CareDx, Inc.

Greetings and welcome to the CareDx Incorporated second quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Ian Cooney, Vice President of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended June 30th, 2021. The release is currently available on the company's website at www.caredx.com. Reg Cito, President and Chief Executive Officer, and Ankur Dhingra, 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 during this call that include forward-looking statements within the meaning of 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 facts 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 future 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. 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 Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, July 29th, 2021. 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 measure may be found in today's earnings release filed with the SEC. I will now turn the call over to Reg.

Thanks, Ian, and welcome to KDX. Good afternoon, everyone. and thank you for joining us for CareDx's second quarter 2021 earnings conference call. Today, I'll focus on five key highlights from the quarter. The first is our record revenue growth driven by testing services. The second is expanding our leadership across new organ areas. The third is continued leadership with innovation from both our internal pipeline and from external partnerships. The fourth is building on our 2021 theme of connecting the patient as part of the patient journey. The fifth is to highlight our excellent financial position and the increase of our four-year guidance to be covered by UNCA. On the first topic, we had another stellar quarter of growth. Our record 77% growth in total revenue from last year's go-quarter was driven by new volume hires with our patient testing services. Our sustained success is because we focus on bringing leading innovation to meaningfully improve the outcomes of transplant patients. Our 100% focus on the transplant patient over two decades has led many to consider and to call us the transplant company. As part of this, I want to thank each and every one of the CADX team in delivering on our vision on being the leading partner in transplantation. For the second quarter results, total revenue was 74.2 million, increasing 77% compared to the year-ago quarter. The main driver of growth in the quarter was from our testing services revenue which increased 79% to 64.9 million. In addition, revenue from our products business increased 108% to 6.9 million, and digital and other revenues contributed 2.4 million to the top line. I'd like to highlight the global products business was in launch mode at the start of the pandemic. The H1 2021 performance is a reflection of improved conditions at XUS, as well as the strong demand for NGS products that we deliver. The products team is excited to be in launch mode again. In the second quarter, CareDX provided 37,400 L-SHORE and L-MAP test results to transplant patients, growing 109% from the second quarter of 2020. Approximately 6,600 of these tests were part of heart care. Our comprehensive gene expression and donorized cell-free DNA assessment graph rejection. At the end of June, more than 295 kidney centers and community practices and greater than 120 heart centers were using our offerings. Notably, more than 65 kidney transplant centers in the United States have now adopted an Allishore testing protocol. Our direct-to-center approach remains core to our strategy, where we are focused on building the mode through an expanded portfolio of offerings within the transplant centers and by increasing the number of Allishore testing protocols. We've also started to replicate our unique service model in building our community nephrology presence. In this way, our team can be more effective in connecting transplant patients and the community nephrologist once their care has been transferred from the transplant center. We're uniquely positioned to play the role of connecting the patient, especially as we take a long-term focus on the transplant patient journey. During Q2, we continue to expand on our leadership through multimodal innovation to new areas. In liver, we announced enrollment of the first patient in the MAPLE study. MAPLE is a 1,500-patient multicenter prospective study using our multimodality approach to assess the status of liver allografts. For lung, we're very excited by Alishore Lung as new innovation for lung transplant patients, especially as 50% of allografts fail within five years. Our submission is under technical review by Moldex as part of the new LCD process. As previously mentioned, we had submitted Alishore Lung in the middle of last year. In support of driving record growth and leadership, we are hyper-focused on leading with innovation and scientific data generation. At the two largest transplant conferences in 2021, ICHLT and HEC, our testing services offerings an innovative pipeline with a focus of more than 65 scientific abstracts. It takes an incredible commitment to build such a significant body of clinical data, especially in the diagnostic space. Again, this has only been possible because we're 100% focused on transplant and the transplant patient. The key highlight from the HEC conference was the announcement of KL1000, the analysis of our one-year data from the first 1,000 patients enrolled in the KL study. This prospective study included more than 50 transplant centers and was designed to evaluate the safety and efficacy outcomes in kidney transplant recipients whose post-transplant care is managed using Alloshore. The noteworthy findings from the first 1,000 patients were one-year graft survival among patients monitored with Alloshore was higher than those of patients reported in the National UNOS Registry data. Alloshore use in patient management significantly reduces the number of biopsies performed as compared to biopsies guided by serum creatinine and Alloshore discriminates rejection from no rejection in both routine surveillance and full-cause groups. We're also delivering innovation in the stem cell and cell therapy space. These are substantial longer-term opportunities that we are executing against. With our proven track record to understand patient needs, clinician preferences, and the center workflow, we're able to develop these testing solutions by leveraging our broad technological capabilities. We recently announced the launch of Alloheme in the Acrobat study, introducing our latest innovation in testing services for stem cell transplant patients. In driving transplant innovation, we also continue to support the broader ecosystem by investing in and acquiring or partnering with innovative companies. For example, in May we announced an investment in Mirror Matrix, a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs. With close to 120,000 people in the U.S. on the wait list and only 40,000 valuable organs per year, We believe in investing in companies addressing organ availability through novel innovations. In June, we augmented our pipeline with OrganX through a strategic agreement which will develop advanced analytics and AI to integrate our shore data with large transplant databases to provide clinical data solutions. We've also shared that for 2021, our key theme is connecting the patients as part of the transplant patient journey. We recognized early on the strategic value of patient care managers and have now added digital platforms to strengthen this patient interaction. We've also expanded the availability of our AlloCare app to Android platforms. Today, we have an easy-to-use mobile app designed to help organ transplant patients manage their medications, schedule lab appointments, and view their test results. This app will be augmented by our acquisition of Transplant Hero, a mobile application provider of novel cloud-based medication management solutions for patients. As we continue to connect the transplant patient, we now manage more than 29,000 referrals from dialysis practices to the transplant centers and more than 7,000 patients on the wait list at centers. We have also more than 9,000 patients that have signed up for Remotrack. Before turning the call over to Ankur to discuss our financials, I'd like to say how pleased I am to have Dr. Hannah Valentine join our board. Dr. Valentine is Professor of Medicine at Stanford and former Chief Scientific Officer for Science, scientific workforce diversity at the National Health Institutes, NIH. We're excited to have Dr. Valentine join our board, and we all look forward to working with her and learning from her. Now handing over to Ankur.