Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
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 | |
Securities Act 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 $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 35,643,669 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,753 | $ 11,834 |
Short-term investments | 138,340 | 93,968 |
Accounts receivable | 13,295 | 10,956 |
Inventories | 17,945 | 14,835 |
Prepaid and other current assets | 2,112 | 2,962 |
Total current assets | 180,445 | 134,555 |
Property and equipment, net | 10,533 | 10,138 |
Operating leases right-of-use assets | 3,174 | 3,943 |
Restricted cash | 761 | 761 |
Other assets | 348 | 767 |
Total assets | 195,261 | 150,164 |
Current liabilities: | ||
Accounts payable | 3,997 | 2,595 |
Accrued expenses and other current liabilities | 10,588 | 12,672 |
Lease liabilities | 1,980 | 1,970 |
Total current liabilities | 16,565 | 17,237 |
Long-term lease liabilities | 1,843 | 2,856 |
Term loan, net | 19,589 | 40,169 |
Other long-term liabilities | 76 | 0 |
Total liabilities | 38,073 | 60,262 |
Commitments and contingencies (Note 9) | ||
Stockholders' deficit: | ||
Common stock, $0.001 par value, 900,000,000 shares authorized, 35,168,041 shares issued and outstanding as of June 30, 2023 and 28,268,389 shares issued and outstanding as of December 31, 2022 | 35 | 28 |
Preferred stock, $0.001 par value, 100,000,000 shares authorized, no shares issued and outstanding | 0 | 0 |
Additional paid-in capital | 730,274 | 636,001 |
Accumulated other comprehensive loss | (73) | (95) |
Accumulated deficit | (573,048) | (546,032) |
Total stockholders' deficit | 157,188 | 89,902 |
Total liabilities and stockholders' equity | $ 195,261 | $ 150,164 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Common stock par value (USD per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 900,000,000 | 900,000,000 |
Common stock shares issued | 35,168,041 | 28,268,389 |
Common stock outstanding (in shares) | 35,168,041 | 28,268,389 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Sales | $ 20,810 | $ 11,360 | $ 38,299 | $ 20,301 |
Cost of sales | 8,795 | 6,572 | 15,919 | 11,752 |
Gross profit | 12,015 | 4,788 | 22,380 | 8,549 |
Operating expenses: | ||||
Selling, general and administrative | 18,239 | 14,388 | 34,492 | 28,008 |
Research and development | 7,401 | 6,192 | 14,608 | 12,911 |
Total operating expenses | 25,640 | 20,580 | 49,100 | 40,919 |
Loss from operations | (13,625) | (15,792) | (26,720) | (32,370) |
Other income (expense), net: | ||||
Interest expense | (1,568) | (1,136) | (3,075) | (2,196) |
Interest and other income | 1,777 | 196 | 3,168 | 242 |
Loss on extinguishment of term loan | (362) | 0 | (362) | 0 |
Loss before income taxes | (13,778) | (16,732) | (26,989) | (34,324) |
Income tax (benefit) expense | 26 | 0 | 27 | 4 |
Net loss | (13,804) | (16,732) | (27,016) | (34,328) |
Other comprehensive loss | ||||
Unrealized gain (loss) on short-term investments | (65) | (76) | 19 | (150) |
Foreign currency translation loss | 1 | (9) | 3 | (13) |
Total other comprehensive (loss) income | (64) | (85) | 22 | (163) |
Comprehensive loss | $ (13,868) | $ (16,817) | $ (26,994) | $ (34,491) |
Net loss per share: | ||||
Attributable to common stock, basic | $ (0.4) | $ (0.61) | $ (0.82) | $ (1.25) |
Attributable to common stock, diluted | $ (0.4) | $ (0.61) | $ (0.82) | $ (1.25) |
Weighted-average shares used in computing net loss per share: | ||||
Attributable to common stock, basic | 34,498,265 | 27,559,908 | 33,075,585 | 27,493,130 |
Attributable to common stock, diluted | 34,498,265 | 27,559,908 | 33,075,585 | 27,493,130 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
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 | ||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Amount | 308 | 308 | |||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 145,922 | ||||
Shares redeemed for employee tax withholdings, Amount | (362) | (362) | |||
Shares redeemed for employee tax withholdings, Shares | (26,983) | ||||
Stock-based compensation expense | 2,649 | 2,649 | |||
Unrealized gain (loss) 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 | ||||
Unrealized gain (loss) 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 | ||||
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, Amount | 277 | 277 | |||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 99,743 | ||||
Stock-based compensation expense | 2,904 | 2,904 | |||
Shares issued for the employee stock purchase plan, Amount | 459 | 459 | |||
Shares issued for the employee stock purchase plan, Shares | 46,051 | ||||
Unrealized gain (loss) on short-term investments and cash equivalents, net of tax | (76) | (76) | |||
Foreign currency translation adjustment | (9) | (9) | |||
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 | ||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2022 | $ 89,902 | $ 28 | 636,001 | (95) | (546,032) |
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2022 | 28,268,389 | 28,268,389 | |||
Shares issued for the exercise of stock options and vesting of restricted stock units, Amount | $ 761 | 761 | |||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 243,598 | ||||
Shares redeemed for employee tax withholdings, Amount | (337) | (337) | |||
Shares redeemed for employee tax withholdings, Shares | (24,631) | ||||
Stock-based compensation expense | 3,295 | 3,295 | |||
Issuance of common stock for public offering, net of underwriting discounts, commissions and offering costs, Amount | 53,600 | $ 5 | 53,595 | ||
Issuance of common stock for public offering, net of underwriting discounts, commissions and offering costs, Shares | 4,600,000 | ||||
Issuance of common stock for at-the-market offerings, net of issuance costs, Amount | 10,914 | $ 1 | 10,913 | ||
Issuance of common stock for at-the-market offerings, net of issuance costs, Shares | 879,341 | ||||
Unrealized gain (loss) on short-term investments and cash equivalents, net of tax | 84 | 84 | |||
Foreign currency translation adjustment | 2 | 2 | |||
Net loss | (13,212) | (13,212) | |||
Stockholders' Equity, Ending Balance, Amount at Mar. 31, 2023 | 145,009 | $ 34 | 704,228 | (9) | (559,244) |
Stockholders' Equity, Ending Balance, Shares at Mar. 31, 2023 | 33,966,697 | ||||
Stockholders' Equity, Beginning Balance, Amount at Dec. 31, 2022 | $ 89,902 | $ 28 | 636,001 | (95) | (546,032) |
Stockholders' Equity, Beginning Balance, Shares at Dec. 31, 2022 | 28,268,389 | 28,268,389 | |||
Unrealized gain (loss) on short-term investments and cash equivalents, net of tax | $ 19 | ||||
Net loss | (27,016) | ||||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2023 | $ 157,188 | $ 35 | 730,274 | (73) | (573,048) |
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2023 | 35,168,041 | 35,168,041 | |||
Stockholders' Equity, Beginning Balance, Amount at Mar. 31, 2023 | $ 145,009 | $ 34 | 704,228 | (9) | (559,244) |
Stockholders' Equity, Beginning Balance, Shares at Mar. 31, 2023 | 33,966,697 | ||||
Shares issued for the exercise of stock options and vesting of restricted stock units, Amount | 2,599 | 2,599 | |||
Shares issued for the exercise of stock options and vesting of restricted stock units, Shares | 316,092 | ||||
Stock-based compensation expense | 3,955 | 3,955 | |||
Shares issued for the employee stock purchase plan, Amount | 536 | 536 | |||
Shares issued for the employee stock purchase plan, Shares | 50,504 | ||||
Issuance of common stock for at-the-market offerings, net of issuance costs, Amount | 18,957 | $ 1 | 18,956 | ||
Issuance of common stock for at-the-market offerings, net of issuance costs, Shares | 834,748 | ||||
Unrealized gain (loss) on short-term investments and cash equivalents, net of tax | (65) | (65) | |||
Foreign currency translation adjustment | 1 | 1 | |||
Net loss | (13,804) | (13,804) | |||
Stockholders' Equity, Ending Balance, Amount at Jun. 30, 2023 | $ 157,188 | $ 35 | $ 730,274 | $ (73) | $ (573,048) |
Stockholders' Equity, Ending Balance, Shares at Jun. 30, 2023 | 35,168,041 | 35,168,041 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Proceeds from Issuance of Common Stock | $ 3,896 | $ 1,044 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating Activities: | ||
Net loss | $ (27,016) | $ (34,328) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,944 | 2,025 |
Amortization of right-of-use lease assets | 85 | 56 |
Amortization of debt issuance costs and premium | 283 | 265 |
Loss on extinguishment of debt | 362 | 0 |
Amortization of discount on short-term investments | (2,953) | (231) |
Stock-based compensation | 7,250 | 5,553 |
Provision for excess and obsolete inventory | 14 | 120 |
Change in operating assets and liabilities: | ||
Accounts receivable | (2,338) | (2,022) |
Inventories | (3,124) | (3,710) |
Prepaid and other assets | 868 | 1,099 |
Accounts payable | 1,324 | 1,348 |
Accrued expenses and other liabilities | (2,009) | 17 |
Net cash used in operating activities | (25,310) | (29,808) |
Investing Activities: | ||
Purchases of property and equipment | (2,570) | (1,451) |
Maturities of short-term investments | 115,000 | 135,000 |
Purchases of short-term investments | (156,400) | (104,564) |
Net cash (used in) provided by investing activities | (43,970) | 28,985 |
Financing Activities: | ||
Proceeds from term loan | 20,000 | 0 |
Repayment of term loan | (40,000) | 0 |
Proceeds from issuance of common stock from public offering | 54,050 | 0 |
Proceeds from issuance of common stock in at-the-market offerings | 30,496 | 0 |
Proceeds from issuance of common stock | 3,896 | 1,044 |
Payments for employee taxes related to stock compensation | (337) | (362) |
Principal payments on finance lease liabilities | (82) | (60) |
Payments of deferred offering costs | (602) | 0 |
Payments of debt issuance costs | (1,225) | (142) |
Net cash provided by financing activities | 66,196 | 480 |
Effect of foreign exchange rate on cash, cash equivalents and restricted cash | 3 | (14) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (3,081) | (357) |
Cash, cash equivalents and restricted cash - beginning of period | 12,595 | 25,172 |
Cash, cash equivalents and restricted cash - end of period | 9,514 | 24,815 |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | 1,107 | 1,023 |
Cash paid for income taxes | 12 | 3 |
