Biodesix, Inc. · NASDAQ:BDSX
Biodesix — Investor Presentation (January 2021)
50 slides from Biodesix's investor presentation, Jan 8, 2021
Slide 1: Corporate Presentation
JANUARY 2021 Corporate Presentation Exhibit 99.2
Slide 2: Disclaimer and forward-looking statements
This presentation and the accompanying oral presentation have been prepared by Biodesix, Inc. ("Biodesix", “we” or the "Company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or represen
Slide 3: Introductions: presenting today
Robin Harper Cowie Chief Financial Officer Scott Hutton President & Chief Executive Officer Director of Payor & Government Relations Manager of Business Development Planning & Analysis SVP & General Manager of the Vascular Intervention division Former Laboratory Manager, Researcher Presenting today
Slide 4: Mission: trusted partner for data-driven diagnostic solutions in lung disease
We strive to be a trusted partner that the world relies on for data-driven diagnostic solutions in lung disease by improving overall patient outcomes and lowering the overall healthcare cost by reducing the use of ineffective and unnecessary treatments and procedures.
Slide 5: We are a data-driven diagnostic solutions company
140K+ sample & data biobank We are a data-driven diagnostic solutions company Company Overview Experienced Leadership Team & Commercial Infrastructure Technology Agnostic Approach to Precision Medicine 6 lung focused diagnostic tests 245K+ tests performed 50+ biopharma customers $29B+ total US marke
Slide 6: We have diagnostic tests for lung disease
We have 6 diagnostic tests for lung disease Our Portfolio RESPIRATORY VIRUSES LUNG NODULES LUNG CANCER Tumor genetic profile – actionable tumor mutations Patients' immune response to cancer Identify likely benign nodules Identify likely malignant nodules Hospital Systems, Employers, Universities, St
Slide 7: $27B+ annual U.S. lung cancer testing market opportunity
$27B+ annual U.S. lung cancer testing market opportunity Lung Cancer Continuum of Care #1 deadliest cancer with more deaths annually than the next three deadliest cancers combined (colorectal, pancreas, and breast)
Slide 8: Identifying clinical unmet needs in patient care
Identifying clinical unmet needs in patient care Lung Cancer Continuum of Care LUNG NODULE RISK ASSESSMENT pulmonologist CONFIRM DIAGNOSIS pulmonologist, thoracic surgeon TREATMENT DECISIONS medical oncologist thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION medical oncologist t
Slide 9: Understanding lung nodule management
Understanding lung nodule management CT Surveillance Diagnosis solitary pulmonary nodule risk calculator (≤65% risk) Very Low Risk (<5%) Low to Moderate Risk (5-65%) High Risk (>65%) 79.6% 9.5% 10.9% Physician Judgement identifies likely malignant nodules with test results in one day identifies like
Slide 10: Blood-based nodule risk assessment: Nodify Lung
Full commercial launch March 2020 Full commercial launch October 2019 Medicare coverage with a unique CPT code & ADLT status ($3,520) Beginning efforts with payers 4 to 5-day turnaround time Two studies ongoing (ORACLE & ALTITUDE) for combined lung nodule risk assessment and combined 26 peer-reviewe
Slide 11: Advancing our clinical data package
We are committed to advancing our clinical data package Diagnosis ALTITUDE Clinical Utility Study ORACLE Registry Study First-in-class biomarker study for the early detection of lung cancer Multicenter, randomized controlled, prospective clinical utility study Initiated December 2020 Principal Inves
Slide 12: Treatment guidance & monitoring
Treatment Guidance & Monitoring Patients need to be given the right treatment as fast as possible tissue blood or Tumor Profile Immune Profile 4M+ molecular testing opportunities to guide NSCLC treatment decisions
Slide 13: Blood-based tumor & immune profiling
