0001603756-22-000076 | 10-Q | XBRL Viewer

Goodwill and Intangible Assets - Schedule of Finite-Lived and Indefinite-Lived Intangible Assets (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Finite-Lived Intangible Assets, Net:
Accumulated Amortization	$ (15,157,000)	$ (8,046,000)
Impairment	(287,000)
Intangible Assets, Net (Excluding Goodwill):
Gross Carrying Amount	116,500,000	116,500,000
Accumulated Amortization	(15,157,000)	(8,046,000)
Foreign currency translation adjustment	(19,269,000)	(1,985,000)
Intangible assets, net	81,787,000	106,469,000
Trade names and trademarks
Indefinite-lived Intangible Assets:
Gross Carrying Amount	19,700,000	19,700,000
Foreign currency translation adjustment	(3,768,000)	(365,000)
Intangible Assets, Net	$ 15,932,000	$ 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	(1,320,000)	(660,000)
Impairment	0
Foreign currency translation adjustment	0	0
Intangible Assets, Net	1,980,000	2,640,000
Intangible Assets, Net (Excluding Goodwill):
Accumulated Amortization	$ (1,320,000)	$ (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	(10,795,000)	(5,668,000)
Impairment	0
Foreign currency translation adjustment	(13,991,000)	(1,424,000)
Intangible Assets, Net	56,314,000	74,008,000
Intangible Assets, Net (Excluding Goodwill):
Accumulated Amortization	$ (10,795,000)	$ (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	(2,042,000)	(799,000)
Impairment	(287,000)
Foreign currency translation adjustment	(1,510,000)	(196,000)
Intangible Assets, Net	7,561,000	10,405,000
Intangible Assets, Net (Excluding Goodwill):
Accumulated Amortization	$ (2,042,000)	$ (799,000)

Property and Equipment, Net - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Property, Plant and Equipment [Line Items]
Depreciation and amortization expense			$ 8,841	$ 6,483
Property and Equipment
Property, Plant and Equipment [Line Items]
Depreciation and amortization expense	$ 600	$ 500	$ 1,700	$ 1,400

Employee Benefit Plan (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
Employee Benefit Plan (Details) - USD ($) $ in Millions	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Retirement Benefits [Abstract]
Contributions by employer	$ 0.5	$ 0.4	$ 1.5	$ 1.4

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Allowance for doubtful accounts	$ 298	$ 355
Preferred stock, par value (in USD per share)	$ 0.0001	$ 0.0001
Preferred stock authorized (in shares)	10,000,000	10,000,000
Preferred stock issued (in shares)	0	0
Preferred stock outstanding (in shares)	0	0
Common stock, par value (in USD per share)	$ 0.0001	$ 0.0001
Common stock authorized (in shares)	75,000,000	50,000,000
Common stock issued (in shares)	49,479,594	46,330,167
Common stock outstanding (in shares)	49,479,594	46,330,167

Income Taxes (Tables)

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

Schedule of Provision for Income Taxes and Effective Tax Rates

The following table presents details of the provision for income taxes and effective tax rates (in thousands, except percentages):


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022	2021	2022	2021
Income tax (benefit) expense	$(520)	$528	$(2,096)	$3,269
Effective tax rate	3.10%	3.16%	3.36%	5.30%

Income Taxes - Schedule of Provision for Income Taxes and Effective Tax Rates (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Tax Disclosure [Abstract]
Income tax (benefit) expense	$ (520)	$ 528	$ (2,096)	$ 3,269
Effective tax rate (as a percent)	3.10%	3.16%	3.36%	5.30%

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 8,218	$ 6,690	$ 23,261	$ 18,320
Research and development
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	1,734	1,549	4,996	4,435
General and administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	2,052	2,158	5,980	5,930
Sales and marketing
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 4,432	$ 2,983	$ 12,285	$ 7,955

Nature of Operations and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Principles of Consolidation	Principles of Consolidation The accompanying unaudited interim condensed 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 and Liquidity	Basis of Presentation and Liquidity Interim Financial Statements The unaudited interim condensed consolidated financial statements and related footnote disclosures as of and for the three and nine months ended September 30, 2022 are unaudited, and are not necessarily indicative of the Company’s operating results for a full year. The unaudited interim condensed consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial results for the three and nine months ended September 30, 2022 in accordance with United States generally accepted accounting principles (GAAP), however, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (SEC) rules and regulations relating to interim financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included within the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (filed with the SEC on March 1, 2022).
Reclassifications	Reclassifications Certain prior period reported amounts have been reclassified to conform with the current period presentation.
Use of Estimates	Use of Estimates The preparation of unaudited condensed 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 Recognition Revenue recognized during the nine months ended September 30, 2022 and 2021 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 expects to receive 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 September 30, 2022 and December 31, 2021, respectively, and is recorded as a reduction of gross revenue in its unaudited condensed consolidated statements of comprehensive loss. Damaged or defective products are replaced at no charge under the Company’s standard warranty. For the three and nine months ended September 30, 2022, the replacement costs were minimal and $0.1 million, respectively. For the three and nine months ended September 30, 2021, the replacement costs were minimal and $0.2 million, respectively. The replacement costs are recorded within the sales and marketing expenses in its unaudited condensed 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 September 30, 2022 and December 31, 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 Accounting Standards Update (ASU) 2016-13. 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. 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 unaudited condensed consolidated financial statements approximate the fair value for cash and cash equivalents, short-term investments, 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, we acquired Contura Limited and its Bulkamid product, a urethral bulking agent indicated for the treatment of female SUI. In consideration for the acquisition, we paid approximately $141.3 million in cash and issued 1,096,583 shares of our common stock. We 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.
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 date of purchase are considered short-term investments. Those investments in debt securities with maturities greater than 12 months at the date of purchase 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 unaudited condensed consolidated statements of comprehensive loss. There were no unrealized gains or losses during the three and nine months ended September 30, 2022 and 2021. 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 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 September 30, 2022 and December 31, 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 September 30, 2022 and December 31, 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 r-SNM System 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.
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 and seven years. Leasehold improvements are amortized over the lesser of the life of the lease or the useful life of the improvements. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations.
Goodwill	Goodwill Goodwill represents the excess purchase price over the fair values of the identifiable 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.
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 initial public offering, 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 amortization of this intangible asset was $0.1 million during the nine months ended September 30, 2022 and 2021. The amortization of the patent license asset was minimal during the three months ended September 30, 2022 and 2021. 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 8. 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, $0.0001 par value, 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 unaudited condensed consolidated balance sheets. Amortization of this asset is recorded over the four-year term of the agreement on a straight-line basis. The Company recorded expense for the amortization of the exclusive license asset of $0.3 million and $0.7 million during the three and nine months ended September 30, 2022, respectively. There was $0.2 million and $0.4 million of amortization of this intangible asset recorded during the three and nine months ended September 30, 2021, respectively. 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 8. Contura acquisition The intangible assets represent technology, trade names and trademarks, and customer relationships acquired from Contura on February 25, 2021. The straight-line method over the period of estimated benefit is used to amortize finite-lived intangible assets except for customer relationships. Accounting Standards Codification (ASC) 350-30-35-3 states that customer relationships generally dissipate at a more rapid rate in the earlier periods following a company’s succession to these relationships, with the rate of attrition declining over time. As such, the accelerated method is used to amortize customer relationships. The Company recorded expense for the amortization of Contura acquisition intangible assets of $2.1 million and $6.4 million during the three and nine months ended September 30, 2022, respectively. There was $2.0 million and $4.6 million of amortization of these intangible assets recorded during the three and nine months ended September 30, 2021, respectively. The Company reviewed the intangible assets for impairment for this asset group during the three months ended September 30, 2022. As Bulkamid SARL ceased sales operations and did not recognize revenue during the three months ended September 30, 2022, and does not expect to recognize revenue in future periods, the Company wrote off the customer relationships intangible asset of $0.3 million related to this entity. The impairment expense is recorded within the general and administrative expenses in its unaudited condensed consolidated statements of comprehensive loss. For additional information, see Note 8.
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 during the three and nine months ended September 30, 2022. 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 three and nine months ended September 30, 2022.
Leases	Leases In accordance with 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) asset 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 asset 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, 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 or four years. 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 actually become exercisable. The Company uses the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. Stock options and restricted shares awards vest based on service conditions, typically over three or four years. The Company also grants shares of performance-based restricted stock units that typically vest after one year only if the Company has also achieved certain performance objectives as defined and approved by the Company’s board of directors. The fair value of performance awards are determined based on the Company’s stock price at the date of grant and expensed over the performance period based on the probability of achieving the performance objectives. In addition, the Company also grants market-based restricted stock units that have combined market conditions and service conditions for vesting, for which the Company uses the Monte Carlo valuation model to value equity awards (as of the date of grant). Compensation cost is not adjusted if the market condition is not met, as long as the requisite service is provided.
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.

