Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 10, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-34822 | |
Entity Registrant Name | ClearPoint Neuro, Inc. | |
Entity Central Index Key | 0001285550 | |
Entity Tax Identification Number | 58-2394628 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 120 S. Sierra Ave. | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Solana Beach | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92075 | |
City Area Code | (888) | |
Local Phone Number | 287-9109 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | CLPT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 22,366,804 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 61,524 | $ 20,099 |
Accounts receivable, net | 2,407 | 1,881 |
Inventory, net | 3,575 | 3,238 |
Prepaid expenses and other current assets | 1,003 | 244 |
Total current assets | 68,509 | 25,462 |
Property and equipment, net | 349 | 319 |
Operating lease rights of use | 2,489 | 2,736 |
Software license inventory | 519 | 589 |
Licensing rights | 309 | 353 |
Other assets | 151 | 59 |
Total assets | 72,326 | 29,518 |
Current liabilities: | ||
Accounts payable | 1,252 | 300 |
Accrued compensation | 1,411 | 1,595 |
Other accrued liabilities | 892 | 349 |
Operating lease liabilities, current portion | 462 | 394 |
Deferred product and service revenue | 368 | 562 |
Total current liabilities | 4,385 | 3,200 |
Operating lease liabilities, net of current portion | 2,203 | 2,446 |
Deferred product and service revenue, net of current portion | 268 | 215 |
2020 senior secured convertible notes payable, net | 17,504 | 21,280 |
Total liabilities | 24,360 | 27,141 |
Stockholders’ equity: | ||
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at June 30, 2021 and December 31, 2020 | ||
Common stock, $0.01 par value; 200,000,000 shares authorized; 22,322,344 shares issued and outstanding at June 30, 2021; and 17,047,584 issued and outstanding at December 31, 2020 | 223 | 170 |
Additional paid-in capital | 173,546 | 121,729 |
Accumulated deficit | (125,803) | (119,522) |
Total stockholders’ equity | 47,966 | 2,377 |
Total liabilities and stockholders’ equity | $ 72,326 | $ 29,518 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized | 25,000,000 | 25,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized | 200,000,000 | 200,000,000 |
Common stock, issued | 22,322,344 | 17,047,584 |
Common stock, outstanding | 22,322,344 | 17,047,584 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 3,413 | $ 2,478 | $ 7,443 | $ 5,593 |
Cost of revenues | 1,123 | 802 | 2,539 | 1,733 |
Gross profit | 2,290 | 1,676 | 4,904 | 3,860 |
Research and development costs | 2,123 | 812 | 3,687 | 1,631 |
Sales and marketing expenses | 1,592 | 1,125 | 3,167 | 2,423 |
General and administrative expenses | 1,982 | 1,214 | 3,638 | 2,490 |
Operating loss | (3,407) | (1,475) | (5,588) | (2,684) |
Other income (expense): | ||||
Other (expense) income, net | (96) | 11 | (122) | 6 |
Interest expense, net | (240) | (197) | (571) | (1,038) |
Net loss | $ (3,743) | $ (1,661) | $ (6,281) | $ (3,716) |
Net loss per share attributable to common stockholders: | ||||
Basic and diluted | $ (0.17) | $ (0.11) | $ (0.31) | $ (0.24) |
Weighted average shares used in computing net loss per share: | ||||
Basic and diluted | 21,523,393 | 15,504,169 | 20,195,488 | 15,471,222 |
Product [Member] | ||||
Revenues: | ||||
Total revenues | $ 2,363 | $ 1,636 | $ 5,525 | $ 3,814 |
Service [Member] | ||||
Revenues: | ||||
Total revenues | $ 1,050 | $ 842 | $ 1,918 | $ 1,779 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 152 | $ 117,174 | $ (112,740) | $ 4,586 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2019 | 15,235,308 | |||
Issuances of common stock: | ||||
Share-based compensation | 228 | 228 | ||
Share-based compensation (in shares) | 9,696 | |||
Net loss for the period | (2,055) | (2,055) | ||
Ending balance, value at Mar. 31, 2020 | $ 155 | 117,399 | (114,795) | 2,759 |
Shares, Outstanding, Ending Balance at Mar. 31, 2020 | 15,507,149 | |||
Issuances of common stock: | ||||
Warrant exercises (cashless) | $ 3 | (3) | ||
Warrant exercises (cashless) (in shares) | 262,145 | |||
Beginning balance, value at Dec. 31, 2019 | $ 152 | 117,174 | (112,740) | 4,586 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2019 | 15,235,308 | |||
Issuances of common stock: | ||||
Public offering of common stock | ||||
Net loss for the period | (3,716) | |||
Ending balance, value at Jun. 30, 2020 | $ 155 | 117,640 | (116,456) | 1,339 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 15,512,687 | |||
Beginning balance, value at Mar. 31, 2020 | $ 155 | 117,399 | (114,795) | 2,759 |
Shares, Outstanding, Beginning Balance at Mar. 31, 2020 | 15,507,149 | |||
Issuances of common stock: | ||||
Share-based compensation | 241 | 241 | ||
Share-based compensation (in shares) | 5,538 | |||
Net loss for the period | (1,661) | (1,661) | ||
Ending balance, value at Jun. 30, 2020 | $ 155 | 117,640 | (116,456) | 1,339 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 15,512,687 | |||
Beginning balance, value at Dec. 31, 2020 | $ 170 | 121,729 | (119,522) | 2,377 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2020 | 17,047,584 | |||
Adoption of ASU 2020-06 | (3,107) | (3,107) | ||
Issuances of common stock: | ||||
Public offering of common stock | $ 21 | 46,764 | 46,785 | |
Public offering of common stock (in shares) | 2,127,660 | |||
Share-based compensation | $ 1 | 319 | 320 | |
Share-based compensation (in shares) | 20,709 | |||
Warrant and option exercises (cash and cashless) | $ 15 | 130 | 145 | |
Warrant and option exercises (cash and cashless) (in shares) | 1,482,327 | |||
Net loss for the period | (2,538) | (2,538) | ||
Ending balance, value at Mar. 31, 2021 | $ 207 | 165,835 | (122,060) | 43,982 |
Shares, Outstanding, Ending Balance at Mar. 31, 2021 | 20,678,280 | |||
Beginning balance, value at Dec. 31, 2020 | $ 170 | 121,729 | (119,522) | 2,377 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2020 | 17,047,584 | |||
Adoption of ASU 2020-06 | (3,100) | |||
Issuances of common stock: | ||||
Public offering of common stock | (46,785) | |||
Net loss for the period | (6,281) | |||
Ending balance, value at Jun. 30, 2021 | $ 223 | 173,546 | (125,803) | 47,966 |
Shares, Outstanding, Ending Balance at Jun. 30, 2021 | 22,322,344 | |||
Beginning balance, value at Mar. 31, 2021 | $ 207 | 165,835 | (122,060) | 43,982 |
Shares, Outstanding, Beginning Balance at Mar. 31, 2021 | 20,678,280 | |||
Issuances of common stock: | ||||
Share-based compensation | 247 | 247 | ||
Share-based compensation (in shares) | 26,435 | |||
Warrant and option exercises (cash and cashless) | $ 3 | 346 | 349 | |
Warrant and option exercises (cash and cashless) (in shares) | 361,486 | |||
Net loss for the period | (3,743) | (3,743) | ||
Conversion of 2020 senior secured convertible note | $ 13 | 7,118 | 7,131 | |
Conversion of 2020 senior secured convertible note (in shares) | 1,256,143 | |||
Ending balance, value at Jun. 30, 2021 | $ 223 | $ 173,546 | $ (125,803) | $ 47,966 |
Shares, Outstanding, Ending Balance at Jun. 30, 2021 | 22,322,344 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (6,281) | $ (3,716) |
Adjustments to reconcile net loss to net cash flows from operating activities: | ||
Allowance for doubtful accounts | 92 | 2 |
Depreciation and amortization | 62 | 116 |
