Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Jul. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | RxSIGHT, INC. | |
Entity Central Index Key | 0001111485 | |
Entity Tax Identification Number | 94-3268801 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity File Number | 001-40690 | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 100 Columbia | |
Entity Address, City or Town | Aliso Viejo | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92656 | |
City Area Code | 949 | |
Local Phone Number | 521-7830 | |
Trading Symbol | RXST | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 27,638,899 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 24,004 | $ 24,361 |
Short-term investments | 104,616 | 134,971 |
Accounts receivable | 6,884 | 4,862 |
Inventories | 11,622 | 8,032 |
Prepaid and other current assets | 2,802 | 4,069 |
Total current assets | 149,928 | 176,295 |
Property and equipment, net | 11,083 | 11,217 |
Operating leases right-of-use assets | 4,704 | 4,284 |
Restricted cash | 811 | 811 |
Other assets | 188 | 114 |
Total assets | 166,714 | 192,721 |
Current liabilities: | ||
Accounts payable | 3,277 | 1,689 |
Accrued expenses and other current liabilities | 7,877 | 7,859 |
Lease liabilities | 1,842 | 1,529 |
Total current liabilities | 12,996 | 11,077 |
Long-term lease liabilities | 3,851 | 3,642 |
Term loan, net | 39,881 | 39,760 |
Total liabilities | 56,728 | 54,479 |
Commitments and contingencies (Note 9) | ||
Stockholders' deficit: | ||
Common stock, $0.001 par value, 900,000,000 shares authorized, 27,631,479 shares issued and outstanding as of June 30, 2022 and 27,366,746 shares issued and outstanding as of December 31, 2021 | 27 | 27 |
Preferred stock, $0.001 par value, 100,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Additional paid-in capital | 623,746 | 617,511 |
Accumulated other comprehensive loss | (183) | (20) |
Accumulated deficit | (513,604) | (479,276) |
Total stockholders' deficit | 109,986 | 138,242 |
Total liabilities and stockholders' equity | $ 166,714 | $ 192,721 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 | Jul. 29, 2021 |
Common stock par value (USD per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 900,000,000 | 900,000,000 | 900,000,000 |
Common stock issued (in shares) | 27,631,479 | 27,366,746 | |
Common stock outstanding (in shares) | 27,631,479 | 27,366,746 | |
Preferred stock par value per share | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized | 100,000,000 | 100,000,000 | |
Preferred Shares Issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Convertible Preferred Stock [Member] | |||
Preferred stock par value per share | $ 0.001 | ||
Preferred stock, shares authorized | 100,000,000 | ||
Preferred stock, shares outstanding | 14,376,272 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Sales | $ 11,360 | $ 4,897 | $ 20,301 | $ 8,381 |
Cost of sales | 6,572 | 5,709 | 11,752 | 8,074 |
Gross profit (loss) | 4,788 | (812) | 8,549 | 307 |
Operating expenses: | ||||
Selling, general and administrative | 14,388 | 6,502 | 28,008 | 12,113 |
Research and development | 6,192 | 6,563 | 12,911 | 13,206 |
Total operating expenses | 20,580 | 13,065 | 40,919 | 25,319 |
Loss from operations | (15,792) | (13,877) | (32,370) | (25,012) |
Other income (expense), net: | ||||
Change in fair value of warrants | 0 | 1,214 | 0 | 1,214 |
Expiration of warrant | 0 | 0 | 0 | 5,018 |
Interest expense | (1,136) | (826) | (2,196) | (1,524) |
Interest and other income | 196 | 15 | 242 | 32 |
Loss before income taxes | (16,732) | (13,474) | (34,324) | (20,272) |
Income tax expense | 0 | 3 | 4 | 10 |
Net loss | (16,732) | (13,477) | (34,328) | (20,282) |
Other comprehensive loss | ||||
Unrealized (loss) gain on short-term investments | (76) | (4) | (150) | 3 |
Foreign currency translation (loss) gain | (9) | 1 | (13) | (3) |
Total other comprehensive loss | (85) | (3) | (163) | 0 |
Comprehensive loss | $ (16,817) | $ (13,480) | $ (34,491) | $ (20,282) |
Net loss per share: | ||||
Attributable to common stock, basic | $ (0.61) | $ (3.28) | $ (1.25) | $ (5) |
Attributable to common stock, diluted | $ (0.61) | $ (3.53) | $ (1.25) | $ (5.23) |
Weighted-average shares used in computing net loss per share: | ||||
Attributable to common stock, basic | 27,559,908 | 4,106,403 | 27,493,130 | 4,052,920 |
Attributable to common stock, diluted | 27,559,908 | 4,166,439 | 27,493,130 | 4,113,249 |
Series G Preferred Stock [Member] | ||||
Net loss per share: | ||||
Attributable to Series G common stock, basic and diluted | $ (0.32) | $ (0.48) | ||
Weighted-average shares used in computing net loss per share: | ||||
Attributable to Series G common stock, basic and diluted | 1 | 1 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Redeemable Common Stock, Stock Options, Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Total | Redeemable Common Stock | Notes Receivable for Redeemable Common Stock Issued | Redeemable Stock Options | Redeemable Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Notes Receivable for Common Stock Issued | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Temporary Equity, Beginning Balance, Amount at Dec. 31, 2020 | $ 80,780 | $ 803 | $ 53,085 | $ 353,300 | ||||||
Temporary Equity, Beginning Balance, Shares at Dec. 31, 2020 | 3,813,450 | 14,376,272 | ||||||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2020 | $ (430,591) | $ (3) | $ (430,588) | |||||||
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2020 | 1 | |||||||||
Exercise of stock options | $ 6,922 | (5,715) | ||||||||
Exercise of stock options, shares | 280,545 | |||||||||
Stock-based compensation expense | 1,239 | $ 1,239 | ||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | 7 | 7 | ||||||||
Foreign currency translation adjustment | (4) | (4) | ||||||||
Change in notes receivable for common stock issued | (14) | |||||||||
Reclassification of 4,093,995 shares of redeemable common stock to 4,093,995 shares of common stock | 86,885 | $ (87,702) | 817 | $ 4 | 87,698 | $ (817) | ||||
Reclassification of 4,093,995 shares of redeemable common stock to 4,093,995 shares of common stock, shares | (4,093,995) | 4,093,995 | ||||||||
Reclassification of redeemable common stock options to common stock options | 47,370 | (47,370) | 47,370 | |||||||
Net loss | (6,805) | (6,805) | ||||||||
Temporary Equity, Ending Balance, Amount at Mar. 31, 2021 | $ 353,300 | |||||||||
Temporary Equity, Ending Balance, Shares at Mar. 31, 2021 | 14,376,272 | |||||||||
Stockholders' Equity, Ending Balance, Amount at Mar. 31, 2021 | (301,899) | $ 4 | 136,307 | (817) | (437,393) | |||||
Stockholders' Equity, Ending Balance, Shares at Mar. 31, 2021 | 4,093,996 | |||||||||
Temporary Equity, Beginning Balance, Amount at Dec. 31, 2020 | $ 80,780 | $ 803 | $ 53,085 | $ 353,300 | ||||||
Temporary Equity, Beginning Balance, Shares at Dec. 31, 2020 | 3,813,450 | 14,376,272 | ||||||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2020 | (430,591) | (3) | (430,588) | |||||||
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2020 | 1 | |||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | 3 | |||||||||
Net loss | (20,282) | |||||||||
Temporary Equity, Ending Balance, Amount at Jun. 30, 2021 | $ 353,300 | |||||||||
Temporary Equity, Ending Balance, Shares at Jun. 30, 2021 | 14,376,272 | |||||||||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2021 | (313,396) | $ 4 | 137,838 | (365) | (3) | (450,870) | ||||
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2021 | 4,124,211 | |||||||||
Temporary Equity, Beginning Balance, Amount at Mar. 31, 2021 | $ 353,300 | |||||||||
Temporary Equity, Beginning Balance, Shares at Mar. 31, 2021 | 14,376,272 | |||||||||
Stockholders' Equity, Beginning Balance, Amount at Mar. 31, 2021 | (301,899) | $ 4 | 136,307 | (817) | (437,393) | |||||
Stockholders' Equity, Beginning Balance, Shares at Mar. 31, 2021 | 4,093,996 | |||||||||
Exercise of stock options | 125 | 125 | ||||||||
Exercise of stock options, shares | 30,215 | |||||||||
Stock-based compensation expense | 1,406 | 1,406 | ||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | (4) | (4) | ||||||||
Foreign currency translation adjustment | 1 | 1 | ||||||||
Change in notes receivable for common stock issued | 452 | 452 | ||||||||
Net loss | (13,477) | (13,477) | ||||||||
Temporary Equity, Ending Balance, Amount at Jun. 30, 2021 | $ 353,300 | |||||||||
Temporary Equity, Ending Balance, Shares at Jun. 30, 2021 | 14,376,272 | |||||||||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2021 | (313,396) | $ 4 | 137,838 | $ (365) | (3) | (450,870) | ||||
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2021 | 4,124,211 | |||||||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2021 | $ 138,242 | $ 27 | 617,511 | (20) | (479,276) | |||||
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2021 | 27,366,746 | 27,366,746 | ||||||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 145,922 | |||||||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Amount | $ 308 | 308 | ||||||||
Shares redeemed for employee tax withholdings | (26,983) | |||||||||
Value of shares redeemed for employee tax withholdings | (362) | (362) | ||||||||
Stock-based compensation expense | 2,649 | 2,649 | ||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | (74) | (74) | ||||||||
Foreign currency translation adjustment | (4) | (4) | ||||||||
Net loss | (17,596) | (17,596) | ||||||||
Stockholders' Equity, Ending Balance, Amount at Mar. 31, 2022 | 123,163 | $ 27 | 620,106 | (98) | (496,872) | |||||
Stockholders' Equity, Ending Balance, Shares at Mar. 31, 2022 | 27,485,685 | |||||||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2021 | $ 138,242 | $ 27 | 617,511 | (20) | (479,276) | |||||
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2021 | 27,366,746 | 27,366,746 | ||||||||
Conversion of preferred stock to common stock upon initial public offering, net of fractional shares settled (in shares) | 4,093,995 | |||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | $ (150) | |||||||||
Net loss | (34,328) | |||||||||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2022 | $ 109,986 | $ 27 | 623,746 | (183) | (513,604) | |||||
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2022 | 27,631,479 | 27,631,479 | ||||||||
Stockholders' Equity, Beginning Balance, Amount at Mar. 31, 2022 | $ 123,163 | $ 27 | 620,106 | (98) | (496,872) | |||||
Stockholders' Equity, Beginning Balance, Shares at Mar. 31, 2022 | 27,485,685 | |||||||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 99,743 | |||||||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Amount | 277 | 277 | ||||||||
Stock-based compensation expense | 2,904 | 2,904 | ||||||||
Unrealized gain on short-term investments and cash equivalents, net of tax | (76) | (76) | ||||||||
Foreign currency translation adjustment | (9) | (9) | ||||||||
Shares issued for the employee stock purchase plan, shares | 46,051 | |||||||||
Shares issued for the employee stock purchase plan | 459 | 459 | ||||||||
Net loss | (16,732) | (16,732) | ||||||||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2022 | $ 109,986 | $ 27 | $ 623,746 | $ (183) | $ (513,604) | |||||
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2022 | 27,631,479 | 27,631,479 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Redeemable Common Stock, Stock Options, Convertible Preferred Stock and Stockholders' Deficit (Unaudited) (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2021 shares | |
Statement of Stockholders' Equity [Abstract] | |
Redeemable common stock reclassified, shares | 4,093,995 |
Common stock after reclassification of redeemable common stock, shares | 4,093,995 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating Activities: | ||
Net loss | $ (34,328) | $ (20,282) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,025 | 1,944 |
Amortization of right-of-use lease assets | 56 | 15 |
Amortization of debt issuance costs and premium | 265 | 229 |
Change in fair value of warrants | 0 | (1,214) |
Gain on expiration of warrant | 0 | (5,018) |
Amortization of discount on short-term investments | (231) | (15) |
Stock-based compensation | 5,553 | 2,645 |
Provision for excess and obsolete inventory | 120 | 1,749 |
Change in operating assets and liabilities: | ||
Accounts receivable | (2,022) | (1,071) |
Inventories | (3,710) | (2,004) |
Prepaid and other assets | 1,099 | (1,250) |
Accounts payable | 1,348 | 1,195 |
Accrued expenses and other liabilities | 17 | 846 |
Net cash used in operating activities | (29,808) | (22,231) |
Investing Activities: | ||
Purchases of property and equipment | (1,451) | (1,321) |
Maturities of short-term investments | 135,000 | 40,000 |
Purchases of short-term investments | (104,564) | (4,999) |
Net cash provided by investing activities | 28,985 | 33,680 |
Financing Activities: | ||
Proceeds from term loan | 15,000 | |
Payments of debt issuance costs | (142) | (122) |
Payments for employee taxes related to stock compensation | (362) | |
Principal payments on finance lease liabilities | (60) | (16) |
Payments of deferred offering costs | (242) | |
Change in notes receivables for redeemable common stock issued | 439 | |
Proceeds from issuance of common stock | 1,044 | 1,332 |
Net cash (used in) provided by financing activities | 480 | 16,391 |
Effect of foreign exchange rate on cash, cash equivalents and restricted cash | (14) | (3) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (357) | 27,837 |
Cash, cash equivalents and restricted cash - beginning of period | 25,172 | 14,455 |
Cash, cash equivalents and restricted cash - end of period | 24,815 | 42,292 |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | 1,023 | 598 |
Cash paid for income taxes | 3 | 14 |
Cash paid for interest on financing leases | 3 | 3 |
Cash paid for interest on term loan | 1,904 | 1,291 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating lease | 1,090 | |
Finance Lease | 288 | |
Lease obligations recorded for right-of-use assets: | ||
Operating lease | 1,090 | |
Finance Lease | 256 | |
Acquisition of property and equipment included in accounts payable and accrued expenses and other current liabilities | $ 238 | 76 |
Deferred offering costs included in accrued expenses | (1,233) | |
Payment-in-kind interest income added to principal of notes receivable | 26 | |
Reclassification of 4,093,995 shares of redeemable common stock to 4,093,995 shares of common stock | 87,702 | |
Reclassification of redeemable common stock options to common stock options | $ 47,370 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) | 6 Months Ended |
Jun. 30, 2022 shares | |
Statement of Cash Flows [Abstract] | |
Redeemable common stock reclassified | 4,093,995 |
