Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | TransMedics Group, Inc. | |
Entity Central Index Key | 0001756262 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding | 32,647,698 | |
Entity File Number | 001-38891 | |
Entity Incorporation, State or Country Code | MA | |
Entity Tax Identification Number | 83-2181531 | |
Entity Address, Address Line One | 200 Minuteman Road | |
Entity Address, City or Town | Andover | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01810 | |
City Area Code | 978 | |
Local Phone Number | 552-0900 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, No Par Value | |
Trading Symbol | TMDX | |
Security Exchange Name | NASDAQ |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 427,110 | $ 201,182 |
Accounts receivable | 60,654 | 27,611 |
Inventory | 39,365 | 20,605 |
Prepaid expenses and other current assets | 9,595 | 2,896 |
Total current assets | 536,724 | 252,294 |
Property, plant and equipment, net | 131,004 | 19,223 |
Operating lease right-of-use assets | 6,861 | 5,130 |
Restricted cash | 500 | 500 |
Goodwill | 11,673 | |
Acquired intangible assets, net | 2,405 | |
Other non-current assets | 60 | |
Total assets | 689,227 | 277,147 |
Current liabilities: | ||
Accounts payable | 12,836 | 3,341 |
Accrued expenses and other current liabilities | 31,651 | 18,635 |
Deferred revenue | 2,629 | 241 |
Operating lease liabilities | 1,985 | 1,444 |
Total current liabilities | 49,101 | 23,661 |
Convertible senior notes, net | 446,448 | |
Long-term debt, net | 58,986 | 58,696 |
Operating lease liabilities, net of current portion | 8,232 | 7,415 |
Total liabilities | 562,767 | 89,772 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock, no par value; 25,000,000 shares authorized; no shares issued or outstanding | ||
Common stock, no par value; 150,000,000 shares authorized; 32,642,130 shares and 32,141,368 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 634,458 | 666,277 |
Accumulated other comprehensive loss | (262) | (225) |
Accumulated deficit | (507,736) | (478,677) |
Total stockholders' equity | 126,460 | 187,375 |
Total liabilities and stockholders' equity | $ 689,227 | $ 277,147 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, No Par Value | ||
Preferred Stock, Shares Authorized | 25,000,000 | 25,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, No Par Value | ||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 |
Common Stock, Shares, Issued | 32,642,130 | 32,141,368 |
Common Stock, Shares, Outstanding | 32,642,130 | 32,141,368 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 66,430 | $ 25,683 | $ 160,449 | $ 62,084 |
Cost of revenue: | ||||
Total cost of revenue | 25,768 | 7,568 | 54,280 | 17,515 |
Gross profit | 40,662 | 18,115 | 106,169 | 44,569 |
Operating expenses: | ||||
Research, development and clinical trials | 11,132 | 6,808 | 25,294 | 21,056 |
Acquired in-process research and development expenses | 27,212 | 27,212 | ||
Selling, general and administrative | 30,653 | 16,851 | 84,993 | 48,171 |
Total operating expenses | 68,997 | 23,659 | 137,499 | 69,227 |
Loss from operations | (28,335) | (5,544) | (31,330) | (24,658) |
Other income (expense): | ||||
Interest expense | (3,590) | (787) | (7,186) | (2,719) |
Other income (expense), net | 4,996 | (1,076) | 7,982 | (2,087) |
Total other income (expense), net | 1,406 | (1,863) | 796 | (4,806) |
Loss before income taxes | (26,929) | (7,407) | (30,534) | (29,464) |
(Provision) benefit for income taxes | 1,507 | (19) | 1,475 | (47) |
Net loss | $ (25,422) | $ (7,426) | $ (29,059) | $ (29,511) |
Net loss per share attributable to common stockholders, basic | $ (0.78) | $ (0.25) | $ (0.89) | $ (1.03) |
Net loss per share attributable to common stockholders, diluted | $ (0.78) | $ (0.25) | $ (0.89) | $ (1.03) |
Weighted average common shares outstanding, basic | 32,614,059 | 30,229,936 | 32,474,522 | 28,729,649 |
Weighted average common shares outstanding, diluted | 32,614,059 | 30,229,936 | 32,474,522 | 28,729,649 |
Net product revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 47,740 | $ 21,299 | $ 124,195 | $ 54,160 |
Cost of revenue: | ||||
Total cost of revenue | 11,086 | 4,231 | 26,950 | 11,689 |
Service Revenue [Member] | ||||
Revenue: | ||||
Total revenue | 18,690 | 4,384 | 36,254 | 7,924 |
Cost of revenue: | ||||
Total cost of revenue | $ 14,682 | $ 3,337 | $ 27,330 | $ 5,826 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (25,422) | $ (7,426) | $ (29,059) | $ (29,511) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustment | (42) | (41) | (37) | (95) |
Unrealized gains on marketable securities, net of tax of $0 | 100 | 36 | ||
Total other comprehensive income (loss) | (42) | 59 | (37) | (59) |
Comprehensive loss | $ (25,464) | $ (7,367) | $ (29,096) | $ (29,570) |
CONSOLIDATED STATEMENTS OF CO_2
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Other Comprehensive Income (Loss), Securities, Available-for-Sale, Unrealized Holding Gain (Loss) Arising During Period, Tax | $ 0 | $ 0 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 67,854 | $ 510,488 | $ (188) | $ (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 | |||
Issuance of common stock upon the exercise of common stock options | 202 | $ 202 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 164,503 | |||
Issuance of common stock in connection with employee stock purchase plan | 203 | $ 203 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 12,465 | |||
Stock-based compensation expense | 2,310 | $ 2,310 | ||
Foreign currency translation adjustment | (24) | (24) | ||
Unrealized losses on marketable securities | (73) | (73) | ||
Net loss | (10,562) | (10,562) | ||
Balance at Mar. 31, 2022 | 59,910 | $ 513,203 | (285) | (453,008) |
Balance, Shares at Mar. 31, 2022 | 27,968,583 | |||
Balance at Dec. 31, 2021 | 67,854 | $ 510,488 | (188) | (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 | |||
Foreign currency translation adjustment | (95) | |||
Unrealized losses on marketable securities | 36 | |||
Net loss | (29,511) | |||
Balance at Sep. 30, 2022 | 187,857 | $ 660,061 | (247) | (471,957) |
Balance, Shares at Sep. 30, 2022 | 31,933,984 | |||
Balance at Dec. 31, 2021 | 67,854 | $ 510,488 | (188) | (442,446) |
Balance, Shares at Dec. 31, 2021 | 27,791,615 | |||
Net loss | (36,200) | |||
Balance at Dec. 31, 2022 | 187,375 | $ 666,277 | (225) | (478,677) |
Balance, Shares at Dec. 31, 2022 | 32,141,368 | |||
Balance at Mar. 31, 2022 | 59,910 | $ 513,203 | (285) | (453,008) |
Balance, Shares at Mar. 31, 2022 | 27,968,583 | |||
Issuance of common stock upon the exercise of common stock options | 237 | $ 237 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 31,592 | |||
Stock-based compensation expense | 2,316 | $ 2,316 | ||
Issuance of restricted common stock | 23,120 | |||
Foreign currency translation adjustment | (30) | (30) | ||
Unrealized losses on marketable securities | 9 | 9 | ||
Net loss | (11,523) | (11,523) | ||
Balance at Jun. 30, 2022 | 50,919 | $ 515,756 | (306) | (464,531) |
Balance, Shares at Jun. 30, 2022 | 28,023,295 | |||
Issuance of common stock in public offering, net of discounts and issuance costs, Shares | 3,737,500 | |||
Issuance of common stock in public offering, net of discounts and issuance costs | 139,854 | $ 139,854 | ||
Issuance of common stock upon the exercise of common stock options | 1,441 | $ 1,441 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 154,316 | |||
Issuance of common stock in connection with employee stock purchase plan | 306 | $ 306 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 17,678 | |||
Stock-based compensation expense | 2,704 | $ 2,704 | ||
Restricted common stock forfeitures | (1,778) | |||
Issuance of restricted common stock | 2,973 | |||
Foreign currency translation adjustment | (41) | (41) | ||
Unrealized losses on marketable securities | 100 | 100 | ||
Net loss | (7,426) | (7,426) | ||
Balance at Sep. 30, 2022 | 187,857 | $ 660,061 | (247) | (471,957) |
Balance, Shares at Sep. 30, 2022 | 31,933,984 | |||
Balance at Dec. 31, 2022 | 187,375 | $ 666,277 | (225) | (478,677) |
Balance, Shares at Dec. 31, 2022 | 32,141,368 | |||
Issuance of common stock upon the exercise of common stock options | 3,574 | $ 3,574 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 378,500 | |||
Issuance of common stock in connection with employee stock purchase plan | 384 | $ 384 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 14,135 | |||
Stock-based compensation expense | 3,921 | $ 3,921 | ||
Foreign currency translation adjustment | 7 | 7 | ||
Net loss | (2,636) | (2,636) | ||
Balance at Mar. 31, 2023 | 192,625 | $ 674,156 | (218) | (481,313) |
Balance, Shares at Mar. 31, 2023 | 32,534,003 | |||
Balance at Dec. 31, 2022 | 187,375 | $ 666,277 | (225) | (478,677) |
Balance, Shares at Dec. 31, 2022 | 32,141,368 | |||
Foreign currency translation adjustment | (37) | |||
Net loss | (29,059) | |||
Balance at Sep. 30, 2023 | 126,460 | $ 634,458 | (262) | (507,736) |
Balance, Shares at Sep. 30, 2023 | 32,642,130 | |||
Balance at Mar. 31, 2023 | 192,625 | $ 674,156 | (218) | (481,313) |
Balance, Shares at Mar. 31, 2023 | 32,534,003 | |||
Issuance of common stock upon the exercise of common stock options | 705 | $ 705 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 39,158 | |||
Stock-based compensation expense | 4,958 | $ 4,958 | ||
Purchases of capped calls related to convertible senior notes | (52,072) | $ (52,072) | ||
Issuance of restricted common stock | 9,772 | |||
Foreign currency translation adjustment | (2) | (2) | ||
Net loss | (1,001) | (1,001) | ||
Balance at Jun. 30, 2023 | 145,213 | $ 627,747 | (220) | (482,314) |
Balance, Shares at Jun. 30, 2023 | 32,582,933 | |||
Issuance of common stock upon the exercise of common stock options | 952 | $ 952 | ||
Issuance of common stock upon the exercise of common stock options, Shares | 47,438 | |||
Issuance of common stock in connection with employee stock purchase plan | 571 | $ 571 | ||
Issuance of common stock in connection with employee stock purchase plan, Shares | 11,759 | |||
Stock-based compensation expense | 5,188 | $ 5,188 | ||
Foreign currency translation adjustment | (42) | (42) | ||
Net loss | (25,422) | (25,422) | ||
Balance at Sep. 30, 2023 | $ 126,460 | $ 634,458 | $ (262) | $ (507,736) |
Balance, Shares at Sep. 30, 2023 | 32,642,130 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 3 Months Ended |
Sep. 30, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Discounts and issuance costs | $ 676 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Cash flows from operating activities: | ||
Net loss | $ (29,059) | $ (29,511) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 4,572 | 2,193 |
Stock-based compensation expense | 14,067 | 7,330 |
Acquired in-process research and development expenses | 27,212 | |
Deferred taxes | (1,540) | |
Loss on extinguishment of debt | 575 | |
Loss on sale of marketable securities | 107 | |
Non-cash interest expense and end of term accretion expense | 1,358 | 309 |
Non-cash lease expense | 728 | 532 |
Net amortization of premiums on marketable securities | 381 | |
Unrealized foreign currency transaction losses | 118 | 1,733 |
Changes in operating assets and liabilities, net of acquired assets and liabilities: | ||
Accounts receivable | (30,997) | (16,287) |
Inventory | (21,029) | (6,094) |
Prepaid expenses and other current assets | (2,170) | (98) |
Other non-current assets | (54) | |
Accounts payable | 6,541 | (3,534) |
Accrued expenses and other current liabilities | 9,257 | (8) |
Deferred revenue | 765 | |
Operating lease liabilities | (1,101) | 590 |
Net cash used in operating activities | (21,332) | (41,782) |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment | (110,029) | (9,143) |
Purchase of business, net of cash acquired | (14,894) | |
Purchase of in-process research and development assets | (27,212) | |
Purchases of marketable securities | (10,496) | |
Proceeds from sales and maturities of marketable securities | 76,916 | |
Net cash provided by (used in) investing activities | (152,135) | 57,277 |
Cash flows from financing activities: | ||
Proceeds from issuance of convertible senior notes, net of issuance costs paid of $14,620 | 445,380 | |
Purchases of capped calls related to convertible senior notes | (52,072) | |
Proceeds from issuance of long-term debt, net of issuance costs and issuance costs paid | 58,509 | |
Repayments of long-term debt | (36,050) | |
Proceeds from issuance of common stock in public offering, net of underwriting discounts and commissions | 140,014 | |
