Research, development and clinical trials

^[1]

$ 7,205

$ 4,039

$ 17,547

$ 9,473

Cost of revenue

2,989

1,907

7,425

5,238

Gross profit

4,216

2,132

10,122

4,235

Operating expenses:

4,939

3,272

13,608

10,170

Selling, general and administrative

6,519

2,799

17,423

7,941

Total operating expenses

11,458

6,071

31,031

18,111

Loss from operations

(7,242)

(3,939)

(20,909)

(13,876)

Other income (expense):

Interest expense

(1,084)

(1,076)

(3,290)

(1,647)

Change in fair value of preferred stock warrant liability

(183)

(341)

(423)

Other income (expense), net

101

200

(152)

Total other expense, net

(1,028)

(1,158)

(3,431)

(2,222)

Loss before income taxes

(8,270)

(5,097)

(24,340)

(16,098)

Provision for income taxes

(10)

(8)

(30)

(23)

Net loss

$ (8,280)

$ (5,105)

$ (24,370)

$ (16,121)

Net loss per share attributable to common stockholders, basic and diluted

$ (0.39)

$ (3.73)

$ (2.05)

$ (11.97)

Weighted average common shares outstanding, basic and diluted

21,131,618

1,368,260

11,882,626

1,346,942

[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. 28, 2019	Sep. 29, 2018	Sep. 28, 2019	Sep. 29, 2018
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (8,280)	$ (5,105)	$ (24,370)	$ (16,121)
Other comprehensive income (loss):
Foreign currency translation adjustment	56	12	69	4
Unrealized gains on marketable securities, net of tax of $0	22		52	7
Total other comprehensive income (loss)	78	12	121	11
Comprehensive loss	$ (8,202)	$ (5,093)	$ (24,249)	$ (16,110)

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

+ References + Details

CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit	Convertible Preferred Stock [Member]
Balance at Dec. 30, 2017	$ (168,724)	$ 1	$ 143,604	$ (149)	$ (312,180)	$ 186,519
Balance, Shares at Dec. 30, 2017		1,330,693				50,404,140
Issuance of common stock upon the exercise of common stock options	12		12
Issuance of common stock upon the exercise of common stock options, Shares		5,357
Abandonment of shares of common stock by stockholders, Shares		(307)
Stock-based compensation expense	27		27
Foreign currency translation adjustment	(6)			(6)
Unrealized gains on marketable securities	4			4
Net loss	(4,901)				(4,901)
Balance at Mar. 31, 2018	(173,588)	$ 1	143,643	(151)	(317,081)	$ 186,519
Balance, Shares at Mar. 31, 2018		1,335,743				50,404,140
Issuance of common stock upon the exercise of common stock options	9		9
Issuance of common stock upon the exercise of common stock options, Shares		23,019
Stock-based compensation expense	34		34
Foreign currency translation adjustment	(2)			(2)
Unrealized gains on marketable securities	3			3
Net loss	(6,115)				(6,115)
Balance at Jun. 30, 2018	(179,659)	$ 1	143,686	(150)	(323,196)	$ 186,519
Balance, Shares at Jun. 30, 2018		1,358,762				50,404,140
Issuance of common stock upon the exercise of common stock options	24		24
Issuance of common stock upon the exercise of common stock options, Shares		34,731
Stock-based compensation expense	31		31
Foreign currency translation adjustment	12			12
Net loss	(5,105)				(5,105)
Balance at Sep. 29, 2018	(184,697)	$ 1	143,741	(138)	(328,301)	$ 186,519
Balance, Shares at Sep. 29, 2018		1,393,493				50,404,140
Balance at Dec. 29, 2018	(192,242)	$ 1	143,794	(101)	(335,936)	$ 186,519
Balance, Shares at Dec. 29, 2018		1,397,493				50,404,140
Issuance of common stock upon the exercise of common stock options	8		8
Issuance of common stock upon the exercise of common stock options, Shares		29,180
Stock-based compensation expense	57		57
Foreign currency translation adjustment	34			34
Net loss	(6,895)				(6,895)
Balance at Mar. 30, 2019	(199,038)	$ 1	143,859	(67)	(342,831)	$ 186,519
Balance, Shares at Mar. 30, 2019		1,426,673				50,404,140
Balance at Dec. 29, 2018	(192,242)	$ 1	143,794	(101)	(335,936)	$ 186,519
Balance, Shares at Dec. 29, 2018		1,397,493				50,404,140
Foreign currency translation adjustment	69
Unrealized gains on marketable securities	52
Net loss	(24,370)
Balance at Sep. 28, 2019	63,472	$ 423,758		20	(360,306)
Balance, Shares at Sep. 28, 2019		21,161,433
Balance at Mar. 30, 2019	(199,038)	$ 1	143,859	(67)	(342,831)	$ 186,519
Balance, Shares at Mar. 30, 2019		1,426,673				50,404,140
Conversion of convertible preferred stock into common stock upon initial public offering	186,519	$ 186,519				$ (186,519)
Conversion of convertible preferred stock into common stock upon initial public offering, Shares		13,119,424				(50,404,140)
Conversion of TransMedics' common stock into TransMedics Group's common stock upon Corporate Reorganization		$ 143,859	$ (143,859)
Conversion of preferred stock warrants into common stock warrants upon initial public offering	1,239	1,239
Issuance of common stock in initial public offering, net of underwriting discounts and other offering costs of $5,966	91,401	$ 91,401
Issuance of common stock in initial public offering, net of underwriting discounts and other offering costs of $5,966, Shares		6,543,500
Issuance of common stock upon the exercise of common stock options	6	$ 6
Issuance of common stock upon the exercise of common stock options, Shares		8,771
Stock-based compensation expense	220	$ 220
Foreign currency translation adjustment	(21)			(21)
Unrealized gains on marketable securities	30			30
Net loss	(9,195)				(9,195)
Balance at Jun. 29, 2019	71,161	$ 423,245		(58)	(352,026)
Balance, Shares at Jun. 29, 2019		21,098,368
Issuance of common stock upon the exercise of common stock options	94	$ 94
Issuance of common stock upon the exercise of common stock options, Shares		63,065
Settlement of accrued financing fee	124	$ 124
Stock-based compensation expense	295	295
Foreign currency translation adjustment	56			56
Unrealized gains on marketable securities	22			22
Net loss	(8,280)				(8,280)
Balance at Sep. 28, 2019	$ 63,472	$ 423,758		$ 20	$ (360,306)
Balance, Shares at Sep. 28, 2019		21,161,433

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended	9 Months Ended		12 Months Ended
	Sep. 29, 2018	Sep. 28, 2019	Sep. 29, 2018	Dec. 29, 2018
Cash flows from operating activities:
Net loss		$ (24,370)	$ (16,121)	$ (23,800)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		866	550
Stock-based compensation expense		572	92
Change in fair value of preferred stock warrant liability	$ 183	341	423
Non-cash interest expense		352	116
Net amortization (accretion) of premiums (discounts) on marketable securities		(136)	9
Loss on extinguishment of debt			305
Unrealized foreign currency transaction (gains) losses		392	(10)
Changes in operating assets and liabilities:
Accounts receivable		(3,098)	(2,979)
Inventory		(3,238)	(2,818)
Prepaid expenses and other current assets		(314)	(183)
Accounts payable		1,054	(753)
Accrued expenses and other current liabilities		2,954	1,805
Deferred revenue		(136)	(54)
Deferred rent		(261)	(246)
Net cash used in operating activities		(25,022)	(19,864)
Cash flows from investing activities:
Purchases of property and equipment		(184)	(284)
Purchases of marketable securities		(67,677)
Proceeds from sales and maturities of marketable securities			12,725
Net cash provided by (used in) investing activities		(67,861)	12,441
Cash flows from financing activities:
Repayments of long-term debt			(9,076)
Proceeds from issuance of long-term debt, net of issuance costs			33,436
Proceeds from issuance of common stock in initial public offering, net of underwriting discounts and commissions		97,367
Payments of initial public offering and other financing costs		(4,506)	(61)
Proceeds from issuance of common stock upon exercise of stock options		108	45
Net cash provided by financing activities		92,969	24,344
Effect of exchange rate changes on cash, cash equivalents and restricted cash		80	33
Net increase in cash, cash equivalents and restricted cash		166	16,954
Cash, cash equivalents and restricted cash, beginning of period		20,741	12,436
Cash, cash equivalents and restricted cash, end of period	$ 29,390	20,907	29,390	$ 20,741
Supplemental disclosure of non-cash investing and financing activities:
Conversion of convertible preferred stock to common stock upon initial public offering		186,519
Reclassification of warrant liability to equity upon initial public offering		1,239
Transfers of inventory to property and equipment		1,904	1,168
Purchases of property and equipment included in accounts payable		90
Settlement of accrued financing fee		124
Offering costs included in accounts payable and accrued expenses		$ 120	$ 1,407

Nature of the Business and Basis of Presentation

9 Months Ended

Sep. 28, 2019

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.

