Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Sonendo, Inc. | |
Entity Central Index Key | 0001407973 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 54,278,123 | |
Entity File Number | 001-40988 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-5041718 | |
Entity Address, Address Line One | 26061 Merit Circle | |
Entity Address, Address Line Two | Suite 102 | |
Entity Address, City or Town | Laguna Hills | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92653 | |
City Area Code | 949 | |
Local Phone Number | 766-3636 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | SONX | |
Security Exchange Name | NYSE |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 12,090 | $ 17,665 |
Short-term investments | 43,849 | 73,784 |
Accounts receivable, net | 5,600 | 5,798 |
Inventory | 11,442 | 15,462 |
Prepaid expenses and other current assets | 2,510 | 8,397 |
Total current assets | 75,491 | 121,106 |
Property and equipment, net | 216 | 2,860 |
Operating lease right-of-use assets | 3,300 | 2,455 |
Intangible assets, net | 748 | 2,292 |
Goodwill | 8,454 | 8,454 |
Other assets | 118 | 118 |
Total assets | 88,327 | 137,285 |
Current liabilities: | ||
Accounts payable | 950 | 4,438 |
Accrued expenses | 3,817 | 5,357 |
Accrued compensation | 3,110 | 3,616 |
Operating lease liabilities | 1,334 | 1,114 |
Other current liabilities | 1,840 | 2,191 |
Total current liabilities | 11,051 | 16,716 |
Operating lease liabilities, net of current | 1,782 | 1,095 |
Term loan, net | 37,202 | 36,746 |
Other liabilities | 512 | 773 |
Total liabilities | 50,547 | 55,330 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; authorized -10,000,000 shares; issued and outstanding - none | ||
Common stock, $0.001 par value; authorized - 500,000,000 shares; issued and outstanding - 52,971,301 shares as of September 30, 2023 and 49,974,281 shares as of December 31, 2022 | 53 | 50 |
Additional paid-in-capital | 456,868 | 451,060 |
Accumulated other comprehensive loss | (6) | (61) |
Accumulated deficit | (419,135) | (369,094) |
Total stockholders' equity | 37,780 | 81,955 |
Total liabilities and stockholders' equity | $ 88,327 | $ 137,285 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 52,971,301 | 49,974,281 |
Common stock, shares outstanding | 52,971,301 | 49,974,281 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Total revenue | $ 10,406 | $ 9,846 | $ 32,173 | $ 29,426 |
Cost of sales, product and software | 6,619 | 7,528 | 23,942 | 22,276 |
Impairment of long-lived assets | 1,341 | 1,341 | ||
Total cost of sales | 7,960 | 7,528 | 25,283 | 22,276 |
Gross profit | 2,446 | 2,318 | 6,890 | 7,150 |
Operating expenses: | ||||
Selling, general and administrative | 13,442 | 12,586 | 42,859 | 37,393 |
Research and development | 3,049 | 4,328 | 9,841 | 13,196 |
Impairment of long-lived assets | 2,051 | 2,051 | ||
Total operating expenses | 18,542 | 16,914 | 54,751 | 50,589 |
Loss from operations | (16,096) | (14,596) | (47,861) | (43,439) |
Interest and financing costs, net | (884) | (943) | (2,180) | (2,759) |
Loss before income tax expense | (16,980) | (15,539) | (50,041) | (46,198) |
Net loss | (16,980) | (15,539) | (50,041) | (46,198) |
Other comprehensive income (loss) (net of tax): | ||||
Unrealized (loss) gain on short-term investments | 24 | (7) | 55 | (49) |
Comprehensive loss | $ (16,956) | $ (15,546) | $ (49,986) | $ (46,247) |
Net loss per share - basic | $ (0.18) | $ (0.47) | $ (0.53) | $ (1.61) |
Net loss per share - diluted | $ (0.18) | $ (0.47) | $ (0.53) | $ (1.61) |
Weighted-average shares outstanding - basic | 94,286,107 | 33,116,536 | 93,790,557 | 28,688,018 |
Weighted-average shares outstanding - diluted | 94,286,107 | 33,116,536 | 93,790,557 | 28,688,018 |
Product | ||||
Total revenue | $ 8,163 | $ 7,795 | $ 25,604 | $ 23,440 |
Cost of sales, product and software | 5,938 | 6,875 | 21,886 | 20,338 |
Impairment of long-lived assets | 1,341 | 1,341 | ||
Total cost of sales | 7,279 | 6,875 | 23,227 | 20,338 |
Gross profit | 884 | 920 | 2,377 | 3,102 |
Operating expenses: | ||||
Selling, general and administrative | 12,847 | 12,141 | 41,070 | 35,911 |
Research and development | 2,551 | 3,891 | 8,242 | 11,874 |
Impairment of long-lived assets | 2,051 | 2,051 | ||
Total operating expenses | 17,449 | 16,032 | 51,363 | 47,785 |
Loss from operations | (16,565) | (15,112) | (48,986) | (44,683) |
Software | ||||
Total revenue | 2,243 | 2,051 | 6,569 | 5,986 |
Cost of sales, product and software | 681 | 653 | 2,056 | 1,938 |
Total cost of sales | 681 | 653 | 2,056 | 1,938 |
Gross profit | 1,562 | 1,398 | 4,513 | 4,048 |
Operating expenses: | ||||
Selling, general and administrative | 595 | 445 | 1,789 | 1,482 |
Research and development | 498 | 437 | 1,599 | 1,322 |
Total operating expenses | 1,093 | 882 | 3,388 | 2,804 |
Loss from operations | $ 469 | $ 516 | $ 1,125 | $ 1,244 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance at Dec. 31, 2021 | $ 72,063 | $ 26 | $ (51) | $ 384,132 | $ (312,044) | |
Beginning balance, Shares at Dec. 31, 2021 | 26,336,536 | |||||
Employee stock plans | 242 | 242 | ||||
Employee stock plans, Shares | 82,572 | |||||
Stock-based compensation | 1,394 | 1,394 | ||||
Net loss | (15,522) | (15,522) | ||||
Ending balance at Mar. 31, 2022 | 58,177 | $ 26 | (51) | 385,768 | (327,566) | |
Ending balance, Shares at Mar. 31, 2022 | 26,419,108 | |||||
Beginning balance at Dec. 31, 2021 | 72,063 | $ 26 | (51) | 384,132 | (312,044) | |
Beginning balance, Shares at Dec. 31, 2021 | 26,336,536 | |||||
Unrealized (loss) gain on short-term investments | (49) | |||||
Net loss | (46,198) | |||||
Ending balance at Sep. 30, 2022 | 90,356 | $ 50 | (51) | 448,648 | $ (49) | (358,242) |
Ending balance, Shares at Sep. 30, 2022 | 49,756,666 | |||||
Beginning balance at Mar. 31, 2022 | 58,177 | $ 26 | (51) | 385,768 | (327,566) | |
Beginning balance, Shares at Mar. 31, 2022 | 26,419,108 | |||||
Employee stock plans | 9 | $ 1 | 8 | |||
Employee stock plans, Shares | 150,112 | |||||
Stock-based compensation | 1,954 | 1,954 | ||||
Revaluation of warrants | 73 | 73 | ||||
Unrealized (loss) gain on short-term investments | (42) | (42) | ||||
Net loss | (15,137) | (15,137) | ||||
Ending balance at Jun. 30, 2022 | 45,034 | $ 27 | (51) | 387,803 | (42) | (342,703) |
Ending balance, Shares at Jun. 30, 2022 | 26,569,220 | |||||
Employee stock plans | 2 | 2 | ||||
Employee stock plans, Shares | 141,910 | |||||
Issuance of common stock, net of issuance costs | 20,568 | $ 23 | 20,545 | |||
Issuance of common stock, net of issuance costs, shares | 23,045,536 | |||||
Issuance of pre-funded warrants, net of issuance costs | 38,575 | 38,575 | ||||
Stock-based compensation | 1,723 | 1,723 | ||||
Unrealized (loss) gain on short-term investments | (7) | (7) | ||||
Net loss | (15,539) | (15,539) | ||||
Ending balance at Sep. 30, 2022 | 90,356 | $ 50 | $ (51) | 448,648 | (49) | (358,242) |
Ending balance, Shares at Sep. 30, 2022 | 49,756,666 | |||||
Beginning balance at Dec. 31, 2022 | 81,955 | $ 50 | 451,060 | (61) | (369,094) | |
Beginning balance, Shares at Dec. 31, 2022 | 49,974,281 | |||||
Employee stock plans, Shares | 216,105 | |||||
Stock-based compensation | 1,942 | 1,942 | ||||
Exercised of pre-funded warrants | 1 | $ 1 | ||||
Exercised of pre-funded warrants, Shares | 1,062,080 | |||||
Unrealized (loss) gain on short-term investments | 56 | 56 | ||||
Net loss | (15,371) | (15,371) | ||||
Ending balance at Mar. 31, 2023 | 68,583 | $ 51 | 453,002 | (5) | (384,465) | |
Ending balance, Shares at Mar. 31, 2023 | 51,252,466 | |||||
Beginning balance at Dec. 31, 2022 | 81,955 | $ 50 | 451,060 | (61) | (369,094) | |
Beginning balance, Shares at Dec. 31, 2022 | 49,974,281 | |||||
Unrealized (loss) gain on short-term investments | 55 | |||||
Net loss | (50,041) | |||||
Ending balance at Sep. 30, 2023 | 37,780 | $ 53 | 456,868 | (6) | (419,135) | |
Ending balance, Shares at Sep. 30, 2023 | 52,971,301 | |||||
Beginning balance at Mar. 31, 2023 | 68,583 | $ 51 | 453,002 | (5) | (384,465) | |
Beginning balance, Shares at Mar. 31, 2023 | 51,252,466 | |||||
Employee stock plans | 117 | $ 1 | 116 | |||
Employee stock plans, Shares | 698,016 | |||||
Stock-based compensation | 2,059 | 2,059 | ||||
Exercised of pre-funded warrants | $ 1 | (1) | ||||
Exercised of pre-funded warrants, Shares | 709,202 | |||||
Unrealized (loss) gain on short-term investments | (25) | (25) | ||||
Net loss | (17,690) | (17,690) | ||||
Ending balance at Jun. 30, 2023 | 53,044 | $ 53 | 455,176 | (30) | (402,155) | |
Ending balance, Shares at Jun. 30, 2023 | 52,659,684 | |||||
Employee stock plans | (92) | (92) | ||||
Employee stock plans, Shares | 264,809 | |||||
Stock-based compensation | 1,784 | 1,784 | ||||
Exercised of pre-funded warrants, Shares | 46,808 | |||||
Unrealized (loss) gain on short-term investments | 24 | 24 | ||||
Net loss | (16,980) | (16,980) | ||||
Ending balance at Sep. 30, 2023 | $ 37,780 | $ 53 | $ 456,868 | $ (6) | $ (419,135) | |
Ending balance, Shares at Sep. 30, 2023 | 52,971,301 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (50,041) | $ (46,198) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,094 | 744 |
Amortization intangible assets | 498 | 498 |
Amortization of right-of-use lease assets | 947 | 829 |
Impairment of long-lived assets | 3,392 | |
Stock-based compensation | 5,785 | 5,071 |
Amortization of debt issuance costs | 456 | 327 |
Other non-cash operating activities, net | (1,831) | (158) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 198 | (833) |
Inventory | 4,073 | (7,086) |
Prepaid expenses and other assets | 5,887 | 641 |
Accounts payable | (3,494) | (1,039) |
Accrued expenses and other liabilities | (2,996) | (409) |
Deferred revenue | (19) | 204 |
Accrued compensation | (506) | 583 |
Net cash used in operating activities | (36,557) | (46,826) |
Cash flows from investing activities: | ||
Purchases of available-for-sale securities | (49,978) | (45,664) |
Proceeds from maturities of available-for-sale securities | 81,800 | 8,700 |
Purchases of property and equipment | (843) | (1,031) |
Net cash provided by (used in) investing activities | 30,979 | (37,995) |
Financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 20,623 | |
Proceeds from debt, net of issuance costs | 9,850 | |
Payment of common stock IPO issuance costs | (598) | |
Issuance of stock under employee stock plans | 117 | 252 |
Taxes paid on vested stock awards under employee stock plans | (92) | |
Proceeds from exercise of pre-funded warrants | 1 | 38,722 |
Payment of contingent earnout | (117) | |
Principal repayments on finance lease | (23) | (40) |
Net cash provided by (used in) financing activities | 3 | 68,692 |
Net decrease in cash and cash equivalents | (5,575) | (16,129) |
Cash and cash equivalents at beginning of period | 17,665 | 84,641 |
Cash and cash equivalents at end of period | 12,090 | 68,512 |
Cash paid for: | ||
Interest | 4,319 | 2,804 |
Supplemental schedule of non-cash investing and financing activities: | ||
Operating lease right-of-use assets obtained in exchange for lease liabilities | $ 1,792 | $ 223 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Unless this Form 10-Q indicates otherwise or the context otherwise requires, the terms “we,” “our,” “us,” “Sonendo,” or the “Company” as used in this Form 10-Q refer to Sonendo, Inc . Description of Business Sonendo, Inc. was incorporated in June 2006 pursuant to the laws of the State of Delaware under the name Dentatek Corporation. In March 2011, the Company changed its name to Sonendo, Inc. The Company is a medical technology company that has developed and is commercializing the GentleWave System to treat tooth decay. The Company’s principal market is the United States. The Company’s products include the GentleWave System, which is cleared by the United States (“U.S.”) Food and Drug Administration (the “FDA”) for sale in the U.S. and approved by Health Canada in Canada, along with the system’s sterilized, single-use procedure instruments (“PIs”). In addition, the Company offers practice management software to enable an integrated digital office for dental practitioners. Basis of Presentation The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”) on a consistent basis with the Company’s annual financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, considered necessary for a fair statement of the Company’s financial information. 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 condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. The results of operations included in these condensed consolidated financial statements are not necessarily indicative of the results of operations to be expected for the year, any other interim period, or for any other future annual or interim period. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed, consolidated, or omitted. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on March 8, 2023. Liquidity On September 27, 2022, the Company completed a private placement (the “Private Placement”), issuing an aggregate of approximately 23.0 million shares of its common stock at a purchase price of $ 0.95 per share and pre-funded warrants to purchase an aggregate of 43.3 million shares of common stock at a purchase price of $ 0.949 per pre-funded warrant. The pre-funded warrants have an exercise price of $ 0.001 per share of common stock, are immediately exercisable and will remain exercisable until exercised in full. The aggregate net proceeds from the Private Placement, after deducting placement agent fees and other offering expenses, were $ 59.0 million. See Note 5, Stockholders' Equity, for additional information. As of September 30, 2023, the Company had cash and cash equivalents and short-term investments of $ 55.9 million . 