Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | May 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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 $0.001 per share | |
Trading Symbol | AFIB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 28,336,285 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001522860 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 12,319 | $ 24,071 |
Marketable securities, short-term | 62,292 | 76,702 |
Restricted cash | 150 | 150 |
Accounts receivable | 2,978 | 3,633 |
Inventory | 17,620 | 16,408 |
Prepaid expenses and other current assets | 9,064 | 5,326 |
Total current assets | 104,423 | 126,290 |
Marketable securities, long-term | 4,014 | 7,120 |
Property and equipment, net | 12,962 | 13,670 |
Right-of-use assets, net | 4,358 | 4,521 |
Intangible assets, net | 4,853 | 5,013 |
Goodwill | 0 | 12,026 |
Other assets | 1,032 | 1,152 |
Total assets | 131,642 | 169,792 |
Current liabilities: | ||
Accounts payable | 4,781 | 7,519 |
Accrued liabilities | 10,632 | 9,096 |
Contingent consideration, short-term | 1,400 | 1,500 |
Operating lease liabilities, short-term | 501 | 395 |
Total current liabilities | 17,314 | 18,510 |
Operating lease liabilities, long-term | 4,471 | 4,591 |
Long-term debt | 40,793 | 40,415 |
Contingent consideration, long-term | 300 | 500 |
Other long-term liabilities | 2 | 50 |
Total liabilities | 62,880 | 64,066 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 6,666 shares of the preferred stock, designated as Series A Common Equivalent Preferred Stock, are issued and outstanding as of March 31, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 260,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 28,279,065 and 27,957,223 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 28 | 28 |
Additional paid-in capital | 587,889 | 584,613 |
Accumulated deficit | (518,715) | (478,698) |
Accumulated other comprehensive loss | (440) | (217) |
Total stockholders' equity | 68,762 | 105,726 |
Total liabilities and stockholders' equity | $ 131,642 | $ 169,792 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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) | 28,279,065 | 27,957,223 |
Common stock, shares outstanding (in shares) | 28,279,065 | 27,957,223 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Revenue | $ 3,681 | $ 3,591 |
Costs and operating expenses: | ||
Cost of products sold | 6,941 | 6,955 |
Research and development | 8,003 | 9,370 |
Selling, general and administrative | 14,385 | 16,252 |
Goodwill impairment | 12,026 | 0 |
Restructuring | 949 | 0 |
Change in fair value of contingent consideration | 7 | (1,153) |
Total costs and operating expenses | 42,311 | 31,424 |
Loss from operations | (38,630) | (27,833) |
Other income (expense): | ||
Interest income | 24 | 40 |
Interest expense | (1,411) | (1,388) |
Total other expense, net | (1,387) | (1,348) |
Loss before income taxes | (40,017) | (29,181) |
Income tax benefit | 0 | 0 |
Net loss | (40,017) | (29,181) |
Other comprehensive income (loss) | ||
Unrealized (loss)/gain on marketable securities | (57) | 6 |
Foreign currency translation adjustment | (166) | (226) |
Comprehensive loss | $ (40,240) | $ (29,401) |
Net loss per common share, basic (in dollars per share) | $ (1.42) | $ (1.04) |
Net loss per common share, diluted (in dollars per share) | $ (1.42) | $ (1.04) |
Weighted average shares outstanding, basic (in shares) | 28,118,090 | 28,031,686 |
Weighted average shares outstanding, diluted (in shares) | 28,118,090 | 28,031,686 |
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) |
Balance at beginning of period (in shares) at Dec. 31, 2020 | 27,991,425 | |||||
Balance at beginning of period at Dec. 31, 2020 | $ 126,583 | $ 28 | $ 487,290 | $ (361,015) | $ 280 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized loss on marketable securities | 6 | 6 | ||||
Foreign currency translation adjustment | (226) | (226) | ||||
Stock option exercises (in shares) | 27,509 | |||||
Stock option exercises | 169 | 169 | ||||
Stock-based compensation (in shares) | 94,231 | |||||
Stock-based compensation | 2,910 | 2,910 | ||||
Employee stock purchase plan shares issued (in shares) | 0 | |||||
Net loss | (29,181) | (29,181) | ||||
Balance at end of period (in shares) at Mar. 31, 2021 | 28,113,165 | |||||
Balance at end of period at Mar. 31, 2021 | 100,261 | $ 28 | 490,369 | (390,196) | 60 | |
Balance at beginning of period (in shares) at Dec. 31, 2020 | 27,991,425 | |||||
Balance at beginning of period at Dec. 31, 2020 | 126,583 | $ 28 | 487,290 | (361,015) | 280 | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (117,700) | |||||
Balance at end of period (in shares) at Dec. 31, 2021 | 6,666 | 27,957,223 | ||||
Balance at end of period at Dec. 31, 2021 | 105,726 | $ 0 | $ 28 | 584,613 | (478,698) | (217) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Unrealized loss on marketable securities | (57) | (57) | ||||
Foreign currency translation adjustment | $ (166) | (166) | ||||
Stock option exercises (in shares) | 35,478 | 0 | 35,478 | |||
Stock option exercises | $ 66 | 66 | ||||
Stock-based compensation (in shares) | 0 | 192,138 | ||||
Stock-based compensation | 3,028 | 3,028 | ||||
Employee stock purchase plan shares issued (in shares) | 0 | 94,226 | ||||
Employee stock purchase plan shares issued | 182 | 182 | ||||
Net loss | (40,017) | (40,017) | ||||
Balance at end of period (in shares) at Mar. 31, 2022 | 6,666 | 28,279,065 | ||||
Balance at end of period at Mar. 31, 2022 | $ 68,762 | $ 0 | $ 28 | $ 587,889 | $ (518,715) | $ (440) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (40,017) | $ (29,181) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 1,567 | 1,241 |
Amortization of intangible assets | 160 | 160 |
Stock-based compensation expense | 3,032 | 2,910 |
Amortization of premiums on marketable securities, net | 173 | 412 |
Amortization of debt issuance costs | 378 | 328 |
Amortization of right-of-use assets | 160 | 180 |
Goodwill impairment | 12,026 | 0 |
Change in fair value of contingent consideration | 7 | (1,153) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 655 | (317) |
Inventory | (1,212) | (879) |
Prepaid expenses and other current assets | (3,487) | 1,104 |
Other assets | 120 | (250) |
Accounts payable | (2,641) | (2,091) |
Accrued liabilities | 1,532 | 1,500 |
Operating lease liabilities | (14) | (237) |
Other long-term liabilities | (48) | 0 |
Net cash used in operating activities | (27,609) | (26,273) |
Cash flows from investing activities | ||
Purchases of available-for-sale marketable securities | 0 | (9,135) |
Sales of available-for-sale marketable securities | 2,500 | 0 |
Maturities of available-for-sale marketable securities | 14,587 | 25,000 |
Purchases of property and equipment | (1,088) | (3,693) |
Net cash provided by investing activities | 15,999 | 12,172 |
Cash flows from financing activities | ||
Payment of contingent consideration | (290) | (2,547) |
Proceeds from stock options exercises | 66 | 169 |
Proceeds from employee stock purchase plan | 182 | 0 |
Net cash used in financing activities | (42) | (2,378) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (100) | (124) |
Net change in cash, cash equivalents and restricted cash | (11,752) | (16,603) |
Cash, cash equivalents and restricted cash, at the beginning of the period | 24,221 | 25,384 |
Cash, cash equivalents and restricted cash, at the end of the period | 12,469 | 8,781 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 0 | 35 |
Cash paid for interest | 1,025 | 1,125 |
Supplemental disclosure of noncash investing and financing activities: | ||
Change in unrealized loss on marketable securities | 57 | (6) |
Change in unpaid purchases of property and equipment | (97) | (67) |
Escrow release | $ 17 | $ 0 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Acutus Medical, Inc. (the “Company”) is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. The Company designs, manufactures and markets a range of tools for catheter-based ablation procedures to treat various arrhythmias. The Company’s product portfolio includes novel access sheaths, transseptal crossing tools, diagnostic and mapping catheters, ablation catheters, mapping and imaging consoles and accessories, as well as supporting algorithms and software programs. 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, 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 March 31, 2022 and December 31, 2021, the Company had cash, cash equivalents and marketable securities of $78.6 million and $107.9 million, respectively. For the three months ended March 31, 2022 and 2021, net losses were $40.0 million and $29.2 million, respectively, and net cash used in operating activities was $27.6 million and $26.3 million respectively. As of March 31, 2022 and December 31, 2021, the Company had an accumulated deficit of $518.7 million and $478.7 million, respectively, and working capital of $87.1 million and $107.8 million, respectively. Prior to the Company’s initial public offering (“IPO”) in August 2020, operations had been financed primarily by aggregate net proceeds from the sale of convertible preferred stock and principal of converted debt of $253.9 million, as well as other indebtedness. On August 10, 2020, the Company issued 10,147,058 shares of common stock in its IPO, which included 1,323,529 shares of common stock issued upon the exercise in full by the underwriters of an option to purchase additional shares of common stock, at the public offering price less underwriting discounts and commissions. The price to the public was $18.00 per share, for net proceeds of $166.3 million. In July 2021, the Company issued 6,325,000 shares of common stock in a public offering, which included 825,000 shares of common stock issued upon the underwriter’s exercise in full of an option to purchase additional shares of common stock. The price to the public for each share was $14.00. The Company received gross proceeds of $88.6 million from the offering. Net of underwriting discounts and commission and other offering expenses, the Company received proceeds of $82.7 million from the offering. With the closing of the Company’s IPO in August 2020, the follow on offering in July 2021 and the reduction in force ("RIF") announced in January 2022, Management believes the Company’s current cash, cash equivalents and marketable securities are sufficient to fund operations for at least the next 12 months. Under Accounting Standard Codification (“ASC”) Subtopic 205-40, Presentation of Financial Statements—Going Concern (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the consolidated financial statements are issued. As required under ASC 205-40, management’s evaluation should initially not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the consolidated financial statements are issued. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. Substantial Doubt Raised In performing the first step of the evaluation, the Company concluded that the following conditions raised substantial doubt about its ability to continue as a going concern: • History of net losses of $40.0 million and $29.2 million for the three months ended March 31, 2022 and 2021, respectively, and $117.7 million and $102.0 million for the years ended December 31, 2021 and December 31, 2020, respectively; • Accumulated deficit of $518.7 million and $478.7 million as of March 31, 2022 and December 31, 2021, respectively; • Disruptions in elective procedure volumes related to unanticipated impacts from COVID-19; and • History of negative gross margins. Consideration of Management’s Plans In performing the second step of this assessment, the Company is required to evaluate whether it is probable that its plans will be effectively implemented within one year after the consolidated financial statements are issued and whether it is probable those plans will alleviate the substantial doubt about its ability to continue as a going concern. The Company has identified several potential actions to strengthen liquidity and optimize resources in the event actual results and other planned activities differ materially from projections. The Company is prepared to implement these actions as required by business and market conditions. These actions would improve the available cash balances, liquidity and cash flows generated from operations over the twelve-month period from the date the consolidated financial statements are issued, as follows: • Reduction in force that would be intended to extend the cash runway necessary to fund operations; • Total compensation reductions for senior executives to strengthen liquidity and to preserve key research and development, commercial and functional roles; • Increased internal identification of efficiencies within corporate functions to reduce certain external consulting and business support spend; and • Deferral and reprioritization of certain research and development programs that would involve reduced program and headcount spend. Management Assessment of Ability to Continue as a Going Concern The Company has a history of operating losses and negative cash flows from operations. However, despite these conditions, the Company believes management’s plans, as described more fully above, will provide sufficient liquidity to meet its financial obligations and maintain levels of liquidity as specifically required under the 2019 Credit Agreement, as defined below. Therefore, management concluded these plans alleviate the substantial doubt that was raised about the Company’s ability to continue as a going concern for at least twelve months from the date that the consolidated financial statements were issued. Future Plans and Considerations Although not considered for purposes of the Company’s assessment of whether substantial doubt was alleviated, the Company has retained several specialized third-party consultants and advisors to review its strategy as well as a range of options to fund the long-term growth of the Company, including non-dilutive financing, partnerships and licensing and distribution agreements. The Company’s plans are subject to inherent risks and uncertainties, which become significantly magnified when the effects of the current pandemic and related financial crisis are included in the assessment. Accordingly, there can be no assurance that the Company’s plans can be effectively implemented and, therefore, that the conditions can be effectively mitigated. The Company may need to raise additional funds through the issuance of debt and/or equity securities or otherwise. Until such time, if ever, that the Company can generate revenue sufficient to achieve profitability, the Company expects to finance its operations through equity or debt financings, which may not be available to the Company on the timing needed or on terms that the Company deems to be favorable. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interest of its stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. The Company may be required to delay, limit, reduce or terminate its product discovery and development activities or future commercialization efforts. Impact of COVID-19 Beginning in March 2020, the COVID-19 pandemic and the measures imposed to contain this pandemic disrupted and are expected to continue to impact the Company's business. For example, on March 19, 2020, the Executive Department of the State of California issued Executive Order N-33-20, ordering all individuals in the State of California to stay home or at their place of residence except as needed to maintain continuity of operations of the federal critical infrastructure sectors. The Company's primary operations are located in Carlsbad, California. As a result of such order, the majority of the Company’s employees have telecommuted, which may impact certain of its operations over the near term and long term. Moreover, beginning in March 2020 and continuing through the filing of this Form 10-Q, access to hospitals and other customer sites was restricted to essential personnel, which negatively impacted the Company’s ability to install its AcQMap consoles and workstations in new accounts and for sales representatives and mappers to promote the use of the Company’s products with physicians. Moreover, hospitals and other therapeutic centers suspended many elective procedures, resulting in a significantly reduced volume of procedures using the Company's products. In addition, all clinical trials in Europe were suspended with follow-ups for clinical trials done via telecom, and the Company believes enrollment timing in its planned clinical trials will be slowed due to COVID-19 driven delayed access to enrollment sites. As a result of the interruptions to the business due to COVID-19, the Company enacted a cash conservation program, which included delaying certain non-critical capital expenditures and other projects and implementing a hiring freeze, headcount reductions and temporary compensation reductions (through August 2020). The effects of the pandemic began to decrease in late April 2020 as electrophysiology labs began reopening and procedure volumes began increasing as compared to COVID-19 related low points in March 2020. The Company’s IPO in August 2020 provided resources sufficient to restore compensation reductions to pre-COVID levels, as well as to restart hiring and capital expenditures in support of its growth. Over the past 24-months, the Company has continued to observe intermittent suspension of many elective procedures associated with the resurgence of COVID-19 in geographies where it sells, markets and distributes its products. In addition, the impact of COVID-19 has varied by region and by healthcare facility, which has hampered the Company’s ability to forecast the sustained impact on its business from COVID-19. The Company continues to see intermittent suspension of many elective procedures in many hospitals, resulting in reduced volume of procedures using its products. In addition, the Company has experienced personnel and other resource shortages at hospitals at which procedures using its products otherwise could be used; disruptions or restrictions on the ability of many of its employees and of third parties on which it relies to work effectively, including because of adherence to governmental orders or recommendations or to internal policies intended to reduce the spread of COVID-19; and temporary closures of its facilities and of the facilities of its customers and suppliers. The magnitude of the impact of the COVID-19 pandemic on productivity, results of operations and financial position, and its disruption to the Company’s business and clinical programs and timelines, will depend, in part, on the length and severity of the pandemic, associated restrictions and other measures designed to prevent the spread of COVID-19 and on the Company’s ability to conduct business in the ordinary course. Quarantines, shelter-in-place, vaccine mandates and similar government orders have also impacted, and may continue to impact, the Company’s third-party manufacturers and suppliers, and could in turn adversely impact the availability or cost of materials, which could disrupt the Company’s supply chain. The markets the Company serves are likely to see continued impacts from COVID-19 for the foreseeable future, and the emergence of new variants of COVID-19 creates significant uncertainty as to how long COVID-19 will continue to impact the Company’s business. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
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, expenses and disclosures of contingent assets and liabilities. The most significant estimates and assumptions in the Company’s condensed consolidated financial statements include, but are not limited to, revenue recognition, useful lives of intangible assets, assessment of impairment of goodwill, measurement of operating lease liabilities, and the fair value of common stock, stock options, warrants, intangible assets and contingent consideration. 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 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. 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 March 31, 2022 and December 31, 2021, exceeded federally insured limits. Restricted cash serves as collateral for the Company’s corporate credit card program. The following table reconciles cash, cash equivalents and restricted cash in the condensed consolidated balance sheets to the total shown on the condensed consolidated statement of cash flows (in thousands): March 31, December 31, (unaudited) Cash and cash equivalents $ 12,319 $ 24,071 Restricted cash 150 150 Total cash, cash equivalents and restricted cash $ 12,469 $ 24,221 Marketable 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 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 investees’ 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 months ended March 31, 2022 and 2021. 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. Cash and restricted cash are maintained in accounts with financial institutions which, at times, may exceed the Federal depository insurance coverage of $0.25 million. 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. The Company’s marketable securities portfolio primarily consists of investments in commercial paper, Yankee debt securities, supranational, U.S. treasury securities, asset-backed securities and short-term high credit quality corporate debt securities. Revenue from Contracts with Customers The Company accounts for revenue earned from contracts with customers under 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 if 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, 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 U.S., the Company also has a 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. 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 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, thus the customer obtains control and revenue is recognized at that point in time. Revenue is recognized on delivery for disposable products shipped via 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 sales 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 includes, but is not limited to, transactions where the specific performance obligations are sold separately, list prices and 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 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 March 31, 2022 and December 31, 2021. In May 2020, the Company entered into bi-lateral distribution agreements with Biotronik (the “Bi-Lateral Distribution Agreements”). 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 specified transfer prices 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 following table sets forth the Company’s revenue for disposables, systems and service/other for the three months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) Disposables $ 3,211 $ 2,342 Systems — 969 Service/Other 470 280 Total revenue $ 3,681 $ 3,591 The following table provides revenue by geographic location for the three months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) United States $ 2,023 $ 1,581 Outside the United States 1,658 2,010 Total revenue $ 3,681 $ 3,591 Inventory Inventory is comprised of raw materials, direct labor and manufacturing overhead and 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 based on management’s review of inventories on hand, compared to estimated future usage and sales, shelf-life and assumptions about the likelihood of obsolescence of $1.0 million and $0.1 million for the three months ended March 31, 2022 and 2021, respectively. Accounts Receivable 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 March 31, 2022 and December 31, 2021. 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 consist of acquired developed technology, acquired in-process technology, trademarks and trade names and a customer-related intangible which were acquired as part of the acquisition of Rhythm Xience, Inc. (“Rhythm Xience”) in June 2019. The Company’s intangible assets also include 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 was classified as an indefinite-lived intangible asset, until the receipt of Food and Drug Administration (the “FDA”) approval for the technology in January 2020. Once the FDA approval was received, the in-process technology was classified as a finite-lived intangible and amortization for in-process technology began. 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. For the three months ended March 31, 2022, the Company fully impaired its goodwill balance of $12.0 million. Refer to Note 8 - Goodwill and Intangible Assets for further details. 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 months ended March 31, 2022 and 2021, 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. Lessee Leases The Company accounts for its lessee leases 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 sheet 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. 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 elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the guidance as an accounting policy election. 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 The Company is 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. In April 2021, the Company and Biotronik entered into a Feasibility and Development Agreement to pursue the development of hardware, software and IT infrastructure to implement the Qubic Connect System ("QBS"). The QBS will allow data transfer from multiple diagnostic and therapeutic medical products during an electrophysiology procedure to be aggregated and analyzed for the purposes of designing improved treatment protocols. 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 (“SG&A”) 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. The Company expenses all SG&A costs as incurred. Restructuring Restructuring expense consists of severance expenses related to employees affected by the organizational RIF. The RIF was made to align resources with the Company's current strategic direction. Employee Retention Credit The Coronavirus Aid, Relief and Economic Security (“CARES”) Act provides an employee retention credit (“CARES Employee Retention Credit”), which is a refundable tax credit against certain employment taxes of up to $5 thousand per employee for eligible employers. The tax credit is equal to 50% of qualified wages paid to employees during a quarter, capped at $10 thousand of qualified wages per employee per calendar year through December 31, 2020. Additional relief provisions were passed by the United States government, which extended and expanded the qualified wage caps on these credits through September 30, 2021. Based on these additional provisions, the tax credit is now equal to 70% of qualified wages paid to employees during a quarter beginning with the first quarter of 2021, and the limit on qualified wages per employee has been increased to $10 thousand of qualified wages per quarter instead of per calendar year. The Company qualifies for the tax credit under the CARES Act. The Company filed 2021 Form 941-X Adjusted Employer’s Quarterly Federal Tax Return or Claim for Refund for the quarters ended March 31, 2021 and June 30, 2021 on March 24, 2022. The refunds due are an aggregate of $4.0 million for the quarters ended March 31, 2021 and June 30, 2021. The Company filed its 2020 Form 941-X Adjusted Employer’s Quarterly Federal Tax Return or Claim for Refund for the period March 12, 2020 through December 31, 2020 on March 31, 2022. The refunds due for that period are an aggregate of $0.6 million. The Company elected to classify the ERC amounts as a reduction to payroll tax expense. During the three months ended March 31, 2022, the Company recorded $1.5 million, $1.4 million and $1.7 million related to the CARES Employee Retention Credit within cost of products sold, research and development expense and SG&A expense, respectively, on the Company’s condensed consolidated statement of operations and comprehensive loss. As of March 31, 2022, the Company has a $4.6 million receivable balance from the United States government related to the CARES Act, which is recorded in “Prepaid expenses and other current assets” on the Company’s condensed consolidated balance sheet. Fair Value Measurements 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 has been used in determining the inputs used in 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 that are financial instruments whose values are determined 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 months ended March 31, 2022 and 2021. As of March 31, 2022 and December 31, 2021, 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 the instruments. 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 March 31, 2022 and December 31, 2021 (in thousands): Fair Value Measurements as of March 31, 2022 (unaudited) Quoted Significant Significant Fair Value at Assets included in: Cash and cash equivalents Money market securities $ 10,376 $ — $ — $ 10,376 Marketable securities at fair value Corporate debt securities — 4,046 — 4,046 U.S. treasury securities — 5,042 — 5,042 Commercial paper — 36,775 — 36,775 Yankee debt securities — 3,877 — 3,877 Supranational — 3,019 — 3,019 Asset-backed securities — 13,547 — 13,547 Total fair value $ 10,376 $ 66,306 $ — $ 76,682 Liabilities included in: Contingent consideration $ — $ — $ 1,700 $ 1,700 Total fair value $ — $ — $ 1,700 $ 1,700 Fair Value Measurements as of December 31, 2021 Quoted Significant Significant Fair Value at Assets included in: Cash and cash equivalents Money market securities $ 21,893 $ — $ — $ 21,893 Marketable securities at fair value Corporate debt securities — 18,860 — 18,860 U.S. treasury securities — 5,064 — 5,064 Commercial paper — 36,759 — 36,759 Yankee debt securities — 3,932 — 3,932 Supranational — 3,051 — 3,051 Asset-backed securities — 16,156 — 16,156 Total fair value $ 21,893 $ 83,822 $ — $ 105,715 Liabilities included in: Contingent consideration $ — $ — $ 2,000 $ 2,000 Total fair value $ — $ — $ 2,000 $ 2,000 The fair value of the Company’s money market securities is determined using quoted market prices in active markets for identical assets. The Company’s portfolio of marketable securities is comprised of commercial paper, asset-backed securities, U.S. treasury securities, Yankee debt securities, supranational and short-term highly liquid, high credit quality corporate debt securities. The fair value for the available-for-sale marketable securities is determined based on trade prices in active markets for identical assets (Level 1 inputs) or 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. The following table presents changes in Level 3 liabilities measured at fair value for the three months ended March 31, 2022 (in thousands): Contingent Balance, December 31, 2021 $ 2,000 Payment of contingent consideration (290) Escrow release (1) (17) Change in fair value 7 Balance, March 31, 2022 (unaudited) $ 1,700 (1) As part of the Rhythm Xience acquisition (see Note 3), the first $0.5 million earned related to revenue success payments was paid at the end of the first month following the end of the quarter in which the revenue success payments were earned, into an escrow account until the expiration of an additional 18 month hold-back period commencing with the end of the quarter during which such revenue success payment amounts were earned. Amounts noted above were released from the escrow account. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-dated volatilities) inputs. The fair value of the contingent consideration from the acquisition of Rhythm Xience (see Note 3) represents the estimated fair value of future payments due to the sellers of Rhythm Xience based on the achievement of certain milestones and revenue-based targets in certain years. The initial fair value of the revenue-based con |
