TransMedics Group, Inc. 10-Q

Item 1. Financial Statements (Unaudited) TRANSMEDICS GROUP, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share amounts) (Unaudited) September 30, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 204,462 $ 25,580 Marketable securities — 66,872 Accounts receivable 22,035 5,934 Inventory 18,575 14,859 Prepaid expenses and other current assets 5,514 5,460 Total current assets 250,586 118,705 Property and equipment, net 18,472 9,841 Restricted cash 500 500 Operating lease right-of-use assets 5,315 5,847 Total assets $ 274,873 $ 134,893 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 3,080 $ 6,651 Accrued expenses and other current liabilities 15,976 16,337 Deferred revenue 226 250 Operating lease liabilities 1,407 — Total current liabilities 20,689 23,238 Long-term debt, net of discount and current portion 58,540 35,197 Operating lease liabilities, net of current portion 7,787 8,604 Total liabilities 87,016 67,039 Commitments and contingencies (Note 9) Stockholders' equity: Preferred stock, no par value; 25,000,000 shares authorized; no shares issued or outstanding — — Common stock, no par value; 150,000,000 shares authorized; 31,933,984 shares and 27,791,615 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively 660,061 510,488 Accumulated other comprehensive loss ( 247 ) ( 188 ) Accumulated deficit ( 471,957 ) ( 442,446 ) Total stockholders' equity 187,857 67,854 Total liabilities and stockholders' equity $ 274,873 $ 134,893 The accompanying notes are an integral part of these consolidated financial statements. 1 TRANSMEDICS GROUP, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share amounts) (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net revenue $ 25,683 $ 5,370 $ 62,084 $ 20,594 Cost of revenue 7,568 1,597 17,515 6,421 Gross profit 18,115 3,773 44,569 14,173 Operating expenses: Research, development and clinical trials 6,808 5,163 21,056 15,990 Selling, general and administrative 16,851 10,335 48,171 26,283 Total operating expenses 23,659 15,498 69,227 42,273 Loss from operations ( 5,544 ) ( 11,725 ) ( 24,658 ) ( 28,100 ) Other income (expense): Interest expense ( 787 ) ( 979 ) ( 2,719 ) ( 2,896 ) Other expense, net ( 1,076 ) ( 249 ) ( 2,087 ) ( 532 ) Total other expense, net ( 1,863 ) ( 1,228 ) ( 4,806 ) ( 3,428 ) Loss before income taxes ( 7,407 ) ( 12,953 ) ( 29,464 ) ( 31,528 ) Provision for income taxes ( 19 ) ( 9 ) ( 47 ) ( 19 ) Net loss $ ( 7,426 ) $ ( 12,962 ) $ ( 29,511 ) $ ( 31,547 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 0.25 ) $ ( 0.47 ) $ ( 1.03 ) $ ( 1.14 ) Weighted average common shares outstanding, basic and diluted 30,229,936 27,701,252 28,729,649 27,564,589 The accompanying notes are an integral part of these consolidated financial statements. 2 TRANSMEDICS GROUP, INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In thousands) (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ ( 7,426 ) $ ( 12,962 ) $ ( 29,511 ) $ ( 31,547 ) Other comprehensive income (loss): Foreign currency translation adjustment ( 41 ) 3 ( 95 ) ( 26 ) Unrealized gains (losses) on marketable securities, net of tax of $ 0 100 — 36 ( 10 ) Total other comprehensive income (loss) 59 3 ( 59 ) ( 36 ) Comprehensive loss $ ( 7,367 ) $ ( 12,959 ) $ ( 29,570 ) $ ( 31,583 ) The accompanying notes are an integral part of these consolidated financial statements. 3 TRANSMEDICS GROUP, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (in thousands, except share amounts) (Unaudited) Accumulated Other Total Common Stock Comprehen- Accumulated Stockholders' Shares Amount sive Loss Deficit Equity Balances at December 31, 2021 27,791,615 $ 510,488 $ ( 188 ) $ ( 442,446 ) $ 67,854 Issuance of common stock upon the exercise of common stock options 164,503 202 — — 202 Issuance of common stock in connection with employee stock purchase plan 12,465 203 — — 203 Stock-based compensation expense — 2,310 — — 2,310 Foreign currency translation adjustment — — ( 24 ) — ( 24 ) Unrealized losses on marketable securities — — ( 73 ) — ( 73 ) Net loss — — — ( 10,562 ) ( 10,562 ) Balances at March 31, 2022 27,968,583 513,203 ( 285 ) ( 453,008 ) 59,910 Issuance of common stock upon the exercise of common stock options 31,592 237 — — 237 Stock-based compensation expense — 2,316 — — 2,316 Issuance of restricted common stock 23,120 — — — — Foreign currency translation adjustment — — ( 30 ) — ( 30 ) Unrealized gains on marketable securities — — 9 — 9 Net loss — — — ( 11,523 ) ( 11,523 ) Balances at June 30, 2022 28,023,295 515,756 ( 306 ) ( 464,531 ) 50,919 Issuance of common stock in public offering, net of discounts and