Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 27, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38721 | ||
Entity Registrant Name | Axonics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-4744083 | ||
Entity Address, Address Line One | 26 Technology Drive | ||
Entity Address, City or Town | Irvine, | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92618 | ||
City Area Code | (949) | ||
Local Phone Number | 396-6322 | ||
Title of 12(b) Security | Common stock, par value $0.0001 per share | ||
Trading Symbol | AXNX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 2,646.8 | ||
Entity Common Stock, Shares Outstanding | 49,963,601 | ||
Documents Incorporated by Reference | The information that is required to be included in Part III of this Annual Report on Form 10-K is incorporated by reference to either a definitive proxy statement or an amendment to this Annual Report on Form 10-K to be filed by the registrant within 120 days of December 31, 2022. Only those portions of any such definitive proxy statement that are specifically incorporated by reference herein shall constitute a part of this Annual Report on Form 10-K . | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001603756 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | BDO USA, LLP |
Auditor Location | Costa Mesa, California |
Auditor Firm ID | 243 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 238,846 | $ 220,878 |
Short-term investments | 118,365 | 0 |
Accounts receivable, net of allowance for credit losses of $321 and $355 at December 31, 2022 and 2021, respectively | 44,817 | 29,044 |
Inventory, net | 55,765 | 64,946 |
Prepaid expenses and other current assets | 7,282 | 6,449 |
Total current assets | 465,075 | 321,317 |
Property and equipment, net | 6,798 | 6,915 |
Intangible assets, net | 86,253 | 106,469 |
Other assets | 6,813 | 7,734 |
Goodwill | 94,414 | 105,510 |
Total assets | 659,353 | 547,945 |
Current liabilities | ||
Accounts payable | 9,070 | 7,654 |
Accrued liabilities | 6,520 | 5,435 |
Accrued compensation and benefits | 15,495 | 12,413 |
Operating lease liability, current portion | 1,562 | 1,366 |
Other current liabilities | 32,600 | 0 |
Total current liabilities | 65,247 | 26,868 |
Operating lease liability, net of current portion | 7,555 | 9,052 |
Deferred tax liabilities, net | 16,412 | 19,217 |
Other long-term liabilities | 0 | 10,370 |
Total liabilities | 89,214 | 65,507 |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity | ||
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2022 and 2021 | 0 | 0 |
Common stock, par value $0.0001 per share, 75,000,000 and 50,000,000 shares authorized at December 31, 2022 and 2021, respectively; 49,546,727 and 46,330,167 shares issued and outstanding at December 31, 2022 and 2021, respectively | 5 | 5 |
Additional paid-in capital | 969,545 | 803,559 |
Accumulated deficit | (374,264) | (314,566) |
Accumulated other comprehensive loss | (25,147) | (6,560) |
Total stockholders’ equity | 570,139 | 482,438 |
Total liabilities and stockholders’ equity | $ 659,353 | $ 547,945 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for credit losses | $ 321 | $ 355 |
Preferred stock, par value (USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock issued (shares) | 0 | 0 |
Preferred stock outstanding (shares) | 0 | 0 |
Common stock, par value (USD per share) | $ 0.0001 | $ 0.0001 |
Common stock authorized (shares) | 75,000,000 | 50,000,000 |
Common stock issued (shares) | 49,546,727 | 46,330,167 |
Common stock outstanding (shares) | 49,546,727 | 46,330,167 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net revenue | $ 273,702 | $ 180,290 | $ 111,535 |
Cost of goods sold | 76,037 | 64,572 | 44,444 |
Gross profit | 197,665 | 115,718 | 67,091 |
Operating expenses | |||
Research and development | 34,410 | 37,297 | 29,055 |
General and administrative | 40,238 | 30,041 | 25,551 |
Sales and marketing | 156,019 | 105,789 | 66,130 |
Amortization of intangible assets | 9,383 | 7,241 | 115 |
Acquisition-related costs | 22,561 | 7,158 | 0 |
Total operating expenses | 262,611 | 187,526 | 120,851 |
Loss from operations | (64,946) | (71,808) | (53,760) |
Other income (expense) | |||
Interest and other income | 5,133 | 40 | 761 |
Loss on disposal of property and equipment | (69) | (91) | (41) |
Interest and other expense | (2,434) | (7,426) | (1,874) |
Other income (expense), net | 2,630 | (7,477) | (1,154) |
Loss before income tax (benefit) expense | (62,316) | (79,285) | (54,914) |
Income tax (benefit) expense | (2,618) | 782 | 1 |
Net loss | (59,698) | (80,067) | (54,915) |
Foreign currency translation adjustment | (18,587) | (6,129) | (3) |
Comprehensive loss | $ (78,285) | $ (86,196) | $ (54,918) |
Net loss per share, basic (USD per share) | $ (1.28) | $ (1.86) | $ (1.48) |
Net loss per share, diluted (USD per share) | $ (1.28) | $ (1.86) | $ (1.48) |
Weighted-average shares used to compute basic net loss per share (shares) | 46,684,478 | 43,072,298 | 36,981,335 |
Weighted-average shares used to compute diluted net loss per share (shares) | 46,684,478 | 43,072,298 | 36,981,335 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Balance at beginning of period (shares) at Dec. 31, 2019 | 34,110,995 | ||||
Balance at beginning of period at Dec. 31, 2019 | $ 183,003 | $ 3 | $ 363,012 | $ (179,584) | $ (428) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock for employee stock option exercises for cash (shares) | 767,792 | ||||
Issuance of common stock for employee stock option exercises for cash | 3,703 | 3,703 | |||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (shares) | 405,907 | ||||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation | 11,792 | 11,792 | |||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation (shares) | 46,336 | ||||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation | 3,303 | 3,303 | |||
Follow-on offering - issuance of shares, less offering costs (shares) | 4,600,000 | ||||
Follow-on offering - issuance of shares, less closing costs | 140,487 | $ 1 | 140,486 | ||
Issuance of common stock for acquisition of Contura Limited | 0 | ||||
Foreign currency translation adjustment | (3) | (3) | |||
Net loss | (54,915) | (54,915) | |||
Balance at end of period (shares) at Dec. 31, 2020 | 39,931,030 | ||||
Balance at end of period at Dec. 31, 2020 | 287,370 | $ 4 | 522,296 | (234,499) | (431) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock for employee stock option exercises for cash (shares) | 522,495 | ||||
Issuance of common stock for employee stock option exercises for cash | 6,757 | 6,757 | |||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (shares) | 520,411 | ||||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation | 17,793 | 17,793 | |||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation (shares) | 169,054 | ||||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation | 7,371 | 7,371 | |||
Follow-on offering - issuance of shares, less offering costs (shares) | 4,025,000 | ||||
Follow-on offering - issuance of shares, less closing costs | 189,978 | $ 1 | 189,977 | ||
Issuance of common stock for acquisition of Contura Limited (shares) | 1,096,583 | ||||
Issuance of common stock for acquisition of Contura Limited | 55,728 | 55,728 | |||
Issuance of common stock for exclusive license asset (shares) | 65,594 | ||||
Issuance of common stock for exclusive license asset | 3,637 | 3,637 | |||
Foreign currency translation adjustment | (6,129) | (6,129) | |||
Net loss | $ (80,067) | (80,067) | |||
Balance at end of period (shares) at Dec. 31, 2021 | 46,330,167 | 46,330,167 | |||
Balance at end of period at Dec. 31, 2021 | $ 482,438 | $ 5 | 803,559 | (314,566) | (6,560) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock for employee stock option exercises for cash (shares) | 364,352 | ||||
Issuance of common stock for employee stock option exercises for cash | 5,662 | 5,662 | |||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (shares) | 570,778 | ||||
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation | 26,218 | 26,218 | |||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation (shares) | 268,930 | ||||
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation | 5,800 | 5,800 | |||
Follow-on offering - issuance of shares, less offering costs (shares) | 2,012,500 | ||||
Follow-on offering - issuance of shares, less closing costs | 128,306 | 128,306 | |||
Issuance of common stock for acquisition of Contura Limited | 0 | ||||
Foreign currency translation adjustment | (18,587) | (18,587) | |||
Net loss | $ (59,698) | (59,698) | |||
Balance at end of period (shares) at Dec. 31, 2022 | 49,546,727 | 49,546,727 | |||
Balance at end of period at Dec. 31, 2022 | $ 570,139 | $ 5 | $ 969,545 | $ (374,264) | $ (25,147) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock issuance - offering costs | $ 192 | $ 11,272 | $ 9,013 |
Common Stock | |||
Follow-on offering - issuance of shares, less offering costs (shares) | 2,012,500 | 4,025,000 | 4,600,000 |
Stock issuance price (USD per share) | $ 63.85 | $ 50 | $ 32.50 |
Stock issuance - offering costs | $ 192 | $ 11,272 | $ 9,013 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash Flows from Operating Activities | |||
Net loss | $ (59,698) | $ (80,067) | $ (54,915) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities | |||
Depreciation and amortization | 11,721 | 9,126 | 1,741 |
Loss on disposal of property and equipment | 69 | 91 | 41 |
Stock-based compensation | 32,018 | 25,164 | 15,095 |
Amortization of debt issuance costs | 0 | 4,991 | 774 |
(Reversal of) provision for allowance of credit losses | (34) | (122) | 390 |
Change in fair value of contingent consideration | 22,230 | 2,740 | 0 |
Deferred income taxes and other items, net | (184) | 582 | 165 |
Changes in operating assets and liabilities, net of business acquisition | |||
Accounts receivable | (15,968) | (8,998) | (10,781) |
Inventory | 8,423 | (1,108) | (47,353) |
Prepaid expenses and other current assets | (862) | (940) | (863) |
Other assets | (207) | (225) | (90) |
Accounts payable | 1,468 | (2,862) | 4,778 |
Accrued liabilities | 1,032 | (1,976) | 4,193 |
Accrued compensation and benefits | 3,112 | 6,155 | 2,573 |
Lease liability | 71 | 143 | 510 |
Net cash provided by (used in) operating activities | 3,191 | (47,306) | (83,742) |
Cash Flows from Investing Activities | |||
Purchases of property and equipment | (2,223) | (2,261) | (2,938) |
Acquisition of a business, net of cash acquired | 0 | (140,741) | 0 |
Purchases of short-term investments | (175,110) | 0 | 0 |
Proceeds from sales and maturities of short-term investments | 56,979 | 0 | 12,592 |
Net cash (used in) provided by investing activities | (120,354) | (143,002) | 9,654 |
Cash Flows from Financing Activities | |||
Payment of debt issuance costs | 0 | (106) | 0 |
Proceeds from debt | 0 | 75,000 | 0 |
Repayment of debt | 0 | (101,116) | 0 |
Proceeds from offering of common stock upon follow-on public offering | 128,498 | 201,250 | 149,500 |
Payment of common stock offering costs upon follow-on public offering | (192) | (11,272) | (9,013) |
Proceeds from exercise of stock options | 5,662 | 6,757 | 3,703 |
Net cash provided by financing activities | 133,968 | 170,513 | 144,190 |
Effect of exchange rate changes on cash and cash equivalents | 1,163 | (508) | (3) |
Net increase (decrease) in cash and cash equivalents | 17,968 | (20,303) | 70,099 |
Cash and cash equivalents, beginning of year | 220,878 | 241,181 | 171,082 |
Cash and cash equivalents, end of year | 238,846 | 220,878 | 241,181 |
Supplemental Disclosure of Cash Flow Information | |||
Cash paid for interest | 1 | 2,178 | 1,102 |
Cash paid for taxes | 667 | 1 | 1 |
Noncash Investing and Financing Activities | |||
Property and equipment acquired but not yet paid | 67 | 0 | 0 |
Common stock issuance for business acquisition | 0 | 55,728 | 0 |
Contingent consideration for business acquisition | 0 | 7,630 | 0 |
Common stock issuance for exclusive license asset | 0 | 3,637 | 0 |
Accrued loan fees as debt issuance costs | $ 0 | $ 4,500 | $ 0 |
Nature of Operations and Summar
Nature of Operations and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations and Summary of Significant Accounting Policies | Nature of Operations and Summary of Significant Accounting Policies Nature of Operations Axonics, Inc. (the Company) was incorporated in the state of Delaware on March 2, 2012 under the name American Restorative Medicine, Inc. The Company had no operations until October 1, 2013, when the license agreement between Alfred E. Mann Foundation for Scientific Research (AMF) and the Company (the License Agreement) was entered into. In August 2013, the Company changed its name to Axonics Modulation Technologies, Inc. In March 2021, the Company changed its name to Axonics, Inc. The Company is a medical technology company that develops and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction. The Company has designed and developed both rechargeable (R20™) and recharge-free (F15™) implantable sacral neuromodulation (SNM) systems, which deliver mild electrical pulses to the targeted sacral nerve in order to restore normal communication to and from the brain to reduce the symptoms of overactive bladder (OAB), urinary retention (UR) and fecal incontinence (FI). The Company’s products are protected by intellectual property based on Company-generated innovations and patents and other intellectual property licensed from AMF. The Company has marketing approvals in the United States, Europe, Canada, and Australia for all relevant clinical indications. The premarket approval (PMA) application for the rechargeable SNM system for the treatment of FI was approved by the U.S. Food and Drug Administration (FDA) on September 6, 2019, and the PMA application for the rechargeable SNM system for the treatment of OAB and UR was approved by the FDA on November 13, 2019. Accordingly, the Company began U.S. commercialization of its rechargeable SNM system in the fourth quarter of 2019. Prior to the fourth quarter of 2019, the Company derived revenue only from its international operations in select markets including England, the Netherlands and Canada, and its activities had consisted primarily of developing the rechargeable SNM system, conducting its RELAX-OAB post-market clinical follow-up study in Europe, its ARTISAN-SNM pivotal clinical study in the United States and hiring and training its U.S. commercial team in preparation for the launch of the rechargeable SNM system in the United States. Beginning in February 2021 with the acquisition of Contura Limited, the Company also markets Bulkamid®, a urethral bulking agent to treat female stress urinary incontinence (SUI). Beginning in March 2022 with the FDA approval of the Company’s long-lived, recharge-free F15 SNM implantable stimulator, the Company now markets and sells the F15 recharge-free system to customers in the United States in addition to the rechargeable SNM system. The new recharge-free SNM system and Bulkamid are protected by intellectual property based on Company-generated innovations or patents acquired as part of the Contura acquisition. For more information, see Note 9. May 2020 Follow-On Offering On May 12, 2020, the Company completed a follow-on offering by issuing 4,600,000 shares of common stock, at an offering price of $32.50 per share, inclusive of 600,000 shares of the Company’s common stock issued upon the exercise by the underwriters of their option to purchase additional shares. The net proceeds to the Company were approximately $140.5 million, after deducting underwriting discounts, commissions and offering expenses payable by the Company. May 2021 Follow-On Offering On May 14, 2021, the Company completed a follow-on offering by issuing 4,025,000 shares of common stock, at an offering price of $50.00 per share, inclusive of 525,000 shares of the Company’s common stock issued upon the exercise by the underwriters of their option to purchase additional shares. The net proceeds to the Company were approximately $190.0 million, after deducting underwriting discounts, commissions and offering expenses payable by the Company. August 2022 Follow-On Offering On August 5, 2022, the Company completed a follow-on offering by issuing 2,012,500 shares of common stock, at an offering price of $63.85 per share, inclusive of 262,500 shares of the Company’s common stock issued upon the exercise by the underwriters of their option to purchase additional shares. The net proceeds to the Company were approximately $128.3 million, after deducting offering expenses payable by the Company. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company; its wholly-owned subsidiaries: Axonics Europe, S.A.S., Axonics Modulation Technologies U.K. Limited, Axonics Modulation Technologies Australia Pty Ltd, Axonics Women’s Health Limited, Bulkamid SARL, Axonics GmbH, and Contura, Inc. Intercompany accounts and transactions have been eliminated in consolidation. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). Certain prior year reported amounts have been reclassified to conform with the 2022 presentation. COVID-19 The ongoing COVID-19 outbreak, and the resulting restrictions intended to slow the spread of COVID-19, including stay-at-home orders, business shutdowns and other restrictions, has adversely affected the Company’s business in several ways. The primary impact on the Company’s business was the cancellation or delay of elective procedures in certain areas to allow health care facilities to prioritize the treatment of COVID-19 patients during the initial stages and resurgence periods of the pandemic or because patients are avoiding health care facilities that they feel are unsafe. These developments materially reduced the number of procedures using the Company’s rechargeable SNM system. If governmental authorities recommend again in the future that it is deemed advisable for health care facilities to not perform outpatient elective procedures, as was the case at various times throughout 2020 through 2022, the Company expects it would materially harm the Company’s revenues and potentially increase the Company’s operating loss. Even as efforts to contain the pandemic have made progress and some restrictions have relaxed, new variants of the virus may continue to cause additional outbreaks. These challenges will likely continue for the duration of the pandemic and could reduce the Company’s revenue and negatively impact the Company’s business, financial condition and results of operations while the pandemic continues. If these delays in procedures occur in the future, the Company may have to scale back its business, including reducing headcount, which could have a negative impact on the Company’s long-term operations. The Company could also experience other negative impacts of the COVID-19 outbreak such as the lack of availability of the Company’s key personnel, temporary closures of the Company’s office or the facilities of the Company’s business partners, customers, third party service providers or other vendors, and the interruption of the Company’s supply chain, distribution channels, liquidity and capital or financial markets. Any disruption and volatility in the global capital markets as a result of the pandemic may increase the Company’s cost of capital and adversely affect the Company’s ability to access financing when and on terms that the Company desires. In addition, a recession resulting from the spread of COVID-19 could materially affect the Company’s business, especially if a recession results in higher unemployment causing potential patients to not have access to health insurance. The ultimate extent to which the COVID-19 pandemic and its repercussions impact the Company’s business will depend on future developments, which are highly uncertain. However, the foregoing and other continued disruptions to the Company’s business as a result of COVID-19 could result in a material adverse effect on the Company’s business, results of operations, financial condition and cash flows. