Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | Treace Medical Concepts, Inc. | |
Entity File Number | 001-40355 | |
Entity Tax Identification Number | 47-1052611 | |
Entity Address, Address Line One | 100 Palmetto Park Place | |
Entity Address, City or Town | Ponte Vedra | |
Entity Address, Postal Zip Code | 32081 | |
City Area Code | 904 | |
Local Phone Number | 373-5940 | |
Entity Central Index Key | 0001630627 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, State or Province | FL | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Title of 12(b) Security | Common stock, $0.001 par value | |
Trading Symbol | TMCI | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 55,501,742 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 88,546 | $ 105,833 |
Accounts receivable | 18,548 | 18,568 |
Inventories | 16,794 | 10,561 |
Prepaid expenses and other current assets | 4,014 | 3,010 |
Total current assets | 127,902 | 137,972 |
Property and equipment, net | 14,148 | 2,849 |
Operating lease right-of-use assets | 14,247 | 0 |
Other Assets, Noncurrent | 146 | 0 |
Total assets | 156,443 | 140,821 |
Current liabilities | ||
Accounts payable | 7,881 | 4,056 |
Accrued liabilities | 5,189 | 4,518 |
Accrued commissions | 4,131 | 5,181 |
Accrued compensation | 5,049 | 4,455 |
Operating lease liabilities | 330 | 0 |
Total current liabilities | 22,580 | 18,210 |
Derivative liability on term loan | 0 | 173 |
Long-term debt | 52,636 | 29,365 |
Noncurrent portion of lease liability | 19,026 | 0 |
Total liabilities | 94,242 | 47,748 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity | ||
Preferred stock, value | 0 | 0 |
Common stock, value | 46 | 45 |
Additional paid-in capital | 142,463 | 134,933 |
Accumulated deficit | (80,308) | (41,905) |
Total stockholders’ equity | 62,201 | 93,073 |
Total liabilities and stockholders’ equity | $ 156,443 | $ 140,821 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Allowance for doubtful accounts receivable current | $ 423 | $ 414 |
Long term debt unamortized debt discount and issuance costs | $ 1,364 | $ 635 |
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par or stated value per share | $ 0.001 | $ 0.001 |
Common stock shares authorized | 300,000,000 | 300,000,000 |
Common stock share issued | 55,499,242 | 54,181,082 |
Common stock share outstanding | 55,499,242 | 54,181,082 |
Condensed Statement of Operatio
Condensed Statement of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenue | $ 33,055 | $ 21,619 | $ 92,069 | $ 60,980 |
Cost of goods sold | 6,624 | 4,248 | 17,781 | 11,519 |
Gross profit | 26,431 | 17,371 | 74,288 | 49,461 |
Operating expenses | ||||
Sales and marketing | 25,034 | 15,984 | 73,207 | 42,142 |
Research and development | 3,799 | 2,537 | 9,835 | 6,827 |
General and administrative | 8,916 | 4,310 | 22,593 | 11,405 |
Total operating expenses | 37,749 | 22,831 | 105,635 | 60,374 |
Loss from operations | (11,318) | (5,460) | (31,347) | (10,913) |
Interest and other income, net | 375 | 5 | 514 | 12 |
Interest expense | (1,190) | (963) | (3,087) | (3,032) |
Debt extinguishment loss | 0 | 0 | (4,483) | 0 |
Other expense, net | (815) | (958) | (7,056) | (3,020) |
Net loss and comprehensive loss | (12,133) | (6,418) | (38,403) | (13,933) |
Convertible preferred stock cumulative and undeclared dividends | 0 | 0 | 0 | (196) |
Net loss attributable to common stockholders | $ (12,133) | $ (6,418) | $ (38,403) | $ (14,129) |
Net loss per share attributable to common stockholders, basic | $ (0.22) | $ (0.12) | $ (0.70) | $ (0.30) |
Net loss per share attributable to common stockholders, diluted | $ (0.22) | $ (0.12) | $ (0.70) | $ (0.30) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic | 55,429,211 | 52,766,150 | 55,190,587 | 46,603,487 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted | 55,429,211 | 52,766,150 | 55,190,587 | 46,603,487 |
Condensed Statement of Stockhol
Condensed Statement of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series A Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Balance at Beginning at Dec. 31, 2020 | $ 776 | $ 7,935 | $ 28 | $ 14,166 | $ (21,353) |
Balance at Beginning (in Shares) at Dec. 31, 2020 | 6,687,475 | 37,366,865 | |||
Issuance of common stock upon exercise of stock options | 570 | $ 2 | 568 | ||
Issuance of common stock upon exercise of stock options, shares | 690,551 | ||||
Share-based compensation expense | 402 | 402 | |||
Net loss | (2,432) | (2,432) | |||
Balance at Ending at Mar. 31, 2021 | (684) | $ 7,935 | $ 30 | 15,136 | (23,785) |
Balance at Ending (in Shares) at Mar. 31, 2021 | 6,687,475 | 38,057,416 | |||
Balance at Beginning at Dec. 31, 2020 | 776 | $ 7,935 | $ 28 | 14,166 | (21,353) |
Balance at Beginning (in Shares) at Dec. 31, 2020 | 6,687,475 | 37,366,865 | |||
Net loss | (13,933) | ||||
Balance at Ending at Sep. 30, 2021 | 97,373 | $ 45 | 132,614 | (35,286) | |
Balance at Ending (in Shares) at Sep. 30, 2021 | 52,755,981 | ||||
Balance at Beginning at Mar. 31, 2021 | (684) | $ 7,935 | $ 30 | 15,136 | (23,785) |
Balance at Beginning (in Shares) at Mar. 31, 2021 | 6,687,475 | 38,057,416 | |||
Issuance of common stock upon exercise of stock options | 193 | 193 | |||
Issuance of common stock upon exercise of stock options, shares | 272,082 | ||||
Vesting of restricted stock awards, shares | 5,866 | ||||
Share-based compensation expense | 875 | 875 | |||
Issuance of common stock from initial public offering, net of issuance costs and underwriting discount of $10.6 million, shares | 6,953,125 | ||||
Issuance of common stock from initial public offering, net of issuance costs and underwriting discount of $10.6 million | 107,610 | $ 7 | 107,603 | ||
Issuance of common stock upon net exercise of warrants, shares | 621,570 | ||||
Issuance of common stock upon net exercise of warrants | $ 1 | (1) | |||
Conversion of convertible preferred stock and accrued dividends on convertible preferred stock into common stock, shares | (6,687,475) | 6,845,922 | |||
Conversion of convertible preferred stock and accrued dividends on convertible preferred stock into common stock | $ (7,935) | $ 7 | 7,928 | ||
Net loss | (5,083) | (5,083) | |||
Balance at Ending at Jun. 30, 2021 | 102,911 | $ 45 | 131,734 | (28,868) | |
Balance at Ending (in Shares) at Jun. 30, 2021 | 52,755,981 | ||||
Issuance of common stock upon exercise of stock options | 41 | 41 | |||
Share-based compensation expense | 839 | 839 | |||
Net loss | (6,418) | (6,418) | |||
Balance at Ending at Sep. 30, 2021 | 97,373 | $ 45 | 132,614 | (35,286) | |
Balance at Ending (in Shares) at Sep. 30, 2021 | 52,755,981 | ||||
Balance at Beginning at Dec. 31, 2021 | 93,073 | $ 45 | 134,933 | (41,905) | |
Balance at Beginning (in Shares) at Dec. 31, 2021 | 54,181,082 | ||||
Issuance of common stock upon exercise of stock options | 1,372 | $ 1 | 1,371 | ||
Issuance of common stock upon exercise of stock options, shares | 1,097,860 | ||||
Share-based compensation expense | 1,409 | 1,409 | |||
Net loss | (9,036) | (9,036) | |||
Balance at Ending at Mar. 31, 2022 | 86,818 | $ 46 | 137,713 | (50,941) | |
Balance at Ending (in Shares) at Mar. 31, 2022 | 55,278,942 | ||||
Balance at Beginning at Dec. 31, 2021 | 93,073 | $ 45 | 134,933 | (41,905) | |
Balance at Beginning (in Shares) at Dec. 31, 2021 | 54,181,082 | ||||
Net loss | (38,403) | ||||
Balance at Ending at Sep. 30, 2022 | 62,201 | $ 46 | 142,463 | (80,308) | |
Balance at Ending (in Shares) at Sep. 30, 2022 | 55,499,242 | ||||
