TMDX 10-K & 10-Q changes, risk factors and insider trading

Our financial results may fluctuate from quarter to quarter due to a number of factors, including the availability of donor organs for transplantation,transplantation and transplant center surgeons, which is unpredictable and could impact the volume of transplant procedures performed at transplant centers using the OCS and demand for our NOP. Our revenue from sales may fluctuate significantly from quarter to quarter, and our future quarterly and annual expenses as a percentage of our revenue may be significantly different from those we have recorded in the past. In addition, thewe timingintend to opportunistically evaluate acquisitions of acquiring additional aircraft for our aviation transportation servicesservices, for which the timing is uncertain and the amount we incur for such acquisitions is likely to differ from quarter to quarter. Our financial results in some quarters may fall below expectations. Comparing our financial results on a period-to-period basis may not be meaningful, and past results may not be an indication of our future performance.

As of December 31, 2024,2025, our outstanding principal balance of long-term debt under our credit agreement with Canadian Imperial Bank of Commerce, or CIBC, was $60.0 million, which we refer to as the CIBC Credit Agreement. Our payment obligations under the CIBC Credit Agreement reduce cash available to fund working capital, capital expenditures, research and development and general corporate needs. In addition, indebtedness under the CIBC Credit Agreement bears interest at a variable rate, making us vulnerable to increases in market interest rates. If market rates increase substantially, we will have to pay additional interest on this indebtedness, which would further reduce cash available for our other business needs. We may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under or refinance our indebtedness under the CIBC Credit Agreement, which is repayable in equal monthly installments starting in July 2026 untiland itsa final payment due at maturity in July 2027.

InPrior recentto years,2024, we havehad incurred significant operating losses and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued customer utilization of our NOP. We generated net income of $190.3 million and $35.5 million for the yearyears ended December 31, 2024.2025 and 2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $468.2$278.0 million.

Our efforts to grow our business have been and may continue to be costlier than we expect. If our operating and capital expenditures are greater than we expect and if our revenue growth is not sufficient to support these expenditures, we will not be able to sustain profitability. We expect our operating and capital expenditures will continue to increase for the foreseeable future as we focus on growing commercial sales of our products in both the U.S. and select non-U.S. markets, including growing our NOP; acquiring and maintaining additional aircraft to support aviation transportation; growingexpanding our commercial team, which will pursue increasing commercial sales ofgrowing our OCS products;NOP, scaling our manufacturing operations;and sterilization operations, continuing research, development and clinical trial efforts, including expanding our research and development and manufacturing capabilities in Italy, seeking regulatory approval for ourthe next generation OCS products, including conducting clinical trials for our next generation OCS products; and seeking regulatory clearance forOCS, new products and product enhancements, including new indications, both in both the U.S.United States and in select non-U.S. markets.markets, establishing and relocating to a new long-term global headquarters, and seeking greater control of air and ground transport for our NOP. The timing and amount of our operating and capital expenditures will depend on many factors, including:

revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions and other products that may be approved in the United States and select non-U.S. markets;

the costs incurredassociated inwith our efforts to operatemaintaining and grow our NOP, including the costs and timing of growing our transplant logistics capabilities, inclusiveincluding by means of acquiringattracting, training and maintainingretaining currentpilots, and additionalthe acquisition, maintenance, or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments;

the costs, timing and outcomes of pre- and post-approval studies and any future clinical studies and regulatory reviews, including to seek and obtain approvals for the next generation of OCS products or for new indications for our OCS products;

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.

As of December 31, 2024,2025, we had federal net operating loss, or NOL, carryforwards of $404.1$370.9 million, which may be available to offset future taxable income, of which $204.6$74.0 million of the total NOL carryforwards expire at various dates throughbeginning 2037,in 2030, while the remaining $199.5$296.9 million do not expire but are limited in their usage to an annual deduction equal to 80% of annual taxable income. As of December 31, 2024,2025, we had state NOL carryforwards of $349.6$261.6 million, which may be available to offset future taxable income and expire at various dates beginning in 2030. As of December 31, 2024,2025, we also had U.S. federal and state research and development tax credit carryforwards of $13.2$7.3 million and $8.3$4.0 million, respectively, which may be available to offset future tax liabilities. Our U.S. federal research and development tax credit carry forwards expire at various dates throughbeginning 2044.in 2026. A material portion of theseour NOL and tax credit carryforwards could expire unused if we do not generate sufficient federal and bestate unavailabletaxable income prior to offsettheir future income tax liabilities.expiration. In addition, a corporation that undergoes an “ownership change,” generally defined in general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs,NOLs and its research and development credit carryforwards and its disallowed interest expense carryovers to offset future taxable income. Our existing NOLs and research and development credit carryforwards may be subject to limitations arising from previousfuture ownership changes. In addition, future changes in our stock ownership, some of which might be beyond our control, could result in an ownership change under Section 382 of the Code. Our NOLs and credits may also bebecome impaired under state law. For these reasons, if we determine that an ownership change has occurredoccurs, or in the event we experience a change of control, we may not be able to utilize a material portion of the NOLs,NOLs and research and development credit carryforwards or disallowed interest expense carryovers incurred prior to 2019.carryforwards.

In order to manufacture the OCS in quantities sufficient to meet our anticipated commercial opportunity, we will need to continue to increase our manufacturing capabilities and retain third parties to sterilize our products. We anticipate that our new headquarters, which we expect to move into on or before January 1, 2028, will meet these increased requirements but we may encounter technical challenges to increasing the scale at which we manufacture the OCS, including with respect to material procurement and quality control and assurance. An increase in production could make it more difficult for us to comply with quality system regulations or other applicable requirements that are currently enforced by the FDA and other regulatory authorities, or that may be introduced in the future, in both the United States and in other countries. Further, we may experience disruptions to our manufacturing as a result of the move to the new headquarters that could potentially limit our production capacity. Commercial scale production of the OCS on a continuing basis also will require us to continue to hire and retain additional management and technical personnel who have the necessary manufacturing experience and skills. We might not successfully identify, hire or retain qualified personnel on a timely basis or at all. To maintain quality of our OCS, we may not be able to scale production of our OCS products at a rate that meets customer demand for our products. Our inability to increase the scale of our manufacturing of the OCS could impair our ability to generate revenue and adversely affect market acceptance of our product.

In addition, all of our manufacturing operations are currently conducted at a single facility in Andover, Massachusetts.Massachusetts and we may continue to conduct certain manufacturing activities at this facility while utilizing additional facilities over time. Any interruption in operations at this location could result in our inability to satisfy product demand. Despite our efforts to safeguard this facility, including acquiring insurance on commercially reasonable terms, adopting environmental health and safety protocols and utilizing off-site storage of computer data, a number of factors could damage or destroy our manufacturing equipment or our inventory of component supplies or finished goods, cause substantial delays in our operations, result in the loss of key information, and cause us to incur additional expenses, including:

Directors of transplant programs are key decision-makers in the adoption of novel medical devices used in organ transplantation. An important part of our commercialization efforts is to educate transplant center program directors and other surgeons on the relative merits of the OCS. Our success depends, in large part, on effectively marketing and educating program directors and other surgeons about the benefits of the OCS and our NOP. Acceptance of the OCS also depends on educating program directors, other surgeons and private and public payors as to the distinctive characteristics, perceived medical and economic benefits, safety, ease of use and cost-effectiveness of the OCS and our NOP. If program directors, other surgeons and private and public payors do not find our body of published clinical evidence and data compelling or wish to wait for additional studies, they may choose not to use or provide coverage and reimbursement for our products and NOP Services. Currently, most universal national healthcare systems outside of the United States do not reimburse transplant centers for the use of the OCSOCS, and reimbursement in international markets may require us to undertake additional clinical studies.