Share-based compensation | 567 | 469 |
Payment-in-kind interest | 189 | |
Amortization of debt issuance costs and original issue discounts | 54 | 821 |
Amortization of lease rights of use, net of accretion in lease liabilities | 267 | 50 |
Increase (decrease) in cash resulting from changes in: | ||
Accounts receivable | (617) | (76) |
Inventory, net | (304) | (313) |
Prepaid expenses and other current assets | (760) | (181) |
Other assets | (93) | 70 |
Accounts payable and accrued expenses | 1,312 | 93 |
Accrued interest | (960) | |
Lease liabilities | (195) | (48) |
Deferred revenue | (142) | (366) |
Net cash flows from operating activities | (5,849) | (4,039) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (5) | |
Acquisition of licensing rights | (441) | |
Net cash flows from investing activities | (5) | (441) |
Cash flows from financing activities: | ||
Proceeds from issuance of 2020 senior secured convertible notes, net of financing costs and discount | 16,758 | |
Proceeds from issuance of Paycheck Protection Program loan | 896 | |
Proceeds from public offering of common stock, net of offering costs | 46,785 | |
Proceeds from stock option and warrant exercises | 494 | |
Repayment of notes payable | (2,838) | |
Net cash flows from financing activities | 47,279 | 14,816 |
Net change in cash and cash equivalents | 41,425 | 10,336 |
Cash and cash equivalents, beginning of period | 20,099 | 5,696 |
Cash and cash equivalents, end of period | 61,524 | 16,032 |
Cash paid for: | ||
Income taxes | ||
Interest | $ 353 | $ 1,043 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Statement of Cash Flows [Abstract] | ||
Net transfers of reusable components from loaned systems | $ 30 | $ 50 |
Reduction of additional paid-in capital | 3,100 | |
Conversion of debt | 7,500 | |
Accrued interest included in the conversion of debt | $ 40 | |
Shares issued upon conversion of debt | 1,256,143 | |
Amortization of debt discount | $ 200 |
Description of the Business and
Description of the Business and Financial Condition | 6 Months Ended |
Jun. 30, 2021 | |
Description Of Business And Financial Condition | |
Description of the Business and Financial Condition | 1. Description of the Business and Financial Condition ClearPoint Neuro, Inc. (the “Company”) is a medical device company focused on the development and commercialization of technology that enables physicians to see inside the brain using direct, intra-procedural magnetic resonance imaging (“MRI”) guidance while performing minimally invasive surgical procedures. The Company’s ClearPoint® system, an integrated system comprised of capital equipment and disposable products, is designed to allow minimally invasive procedures in the brain to be performed in an MRI suite. The Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) in 2010 to market the ClearPoint system in the United States for general neurological interventional procedures. COVID-19 In March 2020, the World Health Organization characterized the spread of a novel strain of coronavirus (“COVID-19”) as a global pandemic, and the President of the United States later proclaimed that the COVID-19 outbreak in the United States constituted a national emergency. Extraordinary actions have been taken by federal, state and local governmental authorities to combat the spread of COVID-19, including issuance of “stay-at-home” directives and similar mandates for many individuals to substantially restrict daily activities and for many businesses to curtail or cease normal operations. These measures, while intended to protect human life, led to reduced economic activity, including the postponement or cancellation of elective surgical procedures, which historically have represented approximately 80% of the number of surgical procedures using the Company’s ClearPoint system. Although economic activity is returning to a normalized level, a new Delta variant of COVID-19, which appears to be the most transmissible variant to date, has begun to spread in the United States and across the globe. The impact of the Delta variant cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among the population, the effectiveness of COVID-19 vaccines against the Delta variant and the response by governmental bodies and regulators. Further surges in COVID-19 infection rates could result in the reinstatement of directives and mandates requiring businesses to again curtail or cease normal operations. Furthermore, recessionary conditions caused by the COVID-19 pandemic could have a material adverse effect on the Company’s business, should hospitals postpone or reduce capital purchases and overall spending. Finally, the continuing uncertainty as to whether the federal government will address the resulting fiscal condition in both the near term and long term with measures such as additional fiscal stimulus, as well as other geopolitical issues relating to the global economic slowdown, has increased domestic and global instability. The rapid development and fluidity of the situation preclude any prediction as to the ultimate impact COVID-19 will have on the Company’s business, financial condition, results of operation and cash flows, which will depend largely on future developments directly or indirectly relating to the duration and scope of the COVID-19 outbreak in the United States. Liquidity The Company has incurred net losses since its inception, which has resulted in a cumulative deficit at June 30, 2021 of $ 126 5.8 7.8 In January 2020, the Company entered into a Securities Purchase Agreement (the “SPA”) with two investors (each, a “2020 Convertible Noteholder,” and together, the “2020 Convertible Noteholders”) under which the Company issued an aggregate principal amount of $ 17.5 16.8 five The SPA also gave the Company the right, but not the obligation, to request one of the 2020 Convertible Noteholders to purchase an additional $5.0 million in principal amount of a note (the “Second Closing Note”, and, together with the First Closing Note, the “2020 Secured Notes”). 7.5 In April 2020, the Company received $ 0.9 See Note 5 for additional information with respect to the 2020 Secured Notes. As discussed in Note 7, on February 23, 2021, the Company completed a public offering of 2,127,660 46.8 Based on the foregoing, in management’s opinion, cash and cash equivalent balances at June 30, 2021, are sufficient to support the Company’s operations and meet its obligations for at least the next twelve months. