Waleed Hassanein
Analyst · JPMorgan. Please go ahead
Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics fourth quarter and full year 2022 earnings call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. Our fourth quarter performance demonstrated continued commercial momentum and accelerated clinical adoption through the NOP, despite constrained supply of our OCS perfusion module, as we are working to increase finished goods assembly capacity. This marks another quarter of significant sales growth for the business. Here are the summary results. 4Q total revenue was $31.4 million representing 225% year-over-year growth, and approximately 22% growth over the third quarter of 2022. As expected, NOP continued to be the primary driver for the revenue growth at trend we expect to continue for the foreseeable future. Total revenue for the full year 2022 was $93.5 million, including new products and service revenue of $92.1 million and $1.4 million favorable contour revenue adjustment in 3Q. These results represent 209% and 204% year-over-year growth respectively. We effectively tripled our revenue in 2022 over 2021. Stephen will cover the financial details and organ split in his section of this call. Now, let me provide some more granular highlights on the quarter and the full year. Overall, 4Q represented a high watermark for case volume for OCS and NOP. As heart and liver cases increased sequentially for the fourth consecutive quarter, we were also pleased to see modest but encouraging growth of lung activities in Q4, a trend which we hope to maintain in 2023. Approximately 89% of our total U.S. case volume came from NOP. On a per organ basis, approximately 97% of the liver, approximately 79% of the heart and approximately 85% of the lung cases were from NOP. 2022 has demonstrated to us that NOP is here to stay and is uniquely differentiating TransMedics in the marketplace. Our goal is to drive NOP to be the new standard of care for solid organ transplant in the U.S. over the next several years. As we predicted and despite being in the first year of commercial launch of OCS, liver and heart in the U.S., the overall transplant market saw modest overall transplant volume growth year-over-year. Liver transplant grew by approximately 3%. Heart transplant grew by approximately 9%, and even lung were up approximately 7% in 2022 over 2021. We believe this is an encouraging early sign that the use of OCS and NOP are enabling growth in the overall transplant volumes in the U.S. through the use of DCD, extended criteria and distant donor in the U.S. Simply stated the OCS and NOP are fundamentally growing the transplant market. We will continue to track this annual trend and we expect to see these growth rates to increase over time with NOP growth in all three organs. We ended 4Q 2022 with critical mass of transplant program using OCS and NOP. There were 22 liver programs that used OCS and NOP in Q4, of which, there were 12 active users. For heart, there were 29 programs that used OCS and NOP, of which 12 were active users. In lung, there were 13 programs that used OCS and NOP, of which, five were repeat users. It is important to note we have achieved the above results despite being in a supply constraint situation for several weeks during 4Q. As we continue to build up our production capacity to meet the growing demand for OCS, we were able to navigate this difficult situation, grow our case volume, and grow our revenue by leveraging the NOP hub network to supply OCS modules to any location across the U.S. to meet the demand using charter flight. This early inefficiency in the supply chain distribution was the primary driver of the 4Q service margin erosion, since TransMedics have to absorb these costs to meet the demand. We expect this to be a transient phenomenon and that this will revert once we scale our production capacity and develop more leverage on the logistical process. Let me use this opportunity to update you in several actions that we’ve taken to enable us to overcome the production capacity constraints over the coming several months. We’ve already expanded our clean room space. The documentation for FDA certification is under review by FDA and we are expecting the certification or FDA decision over the coming months. We are expanding our existing sterilization capacity and are in the final stages of qualifying a larger sterilization partner to expand total capacity and further de-risk our supply chain. We have staffed a second assembly shift that is now fully operational. Importantly, we’ve brought on Nick Corcoran, who have served in multiple roles of increasing responsibilities at Stryker Corporation as our Senior Vice President of Supply Chain and Operations to lead these initiatives as we continue to scale. In summary, we expect to resolve production capacity constraints by the second half of 2023. There’s no doubt in our mind that 2022 was a transformative year for TransMedics business as we demonstrated the significant value proposition and growth potential for OCS and NOP in the United States. We strongly believe, however, that this is just the beginning of a long runway of sustained significant growth for TransMedics business. Let me articulate our strategies to achieve our growth potential. First, starting in 2023 and as soon as we adequately enhance production capacity, we will focus in four areas to grow our U.S. transplant franchise further. Specifically, we will continue to add new transplant programs to the NOP initiative in the U.S. for liver, heart and lung. We will drive deeper penetration with an existing and new transplant programs based on the demonstrated efficiency and clinical outcomes of OCS cases at these programs. Focus on growing the overall transplant volumes at these programs from DCD extended criteria and distance standard donors using the NOP infrastructure. Finally, reinvigorating the OCS lung program through the NOP in the U.S. to contribute additional growth. Second, we will continue to expand our NOP infrastructure. Specifically, we are expanding our surgical capabilities and clinical support staff across the board and maybe opening new launch points as needed to expand our geographical reach in the U.S. Third, we are developing a best-in-class dedicated air and ground logistics network for organ transplantation in the United States. This is critical. Let me repeat, this is critical to managing our growth potential and controlling our transportation costs and improving our service margins. Importantly, we strongly believe that this initiative would create a significant catalyst for further growing the NOP franchise in the U.S. Importantly, it will create a larger, deeper and wider more around our NOP offering, while uniquely positioning us to more fully transform the standard of care in the United States. Finally, by continuing to invest in our next-gen OCS and next organ programs. This is critical to our long-term growth, importantly, to further distance ourself from any potential competitors on the horizon. Let me conclude this section by sharing some important facts to help quantify the magnitude of growth in front of TransMedics that we are planning to fully capitalize on. In 2022, we transplanted approximately 1,000 cases on OCS. This represents only 7% of the existing total U.S. liver, heart and lung transplants in 2022. We strongly believe that we have the potential and are creating the NOP infrastructure to be able to perform the lion share of the existing U.S. transplant volumes for liver, heart and lung transplants. In addition, we are – we also expect to benefit from our ability to grow the overall transplant volumes as we have demonstrated early on in 2022 by enabling the use of organs from DCD, extended criteria and distant standard criteria donors that were seldomly utilized for transplantation in the U.S. due to the limitations of historical procurement and preservation methods. This is effectively will grow our total addressable market opportunity for TransMedics and organ transplantation. In all, we are humbled and thrilled by our successes in 2022. And we're looking forward to continuing to build on this solid foundation to catapult TransMedics to new heights in 2023 and beyond. We are confident in our strategy and we are laser focused on execution of our plans to drive the next gear of growth for TransMedics and NOP. As mentioned, 4Q results continue to outpace our forecasted demand plans and challenge our finished goods production capacity. As we stand today, we foresee this issue continuing with us until probably the end of Q2, which may be impacted by a temporary shortage of supply of finished OCS products in immediate term. During this ramp up process, we may find ourselves in another back order situation in Q1 or Q2 2023. That said, based on our 4Q and full year results and balancing these results with the expected finished goods pressures in H1 2023, we are setting our annual revenue guidance for full year 2023 to be between $138 million and $145 million in revenue, representing a strong 50% to 57% growth over 2022 total revenue excluding contra revenue reversal. With that, let me turn the call over to Stephen to cover the detailed financial results for the quarter.