TransMedics reports strong Q3 2026 results

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, TransMedics Group, Inc. (the "Company") issued a press release announcing the Company's financial results for the quarter ended September 30, 2026.^{1 1}A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.¹

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.²

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1

Press release issued by TransMedics Group, Inc. on November 5, 2026

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:

November 5, 2026

By:

/s/ Fernando Araujo

Name: Fernando Araujo

Title: Chief Financial Officer and Treasurer

PRESS RELEASE

TransMedics Reports Third Quarter 2026 Financial Results

Strong Revenue Generation Drives Increase in Full-Year 2026 Guidance; Recent Progress Positions Company for Continued Growth with Several Near- and Mid-Term Catalysts

Andover, Mass. – November 5, 2026 – 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, 2026.

Third Quarter 2026 Financial Highlights

Recent Business Highlights

• Completed enrollment in Part A of the Next-Generation Organ Care System (OCS) ENHANCE Heart trial (September) and received U.S. Food and Drug Administration (FDA) approval of a continued access protocol, allowing enrollment of an additional 90 patients (October)

• Received Investigational Device Exemption (IDE) approvals from U.S. FDA for ENHANCE Heart Part B and DENOVO Lung trials⁷, including use of TransMedics Controlled Hypothermic Organ Preservation System (CHOPS) as a control arm for both trials (October)

• Awarded first European transplant logistics tender in Italy, commencing the company's European transplant operations using PAD Aviation (October)

• Appointed Fernando Araujo, former CFO of GE HealthCare's Advanced Imaging Solutions segment, as Chief Financial Officer (September)

"The third quarter of 2026 was the strongest in TransMedics' history, with record revenue and record case volume. Importantly, we delivered these results despite typical third quarter seasonality and before any contribution from ENHANCE Part B or DENOVO." said Waleed Hassanein, MD, President and Chief Executive Officer. "We enter 2027 with strong momentum and a robust set of growth catalysts. ENHANCE Heart Part B and DENOVO Lung target large, untapped heart and lung segments, with two shots on goal in each through OCS and CHOPS. In Europe, we plan to launch OCS NOP in Italy, the Netherlands and Belgium, building on our first European transplant logistics win. And OCS Kidney remains on track for first-in-human clinical experience in the second half of 2027, our path into the largest transplant market. Our strategy is clear. Our execution is proven. Our conviction has never been stronger. We are building the global platform to transform organ transplantation, and we strongly believe our best years are still ahead."

Recent IDE Approvals

In October, TransMedics received full U.S. Food and Drug Administration (FDA) IDE approvals for Part B of the OCS ENHANCE Heart trial and DENOVO Lung trial as the company further advances its OCS platform into new indications, seeks to capture new commercial opportunity, and addresses patient needs.

EU Expansion

TransMedics continues to expand its operations in the EU, including through winning its first logistics tender in Italy. This milestone supports the company's growth strategy into key European markets and follows the establishment of its dedicated organ transplantation air logistics network through the recent strategic investment in PAD Aviation.

Third Quarter 2026 Financial Results

A summary of third quarter financial results is as follows (dollars in thousands except per share):

Three Months Ended September 30,

Nine Months Ended September 30,

2026

2025

% Change

2026

2025

% Change

Revenue

$203,005

$143,823

41%

$566,886

$444,730

27%

Income from operations

$28,141

$23,300

21%

$65,174

$87,310

-25%

Operating margin %

13.9%

16.2%

-230bps

11.5%

19.6%

-810bps

Adjusted income from operations (1)

$28,872

$23,571

22%

$72,772

$89,939

-19%

Adjusted operating margin % (1)

14.2%

16.4%

-220bps

12.8%

20.2%

-740bps

Diluted net income per share

$0.46

$0.66

-30%

$1.08

$2.28

-53%

Adjusted diluted net income per share (1)

$0.51

$0.67

-24%

$1.26

$2.33

-46%

(1) Adjusted income from operations, adjusted operating margin and adjusted diluted net income per share represent non-GAAP financial measures. For a reconciliation of GAAP to non-GAAP items, please see the tables attached to this press release.

Total revenue for the third quarter of 2026 was $203.0 million, a 41% increase compared to $143.8 million in the third quarter of 2025.³ The increase was due primarily to increasing Liver and Heart volume through the National OCS Program ("NOP") as well as additional revenue generated by TransMedics logistics services, and the contribution of PAD Aviation following the Company's strategic investment on July 1, 2026.

Gross margin was 58.5%, compared with 58.8% in the prior-year period. The year-over-year decrease primarily reflected a higher mix of service revenue, partly offset by reduced scrap, lower inventory adjustments and logistics efficiencies resulting from pricing improvements across both service and logistics operations, productivity gains from reduced supplement