On May 6, 2019, immediately prior to the closing of the Company’s initial public offering (the “IPO”), the Company completed a corporate reorganization whereby TransMedics, the direct parent of TransMedics Group prior to the corporate reorganization, became a direct, wholly-owned subsidiary of TransMedics Group pursuant to the merger of TMDX, Inc., a direct, wholly-owned subsidiary of TransMedics Group prior to the corporate reorganization, with and into TransMedics, with TransMedics as the surviving corporation. Pursuant to the terms of an agreement and plan of merger and reorganization, as a result of the merger, each outstanding share of common stock of TransMedics was converted into shares of common stock of TransMedics Group on a 3.5-for-one basis, each outstanding share of convertible preferred stock of TransMedics was converted into shares of common stock of TransMedics Group based on the conversion ratio of each individual series of preferred stock, as defined in the certificate of incorporation of TransMedics prior to the conversion, and the 3.5-for-one ratio on which shares of common stock of TransMedics were converted into common stock of TransMedics Group; each outstanding option to purchase shares of common stock of TransMedics was converted into an outstanding option to purchase shares of common stock of TransMedics Group adjusted on a 3.5-for-one basis, with a corresponding adjustment to the exercise price; and each outstanding warrant to purchase shares of preferred stock of TransMedics was converted into a warrant to purchase shares of common stock of TransMedics Group adjusted on a 3.5-for-one basis, with a corresponding adjustment to the exercise price. This is referred to as the “Corporate Reorganization.”

All share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the 3.5-for-one conversion ratio applied to common stock in the Corporate Reorganization.

Immediately following the Corporate Reorganization, (i) TransMedics Group became a holding company with no material assets other than 100% of the equity interests in TransMedics, (ii) the holders of capital stock in TransMedics became shareholders of TransMedics Group and (iii) the historical consolidated financial statements of TransMedics became the historical consolidated financial statements of TransMedics Group because the Corporate Reorganization was accounted for as a reorganization of entities under common control. Prior to the Corporate Reorganization, TransMedics Group had not conducted any activities other than in connection with its formation and in preparation for the IPO and had no material assets other than 100% of the equity interests in TMDX, Inc.

On May 6, 2019, the Company completed its IPO, pursuant to which it issued and sold 6,543,500 shares of common stock, inclusive of 853,500 shares sold by the Company pursuant to the full exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were $91.4 million, after deducting underwriting discounts and commissions as well as other offering costs of $6.0 million.

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 attributable to the Company of $24.4 million for the fiscal nine months ended September 28, 2019 and $23.8 million for the fiscal year ended December 29, 2018. As of September 28, 2019, the Company had an accumulated deficit of $360.3 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 $88.3 million as of September 28, 2019 will be sufficient to fund operations, capital expenditures, and debt service payments for at least the next twelve months following the filing of this Quarterly Report on Form 10-Q.

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. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any products will obtain necessary government regulatory approval or that any approved products will be commercially viable. The Company operates in an environment of rapid change in technology and competition from other medical device companies.

The Company’s fiscal year ends on the last Saturday in December, and the Company reports fiscal years using a 52/53-week convention. Under this convention, certain fiscal years contain 53 weeks. Each fiscal year is typically composed of four 13-week fiscal quarters, but in years with 53 weeks, the fourth quarter is a 14-week period. The fiscal year ended December 29, 2018 included 52 weeks and the fiscal year ending December 28, 2019 includes 52 weeks. The fiscal year ended December 29, 2018 is referred to as “fiscal 2018” and the fiscal year ended December 28, 2019 is referred to as “fiscal 2019.”

The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). 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.

Revision

Subsequent to the filing of its Form 10-Q for the quarterly period ended June 29, 2019, the Company discovered an error in the calculation of basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2018. The calculation of the weighted average number of common shares outstanding (basic and diluted) as originally reported had not appropriately reflected the 3.5-for-one conversion ratio applied to common stock in the Corporate Reorganization. The correction of this error decreased the weighted average number of common shares outstanding (basic and diluted) for the three and six months ended June 30, 2018 from 4,686,080 and 4,676,991, respectively, (as reported) to 1,338,880 and 1,336,283, respectively, (as revised). As a result, basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2018 increased from $1.30 and $2.36, respectively, (as reported) to $4.57 and $8.24, respectively, (as revised). Management of the Company has concluded that these revisions of basic and diluted net loss per share attributable to common stockholders are not material to the previously issued interim financial statements.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 28, 2019

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Unaudited Interim Financial Information

The consolidated balance sheet at December 29, 2018 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited consolidated financial statements as of September 28, 2019 and for the fiscal three and nine months ended September 28, 2019 and September 29, 2018 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 TransMedics’ audited consolidated financial statements and the notes thereto for the fiscal year ended December 29, 2018 included in the Company’s Registration Statement on Form S-1, as amended, File No. 333-230736 on file 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 28, 2019 and results of operations for the fiscal three and nine months ended September 28, 2019 and September 29, 2018 and cash flows for the fiscal nine months ended September 28, 2019 and September 29, 2018 have been made. The Company’s results of operations for the fiscal three and nine months ended September 28, 2019 are not necessarily indicative of the results of operations that may be expected for the fiscal year ending December 28, 2019.

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, the valuation of common stock, the valuation of stock-based awards and the valuation of the preferred stock warrant liability. 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. 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 has not experienced any other-than-temporary losses with respect to its cash, cash equivalents, and marketable securities and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Significant customers are those that accounted for 10% or more of the Company’s total revenue or accounts receivable (see Note 13).

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

Deferred Offering Costs

The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity (deficit) as a reduction of common stock generated as a result of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations. The Company recorded deferred offering costs of $3.4 million as of December 29, 2018. Upon closing of the IPO on May 6, 2019, these deferred offering costs were included in the $6.0 million issuance costs classified to stockholders’ equity (deficit) and recorded against the proceeds from the offering.

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 consisting of money market funds, U.S. Treasury securities, and U.S. government agency bonds and its preferred stock warrant liability 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 at each balance sheet date due to its variable interest rate, which approximates a market interest rate.

Marketable Securities

The Company’s marketable securities are classified as available-for-sale and are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit). Realized gains and losses and declines in value determined to be other than temporary are based on the specific identification method and are included as a component of other income (expense), net in the consolidated statements of operations.

The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge recorded in the consolidated statements of operations. No such adjustments were necessary during the periods presented.

Revenue Recognition

The Company generates revenue primarily from sales of its single-use, organ-specific disposable sets (i.e., its organ-specific OCS Perfusion Sets sold together with its organ-specific OCS Solutions) used on its organ-specific OCS Consoles, each being a component of the Company’s OCS products. To a lesser extent, the Company also generates revenue from the sale of OCS Consoles to customers and from the implied rental of OCS Consoles loaned to customers at no charge. For each new transplant procedure, customers purchase an additional OCS disposable set for use on the customer’s existing organ-specific OCS Console.

The Company recognizes revenue from sales to customers applying the following five steps: (1) identification of the contract, or contracts, with a customer, (2) identification of the performance obligations in the contract, (3) determination of the transaction price, (4) allocation of the transaction price to the performance obligations in the contract, and (5) recognition of revenue when, or as, performance obligations are satisfied. Because all performance obligations of a customer order are delivered and recognized as revenue at the same time and because revenue allocated to performance obligations other than OCS disposable sets, such as implied rental income and service revenue, is insignificant, all components of revenue from customer arrangements are classified as a single category of revenue in the Company’s consolidated statement of operations.

Substantially all of the Company’s customer contracts have multiple-performance obligations that contain deliverables consisting of OCS Perfusion Sets and OCS Solutions. In some of those customer contracts, the deliverables also include an OCS Console, whether sold or loaned to the customer. The Company evaluates each promise within a multiple-performance obligation arrangement to determine whether it represents a distinct performance obligation. A performance obligation is distinct if (1) the product or service is separately identifiable from other promises in the contract and (2) the customer can benefit from the product or service on its own or with other resources that are readily available to the customer.

When a customer order includes an OCS Console, whether sold or loaned, the Company has determined that customer training and the equipment set-up of the OCS Console, each performed by the Company, are not distinct because they are not sold on a standalone basis and can only be performed by the Company in conjunction with a sale or loan of its OCS Console. In addition, the Company has determined that the OCS Console itself is not distinct because the customer cannot benefit from the OCS Console without the training and equipment set-up having been completed. As a result, when the order includes an OCS Console, the Company has concluded that training, OCS Console equipment set-up, and the OCS Console itself are highly interdependent and represent a single, combined performance obligation. Consequently, the Company does not recognize any revenue from any component of a customer order that includes an OCS Console, whether sold or loaned, until the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by the Company. The Company has concluded that “transfer of control” of an OCS Console occurs only after the console has arrived at the customer site and the training and equipment set-up have been completed by the Company.

