Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q2 2023 Earnings Presentation
43 slides from Burning Rock Biotech's earnings presentation, Aug 31, 2023
Slide 1: Burning Rock Biotech Limited 2Q2023 results
Burning Rock Biotech Limited 2Q2023 results Nasdaq and LSE: BNR 31 Aug 2023
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 New Businesses Early Detection MRD1 Biopharma Asymptomatic population Early-stage oncology Global CDx2 partners for Large market potential patients pivotal trials of targeted At e
Slide 4: 2023 goals and outlook
2023 goals and outlook Goal #1, profitability • Achieve adjusted profitability breakeven excluding R&D during a 2023 quarter (defined as Non-GAAP gross profit minus SG&A expenses*) Goal #2, profitable growth Corporate • 20% year-over-year revenue growth for 2023 Goal #3, further our lead in multi-ca
Slide 5: 2Q2023 marks the first quarter of breakeven in our operating history
2Q2023 marks the first quarter of breakeven in our operating history Breakeven defined as Non-GAAP gross profit minus SG&A* Non-GAAP gross profit minus SG&A* (RMB millions) 7.6 (3.8) (16.0) (36.8) (53.1) (84.2) 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 Notes: * Non-GAAP gross profit, which is defined as gross p
Slide 6: 2Q2023 progress
2Q2023 progress • Execution towards profitability well underway. Corporate Non-GAAP gross profit* exceeded SG&A expenses* in 2Q23 • Continued strength in in-hospital channel Therapy selection • Sales efficiency continues to improve. Non-GAAP selling expenses* as % of revenues dropped to 44% in 2Q23,
Slide 7: Quarterly volumes
Quarterly volumes 30,000 Overall test volumes +19% vs 1Q23 • Central-lab +7% QoQ • In-hospital +24% QoQ 25,000 20,000 15,000 Volumes by channel1 10,000 5,000 0 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 Central-lab In-hospital Notes: 7 1 Central-lab (LDT) volumes represent
Slide 8: Financials
Financials 19 20 21 22 2Q23 2Q23 RMB millions 2021 2022 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 YoY YoY YoY YoY YoY QoQ Revenue 507.9 563.1 83% 13% 18% 11% 135.5 130.8 154.6 142.2 142.6 146.2 12% 3% Central lab 319.4 314.8 71% 8% 7% -1% 74.2 78.6 90.0 72.0 61.8 66.2 -16% 7% In-hospital1 165.1 175.3 164% 34% 4
Slide 9: Cash position
Cash position 3 years runway based on existing cash balance Sufficient cash to fund early detection product development and all existing clinical studies RMBm 2022 1H2023 2023E1 2024E1 Operating cash outflow2 457 192 Capex3 75 7 Sum 532 199 c.400 c.200 Cash balance at period-end4 925 733 Estimate as
Slide 10: Early detection
Ps elisa Burning Rock Dx Early detection
Slide 11: Burning Rock's early detection technology
Burning Rock’s early detection technology Competitive technology Methylation + machine learning to overcome challenges of low ctDNA abundance Multi-cancer validation data AACR 2022 ESMO 2022 Regulatory breakthrough device designation granted breakthrough 11
Slide 12: Product development roadmap
Product development roadmap • Proof of concept on our methylation based, machine learning aided technology platform Proof-of-concept • Results published on Nature Biomedical Engineering, “Ultrasensitive detection of circulating tumour DNA 2016 – 2019 via deep methylation sequencing aided by machine
Slide 13: Clinical programs
Clinical programs One of the largest datasets globally, prospectively enrolled, across large number of cancer types / stages Assay Marker discovery, Intend-to-use development model training validation THUNDER study PREVENT study ELSA-seqTM 2,395 participants (12,500 participants) 6-cancer Completed
Slide 14: Running the largest clinical programs in China supported by top physicians
Running the largest clinical programs in China supported by top physicians PREDICT Principal Investigator: Prof. Jia Fan • Leading site: Shanghai Zhongshan Hospital − One of China's largest comprehensive academic hospitals − Performs c.104,000 operations and serves c.169,000 inpatients and over 4,23
Slide 15: Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD)
Slide 16: 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 17: brPROPHET – Burning Rock's MRD solution
brPROPHETTM – Burning Rock’s MRD solution PROPHET Patient-specific pROgnostic and Potential tHErapeutic marker Tracking Whole Exome Sequencing Tumor Profiling with add-on region for SV detection SNV/SV/CNV/MSI/HLA/Therapy Selection Personalized Panel Intelligent selection of 50 tracking sites brPROP
Slide 18: Burning Rock's MRD clinical publications
Burning Rock’s MRD clinical publications Covers adjuvant and relapse settings in lung, colorectal and pancreatic cancers Resectable Neo- Surgical Adjuvant Relapse Tumor adjuvant Resection The baseline Treatment Landmark MRD Treatment Longitudinal ctDNA level effectiveness effectiveness monitoring as
Slide 19: Individualized tumor-informed ctDNA analysis for NSCLC – the MEDAL study
Individualized tumor-informed ctDNA analysis for postoperative monitoring of non-small cell lung cancer (NSCLC) – the MEDAL study Personalized assay significantly out- Post-operative prognostic at landmark Longitudinal analysis with follow-up performs fixed panels timepoint timepoints 3a Sensitivity
Slide 20: Gastric cancer cohort publication at AACR 2023
Gastric cancer cohort publication at AACR 2023 Study cohort Personalized assay significantly out-performs Postoperative prognosis fixed panels The ctDNA+ rate of preoperative samples detected by fixed panel and personalized brPROPHETTM assays 20 Source: Xue et al., Circulating tumor DNA based molecu