VeriStrat Good (2x median survival) vs. VeriStrat Poor Mutations detected by ddPCR from blood DNA: EGFR | BRAF | KRAS RNA: EML4-ALK | ROS-1 | RET Medicare and private payer coverage Not restricted by stage of NSCLC or multiple tests per patient per cancer Medicare and private payer coverage with a u
Slide 14: Informing initial treatment decisions with quick, actionable results
DIAGNOSIS TREATMENT MONITORING Blood Tumor & Immune Monitoring Blood Blood CONFIRM DIAGNOSIS pulmonologist, thoracic surgeon TREATMENT DECISIONS medical oncologist DISEASE PROGRESSION medical oncologist Blood 9 days Results Liquid Biopsy NGS Tissue-Based NGS Tissue 26 days Results Informing initial
Slide 15: Our response to the COVID-19 pandemic
Our response to the COVID-19 pandemic Cancer Can’t Wait helps prioritize patients for diagnostic intervention with suspicious lung nodules helps inform treatment options and timing following a new lung cancer diagnosis supporting the pandemic with COVID-19 testing They asked, we responded. We are a
Slide 16: SARS-CoV-2 ddPCR and Total Ab tests
Bio-Rad SARS-CoV-2 ddPCR Test Bio-Rad Platelia SARS-CoV-2 Total Ab Test 100% concordance with CDC assay in symptomatic individuals Molecular test detected by ddPCR SARS-CoV-2 N gene (N1 & N2) | human Rpp30 gene Self-collect mid-nasal swab 98% sensitivity & 99% specificity >8 days post onset of sympt
Slide 17: Diagnostics in development
We are committed to answering critical clinical questions in lung cancer Diagnostics in Development Risk of Recurrence (ROR) Test Primary Immune Response (PIR) Test We discovered a host immune profiling signature that can help identify stage 1 NSCLC patients' pre-surgery who are at a higher risk of
Slide 18: Biopharma Services
Biopharma Services Driving near-term & long-term value creation and ongoing revenue 50+companies 140,000+ sample & data biobank Significant experience to date working with biopharma customers Select publicly-disclosed biopharma customers
Slide 19: Our 2020 accomplishments
Our 2020 accomplishments Reflection PRODUCTS & SERVICES COLLABORATIONS DATA & STUDIES Streck Merck KGaA & Pfizer Bio-Rad ALCMI Colorado State University Big Ten Conference State of Colorado Purdue University Nodify CDT test launch Biodesix WorkSafe ddPCR test launch Ab test launch Biodesix Blood Col
Slide 20: Our 2020 performance & long-term growth plan
Our 2020 performance & long-term growth plan ($, in millions) Financial Overview *These are not projections; they are goals and are forward-looking, subject to significant business, economic, regulatory and competitive uncertainties and contingencies, many of which are beyond the control of Biodesix
Slide 21: Appendix
W biodesix: Appendix
Slide 22: We derive our revenue from two sources
We derive our revenue from two sources Our Business Model DATA-DRIVEN DIAGNOSTIC SOLUTIONS LUNG FOCUSED DIAGNOSTIC TESTING BIOPHARMA SERVICES DIAGNOSTIC DISCOVERY, DEVELOPMENT & TESTING Technology agnostic approach to solving clinical diagnostic challenges leveraging our proprietary artificial intel
Slide 23: Unique in our approach to precision medicine
Unique in our approach to precision medicine Our Platform 140,000+
Slide 24: Uncovering the depth and breadth of disease biology from blood
Uncovering the depth and breadth of disease biology from blood Our Platform DIAGNOSTIC CORTEX® ARTIFICIAL INTELLIGENCE PLATFORM Biomarkers Genomics (DNA, RNA) Radiomics Our Technologies Droplet Digital PCR Next Generation Sequencing Biomarkers Proteomics Post-Translational Modifications Our Technolo
Slide 25: Understanding standard of care
Understanding standard of care Lung Cancer Continuum of Care LUNG NODULE RISK ASSESSMENT pulmonologist CONFIRM DIAGNOSIS pulmonologist, thoracic surgeon TREATMENT DECISIONS medical oncologist thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION medical oncologist thoracic surgeon MO
Slide 26: Our portfolio of blood-based diagnostic tests