Some of the Company’s revenue has been generated from products sold in conjunction with the clinical trials conducted for the Company’s OCS products, under arrangements referred to as customer clinical trial agreements. Under most of these customer clinical trial agreements, the Company places an organ-specific OCS Console at the customer site for its use free of charge for the duration of the clinical trial, and the customer separately purchases from the Company the OCS disposable sets used in each transplant procedure during the clinical trial. When the Company loans the OCS Console to the customer, it retains title to the console at all times and does not require minimum purchase commitments from the customer related to any OCS products. In such cases, the Company invoices the customer for OCS disposable sets based on customer orders received for each new transplant procedure and the prices set forth in the customer agreement. Over time, the Company typically recovers the cost of the loaned OCS Console through the customer’s continued purchasing and use of additional OCS disposable sets. For these reasons, the Company has determined that part of the arrangement consideration for the disposable set is an implied rental payment for use of the OCS Console.

When the Company’s customer arrangements have multiple-performance obligations that contain a loan of an OCS Console for the customer’s use at its customer site as well as OCS disposable sets that are delivered simultaneously, the Company allocates the arrangement consideration between the lease deliverables (i.e., the OCS Console) and non-lease deliverables (i.e., the OCS disposable sets) based on the relative estimated standalone selling price (“SSP”) of each distinct performance obligation. To date, the amounts allocated to lease deliverables have been insignificant. In determining SSP, the Company maximizes observable inputs and consider a number of data points, including: (1) the pricing of standalone sales (in instances where available), (2) the pricing established by management when setting prices for deliverables that are intended to be sold on a standalone basis, (3) contractually stated prices for deliverables that are intended to be sold on a standalone basis, and (4) other pricing factors, such as the geographical region in which the products are sold and expected discounts based on the customer size and type.

Revenue is recognized when control of the OCS product or products is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for the product or products.

Performance Obligations

The primary performance obligations in the Company’s customer arrangements from which it derives revenue are as follows:

•

OCS Console — The OCS Console is a medical device that houses and controls the function of the OCS. The performance obligation of the OCS Console includes customer training and equipment set-up. Revenue for each OCS Console is recognized at the point in time at which control is transferred to the customer, which is typically only after the console has arrived at the customer site and the training and equipment set-up have been completed by the Company because the customer cannot benefit from the OCS Console without the training and equipment set-up having been completed. At that time, the Company believes that the customer has the significant risks and rewards of ownership.

•

OCS Perfusion Set — The OCS Perfusion Set is a single-use disposable set that stores the organ and circulates blood. Revenue for each OCS Perfusion Set is recognized at the point in time at which control is transferred to the customer, which is when title transfers to the customer in connection with delivery. In most of the Company’s customer arrangements, title to the OCS Perfusion Set transfers when the OCS Perfusion Set arrives at the customer site. In limited instances, title transfers upon shipment to the customer by the Company.

•

OCS Solutions — The OCS Solutions are a set of nutrient-enriched solutions to optimize the organ’s condition outside the human body. Revenue for each OCS Solution is recognized at the point in time at which control is transferred to the customer, which is when title transfers to the customer in connection with delivery. In most of the Company’s customer arrangements, title to the OCS Solutions transfers when the OCS Solutions arrive at the customer site. In limited instances, title transfers upon shipment to the customer by the Company.

Payments Made to Customers

Under the Company’s customer arrangements that include a customer clinical trial agreement, the Company receives payments from sales to the customer of its OCS products and also makes payments to that customer for reimbursements of clinical trial costs, materials, and for specified clinical documentation related to the customer’s use of its OCS products. The Company also makes payments to customers involved in post-approval studies for information related to the transplant procedures performed. The Company determines the appropriate accounting treatments for these payments depending on the nature of the payment and whether they are for distinct goods or services.

In these cases, 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, the Company has determined that 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 Company recorded the reimbursable clinical costs as a reduction of revenue of $0.7 million and $1.8 million, for the fiscal three and nine months ended September 28, 2019, respectively, and $0.7 million and $1.3 million for the fiscal three and nine months ended September 29, 2018, respectively, as presented below in disaggregated revenue.

The Company has also 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) do 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 represents the fair value of the distinct good or service received by the Company. As a result, these payments made to the customers for information related to post-approval studies or standard-of-care protocols are recorded as research, development, and clinical trials 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 $0.9 million for the fiscal three and nine months ended September 28, 2019, respectively, and $0.2 million and $0.3 million for the fiscal three and nine months ended September 29, 2018, respectively, as research, development, and clinical trials expenses.

Variable Consideration

Revenue is reported net of any taxes assessed by a governmental authority that are directly imposed on a revenue-producing transaction (e.g., sales, use, and value added taxes). The Company only includes estimated variable amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.

Revenue from reimbursements of out-of-pocket expenses, including travel, lodging, and meals, is accounted for as variable consideration.

The Company does not consider shipping to be a contract performance obligation. The Company records shipping costs billed to customers as revenue and records the associated costs incurred by the Company for those items as cost of revenue.

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. Payment terms for customer orders, including for each of the Company’s primary performance obligations, are typically 30 days for customers in the United States and 30 to 90 days for customers in non-U.S. markets, and such payments do not include payments that are variable, dependent on specified factors or events.

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 28, 2019 and December 29, 2018.

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 28, 2019, and December 29, 2018, the Company’s wholly- or partially-unsatisfied performance obligations totaled $0.3 million and $1.5 million, respectively.

Disaggregated Revenue

In determining total net revenue under the revenue recognition guidance applicable to both periods presented, the Company reduces revenue by the amount of certain payments made to customers (see “Payments Made to Customers” above). The reconciliation of gross revenue to net revenue for these certain payments is shown below (in thousands):

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Gross revenue from sales to customers	$	7,876	$	4,755	$	19,381	$	10,776
Less: Clinical trial payments reducing revenue		671		716		1,834		1,303
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

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):

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by OCS product:
OCS Lung net revenue	$	2,114	$	1,487	$	5,744	$	3,146
OCS Heart net revenue		3,739		1,639		8,305		4,860
OCS Liver net revenue		1,352		913		3,498		1,467
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by geography:
United States	$	4,341	$	2,244	$	11,596	$	4,391
Outside the U.S.		2,864		1,795		5,951		5,082
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

Practical Expedients Used in Application of ASC 606

The Company has elected to apply the practical expedient for immaterial goods and services in the context of the contract. Accordingly, the Company does not assess whether promised goods or services are performance obligations if they are deemed immaterial in the context of the contract with the customer.

The Company has elected to apply the practical expedient for shipping. Accordingly, the Company does not consider shipping to be a contract performance obligation.

When applicable, the Company has elected to apply the practical expedient for considering the existence of a significant financing component. Accordingly, the Company does not adjust the promised amount of arrangement consideration for the effects of a significant financing component if it expects, at contract inception, that the period of time between the Company’s transfer of a promised good or service to a customer and the customer’s payment for that good or service will be one year or less.

Distributors

The Company markets and sells its products primarily through its direct sales force, which sells its products to end customers globally. A small portion of the Company’s revenue is generated by sales to a limited number of distributors in Europe and Asia-Pacific. When the Company transacts with a distributor, its contractual arrangement is with the distributor and not with the end customer. Whether the Company transacts business with and receives the order from a distributor or directly from an end customer, its revenue recognition policy and resulting pattern of revenue recognition for the order are the same.

In its business with distributors, the Company enters into a distributor agreement under which the distributor places orders to the Company for its products in connection with the distributor’s own sales to identified end customers, and the Company confirms the identification of the end customer prior to accepting each order. The Company’s distributors do not stock OCS Consoles purchased from the Company and stock only minimal quantities of OCS disposable sets. Under these contractual arrangements, the Company invoices the distributor for the selling price (which reflects a distributor discount relative to typical end customer pricing) and payment to the Company from the distributor is not contingent upon the distributor’s collection from the end customer. The Company records revenue based on the amount of the discounted selling price.

When a sale to a distributor includes an OCS Console, the Company performs the training and OCS Console equipment set-up for the end customer. The Company recognizes no revenue from a distributor order that includes an OCS Console until the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by the Company.

Stock-Based Compensation

The Company measures stock-based option awards granted to employees, non-employees and directors based on their fair value on the date of grant using the Black-Scholes option-pricing model. Compensation expense for those awards is recognized over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues awards with only service-based vesting conditions and records the expense for these awards using the straight-line method.

Prior to the adoption of Accounting Standards Update (“ASU”) 2018-07 on December 30, 2018 discussed below, the Company measured the fair value of stock-based option awards granted to non-employee consultants on the date that the related service was complete, which was generally the vesting date. Prior to the service completion date, compensation expense was recognized over the period during which services were rendered by such non-employee consultants. At the end of each financial reporting period prior to completion of the service, the fair value of these awards was remeasured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option-pricing model.

