Business
TransMedics Reports Third Quarter 2021 Financial Results
ANDOVER, Mass., Nov. 9, 2021 /PRNewswire/ -- TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ
About this update from Transmedics Group, Inc.
[{"type":"text","content":"ANDOVER, Mass., Nov. 9, 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 September 30, 2021.\n\n \n \n \n \n \n \n\n \nRecent Highlights\nNet revenue of $5.4 million in the third quarter of 2021, a 24% decrease compared to the third quarter of 2020, driven primarily by the expiry of revenue contribution from clinical trials Received FDA 510(k) clearance for OCS Lung cold flush solution on July 29, 2021 Received FDA premarket approval (PMA) for OCS Heart System on September 3, 2021 Received FDA premarket approval (PMA) for OCS Liver System on September 28, 2021 Announced positive top line results from the U.S. randomized OCS DCD Heart trial\"We achieved two critical milestones in the third quarter with the FDA approval of OCS Heart and OCS Liver. With these approvals, we will leverage our unique competitive and regulatory positions to laser focus the organization on commercial growth in 2022 as we embark on a higher growth trajectory for TransMedics,\" said Waleed Hassanein, MD, President and Chief Executive Officer. \"With unrivaled OCS technology, three FDA approved transplant indications with broad labeling, solid operational footing, and our National OCS Program, we are better positioned than ever to deliver on our growth goals and transform organ transplantation.\"\nThird Quarter 2021 Financial Results Net revenue for the third quarter of 2021 was $5.4 million, a 24% decrease compared to $7.1 million in the third quarter of 2020. The decrease was due primarily to the discontinuance of OCS Heart and OCS Liver clinical trial revenue prior to receipt of FDA approvals for both systems in September 2021.\nGross margin for the third quarter of 2021 was 70% as compared to 71% in the third quarter of 2020. \nOperating expenses for the third quarter of 2021 were $15.5 million compared to $9.6 million in the third quarter of 2020. The increase in operating expense was driven by increased investment in the company's National OCS Program, which is a comprehensive organ retrieval and management service, as well as increases in stock compensation expense, and expenses associated with preparing for two FDA advisory committe...