issuance costs of $ 676 3,737,500 139,854 — — 139,854 Issuance of common stock upon the exercise of common stock options 154,316 1,441 — — 1,441 Issuance of common stock in connection with employee stock purchase plan 17,678 306 — — 306 Issuance of restricted common stock 2,973 — — — — Restricted common stock forfeitures ( 1,778 ) — — — — Stock-based compensation expense — 2,704 — — 2,704 Foreign currency translation adjustment — — ( 41 ) — ( 41 ) Unrealized gains on marketable securities — — 100 — 100 Net loss — — — ( 7,426 ) ( 7,426 ) Balances at September 30, 2022 31,933,984 $ 660,061 $ ( 247 ) $ ( 471,957 ) $ 187,857 The accompanying notes are an integral part of these consolidated financial statements. 4 TRANSMEDICS GROUP, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (in thousands, except share amounts) (Unaudited) Accumulated Other Total Common Stock Comprehen- Accumulated Stockholders' Shares Amount sive Loss Deficit Equity Balances at December 31, 2020 27,175,305 $ 502,217 $ ( 95 ) $ ( 398,231 ) $ 103,891 Issuance of common stock upon the exercise of common stock options 287,705 372 — — 372 Issuance of common stock in connection with employee stock purchase plan 14,951 211 — — 211 Stock-based compensation expense — 1,112 — — 1,112 Foreign currency translation adjustment — — ( 2 ) — ( 2 ) Unrealized gains on marketable securities — — 8 — 8 Net loss — — — ( 7,917 ) ( 7,917 ) Balances at March 31, 2021 27,477,961 503,912 ( 89 ) ( 406,148 ) 97,675 Issuance of common stock upon the exercise of common stock options 169,273 213 — — 213 Stock-based compensation expense — 1,808 — — 1,808 Foreign currency translation adjustment — — ( 27 ) — ( 27 ) Unrealized losses on marketable securities — — ( 18 ) — ( 18 ) Net loss — — — ( 10,668 ) ( 10,668 ) Balances at June 30, 2021 27,647,234 505,933 ( 134 ) ( 416,816 ) 88,983 Issuance of common stock upon the exercise of common stock options 104,753 344 — — 344 Issuance of common stock in connection with employee stock purchase plan 12,898 208 — — 208 Stock-based compensation expense — 1,973 — — 1,973 Foreign currency translation adjustment — — 3 — 3 Net loss — — — ( 12,962 ) ( 12,962 ) Balances at September 30, 2021 27,764,885 $ 508,458 $ ( 131 ) $ ( 429,778 ) $ 78,549 The accompanying notes are an integral part of these consolidated financial statements. 5 TRANSMEDICS GROUP, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (Unaudited) Nine Months Ended September 30, 2022 2021 Cash flows from operating activities: Net loss $ ( 29,511 ) $ ( 31,547 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization expense 2,193 1,351 Stock-based compensation expense 7,330 4,893 Loss on extinguishment of debt 575 — Loss on sale of marketable securities 107 — Non-cash interest expense and end of term accretion expense 309 401 Non-cash lease expense 532 — Net amortization of premiums on marketable securities 381 1,075 Unrealized foreign currency transaction losses 1,733 587 Changes in operating assets and liabilities: Accounts receivable ( 16,287 ) 2,650 Inventory ( 6,094 ) ( 3,964 ) Prepaid expenses and other current assets ( 98 ) ( 1,392 ) Accounts payable ( 3,534 ) 1,226 Accrued expenses and other current liabilities ( 8 ) 2,356 Deferred revenue — 72 Operating lease liabilities 590 — Deferred rent — 76 Net cash used in operating activities ( 41,782 ) ( 22,216 ) Cash flows from investing activities: Purchases of property and equipment ( 9,143 ) ( 341 ) Purchases of marketable securities ( 10,496 ) ( 66,694 ) Proceeds from sales and maturities of marketable securities 76,916 86,310 Net cash provided by investing activities 57,277 19,275 Cash flows from financing activities: Proceeds from issuance of long-term debt, net of issuance costs 58,509 — Repayments of long-term debt ( 36,050 ) — Proceeds from issuance of common stock in public offering, net of underwriting discounts and commissions and issuance costs paid 140,014 — Proceeds from issuance of common stock upon exercise of stock options 1,880 929 Proceeds from issuance of common stock in connection with employee stock purchase plan 509 419 Net cash provided by financing activities 164,862 1,348 Effect of exchange rate changes on cash, cash equivalents and restricted cash ( 1,475 ) ( 493 ) Net increase (decrease) in cash, cash equivalents and restricted cash 178,882 ( 2,086 ) Cash, cash equivalents and restricted cash, beginning of period 26,080 25,081 Cash, cash equivalents and restricted cash, end of period $ 204,962 $ 22,995 Supplemental disclosure of non-cash investing activities: Transfers of inventory to property and equipment $ 2,055 $ 935 Purchases of property and equipment included in accounts payable and accrued expenses $ 926 $ 342 Offering costs included in accounts payable and accrued expenses $ 160 $ — Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalents $ 204,462 $ 22,495 Restricted cash 500 500 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 204,962 $ 22,995 The accompanying notes are an integral part of these consolidated financial statements. 