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 net losses and negative cash flows from operations since its inception and as of September 30, 2023 had an accumulated deficit of $ 419.1 million . During the nine months ended September 30, 2023, the Company incurred net losses of $ 50.0 million and used $ 36.6 million of cash and cash equivalents in operations. In the nine months ended September 30, 2023, we received all of the $ 4.4 million payment of Employee Retention Credit ( “ERC”) recognized in other income in 2022. The Company will continue to incur significant costs and expenses related to its ongoing operations until it gains market acceptance of its products and achieves a level of revenues adequate to support its operations. The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. Based on its current operating plan, the Company expects that its existing cash and cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the date of issuance of the accompanying unaudited condensed consolidated financial statements. The Company plans to fund its operations, capital funding and other liquidity needs using existing cash, cash equivalents and short-term investments and, to the extent available, cash generated from commercial operations. If the Company's actual revenue is significantly less than its operating plan, the Company may fail to satisfy certain financial covenants which would constitute an event of default under the Perceptive Loan Agreement, as amended, which may further cause the lender to terminate its commitments and declare all amounts outstanding under the Perceptive Loan Agreement, as amended, immediately due and payable, together with accrued interest and all fees and other obligations (see Note 9, “ Term Loan ” for additional information). If the Company's actual operating expenses significantly exceed its operating plan, the Company may have to significantly delay or scale back its operations to reduce working capital requirements. Under these circumstances, substantial uncertainty would exist with respect to our ability to continue as a going concern. In addition, the Company would prioritize necessary and appropriate steps to enable the continued operations of the business and preservation of the value of its assets beyond the next 12 months, including but not limited to, actions such as reducing personnel-related costs and delaying or curtailing the Company’s commercial efforts, development activities and other discretionary expenditures that are within the Company’s control. These reductions in expenditures, if required, may have an adverse impact on the Company’s ability to achieve certain of its planned objectives. On March 10, 2023, the California Department of Financial Protection and Innovation shut down Silicon Valley Bank (“SVB”) due to liquidity concerns and appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. On March, 27, 2023, SVB began operating as a division of First Citizens Bank. As of September 30, 2023, the Company held approximately $ 1.1 million in operating accounts at SVB. The Company’s remaining cash and cash equivalents and short-term investments, consisting of money market funds, high-grade corporate securities, and U.S. government backed securities, reside in custodial accounts held by U.S. Bank. There has been no disruption to the Company's operations. Effects of the Macroeconomic Environment The Company’s unaudited condensed consolidated financial statements as of and for the nine months ended September 30, 2023 reflect the Company’s estimates of the impact of the macroeconomic environment, including the impact of inflation and higher interest rates. The duration and the scope of these conditions cannot be predicted; therefore, the extent to which these conditions will directly or indirectly impact the Company’s business, results of operations and financial condition, is uncertain. See Note 2, “ Long-Lived Assets ” , for a description of the impairment charges recorded in the three months ended September 30, 2023. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the date of this filing. Operating Segments The Company has business activity and operates two operating and reportable segments: Product and Software. Operating segments are defined as components of an enterprise for which discrete financial information is available and evaluated regularly by the chief operating decision maker, who is the Company’s chief executive officer (“CEO”), for the purpose of allocating resources and evaluating performance. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (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 elected to avail itself of this exemption and, therefore, for new or revised accounting standards applicable to public companies, the Company will be subject to an extended transition period until those standards would otherwise apply to private companies. |
Summary Accounting Policies and
Summary Accounting Policies and Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary Accounting Policies and Recent Accounting Pronouncements | 2. Summary Accounting Policies and Recent Accounting Pronouncements The accounting policies followed by the Company are set forth in Part II, Item 8, Note 2, Summary of Accounting Policies , of the Notes to Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates, judgements and assumptions that affect the reported amounts in the unaudited condensed consolidated financial statements and disclosures in the accompanying notes, including estimates of probable losses and expenses, as of the date of the accompanying unaudited condensed consolidated financial statements. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of these unaudited condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying unaudited condensed consolidated financial statements under different assumptions or conditions. Inventory Inventory consists of finished products, work-in-process and raw materials and is valued at the lower of cost or net realizable value. Cost may include materials, labor and manufacturing overhead. Cost is determined by the first in, first out inventory method. The carrying value of inventory is reviewed for potential impairment whenever indicators suggest that the cost of inventory exceeds the carrying value and management adjusts the inventory to its net realizable value. The Company also periodically evaluates inventory for estimated losses from excess quantities and obsolescence and writes down the cost of inventory 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 of completion and disposal. Long-Lived Assets The Company reviews its long-lived assets, which includes definite-lived intangibles, long-lived fixed assets and lease right-of-use assets, for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Factors that could trigger an impairment review include significant under-performance relative to expected historical or projected future operating results, significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business or significant negative industry or economic trends. If this evaluation indicates that the value of the long-lived asset may be impaired, the Company makes an assessment of the recoverability of the net carrying value of the asset over its remaining useful life. If this assessment indicates that the long-lived asset is not recoverable, based on the estimated undiscounted future cash flows of the technology over the remaining useful life, the Company reduces the net carrying value of the related asset to fair value and may adjust the remaining useful life. An impairment analysis is subjective and assumptions regarding future growth rates and operating expense levels can have a significant impact on the expected future cash flows and impairment analysis. In the third quarter of 2023, the significant decline in the Company's market capitalization was a triggering event, which resulted in the performance of an interim long-lived assets impairment assessment. The interim assessment indicated that the carrying amount of the Company's definite-lived intangible and long-lived fixed assets in its Product segment would not be recoverable. As a result , the Company recognized an impairment charge of $ 1.0 million to a definite-lived intangible, developed technology, which was recorded in operating expenses on the Condensed Consolidated Statements of Operations , and an impairment charge of $ 2.3 million to property and equipment, of which, $ 1.3 million was recorded in cost of sales and the remainder was recorded in operating expenses on the Condensed Consolidated Statements of Operations . No impairment of lease right-of-use assets was recognized as the fair value of the lease right-of-use assets exceeds their carrying amount. Goodwill Goodwill represents the excess of cost over fair value of identified assets acquired and liabilities assumed by the Company in an acquisition of a business. The determination of the value of goodwill and intangible assets arising from a business combination requires extensive use of accounting estimates and judgments to allocate the purchase price to the fair value of the net tangible and intangible assets acquired. The Company recorded $ 8.5 million of goodwill in conjunction with the acquisition of TDO. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. The Company performs its annual impairment analysis by either comparing a reporting unit’s estimated fair value to its carrying amount or doing a qualitative assessment of a reporting unit’s fair value from the last quantitative assessment to determine if there is potential impairment. The Company may do a qualitative assessment when the results of the previous quantitative test indicated the reporting unit’s estimated fair value was significantly in excess of the carrying value of its net assets and it does not believe there have been significant changes in the reporting unit’s operations that would significantly decrease its estimated fair value or significantly increase its net assets. If a quantitative assessment is performed, the evaluation includes management projections of future cash flows and/or use of a market approach by considering market values of comparable companies. Key assumptions for these projections include revenue growth, future gross and operating margin growth, and the weighted cost of capital and terminal growth rates. Revenue and margin growth are based on increased sales of new and existing products as the Company maintains investments in research and development. Additional value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation. The Company’s annual evaluation for impairment of goodwill consists of the software reporting unit from which the goodwill originated. The Company's annual goodwill testing is determined to be performed as of October 31. However, given the significant decline in the Company's market capitalization in the third quarter of 2023, the Company completed an evaluation for impairment as of September 30, 2023, using a quantitative assessment and determined that no impairment existed. The assumptions used in the estimate of fair value are generally consistent with the past performance of the Company and are also consistent with the projections and assumptions that are used in current operating plans. The assumptions are subject to change as a result of changing economic and competitive conditions. Revenue Recognition Contracts with Customers The Company recognizes revenue when it transfers promised goods or services to customers in an amount 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 core principles 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. Product revenue is generated from sales of the GentleWave Console and related PIs and accessories. Software revenue is generated from sales of TDO's endodontist practice management software licenses. The Company’s products are sold primarily in the United States and Canada directly to customers through its field sales force. Performance Obligations The Company’s performance obligations primarily arise from the manufacture and delivery of the GentleWave System, related PIs and accessories, and the delivery or license of TDO software and related ancillary services. Payment terms are typically on open credit terms consistent with industry practice and do not have significant financing components. Consideration may be variable based on volume. The Company considers the individual deliverables in its product offering as separate performance obligations and assesses whether each promised good or service is distinct. The total contract transaction price is determined based on the consideration expected to be received, based on the stated value in contractual arrangements or the estimated cash to be collected in no-contracted arrangements, and is allocated to the identified performance obligations based upon the relative standalone selling prices of the performance obligations. The stand-alone selling price is based on an observable price offered to other comparable customers. 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. The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company estimates related variable consideration at the point of sale, including discounts, product returns, refunds, and other similar obligations. Revenue is recognized over time when the customer simultaneously receives and consumes the benefits provided by the Company’s performance. Revenue is recognized at a point in time if the criteria for recognizing revenue over time are not met, and the Company has transferred control of the goods to the customer. Product revenue is recognized at a point in time when the Company has transferred control to the customer, which is generally when title of the goods transfers to the customer. Software is licensed via delivery to the customer or via a service arrangement under which cloud-based access is provided on a subscription basis (software-as-a-service). When a fixed up-front license fee is received in exchange for the delivery of software, revenue is recognized at the point in time when the delivery of the software has occurred. When software is licensed on a subscription basis, revenue is recognized over the respective license period. The Company also sells extended service contracts on its GentleWave Systems. Sales of extended service contracts are recorded as deferred revenue until such time as the standard warranty expires, which is generally up to two years from the date of sale. Service contract revenue is recognized on a straight-line basis over time consistent with the life of the related service contract in proportion to the costs incurred in fulfilling performance obligations under the service contract. Revenue for technical support and other services is recognized ratably over the performance obligation period. The Company generally does not experience returns. If necessary, a provision is recorded for estimated sales returns and allowances and is deducted from gross product revenue to arrive at net product revenue in the period the related revenue is recorded. These estimates are based on historical sales returns and allowances and other known factors. Actual returns and claims in any future period are inherently uncertain and thus may differ from these estimates. If actual or expected future returns and claims are significantly greater or lower than the reserves established, a reduction or increase to revenue will be recorded in the period in which such a determination is made. All non-income government-assessed taxes (sales and use taxes) collected from the Company’s customers and remitted to governmental agencies are recorded in accrued expenses until they are remitted to the government agency. 