Balance at Beginning at Mar. 31, 2022 | 86,818 | $ 46 | 137,713 | (50,941) | |
Balance at Beginning (in Shares) at Mar. 31, 2022 | 55,278,942 | ||||
Issuance of common stock upon exercise of stock options | 165 | 165 | |||
Issuance of common stock upon exercise of stock options, shares | 112,367 | ||||
Share-based compensation expense | 1,963 | 1,963 | |||
Net loss | (17,234) | (17,234) | |||
Balance at Ending at Jun. 30, 2022 | 71,712 | $ 46 | 139,841 | (68,175) | |
Balance at Ending (in Shares) at Jun. 30, 2022 | 55,391,309 | ||||
Issuance of common stock upon exercise of stock options | 353 | 353 | |||
Issuance of common stock upon exercise of stock options, shares | 107,933 | ||||
Share-based compensation expense | 2,269 | 2,269 | |||
Net loss | (12,133) | (12,133) | |||
Balance at Ending at Sep. 30, 2022 | $ 62,201 | $ 46 | $ 142,463 | $ (80,308) | |
Balance at Ending (in Shares) at Sep. 30, 2022 | 55,499,242 |
Condensed Statement of Stockh_2
Condensed Statement of Stockholders' Equity (Deficit) (Parenthetical) $ in Millions | 3 Months Ended |
Jun. 30, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance cost and underwriting discount | $ 10.6 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (38,403) | $ (13,933) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization expense | 1,216 | 409 |
Recovery for allowance for doubtful accounts | (38) | (56) |
Share-based compensation expense | 5,641 | 2,116 |
Non-Cash Lease Expense | 2,010 | |
Amortization of debt issuance costs | 169 | 133 |
(Recovery) Provision of inventory obsolescence | (206) | 179 |
Gain on fair value adjustment to derivative liability | (173) | (72) |
Debt extinguishment loss | 4,483 | 0 |
Other, net | 25 | 0 |
Net changes in operating assets and liabilities: | ||
Accounts Receivable | 58 | 2,747 |
Inventory | (6,027) | (2,710) |
Prepaid expenses and other assets | (1,058) | (3,168) |
Other non-current assets | (146) | 0 |
Operating lease liabilities | 3,112 | 0 |
Accounts payable | 3,825 | 177 |
Accrued liabilities | 222 | 737 |
Net cash used in operating activities | (25,290) | (13,441) |
Cash flows from investing activities | ||
Purchases of property and equipment | (12,506) | (1,805) |
Net cash used in investing activities | (12,506) | (1,805) |
Cash flows from financing activities | ||
Repayment of PPP loan | 0 | (1,788) |
Proceeds from interest bearing term debt | 49,651 | 0 |
Proceeds from interest bearing revolving debt | 3,850 | 0 |
Debt issuance costs paid to third parties | (989) | 0 |
Repayment of term loan | (33,893) | 0 |
Proceeds from issuance of common stock upon initial public offering, net of issuance costs and underwriting fees of $10.6 million | 0 | 107,610 |
Proceeds from exercise of employee stock options | 1,890 | 804 |
Net cash provided by financing activities | 20,509 | 106,626 |
Net (decrease) increase in cash and cash equivalents | (17,287) | 91,380 |
Cash and cash equivalents at beginning of period | 105,833 | 18,079 |
Cash and cash equivalents at end of period | 88,546 | 109,459 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 3,087 | 2,917 |
Operating lease right-of-use assets obtained in exchange for new lease liabilities | 15,300 | 0 |
Supplemental disclosure of noncash investing and financing activities: | ||
Issuance of common stock upon exercise of warrants | 1 | |
Conversion of convertible preferred stock and accrued dividends on convertible preferred stock into common stock | $ 7,935 |
Condensed Statements of Cash _2
Condensed Statements of Cash Flows (Parenthetical) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Statement of Cash Flows [Abstract] | |
Issuance costs and underwriting fees, net | $ 10.6 |
Formation and Business of the C
Formation and Business of the Company | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Formation and Business of the Company | 1. Formation and Business of the Company The Company Treace Medical Concepts, LLC was formed on July 29, 2013 as a Florida limited liability company. Effective July 1, 2014, the entity converted to a Delaware corporation and changed its name to Treace Medical Concepts, Inc. (the “Company”). The Company is a medical technology company driving a fundamental shift in the surgical treatment of Hallux Valgus (commonly known as “bunions”). The Company received 510(k) clearance for the Lapiplasty® System in March 2015 and began selling its surgical medical devices in September 2015. The Company has pioneered the proprietary Lapiplasty 3D Bunion Correction System – a combination of innovative instruments, implants and surgical methods designed to improve the inconsistent clinical outcomes of traditional approaches to bunion surgery. In addition, the Company offers other advanced instrumentation and implants for use in the Lapiplasty Procedure or other ancillary procedures performed in high frequency with bunion surgery. The Company expanded its offerings with the Adductoplasty Midfoot Correction System, designed for reproducible correction of the midfoot to provide further support to hallux valgus patients. The Company operates from its corporate headquarters located in Ponte Vedra, Florida. Initial Public Offering On April 27, 2021, the Company completed its initial public offering (“IPO”) of 12,937,500 shares of its common stock, which included the exercise in full of the underwriters’ option to purchase additional shares. As part of the IPO, 6,953,125 shares of common stock were issued and sold by the Company (inclusive of 703,125 shares pursuant to the exercise of the underwriters’ option) and 5,984,375 shares of common stock that were sold by the selling stockholders named in the prospectus (inclusive of 984,375 shares pursuant to the exercise of the underwriters’ option), at a price to the public of $ 17.00 per share. The Company received net proceeds of approximately $ 107.6 million, after deducting underwriting discounts and commissions of $ 8.3 million and offering expenses payable by the Company of $ 2.3 million. The Company did no t receive any proceeds from the sale of the shares by the selling stockholders. Upon the completion of the IPO, all 6,687,475 shares of Series A convertible preferred stock then outstanding were converted into shares of common stock on a one-to-one basis plus 158,447 shares of common stock were issued to pay accrued cumulative dividends on Series A convertible preferred stock of $ 2.5 million . Liquidity and Capital Resources The Company has incurred operating losses to date and has an accumulated deficit of $ 80.3 million as of September 30, 2022. During the nine months ended September 30, 2022 and 2021 , the Company used $ 25.3 million and $ 13.4 million of cash in its operating activities, respectively. As of September 30, 2022, the Company had cash and cash equivalents of $ 88.5 million. Management believes that the Company’s existing cash and cash equivalents will allow the Company to continue its planned operations for at least the next 12 months from the date of the issuance of these interim condensed financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company prepared the unaudited interim condensed financial statements included in this report in accordance with U.S. generally accepted accounting principles ("GAAP") for interim financial information and the rules and regulations of the Securities and Exchange Commission related to quarterly reports on Form 10-Q. Basis of Presentation The condensed financial statements have been prepared on the same basis as the Company’s annual financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 4, 2022. The unaudited condensed financial statements included herein reflect all adjustments, including normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. The results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for future quarters or for the fiscal year ending December 31, 2022. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC” ) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting periods. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Significant estimates and assumptions include reserves and write-downs related to accounts receivable, inventories, the recoverability of long-term assets, valuation of equity instruments, valuation of common stock, stock-based compensation, deferred tax assets and related valuation allowances and impact of contingencies. The Company had no accrued contingent liabilities as of September 30, 2022 and December 31, 2021 . Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of risk consist principally of cash, cash equivalents and accounts receivable. The Company maintains its cash and cash equivalents balances with established financial institutions and, at times, such balances with any one financial institution may be in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits. The Company earns revenue from the sale of its products to customers such as hospitals and ambulatory surgery centers. The Company’s accounts receivable is derived from revenue earned from customers. The Company performs ongoing credit evaluations of its customers’ financial condition. At September 30, 2022 and December 31, 2021 , no customer accounted for more than 10 % of accounts receivable. For the nine months ended September 30, 2022 and 2021 , there were no customers that represented 10 % or more of revenue. Leases The Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease is classified as a financing lease or operating lease at the commencement date of the lease. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The Company determines the commencement date of a lease to be the date on which a lessor makes an underlying asset available for use by the Company. Leases with a term greater than one year are recognized on the balance sheet as operating lease right-of-use assets, operating lease liabilities and operating lease liabilities, net of current portion. The Company elected not to recognize right-of-use assets and lease liabilities for leases with terms of 12 months or less (short-term leases). As the interest rates implicit in our lease contracts are not readily determinable, the Company utilizes its incremental borrowing rate based on the information available at the commencement date to determine the present value of lease payments. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid, incentives received, or impairment charges if the Company determines the right-of-use asset is impaired. The Company considers the lease term to be the noncancelable period that the Company has the right to use the underlying asset, together with any periods where it is reasonably certain the Company will exercise an option to extend (or not terminate) the lease. Rent expense for operating leases is recognized on a straight-line basis over the lease term and is presented in operating expenses on the statements of operations and comprehensive loss. The Company has elected to not separate lease and non-lease components for its real estate leases and instead accounts for each separate lease component and the non-lease components associated with that lease component as a single lease component. Variable lease payments are recognized as lease expense as incurred and are recorded in operating expenses on the statements of operations and comprehensive loss. The Company has no finance leases. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses . This guidance will require financial instruments measured at amortized cost, and trade accounts receivable to be presented at the net amount expected to be collected. The model requires an entity to estimate credit losses based on historical information, current conditions and reasonable and supportable forecasts of future economic conditions. In November 2019, the FASB issued ASU 2019-10, which provides that this standard is effective for the Company for fiscal years beginning after December 15, 2022, and interim periods within that fiscal year. The Company is currently evaluating the impact of this standard on its financial statements. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (“ASC 842”) . The update establishes principles for recognition, measurement, presentation, and disclosure intended to increase transparency and comparability for the accounting of lease transactions. The standard requires lessees to recognize leases with terms greater than 12 months on the balance sheet and disclose key information about leasing arrangements. ASC 842 is effective for the Company for fiscal years beginning after December 15, 2021 and early application is permitted. The Company adopted the new standard as of January 1, 2022, using the required modified retrospective approach. Comparative periods were not adjusted and continue to be presented under the previous accounting guidance. The Company elected the package of practical expedients permitted under the ASC 842 transition guidance, which among other things, allowed it to carry forward the historical lease classification. The impact of adoption was the recognition of right-of-use assets and lease liabilities of $ 1.9 million for real estate operating leases at January 1, 2022. In addition, ASC 842 requires new disclosures for lease transactions. Refer to Note 8, “Operating Leases”, for new lease disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements Assets and liabilities recorded at fair value in the condensed financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels which are directly related to the amount of subjectivity associated with the inputs to the valuation of these assets or liabilities are as follows: Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date. Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Level 3—Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date. This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Assets and Liabilities Measured and Recorded at Fair Value on a Recurring Basis – The following assets and liabilities are measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021: September 30, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 85,839 $ — $ — $ 85,839 Total $ 85,839 $ — $ — $ 85,839 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 105,220 $ — $ — $ 105,220 Total $ 105,220 $ — $ — $ 105,220 Liabilities: Derivative liability $ — $ — $ 173 $ 173 Total $ — $ — $ 173 $ 173 (1) Money market funds are included in cash and cash equivalents in the condensed balance sheets as of September 30, 2022 and December 31, 2021 . On April 29, 2022, in connection with the refinancing of its long-term debt, the Company repaid the outstanding principal and interest under its term loan facility with CRG Group LP (“CRG”) which also extinguished the embedded derivative liability. The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands): Derivative liability Fair value as of January 1, 2022 $ 173 Change