0001564590-22-036772 | 10-Q | XBRL Viewer

Research, development and clinical trials

^[1]

$ 25,683

$ 5,370

$ 62,084

$ 20,594

Cost of revenue

7,568

1,597

17,515

6,421

Gross profit

18,115

3,773

44,569

14,173

Operating expenses:

6,808

5,163

21,056

15,990

Selling, general and administrative

16,851

10,335

48,171

26,283

Total operating expenses

23,659

15,498

69,227

42,273

Loss from operations

(5,544)

(11,725)

(24,658)

(28,100)

Other income (expense):

Interest expense

(787)

(979)

(2,719)

(2,896)

Other expense, net

(1,076)

(249)

(2,087)

(532)

Total other expense, net

(1,863)

(1,228)

(4,806)

(3,428)

Loss before income taxes

(7,407)

(12,953)

(29,464)

(31,528)

Provision for income taxes

(19)

(9)

(47)

(19)

Net loss

$ (7,426)

$ (12,962)

$ (29,511)

$ (31,547)

Net loss per share attributable to common stockholders, basic

$ (0.25)

$ (0.47)

$ (1.03)

$ (1.14)

Net loss per share attributable to common stockholders, diluted

$ (0.25)

$ (0.47)

$ (1.03)

$ (1.14)

Weighted average common shares outstanding, basic

30,229,936

27,701,252

28,729,649

27,564,589

Weighted average common shares outstanding, diluted

30,229,936

27,701,252

28,729,649

27,564,589

[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		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (7,426)	$ (12,962)	$ (29,511)	$ (31,547)
Other comprehensive income (loss):
Foreign currency translation adjustment	(41)	3	(95)	(26)
Unrealized gains (losses) on marketable securities, net of tax of $0	100		36	(10)
Total other comprehensive income (loss)	59	3	(59)	(36)
Comprehensive loss	$ (7,367)	$ (12,959)	$ (29,570)	$ (31,583)

The 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		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 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	(26)
Unrealized gains (losses) on marketable securities	(10)
Net loss	(31,547)
Balance at Sep. 30, 2021	78,549	$ 508,458	(131)	(429,778)
Balance, Shares at Sep. 30, 2021		27,764,885
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
Issuance of common stock upon the exercise of common stock options	344	$ 344
Issuance of common stock upon the exercise of common stock options, Shares		104,753
Issuance of common stock in connection with employee stock purchase plan	208	$ 208
Issuance of common stock in connection with employee stock purchase plan , Shares		12,898
Stock-based compensation expense	1,973	$ 1,973
Foreign currency translation adjustment	3		3
Net loss	(12,962)			(12,962)
Balance at Sep. 30, 2021	78,549	$ 508,458	(131)	(429,778)
Balance, Shares at Sep. 30, 2021		27,764,885
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	(95)
Unrealized gains (losses) on marketable securities	36
Net loss	(29,511)
Balance at Sep. 30, 2022	187,857	$ 660,061	(247)	(471,957)
Balance, Shares at Sep. 30, 2022		31,933,984
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
Issuance of restricted common stock, Shares		23,120
Stock-based compensation expense	2,316	$ 2,316
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
Issuance of common stock in public offering, net of discounts and issuance costs of $676	139,854	$ 139,854
Issuance of common stock in public offering, net of discounts and issuance costs, Shares		3,737,500
Issuance of common stock upon the exercise of common stock options	1,441	$ 1,441
Issuance of common stock upon the exercise of common stock options, Shares		154,316
Issuance of common stock in connection with employee stock purchase plan	306	$ 306
Issuance of common stock in connection with employee stock purchase plan , Shares		17,678
Issuance of restricted common stock, Shares		2,973
Restricted common stock forfeitures, Shares		(1,778)
Stock-based compensation expense	2,704	$ 2,704
Foreign currency translation adjustment	(41)		(41)
Unrealized gains (losses) on marketable securities	100		100
Net loss	(7,426)			(7,426)
Balance at Sep. 30, 2022	$ 187,857	$ 660,061	$ (247)	$ (471,957)
Balance, Shares at Sep. 30, 2022		31,933,984

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands	3 Months Ended
	Sep. 30, 2022 USD ($)
Statement Of Stockholders Equity [Abstract]
Discounts and issuance costs	$ 676

