TransMedics Group (TMDX) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01Our financial results may fluctuate from quarter to quarter, which makes our results difficult to predict and may cause our results to fall short of expectations25% rewritten
2. 02Our existing and any future indebtedness could adversely affect our ability to operate our business
3. 03Servicing 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
4. 04We 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
5. 05In connection with the Notes, we entered into capped call transactions with certain financial institutions. The capped call transactions are expected to generally reduce the potential dilution upon conversion of the Notes into shares of our common stock
6. 06We may not be able to sustain profitability57% rewritten
7. 07the level of our selling, general and administrative expenses
8. 08Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to future limitations75% rewritten
9. 09We 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

1. 10Our long-term growth depends on our ability to expand access to the OCS through our NOP
2. 11Our 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
3. 12develop an effective commercialization effort
4. 13We will need to increase our manufacturing and sterilization capacity in the future and may encounter problems at our manufacturing facility or otherwise23% rewritten
5. 14regional or local power shortages
6. 15Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
7. 16We 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
8. 17We 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
9. 18We 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
10. 19We 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
11. 20We 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
12. 21In 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
13. 22We may not be able to achieve or maintain satisfactory pricing and margins for our products or services
14. 23Price increases of the components used to manufacture our products and supply shortages could adversely affect our business and operating results
15. 24Our failure to compete effectively will harm our business and operating results
16. 25The clinical trial process that may be required to obtain future regulatory approvals is lengthy and expensive, with uncertain outcomes
17. 26our current or future products may have undesirable side effects or other unexpected characteristics

Risks Related to Our Transplant Logistics Operations

1. 27We have limited experience operating aircraft, and we may not be able to achieve the anticipated benefits of our aircraft operations
2. 28The 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
3. 29Significant reliance on aircraft manufactured by a single company and spare parts poses risks to our business and prospects
4. 30The 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
5. 31We are exposed to operational disruptions due to maintenance and third-party services
6. 32Significant increases in aviation fuel costs could have a material adverse effect on our business, financial condition and results of operations
7. 33Our 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
8. 34Our 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
9. 35Revocation of permits, approvals, authorizations and licenses
10. 36Our aircraft maintenance costs will increase as our fleet ages
11. 37We 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

1. 38Failure to maintain an ethical and inclusive corporate culture, or damage to our reputation, could have a material adverse effect on our business
2. 39Failure 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
3. 40Economic, political and other risks associated with foreign operations could adversely affect our international sales and our results of operations
4. 41increased financial accounting and reporting burdens and complexities
5. 42Our 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
6. 43The failure to manage our growth effectively could harm our business
7. 44We may experience disruptions to our business as a result of the relocation of our headquarters and general expansion of our operationsNew
8. 45Our international expansion may expose us to operational, compliance and financial risks that could adversely affect our business and results of operationsNew
9. 46Our use of artificial intelligence, or AI, and other emerging technologies could adversely impact our business and financial resultsNew

Risks Related to Our Intellectual Property

1. 47If 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
2. 48Our 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
3. 49If 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
4. 50If we are unable to obtain patent term extension under the Hatch-Waxman Act, our business may be materially harmed47% rewritten
5. 51We may be unable to enforce our intellectual property rights throughout the world
6. 52If 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

Risks Related to Government Regulation

1. 53Even 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
2. 54Any corrective action, whether voluntary or involuntary, as well as potentially defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results
3. 55Our 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
4. 56If 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
5. 57If 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
6. 58If we fail to obtain and maintain regulatory approval in foreign jurisdictions, our market opportunities will be limited
7. 59Our prospects for generating revenue and maintaining profitability depend heavily upon the availability of adequate reimbursement or funding in both the United States and other markets for purchases of the OCS and for organ transplant procedures that use the OCS and the NOP
8. 60Reimbursement 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
9. 61If 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
10. 62If 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 suffer36% rewritten
11. 63We may not be able to obtain or maintain regulatory qualifications outside the United States, which could harm our business
12. 64We 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
13. 65Third 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
14. 66Legislative 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
15. 67Failure 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 expenses41% rewritten
16. 68Healthcare policy changes, including recently enacted or potential future legislation reforming the U.S. healthcare system, could harm our business, financial condition and results of operations28% rewritten
17. 69Our 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
18. 70U.S. federal government shutdowns could adversely affect our business, financial condition, operating results, cash flows and prospectsNew

Risks Related to Our Common Stock and General Risks

1. 71The market price of our common stock has been and may continue to be volatile and could subject us to securities class action litigation
2. 72sales of large blocks of our stock
3. 73If 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
4. 74Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect our financial condition and results of operations