TransMedics Group, Inc.

Good afternoon, and welcome to Transmedic's first quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Brian Johnson from the Gilmartin Group for a few introductory comments. Thank you.

Earlier today, Transmedics released financial results for the quarter ended March 31st, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call, including during the question and answer portion, that include forward-looking statements within the meaning of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation, are examination of operating trends, the potential commercial opportunity for our products, and our future financial expectations, which include expectations for growth in our organization and guidance under expectations for revenue, gross margin, and operating expenses in 2023 are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, You should not place undue reliance to these statements. Additional information regarding these risks and uncertainties appears under the heading Risk Factors on our Form 10-K filed with the Securities and Exchange Commission on February 27, 2023, and our subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov and on our website at www.transmedics.com. Transmedics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 1st, 2023. And with that, I'll turn the call over to Waleed Hassaneen, President and Chief Executive Officer.

Thank you, Brian. Good afternoon, everyone, and welcome to Transmedics' first quarter 2023 earnings call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. Since our last update, we have continued building on our strong 2022 performance, making progress on many of our previously outlined growth goals for 2023. I'm thrilled to report that our first quarter results demonstrated significant commercial momentum and accelerated clinical adoption through the Transmedics NOP. Importantly, In Q1, we also made progress in scaling our supply capacity of our OCS perfusion modules. Here are the top-line results. In Q1, we achieved total revenue of $41.6 million, representing 162% year-over-year growth and 32% growth over 4Q 2022. As predicted, NOP continued to be the primary driver for our revenue growth. a trend we expect to continue for the foreseeable future. Importantly, we also demonstrated continued improvement down the P&L as we benefited from increasing operating leverage, which Stephen will detail in his section of today's call. Before I move on to discuss the 1Q details, I would like to take a moment to mention that Transmedics has released our first annual ESG report, which was published this morning on our website. Now, let me move on and provide some more granular highlights on 1Q 2023. Overall, 1Q represented another new high watermark for case volume, driven by liver and heart cases, which increased sequentially for the fifth consecutive quarter. Meanwhile, lung volumes continued to lag as we worked to help rebuild this very important market. In line with our outline growth strategy, we also grew the number of liver and heart transplant programs using OCS and NOP. There were 32 liver programs that used OCS and NOP in one cube, of which 15 were active repeat users. For heart, there were 40 programs that used OCS and NOP, of which 11 were active and repeat users. There were nine lung programs that used the OCS and NOP, of which six were repeat users. We're not concerned by the lung-centered trend given the small numbers and our previous guidance that our initiatives will take approximately 12 to 18 months to materially impact lung program growth. In terms of the NOP contribution, approximately 91% of our total U.S. case volume came from NOP. On a per-organ basis, approximately 96% of liver, 83% of heart, and 91% of lung cases were from NOP program. We view these NOP penetration rates as very encouraging and in line with our goal of having Transmedics NOP managing the lion's share of U.S. transplant volume over the next several years. In 1Q, we also began to increase production and sterilization capacity. The increase was driven primarily by the scaling of our second shift in our operational existing cleanroom. We expect to see further gradual capacity expansion as we bring our new cleanroom online and fully operational. Given that we received FDA certification of our new cleanroom in one queue, we are confident that the timeline for the new cleanroom to be operational remains on track for late Q2. Our 1Q results clearly demonstrated the fast pace of growing clinical demand for our OCS technology and the NOP service model. We remain laser focused on bolstering our supply chain and NOP infrastructure to sustain and further accelerate our growth. Let me outline our key focus areas to keep up with this accelerated demand, specifically on OCS production availability and NOP infrastructure capacity. So first, production and product availability. As mentioned, we're continuing to invest in our manufacturing capacity and supply chain to ensure continuous product availability. More specifically, we are enhancing production and sterilization capacity, as well as raw material supply chain management. For production and sterilization capacity, As stated, we are on track to bring our new clean room production space online by mid-year, but we are not stopping here. We have already secured additional new space in our current facility to support the increased production build, as well as raw material and finished goods inventory growth. In addition, we are working with specialized third-party workflow optimization experts to revamp our production process workflow to maximize efficiencies within both clean room spaces. Lastly, we are significantly increasing our sterilization capabilities by qualifying a brand new major sterilizer while working to expand the capacity and the throughput of our current sterilization partners. this expanded sterilization capacity will be online in H2 2023. For raw material management, historically, we've never had a raw material shortage. However, as we are significantly increasing our production capacity to meet the growing clinical demand for OCS technology, we have established a new dedicated raw material planning and monitoring team within our operations team. This new team This new team's function is to establish a scalable process to closely track our growing demand for raw material and proactively replenish our raw material to meet our near, mid, and long-term needs. Second, we'll continue to expand our NOP infrastructure. Specifically, we will grow our surgical and field clinical staffing throughout the next 12 to 18 months, to meet the growing demand for the NOP clinical services across the U.S. We are also planning to opportunistically add two to three new launch points later this year to expand our coverage and reach larger pools of potential donors faster and more efficiently. Next, we will revamp and scale the logistical management of the NOP case flow. we have recruited a senior logistics executive from Amazon to lead our initiative to streamline, scale, and digitize the entire logistical workflow of our NOP program, literally starting from the initial transplant center's call to the NOP hotline through the organ arriving at the transplant center. One key feature of this exciting new initiative is creating a digital central