TransMedics Group, Inc.
For the period ended Mar 31, 2026. Filed May 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-10-29.
0001193125-25-256377
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001193125-26-206453
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 109 previous paragraphs and 109 current paragraphs.
53 unchanged; 33 reworded; 20 added; 17 removed; 6 previous and 3 current paragraphs rearranged.
Tables are not compared: 9 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (20)
Current report
HRSA has consistently exercised options to extend the contract for UNOS to operate OPTN, albeit in a more limited capacity, since March 2024. Most recently, in December 2025, HRSA and UNOS reached a new agreement that took effect on December 30, 2025. This contract allows HRSA to extend UNOS’ work for up to 12 months, until December 29, 2026, structured as four optional three-month periods. The new agreement reflects a shift of several former UNOS functions, including patient safety, reporting and tracking of donor-derived transmission events, and committee support, to HRSA or other contractors.
Current report
Cost of Revenue, Gross Profit and Gross Margin
Current report
Operating Expenses
Current report
Research, development and clinical trials expenses consist of costs incurred for research activities, product development, hardware and software engineering and clinical trial activities, including salaries and related costs, including stock-based compensation, facility and IT related costs, laboratory supplies, depreciation, testing, regulatory, data management and consulting costs.
Current report
Selling, General and Administrative Expenses
Current report
Other Income (Expense)
Current report
Interest Expense
Current report
Income Taxes
Current report
Our (provision) benefit for income taxes is based on applying our forecasted annual effective tax rate to year-to-date income before income taxes, and adjusting for discrete items occurring in the quarter. Our forecasted annual effective tax rate may vary from period to period based on many factors including changes in management’s forecast, deductibility of certain expenses and changes to tax laws.
Current report
As a result of the release of our valuation allowance in the fourth quarter of 2025, we expect an increase to our income tax rate in 2026. To the extent allowed, we intend to use our available net operating loss carryforwards and tax credits to reduce cash tax payment obligations.
Current report
Cost of Revenue, Gross Profit and Gross Margin
Current report
Operating Expenses
Current report
Selling, General and Administrative Expenses
Current report
Total selling, general and administrative expenses increased by $19.4 million from $43.6 million in the three months ended March 31, 2025 to $63.0 million in the three months ended March 31, 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. Personnel related costs increased by $6.4 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 million and $7.3 million for the three months ended March 31, 2026 and 2025, respectively. Professional and consultant fees increased by $4.6 million due primarily to increased transaction-related costs of $2.7 million related to strategic initiatives and corporate development activities, and to process improvement initiatives and market research costs related to international expansion. Professional and consultant fees also included $0.2 million related to headquarters relocation. Facility and IT related and other costs increased by $3.5 million due primarily to increases in IT infrastructure and travel costs. Depreciation and amortization expense increased by $4.8 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.
Current report
Other Income (Expense)
Current report
Interest Expense
Current report
Income Taxes
Current report
Our effective tax rate of 14% for the three months ended March 31, 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 taxes and the effect of non-deductible expenses, which increased the effective tax rate.
Current report
For the three months ended March 31, 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.
Current report
Changes in accounts receivable, inventory, prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities in each reporting period are generally due to growth in our business and timing of invoices and payments.
Removed paragraphs (17)
Previous report
In April 2025, we announced our strategic plan to construct a design center of excellence and new manufacturing facility for our disposable products in Mirandola, Italy. We intend for the facility to initially support the development of the next generation OCS technology platform. Subsequently, we expect that the facility will provide an additional manufacturing source for certain disposable products that are part of the OCS system and provide flexibility in supplying the OCS to international customers. In July we purchased two parcels of land for the construction of our facilities.
