Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 15, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Public Float | $ 857.8 | ||
Entity Common Stock, Shares Outstanding | 27,961,954 | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Title of 12(b) Security | Common Stock, No Par Value | ||
Trading Symbol | TMDX | ||
Security Exchange Name | NASDAQ | ||
Auditor Name | PricewaterhouseCoopers LLP | ||
Auditor Firm ID | 238 | ||
Auditor Location | Boston, Massachusetts | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Definitive Proxy Statement for its 2022 Annual Meeting of Stockholders scheduled to be held on June 1, 2022, which Definitive Proxy will be filed with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year end of December 31, 2021 are incorporated by reference into Part II and Part III of this Form 10-K. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 25,580 | $ 24,581 |
Marketable securities | 66,872 | 101,061 |
Accounts receivable | 5,934 | 6,864 |
Inventory | 14,859 | 11,934 |
Prepaid expenses and other current assets | 5,460 | 2,326 |
Total current assets | 118,705 | 146,766 |
Property and equipment, net | 9,841 | 4,754 |
Restricted cash | 500 | 500 |
Operating lease right-of-use assets | 5,847 | |
Other long-term assets | 6 | |
Total assets | 134,893 | 152,026 |
Current liabilities: | ||
Accounts payable | 6,651 | 1,206 |
Accrued expenses and other current liabilities | 16,337 | 10,410 |
Deferred revenue | 250 | 263 |
Total current liabilities | 23,238 | 11,879 |
Long-term debt, net of discount and current portion | 35,197 | 34,657 |
Operating lease liabilities, net of current portion | 8,604 | |
Deferred rent, net of current portion | 1,599 | |
Total liabilities | 67,039 | 48,135 |
Commitments and contingencies (Note 13) | ||
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; 27,791,615 shares and 27,175,305 shares issued and outstanding at December 31, 2021 and 2020, respectively | 510,488 | 502,217 |
Accumulated other comprehensive loss | (188) | (95) |
Accumulated deficit | (442,446) | (398,231) |
Total stockholders’ equity | 67,854 | 103,891 |
Total liabilities and stockholders’ equity | $ 134,893 | $ 152,026 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Common Stock, No Par Value | ||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 27,791,615 | 27,175,305 |
Common Stock, Shares, Outstanding | 27,791,615 | 27,175,305 |
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 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Income Statement [Abstract] | |||
Net revenue | [1] | $ 30,262 | $ 25,639 |
Cost of revenue | 9,103 | 9,004 | |
Gross profit | 21,159 | 16,635 | |
Operating expenses: | |||
Research, development and clinical trials | 22,304 | 18,831 | |
Selling, general and administrative | 38,283 | 24,188 | |
Total operating expenses | 60,587 | 43,019 | |
Loss from operations | (39,428) | (26,384) | |
Other income (expense): | |||
Interest expense | (3,874) | (3,985) | |
Other income (expense), net | (877) | 1,653 | |
Total other expense, net | (4,751) | (2,332) | |
Loss before income taxes | (44,179) | (28,716) | |
Provision for income taxes | (36) | (32) | |
Net loss | $ (44,215) | $ (28,748) | |
Net loss per share attributable to common stockholders, basic | $ (1.60) | $ (1.16) | |
Net loss per share attributable to common stockholders, diluted | $ (1.60) | $ (1.16) | |
Weighted average common shares outstanding, basic | 27,616,839 | 24,702,764 | |
Weighted average common shares outstanding, diluted | 27,616,839 | 24,702,764 | |
[1] | Net revenue by country is categorized based on the location of the end customer |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (44,215) | $ (28,748) |
Other comprehensive loss: | ||
Foreign currency translation adjustment | (46) | (49) |
Unrealized losses on marketable securities, net of tax of $0 | (47) | (44) |
Total other comprehensive loss | (93) | (93) |
Comprehensive loss | $ (44,308) | $ (28,841) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement Of Income And 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. 28, 2019 | $ 54,649 | $ 424,134 | $ (2) | $ (369,483) |
Balance, Shares at Dec. 28, 2019 | 21,184,524 | |||
Issuance of common stock upon the exercise of common stock options | 227 | $ 227 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 218,084 | |||
Issuance of common stock in connection with employee stock purchase plan | 357 | $ 357 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 22,697 | |||
Issuance of common stock in public offering, net of discounts and issuance costs | 75,085 | $ 75,085 | ||
Issuance of common stock in public offering, net of discounts and issuance costs, Shares | 5,750,000 | |||
Stock-based compensation expense | 2,414 | $ 2,414 | ||
Foreign currency translation adjustment | (49) | (49) | ||
Unrealized losses on marketable securities | (44) | (44) | ||
Net loss | (28,748) | (28,748) | ||
Balance at Dec. 31, 2020 | 103,891 | $ 502,217 | (95) | (398,231) |
Balance, Shares at Dec. 31, 2020 | 27,175,305 | |||
Issuance of common stock upon the exercise of common stock options | $ 974 | $ 974 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 588,461 | 588,461 | ||
Issuance of common stock in connection with employee stock purchase plan | $ 419 | $ 419 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 27,849 | |||
Stock-based compensation expense | 6,878 | $ 6,878 | ||
Foreign currency translation adjustment | (46) | (46) | ||
Unrealized losses on marketable securities | (47) | (47) | ||
Net loss | (44,215) | (44,215) | ||
Balance at Dec. 31, 2021 | $ 67,854 | $ 510,488 | $ (188) | $ (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Statement Of Stockholders Equity [Abstract] | |
Discounts and issuance costs of stock issued | $ 585 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (44,215) | $ (28,748) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 1,817 | 1,577 |
Stock-based compensation expense | 6,878 | 2,414 |
Non-cash interest and end of term accretion expense | 540 | 511 |
Non-cash lease expense | 829 | |
Net amortization of premiums on marketable securities | 1,356 | 634 |
Unrealized foreign currency transaction (gains) losses | 928 | (1,065) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 840 | (218) |
Inventory | (4,894) | (1,740) |
Prepaid expenses and other current assets | (3,151) | (769) |
Accounts payable | 5,090 | (5,802) |
Accrued expenses and other current liabilities | 4,875 | 1,948 |
Deferred revenue | 7 | 60 |
Operating lease liabilities | 236 | |
Deferred rent | 933 | |
Net cash used in operating activities | (28,864) | (30,265) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (3,519) | (455) |
Purchases of marketable securities | (72,024) | (121,793) |
Proceeds from sales and maturities of marketable securities | 104,810 | 80,650 |
Net cash provided by (used) in investing activities | 29,267 | (41,598) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in public offering, net of underwriting discounts and commissions | 75,670 | |
Payments of public offering and other financing costs | (705) | |
Proceeds from issuance of common stock upon exercise of stock options | 974 | 227 |
Proceeds from issuance of common stock in connection with employee stock purchase plan | 419 | 357 |
Proceeds from Paycheck Protection Program loan | 2,249 | |
Repayment of Paycheck Protection Program loan | (2,249) | |
Net cash provided by financing activities | 1,393 | 75,549 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (797) | 803 |
Net increase in cash, cash equivalents and restricted cash | 999 | 4,489 |
Cash, cash equivalents and restricted cash, beginning of period | 25,081 | 20,592 |
Cash, cash equivalents and restricted cash, end of period | 26,080 | 25,081 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 3,334 | 3,475 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Transfers of inventory to property and equipment | 1,823 | 1,191 |
Purchases of property and equipment included in accounts payable and accrued expenses | 1,200 | |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 25,580 | 24,581 |
Restricted cash | 500 | 500 |
Cash, cash equivalents and restricted cash, end of period | $ 26,080 | $ 25,081 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | 1. 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 $44.2 million and $28.7 million for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company had an accumulated deficit of $442.4 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company believes that its existing cash, cash equivalents, and marketable securities of $92.5 million as of December 31, 2021 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 Annual Report on Form 10-K. 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. Potential risks and uncertainties also include, without limitation, uncertainties regarding the duration and magnitude of the impact of the COVID-19 pandemic on the Company’s business and the economy generally. 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. Impacts to the Company’s business as a result of COVID-19 have included the temporary disruption of transplant procedures at many of the organ transplant centers that purchase OCS products; customer delays or reductions in customer capital expenditures and operating budgets and the related impact on our product sales; disruptions to the Company’s manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts; labor shortages; decreased productivity and unavailability of materials or components; delays of reviews and approvals by the Food and Drug Administration (“FDA”) and other health authorities; delays in the Company’s clinical trial enrollment; 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. In response to the pandemic, healthcare providers have, and may need to further, reallocate resources, such as physicians, staff, hospital beds and intensive care unit facilities, and these actions significantly delay the provision of other medical care such as organ transplantation and reduce the number of transplant procedures that are performed, which negatively impacts the Company’s revenue and cash flows. While the Company maintains an inventory of finished products and raw materials used in its OCS products, a prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products. The COVID-19 pandemic also has impacted operations at the FDA and other health authorities, resulting in delays of reviews and approvals, and may affect other potential Pre-Market Approval (“PMA”) applications. 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”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. 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. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. The Company has made estimates of the impact of COVID-19 within its financial statements and there may be changes to those estimates in future periods. As of the date of issuance of these 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. 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 has not experienced any other-than-temporary losses with respect to its cash, cash equivalents and marketable securities and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Significant customers are those that accounted for 10% 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. Deferred Financing Costs Deferred financing costs related to a recognized debt liability are recorded as a reduction of the carrying amount of the debt liability and amortized to interest expense using the effective interest method over the repayment term of the debt. Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Restricted Cash As of December 31, 2021 and 2020, the Company maintained two letters of credit totaling $0.5 Accounts Receivable Accounts receivable are presented net of an allowance for credit losses, which is an estimate of amounts that may not be collectible. The Company performs ongoing credit evaluations of its customers and monitors economic conditions to identify facts and circumstances that may indicate its receivables are at risk of collection. The Company provides reserves against accounts receivable for estimated credit losses, if any, that may result from a customer’s inability to pay based on the composition of its accounts receivable, current economic conditions and historical credit loss activity. Amounts deemed uncollectible are charged or written-off against the reserve. As of December 31, 2021 and 2020, the Company had no allowance for credit losses. During the years ended December 31, 2021 and 2020, the Company did not record any provisions for credit losses and did not write off any accounts receivable balances. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Manufacturing equipment 5 years OCS Consoles loaned to customers 5 years Computer equipment and software 3 years Laboratory equipment 3 years Office and trade show equipment 5 years Leasehold improvements Shorter of term of lease or 15 years Costs incurred for OCS Consoles are recorded as inventory unless and until the Company determines that an OCS Console will be loaned to a customer for its use. When an OCS Console is loaned to a customer, the Company reclassifies the cost of the OCS Console from inventory to property and equipment and begins to depreciate the loaned OCS Console over its estimated life. Related depreciation expense for the loaned OCS Console is classified as a cost of revenue. If an OCS Console is returned to the Company, it will continue to be classified as property and equipment and depreciated over its remaining useful life. The Company retains title to all OCS Consoles loaned to customers. Other than for OCS Consoles loaned to customers, costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not record any impairment losses on long-lived assets during the years ended December 31, 2021 and 2020. Software Development Costs The Company incurs costs to develop computer software that is embedded in the hardware components of the Company’s OCS Console and OCS Perfusion Sets. Research and development costs related to this software are expensed as incurred, except for costs of internally developed or externally purchased software that qualify for capitalization. Software development costs incurred subsequent to the establishment of technological feasibility, but prior to the general release of the product, are capitalized and, upon general release, are amortized based upon the pattern in which economic benefits related to such assets are realized. Due to the short time period between achieving technological feasibility and product release and the insignificant amount of costs incurred during such periods, the Company did not capitalize any software development costs during the years ended December 31, 2021 and 2020. Inventory Inventory is valued at the lower of cost or net realizable value. Cost is computed using the first-in, first-out method. The Company regularly reviews inventory quantities on-hand for excess and obsolete inventory and, when circumstances indicate, records charges to write down inventories to their estimated net realizable value, after evaluating historical sales, future demand, market conditions and expected product life cycles. Such charges are classified as cost of revenue in the consolidated statements of operations. Any write-down of inventory to net realizable value creates a new cost basis. At the end of each reporting period, the Company assesses whether losses should be accrued on long-term manufacturing purchase commitments in accordance with Accounting Standards Codification (“ASC”) 330, Inventory Leases Prior to January 1, 2021, the Company accounted for leases under ASC 840, Leases (“ASC 840”). Effective January 1, 2021, the Company accounts for leases under ASC 842, Leases (“ASC 842”). Therefore, as of and for the year ended December 31, 2020, the Company’s consolidated financial statements continue to be presented in accordance with ASC 840, the accounting standard originally in effect for such period. As of and for the year ended December 31, 2021, the Company’s consolidated financial statements are presented in accordance with ASC 842. In accordance with ASC 842, the Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines if an arrangement is a lease or contains an embedded lease at inception. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use asset and lease liability at the lease commencement date and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. The Company’s policy is to not record leases with an original term of twelve months or less on its consolidated balance sheets and recognizes those lease payments in the income statement on a straight-line basis over the lease term. The Company’s existing leases are for office, laboratory and manufacturing space. In addition to rent, the leases may require the Company to pay additional costs, such as utilities, maintenance and other operating costs, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and lease liability. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations. Revenue from leasing arrangements is not subject to the revenue standard for contracts with customers and remains separately accounted for under ASC 842. In accordance with ASC 842, lessors should classify and account for a lease with variable lease payments that do not depend on a reference index or a rate as an operating lease if the lease would have been classified as a sales-type lease or a direct financing lease and the lessor would have otherwise recognized a day-one loss. The Company’s OCS Console implied rental agreements qualify as sales-type leases with certain variable payments that meet specified criteria such that a day-one l oss would be recognized under ASC 842. Therefore, in accordance with ASC 842, such leases are accounted for as operating leases and the Company does not derecognize the leased asset (the OCS Console) at the time of the sale but depreciates the leased asset over the useful life of the asset . 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. Marketable Securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations. When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the consolidated statements of operations. Credit losses are recognized through the use of an allowance for credit losses account in the consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations. There were no credit losses recorded during the years ended December 31, 2021 and 2020. Segment Information The Company manages its operations as a single Product Warranties The Company provides a one-year Company may be refurbished and redeployed. Estimated warranty costs are recorded at the time of shipment of the OCS Console or disposable set. Warranty costs are estimated based on the current expected product replacement or repair cost and expected replacement or repair rates based on historical experience. The Company evaluates its warranty accrual at the end of each reporting period and makes adjustments as necessary. As of December 31, 202 1 and 2020 , the warranty accrual was less than $0.1 million. Revenue Recognition The Company generates revenue primarily from sales of its single-use, organ-specific disposable sets (i.e., its organ-specific OCS Perfusion Sets sold together with its organ-specific OCS Solutions) used on its organ-specific OCS Consoles, each being a component of the Company’s OCS products. To a lesser extent, the Company also generates revenue from the sale of OCS Consoles to customers and from the implied rental of OCS Consoles loaned to customers at no charge. For each new transplant procedure, customers purchase an additional OCS disposable set for use on the customer’s existing organ-specific OCS Console. The Company recognizes revenue from sales to customers applying the following five steps: (1) identification of the contract, or contracts, with a customer, (2) identification of the performance obligations in the contract, (3) determination of the transaction price, (4) allocation of the transaction price to the performance obligations in the contract, and (5) recognition of revenue when, or as, performance obligations are satisfied. Substantially all of the Company’s customer contracts have multiple-performance obligations that contain deliverables consisting of OCS Perfusion Sets and OCS Solutions. In some of those customer contracts, the deliverables also include an OCS Console, whether sold or loaned to the customer. The Company evaluates each promise within a multiple-performance obligation arrangement to determine whether it represents a distinct performance obligation. The primary performance obligations in the Company’s customer arrangements from which it derives revenue are the OCS Perfusion Sets, the OCS Solutions and the OCS Console. Revenue for each OCS Perfusion Set and OCS Solutions is recognized at the point in time at which control is transferred to the customer, which is when title transfers to the customer, typically upon arrival at the customer site. When a customer order includes an OCS Console, the Company has determined that customer training and the equipment set-up of the OCS Console, each performed by the Company, are not distinct because they are not sold on a standalone basis and can only be performed by the Company in conjunction with a sale or loan of its OCS Console. In addition, the Company has determined that the OCS Console itself is not distinct because the customer cannot benefit from the OCS Console without the training and equipment set-up having been completed. As a result, when the order includes an OCS Console, the Company has concluded that training, OCS Console equipment set-up, and the OCS Console itself are highly interdependent and represent a single, combined performance obligation. The Company recognizes revenue from the single, combined performance obligation only once the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by the Company. Customer orders may include the loan of an OCS Console as well as OCS disposable sets. When the Company loans the OCS Console to the customer, it retains title to the console at all times and does not require minimum purchase commitments from the customer related to any OCS products. In such cases, the Company invoices the customer for OCS disposable sets based on customer orders received and the prices set forth in the customer agreement. Over time, the Company typically recovers the cost of the loaned OCS Console through the customer’s continued purchasing of OCS disposable sets. For these reasons, the Company has determined that part of the arrangement consideration for the disposable set is an implied rental payment for use of the OCS Console. Therefore, the Company allocates the arrangement consideration between the lease deliverables (i.e., the OCS Console) and non-lease deliverables (i.e., the OCS disposable sets) based on the relative estimated standalone selling price of each distinct performance obligation. To date, the amounts allocated to lease deliverables have been insignificant. Because all performance obligations of a customer order are delivered and recognized as revenue at the same time and because revenue allocated to performance obligations other than OCS disposable sets, such as implied rental income and service revenue, is insignificant, all components of revenue from customer arrangements are classified as a single category of revenue in the Company’s consolidated statements of operations. Revenue is recognized when control of the OCS product or products is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for the product or products. Payments Made to Customers Under the Company’s customer arrangements that include a customer clinical trial agreement, the Company makes payments to that customer for reimbursements of clinical trial costs, materials, and for specified clinical documentation related to the customer’s use of its OCS products. The Company also makes payments to customers involved in post-approval studies for information related to the transplant procedures performed. The Company determines the appropriate accounting treatments for these payments depending on the nature of the payment and whether they are for distinct goods or services. 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 December 31, 2021 and 2020 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. The Company generally satisfies performance obligations within one year of the contract inception date. As of December 31, 2021 Other Revenue Considerations Revenue is reported net of taxes. The Company does not consider shipping to be a contract performance obligation, therefore shipping costs incurred and billed to customers are recorded as revenue and cost of revenue. The Company only includes estimated variable amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. The Company does not assess whether promised goods or services are performance obligations if they are deemed immaterial in the context of the contract with the customer. Additionally, the Company does not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Distributors The Company markets and sells its products primarily through its direct sales force, which sells its products to end customers globally. A small portion of the Company’s revenue is generated by sales to a limited number of distributors in Europe and Asia-Pacific. When the Company transacts with a distributor, its contractual arrangement is with the distributor and not with the end customer. Whether the Company transacts business with and receives the order from a distributor or directly from an end customer, its revenue recognition policy and resulting pattern of revenue recognition for the order are the same. Research, Development and Clinical Trials Costs Research, development and clinical trials expenses consist of costs incurred for research activities, product development, hardware and software engineering and clinical trial activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, testing, regulatory, data management and consulting costs. Research, development and clinical trials costs are expensed as incurred. Advance payments for goods or services to be received in the future for use in research, development and clinical trials activities are recorded as prepaid expenses. Such prepaid expenses are recognized as an expense when the related goods have been delivered or the related services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Foreign Currency Translation The functional currency of each of the Company’s foreign subsidiaries is the currency of the local country. Assets and liabilities of the Company’s foreign subsidiaries are translated into U.S. dollars using the period-end exchange rates, and income and expense items are translated into U.S. dollars using average exchange rates in effect during each period. The effects of these foreign currency translation adjustments are included in accumulated other comprehensive loss, a separate component of stockholders’ equity. The Company also incurs transaction gains and losses resulting from intercompany transactions as well as transactions with customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded. Realized and unrealized foreign currency transaction gains (losses) are included in the consolidated statements of operations as a component of other income (expense) and totaled ($1.0) million and $1.0 million for the years ended December 31, 2021 and 2020, respectively. Stock-Based Compensation The Company measures stock-based option awards granted to employees, non-employees and directors based on their fair value on the date of grant using the Black-Scholes option-pricing model. Generally, the Company issues awards with only service-based vesting conditions. Compensation expense for those awards is recognized over the vesting period of the respective award using the straight-line method. The Company accounts for forfeitures as they occur and records compensation cost assuming all option holders will complete the requisite service period. When the unvested portion of an award is forfeited, the Company reverses compensation expense previously recognized in the period of the forfeiture. The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. Comprehensive Loss and Accumulated Other Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only elements of other comprehensive loss are foreign currency translation adjustments and unrealized gains (losses) on marketable securities. Accumulated other comprehensive gains (losses) on the consolidated balance sheets consists primarily of foreign currency translation adjustments. Accumulated other comprehensive loss attributable to unrealized losses on marketable securities has not been significant. 