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2020 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with generally accepted accounting principles in the U.S. (“GAAP”). The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2020 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three and six months ended June 30, 2021 may not be indicative of the results to be expected for the entire year or any future periods. Inventory Inventory is carried at the lower of cost (first-in, first-out method) or net realizable value. Items in inventory relate predominantly to the Company’s ClearPoint system. Software license inventory related to ClearPoint systems undergoing on-site customer evaluation is included in inventory in the accompanying condensed consolidated balance sheets. All other software license inventory is classified as a non-current asset. The Company periodically reviews its inventory for obsolete items and provides a reserve upon identification of potential obsolete items. Intangible Assets The Company is a party to certain license agreements that provide rights to the Company for the development and commercialization of products in the functional neurosurgery field. Under the terms of those license agreements, the Company made payments to the licensors upon execution of the license agreements for access to the underlying technologies and will make future payments based on the achievement of regulatory and commercialization milestones as defined in the license agreements. In conformity with Accounting Standards Codification Section 350, “Intangibles – Goodwill and Other,” the Company amortizes its investment in the license rights described above over an expected useful life of five years. In addition, the Company periodically evaluates the recoverability of its investment in the license rights and records an impairment charge in the event such evaluation indicates that the Company’s investment is not likely of being recovered. Revenue Recognition The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of functional neurosurgery, navigation, therapy, and biologics and drug delivery disposable products; (2) product revenue resulting from the sale of ClearPoint capital equipment and software; (3) revenue resulting from the service, installation, training and shipping related to ClearPoint capital equipment and software; and (4) consultation and clinical case support revenue in connection with customer-sponsored clinical trials. The Company recognizes revenue when control of the Company’s products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation customarily charged by the Company. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. Lines of Business; Timing of Revenue Recognition · Functional neurosurgery navigation product, biologics and drug delivery systems product, and therapy product sales: · Capital equipment and software sales o Capital equipment and software sales preceded by evaluation periods: o Capital equipment and software sales not preceded by evaluation periods: For both types of capital equipment and software sales described above, the Company’s determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment. · Therapy services: · Biologics and drug delivery services – Consultation and outsourced technical clinical support of cases performed pursuant to customer-sponsored clinical trials: o Consultation Services: o Service Access Fees: o Procedure-Based Fees: · Capital equipment-related services: o Equipment service: one three o Installation, training and shipping: The Company operates in one Payment terms under contracts with customers generally are in a range of 30-60 days The Company’s terms and conditions do not provide for a right of return unless for: (a) product defects; (b) other conditions subject to the Company’s approval. See Note 3 for additional information regarding revenue recognition. Net Loss Per Share The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which comprise the entire amount of the Company’s outstanding common stock options and warrants, as described in Note 7, and the potential conversion of the First and Second Closing Notes, as described in Note 5, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations. Concentration Risks and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company holds substantially all its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At June 30, 2021, the Company had approximately $ 56.7 At June 30, 2021, there were no customers whose accounts receivable balance exceeded 10% of accounts receivable at that date. At December 31, 2020, one customer accounted for 11 Sales Customer Accounts Receivable One customer, a related party as discussed in Note 3, accounted for 21 26 19 26 Prior to granting credit, the Company performs credit evaluations of its customers’ financial condition, and generally does not require collateral from its customers. The Company will provide an allowance for doubtful accounts when collections become doubtful. The allowance for doubtful accounts at June 30, 2021 and December 31, 2020 was $ 0.1 0.06 The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results. Adoption of New Accounting Standard Effective January 1, 2021, the Company adopted, on a modified retrospective method of transition, the provisions of Accounting Standards Update No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) – Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (the “ASU”). The ASU is effective for public companies, other than smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, and for smaller reporting companies, which is the Company’s current classification, for fiscal years beginning after December 31, 2023. However, the ASU permits early adoption, no earlier than for fiscal years beginning after December 31, 2020, and the Company elected such early adoption. The ASU amends prior authoritative literature to reduce the number of accounting models for, among others, convertible debt instruments for which the embedded conversion features of such instruments had previously been required to be separated from the host contract. The Company determined that the conversion feature embedded in the Second Closing Note (see Note 5) was within the scope of the ASU. Accordingly, the discount originally recorded in connection with the issuance of the Second Closing Note and a corresponding amount recorded in additional paid-in capital, each in the amount of approximately $ 3.1 Reclassifications The accompanying consolidated statement of operations for the three and six months ended June 30, 2021 contains: (a) certain items formerly classified as service revenue that that have been reclassified to product revenue; (b) certain items formerly classified as general and administrative expenses, research and development expenses, and sales and marketing expenses that have been reclassified to cost of revenue; and (c) an item formerly classified as interest expense that has been reclassified as other expense. The accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2020 has been conformed to the 2021 presentation. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | 3. Revenue Recognition Revenue by Service Line Three Months Ended June 30, (in thousands) 2021 2020 Functional neurosurgery navigation and therapy Disposable products $ 1,861 $ 1,071 Biologics and drug delivery Disposable products 450 407 Services 940 761 Subtotal – biologics and drug delivery revenue 1,390 1,168 Capital equipment and software Systems and software products 52 158 Services 110 81 Subtotal – capital equipment and software revenue 162 239 Total revenue $ 3,413 $ 2,478 Six Months Ended June 30, (in thousands) 2021 2020 Functional neurosurgery navigation and therapy Disposable products $ 3,779 $ 2,812 Biologics and drug delivery Disposable products 1,364 580 Services 1,685 1,616 Subtotal – biologics and drug delivery revenue 3,049 2,196 Capital equipment and software Systems and software products 382 422 Services 233 163 Subtotal – capital equipment and software revenue 615 585 Total revenue $ 7,443 $ 5,593 Contract Balances · Contract assets · Contract liabilities – During the three and six months ended June 30, 2021, the Company recognized capital equipment and software-related