Vicarious Surgical Inc. - Quarter Report: 2023 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2023
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-39384
VICARIOUS SURGICAL INC.
(Exact name of registrant as specified in its charter)
Delaware | 87-2678169 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
78 Fourth Avenue Waltham, Massachusetts | 02451 | |
(Address of principal executive offices) | (Zip Code) |
617-868-1700
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | ||
Class A common stock, $0.0001 par value per share | RBOT | The New York Stock Exchange | ||
Warrants to purchase one share of Class A common stock, each at an exercise price of $11.50 per share | RBOT WS | The New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Non-accelerated filer ☒ | Smaller reporting company ☒ |
Emerging growth company ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of July 13, 2023, the registrant had 107,684,617 shares of Class A common stock outstanding and 19,619,760 shares of Class B common stock outstanding.
TABLE OF CONTENTS
In this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” the “Company” and “Vicarious Surgical” mean Vicarious Surgical Inc. (formerly D8 Holdings Corp.) and our subsidiaries. On September 17, 2021, D8 Holdings Corp., a Delaware corporation that was previously a Cayman Islands exempted company (“D8” and after the Business Combination described herein, the “Company”) that migrated to and domesticated (the “Domestication”), consummated the previously announced business combination (the “Business Combination”) pursuant to the terms of the Agreement and Plan of Merger, dated as of April 15, 2021 (the “Business Combination Agreement”), by and among D8, Snowball Merger Sub, Inc., a Delaware corporation (“Merger Sub”), and Vicarious Surgical Inc., a Delaware corporation (“Legacy Vicarious Surgical”). Immediately upon the consummation of the Business Combination, the Domestication and the other transactions contemplated by the Business Combination Agreement (collectively, the “Transactions”), Merger Sub merged with and into Legacy Vicarious Surgical, with Legacy Vicarious Surgical surviving the Business Combination as a wholly-owned subsidiary of D8. In connection with the Transactions, D8 changed its name to “Vicarious Surgical Inc.” and Legacy Vicarious Surgical changed its name to “Vicarious Surgical US Inc.”
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that relate to future events, our future operations or financial performance, or our plans, strategies and prospects. These statements are based on the beliefs and assumptions of our management team. Although we believe that our plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, we cannot assure that we will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events or performance, are forward-looking statements. These statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these identifying words. The forward-looking statements are based on projections prepared by, and are the responsibility of, our management team. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
● | the ability to recognize the benefits of the Business Combination, which may be affected by, among other things, competition and our ability to grow and manage growth profitably and retain our key employees; |
● | the ability to maintain the listing of our Class A common stock on the New York Stock Exchange (“NYSE”); |
● | the success, cost and timing of our product and service development activities; |
● | the approval, commercialization and adoption of our initial product candidates and the success of our single-port surgical robot, called the Vicarious Surgical System, and any of our future product candidates and service offerings; |
● | the potential attributes and benefits of the Vicarious Surgical System and any of our other product and service offerings once commercialized; |
● | our ability to obtain and maintain regulatory authorization for the Vicarious Surgical System and our product and service offerings on the timeline we expect, and without unexpected restrictions and limitations of any authorized product or service offering; |
● | changes in U.S. and foreign laws; |
● | our ability to identify, in-license or acquire additional technology; |
● | our ability to maintain our existing license agreements and manufacturing arrangements and scale manufacturing of the Vicarious Surgical System and any future product candidates to commercial quantities; |
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● | our ability to compete with other companies currently marketing or engaged in the development of products and services for use in ventral hernia repair procedures and additional surgical applications, as well as with the use of open surgeries; |
● | the size and growth potential of the markets for the Vicarious Surgical System and any of our future product and service offerings, and the ability of each to serve those markets once commercialized, either alone or in partnership with others; |
● | our estimates regarding expenses, future revenue, capital requirements, cash runway and needs for additional financing; |
● | our ability to raise financing in the future; |
● | our financial performance; |
● | our intellectual property rights and our ability to protect or enforce these rights, and the impact on our business, results and financial condition if we are unsuccessful in doing so; and |
● | our ability to address economic downturns and political and market conditions beyond our control and their potential to adversely affect our business, financial condition and results of operations, including, but not limited to, increasing our expenses and cost of capital and adverse impacting our supply chain. |
These forward-looking statements are based on information available as of the date of this report, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Important factors could cause actual results, performance or achievements to differ materially from those indicated or implied by forward-looking statements such as those described under the caption “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K, elsewhere herein and in other filings that we make from time to time with the Securities and Exchange Commission. The risks described in such filings are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. We undertake no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
VICARIOUS SURGICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share and per share data)
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 32,807 | $ | 116,208 | ||||
Short-term investments | 49,976 | $ | ||||||
Prepaid expenses and other current assets | 2,498 | 4,196 | ||||||
Total current assets | 85,281 | 120,404 | ||||||
Restricted cash | 936 | 936 | ||||||
Property and equipment, net | 6,254 | 6,586 | ||||||
Right-of-use assets | 11,875 | 12,273 | ||||||
Other long-term assets | 180 | 92 | ||||||
Total assets | $ | 104,526 | $ | 140,291 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,585 | $ | 1,731 | ||||
Accrued expenses | 4,937 | 5,808 | ||||||
Lease liabilities, current portion | 967 | 838 | ||||||
Current portion of equipment loans | 16 | |||||||
Total current liabilities | 7,489 | 8,393 | ||||||
Lease liabilities, net of current portion | 14,329 | 14,832 | ||||||
Warrant liabilities | 7,019 | 6,021 | ||||||
Total liabilities | 28,837 | 29,246 | ||||||
Commitments and Contingencies (Note 8) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; | shares issued or outstanding at June 30, 2023 and December 31, 2022||||||||
Class A Common stock, $0.0001 par value; 300,000,000 shares authorized at June 30, 2023 and December 31, 2022; 107,647,657 and 106,251,429 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 11 | 11 | ||||||
Class B Common stock, $0.0001 par value; 22,000,000 shares authorized at June 30, 2023 and December 31, 2022; 19,619,760 and 19,627,576 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 2 | 2 | ||||||
Additional paid-in capital | 179,703 | 172,673 | ||||||
Accumulated other comprehensive loss | (130 | ) | ||||||
Accumulated deficit | (103,897 | ) | (61,641 | ) | ||||
Total stockholders’ equity | 75,689 | 111,045 | ||||||
Total liabilities and stockholders’ equity | $ | 104,526 | $ | 140,291 |
See accompanying notes to these condensed consolidated financial statements.
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VICARIOUS SURGICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share data)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 12,714 | $ | 10,055 | $ | 26,070 | $ | 19,903 | ||||||||
Sales and marketing | 1,666 | 1,311 | 3,626 | 2,713 | ||||||||||||
General and administrative | 7,078 | 7,760 | 14,077 | 14,690 | ||||||||||||
Total operating expenses | 21,458 | 19,126 | 43,773 | 37,306 | ||||||||||||
Loss from operations | (21,458 | ) | (19,126 | ) | (43,773 | ) | (37,306 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Change in fair value of warrant liabilities | 5,081 | 17,601 | (998 | ) | 78,329 | |||||||||||
Interest and other income | 1,044 | 101 | 2,517 | 109 | ||||||||||||
Interest expense | (1 | ) | (29 | ) | (2 | ) | (58 | ) | ||||||||
Income/(loss) before income taxes | (15,334 | ) | (1,453 | ) | (42,256 | ) | 41,074 | |||||||||
Provision for income taxes | ||||||||||||||||
Net income/(loss) | $ | (15,334 | ) | $ | (1,453 | ) | $ | (42,256 | ) | $ | 41,074 | |||||
Net income/(loss) per share of Class A and Class B common stock, basic | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.33 | ) | $ | 0.34 | |||||
Net income/(loss) per share of Class A and Class B common stock, diluted | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.33 | ) | $ | 0.32 | |||||
Other comprehensive income/(loss): | ||||||||||||||||
Net unrealized income/(loss) on investments | (195 | ) | (130 | ) | ||||||||||||
Other comprehensive income/(loss) | (195 | ) | (130 | ) | ||||||||||||
Comprehensive net income/(loss) | $ | (15,529 | ) | $ | (1,453 | ) | $ | (42,386 | ) | $ | 41,074 |
See accompanying notes to these condensed consolidated financial statements.
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VICARIOUS SURGICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMMON STOCK AND STOCKHOLDERS’ EQUITY/(DEFICIT)
(Unaudited)
(in thousands, except share data)
Three Months Ended June 30, 2023 | ||||||||||||||||||||||||
Class A & B | Additional | Accumulated Other | Total | |||||||||||||||||||||
Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balance, March 31, 2023 | 126,478,363 | $ | 13 | $ | 176,213 | $ | (88,563 | ) | $ | 65 | $ | 87,728 | ||||||||||||
Exercise of common stock options | 509,398 | 166 | 166 | |||||||||||||||||||||
Vesting of restricted stock | 279,656 | |||||||||||||||||||||||
Stock-based compensation | — | 3,324 | 3,324 | |||||||||||||||||||||
Net loss | — | (15,334 | ) | (15,334 | ) | |||||||||||||||||||
Other comprehensive income/(loss) | — | (195 | ) | (195 | ) | |||||||||||||||||||
Balance, June 30, 2023 | 127,267,417 | $ | 13 | $ | 179,703 | $ | (103,897 | ) | $ | (130 | ) | $ | 75,689 |
Six Months Ended June 30, 2023 | ||||||||||||||||||||||||
Class A & B | Additional | Accumulated Other | Total | |||||||||||||||||||||
Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balance, January 1, 2023 | 125,879,005 | $ | 13 | $ | 172,674 | $ | (61,641 | ) | $ | $ | 111,046 | |||||||||||||
Exercise of common stock options | 833,805 | 251 | 251 | |||||||||||||||||||||
Vesting of restricted stock | 554,607 | |||||||||||||||||||||||
Stock-based compensation | — | 6,578 | 6,578 | |||||||||||||||||||||
Proceeds from short swing rule | — | 200 | 200 | |||||||||||||||||||||
Net loss | — | (42,256 | ) | (42,256 | ) | |||||||||||||||||||
Other comprehensive income/(loss) | — | (130 | ) | (130 | ) | |||||||||||||||||||
Balance, June 30, 2023 | 127,267,417 | $ | 13 | $ | 179,703 | $ | (103,897 | ) | $ | (130 | ) | $ | 75,689 |
Three Months Ended June 30, 2022 | ||||||||||||||||||||||||
Class A & B | Additional | Accumulated Other | Total | |||||||||||||||||||||
Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balance, March 31, 2022 | 121,168,655 | $ | 12 | $ | 152,490 | $ | (24,271 | ) | $ | $ | 128,231 | |||||||||||||
Exercise of common stock options | 359,331 | 221 | 221 | |||||||||||||||||||||
Vesting of restricted stock | 103,749 | |||||||||||||||||||||||
Stock-based compensation | — | 2,780 | 2,780 | |||||||||||||||||||||
Net loss | — | (1,453 | ) | (1,453 | ) | |||||||||||||||||||
Balance, June 30, 2022 | 121,631,735 | $ | 12 | $ | 155,491 | $ | (25,724 | ) | $ | $ | 129,779 |
Six Months Ended June 30, 2022 | ||||||||||||||||||||||||
Class A & B | Additional | Accumulated Other | Total | |||||||||||||||||||||
Common Stock | Paid-In | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balance, January 1, 2022 | 119,769,067 | $ | 12 | $ | 149,877 | $ | (66,798 | ) | $ | $ 83,091 | ||||||||||||||
Exercise of common stock options | 1,702,183 | 557 | 557 | |||||||||||||||||||||
Exercise of public warrants | 20 | |||||||||||||||||||||||
Vesting of restricted stock | 160,465 | |||||||||||||||||||||||
Stock-based compensation | — | 5,057 | 5,057 | |||||||||||||||||||||
Net income | — | 41,074 | 41,074 | |||||||||||||||||||||
Balance, June 30, 2022 | 121,631,735 | $ | 12 | $ | 155,491 | $ | (25,724 | ) | $ | $ | 129,779 |
See accompanying notes to these condensed consolidated financial statements.