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 years ended December 31, 2021 and 2020. 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 December 31, 2021 2020 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 2,797,550 2,261,234 Employee stock purchase plan 12,465 14,951 2,874,455 2,340,625 Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company's tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be realized and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by analyzing carryback capacity in periods with taxable income, reversal of existing taxable temporary differences and estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. Recently Adopted Accounting Pronouncements The Company adopted ASU No. 2016-02, Leases (Topic 842), inclusive of ASU 2021-05 Leases (Topic 842): Lessors – Certain Leases with Variable Lease Payments, effective January 1, 2021, using the modified retrospective method under ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. Since the Company ceased to be an emerging growth company as of December 31, 2021, the Company adopted the standard during the fourth quarter of 2021 effective as of January 1, 2021. The modified retrospective transition method allows entities to apply the transition requirements at the effective date rather than at the beginning of the earliest comparative period presented. The Company’s reporting for comparative periods was not recast and is presented in accordance with ASC 840. Adoption of the new standard resulted in the re |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | 3. Marketable securities by security type consisted of the following (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized 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 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Treasury securities (due within one year) $ 74,066 $ 10 $ (3 ) $ 74,073 U.S. government agency bonds (due within one year) 26,984 4 — 26,988 $ 101,050 $ 14 $ (3 ) $ 101,061 |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 4 . The following tables present the Company’s fair value hierarchy for its assets that are measured at fair value on a recurring basis (in thousands): 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 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 13,829 $ — $ — $ 13,829 Marketable securities: U.S. Treasury securities — 74,073 — 74,073 U.S. government agency bonds — 26,988 — 26,988 $ 13,829 $ 101,061 $ — $ 114,890 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. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 5 . Inventory consisted of the following (in thousands): December 31, 2021 2020 Raw materials $ 7,274 $ 6,770 Work-in-process 1,932 1,102 Finished goods 5,653 4,062 $ 14,859 $ 11,934 During the years ended December 31, 2021 and 2020, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $1.8 million and $1.2 million, respectively. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 6 . Property and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Manufacturing equipment $ 1,769 $ 1,725 OCS Consoles loaned to customers 8,865 7,196 Computer equipment and software 1,511 1,338 Laboratory equipment 668 617 Office and trade show equipment 177 177 Leasehold improvements 1,319 1,319 Construction-in-progress 5,267 409 19,576 12,781 Less: Accumulated depreciation and amortization (9,735 ) (8,027 ) $ 9,841 $ 4,754 During the years ended December 31, 2021 and 2020, total depreciation and amortization expense was $1.8 million and $1.6 million, respectively. Of those amounts, $1.4 million and $1.3 million, respectively, was recorded as expense in cost of revenue related to the depreciation of OCS Consoles loaned to customers. The Company retains title to OCS Consoles loaned to customers. Construction-in-progress recorded as of December 31, 2021 and 2020 was primarily related to leasehold improvements and in-process construction of manufacturing equipment, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | 7 . Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued research, development and clinical trial expenses $ 4,567 $ 4,426 Accrued payroll and related expenses 5,173 4,030 Accrued professional fees 1,973 344 Accrued other 4,624 1,610 $ 16,337 $ 10,410 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 8 . TransMedics has a credit agreement (the “Credit Agreement”) with OrbiMed Royalty Opportunities II, LP (“OrbiMed”), entered into in June 2018, pursuant to which TransMedics borrowed $35.0 million. Long-term debt consisted of the following (in thousands): December 31, 2021 2020 Principal amount of long-term debt $ 35,000 $ 35,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 35,000 35,000 Debt discount, net of accretion (511 ) (834 ) Accrued end-of-term payments 708 491 Long-term debt, net of discount and current portion $ 35,197 $ 34,657 Borrowings under the Credit Agreement bear 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 Credit Agreement bear paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeds 11.5%, but not to exceed 12.5%. The PIK interest is added to the principal amount of the borrowings outstanding at the end of each quarter until the maturity date of the Credit Agreement in June 2023. Borrowings under the Credit Agreement are repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest is due and payable. At its option, the Company may prepay outstanding borrowings under the Credit Agreement. The Company is also 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 are being accreted to interest expense over the term of the Credit Agreement using the effective interest method. All obligations under the 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, including a perfected security interest in substantially all tangible and intangible assets of the Company and each guarantor. Under the Credit Agreement, the Company has agreed to certain affirmative and negative covenants to which it will remain subject until maturity. The financial covenants include maintaining a minimum liquidity amount of $3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from the Company’s independent registered public accounting firm; and restrictions on the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. As of December 31, 2021, the Company was in compliance with the financial covenants under the Credit Agreement. The obligations under the Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in the Company’s business), failure to comply with certain covenants, including the minimum liquidity and unqualified audit opinion covenants, and a material adverse change in the Company’s business, operations or other financial condition. Upon the occurrence of an event of default and until such event of default is no longer continuing, the Applicable Margin will increase by 4.0 % per annum. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, OrbiMed may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, 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. As of December 31, 2021 and 2020, the interest rate applicable to borrowings under the Credit Agreement was 9.5%. During each of the years ended December 31, 2021 and 2020, the weighted average effective interest rate on outstanding borrowings under the Credit Agreement was approximately 11.2%. Paycheck Protection Program Loan On April 20, 2020, TransMedics issued a Promissory Note to Bank of America, NA, pursuant to which it received loan proceeds of $2.2 million (the “Loan”) provided under the Paycheck Protection Program established under the Coronavirus Aid, Relief, and Economic Security Act and guaranteed by the U.S. Small Business Administration (the “Paycheck Protection Program”). However, based on updated guidance related to this program, the Company decided to repay the full amount of the Loan, and repaid the Loan on May 1, 2020. The Loan was unsecured, was scheduled to mature on April 20, 2022, had a fixed interest rate of 1.0% per annum and was subject to the standard terms and conditions applicable to loans administered under the Paycheck Protection Program. |
Equity
Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Equity | 9. Equity Preferred Stock As of December 31, 2021, the Company’s articles of organization authorized the Company to issue up to 25,000,000 no The preferred stock will have such rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be determined by the Company’s boards of directors upon issuance. Common Stock As of December 31, 2021, the Company’s articles of organization authorized the Company to issue up to 150,000,000 no Warrants As of December 31, 2021, the Company had outstanding warrants to purchase 50,000 shares of common stock at an exercise price of $8.75 per share with an expiration date of November 7, 2022 and warrants to purchase 14,440 shares of common stock at an exercise price of $17.47 per share with an expiration date of May 6, 2024. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Stock-Based Compensation | 1 0 . 2019 Stock Incentive Plan and Option Grants The 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 cancelled 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 December 31, 202 1 , 1,583,925 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 common stock of TransMedics Group are reserved for issuance under the 2019 ESPP as of December 31, 2021. During the year ended December 31, 2021, 27,849 shares were issued under the 2019 ESPP and as of December 31, 2021, 320,596 shares 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 December 31, 2021, 738,700 shares of common stock were available for issuance under the Inducement Plan. Stock Option Valuation The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. Prior to the IPO, the Company was a private company and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted to employees and directors: Year Ended December 31, 2021 2020 Risk-free interest rate 0.90 % 0.91 % Expected term (in years) 6.03 5.97 Expected volatility 58 % 54 % Expected dividend yield 0 % 0 % The following table summarizes the Company’s option activity since December 31, 2020: Number of Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (in years) (in thousands) Outstanding as of December 31, 2020 2,261,234 $ 8.17 6.22 $ 26,671 Granted 1,326,675 34.60 Exercised (588,461 ) 1.65 Forfeited (200,060 ) 28.10 Expired (1,838 ) 31.76 Outstanding as of December 31, 2021 2,797,550 $ 20.64 7.54 $ 14,625 Vested and expected to vest as of December 31, 2021 2,797,550 $ 20.64 7.54 $ 14,625 Options exercisable as of December 31, 2021 1,371,048 $ 11.80 6.11 $ 13,143 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2021 and 2020, was $16.3 million and $2.9 million, respectively. The weighted average grant-date fair value of stock options granted during the years ended December 31, 2021 and 2020 was $18.63 per share and $7.91 per share, respectively. The Company has not granted to employees any stock-based awards with performance-based vesting conditions. Stock-Based Compensation The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands): Year Ended December 31, 2021 2020 Cost of revenue $ 72 $ 27 Research, development and clinical trials expenses 1,114 396 Selling, general and administrative expenses 5,692 1,991 $ 6,878 $ 2,414 As of December 31, 2021, total unrecognized compensation cost related to unvested share-based awards was $20.9 million, which is expected to be recognized over a weighted average period of 2.7 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 1 1 . Tax Provision