Biodesix Investor Deck
Transcript of Biodesix Investor Deck
© 2021 Biodesix, Inc. All rights reserved. 2
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
© 2021 Biodesix, Inc. All rights reserved. 3
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
Laboratory Manager
Researcher
Presenting today
President & Chief Executive Officer
Chief Operating Officer
Chief Financial 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
© 2021 Biodesix, Inc. All rights reserved. 4
Our mission is to improve
patient outcomes and lower
healthcare costs by
developing diagnostic solutions
that reduce ineffective and
unnecessary treatments
© 2021 Biodesix, Inc. All rights reserved. 4
© 2021 Biodesix, Inc. All rights reserved. 5
Biological Research
New Test Discovery
Test Development
Clinical Tests
Biopharma
& Academia
Healthcare
Providers
& Patients
– Blood & Tissue-based– Companion Diagnostics (CDx)– Distribute with Partners
Non-Lung
Lung
We discover, develop and commercialize diagnostic solutions for biopharma partners, healthcare providers and patients
Diagnostic Cortex™
– Blood-based
– AI Driven– Blood &Tissue-based
– Multiple Cancers & Diseases– Multiple Technologies
– Industry leading turn-around-time
– Rapid actionable insights to inform and guide diagnosis and treatment
Commercial Sales
© 2021 Biodesix, Inc. All rights reserved. 6
We focus on lung cancer because each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.
236K+ Patients will be diagnosed with lung cancer annually in the US1
Lung cancer is the leading cause of cancer death worldwide.2
Only 22% of all people diagnosed with lung cancer will survive 5 years or more.
Approximately 132K AMERICAN LIVES are lost annually.2
4M+ molecular testing opportunitieswith our commercial diagnostic tests
8 on-market diagnostic tests for patients with lung disease – 5 for lung cancer and 3 tests for COVID-19
2 pipeline diagnostic tests in development for patients with lung disease
$ 29BTotal US Opportunity
1.International Agency for Research on Cancer. GLOBOCAN Lung Cancer Facts Sheet 2020. 2. American cancer Society Cancer Facts and Figures, 2021. Atlanta: American Cancer Society 2020
© 2021 Biodesix, Inc. All rights reserved. 7
Why Biodesix? Our tests start at diagnosis and answer clinical questions for the patient throughout their entire cancer journey.
Lung Nodule Risk Assessment
Treatment Decisions
Diagnosis Treatment
Disease Recurrence & Progression
Monitoring
On M
ark
et
© 2021 Biodesix, Inc. All rights reserved. 9
5M+lung nodules annually eligible for risk assessment testing
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nodify Lung Nodule Risk Assessment Testing is the diagnostic solution for identifying risk in pulmonary nodules
of patients receiving biopsy
as the sole diagnostic
procedure were benign1
of patients who underwent surgery had benign nodules1
of patients sent to CT surveillance have malignant nodules2
62% 35% 17%
Silvestri GA, et al, Chest. 2018 Sep;154(3):491-500.
USPSTF statement to expand the eligible population for lung cancer screening (March 9, 2021).
Highlights the opportunity to improve patient outcomes and lower healthcare costs by reducing
ineffective and unnecessary treatments.
© 2021 Biodesix, Inc. All rights reserved. 10
Medicare coverage with a unique CPT code & ADLT status ($3,520)
Two studies ongoing (ALTITUDE & ORACLE) for combined lung nodule risk assessment
and over 35 peer-reviewed publications & abstracts
Efforts ongoing with payers
24-hour turnaround time 4-day turnaround time
Identifies patients with lung nodules that
are likely malignant
Autoantibodies on an ELISA platform from bloodP53 | 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 | C163AClinical Profile: Age | Smoking History | Cancer HistoryRadiologic Profile: Nodule Size | Location | Spiculation
98% NPV, 97% sensitivity & 44% specificity
Blood-Based Nodule Risk Assessment
© 2021 Biodesix, Inc. All rights reserved. 11
The importance of understanding lung nodule management
CT Surveillance
?What Next?
Physician
Judgement
Risk Calculators
Very Low Risk(<5%)
Low to Moderate Risk(5-65%)
High Risk(>65%)
~80%
~10%
Tanner et al 2015
*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).