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash Flows from Operating Activities
Net loss	$ (60,363)	$ (64,901)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization	8,841	6,483
Stock-based compensation	23,261	18,320
Amortization of debt issuance costs	0	4,991
Reversal of allowance of credit losses	(57)	(92)
Change in fair value of contingent consideration	20,130	1,250
Deferred income taxes and other items, net	(1,630)	3,711
Changes in operating assets and liabilities, net of business acquisition
Accounts receivable	(8,220)	(6,669)
Inventory	6,256	(6,671)
Prepaid expenses and other current assets	1,836	1,075
Other assets	98	(273)
Accounts payable	2,517	62
Accrued liabilities	1,740	(978)
Accrued compensation and benefits	(624)	3,047
Lease liability	53	115
Net cash used in operating activities	(6,162)	(40,530)
Cash Flows from Investing Activities
Purchases of property and equipment	(1,888)	(1,177)
Purchases of short-term investments	(128,436)	0
Proceeds from sales and maturities of short-term investments	20,000	0
Acquisition of a business, net of cash acquired	0	(140,741)
Net cash used in investing activities	(110,324)	(141,918)
Cash Flows from Financing Activities
Payment of debt issuance costs	0	(106)
Proceeds from debt	0	75,000
Repayment of debt	0	(101,000)
Proceeds from offering of common stock upon follow-on public offering	128,498	201,250
Payment of common stock offering costs upon follow-on public offering	(192)	(11,272)
Proceeds from exercise of stock options	5,501	6,439
Net cash provided by financing activities	133,807	170,311
Effect of exchange rate changes on cash and cash equivalents	3,132	(247)
Net increase (decrease) in cash and cash equivalents	20,453	(12,384)
Cash and cash equivalents, beginning of year	220,878	241,181
Cash and cash equivalents, end of period	241,331	228,797
Supplemental Disclosure of Cash Flow Information
Cash paid for interest	1	2,178
Cash paid for taxes	644	1
Noncash Investing and Financing Activities
Property and equipment acquired but not yet paid	29	0
Common stock issuance for business acquisition	0	55,728
Contingent consideration for business acquisition	0	7,630
Common stock issuance for exclusive license asset	0	3,637
Accrued loan fees as debt issuance costs	$ 0	$ 4,500

Goodwill and Intangible Assets

9 Months Ended

Sep. 30, 2022

Goodwill and Intangible Assets Disclosure [Abstract]

Goodwill and Intangible Assets

The change in the carrying amount of goodwill during the nine months ended September 30, 2022 included the following (in thousands):


December 31, 2021	$	105,510

Foreign currency translation adjustment	(18,568)
September 30, 2022	$	86,942

Intangible assets as of September 30, 2022 included the following (in thousands):


		September 30, 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		(1,320)		—		—		1,980
Technology	12 years	81,100		(10,795)		—		(13,991)		56,314
Trade names and trademarks	Indefinite	19,700		—		—		(3,768)		15,932
Customer relationships	12 years	11,400		(2,042)		(287)		(1,510)		7,561
		$	116,500	$	(15,157)	$	(287)	$	(19,269)	$	81,787

Intangible assets 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 Asset, 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

Nature of Operations and Summary of Significant Accounting Policies - Schedule of Fair Value Hierarchy for Assets Measured on Recurring Basis (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments		$ 0
Commercial paper included in cash and cash equivalents	$ 143,300,000
U.S. government and agency securities included in cash and cash equivalents	4,000,000
Fair Value, Recurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	255,971,000
Fair Value, Recurring \| Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	192,797,000
Fair Value, Recurring \| U.S. government and agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	63,174,000
Fair Value, Recurring \| Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	63,174,000
Fair Value, Recurring \| Level 1 \| Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	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]
Investments	63,174,000
Fair Value, Recurring \| Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	192,797,000
Fair Value, Recurring \| Level 2 \| Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	192,797,000
Fair Value, Recurring \| Level 2 \| U.S. government and agency securities
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	0
Fair Value, Recurring \| Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	0
Fair Value, Recurring \| Level 3 \| Commercial paper
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	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]
Investments	$ 0

Commitments and Contingencies - Schedule of Total Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Operating lease cost	$ 542	$ 524	$ 1,590	$ 1,583
Short-term lease cost	24	25	65	77
Variable lease cost	91	54	164	152
Total lease cost	$ 657	$ 603	$ 1,819	$ 1,812

Stock-Based Compensation - Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands	9 Months Ended
	Sep. 30, 2022 USD ($) $ / shares shares
Number of Options
Outstanding at beginning of period (in shares) \| shares	1,427,892
Options exercised (in shares) \| shares	(347,203)
Options forfeited (in shares) \| shares	(14,249)
Outstanding at end of period (in shares) \| shares	1,066,440
Weighted-Average Exercise Price Per Share
Outstanding at beginning of period (in USD per share) \| $ / shares	$ 18.13
Options exercised (in USD per share) \| $ / shares	15.84
Options forfeited (in USD per share) \| $ / shares	33.50
Outstanding at end of period (in USD per share) \| $ / shares	$ 18.66
Aggregate Intrinsic Value
Intrinsic value of options exercised \| $	$ 17,288
Intrinsic value of options outstanding \| $	$ 55,216

Goodwill and Intangible Assets - Schedule of Carrying Amount of Goodwill (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2022 USD ($)
Goodwill [Roll Forward]
Balance at beginning of period	$ 105,510
Foreign currency translation adjustment	(18,568)
Balance at end of period	$ 86,942

- Definition

Amount after accumulated impairment loss of an asset representing future economic benefits arising from other assets acquired in a business combination that are not individually identified and separately recognized.

