GlobeNewswire Inc | Aug 5, 2020 04:01PM EDT

August 05, 2020

ANDOVER, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- 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 June 30, 2020.

Recent Highlights

-- OCS Heart FDA Advisory Committee meeting rescheduled as a virtual meeting to be held on October 7, 2020 -- Submitted OCS Liver PMA to FDA in June 2020 -- OCS Heart DCD U.S. clinical program surpassed 50 transplants; enrollment completion expected in Q4 2020 -- Completed underwritten public equity offering raising $75 million in net proceeds

Despite the continued impact of the COVID-19 pandemic on our revenue, we achieved several significant milestones in the second quarter. We are leaning forward to advance our commercial, clinical, and regulatory initiatives to position TransMedics to achieve our long-term strategic growth objectives, said Waleed Hassanein, MD, President and Chief Executive Officer. We are laser focused on ensuring that we are in a position to have our three OCS products OCS Lung, OCS Heart, and OCS Liver approved and commercially available in the U.S. in 2021.

Second Quarter 2020 Financial Results Net revenue for the second quarter of 2020 was $3.4 million, a 40% decrease compared to $5.7 million in the second quarter of 2019. The decrease in revenue was a result of fewer organ transplant procedures performed during the period due to the impact of the global COVID-19 pandemic.

Gross margin for the second quarter of 2020 was 56% as compared to 59% in the second quarter of 2019.

Operating expenses for the second quarter of 2020 were $9.8 million compared to $11.0 million in the second quarter of 2019. The decrease in operating expenses was due primarily to our cash conservation steps and decreased activities as a result of the global COVID-19 pandemic.

Net loss for the second quarter of 2020 was $8.5 million compared to $9.2 million in the second quarter of 2019.

Cash, cash equivalents and marketable securities were $139.4 million as of June 30, 2020.

2020 Financial OutlookAs previously announced, TransMedics is not providing annual guidance for 2020 due to the unpredictability of the duration and the magnitude of the impact of theCOVID-19pandemic.

Webcast and Conference Call DetailsThe TransMedics management team will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT on Wednesday, August 5, 2020. Investors interested in listening to the conference call may do so by dialing (866) 221-1172 for domestic callers or (270) 215-9603 for international callers, followed by Conference ID: 9858896. 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 worlds 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 StatementsThis 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 operations; our ability to attract and retain key personnel; our ability to protect, defend, maintain and enforce our intellectual property rights relating to the OCS and avoid allegations that our products infringe, misappropriate or otherwise violate the intellectual property rights of third parties; our ability to obtain and maintain regulatory approvals or clearance for our OCS products; the pricing of the OCS, as well as the reimbursement coverage for the OCS in the United States and internationally; and the risks identified under the heading Risk Factors and elsewhere in our annual report on Form 10-K for the year ended December 28, 2019 and our quarterly report on Form 10-Q for the quarter ended March 31, 2020, which is available on the SECs website at www.sec.gov. Additional information will be made available by our annual and quarterly reports and other filings that we make from time to time with the SEC. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

Investor Contact:Brian Johnston631-807-1986Investors@transmedics.com

TransMedics Group, Inc.CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands)

Fiscal Three Months Ended Fiscal Six Months Ended June 30, 2020 June 29, 2019 June 30, 2020 June 29, 2019Net revenue $ 3,391 $ 5,666 $ 10,921 $ 10,342 Cost of 1,482 2,333 4,152 4,436 revenueGross profit 1,909 3,333 6,769 5,906 Gross Margin 56 % 59 % 62 % 57 %Operating expenses:Research,development 3,903 4,787 10,128 8,669 and clinicaltrialsSelling,general and 5,867 6,251 12,519 10,904 administrativeTotaloperating 9,770 11,038 22,647 19,573 expensesLoss from (7,861 ) (7,705 ) (15,878 ) (13,667 )operationsOther income (expense):Interest (1,001 ) (1,113 ) (2,043 ) (2,206 )expenseChange in fairvalue ofpreferred ? (614 ) ? (341 )stock warrantliabilityOther income 371 247 588 144 (expense), netTotal other (630 ) (1,480 ) (1,455 ) (2,403 )expense, netLoss before (8,491 ) (9,185 ) (17,333 ) (16,070 )income taxesProvision for (6 ) (10 ) (16 ) (20 )income taxesNet loss $ (8,497 ) $ (9,195 ) $ (17,349 ) $ (16,090 )Net loss pershareattributableto common $ (0.36 ) $ (0.70 ) $ (0.78 ) $ (2.21 )stockholders,basic and dilutedWeightedaverage commonshares 23,330,918 13,133,834 22,259,047 7,277,237 outstanding,basic anddiluted

* Reconciliation of Gross to Net revenue for certain payments made to customers (in thousands)

Fiscal Three Months Fiscal Six Months Ended Ended June 30, June 29, June 30, June 29, 2020 2019 2020 2019Gross revenuefrom sales to $ 3,923 $ 6,215 $ 12,166 $ 11,505 customersLess: clinicaltrial payments 532 549 1,245 1,163 reducing revenueTotal net revenue $ 3,391 $ 5,666 $ 10,921 $ 10,342

TransMedics Group, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited)

June 30, December 28, 2020 2019Current assets: Cash and cash equivalents $ 51,152 $ 20,092Marketable securities 88,223 60,596Accounts receivable 4,431 6,559Inventory 12,555 11,216Prepaid expenses and other current assets 1,866 1,538Total current assets 158,227 100,001Property and equipment, net 4,404 4,792Restricted cash and other long-term assets 506 506Total assets $ 163,137 $ 105,299Current liabilities: Accounts payable $ 3,722 $ 7,247Accrued expenses and other current 8,858 8,332liabilitiesDeferred revenue 1,020 166Current portion of deferred rent 218 370Total current liabilities 13,818 16,115Long-term debt, net of discount 34,395 34,146Deferred rent, net of current portion 1,164 389Total liabilities 49,377 50,650Total stockholders' equity 113,760 54,649Total liabilities and stockholders' equity $ 163,137 $ 105,299