TMDX on Nasdaq

TransMedics Group, Inc.

In its 2026 annual report the company says: “We are a medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS.”4 It is headquartered in Andover, Massachusetts.1 Its shares trade on Nasdaq under the symbol TMDX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTMDX on Nasdaq1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersAndover, Massachusetts1
  • Incorporated inMA2
  • Business address200 Minuteman Road, Andover, Ma 018102
  • Filer categoryLarge accelerated filer2

We are a medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the OCS to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the …4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

59.9%Gross margin5
17.9%Operating margin5
31.4%Net margin5
37.1%Revenue growth, 20255
40.2%Return on equity5
$133.6MFree cash flow5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 61% of the revenue TransMedics Group, Inc. broke down this way in fiscal 2025.

  1. Product$372.4M561%up 36% from 2024
  2. Service$233.1M538%up 39% from 2024
  3. Service Unrelated to OCS Transplant$4.1M51%down 7% from 2024
Products and services by year
Products and services202320242025
Product$176.0M$273.7M$372.4M
Service$65.6M$167.7M$233.1M
Service Unrelated to OCS Transplant$4.9M$4.4M$4.1M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue32¢$242.7M
  • Research and development9¢$69.1M
  • Selling, general and admin24¢$185.2M
  • Income tax11¢$82.8M
  • Profit25¢$190.3M

Out of $605.5M in revenue.5

Where each dollar of operating cash went, fiscal 2025

  • Capital spending31¢$59.3M
  • Kept or used elsewhere69¢$133.6M

Out of $192.8M of cash from operations.5

Financial statements

Revenue6785$605.5M in 2025+2243% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $25.8M$25.8M20192020: $28.4M$28.4M2020+10%2021: $31.4M$31.4M2021+11%2022: $93.5M$93.5M2022+198%2023: $241.6M$241.6M2023+159%2024: $441.5M$441.5M2024+83%2025: $605.5M$605.5M2025+37%
Gross profit691085$362.8M in 2025+2517% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $13.9M$13.9M20192020: $16.6M$16.6M2020+20%2021: $21.2M$21.2M2021+27%2022: $65.3M$65.3M2022+208%2023: $154.1M$154.1M2023+136%2024: $262.1M$262.1M2024+70%2025: $362.8M$362.8M2025+38%
Operating income691085$108.6M in 2025
-$50.0M0$50.0M$100.0M$150.0M2019: -$29.6M-$29.6M20192020: -$26.4M-$26.4M2020−11%2021: -$39.4M-$39.4M2021+49%2022: -$31.4M-$31.4M2022−20%2023: -$28.7M-$28.7M2023−9%2024: $37.5M$37.5M20242025: $108.6M$108.6M2025+190%
Net income691085$190.3M in 2025
-$100.0M0$100.0M$200.0M2019: -$33.5M-$33.5M20192020: -$28.7M-$28.7M2020−14%2021: -$44.2M-$44.2M2021+54%2022: -$36.2M-$36.2M2022−18%2023: -$25.0M-$25.0M2023−31%2024: $35.5M$35.5M20242025: $190.3M$190.3M2025+437%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenue$605.5M$441.5M$241.6M
Total cost of revenue$242.7M$179.5M$87.5M
Gross profit$362.8M$262.1M$154.1M
Research, development and clinical trials$69.1M$56.0M$36.1M
Acquired in-process research and development expenses$27.2M
Selling, general and administrative$185.2M$168.6M$119.6M
Total operating expenses$254.2M$224.6M$182.8M
Income (loss) from operations$108.6M$37.5M-$28.7M
Interest expense-$13.8M-$14.4M-$10.8M
Interest income and other income (expense), net$12.7M$12.7M$12.8M
Total other income (expense), net-$1.1M-$1.7M$2.1M
Income (loss) before income taxes$107.5M$35.8M-$26.7M
(Provision) benefit for income taxes$82.8M-$316.0K$1.6M
Net income (loss)$190.3M$35.5M-$25.0M
Net income (loss) per share, basic$5.60$1.07-$0.77
Net income (loss) per share, diluted$4.87$1.01-$0.77
Weighted average common shares outstanding, basic34.0M shares33.2M shares32.5M shares
Weighted average common shares outstanding, diluted40.5M shares35.2M shares32.5M shares

Compare TransMedics Group, Inc. with another company

Corporate structure

TransMedics Group, Inc. sits at the top of its group. 6 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TransMedics Group, Inc.