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (29,511)	$ (31,547)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense	2,193	1,351
Stock-based compensation expense	7,330	4,893
Loss on extinguishment of debt	575
Loss on sale of marketable securities	107
Non-cash interest expense and end of term accretion expense	309	401
Non-cash lease expense	532
Net amortization of premiums on marketable securities	381	1,075
Unrealized foreign currency transaction losses	1,733	587
Changes in operating assets and liabilities:
Accounts receivable	(16,287)	2,650
Inventory	(6,094)	(3,964)
Prepaid expenses and other current assets	(98)	(1,392)
Accounts payable	(3,534)	1,226
Accrued expenses and other current liabilities	(8)	2,356
Deferred revenue		72
Operating lease liabilities	590
Deferred rent		76
Net cash used in operating activities	(41,782)	(22,216)
Cash flows from investing activities:
Purchases of property and equipment	(9,143)	(341)
Purchases of marketable securities	(10,496)	(66,694)
Proceeds from sales and maturities of marketable securities	76,916	86,310
Net cash provided by investing activities	57,277	19,275
Cash flows from financing activities:
Proceeds from issuance of long-term debt, net of issuance costs	58,509
Repayments of long-term debt	(36,050)
Proceeds from issuance of common stock in public offering, net of underwriting discounts and commissions and issuance costs paid	140,014
Proceeds from issuance of common stock upon exercise of stock options	1,880	929
Proceeds from issuance of common stock in connection with employee stock purchase plan	509	419
Net cash provided by financing activities	164,862	1,348
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(1,475)	(493)
Net increase (decrease) in cash, cash equivalents and restricted cash	178,882	(2,086)
Cash, cash equivalents and restricted cash, beginning of period	26,080	25,081
Cash, cash equivalents and restricted cash, end of period	204,962	22,995
Supplemental disclosure of non-cash investing activities:
Transfers of inventory to property and equipment	2,055	935
Purchases of property and equipment included in accounts payable and accrued expenses	926	342
Offering costs included in accounts payable and accrued expenses	160
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	204,462	22,495
Restricted cash	500	500
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$ 204,962	$ 22,995

Nature of the Business and Basis of Presentation

9 Months Ended

Sep. 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 $29.5 million for the nine months ended September 30, 2022 and $44.2 million for the year ended December 31, 2021. As of September 30, 2022, the Company had an accumulated deficit of $472.0 million. The Company expects to continue to generate operating losses in the foreseeable future.

The Company believes that its existing cash and cash equivalents of $204.5 million as of September 30, 2022 will be sufficient to fund its operations, capital expenditures, and debt service payments for at least the next 12 months following the filing of this Quarterly Report on Form 10-Q. The Company may need to seek additional funding through equity financings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.

The Company is subject to risks and uncertainties common to companies in the medical device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. Products currently under development will require additional research and development efforts, including additional clinical testing and regulatory approval, prior to commercialization. These efforts require additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, the Company may not obtain necessary government regulatory approval on its expected timeline or at all, and approved products may not prove commercially viable. The Company operates in an environment of rapid change in technology and competition.

The impact of the COVID-19 pandemic has been and may continue to be extensive in many aspects of society, which has resulted in and may continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Continued impacts to the Company’s business as a result of COVID-19 may include disruptions to the Company’s manufacturing operations and supply chain; labor shortages; decreased productivity and unavailability of materials or components; limitations on its employees’ and customers’ ability to travel, and delays in product installations, trainings or shipments to and from other affected countries and within the United States.

While the Company maintains an inventory of finished products and raw materials used in its OCS products, prolonged pandemic-related disruptions could lead to shortages in the raw materials necessary to manufacture its products.

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

9 Months Ended

Sep. 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 September 30, 2022 and results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022.

Use of Estimates

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

Risk of Concentrations of Credit, Significant Customers and Significant Suppliers

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

Significant customers are those that accounted for 10% or more of the Company’s net revenue or accounts receivable. For the three months ended September 30, 2022, one customer accounted for 13% of net revenue. For the nine months ended September 30, 2022, one customer accounted for 15% of net revenue. For the three months ended September 30, 2021, two customers accounted for 16% and 12% of net revenue, respectively. For the nine months ended September 30, 2021, one customer accounted for 10% of net revenue. As of September 30, 2022, there were no customers that accounted for more than 10% of accounts receivable. As of December 31, 2021, two customers accounted for 21% and 15% of accounts receivable, respectively.