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. Contract liabilities The Company recognizes a contract liability when a customer pays for goods or services for which the Company has not yet transferred control. The balances of the Company’s contract liabilities are as follows: September 30, December 31, 2023 2022 (in thousands) Extended service contracts $ 629 $ 336 Subscription software licenses 169 481 Total contract liabilities 798 817 Less: long-term portion 221 — Contract liabilities – current $ 577 $ 817 Contract liabilities are included within other current liabilities and other long-term liabilities in the accompanying unaudited condensed consolidated balance sheets. Revenue recognized for each of the nine months ended September 30, 2023 and 2022 that was included in the contract liability balance as of December 31, 2022 and 2021 was $ 0.8 million . Disaggregation of revenue The Company disaggregates revenue from contracts with customers by segment and by the timing of when goods and services are transferred, which depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected. The following table provides information regarding revenues disaggregated by segment and the timing of when goods and services are transferred: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Product revenue recognized at a point in time $ 7,934 $ 7,616 $ 25,075 $ 22,909 Product revenue recognized over time 229 179 529 531 Software revenue recognized at a point in time 507 469 1,573 1,233 Software revenue recognized over time 1,736 1,582 4,996 4,753 Total $ 10,406 $ 9,846 $ 32,173 $ 29,426 No individual customer accounted for more than 10% of sales for the nine months ended September 30, 2023 and 2022. Warranty Reserve The Company provides a standard warranty on its GentleWave Systems for a specified period of time. For the nine months ended September 30, 2023 and 2022, GentleWave Systems sold were covered by the warranty for a period of up to two years from the date of sale. Estimated warranty costs are recorded as a liability at the time of delivery with a corresponding provision to cost of sales. Warranty accruals are estimated based on the current product costs, the Company’s historical experience, management’s expectations of future conditions and standard maintenance schedules. The Company evaluates this reserve on a regular basis and makes adjustments as necessary. The following table provides a reconciliation of the change in estimated warranty liabilities for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Balance at beginning of period $ 1,579 $ 1,730 $ 1,930 $ 1,620 Provision for warranties issued 170 328 570 1,108 Warranty costs incurred ( 384 ) ( 350 ) ( 1,135 ) ( 1,020 ) Balance at end of period $ 1,365 $ 1,708 $ 1,365 $ 1,708 Current portion $ 1,228 $ 1,212 Non-current portion 137 496 Total $ 1,365 $ 1,708 The warranty liability, current and non-current, are included in other current liabilities and other liabilities, respectively, on the unaudited condensed consolidated balance sheets. Recent Accounti ng Pronouncements Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements. Accounting Pronouncement Recently Adopted In October 2021, the FASB, issued Accounting Standards Update No. 2021-08, Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires an entity (acquirer) to recognize and measure contract assets and liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. This update is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years, with early adoption permitted. The amendments should be applied prospectively to business combinations occurring on or after the effective date of the amendments. The Company early adopted the ASU on January 1, 2023 . The adoption did no t have an impact on the Company's unaudited condensed consolidated financial statements. The Company will evaluate the impact for each business combination transaction completed hereafter. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 3. Balance Sheet Components Inventory Inventory consisted of the following: September 30, December 31, 2023 2022 (in thousands) Raw materials $ 6,733 $ 9,269 Work in process 569 427 Finished goods 4,140 5,766 Total inventory $ 11,442 $ 15,462 During the nine months ended September 30, 2023, the Company recorded a reserve for excess and obsolete inventory of $ 1.7 million related to reduced sales volumes of legacy GentleWave Console ( “Gen3” ). During the same period, the Company also recorded a charge of $ 1.2 million related to phasing out legacy procedure instruments, the molar and anterior pre-molar as the Company moves to the CleanFlow procedure instruments, of which $ 0.6 million was due to excess and obsolete inventory. As of September 30, 2023 and December 31, 2022, the balance of the reserve of excess and obsolete inventory was $ 1.9 million and $ 0.5 million, respectively. Intangible assets, net Intangible assets as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 Weighted Average Amortization Period Gross Accumulated Net (in years) (in thousands) Developed technology ( 5 - 10 years) 1.6 $ 1,110 $ 1,101 $ 9 Customer relationships ( 7 years) 4 1,910 1,353 557 Tradenames ( 10 years) 1.1 360 178 182 Total intangible assets 6.7 $ 3,380 $ 2,632 $ 748 December 31, 2022 Weighted Average Amortization Period Gross Accumulated Net (in years) (in thousands) Developed technology ( 5 - 10 years) 4.0 $ 2,445 $ 1,123 $ 1,322 Customer relationships ( 7 years) 2.8 1,910 1,148 762 Tradenames ( 10 years) 0.8 360 152 208 Total intangible assets 7.6 $ 4,715 $ 2,423 $ 2,292 During the three months ended September 30, 2023, an impairment charge of $ 1.0 million to developed technology was recorded in operating expenses on the condensed consolidated statements of operations and comprehensive loss. See Note 2 Summary of Accounting Policies and Recent Accounting Pronouncements for more information. Amortization expense was $ 0.2 million, which was mostly recorded in selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss for each of the three months ended September 30, 2023 and 2022. Amortization expense was $ 0.5 million for each of the nine months ended September 30, 2023 and 2022, with approximately $ 0.2 million amortization expense recorded in cost of sales and $ 0.3 million recorded in selling, general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations and comprehensive loss. The following table presents estimated future annual amortization expense related to intangible assets, net as of September 30, 2023: Future Intangible Asset Amortization Expenses (in thousands) 2023 (remaining three months) $ 86 2024 309 2025 252 2026 36 2027 and thereafter 65 Total future amortization expense $ 748 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments The Company applies fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company’s financial instruments consist principally of cash, cash equivalents, short-term investments, accounts receivable, accounts payable, operating lease liabilities, warrant liabilities and a term loan. Fair value is measured as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A fair value measurement assumes that the transaction to sell the asset or transfer the liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market. 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 the Company has the ability to access. Level 2 – Inputs (other than quoted prices included within Level 1) that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. Level 3 – Unobservable inputs that are significant to the fair value measurement and reflect the reporting entity’s use of significant management judgment and assumptions when there is little or no market data. 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 periods presented. The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, and certain accrued expenses approximate fair value due to the short-term nature of these items. Accordingly, the Company estimates that the recorded amounts approximate fair market value. The following table provides the 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 value at September 30, 2023 and December 31, 2022: September 30, 2023 Fair Value Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs (in thousands) Assets: Cash equivalents: Money market funds $ 10,635 $ 10,635 $ — $ — Total cash equivalents at fair value 10,635 10,635 — — Short-term investments: U.S. treasury securities 20,538 20,538 — — Commercial paper and corporate bonds 14,549 — 14,549 — U.S. government agency bonds 8,762 — 8,762 — Total short-term investments at fair value 43,849 20,538 23,311 — Total assets at fair value $ 54,484 $ 31,173 $ 23,311 $ — September 30, 2023 Fair Cost Amounts Recognized in Accumulated Other Comprehensive Loss Unrealized Gains Unrealized Losses (in thousands) Available-for-sale securities: U.S. treasury securities $ 20,538 $ 20,540 $ 1 $ ( 3 ) Commercial paper and corporate bonds 14,549 14,549 — - U.S. government agency bonds 8,762 8,766 — ( 4 ) Total available-for-sale securities at fair value $ 43,849 $ 43,855 $ 1 $ ( 7 ) December 31, 2022 Fair Value Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs (in thousands) Assets: Cash equivalents: Money market funds $ 12,253 $ 12,253 $ — $ — Commercial paper 1,998 — 1,998 — U.S. government agency bonds 1,991 — 1,991 — Total cash equivalents at fair value 16,242 12,253 3,989 — Short-term investments: U.S. treasury securities 33,622 33,622 — — Commercial paper and corporate bonds 40,162 — 40,162 — Total short-term investments at fair value 73,784 33,622 40,162 — Total assets at fair value $ 90,026 $ 45,875 $ 44,151 $ — December 31, 2022 Fair Cost Amounts Recognized in Accumulated Other Comprehensive Loss Unrealized Gains Unrealized Losses (in thousands) Available-for-sale securities: U.S. treasury securities $ 33,622 $ 33,676 $ — $ ( 54 ) Commercial paper and corporate bonds 40,162 40,169 — ( 7 ) Total available-for-sale securities at fair value $ 73,784 $ 73,845 $ — $ ( 61 ) Money market funds and U.S. Treasury securities are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. Commercial paper, U.S. government agency bonds and corporate bonds are measured at fair value using Level 2 inputs. The Company reviews trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from third party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 5. Stockholders’ Equity Warrants In April 2022, the Company amended its term loan and the warrants previously issued to Perceptive Credit Holdings III, LP (“Perceptive”) and certain of its affiliates to purchase an aggregate of 304,105 shares of its common stock. Such warrants were amended solely to reduce the exercise price of the warrants to $ 12.00 per share. Warrants issued and outstanding at September 30, 2023 and December 31, 2022 included 27,397 warrants with an exercise price of $ 10.95 per share and 304,106 warrants with an exercise price of $ 12.00 per share in each period. These warrants expire between December 2023 and August 2031 . On September 27, 2022, the Company completed the Private Placement, issuing an aggregate of approximately 23.0 million shares of its common stock at a purchase price of $ 0.95 per share and pre-funded warrants to purchase an aggregate of 43.3 million shares of common stock at a purchase price of $ 0.949 per pre-funded warrant to certain institutional investors and accredited investors (the “Purchasers”). The pre-funded warrants have an exercise price of $ 0.001 per share of common stock, are immediately exercisable and will remain exercisable until exercised in full. The aggregate net proceeds from the Private Placement, after deducting placement agent fees and other offering expenses, were $ 59.0 million. The pre-funded warrants include a provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than 9.99 % of the Company's common stock. The threshold is subject to the Purchaser's rights under the pre-funded warrant to increase or decrease such percentage to any other percentage not in excess of 19.99 % upon at least 61 days' prior notice from the Purchaser to the Company. As of September 30, 2023, approximately 1.8 million shares have been issued pursuant to the exercise of pre-funded warrants and 41.5 million shares underlying the pre-funded warrants remain outstanding. The pre-funded warrants are classified as equity and are accounted for as a component of additional paid-in capital at the time of issuance. The pre-funded warrants are included in the calculation of basic and diluted loss per share. Pursuant to the terms and conditions of the purchase agreements entered into by the Purchasers, the Company was obligated to file a registration statement with the SEC registering the resale by the Purchasers of the shares of common stock issued to them in the Private Placement and the shares of common stock to be issued to them upon exercise of the pre-funded warrants issued to them in the Private Placement within 45 days of the closing of the Private Placement. On November 4, 2022, the Company filed a registration statement on Form S-3 (File No. 333-268174), as required under the purchase agreements, and the registration statement was declared effective by the SEC on November 16, 2022. |
Stock Based Compensation