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VICARIOUS SURGICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
Six Months Ended June 30, | ||||||||
2023 | 2022 | |||||||
Cash flows from operating activities: | ||||||||
Net income/(loss) | $ | (42,256 | ) | $ | 41,074 | |||
Adjustments to reconcile net income/(loss) to net cash used in operating activities: | ||||||||
Depreciation | 882 | 371 | ||||||
Stock-based compensation | 6,578 | 5,057 | ||||||
Amortization of capitalized debt issuance costs | 17 | |||||||
Non-cash lease expense | 397 | 435 | ||||||
Change in fair value of warrant liabilities | 998 | (78,329 | ) | |||||
Change in accrued interest and net accretion of discounts on short-term investments | (434 | ) | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | 1,698 | 2,548 | ||||||
Accounts payable | (181 | ) | (333 | ) | ||||
Accrued expenses | (872 | ) | 167 | |||||
Lease liabilities | (374 | ) | 27 | |||||
Other noncurrent assets | (88 | ) | ||||||
Net cash used in operating activities | (33,652 | ) | (28,966 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (514 | ) | (3,578 | ) | ||||
Purchases of available-for-sale investments | (62,205 | ) | ||||||
Proceeds from sales and maturities of available-for-sale investments | 12,535 | |||||||
Net cash used in investing activities | (50,184 | ) | (3,578 | ) | ||||
Cash flows from financing activities: | ||||||||
Repayment of equipment loans | (16 | ) | (24 | ) | ||||
Repayment of term loan | (300 | ) | ||||||
Proceeds from short swing rule | 200 | |||||||
Proceeds from exercise of stock options | 251 | 557 | ||||||
Net cash provided by financing activities | 435 | 233 | ||||||
Change in cash, cash equivalents and restricted cash | (83,401 | ) | (32,311 | ) | ||||
Cash, cash equivalents and restricted cash, beginning of period | 117,144 | 174,562 | ||||||
Cash, cash equivalents and restricted cash, end of period | $ | 33,743 | $ | 142,251 | ||||
Reconciliation of restricted cash: | ||||||||
Cash and cash equivalents | 32,807 | 141,315 | ||||||
Restricted cash | 936 | 936 | ||||||
$ | 33,743 | $ | 142,251 | |||||
Supplemental cash flow information: | ||||||||
Interest paid | $ | 1 | $ | 23 | ||||
Non-cash investing and financing activities: | ||||||||
Accruals for property, plant and equipment purchased during the period | $ | 36 | $ | 159 |
See accompanying notes to these condensed consolidated financial statements.
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VICARIOUS SURGICAL INC.
NOTES TO Condensed consolidated FINANCIAL STATEMENTS
(in thousands, except for share and per share data)
1. | NATURE OF BUSINESS AND BASIS OF PRESENTATION |
Nature of Business
Vicarious Surgical Inc. (including its subsidiaries, “Vicarious” or the “Company”) was originally incorporated in the Cayman Islands as a special purpose acquisition company under the name D8 Holdings Corp. (“D8”) for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination involving D8 and one or more businesses. On September 17, 2021, the Company consummated the transaction (the “Closing”) contemplated by the Agreement and Plan of Merger, dated as of April 15, 2021 (the “Business Combination Agreement”), by and among D8, Snowball Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of D8 (“Merger Sub”), and Vicarious Surgical Inc., a Delaware corporation incorporated in the State of Delaware on May 1, 2014 (“Legacy Vicarious Surgical”). The Company is headquartered in Waltham, Massachusetts.
Pursuant to the terms of the Business Combination Agreement, a business combination between D8 was effected through the merger of Merger Sub with and into Legacy Vicarious Surgical, with Legacy Vicarious Surgical surviving as a wholly owned subsidiary of D8 (the “Merger,” and collectively with the other transactions described in the Business Combination Agreement, the “Business Combination”). Effective as of the Closing, D8 changed its name to Vicarious Surgical Inc. and Legacy Vicarious Surgical changed its name to Vicarious Surgical US Inc.
The Company is currently developing its differentiated surgical robotic system using proprietary de-coupled actuators to transport surgeons inside the patient to perform minimally invasive surgical procedures.
The Company has not yet generated any revenue from operations. Management believes that the Company’s current cash, cash equivalents and short-term investments balance of $82,783 will be sufficient to support our operations beyond the next twelve months from the date of issuance of these financial statements. However, we do not anticipate that the current cash, cash equivalents and marketable securities as of June 30, 2023 will be sufficient for us to fund our development through commercialization, and we will need to raise additional capital to complete the development and commercialization of our product. We may satisfy our future cash needs through the sale of equity securities, debt financings, corporate collaborations or other agreements, working capital lines of credit, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources.
The accompanying condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“US GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP.
Unless otherwise indicated or the context otherwise requires, references in this Quarterly Report on Form 10-Q to the “Company” and “Vicarious Surgical” refer to the consolidated operations of Vicarious Surgical Inc. References to “D8” refer to the Company prior to the consummation of the Business Combination and references to “Legacy Vicarious Surgical” refer to Vicarious Surgical Inc. prior to the consummation of the Business Combination.
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Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared in conformity with accounting principles generally accepted in the United States of America (“US GAAP”) and pursuant to regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the condensed consolidated financial statements prepared in accordance with US GAAP may have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes for the years ended December 31, 2022 and 2021. The condensed consolidated balance sheet as of December 31, 2022, included herein, was derived from the audited consolidated financial statements of the Company.
The condensed consolidated financial statements, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, necessary to present fairly our financial position as of June 30, 2023, our results of operations, and stockholders’ equity for the three and six-month periods ended June 30, 2023 and 2022, and our cash flows for the six-month periods ended June 30, 2023 and 2022. The operating results for the three and six-month periods ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any interim period or for any other future year.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
The accompanying condensed consolidated financial statements reflect the application of certain significant accounting policies as described in this note and elsewhere in the accompanying condensed consolidated financial statements and notes.
Use of Estimates
The preparation of financial statements in conformity with US GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods presented. Estimates are used for, but are not limited to, the Company’s ability to continue as a going concern, depreciation of property and equipment, fair value of financial instruments, and contingencies. Actual results may differ from those estimates.
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Fair Value of Financial Instruments
US GAAP requires disclosure of fair value information about financial instruments, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. The framework provides a fair value hierarchy that prioritizes the inputs for the valuation techniques. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements) and minimizes the use of unobservable inputs. The most observable inputs are used, when available. The three levels of the fair value hierarchy are described as follows:
Level 1—Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access.
Level 2—Inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived from, or corroborated by, observable market data by correlation or other means.
Level 3—Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
The fair value of the Company’s publicly traded warrants (the “Public Warrants”) was determined from their trading value on public markets. The fair value of the Company’s warrants sold in a private placement (the “Private Placement Warrants”) was calculated using the Black-Scholes option pricing model since these instruments do not have the early redemption feature.
Cash and Cash Equivalents
Cash and cash equivalents consist of checking accounts, money market funds, U.S. treasury securities and U.S. government agency securities. The Company considers all highly liquid investments with an original maturity of 90 days or less at the date of purchase to be cash equivalents.
Restricted Cash
The Company has an agreement to maintain a cash balance of $936 at June 30, 2023 and December 31, 2022 as collateral for a letter of credit related to the Company’s lease. The balance is classified as long-term on the Company’s balance sheets as the lease period ends in March 2032.
Short-Term Investments
All of the Company’s investments, which consist of U.S. treasury securities and U.S. government agency securities, are classified as available-for-sale and are carried at fair value. There were unrealized losses of $195 and $130 for the three and six-month periods ended June 30, 2023, respectively. There were no unrealized gains or losses for the year ended December 31, 2022.
Concentrations of Credit Risk and Off-Balance-Sheet Risk
The Company has no significant off-balance-sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist mainly of cash and cash equivalents. The Company maintains its cash and cash equivalents principally with accredited financial institutions of high-credit standing. Periodically, there may be times when the deposits exceed the FDIC insurance limits.
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Warrant Liabilities
The Company does not use derivative instruments to hedge its exposures to cash flow, market or foreign currency risks. Management evaluates all of the Company’s financial instruments, including issued warrants to purchase its Class A common stock, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and ASC 815-15. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period.
As part of the Business Combination, the Company assumed 17,249,991 publicly traded warrants (the “Public Warrants”) that are exercisable to purchase shares of Class A common stock to investors as well as 10,400,000 Private Placement Warrants. All of the Company’s outstanding warrants are recognized as derivative liabilities in accordance with ASC 815-40. Accordingly, the Company recognizes the warrants as liabilities at fair value and adjusts the warrant liability to fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in the statement of operations. The fair value of Public Warrants was determined from their trading value on public markets. The fair value of Private Placement Warrants was calculated using the Black-Scholes option pricing model.
Property and Equipment
Property and equipment are recorded at cost. Expenditures for repairs and maintenance are expensed as incurred. When assets are retired or disposed of, the assets and related accumulated depreciation are eliminated from the accounts, and any resulting gain or loss is included in the determination of net loss. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets.
Impairment of Long-Lived Assets
The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company does not believe that any events have occurred through June 30, 2023, that would indicate its long-lived assets are impaired.
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Guarantees and Indemnifications
As permitted under Delaware law, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. Through June 30, 2023, the Company had not experienced any losses related to these indemnification obligations, and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related liabilities have been established.
Research and Development
Research and development costs are expensed in the period incurred. Research and development costs include payroll and personnel expenses, consulting costs, software and web services, legal, raw materials and allocated overhead such as depreciation and amortization, rent and utilities. Advance payments for goods and services to be used in future research and development activities are recorded as prepaid expenses and are expensed over the service period as the services are provided or when the goods are consumed.
Stock-Based Compensation
The Company accounts for all stock-based compensation, including stock options, restricted stock units (“RSUs”), warrants and other forms of equity issued as compensation for services, at fair value and recognizes stock-based compensation expense for those equity awards, net of actual forfeitures, over the requisite service period, which is generally the vesting period of the respective award.
The fair value of the Company’s stock options on the date of grant is determined by a Black-Scholes option pricing model utilizing key assumptions such as stock price, expected volatility and expected term. The Company’s estimates of these assumptions are primarily based on the fair value of the Company’s stock, historical data, peer company data and judgment regarding future trends. Prior to becoming a publicly traded company, the fair value of the Company’s common stock was determined by the Board of Directors at each award grant date based upon a variety of factors, including the results obtained from an independent third-party valuation, the Company’s financial position and historical financial performance, the status of technological developments within the Company’s proposed product candidates, the illiquid nature of the common stock, arm’s length sales of the Company’s capital stock, including convertible preferred stock, the effect of the rights and preferences of the preferred stockholders, and the prospects of a liquidity event, among others, as the Company’s common stock was not actively traded. Since becoming a publicly traded company, the Company uses its publicly traded stock price as the fair value of its common stock.
The fair market value of RSUs is based on the closing stock price on the grant date.
Income Taxes
The Company accounts for income taxes under the asset and liability method pursuant to ASC 740, Accounting for Income Taxes, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that management believes that these assets are more likely than not to be realized in the future. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations.