Cash paid for interest on financing leases | 7 | 3 |
Cash paid for interest on term loan | 3,240 | 1,904 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating lease | 0 | 1,090 |
Finance lease | 0 | 288 |
Lease obligations recorded for right-of-use assets: | ||
Operating lease | 0 | 1,090 |
Finance lease | 0 | 256 |
Acquisition of property and equipment included in accounts payable and accrued expenses and other current liabilities | 408 | 238 |
Deferred offering costs included in accounts payable and accrued liabilities | 187 | |
Reclassification of deferred financing costs | $ (1,075) | $ 0 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
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”) primarily for sale in the U.S. and have regulatory approval in the U.S., Europe, Canada and Mexico. The Company began marketing its products in 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. 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, 2022 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 audited consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K filed with the SEC on March 6, 2023. 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. Operating Segments The Company determined its operating segment on the same basis that it uses to evaluate its performance internally. The Company’s chief operating decision-maker (“CODM”), its Chief Executive Officer, reviews its consolidated operating results for the purpose of allocating resources and evaluating financial performance. The Company determined that it operates and manages its business (including its non-U.S. subsidiaries) in one reportable segment: the research and development, manufacture and sale of light adjustable lenses and related capital equipment. Liquidity Shelf Registration Statement On August 8, 2022, the Company filed a $ 200.0 million shelf registration statement on Form S-3 (“shelf registration statement”) which became effective on August 12, 2022. The shelf registration statement is effective for three years and permits the Company to sell, from time to time, up to $ 200.0 million in aggregate value of common stock, preferred stock, debt securities, warrants, and/or units. The shelf registration statement is intended to provide the Company with flexibility to access additional capital. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement to sell up to an aggregate value of $ 50.0 million dollars of common stock through an “at-the-market” (“ATM”) offering. ATM Offering As of June 30, 2023, through the ATM offering, a total of 2,189,964 shares of the Company's common stock, for total net proceeds of $ 35.8 million, have been issued and sold, of which 1,714,089 shares of the Company's common stock, for net proceeds of $ 29.9 million, were sold during the six months ended June 30, 2023. Public Offering On February 7, 2023 , the Company entered into an underwriting agreement with BofA Securities, Inc., in which the Company agreed to issue and sell 4,000,000 shares of the Company's common stock in a public offering (“Public Offering”), pursuant to the shelf registration statement. The shares of common stock were sold at a price to the public of $ 12.50 per share. Under the terms of the underwriting agreement, the Company also granted the underwriters an option exercisable for 30 days from the date of the underwriting agreement to purchase up to an additional 600,000 shares of common stock on the same terms and conditions. The underwriters' option was exercised in full on February 10, 2023 and closed on February 14, 2023. The Company received net proceeds of approximately $ 53.6 million from the Public Offering, after deducting underwriters' discounts and commissions of $ 3.5 million and offering expenses of $ 0.5 million. As of June 30, 2023 and December 31, 2022 the Company had cash, cash equivalents and short-term investments of $ 147.1 million and $ 105.8 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, 2023 and 2022, the Company incurred losses from operations of $ 13.6 million and $ 15.8 million, respectively. For the six months ended June 30, 2023 and 2022, the Company incurred losses from operations of $ 26.7 million and $ 32.4 million, respectively. Based on the Company’s anticipated sales growth in relation to the anticipated costs associated with, among other things, its continuing research and development activities and the 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, 2023 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, 2023 | |
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, 2023 , 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 6, 2023. 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 $ 57,000 and $ 75,000 of unrealized losses related to short-term investments as of June 30, 2023 and December 31, 2022 , 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. A portion of the Company's operating cash is held in accounts in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limits; however, 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 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, 2023 and December 31, 2022 the Company did not have any customers who individually accounted for greater 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, 2023 or December 31, 2022 . 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. 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. 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. Cash, cash equivalents, accounts receivable and accounts payable are carried at their estimated fair value because of the short-term nature of these assets and liabilities. The Company’s short-term investments in government securities are carried at fair value, determined based on publicly available quoted market prices for identical securities at the measurement date. The Company believes the fair values of its operating lease liabilities, new loan and security agreement and amended term loan at June 30, 2023 and December 31, 2022 approximated their carrying values, based on the borrowing rates that were available for loans with similar terms as of such date. 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 Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average shares of common stock outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average shares of common stock and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock and potential dilutive securities outstanding during the period. 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 was anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 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 5,821,076 1,942,092 3,409,842 1,973,913 Restricted stock units issued under the 2021 Equity Incentive Plan 773,940 65,825 671,956 48,188 Stock issuable in offering period under the 2021 Employee Stock Purchase Plan 39,568 48,373 45,191 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: (i) LDD capital asset and related components, (ii) training and (iii) 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 generally 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, 2023 and 2022, credits related to returns and rebates on list prices were not significant. The Company has 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. Revenue for service agreements is recognized ratably over the term of each contract. For the three and six months ended June 30, 2023 and 2022, contract liabilities from sales activity recorded as liabilities on the Company's condensed consolidated balance sheets consisted of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 LDD (including training) $ 7,720 $ 5,683 $ 14,195 $ 10,253 LAL 12,411 5,349 22,806 9,453 Service warranty, service contracts, and accessories 679 328 1,298 595 $ 20,810 $ 11,360 $ 38,299 $ 20,301 As of June 30, 2023 and December 31, 2022, the Company recognized contract liabilities on its condensed consolidated balance sheets of $ 1,351,000 and $ 1,187,000, 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, 2023 and 2022, respectively (in thousands): Six Months Ended June 30, 2023 2022 Balance at beginning of period $ 1,193 $ 540 Additions during the period 1,391 741 Revenue recognized during the period ( 1,233 ) ( 543 ) Balance at end of period $ 1,351 $ 738 For the three and six months ended June 30, 2023 and 2022 , the Company did not have any customers who individually accounted for greater than 10 % of revenue. Stock-Based Compensation Expense The Company has three equity 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 of directors of the Company (the “Board”) and consultants and provide them with an incentive to promote the Company’s success and accomplish corporate goals. Stock option awards are 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: (i) one fourth of the total number of shares vest and become exercisable on the one-year anniversary and then 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; or (ii) 1/48th of the total number of shares subject to the option vest and become exercisable each month over four 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 Board at the time of each option grant by considering a number of objective and subjective factors. These factors included the valuation of a select group of public peer group companies within the medical device industry that focus on technological advances and development that the Board believed were comparable to the Company’s operations. Operating and financial performance, the lack of liquidity of the common stock and trends in the broader economy and medical device industry also impacted the determination of the fair value of the common stock. In addition, the Company regularly engaged a third-party valuation specialist to assist with estimates related to the valuation of the Company’s common stock. For all grants subsequent to commencement of trading of the Company's shares on the Nasdaq Global Market in July 2021, the fair value of common stock was determined by using the closing price per share of 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. The Black-Scholes option-pricing model requires the use of assumptions about a number of variables, such as the fair market value of the Company’s common stock, expected term, expected volatility, the risk-free interest rate, and dividend yield as discussed below. 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 initial public offering (“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. 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”). There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended June 30, 2023 that are of significance or potential significance to the Company. 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, 2023 | |