  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on TransMedics Group, Inc., latest Apr 30, 2026
  • VANGUARD PORTFOLIO MANAGEMENT LLC Filed SCHEDULE 13G on TransMedics Group, Inc., latest Apr 29, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on TransMedics Group, Inc., latest Mar 27, 2026 (4 filings since Feb 9, 2023)
  • BlackRock Filed SCHEDULE 13G/A on TransMedics Group, Inc., latest Jul 18, 2025 (5 filings since Feb 3, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on TransMedics Group, Inc., latest May 12, 2025 (6 filings since Feb 9, 2022)
  • Macquarie Group Filed SC 13G/A on TransMedics Group, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
  • Sandhill Capital Partners LLC Filed SC 13G/A on TransMedics Group, Inc., latest Feb 10, 2023 (2 filings since Feb 11, 2022)
  • Credit Suisse Filed SC 13G/A on TransMedics Group, Inc., latest Feb 2, 2023 (2 filings since Feb 14, 2022)
  • TransMedics Group, Inc. Andover, Massachusetts
    • Northside Property Group, LLC Subsidiary · Montana, United States
    • Summit Aviation, Inc. Subsidiary · Montana, United States
    • TMDX Realty Holdings LLC Subsidiary · Delaware, United States
    • TransMedics GmbH Subsidiary · Germany
    • TransMedics S.r.l. Subsidiary · Italy

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TransMedics Group, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$393.7M5 Dec 31, 2025$326.7M5 Dec 31, 2024+20.5%
Accumulated depreciation$66.1M5 Dec 31, 2025$40.7M5 Dec 31, 2024+62.3%
Property and equipment, net$327.7M5 Dec 31, 2025$286.0M5 Dec 31, 2024+14.6%
Operating-lease assets (leased space)$5.2M5 Dec 31, 2025$6.5M5 Dec 31, 2024−20.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$11.5M5 Dec 31, 2025$11.5M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$1.9M5 Dec 31, 2025$2.2M5 Dec 31, 2024−9.5%
Finite-lived intangibles, gross$2.4M5 Dec 31, 2025$2.4M5 Dec 31, 20240%
Accumulated amortization$482.0K5 Dec 31, 2025$278.0K5 Dec 31, 2024+73.4%
Finite-lived intangibles, net$1.9M5 Dec 31, 2025$2.2M5 Dec 31, 2024−9.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$48.9M5 Dec 31, 2025$46.6M5 Dec 31, 2024+5.0%
Raw materials$26.2M5 Dec 31, 2025$28.0M5 Dec 31, 2024−6.3%
Work in process$2.0M5 Dec 31, 2025$3.3M5 Dec 31, 2024−38.7%
Finished goods$20.6M5 Dec 31, 2025$15.3M5 Dec 31, 2024+35.2%

Properties, in its own words

Our corporate headquarters and manufacturing and clinical training facilities are located in Andover, Massachusetts, where we lease 135,199 square feet of space, including a 10,500 square foot laboratory and training facility and a 7,900 square foot ISO Class 7 cleanroom facility. The leases for these facilities expire on December 31, 2027 with an option to extend the term beyond the expiration date for one additional period of five years. On January 8, 2026, we entered into a lease agreement with BioMed Realty for the lease of approximately 498,286 square feet of space located at 188 Assembly Park Drive, Somerville, Massachusetts for our principal executive offices and for research and development, laboratory, manufacturing and assembly, vivarium, office and related uses. The premises is expected to serve as our new headquarters and we expect to transition certain of our operations on or before January 1, 2028, ultimately replacing our existing headquarters in Andover, Massachusetts. Base rent begins to accrue in the first quarter of 2028. The lease will expire one hundred ninety-two (192) months from the date base rent begins to accrue, unless earlier terminated. In connection with our acquisition of Summit, we acquired a 20-year operating lease with one 10-year renewal option, for space at the Bozeman Yellowstone International Airport in Bozeman, Montana where we constructed a commercial aircraft hangar that we use for our flight school aircraft and office space for personnel located in Bozeman. We have a designated maintenance hub for our aircraft in Dallas, Texas under a lease that expires in 2027, subject to certain early termination provisions. We also lease office space at various locations in the United States for our NOP and hangar space for our aircraft under both short-term and long-term leases. We have additional distribution, commercial and research and development operations in Europe.