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

Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

•

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

•

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

•

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

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

Segment Information

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

Net Income (Loss) per Share

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

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

	As of September 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,309,558		2,757,648
Employee stock purchase plan		8,886		3,956
Restricted stock awards		24,315		—
		3,407,199		2,826,044

Marketable Securities

9 Months Ended

Sep. 30, 2022

Investments Debt And Equity Securities [Abstract]

Marketable Securities

3. Marketable Securities

The Company did not have marketable securities as of September 30, 2022. Marketable securities by security type as of December 31, 2021 consisted of the following (in thousands):

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

Fair Value of Financial Assets and Liabilities

9 Months Ended

Sep. 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 September 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	182,091	$	—	$	—	$	182,091
	$	182,091	$	—	$	—	$	182,091

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

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

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

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Inventory

5. Inventory

Inventory consisted of the following (in thousands):

	September 30, 2022		December 31, 2021
Raw materials	$	9,439	$	7,274
Work-in-process		1,721		1,932
Finished goods		7,415		5,653
	$	18,575	$	14,859

During the nine months ended September 30, 2022 and 2021, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $2.1 million and $0.9 million, respectively.

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 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):

	September 30, 2022		December 31, 2021
Accrued research, development and clinical trials expenses	$	2,735	$	4,567
Accrued payroll and related expenses		6,064		5,173
Accrued professional fees		1,424		1,973
Accrued other		5,753		4,624
	$	15,976	$	16,337

Long-Term Debt

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Long-Term Debt

7. Long-Term Debt

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

	September 30, 2022			December 31, 2021
Principal amount of long-term debt	$	60,000		$	35,000
Less: Current portion of long-term debt		—			—
Long-term debt, net of current portion		60,000			35,000
Debt discount, net of accretion		(1,460	)		(511	)
Accrued end-of-term payment		—			708
Long-term debt, net of discount and current portion	$	58,540		$	35,197

OrbiMed Credit Agreement

The Company entered into a credit agreement with OrbiMed Royalty Opportunities II, LP (the “OrbiMed Credit Agreement”) in June 2018, pursuant to which TransMedics borrowed $35.0 million. Borrowings under the OrbiMed Credit Agreement bore interest at an annual rate equal to the London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0% and a maximum of 4.0%, plus 8.5% (the “Applicable Margin”), subject in the aggregate to a maximum interest rate of 11.5%. In addition, borrowings under the OrbiMed Credit Agreement bore paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeded 11.5%, but not to exceed 12.5%. The PIK interest was added to the principal amount of the borrowings outstanding at the end of each quarter until the repayment of the borrowings in July 2022. Borrowings under the OrbiMed Credit Agreement were repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest was due and payable. At its option, the company could prepay outstanding borrowings under the OrbiMed Credit Agreement. The Company was required to make a final payment in an amount equal to 3.0% of the principal amount of any prepayment or repayment. The final payment and debt discount amounts were being accreted to interest expense over the term of the OrbiMed Credit Agreement using the effective interest method.

In July 2022, the Company repaid amounts due under the OrbiMed Credit Agreement, including $35.0 million of principal repayments and a $1.1 million end of term payment, as well as accrued interest and the OrbiMed Credit Agreement

was terminated. Upon repayment of the outstanding amounts, the Company recorded a loss on extinguishment of debt of $0.6 million, which was classified as other expense in the consolidated statements of operations.

Canadian Imperial Bank of Commerce Credit Agreement

In July 2022, the Company entered into a credit agreement with Canadian Imperial Bank of Commerce (“CIBC”), pursuant to which the Company borrowed $60.0 million (the “CIBC Credit Agreement”).

Borrowings under the CIBC Credit Agreement bear interest at an annual rate equal to either, at the Company’s option, (i) the secured overnight financing rate for an interest period selected by the Company, subject to a minimum of 1.5%, plus 2.0% or (ii) 1.0% plus the higher of a) the prime rate subject to a minimum of 4.0% or b) the Federal Funds Effective Rate, plus 0.5%. Borrowings under the CIBC Credit Agreement are payable in monthly interest-only payments for the first 24 months, and then payable in equal monthly principal payments plus accrued interest until the maturity date of the CIBC Credit Agreement in July 2027. If certain revenue milestones are met after the first 24 months, the Company may extend the interest-only repayment period by one additional year. At the Company’s option, the Company may prepay borrowings outstanding under the CIBC Credit Agreement, subject to a prepayment fee of 2.0% of outstanding borrowings if paid prior to 12 months after the closing date, and 1.0% if paid on or after 12 months after the closing date but prior to 24 months after the closing date.

In connection with entering into the CIBC Credit Agreement, the Company paid upfront fees and other costs of $1.5 million, which were recorded by the Company as a debt discount. The debt discount is reflected as a reduction of the carrying value of long-term debt on the Company’s consolidated balance sheet and is being accreted to interest expense over the term of the CIBC Credit Agreement using the effective interest method.

