Guardant Health, Inc. · NASDAQ:GH
Guardant Health — J.P. Morgan 42nd Annual Healthcare Conference (January 2024)
36 slides from Guardant Health's conference presentation, Jan 8, 2024
Slide 1: Transforming Cancer Care
Transforming Cancer Care J.P. Morgan Healthcare Conference January 8, 2024
Slide 2: Safe harbor
Safe harbor Certain statements in this presentation and the accompanying oral commentary are forward-looking important factors may cause actual results, performance or achievements to differ materially from those statements within the meaning of federal securities laws. These statements relate to fu
Slide 3: Guardant Health was founded with the mission to give us all more time free from cancer
Guardant Health was founded with the mission to give us all more time free from cancer
Slide 4: Transforming patient lives across the continuum of cancer care
Transforming patient lives across the continuum of cancer care Planned IVD launch in 2024 Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care 4
Slide 5: Strong record of execution
Strong record of execution $562-563M1 500,000+ + 44% Cumulative tests ordered2 $450M CAGR $1.2B $374M $287M Cash, cash equivalents & $214M marketable debt securities1 $91M Cash flow 2018 2019 2020 2021 2022 2023 breakeven in Therapy Selection1 1. Preliminary, unaudited full year 2023 results provide
Slide 6: Leading in liquid biopsy for Therapy Selection
Leading in 700K liquid biopsy Total U.S. Advanced Cancer Patients for Therapy Selection $10B Total U.S. Addressable Market Sources: Therapy selection TAM is Stage IV patients., Data from internal modeling that sources information from US Cancer Statistics; SEER, CancerMPact®, NODA data, Treatment Ar
Slide 7: Comprehensive portfolio for Therapy Selection with broad payer coverage
Comprehensive portfolio for Therapy Selection with broad payer coverage 1st FDA-Approved Next-Generation 1st Blood-Only Next-Generation Comprehensive Liquid Biopsy Liquid Biopsy to Tissue Assay Liquid Biopsy Assay Monitor Tx Response Reimbursed by Medicare 7
Slide 8: Guardant360 has been the primary driver of volume growth
43% Guardant360 Clinical Volume CAGR 173K has been the 125K primary driver 88K of volume 63K 50K growth 29K 2018 2019 2020 2021 2022 2023 Source: Preliminary, unaudited full year 2023 results provided on January 8, 2023 8
Slide 9: Guardant360 ASP trend benefiting from multiple tailwinds
Guardant360 ASP trend benefiting from multiple tailwinds Guardant360 ASP Guardant360 LDT crosswalked to CDx rate for CMS reimbursement $2,850 - $2,900 From $3,500 to $5,000 $2,650 - $2,700 Effective January 1, 2024 Additional ASP tailwinds from further commercial payer wins Q3 2023 Q1 2024E 9
Slide 10: Guardant has created momentum for National Biomarker Testing Coverage
Guardant has created momentum for National Biomarker Testing Coverage State Biomarker Legislation 15 States enacted laws for biomarker testing Enacted NY + CA (signed into law) In current legislative process Introduced but did Recently enacted with coverage for not advance Guardant360, TissueNext, R
Slide 11: Therapy Selection utilization will continue to grow
Therapy Selection utilization will continue to grow Increase liquid and Unlock new actionable Physicians are using CGP tissue adoption biomarkers and use cases testing in earlier lines New 2024 NCCN Lung Guidelines now include concurrent testing with BOTH liquid and tissue to maximize sensitivity an
Slide 12: EMR integration accelerates access to critical information
EMR integration accelerates access to critical information Current partnerships will cover Integrated into Integration leads to 65% of U.S. oncologists1 >475 accounts at year 75% reduction in end1 ordering time2 1. Guardant Health data on file. 2. Lao-Min KS et al 12
Slide 13: Launching Smart Liquid Biopsy for Guardant360 in 2024
