Guardant Health, Inc. · NASDAQ:GH
Guardant Health — Investor Day (September 2023)
165 slides from Guardant Health's investor day presentation, Sep 7, 2023
Slide 1: Investor Day Presentation
Investor Day Presentation September 7, 2023
Slide 2: Transforming patient lives across the continuum of care
Transforming patient lives across the continuum of care Helmy Eltoukhy, PhD AmirAli Talasaz, PhD co-Chief Executive Officer, co-Founder co-Chief Executive Officer & co-Founder & Chair of the Board
Slide 3: Safe harbor and non-GAAP disclosures
Safe harbor and non-GAAP disclosures 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. Thes
Slide 4: Today's agenda
Today’s agenda 8:00 am Welcome and opening Helmy Eltoukhy (co-CEO) and AmirAli Talasaz (co-CEO) 8:15 am Data generation driving future expansion Darya Chudova (Chief Technology Officer) 8:45 am Leading in liquid biopsy for therapy selection Craig Eagle (Chief Medical Officer) 9:05 am Paving the way
Slide 5: 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 5
Slide 6: On this mission to conquer cancer, our weapon of choice is data
On this mission to conquer cancer, our weapon of choice is data 6
Slide 7: Paradigm shifts have driven exponential increases in data generation and acquisition
Paradigm shifts have driven exponential increases in data generation and acquisition 1015 1010 105 100 10-5 Electromechanical Relay Vacuum Tube Transistor Integrated Circuit 10-10 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 7 Kurzweil, Ray. The Singularity is Near [archive.org]. New
Slide 8: The Liquid Biopsy Paradigm
cell-free DNA + other biomarkers The Liquid Biopsy Paradigm has fueled exponential increases in cancer data and outcomes improvement 8
Slide 9: Paradigm shifts are not easy
Paradigm shifts are not easy Liquid biopsy… “ …cannot detect late- “ …is too expensive “ …is unproven “ …only detects stage cancer in to run at scale.” and unreliable.” uninformative cancer blood.” information in blood.” “ …will only be used “ …cannot achieve high “ …cannot detect Stage I-III for ni
Slide 10: Product launches across the cancer care continuum
Product launches across the cancer care continuum FDA-approval Guardant Health Founded IPO 2012 2014 2017 2018 2020 2021 2022 10
Slide 11: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Cancer Individuals and Survivors Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 12: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 13: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 14: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 15: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 16: We have helped hundreds of thousands of patients and unlocked petabytes of clinical data
We have helped hundreds of thousands of patients and unlocked petabytes of clinical data Exponential genomic data generation1 Cumulative patient tests >500K PBs of Data Unlocked 20+ 500K+ Petabytes Tests Current ordering oncologists >12K Bio-banked samples >500K 2015 Aug 2023 1. Guardant Bioinformat
Slide 17: Guardant today
Guardant today $548M 160+ 60+ 600+ 2023 Revenue Biopharma Countries Global Patents & Guidance Midpoint1 Partners Patent Applications 1 FY 2023 Revenue guidance of $545 - $550M updated August 3, 2023 17
Slide 18: Our values drive us forward
Our values drive us forward Put patients Be stronger Blaze a Make every first together trail moment matter Our commitment to Our commitment to Our commitment to Our commitment to treat them as our teamwork & caring innovation excellence, velocity own family for each other and impact 18
Slide 19: Employee approval rating
80% TM Employee approval rating 195+ 1,700+ PhDs & MDs Employees 56% 60% Female Ethnically diverse As of December 31, 2022 19
Slide 20: This is just the beginning…
This is just the beginning… 20 20
Slide 21: Data generation driving future expansion
Data generation driving future expansion Darya Chudova Chief Technology Officer
Slide 22: Guardant Health pioneered liquid biopsy
Guardant Health pioneered liquid biopsy Novel Next-generation AI-powered Patient biochemistry sequencing techniques bioinformatics report 22
Slide 23: Extending from advanced disease to early stage and screening required a technology paradigm shift
Extending from advanced disease to early stage and screening required a technology paradigm shift. 23
Slide 24: Smart Liquid Biopsy platform
Smart Liquid Biopsy platform The power Enhanced Delivering of liquid biopsy by epigenomics performance & scale • Simple blood draw • Deeper tumor sensing • Proprietary biochemistry with high sensitivity / • Tissue-site agnostic • Wider biological view specificity • Captures whole • Efficient COGS bo
Slide 25: There are 37.2 trillion cells in the human body and they all share one genome
There are 37.2 trillion cells in the human body and they all share one genome 25
Slide 26: Epigenomics is the missing link in understanding human disease
Epigenomics is the missing link in understanding human disease 26
Slide 27: Methylation is a key determinant of the epigenomic state
Methylation is a key determinant of the epigenomic state Epigenomic state Gene Unmethylated Gene A may be functionally active controls how our cells function Blood cell ON Methylated Gene A is silenced Liver cell OFF Single Genome Genome 10,000s of epigenomic switches Variable methylation state Bloo
Slide 28: Epigenomic state change is wide throughout the genome
Epigenomic state change is wide throughout the genome 1,000s CRC Samples Of differentially methylated Healthy regions form cancer or cell type specific fingerprints Differentially Methylated Regions 28
Slide 29: Number of detectable tumor alterations drives sensitivity
Number of detectable tumor alterations drives sensitivity Genomic analysis Tissue Informed Assays Up to 50 Tumor Alterations Epigenomic analysis Smart Liquid Biopsy >1,000 Tumor Alterations 29
Slide 30: Smart Liquid Biopsy unlocks both genomic and epigenomic state
Smart Liquid Biopsy unlocks both genomic and epigenomic state Smart Liquid Biopsy: Guardant’s proprietary technology Circulation Methylation-based Sequencing Decoding Feature Extraction AI-Powered Analysis: Encoding Quantify and Characterize Epigenetic changes Cancer State Chr 1:501-688 Per-region M
Slide 31: Smart Liquid Biopsy: key technology differentiators
Smart Liquid Biopsy: key technology differentiators Single sample Genome wide Highly efficient Background Continuous workflow for profiling molecule capture depletion for improvement powered by efficiency for optimal optimal cost samples & data detection bank Genomic mutations + >20X more detectable
Slide 32: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 33: Do I have cancer?