Stock Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Based Compensation | 6. Stock Based Compensation Stock-based Compensation Expenses The following tables present the Company's stock-based compensation for stock-settled awards by type (i.e., stock options and restricted stock units (“RSUs”)) granted under the Company's incentive plans, and rights to purchase shares of common stock issued under the Company's Employee Stock Purchase Plan (“ESPP”) and financial statement lines included in the accompanying unaudited condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 (in thousands) Options $ 645 $ 779 $ 2,233 $ 2,579 RSUs 1,094 905 3,389 2,440 ESPP 45 39 163 52 Total stock-based compensation expense $ 1,784 $ 1,723 $ 5,785 $ 5,071 Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 (in thousands) Cost of sales $ 55 $ 123 $ 294 $ 364 Selling, general and administrative 1,584 1,435 4,927 3,820 Research and development 145 165 564 887 Total stock-based compensation expense $ 1,784 $ 1,723 $ 5,785 $ 5,071 Compensation cost related to unvested stock options and RSUs will generally be amortized on a straight-line basis over the remaining average service period. T he following table presents the unamortized compensation cost and weighted average service period of all unvested outstanding awards as of September 30, 2023. Unamortized Compensation Costs Weighted Average Service Period (in thousands) (years) Options $ 3,422,242 1.71 RSUs 10,341,736 2.8 Total unamortized compensation cost $ 13,763,978 Plan Activities T he following table summarizes stock option activity under the Company's incentive plans: Number Weighted Weighted- Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Options outstanding, December 31, 2022 2,756,368 $ 2.83 $ 1,510 Granted 195,120 $ 1.08 Forfeited ( 320,299 ) $ 2.35 Expired ( 99,156 ) $ 1.14 $ 9 Options outstanding, September 30, 2023 2,532,033 $ 2.83 6.6 $ — Options vested and exercisable, September 30, 2023 1,839,527 $ 2.70 6.0 $ — Vested and expected to vest after September 30, 2023 2,474,615 $ 2.80 6.6 $ — The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2023 and 2022 was $ 0.83 and $ 1.16 per share, respectively. The following table summarizes the non-vested stock options that were outstanding as of September 30, 2023 and December 31, 2022: Number of Shares Weighted Non-vested Options, December 31, 2022 1,118,088 $ 6.23 Non-vested Options, September 30, 2023 692,506 $ 6.33 The total fair value of shares vested during the nine months ended September 30, 2023 and 2022 was $ 2.1 million and $ 2.6 million , respectively, in each period. Certain stock option grants under the 2017 Stock Incentive Plan (the “2017 Plan”) allow the recipient to exercise the options prior to the options becoming fully vested. Under the 2017 Plan, the Company retains the right to repurchase shares of its common shares that have been issued upon early exercise of options at the original issue price. During the three and nine months ended September 30, 2023, the Company did not repurchase any shares. There was no material number of shares of common stock subject to repurchase as of September 30, 2023. Cash received for the early exercise of unvested stock options is initially recorded as a liability and released to equity over the vesting period. There were no early exercised stock options during the three and nine months ended September 30, 2023. During the three and nine months ended September 30, 2022, early exercised stock options vested were immaterial. T he following table summarizes RSU activity under the Company's incentive plans: Number Weighted RSUs outstanding, December 31, 2022 2,858,649 $ 4.49 Granted 3,541,198 $ 1.57 Vested ( 1,164,429 ) $ 3.36 Forfeited ( 608,359 ) $ 3.45 RSUs outstanding, September 30, 2023 4,627,059 $ 2.68 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 7. Leases The Company leases office space under operating leases with expirations ranging from March 2025 to December 2026, some of which include rent escalations or an option to extend the lease for up to three years per renewal. The exercise of lease renewal options is at the sole discretion of the Company. As of September 30, 2023 , the Company has not entered into any leases that have not yet commenced that would entitle the Company to significant rights or create additional obligations. The Company determines whether a contract is or contains a lease at the inception of the contract. A contract will be deemed to be or contain a lease if the contract conveys the right to control and direct the use of identified property, plant, or equipment for a period of time in exchange for consideration. The Company generally must also have the right to obtain substantially all of the economic benefits from the use of the property, plant, and equipment. The Company has elected the practical expedient to not separate its lease component from non-lease component for its real estate leases. The Company has elected the practical expedient not to apply the lease recognition requirements to short-term leases with an initial term of 12 months or less. The Company uses either its incremental borrowing rate or the implicit rate in the lease agreement as the basis to calculate the present value of future lease payments at lease commencement. The incremental borrowing rate represents the rate the Company would have to pay to borrow funds on a collateralized basis over a similar term and in a similar economic environment. Future minimum lease payments under these leases are as follows: Lease Amounts (in thousands) 2023 (remaining three months) $ 251 2024 1,555 2025 1,010 2026 645 Total future minimum lease payments 3,461 Less: Imputed Interest ( 345 ) Present value of operating lease liabilities $ 3,116 Less: Current portion 1,334 Long-term operating lease liabilities $ 1,782 Weighted average remaining lease term in years 2.54 Weighted average discount rate 8.81 % Variable operating lease expenses consist primarily of real estate taxes and insurance. The components of lease expense and related cash flows were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Rent expense $ 373 $ 319 $ 1,140 $ 956 Variable lease costs 17 26 81 79 Total $ 390 $ 345 $ 1,221 $ 1,035 Cash paid for operating leases $ 382 $ 321 $ 1,140 $ 951 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) (in thousands) Cost of sales $ 67 $ 58 $ 205 $ 174 Selling, general and administrative 323 287 1,016 861 Total $ 390 $ 345 $ 1,221 $ 1,035 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Contingencies The Company is subject to claims and assessments from time to time 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 accompanying unaudited condensed 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. The Company’s management does not believe that any such matters, individually or in aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows. Listing Notice from NYSE In late September 2023, the Company’s share price had fallen below the NYSE's listing standard threshold and therefore the Company received notice of non-compliance from the NYSE. As required by the NYSE, we notified the NYSE of our plan to cure and restore our compliance with the NYSE's continued listing standard no later than our next annual meeting, currently schedule no later than June 2024. There is no assurance that we will cure and restore our compliance or, if cured and restored, remain in compliance with such requirement or other NYSE continued listing standards in the future. |
Term Loan
Term Loan | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Term Loan | 9. Term Loan Perceptive loan On April 6, 2022, the Company entered into Amendment No. 1 (the “First Amendment”) to the Amended and Restated Credit Agreement and Guaranty with Perceptive (the “Perceptive Loan Agreement” ). The First Amendment extended the borrowing deadline for the first tranche of $ 10.0 million of delayed-draw term loans from December 31, 2021 to September 30, 2022 and the borrowing deadline for the second tranche of $ 10.0 million delayed-draw term loans from March 31, 2022 to June 30, 2023 . The Company borrowed the extended first tranche of $ 10.0 million in July 2022, receiving net proceeds of $ 9.9 million, and forfeited the extended second tranche on June 30, 2023. As a condition to entering into the First Amendment, on April 6, 2022, the Company also amended the warrants previously issued to Perceptive and certain of its affiliates to purchase an aggregate of 304,105 shares of its common stock. Such warrants were amended solely to reduce the exercise price of the warrants to $ 12.00 per share. In August 2022, a portion of these warrants representing 153,421 shares were transferred to a third party and its affiliates. For the nine months ended September 30, 2023 and 2 022, the interest rate for amounts borrowed under the Perceptive Loan Agreement, as amended, was the greater of the one-month LIBOR and 2.00 % plus the applicable margin of 9.25 %. On January 13, 2023, the Company entered into Amendment No. 2 (the “ Second Amendment ” ) to the Perceptive Loan Agreement to replace the existing benchmark rate from the one-month LIBOR with a one-month Secured Overnight Financing Rate ( “ SOFR ” ). All other terms remain unchanged in the Perceptive Loan Agreement. For the nine months ended September 30, 2023 and 2022 , the effective interest rate of the Perceptive loan was 17.39 % and 14.31 %, respectively. As of September 30, 2023 and 2022, the fair value of the Perceptive loan approximates its carrying amount. Future principal repayments on the Perceptive Loan Agreement as of September 30, 2023 , are as follows: Principal (in thousands) 2026 $ 40,000 Total $ 40,000 The Perceptive Loan Agreement, as amended, contains events of default, including, without limitation, upon: (i) failure to make a payment pursuant to the terms of the agreement; (ii) violation of certain covenants; (iii) payment or other defaults on other indebtedness; (iv) material adverse change in the business or change in control; (v) insolvency; (vi) significant judgments; (vii) incorrectness of representations and warranties; (viii) regulatory matters; and (ix) failure by us to maintain a valid and perfected lien on the collateral securing the borrowing. The Perceptive Loan Agreement, as amended, includes financial covenants that require the Company to (i) maintain, at all times, a minimum aggregate balance of $ 3.0 million in cash in one or more controlled accounts, and (ii) satisfy certain minimum revenue thresholds, measured for the consecutive 12-month periods ending on each calendar quarter-end until June 30, 2026. These thresholds progressively increase over time, ranging from $ 26.4 million for the consecutive 12-month periods ending September 30, 2021 to $ 95.3 million for the consecutive 12-month periods ending June 30, 2026. Specifically, the minimum revenue thresholds for the consecutive 12-months period ending on September 30, 2024 and December 31, 2024, are $ 52.0 million and $ 58.6 mil lion, respectively. Failure to satisfy these covenants would constitute an event of default under the agreement, as amended. In the event of an event of default, the lender may terminate its commitments and declare all amounts outstanding under the Perceptive Loan Agreement, as amended, immediately due and payable, together with accrued interest and all fees and other obligations. The amount of such repayment will include payment of any prepayment premium applicable due to the time of such payment. In addition, upon the occurrence and during the continuance of any event of default, the applicable margin will increase by 3.00 % per annum to 12.25 %. As of September 30, 2023, we were in compliance with all covenants and conditions required by the outstanding Perceptive Loan Agreement, as amended . |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes The Company maintains a full valuation allowance against its net deferred tax assets as of September 30, 2023 based on the current assessment that it is not more likely than not these future benefits will be realized before expiration. No material income tax expense or benefit has been recorded given the valuation allowance position and projected taxable losses in the jurisdictions where the Company files income tax returns. The Company has not experienced any significant increases or decreases to its unrecognized tax benefits since December 31, 2022 and does not expect any within the next 12 months. The Company monitors changes to the tax laws in the states it conducts business and files corporate income tax returns. Utilization of the net operating loss carryforwards may be subject to substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. The Company has not completed an analysis regarding the limitation of net operating loss and R&D credit carryforwards as of September 30, 2023. The Company is subject to U.S. federal and various states income taxes. The federal returns for tax y ears 2020 through 2022 remain open to examination and the state returns remain subject to examination for tax years 2019 through 2022 . Carryforward attributes that were generated in years where the statute of limitations is closed may still be adjusted upon examination by the Internal Revenue Service or other respective tax authorities. All other state jurisdictions remain open to examination. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Segment Information | 11. Segment Information The Company operates and reports its results in two business segments, Product and Software. The Company reports segment information based on the management approach. The management approach designates the internal reporting used by the Company's chief operating decision maker (“CODM”) for decision making and performance assessment as the basis for determining the Company’s reportable segments. The performance measures of the Company’s reportable segments are primarily income (loss) from operations. Income (loss) from operations for each segment includes all revenues, related cost of net revenues, gross margin and operating expenses directly attributable to the segment. The Company’s Product segment includes sales of the Company's GentleWave System console and related accessories and instruments. The Company’s Software segment includes sales of the Company's traditional software licenses for practice management software to enable an integrated digital office for endodontists. The following tables present the Company’s segment information for the three and nine months ended September 30, 2023 and 2022. In the Product segment, for the three months ended September 30, 2023, the Company recognized a total impairment charge of $ 3.4 million for long lived assets, of which, $ 1.3 million was recorded in cost of sales and the remainder in operating expenses. For the nine months ended September 30, 2023, in addition to the impairment charges, cost of sales included a $ 2.9 million charge related to inventory in the second quarter of 2023 due to reduced sales of our legacy GentleWave Console ( “ Gen 3 ” ) and the phase-out of our molar and pre-molar legacy procedure instruments. Three months ended September 30, Three months ended September 30, 2023 2022 (in thousands, except percentage data) Product Software Total Product Software Total Revenue $ 8,163 $ 2,243 $ 10,406 $ 7,795 $ 2,051 $ 9,846 Cost of sales: Product and software 5,938 681 6,619 6,875 653 7,528 Impairment of long-lived assets 1,341 — 1,341 — — — Total cost of sales 7,279 681 7,960 6,875 653 7,528 Gross profit 884 1,562 2,446 920 1,398 2,318 Gross margin 11 % 70 % 24 % 12 % 68 % 24 % Operating expenses: Selling, general and administrative 12,847 595 13,442 12,141 445 12,586 Research and development 2,551 498 3,049 3,891 437 4,328 Impairment of long-lived assets 2,051 — 2,051 — — — Total operating expenses 17,449 1,093 — 18,542 16,032 882 16,914 Income (loss) from operations $ ( 16,565 ) $ 469 $ ( 16,096 ) $ ( 15,112 ) $ 516 $ ( 14,596 ) Nine months ended September 30, Nine months ended September 30, 2023 2022 (in thousands, except percentage data) Product Software Total Product Software Total Revenue $ 25,604 $ 6,569 $ 32,173 $ 23,440 $ 5,986 $ 29,426 Cost of sales: Product and software 21,886 2,056 23,942 20,338 1,938 22,276 Impairment of long-lived assets 1,341 — 1,341 — — — Total cost of sales 23,227 2,056 25,283 20,338 1,938 22,276 Gross profit 2,377 4,513 6,890 3,102 4,048 7,150 Gross margin 9 % 69 % 21 % 13 % 68 % 24 % Operating expenses: Selling, general and administrative 41,070 1,789 42,859 35,911 1,482 37,393 Research and development 8,242 1,599 9,841 11,874 1,322 13,196 Impairment of long-lived assets 2,051 — 2,051 — — — Total operating expenses 51,363 3,388 54,751 47,785 2,804 50,589 Income (loss) from operations $ ( 48,986 ) $ 1,125 $ ( 47,861 ) $ ( 44,683 ) $ 1,244 $ ( 43,439 ) Segment Assets: As of September 30, 2023 As of December 31, 2022 (in thousands) Product $ 77,446 $ 125,713 Software 10,881 11,572 Total $ 88,327 $ 137,285 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented: Three months ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands, except shares and per share data) (in thousands, except shares and per share data) Numerator: Net loss $ ( 16,980 ) $ ( 15,539 ) $ ( 50,041 ) $ ( 46,198 ) Denominator: Weighted-average shares outstanding – basic and diluted 94,286,107 33,116,536 93,790,557 28,688,018 Net loss per share – basic and diluted $ ( 0.18 ) $ ( 0.47 ) $ ( 0.53 ) $ ( 1.61 ) The pre-funded warrants to purchase an aggregate of 43.3 million shares of common stock are considered outstanding for the purposes of computing loss per share and are included in the calculation of basic and diluted shares outstanding above. The following potentially dilutive securities were excluded from the computation of diluted net loss per share calculations for the periods presented because the impact of including them would be anti-dilutive: Nine Months Ended September 30, 2023 2022 Stock options 2,532,033 2,985,032 RSUs 4,627,059 2,935,934 Warrants 331,503 331,503 Total 7,490,595 6,252,469 |