Launching Smart Liquid Biopsy for Guardant360 in 2024 Comprehensive MOLECULAR Profiling: Epigenomics will fuel next wave of precision oncology Identify more patients for existing targeted therapies undetectable by current CGP tests Identify novel targets for the next generation of targeted therapies
Slide 14: International volumes will be a tailwind in 2024
International volumes will be a tailwind in 2024 Guardant360 CDx launched for Expanding into the UK by testing clinical use in Japan advanced cancer patients National reimbursement approval from the Royal Marsden’s Guardant-powered laboratory Japanese MHLW for Guardant360 CDx awarded expression of i
Slide 15: Partnership with Hikma to offer Guardant tests in the Middle East and North Africa
Partnership with Hikma to offer Guardant tests in the Middle East and North Africa • Leading global healthcare company with a robust commercial oncology presence in Middle East and North Africa (MENA) >400K New cancer cases per 2x Expected increase in • Partnership to offer Guardant360, year in the
Slide 16: Multiple drivers of biopharma growth
Multiple drivers of biopharma growth 26,000 29,900 15% >165 Lifetime biopharma partners Including 19 out of the top 20 pharma partners YoY Growth >30 Partnerships in the pipeline for China >30% Of biopharma volumes are Guardant Infinity 2022 2023 Source: Preliminary, unaudited full year 2023 results
Slide 17: Therapy Selection has multiple near-term growth drivers
Therapy Selection has multiple near-term growth drivers Portfolio ASP Transition to EMR integration & increases Smart Liquid Biopsy Key partnerships International Biopharma partnerships TissueNext & expansion & CDx approvals Response uptake 17
Slide 18: Paving the way for tissue-free MRD
Paving the 15M Total U.S. Patients way for tissue-free MRD $20B Total U.S. Addressable Market Sources: ACS Cancer Treatment & SurvivorshipFacts & Figures 2019-2021 2 Guardant assessment based on tissue availability post diagnosis. The ACS Cancer Treatment & SurvivorshipFacts & Figures 2019-2021 stat
Slide 19: The future of MRD is tissue-free
The future of MRD is tissue-free Faster Easier Powerful Decreased initial turnaround No need for tissue access Ability to inform clinicians time to inform adjuvant for patients in the with precision, detection of decision making or to start neoadjuvant, adjuvant heterogeneous cancers, initial survei
Slide 20: The only tissue-free MRD test available clinically
Launched Smart Liquid Biopsy to achieve even higher performance for MRD The only tissue-free MRD test available clinically Methylome-wide panel enables hypersensitive MRD detection across 100s of features per patient, without tissue Precise epigenomic-based tumor fraction quantification for disease
Slide 21: Smart Liquid Biopsy MRD data: COSMOS-Colon surveillance
Smart Liquid Biopsy MRD data: COSMOS-Colon surveillance Stage II/III colon cancer 120 Sensitivity by site of metastasis 80% 99% 100 100 0 100 100 100 ctDNA Detection Rate (%) 80 86 80 Surveillance Specificity 75 Sensitivity Sample-level 60 801 samples from 136 patients 50 50 40 45 33 33 Data to be i
Slide 22: Smart Liquid Biopsy MRD data: breast cancer publications in preparation
Smart Liquid Biopsy MRD data: 3 breast cancer publications in preparation Pooled Analysis Across Cohorts: 82% Surveillance 97% Specificity Cohort STUDY 1 Description Multi center Patients >300 Plasma time points >300 STUDY 2 Single center >100 >500 Sensitivity Sample-level Distant recurrence STUDY 3
Slide 23: Deep Reveal clinical data pipeline: 80K samples from 20K patients across solid tumors
Deep Reveal clinical data pipeline: 80K samples from 20K patients across solid tumors Indication Specific Studies 1H 2024 2H 2024 1H 2025 2H 2025 CRC Surveillance COSMOS Breast Multiple Lung SMC Pancreatic COSMOS Gastric COSMOS Longer term Phase II Phase III Phase III prospective trials PEGASUS TRAC
Slide 24: Pioneering a new category of cancer screening
Pioneering a 120M Average-risk U.S. new category Individuals of cancer screening $50B Total Addressable U.S. Market Sources: AACR Study, Cancer Prev Res (2020) 24