Short-Term Investments [Abstract] | |
Short-Term Investment | Note 3 – Short-Term Investments Short-term investments, principally U.S. Treasury bills, are available-for-sale and consisted of the following (in thousands): As of June 30, 2023 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 138,397 $ ( 57 ) $ 138,340 As of December 31, 2022 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 94,043 $ ( 75 ) $ 93,968 All available-for-sale securities held as of June 30, 2023 and December 31, 2022 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, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 4 – Inventories Inventories consisted of the following (in thousands): June 30, December 31, 2023 2022 Finished goods $ 7,757 $ 6,408 Raw materials 5,719 6,494 Work-in-process 4,868 2,567 18,344 15,469 Less: reserve for excess and obsolete inventory ( 399 ) ( 634 ) $ 17,945 $ 14,835 At June 30, 2023 and December 31, 2022, finished goods included $ 5.4 million and $ 2.8 million of inventory held on consignment at customer sites, respectively. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 5 – Fair Value Measurements The table and disclosures for the periods presented 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. The Company did not have any assets or liabilities measured at fair value on a recurring basis within Level 3 fair value measurements. As of June 30, 2023 Level I Level II Total Assets: Money market securities $ 5,391 $ — $ 5,391 U.S. Treasury securities — 138,340 138,340 Total assets at fair value $ 5,391 $ 138,340 $ 143,731 As of December 31, 2022 Level I Level II Total Assets: Money market securities $ 8,909 $ — $ 8,909 U.S. Treasury securities — 93,968 93,968 Total assets at fair value $ 8,909 $ 93,968 $ 102,877 |
Term Loan
Term Loan | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Term Loan | Note 6 – Term Loans Refinancing and Payoff of Oxford Debt On October 29, 2020, the Company and Oxford Finance LLC (“Oxford”), as collateral agent, and certain lenders (“Lenders”) entered into that certain Loan and Security Agreement, as amended by that certain Consent and First Amendment to Loan and Security Agreement, dated as of July 6, 2021, and that certain Second Amendment to Loan and Security Agreement, dated as of May 3, 2022 (the “May 2022 LSA”), pursuant to which the Lenders provided to us certain loans in accordance with the terms and conditions of the May 2022 LSA (such loans collectively, the “May 2022 Term Loan”). On June 30, 2023, the Company entered into a new Loan and Security Agreement (the “June 2023 LSA”) with Oxford as collateral agent and the lenders party thereto, pursuant to which the Company borrowed $ 20.0 million in aggregate Term A Loans (the “Term A Loans”). On that same date, the Company prepaid the May 2022 Term Loan in full using a combination of cash, primarily comprised of $ 19.4 million of net cash raised under the ATM Facility during the quarter ended June 30, 2023, $ 20.0 million in Term A Loans and $ 1.7 million in cash reserves. On August 4, 2023, the Company prepaid the Term A Loans in full, including accrued interest and fees, using $ 11.9 million of cash, net, raised under the ATM Facility subsequent to June 30, 2023 and $ 9.3 million in cash reserves. New Loan and Security Agreement Under the June 2023 LSA, the Company may borrow additional term loans of up to $ 40.0 million in aggregate principal, in four tranches and subject to the Company achieving certain revenue milestones and satisfying customary conditions precedent (each a “Term Loan” and together with the Term A Loans, the “Loans”). For each such additional tranche of Term Loans, an unused term loan commitment fee equal to 1.00 % of the total earned amount of such additional tranche will be due and payable on the earliest to occur of (a) the expiration of the draw period for such additional tranche, (b) the acceleration of any Term Loan during the draw period for such additional tranche or (c) the voluntary or mandatory prepayment of all of the Term Loans during the draw period for such additional tranche (including in each case, as a result of an event of default as defined in the June 2023 LSA during the draw period for such additional tranche). Each Loan bears interest at a floating per annum rate equal to (a) the greater of (i) the 1-Month Term SOFR on the last business day of the month that immediately precedes the month in which the interest will accrue and (ii) 5.15%, plus (b) 6.35%; provided, in no event will the interest rate for any Loan be less than 11.50% per annum. Upon any event of default as defined in the June 2023 LSA, the interest rate will increase to 5.0 % above the applicable interest rate. The Loans mature on June 1, 2028 . Principal repayment will commence on August 1, 2026 in equal monthly installments of the outstanding Loan balance through the maturity date. If the Company is in compliance with its revenue covenant in the June 2023 LSA for each quarterly measuring date from June 30, 2023 through July 1, 2026 and if it has not elected to pledge its intellectual property as collateral security for the Loans before August 1, 2026, then principal repayment will begin on August 1, 2027 . The Loans and June 2023 LSA are secured by substantially all of the Company’s personal property other than the Company’s 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 Company may elect to prepay the outstanding Loans, in whole but not in part, at any time. After August 31, 2024, the Company may also elect to prepay part of the outstanding Loans. Upon a voluntary or mandatory prepayment of the Loans, the Company is required to pay the lenders’ expenses and all accrued but unpaid interest on the Loans through the prepayment date. A final payment fee (“Final Payment Fee”) equal to 5.0 % of the original principal amount of the Loans advanced will be due at the earlier of the maturity date, acceleration of the Loans, or a voluntary or mandatory prepayment of the Loans (including as a result of an event of default as defined in the June 2023 LSA). The Company paid $ 0.1 million in closing costs that are directly attributable to execution of the June 2023 LSA transaction. The Final Payment Fee and closing costs were accreted to the carrying value of the debt as a debt premium and are being amortized to interest expense over the life of the loan using the effective interest method. The June 2023 LSA includes customary representations and covenants that, subject to exceptions and qualifications, restrict the Company’s ability to do the following things: engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; engage in businesses that are not related to the Company’s existing business; add or change business locations; incur additional indebtedness; incur additional liens; make loans and investments; declare dividends or redeem or repurchase equity interests; and make certain amendments or payments in respect of any subordinated debt. In addition, the June 2023 LSA contains customary affirmative covenants, including covenants regarding the payment of taxes and other obligations, maintenance of insurance, maintenance of the Company’s bank accounts, protection of the Company’s intellectual property, reporting requirements, compliance with applicable laws and regulations, and formation or acquisition of new subsidiaries. The June 2023 LSA also contains a performance to plan revenue covenant, unless the Company elects to grant a first priority security interest in its intellectual property to secure the Loans and Company’s obligations under the June 2023 LSA. The Company refers to its $ 60.0 million June 2023 LSA as its credit facility. The June 2023 LSA was recorded as a debt modification. Upon the occurrence and during the continuance of an event of default, the lenders may declare all outstanding principal, interest and other amounts under the June 2023 LSA immediately due and payable and may exercise the other rights and remedies provided for under the June 2023 LSA and related loan documents. The events of default under the June 2023 LSA include, subject to grace periods in certain instances, payment defaults, breaches of covenants or representations and warranties, a material adverse change as defined in the June 2023 LSA and with respect to certain governmental approvals, material judgments and attachments, bankruptcy and insolvency events with respect to the Company and its subsidiaries, defaults under other material indebtedness or subordinated debt, and delisting of the Company’s shares from the Nasdaq Global Market or a similar stock exchange. May 2022 Term Loan On May 3, 2022, the Company entered into the May 2022 Term Loan. The May 2022 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 May 2022 Term Loan, the Company could have borrowed an additional amount of up to $ 10.0 million through June 30, 2023, upon satisfaction of the applicable drawdown conditions and achievement of 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 May 2022 Term Loan, the Company could have borrowed an additional amount of up to $ 10.0 million through September 30, 2023, upon satisfaction of the applicable drawdown conditions and achievement of sufficient trailing twelve-month sales as provided in the agreement for the measurement period ending June 30, 2023. The May 2022 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 was an event of default under the May 2022 Term Loan additional interest of 5.0% applies. The May 2022 Term Loan extended the maturity date of the loan and security agreement, which was due to expire on October 1, 2025, to February 1, 2027. The May 2022 Term Loan was recorded as a debt modification. The May 2022 Term Loan was 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 May 2022 Term Loan also included certain customary representations and warranties, affirmative and negative covenants, and