Common stock after reclassification of redeemable common stock | 4,093,995 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Note 1 - Organization and Basis of Presentation Description of Business RxSight®, Inc. (the “Company”) is a Delaware corporation headquartered in Aliso Viejo, California with one wholly owned subsidiary located in Amsterdam, Netherlands. The wholly owned subsidiary has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany. The Company is engaged in the research and development, manufacture and sale of light adjustable intraocular lenses used in cataract surgery along with capital equipment used with the lenses. The Company’s products, which include the light adjustable lens (“LAL”®) and a specially designed machine for delivering light to the eye, the Light Delivery Device (“LDD”), are approved by the United States (“U.S.”) Food and Drug Administration (“FDA”) for sale in the U.S. and have regulatory approval in the U.S and Europe. The Company began marketing its products in the U.S. during the second quarter of 2019 and in Europe during the third quarter of 2019. The LAL is a premium intraocular lens (“IOL”) which is partially reimbursable under Medicare. The Company competes with other IOLs in the premium market in the U.S. and Europe. The accompanying unaudited condensed consolidated financial statements include the accounts of RxSight, Inc. and its wholly owned subsidiaries, RxSight, B.V., and RxSight GmbH. All significant inter-company balances and transactions have been eliminated in consolidation. Basis of Presentation and Principles of Consolidation The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The December 31, 2021 balance sheet data was derived from audited financial statements; however, the accompanying notes to the condensed consolidated financial statements do not include all of the annual disclosures required under GAAP and should be read in conjunction with the Company’s 2021 Annual Report on Form 10-K filed with the SEC on March 8, 2022. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. Initial Public Offering ( “ IPO ” ) and Reverse Stock Split On July 22, 2021, the Company’s Board of Directors (“Board”) approved an amendment to the Company’s certificate of incorporation to effect a reverse split of shares of the Company’s common stock, excluding Series G and Series W common stock, and convertible preferred stock on a 1-for-10.33 basis (“Reverse Stock Split”). The par values of the common stock and convertible preferred stock were not adjusted as a result of the Reverse Stock Split. The Reverse Stock Split was effected on July 23, 2021. Accordingly, all common stock, excluding Series G and Series W common stock, options to purchase common stock, convertible preferred stock, share data, per share data and related information contained in the accompanying condensed consolidated financial statements and notes have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The Reverse Stock Split resulted in an adjustment to the convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. On July 29, 2021 , the Company completed its IPO which resulted in the issuance and sale of 8,248,549 shares of its common stock at a price of $ 16.00 per share. The aggregate net proceeds from the offering, which included 898,549 common shares sold upon the partial exercise of the underwriters’ over-allotment option, after deducting underwriting discounts and commissions of $ 9.2 million and other offering costs of $ 3.2 million, were approximately $ 119.6 million. On July 29, 2021, the Company amended and restated its certificate of incorporation and bylaws which provide for, among other things, the Company’s authorized capital stock to consist of 900,000,000 shares of common stock, par value $ 0.001 per share, and 100,000,000 shares of convertible preferred stock, par value $ 0.001 per share. The amended and restated certificate of incorporation defines the voting rights, dividends, liquidation rights and preferences of each class of stock. Immediately prior to the completion of the IPO, (i) 14,376,272 outstanding shares of the Company's convertible preferred stock were converted into an aggregate of 14,725,309 shares of common stock and (ii) 225,945 warrants to purchase Series H convertible preferred stock were exercised and converted into 100,261 shares of common stock. Liquidity and Financial Position As of June 30, 2022 and December 31, 2021 the Company had cash, cash equivalents and short-term investments of $ 128.6 million and $ 159.3 million, respectively. The Company began generating revenue from its principal operations in 2019. The Company has a limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. For the three months ended June 30, 2022 and 2021 the Company incurred losses from operations of $ 15.8 million and $ 13.9 million, respectively. For the six months ended June 30, 2022 and 2021, the Company incurred losses from operations of $ 32.4 million and $ 25.0 million, respectively. Due to the Company’s continuing research and development activities and expansion of its sales and marketing activities, the Company expects to continue to incur net operating losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon gaining market acceptance of the Company’s products and achieving a level of revenues adequate to support the Company’s cost structure. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company believes that existing cash resources will be sufficient to meet projected operating requirements for at least 12 months from the date of issuance of the accompanying condensed consolidated financial statements, though the Company expects to continue to incur operating losses and negative cash flows. The Company plans to continue to fund its losses from operations using its cash, cash equivalents and short-term investments as of June 30, 2022 and meet its future capital funding needs through equity or debt financings, other third-party funding, collaborations, strategic alliances and licensing arrangements or a combination of these. If the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. Any future debt financing into which the Company enters may impose additional covenants that restrict operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity raise may contain terms that are not favorable to the Company or its stockholders. If the Company is required to enter into collaborations and other arrangements to address its liquidity needs, it may have to give up certain rights that limit its ability to develop and commercialize product candidates or may have other terms that are not favorable to the Company or its stockholders, which could materially and adversely affect its business and financial prospects. There can be no assurance that the Company will be able to obtain additional financing on acceptable terms, or at all. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects. |
Summary of Accounting Policies
Summary of Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Accounting Policies | Note 2 - Summary of Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make informed estimates, judgments and assumptions that affect the reported amounts in the condensed consolidated financial statements and disclosures in the accompanying notes as of the date of the accompanying condensed consolidated financial statements. On an on-going basis, management evaluates the most critical estimates and assumptions for continued reasonableness. Actual results may differ materially from the estimates used in the preparation of the accompanying condensed consolidated financial statements under different assumptions or conditions. Significant Accounting Policies There have been no significant changes to the accounting policies during the six months ended June 30, 2022 , as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K filed with the SEC on March 8, 2022. Cash Equivalents Cash equivalents consist of investments in money market accounts. The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase that can be liquidated without prior notice or penalty to be cash equivalents. Short-term Investments Short-term investments are classified based on the maturity date of the related securities. Based on the nature of the assets, the Company’s short-term investments, which are government securities, are classified as available-for-sale and are recorded at their estimated fair value as determined by prices for identical or similar securities at the balance sheet date. The Company’s short-term investments consist of Level 2 financial instruments in the fair value hierarchy. Unrealized gains and losses are recorded as a component of Other Comprehensive Loss within Stockholders’ Equity on the condensed consolidated balance sheets. Realized gains and losses are included as other income (expense) in the accompanying condensed consolidated statements of operations and comprehensive loss. The cost basis for realized gains and losses on available-for-sale securities is determined on a specific identification basis. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such determination at each balance sheet date. The Company periodically reviews its investments for unrealized losses other than credit losses and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. In determining whether the carrying value is recoverable, management considers the following factors: • whether the investment has been in a continuous loss position for over 12 months; • the duration to maturity of investments; • intention and ability to hold the investment to maturity and if it is not more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. The Company had $ 160,000 and $ 9,000 of unrealized losses related to short-term investments as of June 30, 2022 and December 31, 2021 , respectively. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments which potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company’s policy is to invest cash in institutional money market funds and marketable securities of the U.S. government to limit the amount of credit exposure. The Company currently maintains a portfolio of cash equivalents and short-term investments in money market funds and U.S. treasury bills. Additionally, the Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. The Company has not experienced material losses on cash equivalents and short-term investments. The Company’s products require approval from the FDA and foreign regulatory agencies before commercial sales can commence. There can be no assurance that the Company’s products will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on the Company’s business and may impact business in the future. In addition, after approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the device approval process. The Company is subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of the Company's products, product liability and the need to obtain additional financing. The Company is subject to the risks related to the global pandemic associated with COVID-19, including local, state, federal and other world-wide mandates imposed to reduce the spread of the virus which could interrupt or reduce the number of cataract surgeries, limit access to ambulatory surgery centers, doctors’ offices and manufacturing facilities, and the expansion of global lead times, particularly in Europe and Asia, leading to a supply interruption from the Company's suppliers. In addition, the Company is currently experiencing inflation and longer lead times and limited availability in its supply chain for certain components and has continued exposure to price and supply risk related to anticipated purchases of certain commodities, materials and products used in its business. Accounts Receivable The Company has a diverse customer base and as of June 30, 2022 and December 31, 2021 the Company had no customers who individually accounted for more than 10 % of accounts receivable. The Company maintains an allowance for credit losses resulting from the inability of its customers, including ambulatory surgery centers, to make required payments. After evaluation of the collectability of accounts receivable, the Company did no t record any significant allowance for credit losses as of June 30, 2022 or December 31, 2021 . Fair Value of Financial Instruments The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company’s financial instruments consist principally of cash, cash equivalents, short-term investments, accounts receivable, accounts payable, operating lease liabilities and a term loan. Fair value is measured as the price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques that are consistent with the market, income or cost approach are used to measure fair value. The fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels: Level 1—Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities. Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability, for substantially the full term of the asset or liability, through correlation with market data. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and inputs to valuation models or other pricing methodologies that do not require significant judgment because the inputs used in the model, such as interest rates and volatility, can be corroborated by readily observable market data. Level 3—One or more significant inputs that are unobservable and supported by little or no market activity and reflect the use of significant management judgment and assumptions. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. These include the Black-Scholes option-pricing model which uses inputs such as expected volatility, risk-free interest rate and expected term to determine fair market valuation. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented. Inventories Inventories consist of raw materials, work-in-process and finished goods. Raw materials are comprised of chemicals and parts used in the production of the Company's lenses, cartridges, and LDDs. Finished goods are comprised of lenses, cartridges, accessories and LDDs. Inventories are valued at the lower of cost or net realizable value. Cost is computed using standard cost, which approximates actual cost on a first-in, first-out basis. The carrying value of inventories is reviewed for potential impairment whenever indicators suggest that the cost of inventories exceeds the carrying value and management adjusts the inventories to its net realizable value. The cost of finished goods and work-in-process is comprised of raw materials, direct labor, other direct costs and related production overhead to the extent that these costs do not exceed the net realizable value of the goods produced. The Company periodically reviews inventories for potential impairment, estimated losses from obsolescence, material expirations or unmarketable inventories or excess inventories and writes down the cost of inventories to net realizable value at the time such determinations are made. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose. Leases Lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized when the Company takes possession of the leased property (“Commencement Date”) based on the present value of lease payments over the lease term. The Company estimates the incremental borrowing rate based upon the cost of its own debt financing, current market interest rates and quoted offerings or the rate implicit in the lease. Operating lease right-of-use assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The lease terms used to calculate the right-of-use asset and related lease liability include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Rent expense on noncancelable leases containing known future scheduled rent increases is recorded on a straight-line basis over the term of the respective leases beginning on the Commencement Date. The difference between rent expense and rent paid is accounted for as a component of operating lease right-of-use assets on the accompanying condensed consolidated balance sheets. Landlord improvement allowances and other such lease incentives are recorded as property and equipment and as reduction of the right-of-use leased assets and are amortized on a straight-line basis as a reduction to operating lease costs. Leases with an initial term of 12 months or less are expensed as incurred and are not recorded as right-of-use assets on the condensed consolidated balance sheets. Net Loss per Share The Company computes basic net loss per share for common stock using the two-class method required for companies with participating securities based upon the weighted-average number of common shares outstanding during the period. Diluted net loss per share assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options, warrants and the shares issuable upon the conversion of the preferred stock. For stock options and preferred stock, the calculation of diluted loss per share requires an adjustment for the additional share of undistributed earnings. For warrants that are recorded as a liability in the condensed consolidated balance sheets, the calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to the loss per share for the period, an adjustment is made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. The following tables show the computation of basic and diluted net loss per share for the three and six months ended June 30, 2022 and 2021 (amounts in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Common Stock Numerator: Net loss attributable to stockholders, basic $ ( 16,732 ) $ ( 13,477 ) $ ( 34,328 ) $ ( 20,282 ) Effect