Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | TransMedics Group, Inc. | |
Entity Central Index Key | 0001756262 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding | 32,553,650 | |
Entity File Number | 001-38891 | |
Entity Incorporation, State or Country Code | MA | |
Entity Tax Identification Number | 83-2181531 | |
Entity Address, Address Line One | 200 Minuteman Road | |
Entity Address, City or Town | Andover | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01810 | |
City Area Code | 978 | |
Local Phone Number | 552-0900 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, No Par Value | |
Trading Symbol | TMDX | |
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 195,375 | $ 201,182 |
Accounts receivable | 38,620 | 27,611 |
Inventory | 23,961 | 20,605 |
Prepaid expenses and other current assets | 3,774 | 2,896 |
Total current assets | 261,730 | 252,294 |
Property and equipment, net | 19,161 | 19,223 |
Restricted cash | 750 | 500 |
Operating lease right-of-use assets | 4,939 | 5,130 |
Other non-current assets | 508 | |
Total assets | 287,088 | 277,147 |
Current liabilities: | ||
Accounts payable | 4,329 | 3,341 |
Accrued expenses and other current liabilities | 22,581 | 18,635 |
Deferred revenue | 244 | 241 |
Operating lease liabilities | 1,481 | 1,444 |
Total current liabilities | 28,635 | 23,661 |
Long-term debt, net of discount and current portion | 58,802 | 58,696 |
Operating lease liabilities, net of current portion | 7,026 | 7,415 |
Total liabilities | 94,463 | 89,772 |
Commitments and contingencies (Note 8) | ||
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; 32,534,003 shares and 32,141,368 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 674,156 | 666,277 |
Accumulated other comprehensive loss | (218) | (225) |
Accumulated deficit | (481,313) | (478,677) |
Total stockholders' equity | 192,625 | 187,375 |
Total liabilities and stockholders' equity | $ 287,088 | $ 277,147 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement Of Financial Position [Abstract] | ||
Preferred Stock, No Par Value | ||
Preferred Stock, Shares Authorized | 25,000,000 | 25,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, No Par Value | ||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 32,534,003 | 32,141,368 |
Common Stock, Shares, Outstanding | 32,534,003 | 32,141,368 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Total revenue | $ 41,554 | $ 15,880 |
Cost of revenue: | ||
Total cost of revenue | 12,788 | 3,776 |
Gross profit | 28,766 | 12,104 |
Operating expenses: | ||
Research, development and clinical trials | 5,871 | 7,534 |
Selling, general and administrative | 24,984 | 13,939 |
Total operating expenses | 30,855 | 21,473 |
Loss from operations | (2,089) | (9,369) |
Other income (expense): | ||
Interest expense | (1,091) | (960) |
Other income (expense), net | 555 | (227) |
Total other expense, net | (536) | (1,187) |
Loss before income taxes | (2,625) | (10,556) |
Provision for income taxes | (11) | (6) |
Net loss | $ (2,636) | $ (10,562) |
Net loss per share attributable to common stockholders, basic | $ (0.08) | $ (0.38) |
Net loss per share attributable to common stockholders, diluted | $ (0.08) | $ (0.38) |
Weighted average common shares outstanding, basic | 32,260,267 | 27,950,330 |
Weighted average common shares outstanding, diluted | 32,260,267 | 27,950,330 |
Net product revenue [Member] | ||
Revenue: | ||
Total revenue | $ 33,993 | $ 14,939 |
Cost of revenue: | ||
Total cost of revenue | 7,306 | 3,378 |
Service Revenue [Member] | ||
Revenue: | ||
Total revenue | 7,561 | 941 |
Cost of revenue: | ||
Total cost of revenue | $ 5,482 | $ 398 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (2,636) | $ (10,562) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | 7 | (24) |
Unrealized losses on marketable securities, net of tax of $0 | (73) | |
Total other comprehensive income (loss) | 7 | (97) |
Comprehensive loss | $ (2,629) | $ (10,659) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Other Comprehensive Income (Loss), Securities, Available-for-Sale, Unrealized Holding Gain (Loss) Arising During Period, Tax | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 67,854 | $ 510,488 | $ (188) | $ (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 | |||
Issuance of common stock upon the exercise of common stock options | 202 | $ 202 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 164,503 | |||
Issuance of common stock in connection with employee stock purchase plan | 203 | $ 203 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 12,465 | |||
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) | ||
Balance at Mar. 31, 2022 | 59,910 | $ 513,203 | (285) | (453,008) |
Balance, Shares at Mar. 31, 2022 | 27,968,583 | |||
Balance at Dec. 31, 2021 | 67,854 | $ 510,488 | (188) | (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 | |||
Net loss | (36,200) | |||
Balance at Dec. 31, 2022 | 187,375 | $ 666,277 | (225) | (478,677) |
Balance, Shares at Dec. 31, 2022 | 32,141,368 | |||
Issuance of common stock upon the exercise of common stock options | 3,574 | $ 3,574 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 378,500 | |||