All obligations under the CIBC Credit Agreement are guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor are secured by substantially all of the Company’s and each guarantor’s assets, including their intellectual property, subject to certain exceptions. Under the CIBC Credit Agreement, the Company has agreed to customary representations and warranties, events of default and certain affirmative and negative covenants to which it will remain subject until maturity. The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain) for the trailing four month period (only if EBITDA is negative) and (ii) $10.0 million, and (y) a requirement to maintain total net revenue of at least 75% of the level set forth in the total revenue plan presented to CIBC. The obligations under the CIBC Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in the Company’s business), failure to comply with certain covenants and a material adverse change in the Company’s business, operations or financial condition. As of September 30, 2022, the Company was in compliance with all financial covenants of the CIBC Credit Agreement.

During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0%. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, CIBC may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, the Company may be required to prepay outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.

The Company assessed all terms and features of the CIBC Credit Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the debt. The Company determined that all features of the CIBC Credit Agreement are either clearly and closely associated with a debt host or have a de minimis fair value and, as such, do not require separate accounting as a derivative liability.

As of September 30, 2022, the interest rate applicable to borrowings under the CIBC Credit Agreement was 4.5%. During the three months ended September 30, 2022, the weighted average effective interest rate on outstanding borrowings under the CIBC Credit Agreement was approximately 5.2%.

Stock-Based Compensation

9 Months Ended

Sep. 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 canceled without the delivery of shares, are forfeited to or repurchased by TransMedics Group or otherwise become available again for grant. Since the effectiveness of the Company’s 2019 Plan in April 2019, no future awards will be made under the 2014 Plan.

Shares withheld in payment of the exercise or purchase price of an award or in satisfaction of tax withholding requirements, and the shares covered by a stock appreciation right for which any portion is settled in stock, will reduce the number of shares available for issuance under the 2019 Plan. In addition, the number of shares available for issuance under the 2019 Plan (i) will not be increased by any shares delivered under the 2019 Plan that are subsequently repurchased using proceeds directly attributable to stock option exercises and (ii) will not be reduced by any awards that are settled in cash or that expire, become unexercisable, terminate or are forfeited to or repurchased by TransMedics Group without the issuance of stock under the 2019 Plan. As of September 30, 2022, 819,791 shares of common stock were available for issuance under the 2019 Plan.

2019 Employee Stock Purchase Plan

Pursuant to the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”), certain employees of the Company are eligible to purchase common stock of the Company at a reduced price during offering periods. The 2019 ESPP permits participants to purchase common stock using funds contributed through payroll deductions, subject to the limitations set forth in the Internal Revenue Code, at a purchase price of 85% of the lower of the closing price of the Company’s common stock on the first trading day of the offering period or the closing price on the applicable purchase date, which is the final trading day of the applicable offering period. A total of 371,142 shares of the Company’s common stock are reserved for issuance under the 2019 ESPP. During the nine months ended September 30, 2022, 30,143 shares of common stock were issued under the 2019 ESPP and as of September 30, 2022, 290,453 shares of common stock remained available for issuance.

2021 Inducement Plan

In August 2021, the Company’s board of directors approved the TransMedics Group, Inc. Inducement Plan (the “Inducement Plan”). Pursuant to the terms of the Inducement Plan, the Company may grant nonstatutory stock options, stock appreciation rights, restricted stock, unrestricted stock, restricted stock unit awards and performance awards to individuals who were not previously employees or directors of the Company or individuals returning to employment after a bona fide period of non-employment with the Company. A total of 1,000,000 shares of the Company’s common stock were initially available for issuance under the Inducement Plan. As of September 30, 2022, 616,100 shares of common stock remained available for issuance under the Inducement Plan.

Stock Option Activity

During the nine months ended September 30, 2022, the Company granted options under the 2019 Plan and the Inducement Plan to its employees and directors with service-based vesting for the purchase of an aggregate of 1,057,510 shares of common stock with a weighted average grant-date fair value of $8.91 per share.

Restricted Common Stock Activity

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

During the nine months ended September 30, 2022, the Company granted 26,093 shares of restricted common stock under the 2019 Plan to consultants with service-based vesting conditions and a weighted-average grant-date fair value of $28.74 per share.

