Full Press Release Details
Third Quarter 2021 Corporate Presentation Exhibit 99.1
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 representation by the presenter or Biodesix or any officer, director, employee, agent or advisor of Biodesix. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. Information provided in this presentation and the accompanying oral presentation speak only as of the date hereof.
Certain information contained in this presentation relates to, or is based on, studies, publications, surveys and other data obtained from third-party sources and Biodesix's own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.
This presentation contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "should," "will" or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, factors, and assumptions, including among other things, the dependence of the commercial success of our current and future diagnostic tests and services on attaining significant market acceptance, difficulties we may experience in managing our growth, our failure to retain sales and marketing personnel and marketing capabilities or to develop broad awareness of our diagnostic tests, our failure to maintain our current relationships, or enter into new relationships, with biopharmaceutical companies, the demand for, and increased adoption of, our diagnostic tests, including our COVID-19 tests, being lower than we anticipate, our dependence on third-party suppliers, competition in our industry and specifically in the diagnostic tests space, our failure to offer high-quality support for our diagnostic tests and services which may adversely affect our relationships with providers and negatively impact our reputation among patients and providers. In addition, new risks may emerge from time to time, and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation or to conform these statements to actual results or to changes in our expectations.
This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Disclaimer
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 Introductions Chief Operating Officer VP of Finance
VP of Reimbursement & Health Economics
Senior Director and Director of Reimbursement 20+ years of industry experience with expertise in Leadership | Mergers & Acquisitions | Sales & Marketing VP & General Manager of Neurosurgery
VP & Business Leader of Surgical Navigation
and Intra-Operative Imaging 15+ years of industry experience with expertise in Finance | Reimbursement | Operational Excellence
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.
We have 7 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, State of Colorado Pulmonologists, Hospital Systems Pulmonologists, Thoracic Surgeons, Medical Oncologists cPass SARS-CoV-2 Neutralization Antibody Test Total Antibody Test* MOLECULAR
viral RNA detection SEROLOGY
antibodies Commercialized in partnership with Bio-Rad Laboratories ddPCR Test DETECTION
of SARS-CoV-2 neutralizing antibodies
Identifying clinical unmet needs in patient care Lung Cancer Continuum of Care LUNG NODULE
pulmonologists CONFIRM DIAGNOSIS
thoracic surgeons TREATMENT DECISIONS
medical oncologists,
thoracic surgeons DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologists,
thoracic surgeons MONITORING 62% of biopsies are on benign nodules 35% of surgeries are on benign nodules 17% of patients sent to CT surveillance have cancer How can we improve the risk assessment of suspicious lung nodules? 30-50%
of patients have insufficient tissue for molecular testing How can we ensure the right patient gets the right treatment quickly? 9 -day testing turnaround time is too long to wait for treatment decisions How can we identify disease progression earlier? 20-40%
of stage I NSCLC patients recur after curative-intent surgery Lung cancer kills more people annually in the US than the next three cancers combined (Colorectal, Breast, Prostate)
Understanding lung nodule management CT Surveillance ? What Next? Diagnosis physician judgement risk calculators Very Low Risk
(<5%) Low to Moderate Risk
(>65%) 79.6% 9.5% 10.9% *USPSTF recently published a final recommendation statement to expand the eligible population for lung cancer screening (March 9, 2021). The recommendation expands the age range to 50 to 80 years (previously 55 to 80 years) and reduced the pack-year history to 20 pack-years of smoking (previously 30 pack-years).