Issuance of common stock in connection with employee stock purchase plan | 384 | $ 384 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 14,135 | |||
Stock-based compensation expense | 3,921 | $ 3,921 | ||
Foreign currency translation adjustment | 7 | 7 | ||
Net loss | (2,636) | (2,636) | ||
Balance at Mar. 31, 2023 | $ 192,625 | $ 674,156 | $ (218) | $ (481,313) |
Balance, Shares at Mar. 31, 2023 | 32,534,003 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (2,636) | $ (10,562) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 1,287 | 507 |
Stock-based compensation expense | 3,921 | 2,310 |
Non-cash interest expense and end of term accretion expense | 106 | 137 |
Non-cash lease expense | 191 | 178 |
Net amortization of premiums on marketable securities | 228 | |
Unrealized foreign currency transaction (gains) losses | (137) | 214 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (10,962) | (5,804) |
Inventory | (3,623) | (2,926) |
Prepaid expenses and other current assets | (884) | 88 |
Other non-current assets | (54) | |
Accounts payable | 1,028 | (4,013) |
Accrued expenses and other current liabilities | 3,454 | (4) |
Operating lease liabilities | (352) | 1,241 |
Net cash used in operating activities | (8,661) | (18,406) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (927) | (1,953) |
Purchases of marketable securities | (2,033) | |
Proceeds from sales and maturities of marketable securities | 14,500 | |
Net cash provided by (used in) investing activities | (927) | 10,514 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock upon exercise of stock options | 3,574 | 202 |
Proceeds from issuance of common stock in connection with employee stock purchase plan | 384 | 203 |
Net cash provided by financing activities | 3,958 | 405 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 73 | (196) |
Net decrease in cash, cash equivalents and restricted cash | (5,557) | (7,683) |
Cash, cash equivalents and restricted cash, beginning of period | 201,682 | 26,080 |
Cash, cash equivalents and restricted cash, end of period | 196,125 | 18,397 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Transfers of inventory to property and equipment | 317 | 1,030 |
Purchases of property and equipment included in accounts payable and accrued expenses | 30 | 939 |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 195,375 | 17,897 |
Restricted cash | 750 | 500 |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 196,125 | $ 18,397 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | 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 Company also developed its National OCS Program (“NOP”), an innovative turnkey solution to provide outsourced organ retrieval and OCS organ management, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. 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 $ 2.6 million for the three months ended March 31, 2023 and $ 36.2 million for the year ended December 31, 2022. As of March 31, 2023, the Company had an accumulated deficit of $ 481.3 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company believes that its existing cash of $ 195.4 million as of March 31, 2023 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 decreased overall frequency of transplant procedures; 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, a further prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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, 2022 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 March 31, 2023 and results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022 have been made. The Company’s results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. 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 unaudited 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 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 March 31, 2023 and December 31, 2022, the Company had no allowance for credit losses. Significant customers are those that accounted for 10 % or more of the Company’s revenue or accounts receivable. For the three months ended March 31, 2023 , no customer accounted for more than 10 % of revenue. For the three months ended March 31, 2022 , three customers accounted for 16 %, 15 % and 12 % of revenue, respectively. As of March 31, 2023 and December 31, 2022 , no customer accounted for more than 10 % of accounts receivable. 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, as are sterilization services. Although the Company seeks to reduce dependence on those limited sources of suppliers, manufacturers and service providers, 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. 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 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 months ended March 31, 2023 and 2022. 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 March 31, 2023 2022 Warrants to purchase common stock 14,440 64,440 Options to purchase common stock 3,167,730 3,484,914 Employee stock purchase plan 6,511 5,794 Restricted stock units 182,911 — Restricted stock awards 24,315 — 3,395,907 3,555,148 |
Marketable Securities and Fair
Marketable Securities and Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Marketable Securities and Fair Value Measurements [Abstract] | |