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses, and related disclosure of contingent assets and liabilities. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. The results of this evaluation then form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates and such differences may be material to the consolidated financial statements. Significant items subject to such estimates and assumptions include the useful lives of property and equipment and intangible assets, the valuation of deferred income tax assets and liabilities, the valuation of contingent consideration liability, the valuation of stock-based compensation, the product returns reserve, the inventory obsolescence reserve and accounts receivable allowance for credit losses. Revenue Recognition Revenue recognized during the years ended December 31, 2022, 2021, and 2020 relates entirely to the sale of the Company’s products to its customers and distributors. The Company has revenue arrangements that consist of a single performance obligation. The Company recognizes revenue at the point in time when it transfers control of promised goods to its customers. Revenue is measured as the amount of consideration it expected to be received in exchange for transferring goods. The amount of revenue that is recognized is based on the transaction price, which represents the invoiced amount and includes estimates of variable consideration such as discounts, where applicable. The Company also sells to distributors and applies the same policies as its revenue arrangements with customers, specifically that revenue is recognized at the point in time when it transfers control of promised goods to its distributors. The Company does not offer rights of return or price protection. The amount of variable consideration included in the transaction price may be constrained and is included only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Payment terms, typically less than three months, do not include a significant financing component. The Company extends credit to its customers and distributors based upon an evaluation of their financial condition and credit history and generally requires no collateral. The Company does not have any contract balances related to product sales. The Company also does not have significant contract acquisition costs related to product sales. In accordance with Company policy and based on the Company’s historical experience, the allowance for product returns was $0.2 million and $0.2 million at December 31, 2022 and 2021, respectively, and is recorded as a reduction of gross revenue in its consolidated statements of comprehensive loss. Damaged or defective products are replaced at no charge under the Company’s standard warranty. For the years ended December 31, 2022, 2021, and 2020, the replacement costs were $0.2 million, $0.2 million, and $0.1 million, respectively. The replacement costs are recorded within the sales and marketing expenses in its consolidated statements of comprehensive loss. The Company offers its standard warranty to all customers. The Company does not sell any warranties on a standalone basis. The Company’s warranty provides that its products are free of material defects and conform to specifications, and includes an offer to repair, replace or refund the purchase price of defective products. This assurance does not constitute a service and is not considered a separate performance obligation. The Company estimates warranty liabilities at the time of revenue recognition and records it as a charge to sales and marketing expense. The warranty liability as of December 31, 2022 and 2021 was $0.1 million and $0.1 million, respectively. Shipping and handling costs incurred for the delivery of goods to customers and distributors are included in cost of goods sold. Amounts billed to customers and distributors for shipping and handling are included in net revenue. The following table provides additional information pertaining to net revenue disaggregated by product and geographic market for the years ended December 31, 2022, 2021, and 2020 (in thousands): Years Ended December 31, 2022 2021 2020 SNM net revenue United States $ 216,861 $ 153,837 $ 107,542 International markets 5,130 3,753 3,993 $ 221,991 $ 157,590 $ 111,535 Bulkamid net revenue (1) United States $ 40,178 $ 12,660 $ — International markets 11,533 10,040 — $ 51,711 $ 22,700 $ — Total net revenue $ 273,702 $ 180,290 $ 111,535 _____________________________________________ (1) The acquisition of Bulkamid was completed on February 25, 2021. Reported revenue includes sales from February 26, 2021 onwards. Allowance for Credit Losses The Company makes estimates of the collectability of accounts receivable in accordance with ASU 2016-13, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The Company’s estimate of future credit losses is made by management based upon historical bad debts, customer receivable balances, age of customer receivable balances, customers’ financial conditions and reasonable forecasted economic trends. Despite the Company’s efforts to minimize credit risk exposure, customers could be adversely affected if future economic and industry trends, including those related to COVID-19, change in such a manner as to negatively impact their cash flows. The full effects of COVID-19 on the Company’s customers are highly uncertain and cannot be predicted. As a result, the Company’s future collection experience can differ significantly from historical collection trends. If the Company’s customers experience a negative impact on their cash flows, it could have a material adverse effect on the Company’s results of operations and financial condition. The following table summarizes the changes in our allowance for credit losses (in thousands): Years Ended December 31, 2022 2021 2020 Balance at beginning of period $ 355 $ 465 $ 75 Write-offs (75) (12) — Bad debt expense (recoveries) 41 (98) 390 Balance at end of period $ 321 $ 355 $ 465 Cash and Cash Equivalents Cash equivalents consist of short-term, highly liquid investments purchased with an original maturity of three months or less. Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. At times, the cash and cash equivalent balances may exceed federally insured limits. The Company does not believe that this results in any significant credit risk as the Company’s policy is to place its cash and cash equivalents in highly-rated financial institutions. The Company also holds cash in foreign banks that are not federally insured. The Company has not experienced any losses on its deposits of cash and cash equivalents. Fair Value of Financial Instruments Fair value is defined 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 three-level fair value hierarchy prioritizes the inputs used to measure fair value. The hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1: Inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs are quoted prices for similar assets and liabilities in active markets or quoted prices for identical or similar instruments in markets that are not active and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. • Level 3: Inputs are unobservable inputs based on the Company’s assumptions and valuation techniques used to measure assets and liabilities at fair value. The inputs require significant management judgment or estimation. Level 1 investments include U.S. government and agency securities, which are valued based on prices readily available in the active markets in which those securities are traded. Level 2 investments include commercial paper and corporate notes, which is valued on a recurring basis based on inputs that are readily available in public markets or can be derived from information available in publicly quoted markets. The Company’s assessment of the significance of an input to the fair value measurement requires judgment, which may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels. The carrying amounts reported in the consolidated financial statements approximate the fair value for cash and cash equivalents, accounts receivable, and accounts payables, due to their short-term nature. The purchase price of business acquisitions is primarily allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the acquisition date, with the excess recorded as goodwill. Certain of the Company’s business combinations involve potential payment of future consideration that is contingent upon the achievement of certain product development milestones and/or contingent on the acquired business reaching certain performance milestones. A liability is recorded for the estimated fair value of the contingent consideration on the acquisition date. The fair value of the contingent consideration is remeasured at each reporting period, and the change in fair value is recognized within operating expenses in the consolidated statements of comprehensive loss. On February 25, 2021, the Company acquired Contura Limited and its Bulkamid product, a urethral bulking agent indicated for the treatment of female SUI. In consideration for the acquisition, the Company paid approximately $141.3 million in cash and issued 1,096,583 shares of our common stock. The Company may pay an additional $35 million in the event Bulkamid sales in any consecutive 12-month period exceed $50 million (the Milestone) before December 31, 2024, with payment due within 50 business days following the quarter in which the Milestone has been met. Contingent consideration represents contingent milestone, performance and revenue-sharing payment obligations related to acquisitions and is measured at fair value, based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration is estimated using a binary option-based approach with assumptions the Company believes would be made by a market participant. Significant inputs include projected revenues, discount rates, volatility factors and risk-free rates. The Company assesses these assumptions on an ongoing basis as additional data impacting the assumptions is obtained and any change in fair value of the contingent consideration is recorded within acquisition-related costs in the consolidated statements of comprehensive loss. Significant increases or decreases in any of those inputs in isolation would result in a significantly lower or higher fair value measurement. Generally, a change in the assumption used for the projected revenues would result in a directionally similar change to the overall estimate of the contingent consideration. At December 31, 2022, the discount rates ranged from 8.5% to 9.0%, volatility was estimated at 24.5%, and risk-free rates ranged from 4.3% to 4.8%. The fair value of contingent consideration of $32.6 million at December 31, 2022, is reflected in other current liabilities on the Company’s consolidated balance sheets, as the Milestone is expected to be met within the next 12 months. The fair value of contingent consideration of $10.4 million at December 31, 2021, is reflected in other long-term liabilities on the Company’s consolidated balance sheets. The following table summarizes the changes in the fair value of recurring Level 3 fair value measurements during the years ended December 31, 2022 and 2021 (in thousands): Liabilities Contingent consideration: December 31, 2020 $ — February 25, 2021 Acquisition 7,630 Change in fair value included in earnings 2,740 December 31, 2021 10,370 Change in fair value included in earnings 22,230 December 31, 2022 $ 32,600 There were no transfers between Levels 1, 2 or 3 for the periods presented. Investment Securities The Company classifies its investment securities as available-for-sale. Those investments in debt securities with maturities less than 12 months at the balance sheet date are considered short-term investments. Those investments in debt securities with maturities greater than 12 months at the balance sheet date are considered long-term investments. The Company’s investment securities classified as available-for-sale are recorded at fair value based on the fair value hierarchy (Level 1 and Level 2 inputs in the fair value hierarchy), and consists primarily of commercial paper, corporate notes and U.S. government and agency securities. Unrealized gains or losses, deemed temporary in nature, are reported as other comprehensive income (loss) within the consolidated statements of comprehensive loss. There were no unrealized gains or losses during the years ended December 31, 2022, 2021, and 2020. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to net income (loss) and the corresponding establishment of a credit loss allowance for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight-line interest method. Dividend, accretion and interest income are recognized when earned. Realized gains or losses are included in net loss and are derived using the specific identification method for determining the cost of securities sold. The Company had no outstanding investment securities as of December 31, 2021. The following table presents the fair value hierarchy for those assets measured at fair value on a recurring basis as of December 31, 2022 (in thousands): Fair Value Measurements at December 31, 2022 Assets (1) : Level 1 Level 2 Level 3 Total Commercial paper $ — $ 175,548 $ — $ 175,548 Corporate notes — 4,675 — 4,675 U.S. government and agency securities 75,212 — — 75,212 $ 75,212 $ 180,223 $ — $ 255,435 _____________________________________________ (1) As of December 31, 2022 , commercial paper investments of $131.1 million, U.S. government and agency securities of $4.0 million, and corporate notes of $2.0 million are included in cash and cash equivalents on the consolidated balance sheets, as the investments had a maturity of three months or less from the date of purchase on the consolidated balance sheets . The Company holds investments in marketable debt securities that are classified and accounted for as cash equivalents or available-for-sale and are remeasured on a recurring basis. All of the Company’s available-for-sale debt securities are classified on the consolidated balance sheet as cash equivalents or short-term investments. The following table summarizes the Company’s cash equivalents and investments in available-for-sale debt securities by significant investment category as of December 31, 2022 (in thousands): Cost Unrealized gains Unrealized losses Fair value Cash equivalents: Commercial paper $ 131,075 $ — $ — $ 131,075 Corporate notes 2,013 — — 2,013 U.S. government and agency securities 3,982 — — 3,982 Total cash equivalents $ 137,070 $ — $ — $ 137,070 Short-term investments: Commercial paper $ 44,473 $ — $ — $ 44,473 Corporate notes 2,664 — (2) 2,662 U.S. government and agency securities 71,342 6 (118) 71,230 Total short-term investments $ 118,479 $ 6 $ (120) $ 118,365 Total $ 255,549 $ 6 $ (120) $ 255,435 Foreign Currency Translation The functional currencies of the Company’s subsidiaries are currencies other than the U.S. dollar. The Company translates assets and liabilities of the foreign subsidiaries into U.S. dollars at the exchange rate in effect on the balance sheet date. Revenue and expenses of the subsidiaries are translated into U.S. dollars at the average exchange rate during the period. Gains or losses from these translation adjustments are reported as a separate component of stockholders’ equity in accumulated other comprehensive gain or loss until there is a sale or complete or substantially complete liquidation of the Company’s investment in the foreign subsidiary at which time the gains or losses will be realized and included in net income (loss). As of December 31, 2022 and 2021, all foreign currency translation gains (losses) have been unrealized and included in accumulated other comprehensive loss. Accumulated other comprehensive loss consists entirely of losses or gains from translation of foreign subsidiaries at December 31, 2022 and 2021. Inventory, Net Inventories are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. The Company reduces the carrying value of inventories for items that are potentially excess, obsolete, or slow-moving based on changes in customer demand, technology developments, or other economic factors. The Company capitalizes inventory produced for commercial sale. The Company capitalizes manufacturing costs as inventory following both the receipt of regulatory approval from regulatory bodies and the Company’s intent to commercialize. Costs associated with developmental products prior to satisfying the Company’s inventory capitalization criteria are charged to research and development expenses as incurred. Products that have been approved by certain regulatory authorities may also be used in clinical programs to assess the safety and efficacy of the products for usage that have not been approved by the FDA or other regulatory authorities. The form of product utilized for both commercial and certain clinical programs that are identical are included as inventory with an “alternative future use” as defined in authoritative guidance. Component materials and purchased products associated with clinical development programs are included in inventory and charged to research and development expenses when the product enters the research and development process and no longer can be used for commercial purposes and, therefore, does not have an “alternative future use.” For products that are under development and have not yet been approved by regulatory authorities, purchased component materials are charged to research and development expenses when the inventory ownership transfers to the Company. The Company analyzes inventory levels to identify inventory that may expire prior to sale, inventory that has a cost basis in excess of its net realizable value, or inventory in excess of expected sales requirements. Although the manufacturing of the Company’s SNM systems is subject to strict quality control, certain batches or units of product may no longer meet quality specifications or may expire, which would require adjustments to the Company’s inventory values. The Company also applies judgment related to the results of quality tests that are performed throughout the production process, as well as the understanding of regulatory guidelines, to determine if it is probable that inventory will be saleable. These quality tests are performed throughout the pre- and post-production processes, and the Company continually gathers information regarding product quality for periods after the manufacturing date. The Company’s products currently have a maximum estimated shelf-life range of 12 to 36 months and based on sales forecasts, the Company expects to realize the carrying value of the product inventory. In the future, reduced demand, quality issues, or excess supply beyond those anticipated by management may result in a material adjustment to inventory levels, which would be recorded as an increase to cost of sales. The determination of whether inventory costs will be realizable or not requires estimates by the Company’s management. A critical input in this determination is future expected inventory requirements based on internal sales forecasts. Management then compares these requirements to the expiry dates of inventory on hand. To the extent that inventory is expected to expire prior to being sold, management will write down the value of inventory. As of December 31, 2022, the Company had $30.4 million, $5.7 million, and $19.7 million of finished goods inventory, work-in-process inventory and raw materials inventory, respectively, net of reserves of $0.5 million. As of December 31, 2021, the Company had $46.8 million, $2.8 million and $15.3 million of finished goods inventory, work-in-process inventory and raw materials inventory, respectively, net of reserves of $0.2 million. Customer and Vendor Concentration As of December 31, 2022 and 2021, there were no customers who accounted for over 10% of the Company’s consolidated accounts receivable. As of December 31, 2022 and 2021, there was one vendor and no vendor, respectively, who accounted for over 10% of the Company’s consolidated accounts payable. As of December 31, 2022, 2021, and 2020, there were no customers who accounted for over 10% of the Company’s consolidated net revenue. As of December 31, 2022, 2021, and 2020, there were three, three, and two vendors, respectively, who accounted for over 10% of the Company’s inventory-related purchases. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three Goodwill Goodwill represents the excess purchase price over the fair values of both tangible and intangible assets acquired less the liabilities assumed. Goodwill is tested for impairment at the reporting unit level by comparing the reporting unit’s carrying amount to the fair value of the reporting unit. The fair values are estimated using an income and discounted cash flow approach. The Company evaluates its goodwill on an annual basis in the fourth quarter or more frequently if it believes indicators of impairment exist. The Company assesses qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount or performs an annual impairment test. When tested quantitatively, the Company compares the fair value of the applicable reporting unit with its carrying value. In making this assessment, management relies on a number of factors, including expected future operating results, business plans, economic projections, anticipated future cash flows, business trends and declines in the Company’s market capitalization. The Company estimates the fair value of its reporting unit using a combination of the discounted cash flow and income approaches. If the carrying amount of a reporting unit exceeds the reporting unit’s fair value, the amount by which the carrying value exceeds the fair value is recognized as an impairment loss. During the year ended December 31, 2022, the Company did not record any impairment charges related to goodwill. Intangible Assets Patent license asset The intangible asset represents exclusive rights to an additional field-of-use on the patent suite within the License Agreement with AMF. The additional field-of-use was provided in exchange for 50,000 shares of Series A preferred stock, the fair value of which was $1.0 million in 2013. The intangible asset was recorded at its fair value of $1.0 million at the date contributed. In connection with the IPO, such shares of Series A preferred stock were converted into common stock. Amortization of this asset is recorded over the shorter of the patent or legal life on a straight-line basis. The weighted-average amortization period is 8.71 years. The asset has been fully amortized as of December 31, 2022. For additional information, see Note 3. Exclusive license asset The intangible asset represents exclusive rights to existing technologies and development services from Micro Systems Engineering |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consists of the following (in thousands) at: December 31, 2022 2021 Equipment $ 2,645 $ 2,429 Computer hardware and software 3,282 2,450 Tools and molds 1,735 1,579 Leasehold improvements 4,449 4,372 Furniture and fixtures 1,810 1,502 Construction in progress 413 127 14,334 12,459 Less: accumulated depreciation and amortization (7,536) (5,544) $ 6,798 $ 6,915 Depreciation and amortization expense of property and equipment was $2.3 million, $1.9 million, and $1.6 million for the years ended December 31, 2022, 2021, and 2020, respectively. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The change in the carrying amount of goodwill during the years ended December 31, 2022 and 2021 included the following (in thousands): December 31, 2020 $ — February 25, 2021 Acquisition 109,786 Foreign currency translation adjustment (4,276) December 31, 2021 105,510 Foreign currency translation adjustment (11,096) December 31, 2022 $ 94,414 Intangible assets as of December 31, 2022 included the following (in thousands): December 31, 2022 Weighted-Average Amortization Period Gross Carrying Amount Accumulated Amortization Impairment Foreign currency translation adjustment Intangible Assets, Net Patent license asset 8.71 years $ 1,000 $ (1,000) $ — $ — $ — Exclusive license asset 4 years 3,300 (1,540) — — 1,760 Technology 12 years 81,100 (12,496) — (9,141) 59,463 Trade names and trademarks Indefinite 19,700 — — (2,398) 17,302 Customer relationships 12 years 11,400 (2,393) (287) (992) 7,728 $ 116,500 $ (17,429) $ (287) $ (12,531) $ 86,253 Intangible asset as of December 31, 2021 included the following (in thousands): December 31, 2021 Weighted-Average Amortization Period Gross Carrying Amount Accumulated Amortization Foreign currency translation adjustment Intangible Assets, Net Patent license asset 8.71 years $ 1,000 $ (919) $ — $ 81 Exclusive license asset 4 years 3,300 (660) — 2,640 Technology 12 years 81,100 (5,668) (1,424) 74,008 Trade names and trademarks Indefinite 19,700 — (365) 19,335 Customer relationships 12 years 11,400 (799) (196) 10,405 $ 116,500 $ (8,046) $ (1,985) $ 106,469 The Company recorded expense for the amortization of intangible assets of $9.4 million, $7.2 million, and $0.1 million, respectively, during the years ended December 31, 2022, 2021, and 2020. The estimated future amortization expense as of December 31, 2022, is as follows (in thousands): 2023 $ 9,085 2024 8,962 2025 7,927 2026 7,783 2027 7,645 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases In August 2014, the Company entered into a five-year operating lease for approximately 12,215 square feet of office space beginning on November 1, 2014, and expiring on October 31, 2019. In June 2019, the lease was amended to extend the expiration date to October 31, 2020. In September 2020, the lease was amended to extend the expiration date to July 31, 2022, and in December 2021, the lease was amended to extend the expiration date to January 31, 2028. Upon the execution of the amendments, which were deemed to be a lease modification, the Company reassessed the lease liability using the incremental borrowing rate for a collateralized asset of the same remaining term at the modification date and recorded ROU assets for the same amount. The Company also reassessed the lease classification and concluded that the lease continues to be an operating lease. Under the terms of the lease, the Company is responsible for taxes, insurance, and maintenance expense. The lease contains certain scheduled rent increases. Rent expense is recognized on a straight-line basis over the expected lease term. The Company entered into an operating lease for approximately 25,548 square feet of office space beginning on August 1, 2018, and expiring on October 31, 2027. Under the terms of the lease, the Company is responsible for taxes, insurance, and maintenance expense. The lease contains certain scheduled rent increases. Rent expense is recognized on a straight-line basis over the expected lease term. The Company has a renewal option to extend the term of the lease for a period of five years beyond the initial term. Under the terms of the lease, the base rent payable with respect to each renewal term will be equal to the prevailing market rental rent as of the commencement of the applicable renewal term. In the event of a default of certain of the Company’s obligations under the lease, the Company’s landlord would have the right to terminate the lease. In June 2019, the Company entered into an eight-year operating lease for approximately 32,621 square feet of office space beginning on January 15, 2020 and expiring on January 31, 2028. The Company uses these premises as its new principal executive offices and for general office space. The Company is utilizing its other currently-leased spaces to conduct the training of its sales team and for manufacturing purposes. Under the terms of the lease, the Company is responsible for taxes, insurance, and maintenance expense. The lease contains certain scheduled rent increases. Rent expense is recognized on a straight-line basis over the expected lease term. The Company has a renewal option to extend the term of the lease for a period of five years beyond the initial term. Under the terms of the lease, the base rent payable with respect to each renewal term will be equal to the prevailing market rental rent as of the commencement of the applicable renewal term. In the event of a default of certain of the Company’s obligations under the lease, the Company’s landlord would have the right to terminate the lease. In August 2020, the Company entered into a 38-month operating lease for approximately 5,693 square feet of warehouse space beginning on October 15, 2020 and expiring on December 31, 2023. The Company uses these premises for general warehouse space. In March 2022, the Company entered into an 18-month operating lease for approximately 3,276 square feet of warehouse space beginning on July 1, 2022 and expiring on December 31, 2023. The Company uses these premises for general warehouse space. During the years ended December 31, 2022, 2021, and 2020, ROU assets obtained in exchange for new operating lease liabilities were $0.1 million, $1.0 million, and $3.8 million, respectively. As of December 31, 2022 and 2021, the ROU assets had a balance of $6.2 million and $7.1 million, respectively. The operating lease ROU assets are included within the Company’s non-current other assets Total lease costs for the years ended December 31, 2022, 2021, and 2020 are as follows (in thousands): December 31, 2022 2021 2020 Lease cost Operating lease cost $ 2,131 $ 2,107 $ 1,991 Short-term lease cost 80 95 95 Variable lease cost 203 191 179 Total lease cost $ 2,414 $ 2,393 $ 2,265 Payments of operating lease liabilities as of December 31, 2022, are as follows (in thousands): 2023 $ 2,162 2024 2,066 2025 2,150 2026 2,239 2027 2,165 Thereafter 115 10,897 Less: imputed interest (1,780) 9,117 Less: operating lease liability, current portion (1,562) Operating lease liability, net of current portion $ 7,555 License Agreement In October 2013, the Company entered into the License Agreement, pursuant to which AMF, a Company stockholder, licensed the Company certain patents and know-how (collectively, the AMF IP) relating to, in relevant part, an implantable pulse generator and related system components in development by AMF as of that date, in addition to any peripheral or auxiliary devices, including all components, that when assembled, comprise such device, excluding certain implantable pulse generators (collectively, the AMF Licensed Products). Under the License Agreement, for each calendar year beginning in 2018, the Company is obligated to pay AMF a royalty on an AMF Licensed Product-by-AMF Licensed Product basis if one of the following conditions applies: (i) one or more valid claims within any of the patents licensed to the Company by AMF covers such AMF Licensed Products or the manufacture of such AMF Licensed Products or (ii) for a period of 12 years from the first commercial sale anywhere in the world of such AMF Licensed Product, in each case. The foregoing royalty is calculated as the greater of (a) 4% of all net revenue derived from the AMF Licensed Products, and (b) the Minimum Royalty, payable quarterly. The Minimum Royalty automatically increases each year after 2018, subject to a maximum amount of $200,000 per year. The Company recorded related royalties of $3.3 million, $6.3 million, and $4.4 million during the years ended December 31, 2022, 2021, and 2020, respectively. Royalty expense is included in operating expenses in the consolidated statements of comprehensive loss. Accrued royalties of $0.6 million and $1.8 million as of December 31, 2022 and 2021, respectively, are included within accrued liabilities in the Company’s consolidated balance sheets. Royalty expense is declining because the Company’s F15 recharge-free SNM device is not covered by any AMF patents licensed to the Company and is therefore not an AMF Licensed Product that requires the payment of a royalty to AMF. Legal Matters On November 4, 2019, Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (collectively, the Medtronic Affiliates) filed a complaint against the Company in the U.S. District Court for the Central District of California, Case No. 8:19-cv-2115, and amended the complaint on November 26, 2019. The Company refers to this matter as the Medtronic Litigation. The complaint asserts that the Company’s rechargeable SNM system infringes U.S. Patent Nos. 8,036,756, 8,626,314, 9,463,324 and 9,821,112 held by the Medtronic Affiliates, and the amended complaint further includes the additional patents 8,738,148; 8,457,758; and 7,774,069 (collectively, the Medtronic Patents). The Medtronic Litigation requests customary remedies for patent infringement, including (i) a judgment that the Company has infringed and is infringing the Medtronic Patents, (ii) damages, including treble damages for willful infringement, (iii) a permanent injunction preventing the Company from infringing the Medtronic Patents, (iv) attorneys’ fees, and (v) costs and expenses. The Company believes the allegations are without merit and is vigorously defending itself against them. The Company is unable to predict the likelihood of success of the claims of the Medtronic Affiliates against the Company or to quantify any risk of loss. The Medtronic Litigation could last for an extended period of time and require the Company to dedicate significant financial resources and management resources to its defense. An adverse ruling against the Company could materially and adversely affect its business, financial position, results of operations or cash flows and could also result in reputational harm. Even if the Company is successful in defending against these claims, the Medtronic Litigation could result in significant costs, delays in future product developments, reputational harm or other collateral consequences. The Company is currently engaged in discovery in the Medtronic Litigation. A jury trial is scheduled in the Medtronic Litigation for April 2023. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt In February 2018, the Company entered into the Loan and Security Agreement with Silicon Valley Bank, providing for a term loan (the Term Loan). In January 2021, the principal amount, accrued interest, accrued loan fees, and prepayment fees related to the Term Loan were paid in full. The unamortized debt issuance costs of $0.4 million were expensed and recognized as interest expense. In February 2021, the Company entered into another Loan and Security Agreement (the Loan and Security Agreement) with Silicon Valley Bank, under which the Company obtained a loan in the principal amount of $75 million. In June 2021, the principal amount, accrued interest, accrued loan fees, and prepayment fees related to this loan were paid in full. The unamortized debt issuance costs of $4.4 million were expensed and recognized as interest expense. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Preferred Stock As of December 31, 2022, the Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share. No preferred stock is issued or outstanding as of December 31, 2022. Common Stock The following summarizes the rights of holders of our common stock: Voting The holders of our common stock are entitled to one vote per share. The number of authorized shares of common stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the voting power of our capital stock entitled to vote, irrespective of the provisions of Section 242(b)(2) of the DGCL. Dividends Subject to preferences that may be applicable to the holders of outstanding shares of preferred stock and subject to applicable law, dividends may be declared and paid on the holders of our common stock when and as determined by our board of directors out of assets legally available for dividends. As a Delaware corporation, the Company will be subject to certain restrictions on dividends under the DGCL. Generally, a Delaware corporation may only pay dividends either out of “surplus” or out of the current or the immediately preceding year’s net profits. Surplus is defined as the excess, if any, at any given time, of the total assets of a corporation over its total liabilities and statutory capital. The value of a corporation’s assets can be measured in a number of ways and may not necessarily equal their book value. Liquidation Rights Upon our voluntary or involuntary liquidation, dissolution or winding up, after satisfaction of all our liabilities and the payment of any liquidation preference of any outstanding preferred stock, the holders of shares of common stock will be entitled to share in all of our assets legally remaining for distribution after payment of all debt and other liabilities, subject to preferences that may be applicable to the holders of outstanding shares of preferred stock. Redemption Rights There are no redemption or sinking fund provisions applicable to our common stock. Preemptive Rights and Conversion Rights There are no preemptive or conversion rights applicable to our common stock. Stock-Based Compensation Expense Stock-based compensation expense included in the Company’s consolidated statements of comprehensive loss is allocated as follows (in thousands): Years Ended December 31, 2022 2021 2020 Research and development $ 6,734 $ 5,980 $ 3,457 General and administrative 7,965 8,079 5,852 Sales and marketing 17,319 11,105 5,786 $ 32,018 $ 25,164 $ 15,095 Stock Option Activity 2014 Stock Option Plan In 2014, the Company established its 2014 Stock Option Plan (the 2014 Plan), which provides for the granting of stock options to employees, directors, and consultants of the Company. The 2018 Omnibus Incentive Plan was adopted upon our IPO and replaced the 2014 Stock Option Plan for future grants. As of December 31, 2022 and 2021, there were no stock options available for grant under the 2014 Plan. 2018 Omnibus Incentive Plan On October 18, 2018, the Company adopted the 2018 Omnibus Incentive Plan (the 2018 Plan), under which the Company may grant cash and equity incentive awards to eligible service providers to attract, motivate and retain the talent for which it competes. The 2018 Plan provides for awards based on shares of the Company’s common stock. Subject to adjustment by the Company’s board of directors, the total number of shares authorized to be awarded under the 2018 Plan may not exceed 7,088,581. As of December 31, 2022 and 2021, there were 2,694,622 and 950,354 shares available for grant under the 2018 Plan, respectively. The Company had shares of common stock reserved for future issuance as follows at: December 31, 2022 2021 Options outstanding under the 2014 Plan 184,104 277,505 