0001564590-22-027757 | 10-Q | XBRL Viewer

Research, development and clinical trials

^[1]

$ 20,521

$ 8,171

$ 36,401

$ 15,224

Cost of revenue

6,171

2,582

9,947

4,824

Gross profit

14,350

5,589

26,454

10,400

Operating expenses:

6,714

6,295

14,248

10,827

Selling, general and administrative

17,381

9,162

31,320

15,948

Total operating expenses

24,095

15,457

45,568

26,775

Loss from operations

(9,745)

(9,868)

(19,114)

(16,375)

Other income (expense):

Interest expense

(972)

(965)

(1,932)

(1,917)

Other income (expense), net

(784)

171

(1,011)

(283)

Total other expense, net

(1,756)

(794)

(2,943)

(2,200)

Loss before income taxes

(11,501)

(10,662)

(22,057)

(18,575)

Provision for income taxes

(22)

(6)

(28)

(10)

Net loss

$ (11,523)

$ (10,668)

$ (22,085)

$ (18,585)

Net loss per share attributable to common stockholders, basic

$ (0.41)

$ (0.39)

$ (0.79)

$ (0.68)

Net loss per share attributable to common stockholders, diluted

$ (0.41)

$ (0.39)

$ (0.79)

$ (0.68)

Weighted average common shares outstanding, basic

27,983,629

27,620,764

27,967,072

27,495,125

Weighted average common shares outstanding, diluted

27,983,629

27,620,764

27,967,072

27,495,125

[1]	Net revenue by country is categorized based on the location of the end customer.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (11,523)	$ (10,668)	$ (22,085)	$ (18,585)
Other comprehensive income (loss):
Foreign currency translation adjustment	(30)	(27)	(54)	(29)
Unrealized gains (losses) on marketable securities, net of tax of $0	9	(18)	(64)	(10)
Total other comprehensive income (loss)	(21)	(45)	(118)	(39)
Comprehensive loss	$ (11,544)	$ (10,713)	$ (22,203)	$ (18,624)

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Amount after tax and reclassification adjustments of other comprehensive income (loss).

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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
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	$ 0	$ 0

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Accumulated Other Comprehensive Loss	Accumulated Deficit
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	372	$ 372
Issuance of common stock upon the exercise of common stock options, Shares		287,705
Issuance of common stock in connection with employee stock purchase plan	211	$ 211
Issuance of common stock in connection with employee stock purchase plan , Shares		14,951
Stock-based compensation expense	1,112	$ 1,112
Foreign currency translation adjustment	(2)		(2)
Unrealized gains (losses) on marketable securities	8		8
Net loss	(7,917)			(7,917)
Balance at Mar. 31, 2021	97,675	$ 503,912	(89)	(406,148)
Balance, Shares at Mar. 31, 2021		27,477,961
Balance at Dec. 31, 2020	103,891	$ 502,217	(95)	(398,231)
Balance, Shares at Dec. 31, 2020		27,175,305
Foreign currency translation adjustment	(29)
Unrealized gains (losses) on marketable securities	(10)
Net loss	(18,585)
Balance at Jun. 30, 2021	88,983	$ 505,933	(134)	(416,816)
Balance, Shares at Jun. 30, 2021		27,647,234
Balance at Dec. 31, 2020	103,891	$ 502,217	(95)	(398,231)
Balance, Shares at Dec. 31, 2020		27,175,305
Net loss	(44,200)
Balance at Dec. 31, 2021	67,854	$ 510,488	(188)	(442,446)
Balance, Shares at Dec. 31, 2021		27,791,615
Balance at Mar. 31, 2021	97,675	$ 503,912	(89)	(406,148)
Balance, Shares at Mar. 31, 2021		27,477,961
Issuance of common stock upon the exercise of common stock options	213	$ 213
Issuance of common stock upon the exercise of common stock options, Shares		169,273
Stock-based compensation expense	1,808	$ 1,808
Foreign currency translation adjustment	(27)		(27)
Unrealized gains (losses) on marketable securities	(18)		(18)
Net loss	(10,668)			(10,668)
Balance at Jun. 30, 2021	88,983	$ 505,933	(134)	(416,816)
Balance, Shares at Jun. 30, 2021		27,647,234
Balance at Dec. 31, 2021	67,854	$ 510,488	(188)	(442,446)
Balance, Shares at Dec. 31, 2021		27,791,615
Issuance of common stock upon the exercise of common stock options	202	$ 202
Issuance of common stock upon the exercise of common stock options, Shares		164,503
Issuance of common stock in connection with employee stock purchase plan	203	$ 203
Issuance of common stock in connection with employee stock purchase plan , Shares		12,465
Stock-based compensation expense	2,310	$ 2,310
Foreign currency translation adjustment	(24)		(24)
Unrealized gains (losses) on marketable securities	(73)		(73)
Net loss	(10,562)			(10,562)
Balance at Mar. 31, 2022	59,910	$ 513,203	(285)	(453,008)
Balance, Shares at Mar. 31, 2022		27,968,583
Balance at Dec. 31, 2021	67,854	$ 510,488	(188)	(442,446)
Balance, Shares at Dec. 31, 2021		27,791,615
Foreign currency translation adjustment	(54)
Unrealized gains (losses) on marketable securities	(64)
Net loss	(22,085)
Balance at Jun. 30, 2022	50,919	$ 515,756	(306)	(464,531)
Balance, Shares at Jun. 30, 2022		28,023,295
Balance at Mar. 31, 2022	59,910	$ 513,203	(285)	(453,008)
Balance, Shares at Mar. 31, 2022		27,968,583
Issuance of common stock upon the exercise of common stock options	237	$ 237
Issuance of common stock upon the exercise of common stock options, Shares		31,592
Stock-based compensation expense	2,316	$ 2,316
Issuance of restricted common stock, Shares		23,120
Foreign currency translation adjustment	(30)		(30)
Unrealized gains (losses) on marketable securities	9		9
Net loss	(11,523)			(11,523)
Balance at Jun. 30, 2022	$ 50,919	$ 515,756	$ (306)	$ (464,531)
Balance, Shares at Jun. 30, 2022		28,023,295