Summary Accounting Policies a_2
Summary Accounting Policies and Recent Accounting Pronouncements (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates, judgements and assumptions that affect the reported amounts in the unaudited condensed consolidated financial statements and disclosures in the accompanying notes, including estimates of probable losses and expenses, as of the date of the accompanying unaudited condensed consolidated financial statements. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of these unaudited condensed consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying unaudited condensed consolidated financial statements under different assumptions or conditions. |
Inventory | Inventory Inventory consists of finished products, work-in-process and raw materials and is valued at the lower of cost or net realizable value. Cost may include materials, labor and manufacturing overhead. Cost is determined by the first in, first out inventory method. The carrying value of inventory is reviewed for potential impairment whenever indicators suggest that the cost of inventory exceeds the carrying value and management adjusts the inventory to its net realizable value. The Company also periodically evaluates inventory for estimated losses from excess quantities and obsolescence and writes down the cost of inventory 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 of completion and disposal. |
Long-Lived Assets | Long-Lived Assets The Company reviews its long-lived assets, which includes definite-lived intangibles, long-lived fixed assets and lease right-of-use assets, for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Factors that could trigger an impairment review include significant under-performance relative to expected historical or projected future operating results, significant changes in the manner of the Company’s use of the acquired assets or the strategy for the Company’s overall business or significant negative industry or economic trends. If this evaluation indicates that the value of the long-lived asset may be impaired, the Company makes an assessment of the recoverability of the net carrying value of the asset over its remaining useful life. If this assessment indicates that the long-lived asset is not recoverable, based on the estimated undiscounted future cash flows of the technology over the remaining useful life, the Company reduces the net carrying value of the related asset to fair value and may adjust the remaining useful life. An impairment analysis is subjective and assumptions regarding future growth rates and operating expense levels can have a significant impact on the expected future cash flows and impairment analysis. In the third quarter of 2023, the significant decline in the Company's market capitalization was a triggering event, which resulted in the performance of an interim long-lived assets impairment assessment. The interim assessment indicated that the carrying amount of the Company's definite-lived intangible and long-lived fixed assets in its Product segment would not be recoverable. As a result , the Company recognized an impairment charge of $ 1.0 million to a definite-lived intangible, developed technology, which was recorded in operating expenses on the Condensed Consolidated Statements of Operations , and an impairment charge of $ 2.3 million to property and equipment, of which, $ 1.3 million was recorded in cost of sales and the remainder was recorded in operating expenses on the Condensed Consolidated Statements of Operations . No impairment of lease right-of-use assets was recognized as the fair value of the lease right-of-use assets exceeds their carrying amount. |
Goodwill | Goodwill Goodwill represents the excess of cost over fair value of identified assets acquired and liabilities assumed by the Company in an acquisition of a business. The determination of the value of goodwill and intangible assets arising from a business combination requires extensive use of accounting estimates and judgments to allocate the purchase price to the fair value of the net tangible and intangible assets acquired. The Company recorded $ 8.5 million of goodwill in conjunction with the acquisition of TDO. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. The Company performs its annual impairment analysis by either comparing a reporting unit’s estimated fair value to its carrying amount or doing a qualitative assessment of a reporting unit’s fair value from the last quantitative assessment to determine if there is potential impairment. The Company may do a qualitative assessment when the results of the previous quantitative test indicated the reporting unit’s estimated fair value was significantly in excess of the carrying value of its net assets and it does not believe there have been significant changes in the reporting unit’s operations that would significantly decrease its estimated fair value or significantly increase its net assets. If a quantitative assessment is performed, the evaluation includes management projections of future cash flows and/or use of a market approach by considering market values of comparable companies. Key assumptions for these projections include revenue growth, future gross and operating margin growth, and the weighted cost of capital and terminal growth rates. Revenue and margin growth are based on increased sales of new and existing products as the Company maintains investments in research and development. Additional value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation. The Company’s annual evaluation for impairment of goodwill consists of the software reporting unit from which the goodwill originated. The Company's annual goodwill testing is determined to be performed as of October 31. However, given the significant decline in the Company's market capitalization in the third quarter of 2023, the Company completed an evaluation for impairment as of September 30, 2023, using a quantitative assessment and determined that no impairment existed. The assumptions used in the estimate of fair value are generally consistent with the past performance of the Company and are also consistent with the projections and assumptions that are used in current operating plans. The assumptions are subject to change as a result of changing economic and competitive conditions. |
Revenue Recognition | Revenue Recognition Contracts with Customers The Company recognizes revenue when it transfers promised goods or services to customers in an amount 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 core principles 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. Product revenue is generated from sales of the GentleWave Console and related PIs and accessories. Software revenue is generated from sales of TDO's endodontist practice management software licenses. The Company’s products are sold primarily in the United States and Canada directly to customers through its field sales force. Performance Obligations The Company’s performance obligations primarily arise from the manufacture and delivery of the GentleWave System, related PIs and accessories, and the delivery or license of TDO software and related ancillary services. Payment terms are typically on open credit terms consistent with industry practice and do not have significant financing components. Consideration may be variable based on volume. The Company considers the individual deliverables in its product offering as separate performance obligations and assesses whether each promised good or service is distinct. The total contract transaction price is determined based on the consideration expected to be received, based on the stated value in contractual arrangements or the estimated cash to be collected in no-contracted arrangements, and is allocated to the identified performance obligations based upon the relative standalone selling prices of the performance obligations. The stand-alone selling price is based on an observable price offered to other comparable customers. 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. The consideration the Company receives in exchange for its goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration. The Company estimates related variable consideration at the point of sale, including discounts, product returns, refunds, and other similar obligations. Revenue is recognized over time when the customer simultaneously receives and consumes the benefits provided by the Company’s performance. Revenue is recognized at a point in time if the criteria for recognizing revenue over time are not met, and the Company has transferred control of the goods to the customer. Product revenue is recognized at a point in time when the Company has transferred control to the customer, which is generally when title of the goods transfers to the customer. Software is licensed via delivery to the customer or via a service arrangement under which cloud-based access is provided on a subscription basis (software-as-a-service). When a fixed up-front license fee is received in exchange for the delivery of software, revenue is recognized at the point in time when the delivery of the software has occurred. When software is licensed on a subscription basis, revenue is recognized over the respective license period. The Company also sells extended service contracts on its GentleWave Systems. Sales of extended service contracts are recorded as deferred revenue until such time as the standard warranty expires, which is generally up to two years from the date of sale. Service contract revenue is recognized on a straight-line basis over time consistent with the life of the related service contract in proportion to the costs incurred in fulfilling performance obligations under the service contract. Revenue for technical support and other services is recognized ratably over the performance obligation period. The Company generally does not experience returns. If necessary, a provision is recorded for estimated sales returns and allowances and is deducted from gross product revenue to arrive at net product revenue in the period the related revenue is recorded. These estimates are based on historical sales returns and allowances and other known factors. Actual returns and claims in any future period are inherently uncertain and thus may differ from these estimates. If actual or expected future returns and claims are significantly greater or lower than the reserves established, a reduction or increase to revenue will be recorded in the period in which such a determination is made. All non-income government-assessed taxes (sales and use taxes) collected from the Company’s customers and remitted to governmental agencies are recorded in accrued expenses until they are remitted to the government agency. 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. Contract liabilities The Company recognizes a contract liability when a customer pays for goods or services for which the Company has not yet transferred control. The balances of the Company’s contract liabilities are as follows: September 30, December 31, 2023 2022 (in thousands) Extended service contracts $ 629 $ 336 Subscription software licenses 169 481 Total contract liabilities 798 817 Less: long-term portion 221 — Contract liabilities – current $ 577 $ 817 Contract liabilities are included within other current liabilities and other long-term liabilities in the accompanying unaudited condensed consolidated balance sheets. Revenue recognized for each of the nine months ended September 30, 2023 and 2022 that was included in the contract liability balance as of December 31, 2022 and 2021 was $ 0.8 million . Disaggregation of revenue The Company disaggregates revenue from contracts with customers by segment and by the timing of when goods and services are transferred, which depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected. The following table provides information regarding revenues disaggregated by segment and the timing of when goods and services are transferred: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Product revenue recognized at a point in time $ 7,934 $ 7,616 $ 25,075 $ 22,909 Product revenue recognized over time 229 179 529 531 Software revenue recognized at a point in time 507 469 1,573 1,233 Software revenue recognized over time 1,736 1,582 4,996 4,753 Total $ 10,406 $ 9,846 $ 32,173 $ 29,426 No individual customer accounted for more than 10% of sales for the nine months ended September 30, 2023 and 2022. |
Warranty Reserve | Warranty Reserve The Company provides a standard warranty on its GentleWave Systems for a specified period of time. For the nine months ended September 30, 2023 and 2022, GentleWave Systems sold were covered by the warranty for a period of up to two years from the date of sale. Estimated warranty costs are recorded as a liability at the time of delivery with a corresponding provision to cost of sales. Warranty accruals are estimated based on the current product costs, the Company’s historical experience, management’s expectations of future conditions and standard maintenance schedules. The Company evaluates this reserve on a regular basis and makes adjustments as necessary. The following table provides a reconciliation of the change in estimated warranty liabilities for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Balance at beginning of period $ 1,579 $ 1,730 $ 1,930 $ 1,620 Provision for warranties issued 170 328 570 1,108 Warranty costs incurred ( 384 ) ( 350 ) ( 1,135 ) ( 1,020 ) Balance at end of period $ 1,365 $ 1,708 $ 1,365 $ 1,708 Current portion $ 1,228 $ 1,212 Non-current portion 137 496 Total $ 1,365 $ 1,708 The warranty liability, current and non-current, are included in other current liabilities and other liabilities, respectively, on the unaudited condensed consolidated balance sheets. |