Options and restricted stock units outstanding under the 2018 Plan 1,045,924 1,400,851 Options and restricted stock-based awards remaining under the 2018 Plan for future issuance 2,694,622 950,354 3,924,650 2,628,710 The fair value of each stock option is measured as of the date of grant, and compensation expense is recognized over the period during which the recipient renders the required services to the Company (typically the vesting period). Stock-based compensation expense recognized is based on the estimated number of stock options that are expected to ultimately become exercisable. Forfeitures are estimated at the time of the grant and revised in subsequent periods to reflect differences between the estimates and the number of shares that become exercisable. The option awards issued under the 2014 and 2018 Plans were measured based on fair value. The Company’s fair value calculations were made using the Black-Scholes option pricing model with the following assumptions: Years Ended December 31, 2022 2021 2020 Expected term (in years) — 5.46 - 6.00 6.05 Stock volatility — 63.49% 72.01% Risk-free interest rate — 0.53% - 1.16% 1.37% Dividend rate — — — The Company used the simplified method of determining the expected term of stock options as the Company believes this represents the best estimate of the expected term of a new option. The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company did not have sufficient trading history for the Company’s common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the Company’s common stock becomes available. The risk-free interest rate assumption is based on the U.S. Treasury instruments, whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The assumptions regarding the expected term of the options and the expected volatility of the stock price are subjective, and these assumptions have a significant effect on the estimated fair value amounts. There were no stock option grants for the year ended December 31, 2022. The weighted-average grant date fair value of options granted was $32.93 and $18.56 for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2022 and 2021, there was $1.8 million and $6.7 million, respectively, of total unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of approximately 1.0 year and 1.6 years, respectively. The following table summarizes stock option activity under the 2014 and 2018 Plans (in thousands, except share and per share data): Number of Options Weighted-Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at December 31, 2019 2,847,101 $ 13.22 Options granted 5,000 29.03 Options exercised (767,792) 5.05 $ 25,066 (1) Options forfeited (129,066) 20.20 Outstanding at December 31, 2020 1,955,243 16.01 Options granted 46,000 58.07 Options exercised (522,495) 12.60 $ 24,455 (1) Options forfeited (50,856) 29.64 Outstanding at December 31, 2021 1,427,892 18.13 Options exercised (364,352) 15.54 $ 18,251 (1) Options forfeited (16,930) 31.80 Outstanding at December 31, 2022 1,046,610 $ 18.81 $ 45,762 (2) Options exercisable at December 31, 2022 927,595 $ 17.68 $ 41,604 (2) _____________________________________________ (1) Represents the total difference between the Company’s closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. (2) Represents the total difference between the Company’s closing stock price on the last trading day of 2022 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2022. The amount of intrinsic value will change based on the fair market value of the Company’s stock. The weighted-average remaining contractual term of options outstanding and exercisable is 6.1 years and 6.9 years at December 31, 2022 and 2021, respectively. Restricted Shares Awards Activity As of December 31, 2022 and 2021, there was $54.0 million and $42.5 million, respectively, of total unrecognized compensation cost related to unvested restricted shares awards that is expected to be recognized over a weighted-average period of approximately 2.3 years and 3.0 years, respectively. The following table summarizes restricted shares awards activity: Number of Restricted Shares Awards Weighted-Average Fair Value Per Share at Grant Date Outstanding at December 31, 2019 586,166 $ 23.59 Restricted shares awards granted 502,500 37.68 Restricted shares awards vested (174,890) 23.29 Restricted shares awards forfeited (96,593) 28.83 Outstanding at December 31, 2020 817,183 31.70 Restricted shares awards granted 638,936 57.90 Restricted shares awards vested (235,560) 31.19 Restricted shares awards forfeited (118,525) 40.33 Outstanding at December 31, 2021 1,102,034 46.07 Restricted shares awards granted 683,354 56.69 Restricted shares awards vested (351,946) 42.15 Restricted shares awards forfeited (112,576) 50.50 Outstanding at December 31, 2022 1,320,866 $ 52.23 Restricted Stock Units Activity As of December 31, 2022 and 2021, there was $1.3 million and $1.9 million, respectively, of total unrecognized compensation cost related to unvested restricted stock units that is expected to be recognized over a weighted-average period of approximately 0.8 years and 0.9 years, respectively. The following table summarizes restricted stock units activity: Number of Restricted Stock Units Weighted-Average Fair Value Per Share at Grant Date Outstanding at December 31, 2019 248,104 $ 21.48 Restricted stock units granted 8,000 29.03 Restricted stock units vested (46,336) 14.19 Restricted stock units forfeited (2,667) 14.19 Outstanding at December 31, 2020 207,101 23.49 Restricted stock units granted 212,417 43.62 Restricted stock units vested (169,054) 19.89 Outstanding at December 31, 2021 250,464 42.99 Restricted stock units granted 201,884 38.75 Restricted stock units vested (268,930) 35.88 Outstanding at December 31, 2022 183,418 $ 48.74 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of net (loss) income before income tax expense were as follows (in thousands): Years Ended December 31, 2022 2021 2020 Domestic $ (24,466) $ (56,105) $ (54,994) Foreign (37,850) (23,180) 80 Total $ (62,316) $ (79,285) $ (54,914) The components of the income tax expense (benefit) were as follows (in thousands): Years Ended December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State 76 211 1 Foreign 174 26 — Total current income tax expense $ 250 $ 237 $ 1 Deferred: Federal $ — $ (422) $ — State — (117) — Foreign (2,868) 1,084 — Total deferred income tax (benefit) expense $ (2,868) $ 545 $ — Total $ (2,618) $ 782 $ 1 The reconciliation between the Company’s effective tax rate and the statutory tax rate is as follows: Years Ended December 31, 2022 2021 2020 Tax at statutory federal rate 21.0 % 21.0 % 21.0 % State tax, net of federal benefit 1.0 % 3.8 % 7.0 % Excess tax benefits related to stock-based compensation 8.3 % 9.4 % 10.3 % Non-deductible stock-based compensation (1.7) % (1.4) % — % Tax rate change 1.0 % (5.2) % — % Net operating loss adjustments — % (7.9) % — % Section 382 limitation — % — % — % R&D tax credit, net of reserve 4.1 % 6.1 % (4.5) % Change in valuation allowance (19.6) % (24.5) % (36.8) % Change in fair value of contingent consideration (7.3) % — % — % Other (2.6) % (2.3) % 3.0 % Effective tax rate 4.2 % (1.0) % — % Our effective tax rate was 4.2% for the year ended December 31, 2022, compared to an effective tax rate of (1.0)% for the year ended December 31, 2021 and 0.0% for the year ended December 31, 2020. The effective tax rates for the periods presented are primarily comprised of U.S. and foreign statutory taxes, excess tax benefits related to stock-based compensation, change in foreign statutory income tax rates, change in fair value of the contingent consideration, and a change in valuation allowance. The difference in the effective tax rate of 4.2% for the year ended December 31, 2022 as compared to the effective tax rate of (1.0)% for the year ended December 31, 2021 was primarily due to higher net operating loss adjustments and change in valuation allowance during the year ended December 31, 2021. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands) as of: December 31, 2022 2021 Deferred Tax Assets: Stock-based compensation $ 4,855 $ 5,367 Depreciation and amortization (196) 7 Lease liabilities 2,169 895 Net operating loss carryforwards 76,013 74,744 Research and development credit carryforwards 7,332 4,865 Interest expense limitation carryforwards 5,457 2,518 Other 10,209 2,895 Total deferred tax assets 105,839 91,291 Less: valuation allowance (96,751) (85,061) Total net deferred tax assets $ 9,088 $ 6,230 Deferred Tax Liabilities: ROU assets $ (1,464) $ — Intangibles (24,036) (25,447) Total deferred tax liabilities $ (25,500) $ (25,447) Net deferred tax liabilities $ (16,412) $ (19,217) At December 31, 2022, the Company had U.S. federal and foreign net operating loss (NOL) carryforwards of approximately $270.3 million and $9.6 million, respectively. Of the U.S. federal NOLs, $51.5 million will expire between 2033 and 2037 and the remainder will carryover indefinitely. The Company had U.S. state NOLs of $254.6 million, which will expire between 2033 and 2042. Under California Assembly Bill 85, effective June 29, 2020, net operating loss deductions were suspended for tax years beginning in 2020, 2021, and 2022 and the carry forward periods of any net operating losses not utilized due to such suspension were extended. The foreign net operating loss carryforwards have an indefinite carryforward period. The Company accounts for income taxes according to ASC 740, “Income Taxes.” The Company periodically evaluates whether a portion or all of its deferred tax assets will be recovered. The Company records a valuation allowance against deferred tax assets if and to the extent it is more likely than not that they will not be recovered. In evaluating the need for a valuation allowance, the Company weighs all relevant positive and negative evidence, including among other factors, historical financial performance, forecasts of income over the applicable carryforward periods, and the market environment, with each consideration weighted based on its reliability. The Company continues to maintain a full valuation allowance against its otherwise recognizable U.S. deferred income tax assets as of December 31, 2022 and 2021. The Company has determined, after evaluating all positive and negative historical and prospective evidence, that it is more likely than not that the deferred income tax assets will not be realized. The valuation allowance increased by $11.7 million for the year ended December 31, 2022, from $85.1 million to $96.8 million. This increase in the valuation allowance during the year ended December 31, 2022, was largely attributable to losses incurred in the U.S. jurisdiction. The Company’s NOL carryforwards were generated from domestic and foreign operations. Pursuant to Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Internal Revenue Code), use of the Company’s NOL carryforwards may be limited if the Company experiences a cumulative change in ownership of greater than 50% in a rolling three-year period. The Company performed an analysis of changes in ownership for purposes of these Internal Revenue Code sections. Based on the study performed in 2020, the Company determined that an ownership change occurred in 2014, 2018 and 2019. The total reduction to the net operating loss carryforwards and R&D credit was $12.2 million and $1.5 million, respectively. Based on the studies performed in 2022 and 2021, the Company determined that an ownership change did not occur in 2022 and 2021. The total reduction of the net operating loss carryforwards was offset by valuation allowance, and there was no impact to tax expense related to the limitation. Future ownership changes could impact the Company’s ability to utilize NOL carryforwards. The Company applies the provisions of FASB ASC 740-10, “Accounting for Uncertainty in Income Taxes.” ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or are expected to be taken on a tax return. The Company has identified unrecognized tax benefits or uncertain tax positions. There has been a liability on uncertain tax positions recorded on the financial statements as of December 31, 2022. The Company does not expect that its assessment regarding unrecognized tax benefits and uncertain tax positions will materially change over the following 12 months. A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows (in thousands): Balance at December 31, 2020 $ 2,491 Additions based on tax positions related to the current year 528 Additions from business combination 1,782 Deductions for tax positions taken in prior years (1,397) Balance at December 31, 2021 3,404 Additions based on tax positions related to the current year 574 Deductions for tax positions taken due to settlement (1,603) Balance at December 31, 2022 $ 2,375 As of December 31, 2022, the total unrecognized tax benefits was $2.4 million, of which, if recognized, $0.1 million would affect the annual effective tax rate. Due to the conclusion of foreign statutory audits, there was a release of uncertain tax positions. There were no interest or penalties to be recognized for the tax years ended December 31, 2022 and 2020. As of December 31, 2021, the Company has accumulated $0.4 million in both interest and penalties associated with uncertain tax positions. The Company has net operating loss and research and development credit carryforwards which may be subject to examination by taxing authorities. As of December 31, 2022, tax years beginning with the year ended December 31, 2018 remain subject to examination by the Internal Revenue Service and certain U.S. state jurisdictions. As of December 31, 2022, tax years beginning with the years ended December 31, 2016, December 31, 2018, and December 31, 2018 remain subject to examination by the German, French, and the U.K. tax authorities, respectively. The Company is not currently under audit by any taxing authority. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit PlanThe Company sponsors a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan covers all U.S. employees who meet minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pre- or post-tax basis. Contributions to the plan by the Company may be made at the discretion of the board of directors. During the years ended December 31, 2022, 2021, and 2020, the Company contributions to the plan amounted to $2.1 million, $1.9 million, and $1.6 million, respectively. |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisition | Acquisition On February 25, 2021, the Company acquired all issued and outstanding shares of Contura Limited (Contura) through a Share Purchase Agreement. As a result of the acquisition, the Company acquired a 100% equity interest in Contura. The Company accounted for the acquisition as a business combination pursuant to ASC 805, “Business Combinations”. In accordance with ASC 805, fair values are assigned to tangible and identifiable intangible assets acquired and liabilities assumed at the acquisition date based on the information that was available as of the acquisition date. The Company believes that the information available provides a reasonable basis for estimating the fair values of assets acquired and liabilities assumed for the acquisition. The purchase price consideration for the acquisition totaled $204.7 million, of which $141.4 million was in the form of cash and $55.7 million was in the form of 1,096,583 shares of the Company’s common stock. Additionally, a payment of $35 million may be paid to Contura if the Company is able to generate $50 million in Bulkamid sales within a 12-month period before December 31, 2024. As the additional payment is contingent on future sales, an estimate of fair value was initially assessed to be $7.6 million which was considered part of the purchase price consideration and was recorded as other long-term liabilities in the consolidated balance sheet. The cash consideration paid for the acquisition was funded by existing cash on hand. The following table presents the purchase price allocation of Contura assets acquired and liabilities assumed, based on their estimated fair values as of the February 25, 2021 acquisition date (in thousands): Purchase Price Allocation Assets Acquired Cash and cash equivalents $ 593 Accounts receivable 1,688 Inventory 988 Prepaid expenses and other current assets 115 Property and equipment 52 Other assets 108 Intangible assets 112,200 Total assets acquired 115,744 Liabilities Assumed Accounts payable 209 Accrued liabilities 820 Accrued compensation and benefits 315 Lease liability 86 Debt 122 Deferred tax liabilities 19,286 Total liabilities assumed 20,838 Net assets acquired 94,906 Purchase price consideration 204,692 Goodwill $ 109,786 Intangible assets Identified intangible assets consist of technology, trade names and trademarks, and customer relationships. The fair value of intangible assets and the determination of their respective useful lives were made in accordance with ASC 805 and are outlined in the table below: Fair Value Useful Life Technology $ 81,100 12 years Trade names and trademarks $ 19,700 Indefinite Customer relationships $ 11,400 12 years Intangible assets were valued using models and approaches best suited for the asset type. Technology was valued using the Multi-Period Excess Earnings Method (MPEEM), which calculates economic benefits by determining the income attributable to an intangible asset after returns are subtracted for contributory assets. Assumptions in the MPEEM include projected revenue growth rates, future margins, royalty rate indication, and tax rate. Trade names and trademarks were valued using the Relief from Royalty Method. The relief from royalty method is a variant of the discounted cash flow method, which is a form of the income approach. It is based on the premise that ownership of the intangible asset relieves the need to pay a licensing fee for the ability to use the asset. Assumptions include a discount rate, tax rate, royalty rate indication, long-term growth rate, and implied profit split time period. Customer relationships were valued using the distributor method. The distributor method was utilized as the asset was determined to be a secondary intangible asset and the Company’s product could be sold through distributors. Assumptions used in the distributor method include projected revenue growth rates, future margins, rate of customer retention, and an appropriate discount rate. Intangible assets will be amortized based on their useful life. $8.4 million and $6.5 million in amortization expense relating to these intangible assets was recognized during the years ended December 31, 2022 and 2021, respectively, in the consolidated statements of comprehensive loss. The unamortized balance as of December 31, 2022 and 2021 was $84.5 million and $103.7 million, respectively. The total weighted-average original amortization period for the acquired finite-lived intangible assets is 12 years. Goodwill Goodwill is calculated as the excess of the consideration transferred over the fair value of the identifiable net assets acquired in a business combination and represents the future economic benefits expected to arise from anticipated synergies and intangible assets acquired that do not qualify for separate recognition, including an assembled workforce, noncontractual relationships, and other agreements. As an indefinite-lived asset, goodwill is not amortized but rather is subject to impairment testing on at least an annual basis. The Contura acquisition resulted in the recognition of $109.8 million of