TransMedics Group, Inc.

Good afternoon and welcome to Transmedic's second quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Mr. Brian Johnston from Gilmartin Group for a few introductory comments. Please go ahead.

Thank you, operator. Earlier today, Transmedics released financial results for the quarter ended June 30th, 2021. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meeting of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 with the potential commercial opportunity for our products and our future financial expectations, which include expectations for growth in our organization, regulatory approvals and reimbursement, and guidance and or expectations for revenue, gross margins, and operating expenses in 2021 are based upon our 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 on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2021. 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, August 5th, 2021. With that, I'll now turn the call over to Waleed Hassani, President and Chief Executive Officer.

Thank you, Brian. Good afternoon, everyone, and welcome to Transmedics 2021 Second Quarter Earnings Call. Joining me today is Stephen Gordon, our Chief Financial Officer. As expected, 2021 is shaping up to be a transformative year for Transmedics. Building on our momentum from earlier in the year, we achieved another significant regulatory milestone in the second quarter of this year, with a very strong panel vote in support of the OCS liver indications. Given the panel outcome, we are now looking forward to FDA approvals of both OCF's heart and liver indications in Q3 and early Q4, respectively. In addition to our success with our product pipeline, we also saw continued traction commercially. Net revenue for the second quarter was $8.2 million, representing 141% growth compared to Q2020. It is important to note that this growth was achieved without any liver revenue contribution in 2Q due to completion of the OCS liver cap program. Now let me summarize our progress across our key strategic initiatives. First, the OCS Heart DBD PMA. Following our positive panel vote in April, we're now wrapping up labeling and post-approval program discussions with the review team. Given our current position, we are confident that we are proceeding towards approval of the DBD heart indication within the next several weeks. Second, the OCS liver PMA. In July, we secured a nearly unanimous positive panel vote supporting the approval of the OCS liver for both DBD and DCD indications. We're now actively engaged with FDA review team to finalize the labeling and post-approval program. We are confident that we are proceeding towards approval of the OCS liver indication before year end. Our third initiative is the National OCS program. We're continuing to expand and added one new region in Tampa, Florida, bringing the total to seven initiated regions. We're on track to meet the targeted goal of 10 regions activation before year end. We had several successful cases from several active regions in Q2 that truly underscored the potential transformative nature of this program. One example is we were able to manage, surgically procure, manage and transport pair of donor lungs from the New England region all the way to San Francisco region. This would have never been feasible if it wasn't for the OCS national program. Meanwhile, we're continuing to build the necessary infrastructure and resources to ensure the long-term success of this program. We expect this to continue through early 2022, and as we add new clinical indications after FDA approval of the OCS heart and liver. As we stated before, we believe that the national OCS program will be an important driver for OCS utilization and revenue growth in the U.S., particularly as we continue to expand our comprehensive portfolio of OCS transplant indications. Fourth, we are continuing to advance the OCS heart DCD indication. We completed the enrollment of an additional 90 DCD heart transplants in our CAP program in early Q2. We are on track for the top line results readout to be in Q3 of this year. And we're now coordinating the filing date of the new DCD PMA supplement with the FDA review team. We are optimistic that this will support FDA approval of this DCDR indication in early 2022. Finally, we received FDA clearance of our OCS lung solution for cold preservation of donor lungs. This enables us to provide the most comprehensive product portfolio for lung transplantation in the United States. This gives us a significant competitive advantage to grow our lung business in the US. Now let me finish with a summary of our expectations and thoughts for the remainder of 2021. We're focused on achieving FDA approvals of both OCS heart and liver and are confident that we will be ending 2021 with all three OCS products, all OCS products approved by FDA. This will be a tremendous inflection point on our growth trajectory and will enable Transmedics to make a significant step forward on our mission to transform organ transplant therapy. While receiving this approval is of the utmost importance, our current timelines may limit our near-term ability to leverage CAP programs or continued access programs to drive revenues in Q3. Specifically, we're not initiating any cap programs for liver or heart in Q3, given the imminent FDA decision and approval timing. As such, given the current FDA timelines, we will not issue financial guidance for 2021. Finally, from a macro perspective, I'd also like to comment that while COVID Delta variant is gaining momentum in the US, transplant activities have generally remained unaffected. And currently, are at or slightly above what they were pre-COVID. We're cautiously monitoring the situation and hope that any potential negative impact of the Delta variant will be limited on organ transplantation. With that, I will turn the call to Stephen Gordon, our Chief Financial Officer, to review our detailed financial results for the quarter and the full year.