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Cash flows from operating activities:
Net loss	$ (22,085)	$ (18,585)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	1,302	896
Stock-based compensation expense	4,626	2,920
Non-cash interest expense and end of term accretion expense	278	264
Non-cash lease expense	352
Net amortization of premiums on marketable securities	369	767
Unrealized foreign currency transaction losses	1,034	314
Changes in operating assets and liabilities:
Accounts receivable	(7,131)	560
Inventory	(4,153)	(1,894)
Prepaid expenses and other current assets	(1,153)	(1,209)
Accounts payable	(1,615)	938
Accrued expenses and other current liabilities	(242)	1,990
Deferred revenue		219
Operating lease liabilities	918
Deferred rent		(46)
Net cash used in operating activities	(27,500)	(12,866)
Cash flows from investing activities:
Purchases of property and equipment	(6,213)	(273)
Purchases of marketable securities	(9,508)	(45,461)
Proceeds from sales and maturities of marketable securities	48,250	58,810
Net cash provided by investing activities	32,529	13,076
Cash flows from financing activities:
Proceeds from issuance of common stock upon exercise of stock options	439	585
Proceeds from issuance of common stock in connection with employee stock purchase plan	203	211
Net cash provided by financing activities	642	796
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(865)	(273)
Net increase in cash, cash equivalents and restricted cash	4,806	733
Cash, cash equivalents and restricted cash, beginning of period	26,080	25,081
Cash, cash equivalents and restricted cash, end of period	30,886	25,814
Supplemental disclosure of non-cash investing activities:
Transfers of inventory to property and equipment	1,350	765
Purchases of property and equipment included in accounts payable and accrued expenses	1,327	70
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	30,386	25,314
Restricted cash	500	500
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 30,886	$ 25,814

Nature of the Business and Basis of Presentation

6 Months Ended

Jun. 30, 2022

Nature of the Business and Basis of Presentation

1. Nature of the Business and Basis of Presentation

TransMedics Group, Inc. (“TransMedics Group” and, together with its consolidated subsidiaries, the “Company”) was incorporated in the Commonwealth of Massachusetts in October 2018. TransMedics, Inc. (“TransMedics”), an operating company and wholly owned subsidiary of TransMedics Group, was incorporated in the State of Delaware in August 1998. The Company is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. The Company developed the Organ Care System (“OCS”) to replace a decades-old standard of care. The OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. The Company’s OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body.

The 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 $22.1 million for the six months ended June 30, 2022 and $44.2 million for the year ended December 31, 2021. As of June 30, 2022, the Company had an accumulated deficit of $464.5 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 $58.1 million as of June 30, 2022 in addition to the net proceeds from its debt financing in July 2022 (see Note 13), will be sufficient to fund its operations, capital expenditures, and debt service payments for at least the next 12 months following the filing of this Quarterly Report on Form 10-Q. The Company may need to seek additional funding through equity financings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.

The Company is subject to risks and uncertainties common to companies in the medical device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. 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 its 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.

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2022

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2022 and results of operations for the three and six months ended June 30, 2022 and 2021 and cash flows for the six months ended June 30, 2022 and 2021 have been made. The Company’s results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, revenue recognition, the valuation of inventory and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. 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 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 unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions.

Risk of Concentrations of Credit, Significant Customers and Significant Suppliers

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of June 30, 2022 and December 31, 2021, the Company had no allowance for credit losses.

Significant customers are those that accounted for 10% or more of the Company’s net revenue or accounts receivable. For the three months ended June 30, 2022, one customer accounted for 17% of net revenue. For the six months ended June 30, 2022, one customer accounted for 17% of net revenue. For the three months ended June 30, 2021, no customer accounted for 10% or more of net revenue. For the six months ended June 30, 2021, one customer accounted for 10% of net revenue. As of June 30, 2022, two customers accounted for 13% and 11% of accounts receivable, respectively. As of December 31, 2021, two customers accounted for 21% and 15% of accounts receivable, respectively.

Certain of the components and subassemblies included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers. Although the Company seeks to reduce dependence on those limited sources of suppliers and manufacturers, the partial or complete loss of certain of these sources could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships.

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:

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Level 1—Quoted prices in active markets for identical assets or liabilities.

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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.

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Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate.

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company has developed and is commercializing a proprietary system to preserve human organs for transplant in a near-physiologic condition to address the limitations of cold storage organ preservation. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.

Net Income (Loss) per Share

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock awards. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three and six months ended June 30, 2022 and 2021.