command and control and dispatch center. I'm sorry, creating a digital central command control and dispatch center here in Andover to oversee and manage our national NOP workload. We hope to start sharing more granular detail on this exciting initiative towards the end of 2023. Additionally, We announced at ISHLT in April that we are planning for the launch of our customer-facing portion of the Transmedics OCS Connect application. This is a secure and HIPAA-compliant app that will provide surgeons and clinicians with real-time updates on the overall status of the organ on OCS, as well as logistics and travel time information. It will also enable secure real-time communication of case information between our team managing the organ and the transplant program clinical staff. We are very excited about this new function of our OCS Connect, and we hope it will provide more transparency and confidence to our users about the status of their organs en route to the transplant center. Finally, and as we have stated several times, We fully intend to eventually control the entire air and ground transport function for the NOP transplant cases. This will help remove a critical bottleneck for our growth. We are seeing our NOP volumes are starting to outpace the capacity, the availability, and flight radius of the fragmented transplant air charter model that we and the transplant programs are using today. We also announced at ISHLT that we expect to launch this important transmedics aviation initiative sometime in H2 2023. We are actively engaged on several fronts to establish a national dedicated NOP transplant charter flight network to cover our existing and potential new hubs. I'm looking forward to discussing this exciting initiative further in the latter half of this year. In the meantime, please allow me to take this opportunity to discuss in detail and clarify the current way of air transportation for organ transplants in the United States. To start, it is important to recognize that all, I repeat, all air transport for hearts, lungs, and liver transplants in the United States are transported via charter flights. These flights costs are a part of the organ acquisition cost center and are an allowed charge for the CMS cost report. All commercial transplant payers and CMS routinely reimburse these costs. Historically, when organ transport was limited to a short distance within the donor service area, or DSA, of the involved organ procurement organization, or OPO, The OPOs were the main flight coordinators for the transplant programs. Consequently, a few OPOs purchased their own short-range aircrafts to manage local travel. Back then, more than 90% of donor organ allocation came from the transplant program's local OPO DSA, literally less than 250 miles. And only less than 10% came from outside of the local DSA. Today, the reality is the complete opposite. Let me explain why and how. Approximately five or six years ago, organ allocation for lungs, hearts, and liver transplants shifted from regional to national allocation in the United States. This effectively means that a donor in San Francisco can and should be allocated to the matched recipient in Boston or New York or Raleigh-Durham, North Carolina. With that change, the rate of organ acceptance by nearly all the leading transplant centers flipped overnight to more than 90% national or distant allocation and only less than 10% local allocation. This led to many OPOs selling their jets and shifting most of the responsibility, if not all the responsibility, of air transport coordination back to the transplant programs. To make this more interesting, between 2020 and 2022, the OCS technology became FDA approved in the United States, and the NOP was established. This shift led to a very important shift in the United States organ placements because the OCS enabled safe, longer distance procurement across the entire country and from outside the continental U.S., like Hawaii, Alaska, Puerto Rico, and Canada. So how do transplant programs coordinate their organ transport charter flights today? They rely exclusively on a few regional charter flight brokers who owns no jets or even have the license to operate a charter flight. Those charter flight brokers rely exclusively on the third-party owners and operators of charter flights. This is a very cost and operationally inefficient way of running organ transplant transportation and will become a major bottleneck for NOP growth going forward. This antiquated fragmented approach is not geared to the distances that we are now covering, the volume of donor organ missions that we do on daily basis using NOP, or the volume expected in the near and long-term future. Importantly, many of the jets used today are older vintage with very limited flight range and lacks Wi-Fi communication capabilities. We saw firsthand in 2022 the massive cost inefficiencies that exist in the current model, and we believe Transmedics managing our own logistical network will create value for our clinical users, their patients, and other critical stakeholders in organ transplantation in the United States. We believe strongly that securing this dedicated national network of charter flights under Transmedics Aviation would act as an additional significant catalyst for the growth of NOP and transmedics business in the United States. Again, I hope to share more details as we get this initiative operational later this year. There's no doubt our OCS technology and NOP service model are driving a transformative shift in organ transplantation in the United States. as demonstrated by our first quarter performance and strong growth trajectory thus far. It is important to note that we strongly believe that this is only the beginning. We are not stopping or slowing down. We have bigger goals in mind, and we fully intend to execute on our strategy to achieve sustained long-term growth for our business. We remain laser-focused. on execution and navigating this steep growth curve to drive continued success. As I've done in the past, I would like to share with you all what we see as the potential challenges that could temporarily impact our growth trajectory for the remainder of 2023. First, constraints on our supply chain and production capacity. As stated earlier, we need to be cognizant of our demand for raw materials as we increase production capacity. Though we do not currently foresee any issues, we could face some delays regarding some parts availability or obsolescence issues that could temporarily hamper our immediate term growth. Second, clinical NOP staffing delays could limit our ability to cover new regions hubs temporarily until we resolve it. Delays in securing our logistical network and air transport could temporarily slow us down later this year and into 2024. That said, given our strong 1Q23 results and increased confidence in the trajectory of our finished goods supply, balanced with potential scalability challenges above, We are increasing our annual revenue guidance for the full year 2023 to be between $160 to $170 million, up from our previously communicated guidance of $138 to $145 million. This new guidance represents 71 to 82% growth over full year 2022 total revenue. With that, let me turn the call to Stephen to cover the detailed financial results for the quarter. Stephen?