TransMedics Group, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on March 11, 2021 (“2020 Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Item 1A. Risk Factors” section of this Quarterly Report on Form 10-Q and the “Item 1A. Risk Factors” section of our 2020 Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Overview We are a commercial-stage 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 believe our substantial body of clinical evidence has demonstrated the potential for the OCS to significantly increase the number of organ transplants and improve post-transplant outcomes. We developed the OCS to comprehensively address the major limitations of cold storage. The OCS is a portable organ perfusion, optimization and monitoring system that utilizes our proprietary and customized technology to replicate near-physiologic conditions for donor organs outside of the human body. We designed the OCS technology platform to perfuse donor organs with warm, oxygenated, nutrient-enriched blood, while maintaining the organs in a living, functioning state; the lung is breathing, the heart is beating and the liver is producing bile. Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and offers the potential to significantly improve donor organ utilization. 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 lung, heart and liver transplantations, making the OCS the only multi-organ technology platform. We have commercialized the OCS Lung and OCS Heart outside of the United States and received our first Pre-Market Approval (“PMA”) from the Food and Drug Administration (the “FDA”) in March 2018 for the use in the United States of the OCS Lung for donor lungs currently utilized for transplantation and a PMA from the FDA in May 2019 for the use in the United States of the OCS Lung for donor lungs currently unutilized for transplantation. Since our inception, we have focused substantially all of our resources on designing, developing and building our proprietary OCS technology platform and organ-specific OCS products; obtaining clinical evidence for the safety and effectiveness of our OCS products through clinical trials; securing regulatory approval; organizing and staffing our company; planning our business; raising capital; commercializing our products; developing our market and distribution chain and providing general and administrative support for these operations. To date, we have funded our operations primarily with proceeds from sales of preferred stock and borrowings under loan agreements, proceeds from the sale of common stock in our initial public offering, or IPO, the sale of our common stock in follow-on equity offerings, and revenue from clinical trials and commercial sales of our OCS products. Since our inception, we have incurred significant operating losses. Our ability to generate net revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products. We generated net revenue of $15.2 million and incurred a net loss of $18.6 million for the six months ended June 30, 2021. We generated net revenue of $25.6 million and incurred a net loss of $28.7 million for the year ended December 31, 2020. As of June 30, 2021, we had an accumulated deficit of $416.8 million. We expect to continue to incur net losses for the foreseeable future as we focus on growing commercial sales of our products in both the United States and select non-U.S. markets, including growing our sales and clinical adoption team, which will pursue increasing commercial sales and clinical adoption of our OCS products; scaling our manufacturing operations; continuing research, development and clinical trial efforts; seeking regulatory clearance for new products and product enhancements, including new indications, in both the United States and select non-U.S. markets; and operating as a public company. As a result, we will need substantial additional funding for expenses related to our operating activities, including selling, general and administrative expenses and research, development and clinical trials expenses. 21 Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Until such time, if ever, as we can generate substantial net revenue sufficient to achieve profitability, we expect to 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 may have to significantly delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to reduce or terminate our operations. We believe that our cash and cash equivalents and marketable securities will be sufficient for us to fund our operating expenses, capital expenditure requirements and debt service payments for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources”. COVID-19 The impact of the COVID-19 pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Impacts to our business as a result of COVID-19 include: the temporary disruption of transplant procedures at many of the organ transplant centers who purchase OCS products; customer delays or reductions in customer capital expenditures and operating budgets and the related impact on our product sales; disruptions to our manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts; labor shortages; decreased productivity and unavailability of materials or components; restrictions on or delays of our clinical trials and studies; delays of reviews and approvals by the FDA and other health authorities , including with respect to the Company’s OCS Heart PMA application ; limitations on our employees’ and customers’ ability to travel; and delays in product installations, trainings or shipments to and from affected countries and within the United States. In addition, o ur sales and clinical