1 Do I have cancer? 1% Stage IV Detection Limits of Genomic Panels Stage III 0.1% Clinically relevant CRC Stage II 50X detection capability achieved improvement 0.01% by epigenomics assay for Current Epigenomic Detection Limits3 Stage I screening applications1,2 0.001% 1. Avanzini et al., Sci Adv 6(
Slide 34: Do I still have cancer? Has my cancer returned?
2 Do I still have cancer? Tumor Fraction Level for Reliable Detection1 at Has my cancer returned? Cancer type the most challenging input level of 5ng CRC 0.01% Lung 0.01% Clinically relevant Minimal Residual Disease (MRD) Breast 0.015% detection capability for tissue-free assay achieved by epigenomi
Slide 35: Am I responding to therapy? Should I switch therapy?
3 Am I responding to 3X higher precision1 of epigenomics enables to see therapy response clearer and make better patient management decisions therapy? Should I Genomic Assessment Epigenomic Assessment switch therapy? No change Significant change High precision of tumor fraction estimates is attained
Slide 36: What kind of therapy is best for me?
4 What kind of therapy Current best-in-class liquid biopsy for therapy selection and translational research Expanded genomic and epigenomic capability offered with Smart Liquid Biopsy i g e n o me S t a te SNVs/Indels Ep is best for me? ne Immu State e n t S t a te Amplifications Pa t i s s u e o f
Slide 37: What kind of therapy is best for me? Breast cancer
4 What kind of therapy Breast Cancer Expanded patient eligibility for targeted therapy through promoter methylation is best for me? BRCA1 ~24% of TNBC patients are associated with promoter BRCA1 methylation1 Promoter Epigenomics unlocks Methy Without analyzing both mechanisms of regulation that late
Slide 38: What kind of therapy is best for me? Colorectal cancer
4 What kind of therapy Colorectal Cancer Expanded patient eligibility for targeted therapy through promoter methylation is best for me? MLH1 MLH1 promoter methylation identified Epigenomics unlocks additional 7% of MSI-H patients missed by mechanisms of regulation that genomic testing alone are invi
Slide 39: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 40: Where is my cancer?
5 Where is my cfDNA methylation encodes tissue of origin Tissue Blood cancer? Bladder Bladder Colon Breast Breast Colon Tissue-specific fingerprints are detectable with Smart Liquid Biopsy Lung Lung Data from Loyfer et al., Nature 613 (2023) 40
Slide 41: What kind of cancer do I have?
5 What kind of cfDNA methylation encodes cancer subtype cancer do I have? HR- HR+ / HER2+ HR+ HR- Fingerprints differentiating HER2- breast cancer subtypes are detectable with Smart Epigenomic profiles derived from plasma of breast cancer Liquid Biopsy patients may enable precision diagnostics and p
Slide 42: Future unified platform will drive significant R&D efficiency and operating leverage
Future unified platform will drive significant R&D efficiency and operating leverage Smart Liquid Biopsy • Leveraged performance improvements Operating • Lower COGS R&D efficiency • Cross-development of new applications leverage • Fast turnaround time 42
Slide 43: Power of More Data
Power of Continuous improvement Continuous improvement More Data 1% 1% Tumor Fraction, % 0.1% 0.1% Learning from data for continuous improvement 0.01% 0.01% Technology Paradigm Shift Technology paradigm shift for radical 0.001% 0.001% change in capability Data growth Data growth Source: Internal dat
Slide 44: Smart Liquid Biopsy will continue to unlock the rich landscape of blood-based markers
Smart Liquid Biopsy will continue to unlock the rich landscape of blood-based markers immune NETs cells apoptotic bodies TEPs micro-vesicles microbiome genome-wide fragmentation fragments chromatin ending exomeres organization virome point mutations topology epigenetic TLR exosomes alterations recep
Slide 45: Leading in liquid biopsy for Therapy Selection
Leading in liquid biopsy for Therapy Selection Craig Eagle, MD Chief Medical Officer
Slide 46: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 47: 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 Tissue Assay Liquid Biopsy Assay to Monitor Tx Response Reimbursed by Medicare Guardant internal data on file 9
Slide 48: Guardant360 in lung cancer
Guardant360 in lung cancer Diagnosis with metastatic CD74-ROS1- Progression in bones positive lung cancer Progression in and lymph nodes brain and bones Entrectinib dose escalation (800 mg) Detection of ROS1 Detection of ROS1 L2086F resistance Undetectable Progression F2004V resistance Progression m
Slide 49: 425+ publications supporting use of Guardant360
425+ publications supporting use of Guardant360 Pancreatic Partnership with Top Thought Leaders ers Patient Outcomes Oth Al l 45 120+ GU NCI-Designated Comprehensive Cancer Centers involved in Publications with patient outcomes L u ng publication generation involving targeted therapies Breast 425+ P
Slide 50: Because precision and speed impact patients
Because precision and speed impact patients Association Between Availability of Molecular Genotyping Results and Overall Survival in Patients with Advanced Nonsquamous Non-Small-Cell Lung Cancer2 CGP results in 4x better patient outcomes Every month delayed in cancer treatment can raise risk of deat
Slide 51: Overcomes limitations of existing tools used to measure treatment response
Overcomes limitations of existing tools used to measure treatment response Accelerated insight into Advantages of a Improved sensitivity Real-time clinical treatment response tissue-free approach and precision with decision making methylation Measure ctDNA change Overcome logistical Guardant360 Resp
Slide 52: Response can determine which patients are responding to therapies sooner than CT-scans