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect:

	As of June 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,476,064		2,708,303
Employee stock purchase plan		17,678		12,898
Restricted stock awards		23,120		—
		3,581,302		2,785,641

Marketable Securities

6 Months Ended

Jun. 30, 2022

Investments Debt And Equity Securities [Abstract]

Marketable Securities

3. Marketable Securities

Marketable securities by security type consisted of the following (in thousands):

	June 30, 2022
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
U.S. Treasury securities (due within one year)	$	24,797	$	—	$	(97	)	$	—	$	24,700
U.S. government agency bonds (due within one year)		3,000		—		(3	)		—		2,997
	$	27,797	$	—	$	(100	)	$	—	$	27,697

	December 31, 2021
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
U.S. Treasury securities (due within one year)	$	63,907	$	—	$	(33	)	$	—	$	63,874
U.S. government agency bonds (due within one year)		3,001		—		(3	)		—		2,998
	$	66,908	$	—	$	(36	)	$	—	$	66,872

Fair Value of Financial Assets and Liabilities

6 Months Ended

Jun. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value of Financial Assets and Liabilities

4. Fair Value of Financial Assets and Liabilities

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

	Fair Value Measurements at June 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	15,903	$	—	$	—	$	15,903
Marketable securities:
U.S. Treasury securities		—		24,700		—		24,700
U.S. government agency bonds		—		2,997		—		2,997
	$	15,903	$	27,697	$	—	$	43,600

	Fair Value Measurements at December 31, 2021 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	11,169	$	—	$	—	$	11,169
Marketable securities:
U.S. Treasury securities		—		63,874		—		63,874
U.S. government agency bonds		—		2,998		—		2,998
	$	11,169	$	66,872	$	—	$	78,041

Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. U.S. Treasury securities and U.S. government agency bonds were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.

Accrued Expenses And Other Current Liabilities [Abstract]

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Inventory

6 Months Ended

Jun. 30, 2022

Inventory Disclosure [Abstract]

Inventory

5. Inventory

Inventory consisted of the following (in thousands):

	June 30, 2022		December 31, 2021
Raw materials	$	8,974	$	7,274
Work-in-process		1,685		1,932
Finished goods		6,809		5,653
	$	17,468	$	14,859

During the six months ended June 30, 2022 and 2021, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $1.4 million and $0.8 million, respectively.

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2022

Accrued Expenses and Other Current Liabilities

6. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

	June 30, 2022		December 31, 2021
Accrued research, development and clinical trials expenses	$	4,200	$	4,567
Accrued payroll and related expenses		5,327		5,173
Accrued professional fees		936		1,973
Accrued other		4,957		4,624
	$	15,420	$	16,337

Long-Term Debt

6 Months Ended

Jun. 30, 2022

Debt Disclosure [Abstract]

Long-Term Debt

7. Long-Term Debt

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):

	June 30, 2022			December 31, 2021
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		(344	)		(511	)
Accrued end-of-term payment		819			708
Long-term debt, net of discount and current portion	$	35,475		$	35,197

On July 25, 2022, the Company entered into a credit agreement with Canadian Imperial Bank of Commerce (“CIBC”) for total borrowings of $60.0 million (the “CIBC Credit Agreement”) (see Note 13). A portion of the proceeds were used to repay the outstanding principal, accrued interest and end-of-term payment of the Credit Agreement with OrbiMed totaling $36.3 million. In accordance with the applicable accounting standards, a short-term debt obligation should be excluded from current liabilities if the entity has both the intent and ability to refinance the obligation on a long-term basis. The intent and ability can be demonstrated by the issuance of a long-term obligation to refinance the short-term obligation on a long-term basis after the date of an entity’s balance sheet but before that balance sheet is issued. In connection with the repayment of the outstanding borrowings under the Credit Agreement with the proceeds from the CIBC Credit Agreement and the related repayment provisions under the CIBC Credit Agreement, the Company has classified $35.5 million of long-term debt, net of discount and current portion outstanding as of June 30, 2022 under the Credit Agreement as a long-term liability.

Prior to repayment, borrowings under the Credit Agreement bore interest at an annual rate equal to the London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0% and a maximum of 4.0%, plus 8.5% (the “Applicable Margin”), subject in the aggregate to a maximum interest rate of 11.5%. In addition, borrowings under the Credit Agreement bore paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeded 11.5%, but not to exceed 12.5%. The PIK interest was added to the principal amount of the borrowings outstanding at the end of each quarter until the repayment of the borrowings in July 2022. Borrowings under the Credit Agreement were repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest was due and payable. At its option, the company could prepay outstanding borrowings under the Credit Agreement. The Company was required to make a final payment in an amount equal to 3.0% of the principal amount of any prepayment or repayment. The final payment and debt discount amounts were being accreted to interest expense over the term of the Credit Agreement using the effective interest method.

All obligations under the Credit Agreement were guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor were 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 agreed to certain affirmative and negative covenants to which it was subject until repayment. The financial covenants included 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 June 30, 2022, the Company was in compliance with the financial covenants under the Credit Agreement.

The obligations under the Credit Agreement were 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 was no longer continuing, the Applicable Margin would increase by 4.0% per annum. If an event of default (other than certain events of bankruptcy or insolvency) occurred and was continuing, OrbiMed may have declared 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 would have

automatically became due and payable. In addition, the Company may have been 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 June 30, 2022, the interest rate applicable to borrowings under the Credit Agreement was 9.5%. During the six months ended June 30, 2022, the weighted average effective interest rate on outstanding borrowings under the Credit Agreement was approximately 11.2%.

Stock-Based Compensation

6 Months Ended

Jun. 30, 2022

Stockholders Equity Note [Abstract]

Stock-Based Compensation

8. Stock-Based Compensation

2019 Stock Incentive Plan

The Company’s 2019 Stock Incentive Plan (the “2019 Plan”) provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, unrestricted stock units, and other stock-based awards to employees, directors, and consultants of the Company and its subsidiaries. The number of shares of common stock of TransMedics Group initially available for issuance under the 2019 Plan was 3,428,571 shares, plus the number of shares underlying awards under the previously outstanding 2014 Stock Incentive Plan (the “2014 Plan”), not to exceed 1,595,189 shares, that expire or are terminated, surrendered, or 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 June 30, 2022, 809,496 shares of common stock were available for issuance under the 2019 Plan.

