TransMedics Group, Inc.

projections, expectations, predictions, or forward-looking statements, whether because of new information, future events, or developments, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 5th, 2026. And with that, I will now turn the call over to Waleed Hasmeen, President and Chief Executive Officer.

Thank you so much, Hannah. Good afternoon, everyone, and welcome to Transmedics First Quarter's 2026 Earnings Call. As always, joining me today is Gerardo Hernandez, our Chief Financial Officer. Our vision has always been bold and growth-oriented. Since inception, Transmedics has been relentless in our pursuit to transform organ transplant therapy by increasing utilization of donor organs and improving the clinical outcomes of transplant patients through technology and service innovation and by disrupting the status quo. To accomplish this, we've been deliberate yet aggressive in our strategic investment in growth initiatives. We believe that 2026 is a critical and transformational year that stands to cement transmedics near, mid, and long-term growth trajectories and global market position. In the U.S., we're actively engaged in growing our heart and lung franchises by advancing our enhanced heart and de novo lung programs to expand our clinical evidence to support broader adoption. In parallel, We are also completing the development of the OCS kidney platform using our Gen 3.0 platform. Our OCS kidney platform will enable us to access the largest segment of the global transplant market, which is kidney transplantation. This will happen for the first time in the history of transmedics. We strongly believe that once regulatory approvals are in hand, OCS kidney will derive significant growth for our abdominal franchise. And we're not stopping here. We're also actively engaged in upgrading our heart, lung, and liver devices to Gen 3.0 platform, which will enable us to gain significant future operating leverage and increase clinical adoption of the OCS platform in these critical organ transplant segments. Our growth initiatives also now go beyond warm perfusion. We recently unveiled the Transmedics Controlled Hypothermic Organ Preservation System, or TRAPS, CHOPS is designed to expand our product offering to cover new segments of the transplant market best served with cold static storage. And finally, our growth initiatives now extend beyond the U.S. to important international markets. In Europe, we are undertaking a bold initiative to replicate the NOP clinical service and transplant logistics model to catalyze European OCS adoption and potentially expand our total addressable market. I will provide details on each of these exciting initiatives on today's call. As you can see from our ongoing growth initiatives, our focus remains on long-term value creation with continued investment across each pillar of our growth strategy. Specifically, I want to highlight that this is a strategic and proactive decision. And we fully expect that our financial performance over the next several quarters will reflect these necessary investments in people, infrastructure, and technology development as we capitalize on the opportunities in front of us. Based on everything we know today, we are highly encouraged and inspired by what's ahead for Transmedics. We are committed to executing our plan to drive significant growth for Transmedics and for the global transplant markets broadly. As I've stated repeatedly, I truly believe that transmedics remain in the early innings of our long-term growth opportunity. I'm excited to report that our first quarter performance that reflects a strong start for 2026. Despite the broader volatility and the transient negative impact of the U.S. Transplant Modernization Act on OPO performance and the overall donor numbers in the U.S., we managed to deliver a solid quarter to start the year. Here are the key operational highlights for 1Q2026. Total revenue for 1Q2026 was $174 million, representing approximately 21% growth year over year, and approximately 8% sequential growth from 4Q2025. U.S. transplant product revenue grew by 22% year-over-year and approximately 7% sequentially to $102 million, while OUS transplant revenue grew approximately 39% year-over-year and approximately 17% sequentially to $6 million. We delivered an adjusted operating profit of approximately $18.1 million in Q1, representing approximately 10.4% of total revenue in 1Q, while continuing to make significant investment to fuel our growth. Importantly, we ended 1Q with $462 million of cash and cash equivalents, while making substantial investments in the growth initiatives above. Transplant logistics services revenue for 1Q2026 was approximately $32 million, up from $26.1 million in 1Q2025, representing approximately 22% year-over-year growth, and up from $28.6 million in 4Q2025, representing approximately 12% sequential growth. In Q1, we maintained coverage of approximately 82% of our NOP mission requiring air transport. We expect to maintain 22 operational aircraft in the U.S. fleet throughout 2026. As we discussed, we are now focused on maximizing the utilization of our U.S. fleet and improving efficiency and capacity by double-shifting a portion of the fleet to meet the growing clinical demand. We will detail key findings from this initiative at year end. Overall, we are pleased by our strong performance that was fueled by growing OCS cage volume, increased clinical adoption. Importantly, we're also encouraged that we achieve these results without any contribution of enhanced and de novo clinical programs due to the enrollment timing of these important programs. Speaking of enhance and de novo, let me shift to provide a detailed update on our strategic initiative to unlock these two important clinical programs to help us grow our cardiothoracic franchise in the U.S. At the recent IHLT conference in April, we unveiled our transmedics-controlled hypothermic organ preservation system, or CHOPS. CHOPS is a true active cooling device designed to provide a variety of temperature conditions ranging from 4 to 12 degrees Celsius to meet the user's needs. This represents a unique and optimized approach that we believe is superior to the styrofoam boxes that are used for cold static storage of organs today. These boxes use phase-changing material or cold packs that are extremely variable and are nearly impossible to control or adjust preservation temperatures with. CHOPS will be an FDA-registered and regulated organ preservation device made by Transmedics and will serve as the control arm of the Enhance and DeNovo programs once the IDE supplement is approved. This would be a huge strategic win for Transmedics, as it stands to help avoid any reliance on competitive products as we conduct our important clinical programs for heart and lungs. We plan to file the IDE supplement within the next few weeks, and we expect this to be approved and implemented in early Q3 2026. Importantly, In parallel to these clinical programs, we