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The Company provides reserves for potential payments of taxes to various tax authorities related to uncertain tax positions. Amounts recognized are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is “more likely than not” to be sustained on audit. The amount recognized is equal to the largest amount that is more than 50% likely to be sustained. Interest and penalties associated with uncertain tax positions are recorded as a component of income tax expense.
Net Income/(Loss) Per Share
Basic net income/(loss) per share attributable to common stockholders is computed by dividing the net income/(loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net income/(loss) per share attributable to common stockholders is computed by dividing the net income/(loss) attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common stock. For the purpose of this calculation, outstanding stock options, restricted stock units and stock warrants are considered potential dilutive common stock and are excluded from the computation of net loss per share as their effect is anti-dilutive.
Accordingly, in periods in which the Company reports a net loss, such losses are not allocated to such participating securities. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to be outstanding when their effect is anti-dilutive.
Segments
Operating segments are identified as components of an enterprise about which separate discrete financial information is made available for evaluation by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The CODM is the Company’s chief executive officer. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular concentration is focused on the development of its differentiated, human-like surgical robotic system.
Emerging Growth Company Status
The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Pursuant to the JOBS Act, an emerging growth company is provided the option to adopt new or revised accounting standards that may be issued by Financial Accounting Standards Board (“FASB”) or the SEC either (i) within the same periods as those otherwise applicable to non-emerging growth companies or (ii) within the same time periods as private companies. We intend to take advantage of the exemption for complying with new or revised accounting standards within the same time periods as private companies so long as we qualify as an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies.
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3. | SHORT-TERM INVESTMENTS |
Short-term investments consist of U.S. treasury and U.S. government agency securities and are classified as available-for-sale.
Available-for-sale investments are reported at fair value, with unrealized gains or losses reported in accumulated other comprehensive income. The fair values of our available-for-sale cash and cash equivalents securities are Level 1 measurements, based on quoted prices from active markets for identical assets. The fair values of our available-for-sale short-term investments securities are Level 2 measurements, based on quoted prices from inactive markets for identical assets.
The amortized cost, gross unrealized holding gains, gross unrealized holding losses and fair value of our marketable securities by type of security as of June 30, 2023 was as follows:
June 30, 2023 | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||
Assets: | ||||||||||||||||
U.S. treasury and U.S. government securities | 50,106 | (130 | ) | 49,976 | ||||||||||||
Total assets | $ | 50,106 | $ | $ | (130 | ) | $ | 49,976 |
The aggregate fair value of available-for-sale debt securities in an unrealized loss position as of June 30, 2023 was $49,976. We did not have any investments in a continuous unrealized loss position for more than twelve months as of June 30, 2023. As of June 30, 2023, we believe that the cost basis of our available-for-sale debt securities is recoverable. No allowance for credit losses was recorded as of June 30, 2023.
4. | PROPERTY AND EQUIPMENT, NET |
Property and equipment, net consist of the following:
Estimated | June 30, | December 31, | ||||||||||
Useful Lives | 2023 | 2022 | ||||||||||
Machinery and equipment | 3 to 5 years | $ | 2,173 | $ | 1,906 | |||||||
Furniture and fixed assets | 3 to 7 years | 1,165 | 1,059 | |||||||||
Computer hardware and software | 3 years | 1,204 | 1,155 | |||||||||
Leasehold improvements | Lesser of lease term or asset life | 4,288 | 4,161 | |||||||||
Total property and equipment | 8,830 | 8,281 | ||||||||||
Less accumulated depreciation | (2,576 | ) | (1,695 | ) | ||||||||
Property and equipment, net | $ | 6,254 | $ | 6,586 |
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In connection with the Waltham lease, the Company received $1,200 in August 2022 related to leasehold improvements funded by its landlord. These leasehold improvements are being depreciated over the shorter of the lease term or each asset’s life. The $1,200 was included in leasehold improvements.
In connection with the Waltham lease, the Company received $840 in May 2021 related to leasehold improvements funded by its landlord. These leasehold improvements are being depreciated over the shorter of the lease term or each asset’s life. The $840 paid to vendors by the landlord was included in leasehold improvements.
Depreciation expense for the three and six-month periods ended June 30, 2023 was $440 and $882, respectively. Depreciation expense for the three and six-month periods ended June 30, 2022 was $186 and $371, respectively.
5. | FAIR VALUE MEASUREMENTS |
The following fair value hierarchy table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the fair value hierarchy of the inputs the Company utilized to determine such fair value:
June 30, 2023 | ||||||||||||||||
Quoted Prices | ||||||||||||||||
in Active Markets for Identical Items | Significant Other Observable Inputs | Significant Unobservable Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | 24,859 | $ | $ | $ | 24,859 | ||||||||||
U.S. treasury securities | 49,976 | 49,976 | ||||||||||||||
Total assets | $ | 24,859 | $ | 49,976 | $ | $ | 74,835 | |||||||||
Liabilities: | ||||||||||||||||
Warrant liabilities - public warrants | $ | 3,795 | $ | $ | $ | 3,795 | ||||||||||
Warrant liabilities - private warrants | 3,224 | 3,224 | ||||||||||||||
Total liabilities | $ | 3,795 | $ | $ | 3,224 | $ | 7,019 |
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December 31, 2022 | ||||||||||||||||
Quoted Prices in Active Markets for Identical Items | Significant Other Observable Inputs | Significant Unobservable Inputs | ||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | 114,409 | $ | $ | $ | 114,409 | ||||||||||
Total assets | $ | 114,409 | $ | $ | $ | 114,409 | ||||||||||
Liabilities: | ||||||||||||||||
Warrant liabilities - public warrants | $ | 2,589 | $ | $ | $ | 2,589 | ||||||||||
Warrant liabilities - private warrants | 3,432 | 3,432 | ||||||||||||||
Total liabilities | $ | 2,589 | $ | $ | 3,432 | $ | 6,021 |
Money market funds are classified as cash and cash equivalents. U.S. treasury securities are classified as cash equivalents when the date from initial purchase to maturity is less than 90 days. The remaining investments are classified as short-term investments.
The carrying values of prepaid expenses, right of use assets, accounts payable, and accrued expenses approximate their fair values due to the short-term nature of the instruments. The fair values of our short-term investments are Level 2 measurements as the US government securities are not the most recent offerings and are therefore not traded in an active market.
The fair value of the Public Warrants was determined from their trading value on public markets. The fair value of the Private Placement Warrants was calculated using the Black-Scholes option pricing model. The significant assumptions used in the model were the Company’s stock price, exercise price, expected term, volatility, interest rate, and dividend yield.
For the three months ended June 30, 2023, the Company recognized a gain to the statement of operations resulting from a decrease in the fair value of liabilities of $5,081 presented as a change in fair value of warrant liabilities on the accompanying statement of operations. For the six months ended June 30, 2023, the Company recognized a loss to the statement of operations resulting from an increase in the fair value of liabilities of $998 presented as a change in fair value of warrant liabilities on the accompanying statement of operations.
The Company estimates the volatility of its warrants based on implied volatility from the Company’s Public Warrants and from historical volatility of select peer companies’ common stock that matches the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates remaining at zero.
The following table provides quantitative information regarding the inputs used in determining the fair value of the Company’s Level 3 liabilities:
Private Placement Warrants | As of June 30, 2023 | As of December 31, 2022 | ||||||
Volatility | 81.0 | % | 72.0 | % | ||||
Stock price | $ | 1.83 | $ | 2.02 | ||||
Expected life of options | 3.2 years | 3.7 years | ||||||
Risk-free rate | 4.4 | % | 4.1 | % | ||||
Dividend yield | 0.00 | % | 0.00 | % |
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The following table shows the change in number and value of the warrants since December 31, 2022:
Public | Private | Total | ||||||||||||||||||||||
Shares | Value | Shares | Value | Shares | Value | |||||||||||||||||||
December 31, 2022 | 17,248,601 | $ | 2,589 | 10,400,000 | $ | 3,432 | 27,648,601 | $ | 6,021 | |||||||||||||||
Change in value | $ | 4,311 | $ | 1,768 | $ | 6,079 | ||||||||||||||||||
March 31, 2023 | 17,248,601 | $ | 6,900 | 10,400,000 | $ | 5,200 | 27,648,601 | $ | 12,100 | |||||||||||||||
Change in value | $ | (3,105 | ) | $ | (1,976 | ) | $ | (5,081 | ) | |||||||||||||||
June 30, 2023 | 17,248,601 | $ | 3,795 | 10,400,000 | $ | 3,224 | 27,648,601 | $ | 7,019 |
6. | ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
The following table summarizes the Company’s components of accrued expenses and other current liabilities:
As of | ||||||||
June 30, 2023 | December 31, 2022 | |||||||
Compensation and benefits related | $ | 4,117 | $ | 5,240 | ||||
Professional services and other | 820 | 568 | ||||||
Accrued expenses | $ | 4,937 | $ | 5,808 |
7. | DEBT |
Term Loan
In October 2020, the Company entered into a term loan agreement that provided the Company with the ability to borrow up to $3,500 with any amounts borrowed becoming due on April 1, 2024. The loan consisted of up to two tranches; a $1,500 tranche which became available to the Company upon the close of the loan agreement in October 2020 and was available to the Company to draw through March 31, 2021 and a second tranche of $2,000 which became available to the Company through September 30, 2021, upon the Company’s successful achievement of a milestone related to the development of the Company’s surgical robot. Although the milestone was achieved, the Company chose not to draw down the $2,000 tranche.
The term loan was interest-only through September 30, 2021, at which time the Company made the first of 30 equal monthly payments of principal plus interest. The term loan bears interest at a floating rate equal to the Prime Rate, but not less than a minimum rate of 3.25%. In addition, the final payment made at the earlier of the maturity of the loan or its termination included a deferred interest payment of 7.5% of the amount borrowed, resulting in a minimum annual rate of 5.98% to be paid to the lender. The term loan had prepayment fees if the Company elected to repay such loan prior to it becoming due, which penalties varied based upon the time remaining before the term loan was due. If the Company had repaid the term loan prior to the first anniversary of the term loan closing, it would have been required to pay a prepayment fee of 3% of the outstanding principal balance. The loan had no financial covenants but did contain monthly reporting requirements and gave the lender a first priority lien on all Company assets. In March 2021, the Company borrowed the first tranche of $1,500.
In October 2022, the Company paid off the entire term loan balance. As the Company chose to repay the term loan prior to the second anniversary of the term loan closing, a prepayment fee of 2% of the outstanding principal balance applied. The outstanding balance of the term loan was $0 at June 30, 2023 and December 31, 2022.
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Deferred Financing Costs
In connection with the term loan, the Company incurred $100 in expenses which were netted against the long-term portion of the term loan proceeds. The Company amortized these costs over the life of the borrowing. In the six months ended June 30, 2023 and the year ended December 31, 2022, $0 and $75, respectively of capitalized costs were amortized to interest expense.
Equipment Loans
In March 2019, the Company entered into two equipment loans with a vendor for the purchase of manufacturing machinery. The equipment loans had an aggregate principal balance of $185 at inception, with forty-eight equal monthly payments of principal and interest due beginning ninety days after taking possession of the machinery. The equipment loans are collateralized by the underlying machinery. As of June 30, 2023 and December 31, 2022, the aggregate outstanding principal balance of the equipment loans was $0 and $16, respectively. The equipment loans were fully paid off in April 2023.
8. | COMMITMENTS AND CONTINGENCIES |
Legal Proceedings—From time to time, the Company may face legal claims or actions in the normal course of business. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to its legal proceedings.