2019 Employee Stock Purchase Plan

Pursuant to the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”), certain employees of the Company are eligible to purchase common stock of the Company at a reduced price during offering periods. The 2019 ESPP permits participants to purchase common stock using funds contributed through payroll deductions, subject to the limitations set forth in the Internal Revenue Code, at a purchase price of 85% of the lower of the closing price of the Company’s common stock on the first trading day of the offering period or the closing price on the applicable purchase date, which is the final trading day of the applicable offering period. A total of 371,142 shares of the Company’s common stock are reserved for issuance under the 2019 ESPP. During the six months ended June 30, 2022, 12,465 shares of common stock were issued under the 2019 ESPP and as of June 30, 2022, 308,131 shares of common stock remained available for issuance.

2021 Inducement Plan

In August 2021, the Company’s board of directors approved the TransMedics Group, Inc. Inducement Plan (the “Inducement Plan”). Pursuant to the terms of the Inducement Plan, the Company may grant nonstatutory stock options, stock appreciation rights, restricted stock, unrestricted stock, restricted stock unit awards and performance awards to individuals who were not previously employees or directors of the Company or individuals returning to employment after a bona fide period of non-employment with the Company. A total of 1,000,000 shares of the Company’s common stock were initially available for issuance under the Inducement Plan. As of June 30, 2022, 615,400 shares of common stock were available for issuance under the Inducement Plan.

Stock Option Activity

During the six months ended June 30, 2022, the Company granted options under the 2019 Plan and the Inducement Plan to its employees and directors with service-based vesting for the purchase of an aggregate of 1,040,210 shares of common stock with a weighted average grant-date fair value of $8.53 per share.

Restricted Common Stock Activity

During the three months ended June 30, 2022, the Company granted shares of restricted common stock. Shares of unvested restricted common stock may not be sold or transferred by the holder. If the holder’s service to the Company and its affiliates ceases for any reason, unvested shares of restricted common stock held by these individuals will immediately be forfeited for no consideration, as defined in the restricted stock agreement.

During the three months ended June 30, 2022, the Company granted 23,120 shares of restricted common stock under the 2019 Plan to consultants with service-based vesting conditions and a weighted-average grant-date fair value of $25.95 per share.

Stock-Based Compensation

The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Cost of revenue	$	31	$	19	$	56	$	32
Research, development and clinical trials expenses		364		320		685		517
Selling, general and administrative expenses		1,921		1,469		3,885		2,371
	$	2,316	$	1,808	$	4,626	$	2,920

As of June 30, 2022, total unrecognized compensation cost related to unvested share-based awards was $23.4 million, which is expected to be recognized over a weighted average period of 2.8 years.

Commitments and Contingencies

6 Months Ended

Jun. 30, 2022

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingencies

9. Commitments and Contingencies

Operating Leases

The Company leases office, laboratory and manufacturing space under two non-cancelable operating leases. There have been no material changes to the Company’s leases during the six months ended June 30, 2022. For additional information, please read Note 12 Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2021.

License Agreement with the Department of Veterans Affairs

In 2002, the Company entered into a license agreement with the Department of Veterans Affairs (the “VA”), under which the Company was granted an exclusive, worldwide license under specified patents to make, use, sell and import certain technology used in the Company’s products and a non-exclusive, worldwide license to make, use, sell and import solutions for use in or with those products. The rights under the license agreement continued until the expiration of the last to expire of the licensed patents. The majority of the licensed U.S. patents expired in 2017, and the foreign patents expired in September 2018. However, the Company requested a patent term extension for one U.S. patent covered by the VA license agreement, U.S. Patent No. 6100082 (the “’082 patent”). The Company received a Notice of Final Determination on June 27, 2022 from the United States Patent and Trademark Office (“USPTO”) finding the ‘082 patent’s term extension expired on November 6, 2021, and as a result the license has terminated. The termination of the license is not expected to have a material impact on the Company’s financial results.

As consideration for the licenses granted by the VA, the Company was obligated to pay tiered royalties ranging from a low single-digit to a mid single-digit percentage on net sales of each product covered by a licensed patent (subject to a minimum aggregate royalty payment of less than $0.1 million per year during each of the first five years after the first commercial sale, after which no minimum is required). Royalties were paid by the Company on a licensed product-by-licensed product and country-by-country basis, beginning on the first commercial sale of such licensed product in such country until expiration of the last valid patent claim covering such licensed product in such country. The Company was also responsible for all costs related to the amendment, prosecution and maintenance of the licensed patent rights. As all of the licensed patents expired as of November 6, 2021, the Company no longer has an obligation to pay royalties.

401(k) Savings Plan

The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. As of June 30, 2022 and December 31, 2021, 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 June 30, 2022 and December 31, 2021.

Unconditional Purchase Commitment

In January 2021, the Company entered into an unconditional $9.5 million purchase commitment, in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029. The contract is not cancellable without penalty. The remaining purchase commitment as of June 30, 2022 was $8.0 million.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

Segment Reporting and Geographic Data

6 Months Ended

Jun. 30, 2022

Segment Reporting [Abstract]

Segment Reporting and Geographic Data

10. Segment Reporting and Geographic Data

The Company has determined that it operates in one segment (see Note 2).

