CareDx(CDNA) - 2024 Q3 - Quarterly Results

Introduction This section provides an overview of the presentation's forward-looking statements and the use of non-GAAP financial measures Safe Harbor Statement This section outlines forward-looking statements, subject to risks detailed in SEC filings, with no obligation to update - The presentation contains forward-looking statements regarding CareDx's future financial position, targets, business strategy, and objectives, which are subject to risks, uncertainties, and assumptions detailed in SEC filings (Form 10-K for FY2023, Form 10-Q for Q1 and Q2 2024)[2][3] Non-GAAP Financial Measures & Data Sources CareDx clarifies non-GAAP measures are supplementary to GAAP and external data is unverified - Non-GAAP financial measures are provided to assist in understanding the business and performance, and should be considered only as a supplement to, not superior to, GAAP measures[4] - Certain data in the presentation was obtained from external sources and has not been independently verified by the Company or its affiliates[4] Establishing CareDx as the Most Innovative Company in Diagnostics CareDx positions itself as a leader in diagnostics, driven by a strong leadership team, a focused market approach, and innovative product offerings Leadership Team Introduces CareDx's core leadership team, responsible for strategy, innovation, commercial, and financial management - Key leadership includes John Hanna (President & CEO), Robert Woodward (Chief Scientific Officer), Jessica Meng (Chief Commercial Officer), Keith Kennedy (Chief Operating Officer), Abhishek Jain (Chief Financial Officer), and Marica Grskovic (Chief Strategy Officer)[6][7][8][9][10][11][12] Company Overview: Team, Market, Products CareDx showcases its global team, $50B transplant market presence, and leading solutions provider status with widespread product adoption - CareDx has 650 employees globally, including 110 scientists & researchers and 80 software programmers, demonstrating a strong focus on innovation and digital solutions[15] Transplant Market Metrics | Metric | Value | | :----- | :---- | | US Transplant Centers | 250 | | Transplant Services Market | $50B | | Transplants Annually | 46K | | Annual Growth in Transplants | 6% | Product Adoption Metrics | Metric | Value | | :----- | :---- | | Rejection Monitoring Tests Performed | 1M | | HLA Typing Kits Sold Annually | 200K | | Centers Use One Or More Software Products | 70% | | Rx Filled Annually by Transplant Pharmacists | 20K | Preliminary Q3 2024 Results CareDx reports strong preliminary Q3 2024 results with significant year-over-year revenue growth and a healthy cash balance Preliminary Q3 2024 Financials | Metric | Value | YoY Change | | :----- | :---- | :--------- | | Total Revenue | $82M to $83M | ~23% increase | | Testing Services Revenue | $60M to $61M | ~26% increase | | Testing Services Volume | 44.6K | ~16% increase | | Digital & Patient Solutions Revenue | $11.9M | 20% increase | | Products Revenue | $10.2M | 7% increase | | Cash, cash equivalents, and marketable securities | ~$240M | N/A (no debt) | Guiding Principles & Unique Market Position CareDx's principles emphasize execution, customer focus, and innovation, leveraging its unique market position for profitable growth - Guiding principles for growth include strong execution with a strong team, putting the product and customer at the center, and investing in product and business innovation to deliver breakthrough growth[18] - CareDx holds a unique position in molecular diagnostics by concentrating on the transplant market, which allows for lower customer acquisition costs and cross-selling products and services, leading to profitable growth[18][19] Strategic Priorities CareDx defines four strategic priorities: profitable growth, operational excellence, Transplant+ expansion, and performance culture - CareDx's strategic priorities are Profitable Growth, Operational Excellence, Define Transplant+, and Elevate Performance Culture[20] Unlocking Building Blocks of Growth CareDx's growth strategy focuses on expanding its market presence and product offerings within the transplant sector and beyond Transplant