Asset Acquisition and Business
Asset Acquisition and Business Combination | 3 Months Ended |
Mar. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Asset Acquisition and Business Combination | Asset Acquisition and Business Combination Biotronik Asset Acquisition In July 2019, the Company entered into a License and Distribution Agreement with Biotronik and VascoMed GmbH (the “Biotronik Parties”) to obtain certain licenses to the Biotronik Parties’ patents, whereby the Company acquired certain manufacturing equipment and obtained from the Biotronik Parties a license under certain patents and technology to develop, commercialize, distribute and manufacture the AcQBlate FORCE ablation catheters and Qubic Force Device (the “Biotronik Asset Acquisition"). In exchange for the rights granted to the Company, the Company made cash payments totaling $10.0 million during the year ended December 31, 2020 and issued 273,070 shares of Series D convertible preferred stock valued at $5.0 million during the three months ended March 31, 2020. The implied value of $5.0 million was recorded as an accrued liability as of December 31, 2019. In accordance with ASC 805, the Biotronik Asset Acquisition was accounted for as an asset acquisition as substantially all of the $15.0 million value transferred to Biotronik was allocated to intellectual property. On the acquisition date, the products licensed had not yet received regulatory approval and the intellectual property did not have an alternative use. Accordingly, the $15.0 million paid to Biotronik was immediately charged to research and development expense—license acquired in the condensed consolidated statement of operations and comprehensive loss in July 2019. Additional contingent milestone payments of up to $10.0 million, of which $2.0 million has been paid as of March 31, 2022, are to be made to the Biotronik Parties contingent upon certain regulatory approvals and first commercial sale. In further consideration of the rights granted, beginning with the Company’s first commercial sale of the first force sensing ablation catheter within the licensed product line, the Company also makes per unit royalty payments. As of March 31, 2022, less than $0.1 million has been included within accrued liabilities for these royalties. The Company determined that the remaining $8.0 million contingent milestones are not probable and estimable and therefore have not been recorded as a liability as of March 31, 2022 and December 31, 2021. Upon regulatory approval in December 2020 of the Company’s force sensing ablation catheter in Europe, the $2.0 million milestone was capitalized and is being amortized, and the royalty payments are recorded as cost of products sold as sales of catheters are recognized. Rhythm Xience Business Combination On June 18, 2019 (the “Acquisition Date”), the Company acquired an integrated family of transseptal crossing and steerable introducer systems through its acquisition of Rhythm Xience for $3.0 million in cash in exchange for all of the stock of Rhythm Xience (the “Rhythm Xience Acquisition”). The cash payment did not include the potential $17.0 million in earn out consideration, of which $2.2 million was paid with the issuance of Series D convertible preferred stock in February 2020 and the remainder is to be paid based on the achievement of certain regulatory milestones and revenue milestones. In accordance with ASC 805, the Rhythm Xience Acquisition was accounted for as a business combination. As part of the Rhythm Xience Acquisition, the Company recorded a contingent consideration liability for potential additional payments due to the sellers of Rhythm Xience if certain regulatory approval milestones and revenue milestones are achieved. The initial contingent consideration liability of $13.4 million was based on the fair value of the contingent consideration liability at the Acquisition Date. During the year ended December 31, 2020, the Company issued 119,993 shares of Series D convertible preferred stock and paid $2.5 million of the contingent consideration for the achievement of certain regulatory and revenue milestones. During the year ended December 31, 2021, the Company paid an additional $3.4 million of the contingent consideration for the achievement of certain regulatory and revenue milestones. During the three months ended March 31, 2022, the Company paid an additional $0.3 million of the contingent consideration for the achievement of certain revenue milestones. Additionally, the Company recorded less than a $0.1 million increase and a $1.2 million decrease to the fair value of the contingent consideration liability for the three months ended March 31, 2022 and 2021, respectively, which is included in change in fair value of contingent consideration in the condensed consolidated statements of operations and comprehensive |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Marketable securities consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, 2022 (unaudited) Amortized Gross Gross Fair Value Available-for-sale securities - short-term: Corporate debt securities $ 4,046 $ — $ — $ 4,046 U.S. treasury securities 5,076 — (34) 5,042 Commercial paper 36,775 — — 36,775 Yankee debt securities 3,897 — (20) 3,877 Supranational 3,027 — (8) 3,019 Asset-backed securities, short-term 9,565 — (32) 9,533 Total available-for-sale securities - short-term 62,386 — (94) 62,292 Asset-backed securities, long term 4,022 — (8) 4,014 Total available-for-sale securities $ 66,408 $ — $ (102) $ 66,306 December 31, 2021 Amortized Gross Gross Fair Value Available-for-sale securities - short-term: Corporate debt securities, short-term $ 15,786 $ — $ (6) $ 15,780 U.S. treasury securities 5,073 — (9) 5,064 Commercial paper 36,759 $ — — 36,759 Yankee debt securities 3,941 — (9) 3,932 Supranational 3,054 — (3) 3,051 Asset-backed securities, short-term 12,128 — (12) 12,116 Total available-for-sale securities - short-term 76,741 — (39) 76,702 Corporate debt securities, long-term 3,082 — (2) 3,080 Asset-backed securities, long-term 4,044 — (4) 4,040 Total available-for-sale securities - long-term 7,126 — (6) 7,120 Total available-for-sale securities $ 83,867 $ — $ (45) $ 83,822 As of March 31, 2022, the Company’s available-for-sale securities classified as short-term of $62.3 million mature in one year or less and the available-for-sale securities classified as long-term of $4.0 million mature within four years. As of December 31, 2021, the Company’s available-for-sale securities classified as short-term of $76.7 million mature in one year or less and the available-for-sale securities classified as long-term of $7.1 million mature within two years. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands): March 31, December 31, (unaudited) Raw materials $ 7,898 $ 6,779 Work in process 2,181 1,772 Finished goods 7,541 7,857 Total inventory $ 17,620 $ 16,408 |
Lessor Sales-Type Leases
Lessor Sales-Type Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Lessor Sales-Type Leases | Lessor Sales-Type Leases The Company recognizes revenue and costs, as well as a lease receivable, at the time embedded sales-type leases within its deferred equipment agreements commence. There was no lease revenue related to sales-type leases for the three months ended March 31, 2022. There was $0.9 million lease revenue related to sales-type leases for the three months ended March 31, 2021, and is included within revenue in the accompanying condensed consolidated statements of operations and comprehensive loss. Costs related to embedded leases within the Company’s deferred equipment agreements are included in cost of products sold in the accompanying condensed consolidated statements of operations and comprehensive loss. The Company has a short-term lease receivable of $0.7 million and $0.9 million included in prepaid expenses and other current assets as of March 31, 2022 and December 31, 2021, respectively. The Company has a long-term lease receivable of $0.6 million and $0.7 million included in other assets as of March 31, 2022 and December 31, 2021, respectively. As of March 31, 2022, estimated future maturities of sales-type lease receivables for each of the following years are as follows (in thousands): Nine months ending December 31, 2022 $ 637 Year ending December 31, 2023 434 Year ending December 31, 2024 253 Year ending December 31, 2025 50 Year ending December 31, 2026 — Lease receivable $ 1,374 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net The Company’s property and equipment, net, consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, December 31, (unaudited) Medical diagnostic equipment $ 17,330 $ 16,759 Furniture and fixtures 433 433 Office equipment 1,573 1,538 Laboratory equipment and software 5,320 5,302 Leasehold improvements 580 582 Construction in process 1,083 958 Total property and equipment 26,319 25,572 Less: accumulated depreciation (13,357) (11,902) Property and equipment, net $ 12,962 $ 13,670 Property and equipment includes certain medical diagnostic equipment, 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 expenses the cost of the equipment when it is subsequently sold or enters into a sales-type lease agreement. See also Note 6—Lessor Sales-Type Leases above. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The table below summarizes goodwill and intangible assets activities as of March 31, 2022 and December 31, 2021 (in thousands): Goodwill Intangible Balance, December 31, 2021 $ 12,026 $ 5,013 Amortization expense — (160) Goodwill impairment (12,026) — Balance, March 31, 2022 (unaudited) $ — $ 4,853 During the first quarter of 2022, the Company experienced a significant decline in stock price which reduced the market capitalization below the carrying value of the Company. The Company performed a quantitative assessment of the fair value of its reporting unit. The assessment used a combination of quoted market prices as well as present value calculations which included both the income and market approach. Based on the assessment, the Company concluded that the fair value of the reporting unit was less than its carrying amount in an amount that resulted in the Company fully impairing its goodwill balance of $12.0 million during the three months ended March 31, 2022. Estimated Weighted Intangible Accumulated March 31, (unaudited) Developed technology 10.0 7.3 $ 4,200 $ (1,125) $ 3,075 Customer-related intangible 5.0 2.3 100 (55) 45 Licensed intangibles 10.0 8.7 2,000 (267) 1,733 Total $ 6,300 $ (1,447) $ 4,853 Estimated Weighted Intangible Accumulated December 31, 2021 Developed technology 10.0 7.6 $ 4,200 $ (1,020) $ 3,180 Customer-related intangible 5.0 2.5 100 (50) 50 Licensed intangibles 10.0 8.9 2,000 (217) 1,783 Total $ 6,300 $ (1,287) $ 5,013 Acquired in-process technology was classified as an indefinite-lived intangible asset until the receipt of FDA approval for the technology in January 2020. Once the FDA approval was received, the in-process technology was reclassified as developed technology and amortization began. The Company recorded amortization expense related to the above intangible assets of $0.2 million for both the three months ended March 31, 2022 and 2021, respectively. For the three months ended March 31, 2022 and 2021, the Company determined that there was no impairment of intangible assets. The following table shows the remaining amortization expense associated with amortizable intangible assets as of March 31, 2022 (in thousands): Developed Customer- Licensed Total Nine months ending December 31, 2022 $ 315 $ 15 $ 150 $ 480 Year ending December 31, 2023 420 20 200 640 Year ending December 31, 2024 420 10 200 630 Year ending December 31, 2025 420 — 200 620 Year ending December 31, 2026 420 — 200 620 Thereafter 1,080 — 783 1,863 Total $ 3,075 $ 45 $ 1,733 $ 4,853 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, December 31, (unaudited) Compensation and related expenses $ 7,304 $ 7,088 Professional fees 857 158 Deferred revenue 430 401 Sales and use tax 190 71 Clinical studies 483 541 Clinician Council payable 376 358 Accrued royalties 239 129 Accrued restructuring 394 — Other 359 350 Total accrued liabilities $ 10,632 $ 9,096 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Outstanding debt as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands): March 31, December 31, (unaudited) 2019 Credit Agreement (1) $ 44,550 $ 44,550 Total debt, gross 44,550 44,550 Less: Unamortized debt discount and fees (3,757) (4,135) Total long-term debt $ 40,793 $ 40,415 (1) The 2019 Credit Agreement includes final payment fees of $4.6 million. 