+ References + Details

Nature of Operations and Summary of Significant Accounting Policies - Schedule of Changes in Allowance for Doubtful Accounts (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Balance at beginning of period	$ 355	$ 465
Write-offs	(74)	(12)
Bad debt expense (recoveries)	17	(68)
Balance at end of period	$ 298	$ 385

Commitments and Contingencies - Narrative (Details)	3 Months Ended		9 Months Ended
Commitments and Contingencies - Narrative (Details)	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)	Mar. 31, 2022 ft²	Dec. 31, 2021 USD ($)	Aug. 31, 2020 ft²	Jun. 30, 2019 ft²	Nov. 30, 2017 ft²	Aug. 31, 2014 ft²
Loss Contingencies [Line Items]
Right-of-use assets obtained in exchange for operating lease liabilities	$ 100,000	$ 0	$ 100,000	$ 100,000
Right-of-use asset	6,400,000		6,400,000			$ 7,100,000
Cash paid for operating lease liabilities	600,000	500,000	1,600,000	1,500,000
Amortization of the ROU asset	$ 300,000	300,000	$ 800,000	800,000
Weighted-average remaining lease terms for operating leases	5 years 1 month 6 days		5 years 1 month 6 days			5 years 10 months 24 days
Weighted-average incremental borrowing rate for a collateralized asset of the same remaining term (as a percent)	7.10%		7.10%			7.10%
Period after first sale royalty is due			12 years
Net revenue due as royalty (as a percent)			4.00%
Royalty expense	$ 600,000	$ 1,600,000	$ 2,800,000	$ 4,500,000
Accrued royalty expense	500,000		500,000			$ 1,800,000
Maximum
Loss Contingencies [Line Items]
Royalty commitments	$ 200,000		$ 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]
Term of operating lease contract									7 years
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

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Schedule of Stock-based Compensation Expense

Stock-based compensation expense included in the Company’s unaudited condensed consolidated statements of comprehensive loss is allocated as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Research and development	$	1,734	$	1,549	$	4,996	$	4,435
General and administrative	2,052		2,158		5,980		5,930
Sales and marketing	4,432		2,983		12,285		7,955
	$	8,218	$	6,690	$	23,261	$	18,320

Schedule of Option Awards Fair Valuation Assumptions

The option awards issued under the 2014 Stock Option Plan (the 2014 Plan) and the 2018 Omnibus Incentive Plan (the 2018 Plan) 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:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022	2021	2022	2021
Expected term (in years)	—	5.50	—	5.46 - 6.00
Stock volatility	—	63.49%	—	63.49%
Risk-free interest rate	—	0.85%	—	0.53% - 1.16%
Dividend rate	—	—	—	—

Schedule of Stock Option Activity

The following table summarizes stock option activity for the nine months ended September 30, 2022 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, 2021	1,427,892	$	18.13

Options exercised	(347,203)	15.84		$	17,288	(1)
Options forfeited	(14,249)	33.50
Outstanding at September 30, 2022	1,066,440	$	18.66	$	55,216	(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 the third quarter of 2022 and the stock option exercise price, multiplied by the number of in-the-money options as of September 30, 2022. The amount of intrinsic value will change based on the fair market value of the Company’s stock.

Schedule of Restricted Shares Awards Activity

The following table summarizes restricted shares awards activity for the nine months ended September 30, 2022:


	Number of Restricted Shares Awards	Weighted-Average Fair Value Per Share at Grant Date
Outstanding at December 31, 2021	1,102,034	$	46.07
Restricted shares awards granted	611,954	54.89
Restricted shares awards vested	(271,547)	41.25
Restricted shares awards forfeited	(91,160)	51.35
Outstanding at September 30, 2022	1,351,281	$	50.68

Schedule of Restricted Stock Units Activity

The following table summarizes restricted stock units activity for the nine months ended September 30, 2022:


	Number of Restricted Stock Units	Weighted-Average Fair Value Per Share at Grant Date
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 September 30, 2022	183,418	$	48.74

Stock-Based Compensation

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Stock-Based Compensation

Stock-based compensation expense included in the Company’s unaudited condensed consolidated statements of comprehensive loss is allocated as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Research and development	$	1,734	$	1,549	$	4,996	$	4,435
General and administrative	2,052		2,158		5,980		5,930
Sales and marketing	4,432		2,983		12,285		7,955
	$	8,218	$	6,690	$	23,261	$	18,320

Stock Option Activity


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022	2021	2022	2021
Expected term (in years)	—	5.50	—	5.46 - 6.00
Stock volatility	—	63.49%	—	63.49%
Risk-free interest rate	—	0.85%	—	0.53% - 1.16%
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 three and nine months ended September 30, 2022. The weighted-average grant date fair value of options granted was $33.08 and $32.93 for the three and nine months ended September 30, 2021.

As of September 30, 2022 and December 31, 2021, there was $2.8 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 1.1 years and 1.6 years, respectively.

The following table summarizes stock option activity for the nine months ended September 30, 2022 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, 2021	1,427,892	$	18.13

Options exercised	(347,203)	15.84		$	17,288	(1)
Options forfeited	(14,249)	33.50
Outstanding at September 30, 2022	1,066,440	$	18.66	$	55,216	(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.

The weighted-average remaining contractual term of options outstanding and exercisable was 6.3 years and 6.9 years at September 30, 2022 and December 31, 2021, respectively.

Restricted Shares Awards Activity

As of September 30, 2022 and December 31, 2021, there was $56.1 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 2.5 years and 3.0 years, respectively.

The following table summarizes restricted shares awards activity for the nine months ended September 30, 2022:


	Number of Restricted Shares Awards	Weighted-Average Fair Value Per Share at Grant Date
Outstanding at December 31, 2021	1,102,034	$	46.07
Restricted shares awards granted	611,954	54.89
Restricted shares awards vested	(271,547)	41.25
Restricted shares awards forfeited	(91,160)	51.35
Outstanding at September 30, 2022	1,351,281	$	50.68

Restricted Stock Units Activity

As of September 30, 2022 and December 31, 2021, there was $2.8 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 for the nine months ended September 30, 2022:


	Number of Restricted Stock Units	Weighted-Average Fair Value Per Share at Grant Date
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 September 30, 2022	183,418	$	48.74

Stock-Based Compensation - Schedule of Option Awards Fair Valuation Assumptions (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (in years)	0 years	5 years 6 months	0 years
Stock volatility (as a percent)	0.00%	63.49%	0.00%	63.49%
Risk-free interest rate (as a percent)	0.00%	0.85%	0.00%
Risk-free interest rate, minimum (as a percent)				0.53%
Risk-free interest rate, maximum (as a percent)				1.16%
Dividend rate (as a percent)	0.00%	0.00%	0.00%	0.00%
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

Nature of Operations and Summary of Significant Accounting Policies - Schedule of Revenue Disaggregated by Geographic Market (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Disaggregation of Revenue [Line Items]
Net revenue	$ 70,384	$ 46,913	$ 187,784	$ 127,155
SNM net revenue
Disaggregation of Revenue [Line Items]
Net revenue	56,859	40,069	151,687	113,166
Bulkamid net revenue
Disaggregation of Revenue [Line Items]
Net revenue	13,525	6,844	36,097	13,989
United States \| SNM net revenue
Disaggregation of Revenue [Line Items]
Net revenue	55,610	39,147	147,793	110,135
United States \| Bulkamid net revenue
Disaggregation of Revenue [Line Items]
Net revenue	11,045	3,921	27,837	6,870
International markets \| SNM net revenue
Disaggregation of Revenue [Line Items]
Net revenue	1,249	922	3,894	3,031
International markets \| Bulkamid net revenue
Disaggregation of Revenue [Line Items]
Net revenue	$ 2,480	$ 2,923	$ 8,260	$ 7,119

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

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+ Details

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	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Contingent consideration:
Change in fair value included in earnings	$ 20,130	$ 1,250
Level 3 \| Contingent Consideration Liability \| Fair Value, Recurring
Contingent consideration:
Balance at beginning of period	10,370	0
February 25, 2021 Acquisition	0	7,630
Change in fair value included in earnings	20,130	1,250
Balance at end of period	$ 30,500	$ 8,880