Proceeds from issuance of common stock upon exercise of stock options | 5,231 | 1,880 |
Proceeds from issuance of common stock in connection with employee stock purchase plan | 955 | 509 |
Net cash provided by financing activities | 399,494 | 164,862 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (99) | (1,475) |
Net increase in cash, cash equivalents and restricted cash | 225,928 | 178,882 |
Cash, cash equivalents and restricted cash, beginning of period | 201,682 | 26,080 |
Cash, cash equivalents and restricted cash, end of period | 427,610 | 204,962 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Transfers of inventory to property, plant and equipment | 2,224 | 2,055 |
Purchases of property, plant and equipment included in accounts payable and accrued expenses | 1,724 | 926 |
Operating lease liabilities arising from obtaining right-of-use assets | 2,171 | |
Offering costs included in accounts payable and accrued expenses | 160 | |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 427,110 | 204,462 |
Restricted cash | 500 | 500 |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 427,610 | $ 204,962 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASHFLOWS (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Statement of Cash Flows [Abstract] | |
Convertible senior notes, issuance costs paid | $ 14,620 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | |||||||||
Net Income (Loss) | $ (25,422) | $ (1,001) | $ (2,636) | $ (7,426) | $ (11,523) | $ (10,562) | $ (29,059) | $ (29,511) | $ (36,200) |
Insider Trading Arrangements
Insider Trading Arrangements | 9 Months Ended | |
Sep. 30, 2023 shares | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | During our fiscal quarter ended September 30, 2023, certain of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) entered into contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the conditions specified in Rule 10b5-1(c) under the Exchange Act for an affirmative defense against liability for trading in securities on the basis of material nonpublic information. We refer to these contracts, instructions, and written plans as “Rule 10b5-1 trading plans” and each one as a “Rule 10b5-1 trading plan.” We describe the material terms of these Rule 10b5-1 trading plans in the table below. Rule 10b5-1 Trading Plans Maximum Number of Securities to Scheduled be Purchased or Action Commencement Termination Sold Pursuant to Covers and Date of Trading of Trading Security the Rule 10b5-1 Purchase Director/Officer of Action Period Period (1) Covered Trading Plan (2) Or Sale Waleed Hassanein , M.D., Chief Adoption 6-Sep-23 16-Jan-24 31-Dec-24 Common Stock 171,000 Sale Tamer Khayal , Chief Commercial Adoption 6-Sep-23 16-Jan-24 15-Jan-25 Common Stock 139,727 (3) Sale Edward Basile , Director Adoption 6-Sep-23 6-Feb-24 31-Dec-24 Common Stock 27,814 Sale Stephen Gordon , Chief Financial Adoption 14-Sep-23 1-Jan-24 31-Dec-24 Common Stock 77,060 Sale (1) The plans are subject to earlier termination under certain circumstances specified in the plans, including upon the sale or purchase (as applicable) of all shares subject to the plan and upon either party to a plan giving notice of termination within the time prescribed under the plan. (2) Subject to adjustments for stock splits, stock combinations, stock dividends and other similar changes to our common stock. (3) Pursuant to the plan, Mr. Khayal may also sell up to 24,776 additional shares of common stock if such shares of common stock remain unsold pursuant to existing 10b5-1 plans entered into by Mr. Khayal and certain of his affiliates upon the termination of such plans and up to 4,359 shares of common stock underlying RSUs that may vest on February 20, 2024, subject to Mr. Khayal’s continued service to the Company as of such date . As of the date of this report, there were 24,776 shares that remained unsold pursuant to such existing plans. | |
Rule10b5-1 Trading Plan [Member] | Waleed Hassanein [Member] | ||
Trading Arrangements, by Individual | ||
Name | Waleed Hassanein | |
Title | M.D., Chief Executive Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 6-Sep-23 | |
Termination Date | 31-Dec-24 | [1] |
Aggregate Available | 171,000 | [2] |
Rule10b5-1 Trading Plan [Member] | Tamer Khayal [Member] | ||
Trading Arrangements, by Individual | ||
Name | Tamer Khayal | |
Title | Chief Commercial Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 6-Sep-23 | |
Termination Date | 15-Jan-25 | [1] |
Aggregate Available | 139,727 | [2],[3] |
Rule10b5-1 Trading Plan [Member] | Edward Basile [Member] | ||
Trading Arrangements, by Individual | ||
Name | Edward Basile | |
Title | Director | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 6-Sep-23 | |
Termination Date | 31-Dec-24 | [1] |
Aggregate Available | 27,814 | [2] |
Rule10b5-1 Trading Plan [Member] | Stephen Gordon [Member] | ||
Trading Arrangements, by Individual | ||
Name | Stephen Gordon | |
Title | Chief Financial Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | 14-Sep-23 | |
Termination Date | 31-Dec-24 | [1] |
Aggregate Available | 77,060 | [2] |
[1] The plans are subject to earlier termination under certain circumstances specified in the plans, including upon the sale or purchase (as applicable) of all shares subject to the plan and upon either party to a plan giving notice of termination within the time prescribed under the plan. Subject to adjustments for stock splits, stock combinations, stock dividends and other similar changes to our common stock. Pursuant to the plan, Mr. Khayal may also sell up to 24,776 additional shares of common stock if such shares of common stock remain unsold pursuant to existing 10b5-1 plans entered into by Mr. Khayal and certain of his affiliates upon the termination of such plans and up to 4,359 shares of common stock underlying RSUs that may vest on February 20, 2024, subject to Mr. Khayal’s continued service to the Company as of such date . As of the date of this report, there were 24,776 shares that remained unsold pursuant to such existing plans. |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation TransMedics Group, Inc. (“TransMedics Group” and, together with its consolidated subsidiaries, the “Company”) was incorporated in the Commonwealth of Massachusetts in October 2018. TransMedics, Inc. (“TransMedics”), an operating company and wholly owned subsidiary of TransMedics Group, was incorporated in the State of Delaware in August 1998. The Company is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. The Company developed the Organ Care System (“OCS”) to replace a decades-old standard of care. The OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. The Company’s OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. The Company also developed its National OCS Program (“NOP”), an innovative turnkey solution to provide outsourced organ retrieval, OCS organ management and organ transportation, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. On August 16, 2023, the Company acquired Summit Aviation, Inc. and Northside Property Group, LLC (together “Summit”). Summit is a charter flight operator based in Bozeman, Montana. The acquisition enabled TransMedics to add aircraft transportation services to its NOP and become a comprehensive national provider of donor organ retrieval and delivery in the United States. The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including net losses of $ 29.1 million for the nine months ended September 30, 2023 and $ 36.2 million for the year ended December 31, 2022. As of September 30, 2023, the Company had an accumulated deficit of $ 507.7 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company believes that its existing cash of $ 427.1 million as of September 30, 2023 will be sufficient to fund its operations, capital expenditures, and debt service payments for at least the next 12 months following the filing of this Quarterly Report on Form 10-Q. The Company may need to seek additional funding through equity financings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations. The Company is subject to risks and uncertainties common to companies in the medical device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. Products currently under development will require additional research and development efforts, including additional clinical testing and regulatory approval, prior to commercialization. These efforts require additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, the Company may not obtain necessary government regulatory approval on its expected timeline or at all, and approved products may not prove commercially viable. The Company operates in an environment of rapid change in technology and competition. Continued impacts to the Company’s business as a result of the COVID-19 pandemic may include decreased overall frequency of transplant procedures; disruptions to the Company’s manufacturing operations and supply chain; labor shortages; decreased productivity and unavailability of materials or components; limitations on its employees’ and customers’ ability to travel, and delays in product installations, trainings or shipments to and from other affected countries and within the United States. While the Company maintains an inventory of finished products and raw materials used in its OCS products, a further prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products. The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Interim Financial Information The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2023 and results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022 have been made. The Company’s results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited consolidated financial statements include, but are not limited to, revenue recognition, the valuation of inventory, the valuation of assets acquired and liabilities assumed in business combinations, including acquired intangible assets and the resulting goodwill, and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. Risk of Concentrations of Credit, Significant Customers and Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and accounts receivable. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of September 30, 2023 and December 31, 2022, the Company had no allowance for credit losses. Significant customers are those that accounted for 10 % or more of the Company’s revenue or accounts receivable. For the three and nine months ended September 30, 2023 , no customer accounted for more than 10 % of revenue. For the three months ended September 30, 2022 , one customer accounted for 13 % of revenue. For the nine months ended September 30, 2022 , one customer accounted for 15 % of revenue. As of September 30, 2023 one customer accounted for 13 % of accounts receivable. As of December 31, 2022 , no customer accounted for more than 10 % of accounts receivable. Certain of the components and subassemblies included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers, as are sterilization services. Although the Company seeks to reduce dependence on those limited sources of suppliers, manufacturers and service providers, the partial or complete loss of certain of these sources could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships. Business Combinations In determining whether an acquisition should be accounted for as a business combination or asset acquisition, the Company first determines whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this is the case, the single identifiable asset or the group of similar assets is not deemed to be a business and the acquisition is accounted for as an asset acquisition. If this is not the case, the Company then further evaluates whether the acquisition includes, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. If so, the Company concludes that the acquisition is a business and accounts for it as a business combination. The Company accounts for business combinations using the acquisition method of accounting. In accordance with this method, assets acquired and liabilities assumed are recorded at their respective fair values at the acquisition date. The fair value of the consideration paid is assigned to the assets acquired and liabilities assumed based on their respective fair values. Goodwill represents the excess of the purchase price over the estimated fair values of the assets acquired and liabilities assumed. Determining the fair value of assets acquired and liabilities assumed is judgmental in