Peter Maag
Analyst · Piper Sandler. Please proceed with your question
Thanks, Greg, and good afternoon, everyone. I'm pleased to welcome you to the CareDx call reviewing our results for the fourth quarter and full year 2019. Before we dive into the results, I wanted to highlight Robert Montgomery. Many of you may have seen the news flow on Rob, a kidney transplant surgeon who recently received a heart transplant himself. Rob is not only using AlloMap and AlloSure for his heart transplant surveillance, but he will also be speaking at the upcoming CIAD conference and introduce our immune optimization study called Kira [ph]. It is for patients and clinicians like Rob that we at CareDx are coming to work every day. Together with the transplant community, we have built a tremendous platform in transplantation over the last 20 years. Now turning to results. 2019 was a very exciting year for CareDx as continued momentum for our high-value healthcare solutions for transplant patients and caregivers drove robust revenue growth. Our full-year revenue was $127.1 million, representing 66% growth over the prior year and clearly exceeded our most recent guidance range of $124 million to $125 million. For the fourth quarter of 2019, total revenue was $35.8 million, increasing 52% compared to the year-ago quarter. The majority of the growth in the quarter came from our Testing Services revenue, which increased 55%. Product revenue for the quarter was $5.1 million and digital revenue added $1.6 million to the top line. With us again posting positive adjusted EBITDA in the fourth quarter, we feel very comfortable about the execution of our plan to build a powerful platform in transplantation. CareDx has never been stronger. Digging deeper into our Testing Services for the fourth quarter, CareDx provided 14,055 AlloSure kidney and AlloMap heart results to transplant patients in the quarter, growing 63% from the 8,632 result in Q4 2018. Since launch in October 2018, over 150 centers have provided AlloSure results to their kidney transplant patients. By end of 2019, over 30 transplant centers in the United States had adopted an AlloSure testing protocol into their standard of care. We are pleased to announce that enrollment in our kidney allograft outcomes AlloSure registry, or K-OAR, study is nearly completed. We have a total of 55 centers in the study The study called for 1,500 patients to be monitored using our AlloSure protocols of 15 tests over three years. So for the next three years, the study centers will continue to observe transplant patients for kidney allograft issues and patient data will continue to be mined for vital insights driving the field over. Just recently, we announced that the American Journal of transplantation accepted for publication a paper titled high levels of donor derived cell-free DNA, identifies patients with T-cell mediated rejection 1A and borderline allograft rejection at elevated risk of graft injury. Based on the data presented in this paper, which shows AlloSure's ability to discriminate the clinical relevance of T-cell mediated rejection or borderline biopsies, we believe AlloSure will ultimately change how clinicians care for transplant patients who have ambiguous rejections based on biopsy [indiscernible]. This study may help define the term liquid biopsy for transplant medicine. Turning to our OKRA study. OKRA stands for outcomes of Kidney Care in renal allograft. We began enrolling patients in September 2019 and enrollment continues to ramp nicely. As a reminder, this multi-center prospective observational clinical trial is designed to measure outcomes of kidney transplant recipients managed with Kidney Care, the combination of donor derived cell-free DNA using AlloSure, gene expression profiling using AlloMap and prognostic graft assessment using iBox. The OKRA study is designed to ultimately include 4,000 patients, adding in our previous multi-center prospective study. This gives us an extensive and in-depth set of patient outcomes. Over the next five years, we expect significant data and findings from K-OAR and OKRA. These findings will not only be published in peer-reviewed journal, but will ultimately lead to changes in the way patients are medically cared for after transplantation. For example, based on the analysis and data of the first 7,000 K-OAR samples and the recently published TCMR data, we were able to identify clinical relevance of AlloSure between the 0.2% and 1% level, which is very exciting since these new insights can directly impact clinical decision-making. Now shifting to heart. AlloMap Testing volume grew solidly in the fourth quarter. Heart care, the combination of AlloMap and AlloSure Heart gained great traction in the cardiac transplant community. This traction might be driven by our ongoing surveillance heart care outcomes registry or SHOR. As of December 31, 2019, we had recruited 39 centers into the SHOR study. In the fourth quarter, product revenue increased 10% compared to the year-ago quarter. We expect our two recently launched products AlloSeq cell-free DNA and AlloSeq Tx, which created a lot of enthusiasm at our global beta sites to start to generate revenue in 2020 and to help drive growth and global expansion this year and beyond. Revenue from our digital solutions was $1.6 million for the quarter. This revenue was generated from our software solutions, which are used in 84 transplant centers in the US, many of which have also adopted AlloSure, AlloMap or both. Over the next year, we will continue to expand our digital offerings including further embedding our AlloSure protocol into transplant center in our platform. I want to take a few minutes to briefly summarize 2019 and offer some thoughts about 2020 and beyond. I'm very proud of the numerous successes our team has had over the past 12 months. As we continue to advance CareDx as a true