events of default, including a financial performance-to-plan covenant that required the Company to achieve certain minimum net sales, measured on a trailing twelve-month basis. The May 2022 Term Loan required 35 months of interest-only payments, followed by 22-months of principal and accrued interest payments. If the Company was in compliance with its performance-to-plan covenant through April 1, 2025 and had not provided an IP lien election notice before May 1, 2025, the interest-only period would have been extended by 12 months, and the amortization period would have been reduced to ten months. Payments were due on the first day of each month in arrears. All unpaid amounts under the May 2022 Term Loan were to mature on February 1, 2027. The Company could have elected to prepay the loans under the credit facility at any time in full or in part; however, the Company could have elected 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 May 2022 Term Loan, a final payment (“Final Payment”) would have been 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 Company paid $0.1 million in loan amendment fees and other closing costs that are directly attributable to execution of the May 2022 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. As of June 30, 2023 and December 31, 2022, the Company was in compliance with the June 2023 LSA and May 2022 Term Loan covenants, respectively. For the three and six months ended June 30, 2023 and 2022 the cash interest paid and effective interest rate on the June 2023 LSA and May 2022 Term Loan were as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, 2023 2022 2023 2022 Cash interest paid 14.07 % 9.86 % 13.85 % 9.52 % Effective interest rate 15.48 % 11.50 % 15.25 % 11.05 % As of June 30, 2023 future principal payments due under the June 2023 LSA were as follows (in thousands): Year Ended December 31, 2023 (remainder) $ — 2024 — 2025 — 2026 4,348 2027 10,435 2028 5,217 Total 20,000 Less: exit fee and unamortized issuance costs ( 411 ) Term loan, net $ 19,589 See Note 10 - Subsequent Events for further information. |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | Note 7 – Stock-Based Compensation Expense The Company has three equity incentive compensation plans: the 2006 Plan, the 2015 Plan and the 2021 Plan. 2006 Plan The 2006 Plan was originally adopted by the Board and approved by the Company’s stockholders in 2006. The 2006 Plan was terminated in 2015 in connection with the adoption of the 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 2015 Plan was originally adopted by the 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 2021 Plan was adopted and approved by the Board and stockholders prior to the IPO and became effective on the business day immediately prior to the effective date of the Company’s IPO registration statement. 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 (“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 originally available for issuance under the 2021 Plan was 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 equal to 4,569,530 shares of common stock. Evergreen provision 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 our common stock; (ii) 4 % of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser number of shares of our common stock as the administrator may determine. The 2021 Plan is administered by the Board. On January 1, 2022, the number of shares available under the 2021 Plan increased by 1,094,670 shares of common stock pursuant to this feature. On January 1, 2023, the number of shares available under the 2021 Plan further increased by 1,130,735 shares of common stock pursuant to this feature. As of June 30, 2023, the number of shares of the Company’s common stock available for future issuance under the 2021 Plan was equal to 431,050 shares of common stock 2021 ESPP On July 28, 2021, the Board and stockholders adopted and approved the 2021 ESPP. As of June 30, 2023 , the number of shares of the Company’s common stock available for future issuance under the 2021 ESPP was equal to 614,472 shares of common stock. 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. Evergreen provision The number of common shares reserved for issuance under the 2021 ESPP plan will be increased automatically on the first day of each fiscal year beginning with the 2022 fiscal year, by a number equal to the least of: (i) 1,452,081 shares; (ii) 1 % of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year; or (iii) such other amount as the administrator may determine. The 2021 ESPP is administered by the Board. On January 1, 2022, the number of shares available under the 2021 ESPP increased by 273,667 shares of common stock pursuant to this feature. No additional shares were reserved for issuance on January 1, 2023 pursuant to this feature. Stock-Based Compensation Expense The purpose of the 2021 Plan and 2021 ESPP is to provide a means by which eligible recipients of stock awards 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 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: (i) 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, or (ii) 1/48th of the total number of shares subject to the option vest and become exercisable each month over four years. A summary of the stock option activities related to the Equity Plans for the six months ended June 30, 2023 is presented below: Number of Options Weighted Weighted Avg Options outstanding as of December 31, 2022 6,339,558 $ 11.88 6.48 Granted 1,315,591 15.09 Exercised ( 415,456 ) 8.09 Forfeited ( 88,582 ) 13.26 Expired ( 62,392 ) 18.49 Options outstanding as of June 30, 2023 7,088,719 12.62 6.84 Exercisable as of June 30, 2023 4,016,925 $ 11.24 5.30 As of June 30, 2023 and December 31, 2022 the intrinsic value of options vested was $ 70.5 million and $ 15.9 million, respectively, and of all options outstanding was $ 114.7 million and $ 16.4 million, respectively. During the six months ended June 30, 2023 and 2022 , the total cash received from the exercise of stock options was $ 3.4 million and $ 0.6 million, respectively. The total fair value less strike price of these options was $ 5.2 million and $ 1.2 million, respectively. A summary of non-vested restricted stock unit activities for the six months ended June 30, 2023 is as follows: Weighted Average Number of Grant Date Shares Fair Value Unvested at December 31, 2022 492,862 $ 15.08 Granted 430,926 16.00 Vested ( 144,234 ) 14.43 Forfeited ( 6,105 ) 15.12 Unvested at June 30, 2023 773,449 $ 15.72 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, 2023 2022 2023 2022 Research and development $ 1,021 $ 792 $ 1,823 $ 1,566 Selling, general and administrative 2,639 1,866 4,910 3,520 Cost of goods sold 295 246 517 467 $ 3,955 $ 2,904 $ 7,250 $ 5,553 As of June 30, 2023 and December 31, 2022 , there were 3,071,794 and 2,447,687 unvested options, respectively. As of June 30, 2023 and December 31, 2022 , total unrecognized expense related to unvested stock options was approximately $ 25.9 million and $ 19.1 million, respectively. Amounts are expected to be recognized over a weighted average period of approximately 2.7 and 2 .6 years, respectively. As of June 30, 2023, and December 31, 2022 , total unrecognized expense related to non-vested restricted stock units was approximately $ 10.9 million and $ 6.1 million, respectively. The unrecognized compensation cost is expected to be recognized over a weighted average period of 2.8 years and 2.3 years, respectively. 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, 2023 2022 Range Weighted Average Range Weighted Average Expected volatility 64.9 % to 65.7 % 65.1 % 62.4 % to 63.4 % 62.7 % Risk-free interest rate 3.4 % to 4.2 % 4.1 % 2.0 % to 3.0 % 2.2 % Expected life (in years) 6.0 to 10.0 years 6.0 years 6.0 to 10.0 years 6.1 years Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Grant date fair value $ 12.91 to $ 28.80 $ 15.26 $ 10.74 to $ 12.85 $ 12.32 Common Stock Each share of common stock is entitled to one vote. Common stock reserved for future issuance under the Equity Plans, 2021 ESPP and the ATM offering consisted of the following: June 30, 2023 December 31, 2022 Stock options issued and outstanding under the Equity Plans 7,088,719 6,339,558 Shares available for future issuance under the Equity Plans 431,050 865,122 Restricted stock units issued under the 2021 Plan 773,449 492,862 Shares available for future issuance under 2021 ESPP 614,472 664,976 Shares available for future sale under the ATM offering (1) 427,892 3,454,064 Total shares of common stock reserved 9,335,582 11,816,582 (1) Based on the closing stock price of $ 28.80 as reported on the Nasdaq Global Market on June 30, 2023 . |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 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. On January 4, 2023 the Company entered into a second amendment to the sublease agreement adjusting the base rent receivable to $ 5,319 per month. The following table presents the lease balances within the Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022 (in thousands): June 30, December 31, Leases Classification 2023 2022 Assets Operating Operating leases right-of-use assets $ 3,174 $ 3,943 Finance Property and equipment, net 84 206 Total lease assets 3,258 4,149 Liabilities Current Operating Lease liabilities 1,902 1,818 Finance Lease liabilities 78 152 Noncurrent Operating Long-term lease liabilities 1,843 2,813 Finance Long-term lease liabilities — 43 Total lease liabilities $ 3,823 $ 4,826 For the three and six months ended June 30, 2023 and 2022, 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 2023 2022 2023 2022 Operating lease cost Cost of sales $ 3 $ 3 $ 7 $ 7 Research and development 24 85 61 159 Selling, general and administrative 438 429 887 833 Finance lease cost Research and development 29 32 63 46 Selling, general and administrative 9 4 18 9 Finance lease cost Interest expense 2 4 7 7 Maturities of the Company’s operating and finance lease liabilities as of June 30, 2023 were as follows (in thousands): Operating Finance Year Ended December 31, Leases Leases 2023 (remainder) $ 1,105 $ 64 2024 1,953 17 2025 1,043 — 2026 80 — 2027 — — 2028 — — Total lease payments 4,181 81 Less: imputed interest ( 436 ) ( 3 ) Total lease liabilities $ 3,745 $ 78 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, 2023 and December 31, 2022 were: June 30, December 31, Lease Term and Discount Rate 2023 2022 Weighted average remaining lease term (years) Operating leases 2.07 2.42 Finance leases 0.60 1.29 Weighted average discount rate Operating leases 10.3 % 10.3 % Finance leases 9.4 % 9.5 % |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