Full commercial launch March 2020 Full commercial launch October 2019 Medicare coverage with a unique CPT code & ADLT status ($3,520) Efforts ongoing with payers 4-day turnaround time Two studies ongoing (ALTITUDE & ORACLE) for combined lung nodule risk assessment and over 35 peer-reviewed publications & abstracts Identifies patients with lung nodules that are likely malignant 24-hour turnaround time Autoantibodies on an ELISA platform from blood
P53 | CAGE | NY-ESO-1|GBU4-5 | MAGE A4 | SOX2 | HuD 78% PPV, 98% specificity & 28% sensitivity Identifies patients with lung nodules that are likely benign Proteins on an LC-MS platform from blood (BCD)
Proteins: LG3BP | C163A
Clinical Profile: Age | Smoking History | Cancer History
Radiologic Profile: Nodule Size | Location | Spiculation 98% NPV, 97% sensitivity & 44% specificity Blood-Based Nodule Risk Assessment
Reclassifying risk to help reduce uncertainty in lung nodule management CT Surveillance Diagnosis solitary pulmonary nodule risk calculator
( 65% risk) Very Low Risk
(<5%) Low to Moderate Risk
(>65%) 79.6% 9.5% 10.9% Physician Judgement identifies likely malignant nodules with test results in one day identifies likely benign nodules with test results in one week
Treatment Guidance & Monitoring Patients need to be given the right treatment as fast as possible tissue blood or Tumor
molecular testing opportunities to guide NSCLC treatment decisions In the NCCN Guidelines NSCLC v.1 2018, there were 34 treatment regimens (4 immunotherapies*, 9 targeted therapies, 21 chemotherapies)
** On March 4, 2015, the first immunotherapy (nivolumab) was approved to treat patients with NSCLC
VeriStrat Good (2x median survival) vs. VeriStrat Poor Mutations detected by ddPCR from blood
DNA (SNV/Indels): BRAF | EGFR | KRAS
RNA (Fusions): ALK | RET | ROS-1 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 unique CPT code & ADLT status ($2,871) 85+ publications & abstracts 30+ publications & abstracts Greater than 4,000+ patients enrolled in INSIGHT1 registry study Less than 36-hour turnaround time Less than 36-hour turnaround time Identifies blood-based, guideline recommended NSCLC tumor mutations 91% sensitivity & 100% specificity Blood-based test identifies a chronic inflammatory disease state associated with aggressive cancer Proprietary proteomic signature identified from blood (BCD) by MALDI-ToF Mass Spectrometry & AI Blood-Based Tumor & Immune Profiling 1 https://clinicaltrials.gov/ct2/show/NCT03289780
Where our peer-products fit along the patient treatment pathway Lung Cancer Continuum of Care LUNG NODULE
pulmonologists CONFIRM DIAGNOSIS
thoracic surgeons TREATMENT DECISIONS
medical oncologists,
thoracic surgeons DIAGNOSIS TREATMENT DISEASE RECURRENCE & PROGRESSION
medical oncologists,
thoracic surgeons MONITORING imaging (CT & PET) biopsy surgery Percepta
(Veracyte) Nasal Brushing Classifier
-earliest anticipated launch 2H 2021
-claims non-invasive'
-population limited to current or former smokers
-uncertain turnaround time DetermaDx
failed in validation Guardant360 CDx
(Guardant Health) FoundationOne Liquid CDx
(Foundation Medicine) FoundationOne CDx
(Foundation Medicine) Imaging
(CT & PET) symptoms NGS test
Next Generation Sequencing (NGS) 52-Gene Test
Fastest test with 72-hour Turn-around time vs. 7-14 days, for guideline relevant mutations
Synergies with existing GeneStrat ddPCR 6-gene test and VeriStrat tests
Launch now expected first quarter of 2022
Risk of Recurrence Test (RoR)
Host immune profiling signature that identifies stage 1 NSCLC patients pre-surgery who are a higher risk of recurrence (ROR) and may benefit from adjuvant chemotherapy
Anticipated launch 2023
Primary Immunotherapy Response (PIR) Test
Test for selecting treatment na ve NSCLC patients for immune checkpoint inhibitor regimens independent of, and complementary to PD-L1 status
Anticipated launch 2023
Pipeline Products Treatment Guidance & Monitoring
Biopharma Services Driving near-term & long-term value creation and ongoing revenue 50+companies 150,000+ sample & data biobank Significant experience to date working with biopharma customers Select publicly-disclosed
Our suite of diagnostic testing solutions for biopharma customers GeneStrat NGS (52 genes)
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 Mutation Burden (TMB)
Comprehensive Assay Plus (500+ genes, TMB, MSI)
TCR Beta (long & short read) Assay
Whole Exome Sequencing
Methylome Sequencing
Whole Transcriptome Sequencing GeneStrat Test*
(EGFR L858R, del19, UCV multiplex, T790M | ALK | ROS1 | RET | KRAS | BRAF)
SARS-CoV-2 ddPCR Test
EGFR del19 multiplex*
Microsatellite Instability
Custom Assays Nodify XL2 Test*
Lung Protein Panel (388 proteins)
Direct Neoantigen Characterization
Custom Assays VeriStrat Test*
Primary Immune Response
Lung Cancer Risk of Recurrence