nature and can involve the use of significant estimates and assumptions. Fair value and useful life determinations are based on, among other things, valuations that use information and assumptions provided by management, which consider management’s best estimates of inputs and assumptions that a market participant would use. Actual results may vary from these estimates and may result in adjustments to goodwill and acquisition date fair values of assets and liabilities during a measurement period or upon a final determination of asset and liability fair values, whichever comes first. Adjustments to fair values of assets and liabilities made after the end of the measurement period are recorded within operating results. Transaction costs related to business combinations are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations. Asset Acquisitions The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the asset or group of assets, which includes transaction costs. Goodwill is not recognized in asset acquisitions. In an asset acquisition, the cost allocated to acquire in-process research and development (“IPR&D”) with no alternative future use is charged to expense at the acquisition date. Goodwill and Acquired Intangible Assets The Company records goodwill when consideration paid in a business combination exceeds the value of the net assets acquired. The Company’s estimates of fair value are based upon assumptions believed to be reasonable at that time, but that are inherently uncertain and unpredictable. Goodwill is not amortized, but rather is tested for impairment annually in the fourth quarter, or more frequently if facts and circumstances warrant a review, such as significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. The Company has determined that there is a single reporting unit for the purpose of conducting this goodwill impairment assessment. The Company has the option of performing either a qualitative or quantitative assessment to determine whether further impairment testing is necessary. If it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount, a quantitative impairment test will be required. The quantitative goodwill impairment test requires management to estimate and compare the fair value of the reporting unit with its carrying value. If the fair value of the reporting unit exceeds the carrying value of the net assets, goodwill is not impaired. If the fair value of the reporting unit is less than the carrying value, the difference is recorded as an impairment loss up to the amount of goodwill. Intangible assets are recorded at their estimated fair values at the date of acquisition and are reported net of accumulated amortization. The Company amortizes acquired intangible assets with finite lives over their estimated useful lives based on the pattern of consumption of the economic benefits or, if that pattern cannot be readily determined, on a straight-line basis. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate. The Company's 1.50 % Convertible Senior Notes due 2028 (the "Notes") are carried at the face value less unamortized debt discount and issuance costs on the consolidated balance sheets, and the fair value of the convertible senior notes is presented at each reporting period for disclosure purposes only. Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company has developed and is commercializing a proprietary system to preserve and deliver human organs for transplant in a near-physiologic condition to address the limitations of cold storage organ preservation. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance. Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding common stock equivalents. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three and nine months ended September 30, 2023 and 2022. The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 3,191,755 3,309,558 Employee stock purchase plan 9,370 8,886 Restricted stock units 241,167 — Restricted stock awards 9,772 24,315 Convertible senior notes 4,893,848 — 8,410,352 3,407,199 |
Marketable Securities and Fair
Marketable Securities and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities and Fair Value Measurements [Abstract] | |
Marketable Securities and Fair Value Measurements | 3. Marketable Securities and Fair Value Measurements The Company did no t have marketable securities as of September 30, 2023 or December 31, 2022. The Company also did no t have assets or liabilities measured at fair value on a recurring basis as of September 30, 2023 or December 31, 2022. Convertible Senior Notes As of September 30, 2023, the carrying value of the Notes was $ 446.4 million (see Note 9) and the estimated fair value of the Notes was $ 426.2 million. The fair value was determined based on the quoted price of the last trade of the Notes prior to the end of the reporting period in an inactive market, which is considered as Level 2 in the fair value hierarchy. |
Acquisition of Summit
Acquisition of Summit | 9 Months Ended |
Sep. 30, 2023 | |
Business Combinations [Abstract] | |
Acquisition of Summit | 4. Acquisition of Summit On August 16, 2023 , the Company acquired Summit pursuant to the terms of an equity purchase agreement. Summit is a charter flight operator based in Bozeman, Montana. The acquisition enabled TransMedics to add aircraft transportation services to its NOP and become a comprehensive national provider of donor organ retrieval and delivery in the United States. The acquisition was accounted for as a purchase of a business under ASC Topic 805, Business Combinations. Under the acquisition method of accounting, the assets and liabilities were recorded as of the acquisition date, at their respective fair values. The preliminary purchase consideration of $ 14.9 million reflected an upfront cash payment of $ 18.0 million, net of cash acquired and working capital adjustments. The Company’s consolidated financial statements reflect the preliminary allocation of the purchase price to the assets and liabilities assumed based on fair value as of the date of the acquisition. The Company's estimate of preliminary purchase consideration is subject to change upon finalizing working capital adjustments. The Company’s preliminary estimate of the fair value of specifically identifiable assets acquired and liabilities assumed as of the date of acquisition is subject to change upon finalizing its valuation analysis. The final determinations, which are expected to be completed by August 2024, may result in changes in the fair value of certain assets and liabilities as compared to these preliminary estimates. The following tables summarize the preliminary allocation of the purchase price (in thousands): Assets Acquired and Liabilities Assumed: Accounts receivable $ 2,089 Other current assets 1,040 Property, plant and equipment 5,922 Right-of-use asset 288 Intangible assets 2,430 Goodwill 11,673 Total assets acquired 23,442 Accounts payable and other current liabilities ( 6,720 ) Deferred tax liabilities ( 1,540 ) Operating lease liabilities ( 288 ) Total allocation of purchase price consideration, $ 14,894 Property, plant and equipment consist primarily of flight school aircraft and construction-in-progress related to a commercial aircraft hangar that Summit is in the process of constructing. Flight school aircraft were valued using market comparisons adjusted for aircraft-specific condition. The fair value of construction-in-progress approximated its cost. Intangible assets consisted primarily of a customer relationship asset of $ 2.3 million related to flight school revenue and was valued using the multi-period excess earnings method, a form of the income approach. Significant assumptions and estimates utilized in this model include the revenue growth rate, contract renewal probability and the discount rate, and is being amortized to selling, general and administrative over its estimated useful life of 12 years as of the acquisition date on a straight-line basis. Goodwill was recognized for the excess purchase price over the fair value of the net assets acquired. Goodwill is primarily attributable to the workforce of the acquired business (which is not eligible for separate recognition as an identifiable intangible asset) and anticipated synergies between Summit’s existing business processes and the NOP. Goodwill from the acquisition is included within the Company’s one reporting unit and is included in the Company’s enterprise-level annual review for impairment. Goodwill resulting from the acquisition is no t deductible for tax purposes. Deferred tax liabilities relate to the differences between the fair value recognized in purchase accounting and the tax basis of property, plant and equipment and intangible assets. The net deferred tax liability is a source of income to support the recognition of a portion of our existing deferred tax assets. Therefore, the Company recorded a tax benefit of $ 1.5 million for the release of a portion of its valuation allowance related to the net deferred tax liabilities recorded in purchase accounting. The Company incurred total transaction costs of $ 2.0 million for third-party professional services utilized for the acquisition, which are included in general and administrative costs in the statements of operations. The operating results of the acquired entity have been included in the consolidated financial statements beginning on the acquisition date. Pro forma results of operations for the acquisition have not been presented as they are not material to the Company’s consolidated results of operations. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory Inventory consisted of the following (in thousands): September 30, 2023 December 31, 2022 Raw materials $ 18,856 $ 10,939 Work-in-process 3,051 1,876 Finished goods 17,458 7,790 $ 39,365 $ 20,605 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | 6. Property, Plant and Equipment, Net Property, plant and equipment, net consisted of the following (in thousands): September 30, 2023 December 31, 2022 Transplant aircraft $ 102,985 $ — Flight school aircraft 3,484 — OCS Consoles 13,074 10,878 Manufacturing equipment 5,315 3,721 Computer equipment and software 2,782 2,064 Laboratory equipment 765 671 Office, trade show and training equipment 3,030 2,121 Leasehold improvements 12,917 12,415 Construction-in-progress 4,308 482 148,660 32,352 Less: Accumulated depreciation and amortization ( 17,656 ) ( 13,129 ) $ 131,004 $ 19,223 Depreciation and amortization expense of aircraft is recognized using the straight-line method over the estimated useful life of each asset to its salvage value. The estimated useful lives of aircraft are 10 years for transplant aircraft and five years for flight school aircraft. Residual values estimated for transplant and flight school aircraft are approximately 50 % of the original purchase price. Expenditures for repairs and maintenance are charged to expense as incurred. Construction-in-progress as of September 30, 2023 primarily relates to construction of a commercial aircraft hangar at Bozeman Yellowstone International Airport in Bozeman, Montana. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | 7. Goodwill and Intangible Assets The carrying amount of goodwill was $ 11.7 million as of September 30, 2023 related to the Company’s acquisition of Summit. Goodwill is not amortized, but instead is reviewed for impairment at least annually or more frequently when events and circumstances occur indicating that the recorded goodwill may be impaired. To date, the Company has had no impairments to goodwill. Acquired intangible assets consisted of the following (in thousands): September 30, 2023 Weighted Average Useful Life Gross Amount Accumulated Amortization Carrying Value (in years) Customer relationship 12 $ 2,320 $ 24 $ 2,296 Other 12 110 1 109 $ 2,430 $ 25 $ 2,405 Amortization expense is recorded within selling, general and administrative expense. Future amortization expense of the intangible assets as of September 30, 2023, is expected to be as follows (in thousands): Year Ending December 31, 2023 (three months) $ 49 2024 203 2025 203 2026 203 2027 203 Thereafter 1,544 $ 2,405 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | 8. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2023 December 31, 2022 Accrued payroll and related expenses $ 15,934 $ 9,812 Accrued transportation costs 4,375 2,581 Accrued research, development and clinical trials expenses 1,261 1,876 Accrued professional fees 2,073 965 Accrued interest 2,683 — Accrued other 5,325 3,401 $ 31,651 $ 18,635 |