9. | LEASES |
On January 1, 2022, we adopted Accounting Standards Update (“ASU”) 2016-02 and all subsequent amendments, collectively codified in ASC Topic 842, “Leases” (“Topic 842”). The guidance requires modified retrospective adoption, either at the beginning of the earliest period presented or at the beginning of the period of adoption. We elected to apply the guidance at the beginning of the period of adoption and recorded right-of-use (ROU) leased assets of $14,302. In conjunction with this, we recorded lease liabilities, which had been discounted at our incremental borrowing rates, of $15,933. The impact of our adoption of Topic 842 on our current and deferred income taxes was immaterial. The adoption of ASC 842 had no effect on retained earnings.
The Company leases its office facility under a noncancelable operating lease agreement that expires in March 2032. Rent expense for the three and six-month periods ended June 30, 2023 was $534 and $1,069, respectively. Rent expense for the three and six-month periods ended June 30, 2022 was $565 and $1,131, respectively.
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A summary of the components of lease costs for the Company under ASC 842 for the six months ended June 30, 2023 and June 30, 2022, respectively were as follows:
June 30, | ||||||||
Lease costs | 2023 | 2022 | ||||||
Operating lease costs | $ | 1,069 | $ | 1,131 | ||||
Total lease costs | $ | 1,069 | $ | 1,131 |
Supplemental disclosure of cash flow information related to leases for the six months ended June 30, 2023 and June 30, 2022, respectively were as follows:
June 30, | ||||||||
2023 | 2022 | |||||||
Cash paid for amounts included in the measurement of operating lease liabilities (operating cash flows) | $ | 1,046 | $ | 669 |
The weighted-average remaining lease term and discount rate were as follows:
June 30, | ||||||||
2023 | 2022 | |||||||
Weighted-average remaining lease term (in years) | 9 | 10 | ||||||
Weighted-average discount rate | 8.74 | % | 8.74 | % |
The following table presents the maturity of the Company’s operating lease liabilities as of June 30, 2023:
Years Ended December 31, | ||||
2023, excluding the six months ended June 30, 2023 | $ | 1,116 | ||
2024 | 2,286 | |||
2025 | 2,358 | |||
2026 | 2,430 | |||
2027 | 2,502 | |||
Thereafter | 11,430 | |||
Total future minimum lease payments | $ | 22,122 | ||
Less imputed interest | (6,826 | ) | ||
Carrying value of lease liabilities | $ | 15,296 |
10. | INCOME TAXES |
For the three and six-month periods ended June 30, 2023 and for the year ended December 31, 2022, the Company did not record a tax provision as the Company did not earn any taxable income in either period and maintains a full valuation allowance against its net deferred tax assets.
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11. | STOCKHOLDERS’ EQUITY |
Authorized Shares
At June 30, 2023, the Company’s authorized shares consisted of 300,000,000 shares of Class A common stock, $0.0001 par value; and 22,000,000 shares of Class B common stock, $0.0001 par value; and 1,000,000 shares of preferred stock, par value of $0.0001 per share.
Common Stock
Classes of Common Stock
Class A common stock receives one vote per share. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of shares of Class A common stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the board of directors out of funds legally available for such purposes. In the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, the holders of Class A common stock are entitled to share ratably in all assets remaining after payment of our debts and other liabilities, subject to prior distribution rights of preferred stock or any class or series of stock having a preference over the Class A common stock, then outstanding, if any.
Class B common stock receives 20 votes per share and converts into Class A at a one-to-one conversion rate per share. Holders of Class B common stock will share ratably together with each holder of Class A common stock, if and when any dividend is declared by the board of directors. Holders of Class B common stock have the right to convert shares of their Class B common stock into fully paid and non-assessable shares of Class A common stock, on a one-to-one basis, at the option of the holder at any time. Upon the occurrence of certain events, holders of Class B common stock automatically convert into Class A common stock, on a one-to-one basis. In the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, the holders of Class B common stock are entitled to share ratably in all assets remaining after payment of our debts and other liabilities, subject to prior distribution rights of preferred stock or any class or series of stock having a preference over the Class B common stock, then outstanding, if any.
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The Company issues RSUs of Class A common stock to certain employees and members of the board of directors. The RSUs vest over a four-year period. The activity for common stock subject to vesting is as follows:
Shares Subject to Vesting | Weighted Average Grant Date Fair Value | |||||||
Balance of unvested shares - January 1, 2022 | 698,051 | $ | 12.54 | |||||
Granted | 3,266,548 | $ | 3.89 | |||||
Vested | (769,269 | ) | $ | 6.62 | ||||
Forfeited | (110,207 | ) | $ | 8.20 | ||||
Balance of unvested shares - January 1, 2023 | 3,085,123 | $ | 5.01 | |||||
Granted | 114,487 | $ | 2.75 | |||||
Vested | (274,951 | ) | $ | 5.10 | ||||
Forfeited | (33,508 | ) | $ | 7.92 | ||||
Balance of unvested shares - March 31, 2023 | 2,891,151 | $ | 4.88 | |||||
Granted | 2,397,010 | $ | 2.19 | |||||
Vested | (279,656 | ) | $ | 4.99 | ||||
Forfeited | (17,188 | ) | $ | 5.85 | ||||
Balance of unvested shares - June 30, 2023 | 4,991,317 | $ | 3.58 |
Total stock-based compensation related to RSUs during the three and six-month periods ended June 30, 2023 was $1,496 and $2,876, respectively. As of June 30, 2023, the total unrecognized stock-based compensation expense related to unvested RSUs aggregated $17,266 and is expected to be recognized over a weighted average period of 2.80 years. The aggregate intrinsic value of RSUs granted and vested during the six months ended June 30, 2023 and 2022, was $4,596 and $1,371, respectively. The aggregate intrinsic value of RSUs outstanding at June 30, 2023 was $9,134.
Preferred Stock
Preferred stock shares authorized may be issued from time to time in one or more series, with each series terms, voting, dividend, conversion, redemption, liquidation and other rights to be determined by the Board of Directors at the time of issuance. As of June 30, 2023, there were no shares of preferred stock issued and outstanding.
Warrants
In D8’s initial public offering on July 17, 2020, it sold units at a price of $10.00 per unit, which consisted of one D8 Class A ordinary share, $0.0001 par value, and one-half of a redeemable Public Warrant. On July 17, 2020, simultaneously with the closing of its initial public offering, D8 consummated the private placement of 8,000,000 Private Placement Warrants, each exercisable to purchase one D8 Class A ordinary share at $11.50 per share, at a price of $1.00 per Private Placement Warrant. On July 24, 2020, simultaneously with the sale of D8’s over-allotment units, D8 consummated a private sale of an additional 900,000 Private Placement Warrants. In connection with the Business Combination, 1,500,000 additional Private Placement Warrants were issued upon conversion of D8 working capital loans. In connection with the Business Combination, each issued and outstanding D8 Class A ordinary share automatically converted into one share of Class A common stock. Each warrant is exercisable to purchase one share of Class A common stock at $11.50 per share.
As of June 30, 2023, the Company had 17,248,601 Public Warrants and 10,400,000 Private Placement Warrants outstanding.
The Public Warrants became exercisable at $11.50 per share 30 days after the Closing. If and when the warrants become redeemable by the Company, the Company may exercise its redemption right even if it is unable to register or qualify the underlying securities for sale under all applicable state securities laws. The Company filed a registration statement with the SEC that was declared effective as of October 22, 2021 covering the shares of Class A common stock issuable upon exercise of the warrants and is maintaining a current prospectus relating to those shares of Class A common stock until the warrants expire, are exercised or redeemed, as specified in the warrant agreement.
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The warrants will expire five years after the completion of a Business Combination or earlier upon redemption or liquidation.
Redemption of warrants when the price per share of Class A common stock equals or exceeds $18.00. The Company may call the Public Warrants for redemption:
● | in whole and not in part; |
● | at a price of $0.01 per warrant; |
● | upon a minimum of 30 days’ prior written notice of redemption; and |
● | if, and only if, the last reported sale price of Class A common stock equals or exceeds $18.00 per share (as adjusted) for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date on which the Company sends the notice of redemption to the warrant holders. |
Redemption of warrants when the price per share of Class A common stock equals or exceeds $10.00. The Company may call the Public Warrants for redemption:
● | in whole and not in part; |
● | at a price of $0.10 per warrant; |
● | upon a minimum of 30 days’ prior written notice of redemption; provided that holders will be able to exercise their warrants on a cashless basis prior to redemption and receive that number of shares based on the redemption date and the “fair market value” of the Company’s Class A common stock; and |
● | if, and only if, the last reported sale price of Class A common stock shares equals or exceeds $10.00 per share (as adjusted) for any 20 trading days within a 30-trading day period ending three trading days before the Company sends the notice of redemption to the warrant holders. |
The Private Placement Warrants are identical to the Public Warrants underlying the Units sold in D8’s initial public offering, except that the Private Placement Warrants and the shares of Class A common stock issuable upon exercise of the Private Placement Warrants, so long as they are held by the Sponsor or its permitted transferees, (i) are not redeemable by the Company, (ii) could not (including the shares of Class A common stock issuable upon exercise of these warrants), subject to certain limited exceptions, be transferred, assigned or sold by the holders until 30 days after the completion of the initial Business Combination, (iii) may be exercised by the holders on a cashless basis and (iv) are entitled to registration rights. If the Private Placement Warrants are held by holders other than the Sponsor or its permitted transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by the holders on the same basis as the Public Warrants.
12. | Stock-based Compensation |
2021 Plan — In connection with the Closing, the Company’s stockholders approved the Vicarious Surgical Inc. 2021 Equity Incentive Plan (the “2021 Plan”), pursuant to which 6,590,000 shares of Class A common stock were reserved for future equity grants under the 2021 Plan and 11,794,074 shares of Class A common stock were reserved for issuance under the 2021 Plan upon exercise of outstanding option awards assumed by the Company in connection with the Business Combination. On June 1, 2022, the Company’s stockholders approved an amendment to the 2021 Plan, which provides for the granting of up to 6,590,000 additional shares of Class A common stock under the 2021 Plan as determined by the Board of Directors. On June 1, 2023, the Company’s stockholders approved an amendment to the 2021 Plan, which provides for the granting of up to 6,970,817 additional shares of Class A common stock under the 2021 Plan as determined by the Board of Directors.
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The 2021 Plan provides for the granting of incentive and nonqualified stock options, restricted stock, and other stock-based awards to employees, officers, directors, consultants, and advisors of the Company. Under the 2021 Plan, incentive and nonqualified stock options may be granted at not less than 100% of the fair market value of the Company’s common stock on the date of grant. If an incentive stock option is granted to an individual who owns more than 10% of the combined voting power of all classes of the Company’s capital stock, the exercise price may not be less than 110% of the fair market value of the Company’s common stock on the date of grant and the term of the option may not be longer than five years.
The 2021 Plan authorizes the Company to issue up to 31,944,891 shares of common stock (either Class A or Class B) pursuant to awards granted under the 2021 Plan. The Board of Directors administers the 2021 Plan and determines the specific terms of the awards. The contractual term of options granted under the 2021 Plan is not more than 10 years. The 2021 Plan will expire on April 13, 2031 or an earlier date approved by a vote of the Company’s stockholders or Board of Directors.
The Company grants stock options to employees at exercise prices deemed by the Board of Directors to be equal to the fair value of the common stock at the time of grant. The fair value of the Company’s stock options and warrants on the date of grant is determined by a Black-Scholes pricing model utilizing key assumptions such as common stock price, risk-free interest rate, dividend yield, expected volatility and expected life. The Company’s estimates of these assumptions are primarily based on the fair value of the Company’s stock, historical data, peer company data and judgement regarding future trends. The Company uses its publicly traded stock price as the fair value of its common stock.