service revenue of approximately $ 0.09 0.2 In 2019, the Company entered into a Development Services Agreement with a customer under which the Company was entitled to bill the customer for an upfront payment of $ 0.13 0.02 0.05 Commencing in 2019, the Company was a party to a Letter of Intent and a related Statement of Work (together with the Letter of Intent, the “Project Documents”) with a customer who is a stockholder and a noteholder (see Note 5), and an officer of whom is a member of the Company’s Board of Directors, to commence a product development project. Under the terms of the Project Documents, the Company was entitled to bill the customer for: (a) an upfront, nonrefundable payment of $ 0.5 0.5 0.25 0.7 1.5 0.02 0.1 0.04 0.1 The Company offers an upgraded version of its software at no additional charge to customers purchasing a three-year systems service agreement. The transaction prices of the software and the service agreement are determined through an allocation of the service agreement price based on the standalone prices of the software and the service agreements customarily charged by the Company. The transaction price of the software is recognized as revenue upon its installation and comprised approximately $ 0.1 Remaining Performance Obligations The Company’s contracts with customers for functional neurosurgery and therapy product sales are predominantly of terms less than one year. Accordingly, the transaction prices of remaining performance obligations related to such contracts at June 30, 2021 are not material. Revenue with respect to remaining performance obligations related to capital equipment and software-related service agreements with original terms in excess of one year and the upfront payments discussed under the heading “Contract Balances” above amounted to approximately $ 0.6 Revenue with respect to remaining performance obligations related to contracts with the Company’s biologic and drug delivery customers, other than those contracts discussed under the heading “Contract Balances,” predominantly is contingent upon such customers’ performance of clinical trials on which the Company’s performance obligations are predicated. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory Inventory consists of the following as of: Inventory - Schedule of Inventory, Current (in thousands) June 30, December 31, Raw materials and work in process $ 1,764 $ 1,485 Software licenses 245 193 Finished goods 1,566 1,560 Inventory, net, included in current assets 3,575 3,238 Software licenses – non-current 519 589 Total $ 4,094 $ 3,827 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Notes Payable | 5. Notes Payable As a result of the transactions described below, an aggregate principal amount of $ 17.5 At the option of the holders at any time prior to maturity, $10 million in principal amount of the 2020 Secured Convertible Notes are convertible to the Company’s common stock at a conversion price of $6.00, and $7.5 million in principal amount of the 2020 Secured Convertible Notes are convertible at a price of $10.14, subject in both cases to adjustments as set forth in the SPA and the note agreements. On January 29, 2020 (the “Closing Date”), the Company completed a financing transaction (the “2020 Financing Transaction”) with the 2020 Convertible Noteholders, whereby the Company issued an aggregate principal amount of $ 17.5 fifth bear interest at a rate equal to the sum of (i) the greater of (a) the three (3)-month London Interbank Offered Rate (“LIBOR”) and (b) two percent (2%), plus (ii) a margin of 2% on the outstanding balance of the First Closing Notes, payable quarterly on the first business day of each calendar quarter. The First Closing Notes may be converted at a price of $6.00 per share, subject to certain adjustments set forth in the SPA, and may not be pre-paid without the consent of the noteholder, provided that the Company must offer to pre-pay such other noteholder on the same terms and conditions. In May 2021, one of 2020 Convertible Noteholders (the “Converting Noteholder”) converted the entire $ 7.5 0.04 1,256,143 At the Closing Date, the SPA gave the Company the right, but not the obligation, to request at any time on or prior to January 11, 2022, that one of the 2020 Convertible Noteholders purchase an additional $5.0 million in aggregate principal amount of Second Closing Note and an additional $10.0 million in aggregate principal amount of Third Closing Note (as defined in the SPA; together, with the Second Closing Note, the “Additional Convertible Notes”), provided that such 2020 Convertible Noteholder has the right, but not the obligation, to purchase such notes. The Additional Convertible Notes would also mature on the fifth anniversary of the Closing Date. On December 29, 2020, the Company and the 2020 Convertible Noteholders entered into the Amendment to the SPA, the terms of which, among other provisions, provided for: (a) an increase in the principal amount of the Second Closing Note to $7.5 million; (b) a revision of the interest rate to be borne by the Second Closing Note to consist of: (i) cash interest of 2% per annum, payable quarterly; and (ii) payment-in-kind interest of 5% per annum, accruable quarterly as an addition to the unpaid principal balance of the Second Closing Note; and (c) an increase in the conversion price of the Second Closing Notes to $10.14 per share, subject to certain adjustments set forth in the SPA The aggregate carrying amounts of the First Closing Notes in the accompanying June 30, 2021 and December 31, 2020 condensed consolidated balance sheets are presented net of financing costs, comprised of commissions and legal expenses, having an unamortized balance of $ 0.2 0.4 0.2 0.2 The carrying amount of the Second Closing Note in the accompanying December 31, 2020 consolidated balance sheet is presented net of a discount, amounting to approximately $ 3.1 14.34 Under the terms of the SPA, as amended, the Company retains the right, but not the obligation, to request the 2020 Convertible Noteholder to purchase the Third Closing Note, and the 2020 Convertible Noteholder has the right, but not the obligation, to purchase such note. As of June 30, 2021, the Company had not made such a request. The 2020 Secured Notes are secured by all the assets of the Company. An executive officer of one of the 2020 Convertible Noteholders is a member of the Company’s Board of Directors. Pursuant to the terms of the SPA and a Board Observer Agreement entered into by the other 2020 Convertible Noteholder and the Company, the other 2020 Convertible Noteholder appointed a representative to attend and observe meetings of the Company’s Board of Directors. On February 25, 2021, such 2020 Convertible Noteholder terminated the Board Observer Agreement, thus precluding its representative from attending future meetings of the Company’s Board of Directors. 2010 Junior Secured Notes Payable On January 27, 2020, as a condition to completion of the 2020 Financing Transaction, the Company entered into the Fourth Omnibus Amendment to notes the 2010 Secured Notes, whereby the 2010 Secured Notes were subordinated to the Company’s obligations under the terms of the 2020 Secured Notes and the Additional Convertible Notes, as applicable. During the first fiscal quarter of 2020, the Company repaid in full the aggregate outstanding principal amount of the 2010 Secured Notes, amounting to approximately $ 2.8 0.9 Scheduled Notes Payable Maturities Scheduled principal payments as of June 30, 2021 with respect to notes payable are summarized as follows: Notes Payable - Schedule of Notes Payable Maturities Year ending December 31, (in thousands) 2025 $ 17,692 Total scheduled principal payments 17,692 Less: Unamortized financing costs (188 ) Total $ 17,504 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | 6. Leases The Company leases office space in Irvine, California that houses office space and a manufacturing facility under a non-cancellable operating lease. The lease term commenced on October 1, 2018 September 2023 five December 15, 2020 December 31, 2026 five The lease cost, included in general and administrative expense, was $ 0.1 0.03 0.3 0.06 |