Panelists Response can determine which patients Guardant360 are responding to therapies sooner than CT-Scans ctDNA and RECIST 44% 44% 41% identify responders… 36% 33% Molecular responders 24% RECIST responders Study A (solid tumors) Study A (NSCLC) Study C (solid tumors) Median of 8 weeks …but ctDN
Slide 53: Advancing Guardant360 TissueNext with AI-powered digital pathology
Advancing Guardant360 TissueNext with AI-powered digital pathology Only tissue CGP panel Now validated for Covered by Medicare with an AI-powered multiple cancers2 for all advanced solid scoring algorithm that tumors3 improves PD-L1 detection by >20% in NSCLC1 AI = Artificial Intelligence. *Compared
Slide 54: FDA-approved targeted therapy options are continuing to rapidly expand across solid tumors
FDA-approved targeted therapy options are continuing to rapidly expand across solid 89 (11) tumors (7) 78 (12) (10) 71 (2) 59 (11) (5) 47 49 (6) (New) 36 Cumulative (6) 31 (1) (5) 25 (3) (2) 19 (3) 14 (1) (2) (1) (1) 8 11 13 3 4 5 1 2001 2003 2004 2005 2006 2007 2009 2010 2011 2012 2013 2014 2015 20
Slide 55: Emerging mutation with high unmet need
Spotlight on ESR1 ~67%–80% of breast cancers in women are ER+, HER2-1 Emerging Breast cancer is the ~298k new cases and ER+ tumors have a high mutation with second leading cause of cancer death in women ~44k deaths estimated in 2023 alone likelihood of developing ESR1 mutation high unmet need fuelin
Slide 56: The need for therapy selection in oncology is growing rapidly
Expanding utility in additional cancers Greater need for biomarker testing across all cancers The need for therapy selection Treatment in oncology is Window More lines of growing rapidly therapies More tests per patient as survival improves Low background methylation Larger patient chemistry populat
Slide 57: Advancing Therapy Selection with Smart Liquid Biopsy
Advancing Therapy Selection with Smart Liquid Biopsy Research CRC Lung Pipeline Lung 5% 17% Gyn 20% RCC 10% 12% 22K Samples Spanning Gyn Across >10 Multiple 6,500 17% 14% Indications Breast Patients Multiple 24% 21% Breast Prostate 14% 17% Prostate 17% Internal data as of September 1, 2023 57
Slide 58: Paving the way for tissue-free MRD
Paving the way for tissue-free MRD Helmy Eltoukhy, PhD co-Chief Executive Officer & Chair
Slide 59: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 60: The only tissue-free MRD test available clinically
$20B+ The only tissue-free MRD U.S. market in test available clinically early development Currently in CRC, breast and lung Upgrade to Smart Liquid Biopsy this year 15M+ <3% Patients Patients tested today 1 ACS Cancer Treatment & SurvivorshipFacts & Figures 2019-2021 2 Guardant assessment based on t
Slide 61: 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 62: But tissue-free detection is hard
But tissue-free detection is hard How can one reliably detect cancer with high sensitivity and specificity without tissue? 62
Slide 63: Blazing a trail for a true liquid MRD test
Blazing a trail for a true liquid MRD test 1 2 3 Revolutionary Smart Liquid Clinical validation on Leverage existing Biopsy technology thousands of patients market-leading oncology achieving high sensitivity across dozens of tumor commercial with >98% clinical types to secure infrastructure to scale
Slide 64: How does our Smart Liquid Biopsy technology achieve high performance for MRD?
CRC 1 Healthy 1,000+ Differentially Methylated Regions How does our (Smart Liquid Biopsy) Smart Liquid >1,000 alterations Current Medicare- Biopsy technology Reimbursed MRD tests achieve high performance for 16 48 MRD? Low background Machine-learning High sensitivity Genome- methylation wide detecti
Slide 65: Clinical validation of any new MRD test requires a significant number of samples
2 # of indications Clinical validation of any new MRD test requires a significant number of samples with years of follow-up 10,000s of clinical samples 65
Slide 66: 80K MRD samples for Smart Liquid Biopsy clinical studies
2 Near-term Clinical Validity & Utility Cohorts Plasma Indication Description Patients Timepoints CRC COSMOS >300 >2,000 IO monitoring Multi-center >1000 >3,000 17 80K Breast Multi-center >300 >300 Solid tumor Lung Single center >300 >700 types Breast – TNBC Single center >100 >500 Breast – Mixed Si
Slide 67: New data: Smart Liquid Biopsy MRD
New data Smart Liquid Biopsy MRD 67
Slide 68: COSMOS-Colon Update: Stage II/III completely resected population
COSMOS-Colon Update: Stage II/III completely resected (R0) population RFS Based onRFS4 Week BasedPost-Surgery on 4 week ctDNA Detection Post-Surgery ctDNA Detection +/- ACT 100 ctDNA Not Detected (n=121) Recurrence-Free Survival Probability of ctDNA Detected (n=14) 80% 99% 50 HR 10.8 (95% CI, 1.98-6
Slide 69: Highlights of additional MRD studies underway
Highlights of additional MRD studies underway Near-term readouts Long-term readouts Breast Cancer PEGASUS TRACC Part C Clinical Validity Study De-Escalation Clinical Utility Trial De-Escalation Clinical Utility Trial (Standard of Care Chemotherapy) CRC (Standard of Care Chemotherapy) CRC • Post-adju
Slide 70: We can tap into our 380+ Oncology commercial teams
3 Reimbursement-gated Volume Trajectory Volume We can tap into our 380+ … Oncology, and, over time, Lung Screening ASP Breast commercial teams CRC to efficiently surveillance commercialize MRD 70
Slide 71: The future of oncology is one precision medicine paradigm for all patients
The future of oncology is one precision medicine paradigm for all patients Biomarker driven therapies move earlier More lines of therapies Monitoring across all stages Early Smart Liquid Advanced Cancer Biopsy Cancer 71
Slide 72: Imagine a future in which a simple blood test offers comprehensive information