fully intend to file a 510K application to clear this device for commercial use in the U.S. Once cleared by FDA, CHOPs would expand Transmedics' platform of organ preservation technologies and enable us to address shorter preservation times for organs that may be best suited for cold storage. As we highlighted in our last call, The panic and confusion caused by the competitive reaction to our clinical programs somewhat delayed our enhanced Part B and Vinobo enrollment. We not only addressed this challenge by introducing CHOPS, but we are now going after the niche market with superior, more validated cooling technology and our best-in-class NOP infrastructure. Said differently, beyond facilitating our trial enrollment, We are expanding our product portfolio to ensure that Transmedics is well-positioned to provide transplant programs around the world with the widest range of products to meet their clinical needs across the full spectrum of organ transplantation. We plan to accomplish this goal based on best-in-class technologies, best-in-class clinical services, and with the most cost-efficient and reliable logistical network in the market. Now let me move to share update on our strategic initiatives that we see as an important catalyst for our business. First is the National Transplant Modernization Act. In March, 2026, Transmedic submitted our detailed comments on CMS proposed rulemaking language for the new U.S. transplant system to advance U.S. transplant modernization initiatives. Our public comments focused on several key topics. First, on the system-wide benefits of allowing new entities with proper national infrastructure that are not current OPOs to participate in the new transplant ecosystem by becoming either a multi-regional or even national OPOs. This is to help maximize U.S. donor organ utilization for transplants. Importantly, it would provide a mechanism for fair competition and maximize transparency while driving cost efficiency to the U.S. transplant ecosystem. Second, on the benefits of using FDA-approved portable perfusion technologies to maximize donor organ utilization in the U.S., while limiting the use of unproven, fairly expensive, and potentially detrimental techniques that were organically introduced into the market over the last several years. Third, on the benefits of enabling for-profit entities to participate so long as they are strictly adhering to all performance metrics proposed by CMS and complying with all the financial disclosure requirements. Fourth, on the benefits of allowing new entities to bid to replace as many of the decommissioned OPO regions as they can support. And finally, we highlighted the potential benefits of requiring these new participating entities to provide technology and clinical support services to existing OPOs. Again, our proposal was intended to maximize the benefits to the U.S. transplant ecosystem in general and not just to one entity. If CMS agrees with this direction, Transmedics fully intend to submit bids for donor service areas, or DSAs, associated with decommissioned OPOs later this year or early next. Again, our goal is to drive efficiency, transparency, maximize patient access, and organ utilization for transplants in the U.S. The second growth initiative is NOP Europe. As we've discussed, we are actively building infrastructure and staffing in Italy across four hubs to cover northern and southern Italy. Meanwhile, we're actively engaged and applying for Italian organ transplant air and ground logistics tenders for a few Italian regions as we speak. We are also actively engaged with Benelux region, to establish NOP in the Netherlands and Belgium to create NOP hubs that are staffed by a dedicated clinical transmedic staff to manage OCS cases in these countries. Another important element to our European NOP strategy is to create the first ever dedicated and integrated transplant logistics network to cover the broad European transplant logistics demand. On that front, we announced last week that we've entered into a definitive agreement with a major European charter flight operator, PAD Aviation, or P-A-D Aviation, to partner on creating this European air logistics network. PAD is located in Paderborn, Germany, which is within one to two hour distance from all the major trans-land hubs across Europe. Importantly, they are operating a fleet of same model aircraft that we use in our US fleet, Embraer Phenom 300Es. Simply stated, We're planning to replicate the success of the U.S. NOP in Europe to potentially expand or nearly double our total addressable market, increase OCS clinical adoption, and provide efficient and dedicated transplant logistics service across Europe using our dedicated logistics network. The third growth initiative is the OCS Kidney Program. As we discussed in the last call, this represents our next frontier, with kidney expected to be the first organ to launch on our OCS Gen 3.0 technology platform. Gen 3.0 technology platform will comprise a completely redesigned form factor, hardware, software, and perfusion system that is smaller, lighter, with lower part count, purposefully designed for automated assembly and high reliability. Currently, the development program is running at full speed, and we hope to introduce the final design device and a potentially working device at the American Transplant Congress in Boston in late June. Looking ahead, we are still targeting early 2027 for our US IDE submission for our kidney program. We are extremely excited about this program as it stands to unlock a substantial incremental market opportunity measured in tens of thousands of kidney transplant procedures globally. The fourth growth initiative is OCS technology Gen 3.0, upgrade for both liver, heart, and lung systems. This program is running in parallel to the kidney program to bring significant technology upgrade to our current liver, heart, and lung systems and help catalyze our clinical adoption in these transplant segments. Again, we are intentionally developing our Gen 3 platform to gain supply chain and operating leverage with lower part counts and less reliance on critical third-party suppliers. As you can see, our growth strategy is multifaceted, with catalysts lined up across the short, mid, and long terms. We're excited and laser-focused on investing to ensure the successful execution of these initiatives throughout 2026 and beyond. Now, let me conclude by stating that based on all the dynamics we see today, both in the U.S. transplant ecosystem and at the macro level, we are reiterating our revenue guidance for the full year 2026 between $727 million to $757 million, representing a 20% to 25% growth over full year 2025. We may revisit the guidance later in the year as we gain more visibility on the pace of enhanced and de novo enrollment and other dynamics in the U.S. transplant ecosystem. With that, let me turn the call to Gerardo to cover the detailed financial results for the quarter.

Thank you, Walid. Good afternoon, everybody.