The Company classifies stock-based compensation expense in its consolidated statements of operations in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing and 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

Prior to closing of the IPO, the Company followed the two-class method when computing net income (loss) per share, as TransMedics had issued shares that meet the definition of participating securities. The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.

Basic net income (loss) per share attributable to common stockholders is computed by dividing the net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net income (loss) attributable to common stockholders is computed by adjusting net income (loss) attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net income (loss) per share attributable to common stockholders is computed by dividing the diluted net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents.

The outstanding convertible preferred stock contractually entitled the holders of such shares to participate in dividends but did not contractually require the holders of such shares to participate in losses of the Company. Accordingly, in periods in which the Company reports a net loss, such losses are not allocated to such participating securities. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

Subsequent to the closing of its IPO, the Company only has one class of shares outstanding and 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 fiscal three and nine months ended September 28, 2019 and September 29, 2018.

Recently Adopted Accounting Pronouncements

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASC 606”). ASC 606 outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry specific guidance. The new standards require entities to apportion consideration from contracts to performance obligations on a relative standalone selling price basis, based on a five-step model. Under ASC 606, revenue is recognized when a customer obtains control of a promised good or service and is recognized in an amount that reflects the consideration that the entity expects to receive in exchange for the good or service. In addition, ASC 606 provides guidance on accounting for certain revenue related costs, including costs associated with obtaining and fulfilling a contract. The Company adopted ASC 606 on December 30, 2018, applied using the modified retrospective method. Under this method, (i) the new guidance is applied to customer contracts that are not yet completed as of December 29, 2018, with the cumulative effect of initially applying the new guidance recorded as an adjustment to accumulated deficit on the effective date of adoption, and (ii) the Company’s historical results for all periods prior to December 30, 2018, including for the fiscal three and nine months ended September 29, 2018, are not adjusted. The Company did not elect to apply any permitted practical expedients as part of its adoption.

The Company’s adoption of ASC 606 did not substantially change the revenue recognition of its OCS products as applied under the prior revenue guidance, ASC 605, and, as a result, the adoption did not have a material impact on the Company’s consolidated financial statements. Accordingly, transitional disclosures were not presented. The Company’s revenue accounting policies related to ASC 605, which were applied in its reporting of amounts presented for all periods prior to December 30, 2018, were unchanged.

In June 2018, the FASB issued ASU No. 2018-07, Compensation – Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. For public entities, ASU 2018-07 was required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. For nonpublic entities, ASU 2018-07 is effective for annual periods beginning after December 15, 2019. Early adoption is permitted for all entities but no earlier than the Company’s adoption of ASU 2014-09. The Company early-adopted ASU 2018-07 on December 30, 2018 and the adoption did not have a material impact on the Company’s financial statements.

Recently Issued Accounting Pronouncements

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which sets out the principles for the recognition, measurement, presentation, and disclosure of leases for both parties to a contract (i.e., lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less may be accounted for similar to existing guidance for operating leases today. For public entities, the guidance has been effective for annual reporting periods beginning after December 15, 2018 and for interim periods within those fiscal years. For nonpublic entities, the guidance is effective for annual reporting periods beginning after December 15, 2019 and for interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted for all entities. ASU 2016-02 initially required adoption using a modified retrospective approach, under which all years presented in the financial statements would be prepared under the revised guidance. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842), which added an optional transition method under which financial statements may be prepared under the revised guidance for the year of adoption, but not for prior years. Under the latter method, entities will recognize a cumulative catch-up adjustment to the opening balance of retained earnings in the period of adoption. In October 2019, the FASB formally approved the new effective date for ASC 842 for nonpublic entities. Accordingly, for nonpublic entities, the guidance is effective for annual reporting periods beginning after December 15, 2020 and for interim periods within fiscal years beginning after December 15, 2021. The Company will adopt ASU 2016-02 in its fiscal year 2021, which begins on December 27, 2020, in accordance with the nonpublic company requirements. The Company is currently evaluating the method of adoption of this guidance and the impact that the adoption of ASU 2016-02 will have on its consolidated financial statements.

Marketable Securities

9 Months Ended

Sep. 28, 2019

Investments Debt And Equity Securities [Abstract]

Marketable Securities

3. Marketable Securities

The Company invests its excess cash in fixed income instruments denominated and payable in U.S. dollars, including U.S. treasury securities and U.S. government agency bonds in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital.

The Company has designated investments as available-for-sale and therefore such investments are reported at fair value. Unrealized gains or losses on investments are recorded in accumulated other comprehensive income or loss, a component of stockholders’ equity (deficit), on the Company’s consolidated balance sheets.

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

	September 28, 2019
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. Treasury securities	$	12,218	$	3	$	—	$	12,221
U.S. Government agency bonds		55,595		49		—		55,644
	$	67,813	$	52	$	—	$	67,865

The Company’s marketable securities are due within one year. The Company had no marketable securities as of December 29, 2018.

Fair Value of Financial Assets and Liabilities

9 Months Ended

Sep. 28, 2019

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 28, 2019 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	12,126	$	—	$	—	$	12,126
Marketable securities:
U.S Treasury securities		—		12,221		—		12,221
U.S. Government agency bonds		—		55,644		—		55,644
	$	12,126	$	67,865	$	—	$	79,991

	Fair Value Measurements at Year Ended December 29, 2018 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	13,586	$	—	$	—	$	13,586
	$	13,586	$	—	$	—	$	13,586
Liabilities:
Preferred stock warrant liability	$	—	$	—	$	898	$	898

Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. During the fiscal nine months ended September 28, 2019 and September 29, 2018, there were no transfers between Level 1, Level 2, and Level 3.

The preferred stock warrant liability in the table above consisted of the fair value of warrants to purchase Series D and Series F convertible preferred stock (see Note 8) and was based on significant inputs not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The Company’s valuation of the preferred stock warrants utilized the Black-Scholes option-pricing model, which incorporated assumptions and estimates to value the preferred stock warrants. The Company assessed these assumptions and estimates on a quarterly basis as additional information impacting the assumptions was obtained. Changes in the fair value of the preferred stock warrants were recognized as other income (expense), net in the consolidated statement of operations. On May 6, 2019, immediately prior to the closing of the IPO, the warrants to purchase preferred stock were converted into warrants to purchase common stock, and the fair value of the warrant liability at that time was reclassified to common stock. As a result, subsequent to the closing of the IPO, the Company no longer remeasures the fair value of the warrant liability at each reporting date.

The quantitative elements associated with the Company’s Level 3 inputs impacting the fair value measurement of the preferred stock warrant liability included the fair value per share of the underlying Series D and Series F convertible preferred stock, the remaining contractual term of the warrants, risk-free interest rate, expected dividend yield and expected volatility of the price of the underlying preferred stock. The most significant assumption in the Black-Scholes option-pricing model that impacted the fair value of the preferred stock warrants was the fair value of the Company’s convertible preferred stock as of each remeasurement date. The Company determined the fair value per share of the underlying preferred stock by taking into consideration the most recent sales of its convertible preferred stock, results obtained from third-party valuations and additional factors that the Company deemed relevant. As of December 29, 2018, the fair value of each share of Series D and Series F convertible preferred stock was $6.21 per share and $5.73 per share, respectively. Prior to its IPO, the Company historically had been a private company and lacked company-specific historical and implied volatility information of its stock. Therefore, it estimated its expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrants. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company had estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company had never paid or declared dividends.

Based on the terms and conditions of the warrants and pursuant to the Corporate Reorganization, immediately prior to the closing of the Company’s IPO on May 6, 2019, the preferred stock warrants converted to common stock warrants. On that date, the Company remeasured the warrants and reclassified the total carrying value to stockholders’ equity (deficit). The Company performed the final measurement of the warrants using the fair value of the underlying common shares of $27.41 per share on May 6, 2019 and recorded the change in fair value in other income (expense), net in the consolidated statement of operations.

The following table provides a roll-forward of the aggregate fair values of the Company’s preferred stock warrants for which fair value is determined by Level 3 inputs (in thousands):

	Preferred Stock Warrant Liability
Fair value at December 29, 2018	$	898
Change in fair value		341
Reclassification of warrant liability to equity upon initial public offering		(1,239	)
Fair value at September 28, 2019	$	—

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

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 28, 2019

Accrued Expenses and Other Current Liabilities

5. Accrued Expenses and Other Current Liabilities

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

	September 28, 2019		December 29, 2018
Accrued research, development and clinical trials expenses	$	3,072	$	1,853
Accrued payroll and related expenses		3,515		1,729
Accrued financing fees (Note 10)		340		1,466
Accrued professional fees		837		549
Accrued premium for manufacturing contract		—		1,089
Accrued other		1,584		492
	$	9,348	$	7,178

Inventory

9 Months Ended

Sep. 28, 2019

Inventory Disclosure [Abstract]

Inventory

6. Inventory

Inventory consisted of the following (in thousands):

	September 28, 2019		December 29, 2018
Raw materials	$	4,665	$	3,817
Work-in-process		924		882
Finished goods		4,947		4,578
	$	10,536	$	9,277

During the fiscal nine months ended September 28, 2019 and September 29, 2018, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $1.9 million and $1.2 million, respectively.