Imagine a future in which a simple blood test offers comprehensive molecular, spatial and prognostic information streamlining patient care 72 72
Slide 73: Our Smart Liquid Biopsy Platform can make that vision a reality
Our Smart Liquid Biopsy Platform can make that vision a reality 73
Slide 74: A leading commercial platform in oncology
A leading commercial platform in oncology Chris Freeman Chief Commercial Officer
Slide 75: Setting a new standard for patient care and customer experience
Setting a new standard for patient care and customer experience Cutting-Edge Operational Customer Payer Products Excellence Service Coverage A shared commercial infrastructure across the end-to-end product portfolio 75
Slide 76: Significant untapped potential in the Therapy Selection market
Significant untapped potential in the Therapy Selection market 700K Total Patients $10B Total 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 76 Architect
Slide 77: Guardant360 has established footholds in the major tumor types
Guardant360 has established footholds in the major tumor types for Therapy Selection 19% 21% 15% NSCLC Breast CRC 240K 119K 103K Total Patients TAM is Stage IV patients, Data from internal modeling that sources information from US Cancer Statistics; SEER, CancerMPact®, NODA data, Treatment 77 Archit
Slide 78: Therapy Selection utilization will continue to grow
Therapy Selection utilization will continue to grow 1 2 3 Increase liquid and tissue Unlock new actionable Physicians are using adoption biomarkers and use CGP testing in earlier cases lines 78
Slide 79: Industry-leading product portfolio with revolutionary technology
Industry-leading product portfolio with revolutionary technology 1st FDA-Approved Next-Generation Next-Generation Comprehensive Liquid Biopsy Liquid Biopsy Assay Tissue Assay 1st Blood-Only Recurrence Monitoring 1st Blood-Only Liquid Biopsy Assay to Monitor Tx Response Reimbursed by Medicare 79
Slide 80: Portfolio offering provides strategic advantage
Portfolio offering provides strategic advantage +139% 69% Of oncologists choose their testing partner based on “one-stop-shop” ordering1 2020 2021 2022 H1 2023 Market adoption of concurrent blood and tissue testing *Stated use of liquid and tissue CGP prior to 1L NSCLC treatment. 2019 – 2022 are ave
Slide 81: Guardant innovations have helped influence ~500K cancer care decisions
Guardant innovations have helped influence ~500K cancer care decisions 2016 2017 2018 2019 2020 2021 2022 81
Slide 82: Best-in-class products are supported with best-in-class operations
Best-in-class products are supported with best-in-class operations 5 days >60% #1 Median Guardant360 CDx Industry leading turnaround of oncologists are turnaround time1 time for an FDA approved motivated by a FAST CGP turnaround time when choosing a testing partner2 1. Guardant Health, data on file.
Slide 83: Actionable information and speed saves patient lives
Actionable information and speed saves patient lives Association Between Availability of Molecular Genotyping Results and Overall Survival in Patients with Advanced Nonsquamous Non-Small-Cell Lung Cancer 4x Better patient outcomes with CGP testing Every month delayed in cancer treatment can raise ri
Slide 84: Commercial excellence begins with a world-class field team
Commercial excellence begins with a Key Account Team Research & Collaborations world-class Managed Care Medical Affairs field team Client Services Unified CRM Platform Marketing Field Genomic Sales Specialists Account Level Integration #1 Rated Field Team1 #1 Rated Support1 #1 In-Person Share of Voi
Slide 85: EMR integration accelerates access to critical information
EMR integration accelerates access to critical information Our EMR partnerships EMR integration Guardant will be EMR will cover 65% of all reduces oncologist integrated in >400 oncologists in the ordering time by accounts by end of 2023 U.S.1 75%2 1. Guardant Health data on file 2. Lao-Min KS et al
Slide 86: Broad coverage provides seamless access for patients
Broad coverage provides seamless access for patients 300M+ Covered lives for Guardant360 Approaching for Multi-Cancer 200M Covered lives for TissueNext 86
Slide 87: Guardant has created momentum for National Biomarker Testing Coverage
Guardant has created momentum for National Biomarker Testing Coverage In many cases will support private payer coverage for both Therapy Selection and MRD 12 State Biomarker Legislation states enacted laws for biomarker testing Enacted (signed into law) Passed legislation 5+ (pending gubernatorial a
Slide 88: MRD market is largely untapped
MRD market is largely untapped 15M+ $20B+ Total Patients Total Addressable <3% Current Testing Market Penetration Early + late stage monitoring TAM inclusive of stages II-IV and some stage I, depending on cancer type Revenue is based on 2026 projected ASP 88
Slide 89: MRD business can leverage the commercial infrastructure of Therapy Selection
MRD business can leverage the commercial infrastructure of Therapy Selection to scale at speed Customer Access EMR Integration + Key Back End Portal + Digital Sales & Dedicated Guardant Access Mobile to Data Account partnership Operations Ordering Support Team Program + Managed Care Phlebotomy Custo
Slide 90: Commercial excellence unlocks additional growth opportunities
Commercial excellence unlocks additional growth opportunities Integrated Biopharma Global account-level collaborations expansion partnerships 90
Slide 91: Biopharma partnerships fuel clinical growth
Biopharma partnerships fuel clinical growth Including 19 of top 20 pharma 160+ Multiple active CDx collaborations Lifetime biopharma CDx approvals help drive clinical growth partners (e.g., ESR1 for breast cancer) 91
Slide 92: Global commercial organization
