Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-39430 | |
Entity Registrant Name | ACUTUS MEDICAL, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 45-1306615 | |
Entity Address, Address Line One | 2210 Faraday Ave. | |
Entity Address, Address Line Two | Suite 100, | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92008 | |
City Area Code | 442 | |
Local Phone Number | 232-6080 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | AFIB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,303,779 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001522860 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 24,100 | $ 25,584 |
Marketable securities, short-term | 14,375 | 44,863 |
Restricted cash, short-term | 7,015 | 5,764 |
Accounts receivable | 8,952 | 21,085 |
Inventory | 15,728 | 13,327 |
Employer retention credit receivable | 0 | 4,703 |
Prepaid expenses and other current assets | 2,467 | 2,541 |
Total current assets | 72,637 | 117,867 |
Noncurrent assets | ||
Property and equipment, net | 6,611 | 9,221 |
Right-of-use assets, net | 3,359 | 3,872 |
Intangible assets, net | 1,433 | 1,583 |
Other assets | 688 | 897 |
Total assets | 84,728 | 133,440 |
Current liabilities: | ||
Accounts payable | 4,754 | 4,721 |
Accrued liabilities | 7,438 | 9,686 |
Contingent consideration, short-term | 0 | 1,800 |
Operating lease liabilities, short-term | 707 | 319 |
Warrant liability | 1,868 | 3,346 |
Total current liabilities | 14,767 | 19,872 |
Operating lease liabilities, long-term | 3,462 | 4,103 |
Long-term debt | 34,761 | 34,434 |
Other long-term liabilities | 32 | 12 |
Total liabilities | 53,022 | 58,421 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 6,666 shares of the preferred stock, designated as Series A Common Equivalent Preferred Stock, are issued and outstanding as of September 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value; 260,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 29,289,934 and 28,554,656 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 29 | 29 |
Additional paid-in capital | 598,842 | 594,173 |
Accumulated deficit | (566,212) | (518,314) |
Accumulated other comprehensive loss | (953) | (869) |
Total stockholders' equity | 31,706 | 75,019 |
Total liabilities and stockholders' equity | $ 84,728 | $ 133,440 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 6,666 | 6,666 |
Preferred stock, shares outstanding (in shares) | 6,666 | 6,666 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 260,000,000 | 260,000,000 |
Common stock, shares issued (in shares) | 29,289,934 | 28,554,656 |
Common stock, shares outstanding (in shares) | 29,289,934 | 28,554,656 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and 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] | ||||
Revenue | $ 5,238 | $ 3,644 | $ 14,696 | $ 11,401 |
Cost of products sold | 8,595 | 6,951 | 23,447 | 23,589 |
Gross profit | (3,357) | (3,307) | (8,751) | (12,188) |
Operating expenses (income): | ||||
Research and development | 4,795 | 5,946 | 17,712 | 21,884 |
Selling, general and administrative | 7,432 | 9,679 | 26,280 | 38,207 |
Goodwill impairment | 0 | 0 | 0 | 12,026 |
Restructuring | 0 | 1,331 | 475 | 2,280 |
Change in fair value of contingent consideration | 0 | 198 | 123 | 1,153 |
Gain on sale of business | (2,648) | 0 | (5,927) | (43,575) |
Total operating expenses | 9,579 | 17,154 | 38,663 | 31,975 |
Loss from operations | (12,936) | (20,461) | (47,414) | (44,163) |
Other income (expense): | ||||
Loss on debt extinguishment | 0 | 0 | 0 | (7,947) |
Change in fair value of warrant liability | 636 | 904 | 1,478 | 904 |
Interest income | 547 | 241 | 2,223 | 292 |
Interest expense | (1,409) | (1,109) | (4,110) | (3,810) |
Total other income (expense), net | (226) | 36 | (409) | (10,561) |
Loss before income taxes | (13,162) | (20,425) | (47,823) | (54,724) |
Income tax expense | 75 | 0 | 75 | 0 |
Net loss | (13,237) | (20,425) | (47,898) | (54,724) |
Other comprehensive income (loss) | ||||
Unrealized gain on marketable securities | 4 | 39 | 7 | 0 |
Foreign currency translation adjustment | (66) | (351) | (91) | (904) |
Comprehensive loss | $ (13,299) | $ (20,737) | $ (47,982) | $ (55,628) |
Net loss per common share, basic (in dollars per share) | $ (0.45) | $ (0.72) | $ (1.65) | $ (1.93) |
Net loss per common share, diluted (in dollars per share) | $ (0.45) | $ (0.72) | $ (1.65) | $ (1.93) |
Weighted average shares outstanding, basic (in shares) | 29,262,768 | 28,359,516 | 29,024,353 | 28,273,207 |
Weighted average shares outstanding, diluted (in shares) | 29,262,768 | 28,359,516 | 29,024,353 | 28,273,207 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Preferred stock, beginning balance (in shares) at Dec. 31, 2021 | 6,666 | |||||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | 27,957,223 | |||||
Balance at beginning of period at Dec. 31, 2021 | $ 105,726 | $ 28 | $ 584,613 | $ (478,698) | $ (217) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized gain on marketable securities | 0 | |||||
Foreign currency translation adjustment | (904) | (904) | ||||
Stock option exercises (in shares) | 98,772 | |||||
Stock option exercises | 66 | 66 | ||||
Stock-based compensation (in shares) | 223,567 | |||||
Stock-based compensation | 7,435 | 7,435 | ||||
Employee stock purchase plan shares issued (in shares) | 94,226 | |||||
Employee stock purchase plan shares issued | 182 | 182 | ||||
Net loss | (54,724) | (54,724) | ||||
Preferred stock, ending balance (in shares) at Sep. 30, 2022 | 6,666 | |||||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 28,373,788 | |||||
Balance at end of period at Sep. 30, 2022 | 57,781 | $ 28 | 592,296 | (533,422) | (1,121) | |
Preferred stock, beginning balance (in shares) at Jun. 30, 2022 | 6,666 | |||||
Common stock, beginning balance (in shares) at Jun. 30, 2022 | 28,349,200 | |||||
Balance at beginning of period at Jun. 30, 2022 | 76,651 | $ 28 | 590,429 | (512,997) | (809) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized gain on marketable securities | 39 | 39 | ||||
Foreign currency translation adjustment | (351) | (351) | ||||
Stock-based compensation (in shares) | 24,588 | |||||
Stock-based compensation | 1,867 | 1,867 | ||||
Net loss | (20,425) | (20,425) | ||||
Preferred stock, ending balance (in shares) at Sep. 30, 2022 | 6,666 | |||||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 28,373,788 | |||||
Balance at end of period at Sep. 30, 2022 | $ 57,781 | $ 28 | 592,296 | (533,422) | (1,121) | |
Preferred stock, beginning balance (in shares) at Dec. 31, 2022 | 6,666 | 6,666 | ||||
Common stock, beginning balance (in shares) at Dec. 31, 2022 | 28,554,656 | 28,554,656 | ||||
Balance at beginning of period at Dec. 31, 2022 | $ 75,019 | $ 29 | 594,173 | (518,314) | (869) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized gain on marketable securities | 7 | 7 | ||||
Foreign currency translation adjustment | $ (91) | (91) | ||||
Stock option exercises (in shares) | 3,218 | 3,218 | ||||
Stock option exercises | $ 4 | 4 | ||||
Stock-based compensation (in shares) | 686,898 | |||||
Stock-based compensation | 4,640 | 4,640 | ||||
Employee stock purchase plan shares issued (in shares) | 45,162 | |||||
Employee stock purchase plan shares issued | 25 | 25 | ||||
Net loss | $ (47,898) | (47,898) | ||||
Preferred stock, ending balance (in shares) at Sep. 30, 2023 | 6,666 | 6,666 | ||||
Common stock, ending balance (in shares) at Sep. 30, 2023 | 29,289,934 | 29,289,934 | ||||
Balance at end of period at Sep. 30, 2023 | $ 31,706 | $ 29 | 598,842 | (566,212) | (953) | |
Preferred stock, beginning balance (in shares) at Jun. 30, 2023 | 6,666 | |||||
Common stock, beginning balance (in shares) at Jun. 30, 2023 | 29,206,570 | |||||
Balance at beginning of period at Jun. 30, 2023 | 43,741 | $ 29 | 597,578 | (552,975) | (891) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized gain on marketable securities | 4 | 4 | ||||
Foreign currency translation adjustment | (66) | (66) | ||||
Stock-based compensation (in shares) | 83,364 | |||||
Stock-based compensation | 1,264 | 1,264 | ||||
Net loss | $ (13,237) | (13,237) | ||||
Preferred stock, ending balance (in shares) at Sep. 30, 2023 | 6,666 | 6,666 | ||||
Common stock, ending balance (in shares) at Sep. 30, 2023 | 29,289,934 | 29,289,934 | ||||
Balance at end of period at Sep. 30, 2023 | $ 31,706 | $ 29 | $ 598,842 | $ (566,212) | $ (953) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (47,898) | $ (54,724) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 3,498 | 4,653 |
AcQMap Systems converted to sales | 238 | 266 |
Sales-type lease gain | (310) | (87) |
Amortization of intangible assets | 150 | 370 |
Non-cash stock-based compensation expense | 4,915 | 7,497 |
(Accretion of discounts) amortization of premiums on marketable securities, net | (1,318) | 237 |
Amortization of debt issuance costs | 325 | 741 |
Amortization of operating lease right-of-use assets | 513 | 480 |
Loss on debt extinguishment | 0 | 7,947 |
Goodwill impairment | 0 | 12,026 |
Gain on sale of business, net | (5,927) | (43,575) |
Direct costs paid related to sale of business | 0 | (2,917) |
Change in fair value of warrant liability | (1,478) | (904) |
Loss on disposal of property and equipment | 268 | 0 |
Change in fair value of contingent consideration | 123 | 1,153 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,244 | 420 |
Inventory | (2,401) | 1,812 |
Employer retention credit receivable | 4,703 | 0 |
Prepaid expenses and other current assets | 420 | (4,296) |
Other assets | 495 | 386 |
Accounts payable | (2) | (2,929) |
Accrued liabilities | (2,430) | (179) |
Operating lease liabilities | (253) | (390) |
Other long-term liabilities | 20 | (40) |
Net cash used in operating activities | (45,105) | (72,053) |
Cash flows from investing activities | ||
Proceeds from sale of business | 17,000 | 50,000 |
Purchases of available-for-sale marketable securities | (38,521) | (33,235) |
Sales of available-for-sale marketable securities | 0 | 18,599 |
Maturities of available-for-sale marketable securities | 70,250 | 59,642 |
Purchases of property and equipment | (1,394) | (2,473) |
Net cash provided by investing activities | 47,335 | 92,533 |
Cash flows from financing activities | ||
Repayment of debt | 0 | (44,550) |
Penalty fees paid for early prepayment of debt | 0 | (1,063) |
Borrowing under new debt, net of fees | 0 | 34,825 |
Payment of debt issuance costs | 0 | (626) |
Proceeds from the exercise of stock options | 4 | 66 |
Repurchase of common shares to pay employee withholding taxes | (275) | (62) |
Proceeds from employee stock purchase plan | 25 | 182 |
Payment of contingent consideration | (1,923) | (873) |
Net cash used in financing activities | (2,169) | (12,101) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (294) | (447) |
Net change in cash, cash equivalents and restricted cash | (233) | 7,932 |
Cash, cash equivalents and restricted cash, at the beginning of the period | 31,348 | 24,221 |
Cash, cash equivalents and restricted cash, at the end of the period | 31,115 | 32,153 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 3,731 | 3,101 |
Supplemental disclosure of noncash investing and financing activities: | ||
Accounts receivable from sale of business | 6,111 | 0 |
Change in unrealized (gain) loss on marketable securities | (7) | 0 |
Change in unpaid purchases of property and equipment | 35 | 48 |
Contingent consideration escrow release | 0 | 380 |
Net book value on AcQMap system sales-type leases | 238 | 244 |
Amount of debt proceeds allocated to warrant liability | $ 0 | $ 3,379 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Acutus Medical, Inc. (the “Company”) historically designed, manufactured and marketed a range of tools for catheter-based ablation procedures to treat various arrhythmias. Prior to November 2023, the Company’s product portfolio included novel access sheaths, diagnostic and mapping catheters, ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs. In November 2023, the Company’s Board of Directors approved a strategic realignment of resources and corporate restructuring (the “Restructuring”). The Company began implementation of a shift in its business model to solely support the manufacturing and distribution of Medtronic Inc.’s (“Medtronic”) left-heart access product portfolio, including to potentially earn earnout payments from Medtronic pursuant to its manufacturing and distribution arrangements with Medtronic. As part of the Restructuring, the Company will wind down its mapping and ablation businesses and will no longer manufacture or distribute the AcQMap Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate Force-Sensing Ablation Catheter, the AcQGuide Max 2.0 steerable sheath, and associated accessories, and will explore strategic alternatives for these businesses (including a potential sale of related assets). The Company expects that the Restructuring will be substantially complete in the first quarter of 2024. See Note 19 – Subsequent Events – Strategic Realignment of Resources and Corporate Restructuring , below, for further details. The Company was incorporated in the state of Delaware on March 25, 2011, and is located in Carlsbad, California. Liquidity, Capital Resources and Going Concern The Company has limited revenue, and has incurred significant operating losses and negative cash flows from operations since its inception, and anticipates that it will incur significant losses for at least the next several years. As of September 30, 2023 and December 31, 2022, the Company had cash, cash equivalents, restricted cash and marketable securities of $45.5 million and $76.2 million, respectively. For the nine m onths ended September 30, 2023 and 2022, net losses were $47.9 million and $54.7 million, respectively, and n et cash used in operating activities was $45.1 million and $72.1 million, respectively. As of September 30, 2023 and December 31, 2022, the Company had an accumulated deficit of $566.2 million and $518.3 million, respectively, and working capital of $57.9 million and $98.0 million, respectively. The Restructuring is intended to reduce the Company’s operating expenses and optimize its cash resources by focusing exclusively on the manufacturing and distribution of the left-heart access Products (as defined in Note 3 – Sale of Business , below) to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments. Following the Restructuring, the Company expects its primary uses of capital to be investments in manufacturing and distributing the left-heart access Products to Medtronic and related expenses, raw materials and supplies, legal and other regulatory expenses, general administrative costs and working capital. On June 30, 2022, Medtronic paid the Company $50.0 million at the first closing (the "First Closing") of the sale of the Company's left-heart access portfolio to Medtronic, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing to secure the Company's indemnification obligations under the asset purchase agreement ("Asset Purchase Agreement") entered into with Medtronic on April 26, 2022. The OEM Earnout (as defined in Note 3 - Sale of Business , below) under the Asset Purchase Agreement with Medtronic was achieved on October 31, 2022, with $20.0 million paid by Medtronic to the Company in November 2022. Additionally, the Transfer Earnout (as defined in Note 3 - Sale of Business , below) under the Asset Purchase Agreement with Medtronic was achieved on December 21, 2022, with $17.0 million paid by Medtronic to the Company in January 2023. Beginning in February 2023, following Medtronic's first commercial sale of the left-heart access Products after the Company's achievement of the OEM Earnout (as defined in Note 3 - Sale of Business , below), the Company became eligible to earn amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the left-heart access products achieved by Medtronic each year over four years. During the nine months ended September 30, 2023, the Company earned $6.1 million in contingent consideration based on Medtronic's left-heart access Products sales. As part of the Restructuring, the Company will focus exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments. Management believes the Company’s current cash, cash equivalents and marketable securities are sufficient to fund operations for at least the next 12 months from the date of this filing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and note disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. Principles of Consolidation The condensed consolidated financial statements include the accounts of Acutus Medical, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates and Assumptions The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and disclosures of contingent assets and liabilities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment and reportable segment. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts, the balances of which, at times and as of September 30, 2023 and December 31, 2022, exceeded federally insured limits. Restricted cash consists of (i) deposited cash collateral for the Company’s corporate credit card program and (ii) cash received for the sale of business to Medtronic held in an indemnity escrow account until certain terms of sale are met. The following table reconciles cash, cash equivalents and restricted cash in the condensed consolidated balance sheets to the total balances as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Cash and cash equivalents $ 24,100 $ 25,584 Restricted cash 7,015 5,764 Total cash, cash equivalents and restricted cash $ 31,115 $ 31,348 Marketable Securities The Company’s marketable securities portfolio consists of investments in money market funds, commercial paper, U.S. treasury securities, Yankee debt securities, and asset-backed securities. The Company considers its debt securities to be available-for-sale securities. Available-for-sale securities are classified as cash equivalents or short-term or long-term marketable securities based on the maturity date at time of purchase and their availability to meet current operating requirements. Marketable securities that mature in three months or less from the date of purchase are classified as cash equivalents. Marketable securities, excluding cash equivalents, that mature in one year or less are classified as short-term available-for-sale securities and are reported as a component of current assets. Securities that are classified as available-for-sale are measured at fair value with temporary unrealized gains and losses reported in other comprehensive income (loss), and as a component of stockholders’ equity until their disposition or maturity. See Fair Value Measurements, below. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s current intent and ability to sell the security if it is required to do so. Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific-identification method. Marketable securities are subject to a periodic impairment review. The Company may recognize an impairment charge when a decline in the fair value of investments below the cost basis is determined to be other-than-temporary. In determining whether a decline in market value is other-than-temporary, various factors are considered, including the cause, duration of time and severity of the impairment, any adverse changes in the investee’s financial condition and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. Declines in value judged to be other-than-temporary are included in the Company’s condensed consolidated statements of operations and comprehensive loss. The Company did not record any other-than-temporary impairments related to marketable securities in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents, restricted cash, accounts receivable and marketable securities. The Company has not experienced losses on these accounts, and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. Revenue from Contracts with Customers The Company accounts for revenue earned from contracts with customers under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers (“ASC 606”), and ASC 842, Leases ("ASC 842"). The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer. • Step 2: Identify the performance obligations in the contract. • Step 3: Determine the transaction price. • Step 4: Allocate the transaction price to the performance obligations in the contract. • Step 5: Recognize revenue when, or as, the company satisfies a performance obligation. ASC 842 provides guidance on determining whether an agreement contains a lease. ASC 842 defines a lease as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period of time in exchange for consideration. For new customers, the Company places its medical diagnostic equipment, the AcQMap System, at customer sites under evaluation agreements and generates revenue from the sale of disposable products used with the AcQMap System. Disposable products primarily include AcQMap Catheters and AcQGuide Steerable Sheaths. Outside of the United States, the Company also has the Qubic Force Device which generates revenue from the sale of the AcQBlate Force Ablation Catheters. The Company provides the disposable products in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposables at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment has been provided to the customer for free with no binding agreement or requirement to purchase any disposable products. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation. Additionally, the Company sells the AcQMap System to customers along with software updates on a when-and-if-available basis, as well as the Qubic Force Device and a transseptal crossing line of products which can be used in a variety of heart procedures and does not need to be accompanied with an AcQMap System or Qubic Force Device. Included in the transseptal crossing line of products are primarily the AcQRef Introducer Sheath, the AcQGuide Sheaths and the AcQCross Transseptal Dilator/Needle. The Company also enters into deferred equipment agreements that are generally structured such that the Company agrees to provide an AcQMap System at no up-front charge, with title of the device transferring to the customer at the end of the contract term, in exchange for the customer’s commitment to purchase disposables at a specified price over the term of the agreement, which generally ranges from two Lastly, the Company enters into short-term operating leases for the rental of the AcQMap System after an evaluation. These lease agreements impose no requirement on the customer to purchase the equipment, and the equipment is not transferred to the customer at the end of the lease term. The short-term nature of the lease agreements does not result in lease payments accumulating to an amount that equals the value of the equipment nor is the lease term reflective of the economic life of the equipment. The Company’s contracts primarily include fixed consideration. Generally, there are no discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 to 60 days. The delivery of disposable products are performance obligations satisfied at a point in time. The disposable products are shipped Free on Board (“FOB”) shipping point or FOB destination. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, at which point the customer obtains control and thus revenue is recognized at that point in time. Revenue is recognized on delivery for disposable products shipped FOB destination. For direct customers, the installation and delivery of the AcQMap System is satisfied at a point in time when the installation is complete, which is when the customer can benefit and has control of the system. For AcQMap System sold to Biotronik SE & Co. KG (“Biotronik”), the installation is not a performance obligation as it is performed by Biotronik, and therefore the AcQMap System is satisfied at a point in time when they have control of the system. The Company’s software updates and equipment service performance obligations are satisfied evenly over time as the customer simultaneously receives and consumes the benefits of the Company’s performance for these services throughout the service period. The Company allocates the transaction price to each performance obligation identified in the contract based on the relative standalone selling price (“SSP”). The Company determines SSP for the purposes of allocating the transaction price to each performance obligation based on the adjusted market assessment approach that maximizes the use of observable inputs, which include, but are not limited to, sales transactions where the specific performance obligations are sold separately, Company list prices and specific offers to customers. Except for the deferred equipment agreements noted above, the Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative ("SG&A") expense as incurred due to the short duration of the Company’s contracts. The Company’s contract balances consisted solely of accounts receivable as of September 30, 2023 and December 31, 2022. In May 2020, the Company entered into bi-lateral distribution agreements (the “Bi-Lateral Distribution Agreements”) with Biotronik. Pursuant to the Bi-Lateral Distribution Agreements, the Company obtained a non-exclusive license to distribute a range of Biotronik’s products and accessories in the United States, Canada, China, Hong Kong and multiple Western European countries under the Company’s private label. Moreover, if an investigational device exemption (“IDE”) clinical trial is required for these products to obtain regulatory approval in the United States, or a clinical trial is required for these products to obtain regulatory approval in China, the Company will obtain an exclusive distribution right in such territories for a term of up to five years commencing on the date of regulatory approval if the Company covers the cost of the IDE or other clinical trial and the Company conducts such study within a specified period. Biotronik also agreed to distribute the Company’s products and accessories in Germany, Japan, Mexico, Switzerland and multiple countries in Asia-Pacific, Eastern Europe, the Middle East and South America. The Company also granted Biotronik a co-exclusive right to distribute these products in Hong Kong. Each party will pay to the other party a specified transfer price on the sale of the other party’s products and, accordingly, will earn a distribution margin on the sale of the other party’s products. The foregoing description applies to products that will no longer be manufactured and sold by the Company upon completion of the Restructuring. See Note 1 – Organization and Description of Business – Liquidity, Capital Resources and Going Concern , above. In 2022, the Company sold its left-heart access transseptal crossing business to Medtronic. In connection with the sale, the Company entered into a distribution agreement (the "Distribution Agreement") with Medtronic, pursuant to which the Company acts as the original equipment manufacturer ("OEM") supplier of these products. The Company will produce and sell the products to Medtronic for a period of up to four years. Revenue is recognized when the title to the products are transferred to Medtronic, which occurs when the products are shipped from our facility (or FOB shipping point). See Note 3 – Sale of Business , below, for further details. As part of the Restructuring, the Company will focus exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments. The following table sets forth the Company’s revenue for disposables, systems and service/other for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Disposables $ 4,069 $ 2,857 $ 11,409 $ 9,402 Systems 563 476 1,254 823 Service/Other 606 311 2,033 1,176 Total revenue $ 5,238 $ 3,644 $ 14,696 $ 11,401 The following table provides revenue by geographic location for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) United States $ 3,347 $ 1,925 $ 8,720 $ 5,985 Outside the United States 1,891 1,719 5,976 5,416 Total revenue $ 5,238 $ 3,644 $ 14,696 $ 11,401 Inventory Inventory is stated at the lower of cost (first-in, first-out basis) or net realizable value. The Company recorded write-downs for excess and obsolete inventory of $0.3 million and $0.2 million for the three months ended September 30, 2023 and 2022, respectively, and $0.9 million and $2.6 million for the nine months ended September 30, 2023 and 2022, respectively, based on management’s review of inventories on hand, comparisons to estimated future usage and sales, observed shelf-life and assumptions about the likelihood of obsolescence. Accounts Receivable Trade accounts receivable are recorded net of allowances for uncollectible accounts. The Company evaluates the collectability of its accounts receivable based on various factors including historical experience, the length of time the receivables are past due and the financial health of the customer. The Company reserves specific receivables if collectability is no longer reasonably assured. Based upon the assessment of these factors, the Company did not record an allowance for uncollectible accounts as of September 30, 2023 or December 31, 2022. Pursuant to the Asset Purchase Agreement with Medtronic, the Company was eligible to receive the Transfer Earnout, a contingent cash consideration of $17.0 million upon the Company’s initial submission for CE Mark certification. The Company met this condition as of December 31, 2022 and recorded a receivable on the consolidated balance sheets for the year then ended. Medtronic provided full payment in January 2023. See Note 3 - Sale of Business for additional details. In addition, beginning in February 2023, following Medtronic's first commercial sale of the left-heart access Products after the Company's achievement of the OEM Earnout (as such terms are defined in Note 3 - Sale of Business , below), the Company became eligible to earn amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the left-heart access Products achieved by Medtronic each year over four years. During the nine months ended September 30, 2023, the Company earned $6.1 million based on Medtronic's left-heart access Products sales and recorded a corresponding receivable on the condensed consolidated balance sheets as of the period then ended. Accounts receivable recorded on the condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022 consists of the following (in thousands): September 30, December 31, (unaudited) Trade accounts receivable $ 2,841 $ 4,085 Earnouts receivable from Medtronic 6,111 17,000 Total accounts receivable $ 8,952 $ 21,085 Employee Retention Credit Receivable The Employee Retention Credit is a refundable U.S. tax credit separate from tax based on income for businesses that continued to pay employees while shut down due to the COVID-19 pandemic or had significant declines in gross receipts from March 13, 2020 to December 31, 2021. The Company applied for the tax credit in 2022 and as of September 30, 2023, the entire $6.8 million claimed tax credit has been refunded to the Company, of which $4.7 million was received during the nine months ended September 30, 2023. Property and Equipment, Net Property and equipment are recorded at cost. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets, generally three Intangible Assets The Company’s intangible assets consist of a license agreement with Biotronik. The Company determines the appropriate useful life of its finite-lived intangible assets by performing an analysis of expected cash flows of the acquired assets. Finite-lived intangible assets are amortized over their estimated useful lives using the straight-line method, which approximates the pattern in which the economic benefits are consumed. Acquired in-process technology is classified as a finite-lived intangible and amortized accordingly. Indefinite-lived intangible assets are tested for impairment at least annually and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Indefinite-lived intangible assets are impaired if their estimated fair values are less than their carrying value. Goodwill Goodwill represents the excess of the purchase price of an entity over the estimated fair value of the assets acquired and liabilities assumed, and it is presented as goodwill in the accompanying condensed consolidated balance sheets. Under ASC 350, Intangibles – Goodwill and Other (“ASC 350”), goodwill is not amortized but is subject to periodic impairment testing. ASC 350 requires that an entity assign its goodwill to reporting units and test each reporting unit’s goodwill for impairment at least on an annual basis and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. In the evaluation of goodwill for impairment, which is performed annually during the fourth quarter, the Company first assesses qualitative factors to determine whether the existence of events or circumstances led to a determination that it was more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, the Company is required to perform the quantitative goodwill impairment test. The Company has one reporting unit. During the nine months ended September 30, 2022, the Company fully impaired its goodwill balance of $12.0 million. Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment and finite-lived intangible assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss is recognized when the asset’s carrying value exceeds the total undiscounted cash flows expected from its use and eventual disposition. The amount of the impairment loss is determined as the excess of the carrying value of the asset over its fair value. For the three and nine months ended September 30, 2023 and 2022, the Company determined that there was no impairment of property and equipment or intangible assets. Foreign Currency Translation and Transactions The assets, liabilities and results of operations of Acutus Medical N.V. and Acutus Medical UK Limited are measured using their functional currency, the Euro and British Pound Sterling, respectively, which is the currency of the primary foreign economic environment in which the subsidiaries operate. Upon consolidating these entities with the Company, their assets and liabilities are translated to U.S. dollars at currency exchange rates as of the balance sheet date and their revenues and expenses are translated at the weighted average currency exchange rates during the applicable reporting periods. Translation adjustments resulting from the process of translating the entities’ financial statements are reported in accumulated other comprehensive loss in the condensed consolidated balance sheets and foreign currency translation adjustment in the condensed consolidated statements of operations and comprehensive loss. Lease Property The Company leases office space in Carlsbad, California as its corporate headquarters and for manufacturing operations. Additionally, it leases office space in Zaventem, Belgium for international operations. The Company accounts for its lease property under ASC 842. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases, and are recorded on the condensed consolidated balance sheets as both a right-of-use asset and a lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate, which is the rate for collateralized borrowings based on the current economic environment, credit history, credit rating, value of leases, currency in which the lease obligation is satisfied, rate sensitivity, lease term and materiality . Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset results in straight-line rent expense over the lease term. Variable lease expenses are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elected to combine lease and non-lease components. The Company adopted the policy election to exclude short-term leases having initial terms of twelve months from the initial recognition provisions of ASC 842. See Note 11 - Operating Leases for additional details. Cost of Products Sold Cost of products sold includes raw materials, direct labor, manufacturing overhead, shipping and receiving costs and other less significant indirect costs related to the production of the Company’s products. Research and Development Prior to the Restructuring, the Company was actively engaged in new product research and development efforts. Research and development expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel directly engaged in research and development activities, clinical trial expenses, equipment costs, material costs, allocated rent and facilities costs and depreciation. Research and development expenses relating to possible future products are expensed as incurred. The Company also accrues and expenses costs for activities associated with clinical trials performed by third parties as incurred. All other costs relative to setting up clinical trial sites are expensed as incurred. Clinical trial site costs related to patient enrollment are accrued as patients are entered into the trials. Selling, General and Administrative Selling, general, and administrative expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel in sales, executive, finance and other administrative functions, allocated rent and facilities costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, marketing costs and insurance costs. Fair Value Measurements Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy is used in determining the inputs for measuring fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3—Unobservable inputs which are supported by little or no market activity and consist of financial instruments valued using pricing models, discounted cash flow methodologies or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. There were no transfers made among the three levels in the fair value hierarchy for the three and nine months ended September 30, 2023 and 2022. As of September 30, 2023 and December 31, 2022, the Company’s cash (excluding cash equivalents which are recorded at fair value on a recurring basis), restricted cash, accounts receivable, accounts payable and accrued expenses were carried at cost, which approximates the fair values due to the short-term nature of each instrument. The carrying amount of the Company’s long-term debt approximates fair value due to its variable market interest rate and management’s opinion that current rates and terms that would be available to the Company with the same maturity and security structure would be essentially equivalent to that of the Company’s long-term debt. The following tables classify the Company’s financial assets and liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurements as of September 30, 2023 (unaudited) Quoted Significant Significant Total Assets included in: Cash and cash equivalents Money market securities $ 21,019 $ — $ — $ 21,019 Marketable securities at fair value U.S. treasury securities — 2,968 — 2,968 Commercial paper — 10,665 — 10,665 Asset-backed securities — 742 — 742 Total fair value $ 21,019 $ 14,375 $ — $ 35,394 Liabilities included in: Warrant liability $ — $ — $ 1,868 $ 1,868 Total fair value $ — $ — $ 1,868 $ 1,868 Fair Value Measurements as of December 31, 2022 Quoted Significant Significant Total Assets included in: Cash and cash equivalents Money market securities $ 22,700 $ — $ — $ 22,700 Marketable securities at fair value U.S. treasury securities — 26,897 — 26,897 Commercial paper — 14,764 — 14,764 Yankee debt securities — 3,202 — 3,202 Total fair value $ 22,700 $ 44,863 $ — $ 67,563 Liabilities included in: Warrant liability $ — $ — $ 3,346 $ 3,346 Contingent consideration — — 1,800 1,800 Total fair value $ — $ — $ 5,146 $ 5,146 The fair value of the Company’s money market securities is determined using quoted market prices in active markets for identical assets. The fair value for the available-for-sale marketable securities is determined based on valuation models using inputs that are observable either directly or indirectly (Level 2 inputs) such as quoted prices for similar assets, yield curve, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments, broker and dealer quotes, as well as other relevant economic measures. Financial Obligations The following table presents changes in Level 3 liabilities measured at fair value for the nine months ended September 30, 2023 (in thousands): Contingent Warrant Liability Balance, December 31, 2022 $ 1,800 $ 3,346 Change in fair value 123 (1,478) Final payment of contingent consideration $ (1,923) $ — Balance, September 30, 2023 (unaudited) $ — $ 1,868 As of September 30, 2023, the fair value of the common stock warrants was estimated using the Black-Scholes option pricing model. The fair value was estimated to be $0.4942 per warrant as of September 30, 2023 and the significant inputs used in the estimation of the fair value were as follows: September 30, 2023 (unaudited) Risk-free interest rate 4.61% Expected term in years 6.75 Expected volatility 85.0% Stock-Based Compensation The Company accounts for all stock-based payments to employees and non-employees, including grants of stock options, restricted stock units ("RSUs"), and restricted stock awards ("RSAs"), to be recognized in the consolidated financial statements based on their respective grant date fair values. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The RSUs and RSAs are valued based on the fair value of the Company’s common stock on the date of grant. The Company expenses stock-based compensation related to stock options, RSUs and RSAs over the requisite service period. All stock-based compensation costs are recorded in cost of pr |