Since our acquisition of Summit, an aviation business, in 2023, we have separately acquired 2122 fixed-wing aircraft, and intend to acquireopportunistically evaluate acquisitions of additional fixed-wing aircraft,aircraft that will be operated as part of our NOP. In addition, in August 2023, we acquired certain assets related to lung and heart perfusion technology from Bridge to Life Ltd. and its subsidiary Tevosol, Inc., or together Bridge to Life. Utilization of these acquired assets may be complex, costly and time consuming and we may face unanticipated issues, expenses and liabilities. We may not successfully or profitably utilize newly acquired assets or integrate, operate, maintain and manage any newly acquired operations or employees. Further development of the assets we acquired from Bridge to Life, or the Bridge to Life Assets, have and will continue to require extensive clinical development, management of nonclinical, clinical and manufacturing activities. In addition, weWe may decide that only certain of the acquired technology is useful for the next generation of the OCS, or that integration of the acquired technology is not feasible or is too costly.

We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS.OCS, and any supply interruption could harm our business.

We rely on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS. For example, each of Fresenius Kabi Austria GmbH and Fresenius Kabi AB, which we refer to collectively as Fresenius, is our single-source supplier of OCS Solutions for the OCS Lung and the OCS Heart, respectively. While we have manufacturing and supply agreements with certain of our suppliers, for most of our suppliers, we place purchase orders on an as-needed basis. Our suppliers could discontinue the manufacturing or supply of these components at any time. We do not carry a significant inventory of some of these components. Our suppliers may not be able to meet our demand for their products, either because of acts of nature, the nature of our agreements with those manufacturers or our relative importance to them as a customer, and our manufacturers may decide in the future to discontinue or reduce the level of business they conduct with us. InIf addition,our ifsingle theseor sole-source suppliers are unable or unwilling to deliver components to us, whether due to a labor shortage, slow down or stoppage, or for any other reason, we may not be able to manufacture or have available one or more products during such period of unavailability and our business could suffer, possibly materially. In such a case, we would be required to seek alternative suppliers. We might not be able to identify and qualify additional or replacement suppliers for any of these components quickly or at all or without incurring significant additional costs. We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all.

Establishing additional or replacement suppliers for any of these materials or components, if required, or any supply interruption from our suppliers, could limit our ability to manufacture our products, result in production delays and increased costs and adversely affect our ability to deliver products to our customers on a timely basis.basis, which could harm our business. Our inability to obtain sufficient quantities of components for the OCS also could adversely affect development of the next generation of the OCS. If we are not able to identify alternate sources of supply for the components, we might have to modify our product to use substitute components, which could lead to additional regulatory obligations that could impact our marketing ability, cause delays in shipments, increase design and manufacturing costs and increase prices for our products. Any such modified product might not be as effective as the predecessor product or might not gain market acceptance. This could lead to customer dissatisfaction and damage to our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

Clinical trials often require enrollment of large numbers of subjects, who may be difficult to identify, recruit and maintain as participants in the clinical trial. As a condition to our PMA approvals, we are required to conduct post-market studies. For example, we have post-approval registries ongoing or completed for all three of our organ products, including the OCS Lung Thoracic Organ Perfusion Registry, or TOP Registry, the OCS Heart Perfusion Registry, or OHP, and the OCS Liver Perfusion Registry, or OLP.

Failure can occur at any stage of clinical testing. For example, our clinical studies may produce negative or inconclusive results, and, in the case of our ENHANCE and DENOVO clinical trials, we may not be successful in demonstrating superiority when compared to static cold storage methods. Additionally, in the future, we may decide, or regulators may require us, to conduct clinical and non-clinical testing in addition to those we have planned. After submission of our PMA applications for OCS Lung and OCS Heart, the FDA requested certain additional clinical analyses, technical information and clarifications as part of the agency’s normal review process. The FDA ultimately approved both PMAs. The FDA could ask us to conduct additional clinical trials or submit additional evidence to support PMA applications in the future. Our failure to adequately demonstrate the safety and effectiveness of any product we may develop in the future would prevent receipt of regulatory clearance or approval and, ultimately, the commercialization of that product or indication for use. Even if our future products are cleared or approved in the United States, commercialization of our products in foreign countries would require marketing authorization from regulatory authorities in those countries. Authorization approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials. Any of these occurrences could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

Risks Related to Our Transplant Logistics Operations

We have limited experience operating aircraft, and we continue to depend on certain members of the former management team of Summit and additional employees we may hire for the successful operation of aviation transportation services and the integration into our NOP services offering. We must comply with applicable laws and regulations to manage our growing NOP transplant logistics network. The operation of aircraft is a highly regulated activity and one that involves unique risks, including those described above, which we have not needed to manage previously. We may not successfully manage these risks or profitably utilize, integrate, operate, maintain and manage our newly acquired aircraft, employees and other aircraft operations.

If we fail to retain certain members of the existing management of Summit, or if we fail to successfully manage our aircraft operations or growing transplant logistics network, our ability to realize the anticipated benefits of the acquisition of Summit or expansion of our NOP may be adversely affected.

As part of our services offered under our NOP, we have acquired a fleet of fixed-wing aircraft. All of the aircraft we currently operate are standardized variants of a singlecertificated model produced by a single manufacturer. Parts and services from this manufacturer are subject to their product and workmanship warranties and capacity to service aircraft. If this manufacturer fails to adequately fulfill its obligations towards us or experiences interruptions or disruptions in production or provision of services due to, for example, bankruptcy, natural disasters, labor strikes or disruption of its supply chain we may experience a significant delay in the delivery of or fail to receive previously ordered parts, which would adversely affect our revenue and results of operations and could jeopardize our ability to meet the demands of our customers. If there is a shortage of replacement parts that are compatible with the model of aircraft we operate, our entire fleet may be impacted and we would not be able to rely on other model aircraft during replacement part shortages or outages. Our operation of a single model of aircraft may therefore limit flexible use of our fleet. Although we could choose to operate aircraft of other manufacturers or increase our reliance on third-party operators, such a change would involve substantial expense to us and could disrupt our business activities.

Our aircraft operations are affected by factors beyond our control, including air traffic congestion at airports, air traffic control inefficiencies and staffing shortages, increased and changing security measures, changing regulatory and governmental requirements, and new or changing travel-related taxes. For example, in November 2024, the FAA announced that a shortage of air traffic controllers had significantly impacted flight traffic. Additionally, U.S. federal government shutdowns have negatively affected the FAA, including causing significant impacts on flight traffic, and any future shutdown could negatively impact our aviation transportation operations. Factors that cause flight delays could prevent us from effectively transporting organs in a timely manner, which could have a material adverse effect on our business, results of operations and financial condition.

