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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 27, 2025

 

 

TransMedics Group, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Massachusetts

001-38891

83-2181531

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

200 Minuteman Road

 

Andover, Massachusetts

 

01810

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (978) 552-0900

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, no par value per share

 

TMDX

 

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 2.02 Results of Operations and Financial Condition.

On February 27, 2025, TransMedics Group, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter and year ended December 31, 2024. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.

 

Description

99.1

Press release issued by TransMedics Group, Inc. on February 27, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

TRANSMEDICS GROUP, INC.

 

 

 

 

Date:

February 27, 2025

By:

/s/ Gerardo Hernandez

 

 

 

Name: Gerardo Hernandez
Title: Chief Financial Officer and Treasurer

 


Exhibit 99.1

TransMedics Reports Fourth Quarter and Full Year 2024 Financial Results

Andover, Mass. – February 27, 2025 – 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 and year ended December 31, 2024.

Recent Highlights

Total revenue of $121.6 million in the fourth quarter of 2024, a 50% increase compared to the fourth quarter of 2023
Total revenue of $441.5 million in the full year of 2024, an 83% increase compared to the full year 2023
Generated net income of $6.9 million, or $0.19 per diluted share, in the fourth quarter of 2024
Generated net income of $35.5 million, or $1.01 per diluted share, in the full year 2024
Completed 3,715 U.S. OCS cases in the full year 2024, a 58% increase compared to 2,347 U.S. OCS cases in the full year 2023
Achieved overall OCS market share of 20.9% across all 3 organs for the full year 2024, up from 13.8% in 2023
Owned 19 aircraft as of December 31, 2024, and purchased two additional aircraft in 2025 to-date
Concluded independent review of business practices following allegations raised in a recent short report. Kirkland & Ellis LLP, supported by an expert outside forensic accounting firm, identified no evidence of misconduct.
Submitted comprehensive response, in coordination with experts at Covington & Burline LLP, to FDA following recent Citizen Petition

“We are proud of our 2024 results as we delivered 83% year over year revenue growth while achieving profitability, investing in our pipeline, and continuing to build our infrastructure to capitalize on our highly differentiated technology and service offering,” said Waleed Hassanein, MD, President and Chief Executive Officer. “We stand firmly by our business and our dedicated, world-class NOP surgical and clinical leadership and team. We are humbled by and proud of the significant life-saving impact of our OCS technology and NOP teams, and we remain committed to our mission of expanding access and improving clinical outcomes to patients in need of organ transplants.”

Fourth Quarter 2024 Financial Results

Total revenue for the fourth quarter of 2024 was $121.6 million, a 50% increase compared to $81.2 million in the fourth quarter of 2023. The increase was driven primarily by an increase in utilization of the Organ Care System (“OCSTM”) across all three organs through our National OCS Program (“NOPTM”) as well as additional revenue generated by TransMedics logistics services.

 


 

Gross margin for the fourth quarter of 2024 was 59.2%, showing a slight improvement from 59.0% in Q4 of 2023.

Operating expenses for the fourth quarter of 2024 were $63.4 million, compared to $45.3 million in the fourth quarter of 2023. The increase in operating expense was driven primarily by increased research and development investment as well as investment throughout the organization to support the growth of the company. Fourth quarter operating expenses in 2024 included $10.4 million of stock compensation expense, compared to $5.5 million of stock compensation expense in the fourth quarter of 2023.

Net income for the fourth quarter of 2024 was $6.9 million, or 6% of revenue, compared to $4.0 million in the fourth quarter of 2023.

Full Year 2024 Financial Results

Total revenue for the full year of 2024 was $441.5 million, an 83% increase compared to $241.6 million for the full year of 2023. The increase was driven primarily by the increase in utilization of the OCS across all three organs through the NOP as well as additional revenue generated by TransMedics logistics services.

Gross margin for the full year of 2024 was 59.4%, compared to 63.8% in the full year of 2023. The change from prior year was a result of a higher proportion of service revenue compared to product revenue, which carries a higher margin, in 2024. The company also made investments in its NOP network to prepare for future growth.

Operating expenses for the full year of 2024 were $224.6 million, compared to $182.8 million in the full year of 2023. The increase in operating expense was driven primarily by increased research and development investment as well as investment throughout the organization to support the growth of the company. Full year operating expenses in 2024 included $31.7 million of stock compensation expense compared to $19.4 million of stock compensation expense in the full year of 2023.