adoption team was restricted in visiting many transplant centers in person between April 2020 and September 2020. In response to the pandemic, healthcare providers have, and may need to further, reallocate resources, such as physicians, staff, hospital beds and intensive care unit facilities, and these actions significantly delay the provision of other medical care such as organ transplantation and reduce the number of transplant procedures that are performed, which has a negative impact on our revenue and clinical trial activities. In April 2020, we announced several steps to respond to the COVID-19 pandemic intended to protect the health and safety of our employees, to establish a process to support the continuous supply of our OCS products at transplant centers globally and to maintain financial flexibility. These actions included transitioning most employees to a remote work environment, except for those who are deemed essential to product supply, and reducing near-term expenses, such as reducing non-essential discretionary expenses and deferring a portion of executive and employee compensation from April 2020 through August 31, 2020. OCS product sales were negatively impacted by the COVID-19 pandemic from the second quarter of 2020 through the second quarter of 2021 and we anticipate a negative impact to OCS product sales to continue through 2021. We have observed recovery in the overall frequency of transplant procedures to pre-pandemic levels in most countries during the most recent quarter. In addition, while the number of transplant procedures performed declined during the COVID-19 pandemic, organ transplantations are non-elective, life-saving procedures and we believe that the need for these procedures has persisted and will continue to persist as demonstrated by procedure recovery. We continue to monitor developments regarding the COVID-19 pandemic and its impact on our business, financial condition, results of operations and prospects. The extent of the future impact on our operations and financial condition is difficult to predict and will depend on the length and severity of the pandemic, its consequences, and containment and vaccination efforts. In particular, the speed of the continued spread of COVID-19 globally, and the magnitude, duration and frequency of interventions to contain the spread of the virus, such as government-imposed quarantines, including shelter-in-place mandates, sweeping restrictions on travel, mandatory shutdowns for non-essential businesses, requirements regarding social distancing, and other public health safety measures, will determine the impact of the pandemic on our business. While the FDA approved emergency use authorization of vaccines starting in December 2020 and vaccination efforts have been ongoing in the United States, it is not yet fully known how vaccination efforts will impact the COVID-19 pandemic, including with respect to the duration of the efficacy of the vaccines, their effectiveness against the Delta variant or any other variants as new strains of the virus evolve. . Recent Developments On July 14, 2021, the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee convened for an advisory committee meeting to review our clinical evidence from the OCS Liver PROTECT Trial and to provide the FDA with non-binding recommendations with respect to our OCS Liver PMA application. At the advisory committee meeting, the panel voted: 14 to zero that the OCS Liver is safe for patients; 14 to zero that the OCS Liver is effective for use in patients; and 12 to one (with one panel member abstaining) that the benefits of the OCS Liver outweigh its risks. We anticipate the FDA will issue a decision regarding whether to approve or deny approval of our OCS Liver PMA application within three to four months following the advisory committee meeting, which decision may or may not follow the advisory committee’s recommendation. 22 On July 30, 2021, the FDA provided a 510(k) clearance for use of the OCS Lung Solution in lung transplantations using cold storage. Components of Our Results of Operations Net Revenue We generate revenue primarily from sales of our single-use, organ-specific disposable sets (i.e., our organ-specific OCS Perfusion Sets sold together with our organ-specific OCS Solutions) used on our organ-specific OCS Consoles, each being a component of our OCS products. To a lesser extent, we also generate revenue from the sale of OCS Consoles to customers and from 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 the customer’s existing organ-specific OCS Console. All of our revenue has been generated by sales to transplant centers in the United States, Europe and Asia-Pacific, or, in some cases, to distributors selling to transplant centers in select countries. Substantially all of our customer contracts have multiple-performance obligations that contain promises consisting of OCS Perfusion Sets and OCS Solutions. In some of those contracts, the promises also include an OCS Console, whether sold or loaned to the customer. Some of our revenue has been generated from products sold in conjunction with the clinical trials conducted for our OCS products, under arrangements referred to as customer clinical trial agreements. Under most of these customer clinical trial agreements, we place an organ-specific OCS Console at the customer site for its use free of charge for the duration of the clinical trial, and the customer separately purchases from us the OCS disposable sets used in each transplant procedure during the clinical trial. When we loan the OCS Console to the customer, we retain title to the