We believe that these facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space would be readily available on commercially reasonable terms.

Item 2 of the 10-K filed Feb 24, 2026.4

Leadership

Who has led TransMedics Group, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (18)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Northside Property Group, LLC Montana3
  • Summit Aviation, Inc. Montana3
  • TMDX Realty Holdings LLC Delaware3
  • TransMedics GmbH Germany3
  • TransMedics Pty Ltd. Australia3
  • TransMedics S.r.l. Italy3
  • TransMedics, B.V. The Netherlands3
  • TransMedics, Inc. Delaware3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 10, 20268-K Executive or director change; Regulation FD disclosure32
  2. Aug 4, 20268-K Results of operations33
  3. May 21, 20268-K Shareholder vote34
  4. May 5, 20268-K Results of operations35
  5. Feb 27, 20268-K Results of operations36
  6. Feb 24, 20268-K Results of operations37
  7. Feb 4, 20268-K Executive or director change38
  8. Jan 12, 20268-K Entered a material agreement; Other events39
  9. Oct 29, 20258-K Results of operations40
  10. Oct 6, 20258-K Completed an acquisition or sale41
  11. Jul 30, 20258-K Results of operations42
  12. May 23, 20258-K Shareholder vote43
  13. May 1, 2019New chief executive Waleed H. Hassanein becomes CEO13

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.66 a share, on Oct 29, 2025.44

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results33
  2. May 5, 2026Reported quarterly or annual results35
  3. Feb 27, 2026Reported quarterly or annual results36
  4. Feb 24, 2026Reported quarterly or annual results37
  5. Oct 29, 2025Reported quarterly or annual results40
  6. Jul 30, 2025Reported quarterly or annual results42
  7. May 8, 2025Reported quarterly or annual results45
  8. Feb 27, 2025Reported quarterly or annual results46

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

421 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 54 major events, 237 insider forms, 24 large holders, 86 other. The latest 20:

  1. Sep 29, 20263 EDGAR
  2. Sep 14, 20264 EDGAR
  3. Sep 10, 20268-K EDGAR
  4. Aug 17, 20264 EDGAR
  5. Aug 4, 202610-Q EDGAR
  6. Aug 4, 20268-K EDGAR
  7. Jul 14, 20264 EDGAR
  8. Jul 14, 20264 EDGAR
  9. Jul 14, 20264 EDGAR
  10. Jun 17, 20264 EDGAR
  11. Jun 15, 2026144 EDGAR
  12. May 29, 2026SD EDGAR
  13. May 22, 20264 EDGAR
  14. May 22, 20264 EDGAR
  15. May 22, 20264 EDGAR
  16. May 22, 20264 EDGAR
  17. May 22, 20264 EDGAR
  18. May 22, 20264 EDGAR
  19. May 22, 20264 EDGAR
  20. May 21, 20264 EDGAR