Nature of Operations and Summary of Significant Accounting Policies - Narrative (Details)					3 Months Ended						9 Months Ended		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	Sep. 30, 2022 USD ($) $ / shares shares	Jun. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2021 USD ($) shares	Jun. 30, 2021 USD ($) $ / shares	Mar. 31, 2021 USD ($) shares	Sep. 30, 2022 USD ($) segment $ / shares shares	Sep. 30, 2021 USD ($) shares	Dec. 31, 2013 USD ($) shares	Dec. 31, 2021 USD ($) $ / shares	Dec. 31, 2020 USD ($)
May 2021 and August 2022 Follow-On Offering:
Sale of stock, price per share (in USD per share) \| $ / shares					$ 63.85				$ 50.00		$ 63.85
Basis of Presentation and Liquidity
Net loss					$ 16,252,000	$ 21,443,000	$ 22,668,000	$ 17,250,000	$ 25,148,000	$ 22,503,000	$ 60,363,000	$ 64,901,000
Accumulated deficit					374,929,000						374,929,000			$ 314,566,000
Cash, cash equivalents, and short-term investments					350,000,000						350,000,000
Cash and cash equivalents					241,331,000			228,797,000			241,331,000	228,797,000		220,878,000	$ 241,181,000
Outstanding borrowings					0						0
Revenue Recognition
Allowance for product returns					200,000						200,000			200,000
Replacement costs					0			0			100,000	200,000
Warranty liability					100,000						100,000			100,000
Investment Securities:
Unrealized gain (loss) on investment securities					0			0			0	0
Outstanding investment securities														0
Inventory:
Finished goods inventory					34,100,000						34,100,000			46,800,000
Work-in-process inventory					5,700,000						5,700,000			2,800,000
Raw materials inventory					18,000,000						18,000,000			15,300,000
Inventory reserves					400,000						400,000			$ 200,000
Goodwill:
Impairment charges related to goodwill											0
Intangible Asset:
Fair value of shares issued for purchase of intangible asset										$ 3,637,000
Amortization of intangible assets					$ 2,317,000			2,216,000			7,112,000	5,094,000
Impairment of intangible asset											$ 287,000
Common stock, par value (in USD per share) \| $ / shares					$ 0.0001						$ 0.0001			$ 0.0001
Impairment of Long-Lived Assets:
Impairment of long-lived assets					$ 300,000						$ 300,000
Impairment of indefinite-lived intangible assets					0						0
Advertising Expense:
Advertising expense					$ 6,000,000			$ 2,600,000			$ 15,500,000	$ 5,500,000
Net Loss per Share of Common Stock:
Potentially dilutive weighted-average shares not included in computation of diluted weighted average shares (in shares) \| shares					2,389,761			2,459,912			2,401,649	2,460,176
Segment Reporting [Abstract]
Number of operating segments \| segment											1
Revenue Benchmark \| Geographic Concentration Risk \| United States
Segment Reporting [Abstract]
Concentration risk, percentage											90.00%
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
Amortization of intangible assets					$ 0			$ 0			$ 100,000	$ 100,000
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
Amortization of intangible assets					300,000			200,000			$ 700,000	400,000
Impairment of intangible asset											0
Vendor credit in accounts payable			$ 300,000
Customer relationships
Intangible Asset:
Impairment of intangible asset											$ 287,000
Preferred Stock \| Patent license asset
Intangible Asset:
Stock issued for purchase of intangible asset (in 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 (in shares) \| shares										65,594
Common Stock \| Exclusive license asset
Intangible Asset:
Stock issued for purchase of intangible asset (in 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 (in 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
Intangible Asset:
Amortization of intangible assets					2,100,000			$ 2,000,000			$ 6,400,000	$ 4,600,000
Contura \| Customer relationships
Intangible Asset:
Impairment of intangible asset					$ 300,000
Contura \| Volatility
Fair Value of Financial Instruments
Contingent consideration, liability, measurement input					0.240						0.240
Contura \| Minimum \| Discount rate
Fair Value of Financial Instruments
Contingent consideration, liability, measurement input					0.070						0.070
Contura \| Minimum \| Risk-free rate
Fair Value of Financial Instruments
Contingent consideration, liability, measurement input					0.030						0.030
Contura \| Maximum \| Discount rate
Fair Value of Financial Instruments
Contingent consideration, liability, measurement input					0.082						0.082
Contura \| Maximum \| Risk-free rate
Fair Value of Financial Instruments
Contingent consideration, liability, measurement input					0.042						0.042
Contura \| Contingent Consideration Liability
Fair Value of Financial Instruments
Contingent consideration at fair value					$ 30,500,000						$ 30,500,000			$ 10,400,000
Follow-on Offering
May 2021 and August 2022 Follow-On Offering:
Stock issued (in shares) \| shares	2,012,500	4,025,000
Sale of stock, price per share (in USD per share) \| $ / shares	$ 63.85	$ 50.00
Net proceeds from sale of stock	$ 128,300,000	$ 190,000,000
Exercise of Underwriters Option
May 2021 and August 2022 Follow-On Offering:
Stock issued (in shares) \| shares	262,500	525,000

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Schedule of Total Lease Cost

Total lease costs for the three and nine months ended September 30, 2022 and 2021 are as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Lease cost
Operating lease cost	$	542	$	524	$	1,590	$	1,583
Short-term lease cost	24		25		65		77
Variable lease cost	91		54		164		152
Total lease cost	$	657	$	603	$	1,819	$	1,812

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 241,331	$ 220,878
Short-term investments	108,682	0
Accounts receivable, net of allowance for credit losses of $298 and $355 at September 30, 2022 and December 31, 2021, respectively	36,960	29,044
Inventory, net	57,827	64,946
Prepaid expenses and other current assets	4,561	6,449
Total current assets	449,361	321,317
Property and equipment, net	7,103	6,915
Intangible assets, net	81,787	106,469
Other assets	7,085	7,734
Goodwill	86,942	105,510
Total assets	632,278	547,945
Current liabilities
Accounts payable	9,972	7,654
Accrued liabilities	7,106	5,435
Accrued compensation and benefits	11,742	12,413
Operating lease liability, current portion	1,523	1,366
Other current liabilities	30,500	0
Total current liabilities	60,843	26,868
Operating lease liability, net of current portion	7,960	9,052
Deferred tax liabilities, net	13,957	19,217
Other long-term liabilities	0	10,370
Total liabilities	82,760	65,507
Commitments and contingencies (Note 3)
Stockholders’ equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021	0	0
Common stock, par value $0.0001, 75,000,000 and 50,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively; 49,479,594 and 46,330,167 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	5	5
Additional paid-in capital	960,627	803,559
Accumulated deficit	(374,929)	(314,566)
Accumulated other comprehensive loss	(36,185)	(6,560)
Total stockholders’ equity	549,518	482,438
Total liabilities and stockholders’ equity	$ 632,278	$ 547,945

Employee Benefit Plan	9 Months Ended
Employee Benefit Plan	Sep. 30, 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 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 three and nine months ended September 30, 2022, the Company’s contributions to the plan amounted to $0.5 million and $1.5 million, respectively. During the three and nine months ended September 30, 2021, the Company’s contributions to the plan amounted to $0.4 million and $1.4 million, respectively.

- Definition

The entire disclosure for retirement benefits.