Stockholders_ Equity
Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | 7. Stockholders’ Equity 2021 Public Offering Public Offering On February 23, 2021, the Company completed a public offering of 2,127,660 1,850,140 23.50 277,520 22.09 Net proceeds from the offering totaled approximately $ 46.8 The underwriting agreement contains representations, warranties, agreements and indemnification obligations by the Company that are customary for this type of transaction. Issuance of Common Stock in Lieu of Cash Payments Under the terms of the Amended and Restated Non-Employee Director Compensation Plan, each compensated non-employee member of the Company’s Board of Directors may elect to receive all or part of his or her director fees in shares of the Company’s common stock. Director fees, whether paid in cash or in shares of common stock, are payable quarterly on the last day of each fiscal quarter. The number of shares of common stock issued to directors is determined by dividing the product of: (i)(a) the fees otherwise payable to each director in cash, times (b) the percentage of fees the director elected to receive in shares of common stock, by (ii) the volume weighted average price per share of common stock over the last five trading days of the quarter. The following is information regarding the number of shares issued to directors as payment for director fees in lieu of cash for the three and six months ended June 30, 2021 and 2020: Stockholders’ Equity - Schedule of Share-Based Compensation for Director Fees Three Months Ended June 30, 2021 2020 1,820 9,832 Six Months Ended June 30, 2021 2020 3,829 19,563 Stock Incentive Plans The Company has various share-based compensation plans and share-based compensatory contracts (collectively, the “Plans”) under which it has granted share-based awards, such as stock grants, and incentive and non-qualified stock options, to employees, directors, consultants and advisors. Awards may be subject to a vesting schedule as set forth in individual award agreements. Certain of the Plans also have provided for cash-based performance bonus awards. From October 2017 until June 2020, the Company granted share-based awards under the Company’s Second Amended and Restated 2013 Incentive Compensation Plan (the “Second Amended Plan”). On June 2, 2020, the Company’s stockholders approved the Company’s Third Amended and Restated 2013 Incentive Compensation Plan (the “Third Amended Plan” and, together with the Second Amended Plan, the “2013 Plan”), under which 1.0 2,956,250 440,995 1,175,679 1,339,576 Stock option activity under all of the Company’s Plans during the six months ended June 30, 2021 is summarized below: Stockholders’ Equity - Schedule of Stock Option Activity Shares Weighted-average Exercise price per share Intrinsic (1) (in thousands) Outstanding at January 1, 2021 1,806,092 $ 7.12 $ 20,760 Granted 40,030 20.61 Exercised 447,900 2.59 Expired / terminated 18,500 20.46 Outstanding at June 30, 2021 1,379,722 $ 8.19 $ 14,916 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. As of June 30, 2021, there was unrecognized compensation expense of approximately $ 2.4 1.8 ESPP On June 3, 2021, the Company’s stockholders adopted and approved the ClearPoint Neuro, Inc. Employee Stock Purchase Plan (the “ESPP”), which allows eligible employees to acquire shares of the Company’s common stock through payroll deductions at a discount to market price. A total of 400,000 Warrants Warrants have generally been issued in connection with financing transactions and for terms of up to five years. Common stock warrant activity for the six months ended June 30, 2021 was as follows: Stockholders’ Equity - Schedule of Common Stock Warrant Activity Shares Weighted-average Exercise price per share Intrinsic (1) (in thousands) Outstanding at January 1, 2021 3,082,987 $ 3.82 $ 37,379 Exercised (1,593,971 ) 3.07 Outstanding at June 30, 2021 1,489,016 $ 4.62 $ 21,653 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis consistent with the Company’s December 31, 2020 audited consolidated financial statements, and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly state the information set forth therein. These condensed consolidated financial statements have been prepared in accordance with SEC rules for interim financial information, and, therefore, omit certain information and footnote disclosures necessary to present such statements in accordance with generally accepted accounting principles in the U.S. (“GAAP”). The preparation of these condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2020 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for a complete set of financial statements. The results of operations for the three and six months ended June 30, 2021 may not be indicative of the results to be expected for the entire year or any future periods. |
Inventory | Inventory Inventory is carried at the lower of cost (first-in, first-out method) or net realizable value. Items in inventory relate predominantly to the Company’s ClearPoint system. Software license inventory related to ClearPoint systems undergoing on-site customer evaluation is included in inventory in the accompanying condensed consolidated balance sheets. All other software license inventory is classified as a non-current asset. The Company periodically reviews its inventory for obsolete items and provides a reserve upon identification of potential obsolete items. |
Intangible Assets | Intangible Assets The Company is a party to certain license agreements that provide rights to the Company for the development and commercialization of products in the functional neurosurgery field. Under the terms of those license agreements, the Company made payments to the licensors upon execution of the license agreements for access to the underlying technologies and will make future payments based on the achievement of regulatory and commercialization milestones as defined in the license agreements. In conformity with Accounting Standards Codification Section 350, “Intangibles – Goodwill and Other,” the Company amortizes its investment in the license rights described above over an expected useful life of five years. In addition, the Company periodically evaluates the recoverability of its investment in the license rights and records an impairment charge in the event such evaluation indicates that the Company’s investment is not likely of being recovered. |