Long-Term Debt

9 Months Ended

Sep. 28, 2019

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. As of September 28, 2019, and December 29, 2018, long-term debt consisted of the following (in thousands):

	September 28, 2019			December 29, 2018
Principal amount of long-term debt	$	35,000		$	35,000
Debt discount, net of accretion		(1,213	)		(1,424	)
Accrued end-of-term payment		236			94
Long-term debt, net of discount	$	34,023		$	33,670

Borrowings under the Credit Agreement bear interest at an annual rate equal to the London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0% and a maximum of 4.0%, plus 8.5% (the “Applicable Margin”), subject in the aggregate to a maximum interest rate of 11.5%. In addition, borrowings under the Credit Agreement bear paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeds 11.5%, but not to exceed 12.5%. The PIK interest is added to the principal amount of the borrowings outstanding at the end of each quarter until the maturity date of the Credit Agreement in June 2023. Borrowings under the Credit Agreement are repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest is due and payable. At its option, the Company may prepay outstanding borrowings under the Credit Agreement, subject to a prepayment premium of 9.0% of the principal amount of any prepayment within the first three years, which percentage decreases annually until it reaches zero at the end of three years. The Company is also required to make a final payment in an amount equal to 3.0% of the principal amount of any prepayment or repayment. The final payment and debt discount amounts are being accreted to interest expense over the term of the Credit Agreement using the effective interest method.

All obligations under the Credit Agreement are guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor are secured by substantially all of the Company’s and each guarantor’s assets, including their intellectual property, subject to certain exceptions, including a perfected security interest in substantially all tangible and intangible assets of the Company and each guarantor. Under the Credit Agreement, the Company has agreed to certain affirmative and negative covenants to which it will remain subject until maturity. The covenants include maintaining a minimum liquidity amount of $3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from the Company’s independent registered public accounting firm; and restrictions on the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. With respect to its consolidated financial statements for the fiscal year ended December 29, 2018, the Company received a waiver of the covenant requiring delivery to OrbiMed of audited financial statements with an unqualified audit opinion. As of September 28, 2019, the Company was in compliance with the minimum liquidity covenant of the Credit Agreement.

The obligations under the Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in the Company’s business), failure to comply with certain covenants, including the minimum liquidity and unqualified audit opinion covenants, and a material adverse change in the Company’s business, operations or other financial condition.

Upon the occurrence of an event of default and until such event of default is no longer continuing, the Applicable Margin will increase by 4.0% per annum. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, OrbiMed may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, the Company may be required to prepay outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.

As of September 28, 2019, the interest rate applicable to borrowings under the Credit Agreement was 11.3%. During the fiscal nine months ended September 28, 2019, the weighted average effective interest rate on outstanding borrowings under the Credit Agreement was approximately 12.9%.

Convertible Preferred Stock and Warrants to Purchase Preferred Stock

9 Months Ended

Sep. 28, 2019

Convertible Preferred Stock And Warrants To Purchase Preferred Stock [Abstract]

Convertible Preferred Stock and Warrants to Purchase Preferred Stock

8. Convertible Preferred Stock and Warrants to Purchase Preferred Stock

Convertible Preferred Stock

TransMedics issued Series A-1 convertible preferred stock (the “Series A-1 Preferred Stock”), Series B convertible preferred stock (the “Series B Preferred Stock”), Series B-1 convertible preferred stock (the “Series B-1 Preferred Stock”), Series C convertible preferred stock (the “Series C Preferred Stock”), Series D convertible preferred stock (the “Series D Preferred Stock”), Series E convertible preferred stock (the “Series E Preferred Stock”) and Series F convertible preferred stock (the “Series F Preferred Stock”).

As of December 29, 2018, preferred stock consisted of the following (in thousands, except share amounts):

	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value		Liquidation Preference		Common Stock Issuable Upon Conversion
Series A-1 Preferred Stock		13,332		13,332	$	3,333	$	33		984
Series B Preferred Stock		3,771,020		3,624,650		10,691		12,382		286,102
Series B-1 Preferred Stock		2,560,245		2,560,245		8,746		8,746		202,086
Series C Preferred Stock		6,198,057		6,198,057		14,970		15,495		1,770,873
Series D Preferred Stock		14,740,000		14,565,000		34,868		72,825		4,161,428
Series E Preferred Stock		6,562,232		6,562,232		29,865		29,966		1,874,923
Series F Preferred Stock		16,931,168		16,880,624		84,046		84,234		4,823,028
		50,776,054		50,404,140	$	186,519	$	223,681		13,119,424

Immediately prior to the closing of the IPO on May 6, 2019, pursuant to the Corporate Reorganization, all of the outstanding shares of convertible preferred stock of TransMedics were converted into an aggregate of 13,119,424 shares of common stock of TransMedics Group.

Warrants to Purchase Preferred Stock

In connection with prior debt agreements and amendments to such agreements, TransMedics had outstanding warrants to purchase shares of Series D Preferred Stock and Series F Preferred Stock as of December 29, 2018. The Company classified all of its preferred stock warrants as a liability on its consolidated balance sheets because the warrants were freestanding financial instruments that could require TransMedics to transfer assets upon exercise. The liability associated with each of these warrants was initially recorded at fair value upon the issuance date of each warrant and subsequently remeasured to fair value at each reporting date. The fair value of these warrants was determined using the Black-Scholes option-pricing model (see Note 4), and the resulting change in fair value of the warrant liability was recorded in other income (expense) in the Company’s consolidated statements of operations (see Note 4).

Immediately prior to the closing of the IPO on May 6, 2019, pursuant to the Corporate Reorganization, all of the outstanding preferred stock warrants of TransMedics were converted into warrants to purchase an aggregate of 64,440 shares of common stock of TransMedics Group at a weighted average exercise price of $10.70 per share and an expiration date of May 6, 2024. Upon conversion, the fair value of the warrant liability at that time was reclassified to common stock. As a result, subsequent to the closing of the Company’s IPO, the Company will no longer remeasure the fair value of the warrant liability at each reporting date.

Stock-Based Compensation

9 Months Ended

Sep. 28, 2019

Stockholders Equity Note [Abstract]

Stock-Based Compensation

9. Stock-Based Compensation

2014 Stock Incentive Plan

The Company’s 2014 Stock Incentive Plan (the “2014 Plan”) permitted the Company to sell or issue incentive stock options or nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards to employees, directors, and non-employee consultants of the Company. The 2014 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting, and other restrictions were determined at the discretion of the board of directors, or its committee if so delegated.

Stock options granted under the 2014 Plan with service-based vesting conditions typically vest over three or four years and expire after ten years. Following the effectiveness of the Company’s 2019 Stock Incentive Plan (the “2019 Stock Plan”) in April 2019, no future awards will be made under the 2014 Plan. Additionally, shares underlying awards under the 2014 Plan that expire or are terminated, surrendered, or canceled without the delivery of shares will be available for future awards under the 2019 Stock Plan.

2019 Stock Incentive Plan and Option Grants

On April 15, 2019, TransMedics Group’s board of directors adopted and its sole stockholder approved the 2019 Stock Plan, which became effective on that same date. The 2019 Stock 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 Stock Plan was 3,428,571 shares, plus the number of shares underlying awards under 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 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 Stock Plan. In addition, the number of shares available for issuance under the 2019 Stock Plan (i) will not be increased by any shares delivered under the 2019 Stock 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 Stock Plan. As of September 28, 2019, 2,987,866 shares of common stock were available for issuance under the 2019 Plan.

During the fiscal nine months ended September 28, 2019, the Company granted options to its employees and a director with service-based vesting for the purchase of an aggregate of 457,357 shares of common stock with a weighted average grant fair value of $8.54 per share.

2019 Employee Stock Purchase Plan

On April 15, 2019, TransMedics Group’s board of directors adopted and its sole stockholder approved the 2019 Employee Stock Purchase Plan (the “2019 ESPP”), which became effective that same date. A total of 371,142 shares of common stock of TransMedics Group are reserved for issuance under the 2019 ESPP as of September 28, 2019. As of September 28, 2019, no shares have been issued under the 2019 ESPP and 371,142 shares remained available for issuance.

Stock-Based Compensation

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

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Cost of revenue	$	6	$	1	$	14	$	4
Research, development and clinical trials expenses		35		9		67		28
Selling, general and administrative expenses		254		21		491		60
	$	295	$	31	$	572	$	92

As of September 28, 2019, total unrecognized compensation cost related to unvested share-based awards was $4.0 million which is expected to be recognized over a weighted average period of 2.96 years.