Previous report
Since our acquisition of Summit, we have continued to offer flight school training services, consistent with Summit's operations prior to the acquisition. During the three and nine months ended September 30, 2025, service revenue of $1.2 million and $3.1 million, respectively, was from Summit's legacy operations, unrelated to the NOP and organ transplant. During the three and nine months ended September 30, 2024, service revenue of $1.3 million and $3.3 million, respectively, was from Summit's legacy operations, unrelated to the NOP and organ transplant.
Previous report
Research, development and clinical trials expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering, clinical trials to continue to develop clinical evidence of our products’ safety and effectiveness, regulatory expenses, testing, consultant services and other costs associated with our OCS technology platform and OCS products, which include:
Previous report
employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research, hardware and software development, regulatory and clinical trial functions, and recruiting and temporary service fees related to such personnel;
Previous report
expenses incurred in connection with the clinical trials of our products, including under agreements with third parties, such as consultants, contractors and data management organizations;
Previous report
the cost of maintaining and improving our product designs, including the testing of materials and parts used in our products;
Previous report
laboratory supplies and research materials; and
Previous report
facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance.
Previous report
Total selling, general and administrative expenses increased by $3.4 million from $42.7 million in the three months ended September 30, 2024 to $46.0 million in the three months ended September 30, 2025. Personnel related costs increased by $1.0 million primarily due to an increase in stock-based compensation expense of $1.4 million, partially offset by a decrease in personnel costs due to less time spent supporting marketing, finance and administrative activities. Professional and consultant fees increased by $2.3 million due to higher consulting services, which primarily related to general business initiatives to support our growth. Facility related and other costs increased by $1.7 million due primarily to increased depreciation and amortization and information technology infrastructure costs, partially offset by a decrease related to timing of costs related to post-approval studies. Tradeshows and conferences costs also increased by $0.7 million due to increased attendance and exhibition activity at tradeshows and conferences. These increases were partially offset by a decrease in NOP support costs of $2.4 million due to less activity supporting selling, general and administrative functions.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Revenue
Previous report
Revenue from customers outside the United States was $11.9 million and $11.4 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous report
Cost of net product revenue increased by $12.6 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. Cost of service revenue increased by $32.9 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. Gross profit increased by $79.3 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.
Previous report
Overall gross margin was 61% and 59% for the nine months ended September 30, 2025 and 2024, respectively. Gross margin from net product revenue was 80% for each of the nine months ended September 30, 2025 and 2024. Gross margin from service revenue was 30% and 27% for the nine months ended September 30, 2025 and 2024, respectively and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP. Gross margin from service revenue increased during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 primarily due to increased efficiencies in transplant logistics.
Previous report
Total selling, general and administrative expenses increased by $12.0 million from $121.7 million in the nine months ended September 30, 2024 to $133.7 million in the nine months ended September 30, 2025. Personnel related costs increased by $4.6 million primarily due to an increase in stock-based compensation expense of $4.8 million, partially offset by a decrease in personnel costs due to less time spent supporting marketing, finance and administrative activities. Personnel related costs included stock-based compensation expense of $23.1 million and $18.3 million for the nine months ended September 30, 2025 and 2024, respectively. Professional and consultant fees increased by $7.0 million due primarily to increased professional and legal fees related to an independent review of business practices following allegations raised in a short seller report released in January 2025 and, to a lesser extent, higher consulting services related to general business initiatives to support our growth. Facility related and other costs increased by $4.1 million due primarily to increased depreciation and amortization and information technology infrastructure costs. These increases were partially offset by a decrease in NOP support costs of $3.6 million due to less activity supporting selling, general and administrative functions.
Previous report
Interest income and other income (expense), net for the nine months ended September 30, 2025 and 2024 included interest income of $8.1 million and $10.5 million, respectively, from interest earned on cash balances. The decrease in interest income was primarily due to lower yields on our cash balances. Interest income and other income (expense), net for the nine months ended September 30, 2025 and 2024 also included $1.0 million and $0.3 million, respectively, of realized and unrealized foreign currency transactions gains.