Slide 25: Game changing blood-based screening will save lives
Game changing blood-based screening will save lives Metastatic Local 14% Survival 90% Survival Statistics from 26 Pleasant Consumer different cancers Regional Experience comprising 87% of all cancers in US High Performance MCED Test 65% Survival Sources: SEER.cancer.gov. . Siegel, et al. Cancer stat
Slide 26: Significant opportunity in unscreened patient population for CRC
Significant opportunity in unscreened patient population for CRC 50M Unscreened individuals 2 120M Avg-risk individuals FIT 4 10% (7M) (Ages 45 – 85)1 70M Screened individuals 2 77% (54M) 13% Cologuard 5 Colonoscopy 3 (9M) 1. AACR Study, Cancer Prev Res (2020) 13. 2 ACS Colorectal Cancer Facts 2020-
Slide 27: Lack of screening compliance significantly impacts lives lost to colorectal cancer
Lack of screening compliance significantly impacts lives lost to colorectal cancer 50M 76% Of CRC deaths are in Unscreened individuals1 individuals not up to date with screening2 Sources: 1. ACS Colorectal Cancer Facts 2020-2022. 2. Doubeni CA, et al. Gastroenterology. 2019;156(1):63-74.e6 27
Slide 28: Completed enrollment of ECLIPSE registrational study
Completed enrollment of ECLIPSE registrational study Samples used in PMA submission ~ 23K 45K Individuals enrolled ~ 22K Blinded bio- banked samples Shield performance is in range with other guideline recommended modalities Available to be used CRC Sensitivity 74% 83% 92% for future IVD Specificity
Slide 29: Launching Shield IVD following FDA approval
Launching Shield IVD following FDA approval Growth is stage-gated by market conditions allowing for steady growth while ring- fencing expenses 2024 2025 2026 • Advisory Panel • ADLT Status • USPSTF Guidelines • FDA Approval • Improved Medicare • Expanded Market Pricing Opportunity • Shield IVD Launc
Slide 30: Unprecedented compliance for Shield experienced by PCPs and health systems
Unprecedented compliance for Shield experienced by PCPs and health systems Patient preferred blood test modality Prospective Study with drives higher compliance Kaiser Permanente3 Randomized study offering Shield 94% blood test to patients that haven’t completed FIT Participants were Adherence rate
Slide 31: What our ordering PCPs are saying…
Previously, when we look at Colonoscopy and Cologuard combined, compliance was around 45 to 50%. My compliance rate using Shield has now skyrocketed to 95%. - Dr. Monnie Singleton, MD Orangeburg, South Carolina Many of our patients face barriers to current screening options including lack of transpo
Slide 32: Next step to multi-cancer is adding lung indication
Next step to multi-cancer is adding lung indication Multi-Cancer … CRC + Lung CRC 32
Slide 33: Preliminary, unaudited full year 2023 results
Preliminary, unaudited full year 2023 results Total Revenue (M) Clinical Volumes (K) Biopharma Volumes (K) 25% 172.9 39% 29.9 15% $562-$563 YoY Growth 124.8 YoY Growth YoY Growth 26.0 $450 FY 2022 FY 2023 FY 2022 FY 2023 FY 2022 FY 2023 Preliminary, unaudited full year 2023 results provided on Janua
Slide 34: Current cash provides runway to reach cash flow breakeven
Current cash provides runway to reach cash flow breakeven 2022 2023 2024 2025 2026 2027 2028 • $1.2B cash at YE Cash flow breakeven • Reached Therapy Selection breakeven end of 2023 • Systematically reducing cash burn in 2024 and beyond • Combined Therapy Selection + MRD generates positive cash flow
Slide 35: Transforming patient lives across the continuum of cancer care
Transforming patient lives across the continuum of cancer care Therapy Selection MRD Screening Profitable core business Data publications for Shield FDA approval CRC and Breast Increased G360 ASP Shield Medicare MolDX submissions reimbursement Launch of Smart Liquid Biopsy for G360 Volume growth Shi
Slide 36: () GUARDANT.
() GUARDANT.
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