2019 Credit Agreement On May 20, 2019, the Company entered into a credit agreement (the “2019 Credit Agreement”). The 2019 Credit Agreement provided the Company with a senior term loan facility in aggregate principal amount of $70.0 million, of which the Company borrowed $40.0 million upon closing. Of the remaining $30.0 million, none is available for borrowing. The 2019 Credit Agreement bears interest per annum at 7.75% plus LIBOR for such interest period and the principal amount of term loans outstanding under the 2019 Credit Agreement is due on May 20, 2024. The 2019 Credit Agreement provides for final payment fees of an additional $4.6 million that are due upon prepayment or on the maturity date or upon acceleration. Upon the occurrence and during an event of default, which includes but is not limited to payment default, covenant default or the occurrence of a material adverse change, the lenders may declare all outstanding principal and accrued and unpaid interest immediately due and payable, all unfunded commitments would be terminated, there would be an increase in the applicable interest rate by 10% per annum, and the lenders would be entitled to exercise their other rights and remedies provided for under the 2019 Credit Agreement. Additionally, the lenders may request repayment of a portion of obligations outstanding under the 2019 Credit Agreement to the extent of the Company’s receipt of any (i) net casualty proceeds or (ii) net asset sales proceeds, as defined. These acceleration and early payment features are an embedded derivative that is separately measured from the loan host instrument and classified with the loan host instrument. In connection with the issuance of the 2019 Credit Agreement, the Company issued liability-classified warrants with a fair value of $0.9 million to purchase 419,992 shares of Series C convertible preferred stock at $16.67 per share. These warrants were subsequently automatically converted into warrants to purchase an equal number of shares of the Company’s Series D convertible preferred stock at $16.67 per share and then were automatically converted into warrants to purchase an equal number of shares of common stock at $16.67 per share. The initial recognition of the warrant liability and direct fees of $1.2 million and final payment fees of $4.6 million for the 2019 Credit Agreement resulted in a discount of $6.7 million, which is being amortized to interest expense over the term of the 2019 Credit Agreement using the effective interest method. The Company’s obligations under the 2019 Credit Agreement are secured by substantially all of its assets, including its intellectual property, and is guaranteed by Acutus NV. The 2019 Credit Agreement contains customary affirmative and negative covenants, including with respect to the Company’s ability to enter into fundamental transactions, incur additional indebtedness, grant liens, pay any dividend or make any distributions to its holders, make investments and merge or consolidate with any other person or engage in transactions with its affiliates, but does not include any financial covenants, other than a minimum liquidity requirement. As of March 31, 2022, the Company was in compliance with all such covenants. |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Operating Leases | Operating Leases The Company leases approximately 50,800 square feet of office space for its corporate headquarters and manufacturing facility in Carlsbad, California under a noncancelable 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. The Company also leases approximately 3,900 square feet of office space in Zaventem, Belgium under a noncancelable operating lease that expires on December 31, 2022. 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 Company has a renewal option for an additional three-year term upon the expiration date of the lease, which has been included in the calculation of the right-of-use asset as it is reasonably certain to be exercised. The following table summarizes quantitative information about the Company’s operating leases for the three months ended March 31, 2022 and 2021 (dollars in thousands): Three Months Ended March 31, 2022 Three Months Ended March 31, 2021 (unaudited) Operating cash flows from operating leases $ 98 $ 261 Weighted average remaining lease term – operating leases (in years) 3.4 1.4 Weighted average discount rate – operating leases 7.0 % 7.0 % The following table provides the components of the Company’s lease cost (in thousands): Three Months Ended March 31, 2022 Three Months Ended March 31, 2021 (unaudited) Operating leases Operating lease cost $ 247 $ 216 Variable lease cost 77 83 Total rent expense $ 324 $ 299 As of March 31, 2022, future minimum payments under the non-cancelable operating leases under ASC 842 were as follows (in thousands): Nine months ending December 31, 2022 $ 806 Year ending December 31, 2023 1,135 Year ending December 31, 2024 1,167 Year ending December 31, 2025 1,151 Year ending December 31, 2026 1,185 Thereafter 1,221 Total 6,665 Less: present value discount (1,693) Operating lease liabilities $ 4,972 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and ContingenciesAs of March 31, 2022, the Company and certain of its current 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 (case numbers 22CV206 and 22CV0388). 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 | 3 Months Ended |
Mar. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants As of March 31, 2022 and December 31, 2021, the outstanding warrants to purchase the Company’s common stock were comprised of the following: Equity Upon Exercise Price Expiration Date March 31, December 31, (unaudited) Warrants issued in 2015 Common stock $ 5.25 1/30/25 3,808 3,808 Warrants issued with 2018 Convertible Notes Common stock $ 0.10 6/7/28 346,689 346,689 Warrants issued with 2018 Term Loan Common stock $ 16.67 7/31/28 26,998 26,998 Warrants issued with 2019 Credit Agreement Common stock $ 16.67 5/20/29 419,992 419,992 Total Warrants 797,487 797,487 There was no warrant activity for the three months ended March 31, 2022. The Company’s warrants provide the holder the option to purchase a specified number of shares for a specified price. The holder may exercise the warrant in cash or 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. Prior to the IPO, in accordance with ASC 815, the warrants, other than the ones issued in 2015, were recorded as liabilities at fair value at the issuance date (the 2015 warrants have been equity classified since their issuance). Changes in the fair value |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2022 | |
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. In connection with the issuance of Series A Common Equivalent 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, par value $0.001 per share, of the Company (the “Series A Certificate of Designation”) with the Secretary of State of the State of Delaware. The Series A Common Equivalent 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 Series A Common Equivalent 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 Series A Common Equivalent Preferred Stock is non-voting. The holder thereof may convert each share of Series A Common Equivalent Preferred Stock into 1,000 shares of common stock at its election, 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 Securities Exchange Act of 1934, as amended (the “Exchange Act”), including shares held by any “group” (as defined in Section 13(d) of the Exchange Act and applicable regulations of the Securities and Exchange Commission) 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, to 9.9%) of the total number of shares of common stock then issued and outstanding. Common Stock In July 2021, the Company issued 6,325,000 shares of common stock in a public offering, which included 825,000 shares of common stock issued upon the underwriter's exercise in full of an option to purchase additional shares of common stock. The price to the public for each share was $14.00. The Company received gross proceeds of $88.6 million from the offering. Net of underwriting discounts and commission and other offering expenses, the Company received proceeds of $82.7 million from the offering. During the three months ended March 31, 2022 and 2021, stock options to acquire 35,478 shares and 27,509 shares were exercised for shares of common stock. The Company received $0.1 million and $0.2 million for the exercise price of the stock options for the three months ended March 31, 2022 and 2021, respectively. 94,226 shares were issued related to the 2020 Employee Stock Purchase Plan (the “2020 ESPP”) for the three months ended March 31, 2022. No shares were issued related to the 2020 ESPP for the three months ended March 31, 2021. Additionally, during the three months ended March 31, 2022 and 2021, the Company issued 192,138 and 94,045 shares of common stock upon vesting of RSUs, respectively. Finally, the Company issued 186 shares of common stock for RSAs for the three months ended March 31, 2021. There were no issuances of RSAs during the three months ended March 31, 2022. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
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, RSAs, RSUs, stock appreciation rights, PSUs, performance shares and other equity-based awards to employees, directors and consultants, became effective on March 30, 2022. As of March 31, 2022, 6,000,000 shares of common stock were authorized for issuance under the 2022 Plan, all of which 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 March 31, 2022, 4,431,305 shares of common stock were authorized for issuance under the 2020 Plan and 1,005,667 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 March 31, 2022, 1,873,625 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 of future awards under the 2020 Plan. Stock Options The stock options 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 three months ended March 31, 2022 and 2021: Three Months Ended March 31, 2022 2021 (unaudited) Risk-free interest rate 1.76% 0.76% - 1.28% Expected dividend yield — — Expected term in years 6.0 7.0 Expected volatility 75% 60% - 75% The following table summarizes stock option activity during the three months ended March 31, 2022: Stock Weighted Weighted Aggregate Outstanding as of December 31, 2021 3,781,636 $ 13.12 7.6 $ 93 Options granted 562,250 2.41 Options exercised (35,478) 1.85 $ 310 Options forfeited (287,049) 8.30 Outstanding as of March 31, 2022 (unaudited) 4,021,359 $ 12.07 7.7 $ — Options vested and exercisable as of March 31, 2022 (unaudited) 1,733,894 $ 12.55 6.5 $ — 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 stock on the last day of the fiscal period, which was $1.39 and $3.41 as of March 31, 2022 and December 31, 2021, 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 three months ended March 31, 2022 was $1.59. As of March 31, 2022, the total unrecognized compensation related to unvested stock option awards granted was $25.3 million, which the Company expects to recognize over a weighted-average period of approximately 2.2 years. Performance-Based Restricted Stock Units (PSU) and Restricted Stock Units (RSU) In June 2019, the Company granted 567,509 PSUs, with a grant date fair value of $13.37. Vesting of the PSUs was dependent upon the satisfaction of both a service condition and a performance condition, which is an IPO or a change of control. The Company began recording compensation expense related to the PSUs upon the registration statement used in connection with the Company’s registration statement becoming effective on August 5, 2020, as the performance conditions were satisfied. The compensation expense was determined using the original grant date fair value and is being recognized over the remaining service period. The Company’s PSU and RSU activity for the three months ended March 31, 2022 was as follows: Number Weighted Unvested as of December 31, 2021 995,091 $ 13.47 Granted 1,045,586 2.41 Forfeited (128,771) 8.94 Vested (193,555) 13.67 Unvested as of March 31, 2022 (unaudited) 1,718,351 $ 7.06 Restricted Stock Awards (RSA) The Company had no RSA activity for the three months ended March 31, 2022. Employee Stock Purchase Plan The 2020 ESPP, which permits employees to purchase shares of the Company’s common stock, became effective on August 5, 2020 and 645,105 shares of common stock were authorized for sale under the 2020 ESPP. The 2020 ESPP was implemented by consecutive offering periods with a new offering period commencing on the first trading day on or after February 1 and August 1 of each year and terminating on the last trading day on or before July 31 and January 31, respectively. The first offering period began on February 1, 2021. In November 2021, the Company amended its ESPP offering periods beginning in 2022 after the January 31 purchase, to commence 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. The fair value of the 2020 ESPP shares is estimated using the Black-Scholes option pricing model. 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 months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) Cost of products sold $ 226 $ 157 Research and development 514 442 Selling, general and administrative 2,292 2,311 Total stock-based compensation $ 3,032 $ 2,910 |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2022 | |
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, PSUs, RSUs and warrants because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss 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: Three Months Ended March 31, Shares issuable upon: 2022 2021 (unaudited) Conversion of Series A Common Equivalent Preferred Stock 6,665,841 — Exercise of stock options 4,021,359 3,379,575 Exercise of common stock warrants 797,487 824,608 Vesting of PSUs and RSUs 1,718,351 466,785 Total 13,203,038 4,670,968 |
401(k) Retirement Plan
401(k) Retirement Plan | 3 Months Ended |
Mar. 31, 2022 | |
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 did not provide any contributions to the 401(k) retirement savings plan for the three months ended March 31, 2022 and 2021. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsIn August 2021, the Company entered into the Exchange Agreements with Deerfield Private Design Fund III, L.P., Deerfield Partners, L.P., OrbiMed Private Investments IV, LP and OrbiMed Royalty Opportunities II, LP pursuant to which the investors exchanged 6,665,841 shares of the Company’s common stock for 6,666 shares of Series A Common Equivalent Preferred Stock, par value $0.001 per share (see Note 14). The Company has a consulting agreement with a director and chairman of the Company’s board of directors. The Company recorded less than $0.1 million in SG&A expense in the condensed consolidated statements of operations and comprehensive loss for the consulting services for both the three months ended March 31, 2022 and 2021. Multiple preferred stock shareholders entered into the 2018 and 2019 Convertible Notes that also contained detached warrants. Additionally, OrbiMed Royalty Opportunities II, LP and Deerfield Private Design Fund II, L.P. entered into the 2019 Credit Agreement with the Company in 2019 for a total of $70.0 million, with $40.0 million being drawn as of March 31, 2022 and December 31, 2021. The Company recorded $1.4 million for both the three months ended March 31, 2022 and 2021, respectively, in interest expense related to these debt agreements. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Left-Heart Access Portfolio Sale In April 2022, the Company announced a definitive agreement to sell the Company’s left-heart access portfolio to Medtronic, Inc. (“Medtronic”). The sale of the Company’s left-heart access portfolio includes the AcQCross® line of sheath-compatible septal crossing devices, the AcQGuide® MINI integrated crossing device and sheath, the AcQGuide FLEX steerable introducer with integrated transseptal dilator and needle and the AcQGuide® VUE steerable sheaths. Under the terms of the agreement, Medtronic will make an upfront cash payment to the Company of $50.0 million upon the initial closing of the transaction, subject to the satisfaction of customary closing conditions, including expiration or early termination of all applicable waiting periods (and any extensions thereof) under applicable antitrust laws, and the closing of the Company’s debt refinancing. Contingent consideration payments of up to an additional $20.0 million will be paid upon certain quality and manufacturing qualification requirements (“OEM earnout”) plus an additional $13.0 - $17.0 million upon certain regulatory milestones. Finally the Company will receive amounts equal to 100%, 75%, 50% and 50% of revenue from the sale of the products by Medtronic over each of the four years, respectively, following Medtronic's first commercial sale of a product after the Company's achievement of the OEM earnout. Debt Refinancing The Company has signed a commitment letter to refinance its existing debt facility. The existing debt facility, which has a maturity date of May 20, 2024, will be replaced with a new debt facility in conjunction with the left-heart access portfolio sale. The new debt facility with Deerfield Management Company ("Deerfield") will include $35.0 million in aggregate principal with a maturity date five years from the closing of the loan, as well as amortization payments becoming due at 15% of the principal due at the end of month 36, 15% of the principal due at the end of month 48 and the remaining 70% due at the end of month 60 following the closing of the loan. The new debt facility will bear interest at one-month adjusted term Secured Overnight Financing Rate, with a floor of 2.50% per annum, plus 9.00% per annum. The Company expects to issue warrants to purchase its common stock to Deerfield in connection with the refinancing. Upon the finalization of the left-heart access portfolio, the Company will assess the amount of loss from the extinguishment of the 2019 Credit Agreement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