Components During the years ended December 31, 2021 and 2020, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each year in the United States, due to the uncertainty regarding the realizability of these respective deferred tax assets. The Company generated income in the Netherlands for the years ended December 31, 2021 and 2020 and, accordingly, recorded a foreign income tax provision of less than $ 0.1 Income Before Taxes The domestic and foreign components of loss before income taxes were as follows (in thousands): Year Ended December 31, 2021 2020 United States $ (44,321 ) $ (28,803 ) Foreign 142 87 $ (44,179 ) $ (28,716 ) A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate (21.0 )% (21.0 )% State taxes, net of federal benefit (6.9 )% (5.7 )% Federal and state research and development tax credits (2.4 )% (3.6 )% Nondeductible items (3.2 )% (0.2 )% Deferred tax effect of change in state blended rate (1.7 )% 7.8 % Return to provision 1.1 % 1.7 % Other (0.2 )% 0.0 % Change in deferred tax asset valuation allowance 34.3 % 20.9 % Effective income tax rate 0.0 % (0.1 )% Net deferred tax assets consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 94,672 $ 81,390 Capitalized research and development expense 4,291 6,136 Research and development tax credit carryforwards 12,186 11,541 Accrued expenses 2,528 1,390 Stock-based compensation expense 2,254 791 Deferred rent — 79 Lease liability 2,299 — Other 170 132 Total deferred tax assets 118,400 101,459 Deferred tax liabilities: Other (674 ) (218 ) Right-of-use assets (1,562 ) — Unrealized gain (loss) — (212 ) Total deferred tax liabilities (2,236 ) (430 ) Valuation allowance (116,164 ) (101,029 ) Net deferred tax assets $ — $ — As of December 31, 2021, the Company had U.S. federal and state net operating loss carryforwards of $368.1 million and $304.0 Utilization of the U.S. federal and state net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed by the Company and any limitation is known, no amounts are being presented as an uncertain tax position. As required by Accounting Standard Codification 740, management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards. Management has determined that it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets and, as a result, a valuation allowance of approximately $116.2 million has been recorded. During 2021, the Company recorded a net increase to its valuation allowance in the amount of $15.1 million primarily attributable to the current year operating loss and research credit generation for which the Company cannot provide a tax benefit. The Company had no unrecognized tax benefits or related interest and penalties accrued for the years ended December 31, 2021 and 2020. The Company's policy is to record any interest or penalties related to income taxes as part of the income tax provision. The Company generated research credits for the tax years ending after December 31, 2001 but has not conducted a study to document qualified activities. This study may result in an adjustment to the Company's research and development carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an unrecognized tax benefit for the year ended December 31, 2021. A full valuation allowance has been provided against the Company's research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research credit carryforward and the valuation allowance. The Company files income tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending federal or state tax examinations. The Company has open tax years subject to examination from fiscal year 2018 to present. To the extent that the Company has carryforward attributes, the tax years in which the attribute was generated may still be adjusted upon examination by federal, state or local tax authorities if they either have been or will be used in the future. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021 and 2020 related primarily to the increase in net operating loss carryforwards and research and development tax credit carryforwards in 2021 and 2020, and were as follows (in thousands): Year Ended December 31, 2021 2020 Valuation allowance as of beginning of year $ (101,029 ) $ (95,024 ) Decreases recorded as benefit to income tax provision — — Increases recorded to income tax provision (15,135 ) (6,005 ) Valuation allowance as of end of year $ (116,164 ) $ (101,029 ) As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts had been recognized in the Company’s consolidated statements of operations. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 12. Leases The Company leases its office, laboratory and manufacturing space under two noncancelable leases (the “Leases”) that expire in December 2027 Under the Leases, the landlord will contribute up to $3.4 million towards the Company’s leasehold improvements. lease incentive as a reduction of rental payments used to measure the operating lease liability, and, in turn, the operating lease right-of-use asset upon adoption of ASC 842. The components of the Company’s lease expense under ASC 842 are as follows: Year Ended December 31, 2021 Operating lease cost $ 1,353 Short-term lease cost 159 Variable lease cost 640 $ 2,152 Supplemental disclosure of cash flow information related to the leases were as follows (in thousands): Year Ended December 31, 2021 Cash paid for amounts included in the measurement of operating lease liabilities $ 1,901 Operating lease liabilities arising from obtaining right-of-use assets and leasehold improvements $ — The weighted-average remaining lease term as of December 31, 2021 was 6.0 years. The weighted-average discount rate as of December 31, 2021 was 6.7%. Because the interest rate implicit in the lease was not readily determinable, the Company’s estimated incremental borrowing rate was used to calculate the present value of the Leases. In determining its incremental borrowing rate, the Company considered its credit quality and assessed interest rates available in the market for similar borrowings, adjusted for the impact of collateral over the term of the lease. Future annual lease payments under the Company’s Leases as of December 31, 2021 are as follows (in thousands): Year Ending December 31, 2022 $ 1,948 2023 1,997 2024 2,047 2025 2,098 2026 2,150 Thereafter 2,204 Total future minimum lease payments 12,444 Less: imputed interest (2,273 ) Less: estimated lease incentives (1,567 ) Total operating lease liabilities $ 8,604 The following table represents lease liabilities on the consolidated balance sheet (in thousands): December 31, 2021 Current operating lease liabilities $ — Operating lease liabilities, net of current portion 8,604 Total operating lease liabilities $ 8,604 Under prior lease guidance, minimum lease payments under operating leases were as follows as December 31, 2020 (in thousands): Year Ending December 31, 2021 $ 1,900 2022 1,948 2023 1,997 2024 2,047 2025 2,098 Thereafter 4,354 $ 14,344 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 1 3 . 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 continue 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 has requested a patent term extension for one U.S. patent covered by the VA license agreement, U.S. Patent No. 6100082. The Company was granted an interim patent term extension for this patent until November 6, 2021. The Company has not received final approval of the patent extension beyond the interim patent term extension already requested. The maximum extension granted would be through May 2022; however, the length of the patent term extension will be determined by the United States Patent and Trademark Office (“USPTO”) based on input from the FDA. On February 8, 2021, the FDA provided to the USPTO a determined regulatory review period for the OCS Lung. Under the FDA’s analysis, the patent term extension of the ’082 patent would be until November 6, 2021 The Company has not yet received communication from the USPTO, but expects that the USPTO’s determination of patent term extension for the ’082 patent will maintain the November 6, 2021 expiration date. The final determination of the length of the patent extension 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 is 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 will be 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 is also responsible for all costs related to the amendment, prosecution and maintenance of the licensed patent rights. The Company paid the VA royalties of $0.4 million and $0.3 million during of the years ended December 31, 2021 and 2020, respectively. The Company also accrued VA royalties of $0.2 million and $0.1 million as of December 31, 2021 and 2020, respectively. The VA license agreement can be terminated by the Company or the VA only if the other party fails to cure its material breach within a specified period after receiving notice of such breach. 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. For the years ended December 31, 2021 and 2020, the Company had not 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 December 31, 2021 and 2020. 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 December 31, 2021 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. |
Segment Reporting and Geographi
Segment Reporting and Geographic Data | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Segment Reporting and Geographic Data | 1 4 . The Company has determined that it operates in one segment (see Note 2). Financial data by geographical area is summarized as follows (in thousands): Year Ended December 31, 2021 2020 Net revenue by country: United States $ 21,861 $ 19,239 All other countries 8,401 6,400 Total net revenue $ 30,262 $ 25,639 December 31, 2021 2020 Long-lived assets by country(1): United States $ 9,085 $ 4,114 All other countries 756 640 Total long-lived assets $ 9,841 $ 4,754 (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 | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue | 15. 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): Year Ended December 31, 2021 2020 Gross revenue from sales to customers $ 31,385 $ 28,356 Less: Clinical trial payments reducing revenue 1,123 2,717 Total net revenue $ 30,262 $ 25,639 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 $2.1 million and $1.6 million for the years ended December 31, 2021 and 2020, 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): Year Ended December 31, 2021 2020 Net revenue by OCS product: OCS Lung net revenue $ 10,665 $ 6,194 OCS Heart net revenue 17,683 14,196 OCS Liver net revenue 1,914 5,249 Total net revenue $ 30,262 $ 25,639 Year Ended December 31, 2021 2020 Net revenue by country (1): United States $ 21,861 $ 19,239 All other countries 8,401 6,400 Total net revenue $ 30,262 $ 25,639 (1) Net revenue by country is categorized based on the location of the end customer |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 1 6 . 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, Chief Executive Officer and a member of the Company’s board of directors. The Company paid Dr. Amira Hassanein $0.4 million and $0.3 million in total compensation in the years ended December 31, 2021 and 2020, respectively, for her services as an employee. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
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 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. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. The Company has made estimates of the impact of COVID-19 within its financial statements and there may be changes to those estimates in future periods. As of the date of issuance of these 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. |
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, cash equivalents, marketable securities and accounts receivable. The Company has not experienced any other-than-temporary losses with respect to its cash, cash equivalents and marketable securities and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Significant customers are those that accounted for 10% 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. |
Deferred Financing Costs | Deferred Financing Costs Deferred financing costs related to a recognized debt liability are recorded as a reduction of the carrying amount of the debt liability and amortized to interest expense using the effective interest method over the repayment term of the debt. |
Cash Equivalents | Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. |
Restricted Cash | Restricted Cash As of December 31, 2021 and 2020, the Company maintained two letters of credit totaling $0.5 |