During the six months ended June 30, 2023 and June 30, 2022, the Company granted options to purchase 656,930 and 1,187,691 shares, respectively, of Class A common stock, to employees and consultants with a fair value of $1,124 and $3,591 respectively, calculated using the Black-Scholes option-pricing model with the following assumptions:
Six
Months Ended June 30, | ||||||||
2023 | 2022 | |||||||
Risk-free interest rate | 3.42% - 4.17 | % | 1.95% - 2.86 | % | ||||
Expected term (in years) | 6.07 - 6.08 | 5.67 - 6.07 | ||||||
Dividend yield | % | % | ||||||
Expected volatility | 76.18% - 76.72 | % | 69.33% - 70.02 | % |
The risk-free interest rate assumption is based upon observed interest rates appropriate for the term of the related stock options. The expected life of employee and non-employee stock options was calculated using the average of the contractual term of the option and the weighted-average vesting period of the option, as the Company does not have sufficient history to use an alternative method to calculate an expected life for employees. The Company does not pay a dividend and is not expected to pay a dividend in the foreseeable future. Expected volatility for the Company’s common stock was determined based on a combination of an average of the historical volatility of a peer group of similar public companies and the Company’s own stock.
As of June 30, 2023, there was $17,934 of total gross unrecognized stock-based compensation expense related to unvested stock options. The costs remaining as of June 30, 2023 are expected to be recognized over a weighted-average period of 2.56 years.
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Total stock-based compensation expense related to all of the Company’s stock-based awards granted is reported in the statements of operations as follows:
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Research and development | $ | 805 | $ | 526 | $ | 1,666 | $ | 999 | ||||||||
Sales and marketing | 302 | 268 | 595 | 562 | ||||||||||||
General and administrative | 2,217 | 1,986 | 4,317 | 3,496 | ||||||||||||
Total | $ | 3,324 | $ | 2,780 | $ | 6,578 | $ | 5,057 |
The Company plans to generally issue previously unissued shares of common stock for the exercise of stock options.
There were 9,059,154 shares available for future equity grants under the 2021 Plan at June 30, 2023.
The option activity of the 2021 Plan for the six months ended June 30, 2023, is as follows:
Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in Years) | ||||||||||
Outstanding at January 1, 2023 | 14,192,417 | $ | 3.90 | 8.26 | ||||||||
Granted | 656,930 | 2.48 | ||||||||||
Exercised | (833,805 | ) | 0.30 | |||||||||
Forfeited, expired, or cancelled | (1,740,793 | ) | 5.13 | |||||||||
Options vested and expected to vest at June 30, 2023 | 12,274,749 | $ | 3.89 | 7.93 |
The weighted average grant date fair value of options granted during the six months ended June 30, 2023 and June 30, 2022 was $1.71 and $3.02, respectively. The aggregate intrinsic value of options exercised during the six months ended June 30, 2023 and June 30, 2022 was $1,699 and $8,569, respectively. The aggregate intrinsic value of options outstanding at June 30, 2023 was $4,306.
Common Stock Reserved for Future Issuance
As of June 30, 2023 and December 31, 2022, the Company has reserved the following shares of Class A common stock for future issuance (in thousands):
As of | ||||||||
June 30, | December 31, | |||||||
2023 | 2022 | |||||||
Common stock options outstanding | 12,275 | 14,192 | ||||||
Restricted stock units outstanding | 4,991 | 3,085 | ||||||
Shares available for issuance under the 2021 Plan | 9,059 | 3,465 | ||||||
Public warrants | 17,249 | 17,249 | ||||||
Private warrants | 10,400 | 10,400 | ||||||
Total shares of authorized Common Stock reserved for future issuance | 53,974 | 48,391 |
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13. | EMPLOYEE RETIREMENT PLAN |
The Company maintains the Vicarious Surgical Inc. 401(k) plan, under Section 401(k) of the Internal Revenue Code of 1986, as amended, covering all eligible employees. Employees of the Company may participate in the 401(k) plan after one month of service and must be 18 years of age or older. The Company offers company-funded matching contributions which totaled $213 and $571 for the three and six-month periods ended June 30, 2023, respectively. For the three and six-month periods ended June 30, 2022, the company-funded matching contributions were $192 and $399, respectively.
14. | Net Income/(Loss) Per Share |
The Company computes basic income/(loss) per share using net income/(loss) attributable to Vicarious Surgical Inc. common stockholders and the weighted-average number of common shares outstanding during each period. Diluted loss per share includes shares issuable upon exercise of outstanding stock options and stock-based awards where the conversion of such instruments would be dilutive.
For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Numerator for basic and diluted net income/(loss) per share: | ||||||||||||||||
Net income/(loss) | $ | (15,334 | ) | $ | (1,453 | ) | $ | (42,256 | ) | $ | 41,074 | |||||
Denominator for basic net income/(loss) per share: | ||||||||||||||||
Weighted average shares | 126,992,152 | 121,341,460 | 126,563,552 | 120,813,572 | ||||||||||||
Denominator for diluted net income/(loss) per share: | ||||||||||||||||
Weighted average shares | 126,992,152 | 121,341,460 | 126,563,552 | 127,847,825 | ||||||||||||
Net income/(loss) per share of Class A and Class B common stock – basic | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.33 | ) | $ | 0.34 | |||||
Net income/(loss) per share of Class A and Class B common stock – diluted | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.33 | ) | $ | 0.32 |
For the six months ended June 30, 2023, 41,433,712 potential shares of the Company’s common stock were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options and warrants were greater than or equal to the average price of the common shares and were therefore anti-dilutive.
******
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis provides information which management believes is relevant to an assessment and understanding of our unaudited condensed consolidated results of operations and financial condition. The discussion should be read in conjunction with the condensed consolidated financial statements and notes thereto contained in this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto for the year ended December 31, 2022 contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 15, 2023, and our other public reports filed with the SEC. This discussion contains forward looking statements and involves numerous risks and uncertainties, including, but not limited to, those described in the “Risk Factors” section in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022. Actual results may differ materially from those contained in any forward-looking statements. Unless the context otherwise requires, references to “we”, “us”, “our”, and “the Company” are intended to mean the business and operations of Vicarious Surgical Inc. and its consolidated subsidiaries. The condensed consolidated financial statements for the three and six-month periods ended June 30, 2023 and 2022, respectively, present the financial position and results of operations of Vicarious Surgical Inc. and its consolidated subsidiaries. In preparing this MD&A, the Company presumes that readers have access to and have read the MD&A in our Annual Report on Form 10-K, pursuant to Instruction 2 to paragraph (b) of Item 303 of Regulation S-K. Financial information is stated in thousands, except per share data.
Overview
We are combining advanced miniaturized robotics, computer science, sensing and 3D visualization to build a new category of intelligent and affordable, single-port surgical robot that virtually transports surgeons inside the patient to perform minimally invasive surgery. With our next-generation robotics technology and proprietary human-like surgical robots, we are seeking to improve patient outcomes, as well as the cost and efficacy of surgical procedures. Led by a visionary team of engineers from MIT, we intend to deliver the next generation in robotic surgery, designed to solve the shortcomings of both open surgery, as well as current manual and robot-assisted minimally invasive surgery, and transform the standard of care in surgical robotics.
We estimate there are over 45 million soft tissue surgical procedures addressable annually worldwide by our technology which represents a $150 billion market opportunity. Of these procedures, it is estimated that more than 50% are performed using open surgery, and less than 5% are performed by current robot-assisted minimally invasive surgery.
We believe this slow adoption of robot-assisted surgery has occurred because of several factors, including the following:
● | Significant Capital Investment. Legacy robotic systems require high upfront acquisition costs and burdensome annual service contracts that are often prohibitively expensive, especially in outpatient settings. Based on discussion with industry sources, we estimate these capital costs to be up to $2.0 million or more per system upfront, plus an additional 10% to 20% annually for maintenance and service contracts. |
● | Low Utilization. In addition to the significant acquisition costs, existing robotic systems create inefficiencies and increase costs to medical facilities considering adoption. Due to their large size and limited portability, existing robotic systems require the construction of a dedicated operating room, occupying valuable real estate within the hospital. Once in place, these robotic systems require extensive set-up and operating room turnover times, which limits the number of procedures that can be performed with the robotic system. |
● | Limited Capabilities. Existing robotic systems have limited capabilities and are ill-suited for many outpatient procedures. Due to their limited degrees of freedom inside the abdomen, they depend on significant, complicated, robotic motion outside the body, and they have limited ability to operate in multiple quadrants, difficulty operating on the “ceiling” of the abdomen, create collisions inside and outside of the patient’s abdomen, and restrict overall access of the operating team to the patient. |
● | Difficult to Use. Existing robotic systems require the surgeon to develop an extensive procedure plan in advance to determine appropriate incision sites and angles for each procedure, in order to avoid collisions inside and outside of the patient’s abdomen. Surgeons must develop this plan with fewer degrees of freedom than they would employ using open surgery, restricting their natural movements. Becoming proficient at manipulating these legacy robotic systems to perform the procedures they otherwise were trained to perform via open surgery requires extensive training and several dozen procedures on live patients. As these systems are maintained in dedicated, expensive, operating rooms, obtaining access to train on the system becomes a significant impediment to adoption, resulting in more open surgeries. |
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The single-port Vicarious Surgical System with advanced, miniaturized robotics and capabilities for exceptional sensing and visualization is designed to address the significant limitations of open surgery and existing single- and multi-port robotic surgical approaches to improve patient outcomes and enhance adoption by hospitals and other medical facilities. The Vicarious Surgical System is designed with a fundamentally different architecture, and proprietary “de-coupled actuators,” to overcome many of the limitations of open surgery or existing robot-assisted surgical procedures with a minimally invasive and more capable robotic system. This architecture enables unprecedented dexterity, sensing and visualization inside the abdomen through an ultra-thin support tube, providing significant improvement over existing legacy robotic systems and minimizing the complications and trauma associated with open surgery. Our goal is to leverage this architecture to eventually enable automated patient protection, which is a set of features designed to enhance patient safety, including real-time multimodal fluorescent imaging and full 3D anatomical depth mapping. We would be able to introduce these features if and when the Vicarious Surgical System, and, separately, these additional features, are approved by the Food and Drug Administration (“FDA”).
The Vicarious Surgical System has not yet been authorized by the FDA. We have had pre-submission meetings with the FDA to align on our regulatory strategy and plan to file a de novo application with the FDA for use in ventral hernia procedures as our first indication in early 2025. There are currently an estimated 3.9 million worldwide ventral hernia cases per year. Based on our pre-submission meetings with the FDA, we now expect to initiate a clinical trial in mid-2024 with an estimated 30 to 60 patients. The primary performance endpoint of our clinical trial will be the ability of the surgeon to complete the intended ventral hernia repair and our primary safety endpoint will be adverse event rate as compared to existing laparoscopic data.
Financial Highlights
We are pre-revenue generating as of June 30, 2023.
We incurred a net loss of $42,256 for the six months ended June 30, 2023 and generated net income of $41,074 for the six months ended June 30, 2022, representing a period-over-period loss of 203%. The net income for the six months ended June 30, 2022 is inclusive of a gain of $78,329 related to the change in valuation of our warrant obligations while the net loss for the six months ended June 30, 2023 is inclusive of a loss of $998 related to the change in valuation of our warrant obligations. Our loss from operations prior to the warrant gain and other income and expense items was $43,773 and $37,306 for the six months ended June 30, 2023 and 2022, respectively, representing a period-over-period loss of 17%, which was primarily due to a 20% increase in our average headcount and increased spending as we continue to develop our surgical robot. Our increase in average headcount was primarily due to an increase in research and development (“R&D”) personnel for which our average headcount increased by 21% from an average of 131 people in the six months ended June 30, 2022 to an average of 158 people for the six months ended June 30, 2023.
