parallel development Assay and Model Analytical Clinical Validation Product Launch Development Validation (Prognosis and Surveillance) Lung read-out: 1H2022, Completed Colon / Esophageal / Tumor-informed Personalized assay: brPRO
Slide 16: Financials
df waes Burning Rock Dx Financials
Slide 17: Travel restrictions impacting volumes due to 'zero-case' approach in China
Travel restrictions impacting volumes due to ‘zero-case’ approach in China August saw significant impact from a delta-variant resurgence Currently in the middle of another wave as of 16th November Number of cities affected1 Examples of Covid impact • School closures in Beijing, Shanghai; suspension
Slide 18: Accelerated transition towards in-hospital during 2021
Accelerated transition towards in-hospital during 2021 Industry-leading overall volume growth, +38% during 9M21 In-hospital volume contribution reaching above 50% since 2Q21 YoY -10% +25% +33% +13% +86% +40% +14% 20,000 15,000 Therapy selection 10,000 volumes1 5,000 0 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3
Slide 19: In-hospital segment
In-hospital segment Dominant market share, industry-leading growth rate Resilient volumes in 3Q despite Covid impact YoY -8% +31% +39% +20% +112% +70% +37% 15,000 Number of testing kits 10,000 shipped to partner hospitals1 5,000 0 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 58 52 40 24 23 Number of 26 21 par
Slide 20: Central-lab segment
Central-lab segment Subject to Covid fluctuations and LDT regulatory uncertainty in China 2018 2019 2020 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 # of ordering hospitals 263 335 312 232 284 289 294 303 300 287 # of ordering physicians 1,135 1,632 1,318 810 1,175 1,194 1,114 1,082 1,013 920 Central- lab vo
Slide 21: Financials
Financials Strong volume growth (+38% in 9M21) but transient impact on blended ASP during transition to in-hospital 3Q21 impacted by Covid surge in August 18 19 20 3Q21 3Q21 2021 RMB millions 2019 2020 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 YoY YoY YoY YoY QoQ Guide Around Revenue 381.7 429.9 88% 83% 13
Slide 22: Summary outlook and catalysts
Summary outlook and catalysts Growth driver Catalyst Metrics Near-term • Therapy selection volume growth through in- • IVD kit volume hospital taking share, out-growing industry • New hospital add backlog • Early detection commercialization in 2022 • Product revenues Medium-term • MRD launch in 2022
Slide 23: Appendix: Early detection
Appendix 1 Early detection
Slide 24: ESMO Asia mini-oral presentation, Nov 2020
ESMO Asia mini-oral presentation, Nov 2020 Overview of training and validation sets Training Control Cancer LC CRC LIHC OVCA PAAD ESCA total 195 274 50 46 48 50 40 40 age, mean+/-SD 53+/-6 57+/-8 60+/-6 60+/-8 55+/-8 50+/-8 59+/-7 57+/-6 age, min/max 40/72 40/75 47/74 44/75 43/72 40/73 42/71 45/70 s
Slide 25: Sensitivity
ESMO Asia mini-oral presentation, Nov 2020 Our test detects cancers at an early stage with high specificity and high sensitivity Sensitivity Clinical Stages（# in Training / # in Validation） • The specificity was 99.5% (95%CI: 96.7-100%; training) and 98.3% (95%CI: 95.8-99.4%; validation) • The sensi
Slide 26: ESMO Asia mini-oral presentation, Nov 2020
ESMO Asia mini-oral presentation, Nov 2020 Our test detects cancers at an early stage with high specificity and high sensitivity Training Validation Training Validation 26 Source: Qiang Gao et al., LBA3 Early detection and localization of multiple cancers using a blood-based methylation assay (Elsa-
Slide 27: ESMO Asia mini-oral presentation, Nov 2020
ESMO Asia mini-oral presentation, Nov 2020 Our test predicts the tissue of origin with high accuracy • The classifier was able to distinguish different cancer tissue samples with exceptional accuracy (129/131). • 98.6% of detected cancer blood samples were assigned an organ-source in both training a
Slide 28: ESMO Asia mini-oral presentation, Nov 2020
ESMO Asia mini-oral presentation, Nov 2020 6-cancer test sensitivity by cancer type and stage Sensitivity and Specificity - Correct#/Total# (%) Cancer Group I II III IV Overall Train 10/20 (50.0) 10/14 (71.4) 4/7 (57.1) 8/9 (88.9) 32/50 (64.0) Lung Test 6/16 (37.5) 12/16 (75.0) 9/14 (64.3) 14/15 (93
Slide 29: 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 30: The PREDICT study (NCT04817306) Objectives and timeline
The PREDICT study (NCT04817306) Objectives and timeline Objectives Primary objective: • To train and validate the sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model for early detection of 9 types of cancers Key secondary objectives: • To evaluate the sensitivity, specificit
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: The PRESCIENT study (NCT04822792) Objectives and timeline
The PRESCIENT study (NCT04822792) Objectives and timeline Objectives Primary objective • To train and validate the sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model combined with tumor protein markers for early detection of 22 types of cancers Secondary objective • To eval
Slide 34: 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 35: 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 36: Appendix: Therapy selection
Appendix 2 Therapy selection
Slide 37: 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 38: 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: 38 Slides from “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annua
Slide 39: Participating assays and study design
Participating assays and study design 39 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 40: 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 41: 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