Global commercial organization Partnership UK 60+ SEATTLE, WA with Royal Marsden Hospital Countries REDWOOD CITY, CA London PALO ALTO, CA JAPAN SAN DIEGO, CA SPAIN SPRING, TX CHINA Guardant Partnership Partnership Health Japan Lab footprint with Vall with Adicon Tokyo d’Hebron Shanghai Guardant Heal
Slide 93: National reimbursement in Japan & lab launch in China taps into large global market
National reimbursement in Japan & lab launch in China taps into large global market Japan Potential for rapid growth: 1M new cancer cases per year1, centralized care, <10% penetration of CGP market2 Driving business: National reimbursement approval from the Japanese MHLW for Guardant360 CDx + effici
Slide 94: Commercial excellence positions Guardant to lead the future of oncology testing
Commercial excellence positions Guardant to lead the future of oncology testing #1 Liquid biopsy CGP market share 1 Field team overall satisfaction 2 Share of voice 1 1. Guardant360 Brand Tracker Q4 2022; 250+ team rated first in customer satisfaction by HCPs for past 7 quarters; 50% more oncology i
Slide 95: Investor Day 2023
INVESTOR |20 DAY |23 © GUARDANT
Slide 96: Pioneering a new category of cancer screening
Pioneering a new category of cancer screening AmirAli Talasaz, PhD co-Chief Executive Officer & co-Founder
Slide 97: Screening, Minimal Residual Disease, Therapy Selection
Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care >120M >15M >700K Average-Risk Early-Stage Patients Advanced Individuals and Survivors Cancer Patients Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd
Slide 98: Blood-based screening will change the cancer screening landscape
Blood-based screening will change the cancer screening landscape Metastatic 14% Survival Local Statistics from 26 different cancers comprising 87% of all cancers in U.S. 90% Survival Pleasant Consumer Regional Experience High Performance MCED Test 65% Survival Sources: SEER.cancer.gov. . Siegel, et
Slide 99: A successful screening modality requires four components
2 High performance in detecting early- stage cancer Broad reimbursement A successful 1 & access screening modality requires four Positive unit components economics 3 to scale Patient preference 4 99
Slide 100: The future of screening is a high-performance blood-based test for multi-cancer
2 High performance in detecting early- stage cancer Broad The future of 1 reimbursement & access screening is a high- performance blood-based test Positive unit 3 for multi-cancer economics to scale Patient preference 4 100
Slide 101: We strategically started with CRC as the first indication for Shield
2 Demonstrated high performance in detecting early- Established stage cancer reimbursement We strategically 1 pathway started with CRC as the first indication CRC Positive unit for Shield economics 3 to scale Clear patient preference for blood 4 101
Slide 102: Lack of screening compliance significantly impacts lives lost to colorectal cancer
Lack of screening compliance significantly impacts lives lost to colorectal cancer 50KColorectal cancer 76% of CRC deaths are in deaths per year1,2 individuals not up to date with screening3 1. Bibbins-Domingo K, et al; JAMA. 2016;315(23):2564-2575. 2. US Preventive Services Task Force. Screening fo
Slide 103: Smart Liquid Biopsy analyzes 1,000s of regions
2 High performance in detecting early- Smart Liquid stage cancer Broad Biopsy analyzes 1 reimbursement & access 1,000s of regions in cfDNA with leading sensitivity Positive unit 3 at low-cost economics to scale Patient preference 4 103
Slide 104: Shield is the first easy to use, highly accurate blood-based cancer screening test
Shield is the first easy to use, highly accurate blood- based cancer screening test with proven efficacy A new screening category in a pivotal trial 104
Slide 105: ECLIPSE trial demonstrated efficacy
ECLIPSE trial demonstrated efficacy 83% CRC Sensitivity 90% Specificity • 100% sensitivity stage II and stage III/IV • 81% CRC sensitivity at stage I – III • 55% sensitivity stage I • 13% advanced adenoma sensitivity Source: Chung, D., Gray, D. M., Greenson, J., Gupta, S., Eagle, C., Hu, S., Talasaz
Slide 106: Shield CRC performance is in range with other non-invasive guideline-recommended modalities
Shield CRC performance is in range with other non-invasive guideline-recommended modalities 74–92% 87–96% CRC sensitivity for current Specificity for current guideline-recommended guideline-recommended tests1,2 tests1,2 1. Imperiale, et al. 2014. NEJM; 2 Knudsen, et al. 2021. JAMA 106
Slide 107: Broad and equitable access is key to durable adoption and outcome improvements
2 High performance in detecting early- Broad and stage cancer Broad reimbursement equitable access 1 & access is key to durable adoption and outcome Positive unit economics 3 improvements to scale Patient preference 4 107
Slide 108: Reimbursement pathway for Multi-Cancer Shield starts with colorectal cancer indication
Reimbursement pathway for Multi-Cancer Shield starts with colorectal cancer indication Multi-Cancer … CRC 108
Slide 109: Reimbursement pathway for Shield starts with colorectal cancer indication
Reimbursement pathway for Shield starts with colorectal cancer indication CRC Clear pathway Medicare Coverage starting with Blood-based CRC screening NCD with 3-year interval CRC Private Coverage ACS and USPSTF guidelines Access National Coverage Determination ~120M individuals by CMS 109
Slide 110: USPSTF recommendations are based on the harms and benefits of each testing modality
USPSTF recommendations are based on the harms and benefits of each testing modality Lifetime Colonoscopies and Life-Years Gained Model Parameters Real-world longitudinal adherence model for simulated cohort Screening CRC One-Time Specificity2,3 Life-Years Gained per 1,000 individuals Interval1-3 Sen