Other Global Developments
In 2022, various central banks around the world (including the Federal Reserve in the United States) raised interest rates. While these rate increases have not had a significant adverse impact on the Company to date, the impact of such rate increases on the overall financial markets and the economy may adversely impact the Company in the future, including by making capital more difficult and costly to obtain on reasonable terms and when needed. In addition, the global economy has experienced and is continuing to experience high levels of inflation and global supply chain disruptions. We continue to monitor these supply chain, inflation and interest rate factors, as well as the uncertainty resulting from the overall economic environment.
In addition, although we have no operations in or direct exposure to Russia, Belarus and Ukraine, we have experienced limited constraints in availability and increasing costs required to obtain some materials and supplies due, in part, to the negative impact of the Russia-Ukraine military conflict on the global economy, which contributed to global supply chain disruptions. To date, our business has not been materially impacted by the conflict; however, as the conflict continues or worsens, it may adversely impact our business, financial condition or results of operations.
Factors Affecting Results of Operations
The following factors have been important to our business and we expect them to impact our results of operations and financial condition in future periods:
Revenue
To date, we have not generated any revenue. We do not expect to generate revenue unless and until we receive FDA authorization of our product candidate. The amount of revenue, if any, from initial sales of a new product is difficult to predict and, even if we successfully commercialize our product candidate upon approval and begin generating revenue, such revenues will initially only modestly reduce our continued net losses resulting from our research and development and marketing activities which we expect to continue to increase even after market authorization is received.
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Research and Development Expenses
R&D expenses consist primarily of engineering, product development, regulatory expenses, medical affairs, and other costs associated with product candidates and technologies that are in development. These expenses include employee compensation, including stock-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation and an allocation of facility overhead expenses. Additionally, R&D expenses include internal and external costs associated with our regulatory compliance and quality assurance functions and overhead costs. We expect R&D expenses as a percentage of revenue to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trial and other related activities.
General and Administrative Expenses
General and administrative (“G&A”) expenses consist primarily of compensation for personnel, including stock-based compensation, related to executive, finance and accounting, information technology and human resource functions. Other G&A expenses include travel expenses, professional services fees (including legal, audit and tax fees), insurance costs, general corporate expenses and allocated facilities-related expenses. We expect G&A expenses to continue to increase in absolute dollars as we expand our infrastructure to both drive and support the anticipated growth due to additional legal, accounting, insurance and other expenses associated with being a public company.
Sales and Marketing Expenses
Sales and marketing (“S&M”) expenses consist primarily of compensation for personnel, including stock-based compensation, related to selling and marketing functions and physician education programs. Other S&M expenses include training, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, professional services fees and allocated facilities-related expenses. We expect S&M expenses to continue to increase in absolute dollars as we increase potential customers’ awareness of our presence and prepare our sales and marketing function for our product launch at a future, yet undetermined date.
Change in Fair Value of Warrant Liabilities
The change in fair value of the warrant liability represents the mark-to-market fair value adjustments to the outstanding Public Warrants and Private Placement Warrants assumed as part of the consummation of the Business Combination on September 17, 2021. The change in fair value of our Private Placement Warrants is primarily the result of the change in the underlying stock price of our stock used in the Black-Scholes option pricing model while the Public Warrants are marked-to-market based on their price on the New York Stock Exchange. The warrant liability was measured at fair value initially on September 17, 2021 and is remeasured at exercise, and for warrants that remain outstanding at the end of each subsequent reporting period.
Interest Income
Interest income consists primarily of interest income earned on our cash and cash equivalents and short-term investments.
Interest Expense
Interest expense consists primarily of interest incurred on our equipment loans. In 2022, interest expense also included interest incurred on our term loan which was paid off in October 2022.
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Results of Operations
The following table sets forth our historical operating results for three months ended June 30, 2023 and 2022:
Three months ended June 30, | ||||||||||||||||
(in thousands, except for per share amounts) | 2023 | 2022 | Change | % Change | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 12,714 | $ | 10,055 | $ | 2,659 | 26 | % | ||||||||
Sales and marketing | 1,666 | 1,311 | 355 | 27 | % | |||||||||||
General and administrative | 7,078 | 7,760 | (682 | ) | (9 | )% | ||||||||||
Total operating expenses | 21,458 | 19,126 | 2,332 | 12 | % | |||||||||||
Loss from operations | (21,458 | ) | (19,126 | ) | (2,332 | ) | 12 | % | ||||||||
Other income (expense): | ||||||||||||||||
Change in fair value of warrant liabilities | 5,081 | 17,601 | (12,520 | ) | (71 | )% | ||||||||||
Interest and other income | 1,044 | 101 | 943 | N/M | ||||||||||||
Interest expense | (1 | ) | (29 | ) | 28 | (97 | )% | |||||||||
Income (loss) before income taxes | (15,334 | ) | (1,453 | ) | (13,881 | ) | N/M | |||||||||
Provision for income taxes | — | — | — | N/M | ||||||||||||
Net income (loss) | $ | (15,334 | ) | $ | (1,453 | ) | $ | (13,881 | ) | N/M | ||||||
Net income (loss) per common share, basic | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.11 | ) | N/M | ||||||
Net income (loss) per common share, diluted | $ | (0.12 | ) | $ | (0.01 | ) | $ | (0.11 | ) | N/M | ||||||
Other comprehensive income/(loss): | ||||||||||||||||
Net unrealized income/(loss) on investments | (195 | ) | — | (195 | ) | N/M | ||||||||||
Other comprehensive income/(loss) | (195 | ) | — | (195 | ) | N/M | ||||||||||
Comprehensive net income/(loss) | $ | (15,529 | ) | $ | (1,453 | ) | $ | (14,076 | ) | N/M |
Comparison of the Three Months ended June 30, 2023 and 2022
Research and Development Expenses. R&D expenses increased $2,659, or 26%, to $12,714 during the three months ended June 30, 2023, compared to $10,055 during the three months ended June 30, 2022. This increase was primarily due to increases of $1,168 of personnel-related expenses, $761 in materials and supplies, $293 in lease and facility expenses, and $221 in professional services. The increase in personnel-related expense was due primarily to an increase in average headcount of 11%, from an average of 143 people in the three months ended June 30, 2022 to an average of 159 people in the three months ended June 30, 2023, with the remainder of the increase attributable to increases in wages and benefits.
Sales and Marketing Expenses. S&M expenses increased $355, or 27%, to $1,666 during the three months ended June 30, 2023, compared to $1,311 during the three months ended June 30, 2022. This increase was primarily due to an increase of $341 in professional services.
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General and Administrative Expenses. G&A expenses decreased $682, or 9%, to $7,078 during the three months ended June 30, 2023, compared to $7,760 during the three months ended June 30, 2022. This decrease was primarily due to a $666 decrease in insurance expense.
Change in Fair Value of Warrant Liabilities. The change in fair value of warrant liabilities during the three months ended June 30, 2023 was a $5,081 gain. The change in fair value of warrant liabilities during the three months ended June 30, 2022 was a $17,601 gain. These changes in fair value of the warrant liabilities resulted from the remeasurement of the public and private placement warrant liabilities at June 30, 2023 and 2022, respectively.
Interest and Other Income. Interest and other income increased by $943 to $1,044 during the three months ended June 30, 2023, compared to $101 during the three months ended June 30, 2022. The increase was primarily due to an increase in interest income from short-term investments.
Interest Expense. Interest expense decreased by $28 to $1 during the three months ended June 30, 2023, compared to $29 during the three months ended June 30, 2022. The decrease was primarily due to the term loan being paid off in full during the fourth quarter of 2022.
Income Taxes. Our income tax provision consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. Due to cumulative losses, we maintain a full valuation allowance against our U.S. and state deferred tax assets.
The following table sets forth our historical operating results for the six months ended June 30, 2023 and 2022:
Six months ended June 30, | ||||||||||||||||
(in thousands, except for per share amounts) | 2023 | 2022 | Change | % Change | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 26,070 | $ | 19,903 | $ | 6,167 | 31 | % | ||||||||
Sales and marketing | 3,626 | 2,713 | 913 | 34 | % | |||||||||||
General and administrative | 14,077 | 14,690 | (613 | ) | (4 | )% | ||||||||||
Total operating expenses | 43,773 | 37,306 | 6,467 | 17 | % | |||||||||||
Loss from operations | (43,773 | ) | (37,306 | ) | (6,467 | ) | 17 | % | ||||||||
Other income (expense): | ||||||||||||||||
Change in fair value of warrant liabilities | (998 | ) | 78,329 | (79,327 | ) | (101 | )% | |||||||||
Interest and other income | 2,517 | 109 | 2,408 | N/M | ||||||||||||
Interest expense | (2 | ) | (58 | ) | 56 | (97 | )% | |||||||||
Income (loss) before income taxes | (42,256 | ) | 41,074 | (83,330 | ) | (203 | )% | |||||||||
Provision for income taxes | — | — | — | N/M | ||||||||||||
Net income (loss) | $ | (42,256 | ) | $ | 41,074 | $ | (83,330 | ) | (203 | )% | ||||||
Net income (loss) per common share, basic | $ | (0.33 | ) | $ | 0.34 | $ | (0.67 | ) | (197 | )% | ||||||
Net income (loss) per common share, diluted | $ | (0.33 | ) | $ | 0.32 | $ | (0.65 | ) | (203 | )% | ||||||
Other comprehensive income/(loss): | ||||||||||||||||
Net unrealized income/(loss) on investments | (130 | ) | — | (130 | ) | N/M | ||||||||||
Other comprehensive income/(loss) | (130 | ) | — | (130 | ) | N/M | ||||||||||
Comprehensive net income/(loss) | $ | (42,386 | ) | $ | 41,074 | $ | (83,460 | ) | (203 | )% |
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Comparison of the Six Months ended June 30, 2023 and 2022
Research and Development Expenses. R&D expenses increased $6,167, or 31%, to $26,070 during the six months ended June 30, 2023, compared to $19,903 during the six months ended June 30, 2022. This increase was primarily due to increases of $4,058 in personnel-related expenses, $1,308 in materials and supplies, $457 in depreciation expense, and $315 in lease and facility expenses. The increase in personnel-related expense was due primarily to an increase in average headcount of 21%, from an average of 131 people in the six months ended June 30, 2022 to an average of 158 people in the six months ended June 30, 2023, with the remainder of the increase attributable to increases in wages and benefits.
Sales and Marketing Expenses. S&M expenses increased $913, or 34%, to $3,626 during the six months ended June 30, 2023, compared to $2,713 during the six months ended June 30, 2022. This increase was primarily due to increases of $494 in personnel-related expenses and $386 in professional services. The increase in personnel-related expense was due to an average headcount increase of 50%, from an average of 12 people in the six months ended June 30, 2022 to an average of 18 people for the six months ended June 30, 2023, with the remainder of the increase attributable to increases in wages and benefits.
General and Administrative Expenses. G&A expenses decreased $613, or 4%, to $14,077 during the six months ended June 30, 2023, compared to $14,690 during the six months ended June 30, 2022. This decrease was primarily due to a $1,297 decrease in insurance expense, a $156 decrease in professional fees and partially offset by increases of $383 in personnel-related expenses, a $206 increase in facility expenses, and a $210 increase in other operating costs. The increase in personnel-related expense was attributable to increases in wages and benefits.
Change in Fair Value of Warrant Liabilities. The change in fair value of warrant liabilities during the six months ended June 30, 2023 was a $998 loss. The change in fair value of warrant liabilities during the six months ended June 30, 2022 was a $78,329 gain. These changes in fair value of the warrant liabilities resulted from the remeasurement of the public and private placement warrant liabilities at June 30, 2023 and 2022, respectively.