Sale of Business
Sale of Business | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Sale of Business | Sale of Business On June 30, 2022, the Company completed the First Closing in accordance with the Asset Purchase Agreement with Medtronic, pursuant to which the Company agreed to sell to Medtronic certain transseptal access and sheath assets which make up the Company's left-heart access portfolio (and which comprised the Rhythm Xience, Inc. ("Rhythm Xience") product line acquired as part of the Rhythm Xience acquisition). The assets transferred to Medtronic upon the First Closing (the “Assets”) include patents, trademarks, patent and trademark applications, know-how, copyrights, prototypes and other intellectual property owned or licensed by the Company, business records and documents (including regulatory and clinical materials) and manufacturing equipment related to the AcQCross® line of sheath-compatible septal crossing devices, AcQGuide® MINI integrated crossing device and sheath, AcQGuide® FLEX Steerable Introducer with integrated transseptal dilator and needle, and AcQGuide® VUE steerable sheaths (the “Products”). Pursuant to the Asset Purchase Agreement, Medtronic paid $50.0 million at the First Closing, of which $4.0 million was paid into an indemnity escrow account for a period of 18 months following the First Closing to secure indemnification obligations of the Company under the Asset Purchase Agreement, which the Company has recorded as restricted cash on its condensed consolidated balance sheets. The Company is also eligible to receive the following contingent cash consideration pursuant to the Asset Purchase Agreement: (i) $20.0 million upon the Company’s completion, to the reasonable satisfaction of Medtronic, of certain conditions set forth in the Asset Purchase Agreement relating to the Company becoming a qualified supplier of Medtronic for the Products, including demonstration of ISO 14971:2019 compliance, completion of certain test method validations and compliance with certain other reporting requirements (the “OEM Earnout”); (ii) $17.0 million upon the earlier of (A) the Second Closing (as defined below) or (B) the Company’s initial submission for CE Mark certification of the Products under the European Union Medical Devices Regulation, to the reasonable satisfaction of a third-party regulatory consultant, subject to certain other conditions as set forth in the Asset Purchase Agreement (the “Transfer Earnout”); and (iii) amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the Products achieved by Medtronic over each year of a four-year period beginning on the first full quarter after Medtronic’s first commercial sale of a Product and achievement of the OEM Earnout. The $20.0 million OEM Earnout was achieved in October 2022 and payment was received in November 2022, of which $1.6 million is held in escrow and recorded as restricted cash on the condensed consolidated balance sheets. The $17.0 million Transfer Earnout was achieved in December 2022 and payment was received in January 2023, of which $1.4 million is held in escrow and recorded as restricted cash on the condensed consolidated balance sheets. During the nine months ended September 30, 2023, $6.1 million was earned under item (iii) and recorded as a receivable on the condensed consolidated balance sheet as of September 30, 2023. With the achievement of the OEM Earnout Conditions (as defined in the Asset Purchase Agreement) and upon notice from Medtronic, Medtronic became the Company's exclusive distributor of the Products under the Distribution Agreement. The Company recorded a net gain of $79.5 million during the year ended December 31, 2022 related to the sale of business to Medtronic, calculated as the difference between the non-contingent consideration received, less direct transaction costs and the net carrying amount of the assets sold. The Company recorded the following amounts for the nine months ended September 30, 2023, resulting in a net gain of $5.9 million related to the sale of business to Medtronic, calculated as the difference between the non-contingent consideration earned, less direct transaction costs (in thousands): Nine Months Ended (unaudited) Percentage of Product Net Sales Earnout accrued as of September 30, 2023 $ 6,111 Transaction costs (184) Gain on sale of business, net $ 5,927 The net gain on sale will be adjusted in future periods by the contingent consideration, based on the achievement of the predetermined milestones mentioned above. The sale was accounted for as a derecognition of a group of assets that is a business pursuant to ASC 810 - Consolidation , with the resulting gain classified as operating income within loss from operations on the condensed consolidated statements of operations and comprehensive loss. The sale did not represent a strategic shift having a major effect on the Company's operations and financial results and, consequently, did not qualify as a discontinued operation. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 (unaudited) Amortized Gross Gross Fair Value Available-for-sale securities - short-term: U.S. treasury securities $ 2,968 $ — $ — $ 2,968 Commercial paper 10,665 — — 10,665 Asset-backed securities 742 — — 742 Total available-for-sale securities - short-term 14,375 — — 14,375 Total available-for-sale securities $ 14,375 $ — $ — $ 14,375 December 31, 2022 Amortized Gross Gross Fair Value Available-for-sale securities - short-term: U.S. treasury securities $ 26,906 $ 3 $ (12) $ 26,897 Commercial paper 3,200 2 — 3,202 Yankee debt securities 14,764 — — 14,764 Total available-for-sale securities - short-term 44,870 5 (12) 44,863 Total available-for-sale securities $ 44,870 $ 5 $ (12) $ 44,863 As of September 30, 2023, the Company’s available-for-sale securities classified as short-term of $14.4 million mature in 1 year or less and there were none held long-term. As of December 31, 2022, the Company’s available-for-sale securities classified as short-term of $44.9 million mature in 1 year or less and there were none held long-term. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, December 31, (unaudited) Raw materials $ 10,664 $ 9,179 Work in process 2,416 2,025 Finished goods 2,648 2,123 Total inventory $ 15,728 $ 13,327 |
Lessor Sales-Type Leases
Lessor Sales-Type Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Lessor Sales-Type Leases | Lessor Sales-Type Leases The Company recognizes revenue and costs, as well as leases receivable, at the commencement of embedded sales-type leases within its deferred equipment agreements. There was no lease revenue related to sales-type leases for both the three months ended September 30, 2023 and 2022. Lease revenue related to sales-type leases was $0.5 million and $0.3 million for the nine months ended September 30, 2023 and 2022, respectively. Costs related to embedded leases within the Company’s deferred equipment agreements are included in cost of products sold in the condensed consolidated statements of operations and comprehensive loss. As of September 30, 2023 and December 31, 2022, a balance of $0.6 million for both periods for short-term leases receivable is recorded in prepaid expenses and other current assets on the condensed consolidated balance sheets, and a balance of $0.3 million and $0.5 million, respectively, for long-term leases receivable is recorded in other assets related to sales-type leases. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, NetThe Company’s property and equipment, net, consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Medical diagnostic equipment $ 14,995 $ 14,826 Furniture and fixtures 452 432 Office equipment 1,561 1,556 Laboratory equipment and software 5,226 5,148 Leasehold improvements 974 580 Construction in process 1,675 2,166 Total property and equipment 24,883 24,708 Less: accumulated depreciation (18,272) (15,487) Property and equipment, net $ 6,611 $ 9,221 Property and equipment includes certain medical diagnostic equipment and AcQMap Systems located at customer premises. The Company retains ownership of the equipment and has the right to remove the equipment if it is not being used according to expectations. The Company records the cost of equipment to cost of sales on the condensed consolidated statements of operations and comprehensive loss when it is subsequently sold or the Company enters into a sales-type lease agreement. See Note 6 - Lessor Sales-Type Leases for additional details. |
Intangible Assets
Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible Assets The following table presents intangible assets activity for the nine months ended September 30, 2023 (in thousands): Intangible Balance, December 31, 2022 $ 1,583 Amortization expense (150) Balance, September 30, 2023 (unaudited) $ 1,433 Intangible Assets The tables below present the details of intangible assets as of September 30, 2023 and December 31, 2022 (dollars in thousands): September 30, 2023 Estimated Weighted Intangible Accumulated Balance (unaudited) Licensed intangibles 10.0 7.2 $ 2,000 $ (567) $ 1,433 Total intangible assets $ 2,000 $ (567) $ 1,433 December 31, 2022 Estimated Weighted Intangible Accumulated Balance Licensed intangibles 10.0 7.9 2,000 (417) 1,583 Total intangible assets $ 2,000 $ (417) $ 1,583 The Company recorded amortization expense related to the above intangible assets of $0.1 million for both the three months ended September 30, 2023 and 2022, and $0.2 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. The following table presents the future amortization expense associated with amortizable intangible assets as of September 30, 2023 (in thousands): Total Three months ending December 31, 2023 $ 50 Year ending December 31, 2024 200 Year ending December 31, 2025 200 Year ending December 31, 2026 200 Year ending December 31, 2027 200 Thereafter 583 Total future amortization $ 1,433 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Compensation and related expenses $ 5,264 $ 6,919 Professional fees 192 126 Deferred revenue 349 326 Sales and use tax 187 639 Clinical studies 374 390 Clinician Council payable 241 216 Accrued royalties 108 159 Accrued restructuring 35 45 Other 688 866 Total accrued liabilities $ 7,438 $ 9,686 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt Outstanding debt as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, December 31, (unaudited) 2022 Credit Agreement (1) $ 36,750 $ 36,776 Total outstanding debt, gross 36,750 36,776 Less: Unamortized debt discount and fees (1,989) (2,342) Total outstanding debt, long-term $ 34,761 $ 34,434 (1) The 2022 Credit Agreement includes final payment fees of $1.8 million. 2022 Amended and Restated Credit Agreement On June 30, 2022, the Company amended and restated its prior debt facility. The amended and restated credit agreement (as amended by Amendment No. 1, dated August 4, 2023, and Amendment No. 2, dated November 8, 2023, and as further amended from time to time, the "2022 Credit Agreement") is with related parties Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P. (collectively referred to as “Deerfield” or "Lenders") and is for an aggregate principal amount of $35.0 million and has a 5-year term. Proceeds from the 2022 Credit Agreement, along with cash on hand, were used to repay the prior debt facility and to pay related fees and expenses. The 2022 Credit Agreement bears an annual interest of 9% plus the one-month adjusted term Secured Overnight Financing Rate (applying a 2.5% minimum rate). From date of closing, amortization payments are due as follows: • 15% of the principal due at the end of month 36; • 15% of the principal due at the end of month 48; and • 70% due at the end of month 60. The 2022 Credit Agreement is subject to prepayment penalties and provides for final payment fees of an additional $1.8 million due upon prepayment, on the maturity date or upon acceleration. The 2022 Credit Agreement is secured by a first-priority perfected lien on and security interest in substantially all of the Company’s existing and after-acquired tangible and intangible assets, subject to certain exceptions noted therein. The 2022 Credit Agreement is subject to certain customary affirmative covenants, representations and warranties and other terms and conditions. It also contains certain customary negative covenants, including, but not limited to, restrictions on the Company’s ability and that of its subsidiaries to merge and consolidate with other companies, incur indebtedness, grant liens or security interests on assets, pay dividends or make other restricted payments, sell or otherwise transfer assets or enter into transactions with affiliates. In addition, the 2022 Credit Agreement includes customary events of default and other provisions that could require all amounts due thereunder to become immediately due and payable, either automatically or at the option of the Lenders, if the Company fails to comply with the terms. On August 4, 2023, the Company and Deerfield entered into that certain Amendment No. 1, dated August 4, 2023 (“Amendment No.1”) to the 2022 Credit Agreement. Pursuant to Amendment No. 1, the 2022 Credit Agreement was amended to decrease the amount of cash the Company is required to maintain pursuant to the minimum liquidity covenant in the 2022 Credit Agreement to $5,000,000 for a period of 18 months, at which point the amount required under the minimum liquidity covenant shall increase to $20,000,000 (or, if certain conditions are met, $10,000,000), in exchange for a fee paid by the Company. On November 8, 2023, the Company and Deerfield entered into that certain Amendment No. 2, dated November 8, 2023 (“Amendment No. 2”) to the 2022 Credit Agreement. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities the Company may engage in; and (iii) require the Company to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by the Company. In connection with entering into the 2022 Credit Agreement, the Company entered into a warrant purchase agreement (the "2022 Warrant Purchase Agreement") with Deerfield, pursuant to which the Company issued to Deerfield warrants to purchase up to an aggregate 3,779,018 shares of the Company's common stock at an exercise price of $1.1114 per warrant share for a period of eight years following issuance (the "2022 Warrants"). The 2022 Warrants represent a freestanding financial instrument and are conditionally puttable at the holder’s option upon an event that is outside of the Company’s control. Therefore, the 2022 Warrants are classified as liability pursuant to ASC 480 , Distinguishing Liabilities from Equity , initially and subsequently recognized at fair value, with changes in fair value recognized in the statements of operations and comprehensive loss. Refer to Fair Value Measurements in Note 2 - Summary of Significant Accounting Policies and Note 13 - Warrants for more information. |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Operating Leases | Operating LeasesThe Company leases approximately 50,800 square feet of office space for its corporate headquarters and manufacturing facility in Carlsbad, California under a non-cancelable operating lease that expires on December 31, 2027. The lease is subject to variable charges for common area maintenance and other costs that are determined annually based on actual costs. The base rent is subject to an annual increase each year. The Company has a renewal option for an additional five-year term upon the expiration date of the lease, which has been excluded from the calculation of the right-of-use asset as it is not reasonably certain to be exercised. Additionally, the Company leases approximately 3,900 square feet of office space in Zaventem, Belgium under a non-cancelable operating lease that expires on December 31, 2024. The lease is subject to variable charges that are determined annually for common area maintenance and other costs based on actual costs, and base rent is subject to an annual increase each year based on an index rate. The following table summarizes quantitative information about the Company’s operating leases for the nine months ended September 30, 2023 and 2022 (dollars in thousands): Nine Months Ended September 30, 2023 2022 (unaudited) Operating cash flows from operating leases $ 282 $ 631 Weighted average remaining lease term – operating leases (in years) 4.2 3.4 Weighted average discount rate – operating leases 7.0% 7.0% The following table provides the components of the Company’s operating lease expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Operating leases Operating lease cost $ 252 $ 252 $ 755 $ 768 Variable lease cost 81 77 243 216 Total operating lease expense $ 333 $ 329 $ 998 $ 984 As of September 30, 2023, future minimum payments under the non-cancelable operating leases under ASC 842 were as follows (in thousands): Three months ending December 31, 2023 $ 138 Year ending December 31, 2024 1,160 Year ending December 31, 2025 1,151 Year ending December 31, 2026 1,185 Year ending December 31, 2027 1,221 Total 4,855 Less: present value discount (686) Operating lease liabilities $ 4,169 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and ContingenciesThe Company and certain of its current and former officers have been named as defendants in two putative securities class action lawsuits filed in the United States District Court for the Southern District of California on February 14, 2022 and March 23, 2022. On July 19, 2022, the court consolidated the two actions, appointed a lead plaintiff and appointed lead counsel for the proposed class. On September 16, 2022, the lead plaintiff filed a consolidated amended complaint. The defendants thereafter filed a motion to dismiss. On September 27, 2023, the court granted the defendant’s motion to dismiss in its entirety, but gave plaintiffs leave to file an amended complaint. On October 27, 2023, the plaintiffs filed a second amended complaint asserting similar claims. We are defending the action. Due to the complex nature of the legal and factual issues involved in these class action matters, the outcome is not presently determinable and any loss is neither probable nor reasonably estimable. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants As of September 30, 2023 and December 31, 2022, the outstanding warrants to purchase the Company’s common stock consisted of the following: Exercise Price Expiration Date September 30, December 31, (unaudited) Warrants issued in 2015 $ 5.25 1/30/25 3,808 3,808 Warrants issued with 2018 Convertible Notes $ 0.10 6/7/28 346,689 346,689 Warrants issued with 2018 Term Loan $ 16.67 7/31/28 26,998 26,998 Warrants issued with 2019 Credit Agreement $ 16.67 5/20/29 419,992 419,992 Warrants issued with 2022 Credit Agreement $ 1.11 6/30/30 3,779,018 3,779,018 Total Warrants 4,576,505 4,576,505 There was no warrant activity during the nine months ended September 30, 2023. The Company’s warrants provide the holder the option to purchase a specified number of shares for a specified price within a specified duration or upon the occurrence of a specific event. The holder may exercise the warrant either by cash payment or by exercise pursuant to a cashless exercise whereby a calculated number of shares are withheld upon exercise to satisfy the exercise price. The warrants do not provide the holder any voting rights until the warrants are exercised. In accordance with ASC 480, the 2022 Warrants are recorded at fair value on the condensed consolidated balance sheets as a warrant liability. Changes in fair value are recognized as a change in fair value of warrant liability in the condensed consolidated statements of operations and comprehensive loss. For the nine months ended September 30, 2023, a favorable fair value change of $1.5 million was recognized. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Series A Common Equivalent Preferred Stock In August 2021, the Company entered into exchange agreements (the “Exchange Agreements”) with four investors pursuant to which the investors exchanged 6,665,841 shares of the Company’s common stock for 6,666 shares of a new series of non-voting convertible preferred stock of the Company designated as “Series A Common Equivalent Preferred Stock,” par value $0.001 per share (the "Preferred Stock"). In connection with the issuance of the Preferred Stock pursuant to the Exchange Agreements, on August 23, 2021, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Common Equivalent Preferred Stock of the Company with the Secretary of State of the State of Delaware. The Preferred Stock ranks senior to the common stock with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, having a liquidation preference equal to its par value of $0.001 per share. The Preferred Stock will participate equally and ratably on an as-converted basis with the holders of common stock in all cash dividends paid on the common stock. The Preferred Stock is non-voting. Upon election, each holder may convert each share of Preferred Stock into 1,000 shares of common stock, except to the extent that following such conversion the number of shares of common stock held by such holder, its affiliates and any other persons whose beneficial ownership of common stock would be aggregated with such holder’s for purposes of Section 13(d) of the Exchange Act including shares held by any “group” (as defined in Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") and applicable regulations of the Securities and Exchange Commission ("SEC")) of which such holder is a member, but excluding shares beneficially owned by virtue of the ownership of securities or rights to acquire securities that have limitations on the right to convert, exercise or purchase similar to the limitation set forth in the Series A Certificate of Designation, exceeds 4.9% (or, at the election of the holders, OrbiMed Private Investments IV, LP or OrbiMed Royalty Opportunities II, LP, made by delivering at least 61 days advance written notice to the Company of its intention to increase the beneficial ownership cap applicable to such holder, 9.9%) of the total number of shares of common stock then issued and outstanding. Common Stock During the nine months ended September 30, 2023 and 2022, stock options to acquire 3,218 shares and 98,772 shares, respectively, were exercised for shares of the Company's common stock with proceeds of less than $0.1 million and $0.1 million, respectively. Additionally in conjunction with the 2020 Employee Stock Purchase Plan (the "2020 ESPP"), during the nine months ended September 30, 2023 and 2022, 45,162 shares and 94,226 shares, respectively, of common stock were issued for consideration of less than $0.1 million and $0.2 million, respectively. During the nine months ended September 30, 2023 and 2022, the Company issued 686,898 shares and 223,567 shares, respectively, of common stock upon vesting of RSUs. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2022 Inducement Equity Incentive Plan The 2022 Inducement Equity Incentive Plan (the “2022 Plan”), which permits the granting of nonstatutory stock options, RSUs, RSAs, stock appreciation rights, performance share units ("PSUs"), performance shares and other equity-based awards to employees, directors and consultants, became effective on March 30, 2022. As of September 30, 2023, 6,000,000 shares of common stock were authorized for issuance under the 2022 Plan, of which 5,715,233 remain available for issuance under the 2022 Plan. 2020 Equity Incentive Plan The 2020 Equity Incentive Plan (the “2020 Plan”), which permits the granting of nonstatutory stock options, RSAs, RSUs, stock appreciation rights, PSUs, performance shares and other equity-based awards to employees, directors and consultants became effective on August 5, 2020. As of September 30, 2023, 5,573,491 shares of common stock were authorized for issuance under the 2020 Plan, including 1,142,186 additional shares that were authorized on January 1, 2023. As of September 30, 2023, 2,880,276 shares remain available for issuance under the 2020 Plan. 2011 Equity Incentive Plan The Company’s 2011 Equity Incentive Plan (the “2011 Plan”) permits the granting of incentive stock options, non-statutory stock options, RSAs, RSUs and other stock-based awards to employees, directors, officers and consultants. As of September 30, 2023, 263,571 shares of common stock were authorized for issuance under the 2011 Plan and no shares remain available for issuance under the 2011 Plan. No additional awards will be granted under the 2011 Plan. Shares that become available for issuance from the outstanding awards under the 2011 Plan due to forfeiture, or otherwise, will become available for issuance from future awards under the 2020 Plan. Stock Options Stock options granted generally vest over four years and have a ten-year contractual term. The fair value of each employee and non-employee stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The Company's common stock became publicly traded in August 2020 and lacks company-specific historical and implied volatility information. Therefore, the Company estimates its expected stock volatility based on the historical volatility of a set of publicly traded peer companies. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined using the “simplified” method for awards. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following assumptions were used to estimate the fair value of stock options for the nine months ended September 30, 2023 and 2022: Nine Months Ended September 30, 2023 2022 (unaudited) Risk-free interest rate 3.91% - 4.27% 1.76% - 3.39% Expected dividend yield — — Expected term in years 5.5 - 5.6 5.5 - 6.0 Expected volatility 75% - 85% 75% - 90% The Company's stock option activity for the nine months ended September 30, 2023 was as follows: Stock Weighted Weighted Aggregate Outstanding as of December 31, 2022 2,898,821 $ 6.83 6.9 $ 79 Options granted 755,580 1.28 Options exercised (3,218) 1.34 $ 1 Options forfeited (1,562,043) 10.72 Outstanding as of September 30, 2023 (unaudited) 2,089,140 $ 1.93 7.6 $ 23 Options vested and exercisable as of September 30, 2023 (unaudited) 1,098,279 $ 2.43 6.4 $ 23 For options in the money, the aggregate intrinsic value for options outstanding in the above table represents the product of the number of options outstanding multiplied by the difference between the per share fair value of the Company’s common stock on the last day of the fiscal period, which was $0.70 and $1.15 as of September 30, 2023 and December 31, 2022, respectively, and the exercise price. The aggregate intrinsic value for options exercised in the above table represents the product of the number of options exercised multiplied by the difference between the per share fair value of the Company’s stock on the date of exercise and the exercise price. The weighted average grant date fair value per share for the stock option awards granted during the nine months ended September 30, 2023 was $0.87. As of September 30, 2023, the total unrecognized compensation related to unvested stock option awards granted was $2.3 million, which the Company expects to recognize over a weighted-average period of approximately 1.3 years. Restricted Stock Units (RSUs) The Company’s RSU activity for the nine months ended September 30, 2023 was as follows: Number Weighted Unvested as of December 31, 2022 1,659,898 $ 4.17 Granted 1,881,020 1.30 Forfeited (372,930) 4.49 Vested (877,260) 2.82 Unvested as of September 30, 2023 (unaudited) 2,290,728 $ 2.28 As of September 30, 2023, there was $3.7 million of unrecognized compensation related to unvested RSUs, which the Company expects to recognize over a weighted-average period of approximately 1.6 years. Employee Stock Purchase Plan The 2020 ESPP permitted individual employees to purchase shares of the Company’s common stock from amounts accumulated under payroll deductions. The 2020 ESPP became effective on August 5, 2020, wherein 645,105 shares of common stock were authorized. Additional shares of common stock were historically allocated to the 2020 ESPP by the determination of the Compensation Committee of the Company’s Board of Directors, in its sole discretion, and by evergreen provisions in the plan authorization. Automatically authorized in 2023 were 252,042 shares under the plan's evergreen provision. As of September 30, 2023, 669,017 shares were available for purchase under the Company's 2020 ESPP. The 2020 ESPP was implemented in consecutive offering periods with a new offering period commencing on the first trading day on or after May 15 and November 15 of each year and terminating on the last trading day on or before November 14 and May 14, respectively. On each purchase date, which falls on the last date of each offering period, 2020 ESPP participants will purchase shares of common stock at a price per share equal to 85% of the lesser of (1) the fair market value per share of the common stock on the offering date or (2) the fair market value of the common stock on the purchase date. The occurrence and duration of offering periods under the 2020 ESPP are subject to the determinations of the Compensation Committee of the Company’s Board of Directors, in its sole discretion. As part of the Restructuring, the Company’s Board of Directors resolved to terminate the 2020 ESPP effective November 8, 2023, and return to the respective contributors all contributions made under the 2020 ESPP during the purchase period ending November 14, 2023. The fair value of the 2020 ESPP shares used in determining compensation expense is estimated using the Black-Scholes option pricing model. Total Stock-Based Compensation The following table summarizes the total stock-based compensation expense for the stock options, PSUs, RSUs, RSAs and ESPP expense recorded in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Cost of products sold $ 146 $ 93 $ 373 $ 544 Research and development 317 349 999 1,417 Selling, general and administrative 815 1,442 3,543 5,536 Total stock-based compensation $ 1,278 $ 1,884 $ 4,915 $ 7,497 |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per common share excludes the potential impact of the Company’s convertible preferred stock, common stock options, RSUs, RSAs, intended ESPP purchases and warrants because the Company's net losses would cause such shares to be anti-dilutive. Therefore, as the Company recorded net losses in the periods presented, basic and diluted net loss per common share are the same. The table below provides potentially dilutive securities not included in the calculation of the diluted net loss per common share because to do so would be anti-dilutive: Nine Months Ended September 30, 2023 2022 (unaudited) Shares issuable upon: Conversion of Series A Common Equivalent Preferred Stock 6,665,841 6,665,841 Exercise of common stock warrants 4,576,505 4,576,505 Exercise of stock options 1,098,279 3,267,782 Vesting of RSUs and RSAs 2,290,728 1,761,181 Issuance of shares under 2020 ESPP 61,361 — Total potentially dilutive securities 14,692,714 16,271,309 |
401(k) Retirement Plan
401(k) Retirement Plan | 9 Months Ended |
Sep. 30, 2023 | |
Retirement Benefits [Abstract] | |
401(k) Retirement Plan | 401(k) Retirement PlanThe Company has a 401(k) retirement savings plan that provides retirement benefits to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations. The Company provided no contributions to the 401(k) retirement savings plan for the three and nine months ended September 30, 2023 and 2022. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Consulting Agreement The Company has a consulting agreement with the chairman of the Company’s Board of Directors. The Company recorded less than $0.1 million of expense related to the agreement for both the three months ended September 30, 2023 and 2022, and approximately $0.1 million and $0.2 million for the nine months ended September 30, 2023 and 2022, respectively. Credit Agreements The Company's prior credit agreement (the "2019 Credit Agreement") was between the Company and related parties OrbiMed Royalty Opportunities II, LP and Deerfield Private Design Fund II, L.P., and provided for a loan of up to $70.0 million with a maturity date of May 20, 2024. On June 30, 2022, the loan balance of $40.0 million was repaid in full out of the proceeds of the 2022 Credit Agreement. The 2022 Credit Agreement with related parties Deerfield Private Design Fund III, L.P. and Deerfield Partners, L.P. replaced the 2019 Credit Agreement and provides for an aggregate principal amount of $35.0 million and a maturity date five years from the closing of the loan. Refer to Note 10 - Debt for additional details. The liability for the loan balance related to the 2022 Credit Agreement and the 2019 Credit Agreement recorded on the Company's consolidated balance sheets was $34.4 million and $40.4 million as of December 31, 2022 and 2021, respectively. The Company recorded interest expense related to the debt on the consolidated statements of operations and comprehensive loss of $5.1 million and $5.7 million for the years ended December 31, 2022 and 2021, respectively. Warrants In connection with the 2022 Credit Agreement, the Company entered into the 2022 Warrant Purchase Agreement with Deerfield, pursuant to which the Company issued warrants for the purchase up to an aggregate 3,779,018 shares of the Company’s common stock at an exercise price of $1.1114 per share for a period of eight years following issuance. Refer to Note 13 - Warrants for additional details. Registration Rights Agreement On June 30, 2022, in connection with the issuance of the 2022 Warrants, the Company also entered into a registration rights agreement (the “Registration Rights Agreement”) with Deerfield, pursuant to which the Company filed a shelf registration statement on Form S-3 with the SEC to register the resale of certain securities held by Deerfield and their affiliates (the “Registrable Securities”). In addition, for a period of five years following the execution of the Registration Rights Agreement, or until all Registrable Securities are registered or no longer subject to restrictions on transfer (whichever is earlier), Deerfield will hold certain “piggy-back” registration rights with respect to registration statements filed during such period. The Company will generally pay all reasonable expenses incidental to its obligations and performance under the Registration Rights Agreement, other than underwriting discounts and commissions and such other charges. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Listing Transfer to Nasdaq Capital Market On May 1, 2023, the Company received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock, par value $0.001 per share (the “common stock”), for the prior 30 consecutive business days, the Company was not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on The Nasdaq Global Market (the “Bid Price Requirement”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was granted 180 calendar days, or until October 30, 2023, to regain compliance with the Bid Price Requirement. On October 19, 2023, the Company applied to transfer its securities from The Nasdaq Global Market to The Nasdaq Capital Market. Along with its application, the Company also provided written notice to the Staff of its intention to cure the deficiency. On October 27, 2023, the Company received a letter from the Staff notifying the Company that it was eligible for an additional 180-calendar day period, or until April 29, 2024, to regain compliance with the Bid Price Requirement and approving the Company’s application to list its securities on The Nasdaq Capital Market. The Company’s securities were transferred to The Nasdaq Capital Market at the opening of business on October 31, 2023. The Company’s common stock continues to trade under the symbol “AFIB”. The Nasdaq Capital Market is a continuous trading market that operates in substantially the same manner as The Nasdaq Global Market and listed companies must meet certain financial requirements and comply with Nasdaq’s corporate governance requirements. The Company will continue to monitor the closing bid price of its common stock and consider implementing available options to regain compliance with the Bid Price Requirement within the allotted compliance period, including by effecting a reverse stock split, if necessary. If at any time during the allotted compliance period, the closing bid price of the Company’s common stock is at least $1.00 per share for at least a minimum of 10 consecutive business days, Nasdaq will provide the Company with written confirmation of compliance and the matter will be closed. If the Company does not regain compliance within the allotted compliance period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Bid Price Requirement within the allotted compliance period, or that if the Company appeals a Nasdaq determination, that such an appeal would be successful. Strategic Realignment of Resources and Corporate Restructuring On November 6, 2023, the Company’s Board of Directors approved a strategic realignment of resources and corporate restructuring (i.e., the Restructuring) designed to reallocate capital from its mapping and ablation businesses to its left-heart access distribution relationship with Medtronic. The Company will wind down its mapping and ablation businesses and will no longer manufacture or distribute the AcQMap Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate Force-Sensing Ablation Catheter, the AcQGuide Max 2.0 steerable sheath, and associated accessories, and will explore strategic alternatives for these businesses (including a potential sale of related assets). Following the Restructuring, the Company will focus exclusively on the manufacturing and distribution of left-heart access products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments it may become eligible to receive under the Asset Purchase Agreement with Medtronic. As part of the Restructuring, the Company initiated a reduction in its current workforce of approximately 160 employees, representing approximately 65% of the Company’s employees, that is expected to be completed by the first quarter of 2024. In compliance with the Worker Adjustment and Retraining Notification Act, the Company has provided pre-termination notices to affected employees and government authorities where required. The Company plans to enter into retention arrangements with certain employees who are expected to remain with the Company to assist with the Restructuring and operation of its left-heart access distribution business. The Company estimates it will incur approximately $21 million to $32 million of pre-tax restructuring and exit-related charges, of which $2 million to $3 million represents future cash expenditures for the payment of severance and related benefit costs, $3 million to $4 million represents future cash expenditures for the payment of retention bonuses to certain employees that will assist with the Restructuring, $2 million to $5 million represents future cash expenditures for other restructuring costs, and approximately $14 million to $20 million represents non-cash pre-tax impairment charges in connection with the disposition of certain assets, including inventory, fixed assets and intangibles. The Company expects that a majority of the non-cash charges will be incurred in the fourth quarter of 2023, while the majority of the future cash expenditures charges will be incurred in the first quarter of 2024, and that the Restructuring will be substantially complete in the first quarter of 2024. Potential position eliminations in each country are subject to local law and consultation requirements, which may extend the Restructuring implementation beyond the first quarter of 2024 in certain countries. The charges that the Company expects to incur are subject to a number of assumptions, including local law requirements in various jurisdictions, and actual expenses may differ from the estimates disclosed above. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Restructuring. Amendment to 2022 Credit Agreement To facilitate the transactions contemplated under the Restructuring, the Company and Deerfield entered into Amendment No. 2 to the 2022 Credit Agreement. Pursuant to Amendment No. 2, the 2022 Credit Agreement was amended to, among other things: (i) adjust and increase the amortization schedule such that payments commence on June 30, 2024 and are made 12, 24 and 36 months (i.e., the scheduled maturity date) following June 30, 2024; (ii) limit the business activities the Company may engage in; and (iii) require the Company to maintain a minimum liquidity of $10,000,000 at all times, in exchange for fees paid by the Company. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and note disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period. |
Principles of Consolidation | Principles of Consolidation The condensed consolidated financial statements include the accounts of Acutus Medical, Inc. and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and disclosures of contingent assets and liabilities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment and reportable segment. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts, the balances of which, at times and as of September 30, 2023 and December 31, 2022, exceeded federally insured limits. Restricted cash consists of (i) deposited cash collateral for the Company’s corporate credit card program and (ii) cash received for the sale of business to Medtronic held in an indemnity escrow account until certain terms of sale are met. |
Marketable Securities | Marketable Securities The Company’s marketable securities portfolio consists of investments in money market funds, commercial paper, U.S. treasury securities, Yankee debt securities, and asset-backed securities. The Company considers its debt securities to be available-for-sale securities. Available-for-sale securities are classified as cash equivalents or short-term or long-term marketable securities based on the maturity date at time of purchase and their availability to meet current operating requirements. Marketable securities that mature in three months or less from the date of purchase are classified as cash equivalents. Marketable securities, excluding cash equivalents, that mature in one year or less are classified as short-term available-for-sale securities and are reported as a component of current assets. Securities that are classified as available-for-sale are measured at fair value with temporary unrealized gains and losses reported in other comprehensive income (loss), and as a component of stockholders’ equity until their disposition or maturity. See Fair Value Measurements, below. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s current intent and ability to sell the security if it is required to do so. Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific-identification method. Marketable securities are subject to a periodic impairment review. The Company may recognize an impairment charge when a decline in the fair value of investments below the cost basis is determined to be other-than-temporary. In determining whether a decline in market value is other-than-temporary, various factors are considered, including the cause, duration of time and severity of the impairment, any adverse changes in the investee’s financial condition and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. Declines in value judged to be other-than-temporary are included in the Company’s condensed consolidated statements of operations and comprehensive loss. The Company did not record any other-than-temporary impairments related to marketable securities in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off-Balance Sheet RiskFinancial instruments that potentially subject the Company to credit risk consist principally of cash, cash equivalents, restricted cash, accounts receivable and marketable securities. The Company has not experienced losses on these accounts, and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company accounts for revenue earned from contracts with customers under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers (“ASC 606”), and ASC 842, Leases ("ASC 842"). The core principle of ASC 606 is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: • Step 1: Identify the contract with the customer. • Step 2: Identify the performance obligations in the contract. • Step 3: Determine the transaction price. • Step 4: Allocate the transaction price to the performance obligations in the contract. • Step 5: Recognize revenue when, or as, the company satisfies a performance obligation. ASC 842 provides guidance on determining whether an agreement contains a lease. ASC 842 defines a lease as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period of time in exchange for consideration. For new customers, the Company places its medical diagnostic equipment, the AcQMap System, at customer sites under evaluation agreements and generates revenue from the sale of disposable products used with the AcQMap System. Disposable products primarily include AcQMap Catheters and AcQGuide Steerable Sheaths. Outside of the United States, the Company also has the Qubic Force Device which generates revenue from the sale of the AcQBlate Force Ablation Catheters. The Company provides the disposable products in exchange for consideration, which occurs when a customer submits a purchase order and the Company provides disposables at the agreed upon prices in the invoice. Generally, customers purchase disposable products using separate purchase orders after the equipment has been provided to the customer for free with no binding agreement or requirement to purchase any disposable products. The Company has elected the practical expedient and accounting policy election to account for the shipping and handling as activities to fulfill the promise to transfer the disposable products and not as a separate performance obligation. Additionally, the Company sells the AcQMap System to customers along with software updates on a when-and-if-available basis, as well as the Qubic Force Device and a transseptal crossing line of products which can be used in a variety of heart procedures and does not need to be accompanied with an AcQMap System or Qubic Force Device. Included in the transseptal crossing line of products are primarily the AcQRef Introducer Sheath, the AcQGuide Sheaths and the AcQCross Transseptal Dilator/Needle. The Company also enters into deferred equipment agreements that are generally structured such that the Company agrees to provide an AcQMap System at no up-front charge, with title of the device transferring to the customer at the end of the contract term, in exchange for the customer’s commitment to purchase disposables at a specified price over the term of the agreement, which generally ranges from two Lastly, the Company enters into short-term operating leases for the rental of the AcQMap System after an evaluation. These lease agreements impose no requirement on the customer to purchase the equipment, and the equipment is not transferred to the customer at the end of the lease term. The short-term nature of the lease agreements does not result in lease payments accumulating to an amount that equals the value of the equipment nor is the lease term reflective of the economic life of the equipment. The Company’s contracts primarily include fixed consideration. Generally, there are no discounts, rebates, returns or other forms of variable consideration. Customers are generally required to pay within 30 to 60 days. The delivery of disposable products are performance obligations satisfied at a point in time. The disposable products are shipped Free on Board (“FOB”) shipping point or FOB destination. For disposable products that are shipped FOB shipping point, the customer has the significant risks and rewards of ownership and legal title to the assets when the disposable products leave the Company’s shipping facilities, at which point the customer obtains control and thus revenue is recognized at that point in time. Revenue is recognized on delivery for disposable products shipped FOB destination. For direct customers, the installation and delivery of the AcQMap System is satisfied at a point in time when the installation is complete, which is when the customer can benefit and has control of the system. For AcQMap System sold to Biotronik SE & Co. KG (“Biotronik”), the installation is not a performance obligation as it is performed by Biotronik, and therefore the AcQMap System is satisfied at a point in time when they have control of the system. The Company’s software updates and equipment service performance obligations are satisfied evenly over time as the customer simultaneously receives and consumes the benefits of the Company’s performance for these services throughout the service period. The Company allocates the transaction price to each performance obligation identified in the contract based on the relative standalone selling price (“SSP”). The Company determines SSP for the purposes of allocating the transaction price to each performance obligation based on the adjusted market assessment approach that maximizes the use of observable inputs, which include, but are not limited to, sales transactions where the specific performance obligations are sold separately, Company list prices and specific offers to customers. Except for the deferred equipment agreements noted above, the Company’s contracts with customers generally have an expected duration of one year or less, and therefore the Company has elected the practical expedient in ASC 606 to not disclose information about its remaining performance obligations. Any incremental costs to obtain contracts are recorded as selling, general and administrative ("SG&A") expense as incurred due to the short duration of the Company’s contracts. The Company’s contract balances consisted solely of accounts receivable as of September 30, 2023 and December 31, 2022. In May 2020, the Company entered into bi-lateral distribution agreements (the “Bi-Lateral Distribution Agreements”) with Biotronik. Pursuant to the Bi-Lateral Distribution Agreements, the Company obtained a non-exclusive license to distribute a range of Biotronik’s products and accessories in the United States, Canada, China, Hong Kong and multiple Western European countries under the Company’s private label. Moreover, if an investigational device exemption (“IDE”) clinical trial is required for these products to obtain regulatory approval in the United States, or a clinical trial is required for these products to obtain regulatory approval in China, the Company will obtain an exclusive distribution right in such territories for a term of up to five years commencing on the date of regulatory approval if the Company covers the cost of the IDE or other clinical trial and the Company conducts such study within a specified period. Biotronik also agreed to distribute the Company’s products and accessories in Germany, Japan, Mexico, Switzerland and multiple countries in Asia-Pacific, Eastern Europe, the Middle East and South America. The Company also granted Biotronik a co-exclusive right to distribute these products in Hong Kong. Each party will pay to the other party a specified transfer price on the sale of the other party’s products and, accordingly, will earn a distribution margin on the sale of the other party’s products. The foregoing description applies to products that will no longer be manufactured and sold by the Company upon completion of the Restructuring. See Note 1 – Organization and Description of Business – Liquidity, Capital Resources and Going Concern , above. In 2022, the Company sold its left-heart access transseptal crossing business to Medtronic. In connection with the sale, the Company entered into a distribution agreement (the "Distribution Agreement") with Medtronic, pursuant to which the Company acts as the original equipment manufacturer ("OEM") supplier of these products. The Company will produce and sell the products to Medtronic for a period of up to four years. Revenue is recognized when the title to the products are transferred to Medtronic, which occurs when the products are shipped from our facility (or FOB shipping point). See Note 3 – Sale of Business , below, for further details. As part of the Restructuring, the Company will focus exclusively on the manufacturing and distribution of the left-heart access Products to Medtronic to continue to generate revenue from such sales and potentially earn the associated earnout payments. |
Inventory | Inventory Inventory is stated at the lower of cost (first-in, first-out basis) or net realizable value. The Company recorded write-downs for excess and obsolete inventory of $0.3 million and $0.2 million for the three months ended September 30, 2023 and 2022, respectively, and $0.9 million and $2.6 million for the nine months ended September 30, 2023 and 2022, respectively, based on management’s review of inventories on hand, comparisons to estimated future usage and sales, observed shelf-life and assumptions about the likelihood of obsolescence. |
Accounts Receivable | Accounts Receivable Trade accounts receivable are recorded net of allowances for uncollectible accounts. The Company evaluates the collectability of its accounts receivable based on various factors including historical experience, the length of time the receivables are past due and the financial health of the customer. The Company reserves specific receivables if collectability is no longer reasonably assured. Based upon the assessment of these factors, the Company did not record an allowance for uncollectible accounts as of September 30, 2023 or December 31, 2022. Pursuant to the Asset Purchase Agreement with Medtronic, the Company was eligible to receive the Transfer Earnout, a contingent cash consideration of $17.0 million upon the Company’s initial submission for CE Mark certification. The Company met this condition as of December 31, 2022 and recorded a receivable on the consolidated balance sheets for the year then ended. Medtronic provided full payment in January 2023. See Note 3 - Sale of Business for additional details. In addition, beginning in February 2023, following Medtronic's first commercial sale of the left-heart access Products after the Company's achievement of the OEM Earnout (as such terms are defined in Note 3 - Sale of Business , below), the Company became eligible to earn amounts equal to 100%, 75%, 50% and 50%, respectively, of quarterly Net Sales (as defined in the Asset Purchase Agreement) from sales of the left-heart access Products achieved by Medtronic each year over four years. During the nine months ended September 30, 2023, the Company earned $6.1 million based on Medtronic's left-heart access Products sales and recorded a corresponding receivable on the condensed consolidated balance sheets as of the period then ended. |
Employee Retention Credit Receivable | Employee Retention Credit Receivable The Employee Retention Credit is a refundable U.S. tax credit separate from tax based on income for businesses that continued to pay employees while shut down due to the COVID-19 pandemic or had significant declines in gross receipts from March 13, 2020 to December 31, 2021. The Company applied for the tax credit in 2022 and as of September 30, 2023, the entire $6.8 million claimed tax credit has been refunded to the Company, of which $4.7 million was received during the nine months ended September 30, 2023. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets, generally three |