console at all times and do not require minimum purchase commitments from the customer related to any OCS products. In such cases, we invoice the customer for OCS disposable sets based on customer orders received for each new transplant procedure and the prices set forth in the customer agreement. Over time, we typically recover the cost of the loaned OCS Console through the customer’s continued purchasing and use of additional OCS disposable sets. For these reasons, we have determined that part of the selling price for the disposable set is an implied rental payment for use of the OCS Console. We continue to loan OCS Consoles to some of our customers during commercialization of our OCS products. Because all promises of a customer contract are delivered and recognized as revenue at the same time and because revenue allocated to promises other than OCS disposable sets, such as implied rental income and service revenue, is insignificant, all performance obligations from customer contracts are classified as a single category of revenue in our consolidated statements of operations. Under some of our customer clinical trial agreements, we make payments to our customers for reimbursements of clinical trial materials and for specified clinical documentation related to their use of our OCS products. Because some of these payments do not provide us with a separately identifiable benefit, we record such payments as a reduction of revenue from the customer, resulting in our net revenue presentation. We recorded reimbursable clinical trial costs as a reduction of revenue of $0.5 million and $1.1 million for the three and six months ended June 30, 2021, respectively, and $0.5 million and $1.2 million for the three and six months ended June 30, 2020. In March 2018, we received our first FDA PMA for the OCS Lung, and we began commercial sales of this product in the United States during the fourth quarter of 2018. In May 2019, we received an FDA PMA for the OCS Lung for additional clinical indications. Therefore, our net revenue in the United States for the OCS Lung is now derived from commercial sales and consists of sales of OCS disposable sets and, to a much lesser extent, sales of OCS Consoles. In the United States, we expect to continue to only have clinical trial sales for our OCS Heart and OCS Liver products until we receive similar FDA PMAs for those products. Our net revenue in the United States for OCS Heart and OCS Liver products fluctuates from period to period as a result of the timing of patient enrollment in our clinical trials. Historically, our net revenue during periods of patient enrollment has been higher due to the sale of OCS disposable sets for use during these clinical trials, as compared to periods during which our clinical trials were not actively enrolling. Our OCS Heart EXPAND CAP trial began patient enrollment in May 2019 and is currently enrolling patients. Our OCS Liver PROTECT CAP trial began patient enrollment in February 2020 and completed initial enrollment in the first quarter of 2021. Our net revenue may continue to fluctuate from period to period as a result of the timing of ongoing clinical trials in which our OCS products are used. Through June 30, 2021, all of our sales outside of the United States have been commercial sales (unrelated to any clinical trials) and our net revenue has been generated primarily from sales of OCS disposable sets and, to a much lesser extent, sales of OCS Consoles. Commercial sales of OCS disposable sets generally have a higher average selling price than clinical trial sales of OCS disposable sets. 23 We expect that our net revenue will increase over the long term as a result of receiving our first two FDA PMA s for the OCS Lung in the United States in March 2018 and May 2019 and any potential future FDA approvals in the United States for OCS Heart and OCS Liver . We expect to receive decision s from the FDA regarding whether to approve the PMA for the use of the OCS Heart and OCS Liver in the United States in 2021 following the advisory committee meeting s held on April 6, 2021 and July 14, 2021, respectively . We also expect that our net 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, in all served geographies, if transplant centers utilize the OCS in more transplant cases, and if more transplant centers adopt the OCS in their programs. We expect that net revenue will continue to be negatively impacted in 2021 a result of the COVID-19 pandemic. Cost of Revenue, Gross Profit and Gross Margin Cost of revenue consists primarily 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 costs related to the depreciation of OCS Consoles loaned to customers. When we loan an OCS Console to a customer for its use free of charge, we capitalize as property and equipment the cost of our OCS Console and depreciate these assets over the five-year estimated useful life of the console. Included in the cost of OCS disposable sets are the costs of our OCS Lung, OCS Heart and OCS Liver Solutions. We expect that cost of revenue will increase or decrease in absolute dollars primarily as, and to the extent that, our net revenue increases or decreases. Gross profit is the amount by which our net revenue exceeds our cost of revenue in each reporting period. We calculate gross margin as gross profit divided by net revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily production volumes, the cost of components and direct materials, manufacturing overhead costs, headcount, the selling price of our OCS products and fluctuations in amounts paid by us to customers related to reimbursements of their clinical trial expenses. We expect that cost of revenue as a percentage of net revenue will decrease and gross margin and gross profit will 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. 