Biopsy Surgery
or
Patient Chart
Clinical Profile• Age• Smoking History• Cancer History
Radiologic Profile• Nodule Size• Nodule Spiculation• Nodule Location
~10%
© 2021 Biodesix, Inc. All rights reserved. 12
Nodify reclassifies risk to help reduce uncertainty in lung nodule management
CT Surveillance
solitary pulmonary nodule risk calculator
Physician Judgement
Patient Chart
Clinical Profile• Age (≥40)• Smoking History• No Cancer History
Radiologic Profile• Nodule Size (8-30mm)• Nodule Spiculation• Nodule Location
Very Low Risk
(<5%)
Low to Moderate Risk(5-65%)
High Risk(>65%)
~80%
~10%
~10%Biopsy Surgery
or
identifies likely benign nodules with test results
in one week
identifies likely malignant nodules with test results in
one day
Tanner et al 2015
© 2021 Biodesix, Inc. All rights reserved. 13
We are committed to advancing our clinical data package
ALTITUDE Clinical Utility Study ORACLE Registry Study
Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules (ALTITUDE)
o First-in-class biomarker study for the early detection of lung
cancer
o Prospective, Observational, Multi-center randomized
controlled study of the Nodify XL2 and Nodify CDT tests
o Initiated December 2020
o 22 US sites
o 2,000 patient enrollment goal
o To evaluate how supplemental information from Nodify Lung
Testing impacts clinical decision making
o Interim results expected 2022
A Registry to Evaluate the Performance of the BDX-XL2 (Nodify XL2) Test (ORACLE)
o Designed to evaluate the clinical utility of the Nodify XL2 test
with the Nodify CDT test ( Phase II)
o Prospective, Observational, Registry study of the Nodify XL2
and Nodify CDT tests
o Initiated October 2018
o 15 US sites
o 1,000 patient enrollment goal
o CHEST 2021: Data from ORACLE study show that the number
of invasive procedures on benign nodules were reduced by up
to 67% with the use of the Nodify XL2 test
o 2-year follow-up anticipated in 1H 2022
© 2021 Biodesix, Inc. All rights reserved. 14
___________________________________________________________________________________________
4M+ molecular testing opportunities to guide NSCLC treatment decisions
~200k 10.5 months 26 days
Only 22% of all people diagnosed with lung cancer will survive 5 years or more. If caught early, the chance
for 5-year survival improves dramatically.
testing is the solution to giving the right treatment to the right patient as soon as possible
patients diagnosed annually
with NSCLC in the US
median overall survival of
patients with advanced stage NSCLCLength of time for turn around for
tissue testing
© 2021 Biodesix, Inc. All rights reserved. 15
Blood
Tumor & Immune MonitoringBlood Blood
Blood
7-14 days
ResultsCompetitive Liquid
Biopsy NGS
Tissue-Based NGS Tissue
26 days
Results
We offer the most comprehensive portfolio of tests with industry-leading turnaround times
36-hoursResultsBlood
Blood
72-hours
Results
Confirm
Diagnosis
Treatment
Decisions
Diagnosis Treatment
Recurrence
& Progression
Monitoring
52-genes, advanced stage NSCLC
6-genes, all stages of NSCLC
ddPCR
© 2021 Biodesix, Inc. All rights reserved. 16
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 or multiple tests per patient
per cancer
Medicare and private payer coverage with a
unique CPT code & ADLT status ($2,871)
85+ publications & abstracts30+ publications & abstracts
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
1 https://clinicaltrials.gov/ct2/show/NCT03289780
Greater than 4,000+ patients enrolled in INSIGHT1 registry study
Rapid Turn-Around Blood-Based Tumor & Immune Profiling
ddPCR
© 2021 Biodesix, Inc. All rights reserved. 17
Why physicians will choose the recently-launched GeneStratNGS™ test over others
Unique, easy-to-read report stands
apart from others
Tests for 52 well characterized and
prevalent cancer-related genes as an
aid in treatment decisions associated
with one or more genetic variations
Unprecedented 72-hour turnaround time,
plasma-based, next generation
sequencing assay for patients
diagnosed with advanced stage cancer
Therapy recommended genes also span
across other cancers such as Colorectal,
Endometrial, Breast, GI, Thyroid and Chordoma
Sensitivity of 95% and a Specificity of 100%
relative to the ddPCR reference
Billing using existing CPT code 81455 –
Medicare price of $2919
© 2021 Biodesix, Inc. All rights reserved. 18
GeneStrat NGS™ test and our new, unique ‘all-stages’ Integrated treatment guidance strategy
Immune profiling test
Immune profiling test
52-gene test
Test Request Form
submitted with
clinical information
Advanced, metastatic,
or recurrent NSCLC
Early stage
NSCLC
Blood draw
ddPCRtargeted 6-gene test
© 2021 Biodesix, Inc. All rights reserved. 19
We are committed to continually advancing our clinical data package
___________________________________________________________
INSIGHT Observational Study (NCT03289780)
Primary Immune Response (PIR) Test
___________________________________________________________
BEACON-Lung Clinical Study (NCT04676386)
An Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy tests in patients with Non-Small Cell Lung Cancer (INSIGHT)
o Designed to evaluate the real-world clinical utility and performance of the Biodesix treatment guidance portfolio of tests (VeriStrat, GeneStrat and GeneStrat NGS tests) in everyday practice.