We strive to create a culture in which our employees act with integrity, treat each other with respect and consider themselves empowered to report suspected misconduct. Our ability to attract and retain a high-quality workforce depends upon our commitment to a diverse andan inclusive environment, along with our perceived trustworthiness and ethics. Issues can arise in any number of circumstances, including employment-related offenses such as workplace harassment and discrimination, regulatory noncompliance, failure to properly use and protect data and systems, and violations of our employee policies, as well as from actions taken by regulators or others in response to such conduct. Addressing allegations of misconduct detracts focus from business operations and is expensive. We have adopted policies to promote compliance with laws and regulations as well as to foster a respectful workplace for all employees. These policies, which include a code of business conduct and ethics, an insider trading policy, a Regulation FD policy, a sexual harassment policy, a regulated fraternization policy, and a whistleblower policy, are a component of our effort to minimize employee misconduct as well as activities that frequently result in allegations of misconduct. We continuously assess our policies and provide training to our employees, but our employees may fail to abide by these policies. In addition to damaging our reputation, actual or alleged misconduct could affect the confidence of our shareholders, regulators and other parties and could have a material adverse effect on our business, financial condition and operating results.

the burdens of complying with a wide variety of foreign laws and different legal standards, such as anti-bribery laws, including the FCPA, and UK Bribery Act of 2010, or the Bribery Act, data privacy requirements, labor laws and anti-competition regulations;

If any third-party patents were asserted against us, even if we believe such claims are without merit, there is no assurance that a court wouldmay not find in our favor on questions of infringement, validity, enforceability, or priority. A court of competent jurisdiction could hold that the asserted third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize our products. In order to successfully challenge the validity of any U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction wouldmay not invalidate the claims of any such U.S. patent. We may choose or, if we are found to infringe a third party’s patent rights and we are unsuccessful in demonstrating that such patents are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing, and marketing any of our products. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. We also could be forced, including by court order, to cease developing, manufacturing, and commercializing the infringing technology or products. In addition, we could be found liable for significant monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent or other intellectual property right. There could also be public announcements of the results of hearing, motions, or other interim developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations and prospects.

However, we cannot provide any assurances that any of our patents have, or that any of our pending patent applications that mature into issued patents willmay include,not include claims with a scope sufficient to protect our OCS technology, any additional features we develop for our OCS technology or any new products. Other parties may have developed technologies that may be related to or competitive with our system, may have filed or may file patent applications and may have received or may receive patents that overlap or conflict with our patent applications, either by claiming the same methods or devices or by claiming subject matter that could dominate our patent position. The patent positions of medical device companies, including our patent position, may involve complex legal and factual questions, and, therefore, the scope, validity and enforceability of any patent claims that we may obtain cannot be predicted with certainty. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will be advantageous to us. Even if issued, our patents may be challenged, narrowed, held unenforceable, invalidated or circumvented, or others could challenge the inventorship, ownership or enforceability of our patents and patent applications, any of which could limit our ability to stop competitors from marketing similar products or limit the term of patent protection we may have for our products, or cause us to lose our right to manufacture, market and sell the OCS products or components of the OCS products. Additionally, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. In addition, the Leahy-Smith Act has transformed the U.S. patent system into a first-to-file system. The first-to-file provisions became effective on March 16, 2013. It is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. For example, the Leahy-Smith Act provides that an administrative tribunal known as the Patent Trial and Appeals Board, or PTAB, provides a venue for challenging the validity of patents at a cost that is much lower than district court litigation and on timelines that are much faster. Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. Furthermore, an adverse decision in an interference proceeding can result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our products.

others will not develop similar or alternative technologies that do not infringe our patents; any of our patents will be found to ultimately be valid and enforceable;

Depending upon the timing, duration and specifics of FDA marketing approval of our products, one or more of the U.S. patents we own or license may be eligible for limitedpatent term restoration (also referred to as patent term restorationextension) under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years for a patent covering an approved product as compensation for effective patent term lost duringas a result of product development and the FDA regulatory review process. However, even if, at the relevant time, we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to exercise due diligence during the testing phase or regulatory review process, to fail to apply within applicable deadlines or prior to expiration of relevant patents or otherwise to fail to satisfy applicable requirements. Moreover, the time period of the extension or the scope of patent protection afforded could be less than we request.request, for example, if we are found to have failed to exercise due diligence during the testing phase or regulatory review process. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years fromafter approval and only thosepatents claims coveringclaiming the approved product, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or restoration orextension, the term of any such extension is less than we request, or the scope of patent protection is less than we would expect it to be during extension period, the period during which we cancould enforce our patent rights for the applicable product willmay be shortened and our competitors may obtain approval of competing products following our patent expiration.sooner. As a result, our ability to generate revenue could be materially adversely affected. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. If we do not have adequate patent protection or other exclusivity for our products, our business, financial condition or results of operations could be materially adversely affected.

Many of our employees and consultants were previously employed at or engaged by other medical device, biotechnology or pharmaceutical companies, including our competitors or potential competitors, hospitals or other third parties. Some of these employees, consultants and contractors may have executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. Although we try to ensure that our employees and consultants do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these individuals have, inadvertently or otherwise, misappropriated the intellectual property or disclosed the alleged trade secrets or other proprietary information, of these former employers, competitors or other third parties. Additionally, we may be subject to claims from third parties challenging our ownership interest in or inventorship of intellectual property we regard as our own, based on claims that our agreements with employees or consultants obligating them to assign intellectual property to us are ineffective or in conflict with prior or competing contractual obligations to assign inventions to another employer, to a former employer, or to another person or entity. Litigation may be necessary to defend against claims, and it may be necessary or we may desire to enter into a license to settle any such claim; however, there can be no assurance that we wouldmay not be able to obtain a license on commercially reasonable terms, if at all. If our defense to those claims fails, in addition to paying monetary damages or a settlement payment, a court could prohibit us from using technologies, features or other intellectual property that are essential to our products, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. An inability to incorporate technologies, features or other intellectual property that are important or essential to our products could have a material adverse effect on our business and competitive position, and may prevent us from selling our products. In addition, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against these claims, litigation could result in substantial costs and could be a distraction to management. Any litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.

refusing or delaying our requests for premarket approvalPMA of new products or for modifications to existing products, and refusing or delaying our requests for PMAs for new intended uses of the OCS;

Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol but does not apply in Great Britain (England, Wales and Scotland). The UK Medical Devices Regulations 2002 (UK MDR 2002) provided a transitional period under which the UK will recognize EU CE marks and the MHRA has confirmed that this will apply potentially until June 30, 2030 (subjectalthough toa certainconsultation conditionsis andexpected dependingthat onmay thefurther typeextend ofthis deviceperiod). To be placed on the market in Great Britain after this date, medical devices must have undergone a conformity assessment in accordance with the UK MDR 2002 (as amended or replaced) and have the UKCA mark affixed. However, even devices that benefit from the transition period must still comply with the other requirements of the UK MDR 2002; for example, there are broader registration requirements with the Medicines and Healthcare products Regulatory Agency, or the MHRA, and if the manufacturer is located outside the UK, a UK Responsible Person must be appointed. The MHRA is currently consulting on an International Reliance Scheme for UK recognition of international regulatory approvals of certain medical devices, including CE marks.

In addition to these MS-DRG-based payments, Medicare reimburses transplant centers for “reasonable and necessary” organ acquisition costs, which are considered “pass-through” costs distinct from the prospective payment system, and are not based on the payments for the applicable MS-DRG. Pass-through organ acquisition costs include services required for the acquisition of an organ, such as tissue typing, organ preservation, transport of organs, donor evaluation and other acquisition costs. The separate payments for these costs are determined on a reasonable cost basis established through the transplant center’s Medicare cost report. The costs incurred by transplant centers for the organ-specific OCS Console, OCS Perfusion Sets and OCS Solutions are classified as organ acquisition costs for which Medicare provides additional reimbursement. However, Medicare does not reimburse for items determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury. The CMS and Medicare contractors who administer Medicare around the country have substantial discretion in determining whether the OCS is reasonable and necessary in this context. Either CMS or a Medicare contractor might determine that Medicare will not cover and reimburse for the cost of the OCS in the absence of reliable clinical data evidencing the benefits to patients of the use of the OCS. The data we collect from our prior, ongoing and planned clinical studies and patient registry may not be deemed sufficient forto this purpose insupport a coverage determinationfinding by CMS or a Medicare contractor.contractor that use of the OCS is reasonable and necessary such that coverage is warranted. Accordingly, Medicare might not reimburse transplant centers for all or a portion of the cost of the OCS. We believe that private insurers and other public insurers in the United States generally will follow the coverage and payment policies of Medicare.

If we fail to comply with the FDA’s QSR,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.