in fair value included in other expense, net ( 173 ) Fair value as of September 30, 2022 $ — There were no assets or liabilities measured at fair value on a nonrecurring basis as of September 30, 2022 and December 31, 2021 . |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 5. Balance Sheet Components Cash and Cash Equivalents The Company’s cash and cash equivalents consisted of the following (in thousands): September 30, December 31, 2022 2021 Cash $ 2,707 $ 613 Cash equivalents: Money market funds 85,839 105,220 Total cash and cash equivalents $ 88,546 $ 105,833 Included in cash as of September 30, 2022 is $ 0.9 million pledged to Silicon Valley Bank (“SVB”) as collateral for the Company's corporate credit card program and is restricted from use by the Company. There was no cash pledged to SVB as of December 31, 2021 . In the fourth quarter of 2022, the Company sold $ 65.0 million of money market funds and will invest the proceeds in various investments that are classified as either cash equivalents or available-for-sale marketable securities. Property and equipment, net The Company’s property and equipment, net consisted of the following (in thousands): September 30, December 31, 2022 2021 Furniture and fixtures, and equipment $ 1,443 $ 180 Construction in progress 723 126 Machinery and equipment 768 274 Capitalized surgical equipment 7,950 4,442 Computer equipment 426 160 Leasehold improvements 6,231 268 Software 138 138 Total property and equipment 17,679 5,588 Less: accumulated depreciation and amortization ( 3,531 ) ( 2,739 ) Property and equipment, net $ 14,148 $ 2,849 Depreciation and amortization expense on property and equipment was $ 0.4 million and $ 0.2 million for the three months ended September 30, 2022 and 2021, respectively. Depreciation and amortization expense on property and equipment was $ 1.2 million and $ 0.4 million for the nine months ended September 30, 2022 and 2021, respectively. Accrued liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, 2022 2021 Accrued royalty expense $ 1,659 $ 1,522 Accrued interest 381 975 Accrued professional services 1,027 941 Other accrued expense 2,122 1,080 Total accrued liabilities $ 5,189 $ 4,518 |
Long Term Debt
Long Term Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Long Term Debt | 6. Long-Term Debt The Company’s long-term debt consisted of the following (in thousands): September 30, December 31, 2022 2021 Revolving line of credit MidCap revolving credit facility $ 4,000 $ — Term loans CRG term loan facility — 30,000 MidCap term loan facility 50,000 — Total term and revolving loans 54,000 30,000 Less: debt discount and issuance costs ( 1,364 ) ( 635 ) Total long-term debt, net $ 52,636 $ 29,365 As of September 30, 2022, future payments of long-term debt were as follows (in thousands): Fiscal Year 2022 (remaining six months) $ — 2023 — 2024 — 2025 — 2026 33,333 2027 20,667 Total principal payments 54,000 Less: Unamortized debt discount and debt issuance costs ( 1,364 ) Total long-term debt, net $ 52,636 On April 29, 2022, the Company entered into a new five-year $ 150.0 million credit facility with entities affiliated with MidCap Financial Trust (“MidCap”), providing up to $ 120.0 million in term loans and a $ 30.0 million revolving credit facility. The term loan provides for a 60-month term loan facility up to $ 120.0 million in borrowing capacity to the Company, over four tranches. At loan closing, the Company drew $ 50.0 million under tranche one. The remaining tranches provide up to an additional $ 70.0 million in borrowing capacity in the aggregate, subject to the achievement of certain revenue targets. The revolving credit facility provides up to $ 30.0 million in borrowing capacity to the Company based on the borrowing base. The borrowing base is calculated based on certain accounts receivable and inventory assets. At loan closing, the Company drew $ 4.0 million under the revolving credit facility. The Company may request a $ 20.0 million increase in the revolving loan facility for a total commitment of up to $ 50.0 million. The Company is required to either (1) maintain a minimum drawn balance under the revolving facility agreement or (2) pay a minimum balance fee that is equal to the amount of the minimum balance deficit multiplied by the applicable interest rate during the period. If the outstanding balance under the revolving loan facility exceeds the lesser of (1) 50 % of the revolving borrowing capacity or (2) 50 % of the borrowing base, or the Company is in default, MidCap will apply funds collected from the Company's lockbox account to reduce the outstanding balance of the revolving loan facility (“Lockbox Deductions”). As of September 30, 2022, the Company's borrowing level has not activated the Lockbox Deductions, nor is it expected to for the next 12 months; therefore, the Company has determined that the revolving loan balance is long-term debt. The loans bear interest at an annual rate based on a 30-day forward looking secured overnight financing rate plus 0.10 % (subject to a floor of 1.0 % and a cap of 3.0 % for both loan agreements) plus (1) 6.0 % under the term loan agreement and (2) 4.0 % under the revolving credit facility. Interest is payable monthly in arrears on the first day of each month and on the maturity of the loan agreements. The Company is obligated to pay interest only for the first 48 months and straight-line amortization for the remaining 12 months, subject to the Company’s election to extend the initial interest-only period by 12 months to 60 months total if the Company’s trailing twelve-month revenue is at or above certain levels. If the term loan is repaid before the maturity date or the revolving credit facility is terminated before the end of its term, the prepayment fees are 3.0 % of the amount repaid in the first year, 2.0 % in the second year and 1.0 % in the third year and thereafter, and a final payment fee of 3.0 % of the amount borrowed is due under the term loan. The revolving credit facility prepayment fees are based on the revolving loan commitment amount. The loans are secured by substantially all of the Company’s assets, including intellectual property. The loan agreements and other ancillary documents contain customary representations and warranties and affirmative and negative covenants. Under the loan agreements, the Company is not required to meet any minimum level of revenue if liquidity (defined as unrestricted cash plus undrawn availability under the revolving loan agreement) is greater than the outstanding balance under the term loan. If liquidity falls below such outstanding balance, then the Company is subject to a minimum trailing twelve-month revenue covenant. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies License and Royalty Commitments As of September 30, 2022 and December 31, 2021, the Company has royalty agreements with certain members of its surgeon advisory board. The Company recognized royalty expense under these agreements of $ 1.6 million and $ 1.1 million for the three months ended September 30, 2022 and 2021, respectively, an d $ 4.3 milli on and $ 2.8 million for the nine months ended September 30, 2022 and 2021, respectively. For the three months ended September 30, 2022 and 2021 , the aggregate royalty rates were 4.8 % and 5.3 % respectively. For the nine months ended September 30, 2022 and 2021 , the aggregate royalty rates were 4.7 % and 4.5 %, respectively. Contingencies From time to time, the Company may be a party to various litigation claims in the normal course of business. Legal fees and other costs associated with such actions are expensed as incurred. The Company assesses, in conjunction with legal counsel, the need to record a liability for litigation and contingencies. Accrual estimates are recorded when and if it is determinable that such a liability for litigation and contingencies are both probable and reasonably estimable. There were no accrued contingent liabilities as of September 30, 2022 and December 31, 2021 . |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2022 | |