Previous report
A conditional conversion feature of the Notes was triggered on June 30, 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 the quarter ended June 30, 2025, and the Notes therefore became convertible at the noteholders’ election in the calendar quarter ended September 30, 2025 (and only during this calendar 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.
Reworded paragraphs (33)
Previous wording
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 Pre-Market Approval, or PMA, from the FDA for both organs donated after brain death, or DBD organs, and organs donated after circulatory death, or DCD organs.
Current wording
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 Pre-Market Approval from the FDA, for both organs donated after brain death, or DBD organs, and organs donated after circulatory death, or DCD organs.
Previous wording
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.
Current wording
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 million and $143.5 million, and net income of $7.3 million and $25.7 million, for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $270.6 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.
Previous wording
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 under a multi-vendor model. At the time, OPTN was operated solely by the United Network for Organ Sharing, or UNOS, under a contract that expired on March 29, 2024. On that date, HRSA extended the contract for UNOS to operate the OPTN for nine months (i.e., until December 29, 2024) with the option for two six-month extensions, potentially extending the contract through December 29, 2025. Additionally, in September 2023, the Securing the U.S. Organ Procurement and Transplantation Network Act was signed into law. This legislation expressly authorizes HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTN. It also specifies that the awards to operate the OPTN shall be distinct from awards to support the networks’ board of directors. In September 2024, HRSA began awarding contracts aimed at supporting the multi-vendor model.
Current wording
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 under a multi-vendor model following the expiration of the sole-vendor contract between UNOS and HRSA on March 29, 2024. Additionally, in September 2023, the Securing the U.S. Organ Procurement and Transplantation Network Act was signed into law. This legislation expressly authorizes HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTN. It also specifies that the awards to operate the OPTN shall be distinct from awards to support the networks’ board of directors. In September 2024, HRSA began awarding contracts aimed at supporting the multi-vendor model.
Previous wording
HRSA continues to implement efforts to improve and modernize the OPTN, including enhancements to patient data on organ procurement, the launch of a publicly accessible data dashboard for allocation out of sequence (AOOS) events, expanded outreach and financial support for living organ donors, and the development of a new OPTN fee collection process whereby HRSA directly collects and distributes patient registration fees under new authorities granted to it by the 2025 Full-Year Continuing Appropriations and Extensions Act. The impact that HRSA's 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.
Current wording
HRSA continues to implement efforts to improve and modernize the OPTN, including enhancements to patient data on organ procurement, expanded transparency through a publicly accessible data dashboard for allocation out of sequence (AOOS) events, expanded outreach and financial support for living organ donors, and a new OPTN fee collection process whereby HRSA directly collects and distributes patient registration fees under authorities originally granted by the 2025 Full-Year Continuing Appropriations and Extensions Act and extended by the 2026 Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act. The impact that HRSA’s 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.
Previous wording
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, we currently expect that tariffs related to a small portion of components that we import will moderately increase 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.
Current wording
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, tariffs 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.
Previous wording
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, 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 Aviation, Inc. and Northside Property Group, LLC, or together, Summit, in August 2023, the purchase of fixed-wing transplant aircraft and the addition of a logistics team, we have increased service revenue from our transplant logistics services.
Current wording
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, 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.
Previous wording
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 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. Cost of service revenue for the three and nine months ended September 30, 2025 also includes $0.7 million and $2.0 million, respectively, of costs from Summit's legacy operations unrelated to the NOP and organ transplant. Cost of service revenue for the three and nine months ended September 30, 2024 includes $0.7 million and $2.4 million, respectively, of costs from Summit's legacy operations unrelated to the NOP and organ transplant.
Current wording
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.