Accounts Receivable | Accounts Receivable Accounts receivable are presented net of an allowance for credit losses, which is an estimate of amounts that may not be collectible. The Company performs ongoing credit evaluations of its customers and monitors economic conditions to identify facts and circumstances that may indicate its receivables are at risk of collection. The Company provides reserves against accounts receivable for estimated credit losses, if any, that may result from a customer’s inability to pay based on the composition of its accounts receivable, current economic conditions and historical credit loss activity. Amounts deemed uncollectible are charged or written-off against the reserve. As of December 31, 2021 and 2020, the Company had no allowance for credit losses. During the years ended December 31, 2021 and 2020, the Company did not record any provisions for credit losses and did not write off any accounts receivable balances. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Manufacturing equipment 5 years OCS Consoles loaned to customers 5 years Computer equipment and software 3 years Laboratory equipment 3 years Office and trade show equipment 5 years Leasehold improvements Shorter of term of lease or 15 years Costs incurred for OCS Consoles are recorded as inventory unless and until the Company determines that an OCS Console will be loaned to a customer for its use. When an OCS Console is loaned to a customer, the Company reclassifies the cost of the OCS Console from inventory to property and equipment and begins to depreciate the loaned OCS Console over its estimated life. Related depreciation expense for the loaned OCS Console is classified as a cost of revenue. If an OCS Console is returned to the Company, it will continue to be classified as property and equipment and depreciated over its remaining useful life. The Company retains title to all OCS Consoles loaned to customers. Other than for OCS Consoles loaned to customers, costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment and right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not record any impairment losses on long-lived assets during the years ended December 31, 2021 and 2020. |
Software Development Costs | Software Development Costs The Company incurs costs to develop computer software that is embedded in the hardware components of the Company’s OCS Console and OCS Perfusion Sets. Research and development costs related to this software are expensed as incurred, except for costs of internally developed or externally purchased software that qualify for capitalization. Software development costs incurred subsequent to the establishment of technological feasibility, but prior to the general release of the product, are capitalized and, upon general release, are amortized based upon the pattern in which economic benefits related to such assets are realized. Due to the short time period between achieving technological feasibility and product release and the insignificant amount of costs incurred during such periods, the Company did not capitalize any software development costs during the years ended December 31, 2021 and 2020. |
Inventory | Inventory Inventory is valued at the lower of cost or net realizable value. Cost is computed using the first-in, first-out method. The Company regularly reviews inventory quantities on-hand for excess and obsolete inventory and, when circumstances indicate, records charges to write down inventories to their estimated net realizable value, after evaluating historical sales, future demand, market conditions and expected product life cycles. Such charges are classified as cost of revenue in the consolidated statements of operations. Any write-down of inventory to net realizable value creates a new cost basis. At the end of each reporting period, the Company assesses whether losses should be accrued on long-term manufacturing purchase commitments in accordance with Accounting Standards Codification (“ASC”) 330, Inventory |
Leases | Leases Prior to January 1, 2021, the Company accounted for leases under ASC 840, Leases (“ASC 840”). Effective January 1, 2021, the Company accounts for leases under ASC 842, Leases (“ASC 842”). Therefore, as of and for the year ended December 31, 2020, the Company’s consolidated financial statements continue to be presented in accordance with ASC 840, the accounting standard originally in effect for such period. As of and for the year ended December 31, 2021, the Company’s consolidated financial statements are presented in accordance with ASC 842. In accordance with ASC 842, the Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines if an arrangement is a lease or contains an embedded lease at inception. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use asset and lease liability at the lease commencement date and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. The Company’s policy is to not record leases with an original term of twelve months or less on its consolidated balance sheets and recognizes those lease payments in the income statement on a straight-line basis over the lease term. The Company’s existing leases are for office, laboratory and manufacturing space. In addition to rent, the leases may require the Company to pay additional costs, such as utilities, maintenance and other operating costs, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and lease liability. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations. Revenue from leasing arrangements is not subject to the revenue standard for contracts with customers and remains separately accounted for under ASC 842. In accordance with ASC 842, lessors should classify and account for a lease with variable lease payments that do not depend on a reference index or a rate as an operating lease if the lease would have been classified as a sales-type lease or a direct financing lease and the lessor would have otherwise recognized a day-one loss. The Company’s OCS Console implied rental agreements qualify as sales-type leases with certain variable payments that meet specified criteria such that a day-one l oss would be recognized under ASC 842. Therefore, in accordance with ASC 842, such leases are accounted for as operating leases and the Company does not derecognize the leased asset (the OCS Console) at the time of the sale but depreciates the leased asset over the useful life of the asset . |
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 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. |
Marketable Securities | Marketable Securities The Company’s marketable securities (non-equity instruments) are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations. When the fair value is below the amortized cost of a marketable security, an estimate of expected credit losses is made. The credit-related impairment amount is recognized in the consolidated statements of operations. Credit losses are recognized through the use of an allowance for credit losses account in the consolidated balance sheet and subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the consolidated statements of operations. There were no credit losses recorded during the years ended December 31, 2021 and 2020. |
Segment Information | Segment Information The Company manages its operations as a single |
Product Warranties | Product Warranties The Company provides a one-year Company may be refurbished and redeployed. Estimated warranty costs are recorded at the time of shipment of the OCS Console or disposable set. Warranty costs are estimated based on the current expected product replacement or repair cost and expected replacement or repair rates based on historical experience. The Company evaluates its warranty accrual at the end of each reporting period and makes adjustments as necessary. As of December 31, 202 1 and 2020 , the warranty accrual was less than $0.1 million. |
Revenue Recognition | Revenue Recognition The Company generates revenue primarily from sales of its single-use, organ-specific disposable sets (i.e., its organ-specific OCS Perfusion Sets sold together with its organ-specific OCS Solutions) used on its organ-specific OCS Consoles, each being a component of the Company’s OCS products. To a lesser extent, the Company also generates revenue from the sale of OCS Consoles to customers and from the implied rental of OCS Consoles loaned to customers at no charge. For each new transplant procedure, customers purchase an additional OCS disposable set for use on the customer’s existing organ-specific OCS Console. The Company recognizes revenue from sales to customers applying the following five steps: (1) identification of the contract, or contracts, with a customer, (2) identification of the performance obligations in the contract, (3) determination of the transaction price, (4) allocation of the transaction price to the performance obligations in the contract, and (5) recognition of revenue when, or as, performance obligations are satisfied. Substantially all of the Company’s customer contracts have multiple-performance obligations that contain deliverables consisting of OCS Perfusion Sets and OCS Solutions. In some of those customer contracts, the deliverables also include an OCS Console, whether sold or loaned to the customer. The Company evaluates each promise within a multiple-performance obligation arrangement to determine whether it represents a distinct performance obligation. The primary performance obligations in the Company’s customer arrangements from which it derives revenue are the OCS Perfusion Sets, the OCS Solutions and the OCS Console. Revenue for each OCS Perfusion Set and OCS Solutions is recognized at the point in time at which control is transferred to the customer, which is when title transfers to the customer, typically upon arrival at the customer site. When a customer order includes an OCS Console, the Company has determined that customer training and the equipment set-up of the OCS Console, each performed by the Company, are not distinct because they are not sold on a standalone basis and can only be performed by the Company in conjunction with a sale or loan of its OCS Console. In addition, the Company has determined that the OCS Console itself is not distinct because the customer cannot benefit from the OCS Console without the training and equipment set-up having been completed. As a result, when the order includes an OCS Console, the Company has concluded that training, OCS Console equipment set-up, and the OCS Console itself are highly interdependent and represent a single, combined performance obligation. The Company recognizes revenue from the single, combined performance obligation only once the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by the Company. Customer orders may include the loan of an OCS Console as well as OCS disposable sets. When the Company loans the OCS Console to the customer, it retains title to the console at all times and does not require minimum purchase commitments from the customer related to any OCS products. In such cases, the Company invoices the customer for OCS disposable sets based on customer orders received and the prices set forth in the customer agreement. Over time, the Company typically recovers the cost of the loaned OCS Console through the customer’s continued purchasing of OCS disposable sets. For these reasons, the Company has determined that part of the arrangement consideration for the disposable set is an implied rental payment for use of the OCS Console. Therefore, the Company allocates the arrangement consideration between the lease deliverables (i.e., the OCS Console) and non-lease deliverables (i.e., the OCS disposable sets) based on the relative estimated standalone selling price of each distinct performance obligation. To date, the amounts allocated to lease deliverables have been insignificant. Because all performance obligations of a customer order are delivered and recognized as revenue at the same time and because revenue allocated to performance obligations other than OCS disposable sets, such as implied rental income and service revenue, is insignificant, all components of revenue from customer arrangements are classified as a single category of revenue in the Company’s consolidated statements of operations. Revenue is recognized when control of the OCS product or products is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for the product or products. Payments Made to Customers Under the Company’s customer arrangements that include a customer clinical trial agreement, the Company makes payments to that customer for reimbursements of clinical trial costs, materials, and for specified clinical documentation related to the customer’s use of its OCS products. The Company also makes payments to customers involved in post-approval studies for information related to the transplant procedures performed. The Company determines the appropriate accounting treatments for these payments depending on the nature of the payment and whether they are for distinct goods or services. 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 December 31, 2021 and 2020 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. The Company generally satisfies performance obligations within one year of the contract inception date. As of December 31, 2021 Other Revenue Considerations Revenue is reported net of taxes. The Company does not consider shipping to be a contract performance obligation, therefore shipping costs incurred and billed to customers are recorded as revenue and cost of revenue. The Company only includes estimated variable amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. The Company does not assess whether promised goods or services are performance obligations if they are deemed immaterial in the context of the contract with the customer. Additionally, the Company does not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. Distributors The Company markets and sells its products primarily through its direct sales force, which sells its products to end customers globally. A small portion of the Company’s revenue is generated by sales to a limited number of distributors in Europe and Asia-Pacific. When the Company transacts with a distributor, its contractual arrangement is with the distributor and not with the end customer. Whether the Company transacts business with and receives the order from a distributor or directly from an end customer, its revenue recognition policy and resulting pattern of revenue recognition for the order are the same. |