o 35 sites enrolling
o To date, over 4,000 patents enrolled with a target of 5,000.
o Final analysis with 3 –year follow up expected 2024
A Prospective Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With An Immune Checkpoint Inhibitor (ICI) With or Without Platinum-Based Chemotherapy (BEACON-Lung)
o Designed and executed in collaboration with the Addario Lung Cancer Medical Institute (ALCMI) team with a focus on PIR to detect early progression on ICI monotherapy versus triplet therapy
o 10 sites enrolling
o Evaluate 390 patients Final Enrollment expected 2023
o Analysis expected in 2023
© 2021 Biodesix, Inc. All rights reserved. 20
Why Biodesix? Our tests start at diagnosis and answer clinical questions for the patient throughout their entire cancer journey.
Pip
elin
e
Risk of Recurrence (ROR)
Lung Nodule
Risk AssessmentTreatment Decisions
Diagnosis Treatment
Disease Recurrence
& Progression
MonitoringO
n M
ark
et
Primary Immune
Response (PIR)
© 2021 Biodesix, Inc. All rights reserved. 21
Monitoring
Our Proprietary Pipeline Tests
Treatment Guidance
Primary Immune Response (PIR) Test
– Test for selecting treatment naïve NSCLC patients for immunotherapy (immune checkpoint inhibitor) regimens independent of, and complementary to PD-L1 status
– Launched BEACON-Lung Clinical Study (NCT04676386) in collaboration with Addario Lung Cancer Medical Institute (ALCMI) and included PIR test
– Anticipated launch 2023
Risk of Recurrence (RoR) Test
– Host immune profiling signature that identifies stage 1 NSCLC pre-surgery patients who are a higher risk of recurrence (ROR) and may benefit from adjuvant chemotherapy
– Anticipated launch 2023
© 2021 Biodesix, Inc. All rights reserved. 22
Where our peer-products fit along the patient treatment pathway
LUNG NODULE RISK ASSESSMENT
CONFIRM DIAGNOSISTREATMENT DECISIONS
DIAGNOSIS TREATMENT
DISEASE RECURRENCE & PROGRESSION
MONITORING
imaging (CT & PET)
biopsy
surgery
Percepta(Veracyte)
Nasal Brushing Classifier(Veracyte)
Not broadly available yet
DetermaDx(Oncocyte)
failed in validation
Guardant360 CDx(Guardant Health)
FoundationOne Liquid CDx(Foundation Medicine)
FoundationOne CDx(Foundation Medicine)
Imaging
(CT & PET) symptoms
© 2021 Biodesix, Inc. All rights reserved. 23
What makes Biodesix different for biopharma partners?
Proprietary,
Transparent
AI -Driven
Approach with the
Diagnostic Cortex
Platform
Approach difficult biomarker problems in an explainable, unbiased manner
Expertise in
multiple cancers
and diseases
Broad experience in multiple cancers, disease types, and uncovering host biology in systemic
diseases
Access to multiple
technologies
Molecular and proteomic technologies –tumor and host biology monitoring
Development in tissue and blood
Industry leading
turnaround time
Critical for prospective trial enrollment
© 2021 Biodesix, Inc. All rights reserved. 24
A multi-technology approach integrated with transparent AI is critical to discover advanced diagnostic solutions for our biopharma partners
TUMOR PROFILING
Biomarkers
• Genomics (DNA, RNA)• Proteomics• Radiomics• Epigenomics• Transcriptomics
Our Technologies
• Droplet Digital PCR• Next Generation Sequencing• Liquid Chromatography MS (LC MS)• ELISA
IMMUNE PROFILING
Biomarkers
• Proteomics
• Genomics• Post Translational Modifications
Our Technologies
• Deep MALDI Mass Spectrometry• Liquid Chromatography MS
(LC MS)• PASEF – timsToF Mass
Spectrometry• Next Generation Sequencing • ELISA
DIAGNOSTIC
CORTEX®
ARTIFICIAL
INTELLIGENCE
PLATFORM
© 2021 Biodesix, Inc. All rights reserved. 25
Biodesix develops diagnostic solutions to support our biopharma partners in bringing novel therapies to market
50+companies
150,000+ sample & data biobank
Significant experience to date working
with biopharma customers
Select publicly-disclosed
biopharma customers
© 2021 Biodesix, Inc. All rights reserved. 26