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+ Details

Goodwill and Intangible Assets (Tables)

9 Months Ended

Sep. 30, 2022

Goodwill and Intangible Assets Disclosure [Abstract]

Schedule of Carrying Amount of Goodwill

The change in the carrying amount of goodwill during the nine months ended September 30, 2022 included the following (in thousands):


December 31, 2021	$	105,510

Foreign currency translation adjustment	(18,568)
September 30, 2022	$	86,942

Schedule of Finite-Lived and Indefinite-Lived Intangible Assets

Intangible assets as of September 30, 2022 included the following (in thousands):


		September 30, 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		(1,320)		—		—		1,980
Technology	12 years	81,100		(10,795)		—		(13,991)		56,314
Trade names and trademarks	Indefinite	19,700		—		—		(3,768)		15,932
Customer relationships	12 years	11,400		(2,042)		(287)		(1,510)		7,561
		$	116,500	$	(15,157)	$	(287)	$	(19,269)	$	81,787

Intangible assets 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 Asset, 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

- Definition

Tabular disclosure of goodwill by reportable segment and in total which includes a rollforward schedule.

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+ Details

Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 14,305	$ 12,459
Less: accumulated depreciation and amortization	(7,202)	(5,544)
Property and equipment, net	7,103	6,915
Equipment
Property, Plant and Equipment [Line Items]
Property and equipment, gross	2,576	2,429
Computer hardware and software
Property, Plant and Equipment [Line Items]
Property and equipment, gross	3,304	2,450
Tools and molds
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,841	1,579
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property and equipment, gross	4,448	4,372
Furniture and fixtures
Property, Plant and Equipment [Line Items]
Property and equipment, gross	1,837	1,502
Construction in progress
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 299	$ 127

Stock-Based Compensation - Schedule of Restricted Shares Awards Activity (Details) - Restricted Shares Awards	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of Restricted Shares Awards
Outstanding at beginning of period (in shares) \| shares	1,102,034
Restricted shares awards granted (in shares) \| shares	611,954
Restricted shares awards vested (in shares) \| shares	(271,547)
Restricted shares awards forfeited (in shares) \| shares	(91,160)
Outstanding at end of period (in shares) \| shares	1,351,281
Weighted-Average Fair Value Per Share at Grant Date
Outstanding at beginning of period (in USD per share) \| $ / shares	$ 46.07
Restricted shares awards granted (in USD per share) \| $ / shares	54.89
Restricted shares awards vested (in USD per share) \| $ / shares	41.25
Restricted shares awards forfeited (in USD per share) \| $ / shares	51.35
Outstanding at end of period (in USD per share) \| $ / shares	$ 50.68

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2022	Nov. 07, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
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 Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		49,529,971
Amendment Flag	false
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001603756
Current Fiscal Year End Date	--12-31

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Statement of Comprehensive Income [Abstract]
Net revenue	$ 70,384	$ 46,913	$ 187,784	$ 127,155
Cost of goods sold	19,124	15,719	53,086	46,828
Gross profit	51,260	31,194	134,698	80,327
Operating expenses
Research and development	7,936	8,648	26,307	27,115
General and administrative	9,389	7,443	29,974	22,104
Sales and marketing	39,751	28,112	112,195	74,451
Amortization of intangible assets	2,317	2,216	7,112	5,094
Acquisition-related costs	8,242	1,277	20,447	5,691
Total operating expenses	67,635	47,696	196,035	134,455
Loss from operations	(16,375)	(16,502)	(61,337)	(54,128)
Other income (expense)
Interest income	1,501	9	1,904	24
Interest and other expense	(1,898)	(229)	(3,026)	(7,528)
Other expense, net	(397)	(220)	(1,122)	(7,504)
Loss before income tax (benefit) expense	(16,772)	(16,722)	(62,459)	(61,632)
Income tax (benefit) expense	(520)	528	(2,096)	3,269
Net loss	(16,252)	(17,250)	(60,363)	(64,901)
Foreign currency translation adjustment	(12,057)	(5,138)	(29,625)	(6,481)
Comprehensive loss	$ (28,309)	$ (22,388)	$ (89,988)	$ (71,382)
Net loss per share, basic (in USD per share)	$ (0.34)	$ (0.38)	$ (1.31)	$ (1.53)
Net loss per share, diluted (in USD per share)	$ (0.34)	$ (0.38)	$ (1.31)	$ (1.53)
Weighted-average shares used to compute basic net loss per share (in shares)	47,208,192	44,848,023	46,185,209	42,436,061
Weighted-average shares used to compute diluted net loss per share (in shares)	47,208,192	44,848,023	46,185,209	42,436,061

Stock-Based Compensation - Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of Restricted Stock Units
Outstanding at beginning of period (in shares) \| shares	250,464
Restricted stock units granted (in shares) \| shares	201,884
Restricted stock units vested (in shares) \| shares	(268,930)
Outstanding at end of period (in shares) \| shares	183,418
Weighted-Average Fair Value Per Share at Grant Date
Outstanding at beginning of period (in USD per share) \| $ / shares	$ 42.99
Restricted shares units granted (in USD per share) \| $ / shares	38.75
Restricted shares units vested (in USD per share) \| $ / shares	35.88
Outstanding at end of period (in USD per share) \| $ / shares	$ 48.74

Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

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.

In November 2017, the Company entered into a seven-year operating lease for approximately 25,548 square feet of office space beginning on August 1, 2018, and expiring on August 31, 2025. In June 2019, the lease was amended to extend the expiration date to October 31, 2027. 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 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 intends to utilize its other currently-leased spaces through the lease expiration dates 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 three and nine months ended September 30, 2022, ROU assets obtained in exchange for new operating lease liabilities were $0.1 million and $0.1 million, respectively. During the three and nine months ended September 30, 2021, ROU assets obtained in exchange for new operating lease liabilities were none and $0.1 million, respectively. As of September 30, 2022 and December 31, 2021, the ROU assets had a balance of $6.4 million and $7.1 million, respectively. The operating lease ROU asset is included within the Company’s non-current other assets, and lease liabilities are included in current or noncurrent liabilities in the Company’s unaudited condensed consolidated balance sheets. During the three and nine months ended September 30, 2022, cash paid for amounts included in operating lease liabilities was $0.6 million and $1.6 million, respectively. During the three and nine months ended September 30, 2021, cash paid for amounts included in operating lease liabilities was $0.5 million and $1.5 million, respectively. Amortization of the ROU assets was $0.3 million and $0.8 million for the three and nine months ended September 30, 2022, respectively. Amortization of the ROU assets was $0.3 million and $0.8 million for the three and nine months ended September 30, 2021, respectively.

As of September 30, 2022 and December 31, 2021, the weighted-average remaining lease term for the Company’s operating leases was 5.1 years and 5.9 years, respectively. The weighted-average incremental borrowing rate for a collateralized asset of the same remaining term used to determine the present value of the Company’s operating leases’ future payments was 7.1% and 7.1% as of September 30, 2022 and December 31, 2021, respectively.

Total lease costs for the three and nine months ended September 30, 2022 and 2021 are as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
Lease cost
Operating lease cost	$	542	$	524	$	1,590	$	1,583
Short-term lease cost	24		25		65		77
Variable lease cost	91		54		164		152
Total lease cost	$	657	$	603	$	1,819	$	1,812

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 $0.6 million and $2.8 million during the three and nine months ended September 30, 2022, respectively. The Company recorded related royalties of $1.6 million and $4.5 million during the three and nine months ended September 30, 2021, respectively. Royalty expense is included in operating expenses in the unaudited condensed consolidated statements of comprehensive loss. Accrued royalties of $0.5 million and $1.8 million as of September 30, 2022 and December 31, 2021, respectively, are included within accrued liabilities in the Company’s unaudited condensed 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 United States 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 r-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.

In addition to the Medtronic Litigation, the Company is and may continue to be involved in claims, legal proceedings, and investigations arising out of its operations in the normal course of business.