Stock-Based Compensation

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

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Cost of revenue	$	33	$	20	$	89	$	52
Research, development and clinical trials expenses		394		312		1,079		829
Selling, general and administrative expenses		2,277		1,641		6,162		4,012
	$	2,704	$	1,973	$	7,330	$	4,893

As of September 30, 2022, total unrecognized compensation cost related to unvested share-based awards was $21.1 million, which is expected to be recognized over a weighted average period of 2.6 years.

Commitments and Contingencies

9 Months Ended

Sep. 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 nine months ended September 30, 2022. For additional information, please read Note 12 Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2021.

License Agreement with the Department of Veterans Affairs

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

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

401(k) Savings Plan

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

Unconditional Purchase Commitment

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

Legal Proceedings

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

Segment Reporting and Geographic Data

9 Months Ended

Sep. 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):

	September 30, 2022		December 31, 2021
Long-lived assets by country(1):
United States	$	17,886	$	9,085
All other countries		586		756
Total long-lived assets	$	18,472	$	9,841

(1)

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

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

9 Months Ended

Sep. 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 September 30,					Nine Months Ended September 30,
	2022			2021		2022			2021
Gross revenue from sales to customers	$	24,303		$	5,413	$	60,704		$	21,717
Less: clinical trial payments		(1,380	)		43		(1,380	)		1,123
Total net revenue	$	25,683		$	5,370	$	62,084		$	20,594

Clinical trial payments for the three and nine months ended September 30, 2022 include adjustments for certain clinical trial accrual estimates. As clinical trials reach the end of their follow up period, the Company updates its accrual estimates. The Company will continue to update its clinical trial accrual estimates as all information related to clinical trial payments is received.

The Company determined that payments made to customers to obtain information related to post-approval studies or existing standard-of-care protocols (i.e., unrelated to the Company’s OCS products) meet the criteria to be classified as a cost because the Company receives a distinct good or service transferred by the customer separate from the customer’s purchase of the Company’s OCS products and the consideration paid to the customer represents the fair value of the distinct good or service received. As a result, such payments made to the customers are recorded as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $0.5 million and $1.0 million for the three and nine months ended September 30, 2022, respectively, as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $0.4 million and $1.6 million for the three and nine months ended September 30, 2021, respectively, as operating expenses.

Disaggregated Revenue

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

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net revenue by OCS product:
OCS Lung net revenue	$	1,599	$	2,522	$	6,736	$	8,524
OCS Heart net revenue		11,541		2,848		25,318		11,628
OCS Liver net revenue		12,543		—		30,030		442
Total net revenue	$	25,683	$	5,370	$	62,084	$	20,594

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net revenue by country(1):
United States	$	23,285	$	3,112	$	54,984	$	14,627
All other countries		2,398		2,258		7,100		5,967
Total net revenue	$	25,683	$	5,370	$	62,084	$	20,594

(1)

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

When a customer order includes disposable sets and organ retrieval or OCS organ management services, the Company has determined that the disposable sets and services constitute separate performance obligations and recognizes revenue as the disposable sets and services are delivered to the customer. Net revenue during the three and nine months ended September 30, 2022 included service revenue comprising approximately 17% and 13%, respectively, of net revenue relating to organ retrieval and OCS organ management services sold under the National OCS Program, the Company’s turnkey solution to provide outsourced organ retrieval and OCS organ management.

Contract Assets and Liabilities

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

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

The Company generally satisfies performance obligations within one year of the contract inception date. As of September 30, 2022, the Company’s wholly or partially unsatisfied performance obligations totaled $1.6 million and are expected to be completed within the next year.

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.

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Related Party Transactions

Related Party Transactions

9 Months Ended

Sep. 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 $0.3 million in total compensation for the three and nine months ended September 30, 2022, respectively, and $0.1 million and $0.3 million in total compensation for the three and nine months ended September 30, 2021, respectively, for her services as an employee.

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 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 September 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,309,558		2,757,648
Employee stock purchase plan		8,886		3,956
Restricted stock awards		24,315		—
		3,407,199		2,826,044

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 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 September 30,
	2022		2021
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		3,309,558		2,757,648
Employee stock purchase plan		8,886		3,956
Restricted stock awards		24,315		—
		3,407,199		2,826,044

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2022

Investments Debt And Equity Securities [Abstract]

Components of Marketable Securities by Security Type

The Company did not have marketable securities as of September 30, 2022. Marketable securities by security type as of December 31, 2021 consisted of the following (in thousands):

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

Fair Value of Financial Assets and Liabilities (Tables)

9 Months Ended

Sep. 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 September 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	182,091	$	—	$	—	$	182,091
	$	182,091	$	—	$	—	$	182,091

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

Inventory (Tables)