6 TRANSMEDICS GROUP, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) 1. Nature of the Business and Basis of Presentation TransMedics Group, Inc. (“TransMedics Group” and, together with its consolidated subsidiaries, the “Company”) was incorporated in the Commonwealth of Massachusetts in October 2018. TransMedics, Inc. (“TransMedics”), an operating company and wholly owned subsidiary of TransMedics Group, was incorporated in the State of Delaware in August 1998. The Company is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. The Company developed the Organ Care System (“OCS”) to replace a decades-old standard of care. 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. The Company’s OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including net losses of $ 29.5 million for the nine months ended September 30, 2022 and $ 44.2 million for the year ended December 31, 2021. As of September 30, 2022, the Company had an accumulated deficit of $ 472.0 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company believes that its existing cash and cash equivalents of $ 204.5 million as of September 30, 2022 will be sufficient to fund its operations, capital expenditures, and debt service payments for at least the next 12 months following the filing of this Quarterly Report on Form 10-Q. The Company may need to seek additional funding through equity financings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations. The Company is subject to risks and uncertainties common to companies in the medical device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. Products currently under development will require additional research and development efforts, including additional clinical testing and regulatory approval, prior to commercialization. These efforts require additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, the Company may not obtain necessary government regulatory approval on its expected timeline or at all, and approved products may not prove commercially viable. The Company operates in an environment of rapid change in technology and competition. The impact of the COVID-19 pandemic has been and may continue to be extensive in many aspects of society, which has resulted in and may continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Continued impacts to the Company’s business as a result of COVID-19 may include disruptions to the Company’s manufacturing operations and supply chain; labor shortages; decreased productivity and unavailability of materials or components; limitations on its employees’ and customers’ ability to travel, and delays in product installations, trainings or shipments to and from other affected countries and within the United States. While the Company maintains an inventory of finished products and raw materials used in its OCS products, prolonged pandemic-related disruptions could lead to shortages in the raw materials necessary to manufacture its products. 7 The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2022 and results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, revenue recognition, the valuation of inventory and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. Risk of Concentrations of Credit, Significant Customers and Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of September 30, 2022 and December 31, 2021, the Company had no allowance for credit losses. Significant customers are those that accounted for 10 % or more of the Company’s net revenue or accounts receivable. For the three months ended September 30, 2022, one customer accounted for 13 % of net revenue. For the nine months ended September 30, 2022, one customer accounted for 15 % of net revenue. For the three months ended September 30, 2021, two customers accounted for 16 % and 12 % of net revenue, respectively. For the nine months ended September 30, 2021, one customer accounted for 10 % of net revenue. As of September 30, 2022, there were no customers that accounted for more than 10 % of accounts receivable. As of December 31, 2021, two customers accounted for 21 % and 15 % of accounts receivable, respectively. Certain of the components and subassemblies included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers. Although the Company seeks to reduce dependence on those limited sources of suppliers and manufacturers, the partial or complete loss of certain of these sources could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships. 