Marketable Securities and Fair Value Measurements | 3. Marketable Securities and Fair Value Measurements The Company did no t have marketable securities as of March 31, 2023 or December 31, 2022. The Company also did no t have assets or liabilities measured at fair value on a recurring basis as of March 31, 2023 or December 31, 2022. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory Inventory consisted of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 12,265 $ 10,939 Work-in-process 2,264 1,876 Finished goods 9,432 7,790 $ 23,961 $ 20,605 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued payroll and related expenses $ 10,991 $ 9,812 Accrued logistics costs 5,415 2,581 Accrued research, development and clinical trials expenses 1,918 1,876 Accrued professional fees 1,600 965 Accrued other 2,657 3,401 $ 22,581 $ 18,635 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 6. Long-Term Debt Long-term debt consisted of the following (in thousands): March 31, 2023 December 31, 2022 Principal amount of long-term debt $ 60,000 $ 60,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 60,000 60,000 Debt discount, net of accretion ( 1,198 ) ( 1,304 ) Long-term debt, net of discount and current portion $ 58,802 $ 58,696 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”). In connection with the CIBC Credit Agreement, the Company repaid all amounts due under its previously outstanding credit agreement with OrbiMed Royalty Opportunities II, LP, 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 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 statements of operations. 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 . As certain revenue milestones were met in the three months ended March 31, 2023, the Company will be able to 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 March 31, 2023, 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 March 31, 2023, the interest rate applicable to borrowings under the CIBC Credit Agreement was 6.6 % . During the three months ended March 31, 2023, the weighted average effective interest rate on outstanding borrowings under the CIBC Credit Agreement was approximately 7.3 % . |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders Equity Note [Abstract] | |
Stock-Based Compensation | 7. 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 awards have been or 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 March 31, 2023, 400,541 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 were initially reserved for issuance under the 2019 ESPP. During the three months ended March 31, 2023, 14,135 shares of common stock were issued under the 2019 ESPP and as of March 31, 2023 , 276,318 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 nonqualified 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 March 31, 2023, 458,384 shares of common stock remained available for issuance under the Inducement Plan. Stock Option Activity During the three months ended March 31, 2023, the Company granted options under the 2019 Plan and the Inducement Plan with service-based vesting for the purchase of an aggregate of 326,751 shares of common stock with a weighted average grant-date fair value of $ 43.26 per share. Restricted Stock Unit Activity During the three months ended March 31, 2023, the Company granted 182,911 restricted stock units under the 2019 Plan and the Inducement Plan with service-based vesting conditions and a weighted-average grant-date fair value of $ 66.10 per share. 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 March 31, 2023 2022 Cost of revenue $ 49 $ 25 Research, development and clinical trials expenses 518 321 Selling, general and administrative expenses 3,354 1,964 $ 3,921 $ 2,310 As of March 31, 2023, total unrecognized compensation cost related to unvested share-based awards was $ 44.3 million, which is expected to be recognized over a weighted average period of 2.6 years. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. 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 three months ended March 31, 2023. 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, 2022. 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 March 31, 2023 and December 31, 2022 , 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 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 March 31, 2023 and December 31, 2022. 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 March 31, 2023 was $ 7.0 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. |
Segment Reporting and Geographi
Segment Reporting and Geographic Data | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