Recent Accounting Pronouncements | Recent Accounti ng Pronouncements Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). ASUs not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements. Accounting Pronouncement Recently Adopted In October 2021, the FASB, issued Accounting Standards Update No. 2021-08, Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires an entity (acquirer) to recognize and measure contract assets and liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. This update is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years, with early adoption permitted. The amendments should be applied prospectively to business combinations occurring on or after the effective date of the amendments. The Company early adopted the ASU on January 1, 2023 . The adoption did no t have an impact on the Company's unaudited condensed consolidated financial statements. The Company will evaluate the impact for each business combination transaction completed hereafter. |
Summary Accounting Policies a_3
Summary Accounting Policies and Recent Accounting Pronouncements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Balances of Contract Liabilities | The Company recognizes a contract liability when a customer pays for goods or services for which the Company has not yet transferred control. The balances of the Company’s contract liabilities are as follows: September 30, December 31, 2023 2022 (in thousands) Extended service contracts $ 629 $ 336 Subscription software licenses 169 481 Total contract liabilities 798 817 Less: long-term portion 221 — Contract liabilities – current $ 577 $ 817 |
Schedule of Revenues Disaggregated by Segment and Timing of Goods and Services Transferred | The following table provides information regarding revenues disaggregated by segment and the timing of when goods and services are transferred: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Product revenue recognized at a point in time $ 7,934 $ 7,616 $ 25,075 $ 22,909 Product revenue recognized over time 229 179 529 531 Software revenue recognized at a point in time 507 469 1,573 1,233 Software revenue recognized over time 1,736 1,582 4,996 4,753 Total $ 10,406 $ 9,846 $ 32,173 $ 29,426 No individual customer accounted for more than 10% of sales for the nine months ended September 30, 2023 and 2022. |
Schedule of Reconciliation of Change in Estimated Warranty Liabilities | The following table provides a reconciliation of the change in estimated warranty liabilities for the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Balance at beginning of period $ 1,579 $ 1,730 $ 1,930 $ 1,620 Provision for warranties issued 170 328 570 1,108 Warranty costs incurred ( 384 ) ( 350 ) ( 1,135 ) ( 1,020 ) Balance at end of period $ 1,365 $ 1,708 $ 1,365 $ 1,708 Current portion $ 1,228 $ 1,212 Non-current portion 137 496 Total $ 1,365 $ 1,708 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: September 30, December 31, 2023 2022 (in thousands) Raw materials $ 6,733 $ 9,269 Work in process 569 427 Finished goods 4,140 5,766 Total inventory $ 11,442 $ 15,462 |
Schedule of Intangible Assets, Net | Intangible assets as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 Weighted Average Amortization Period Gross Accumulated Net (in years) (in thousands) Developed technology ( 5 - 10 years) 1.6 $ 1,110 $ 1,101 $ 9 Customer relationships ( 7 years) 4 1,910 1,353 557 Tradenames ( 10 years) 1.1 360 178 182 Total intangible assets 6.7 $ 3,380 $ 2,632 $ 748 December 31, 2022 Weighted Average Amortization Period Gross Accumulated Net (in years) (in thousands) Developed technology ( 5 - 10 years) 4.0 $ 2,445 $ 1,123 $ 1,322 Customer relationships ( 7 years) 2.8 1,910 1,148 762 Tradenames ( 10 years) 0.8 360 152 208 Total intangible assets 7.6 $ 4,715 $ 2,423 $ 2,292 |
Schedule of Estimated Future Annual Amortization Expense Related to Intangible Assets | The following table presents estimated future annual amortization expense related to intangible assets, net as of September 30, 2023: Future Intangible Asset Amortization Expenses (in thousands) 2023 (remaining three months) $ 86 2024 309 2025 252 2026 36 2027 and thereafter 65 Total future amortization expense $ 748 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table provides the 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 value at September 30, 2023 and December 31, 2022: September 30, 2023 Fair Value Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs (in thousands) Assets: Cash equivalents: Money market funds $ 10,635 $ 10,635 $ — $ — Total cash equivalents at fair value 10,635 10,635 — — Short-term investments: U.S. treasury securities 20,538 20,538 — — Commercial paper and corporate bonds 14,549 — 14,549 — U.S. government agency bonds 8,762 — 8,762 — Total short-term investments at fair value 43,849 20,538 23,311 — Total assets at fair value $ 54,484 $ 31,173 $ 23,311 $ — December 31, 2022 Fair Value Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs (in thousands) Assets: Cash equivalents: Money market funds $ 12,253 $ 12,253 $ — $ — Commercial paper 1,998 — 1,998 — U.S. government agency bonds 1,991 — 1,991 — Total cash equivalents at fair value 16,242 12,253 3,989 — Short-term investments: U.S. treasury securities 33,622 33,622 — — Commercial paper and corporate bonds 40,162 — 40,162 — Total short-term investments at fair value 73,784 33,622 40,162 — Total assets at fair value $ 90,026 $ 45,875 $ 44,151 $ — |
Summary of Short-Term Investments | September 30, 2023 Fair Cost Amounts Recognized in Accumulated Other Comprehensive Loss Unrealized Gains Unrealized Losses (in thousands) Available-for-sale securities: U.S. treasury securities $ 20,538 $ 20,540 $ 1 $ ( 3 ) Commercial paper and corporate bonds 14,549 14,549 — - U.S. government agency bonds 8,762 8,766 — ( 4 ) Total available-for-sale securities at fair value $ 43,849 $ 43,855 $ 1 $ ( 7 ) December 31, 2022 Fair Cost Amounts Recognized in Accumulated Other Comprehensive Loss Unrealized Gains Unrealized Losses (in thousands) Available-for-sale securities: U.S. treasury securities $ 33,622 $ 33,676 $ — $ ( 54 ) Commercial paper and corporate bonds 40,162 40,169 — ( 7 ) Total available-for-sale securities at fair value $ 73,784 $ 73,845 $ — $ ( 61 ) |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense | The following tables present the Company's stock-based compensation for stock-settled awards by type (i.e., stock options and restricted stock units (“RSUs”)) granted under the Company's incentive plans, and rights to purchase shares of common stock issued under the Company's Employee Stock Purchase Plan (“ESPP”) and financial statement lines included in the accompanying unaudited condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 (in thousands) Options $ 645 $ 779 $ 2,233 $ 2,579 RSUs 1,094 905 3,389 2,440 ESPP 45 39 163 52 Total stock-based compensation expense $ 1,784 $ 1,723 $ 5,785 $ 5,071 Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 (in thousands) Cost of sales $ 55 $ 123 $ 294 $ 364 Selling, general and administrative 1,584 1,435 4,927 3,820 Research and development 145 165 564 887 Total stock-based compensation expense $ 1,784 $ 1,723 $ 5,785 $ 5,071 |
Schedule of Unamortized Compensation Cost and Weighted Average Service Period of Unvested Outstanding Awards | T he following table presents the unamortized compensation cost and weighted average service period of all unvested outstanding awards as of September 30, 2023. Unamortized Compensation Costs Weighted Average Service Period (in thousands) (years) Options $ 3,422,242 1.71 RSUs 10,341,736 2.8 Total unamortized compensation cost $ 13,763,978 |
Summary of Stock Option Activity under Incentive Plans | T he following table summarizes stock option activity under the Company's incentive plans: Number Weighted Weighted- Average Remaining Contractual Life Aggregate Intrinsic Value (in years) (in thousands) Options outstanding, December 31, 2022 2,756,368 $ 2.83 $ 1,510 Granted 195,120 $ 1.08 Forfeited ( 320,299 ) $ 2.35 Expired ( 99,156 ) $ 1.14 $ 9 Options outstanding, September 30, 2023 2,532,033 $ 2.83 6.6 $ — Options vested and exercisable, September 30, 2023 1,839,527 $ 2.70 6.0 $ — Vested and expected to vest after September 30, 2023 2,474,615 $ 2.80 6.6 $ — |
Summary of Non Vested Stock Options | The following table summarizes the non-vested stock options that were outstanding as of September 30, 2023 and December 31, 2022: Number of Shares Weighted Non-vested Options, December 31, 2022 1,118,088 $ 6.23 Non-vested Options, September 30, 2023 692,506 $ 6.33 |
Summary of RSU Activity under Incentive Plans | T he following table summarizes RSU activity under the Company's incentive plans: Number Weighted RSUs outstanding, December 31, 2022 2,858,649 $ 4.49 Granted 3,541,198 $ 1.57 Vested ( 1,164,429 ) $ 3.36 Forfeited ( 608,359 ) $ 3.45 RSUs outstanding, September 30, 2023 4,627,059 $ 2.68 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments | Future minimum lease payments under these leases are as follows: Lease Amounts (in thousands) 2023 (remaining three months) $ 251 2024 1,555 2025 1,010 2026 645 Total future minimum lease payments 3,461 Less: Imputed Interest ( 345 ) Present value of operating lease liabilities $ 3,116 Less: Current portion 1,334 Long-term operating lease liabilities $ 1,782 Weighted average remaining lease term in years 2.54 Weighted average discount rate 8.81 % |
Components of Lease Expense and Related Cash Flows | The components of lease expense and related cash flows were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) Rent expense $ 373 $ 319 $ 1,140 $ 956 Variable lease costs 17 26 81 79 Total $ 390 $ 345 $ 1,221 $ 1,035 Cash paid for operating leases $ 382 $ 321 $ 1,140 $ 951 Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands) (in thousands) Cost of sales $ 67 $ 58 $ 205 $ 174 Selling, general and administrative 323 287 1,016 861 Total $ 390 $ 345 $ 1,221 $ 1,035 |
Term Loan (Tables)
Term Loan (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principal Repayments of Term Loan | Future principal repayments on the Perceptive Loan Agreement as of September 30, 2023 , are as follows: Principal (in thousands) 2026 $ 40,000 Total $ 40,000 |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment Reporting [Abstract] | |
Summary of Segment Information | The following tables present the Company’s segment information for the three and nine months ended September 30, 2023 and 2022. In the Product segment, for the three months ended September 30, 2023, the Company recognized a total impairment charge of $ 3.4 million for long lived assets, of which, $ 1.3 million was recorded in cost of sales and the remainder in operating expenses. For the nine months ended September 30, 2023, in addition to the impairment charges, cost of sales included a $ 2.9 million charge related to inventory in the second quarter of 2023 due to reduced sales of our legacy GentleWave Console ( “ Gen 3 ” ) and the phase-out of our molar and pre-molar legacy procedure instruments. Three months ended September 30, Three months ended September 30, 2023 2022 (in thousands, except percentage data) Product Software Total Product Software Total Revenue $ 8,163 $ 2,243 $ 10,406 $ 7,795 $ 2,051 $ 9,846 Cost of sales: Product and software 5,938 681 6,619 6,875 653 7,528 Impairment of long-lived assets 1,341 — 1,341 — — — Total cost of sales 7,279 681 7,960 6,875 653 7,528 Gross profit 884 1,562 2,446 920 1,398 2,318 Gross margin 11 % 70 % 24 % 12 % 68 % 24 % Operating expenses: Selling, general and administrative 12,847 595 13,442 12,141 445 12,586 Research and development 2,551 498 3,049 3,891 437 4,328 Impairment of long-lived assets 2,051 — 2,051 — — — Total operating expenses 17,449 1,093 — 18,542 16,032 882 16,914 Income (loss) from operations $ ( 16,565 ) $ 469 $ ( 16,096 ) $ ( 15,112 ) $ 516 $ ( 14,596 ) Nine months ended September 30, Nine months ended September 30, 2023 2022 (in thousands, except percentage data) Product Software Total Product Software Total Revenue $ 25,604 $ 6,569 $ 32,173 $ 23,440 $ 5,986 $ 29,426 Cost of sales: Product and software 21,886 2,056 23,942 20,338 1,938 22,276 Impairment of long-lived assets 1,341 — 1,341 — — — Total cost of sales 23,227 2,056 25,283 20,338 1,938 22,276 Gross profit 2,377 4,513 6,890 3,102 4,048 7,150 Gross margin 9 % 69 % 21 % 13 % 68 % 24 % Operating expenses: Selling, general and administrative 41,070 1,789 42,859 35,911 1,482 37,393 Research and development 8,242 1,599 9,841 11,874 1,322 13,196 Impairment of long-lived assets 2,051 — 2,051 — — — Total operating expenses 51,363 3,388 54,751 47,785 2,804 50,589 Income (loss) from operations $ ( 48,986 ) $ 1,125 $ ( 47,861 ) $ ( 44,683 ) $ 1,244 $ ( 43,439 ) |
Segment Assets | Segment Assets: As of September 30, 2023 As of December 31, 2022 (in thousands) Product $ 77,446 $ 125,713 Software 10,881 11,572 Total $ 88,327 $ 137,285 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted 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 for the periods presented: Three months ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (in thousands, except shares and per share data) (in thousands, except shares and per share data) Numerator: Net loss $ ( 16,980 ) $ ( 15,539 ) $ ( 50,041 ) $ ( 46,198 ) Denominator: Weighted-average shares outstanding – basic and diluted 94,286,107 33,116,536 93,790,557 28,688,018 Net loss per share – basic and diluted $ ( 0.18 ) $ ( 0.47 ) $ ( 0.53 ) $ ( 1.61 ) |
Summary of Potentially Dilutive Securities Excluded from the Computation of Diluted Net Loss Per Share | The following potentially dilutive securities were excluded from the computation of diluted net loss per share calculations for the periods presented because the impact of including them would be anti-dilutive: Nine Months Ended September 30, 2023 2022 Stock options 2,532,033 2,985,032 RSUs 4,627,059 2,935,934 Warrants 331,503 331,503 Total 7,490,595 6,252,469 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ / shares in Units, $ in Thousands, shares in Millions | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 27, 2022 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) Segment $ / shares shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares | |
Organization And Basis Of Presentation [Line Items] | ||||||||||
Warrant exercise price per share | $ / shares | $ 10.95 | $ 10.95 | $ 12 | |||||||