Long-term Debt and Financing Ar
Long-term Debt and Financing Arrangements | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt and Financing Arrangements | 9. Long-Term Debt and Financing Arrangements Convertible Senior Notes Convertible senior notes consisted of the following (in thousands): September 30, 2023 Principal amount of convertible senior notes $ 460,000 Less: Current portion of convertible senior notes — Convertible senior notes, net of current portion 460,000 Debt discount, net of accretion ( 13,552 ) Convertible senior notes, net of discount and current portion $ 446,448 On May 11, 2023, the Company issued $ 460.0 million aggregate principal amount of the Notes, in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act, pursuant to an indenture dated May 11, 2023, by and between the Company and U.S. Bank Trust Company, National Association (the “Indenture”). The initial conversion price of the Notes is approximately $ 94.00 per share of common stock, which represents a premium of approximately 32.5 % over the closing price of the Company’s common stock on May 8, 2023. The Notes will mature on June 1, 2028 , unless earlier repurchased, redeemed or converted. The Company used $ 52.1 million of the proceeds from the sale of the Notes to fund the cost of entering into capped call transactions, described below. The proceeds from the issuance of the Notes were approximately $ 393.3 million, net of capped call transaction costs of $ 52.1 million and initial purchaser discounts and other debt issuance costs totaling $ 14.6 million. The Notes bear interest at a rate of 1.50 % per year and interest is payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2023 . The initial conversion rate is 10.6388 shares of common stock per $ 1,000 principal amount of the Notes, which represents an initial conversion price of approximately $ 94.00 per share of common stock. The conversion rate and conversion price are subject to customary adjustments upon the occurrence of certain events as described in the Indenture. Before March 1, 2028 , noteholders have the right to convert their Notes only upon the occurrence of certain events, including certain corporate events, and during the five business days immediately after any ten consecutive trading days in which the trading price per $ 1,000 principal amount of Notes is less than ninety eight percent ( 98 %) of the as converted value. Additionally, the noteholder can convert their Notes during any calendar quarter (and only during such calendar quarter), commencing after the calendar quarter ending on September 30, 2023 but before March 1, 2028 , provided the last reported sale price of the common stock for at least 20 trading days is greater than or equal to 130 % of the conversion price during the 30 consecutive trading days ending on the last trading day of a calendar quarter. From and after March 1, 2028, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. The Company has the right to elect to settle conversions either in cash, shares or in a combination of cash and shares of its common stock. Prior to June 8, 2026, the Notes will not be redeemable. On or after June 8, 2026, the Company may redeem for cash all or any portion of the Notes (subject to the partial redemption limitation set forth in the Indenture), at its option, if the last reported sale price of the Company’s common stock has been at least 130 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. In addition, calling any Note for redemption will constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption. The Company accounts for the Notes as a single liability in accordance with ASC 470-20 as the Company concluded that embedded conversion features within the Notes do not meet the requirements for bifurcation. Initial purchaser discounts and other debt issuance costs related to the Notes totaling $ 14.6 million were recorded by the Company as a debt discount. The debt discount is reflected as a reduction of the carrying value of the Notes on the Company’s consolidated balance sheet and is being accreted to interest expense over the term of the Notes using the effective interest method. During the three and nine months ended September 30, 2023, the Company recognized $ 2.4 million and $ 3.8 million, respectively, in interest expense related to the 1.50 % cash coupon of the Notes and amortization of the debt issuance costs. During the three and nine months ended September 30, 2023, the effective interest rate on the outstanding Notes was approximately 2.1 %. Capped Call Transactions In connection with the offering of the Notes, the Company entered into privately negotiated capped call transactions (the “Capped Calls”) with certain financial institution counterparties (the “Option Counterparties”). The Capped Calls are generally intended to reduce or offset the potential dilution to the common stock upon any conversion of the Notes with such reduction or offset, as the case may be, subject to a cap based on the cap price. For accounting purposes, the Capped Calls are separate transactions, and not part of the terms of the Notes. The Capped Calls are recorded in stockholders’ equity and are not accounted for as derivatives. The cost of $ 52.1 million incurred to purchase the Capped Calls were recorded as a reduction to common stock in the accompanying consolidated balance sheet. Each of the Capped Calls has an initial strike price of approximately $ 94.00 per share, subject to certain adjustments, which corresponds to the initial conversion price of the Notes. The Capped Calls have an initial cap price of $ 141.88 per share, subject to certain adjustments. The Capped Calls cover, subject to anti-dilution adjustments, approximately 4,893,848 million shares of the Company’s common stock, which is the same number of shares of the Company’s common stock initially underlying the Notes. The Capped Calls are subject to automatic exercise over a 40 trading day period commencing on April 3, 2028 , subject to earlier termination under certain circumstances. Long-term debt Long-term debt consisted of the following (in thousands): September 30, 2023 December 31, 2022 Principal amount of long-term debt $ 60,000 $ 60,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 60,000 60,000 Debt discount, net of accretion ( 1,014 ) ( 1,304 ) Long-term debt, net of discount and current portion $ 58,986 $ 58,696 In July 2022, the Company entered into a credit agreement with Canadian Imperial Bank of Commerce (“CIBC”), as amended by the First Amendment to Credit Agreement, dated as of May 8, 2023, by and among the Company and CIBC (the “First Amendment”) and the Second Amendment to Credit Agreement, dated as of June 23, 2023, by and among the Company, and CIBC (the “Second Amendment”) (as amended, the “CIBC Credit Agreement”), pursuant to which the Company borrowed $ 60.0 million. In connection with the CIBC Credit Agreement, the Company repaid all amounts due under its previously outstanding credit agreement with OrbiMed Royalty Opportunities II, LP, including $ 35.0 million of principal repayments and a $ 1.1 million end of term payment, as well as accrued interest and the OrbiMed Credit Agreement was terminated. Upon repayment of the outstanding amounts, the Company recorded a loss on extinguishment of debt of $ 0.6 million, which was classified as other expense in the consolidated statements of operations. On May 8, 2023, the Company entered into the First Amendment, which among other items, allowed for the issuance of the Notes and Capped Calls. On June 23, 2023, the Company entered into the Second Amendment, which among other items, permits the Company to make acquisitions of equity or assets of another entity, subject to the conditions under the Second Amendment, including acquisitions, without further consent of CIBC, up to a maximum amount of $ 50.0 million for the cash consideration payable in connection with an individual acquisition and a maximum amount of $ 150.0 million for the total cash consideration payable for all acquisitions made by the Company on or after June 23, 2023. The definition of consolidated adjusted EBITDA was also amended to add a provision for the pro forma effect of any acquisitions that occur during the period. Additionally, pursuant to the Second Amendment, the parties agreed to extend the start of the principal repayment period to July 31, 2026, on which date the Company is obligated to begin repayment of the term loans in equal monthly installments until the maturity date in July 2027. Borrowings under the CIBC Credit Agreement bear interest at an annual rate equal to either, at the Company’s option, (i) the secured overnight financing rate for an interest period selected by the Company, subject to a minimum of 1.50 %, plus 2.0 % or (ii) 1.0 % plus the higher of a) the prime rate subject to a minimum of 4.0 % or b) the Federal Funds Effective Rate, plus 0.5 %. At the Company’s option, the Company may prepay borrowings outstanding under the CIBC Credit Agreement, subject to a prepayment fee of 2.0 % of outstanding borrowings if paid prior to 12 months after the closing date, and 1.0 % if paid on or after 12 months after the closing date but prior to 24 months after the closing date. In connection with entering into the CIBC Credit Agreement, the Company paid upfront fees and other costs of $ 1.5 million, which were recorded by the Company as a debt discount. The debt discount is reflected as a reduction of the carrying value of long-term debt on the Company’s consolidated balance sheet and is being accreted to interest expense over the term of the CIBC Credit Agreement using the effective interest method. All obligations under the CIBC Credit Agreement are guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor are secured by substantially all of the Company’s and each guarantor’s assets, including their intellectual property, subject to certain exceptions. Under the CIBC Credit Agreement, the Company has agreed to customary representations and warranties, events of default and certain affirmative and negative covenants to which it will remain subject until maturity. The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain) for the trailing four month period (only if EBITDA is negative) and (ii) $ 10.0 million, and (y) a requirement to maintain total net revenue of at least 75 % of the level set forth in the total revenue plan presented to CIBC. As discussed above, the definition of consolidated adjusted EBITDA was amended to include the pro forma effect of acquisitions. The obligations under the CIBC Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in the Company’s business), failure to comply with certain covenants and a material adverse change in the Company’s business, operations or financial condition. As of September 30, 2023, the Company was in compliance with all financial covenants of the CIBC Credit Agreement. During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0 %. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, CIBC may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, the Company may be required to prepay outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events. The Company assessed all terms and features of the CIBC Credit Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the debt. The Company determined that all features of the CIBC Credit Agreement are either clearly and closely associated with a debt host or have a de minimis fair value and, as such, do not require separate accounting as a derivative liability. As of September 30, 2023 , the stated interest rate applicable to borrowings under the CIBC Credit Agreement was 7.3 % . During the three and nine months ended September 30, 2023, the weighted average effective interest rate on outstanding borrowings under the CIBC Credit Agreement was approximately 7.7 % and 7.6 % , respectively. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation 2019 Stock Incentive Plan The Company’s 2019 Stock Incentive Plan (the “2019 Plan”) provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, unrestricted stock units, and other stock-based awards to employees, directors, and consultants of the Company and its subsidiaries. The number of shares of common stock of TransMedics Group initially available for issuance under the 2019 Plan was 3,428,571 shares, plus the number of shares underlying awards under the previously outstanding 2014 Stock Incentive Plan (the “2014 Plan”), not to exceed 1,595,189 shares, that expire or are terminated, surrendered, or canceled without the delivery of shares, are forfeited to or repurchased by TransMedics Group or otherwise become available again for grant. Since the effectiveness of the Company’s 2019 Plan in April 2019, no awards have been or will be made under the 2014 Plan. Shares withheld in payment of the exercise or purchase price of an award or in satisfaction of tax withholding requirements, and the shares covered by a stock appreciation right for which any portion is settled in stock, will reduce the number of shares available for issuance under the 2019 Plan. In addition, the number of shares available for issuance under the 2019 Plan (i) will not be increased by any shares delivered under the 2019 Plan that are subsequently repurchased using proceeds directly attributable to stock option exercises and (ii) will not be reduced by any awards that are settled in cash or that expire, become unexercisable, terminate or are forfeited to or repurchased by TransMedics Group without the issuance of stock under the 2019 Plan. On May 25, 2023, the shareholders of the Company approved the Amended and Restated TransMedics Group, Inc. 2019 Stock Incentive Plan (the “Amended Plan”) to among other things, (i) increase the number of shares of the Company’s common stock available for issuance thereunder by 1,000,000 shares, (ii) prohibit the payment of dividend or dividend equivalents on a current basis with respect to unvested awards, (iii) extend the expiration date of the Amended Plan until June 1, 2033 and (iv) increase the annual limits on non-employee director compensation. As of September 30, 2023, 1,389,390 shares of common stock were available for issuance under the Amended Plan. 2019 Employee Stock Purchase Plan Pursuant to the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”), certain employees of the Company are eligible to purchase common stock of the Company at a reduced price during offering periods. The 2019 ESPP permits participants to purchase common stock using funds contributed through payroll deductions, subject to the limitations set forth in the Internal Revenue Code, at a purchase price of 85 % of the lower of the closing price of the Company’s common stock on the first trading day of the offering period or the closing price on the applicable purchase date, which is the final trading day of the applicable offering period. A total of 371,142 shares of the Company’s common stock were initially reserved for issuance under the 2019 ESPP. During the nine months ended September 30, 2023 , 25,894 shares of common stock were issued under the 2019 ESPP and as of September 30, 2023 , 264,559 shares of common stock remained available for issuance. 2021 Inducement Plan In August 2021, the Company’s board of directors approved the TransMedics Group, Inc. Inducement Plan (the “Inducement Plan”). Pursuant to the terms of the Inducement Plan, the Company may grant nonqualified stock options, stock appreciation rights, restricted stock, unrestricted stock, restricted stock unit awards and performance awards to individuals who were not previously employees or directors of the Company or individuals returning to employment after a bona fide period of non-employment with the Company. A total of 1,000,000 shares of the Company’s common stock were initially available for issuance under the Inducement Plan. As of September 30, 2023, 290,719 shares of common stock remained available for issuance under the Inducement Plan. Stock Option Activity During the nine months ended September 30, 2023, the Company granted options under the 2019 Plan and the Inducement Plan with service-based vesting for the purchase of an aggregate of 473,346 shares of common stock with a weighted average grant-date fair value of $ 45.49 per share. Restricted Stock Unit Activity During the nine months ended September 30, 2023, the Company granted 251,384 restricted stock units under the 2019 Plan and the Inducement Plan with service-based vesting conditions and a weighted-average grant-date fair value of $ 70.21 per share. Stock-Based Compensation The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of revenue $ 112 $ 33 $ 241 $ 89 Research, development and clinical trials expenses 781 394 2,013 1,079 Selling, general and administrative expenses 4,295 2,277 11,813 6,162 $ 5,188 $ 2,704 $ 14,067 $ 7,330 As of September 30, 2023, total unrecognized compensation cost related to unvested share-based awards was $ 46.2 million, which is expected to be recognized over a weighted average period of 2.5 years. |
Asset Acquisition
Asset Acquisition | 9 Months Ended |
Sep. 30, 2023 | |
Asset Acquisition [Abstract] | |
Asset Acquisition | 11. Asset Acquisition On August 2, 2023 , the Company acquired certain assets related to lung and heart perfusion technology from Bridge to Life Ltd. and its subsidiary Tevosol, Inc., together (“BTL”). The Company intends to further develop these technologies to expand its product offerings and indications for organ transplantation. The Company accounted for the purchase of BTL as an asset acquisition as substantially all of the fair value of gross assets acquired were concentrated on a single set of identifiable activities consisting of lung and heart perfusion technology, referred to as the in-process research and development (“IPR&D”) asset. Due to the stage of development of the IPR&D asset at the date of acquisition, it was not yet probable that there was future economic benefit from this asset. Absent successful clinical results and regulatory approval for the asset applications, there was no alternative future use associated with the asset. Accordingly, the value of the IPR&D asset was expensed as research and development expense in the consolidated statements of operations for the three and nine months ended September 30, 2023. Total IPR&D expense related to this acquisition was $ 27.2 million. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Operating Leases The Company leases office, laboratory and manufacturing space under two non-cancelable operating leases. In June 2023, the Company amended one of its lease agreements to add space, resulting in additional lease payments of approximately $ 2.6 million over the remaining term of the leases. There have been no other material changes to the Company’s leases during the nine months ended September 30, 2023. For additional information, please read Note 12 Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2022. 401(k) Savings Plan The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. As of December 31, 2022 , the Company had no t made any contributions to the plan. Effective January 1, 2023, the Company instituted an employer matching program for the 401(k) Plan pursuant to which the Company will match 100 % of the first 3 % of each participating employee’s eligible compensation contributed to the plan and 50 % of up to an additional 2 % each participating employee’s eligible compensation contributed to the plan. For the three and nine months ended September 30, 2023, the Company recorded expense of $ 0.3 million and $ 1.0 million, respectively, related to these matching contributions. Indemnification Agreements In the ordinary course of business, the Company has agreed to defend and indemnify its customers against third-party claims asserting infringement of certain intellectual property rights, which may include patents, copyrights, trademarks, or trade secrets. The Company’s exposure under these indemnification provisions is generally limited to the total amount paid by the end-customer under the agreement. However, certain agreements include indemnification provisions that could potentially expose the Company to losses in excess of the amount received under the agreement. In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and had not accrued any liabilities related to such obligations in its consolidated financial statements as of September 30, 2023 and December 31, 2022. Unconditional Purchase Commitment In January 2021, the Company entered into an unconditional $ 9.5 million purchase commitment, in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029 . The contract is not cancellable without penalty. The remaining purchase commitment as of September 30, 2023 was $ 7.0 million. Legal Proceedings The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Segment Reporting and Geographi
Segment Reporting and Geographic Data | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Segment Reporting and Geographic Data | 13. Segment Reporting and Geographic Data The Company has determined that it operates in one segment (see Note 2). See Note 14 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands): September 30, 2023 December 31, 2022 Long-lived assets by country(1): United States $ 130,214 $ 18,568 All other countries 790 655 Total long-lived assets $ 131,004 $ 19,223 (1) Long-lived assets consist of property, plant and equipment, net of depreciation, which are categorized based on their location of domicile. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 14. Revenue Payments to Customers The Company has determined that the payments made to the customer for reimbursement of clinical trial materials and customer’s costs incurred to execute specific clinical trial protocols related to the Company’s OCS products do not provide the Company with a distinct good or service transferred by the customer, and therefore such payments are recorded as a reduction of revenue from the customer in the Company’s consolidated statements of operations. The Company records the reduction of revenue in the same period as the revenue is recognized and records a corresponding accrual for its estimate of the payments. As clinical trials reach the closeout phase, the Company updates its accrual estimates with corresponding adjustments to revenue. The net impact of such adjustments were insignificant in each of the three and nine months ended September 30, 2023 and 2022. The Company will continue to update its clinical trial accrual estimates as information related to clinical trial payments is received. The Company determined that payments made to customers to obtain information related to post-approval studies or existing standard-of-care protocols (i.e., unrelated to the Company’s OCS products) meet the criteria to be classified as a cost because the Company receives a distinct good or service transferred by the customer separate from the customer’s purchase of the Company’s OCS products and the consideration paid to the customer represents the fair value of the distinct good or service received. As a result, such payments made to the customers are recorded as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $ 0.4 million and $ 0.5 million for the three months ended September 30, 2023 and 2022 , respectively, and $ 0.8 million and $ 1.0 million for the nine months ended September 30, 2023 and 2022, respectively, as operating expenses. Summit makes payments to its aircraft management customers who had opted in to Summit's charter program. Summit pays the aircraft owner a fee for the use of the aircraft for charter flight services. The Company determined that fees incurred for the use of aircraft management customers' aircraft 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 Summit's aircraft management services and the consideration to the customer represents the fair value of the distinct good or service received. As a result, such fees are recorded as cost of sales. The Company recorded expense for the use of customers' aircraft of $ 0.7 million for the three and nine months ended September 30, 2023. As part of the Summit integration, Summit's legacy aircraft management customers are being transitioned to third parties and following this transition, the Company will no longer make such payments to customers. Disaggregated Revenue The Company disaggregates revenue from contracts with customers related to OCS transplant by organ type and geographical area as it believes this presentation best depicts how the nature, amount, timing and uncertainty of the Company’s revenue and cash flows are affected by economic factors, as shown below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 OCS Transplant Revenue by country United States Lung total revenue $ 3,410 $ 1,438 $ 7,658 $ 6,033 Heart total revenue 15,069 9,304 41,481 18,921 Liver total revenue 41,214 12,543 97,002 30,030 Total United States OCS transplant 59,693 23,285 146,141 54,984 All other countries Lung revenue 310 161 964 703 Heart revenue 3,893 2,237 10,803 6,397 Liver revenue 97 — 104 — Total all other countries OCS 4,300 2,398 11,871 7,100 Total OCS transplant revenue $ 63,993 $ 25,683 $ 158,012 $ 62,084 (1) Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. (2) Service revenue unrelated to OCS transplant, which was $ 2.4 million for each of the three and nine months ended September 30, 2023 and none for the three and nine months ended September 30, 2022, is not included in this table. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions Employment of Dr. Amira Hassanein Dr. Amira Hassanein, who serves as Product Director for the Company’s OCS Lung program, is the sister of Dr. Waleed Hassanein, the Company’s President and Chief Executive Officer and a member of the Company’s board of directors. The Company paid Dr. Amira Hassanein approximately $ 0.1 million in total compensation for each of the three months ended September 30, 2023 and 2022, for her services as an employee. The Company paid Dr. Amira Hassanein approximately $ 0.3 million in total compensation for each of the nine months ended September 30, 2023 and 2022 , for her services as an employee. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2023 and results of operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022 have been made. The Company’s results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited consolidated financial statements include, but are not limited to, revenue recognition, the valuation of inventory, the valuation of assets acquired and liabilities assumed in business combinations, including acquired intangible assets and the resulting goodwill, and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. As of the date of issuance of these unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions. |
