The Allo-Transplantation Company Focused on better outcomes - - PowerPoint PPT Presentation
The Allo-Transplantation Company Focused on better outcomes through personalized transplant surveillance June 2020 Allo-transplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient
June 2020
Allo-transplant (allo- meaning "other" in Greek) is the transplantation of cells, tissues or organs to a recipient from a genetically non-identical donor of the same species
These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding future financial position of CareDx, Inc. (together with its subsidiaries, “CareDx” or the “Company”), including financial targets, business strategy, and plans and objectives for future operations, are forward-looking statements. CareDx has based these forward-looking statements on its estimates and assumptions and its current expectations and projections about future events. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those contained in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed or may subsequently file with the U.S. Securities and Exchange Commission (the “SEC”). In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. CareDx undertakes no obligation to update publicly or revise 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 CareDx’s expectations. These slides and the accompanying oral presentation contain certain non-GAAP financial measures, which are provided to assist in an understanding
measures prepared in accordance with GAAP. Please refer to the Appendix included in these slides for a reconciliation of the non-GAAP financial measures included in these slides and the accompanying oral presentation to the most directly comparable financial measures prepared in accordance with GAAP. Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or undertakes any obligation to update such data after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services of the Company.
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We We are committed to improving long-te term
th throughout t th the enti tire tr transplant t pati tient t journey
Th The le lead adin ing par artner for the tran ansplan lant ecosystem
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Expanding $10B+ market opportunity
Industry Leading Products & Services Leading Medicare Reimbursement Strong Clinical Data Robust End-stage Pipeline Strong Financial Position
>75 Transplant Centers Clinical Studies Quality Management >30 Transplant Centers Electronic Medical Records >60 Transplant Centers
“Liquid Biopsy” dd-cfDNA cfDNA Cell Therapy Augmented Intel Risk Prediction Gene Expression Profiling Waitlist Management High Resolution HLA matching
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New
Pre-Transplant Post-Transplant Surveillance
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Acquisitions
Partnerships / Collaborations
Pre-transplant HLA testing & international expansion Entry into digital transplant tools First dd-cfDNA technology in transplant First HLA target capture sequencing technology Global rights to NGS products in bone marrow & solid organ transplant First validated transplant AI as part of iBox
2014 2015 2016 2017 2018 2020 2019
First dd-cfDNA technology in transplant Expansion
HistoMap & UroMap
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Heart Transplant
Solid Organ Transplant
All Transplant
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Clinically validated testing protocol 15 Planned Surveillance Tests Post-Transplant 1 2 3 4 5 6 7 8 9 10 11 12 Year 1 Year 2 Year 3
KIDNEY TRANSPLANT PATIENTS
Leading science with the lowest limit of detection, now at 0.12% $2,840 CMS reimbursement coverage for 70% - 80% of patients Stratifies patients with T-cell mediated rejection Efficient care with only one tube of blood required
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Clinically validated / FDA approved AlloMap Patient Results (in Thousands)
HEART TRANSPLANT PATIENTS
Non-invasive gene expression profile test of peripheral blood Detects changes in gene expression associated with acute rejection Used by over 90% of US transplant centers $3,240 CMS reimbursement/ covered by most private payers 6 7 8 8 10 12 13 14 15 16 19 2017 2012 2014 2016 2009 2015 2010 2013 2011 2018 2019
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Note: Center penetration based on UNOS listed transplant centers as of Q1 2020; does not include non-transplant hospitals.
Deep Center Penetration Clinical Partnerships Leadership Indicators
KIDNEY HEART OTHER ORGANS
Centers Using AlloSure
Centers Using AlloMap
Centers Using AlloSure Lung
KOAR/OKRA Centers
SHORE Centers
Investigator Initiated Trials
Named Center Protocols Newly Transplanted Patients
Publications
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Transplant Centers Patient Consent Patient Care Manager Mobile Network Field Lab Support
Broad interest Rapid uptake Accelerated structure Created national phlebotomy Established customer excellence group
Centers
Patients
in 3 Weeks
Network Combined Patient Facing Employees Home Based Blood Draws for Full Blood Workup/Surveillance
Transplant Coordinator Assistants Transplant Account Manager (TAM) Medical Science Liaison (MSL)
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SOLID ORGAN TRANSPLANT CENTERS
RemoTraC Phlebotomy Field Lab Service Team EMR Solutions Community Nephrology Team Patient Care Management Team
TRANSPLANT ECO-SYSTEM
1 2 3 4 5 6
“The Only 100% Transplant Focused Company ”
Donor-derived Cell-free DNA (dd-cfDNA) Machine learning Transplant Data Analytics Gene Expression Profiling (GEP)
2020 Additions
Gene Expression/Urine
cellular rejection
ambiguous rejections
approach Graft Injury
(>7k patients) Graft Prognosis Immune Activity Gene Expression/Tissue
reproducible
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Latest Innovation
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Start Name Impact Centers Patients Samples 2020 c19txr Long-term COVID Transplant Outcomes >30 >1000* N/A 2019 OKRA Long-term Kidney Transplant Outcomes >50 >1500 >8,000 2018 SHORE Long-term Heart Transplant Outcomes >50 >3000 >8,000 2018 K-OAR Long-term Kidney Transplant Outcomes >50 >1500 >8,000 2015 DART Validation AlloSure Kidney Transplant 14 400 2,100
Transplant Centers
Transplant Investigators
Large Multi-Center Clinical Studies Investigator Initiated Trial Program Grant Support
* Expected final enrollment
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Cell Therapy Patient Monitoring Cell Therapy Addressable market
product relative to patient cells
with minimal DNA amount
validated workflow
and persistence of allogeneic cells
and experience with technology
annually…
treatment
C max Contraction Persistence Months/Years Infusion % Cell Product
Note: Cell Therapy addressable markets assumes ~180,000 hematological cancer patients, 160,000 solid tumor patients (10% penetration, and reimbursement set at current AlloSure levels; excludes upside from clinical trial partnerships.
