Cover Page
Cover Page - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 01, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36545 | ||
Entity Registrant Name | INTERSECT ENT, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-0280837 | ||
Entity Address, Address Line One | 1555 Adams Drive | ||
Entity Address, City or Town | Menlo Park | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94025 | ||
City Area Code | 650 | ||
Local Phone Number | 641-2100 | ||
Title of 12(b) Security | Common Stock, 0.001 par value | ||
Trading Symbol | XENT | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 565,464 | ||
Entity Common Stock, Shares Outstanding (in shares) | 33,787,505 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for its 2022 Annual Stockholders’ Meeting are incorporated by reference into Part III of this Annual Report on Form 10-K, to be filed within 120 days of the registrant’s fiscal year ended December 31, 2021. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001271214 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Indianapolis, Indiana |
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 38,397 | $ 13,521 |
Short-term investments | 22,618 | 74,506 |
Accounts receivable, net | 17,326 | 14,592 |
Inventories, net | 18,599 | 12,054 |
Assets held for sale | 5,353 | 0 |
Prepaid expenses and other current assets | 3,704 | 3,494 |
Total current assets | 105,997 | 118,167 |
Property and equipment, net | 4,995 | 5,624 |
Operating lease right-of-use assets | 15,149 | 17,151 |
Intangible assets, net | 0 | 21,193 |
Goodwill | 0 | 46,639 |
Restricted cash | 17,887 | 17,500 |
Other non-current assets | 2,839 | 1,107 |
Total assets | 146,867 | 227,381 |
Current liabilities: | ||
Accounts payable | 8,888 | 6,042 |
Accrued compensation | 20,501 | 13,559 |
Deferred acquisition related consideration, current | 17,013 | 21,071 |
Liabilities held for sale | 5,353 | 0 |
Other current liabilities | 5,405 | 3,575 |
Total current liabilities | 57,160 | 44,247 |
Operating lease liabilities | 14,709 | 17,736 |
Long-term debt | 127,346 | 63,650 |
Deferred acquisition related consideration, non-current | 15,409 | 33,167 |
Deferred tax liability | 0 | 1,569 |
Other non-current liabilities | 1,312 | 0 |
Total liabilities | 215,936 | 160,369 |
Commitments and contingencies | ||
Stockholders’ equity (deficit): | ||
Preferred stock | 0 | 0 |
Common stock, $0.001 par value; Authorized shares: 150,000; Issued and outstanding shares: 33,641 as of December 31, 2021 and 32,936 as of December 31, 2020 | 34 | 33 |
Additional paid-in capital | 393,617 | 370,053 |
Accumulated other comprehensive income (loss) | (10) | 1 |
Accumulated deficit | (462,710) | (303,075) |
Total stockholders’ equity (deficit) | (69,069) | 67,012 |
Total liabilities and stockholders’ equity (deficit) | $ 146,867 | $ 227,381 |
Preferred stock, shares authorized (in shares) | 9,994,000 | 9,994,000 |
Series DF-1 Convertible Preferred Stock | ||
Stockholders’ equity (deficit): | ||
Preferred stock | $ 0 | $ 0 |
Preferred stock, shares authorized (in shares) | 6,310 | 6,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Stockholders’ equity (deficit): | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 9,994,000 | 9,994,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 33,641,000 | 32,936,000 |
Common stock, shares outstanding (in shares) | 33,641,000 | 32,936,000 |
Series DF-1 Convertible Preferred Stock | ||
Stockholders’ equity (deficit): | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 6,310 | 6,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | |||
Revenue | $ 106,748 | $ 80,554 | $ 109,142 |
Cost of sales | 30,012 | 30,306 | 21,773 |
Gross profit | 76,736 | 50,248 | 87,369 |
Operating expenses: | |||
Selling, general and administrative | 122,068 | 98,550 | 108,480 |
Research and development | 27,944 | 19,350 | 24,283 |
Impairment on assets held for sale | 67,765 | 0 | 0 |
Total operating expenses | 217,777 | 117,900 | 132,763 |
Loss from operations | (141,041) | (67,652) | (45,394) |
Interest expense | (6,437) | (2,752) | 0 |
Other income (expense), net | (13,847) | (2,331) | 2,400 |
Loss before income taxes | (161,325) | (72,735) | (42,994) |
Income tax (benefit) | (1,690) | (416) | 0 |
Net loss | (159,635) | (72,319) | (42,994) |
Other comprehensive income: | |||
Unrealized (loss) gain on short-term investments, net | (11) | (52) | 94 |
Comprehensive loss | $ (159,646) | $ (72,371) | $ (42,900) |
Net loss per share, basic and diluted (in usd per share) | $ (4.80) | $ (2.22) | $ (1.37) |
Weighted average common shares used to compute net loss per share, basic and diluted (in shares) | 33,272 | 32,615 | 31,388 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholder's Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at beginning of period (in shares) at Dec. 31, 2018 | 30,745 | ||||
Balance at beginning of period at Dec. 31, 2018 | $ 120,994 | $ 31 | $ 308,766 | $ (41) | $ (187,762) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and exercise of stock options (in shares) | 1,490 | ||||
Issuance of common stock and exercise of stock options | 19,548 | $ 1 | 19,547 | ||
Stock-based compensation expense | 20,416 | 20,416 | |||
Unrealized (loss) gain on short-term investments, net | 94 | 94 | |||
Net loss | (42,994) | (42,994) | |||
Balance at end of period (in shares) at Dec. 31, 2019 | 32,235 | ||||
Balance at end of period at Dec. 31, 2019 | 118,058 | $ 32 | 348,729 | 53 | (230,756) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and exercise of stock options (in shares) | 701 | ||||
Issuance of common stock and exercise of stock options | 6,904 | $ 1 | 6,903 | ||
Stock-based compensation expense | 14,421 | 14,421 | |||
Unrealized (loss) gain on short-term investments, net | (52) | (52) | |||
Net loss | (72,319) | (72,319) | |||
Balance at end of period (in shares) at Dec. 31, 2020 | 32,936 | ||||
Balance at end of period at Dec. 31, 2020 | 67,012 | $ 33 | 370,053 | 1 | (303,075) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock and exercise of stock options (in shares) | 705 | ||||
Issuance of common stock and exercise of stock options | 7,288 | $ 1 | 7,287 | ||
Stock-based compensation expense | 16,277 | 16,277 | |||
Unrealized (loss) gain on short-term investments, net | (11) | (11) | |||
Net loss | (159,635) | (159,635) | |||
Balance at end of period (in shares) at Dec. 31, 2021 | 33,641 | ||||
Balance at end of period at Dec. 31, 2021 | $ (69,069) | $ 34 | $ 393,617 | $ (10) | $ (462,710) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | |||
Net loss | $ (159,635) | $ (72,319) | $ (42,994) |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation and amortization | 4,812 | 2,841 | 2,667 |
Non-cash lease expense | 1,977 | 2,225 | 1,234 |
Stock-based compensation expense | 16,456 | 14,958 | 20,149 |
Amortization of net investment premium (discount) | 673 | 378 | (1,201) |
Amortization of debt transaction costs and accretion of debt discount | 938 | 561 | 0 |
Impairment of property, equipment, and intangible assets | 775 | 0 | 0 |
Impairment on assets held for sale | 67,765 | 0 | 0 |
Interest expense on deferred acquisition related costs | 1,865 | 494 | 0 |
Loss (gain) on foreign currency forward contracts | 3,044 | (833) | 0 |
Foreign currency remeasurement loss (gain) | (2,498) | 2,233 | 0 |
Change in fair value of embedded derivatives | 13,138 | 1,248 | 0 |
Income tax (benefit) | (1,690) | (416) | 0 |
Income tax (benefit) | (1,800) | (436) | 0 |
Changes in operating assets and liabilities, net of held for sale: | |||
Accounts receivable, net | (4,279) | 5,001 | 503 |
Inventories, net | (10,297) | 6,578 | (5,148) |
Prepaid expenses and other assets | (4,520) | (564) | (14) |
Accounts payable | 4,170 | 1,483 | (1,236) |
Accrued compensation | 9,411 | 498 | 437 |
Other liabilities | (1,572) | (40) | (1,648) |
Net cash used in operating activities | (59,467) | (35,694) | (27,251) |
Investing activities: | |||
Purchases of short-term investments | (23,688) | (139,350) | (110,267) |
Maturities of short-term investments | 74,892 | 99,606 | 132,885 |
Proceeds from sale of short-term investments | 0 | 34,794 | 0 |
Purchases of property and equipment | (2,024) | (873) | (3,727) |
Cash paid for acquisition, net | 0 | (16,922) | 0 |
Net cash provided by (used in) investing activities | 49,180 | (22,745) | 18,891 |
Financing activities: | |||
Proceeds from debt financing, net of issuance costs | 49,588 | 61,841 | 0 |
Payment of deferred acquisition related consideration | (20,288) | 0 | 0 |
Proceeds from issuance of common stock and exercise of stock options | 7,288 | 6,903 | 19,548 |
Net cash provided by financing activities | 36,588 | 68,744 | 19,548 |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (390) | 64 | 0 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 25,911 | 10,369 | 11,188 |
Cash, cash equivalents, and restricted cash: | |||
Beginning of the period | 31,021 | 20,652 | |
Reclassification to assets held for sale during the period | (648) | 0 | 0 |
End of the period, excluding amounts classified as assets held for sale | 56,284 | 31,021 | 20,652 |
Supplementary cash flow information of non-cash investing and financing activities: | |||
Right-of-use asset obtained in exchange for lease obligations | 0 | 0 | 117 |
Right-of-use asset remeasurement related to lease extension | 362 | 7,129 | 11,525 |
Lessor funded building improvements | 670 | 0 | 152 |
Deferred purchase consideration for a business combination | 0 | 51,341 | 0 |
Property and equipment included in accounts payable | 6 | 34 | 104 |
Supplementary cash flow information: | |||
Cash paid for interest on long-term debt | $ 3,014 | $ 1,033 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Intersect ENT, Inc. (the “Company”) is incorporated in the state of Delaware and is headquartered in Menlo Park, California. The Company is a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care. The Company’s U.S. Food and Drug Administration (“FDA”) approved products are steroid releasing implants designed to treat patients suffering from chronic rhinosinusitis (“CRS”) who are managed by ENT physicians. These products include the PROPEL ® family of products (PROPEL ® , PROPEL ® Mini and PROPEL ® Contour) and the SINUVA ® (mometasone furoate) Sinus Implant. The PROPEL family of products are used in conjunction with sinus surgery primarily in hospitals and ambulatory surgery centers (“ASC”) and increasingly in the physician office setting of care in conjunction with balloon dilation and following post-surgical debridement. SINUVA is designed to be used in the physician office setting of care to treat patients who have had ethmoid sinus surgery yet suffer from recurrent sinus obstruction due to polyps. The PROPEL family of products are combination products regulated as devices approved under a Premarket Approval (“PMA”) and SINUVA is a combination product regulated as a drug that was approved under a New Drug Application (“NDA”). The PROPEL family of products have also received CE Markings, permitting them to be marketed in the European Economic Area. In October 2020, the Company acquired Fiagon AG Medical Technologies (“Fiagon”), a global leader in electromagnetic surgical navigation solutions with an expansive portfolio of ENT product offerings, including the VenSure sinus dilation balloon (“ VenSure ”), CUBE Navigation System (“CUBE”), and instruments that complement the Company’s PROPEL and SINUVA sinus implants and extend its geographic reach. The VenSure products received 510(k) clearance in August 2020 and the latest version of the CUBE Navigation System received 510(k) clearance in July 2021. In addition, some of the Fiagon products are registered in other countries including in Asia Pacific and South America. The Company continues to invest in research and development in order to expand its portfolio of products and improve its existing products. Pending Acquisition On August 6, 2021 the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Medtronic, Inc., a Minnesota corporation and wholly-owned subsidiary of Medtronic public limited company (“Medtronic”), and Project Kraken Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Medtronic (“Merger Sub”), providing for the merger of Merger Sub with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly-owned subsidiary of Medtronic. On October 8, 2021, the Company’s stockholders adopted the Merger Agreement at a special meeting of its stockholders. Under the terms of the Merger Agreement, Medtronic will acquire all outstanding shares of the Company’s common stock in exchange for consideration of $28.25 per share in cash , including all vested and unvested awards, in exchange for consideration of $28.25 per share in cash. Vested and unvested stock options will be redeemed for the difference between $28.25 per option and the respective exercise price. The Merger Agreement contains representations and warranties customary for transactions of this type. The closing of the Merger is subject to the satisfaction or waiver of a number of closing conditions, including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The Merger Agreement provides Medtronic and the Company with certain termination rights and, under certain circumstances, may require that Medtronic or the Company pay a termination fee. In anticipation of the Merger and with respect to antitrust considerations, the Company has committed to a plan to divest of the recently acquired Fiagon business, which the Company expects to be contingent on and coterminous with the anticipated Merger, and has therefore presented the related assets and liabilities as held for sale on the consolidated balance sheets as of December 31, 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). These consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. Risks and Uncertainties The Company is subject to risks and uncertainties resulting from the COVID-19 pandemic. The Company cannot predict the extent or duration of the impact of the COVID-19 pandemic on its financial and operating results, as the information regarding the current environment is evolving. Due to the COVID-19 pandemic, the Company’s business has been and will continue to be impacted by patients’ decisions whether or not to undergo sinus surgeries and, as a result, ENT ASC and office procedure volumes may fluctuate. The Company’s operations may be further impacted by COVID-19 due to changes in our manufacturing operations as a result of any future regulations or guidance issued by local and federal authorities. Furthermore, the COVID-19 pandemic has led to severe disruption and volatility in global capital markets and increased economic uncertainty and instability. The magnitude of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to: the duration and severity of the pandemic is unknown and could continue longer, and be more severe, than the Company currently expects; the duration, extent and re-occurrence of restrictions impacting its manufacturing operations; the unknown state of the U.S. economy following the pandemic; the level of demand for the Company’s products as the pandemic subsides; and the time it will take for the economy to recover from the pandemic. As of the date of these consolidated financial statements, the extent to which the COVID-19 pandemic may materially adversely impact the Company’s financial results, operating results, or liquidity is uncertain. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its revenue related allowances, inventory, common stock valuation and related stock-based compensation, leases, business combinations, embedded derivatives, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash equivalents, short-term investments and accounts receivable. The Company believes that the credit risk in its accounts receivable is mitigated by its credit evaluation process, relatively short collection terms and diversity of its customer base. The Company generally does not require collateral and losses on accounts receivable have historically been within management’s expectations. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies, and institutions with investment-grade credit ratings, as well as corporate debt or commercial paper issued by the highest quality financial and non-financial companies, and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents and issuers of investments to the extent recorded on the balance sheets. The Company has limited its credit risk associated with cash, cash equivalents and short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated investments. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid securities, readily convertible to cash, that mature within 90 days or less from the date of purchase to be cash equivalents. In association with the acquisition of Fiagon, as of December 31, 2021 and 2020, the Company placed $17.9 million and $17.5 million, respectively with an escrow agent with the seller as beneficiary. These escrow balances are presented as non-current restricted cash on the Company’s consolidated balance sheets based on the timing of the related deferred acquisition payments. The following table summarizes the Company’s cash, cash equivalents, and restricted cash as of December 31, 2021 and 2020 (in thousands): December 31, 2021 2020 Cash and cash equivalents $ 38,397 $ 13,521 Restricted cash 17,887 17,500 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 56,284 $ 31,021 Short-term Investments Short-term investments, which are classified as available-for-sale, represent highly liquid debt instruments with maturities greater than 90 days at date of purchase. Such investments are recorded at fair value and unrealized holding gains and losses are reported as a separate component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit) until realized. The Company reviews its investment portfolio periodically to assess for other-than-temporary impairment. Should the Company determine that any unrealized losses on the investments are other-than-temporary, the amount of that impairment to be recognized in earnings will depend on whether the Company intends to sell the security or more likely than not will be required to sell the security before recovery of its amortized cost basis less any current period credit loss. Refer to the credit losses accounting policy for further discussion. The specific identification method is used to determine the cost of securities disposed of, with realized gains and losses reflected other income (expense), net in the consolidated statements of operations and comprehensive loss. Inventories Inventories are valued at the lower of cost, computed on a first-in, first-out basis, or net realizable value. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of facility expense, freight, handling costs, and consumption are expensed as incurred, and not included in allocable overhead. The Company maintains provisions for excess and obsolete inventory based on its estimates of forecasted demand and, where applicable, product expiration. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally two Implementation Costs in a Cloud Computing Arrangement The Company capitalizes qualified implementation costs incurred in a hosting arrangement that is a service contract for which it is the customer in accordance with the requirements for capitalizing costs incurred to develop internal-use software. These capitalized implementation costs are recorded within prepaid and other current assets or other non-current assets, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis. Impairment of Long-lived Assets Long-lived assets consist primarily of property and equipment and definite-lived intangible assets and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require that a long-lived asset be tested for possible impairment, the Company compares the undiscounted cash flows expected to be generated, performed at the lowest level of identifiable cash flows, which is at the individual asset level or at the asset group level, to the carrying value of the related asset or asset group. If the carrying amount of the long-lived asset is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying amount exceeds its fair value. The Company determines fair value using the income approach based on the present value of expected future cash flows or other appropriate measures of estimated fair value. The Company’s cash flow assumptions consider historical and forecasted revenue and operating costs and other relevant factors. During the year ended December 31, 2021, the Company recognized impairment expense of $0.6 million related to certain property and equipment, primarily recorded in selling, general and administrative expense in the consolidated statements of operations and comprehensive loss. Leases For agreements with a term of more than twelve months, the Company determines if an agreement is a lease at inception. Operating lease liabilities represent an obligation to make lease payments arising from the lease agreement. Operating lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the remaining lease term. In determining the present value of lease payments, the Company estimates its incremental borrowing rate as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, of an amount equal to the lease payments in a similar economic environment. Operating lease liabilities are classified as other current and non-current liabilities on our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and are classified as other non-current assets. Lease expense is recognized on a straight-line basis over the expected lease term. Restructuring Activities During the year ended December 31, 2020, as a response to the COVID-19 pandemic, the Company took pre-emptive actions to curtail spending as its business, revenues, and cash flows had been and were expected to be significantly impacted by the suspension of medical procedures involving its products. These actions included reducing its workforce by 96 employees, or approximately 25% of its workforce. In addition, the Company furloughed 18 employees, or approximately 5% of its workforce, and provided for the cost of certain benefits for those employees while furloughed. The charges related to these actions, including severance benefits for terminated employees and the benefits for furloughed employees, were approximately $0.2 million for the year ended December 31, 2020. The restructuring activities are complete and there are no remaining accrued liabilities related to restructuring activities as of December 31, 2021. Embedded Derivatives Related to Convertible Debt Instruments During 2020, the Company issued convertible debt with embedded derivatives that are required to be bifurcated from their host contract and remeasured to fair value at each balance sheet date. Any resulting gain or loss related to the change in the fair value of the embedded derivative is being recorded to other income (expense), net in the consolidated statements of operations and comprehensive loss. Changes in the Company’s assumptions, such as the estimated probability of triggering events and other inputs to the valuation of the embedded derivatives, such as the Company’s stock price, could result in material changes in the valuation in future periods. Business Combinations Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Deferred acquisition related consideration incurred in connection with a business combination is recorded at its present value upon the acquisition, with any resulting accretion expense recorded as interest expense in the consolidated statements of operations and comprehensive loss. Assets Held for Sale The Company considers assets to be held for sale when management approves and commits to a plan to dispose of an asset or disposal group. Assets or disposal groups held for sale are recorded initially at the lower of carrying value or estimated fair value, less estimated costs to sell, and adjusted quarterly. Any initial loss and quarterly changes are limited to the carrying value at the date of held for sale classification and are reflected in impairment on assets held for sale in the consolidated statements of operations and comprehensive loss. Upon designation as an asset held for sale or disposal group, the Company stops recording depreciation and amortization expense on such assets. Costs to sell a disposal group include incremental direct costs to transact the sale and represent the costs that result directly from and are essential to a sale transaction that would not have been incurred by the entity had the decision to sell not been made. To the extent that there are losses in excess of the carrying value as of the date of held for sale classification of the assets or disposal group, the losses are recognized upon the date of sale. The various assets and liabilities of a disposal group are classified as held for sale and presented separately in the appropriate current asset and current liability sections of the consolidated balance sheets prior to the date of sale. See Note 8 for more information. Goodwill and Acquired Intangible Assets Goodwill represents the excess of the purchase price over the fair value of net identifiable assets and liabilities and is allocated to reporting units on a relative fair value basis. Goodwill is not amortized but is tested for impairment at least annually during the third quarter, or if circumstances indicate their value may no longer be recoverable. The Company operates in two segments and has combined them into a single reportable segment as one of them is insignificant and has a majority of economic characteristics that are similar in nature to the other. Intangible assets acquired in a business combination are recorded at fair value. Identifiable finite-lived intangible assets are amortized over the period of estimated benefit on a straight-line basis, reflecting the pattern of economic benefits associated with these assets. The estimated useful lives of the Company’s finite-lived intangible assets generally range from three . Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. To determine revenue recognition for arrangements that the Company determines are within the scope of Accounting Standards Codification Topic 606: Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies the performance obligations. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The contracts are typically in the form of a purchase order from the customer. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. The Company’s typical payment terms are between approximately 30 to 90 days. The Company expenses shipping and handling costs as incurred and includes them in the cost of sales. In those cases where shipping and handling costs are billed to customers, the Company classifies the amounts billed as a component of revenue. Taxes collected from customers and remitted to governmental authorities are excluded from revenues. The Company expenses any incremental costs of obtaining a contract as and when incurred as the expected amortization period of the incremental costs would have been less than one year. The PROPEL family of products are regulated by the FDA as medical devices. The Company recognizes revenue through sales of its PROPEL family of products to hospitals and ASC located almost entirely in the United States when control of the product is transferred to the customer, typically upon shipment of goods to the customer, satisfying the Company’s only performance obligation. The FDA has approved SINUVA as a drug and it is therefore regulated as such. The Company sells SINUVA to a limited number of specialty pharmacies and specialty distributors in the United States, (“Resellers”). These Resellers subsequently sell SINUVA to health care providers. Revenue from SINUVA sales are recognized when control of the product is transferred to the Resellers, typically upon receipt of goods by the Reseller, satisfying the Company’s only performance obligation. The Company recognizes Reseller fees, prompt pay discounts, product sales discounts, rebates, returns and other allowances as an estimated reduction of revenue in the same period the related revenue is recognized. In addition to the agreements with the Resellers, the Company enters into arrangements with governmental agencies that result in rebates, chargebacks and discounts with respect to the purchase of SINUVA. These amounts may include Medicaid and Tricare rebates, chargebacks related to Federal Supply Schedule of the General Services Administration, Distribution and Pricing Agreement with the Department of Defense and 340B of the Public Health Service Act as well as other allowances that may be offered within contracts between the Company and its direct or indirect customers relating to the Company’s sales of SINUVA, collectively referred to as “Discounts and Rebates.” Discounts and Rebates are based on amounts owed or expected to be owed on the related sales. These estimates take into consideration the Company’s historical experience, the remaining shelf life of the product, current contractual and statutory requirements, specific known market events and trends and industry data. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect revenue and earnings in the period such variances become known. On the consolidated balance sheets, such amounts are generally classified as reductions of accounts receivable if the amount is payable to the Resellers, or a current liability if the amount is payable to a party other than the Reseller. Multiple-Element Arrangements The Company may, from time to time, enter into lease arrangements with certain qualified customers in connection with commitments to purchase consumable products to accompany the use of the equipment. Leases have terms that generally range from 24 to 48 months and are usually collateralized by a security interest in the underlying assets. For all periods presented, revenue from these arrangements was not material. Cost of Sales Cost of sales consists primarily of manufacturing overhead costs, material costs, and direct labor. A significant portion of the Company’s cost of sales consists of manufacturing overhead costs. These overhead costs include compensation, including stock-based compensation and other operating expenses associated with the cost of quality assurance, material procurement, inventory control, facilities, information technology, equipment and operations supervision and manufacturing and warehouse management. Cost of sales also includes depreciation expense for production equipment, amortization of intangible assets associated with acquired product technologies and processes, maintenance of operational processes, and certain direct costs such as shipping costs. Research and Development Research and development expenses consist primarily of product development, clinical and regulatory affairs, consulting services and other costs associated with products and technologies in development. These expenses include employee compensation, including stock-based compensation, supplies, quality assurance and related travel and allocated facilities and information technology expenses. Clinical expenses include clinical trial design, clinical site reimbursement, data management and travel expenses, and the cost of manufacturing products for clinical trials. Foreign Currency The functional currency of the Company’s wholly-owned subsidiaries is the U.S. dollar. When the transactional currency is different than the functional currency, transaction gains and losses are included as a component of other income (expense), net. Monetary assets and liabilities denominated in foreign currencies are remeasured at exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are measured at rates in effect on the dates the assets were acquired or liabilities were assumed. Revenues and expenses related to monetary items are measured at rates of exchange prevailing on the transaction dates, while expenses relating to non-monetary items are measured at historical rates. Gains and losses on remeasurement are reflected in other income (expense), net when incurred. In November 2020, the Company entered into foreign currency forward contracts as economic hedges to protect against volatility of foreign exchange rate exposure of its deferred acquisition consideration liabilities, which are stated in Euros. The forward contracts are not designated for hedge accounting and are remeasured at fair value with gains or losses reported in other income (expense), net. Credit Losses The Company is exposed to credit losses primarily through receivables from customers and distribution partners and through its available-for-sale debt securities. The Company’s expected loss allowance methodology for the receivables is developed using historical collection experience, current and future economic market conditions, a review of the current aging status, and the financial condition of its customers and distribution partners. Specific allowance amounts are established to record the appropriate allowance for customers that have an identified specific risk of default. General allowance amounts are established based upon the Company’s assessment of expected credit losses for its receivables by aging category. Balances are written off when they are ultimately determined to be uncollectible. The Company’s expected loss allowance methodology for the debt securities is developed by reviewing the extent of the unrealized loss, the size, term, geographical location, industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. Stock-based Compensation The Company maintains equity incentive plans to provide long-term incentives for employees and members of the Board of Directors. The plans allow for the issuance of non-statutory and incentive stock options and restricted stock units to employees and non-statutory stock options to non-employee directors. The Company is required to determine the fair value of equity incentive awards and recognize compensation expense for all equity incentive awards made to employees and directors, including employee stock options and restricted stock units. Stock-based compensation expense is recognized over the requisite service period in the consolidated statements of operations and comprehensive loss. The Company uses the straight-line method for expense attribution for awards with service-based conditions only, and uses an accelerated attribution method for awards with performance and market conditions. The Company has elected to account for forfeitures when they occur. The valuation model used for calculating the fair value of awards for stock-based compensation expense, except for market-based awards, is the Black-Scholes option-pricing model (the “Black-Scholes model”). For market-based awards, the Monte Carlo simulation model (the “Monte Carlo simulation”) is used. Both the Black-Scholes model and Monte Carlo simulation require the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted average period of time that the awards granted are expected to be outstanding), the volatility of the Company’s common stock and an assumed risk-free interest rate. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected term of the option. Compensation expense for awards that include a combination of performance and market conditions is also reassessed quarterly taking into consideration the expected outcome of the performance component. Advertising Expenses The Company expenses the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $1.3 million , $0.8 million and $1.2 million during the years ended December 31, 2021, 2020 and 2019, respectively. Income Taxes The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. Valuation allowances against deferred tax assets are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company’s policy is to record interest related to uncertain tax positions within interest expense and any penalties within other income (expense), net in the consolidated statement of operations and comprehensive loss. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and common stock equivalent shares from dilutive stock options, employee stock purchases and restricted stock units outstanding during the period, as well as stock issuable upon the conversion of the Convertible Notes. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods as all potentially dilutive securities were antidilutive in those periods. The following potentially dilutive securities outstanding have been excluded from the computations of weighted average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): Year Ended 2021 2020 2019 Common stock options 2,930 3,172 3,209 Market-based performance stock options 427 427 427 Restricted stock units 528 488 511 Market-based performance stock units 269 130 89 Employee stock purchase plan shares — 63 70 Stock issuable upon conversion of convertible notes 6,309 6,309 — 10,463 10,589 4,306 The Company uses the if-converted method for calculating any potential dilutive effects of the Convertible Notes. The Company did not adjust the net losses for the years ended December 31, 2021 and 2020 to eliminate any interest expense related to the Convertible Notes (see Note 11) in the computation of diluted loss per share, or calculate the potential common shares from conversion, as the effects would have been anti-dilutive. The shares presented above represent the maximum number of convertible shares which can be issued subject to the make-whole increase to the conversion rate upon certain events. Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on short-term investments. Segment, Geographical and Customer Concentration The Company operates in two segments and has combined them into a single reportable segment as one of them is insignificant and has a majority of economic characteristics that are similar in nature to the other. The Company’s long-lived tangible assets and revenue are predominantly based in the United States. No single customer accounted for more than 10% of revenue during the years ended December 31, 2021, 2020 and 2019, and no single customer accounted for more than 10% of accounts receivable as of December 31, 2021 and 2020. Accounting Pronouncements Recently Adopted Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. ASU 2019-12 became effective for the Company beginning in 2021. The adoption of the standard did not result in a material impact to the Company’s consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt- Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) . ASU 2020-06 modifies and simplifies accounting for convertible instruments. The new guidance eliminates certain separation models that require separating embedded conversion features from convertible instruments. ASU 2020-06 also addresses how convertible instruments are accounted for in the diluted earnings per share calculation. The Company early adopted this standard and became effective beginning in 2021. The adoption of the standard had no impact to the Company’s consolidated financial statements. In October 2020, the FASB issued ASU No. 2020-08, Codification Improvements to Subtopic 310-20, Receivables- Nonrefundable Fees and Other Costs (“ASU 2020-08”). ASU 2020-08 clarifies the accounting for the amortization period for certain purchased callable debt securities held at a premium by giving consideration to securities which have multiple call dates. ASU 2020-08 became effective for the Company beginning in 2021. The adoption of the standard had no impact to the Company’s consolidated financial statements. |
Composition of Certain Financia
Composition of Certain Financial Statement Items | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Composition of Certain Financial Statement Items | Composition of Certain Financial Statement Items Accounts Receivable, net (in thousands): December 31, 2021 2020 Accounts receivable $ 17,948 $ 15,079 Allowance for doubtful accounts (622) (487) $ 17,326 $ 14,592 The reserve for credit losses on accounts receivable for the years ended December 31, 2021, 2020, and 2019 were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Beginning $ 487 $ 131 $ 80 Additions from acquisition — 175 — Charges, net of recoveries 332 221 94 Write-offs (140) (40) (43) Reclassification to held for sale (57) — — Ending $ 622 $ 487 $ 131 Inventories, net (in thousands): December 31, 2021 2020 Raw materials $ 3,122 $ 2,865 Work-in-process 4,113 3,411 Finished goods 11,364 5,778 $ 18,599 $ 12,054 In 2020, as a result of a shut-down in production associated with shelter-in-place orders by state authorities and the Company’s decision to extend the suspension of production for an additional period of time, production volume was less than normal and the Company recorded associated idle capacity expense of $6.1 million. Due to a decline in projected product sales, the Company also increased its reserve for excess and obsolete inventory by $0.8 million during the year ended December 31, 2020. During the year ended December 31, 2021, the Company operated at normal capacity and no such charges were recorded. Inventory reserves were $1.1 million and $1.5 million as of December 31, 2021 and 2020, respectively. Capitalized stock-based compensation expense of $0.1 million and $0.3 million was included in inventory as of December 31, 2021 and 2020, respectively. Property and Equipment, net (in thousands): December 31, 2021 2020 Computer equipment and software $ 2,370 $ 2,159 Furniture and office equipment 1,598 1,611 Laboratory and manufacturing equipment 8,057 8,939 Leasehold improvements 4,103 3,385 16,128 16,094 Less: accumulated depreciation and amortization (11,133) (10,470) $ 4,995 $ 5,624 Cloud Computing Implementation Costs During the year ended December 31, 2021, the Company capitalized certain implementation costs associated with hosting arrangements that are service contracts. The implementation costs primarily pertained to a new company-wide ERP system, customer relationship management software, and human resource management software. Total implementation costs capitalized and the amortization expense during the year ended December 31, 2021 was $3.6 million and $0.2 million, respectively. As of December 31, 2021, capitalized implementation costs of $1.1 million and $2.2 million were presented in prepaid expenses and other current assets and other non-current assets, respectively. Disaggregation of Revenues The following table disaggregates our product sales by product (in thousands): Year Ended December 31, 2021 2020 2019 PROPEL family of products $ 91,117 $ 74,335 $ 104,657 SINUVA 9,074 5,315 4,485 VenSure, CUBE, and accessories 6,557 904 — $ 106,748 $ 80,554 $ 109,142 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments, and convertible debt embedded derivatives. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: Level 1 — Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2 — Other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Level 3 — Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The fair value of marketable securities classified within Level 2 is based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. If the carrying value of a definite-lived or indefinite-lived intangible asset is not recoverable, an impairment loss is recognized based on the amount by which the carrying value exceeds the estimated fair value. The inputs used in the fair value analysis fall within Level 3 of the fair value hierarchy due to the use of significant unobservable inputs to determine the fair value. Cash, Cash Equivalents and Short-term Investments The following is a summary of the Company’s unrealized gains and losses related to its cash, cash equivalents, and short-term investments in marketable securities designated available-for-sale (in thousands): Reported as: Amortized Gross Unrealized Estimated Cash and cash Short-term December 31, 2021 Gains Losses Level 1: Cash $ 9,101 $ — $ — $ 9,101 $ 9,101 $ — Money market funds 29,296 — — 29,296 29,296 — 38,397 — — 38,397 38,397 — Level 2: U.S. treasury bills 7,080 — (5) 7,075 — 7,075 Corporate debt securities 9,557 — (5) 9,552 — 9,552 Commercial paper 5,991 — — 5,991 — 5,991 22,628 — (10) 22,618 — 22,618 $ 61,025 $ — $ (10) $ 61,015 $ 38,397 $ 22,618 Reported as: Amortized Gross Unrealized Estimated Cash and cash Short-term December 31, 2020 Gains Losses Level 1: Cash $ 9,755 $ — $ — $ 9,755 $ 9,755 $ — Money market funds 2,762 — — 2,762 2,762 — 12,517 — — 12,517 12,517 — Level 2: U.S. treasury bills 49,698 4 (3) 49,699 1,004 48,695 Corporate debt securities 6,307 — (2) 6,305 — 6,305 U.S. government agency bonds 19,504 3 (1) 19,506 — 19,506 75,509 7 (6) 75,510 1,004 74,506 $ 88,026 $ 7 $ (6) $ 88,027 $ 13,521 $ 74,506 There were no transfers in and out of Level 1 and Level 2 during the years ended December 31, 2021, 2020, and 2019. The following table summarizes the contractual maturity of the Company’s cash equivalents and short-term investments as of December 31, 2021 (excluding cash and money-market funds): Amortized Cost Fair Value Maturity in less than one year $ 19,617 $ 19,609 Maturity in one to five years 3,011 3,009 Total $ 22,628 $ 22,618 As of December 31, 2020, the Company had no investments with a contractual maturity of greater than one year. Actual maturities may differ from contractual maturities, because certain borrowers have the right to call or prepay certain obligations. Based on an evaluation of securities that have been in a loss position, the Company did not recognize any other-than-temporary impairment charges during the years ended December 31, 2021, 2020 and 2019. The Company considered various factors which included a credit and liquidity assessment of the underlying securities and the Company’s intent and ability to hold the underlying securities until the estimated date of recovery of its amortized cost. The Company concluded that any unrealized losses on investments as of December 31, 2021 and 2020 were not attributed to credit. Convertible Notes Embedded Derivatives The Convertible Notes due in 2025 (see Note 11) have embedded features which were required to be bifurcated upon issuance and then periodically remeasured separately as embedded derivatives. These embedded features include additional make-whole interest payments which may become payable to the lender upon certain events, such as a change in control, upon optional redemption by the Company, or a sale of all or substantially all of the Company’s assets. The embedded features also include additional shares depending on the time to maturity and the stock price which may be added to an early conversion upon certain events. The Company has utilized a convertible lattice model to determine the fair value of the embedded features, which utilizes inputs including the common stock price, volatility of common stock, credit rating, probability of certain triggering events, and time to maturity. The fair value measurements of the embedded derivatives are classified as Level 3 financial instruments. As of December 31, 2021, the fair value of the embedded features was $16.2 million and has been presented together with the Convertible Notes host instrument on the consolidated balance sheets. Changes in the fair value of the Company’s Level 3 liabilities were as follows (in thousands): December 31, Balance as of December 31, 2019 $ — Additions 1,800 Fair value adjustment 1,248 Balance as of December 31, 2020 3,048 Additions — Fair value adjustment 13,138 Balance as of December 31, 2021 $ 16,186 The change in fair value of embedded derivatives for the year ended December 31, 2021 was a $13.1 million loss compared to a $1.2 million loss for the year ended December 31, 2020, each of which was recorded in other income (expense), net in the Company’s consolidated statements of operations and comprehensive loss. The increase in the fair value of the embedded derivative liability during the year ended December 31, 2021 was due to the increased probability of triggering events as a result of the pending acquisition with Medtronic. |
Derivative Financial Instrument
Derivative Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | Derivative Financial Instruments The Company’s deferred purchase consideration related to the Fiagon acquisition exposed it to foreign currency exchange risk between rate fluctuations of the U.S. dollar and the Euro. To manage this risk, the Company entered into a series of foreign currency exchange forward contracts. In general, gains and losses related to these contracts are expected to be substantially offset by corresponding gains and losses on the remeasurement of the deferred purchase consideration each reporting period. The risk of loss in the event of a counterparty default is limited to the amount of any unrealized gains on outstanding contracts (e.g., those contracts that have a positive fair value) at the date of default. The Company does not enter into derivative contracts for trading purposes. During the year ended December 31, 2021, one of the foreign currency forward contracts was exercised in order to make the first deferred acquisition payment for the Fiagon acquisition. The derivative instruments the Company uses to economically hedge this exposure are not designated as accounting hedges and, as a result, changes in their fair value are recorded in other income (expense), net in its consolidated statements of operations and comprehensive loss. The derivative assets and liabilities are measured using Level 2 fair value inputs. The Company had gross notional amounts (in EUR) with USD equivalents of $36.9 million and $55.0 million on foreign currency exchange contracts not designated as hedging instruments outstanding as of December 31, 2021 and 2020 as follows (in thousands): Year Ended December 31, 2021 2020 Notional amounts: Forward contracts €30,000 €45,000 Gross fair value recorded in: Prepaid expenses and other current assets $ — $ 275 Other non-current assets $ — $ 558 Other current liabilities $ 1,141 $ — Other non-current liabilities $ 1,070 $ — The following table summarizes the effect of the Company’s foreign currency exchange contracts on its consolidated statements of operations and comprehensive loss recognized in other income (expense), net (in thousands): Year Ended December 31, 2021 2020 Recognized gains (losses) on foreign currency exchange contracts $ (3,045) $ 833 Foreign exchange gains (losses) on remeasurement of deferred acquisition related consideration $ 3,785 $ (2,388) |
Business Combinations
Business Combinations | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Combinations | Business Combinations On October 2, 2020, the Company acquired all of the outstanding equity interests of Fiagon and its subsidiaries. Fiagon develops, and commercializes globally, innovative electromagnetic surgical navigation systems and an associated suite of surgical tools and sinus dilation balloons targeted to the ENT surgical space. The transaction increases the Company’s product portfolio as well as its ability to serve customers and patients in the U.S., Europe and elsewhere. Assets and operations acquired included developed technologies, a distribution network, customer relationships, trademarks, certain personnel, and net tangible assets, which collectively met the definition of a business. Under the terms of the Purchase Agreement for the acquisition of Fiagon, the Company made an initial €15.0 million ($17.6 million) payment upon closing in October 2020, made the first €15.0 million as well as a €2.5 million working capital purchase price adjustment in October 2021, and will make €15.0 million annual payments for each of the subsequent two years. The total purchase consideration is denominated in Euros with an equivalent value of $69.3 million, which included an upfront cash payment of $17.6 million, and deferred payments of $51.7 million, of which $17.5 million (€15.0 million equivalent) of cash was placed in escrow with the seller as beneficiary. The amount placed in escrow is required to be adjusted to the equivalent of €15.0 million on January 15th and July 15th of each year based on the end of the prior month’s five-day trailing exchange rate. The restrictions on cash held in escrow will be released upon payment of the last deferred purchase payment due in October 2023. In addition, the Company entered into agreements to pledge the shares of Fiagon and its intellectual property as security for the deferred payments. The share pledge expires upon payment of the last deferred purchase payment due in October 2023 and the intellectual property pledge expires upon payment of the third installment due in October 2022. The Company recorded $4.6 million of tangible assets, primarily consisting of $2.2 million of inventory, offset by liabilities assumed of $4.2 million, including deferred tax liabilities of $2.2 million. In addition, the Company recorded $21.9 million of intangible assets and $46.6 million in residual goodwill. Goodwill arising from the business combination consists largely of the synergies and economies of scale expected from combining the operations of the Company and Fiagon, as well as the value of Fiagon’s assembled workforce. Intangible assets included patents and developed technology, a distribution network, customer relationships, and trademarks, which were originally to be amortized over a period of 9.1 years. The Company’s management utilized a specialist to assist in the valuation. Key assumptions