CareDx, Inc.

Good day everyone and welcome to today's CARE-DX first quarter 2025 earnings conference call. At this time all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. Please note this call may be recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Ms. Caroline Corner, Investor Relations. Please go ahead.

Thank you, Operator. Thank you for joining us today. Earlier today, CareDX released financial results for the first quarter of 2025, ending March 31, 2025. The release is currently available on the company's website at www.CareDX.com. John Hanna, President and Chief Executive Officer, Robert Woodward, Chief Scientific Officer, and Abhishek Jain, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements on this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing, and enrollment matters, and our financial expectations and results are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, April 30th, 2025. CareDX disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise. This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measures may be found in today's earnings release filed with the SEC. I will now turn the call over to John.

Thank you, Caroline, and welcome to everyone joining today's call. We are broadcasting today live from Boston, Massachusetts, at the 45th Annual Meeting of the International Society of Heart and Lung Transplantation, where 60 abstracts, including 19 oral talks, were presented from data collected from over 90 transplant programs across the country on the use of CARE-DX solutions. To provide some context, there are approximately 170 health systems in the United States that have a heart or lung transplant program. That means novel data was presented this week on the use of CARE-DX products from approximately half of the heart and lung transplant centers in the United States. Later in the call, I will ask Robert Woodward, our Chief Scientific Officer, to share the highlights of several key abstracts. We made good progress against our drivers of growth in the first quarter of 2025. It was our seventh consecutive quarter of sequential testing volume growth. Our testing services grew across all three organs, heart, kidney, and lung. We launched two expanded indications for Allishore, made progress with publications, and continued to execute against our revenue cycle management and market access strategies. It has been a busy first quarter, and we are gaining momentum on delivering on our mission to create life-changing solutions that enable transplant patients to thrive. I'll now dive into some of the first quarter performance and progress against our growth drivers. In the first quarter, we reported quarterly revenue of $84.7 million, up 18% year over year, and a positive adjusted EBITDA gain of $4.6 million. Positioned to build upon that performance, we are reiterating our 2025 guidance of $365 to $375 million in revenue and an adjusted EBITDA gain of between $29 million and $33 million, and our long-range plan of achieving $500 million in revenue and 20% adjusted EBITDA in 2027. We ended the quarter with a strong cash balance of $231 million and no debt. In testing services, revenue was $61.9 million for the quarter, up 15% year over year. We delivered testing services volume of approximately 47,100 tests in the first quarter, up 12% from the prior year. Daily testing volumes increased in February and March and have continued through April, led by Allishore Kidney Surveillance Testing growth. Our increased sales footprint is having an impact, and I'm pleased with the progress we continue to make expanding kidney surveillance testing protocols. In March, we launched two expanded indications for Alisher testing. First, Alisher Heart is now the only test validated and commercially available for pediatric heart transplant patients under age 7, including infants. Expanding the clinical indication of AlloSure for this population is important because it allows us to service the entire market and shows our commitment to pediatric transplant programs. To frame this opportunity, over the past three years, there were approximately 500 heart transplants annually in patients under the age of 18. The second indication expansion is for AlloSure Kidney. which is now validated and commercially available for simultaneous pancreas kidney transplant patients. Simultaneous pancreas kidney transplants are primarily performed for patients with renal failure and insulin-dependent diabetes and is a growing indication because it cures both diseases in a single procedure. In 2024, more than 700 patients received a simultaneous pancreas kidney transplant. We also made strong strides with payers this quarter, executing against our market access strategy of publishing evidence, expanding medical policy coverage, and getting into payer networks. In the first quarter, we submitted the second manuscript from the SURE study assessing the use of heart care in the management of over 2,700 heart transplant patients at 67 centers in the U.S. As a reminder, We submitted the first manuscript from the CAOR study of over 3,600 kidney transplant patients from 56 transplant centers, and we anticipate these publications to contribute to heart care and Allishore kidney coverage in future quarters. In the first quarter, we added 3.5 million new covered lives for Allimap heart and 15.5 million new covered lives for Allishore testing. Early in the quarter, we were issued a new CPT code for Allishore that became active for use on April 1, 2025. And as a result, we converted six of our existing payer contracts to the new Allishore-specific code and were able to obtain in-network status with a new large Blue Cross Blue Shield plan in the southeast with over 3 million covered lives. We believe the combination of additional published evidence, Coverage gains and in-network contracts will lead to ASP gains in future quarters. I'd like to now turn it over to Robert Woodward to talk briefly about some of the important clinical evidence that was presented this week at the ISHL team meeting in Boston.