Property and Equipment, Net

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Property and equipment, net consists of the following (in thousands) at:


	September 30,		December 31,
	2022		2021
Equipment	$	2,576	$	2,429
Computer hardware and software	3,304		2,450
Tools and molds	1,841		1,579
Leasehold improvements	4,448		4,372
Furniture and fixtures	1,837		1,502
Construction in progress	299		127
	14,305		12,459
Less: accumulated depreciation and amortization	(7,202)		(5,544)
	$	7,103	$	6,915

Depreciation and amortization expense of property and equipment was $0.6 million and $1.7 million for the three and nine months ended September 30, 2022, respectively. Depreciation and amortization expense of property and equipment was $0.5 million and $1.4 million for the three and nine months ended September 30, 2021, respectively.

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment, Net

Property and equipment, net consists of the following (in thousands) at:


	September 30,		December 31,
	2022		2021
Equipment	$	2,576	$	2,429
Computer hardware and software	3,304		2,450
Tools and molds	1,841		1,579
Leasehold improvements	4,448		4,372
Furniture and fixtures	1,837		1,502
Construction in progress	299		127
	14,305		12,459
Less: accumulated depreciation and amortization	(7,202)		(5,544)
	$	7,103	$	6,915

Income Taxes - Narrative (Details) $ in Millions	Dec. 31, 2021 USD ($)
Domestic Tax Authority
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	$ 258.2
Operating loss carryforwards, subject to expiration	51.5
Foreign Tax Authority
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards	16.4
State and Local Jurisdiction
Operating Loss Carryforwards [Line Items]
Operating loss carryforwards, subject to expiration	$ 245.6

Income Taxes

9 Months Ended

Sep. 30, 2022

Income Tax Disclosure [Abstract]

Income Taxes

The following table presents details of the provision for income taxes and effective tax rates (in thousands, except percentages):


	Three Months Ended September 30,		Nine Months Ended September 30,
	2022	2021	2022	2021
Income tax (benefit) expense	$(520)	$528	$(2,096)	$3,269
Effective tax rate	3.10%	3.16%	3.36%	5.30%

The Company accounts for income taxes according to ASC 740. 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. net deferred income tax assets as of September 30, 2022 and December 31, 2021.

The effective tax rate differs from the statutory U.S. income tax rate due to differing tax rates imposed on income earned in foreign jurisdictions, losses in foreign jurisdictions, and certain nondeductible expenses. The effective tax rate could change significantly from quarter to quarter because of recurring and nonrecurring factors. The provision for income taxes for the nine months ended September 30, 2022 was primarily the result of losses benefited in certain foreign jurisdictions.

At December 31, 2021, the Company had U.S. federal and foreign net operating loss (NOL) carryforwards of approximately $258.2 million and $16.4 million, respectively. U.S. federal NOLs in the amount of $51.5 million will expire between 2033 and 2037 while the remainder will carryover indefinitely. The foreign net operating loss carryforwards have an indefinite carryforward period. The Company had U.S. state NOLs of $245.6 million, which will expire between 2033 and 2041.

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. Based on the study performed in 2021, the Company determined that an ownership change did not occur in 2021.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Nature of Operations and Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

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 (r-SNM System) and non-rechargeable (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 r-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 r-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 r-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 r-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 r-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 existing r-SNM system. The new recharge-free system and Bulkamid are protected by intellectual property based on Company-generated innovations or patents acquired as part of the Contura acquisition.

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 unaudited interim condensed 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 and Liquidity

Interim Financial Statements

The unaudited interim condensed consolidated financial statements and related footnote disclosures as of and for the three and nine months ended September 30, 2022 are unaudited, and are not necessarily indicative of the Company’s operating results for a full year. The unaudited interim condensed consolidated financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial results for the three and nine months ended September 30, 2022 in accordance with United States generally accepted accounting principles (GAAP), however, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (SEC) rules and regulations relating to interim financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included within the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (filed with the SEC on March 1, 2022).

Reclassifications

Certain prior period reported amounts have been reclassified to conform with the current period presentation.

Liquidity

The Company only began full-scale commercialization of the r-SNM System in late 2019. The Company has expended significant resources on research and development activities, growing its operations organization and building and training its sales organization.

The Company incurred net losses of $60.4 million and $64.9 million for the nine months ended September 30, 2022 and 2021, respectively, and had an accumulated deficit of $374.9 million as of September 30, 2022 compared to $314.6 million at December 31, 2021. The Company expects to continue to spend a significant amount of its existing resources on sales and marketing activities as the Company continues to invest in commercializing and marketing its products in the United States and internationally.

As of September 30, 2022, the Company had cash, cash equivalents, and short-term investments of $350.0 million compared to cash and cash equivalents of $220.9 million at December 31, 2021. The Company expects that its cash, cash equivalents, and short-term investments on hand will be sufficient to fund its operations through at least the next 12 months. The Company funds its operations through a combination of proceeds from public offerings of its common stock and cash receipts from sales of its products. As of September 30, 2022, the Company had no outstanding borrowings.

The Company may need to raise additional financing in the future to facilitate its business operations. If the Company raises additional funds by issuing equity securities, its stockholders could experience dilution. Debt financing, if available, may involve covenants further restricting its operations or its ability to incur additional debt. Any debt financing or additional equity that the Company raises may contain terms that are not favorable to the Company or its stockholders. Additional financing may not be available at all, or in amounts or on terms acceptable to the Company. If the Company is unable to obtain additional financing when needed to satisfy its liquidity requirements, the Company may be required to scale back its operations.

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 r-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 since the second quarter of 2020, 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 unaudited condensed 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 nine months ended September 30, 2022 and 2021 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 expects to receive 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 September 30, 2022 and December 31, 2021, respectively, and is recorded as a reduction of gross revenue in its unaudited condensed consolidated statements of comprehensive loss. Damaged or defective products are replaced at no charge under the Company’s standard warranty. For the three and nine months ended September 30, 2022, the replacement costs were minimal and $0.1 million, respectively. For the three and nine months ended September 30, 2021, the replacement costs were minimal and $0.2 million, respectively. The replacement costs are recorded within the sales and marketing expenses in its unaudited condensed 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 September 30, 2022 and December 31, 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 three and nine months ended September 30, 2022 and 2021 (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
SNM net revenue
United States	$	55,610	$	39,147	$	147,793	$	110,135
International markets	1,249		922		3,894		3,031
	$	56,859	$	40,069	$	151,687	$	113,166
Bulkamid net revenue(1)
United States	$	11,045	$	3,921	$	27,837	$	6,870
International markets	2,480		2,923		8,260		7,119
	$	13,525	$	6,844	$	36,097	$	13,989
Total net revenue	$	70,384	$	46,913	$	187,784	$	127,155

_____________________________________________

(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 Accounting Standards Update (ASU) 2016-13. 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):


	Nine Months Ended September 30,
	2022		2021
Balance at beginning of period	$	355	$	465
Write-offs	(74)		(12)
Bad debt expense (recoveries)	17		(68)
Balance at end of period	$	298	$	385

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.

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 unaudited condensed consolidated financial statements approximate the fair value for cash and cash equivalents, short-term investments, 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, we acquired Contura Limited and its Bulkamid product, a urethral bulking agent indicated for the treatment of female SUI. In consideration for the acquisition, we paid approximately $141.3 million in cash and issued 1,096,583 shares of our common stock. We 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 September 30, 2022, the discount rates ranged from 7.0% to 8.2%, volatility was estimated at 24.0%, and risk-free rates ranged from 3.0% to 4.2%. The fair value of contingent consideration of $30.5 million at September 30, 2022, is reflected in other current liabilities in the Company’s unaudited condensed 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 in the Company’s unaudited condensed consolidated balance sheets.