Previous wording
We expect that overall cost of revenue will increase or decrease in absolute dollars primarily as, and to the extent that, our revenue increases or decreases. We expect that the cost of net product revenue as a percentage of net product revenue will moderately decrease and gross margin and gross profit will moderately increase over the long term as our sales and production volumes increase and our cost per unit of our OCS disposable sets decreases due to economies of scale, our product enhancements and improved manufacturing efficiency. We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing processes, which we believe will reduce costs and increase our product gross margin. We also expect to see modest improvements in the future in our services gross margin as we provide more services and the efficiency in provisioning of these services improves due to scale and experience. While we expect our gross margins to increase over the long term, they will likely fluctuate from quarter to quarter.
Current wording
We expect that overall cost of revenue will increase or decrease in absolute dollars primarily as, and to the extent that, our revenue increases or decreases. We expect that the cost of net product revenue as a percentage of net product revenue will moderately decrease and gross margin and gross profit will moderately increase over the long term as our sales and production volumes increase and our cost per unit of our OCS disposable sets decreases due to economies of scale, our product enhancements and improved manufacturing efficiency. We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing processes, which we believe will reduce costs and increase our product gross margin. We also expect to see modest improvements in the future in our services gross margin as we provide more services and the efficiency in provisioning of these services improves due to scale and experience, including effectively managing fluctuating aircraft fuel prices. While we expect our gross margins to increase over the long term, they will likely fluctuate from quarter to quarter.
Previous wording
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 $143.8 million and $444.7 million, and net income of $24.3 million and $84.9 million, for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $383.3 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, including growing our commercial team, which will pursue increasing commercial sales of our OCS products; growing our NOP, including by maintaining and growing our transplant logistics capabilities, including hiring training and retaining pilots to scale our aviation transportation operations, to support our NOP and reduce dependence on third party transportation, including by means of the acquisition, maintenance or replacement of fixed-wing aircraft or other acquisitions, joint ventures or strategic investments; scaling our manufacturing and sterilization operations; developing the next generation OCS; continuing research, development and clinical trial efforts; seeking regulatory clearance for new products and product enhancements, including additional indications or other organs, in both the United States and select non-U.S. markets; and operating as a public company.
Current wording
Research, Development and Clinical Trials Expenses
Previous wording
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.
Current wording
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 and IT 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.
Previous wording
Interest expense consists of interest expense associated with outstanding borrowings under our loan agreement 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. In May 2023, we issued and sold $460.0 million in aggregate principal amount of our Notes.
Current wording
Interest expense consists of interest expense associated with outstanding borrowings under our loan agreement 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. In May 2023, we issued and sold $460.0 million in aggregate principal amount of our Notes. Interest expense also includes imputed interest on our finance lease entered into in January 2026.
Previous wording
We also had service revenue unrelated to OCS transplant of $1.2 million and $1.3 million for the three months ended September 30, 2025 and 2024, respectively.
Current wording
We also had service revenue unrelated to OCS transplant of $1.3 million and $0.9 million for the three months ended March 31, 2026 and 2025, respectively.
Previous wording
Revenue from customers in the United States related to OCS transplant was $139.0 million in the three months ended September 30, 2025 and increased by $34.1 million compared to the three months ended September 30, 2024, due to higher sales volumes of our OCS Liver and OCS Heart 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.
Current wording
Revenue from customers in the United States related to OCS transplant was $167.0 million in the three months ended March 31, 2026 and increased by $28.4 million compared to the three months ended March 31, 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.
Previous wording
Revenue from customers outside the United States was $3.6 million and $2.6 million for the three months ended September 30, 2025 and 2024, respectively.
Current wording
Revenue from customers outside the United States was $5.6 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively. The increase was due primarily to higher sales volumes of our OCS Heart disposable sets.
Previous wording
Cost of net product revenue increased by $5.4 million in the three months ended September 30, 2025 compared to the three months ended September 30, 2024. Cost of service revenue increased by $5.9 million in the three months ended September 30, 2025 compared to the three months ended September 30, 2024. Gross profit increased by $23.7 million in the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Current wording
Cost of net product revenue increased by $8.0 million in the three months ended March 31, 2026 compared to the three months ended March 31, 2025. Cost of service revenue increased by $9.5 million in the three months ended March 31, 2026 compared to the three months ended March 31, 2025. Gross profit increased by $12.9 million in the three months ended March 31, 2026 compared to the three months ended March 31, 2025.