Interest and Other Income. Interest and other income increased by $2,408 to $2,517 during the six months ended June 30, 2023, compared to $109 during the six months ended June 30, 2022. The increase was primarily due to an increase in interest income from short-term investments.
Interest Expense. Interest expense decreased by $56 to $2 during the six months ended June 30, 2023, compared to $58 during the six months ended June 30, 2022. The decrease was primarily due to the term loan being paid off in full during the fourth quarter of 2022.
Income Taxes. Our income tax provision consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. Due to cumulative losses, we maintain a full valuation allowance against our U.S. and state deferred tax assets.
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Liquidity and Capital Resources
To date, our primary sources of capital have been private placements of preferred stock prior to the Business Combination, the recapitalization with D8 and the issuance of common stock. Net cash used in our operating activities for the six months ended June 30, 2022 and the year ended December 31, 2022 was $28,966 and $61,211, respectively. As of June 30, 2023, we held cash and cash equivalents of $32,807, short-term investments of $49,976 and had an accumulated deficit of $103,897.
Excluding the non-cash impact of potential changes in the fair value of warrant liabilities, we expect net losses to continue in connection with our ongoing activities, particularly as we continue to invest in commercialization and new product development. We believe our current cash, cash equivalents and short-term investments balance of $82,783 as of June 30, 2023 will be sufficient to support our operations beyond the next twelve months from the date of issuance of these financial statements. Our future capital requirements will depend on many factors, including, but not limited to, any changes in the size, number and scope of clinical trials we may be required to conduct, the timing and conditions of market authorization (if any) for the Vicarious Surgical System, whether we are able to successfully commercialize the Vicarious Surgical System, if approved, additional product candidates we may choose to develop, fluctuations in the cost and timing of our business activities, including manufacturing, hiring and protection of our intellectual property portfolio, and the other risks and uncertainties described herein, under the caption “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K and in other filings that we make with the Securities and Exchange Commission from time to time.
We expect that we will need to obtain substantial additional funding in order to complete our clinical trials, obtain market authorization for the Vicarious Surgical System, and commercialize it, if approved. Until such time, if ever, as we can generate sufficient revenues to support our expenses, we may seek to sell additional common or preferred equity or convertible debt securities, enter into an additional credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders. Preferred equity securities or convertible debt could provide for rights, preferences or privileges senior to those of our common stock, including liquidation or other preferences that could adversely affect the rights of our existing stockholders. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our platform technologies or product candidates or grant licenses on terms that are not favorable to us, or that we would otherwise seek to develop or commercialize ourselves. Additional capital may not be available on reasonable terms, or at all, particularly given the current macroeconomic environment, including the conflict between Russia and Ukraine, diminished liquidity and credit availability, declines in consumer confidence and economic growth, rising interest rates, inflation, uncertainty about economic stability and potential for economic recession. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to significantly delay, scale back or discontinue the development, market authorization or commercialization of the Vicarious Surgical System or future product candidates, or seek collaborators at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available.
On October 7, 2022, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on October 27, 2022, on which we registered for sale up to $400 million of any combination of our Class A common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, which includes up to $100 million of Class A common stock that we may issue and sell from time to time, through Cowen and Company, LLC acting as our sales agent, pursuant to the sales agreement that we entered into with Cowen and Company, LLC on October 7, 2022 for our “at-the-market” equity program. In December 2022, we issued 3,048,781 shares of Class A common stock under our sales agreement with Cowen and Company, LLC, resulting in gross proceeds of $10.0 million. We did not issue any common stock under this shelf registration statement during the six months ended June 30, 2023.
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Cash
Our cash and cash equivalents and short-term investments balance as of June 30, 2023 was $32,807 and $49,976, respectively. Our future capital requirements may vary from those currently planned and will depend on various factors, including the timing and extent of R&D spending and spending on other strategic business initiatives.
Cash Flows Summary
Comparison of the six months ended June 30, 2023 and June 30, 2022
Six months ended June 30, | ||||||||
(in thousands) | 2023 | 2022 | ||||||
Net cash used in operating activities | $ | (33,652 | ) | $ | (28,966 | ) | ||
Net cash used in investing activities | $ | (50,184 | ) | $ | (3,578 | ) | ||
Net cash provided by financing activities | $ | 435 | $ | 233 |
Cash flows used in Operating Activities
Net cash used in operating activities during the six months ended June 30, 2023 was $33,652, attributable to a net loss of $42,256 offset by a $183 net change in our net operating assets and liabilities and non-cash items of $8,421. Non-cash items consisted of $6,578 in stock-based compensation, a gain of $998 due to the change in fair value of our warrant liabilities, $882 of depreciation and amortization, $397 for non-cash lease expense and partially offset by a loss of $434 due to the change in accrued interest and net accretion of discounts on marketable securities. The $183 change in our net operating assets and liabilities was due to a $1,698 increase in prepaid and other current assets and was partially offset by a $872 decrease in accrued expenses, a $374 decrease in lease liabilities, a $181 decrease in accounts payable, and a $88 decrease in other noncurrent assets.
Net cash used in operating activities during the six months ended June 30, 2022 was $28,966, attributable to net income of $41,074 plus a net change in our net operating assets and liabilities of $2,409 and offset by non-cash items of $72,449. Non-cash items consisted of a gain of $78,329 due to the change in fair value of our warrant liabilities, partially offset by $5,057 in stock-based compensation, $388 of depreciation and amortization and $435 for non-cash lease expense. The $2,409 change in our net operating assets and liabilities was primarily due to a $2,548 increase in prepaid and other assets and a $167 increase in accrued expenses, and was partially offset by a $333 decrease in accounts payable.
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Cash flows used in Investing Activities
Net cash used by investing activities for the six months ended June 30, 2023 was $50,184 consisting of $62,205 used for purchases of available-for-sale investments and $514 for fixed asset purchases, and partially offset by proceeds of $6,295 from sales of available-for-sale investments and $6,240 from maturities of marketable securities.
Net cash used by investing activities for the six months ended June 30, 2022 was $3,578 for fixed asset purchases consisting primarily of leasehold improvements and R&D equipment.
Cash flows provided by Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2023 was $435 consisting of $251 received for stock option exercises, $200 in proceeds from a stockholder of the Company pursuant to the application of the Section 16 short swing profit rules and partially offset by $16 of equipment loan repayments.
Net cash provided by financing activities for the six months ended June 30, 2022 was $233 consisting of $557 received for stock option exercises and partially offset by $300 of term loan repayments and $24 of equipment loan repayments.
Off-Balance Sheet Arrangements
During the periods presented, we did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities, which were established for the purpose of facilitating off-balance sheet arrangements.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the consolidated balance sheet date, as well as the reported expenses incurred during the reporting periods. Our management bases its estimates on historical experience and on various other assumptions believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates, and such differences could be material to our consolidated financial statements.
While our significant accounting policies are described in the notes to our historical condensed consolidated financial statements (see Note 2 of the accompanying condensed consolidated financial statements), we believe the following critical accounting policy requires significant judgment and estimates in the preparation of our condensed consolidated financial statements:
Stock-Based Compensation
We account for all stock-based compensation, including stock options, RSUs, warrants and other forms of equity issued as compensation, at fair value and recognize stock-based compensation expense for those equity awards, net of actual forfeitures, over the requisite service period, which is generally the vesting period of the respective award.
The fair value of our stock options on the date of grant is determined by a Black-Scholes pricing model utilizing key assumptions such as stock price, expected volatility and expected term. Our estimates of these assumptions are primarily based on the fair value of our stock, historical data, peer company data and judgment regarding future trends. We use the publicly traded stock price as the fair value of our common stock. We use the simplified method when calculating the expected term due to insufficient historical exercise data. Volatility is based on a combination of a benchmark of comparable companies within the surgical robotics and medical device industries and the Company’s own stock. The dividend yield used is zero, as we have never paid any cash dividends and do not anticipate doing so in the foreseeable future.
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Recently Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 “Summary of Significant Accounting Policies – Recently Issued Accounting Pronouncements” in our condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q.
Emerging Growth Company
Following the Business Combination, we became an “emerging growth company,” as defined in the JOBS Act. Pursuant to the JOBS Act, an emerging growth company is provided the option to adopt new or revised accounting standards that may be issued by FASB or the SEC either (i) within the same periods as those otherwise applicable to non-emerging growth companies or (ii) within the same time periods as private companies. We intend to take advantage of the exemption for complying with new or revised accounting standards within the same time periods as private companies. Accordingly, the information contained herein may be different than the information you receive from other public companies.
We also intend to take advantage of some of the reduced regulatory and reporting requirements of emerging growth companies pursuant to the JOBS Act so long as we qualify as an emerging growth company, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation, and exemptions from the requirements of holding non-binding advisory votes on executive compensation and golden parachute payments.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
Background and Remediation of Material Weaknesses
In connection with our evaluation of disclosure controls and procedures covering our consolidated financial statements as of December 31, 2022, we identified material weaknesses in our internal control over financial reporting. We have concluded that material weaknesses exist in our disclosure controls and procedures, including internal control over financial reporting, as we do not have the necessary business processes, personnel and related internal controls to operate in a manner to satisfy the accounting and financial reporting requirements of a public company. These material weaknesses manifested themselves in ways that included the improper segregation of duties relating to review of the recording of journal entries and the reconciliation of key accounts and safeguarding of assets, as well as the analysis of accounting for certain transactions and accounts, improper controls related to information technology, ineffective risk assessment process and documentation and monitoring of control processes, accounting policies and procedures.
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We are focused on designing and implementing effective internal controls measures to improve our evaluation of disclosure controls and procedures, including internal control over financial reporting, and remediate the material weaknesses. In order to remediate these material weaknesses, we have taken and plan to take the following actions:
● | the hiring and continued hiring of additional accounting, finance and legal resources with public company experience; and |
● | implementation of additional review controls and processes requiring timely account reconciliation and analyses of certain transactions and accounts. |
These actions and planned actions are subject to ongoing evaluation by management and will require testing and validation of design and operating effectiveness of internal control over financial reporting over future periods. We are committed to the continuous improvement of our internal control over financial reporting and will continue to review the internal control over financial reporting.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the fiscal quarter ended June 30, 2023, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon their evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Rules 13a-15 (e) and 15d-15 (e) under the Exchange Act) were not effective as of June 30, 2023 to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Securities and Exchange Act is recorded, processed, summarized and reported as and when required.
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control required by Rules 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the three months ended June 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
As of the date of this Quarterly Report on Form 10-Q, to our knowledge, we are not party to and our property is not subject to any material pending legal proceedings. However, from time to time, we may become involved in legal proceedings or subject to claims that arise in the ordinary course of our business activities. Regardless of the outcome, such legal proceedings or claims could have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
The following risk factor disclosure should be read in conjunction with our risk factors as described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 15, 2023. Careful consideration should be given to the following risk factors, in addition to the other information set forth in this this Quarterly Report on Form 10-Q, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes, and in other documents that we file with the SEC, in evaluating our company and our business. Investing in our securities involves a high degree of risk. If any of the events described in the following risk factors actually occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected and the trading price of our securities could decline. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of the factors that are described below and elsewhere in this this Quarterly Report on Form 10-Q.
We will not be able to obtain market authorization for or sell the Vicarious Surgical System unless and until its design is verified and validated in accordance with current good manufacturing practices.
We are in the process, but have not yet successfully completed, all the steps necessary to verify and validate the design of the Vicarious Surgical System that are required to be performed prior to market authorization and commercialization. If we are delayed or unable to complete verification and validation successfully, we will not be able to sell the Vicarious Surgical System, and we will not be able to meet our plans for the commercialization of the Vicarious Surgical System.
