Earnings release
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m TransMedics . Bringing new life to organ transplant TransMedics Reports First Quarter 2021 Financial Results May 4 , 2021 ANDOVER , Mass . , May 4 , 2021 / PRNewswire / -- TransMedics Group , Inc. ( " TransMedics " ) ( Nasdaq : TMDX ) , a medical technology company that is transforming organ transplant therapy for patients with end - stage lung , heart , and liver failure , today reported financial results for the quarter ended March 31 , 2021 . Recent Highlights • Net revenue of $ 7.1 million in the first quarter of 2021 , representing a 6 % decrease compared to the first quarter of 2020 Reported U.S. net revenue growth of 11 % year - over - year ● • Announced positive FDA advisory committee vote for OCS Heart System • Appointed Stephanie Lovell to Board of Directors • Announced expectation for mid - July 2021 OCS Liver FDA advisory committee meeting " We are pleased with our progress as we advance quickly toward several near term regulatory and commercial catalysts expected in 2021 , " said Waleed Hassanein , MD , President and Chief Executive Officer . " Following the favorable FDA advisory panel vote for OCS Heart , we are working with FDA to map out the process to a decision on our PMA . In addition , we are making significant progress towards our key 2021 catalysts and strategic initiatives , which gives us confidence in our long - term outlook . " First Quarter 2021 Financial Results Net revenue for the first quarter of 2021 was $ 7.1 million , a 6 % decrease compared to $ 7.5 million in the first quarter of 2020. US net revenue was $ 5.8 million in the first quarter of 2021 , an 11 % increase from $ 5.2 million in the first quarter of 2020. The increase in US net revenue driven by strong OCS Lung and OCS Heart sales , was offset by the completion of the OCS Liver PROTECT CAP and lower transplant activity outside of the US . Gross margin for the first quarter of 2021 was 68 % as compared to 65 % in the first quarter of 2020 . Operating expenses for the first quarter of 2021 were $ 11.3 million compared to $ 12.9 million in the first quarter of 2020. The decrease in operating expense was driven by limited travel and other spending due to COVID , which more than offset the increased investment in the National OCS Program . Net loss for the first quarter of 2021 was $ 7.9 million compared to $ 8.9 million in the first quarter of 2020 . Cash , cash equivalents and marketable securities were $ 118.1 million as of March 31 , 2021 . Webcast and Conference Call Details The TransMedics management team will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT on Tuesday , May 4 , 2021. Investors interested in listening to the conference call may do so by dialing ( 866 ) 393-4306 for domestic callers or ( 763 ) 488-9145 for international callers , followed by Conference ID : 1172894. A live and archived webcast of the event will be available on the " Investors " section of the TransMedics website at www.transmedics.com . About TransMedics Group , Inc. TransMedics is the world's leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation . Headquartered in Andover , Massachusetts , the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality , assess organ viability prior to transplant , and potentially increase the utilization of donor organs for the treatment of end - stage heart , lung and liver failure . Forward - Looking Statements This press release contains forward - looking statements with respect to , among other things , our operations and financial performance and expected timing of regulatory approvals for our OCS products . These forward - looking statements are subject to a number of risks , uncertainties and assumptions . Moreover , we operate in a very competitive and rapidly changing environment and new risks emerge from time to time . It is not possible for our management to predict all risks , nor can we assess the impact of all factors on our business or the extent to which any factor , or combination of factors , may cause actual results to differ materially from those contained in or implied by any forward - looking statements we may make . In light of these risks , uncertainties and assumptions , the forward - looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward - looking statements . Some of the key factors that could cause actual results to differ include : that we continue to incur losses ; our need to raise additional funding ; our existing and any future indebtedness , including our ability to comply with affirmative and negative covenants under our credit agreement to which we will remain subject to until maturity , and our ability to obtain additional financing on favorable terms or at all ; the fluctuation of our financial results from quarter to quarter ; our ability to use net operating losses and research and development credit carryforwards ; our dependence on the success of the OCS ; the rate and degree of market acceptance of the OCS ; our ability to educate patients , surgeons , transplant centers and private payors of benefits offered by the OCS ; the impact of the outbreak of the novel strain of coronavirus and associated containment and remediation efforts ; our ability to improve the OCS platform ; our dependence on a limited number of customers for a significant portion of our net revenue ; the timing of and our ability to obtain and maintain regulatory approvals or clearances for our OCS products ; our ability to adequately respond to FDA follow - up inquiries in a timely manner ; the performance of our third - party suppliers and manufacturers ; the timing or results of clinical trials for the OCS ; our manufacturing , sales , marketing and clinical support capabilities and strategy ; attacks against our information technology infrastructure ; the economic , political and other risks associated with our foreign