The 421 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

177 open-market trades by officers, directors and large owners since October 2021: 6 buys and 171 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 11, 2026Weill DavidDirectorBuy1,336$81.63$109.1KForm 4
Jun 15, 2026Gunderson Thomas J.DirectorSale9,624$75.06$722.4KForm 4
Mar 4, 2026Lovell StephanieDirectorSale1,193$149.62$178.5KForm 4
Mar 4, 2026Weill DavidDirectorSale3,571$146.82$524.3KForm 4
Mar 4, 2026Hernandez GerardoChief Financial OfficerSale7,236$147.21$1.1MForm 4
Mar 2, 2026Hernandez GerardoChief Financial OfficerSale375$139.12$52.2KForm 4
Mar 2, 2026Ranganath Anil P.See remarksSale864$139.12$120.2KForm 4
Mar 2, 2026Corcoran NicholasSee remarksSale2,966$139.12$412.6KForm 4
Dec 4, 2025Hernandez GerardoChief Financial OfficerSale920$139.62$128.4KForm 4
Dec 3, 2025Weill DavidDirectorSale5,000$138.64$693.2KForm 4
Nov 25, 2025Ranganath Anil P.See remarksSale3,000$145.22$435.7KForm 4
Nov 17, 2025Hassanein Waleed HPresident & CEOBuy8,775$114.00$1.0MForm 4
Oct 29, 2025Basile Edward MDirectorSale4,142$130.45$540.3KForm 4
Aug 7, 2025Hassanein Waleed HPresident & CEOBuy8,475$116.25$985.2KForm 4
Aug 6, 2025Hassanein Waleed HPresident & CEOBuy8,400$118.68$996.9KForm 4
Aug 4, 2025Basile Edward MDirectorSale4,143$125.51$520.0KForm 4
Jun 9, 2025Ranganath Anil P.See remarksSale686$139.80$95.9KForm 4
May 27, 2025Basile Edward MDirectorSale5,000$126.45$632.2KForm 4
May 23, 2025Weill DavidDirectorSale732$123.88$90.7KForm 4
May 9, 2025Basile Edward MDirectorSale6,000$115.63$693.8KForm 4

All 177 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Waleed H. Hassanein, M.D.President and Chief Executive Officer57$776.9K$10.9M55
2025Tamer Khayal, M.D.Former Chief Commercial Officer$496.3K$3.8M55
2025Nicholas CorcoranSenior Vice President of Supply Chain and Operations44$451.7K$2.8M55
2025Gerardo HernandezChief Financial Officer55$488.5K$1.6M55
2025Anil RanganathFormer Senior Vice President, General Counsel and Corporate Secretary$412.3K$1.5M55
2024Waleed H. Hassanein, M.D.President and Chief Executive Officer57$688.5K$8.2M55
2024Tamer Khayal, M.D.Former Chief Commercial Officer$474.2K$3.1M55
2024Nicholas CorcoranSenior Vice President of Supply Chain and Operations44$421.2K$2.7M55
2024Gerardo HernandezChief Financial Officer55$17.3K$1.8M55
2024Anil RanganathFormer Senior Vice President, General Counsel and Corporate Secretary$400.0K$594.2K55
2023Waleed H. Hassanein, M.D.President and Chief Executive Officer57$633.8K$6.8M55
2023Tamer Khayal, M.D.Former Chief Commercial Officer$446.0K$2.6M55
2023Nicholas CorcoranSenior Vice President of Supply Chain and Operations44$338.9K$2.5M55
2023Anil RanganathFormer Senior Vice President, General Counsel and Corporate Secretary$215.4K$2.2M55

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.5,596,549$371.7M0.0%+303,218
Fmr LLC5,133,328$341.0M0.0%+37,085
Vanguard Portfolio Management LLC1,933,989$128.5M0.0%+14,454
Vanguard Capital Management LLC1,497,600$99.5M0.0%+19,448
State Street Corp1,420,421$94.3M0.0%+100,942
Nomura Asset Management International Inc.910,495$60.5M0.1%+24,654
Geode Capital Management, LLC894,913$59.5M0.0%+55,758
Hood River Capital Management LLC751,133$49.9M0.4%+51,363
Dimensional Fund Advisors LP610,107$40.5M0.0%+93,428
Braidwell LP609,715$40.5M1.6%+280,324
Goldman Sachs Group Inc559,771$37.2M0.0%−306,511
Citadel Advisors LLC558,824$37.1M0.0%+497,223
Eventide Asset Management, LLC548,874$36.5M0.5%+50
Wellington Management Group Llp515,973$34.3M0.0%+29,500
Emerald Advisers, LLC490,491$32.6M0.8%+147,700
UBS Group AG488,058$32.4M0.0%−92,735
Morgan Stanley405,112$26.9M0.0%−289,038
UBS AM, a distinct business unit of UBS ASSET MANAGEMENT AMERICAS LLC398,250$26.5M0.0%−541,273
Invesco Ltd.394,979$26.2M0.0%−642,995
Citigroup Inc386,066$25.6M0.0%+28,685
Capital World Investors384,671$25.5M0.0%+10,494
Northern Trust Corp368,860$24.5M0.0%+30,701
Charles Schwab Investment Management Inc328,666$21.8M0.0%+9,740
Wasatch Advisors LP308,434$20.5M0.1%−37,710
Zevenbergen Capital Investments LLC308,391$20.5M0.5%+21,870