Research, Development and Clinical Trials Costs | Research, Development and Clinical Trials Costs Research, development and clinical trials expenses consist of costs incurred for research activities, product development, hardware and software engineering and clinical trial activities, including salaries and bonuses, stock-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation, testing, regulatory, data management and consulting costs. Research, development and clinical trials costs are expensed as incurred. Advance payments for goods or services to be received in the future for use in research, development and clinical trials activities are recorded as prepaid expenses. Such prepaid expenses are recognized as an expense when the related goods have been delivered or the related services have been performed, or when it is no longer expected that the goods will be delivered or the services rendered. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of each of the Company’s foreign subsidiaries is the currency of the local country. Assets and liabilities of the Company’s foreign subsidiaries are translated into U.S. dollars using the period-end exchange rates, and income and expense items are translated into U.S. dollars using average exchange rates in effect during each period. The effects of these foreign currency translation adjustments are included in accumulated other comprehensive loss, a separate component of stockholders’ equity. The Company also incurs transaction gains and losses resulting from intercompany transactions as well as transactions with customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded. Realized and unrealized foreign currency transaction gains (losses) are included in the consolidated statements of operations as a component of other income (expense) and totaled ($1.0) million and $1.0 million for the years ended December 31, 2021 and 2020, respectively. |
Stock-based Compensation | Stock-Based Compensation The Company measures stock-based option awards granted to employees, non-employees and directors based on their fair value on the date of grant using the Black-Scholes option-pricing model. Generally, the Company issues awards with only service-based vesting conditions. Compensation expense for those awards is recognized over the vesting period of the respective award using the straight-line method. The Company accounts for forfeitures as they occur and records compensation cost assuming all option holders will complete the requisite service period. When the unvested portion of an award is forfeited, the Company reverses compensation expense previously recognized in the period of the forfeiture. The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. |
Comprehensive Loss and Accumulated Other Comprehensive Loss | Comprehensive Loss and Accumulated Other Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only elements of other comprehensive loss are foreign currency translation adjustments and unrealized gains (losses) on marketable securities. Accumulated other comprehensive gains (losses) on the consolidated balance sheets consists primarily of foreign currency translation adjustments. Accumulated other comprehensive loss attributable to unrealized losses on marketable securities has not been significant. |
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 years ended December 31, 2021 and 2020. 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 December 31, 2021 2020 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 2,797,550 2,261,234 Employee stock purchase plan 12,465 14,951 2,874,455 2,340,625 |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company's tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be realized and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by analyzing carryback capacity in periods with taxable income, reversal of existing taxable temporary differences and estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company adopted ASU No. 2016-02, Leases (Topic 842), inclusive of ASU 2021-05 Leases (Topic 842): Lessors – Certain Leases with Variable Lease Payments, effective January 1, 2021, using the modified retrospective method under ASU No. 2018-11, Leases (Topic 842): Targeted Improvements. Since the Company ceased to be an emerging growth company as of December 31, 2021, the Company adopted the standard during the fourth quarter of 2021 effective as of January 1, 2021. The modified retrospective transition method allows entities to apply the transition requirements at the effective date rather than at the beginning of the earliest comparative period presented. The Company’s reporting for comparative periods was not recast and is presented in accordance with ASC 840. Adoption of the new standard resulted in the recording of right-of-use assets and lease liabilities of $6.7 million and $8.4 million, respectively. The adoption of the standard did not have a material impact on the Company’s results of operations or cash flows. The Company elected to use the transition package of three practical expedients, which among other things, allowed the Company to carry forward the historical lease classification. The Company has also elected to use its incremental borrowing rate on the date of adoption using the remaining lease term as of the date of adoption. The underlying assets of the Company’s leases as of the adoption date consisted of office, laboratory and manufacturing space. The Company assessed the implied rentals of OCS consoles loaned to customers at no charge. In accordance with ASC 842, lessors should classify and account for a lease with variable lease payments that do not depend on a reference index or a rate as an operating lease if the lease would have been classified as a sales-type lease or a direct financing lease and the lessor would have otherwise recognized a day-one loss. The Company’s implied rentals of OCS consoles meet such criteria to continue to account for the lease as an operating lease as the lease would have been classified as a sales-type lease and a day-one loss would have otherwise been recognized. Therefore, the adoption of the standard had no impact on the consolidated financial statements and related disclosures in accordance with ASU 2021-05 Leases (Topic 842): Lessors – Certain Leases with Variable Lease Payments. The Company adopted ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments for the year ended December 31, 2021. The new standard adjusts the accounting for assets held at amortized costs basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. The adoption of this standard did not have a material impact on the consolidated financial statements and related disclosures. The Company adopted ASU No. 2019-12 , Income Taxes – Simplifying the Accounting for Income Taxes (Topic 740) for the year ended December 31, 2021. The amendments in this update simplify the accounting for income taxes by removing certain exceptions to the general principles as well as clarifying and amending existing guidance to improve consistent application. The adoption of this standard did not have a material impact on the consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life of Assets | Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Estimated Useful Life Manufacturing equipment 5 years OCS Consoles loaned to customers 5 years Computer equipment and software 3 years Laboratory equipment 3 years Office and trade show equipment 5 years Leasehold improvements Shorter of term of lease or 15 years |
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 December 31, 2021 2020 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 2,797,550 2,261,234 Employee stock purchase plan 12,465 14,951 2,874,455 2,340,625 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Components of Marketable Securities by Security Type | Marketable securities by security type consisted of the following (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized 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 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Treasury securities (due within one year) $ 74,066 $ 10 $ (3 ) $ 74,073 U.S. government agency bonds (due within one year) 26,984 4 — 26,988 $ 101,050 $ 14 $ (3 ) $ 101,061 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets that are measured at fair value on a recurring basis (in thousands): 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 Fair Value Measurements at December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 13,829 $ — $ — $ 13,829 Marketable securities: U.S. Treasury securities — 74,073 — 74,073 U.S. government agency bonds — 26,988 — 26,988 $ 13,829 $ 101,061 $ — $ 114,890 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consisted of the following (in thousands): December 31, 2021 2020 Raw materials $ 7,274 $ 6,770 Work-in-process 1,932 1,102 Finished goods 5,653 4,062 $ 14,859 $ 11,934 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Manufacturing equipment $ 1,769 $ 1,725 OCS Consoles loaned to customers 8,865 7,196 Computer equipment and software 1,511 1,338 Laboratory equipment 668 617 Office and trade show equipment 177 177 Leasehold improvements 1,319 1,319 Construction-in-progress 5,267 409 19,576 12,781 Less: Accumulated depreciation and amortization (9,735 ) (8,027 ) $ 9,841 $ 4,754 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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): December 31, 2021 2020 Accrued research, development and clinical trial expenses $ 4,567 $ 4,426 Accrued payroll and related expenses 5,173 4,030 Accrued professional fees 1,973 344 Accrued other 4,624 1,610 $ 16,337 $ 10,410 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-term debt consisted of the following (in thousands): December 31, 2021 2020 Principal amount of long-term debt $ 35,000 $ 35,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 35,000 35,000 Debt discount, net of accretion (511 ) (834 ) Accrued end-of-term payments 708 491 Long-term debt, net of discount and current portion $ 35,197 $ 34,657 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Assumptions Used to Determine Grant Date Fair Value of Stock Options Granted | The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of stock options granted to employees and directors: Year Ended December 31, 2021 2020 Risk-free interest rate 0.90 % 0.91 % Expected term (in years) 6.03 5.97 Expected volatility 58 % 54 % Expected dividend yield 0 % 0 % |
Summary of Stock Option Activity | The following table summarizes the Company’s option activity since December 31, 2020: Number of Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (in years) (in thousands) Outstanding as of December 31, 2020 2,261,234 $ 8.17 6.22 $ 26,671 Granted 1,326,675 34.60 Exercised (588,461 ) 1.65 Forfeited (200,060 ) 28.10 Expired (1,838 ) 31.76 Outstanding as of December 31, 2021 2,797,550 $ 20.64 7.54 $ 14,625 Vested and expected to vest as of December 31, 2021 2,797,550 $ 20.64 7.54 $ 14,625 Options exercisable as of December 31, 2021 1,371,048 $ 11.80 6.11 $ 13,143 |
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): Year Ended December 31, 2021 2020 Cost of revenue $ 72 $ 27 Research, development and clinical trials expenses 1,114 396 Selling, general and administrative expenses 5,692 1,991 $ 6,878 $ 2,414 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Income Before Taxes The domestic and foreign components of loss before income taxes were as follows (in thousands): Year Ended December 31, 2021 2020 United States $ (44,321 ) $ (28,803 ) Foreign 142 87 $ (44,179 ) $ (28,716 ) |
Reconciliation of U.S. Federal Statutory Income Tax Rate to Company's Effective Income Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate (21.0 )% (21.0 )% State taxes, net of federal benefit (6.9 )% (5.7 )% Federal and state research and development tax credits (2.4 )% (3.6 )% Nondeductible items (3.2 )% (0.2 )% Deferred tax effect of change in state blended rate (1.7 )% 7.8 % Return to provision 1.1 % 1.7 % Other (0.2 )% 0.0 % Change in deferred tax asset valuation allowance 34.3 % 20.9 % Effective income tax rate 0.0 % (0.1 )% |
Schedule of Net deferred Tax Assets | Net deferred tax assets consisted of the following (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 94,672 $ 81,390 Capitalized research and development expense 4,291 6,136 Research and development tax credit carryforwards 12,186 11,541 Accrued expenses 2,528 1,390 Stock-based compensation expense 2,254 791 Deferred rent — 79 Lease liability 2,299 — Other 170 132 Total deferred tax assets 118,400 101,459 Deferred tax liabilities: Other (674 ) (218 ) Right-of-use assets (1,562 ) — Unrealized gain (loss) — (212 ) Total deferred tax liabilities (2,236 ) (430 ) Valuation allowance (116,164 ) (101,029 ) Net deferred tax assets $ — $ — |