Revenue Recognition | Revenue Recognition The Company’s revenue is comprised primarily of: (1) product revenue resulting from the sale of functional neurosurgery, navigation, therapy, and biologics and drug delivery disposable products; (2) product revenue resulting from the sale of ClearPoint capital equipment and software; (3) revenue resulting from the service, installation, training and shipping related to ClearPoint capital equipment and software; and (4) consultation and clinical case support revenue in connection with customer-sponsored clinical trials. The Company recognizes revenue when control of the Company’s products and services is transferred to its customers in an amount that reflects the consideration the Company expects to receive from its customers in exchange for those products and services, in a process that involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, the Company allocates the contract price among the performance obligations based on the relative stand-alone prices for each such performance obligation customarily charged by the Company. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. Lines of Business; Timing of Revenue Recognition · Functional neurosurgery navigation product, biologics and drug delivery systems product, and therapy product sales: · Capital equipment and software sales o Capital equipment and software sales preceded by evaluation periods: o Capital equipment and software sales not preceded by evaluation periods: For both types of capital equipment and software sales described above, the Company’s determination of the point in time at which to recognize revenue represents that point at which the customer has legal title, physical possession, and the risks and rewards of ownership, and the Company has a present right to payment. · Therapy services: · Biologics and drug delivery services – Consultation and outsourced technical clinical support of cases performed pursuant to customer-sponsored clinical trials: o Consultation Services: o Service Access Fees: o Procedure-Based Fees: · Capital equipment-related services: o Equipment service: one three o Installation, training and shipping: The Company operates in one Payment terms under contracts with customers generally are in a range of 30-60 days The Company’s terms and conditions do not provide for a right of return unless for: (a) product defects; (b) other conditions subject to the Company’s approval. See Note 3 for additional information regarding revenue recognition. |
Net Loss Per Share | Net Loss Per Share The Company computes net loss per share using the weighted-average number of common shares outstanding during the period. Basic and diluted net loss per share are the same because the conversion, exercise or issuance of all potential common stock equivalents, which comprise the entire amount of the Company’s outstanding common stock options and warrants, as described in Note 7, and the potential conversion of the First and Second Closing Notes, as described in Note 5, would be anti-dilutive, due to the reporting of a net loss for each of the periods in the accompanying condensed consolidated statements of operations. |
Concentration Risks and Other Risks and Uncertainties | Concentration Risks and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company holds substantially all its cash and cash equivalents on deposit with financial institutions in the U.S. insured by the Federal Deposit Insurance Corporation. At June 30, 2021, the Company had approximately $ 56.7 At June 30, 2021, there were no customers whose accounts receivable balance exceeded 10% of accounts receivable at that date. At December 31, 2020, one customer accounted for 11 Sales Customer Accounts Receivable One customer, a related party as discussed in Note 3, accounted for 21 26 19 26 Prior to granting credit, the Company performs credit evaluations of its customers’ financial condition, and generally does not require collateral from its customers. The Company will provide an allowance for doubtful accounts when collections become doubtful. The allowance for doubtful accounts at June 30, 2021 and December 31, 2020 was $ 0.1 0.06 The Company is subject to risks common to emerging companies in the medical device industry, including, but not limited to: new technological innovations; acceptance and competitiveness of its products; dependence on key personnel; dependence on key suppliers; dependence on third-party collaboration, license and joint development partners; changes in general economic conditions and interest rates; protection of proprietary technology; compliance with changing government regulations; uncertainty of widespread market acceptance of products; access to credit for capital purchases by customers; and product liability claims. Certain components used in manufacturing have relatively few alternative sources of supply and establishing additional or replacement suppliers for such components cannot be accomplished quickly. The inability of any of these suppliers to fulfill the Company’s supply requirements may negatively impact future operating results. |
Adoption of New Accounting Standard | Adoption of New Accounting Standard Effective January 1, 2021, the Company adopted, on a modified retrospective method of transition, the provisions of Accounting Standards Update No. 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) – Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (the “ASU”). The ASU is effective for public companies, other than smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, and for smaller reporting companies, which is the Company’s current classification, for fiscal years beginning after December 31, 2023. However, the ASU permits early adoption, no earlier than for fiscal years beginning after December 31, 2020, and the Company elected such early adoption. The ASU amends prior authoritative literature to reduce the number of accounting models for, among others, convertible debt instruments for which the embedded conversion features of such instruments had previously been required to be separated from the host contract. The Company determined that the conversion feature embedded in the Second Closing Note (see Note 5) was within the scope of the ASU. Accordingly, the discount originally recorded in connection with the issuance of the Second Closing Note and a corresponding amount recorded in additional paid-in capital, each in the amount of approximately $ 3.1 |