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 $ 260,000 as of June 30, 2023 and December 31, 2022. 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, 2023 and December 31, 2022 , 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. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 10 – Subsequent Events June 2023 LSA repayment On August 4, 2023, the Company repaid its outstanding June 2023 LSA of $ 20.0 million early which included outstanding accrued interest of approximately $ 0.2 million, and approximately $ 1.0 million in final payment and other fees. ATM Offering As of the date of this report, a total of 2,617,964 shares of the Company's common stock, for total gross proceeds of $ 50.0 million (net proceeds of $ 47.8 million), have been issued and sold pursuant to the ATM offering, of which 428,000 shares of the Company's common stock, for net proceeds of $ 11.9 million, were sold subsequent to June 30, 2023. |
Summary of Accounting Policies
Summary of Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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, 2022 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 audited consolidated financial statements included in the Company’s 2022 Annual Report on Form 10-K filed with the SEC on March 6, 2023. 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. Operating Segments The Company determined its operating segment on the same basis that it uses to evaluate its performance internally. The Company’s chief operating decision-maker (“CODM”), its Chief Executive Officer, reviews its consolidated operating results for the purpose of allocating resources and evaluating financial performance. The Company determined that it operates and manages its business (including its non-U.S. subsidiaries) in one reportable segment: the research and development, manufacture and sale of light adjustable lenses and related capital equipment. |
Liquidity and Financial Position | Liquidity Shelf Registration Statement On August 8, 2022, the Company filed a $ 200.0 million shelf registration statement on Form S-3 (“shelf registration statement”) which became effective on August 12, 2022. The shelf registration statement is effective for three years and permits the Company to sell, from time to time, up to $ 200.0 million in aggregate value of common stock, preferred stock, debt securities, warrants, and/or units. The shelf registration statement is intended to provide the Company with flexibility to access additional capital. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement to sell up to an aggregate value of $ 50.0 million dollars of common stock through an “at-the-market” (“ATM”) offering. ATM Offering As of June 30, 2023, through the ATM offering, a total of 2,189,964 shares of the Company's common stock, for total net proceeds of $ 35.8 million, have been issued and sold, of which 1,714,089 shares of the Company's common stock, for net proceeds of $ 29.9 million, were sold during the six months ended June 30, 2023. Public Offering On February 7, 2023 , the Company entered into an underwriting agreement with BofA Securities, Inc., in which the Company agreed to issue and sell 4,000,000 shares of the Company's common stock in a public offering (“Public Offering”), pursuant to the shelf registration statement. The shares of common stock were sold at a price to the public of $ 12.50 per share. Under the terms of the underwriting agreement, the Company also granted the underwriters an option exercisable for 30 days from the date of the underwriting agreement to purchase up to an additional 600,000 shares of common stock on the same terms and conditions. The underwriters' option was exercised in full on February 10, 2023 and closed on February 14, 2023. The Company received net proceeds of approximately $ 53.6 million from the Public Offering, after deducting underwriters' discounts and commissions of $ 3.5 million and offering expenses of $ 0.5 million. As of June 30, 2023 and December 31, 2022 the Company had cash, cash equivalents and short-term investments of $ 147.1 million and $ 105.8 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, 2023 and 2022, the Company incurred losses from operations of $ 13.6 million and $ 15.8 million, respectively. For the six months ended June 30, 2023 and 2022, the Company incurred losses from operations of $ 26.7 million and $ 32.4 million, respectively. Based on the Company’s anticipated sales growth in relation to the anticipated costs associated with, among other things, its continuing research and development activities and the 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, 2023 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, 2023 , 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 6, 2023. |
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 $ 57,000 and $ 75,000 of unrealized losses related to short-term investments as of June 30, 2023 and December 31, 2022 , 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. A portion of the Company's operating cash is held in accounts in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limits; however, 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 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, 2023 and December 31, 2022 the Company did not have any customers who individually accounted for greater 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, 2023 or December 31, 2022 . |
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. 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. 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. Cash, cash equivalents, accounts receivable and accounts payable are carried at their estimated fair value because of the short-term nature of these assets and liabilities. The Company’s short-term investments in government securities are carried at fair value, determined based on publicly available quoted market prices for identical securities at the measurement date. The Company believes the fair values of its operating lease liabilities, new loan and security agreement and amended term loan at June 30, 2023 and December 31, 2022 approximated their carrying values, based on the borrowing rates that were available for loans with similar terms as of such date. |
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 Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average shares of common stock outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average shares of common stock and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock and potential dilutive securities outstanding during the period. 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 was anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 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 5,821,076 1,942,092 3,409,842 1,973,913 Restricted stock units issued under the 2021 Equity Incentive Plan 773,940 65,825 671,956 48,188 Stock issuable in offering period under the 2021 Employee Stock Purchase Plan 39,568 48,373 45,191 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: (i) LDD capital asset and related components, (ii) training and (iii) 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 generally 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, 2023 and 2022, credits related to returns and rebates on list prices were not significant. The Company has 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. Revenue for service agreements is recognized ratably over the term of each contract. For the three and six months ended June 30, 2023 and 2022, contract liabilities from sales activity recorded as liabilities on the Company's condensed consolidated balance sheets consisted of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 LDD (including training) $ 7,720 $ 5,683 $ 14,195 $ 10,253 LAL 12,411 5,349 22,806 9,453 Service warranty, service contracts, and accessories 679 328 1,298 595 $ 20,810 $ 11,360 $ 38,299 $ 20,301 As of June 30, 2023 and December 31, 2022, the Company recognized contract liabilities on its condensed consolidated balance sheets of $ 1,351,000 and $ 1,187,000, 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, 2023 and 2022, respectively (in thousands): Six Months Ended June 30, 2023 2022 Balance at beginning of period $ 1,193 $ 540 Additions during the period 1,391 741 Revenue recognized during the period ( 1,233 ) ( 543 ) Balance at end of period $ 1,351 $ 738 For the three and six months ended June 30, 2023 and 2022 , the Company did not have any customers who individually accounted for greater than 10 % of revenue. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company has three equity 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 of directors of the Company (the “Board”) and consultants and provide them with an incentive to promote the Company’s success and accomplish corporate goals. Stock option awards are 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: (i) one fourth of the total number of shares vest and become exercisable on the one-year anniversary and then 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; or (ii) 1/48th of the total number of shares subject to the option vest and become exercisable each month over four 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 Board at the time of each option grant by considering a number of objective and subjective factors. These factors included the valuation of a select group of public peer group companies within the medical device industry that focus on technological advances and development that the Board believed were comparable to the Company’s operations. Operating and financial performance, the lack of liquidity of the common stock and trends in the broader economy and medical device industry also impacted the determination of the fair value of the common stock. In addition, the Company regularly engaged a third-party valuation specialist to assist with estimates related to the valuation of the Company’s common stock. For all grants subsequent to commencement of trading of the Company's shares on the Nasdaq Global Market in July 2021, the fair value of common stock was determined by using the closing price per share of 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. The Black-Scholes option-pricing model requires the use of assumptions about a number of variables, such as the fair market value of the Company’s common stock, expected term, expected volatility, the risk-free interest rate, and dividend yield as discussed below. 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 initial public offering (“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. 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”). There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended June 30, 2023 that are of significance or potential significance to the Company. |