Summary Changes in the Valuation Allowance for Deferred Tax Assets | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021 and 2020 related primarily to the increase in net operating loss carryforwards and research and development tax credit carryforwards in 2021 and 2020, and were as follows (in thousands): Year Ended December 31, 2021 2020 Valuation allowance as of beginning of year $ (101,029 ) $ (95,024 ) Decreases recorded as benefit to income tax provision — — Increases recorded to income tax provision (15,135 ) (6,005 ) Valuation allowance as of end of year $ (116,164 ) $ (101,029 ) |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Summary of Components of Lease Expense | The components of the Company’s lease expense under ASC 842 are as follows: Year Ended December 31, 2021 Operating lease cost $ 1,353 Short-term lease cost 159 Variable lease cost 640 $ 2,152 |
Summary of Supplemental Disclosure of Cash Flow Information Related to Leases | Supplemental disclosure of cash flow information related to the leases were as follows (in thousands): Year Ended December 31, 2021 Cash paid for amounts included in the measurement of operating lease liabilities $ 1,901 Operating lease liabilities arising from obtaining right-of-use assets and leasehold improvements $ — |
Summary of Future Annual Lease Payments | Future annual lease payments under the Company’s Leases as of December 31, 2021 are as follows (in thousands): Year Ending December 31, 2022 $ 1,948 2023 1,997 2024 2,047 2025 2,098 2026 2,150 Thereafter 2,204 Total future minimum lease payments 12,444 Less: imputed interest (2,273 ) Less: estimated lease incentives (1,567 ) Total operating lease liabilities $ 8,604 |
Summary of Lease Liabilities on Consolidated Balance Sheet | The following table represents lease liabilities on the consolidated balance sheet (in thousands): December 31, 2021 Current operating lease liabilities $ — Operating lease liabilities, net of current portion 8,604 Total operating lease liabilities $ 8,604 |
Summary of Minimum Lease Payments under Operating Leases under Prior Lease Guidance | Under prior lease guidance, minimum lease payments under operating leases were as follows as December 31, 2020 (in thousands): Year Ending December 31, 2021 $ 1,900 2022 1,948 2023 1,997 2024 2,047 2025 2,098 Thereafter 4,354 $ 14,344 |
Segment Reporting and Geograp_2
Segment Reporting and Geographic Data (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Schedule of Financial Data by Geographical Area | Financial data by geographical area is summarized as follows (in thousands): Year Ended December 31, 2021 2020 Net revenue by country: United States $ 21,861 $ 19,239 All other countries 8,401 6,400 Total net revenue $ 30,262 $ 25,639 |
Long-lived Assets by Country | December 31, 2021 2020 Long-lived assets by country(1): United States $ 9,085 $ 4,114 All other countries 756 640 Total long-lived assets $ 9,841 $ 4,754 (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) | 12 Months Ended |
Dec. 31, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Schedule of Recognized Revenue Net of Payments | The reconciliation of gross revenue to net revenue for these certain payments is shown below (in thousands): Year Ended December 31, 2021 2020 Gross revenue from sales to customers $ 31,385 $ 28,356 Less: Clinical trial payments reducing revenue 1,123 2,717 Total net revenue $ 30,262 $ 25,639 |
Schedule of Net Revenue by OCS Product and Country | 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): Year Ended December 31, 2021 2020 Net revenue by OCS product: OCS Lung net revenue $ 10,665 $ 6,194 OCS Heart net revenue 17,683 14,196 OCS Liver net revenue 1,914 5,249 Total net revenue $ 30,262 $ 25,639 Year Ended December 31, 2021 2020 Net revenue by country (1): United States $ 21,861 $ 19,239 All other countries 8,401 6,400 Total net revenue $ 30,262 $ 25,639 (1) Net revenue by country is categorized based on the location of the end customer |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Net loss | $ 44,215 | $ 28,748 |
Accumulated deficit | 442,446 | $ 398,231 |
Cash equivalents and marketable securities | $ 92,500 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2021USD ($)LetterSegment | Dec. 31, 2020USD ($)Letter | Dec. 28, 2019USD ($) | |
Letters of credit outstanding | $ 500,000 | $ 500,000 | |
Number of letters of credit maintained | Letter | 2 | 2 | |
Restricted cash non-current | $ 500,000 | $ 500,000 | |
Cash, cash equivalents and restricted cash | 26,080,000 | 25,081,000 | $ 20,592,000 |
Allowance for credit losses | 0 | 0 | |
Provisions for credit losses | 0 | 0 | |
Write off accounts receivable balances | 0 | 0 | |
Impairment losses on long-lived assets | 0 | 0 | |
Capitalized software development costs | 0 | 0 | |
Provision for loss on contracts | 0 | ||
Credit losses | $ 0 | 0 | |
Number of operating segments | Segment | 1 | ||
Term of product warranties | 1 year | ||
Product warranty description | The Company provides a one-year warranty on its OCS Consoles and disposable sets and replaces or repairs any OCS Console or disposable set that does not function in accordance with the product specifications | ||
Contract with customer, asset, after allowance for credit loss | $ 0 | 0 | |
Performance obligations totaled | 1,400,000 | ||
Operating lease right-of-use assets | 5,847,000 | ||
Lease liabilities | 8,604,000 | ||
ASU No. 2016-02 | |||
Operating lease right-of-use assets | 6,700,000 | ||
Lease liabilities | $ 8,400,000 | ||
Change in accounting principle, accounting standards update, adopted | true | ||
Change in accounting principle, accounting standards update, immaterial effect | true | ||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | ||
ASU No. 2016-13 | |||
Change in accounting principle, accounting standards update, adopted | true | ||
Change in accounting principle, accounting standards update, immaterial effect | true | ||
ASU No. 2019-12 | |||
Change in accounting principle, accounting standards update, adopted | true | ||
Change in accounting principle, accounting standards update, immaterial effect | true | ||
Other Income (Expense) [Member] | |||
Foreign currency transaction gains (losses) | $ (1,000,000) | 1,000,000 | |
Maximum [Member] | |||
Product warranty accrual | $ 100,000 | $ 100,000 | |
Performance obligations satisfaction period | 1 year | ||
Customer Concentration Risk [Member] | Revenue [Member] | Significant Customer Benchmark [Member] | Minimum [Member] | |||
Concentration risk percentage | 10.00% | ||
Customer Concentration Risk [Member] | Revenue [Member] | Customer One [Member] | |||
Concentration risk percentage | 11.00% | 14.00% | |
Customer Concentration Risk [Member] | Revenue [Member] | Customer Two [Member] | |||
Concentration risk percentage | 10.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Significant Customer Benchmark [Member] | Minimum [Member] | |||
Concentration risk percentage | 10.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Customer One [Member] | |||
Concentration risk percentage | 21.00% | 30.00% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Customer Two [Member] | |||
Concentration risk percentage | 15.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Life of Assets (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Manufacturing Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | 5 years |
OCS Consoles Loaned to Customers [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Computer Equipment and Software [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Laboratory Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Office and Trade Show Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Leasehold Improvements [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Life | Shorter of term of lease or 15 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Warrants to purchase common stock | 2,874,455 | 2,340,625 |
Warrants to purchase common stock | ||
Warrants to purchase common stock | 64,440 | 64,440 |
Options to purchase common stock | ||
Warrants to purchase common stock | 2,797,550 | 2,261,234 |
Employee stock purchase plan | ||
Warrants to purchase common stock | 12,465 | 14,951 |
Marketable Securities - Compone
Marketable Securities - Components of Marketable Securities by Security Type (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable Securities, Amortized Cost | $ 66,908 | $ 101,050 |
Marketable Securities, Gross Unrealized Gains | 14 | |
Marketable Securities, Gross Unrealized Losses | (36) | (3) |
Marketable Securities, Fair Value | 66,872 | 101,061 |
U.S. Treasury Securities (due within one year) [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable Securities, Amortized Cost | 63,907 | 74,066 |
Marketable Securities, Gross Unrealized Gains | 10 | |
Marketable Securities, Gross Unrealized Losses | (33) | (3) |
Marketable Securities, Fair Value | 63,874 | 74,073 |
U.S. Government Agency Bonds (due within one year) [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Marketable Securities, Amortized Cost | 3,001 | 26,984 |
Marketable Securities, Gross Unrealized Gains | 4 | |
Marketable Securities, Gross Unrealized Losses | (3) | |
Marketable Securities, Fair Value | $ 2,998 | $ 26,988 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets - Fair Value of Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable securities: | ||
Marketable securities | $ 66,872 | $ 101,061 |
Cash equivalents and marketable securities | 78,041 | 114,890 |
U.S. Treasury Securities (due within one year) [Member] | ||
Marketable securities: | ||
Marketable securities | 63,874 | 74,073 |
U.S. Government Agency Bonds (due within one year) [Member] | ||
Marketable securities: | ||
Marketable securities | 2,998 | 26,988 |
Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 11,169 | 13,829 |
Level 1 [Member] | ||
Marketable securities: | ||
Cash equivalents and marketable securities | 11,169 | 13,829 |
Level 1 [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 11,169 | 13,829 |
Level 2 [Member] | ||
Marketable securities: | ||
Cash equivalents and marketable securities | 66,872 | 101,061 |
Level 2 [Member] | U.S. Treasury Securities (due within one year) [Member] | ||
Marketable securities: | ||
Marketable securities | 63,874 | 74,073 |
Level 2 [Member] | U.S. Government Agency Bonds (due within one year) [Member] | ||
Marketable securities: | ||
Marketable securities | $ 2,998 | $ 26,988 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 7,274 | $ 6,770 |
Work-in-process | 1,932 | 1,102 |
Finished goods | 5,653 | 4,062 |
Inventory, net | $ 14,859 | $ 11,934 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | ||
Inventory transfer to property plant and equipment | $ 1,823 | $ 1,191 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 19,576 | $ 12,781 |
Less: Accumulated depreciation and amortization | (9,735) | (8,027) |
Property and equipment, net | 9,841 | 4,754 |
Manufacturing Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,769 | 1,725 |
OCS Consoles Loaned To Customers [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 8,865 | 7,196 |
Computer Equipment and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,511 | 1,338 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 668 | 617 |
Office and Trade Show Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 177 | 177 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,319 | 1,319 |
Construction-In-Progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 5,267 | $ 409 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property Plant And Equipment [Line Items] | ||
Depreciation and amortization expense | $ 1,817 | $ 1,577 |
OCS Consoles Loaned To Customers [Member] | Cost of Revenue [Member] | ||
Property Plant And Equipment [Line Items] | ||
Depreciation | $ 1,400 | $ 1,300 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses And Other Current Liabilities [Abstract] | ||
Accrued research, development and clinical trial expenses | $ 4,567 | $ 4,426 |
Accrued payroll and related expenses | 5,173 | 4,030 |
Accrued professional fees | 1,973 | 344 |
Accrued other | 4,624 | 1,610 |
Accrued expenses and other liabilities current | $ 16,337 | $ 10,410 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | Apr. 20, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 29, 2018 |
Long-term Debt, Gross | $ 35,000 | $ 35,000 | ||
Orbi Med [Member] | ||||
Long-term Debt, Gross | $ 35,000 | |||
Description of variable rate basis | London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0% and a maximum of 4.0% | |||
Basis spread on variable rate | 8.50% | |||
Interest rate effective percentage | 9.50% | 9.50% | ||
Final payment | 3.00% | |||
Description of covenants | The financial covenants include maintaining a minimum liquidity amount of $3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from the Company’s independent registered public accounting firm; and restrictions on the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. | |||
Minimum liquidity covenant amount | $ 3,000 | |||
Average effective interest rate | 11.20% | 11.20% | ||
Orbi Med [Member] | In Event Of Default [Member] | ||||
Increasing applicable margin | 4.00% | |||
Orbi Med [Member] | Credit Agreement [Member] | ||||
Debt Instrument Maturity Month And Year | 2023-06 | |||
Orbi Med [Member] | Minimum [Member] | ||||
Paid in kind interest threshold | 11.50% | |||
Orbi Med [Member] | Maximum [Member] | ||||
Interest rate effective percentage | 11.50% | |||
Paid in kind interest threshold | 12.50% | |||
Orbi Med [Member] | London Interbank Offered Rate (LIBOR) | Minimum [Member] | ||||
LIBOR Rate | 1.00% | |||
Orbi Med [Member] | London Interbank Offered Rate (LIBOR) | Maximum [Member] | ||||
LIBOR Rate | 4.00% | |||
Bankof America [Member] | Promissory Note [Member] | Paycheck Protection Program [Member] | ||||
Loan proceeds | $ 2,200 | |||