In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QSR.QMSR. The QSRQMSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices. In February 2024 FDA issued the QSMR Final Rule to amend the QSR, incorporating by reference ISO 13485:2016. Until the QSMR becomes effective on February 2, 2026, and we are required to transition to the QMSR by that date. Prior to February 2, 2026 we are required to comply with the QSR. The FDA enforces the QSRQMSR through periodic inspections and unannounced “for cause” inspections. The QMSR recently replaced the QSR and incorporates by reference ISO 13485:2016. The QSMR became effective on February 2, 2026, at which time we transitioned to the QMSR. Unlike the QSR, the QMSR gives FDA the authority to inspect management review, quality audits, and supplier audit reports.

We are subject to periodic FDA inspections to determine compliance with QSRthe QSMR and pursuant to the Bioresearch Monitoring Program, which have in the past and may in the future result in the FDA issuing Form 483s, including during the conduct of clinical trials. Outside the United States, our products and operations are also often required to comply with standards set by international standards bodies, such as the International Organization for Standardization. For example, in the European Union the MDR includes detailed requirements for clinical investigations, which are in line with the international standard ISO 14155:2020 on good clinical practical, or GCP. Foreign regulatory bodies may evaluate our products or the testing that our products undergo against these standards. The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies. Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements, and the QSRQMSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing our products, refusal to permit the import or export of our product, prohibition on sales of our product, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer.

In the EU, the MDR repealed and replaced the Medical Devices Directive (93/42/EEC) with effect from May,May 2626, 2021. Although the MDR now applies so all new devices placed on the market must be CE marked under it, the transition periods provided by the MDR may extend the validity of the certificates issued by notified bodies for medical devices under the Medical Devices Directive before May 26, 2021 provided that certain conditions are satisfied. As such, devices CE marked under the Medical Devices Directive may continue to be placed on the EU market until the end of December 2027 or 2028 (depending on the class of device) and provided the manufacturer satisfies certain requirements, including that there are no significant changes in the design and intended purpose of these devices. Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol but does not apply in Great Britain (England, Wales and Scotland). The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks under the EU MDR potentially until June 30, 2030 depending on the class of device and subject to certain conditions and depending on the type of device. To be placed on the market in Great Britain after this date, medical devices must have undergone a conformity assessment in accordance with UK legislation and have the UKCA mark affixed.affixed (although the UK Government has announced its intent to consult on the indefinite recognition of the CE mark, which may change the time frame for UKCA mark requirements).

We also recognize that our products may need to be certified and have a UKCA mark affixed to be placed on the market in Great Britain in the future. However, although neither the EU MDR nor EU IVDR apply in Great Britain, the national UK medical devices rules currently allow manufacturers to place devices CE marked under the EU MDR or EU IVDR (including their relevant transition periods) on the market in Great Britain, potentially up until June 30, 2030, depending on the class of device and provided certain conditions are met. The UK Government has recently proposedadopted post-market surveillance legislation and isplans currentlyto consultingadopt on proposedfurther changes to pre-market medical device regulation.regulation in 2026. This might lead to substantial changes in the regulatory framework/requirements imposed on medical devices.devices for the Great Britain market. We will need to continue to monitor the developments in the UK to assess how they impact our devices sold in Great Britain.

the federal Physician Payments Sunshine Act under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred to as the Affordable Care Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and other prescribers and teaching hospitals. Applicable manufacturers are required to submit annual reports to CMS. Failure to submit required information may result in substantial civil monetary penalties;

many countries in which we operate have laws with extra-territorial effect-thoseeffect; those laws apply to our operations outside the relevant country, to the extent they are breached. Examples of such laws include: the FCPA, the Bribery Act and the GDPR. The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state. This is particularly important in the context of bribery offences, which in the UK and in the United States include the offence of bribing a foreign public official. Failure by our sales staff to comply with those laws may result in criminal and civil penalties and damage our reputation; and analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any private payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers,customers; foreign and state laws, including the GDPR, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.

To enforce compliance with the healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. For example, the member states of the European Union closely monitor perceived unlawful marketing activity by companies, including inducement to prescribe and the encouragement of off-label use of devices. Responding to investigations can be time-and resource-consuming and can divert management’s attention from the business. Additionally, as a result of these investigations, healthcare providerscompanies and entitieshealthcare providers may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity and be costly to respond to. If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that apply to us, we may be subject to penalties, including administrative, civil and criminal penalties, damages, fines, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, contractual damages, reputational harm, disgorgement and the curtailment or restructuring of our operations. Moreover, industry associations closely monitor the activities of their member companies. If these organizations or national authorities were to name us as having breached our obligations under their laws, regulations, rules or standards, our reputation would suffer and our business, financial condition, operating results, cash flows and prospects could be adversely affected.

In the conduct of our business, we may at times collect, process or share data concerning individuals, including health-related personal data. The U.S. federal government and various states have adopted or proposed laws, regulations, guidelines and rules for the collection, distribution, use and storage of personal information of individuals. We may also be subject to U.S. federal rules, regulations and guidance concerning cybersecurity for medical devices, including guidance from the FDA. State privacy and cybersecurity laws vary and, in some cases, can impose more restrictive requirements than U.S. federal law. For example, the CCPA affords California residents expanded privacy rights and protections, including civil penalties for violations and statutory damages under a private right of action for data security breaches. These protections were expanded by CPRACPRA, and more than a dozen states now have similar laws. Where state laws are more protective, we must comply with the stricter provisions. In addition to fines and penalties that may be imposed for failure to comply with state law, some states also provide for private rights of action to individuals for misuse of personal information. Our ongoing efforts to comply with evolving laws and regulations may be costly and require ongoing modifications to our policies, procedures and systems. Failure to comply with laws regarding data protection would expose us to risk of enforcement actions and penalties under such laws. Even if we are not determined to have violated applicable data laws, government investigations into these issues can be expensive and lengthy and generate adverse publicity, which could harm our business, financial condition, results of operations or prospects.

The EEA and the UK, as well as other international jurisdictions, also have laws and regulations dealing with the collection, use and processing of personal data concerning individuals who are located there.individuals. Those laws are often more restrictive than thoseanalogous privacy laws in the United States. For example, we are subject to the requirements of the GDPR, which imposes more stringent administrative requirements for controllers and processors of personal data, including, for example, shorteneddemanding timelines for notifying personal data breach notifications,breaches, limitations on retention of personal information, increasedstringent requirements pertaining to the processing of health datadata, andrules regulating pseudonymized (i.e., key-coded) data, additional obligations when we contract with service providers,provider processors, and more robust rights for individuals overwith respect to their personal data. The GDPR also provides that EU member states may make their ownimpose further lawsconditions and regulations, including laws and regulations limitingon the processing of personal data, including genetic, biometric orand health data, which could limit our ability to use and share personal data or cause our costs to increase, and harm our business and financial condition. If we do not comply with our obligations under the GDPR, we could be exposed to enforcement activity from EU regulators, includingwho may impose substantial finesfines, and civil litigation. In addition, EU law restricts transfers of personal data to the United States unless certain requirements are met. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. For example, in July 2020, the Court of Justice of the European Union invalidated the U.S.-EU Privacy Shield Framework, which has ledsince been replaced by the EU-U.S. Data Privacy Framework. There continues to increasedbe heightened scrutiny of data transfers from the EEA and the UK to the United States generallygenerally, as well as other jurisdictions, and this may increase our costs of compliance with data privacy legislation. We rely on a mixture of mechanisms to transfer personal data from our European business to the United States. We are also subject to the laws of each EU member state implementing any EU directive applicable to our processing activities, including Directing 2002/58/EC.