The clinical study process required to obtain market authorization is lengthy and expensive with uncertain outcomes. If we have difficulties with commencing or conducting clinical studies of the Vicarious Surgical System or they do not produce results necessary to support market authorization in the United States or elsewhere, we will be unable to gain market authorization for, expand the indications for or commercialize the Vicarious Surgical System and may incur additional costs or experience delays in completing, or ultimately be unable to complete, the commercialization of the Vicarious Surgical System.
The FDA may disagree with our interpretation of the data from our preclinical studies and clinical studies, or may find the clinical study design, conduct or results inadequate to prove safety or effectiveness, and may require us to pursue additional preclinical studies or clinical studies, which could further delay or prevent market authorization of the Vicarious Surgical System. The data we collect from our preclinical studies and clinical studies may not be sufficient to support FDA market authorization, and if we are unable to demonstrate the safety and effectiveness of the Vicarious Surgical System in our clinical studies, we will be unable to obtain market authorization to market the Vicarious Surgical System. In addition, FDA recommended us to make a de novo submission for the Vicarious Surgical System even though the Agency has approved certain other surgical robots based on a 510(k) pathway in the past, and there can be no assurance that we would not be required to pursue more onerous regulatory pathways than initially expected for additional product candidates, features, or indications in the future.
Clinical studies will be necessary to support our de novo application and may be necessary to support additional market authorizations for modified versions of, or additional indications for or features of, the Vicarious Surgical System. This could require the enrollment of large numbers of suitable subjects, which may be difficult to identify, recruit and maintain as participants in the clinical trial. We will likely need to conduct additional clinical studies in the future to support market authorization of the use of the Vicarious Surgical System in some foreign countries. Clinical testing is difficult to design and implement, can take many years, can be expensive, and, testing carries uncertain outcomes. The initiation and completion of any of these studies may be prevented, delayed, or halted for numerous reasons. We may experience a number of events that could adversely affect the costs, timing or successful completion of our clinical studies, including:
● | difficulties with identifying and preparing a sufficient number of clinical trial sites that provide appropriate hospital settings and staffing for Vicarious Surgical System procedures in a timely manner, which may be especially challenging outside the United States; |
● | the number of subjects or patients required for clinical studies may be larger than we anticipate, enrollment in these clinical studies may be insufficient or slower than we anticipate, and the number of clinical studies being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical studies at a higher rate than we anticipate; and |
● | we may have to amend clinical study protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an Institutional Review Board (“IRB”) and/or regulatory authorities for re-examination. |
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Patient enrollment in clinical studies and completion of patient follow-up depend on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, patient compliance, competing clinical studies and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation to other available surgical options, including any new surgical options that may be approved for the indications we are investigating. For example, patients may be discouraged from enrolling in our clinical studies if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of a product, or they may be persuaded to participate in contemporaneous clinical studies of a competitor’s product. In addition, patients participating in our clinical studies may drop out before completion of the trial or experience adverse medical events unrelated to the Vicarious Surgical System. Delays in patient enrollment or failure of patients to continue to participate in a clinical study may delay commencement or completion of the clinical trial, cause an increase in the costs of the clinical trial, or result in the failure of the clinical trial.
Clinical studies must be conducted in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject to oversight by these governmental agencies and IRBs at the medical institutions where the clinical studies are conducted. In addition, clinical studies must be conducted with supplies of our product produced under applicable cGMP requirements and other regulations. Furthermore, we rely on clinical study sites to ensure the proper and timely conduct of our clinical studies and we have limited influence over their performance. We depend on our collaborators and on medical institutions and employees to conduct our clinical studies in compliance with good clinical practice (“GCP”), requirements. If our collaborators fail to enroll participants for our clinical studies, fail to conduct the study to GCP standards or are delayed for a significant time in the execution of trials, including achieving full enrollment, we may be affected by increased costs, program delays or both. In addition, clinical studies that are conducted in countries outside the United States may result in additional delays and expenses due to increased shipment costs, additional regulatory requirements and the engagement of non-U.S. resources, and may expose us to risks associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care.
In addition, in connection with clinical trials of the Vicarious Surgical System, we or our medical institution, clinical investigator or contract research organizations (“CROs”) partners will be required to identify, retain and provide extensive training to surgeons, nurses and other staff conducting procedures using the Vicarious Surgical System. If we are unable to provide adequate training, which may be especially difficult outside the United States, this may result in serious adverse events or poor patient outcomes, which could delay our clinical trials or cause them to fail to meet primary endpoints.
We intend to conduct some of our clinical trials for the Vicarious Surgical System outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
We intend to conduct one or more of our clinical trials for the Vicarious Surgical System product candidate outside the United States. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for market authorization in the United States, the FDA will generally not grant market authorization on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements, and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving market authorization for commercialization in the applicable jurisdiction. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted, which may increase costs or time required to complete the clinical trial.
Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:
● | additional foreign regulatory requirements; |
● | foreign exchange fluctuations; |
● | compliance with foreign manufacturing, customs, shipment and storage requirements; |
● | inconsistent standards for reporting and evaluating clinical data and adverse events; |
● | COVID-19 or any other pandemic or any future public health concerns; |
● | diminished protection of intellectual property in some countries; and |
● | political instability, civil unrest, war or similar events that may jeopardize our ability to commence, conduct or complete a clinical trial and evaluate resulting data. |
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We rely on, and intend to continue to rely on third-parties to conduct, supervise and monitor our clinical trials and preclinical studies. If these third-parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, our development programs and our ability to seek or obtain market authorization for or commercialize the Vicarious Surgical System and any future product candidates may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
We are dependent on third-parties to conduct our clinical trials and preclinical studies. Specifically, we rely on, and intend to continue to rely on, medical institutions, clinical investigators, contract research organizations (“CROs”) and consultants to conduct preclinical studies and clinical trials, in each case in accordance with our clinical protocols and regulatory requirements. These CROs, investigators and other third-parties may play a significant role in the conduct and timing of these trials and subsequent collection and analysis of data. Though we expect to carefully manage our relationships with our CROs, investigators and other third-parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Further, while we have and will have agreements governing the activities of our third-party contractors, we have limited influence over their actual performance. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards and requirements, and our reliance on our CROs and other third-parties does not relieve us of our regulatory responsibilities. In addition, we and our CROs are required to comply with Good Laboratory Practice (“GLP”) and GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the Vicarious Surgical System and any future product candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs or trial sites fail to comply with applicable GLP or GCP or other requirements, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
There is no guarantee that any of our CROs, investigators or other third-parties will devote adequate time and resources to such trials or studies or perform as contractually required. If any of these third-parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated. In addition, many of the third-parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position. In addition, principal investigators for our clinical trials are expected to serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any premarket submission we submit. Any such delay or rejection could prevent us from receiving market authorization for, or commercializing the Vicarious Surgical System and any future product candidates.
Our CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances. If any of our relationships with these third-parties terminate, we may not be able to enter into arrangements with alternative third-parties on commercially reasonable terms, in a timely manner or at all. Switching or adding additional CROs, investigators and other third-parties involves additional cost and requires our management’s time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we work to carefully manage our relationships with our CROs, investigators and other third-parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
Our information technology systems, or those used by our third-party service providers, partners, contractors or consultants, may fail or suffer security breaches, and such failure could negatively affect our business, financial condition and results of operations.
We depend on our information technology systems for the efficient functioning of our business, including the manufacture, distribution and maintenance of our products, as well as for accounting, data storage, compliance, purchasing, inventory management and other related functions. We do not have redundant information technology in all aspects of our systems at this time. Despite the implementation of security and back-up measures, our information technology systems as well as those of our third-party partners, consultants, contractors, suppliers, and service providers, may be vulnerable to attack, damage and interruption from physical or electronic break-ins, accidental or intentional exposure of our data by employees or others with authorized access to our networks, computer viruses, malware, ransomware, malicious code, phishing attacks and other social engineering schemes, denial or degradation of service attacks, attacks by sophisticated nation-state and nation-state-supported actors, supply chain attacks, natural disasters, terrorism, war, telecommunication and electrical failure, denial of service, and other cyberattacks or disruptive incidents that could result in unauthorized access to, use or disclosure of, corruption of, or loss of sensitive, and/or proprietary data, including health-related and other personal information, and could subject us to significant liabilities and regulatory and enforcement actions, and reputational damage.
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Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period. Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.
We and certain of our partners or service providers are from time to time subject to cyberattacks and security incidents. While we do not believe that we have experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our business operations, whether due to a loss, corruption or unauthorized disclosure of our trade secrets, personal information or other proprietary or sensitive information or other similar disruptions. Additionally, theft of our intellectual property or proprietary business information could require substantial expenditures to remedy. Such theft could also lead to loss of intellectual property rights through disclosure of our proprietary business information, and such loss may not be capable of remedying. If we or our third-party partners, consultants, contractors, suppliers, or service providers were to suffer an attack or breach, for example, that resulted in the unauthorized access to or use or disclosure of health-related or other personal information, we may have to notify consumers, partners, collaborators, government authorities, and the media, and may be subject to investigations, civil penalties, administrative and enforcement actions, and litigation, any of which could harm our business and reputation. Likewise, we rely on third parties to conduct clinical trials, and similar events relating to their computer systems and networks could also have a material adverse effect on our business.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or systems or data or systems of our commercial partners, or inappropriate or unauthorized access to or disclosure or use of confidential, proprietary, or other sensitive, personal, or health information, we could incur liability and suffer reputational harm. Failure to maintain or protect our information technology systems effectively could negatively affect our business, financial condition and results of operations. We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.
Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell the Vicarious Surgical System and subject us to possible litigation.
A portion of the products or technologies licensed, developed and/or distributed by us incorporate so-called “open source” software and we may incorporate open source software into other products in the future. Such open source software is generally licensed by its authors or other third parties under open source licenses. Some open source licenses contain requirements that we disclose source code for modifications we make to the open source software and that we license such modifications to third parties at no cost. In some circumstances, distribution of our software in connection with open source software could require that we disclose and license some or all of our proprietary code in that software, as well as distribute our software that uses particular open source software at no cost to the user. We monitor our use of open source software in an effort to avoid uses in a manner that would require us to disclose or grant licenses under our proprietary source code; however, there can be no assurance that such efforts will be successful. Open source license terms are often ambiguous and such use could inadvertently occur. There is little legal precedent governing the interpretation of many of the terms of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations regarding the Vicarious Surgical System and our technologies. Companies that incorporate open source software into their products have, in the past, faced claims seeking enforcement of open source license provisions and claims asserting ownership of open source software incorporated into their product. If an author or other third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of the Vicarious Surgical System. In addition, if we combine our proprietary software with open source software in certain ways, under some open source licenses, we could be required to release the source code of our proprietary software, which could substantially help our competitors develop products that are similar to or better than ours and otherwise adversely affect our business. These risks could be difficult to eliminate or manage, and, if not addressed, could harm our business, financial condition and results of operations.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Equity Securities
Not applicable.
Issuer Purchases of Equity Securities
We did not repurchase any of our equity securities during the six months ended June 30, 2023.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
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Item 6. Exhibits.
* |
Filed herewith. | |
† |
The certifications furnished in Exhibit 32 hereto are deemed to accompany this Quarterly Report and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference. | |
+ | Management contract or compensatory plan or arrangement. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned thereunto duly authorized.
VICARIOUS SURGICAL INC. | ||
July 28, 2023 | By: | /s/ Adam Sachs |
Adam Sachs | ||
Chief Executive Officer and President | ||
(Principal Executive Officer) | ||
July 28, 2023 | By: | /s/ William Kelly |
William Kelly | ||
Chief Financial Officer | ||
(Principal Financial Officer and Principal Accounting Officer) |
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