included in the valuation were (1) the amount and timing of future revenues, expenses, and other cash flows, and (2) the discount rate used to determine the present value of these cash flows. The goodwill is not amortizable for income tax purpos es. During the year ended December 31, 2021, the Company finalized it s purchase accounting and recorded a measurement period adjustment to increase goodwill and purchase consideration by $0.4 million, to $47.0 million upon agreement with the Sellers of the installment payment paid in October 2021, and as a result of completing its assessment of tax exposure related to pre-acquisition peri ods. For the years ended December 31, 2021 and 2020 , the Company has included the results of the acquired business, since its acquisition date, in its consolidated financial statements. For the years ended December 31, 2021 and 2020 , Fiagon contributed approximately $6.6 million and $0.9 million in revenue, as well as $10.5 million and $2.3 million in net loss, respectively. As of the date of acquisition, the total amount of deferred consideration was recorded at its present value. At the end of each reporting period, accretion of the liability is recorded to interest expense in the consolidated statements of operati ons and comprehensive loss. For the years ended December 31, 2021 and 2020, $1.9 million and $0.5 million of interest expense was recorded, respectively. As of December 31, 2021 and 2020, the present value of the deferred acquisition consideration was $32.4 million and $54.2 million, respectively . The liability is discounted at a market participant’s borrowing rate for debt instruments with similar maturities, security, and other characteristics. Total costs recognized with the transaction to date are $6.1 million of transaction and integration costs, which have been recognized in selling, general and administrative expense in the consolidated statements of operations and comprehensive loss. The following unaudited pro forma condensed combined financial information gives effect to the acquisition of Fiagon as if it was consummated on January 1, 2019 (the beginning of the comparable reporting period), and includes pro forma adjustments including interest expense, cost of sales, foreign exchange and imputed interest impacts of the deferred consideration, amortization of intangibles, and direct and incremental transaction costs reflected in the historical financial statements. Specifically, the following adjustments were made: • For the year ended December 31, 2020, the Company increased interest expense by $0.8 million, increased other expense from foreign currency remeasurement by $1.5 million, and reduced selling, general and administrative expenses by $0.6 million. • For the year ended December 31, 2019, the Company increased cost of sales by $0.6 million, increased selling, general and administrative expenses by $6.5 million, including $4.0 million related to non-recurring acquisition and integration costs, increased interest expense by $1.9 million, and increased other income by $1.2 million from foreign currency remeasurement. Year Ended December 31, 2020 2019 (Unaudited, in thousands) Revenue $ 82,797 $ 120,998 Net loss (77,504) (50,707) Net loss per share, basic and diluted (2.38) (1.62) Pro forma financial information is not necessarily indicative of the Company’s actual results of operations if the acquisition had been completed at the date indicated, nor is it necessarily an indication of future operating results. Goodwill The Company completed its annual goodwill impairment assessment during the third quarter of 2021 and determined that no indicators of impairment existed. Subsequently, as of December 31, 2021, the Company committed to a plan to divest of the Fiagon business in contemplation of the pending transaction with Medtronic. The circumstances surrounding the divestiture of Fiagon significantly reduced the estimated fair value of the business. As a result, goodwill was fully impaired as of December 31, 2021. Refer to Note 8 for further details. Acquired Intangible Assets The following table summarizes the components of gross intangible asset, accumulated amortization, and net intangible asset balances as of December 31, 2020 (in thousands): December 31, Gross Carrying Amount Accumulated Amortization Net Carrying Amount Developed technology $ 19,100 $ (478) $ 18,622 Distribution network 1,100 (92) 1,008 Customer relationships 1,500 (125) 1,375 Trademarks 200 (12) 188 Total intangible assets $ 21,900 $ (707) $ 21,193 Amortization expense related to intangible assets was $2.8 million and $0.7 million for the years ended December 31, 2021 and 2020, respectively. During the year ended December 31, 2021, the Company recognized impairment expense of $0.2 million, related to the remaining trademarks’ value as a result of a decision to rebrand the associated products, which was recorded in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases As of December 31, 2021, the Company had four leased facilities under operating lease agreements. Rent expense was $5.2 million , $4.3 million and $2.4 million during the years ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021, two of the leased facilities were classified as held for sale. See Note 8 for further details. Operating lease liabilities (in thousands): December 31, 2021 2020 Current portion presented in other current liabilities $ 1,975 $ 762 Non-current portion presented in operating lease liabilities 14,709 17,736 $ 16,684 $ 18,498 Cash paid for amounts included in the measurement of lease liabilities for the years ended December 31, 2021, 2020 and 2019, was $4.4 million, $2.2 million, and $1.8 million, respectively, and were included in net cash used in operating activities in the consolidated statements of cash flows. Future minimum annual operating lease payments are as follows (in thousands): Years Ending December 31, December 31, 2021 2022 $ 3,645 2023 4,088 2024 4,126 2025 4,058 2026 4,200 Thereafter 4,347 Total minimum payments 24,464 Less: present value adjustment (5,931) Less: tenant improvement allowance (1,849) Total $ 16,684 December 31, 2021 2020 Weighted-average remaining lease term (years) 5.9 6.8 Weighted-average discount rate 9.5 % 9.5 % |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Series DF-1 Convertible Preferred Stock The Company’s Board of Directors has designated 6,310 shares of the authorized 10,000,000 shares of preferred stock, $0.001 par value per share, as Series DF-1 Convertible Preferred Stock (the “Series DF-1 Preferred Stock”). Each share of Series DF-1 Preferred Stock is non-voting and convertible to 1,000 shares of the Company’s Common Stock. There is an aggregate of 6,309,459 shares of common stock issuable upon conversion of the Series DF-1 Preferred Stock. The Series DF-1 Preferred Stock does not have voting rights but is eligible for dividends or distributions on an as-converted basis. 2014 Equity Incentive Plan In July 2014, the Company’s Board of Directors approved the 2014 Equity Incentive Plan (the “2014 Plan”). Under the 2014 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and certain other awards to individuals who are employees, officers, directors or consultants of the Company. A total of 4,750,000 shares of common stock were initially reserved for issuance under the 2014 Plan. The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2015, and continuing through and including January 1, 2024, by 3% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. The maximum number of shares that may be issued upon the exercise of incentive stock options (“ISOs”) under the 2014 Plan is 10.0 million. ISOs and non-statutory stock options (“NSOs”) may be granted with exercise prices at no less than 100% of the fair value of the common stock on the date of grant. ISOs granted under the 2014 Plan generally vest 25% after the completion of twelve months of service and the balance vests in equal monthly installments over the next 36 months of service and expire 10 years from the grant date. New shares are issued upon exercise of options under the stock plan. On January 1, 2021, the total number of shares of common stock reserved for issuance increased by 988,070 shares to 10,922,838 shares reserved since the inception of the 2014 Plan. As of December 31, 2021, 3,625,223 shares remained available for issuance. In January 2017, the Company began issuing restricted stock units (“RSUs”) under the 2014 Plan. The RSUs generally vest annually over three years. The following is a summary of the Company’s stock option activity and related information (options in thousands): Year Ended Options Weighted Average Outstanding, beginning of period 3,599 $ 22.01 Granted 943 22.52 Exercised (388) 14.63 Forfeited (797) 25.33 Outstanding, end of period 3,357 22.22 Exercisable 1,574 23.22 Outstanding options as of December 31, 2021, include an option subject to both service and market-based vesting conditions to purchase 427,147 shares of the Company’s common stock with an exercise price of $20.44. As of December 31, 2021, these stock options remain unvested. As of December 31, 2021, the aggregate pre-tax intrinsic value of options outstanding was $19.6 million and options outstanding and exercisable was $8.6 million , as calculated based on the closing price of the Company’s common stock at the end of the period, the weighted-average remaining contractual term of options outstanding was 7.6 years and options outstanding and exercisable was 6.6 years . The aggregate pre-tax intrinsic value of options exercised was $4.0 million , $2.0 million and $11.4 million during the years ended December 31, 2021, 2020 and 2019, respectively. The following is a summary of the Company’s RSU activity and related information (RSUs in thousands): Year Ended RSUs Weighted Average Outstanding, beginning of period 488 $ 23.88 Awarded 385 23.40 Vested (210) 24.10 Forfeited (135) 23.33 Outstanding, end of period 528 23.58 As of December 31, 2021, the aggregate pre-tax intrinsic value of RSUs outstanding was $14.4 million, calculated based on the closing price of the Company’s common stock at the end of the period, and the weighted-average remaining vesting term of RSUs outstanding was 1.9 years. The Company has granted Performance Stock Units (“PSUs”), which are subject to service, performance, and market-based vesting conditions. The following is a summary of the Company’s PSU activity and related information (PSUs in thousands): Year Ended PSUs Weighted Average Outstanding, beginning of period 130 $ 15.94 Awarded 188 24.99 Forfeited (49) 21.93 Outstanding, end of period 269 21.16 2021 Grants In February 2021 and April 2021, the Company granted 166,708 PSUs and 20,687 PSUs, respectively. The shares subject to the PSUs will vest in two tranches, one on the second anniversary from the date of grant provided that certain 2022 revenue targets are met, and the other tranche will vest on the third anniversary from the date of grant. The PSUs will vest ranging between 50%, and 150% depending on 2022 minimum revenue levels ranging from $126.0 million to $161.0 million respectively, with $140.0 million set as the target. Furthermore, the award is subject to a total shareholder return (“TSR”) multiplier measured based on the 30-day average stock price prior to the beginning of the performance period against the average 30-day stock price at the end of the performance period. The TSR Multiplier will be applied at 0.8, 1.0, and 1.2 for the 25th percentile and below, the 50th percentile, and 75th percentile and above, respectively. Upon the end of the two-year period following the date of grant, any remaining unvested shares will be cancelled. The grant date fair value of the PSUs was $4.7 million, as estimated with the Monte Carlo simulation model, using the following assumptions: expected volatility of 61.0%; expected risk-free interest rate of 0.1%, and expected dividend yield of zero percent. The fair value of this award is expected to be recognized ratably over the requisite service period from the date of grant. Compensation cost is recognized based on the highest probable achievement of the performance criteria and was $1.3 million for the year ended December 31, 2021. 2020 Grants In February 2020, the Company granted 102,685 PSUs. The shares subject to the PSUs will vest on the third anniversary from the date of grant provided that certain 30-day trailing average stock price targets ($37, $46 and $55, respectively) are achieved at any time during the three-year period following the date of grant. Upon the end of the three-year period following the date of grant, any remaining unvested shares will be cancelled. The grant date fair value of the PSUs was $1.8 million, as estimated with the Monte Carlo simulation model, using the following assumptions: expected volatility of 46.7%; expected risk-free interest rate of 1.3%, and expected dividend yield of zero percent. The fair value of this award is expected to be recognized ratably over the three-year service period from the date of grant. 2019 Grants In July 2019, the Company granted stock options subject to both service and market-based vesting conditions to purchase 427,147 shares of the Company’s common stock with an exercise price of $20.44. The shares subject to this option will vest on the third anniversary from the date of grant provided that certain 30-day trailing average stock price targets ($32, $40 and $48, respectively) are achieved at any time during the three-year period following the date of grant. Upon the end of the three-year period following the date of grant, any remaining unvested shares will be cancelled. The grant date fair value of this option was $2.9 million, as estimated with the Monte Carlo simulation model, using the following assumptions: expected volatility of 47.3%; expected risk-free interest rate of 1.9%; expected term of 6.5 years; and expected dividend yield of zero percent. The fair value of this option is expected to be recognized ratably over the three-year service period from the date of grant. In November 2019, the Company granted 89,024 PSUs, subject to both service and market-based vesting conditions. The shares subject to the PSUs will vest on the third anniversary from the date of grant provided that certain 30-day trailing average stock price targets ($28, $34 and $41, respectively) are achieved at any time during the three-year period following the date of grant. Upon the end of the three-year period following the date of grant, any remaining unvested shares will be cancelled. The grant date fair value of the PSUs was $1.3 million, as estimated with the Monte Carlo simulation model, using the following assumptions: expected volatility of 47.3%; expected risk-free interest rate of 1.6%; and expected dividend yield of zero percent. The fair value of this award is expected to be recognized ratably over the three-year service period from the date of grant. As of December 31, 2021, the aggregate pre-tax intrinsic value of PSUs outstanding was $7.3 million , calculated based on the closing price of the Company’s common stock at the end of the period, and the weighted-average remaining vesting term of PSUs outstanding was 1.5 years . 2014 Employee Stock Purchase Plan |
Stock-based Compensation Expens
