8/20/2020

speaker
Operator
Conference Operator

Greetings. Welcome to CARE-Dx, Incorporated's second quarter 2020 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. Please note this conference is being recorded. I will now turn the conference over to Greg Medachuk. Thank you. You may begin.

speaker
Greg Medachuk
Investor Relations

Good afternoon and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended June 30, 2020. The release is currently available on the company's website at www.caredx.com. Peter Mogg, Chief Executive Officer, and Michael Bell, 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 the federal securities laws. which are made pursuant to the safe harbor provisions of the Private Securities 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 are 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. The information provided in this conference call speaks only to the live broadcast today, August 4, 2020. 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 FCC. I will now turn the call over to Peter.

speaker
Peter Mogg
Chief Executive Officer

Thanks, Greg, and good afternoon, everyone. I'm pleased to welcome you to CareDx's call to review our results for the second quarter of 2020. Back on April's call, I began by talking about how we chose Transplant Proud as our theme for 2020 and how proud I was of our team's response to the COVID crisis. Today, I can say that our team has taken CareDx to a whole new level. The dedication and resiliency of every member of Care DX is truly inspiring. I want to thank our employees and say you have made the lives of transplant patients and their caregivers better because of your grit, your hard work, and your devotion. You exemplify what essential businesses and workers stand for. Thanks for leaning in. Now turning to our exceptional results for the quarter. In the second quarter of 2020, we reported revenue of $41.8 million, an increase of 33% compared to the second quarter of 2019. Growth primarily came from our testing services, with revenue of $36.3 million. We provided over 17,100 allosure kidney and allomap heart patient results, an increase of 44% year over year. Product revenue for the quarter was 3.3 million, and digital revenue added 2.2 million to the top line. We believe that these are exceptional results in a challenging environment. During this crisis, we have chosen to invest strategically in areas that will accelerate the building of our mode in transplant care. We are leaning in. These strategic areas include our direct-to-patient capabilities and our clinical activities, especially those focused on our multimodality testing and digital solutions. These investments will all accelerate our precision medicine offerings in transplantation. Our digital acquisitions have proven to be a tremendous asset as it has enabled us to pivot faster than anyone in the industry in building out our offerings. Transplant Proud. In the latter part of March and throughout the second quarter, several cities experienced rapid increases in newly confirmed cases of COVID-19. With these increases came more requests from physicians and patients for remote track and mobile phlebotomy. As a result, our remote track services have experienced continued growth. For the quarter, over 40% of our patients' results originated from remote track or other mobile phlebotomy services. Under the tremendous leadership of Red Theto, in just over four months, RemoDrac has gone from an idea, gone from conversations with clinicians to a full service offering that now originates a significant proportion of our patient results. RemoDrac has provided patients peace of mind by giving them the ability to avoid transplant centers and physician offices, thus reducing the risk of contracting COVID-19. To date, around 150 transplant centers are offering RemoTrack to their patients, and over 4,000 kidney, heart, and lung transplant patients have enrolled. Our nationwide network of mobile phlebotomists has grown to over 10,000. Not only have we had to change the way we call on customers, but the pandemic has also changed the way we communicate and present important clinical information to leaders in the field of transplantation. In late May, at the Virtual American Transplant Congress Annual Meeting, our program included virtual abstract sessions, virtual symposia, and prominent authors delivering 10 abstracts. Cutting-edge content on AlloShore, Allomath, iVox, and KidneyCare was presented. Having 10 abstracts accepted for presentation at ATC and having over 1,000 clinicians, patients, and investors log on to our virtual sessions was exceptional. and quite an honor for our clinical team which is led by Chandra Lakia. The large turnout for our virtual events demonstrates our leadership position in transplant care as we are at the forefront of innovation in this space. Others might be talking, CareDx is doing, and the field is recognizing our efforts and our dedication. We are also using these new tools to communicate to clinicians and patients and during industry conferences and interactions with the transplant community. We are very encouraged by the positive feedback from nephrologists, cardiologists, transplant coordinators, and patients about our virtual advisory board. We have and will continue to virtually support our customers and to call on our physician advocates and transplant center administrators to every extent possible. While we have successfully pivoted our testing services business with exceptional success, we also point out that our product business, with its many launches, has been negatively impacted by the COVID pandemic. Hospitals and transplant laboratories across the U.S. and Europe have restricted access to their facilities for outside personnel. In May, we received CE Mark for AlloCPX17, our best-in-class solution for HLA matching. of Transplant Donors and Recipients. Despite providing better care for patients by extending the typing range to non-classical HLA loci, traction of our launch efforts will be delayed in the US and Europe due to the COVID pandemic. While our product revenue is not what we had hoped for, we had the chance to welcome exceptional talent into this group. With Paul Tausch, we added strong commercial leadership from Thermo Fisher, Paul has been leading the success of One Lambda with Dr. Terasaki for over 25 years. Turning to our operations, we continue to adapt to a dynamic COVID environment in transplant centers, hospitals, and even within our own facilities. We have established internal operating solutions to protect our employees and their families while continuing our commitment to supporting patients. Despite COVID affecting many large cities across the United States, I'm pleased to report that we have continued our operations without interruption. We are firmly committed to our mission, and we never wavered from our commitment to prioritizing patients. With respect to our ongoing clinical studies, as one would expect, we did see a slowdown in enrollment in OCRA during the second quarter. However, we experienced an increase in short. and utilization of heart care as many centers have switched their biopsy protocols to non-invasive surveillance. Our heart franchise has been exceptionally strong in the second quarter and the value proposition of our precision medicine solution has never been clearer. In the second quarter, we recorded our first ever allocell revenue. While it was only a small amount of revenue, it clearly demonstrates the next step in expanding our transplant technology from solid organs To pursue this, we have built an exceptional team with strong business development hires as well as elevating internal talent. While we are in the proof-of-concept phase, we have fielded many inquiries from pharmaceutical and biotech companies of all sizes. We are very excited about the opportunities in cell therapy and we will continue to update you on our progress. Finally, turning to the balance sheet. The second quarter saw a significantly strengthened our cash position. We closed the quarter with $211 million of cash following a very successfully executed public offering in June. Mike Bell and the team have done an exceptional job. We feel we now have the right size balance sheet to continue to accelerate our revenue growth and take full advantage of opportunities available to us. Before I turn the call over to Mike, I would like to take this opportunity to thank our employees again. We are firing on all cylinders. We provide our services to more transplant patients every day. I'm very confident the best is yet to come. As you can tell, I'm optimistic about the remainder of 2020 and look forward to providing updates on the progress in future communication. Now I'll hand over to Mike to discuss our financials. Mike. Thanks, Peter.

Disclaimer

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