Reclassifications | Reclassifications The accompanying consolidated statement of operations for the three and six months ended June 30, 2021 contains: (a) certain items formerly classified as service revenue that that have been reclassified to product revenue; (b) certain items formerly classified as general and administrative expenses, research and development expenses, and sales and marketing expenses that have been reclassified to cost of revenue; and (c) an item formerly classified as interest expense that has been reclassified as other expense. The accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2020 has been conformed to the 2021 presentation. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from External Customers by Products and Services [Table Text Block] | Three Months Ended June 30, (in thousands) 2021 2020 Functional neurosurgery navigation and therapy Disposable products $ 1,861 $ 1,071 Biologics and drug delivery Disposable products 450 407 Services 940 761 Subtotal – biologics and drug delivery revenue 1,390 1,168 Capital equipment and software Systems and software products 52 158 Services 110 81 Subtotal – capital equipment and software revenue 162 239 Total revenue $ 3,413 $ 2,478 Six Months Ended June 30, (in thousands) 2021 2020 Functional neurosurgery navigation and therapy Disposable products $ 3,779 $ 2,812 Biologics and drug delivery Disposable products 1,364 580 Services 1,685 1,616 Subtotal – biologics and drug delivery revenue 3,049 2,196 Capital equipment and software Systems and software products 382 422 Services 233 163 Subtotal – capital equipment and software revenue 615 585 Total revenue $ 7,443 $ 5,593 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory - Schedule of Inventory, Current | Inventory consists of the following as of: Inventory - Schedule of Inventory, Current (in thousands) June 30, December 31, Raw materials and work in process $ 1,764 $ 1,485 Software licenses 245 193 Finished goods 1,566 1,560 Inventory, net, included in current assets 3,575 3,238 Software licenses – non-current 519 589 Total $ 4,094 $ 3,827 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Notes Payable - Schedule of Notes Payable Maturities | Scheduled principal payments as of June 30, 2021 with respect to notes payable are summarized as follows: Notes Payable - Schedule of Notes Payable Maturities Year ending December 31, (in thousands) 2025 $ 17,692 Total scheduled principal payments 17,692 Less: Unamortized financing costs (188 ) Total $ 17,504 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity - Schedule of Share-Based Compensation for Director Fees | The following is information regarding the number of shares issued to directors as payment for director fees in lieu of cash for the three and six months ended June 30, 2021 and 2020: Stockholders’ Equity - Schedule of Share-Based Compensation for Director Fees Three Months Ended June 30, 2021 2020 1,820 9,832 Six Months Ended June 30, 2021 2020 3,829 19,563 |
Stockholders’ Equity - Schedule of Stock Option Activity | Stock option activity under all of the Company’s Plans during the six months ended June 30, 2021 is summarized below: Stockholders’ Equity - Schedule of Stock Option Activity Shares Weighted-average Exercise price per share Intrinsic (1) (in thousands) Outstanding at January 1, 2021 1,806,092 $ 7.12 $ 20,760 Granted 40,030 20.61 Exercised 447,900 2.59 Expired / terminated 18,500 20.46 Outstanding at June 30, 2021 1,379,722 $ 8.19 $ 14,916 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. |
Stockholders’ Equity - Schedule of Common Stock Warrant Activity | Warrants have generally been issued in connection with financing transactions and for terms of up to five years. Common stock warrant activity for the six months ended June 30, 2021 was as follows: Stockholders’ Equity - Schedule of Common Stock Warrant Activity Shares Weighted-average Exercise price per share Intrinsic (1) (in thousands) Outstanding at January 1, 2021 3,082,987 $ 3.82 $ 37,379 Exercised (1,593,971 ) 3.07 Outstanding at June 30, 2021 1,489,016 $ 4.62 $ 21,653 (1) Intrinsic value is calculated as the estimated fair value of the Company’s stock at the end of the related period less the option exercise price of in-the-money options. |
Description of the Business a_2
Description of the Business and Financial Condition (Details Narrative) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Cumulative net loss | $ 125,803 | $ 119,522 | |
Net cash used in operations | 5,849 | $ 4,039 | 7,800 |
Secured convertible notes | 17,504 | 21,280 | |
Proceeds from issuance of Paycheck Protection Program loan | $ 896 | 900 | |
Sale of stock, number of shares issued | 2,127,660 | ||
Proceeds from issuance of stock | $ 46,800 | ||
Security Purchase Agreement | The "2020 Convertible Noteholders" | |||
Secured convertible notes | $ 17,500 | 17,500 | |
Proceeds from debt, net | $ 16,800 | ||
Term of secured notes | 5 years | ||
Security Purchase Agreement | the "2020 Secured Notes" | |||
Secured convertible notes | $ 7,500 | ||
Sale of stock, additional information | The SPA also gave the Company the right, but not the obligation, to request one of the 2020 Convertible Noteholders to purchase an additional $5.0 million in principal amount of a note (the “Second Closing Note”, and, together with the First Closing Note, the “2020 Secured Notes”). |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2020 | Jun. 30, 2021USD ($)Number | Jun. 30, 2020 | Dec. 31, 2020USD ($) | |
Product Information [Line Items] | ||||||
Operating segments | Number | 1 | |||||
Payment terms under contracts with customers | a range of 30-60 days | |||||
Bank balances in excess of insured limits, approximate | $ 56,700 | $ 56,700 | ||||
Allowance for doubtful accounts | $ 100 | 100 | $ 60 | |||
Adoption of ASU 2020-06 | $ 3,107 | $ 3,100 | ||||
Accounts Receivable | Customer | ||||||
Product Information [Line Items] | ||||||
Concentration risk, percentage | 11.00% | |||||
Sales | Customer | ||||||
Product Information [Line Items] | ||||||
Concentration risk, percentage | 21.00% | 26.00% | 19.00% | 26.00% | ||
Minimum [Member] | ||||||
Product Information [Line Items] | ||||||
Term of service agreements (in years) | 1 year | |||||
Maximum [Member] | ||||||
Product Information [Line Items] | ||||||
Term of service agreements (in years) | 3 years |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Revenue Recognition (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 3,413 | $ 2,478 | $ 7,443 | $ 5,593 |
Product - Functional Neurosurgery Navigation and Therapy - Disposable Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 1,861 | 1,071 | 3,779 | 2,812 |
Biologics and Drug Delivery Disposable Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 450 | 407 | 1,364 | 580 |
Biologics and Drug Delivery Services | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 940 | 761 | 1,685 | 1,616 |
Biologics and Drug Delivery | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 1,390 | 1,168 | 3,049 | 2,196 |
Capital Equipment and Software Systems and Software Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 52 | 158 | 382 | 422 |
Capital Equipment and Software Services | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 110 | 81 | 233 | 163 |
Capital Equipment and Software | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 162 | $ 239 | $ 615 | $ 585 |
Revenue Recognition (Details Na
Revenue Recognition (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||||||
Total revenues | $ 3,413 | $ 2,478 | $ 7,443 | $ 5,593 | |||
Unbilled accounts receivable, approximate | 100 | 100 | $ 100 | ||||
Development Services Agreement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront payment commitment | $ 130 | ||||||
Deferred revenue | 20 | 20 | 50 | ||||
Letter of Intent | Investor [Member] | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Total revenues | 700 | 1,500 | 500 | ||||
Deferred revenue | 40 | 40 | 100 | ||||
Reduction of service fees receivable | $ 250 | ||||||
Accounts receivable | 20 | 20 | $ 100 | ||||
Letter of Intent | Investor [Member] | Unbilled Revenues [Member] | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront payment commitment | $ 500 | ||||||
Capital Equipment Related Service Revenue | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Total revenues | $ 90 | 200 | |||||