Net income for the full year of 2024 was $35.5 million, or 8% of revenue, compared to a net loss of $25.0 million in the full year of 2023.

Cash was $336.7 million as of December 31, 2024 compared to $330.1 million as of September 30, 2024.

2025 Financial Outlook

TransMedics expects total revenue for the full year 2025 to be in the range of $530 million to $552 million, which represents 20% to 25% 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 Thursday, February 27, 2025. Investors interested in listening to the conference call may do so by dialing (844) 481-2832 for domestic callers or (412) 317-1852 for international callers and ask to be joined into the TransMedics call. A live and archived webcast of the event will be available on the "Investors" section of the TransMedics website at https://investors.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, and statements about our operations, financial position, and business plans. 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: the fluctuation of our financial results from quarter to quarter; 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; we may not be able to sustain profitability; 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; that we have identified a material weakness in our internal control over financial reporting, and that we may identify additional material weaknesses in the future; 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 improve the OCS platform, including by developing the next generation of the OCS products or expanding into new indications; 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 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 to 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 or services 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 December 31,

Year Ended December 31,

2024

2023

2024

2023

Revenue:

Net product revenue

$

74,948

$

51,874

$

273,866

$

176,069

Service revenue

46,676

29,300

167,674

65,554

Total revenue

121,624

81,174

441,540

241,623

Cost of revenue:

Cost of net product revenue

16,545

14,065

58,345

41,015

Cost of service revenue

33,066

19,185

121,114

46,515

Total cost of revenue

49,611

33,250

179,459

87,530

Gross profit

72,013

47,924

262,081

154,093

Gross margin

59

%

59

%

59

%

64

%

Operating expenses:

Research, development and clinical trials

16,464

10,761

55,968

36,055

Acquired in-process research and development expenses

27,212

Selling, general and administrative

46,905

34,560

168,617

119,553

Total operating expenses

63,369

45,321

224,585

182,820

Income (loss) from operations

8,644

2,603

37,496

(28,727

)

Other income (expense):

Interest expense

(3,571

)

(3,605

)

(14,409

)

(10,791

)

Interest income and other income (expense), net

1,916

4,865

12,693

12,847

          Total other income (expense), net

(1,655

)

1,260

(1,716

)

2,056

Income (loss) before income taxes

6,989

3,863

35,780

(26,671

)

(Provision) benefit for income taxes

(132

)

168

(316

)

1,643

Net income (loss)

$

6,857

$

4,031

$

35,464

$

(25,028

)

Net income (loss) per share:

Basic

$

0.20

$

0.12

$

1.07

$

(0.77

)

Diluted

$

0.19

$

0.12

$

1.01

$

(0.77

)

Weighted average common shares outstanding:

Basic

33,592,408

32,644,525

33,229,953

32,517,372

Diluted

35,211,121

34,179,059

35,216,837

32,517,372

 

 

 

 

 

 

 


 

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

December 31,

2024

2023

Assets

Current assets:

Cash

$

336,650

$

394,812

Accounts receivable

97,722

63,576

Inventory

46,554

44,235

Prepaid expenses and other current assets

16,290

8,031

           Total current assets

497,216

510,654

Property, plant and equipment, net

285,970

173,941

Operating lease right-of-use assets

6,481

6,546

Restricted cash

500

500

Goodwill

11,549

11,990

Acquired intangible assets, net

2,152

2,354

Other non-current assets

208

62

           Total assets

$

804,076

$

706,047

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

10,292

$

12,717

Accrued expenses and other current liabilities

45,152

38,221

Deferred revenue

1,742

1,961

Operating lease liabilities

2,727

2,035

Total current liabilities

59,913

54,934

Convertible senior notes, net

449,939

447,140

Long-term debt, net

59,372

59,064

Operating lease liabilities, net of current portion

6,249

7,707

    Total liabilities

575,473

568,845

    Total stockholders’ equity

228,603

137,202

    Total liabilities and stockholders’ equity

$

804,076

$

706,047

 

 


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Feb. 27, 2025
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Document Period End Date Feb. 27, 2025
Entity Registrant Name TransMedics Group, Inc.
Entity Central Index Key 0001756262
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Entity Incorporation, State or Country Code MA
Entity Tax Identification Number 83-2181531
Entity Address, Address Line One 200 Minuteman Road
Entity Address, City or Town Andover
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Title of 12(b) Security Common Stock, no par value per share
Trading Symbol TMDX
Security Exchange Name NASDAQ

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