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, expenses and disclosures of contingent assets and liabilities. The most significant estimates and assumptions in the Company’s condensed consolidated financial statements include, but are not limited to, revenue recognition, useful lives of intangible assets, assessment of impairment of goodwill, measurement of operating lease liabilities, and the fair value of common stock, stock options, warrants, intangible assets and contingent consideration. 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 |
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. |
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 March 31, 2022 and December 31, 2021, exceeded federally insured limits. |
Marketable Securities | Marketable 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 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 investees’ 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 months ended March 31, 2022 and 2021. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | 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. Cash and restricted cash are maintained in accounts with financial institutions which, at times, may exceed the Federal depository insurance coverage of $0.25 million. 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. The Company’s marketable securities portfolio primarily consists of |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company accounts for revenue earned from contracts with customers under 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 if 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, 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 U.S., the Company also has a 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. 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 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, thus the customer obtains control and revenue is recognized at that point in time. Revenue is recognized on delivery for disposable products shipped via 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 sales 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 includes, but is not limited to, transactions where the specific performance obligations are sold separately, list prices and 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 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 March 31, 2022 and December 31, 2021. In May 2020, the Company entered into bi-lateral distribution agreements with Biotronik (the “Bi-Lateral Distribution Agreements”). 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 specified transfer prices 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. |
Inventory | Inventory Inventory is comprised of raw materials, direct labor and manufacturing overhead and 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 based on management’s review of inventories on hand, compared to estimated future usage and sales, shelf-life and assumptions about the likelihood of obsolescence of $1.0 million and $0.1 million for the three months ended March 31, 2022 and 2021, respectively. |
Accounts Receivable | Accounts Receivable 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 March 31, 2022 and December 31, 2021. |
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 Intangible assets consist of acquired developed technology, acquired in-process technology, trademarks and trade names and a customer-related intangible which were acquired as part of the acquisition of Rhythm Xience, Inc. (“Rhythm Xience”) in June 2019. The Company’s intangible assets also include 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 was classified as an indefinite-lived intangible asset, until the receipt of Food and Drug Administration (the “FDA”) approval for the technology in January 2020. Once the FDA approval was received, the in-process technology was classified as a finite-lived intangible and amortization for in-process technology began. 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 quantitative goodwill impairment test. The Company has one reporting unit. For the three months ended March 31, 2022, the Company fully impaired its goodwill balance of $12.0 million. Refer to Note 8 - Goodwill and Intangible Assets |
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 months ended March 31, 2022 and 2021, 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. |
Lessee Leases | Lessee Leases The Company accounts for its lessee leases 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 sheet 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. 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 elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the guidance as an accounting policy election. |
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 The Company is 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. In April 2021, the Company and Biotronik entered into a Feasibility and Development Agreement to pursue the development of hardware, software and IT infrastructure to implement the Qubic Connect System ("QBS"). The QBS will allow data transfer from multiple diagnostic and therapeutic medical products during an electrophysiology procedure to be aggregated and analyzed for the purposes of designing improved treatment protocols. 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 (“SG&A”) 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. The Company expenses all SG&A costs as incurred. |
Restructure | Restructuring Restructuring expense consists of severance expenses related to employees affected by the organizational RIF. The RIF was made to align resources with the Company's current strategic direction. |
Employer Retention Credit | Employee Retention Credit The Coronavirus Aid, Relief and Economic Security (“CARES”) Act provides an employee retention credit (“CARES Employee Retention Credit”), which is a refundable tax credit against certain employment taxes of up to $5 thousand per employee for eligible employers. The tax credit is equal to 50% of qualified wages paid to employees during a quarter, capped at $10 thousand of qualified wages per employee per calendar year through December 31, 2020. Additional relief provisions were passed by the United States government, which extended and expanded the qualified wage caps on these credits through September 30, 2021. Based on these additional provisions, the tax credit is now equal to 70% of qualified wages paid to employees during a quarter beginning with the first quarter of 2021, and the limit on qualified wages per employee has been increased to $10 thousand of qualified wages per quarter instead of per calendar year. The Company qualifies for the tax credit under the CARES Act. The Company filed 2021 Form 941-X Adjusted Employer’s Quarterly Federal Tax Return or Claim for Refund for the quarters ended March 31, 2021 and June 30, 2021 on March 24, 2022. The refunds due are an aggregate of $4.0 million for the quarters ended March 31, 2021 and June 30, 2021. The Company filed its 2020 Form 941-X Adjusted Employer’s Quarterly Federal Tax Return or Claim for Refund for the period March 12, 2020 through December 31, 2020 on March 31, 2022. The refunds due for that period are an aggregate of $0.6 million. The Company elected to classify the ERC amounts as a reduction to payroll tax expense. During the three months ended March 31, 2022, the Company recorded $1.5 million, $1.4 million and $1.7 million related to the CARES Employee Retention Credit within cost of products sold, research and development expense and SG&A expense, respectively, on the Company’s condensed consolidated statement of operations and comprehensive loss. As of March 31, 2022, the Company has a $4.6 million receivable balance from the United States government related to the CARES Act, which is recorded in “Prepaid expenses and other current assets” on the Company’s condensed consolidated balance sheet. |
Fair Value Measurements | Fair Value Measurements 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 has been used in determining the inputs used in 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 that are financial instruments whose values are determined 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 months ended March 31, 2022 and 2021. As of March 31, 2022 and December 31, 2021, 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 the instruments. 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. |
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 awards (“RSAs”), restricted stock units (“RSUs”) and restricted stock units with non-market performance and service conditions (“PSUs”) to be recognized in the condensed 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 RSAs, RSUs and PSUs are valued based on the fair value of the Company’s common stock on the date of grant. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. The Company expenses stock-based compensation related to stock options, RSAs and RSUs over the requisite service period. As the PSUs have a performance condition, compensation expense was recognized for each vesting tranche over the respective requisite service period of each tranche upon the registration statement becoming effective on August 5, 2020, when the Company’s management deemed it probable that the performance conditions were satisfied. The Company recognized a cumulative true-up adjustment related to PSUs once the conditions became probable of being satisfied as the related service period had been completed in a prior 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 also “ Note 15—Stock-Based Compensation ” below. |
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. |
Business Combinations | Business Combinations The Company accounts for business acquisitions using the acquisition method of accounting based on ASC 805, Business Combinations (“ASC 805”), which requires recognition and measurement of all identifiable assets acquired and liabilities assumed at their fair value as of the date control is obtained. The Company determines the fair value of assets acquired and liabilities assumed based upon its best estimates of the acquisition-date fair value of assets acquired and liabilities assumed in the acquisition. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired. Subsequent adjustments to fair value of any contingent consideration are recorded to the Company’s condensed consolidated statements of operations and comprehensive loss. |
Recently Adopted Accounting Pronouncements and Accounting Pronouncements to Be Adopted | Recently Adopted Accounting Pronouncements In May 2021, the FASB issued ASU No. 2021-05 , Leases (Topic 842), Lessors – Certain Leases with Variable Lease Payments, which clarifies that lessors should classify and account for a lease with variable lease payments that do not depend on a reference index or a rate as an operating lease. This ASU is effective for smaller reporting companies in 2022. The Company adopted this guidance in the first quarter of 2022, which did not have a material impact on its condensed consolidated financial statements. In April 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt Modifications and Extinguishments (Subtopic 470-50), Compensation Stock Compensation (Topic 718), and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic 815-40) , which provides clarification on how to account for a modification or exchange of free-standing equity-classified written call options that remain equity classified after the modification or exchange. This ASU is effective for smaller reporting companies in 2022. The Company adopted this guidance in the first quarter of 2022, which did not have a material impact on its condensed consolidated financial statements. Accounting Pronouncements to Be Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326) . The ASU 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. This ASU is effective for smaller reporting companies in 2023. The Company is currently assessing the impact of the adoption of this ASU on its condensed consolidated financial statements. In March 2020, the FASB issued ASU No. 2020-4, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting , which provides temporary optional guidance to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients and exceptions for applying U.S. GAAP to transactions affected by reference rate reform if certain criteria are met. These transactions include contract modifications, hedging relationships and sale or transfer of debt securities classified as held-to-maturity. Entities may apply the provisions of the new standard as of the beginning of the reporting period when the election is made (i.e., as early as the first quarter of 2020). Unlike other topics, the provisions of this update are only available until December 31, 2022, when the reference rate replacement activity is expected to have been completed. The Company is currently evaluating the impact of this standard on its condensed consolidated financial statements and has yet to elect an adoption date. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 shown on the condensed consolidated statement of cash flows (in thousands): March 31, December 31, (unaudited) Cash and cash equivalents $ 12,319 $ 24,071 Restricted cash 150 150 Total cash, cash equivalents and restricted cash $ 12,469 $ 24,221 |
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 shown on the condensed consolidated statement of cash flows (in thousands): March 31, December 31, (unaudited) Cash and cash equivalents $ 12,319 $ 24,071 Restricted cash 150 150 Total cash, cash equivalents and restricted cash $ 12,469 $ 24,221 |
Summary of Disaggregation of Revenue | The following table sets forth the Company’s revenue for disposables, systems and service/other for the three months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) Disposables $ 3,211 $ 2,342 Systems — 969 Service/Other 470 280 Total revenue $ 3,681 $ 3,591 |