WeAs a result of the UK’s decision to leave the EU (i.e., Brexit), we are subject to the requirements of the UK Data Protection Law as amended and superseded from time to time. UK Data Protection Law means: (i) the GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal) Act 2018; (ii) the UK Data Protection Act 2018; (iii) the UK Privacy and Electronic Communications (EC Directive) Regulations 2003 as they continue to have effect by virtue of section 2 of the European Union (Withdrawal) Act 2018; and (iv) any other laws inpertaining the field ofto data protection in force in the UK from time to time applicable (in whole or in part) to us.

We operate in a highly regulated industry. The U.S. and state governments continue to propose and pass legislation or take administrative action that may affect the availability and cost of healthcare. Healthcare reform initiatives could harm our business, financial condition and results of operations. There is substantial uncertainty as to how, if at all, the current administration will seek to revise the policies of the FDA and other government agencies. While many of the current administration’s proposed policies appear to be focused on deregulation, the administration and federal government could adopt legislation, regulation, or policy that adversely affects our business or creates a more challenging and costly environment to pursue future clinical trials for, or expand commercialization of, our OCS products. Additionally, because one objective of the current administration appears to be to decrease spending in the federal government, the FDA could face staff reductions, which could impact the FDA’s ability to engage in routine regulatory and oversight activities and result in delays or limitations on our ability to proceed with clinical development programs and obtain regulatory approvals. It is difficult to predict how executive actions that may be taken under the current administration may affect the FDA’s ability to exercise its regulatory authority. Inadequate funding for the FDA, SECFDA or other government agencies could impact the timeliness of responses or action and may slow the time necessary for agency reviews, which in turn would have a material adverse effect on our business, financial condition and results of operations In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs and improve access to transplantation. There have been and will likely continue to be ongoing healthcare reform efforts. These reform efforts have and may continue to focus on coverage and payment for organ procurement and transplant. For example, the Centers for Medicare & Medicaid Services issued regulations in 2020 and 2021 that revised Medicare conditions of participation for organ procurement organizations as well as organ acquisition payment policies for organ procurement organizations, transplant centers and donor hospitals. In addition, in 2023, the Securing the U.S. Organ Procurement and Transplantation Network actAct was signed into law, which allows HRSA to makeaward changesmultiple grants, contracts or cooperative agreements to support the Organoperation Procurementof andthe TransplantationOPTN. Network,It oralso OPTN,specifies includingthat requiringthe anawards independentto board,operate the OPTN shall be distinct from awards to support the networks’ board of directors. In September 2024, HRSA began awarding contracts toaimed bothat non-profit and for-profit entities, and eliminatingsupporting the capmulti-vendor on funding.model.

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 United States with a more efficient process to procure donor organs with the OCS. SinceOur 2023, we have offeredtransplant logistics services through our NOP, includinginclude aviation transportation, ground transportation, and other coordination activity. We believe the use of the OCS combined with the NOP has the potential to significantly increase the number of organ transplants and improve post-transplant outcomes We designed the OCS to be a platform that allows us to leverage core technologies across products for multiple organs. To date, we have developed three OCS products, one for each of heart, lung and liver transplantations, making the OCS the only FDA approved, portable, multi-organ, warm perfusion technology platform. All three of our products, OCS Heart, OCS Lung and OCS Liver, have received PMA from the FDA, for both DBD organs and DCD organs.

Prior to 2024, we had incurred significant annual operating losses since inception and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued commercial sales of our products and services. We generated total revenue of $605.5 million and had net income of $190.3 million for the year ended December 31, 2025. We generated total revenue of $441.5 million and had net income of $35.5 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $278.0 million. We expect our operating and capital expenditures will continue to increase as we focus on growing commercial sales of our products in both the United States and select non-U.S. markets. Because of the numerous risks and uncertainties associated with product development, commercialization and regulations of our industry, we are unable to accurately predict the timing or amount of increased expenses or if we will be able to maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve sustained profitability, we may finance our operations through a combination of equity offerings, debt financings and strategic alliances. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we will have to delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to terminate our operations.

The United Network for Organ Sharing, or UNOS, operated the OPTN under a sole-vendor federal contract from 1986 until 2024. In March 2023, the U.S. Department of Health and Human Services’ Health Resources and Services Administration, or HRSA, announced initiatives designed to improve the OPTN, including its intent to solicit contract proposals to manage the OPTN, which is currently operated by the United Network for Organ Sharing, or UNOS,OPTN under a multi-vendor model following the expiration of the sole-vendor contract thatbetween expiredUNOS inand HRSA on March 29, 2024. Additionally, in September 2023, the Securing the U.S. Organ Procurement and Transplantation Network Act was signed into lawlaw. andThis legislation expressly authorizes HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTNOPTN. andIt also specifies that the awards to operate the OPTN shall be operated through awards that are distinct from awards made to support the organization tasked with supporting the networks’ board of directors. In September 2024, HRSA began awarding contracts aimed at supporting these initiatives. The impact that the HRSAmulti-vendor initiatives and the U.S. Organ Procurement and Transplantation Network Act may have on our business, including on our NOP, is uncertain at this time.model.

Inflation, changes in trade policies, and the imposition of or changes in the amount of duties and tariffs have and could continue to adversely impact the price or availability of raw materials, the components of our products as well as shipping and transportation costs. For example, thetariffs related to a small portion of components that we import moderately increased our cost of revenue in 2025. The global economy has experienced extreme volatility and disruptions, including significant volatility in commodity, other material and labor costs, declines in consumer confidence, declines in economic growth, supply chain interruptions, uncertainty about economic stability and record inflation globally. Unfavorable economic conditions have and could continue to result in a variety of risks to our business, including impacts on demand and pricing for our products and pricing and availability of raw materials and components for our products, which could make it difficult to forecast our inventory needs and financial results.

Key Components of Our Results of Operations

We generate net product revenue primarily from sales of our single-use, organ-specific disposable sets used on our organ-specific OCS Consoles. To a lesser extent, we also generate product revenue from the sale of OCS Consoles to customers and the implied rental of OCS Consoles loaned to customers at no charge. For each new transplant procedure, these customers purchase an additional OCS disposable set for use on their existing organ-specific OCS Console. We also generate service revenue by providing outsourced organ procurement, OCS perfusion management and transplant logistics services under our NOP in the United States. With the acquisition of Summit in August 2023, the purchase of fixed-wing transplant aircraft and the addition of a logistics team, we anticipatehave increased service revenue from our transplant logistics services.

Through December 31, 2024, all of2025, our sales outside of the United States have been commercial sales (unrelated to any clinical trials). Our salesSales in the EU are dependent on obtaining and maintaining the CE mark certifications for each of our OCS products. As required by the MDR, we received recertification of the CE mark in September 2022 for each of the OCS Heart and OCS Lung systems, which includes the OCS Console, the OCS disposables, and the OCS solution additives. We also received the recertification of the CE mark in September 2022 for the OCS Liver Console and disposables. We received the CE mark for the OCS Liver combined with our solution additives under the MDR in May 2023, with an effective date of April 2023. In addition, we received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung.

We expect that our revenue will increase over the long term as a result of the continued growth of the NOP in the United States. We also expect that our revenue will increase over the long term as a result of anticipated growth in non-U.S. sales if national healthcare systems begin to reimburse transplant centers for the use of the OCS, if transplant centers utilize the OCS in more transplant cases and if more transplant centers adopt the OCS in their programs. While we expect our revenue to increase over the long term, revenue from sales may fluctuate from quarter to quarter as the timing of organ transplant procedures is generally unpredictable, and we have observed periodic fluctuations in the availability of donor organs,organs and transplant center surgeons, which impacts the volume of transplants.