See Note 11 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands):

	June 30, 2022		December 31, 2021
Long-lived assets by country(1):
United States	$	15,515	$	9,085
All other countries		662		756
Total long-lived assets	$	16,177	$	9,841

(1)

The Company’s only long-lived assets consist of property and equipment, net of depreciation, which are categorized based on their location of domicile.

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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Revenue From Contract With Customer [Abstract]

Revenue

6 Months Ended

Jun. 30, 2022

Revenue

11. Revenue

The Company has determined that the payments made to the customer for reimbursement of clinical trial materials and customer’s costs incurred to execute specific clinical trial protocols related to the Company’s OCS products do not provide the Company with a distinct good or service transferred by the customer, and therefore such payments are recorded as a reduction of revenue from the customer in the Company’s consolidated statements of operations. Reductions of revenue related to such payments made to customers for reimbursements are recognized when the Company recognizes the revenue for the sale of its OCS disposable sets.

The reconciliation of gross revenue to net revenue for these certain payments is shown below (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Gross revenue from sales to customers	$	20,521	$	8,667	$	36,401	$	16,304
Less: clinical trial payments reducing revenue		—		496		—		1,080
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

The Company determined that payments made to customers to obtain information related to post-approval studies or existing standard-of-care protocols (i.e., unrelated to the Company’s OCS products) meet the criteria to be classified as a cost because the Company receives a distinct good or service transferred by the customer separate from the customer’s purchase of the Company’s OCS products and the consideration paid to the customer represents the fair value of the distinct good or service received. As a result, such payments made to the customers are recorded as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $0.2 million and $0.5 million for the three and six months ended June 30, 2022, respectively, as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $0.7 million and $1.2 million, respectively, for the three and six months ended June 30, 2021, respectively, as operating expenses.

Disaggregated Revenue

The Company disaggregates revenue from contracts with customers by product type and geographical area as it believes this presentation best depicts how the nature, amount, timing and uncertainty of the Company’s revenue and cash flows are affected by economic factors, as shown below (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Net revenue by OCS product:
OCS Lung net revenue	$	2,839	$	3,572	$	5,137	$	6,002
OCS Heart net revenue		8,064		4,599		13,777		8,780
OCS Liver net revenue		9,618		—		17,487		442
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Net revenue by country(1):
United States	$	18,138	$	5,758	$	31,699	$	11,515
All other countries		2,383		2,413		4,702		3,709
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

(1)

Net revenue by country is categorized based on the location of the end customer.

When a customer order includes disposable sets and organ retrieval or OCS organ management services, the Company has determined that the disposable sets and services constitute separate performance obligations and recognizes revenue as the disposable sets and services are delivered to the customer. Net revenue during the three and six months ended June 30, 2022 included service revenue comprising approximately 13% and less than 10%, respectively, of net revenue relating to organ retrieval and OCS organ management services sold under the National OCS Program, the Company’s turnkey solution to provide outsourced organ retrieval and OCS organ management.

Contract Assets and Liabilities

The Company recognizes a receivable at the point in time at which it has an unconditional right to payment. Such receivables are not contract assets. Contract assets arise from unbilled amounts in customer arrangements when revenue recognized exceeds the amount billed to the customer and the Company’s right to payment is not just subject to the passage of time. The Company had no contract assets as of June 30, 2022 and December 31, 2021.

Contract liabilities represent the Company’s obligation to transfer goods or services to a customer for which it has received consideration (or the amount is due) from the customer. The Company has determined that its only contract liabilities are deferred revenue, which consists of amounts that have been invoiced but that have not been recognized as revenue.

The Company generally satisfies performance obligations within one year of the contract inception date. As of June 30, 2022, the Company’s wholly- or partially unsatisfied performance obligations totaled $1.7 million and are expected to be completed within the next year.

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Related Party Transactions

Related Party Transactions

6 Months Ended

Jun. 30, 2022

12. Related Party Transactions

Employment of Dr. Amira Hassanein

Dr. Amira Hassanein, who serves as Product Director for the Company’s OCS Lung program, is the sister of Dr. Waleed Hassanein, the Company’s President and Chief Executive Officer and a member of the Company’s board of directors. The Company paid Dr. Amira Hassanein approximately $0.1 million and $0.2 million in total compensation for the three and six months ended June 30, 2022, respectively, and $0.1 million and $0.2 million in total compensation for the three and six months ended June 30, 2021, respectively, for her services as an employee.

Subsequent Events

6 Months Ended

Jun. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

13. Subsequent Events

Canadian Imperial Bank of Commerce Credit Agreement

On July 25, 2022, the Company entered into a credit agreement with CIBC pursuant to which CIBC made a term loan commitment of $60.0 million available to the Company. The entire term loan was drawn on July 25, 2022. The term loan under the CIBC Credit Agreement bears interest at an annual rate equal to either, at the Company’s option, (i) the secured overnight financing rate for an interest period selected by the Company, subject to a minimum of 1.5%, plus 2.0% or (ii) 1.0% plus the higher of a) the prime rate subject to a minimum of 4.0% or b) the Federal Funds Effective Rate plus 0.5%. Borrowings under the CIBC Credit Agreement are payable in monthly interest-only payments for the first 24 months, and then payable in equal monthly principal payments plus accrued interest until the maturity date of the CIBC Credit Agreement in July 2027. If certain revenue milestones are met after the first 24 months, the Company may extend the interest-only repayment period by one additional year. At its option, the Company may prepay borrowings outstanding under the CIBC Credit Agreement, subject to a prepayment fee of 2.0% of outstanding borrowings if paid prior to 12 months after the closing date, and 1.0% if paid after 12 months but prior to 24 months after the closing date. The obligations under the CIBC Credit Agreement are guaranteed by the Company’s material wholly-owned subsidiaries and are secured by substantially all of the assets of the Company and the guarantors.

