News Release
TransMedics Reports Second Quarter 2021 Financial Results
Recent Highlights
- Net revenue of
$8.2 million in the second quarter of 2021, representing a 141% increase compared to the second quarter of 2020 - Announced positive FDA advisory committee vote for OCS Liver System
- Received FDA 510(k) clearance of the OCS Lung Solution for use in lung transplants using cold storage techniques
- OCS Liver PROTECT Trial results presented and recognized as the winner of The People's Choice Award for Most Impactful Presentation at the
American Transplant Congress
"Over the last several months we achieved significant milestones towards having our three OCS products FDA-approved and commercially available in the US before year end," said
Second Quarter 2021 Financial Results
Net revenue for the second quarter of 2021 was
Gross margin for the second quarter of 2021 was 68% as compared to 56% in the second quarter of 2020.
Operating expenses for the second quarter of 2021 were
Net loss for the second quarter of 2021 was
Cash, cash equivalents and marketable securities were
Webcast and Conference Call Details
The
About
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 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
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CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(in thousands, except share and per share data) |
||||||||
(unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
Net revenue |
$ 8,171 |
$ 3,391 |
$ 15,224 |
$ 10,921 |
||||
Cost of revenue |
2,582 |
1,482 |
4,824 |
4,152 |
||||
Gross profit |
5,589 |
1,909 |
10,400 |
6,769 |
||||
Gross Margin |
68% |
56% |
68% |
62% |
||||
Operating expenses: |
||||||||
Research, development and clinical trials |
6,295 |
3,903 |
10,827 |
10,128 |
||||
Selling, general and administrative |
9,162 |
5,867 |
15,948 |
12,519 |
||||
Total operating expenses |
15,457 |
9,770 |
26,775 |
22,647 |
||||
Loss from operations |
(9,868) |
(7,861) |
(16,375) |
(15,878) |
||||
Other income (expense): |
||||||||
Interest expense |
(965) |
(1,001) |
(1,917) |
(2,043) |
||||
Other income (expense), net |
171 |
371 |
(283) |
588 |
||||
Total other expense, net |
(794) |
(630) |
(2,200) |
(1,455) |
||||
Loss before income taxes |
(10,662) |
(8,491) |
(18,575) |
(17,333) |
||||
Provision for income taxes |
(6) |
(6) |
(10) |
(16) |
||||
Net loss |
$ (10,668) |
$ (8,497) |
$ (18,585) |
$ (17,349) |
||||
Net loss per share attributable to common stockholders, basic and diluted |
$ (0.39) |
$ (0.36) |
$ (0.68) |
$ (0.78) |
||||
Weighted average common shares outstanding, basic and diluted |
27,620,764 |
23,330,918 |
27,495,125 |
22,259,047 |
||||
* Reconciliation of Gross to Net revenue for certain payments made to customers (in thousands) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
Gross revenue from sales to customers |
$ 8,667 |
$ 3,923 |
$ 16,304 |
$ 12,166 |
||||
Less: clinical trial payments reducing revenue |
496 |
532 |
1,080 |
1,245 |
||||
Total net revenue |
$ 8,171 |
$ 3,391 |
$ 15,224 |
$ 10,921 |
|
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CONDENSED CONSOLIDATED BALANCE SHEETS |
||||
(in thousands) |
||||
(unaudited) |
||||
|
|
|||
Current assets: |
||||
Cash and cash equivalents |
$ 25,314 |
$ 24,581 |
||
Marketable securities |
86,935 |
101,061 |
||
Accounts receivable |
6,271 |
6,864 |
||
Inventory |
13,007 |
11,934 |
||
Prepaid expenses and other current assets |
3,525 |
2,326 |
||
Total current assets |
135,052 |
146,766 |
||
Property and equipment, net |
4,954 |
4,754 |
||
Restricted cash and other long-term assets |
506 |
506 |
||
Total assets |
$ 140,512 |
$ 152,026 |
||
Current liabilities: |
||||
Accounts payable |
$ 2,389 |
$ 1,206 |
||
Accrued expenses and other current liabilities |
12,100 |
10,317 |
||
Deferred revenue |
473 |
263 |
||
Current portion of deferred rent |
117 |
93 |
||
Total current liabilities |
15,079 |
11,879 |
||
Long-term debt, net of discount |
34,921 |
34,657 |
||
Deferred rent, net of current portion |
1,529 |
1,599 |
||
Total liabilities |
51,529 |
48,135 |
||
Total stockholders' equity |
88,983 |
103,891 |
||
Total liabilities and stockholders' equity |
$ 140,512 |
$ 152,026 |
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SOURCE
Investor Contact: Brian Johnston, 631-807-1986, Investors@transmedics.com