Cost of net product revenue consists of costs of components of our OCS Consoles and disposable sets, costs of direct materials, labor and the manufacturing overhead that directly supports production and depreciation of OCS Consoles. Included in the cost of OCS disposable sets are the costs of our OCS Lung, OCS Heart and OCS Liver Solutions. Cost of service revenue primarily consists of labor and overhead that directly support organ procurement and OCS perfusion management services and transportation and transplant logistics costs, including labor costs for pilots, aircraft depreciation, aircraft costs, fuel, crew travel, maintenance and third-party flight costs and ground transportation that support organ delivery. For the years ended December 31, 2024 and 2023, cost of service revenue also included approximately $3.1 million and $4.4 million, respectively, of costs related to Summit's legacy operations, unrelated to the NOP and organ transplant.

Research, development and clinical trials expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering,engineering and clinical trialstrial toactivities, continueincluding to develop clinical evidence of our products’ safetysalaries and effectiveness,related regulatorycosts, expenses,including stock-based compensation, facilities costs, laboratory supplies, depreciation, testing, consultantregulatory, servicesdata management and otherconsulting costs associated with our OCS technology platform and OCS products, which include:costs.

Selling, general and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in our commercial team and personnel in executive, marketing, finance and administrative functions, and recruiting and temporary service fees for such personnel. Selling, general and administrative expenses also include direct and allocated facility-related costs, costs to support the NOP, promotional activities, marketing, conferences and trade show costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services and amortization of sales and marketing-related intangible assets. We expect that our selling, general and administrative expenses will increase over the long term as we increase our headcount and infrastructure to support the expected continued sales growth of our OCS products and our NOP.

Interest expense consists of interest expense associated with outstanding borrowings under our loan agreementsagreement and our Notes as well as the amortization of debt discounts associated with such agreements. In July 2022, we entered into a credit agreement with Canadian Imperial Bank of Commerce, or CIBC, under which we borrowed $60.0 million. At that time, we repaid the remaining $35.0 million of principal that had been outstanding under our prior credit agreement with OrbiMed Royalty Opportunities II, LP, or OrbiMed. In May 2023, we issued and sold $460.0 million in aggregate principal amount of our 1.50% convertible senior notes, due 2028.Notes.

Interest income and other income (expense), net includes interest income, realized and unrealized foreign currency transaction gains and losses and other non-operating income and expense items unrelated to our core operations. Interest income consists of interest earned on our invested cash balances. Foreign currency transaction gains and losses result from intercompany transactions as well as transactions with customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded.

We also had service revenue unrelated to OCS transplant of $4.1 million, $4.4 million and $4.9 million for the years ended December 31, 2025, 2024 and 2023, respectively.

Revenue from customers in the United States related to OCS transplant was $421.9$584.7 million in the year ended December 31, 20242025 and increased by $200.5$162.8 million compared to the year ended December 31, 2023,2024, primarily due to higher sales volumes of our OCS Liver and OCS Heart disposable sets. Revenue for each organ in the table above includes net product revenue from sales of disposable sets as well as service revenue for organ procurement, OCS perfusion management and transplant logistics services under the NOP in the United States. EstablishingRevenue the NOP, which launched in late 2021, has allowed us to broaden our customer base and increase utilization of the OCS in organ transplantation. Substantially all of ourfrom customers inoutside the United States nowwas participate$16.7 million and $15.3 million in the NOP.years Byended addingDecember logistics31, to our NOP offering in late 2023, we have been able to further increase product2025 and service2024, revenue.respectively.

Overall gross margin was 59%60% and 64%59% for the years ended December 31, 20242025 and 2023,2024, respectively. The decrease in gross margin from 2023 to 2024 was driven primarily by an increase in service revenue, which has a lower gross margin than product revenue. Gross margin from net product revenue was 79% for each of the years ended December 31, 2025 and 77%2024. Gross margin from service revenue was 29% and 28% for the years ended December 31, 20242025 and 2023, respectively. The increase in product gross margin was primarily as a result of increased sales volume and increased sales of higher margin OCS disposable sets. Gross margin from service revenue was 28% and 29% for the years ended December 31, 2024 and 2023,2024, respectively, and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP. The decrease in service gross margin was primarily due to investments in our NOP network, including aviation-related expenditures, to prepare for future growth. Service revenue gross margin for the year ended December 31, 2023, included the introduction of transportation and logistics services and the integration of Summit.

Total research, development and clinical trials expenses increased by $19.9$13.1 million from $36.1 million in the year ended December 31, 2023 to $56.0 million in the year ended December 31, 2024.2024 to $69.1 million in the year ended December 31, 2025. Personnel related costs increased by $6.4$3.8 million primarily due to increased headcount to support development efforts for our next generation OCS program and overall compensation increases. Personnel related costs included stock-based compensation expense of $4.2$4.7 million and $2.8$4.2 million for the years ended December 31, 20242025 and 2023,2024, respectively. Consulting and third-party services costs increased by $7.1 million due to development efforts by our external development consultants for our next generation OCS, other product development and digital tools. Laboratory supplies and research materials costs increased by $6.1$3.6 million from the year ended December 31, 20232024 to the year ended December 31, 20242025 primarily due to our increased need for supplies and materials used for development of our next generation OCS. Consulting and third-party services costs increased by $2.6 million due to development efforts by our external development consultants for our next generation OCS program and other product development, including our kidney transport system. Clinical trial costs increased by $1.0 million due primarily to the initiation of clinical trial-related activities for our ENHANCE and DENOVO clinical trials. Facility related and other costs increased by $0.9$2.2 million from the year ended December 31, 20232024 to the year ended December 31, 20242025 due primarily to the increased costscost of supporting a larger group of research and development personnel and their development efforts. Clinical trial costs decreased by $0.6 million due to the timing of clinical trials.personnel.

Interest expense was $14.4$13.8 million and $10.8$14.4 million for the years ending December 31, 20242025 and 2023,2024, respectively.respectively, Theand increaseconsisted was due primarily toof interest expense on the $460.0 million principal amount of the Notes,Notes that carry a 1.5% interest rate and interest expense on the $60.0 million principal amount of the CIBC loan that carries a variable interest rate, which werewas issued5.7% inas Mayof 2023.December 31, 2025.

Interest income and other income (expense), net for the years ended December 31, 20242025 and 20232024 included interest income of $13.4$11.4 million and $12.5$13.4 million, respectively, from interest earned on investedcash balances. The decrease in interest income was primarily due to lower yields on our cash balances. OtherInterest income and other income (expense), net also included $1.0 million of realized and unrealized foreign currency transactions gains for the year ended December 31, 2025, and $0.7 million of realized and unrealized foreign currency transactions losses for the year ended December 31, 2024, and $0.3 million of realized and unrealized foreign currency transactions gains during the year ended December 31, 2023.2024.

Prior to 2024, we had incurred significant annual operating losses since inception and we may continue to incur losses in the future. To date, we have funded our operations primarily with proceeds from borrowings under loan agreements, proceeds from the issuance of our Notes, proceeds from the sale of common stock in our public offerings and revenue from commercial sales of our OCS products and NOP services and from sales of our OCS products for use in clinical trials. On May 11, 2023, we issued $460.0 million aggregate principal amount of the Notes in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The total net proceeds from the sale of the Notes, after deducting debt issuance costs of $14.6 million, and purchases of Capped Calls of $52.1 million, were $393.3 million. At December 31, 2024,2025, our principal source of liquidity was cash of $336.7$488.4 million

During the year ended December 31, 2024,2025, net cash used in investing activities of $129.3$59.3 million consisted primarily of purchases of property, plant and equipmentequipment, primarily related to the purchase of $129.7 million, including an increase of $110.2 million in transplant aircraft.