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 gross margin. As utilization by customers of our OCS products increases, we expect that a greater number of OCS disposable sets will be used per year on the same OCS Console, thereby driving overall gross margin improvement. Because we expect that the number of OCS disposable sets sold over time will be significantly greater than the number of OCS Consoles sold or loaned to customers over that same period, we expect that our gross margin improvement will not be significantly affected by the number of OCS Consoles that we sell or loan to customers. While we expect gross margin to increase over the long term, it will likely fluctuate from quarter to quarter. Operating Expenses Research, Development and Clinical Trials Expenses Research, development and clinical trials expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering, clinical trials 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: • 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; • 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; • the cost of maintaining and improving our product designs, including the testing of materials and parts used in our products; • laboratory supplies and research materials; and • facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance. We expense research, development and clinical trials costs as incurred. In the future, we expect that research, development and clinical trials expenses will increase over the long term due to ongoing product development and approval efforts. We expect to continue to perform activities related to obtaining additional regulatory approvals for expanded indications in the United States and other served geographies, as well as developing the next generation of our OCS technology platform. 24 Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in our sales and clinical adoption team and personnel in executive, marketing, finance and administrative functions. Selling, general and administrative expenses also include direct and allocated facility-related costs, promotional activities, marketing, conferences and trade shows as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We expect to continue to increase headcount in our sales and clinical adoption team and increase marketing efforts as we continue to grow commercial sales of our OCS products in both U.S. and select non-U.S. markets. We expect that our selling, general and administrative expenses will increase over the long term as we increase our headcount to support the expected continued sales growth of our OCS products. We also anticipate that we will continue to incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with our continued operation as a public company. Other Income (Expense) Interest Expense Interest expense consists of interest expense associated with outstanding borrowings under our loan agreement as well as the amortization of debt discount associated with such agreement. Other Income (Expense), Net 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. Provision for Income Taxes Since our inception, we have not recorded any U.S. federal or state income tax benefits for the net operating losses we have incurred in each year or for the research and development tax credits we generated in the United States, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. In reporting periods subsequent to 2016, we have recorded provisions for foreign income taxes of an insignificant amount related to the operations of one of our foreign subsidiaries. As of December 31, 2020, we had U.S. federal and state net operating loss carryforwards of $322.0 million and $252.7 million, respectively, which may be available to offset future taxable income and begin to expire in 2021 and 2030, respectively. Our federal net operating losses include $108.0 million, which can be carried forward indefinitely. As of December 31, 2020, we also had U.S. federal and state research and development tax credit carryforwards of $7.6 million and $5.0 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2021 and 2024, respectively. As of December 31, 2020, we had no foreign net operating loss carryforwards. We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date. 25 Results of Operations Comparison of the Three Months Ended June 30, 2021 and 2020 The following table summarizes our results of operations for the three months ended June 30, 2021 and 2020: Three Months Ended June 30, 2021 2020 Change (in thousands) Net revenue $ 8,171 $ 3,391 $ 4,780 Cost of revenue 2,582 1,482 1,100 Gross profit 5,589 1,909 3,680 Operating expenses: Research, development and clinical trials 6,295 3,903 2,392 Selling, general and administrative 9,162 5,867 3,295 Total operating expenses 15,457 9,770 5,687 Loss from operations (9,868 ) (7,861 ) (2,007 ) Other income (expense): Interest expense (965 ) (1,001 ) 36 Other income (expense), net 171 371 (200 ) Total other expense, net (794 ) (630 ) (164 ) Loss before income taxes (10,662 ) (8,491 ) (2,171 ) Provision for income taxes (6 ) (6 ) — Net loss $ (10,668 ) $ (8,497 ) $ (2,171 ) Net Revenue Three Months Ended June 30, 2021 2020 Change (in thousands) Net revenue by geography: United States $ 5,758 $ 2,440 $ 3,318 Outside the U.S. 2,413 951 1,462 Total net revenue $ 8,171 $ 3,391 $ 4,780 Net revenue by OCS product: OCS Lung net revenue $ 3,572 $ 435 $ 3,137 OCS Heart net revenue 4,599 2,220 2,379 OCS Liver net