ANDOVER, Mass., Aug. 5, 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 June
30, 2021.
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 Waleed Hassanein, MD, President and Chief
Executive Officer. "We remain confident in our long-term outlook
and in our unique ability to transform organ transplantation
globally."
Second Quarter 2021 Financial Results
Net revenue for the second quarter of 2021 was $8.2 million, a 141% increase compared to
$3.4 million in the second quarter of
2020. The increase was predominantly a result of stronger sales of
OCS Lung and Heart disposable sets in the
United States and internationally as transplants recovered
from the COVID-19 impacted second quarter of 2020.
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
$15.5 million compared to
$9.8 million in the second quarter of
2020. The increase in operating expense was driven by increased
investment in our National OCS Program, stock compensation expense,
and expenses associated with preparing for two FDA advisory
committee panels.
Net loss for the second quarter of 2021 was $10.7 million compared to $8.5 million in the second quarter of 2020.
Cash, cash equivalents and marketable securities were
$112.2 million as of June 30, 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 Thursday, August 5, 2021.
Investors interested in listening to the conference call may do so
by dialing (833) 378-1026 for domestic callers or (236) 712-2500
for international callers, followed by Conference ID: 9861546. 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 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
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
|
TransMedics Group,
Inc.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
June 30,
2021
|
|
December 31,
2020
|
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 TransMedics Group, Inc.