8 Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company has developed and is commercializing a proprietary system to preserve human organs for transplant in a near-physiologic condition to address the limitations of cold storage organ preservation. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance. Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock awards. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three and nine months ended September 30, 2022 and 2021. The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: As of September 30, 2022 2021 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 3,309,558 2,757,648 Employee stock purchase plan 8,886 3,956 Restricted stock awards 24,315 — 3,407,199 2,826,044 9 3. Marketable Securities The Company did no t have marketable securities as of September 30, 2022. Marketable securities by security type as of December 31, 2021 consisted of the following (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Credit Losses Fair Value U.S. Treasury securities (due within one year) $ 63,907 $ — $ ( 33 ) $ — $ 63,874 U.S. government agency bonds (due within one year) 3,001 — ( 3 ) — 2,998 $ 66,908 $ — $ ( 36 ) $ — $ 66,872 4. Fair Value of Financial Assets and Liabilities The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands): Fair Value Measurements at September 30, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 182,091 $ — $ — $ 182,091 $ 182,091 $ — $ — $ 182,091 Fair Value Measurements at December 31, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 11,169 $ — $ — $ 11,169 Marketable securities: U.S. Treasury securities — 63,874 — 63,874 U.S. government agency bonds — 2,998 — 2,998 $ 11,169 $ 66,872 $ — $ 78,041 Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. U.S. Treasury securities and U.S. government agency bonds were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. 10 5. Inventory Inventory consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 9,439 $ 7,274 Work-in-process 1,721 1,932 Finished goods 7,415 5,653 $ 18,575 $ 14,859 During the nine months ended September 30, 2022 and 2021, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $ 2.1 million and $ 0.9 million, respectively. 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2022 December 31, 2021 Accrued research, development and clinical trials expenses $ 2,735 $ 4,567 Accrued payroll and related expenses 6,064 5,173 Accrued professional fees 1,424 1,973 Accrued other 5,753 4,624 $ 15,976 $ 16,337 7. Long-Term Debt Long-term debt consisted of the following (in thousands): September 30, 2022 December 31, 2021 Principal amount of long-term debt $ 60,000 $ 35,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 60,000 35,000 Debt discount, net of accretion ( 1,460 ) ( 511 ) Accrued end-of-term payment — 708 Long-term debt, net of discount and current portion $ 58,540 $ 35,197 OrbiMed Credit Agreement The Company entered into a credit agreement with OrbiMed Royalty Opportunities II, LP (the “OrbiMed Credit Agreement”) in June 2018, pursuant to which TransMedics borrowed $ 35.0 million. Borrowings under the OrbiMed Credit Agreement bore interest at an annual rate equal to the London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0 % and a maximum of 4.0 % , plus 8.5 % (the “Applicable Margin”), subject in the aggregate to a maximum interest rate of 11.5 %. In addition, borrowings under the OrbiMed Credit Agreement bore paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeded 11.5 %, but not to exceed 12.5 %. The PIK interest was added to the principal amount of the borrowings outstanding at the end of each quarter until the repayment of the borrowings in July 2022 . Borrowings under the OrbiMed Credit Agreement were repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest was due and payable. At its option, the company could prepay outstanding borrowings under the OrbiMed Credit Agreement. The Company was required to make a final payment in an amount equal to 3.0 % of the principal amount of any prepayment or repayment. The final payment and debt discount amounts were being accreted to interest expense over the term of the OrbiMed Credit Agreement using the effective interest method. In July 2022, the Company repaid amounts due under the OrbiMed Credit Agreement, including $ 35.0 million of principal repayments and a $ 1.1 million end of term