of dilutive securities: Preferred stock warrants — 1,214 — 1,214 Net loss available to stockholders, $ ( 16,732 ) $ ( 14,691 ) $ ( 34,328 ) $ ( 21,496 ) Denominator: Weighted-average shares outstanding, basic 27,559,908 4,106,403 27,493,130 4,052,920 Effect of dilutive securities: Preferred stock warrants — 60,036 — 60,329 Weighted-average shares, diluted 27,559,908 4,166,439 27,493,130 4,113,249 Basic net loss per share $ ( 0.61 ) $ ( 3.28 ) $ ( 1.25 ) $ ( 5.00 ) Diluted net loss per share $ ( 0.61 ) $ ( 3.53 ) $ ( 1.25 ) $ ( 5.23 ) Series G Common Stock Numerator: Net loss available to stockholder, basic $ — $ ( 0.32 ) $ — $ ( 0.48 ) Effect of dilutive securities: Preferred stock warrants — — — — Net loss attributable to stockholder, diluted $ — $ ( 0.32 ) $ — $ ( 0.48 ) Denominator: Weighted-average shares outstanding, basic and diluted 1 1 Basic net loss per share — $ ( 0.32 ) — $ ( 0.48 ) Diluted net loss per share — $ ( 0.32 ) — $ ( 0.48 ) The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders because their impact under the “treasury stock method” and “if-converted method” was anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Convertible preferred stock — 14,850,993 — 14,850,993 Stock options issued and outstanding under the Calhoun Vision, Inc. 2006 Stock Plan, Calhoun Vision, Inc. 2015 Equity Incentive Plan and the 2021 Equity Incentive Plan 1,942,092 4,610,950 1,973,913 4,368,665 Restricted stock units 65,825 — 48,188 — Stock issuable in offering period under the Employee Stock Purchase Plan 48,373 — 47,496 — Revenue Recognition The Company’s revenue is generated from the sale of LALs used in cataract surgery along with a specifically designed machine for delivering light to the eye, the LDD, to adjust the lens post-surgery, as needed. Revenue is recognized from sales of products in the U.S. and Europe. Customers are primarily comprised of ambulatory surgery centers, hospitals, and physician private practices. The Company recognizes revenues when promised goods or services are transferred to customers at a transaction price that reflects the consideration to which the Company expects to be entitled in exchange for those goods and services. Specifically, the Company applies the following five steps to recognize revenue: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies a performance obligation. The Company applies the five-step model to contracts when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods promised within each customer contract to determine the individual deliverables in its product offerings as separate performance obligations and assesses whether each promised good or service is distinct. The transaction price is determined based on the consideration expected to be received, based either on the stated value in contractual arrangements or the estimated cash to be collected in non-contracted arrangements. The Company recognizes revenue as the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. The Company elected to account for shipping costs as fulfillment costs rather than a promised service and excludes from revenue any taxes collected from customers that are remitted to government authorities. The Company’s LDD contracts contain multiple performance obligations bundled for one transaction price, with all obligations generally satisfied within one year. For these bundled arrangements, the Company accounts for individual products and services as separate performance obligations if they are distinct, that is, if a product or service is separately identifiable from other items in the bundled package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company’s LDD contracts include a combination of the following performance obligations: (1) LDD capital asset and related components, (2) training and (3) device service (initial year). Each of these three performance obligations are considered distinct. The LDD capital asset is distinct because the customer can benefit from it together with other resources that are readily available to the customer. Training on the use of the machine is offered as a distinct activity after installation of the LDD to enhance the customer’s ability to utilize the machine by having an industry professional provide best practices and customize training to the specific needs of the customer. Each LDD comes with a twelve-month manufacturer’s warranty (service-type) that includes preventative maintenance, unscheduled service (labor and parts) and software updates. After the first year, service contracts can be purchased separately on a standalone basis. The Company recognizes revenue as performance obligations are satisfied by transferring control of the product or service to a customer. Specifically, revenue for the LDD capital asset is recognized at a point in time at installation. Revenue for training is also recorded at a point in time, generally 60 days after installation. Revenue for the device service is recognized ratably over time after installation, generally 12 months. The Company has determined that the transaction price is the invoice price, net of adjustments, if any. The allocation to the separate performance obligations is based upon the relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer and market conditions. The Company regularly reviews and updates standalone selling prices as necessary. LALs are held at customer sites on consignment. The single performance obligation is satisfied, and revenue from sales is recognized for LALs upon customer notification that the LALs have been implanted in a patient. For the three and six months ended June 30, 2022 and 2021, credits related to returns and rebates on list prices were not significant. The Company adopted the practical expedient permitting the direct expensing of costs incurred to obtain contracts where the amortization of such costs would occur over one year or less, and it applied to substantially all the Company’s contracts. For the three and six months ended June 30, 2022 and 2021, revenue from contracts with customers consisted of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 LDD (including training) $ 5,683 $ 2,965 $ 10,253 $ 4,802 LAL 5,349 1,792 9,453 3,321 Service warranty, service contracts, and accessories 328 140 595 258 $ 11,360 $ 4,897 $ 20,301 $ 8,381 As of June 30, 2022 and December 31, 2021, the Company recognized contract liabilities on its condensed consolidated balance sheets of $ 738,000 and $ 540,000 respectively, related to the service agreement performance obligation. Revenue for service agreements is recognized ratably over the term of each contract. The following table represents the contract liabilities from sales activity for the six months ended June 30, 2022 and 2021, respectively (in thousands): Six Months Ended June 30, 2022 2021 Balance at beginning of period $ 540 $ 345 Additions during the period 741 272 Revenue recognized during the period ( 543 ) ( 237 ) Balance at end of period $ 738 $ 380 For three and six months ended June 30, 2022 and 2021 , the Company had no customers who individually accounted for more than 10 % of revenue. For the three months ended June 30, 2021, the Company had one customer who individually accounted for approximately 13 % of revenue. For the six months ended June 30, 2021, the Company had no customer who individually accounted for 10 % or more of revenue. Stock-Based Compensation Expense The Company has three stock-based incentive compensation plans, the Calhoun Vision, Inc. 2006 Stock Plan (“2006 Plan”), the Calhoun Vision, Inc. 2015 Equity Incentive Plan (“2015 Plan”), and the 2021 Equity Incentive Plan (“2021 Plan”), which are collectively referred to as the (“Equity Plans”). The Company also has an employee stock purchase plan, the 2021 Employee Stock Purchase Plan (“2021 ESPP”). The purpose of the 2021 Plan and 2021 ESPP is to provide a means by which eligible participants may be given an opportunity to benefit from increases in the value of the common stock in order to retain or procure the services of the employees, members of the Board and consultants and provide them with an incentive to promote the Company’s success and accomplish corporate goals. Stock option awards are generally granted with an exercise price of no less than 100% of estimated fair market value on the date of grant. Time based awards generally vest over four years as follows, subject to the optionee’s continuing service: one fourth of the total number of shares vest and become exercisable on the one-year anniversary; 1/48th of the total number of shares subject to the option vest and become exercisable on each monthly anniversary thereafter for the remaining three years. Prior to the Company's shares being traded on the Nasdaq Global Market, the fair value of the Company’s common stock was determined by the Company’s Board at the time of each option grant by considering a number of objective and subjective factors. The factors included, but were not limited to: (i) third-party valuations of the Company’s common stock; (ii) the Company’s stage of development; (iii) the status of research and development efforts; (iv) the rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock; (v) the Company’s operating results and financial condition, including the Company’s levels of available capital resources; (vi) equity market conditions affecting comparable public companies; (vii) general U.S. market conditions and (viii) the lack of marketability of the Company’s common stock. After completion of the Company’s IPO in July 2021, the fair value of common stock is based on the closing price of the Company’s common stock as reported on the Nasdaq Global Market. In determining the fair value of the stock options granted, the Company uses the Black-Scholes option-pricing model and requires the use of assumptions about a number of variables as discussed below. Each of these inputs is subjective and generally requires significant judgment. Expected term —The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company used the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term. Expected volatility —Prior to the completion of the Company ’ s IPO, when the Company was privately held and did not have any trading history for its common stock, the expected volatility was estimated based on the average historical volatilities for comparable publicly traded medical device companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle and area of specialty. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-free interest rate —The risk-free interest rate used is based on the published U.S. Department of Treasury interest rates in effect at the time of stock option grant for zero coupon U.S. Treasury notes with maturities approximating each grant’s expected term. Dividend yield —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. Recent Accounting Pronouncements Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s consolidated financial statements. In June 2020, the FASB issued ASU No. 2020-06, “Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, ” ( “ ASU No. 2020-06”) which is intended to simplify the accounting for convertible instruments. This new guidance eliminates certain models that require separate accounting for embedded conversion features and eliminates certain of the conditions for equity classification for contracts in an entity’s own equity. Accordingly, a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The new guidance can be adopted through either a modified retrospective method of transition or a fully retrospective method of transition. ASU 2020-06 is effective for public business entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU 2020-06 effective January 1, 2022 using the modified retrospective method and the adoption did not have a material impact on the Company’s consolidated financial statements. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to not take this exemption and, as a result, will adopt new or revised accounting standards on the relevant effective dates on which adoption of such standards is required for other public companies that are not emerging growth companies. |
Short-Term Investment
Short-Term Investment | 6 Months Ended |
Jun. 30, 2022 | |
Short-term Investments [Abstract] | |
Short-Term Investment | Note 3 – Short-Term Investments Short-term investments consist of U.S. Treasury bills and are available-for-sale. The following tables show the Company's short-term investments as of June 30, 2022 and December 31, 2021 (in thousands): As of June 30, 2022 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 104,776 $ ( 160 ) $ 104,616 As of December 31, 2021 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 134,980 $ ( 9 ) $ 134,971 All available-for-sale securities held as of June 30, 2022 and December 31, 2021 had a maturity of less than one year . The Company has classified all marketable securities, regardless of maturity, as short-term investments based upon the Company’s ability and intent to use any and all of those marketable securities to satisfy the Company’s liquidity requirements. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 4 – Inventories Inventories consisted of the following (in thousands): June 30, December 31, 2022 2021 Finished goods $ 4,656 $ 4,451 Raw materials 4,650 2,828 Work-in-process 2,431 868 11,737 8,147 Less: reserve for excess and obsolete inventory ( 115 ) ( 115 ) $ 11,622 $ 8,032 At June 30, 2022 and December 31, 2021, finished goods included $ 2.2 million and $ 1.8 million of inventory held on consignment at customer sites, respectively. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 5 – Fair Value Measurements The table and disclosures below (in thousands) present the Company’s assets and liabilities measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value. As of June 30, 2022 Level I Level II Total Assets: Money market securities $ 22,838 $ — $ 22,838 U.S. Treasury securities — 104,616 104,616 Total assets at fair value $ 22,838 $ 104,616 $ 127,454 As of December 31, 2021 Level I Level II Total Assets: Money market securities $ 21,390 $ — $ 21,390 U.S. Treasury securities — 134,971 134,971 Total assets at fair value $ 21,390 $ 134,971 $ 156,361 The Series W warrant expired unexercised on March 31, 2021 and the remaining fair value of $ 5.0 million was recorded in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2021. The fair value of the preferred stock warrants was determined by management, with input and assistance from a third-party valuation specialist using a probability weighted expected return model/option pricing model (“PWERM/OPM”) hybrid valuation model. This method essentially utilizes a combination of market and income method approaches for each part of the calculation of enterprise value using assumptions and financial data prepared by the Company and combines them in a probabilistic manner. The valuation considered several future scenarios for the Company, each of which assumed a shareholder exit either through initial public offering, sale (“M&A”) or dissolution. Based upon the current initial public offering market, M&A values for private companies and the historical likelihood of dissolution or no exit, the Company concluded that the probabilities and time frames were reasonable. Implicit in the timing used in the application of the PWERM/OPM Hybrid Method is also the possibility of no exit. The option pricing model's significant unobservable inputs included: (1) the assumed time until a liquidity event, (2) the risk-free interest rate over the period until the assumed liquidity event, (3) the assumed volatility in the value of the equity of the company (which corresponds to the model's underlying asset volatility), (4) the enterprise value and preferred investment amount and (5) the key price points in the Company's capital structure in terms of exit levels on the assumed liquidation date. A significant increase (decrease) in any of these inputs in isolation, particularly the estimated price of the Company’s preferred stock, would have resulted in a significantly higher (lower) fair value measurement. Upon completion of the Company's IPO in July 2021 all of the 14,376,272 issued and outstanding shares of Convertible Preferred Stock outstanding were converted to common stock and 225,945 warrants to purchase Series H convertible preferred stock were exercised and converted into 100,261 shares of common stock. The following table sets forth changes in the estimated fair values for the Company’s warrant liabilities measured using significant unobservable inputs (in thousands): Six Months Ended Six Months Ended June 30, 2022 June 30, 2021 Beginning of period $ — $ 8,846 Expiration of common stock warrant — ( 5,018 ) Change in fair value of preferred stock warrants — ( 1,214 ) End of period $ — $ 2,614 |