Slide 111: Outcome model demonstrates that Shield has the highest averted rate of CRC deaths
Outcome model demonstrates that Shield has the highest averted rate of CRC deaths Lifetime Colonoscopies & CRC Deaths Averted Model parameters Real-world longitudinal adherence model for simulated cohort Screening CRC One-Time Specificity2,3 CRC death averted per 1,000 individuals 16 Interval1-3 Sen
Slide 112: Blazing a trail to the first FDA approved and reimbursed CRC screening test
Blazing a trail to the first FDA approved and reimbursed CRC screening test Published Launched ECLIPSE Filed PMA staging data Launch Shield Medicare & ACS USPSTF Shield LDT Readout with FDA at DDW IVD-CRC ADLT Status Guidelines Guidelines May 2022 4Q’ 22 1Q’ 23 2Q’ 23 2024 2026 CRC Drives ADLT Prici
Slide 113: People want a more pleasant and convenient cancer screening option
2 High performance in detecting early- stage cancer Broad People want a 1 reimbursement & access more pleasant and convenient cancer screening Positive unit 3 option economics to scale Patient preference 4 113
Slide 114: Successful screening requires both adherence and performance
120M Avg Risk Individuals Ages 45 – 851 Successful Adherence screening requires Colonoscopy FIT Cologuard both adherence 38% 2 43% 3 65% 4 and performance 70M 50M Screened Unscreened Individuals 5 Individuals 5 1. AACR Study, Cancer Prev Res (2020) 13 2. Singal AG, Gupta S, Skinner CS, et al. Effect
Slide 115: Shield addresses existing challenges to CRC screening
Shield addresses existing challenges to CRC screening Challenges in CRC screening1-3 Addressed by Shield Long Colonoscopy wait times Unpleasant experience Simple blood draw Time consuming, multi-step patient participation 1. US Preventive Services Task Force. JAMA. 2021;325(19):1965-1977 2. Muthukri
Slide 116: A new category of test will address the unmet need for patient preference
7 out of 10 Individuals who had a stool test would NOT choose stool again1 A new category of test will address the unmet need 5 to 1 for patient Unscreened individuals prefer blood over stool1 preference 90% Patient adherence to Shield LDT in >10K patients across >1,000 clinics2 1. 2022 Patient Segm
Slide 117: Blood-based screening is patient preferred and fits seamlessly into routine care
Screening eligible individuals regularly engage with healthcare providers Blood-based screening is Ages 50 - 64 Ages 65+ patient preferred and fits Doctors visit for any reason in the last 12 87% 95% seamlessly into months1 routine care Blood draw in the last 12 months2 85% 1.https://wwwn.cdc.gov/NH
Slide 118: Our technology, combined with a patient preferred modality, allows for a scalable business
2 High performance in detecting early- Our technology, stage cancer Broad reimbursement combined with a 1 & access patient preferred modality, allows for a scalable Positive unit economics 3 business to scale Patient preference 4 118
Slide 119: Favorable gross margin pathway enabled by Medicare ADLT pricing
Favorable gross margin pathway enabled by Medicare ADLT pricing $500 ASP $200 COGS One-year post-FDA approval, enabled by When processing 1 million samples per favorable ADLT pricing for Medicare year, enabled by Shield technology and beneficiaries high-throughput automation These numbers are approx
Slide 120: High adherence and patient preference drives ~40% increased S&M productivity
High adherence and patient preference drives ~40% increased S&M productivity Orders Placed 100 100 Adherence 65%1 90%2 Orders 65 90 Resulted 1. 4. EXACT Sciences presentation at Goldman Sachs 44th Annual Global Healthcare Conference, June 2023 2. Guardant data on file 120
Slide 121: Targeted commercial strategy for Shield launch in 2024
Targeted commercial strategy for Shield launch in 2024 High States with Strong utilization Phlebotomy concentration coverage of non-invasive access of Medicare mandates post screening lives ACS guidelines Maximize ASP Maximize efficiency & productivity *American Cancer Society (ACS) 121
Slide 122: Milestone-gated commercial roadmap to a blockbuster diagnostic brand
Milestone-gated commercial roadmap to a blockbuster diagnostic brand At scale 700 field team At USPSTF inclusion At FDA approval 300 field team 100-150 field team 122
Slide 123: Scalable commercial growth enables continuous improvement through data
2 Scalable High performance in detecting early- commercial stage cancer Broad growth enables 1 reimbursement & access continuous improvement through data, Positive unit 3 biobank, clinical economics to scale insights and real- Patient world evidence preference 4 123
Slide 124: Upgraded algorithm with demonstrated improved analytical sensitivity
Upgraded algorithm with demonstrated improved analytical sensitivity in detecting tumor signals Version 2 at ~2x lower levels 124
Slide 125: New data: Shield V2 clinical data
New data Shield V2 clinical data 125
Slide 126: Clinical sensitivity of Shield V2 in a U.S.-based colonoscopy-screened cohort
Clinical sensitivity of Shield V2 in a U.S.- based colonoscopy-screened cohort Prospective Study Results CRC Sensitivity Specificity Sensitivity in Stage I/II: N = 45 N = 1,458 V1: 76% (19/25) Shield CRC V1 – 84% 91% V2: 88% (22/25) PMA device (38/45) Shield 91% 91% Similar AA performance CRC V2 (41
Slide 127: Continuous improvement of Shield IVD
Continuous improvement of Shield IVD – best-in-class blood-based CRC screening Submit V2 supplemental PMA following approval of Shield* Potential for V2 approval in 2025 *Pending successful regulatory-grade data readout for V2. 127
Slide 128: Next step to Multi-Cancer is adding lung indication
Next step to Multi-Cancer is adding lung indication Multi-Cancer … CRC + Lung CRC 128
Slide 129: Same test. Simple software upgrades. Enables new cancer indications.