revenue — 736 (736 ) Total net revenue $ 8,171 $ 3,391 $ 4,780 Net revenue from customers in the United States was $5.8 million in the three months ended June 30, 2021 and increased by $3.3 million compared to the three months ended June 30, 2020, primarily due to higher sales volumes of our OCS Lung and OCS Heart disposable sets. Net revenue from sales of OCS Lung disposable sets in the United States increased from $0.4 million in the three months ended June 30, 2020 to $3.5 million in the three months ended June 30, 2021. The increase was due primarily to higher sales volume of OCS Lung disposable sets as the adverse impact of COVID-19 had less of an impact in the 2021 period. Net revenue from OCS Heart disposable sets in the United States increased by $1.0 million. The increase in net revenue from OCS Heart disposable sets is attributed to a higher volume of OCS Heart disposable sets sold to customers for use in the OCS Heart DCD CAP Trial in the United States. We did not have revenue from OCS Liver disposable sets during the three months ended June 30, 2021 as we had completed enrollment in our OCS Liver Protect CAP Trial in the first quarter of 2021. Net revenue from customers outside the United States was $2.4 million in the three months ended June 30, 2021 compared to $1.0 million in the three months ended June 30, 2020. The increase in net revenue from customers outside the United States was primarily due to higher sales volumes of OCS Heart and OCS Lung disposable sets. Net revenue from sales of OCS Lung disposable sets outside the United States increased by $0.1 million from the three months ended June 30, 2020 to the three months ended June 30, 2021. Net revenue from sales of OCS Heart disposable sets outside of the United States increased by $1.4 million from the three months ended June 30, 2020 to the three months ended June 30, 2021. 26 Cost of Revenue, Gross Profit and Gross Margin Cost of revenue increased by $1.1 million in the three months ended June 30, 2021 compared to the three months ended June 30, 2020. Gross profit increased by $3.7 million in the three months ended June 30, 2021 compared to the three months ended June 30, 2020. Gross margin was 68% and 56% for the three months ended June 30, 2021 and 2020, respectively. Gross margin increased primarily as a result of higher margin OCS disposable sets sold and improvements in the efficiency of the production process. Operating Expenses Research, Development and Clinical Trials Expenses Three Months Ended June 30, 2021 2020 Change (in thousands) Personnel related (including stock-based compensation expense) $ 2,086 $ 2,036 $ 50 Clinical trials costs 1,071 728 343 Consulting and third-party testing 1,059 259 800 Laboratory supplies and research materials 1,088 221 867 Other 991 659 332 Total research, development and clinical trials expenses $ 6,295 $ 3,903 $ 2,392 Total research, development and clinical trials expenses increased by $2.4 million from $3.9 million in the three months ended June 30, 2020 to $6.3 million in the three months ended June 30, 2021 . Clinical trial costs increased by $0.3 million due to an increase in ongoing trial enrollment activity primarily related to the OCS Heart DCD CAP Trial. Consulting and third-party testing increased by $0.8 million due to increased regulatory activity, including costs related to preparation for both the OCS Heart FDA advisory committee panel in April and the OCS Liver FDA advisory committee panel in July. The increase in laboratory supplies and research materials costs of $0.9 million and other costs of $0.3 million is due primarily to increased research activities, product development and other activities as restrictions implemented in response to the COVID-19 pandemic were eased. Selling, General and Administrative Expenses Three Months Ended June 30, 2021 2020 Change (in thousands) Personnel related (including stock-based compensation expense) $ 4,934 $ 3,057 $ 1,877 Professional and consultant fees 1,868 1,586 282 Tradeshows and conferences 617 — 617 Other 1,743 1,224 519 Total selling, general and administrative expenses $ 9,162 $ 5,867 $ 3,295 Total selling, general and administrative expenses increased by $3.3 million from $5.9 million in the three months ended June 30, 2020 to $9.2 million in the three months ended June 30, 2021 due to an increase in personnel related costs, professional and consultant fees, tradeshows and conferences and other costs. Personnel related costs increased primarily due to the continued expansion of our commercial team to support commercial sales of our OCS Lung product in the United States. Stock-based compensation expense also increased by $1.0 million due primarily to additional grants to new and existing employees and an increase in the respective grant date fair values due to the increased market price of our stock. The increase in professional and consultant fees, trade shows and conferences and other costs is a result of an increase in activities as restrictions implemented in response to the COVID-19 pandemic were eased. Other Income (Expense) Interest Expense Interest expense was $1.0 million for each of the three months ended June 30, 2021 and 2020. 