Term Loan
Term Loan | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Term Loan | Note 6 – Term Loan In October 2020, the Company entered into a loan facility (“Term Loan”) with an initial draw of $ 25.0 million. Proceeds were used to help fund the Company’s ongoing operations. As part of the Term Loan, Oxford Finance LLC, (“Oxford Finance”) committed to providing further loans of up to $ 35.0 million to the Company at its election (or for one specific draw, upon the occurrence of a revenue milestone) during various draw periods in the future, provided the Company is not in default at the time of the additional loan draws. In March 2021, the Company drew an additional $ 5.0 million from the facility for the purpose of funding ongoing operations. In June 2021, the Company drew an additional $ 10.0 million from the facility for the purpose of funding ongoing operations. On May 3, 2022, the Company entered into a Second Amendment (“Second Amendment”) to the Term Loan (as amended through the Second Amendment, the (“Amended Term Loan”). The Amended Term Loan increased the loan and security agreement to $ 60.0 million, of which $ 40.0 million was fully funded as of May 3, 2022 from the original term loan. Under the Amended Term Loan, the Company may borrow an additional amount of up to $ 10.0 million through June 30, 2023, upon satisfaction of the applicable drawdown conditions and achieves sufficient trailing twelve-month sales as provided in the agreement for the measurement period ending March 31, 2023. Subject to the terms and conditions of the Amended Term Loan, the Company may also borrow an additional amount of up to $ 10.0 million through September 30, 2023, upon satisfaction of the applicable drawdown conditions and achieves sufficient trailing twelve-month sales as provided in the agreement for the measurement period ending June 30, 2023. The Amended Term Loan bears interest at a rate per annum equal to the greater of (i) 9.25 % or (ii) 1-Month Term Secured Overnight Financing Rate (“SOFR”) (or, if greater, 0.16%) plus an applicable margin of 9.09%. If there is an event of default under the Amended Term Loan, additional interest of 5% applies. The Amended Term Loan extends the maturity date of the loan and security agreement, which was due to expire on October 1, 2025, to February 1, 2027. The Company refers to its $ 60.0 million Amended Term Loan as its credit facility. The Amended Term Loan was recorded as a debt modification. The Amended Term Loan is secured by substantially all of the Company's personal property other than its intellectual property, but includes any accounts receivable, other amounts owed and any proceeds of intellectual property. The Company also entered into a negative pledge arrangement with the collateral agent and lenders where the Company agreed not to encumber any of its intellectual property. The Amended Term Loan also includes certain customary representations and warranties, affirmative and negative covenants, and events of default, including a financial performance-to-plan covenant that requires the Company to achieve certain minimum net sales, measured on a trailing twelve-month basis. The Amended Term Loan requires 35 months of interest-only payments, followed by 22-months of principal and accrued interest payments. If the Company is in compliance with its performance-to-plan covenant through April 1, 2025 and has not provided an IP lien election notice before May 1, 2025, the interest-only period is extended by 12 months, and the amortization period is reduced to ten months. Payments are due on the first day of each month in arrears. All unpaid amounts under the Amended Term Loan mature on February 1, 2027. The Company may elect to prepay the loans under the credit facility at any time in full or in part; however, the Company may only elect to prepay the loans in part once, in an amount not less than $ 5.0 million. Any amounts prepaid may not be subsequently reborrowed. Under the Amended Term Loan, a final payment (“Final Payment”) will be due at the earlier of the maturity date, acceleration of the loans, or a voluntary or mandatory prepayment of the loans, in an amount equal to (a) if the Final Payment is due on or after January 1, 2022 through and including October 31, 2022, three percent ( 3.00 %) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid), (b) if the Final Payment is due on or after November 1, 2022 through and including October 31, 2023, four percent ( 4.00 %) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid), and (c) if the Final Payment is due on or after November 1, 2023, five percent ( 5.00 %) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid). The Final Payment is being accreted to the carrying value of the debt as a debt premium and interest expense over the life of the loan using the effective interest method. The Company paid $ 0.1 million in loan amendment fees and other closing costs that are directly attributable to execution of the Amended Term Loan transaction. These issuance costs are recorded as a discount to the carrying amount of the debt and are being amortized, along with the unaccreted portion of the Final Payment and unamortized debt issuance costs from the original Term Loan, to interest expense over the expected term of the debt using the effective interest method. The loans may be accelerated by Oxford Finance in the event of default. As of June 30, 2022 and December 31, 2021, the Company was in compliance with all Amended Term Loan and Term Loan covenants, respectively. For the three and six months ended June 30, 2022 and 2021 the cash interest paid and effective interest rate on the Amended Term Loan and Term Loan were as follows: Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Cash interest paid 9.86 % 9.25 % 9.52 % 9.25 % Effective interest rate 11.50 % 10.90 % 11.05 % 11.09 % As of June 30, 2022 future principal payments due under the Amended Term Loan were as follows (in thousands): Year Ended December 31, 2022 (remainder) $ — 2023 — 2024 — 2025 16,364 2026 21,818 2027 1,818 Total 40,000 Less: unamortized issuance costs ( 119 ) Term loan, net $ 39,881 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | Note 7 – Stock-Based Compensation Expense The Company has three stock-based incentive compensation plans collectively referred to as the Equity Plans. The Company also has an employee stock purchase plan, the 2021 ESPP. 2006 Plan The Company’s 2006 Stock Plan was originally adopted by the Company's Board and approved by the Company’s stockholders in 2006. The Company’s 2006 Plan was terminated in 2015 in connection with the adoption of the Company’s 2015 Plan and as a result no new awards may be issued under the 2006 Plan. However, the 2006 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2006 Plan. 2015 Plan The Company’s 2015 Plan was originally adopted by the Company’s Board and approved by the Company’s stockholders in 2015. The 2015 Plan was most recently amended in March 2021. In July 2021, upon completion of the IPO, the 2015 Plan terminated immediately prior to effectiveness of the 2021 Plan with respect to the grant of future awards. However, the 2015 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2015 Plan. 2021 Plan On July 28, 2021, the Company’s 2021 Plan was adopted and approved by the Company’s Board and stockholders and became effective. The 2021 Plan provides for the grant of incentive stock options to employees and any subsidiary corporations’ employees, and for the grant of nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, or (“RSUs”), and performance awards to employees, directors, and consultants and subsidiary corporations’ employees and consultants. The number of shares of the Company’s common stock available for issuance under the 2021 Plan is equal to 2,420,135 shares of common stock plus any shares subject to awards granted under the 2015 Plan and the 2006 Plan that, after the effectiveness of the 2021 Plan, expire or otherwise terminate without having been exercised in full, are tendered to or withheld by the Company for payment of an exercise price or for tax withholding obligations, or are forfeited to or repurchased by the Company due to failure to vest, with the maximum number of shares to be added to the 2021 Plan from the 2015 Plan and 2006 Plan being equal to 4,569,530 shares of common stock. The number of common shares reserved for issuance under the 2021 Plan will be increased automatically on the first day of each fiscal year beginning with the 2022 fiscal year and ending on the ten year anniversary of the date the Board approved the 2021 Plan, by a number equal to the least of: (i) 7,260,406 shares of the Company's common stock; (ii) 4 % of the outstanding shares of common stock on the last day of the Company's immediately preceding fiscal year; or (iii) such lesser number of shares of the Company's common stock as the administrator may determine. The 2021 Plan is administered by the Company’s Board. 2021 ESPP On July 28, 2021, the Company’s Board and stockholders adopted and approved the Company’s 2021 ESPP. There are 711,643 shares of the Company’s common stock available for issuance under the 2021 ESPP. The 2021 ESPP provides eligible employees of the Company and its subsidiaries with the opportunity to purchase shares of the Company’s common stock at a purchase price equal to 85 % of the common stock’s fair market value on the first trading day or last trading day of each purchase period, whichever is lower. The 2021 ESPP provides for two six-month purchase periods every twelve months: May 1 through October 31 and November 1 through April 30. The initial purchase period began on November 1, 2021. The number of common shares reserved for issuance under the 2021 ESPP are increased automatically on the first day of each fiscal year beginning with the Company's 2022 fiscal year, by a number equal to the least of: (i) 1,452,081 shares; (ii) 1 % of the outstanding shares of common stock on the last day of the Company's immediately preceding fiscal year; or (iii) such other amount as the administrator may determine. The 2021 ESPP is administered by the Board. Registration of shares pursuant to evergreen increases On March 8, 2022, the Company filed on a Form S-8 registration statement under the Securities Act to register the offer and sale of 1,094,670 additional shares of common stock under the 2021 Plan and 273,667 shares of common stock under the 2021 ESPP. Stock Plan Activities A summary of stock option activities for the six months ended June 30, 2022 is as follows: Number of Options Weighted Weighted Avg Options outstanding as of 5,754,005 $ 11.64 5.20 Issued Granted 782,557 12.46 Exercised ( 140,826 ) 4.16 Forfeited ( 83,717 ) 14.69 Expired ( 88,909 ) 17.07 Options outstanding as of 6,223,110 11.80 6.84 Exercisable as of June 30, 2022 3,515,831 $ 10.00 5.18 A summary of non-vested restricted stock unit activities for the six months ended June 30, 2022 is as follows: Weighted Average Number of Grant Date Shares Fair Value Unvested at December 31, 2021 640,479 $ 15.46 Granted 80,427 13.37 Vested ( 104,839 ) 15.64 Forfeited ( 30,619 ) 15.38 Unvested at June 30, 2022 585,448 $ 15.14 As of June 30, 2022 and December 31, 2021 , the intrinsic value of options vested was $ 19.1 million and $ 14.7 million, respectively, and of all options outstanding was $ 21.3 million and $ 14.7 million, respectively. During the six months ended June 30, 2022 and 2021 , the total cash received from the exercise of stock options was $ 0.6 million and $ 1.2 million, respectively. The total fair value less strike price of these options was $ 1.2 million and $ 3.1 million, respectively. Stock-based compensation expense was classified in the accompanying condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 792 $ 540 $ 1,566 $ 1,137 Selling, general and administrative 1,866 686 3,520 1,149 Cost of goods sold 246 180 467 359 $ 2,904 $ 1,406 $ 5,553 $ 2,645 As of June 30, 2022 and December 31, 2021 , there were 2,707,279 and 2,437,649 unvested options, respectively. Total unrecognized expense related to unvested stock options was approximately $ 21.0 million and $ 20.1 million as of June 30, 2022 and December 31, 2021 , respectively. Amounts are expected to be recognized over a weighted average period of approximately 2.9 and 3.0 years, respectively. As of June 30, 2022 , there was $ 8.0 million of total unrecognized compensation costs, adjusted for any forfeitures, related to non-vested restricted stock units granted under the 2021 Plan. The unrecognized compensation cost is expected to be recognized over a weighted average period of 2.9 years. The following table presents the range and weighted-average assumptions, used in the Black-Scholes option pricing model to determine the fair value of stock options: Six Months Ended June 30, 2022 2021 Range Weighted Average Range Weighted Average Expected volatility 62.4 % to 63.4 % 62.7 % 62.3 % to 63.7 % 63.6 % Risk-free interest rate 2.0 % to 3.0 % 2.2 % 0.6 % to 1.6 % 1.1 % Expected life (in years) 6.0 to 10.0 years 6.1 years 5.52 to 10.00 years 6 year s Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Grant date fair value $ 10.74 to $ 12.85 $ 12.32 $ 15.60 to $ 19.94 $ 15.64 Common Stock Each share of common stock is entitled to one vote. Common stock reserved for future issuance consisted of the following: June 30, 2022 December 31, 2021 Stock options issued and outstanding under the Equity Plans 6,223,110 5,754,005 Restricted stock units 585,448 640,479 Employee stock purchase plan 711,643 484,027 Total shares of common stock reserved 7,520,201 6,878,511 On January 3, 2022, the Board approved the issuance of 19,196 restricted stock units to a non-employee director. The award will vest over three years of service. On June 2, 2022, the Company issued automatic annual awards of 61,231 restricted stock units to seven non-employee directors related to their continued service on the Board. The awards will vest over one year of service. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Note 8 – Leases The Company has operating and finance leases for facilities and certain equipment. Leases with an initial term of 12 months or less are not recorded on the condensed consolidated balance sheets. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company does not combine lease and non-lease components in the recognition of lease expense. As of June 30, 2022 the Company held four leases for office, manufacturing and warehouse facilities in Aliso Viejo, California. The four leases are for approximately 121,000 square feet in the aggregate and expire between August 31, 2024 and January 31, 2026 . For one of the facilities operating leases, the lessor provided $ 900,000 in tenant allowances. On April 4, 2022, the Company entered into a thirty-four-month sublease agreement for a portion of the 5 Columbia Building, in Aliso Viejo, CA. The sublease commencement date was June 13, 2022 and will expire on March 31, 2025 . The base rent receivable is $ 11,410 per month. The following table presents the lease balances within the condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021 (in thousands): June 30, December 31, Leases Classification 2022 2021 Assets Operating Operating leases right-of-use assets 4,704 $ 4,284 Finance Property and equipment, net 265 $ 33 Total lease assets 4,969 4,317 Liabilities Current Operating Lease liabilities 1,716 1,509 Finance Lease liabilities 126 20 Noncurrent Operating Long-term lease liabilities 3,744 3,625 Finance Long-term lease liabilities 107 17 Total lease liabilities $ 5,693 $ 5,171 For the three and six months ended June 30, 2022 and 2021, the components of operating and finance lease expenses were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Lease Cost Classification 2022 2021 2022 2021 Operating lease cost Cost of sales $ 3 $ 3 $ 7 $ 7 Research and development 85 79 159 158 Selling, general and administrative 429 402 833 803 Finance lease cost Research and development 32 — 46 — Selling, general and administrative 4 7 9 14 Finance lease cost Interest expense 4 1 7 3 Maturities of the Company’s operating and finance lease liabilities as of June 30, 2022 were as follows (in thousands): Operating Finance Year Ended December 31, Leases Leases 2022 (remainder) $ 1,024 $ 65 2023 2,058 149 2024 1,788 36 2025 1,002 6 2026 80 — 2027 — — Total lease payments 5,952 256 Less: imputed interest ( 492 ) ( 23 ) Total lease liabilities $ 5,460 $ 233 The weighted average remaining lease term and weighted average discount rate used to determine lease liabilities related to the Company’s operating and finance leases as of June 30, 2022 and December 31, 2021 were: June 30, December 31, Lease Term and Discount Rate 2022 2021 Weighted average remaining lease term (years) Operating leases 2.87 3.30 Finance leases 1.78 1.72 Weighted average discount rate Operating leases 10.3 % 10.5 % Finance leases 9.5 % 10.5 % |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies Letter of credit The Company has a standby letter of credit, expiring September 30, 2024, issued by a financial institution as required security for one operating lease. The aggregate amount of the letter of credit was $ 310,000 as of June 30, 2022 and December 31, 2021. Legal Matters From time-to-time, the Company may be involved in certain legal proceedings or regulatory matters arising in the ordinary course of business, including without limitation, actions with respect to intellectual property, employment, regulatory, product liability and contractual matters. In connection with these proceedings or matters, the Company regularly assesses the probability and amount (or range) of possible issues based on the developments in these proceedings or matters. A liability is recorded in the consolidated financial statements if it is determined that it is probable that a loss has been incurred, and that the amount (or range) of the loss can be reasonably estimated. Because of the uncertainties related to any pending proceedings or matters, the Company is currently unable to predict their ultimate outcome and, with respect to any legal proceeding or regulatory matter where no liability has been accrued, to make a reasonable estimate of the possible loss (or range of loss) that could result from an adverse outcome. At June 30, 2022 and December 31, 2021 , there were no legal proceedings, regulatory matters, or other disputes or claims for which a material loss was considered probable or for which the amount (or range) of loss was reasonably estimable. However, regardless of the outcome, legal proceedings, regulatory matters, and other disputes and claims can have an adverse impact on the Company because of legal costs, diversion of management time and resources, and other factors. |
Summary of Accounting Policies
Summary of Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The December 31, 2021 balance sheet data was derived from audited financial statements; however, the accompanying notes to the condensed consolidated financial statements do not include all of the annual disclosures required under GAAP and should be read in conjunction with the Company’s 2021 Annual Report on Form 10-K filed with the SEC on March 8, 2022. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. |
Initial Public Offering and Reverse Stock Split | Initial Public Offering ( “ IPO ” ) and Reverse Stock Split On July 22, 2021, the Company’s Board of Directors (“Board”) approved an amendment to the Company’s certificate of incorporation to effect a reverse split of shares of the Company’s common stock, excluding Series G and Series W common stock, and convertible preferred stock on a 1-for-10.33 basis (“Reverse Stock Split”). The par values of the common stock and convertible preferred stock were not adjusted as a result of the Reverse Stock Split. The Reverse Stock Split was effected on July 23, 2021. Accordingly, all common stock, excluding Series G and Series W common stock, options to purchase common stock, convertible preferred stock, share data, per share data and related information contained in the accompanying condensed consolidated financial statements and notes have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented. Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The Reverse Stock Split resulted in an adjustment to the convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. On July 29, 2021 , the Company completed its IPO which resulted in the issuance and sale of 8,248,549 shares of its common stock at a price of $ 16.00 per share. The aggregate net proceeds from the offering, which included 898,549 common shares sold upon the partial exercise of the underwriters’ over-allotment option, after deducting underwriting discounts and commissions of $ 9.2 million and other offering costs of $ 3.2 million, were approximately $ 119.6 million. On July 29, 2021, the Company amended and restated its certificate of incorporation and bylaws which provide for, among other things, the Company’s authorized capital stock to consist of 900,000,000 shares of common stock, par value $ 0.001 per share, and 100,000,000 shares of convertible preferred stock, par value $ 0.001 per share. The amended and restated certificate of incorporation defines the voting rights, dividends, liquidation rights and preferences of each class of stock. Immediately prior to the completion of the IPO, (i) 14,376,272 outstanding shares of the Company's convertible preferred stock were converted into an aggregate of 14,725,309 shares of common stock and (ii) 225,945 warrants to purchase Series H convertible preferred stock were exercised and converted into 100,261 shares of common stock. |
Liquidity and Financial Position | Liquidity and Financial Position As of June 30, 2022 and December 31, 2021 the Company had cash, cash equivalents and short-term investments of $ 128.6 million and $ 159.3 million, respectively. The Company began generating revenue from its principal operations in 2019. The Company has a limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. For the three months ended June 30, 2022 and 2021 the Company incurred losses from operations of $ 15.8 million and $ 13.9 million, respectively. For the six months ended June 30, 2022 and 2021, the Company incurred losses from operations of $ 32.4 million and $ 25.0 million, respectively. Due to the Company’s continuing research and development activities and expansion of its sales and marketing activities, the Company expects to continue to incur net operating losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon gaining market acceptance of the Company’s products and achieving a level of revenues adequate to support the Company’s cost structure. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company believes that existing cash resources will be sufficient to meet projected operating requirements for at least 12 months from the date of issuance of the accompanying condensed consolidated financial statements, though the Company expects to continue to incur operating losses and negative cash flows. The Company plans to continue to fund its losses from operations using its cash, cash equivalents and short-term investments as of June 30, 2022 and meet its future capital funding needs through equity or debt financings, other third-party funding, collaborations, strategic alliances and licensing arrangements or a combination of these. If the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. Any future debt financing into which the Company enters may impose additional covenants that restrict operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity raise may contain terms that are not favorable to the Company or its stockholders. If the Company is required to enter into collaborations and other arrangements to address its liquidity needs, it may have to give up certain rights that limit its ability to develop and commercialize product candidates or may have other terms that are not favorable to the Company or its stockholders, which could materially and adversely affect its business and financial prospects. There can be no assurance that the Company will be able to obtain additional financing on acceptable terms, or at all. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make informed estimates, judgments and assumptions that affect the reported amounts in the condensed consolidated financial statements and disclosures in the accompanying notes as of the date of the accompanying condensed consolidated financial statements. On an on-going basis, management evaluates the most critical estimates and assumptions for continued reasonableness. Actual results may differ materially from the estimates used in the preparation of the accompanying condensed consolidated financial statements under different assumptions or conditions. |
Significant Accounting Policies | Significant Accounting Policies There have been no significant changes to the accounting policies during the six months ended June 30, 2022 , as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K filed with the SEC on March 8, 2022. |
Cash Equivalents | Cash Equivalents Cash equivalents consist of investments in money market accounts. The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase that can be liquidated without prior notice or penalty to be cash equivalents. |
Short-term Investments | Short-term Investments Short-term investments are classified based on the maturity date of the related securities. Based on the nature of the assets, the Company’s short-term investments, which are government securities, are classified as available-for-sale and are recorded at their estimated fair value as determined by prices for identical or similar securities at the balance sheet date. The Company’s short-term investments consist of Level 2 financial instruments in the fair value hierarchy. Unrealized gains and losses are recorded as a component of Other Comprehensive Loss within Stockholders’ Equity on the condensed consolidated balance sheets. Realized gains and losses are included as other income (expense) in the accompanying condensed consolidated statements of operations and comprehensive loss. The cost basis for realized gains and losses on available-for-sale securities is determined on a specific identification basis. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such determination at each balance sheet date. The Company periodically reviews its investments for unrealized losses other than credit losses and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. In determining whether the carrying value is recoverable, management considers the following factors: • whether the investment has been in a continuous loss position for over 12 months; • the duration to maturity of investments; • intention and ability to hold the investment to maturity and if it is not more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. The Company had $ 160,000 and $ 9,000 of unrealized losses related to short-term investments as of June 30, 2022 and December 31, 2021 , respectively. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments which potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company’s policy is to invest cash in institutional money market funds and marketable securities of the U.S. government to limit the amount of credit exposure. The Company currently maintains a portfolio of cash equivalents and short-term investments in money market funds and U.S. treasury bills. Additionally, the Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. The Company has not experienced material losses on cash equivalents and short-term investments. The Company’s products require approval from the FDA and foreign regulatory agencies before commercial sales can commence. There can be no assurance that the Company’s products will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on the Company’s business and may impact business in the future. In addition, after approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the device approval process. The Company is subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of the Company's products, product liability and the need to obtain additional financing. The Company is subject to the risks related to the global pandemic associated with COVID-19, including local, state, federal and other world-wide mandates imposed to reduce the spread of the virus which could interrupt or reduce the number of cataract surgeries, limit access to ambulatory surgery centers, doctors’ offices and manufacturing facilities, and the expansion of global lead times, particularly in Europe and Asia, leading to a supply interruption from the Company's suppliers. In addition, the Company is currently experiencing inflation and longer lead times and limited availability in its supply chain for certain components and has continued exposure to price and supply risk related to anticipated purchases of certain commodities, materials and products used in its business. |
Accounts Receivable | Accounts Receivable The Company has a diverse customer base and as of June 30, 2022 and December 31, 2021 the Company had no customers who individually accounted for more than 10 % of accounts receivable. The Company maintains an allowance for credit losses resulting from the inability of its customers, including ambulatory surgery centers, to make required payments. After evaluation of the collectability of accounts receivable, the Company did no t record any significant allowance for credit losses as of June 30, 2022 or December 31, 2021 . |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company’s financial instruments consist principally of cash, cash equivalents, short-term investments, accounts receivable, accounts payable, operating lease liabilities and a term loan. Fair value is measured as the price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques that are consistent with the market, income or cost approach are used to measure fair value. The fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels: Level 1—Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities. Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability, for substantially the full term of the asset or liability, through correlation with market data. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and inputs to valuation models or other pricing methodologies that do not require significant judgment because the inputs used in the model, such as interest rates and volatility, can be corroborated by readily observable market data. Level 3—One or more significant inputs that are unobservable and supported by little or no market activity and reflect the use of significant management judgment and assumptions. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. These include the Black-Scholes option-pricing model which uses inputs such as expected volatility, risk-free interest rate and expected term to determine fair market valuation. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented. |