Slide 21: Appendix 1: Early detection
Burning Rock Dx Appendix 1 Early detection
Slide 22: Product Development Roadmap
Product Development Roadmap • Proof of concept on our methylation based, machine learning aided technology platform Proof-of-concept • Results published on Nature Biomedical Engineering, “Ultrasensitive detection of circulating tumour DNA 2016 – 2019 via deep methylation sequencing aided by machine
Slide 23: 6-cancer test marker discovery and model training
6-cancer test marker discovery and model training The THUNDER study, 2395 participants A customized panel of 161,984 CpG sites was constructed and validated by public and in-house (cancer: n = 249; non-cancer: n = 288) methylome data, respectively. The cfDNA samples from 1,693 participants (cancer:
Slide 24: 6-cancer test, detection-of-cancer performance in case-control cohorts
6-cancer test, detection-of-cancer performance in case-control cohorts The THUNDER study Accuracy of top Accuracy of top two Data set Specificity (%) Sensitivity (%) predicted origin (%) predicted origins (%) Training set 99.7 (98.9-100.0) 75.2 (70.6-79.4) 89.7 (85.7-92.9) 94.7 (91.5-96.9) Validatio
Slide 25: 6-cancer test, top-predicted-origin performance in case-control cohorts
6-cancer test, top-predicted-origin performance in case-control cohorts The THUNDER study Accuracy of top Accuracy of top two Data set Specificity (%) Sensitivity (%) predicted origin (%) predicted origins (%) Training set 99.7 (98.9-100.0) 75.2 (70.6-79.4) 89.7 (85.7-92.9) 94.7 (91.5-96.9) Validati
Slide 26: Product Development Roadmap
Product Development Roadmap • Proof of concept on our methylation based, machine learning aided technology platform Proof-of-concept • Results published on Nature Biomedical Engineering, “Ultrasensitive detection of circulating tumour DNA 2016 – 2019 via deep methylation sequencing aided by machine
Slide 27: 9-cancer test, multi-omics model
9-cancer test, multi-omics model The PROMISE study PROMISE is a prospective multicenter case-control study to assess the performance of multi-omics including cfDNA methylation, ctDNA mutation and protein biomarkers in the early detection of nine cancers in the biliary tract, colorectum, esophagus, h
Slide 28: 9-cancer test multi-omics model performance
9-cancer test multi-omics model performance The PROMISE study Accuracy of Cancer (n) Non-cancer (n) Specificity (%) Sensitivity (%) top predicted origin (%) Training 470 511 97.9% (96.1%-99.0%) 81.7% (78.1%-84.9%) 86.6% (83.0%-90.0%) Validation 257 235 98.3% (96.6%-99.4%) 83.7% (79.0%-88.0%) 81.9% (
Slide 29: Burning Rock's 22-cancer test covers 88% of China's cancer incidence
Burning Rock’s 22-cancer test covers 88% of China’s cancer incidence China Cancer Incidence1 per 100,000 population, across all ages All cancer types 288 BR-22 254 BR-6 144 Lung Breast Gastric Liver 28 Colorectal 28 Esophagus Cervix Thyroid Prostate Uterus 0 50 100 150 200 250 300 350 Notes: 1 Incid
Slide 30: Leadership in multi-cancer early detection
Leadership in multi-cancer early detection First-in-class, high entry-barrier, multi-year efforts 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 Techno
Slide 31: Appendix 2: MRD
Appendix 2 MRD
Slide 32: How do MRD studies advance utility
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 33: How do MRD studies advance utility: Example 2
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 34: Colorectal cancer cohort publication at AACR 2022
Colorectal cancer cohort publication at AACR 2022 brPROPHETTM demonstrated superior sensitivity and specificity to fixed panel in pre-operative ctDNA detection and post-operative MRD calling among relapsed patients 34
Slide 35: Second colorectal cancer cohort publication at ASCO GI 2023
Second colorectal cancer cohort publication at ASCO GI 2023 brPROPHETTM has high detection Most mutation variants fall outside of brPROPHETTM significantly out-performs sensitivity fixed panels fixed panels Preoperative ctDNA was detected in 97% Only 6% of designed variants were included in Preopera
Slide 36: Pancreatic cancer cohort publication at ASCO GI 2023
Pancreatic cancer cohort publication at ASCO GI 2023 Patients: A total of 20 patients (stage I/II 10 [50.0%] / 9 [45.0%]) were analyzed. 13 (65.0%) patients were treated with adjuvant therapy (AT) after surgery. Samples: Tumor tissue samples were collected at the surgery. Plasma samples collected at
Slide 37: Appendix 3: Therapy selection
Appendix 3 Therapy selection
Slide 38: 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 诺禾 Approved in Aug 2018 NMPA Gen
Slide 39: NGS testing
NGS testing Diagnostics companies focus on steps 1 and 3 Library Preparation NGS EGFR ALK MET Throughput High-throughput 1 Targeted genes enrichment Sequencing Efficiency Parallel testing Cost Low-cost per biomarker 22 Bioinformatics Analysis and Mutation Annotation Biomarker Comprehensive profiling
Slide 40: 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: 40 Slides from “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annua
Slide 41: Participating assays and study design
Participating assays and study design 41 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 42: 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 43: 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