Intangible Assets | Intangible Assets The Company’s intangible assets consist of a license agreement with Biotronik. The Company determines the appropriate useful life of its finite-lived intangible assets by performing an analysis of expected cash flows of the acquired assets. Finite-lived intangible assets are amortized over their estimated useful lives using the straight-line method, which approximates the pattern in which the economic benefits are consumed. Acquired in-process technology is classified as a finite-lived intangible and amortized accordingly. Indefinite-lived intangible assets are tested for impairment at least annually and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Indefinite-lived intangible assets are impaired if their estimated fair values are less than their carrying value. |
Goodwill | Goodwill Goodwill represents the excess of the purchase price of an entity over the estimated fair value of the assets acquired and liabilities assumed, and it is presented as goodwill in the accompanying condensed consolidated balance sheets. Under ASC 350, Intangibles – Goodwill and Other (“ASC 350”), goodwill is not amortized but is subject to periodic impairment testing. ASC 350 requires that an entity assign its goodwill to reporting units and test each reporting unit’s goodwill for impairment at least on an annual basis and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. In the evaluation of goodwill for impairment, which is performed annually during the fourth quarter, the Company first assesses qualitative factors to determine whether the existence of events or circumstances led to a determination that it was more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, it is determined that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, the Company is required to perform the |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment and finite-lived intangible assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss is recognized when the asset’s carrying value exceeds the total undiscounted cash flows expected from its use and eventual disposition. The amount of the impairment loss is determined as the excess of the carrying value of the asset over its fair value. For the three and nine months ended September 30, 2023 and 2022, the Company determined that there was no impairment of property and equipment or intangible assets. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The assets, liabilities and results of operations of Acutus Medical N.V. and Acutus Medical UK Limited are measured using their functional currency, the Euro and British Pound Sterling, respectively, which is the currency of the primary foreign economic environment in which the subsidiaries operate. Upon consolidating these entities with the Company, their assets and liabilities are translated to U.S. dollars at currency exchange rates as of the balance sheet date and their revenues and expenses are translated at the weighted average currency exchange rates during the applicable reporting periods. Translation adjustments resulting from the process of translating the entities’ financial statements are reported in accumulated other comprehensive loss in the condensed consolidated balance sheets and foreign currency translation adjustment in the condensed consolidated statements of operations and comprehensive loss. |
Lease Property | Lease Property The Company leases office space in Carlsbad, California as its corporate headquarters and for manufacturing operations. Additionally, it leases office space in Zaventem, Belgium for international operations. The Company accounts for its lease property under ASC 842. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases, and are recorded on the condensed consolidated balance sheets as both a right-of-use asset and a lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate, which is the rate for collateralized borrowings based on the current economic environment, credit history, credit rating, value of leases, currency in which the lease obligation is satisfied, rate sensitivity, lease term and materiality . Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset results in straight-line rent expense over the lease term. Variable lease expenses are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elected to combine lease and non-lease components. The Company adopted the policy election to exclude short-term leases having initial terms of twelve months from the initial recognition provisions of ASC 842. See Note 11 - Operating Leases for additional details. |
Cost of Products Sold | Cost of Products Sold Cost of products sold includes raw materials, direct labor, manufacturing overhead, shipping and receiving costs and other less significant indirect costs related to the production of the Company’s products. |
Research and Development | Research and Development Prior to the Restructuring, the Company was actively engaged in new product research and development efforts. Research and development expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel directly engaged in research and development activities, clinical trial expenses, equipment costs, material costs, allocated rent and facilities costs and depreciation. Research and development expenses relating to possible future products are expensed as incurred. The Company also accrues and expenses costs for activities associated with clinical trials performed by third parties as incurred. All other costs relative to setting up clinical trial sites are expensed as incurred. Clinical trial site costs related to patient enrollment are accrued as patients are entered into the trials. |
Selling, General and Administrative | Selling, General and Administrative Selling, general, and administrative expenses consist primarily of salaries and employee-related costs (including stock-based compensation) for personnel in sales, executive, finance and other administrative functions, allocated rent and facilities costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services, marketing costs and insurance costs. |
Fair Value Measurements | Fair Value Measurements Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy is used in determining the inputs for measuring fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Observable inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3—Unobservable inputs which are supported by little or no market activity and consist of financial instruments valued using pricing models, discounted cash flow methodologies or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Management’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that the Company or holders of the instruments could realize in a current market exchange. There were no transfers made among the three levels in the fair value hierarchy for the three and nine months ended September 30, 2023 and 2022. As of September 30, 2023 and December 31, 2022, the Company’s cash (excluding cash equivalents which are recorded at fair value on a recurring basis), restricted cash, accounts receivable, accounts payable and accrued expenses were carried at cost, which approximates the fair values due to the short-term nature of each instrument. The carrying amount of the Company’s long-term debt approximates fair value due to its variable market interest rate and management’s opinion that current rates and terms that would be available to the Company with the same maturity and security structure would be essentially equivalent to that of the Company’s long-term debt. The fair value of the Company’s money market securities is determined using quoted market prices in active markets for identical assets. The fair value for the available-for-sale marketable securities is determined based on valuation models using inputs that are observable either directly or indirectly (Level 2 inputs) such as quoted prices for similar assets, yield curve, volatility factors, |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for all stock-based payments to employees and non-employees, including grants of stock options, restricted stock units ("RSUs"), and restricted stock awards ("RSAs"), to be recognized in the consolidated financial statements based on their respective grant date fair values. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The RSUs and RSAs are valued based on the fair value of the Company’s common stock on the date of grant. The Company expenses stock-based compensation related to stock options, RSUs and RSAs over the requisite service period. All stock-based compensation costs are recorded in cost of products sold, research and development expense or SG&A expense in the condensed consolidated statements of operations and comprehensive loss based upon the respective employee’s or non-employee’s roles within the Company. Forfeitures are recorded as they occur. See Note 15—Stock-Based Compensation for additional details. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse, and net operating loss (“NOL”) carryforwards and research and development tax credit carryforwards. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Warrant Liability | Warrant Liability The Company accounts for certain common stock warrants outstanding as a liability at fair value, determined using the Black-Scholes option pricing model, on the condensed consolidated balance sheets in accordance with ASC 815, Derivatives and Hedging (“ASC 815”). The liability is subject to re-measurement at each reporting period and any change in fair value is recognized in the condensed consolidated statements of operations and comprehensive loss. See Note 13—Warrants for additional details. |
Business Combinations | Business Combinations The Company accounts for business acquisitions using the acquisition method of accounting based on ASC 805, Business Combinations |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326) ("ASU 2016-13"). ASU 2016-13 sets forth a “current expected credit loss” model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost, available-for-sale debt securities and applies to certain off-balance sheet credit exposures. ASU 2016-13 is effective for smaller reporting companies in 2023. The Company adopted the guidance in the first quarter of 2023 with no material impact on the condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Cash and Cash Equivalents and Restricted Cash | The following table reconciles cash, cash equivalents and restricted cash in the condensed consolidated balance sheets to the total balances as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Cash and cash equivalents $ 24,100 $ 25,584 Restricted cash 7,015 5,764 Total cash, cash equivalents and restricted cash $ 31,115 $ 31,348 |
Summary of Cash and Cash Equivalents and Restricted Cash | The following table reconciles cash, cash equivalents and restricted cash in the condensed consolidated balance sheets to the total balances as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Cash and cash equivalents $ 24,100 $ 25,584 Restricted cash 7,015 5,764 Total cash, cash equivalents and restricted cash $ 31,115 $ 31,348 |
Summary of Disaggregation of Revenue | The following table sets forth the Company’s revenue for disposables, systems and service/other for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Disposables $ 4,069 $ 2,857 $ 11,409 $ 9,402 Systems 563 476 1,254 823 Service/Other 606 311 2,033 1,176 Total revenue $ 5,238 $ 3,644 $ 14,696 $ 11,401 |
Summary of Revenue from External Customers by Geographic Areas | The following table provides revenue by geographic location for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) United States $ 3,347 $ 1,925 $ 8,720 $ 5,985 Outside the United States 1,891 1,719 5,976 5,416 Total revenue $ 5,238 $ 3,644 $ 14,696 $ 11,401 |
Schedule of Accounts, Notes, Loans and Financing Receivable | Accounts receivable recorded on the condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022 consists of the following (in thousands): September 30, December 31, (unaudited) Trade accounts receivable $ 2,841 $ 4,085 Earnouts receivable from Medtronic 6,111 17,000 Total accounts receivable $ 8,952 $ 21,085 |
Summary of Fair Value, Liabilities Measured on Recurring Basis | The following tables classify the Company’s financial assets and liabilities measured at fair value on a recurring basis into the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands): Fair Value Measurements as of September 30, 2023 (unaudited) Quoted Significant Significant Total Assets included in: Cash and cash equivalents Money market securities $ 21,019 $ — $ — $ 21,019 Marketable securities at fair value U.S. treasury securities — 2,968 — 2,968 Commercial paper — 10,665 — 10,665 Asset-backed securities — 742 — 742 Total fair value $ 21,019 $ 14,375 $ — $ 35,394 Liabilities included in: Warrant liability $ — $ — $ 1,868 $ 1,868 Total fair value $ — $ — $ 1,868 $ 1,868 Fair Value Measurements as of December 31, 2022 Quoted Significant Significant Total Assets included in: Cash and cash equivalents Money market securities $ 22,700 $ — $ — $ 22,700 Marketable securities at fair value U.S. treasury securities — 26,897 — 26,897 Commercial paper — 14,764 — 14,764 Yankee debt securities — 3,202 — 3,202 Total fair value $ 22,700 $ 44,863 $ — $ 67,563 Liabilities included in: Warrant liability $ — $ — $ 3,346 $ 3,346 Contingent consideration — — 1,800 1,800 Total fair value $ — $ — $ 5,146 $ 5,146 |
Summary of Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table presents changes in Level 3 liabilities measured at fair value for the nine months ended September 30, 2023 (in thousands): Contingent Warrant Liability Balance, December 31, 2022 $ 1,800 $ 3,346 Change in fair value 123 (1,478) Final payment of contingent consideration $ (1,923) $ — Balance, September 30, 2023 (unaudited) $ — $ 1,868 |
Weighted-Average Unobservable Inputs to Measure Warranty Liability | The fair value was estimated to be $0.4942 per warrant as of September 30, 2023 and the significant inputs used in the estimation of the fair value were as follows: September 30, 2023 (unaudited) Risk-free interest rate 4.61% Expected term in years 6.75 Expected volatility 85.0% As of September 30, 2023 and December 31, 2022, the outstanding warrants to purchase the Company’s common stock consisted of the following: Exercise Price Expiration Date September 30, December 31, (unaudited) Warrants issued in 2015 $ 5.25 1/30/25 3,808 3,808 Warrants issued with 2018 Convertible Notes $ 0.10 6/7/28 346,689 346,689 Warrants issued with 2018 Term Loan $ 16.67 7/31/28 26,998 26,998 Warrants issued with 2019 Credit Agreement $ 16.67 5/20/29 419,992 419,992 Warrants issued with 2022 Credit Agreement $ 1.11 6/30/30 3,779,018 3,779,018 Total Warrants 4,576,505 4,576,505 |
Sale of Business (Tables)
Sale of Business (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Summary of Sale of Discontinued Operation | The Company recorded the following amounts for the nine months ended September 30, 2023, resulting in a net gain of $5.9 million related to the sale of business to Medtronic, calculated as the difference between the non-contingent consideration earned, less direct transaction costs (in thousands): Nine Months Ended (unaudited) Percentage of Product Net Sales Earnout accrued as of September 30, 2023 $ 6,111 Transaction costs (184) Gain on sale of business, net $ 5,927 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | Marketable securities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 (unaudited) Amortized Gross Gross Fair Value Available-for-sale securities - short-term: U.S. treasury securities $ 2,968 $ — $ — $ 2,968 Commercial paper 10,665 — — 10,665 Asset-backed securities 742 — — 742 Total available-for-sale securities - short-term 14,375 — — 14,375 Total available-for-sale securities $ 14,375 $ — $ — $ 14,375 December 31, 2022 Amortized Gross Gross Fair Value Available-for-sale securities - short-term: U.S. treasury securities $ 26,906 $ 3 $ (12) $ 26,897 Commercial paper 3,200 2 — 3,202 Yankee debt securities 14,764 — — 14,764 Total available-for-sale securities - short-term 44,870 5 (12) 44,863 Total available-for-sale securities $ 44,870 $ 5 $ (12) $ 44,863 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of Inventory | Inventory as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, December 31, (unaudited) Raw materials $ 10,664 $ 9,179 Work in process 2,416 2,025 Finished goods 2,648 2,123 Total inventory $ 15,728 $ 13,327 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, Net | The Company’s property and equipment, net, consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Medical diagnostic equipment $ 14,995 $ 14,826 Furniture and fixtures 452 432 Office equipment 1,561 1,556 Laboratory equipment and software 5,226 5,148 Leasehold improvements 974 580 Construction in process 1,675 2,166 Total property and equipment 24,883 24,708 Less: accumulated depreciation (18,272) (15,487) Property and equipment, net $ 6,611 $ 9,221 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets Activities | The following table presents intangible assets activity for the nine months ended September 30, 2023 (in thousands): Intangible Balance, December 31, 2022 $ 1,583 Amortization expense (150) Balance, September 30, 2023 (unaudited) $ 1,433 |
Summary of Finite Lived Intangible Assets | The tables below present the details of intangible assets as of September 30, 2023 and December 31, 2022 (dollars in thousands): September 30, 2023 Estimated Weighted Intangible Accumulated Balance (unaudited) Licensed intangibles 10.0 7.2 $ 2,000 $ (567) $ 1,433 Total intangible assets $ 2,000 $ (567) $ 1,433 December 31, 2022 Estimated Weighted Intangible Accumulated Balance Licensed intangibles 10.0 7.9 2,000 (417) 1,583 Total intangible assets $ 2,000 $ (417) $ 1,583 |
Summary of Remaining Amortization Expense | The following table presents the future amortization expense associated with amortizable intangible assets as of September 30, 2023 (in thousands): Total Three months ending December 31, 2023 $ 50 Year ending December 31, 2024 200 Year ending December 31, 2025 200 Year ending December 31, 2026 200 Year ending December 31, 2027 200 Thereafter 583 Total future amortization $ 1,433 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, December 31, (unaudited) Compensation and related expenses $ 5,264 $ 6,919 Professional fees 192 126 Deferred revenue 349 326 Sales and use tax 187 639 Clinical studies 374 390 Clinician Council payable 241 216 Accrued royalties 108 159 Accrued restructuring 35 45 Other 688 866 Total accrued liabilities $ 7,438 $ 9,686 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Outstanding Debt | Outstanding debt as of September 30, 2023 and December 31, 2022 consisted of the following (in thousands): September 30, December 31, (unaudited) 2022 Credit Agreement (1) $ 36,750 $ 36,776 Total outstanding debt, gross 36,750 36,776 Less: Unamortized debt discount and fees (1,989) (2,342) Total outstanding debt, long-term $ 34,761 $ 34,434 (1) The 2022 Credit Agreement includes final payment fees of $1.8 million. |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Summary of Quantitative Information About Operating Leases and Components of Lease Cost | The following table summarizes quantitative information about the Company’s operating leases for the nine months ended September 30, 2023 and 2022 (dollars in thousands): Nine Months Ended September 30, 2023 2022 (unaudited) Operating cash flows from operating leases $ 282 $ 631 Weighted average remaining lease term – operating leases (in years) 4.2 3.4 Weighted average discount rate – operating leases 7.0% 7.0% The following table provides the components of the Company’s operating lease expense for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Operating leases Operating lease cost $ 252 $ 252 $ 755 $ 768 Variable lease cost 81 77 243 216 Total operating lease expense $ 333 $ 329 $ 998 $ 984 |