Inventories | Inventories Inventories consist of raw materials, work-in-process and finished goods. Raw materials are comprised of chemicals and parts used in the production of the Company's lenses, cartridges, and LDDs. Finished goods are comprised of lenses, cartridges, accessories and LDDs. Inventories are valued at the lower of cost or net realizable value. Cost is computed using standard cost, which approximates actual cost on a first-in, first-out basis. The carrying value of inventories is reviewed for potential impairment whenever indicators suggest that the cost of inventories exceeds the carrying value and management adjusts the inventories to its net realizable value. The cost of finished goods and work-in-process is comprised of raw materials, direct labor, other direct costs and related production overhead to the extent that these costs do not exceed the net realizable value of the goods produced. The Company periodically reviews inventories for potential impairment, estimated losses from obsolescence, material expirations or unmarketable inventories or excess inventories and writes down the cost of inventories to net realizable value at the time such determinations are made. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose. |
Leases | Leases Lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized when the Company takes possession of the leased property (“Commencement Date”) based on the present value of lease payments over the lease term. The Company estimates the incremental borrowing rate based upon the cost of its own debt financing, current market interest rates and quoted offerings or the rate implicit in the lease. Operating lease right-of-use assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The lease terms used to calculate the right-of-use asset and related lease liability include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Rent expense on noncancelable leases containing known future scheduled rent increases is recorded on a straight-line basis over the term of the respective leases beginning on the Commencement Date. The difference between rent expense and rent paid is accounted for as a component of operating lease right-of-use assets on the accompanying condensed consolidated balance sheets. Landlord improvement allowances and other such lease incentives are recorded as property and equipment and as reduction of the right-of-use leased assets and are amortized on a straight-line basis as a reduction to operating lease costs. Leases with an initial term of 12 months or less are expensed as incurred and are not recorded as right-of-use assets on the condensed consolidated balance sheets. |
Net Loss per Share | Net Loss per Share The Company computes basic net loss per share for common stock using the two-class method required for companies with participating securities based upon the weighted-average number of common shares outstanding during the period. Diluted net loss per share assumes the conversion, exercise or issuance of all potential common stock equivalents, unless the effect of inclusion would be anti-dilutive. For purposes of this calculation, common stock equivalents include the Company’s stock options, warrants and the shares issuable upon the conversion of the preferred stock. For stock options and preferred stock, the calculation of diluted loss per share requires an adjustment for the additional share of undistributed earnings. For warrants that are recorded as a liability in the condensed consolidated balance sheets, the calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to the loss per share for the period, an adjustment is made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. The following tables show the computation of basic and diluted net loss per share for the three and six months ended June 30, 2022 and 2021 (amounts in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Common Stock Numerator: Net loss attributable to stockholders, basic $ ( 16,732 ) $ ( 13,477 ) $ ( 34,328 ) $ ( 20,282 ) Effect of dilutive securities: Preferred stock warrants — 1,214 — 1,214 Net loss available to stockholders, $ ( 16,732 ) $ ( 14,691 ) $ ( 34,328 ) $ ( 21,496 ) Denominator: Weighted-average shares outstanding, basic 27,559,908 4,106,403 27,493,130 4,052,920 Effect of dilutive securities: Preferred stock warrants — 60,036 — 60,329 Weighted-average shares, diluted 27,559,908 4,166,439 27,493,130 4,113,249 Basic net loss per share $ ( 0.61 ) $ ( 3.28 ) $ ( 1.25 ) $ ( 5.00 ) Diluted net loss per share $ ( 0.61 ) $ ( 3.53 ) $ ( 1.25 ) $ ( 5.23 ) Series G Common Stock Numerator: Net loss available to stockholder, basic $ — $ ( 0.32 ) $ — $ ( 0.48 ) Effect of dilutive securities: Preferred stock warrants — — — — Net loss attributable to stockholder, diluted $ — $ ( 0.32 ) $ — $ ( 0.48 ) Denominator: Weighted-average shares outstanding, basic and diluted 1 1 Basic net loss per share — $ ( 0.32 ) — $ ( 0.48 ) Diluted net loss per share — $ ( 0.32 ) — $ ( 0.48 ) The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders because their impact under the “treasury stock method” and “if-converted method” was anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Convertible preferred stock — 14,850,993 — 14,850,993 Stock options issued and outstanding under the Calhoun Vision, Inc. 2006 Stock Plan, Calhoun Vision, Inc. 2015 Equity Incentive Plan and the 2021 Equity Incentive Plan 1,942,092 4,610,950 1,973,913 4,368,665 Restricted stock units 65,825 — 48,188 — Stock issuable in offering period under the Employee Stock Purchase Plan 48,373 — 47,496 — |
Revenue Recognition | Revenue Recognition The Company’s revenue is generated from the sale of LALs used in cataract surgery along with a specifically designed machine for delivering light to the eye, the LDD, to adjust the lens post-surgery, as needed. Revenue is recognized from sales of products in the U.S. and Europe. Customers are primarily comprised of ambulatory surgery centers, hospitals, and physician private practices. The Company recognizes revenues when promised goods or services are transferred to customers at a transaction price that reflects the consideration to which the Company expects to be entitled in exchange for those goods and services. Specifically, the Company applies the following five steps to recognize revenue: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies a performance obligation. The Company applies the five-step model to contracts when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods promised within each customer contract to determine the individual deliverables in its product offerings as separate performance obligations and assesses whether each promised good or service is distinct. The transaction price is determined based on the consideration expected to be received, based either on the stated value in contractual arrangements or the estimated cash to be collected in non-contracted arrangements. The Company recognizes revenue as the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. The Company elected to account for shipping costs as fulfillment costs rather than a promised service and excludes from revenue any taxes collected from customers that are remitted to government authorities. The Company’s LDD contracts contain multiple performance obligations bundled for one transaction price, with all obligations generally satisfied within one year. For these bundled arrangements, the Company accounts for individual products and services as separate performance obligations if they are distinct, that is, if a product or service is separately identifiable from other items in the bundled package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company’s LDD contracts include a combination of the following performance obligations: (1) LDD capital asset and related components, (2) training and (3) device service (initial year). Each of these three performance obligations are considered distinct. The LDD capital asset is distinct because the customer can benefit from it together with other resources that are readily available to the customer. Training on the use of the machine is offered as a distinct activity after installation of the LDD to enhance the customer’s ability to utilize the machine by having an industry professional provide best practices and customize training to the specific needs of the customer. Each LDD comes with a twelve-month manufacturer’s warranty (service-type) that includes preventative maintenance, unscheduled service (labor and parts) and software updates. After the first year, service contracts can be purchased separately on a standalone basis. The Company recognizes revenue as performance obligations are satisfied by transferring control of the product or service to a customer. Specifically, revenue for the LDD capital asset is recognized at a point in time at installation. Revenue for training is also recorded at a point in time, generally 60 days after installation. Revenue for the device service is recognized ratably over time after installation, generally 12 months. The Company has determined that the transaction price is the invoice price, net of adjustments, if any. The allocation to the separate performance obligations is based upon the relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer and market conditions. The Company regularly reviews and updates standalone selling prices as necessary. LALs are held at customer sites on consignment. The single performance obligation is satisfied, and revenue from sales is recognized for LALs upon customer notification that the LALs have been implanted in a patient. For the three and six months ended June 30, 2022 and 2021, credits related to returns and rebates on list prices were not significant. The Company adopted the practical expedient permitting the direct expensing of costs incurred to obtain contracts where the amortization of such costs would occur over one year or less, and it applied to substantially all the Company’s contracts. For the three and six months ended June 30, 2022 and 2021, revenue from contracts with customers consisted of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 LDD (including training) $ 5,683 $ 2,965 $ 10,253 $ 4,802 LAL 5,349 1,792 9,453 3,321 Service warranty, service contracts, and accessories 328 140 595 258 $ 11,360 $ 4,897 $ 20,301 $ 8,381 As of June 30, 2022 and December 31, 2021, the Company recognized contract liabilities on its condensed consolidated balance sheets of $ 738,000 and $ 540,000 respectively, related to the service agreement performance obligation. Revenue for service agreements is recognized ratably over the term of each contract. The following table represents the contract liabilities from sales activity for the six months ended June 30, 2022 and 2021, respectively (in thousands): Six Months Ended June 30, 2022 2021 Balance at beginning of period $ 540 $ 345 Additions during the period 741 272 Revenue recognized during the period ( 543 ) ( 237 ) Balance at end of period $ 738 $ 380 For three and six months ended June 30, 2022 and 2021 , the Company had no customers who individually accounted for more than 10 % of revenue. For the three months ended June 30, 2021, the Company had one customer who individually accounted for approximately 13 % of revenue. For the six months ended June 30, 2021, the Company had no customer who individually accounted for 10 % or more of revenue. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company has three stock-based incentive compensation plans, the Calhoun Vision, Inc. 2006 Stock Plan (“2006 Plan”), the Calhoun Vision, Inc. 2015 Equity Incentive Plan (“2015 Plan”), and the 2021 Equity Incentive Plan (“2021 Plan”), which are collectively referred to as the (“Equity Plans”). The Company also has an employee stock purchase plan, the 2021 Employee Stock Purchase Plan (“2021 ESPP”). The purpose of the 2021 Plan and 2021 ESPP is to provide a means by which eligible participants may be given an opportunity to benefit from increases in the value of the common stock in order to retain or procure the services of the employees, members of the Board and consultants and provide them with an incentive to promote the Company’s success and accomplish corporate goals. Stock option awards are generally granted with an exercise price of no less than 100% of estimated fair market value on the date of grant. Time based awards generally vest over four years as follows, subject to the optionee’s continuing service: one fourth of the total number of shares vest and become exercisable on the one-year anniversary; 1/48th of the total number of shares subject to the option vest and become exercisable on each monthly anniversary thereafter for the remaining three years. Prior to the Company's shares being traded on the Nasdaq Global Market, the fair value of the Company’s common stock was determined by the Company’s Board at the time of each option grant by considering a number of objective and subjective factors. The factors included, but were not limited to: (i) third-party valuations of the Company’s common stock; (ii) the Company’s stage of development; (iii) the status of research and development efforts; (iv) the rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock; (v) the Company’s operating results and financial condition, including the Company’s levels of available capital resources; (vi) equity market conditions affecting comparable public companies; (vii) general U.S. market conditions and (viii) the lack of marketability of the Company’s common stock. After completion of the Company’s IPO in July 2021, the fair value of common stock is based on the closing price of the Company’s common stock as reported on the Nasdaq Global Market. In determining the fair value of the stock options granted, the Company uses the Black-Scholes option-pricing model and requires the use of assumptions about a number of variables as discussed below. Each of these inputs is subjective and generally requires significant judgment. Expected term —The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company used the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term. Expected volatility —Prior to the completion of the Company ’ s IPO, when the Company was privately held and did not have any trading history for its common stock, the expected volatility was estimated based on the average historical volatilities for comparable publicly traded medical device companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle and area of specialty. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-free interest rate —The risk-free interest rate used is based on the published U.S. Department of Treasury interest rates in effect at the time of stock option grant for zero coupon U.S. Treasury notes with maturities approximating each grant’s expected term. Dividend yield —The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s consolidated financial statements. In June 2020, the FASB issued ASU No. 2020-06, “Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, ” ( “ ASU No. 2020-06”) which is intended to simplify the accounting for convertible instruments. This new guidance eliminates certain models that require separate accounting for embedded conversion features and eliminates certain of the conditions for equity classification for contracts in an entity’s own equity. Accordingly, a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The new guidance can be adopted through either a modified retrospective method of transition or a fully retrospective method of transition. ASU 2020-06 is effective for public business entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU 2020-06 effective January 1, 2022 using the modified retrospective method and the adoption did not have a material impact on the Company’s consolidated financial statements. |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to not take this exemption and, as a result, will adopt new or revised accounting standards on the relevant effective dates on which adoption of such standards is required for other public companies that are not emerging growth companies. |
Short-Term Investment (Tables)
Short-Term Investment (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Short-term Investments [Abstract] | |