payment, as well as accrued interest and the OrbiMed Credit Agreement 11 was terminated. Upon repayment of the outstanding amounts, the Company recorded a loss on extinguishment of debt of $ 0.6 million, which was classified as other expense in the consolidated statemen t s of operations. Canadian Imperial Bank of Commerce Credit Agreement In July 2022, the Company entered into a credit agreement with Canadian Imperial Bank of Commerce (“CIBC”), pursuant to which the Company borrowed $ 60.0 million (the “CIBC Credit Agreement”). Borrowings under the CIBC Credit Agreement bear interest at an annual rate equal to either, at the Company’s option, (i) the secured overnight financing rate for an interest period selected by the Company, subject to a minimum of 1.5 %, 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 %. Borrowings under the CIBC Credit Agreement are payable in monthly interest-only payments for the first 24 months, and then payable in equal monthly principal payments plus accrued interest until the maturity date of the CIBC Credit Agreement in July 2027 . If certain revenue milestones are met after the first 24 months, the Company may extend the interest-only repayment period by one additional year. At the Company’s option, the Company may prepay borrowings outstanding under the CIBC Credit Agreement, subject to a prepayment fee of 2.0 % of outstanding borrowings if paid prior to 12 months after the closing date, and 1.0 % if paid on or after 12 months after the closing date but prior to 24 months after the closing date. In connection with entering into the CIBC Credit Agreement, the Company paid upfront fees and other costs of $ 1.5 million, which were recorded by the Company as a debt discount. The debt discount is reflected as a reduction of the carrying value of long-term debt on the Company’s consolidated balance sheet and is being accreted to interest expense over the term of the CIBC Credit Agreement using the effective interest method. All obligations under the CIBC Credit Agreement are guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor are secured by substantially all of the Company’s and each guarantor’s assets, including their intellectual property, subject to certain exceptions. Under the CIBC Credit Agreement, the Company has agreed to customary representations and warranties, events of default and certain affirmative and negative covenants to which it 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) 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 the Company’s business), failure to comply with certain covenants and a material adverse change in the Company’s business, operations or financial condition. As of September 30, 2022, the Company was 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, the Company 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. The Company assessed all terms and features of the CIBC Credit Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the debt. The Company determined that all features of the CIBC Credit Agreement are either clearly and closely associated with a debt host or have a de minimis fair value and, as such, do not require separate accounting as a derivative liability. As of September 30, 2022, the interest rate applicable to borrowings under the CIBC Credit Agreement was 4.5 %. During the three months ended September 30, 2022, the weighted average effective interest rate on outstanding borrowings under the CIBC Credit Agreement was approximately 5.2 %. 12 8. Stock-Based Compensation 2019 Stock Incentive Plan The Company’s 2019 Stock Incentive Plan (the “2019 Plan”) provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, unrestricted stock units, and other stock-based awards to employees, directors, and consultants of the Company and its subsidiaries. The number of shares of common stock of TransMedics Group initially available for issuance under the 2019 Plan was 3,428,571 shares, plus the number of shares underlying awards under the previously outstanding 2014 Stock Incentive Plan (the “2014 Plan”), not to exceed 1,595,189 shares, that expire or are terminated, surrendered, or canceled without the delivery of shares, are forfeited to or repurchased by TransMedics Group or otherwise become available again for grant. Since the effectiveness of the Company’s 2019 Plan in April 2019, no future awards will be made under the 2014 Plan. Shares withheld in payment of the exercise or purchase price of an award or in satisfaction of tax withholding requirements, and the shares covered by a stock appreciation right for which any portion is settled in stock, will reduce