Same test. Simple software upgrades. Enables new cancer indications. 129
Slide 130: Reinventing screening for lung cancer with a simpler and accessible option
Reinventing screening for lung cancer with a simpler and accessible option 150K Lung cancer deaths 86% Of eligible individuals are 12M Unscreened per year, leading cause of unscreened1 individuals2 cancer-related death1 1. Jonas DE, Reuland DS, Reddy SM, et al. Screening for Lung Cancer With Low-Dos
Slide 131: On track to complete Shield-Lung enrollment in 2025
On track to Enrolling individuals who meet complete USPSTF Criteria for High-Risk Lung Cancer Shield-Lung Screening1 Negative for enrollment in lung cancer 2025 + One-year follow-up >7K Low- Lung cancer dose CT Currently enrolled First endpoint readout in 2026 1. Nguyen, et al. 2023. Screening for h
Slide 132: Prospective interventional multi-cancer detection study
Prospective interventional Enrolling multi-cancer 10,000 cancer-free individuals detection study … Diagnostic Evaluation Clinical 2H 2024 Cancer Not Confirmed Follow-up Expected first patient Cancer Confirmed enrollment 2-Year Clinical Follow-up 132
Slide 133: Blazing a trail to the first FDA approved and reimbursed Multi-Cancer test
Blazing a trail to the first FDA approved and reimbursed Multi-Cancer test Launched ECLIPSE Filed PMA Staging data Launch Shield Medicare & ACS USPSTF Shield LDT Readout with FDA at DDW IVD-CRC ADLT Status Guidelines Guidelines May 2022 4Q’ 22 1Q’ 23 2Q’ 23 2024 2026 CRC Drives NCD ADLT Pricing Stat
Slide 134: A once in a lifetime opportunity to reinvent cancer screening
A once in a lifetime opportunity to reinvent cancer screening 134134
Slide 135: Seeing deeper with epigenomics
Seeing deeper with epigenomics Dr. Justin Odegaard Vice President, Product Development
Slide 136: Dr. William Greenleaf
Research Focus Epigenomics Single-cell method development High-throughput biochemistry Bioinformatics for understanding gene regulation Dr. William Greenleaf Professor of Genetics, Stanford University
Slide 137: Dr. Jacob Berchuck
Research Focus Epigenetic cfDNA-based biomarkers for advanced cancer patients Epigenetic mechanisms of therapeutic response and resistance in Prostate Cancer Dr. Jacob Berchuck Assistant Professor of Medicine, Harvard Medical School
Slide 138: Dr. Simon Heeke
Research Focus Innovative biomarkers in lung cancer Liquid-biopsy assay development Data science Dr. Simon Heeke Assistant Professor, MD Anderson Cancer Center
Slide 139: Dr. Yuval Dor
Research Focus Diabetes and pancreatic cancer Epigenetic liquid biopsies DNA methylation clocks Dr. Yuval Dor Professor, The Hebrew University of Jerusalem
Slide 140: Today's panelists
Today’s panelists Dr. Will Greenleaf Dr. Jacob Burchuck Dr. Simon Heeke Dr. Yuval Dor Professor Assistant Professor Assistant Professor Professor 140
Slide 141: Balancing rapid revenue growth with financial discipline
Balancing rapid revenue growth with financial discipline Mike Bell Chief Financial Officer
Slide 142: Historical revenue growth fueled by core Therapy Selection business
Historical revenue growth fueled by core Therapy Selection business $450M Therapy Selection 49% Total Revenue $374M growth drivers CAGR $287M Reimbursement coverage $214M Regulatory approvals Clinical data $91M Commercial strength Biopharma partnerships Portfolio expansion 2018 2019 2020 2021 2022 1
Slide 143: Guardant360 has been the primary volume growth driver
125K 88K 50K 63K 44% Clinical Testing 29K Volume CAGR Guardant360 has been the primary 2018 2019 2020 2021 2022 volume growth driver 26K 21K 26% 19K 16K 10K Biopharma Testing Volume CAGR 2018 2019 2020 2021 2022 143
Slide 144: Strong revenue growth and major Therapy Selection tailwinds in 1H 2023
Strong revenue growth and major Therapy Selection tailwinds in 1H 2023 Recent Highlights $266M 30% Total Revenue Guardant360 CDx breast FDA approval $205M YoY Growth Guardant360 expanded reimbursement Guardant360 Japan reimbursement Response Medicare coverage EMR integrations 1H 2022 1H 2023 144
Slide 145: Therapy Selection has multiple growth drivers well beyond 2023
Therapy Selection has multiple growth drivers well beyond 2023 / Portfolio ASP Market expansion increases Future Guardant360 Infinity offering to CDx approvals biopharma partners TissueNext & International expansion, Response attachment e.g., Japan, UK, China 145
Slide 146: Leveraging existing infrastructure will enable Therapy Selection profitability
Leveraging existing infrastructure will enable Therapy Selection profitability Commercial Regulatory Operations • 380+ oncology commercial team • Proven IVD and reimbursement expertise • Scaled logistical and operational backbone • 160+ biopharma partnerships • Robust, well-established quality syste
Slide 147: FY 2023 financial targets focused on revenue growth and financial discipline
FY 2023 financial targets focused on revenue growth and financial discipline Revenue OpEx Free Cash Flow $545 – $550M < FY 2022 ~($350M) 21% - 22% y/y Leveraging existing Reducing cash growth infrastructure burn 147 Guidance issued on Q2 2023 earnings call August, 3, 2023. Free cash outflow is defin
Slide 148: Focus on Reveal reimbursement to increase ASP and accelerate volumes