27 Other Income (Expense), Net Other income (expense), net for the three months ended June 30, 2021 and 2020 included interest income of less than $0.1 million and $0.2 million, respectively, resulting from interest earned on invested cash balances, and $0.1 million and $0.2 million of realized and unrealized foreign currency transaction gains, respectively. Comparison of the Six Months Ended June 30, 2021 and 2020 The following table summarizes our results of operations for the six months ended June 30, 2021 and 2020: Six Months Ended June 30, 2021 2020 Change (in thousands) Net revenue $ 15,224 $ 10,921 $ 4,303 Cost of revenue 4,824 4,152 672 Gross profit 10,400 6,769 3,631 Operating expenses: Research, development and clinical trials 10,827 10,128 699 Selling, general and administrative 15,948 12,519 3,429 Total operating expenses 26,775 22,647 4,128 Loss from operations (16,375 ) (15,878 ) (497 ) Other income (expense): Interest expense (1,917 ) (2,043 ) 126 Other income (expense), net (283 ) 588 (871 ) Total other expense, net (2,200 ) (1,455 ) (745 ) Loss before income taxes (18,575 ) (17,333 ) (1,242 ) Provision for income taxes (10 ) (16 ) 6 Net loss $ (18,585 ) $ (17,349 ) $ (1,236 ) Net Revenue Six Months Ended June 30, 2021 2020 Change (in thousands) Net revenue by geography: United States $ 11,515 $ 7,648 $ 3,867 Outside the U.S. 3,709 3,273 436 Total net revenue $ 15,224 $ 10,921 $ 4,303 Net revenue by OCS product: OCS Lung net revenue $ 6,002 $ 2,443 $ 3,559 OCS Heart net revenue 8,780 6,351 2,429 OCS Liver net revenue 442 2,127 (1,685 ) Total net revenue $ 15,224 $ 10,921 $ 4,303 Net revenue from customers in the United States was $11.5 million in the six months ended June 30, 2021 and increased by $3.9 million compared to the six months ended June 30, 2020, primarily due to higher sales volumes of our OCS Lung and OCS Heart disposable sets. Net revenue from sales of OCS Lung disposable sets in the United States increased from $2.3 million in the six months ended June 30, 2020 to $5.8 million in the six months ended June 30, 2021. The increase was due primarily to higher sales volume of OCS Lung disposable sets. Net revenue from OCS Heart disposable sets sold to customers for use in our ongoing clinical trials in the United States increased by $2.1 million, while net revenue from OCS Liver disposable sets sold in the United States decreased by $1.7 million. The increase in net revenue from OCS Heart disposable sets is attributed to higher volume of OCS Heart disposable sets sold in the OCS Heart DCD CAP Trial. The lower sales volume of OCS Liver disposable sets was primarily a result of the completion of enrollment of approved patients in our OCS Liver Protect CAP Trial early in the first quarter of 2021. Net revenue from customers outside the United States was $3.7 million in the six months ended June 30, 2021 compared to $3.3 million in the six months ended June 30, 2020. The increase in net revenue from customers outside the United States was primarily due to higher sales volumes of OCS Lung and OCS Heart disposable sets. Net revenue from sales of OCS Lung disposable sets outside the United States increased by $0.1 million and net revenue from OCS Heart disposable sets increased by $0.3 million from the six months ended June 30, 2020 to the six months ended June 30, 2021. 28 Cost of Revenue, Gross Profit and Gross Margin Cost of revenue increased by $0.7 million in the six months ended June 30, 2021 compared to the six months ended June 30, 2020. Gross profit increased by $3.6 million in the six months ended June 30, 2021 compared to the six months ended June 30, 2020. Gross margin was 68% and 62% for the six months ended June 30, 2021 and 2020, respectively. Gross margin increased primarily as a result of increased activity, higher margin OCS disposable sets sold and improvements in the efficiency of the production process. Operating Expenses Research, Development and Clinical Trials Expenses Six Months Ended June 30, 2021 2020 Change (in thousands) Personnel related (including stock-based compensation expense) $ 4,216 $ 4,184 $ 32 Clinical trials costs 2,048 2,714 (666 ) Consulting and third-party testing 1,371 938 433 Laboratory supplies and research materials 1,498 845 653 Other 1,694 1,447 247 Total research, development and clinical trials expenses $ 10,827 $ 10,128 $ 699 Total research, development and clinical trials expenses increased by $0.7 million from $10.1 million in the six months ended June 30, 2020 to $10.8 million in the six months ended June 30, 2021. Clinical trial costs decreased by $0.7 million due to a reduction in ongoing trial enrollment activity primarily related to the OCS Heart DCD CAP Trial and completion of our OCS Liver Protect Trial. Consulting and third-party testing costs increased by $0.4 million due primarily to increased regulatory activity, including costs related to preparation for both the OCS Heart FDA advisory committee panel in April and the OCS Liver FDA advisory committee panel in July. The increase in laboratory supplies and research materials costs of $0.7 million is due primarily to increased research activities, product development and other activities as restrictions implemented in response to the COVID-19 pandemic were eased. Selling, General and Administrative Expenses Six Months Ended June 30, 2021 2020 Change (in thousands) Personnel related (including stock-based compensation expense) $ 8,772 $ 6,129 $ 2,643 Professional and consultant fees 3,270 3,198 72 Tradeshows and conferences 805 487 318 Other 3,101 2,705 396 Total selling, general and administrative expenses $ 15,948 $ 12,519 $ 3,429 Total selling, general and administrative expenses increased by $3.4 million from $12.5 million in the six months ended June 30, 2020 to $15.9 million in the six months ended June 30, 2021 due to increases in personnel related costs, tradeshows and conferences and other expenses. Personnel related costs increased from the continued expansion of our commercial team to support commercial sales of our OCS Lung product in the United States. Stock-based compensation expense also increased by $1.6 million due primarily to additional grants to new and existing employees and an increase in the respective grant date fair values from the increased price of our stock. The increase in tradeshows and conferences and other expenses was due to a gradual return to normal activity as restrictions implemented in response to the COVID-19 pandemic were eased, which resulted in higher activity levels for the six months ended June 30, 2021 as compared to the six months ended June 30, 2020 and a resulting increase in related expenses. Other Income (Expense) Interest Expense Interest expense was $1.9 million and $2.0 million for the six months ended June 30, 2021 and 2020, respectively. 