Schedule of Short-term Investments Available For Sale | Short-term investments consist of U.S. Treasury bills and are available-for-sale. The following tables show the Company's short-term investments as of June 30, 2022 and December 31, 2021 (in thousands): As of June 30, 2022 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 104,776 $ ( 160 ) $ 104,616 As of December 31, 2021 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 134,980 $ ( 9 ) $ 134,971 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following (in thousands): June 30, December 31, 2022 2021 Finished goods $ 4,656 $ 4,451 Raw materials 4,650 2,828 Work-in-process 2,431 868 11,737 8,147 Less: reserve for excess and obsolete inventory ( 115 ) ( 115 ) $ 11,622 $ 8,032 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on recurring basis and the fair value hierarchy of the valuation techniques | The table and disclosures below (in thousands) present the Company’s assets and liabilities measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value. As of June 30, 2022 Level I Level II Total Assets: Money market securities $ 22,838 $ — $ 22,838 U.S. Treasury securities — 104,616 104,616 Total assets at fair value $ 22,838 $ 104,616 $ 127,454 As of December 31, 2021 Level I Level II Total Assets: Money market securities $ 21,390 $ — $ 21,390 U.S. Treasury securities — 134,971 134,971 Total assets at fair value $ 21,390 $ 134,971 $ 156,361 |
Schedule of estimated fair value for the warrant liabilities measured using significant unobservable inputs | The following table sets forth changes in the estimated fair values for the Company’s warrant liabilities measured using significant unobservable inputs (in thousands): Six Months Ended Six Months Ended June 30, 2022 June 30, 2021 Beginning of period $ — $ 8,846 Expiration of common stock warrant — ( 5,018 ) Change in fair value of preferred stock warrants — ( 1,214 ) End of period $ — $ 2,614 |
Term Loan (Tables)
Term Loan (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Future Principal Payments Due Under the Term Loan | As of June 30, 2022 future principal payments due under the Amended Term Loan were as follows (in thousands): Year Ended December 31, 2022 (remainder) $ — 2023 — 2024 — 2025 16,364 2026 21,818 2027 1,818 Total 40,000 Less: unamortized issuance costs ( 119 ) Term loan, net $ 39,881 |
Schedule of Cash Interest Paid and Effective Interest Rate On Term Loan | For the three and six months ended June 30, 2022 and 2021 the cash interest paid and effective interest rate on the Amended Term Loan and Term Loan were as follows: Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Cash interest paid 9.86 % 9.25 % 9.52 % 9.25 % Effective interest rate 11.50 % 10.90 % 11.05 % 11.09 % |
Stock-Based Compensation Expe_2
Stock-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activities | A summary of stock option activities for the six months ended June 30, 2022 is as follows: Number of Options Weighted Weighted Avg Options outstanding as of 5,754,005 $ 11.64 5.20 Issued Granted 782,557 12.46 Exercised ( 140,826 ) 4.16 Forfeited ( 83,717 ) 14.69 Expired ( 88,909 ) 17.07 Options outstanding as of 6,223,110 11.80 6.84 Exercisable as of June 30, 2022 3,515,831 $ 10.00 5.18 |
Summary of Non-Vested Restricted stock unit Activities | A summary of non-vested restricted stock unit activities for the six months ended June 30, 2022 is as follows: Weighted Average Number of Grant Date Shares Fair Value Unvested at December 31, 2021 640,479 $ 15.46 Granted 80,427 13.37 Vested ( 104,839 ) 15.64 Forfeited ( 30,619 ) 15.38 Unvested at June 30, 2022 585,448 $ 15.14 |
Schedule of Stock-Based Compensation Expense | Stock-based compensation expense was classified in the accompanying condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 792 $ 540 $ 1,566 $ 1,137 Selling, general and administrative 1,866 686 3,520 1,149 Cost of goods sold 246 180 467 359 $ 2,904 $ 1,406 $ 5,553 $ 2,645 |
Schedule of Range and Weighted-average Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options | The following table presents the range and weighted-average assumptions, used in the Black-Scholes option pricing model to determine the fair value of stock options: Six Months Ended June 30, 2022 2021 Range Weighted Average Range Weighted Average Expected volatility 62.4 % to 63.4 % 62.7 % 62.3 % to 63.7 % 63.6 % Risk-free interest rate 2.0 % to 3.0 % 2.2 % 0.6 % to 1.6 % 1.1 % Expected life (in years) 6.0 to 10.0 years 6.1 years 5.52 to 10.00 years 6 year s Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Grant date fair value $ 10.74 to $ 12.85 $ 12.32 $ 15.60 to $ 19.94 $ 15.64 |
Schedule of Common stock reserved for future issuance | Each share of common stock is entitled to one vote. Common stock reserved for future issuance consisted of the following: June 30, 2022 December 31, 2021 Stock options issued and outstanding under the Equity Plans 6,223,110 5,754,005 Restricted stock units 585,448 640,479 Employee stock purchase plan 711,643 484,027 Total shares of common stock reserved 7,520,201 6,878,511 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Schedule of Lease Balance Sheet Information | The following table presents the lease balances within the condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021 (in thousands): June 30, December 31, Leases Classification 2022 2021 Assets Operating Operating leases right-of-use assets 4,704 $ 4,284 Finance Property and equipment, net 265 $ 33 Total lease assets 4,969 4,317 Liabilities Current Operating Lease liabilities 1,716 1,509 Finance Lease liabilities 126 20 Noncurrent Operating Long-term lease liabilities 3,744 3,625 Finance Long-term lease liabilities 107 17 Total lease liabilities $ 5,693 $ 5,171 |
Schedule of Component of Lease Expense | For the three and six months ended June 30, 2022 and 2021, the components of operating and finance lease expenses were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, Lease Cost Classification 2022 2021 2022 2021 Operating lease cost Cost of sales $ 3 $ 3 $ 7 $ 7 Research and development 85 79 159 158 Selling, general and administrative 429 402 833 803 Finance lease cost Research and development 32 — 46 — Selling, general and administrative 4 7 9 14 Finance lease cost Interest expense 4 1 7 3 |
Schedule of Maturities of Lease Liabilities | Maturities of the Company’s operating and finance lease liabilities as of June 30, 2022 were as follows (in thousands): Operating Finance Year Ended December 31, Leases Leases 2022 (remainder) $ 1,024 $ 65 2023 2,058 149 2024 1,788 36 2025 1,002 6 2026 80 — 2027 — — Total lease payments 5,952 256 Less: imputed interest ( 492 ) ( 23 ) Total lease liabilities $ 5,460 $ 233 |
Summary of Weighted Average Remaining Lease Term and Discount Rate | The weighted average remaining lease term and weighted average discount rate used to determine lease liabilities related to the Company’s operating and finance leases as of June 30, 2022 and December 31, 2021 were: June 30, December 31, Lease Term and Discount Rate 2022 2021 Weighted average remaining lease term (years) Operating leases 2.87 3.30 Finance leases 1.78 1.72 Weighted average discount rate Operating leases 10.3 % 10.5 % Finance leases 9.5 % 10.5 % |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Millions | 3 Months Ended | 6 Months Ended | ||||||
Jul. 29, 2021 USD ($) $ / shares shares | Jul. 22, 2021 | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) Subsidiary $ / shares shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) $ / shares shares | Jul. 31, 2021 shares | |
Subsequent Event [Line Items] | ||||||||
Number of wholly owned subsidiaries | Subsidiary | 1 | |||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||
Aggregate shares of common stock | 14,725,309 | 14,725,309 | ||||||
Reverse stock split | 1-for-10.33 | |||||||
Cash, cash equivalents, and short-term investments | $ | $ 128.6 | $ 128.6 | $ 159.3 | |||||
Losses from operations | $ | $ 15.8 | $ 13.9 | $ 32.4 | $ 25 | ||||
Common stock, shares authorized | 900,000,000 | 900,000,000 | 900,000,000 | 900,000,000 | ||||
Common stock par value per share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Preferred stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 | |||||
Preferred stock par value per share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Convertible Preferred Stock | ||||||||
Subsequent Event [Line Items] | ||||||||
Preferred stock, shares outstanding | 14,376,272 | 14,376,272 | ||||||
Preferred stock, shares authorized | 100,000,000 | |||||||
Preferred stock par value per share | $ / shares | $ 0.001 | |||||||
Series H Convertible Preferred Stock | ||||||||
Subsequent Event [Line Items] | ||||||||
Aggregate shares of common stock | 100,261 | |||||||
Warrants exercised | 225,945 | 225,945 | ||||||
Number of converted shares of common stock | 100,261 | 100,261 | ||||||
IPO [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Sale of shares | 8,248,549 | |||||||
Sale of stock, date | Jul. 29, 2021 | |||||||
Common stock par or stated value per share | $ / shares | $ 16 | |||||||
Additional common shares sold | 898,549 | |||||||
Aggregate net proceeds from offering | $ | $ 119.6 | |||||||
Aggregate shares of common stock | 14,376,272 | |||||||
Common stock sale underwriting discounts and commission deducted | $ | 9.2 | |||||||
Common Stock Offering Costs | $ | $ 3.2 |
Summary of Accounting Policie_2
Summary of Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Unrealized gain (Loss) on short term investments | $ 160,000 | $ 9,000 | ||
Accounts receivable, percentage | 10% | 10% | ||
Allowance for doubtful accounts | $ 0 | $ 0 | ||
Deferred revenue | $ 738,000 | $ 540,000 | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | No Customer [Member] | ||||
Concentration Risk, Percentage | 10% | 10% | ||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | One Customer [Member] | ||||
Concentration Risk, Percentage | 13% |
Summary of Accounting Policie_3
Summary of Accounting Policies - Schedule of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Denominator: | ||||
Weighted-average shares outstanding, basic | 27,559,908 | 4,106,403 | 27,493,130 | 4,052,920 |
Weighted-average shares, diluted | 27,559,908 | 4,166,439 | 27,493,130 | 4,113,249 |
Basic net income (loss) per share | $ (0.61) | $ (3.28) | $ (1.25) | $ (5) |
Diluted net income (loss) per share | $ (0.61) | $ (3.53) | $ (1.25) | $ (5.23) |
Preferred Stock Warrants | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities | ||||
Common Stock | ||||
Numerator: | ||||
Net (loss) income available to common stockholders | (16,732,000) | $ (13,477,000) | (34,328,000) | $ (20,282,000) |
Effect of dilutive securities: | ||||
Net (loss) income available to stockholders, diluted | $ (16,732,000) | $ (14,691,000) | $ (34,328,000) | $ (21,496,000) |
Denominator: | ||||
Weighted-average shares outstanding, basic | 27,559,908 | 4,106,403 | 27,493,130 | 4,052,920 |
Weighted-average shares, diluted | 27,559,908 | 4,166,439 | 27,493,130 | 4,113,249 |
Basic net income (loss) per share | $ (0.61) | $ (3.28) | $ (1.25) | $ (5) |
Diluted net income (loss) per share | $ (0.61) | $ (3.53) | $ (1.25) | $ (5.23) |
Common Stock | Preferred Stock Warrants | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities | $ 1,214,000 | $ 1,214,000 | ||
Denominator: | ||||
Effect of Anti Dilutive Securities | 0 | 60,036 | 0 | 60,329 |
Series G Common Stock | ||||
Numerator: | ||||
Net (loss) income available to common stockholders | $ (320) | $ (480) | ||
Effect of dilutive securities: | ||||
Net (loss) income available to stockholders, diluted | $ (320) | $ (480) | ||
Denominator: | ||||
Basic net income (loss) per share | $ (0.32) | $ (0.48) | ||
Diluted net income (loss) per share | $ (0.32) | $ (0.48) | ||
Weighted-average shares outstanding, basic and diluted | 1 | 1 | ||
Series G Common Stock | Preferred Stock Warrants | ||||
Effect of dilutive securities: | ||||
Effect of dilutive securities | $ 0 | $ 0 | $ 0 | $ 0 |
Summary of Accounting Policie_4
Summary of Accounting Policies - Schedule of Dilutive Securities Excluded from Computation of Income (Loss) Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Convertible Preferred Stock | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 0 | 14,850,993 | 0 | 14,850,993 |
Stock Options Issued And Outstanding Under Plans | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 1,942,092 | 4,610,950 | 1,973,913 | 4,368,665 |
Restricted Stock Units [Member] | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 65,825 | 0 | 48,188 | 0 |
Employee Stock Purchase Plan | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 48,373 | 0 | 47,496 | 0 |
Summary of Accounting Policie_5
Summary of Accounting Policies - Schedule of Revenue From Contracts With Customers (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | $ 11,360 | $ 4,897 | $ 20,301 | $ 8,381 |
L D D | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | 5,683 | 2,965 | 10,253 | 4,802 |
LAL [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | 5,349 | 1,792 | 9,453 | 3,321 |
Service Warranty Service Contracts And Accessories | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | $ 328 | $ 140 | $ 595 | $ 258 |
Summary of Accounting Policie_6
Summary of Accounting Policies - Schedule of Deferred Revenue Activity (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Deferred Revenue [Abstract] | ||
Balance at beginning of period | $ 540 | $ 345 |
Additions during the period | 741 | 272 |
Recognized during the period | (543) | (237) |
Balance at end of period | $ 738 | $ 380 |
Short-Term Investment - Schedul
Short-Term Investment - Schedule of Short-term Investment Available For Sale (Details) - US Treasury Securities [Member] - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Short Term Debt [Line Items] | ||
Amortized Cost | $ 104,776 | $ 134,980 |
Unrealized Loss, Net | (160) | (9) |
Estimated Fair Value | $ 104,616 | $ 134,971 |
Short-Term Investment - Additio
Short-Term Investment - Additional Information (Details) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Maximum [Member] | Government Securities [Member] | ||
Short Term Debt [Line Items] | ||
Investment maturity period | 1 year | 1 year |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 4,656 | $ 4,451 |
Raw materials | 4,650 | 2,828 |
Work-in-process | 2,431 | 868 |
Inventory gross | 11,737 | 8,147 |
Less: reserve for excess and obsolete inventory | (115) | (115) |
Inventory net | $ 11,622 | $ 8,032 |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) $ in Millions | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Inventory held on consignment | $ 2.2 | $ 1.8 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of assets and liabilities measured at fair value on recurring basis and the fair value hierarchy of the valuation techniques (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Total assets at fair value | $ 127,454 | $ 156,361 |
Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 22,838 | 21,390 |
US Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | 104,616 | 134,971 |
Level I [Member] | ||
Assets: | ||
Total assets at fair value | 22,838 | 21,390 |
Level I [Member] | Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 22,838 | 21,390 |
Level I [Member] | US Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | 0 | 0 |
Level II [Member] | ||
Assets: | ||
Total assets at fair value | 104,616 | 134,971 |
Level II [Member] | Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 0 | 0 |
Level II [Member] | US Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | $ 104,616 | $ 134,971 |
Fair Value Measurements (Additi
Fair Value Measurements (Additional Information) (Details) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2022 | Jul. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | |||
Fair Value of unexercised warrants | $ 5 | ||
Convertible preferred stock, shares converted | 14,725,309 | ||
Series H Preferred Stock [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Convertible preferred stock, shares converted | 100,261 | ||
Warrants To Purchase Convertible Preferred Stock | 225,945 | ||
IPO [Member] | |||
Subsidiary, Sale of Stock [Line Items] | |||
Convertible preferred stock, shares converted | 14,376,272 |
Fair Value Measurements -Schedu
Fair Value Measurements -Schedule of estimated fair value for the warrant liabilities measured using significant unobservable inputs (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | ||
Beginning balance | $ 0 | $ 8,846 |
Expiration of common stock warrants | 0 | (5,018) |
