ANDOVER,
Mass., Oct. 28, 2024 /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, 2024.
Recent Highlights
- Total revenue of $108.8 million
in the third quarter of 2024, a 64% increase compared to the third
quarter of 2023
- Generated net income of $4.2
million or $0.12 per diluted
share in the third quarter of 2024
- Owned 18 total aircraft as of September
30, 2024
"We are proud of our performance year to date and look forward
to ending 2024 on a strong note," said Waleed Hassanein, MD, President and Chief
Executive Officer. "We continued to make meaningful progress across
each of our growth initiatives through the third quarter and
maintain our conviction in our growth runway for 2025 and beyond.
Overall, we remain well on track to reach our stated target of
achieving 10,000 OCS transplant cases per year in the U.S. by
2028."
Third Quarter 2024 Financial Results
Total revenue for the third quarter of 2024 was $108.8 million, a 64% increase compared
to $66.4 million in the third
quarter of 2023. The increase was driven primarily by the increase
in utilization of the Organ Care System ("OCS™") across all three
organs through the National OCS Program ("NOP™") as well as
additional revenue generated by TransMedics logistics services.
Gross margin for the third quarter of 2024 was 56%, compared to
61% in the third quarter of 2023. The change from prior year is a
result of a higher proportion of service revenue compared to
product revenue, which carries a higher margin, in 2024. In
addition, we made investments in our NOP network to prepare for
future growth.
Operating expenses for the third quarter of 2024 were
$56.9 million, compared to
$69.0 million in the third quarter of
2023. The third quarter of 2023 included $27.2 million of non-recurring in-process
research and development. Increases in operating expense were
driven primarily by increased research and development investment
as well as investment throughout the organization to support the
growth of the company. Third quarter operating expenses in 2024
included $7.6 million of stock
compensation expense compared to $5.1
million of stock compensation expense in the third quarter
of 2023.
Net income for the third quarter of 2024 was $4.2 million, or 3.9% of revenue, compared
to a net loss of $25.4 million
in the third quarter of 2023.
Cash was $330.1 million as of
September 30, 2024 compared to
$362.8 million as of June 30, 2024.
2024 Financial Outlook
TransMedics continues to expect
revenue for the full year 2024 to be in the range of $425 million to $445
million, which represents 76% to 84% growth compared to the
company's prior year revenue.
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 October
28, 2024. 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
full-year guidance, our growth initiatives and runway, and
statements about our operations, financial position, and business
plans and our target of achieving 10,000 OCS transplant cases per
year in the U.S. by 2028. For this purpose, all statements other
than statements of historical facts are forward-looking statements.
The words "believe," "may," "will," "estimate," "continue,"
"anticipate," "intend," "expect," "should," "could," "target,"
"predict," "seek" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
subject to a number of risks and uncertainties. Our management
cannot predict all risks, nor can we assess the impact of all
factors 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 and uncertainties, 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 in or implied by the
forward-looking statements. Some of the key factors that could
cause actual results to differ include: our ability to maintain
profitability on a sustained basis; our ability to attract, train
and retain key personnel; 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 until maturity; the fluctuation of our financial results
from quarter to quarter; our need to raise additional funding and
our ability to obtain it on favorable terms, or at all; our ability
to use net operating losses and research and development credit
carryforwards; our dependence on the success of the Organ Care
System or OCS; our ability to expand access to the OCS through our
National OCS Program or NOP; our ability to scale our manufacturing
and sterilization capabilities to meet increasing demand for our
products; the rate and degree of market acceptance of the OCS; our
ability to educate patients, surgeons, transplant centers and
private and public payors on the benefits offered by the OCS; our
ability to improve the OCS platform and develop the next generation
of the OCS products; our dependence on a limited number of
customers for a significant portion of our revenue; our ability to
maintain regulatory approvals or clearances for our OCS products in
the United States, the European
Union, and other select jurisdictions worldwide; our ability to
adequately respond to the Food and Drug Administration or FDA, or
other competent authorities, follow-up inquiries in a timely
manner; the performance of our third-party suppliers and
manufacturers; our use of third parties to transport donor organs
and medical personnel for our NOP and our ability to maintain and