29 Other Income (Expense), Net Other income (expense), net for the six months ended June 30, 2021 and 2020 included interest income of $0.1 million and $0.5 million, respectively, resulting from interest earned on invested cash balances, and $0.4 million of realized and unrealized foreign currency transaction losses and $0.1 million of realized and unrealized foreign currency transaction gains, respectively. Liquidity and Capital Resources Since our inception, we have incurred significant operating losses. To date, we have funded our operations primarily with proceeds from sales of preferred stock and borrowings under loan agreements, proceeds from the sale of common stock in our public offerings and revenue from clinical trials and commercial sales of our OCS products. Since May 2019, we have funded our operations with the proceeds from our 2019 initial public offering of our common stock and our 2020 follow-on public offering. The follow-on public offering was completed on May 26, 2020 and resulted in net proceeds of $75.1 million. As of June 30, 2021, we had cash, cash equivalents, and marketable securities of $112.2 million. Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Six Months Ended June 30, 2021 2020 (in thousands) Cash used in operating activities $ (12,866 ) $ (16,715 ) Cash provided by (used in) investing activities 13,076 (28,009 ) Cash provided by financing activities 796 75,695 Effect of exchange rate changes on cash, cash equivalents and restricted cash (273 ) 89 Net increase in cash, cash equivalents and restricted cash $ 733 $ 31,060 Operating Activities During the six months ended June 30, 2021, operating activities used $12.9 million of cash, primarily resulting from our net loss of $18.6 million, partially offset by net cash provided by changes in our operating assets and liabilities of $0.6 million and net non-cash charges of $5.2 million. Net cash provided by changes in our operating assets and liabilities for the six months ended June 30, 2021 consisted primarily of a decrease in accounts receivable of $0.6 million and an increase in accounts payable and accrued expenses and other current liabilities of $2.9 million, partially offset by a $1.9 million increase in inventory and a $1.2 million increase in prepaid expenses and other current assets . During the six months ended June 30, 2020, operating activities used $16.7 million of cash, primarily resulting from our net loss of $17.3 million and net cash used by changes in our operating assets and liabilities of $1.3 million, partially offset by net non-cash charges of $1.9 million. Net cash used by changes in our operating assets and liabilities for the six months ended June 30, 2020 consisted primarily of a $3.2 million decrease in accounts payable and accrued expenses and other current liabilities, a $1.4 million increase in inventory and a $0.3 million increase in prepaid expenses and other current assets, partially offset by a $2.1 million decrease in accounts receivable, a $0.8 million increase in deferred revenue and a $0.6 million increase in deferred rent. Changes in accounts receivable, inventory, 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. Investing Activities During the six months ended June 30, 2021, net cash provided by investing activities of $13.1 million consisted of proceeds from sales and maturities of marketable securities of $58.8 million, partially offset by purchases of marketable securities of $45.5 million and purchases of property and equipment of $0.3 million. 30 During the six months ended June 30, 2020, net cash used in investing activities of $28.0 million consisted of $63.6 million in purchases of marketable securities and $0.4 million in purchases of property and equipment, partially offset by proceeds from sales and maturities of marketable securities of $36.0 million. Financing Activities During the six months ended June 30, 2021, net cash provided by financing activities of $0.8 million consisted of proceeds from the issuance of common stock in connection with the employee stock purchase plan of $0.2 million and proceeds from the issuance of common stock upon exercise of stock options of $0.6 million. During the six months ended June 30, 2020, net cash provided by financing activities of $75.7 million consisted primarily of proceeds from the issuance of common stock in our public offering and employee share ownership plans of $76.0 million, partially offset by payments of offering costs of $0.3 million. We also received proceeds from the Paycheck Protection Loan of $2.2 million, which we then fully repaid in the same period. Long-Term Debt We have a Credit Agreement with OrbiMed, pursuant to which we borrowed $35.0 million. Borrowings under the Credit Agreement bear interest at an annual rate equal to the LIBOR subject to a minimum of 1.0% and a maximum of 4.0%, plus 8.5%, or