the number of shares available for issuance under the 2019 Plan. In addition, the number of shares available for issuance under the 2019 Plan (i) will not be increased by any shares delivered under the 2019 Plan that are subsequently repurchased using proceeds directly attributable to stock option exercises and (ii) will not be reduced by any awards that are settled in cash or that expire, become unexercisable, terminate or are forfeited to or repurchased by TransMedics Group without the issuance of stock under the 2019 Plan. As of September 30, 2022, 819,791 shares of common stock were available for issuance under the 2019 Plan. 2019 Employee Stock Purchase Plan Pursuant to the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”), certain employees of the Company are eligible to purchase common stock of the Company at a reduced price during offering periods. The 2019 ESPP permits participants to purchase common stock using funds contributed through payroll deductions, subject to the limitations set forth in the Internal Revenue Code, at a purchase price of 85 % of the lower of the closing price of the Company’s common stock on the first trading day of the offering period or the closing price on the applicable purchase date, which is the final trading day of the applicable offering period. A total of 371,142 shares of the Company’s common stock are reserved for issuance under the 2019 ESPP. During the nine months ended September 30, 2022, 30,143 shares of common stock were issued under the 2019 ESPP and as of September 30, 2022, 290,453 shares of common stock remained available for issuance. 2021 Inducement Plan In August 2021, the Company’s board of directors approved the TransMedics Group, Inc. Inducement Plan (the “Inducement Plan”). Pursuant to the terms of the Inducement Plan, the Company may grant nonstatutory stock options, stock appreciation rights, restricted stock, unrestricted stock, restricted stock unit awards and performance awards to individuals who were not previously employees or directors of the Company or individuals returning to employment after a bona fide period of non-employment with the Company. A total of 1,000,000 shares of the Company’s common stock were initially available for issuance under the Inducement Plan. As of September 30, 2022, 616,100 shares of common stock remained available for issuance under the Inducement Plan. Stock Option Activity During the nine months ended September 30, 2022, the Company granted options under the 2019 Plan and the Inducement Plan to its employees and directors with service-based vesting for the purchase of an aggregate of 1,057,510 shares of common stock with a weighted average grant-date fair value of $ 8.91 per share. Restricted Common Stock Activity During the nine months ended September 30, 2022, the Company granted shares of restricted common stock. Shares of unvested restricted common stock may not be sold or transferred by the holder. If the holder’s service to the Company and its affiliates ceases for any reason, unvested shares of restricted common stock held by these individuals will immediately be forfeited for no consideration, as defined in the restricted stock agreement. During the nine months ended September 30, 2022, the Company granted 26,093 shares of restricted common stock under the 2019 Plan to consultants with service-based vesting conditions and a weighted-average grant-date fair value of $ 28.74 per share. 13 Stock-Based Compensation The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Cost of revenue $ 33 $ 20 $ 89 $ 52 Research, development and clinical trials expenses 394 312 1,079 829 Selling, general and administrative expenses 2,277 1,641 6,162 4,012 $ 2,704 $ 1,973 $ 7,330 $ 4,893 As of September 30, 2022, total unrecognized compensation cost related to unvested share-based awards was $ 21.1 million, which is expected to be recognized over a weighted average period of 2.6 years. 