Biological Research
New Test Discovery
Test Development
Clinical Tests
Biopharma
& Academia
Healthcare
Providers
& Patients
– Blood & Tissue-based– Companion Diagnostics (CDx)– Distribute with Partners
Non-Lung
Lung
We discover, develop and commercialize diagnostic solutions for biopharma partners, healthcare providers and patients
Diagnostic Cortex™
– Blood-based
– AI Driven– Blood &Tissue-based
– Multiple Cancers & Diseases– Multiple Technologies
– Industry leading turn-around-time
– Rapid actionable insights to inform and guide diagnosis and treatment
Commercial Sales
© 2021 Biodesix, Inc. All rights reserved. 28
Extensive knowledge in diagnostics & reimbursement
Scott HuttonCEO
Robin Harper CowieCFO
Kieran O’KaneCCO
Gary PestanoCDO (PhD)
Robert GeorgantasSVP Research (PhD)
Paul BeresfordCBO (PhD)
Bobbi CoffinCGO
James JettCMO (MD)
Steven SpringmeyerCMO (MD)
Linda TraylorVP CDMA (PhD)
Ryan SiurekCAO
Brianna PhillipsHead Qual & Reg
© 2021 Biodesix, Inc. All rights reserved. 29
John PatienceCHAIRMAN
Scott HuttonPRESIDENT & CEO
Hany MassaranyCOMPENSATION COMMITTEE
Jean FranchiAUDIT COMMITTEE
Matt StrobeckNOMINATIONS & GOVERNANCE COMMITTEE
Jack Schuler
Charles Watts, M.D.
A Board of Directors with a vast amount of industry expertise
Birchview Capital
Crabtree Partners LLC
© 2021 Biodesix, Inc. All rights reserved. 30
PCR Testing to Assess Active Infection
– Biodesix PCR tests use highly sensitive droplet digital PCR (ddPCR) technology to identify the presence of the SARS CoV-2
virus that causes COVID-19
– Results Available within 24-48 hours of laboratory receipt
– Specimen Collection uses a simple nasal swab, with step-by-step instructions for on-site collection and shipment of test specimens to our central laboratory in Boulder, CO
Antibody Testing To Assess Previous Infection or COVID-19 Vaccine Response
Neutralizing Antibody Testing
– Fast detection of neutralizing antibodies from previous SARS-CoV-2 infection or response from COVID-19 vaccines
– Blood test with results available within 24 hours of laboratory receipt
Total Antibody Testing
– Supports rapid detection of previous SARS-CoV-2 infection after eight days from symptom onset
– Blood test with results available within 24 hours of laboratory receipt
Dual Antibody Testing
– Comprehensive antibody testing can be achieved though testing a single blood specimen with both Neutralizing and Total Antibody tests in 24 hours from laboratory receipt
Biodesix Covid-19 Testing Menu
© 2021 Biodesix, Inc. All rights reserved. 31
We have two certified, high-complexity laboratories
DE SOTO, KSBOULDER, CO
✓ CAP-accredited✓ CLIA-certified✓ NYS CLEP certified: Soluble Tumor Markers,
Molecular & Cellular Tumor Markers and Virology✓ ISO 13485-certified✓ FDA Emergency Use Authorization
✓ CAP-accredited✓ COLA-accredited✓ NYS CLEP certified: Soluble Tumor Markers &
Diagnostic Immunology✓ ISO 13485-certified✓ FDA Emergency Use Authorization
© 2021 Biodesix, Inc. All rights reserved. 32
Intellectual property portfolio
99 issued patents50 in the US and 49 foreign;19 U.S. and 21 foreign applications still in various stages of prosecution
26 unique & active
registered trademarksacross 11 countries
Patent Subject Matter:• VeriStrat and Nodify tests and their uses in non-small cell
lung and other diseases (e.g. breast cancer, prostate cancer, liver cancer, graft v. host disease)
• DeepMALDI mass spectrometry methods• Classifier development using the Diagnostic Cortex• Pipeline tests using proteomic testing in immunotherapies• Biodesix Blood Collection Device• Proteomic drug-associated tests developed for our 3rd
party partners
Exemplary Issued Marks:• Biodesix• Biodesix Lung Reflex• VeriStrat• GeneStrat• DeepMALDI• Diagnostic • ImmunoStrat• Nodify• Nodify Lung• Nodify XL2• Nodify CDT
Additional Filed Marks:• IQlung• IQlung + Logo• SimpleSep