Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q4 2021 Earnings Presentation
44 slides from Burning Rock Biotech's earnings presentation, Mar 22, 2022
Slide 1: Burning Rock Biotech Limited 4Q2021 results presentation
Burning Rock Biotech Limited 4Q2021 results presentation BNR US Equity 22 Mar 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 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: Recap of 2021 and recent progress
Recap of 2021 and recent progress • Achieved 38% volume growth year-on-year, reaching 70k+ units (central-lab and in-hospital combined) during 2021, out-growing industry Therapy selection • Strong market share gain through in-hospital strategy; in-hospital volume growth of 63% in 2021 • 18% revenues
Slide 5: 2022 outlook
2022 outlook • New product launches to expand into additional indications1 • Continued drive towards in-hospital testing, with accelerating number of newly contracted Therapy selection hospitals, and volume ramp of existing hospitals • Accelerated revenue growth vs. 2021 (initial 2022 revenue guidan
Slide 6: 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 7: Early detection
df waes Burning Rock Dx Early detection
Slide 8: Product development since 2016
Product development since 2016 Demonstrated 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, “Ultrasensitive detection of ci
Slide 9: Clinical programs
Clinical programs 9-cancer first read-out expected in 2022 Model training Assay Intend-to-use Proof-of-concept via large-scale development population validation case-control study Completed PREVENT study 6-cancer Completed c.10,000 participants THUNDER study1 Launching in 2022 PROMISE study PREDICT
Slide 10: 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 and TOO, leading to feasibility for multi- cancer early detection Multi-cancer validation data 10
Slide 11: Data read-out on analytical performance of ELSA-seq
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. 11
Slide 12: 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 13: 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 14: MRD
df waes Burning Rock Dx MRD
Slide 15: 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 15
Slide 16: 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) Chinese oncologists developing consensus on MRD IMvigor010 – MRD demonstrating CDx potential applications in solid tumors, e.g. lung cancer Nature
Slide 17: 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 17
Slide 18: MRD product pipelines
MRD product pipelines Personalized approach (brPROPHETTM) demonstrating stronger performance, esp. in early stage patients Assay and Model Analytical Clinical Validation Product Launch Development Validation (Prognosis and Surveillance) Lung and colon read-out: Completed 2022 AACR Launch in Tumor-in
Slide 19: MRD clinical validation data readout
MRD clinical validation data readout NSCLC In the full MEDAL cohort, MRD- patients assessed by brPROPHET achieved a 12-month 19 recurrence-free rate > 95% (unpublished data) ™
Slide 20: MRD clinical validation data readout
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 20
Slide 21: Financials
df waes Burning Rock Dx Financials
Slide 22: Latest Covid impact
Latest Covid impact Omicron wave spreading in China; much larger impact due to higher transmissions Worst wave of outbreaks observed since the nation-wide lockdown in 2020 • Shanghai school closures, semi-lockdown (Mar 2022) • Shenzhen lockdown (Mar 2022) • Changchun lockdown (Mar 2022) • Jilin prov
Slide 23: Continued in-hospital strength and improved central-lab driving growth uplift
Continued in-hospital strength and improved central-lab driving growth uplift 4Q21 growth turned better than 3Q21, Jan-Feb 2022 (pre Covid lockdowns in Mar) even better than 4Q21 Central-lab volume growth turned positive in 4Q21, and grew better Jan-Feb 2022, on the back of new products YoY +10% 202
Slide 24: In-hospital segment
In-hospital segment Accelerated rate of penetrating into additional hospitals during 2021 YoY -8% +31% +39% +20% +112% +70% +37% +62% 15,000 Number of testing kits 10,000 shipped to partner hospitals1 5,000 0 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q21 64 52 23 40 23 Number of 26 21 partner 16 14 41 +12
Slide 25: Financials
Financials 19 20 21 4Q21 4Q21 2022 RMB millions 2020 2021 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q21 YoY YoY YoY YoY QoQ Guide Revenue 429.9 507.9 83% 13% 18% 67.3 107.0 123.9 131.7 106.6 127.3 126.6 147.3 12% 16% 620 Central lab 297.3 319.4 71% 8% 7% 46.1 74.6 89.9 86.7 74.6 80.0 78.8 86.0 -1% 9% In-h
Slide 26: Appendix: Early detection
Appendix 1 Early detection
Slide 27: 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 28: 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 29: 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 29 Source: Qiang Gao et al., LBA3 Early detection and localization of multiple cancers using a blood-based methylation assay (Elsa-
Slide 30: 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 31: 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 32: 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 33: 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 34: The PREDICT study (NCT04817306)
The PREDICT study (NCT04817306) National Oncology Conference on Standardized Diagnosis and Treatment, Beijing, 14th-16th May 2021 34
Slide 35: 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 36: 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 37: 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 38: 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 39: Appendix: Therapy selection
Appendix 2 Therapy selection
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