During the year ended December 31, 2023,2024, net cash used in investing activities of $194.0$129.3 million consisted of purchases of property, plant and equipment of $151.8$129.7 million, includingprimarily $141.9related million of transplant-related aircraft purchases,to the purchase of IPR&Dtransplant assets from BTL for $27.2 million and the purchase of Summit for $14.9 million, net of cash received.aircraft.

A conditional conversion feature of the Notes was triggered on JuneDecember 30,31, 2024 and again on September 30, 2024,2025, as the last reported sale price of our common stock was greater than or equal to 130% of the conversion price of the Notes for at least 20 trading days during the period of 30 consecutive trading days ending on and including the last trading day of each of the quartersquarter ended JuneDecember 30,31, 2024 and September 30, 2024, respectively,2025, and the Notes therefore became convertible at the noteholders’ election in the immediatelycalendar followingquarter ending March 31, 2026 (and only during this calendar quarters ended September 30, 2024 and December 31, 2024, respectively.quarter). If this condition or another conversion condition is met in the future, the Notes may again become convertible, otherwise the Notes will be convertible at the noteholders’ election from March 1, 2028 through the close of business on the second scheduled trading day immediately before the maturity date.

Borrowings under the CIBC Credit Agreement bear interest at an annual rate equal to either, at our option, (i) the secured overnight financing rate for an interest period selected by us, subject to a minimum of 1.50%, plus 2.0% or (ii) 1.0% plus the higher of a) the prime rate, subject to a minimum of 4.0% or b) the Federal Funds Effective Rate, plus 0.5%. We are obligated to repay the outstanding principal amount in equal monthly installments commencing in July 2026 with the remaining balance due on the maturity date in July 2027. At our option, we may prepay borrowingsthe outstanding principal amount under the CIBC Credit Agreement, without a prepayment fee. All obligations under the CIBC Credit Agreement are guaranteed by us and each of our material subsidiaries.

All obligations of us and each guarantor are secured by substantially all of our and each guarantor’s assets, including their intellectual property, subject to certain exceptions. Under the CIBC Credit Agreement, we have agreed to customary representations and warranties, events of default and certain affirmative and negative covenants to which we will remain subject until maturity. The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain), as defined, for the trailing four month period (only if EBITDA is negative) and (ii) $10.0 million, and (y) a requirement to maintain total net revenue of at least 75% of the level set forth in the total revenue plan presented to CIBC. The obligations under the CIBC Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in our business), failure to comply with certain covenants and a material adverse change in our business, operations or financial condition. As of December 31, 2024,2025, we were in compliance with all financial covenants of the CIBC Credit Agreement. During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0%. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, CIBC may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, we may be required to prepay the outstanding borrowings,principal amount, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.

As we continue to pursue and increase commercial sales of our OCS products, we expect our costs and expenses to increase in the future, particularly as we expand our commercial team, grow our NOP, scale our manufacturing and sterilization operations, continue research, development and clinical trial efforts, including expanding our research and development and manufacturing capabilities in Italy, seek regulatory approval for the next generation OCS, new products and product enhancements, including new indications, both in the United States and in select non-U.S. markets, establish and relocate to a new long-term global headquarters, and seek greater control of air and ground transport for our NOP. For example, ifIf the demand for our products exceeds our existing manufacturing and sterilization capacity, our ability to fulfill orders would be limited until we have sufficiently expanded such operations. The timing and amount of our operating and capital expenditures will depend on many factors, including:

the costs and expenses of expanding our U.S. and non-U.S. salessales, marketing and marketinglogistics infrastructure and our manufacturing operations;

the costs, timing and outcomes of pre- and post-approval studies or any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products;

the cost and timing of development of the next generation OCS;

the costs associated with maintainingmaintaining, improving and improvingexpanding our commercial operations, including the NOP globally;

the costs associated with maintaining and growing our transplant logistics capabilities, 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;

the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and the level of our selling, general and administrative expenses.

We believe that our existing cash will enable us to fund our operating expenses, capital expenditure requirements, and debt service payments for at least 12 months following the filing of our annual report on Form 10-K. We may need to raise additional funding, which might not be available on favorable terms or at all. See “Item 1A. Risk Factors—Risks Related to Our Financial Position and Need for Additional Capital” in this Annual Report on Form 10-K.

Our contractual obligations include amounts payable as principal and interest payments under the CIBC Credit Agreement. As of December 31, 2024,2025, our outstanding principal balance was $60.0 million, which is repayable in equal monthly installments starting in July 2026 untilwith itsthe remaining balance due on the maturity date in July 2027. We estimate we will pay $3.9$10.0 million in principal payments and $3.4 million in interest payments during 2025.2026. Our estimate of interest payments is based on an assumed rate of 6.4%,5.7%, which was the interest rate in effect at December 31, 2024.2025.

Prior to 2024, we had incurred significant annual operating losses since inception and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued commercial sales of our products and services. We generated total revenue of $173.9$189.9 million and $143.5$363.9 million, and net income of $7.3$14.7 million and $25.7$22.0 million, for the three and six months ended MarchJune 31,30, 2026 and 2025,2026, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $270.6$256.0 million. We expect our operating and capital expenditures will continue to increase as we focus on growing commercial sales of our products in both the United States and select non-U.S. markets. Because of the numerous risks and uncertainties associated with product development, commercialization and regulations of our industry, we are unable to accurately predict the timing or amount of increased expenses or if we will be able to maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve sustained profitability, we may finance our operations through a combination of equity offerings, debt financings and strategic alliances. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we will have to delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to terminate our operations.

AsWe aexpect resultour offull year 2026 effective income tax rate to be between 25% and 27%. The change in the effective tax rate from 2025 relates primarily to the release of our valuation allowance in the fourth quarter of 2025, we expect an increase to our income tax rate in 2026.2025. To the extent allowed, we intend to use our available net operating loss carryforwards and tax credits to reduce cash tax payment obligations.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

We also had service revenue unrelated to OCS transplant of $1.3 million and $0.9$1.0 million for each of the three months ended MarchJune 31,30, 2026 and 2025, respectively.2025.

Revenue from customers in the United States related to OCS transplant was $167.0$183.6 million in the three months ended MarchJune 31,30, 2026 and increased by $28.4$31.4 million compared to the three months ended MarchJune 31,30, 2025, due to higher sales volumes of our OCS Liver disposable sets and increased usage of the NOP. Revenue for each organ in the table above includes net product revenue from sales of disposable sets as well as service revenue for organ procurement, OCS perfusion management and transplant logistics services under the NOP in the United States.

Revenue from customers outside the United States was $5.6$5.2 million and $4.1$4.2 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase was due primarily to higher sales volumes of our OCS Heart disposable sets.

Cost of net product revenue increased by $8.0$6.1 million in the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. Cost of service revenue increased by $9.5$9.8 million in the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. Gross profit increased by $12.9$16.6 million in the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025.

Overall gross margin was 58%60% and 61% for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease in gross margin from 2025 to 2026 was driven primarily by thea higher mix of service revenue, which carries a lower gross margin than product revenue, as well as a decrease in gross margin from product revenue. Gross margin from net product revenue was 77% and 82%80% for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Gross margin from net product revenue decreased from the three months ended MarchJune 31,30, 2025 to the three months ended MarchJune 31,30, 2026 primarily due to product mix and higher freight costs.costs and certain inventory-related costs that we believe are temporary, including strategic stocking costs at hub locations and incremental product costs related to our clinical trials. Gross margin from service revenue was 27%35% and 29%32% for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP. Gross margin from service revenue decreasedincreased during the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 primarily due to increasedefficiencies laborin expenses.our NOP operating model.