Summary of Revenue from External Customers by Geographic Areas | The following table provides revenue by geographic location for the three months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) United States $ 2,023 $ 1,581 Outside the United States 1,658 2,010 Total revenue $ 3,681 $ 3,591 |
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 March 31, 2022 and December 31, 2021 (in thousands): Fair Value Measurements as of March 31, 2022 (unaudited) Quoted Significant Significant Fair Value at Assets included in: Cash and cash equivalents Money market securities $ 10,376 $ — $ — $ 10,376 Marketable securities at fair value Corporate debt securities — 4,046 — 4,046 U.S. treasury securities — 5,042 — 5,042 Commercial paper — 36,775 — 36,775 Yankee debt securities — 3,877 — 3,877 Supranational — 3,019 — 3,019 Asset-backed securities — 13,547 — 13,547 Total fair value $ 10,376 $ 66,306 $ — $ 76,682 Liabilities included in: Contingent consideration $ — $ — $ 1,700 $ 1,700 Total fair value $ — $ — $ 1,700 $ 1,700 Fair Value Measurements as of December 31, 2021 Quoted Significant Significant Fair Value at Assets included in: Cash and cash equivalents Money market securities $ 21,893 $ — $ — $ 21,893 Marketable securities at fair value Corporate debt securities — 18,860 — 18,860 U.S. treasury securities — 5,064 — 5,064 Commercial paper — 36,759 — 36,759 Yankee debt securities — 3,932 — 3,932 Supranational — 3,051 — 3,051 Asset-backed securities — 16,156 — 16,156 Total fair value $ 21,893 $ 83,822 $ — $ 105,715 Liabilities included in: Contingent consideration $ — $ — $ 2,000 $ 2,000 Total fair value $ — $ — $ 2,000 $ 2,000 |
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 three months ended March 31, 2022 (in thousands): Contingent Balance, December 31, 2021 $ 2,000 Payment of contingent consideration (290) Escrow release (1) (17) Change in fair value 7 Balance, March 31, 2022 (unaudited) $ 1,700 (1) As part of the Rhythm Xience acquisition (see Note 3), the first $0.5 million earned related to revenue success payments was paid at the end of the first month following the end of the quarter in which the revenue success payments were earned, into an escrow account until the expiration of an additional 18 month hold-back period commencing with the end of the quarter during which such revenue success payment amounts were earned. Amounts noted above were released from the escrow account. |
Weighted-Average Unobservable Inputs to Measure Contingent Consideration | The weighted average (in aggregate) significant unobservable inputs (Level 3 inputs) used in measuring the contingent consideration from the acquisition of Rhythm Xience as of March 31, 2022 and December 31, 2021 were as follows: March 31, 2022 December 31, 2021 (unaudited) Risk-free interest rate 2.00% 0.60% Expected term in years 1.0 - 2.0 1.0 - 2.0 Expected volatility 25.1% 28.8% |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | Marketable securities consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, 2022 (unaudited) Amortized Gross Gross Fair Value Available-for-sale securities - short-term: Corporate debt securities $ 4,046 $ — $ — $ 4,046 U.S. treasury securities 5,076 — (34) 5,042 Commercial paper 36,775 — — 36,775 Yankee debt securities 3,897 — (20) 3,877 Supranational 3,027 — (8) 3,019 Asset-backed securities, short-term 9,565 — (32) 9,533 Total available-for-sale securities - short-term 62,386 — (94) 62,292 Asset-backed securities, long term 4,022 — (8) 4,014 Total available-for-sale securities $ 66,408 $ — $ (102) $ 66,306 December 31, 2021 Amortized Gross Gross Fair Value Available-for-sale securities - short-term: Corporate debt securities, short-term $ 15,786 $ — $ (6) $ 15,780 U.S. treasury securities 5,073 — (9) 5,064 Commercial paper 36,759 $ — — 36,759 Yankee debt securities 3,941 — (9) 3,932 Supranational 3,054 — (3) 3,051 Asset-backed securities, short-term 12,128 — (12) 12,116 Total available-for-sale securities - short-term 76,741 — (39) 76,702 Corporate debt securities, long-term 3,082 — (2) 3,080 Asset-backed securities, long-term 4,044 — (4) 4,040 Total available-for-sale securities - long-term 7,126 — (6) 7,120 Total available-for-sale securities $ 83,867 $ — $ (45) $ 83,822 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Summary of Inventory | Inventory as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands): March 31, December 31, (unaudited) Raw materials $ 7,898 $ 6,779 Work in process 2,181 1,772 Finished goods 7,541 7,857 Total inventory $ 17,620 $ 16,408 |
Lessor Sales-Type Leases (Table
Lessor Sales-Type Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Estimated Future Maturities of Sales-Type Lease Receivables | As of March 31, 2022, estimated future maturities of sales-type lease receivables for each of the following years are as follows (in thousands): Nine months ending December 31, 2022 $ 637 Year ending December 31, 2023 434 Year ending December 31, 2024 253 Year ending December 31, 2025 50 Year ending December 31, 2026 — Lease receivable $ 1,374 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, Net | The Company’s property and equipment, net, consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, December 31, (unaudited) Medical diagnostic equipment $ 17,330 $ 16,759 Furniture and fixtures 433 433 Office equipment 1,573 1,538 Laboratory equipment and software 5,320 5,302 Leasehold improvements 580 582 Construction in process 1,083 958 Total property and equipment 26,319 25,572 Less: accumulated depreciation (13,357) (11,902) Property and equipment, net $ 12,962 $ 13,670 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Goodwill and Intangible Assets Activities | The table below summarizes goodwill and intangible assets activities as of March 31, 2022 and December 31, 2021 (in thousands): Goodwill Intangible Balance, December 31, 2021 $ 12,026 $ 5,013 Amortization expense — (160) Goodwill impairment (12,026) — Balance, March 31, 2022 (unaudited) $ — $ 4,853 |
Summary of Finite Lived Intangible Assets | Estimated Weighted Intangible Accumulated March 31, (unaudited) Developed technology 10.0 7.3 $ 4,200 $ (1,125) $ 3,075 Customer-related intangible 5.0 2.3 100 (55) 45 Licensed intangibles 10.0 8.7 2,000 (267) 1,733 Total $ 6,300 $ (1,447) $ 4,853 Estimated Weighted Intangible Accumulated December 31, 2021 Developed technology 10.0 7.6 $ 4,200 $ (1,020) $ 3,180 Customer-related intangible 5.0 2.5 100 (50) 50 Licensed intangibles 10.0 8.9 2,000 (217) 1,783 Total $ 6,300 $ (1,287) $ 5,013 |
Summary of Remaining Amortization Expense | The following table shows the remaining amortization expense associated with amortizable intangible assets as of March 31, 2022 (in thousands): Developed Customer- Licensed Total Nine months ending December 31, 2022 $ 315 $ 15 $ 150 $ 480 Year ending December 31, 2023 420 20 200 640 Year ending December 31, 2024 420 10 200 630 Year ending December 31, 2025 420 — 200 620 Year ending December 31, 2026 420 — 200 620 Thereafter 1,080 — 783 1,863 Total $ 3,075 $ 45 $ 1,733 $ 4,853 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following as of March 31, 2022 and December 31, 2021 (in thousands): March 31, December 31, (unaudited) Compensation and related expenses $ 7,304 $ 7,088 Professional fees 857 158 Deferred revenue 430 401 Sales and use tax 190 71 Clinical studies 483 541 Clinician Council payable 376 358 Accrued royalties 239 129 Accrued restructuring 394 — Other 359 350 Total accrued liabilities $ 10,632 $ 9,096 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Outstanding Debt | Outstanding debt as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands): March 31, December 31, (unaudited) 2019 Credit Agreement (1) $ 44,550 $ 44,550 Total debt, gross 44,550 44,550 Less: Unamortized debt discount and fees (3,757) (4,135) Total long-term debt $ 40,793 $ 40,415 (1) The 2019 Credit Agreement includes final payment fees of $4.6 million. |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 three months ended March 31, 2022 and 2021 (dollars in thousands): Three Months Ended March 31, 2022 Three Months Ended March 31, 2021 (unaudited) Operating cash flows from operating leases $ 98 $ 261 Weighted average remaining lease term – operating leases (in years) 3.4 1.4 Weighted average discount rate – operating leases 7.0 % 7.0 % The following table provides the components of the Company’s lease cost (in thousands): Three Months Ended March 31, 2022 Three Months Ended March 31, 2021 (unaudited) Operating leases Operating lease cost $ 247 $ 216 Variable lease cost 77 83 Total rent expense $ 324 $ 299 |
Summary of Future Minimum Payments Under the Non-cancelable Operating Leases | As of March 31, 2022, future minimum payments under the non-cancelable operating leases under ASC 842 were as follows (in thousands): Nine months ending December 31, 2022 $ 806 Year ending December 31, 2023 1,135 Year ending December 31, 2024 1,167 Year ending December 31, 2025 1,151 Year ending December 31, 2026 1,185 Thereafter 1,221 Total 6,665 Less: present value discount (1,693) Operating lease liabilities $ 4,972 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Schedule of Outstanding Warrants to Purchase the Company's Common Stock | As of March 31, 2022 and December 31, 2021, the outstanding warrants to purchase the Company’s common stock were comprised of the following: Equity Upon Exercise Price Expiration Date March 31, December 31, (unaudited) Warrants issued in 2015 Common stock $ 5.25 1/30/25 3,808 3,808 Warrants issued with 2018 Convertible Notes Common stock $ 0.10 6/7/28 346,689 346,689 Warrants issued with 2018 Term Loan Common stock $ 16.67 7/31/28 26,998 26,998 Warrants issued with 2019 Credit Agreement Common stock $ 16.67 5/20/29 419,992 419,992 Total Warrants 797,487 797,487 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 three months ended March 31, 2022 and 2021: Three Months Ended March 31, 2022 2021 (unaudited) Risk-free interest rate 1.76% 0.76% - 1.28% Expected dividend yield — — Expected term in years 6.0 7.0 Expected volatility 75% 60% - 75% |
Summary of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2022: Stock Weighted Weighted Aggregate Outstanding as of December 31, 2021 3,781,636 $ 13.12 7.6 $ 93 Options granted 562,250 2.41 Options exercised (35,478) 1.85 $ 310 Options forfeited (287,049) 8.30 Outstanding as of March 31, 2022 (unaudited) 4,021,359 $ 12.07 7.7 $ — Options vested and exercisable as of March 31, 2022 (unaudited) 1,733,894 $ 12.55 6.5 $ — |
Schedule of PSU and RSU Activity | The Company’s PSU and RSU activity for the three months ended March 31, 2022 was as follows: Number Weighted Unvested as of December 31, 2021 995,091 $ 13.47 Granted 1,045,586 2.41 Forfeited (128,771) 8.94 Vested (193,555) 13.67 Unvested as of March 31, 2022 (unaudited) 1,718,351 $ 7.06 |
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 months ended March 31, 2022 and 2021 (in thousands): Three Months Ended March 31, 2022 2021 (unaudited) Cost of products sold $ 226 $ 157 Research and development 514 442 Selling, general and administrative 2,292 2,311 Total stock-based compensation $ 3,032 $ 2,910 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Calculation of the Diluted Net Loss per Common Share | 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: Three Months Ended March 31, Shares issuable upon: 2022 2021 (unaudited) Conversion of Series A Common Equivalent Preferred Stock 6,665,841 — Exercise of stock options 4,021,359 3,379,575 Exercise of common stock warrants 797,487 824,608 Vesting of PSUs and RSUs 1,718,351 466,785 Total 13,203,038 4,670,968 |
Organization and Description _2
Organization and Description of Business (Details) $ / shares in Units, $ in Thousands | Aug. 10, 2020USD ($)$ / sharesshares | Jul. 28, 2020 | Jul. 31, 2021USD ($)$ / sharesshares | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Subsidiary, Sale of Stock [Line Items] | |||||||
Cash, cash equivalents, and short-term investments | $ 78,600 | $ 107,900 | |||||
Net loss | 40,017 | $ 29,181 | 117,700 | $ 102,000 | |||
Net cash used in operating activities | 27,609 | $ 26,273 | |||||
Accumulated deficit | 518,715 | 478,698 | |||||
Working Capital | $ 87,100 | $ 107,800 | |||||
Proceeds from sale of convertible preferred stock and convertible debt | $ 253,900 | ||||||
Reverse stock split conversion ratio | 0.102838 | ||||||
Stock issued during period (in shares) | shares | 6,325,000 | ||||||
Proceeds from the issuance of common stock, net of issuance costs | $ 82,700 | ||||||
IPO | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Stock issued during period (in shares) | shares | 10,147,058 | ||||||
Price per share (in dollars per share) | $ / shares | $ 18 | ||||||
Proceeds from issuance, initial public offering | $ 166,300 | ||||||
Over-Allotment Option | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Stock issued during period (in shares) | shares | 1,323,529 | 825,000 | |||||
Price per share (in dollars per share) | $ / shares | $ 14 | ||||||
Public Stock Offering | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Consideration received on transaction | $ 88,600 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | ||
Mar. 31, 2022USD ($)segmentreportingUnit | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segment | segment | 1 | ||
Other-than-temporary impairments related to marketable securities | $ 0 | $ 0 | |
Cash, FDIC insured amount | 250,000 | ||
Inventory write-down | 1,000,000 | 100,000 | |
Allowance for uncollectible accounts | $ 0 | $ 0 | |
Number of reporting unit | reportingUnit | 1 | ||
Goodwill impairment | $ 12,026,000 | 0 | |
Impairment of property and equipment or intangible assets | 0 | 0 | |
Selling, general and administrative | 14,385,000 | 16,252,000 | |
Research and development | 8,003,000 | $ 9,370,000 | |
Prepaid expenses and other current assets | 9,064,000 | $ 5,326,000 | |
Interest or penalties charged in relation to the unrecognized tax benefits | 0 | ||
CARES Employee Retention Credit | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cost of products sold | 1,500,000 | ||
Selling, general and administrative | 1,400,000 | ||
Research and development | 1,700,000 | ||
Prepaid expenses and other current assets | 4,600,000 | ||
Tax Year 2021 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Income taxes receivable | 4,000,000 | ||
Tax Year 2020 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Income taxes receivable | $ 600,000 | ||
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Customers payment period | 30 days | ||
Property and equipment, estimated useful lives | 3 years | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Customers payment period | 60 days | ||
Contracts with customers, expected duration | 1 year | ||
Property and equipment, estimated useful lives | 5 years | ||
Deferred Equipment Agreements | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Up-front charge | $ 0 | ||
Deferred Equipment Agreements | Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Contract term | 2 years | ||
Deferred Equipment Agreements | Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Contract term | 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 | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 12,319 | $ 24,071 | ||