Risk of Concentrations of Credit, Significant Customers and Significant Suppliers | Risk of Concentrations of Credit, Significant Customers and Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and accounts receivable. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of September 30, 2023 and December 31, 2022, the Company had no allowance for credit losses. Significant customers are those that accounted for 10 % or more of the Company’s revenue or accounts receivable. For the three and nine months ended September 30, 2023 , no customer accounted for more than 10 % of revenue. For the three months ended September 30, 2022 , one customer accounted for 13 % of revenue. For the nine months ended September 30, 2022 , one customer accounted for 15 % of revenue. As of September 30, 2023 one customer accounted for 13 % of accounts receivable. As of December 31, 2022 , no customer accounted for more than 10 % of accounts receivable. Certain of the components and subassemblies included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers, as are sterilization services. Although the Company seeks to reduce dependence on those limited sources of suppliers, manufacturers and service providers, the partial or complete loss of certain of these sources could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships. |
Business Combinations | Business Combinations In determining whether an acquisition should be accounted for as a business combination or asset acquisition, the Company first determines whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets. If this is the case, the single identifiable asset or the group of similar assets is not deemed to be a business and the acquisition is accounted for as an asset acquisition. If this is not the case, the Company then further evaluates whether the acquisition includes, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. If so, the Company concludes that the acquisition is a business and accounts for it as a business combination. The Company accounts for business combinations using the acquisition method of accounting. In accordance with this method, assets acquired and liabilities assumed are recorded at their respective fair values at the acquisition date. The fair value of the consideration paid is assigned to the assets acquired and liabilities assumed based on their respective fair values. Goodwill represents the excess of the purchase price over the estimated fair values of the assets acquired and liabilities assumed. Determining the fair value of assets acquired and liabilities assumed is judgmental in nature and can involve the use of significant estimates and assumptions. Fair value and useful life determinations are based on, among other things, valuations that use information and assumptions provided by management, which consider management’s best estimates of inputs and assumptions that a market participant would use. Actual results may vary from these estimates and may result in adjustments to goodwill and acquisition date fair values of assets and liabilities during a measurement period or upon a final determination of asset and liability fair values, whichever comes first. Adjustments to fair values of assets and liabilities made after the end of the measurement period are recorded within operating results. Transaction costs related to business combinations are expensed as incurred and are included in general and administrative expense in the consolidated statements of operations. |
Asset Acquisitions | Asset Acquisitions The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the asset or group of assets, which includes transaction costs. Goodwill is not recognized in asset acquisitions. In an asset acquisition, the cost allocated to acquire in-process research and development (“IPR&D”) with no alternative future use is charged to expense at the acquisition date. |
Goodwill and Acquired Intangible Assets | Goodwill and Acquired Intangible Assets The Company records goodwill when consideration paid in a business combination exceeds the value of the net assets acquired. The Company’s estimates of fair value are based upon assumptions believed to be reasonable at that time, but that are inherently uncertain and unpredictable. Goodwill is not amortized, but rather is tested for impairment annually in the fourth quarter, or more frequently if facts and circumstances warrant a review, such as significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. The Company has determined that there is a single reporting unit for the purpose of conducting this goodwill impairment assessment. The Company has the option of performing either a qualitative or quantitative assessment to determine whether further impairment testing is necessary. If it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount, a quantitative impairment test will be required. The quantitative goodwill impairment test requires management to estimate and compare the fair value of the reporting unit with its carrying value. If the fair value of the reporting unit exceeds the carrying value of the net assets, goodwill is not impaired. If the fair value of the reporting unit is less than the carrying value, the difference is recorded as an impairment loss up to the amount of goodwill. Intangible assets are recorded at their estimated fair values at the date of acquisition and are reported net of accumulated amortization. The Company amortizes acquired intangible assets with finite lives over their estimated useful lives based on the pattern of consumption of the economic benefits or, if that pattern cannot be readily determined, on a straight-line basis. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate. The Company's 1.50 % Convertible Senior Notes due 2028 (the "Notes") are carried at the face value less unamortized debt discount and issuance costs on the consolidated balance sheets, and the fair value of the convertible senior notes is presented at each reporting period for disclosure purposes only. |
Segment Information | Segment Information The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company has developed and is commercializing a proprietary system to preserve and deliver human organs for transplant in a near-physiologic condition to address the limitations of cold storage organ preservation. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding common stock equivalents. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three and nine months ended September 30, 2023 and 2022. The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 3,191,755 3,309,558 Employee stock purchase plan 9,370 8,886 Restricted stock units 241,167 — Restricted stock awards 9,772 24,315 Convertible senior notes 4,893,848 — 8,410,352 3,407,199 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Warrants to purchase common stock 64,440 64,440 Options to purchase common stock 3,191,755 3,309,558 Employee stock purchase plan 9,370 8,886 Restricted stock units 241,167 — Restricted stock awards 9,772 24,315 Convertible senior notes 4,893,848 — 8,410,352 3,407,199 |
Acquisition of Summit (Tables)
Acquisition of Summit (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Business Combinations [Abstract] | |
Summary of Assets Acquired and Liabilities Assumed | The following tables summarize the preliminary allocation of the purchase price (in thousands): Assets Acquired and Liabilities Assumed: Accounts receivable $ 2,089 Other current assets 1,040 Property, plant and equipment 5,922 Right-of-use asset 288 Intangible assets 2,430 Goodwill 11,673 Total assets acquired 23,442 Accounts payable and other current liabilities ( 6,720 ) Deferred tax liabilities ( 1,540 ) Operating lease liabilities ( 288 ) Total allocation of purchase price consideration, $ 14,894 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consisted of the following (in thousands): September 30, 2023 December 31, 2022 Raw materials $ 18,856 $ 10,939 Work-in-process 3,051 1,876 Finished goods 17,458 7,790 $ 39,365 $ 20,605 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | Property, plant and equipment, net consisted of the following (in thousands): September 30, 2023 December 31, 2022 Transplant aircraft $ 102,985 $ — Flight school aircraft 3,484 — OCS Consoles 13,074 10,878 Manufacturing equipment 5,315 3,721 Computer equipment and software 2,782 2,064 Laboratory equipment 765 671 Office, trade show and training equipment 3,030 2,121 Leasehold improvements 12,917 12,415 Construction-in-progress 4,308 482 148,660 32,352 Less: Accumulated depreciation and amortization ( 17,656 ) ( 13,129 ) $ 131,004 $ 19,223 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Acquired Intangible Assets | Acquired intangible assets consisted of the following (in thousands): September 30, 2023 Weighted Average Useful Life Gross Amount Accumulated Amortization Carrying Value (in years) Customer relationship 12 $ 2,320 $ 24 $ 2,296 Other 12 110 1 109 $ 2,430 $ 25 $ 2,405 |
Future Amortization Expense of Intangible Assets | Future amortization expense of the intangible assets as of September 30, 2023, is expected to be as follows (in thousands): Year Ending December 31, 2023 (three months) $ 49 2024 203 2025 203 2026 203 2027 203 Thereafter 1,544 $ 2,405 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2023 December 31, 2022 Accrued payroll and related expenses $ 15,934 $ 9,812 Accrued transportation costs 4,375 2,581 Accrued research, development and clinical trials expenses 1,261 1,876 Accrued professional fees 2,073 965 Accrued interest 2,683 — Accrued other 5,325 3,401 $ 31,651 $ 18,635 |
Long-term Debt and Financing _2
Long-term Debt and Financing Arrangements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Convertible Senior Notes | Convertible senior notes consisted of the following (in thousands): September 30, 2023 Principal amount of convertible senior notes $ 460,000 Less: Current portion of convertible senior notes — Convertible senior notes, net of current portion 460,000 Debt discount, net of accretion ( 13,552 ) Convertible senior notes, net of discount and current portion $ 446,448 |
Schedule of Long-Term Debt Instruments | Long-term debt consisted of the following (in thousands): September 30, 2023 December 31, 2022 Principal amount of long-term debt $ 60,000 $ 60,000 Less: Current portion of long-term debt — — Long-term debt, net of current portion 60,000 60,000 Debt discount, net of accretion ( 1,014 ) ( 1,304 ) Long-term debt, net of discount and current portion $ 58,986 $ 58,696 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Stock-Based Compensation Expense | The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of revenue $ 112 $ 33 $ 241 $ 89 Research, development and clinical trials expenses 781 394 2,013 1,079 Selling, general and administrative expenses 4,295 2,277 11,813 6,162 $ 5,188 $ 2,704 $ 14,067 $ 7,330 |