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How TransMedics Group, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTransMedics Group, Inc.1
  • CIK0001756262
  • Employer ID (EIN)83-21815314
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inMassachusetts4
  • Fiscal year endsDecember 311
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address200 Minuteman Road, Andover, MA 018101
  • Phone97855209001
  • Shares outstanding34,675,145 as of Jul 30, 202612
  • Public float$4.4B as of Jun 30, 20254
  • AuditorPricewaterhouseCoopers LLP, Boston, Massachusetts PCAOB ID 238; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceOct 19, 20181
  • Filings627 in all: 4 (328), 8-K (85), 144 (60), 3 (25), 10-Q (23), SC 13G/A (21), DEFA14A (9), SC 13G (9)1
    All 34 form types

    CORRESP (8), 10-K (7), DEF 14A (7), 424B5 (4), ARS (4), SCHEDULE 13G/A (4), S-1/A (3), S-8 (3), SD (3), UPLOAD (3), 144/A (2), 4/A (2), DRS/A (2), EFFECT (2), SCHEDULE 13G (2), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), DRS (1), DRSLTR (1), S-1 (1), S-1MEF (1), S-3 (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 10, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, No Par ValueTMDXThe Nasdaq Global Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks TransMedics Group, Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 73 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Need for Additional Capital
  • Our financial results may fluctuate from quarter to quarter, which makes our results difficult to predict and may cause our results to fall short of expectations.
  • Our existing and any future indebtedness could adversely affect our ability to operate our business.
  • Servicing our 1.50% convertible senior notes due 2028 requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.
  • We may not have the ability to raise the funds necessary to repurchase the Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the Notes.
  • Capped call transactions entered into in connection with the Notes may impact the value of our common stock.
  • We may not be able to sustain profitability.
  • Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to future limitations.
  • We may need to raise additional funding, which might not be available on favorable terms or at all. Raising additional capital may cause dilution to our shareholders.
  • Risks Related to Product Commercialization and Development
  • Our long-term growth depends on our ability to expand access to the OCS through our NOP.
  • Our long-term growth depends on our ability to improve the OCS platform, including by developing the next generation of our products or expanding into new indications.
The other 63 risks
  • We will need to increase our manufacturing and sterilization capacity in the future and may encounter problems at our manufacturing facility or otherwise.
  • Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
  • We depend heavily on the success of the OCS and it gaining additional market acceptance as well as the success of the next generation OCS. If we are unable to continue to successfully commercialize the OCS or the next generation OCS, our business may fail.
  • We must continue to educate surgeons, transplant centers and private and public payors and demonstrate the merits of the OCS compared with cold storage or new competing technologies.
  • We may not fully realize the anticipated benefits of our completed or future acquisitions, joint ventures, and strategic investments, such transactions may expose us to additional risks.
  • We depend on a limited number of customers for a significant portion of our revenue and the loss of, or a significant shortfall in demand from, these customers could have a material adverse effect on our financial condition and operating results.
  • We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS, and any supply interruption could harm our business.
  • In addition to our aviation transportation services, we also depend on third parties to transport donor organs and medical personnel for our NOP, and limited availability of, or increases in the cost of, transportation could limit our ability to grow or operate the NOP.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our products or services.
  • Price increases of the components used to manufacture our products and supply shortages could adversely affect our business and operating results.
  • Our failure to compete effectively will harm our business and operating results.
  • The clinical trial process that may be required to obtain future regulatory approvals is lengthy and expensive, with uncertain outcomes.
  • Risks Related to Our Transplant Logistics Operations
  • We have limited experience operating aircraft, and we may not be able to achieve the anticipated benefits of our aircraft operations.
  • The operation of aircraft is subject to various risks, and failure to maintain an acceptable safety record may have an adverse impact on our ability to obtain and retain customers.
  • Significant reliance on aircraft manufactured by a single company and spare parts poses risks to our business and prospects.