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. |
Summary of Accounting Policie_2
Summary of Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Dilutive Securities Excluded from Computation of Loss Per Share | 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 was anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 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 5,821,076 1,942,092 3,409,842 1,973,913 Restricted stock units issued under the 2021 Equity Incentive Plan 773,940 65,825 671,956 48,188 Stock issuable in offering period under the 2021 Employee Stock Purchase Plan 39,568 48,373 45,191 47,496 |
Schedule of Revenue from Contracts with Customers | For the three and six months ended June 30, 2023 and 2022, contract liabilities from sales activity recorded as liabilities on the Company's condensed consolidated balance sheets consisted of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 LDD (including training) $ 7,720 $ 5,683 $ 14,195 $ 10,253 LAL 12,411 5,349 22,806 9,453 Service warranty, service contracts, and accessories 679 328 1,298 595 $ 20,810 $ 11,360 $ 38,299 $ 20,301 |
Schedule of Deferred Revenue Activity | The following table represents the contract liabilities from sales activity for the six months ended June 30, 2023 and 2022, respectively (in thousands): Six Months Ended June 30, 2023 2022 Balance at beginning of period $ 1,193 $ 540 Additions during the period 1,391 741 Revenue recognized during the period ( 1,233 ) ( 543 ) Balance at end of period $ 1,351 $ 738 |
Short-Term Investment (Tables)
Short-Term Investment (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Short-Term Investments [Abstract] | |
Schedule of Short-term Investments Available For Sale | As of June 30, 2023 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 138,397 $ ( 57 ) $ 138,340 As of December 31, 2022 Amortized Cost Unrealized Loss, Net Estimated Fair Value U.S. Treasury securities $ 94,043 $ ( 75 ) $ 93,968 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consisted of the following (in thousands): June 30, December 31, 2023 2022 Finished goods $ 7,757 $ 6,408 Raw materials 5,719 6,494 Work-in-process 4,868 2,567 18,344 15,469 Less: reserve for excess and obsolete inventory ( 399 ) ( 634 ) $ 17,945 $ 14,835 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 for the periods presented 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. The Company did not have any assets or liabilities measured at fair value on a recurring basis within Level 3 fair value measurements. As of June 30, 2023 Level I Level II Total Assets: Money market securities $ 5,391 $ — $ 5,391 U.S. Treasury securities — 138,340 138,340 Total assets at fair value $ 5,391 $ 138,340 $ 143,731 As of December 31, 2022 Level I Level II Total Assets: Money market securities $ 8,909 $ — $ 8,909 U.S. Treasury securities — 93,968 93,968 Total assets at fair value $ 8,909 $ 93,968 $ 102,877 |
Term Loan (Tables)
Term Loan (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Future Principal Payments Due Under the Term Loan | As of June 30, 2023 future principal payments due under the June 2023 LSA were as follows (in thousands): Year Ended December 31, 2023 (remainder) $ — 2024 — 2025 — 2026 4,348 2027 10,435 2028 5,217 Total 20,000 Less: exit fee and unamortized issuance costs ( 411 ) Term loan, net $ 19,589 See Note 10 - Subsequent Events for further information. |
Schedule of Cash Interest Paid and Effective Interest Rate On Term Loan | For the three and six months ended June 30, 2023 and 2022 the cash interest paid and effective interest rate on the June 2023 LSA and May 2022 Term Loan were as follows: For the Three Months Ended June 30, For the Six Months Ended June 30, 2023 2022 2023 2022 Cash interest paid 14.07 % 9.86 % 13.85 % 9.52 % Effective interest rate 15.48 % 11.50 % 15.25 % 11.05 % |
Stock-Based Compensation Expe_2
Stock-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activities | six months ended June 30, 2023 is presented below: Number of Options Weighted Weighted Avg Options outstanding as of December 31, 2022 6,339,558 $ 11.88 6.48 Granted 1,315,591 15.09 Exercised ( 415,456 ) 8.09 Forfeited ( 88,582 ) 13.26 Expired ( 62,392 ) 18.49 Options outstanding as of June 30, 2023 7,088,719 12.62 6.84 Exercisable as of June 30, 2023 4,016,925 $ 11.24 5.30 As of June 30, 2023 and December 31, 2022 the intrinsic value of options vested was $ 70.5 million and $ 15.9 million, respectively, and of all options outstanding was $ 114.7 million and $ 16.4 million, respectively. During the six months ended June 30, 2023 and 2022 , the total cash received from the exercise of stock options was $ 3.4 million and $ 0.6 million, respectively. The total fair value less strike price of these options was $ 5.2 million and $ 1.2 million, respectively. |
Summary of Non-Vested Restricted stock unit Activities | A summary of non-vested restricted stock unit activities for the six months ended June 30, 2023 is as follows: Weighted Average Number of Grant Date Shares Fair Value Unvested at December 31, 2022 492,862 $ 15.08 Granted 430,926 16.00 Vested ( 144,234 ) 14.43 Forfeited ( 6,105 ) 15.12 Unvested at June 30, 2023 773,449 $ 15.72 |
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, 2023 2022 2023 2022 Research and development $ 1,021 $ 792 $ 1,823 $ 1,566 Selling, general and administrative 2,639 1,866 4,910 3,520 Cost of goods sold 295 246 517 467 $ 3,955 $ 2,904 $ 7,250 $ 5,553 |
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, 2023 2022 Range Weighted Average Range Weighted Average Expected volatility 64.9 % to 65.7 % 65.1 % 62.4 % to 63.4 % 62.7 % Risk-free interest rate 3.4 % to 4.2 % 4.1 % 2.0 % to 3.0 % 2.2 % Expected life (in years) 6.0 to 10.0 years 6.0 years 6.0 to 10.0 years 6.1 years Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Grant date fair value $ 12.91 to $ 28.80 $ 15.26 $ 10.74 to $ 12.85 $ 12.32 |
Schedule of Common stock reserved for future issuance | Each share of common stock is entitled to one vote. Common stock reserved for future issuance under the Equity Plans, 2021 ESPP and the ATM offering consisted of the following: June 30, 2023 December 31, 2022 Stock options issued and outstanding under the Equity Plans 7,088,719 6,339,558 Shares available for future issuance under the Equity Plans 431,050 865,122 Restricted stock units issued under the 2021 Plan 773,449 492,862 Shares available for future issuance under 2021 ESPP 614,472 664,976 Shares available for future sale under the ATM offering (1) 427,892 3,454,064 Total shares of common stock reserved 9,335,582 11,816,582 (1) Based on the closing stock price of $ 28.80 as reported on the Nasdaq Global Market on June 30, 2023 . |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 and December 31, 2022 (in thousands): June 30, December 31, Leases Classification 2023 2022 Assets Operating Operating leases right-of-use assets $ 3,174 $ 3,943 Finance Property and equipment, net 84 206 Total lease assets 3,258 4,149 Liabilities Current Operating Lease liabilities 1,902 1,818 Finance Lease liabilities 78 152 Noncurrent Operating Long-term lease liabilities 1,843 2,813 Finance Long-term lease liabilities — 43 Total lease liabilities $ 3,823 $ 4,826 |
Schedule of Component of Lease Expense | For the three and six months ended June 30, 2023 and 2022, 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 2023 2022 2023 2022 Operating lease cost Cost of sales $ 3 $ 3 $ 7 $ 7 Research and development 24 85 61 159 Selling, general and administrative 438 429 887 833 Finance lease cost Research and development 29 32 63 46 Selling, general and administrative 9 4 18 9 Finance lease cost Interest expense 2 4 7 7 |
Schedule of Maturities of Lease Liabilities | Maturities of the Company’s operating and finance lease liabilities as of June 30, 2023 were as follows (in thousands): Operating Finance Year Ended December 31, Leases Leases 2023 (remainder) $ 1,105 $ 64 2024 1,953 17 2025 1,043 — 2026 80 — 2027 — — 2028 — — Total lease payments 4,181 81 Less: imputed interest ( 436 ) ( 3 ) Total lease liabilities $ 3,745 $ 78 |
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, 2023 and December 31, 2022 were: June 30, December 31, Lease Term and Discount Rate 2023 2022 Weighted average remaining lease term (years) Operating leases 2.07 2.42 Finance leases 0.60 1.29 Weighted average discount rate Operating leases 10.3 % 10.3 % Finance leases 9.4 % 9.5 % |
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 | ||||||
Feb. 07, 2023 USD ($) $ / shares shares | Aug. 12, 2022 USD ($) | Aug. 08, 2022 USD ($) | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) Subsidiary Segment $ / shares shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | |
Subsequent Event [Line Items] | ||||||||
Number of wholly owned subsidiaries | Subsidiary | 1 | |||||||
Number of reportable segment | Segment | 1 | |||||||
Preferred stock, shares outstanding | shares | 0 | 0 | 0 | |||||
Cash, cash equivalents, and short-term investments | $ 147.1 | $ 147.1 | $ 105.8 | |||||
Losses from operations | $ 13.6 | $ 15.8 | $ 26.7 | $ 32.4 | ||||
Common stock, shares authorized | shares | 900,000,000 | 900,000,000 | 900,000,000 | |||||
Common stock par value per share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | shares | 100,000,000 | 100,000,000 | 100,000,000 | |||||