grow our logistics capabilities to support our NOP and reduce
dependence on third party transportation, including by means of
attracting, training and retaining pilots, and the acquisition,
maintenance or replacement of fixed-wing aircraft for our aviation
transportation services or other acquisitions, joint ventures or
strategic investments; our ability to maintain Federal Aviation
Administration or FAA or other regulatory licenses or approvals for
our aircraft transportation services; price increases of the
components of our products and maintenance, parts and fuel for our
aircraft; the timing or results of post-approval studies and any
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
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; the pricing of the OCS, as well
as the reimbursement coverage for the OCS in the United States and internationally;
regulatory developments in the United
States, European Union and other jurisdictions; the extent
and success of competing products or procedures that are or may
become available; our ability to service our 1.50% convertible
senior notes, due 2028; the impact of any product recalls or
improper use of our products; our estimates regarding revenues,
expenses and needs for additional financing; and other factors that
may be described in our filings with the Securities and Exchange
Commission (the "SEC"). Additional information will be made
available in our annual and quarterly reports and other filings
that we make with the SEC. The forward-looking statements in this
press release 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 we are not able 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
Johnston
Laine Morgan
Gilmartin Group
332-895-3222
Investors@transmedics.com
TransMedics Group,
Inc.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(in thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Revenue:
|
|
|
|
|
|
|
|
|
Net product
revenue
|
|
$65,861
|
|
$47,740
|
|
$198,918
|
|
$124,195
|
Service
revenue
|
|
42,900
|
|
18,690
|
|
120,998
|
|
36,254
|
Total
revenue
|
|
108,761
|
|
66,430
|
|
319,916
|
|
160,449
|
Cost of
revenue:
|
|
|
|
|
|
|
|
|
Cost of net product
revenue
|
|
13,246
|
|
11,086
|
|
41,800
|
|
26,950
|
Cost of service
revenue
|
|
34,670
|
|
14,682
|
|
88,048
|
|
27,330
|
Total cost of
revenue
|
|
47,916
|
|
25,768
|
|
129,848
|
|
54,280
|
Gross profit
|
|
60,845
|
|
40,662
|
|
190,068
|
|
106,169
|
|
|
|
|
|
|
|
|
|
Gross margin
|
|
56 %
|
|
61 %
|
|
59 %
|
|
66 %
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research, development
and clinical trials
|
|
14,266
|
|
11,132
|
|
39,504
|
|
25,294
|
Acquired in-process
research and development expenses
|
|
—
|
|
27,212
|
|
—
|
|
27,212
|
Selling, general and
administrative
|
|
42,656
|
|
30,653
|
|
121,712
|
|
84,993
|
Total operating
expenses
|
|
56,922
|
|
68,997
|
|
161,216
|
|
137,499
|
Income (loss) from
operations
|
|
3,923
|
|
(28,335)
|
|
28,852
|
|
(31,330)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(3,617)
|
|
(3,590)
|
|
(10,838)
|
|
(7,186)
|
Interest income and
other income (expense)
|
|
3,939
|
|
4,996
|
|
10,777
|
|
7,982
|
Total other income (expense), net
|
|
322
|
|
1,406
|
|
(61)
|
|
796
|
Income (loss) before
income taxes
|
|
4,245
|
|
(26,929)
|
|
28,791
|
|
(30,534)
|
(Provision) benefit for
income taxes
|
|
(29)
|
|
1,507
|
|
(184)
|
|
1,475
|
Net income
(loss)
|
|
$4,216
|
|
$(25,422)
|
|
$28,607
|
|
$(29,059)
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$0.13
|
|
$(0.78)
|
|
$0.86
|
|
$(0.89)
|
Diluted
|
|
$0.12
|
|
$(0.78)
|
|
$0.81
|
|
$(0.89)
|
Weighted average common
shares outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
33,441,394
|
|
32,614,059
|
|
33,108,253
|
|
32,474,522
|
Diluted
|
|
35,683,952
|
|
32,614,059
|
|
35,218,756
|
|
32,474,522
|
TransMedics Group,
Inc.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
September 30,
2024
|
|
December 31,
2023
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash
|
|
$330,094
|
|
$394,812
|
Accounts
receivable
|
|
90,128
|
|
63,576
|
Inventory
|
|
52,152
|
|
44,235
|
Prepaid expenses and
other current assets
|
|
20,101
|
|
8,031
|
Total current assets
|
|
492,475
|
|
510,654
|
Property, plant and
equipment, net
|
|
271,739
|
|
173,941
|
Operating lease
right-of-use assets
|
|
6,943
|
|
6,546
|
Restricted
cash
|
|
500
|
|
500
|
Goodwill
|
|
11,549
|
|
11,990
|
Acquired intangible
assets, net
|
|
2,202
|
|
2,354
|
Other non-current
assets
|
|
163
|
|
62
|
Total assets
|
|
$785,571
|
|
$706,047
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
|
$13,134
|
|
$12,717
|
Accrued expenses and
other current liabilities
|
|
42,187
|
|
38,221
|
Deferred
revenue
|
|
2,184
|
|
1,961
|
Operating lease
liabilities
|
|
2,543
|
|
2,035
|
Total current
liabilities
|
|
60,048
|
|
54,934
|
Convertible senior
notes, net
|
|
449,237
|
|
447,140
|
Long-term debt,
net
|
|
59,294
|
|
59,064
|
Operating lease
liabilities, net of current portion
|
|
7,072
|
|
7,707
|
Total
liabilities
|
|
575,651
|
|
568,845
|
Total stockholders' equity
|
|
209,920
|
|
137,202
|
Total liabilities and stockholders' equity
|
|
$785,571
|
|
$706,047
|
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SOURCE TransMedics Group, Inc.