Stock-based Compensation Expense | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation Expense | Stock-based Compensation Expense Total stock-based compensation expense recognized is as follows (in thousands): Year Ended 2021 2020 2019 Cost of sales $ 1,543 $ 1,805 $ 1,273 Selling, general and administrative 12,901 11,493 15,709 Research and development 2,012 1,660 3,167 $ 16,456 $ 14,958 $ 20,149 As of December 31, 2021, the total compensation expense not yet recognized for the 2014 Plan was $27.5 million . This expense will be recognized ratably over a weighted average period of 2.3 years and will be adjusted for subsequent forfeitures. For stock options, the Company estimates the fair value of stock-based compensation on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes model determines the fair value of stock-based payment awards based on the fair market value of the Company’s common stock on the date of grant and is affected by assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to, the fair market value of the Company’s common stock, volatility over the expected term of the awards and actual and projected employee stock option exercise behaviors. The Company has opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The historical volatility data was computed using the daily closing prices for the included companies’ shares during the equivalent period of the calculated expected term of the share-based payments. The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history of not paying dividends and its expectation that it will not declare dividends for the foreseeable future. The fair value of options granted to employees or directors during the periods presented below were estimated as of the grant date using the Black-Scholes model assuming the weighted average assumptions listed in the following table: Year Ended 2021 2020 2019 Expected term (years) 6.0 6.0 6.0 Expected volatility 66.0 % 58.0 % 48.0 % Risk-free interest rate 0.7 % 0.9 % 2.2 % Dividend yield 0.0 % 0.0 % 0.0 % Fair value $ 13.29 $ 10.87 $ 11.74 The fair value of stock purchase rights granted under the 2014 ESPP to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted average assumptions listed in the following table: Year Ended 2021 2020 2019 Expected term (years) 0.5 0.5 0.5 Expected volatility 52.0 % 82.0 % 49.0 % Risk-free interest rate 0.0 % 0.1 % 2.0 % Dividend yield 0.0 % 0.0 % 0.0 % Fair value $ 5.29 $ 5.67 $ 6.71 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt Convertible Notes On May 11, 2020, in order to finance the Company’s commercial activities as well as for general corporate purposes, the Company entered into a Facility Agreement (the “Facility Agreement”) by and among the Company, as borrower, and Deerfield Partners, L.P. (“Deerfield”), as agent for itself and the lenders, providing for the issuance and sale by the Company to Deerfield of $65.0 million of principal amount of 4.0% unsecured senior convertible notes (the “Convertible Notes”) upon the terms and conditions set forth in the Facility Agreement. The $65.0 million principal amount of the Convertible Notes is not payable until the maturity date of May 9, 2025, unless earlier converted or redeemed. The Convertible Notes are convertible into shares of the Company’s common stock, at a conversion rate of 64.3501 shares per $1,000 principal amount of Convertible Notes, which represents an initial conversion price of $15.54. The net proceeds from the sale of the Convertible Notes were approximately $61.8 million after deducting the expenses payable by the Company. The Convertible Notes bear interest at 4.0% per annum, payable quarterly in arrears on July 1, October 1, January 1 and April 1 of each year, commencing July 1, 2020. The Convertible Notes are convertible at any time at the option of the holders thereof, provided that Deerfield is prohibited from converting the Convertible Notes into shares of common stock if, as a result of such conversion, the converting holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding (the “Beneficial Ownership Cap”). Pursuant to the Convertible Notes, the holders of the Convertible Notes have the option to demand repayment of all outstanding principal, any unpaid interest accrued thereon, and make-whole interest in connection with a Major Transaction (as defined in the Convertible Notes), which shall include, among others, any acquisition or other change of control of the Company; the sale or transfer of assets of the Company equal to more than 50% of the Enterprise Value (as defined in the Convertible Notes) of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time shares of the Company’s common stock are not listed on an Eligible Market (as defined in the Convertible Notes). The Facility Agreement contains certain specified events of default, the occurrence of which would entitle the holders of the Convertible Notes to immediately demand repayment of all outstanding principal and accrued interest on the Convertible Notes, together with a make-whole payment as determined pursuant to the Facility Agreement. Such events of default include, among others, failure to make any payment under the Convertible Notes when due, failure to observe or perform any covenant under the Facility Agreement or the other transaction documents related thereto (subject in certain cases to specified cure periods), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company and a material default by the Company under other indebtedness. On or after the date that is the second anniversary of the issuance date (May 11, 2022), the Company may redeem up to $32.5 million of the principal amount of Convertible Notes if: • the volume weighted average price of the common stock on each of any twenty (20) trading days during a period of thirty (30) consecutive trading days ending on the date which an optional redemption notice is delivered; • the volume weighted average price of the common stock on the last trading day of such period; and • the closing price of the common stock on the last trading day of such period, in each case, are greater than 150% of the conversion price. On or after the date that is the third anniversary of the issuance date (May 11, 2023), the Company may redeem up to the entire $65.0 million original principal amount of Convertible Notes if: • the volume weighted average price of the common stock on each of any twenty (20) trading days during a period of thirty (30) consecutive trading days ending on the date which an optional redemption notice is delivered; • the volume weighted average price of the common stock on the last trading day of such period; and • the closing price of the common stock on the last trading day of such period, in each case, are greater than 200% of the conversion price. The Company is obligated to notify the holders of the Convertible Notes no less than ten trading days nor more than sixty calendar days prior to any such redemption. During the period from the date on which the Company delivers an optional redemption notice until the date the optional redemption price is paid to holders, if a holder elects to convert its Convertible Notes, it will receive the shares otherwise issuable upon conversion of the Convertible Notes, plus an additional number of shares determined in accordance with the Convertible Notes. To the extent the holder would be prohibited due to the Beneficial Ownership Cap to convert its Convertible Notes during such period, such holder would be entitled to convert all or any portion of its Convertible Notes into shares of Series DF-1 Preferred Stock of the Company (such conversion, a “Preferred Stock Conversion”). The number of Series DF-1 Preferred Stock issuable upon a Preferred Stock Conversion shall be determined by dividing the number of shares of common stock of the Company that it would be entitled to receive from such conversion by 1,000. See Note 9 for discussion on the rights and privileges of Series DF-1 Preferred Stock. Upon any conversion of the Convertible Notes in connection with a major transaction, redemption of the Convertible Notes in connection with a major transaction or an optional redemption, holders of the Convertible Notes will also be entitled to a make-whole increase to the conversion rate or make-whole interest provision. The Company is subject to a number of affirmative and restrictive covenants pursuant to the Facility Agreement, including covenants regarding compliance with applicable laws and regulations, maintenance of property, payment of taxes, maintenance of insurance, business combinations, incurrence of additional indebtedness, prepayments of other unsecured indebtedness and transactions with affiliates, among other covenants. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions. As of December 31, 2021, the Company was in compliance with all covenants pertaining to the Convertible Notes. Certain features in the Convertible Notes are accounted for as embedded derivatives bifurcated from the principal balance of the Convertible Notes. See Note 4 for further discussion on the valuation of the embedded derivatives. Upon issuance, the fair value of the embedded derivatives was $1.8 million. A corresponding convertible debt discount and transaction costs of $1.8 million and $3.2 million, respectively were recorded on the issuance date and are netted against the principal amount of the Convertible Notes. Transaction costs related to the issuance of the Convertible Notes primarily comprised of underwriters’, legal, accounting and other professional fees. As of December 31, 2021 and 2020, the net carrying amount of the Convertible Notes recorded within long-term debt on the consolidated balance sheets was as follows (in thousands): December 31, 2021 2020 Outstanding principal amount of convertible notes $ 65,000 $ 65,000 Unamortized debt discount and transaction costs (3,485) (4,398) Fair value of embedded derivatives 16,186 3,048 Convertible notes, net $ 77,701 $ 63,650 The convertible debt discount and transaction costs are being amortized to expense over the term of the Notes. For the year ended December 31, 2021 and 2020 , the accretion of the convertible debt discount and amortization of debt issuance costs was $0.9 million and $0.6 million, respectively, and was included in interest expense in the consolidated statements of operations and comprehensive loss. The accrued interest on the outstanding principal of $65.0 million as of both December 31, 2021 and 2020 was $0.7 million and was included in other current liabilities on the consolidated balance sheets. The fair value of debt is based on the amount of future cash flows associated with the instrument discounted using the Company’s estimated market rate as well as a convertible lattice model for the embedded features. As of December 31, 2021, the fair value of the Company’s Convertible Notes was $133.9 million . Deerfield Loans On July 22, 2021, the Company entered into an additional agreement with Deerfield, providing for the issuance and sale by the Company to Deerfield of senior secured loans of an aggregate principal of up to $60.0 million (the “Deerfield Loans”). The Deerfield Loans will mature on July 22, 2026, unless earlier repaid or accelerated. The agreement provides for the disbursement of the Deerfield Loans in three tranches of $20.0 million, with the initial tranche disbursed on the Closing Date, the second tranche to be disbursed at the option of the Company on the earlier of the date of any prepayment of the remaining Fiagon acquisition payments and September 15, 2022, and the third tranche to be disbursed at the option of the Company on the earlier of the date of any prepayment of the remaining Fiagon acquisition payments and September 15, 2023. The Deerfield Loans bear interest at 7.5% per annum, payable quarterly in arrears on October 15, January 15, April 15, and July 15 of each year, commencing October 15, 2021, as well as a 0.25% charge on undrawn tranches. The Company ’ s obligations under the Deerfield Loans are required to be guaranteed by all of its existing and future subsidiaries (other than certain excluded and immaterial subsidiaries). The Company’s and each subsidiary guarantor’s obligations under the Deerfield Loans and agreement are secured by substantially all of the Company’s and each subsidiary guarantor’s assets, which includes springing control of the Company’s primary deposit and security accounts pursuant to a Deposit Account Control Agreement and Security Account Control Agreement. Deerfield has the ability to exercise exclusive control of these accounts by providing a Notice of Exclusive Control in response to an event of default. As of December 31, 2021, n o such notice has been received. In addition, as of December 31, 2021, the Company was not compliant with certain nonfinancial covenants within the terms of the Deerfield Loans and subsequently received a waiver of the noncompliance from the lender. The Deerfield Loans will not be permitted to be prepaid prior to 30 months after the Closing Date (the “No Call Date”), except in connection with a change of control. The Company will have the right, but not the obligation, to prepay the Deerfield Loans at any time after the No Call Date, together with accrued and unpaid interest on the principal amount prepaid, plus an exit fee equal to 1.75% of the principal amount of the Deerfield Loans to be prepaid, plus a prepayment premium equal to (a) 0.75% of the principal amount of the Deerfield Loans to be prepaid, if such prepayment occurs after the No Call Date but on or prior to the fourth anniversary of the Closing Date and (b) 0.50% of the principal amount of the Deerfield Loans to be prepaid, if such prepayment occurs after the fourth anniversary of the Closing Date but prior to the fifth anniversary of the Closing Date; provided that upon any prepayment in connection with a change of control, in lieu of such prepayment premium and the exit fee, the Company will be required to pay a prepayment premium equal to 9.75% of the principal amount being prepaid and the principal amount of any prepayments made within three months of such change of control (the “Change of Control/Acceleration Premium”). The Change of Control/Acceleration Premium is also payable upon any acceleration of the Deerfield Loans upon an event of default. In addition, if a change of control occurs, the Company enters into any definitive agreement the consummation of which would result in a change of control of the Company or announces any prospective change of control, in each case within three months of any prepayment or prepayment in full of the Deerfield Loans prior to the maturity date, then, upon the consummation of such change of control, the Company will be required to pay an additional amount equal to the Change of Control/Acceleration Premium applicable to the principal amount of Deerfield Loans prepaid within three months of such change of control, less any prepayment premiums and exit fees paid in connection with such prior prepayments. The Company is subject to a number of affirmative and restrictive covenants pursuant to the agreement, including covenants regarding minimum cash and minimum revenue, compliance with applicable laws and regulations, maintenance of property, payment of taxes, maintenance of insurance, business combinations, incurrence of additional indebtedness, prepayments of other indebtedness and transactions with affiliates, among other covenants. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions. The Deerfield Loans contain certain specified events of default, the occurrence of which would entitle the holders of the Deerfield Loans to immediately demand repayment of all outstanding principal and accrued interest on the Loans, together with a prepayment premium equal to 9.75% of the outstanding principal amount of the Deerfield Loans to be prepaid. Such events of default include, among others, failure to make any payment under the Loans when due, failure to observe or perform any covenant under the Facility Agreement or the other transaction documents related thereto (subject in certain cases to specified cure periods), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company, a material default by the Company under other indebtedness, and the occurrence of a change of control. As of December 31, 2021, the Company had not complied with certain administrative nonfinancial covenants required under the Deerfield Loans. The lender subsequently waived these instances of non-compliance. As of December 31, 2021, the net carrying amount of the Deerfield Loans recorded within long-term debt on the consolidated balance sheets was as follows: December 31, Outstanding principal amount of loans $ 20,000 Unamortized debt discount and transaction costs (387) Accrued exit fee 31 Deerfield loans, net $ 19,644 The debt discount and transaction costs associated with the Deerfield Loans are being amortized to interest expense over the term of the Deerfield Loans. For the year ended December 31, 2021 , the accretion of the debt discount and amortization of debt issuance costs was immaterial. The accrued interest on the outstanding principal of $20.0 million as of December 31, 2021 was $0.3 million and was included in other current liabilities on the consolidated balance sheets. As of December 31, 2021 , the fair value of Deerfield Loans approximated its carrying value. Medtronic Financing On September 25, 2021, the Company entered into a financing arrangement with Medtronic (the “Medtronic Financing”), providing for unsecured subordinated loans of an aggregate principal amount of up to $75.0 million to the Company upon the terms and conditions of the Medtronic Financing. The Medtronic Financing will mature one hundred eighty (180) days following the earlier of (x) the Maturity Date of the Deerfield Loans and (y) the date on which the Deerfield Loans have been fully paid in cash and are terminated, unless earlier repaid or accelerated. The Medtronic Financing provides for the draw of funds by the Company in up to five tranches of $15.0 million, with a tranche permitted to be drawn each fiscal quarter beginning with the first draw which occurred during the third quarter of 2021. The Medtronic Financing accrues interest at 5.0% per annum with accrued interest to be paid at maturity. The Company’s obligations under the Medtronic Financing are required to be guaranteed by all of its existing and future subsidiaries (other than certain excluded and immaterial subsidiaries). The Medtronic Financing may be prepaid in part or in full prior to maturity without any penalty or premium. Further, the Medtronic Financing may no longer be due and payable upon a termination in accordance with the Merger Agreement. The Company is subject to a number of affirmative and restrictive covenants pursuant to the Medtronic Financing, including covenants regarding compliance with applicable laws and regulations, maintenance of property, payment of taxes, maintenance of insurance, business combinations, incurrence of additional indebtedness and prepayments of other indebtedness and transactions with affiliates, among other covenants. The Company is also restricted from paying dividends or making other distributions or payments on its capital stock, subject to limited exceptions. The Medtronic Financing contains certain specified events of default, the occurrence of which would entitle Medtronic to immediately demand repayment of all outstanding principal and accrued interest on the Medtronic Financing. Such events of default include, among others, failure to make any payment under the Deerfield Loans when due, failure to observe or perform any covenant under the Medtronic Financing or the other transaction documents related thereto (subject in certain cases to specified cure periods), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgment levied against the Company, a material default by the Company under other indebtedness, and the occurrence of a change of control. As of December 31, 2021, the Company was in compliance with all covenants pertaining to the Medtronic Financing. As of December 31, 2021, the Medtronic Financing net carrying amount of $30.0 million was recorded within long-term debt on the consolidated balance sheets. The accrued interest associated with the Medtronic Financing was $0.2 million as of December 31, 2021 and recorded within other non-current liabilities on the consolidated balance sheets. The fair value of the Medtronic Financing approximates its carrying value as of December 31, 2021. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such amounts can be reasonably estimated. Indemnification The Company’s amended and restated certificate of incorporation contains provisions limiting the liability of directors, and its amended and restated bylaws provide that the Company will indemnify each of its directors to the fullest extent permitted under Delaware law. The Company’s amended and restated certificate of incorporation and amended and restated bylaws also provide its Board of Directors with discretion to indemnify its officers and employees when determined appropriate by the board. In addition, the Company has entered and expects to continue to enter into agreements to indemnify its directors and executive officers. Retention Bonus Program On September 1, 2021, the Compensation Committee of the Company’s Board of Directors approved the implementation of a retention program that covers substantially all employees of the Company. The program provides for the payment of up to $15.0 million, payable in cash. The timing and amounts of the payments related to this program will depend on the timing of the anticipated Merger and employees remaining active through the earning dates. The Company is currently recognizing program costs in its consolidated financial statements ratably over the period of service from September 1, 2021 through July 31, 2022. During the year ended December 31, 2021, total costs for the retention program we re $7.9 million. As of December 31, 2021, accrued retention bonuses payable of $7.9 million was presented in accrued compensation on the consolidated balance sheets. Litigation The Company may at times be involved in litigation and other legal claims in the ordinary course of business. When appropriate in the Company’s estimation, it may record reserves in its financial statements for pending litigation and other claims. Yaron vs. Intersect ENT, Inc. On May 15, 2019, a purported stockholder of the Company, Avi Yaron, filed a putative class action complaint in the United States District Court for the Northern District of California, entitled Yaron v. Intersect ENT, Inc., et al., Case No. 4:19-cv-02647, against the Company and certain individual officers and directors alleging violations of the Securities Exchange Act of 1934. The complaint alleges that the Company and the individual officers made false and/or misleading statements about the Company’s business and seeks unspecified damages and attorney’s fees. The Court appointed the lead plaintiff and set a schedule for initial motions and pleadings. By order dated June 19, 2020, the Court granted the Company’s motion to dismiss the amended complaint with leave to amend. On July 29, 2020, the plaintiff filed a second amended complaint. The Company moved to dismiss the second amended complaint on September 18, 2020. By order dated January 22, 2021, the Court granted the Company’s motion to dismiss the second amended complaint with leave to amend. Although the Company continues to believe this lawsuit is without merit, on March 4, 2021, the Company agreed with the plaintiff to a settlement-in-principle that, if approved, will resolve the litigation in its entirety. The settlement was approved and the Court entered a final judgment of dismissal on November 5, 2021. The deadline to file a notice of appeal with respect to the final judgment was December 6, 2021, and no such appeal was filed. During the year ended December 31, 2021, the Company funded an escrow account with its anticipated settlement costs associated with this lawsuit of $0.3 million. Stockholder Litigation Related to the Merger Beginning on September 1, 2021, seven civil actions were filed challenging the adequacy of certain public disclosures made by the Company concerning the Merger with Medtronic. On September 1, 2021, Elaine Wang, a purported stockholder of the Company, commenced an action in the United States District Court for the Southern District of New York, captioned Elaine Wang v. Intersect ENT, Inc., et al., Case No. 1:21-cv-7348, against the Company and current members of its Board of Directors (the “Wang Complaint”). On September 9, 2021, Marc Waterman, a purported stockholder of the Company, commenced an action in the United States District Court for the Southern District of New York, captioned Marc Waterman v. Intersect ENT, Inc., et al. , Case No. 1:21-cv-7552, against the Company and current members of its Board of Directors (the “Waterman Complaint”). On September 15, 2021, Carla Lawson, a purported stockholder of the Company, commenced an action in the United States District Court for the Northern District of California, captioned Carla Lawson v. Intersect ENT, Inc., et al. , Case No. 3:21-cv-7150, against the Company, five members of its current Board of Directors, and one former member of its Board of Directors (the “Lawson Complaint”). On September 22, 2021, Brian Jones, a purported stockholder of the Company, commenced an action in the United States District Court for the District of Delaware, captioned Brian Jones v. Intersect ENT, Inc., et al. , Case No. 1:21-cv-1339, against the Company and current members of its Board of Directors (the “Jones Complaint”). On September 23, 2021, two other purported stockholders of the Company filed lawsuits against the Company and current members of its Board of Directors: Richard Lawrence commenced an action in the United States District Court for the Northern District of California, captioned Richard Lawrence v. Intersect ENT, Inc. , et al., Case No. 3:21-cv-7405 (the “Lawrence Complaint”); and Alex Ciccotelli commenced an action in the United States District Court for the Eastern District of Pennsylvania, captioned Alex Ciccotelli v. Intersect ENT, Inc., et al. , Case 2:21-cv-4202 (the “Ciccotelli Complaint”). On September 29, 2021, Michael Kent, a purported stockholder of the Company, commenced an action in the United States District Court for the Southern District of New York, captioned Michael Kent v. Intersect ENT, Inc., et al. , Case No. 1:21-cv-8066, against the Company and current members of its Board of Directors (the “Kent Complaint,” collectively with the Wang Complaint, Waterman Complaint, Lawson Complaint, Jones Complaint, Lawrence Complaint, and Ciccotelli Complaint, the “Merger Complaints”). The Merger Complaints assert claims under Sections 14(a) and 20(a) of the Securities Exchange Act of 1934 and seek, among other things, an injunction preventing consummation of the proposed transaction with Medtronic, rescission of the proposed transaction or rescissory damages in the event it is consummated, declaratory relief, an accounting by the defendants for all damages caused to the plaintiffs, and the award of attorneys’ fees and expenses. The Company believes the claims asserted in the Merger Complaints are without merit and denies any wrongdoing in connection with the statements made by the Company concerning the Merger with Medtronic. However, as set forth below, the Merger Complaints have all been dismissed: • On October 1, 2021, Elaine Wang dismissed the Wang Complaint with prejudice; • On October 5, 2021, Michael Kent dismissed the Kent Complaint without prejudice; • On October 7, 2021, Brian Jones dismissed the Jones Complaint without prejudice; • On October 12, 2021, Marc Waterman dismissed the Waterman Complaint without prejudice, and Alex Ciccotelli dismissed the Ciccotelli Complaint without prejudice; and • On October 13, 2021, Carla Lawson dismissed the Lawson Complaint without prejudice, and Richard Lawrence dismissed the Lawrence Complaint without prejudice. Additional lawsuits may be filed against the Company or its directors and offers in connection with the Merger. Defending such lawsuits could require the Company to incur significant costs and divert the attention of management. Such legal proceedings could delay or prevent the closing of the Merger from occurring within the contemplated timeframe. The Company cannot predict the outcome of any lawsuit that might be filed subsequent to the date of filing this Annual Report on Form 10-K and cannot reasonably estimate the possible losses with respect to these matters. Patent Matters In 2020, the Company was notified of potential infringement of patents held by a competitor associated with its sale of VenSure balloons. After the announcement of the anticipated Merger with Medtronic in the third quarter of 2021, communications regarding this matter continued. Although the Company believes this assertion is without merit and believes it would have a favorable result if the claim were to proceed to litigation, the Company continued with business and licensing discussions with the competitor late in 2021. During the year ended December 31, 2021, total potential royalty costs accrued were less than $0.2 million. Based on subsequent discussions, the Company believes it is probable the assertion will not proceed to litigation and expects there will be a settlement resulting in a material liability, nearly all of which would represent a prepayment of royalty on future sales of VenSure balloons and which would be attributed to the Fiagon business which is held for sale (see Note 8). Additionally, timing of any potential payments related to this matter are expected to be contingent on the timing of the anticipated Merger with Medtronic. Purchase Commitments As of December 31, 2021, the Company had non-cancellable commitments to vendors totaling $12.0 million . |
Employee Retirement Plan
Employee Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Employee Retirement Plan | Employee Retirement Plan In January 2007, the Company established a qualified retirement plan under section 401(k) of the Internal Revenue Code (“IRC”) under which participants may contribute up to 100% of their eligible compensation, subject to maximum deferral limits specified by the IRC. The Company may make a discretionary profit sharing contribution to each eligible employee, subject to limits specified by the IRC, on an annual basis, provided the employee is employed with the Company on the last day of the plan year which is December 31. In addition, the Company may also make matching contributions of an employee’s eligible compensation. The Company’s contributions will vest 25% per year over four years. Total matching contributions were $1.1 million , $1.0 million and $1.1 million during the years ended December 31, 2021, 2020 and 2019, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The following table presents domestic and foreign components of loss before income taxes for the periods presented (in thousands): Year Ended 2021 2020 2019 Domestic $ (93,593) $ (70,801) $ (42,994) Foreign (67,732) (1,934) — $ (161,325) $ (72,735) $ (42,994) Income taxes is composed of the following (in thousands): Year Ended 2021 2020 2019 Current: Federal $ — $ — $ — State — — — Foreign 110 20 — Total current 110 20 — Deferred: Federal — — — State — — — Foreign (1,800) (436) — Total deferred (1,800) (436) — Income tax (benefit) $ (1,690) $ (416) $ — The amount computed by applying the federal statutory rate to loss before income taxes reconciles to the provision for income taxes is as follows (in thousands): Year Ended 2021 2020 2019 Tax at federal statutory rate $ (33,878) $ (15,274) $ (9,029) State tax, net of federal benefit (5,650) (2,881) (1,977) Effect of foreign operations (7,591) (10) — Permanent items 3,698 234 299 Stock-based compensation 1,952 2,079 190 R&D tax credit (549) (282) (782) Change in valuation allowance 40,328 15,718 11,299 $ (1,690) $ (416) $ — For the year ended December 31, 2021, $2.8 million of the permanent items reconciling difference above related to the Company’s embedded derivatives on its Convertible Notes. Significant components of net deferred tax liabilities are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating losses $ 103,431 $ 73,711 R&D tax credit 10,427 9,538 Accruals and other 13,095 8,671 Operating lease liabilities 4,303 4,695 Depreciation and amortization 402 — 131,658 96,615 Deferred tax liabilities: Depreciation and amortization — (6,257) Operating lease right-of-use assets (3,759) (4,356) (3,759) (10,613) Net deferred tax assets: 127,899 86,002 Valuation allowance (127,899) (87,571) Net deferred tax liability $ — $ (1,569) Deferred income taxes reflect the tax effects of net operating loss carry forwards (“NOLs”) and tax credit carryforwards and the net temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. In connection with the acquisition of Fiagon on October 2, 2020, a net deferred tax liability of $2.2 million was established, the most significant component of which is related to the book to tax basis differences associated with the acquired developed technology and customer relationships, as well as acquired NOLs. The intangible assets were subsequently impaired during the year ended December 31, 2021 and the entire balance was written off. Realization of the deferred tax assets is dependent upon the generation of future taxable income, if any, the amount and timing of which are uncertain. Based on available objective evidence, management believes it is more likely than not that the deferred tax assets are not recognizable and will not be recognizable until the Company has sufficient taxable income. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $40.3 million and $15.8 million during the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, the Company’s federal NOL carryforwards were $318.8 million, of which $148.4 million will begin to expire in 2026, and $170.4 million have an indefinite carryforward period. Federal research and development tax credits of $7.5 million will begin to expire in 2026. In addition, NOL carryforwards for state income tax purposes of $71.6 million will begin to expire in 2028 and state research and development tax credits of $7.0 million do not expire. Fiagon also had foreign net operating loss carryforwards of $18.4 million in Germany, which may be carried forward indefinitely. Utilization of the NOL carryforwards may be subject to an annual limitation due to the ownership change limitations provided by the Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the expiration of the NOL before utilization. The Company had unrecognized tax benefits of $2.9 million and $2.7 million as of December 31, 2021 and 2020, respectively, associated with domestic taxes. Due to the Company’s full valuation allowance against all domestic net deferred tax assets, the Company’s unrecognized tax benefits, if recognized, would not affect the effective tax rate. A reconciliation of the change in the unrecognized tax benefit during the year is as follows (in thousands): December 31, 2021 2020 2019 Beginning of year $ 2,654 $ 2,485 $ 2,107 Additions for tax positions related to: Current year 245 169 378 Prior years — — — End of year $ 2,899 $ 2,654 $ 2,485 The Company does not expect a significant change to its unrecognized tax benefits over the next twelve months. The unrecognized tax benefit may increase or decrease during the next twelve months for items that arise in the ordinary course of business. The Company files income tax returns in the U.S. federal and various state jurisdictions. Tax years beginning in 2004 through 2021 remain open to examination by the major taxing authorities to which the Company is subject. In the Company’s foreign jurisdiction, Germany, the tax years subsequent to 2014 remain open to examination. The Company’s policy is to record interest related to uncertain tax positions as interest expense and any penalties within other income (expense), net in its consolidated statements of operations and comprehensive loss. The Company has not recorded any interest expense or penalties associated with unrecognized tax benefits. |
Assets and Liabilities Held for
Assets and Liabilities Held for Sale | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Assets and Liabilities Held for Sale | Assets and Liabilities Held for Sale During the year ended December 31, 2021, in connection with the announcement of the anticipated Merger with Medtronic and with respect to antitrust considerations, t he Company committed to a plan for the sale of Fiagon and concluded that as of December 31, 2021, Fiagon met all of the held for sale criteria. The Company’s management does not consider this to be a strategic shift that will have a major effect on the Company’s operations and financial results, and therefore does not qualify for reporting as a discontinued operation. During the year ended December 31, 2021, the Company recognized an impairment loss of $67.8 million in the consolidated statements of operations and comprehensive loss to adjust the carrying value of the disposal group to fair value less costs to sell. The impairment is a result of the circumstances surrounding the pending transaction with Medtronic, which have led to a plan to sell that is outside of the normal course of business in terms of timing and value expectations. The following table summarizes the carrying values of the assets and liabilities classified as held for sale as of December 31, 2021 (in thousands): December 31, 2021 Assets held for sale Cash and cash equivalents $ 558 Accounts receivable, net 1,260 Inventories, net 2,166 Prepaid expenses and other current assets 1,279 Property and equipment, net — Operating lease right-of-use assets — Intangible assets, net — Goodwill — Restricted cash 90 Total assets held for sale 5,353 Liabilities held for sale Accounts payable 1,311 Accrued compensation 2,421 Other current liabilities 1,400 Operating lease liabilities 221 Total liabilities held for sale 5,353 Net assets held for sale $ — |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of preparation | Basis of Preparation The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). These consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation. |