Segment Reporting and Geograp_2
Segment Reporting and Geographic Data (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Long-lived assets by geographical area | See Note 14 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands): September 30, 2023 December 31, 2022 Long-lived assets by country(1): United States $ 130,214 $ 18,568 All other countries 790 655 Total long-lived assets $ 131,004 $ 19,223 (1) Long-lived assets consist of property, plant and equipment, net of depreciation, which are categorized based on their location of domicile. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Net Revenue by Organ and Country | The Company disaggregates revenue from contracts with customers related to OCS transplant by organ type and geographical area as it believes this presentation best depicts how the nature, amount, timing and uncertainty of the Company’s revenue and cash flows are affected by economic factors, as shown below (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 OCS Transplant Revenue by country United States Lung total revenue $ 3,410 $ 1,438 $ 7,658 $ 6,033 Heart total revenue 15,069 9,304 41,481 18,921 Liver total revenue 41,214 12,543 97,002 30,030 Total United States OCS transplant 59,693 23,285 146,141 54,984 All other countries Lung revenue 310 161 964 703 Heart revenue 3,893 2,237 10,803 6,397 Liver revenue 97 — 104 — Total all other countries OCS 4,300 2,398 11,871 7,100 Total OCS transplant revenue $ 63,993 $ 25,683 $ 158,012 $ 62,084 (1) Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. (2) Service revenue unrelated to OCS transplant, which was $ 2.4 million for each of the three and nine months ended September 30, 2023 and none for the three and nine months ended September 30, 2022, is not included in this table. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||||||||
Net loss | $ 25,422 | $ 1,001 | $ 2,636 | $ 7,426 | $ 11,523 | $ 10,562 | $ 29,059 | $ 29,511 | $ 36,200 |
Accumulated deficit | 507,736 | 507,736 | 478,677 | ||||||
Cash | $ 427,110 | $ 427,110 | $ 201,182 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 | Sep. 30, 2023 USD ($) Segment | Sep. 30, 2022 | Dec. 31, 2022 USD ($) | |
Allowance for credit losses | $ | $ 0 | $ 0 | $ 0 | ||
Number of operating segments | Segment | 1 | ||||
Convertible Senior Notes Due 2028 [Member] | |||||
Debt instrument, interest rate | 1.50% | 1.50% | |||
Customer Concentration Risk | Revenue Benchmark | Significant Customer Benchmark [Member] | Minimum [Member] | |||||
Concentration risk percentage | 10% | 10% | |||
Customer Concentration Risk | Revenue Benchmark | Customer One [Member] | |||||
Concentration risk percentage | 13% | 15% | |||
Customer Concentration Risk | Accounts Receivable | Significant Customer Benchmark [Member] | Minimum [Member] | |||||
Concentration risk percentage | 10% | 10% | |||
Customer Concentration Risk | Accounts Receivable | Customer One [Member] | Minimum [Member] | |||||
Concentration risk percentage | 13% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 8,410,352 | 3,407,199 |
Warrants to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 64,440 | 64,440 |
Options to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 3,191,755 | 3,309,558 |
Employee stock purchase plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 9,370 | 8,886 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 241,167 | |
Restricted stock awards [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 9,772 | 24,315 |
Convertible Senior Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share Amount | 4,893,848 |
Marketable Securities and Fai_2
Marketable Securities and Fair Value Measurements - Additional Information (Detail) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities and Fair Value Measurements [Abstract] | ||
Marketable Securities | $ 0 | $ 0 |
Assets measured at fair value | 0 | 0 |
Liabilities measured at fair value | 0 | $ 0 |
Carrying value of convertible senior notes | 446,448,000 | |
Estimated fair value of convertible senior notes | $ 426,200,000 |
Acquisition of Summit - Additio
Acquisition of Summit - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Aug. 16, 2023 | Sep. 30, 2023 | |
Business Acquisition [Line Items] | ||
Upfront cash payment | $ 14,894,000 | |
Summit [Member] | ||
Business Acquisition [Line Items] | ||
Acquisition date | Aug. 16, 2023 | |
Preliminary purchase consideration | $ 14,894,000 | |
Upfront cash payment | 18,000,000 | |
Intangible assets | 2,430,000 | |
Goodwill resulting from the acquisition deductible for tax purposes | 0 | |
Tax benefit | 1,500,000 | |
Transaction costs | 2,000,000 | |
Summit [Member] | Customer Relationship Asset [Member] | ||
Business Acquisition [Line Items] | ||
Intangible assets | $ 2,300,000 | |
Estimated useful life | 12 years |
Acquisition of Summit - Summary
Acquisition of Summit - Summary of Assets Acquired and Liabilities Assumed (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Aug. 16, 2023 |
Business Acquisition [Line Items] | ||
Goodwill | $ 11,673 | |
Summit [Member] | ||
Business Acquisition [Line Items] | ||
Accounts receivable | $ 2,089 | |
Other current assets | 1,040 | |
Property, plant and equipment | 5,922 | |
Right-of-use asset | 288 | |
Intangible assets | 2,430 | |
Goodwill | $ 11,700 | 11,673 |
Total assets acquired | 23,442 | |
Accounts payable and other current liabilities | (6,720) | |
Deferred tax liabilities | (1,540) | |
Operating lease liabilities | (288) | |
Total allocation of purchase price consideration, net of cash acquired | $ 14,894 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 18,856 | $ 10,939 |
Work-in-process | 3,051 | 1,876 |
Finished goods | 17,458 | 7,790 |
Inventory, net | $ 39,365 | $ 20,605 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 148,660 | $ 32,352 |
Less: Accumulated depreciation and amortization | (17,656) | (13,129) |
Property, plant and equipment, net | 131,004 | 19,223 |
Transplant Aicraft [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 102,985 | |
Flight School Aircraft [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,484 | |
OCS Consoles [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 13,074 | 10,878 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 5,315 | 3,721 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,782 | 2,064 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 765 | 671 |
Office, Trade Show and Training Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 3,030 | 2,121 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 12,917 | 12,415 |
Construction-In-Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 4,308 | $ 482 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2023 | |
Transplant Aicraft [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of aircarft | 10 years |
Flight School Aircraft [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of aircarft | 5 years |
Transplant Aircraft and Flight School Aircraft [Member] | |
Property, Plant and Equipment [Line Items] | |
Residual value percentage | 50% |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Aug. 16, 2023 | |
Goodwill [Line Items] | ||
Carrying amount of goodwill | $ 11,673,000 | |
Impairments to goodwill | 0 | |
Summit [Member] | ||
Goodwill [Line Items] | ||
Carrying amount of goodwill | $ 11,700,000 | $ 11,673,000 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of Acquired Intangible Assets (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Amount | $ 2,430 |
Accumulated Amortization | 25 |
Carrying Value | $ 2,405 |
Customer Relationship [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted Average Useful Life (in years) | 12 years |
Gross Amount | $ 2,320 |
Accumulated Amortization | 24 |
Carrying Value | $ 2,296 |
Other [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Weighted Average Useful Life (in years) | 12 years |
Gross Amount | $ 110 |
Accumulated Amortization | 1 |
Carrying Value | $ 109 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Future Amortization Expense of Intangible Assets (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2023 (three months) | $ 49 |
2024 | 203 |
2025 | 203 |
2026 | 203 |
2027 | 203 |
Thereafter | 1,544 |
Carrying Value | $ 2,405 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses And Other Current Liabilities [Abstract] | ||
Accrued payroll and related expenses | $ 15,934 | $ 9,812 |
Accrued transportation costs | 4,375 | 2,581 |
Accrued research, development and clinical trials expenses | 1,261 | 1,876 |
Accrued professional fees | 2,073 | 965 |
Accrued interest | 2,683 | |
Accrued other | 5,325 | 3,401 |
Accrued expenses and other liabilities current | $ 31,651 | $ 18,635 |
Long-term Debt and Financing _3
Long-term Debt and Financing Arrangements - Schedule of Convertible Senior Notes (Detail) $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Instrument [Line Items] | |
Convertible senior notes, net of discount and current portion | $ 446,448 |
Convertible Debt [Member] | |
Debt Instrument [Line Items] | |
Principal amount | 460,000 |
Net of current portion | 460,000 |
Debt discount, net of accretion | $ (13,552) |
Long-term Debt and Financing _4
Long-term Debt and Financing Arrangements - Convertible Senior Notes - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||
May 11, 2023 USD ($) TradingDays $ / shares shares | May 08, 2023 | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||
Proceeds from Convertible Debt | $ 445,380,000 | |||
Debt instrument, frequency of periodic payment | semiannually | |||
Debt instrument, date of first required payment | Dec. 01, 2023 | |||
Convertible Senior Notes [Member] | ||||
Debt Instrument [Line Items] | ||||
Conversion price per share | $ / shares | $ 94 | |||
Premium percentage over closing price | 32.50% | |||
Maturity date of notes | Jun. 01, 2028 | |||
Interest expense, debt | $ 2,400,000 | $ 3,800,000 | ||
Percentage of cash coupon of notes and amortization of the debt issuance costs | 1.50% | 1.50% | ||
Proceeds from Convertible Debt | $ 393,300,000 | |||
Capped call transaction costs net | 52,100,000 | |||
Purchase discounts and other debt issuance costs | $ 14,600,000 | |||
Debt instrument, interest rate | 1.50% | |||
Debt instrument interest payable description | The Notes bear interest at a rate of 1.50% per year and interest is payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2023. | |||
Conversion of per principal amount of notes | $ 1,000 | |||
Average effective interest rate | 2.10% | 2.10% | ||
Convertible Senior Notes [Member] | Used To Fund Capped Call Transactions [Member] | ||||
Debt Instrument [Line Items] | ||||
Proceeds from Convertible Debt | $ 52,100,000 | |||
Convertible Senior Notes [Member] | Per One Thousand Dollars [Member] | ||||
Debt Instrument [Line Items] | ||||
Initial conversion rate shares of common stock | shares | 10.6388 | |||
Convertible Senior Notes [Member] | Before March 1, 2028 [Member] | ||||
Debt Instrument [Line Items] | ||||
Conversion of per principal amount of notes | $ 1,000 | |||
Debt instrument, redemption period, end date | Mar. 01, 2028 | |||
Number of trading days | TradingDays | 5 | |||
Number of consecutive trading days | TradingDays | 10 | |||
Convertible Senior Notes [Member] | Calendar Quarter Ending on September 30, 2023 but Before March 1, 2028 [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, redemption period, start date | Sep. 30, 2023 | |||
Debt instrument, redemption period, end date | Mar. 01, 2028 | |||
Number of trading days | TradingDays | 20 | |||
Number of consecutive trading days | TradingDays | 30 | |||
Conversion price | 130% | |||
Convertible Senior Notes [Member] | On or After June 8 2026 [Member] | Redeemable Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Number of trading days | TradingDays | 20 | |||
Number of consecutive trading days | TradingDays | 30 | |||
Conversion price | 130% | |||
Convertible Senior Notes [Member] | Maximum [Member] | Before March 1, 2028 [Member] | ||||
Debt Instrument [Line Items] | ||||
Conversion price | 98% | |||
Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 460,000,000 | $ 460,000,000 | ||
Private Placement [Member] | Convertible Debt [Member] | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 460,000,000 |
Long-term Debt and Financing _5