Repayment of OrbiMed Credit Agreement

On July 25, 2022, the Company repaid all amounts due under the Credit Agreement with OrbiMed of $36.3 million, including $35.0 million of principal repayments, using proceeds from the borrowings under the CIBC Credit Agreement. The Credit Agreement was terminated on July 25, 2022 and all security interests securing obligations under the Credit Agreement were released.

Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2022

Unaudited Interim Financial Information

Use of Estimates

Risk of Concentrations of Credit, Significant Customers and Significant Suppliers

Fair Value Measurements

•

Level 1—Quoted prices in active markets for identical assets or liabilities.

•

Segment Information

Net Income (Loss) per Share

	As of June 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,476,064		2,708,303
Employee stock purchase plan		17,678		12,898
Restricted stock awards		23,120		—
		3,581,302		2,785,641

Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2022

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 June 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,476,064		2,708,303
Employee stock purchase plan		17,678		12,898
Restricted stock awards		23,120		—
		3,581,302		2,785,641

Marketable Securities (Tables)

6 Months Ended

Jun. 30, 2022

Investments Debt And Equity Securities [Abstract]

Components of Marketable Securities by Security Type

Marketable securities by security type consisted of the following (in thousands):

	June 30, 2022
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
U.S. Treasury securities (due within one year)	$	24,797	$	—	$	(97	)	$	—	$	24,700
U.S. government agency bonds (due within one year)		3,000		—		(3	)		—		2,997
	$	27,797	$	—	$	(100	)	$	—	$	27,697

	December 31, 2021
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
U.S. Treasury securities (due within one year)	$	63,907	$	—	$	(33	)	$	—	$	63,874
U.S. government agency bonds (due within one year)		3,001		—		(3	)		—		2,998
	$	66,908	$	—	$	(36	)	$	—	$	66,872

Fair Value of Financial Assets and Liabilities (Tables)

6 Months Ended

Jun. 30, 2022

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 and liabilities that are measured at fair value on a recurring basis (in thousands):

	Fair Value Measurements at June 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	15,903	$	—	$	—	$	15,903
Marketable securities:
U.S. Treasury securities		—		24,700		—		24,700
U.S. government agency bonds		—		2,997		—		2,997
	$	15,903	$	27,697	$	—	$	43,600

	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

Inventory (Tables)

6 Months Ended

Jun. 30, 2022

Inventory Disclosure [Abstract]

Schedule of Inventory, Current

Inventory consisted of the following (in thousands):

	June 30, 2022		December 31, 2021
Raw materials	$	8,974	$	7,274
Work-in-process		1,685		1,932
Finished goods		6,809		5,653
	$	17,468	$	14,859

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2022

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):

	June 30, 2022		December 31, 2021
Accrued research, development and clinical trials expenses	$	4,200	$	4,567
Accrued payroll and related expenses		5,327		5,173
Accrued professional fees		936		1,973
Accrued other		4,957		4,624
	$	15,420	$	16,337

Long-term Debt (Tables)

6 Months Ended

Jun. 30, 2022

Debt Disclosure [Abstract]

Schedule of Long-term Debt Instruments

Long-term debt consisted of the following (in thousands):

	June 30, 2022			December 31, 2021
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		(344	)		(511	)
Accrued end-of-term payment		819			708
Long-term debt, net of discount and current portion	$	35,475		$	35,197

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

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Schedule of Stock-Based Compensation Expense

Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2022

Stockholders Equity Note [Abstract]

The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Cost of revenue	$	31	$	19	$	56	$	32
Research, development and clinical trials expenses		364		320		685		517
Selling, general and administrative expenses		1,921		1,469		3,885		2,371
	$	2,316	$	1,808	$	4,626	$	2,920

Segment Reporting and Geographic Data (Tables)

6 Months Ended

Jun. 30, 2022

Segment Reporting [Abstract]

Long-lived assets by geographical area

See Note 11 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands):

	June 30, 2022		December 31, 2021
Long-lived assets by country(1):
United States	$	15,515	$	9,085
All other countries		662		756
Total long-lived assets	$	16,177	$	9,841

(1)

The Company’s only long-lived assets consist of property and equipment, net of depreciation, which are categorized based on their location of domicile.

Revenue (Tables)

6 Months Ended

Jun. 30, 2022

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):

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Gross revenue from sales to customers	$	20,521	$	8,667	$	36,401	$	16,304
Less: clinical trial payments reducing revenue		—		496		—		1,080
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

Schedule of Net Revenue by OCS Product and Country

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Net revenue by OCS product:
OCS Lung net revenue	$	2,839	$	3,572	$	5,137	$	6,002
OCS Heart net revenue		8,064		4,599		13,777		8,780
OCS Liver net revenue		9,618		—		17,487		442
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Net revenue by country(1):
United States	$	18,138	$	5,758	$	31,699	$	11,515
All other countries		2,383		2,413		4,702		3,709
Total net revenue	$	20,521	$	8,171	$	36,401	$	15,224

(1)

Net revenue by country is categorized based on the location of the end customer.

Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended				6 Months Ended		12 Months Ended
	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2021	Mar. 31, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Accounting Policies [Abstract]
Net loss	$ 11,523	$ 10,562	$ 10,668	$ 7,917	$ 22,085	$ 18,585	$ 44,200
Accumulated deficit	464,531				464,531		$ 442,446
Cash equivalents and marketable securities	$ 58,100				$ 58,100

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

Geographic Areas, Long-Lived Assets [Abstract]

Summary of Significant Accounting Policies - Additional Information (Detail)	3 Months Ended	6 Months Ended		12 Months Ended
	Jun. 30, 2022 USD ($)	Jun. 30, 2022 USD ($) Segment	Jun. 30, 2021	Dec. 31, 2021 USD ($)
Allowance for credit losses \| $	$ 0	$ 0		$ 0
Number of operating segments \| Segment		1
Customer Concentration Risk \| Revenue Benchmark \| Significant Customer Benchmark [Member] \| Minimum [Member]
Concentration risk percentage		10.00%
Customer Concentration Risk \| Revenue Benchmark \| Customer One [Member]
Concentration risk percentage	17.00%	17.00%	10.00%
Customer Concentration Risk \| Accounts Receivable \| Significant Customer Benchmark [Member] \| Minimum [Member]
Concentration risk percentage		10.00%
Customer Concentration Risk \| Accounts Receivable \| Customer One [Member]
Concentration risk percentage		13.00%		21.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two [Member]
Concentration risk percentage		11.00%		15.00%

Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	3,581,302	2,785,641
Warrants to purchase common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	64,440	64,440
Options to purchase common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	3,476,064	2,708,303
Employee stock purchase plan [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	17,678	12,898
Restricted stock awards [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	23,120

Marketable Securities - Components of Marketable Securities by Security Type (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	$ 27,797	$ 66,908
Marketable Securities, Gross Unrealized Losses	(100)	(36)
Marketable Securities, Fair Value	27,697	66,872
U.S. Treasury Securities (due within one year) [Member]
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	24,797	63,907
Marketable Securities, Gross Unrealized Losses	(97)	(33)
Marketable Securities, Fair Value	24,700	63,874
U.S. Government Agency Bonds (due within one year) [Member]
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	3,000	3,001
Marketable Securities, Gross Unrealized Losses	(3)	(3)
Marketable Securities, Fair Value	$ 2,997	$ 2,998

Fair Value of Financial Assets and Liabilities - Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Marketable securities:
Marketable securities	$ 27,697	$ 66,872
Cash equivalents and marketable securities	43,600	78,041
U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	24,700	63,874
U.S. Government Agency Bonds [Member]
Marketable securities:
Marketable securities	2,997	2,998
Money Market Funds [Member]
Cash equivalents:
Cash equivalents	15,903	11,169
Level 1 [Member]
Marketable securities:
Cash equivalents and marketable securities	15,903	11,169
Level 1 [Member] \| Money Market Funds [Member]
Cash equivalents:
Cash equivalents	15,903	11,169
Level 2 [Member]
Marketable securities:
Cash equivalents and marketable securities	27,697	66,872
Level 2 [Member] \| U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	24,700	63,874
Level 2 [Member] \| U.S. Government Agency Bonds [Member]
Marketable securities:
Marketable securities	$ 2,997	$ 2,998

Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 8,974	$ 7,274
Work-in-process	1,685	1,932
Finished goods	6,809	5,653
Inventory, net	$ 17,468	$ 14,859

Inventory - Additional Information (Detail) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Inventory Disclosure [Abstract]
Inventory transfer to property plant and equipment	$ 1,350	$ 765

Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Accrued Expenses And Other Current Liabilities [Abstract]
Accrued research, development and clinical trials expenses	$ 4,200	$ 4,567
Accrued payroll and related expenses	5,327	5,173
Accrued professional fees	936	1,973
Accrued other	4,957	4,624
Accrued expenses and other liabilities current	$ 15,420	$ 16,337

Long-term Debt - Additional Information (Detail) - USD ($)		6 Months Ended
	Jul. 25, 2022	Jun. 30, 2022	Dec. 31, 2021	Jun. 29, 2018
Debt Instrument [Line Items]
Long-term Debt, Gross		$ 35,000,000	$ 35,000,000
Long-term debt, net of discount and current portion		$ 35,475,000	$ 35,197,000
Orbi Med [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross				$ 35,000,000.0
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%
Final payment		3.00%
Description of covenants		The financial covenants included 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		$ 3,000,000.0
Average effective interest rate		11.20%
Orbi Med [Member] \| In Event Of Default [Member]
Debt Instrument [Line Items]
Increasing applicable margin		4.00%
Orbi Med [Member] \| Minimum [Member]
Debt Instrument [Line Items]
Paid in kind interest threshold		11.50%
Orbi Med [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Interest rate effective percentage		11.50%
Paid in kind interest threshold		12.50%
Orbi Med [Member] \| London Interbank Offered Rate (LIBOR) \| Minimum [Member]
Debt Instrument [Line Items]
LIBOR rate		1.00%
Orbi Med [Member] \| London Interbank Offered Rate (LIBOR) \| Maximum [Member]
Debt Instrument [Line Items]
LIBOR rate		4.00%
Orbi Med [Member] \| Credit Agreement [Member]
Debt Instrument [Line Items]
Debt instrument, maturity month and year		2022-07
Orbi Med [Member] \| Credit Agreement [Member] \| Subsequent Event
Debt Instrument [Line Items]
Repayment of outstanding principal, accrued interest and end-of-term payment	$ 36,300,000
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Subsequent Event \| Term Loan [Member]
Debt Instrument [Line Items]
Borrowings from long term debt	$ 60,000,000.0
Debt instrument, maturity month and year	2027-07