Operating Lease, Liability [Abstract] | |
Operating Leases | 8. Operating Leases The Company’s leases consist of real estate leases in Ponte Vedra, Florida. On February 9, 2022, the Company entered into a 10-year operating lease for a new corporate headquarters building in Ponte Vedra, Florida, with a lease commencement date of March 1, 2022. The Company's obligation to make cash payments for the new headquarters building started in the third quarter of 2022. The Company’s leases contain various options to renew, none of which the Company is reasonably certain to exercise. The lease agreements do not contain any residual value guarantees or restrictive covenants. For the new headquarters lease, the Company is provided a tenant improvement allowance for the construction of leasehold improvements. In exchange for construction management and supervision services related to these improvements, the Company pays the lessor a fee equal to one and a half percent ( 1.5 %) of total construction costs. In addition to base rent, the Company will pay variable costs related to its share of operating expenses under certain of its lease arrangements. These variable costs are recorded as lease expense as incurred and presented as operating expenses in the statements of operations and comprehensive loss. Variable lease costs were $ 0.1 million and $ 0.1 million for the three and nine months ended as of September 30, 2022. Rent expense was $ 0.3 and $ 0.5 for the three and nine months ended September 30, 2021, respectively. Operating lease cost was $ 0.8 million and $ 1.9 million for the three and nine months ended September 30, 2022, respectively. During the three and nine months ended September 30, 2022, cash paid for amounts included in operating lease liabilities of $ 0.5 million and $ 0.8 million, respectively, was included in cash flows from operating activities on the condensed statements of cash flows. Additional information related to operating leases is as follows: September 30, 2022 Weighted average remaining lease term (years) 9.4 Weighted average discount rate 9.2 % The following table summarizes future minimum lease payments on operating leases as of December 31, 2021 (in thousands): Fiscal Year 2022 $ 627 2023 444 2024 458 2025 472 2026 321 Total $ 2,322 The following table summarizes a maturity analysis of operating lease liabilities showing the aggregate lease payments as of September 30, 2022 (in thousands): Fiscal Year 2022 remaining * $ 308 2023 2,161 2024 2,932 2025 3,421 2026 3,339 Thereafter 18,094 Total undiscounted lease payments 30,255 Less: imputed interest ( 10,899 ) Total discounted lease payments 19,356 Less: Current portion of lease liability ( 330 ) Noncurrent portion of lease liability $ 19,026 * Includes the tenant improvement allowance |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Stock Option Plans During the nine months ended September 30, 2022 and 2021, the Company granted stock options to employees to purchase an aggregate o f 1,237,675 and 1,787,761 shares respectively, of the Company’s common stock. The weighted-average grant-date fair value of the employee stock options granted during the nine months ended September 30, 2022 and 2021 were $ 7.32 and $ 6.90 per share, respectively. Restricted Stock Units During the nine months ended September 30, 2022 , the Company granted 499,244 restricted st ock units (“RSUs”) The weighted average grant-date fair value of RSUs granted during the nine months ended September 30, 2022 w as $ 18.46 . The Company did not grant RSUs during the nine months ended September 30, 2021. Share-Based Compensation Expense Share-based compensation expense is reflected in operating expenses in the condensed statements of operations and comprehensive loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Sales and marketing $ 809 $ 278 $ 2,030 $ 795 Research and development 174 129 500 295 General and administrative 1,286 432 3,111 1,026 Total $ 2,269 $ 839 $ 5,641 $ 2,116 |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | 10. Net Loss Per Share Attributable to Common Stockholders The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders which is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. As the Company reported a net loss for the three and nine months ended September 30, 2022 and 2021, basic net loss per share attributable to common stockholders was the same as diluted net loss per share attributable to common stockholders as the inclusion of potentially dilutive shares would have been antidilutive if included in the calculation (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Numerator Net loss $ ( 12,133 ) $ ( 6,418 ) $ ( 38,403 ) $ ( 13,933 ) Adjust: Convertible preferred stock cumulative — — — ( 196 ) Net loss attributable to common stockholders ( 12,133 ) ( 6,418 ) ( 38,403 ) ( 14,129 ) Denominator Weighted-average common stock outstanding, 55,429,211 52,766,150 55,190,587 46,603,487 Net loss per share attributable to common $ ( 0.22 ) $ ( 0.12 ) $ ( 0.70 ) $ ( 0.30 ) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company’s net loss, in common stock equivalent shares: September 30, December 31, 2022 2021 Common stock options issued and outstanding 7,209,997 7,464,580 Unvested restricted stock units 499,284 29,024 Total 7,709,281 7,493,604 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The condensed financial statements have been prepared on the same basis as the Company’s annual financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 4, 2022. The unaudited condensed financial statements included herein reflect all adjustments, including normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. The results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for future quarters or for the fiscal year ending December 31, 2022. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC” ) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting periods. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Significant estimates and assumptions include reserves and write-downs related to accounts receivable, inventories, the recoverability of long-term assets, valuation of equity instruments, valuation of common stock, stock-based compensation, deferred tax assets and related valuation allowances and impact of contingencies. The Company had no accrued contingent liabilities as of September 30, 2022 and December 31, 2021 . |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of risk consist principally of cash, cash equivalents and accounts receivable. The Company maintains its cash and cash equivalents balances with established financial institutions and, at times, such balances with any one financial institution may be in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits. The Company earns revenue from the sale of its products to customers such as hospitals and ambulatory surgery centers. The Company’s accounts receivable is derived from revenue earned from customers. The Company performs ongoing credit evaluations of its customers’ financial condition. At September 30, 2022 and December 31, 2021 , no customer accounted for more than 10 % of accounts receivable. For the nine months ended September 30, 2022 and 2021 , there were no customers that represented 10 % or more of revenue. |
