Waleed Hassanein
Analyst · Morgan Stanley
Thank you, Greg. Good afternoon, everyone, and welcome to TransMedics second quarter earnings call for 2019. Joining me today is Stephen Gordon, our Chief Financial Officer. Our Q2 results continued the positive momentum that we've experienced in Q1. Let me highlight the 4 drivers of this momentum. First was revenue. We reported $5.7 million net revenue for the quarter. This is off of $6.2 million of gross revenues. This represents an increase of 94% versus the same period last year. Our revenue growth was fueled by our U.S. programs on all 3 organs: OCS lung, heart and liver. Second, the OCS Lung U.S. commercial status. We're encouraged by the pace of the commercial conversion of U.S. lung centers in Q2 based on our second FDA PMA approval. As we stated during our first quarter's call, our goal is to convert the majority of the OCS lung centers that were involved in our trials to become a commercial center by the end of 2019. Third, our OCS Liver program or OCS Liver Trial. OCS Liver Trial sustained another high enrollment rate status in Q2, making -- marking the third consecutive quarter of increasing enrollment and clinical use of our OCS Liver System in the U.S. Fourth, our OCS Heart program. The OCS Heart program is ramping up nicely in the U.S., and we expect this program to continue to contribute to our sequential growth on 2 fronts: first is the OCS Heart EXPAND continued access protocol or CAP; and second, in the form of the U.S. DCD heart program that we are anticipating to start enrolling in Q3 of 2019. Looking forward, as we've experienced in some previous years, our third quarter performance could be impacted by summer vacations that may slow down transplant activities in some geographies. However, we believe that the breadth of our 3 programs and our -- and operating geographies should limit our exposure to this issue. Importantly, based on our confidence in our commercial and clinical adoption team and our financial performance in the first half of 2019, we are reiterating our 2019 net revenue guidance range of $23.5 million to $25.5 million for the year, which represents an annual growth rate anywhere between 81% to 96%. Now let me share with you some key highlights from the second quarter and discuss our 6 priorities -- or discuss the 6 highlights from Q2 and the priorities for the second half of 2019. First, on June 3, we announced that our OCS Lung System received its second FDA PMA approval to include not only standard lung preservation but also to assess and preserve the larger pool of expanded criteria donor lungs from either DBD or DCD donors. That approval strategically positions the OCS Lung technology as the only technology approved for both types of donor lung for transplantation in the United States. No other technology has this combined indication in the U.S. or frankly around the world. Two, the second PMA approval that we talked about here for the lung approval, helped us -- helped alleviate any residual confusion regarding the OCS Lung clinical indication in the U.S. We now expect the adoption process to become more efficient and more streamlined. We saw this transition begin to pan out in Q2, and we expect the process to continue through Q4 of 2019. This process includes additional team member training of these institutions, IRBs for data collection in the post-market registry and addressing any internal center logistics, reimbursement or billing questions specifically related to new centers that didn't have the billing processes established prior to joining our commercial program. The next point is leveraging this PMA approval. In Q2, we initiated a new pilot program using the Organ Care System Lung to retrieve, optimize and assess donor lungs that were initially deemed unaccepted for transplantation due to time and distance limitation of cold storage. We announced last week the successful transplantation of 2 patients, 1 in North Carolina and 1 in Arizona, after they received donor lungs retrieved from Hawaii. Both donor lungs were retrieved and managed by TransMedics surgical and clinical teams using the OCS Lung System. They delivered the donor lungs through the OCS to the transplant center for final assessment prior to transplantation. As we stated in our press release, this is a significant milestone not only for our OCS technology but for the entire field of organ transplant. We plan on continuing and expanding this program to facilitate utilization of the OCS System and overcome logistical barriers to increase donor lung utilization in the U.S. The next area I want to highlight is relating to our OCS Liver PROTECT Trial. As I stated earlier, Liver PROTECT Trial has achieved another record enrollment rate in Q2 with 245 patients of the initial target 300 patients has been enrolled as of June 30. As we sit here today, we're at 258. We submitted our plans for the prespecified sample size re-estimation to FDA for their final approval before we conduct the statistical test. We are interacting with the FDA to address their questions while they assess if the process will be necessary or not. If FDA approves our plan, we will have an independent biostatistician conduct a prespecified sample size re-estimation in late Q2 or early Q4 to evaluate if additional patients are needed to meet the OCS Liver Trial objective. We would like to reemphasize that no other data or results will be shared by these biostatisticians to the company or any member of our operating team. We intentionally did this to ensure and preserve the integrity of the PROTECT Trial. We hope to provide more color about this particular process during our Q3 earnings call. Now let's move on to our International business. In Q2, we saw a slight decline of approximately $200,000 year-over-year, of which 50% or $100,000 were due to currency fluctuation. We expect this to recover in H2 2019. On another front, we are delighted to report that the first reimbursement code in Europe for ex vivo perfusion of DCD lungs were achieved -- was achieved in France in Q2. We hope this will open up the door to facilitate additional reimbursement codes in the future. Further, we are actively engaged with NHSBT in the U.K. and the German Ministry of Health in Germany to discuss reimbursement, budgets and processes and codes for OCS heart, lung and liver. As we stated before, these are long-term initiatives that we should -- that should mature over the next 18 to 24 months and will provide or should provide growth for the business at that time horizon. We're encouraged, however, by the tangible momentum shift towards accepting machine perfusion for transplantation in Europe. Next, let me turn into the OCS Heart program. We had a busy Q2 with the initiation of the continued access program or protocol. We expect the U.S. DCD program to start enrolling in late Q3, early Q4, which will further facilitate increased use of the OCS Heart System in the U.S., while we're waiting for the PMA approval. Regarding the heart PMA, we are in the final stages of filing our complete and final responses to all FDA's questions. We hope to engage with FDA very soon regarding the scheduling and the date for the potential advisory panel meeting. While the timing of a potential OCS Heart panel is unknown at this point, we are proceeding and planning all of our plans to prepare the company to be ready for a possible panel date in Q4 this year, if that occurs. I would like to spend a couple of minutes in the conclusion of my section of this -- of the presentation to provide our physicians on some misinformation and factually inaccurate statements about the OCS Lung EXPAND Trial and the new FDA PMA indication. These statements were made public by a competitor during their Q2 call in response to analyst questions. I hope that the fact that I'm going to share with you correct this confusion once and for all. One, the EXPAND Trial used a well thought-out clinical indication that best define the types of donor lungs from DBD or DCD donors that initially may be deemed not suitable for transplant because of the limitations of cold storage. Two, the results of the trial clearly showed that we used lungs that were rejected for transplantation by other centers on average 35x before being accepted by an OCS Lung Trial center to be assessed in the OCS System. Three, as per the results that were published in the recent Lancet paper that was published online on August 1, the utilization rate achieved in the EXPAND lung study of 87%, to our knowledge, is the highest ever reported in the history of lung transplantation. Specifically, as The Lancet paper underscores, it is significantly better than the 23% utilization rate achieved using cold storage in standard lungs as well as significantly better than the 51% utilization rate reported in the scientific literature using the nonportable competitive perfusion set up from Sweden. Four, the current OCS Lung System's FDA approval or approved indication for use is crystal clear. It states that the OCS Lung can be used for ex vivo assessment of donor lung function. The Lancet paper is posted in our website, and the FDA approval letter or approval order is available on the FDA's website. With that, I will turn the call to our CFO, Stephen Gordon. And then I will return with some closing comments.