Proceeds from issuance of common stock net of underwriting discounts and commissions and other offering expenses | $ 20,623 | |||||||||
Cash and cash equivalents and short-term investments | $ 55,900 | $ 55,900 | ||||||||
Cash and cash equivalents | 12,090 | 12,090 | $ 17,665 | |||||||
Accumulated deficit | (419,135) | (419,135) | $ (369,094) | |||||||
Net loss | 16,980 | $ 17,690 | $ 15,371 | $ 15,539 | $ 15,137 | $ 15,522 | 50,041 | 46,198 | ||
Cash and cash equivalents used in operations | $ 36,557 | $ 46,826 | ||||||||
Payment of employee retention credit | 4,400 | |||||||||
Operating and Reportable segments | Segment | 2 | |||||||||
Silicon Valley Bank | ||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||
Cash and cash equivalents | $ 1,100 | $ 1,100 | ||||||||
Private Placement | ||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||
Common stock shares issued | shares | 23 | |||||||||
Public offering price per share | $ / shares | $ 0.95 | |||||||||
Proceeds from issuance of common stock net of underwriting discounts and commissions and other offering expenses | $ 59,000 | |||||||||
Prefunded Warrants | ||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||
Common stock shares issued | shares | 43.3 | 43.3 | ||||||||
Public offering price per share | $ / shares | $ 0.949 | |||||||||
Warrant exercise price per share | $ / shares | $ 0.001 |
Summary Accounting Policies a_4
Summary Accounting Policies and Recent Accounting Pronouncements - Additional Information (Details) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) Customer | Sep. 30, 2022 USD ($) Customer | |
Summary Of Accounting Policies [Line Items] | |||
Revenue, practical expedient, incremental cost of obtaining contract [true false] | true | ||
Revenue recognized | $ 800,000 | $ 800,000 | |
Impairment charge to definite-lived intangible, developed technology | $ 1,000,000 | ||
Impairment of long-lived assets related to cost of sales | 1,341,000 | 1,341,000 | |
Impairment charge of property and equipment | 2,300,000 | ||
Lease right-of-use assets | 0 | ||
Cost of Sales | |||
Summary Of Accounting Policies [Line Items] | |||
Impairment of long-lived assets related to cost of sales | $ 1,300,000 | ||
TDO | |||
Summary Of Accounting Policies [Line Items] | |||
Goodwill impairment | $ 8,500,000 | ||
ASU 2021-08 | |||
Summary Of Accounting Policies [Line Items] | |||
Change in accounting principle, accounting standards update, adopted [true false] | true | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | Jan. 01, 2023 | |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true | true | |
Customer Concentration Risk | Sales | |||
Summary Of Accounting Policies [Line Items] | |||
Number of customer accounted for sales | Customer | 0 | 0 | |
GentleWave Systems | Maximum | |||
Summary Of Accounting Policies [Line Items] | |||
Standard product warranty period | 2 years | 2 years |
Summary Accounting Policies a_5
Summary Accounting Policies and Recent Accounting Pronouncements - Summary of Balances of Contract Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Summary Of Accounting Policies [Line Items] | ||
Total contract liabilities | $ 798 | $ 817 |
Less: long-term portion | 221 | |
Contract liabilities – current | 577 | 817 |
Extended Service Contracts | ||
Summary Of Accounting Policies [Line Items] | ||
Total contract liabilities | 629 | 336 |
Subscription Software Licenses | ||
Summary Of Accounting Policies [Line Items] | ||
Total contract liabilities | $ 169 | $ 481 |
Summary Accounting Policies a_6
Summary Accounting Policies and Recent Accounting Pronouncements - Schedule of Revenues Disaggregated by Segment and Timing of Goods and Services Transferred (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | $ 10,406 | $ 9,846 | $ 32,173 | $ 29,426 |
Product | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | 8,163 | 7,795 | 25,604 | 23,440 |
Product | Point in Time | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | 7,934 | 7,616 | 25,075 | 22,909 |
Product | Over Time | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | 229 | 179 | 529 | 531 |
Software | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | 2,243 | 2,051 | 6,569 | 5,986 |
Software | Point in Time | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | 507 | 469 | 1,573 | 1,233 |
Software | Over Time | ||||
Summary Of Accounting Policies [Line Items] | ||||
Total revenue | $ 1,736 | $ 1,582 | $ 4,996 | $ 4,753 |
Summary Accounting Policies a_7
Summary Accounting Policies and Recent Accounting Pronouncements - Schedule of Reconciliation of Change in Estimated Warranty (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accounting Policies [Abstract] | ||||
Balance at beginning of period | $ 1,579 | $ 1,730 | $ 1,930 | $ 1,620 |
Provision for warranties issued | 170 | 328 | 570 | 1,108 |
Warranty costs incurred | (384) | (350) | (1,135) | (1,020) |
Balance at end of period | 1,365 | 1,708 | 1,365 | 1,708 |
Current portion | 1,228 | 1,212 | 1,228 | 1,212 |
Non-current portion | 137 | 496 | 137 | 496 |
Total | $ 1,365 | $ 1,708 | $ 1,365 | $ 1,708 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 6,733 | $ 9,269 |
Work in process | 569 | 427 |
Finished goods | 4,140 | 5,766 |
Total inventory | $ 11,442 | $ 15,462 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Reserve for excess and obsolete inventory | $ 1,900 | $ 1,900 | $ 500 | ||
Reserve for excess and obsolete inventory related to reduced sales volumes of legacy gentlewave console | 1,700 | ||||
Charge related to phasing out legacy procedure instruments | 1,200 | ||||
Excess and obsolete inventory | 600 | ||||
Impairment charge | 1,000 | ||||
Amortization intangible assets | 200 | $ 200 | 498 | $ 498 | |
Developed Technology | |||||
Impairment charge | $ 1,000 | ||||
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Operating Expenses | ||||
Cost of Sales | |||||
Amortization intangible assets | 200 | 200 | |||
Selling, General and Administrative Expenses | |||||
Amortization intangible assets | $ 300 | $ 300 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Intangible Assets Net (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Finite Lived Intangible Assets [Line Items] | ||
Weighted Average Amortization Period | 6 years 8 months 12 days | 7 years 7 months 6 days |
Gross | $ 3,380 | $ 4,715 |
Accumulated Amortization | 2,632 | 2,423 |
Net | $ 748 | $ 2,292 |
Developed Technology | ||
Finite Lived Intangible Assets [Line Items] | ||
Weighted Average Amortization Period | 1 year 7 months 6 days | 4 years |
Gross | $ 1,110 | $ 2,445 |
Accumulated Amortization | 1,101 | 1,123 |
Net | $ 9 | $ 1,322 |
Customer Relationships | ||
Finite Lived Intangible Assets [Line Items] | ||
Weighted Average Amortization Period | 4 years | 2 years 9 months 18 days |
Gross | $ 1,910 | $ 1,910 |
Accumulated Amortization | 1,353 | 1,148 |
Net | $ 557 | $ 762 |
Tradenames | ||
Finite Lived Intangible Assets [Line Items] | ||
Weighted Average Amortization Period | 1 year 1 month 6 days | 9 months 18 days |
Gross | $ 360 | $ 360 |
Accumulated Amortization | 178 | 152 |
Net | $ 182 | $ 208 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Intangible Assets Net (Parenthetical) (Details) | Sep. 30, 2023 | Dec. 31, 2022 |
Developed Technology | Minimum | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated useful life | 5 years | 5 years |
Developed Technology | Maximum | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated useful life | 10 years | 10 years |
Customer Relationships | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated useful life | 7 years | 7 years |
Tradenames | ||
Finite Lived Intangible Assets [Line Items] | ||
Estimated useful life | 10 years | 10 years |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Estimated Future Annual Amortization Expense Related to Intangible Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
2023 (remaining three months) | $ 86 | |
2024 | 309 | |
2025 | 252 | |
2026 | 36 | |
2027 and thereafter | 65 | |
Net | $ 748 | $ 2,292 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Total assets at fair value | $ 43,849 | $ 73,784 |
U.S. Treasury Securities | ||
Assets: | ||
Total assets at fair value | 20,538 | 33,622 |
Commercial Paper and Corporate Bonds | ||
Assets: | ||
Total assets at fair value | 14,549 | 40,162 |
U.S. Government Agency Bonds | ||
Assets: | ||
Total assets at fair value | 8,762 | |
Fair Value Measurements Recurring Basis | ||
Assets: | ||
Total cash equivalents at fair value | 10,635 | 16,242 |
Total assets at fair value | 54,484 | 90,026 |
Fair Value Measurements Recurring Basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total cash equivalents at fair value | 10,635 | 12,253 |
Total assets at fair value | 31,173 | 45,875 |
Fair Value Measurements Recurring Basis | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total cash equivalents at fair value | 3,989 | |
Total assets at fair value | 23,311 | 44,151 |
Fair Value Measurements Recurring Basis | Short-Term Investments | ||
Assets: | ||
Total assets at fair value | 43,849 | 73,784 |
Fair Value Measurements Recurring Basis | Short-Term Investments | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total assets at fair value | 20,538 | 33,622 |
Fair Value Measurements Recurring Basis | Short-Term Investments | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total assets at fair value | 23,311 | 40,162 |
Fair Value Measurements Recurring Basis | Money Market Funds | ||
Assets: | ||
Total cash equivalents at fair value | 10,635 | 12,253 |
Fair Value Measurements Recurring Basis | Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total cash equivalents at fair value | 10,635 | 12,253 |
Fair Value Measurements Recurring Basis | Commercial Paper | ||
Assets: | ||
Total cash equivalents at fair value | 1,998 | |
Fair Value Measurements Recurring Basis | Commercial Paper | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total cash equivalents at fair value | 1,998 | |
Fair Value Measurements Recurring Basis | U.S. Treasury Securities | Short-Term Investments | ||
Assets: | ||
Total assets at fair value | 20,538 | 33,622 |
Fair Value Measurements Recurring Basis | U.S. Treasury Securities | Short-Term Investments | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total assets at fair value | 20,538 | 33,622 |
Fair Value Measurements Recurring Basis | Commercial Paper and Corporate Bonds | Short-Term Investments | ||
Assets: | ||
Total assets at fair value | 14,549 | 40,162 |
Fair Value Measurements Recurring Basis | Commercial Paper and Corporate Bonds | Short-Term Investments | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total assets at fair value | 14,549 | 40,162 |
Fair Value Measurements Recurring Basis | U.S. Government Agency Bonds | ||
Assets: | ||
Total cash equivalents at fair value | 1,991 | |
Fair Value Measurements Recurring Basis | U.S. Government Agency Bonds | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total cash equivalents at fair value | $ 1,991 | |
Fair Value Measurements Recurring Basis | U.S. Government Agency Bonds | Short-Term Investments | ||
Assets: | ||
Total assets at fair value | 8,762 | |
Fair Value Measurements Recurring Basis | U.S. Government Agency Bonds | Short-Term Investments | Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total assets at fair value | $ 8,762 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Summary of Short-Term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Available-for-sale securities: | ||
Fair Value | $ 43,849 | $ 73,784 |
Cost Basis | 43,855 | 73,845 |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Gains | 1 | |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Losses | (7) | (61) |
U.S. Treasury Securities | ||
Available-for-sale securities: | ||
Fair Value | 20,538 | 33,622 |
Cost Basis | 20,540 | 33,676 |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Gains | 1 | |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Losses | (3) | (54) |
Commercial Paper and Corporate Bonds | ||
Available-for-sale securities: | ||
Fair Value | 14,549 | 40,162 |
Cost Basis | 14,549 | 40,169 |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Losses | $ (7) | |
U.S. Government Agency Bonds | ||
Available-for-sale securities: | ||
Fair Value | 8,762 | |
Cost Basis | 8,766 | |
Amounts Recognized in Accumulated Other Comprehensive Loss, Unrealized Losses | $ (4) |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||||
Sep. 27, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Apr. 30, 2022 | |
Class Of Stock [Line Items] | |||||
Number of warrants issued | 27,397 | 304,106 | |||
Warrant exercise price per share | $ 10.95 | $ 12 | |||
Number of warrants outstanding | 27,397 | 304,106 | |||
Proceeds from the issuance of common stock, net of issuance costs | $ 20,623 | ||||
Minimum | |||||
Class Of Stock [Line Items] | |||||
Warrants expiration date | 2023-12 | ||||
Maximum | |||||
Class Of Stock [Line Items] | |||||
Warrants expiration date | 2031-08 | ||||
Term Loan | Perceptive Credit Holdings III, LP | |||||
Class Of Stock [Line Items] | |||||
Warrant exercise price per share | $ 12 | ||||
Term Loan | Perceptive Credit Holdings III, LP | Common Stock | |||||
Class Of Stock [Line Items] | |||||
Number of warrants issued | 304,105 | ||||
Private Placement | |||||
Class Of Stock [Line Items] | |||||
Common stock shares issued | 23,000,000 | ||||
Price per share | $ 0.95 | ||||
Proceeds from the issuance of common stock, net of issuance costs | $ 59,000 | ||||
Prefunded Warrants | |||||
Class Of Stock [Line Items] | |||||
Number of warrants issued | 1,800,000 | ||||
Warrant exercise price per share | $ 0.001 | ||||
Number of warrants outstanding | 41,500,000 | ||||
Common stock shares issued | 43,300,000 | 43,300,000 | |||
Price per share | $ 0.949 | ||||
Percentage of exercisability of warrants | 9.99% | ||||
Threshold percentage of warrants | 19.99% |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 1,784 | $ 1,723 | $ 5,785 | $ 5,071 |
Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 645 | 779 | 2,233 | 2,579 |
RSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 1,094 | 905 | 3,389 | 2,440 |
ESPP | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 45 | 39 | 163 | 52 |
Cost of Sales | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 55 | 123 | 294 | 364 |
Selling, General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 1,584 | 1,435 | 4,927 | 3,820 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 145 | $ 165 | $ 564 | $ 887 |
Stock Based Compensation - Sc_2
Stock Based Compensation - Schedule of Unamortized Compensation Cost and Weighted Average Service Period of Unvested Outstanding Awards (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unamortized Compensation Costs | $ 13,763,978 |