goodwill, which is not expected to be deductible for tax purposes. Contingent consideration As part of the transaction, the Company agreed to pay Contura $35 million if Bulkamid sales achieve $50 million in any 12-month period before December 31, 2024. The preliminary fair value of the estimated contingent consideration was determined by using a binary option-based approach. Inputs used in the assessment include the Company’s projected revenue rate, an appropriate discount rate, volatility, and risk-free rate. The estimated fair value of the contingent consideration was preliminarily determined to be $6.8 million. After the March 31, 2021 interim financial statements were issued, the Company received a final valuation report from a third-party valuation firm relating to the contingent consideration. After considering the results of that valuation report, the Company estimated the fair value of the contingent consideration to be $7.6 million as of the acquisition date. As a result, the fair value of the contingent consideration increased by $0.8 million with a corresponding increase to goodwill. To the extent that the forecast milestone achievements probabilities changed, future fair value measurement adjustments to the contingent consideration liability will be recognized in the consolidated statements of comprehensive loss. Deferred tax liabilities The Company determined the fair value of the deferred tax liabilities related to the acquisition to be $19.3 million. Transaction-related costs Acquisition costs are not included as components of consideration transferred and instead are accounted for as expenses in the period in which the costs are incurred. The Company incurred $4.4 million of acquisition-related costs in the first quarter of fiscal year 2021. Pro forma (Unaudited) The following unaudited pro forma financial information presents the consolidated results of operations of the Company with Contura for the years ended December 31, 2021 and 2020, as if the acquisition had occurred on January 1, 2020 instead of February 25, 2021 (in thousands, except share and per share data). Contura’s revenue and net loss for the year ended December 31, 2021 were $24.1 million and $2.8 million, respectively, of which $22.7 million in revenue and $2.2 million in net income was recognized after the February 25, 2021 acquisition date. Revenue and net income recognized after the acquisition date were recorded within the Company’s consolidated statements of comprehensive loss. The pro forma information does not necessarily reflect the results of operations that would have occurred had the entities been a single company during the respective periods. Years Ended December 31, 2021 2020 Net revenue $ 181,643 $ 122,444 Net loss $ (77,535) $ (63,183) Net loss per share, basic and diluted $ (1.79) $ (1.66) Weighted-average shares used to compute basic and diluted net loss per share 43,237,536 38,077,918 The unaudited pro forma financial information above reflects the following pro forma adjustments: • An adjustment to decrease net loss for the year ended December 31, 2021 by $4.4 million to eliminate integration and acquisition related costs incurred by the Company and Contura and a corresponding increase to net loss for the year ended December 31, 2020 by $4.4 million to give effect to the integration and acquisition of Contura as if it had occurred on January 1, 2020. • An adjustment to increase net loss for the year ended December 31, 2021 by $1.3 million and a corresponding increase to net loss for the year ended December 31, 2020 by $7.8 million to reflect amortization of the fair value adjustments for intangible assets as if the assets were acquired January 1, 2020. |
Nature of Operations and Summ_2
Nature of Operations and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company; its wholly-owned subsidiaries: Axonics Europe, S.A.S., Axonics Modulation Technologies U.K. Limited, Axonics Modulation Technologies Australia Pty Ltd, Axonics Women’s Health Limited, Bulkamid SARL, Axonics GmbH, and Contura, Inc. Intercompany accounts and transactions have been eliminated in consolidation. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). Certain prior year reported amounts have been reclassified to conform with the 2022 presentation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses, and related disclosure of contingent assets and liabilities. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. The results of this evaluation then form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates and such differences may be material to the consolidated financial statements. Significant items subject to such estimates and assumptions include the useful lives of property and equipment and intangible assets, the valuation of deferred income tax assets and |
Revenue Recognition | Revenue Recognition Revenue recognized during the years ended December 31, 2022, 2021, and 2020 relates entirely to the sale of the Company’s products to its customers and distributors. The Company has revenue arrangements that consist of a single performance obligation. The Company recognizes revenue at the point in time when it transfers control of promised goods to its customers. Revenue is measured as the amount of consideration it expected to be received in exchange for transferring goods. The amount of revenue that is recognized is based on the transaction price, which represents the invoiced amount and includes estimates of variable consideration such as discounts, where applicable. The Company also sells to distributors and applies the same policies as its revenue arrangements with customers, specifically that revenue is recognized at the point in time when it transfers control of promised goods to its distributors. The Company does not offer rights of return or price protection. The amount of variable consideration included in the transaction price may be constrained and is included only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Payment terms, typically less than three months, do not include a significant financing component. The Company extends credit to its customers and distributors based upon an evaluation of their financial condition and credit history and generally requires no collateral. The Company does not have any contract balances related to product sales. The Company also does not have significant contract acquisition costs related to product sales. In accordance with Company policy and based on the Company’s historical experience, the allowance for product returns was $0.2 million and $0.2 million at December 31, 2022 and 2021, respectively, and is recorded as a reduction of gross revenue in its consolidated statements of comprehensive loss. Damaged or defective products are replaced at no charge under the Company’s standard warranty. For the years ended December 31, 2022, 2021, and 2020, the replacement costs were $0.2 million, $0.2 million, and $0.1 million, respectively. The replacement costs are recorded within the sales and marketing expenses in its consolidated statements of comprehensive loss. The Company offers its standard warranty to all customers. The Company does not sell any warranties on a standalone basis. The Company’s warranty provides that its products are free of material defects and conform to specifications, and includes an offer to repair, replace or refund the purchase price of defective products. This assurance does not constitute a service and is not considered a separate performance obligation. The Company estimates warranty liabilities at the time of revenue recognition and records it as a charge to sales and marketing expense. The warranty liability as of December 31, 2022 and 2021 was $0.1 million and $0.1 million, respectively. Shipping and handling costs incurred for the delivery of goods to customers and distributors are included in cost of goods sold. Amounts billed to customers and distributors for shipping and handling are included in net revenue. |
Allowance for Credit Losses | Allowance for Credit Losses The Company makes estimates of the collectability of accounts receivable in accordance with ASU 2016-13, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The Company’s estimate of future credit losses is made by management based upon historical bad debts, customer receivable balances, age of customer receivable balances, customers’ financial conditions and reasonable forecasted economic trends. Despite the Company’s efforts to minimize credit risk exposure, customers could be adversely affected if future economic and industry trends, including those related to COVID-19, change in such a manner as to negatively impact their cash flows. The full effects of COVID-19 on the Company’s customers are highly uncertain and cannot be predicted. As a result, the Company’s future collection experience can differ significantly from historical collection trends. If the Company’s customers experience a negative impact on their cash flows, it could have a material adverse effect on the Company’s results of operations and financial condition. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash equivalents consist of short-term, highly liquid investments purchased with an original maturity of three months or less. Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. At times, the cash and cash equivalent balances may exceed federally insured limits. The Company does not believe that this results in any significant credit risk as the Company’s policy is to place its cash and cash equivalents in highly-rated financial institutions. The Company also holds cash in foreign banks that are not federally insured. The Company has not experienced any losses on its deposits of cash and cash equivalents. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined 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 three-level fair value hierarchy prioritizes the inputs used to measure fair value. The hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1: Inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: Inputs are quoted prices for similar assets and liabilities in active markets or quoted prices for identical or similar instruments in markets that are not active and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. • Level 3: Inputs are unobservable inputs based on the Company’s assumptions and valuation techniques used to measure assets and liabilities at fair value. The inputs require significant management judgment or estimation. Level 1 investments include U.S. government and agency securities, which are valued based on prices readily available in the active markets in which those securities are traded. Level 2 investments include commercial paper and corporate notes, which is valued on a recurring basis based on inputs that are readily available in public markets or can be derived from information available in publicly quoted markets. The Company’s assessment of the significance of an input to the fair value measurement requires judgment, which may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels. The carrying amounts reported in the consolidated financial statements approximate the fair value for cash and cash equivalents, accounts receivable, and accounts payables, due to their short-term nature. The purchase price of business acquisitions is primarily allocated to the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the acquisition date, with the excess recorded as goodwill. Certain of the Company’s business combinations involve potential payment of future consideration that is contingent upon the achievement of certain product development milestones and/or contingent on the acquired business reaching certain performance milestones. A liability is recorded for the estimated fair value of the contingent consideration on the acquisition date. The fair value of the contingent consideration is remeasured at each reporting period, and the change in fair value is recognized within operating expenses in the consolidated statements of comprehensive loss. On February 25, 2021, the Company acquired Contura Limited and its Bulkamid product, a urethral bulking agent indicated for the treatment of female SUI. In consideration for the acquisition, the Company paid approximately $141.3 million in cash and issued 1,096,583 shares of our common stock. The Company may pay an additional $35 million in the event Bulkamid sales in any consecutive 12-month period exceed $50 million (the Milestone) before December 31, 2024, with payment due within 50 business days following the quarter in which the Milestone has been met. |
Investment Securities | Investment Securities The Company classifies its investment securities as available-for-sale. Those investments in debt securities with maturities less than 12 months at the balance sheet date are considered short-term investments. Those investments in debt securities with maturities greater than 12 months at the balance sheet date are considered long-term investments. The Company’s investment securities classified as available-for-sale are recorded at fair value based on the fair value hierarchy (Level 1 and Level 2 inputs in the fair value hierarchy), and consists primarily of commercial paper, corporate notes and U.S. government and agency securities. Unrealized gains or losses, deemed temporary in nature, are reported as other comprehensive income (loss) within the consolidated statements of comprehensive loss. There were no unrealized gains or losses during the years ended December 31, 2022, 2021, and 2020. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to net income (loss) and the corresponding establishment of a credit loss allowance for the security. Premiums (discounts) are amortized (accreted) over the life of the related security as an adjustment to yield using the straight-line interest method. Dividend, accretion and interest income are recognized when earned. Realized gains or losses are included in net loss and are derived using the specific identification method for determining the cost of securities sold. |
Foreign Currency Translation | Foreign Currency Translation The functional currencies of the Company’s subsidiaries are currencies other than the U.S. dollar. The Company translates assets and liabilities of the foreign subsidiaries into U.S. dollars at the exchange rate in effect on the balance sheet date. Revenue and expenses of the subsidiaries are translated into U.S. dollars at the average exchange rate during the period. Gains or losses from these translation adjustments are reported as a separate component of stockholders’ equity in accumulated other comprehensive gain or loss until there is a sale or complete or substantially complete liquidation of the Company’s investment in the foreign subsidiary at which time the gains or losses will be realized and included in net income (loss). As of December 31, 2022 and 2021, all foreign currency translation gains (losses) have been unrealized and included in accumulated other comprehensive loss. Accumulated other comprehensive loss consists entirely of losses or gains from translation of foreign subsidiaries at December 31, 2022 and 2021. |
Inventory, Net | Inventory, Net Inventories are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. The Company reduces the carrying value of inventories for items that are potentially excess, obsolete, or slow-moving based on changes in customer demand, technology developments, or other economic factors. The Company capitalizes inventory produced for commercial sale. The Company capitalizes manufacturing costs as inventory following both the receipt of regulatory approval from regulatory bodies and the Company’s intent to commercialize. Costs associated with developmental products prior to satisfying the Company’s inventory capitalization criteria are charged to research and development expenses as incurred. Products that have been approved by certain regulatory authorities may also be used in clinical programs to assess the safety and efficacy of the products for usage that have not been approved by the FDA or other regulatory authorities. The form of product utilized for both commercial and certain clinical programs that are identical are included as inventory with an “alternative future use” as defined in authoritative guidance. Component materials and purchased products associated with clinical development programs are included in inventory and charged to research and development expenses when the product enters the research and development process and no longer can be used for commercial purposes and, therefore, does not have an “alternative future use.” For products that are under development and have not yet been approved by regulatory authorities, purchased component materials are charged to research and development expenses when the inventory ownership transfers to the Company. The Company analyzes inventory levels to identify inventory that may expire prior to sale, inventory that has a cost basis in excess of its net realizable value, or inventory in excess of expected sales requirements. Although the manufacturing of the Company’s SNM systems is subject to strict quality control, certain batches or units of product may no longer meet quality specifications or may expire, which would require adjustments to the Company’s inventory values. The Company also applies judgment related to the results of quality tests that are performed throughout the production process, as well as the understanding of regulatory guidelines, to determine if it is probable that inventory will be saleable. These quality tests are performed throughout the pre- and post-production processes, and the Company continually gathers information regarding product quality for periods after the manufacturing date. The Company’s products currently have a maximum estimated shelf-life range of 12 to 36 months and based on sales forecasts, the Company expects to realize the carrying value of the product inventory. In the future, reduced demand, quality issues, or excess supply beyond those anticipated by management may result in a material adjustment to inventory levels, which would be recorded as an increase to cost of sales. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three |
Goodwill | Goodwill Goodwill represents the excess purchase price over the fair values of both tangible and intangible assets acquired less the liabilities assumed. Goodwill is tested for impairment at the reporting unit level by comparing the reporting unit’s carrying amount to the fair value of the reporting unit. The fair values are estimated using an income and discounted cash flow approach. The Company evaluates its goodwill on an annual basis in the fourth quarter or more frequently if it believes indicators of impairment exist. The Company assesses qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount or performs an annual impairment test. When tested quantitatively, the Company compares the fair value of the applicable reporting unit with its carrying value. In making this assessment, management relies on a number of factors, including expected future operating results, business plans, economic projections, anticipated future cash flows, business trends and declines in the Company’s market capitalization. The Company estimates the fair value of its reporting unit using a combination of the discounted cash flow and income approaches. If the carrying amount of a |