  • The availability of pilots to the private aviation industries is limited and may negatively affect our operations and financial condition. Increases in our labor costs adversely affect our business, results of operations and financial condition.
  • We are exposed to operational disruptions due to maintenance and third-party services.
  • Significant increases in aviation fuel costs could have a material adverse effect on our business, financial condition and results of operations.
  • Our insurance may become too difficult or expensive to obtain. If we are unable to maintain sufficient insurance coverage, it may materially and adversely impact our results of operations and financial position.
  • The operation of aircraft is often affected by factors beyond our control including: air traffic congestion at airports; air traffic control inefficiencies; increased and changing security measures; changing regulatory and governmental requirements; new or changing travel-related taxes; any of which could have a material adverse effect on our business, results of operations and financial condition.
  • Our aircraft operations are subject to significant governmental regulation and changes in government regulations imposing additional requirements and restrictions on our aircraft operations could increase our operating costs and result in service delays and disruptions.
  • Revocation of permits, approvals, authorizations and licenses.
  • Our aircraft maintenance costs will increase as our fleet ages.
  • We are subject to risks associated with climate change, including the potential increased impacts of severe weather events on our operations and infrastructure.
  • Risks Related to Our Business
  • Failure to maintain an ethical and inclusive corporate culture, or damage to our reputation, could have a material adverse effect on our business.
  • Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches or data corruption could materially disrupt our operations and adversely affect our business and operating results.
  • Economic, political and other risks associated with foreign operations could adversely affect our international sales and our results of operations.
  • Our success depends on our ability to retain our founder and President and Chief Executive Officer and other members of our management team and to attract, retain and motivate qualified personnel.
  • The failure to manage our growth effectively could harm our business.
  • We may experience disruptions to our business as a result of the relocation of our headquarters and general expansion of our operations.
  • Our international expansion may expose us to operational, compliance and financial risks that could adversely affect our business and results of operations.
  • Our use of artificial intelligence, or AI, and other emerging technologies could adversely impact our business and financial results.
  • Risks Related to Our Intellectual Property
  • If we infringe or are alleged to infringe the intellectual property rights of third parties or are otherwise subject to litigation or other proceedings regarding our intellectual property rights, our business or competitive position could be adversely affected.
  • Our industry has experienced substantial litigation and other proceedings regarding patent and other intellectual property rights and lawsuits to protect or enforce our patents and other intellectual property rights could be expensive, time-consuming and unsuccessful.
  • If we are unable to establish, maintain or adequately protect our intellectual property rights relating to the OCS, the commercial value of the OCS will be adversely affected and our competitive position could be harmed.
  • If we are unable to obtain patent term extension under the Hatch-Waxman Act, our business may be materially harmed.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • If we are unable to protect the confidentiality of our trade secrets, the value of the OCS and our business and competitive position could be harmed.
  • We may be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
  • Risks Related to Government Regulation
  • Even after approval for the OCS, we are subject to continuing regulation by regulatory authorities and entities in the United States and other countries, and if we fail to comply with any of these regulations, our business could suffer.
  • Our products have been and may in the future be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
  • If we fail to maintain necessary FDA approvals for the OCS, or obtain necessary FDA approval for future uses of the OCS, we will not be able to commercially sell and market the OCS.
  • If we fail to maintain the CE mark in the European Union, Northern Ireland and the UKCA mark (as applicable) in Great Britain, we will not be able to commercially sell and market the OCS in the EU or UK.
  • If we fail to obtain and maintain regulatory approval in foreign jurisdictions, our market opportunities will be limited.
  • If transplant centers and hospitals cannot obtain adequate reimbursement or funding from governments or third-party payors for purchases of the OCS and additional disposable sets and for costs associated with procedures that use the OCS and the NOP, our prospects for generating revenue and maintaining profitability will suffer materially.