Total research, development and clinical trials expenses increased by $7.7$15.7 million from $17.2$15.9 million in the three months ended MarchJune 31,30, 2025 to $24.9$31.6 million in the three months ended MarchJune 31,30, 2026. Personnel related costs increased by $2.2$1.8 million primarily due to increased headcount to support development efforts for our next generation OCS program and overall compensation increases. Personnel related costs included stock-based compensation expense of $1.5$1.1 million and $1.3$1.2 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Consulting and third-party services costs increased by $4.2$10.6 million due to development efforts by our external development consultants for our next generation OCS program and other product development, including our kidneyOCS transportKidney system.device. Clinical trials costs increased by $1.3 million due primarily to patient enrollment in our clinical trials. Facility and IT related and other costs increased by $1.5$1.0 million from the three months ended MarchJune 31,30, 2025 to the three months ended MarchJune 31,30, 2026 due primarily to the increased cost of supporting a larger group of research and development personnel.

Total selling, general and administrative expenses increased by $19.4$13.7 million from $43.6$44.1 million in the three months ended MarchJune 31,30, 2025 to $63.0$57.8 million in the three months ended MarchJune 31,30, 2026 due primarily to increases in personnel related costs and professional and consultant fees, as well as increases in facility related and other and depreciation and amortization expense.2026. Personnel related costs increased by $6.4$3.6 million primarily due to the continued expansion of our team to support the growth in our business. Personnel related costs included stock-based compensation expense of $8.1$7.2 million and $7.3$7.8 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Professional and consultant fees increased by $4.6 million due primarily to increased transaction-related costs of $2.7$1.7 million related to strategic initiatives and corporate development activities, and to process improvement initiatives and market research costs related to international expansion. Professionalexpansion and consultantprocess feesimprovement also included $0.2 million related to headquarters relocation.initiatives. Facility and IT related and other costs increased by $3.5$2.7 million due primarily to increases in IT infrastructureinfrastructure, travel costs and travelproperty costs.tax expenses for properties in Somerville, Massachusetts. Depreciation and amortization expense increased by $4.8$2.6 million primarily due to $2.1 million of amortization of our finance lease for our new headquarters that commenced in January 2026 and $1.9 million of incremental amortization due to a change in estimated useful life of acquired intangible assets.2026.

Interest expense was $7.2 million and $3.5 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Interest expense of $2.5 million and $2.4 million for each of the three months ended MarchJune 31,30, 2026 and 2025, respectively,2025 related to the $460.0 million principal amount of the Notes that carry a 1.5% interest rate. Interest expense of $0.9 million and $1.0 million for each of the three months ended MarchJune 31,30, 2026 and 2025, respectively,2025 related to the $60.0 million principal amount of the CIBC loan that carries a variable interest rate, which was 5.7%6.2% as of MarchJune 31,30, 2026. Additionally, for the three months ended MarchJune 31,30, 2026, interest expense included $3.8 million of imputed interest on our finance lease entered into in January 2026.

Interest income and other income (expense), net for the three months ended MarchJune 31,30, 2026 and 2025 included interest income of $2.7$3.0 million and $2.3$2.5 million, respectively, from interest earned on cash balances. Interest income and other income (expense), net for the three months ended MarchJune 31,30, 2026 and 2025 also included $0.6$0.1 million of realized and unrealized foreign currency transactions losses and $0.5$0.6 million of realized and unrealized foreign currency transactions gains, respectively.

Our effective tax rate of 14%24.3% for the three months ended MarchJune 31,30, 2026 differed from the statutory federal corporate tax rate of 21% primarily due to discrete items occurring during the quarter, primarily excess tax benefits from stock-based compensation, which decreased the effective tax rate, partially offset by state taxesincome and the effect of non-deductible expenses,taxes, which increased the effective tax rate.

For the three months ended MarchJune 31,30, 2025, our income tax expense consisted primarily of state income taxes. Until the fourth quarter of 2025, we maintained a valuation allowance on our overall net deferred tax assets.

Prior to 2024, we had incurred significant annual operating losses since inception and we may incur losses in the future. To date, we have funded our operations primarily with proceeds from borrowings under loan agreements, proceeds from the issuance of our Notes, proceeds from the sale of common stock in our public offerings and revenue from commercial sales of our OCS products and NOP services and from sales of our OCS products for use in clinical trials. At MarchJune 31,30, 2026, our principal source of liquidity was cash of $461.7$472.7 million.

During the threesix months ended MarchJune 31,30, 2026, operating activities provided $24.5$41.8 million of cash, primarily resulting from net income of $7.3$22.0 million and net non-cash charges of $28.6$56.6 million, partially offset by net cash used by changes in our operating assets and liabilities of $11.4$36.8 million. Net cash used by changes in our operating assets and liabilities for the threesix months ended MarchJune 31,30, 2026 consisted primarily of an increase in accounts receivable of $6.5$19.9 million, an increase in inventory of $3.9$10.2 million, and a net decrease in accounts payable and accrued expenses and other current liabilities of $2.0$2.6 million, partiallyan offset by a decreaseincrease in prepaid expenses and other current assets of $2.0$2.4 million and a decrease in operating lease liabilities of $1.6 million.

During the threesix months ended MarchJune 31,30, 2025, operating activities usedprovided $2.9$88.8 million of cash, primarily resulting from net income of $60.6 million and net non-cash charges of $32.4 million, partially offset by net cash used by changes in our operating assets and liabilities of $44.4 million, partially offset by net income of $25.7 million and net non-cash charges of $15.9$4.2 million. Net cash used by changes in our operating assets and liabilities for the threesix months ended MarchJune 31,30, 2025 consisted primarily of an increase in accounts receivable of $44.1$6.6 million andmillion, a net decrease in accounts payable and accrued expenses and other current liabilities of $3.9$2.8 million, and a decrease in operating lease liabilities of $1.4 million, partially offset by decreasesa decrease in inventory of $2.0$5.7 million and a decrease in prepaid expenses and other current assets of $1.9$1.1 million.

During the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities of $36.7$43.7 million consisted of purchases of property, plant and equipment, primarily related to the purchase of two parcels of land and building in Somerville, Massachusetts.

During the threesix months ended MarchJune 31,30, 2025, net cash used in investing activities of $27.0$36.1 million consisted of purchases of property, plant and equipment, primarily related to the purchase of transplant aircraft.

During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities of $3.8$4.7 million consisted primarily of proceeds from the issuance of common stock upon exercise of stock options of $2.2$3.2 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $1.7 million.

During the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities of $3.0$10.1 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $1.7$8.8 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $1.3 million.

Prior to June 8, 2026, the Notes willwere not be redeemable. On or afterAfter June 8, 2026, we may redeem for cash all or any portion of the Notes (subject to the partial redemption limitation set forth in the Indenture), at our option, if the last reported sale price of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption. In addition, calling any Note for redemption will constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption.

All obligations of us and each guarantor are secured by substantially all of our and each guarantor’s assets, including their intellectual property, subject to certain exceptions. Under the CIBC Credit Agreement, we have agreed to customary representations and warranties, events of default and certain affirmative and negative covenants to which we will remain subject until maturity. The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain), as defined, for the trailing four month period (only if EBITDA is negative) and (ii) $10.0 million, and (y) a requirement to maintain total net revenue of at least 75% of the level set forth in the total revenue plan presented to CIBC. The obligations under the CIBC Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in our business), failure to comply with certain covenants and a material adverse change in our business, operations or financial condition. As of MarchJune 31,30, 2026, we were in compliance with all financial covenants of the CIBC Credit Agreement. During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0%. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, CIBC may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, we may be required to prepay the outstanding principal amount, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.

the degree of success we experience in commercializing our OCS products for additional indicationsindications, including OCS Kidney;

the costs, timing and outcomes of pre- and post-approval studies or any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products, including OCS Kidney, or other product candidates, including CHOPS;

There have been no other material changes to our cash requirements from those disclosed in our 2025 Form 10-K.