Summary of Future Minimum Payments Under the Non-cancelable Operating Leases | As of September 30, 2023, future minimum payments under the non-cancelable operating leases under ASC 842 were as follows (in thousands): Three months ending December 31, 2023 $ 138 Year ending December 31, 2024 1,160 Year ending December 31, 2025 1,151 Year ending December 31, 2026 1,185 Year ending December 31, 2027 1,221 Total 4,855 Less: present value discount (686) Operating lease liabilities $ 4,169 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Warrants and Rights Note Disclosure [Abstract] | |
Schedule of Outstanding Warrants to Purchase the Company's Common Stock | The fair value was estimated to be $0.4942 per warrant as of September 30, 2023 and the significant inputs used in the estimation of the fair value were as follows: September 30, 2023 (unaudited) Risk-free interest rate 4.61% Expected term in years 6.75 Expected volatility 85.0% As of September 30, 2023 and December 31, 2022, the outstanding warrants to purchase the Company’s common stock consisted of the following: Exercise Price Expiration Date September 30, December 31, (unaudited) Warrants issued in 2015 $ 5.25 1/30/25 3,808 3,808 Warrants issued with 2018 Convertible Notes $ 0.10 6/7/28 346,689 346,689 Warrants issued with 2018 Term Loan $ 16.67 7/31/28 26,998 26,998 Warrants issued with 2019 Credit Agreement $ 16.67 5/20/29 419,992 419,992 Warrants issued with 2022 Credit Agreement $ 1.11 6/30/30 3,779,018 3,779,018 Total Warrants 4,576,505 4,576,505 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Estimate of the Fair Value of Stock Option | The following assumptions were used to estimate the fair value of stock options for the nine months ended September 30, 2023 and 2022: Nine Months Ended September 30, 2023 2022 (unaudited) Risk-free interest rate 3.91% - 4.27% 1.76% - 3.39% Expected dividend yield — — Expected term in years 5.5 - 5.6 5.5 - 6.0 Expected volatility 75% - 85% 75% - 90% |
Summary of Stock Option Activity | The Company's stock option activity for the nine months ended September 30, 2023 was as follows: Stock Weighted Weighted Aggregate Outstanding as of December 31, 2022 2,898,821 $ 6.83 6.9 $ 79 Options granted 755,580 1.28 Options exercised (3,218) 1.34 $ 1 Options forfeited (1,562,043) 10.72 Outstanding as of September 30, 2023 (unaudited) 2,089,140 $ 1.93 7.6 $ 23 Options vested and exercisable as of September 30, 2023 (unaudited) 1,098,279 $ 2.43 6.4 $ 23 |
Schedule of RSU Activity | The Company’s RSU activity for the nine months ended September 30, 2023 was as follows: Number Weighted Unvested as of December 31, 2022 1,659,898 $ 4.17 Granted 1,881,020 1.30 Forfeited (372,930) 4.49 Vested (877,260) 2.82 Unvested as of September 30, 2023 (unaudited) 2,290,728 $ 2.28 |
Summary of the Total Stock-Based Compensation Expense for the Stock Options, PSUs and RSAs Recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss | The following table summarizes the total stock-based compensation expense for the stock options, PSUs, RSUs, RSAs and ESPP expense recorded in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Cost of products sold $ 146 $ 93 $ 373 $ 544 Research and development 317 349 999 1,417 Selling, general and administrative 815 1,442 3,543 5,536 Total stock-based compensation $ 1,278 $ 1,884 $ 4,915 $ 7,497 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities | The table below provides potentially dilutive securities not included in the calculation of the diluted net loss per common share because to do so would be anti-dilutive: Nine Months Ended September 30, 2023 2022 (unaudited) Shares issuable upon: Conversion of Series A Common Equivalent Preferred Stock 6,665,841 6,665,841 Exercise of common stock warrants 4,576,505 4,576,505 Exercise of stock options 1,098,279 3,267,782 Vesting of RSUs and RSAs 2,290,728 1,761,181 Issuance of shares under 2020 ESPP 61,361 — Total potentially dilutive securities 14,692,714 16,271,309 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Feb. 01, 2023 | Jan. 13, 2023 | Jun. 30, 2022 | Jan. 31, 2023 | Nov. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Cash, cash equivalents, restricted cash and marketable securities | $ 45,500 | $ 45,500 | $ 76,200 | |||||||
Net loss | 13,237 | $ 20,425 | 47,898 | $ 54,724 | ||||||
Net cash used in operating activities | (45,105) | (72,053) | ||||||||
Accumulated deficit | 566,212 | 566,212 | 518,314 | |||||||
Working capital | $ 57,900 | 57,900 | $ 98,000 | |||||||
Proceeds from sale of business | 17,000 | $ 50,000 | ||||||||
Left-Heart Access Portfolio | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Contingent consideration received from sales | $ 6,100 | |||||||||
Held-for-sale | Left-Heart Access Portfolio | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Proceeds from sale of business | $ 17,000 | $ 50,000 | $ 17,000 | $ 20,000 | ||||||
Indemnity escrow account, amount | $ 4,000 | $ 1,400 | $ 1,600 | |||||||
Indemnity escrow account, term | 18 months | |||||||||
Milestone consideration, period | 4 years | 4 years | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year one | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 100% | 100% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year two | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 75% | 75% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year three | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 50% | 50% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year four | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 50% | 50% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Feb. 01, 2023 | Jan. 13, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jan. 31, 2023 USD ($) | Nov. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) reporting_unit segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Number of operating segment | segment | 1 | |||||||||
Number of reportable segments | segment | 1 | |||||||||
Inventory write-down | $ 300,000 | $ 200,000 | $ 900,000 | $ 2,600,000 | ||||||
Allowance for uncollectible accounts | 0 | 0 | $ 0 | |||||||
Proceeds from sale of business | 17,000,000 | 50,000,000 | ||||||||
Employer retention credit receivable | 0 | $ 0 | $ 4,703,000 | |||||||
Number of reporting unit | reporting_unit | 1 | |||||||||
Goodwill impairment | 0 | 0 | $ 0 | 12,026,000 | ||||||
Impairment of property and equipment | 0 | 0 | 0 | 0 | ||||||
Impairment of intangible assets | 0 | $ 0 | 0 | $ 0 | ||||||
Left-Heart Access Portfolio | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Contingent consideration received from sales | 6,100,000 | |||||||||
Held-for-sale | Left-Heart Access Portfolio | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Proceeds from sale of business | $ 17,000,000 | $ 50,000,000 | $ 17,000,000 | $ 20,000,000 | ||||||
Milestone consideration, period | 4 years | 4 years | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year one | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 100% | 100% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year two | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 75% | 75% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year three | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 50% | 50% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Year four | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Milestone consideration, royalty percentage | 50% | 50% | ||||||||
Held-for-sale | Left-Heart Access Portfolio | Transfer Earnout | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Proceeds from sale of business | $ 17,000,000 | |||||||||
CARES Employee Retention Credit | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Employer retention credit, amount refunded | 6,800,000 | 6,800,000 | ||||||||
Employer retention credit receivable | $ 4,700,000 | $ 4,700,000 | ||||||||
Minimum | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Customers payment period | 30 days | |||||||||
Property and equipment, estimated useful lives | 3 years | 3 years | ||||||||
Maximum | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Customers payment period | 60 days | |||||||||
Contracts with customers, expected duration | 1 year | 1 year | ||||||||
Agreement to produce and sell products, term | 4 years | |||||||||
Property and equipment, estimated useful lives | 5 years | 5 years | ||||||||
Deferred Equipment Agreements | Minimum | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Term of contract | 2 years | |||||||||
Deferred Equipment Agreements | Maximum | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Term of contract | 4 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 24,100 | $ 25,584 | ||
Restricted Cash | 7,015 | 5,764 | ||
Total cash, cash equivalents and restricted cash | $ 31,115 | $ 31,348 | $ 32,153 | $ 24,221 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Disaggregation of Revenue (Details) - 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 revenue | $ 5,238 | $ 3,644 | $ 14,696 | $ 11,401 |
Disposables | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 4,069 | 2,857 | 11,409 | 9,402 |
Systems | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 563 | 476 | 1,254 | 823 |
Service/Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 606 | $ 311 | $ 2,033 | $ 1,176 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Revenue from External Customers by Geographic Areas (Details) - 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 revenue | $ 5,238 | $ 3,644 | $ 14,696 | $ 11,401 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 3,347 | 1,925 | 8,720 | 5,985 |
Outside the United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 1,891 | $ 1,719 | $ 5,976 | $ 5,416 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Accounts Receivable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 8,952 | $ 21,085 |
Trade accounts receivable | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | 2,841 | 4,085 |
Earnouts receivable from Medtronic | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 6,111 | $ 17,000 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Fair Value, Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets included in: | ||
Available-for-sale securities | $ 14,375 | $ 44,863 |
Total fair value | 35,394 | 67,563 |
Liabilities included in: | ||
Total fair value | 1,868 | 5,146 |
Warrant liability | ||
Liabilities included in: | ||
Total fair value | 1,868 | 3,346 |
Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 1,800 | |
Money market securities | ||
Assets included in: | ||
Money market securities | 21,019 | 22,700 |
U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 2,968 | 26,897 |
Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 10,665 | 14,764 |
Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | 742 | |
Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 3,202 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets included in: | ||
Total fair value | 21,019 | 22,700 |
Liabilities included in: | ||
Total fair value | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Warrant liability | ||
Liabilities included in: | ||
Total fair value | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 0 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market securities | ||
Assets included in: | ||
Money market securities | 21,019 | 22,700 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Assets included in: | ||
Total fair value | 14,375 | 44,863 |
Liabilities included in: | ||
Total fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Warrant liability | ||
Liabilities included in: | ||
Total fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 0 | |
Significant Other Observable Inputs (Level 2) | Money market securities | ||
Assets included in: | ||
Money market securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 2,968 | 26,897 |
Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 10,665 | 14,764 |
Significant Other Observable Inputs (Level 2) | Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | 742 | |
Significant Other Observable Inputs (Level 2) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 3,202 | |
Significant Unobservable Inputs (Level 3) | ||
Assets included in: | ||
Total fair value | 0 | 0 |
Liabilities included in: | ||
Total fair value | 1,868 | 5,146 |
Significant Unobservable Inputs (Level 3) | Warrant liability | ||
Liabilities included in: | ||
Total fair value | 1,868 | 3,346 |
Significant Unobservable Inputs (Level 3) | Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 1,800 | |
Significant Unobservable Inputs (Level 3) | Money market securities | ||
Assets included in: | ||
Money market securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | $ 0 | |
Significant Unobservable Inputs (Level 3) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | $ 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Contingent Consideration | ||||
Change in fair value | $ 0 | $ 198 | $ 123 | $ 1,153 |
Significant Unobservable Inputs (Level 3) | Contingent consideration | ||||
Contingent Consideration | ||||
Balance at beginning of period | 1,800 | |||
Change in fair value | 123 | |||
Final payment of contingent consideration | (1,923) | |||
Balance at end of period (unaudited) | 0 | 0 | ||
Significant Unobservable Inputs (Level 3) | Warrant liability | ||||
Contingent Consideration | ||||
Balance at beginning of period | 3,346 | |||
Change in fair value | (1,478) | |||
Final payment of contingent consideration | 0 | |||
Balance at end of period (unaudited) | $ 1,868 | $ 1,868 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Weighted-Average Unobservable Inputs to Measure Warranty Liability (Details) - Significant Unobservable Inputs (Level 3) - Exercise of common stock warrants | Sep. 30, 2023 year $ / shares |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Share price (in usd per share) | $ / shares | $ 0.4942 |
Risk-free interest rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | 0.0461 |
Expected term in years | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | year | 6.75 |
Expected volatility | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrants and rights outstanding, measurement input | 0.850 |
Sale of Business - Narrative (D
Sale of Business - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Feb. 01, 2023 | Jan. 13, 2023 | Jun. 30, 2022 | Jan. 31, 2023 | Nov. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Proceeds from sale of business | $ 17,000 | $ 50,000 | ||||||
Held-for-sale | Left-Heart Access Portfolio | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Proceeds from sale of business | $ 17,000 | $ 50,000 | $ 17,000 | $ 20,000 | ||||
Indemnity escrow account, amount | $ 4,000 | $ 1,400 | $ 1,600 | |||||
Indemnity escrow account, term | 18 months | |||||||
Milestone consideration, period | 4 years | 4 years | ||||||
Held-for-sale | Left-Heart Access Portfolio | OEM Earnout | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Proceeds from sale of business | $ 20,000 | |||||||
Held-for-sale | Left-Heart Access Portfolio | Transfer Earnout | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Proceeds from sale of business | $ 17,000 | |||||||
Held-for-sale | Left-Heart Access Portfolio | Medtronic | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Earnout accrued | 6,111 | |||||||
Gain on sale of business, net | $ 5,927 | $ 79,500 | ||||||
Held-for-sale | Left-Heart Access Portfolio | Year one | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Milestone consideration, royalty percentage | 100% | 100% | ||||||
Held-for-sale | Left-Heart Access Portfolio | Year two | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Milestone consideration, royalty percentage | 75% | 75% | ||||||
Held-for-sale | Left-Heart Access Portfolio | Year three | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Milestone consideration, royalty percentage | 50% | 50% | ||||||
Held-for-sale | Left-Heart Access Portfolio | Year four | ||||||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||||||
Milestone consideration, royalty percentage | 50% | 50% |
Sale of Business - Summary of S
Sale of Business - Summary of Sale of Discontinued Operation (Details) - Held-for-sale - Left-Heart Access Portfolio - Medtronic - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Percentage of Product Net Sales Earnout accrued as of September 30, 2023 | $ 6,111 | |
Transaction costs | (184) | |
Gain on sale of business, net | $ 5,927 | $ 79,500 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Available-for-sale securities - short-term: | ||
Amortized Cost | $ 14,375 | $ 44,870 |
Gross Unrealized Gains | 0 | 5 |
Gross Unrealized Losses | 0 | (12) |
Fair Value | 14,375 | 44,863 |
Total available-for-sale securities | ||
Amortized Cost | 14,375 | 44,870 |
Gross Unrealized Gains | 0 | 5 |
Gross Unrealized Losses | 0 | (12) |
Fair Value | 14,375 | 44,863 |
U.S. treasury securities | ||
Available-for-sale securities - short-term: | ||
Amortized Cost | 2,968 | 26,906 |
Gross Unrealized Gains | 0 | 3 |
Gross Unrealized Losses | 0 | (12) |
Fair Value | 2,968 | 26,897 |
Commercial paper | ||
Available-for-sale securities - short-term: | ||
Amortized Cost | 10,665 | 3,200 |
Gross Unrealized Gains | 0 | 2 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 10,665 | 3,202 |
Asset-backed securities | ||
Available-for-sale securities - short-term: | ||
Amortized Cost | 742 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 742 | |
Yankee debt securities | ||
Available-for-sale securities - short-term: | ||
Amortized Cost | 14,764 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 14,764 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] | ||
Fair Value | $ 14,375,000 | $ 44,863,000 |
Marketable securities, short-term, maturity | 1 year | 1 year |
Marketable securities, long-term | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 10,664 | $ 9,179 |
Work in process | 2,416 | 2,025 |
Finished goods | 2,648 | 2,123 |
Total inventory | $ 15,728 | $ 13,327 |
Lessor Sales-Type Leases - Narr
Lessor Sales-Type Leases - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Lessor, Lease, Description [Line Items] | |||||
Lease revenue | $ 0 | $ 0 | $ 500,000 | $ 300,000 | |
Prepaid Expenses and Other Current Assets | |||||
Lessor, Lease, Description [Line Items] | |||||
Lease receivable | 600,000 | 600,000 | $ 600,000 | ||
Other Assets | |||||
Lessor, Lease, Description [Line Items] | |||||
Lease receivable | $ 300,000 | $ 300,000 | $ 500,000 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 24,883 | $ 24,708 |
Less: accumulated depreciation | (18,272) | (15,487) |
Property and equipment, net | 6,611 | 9,221 |
Medical diagnostic equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 14,995 | 14,826 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 452 | 432 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,561 | 1,556 |
Laboratory equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 5,226 | 5,148 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 974 | 580 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,675 | $ 2,166 |
Property and Equipment, Net - N
Property and Equipment, Net - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 1,000 | $ 1,500 | $ 3,498 | $ 4,653 |