Risk and uncertainties | Risks and Uncertainties The Company is subject to risks and uncertainties resulting from the COVID-19 pandemic. The Company cannot predict the extent or duration of the impact of the COVID-19 pandemic on its financial and operating results, as the information regarding the current environment is evolving. Due to the COVID-19 pandemic, the Company’s business has been and will continue to be impacted by patients’ decisions whether or not to undergo sinus surgeries and, as a result, ENT ASC and office procedure volumes may fluctuate. The Company’s operations may be further impacted by COVID-19 due to changes in our manufacturing operations as a result of any future regulations or guidance issued by local and federal authorities. Furthermore, the COVID-19 pandemic has led to severe disruption and volatility in global capital markets and increased economic uncertainty and instability. The magnitude of the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to: the duration and severity of the pandemic is unknown and could continue longer, and be more severe, than the Company currently expects; the duration, extent and re-occurrence of restrictions impacting its manufacturing operations; the unknown state of the U.S. economy following the pandemic; the level of demand for the Company’s products as the pandemic subsides; and the time it will take for the economy to recover from the pandemic. As of the date of these consolidated financial statements, the extent to which the COVID-19 pandemic may materially adversely impact the Company’s financial results, operating results, or liquidity is uncertain. |
Use of estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its revenue related allowances, inventory, common stock valuation and related stock-based compensation, leases, business combinations, embedded derivatives, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. |
Concentration of credit risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash equivalents, short-term investments and accounts receivable. The Company believes that the credit risk in its accounts receivable is mitigated by its credit evaluation process, relatively short collection terms and diversity of its customer base. The Company generally does not require collateral and losses on accounts receivable have historically been within management’s expectations. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies, and institutions with investment-grade credit ratings, as well as corporate debt or commercial paper issued by the highest quality financial and non-financial companies, and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents and issuers of investments to the extent recorded on the balance sheets. The Company has limited its credit risk associated with cash, cash equivalents and short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated investments. |
Cash, cash equivalents, and restricted cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid securities, readily convertible to cash, that mature within 90 days or less from the date of purchase to be cash equivalents. |
Short-term investments | Short-term Investments Short-term investments, which are classified as available-for-sale, represent highly liquid debt instruments with maturities greater than 90 days at date of purchase. Such investments are recorded at fair value and unrealized holding gains and losses are reported as a separate component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit) until realized. The Company reviews its investment portfolio periodically to assess for other-than-temporary impairment. Should the Company determine that any unrealized losses on the investments are other-than-temporary, the amount of that impairment to be recognized in earnings will depend on whether the Company intends to sell the security or more likely than not will be required to sell the security before recovery of its amortized cost basis less any current period credit loss. Refer to the credit losses accounting policy for further discussion. The specific identification method is used to determine the cost of securities disposed of, with realized gains and losses reflected other income (expense), net in the consolidated statements of operations and comprehensive loss. |
Inventories | Inventories Inventories are valued at the lower of cost, computed on a first-in, first-out basis, or net realizable value. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of facility expense, freight, handling costs, and consumption are expensed as incurred, and not included in allocable overhead. The Company maintains provisions for excess and obsolete inventory based on its estimates of forecasted demand and, where applicable, product expiration. |
Property and equipment | Property and EquipmentProperty and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally two |
Implementation Costs in a Cloud Computing Arrangement | Implementation Costs in a Cloud Computing ArrangementThe Company capitalizes qualified implementation costs incurred in a hosting arrangement that is a service contract for which it is the customer in accordance with the requirements for capitalizing costs incurred to develop internal-use software. These capitalized implementation costs are recorded within prepaid and other current assets or other non-current assets, and are generally amortized over the fixed, non-cancellable term of the associated hosting arrangement on a straight-line basis. |
Impairment of long-lived assets | Impairment of Long-lived AssetsLong-lived assets consist primarily of property and equipment and definite-lived intangible assets and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require that a long-lived asset be tested for possible impairment, the Company compares the undiscounted cash flows expected to be generated, performed at the lowest level of identifiable cash flows, which is at the individual asset level or at the asset group level, to the carrying value of the related asset or asset group. If the carrying amount of the long-lived asset is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying amount exceeds its fair value. The Company determines fair value using the income approach based on the present value of expected future cash flows or other appropriate measures of estimated fair value. The Company’s cash flow assumptions consider historical and forecasted revenue and operating costs and other relevant factors. |
Leases | Leases For agreements with a term of more than twelve months, the Company determines if an agreement is a lease at inception. Operating lease liabilities represent an obligation to make lease payments arising from the lease agreement. Operating lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the remaining lease term. In determining the present value of lease payments, the Company estimates its incremental borrowing rate as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, of an amount equal to the lease payments in a similar economic environment. Operating lease liabilities are classified as other current and non-current liabilities on our consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and are classified as other non-current assets. Lease expense is recognized on a straight-line basis over the expected lease term. |
Embedded derivatives related to convertible debt instruments | Embedded Derivatives Related to Convertible Debt Instruments During 2020, the Company issued convertible debt with embedded derivatives that are required to be bifurcated from their host contract and remeasured to fair value at each balance sheet date. Any resulting gain or loss related to the change in the fair value of the embedded derivative is being recorded to other income (expense), net in the consolidated statements of operations and comprehensive loss. Changes in the Company’s assumptions, such as the estimated probability of triggering events and other inputs to the valuation of the embedded derivatives, such as the Company’s stock price, could result in material changes in the valuation in future periods. |
Business Combinations | Business Combinations Business combinations are accounted for using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company’s consolidated financial statements. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Deferred acquisition related consideration incurred in connection with a business combination is recorded at its present value upon the acquisition, with any resulting accretion expense recorded as interest expense in the consolidated statements of operations and comprehensive loss. |
Assets held for sale | Assets Held for Sale The Company considers assets to be held for sale when management approves and commits to a plan to dispose of an asset or disposal group. Assets or disposal groups held for sale are recorded initially at the lower of carrying value or estimated fair value, less estimated costs to sell, and adjusted quarterly. Any initial loss and quarterly changes are limited to the carrying value at the date of held for sale classification and are reflected in impairment on assets held for sale in the consolidated statements of operations and comprehensive loss. Upon designation as an asset held for sale or disposal group, the Company stops recording depreciation and amortization expense on such assets. Costs to sell a disposal group include incremental direct costs to transact the sale and represent the costs that result directly from and are essential to a sale transaction that would not have been incurred by the entity had the decision to sell not been made. To the extent that there are losses in excess of the carrying value as of the date of held for sale classification of the assets or disposal group, the losses are recognized upon the date of sale. |
Goodwill and acquired intangible assets | Goodwill and Acquired Intangible Assets Goodwill represents the excess of the purchase price over the fair value of net identifiable assets and liabilities and is allocated to reporting units on a relative fair value basis. Goodwill is not amortized but is tested for impairment at least annually during the third quarter, or if circumstances indicate their value may no longer be recoverable. The Company operates in two segments and has combined them into a single reportable segment as one of them is insignificant and has a majority of economic characteristics that are similar in nature to the other. Intangible assets acquired in a business combination are recorded at fair value. Identifiable finite-lived intangible assets are amortized over the period of estimated benefit on a straight-line basis, reflecting the pattern of economic benefits associated with these assets. The estimated useful lives of the Company’s finite-lived intangible assets generally range from three |
Revenue recognition | Revenue Recognition The Company recognizes revenue when its customer obtains control of promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. To determine revenue recognition for arrangements that the Company determines are within the scope of Accounting Standards Codification Topic 606: Revenue from Contracts with Customers (“Topic 606”), the Company performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies the performance obligations. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The contracts are typically in the form of a purchase order from the customer. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied. The Company’s typical payment terms are between approximately 30 to 90 days. The Company expenses shipping and handling costs as incurred and includes them in the cost of sales. In those cases where shipping and handling costs are billed to customers, the Company classifies the amounts billed as a component of revenue. Taxes collected from customers and remitted to governmental authorities are excluded from revenues. The Company expenses any incremental costs of obtaining a contract as and when incurred as the expected amortization period of the incremental costs would have been less than one year. The PROPEL family of products are regulated by the FDA as medical devices. The Company recognizes revenue through sales of its PROPEL family of products to hospitals and ASC located almost entirely in the United States when control of the product is transferred to the customer, typically upon shipment of goods to the customer, satisfying the Company’s only performance obligation. The FDA has approved SINUVA as a drug and it is therefore regulated as such. The Company sells SINUVA to a limited number of specialty pharmacies and specialty distributors in the United States, (“Resellers”). These Resellers subsequently sell SINUVA to health care providers. Revenue from SINUVA sales are recognized when control of the product is transferred to the Resellers, typically upon receipt of goods by the Reseller, satisfying the Company’s only performance obligation. The Company recognizes Reseller fees, prompt pay discounts, product sales discounts, rebates, returns and other allowances as an estimated reduction of revenue in the same period the related revenue is recognized. In addition to the agreements with the Resellers, the Company enters into arrangements with governmental agencies that result in rebates, chargebacks and discounts with respect to the purchase of SINUVA. These amounts may include Medicaid and Tricare rebates, chargebacks related to Federal Supply Schedule of the General Services Administration, Distribution and Pricing Agreement with the Department of Defense and 340B of the Public Health Service Act as well as other allowances that may be offered within contracts between the Company and its direct or indirect customers relating to the Company’s sales of SINUVA, collectively referred to as “Discounts and Rebates.” Discounts and Rebates are based on amounts owed or expected to be owed on the related sales. These estimates take into consideration the Company’s historical experience, the remaining shelf life of the product, current contractual and statutory requirements, specific known market events and trends and industry data. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect revenue and earnings in the period such variances become known. On the consolidated balance sheets, such amounts are generally classified as reductions |
Multiple-Element Arrangements | Multiple-Element ArrangementsThe Company may, from time to time, enter into lease arrangements with certain qualified customers in connection with commitments to purchase consumable products to accompany the use of the equipment. Leases have terms that generally range from 24 to 48 months and are usually collateralized by a security interest in the underlying assets. For all periods presented, revenue from these arrangements was not material. |
Cost of sales | Cost of Sales Cost of sales consists primarily of manufacturing overhead costs, material costs, and direct labor. A significant portion of the Company’s cost of sales consists of manufacturing overhead costs. These overhead costs include compensation, including stock-based compensation and other operating expenses associated with the cost of quality assurance, material procurement, inventory control, facilities, information technology, equipment and operations supervision and manufacturing and warehouse management. Cost of sales also includes depreciation expense for production equipment, amortization of intangible assets associated with acquired product technologies and processes, maintenance of operational processes, and certain direct costs such as shipping costs. |
Research and development | Research and Development Research and development expenses consist primarily of product development, clinical and regulatory affairs, consulting services and other costs associated with products and technologies in development. These expenses include employee compensation, including stock-based compensation, supplies, quality assurance and related travel and allocated facilities and information technology expenses. Clinical expenses include clinical trial design, clinical site reimbursement, data management and travel expenses, and the cost of manufacturing products for clinical trials. |
Foreign currency | Foreign Currency The functional currency of the Company’s wholly-owned subsidiaries is the U.S. dollar. When the transactional currency is different than the functional currency, transaction gains and losses are included as a component of other income (expense), net. Monetary assets and liabilities denominated in foreign currencies are remeasured at exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are measured at rates in effect on the dates the assets were acquired or liabilities were assumed. Revenues and expenses related to monetary items are measured at rates of exchange prevailing on the transaction dates, while expenses relating to non-monetary items are measured at historical rates. Gains and losses on remeasurement are reflected in other income (expense), net when incurred. In November 2020, the Company entered into foreign currency forward contracts as economic hedges to protect against volatility of foreign exchange rate exposure of its deferred acquisition consideration liabilities, which are stated in Euros. The forward contracts are not designated for hedge accounting and are remeasured at fair value with gains or losses reported in other income (expense), net. |