Leases | Leases The Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease is classified as a financing lease or operating lease at the commencement date of the lease. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The Company determines the commencement date of a lease to be the date on which a lessor makes an underlying asset available for use by the Company. Leases with a term greater than one year are recognized on the balance sheet as operating lease right-of-use assets, operating lease liabilities and operating lease liabilities, net of current portion. The Company elected not to recognize right-of-use assets and lease liabilities for leases with terms of 12 months or less (short-term leases). As the interest rates implicit in our lease contracts are not readily determinable, the Company utilizes its incremental borrowing rate based on the information available at the commencement date to determine the present value of lease payments. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid, incentives received, or impairment charges if the Company determines the right-of-use asset is impaired. The Company considers the lease term to be the noncancelable period that the Company has the right to use the underlying asset, together with any periods where it is reasonably certain the Company will exercise an option to extend (or not terminate) the lease. Rent expense for operating leases is recognized on a straight-line basis over the lease term and is presented in operating expenses on the statements of operations and comprehensive loss. The Company has elected to not separate lease and non-lease components for its real estate leases and instead accounts for each separate lease component and the non-lease components associated with that lease component as a single lease component. Variable lease payments are recognized as lease expense as incurred and are recorded in operating expenses on the statements of operations and comprehensive loss. The Company has no finance leases. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis | Assets and Liabilities Measured and Recorded at Fair Value on a Recurring Basis – The following assets and liabilities are measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021: September 30, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 85,839 $ — $ — $ 85,839 Total $ 85,839 $ — $ — $ 85,839 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 105,220 $ — $ — $ 105,220 Total $ 105,220 $ — $ — $ 105,220 Liabilities: Derivative liability $ — $ — $ 173 $ 173 Total $ — $ — $ 173 $ 173 (1) Money market funds are included in cash and cash equivalents in the condensed balance sheets as of September 30, 2022 and December 31, 2021 . |
summary of the changes in the fair value of the Companies Level 3 financial instruments | The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands): Derivative liability Fair value as of January 1, 2022 $ 173 Change in fair value included in other expense, net ( 173 ) Fair value as of September 30, 2022 $ — |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Cash and Cash Equivalents | The Company’s cash and cash equivalents consisted of the following (in thousands): September 30, December 31, 2022 2021 Cash $ 2,707 $ 613 Cash equivalents: Money market funds 85,839 105,220 Total cash and cash equivalents $ 88,546 $ 105,833 |
Summary of Property and Equipment, Net | The Company’s property and equipment, net consisted of the following (in thousands): September 30, December 31, 2022 2021 Furniture and fixtures, and equipment $ 1,443 $ 180 Construction in progress 723 126 Machinery and equipment 768 274 Capitalized surgical equipment 7,950 4,442 Computer equipment 426 160 Leasehold improvements 6,231 268 Software 138 138 Total property and equipment 17,679 5,588 Less: accumulated depreciation and amortization ( 3,531 ) ( 2,739 ) Property and equipment, net $ 14,148 $ 2,849 |
Summary of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, December 31, 2022 2021 Accrued royalty expense $ 1,659 $ 1,522 Accrued interest 381 975 Accrued professional services 1,027 941 Other accrued expense 2,122 1,080 Total accrued liabilities $ 5,189 $ 4,518 |
Long Term Debt (Tables)
Long Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Long-term Debt Instruments | The Company’s long-term debt consisted of the following (in thousands): September 30, December 31, 2022 2021 Revolving line of credit MidCap revolving credit facility $ 4,000 $ — Term loans CRG term loan facility — 30,000 MidCap term loan facility 50,000 — Total term and revolving loans 54,000 30,000 Less: debt discount and issuance costs ( 1,364 ) ( 635 ) Total long-term debt, net $ 52,636 $ 29,365 |
Summary of Maturities of Long-term Debt | As of September 30, 2022, future payments of long-term debt were as follows (in thousands): Fiscal Year 2022 (remaining six months) $ — 2023 — 2024 — 2025 — 2026 33,333 2027 20,667 Total principal payments 54,000 Less: Unamortized debt discount and debt issuance costs ( 1,364 ) Total long-term debt, net $ 52,636 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Operating Lease, Liability [Abstract] | |
summary of operating leases | Additional information related to operating leases is as follows: September 30, 2022 Weighted average remaining lease term (years) 9.4 Weighted average discount rate 9.2 % |
Summary of future minimum lease payments and maturity analysis of operating lease liabilities | The following table summarizes future minimum lease payments on operating leases as of December 31, 2021 (in thousands): Fiscal Year 2022 $ 627 2023 444 2024 458 2025 472 2026 321 Total $ 2,322 The following table summarizes a maturity analysis of operating lease liabilities showing the aggregate lease payments as of September 30, 2022 (in thousands): Fiscal Year 2022 remaining * $ 308 2023 2,161 2024 2,932 2025 3,421 2026 3,339 Thereafter 18,094 Total undiscounted lease payments 30,255 Less: imputed interest ( 10,899 ) Total discounted lease payments 19,356 Less: Current portion of lease liability ( 330 ) Noncurrent portion of lease liability $ 19,026 * Includes the tenant improvement allowance |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Summary of Share-Based Compensation Expense is Reflected in operating expense in the Condensed Statements of Operations and Comprehensive Loss | Share-based compensation expense is reflected in operating expenses in the condensed statements of operations and comprehensive loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Sales and marketing $ 809 $ 278 $ 2,030 $ 795 Research and development 174 129 500 295 General and administrative 1,286 432 3,111 1,026 Total $ 2,269 $ 839 $ 5,641 $ 2,116 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share Attributable to Common Stockholders, Basic and Diluted | As the Company reported a net loss for the three and nine months ended September 30, 2022 and 2021, basic net loss per share attributable to common stockholders was the same as diluted net loss per share attributable to common stockholders as the inclusion of potentially dilutive shares would have been antidilutive if included in the calculation (in thousands, except share and per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Numerator Net loss $ ( 12,133 ) $ ( 6,418 ) $ ( 38,403 ) $ ( 13,933 ) Adjust: Convertible preferred stock cumulative — — — ( 196 ) Net loss attributable to common stockholders ( 12,133 ) ( 6,418 ) ( 38,403 ) ( 14,129 ) Denominator Weighted-average common stock outstanding, 55,429,211 52,766,150 55,190,587 46,603,487 Net loss per share attributable to common $ ( 0.22 ) $ ( 0.12 ) $ ( 0.70 ) $ ( 0.30 ) |