Long-term Debt and Financing Arrangements - Capped Call Transactions - Additional Information (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended | |
May 11, 2023 USD ($) | Sep. 30, 2023 USD ($) TradingDays $ / shares shares | |
Debt Instrument [Line Items] | ||
Purchases of capped calls related to convertible senior notes | $ | $ 52,072 | |
Capped Calls [Member] | ||
Debt Instrument [Line Items] | ||
Purchases of capped calls related to convertible senior notes | $ | $ 52,100 | |
Initial conversion price/rate | $ / shares | $ 94 | |
Capped calls, initial cap price per share | $ / shares | 141.88 | |
Capped calls, subject to anti-dilution adjustments | shares | 4,893,848 | |
Number of trading days subject to automatic exercise | TradingDays | 40 | |
Trading day period, commencing date | Apr. 03, 2028 |
Long-term Debt and Financing _6
Long-term Debt and Financing Arrangements - Schedule of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Net of discount and current portion | $ 58,986 | $ 58,696 |
Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Principal amount | 60,000 | 60,000 |
Net of current portion | 60,000 | 60,000 |
Debt discount, net of accretion | (1,014) | (1,304) |
Net of discount and current portion | $ 58,986 | $ 58,696 |
Long-term Debt and Financing _7
Long-term Debt and Financing Arrangements - Long-term Debt - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jul. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 23, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||||
Repayments of long-term debt | $ 36,050 | |||||
Loss on extinguishment of debt | $ 575 | |||||
Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Long-term Debt, Gross | $ 60,000 | $ 60,000 | $ 60,000 | |||
Orbi Med [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Repayments of long-term debt | $ 35,000 | |||||
Debt instrument, end of term payment accrued interest | 1,100 | |||||
Loss on extinguishment of debt | 600 | |||||
Canadian Imperial Bank of Commerce [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate effective percentage | 7.30% | 7.30% | ||||
Average effective interest rate | 7.70% | 7.60% | ||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Long-term Debt, Gross | 60,000 | |||||
Description of covenants | The financial covenants include, among other covenants, (x) a requirement to maintain a minimum liquidity amount of the greater of either (i) the consolidated adjusted EBITDA loss (or gain) for the trailing four month period (only if EBITDA is negative) and (ii) $10.0 million, and (y) a requirement to maintain total net revenue of at least 75% of the level set forth in the total revenue plan presented to CIBC. | |||||
Minimum liquidity covenant amount | $ 10,000 | $ 10,000 | ||||
Minimum percentage to maintain total net revenue set forth in total revenue plan presented | 75% | |||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Term Loan [Member] | In Event Of Default [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Increasing applicable margin | 2% | |||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Upfront Fees and Other Costs [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument discount gross | $ 1,500 | |||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
LIBOR rate | 1% | |||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Before March 1, 2028 [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee percentage | 2% | |||||
Canadian Imperial Bank of Commerce [Member] | Credit Agreement [Member] | Calendar Quarter Ending on September 30, 2023 but Before March 1, 2028 [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee percentage | 1% | |||||
Canadian Imperial Bank of Commerce [Member] | Maximum [Member] | Credit Agreement [Member] | Individual Acquisition [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Credit Agreement Acquisition Cash Consideration | $ 50,000 | |||||
Canadian Imperial Bank of Commerce [Member] | Maximum [Member] | Credit Agreement [Member] | Aggregate All Acquisitions [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Credit Agreement Acquisition Cash Consideration | $ 150,000 | |||||
Canadian Imperial Bank of Commerce [Member] | Term Secured Overnight Financing Rate [Member] | Credit Agreement [Member] | Interest Rate Option One [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Basis spread on variable rate | 2% | |||||
Canadian Imperial Bank of Commerce [Member] | Term Secured Overnight Financing Rate [Member] | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option One [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
LIBOR rate | 1.50% | |||||
Canadian Imperial Bank of Commerce [Member] | Prime Rate | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Basis spread on variable rate | 4% | |||||
Canadian Imperial Bank of Commerce [Member] | Amount Over Federal Funds Effective Rate [Member] | Minimum [Member] | Credit Agreement [Member] | Interest Rate Option Two | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Basis spread on variable rate | 0.50% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||||||
May 25, 2023 | Apr. 15, 2019 | Sep. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Aug. 31, 2021 | |
Unrecognized compensation cost related to unvested employee and director stock-based awards | $ 46.2 | $ 46.2 | ||||||
Weighted average period for unrecognized compensation cost | 2 years 6 months | |||||||
Common Stock | ||||||||
Number of shares issued | 11,759 | 14,135 | 17,678 | 12,465 | ||||
2019 Stock Plan [Member] | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 3,428,571 | |||||||
Share based compensation arrangement by share based payment award number of shares available for grant | 1,389,390 | 1,389,390 | ||||||
2019 Stock Plan [Member] | Common Stock | ||||||||
Share-based compensation arrangement by sharebased payment award, number of additional shares authorized | 1,000,000 | |||||||
2019 Stock Plan [Member] | From 2014 Plan [Member] | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 1,595,189 | |||||||
2019 Employee Stock Purchase Plan [Member] | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 371,142 | |||||||
Share based compensation arrangement by share based payment award number of shares available for grant | 264,559 | 264,559 | ||||||
Purchase price of common stock, percent | 85% | |||||||
Number of shares issued | 25,894 | |||||||
2021 Inducement Plan [Member] | Common Stock | ||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 1,000,000 | |||||||
Share based compensation arrangement by share based payment award number of shares available for grant | 290,719 | 290,719 | ||||||
2019 Plan and 2021 Inducement Plan [Member] | Common Stock | ||||||||
Options granted | 473,346 | |||||||
Share-based compensation arrangement by share-based payment award, options, grants in period, weighted average grant date fair value | $ 45.49 | |||||||
2019 Plan and 2021 Inducement Plan [Member] | Restricted stock units [Member] | ||||||||
Shares granted | 251,384 | |||||||
Share-based compensation arrangement by share-based payment award, grants in period, weighted average grant date fair value | $ 70.21 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Allocated Share-based Compensation Expense | $ 5,188 | $ 2,704 | $ 14,067 | $ 7,330 |
Cost of revenue [Member] | ||||
Allocated Share-based Compensation Expense | 112 | 33 | 241 | 89 |
Research, development and clinical trials expenses [Member] | ||||
Allocated Share-based Compensation Expense | 781 | 394 | 2,013 | 1,079 |
Selling, general and administrative expenses [Member] | ||||
Allocated Share-based Compensation Expense | $ 4,295 | $ 2,277 | $ 11,813 | $ 6,162 |
Asset Acquisition - Additional
Asset Acquisition - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Aug. 02, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | |
Asset Acquisition [Line Items] | |||
Acquired in-process research and development expenses | $ 27,212 | $ 27,212 | |
BTL [Member] | |||
Asset Acquisition [Line Items] | |||
Acquisition, date | Aug. 02, 2023 | ||
Acquired in-process research and development expenses | $ 27,200 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 01, 2023 | Jan. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2023 | |
Operating lease, additional amount due over remaining lease term | $ 2.6 | |||||
Defined contribution plan, contribution amount | $ 0.3 | $ 1 | $ 0 | |||
Recorded unconditional purchase commitment, minimum quantity required | $ 9.5 | |||||
Recorded unconditional purchase commitment, maturity year and month | 2029-12 | |||||
Remaining purchase commitment | $ 7 | $ 7 | ||||
First 3% of Compensation Contributed [Member] | ||||||
Defined contribution plan, matching percentage of each employee's contribution | 100% | |||||
100% Match [Member] | ||||||
Defined contribution plan, percentage of matching contribution | 3% | |||||
Fifty Percent Match [Member] | Additional Maximum [Member] | ||||||
Defined contribution plan, percentage of matching contribution | 2% | |||||
Excess of 3% to 5% of Compensation Contributed [Member] | ||||||
Defined contribution plan, matching percentage of each employee's contribution | 50% |
Segment Reporting and Geograp_3
Segment Reporting and Geographic Data - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2023 Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment Reporting and Geograp_4
Segment Reporting and Geographic Data - Geographic Areas Long-lived Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 131,004 | $ 19,223 |
United States [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | 130,214 | 18,568 |
All Other Countries [Member] | |||
Geographic Areas, Long-Lived Assets [Abstract] | |||
Long-lived assets | [1] | $ 790 | $ 655 |
[1] Long-lived assets consist of property, plant and equipment, net of depreciation, which are categorized based on their location of domicile. |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | ||||
Research development and clinical trials expenses | $ 0.4 | $ 0.5 | $ 0.8 | $ 1 |
Payment to customers related to use of aircraft | $ 0.7 | $ 0.7 |
Revenue - Schedule of Net Reven
Revenue - Schedule of Net Revenue by Organ and Country (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | ||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | $ 66,430 | $ 25,683 | $ 160,449 | $ 62,084 | |
OCS transplant revenue | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 63,993 | 25,683 | 158,012 | 62,084 |
OCS transplant revenue | United States [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 59,693 | 23,285 | 146,141 | 54,984 |
OCS transplant revenue | All Other Countries [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 4,300 | 2,398 | 11,871 | 7,100 |
Lung revenue [Member] | OCS transplant revenue | United States [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 3,410 | 1,438 | 7,658 | 6,033 |
Lung revenue [Member] | OCS transplant revenue | All Other Countries [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 310 | 161 | 964 | 703 |
Heart revenue [Member] | OCS transplant revenue | United States [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 15,069 | 9,304 | 41,481 | 18,921 |
Heart revenue [Member] | OCS transplant revenue | All Other Countries [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 3,893 | 2,237 | 10,803 | 6,397 |
Liver revenue [Member] | OCS transplant revenue | United States [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | 41,214 | $ 12,543 | 97,002 | $ 30,030 |
Liver revenue [Member] | OCS transplant revenue | All Other Countries [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Total OCS transplant revenue | [1],[2] | $ 97 | $ 104 | ||
[1] Revenue by country is categorized based on the location of the end customer. Total revenue includes product and service revenue. Service revenue unrelated to OCS transplant, which was $ 2.4 million for each of the three and nine months ended September 30, 2023 and none for the three and nine months ended September 30, 2022, is not included in this table. |
Revenue - Revenue - Schedule of
Revenue - Revenue - Schedule of Net Revenue by Organ and Country (Parenthetical) (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 66,430,000 | $ 25,683,000 | $ 160,449,000 | $ 62,084,000 |
Unrelated to OCS Transplant [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 2,400,000 | $ 0 | $ 2,400,000 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Director [Member] | ||||
Related Party Transaction [Line Items] | ||||
Compensation expense | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.3 |