Previous wording
Overall gross margin was 59% and 56% for the three months ended September 30, 2025 and 2024, respectively. Gross margin from net product revenue was 79% and 80% for the three months ended September 30, 2025 and 2024, respectively. Gross margin from service revenue was 28% and 19% for the three months ended September 30, 2025 and 2024, respectively, and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP. Gross margin from service revenue increased during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 primarily due to increased efficiencies in transplant logistics.
Current wording
Overall gross margin was 58% and 61% for the three months ended March 31, 2026 and 2025, respectively. The decrease in gross margin from 2025 to 2026 was driven primarily by the decrease in gross margin from product revenue. Gross margin from net product revenue was 77% and 82% for the three months ended March 31, 2026 and 2025, respectively. Gross margin from net product revenue decreased from the three months ended March 31, 2025 to the three months ended March 31, 2026 primarily due to product mix and higher freight costs. Gross margin from service revenue was 27% and 29% for the three months ended March 31, 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 decreased during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 primarily due to increased labor expenses.
Previous wording
Total research, development and clinical trials expenses increased by $8.9 million from $39.5 million in the nine months ended September 30, 2024 to $48.4 million in the nine months ended September 30, 2025. Personnel related costs increased by $2.5 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 $3.4 million and $3.1 million for the nine months ended September 30, 2025 and 2024, respectively. Laboratory supplies and research materials costs increased by $3.8 million from the nine months ended September 30, 2024 to the nine months ended September 30, 2025, 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 $1.4 million due to development efforts by our external development consultants for our next generation OCS program and other product development. Facility related and other costs increased by $1.0 million due primarily to the increased cost of supporting a larger group of research and development personnel.
Current wording
Total research, development and clinical trials expenses increased by $7.7 million from $17.2 million in the three months ended March 31, 2025 to $24.9 million in the three months ended March 31, 2026. Personnel related costs increased by $2.2 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 million and $1.3 million for the three months ended March 31, 2026 and 2025, respectively. Consulting and third-party services costs increased by $4.2 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. Facility and IT related and other costs increased by $1.5 million from the three months ended March 31, 2025 to the three months ended March 31, 2026 due primarily to the increased cost of supporting a larger group of research and development personnel.
Previous wording
Interest expense was $3.5 million and $3.6 million for the three months ended September 30, 2025 and 2024, respectively, and consisted of interest expense on the $460.0 million principal amount of the 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 was 6.3% in September 2025.
Current wording
Interest expense was $7.2 million and $3.5 million for the three months ended March 31, 2026 and 2025, respectively. Interest expense of $2.5 million and $2.4 million for the three months ended March 31, 2026 and 2025, respectively, 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 the three months ended March 31, 2026 and 2025, respectively, related to the $60.0 million principal amount of the CIBC loan that carries a variable interest rate, which was 5.7% as of March 31, 2026. Additionally, for the three months ended March 31, 2026, interest expense included $3.8 million of imputed interest on our finance lease entered into in January 2026.
Previous wording
Interest income and other income (expense), net for the three months ended September 30, 2025 and 2024 each included interest income of $3.3 million from interest earned on cash balances. Interest income and other income (expense), net for the three months ended September 30, 2025 and 2024 also included $0.1 million of realized and unrealized foreign currency transactions losses and $0.7 million of realized and unrealized foreign currency transactions gains, respectively.
Current wording
Interest income and other income (expense), net for the three months ended March 31, 2026 and 2025 included interest income of $2.7 million and $2.3 million, respectively, from interest earned on cash balances. Interest income and other income (expense), net for the three months ended March 31, 2026 and 2025 also included $0.6 million of realized and unrealized foreign currency transactions losses and $0.5 million of realized and unrealized foreign currency transactions gains, respectively.