Preferred stock par value per share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Maximum [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Net proceeds from sale of shares | $ 200 | |||||||
IPO [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares sold | shares | 4,000,000 | |||||||
Sale of stock, date | Feb. 07, 2023 | |||||||
Common stock par or stated value per share | $ / shares | $ 12.5 | |||||||
Additional common shares sold | shares | 600,000 | |||||||
Net proceeds from sale of shares | $ 53.6 | |||||||
Common stock sale underwriting discounts and commission deducted | 3.5 | |||||||
Common Stock Offering Costs | $ 0.5 | |||||||
Shelf registration statement [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Net proceeds from sale of shares | $ 200 | |||||||
ATM Offering [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares sold | shares | 2,189,964 | |||||||
Net proceeds from sale of shares | $ 35.8 | |||||||
ATM Offering [Member] | Maximum [Member] | ||||||||
Subsequent Event [Line Items] | ||||||||
Number of shares sold | shares | 1,714,089 | |||||||
Net proceeds from sale of shares | $ 50 | $ 29.9 |
Summary of Accounting Policie_3
Summary of Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Unrealized gain (Loss) on short term investments | $ 57,000 | $ 75,000 | |
Accounts receivable, percentage | 10% | 10% | |
Allowance for doubtful accounts | $ 0 | $ 0 | |
Deferred revenue | $ 1,351,000 | $ 1,187,000 | |
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | No Customer [Member] | |||
Concentration Risk, Percentage | 10% | 10% |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock Options Issued And Outstanding Under Plans | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 5,821,076 | 1,942,092 | 3,409,842 | 1,973,913 |
Restricted Stock Units [Member] | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 773,940 | 65,825 | 671,956 | 48,188 |
Employee Stock Purchase Plan | ||||
Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 39,568 | 48,373 | 45,191 | 47,496 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | $ 20,810 | $ 11,360 | $ 38,299 | $ 20,301 |
L D D | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | 7,720 | 5,683 | 14,195 | 10,253 |
LAL [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | 12,411 | 5,349 | 22,806 | 9,453 |
Service Warranty Service Contracts And Accessories | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from contracts with customers | $ 679 | $ 328 | $ 1,298 | $ 595 |
Summary of Accounting Policie_6
Summary of Accounting Policies - Schedule of Deferred Revenue Activity (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Deferred Revenue [Abstract] | ||
Balance at beginning of period | $ 1,193 | $ 540 |
Additions during the period | 1,391 | 741 |
Recognized during the period | (1,233) | (543) |
Balance at end of period | $ 1,351 | $ 738 |
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, 2023 | Dec. 31, 2022 |
Short Term Debt [Line Items] | ||
Amortized Cost | $ 138,397 | $ 94,043 |
Unrealized Loss, Net | (57) | (75) |
Estimated Fair Value | $ 138,340 | $ 93,968 |
Short-Term Investment - Additio
Short-Term Investment - Additional Information (Details) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
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, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 7,757 | $ 6,408 |
Raw materials | 5,719 | 6,494 |
Work-in-process | 4,868 | 2,567 |
Inventory gross | 18,344 | 15,469 |
Less: reserve for excess and obsolete inventory | (399) | (634) |
Inventory net | $ 17,945 | $ 14,835 |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) $ in Millions | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Inventory held on consignment | $ 5.4 | $ 2.8 |
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, 2023 | Dec. 31, 2022 |
Assets: | ||
Total assets at fair value | $ 143,731 | $ 102,877 |
Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 5,391 | 8,909 |
U.S. Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | 138,340 | 93,968 |
Level I [Member] | ||
Assets: | ||
Total assets at fair value | 5,391 | 8,909 |
Level I [Member] | Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 5,391 | 8,909 |
Level I [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | 0 | 0 |
Level II [Member] | ||
Assets: | ||
Total assets at fair value | 138,340 | 93,968 |
Level II [Member] | Money market Securities [Member] | ||
Assets: | ||
Total assets at fair value | 0 | 0 |
Level II [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Total assets at fair value | $ 138,340 | $ 93,968 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | 10 Months Ended | 12 Months Ended | |||
Nov. 01, 2023 | May 03, 2022 | Jul. 31, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Oct. 31, 2022 | Oct. 31, 2023 | |
Debt Instrument [Line Items] | |||||||
Debt instrument face amount | $ 60,000 | ||||||
Term Loan Description | The May 2022 Term Loan required 35 months of interest-only payments, followed by 22-months of principal and accrued interest payments. If the Company was in compliance with its performance-to-plan covenant through April 1, 2025 and had not provided an IP lien election notice before May 1, 2025, the interest-only period would have been extended by 12 months, and the amortization period would have been reduced to ten months. Payments were due on the first day of each month in arrears. All unpaid amounts under the May 2022 Term Loan were to mature on February 1, 2027. | ||||||
Loan, Description | Under the May 2022 Term Loan, a final payment (“Final Payment”) would have been 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 Company paid $0.1 million in loan amendment fees and other closing costs that are directly attributable to execution of the May 2022 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. | ||||||
Interest rate on borrowings term loan | 5% | 3% | 4% | ||||
Proceeds from issuance of common stock | $ 3,896 | $ 1,044 | |||||
Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Payment of Loan, Partly | 5,000 | ||||||
August Four Two Thousand Twenty Three [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from Lines of Credit | 9,300 | ||||||
Subsequent Event [Member] | ATM Offering [Member] | Common Stock [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of common stock | $ 11,900 | ||||||
Retired Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from Loan Originations | 20,000 | ||||||
Proceeds from Lines of Credit | 19,400 | ||||||
Proceeds from Lines of Credit | 1,700 | ||||||
May 2022 Term Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument face amount | $ 60,000 | ||||||
Interest rate on borrowings term loan | 9.25% | ||||||
Proceeds from Loan Originations | $ 40,000 | $ 10,000 | |||||
Loan, Description of Variable Rates | The May 2022 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 was an event of default under the May 2022 Term Loan additional interest of 5.0% applies. | ||||||
New Loan and Security Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument face amount | $ 20,000 | ||||||
Additional Borrowing Amount | $ 40,000 | ||||||
Interest rate on borrowings term loan | 5% | ||||||
Loan Amendment Fees And Other Closing Costs | $ 100 | ||||||
Loan, Description of Variable Rates | Each Loan bears interest at a floating per annum rate equal to (a) the greater of (i) the 1-Month Term SOFR on the last business day of the month that immediately precedes the month in which the interest will accrue and (ii) 5.15%, plus (b) 6.35%; provided, in no event will the interest rate for any Loan be less than 11.50% per annum. | ||||||
Unused Term Loan Commitment Fee Rate | 1% | ||||||
Loan Maturity Date | Jun. 01, 2028 | ||||||
Repayment Commencement Date | Aug. 01, 2026 | ||||||
Debt Instrument Final Payment Fee Rate | 5% | ||||||
Debt Instrument, Payment Terms | The Loans mature on June 1, 2028. Principal repayment will commence on August 1, 2026 in equal monthly installments of the outstanding Loan balance through the maturity date. If the Company is in compliance with its revenue covenant in the June 2023 LSA for each quarterly measuring date from June 30, 2023 through July 1, 2026 and if it has not elected to pledge its intellectual property as collateral security for the Loans before August 1, 2026, then principal repayment will begin on August 1, 2027 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Debt Disclosure [Abstract] | ||||
Cash Interest Paid | 14.07% | 9.86% | 13.85% | 9.52% |
Effective interest rate | 15.48% | 11.50% | 15.25% | 11.05% |
Term Loan - Future Principal Pa
Term Loan - Future Principal Payments Due Under the Term Loan (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
2023 (remainder) | $ 0 | |
2024 | 0 | |
2025 | 0 | |
2026 | 4,348 | |
2027 | 10,435 | |
2028 | 5,217 | |
Total | 20,000 | |
Less: exit fee and unamortized issuance costs | (411) | |
Term loan, net | $ 19,589 | $ 40,169 |
Common Stock Warrant Liability
Common Stock Warrant Liability - Additional Information (Details) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Class Of Warrant Or Right [Line Items] | ||
Common stock par value per share | $ 0.001 | $ 0.001 |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Deficit - Summary of Preferred Stock (Details) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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, 2023 | Dec. 31, 2022 |
Class Of Stock [Line Items] | ||
Conversion of preferred stock | 9,335,582 | 11,816,582 |
Restricted Stock Units [Member] | ||
Class Of Stock [Line Items] | ||
Conversion of preferred stock | 773,449 | 492,862 |
Stock-Based Compensation Expe_3
Stock-Based Compensation Expense - Additional Information (Details) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended | |||||
Jul. 28, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2023 | Jan. 01, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock shares issued | 35,168,041 | 28,268,389 | |||||
Shares of common stock reserved | 9,335,582 | 11,816,582 | |||||
Total unrecognized expense related to unvested stock options | $ 10.9 | $ 6.1 | |||||
Weighted average period for recognition of expenses | 2 years 8 months 12 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 | $ 70.5 | 15.9 | |||||
Intrinsic Value of Outstanding Options | 114.7 | $ 16.4 | |||||
Total Cash Received from the Exercise of Stock Options | 3.4 | $ 0.6 | |||||
