Peter Maag
Analyst · Piper Jaffray. Your line is now open
Thanks, Caroline. Good afternoon everyone. I’d like to begin with a patient focused snippet as we do on all of our calls. Paul Conway visited CareDx in the second quarter. He is a kidney transplant recipient who have managed its kidney disease for over 34 years. Paul was Agency Chief of Staff at the US Department of Homeland Security. As you think about the security that TSA provide, please think of him. But more importantly, Paul has made it his mission to support fellow kidney transplant recipient. He is now heading the American Association of Kidney Patients as their President. Paul has taken more than 125,000 tablets since his transplant. At CareDx, our goal is to help patients like Paul to receive personalized care, facilitate compliance, and reduce this mind-boggling number of medications. In our agenda for today, I'm now going to provide a summary of our recent performance highlights, focusing on our core and on our launch products in both our pre-and post transplant efforts. I'll then ask Charles to dive deeper into our second quarter financials and then we look forward to your questions. Now let me update you on some of the progress we’ve made at CareDx. It is exciting to be reporting our first greater than $10 million revenue quarter. With $10.7 million, we have had a strong quarter driven by AlloMap U.S volume growth of 12%, an uptick on collections and the integration of the Olerup business into our P&L. This performance demonstrates our execution against the three objectives stated during our IPO. The first one was core AlloMap, second develop a cell-free DNA surveillance solution for transplantations, and thirdly add to our scope and capabilities through external growth. At the end of my update, I will speak about some of our future goals now that we have significant presence in both the pre-and post transplant segment as well as having broadened our reach to transplant centers worldwide. We see growth in our core business as a foundational element for CareDx. We have two substantial core products and both our leaders in their respective fields. Our core product in post transplant is AlloMap, a gene expression based heart transplant surveillance testing service. In the second quarter, we provided approximately 3,600 AlloMap patient results translating into U.S volume growth of 12% in the quarter over the previous year. We continue to focus on the rollout of AlloMap score variability, a tool that tracks the variation of AlloMap over time. On supporting the establishment of protocols in transplant centers and driving adherence to these protocols. Todd Whitson joined the Company as Chief Commercial Officer and is driving our continued focus on providing world-class customer service. We have launched a couple of exciting pilots in which CareDx partners for the transplant centers and support some of the patient logistics. As of the end of the second quarter, they were 65 centers that established AlloMap protocols up by one center. We are excited to have 46 centers that are receiving AlloMap variability scores up from 41 in the previous quarter. And we have now our web portal established at 76 centers up from 63, which provides the first platform of digital interaction and will serve as a bridgehead for future communication and data exchange. As you know AlloMap met CMS reimbursement headwinds recently. In 2016 CMS capsule process AlloMap has received an initial pricing proposal that results in a 74% price reduction. We have outlined a strategy that initially focuses on those local MACs that have despite having experience with AlloMap submitted an acceptable price proposal to CMS. We have no insights into how they determined these price levels and we find it unacceptable that these contractors refused to meet with us to generate a common understanding. While we’ve provided additional information and data, we anticipate that they will resubmit their erroneous proposals to CMS. And then, AlloMap along with other high-value diagnostic tests will go through the reconsideration process. This reconsideration process at CMS is similar to what we went through in the last quarter of 2015 when we successfully demonstrated the rationale for pricing AlloMap at $2821. We expect a final decision this coming November with the release of the 2017 Clinical Lab Fee Schedule. CareDx continues to believe that the inappropriate reimbursement rate of AlloMap will injure patients, devalues evidence, stifle innovation and significantly slows the adoption of physician medicine. Based on the quality of our physician and on our track record, we are confident that we will prevail. It is also important to note that with PAMA regulation established for 2018, the reimbursement pricing will be based on commercial market pricing. Based on this, we believe that under PAMA, AlloMap 2018 reimbursement levels will be similar to our current established reimbursement levels. Now turning our core -- turning to our