Change in fair value of preferred stock warrants | 0 | (1,214) |
Ending balance | $ 0 | $ 2,614 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | 10 Months Ended | 12 Months Ended | |||||||
Nov. 01, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | May 03, 2022 | Jun. 30, 2022 | Oct. 31, 2022 | Oct. 31, 2023 | Jun. 30, 2021 | Mar. 31, 2021 | Oct. 31, 2020 | |
Debt Instrument [Line Items] | ||||||||||
Term Loan Description | The Amended Term Loan requires 35 months of interest-only payments, followed by 22-months of principal and accrued interest payments. If the Company is in compliance with its performance-to-plan covenant through April 1, 2025 and has not provided an IP lien election notice before May 1, 2025, the interest-only period is extended by 12 months, and the amortization period is reduced to ten months. Payments are due on the first day of each month in arrears. All unpaid amounts under the Amended Term Loan mature on February 1, 2027. | |||||||||
Loan, Description | Under the Amended Term Loan, a final payment (“Final Payment”) will be due at the earlier of the maturity date, acceleration of the loans, or a voluntary or mandatory prepayment of the loans, in an amount equal to (a) if the Final Payment is due on or after January 1, 2022 through and including October 31, 2022, three percent (3.00%) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid), (b) if the Final Payment is due on or after November 1, 2022 through and including October 31, 2023, four percent (4.00%) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid), and (c) if the Final Payment is due on or after November 1, 2023, five percent (5.00%) of the original principal amount of the loans (or, in the case of a partial prepayment, the amount of principal to be prepaid). The Final Payment is being accreted to the carrying value of the debt as a debt premium and interest expense over the life of the loan using the effective interest method. | |||||||||
Interest rate on borrowings term loan | (5.00%) | (3.00%) | (4.00%) | |||||||
Loan Amendment Fees And Other Closing Costs | $ 0.1 | |||||||||
Minimum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Payment of Loan, Partly | $ 5 | |||||||||
Term loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument face amount | $ 25 | |||||||||
Term loan additional borrowing | $ 10 | $ 5 | ||||||||
Term loan [Member] | Maximum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument face amount | $ 35 | |||||||||
Amended Term Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument face amount | $ 60 | |||||||||
Interest rate on borrowings term loan | 9.25% | |||||||||
Proceeds from Loan Originations | $ 10 | $ 10 | $ 40 | |||||||
Loan, Description of Variable Rates | The Amended Term Loan bears interest at a rate per annum equal to the greater of (i) 9.25% or (ii) 1-Month Term Secured Overnight Financing Rate (“SOFR”) (or, if greater, 0.16%) plus an applicable margin of 9.09%. If there is an event of default under the Amended Term Loan, additional interest of 5% applies. |
Term Loan - Future Principal Pa
Term Loan - Future Principal Payments Due Under the Term Loan (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2022 (remainder) | $ 0 | |
2023 | 0 | |
2024 | 0 | |
2025 | 16,364 | |
2026 | 21,818 | |
2027 | 1,818 | |
Total | 40,000 | |
Less: unamortized issuance costs and exit fee | (119) | |
Term loan, net | $ 39,881 | $ 39,760 |
Term Loan - Schedule of Cash In
Term Loan - Schedule of Cash Interest Paid and effective interest rate on term loan (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Debt Disclosure [Abstract] | ||||
Cash Interest Paid | 9.86% | 9.25% | 9.52% | 9.25% |
Effective interest rate | 11.50% | 10.90% | 11.05% | 11.09% |
Common Stock Warrant Liability
Common Stock Warrant Liability - Additional Information (Details) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 | Jul. 29, 2021 |
Class Of Warrant Or Right [Line Items] | |||
Common stock par value per share | $ 0.001 | $ 0.001 | $ 0.001 |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Deficit - Summary of Preferred Stock (Details) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Temporary Equity [Line Items] | ||
Par Value | $ 0.001 | $ 0.001 |
Shares Authorized | 100,000,000 | 100,000,000 |
Preferred Shares Issued | 0 | 0 |
Shares Outstanding | 0 | 0 |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Deficit - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2022 | Dec. 31, 2021 |
Class Of Stock [Line Items] | ||
Conversion of preferred stock | 7,520,201 | 6,878,511 |
Restricted Stock Units [Member] | ||
Class Of Stock [Line Items] | ||
Conversion of preferred stock | 585,448 | 640,479 |
Stock-Based Compensation Expe_3
Stock-Based Compensation Expense - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended | |||||
Jun. 02, 2022 | Jan. 03, 2022 | Jul. 28, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Mar. 08, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock issued (in shares) | 27,631,479 | 27,366,746 | |||||
Shares of common stock reserved | 7,520,201 | 6,878,511 | |||||
Total unrecognized expense related to unvested stock options | $ 8 | ||||||
Weighted average period for recognition of expenses | 2 years 10 months 24 days | ||||||
The Calhoun Vision, Inc. 2015 Equity Incentive Plan and the Calhoun Vision, Inc. 2006 Stock Plan [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Intrinsic Value of Vested Options | $ 19.1 | $ 14.7 | |||||
Intrinsic Value of Outstanding Options | 21.3 | $ 14.7 | |||||
Total Cash Received from the Exercise of Stock Options | 0.6 | $ 1.2 | |||||
Total Fair Value Less Strike Price of Stock Options Exercised | $ 1.2 | $ 3.1 | |||||
Number of Options, Unvested | 2,707,279 | 2,437,649 | |||||
Total unrecognized expense related to unvested stock options | $ 21 | $ 20.1 | |||||
Weighted average period for recognition of expenses | 3 years | ||||||
2021 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock available for issuance | 2,420,135 | ||||||
Common stock issued (in shares) | 7,260,406 | 1,094,670 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 4% | ||||||
Weighted average period for recognition of expenses | 2 years 10 months 24 days | ||||||
2021 Equity Incentive Plan | Maximum [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares of common stock reserved | 4,569,530 | ||||||
2021 Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock available for issuance | 711,643 | ||||||
Shares of common stock reserved | 1,452,081 | 273,667 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 1% | ||||||
2021 Employee Stock Purchase Plan | Maximum [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 85% | ||||||
Restricted Stock Units (RSUs) [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares of common stock reserved | 585,448 | 640,479 | |||||
Number of Options, Unvested | 585,448 | ||||||
Restricted Stock Units (RSUs) [Member] | Executive Officers and Non-Employee Directors [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock-Based Compensation, Vesting period | 1 year | 3 years | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 61,231 | 19,196 |
Stock-Based Compensation Expe_4
Stock-Based Compensation Expense - Summary of Stock Option Activities (Details) - The Calhoun Vision, Inc. 2015 Equity Incentive Plan and the Calhoun Vision, Inc. 2006 Stock Plan [Member] - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Beginning balance | 5,754,005 | |
Number of Options, Granted | 782,557 | |
Number of Options, Exercised | (140,826) | |
Number of Options, Forfeited | (83,717) | |
Number of Options, Expired | (88,909) | |
Number of Options, Ending balance | 6,223,110 | 5,754,005 |
Number of Options, Exercisable | 3,515,831 | |
Weighted-Average Exercise Price, Beginning balance | $ 11.64 | |
Weighted-Average Exercise Price, Options Granted | 12.46 | |
Weighted-Average Exercise Price, Options Exercised | 4.16 | |
Weighted-Average Exercise Price, Options Forfeited | 14.69 | |
Weighted-Average Exercise Price, Expired | 17.07 | |
Weighted-Average Exercise Price, Ending balance | 11.80 | $ 11.64 |
Weighted-Average Exercise Price, Exercisable | $ 10 | |
Weighted-Average Remaining Contractual Term (Years), Options outstanding | 6 years 10 months 2 days | 5 years 2 months 12 days |
Weighted-Average Remaining Contractual Term (Years), Exercisable | 5 years 2 months 4 days |
Stock-Based Compensation Expe_5
Stock-Based Compensation Expense - Summary of Non-Vested Restricted Stock Unit Activities (Details) - Restricted Stock Units (RSUs) [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unvested at December 31, 2021 | shares | 640,479 |
Number of Options, Granted | shares | 80,427 |
Number of shares, vested | shares | (104,839) |
Number of shares, forfeited | shares | (30,619) |
Unvested at June 30, 2022 | shares | 585,448 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 15.46 |
Weighted Average Grant Date Fair Value, Options Granted | $ / shares | 13.37 |
Weighted average fair value, vested | $ / shares | 15.64 |
Weighted average fair value, forfeited | $ / shares | 15.38 |
Weighted average fair value, Ending Balance | $ / shares | $ 15.14 |
Stock-Based Compensation Expe_6
Stock-Based Compensation Expense - Schedule of Stock-Based Compensation Expense (Details) - The Calhoun Vision, Inc. 2015 Equity Incentive Plan and the Calhoun Vision, Inc. 2006 Stock Plan [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 2,904 | $ 1,406 | $ 5,553 | $ 2,645 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 792 | 540 | 1,566 | 1,137 |
Selling, General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 1,866 | 686 | 3,520 | 1,149 |
Cost of Goods Sold | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 246 | $ 180 | $ 467 | $ 359 |
Stock-Based Compensation Expe_7
Stock-Based Compensation Expense - Schedule of Range and Weighted-average Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, Minimum | 62.40% | 62.30% |
Expected volatility, Maximum | 63.40% | 63.70% |
Risk-free interest rate, Minimum | 2% | 0.60% |
Risk-free interest rate, Maximum | 3% | 1.60% |
Expected dividend yield | 0% | 0% |
Expected volatility, Weighted Average | 62.70% | 63.60% |
Risk-free interest rate, Weighted Average | 2.20% | 1.10% |
Expected life (in years), Weighted Average | 6 years 1 month 6 days | 6 years |
Expected dividend yield, Weighted Average | 0% | 0% |
Grant date fair value, Weighted Average | $ 12.32 | $ 15.64 |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life (in years) | 10 years | 10 years |
Grant date fair value | $ 12.85 | $ 19.94 |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected life (in years) | 6 years | 5 years 6 months 7 days |
Grant date fair value | $ 10.74 | $ 15.60 |
Stock-Based Compensation Expe_8
Stock-Based Compensation Expense - Common stock reserved for future issuance (Details) - shares | Jun. 30, 2022 | Dec. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved | 7,520,201 | 6,878,511 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved | 585,448 | 640,479 |
Stock options issued and outstanding under the Equity Plans | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved | 6,223,110 | 5,754,005 |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares of common stock reserved | 711,643 | 484,027 |
Stockholders' Equity (Additiona
Stockholders' Equity (Additional Information) (Details) - $ / shares | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Jul. 29, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||||||
Common stock, authorized (in shares) | 900,000,000 | 900,000,000 | 900,000,000 | ||||
Preferred stock, shares authorized | 100,000,000 | 100,000,000 | |||||
Preferred stock par value per share | $ 0.001 | $ 0.001 | |||||
Preferred Shares Issued | 0 | 0 | |||||
Preferred stock, shares outstanding | 0 | 0 | |||||
Common stock issued (in shares) | 27,631,479 | 27,366,746 | |||||
Common stock outstanding (in shares) | 27,631,479 | 27,366,746 | |||||
Common Stock [Member] | |||||||
Class of Stock [Line Items] | |||||||
Common stock outstanding (in shares) | 27,631,479 | 27,485,685 | 27,366,746 | 4,124,211 | 4,093,996 | 1 | |
Convertible Preferred Stock | |||||||
Class of Stock [Line Items] | |||||||
Preferred stock, shares authorized | 100,000,000 | ||||||
Preferred stock par value per share | $ 0.001 | ||||||
Preferred stock, shares outstanding | 14,376,272 |
Leases - Additional Information
Leases - Additional Information (Details) | 6 Months Ended | |
Apr. 04, 2022 USD ($) | Jun. 30, 2022 USD ($) ft² Item | |
Lessee Lease Description [Line Items] | ||
Lease expiration date | Mar. 31, 2025 | |
Sublease agreement | 34 months | |
Lease Rent Payable | $ 11,410 | |
California [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating leases,tenant allowance | $ 900,000 | |
California [Member] | Maximum [Member] | ||
Lessee Lease Description [Line Items] | ||
Lease expiration date | Jan. 31, 2026 | |
Office, Manufacturing and Warehouse Facility [Member] | California [Member] | ||
Lessee Lease Description [Line Items] | ||
Number of leases | Item | 4 | |
Area of leased space | ft² | 121,000 | |
Lease expiration date | Aug. 31, 2024 |
Leases - Summary of Lease Balan
Leases - Summary of Lease Balances Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets | ||
Operating leases right-of-use assets | $ 4,704 | $ 4,284 |
Assets Finance | $ 265 | $ 33 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property and equipment, net | Property and equipment, net |
Total lease assets | $ 4,969 | $ 4,317 |
Current liabilities: | ||
Liabilities Current Operating | $ 1,716 | $ 1,509 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease liabilities | Lease liabilities |
Liabilities Current Finance | $ 126 | $ 20 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease liabilities | Lease liabilities |
Noncurrent | ||
Liabilities Noncurrent Operating | $ 3,744 | $ 3,625 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease liabilities | Long-term lease liabilities |
Liabilities Noncurrent Finance | $ 107 | $ 17 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease liabilities | Long-term lease liabilities |
Total lease liabilities | $ 5,693 | $ 5,171 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Lessee Lease Description [Line Items] | ||||
Finance lease cost | $ 4 | $ 1 | $ 7 | $ 3 |
Cost of Goods Sold | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease cost | 3 | 3 | 7 | 7 |
Research and Development | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease cost | 85 | 79 | 159 | 158 |
Finance lease cost | 32 | 46 | ||
Selling, General and Administrative | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease cost | 429 | 402 | 833 | 803 |
Finance lease cost | $ 4 | $ 7 | $ 9 | $ 14 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilites (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Operating Leases | |
2022 (remainder) | $ 1,024 |
2023 | 2,058 |
2024 | 1,788 |
2025 | 1,002 |
2026 | 80 |
2027 | 0 |
Total lease payments | 5,952 |
Less: imputed interest | (492) |
Total lease liabilities | 5,460 |
Finance Leases | |
2022 (remainder) | 65 |
2023 | 149 |
2024 | 36 |
2025 | 6 |
2026 | 0 |
2027 | 0 |
Total lease payments | 256 |
Less: imputed interest | (23) |
Total lease liabilities | $ 233 |
Leases - Summary of Weighted Av
Leases - Summary of Weighted Average Remaining Lease Term and Discount Rate (Details) | Jun. 30, 2022 | Dec. 31, 2021 |
Weigted average remaining lease term (years) | ||
Weighted average remaining lease term - operating leases | 2 years 10 months 13 days | 3 years 3 months 18 days |
Weighted average remaining lease term - finance leases | 1 year 9 months 10 days | 1 year 8 months 19 days |
Weighted average discount rate | ||
Weighted average discount rate - operating leases (as a percent) | 10.30% | 10.50% |
Weighted average discount rate - finance leases (as a percent) | 9.50% | 10.50% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Loss Contingencies [Line Items] | ||
Legal proceedings, regulatory matters, legal costs | $ 0 | $ 0 |
Letter of Credit [Member] | ||
Loss Contingencies [Line Items] | ||
Aggregate amount of the letter of credit | $ 310,000 | $ 310,000 |