Long-term Debt - Schedule of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Debt Disclosure [Abstract]
Principal amount of long-term debt	$ 35,000	$ 35,000
Long-term debt, net of current portion	35,000	35,000
Debt discount, net of accretion	(344)	(511)
Accrued end-of-term payment	819	708
Long-term debt, net of discount and current portion	$ 35,475	$ 35,197

Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions		3 Months Ended	6 Months Ended
	Apr. 15, 2019	Jun. 30, 2022	Jun. 30, 2022	Aug. 31, 2021
Unrecognized compensation cost related to unvested employee and director stock-based awards		$ 23.4	$ 23.4
Weighted average period for unrecognized compensation cost			2 years 9 months 18 days
2019 Stock Plan [Member]
Share-based compensation arrangement by share-based payment award, number of shares authorized	3,428,571
Share based compensation arrangement by share based payment award number of shares available for grant		809,496	809,496
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 Stock Plan [Member] \| Restricted stock awards [Member] \| Common Stock \| Consultants [Member]
Shares granted		23,120
Share-based compensation arrangement by share-based payment award, grants in period, weighted average grant date fair value		$ 25.95
2019 Employee Stock Purchase Plan [Member]
Share-based compensation arrangement by share-based payment award, number of shares authorized		371,142	371,142
Share based compensation arrangement by share based payment award number of shares available for grant		308,131	308,131
Purchase price of common stock, percent	85.00%
Number of shares issued			12,465
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		615,400	615,400
2019 Plan and 2021 Inducement Plan [Member] \| Common Stock \| Employees and Directors [Member]
Options granted			1,040,210
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value			$ 8.53

Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Allocated Share-based Compensation Expense	$ 2,316	$ 1,808	$ 4,626	$ 2,920
Cost of revenue [Member]
Allocated Share-based Compensation Expense	31	19	56	32
Research, development and clinical trials expenses [Member]
Allocated Share-based Compensation Expense	364	320	685	517
Selling, general and administrative expenses [Member]
Allocated Share-based Compensation Expense	$ 1,921	$ 1,469	$ 3,885	$ 2,371

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions	1 Months Ended	6 Months Ended	12 Months Ended
	Jan. 31, 2021	Jun. 30, 2022	Dec. 31, 2021
Defined contribution plan, contribution amount		$ 0.0	$ 0.0
Recorded unconditional purchase commitment, minimum quantity required	$ 9.5
Recorded unconditional purchase commitment, maturity year and month	2029-12
Remaining purchase commitment		8.0
Maximum [Member]
Guaranteed minimum annual royalty payment		$ 0.1

Segment Reporting and Geographic Data - Additional Information (Detail)	6 Months Ended
	Jun. 30, 2022 Segment
Segment Reporting [Abstract]
Number of operating segments	1

Segment Reporting and Geographic Data - Geographic Areas Long Lived Assets (Detail) - USD ($)
$ in Thousands

Jun. 30, 2022

Dec. 31, 2021

Long-lived assets

^[1]

$ 16,177

$ 9,841

United States [Member]

Geographic Areas, Long-Lived Assets [Abstract]

Long-lived assets

^[1]

15,515

9,085

All Other Countries [Member]

Geographic Areas, Long-Lived Assets [Abstract]

Long-lived assets

^[1]

$ 662

$ 756

[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 Recognized Revenue Net of Payments (Detail) - USD ($)
$ in Thousands

3 Months Ended

6 Months Ended

Jun. 30, 2022

Jun. 30, 2021

Jun. 30, 2022

Jun. 30, 2021

Revenue From Contract With Customer [Abstract]

Gross revenue from sales to customers

$ 20,521

$ 8,667

$ 36,401

$ 16,304

Less: clinical trial payments reducing revenue

496

1,080

Total net revenue

^[1]

$ 20,521

$ 8,171

$ 36,401

$ 15,224

[1]	Net revenue by country is categorized based on the location of the end customer.

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

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Revenue - Additional Information (Detail) - USD ($)	3 Months Ended		6 Months Ended
Revenue - Additional Information (Detail) - USD ($)	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Revenue Recognition [Line Items]
Research development and clinical trials expenses	$ 200,000	$ 700,000	$ 500,000	$ 1,200,000
Contract assets	0		0		$ 0
Performance obligations totaled	$ 1,700,000		$ 1,700,000
Revenue performance obligation description of timing			The Company generally satisfies performance obligations within one year of the contract inception date.
Revenue Benchmark [Member] \| National OCS Program [Member] \| Product Concentration Risk [Member]
Revenue Recognition [Line Items]
Concentration risk percentage	13.00%
Revenue Benchmark [Member] \| Maximum [Member] \| National OCS Program [Member] \| Product Concentration Risk [Member]
Revenue Recognition [Line Items]
Concentration risk percentage			10.00%

Revenue - Schedule of Net Revenue by OCS Product and Country (Detail) - USD ($)
$ in Thousands

3 Months Ended

6 Months Ended

Jun. 30, 2022

Jun. 30, 2021

Jun. 30, 2022

Jun. 30, 2021

^[1]

$ 20,521

$ 8,171

$ 36,401

$ 15,224

United States [Member]

All Other Countries [Member]

^[1]

18,138

5,758

31,699

11,515

OCS Lung net revenue [Member]

^[1]

2,383

2,413

4,702

3,709

OCS Heart net revenue [Member]

2,839

3,572

5,137

6,002

OCS Liver net revenue [Member]

8,064

$ 4,599

13,777

8,780

$ 9,618

$ 17,487

$ 442

[1]	Net revenue by country is categorized based on the location of the end customer.