Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q4 2020 Earnings Presentation
29 slides from Burning Rock Biotech's earnings presentation, 2021
Slide 1: Burning Rock Biotech Limited 4Q20 Updates
Burning Rock Biotech Limited 4Q20 Updates 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: 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: Today's topics
Today’s topics • 2020 recap • Blood-based multi-cancer early detection – from lab to commercialization • Liquid biopsy therapy selection testing – strengthening our position for long-term success • 2021 priorities • Financials 4
Slide 5: 2020 recap
2020 recap Leader in China’s NGS-based precision oncology diagnostics market • 273k cumulative tests completed. 72k tests completed in-hospital1 Therapy • +33% YoY revenue growth in 2H20, +43% gross profit growth Selection o +26% central-lab revenue in 2H20. 44% tests were blood-based during 2020 o
Slide 6: Today's topics
Today’s topics • 2020 recap • Blood-based multi-cancer early detection – from lab to commercialization • Liquid biopsy therapy selection testing – strengthening our position for long-term success • 2021 priorities • Financials 6
Slide 7: Bringing multi-cancer early detection from lab to the real world
Bringing multi-cancer early detection from lab to the real world 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
Slide 8: Path to commercialization
Path to commercialization Positive feedback from commercial insurers and hospitals Commercial insurers Hospitals Commercial Payor market with commercial insurers High-end self-pay market with top channels comprehensive hospitals, leveraging existing commercial relationships built as part of the ther
Slide 9: Product development roadmap
Product development roadmap Multi-year effort, high entry barriers. Real-world use provides feedback loop for product development • Results released at AACR 2019 Single-cancer • Lung cancer, proof of concept on assay and bioinformatics methodology 2016 – 2019 • Manuscript on methodology under peer r
Slide 10: Multi vs. single cancer early detection in China
Multi vs. single cancer early detection in China Multiple times larger TAM China Urban Cancer Incidence1 per 100,000 population, across all ages All cancer types 311 BR-9 189 BR-6 153 Lung Breast Colorectal 34 Gastric Liver 26 Thyroid Cervix Esophagus Brain Pancreas Ovary 0 50 100 150 200 250 300 35
Slide 11: 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 12: Today's topics
Today’s topics • 2020 recap • Blood-based multi-cancer early detection – from lab to commercialization • Liquid biopsy therapy selection testing – strengthening our position for long-term success • 2021 priorities • Financials 12
Slide 13: Factors for long-term success
Factors for long-term success Product as the core factor. 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 whose products h
Slide 14: FDA-led SEQC2 consortium study
FDA-led SEQC2 (sequencing quality control) consortium study SEQC2 Study Overview Liquid Biopsy Section Source: 14 “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annual Liquid Biopsy for Precision Oncology Summit, Feb 2021
Slide 15: Liquid biopsy results
Liquid biopsy results Full results pending publication of manuscript, which has been accepted by Nature Biotech 15 Source: “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annual Liquid Biopsy for Precision Oncology Summit, Feb 2021
Slide 16: Liquid biopsy NMPA progress update
Liquid biopsy NMPA progress update BR OncoCompass Target in leading position for multi-gene ctDNA NMPA approval process NMPA1 diagnostics approval process overview Analytical Typing Clinical Validation Review & • Concordance study Validation Test • CDx collaborations Approval BR’s OncoCompassTM ü 10
Slide 17: Today's topics
Today’s topics • 2020 recap • Blood-based multi-cancer early detection – from lab to commercialization • Liquid biopsy therapy selection testing – strengthening our position for long-term success • 2021 priorities • Financials 17
Slide 18: 2021 priorities
2021 priorities Driving increased penetration of NGS-based diagnostics through product and commercial strengths • Expansion of product menu Therapy o Completing tech transfer and validation of in-licensed products (myChoice HRD testing1, DetermaRx2) Selection o Additional products under R&D • NMPA r
Slide 19: Today's topics
Today’s topics • 2020 recap • Blood-based multi-cancer early detection – from lab to commercialization • Liquid biopsy therapy selection testing – strengthening our position for long-term success • 2021 priorities • Financials 19
Slide 20: Operating metrics
Operating metrics 2018 2019 2020 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 4Q20 # of ordering hospitals 263 335 312 249 265 281 304 232 284 289 294 # of ordering physicians 1,135 1,632 1,318 984 1,059 1,155 1,222 810 1,175 1,194 1,114 Central- lab # of patients tested1 15,821 23,075 25,262 5,336 6,047 6,76
Slide 21: Financials
Financials 18 19 20 2H20 4Q20 4Q20 2021 RMB millions 2019 2020 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 4Q20 YoY YoY YoY YoY YoY QoQ Guide Revenue 381.7 429.9 88% 83% 13% 104.5 84.8 103.7 88.7 67.3 107.0 123.9 131.7 33% 49% 6% 610 Central lab 276.3 297.3 83% 71% 8% 72.8 63.4 69.3 70.8 46.1 74.6 89.9 86.7
Slide 22: Appendix: 6-Cancer early detection performance
Appendix 6-Cancer early detection performance data released at ESMO Asia (Nov 2020)
Slide 23: 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 24: Clinical progress
Clinical progress Marker discovery ~5.5 million CpG sites ~450,000 CpG sites (tissue) LC/CRC/LIHC/OVCA/PAAD/ESCA TCGA & GEO database Panel validation ~160,000 CpG sites (tissue and blood) LC/CRC/LIHC/OVCA/PAAD/ESCA/Control Training Set Validation Set Additional Validation Assay validation (blood) LC
Slide 25: Overview of training and validation sets
Overview of training and validation sets Comparable cancer and non-cancer groups 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 sex,
Slide 26: Sensitivity
Our test detects cancers at 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 sensitivity was 79.9% (95%CI: 74.6-84.4%; training)
Slide 27: Our test detects cancers at early stage with high specificity and sensitivity
Our test detects cancers at early stage with high specificity and high sensitivity Training Validation Training Validation 27
Slide 28: Our test predicts the tissue of origin with high accuracy
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 and validation sets: o For single organ call
Slide 29: 6-cancer test sensitivity by cancer type and stage
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 (93.3) 41/61 (67.2) Train 7/9 (77.8) 12/12 (10