Commitments and Contingencies

9 Months Ended

Sep. 28, 2019

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingencies

10. Commitments and Contingencies

Operating Leases

The Company leases its office, laboratory, and manufacturing space under two noncancelable operating leases that expire in December 2021. The lease agreements include payment escalations, rent holidays, and other lease incentives, which are accrued or deferred as appropriate such that rent expense for each lease is recognized on a straight-line basis over the respective lease terms, recording deferred rent for rent expense incurred but not yet paid. The Company recorded rent expense of $0.3 million and $1.0 million in each of the fiscal three and nine months ended September 28, 2019 and September 29, 2018, respectively.

Future minimum lease payments under operating leases as of September 28, 2019 are as follows (in thousands):

Fiscal Year Ending:
December 28, 2019 (remaining 3 months)	$	388
December 26, 2020		1,570
December 25, 2021		1,589
	$	3,547

License Agreement with the Department of Veterans Affairs

The Company has a license agreement with the Department of Veterans Affairs (the “VA”), entered into in 2002, under which the Company was granted an exclusive, worldwide license under specified patents to make, use, sell, and import certain technology used in the Company’s products and a non-exclusive, worldwide license to make, use, sell, and import solutions for use in or with those products. The rights under the license agreement continue until the expiration of the last to expire of the licensed patents. The majority of the licensed U.S. patents expired in 2017, and the foreign patents expired in September 2018. However, the Company has requested a patent term extension for one U.S. patent covered by the VA license agreement, U.S. Patent No. 6,100,082. The Company has been granted an interim patent term extension for this patent. As of September 28, 2019, the Company had not received final approval of the patent extension beyond the interim patent term extension until September 23, 2020 already granted. The maximum extension granted would be through May 2022; however, the length of the patent term extension will be determined by the United States Patent and Trademark Office. The license includes the right to grant sublicenses, subject to approval by the VA and other restrictions, and is subject to the U.S. government’s right to practice the licensed patents on its own behalf without payment of a royalty and obligation to grant certain sublicenses as necessary to fulfill public health, welfare, and safety needs. The license agreement also requires the Company to make its products covered by the licensed patents available to the public on reasonable terms and to provide the U.S. government such products at the lowest price.

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

The VA license agreement can be terminated by the Company or the VA only if the other party fails to cure its material breach within a specified period after receiving notice of such breach.

Accrued Financing Fees

In periods prior to 2016, the Company incurred financing fees of $1.5 million for amounts due to its former financial advisors related to the issuance of its Series B Preferred Stock and Series D Preferred Stock. These financing fees were contingently payable in cash only upon an IPO or certain alternative transactions, including a sale of the Company. As a result of the IPO in May 2019, the Company became obligated to pay those financing fees, of which $1.0 million was paid in the fiscal three months ended September 28, 2019 and $0.3 million was accrued as of September 28, 2019. The difference between the amount previously accrued of $1.5 million and the final payment $1.3 million were recorded to stockholders’ equity (deficit) in the three and nine fiscal months ended September 28, 2019 (see Note 5).

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 28, 2019, and December 29, 2018, 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 28, 2019 or December 29, 2018.

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.

Net Loss per Share

9 Months Ended

Sep. 28, 2019

Earnings Per Share [Abstract]

Net Loss per Share

11. Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

	Fiscal Three Months Ended						Fiscal Nine Months Ended
	September 28, 2019			September 29, 2018			September 28, 2019			September 29, 2018
Numerator:
Net loss attributable to common stockholders	$	(8,280	)	$	(5,105	)	$	(24,370	)	$	(16,121	)
Denominator:
Weighted average common shares outstanding, basic and diluted		21,131,618			1,368,260			11,882,626			1,346,942
Net loss per share attributable to common stockholders, basic and diluted	$	(0.39	)	$	(3.73	)	$	(2.05	)	$	(11.97	)

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:

	September 28, 2019		September 29, 2018
Convertible preferred stock (as converted to common stock)		—		13,119,424
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		1,969,392		1,538,619
		2,033,832		14,722,483

Segment Reporting and Geographic Data

9 Months Ended

Sep. 28, 2019

Segment Reporting [Abstract]

Segment Reporting and Geographic Data

12. Segment Reporting and Geographic Data

The Company has determined that it operates in one segment (see Note 2). Financial data by geographical area is summarized as follows (in thousands):

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue⁽¹⁾:
United States	$	4,341	$	2,244	$	11,596	$	4,391
United Kingdom		773		937		1,747		2,049
Germany		194		252		871		1,098
Australia		251		167		561		987
All other countries		1,646		439		2,772		948
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

	September 28, 2019		December 29, 2018
Long-lived assets⁽²⁾:
United States	$	3,906	$	2,567
Netherlands		840		907
Total long-lived assets	$	4,746	$	3,474

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

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

Significant Customer Concentrations

9 Months Ended

Sep. 28, 2019

Risks And Uncertainties [Abstract]

Significant Customer Concentrations

13. Significant Customer Concentrations

Significant customers are those that accounted for 10% or more of the Company’s net revenue or accounts receivable, as set forth in the following tables for the periods presented:

Net revenue:

Fiscal Three Months Ended

Fiscal Nine Months Ended

September 28, 2019

September 29, 2018

September 28, 2019

September 29, 2018

Company A

Company B

Company C

Company D

*	Less than 10% of total

Accounts receivable:

	September 28, 2019	December 29, 2018
Company A	*	15%
Company B	*	13%

*	Less than 10% of total

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 28, 2019

Unaudited Interim Financial Information

Use of Estimates

Risk of Concentrations of Credit, Significant Customers and Significant Suppliers

Significant customers are those that accounted for 10% or more of the Company’s total revenue or accounts receivable (see Note 13).

Deferred Offering Costs

Fair Value Measurements

•

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

•

Marketable Securities

Revenue Recognition

Performance Obligations

The primary performance obligations in the Company’s customer arrangements from which it derives revenue are as follows:

•

Payments Made to Customers

Variable Consideration

Revenue from reimbursements of out-of-pocket expenses, including travel, lodging, and meals, is accounted for as variable consideration.

Contract Assets and Liabilities

Disaggregated Revenue

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Gross revenue from sales to customers	$	7,876	$	4,755	$	19,381	$	10,776
Less: Clinical trial payments reducing revenue		671		716		1,834		1,303
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by OCS product:
OCS Lung net revenue	$	2,114	$	1,487	$	5,744	$	3,146
OCS Heart net revenue		3,739		1,639		8,305		4,860
OCS Liver net revenue		1,352		913		3,498		1,467
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by geography:
United States	$	4,341	$	2,244	$	11,596	$	4,391
Outside the U.S.		2,864		1,795		5,951		5,082
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

Practical Expedients Used in Application of ASC 606

The Company has elected to apply the practical expedient for shipping. Accordingly, the Company does not consider shipping to be a contract performance obligation.

Distributors

Stock-based Compensation

Stock-Based Compensation

Segment Information

Net Income (Loss) per Share

Recently Adopted Accounting Pronouncements

Recently Issued Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 28, 2019

Schedule of Recognized Revenue Net of Payments

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

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Gross revenue from sales to customers	$	7,876	$	4,755	$	19,381	$	10,776
Less: Clinical trial payments reducing revenue		671		716		1,834		1,303
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

Schedule of Net revenue by OCS product

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by OCS product:
OCS Lung net revenue	$	2,114	$	1,487	$	5,744	$	3,146
OCS Heart net revenue		3,739		1,639		8,305		4,860
OCS Liver net revenue		1,352		913		3,498		1,467
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue by geography:
United States	$	4,341	$	2,244	$	11,596	$	4,391
Outside the U.S.		2,864		1,795		5,951		5,082
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

Marketable Securities (Tables)

9 Months Ended

Sep. 28, 2019

Investments Debt And Equity Securities [Abstract]

Components of Marketable Securities by Security Type

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

	September 28, 2019
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. Treasury securities	$	12,218	$	3	$	—	$	12,221
U.S. Government agency bonds		55,595		49		—		55,644
	$	67,813	$	52	$	—	$	67,865

Fair Value of Financial Assets and Liabilities (Tables)

9 Months Ended

Sep. 28, 2019

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 28, 2019 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	12,126	$	—	$	—	$	12,126
Marketable securities:
U.S Treasury securities		—		12,221		—		12,221
U.S. Government agency bonds		—		55,644		—		55,644
	$	12,126	$	67,865	$	—	$	79,991

	Fair Value Measurements at Year Ended December 29, 2018 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	13,586	$	—	$	—	$	13,586
	$	13,586	$	—	$	—	$	13,586
Liabilities:
Preferred stock warrant liability	$	—	$	—	$	898	$	898

Schedule of Fair Value Adjustment For Preferred Stock Warrants And Rights outstanding

The following table provides a roll-forward of the aggregate fair values of the Company’s preferred stock warrants for which fair value is determined by Level 3 inputs (in thousands):