Market Total Addressable Market (TAM) CareDx identifies an over $8 billion transplant TAM, impacting a large patient population across testing, digital, and lab products - The total addressable market (TAM) for transplant solutions is estimated at over $8 billion, covering testing services, digital solutions, and lab products[22] - There are 280,000 organ transplant patients in the U.S. and 100,000 patients on the transplant waitlist, highlighting a significant patient impact opportunity[21][22] Four Building Blocks of Growth CareDx's growth strategy is built on increasing transplant volume, customer adoption, patient adherence, and product pipeline expansion - The four building blocks of growth are Transplant Volume, Customer Adoption, Patient Adherence, and Product Pipeline[23] Transplant Volume Growth Transplant volume growth is driven by government initiatives expanding access and technological advancements improving organ viability - Transplant volume growth is driven by growing government efforts to expand transplantation access (e.g., IOTA Model, Biden Administration overhaul) and technological advances improving organ viability (e.g., hypothermic oxygenated perfusion, Felzartamab trial)[23] Customer Adoption CareDx's synergistic portfolio drives customer adoption, with multi-solution accounts generating twice the testing services revenue - CareDx offers a synergistic portfolio of solutions across the patient journey, including Lab Products (HLA Typing, Lab Management Software), Transplant Center solutions (EMR, Quality Reporting), and Patient DX & Solutions (Remote Monitoring, Graft Health Assessment)[24] - Accounts that have 3 or more CareDx solutions demonstrate higher average new transplant patient acquisition (44% vs 29%) and generate 2x the average transplant center revenue from testing ($1.2M vs $600K)[25][26][27][28] Patient Adherence CareDx aims to improve patient adherence to post-transplant testing protocols using digital solutions to bridge current testing gaps Patient Adherence to Testing Protocols | Organ | Product | Center Protocol (tests in first 3 years) | Current Tests (in first 3 years) | | :---- | :------ | :--------------------------------------- | :------------------------------- | | Kidney | AlloSure® | 15 | 7 | | Heart | HeartCare® | 38 | 24 | | Lungs | AlloSure® | 20 | 10 | - CareDx plans to leverage digital solutions like MedActionPlan® and TransplantPharmacy* to improve patient adherence to testing protocols for AlloSure® (Kidney, Lungs) and HeartCare®[30][31] Product Pipeline CareDx's product pipeline fuels growth through expanded indications for existing tests and the launch of new diagnostics - The product pipeline includes expanded indications for AlloSure SPK (simultaneous pancreas and kidney transplantation) and AlloSure Heart PEDS (validated for patients <15 years old)[32] - New diagnostic launches include AlloMap Kidney (gene-expression profiling complementing AlloSure Kidney) and UroMap (urine-based test for patients with high BKV viremia)[32] Securing Coverage & Adoption Through Evidence CareDx strategically generates robust clinical evidence to secure broader coverage and drive physician adoption of its diagnostic solutions Evidence Generation Strategy CareDx employs a robust evidence strategy, including meta-analyses and clinical utility studies, to boost coverage and physician adoption - CareDx's evidence generation strategy focuses on increasing coverage and adoption through clinical utility, decision impact, physician adoption, and clinical validation, supported by meta-analysis of clinical studies and outcomes[33] Clinical Evidence Highlights Key clinical studies demonstrate CareDx's non-invasive tests accurately detect rejection, improve outcomes, and reduce biopsy needs - SHORE results demonstrate the value of HeartCare, showing that dual positive HeartCare results are associated with the highest incidence of Acute Cellular Rejection (ACR) and that HeartCare outperforms dd-cfDNA alone in detecting rejection[35][36] - A landmark Nature Medicine publication highlights the utility of AlloSure Kidney, demonstrating its independent prediction of allograft rejection, detection of