Remaining Performance Obligations Capital Equipment-Related Service Revenue | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Total revenues | $ 600 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials and work in process | $ 1,764 | $ 1,485 |
Software licenses | 245 | 193 |
Finished goods | 1,566 | 1,560 |
Inventory, net, included in current assets | 3,575 | 3,238 |
Software licenses – non-current | 519 | 589 |
Total | $ 4,094 | $ 3,827 |
Notes Payable - Schedule of Not
Notes Payable - Schedule of Notes Payable Maturities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Debt Disclosure [Abstract] | |
2025 | $ 17,692 |
Total scheduled principal payments | 17,692 |
Less: Unamortized financing costs | (188) |
Total | $ 17,504 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | |||
Secured notes | $ 17,504 | $ 21,280 | |
Conversion of debt | 7,500 | ||
Accrued interest included in the conversion of debt | $ 40 | ||
Shares issued upon conversion of debt | 1,256,143,000 | ||
2010 Junior Secured Notes Payable | |||
Debt Instrument [Line Items] | |||
Repayment of secured debt | $ 2,800 | ||
Payments for accrued interest | $ 900 | ||
Security Purchase Agreement | The "2020 Convertible Noteholders" | |||
Debt Instrument [Line Items] | |||
Secured notes | $ 17,500 | $ 17,500 | |
Terms of debt conversion | At the option of the holders at any time prior to maturity, $10 million in principal amount of the 2020 Secured Convertible Notes are convertible to the Company’s common stock at a conversion price of $6.00, and $7.5 million in principal amount of the 2020 Secured Convertible Notes are convertible at a price of $10.14, subject in both cases to adjustments as set forth in the SPA and the note agreements. | The First Closing Notes may be converted at a price of $6.00 per share, subject to certain adjustments set forth in the SPA, and may not be pre-paid without the consent of the noteholder, provided that the Company must offer to pre-pay such other noteholder on the same terms and conditions. | |
Term of secured notes | 5 years | ||
Interest rate terms | bear interest at a rate equal to the sum of (i) the greater of (a) the three (3)-month London Interbank Offered Rate (“LIBOR”) and (b) two percent (2%), plus (ii) a margin of 2% on the outstanding balance of the First Closing Notes, payable quarterly on the first business day of each calendar quarter. | ||
Security Purchase Agreement | First Closing Notes | |||
Debt Instrument [Line Items] | |||
Secured notes | $ 200 | $ 400 | |
Conversion of debt | 7,500 | ||
Accrued interest included in the conversion of debt | $ 40 | ||
Shares issued upon conversion of debt | 1,256,143 | ||
Commitment fee | 200 | ||
Reversal of commitment fee | 200 | ||
Security Purchase Agreement | Second Closing Note | |||
Debt Instrument [Line Items] | |||
Secured notes | $ 3,100 | ||
Closing price per share | $ 14.34 | ||
Security Purchase Agreement Amended | The "2020 Convertible Noteholders" | |||
Debt Instrument [Line Items] | |||
Secured convertible notes, terms and conditions | the Company and the 2020 Convertible Noteholders entered into the Amendment to the SPA, the terms of which, among other provisions, provided for: (a) an increase in the principal amount of the Second Closing Note to $7.5 million; (b) a revision of the interest rate to be borne by the Second Closing Note to consist of: (i) cash interest of 2% per annum, payable quarterly; and (ii) payment-in-kind interest of 5% per annum, accruable quarterly as an addition to the unpaid principal balance of the Second Closing Note; and (c) an increase in the conversion price of the Second Closing Notes to $10.14 per share, subject to certain adjustments set forth in the SPA |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Lessee, Lease, Description [Line Items] | ||||
Lease cost (included in general and administrative expense) | $ 100 | $ 30 | $ 300 | $ 60 |
Office Lease - Irvine, California | ||||
Lessee, Lease, Description [Line Items] | ||||
Commenced date | Oct. 1, 2018 | |||
Lease expiration date | September 2023 | |||
Lease term | 5 years | 5 years | ||
Lease renewal term | 5 years | 5 years | ||
Office Lease - Solana Beach, California | ||||
Lessee, Lease, Description [Line Items] | ||||
Commenced date | Dec. 15, 2020 | |||
Lease term | 5 years | 5 years | ||
Lease renewal term | 5 years | 5 years | ||
Lease expiration date | Dec. 31, 2026 |
Stockholders_ Equity - Schedule
Stockholders’ Equity - Schedule of Share-Based Compensation for Director Fees (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Equity [Abstract] | ||||
Number of shares issued as payment for directors fees in lieu of cash | 1,820 | 9,832 | 3,829 | 19,563 |
Stockholders_ Equity - Schedu_2
Stockholders’ Equity - Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Equity [Abstract] | |
Outstanding at January 1, 2021 | shares | 1,806,092 |
Weighted-average exercise price per share, outstanding | $ / shares | $ 7.12 |
Intrinsic value, outstanding | $ | $ 20,760 |
Granted | shares | 40,030 |
Weighted-average exercise price per share, granted | $ / shares | $ 20.61 |
Exercised | shares | 447,900 |
Weighted-average exercise price per share, exercised | $ / shares | $ 2.59 |
Expired / terminated | shares | 18,500 |
Weighted-average exercise price per share, Expired / terminated | $ / shares | $ 20.46 |
Outstanding at June 30, 2021 | shares | 1,379,722 |
Weighted-average exercise price per share, outstanding | $ / shares | $ 8.19 |
Intrinsic value, outstanding | $ | $ 14,916 |
Stockholders_ Equity - Schedu_3
Stockholders’ Equity - Schedule of Common Stock Warrant Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Equity [Abstract] | |
Outstanding at January 1, 2021 | shares | 3,082,987 |
Weighted-average exercise price per share, outstanding | $ / shares | $ 3.82 |
Intrinsic value, outstanding | $ | $ 37,379 |
Exercised | shares | (1,593,971) |
Weighted-average exercise price per share, exercised | $ / shares | $ 3.07 |
Outstanding at June 30, 2021 | shares | 1,489,016 |
Outstanding at June 30, 2021 | $ / shares | $ 4.62 |
Intrinsic value, outstanding | $ | $ 21,653 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2020 | Jun. 02, 2020 | |
Subsidiary, Sale of Stock [Line Items] | |||
Sale of stock, number of shares issued | 2,127,660 | ||
Proceeds from issuance of stock | $ 46,800 | ||
Number of awards granted | 40,030 | ||
Number of awards outstanding | 1,379,722 | 1,806,092 | |
Unrecognized compensation expense | $ 2,400 | ||
Compensation expense, period for recognition | 1 year 9 months 18 days | ||
Amended and Restated 2013 Incentive Compensation Plan | |||
Subsidiary, Sale of Stock [Line Items] | |||
Shares available for issuance | 1,339,576 | 1,000,000 | |
Common stock reserved for issuance | 2,956,250 | ||
Number of awards granted | 440,995 | ||
Number of awards outstanding | 1,175,679 | ||
Employee Stock Purchase Plan | |||
Subsidiary, Sale of Stock [Line Items] | |||
Shares available for issuance | 400,000 | ||
Public Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Sale of stock, number of shares issued | 2,127,660 | ||
Common stock initial offered at public offering | 1,850,140 | ||
Public offering price | $ 23.50 | ||
Shares sold pursuant to exercise of underwriters option | 277,520 | ||
Price per share for underwriters option to purchase | $ 22.09 | ||
Proceeds from issuance of stock | $ 46,800 |