9. Commitments and Contingencies Operating Leases The Company leases office, laboratory and manufacturing space under two non-cancelable operating leases. There have been no material changes to the Company’s leases during the nine months ended September 30, 2022. For additional information, please read Note 12 Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2021. License Agreement with the Department of Veterans Affairs In 2002, the Company entered into a license agreement with the Department of Veterans Affairs (the “VA”), under which the Company was granted an exclusive, worldwide license under specified patents to make, use, sell and import certain technology used in the Company’s products and a non-exclusive, worldwide license to make, use, sell and import solutions for use in or with those products. The rights under the license agreement continued until the expiration of the last to expire of the licensed patents. The majority of the licensed U.S. patents expired in 2017, and the foreign patents expired in September 2018. However, the Company requested a patent term extension for one U.S. patent covered by the VA license agreement, U.S. Patent No. 6100082 (the “’082 patent”). The Company received a Notice of Final Determination on June 27, 2022 from the United States Patent and Trademark Office (“USPTO”) finding the ‘082 patent’s term extension expired on November 6, 2021, and as a result the license has terminated. The termination of the license is not expected to have a material impact on the Company’s financial results. As consideration for the licenses granted by the VA, the Company was obligated to pay tiered royalties ranging from a low single-digit to a mid single-digit percentage on net sales of each product covered by a licensed patent (subject to a minimum aggregate royalty payment of less than $ 0.1 million per year during each of the first five years after the first commercial sale, after which no minimum is required). Royalties were paid by the Company on a licensed product-by-licensed product and country-by-country basis, beginning on the first commercial sale of such licensed product in such country until expiration of the last valid patent claim covering such licensed product in such country. The Company was also responsible for all costs related to the amendment, prosecution and maintenance of the licensed patent rights. As all of the licensed patents expired as of November 6, 2021, the Company no longer has an obligation to pay royalties. 401(k) Savings Plan The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. As of September 30, 2022 and December 31, 2021, the Company had no t made any contributions to the plan. Indemnification Agreements In the ordinary course of business, the Company has agreed to defend and indemnify its customers against third-party claims asserting infringement of certain intellectual property rights, which may include patents, copyrights, trademarks, or trade secrets. The Company’s exposure under these indemnification provisions is generally limited to the total amount paid 14 by the end-customer under the agreement. However, certain agreements include indemnification provisions that could potentially expose the Company to losses in excess of the amount received under the agreement. In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and had not accrued any liabilities related to such obligations in its consolidated financial statements as of September 30, 2022 and December 31, 2021. Unconditional Purchase Commitment In January 2021, the Company entered into an unconditional $ 9.5 million purchase commitment, in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029 . The contract is not cancellable without penalty. The remaining purchase commitment as of September 30, 2022 was $ 8.0 million. Legal Proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. 10. Segment Reporting and Geographic Data The Company has determined that it operates in one segment (see Note 2). See Note 11 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands): September 30, 2022 December 31, 2021 Long-lived assets by country(1): United States $ 17,886 $ 9,085 All other countries 586 756 Total long-lived assets $ 18,472 $ 9,841 ( 1 ) The Company’s only long-lived assets consist of property and equipment, net of depreciation, which are categorized based on their location of domicile . 11. Revenue The Company has determined that the payments made to the customer for reimbursement of clinical trial materials and customer’s costs incurred to execute specific clinical trial protocols related to the Company’s OCS products do not provide the Company with a distinct good or service transferred by the customer, and therefore such payments are recorded as a reduction of revenue from the customer in the Company’s consolidated statements of operations. Reductions of revenue related to such payments made to customers for reimbursements are recognized when the Company recognizes the revenue for the sale of its OCS disposable sets. The reconciliation of gross revenue to net revenue for these certain payments is shown below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Gross revenue from sales to customers $ 24,303 $ 5,413 $ 60,704 $ 21,717 Less: clinical trial payments ( 1,380 ) 43 ( 1,380 ) 1,123 Total net