Intangible Assets - Summary of
Intangible Assets - Summary of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Intangible Assets | ||||
Balance at beginning of period | $ 1,583 | |||
Amortization expense | $ (100) | $ (100) | (150) | $ (370) |
Balance at end of period (unaudited) | $ 1,433 | $ 1,433 |
Intangible Assets - Summary o_2
Intangible Assets - Summary of Finite and Indefinite Lived Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets | $ 2,000 | $ 2,000 |
Accumulated Amortization | (567) | (417) |
Finite-lived intangible assets, net | $ 1,433 | $ 1,583 |
Licensed intangibles | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Weighted Average Remaining Life | 7 years 2 months 12 days | 7 years 10 months 24 days |
Intangible Assets | $ 2,000 | $ 2,000 |
Accumulated Amortization | (567) | (417) |
Finite-lived intangible assets, net | $ 1,433 | $ 1,583 |
Intangible Assets - Narrative (
Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Amortization of intangible assets | $ 100 | $ 100 | $ 150 | $ 370 |
Intangible Assets - Summary o_3
Intangible Assets - Summary of Remaining Amortization Expense (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Three months ending December 31, 2023 | $ 50 | |
Year ending December 31, 2024 | 200 | |
Year ending December 31, 2025 | 200 | |
Year ending December 31, 2026 | 200 | |
Year ending December 31, 2027 | 200 | |
Thereafter | 583 | |
Finite-lived intangible assets, net | $ 1,433 | $ 1,583 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Compensation and related expenses | $ 5,264 | $ 6,919 |
Professional fees | 192 | 126 |
Deferred revenue | 349 | 326 |
Sales and use tax | 187 | 639 |
Clinical studies | 374 | 390 |
Clinician Council payable | 241 | 216 |
Accrued royalties | 108 | 159 |
Accrued restructuring | 35 | 45 |
Other | 688 | 866 |
Total accrued liabilities | $ 7,438 | $ 9,686 |
Debt - Summary of Outstanding D
Debt - Summary of Outstanding Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Aug. 04, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | |||
Long-term debt, gross | $ 36,750 | $ 36,776 | |
Less: Unamortized debt discount and fees | (1,989) | (2,342) | |
Total outstanding debt, long-term | 34,761 | 34,434 | |
2022 Credit Agreement | |||
Debt Instrument [Line Items] | |||
Long-term debt, gross | 36,750 | $ 36,776 | |
2022 Credit Agreement | Senior Term Loan | |||
Debt Instrument [Line Items] | |||
Fee amount | $ 1,800 | $ 1,800 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | Aug. 04, 2023 | Jun. 30, 2022 | Nov. 08, 2023 | Sep. 30, 2023 |
Exercise of common stock warrants | ||||
Debt Instrument [Line Items] | ||||
Class of warrants number of securities called by the warrants or rights (in shares) | 3,779,018 | |||
Class of warrants, exercise price (in dollars per share) | $ 1.1114 | |||
Warrant, term | 8 years | |||
Deerfield Credit Agreement, Amendment 1 | Subsequent Event | ||||
Debt Instrument [Line Items] | ||||
Minimum liquidity covenant | $ 10,000,000 | |||
Term 1 | Deerfield Credit Agreement, Amendment 1 | ||||
Debt Instrument [Line Items] | ||||
Minimum liquidity covenant | $ 5,000,000 | |||
Minimum liquidity covenant, term | 18 months | |||
Term 2 | Deerfield Credit Agreement, Amendment 1 | ||||
Debt Instrument [Line Items] | ||||
Minimum liquidity covenant | $ 20,000,000 | |||
Term 3 | Deerfield Credit Agreement, Amendment 1 | ||||
Debt Instrument [Line Items] | ||||
Minimum liquidity covenant | 10,000,000 | |||
2022 Credit Agreement | Senior Term Loan | ||||
Debt Instrument [Line Items] | ||||
Face amount | $ 35,000,000 | |||
Debt instrument, term | 5 years | |||
Fee amount | $ 1,800,000 | $ 1,800,000 | ||
2022 Credit Agreement | Senior Term Loan | End of Month 36 | ||||
Debt Instrument [Line Items] | ||||
Periodic payment, percentage of principal | 15% | |||
2022 Credit Agreement | Senior Term Loan | End of Month 48 | ||||
Debt Instrument [Line Items] | ||||
Periodic payment, percentage of principal | 15% | |||
2022 Credit Agreement | Senior Term Loan | End of Month 60 | ||||
Debt Instrument [Line Items] | ||||
Periodic payment, percentage of principal | 70% | |||
2022 Credit Agreement | Senior Term Loan | SOFR | ||||
Debt Instrument [Line Items] | ||||
Variable rate | 9% | |||
Variable rate, floor | 2.50% |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Sep. 30, 2023 ft² |
Corporate Office Space and Manufacturing Facility | |
Lessee, Lease, Description [Line Items] | |
Office space | 50,800 |
Operating lease, renewal term | 5 years |
Office Space Zaventem Belgium | |
Lessee, Lease, Description [Line Items] | |
Office space | 3,900 |
Operating Leases - Summary of Q
Operating Leases - Summary of Quantitative Information About Operating Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Operating cash flows from operating leases | $ 282 | $ 631 |
Weighted average remaining lease term – operating leases | 4 years 2 months 12 days | 3 years 4 months 24 days |
Weighted average discount rate – operating leases | 7% | 7% |
Operating Leases - Summary of C
Operating Leases - Summary of Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating leases | ||||
Operating lease cost | $ 252 | $ 252 | $ 755 | $ 768 |
Variable lease cost | 81 | 77 | 243 | 216 |
Total operating lease expense | $ 333 | $ 329 | $ 998 | $ 984 |
Operating Leases - Summary of F
Operating Leases - Summary of Future Minimum Payments Under the Non-Cancelable Operating Leases (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
Three months ending December 31, 2023 | $ 138 |
Year ending December 31, 2024 | 1,160 |
Year ending December 31, 2025 | 1,151 |
Year ending December 31, 2026 | 1,185 |
Year ending December 31, 2027 | 1,221 |
Total | 4,855 |
Less: present value discount | (686) |
Operating lease liabilities | $ 4,169 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - lawsuit | Jul. 19, 2022 | Feb. 14, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Number of class action lawsuits | 2 | |
Number of class action lawsuits consolidated | 2 |
Warrants - Schedule of Outstand
Warrants - Schedule of Outstanding Warrants to Purchase the Company's Common Stock (Details) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Warrant or Right [Line Items] | ||
Warrants outstanding (in shares) | 4,576,505 | 4,576,505 |
Common Stock | Warrants issued in 2015 | ||
Class of Warrant or Right [Line Items] | ||
Exercise price (in dollars per share) | $ 5.25 | |
Warrants outstanding (in shares) | 3,808 | 3,808 |
Common Stock | Warrants issued with 2018 Convertible Notes | ||
Class of Warrant or Right [Line Items] | ||
Exercise price (in dollars per share) | $ 0.10 | |
Warrants outstanding (in shares) | 346,689 | 346,689 |
Common Stock | Warrants issued with 2018 Term Loan | ||
Class of Warrant or Right [Line Items] | ||
Exercise price (in dollars per share) | $ 16.67 | |
Warrants outstanding (in shares) | 26,998 | 26,998 |
Common Stock | Warrants issued with 2019 Credit Agreement | ||
Class of Warrant or Right [Line Items] | ||
Exercise price (in dollars per share) | $ 16.67 | |
Warrants outstanding (in shares) | 419,992 | 419,992 |
Common Stock | Warrants issued with 2022 Credit Agreement | ||
Class of Warrant or Right [Line Items] | ||
Exercise price (in dollars per share) | $ 1.11 | |
Warrants outstanding (in shares) | 3,779,018 | 3,779,018 |
Warrants - Narrative (Details)
Warrants - Narrative (Details) $ in Millions | 1 Months Ended | 9 Months Ended |
Aug. 31, 2021 | Sep. 30, 2023 USD ($) holder | |
Warrants and Rights Note Disclosure [Abstract] | ||
Favorable change in fair value of warrants | $ | $ 1.5 | |
Number of warrant holders | 4 | |
Maximum percentage of outstanding common stock | 0.049 | 0.049 |
Number of warrant holders with ability to increase stock ownership percentage after written notice election | 2 | |
Maximum percentage of outstanding common stock, notice for increase | 0.099 | 0.099 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Aug. 31, 2021 investor $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 $ / shares | |
Class of Stock [Line Items] | ||||
Number of investors | investor | 4 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Maximum percentage of outstanding common stock | 0.049 | 0.049 | ||
Common stock conversion, notice for increase, period | 61 days | |||
Maximum percentage of outstanding common stock, notice for increase | 0.099 | 0.099 | ||
Stock option exercises (in shares) | 3,218 | |||
Proceeds from the exercise of stock options | $ | $ 4 | $ 66 | ||
Employee stock purchase plan shares issued | $ | $ 25 | $ 182 | ||
Common Stock | ||||
Class of Stock [Line Items] | ||||
Conversion of stock, shares converted (in shares) | 6,665,841 | |||
Stock option exercises (in shares) | 3,218 | 98,772 | ||
Proceeds from the exercise of stock options | $ | $ 100 | |||
Employee stock purchase plan shares issued (in shares) | 45,162 | 94,226 | ||
Employee stock purchase plan shares issued | $ | $ 100 | $ 200 | ||
Common Stock | Restricted Stock Units (RSUs) | ||||
Class of Stock [Line Items] | ||||
Restricted share award shares issued (in shares) | 686,898 | 223,567 | ||
Common Stock | Maximum | ||||
Class of Stock [Line Items] | ||||
Proceeds from the exercise of stock options | $ | $ 100 | |||
Series A Preferred Stock | ||||
Class of Stock [Line Items] | ||||
Conversion of stock, shares issued (in shares) | 6,666 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | |||
Conversion of stock, option to convert to common stock (in shares) | 1,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended | |||
Jan. 01, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Aug. 05, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Expected dividend yield | 0% | 0% | |||
Fair value exercise price to calculate aggregate intrinsic value of options (in dollars per share) | $ 0.70 | $ 1.15 | |||
Share based compensation by share based payment arrangement weighted-average grant date fair value per share of stock option grants (in dollars per share) | $ 0.87 | ||||
Unrecognized compensation related to stock options not vested | $ 2.3 | ||||
Share based compensation non vested award period for recognition | 1 year 3 months 18 days | ||||
Restricted Stock Units (RSUs) | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based compensation non vested award period for recognition | 1 year 7 months 6 days | ||||
Unrecognized compensation related to restricted stock not vested | $ 3.7 | ||||
2022 Plan | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 6,000,000 | ||||
Share based payment arrangement number of shares available for issuance (in shares) | 5,715,233 | ||||
2020 Plan | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 5,573,491 | ||||
Share based payment arrangement number of shares available for issuance (in shares) | 2,880,276 | ||||
Share based compensation by share based payments arrangement, number of additional shares authorized (in shares) | 1,142,186 | ||||
2011 Plan | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 263,571 | ||||
Share based payment arrangement number of shares available for issuance (in shares) | 0 | ||||
Share based compensation by share based payments arrangement, remain available for issuance (in shares) | 0 | ||||
Share based compensation by share based payment arrangement stock options vesting term | 4 years | ||||
Share based compensation by share based payment arrangement stock options contractual term | 10 years | ||||
2020 ESPP | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 252,042 | 645,105 | |||
Number of shares available for purchase (in shares) | 669,017 | ||||
2020 ESPP | Maximum | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Participants purchase price of common stock | 85% |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Estimate of the Fair Value of Stock Option (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.91% | 1.76% |
Risk-free interest rate, maximum | 4.27% | 3.39% |
Expected dividend yield | 0% | 0% |
Expected volatility, minimum | 75% | 75% |
Expected volatility, maximum | 85% | 90% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years 6 months | 5 years 6 months |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years 7 months 6 days | 6 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stock Options | ||
Outstanding at beginning of period (in shares) | 2,898,821 | |
Options granted (in shares) | 755,580 | |
Options exercised (in shares) | (3,218) | |
Options forfeited (in shares) | (1,562,043) | |
Outstanding at end of period (unaudited) (in shares) | 2,089,140 | 2,898,821 |
Options vested and exercisable at end of period (unaudited) (in shares) | 1,098,279 | |
Weighted Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 6.83 | |
Options granted (in dollars per share) | 1.28 | |
Options exercised (in dollars per share) | 1.34 | |
Options forfeited (in dollars per share) | 10.72 | |
Outstanding at end of period (unaudited) (in dollars per share) | 1.93 | $ 6.83 |
Options vested and exercisable at end of period (unaudited) (in dollars per share) | $ 2.43 | |
Stock Options Activity, Additional Disclosures | ||
Weighted average remaining contractual life, Outstanding | 7 years 7 months 6 days | 6 years 10 months 24 days |
Weighted average remaining contractual life, Options vested and exercisable at end of period (unaudited) | 6 years 4 months 24 days | |
Aggregate intrinsic value, Outstanding balance at beginning of period | $ 79 | |
Aggregate intrinsic value, Options exercised | 1 | |
Aggregate intrinsic value, Outstanding balance at end of period (unaudited) | 23 | $ 79 |
Aggregate intrinsic value, Options vested and exercisable at end of period (unaudited) | $ 23 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of RSU Activity (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of Shares | |
Unvested balance at beginning of period (in shares) | shares | 1,659,898 |
Granted (in shares) | shares | 1,881,020 |
Forfeited (in shares) | shares | (372,930) |
Vested (in shares) | shares | (877,260) |
Unvested balance at end of period (unaudited) (in shares) | shares | 2,290,728 |
Weighted Average Grant Price | |
Unvested balance at beginning of period (in dollars per share) | $ / shares | $ 4.17 |
Granted (in dollars per share) | $ / shares | 1.30 |
Forfeited (in dollars per share) | $ / shares | 4.49 |
Vested (in dollars per share) | $ / shares | 2.82 |
Unvested balance at end of period (unaudited) (in dollars per share) | $ / shares | $ 2.28 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of the Total Stock-Based Compensation Expense for the Stock Options, PSUs and RSAs Recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 1,278 | $ 1,884 | $ 4,915 | $ 7,497 |
Cost of products sold | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 146 | 93 | 373 | 544 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 317 | 349 | 999 | 1,417 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 815 | $ 1,442 | $ 3,543 | $ 5,536 |
Net Loss Per Common Share - Sch
Net Loss Per Common Share - Schedule of Antidilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 14,692,714 | 16,271,309 |
Conversion of Series A Common Equivalent Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 6,665,841 | 6,665,841 |
Exercise of common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 4,576,505 | 4,576,505 |
Exercise of stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 1,098,279 | 3,267,782 |
Vesting of RSUs and RSAs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 2,290,728 | 1,761,181 |
Issuance of shares under 2020 ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 61,361 | 0 |
401(k) Retirement Plan (Details
401(k) Retirement Plan (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
401(k) Retirement Plan | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Employer contribution to defined benefit plan | $ 0 | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 04, 2023 | May 20, 2019 | |
Related Party Transaction [Line Items] | |||||||||
Interest expense | $ 1,409 | $ 1,109 | $ 4,110 | $ 3,810 | |||||
Common stock, shares issued (in shares) | 29,289,934 | 29,289,934 | 28,554,656 | ||||||
Piggy-back registration rights, period | 5 years | ||||||||
Warrant liability | |||||||||
Related Party Transaction [Line Items] | |||||||||
Class of warrants, exercise price (in dollars per share) | $ 1.1114 | ||||||||
Warrant, term | 8 years | ||||||||
2022 Credit Agreement | Senior Term Loan | |||||||||
Related Party Transaction [Line Items] | |||||||||
Face amount | $ 35,000 | ||||||||
Consulting Agreement | Board of Directors Chairman | |||||||||
Related Party Transaction [Line Items] | |||||||||
Consulting fees incurred for related party, less than | $ 100 | $ 100 | $ 100 | $ 200 | |||||
Credit Agreements | Related Party | 2019 and 2022 Credit Agreement | |||||||||
Related Party Transaction [Line Items] | |||||||||
Liability for loan balance | $ 34,400 | $ 40,400 | |||||||
Interest expense | $ 5,100 | $ 5,700 | |||||||
Credit Agreements | Related Party | 2019 Credit Agreement | |||||||||
Related Party Transaction [Line Items] | |||||||||
Loan balance, repaid in full | $ 40,000 | ||||||||
Credit Agreements | Related Party | 2019 Credit Agreement | Senior Term Loan | |||||||||
Related Party Transaction [Line Items] | |||||||||
Face amount | $ 70,000 | ||||||||
Credit Agreements | Related Party | 2022 Credit Agreement | Senior Term Loan | |||||||||
Related Party Transaction [Line Items] | |||||||||
Face amount | $ 35,000 | ||||||||
Long-term debt, term | 5 years | ||||||||
Warrants | Related Party | Warrant liability | |||||||||
Related Party Transaction [Line Items] | |||||||||
Common stock, shares issued (in shares) | 3,779,018 | ||||||||
Class of warrants, exercise price (in dollars per share) | $ 1.1114 | ||||||||
Warrant, term | 8 years |
Subsequent Events (Details)
Subsequent Events (Details) | Nov. 06, 2023 USD ($) employee | Nov. 08, 2023 USD ($) | Sep. 30, 2023 $ / shares | May 01, 2023 $ / shares | Dec. 31, 2022 $ / shares |
Subsequent Event [Line Items] | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Number of employees reduction in workforce | employee | 160 | ||||
Employees reduction in workforce percentage | 65% | ||||
Subsequent Event | Deerfield Credit Agreement, Amendment 1 | |||||
Subsequent Event [Line Items] | |||||
Minimum liquidity covenant | $ 10,000,000 | ||||
Subsequent Event | Minimum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | $ 21,000,000 | ||||
Subsequent Event | Maximum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 32,000,000 | ||||
Subsequent Event | Employee Severance | Minimum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 2,000,000 | ||||
Subsequent Event | Employee Severance | Maximum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 3,000,000 | ||||
Subsequent Event | Retention Bonuses | Minimum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 3,000,000 | ||||
Subsequent Event | Retention Bonuses | Maximum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 4,000,000 | ||||
Subsequent Event | Other Restructuring | Minimum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 2,000,000 | ||||
Subsequent Event | Other Restructuring | Maximum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 5,000,000 | ||||
Subsequent Event | Asset Impairment | Minimum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | 14,000,000 | ||||
Subsequent Event | Asset Impairment | Maximum | |||||
Subsequent Event [Line Items] | |||||
Estimate of pre-tax restructuring and exit-related charges | $ 20,000,000 |