Burning Rock Biotech Ltd. · NASDAQ:BNR
Burning Rock Biotech — Q3 2024 Earnings Presentation
46 slides from Burning Rock Biotech's earnings presentation, Dec 4, 2024
Slide 1: Burning Rock Biotech Limited 3Q 2024 results
Burning Rock Biotech Limited 3Q 2024 results 4 December 2024
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: Recent progress
Recent progress Continued efficiency gains, driving towards profitability Delivering results on 1• Driving sales efficiency • Increasing sales productivity per head • Benefiting from more rational industry competition 2• Improving gross margin • Leveraging our scale • Delivering on margin improvemen
Slide 5: 3Q24 continues to get commercial breakeven under new industry conditions
3Q24 continues to get commercial breakeven under new industry conditions Breakeven defined as Non-GAAP gross profit minus SG&A* Non-GAAP gross profit minus SG&A* (RMB millions) 25.2 18.7 7.6 11.8 (3.8) (8.9) (16.0) (11.1) (36.8) (84.2) First-time breakeven Industry turbulence Breakeven again excludi
Slide 6: Driving sales efficiency
1 Driving sales efficiency Expect below 40% selling expense going forward Non-GAAP sales and marketing expenses as % of revenue* 77% 55% 56% 44% 45% 42% 38% 35% 62% 33% 34% 42% 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 2022 2023 Notes: * Excluding share based compensation (SBC) and depreciat
Slide 7: Improving gross margin
2 Improving gross margin Delivering on margin improvement initiatives Non-GAAP gross profit as % of revenue* 74.3% 73.0% 72.5% 2021 2022 2023 Notes: * Non-GAAP gross margin, which is defined as gross margin excluding depreciation and amortization (D&A) 7
Slide 8: Reducing G&A expenses
3 Reducing G&A expenses Expect additional cost savings going into 2024 General and admin expenses minus noncash items * (RMB millions) 46 226 42 38 35 34 170 27 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 2022 2023 Notes: * Excluding share based compensation (SBC), depreciation and amortization (D&A) and allowanc
Slide 9: Strong cash position to fund operations for the next 3 years
Strong cash position to fund operations for the next 3 years Commercial operation (excluding R&D expenses) reached profitability in 3Q24 On R&D spend, disciplined investment in R&D RMBm 2022 2023 2024E1 2024.01-09 Operating cash outflow2 457 256 111 Capex3 75 9 5 Sum 532 265 c.150-200 116 Cash balan
Slide 10: Financials
Financials Steady progress of improving margins, profitability and reducing cash outflows 3Q24 3Q24 RMB millions 2022 2023 YoY 1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24 YoY QoQ Revenues 563.1 537.3 -5% 142.6 146.2 127.6 121.0 125.6 135.6 128.7 1% -5% Central lab 314.8 232.8 -26% 61.8 66.2 53.5 51.3 47.6 48
Slide 11: Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD)
Slide 12: Burning Rock's MRD clinical publications
Burning Rock’s MRD clinical publications Covering adjuvant and relapse settings in lung, colorectal, gastric and other cancers Resectable Neo- Surgical Adjuvant Relapse Tumor adjuvant Resection The baseline Treatment Landmark MRD Treatment Longitudinal ctDNA level effectiveness effectiveness monitor
Slide 13: Overview of brPROPHET
Overview of brPROPHETTM An ultrasensitive and quantitative MRD assay 13 Source: Chen et al., Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer, Cancer Cell, Sep 2023
Slide 14: MEDAL study
MEDAL study Personalized MRD using brPROPHETTM on non-small cell lung cancer (NSCLC) 14 Source: Chen et al., Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer, Cancer Cell, Sep 2023
Slide 15: Study design
Study design Cohort: 181 patients enrolled Stage I (63%), II (19%), and III (18%) Sampling Time: Tumor and adjacent paired tissue collected at surgery Blood samples collected at Pre-operative, 3 days, and 30 days post-surgery Median Follow-up Time: 30 months 15 Source: Chen et al., Indiv
Slide 16: brPROPHET demonstrates superior sensitivity in ctDNA detection
a b c brPROPHETTM demonstrates superior sensitivity in ctDNA detection Clinical validation with pre-operative plasma samples (a) (b) Sensitivity of pre-operative plasma ctDNA fraction distribution of MRD (+) samples a b detected by different methods c d e f • For pre-operative plasma from patients w
Slide 17: brPROPHET shows strong prognostic value in post-surgery NSCLC patients
brPROPHETTM shows strong prognostic value in post-surgery NSCLC patients Prognostic analysis at Landmark time points Longitudinal MRD analysis 17 Source: Chen et al., Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer, Cancer Cell,
Slide 18: Early detection
Ps elisa Burning Rock Dx Early detection
Slide 19: Burning Rock's multi-cancer early detection technology
Burning Rock’s multi-cancer early detection technology Competitive technology Methylation + machine learning to overcome challenges of low ctDNA abundance Multi-cancer validation data AACR 2022 ESMO 2022 breakthrough device designation granted Regulatory breakthrough China NMPA breakthrough designat
Slide 20: 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 21: 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 22: Appendix 1: Early detection
Burning Rock Dx Appendix 1 Early detection
Slide 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: 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 32: Appendix 2: MRD
Appendix 2 MRD
Slide 33: 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 34: 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 35: 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 36: 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 36 Source: Xue et al., Circulating tumor DNA based molecu
Slide 37: 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 37
Slide 38: 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 39: 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 40: Appendix 3: Therapy selection
Appendix 3 Therapy selection
Slide 41: 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 42: 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 43: 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: 43 Slides from “Establishing the analytical validity of circulating tumor DNA sequencing for precision oncology“, 5th Annua
Slide 44: Participating assays and study design
Participating assays and study design 44 Source: “Evaluating the analytical validity of circulating tumor DNA sequencing assays for precision oncology“, Nature Biotechnology, Apr 2021
Slide 45: 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 46: 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