Fixed interest rate | 1.00% | |||
Repayment date | May 1, 2020 | |||
Maturity date | Apr. 20, 2022 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Long-term Debt, Gross | $ 35,000 | $ 35,000 |
Long-term debt, net of current portion | 35,000 | 35,000 |
Debt discount, net of accretion | (511) | (834) |
Accrued end-of-term payments | 708 | 491 |
Long-term debt, net of discount and current portion | $ 35,197 | $ 34,657 |
Equity - Additional Information
Equity - Additional Information (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | May 06, 2019 | |
Class Of Stock [Line Items] | |||
Preferred stock, shares authorized | 25,000,000 | 25,000,000 | |
Preferred stock, no par value | |||
Common stock, shares authorized | 150,000,000 | 150,000,000 | |
Common stock, no par value | |||
Common stock, voting rights | Each share of common stock is entitled to one vote on all matters submitted to a vote of the Company’s stockholders. | ||
Common stock, dividends, declared | $ 0 | ||
Common stock, dividends, paid | $ 0 | ||
Exercise Price of $8.75 Per Share [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock warrants shares issued upon conversion | 50,000 | ||
Preferred stock warrants convertible conversion price | $ 8.75 | ||
Class of warrant or rights expiration date | Nov. 7, 2022 | ||
Exercise Price of $17.47 Per Share [Member] | |||
Class Of Stock [Line Items] | |||
Preferred stock warrants shares issued upon conversion | 14,440 | ||
Preferred stock warrants convertible conversion price | $ 17.47 | ||
Class of warrant or rights expiration date | May 6, 2024 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Apr. 15, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2021 |
Aggregate intrinsic value of stock options exercised | $ 16.3 | $ 2.9 | ||
Weighted average grant-date fair value of stock options granted | $ 18.63 | $ 7.91 | ||
Unrecognized compensation cost related to unvested employee and director stock-based awards | $ 20.9 | |||
Weighted average period for unrecognized compensation cost | 2 years 8 months 12 days | |||
Performance-based Vesting [Member] | ||||
Shares granted to employees | 0 | |||
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 | 1,583,925 | |||
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 | 320,596 | |||
Purchase price of common stock, percent | 85.00% | |||
Number of shares issued | 27,849 | |||
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 | 738,700 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used to Determine Grant Date Fair Value of Stock Options Granted (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders Equity Note [Abstract] | ||
Risk-free interest rate | 0.90% | 0.91% |
Expected term (in years) | 6 years 10 days | 5 years 11 months 19 days |
Expected volatility | 58.00% | 54.00% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Number of Shares | ||
Beginning Balance | shares | 2,261,234 | |
Granted | shares | 1,326,675 | |
Exercised | shares | (588,461) | |
Forfeited | shares | (200,060) | |
Expired | shares | (1,838) | |
Ending Balance | shares | 2,797,550 | 2,261,234 |
Vested and expected to vest as of December 31, 2021 | shares | 2,797,550 | |
Options exercisable as of December 31, 2021 | shares | 1,371,048 | |
Weighted Average Exercise Price | ||
Beginning Balance | $ / shares | $ 8.17 | |
Granted | $ / shares | 34.60 | |
Exercised | $ / shares | 1.65 | |
Forfeited | $ / shares | 28.10 | |
Expired | $ / shares | 31.76 | |
Ending Balance | $ / shares | 20.64 | $ 8.17 |
Vested and expected to vest as of December 31, 2021 | $ / shares | 20.64 | |
Options exercisable as of December 31, 2021 | $ / shares | $ 11.80 | |
Weighted Average Contractual Term | ||
Options Outstanding | 7 years 6 months 14 days | 6 years 2 months 19 days |
Vested and expected to vest as of December 31, 2021 | 7 years 6 months 14 days | |
Options exercisable as of December 31, 2021 | 6 years 1 month 9 days | |
Aggregate Intrinsic Value | ||
Options Outstanding | $ | $ 14,625 | $ 26,671 |
Vested and expected to vest as of December 31, 2021 | $ | 14,625 | |
Options exercisable as of December 31, 2021 | $ | $ 13,143 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Allocated Share-based Compensation Expense | $ 6,878 | $ 2,414 |
Cost of revenue [Member] | ||
Allocated Share-based Compensation Expense | 72 | 27 |
Research, development and clinical trials expenses [Member] | ||
Allocated Share-based Compensation Expense | 1,114 | 396 |
Selling, general and administrative expenses [Member] | ||
Allocated Share-based Compensation Expense | $ 5,692 | $ 1,991 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 28, 2019 | |
Income Taxes [Line Items] | |||
Operating loss carryforwards, limitations on use | These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income or tax liabilities. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. | ||
Valuation allowance | $ 116,164,000 | $ 101,029,000 | $ 95,024,000 |
Increase in valuation allowance | 15,100,000 | ||
Unrecognized tax benefits | 0 | 0 | |
Unrecognized tax benefits, related interest and penalties accrued | 0 | 0 | |
Accrued interest or penalties related to uncertain tax positions | $ 0 | 0 | |
Earliest Tax Year [Member] | |||
Income Taxes [Line Items] | |||
Open Tax Year | 2018 | ||
U.S. Federal [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 368,100,000 | ||
Operating loss carryforwards begin to expire | 2022 | ||
State [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 304,000,000 | ||
Operating loss carryforwards begin to expire | 2030 | ||
Foreign [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 0 | ||
Research and Development Tax Credits [Member] | |||
Income Taxes [Line Items] | |||
Income tax benefits | 0 | 0 | |
Research and Development Tax Credits [Member] | U.S. Federal [Member] | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 8,000,000 | ||
Tax credits carryforwards begin to expire | 2022 | ||
Research and Development Tax Credits [Member] | State [Member] | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 5,300,000 | ||
Tax credits carryforwards begin to expire | 2024 | ||
Non-expirable [member] | U.S. Federal [Member] | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards | $ 156,400,000 | ||
Net Operating Loss [Member] | |||
Income Taxes [Line Items] | |||
Income tax benefits | 0 | 0 | |
Maximum [Member] | |||
Income Taxes [Line Items] | |||
Foreign income tax provision | $ 100,000 | $ 100,000 |
Income Taxes - Schedule of Loss
Income Taxes - Schedule of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (44,321) | $ (28,803) |
Foreign | 142 | 87 |
Loss before income taxes | $ (44,179) | $ (28,716) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Federal Statutory Income Tax Rate to Company's Effective Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | (21.00%) | (21.00%) |
State taxes, net of federal benefit | (6.90%) | (5.70%) |
Federal and state research and development tax credits | (2.40%) | (3.60%) |
Nondeductible items | (3.20%) | (0.20%) |
Deferred tax effect of change in state blended rate | (1.70%) | 7.80% |
Return to provision | 1.10% | 1.70% |
Other | (0.20%) | (0.00%) |
Change in deferred tax asset valuation allowance | 34.30% | 20.90% |
Effective income tax rate | (0.00%) | (0.10%) |
Income Taxes - Schedule of Net
Income Taxes - Schedule of Net deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 28, 2019 |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 94,672 | $ 81,390 | |
Capitalized research and development expense | 4,291 | 6,136 | |
Research and development tax credit carryforwards | 12,186 | 11,541 | |
Accrued expenses | 2,528 | 1,390 | |
Stock-based compensation expense | 2,254 | 791 | |
Deferred rent | 79 | ||
Lease liability | 2,299 | ||
Other | 170 | 132 | |
Total deferred tax assets | 118,400 | 101,459 | |
Deferred tax liabilities: | |||
Other | (674) | (218) | |
Right-of-use assets | (1,562) | ||
Unrealized gain (loss) | (212) | ||
Total deferred tax liabilities | (2,236) | (430) | |
Valuation allowance | $ (116,164) | $ (101,029) | $ (95,024) |
Income Taxes - Summary of Chang
Income Taxes - Summary of Changes in the Valuation Allowance for Deferred Tax Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Valuation allowance as of beginning of year | $ (101,029) | $ (95,024) |
Increases recorded to income tax provision | (15,135) | (6,005) |
Valuation allowance as of end of year | $ (116,164) | $ (101,029) |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Leases [Abstract] | |
Lease expiration month and year | Dec. 31, 2027 |
Lessee, operating lease, existence of option to extend [true false] | true |
Lessee operating lease description | that expire in December 2027 and include a lease incentive, fixed payment escalations, and rent holidays. The Leases include an option to renew for an additional five years. |
Lessee, operating lease, renewal term | 5 years |
Lease base rent annual increase | 2.50% |
Leasehold improvements landlord allowance | $ 3.4 |
Lease incentive | $ 3.4 |
Operating lease, weighted-average remaining lease term | 6 years |
Operating lease, weighted-average discount rate | 6.70% |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Leases [Abstract] | |
Operating lease cost | $ 1,353 |
Short-term lease cost | 159 |
Variable lease cost | 640 |
Lease expense | $ 2,152 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Disclosure of Cash Flow Information Related To Leases (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Leases [Abstract] | |
Cash paid for amounts included in the measurement of operating lease liabilities | $ 1,901 |
Leases - Summary of Future Annu
Leases - Summary of Future Annual Lease Payments (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 1,948 |
2023 | 1,997 |
2024 | 2,047 |
2025 | 2,098 |
2026 | 2,150 |
Thereafter | 2,204 |
Total future minimum lease payments | 12,444 |
Less: imputed interest | (2,273) |
Less: estimated lease incentives | (1,567) |
Lease liabilities | $ 8,604 |
Leases - Summary of Lease Liabi
Leases - Summary of Lease Liabilities on Consolidated Balance Sheet (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
Operating lease liabilities, net of current portion | $ 8,604 |
Total operating lease liabilities | $ 8,604 |
Leases - Summary of Minimum Lea
Leases - Summary of Minimum Lease Payments under Operating Leases under Prior Lease Guidance (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Leases [Abstract] | |
2021 | $ 1,900 |
2022 | 1,948 |
2023 | 1,997 |
2024 | 2,047 |
2025 | 2,098 |
Thereafter | 4,354 |
Future minimum payments due | $ 14,344 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Payments for royalties | $ 0.4 | $ 0.3 | |
Royalty payable | 0.2 | 0.1 | |
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 | 8 | ||
Maximum [Member] | |||
Guaranteed minimum annual royalty payment | $ 0.1 |
Segment Reporting and Geograp_3
Segment Reporting and Geographic Data - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2021Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment Reporting and Geograp_4
Segment Reporting and Geographic Data - Schedule of Financial Data by Geographical Area (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Net revenue by country: | |||
Total net revenue | [1] | $ 30,262 | $ 25,639 |
United States [Member] | |||
Net revenue by country: | |||
Total net revenue | [1] | 21,861 | 19,239 |
All Other Countries [Member] | |||
Net revenue by country: | |||
Total net revenue | $ 8,401 | $ 6,400 | |
[1] | Net revenue by country is categorized based on the location of the end customer |
Segment Reporting and Geograp_5
Segment Reporting and Geographic Data - Long-lived Assets by Country (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 9,841 | $ 4,754 |
United States [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | 9,085 | 4,114 |
All Other Countries [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 756 | $ 640 |
[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 - Schedule of Recognize
Revenue - Schedule of Recognized Revenue Net of Payments (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Revenue From Contract With Customer [Abstract] | |||
Gross revenue from sales to customers | $ 31,385 | $ 28,356 | |
Less: Clinical trial payments reducing revenue | 1,123 | 2,717 | |
Total net revenue | [1] | $ 30,262 | $ 25,639 |
[1] | Net revenue by country is categorized based on the location of the end customer |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | ||
Research development and clinical trials expenses | $ 2.1 | $ 1.6 |
Revenue - Schedule of Net Reven
Revenue - Schedule of Net Revenue by OCS Product and Country (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | ||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | [1] | $ 30,262 | $ 25,639 |
United States [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | [1] | 21,861 | 19,239 |
All Other Countries [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | [1] | 8,401 | 6,400 |
OCS Lung net revenue [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | 10,665 | 6,194 | |
OCS Heart net revenue [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | 17,683 | 14,196 | |
OCS Liver net revenue [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Net revenue | $ 1,914 | $ 5,249 | |
[1] | Net revenue by country is categorized based on the location of the end customer |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Director [Member] | ||
Compensation Expense | $ 0.4 | $ 0.3 |