Our portfolio of 4 blood-based diagnostic tests Lung Cancer Continuum of Care LUNG NODULE RISK ASSESSMENT pulmonologist CONFIRM DIAGNOSIS pulmonologist, thoracic surgeon TREATMENT DECISIONS medical oncologist thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION medical oncologist th
Slide 27: Case Study: Catching curable cancer with faster intervention
Case Study: Catching curable cancer with faster intervention Diagnosis PATIENT’S CLINICAL CHART PRE-TEST DECISION POST-NODIFY OUTCOME At the estimated pre-test risk of 39%, the patient was not comfortable with any invasive diagnostic procedures but was willing to undergo a blood draw for Nodify Lung
Slide 28: Case Study: Changing lung cancer patient's treatment plan
Case Study: Changing lung cancer patient’s treatment plan Treatment Guidance & Monitoring PATIENT’S CLINICAL CHART Scans revealed multiple metastases (including brain). Staging confirmed stage IV adenocarcinoma. Former smoker (quit 1-year ago) 55-year old female presented to the clinic with a persis
Slide 29: Where our peer-products fit along the patient treatment pathway
Where our peer-products fit along the patient treatment pathway Lung Cancer Continuum of Care LUNG NODULE RISK ASSESSMENT pulmonologist CONFIRM DIAGNOSIS pulmonologist, thoracic surgeon TREATMENT DECISIONS medical oncologist thoracic surgeon DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION medic
Slide 30: Our testing strategies fit together in a simple portfolio
Our testing strategies fit together in a simple portfolio Lung Cancer Continuum of Care CT surveillance or standard of care Low to Moderate (≤65%) risk of malignancy High (>65%) risk of malignancy LUNG NODULE IDENTIFIED LUNG CANCER DIAGNOSIS Nodule Risk Assessment Tumor & Immune Profiling Biopsy, su
Slide 31: Multifaceted strategy to drive Nodify Lung adoption
We employ a multifaceted strategy to drive Nodify Lung adoption Our Commercial Strategy & Key Successes CORPORATE PARTNERSHIPS NATIONAL SALES TEAM MARKETING & MEDICAL AFFAIRS LARGE U.S. HEALTHCARE SYSTEMS HEALTH GROUPS PATIENT ADVOCACY GROUPS Direct sales to lung-focused physicians E-MARKETING & ADV
Slide 32: Our lung-focused sales force distributed across the U.S.
Our lung-focused sales force distributed across the U.S. Our Commercial Strategy 2020 year-end 2022 year-end* *Represents our objectives for 2022 based on current plans. Actual sales force distribution across geographies in the United States may differ as we reassess our plans.
Slide 33: Our team, capabilities and partnerships enable speed and agility
Our team, capabilities and partnerships enable our speed and agility COVID-19 Testing Program MAR 13 Biodesix Remote Work Initiated for Non-Laboratory Personnel 2.5 weeks from agreement to launch APR MAY 1 JUN JUL BIODESIX LAUNCH Bio-Rad SARS-CoV-2 ddPCR Test FDA EUA Bio-Rad SARS-CoV-2 ddPCR Test FD
Slide 34: $2B+ annual biopharma biomarker testing & CDx market opportunity
$2B+ annual biopharma biomarker testing & CDx market opportunity Biopharma Services 1. LEK and PMC 2019. The evolution of biomarker use in clinical trials for cancer treatments. 2. Wong CH et al. Biostatistics, Volume 20, Issue 2, April 2019, Pages 273–286 The use of biomarker testing in clinical tr
Slide 35: End-to-end diagnostic solutions for biopharma customers
We provide end-to-end diagnostic solutions for biopharma customers Biopharma Services Discovery Commercialization Development Data-driven Diagnostic Solutions Technology Agnostic Approach Proprietary AI Platform Tumor & Host/Immune Profiling Multi-Omic & Single-Omic Biomarker Discovery & Feasibility
Slide 36: Our suite of diagnostic testing solutions for biopharma customers
Our suite of diagnostic testing solutions for biopharma customers GeneStrat 52 pan-Cancer cf Assay Lung cfTNA Assay (12 genes) Lung cfDNA Assay (11 genes) Breast cfDNA Assay v2 (12 genes) Breast cfDNA Assay (10 genes) Colon cfDNA Assay (14 genes) Myeloid Assay (40 DNA genes + 29 fusions) Tumor Mutat