Previous wording
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. At September 30, 2025, our principal source of liquidity was cash of $466.2 million.
Current wording
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 March 31, 2026, our principal source of liquidity was cash of $461.7 million.
Previous wording
During the nine months ended September 30, 2024, operating activities provided $29.1 million of cash, primarily resulting from net income of $28.6 and net non-cash charges of $39.7 million, partially offset by net cash used by changes in our operating assets and liabilities of $39.2 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2024 consisted primarily of an increase in accounts receivable of $26.5 million, an increase in inventory of $12.5 million and an increase in prepaid expenses and other current assets of $6.1 million, partially offset by an increase in accounts payable and accrued expenses and other current liabilities of $7.4 million.
Current wording
During the three months ended March 31, 2026, operating activities provided $24.5 million of cash, primarily resulting from net income of $7.3 million and net non-cash charges of $28.6 million, partially offset by net cash used by changes in our operating assets and liabilities of $11.4 million. Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2026 consisted primarily of an increase in accounts receivable of $6.5 million, an increase in inventory of $3.9 million, and a net decrease in accounts payable and accrued expenses and other current liabilities of $2.0 million, partially offset by a decrease in prepaid expenses and other current assets of $2.0 million.
Previous wording
During the nine months ended September 30, 2025, operating activities provided $158.3 million of cash, primarily resulting from net income of $84.9 million, net non-cash charges of $49.7 million, and net cash provided by changes in our operating assets and liabilities of $23.7 million. Net cash provided by changes in our operating assets and liabilities for the nine months ended September 30, 2025 consisted primarily of a decrease in accounts receivable of $17.5 million and an increase in accounts payable and accrued expenses and other current liabilities of $12.8 million, partially offset by an increase in prepaid expenses and other current assets of $4.8 million and a decrease in operating lease liabilities of $2.1 million.
Current wording
During the three months ended March 31, 2025, operating activities used $2.9 million of cash, primarily resulting from 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 million. Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2025 consisted primarily of an increase in accounts receivable of $44.1 million and a net decrease in accounts payable and accrued expenses and other current liabilities of $3.9 million, partially offset by decreases in inventory of $2.0 million and prepaid expenses and other current assets of $1.9 million.
Previous wording
During the nine months ended September 30, 2024, net cash used in investing activities of $115.7 million consisted of purchases of property, plant and equipment, primarily related to the purchase of transplant aircraft. We also received $0.4 million for the final settlement of the Summit purchase price working capital adjustments.
Current wording
During the three months ended March 31, 2026, net cash used in investing activities of $36.7 million consisted of purchases of property, plant and equipment, primarily related to the purchase of two parcels of land and building in Somerville, Massachusetts.
Previous wording
During the nine months ended September 30, 2025, net cash used in investing activities of $43.7 million consisted of purchases of property, plant and equipment, primarily related to the purchase of transplant aircraft.
Current wording
During the three months ended March 31, 2025, net cash used in investing activities of $27.0 million consisted of purchases of property, plant and equipment, primarily related to the purchase of transplant aircraft.
Previous wording
During the nine months ended September 30, 2024, net cash provided by financing activities of $21.7 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $19.6 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $2.1 million.
Current wording
During the three months ended March 31, 2026, net cash provided by financing activities of $3.8 million consisted primarily of proceeds from the issuance of common stock upon exercise of stock options of $2.2 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $1.7 million.
Previous wording
During the nine months ended September 30, 2025, net cash provided by financing activities of $13.8 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $10.6 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $3.2 million.
Current wording
During the three months ended March 31, 2025, net cash provided by financing activities of $3.0 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $1.7 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $1.3 million.