Segment Reporting and Geographic Data | 9. Segment Reporting and Geographic Data The Company has determined that it operates in one segment (see Note 2). See Note 10 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands): March 31, 2023 December 31, 2022 Long-lived assets by country(1): United States $ 18,479 $ 18,568 All other countries 682 655 Total long-lived assets $ 19,161 $ 19,223 (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. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 10. Revenue Payments to Customers 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. There were no such adjustments to revenue for either of the three months ended March 31, 2023 or 2022. 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 $ 0.1 million and $ 0.5 million for the three months ended March 31, 2023 and 2022, respectively, as operating expenses. Disaggregated Revenue The Company disaggregates revenue from contracts with customers by organ 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 March 31, 2023 2022 Revenue by country by organ(1): United States Lung total revenue $ 1,431 $ 1,951 Heart total revenue 12,956 3,741 Liver total revenue 23,114 7,869 Total United States revenue 37,501 13,561 All other countries Lung revenue 251 348 Heart revenue 3,802 1,971 Total all other countries revenue 4,053 2,319 Total revenue $ 41,554 $ 15,880 (1) Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 11. 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 in total compensation for each of the three months ended March 31, 2023 and 2022 , for her services as an employee. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | 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, 2022 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 March 31, 2023 and results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022 have been made. The Company’s results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. |
Use of Estimates | 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 unaudited 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 | 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 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 March 31, 2023 and December 31, 2022, the Company had no allowance for credit losses. Significant customers are those that accounted for 10 % or more of the Company’s revenue or accounts receivable. For the three months ended March 31, 2023 , no customer accounted for more than 10 % of revenue. For the three months ended March 31, 2022 , three customers accounted for 16 %, 15 % and 12 % of revenue, respectively. As of March 31, 2023 and December 31, 2022 , no customer accounted for more than 10 % of accounts receivable. 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, as are sterilization services. Although the Company seeks to reduce dependence on those limited sources of suppliers, manufacturers and service providers, 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. |
Fair Value Measurements | 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 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 | 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 | 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 months ended March 31, 2023 and 2022. 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 March 31, 2023 2022 Warrants to purchase common stock 14,440 64,440 Options to purchase common stock 3,167,730 3,484,914 Employee stock purchase plan 6,511 5,794 Restricted stock units 182,911 — Restricted stock awards 24,315 — 3,395,907 3,555,148 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings 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 March 31, 2023 2022 Warrants to purchase common stock 14,440 64,440 Options to purchase common stock 3,167,730 3,484,914 Employee stock purchase plan 6,511 5,794 Restricted stock units 182,911 — Restricted stock awards 24,315 — 3,395,907 3,555,148 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consisted of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 12,265 $ 10,939 Work-in-process 2,264 1,876 Finished goods 9,432 7,790 $ 23,961 $ 20,605 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued payroll and related expenses $ 10,991 $ 9,812 Accrued logistics costs 5,415 2,581 Accrued research, development and clinical trials expenses 1,918 1,876 Accrued professional fees 1,600 965 Accrued other 2,657 3,401 $ 22,581 $ 18,635 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-term debt consisted of the following (in thousands): March 31, 2023 December 31, 2022 Principal amount of long-term debt $ 60,000 $ 60,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 60,000 60,000 Debt discount, net of accretion ( 1,198 ) ( 1,304 ) Long-term debt, net of discount and current portion $ 58,802 $ 58,696 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders Equity Note [Abstract] | |
Schedule of Stock-Based Compensation Expense | The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands): Three Months Ended March 31, 2023 2022 Cost of revenue $ 49 $ 25 Research, development and clinical trials expenses 518 321 Selling, general and administrative expenses 3,354 1,964 $ 3,921 $ 2,310 |
Segment Reporting and Geograp_2
Segment Reporting and Geographic Data (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