the Applicable Margin, subject in the aggregate to a maximum interest rate of 11.5%. In addition, borrowings under the Credit Agreement bear paid-in-kind, or PIK interest, at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeds 11.5%, but not to exceed 12.5%. The PIK interest is added to the principal amount of the borrowings outstanding at the end of each quarter until the maturity date of the Credit Agreement in June 2023. Borrowings under the Credit Agreement are repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest is due and payable. At our option, we may prepay outstanding borrowings under the Credit Agreement, subject to a prepayment premium that decreased to zero in June 2021. Our current prepayment premium is zero. We are also required to make a final payment in an amount equal to 3.0% of the principal amount of any prepayment or repayment, which we are accreting to interest expense over the term of the Credit Agreement using the effective interest method. All obligations under the 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, including a perfected security interest in substantially all tangible and intangible assets of us and each guarantor. Under the Credit Agreement, we have agreed to certain affirmative and negative covenants to which we will remain subject until maturity. The financial covenants include maintaining a minimum liquidity amount of $3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from our independent registered public accounting firm; and restrictions on our activities, including limitations on dispositions, mergers or acquisitions; encumbering our intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. The obligations under the 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, including the minimum liquidity and unqualified audit opinion covenants, and a material adverse change in our business, operations or other financial condition. As of June 30, 2021, we were in compliance with all of the covenants under the Credit Agreement. Upon the occurrence of an event of default and until such event of default is no longer continuing, the Applicable Margin will increase by 4.0% per annum. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, OrbiMed 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. While we do not expect that the transition from LIBOR, including any legal or regulatory changes made in response to its future phase out, or the risks related to its discontinuance will have a material effect on our financing costs, the impact is uncertain at this time. 31 Funding Requirements 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 sales and clinical adoption team, scale our manufacturing operation, continue research, development and clinical trial efforts, and seek regulatory approval for new products and product enhancements, including new indications, both in the United States and in select non-U.S. markets. In addition, following the closing of our IPO, we have incurred and expect to continue to incur additional costs associated with operating as a public company. The timing and amount of our operating and capital expenditures will depend on many factors, including: • the amount of net revenue generated by sales of our OCS Consoles, OCS disposable sets and other products that may be approved in the United States and select non-U.S. markets; • the costs and expenses of expanding our U.S. and non-U.S. sales and marketing infrastructure and our manufacturing operations; • the extent to which our OCS products are adopted by the transplant community; • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products; • the degree of success we experience in commercializing our OCS products for additional indications; • the costs, timing and outcomes of any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products; • the emergence of competing or complementary technologies; • the number and types of future products we develop and commercialize; • 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, cash equivalents, and marketable securities will enable us to fund our operating expenses, capital expenditure requirements, and debt service payments for at least 12 months following the filing of this Quarterly Report on Form 10-Q. 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 our 2020 Form 10-K. Contractual Obligations and Commitments There have been no material changes to our contractual obligations and commitments from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2020 Form 10-K. Inflation Risk We do not believe that inflation has had a material effect on our business, financial condition or results of operations. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition or results of operations. Critical Accounting Policies and Significant Judgments and Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. We evaluate our estimates on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. There have been no material changes to our critical accounting policies and estimates from those disclosed in our consolidated financial statements and the related notes and other financial information included in our 2020 Form 10-K. 32 Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC. Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. Emerging Growth Company Status The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. As of June 30, 2021, the market value of our common stock held by non-affiliates exceeded $700 million. As a result, we will no longer be an emerging growth company as of December 31, 2021 and will be a large accelerated filer beginning January 1, 2022.