Focus on Reveal reimbursement to increase ASP and accelerate volumes Highly efficient MRD Business Model leveraging existing Therapy Selection infrastructure Incremental ASP 2028 from CRC ASP surveillance, lung, breast, etc. Commercial Operations Medical Affairs Volume 2023 ASP Development Internati
Slide 149: 5-year financial targets for Therapy Selection & MRD
5-year financial targets for Therapy Selection & MRD Revenue Growth Clinical ASPs by 2028 Gross Margins • >20% Combined Therapy Selection & • G360 > $3,000 • 60-70% Combined Therapy Selection & MRD revenue CAGR MRD gross margin • Tissue > $2,000 (Total revenue excluding Screening) (Gross margin excl
Slide 150: Shield is poised to be a blockbuster diagnostic brand
Shield is poised to be a blockbuster diagnostic brand 2028 2026 >1M tests >$500M revenue 2024 USPSTF Guidelines FDA approval Medicare reimbursement Highly efficient S&M spend Significant economies of scale as volume grows 150
Slide 151: Balancing rapid Shield growth with measured spend over next 5 years
Balancing rapid Shield growth with measured spend over next 5 years Annual cash burn ~$200M over 5 years ASP > $500 Gross Margins CapEx • Medicare ADLT rate • Positive 1 year post launch • Low cost, high volume, automated lab • Incremental private payer coverage • ~60% at 1M annual volume operations
Slide 152: 5-year total revenue targets
5-year total revenue targets >30% >$2B 5 Year CAGR In 2028 152
Slide 153: Current cash provides runway to reach cash flow breakeven
YE Cash Cash Flow >$1B Breakeven 2023 2024 2025 2026 2027 2028 Current cash provides runway to reach cash flow breakeven <$(350m) Five Year Total Cash Burn <$1B • Therapy Selection breakeven end of 2023 • Combined Therapy Selection + MRD generates positive cash flow over cumulative 5-year period • S
Slide 154: Key financial targets
Grow profitable Therapy Selection business Expand MRD reimbursement to increase ASP and accelerate volumes Key financial Balance rapid Screening revenue growth targets with measured spend Achieve >30% total revenue 5-year CAGR and >$2B in 2028 Reach cash flow breakeven by end of 2028 154
Slide 155: The future of transforming cancer care and beyond…
The future of transforming cancer care and beyond… Helmy Eltoukhy, PhD AmirAli Talasaz, PhD co-Chief Executive Officer & Chair co-Chief Executive Officer & co-Founder
Slide 156: Cancer is not a linear journey
Cancer is not a linear journey Screening Our ecosystem of tests will MRD synergistically work together Therapy Selection 156
Slide 157: Biologically rich data
Biologically rich data Mutations Chromosomal rearrangements Copy number aberrations Comprehensive longitudinal Methylation characterization of tumor, whole body epigenomic profiles DNA fragment lengths and immune response Read depth coverage (tumor) Gene expression Virus sequences detection Figure f
Slide 158: The power of genomic and epigenomic data
The power of of commercial samples genomic and >90% are linked to associated medical claims data1 epigenomic data is amplified by connections to Comorbidities Disease progression real-world Lines of therapy Time to next treatment evidence Treatment history Treatment discontinuation Survival 1. Guard
Slide 159: Real-world evidence from GuardantINFORM
Real-World Analysis Shows Utility of ctDNA Kinetics in Real-world Patients With Advanced Colorectal Cancer evidence from GuardantINFORM has been successfully used to validate novel signatures A B Kaplan-Meier in molecular responders vs non-responders for patients receiving chemotherapy +/- VEGF. Kas
Slide 160: Data generation at scale
Data generation Expecting to at scale sequence millions of clinical Single Platform samples per year across Scalable average risk population and Cost-Efficient patients impacted by Configurable cancer 160
Slide 161: Data growth powering research
Data growth powering research 300 250 18-month Data Volume (PB) 200 doubling rate 150 Guardant data growth is 100 comparable to that of the largest NIH archive of genomic data 50 NIH Archive Largest consumer DB 0 2020 2012 2022 2023 2024 2025 2026 2027 2028 Source: NIH Archive and Guardant Health da
Slide 162: Almost every disease has a visible fingerprint through epigenomics
Almost every disease has a visible fingerprint when viewed through the lens of epigenomics Neurodegenerative Disease Cardiovascular Disease Rheumatoid Arthritis Inflammatory Bowel Disease https://www.sciencedirect.com/science/article/abs/pii/S1471489213000118 https://www.nature.com/articles/s41392-0
Slide 163: Our technology platform can be leveraged across multiple diseases beyond cancer
ing and Therapy Selectio n n cree S Cancer Our technology platform and Ca y tor rd commercial ma iov Inflam asc infrastructure can be ular leveraged across multiple diseases beyond cancer and will reshape precision medicine The promise of precision medicine will be accessed through a single comprehe
Slide 164: Our continued success will expand our mission over time
Our continued success will expand our mission over time from one of conquering cancer to that of guarding wellness 164
Slide 165: Investor Day 2023
INVESTOR |20 DAY |23 © GUARDANT