	Preferred Stock Warrant Liability
Fair value at December 29, 2018	$	898
Change in fair value		341
Reclassification of warrant liability to equity upon initial public offering		(1,239	)
Fair value at September 28, 2019	$	—

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 28, 2019

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 28, 2019		December 29, 2018
Accrued research, development and clinical trials expenses	$	3,072	$	1,853
Accrued payroll and related expenses		3,515		1,729
Accrued financing fees (Note 10)		340		1,466
Accrued professional fees		837		549
Accrued premium for manufacturing contract		—		1,089
Accrued other		1,584		492
	$	9,348	$	7,178

Inventory (Tables)

9 Months Ended

Sep. 28, 2019

Inventory Disclosure [Abstract]

Schedule of Inventory, Current

Inventory consisted of the following (in thousands):

	September 28, 2019		December 29, 2018
Raw materials	$	4,665	$	3,817
Work-in-process		924		882
Finished goods		4,947		4,578
	$	10,536	$	9,277

Long-term Debt (Tables)

9 Months Ended

Sep. 28, 2019

Debt Disclosure [Abstract]

Schedule of Long-term Debt Instruments

As of September 28, 2019, and December 29, 2018, long-term debt consisted of the following (in thousands):

	September 28, 2019			December 29, 2018
Principal amount of long-term debt	$	35,000		$	35,000
Debt discount, net of accretion		(1,213	)		(1,424	)
Accrued end-of-term payment		236			94
Long-term debt, net of discount	$	34,023		$	33,670

Convertible Preferred Stock And Warrants To Purchase Preferred Stock [Abstract]

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.

+ References

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+ Details

Convertible Preferred Stock and Warrants to Purchase Preferred Stock (Tables)

9 Months Ended

Sep. 28, 2019

Schedule of Preferred Stock

As of December 29, 2018, preferred stock consisted of the following (in thousands, except share amounts):

	Preferred Stock Authorized		Preferred Stock Issued and Outstanding		Carrying Value		Liquidation Preference		Common Stock Issuable Upon Conversion
Series A-1 Preferred Stock		13,332		13,332	$	3,333	$	33		984
Series B Preferred Stock		3,771,020		3,624,650		10,691		12,382		286,102
Series B-1 Preferred Stock		2,560,245		2,560,245		8,746		8,746		202,086
Series C Preferred Stock		6,198,057		6,198,057		14,970		15,495		1,770,873
Series D Preferred Stock		14,740,000		14,565,000		34,868		72,825		4,161,428
Series E Preferred Stock		6,562,232		6,562,232		29,865		29,966		1,874,923
Series F Preferred Stock		16,931,168		16,880,624		84,046		84,234		4,823,028
		50,776,054		50,404,140	$	186,519	$	223,681		13,119,424

Schedule of stock-based compensation expense

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(28))
-URI http://asc.fasb.org/extlink&oid=6877327&loc=d3e13212-122682

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21553-112644

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Topic 480
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-URI http://asc.fasb.org/extlink&oid=65877616&loc=d3e177068-122764

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 11: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
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+ Details

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 28, 2019

Stockholders Equity Note [Abstract]

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

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Cost of revenue	$	6	$	1	$	14	$	4
Research, development and clinical trials expenses		35		9		67		28
Selling, general and administrative expenses		254		21		491		60
	$	295	$	31	$	572	$	92

Net Loss per Share (Tables)

9 Months Ended

Sep. 28, 2019

Earnings Per Share [Abstract]

Schedule of Basic and diluted net loss per share attributable to common stockholders

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

	Fiscal Three Months Ended						Fiscal Nine Months Ended
	September 28, 2019			September 29, 2018			September 28, 2019			September 29, 2018
Numerator:
Net loss attributable to common stockholders	$	(8,280	)	$	(5,105	)	$	(24,370	)	$	(16,121	)
Denominator:
Weighted average common shares outstanding, basic and diluted		21,131,618			1,368,260			11,882,626			1,346,942
Net loss per share attributable to common stockholders, basic and diluted	$	(0.39	)	$	(3.73	)	$	(2.05	)	$	(11.97	)

Schedule of computation of diluted net loss per share attributable to common stockholders

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:

	September 28, 2019		September 29, 2018
Convertible preferred stock (as converted to common stock)		—		13,119,424
Warrants to purchase common stock		64,440		64,440
Options to purchase common stock		1,969,392		1,538,619
		2,033,832		14,722,483

Segment Reporting and Geographic Data (Tables)

9 Months Ended

Sep. 28, 2019

Segment Reporting [Abstract]

Schedule of Financial data by geographical area

The Company has determined that it operates in one segment (see Note 2). Financial data by geographical area is summarized as follows (in thousands):

	Fiscal Three Months Ended				Fiscal Nine Months Ended
	September 28, 2019		September 29, 2018		September 28, 2019		September 29, 2018
Net revenue⁽¹⁾:
United States	$	4,341	$	2,244	$	11,596	$	4,391
United Kingdom		773		937		1,747		2,049
Germany		194		252		871		1,098
Australia		251		167		561		987
All other countries		1,646		439		2,772		948
Total net revenue	$	7,205	$	4,039	$	17,547	$	9,473

Schedule of Geographic Area

	September 28, 2019		December 29, 2018
Long-lived assets⁽²⁾:
United States	$	3,906	$	2,567
Netherlands		840		907
Total long-lived assets	$	4,746	$	3,474

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

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

Significant Customer Concentrations (Tables)

9 Months Ended

Sep. 28, 2019

Customer Concentration [Abstract]

Schedule of Net revenue:

Net revenue:

Fiscal Three Months Ended

Fiscal Nine Months Ended

September 28, 2019

September 29, 2018

September 28, 2019

September 29, 2018

Company A

Company B

Company C

Company D

*	Less than 10% of total

Schedule of Accounts receivable:

Accounts receivable:

	September 28, 2019	December 29, 2018
Company A	*	15%
Company B	*	13%

*	Less than 10% of total

Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended			6 Months Ended	9 Months Ended		12 Months Ended
	May 06, 2019	Sep. 28, 2019	Sep. 29, 2018	Jun. 30, 2018	Jun. 30, 2018	Sep. 28, 2019	Sep. 29, 2018	Dec. 29, 2018
Convertible preferred stock conversion ratio						3.5-for-one
Equity Method Investment, Ownership Percentage		100.00%				100.00%
Net loss						$ (24,370)	$ (16,121)	$ (23,800)
Accumulated deficit		$ (360,306)				(360,306)		$ (335,936)
Cash equivalents and marketable securities		$ 88,300				$ 88,300
Weighted average common shares outstanding, basic and diluted		21,131,618	1,368,260	1,338,880	1,336,283	11,882,626	1,346,942
Net loss per share attributable to common stockholders, basic and diluted		$ (0.39)	$ (3.73)	$ 4.57	$ 8.24	$ (2.05)	$ (11.97)
As Reported [Member]
Weighted average common shares outstanding, basic and diluted				4,686,080	4,676,991
Net loss per share attributable to common stockholders, basic and diluted				$ 1.30	$ 2.36
IPO [Member]
Stock Issued During Period, Shares, New Issues	6,543,500
Net proceeds from initial public offering	$ 91,400
Underwriting discounts and commissions and other offering costs	$ 6,000
Over-Allotment Option [Member]
Stock Issued During Period, Shares, New Issues	853,500

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
	May 06, 2019	Sep. 28, 2019	Sep. 29, 2018	Sep. 28, 2019	Sep. 29, 2018	Dec. 29, 2018
Deferred Offering Costs						$ 3,400
Clinical Trial Cost		$ 671	$ 716	$ 1,834	$ 1,303
Research development and clinical trials expenses		400	$ 200	900	$ 300
Performance obligations totaled		$ 300		$ 300		$ 1,500
IPO [Member]
Issuance costs	$ 6,000
Maximum [Member]
Concentration Risk, Percentage				10.00%
Accounts Receivable [Member]
Concentration Risk, Percentage				10.00%

Summary of Significant Accounting Policies - Recognized revenue net of payments (Detail) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 28, 2019

Sep. 29, 2018

Sep. 28, 2019

Sep. 29, 2018

Gross revenue from sales to customers

$ 7,876

$ 4,755

$ 19,381

$ 10,776

Clinical Trial Cost

671

716

1,834

1,303

^[1]

$ 7,205

$ 4,039

$ 17,547

$ 9,473

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

Summary of Significant Accounting Policies - Net revenue by OCS product (Detail) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 28, 2019

Sep. 29, 2018

Sep. 28, 2019

Sep. 29, 2018

^[1]

$ 7,205

$ 4,039

$ 17,547

$ 9,473

United States

^[1]

4,341

2,244

11,596

4,391

Outside the U.S.