9 Months Ended

Sep. 30, 2022

Inventory Disclosure [Abstract]

Schedule of Inventory, Current

Inventory consisted of the following (in thousands):

	September 30, 2022		December 31, 2021
Raw materials	$	9,439	$	7,274
Work-in-process		1,721		1,932
Finished goods		7,415		5,653
	$	18,575	$	14,859

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 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):

	September 30, 2022		December 31, 2021
Accrued research, development and clinical trials expenses	$	2,735	$	4,567
Accrued payroll and related expenses		6,064		5,173
Accrued professional fees		1,424		1,973
Accrued other		5,753		4,624
	$	15,976	$	16,337

Long-term Debt (Tables)

9 Months Ended

Sep. 30, 2022

Debt Disclosure [Abstract]

Schedule of Long-term Debt Instruments

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

	September 30, 2022			December 31, 2021
Principal amount of long-term debt	$	60,000		$	35,000
Less: Current portion of long-term debt		—			—
Long-term debt, net of current portion		60,000			35,000
Debt discount, net of accretion		(1,460	)		(511	)
Accrued end-of-term payment		—			708
Long-term debt, net of discount and current portion	$	58,540		$	35,197

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)

9 Months Ended

Sep. 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 September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Cost of revenue	$	33	$	20	$	89	$	52
Research, development and clinical trials expenses		394		312		1,079		829
Selling, general and administrative expenses		2,277		1,641		6,162		4,012
	$	2,704	$	1,973	$	7,330	$	4,893

Segment Reporting and Geographic Data (Tables)

9 Months Ended

Sep. 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):

	September 30, 2022		December 31, 2021
Long-lived assets by country(1):
United States	$	17,886	$	9,085
All other countries		586		756
Total long-lived assets	$	18,472	$	9,841

(1)

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

Revenue (Tables)

9 Months Ended

Sep. 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 September 30,					Nine Months Ended September 30,
	2022			2021		2022			2021
Gross revenue from sales to customers	$	24,303		$	5,413	$	60,704		$	21,717
Less: clinical trial payments		(1,380	)		43		(1,380	)		1,123
Total net revenue	$	25,683		$	5,370	$	62,084		$	20,594

Schedule of Net Revenue by OCS Product and Country

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net revenue by OCS product:
OCS Lung net revenue	$	1,599	$	2,522	$	6,736	$	8,524
OCS Heart net revenue		11,541		2,848		25,318		11,628
OCS Liver net revenue		12,543		—		30,030		442
Total net revenue	$	25,683	$	5,370	$	62,084	$	20,594

	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Net revenue by country(1):
United States	$	23,285	$	3,112	$	54,984	$	14,627
All other countries		2,398		2,258		7,100		5,967
Total net revenue	$	25,683	$	5,370	$	62,084	$	20,594

(1)

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

Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended						9 Months Ended		12 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Accounting Policies [Abstract]
Net loss	$ 7,426	$ 11,523	$ 10,562	$ 12,962	$ 10,668	$ 7,917	$ 29,511	$ 31,547	$ 44,200
Accumulated deficit	471,957						471,957		$ 442,446
Cash equivalents and marketable securities	$ 204,500						$ 204,500

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		9 Months Ended		12 Months Ended
	Sep. 30, 2022 USD ($)	Sep. 30, 2021	Sep. 30, 2022 USD ($) Segment	Sep. 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	13.00%	16.00%	15.00%	10.00%
Customer Concentration Risk \| Revenue Benchmark \| Customer Two [Member]
Concentration risk percentage		12.00%
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					21.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two [Member]
Concentration risk percentage					15.00%

Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	3,407,199	2,826,044
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	3,309,558	2,757,648
Employee stock purchase plan [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	8,886	3,956
Restricted stock awards [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount	24,315

Marketable Securities - Additional Information (Detail)	Sep. 30, 2022 USD ($)
Investments Debt And Equity Securities [Abstract]
Marketable Securities	$ 0

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

Fair Value of Financial Assets and Liabilities - Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Cash equivalents:
Cash equivalents and marketable securities	$ 182,091	$ 78,041
Marketable securities:
Marketable securities		66,872
U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities		63,874
U.S. Government Agency Bonds [Member]
Marketable securities:
Marketable securities		2,998
Money Market Funds [Member]
Cash equivalents:
Cash equivalents	182,091	11,169
Level 1 [Member]
Cash equivalents:
Cash equivalents and marketable securities	182,091	11,169
Level 1 [Member] \| Money Market Funds [Member]
Cash equivalents:
Cash equivalents	$ 182,091	11,169
Level 2 [Member]
Cash equivalents:
Cash equivalents and marketable securities		66,872
Level 2 [Member] \| U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities		63,874
Level 2 [Member] \| U.S. Government Agency Bonds [Member]
Marketable securities:
Marketable securities		$ 2,998

Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 9,439	$ 7,274
Work-in-process	1,721	1,932
Finished goods	7,415	5,653
Inventory, net	$ 18,575	$ 14,859

Inventory - Additional Information (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Inventory Disclosure [Abstract]
Inventory transfer to property plant and equipment	$ 2,055	$ 935

Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Accrued Expenses And Other Current Liabilities [Abstract]
Accrued research, development and clinical trials expenses	$ 2,735	$ 4,567
Accrued payroll and related expenses	6,064	5,173
Accrued professional fees	1,424	1,973
Accrued other	5,753	4,624
Accrued expenses and other liabilities current	$ 15,976	$ 16,337

Long-term Debt - Schedule of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Debt Disclosure [Abstract]
Principal amount of long-term debt	$ 60,000	$ 35,000
Long-term debt, net of current portion	60,000	35,000
Debt discount, net of accretion	(1,460)	(511)
Accrued end-of-term payment		708
Long-term debt, net of discount and current portion	$ 58,540	$ 35,197

Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands	1 Months Ended	9 Months Ended
	Jul. 31, 2022	Sep. 30, 2022	Dec. 31, 2021	Jun. 29, 2018
Debt Instrument [Line Items]
Long-term Debt, Gross		$ 60,000	$ 35,000
Repayments of long-term debt		36,050
Loss on extinguishment of debt		$ 575
Orbi Med [Member]
Debt Instrument [Line Items]
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%
Final payment		3.00%
Repayments of long-term debt	$ 35,000
Debt instrument, end of term payment accrued interest	1,100
Loss on extinguishment of debt	600
Orbi Med [Member] \| Credit Agreement [Member]
Debt Instrument [Line Items]
Debt instrument, maturity month and year		2022-07
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%
Canadian Imperial Bank of Commerce [Member]
Debt Instrument [Line Items]
Interest rate effective percentage		4.50%
Average effective interest rate		5.20%
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Term Loan [Member]
Debt Instrument [Line Items]
Long-term Debt, Gross	$ 60,000
Debt instrument, maturity month and year	2027-07
Debt Instrument, Frequency of Periodic Payment	monthly
Interest Only Payment Period	24 months
Interest Only Payment Additional Extension Period	1 year
Debt Instrument, Payment Terms	Borrowings under the CIBC Credit Agreement are payable in monthly interest-only payments for the first 24 months, and then payable in equal monthly principal payments plus accrued interest until the maturity date of the CIBC Credit Agreement in July 2027. If certain revenue milestones are met after the first 24 months, the Company may extend the interest-only repayment period by one additional year.
Description of covenants		The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain) for the trailing four month period (only if EBITDA is negative) and (ii) $10.0 million, and (y) a requirement to maintain total net revenue of at least 75% of the level set forth in the total revenue plan presented to CIBC.
Minimum liquidity covenant amount		$ 10,000
Minimum percentage to maintain total net revenue set forth in total revenue plan presented		75.00%
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Term Loan [Member] \| In Event Of Default [Member]
Debt Instrument [Line Items]
Increasing applicable margin		2.00%
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Term Loan [Member] \| Upfront Fees and Other Costs [Member]
Debt Instrument [Line Items]
Debt instrument discount gross	$ 1,500
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Interest Rate Option Two \| Term Loan [Member]
Debt Instrument [Line Items]
LIBOR rate	1.00%
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| Prior to 12 Months After Closing Date [Member] \| Term Loan [Member]
Debt Instrument [Line Items]
Debt instrument, prepayment fee percentage	2.00%
Canadian Imperial Bank of Commerce [Member] \| Credit Agreement [Member] \| 12 to 24 Months After Closing Date [Member] \| Term Loan [Member]
Debt Instrument [Line Items]
Debt instrument, prepayment fee percentage	1.00%
Canadian Imperial Bank of Commerce [Member] \| Term Secured Overnight Financing Rate [Member] \| Credit Agreement [Member] \| Interest Rate Option One [Member] \| Term Loan [Member]
Debt Instrument [Line Items]
Basis spread on variable rate	2.00%
Canadian Imperial Bank of Commerce [Member] \| Term Secured Overnight Financing Rate [Member] \| Minimum [Member] \| Credit Agreement [Member] \| Interest Rate Option One [Member] \| Term Loan [Member]
Debt Instrument [Line Items]
LIBOR rate	1.50%
Canadian Imperial Bank of Commerce [Member] \| Prime Rate \| Minimum [Member] \| Credit Agreement [Member] \| Interest Rate Option Two \| Term Loan [Member]
Debt Instrument [Line Items]
Basis spread on variable rate	4.00%
Canadian Imperial Bank of Commerce [Member] \| Amount Over Federal Funds Effective Rate [Member] \| Minimum [Member] \| Credit Agreement [Member] \| Interest Rate Option Two \| Term Loan [Member]
Debt Instrument [Line Items]
Basis spread on variable rate	0.50%

Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions		9 Months Ended
	Apr. 15, 2019	Sep. 30, 2022	Aug. 31, 2021
Unrecognized compensation cost related to unvested employee and director stock-based awards		$ 21.1
Weighted average period for unrecognized compensation cost		2 years 7 months 6 days
2019 Stock Plan [Member]
Share-based compensation arrangement by share-based payment award, number of shares authorized	3,428,571
Share based compensation arrangement by share based payment award number of shares available for grant		819,791
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		26,093
Share-based compensation arrangement by share-based payment award, grants in period, weighted average grant date fair value		$ 28.74
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		290,453
Purchase price of common stock, percent	85.00%
Number of shares issued		30,143
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		616,100
2019 Plan and 2021 Inducement Plan [Member] \| Common Stock \| Employees and Directors [Member]
Options granted		1,057,510
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value		$ 8.91

Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Allocated Share-based Compensation Expense	$ 2,704	$ 1,973	$ 7,330	$ 4,893
Cost of revenue [Member]
Allocated Share-based Compensation Expense	33	20	89	52
Research, development and clinical trials expenses [Member]
Allocated Share-based Compensation Expense	394	312	1,079	829
Selling, general and administrative expenses [Member]
Allocated Share-based Compensation Expense	$ 2,277	$ 1,641	$ 6,162	$ 4,012

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions	1 Months Ended	9 Months Ended	12 Months Ended
	Jan. 31, 2021	Sep. 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)	9 Months Ended
	Sep. 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

Sep. 30, 2022

Dec. 31, 2021

Long-lived assets

^[1]

$ 18,472

$ 9,841

United States [Member]

Geographic Areas, Long-Lived Assets [Abstract]

Long-lived assets

^[1]

17,886

9,085

All Other Countries [Member]

Geographic Areas, Long-Lived Assets [Abstract]

Long-lived assets

^[1]

$ 586

$ 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

9 Months Ended

Sep. 30, 2022

Sep. 30, 2021

Sep. 30, 2022

Sep. 30, 2021

Revenue From Contract With Customer [Abstract]

Gross revenue from sales to customers

$ 24,303

$ 5,413

$ 60,704

$ 21,717

Less: clinical trial payments

(1,380)

1,123

Total net revenue

^[1]

$ 25,683

$ 5,370

$ 62,084

$ 20,594

[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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-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(B))
-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442552-122756

Reference 22: http://www.xbrl.org/2009/role/commonPracticeRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(ii))
-URI https://asc.fasb.org/extlink&oid=126975872&loc=SL124442526-122756

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(1))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Revenue - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
Revenue - Additional Information (Detail) - USD ($)	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Revenue Recognition [Line Items]
Research development and clinical trials expenses	$ 500,000	$ 400,000	$ 1,000,000.0	$ 1,600,000
Contract assets	0		0		$ 0
Performance obligations totaled	$ 1,600,000		$ 1,600,000
Revenue performance obligation description of timing			The Company generally satisfies performance obligations within one year of the contract inception date.
Revenue Benchmark [Member] \| Product Concentration Risk [Member] \| National OCS Program [Member]
Revenue Recognition [Line Items]
Concentration risk percentage	17.00%		13.00%

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

3 Months Ended

9 Months Ended

Sep. 30, 2022

Sep. 30, 2021

Sep. 30, 2022

Sep. 30, 2021

^[1]

$ 25,683

$ 5,370

$ 62,084

$ 20,594

United States [Member]

All Other Countries [Member]

^[1]

23,285

3,112

54,984

14,627

OCS Lung net revenue [Member]

^[1]

2,398

2,258

7,100

5,967

OCS Heart net revenue [Member]

1,599

2,522

6,736

8,524

OCS Liver net revenue [Member]

11,541

$ 2,848

25,318

11,628

$ 12,543

$ 30,030

$ 442

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