Summary of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an antidilutive impact due to the Company’s net loss, in common stock equivalent shares: September 30, December 31, 2022 2021 Common stock options issued and outstanding 7,209,997 7,464,580 Unvested restricted stock units 499,284 29,024 Total 7,709,281 7,493,604 |
Formation and Business of the_2
Formation and Business of the Company - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 9 Months Ended | |||
Apr. 27, 2021 | Jun. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Formation And Business Of The Company [Line Items] | |||||
Company incorporation date of incorporation | Jul. 29, 2013 | ||||
Stock issued during the period shares including sale by the existing shareholders | 12,937,500 | ||||
Sale of stock issue price per share | $ 17 | ||||
Underwriting discounts and commissions | $ 8,300 | ||||
Adjustment to additional paid in capital stock issuance costs | $ 2,300 | ||||
Preferred stock shares outstanding converted into equity shares | 6,687,475 | ||||
Common stock shares authorized | 300,000,000 | 300,000,000 | |||
Preferred stock shares authorized | 5,000,000 | 5,000,000 | |||
Accumulated deficit | $ (80,308) | $ (41,905) | |||
Net cash used in operating activities | (25,290) | $ (13,441) | |||
Cash and cash equivalents | $ 88,546 | $ 105,833 | |||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | |||
Preferred stock par or stated value per share | $ 0.001 | $ 0.001 | |||
IPO [Member] | |||||
Formation And Business Of The Company [Line Items] | |||||
Stock issued during the period shares new issues | 6,953,125 | ||||
Sale of stock by the existing shareholders | 5,984,375 | ||||
Sale of stock net consideration received on the transaction | $ 107,600 | ||||
Selling Stockholders [Member] | |||||
Formation And Business Of The Company [Line Items] | |||||
Proceeds from sale of shares | $ 0 | ||||
Over-Allotment Option [Member] | |||||
Formation And Business Of The Company [Line Items] | |||||
Stock issued during the period shares new issues | 703,125 | ||||
Sale of stock by the existing shareholders | 984,375 | ||||
Series A Convertible Preferred Stock [Member] | |||||
Formation And Business Of The Company [Line Items] | |||||
Stock shares issued during the period shares dividends | 158,447 | ||||
Stock shares issued during the period value dividends | $ 2,500 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Accrued contingent liabilities | $ 0 | $ 0 | |
Minimum [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 10% | 10% | |
Maximum [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 10% | 10% |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Operating lease right-of-use assets | $ 14,247 | $ 1,900 | $ 0 |
Operating lease liabilities | $ 330 | $ 1,900 | $ 0 |
Asc 842Topic [Member] | Minimum [Member] | |||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Lessee, operating lease, term of contract | 12 months |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | |
Assets: | |||
Money market funds | $ 85,839 | [1] | $ 105,220 |
Total | 85,839 | 105,220 | |
Liabilities: | |||
Derivative liability | 173 | ||
Total | 173 | ||
Level 1 [Member] | |||
Assets: | |||
Money market funds | 85,839 | [1] | 105,220 |
Total | $ 85,839 | 105,220 | |
Level 3 [Member] | |||
Liabilities: | |||
Derivative liability | 173 | ||
Total | $ 173 | ||
[1] Money market funds are included in cash and cash equivalents in the condensed balance sheets as of September 30, 2022 and December 31, 2021 . |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of the changes in the fair value of the Companies Level 3 financial instruments (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value as of September 30, 2022 | $ 0 |
Fair Value, Inputs, Level 3 [Member] | DerivativeMember | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value as of January 1, 2022 | 173 |
Change in fair value included in other expense, net | $ (173) |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Cash and Cash Equivalents (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Cash | $ 2,707 | $ 613 |
Money market funds | 85,839 | 105,220 |
Total cash and cash equivalents | $ 88,546 | $ 105,833 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 17,679 | $ 5,588 |
Less: accumulated depreciation and amortization | (3,531) | (2,739) |
Property and equipment, net | 14,148 | 2,849 |
Furniture and Fixtures and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,443 | 180 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 723 | 126 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 768 | 274 |
Capitalized Surgical Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 7,950 | 4,442 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 426 | 160 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 6,231 | 268 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 138 | $ 138 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Dec. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Line Items] | ||||||
Depreciation and amortization expense | $ 400 | $ 200 | $ 1,216 | $ 409 | ||
Cash | 2,707 | 2,707 | $ 613 | |||
Scenario forecast | ||||||
Cash and Cash Equivalents [Line Items] | ||||||
Money market funds and various investments | $ 65,000 | |||||
Silicon Valley Bank | ||||||
Cash and Cash Equivalents [Line Items] | ||||||
Cash | $ 900 | $ 900 | $ 0 |
Balance Sheet Components - Su_3
Balance Sheet Components - Summary of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued royalty expense | $ 1,659 | $ 1,522 |
Accrued interest | 381 | 975 |
Accrued professional services | 1,027 | 941 |
Other accrued expense | 2,122 | 1,080 |
Total accrued liabilities | $ 5,189 | $ 4,518 |
Long Term Debt - Additional Inf
Long Term Debt - Additional Information (Detail) | Apr. 29, 2022 USD ($) |
Debt Instrument [Line Items] | |
Line Of Credit Facility, Borrowing Capacity Description | The Company is required to either (1) maintain a minimum drawn balance under the revolving facility agreement or (2) pay a minimum balance fee that is equal to the amount of the minimum balance deficit multiplied by the applicable interest rate during the period. If the outstanding balance under the revolving loan facility exceeds the lesser of (1) 50% of the revolving borrowing capacity or (2) 50% of the borrowing base, or the Company is in default, MidCap will apply funds collected from the Company's lockbox account to reduce the outstanding balance of the revolving loan facility (“Lockbox Deductions”). |
Revolving borrowing capacity percentage | 50% |
Line of credit, interest description | The loans bear interest at an annual rate based on a 30-day forward looking secured overnight financing rate plus 0.10% (subject to a floor of 1.0% and a cap of 3.0% for both loan agreements) plus (1) 6.0% under the term loan agreement and (2) 4.0% under the revolving credit facility. |
