Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q1 2021 Earnings Presentation
35 slides from Burning Rock Biotech's earnings presentation, May 2021
Slide 1: Burning Rock Biotech Limited
Burning Rock Biotech Limited BNR US Equity MSCI China index constituent since May 2021
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: What we do: China's molecular diagnostics leader for precision oncology
What we do China’s molecular diagnostics leader for precision oncology Early Detection $29bn TAM Therapy Selection & MRD $4.5bn TAM Notes: 3 Total addressable market size estimated per China Insights Consultancy industry report
Slide 4: Recap of recent progress
Recap of recent progress Early Detection • PRESCIENT study launched for the development of our multi-omics 22-cancer test • Ongoing progress with PREDICT study, for the development of our 9-cancer test • Ongoing preparation work for commercialization of our 6-cancer test Therapy Selection • Full res
Slide 5: Early detection
df waes Burning Rock Dx Early detection
Slide 6: Product development roadmap
Product development roadmap Multi-year effort, high entry barriers Proof-of-concept • Proof of concept on our methylation based, machine learning aided technology platform 2016 – 2019 • Results released at AACR 2019 (lung cancer). Manuscript pending publication • Lung, Colorectal Cancer (CRC), Hepat
Slide 7: Clinical programs
Clinical programs Large-cohort, high-quality clinical execution: key to product development and model training Assay Analytical Case-control Asymptomatic Development Validation Study Validation Study 3-cancer Completed Completed 6-cancer Completed Under planning THUNDER study1 Enrolment ongoing 9-ca
Slide 8: The PREDICT study: 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 9: The PREDICT study: 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 10: The PREDICT study
The PREDICT study (NCT04817306) National Oncology Conference on Standardized Diagnosis and Treatment, Beijing, 14th-16th May 2021 10
Slide 11: The PRESCIENT study: 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 12: The PRESCIENT study: 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 13: Leadership from top-tier principal investigators key to clinical success
Leadership from top-tier principal investigators key to clinical success PREDICT • Leading site: Shanghai Zhongshan Hospital − One of the China's largest comprehensive academic hospitals Principal Investigator: Prof. Jia Fan − Performs c.104,000 operations and serves c.169,000 inpatients and over 4,
Slide 14: Therapy selection testing
df waes Burning Rock Dx Therapy selection testing
Slide 15: Factors for long-term success
Factors for long-term success Strong product performance as the core. NMPA approvals enable competitive differentiation Superior products Strong performance in head-to-head comparisons among global peers NMPA approvals Leading position in NGS-based, multi-gene, ctDNA panel, one of few companies whos
Slide 16: FDA-led SEQC2 study overview
FDA-led SEQC2 study overview SEQC2 Study Overview Liquid Biopsy Source: 16 “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annual Liquid Biopsy for Precision Oncology Summit, Feb 2021
Slide 17: Participating assays and study design
Participating assays and study design 17 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 18: Performance - Molecular recovery capability and coverage uniformity
Performance - Molecular recovery capability and coverage uniformity “We evaluated coverage depth, which is considered a key variable in ctDNA sequencing. We observed substantial differences in coverage among different assays, with median unique fragment depth ranging from ~4,700-fold (BRP and ROC) t
Slide 19: 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
Slide 20: Performance - Reproducibility
Performance - Reproducibility • The reproducibility reduced in lower VAF bin (0.1-0.5%) • Cross-lab and Within-Lab reproducibility performance is mainly driven by VAF 20 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnolo
Slide 21: Performance – Robustness for low-input cfDNA samples
Performance – Robustness for low-input cfDNA samples “The increasing fragment-depth afforded by 25 ng input, compared to 10 ng, resulted in substantial improvements in sensitivity, reproducibility and overall diagnostic performance for all assays, particularly for low-frequency variants (Fig. 5b-e;
Slide 22: 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 23: Financials
df waes Burning Rock Dx Financials
Slide 24: Operating metrics
Operating metrics 2018 2019 2020 1Q19 1Q20 2Q20 3Q20 4Q20 1Q21 # of ordering hospitals 263 335 312 249 232 284 289 294 303 # of ordering physicians 1,135 1,632 1,318 984 810 1,175 1,194 1,114 1,082 Central- lab # of patients tested1 15,821 23,075 25,262 5,336 4,680 7,252 8,644 7,989 7,716 channel Yo
Slide 25: Financials
Financials 18 19 20 1Q21 1Q21 2021 RMB millions 2019 2020 1Q20 2Q20 3Q20 4Q20 1Q21 YoY YoY YoY YoY QoQ Guide Revenue 381.7 429.9 88% 83% 13% 67.3 107.0 123.9 131.7 106.6 58% (19%) 610 Central lab 276.3 297.3 83% 71% 8% 46.1 74.6 89.9 86.7 74.6 62% (14%) In-hospital 87.7 117.9 209% 164% 34% 17.1 27.6
Slide 26: Appendix: Early detection
Appendix 1 Early detection
Slide 27: Burning Rock early detection technology – ELSA-seq
Burning Rock early detection technology – ELSA-seq R&D started in 2016; combination of targeted deep methylation sequencing and machine learning Technology Highlights: ü Single-stranded library prep starts as low as 1ng cfDNA ü Bisulfite conversion or enzymatic conversion compatible ü Intelligent pr
Slide 28: 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 29: 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 30: 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 30 Source: Qiang Gao et al., LBA3 Early detection and localization of multiple cancers using a blood-based methylation assay (Elsa-
Slide 31: 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 32: 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 33: 6-cancer test
6-cancer test Product development completed, early access initiated Product development Intended-use validation Commercial roll-out ü Training and case- Ø Early access in progress • Revenue generation controlled validation targeted for 2022, BR (completed) Ø Prospective validation subject to early-a
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