Long-lived assets by geographical area | See Note 10 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands): March 31, 2023 December 31, 2022 Long-lived assets by country(1): United States $ 18,479 $ 18,568 All other countries 682 655 Total long-lived assets $ 19,161 $ 19,223 (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. |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Net Revenue by Organ and Country | The Company disaggregates revenue from contracts with customers by organ 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 March 31, 2023 2022 Revenue by country by organ(1): United States Lung total revenue $ 1,431 $ 1,951 Heart total revenue 12,956 3,741 Liver total revenue 23,114 7,869 Total United States revenue 37,501 13,561 All other countries Lung revenue 251 348 Heart revenue 3,802 1,971 Total all other countries revenue 4,053 2,319 Total revenue $ 41,554 $ 15,880 (1) Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||
Net loss | $ 2,636 | $ 10,562 | $ 36,200 |
Accumulated deficit | 481,313 | 478,677 | |
Cash | $ 195,375 | $ 201,182 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) Segment | Mar. 31, 2022 | Dec. 31, 2022 USD ($) | |
Allowance for credit losses | $ | $ 0 | $ 0 | |
Number of operating segments | Segment | 1 | ||
Customer Concentration Risk | Revenue Benchmark | Significant Customer Benchmark [Member] | Minimum [Member] | |||
Concentration risk percentage | 10% | ||
Customer Concentration Risk | Revenue Benchmark | Customer One [Member] | |||
Concentration risk percentage | 16% | ||
Customer Concentration Risk | Revenue Benchmark | Customer Two [Member] | |||
Concentration risk percentage | 15% | ||
Customer Concentration Risk | Revenue Benchmark | Customer Three [Member] | |||
Concentration risk percentage | 12% | ||
Customer Concentration Risk | Accounts Receivable | Significant Customer Benchmark [Member] | Minimum [Member] | |||
Concentration risk percentage | 10% | 10% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 3,395,907 | 3,555,148 |
Warrants to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 14,440 | 64,440 |
Options to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 3,167,730 | 3,484,914 |
Employee stock purchase plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 6,511 | 5,794 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 182,911 | |
Restricted stock awards [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 24,315 |
Marketable Securities and Fai_2
Marketable Securities and Fair Value Measurements - Additional Information (Detail) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Marketable Securities and Fair Value Measurements [Abstract] | ||
Marketable Securities | $ 0 | $ 0 |
Assets measured at fair value | 0 | 0 |
Liabilities measured at fair value | $ 0 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 12,265 | $ 10,939 |
Work-in-process | 2,264 | 1,876 |
Finished goods | 9,432 | 7,790 |
Inventory, net | $ 23,961 | $ 20,605 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses And Other Current Liabilities [Abstract] | ||
Accrued payroll and related expenses | $ 10,991 | $ 9,812 |
Accrued logistics costs | 5,415 | 2,581 |
Accrued research, development and clinical trials expenses | 1,918 | 1,876 |
Accrued professional fees | 1,600 | 965 |
Accrued other | 2,657 | 3,401 |
Accrued expenses and other liabilities current | $ 22,581 | $ 18,635 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Principal amount of long-term debt | $ 60,000 | $ 60,000 |
Long-term debt, net of current portion | 60,000 | 60,000 |
Debt discount, net of accretion | (1,198) | (1,304) |
Long-term debt, net of discount and current portion | $ 58,802 | $ 58,696 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jul. 31, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||
Long-term Debt, Gross | $ 60,000 | $ 60,000 | |
Orbi Med [Member] | |||
Debt Instrument [Line Items] | |||
Repayments of long-term debt | $ 35,000 | ||
Debt instrument, end of term payment accrued interest | 1,100 | ||
Loss on extinguishment of debt | 600 | ||
Canadian Imperial Bank of Commerce [Member] | |||
Debt Instrument [Line Items] | |||
Interest rate effective percentage | 6.60% | ||
Average effective interest rate | 7.30% | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Long-term Debt, Gross | $ 60,000 | ||
Debt instrument, maturity month and year | 2027-07 | ||
Debt Instrument, Frequency of Periodic Payment | monthly | ||
Interest Only Payment Period | 24 months | ||
Interest Only Payment Additional Extension Period | 1 year | ||
Debt Instrument, Payment Terms | 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. As certain revenue milestones were met in the three months ended March 31, 2023, the Company will be able to extend the interest-only repayment period by one additional year. | ||
Description of covenants | 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. | ||
Minimum liquidity covenant amount | $ 10,000 | ||
Minimum percentage to maintain total net revenue set forth in total revenue plan presented | 75% | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Term Loan [Member] | In Event Of Default [Member] | |||
Debt Instrument [Line Items] | |||
Increasing applicable margin | 2% | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Term Loan [Member] | Upfront Fees and Other Costs [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument discount gross | $ 1,500 | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