The following table summarizes the changes in the fair value of recurring Level 3 fair value measurements during the nine months ended September 30, 2022 and 2021 (in thousands):


	Nine Months Ended September 30,
	2022		2021
Liabilities
Contingent consideration:
Balance at beginning of period	$	10,370	$	—
February 25, 2021 Acquisition	—		7,630
Change in fair value included in earnings	20,130		1,250
Balance at end of period	$	30,500	$	8,880

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 date of purchase are considered short-term investments. Those investments in debt securities with maturities greater than 12 months at the date of purchase 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 unaudited condensed consolidated statements of comprehensive loss. There were no unrealized gains or losses during the three and nine months ended September 30, 2022 and 2021.

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 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 September 30, 2022 (in thousands):


	Fair Value Measurements at September 30, 2022
Assets:	Level 1		Level 2		Level 3		Total
Commercial paper	$	—	$	192,797	$	—	$	192,797

U.S. government and agency securities	63,174		—		—		63,174
	$	63,174	$	192,797	$	—	$	255,971

_____________________________________________

(1) As of September 30, 2022, commercial paper investments of $143.3 million and U.S. government and agency securities of $4.0 million are included in cash and cash equivalents on the unaudited condensed consolidated balance sheets, as the investments had a maturity of three months or less from the date of purchase on the unaudited condensed consolidated balance sheets.

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 September 30, 2022 and December 31, 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 September 30, 2022 and December 31, 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 r-SNM System 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 September 30, 2022, the Company had $34.1 million, $5.7 million and $18.0 million of finished goods inventory, work-in-process inventory and raw materials inventory, respectively, net of reserves of $0.4 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 September 30, 2022 and December 31, 2021, there were no customers who accounted for over 10% of the Company’s consolidated accounts receivable. As of September 30, 2022 and December 31, 2021, there was one vendor and no vendor, respectively, who accounted for over 10% of the Company’s consolidated accounts payable. During the nine months ended September 30, 2022 and September 30, 2021, there were no customers who accounted for over 10% of the Company’s consolidated net revenue. During the nine months ended September 30, 2022 and September 30, 2021, there were three vendors and one vendor, 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 and seven years. Leasehold improvements are amortized over the lesser of the life of the lease or the useful life of the improvements. Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in operations.

Goodwill

Goodwill represents the excess purchase price over the fair values of the identifiable 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 nine months ended September 30, 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 initial public offering, 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 amortization of this intangible asset was $0.1 million during the nine months ended September 30, 2022 and 2021. The amortization of the patent license asset was minimal during the three months ended September 30, 2022 and 2021. 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 8.

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, $0.0001 par value, 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 unaudited condensed consolidated balance sheets. Amortization of this asset is recorded over the four-year term of the agreement on a straight-line basis. The Company recorded expense for the amortization of the exclusive license asset of $0.3 million and $0.7 million during the three and nine months ended September 30, 2022, respectively. There was $0.2 million and $0.4 million of amortization of this intangible asset recorded during the three and nine months ended September 30, 2021, respectively. 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 8.

Contura acquisition

The intangible assets represent technology, trade names and trademarks, and customer relationships acquired from Contura on February 25, 2021. The straight-line method over the period of estimated benefit is used to amortize finite-lived intangible assets except for customer relationships. Accounting Standards Codification (ASC) 350-30-35-3 states that customer relationships generally dissipate at a more rapid rate in the earlier periods following a company’s succession to these relationships, with the rate of attrition declining over time. As such, the accelerated method is used to amortize customer relationships. The Company recorded expense for the amortization of Contura acquisition intangible assets of $2.1 million and $6.4 million during the three and nine months ended September 30, 2022, respectively. There was $2.0 million and $4.6 million of amortization of these intangible assets recorded during the three and nine months ended September 30, 2021, respectively. The Company reviewed the intangible assets for impairment for this asset group during the three months ended September 30, 2022. As Bulkamid SARL ceased sales operations and did not recognize revenue during the three months ended September 30, 2022, and does not expect to recognize revenue in future periods, the Company wrote off the customer relationships intangible asset of $0.3 million related to this entity. The impairment expense is recorded within the general and administrative expenses in its unaudited condensed consolidated statements of comprehensive loss. For additional information, see Note 8.

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 during the three and nine months ended September 30, 2022.

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 three and nine months ended September 30, 2022.

Leases

In accordance with 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) asset 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 asset 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 costs are charged to operations as incurred. Research and development costs include salary and personnel-related costs, costs of clinical studies and testing, supplies and materials, and outside consultant costs.

Advertising Expense

The Company expenses advertising costs as they are incurred. During the three and nine months ended September 30, 2022, advertising expenses totaled $6.0 million and $15.5 million, respectively, and are recorded within the sales and marketing expenses in its unaudited condensed consolidated statements of comprehensive loss. During the three and nine months ended September 30, 2021, advertising expenses totaled $2.6 million and $5.5 million, respectively, and are recorded within the sales and marketing expenses in its unaudited condensed consolidated statements of comprehensive loss.

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

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 or four years. 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 actually become exercisable.

The Company uses the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. Stock options and restricted shares awards vest based on service conditions, typically over three or four years.

The Company also grants shares of performance-based restricted stock units that typically vest after one year only if the Company has also achieved certain performance objectives as defined and approved by the Company’s board of directors. The fair value of performance awards are determined based on the Company’s stock price at the date of grant and expensed over the performance period based on the probability of achieving the performance objectives. In addition, the Company also grants market-based restricted stock units that have combined market conditions and service conditions for vesting, for which the Company uses the Monte Carlo valuation model to value equity awards (as of the date of grant). Compensation cost is not adjusted if the market condition is not met, as long as the requisite service is provided.

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.

For the three and nine months ended September 30, 2022, there were 2,389,761 and 2,401,649 potentially dilutive weighted-average shares, respectively, that were not included in the computation of diluted weighted-average shares of common stock and common stock equivalent shares outstanding because their effect would have been antidilutive given the Company’s net loss. For the three and nine months ended September 30, 2021, there were 2,459,912 and 2,460,176 potentially dilutive weighted-average shares, respectively, that were not included in the computation of diluted weighted-average shares of common stock and common stock equivalent shares outstanding because their effect would have been antidilutive given the Company’s net loss.

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

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.

Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Jun. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Sale of stock, price per share (in USD per share)	$ 63.85	$ 50.00	$ 63.85
Closing costs	$ 192	$ 11,272	$ 192	$ 11,272
Common Stock
Follow-on offering - issuance of shares, less closing costs (in shares)	2,012,500	4,025,000

Long-Term Debt	9 Months Ended
Long-Term Debt	Sep. 30, 2022
Debt Disclosure [Abstract]
Long-Term Debt	Long-Term Debt In June 2021, the principal amount, accrued interest, accrued loan fees, and prepayment fees related to the term loan under the Loan and Security Agreement with Silicon Valley Bank entered into in February 2021, were paid in full. The unamortized debt issuance costs of $4.4 million were expensed and recognized as interest expense. In January 2021, the principal amount, accrued interest, accrued loan fees, and prepayment fees related to the term loan under the Loan and Security Agreement with Silicon Valley Bank entered into in February 2018, were paid in full. The unamortized debt issuance costs of $0.4 million were expensed and recognized as interest expense.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-URI https://asc.fasb.org/topic&trid=2208564

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1B
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495323-112611

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1C
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495334-112611

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 20
-Section 50
-Paragraph 1I
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=123466505&loc=SL123495371-112611

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Nature of Operations and Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Schedule of Revenue Disaggregated by Product and Geographic Market