Intangible Assets | Intangible Assets Patent license asset The intangible asset represents exclusive rights to an additional field-of-use on the patent suite within the License Agreement with AMF. The additional field-of-use was provided in exchange for 50,000 shares of Series A preferred stock, the fair value of which was $1.0 million in 2013. The intangible asset was recorded at its fair value of $1.0 million at the date contributed. In connection with the IPO, such shares of Series A preferred stock were converted into common stock. Amortization of this asset is recorded over the shorter of the patent or legal life on a straight-line basis. The weighted-average amortization period is 8.71 years. The asset has been fully amortized as of December 31, 2022. For additional information, see Note 3. Exclusive license asset The intangible asset represents exclusive rights to existing technologies and development services from Micro Systems Engineering, Inc. pursuant to an agreement entered into on March 2, 2021. The rights and services were provided in exchange for 65,594 shares of common stock, the fair value of which was $3.6 million upon transfer. The intangible asset was recorded at its fair value of $3.3 million at the date of the agreement, with the difference of $0.3 million recorded as a vendor credit in accounts payable in the consolidated balance sheets. Amortization of this asset is recorded over the four-year term of the agreement on a straight-line basis. The Company will review the intangible asset for impairment whenever an impairment indicator exists. There have been no intangible asset impairment charges to date. For additional information, see Note 3. Contura acquisition general and administrative expenses |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net cash flows that the assets are expected to generate. If said assets are considered to be impaired, the impairment that would be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. There have been $0.3 million of impairments of long-lived assets to date. Indefinite-lived intangible assets are tested for impairment annually in the fourth quarter of the fiscal year and whenever events or changes in circumstances indicate that the carrying amount may be impaired. Impairment is calculated as the excess of the asset’s carrying value over its fair value. Fair value is generally determined using a discounted future cash flow analysis. There have been no impairments to indefinite-lived intangible assets during the year ended December 31, 2022 |
Leases | Leases In accordance with Accounting Standards Update (ASU) No. 2016-02, “Leases (Topic 842),” components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. Rather, entities would account for each lease component and related non-lease component together as a single lease component. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only. Topic 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in Topic 842 to assist in evaluating leases for appropriate classification between operating and finance leases. The aforementioned bright lines are applied consistently to the Company’s entire portfolio of leases. Operating lease right-of-use (ROU) assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate, which is the rate for a fully collateralized amortizing loan with the same maturity as the lease term in similar economic environment, based on the information available at commencement date in determining the present value of future payments. The operating lease ROU assets also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. |
Research and Development | Research and Development Research and development costs are charged to operations as incurred. Research and development costs include salary and personnel-related costs, costs of clinical studies and testing, royalty expense, supplies and materials, and outside consultant costs. |
Advertising Expense | Advertising ExpenseThe Company expenses advertising costs as they are incurred. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method to compute the difference between the tax basis of assets and liabilities and the related financial amounts, using currently enacted tax rates. The Company has net deferred tax assets in certain jurisdictions. The realization of these deferred tax assets is dependent upon the Company’s ability to generate sufficient taxable income in future years. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount that more likely than not will be realized. The Company evaluates the recoverability of the deferred tax assets annually and maintains a full valuation allowance on its U.S. net deferred tax assets. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The Company is subject to transfer pricing and other tax regulations designed to ensure that appropriate levels of income are reported as earned by the Company’s U.S. and foreign entities and are taxed accordingly. In the normal course of business, the Company is audited by federal, state and foreign tax authorities, and subject to inquiries from those tax authorities regarding the amount of taxes due. These inquiries may relate to the timing and amount of deductions and the allocation of income among various tax jurisdictions. The Company’s policy is to recognize interest and penalties related to unrecognized tax benefits, if any, in income tax expense. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of employee and non-employee services in exchange for an award of equity instruments based on the grant-date fair value of the award and recognizes compensation cost over the requisite service period (typically the vesting period), generally three three |
Net Loss per Share of Common Stock | Net Loss per Share of Common Stock Basic net loss per share of common stock is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, unvested RSAs and RSUs are considered to be potentially dilutive securities. Because the Company has reported a net loss in all periods presented, diluted net loss per share of common stock is the same as basic net loss per share of common stock for those periods. |
Segment Reporting | Segment Reporting Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (CODM) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment, the development and commercialization of innovative and minimally invasive products to treat bladder and bowel dysfunction. Geographically, the Company sells over 90% of its products to customers in the United States. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements We have reviewed and considered all recent accounting pronouncements that have not yet been adopted and believe there are none that could potentially have a material impact on our business practices, financial condition, results of operations, or disclosures. |
Nature of Operations and Summ_3
Nature of Operations and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Revenue Disaggregated by Product and Geographic Market | The following table provides additional information pertaining to net revenue disaggregated by product and geographic market for the years ended December 31, 2022, 2021, and 2020 (in thousands): Years Ended December 31, 2022 2021 2020 SNM net revenue United States $ 216,861 $ 153,837 $ 107,542 International markets 5,130 3,753 3,993 $ 221,991 $ 157,590 $ 111,535 Bulkamid net revenue (1) United States $ 40,178 $ 12,660 $ — International markets 11,533 10,040 — $ 51,711 $ 22,700 $ — Total net revenue $ 273,702 $ 180,290 $ 111,535 _____________________________________________ (1) The acquisition of Bulkamid was completed on February 25, 2021. Reported revenue includes sales from February 26, 2021 onwards. |
Schedule of Changes in Allowance for Credit Losses | The following table summarizes the changes in our allowance for credit losses (in thousands): Years Ended December 31, 2022 2021 2020 Balance at beginning of period $ 355 $ 465 $ 75 Write-offs (75) (12) — Bad debt expense (recoveries) 41 (98) 390 Balance at end of period $ 321 $ 355 $ 465 |
Schedule of Changes in Fair Value of Liabilities Measured on Recurring Basis | The following table summarizes the changes in the fair value of recurring Level 3 fair value measurements during the years ended December 31, 2022 and 2021 (in thousands): Liabilities Contingent consideration: December 31, 2020 $ — February 25, 2021 Acquisition 7,630 Change in fair value included in earnings 2,740 December 31, 2021 10,370 Change in fair value included in earnings 22,230 December 31, 2022 $ 32,600 |
Schedule of Fair Value Hierarchy for Assets Measured on Recurring Basis | The following table presents the fair value hierarchy for those assets measured at fair value on a recurring basis as of December 31, 2022 (in thousands): Fair Value Measurements at December 31, 2022 Assets (1) : Level 1 Level 2 Level 3 Total Commercial paper $ — $ 175,548 $ — $ 175,548 Corporate notes — 4,675 — 4,675 U.S. government and agency securities 75,212 — — 75,212 $ 75,212 $ 180,223 $ — $ 255,435 _____________________________________________ (1) As of December 31, 2022 , commercial paper investments of $131.1 million, U.S. government and agency securities of $4.0 million, and corporate notes of $2.0 million are included in cash and cash equivalents on the consolidated balance sheets, as the investments had a maturity of three months or less from the date of purchase on the consolidated balance sheets . |
Schedule of Available-for-sale Debt Securities By Significant Investment Category | The following table summarizes the Company’s cash equivalents and investments in available-for-sale debt securities by significant investment category as of December 31, 2022 (in thousands): Cost Unrealized gains Unrealized losses Fair value Cash equivalents: Commercial paper $ 131,075 $ — $ — $ 131,075 Corporate notes 2,013 — — 2,013 U.S. government and agency securities 3,982 — — 3,982 Total cash equivalents $ 137,070 $ — $ — $ 137,070 Short-term investments: Commercial paper $ 44,473 $ — $ — $ 44,473 Corporate notes 2,664 — (2) 2,662 U.S. government and agency securities 71,342 6 (118) 71,230 Total short-term investments $ 118,479 $ 6 $ (120) $ 118,365 Total $ 255,549 $ 6 $ (120) $ 255,435 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following (in thousands) at: December 31, 2022 2021 Equipment $ 2,645 $ 2,429 Computer hardware and software 3,282 2,450 Tools and molds 1,735 1,579 Leasehold improvements 4,449 4,372 Furniture and fixtures 1,810 1,502 Construction in progress 413 127 14,334 12,459 Less: accumulated depreciation and amortization (7,536) (5,544) $ 6,798 $ 6,915 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Carrying Amount of Goodwill | The change in the carrying amount of goodwill during the years ended December 31, 2022 and 2021 included the following (in thousands): December 31, 2020 $ — February 25, 2021 Acquisition 109,786 Foreign currency translation adjustment (4,276) December 31, 2021 105,510 Foreign currency translation adjustment (11,096) December 31, 2022 $ 94,414 |
Schedule of Finite-Lived and Indefinite-Lived Intangible Assets | Intangible assets as of December 31, 2022 included the following (in thousands): December 31, 2022 Weighted-Average Amortization Period Gross Carrying Amount Accumulated Amortization Impairment Foreign currency translation adjustment Intangible Assets, Net Patent license asset 8.71 years $ 1,000 $ (1,000) $ — $ — $ — Exclusive license asset 4 years 3,300 (1,540) — — 1,760 Technology 12 years 81,100 (12,496) — (9,141) 59,463 Trade names and trademarks Indefinite 19,700 — — (2,398) 17,302 Customer relationships 12 years 11,400 (2,393) (287) (992) 7,728 $ 116,500 $ (17,429) $ (287) $ (12,531) $ 86,253 Intangible asset as of December 31, 2021 included the following (in thousands): December 31, 2021 Weighted-Average Amortization Period Gross Carrying Amount Accumulated Amortization Foreign currency translation adjustment Intangible Assets, Net Patent license asset 8.71 years $ 1,000 $ (919) $ — $ 81 Exclusive license asset 4 years 3,300 (660) — 2,640 Technology 12 years 81,100 (5,668) (1,424) 74,008 Trade names and trademarks Indefinite 19,700 — (365) 19,335 Customer relationships 12 years 11,400 (799) (196) 10,405 $ 116,500 $ (8,046) $ (1,985) $ 106,469 |
Schedule of Estimated Future Amortization Expense | The estimated future amortization expense as of December 31, 2022, is as follows (in thousands): 2023 $ 9,085 2024 8,962 2025 7,927 2026 7,783 2027 7,645 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Total Lease Cost | Total lease costs for the years ended December 31, 2022, 2021, and 2020 are as follows (in thousands): December 31, 2022 2021 2020 Lease cost Operating lease cost $ 2,131 $ 2,107 $ 1,991 Short-term lease cost 80 95 95 Variable lease cost 203 191 179 Total lease cost $ 2,414 $ 2,393 $ 2,265 |
Schedule of Payments of Operating Lease Liabilities | Payments of operating lease liabilities as of December 31, 2022, are as follows (in thousands): 2023 $ 2,162 2024 2,066 2025 2,150 2026 2,239 2027 2,165 Thereafter 115 10,897 Less: imputed interest (1,780) 9,117 Less: operating lease liability, current portion (1,562) Operating lease liability, net of current portion $ 7,555 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense included in the Company’s consolidated statements of comprehensive loss is allocated as follows (in thousands): Years Ended December 31, 2022 2021 2020 Research and development $ 6,734 $ 5,980 $ 3,457 General and administrative 7,965 8,079 5,852 Sales and marketing 17,319 11,105 5,786 $ 32,018 $ 25,164 $ 15,095 |
Schedule of Common Stock Reserved for Future Issuance | The Company had shares of common stock reserved for future issuance as follows at: December 31, 2022 2021 Options outstanding under the 2014 Plan 184,104 277,505 Options and restricted stock units outstanding under the 2018 Plan 1,045,924 1,400,851 Options and restricted stock-based awards remaining under the 2018 Plan for future issuance 2,694,622 950,354 3,924,650 2,628,710 |
Schedule of Stock Option Award Valuation Assumptions | The option awards issued under the 2014 and 2018 Plans were measured based on fair value. The Company’s fair value calculations were made using the Black-Scholes option pricing model with the following assumptions: Years Ended December 31, 2022 2021 2020 Expected term (in years) — 5.46 - 6.00 6.05 Stock volatility — 63.49% 72.01% Risk-free interest rate — 0.53% - 1.16% 1.37% Dividend rate — — — |
Schedule of Stock Option Activity | The following table summarizes stock option activity under the 2014 and 2018 Plans (in thousands, except share and per share data): Number of Options Weighted-Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at December 31, 2019 2,847,101 $ 13.22 Options granted 5,000 29.03 Options exercised (767,792) 5.05 $ 25,066 (1) Options forfeited (129,066) 20.20 Outstanding at December 31, 2020 1,955,243 16.01 Options granted 46,000 58.07 Options exercised (522,495) 12.60 $ 24,455 (1) Options forfeited (50,856) 29.64 Outstanding at December 31, 2021 1,427,892 18.13 Options exercised (364,352) 15.54 $ 18,251 (1) Options forfeited (16,930) 31.80 Outstanding at December 31, 2022 1,046,610 $ 18.81 $ 45,762 (2) Options exercisable at December 31, 2022 927,595 $ 17.68 $ 41,604 (2) _____________________________________________ (1) Represents the total difference between the Company’s closing stock price at the time of exercise and the stock option exercise price, multiplied by the number of options exercised. (2) Represents the total difference between the Company’s closing stock price on the last trading day of 2022 and the stock option exercise price, multiplied by the number of in-the-money options as of December 31, 2022. The amount of intrinsic value will change based on the fair market value of the Company’s stock. |
Schedule of Restricted Shares Awards and Restricted Stock Units Activity | The following table summarizes restricted shares awards activity: Number of Restricted Shares Awards Weighted-Average Fair Value Per Share at Grant Date Outstanding at December 31, 2019 586,166 $ 23.59 Restricted shares awards granted 502,500 37.68 Restricted shares awards vested (174,890) 23.29 Restricted shares awards forfeited (96,593) 28.83 Outstanding at December 31, 2020 817,183 31.70 Restricted shares awards granted 638,936 57.90 Restricted shares awards vested (235,560) 31.19 Restricted shares awards forfeited (118,525) 40.33 Outstanding at December 31, 2021 1,102,034 46.07 Restricted shares awards granted 683,354 56.69 Restricted shares awards vested (351,946) 42.15 Restricted shares awards forfeited (112,576) 50.50 Outstanding at December 31, 2022 1,320,866 $ 52.23 The following table summarizes restricted stock units activity: Number of Restricted Stock Units Weighted-Average Fair Value Per Share at Grant Date Outstanding at December 31, 2019 248,104 $ 21.48 Restricted stock units granted 8,000 29.03 Restricted stock units vested (46,336) 14.19 Restricted stock units forfeited (2,667) 14.19 Outstanding at December 31, 2020 207,101 23.49 Restricted stock units granted 212,417 43.62 Restricted stock units vested (169,054) 19.89 Outstanding at December 31, 2021 250,464 42.99 Restricted stock units granted 201,884 38.75 Restricted stock units vested (268,930) 35.88 Outstanding at December 31, 2022 183,418 $ 48.74 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Net (Loss) Income before Income Tax, Domestic and Foreign | The components of net (loss) income before income tax expense were as follows (in thousands): Years Ended December 31, 2022 2021 2020 Domestic $ (24,466) $ (56,105) $ (54,994) Foreign (37,850) (23,180) 80 Total $ (62,316) $ (79,285) $ (54,914) |
Schedule of Components of Income Tax Expense (Benefit) | The components of the income tax expense (benefit) were as follows (in thousands): Years Ended December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State 76 211 1 Foreign 174 26 — Total current income tax expense $ 250 $ 237 $ 1 Deferred: Federal $ — $ (422) $ — State — (117) — Foreign (2,868) 1,084 — Total deferred income tax (benefit) expense $ (2,868) $ 545 $ — Total $ (2,618) $ 782 $ 1 |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between the Company’s effective tax rate and the statutory tax rate is as follows: Years Ended December 31, 2022 2021 2020 Tax at statutory federal rate 21.0 % 21.0 % 21.0 % State tax, net of federal benefit 1.0 % 3.8 % 7.0 % Excess tax benefits related to stock-based compensation 8.3 % 9.4 % 10.3 % Non-deductible stock-based compensation (1.7) % (1.4) % — % Tax rate change 1.0 % (5.2) % — % Net operating loss adjustments — % (7.9) % — % Section 382 limitation — % — % — % R&D tax credit, net of reserve 4.1 % 6.1 % (4.5) % Change in valuation allowance (19.6) % (24.5) % (36.8) % Change in fair value of contingent consideration (7.3) % — % — % Other (2.6) % (2.3) % 3.0 % Effective tax rate 4.2 % (1.0) % — % |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands) as of: December 31, 2022 2021 Deferred Tax Assets: Stock-based compensation $ 4,855 $ 5,367 Depreciation and amortization (196) 7 Lease liabilities 2,169 895 Net operating loss carryforwards 76,013 74,744 Research and development credit carryforwards 7,332 4,865 Interest expense limitation carryforwards 5,457 2,518 Other 10,209 2,895 Total deferred tax assets 105,839 91,291 Less: valuation allowance (96,751) (85,061) Total net deferred tax assets $ 9,088 $ 6,230 Deferred Tax Liabilities: ROU assets $ (1,464) $ — Intangibles (24,036) (25,447) Total deferred tax liabilities $ (25,500) $ (25,447) Net deferred tax liabilities $ (16,412) $ (19,217) |