subclinical rejection in stable patients, and that dd-cfDNA levels elevate prior to rejection and decline in response to treatment[37] Coverage Growth & Unmet Needs CareDx's evidence generation has led to growing Medicare and commercial coverage, addressing unmet needs through primary studies - Intentional evidence generation has led to growing coverage, including Medicare coverage for AlloSure Kidney (launched 2017/covered 2017), AlloSure Heart (launched 2018/covered 2020), and AlloSure Lung (launched 2021/covered 2023)[38] Primary Studies for Unmet Needs | Organ | Generating Evidence Focus | Primary Study | Study Composition | | :---- | :------------------------ | :------------ | :---------------- | | Heart | Pediatrics Validation, 5-year Survival, Directing Therapeutic Treatment | SHORE | >2,700 patients, 5-year follow-up, 67 sites, HARTS protocol | | Kidney | Procedure Decision Making, Treating Subclinical Rejection, 3-year Survival | KOAR, OKRA | >3,600 patients, 3-year follow-up, 56 sites, ARTS protocol | | Lung | Surveillance Outcomes, Subclinical Rejection, All Transplant Coverage | ALAMO | 500 patients, 5-year follow-up, 19 sites, ALRTS protocol | Driving Operational Leverage CareDx focuses on operational leverage through volume acceleration, scalable operations, technology utilization, and profitability improvements to ensure predictable margins Principles of Operational Leverage CareDx's operational leverage focuses on accelerating volume, scaling operations, leveraging technology, and improving profitability - Operational leverage is driven by accelerating volume, scaling operations, leveraging technology, and improving profitability to ensure long-term predictability of margins[40] Strategies for Operational Leverage CareDx employs strategies to drive volume, scale operations, leverage technology, and accelerate profitability for long-term margin predictability - To Drive Volume, CareDx focuses on integrating commercial strategy, maximizing EMR integrations (Epic, Cerner), and integrating proprietary portals from acquired companies[40][41][42][43][44] - To Scale Operations, strategies include unlocking efficiencies through the supply chain, automating lab workflows, streamlining testing platforms, and assessing geographic opportunities to improve cost and turn-around times[40][41][42][43][44] - To Leverage Technology, CareDx plans to deploy low-key automation across workflows and integrate lab information systems (LIMS) with enterprise data warehouse and Business Intelligence (BI) tools[40][41][42][43][44] - To Accelerate Profitability, strategies include delivering value on cover contracting, improving eligibility, prior authorizations, and appeal processes, and improving margin on a per-test basis[40][41][42][43][44] Driving Shareholder Value Through KPIs CareDx aligns operational strategies with KPIs to increase volume, revenue, gross margin, and EBITDA while reducing OpEx for shareholder value Key Performance Indicators for Shareholder Value | KPIs | Drive Volume | Scale Operations | Leverage Technology | Accelerate Profitability | | :--- | :----------- | :--------------- | :------------------ | :----------------------- | | Volume | ▲ | ▲ | ▲ | | | Revenue | ▲ | ▲ | | ▲ | | Gross Margin | | ▲ | ▲ | ▲ | | OpEx | | ▼ | ▼ | ▼ | | EBITDA | ▲ | ▲ | ▲ | ▲ | Charting a Clear Path to Profitable Growth CareDx outlines its strategy for achieving profitable growth through financial targets and a disciplined capital allocation framework Profitable Growth & Capital Allocation Framework CareDx outlines a framework for profitable growth focusing on CAGR, Adjusted EBITDA, and cash generation, supported by strategic capital allocation - CareDx's path to profitable growth involves focusing on Compounded Annual Growth Rate (CAGR), Adjusted EBITDA, and Cash Generation, supported by strategic capital allocation including M&A and investment in the core business[46] Financial Targets CareDx targets 2027 financial goals: 15% 3-year revenue CAGR, >70% gross margin, 20% adjusted EBITDA, and +$100 million incremental cash 2027 Financial Targets | Metric | Target | Timeline | | :----- | :----- | :------- | | 3-Year Revenue CAGR | 15% | N/A (based