LIBOR rate | 1% | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Prior to 12 Months After Closing Date [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, prepayment fee percentage | 2% | ||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | 12 to 24 Months After Closing Date [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Debt instrument, prepayment fee percentage | 1% | ||
Canadian Imperial Bank of Commerce [Member] | Term Secured Overnight Financing Rate [Member] | Credit Agreement [Member] | Interest Rate Option One [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 2% | ||
Canadian Imperial Bank of Commerce [Member] | Term Secured Overnight Financing Rate [Member] | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option One [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
LIBOR rate | 1.50% | ||
Canadian Imperial Bank of Commerce [Member] | Prime Rate | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 4% | ||
Canadian Imperial Bank of Commerce [Member] | Amount Over Federal Funds Effective Rate [Member] | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 0.50% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||
Apr. 15, 2019 | Mar. 31, 2023 | Aug. 31, 2021 | |
Unrecognized compensation cost related to unvested employee and director stock-based awards | $ 44.3 | ||
Weighted average period for unrecognized compensation cost | 2 years 7 months 6 days | ||
2019 Stock Plan [Member] | |||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 3,428,571 | ||
Share based compensation arrangement by share based payment award number of shares available for grant | 400,541 | ||
2019 Stock Plan [Member] | From 2014 Plan [Member] | |||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 1,595,189 | ||
2019 Employee Stock Purchase Plan [Member] | |||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 371,142 | ||
Share based compensation arrangement by share based payment award number of shares available for grant | 276,318 | ||
Purchase price of common stock, percent | 85% | ||
Number of shares issued | 14,135 | ||
2021 Inducement Plan [Member] | Common Stock | |||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 1,000,000 | ||
Share based compensation arrangement by share based payment award number of shares available for grant | 458,384 | ||
2019 Plan and 2021 Inducement Plan [Member] | Common Stock | |||
Options granted | 326,751 | ||
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value | $ 43.26 | ||
2019 Plan and 2021 Inducement Plan [Member] | Restricted stock units [Member] | |||
Shares granted | 182,911 | ||
Share-based compensation arrangement by share-based payment award, grants in period, weighted average grant date fair value | $ 66.10 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Allocated Share-based Compensation Expense | $ 3,921 | $ 2,310 |
Cost of revenue [Member] | ||
Allocated Share-based Compensation Expense | 49 | 25 |
Research, development and clinical trials expenses [Member] | ||
Allocated Share-based Compensation Expense | 518 | 321 |
Selling, general and administrative expenses [Member] | ||
Allocated Share-based Compensation Expense | $ 3,354 | $ 1,964 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended |
Jan. 31, 2021 | Mar. 31, 2023 | Dec. 31, 2022 | |
Defined contribution plan, contribution amount | $ 0 | $ 0 | |
Recorded unconditional purchase commitment, minimum quantity required | $ 9.5 | ||
Recorded unconditional purchase commitment, maturity year and month | 2029-12 | ||
Remaining purchase commitment | $ 7 |
Segment Reporting and Geograp_3
Segment Reporting and Geographic Data - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment Reporting and Geograp_4
Segment Reporting and Geographic Data - Geographic Areas Long-lived Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 19,161 | $ 19,223 |
United States [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | 18,479 | 18,568 |
All Other Countries [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 682 | $ 655 |
[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. |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Research development and clinical trials expenses | $ 0.1 | $ 0.5 |
Revenue - Schedule of Net Reven
Revenue - Schedule of Net Revenue by Organ and Country (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | $ 41,554 | $ 15,880 | |
United States [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | [1] | 37,501 | 13,561 |
All Other Countries [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 4,053 | 2,319 | |
Lung revenue [Member] | United States [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | [1] | 1,431 | 1,951 |
Lung revenue [Member] | All Other Countries [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 251 | 348 | |
Heart revenue [Member] | United States [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | [1] | 12,956 | 3,741 |
Heart revenue [Member] | All Other Countries [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | 3,802 | 1,971 | |
Liver revenue [Member] | United States [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Total revenue | [1] | $ 23,114 | $ 7,869 |
[1] Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Director [Member] | ||
Related Party Transaction [Line Items] | ||
Compensation expense | $ 0.1 | $ 0.1 |