core pre-transplant Olerup product line. Olerup SSP can be described as the best-in-class TCR-based HLA typing kid across the globe. In Q2, we directly sold Olerup products in more than 130 transplant centers and estimate to cover in excess of 200 transplant centers through our distributor network. Olerup revenues for the quarter were $3.4 million in line with our expectations. In the second quarter, our team in Stockholm also successfully passed an FDA audit without NE483. We also had a small product recall for one of the HLA kid which was handed extremely fast and professionally. The economic impact for this recall was less than $100,000. It has been great to see the combined human action and it became apparent that we have very talented professionals working on both sides of the Atlantic Ocean, augmenting and supporting each other demonstrating that they’ve great synergies between both organizations. In addition to our core AlloMap and Olerup products, Security expert payers two products for launch. We continue to work towards the commissary station of AlloSure, our donor derived cell free DNA surveillance solution to be clinically validated initially for kidney transplantations. AlloSure is a clinical grade next-generation sequencing tests to detect status of transplanted organ injury. We believe AlloSure shows promise to revolutionize post-transplant management and has diagnostic blockbuster potential. The potential market for AlloSure and kidney transplantation is over $1 billion and represent the 6 to 10 fold increase in the total addressable market compared to our existing presence in the heart transplant market. To provide a perspective, we could see our business grow to a $100 million in revenue, in 2019 based on the AlloSure opportunity. We define a diagnostic blockbuster as having an annual potential minimum peak sales of $210 million. We have achieved rigorous analytical validation of the test and share some new clinical data in the second quarter on the American Transplant Congress, in Boston. We believe there's a lot more to come. In June, we reported a positive first analysis from our DART study developed to demonstrate the clinical validity of AlloSure. The DART study is our prospective multicenter observational study where serial blood specimens are drawn from kidney transplant recipients. There are multiple indications that may benefit from information provided by AlloSure. Tasks to reimbursement include seeking Medicare reimbursement either through coverage under data development in the next months with a commitment from the company to an outcome oriented trial to further enhance our clinical plans for a longer-term path -- for a longer-term path to reimbursement following an additional trial. The focus of ROSE, a trial that longer-term outcomes will be to demonstrate further clinical utility and support reimbursement in the Medicare population. Medicare reimbursement is important since 90% of kidney transplantations are covered by Medicare for at least three year post-transplant. We also note that there has driven by our exciting data that some other companies are starting to talk about cell free DNA in transplantation. We see this as validation of the market attractiveness and the potential unmet medical need that be addressed. We believe that competition will benefit -- will be beneficial in building the market and will allow us to communicate the benefits of AlloSure and our transplants tailored approach. In our pre-transplant franchise, we will commercialize Olerup QTYPE in the second half of this year in line with our previously stated plan. Olreup QTYPE is a robust and easy-to-use test for rapid HLA typing via real-time TCR. We expect to update you on QTYPE from the ASHI meeting in September. Here at CareDx we’re thrilled to build a transplantation centric organization. We’ve changed our tagline to CareDx your partner in transplant care. While our commercial focus and performance metrics will continue to depend on patient results and test provided, we will build on our vision. To enhancing our presence and broadening our product offerings, we are architecting CareDx as a genomic information Company in transplantation. You will hear us talk more about how we believe we can capitalize on our prior and ongoing trials and registries. Linked data from our test with individual patients clinical data utilize existing reference databases and contextualize this data for clinicians and patients. Some will refer to this as a big data project in transplantation, we refer to it as building a transplant information ecosystem. To make it simple for you and to summarize the key milestones for the Company, for the second half of 2016, first, maintain Medicare AlloMap pricing. Second, obtain clarity on AlloSure reimbursement and start the ROSE trial. Thirdly, launch Olerup QTYPE and lastly advance our transplant information ecosystem. I will now turn the call over to Charles to review our financial highlights and guidance for the year.