on 2024 guidance) | | 2027 Gross Margin | >70% | 2027 | | 2027 Adjusted EBITDA | 20% | 2027 | | 3-Year Incremental Cash | +$100M | N/A | Strategic Capital Allocation CareDx prioritizes capital allocation for business development, M&A, core business investment, and share buybacks - Strategic capital allocation priorities include business development and M&A, investment in the core business, and share buybacks[49] Expanding Our Footprint Beyond $8B TAM CareDx aims to expand its market beyond the current $8 billion TAM by exploring new biomarker indications, extending monitoring, and leveraging data assets Strategy to Expand TAM CareDx's strategy to expand beyond its $8 billion TAM involves new biomarker indications, extended monitoring, and leveraging multidimensional data - CareDx's strategy to expand beyond the $8 billion TAM includes pursuing new indications for transplant biomarkers, extending beyond solid organ transplant monitoring, and capitalizing on its expansive multidimensional transplant data[47] New Indications for Transplant Biomarkers CareDx explores new transplant biomarker indications in organ perfusion, xenotransplantation, and immunosuppression drug monitoring - New indications for transplant biomarkers include organ perfusion, xenotransplantation/bioengineered organs, and immunosuppression drugs[48] Extending Beyond Solid Organ Transplant Monitoring CareDx expands monitoring beyond solid organ transplants to blood cancer, solid cancer, and autoimmune disorders, showing promise in early clinical data - CareDx is extending its monitoring capabilities beyond solid organ transplant to include blood cancer, solid cancer, and autoimmune disorders[50][51][52][53] - AlloCell surveillance, a universal assay based on DNA differences, has demonstrated clinical performance in CAR-T cell therapy patient monitoring in early clinical data[54] - AlloHeme detects cancer relapse post-stem cell transplant, with early clinical data showing correlation with relapse risk in blood cancer patients and earlier relapse prediction compared to standard of care[55] Capitalizing on Multidimensional Transplant Data CareDx leverages its extensive multidimensional transplant data with AI for outcome prediction, clinical trials, and treatment effectiveness assessment Multidimensional Transplant Data Repository | Phase | Patients | Records | | :---- | :------- | :------ | | Pre-Transplant/Wait List | 185K | >9M | | Peri-Transplant/Quality | 735K | >220M | | Post-Transplant/DX Testing | 150K | >920M | | Post-Transplant/Medication Management | 130K | >20M | | Post-Transplant/Remote Monitoring | 1K | >1M | - CareDx plans to apply AI to its expansive multidimensional data-set for outcome prediction, clinical trials, and evaluating treatment effectiveness[57][58] Activating Our Strategy CareDx implements its strategic priorities and growth building blocks to achieve financial targets and become a leading diagnostics innovator Strategic Priorities & Growth Building Blocks CareDx reaffirms strategic priorities and growth building blocks as foundational to achieving objectives, reporting $324 million net revenue in 2024 - CareDx's strategic priorities are Profitable Growth, Operational Excellence, Define Transplant+, and Elevate Performance Culture[56] - The building blocks for growth—Transplant Volume, Customer Adoption, Product Pipeline, and Patient Adherence—contributed to a 2024 net revenue of $324 million[57] 2027 Financial Targets CareDx reiterates 2027 financial targets: $500 million revenue, 20% adjusted EBITDA, and $100 million 3-year incremental cash 2027 Financial Targets Summary | Metric | Target | | :----- | :----- | | 2027 Revenue | $500M | | 2027 Adjusted EBITDA | 20% | | 3-Year Incremental Cash | $100M | Conclusion CareDx implements its strategy with a strong team, market opportunities, and innovative solutions to become the most innovative diagnostics company - CareDx is activating its strategy by putting in place the right team, identifying market opportunities, and launching innovative solutions to resolve unmet medical needs[59] - The company's overarching vision is to be recognized as the most innovative company in diagnostics[60]