Total Fair Value Less Strike Price of Stock Options Exercised | $ 5.2 | $ 1.2 | |||||
Number of Options, Unvested | 3,071,794 | 2,447,687 | |||||
Weighted average period for recognition of expenses | 7 months 6 days | ||||||
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 shares issued | 7,260,406 | ||||||
Shares of common stock reserved | 431,050 | 1,130,735 | 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 9 months 18 days | 2 years 3 months 18 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 | ||||||
The 2015 Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized expense related to unvested stock options | $ 25.9 | $ 19.1 | |||||
2021 Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock shares issued | 614,472 | ||||||
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% | ||||||
Share-based Compensation, Option [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Stock-Based Compensation, Terms of Award | Stock option awards are 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: (i) 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, or (ii) 1/48th of the total number of shares subject to the option vest and become exercisable each month over four years. | ||||||
Stock-Based Compensation, Vesting period | 4 years | ||||||
Restricted Stock Units (RSUs) [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares of common stock reserved | 773,449 | 492,862 | |||||
Number of Options, Unvested | 773,449 |
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, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Beginning balance | 6,339,558 | |
Number of Options, Granted | 1,315,591 | |
Number of Options, Exercised | (415,456) | |
Number of Options, Forfeited | (88,582) | |
Number of Options, Expired | (62,392) | |
Number of Options, Ending balance | 7,088,719 | 6,339,558 |
Number of Options, Exercisable | 4,016,925 | |
Weighted-Average Exercise Price, Beginning balance | $ 11.88 | |
Weighted-Average Exercise Price, Options Granted | 15.09 | |
Weighted-Average Exercise Price, Options Exercised | 8.09 | |
Weighted-Average Exercise Price, Options Forfeited | 13.26 | |
Weighted-Average Exercise Price, Expired | 18.49 | |
Weighted-Average Exercise Price, Ending balance | 12.62 | $ 11.88 |
Weighted-Average Exercise Price, Exercisable | $ 11.24 | |
Weighted-Average Remaining Contractual Term (Years), Options outstanding | 6 years 10 months 2 days | 6 years 5 months 23 days |
Weighted-Average Remaining Contractual Term (Years), Exercisable | 5 years 3 months 18 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, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unvested at December 31, 2021 | shares | 492,862 |
Number of Options, Granted | shares | 430,926 |
Number of shares, vested | shares | (144,234) |
Number of shares, forfeited | shares | (6,105) |
Unvested at September 30, 2022 | shares | 773,449 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 15.08 |
Weighted Average Grant Date Fair Value, Options Granted | $ / shares | 16 |
Weighted average fair value, vested | $ / shares | 14.43 |
Weighted average fair value, forfeited | $ / shares | 15.12 |
Weighted average fair value, Ending Balance | $ / shares | $ 15.72 |
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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 3,955 | $ 2,904 | $ 7,250 | $ 5,553 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 1,021 | 792 | 1,823 | 1,566 |
Selling, General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 2,639 | 1,866 | 4,910 | 3,520 |
Cost of Goods Sold | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 295 | $ 246 | $ 517 | $ 467 |
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, 2023 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected volatility, Weighted Average | 65.10% | 62.70% |
Risk-free interest rate, Weighted Average | 4.10% | 2.20% |
Expected life (in years), Weighted Average | 6 years | 6 years 1 month 6 days |
Expected dividend yield, Weighted Average | 0% | 0% |
Grant date fair value, Weighted Average | $ 15.26 | $ 12.32 |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, Minimum | 65.70% | |
Expected volatility, Maximum | 63.40% | |
Risk-free interest rate, Minimum | 4.20% | |
Risk-free interest rate, Maximum | 3% | |
Expected life (in years) | 10 years | 10 years |
Grant date fair value | $ 28.8 | $ 12.85 |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, Minimum | 64.90% | 62.40% |
Risk-free interest rate, Minimum | 3.40% | 2% |
Expected life (in years) | 6 years | 6 years |
Grant date fair value | $ 12.91 | $ 10.74 |
Stock-Based Compensation Expe_8
Stock-Based Compensation Expense - Common stock reserved for future issuance (Details) - shares | Jun. 30, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | 9,335,582 | 11,816,582 | |
Future [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | [1] | 427,892 | 3,454,064 |
Restricted Stock Units | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | 773,449 | 492,862 | |
Stock options issued and outstanding under the 2006, 2015 and 2021 plans | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | 7,088,719 | 6,339,558 | |
Shares Available For Future Issuance Under The 2006 ,2015 And 2021 Plans [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | 431,050 | 865,122 | |
The 2021 ESPP Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares of common stock reserved | 614,472 | 664,976 | |
[1] Based on the closing stock price of $ 28.80 as reported on the Nasdaq Global Market on June 30, 2023 . |
Stock-Based Compensation Expe_9
Stock-Based Compensation Expense - Common stock reserved for future issuance (Parenthetical) (Details) | Jun. 30, 2023 $ / shares |
Share-Based Payment Arrangement [Abstract] | |
Stock price | $ 28.8 |
Stockholders' Equity (Additiona
Stockholders' Equity (Additional Information) (Details) - $ / shares | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||||||
Common stock, authorized (in shares) | 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 shares issued | 35,168,041 | 28,268,389 | ||||
Common stock outstanding (in shares) | 35,168,041 | 28,268,389 | ||||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock outstanding (in shares) | 35,168,041 | 33,966,697 | 28,268,389 | 27,631,479 | 27,485,685 | 27,366,746 |
Leases - Additional Information
Leases - Additional Information (Details) | 6 Months Ended | ||
Apr. 01, 2023 USD ($) | Apr. 04, 2022 USD ($) | Jun. 30, 2023 USD ($) ft² Item | |
Lessee Lease Description [Line Items] | |||
Lease expiration date | Mar. 31, 2025 | ||
Sublease agreement | 34 months | ||
Lease Rent Payable | $ 11,410 | ||
Operating Leases, Rent Expense, Sublease Rentals | $ 5,319 | ||
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, 2023 | Dec. 31, 2022 |
Assets | ||
Operating leases right-of-use assets | $ 3,174 | $ 3,943 |
Assets Finance | $ 84 | $ 206 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property and equipment, net | Property and equipment, net |
Total lease assets | $ 3,258 | $ 4,149 |
Current liabilities: | ||
Liabilities Current Operating | $ 1,902 | $ 1,818 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease liabilities | Lease liabilities |
Liabilities Current Finance | $ 78 | $ 152 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease liabilities | Lease liabilities |
Noncurrent | ||
Liabilities Noncurrent Operating | $ 1,843 | $ 2,813 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease liabilities | Long-term lease liabilities |
Liabilities Noncurrent Finance | $ 0 | $ 43 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Long-term lease liabilities | Long-term lease liabilities |
Total lease liabilities | $ 3,823 | $ 4,826 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Lessee Lease Description [Line Items] | ||||
Finance lease cost | $ 2 | $ 4 | $ 7 | $ 7 |
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 | 24 | 85 | 61 | 159 |
Finance lease cost | 29 | 32 | 63 | 46 |
Selling, General and Administrative | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease cost | 438 | 429 | 887 | 833 |
Finance lease cost | $ 9 | $ 4 | $ 18 | $ 9 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilites (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Operating Leases | |
2023 (remainder) | $ 1,105 |
2024 | 1,953 |
2025 | 1,043 |
2026 | 80 |
2027 | 0 |
2028 | 0 |
Total lease payments | 4,181 |
Less: imputed interest | (436) |
Total lease liabilities | 3,745 |
Finance Leases | |
2023 (remainder) | 64 |
2024 | 17 |
2025 | 0 |
2026 | 0 |
2027 | 0 |
2028 | 0 |
Total lease payments | 81 |
Less: imputed interest | (3) |
Total lease liabilities | $ 78 |
Leases - Summary of Weighted Av
Leases - Summary of Weighted Average Remaining Lease Term and Discount Rate (Details) | Jun. 30, 2023 | Dec. 31, 2022 |
Weigted average remaining lease term (years) | ||
Weighted average remaining lease term - operating leases | 2 years 25 days | 2 years 5 months 1 day |
Weighted average remaining lease term - finance leases | 7 months 6 days | 1 year 3 months 14 days |
Weighted average discount rate | ||
Weighted average discount rate - operating leases (as a percent) | 10.30% | 10.30% |
Weighted average discount rate - finance leases (as a percent) | 9.40% | 9.50% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
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 | $ 260,000 | $ 260,000 |
Subsequent Event (Additional In
Subsequent Event (Additional Information) (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | ||
Aug. 04, 2023 | Jul. 31, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | |
Subsequent Event [Line Items] | ||||
Proceeds from issuance of common stock | $ 3,896 | $ 1,044 | ||
ATM Offering [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued and sold | 2,189,964 | |||
ATM Offering [Member] | Common Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued and sold | 2,617,964 | |||
Proceeds from issuance of common stock | $ 50,000 | |||
Net proceeds from issuance of common stock | $ 47,800 | |||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Repayment of outstanding debt | $ 20,000 | |||
Accrued interest paid | 200 | |||
Final payment and other fees | $ 1,000 | |||
Subsequent Event | ATM Offering [Member] | Common Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued and sold | 428,000 | |||
Proceeds from issuance of common stock | $ 11,900 |