  • Reimbursement in international markets is likely to require us to undertake country-specific reimbursement activities, including additional clinical studies, which could be time-consuming and expensive and may not yield acceptable reimbursement rates.
  • If we modify our products, we may be required to obtain approval of new PMAs or PMA supplements, vary existing CE marking, and may be required to cease marketing or recall any modified products until the required approvals are obtained.
  • If we fail to comply with the FDA’s QSMR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the relevant EU competent authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.
  • We may not be able to obtain or maintain regulatory qualifications outside the United States, which could harm our business.
  • We could face product liability suits or regulatory delays due to defects in the OCS, which could be expensive and time-consuming and result in substantial damages payable by us and increases in our insurance rates.
  • Third parties may attempt to produce counterfeit versions of our products, which may harm our ability to sell the OCS and its components, negatively affect our reputation or harm patients and subject us to product liability.
  • Improper marketing or promotion of our products or misuse or off-label use of the OCS may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Legislative or regulatory reforms in the United States or other jurisdictions may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to manufacture, market or distribute our products after clearance or approval is obtained.
  • We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly.
  • Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws, including the FCPA, as well as export control laws, customs laws, sanctions laws and other laws governing our operations could result in civil or criminal penalties, other remedial measures and legal expenses.
  • We are subject to, and may in the future become subject to additional, U.S., state and foreign laws and regulations imposing obligations on how we collect, store, process or share information concerning individuals. Our actual or perceived failure to comply with such obligations could harm our business. Complying with such laws could also impair our efforts to maintain and expand our customer base, and thereby decrease our revenue.
  • Healthcare policy changes, including recently enacted or potential future legislation reforming the U.S. healthcare system, could harm our business, financial condition and results of operations.
  • Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.
  • U.S. federal government shutdowns could adversely affect our business, financial condition, operating results, cash flows and prospects.
  • Risks Related to Our Common Stock and General Risks
  • The market price of our common stock has been and may continue to be volatile and could subject us to securities class action litigation.
  • If securities or industry analysts issue an adverse or misleading opinion regarding our business or do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.
  • We have adopted anti-takeover provisions in our restated articles of organization and amended and restated bylaws and are subject to provisions of Massachusetts law that may frustrate any attempt to remove or replace our current board of directors or to effect a change of control or other business combination involving our company.
  • Our restated articles of organization designate the Business Litigation Session of the Superior Court of Suffolk County, Massachusetts (or, if and only if the Business Litigation Session of the Superior Court of Suffolk County, Massachusetts lacks jurisdiction, another state or federal court located within the Commonwealth of Massachusetts) as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our shareholders, which could discourage lawsuits against us and our directors and officers.

Legal proceedings

On February 14, 2025, a class action captioned Jewik v. TransMedics Group, Inc., et al., Case No. 1:25-cv-10385, was filed against the Company and certain of its current and former officers in the U.S. District Court for the District of Massachusetts. The complaint purported to assert claims pursuant to Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 promulgated thereunder, seeking unspecified damages on behalf of a putative class of investors who purchased or otherwise acquired the Company’s shares between the Class Period, February 28, 2023 and January 10, 2025.

On April 2, 2025, another purported stockholder filed a putative class action lawsuit against the Company and certain of its current and former officers, also in the U.S. District Court for the District of Massachusetts (Collins v. TransMedics Group, Inc., et al., Case No. 1:25-cv-10778). The Collins complaint alleged claims substantially similar to those alleged in the Jewik action and also sought unspecified damages. On May 22, 2025, the court consolidated the Jewik and Collins actions and appointed the Peace Officers’ Annuity and Benefit Fund of Georgia and Oguzhan Altun as lead plaintiffs, or the Lead Plaintiffs.

The opening of Item 3, Legal Proceedings.4

Sources

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