transplant company and as an essential partner to transplant patients and caregivers. In 2019, our clinical and marketing teams were very busy attending and presenting data at eight industry conferences. At the American Transplant Congress in June, we showcased 12 abstracts and hosted an incredibly well attended lunch symposium which included presentations from seven prominent leaders in Transplantation. During the lunch symposium, we formally announced Kidney Care, the combination of our clinically validated AlloSure testing with AlloMap kidney and iBox, which will deliver personalized and prognostic solutions for transplant patients. According to many of the clinicians that attended our symposium, they not only see value in identifying when there might be an issue with a transplant patient, but also the possibility of optimizing immune suppression in a subset of patients. As many of you know the side effects of immune suppressants are not trivial. For example, they carry the severe risk of infection. We strongly believe that the ability to personalize the approach to immune suppressives will lead to better outcomes and quality of life for transplant patients. With this approach, CareDx promises to bring precision medicine to the transplant clinic. This past November, we had a significant presence at the American Society of Nephrology Kidney Week. We had three abstracts represented on the utility of AlloSure as a surveillance tool and as a marker of allograft injury. As with all of the conferences we attended, participant turnout at our booth podium presentations and symposium was exceptional. 2019 was also a productive year for our regulatory and reimbursement team as we received regulatory approvals and reimbursement wins for both AlloSure and AlloMap. In February 2019, AlloSure became available under a compassionate use program for lung transplant patients. In May, Anthem Blue Cross of California and 10 of its affiliated health plans designated AlloMap Heart as a contracted service. With this change, approximately 80% of all insured lives in the US are now covered for AlloMap. In August, AlloSure received a positive draft local coverage determination for Medicare coverage in heart transplant patients, demonstrating the value AlloSure can bring to transplant patient care. We expect MolDxwill make a final coverage decision about AlloSure Heart in the second quarter, followed by pricing in the second half of 2020. In October 2019, Blue Cross Blue Shield South Carolina became the first private payer to issue a positive coverage decision on AlloSure Kidney, and we will continue to work hard to extend coverage to even more patients in 2020. Finally in November, we further advanced transplant patient care with the launch of AlloSure 3.0, our next iteration in continue transplant patient focused improvement. This latest version of AlloSure provides better care with only one tube of blood required, better science with the lowest limit of detection now at 0.12% and better insight by stratifying patients with T-cell mediated rejection. On the business development front, we furthered our commitment to the Transplant community by acquiring OTTR, a leading provider of organ transplant patient tracking software and XynManagement a supplier of solutions to simplify transplant quality tracking and wait list management. We also entered into a partnership with Civil Tech [ph] for it's iBox technology, a data analysis tool that provides an early prediction of an individual risk of allograft rejection and transplant law [ph]. We believe these transactions will not only expand our direct patient reach but they will also deliver vital analytics to those providing care to transplant patients. Last but certainly not least, in September, our commercial team launched AlloSeq Cell-free DNA, our kit based donor derived cell-free DNA surveillance test and AlloSeq Tx, the first of its kind Next-generation sequencing HLA typing solution utilizing hybrid capture technology. Now looking ahead, 2020 should be even more exciting as our pipeline is full, our clinical studies are enrolling quickly and providing robust data and we continue to enhance our digital offering. In 2020, we have several opportunities to continue our rapid growth. First and foremost is the continued adoption of AlloSure Kidney with only 4% penetration of this very large and growing market, we are still at the early stages of adoption. With heart, we anticipate seeing continued adoption of surveillance protocols for heart care and expect Medicare coverage of AlloSure Heart later in the year. With our product business, we are excited about our newly launched AlloSeq Tx, and AlloSeq Cell-free DNA product and our ability to accelerate our business overseas. 2020 will also see [indiscernible] into stem cell and cellular therapies with our AlloHeem [ph] and AlloSeq HCT offering. Finally, we plan to expand our digital offerings by launching AlloCare, our tool for kidney transplant patients which will be aimed at improving and enhancing patient engagement. Everything we do at CareDX has one focus, and that is to be the leading partner for transplant patients and the transplant ecosystem. With leading the honor of the gift campaign CareDX is supporting the community in extending Medicare coverage for immune suppressive medication. Overall, we continue to receive positive news from HHS and the kidney health initiative. It is great to see Transplantation being the news and even being singled out in the residential addresses, and maybe more importantly healthcare budget. Community nephrologists, large dialysis providers and the transplant community are coming together to increase the number of kidney transplants. It has never been a better time for CareDx to be a transplant focused company. With that, I will turn the call over to Mike to discuss our financials and 2020 guidance.