Schedule of Unrecognized Tax Benefits Roll Forward | A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows (in thousands): Balance at December 31, 2020 $ 2,491 Additions based on tax positions related to the current year 528 Additions from business combination 1,782 Deductions for tax positions taken in prior years (1,397) Balance at December 31, 2021 3,404 Additions based on tax positions related to the current year 574 Deductions for tax positions taken due to settlement (1,603) Balance at December 31, 2022 $ 2,375 |
Acquisition (Tables)
Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Schedule of Allocation of Total Purchase Consideration | The following table presents the purchase price allocation of Contura assets acquired and liabilities assumed, based on their estimated fair values as of the February 25, 2021 acquisition date (in thousands): Purchase Price Allocation Assets Acquired Cash and cash equivalents $ 593 Accounts receivable 1,688 Inventory 988 Prepaid expenses and other current assets 115 Property and equipment 52 Other assets 108 Intangible assets 112,200 Total assets acquired 115,744 Liabilities Assumed Accounts payable 209 Accrued liabilities 820 Accrued compensation and benefits 315 Lease liability 86 Debt 122 Deferred tax liabilities 19,286 Total liabilities assumed 20,838 Net assets acquired 94,906 Purchase price consideration 204,692 Goodwill $ 109,786 |
Schedule of Intangible Assets Acquired | Identified intangible assets consist of technology, trade names and trademarks, and customer relationships. The fair value of intangible assets and the determination of their respective useful lives were made in accordance with ASC 805 and are outlined in the table below: Fair Value Useful Life Technology $ 81,100 12 years Trade names and trademarks $ 19,700 Indefinite Customer relationships $ 11,400 12 years |
Schedule of Pro Forma Information | The following unaudited pro forma financial information presents the consolidated results of operations of the Company with Contura for the years ended December 31, 2021 and 2020, as if the acquisition had occurred on January 1, 2020 instead of February 25, 2021 (in thousands, except share and per share data). Contura’s revenue and net loss for the year ended December 31, 2021 were $24.1 million and $2.8 million, respectively, of which $22.7 million in revenue and $2.2 million in net income was recognized after the February 25, 2021 acquisition date. Revenue and net income recognized after the acquisition date were recorded within the Company’s consolidated statements of comprehensive loss. The pro forma information does not necessarily reflect the results of operations that would have occurred had the entities been a single company during the respective periods. Years Ended December 31, 2021 2020 Net revenue $ 181,643 $ 122,444 Net loss $ (77,535) $ (63,183) Net loss per share, basic and diluted $ (1.79) $ (1.66) Weighted-average shares used to compute basic and diluted net loss per share 43,237,536 38,077,918 The unaudited pro forma financial information above reflects the following pro forma adjustments: • An adjustment to decrease net loss for the year ended December 31, 2021 by $4.4 million to eliminate integration and acquisition related costs incurred by the Company and Contura and a corresponding increase to net loss for the year ended December 31, 2020 by $4.4 million to give effect to the integration and acquisition of Contura as if it had occurred on January 1, 2020. • An adjustment to increase net loss for the year ended December 31, 2021 by $1.3 million and a corresponding increase to net loss for the year ended December 31, 2020 by $7.8 million to reflect amortization of the fair value adjustments for intangible assets as if the assets were acquired January 1, 2020. |
Nature of Operations and Summ_4
Nature of Operations and Summary of Significant Accounting Policies - Narrative (Details) | 12 Months Ended | |||||||||
Aug. 05, 2022 USD ($) $ / shares shares | May 14, 2021 USD ($) $ / shares shares | Mar. 02, 2021 USD ($) shares | Feb. 25, 2021 USD ($) shares | May 12, 2020 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | Dec. 31, 2013 USD ($) shares | Jun. 30, 2021 USD ($) | |
Revenue Recognition: | ||||||||||
Allowance for product returns | $ 200,000 | $ 200,000 | ||||||||
Replacement costs | 200,000 | 200,000 | $ 100,000 | |||||||
Warranty liability | 100,000 | 100,000 | ||||||||
Investment Securities: | ||||||||||
Unrealized gain (loss) on investment securities | 0 | 0 | 0 | |||||||
Outstanding investment securities | 118,365,000 | 0 | ||||||||
Inventory: | ||||||||||
Finished goods inventory | 30,400,000 | 46,800,000 | ||||||||
Work-in-process inventory | 5,700,000 | 2,800,000 | ||||||||
Raw materials inventory | 19,700,000 | 15,300,000 | ||||||||
Inventory reserves | 500,000 | 200,000 | ||||||||
Goodwill: | ||||||||||
Impairment charges related to goodwill | 0 | |||||||||
Intangible Asset: | ||||||||||
Fair value of shares issued for purchase of intangible asset | 3,637,000 | |||||||||
Impairment of intangible asset | $ 287,000 | |||||||||
Impairment of intangible asset [Extensible Enumeration] | General and administrative | |||||||||
Impairment of Long-Lived Assets: | ||||||||||
Impairment of long-lived assets | $ 300,000 | |||||||||
Impairment of long-lived assets [Extensible Enumeration] | General and administrative | |||||||||
Impairment of indefinite-lived intangible assets | $ 0 | |||||||||
Advertising Expense: | ||||||||||
Advertising expense | $ 20,600,000 | $ 7,800,000 | $ 2,900,000 | |||||||
Net Loss per Share of Common Stock: | ||||||||||
Potentially dilutive weighted-average shares not included in computation of diluted weighted-average shares (shares) | shares | 2,328,525 | 2,444,444 | 2,300,982 | |||||||
Segment Reporting [Abstract] | ||||||||||
Number of operating segments | segment | 1 | |||||||||
Revenue Benchmark | Geographic Concentration Risk | United States | ||||||||||
Segment Reporting [Abstract] | ||||||||||
Concentration risk, percentage | 90% | |||||||||
Restricted Stock Units | ||||||||||
Stock-Based Compensation: | ||||||||||
Vesting period | 1 year | |||||||||
Patent license asset | ||||||||||
Intangible Asset: | ||||||||||
Finite-lived intangible asset acquired | $ 1,000,000 | |||||||||
Finite-lived intangible assets, weighted-average amortization period | 8 years 8 months 15 days | |||||||||
Impairment of intangible asset | $ 0 | |||||||||
Exclusive license asset | ||||||||||
Intangible Asset: | ||||||||||
Finite-lived intangible asset acquired | $ 3,300,000 | |||||||||
Finite-lived intangible assets, weighted-average amortization period | 4 years | |||||||||
Vendor credit in accounts payable | $ 300,000 | |||||||||
Impairment of intangible asset | $ 0 | |||||||||
Customer relationships | ||||||||||
Intangible Asset: | ||||||||||
Impairment of intangible asset | $ 287,000 | |||||||||
Preferred Stock | Patent license asset | ||||||||||
Intangible Asset: | ||||||||||
Stock issued for purchase of intangible asset (shares) | shares | 50,000 | |||||||||
Fair value of shares issued for purchase of intangible asset | $ 1,000,000 | |||||||||
Common Stock | ||||||||||
Intangible Asset: | ||||||||||
Stock issued for purchase of intangible asset (shares) | shares | 65,594 | |||||||||
Common Stock | Exclusive license asset | ||||||||||
Intangible Asset: | ||||||||||
Stock issued for purchase of intangible asset (shares) | shares | 65,594 | |||||||||
Fair value of shares issued for purchase of intangible asset | $ 3,600,000 | |||||||||
Minimum | ||||||||||
Inventory: | ||||||||||
Inventory shelf life | 12 months | |||||||||
Property and Equipment: | ||||||||||
Property and equipment useful life | 3 years | |||||||||
Stock-Based Compensation: | ||||||||||
Requisite service period of recognition of compensation cost | 3 years | |||||||||
Minimum | Stock Option and Restricted Stock-Based Awards | ||||||||||
Stock-Based Compensation: | ||||||||||
Vesting period | 3 years | |||||||||
Maximum | ||||||||||
Inventory: | ||||||||||
Inventory shelf life | 36 months | |||||||||
Property and Equipment: | ||||||||||
Property and equipment useful life | 7 years | |||||||||
Stock-Based Compensation: | ||||||||||
Requisite service period of recognition of compensation cost | 4 years | |||||||||
Maximum | Stock Option and Restricted Stock-Based Awards | ||||||||||
Stock-Based Compensation: | ||||||||||
Vesting period | 4 years | |||||||||
Contura | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Cash consideration transferred | $ 141,300,000 | |||||||||
Stock transferred in acquisition (shares) | shares | 1,096,583 | |||||||||
Maximum contingent consideration | $ 35,000,000 | |||||||||
Contingent consideration, term | 12 months | |||||||||
Amount of sales to achieve for maximum contingent consideration | $ 50,000,000 | |||||||||
Contingent consideration, milestone met payment term after quarter | 50 days | |||||||||
Contingent consideration at fair value | $ 7,600,000 | |||||||||
Intangible Asset: | ||||||||||
Finite-lived intangible assets, weighted-average amortization period | 12 years | |||||||||
Contura | Price Volatility | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration, liability, measurement input | 0.245 | |||||||||
Contura | Customer relationships | ||||||||||
Intangible Asset: | ||||||||||
Finite-lived intangible assets, weighted-average amortization period | 12 years | |||||||||
Impairment of intangible asset | $ 300,000 | |||||||||
Contura | Minimum | Measurement Input, Discount Rate | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration, liability, measurement input | 0.085 | |||||||||
Contura | Minimum | Risk Free Interest Rate | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration, liability, measurement input | 0.043 | |||||||||
Contura | Maximum | Measurement Input, Discount Rate | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration, liability, measurement input | 0.090 | |||||||||
Contura | Maximum | Risk Free Interest Rate | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration, liability, measurement input | 0.048 | |||||||||
Contura | Contingent Consideration Liability | ||||||||||
Fair Value of Financial Instruments | ||||||||||
Contingent consideration at fair value | $ 6,800,000 | $ 32,600,000 | $ 10,400,000 | $ 7,600,000 | ||||||
Follow-on Offering | ||||||||||
Follow-On Offering: | ||||||||||
Stock issued (shares) | shares | 2,012,500 | 4,025,000 | 4,600,000 | |||||||
Sale of stock, stock price (USD per share) | $ / shares | $ 63.85 | $ 50 | $ 32.50 | |||||||
Net proceeds from sale of stock | $ 128,300,000 | $ 190,000,000 | $ 140,500,000 | |||||||
Exercise of Underwriters Option | ||||||||||
Follow-On Offering: | ||||||||||
Stock issued (shares) | shares | 262,500 | 525,000 | 600,000 |
Nature of Operations and Summ_5
Nature of Operations and Summary of Significant Accounting Policies - Schedule of Revenue Disaggregated by Geographic Market (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||
Net revenue | $ 273,702 | $ 180,290 | $ 111,535 |
SNM net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 221,991 | 157,590 | 111,535 |
Bulkamid net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 51,711 | 22,700 | 0 |
United States | SNM net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 216,861 | 153,837 | 107,542 |
United States | Bulkamid net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 40,178 | 12,660 | 0 |
International markets | SNM net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | 5,130 | 3,753 | 3,993 |
International markets | Bulkamid net revenue | |||
Disaggregation of Revenue [Line Items] | |||
Net revenue | $ 11,533 | $ 10,040 | $ 0 |
Nature of Operations and Summ_6
Nature of Operations and Summary of Significant Accounting Policies - Schedule of Changes in Allowance for Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |||
Balance at beginning of period | $ 355 | $ 465 | $ 75 |
Write-offs | (75) | (12) | 0 |
Bad debt expense (recoveries) | 41 | (98) | 390 |
Balance at end of period | $ 321 | $ 355 | $ 465 |
Nature of Operations and Summ_7
Nature of Operations and Summary of Significant Accounting Policies - Schedule of Changes in Fair Value of Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Contingent consideration: | |||
Change in fair value included in earnings | $ 22,230 | $ 2,740 | $ 0 |
Level 3 | Contingent Consideration Liability | Fair Value, Recurring | |||
Contingent consideration: | |||
Balance at beginning of period | 10,370 | 0 | |
February 25, 2021 Acquisition | 7,630 | ||
Change in fair value included in earnings | 22,230 | 2,740 | |
Balance at end of period | $ 32,600 | $ 10,370 | $ 0 |
Nature of Operations and Summ_8
Nature of Operations and Summary of Significant Accounting Policies - Schedule of Fair Value Hierarchy for Assets Measured on Recurring Basis (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | $ 118,365,000 | $ 0 |
Commercial paper included in cash and cash equivalents | 131,100,000 | |
U.S. government and agency securities included in cash and cash equivalents | 4,000,000 | |
Corporate notes included in cash and cash equivalents | 2,000,000 | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 44,473,000 | |
Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 2,662,000 | |
U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 71,230,000 | |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 255,435,000 | |
Fair Value, Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 175,548,000 | |
Fair Value, Recurring | Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 4,675,000 | |
Fair Value, Recurring | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 75,212,000 | |
Fair Value, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 75,212,000 | |
Fair Value, Recurring | Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 1 | Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 1 | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 75,212,000 | |
Fair Value, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 180,223,000 | |
Fair Value, Recurring | Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 175,548,000 | |
Fair Value, Recurring | Level 2 | Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 4,675,000 | |
Fair Value, Recurring | Level 2 | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 3 | Corporate notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | 0 | |
Fair Value, Recurring | Level 3 | U.S. government and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Fair value | $ 0 |
Nature of Operations and Summ_9
Nature of Operations and Summary of Significant Accounting Policies - Schedule of Available-for-sale Debt Securities By Significant Investment Category (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-Sale [Line Items] | ||
Cost | $ 137,070,000 | |
Fair value | 137,070,000 | |
Cost | 118,479,000 | |
Unrealized gains | 6,000 | |
Unrealized losses | (120,000) | |
Fair value | 118,365,000 | $ 0 |
Cash and cash equivalents and short term investment, amortized cost | 255,549,000 | |
Cash and cash equivalents and short term investments, fair value | 255,435,000 | |
Commercial paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Cost | 131,075,000 | |
Fair value | 131,075,000 | |
Cost | 44,473,000 | |
Unrealized gains | 0 | |
Unrealized losses | 0 | |
Fair value | 44,473,000 | |
Corporate notes | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Cost | 2,013,000 | |
Fair value | 2,013,000 | |
Cost | 2,664,000 | |
Unrealized gains | 0 | |
Unrealized losses | (2,000) | |
Fair value | 2,662,000 | |
U.S. government and agency securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Cost | 3,982,000 | |
Fair value | 3,982,000 | |
Cost | 71,342,000 | |
Unrealized gains | 6,000 | |
Unrealized losses | (118,000) | |
Fair value | $ 71,230,000 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 14,334 | $ 12,459 |
Less: accumulated depreciation and amortization | (7,536) | (5,544) |
Property and equipment, net | 6,798 | 6,915 |
Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,645 | 2,429 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,282 | 2,450 |
Tools and molds | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,735 | 1,579 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,449 | 4,372 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,810 | 1,502 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 413 | $ 127 |
Property and Equipment, Net - N
Property and Equipment, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 11,721 | $ 9,126 | $ 1,741 |
Property and Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 2,300 | $ 1,900 | $ 1,600 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Schedule of Carrying Amount of Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill [Roll Forward] | ||
Balance at beginning of period | $ 105,510 | $ 0 |
February 25, 2021 Acquisition | 109,786 | |
Foreign currency translation adjustment | (11,096) | (4,276) |
Balance at end of period | $ 94,414 | $ 105,510 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of Finite-Lived and Indefinite-Lived Intangible Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets, Net: | ||
Accumulated Amortization | $ (17,429,000) | $ (8,046,000) |
Impairment | (287,000) | |
Intangible Assets, Net (Excluding Goodwill): | ||
Gross Carrying Amount | 116,500,000 | 116,500,000 |
Accumulated Amortization | (17,429,000) | (8,046,000) |
Foreign currency translation adjustment | (12,531,000) | (1,985,000) |
Intangible Assets, Net | 86,253,000 | 106,469,000 |
Trade names and trademarks | ||
Indefinite-lived Intangible Assets: | ||
Gross Carrying Amount | 19,700,000 | 19,700,000 |
Foreign currency translation adjustment | (2,398,000) | (365,000) |
Intangible Assets, Net | $ 17,302,000 | $ 19,335,000 |
Patent license asset | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period | 8 years 8 months 15 days | 8 years 8 months 15 days |
Finite-Lived Intangible Assets, Net: | ||
Gross Carrying Amount | $ 1,000,000 | $ 1,000,000 |
Accumulated Amortization | (1,000,000) | (919,000) |
Impairment | 0 | |
Foreign currency translation adjustment | 0 | 0 |
Intangible Assets, Net | 0 | 81,000 |
Intangible Assets, Net (Excluding Goodwill): | ||
Accumulated Amortization | $ (1,000,000) | $ (919,000) |
Exclusive license asset | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period | 4 years | 4 years |
Finite-Lived Intangible Assets, Net: | ||
Gross Carrying Amount | $ 3,300,000 | $ 3,300,000 |
Accumulated Amortization | (1,540,000) | (660,000) |
Impairment | 0 | |
Foreign currency translation adjustment | 0 | 0 |
Intangible Assets, Net | 1,760,000 | 2,640,000 |
Intangible Assets, Net (Excluding Goodwill): | ||
Accumulated Amortization | $ (1,540,000) | $ (660,000) |
Technology | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period | 12 years | 12 years |
Finite-Lived Intangible Assets, Net: | ||
Gross Carrying Amount | $ 81,100,000 | $ 81,100,000 |
Accumulated Amortization | (12,496,000) | (5,668,000) |
Impairment | 0 | |
Foreign currency translation adjustment | (9,141,000) | (1,424,000) |
Intangible Assets, Net | 59,463,000 | 74,008,000 |
Intangible Assets, Net (Excluding Goodwill): | ||
Accumulated Amortization | $ (12,496,000) | $ (5,668,000) |
Customer relationships | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted-Average Amortization Period | 12 years | 12 years |
Finite-Lived Intangible Assets, Net: | ||
Gross Carrying Amount | $ 11,400,000 | $ 11,400,000 |
Accumulated Amortization | (2,393,000) | (799,000) |
Impairment | (287,000) | |
Foreign currency translation adjustment | (992,000) | (196,000) |