2,864

1,795

5,951

5,082

OCS Lung net revenue

2,114

1,487

5,744

3,146

OCS Heart net revenue

3,739

1,639

8,305

4,860

OCS Liver net revenue

$ 1,352

$ 913

$ 3,498

$ 1,467

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

Components of Marketable Securities by Security Type (Detail) $ in Thousands	Sep. 28, 2019 USD ($)
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	$ 67,813
Marketable Securities, Gross Unrealized Gains	52
Marketable Securities, Fair Value	67,865
U.S. Treasury Securities [Member]
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	12,218
Marketable Securities, Gross Unrealized Gains	3
Marketable Securities, Fair Value	12,221
U.S. Government Agency Bonds [Member]
Schedule Of Available For Sale Securities [Line Items]
Marketable Securities, Amortized Cost	55,595
Marketable Securities, Gross Unrealized Gains	49
Marketable Securities, Fair Value	$ 55,644

Fair Value of Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands	Sep. 28, 2019	Dec. 29, 2018
Cash equivalents:
Money market funds	$ 12,126	$ 13,586
Marketable securities:
Marketable securities	67,865
Cash equivalents and marketable securities	79,991
Cash Equivalents, at Carrying Value		13,586
Liabilities:
Preferred stock warrant liability		898
Level 1 [Member]
Cash equivalents:
Money market funds	12,126	13,586
Marketable securities:
Cash equivalents and marketable securities	12,126
Cash Equivalents, at Carrying Value		13,586
Level 2 [Member]
Marketable securities:
Cash equivalents and marketable securities	67,865
Level 3 [Member]
Liabilities:
Preferred stock warrant liability		$ 898
U.S. Treasury Securities [Member]
Marketable securities:
Marketable securities	12,221
U.S. Treasury Securities [Member] \| Level 2 [Member]
Marketable securities:
Marketable securities	12,221
U.S. Government Agency Bonds [Member]
Marketable securities:
Marketable securities	55,644
U.S. Government Agency Bonds [Member] \| Level 2 [Member]
Marketable securities:
Marketable securities	$ 55,644

Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands	Sep. 28, 2019	Dec. 29, 2018	Dec. 31, 2016
Accrued Expenses And Other Current Liabilities [Abstract]
Accrued research, development and clinical trials expenses	$ 3,072	$ 1,853
Accrued payroll and related expenses	3,515	1,729
Accrued financing fees (Note 10)	340	1,466	$ 1,500
Accrued professional fees	837	549
Accrued premium for manufacturing contract		1,089
Accrued other	1,584	492
Accrued Expenses And Other Liabilities Current	$ 9,348	$ 7,178

Inventory (Detail) - USD ($) $ in Thousands	Sep. 28, 2019	Dec. 29, 2018
Inventory Disclosure [Abstract]
Raw materials	$ 4,665	$ 3,817
Work-in-process	924	882
Finished goods	4,947	4,578
Inventory, net	$ 10,536	$ 9,277

Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 28, 2019	Dec. 29, 2018	Jun. 30, 2018
Long-term debt	$ 35,000	$ 35,000
Description of variable rate basis	London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0% and a maximum of 4.0%
Basis spread on variable rate	8.50%
Interest rate effective percentage	11.30%
Prepayment premium percentage	9.00%
Prepayment percentage	3.00%
Description of covenants	The covenants include maintaining a minimum liquidity amount of $3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from the Company’s independent registered public accounting firm; and restrictions on the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions.
Minimum liquidity covenant amount	$ 3,000
Average effective interest rate	12.90%
In Event Of Default [Member]
Increasing applicable margin	4.00%
Minimum [Member]
LIBOR Rate	1.00%
LIBOR plus the applicable margin, percentage	11.50%
Maximum [Member]
LIBOR Rate	4.00%
Interest rate effective percentage	11.50%
LIBOR plus the applicable margin, percentage	12.50%
Orbi Med [Member]
Long-term debt			$ 35,000

Long-term Debt (Detail) - USD ($) $ in Thousands	Sep. 28, 2019	Dec. 29, 2018
Debt Disclosure [Abstract]
Principal amount of long-term debt	$ 35,000	$ 35,000
Debt discount, net of accretion	(1,213)	(1,424)
Accrued end-of-term payment	236	94
Long-term debt, net of discount	$ 34,023	$ 33,670

Convertible Preferred Stock and Warrants to Purchase Preferred Stock (Detail) - USD ($) $ in Thousands	May 06, 2019	Dec. 29, 2018
Preferred Stock Authorized		50,776,054
Preferred Stock Issued and Outstanding		50,404,140
Carrying Value		$ 186,519
Liquidation Preference		$ 223,681
Common Stock Issuable Upon Conversion	13,119,424	13,119,424
Series A-1 Preferred Stock
Preferred Stock Authorized		13,332
Preferred Stock Issued and Outstanding		13,332
Carrying Value		$ 3,333
Liquidation Preference		$ 33
Common Stock Issuable Upon Conversion		984
Series B Preferred Stock
Preferred Stock Authorized		3,771,020
Preferred Stock Issued and Outstanding		3,624,650
Carrying Value		$ 10,691
Liquidation Preference		$ 12,382
Common Stock Issuable Upon Conversion		286,102
Series B-1 Preferred Stock
Preferred Stock Authorized		2,560,245
Preferred Stock Issued and Outstanding		2,560,245
Carrying Value		$ 8,746
Liquidation Preference		$ 8,746
Common Stock Issuable Upon Conversion		202,086
Series C Preferred Stock
Preferred Stock Authorized		6,198,057
Preferred Stock Issued and Outstanding		6,198,057
Carrying Value		$ 14,970
Liquidation Preference		$ 15,495
Common Stock Issuable Upon Conversion		1,770,873
Series D Preferred Stock
Preferred Stock Authorized		14,740,000
Preferred Stock Issued and Outstanding		14,565,000
Carrying Value		$ 34,868
Liquidation Preference		$ 72,825
Common Stock Issuable Upon Conversion		4,161,428
Series E Preferred Stock
Preferred Stock Authorized		6,562,232
Preferred Stock Issued and Outstanding		6,562,232
Carrying Value		$ 29,865
Liquidation Preference		$ 29,966
Common Stock Issuable Upon Conversion		1,874,923
Series F Preferred Stock
Preferred Stock Authorized		16,931,168
Preferred Stock Issued and Outstanding		16,880,624
Carrying Value		$ 84,046
Liquidation Preference		$ 84,234
Common Stock Issuable Upon Conversion		4,823,028

Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions		9 Months Ended
	Apr. 15, 2019	Sep. 28, 2019
2014 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period		10 years
2019 Stock Plan [Member]
Shares available for future issuance	3,428,571	2,987,866
2019 Stock Incentive Plan [Member] \| Common Stock \| Employees and Director [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross		457,357
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price		$ 8.54
2019 Employee Stock Purchase Plan [Member]
Unrecognized compensation cost related to unvested share-based awards		$ 4.0
Weighted average period for unrecognized compensation cost		2 years 11 months 15 days
2019 Employee Stock Purchase Plan [Member] \| Board of Directors Chairman [Member]
Shares available for future issuance	371,142	371,142
Number of shares issued		0
Minimum [Member] \| 2014 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period		3 years
Maximum [Member] \| 2014 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period		4 years
Maximum [Member] \| 2014 Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period	1,595,189

Commitments and Contingencies (Detail) $ in Thousands	Sep. 28, 2019 USD ($)
Commitments And Contingencies Disclosure [Abstract]
December 28, 2019 (remaining 3 months)	$ 388
December 26, 2020	1,570
December 25, 2021	1,589
Future minimum payments due	$ 3,547

Net Loss per Share - Basic and diluted net loss per share attributable to common stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						6 Months Ended	9 Months Ended
	Sep. 28, 2019	Jun. 29, 2019	Mar. 30, 2019	Sep. 29, 2018	Jun. 30, 2018	Mar. 31, 2018	Jun. 30, 2018	Sep. 28, 2019	Sep. 29, 2018
Numerator:
Net loss attributable to common stockholders	$ (8,280)	$ (9,195)	$ (6,895)	$ (5,105)	$ (6,115)	$ (4,901)		$ (24,370)	$ (16,121)
Denominator:
Weighted average common shares outstanding, basic and diluted	21,131,618			1,368,260	1,338,880		1,336,283	11,882,626	1,346,942
Net loss per share attributable to common stockholders, basic and diluted	$ (0.39)			$ (3.73)	$ 4.57		$ 8.24	$ (2.05)	$ (11.97)

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

+ References + Details

Segment Reporting and Geographic Data - Financial data by geographical area (Detail) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 28, 2019

Sep. 29, 2018

Sep. 28, 2019

Sep. 29, 2018

^[1]

$ 7,205

$ 4,039

$ 17,547

$ 9,473

UNITED STATES

^[1]

4,341

2,244

11,596

4,391

UNITED KINGDOM

^[1]

773

937

1,747

2,049

GERMANY

^[1]

194

252

871

1,098

AUSTRALIA

^[1]

251

167

561

987

All other countries