Guardant Health, Inc. · NASDAQ:GH
Guardant Health — Q2 2024 Earnings Presentation
24 slides from Guardant Health's earnings presentation, Aug 7, 2024
Slide 1: Transforming Cancer Care
Transforming Cancer Care Q2 2024 Earnings Call August 7, 2024
Slide 2: 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 projections are reasonable, such forward-looking statements are only predictions and involve known and statements within the meaning of federal securities laws. These
Slide 3: FDA approved for first-line CRC screening
FDA approved for first-line CRC screening Intended Use The Shield test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Meets the requirements Shield is intended for colorec
Slide 4: Strong clinical evidence supports the value of Shield
Strong clinical evidence supports the value of Shield CAN-SCREEN Health outcome model confirms the public health importance of blood-based testing Publication of ECLIPSE1 validates strength of clinical data Considers both clinical efficacy and longitudinal adherence in determining CRC incidence and
Slide 5: Shield raises the bar for blood-based CRC screening tests
Shield raises the bar for blood-based CRC screening tests FDA approval for first line indication New performance bar: 83% sensitivity, 90% specificity 10 years of R&D and learnings from being liquid biopsy leader 3-year 20,000 patient ECLIPSE study Publication in top journal (NEJM) Rigorous >1 year
Slide 6: Finally, a colon cancer screening option to get excited about
Finally, a colon cancer screening option to get excited about… Now Commercially Available in U.S. Visit ShieldCancerScreen.com for more information 6
Slide 7: With Medicare coverage, Shield addresses one of the largest diagnostics opportunities
With Medicare coverage, Shield already addresses one of the largest ever diagnostics opportunities 45M 15M Lives covered by Medicare 2 Annual testing opportunity with Medicare coverage alone 2 120M Average-risk individuals Age 45 – 841 7 1. https://wwwn.cdc.gov/NHISDataQueryTool/SHS_adult/index.html
Slide 8: Patient preference for blood testing can significantly improve CRC screening compliance
Patient preference for blood testing can significantly improve CRC screening compliance Patient preference Ease-of-use 7/10 Individuals who had a stool test would NOT choose stool again1 87% Patients >50 years old that visited doctor in the last 12 months2 5:1 Unscreened individuals prefer blood ove
Slide 9: CMS is proactively removing barriers to patient adoption of blood-based screening tests
CMS is proactively removing barriers to patient adoption of blood-based screening tests • "We consider that some patients may Expanded coverage for follow-up consider a blood test less uncomfortable than administering a stool-based test, colonoscopy following positive especially if the blood draw is
Slide 10: Achieved 2024 key milestones for Shield
Achieved 2024 key milestones for Shield 2024 2025 2026 • ECLIPSE Journal • Multi-cancer Data • USPSTF Guidelines Publication • ADLT Status • Expanded Market • Advisory Panel Opportunity • Improved Medicare • FDA Approval Pricing • Medicare Coverage • ACS Guidelines • Shield IVD Launch • Positive Gro
Slide 11: Transforming patient lives across the continuum of cancer care
Transforming patient lives across the continuum of cancer care Screening Minimal Residual Disease Therapy Selection Early Disease Detection Recurrence Detection & Surveillance Advanced Cancer Care Cancer Surgery Detection Recurrence +/- Adjuvant 1st Line Tx 2nd Line Tx +Tx FDA Approved FDA Approved
Slide 12: Strong topline growth driven by precision oncology revenue
Strong topline growth driven by precision oncology revenue Total Revenue 29% Precision Oncology Revenue 33% $177M YoY Growth $167M YoY Growth $137M $125M Q2 2023 Q2 2024 Q2 2023 Q2 2024 12
Slide 13: Record clinical and biopharma volumes
Record clinical and biopharma volumes Clinical Volume 14% YoY Growth Biopharma Volume 10,475 56% YoY Growth 49,400 43,500 6,700 Q2 2023 Q2 2024 Q2 2023 Q2 2024 13
Slide 14: Launched major upgrade of Guardant360 LDT on Smart Liquid Biopsy platform
Launched major upgrade of Guardant360 LDT on Smart Liquid Biopsy platform 10x 10x First-of-its-kind (liquid or tissue) CGP test with Epigenomics Ability to identify more patients for existing targeted therapies and immunotherapies undetectable by current CGP tests Larger panel Sensitivity improvemen
Slide 15: Upgraded TissueNext to identify more treatment options for patients
Upgraded TissueNext to identify more treatment options for patients with advanced cancer Expanded panel of 498 clinically Best-in-class turnaround time relevant actionable biomarkers Covered by Medicare for Only tissue CGP panel with an AI-powered all advanced solid tumors scoring algorithm that imp
Slide 16: Publication of data from COSMOS supports Reveal CRC surveillance reimbursement
Publication of data from COSMOS supports Reveal CRC surveillance reimbursement Publication in Clinical Cancer Research validates Reveal for MRD testing Submitted to MolDx for Medicare reimbursement 1,900 longitudinal surveillance samples from 342 patients 100% of patients underwent evaluation withou
Slide 17: Deep Reveal clinical data pipeline supporting additional reimbursement
Deep Reveal clinical data pipeline supporting efforts for additional reimbursement 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 TRACC P
Slide 18: Key near-term inflection opportunities for MRD in 2025
Key near-term inflection opportunities for MRD in 2025 CRC surveillance COGS Volume reimbursement reduction acceleration ASP Gross margin Cash burn improvement inflection point reduction 18
Slide 19: Q2 2024 GAAP financials
Q2 2024 GAAP financials Q2’24 Q2’23 Total Revenue $177.2M $137.2M Precision Oncology $166.5M $125.2M Development Services & Other $10.7M $11.9M Gross Margin 59% 61% Operating Expenses $205.4M $202.9M Loss from Operations $(100.6M) $(119.6M) Net Loss $(102.6M) $(72.8M) EPS $(0.84) $(0.67) 19 Gross ma
Slide 20: Guardant360 ASP benefiting from multiple tailwinds
Guardant360 ASP benefiting from multiple tailwinds Guardant360 ASP $2,950-$3,000 Guardant360 LDT Medicare $2,900-$2,950 reimbursement increased to $5,000 effective January 1, 2024 ~$2,750 Continued ASP tailwinds due to improved ~$2,700 Medicare Advantage and commercial ~$2,650 reimbursement 2H 2024
Slide 21: Q2 2024 non-GAAP financial measures
Q2 2024 non-GAAP financial measures Non-GAAP Measure Q2’24 Q2’23 Gross Margin 60% 62% Gross Margin excluding Screening 62% 64% Operating Expenses $178.8M $180.5M Net Loss $(58.5M) $(88.7M) EPS $(0.48) $(0.82) Adjusted EBITDA $(61.9M) $(85.2M) Free cash flow $(99.1M) $(100.5M) June 30, 2024 Dec 31, 2
Slide 22: Increasing full year 2024 revenue guidance
Increasing full year 2024 revenue guidance Revenue Non-GAAP Gross Margin (excluding Screening) (excluding Screening) $690M – $700M 61% – 63% 22% - 24% y/y growth Raised from previous expectations of $675M – $685M Non-GAAP Operating Expenses Free Cash Flow $720M – $730M $(275M) – $(285M) 1% y/y decre
Slide 23: 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 24: Guardant Health
() GUARDANT