Intangible Assets, Net | 7,728,000 | 10,405,000 |
Intangible Assets, Net (Excluding Goodwill): | ||
Accumulated Amortization | $ (2,393,000) | $ (799,000) |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization of intangible assets | $ 9,383 | $ 7,241 | $ 115 |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets - Estimated Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |
2023 | $ 9,085 |
2024 | 8,962 |
2025 | 7,927 |
2026 | 7,783 |
2027 | $ 7,645 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) | 12 Months Ended | |||||||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2022 ft² | Aug. 31, 2020 ft² | Jun. 30, 2019 ft² | Aug. 01, 2018 ft² | Aug. 31, 2014 ft² | |
Loss Contingencies [Line Items] | ||||||||
Right-of-use assets obtained in exchange for operating lease liabilities | $ 100,000 | $ 1,000,000 | $ 3,800,000 | |||||
Right-of-use asset | $ 6,200,000 | $ 7,100,000 | ||||||
Right-of-use asset [Extensible List] | Other assets | Other assets | ||||||
Cash paid for operating lease liabilities | $ 2,100,000 | $ 2,000,000 | 1,500,000 | |||||
Amortization of the ROU asset | $ 1,000,000 | $ 1,000,000 | 900,000 | |||||
Weighted-average remaining lease term for operating leases | 4 years 10 months 24 days | 5 years 10 months 24 days | ||||||
Weighted-average incremental borrowing rate, operating leases’ future payments (as a percent) | 7.10% | 7.10% | ||||||
Period after first sale royalty is due | 12 years | |||||||
Net revenue due as royalty (as a percent) | 4% | |||||||
Royalty expense | $ 3,300,000 | $ 6,300,000 | $ 4,400,000 | |||||
Accrued royalty expense | 600,000 | $ 1,800,000 | ||||||
Maximum | ||||||||
Loss Contingencies [Line Items] | ||||||||
Royalty commitments | $ 200,000 | |||||||
First Lease | ||||||||
Loss Contingencies [Line Items] | ||||||||
Term of operating lease contract | 5 years | |||||||
Net rentable area (square feet) | ft² | 12,215 | |||||||
Second Lease | ||||||||
Loss Contingencies [Line Items] | ||||||||
Net rentable area (square feet) | ft² | 25,548 | |||||||
Renewal term of operating lease | 5 years | |||||||
Third Lease | ||||||||
Loss Contingencies [Line Items] | ||||||||
Term of operating lease contract | 8 years | |||||||
Net rentable area (square feet) | ft² | 32,621 | |||||||
Renewal term of operating lease | 5 years | |||||||
Fourth Lease | ||||||||
Loss Contingencies [Line Items] | ||||||||
Term of operating lease contract | 38 months | |||||||
Net rentable area (square feet) | ft² | 5,693 | |||||||
Fifth Lease | ||||||||
Loss Contingencies [Line Items] | ||||||||
Term of operating lease contract | 18 months | |||||||
Net rentable area (square feet) | ft² | 3,276 |
Commitments and Contingencies_2
Commitments and Contingencies - Total Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Operating lease cost | $ 2,131 | $ 2,107 | $ 1,991 |
Short-term lease cost | 80 | 95 | 95 |
Variable lease cost | 203 | 191 | 179 |
Total lease cost | $ 2,414 | $ 2,393 | $ 2,265 |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Lease Payments for Operating Lease (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2023 | $ 2,162 | |
2024 | 2,066 | |
2025 | 2,150 | |
2026 | 2,239 | |
2027 | 2,165 | |
Thereafter | 115 | |
Total lease payments | 10,897 | |
Less: imputed interest | (1,780) | |
Operating lease liability | 9,117 | |
Less: operating lease liability, current portion | (1,562) | $ (1,366) |
Operating lease liability, net of current portion | $ 7,555 | $ 9,052 |
Long-Term Debt (Details)
Long-Term Debt (Details) - Term Loan - USD ($) | 1 Months Ended | ||
Jun. 30, 2021 | Jan. 31, 2021 | Feb. 28, 2021 | |
Term Loan One | |||
Debt Instrument [Line Items] | |||
Interest expense | $ 400,000 | ||
Unamortized debt issuance costs | $ 400,000 | ||
Loan and Security Agreement | |||
Debt Instrument [Line Items] | |||
Face amount of debt instrument | $ 75,000,000 | ||
Term Loan Two | |||
Debt Instrument [Line Items] | |||
Interest expense | $ 4,400,000 | ||
Unamortized debt issuance costs | $ 4,400,000 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Narrative (Details) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Equity [Abstract] | ||
Preferred stock authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock issued (shares) | 0 | 0 |
Preferred stock outstanding (shares) | 0 | 0 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Narrative (Details) | Dec. 31, 2022 vote |
Common Stock | |
Class of Stock [Line Items] | |
Number of votes per share | 1 |
Stockholders' Equity - Stock-ba
Stockholders' Equity - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 32,018 | $ 25,164 | $ 15,095 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 6,734 | 5,980 | 3,457 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 7,965 | 8,079 | 5,852 |
Sales and marketing | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 17,319 | $ 11,105 | $ 5,786 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Option Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted (shares) | 0 | 46,000 | 5,000 |
Options grants in period, weighted average grant date fair value (USD per share) | $ 32.93 | $ 18.56 | |
Options outstanding weighted average remaining contractual term | 6 years 1 month 6 days | 6 years 10 months 24 days | |
Stock Option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation cost | $ 1.8 | $ 6.7 | |
Weighted-average period of recognition of compensation cost | 1 year | 1 year 7 months 6 days | |
2014 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options and restricted stock-based awards remaining for future issuance (shares) | 0 | 0 | |
2018 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options and restricted stock-based awards remaining for future issuance (shares) | 2,694,622 | 950,354 | |
Stock reserved for issuance (shares) | 7,088,581 |
Stockholders' Equity - Common_2
Stockholders' Equity - Common Stock Reserved for Future Issuance (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options and restricted stock units outstanding (shares) | 1,046,610 | 1,427,892 | 1,955,243 | 2,847,101 |
Common stock reserved for future issuance (shares) | 3,924,650 | 2,628,710 | ||
2014 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options and restricted stock-based awards remaining for future issuance (shares) | 0 | 0 | ||
2018 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options and restricted stock-based awards remaining for future issuance (shares) | 2,694,622 | 950,354 | ||
Stock Option | 2014 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options and restricted stock units outstanding (shares) | 184,104 | 277,505 | ||
Stock Option and Restricted Stock-Based Awards | 2018 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options and restricted stock units outstanding (shares) | 1,045,924 | 1,400,851 | ||
Options and restricted stock-based awards remaining for future issuance (shares) | 2,694,622 | 950,354 |
Stockholders' Equity - Fair Val
Stockholders' Equity - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 18 days | |
Stock volatility (as a percent) | 63.49% | 72.01% |
Risk-free interest rate, minimum (as a percent) | 0.53% | |
Risk-free interest rate, maximum (as a percent) | 1.16% | |
Risk-free interest rate (as a percent) | 1.37% | |
Dividend rate (as a percent) | 0% | 0% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 5 months 15 days | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years |
Stockholders' Equity - Stock _2
Stockholders' Equity - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Options | |||
Outstanding at beginning of period (shares) | 1,427,892 | 1,955,243 | 2,847,101 |
Options granted (shares) | 0 | 46,000 | 5,000 |
Options exercised (shares) | (364,352) | (522,495) | (767,792) |
Options forfeited (shares) | (16,930) | (50,856) | (129,066) |
Outstanding at end of period (shares) | 1,046,610 | 1,427,892 | 1,955,243 |
Options exercisable (shares) | 927,595 | ||
Weighted-Average Exercise Price Per Share | |||
Outstanding at beginning of period (USD per share) | $ 18.13 | $ 16.01 | $ 13.22 |
Options granted (USD per share) | 58.07 | 29.03 | |
Options exercised (USD per share) | 15.54 | 12.60 | 5.05 |
Options forfeited (USD per share) | 31.80 | 29.64 | 20.20 |
Outstanding at end of period (USD per share) | 18.81 | $ 18.13 | $ 16.01 |
Options exercisable (USD per share) | $ 17.68 | ||
Aggregate Intrinsic Value | |||
Intrinsic value of options exercised | $ 18,251 | $ 24,455 | $ 25,066 |
Intrinsic value of options outstanding | 45,762 | ||
Intrinsic value of options exercisable | $ 41,604 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Shares Award Narrative (Details) - Restricted Shares Awards - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost | $ 54 | $ 42.5 |
Weighted-average period of recognition of compensation cost | 2 years 3 months 18 days | 3 years |
Stockholders' Equity - Restri_2
Stockholders' Equity - Restricted Shares Awards Activity (Details) - Restricted Shares Awards - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Restricted Shares Awards | |||
Outstanding at beginning of period (shares) | 1,102,034 | 817,183 | 586,166 |
Restricted shares awards granted (shares) | 683,354 | 638,936 | 502,500 |
Restricted shares awards vested (shares) | (351,946) | (235,560) | (174,890) |
Restricted shares awards forfeited (shares) | (112,576) | (118,525) | (96,593) |
Outstanding at end of period (shares) | 1,320,866 | 1,102,034 | 817,183 |
Weighted-Average Fair Value Per Share at Grant Date | |||
Outstanding at beginning of period (USD per share) | $ 46.07 | $ 31.70 | $ 23.59 |
Restricted shares awards granted (USD per share) | 56.69 | 57.90 | 37.68 |
Restricted shares awards vested (USD per share) | 42.15 | 31.19 | 23.29 |
Restricted shares awards forfeited (USD per share) | 50.50 | 40.33 | 28.83 |
Outstanding at end of period (USD per share) | $ 52.23 | $ 46.07 | $ 31.70 |
Stockholders' Equity - Restri_3
Stockholders' Equity - Restricted Stock Units Narrative (Details) - Restricted Stock Units - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost | $ 1.3 | $ 1.9 |
Weighted-average period of recognition of compensation cost | 9 months 18 days | 10 months 24 days |
Stockholders' Equity - Restri_4
Stockholders' Equity - Restricted Stock Units Activity (Details) - Restricted Stock Units - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Restricted Stock Units | |||
Outstanding at beginning of period (shares) | 250,464 | 207,101 | 248,104 |
Restricted stock units granted (shares) | 201,884 | 212,417 | 8,000 |
Restricted stock units vested (shares) | (268,930) | (169,054) | (46,336) |
Restricted stock units forfeited (shares) | (2,667) | ||
Outstanding at end of period (shares) | 183,418 | 250,464 | 207,101 |
Weighted-Average Fair Value Per Share at Grant Date | |||
Outstanding at beginning of period (USD per share) | $ 42.99 | $ 23.49 | $ 21.48 |
Restricted stock units granted (USD per share) | 38.75 | 43.62 | 29.03 |
Restricted stock units vested (USD per share) | 35.88 | 19.89 | 14.19 |
Restricted stock units forfeited (USD per share) | 14.19 | ||
Outstanding at end of period (USD per share) | $ 48.74 | $ 42.99 | $ 23.49 |
Income Taxes - Components of Ne
Income Taxes - Components of Net (Loss) Income Before Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (24,466) | $ (56,105) | $ (54,994) |
Foreign | (37,850) | (23,180) | 80 |
Loss before income tax (benefit) expense | $ (62,316) | $ (79,285) | $ (54,914) |
Income Taxes - Provision For Cu
Income Taxes - Provision For Current And Deferred Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 76 | 211 | 1 |
Foreign | 174 | 26 | 0 |
Total current income tax expense | 250 | 237 | 1 |
Deferred: | |||
Federal | 0 | (422) | 0 |
State | 0 | (117) | 0 |
Foreign | (2,868) | 1,084 | 0 |
Total deferred income tax (benefit) expense | (2,868) | 545 | 0 |
Income tax (benefit) expense | $ (2,618) | $ 782 | $ 1 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Tax at statutory federal rate | 21% | 21% | 21% |
State tax, net of federal benefit | 1% | 3.80% | 7% |
Excess tax benefits related to stock-based compensation | 8.30% | 9.40% | 10.30% |
Non-deductible stock-based compensation | (1.70%) | (1.40%) | 0% |
Tax rate change | 1% | (5.20%) | 0% |
Net operating loss adjustments | 0% | (7.90%) | 0% |
Section 382 limitation | 0% | 0% | 0% |
R&D tax credit, net of reserve | 4.10% | 6.10% | (4.50%) |
Change in valuation allowance | (19.60%) | (24.50%) | (36.80%) |
Change in fair value of contingent consideration | (7.30%) | 0% | 0% |
Other | (2.60%) | (2.30%) | 3% |
Effective tax rate | 4.20% | (1.00%) | 0% |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Contingency [Line Items] | |||
Effective tax rate (as a percent) | 4.20% | (1.00%) | 0% |
Increase (decrease) in valuation allowance | $ 11,700,000 | ||
Valuation allowance | 96,751,000 | $ 85,061,000 | |
Reduction in net operating loss carryforwards | $ 12,200,000 | ||
Unrecognized tax benefits | 2,375,000 | 3,404,000 | 2,491,000 |
Unrecognized tax benefits that would impact effective tax rate | 100,000 | ||
Interest or penalties to be recognized for the period | 0 | 0 | |
Unrecognized tax benefits accumulated interest and penalties | $ 400,000 | ||
Domestic Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | 270,300,000 | ||
Operating loss carryforwards, subject to expiration | 51,500,000 | ||
Foreign Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards | 9,600,000 | ||
State and Local Tax Authority | |||
Income Tax Contingency [Line Items] | |||
Operating loss carryforwards, subject to expiration | $ 254,600,000 | ||
Research Tax Credit Carryforward | |||
Income Tax Contingency [Line Items] | |||
Reduction in R&D tax credits | $ 1,500,000 |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Tax Assets: | ||
Stock-based compensation | $ 4,855 | $ 5,367 |
Depreciation and amortization | (196) | 7 |
Lease liabilities | 2,169 | 895 |
Net operating loss carryforwards | 76,013 | 74,744 |
Research and development credit carryforwards | 7,332 | 4,865 |
Interest expense limitation carryforwards | 5,457 | 2,518 |
Other | 10,209 | 2,895 |
Total deferred tax assets | 105,839 | 91,291 |
Less: valuation allowance | (96,751) | (85,061) |
Total net deferred tax assets | 9,088 | 6,230 |
Deferred Tax Liabilities: | ||
ROU assets | (1,464) | 0 |
Intangibles | (24,036) | (25,447) |
Total deferred tax liabilities | (25,500) | (25,447) |
Net deferred tax liabilities | $ (16,412) | $ (19,217) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of period | $ 3,404 | $ 2,491 |
Additions based on tax positions related to the current year | 574 | 528 |
Additions from business combination | 1,782 | |
Deductions for tax positions taken in prior years | (1,397) | |
Deductions for tax positions taken due to settlement | (1,603) | |
Balance at end of period | $ 2,375 | $ 3,404 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |||
Contributions by employer | $ 2.1 | $ 1.9 | $ 1.6 |
Acquisition - Narrative (Detail
Acquisition - Narrative (Details) - USD ($) | 3 Months Ended | 10 Months Ended | 12 Months Ended | ||||
Feb. 25, 2021 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | |
Business Acquisition [Line Items] | |||||||
Amortization of intangible assets | $ 9,383,000 | $ 7,241,000 | $ 115,000 | ||||
Goodwill | $ 105,510,000 | 94,414,000 | 105,510,000 | 0 | |||
Revenues | 273,702,000 | 180,290,000 | 111,535,000 | ||||
Net loss | (59,698,000) | (80,067,000) | $ (54,915,000) | ||||
Contura | |||||||
Business Acquisition [Line Items] | |||||||
Revenues | 24,100,000 | ||||||
Net loss | (2,800,000) | ||||||
Contura | |||||||
Business Acquisition [Line Items] | |||||||
Equity interest acquired (as a percent) | 100% | ||||||
Purchase price consideration | $ 204,692,000 | ||||||
Cash consideration transferred | 141,400,000 | ||||||
Stock consideration transferred | $ 55,700,000 | ||||||
Stock transferred in acquisition (shares) | 1,096,583 | ||||||
Maximum contingent consideration | $ 35,000,000 | ||||||
Amount of sales to achieve for maximum contingent consideration | 50,000,000 | ||||||
Contingent consideration at fair value | 7,600,000 | ||||||
Amortization of intangible assets | 8,400,000 | 6,500,000 | |||||
Balance of intangible assets acquired, net | $ 112,200,000 | 103,700,000 | 84,500,000 | 103,700,000 | |||
Finite-lived intangible assets, weighted-average amortization period | 12 years | ||||||
Goodwill | $ 109,786,000 | ||||||
Deferred tax liabilities | 19,286,000 | 19,300,000 | 19,300,000 | ||||
Acquisition-related costs | $ 4,400,000 | ||||||
Revenue of acquiree since acquisition date | 22,700,000 | ||||||
Net loss of acquiree since acquisition date | 2,200,000 | ||||||
Contura | Contingent Consideration Liability | |||||||
Business Acquisition [Line Items] | |||||||
Contingent consideration at fair value | $ 6,800,000 | $ 7,600,000 | $ 10,400,000 | $ 32,600,000 | $ 10,400,000 | ||
Increase (decrease) in goodwill | $ 800,000 |
Acquisition - Schedule of Preli
Acquisition - Schedule of Preliminary Allocation of Total Purchase Consideration (Details) - USD ($) $ in Thousands | Feb. 25, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Liabilities Assumed | ||||
Goodwill | $ 94,414 | $ 105,510 | $ 0 | |
Contura | ||||
Assets Acquired | ||||
Cash and cash equivalents | $ 593 | |||
Accounts receivable | 1,688 | |||
Inventory | 988 | |||
Prepaid expenses and other current assets | 115 | |||
Property and equipment | 52 | |||
Other assets | 108 | |||
Intangible assets | 112,200 | $ 84,500 | 103,700 | |
Total assets acquired | 115,744 | |||
Liabilities Assumed | ||||
Accounts payable | 209 | |||
Accrued liabilities | 820 | |||
Accrued compensation and benefits | 315 | |||
Lease liability | 86 | |||
Debt | 122 | |||
Deferred tax liabilities | 19,286 | $ 19,300 | ||
Total liabilities assumed | 20,838 | |||
Net assets acquired | 94,906 | |||
Purchase price consideration | 204,692 | |||
Goodwill | $ 109,786 |
Acquisition - Schedule of Intan
Acquisition - Schedule of Intangible Assets Acquired (Details) - Contura $ in Thousands | Feb. 25, 2021 USD ($) |
Business Acquisition [Line Items] | |
Useful Life | 12 years |
Trade names and trademarks | |
Business Acquisition [Line Items] | |
Fair value of indefinite-lived intangibles acquired | $ 19,700 |
Technology | |
Business Acquisition [Line Items] | |
Fair value of finite-lived intangibles acquired | $ 81,100 |
Useful Life | 12 years |
Customer relationships | |
Business Acquisition [Line Items] | |
Fair value of finite-lived intangibles acquired | $ 11,400 |
Useful Life | 12 years |
Acquisition - Schedule of Pro F
Acquisition - Schedule of Pro Forma Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Business Acquisition, Pro Forma Information [Abstract] | ||
Net loss per share, basic (USD per share) | $ (1.79) | $ (1.66) |
Net loss per share, diluted (USD per share) | $ (1.79) | $ (1.66) |
Weighted-average shares used to compute basic net loss per share (shares) | 43,237,536 | 38,077,918 |
Weighted-average shares used to compute diluted net loss per share (shares) | 43,237,536 | 38,077,918 |
Contura | ||
Business Acquisition, Pro Forma Information [Abstract] | ||
Net revenue | $ 181,643 | $ 122,444 |
Net loss | (77,535) | (63,183) |
Contura | Acquisition-related costs | ||
Business Acquisition, Pro Forma Information [Abstract] | ||
Net loss | 4,400 | (4,400) |
Contura | Fair value adjustment to intangible assets | ||
Business Acquisition, Pro Forma Information [Abstract] | ||
Net loss | $ (1,300) | (7,800) |
Contura | Fair value adjustment for deferred tax liabilities | ||
Business Acquisition, Pro Forma Information [Abstract] | ||
Net loss | $ 2,200 |