Expansion
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and monitoring capabilities – Opportunity to personalize cell therapy
patients’ responses to therapy – Need standardized measurement
necessary to serve the cell therapy ecosystem… – Deep basic science and clinical expertise – Infrastructure in leading hospitals – Scale and existing business/service models
– Existing patient, provider and payor relationships – Transplant data/digital capabilities AlloCell: Potential to Set Standard of Care Current Short Falls
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Best-in-Class Sequencing Based Genetic Matching
Coverage includes classical and non-classical HLA
7.0Mb DPB2 DPA2 DPB1 DPA1 DOA DMA DMB Z TAP1 TAP2 DOB 6.5Mb DQB2 DQA2 DQB3 DQB1 DQA1 DRB1 DRB2 DRB3,DRB4,DRB5 DRB8 DRB9 DRA 6.0Mb 5.5Mb 5.0Mb MICB MICA S B C 4.0Mb 3.5Mb 0Mb HFE Location unknown Y F V P H G T K U A W J L N E Gene Resolution Coverage HLA-A 4th field Full gene HLA-B 4th field Full gene HLA-C 4th field Full gene HLA-E 4th field Full gene HLA-F 4th field Full gene HLA-G 4th field Full gene HLA-H 4th field Full gene DRB1 3rd field Full exon DRB3/4/5 3rd field Full exon DQA1 3rd field Full exon DQB1 3rd field Full exon DPA1 3rd field Full exon DPB1 3rd field Full exon MICA 2nd field Full exon MICB 2nd field Full exon
Donor-Recipient Matching 17 genes enables more matching points for solid organ and stem cell transplant recipients Hybrid Capture Technology enables addition of future gene content without workflow changes Data analysis in less than 30 minutes per run CE Mark May 2020
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Digital Offerings: Transplant EMR & Patient App Support EMR integration and testing protocol adherence Transplant dedicated EMR based on Cerner platform Growth from OttrSAAS, Ottr Bone Marrow and Cerner/VA implementation Leading Transplant Patient Engagement
AITraC Clinical Decision Support Ottr 3.x Electronic Medical Records XynQAPI Quality Management XynCare Waitlist Management AlloCare Patient Engagement App “Tracy” Virtual Transplant Assistant Transplant Data Platform Foundational functionality for data exploration and insights creation
Provider Solutions Patient Solutions
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13 14 16 28 49 2015 2016 2017 2018 2019 +77% 10 15 Q1 2020 Q1 2019 +50% $48 $28 2015 2017 2016 $41 $127 $77 2018 2019 +66% $38 $26 Q1 2019 Q1 2020 +48% Testing Services Patient Results (FYE-December; in Thousands) Total Revenue (FYE-December; in Millions)
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21.5 4.4 26.0 31.4 4.7 38.4 TOTAL Digital & Other Testing Services Products 2.2 +46% +6% +48% 2020 2019 Q1 Revenue (In $ Millions)
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2017 2018 Q1 2020 68% 2019 60% Q1 2019 67% 61% 71%
$4 2017 2018 2019
2017 2018 2019 Non-GAAP Gross Margin (FYE-December; % of Revenue) Adjusted EBITDA (FYE-December; in Millions) Net Operating Cash Flow (FYE-December; in Millions)
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Multi-Modality Approach Current Survival Future Survival KIRA trial RemoTraC AlloCare AiTraC Immuno- modulation Compliance and Adherence Standardization and Personalization
10 Years 13 Years
Examples of “How?” Trailblazing Innovation
Fueling Transplant R&D
Defining Standards
Testing Services Transplant Products Digital Business
Continued Adoption and Growth Global AlloSeq Launches Supporting Testing and Growth
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/ /
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Revenue 48.3 76.6 127.1 26.0 38.4 GAAP Cost of Revenue 21.4 33.0 45.5 9.7 12.4
Stock-based compensation expense
(0.2) (0.8) (2.2) (0.8) (0.4)
Acquisition related amortization of purchased intangibles
(1.5) (2.2) (2.4) (0.5) (0.8)
Acquisition related amortization of inventory valuation adjustment
(0.5)
19.2 30.0 40.8 8.5 11.2 Non-GAAP Gross Profit 29.1 46.6 86.3 17.5 27.1 Non-GAAP Gross Margin % 60% 61% 68% 67% 71%
in Millions
FY 2019 FY 2018 FY 2017 Q1 2020
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Q1 2019
GAAP Net Loss (55.5) (46.8) (22.0)
Stock-based compensation expense
1.7 7.1 22.4
Acquisition related amortization of purchased intangibles
2.4 3.0 3.6
Acquisition related amortization of inventory valuation adjustment
0.5 0.3
Change in estimated fair value of contingent consideration
1.2 1.0 0.2
Change in estimated fair value of warrant & derivative liabilities
29.6 23.0 (0.3)
Amortization of debt discount
2.1 2.1
0.3 3.0
0.3 2.8
Tax effect related to amortization of purchased intangibles
(0.7) (0.8) (0.5)
Impairment
2.0
Non–GAAP Net Income (Loss) (16.1) (5.3) 4.6
Interest income
3.8 1.6 (1.0)
Income tax benefit
(1.0) (0.6) (1.5)
Depreciation expense
0.9 1.2 1.6
Other expense, net
0.9 0.2 0.4
Net loss attributable to noncontrolling interest
(0.1) (0.0)
(11.5) (3.0) 4.2
in Millions
FY 2019 FY 2018 FY 2017
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