Options | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unamortized Compensation Costs | $ 3,422,242 |
Weighted Average Service Period | 1 year 8 months 15 days |
RSUs | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unamortized Compensation Costs | $ 10,341,736 |
Weighted Average Service Period | 2 years 9 months 18 days |
Stock Based Compensation - Summ
Stock Based Compensation - Summary of Stock Option Activity under Incentive Plans (Details) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number of Shares, Options Outstanding, Beginning Balance | shares | 2,756,368 |
Number of Shares, Granted | shares | 195,120 |
Number of Shares, Forfeited | shares | (320,299) |
Number of Shares, Expired | shares | (99,156) |
Number of Shares, Options Outstanding, Ending Balance | shares | 2,532,033 |
Number of Shares, Options vested and exercisable at September 30, 2023 | shares | 1,839,527 |
Number of Shares, Vested and expected to vest after September 30, 2023 | shares | 2,474,615 |
Weighted Average Exercise Price Per Share, Options Outstanding, Beginning Balance | $ 2.83 |
Weighted Average Exercise Price Per Share, Granted | 1.08 |
Weighted Average Exercise Price Per Share, Forfeited | 2.35 |
Weighted Average Exercise Price Per Share, Expired | 1.14 |
Weighted Average Exercise Price Per Share, Ending Balance | 2.83 |
Weighted Average Exercise Price Per Share, Options vested and exercisable, September 30, 2023 | 2.7 |
Weighted Average Exercise Price Per Share, Vested and expected to vest after September 30, 2023 | $ 2.8 |
Weighted-Average Remaining Contractual Life (Years) Outstanding at September 30, 2023 | 6 years 7 months 6 days |
Weighted-Average Remaining Contractual Life (in years) Options vested and exercisable, September 30, 2023 | 6 years |
Weighted- Average Remaining Contractual Life (Years) Vested and exercisable at September 30, 2023 | 6 years 7 months 6 days |
Aggregate Intrinsic Value, Options outstanding, December 31, 2022 | $ | $ 1,510 |
Aggregate Intrinsic Value, Options Expired | $ 9 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Weighted-average grant-date fair value of options granted | $ 0.83 | $ 1.16 |
Fair value of shares vested | $ 2.1 | $ 2.6 |
Stock Based Compensation - Su_2
Stock Based Compensation - Summary of Non Vested Options (Details) - Options | Sep. 30, 2023 $ / shares shares |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, Non-vested Options, December 31, 2022 | shares | 1,118,088 |
Number of Shares, Non-vested Options, September 30, 2023 | shares | 692,506 |
Weighted Average Grant Date Fair Value, Non-vested Options, December 31, 2022 | $ / shares | $ 6.23 |
Weighted Average Grant Date Fair Value, Non-vested Options, September 30, 2023 | $ / shares | $ 6.33 |
Stock Based Compensation - Su_3
Stock Based Compensation - Summary of RSU Activity under Incentive Plans (Details) - RSUs | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares, RSUs outstanding, Beginning Balance | shares | 2,858,649 |
Number of Shares, Granted | shares | 3,541,198 |
Number of Shares, Vested | shares | (1,164,429) |
Number of Shares, Forfeited | shares | (608,359) |
Number of Shares, RSUs outstanding, Ending Balance | shares | 4,627,059 |
Weighted Average Grant Date Fair Value, RSUs outstanding, Beginning Balance | $ / shares | $ 4.49 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 1.57 |
Weighted Average Exercise Date Fair Value, Exercised | $ / shares | 3.36 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 3.45 |
Weighted Average Grant Date Fair Value, RSUs outstanding, Ending Balance | $ / shares | $ 2.68 |
Leases - Additional Information
Leases - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Operating lease description | The Company leases office space under operating leases with expirations ranging from March 2025 to December 2026, some of which include rent escalations or an option to extend the lease for up to three years per renewal. The exercise of lease renewal options is at the sole discretion of the Company. |
Operating lease renewal term | 3 years |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true |
Operating lease, not yet commenced, description | the Company has not entered into any leases that have not yet commenced that would entitle the Company to significant rights or create additional obligations. |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 (remaining six months) | $ 251 | |
2024 | 1,555 | |
2025 | 1,010 | |
2026 | 645 | |
Total future minimum lease payments | 3,461 | |
Less: Imputed Interest | (345) | |
Present value of operating lease liabilities | 3,116 | |
Less: Current portion | 1,334 | $ 1,114 |
Long-term operating lease liabilities | $ 1,782 | $ 1,095 |
Weighted average remaining lease term in years | 2 years 6 months 14 days | |
Weighted average discount rate | 8.81% |
Leases - Components of Lease Ex
Leases - Components of Lease Expense and Related Cash Flows (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Lessee, Lease, Description [Line Items] | ||||
Rent expense | $ 373 | $ 319 | $ 1,140 | $ 956 |
Variable lease costs | 17 | 26 | 81 | 79 |
Lease costs | 390 | 345 | 1,221 | 1,035 |
Cash paid for operating leases | 382 | 321 | 1,140 | 951 |
Cost of Sales | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease costs | 67 | 58 | 205 | 174 |
Selling, General and Administrative | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease costs | $ 323 | $ 287 | $ 1,016 | $ 861 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Apr. 06, 2022 | Aug. 31, 2022 | Jul. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2026 | Dec. 31, 2024 | Sep. 30, 2024 | Sep. 30, 2021 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||||||||
Number of warrants issued | 27,397 | 304,106 | ||||||||
Purchase price per share of warrant | $ 10.95 | $ 12 | ||||||||
Net proceeds from debt | $ 9,850 | |||||||||
Amended Perceptive Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Aggregate minimum cash balance | $ 3,000 | |||||||||
Debt instrument covenant description | The Perceptive Loan Agreement, as amended, contains events of default, including, without limitation, upon: (i) failure to make a payment pursuant to the terms of the agreement; (ii) violation of certain covenants; (iii) payment or other defaults on other indebtedness; (iv) material adverse change in the business or change in control; (v) insolvency; (vi) significant judgments; (vii) incorrectness of representations and warranties; (viii) regulatory matters; and (ix) failure by us to maintain a valid and perfected lien on the collateral securing the borrowing. The Perceptive Loan Agreement, as amended, includes financial covenants that require the Company to (i) maintain, at all times, a minimum aggregate balance of $3.0 million in cash in one or more controlled accounts, and (ii) satisfy certain minimum revenue thresholds, measured for the consecutive 12-month periods ending on each calendar quarter-end until June 30, 2026. These thresholds progressively increase over time, ranging from $26.4 million for the consecutive 12-month periods ending September 30, 2021 to $95.3 million for the consecutive 12-month periods ending June 30, 2026. Specifically, the minimum revenue thresholds for the consecutive 12-months period ending on September 30, 2024 and December 31, 2024, are $52.0 million and $58.6 million, respectively. Failure to satisfy these covenants would constitute an event of default under the agreement, as amended. In the event of an event of default, the lender may terminate its commitments and declare all amounts outstanding under the Perceptive Loan Agreement, as amended, immediately due and payable, together with accrued interest and all fees and other obligations. The amount of such repayment will include payment of any prepayment premium applicable due to the time of such payment. In addition, upon the occurrence and during the continuance of any event of default, the applicable margin will increase by 3.00% per annum to 12.25%. As of September 30, 2023, we were in compliance with all covenants and conditions required by the outstanding Perceptive Loan Agreement, as amended. | |||||||||
Amended Perceptive Loan Agreement | Forecast | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Minimum revenue thresolds amount | $ 58,600 | $ 52,000 | ||||||||
First Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of warrants issued | 304,105 | |||||||||
Purchase price per share of warrant | $ 12 | |||||||||
Portion of warrants transferred to third party | 153,421 | |||||||||
Minimum | Amended Perceptive Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Effective interest rate percentage | 3% | |||||||||
Revenue thresholds increase over time | $ 26,400 | |||||||||
Maximum | Amended Perceptive Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Effective interest rate percentage | 12.25% | |||||||||
Maximum | Amended Perceptive Loan Agreement | Forecast | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Revenue thresholds increase over time | $ 95,300 | |||||||||
LIBOR Plus 2% | Minimum | Amended Perceptive Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Effective interest rate percentage | 9.25% | 9.25% | ||||||||
Additional interest rate on borrowing | 2% | 2% | ||||||||
Tranche One | Amended Perceptive Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowed amount | $ 10,000 | |||||||||
Net proceeds from debt | $ 9,900 | |||||||||
Tranche One | First Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Delayed draw term loan | $ 10,000 | |||||||||
Delayed-draw term loans start date | Dec. 31, 2021 | |||||||||
Delayed-draw term loans end date | Sep. 30, 2022 | |||||||||
Tranche Two | First Amendment | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Delayed draw term loan | $ 10,000 | |||||||||
Delayed-draw term loans start date | Mar. 31, 2022 | |||||||||
Delayed-draw term loans end date | Jun. 30, 2023 | |||||||||
Perceptive Credit Holdings III, LP | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Effective interest rate percentage | 17.39% | 14.31% |
Term Loan - Schedule of Future
Term Loan - Schedule of Future Principal Repayments of Term Loan (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2026 | $ 40,000 |
Total | $ 40,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Internal Revenue Code | R&D credit carryforwards | |
Income Tax Contingency [Line Items] | |
Ownership change percentage | 50% |
Federal | |
Income Tax Contingency [Line Items] | |
Open tax year | 2020 2021 2022 |
State | |
Income Tax Contingency [Line Items] | |
Open tax year | 2019 2020 2021 2022 |
Segment Information - Additiona
Segment Information - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Segment Reporting Information [Line Items] | ||
Impairment of long-lived assets | $ 3,392 | |
Impairment of long-lived assets related to cost of sales | $ 1,341 | 1,341 |
Product | ||
Segment Reporting Information [Line Items] | ||
Impairment of long-lived assets | 3,400 | |
Impairment of long-lived assets related to cost of sales | $ 1,341 | 1,341 |
Inventory related cost of sales | $ 2,900 |
Segment Information - Summary o
Segment Information - Summary of Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Segment Reporting Information [Line Items] | ||||
Revenue | $ 10,406 | $ 9,846 | $ 32,173 | $ 29,426 |
Cost of sales, product and software | 6,619 | 7,528 | 23,942 | 22,276 |
Impairment of long-lived assets | 1,341 | 1,341 | ||
Total cost of sales | 7,960 | 7,528 | 25,283 | 22,276 |
Gross profit | $ 2,446 | $ 2,318 | $ 6,890 | $ 7,150 |
Gross margin | 24% | 24% | 21% | 24% |
Operating expenses: | ||||
Selling, general and administrative | $ 13,442 | $ 12,586 | $ 42,859 | $ 37,393 |
Research and development | 3,049 | 4,328 | 9,841 | 13,196 |
Impairment of long-lived assets | 2,051 | 2,051 | ||
Total operating expenses | 18,542 | 16,914 | 54,751 | 50,589 |
Loss from operations | (16,096) | (14,596) | (47,861) | (43,439) |
Product | ||||
Segment Reporting Information [Line Items] | ||||
Revenue | 8,163 | 7,795 | 25,604 | 23,440 |
Cost of sales, product and software | 5,938 | 6,875 | 21,886 | 20,338 |
Impairment of long-lived assets | 1,341 | 1,341 | ||
Total cost of sales | 7,279 | 6,875 | 23,227 | 20,338 |
Gross profit | $ 884 | $ 920 | $ 2,377 | $ 3,102 |
Gross margin | 11% | 12% | 9% | 13% |
Operating expenses: | ||||
Selling, general and administrative | $ 12,847 | $ 12,141 | $ 41,070 | $ 35,911 |
Research and development | 2,551 | 3,891 | 8,242 | 11,874 |
Impairment of long-lived assets | 2,051 | 2,051 | ||
Total operating expenses | 17,449 | 16,032 | 51,363 | 47,785 |
Loss from operations | (16,565) | (15,112) | (48,986) | (44,683) |
Software | ||||
Segment Reporting Information [Line Items] | ||||
Revenue | 2,243 | 2,051 | 6,569 | 5,986 |
Cost of sales, product and software | 681 | 653 | 2,056 | 1,938 |
Total cost of sales | 681 | 653 | 2,056 | 1,938 |
Gross profit | $ 1,562 | $ 1,398 | $ 4,513 | $ 4,048 |
Gross margin | 70% | 68% | 69% | 68% |
Operating expenses: | ||||
Selling, general and administrative | $ 595 | $ 445 | $ 1,789 | $ 1,482 |
Research and development | 498 | 437 | 1,599 | 1,322 |
Total operating expenses | 1,093 | 882 | 3,388 | 2,804 |
Loss from operations | $ 469 | $ 516 | $ 1,125 | $ 1,244 |
Segment Information - Segment A
Segment Information - Segment Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Segment Reporting Asset Reconciling Item [Line Items] | ||
Total assets | $ 88,327 | $ 137,285 |
Product | ||
Segment Reporting Asset Reconciling Item [Line Items] | ||
Total assets | 77,446 | 125,713 |
Software | ||
Segment Reporting Asset Reconciling Item [Line Items] | ||
Total assets | $ 10,881 | $ 11,572 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||||||
Net loss | $ (16,980) | $ (17,690) | $ (15,371) | $ (15,539) | $ (15,137) | $ (15,522) | $ (50,041) | $ (46,198) |
Denominator: | ||||||||
Weighted-average shares outstanding - basic | 94,286,107 | 33,116,536 | 93,790,557 | 28,688,018 | ||||
Weighted-average shares outstanding - diluted | 94,286,107 | 33,116,536 | 93,790,557 | 28,688,018 | ||||
Net loss per share - basic | $ (0.18) | $ (0.47) | $ (0.53) | $ (1.61) | ||||
Net loss per share - diluted | $ (0.18) | $ (0.47) | $ (0.53) | $ (1.61) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Details) - shares shares in Millions | 9 Months Ended | |
Sep. 27, 2022 | Sep. 30, 2023 | |
Prefunded Warrants | ||
Class of Stock [Line Items] | ||
Common stock shares issued | 43.3 | 43.3 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Potentially Dilutive Securities Excluded from the Computation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 7,490,595 | 6,252,469 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 2,532,033 | 2,985,032 |
RSUs | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 4,627,059 | 2,935,934 |
Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 331,503 | 331,503 |