Previous wording
Before March 1, 2028, noteholders have the right to convert their Notes only upon the occurrence of certain events, including certain corporate events, and during the five business days immediately after any ten consecutive trading days in which the trading price per $1,000 principal amount of Notes is less than ninety-eight percent (98%) of the as converted value. Additionally, the noteholder can convert their Notes during any calendar quarter (and only during such calendar quarter), commencing after the calendar quarter ending on September 30, 2023 but before March 1, 2028, provided the last reported sale price of the common stock for at least 20 trading days is greater than or equal to 130% of the conversion price during the 30 consecutive trading days ending on the last trading day of a calendar quarter. From and after March 1, 2028, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. We have the right to elect to settle conversions either in cash, shares or in a combination of cash and shares of our common stock.
Current wording
Before March 1, 2028, noteholders have the right to convert their Notes only upon the occurrence of certain events, including certain corporate events, and during the five business days immediately after any ten consecutive trading days in which the trading price per $1,000 principal amount of Notes is less than ninety-eight percent (98%) of the as converted value. Additionally, noteholders can convert their Notes during any calendar quarter (and only during such calendar quarter), commencing after the calendar quarter ending on September 30, 2023 but before March 1, 2028, provided the last reported sale price of the common stock for at least 20 trading days is greater than or equal to 130% of the conversion price during the 30 consecutive trading days ending on the last trading day of a calendar quarter. From and after March 1, 2028, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. We have the right to elect to settle conversions either in cash, shares or in a combination of cash and shares of our common stock.
Previous wording
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 borrowings 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 outstanding borrowings 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.
Current wording
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 the 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.
Previous wording
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 September 30, 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 outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.
Current wording
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 March 31, 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.
Previous wording
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 to Italy, seek regulatory approval for new products and product enhancements, including new indications, both in the United States and in select non-U.S. markets, and seek greater control of air and ground transport for our NOP. For example, if 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:
Current wording
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. If 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:
Previous wording
the costs, timing and outcomes of post-approval studies or any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products;
Current wording
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, or other product candidates, including CHOPS;
Previous wording
the cost of development of the next generation OCS;
Current wording
the cost and timing of development of the next generation OCS;
Previous wording
There have been no material changes to our cash requirements from those disclosed in our 2024 Form 10-K. In July 2025, we purchased two parcels of land in Mirandola, Italy. We plan to construct research and development and manufacturing facilities but have not yet entered into constructions contracts.
Current wording
There have been no material changes to our cash requirements from those disclosed in our 2025 Form 10-K.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Interest Income and Other Income (Expense), Net
Current report — wording carried from elsewhere
Research, Development and Clinical Trials Expenses
Current report — wording carried from elsewhere
Interest Income and Other Income (Expense), Net
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
Total research, development and clinical trials expenses increased by $1.0 million from $14.3 million in the three months ended September 30, 2024 to $15.3 million in the three months ended September 30, 2025. Personnel related costs increased by $1.0 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 $0.9 million and $1.1 million for the three months ended September 30, 2025 and 2024, respectively. Facility related and other costs increased by $0.4 million primarily due to the increased cost of supporting a larger group of research and development personnel. These increases were partially offset by a decrease in consulting and third-party services costs of $0.4 million, primarily due to timing of costs related to our development efforts.
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
OCS transplant-related revenue consisted of:
Previous report — wording carried elsewhere
We also had service revenue unrelated to OCS transplant of $3.1 million and $3.3 for the nine months ended September 30, 2025 and 2024, respectively.
Previous report — wording carried elsewhere
Revenue from customers in the United States related to OCS transplant was $429.8 million in the nine months ended September 30, 2025 and increased by $124.6 million compared to the nine months ended September 30, 2024, due to higher sales volumes of our OCS Liver and OCS Heart 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.
Previous report — wording carried elsewhere
Interest expense was $10.4 million and $10.8 million for the nine months ended September 30, 2025 and 2024, respectively, and consisted of interest expense on the $460.0 million principal amount of the 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 was 6.3% in September 2025.