Slide 37: ORACLE Registry Study
Title: ORACLE - An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test. Status: The first patient enrolled on October 16, 2018. As of May 1, 2020, 423 patients have been enrolled and are undergoing primary endpoint analysis, with 2-year follow-up estimated to be completed
Slide 38: ALTITUDE randomized controlled trial
Title: ALTITUDE - Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules. Status: Received central investigational review board (IRB) approval in December 2019 and have an e
Slide 39: INSIGHT observational study
Title: An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer (INSIGHT) Status: The first patient enrolled was on May 11, 2016. To date, we have over 3,500 patients enrolled with a target 5,000 enrollmen
Slide 40: Beacon-Lung Clinical Study
Beacon-Lung Clinical Study (NCT04676386) Treatment Guidance & Monitoring Primary Immune Response Test Title: A Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With An Immune Checkpoint Inhibitor (ICI) With or Without Platinum-Based Chemotherapy Status: This study will be carried o
Slide 41: Significant growth potential as we expand into lung disease
Significant growth potential as we expand into lung disease Future Markets Acute respiratory distress syndrome (ARDS)
Slide 42: Biodesix WorkSafe testing partnerships & testimonials
Biodesix WorkSafe Testing Partnerships & Testimonials COVID-19 Testing Biodesix to Provide COVID-19 Testing for Colorado State University Campus August 12, 2020 Biodesix Partners with Boulder Community Health to Expand Access to COVID-19 Testing May 20, 2020 Major League Lacrosse Partners with Biode
Slide 43: We have two certified, high-complexity laboratories
We have two certified, high-complexity laboratories Appendix CAP-accredited CLIA-certified NYS CLEP certified: Soluble Tumor Markers, Molecular & Cellular Tumor Markers and Virology ISO 13485-certified FDA Emergency Use Authorization COLA-accredited NYS CLEP certified: Soluble Tumor Markers & Diagno
Slide 44: Pre-analytic specimen collection solutions
Pre-analytic specimen collection solutions Laboratory & Business Operations We have enabled ambient shipping (‘no cold chain’) with specimen preservation for our diagnostic tests
Slide 45: Our patented Biodesix Blood Collection Device
Our patented Biodesix Blood Collection Device (BCD) Laboratory & Business Operations Whole Blood Transport & Plasma Separation Device Combines multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping. Specimen detection has been demonst
Slide 46: Intellectual property portfolio
Intellectual property portfolio Appendix 84 issued patents 49 in the US and 35 foreign; 16 U.S. and 23 foreign applications still in various stages of prosecution 33 registered trademark numbers across 12 countries Patent Subject Matter: VeriStrat and Nodify tests and their uses in non-small cell lu
Slide 47: Multiple levers for growth
Multiple levers for growth Our Strategy Drive Increased Awareness, Adoption, and Reimbursement of Our Diagnostic Tests Deepen Relationships with Current and New Biopharma Customers Further Demonstrate Clinical Utility and Economic Benefits Introduce New Diagnostic Tests in Lung Disease Enhance Propr
Slide 48: Our Leadership Team
Extensive knowledge in diagnostics & reimbursement Our Leadership Team Scott Hutton CEO Robin Harper Cowie CFO Kieran O’Kane CCO Gary Pestano CDO (PhD) Robert Georgantas SVP Research (PhD) Paul Beresford CBO (PhD) Bobbi Coffin CGO James Jett CMO (MD) Steven Springmeyer CMO (MD) Linda Traylor VP CDMA
Slide 49: A Board of Directors with a vast amount of industry expertise
A Board of Directors with a vast amount of industry expertise Appendix Birchview Capital Crabtree Partners LLC
Slide 50: W biodesix:
W biodesix: