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 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 31,
2020, our quarterly reports on Form 10-Q, and in any
subsequent filings with the Securities and Exchange Commission
("SEC"). 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.
TransMedics Group,
Inc.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
Net
revenue
|
|
$
7,053
|
|
$
7,530
|
Cost of
revenue
|
|
2,242
|
|
2,670
|
Gross
profit
|
|
4,811
|
|
4,860
|
Gross
Margin
|
|
68%
|
|
65%
|
Operating
expenses:
|
|
|
|
|
Research, development
and clinical trials
|
|
4,532
|
|
6,225
|
Selling, general and
administrative
|
|
6,786
|
|
6,652
|
Total operating
expenses
|
|
11,318
|
|
12,877
|
Loss from
operations
|
|
(6,507)
|
|
(8,017)
|
Other income
(expense):
|
|
|
|
|
Interest
expense
|
|
(952)
|
|
(1,042)
|
Other income
(expense), net
|
|
(454)
|
|
217
|
Total other expense,
net
|
|
(1,406)
|
|
(825)
|
Loss before income
taxes
|
|
(7,913)
|
|
(8,842)
|
Provision for income
taxes
|
|
(4)
|
|
(10)
|
Net loss
|
|
$
(7,917)
|
|
$
(8,852)
|
Net loss per share
attributable to common stockholders, basic
and
diluted
|
|
$
(0.29)
|
|
$
(0.42)
|
Weighted average
common shares outstanding, basic and diluted
|
|
27,368,090
|
|
21,221,385
|
* Reconciliation of Gross to Net revenue for certain payments
made to customers (in thousands)
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
Gross revenue from
sales to customers
|
|
$
7,637
|
|
$
8,243
|
Less: clinical trial
payments reducing revenue
|
|
584
|
|
713
|
Total net
revenue
|
|
7,053
|
|
7,530
|
TransMedics Group,
Inc.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
26,727
|
|
$
24,581
|
Marketable
securities
|
|
91,386
|
|
101,061
|
Accounts
receivable
|
|
7,395
|
|
6,864
|
Inventory
|
|
11,820
|
|
11,934
|
Prepaid expenses and
other current assets
|
|
3,215
|
|
2,326
|
Total current
assets
|
|
140,543
|
|
146,766
|
Property and
equipment, net
|
|
4,734
|
|
4,754
|
Restricted cash and
other long-term assets
|
|
506
|
|
506
|
Total
assets
|
|
$
145,783
|
|
$
152,026
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,289
|
|
$
1,206
|
Accrued expenses and
other current liabilities
|
|
9,931
|
|
10,317
|
Deferred
revenue
|
|
432
|
|
263
|
Current portion of
deferred rent
|
|
105
|
|
93
|
Total current
liabilities
|
|
11,757
|
|
11,879
|
Long-term debt, net
of discount
|
|
34,787
|
|
34,657
|
Deferred rent, net of
current portion
|
|
1,564
|
|
1,599
|
Total
liabilities
|
|
48,108
|
|
48,135
|
Total stockholders'
equity
|
|
97,675
|
|
103,891
|
Total liabilities and
stockholders' equity
|
|
$
145,783
|
|
$
152,026
|
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SOURCE TransMedics Group, Inc.