Term loan repayment term | Interest is payable monthly in arrears on the first day of each month and on the maturity of the loan agreements. The Company is obligated to pay interest only for the first 48 months and straight-line amortization for the remaining 12 months, subject to the Company’s election to extend the initial interest-only period by 12 months to 60 months total if the Company’s trailing twelve-month revenue is at or above certain levels. |
Debt instrument repayment fee percentage for first year | 3% |
Debt instrument repayment fee percentage for third year | 1% |
Debt instrument repayment fee percentage final | 3% |
SOFR | Floor | |
Debt Instrument [Line Items] | |
Debt Instrument Basis Spread On Variable Rate1 | 1% |
SOFR | Cap | |
Debt Instrument [Line Items] | |
Debt Instrument Basis Spread On Variable Rate1 | 3% |
Tranche One | |
Debt Instrument [Line Items] | |
Borrowings | $ 50,000,000 |
Tranche Four | |
Debt Instrument [Line Items] | |
Borrowings | $ 120,000 |
MidCap Financial Trust | |
Debt Instrument [Line Items] | |
Term loan tenure | 5 years |
Line of credit | $ 150,000,000 |
Debt Instrument, Face Amount | $ 120,000,000 |
Revolving borrowing capacity percentage | 50% |
Year Two | |
Debt Instrument [Line Items] | |
Debt instrument repayment fee percentage for second year | 2% |
Term Loans [Member] | |
Debt Instrument [Line Items] | |
Remaining borrowing capacity | $ 70,000,000 |
Debt Instrument Interest Rate | 6% |
Revolving Credit Facility [Member] | |
Debt Instrument [Line Items] | |
Line of credit current borrowing capacity | $ 4,000,000 |
Remaining borrowing capacity | 30,000,000 |
Borrowings | 50,000,000 |
Debt Instrument, Face Amount | 30,000,000 |
Increase in credit facility | $ 20,000 |
Debt Instrument Interest Rate, Percentage | 0.10% |
Debt Instrument Interest Rate | 4% |
Long Term Debt - Summary of Lon
Long Term Debt - Summary of Long-term Debt Instruments (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Total term loans | $ 54,000 | $ 30,000 |
Less: Unamortized debt discount and debt issuance costs | (1,364) | (635) |
Total long-term debt, net | 52,636 | 29,365 |
Mid Cap Revolving Credit Facility | ||
Debt Instrument [Line Items] | ||
Total term loans | 4,000 | 0 |
Term Loans [Member] | CRG Term Loan Facility [Member] | ||
Debt Instrument [Line Items] | ||
Total term loans | 0 | $ 30,000 |
Term Loans [Member] | MidCap Term loan facility | ||
Debt Instrument [Line Items] | ||
Total term loans | $ 50,000 |
Long Term Debt - Summary of Mat
Long Term Debt - Summary of Maturities of Long-term Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2022 | $ 0 | |
2023 | 0 | |
2024 | 0 | |
2025 | 0 | |
2026 | 33,333 | |
2027 | 20,667 | |
Total principal payments | 54,000 | $ 30,000 |
Less: Unamortized debt discount and debt issuance costs | (1,364) | $ (635) |
Total long-term debt, net | $ 52,636 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Other Commitments [Line Items] | |||||
Accrued contingent liabilities | $ 0 | $ 0 | $ 0 | ||
Royalty Agreement With Certain Members Of The Surgeon Advisory Board [Member] | Ten Years From The First Sale Of The Commercial Product Member [Member] | |||||
Other Commitments [Line Items] | |||||
Royalty expenses | $ 1,600,000 | $ 1,100,000 | $ 4,300,000 | $ 2,800,000 | |
Royalty as a percentage of net sales for the period | 4.80% | 5.30% | 4.70% | 4.50% |
Operating Leases - Additional I
Operating Leases - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Lease, Liability [Abstract] | ||||
Operating lease term | 10 years | 10 years | ||
Percentage of construction cost paid as fee to lessor | (1.50%) | |||
Variable lease costs | $ 0.1 | $ 0.1 | ||
Rent expense | $ 0.3 | $ 0.5 | ||
Operating lease cost | 0.8 | 1.9 | ||
Cash paid for operating lease liabilities | $ 0.5 | $ 0.8 |
Operating Leases - Summary of O
Operating Leases - Summary of Operating Leases (Detail) | Sep. 30, 2022 |
Operating Lease, Liability [Abstract] | |
Weighted-average remaining lease term (years) | 9 years 4 months 24 days |
Weighted average discount rate | 9.20% |
Operating Leases - Summary of F
Operating Leases - Summary of Future Minimum Lease Payments and Maturity Analysis of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 | |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||||
2022 | $ 308 | [1] | $ 627 | |
2022 remaining | 308 | [1] | 627 | |
2023 | 2,161 | 444 | ||
2024 | 2,932 | 458 | ||
2025 | 3,421 | 472 | ||
2026 | 3,339 | 321 | ||
Thereafter | 18,094 | |||
Total undiscounted lease payments | 30,255 | 2,322 | ||
Less: imputed interest | 10,899 | |||
Total discounted lease payments | 19,356 | |||
Less: Current portion of lease liability | 330 | $ 1,900 | 0 | |
Noncurrent portion of lease liability | $ 19,026 | $ 0 | ||
[1] Includes the tenant improvement allowance |
Stockholders' Equity (Additiona
Stockholders' Equity (Additional Information) (Detail) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Employees stock options, shares granted | 1,237,675 | 1,787,761 |
Restricted Stock [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Shares granted | 499,244 | |
Weighted average grant-date fair value | $ 18.46 | |
Employee Stock Option [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock options, weighted-average grant date fair value | $ 7.32 | $ 6.90 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Share-Based Compensation Expense is Reflected in Operating expenses in the Condensed Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 2,269 | $ 839 | $ 5,641 | $ 2,116 |
Sales and marketing [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 809 | 278 | 2,030 | 795 |
Research and development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 174 | 129 | 500 | 295 |
General and administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 1,286 | $ 432 | $ 3,111 | $ 1,026 |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Schedule of Net Loss Per Share Attributable to Common Stockholders, Basic and Diluted (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator | ||||||||
Net loss | $ (12,133) | $ (17,234) | $ (9,036) | $ (6,418) | $ (5,083) | $ (2,432) | $ (38,403) | $ (13,933) |
Convertible preferred stock cumulative and undeclared dividends | 0 | 0 | 0 | (196) | ||||
Net loss attributable to common stockholders | $ (12,133) | $ (6,418) | $ (38,403) | $ (14,129) | ||||
Denominator | ||||||||
Weighted Average Number of Shares Outstanding, Basic | 55,429,211 | 52,766,150 | 55,190,587 | 46,603,487 | ||||
Weighted Average Number of Shares Outstanding, Diluted | 55,429,211 | 52,766,150 | 55,190,587 | 46,603,487 | ||||
Earnings Per Share, Basic | $ (0.22) | $ (0.12) | $ (0.70) | $ (0.30) | ||||
Earnings Per Share, Diluted | $ (0.22) | $ (0.12) | $ (0.70) | $ (0.30) |
Net Loss Per Share Attributab_4
Net Loss Per Share Attributable to Common Stockholders - Summary of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding (Detail) - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Diluted weighted average shares outstanding | 7,709,281 | 7,493,604 |
Common Stock Options Issued and Outstanding [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Diluted weighted average shares outstanding | 7,209,997 | 7,464,580 |
Unvested Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Diluted weighted average shares outstanding | 499,284 | 29,024 |