Restricted cash | 150 | 150 | ||
Total cash, cash equivalents and restricted cash | $ 12,469 | $ 24,221 | $ 8,781 | $ 25,384 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 3,681 | $ 3,591 |
Disposables | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 3,211 | 2,342 |
Systems | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 0 | 969 |
Service/Other | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 470 | $ 280 |
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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 3,681 | $ 3,591 |
United States | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,023 | 1,581 |
Outside the United States | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 1,658 | $ 2,010 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Fair Value, Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Assets included in: | ||
Available-for-sale securities | $ 66,306 | $ 83,822 |
Total fair value | 76,682 | 105,715 |
Liabilities included in: | ||
Total fair value | 1,700 | 2,000 |
Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 1,700 | 2,000 |
Money market securities | ||
Assets included in: | ||
Money market securities | 10,376 | 21,893 |
Corporate debt securities | ||
Assets included in: | ||
Available-for-sale securities | 4,046 | 18,860 |
U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 5,042 | 5,064 |
Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 36,775 | 36,759 |
Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 3,877 | 3,932 |
Supranational | ||
Assets included in: | ||
Available-for-sale securities | 3,019 | 3,051 |
Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | 13,547 | 16,156 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets included in: | ||
Total fair value | 10,376 | 21,893 |
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 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market securities | ||
Assets included in: | ||
Money market securities | 10,376 | 21,893 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Corporate debt securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
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) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Supranational | ||
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 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Assets included in: | ||
Total fair value | 66,306 | 83,822 |
Liabilities included in: | ||
Total fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Money market securities | ||
Assets included in: | ||
Money market securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Corporate debt securities | ||
Assets included in: | ||
Available-for-sale securities | 4,046 | 18,860 |
Significant Other Observable Inputs (Level 2) | U.S. treasury securities | ||
Assets included in: | ||
Available-for-sale securities | 5,042 | 5,064 |
Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Assets included in: | ||
Available-for-sale securities | 36,775 | 36,759 |
Significant Other Observable Inputs (Level 2) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 3,877 | 3,932 |
Significant Other Observable Inputs (Level 2) | Supranational | ||
Assets included in: | ||
Available-for-sale securities | 3,019 | 3,051 |
Significant Other Observable Inputs (Level 2) | Asset-backed securities | ||
Assets included in: | ||
Available-for-sale securities | 13,547 | 16,156 |
Significant Unobservable Inputs (Level 3) | ||
Assets included in: | ||
Total fair value | 0 | 0 |
Liabilities included in: | ||
Total fair value | 1,700 | 2,000 |
Significant Unobservable Inputs (Level 3) | Contingent consideration | ||
Liabilities included in: | ||
Total fair value | 1,700 | 2,000 |
Significant Unobservable Inputs (Level 3) | Money market securities | ||
Assets included in: | ||
Money market securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Corporate debt securities | ||
Assets included in: | ||
Available-for-sale 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) | Yankee debt securities | ||
Assets included in: | ||
Available-for-sale securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Supranational | ||
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 | $ 0 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Contingent Consideration | ||
Change in fair value | $ 7 | $ (1,153) |
Contingent consideration | ||
Contingent Consideration | ||
Additional holdback period | 18 months | |
Significant Unobservable Inputs (Level 3) | Contingent consideration | ||
Contingent Consideration | ||
Balance at beginning of period | $ 2,000 | |
Payment of contingent consideration | (290) | |
Escrow release | (17) | |
Change in fair value | 7 | |
Balance at end of period (unaudited) | 1,700 | |
Revenue success payments | $ 500 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Weighted-Average Fair Value Assumptions on Contingent Consideration (Details) - Significant Unobservable Inputs (Level 3) - Rhythm Xience | Mar. 31, 2022 | Dec. 31, 2021 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration from the acquisition, Fair value inputs | 0.0200 | 0.0060 |
Expected term in years | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration from the acquisition, Fair value inputs | 1 | 1 |
Expected term in years | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration from the acquisition, Fair value inputs | 2 | 2 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Contingent consideration from the acquisition, Fair value inputs | 0.251 | 0.288 |
Asset Acquisition and Busines_2
Asset Acquisition and Business Combination (Details) - USD ($) $ in Thousands | Jun. 18, 2019 | Feb. 29, 2020 | Jul. 31, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Business Acquisition [Line Items] | |||||||||
Research and development | $ 8,003 | $ 9,370 | |||||||
Payments for contingent consideration | 290 | 2,547 | |||||||
Biotronik Asset Acquisition | |||||||||
Business Acquisition [Line Items] | |||||||||
Consideration paid in cash | $ 10,000 | ||||||||
Equity interests issued and issuable | $ 5,000 | ||||||||
Consideration transferred | $ 15,000 | ||||||||
Payments for contingent consideration | 2,000 | ||||||||
Accrued liabilities (less than) | 100 | ||||||||
Contingent milestone and royalty payments | 8,000 | $ 8,000 | |||||||
Potential milestone payments capitalized | $ 2,000 | ||||||||
Biotronik Asset Acquisition | Maximum | |||||||||
Business Acquisition [Line Items] | |||||||||
Potential milestone payments payable | 10,000 | ||||||||
Biotronik Asset Acquisition | Intellectual Property | |||||||||
Business Acquisition [Line Items] | |||||||||
Research and development | $ 15,000 | ||||||||
Rhythm Xience | |||||||||
Business Acquisition [Line Items] | |||||||||
Consideration paid in cash | $ 3,000 | ||||||||
Payments for contingent consideration | 300 | 2,500 | |||||||
Contingent consideration liability | 13,400 | 1,700 | $ 3,400 | ||||||
Contingent consideration liability increase (decrease) | $ 100 | $ (1,200) | |||||||
Rhythm Xience | Earnout Consideration | |||||||||
Business Acquisition [Line Items] | |||||||||
Potential milestone payments payable | $ 17,000 | ||||||||
Series D Convertible Preferred Stock | Biotronik Asset Acquisition | |||||||||
Business Acquisition [Line Items] | |||||||||
Business consideration, number of equity interests issued and issuable (in shares) | 273,070 | ||||||||
Equity interests issued and issuable | $ 5,000 | ||||||||
Series D Convertible Preferred Stock | Rhythm Xience | |||||||||
Business Acquisition [Line Items] | |||||||||
Business consideration, number of equity interests issued and issuable (in shares) | 119,993 | ||||||||
Series D Convertible Preferred Stock | Rhythm Xience | Earnout Consideration | |||||||||
Business Acquisition [Line Items] | |||||||||
Equity interests issued and issuable | $ 2,200 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 66,408 | $ 83,867 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (102) | (45) |
Fair Value | 66,306 | 83,822 |
Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 62,386 | 76,741 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (94) | (39) |
Fair Value | 62,292 | 76,702 |
Long-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 7,126 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (6) | |
Fair Value | 4,000 | 7,120 |
Corporate debt securities | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,046 | 15,786 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | (6) |
Fair Value | 4,046 | 15,780 |
Corporate debt securities | Long-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 3,082 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (2) | |
Fair Value | 3,080 | |
U.S. treasury securities | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 5,076 | 5,073 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (34) | (9) |
Fair Value | 5,042 | 5,064 |
Commercial paper | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 36,775 | 36,759 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 36,775 | 36,759 |
Yankee debt securities | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 3,897 | 3,941 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (20) | (9) |
Fair Value | 3,877 | 3,932 |
Supranational | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 3,027 | 3,054 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (8) | (3) |
Fair Value | 3,019 | 3,051 |
Asset-backed securities | Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 9,565 | 12,128 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (32) | (12) |
Fair Value | 9,533 | 12,116 |
Asset-backed securities | Long-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,022 | 4,044 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (8) | (4) |
Fair Value | $ 4,014 | $ 4,040 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Available-for-sale securities | $ 66,306 | $ 83,822 |
Short-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available-for-sale securities | $ 62,292 | $ 76,702 |
Debt securities, available-for-sale, maturity period | 1 year | 1 year |
Long-term debt | ||
Debt Securities, Available-for-sale [Line Items] | ||
Available-for-sale securities | $ 4,000 | $ 7,120 |
Debt securities, available-for-sale, maturity period | 4 years | 2 years |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 7,898 | $ 6,779 |
Work in process | 2,181 | 1,772 |
Finished goods | 7,541 | 7,857 |
Total inventory | $ 17,620 | $ 16,408 |
Lessor Sales-Type Leases - Narr
Lessor Sales-Type Leases - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Lessor, Lease, Description [Line Items] | |||
Lease revenue | $ 0 | $ 0.9 | |
Prepaid Expenses and Other Current Assets | |||
Lessor, Lease, Description [Line Items] | |||
Lease receivable | 0.7 | $ 0.9 | |
Other Assets | |||
Lessor, Lease, Description [Line Items] | |||
Lease receivable | $ 0.6 | $ 0.7 |
Lessor Sales-Type Leases - Esti
Lessor Sales-Type Leases - Estimated Future Maturities of Sales-Type Lease Receivables (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Leases [Abstract] | |
Nine months ending December 31, 2022 | $ 637 |
Year ending December 31, 2023 | 434 |
Year ending December 31, 2024 | 253 |
Year ending December 31, 2025 | 50 |
Year ending December 31, 2026 | 0 |
Lease receivable | $ 1,374 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 26,319 | $ 25,572 |
Less: accumulated depreciation | (13,357) | (11,902) |
Property and equipment, net | 12,962 | 13,670 |
Medical diagnostic equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 17,330 | 16,759 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 433 | 433 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,573 | 1,538 |
Laboratory equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 5,320 | 5,302 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 580 | 582 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,083 | $ 958 |
Property and Equipment, Net - N
Property and Equipment, Net - Narrative (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 1,567,000 | $ 1,241,000 |
Impairment of property and equipment or intangible assets | $ 0 | $ 0 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Summary of Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Goodwill | ||
Balance at beginning of period | $ 12,026 | |
Goodwill impairment | (12,026) | $ 0 |
Balance at end of period (unaudited) | 0 | |
Intangible Assets | ||
Balance at beginning of period | 5,013 | |
Amortization expense | (160) | $ (160) |
Balance at end of period (unaudited) | $ 4,853 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Narrative (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill impairment | $ 12,026,000 | $ 0 |
Amortization of intangible assets | 160,000 | 160,000 |
Impairment of intangible assets | $ 0 | $ 0 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Summary of Finite and Indefinite Lived Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets | $ 6,300 | $ 6,300 |
Accumulated Amortization | (1,447) | (1,287) |
Finite-lived intangible assets, net | $ 4,853 | $ 5,013 |
Developed technology | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Weighted Average Remaining Life | 7 years 3 months 18 days | 7 years 7 months 6 days |
Intangible Assets | $ 4,200 | $ 4,200 |
Accumulated Amortization | (1,125) | (1,020) |
Finite-lived intangible assets, net | $ 3,075 | $ 3,180 |
Customer-related intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated Useful Life | 5 years | 5 years |
Weighted Average Remaining Life | 2 years 3 months 18 days | 2 years 6 months |
Intangible Assets | $ 100 | $ 100 |
Accumulated Amortization | (55) | (50) |
Finite-lived intangible assets, net | $ 45 | $ 50 |
Licensed intangibles | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Weighted Average Remaining Life | 8 years 8 months 12 days | 8 years 10 months 24 days |
Intangible Assets | $ 2,000 | $ 2,000 |
Accumulated Amortization | (267) | (217) |
Finite-lived intangible assets, net | $ 1,733 | $ 1,783 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets - Summary of Remaining Amortization Expense (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Nine months ending December 31, 2022 | $ 480 | |
Year ending December 31, 2023 | 640 | |
Year ending December 31, 2024 | 630 | |
Year ending December 31, 2025 | 620 | |
Year ending December 31, 2026 | 620 | |
Thereafter | 1,863 | |
Finite-lived intangible assets, net | 4,853 | $ 5,013 |
Developed technology | ||
Finite-Lived Intangible Assets [Line Items] | ||
Nine months ending December 31, 2022 | 315 | |
Year ending December 31, 2023 | 420 | |
Year ending December 31, 2024 | 420 | |
Year ending December 31, 2025 | 420 | |
Year ending December 31, 2026 | 420 | |
Thereafter | 1,080 | |
Finite-lived intangible assets, net | 3,075 | 3,180 |
Customer-related intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Nine months ending December 31, 2022 | 15 | |
Year ending December 31, 2023 | 20 | |
Year ending December 31, 2024 | 10 | |
Year ending December 31, 2025 | 0 | |
Year ending December 31, 2026 | 0 | |
Thereafter | 0 | |
Finite-lived intangible assets, net | 45 | 50 |
Licensed intangibles | ||
Finite-Lived Intangible Assets [Line Items] | ||
Nine months ending December 31, 2022 | 150 | |