	Three Months Ended September 30,				Nine Months Ended September 30,
	2022		2021		2022		2021
SNM net revenue
United States	$	55,610	$	39,147	$	147,793	$	110,135
International markets	1,249		922		3,894		3,031
	$	56,859	$	40,069	$	151,687	$	113,166
Bulkamid net revenue(1)
United States	$	11,045	$	3,921	$	27,837	$	6,870
International markets	2,480		2,923		8,260		7,119
	$	13,525	$	6,844	$	36,097	$	13,989
Total net revenue	$	70,384	$	46,913	$	187,784	$	127,155

_____________________________________________

(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):


	Nine Months Ended September 30,
	2022		2021
Balance at beginning of period	$	355	$	465
Write-offs	(74)		(12)
Bad debt expense (recoveries)	17		(68)
Balance at end of period	$	298	$	385

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 nine months ended September 30, 2022 and 2021 (in thousands):


	Nine Months Ended September 30,
	2022		2021
Liabilities
Contingent consideration:
Balance at beginning of period	$	10,370	$	—
February 25, 2021 Acquisition	—		7,630
Change in fair value included in earnings	20,130		1,250
Balance at end of period	$	30,500	$	8,880

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 September 30, 2022 (in thousands):


	Fair Value Measurements at September 30, 2022
Assets:	Level 1		Level 2		Level 3		Total
Commercial paper	$	—	$	192,797	$	—	$	192,797

U.S. government and agency securities	63,174		—		—		63,174
	$	63,174	$	192,797	$	—	$	255,971

_____________________________________________

Long-Term Debt - Narrative (Details) - Term Loans - USD ($) $ in Millions	1 Months Ended
	Jun. 30, 2021	Jan. 31, 2021
Term Loan Two
Debt Instrument [Line Items]
Unamortized debt issuance costs	$ 4.4
Interest expense	$ 4.4
Term Loan One
Debt Instrument [Line Items]
Unamortized debt issuance costs		$ 0.4
Interest expense		$ 0.4

Condensed 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 (in shares) at Dec. 31, 2020		39,931,030
Balance at beginning 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 (in shares)		206,507
Issuance of common stock for employee stock option exercises for cash	2,821		2,821
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		358,300
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	3,809		3,809
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation (in shares)		169,054
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,494		1,494
Issuance of common stock for acquisition of Contura Limited (in 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 (in shares)		65,594
Issuance of common stock for exclusive license asset	3,637		3,637
Foreign currency translation adjustment	(2,202)				(2,202)
Net loss	(22,503)			(22,503)
Balance at end of period (in shares) at Mar. 31, 2021		41,827,068
Balance at end of period at Mar. 31, 2021	330,154	$ 4	589,785	(257,002)	(2,633)
Balance at beginning of period (in shares) at Dec. 31, 2020		39,931,030
Balance at beginning 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 acquisition of Contura Limited	55,728
Foreign currency translation adjustment	(6,481)
Net loss	(64,901)
Balance at end of period (in shares) at Sep. 30, 2021		46,258,758
Balance at end of period at Sep. 30, 2021	490,090	$ 5	796,397	(299,400)	(6,912)
Balance at beginning of period (in shares) at Mar. 31, 2021		41,827,068
Balance at beginning of period at Mar. 31, 2021	330,154	$ 4	589,785	(257,002)	(2,633)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock for employee stock option exercises for cash (in shares)		206,921
Issuance of common stock for employee stock option exercises for cash	2,095		2,095
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		31,975
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	4,381		4,381
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,946		1,946
Follow-on offering - issuance of shares, less closing costs (in shares)		4,025,000
Follow-on offering - issuance of shares, less closing costs	189,978	$ 1	189,977
Foreign currency translation adjustment	859				859
Net loss	(25,148)			(25,148)
Balance at end of period (in shares) at Jun. 30, 2021		46,090,964
Balance at end of period at Jun. 30, 2021	504,265	$ 5	788,184	(282,150)	(1,774)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock for employee stock option exercises for cash (in shares)		86,894
Issuance of common stock for employee stock option exercises for cash	1,523		1,523
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		80,900
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	4,723		4,723
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,967		1,967
Foreign currency translation adjustment	(5,138)				(5,138)
Net loss	(17,250)			(17,250)
Balance at end of period (in shares) at Sep. 30, 2021		46,258,758
Balance at end of period at Sep. 30, 2021	$ 490,090	$ 5	796,397	(299,400)	(6,912)
Balance at beginning of period (in shares) at Dec. 31, 2021	46,330,167	46,330,167
Balance at beginning 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 (in shares)		91,286
Issuance of common stock for employee stock option exercises for cash	1,444		1,444
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		312,479
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	5,633		5,633
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation (in shares)		268,930
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,505		1,505
Foreign currency translation adjustment	(4,920)				(4,920)
Net loss	(22,668)			(22,668)
Balance at end of period (in shares) at Mar. 31, 2022		47,002,862
Balance at end of period at Mar. 31, 2022	$ 463,432	$ 5	812,141	(337,234)	(11,480)
Balance at beginning of period (in shares) at Dec. 31, 2021	46,330,167	46,330,167
Balance at beginning 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 acquisition of Contura Limited	0
Foreign currency translation adjustment	(29,625)
Net loss	$ (60,363)
Balance at end of period (in shares) at Sep. 30, 2022	49,479,594	49,479,594
Balance at end of period at Sep. 30, 2022	$ 549,518	$ 5	960,627	(374,929)	(36,185)
Balance at beginning of period (in shares) at Mar. 31, 2022		47,002,862
Balance at beginning of period at Mar. 31, 2022	463,432	$ 5	812,141	(337,234)	(11,480)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock for employee stock option exercises for cash (in shares)		35,803
Issuance of common stock for employee stock option exercises for cash	480		480
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		79,051
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	6,490		6,490
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,415		1,415
Foreign currency translation adjustment	(12,648)				(12,648)
Net loss	(21,443)			(21,443)
Balance at end of period (in shares) at Jun. 30, 2022		47,117,716
Balance at end of period at Jun. 30, 2022	437,726	$ 5	820,526	(358,677)	(24,128)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common stock for employee stock option exercises for cash (in shares)		220,114
Issuance of common stock for employee stock option exercises for cash	3,577		3,577
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation (in shares)		129,264
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	6,776		6,776
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	1,442		1,442
Follow-on offering - issuance of shares, less closing costs (in shares)		2,012,500
Follow-on offering - issuance of shares, less closing costs	128,306		128,306
Foreign currency translation adjustment	(12,057)				(12,057)
Net loss	$ (16,252)			(16,252)
Balance at end of period (in shares) at Sep. 30, 2022	49,479,594	49,479,594
Balance at end of period at Sep. 30, 2022	$ 549,518	$ 5	$ 960,627	$ (374,929)	$ (36,185)

Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted (in shares)	0		0
Weighted-average grant date fair value of options granted (in USD per share)		$ 33.08		$ 32.93
Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation cost related to unvested stock options	$ 2.8		$ 2.8		$ 6.7
Weighted-average period of recognition of compensation cost			1 year 1 month 6 days		1 year 7 months 6 days
Weighted-average remaining contractual term of options outstanding and exercisable			6 years 3 months 18 days		6 years 10 months 24 days
Restricted Shares Awards
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted-average period of recognition of compensation cost			2 years 6 months		3 years
Unrecognized compensation cost related to unvested RSAs or RSUs	56.1		$ 56.1		$ 42.5
Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted-average period of recognition of compensation cost			9 months 18 days		10 months 24 days
Unrecognized compensation cost related to unvested RSAs or RSUs	$ 2.8		$ 2.8		$ 1.9