revenue $ 25,683 $ 5,370 $ 62,084 $ 20,594 15 Clinical trial payments for the three and nine months ended September 30, 2022 include adjustments for certain clinical trial accrual estimates. As clinical trials reach the end of their follow up period, the Company updates its accrual estimates. The Company will continue to update its clinical trial accrual estimates as all information related to clinical trial payments is received. The Company determined that payments made to customers to obtain information related to post-approval studies or existing standard-of-care protocols (i.e., unrelated to the Company’s OCS products) meet the criteria to be classified as a cost because the Company receives a distinct good or service transferred by the customer separate from the customer’s purchase of the Company’s OCS products and the consideration paid to the customer represents the fair value of the distinct good or service received. As a result, such payments made to the customers are recorded as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $ 0.5 million and $ 1.0 million for the three and nine months ended September 30, 2022, respectively, as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $ 0.4 million and $ 1.6 million for the three and nine months ended September 30, 2021, respectively, as operating expenses. Disaggregated Revenue The Company disaggregates revenue from contracts with customers by product type and geographical area as it believes this presentation best depicts how the nature, amount, timing and uncertainty of the Company’s revenue and cash flows are affected by economic factors, as shown below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net revenue by OCS product: OCS Lung net revenue $ 1,599 $ 2,522 $ 6,736 $ 8,524 OCS Heart net revenue 11,541 2,848 25,318 11,628 OCS Liver net revenue 12,543 — 30,030 442 Total net revenue $ 25,683 $ 5,370 $ 62,084 $ 20,594 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net revenue by country(1): United States $ 23,285 $ 3,112 $ 54,984 $ 14,627 All other countries 2,398 2,258 7,100 5,967 Total net revenue $ 25,683 $ 5,370 $ 62,084 $ 20,594 (1) Net revenue by country is categorized based on the location of the end customer. When a customer order includes disposable sets and organ retrieval or OCS organ management services, the Company has determined that the disposable sets and services constitute separate performance obligations and recognizes revenue as the disposable sets and services are delivered to the customer. Net revenue during the three and nine months ended September 30, 2022 included service revenue comprising approximately 17 % and 13 %, respectively, of net revenue relating to organ retrieval and OCS organ management services sold under the National OCS Program, the Company’s turnkey solution to provide outsourced organ retrieval and OCS organ management. Contract Assets and Liabilities The Company recognizes a receivable at the point in time at which it has an unconditional right to payment. Such receivables are not contract assets. Contract assets arise from unbilled amounts in customer arrangements when revenue recognized exceeds the amount billed to the customer and the Company’s right to payment is not just subject to the passage of time. The Company had no contract assets as of September 30, 2022 and December 31, 2021. Contract liabilities represent the Company’s obligation to transfer goods or services to a customer for which it has received consideration (or the amount is due) from the customer. The Company has determined that its only contract liabilities are deferred revenue, which consists of amounts that have been invoiced but that have not been recognized as revenue. 16 The Company generally satisfies performance obligations within one year of the contract inception date. As of September 30, 2022, the Company’s wholly or partially unsatisfied performance obligations totaled $ 1.6 million and are expected to be completed within the next year. 12. Related Party Transactions Employment of Dr. Amira Hassanein Dr. Amira Hassanein, who serves as Product Director for the Company’s OCS Lung program, is the sister of Dr. Waleed Hassanein, the Company’s President and Chief Executive Officer and a member of the Company’s board of directors. The Company paid Dr. Amira Hassanein approximately $ 0.1 million and $ 0.3 million in total compensation for the three and nine months ended September 30, 2022, respectively, and $ 0.1 million and $ 0.3 million in total compensation for the three and nine months ended September 30, 2021, respectively, for her services as an employee. 17