Year ending December 31, 2023 | 200 | |
Year ending December 31, 2024 | 200 | |
Year ending December 31, 2025 | 200 | |
Year ending December 31, 2026 | 200 | |
Thereafter | 783 | |
Finite-lived intangible assets, net | $ 1,733 | $ 1,783 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Compensation and related expenses | $ 7,304 | $ 7,088 |
Professional fees | 857 | 158 |
Deferred revenue | 430 | 401 |
Sales and use tax | 190 | 71 |
Clinical studies | 483 | 541 |
Clinician Council payable | 376 | 358 |
Accrued royalties | 239 | 129 |
Accrued restructuring | 394 | 0 |
Other | 359 | 350 |
Total accrued liabilities | $ 10,632 | $ 9,096 |
Debt - Summary of Outstanding D
Debt - Summary of Outstanding Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | May 20, 2019 |
Debt Instrument [Line Items] | |||
Long-term debt, gross | $ 44,550 | $ 44,550 | |
Less: Unamortized debt discount and fees | (3,757) | (4,135) | |
Total long-term debt | 40,793 | 40,415 | |
2019 Credit Agreement | |||
Debt Instrument [Line Items] | |||
Long-term debt, gross | 44,550 | 44,550 | |
Fee amount | $ 4,600 | $ 4,600 | $ 4,600 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | May 20, 2019 | Mar. 31, 2022 | Dec. 31, 2021 |
2019 Credit Agreement | |||
Debt Instrument [Line Items] | |||
Interest rate | 7.75% | ||
Fee amount | $ 4,600,000 | $ 4,600,000 | $ 4,600,000 |
Warrants liability fair value | 900,000 | ||
Direct fees | $ 1,200,000 | ||
2019 Credit Agreement | Series C Convertible Preferred Stock | |||
Debt Instrument [Line Items] | |||
Class of warrants number of securities called by the warrants or rights (in shares) | 419,992 | ||
Class of warrants, exercise price (in dollars per share) | $ 16.67 | ||
2019 Credit Agreement | Series D Convertible Preferred Stock | |||
Debt Instrument [Line Items] | |||
Class of warrants, exercise price (in dollars per share) | $ 16.67 | ||
2019 Credit Agreement | Senior Term Loan | |||
Debt Instrument [Line Items] | |||
Face amount | $ 70,000,000 | ||
Proceeds from senior term loan | 40,000,000 | ||
Remaining amount | 30,000,000 | ||
Unused borrowing capacity | 0 | ||
Fee amount | 4,600,000 | ||
Initial debt discount before inception | $ 6,700,000 | ||
Default Event | Senior Term Loan | |||
Debt Instrument [Line Items] | |||
Interest rate, increase (decrease) | 10.00% |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Mar. 31, 2022ft² |
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 lease, renewal term | 3 years |
Operating Leases - Summary of Q
Operating Leases - Summary of Quantitative Information About Operating Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Lessee Disclosure [Abstract] | ||
Operating cash flows from operating leases | $ 98 | $ 261 |
Weighted average remaining lease term – operating leases | 3 years 4 months 24 days | 1 year 4 months 24 days |
Weighted average discount rate – operating leases | 7.00% | 7.00% |
Operating Leases - Summary of C
Operating Leases - Summary of Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating leases | ||
Operating lease cost | $ 247 | $ 216 |
Variable lease cost | 77 | 83 |
Total rent expense | $ 324 | $ 299 |
Operating Leases - Summary of F
Operating Leases - Summary of Future Minimum Payments Under the Non-Cancelable Operating Leases (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
Nine months ending December 31, 2022 | $ 806 |
Year ending December 31, 2023 | 1,135 |
Year ending December 31, 2024 | 1,167 |
Year ending December 31, 2025 | 1,151 |
Year ending December 31, 2026 | 1,185 |
Thereafter | 1,221 |
Total | 6,665 |
Less: present value discount | (1,693) |
Operating lease liabilities | $ 4,972 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Mar. 31, 2022lawsuit |
Commitments and Contingencies Disclosure [Abstract] | |
Number of class action lawsuits | 2 |
Warrants - Schedule of Outstand
Warrants - Schedule of Outstanding Warrants to Purchase the Company's Common Stock (Details) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Class of Warrant or Right [Line Items] | ||
Warrants outstanding (in shares) | 797,487 | 797,487 |
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 |
Warrants - Narrative (Details)
Warrants - Narrative (Details) $ in Millions | 3 Months Ended | |
Mar. 31, 2022holder | Aug. 10, 2020USD ($) | |
Warrants and Rights Note Disclosure [Abstract] | ||
Common and preferred stock warrant liability | $ | $ 14.5 | |
Number of warrant holders | holder | 4 | |
Maximum percentage of outstanding common stock | 0.049 | |
Maximum percentage of outstanding common stock, notice for increase | 0.099 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) $ / shares in Units, $ in Thousands | Aug. 10, 2020shares | Aug. 31, 2021investor$ / sharesshares | Jul. 31, 2021USD ($)$ / sharesshares | Mar. 31, 2022USD ($)$ / sharesshares | Mar. 31, 2021USD ($)shares | Dec. 31, 2021$ / shares | Aug. 23, 2021$ / 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 | ||||||
Common stock conversion, notice for increase, period | 61 days | ||||||
Maximum percentage of outstanding common stock, notice for increase | 0.099 | ||||||
Stock issued during period (in shares) | 6,325,000 | ||||||
Proceeds from the issuance of common stock, net of issuance costs | $ | $ 82,700 | ||||||
Stock option exercises (in shares) | 35,478 | ||||||
Proceeds from stock options exercises | $ | $ 66 | $ 169 | |||||
Restricted Stock Units (RSUs) | |||||||
Class of Stock [Line Items] | |||||||
Number of shares, vested (in shares) | 192,138 | 94,045 | |||||
Restricted Stock | |||||||
Class of Stock [Line Items] | |||||||
Number of shares, vested (in shares) | 0 | 186 | |||||
Common Stock | |||||||
Class of Stock [Line Items] | |||||||
Stock option exercises (in shares) | 35,478 | 27,509 | |||||
Employee stock purchase plan shares issued (in shares) | 94,226 | 0 | |||||
Common Stock | |||||||
Class of Stock [Line Items] | |||||||
Conversion of stock, shares converted (in shares) | 6,665,841 | ||||||
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 | $ 0.001 | |||||
Preferred stock, liquidation preference (in dollars per share) | $ / shares | $ 0.001 | ||||||
Conversion of stock, option to convert to common stock (in shares) | 1,000 | ||||||
Over-Allotment Option | |||||||
Class of Stock [Line Items] | |||||||
Stock issued during period (in shares) | 1,323,529 | 825,000 | |||||
Price per share (in dollars per share) | $ / shares | $ 14 | ||||||
Public Stock Offering | |||||||
Class of Stock [Line Items] | |||||||
Consideration received on transaction | $ | $ 88,600 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Aug. 05, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Expected dividend yield | 0.00% | 0.00% | |||
Fair value exercise price to calculate aggregate intrinsic value of options (in dollars per share) | $ 1.39 | $ 3.41 | |||
Share based compensation by share based payment arrangement weighted-average grant date fair value per share of stock option grants (in dollars per share) | $ 1.59 | ||||
Unrecognized compensation related to stock options not vested | $ 25.3 | ||||
Share based compensation non vested award period for recognition | 2 years 2 months 12 days | ||||
Performance Based Restricted Stock Units | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based compensation by share based payment arrangement instruments other than options granted (in shares) | 567,509 | 1,045,586 | |||
Share based compensation by share based payment arrangement instruments other than options granted weighted average grant date fair value (in dollars per share) | $ 13.37 | $ 2.41 | |||
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 | ||||
2020 Plan | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 4,431,305 | ||||
Share based payment arrangement number of shares available for issuance (in shares) | 1,005,667 | ||||
2011 Plan | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Share based payment arrangement, shares authorized for issuance (in shares) | 1,873,625 | ||||
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) | 645,105 | ||||
2020 ESPP | Maximum | |||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||||
Participants purchase price of common stock | 85.00% |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Estimate of the Fair Value of Stock Option (Details) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.76% | |
Risk-free interest rate, minimum | 0.76% | |
Risk-free interest rate, maximum | 1.28% | |
Expected dividend yield | 0.00% | 0.00% |
Expected term | 7 years | |
Expected volatility, minimum | 75.00% | 60.00% |
Expected volatility, maximum | 75.00% | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Stock Options | ||
Outstanding at beginning of period (in shares) | 3,781,636 | |
Options granted (in shares) | 562,250 | |
Options exercised (in shares) | (35,478) | |
Options forfeited (in shares) | (287,049) | |
Outstanding at end of period (unaudited)(in shares) | 4,021,359 | 3,781,636 |
Options vested and exercisable at end of period (unaudited) (in shares) | 1,733,894 | |
Weighted Average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 13.12 | |
Options granted (in dollars per share) | 2.41 | |
Options exercised (in dollars per share) | 1.85 | |
Options forfeited (in dollars per share) | 8.30 | |
Outstanding at end of period (unaudited)(in dollars per share) | 12.07 | $ 13.12 |
Options vested and exercisable at end of period (unaudited) (in dollars per share) | $ 12.55 | |
Stock Options Activity, Additional Disclosures | ||
Weighted average remaining contractual life, Outstanding | 7 years 8 months 12 days | 7 years 7 months 6 days |
Weighted average remaining contractual life, Options vested and exercisable at end of period (unaudited) | 6 years 6 months | |
Aggregate intrinsic value, Outstanding balance at beginning of period | $ 93 | |
Aggregate intrinsic value, Options exercised | 310 | |
Aggregate intrinsic value, Outstanding balance at end of period (unaudited) | 0 | $ 93 |
Aggregate intrinsic value, Options vested and exercisable at end of period (unaudited) | $ 0 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of PSU and RSU Activity (Details) - Performance Based Restricted Stock Units - $ / shares | 1 Months Ended | 3 Months Ended |
Jun. 30, 2019 | Mar. 31, 2022 | |
Number of Shares | ||
Unvested balance at beginning of period (in shares) | 995,091 | |
Granted (in shares) | 567,509 | 1,045,586 |
Forfeited (in shares) | (128,771) | |
Vested (in shares) | (193,555) | |
Unvested balance at end of period (unaudited) (in shares) | 1,718,351 | |
Weighted Average Grant Price | ||
Unvested balance at beginning of period (in dollars per share) | $ 13.47 | |
Granted (in dollars per share) | $ 13.37 | 2.41 |
Forfeited (in dollars per share) | 8.94 | |
Vested (in dollars per share) | 13.67 | |
Unvested balance at end of period (unaudited) (in dollars per share) | $ 7.06 |
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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 3,032 | $ 2,910 |
Cost of products sold | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 226 | 157 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 514 | 442 |
Selling, general and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 2,292 | $ 2,311 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 13,203,038 | 4,670,968 |
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 | 0 |
Exercise of stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 4,021,359 | 3,379,575 |
Exercise of common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 797,487 | 824,608 |
Vesting of PSUs and RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Shares issuable (in shares) | 1,718,351 | 466,785 |
401(k) Retirement Plan (Details
401(k) Retirement Plan (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
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 ($) | 1 Months Ended | 3 Months Ended | ||||
Aug. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Aug. 23, 2021 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | ||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
2019 Credit Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Line of credit cumulative drawdowns till date | $ 40,000,000 | $ 40,000,000 | ||||
Orbimed Royalty Oppurtunities Two LP and Deerfield Private Design Fund LP | 2019 Credit Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Line of credit maximum borrowing capacity | $ 70,000,000 | |||||
Interest expenses related party | 1,400,000 | $ 1,400,000 | ||||
Maximum | Selling, general and administrative | Consulting Agreement | Director and the Chairman | ||||||
Related Party Transaction [Line Items] | ||||||
Consulting fees incurred for related party | $ 100,000 | $ 100,000 | ||||
Common Stock | ||||||
Related Party Transaction [Line Items] | ||||||
Conversion of stock, shares converted (in shares) | 6,665,841 | |||||
Series A Preferred Stock | ||||||
Related Party Transaction [Line Items] | ||||||
Conversion of stock, shares issued (in shares) | 6,666 | |||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | May 12, 2022 | Dec. 31, 2023 |
Subsequent Event | New Debt Facility | Senior Term Loan | ||
Subsequent Event [Line Items] | ||
Face amount | $ 35,000,000 | |
Debt instrument, term | 5 years | |
Subsequent Event | New Debt Facility | Senior Term Loan | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | ||
Subsequent Event [Line Items] | ||
Variable rate, floor | 2.50% | |
Variable rate | 9.00% | |
Subsequent Event | New Debt Facility | Senior Term Loan | Period One | ||
Subsequent Event [Line Items] | ||
Periodic payment, percentage of principal | 15.00% | |
Subsequent Event | New Debt Facility | Senior Term Loan | Period Two | ||
Subsequent Event [Line Items] | ||
Periodic payment, percentage of principal | 15.00% | |
Subsequent Event | New Debt Facility | Senior Term Loan | Period Three | ||
Subsequent Event [Line Items] | ||
Periodic payment, percentage of principal | 70.00% | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | ||
Subsequent Event [Line Items] | ||
Proceeds from divestiture of businesses | $ 50,000,000 | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Year one | ||
Subsequent Event [Line Items] | ||
Milestone consideration, royalty percentage | 100.00% | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Year two | ||
Subsequent Event [Line Items] | ||
Milestone consideration, royalty percentage | 75.00% | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Year three | ||
Subsequent Event [Line Items] | ||
Milestone consideration, royalty percentage | 50.00% | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Year four | ||
Subsequent Event [Line Items] | ||
Milestone consideration, royalty percentage | 50.00% | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Manufacturing Qualification Requirements | ||
Subsequent Event [Line Items] | ||
Compliance consideration amount | $ 20,000,000 | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Regulatory Milestones | Minimum | ||
Subsequent Event [Line Items] | ||
Compliance consideration amount | 13,000,000 | |
Forecast | Disposal Group, Held-for-sale or Disposed of by Sale, Not Discontinued Operations | Left-Heart Access Portfolio | Regulatory Milestones | Maximum | ||
Subsequent Event [Line Items] | ||
Compliance consideration amount | $ 17,000,000 |