Credit losses | Credit LossesThe Company is exposed to credit losses primarily through receivables from customers and distribution partners and through its available-for-sale debt securities. The Company’s expected loss allowance methodology for the receivables is developed using historical collection experience, current and future economic market conditions, a review of the current aging status, and the financial condition of its customers and distribution partners. Specific allowance amounts are established to record the appropriate allowance for customers that have an identified specific risk of default. General allowance amounts are established based upon the Company’s assessment of expected credit losses for its receivables by aging category. Balances are written off when they are ultimately determined to be uncollectible. The Company’s expected loss allowance methodology for the debt securities is developed by reviewing the extent of the unrealized loss, the size, term, geographical location, industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. |
Stock-based compensation | Stock-based Compensation The Company maintains equity incentive plans to provide long-term incentives for employees and members of the Board of Directors. The plans allow for the issuance of non-statutory and incentive stock options and restricted stock units to employees and non-statutory stock options to non-employee directors. The Company is required to determine the fair value of equity incentive awards and recognize compensation expense for all equity incentive awards made to employees and directors, including employee stock options and restricted stock units. Stock-based compensation expense is recognized over the requisite service period in the consolidated statements of operations and comprehensive loss. The Company uses the straight-line method for expense attribution for awards with service-based conditions only, and uses an accelerated attribution method for awards with performance and market conditions. The Company has elected to account for forfeitures when they occur. The valuation model used for calculating the fair value of awards for stock-based compensation expense, except for market-based awards, is the Black-Scholes option-pricing model (the “Black-Scholes model”). For market-based awards, the Monte Carlo simulation model (the “Monte Carlo simulation”) is used. Both the Black-Scholes model and Monte Carlo simulation require the Company to make assumptions and judgments about the variables used in the calculation, including the expected term (weighted average period of time that the awards granted are expected to be outstanding), the volatility of the Company’s common stock and an assumed risk-free interest rate. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected term of the option. |
Advertising expenses | Advertising ExpensesThe Company expenses the costs of advertising, including promotional expenses, as incurred. |
Income taxes | Income Taxes The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. Valuation allowances against deferred tax assets are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company’s policy is to record interest related to uncertain tax positions within interest expense and any penalties within other income (expense), net in the consolidated statement of operations and comprehensive loss. |
Net loss per share | Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and common stock equivalent shares from dilutive stock options, employee stock purchases and restricted stock units outstanding during the period, as well as stock issuable upon the conversion of the Convertible Notes. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods as all potentially dilutive securities were antidilutive in those periods. The Company uses the if-converted method for calculating any potential dilutive effects of the Convertible Notes. The Company did not adjust the net losses for the years ended December 31, 2021 and 2020 to eliminate any interest expense related to the Convertible Notes (see Note 11) in the computation of diluted loss per share, or calculate the potential common shares from conversion, as the effects would have been anti-dilutive. The shares presented above represent the maximum number of convertible shares which can be issued subject to the make-whole increase to the conversion rate upon certain events. |
Comprehensive loss | Comprehensive Loss Comprehensive loss consists of net loss and changes in unrealized gains and losses on short-term investments. |
Segment, geographical and customer concentration | Segment, Geographical and Customer Concentration The Company operates in two segments and has combined them into a single reportable segment as one of them is insignificant and has a majority of economic characteristics that are similar in nature to the other. The Company’s long-lived tangible assets and revenue are predominantly based in the United States. No single customer accounted for more than 10% of revenue during the years ended December 31, 2021, 2020 and 2019, and no single customer accounted for more than 10% of accounts receivable as of December 31, 2021 and 2020. |
Accounting pronouncements | Accounting Pronouncements Recently Adopted Accounting Standards In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. ASU 2019-12 became effective for the Company beginning in 2021. The adoption of the standard did not result in a material impact to the Company’s consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt- Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) . ASU 2020-06 modifies and simplifies accounting for convertible instruments. The new guidance eliminates certain separation models that require separating embedded conversion features from convertible instruments. ASU 2020-06 also addresses how convertible instruments are accounted for in the diluted earnings per share calculation. The Company early adopted this standard and became effective beginning in 2021. The adoption of the standard had no impact to the Company’s consolidated financial statements. In October 2020, the FASB issued ASU No. 2020-08, Codification Improvements to Subtopic 310-20, Receivables- Nonrefundable Fees and Other Costs (“ASU 2020-08”). ASU 2020-08 clarifies the accounting for the amortization period for certain purchased callable debt securities held at a premium by giving consideration to securities which have multiple call dates. ASU 2020-08 became effective for the Company beginning in 2021. The adoption of the standard had no impact to the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of cash, cash equivalents, and restricted cash | The following table summarizes the Company’s cash, cash equivalents, and restricted cash as of December 31, 2021 and 2020 (in thousands): December 31, 2021 2020 Cash and cash equivalents $ 38,397 $ 13,521 Restricted cash 17,887 17,500 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 56,284 $ 31,021 |
Schedule of cash, cash equivalents, and restricted cash | The following table summarizes the Company’s cash, cash equivalents, and restricted cash as of December 31, 2021 and 2020 (in thousands): December 31, 2021 2020 Cash and cash equivalents $ 38,397 $ 13,521 Restricted cash 17,887 17,500 Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows $ 56,284 $ 31,021 |
Schedule of potentially dilutive securities outstanding excluded from diluted weighted average shares outstanding | The following potentially dilutive securities outstanding have been excluded from the computations of weighted average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): Year Ended 2021 2020 2019 Common stock options 2,930 3,172 3,209 Market-based performance stock options 427 427 427 Restricted stock units 528 488 511 Market-based performance stock units 269 130 89 Employee stock purchase plan shares — 63 70 Stock issuable upon conversion of convertible notes 6,309 6,309 — 10,463 10,589 4,306 |
Composition of Certain Financ_2
Composition of Certain Financial Statement Items (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Accounts Receivable | Accounts Receivable, net (in thousands): December 31, 2021 2020 Accounts receivable $ 17,948 $ 15,079 Allowance for doubtful accounts (622) (487) $ 17,326 $ 14,592 The reserve for credit losses on accounts receivable for the years ended December 31, 2021, 2020, and 2019 were as follows (in thousands): Year Ended December 31, 2021 2020 2019 Beginning $ 487 $ 131 $ 80 Additions from acquisition — 175 — Charges, net of recoveries 332 221 94 Write-offs (140) (40) (43) Reclassification to held for sale (57) — — Ending $ 622 $ 487 $ 131 |
Components of Inventory | Inventories, net (in thousands): December 31, 2021 2020 Raw materials $ 3,122 $ 2,865 Work-in-process 4,113 3,411 Finished goods 11,364 5,778 $ 18,599 $ 12,054 |
Property and Equipment | Property and Equipment, net (in thousands): December 31, 2021 2020 Computer equipment and software $ 2,370 $ 2,159 Furniture and office equipment 1,598 1,611 Laboratory and manufacturing equipment 8,057 8,939 Leasehold improvements 4,103 3,385 16,128 16,094 Less: accumulated depreciation and amortization (11,133) (10,470) $ 4,995 $ 5,624 |
Disaggregation of Revenue | The following table disaggregates our product sales by product (in thousands): Year Ended December 31, 2021 2020 2019 PROPEL family of products $ 91,117 $ 74,335 $ 104,657 SINUVA 9,074 5,315 4,485 VenSure, CUBE, and accessories 6,557 904 — $ 106,748 $ 80,554 $ 109,142 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Cash, Cash Equivalents and Available-for-Sale Investments Measured at Fair Value on Recurring Basis | The following is a summary of the Company’s unrealized gains and losses related to its cash, cash equivalents, and short-term investments in marketable securities designated available-for-sale (in thousands): Reported as: Amortized Gross Unrealized Estimated Cash and cash Short-term December 31, 2021 Gains Losses Level 1: Cash $ 9,101 $ — $ — $ 9,101 $ 9,101 $ — Money market funds 29,296 — — 29,296 29,296 — 38,397 — — 38,397 38,397 — Level 2: U.S. treasury bills 7,080 — (5) 7,075 — 7,075 Corporate debt securities 9,557 — (5) 9,552 — 9,552 Commercial paper 5,991 — — 5,991 — 5,991 22,628 — (10) 22,618 — 22,618 $ 61,025 $ — $ (10) $ 61,015 $ 38,397 $ 22,618 Reported as: Amortized Gross Unrealized Estimated Cash and cash Short-term December 31, 2020 Gains Losses Level 1: Cash $ 9,755 $ — $ — $ 9,755 $ 9,755 $ — Money market funds 2,762 — — 2,762 2,762 — 12,517 — — 12,517 12,517 — Level 2: U.S. treasury bills 49,698 4 (3) 49,699 1,004 48,695 Corporate debt securities 6,307 — (2) 6,305 — 6,305 U.S. government agency bonds 19,504 3 (1) 19,506 — 19,506 75,509 7 (6) 75,510 1,004 74,506 $ 88,026 $ 7 $ (6) $ 88,027 $ 13,521 $ 74,506 |
Investments Classified by Contractual Maturity Date | The following table summarizes the contractual maturity of the Company’s cash equivalents and short-term investments as of December 31, 2021 (excluding cash and money-market funds): Amortized Cost Fair Value Maturity in less than one year $ 19,617 $ 19,609 Maturity in one to five years 3,011 3,009 Total $ 22,628 $ 22,618 |
Summary of Changes in the Fair Value of Derivative Liabilities | Changes in the fair value of the Company’s Level 3 liabilities were as follows (in thousands): December 31, Balance as of December 31, 2019 $ — Additions 1,800 Fair value adjustment 1,248 Balance as of December 31, 2020 3,048 Additions — Fair value adjustment 13,138 Balance as of December 31, 2021 $ 16,186 |
Derivative Instruments and Hedg
Derivative Instruments and Hedging Activities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Schedule of Derivative Instruments | The Company had gross notional amounts (in EUR) with USD equivalents of $36.9 million and $55.0 million on foreign currency exchange contracts not designated as hedging instruments outstanding as of December 31, 2021 and 2020 as follows (in thousands): Year Ended December 31, 2021 2020 Notional amounts: Forward contracts €30,000 €45,000 Gross fair value recorded in: Prepaid expenses and other current assets $ — $ 275 Other non-current assets $ — $ 558 Other current liabilities $ 1,141 $ — Other non-current liabilities $ 1,070 $ — |
Derivatives Not Designated as Hedging Instruments | The following table summarizes the effect of the Company’s foreign currency exchange contracts on its consolidated statements of operations and comprehensive loss recognized in other income (expense), net (in thousands): Year Ended December 31, 2021 2020 Recognized gains (losses) on foreign currency exchange contracts $ (3,045) $ 833 Foreign exchange gains (losses) on remeasurement of deferred acquisition related consideration $ 3,785 $ (2,388) |
Business Combinations (Tables)
Business Combinations (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Pro Forma Information | The following unaudited pro forma condensed combined financial information gives effect to the acquisition of Fiagon as if it was consummated on January 1, 2019 (the beginning of the comparable reporting period), and includes pro forma adjustments including interest expense, cost of sales, foreign exchange and imputed interest impacts of the deferred consideration, amortization of intangibles, and direct and incremental transaction costs reflected in the historical financial statements. Specifically, the following adjustments were made: • For the year ended December 31, 2020, the Company increased interest expense by $0.8 million, increased other expense from foreign currency remeasurement by $1.5 million, and reduced selling, general and administrative expenses by $0.6 million. • For the year ended December 31, 2019, the Company increased cost of sales by $0.6 million, increased selling, general and administrative expenses by $6.5 million, including $4.0 million related to non-recurring acquisition and integration costs, increased interest expense by $1.9 million, and increased other income by $1.2 million from foreign currency remeasurement. Year Ended December 31, 2020 2019 (Unaudited, in thousands) Revenue $ 82,797 $ 120,998 Net loss (77,504) (50,707) Net loss per share, basic and diluted (2.38) (1.62) |
Schedule of Finite-Lived Intangible Assets | The following table summarizes the components of gross intangible asset, accumulated amortization, and net intangible asset balances as of December 31, 2020 (in thousands): December 31, Gross Carrying Amount Accumulated Amortization Net Carrying Amount Developed technology $ 19,100 $ (478) $ 18,622 Distribution network 1,100 (92) 1,008 Customer relationships 1,500 (125) 1,375 Trademarks 200 (12) 188 Total intangible assets $ 21,900 $ (707) $ 21,193 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Operating Lease Liabilities | Operating lease liabilities (in thousands): December 31, 2021 2020 Current portion presented in other current liabilities $ 1,975 $ 762 Non-current portion presented in operating lease liabilities 14,709 17,736 $ 16,684 $ 18,498 |
Lessee, Operating Lease, Liability, Maturity | Future minimum annual operating lease payments are as follows (in thousands): Years Ending December 31, December 31, 2021 2022 $ 3,645 2023 4,088 2024 4,126 2025 4,058 2026 4,200 Thereafter 4,347 Total minimum payments 24,464 Less: present value adjustment (5,931) Less: tenant improvement allowance (1,849) Total $ 16,684 |
Assets And Liabilities, Lessee | December 31, 2021 2020 Weighted-average remaining lease term (years) 5.9 6.8 Weighted-average discount rate 9.5 % 9.5 % |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following is a summary of the Company’s stock option activity and related information (options in thousands): Year Ended Options Weighted Average Outstanding, beginning of period 3,599 $ 22.01 Granted 943 22.52 Exercised (388) 14.63 Forfeited (797) 25.33 Outstanding, end of period 3,357 22.22 Exercisable 1,574 23.22 |
Summary of Restricted Stock Units Activity | The following is a summary of the Company’s RSU activity and related information (RSUs in thousands): Year Ended RSUs Weighted Average Outstanding, beginning of period 488 $ 23.88 Awarded 385 23.40 Vested (210) 24.10 Forfeited (135) 23.33 Outstanding, end of period 528 23.58 |
Summary of Performance Stock Units Activity | The Company has granted Performance Stock Units (“PSUs”), which are subject to service, performance, and market-based vesting conditions. The following is a summary of the Company’s PSU activity and related information (PSUs in thousands): Year Ended PSUs Weighted Average Outstanding, beginning of period 130 $ 15.94 Awarded 188 24.99 Forfeited (49) 21.93 Outstanding, end of period 269 21.16 |
Stock-based Compensation Expe_2
Stock-based Compensation Expense (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Based Compensation Expense | Total stock-based compensation expense recognized is as follows (in thousands): Year Ended 2021 2020 2019 Cost of sales $ 1,543 $ 1,805 $ 1,273 Selling, general and administrative 12,901 11,493 15,709 Research and development 2,012 1,660 3,167 $ 16,456 $ 14,958 $ 20,149 |
Summary of Weighted Average Assumptions Used to Estimate Options Using Black-Scholes Model | The fair value of options granted to employees or directors during the periods presented below were estimated as of the grant date using the Black-Scholes model assuming the weighted average assumptions listed in the following table: Year Ended 2021 2020 2019 Expected term (years) 6.0 6.0 6.0 Expected volatility 66.0 % 58.0 % 48.0 % Risk-free interest rate 0.7 % 0.9 % 2.2 % Dividend yield 0.0 % 0.0 % 0.0 % Fair value $ 13.29 $ 10.87 $ 11.74 |
Summary of Weighted Average Assumptions Used to Estimate ESPP Using Black-Scholes Model | The fair value of stock purchase rights granted under the 2014 ESPP to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted average assumptions listed in the following table: Year Ended 2021 2020 2019 Expected term (years) 0.5 0.5 0.5 Expected volatility 52.0 % 82.0 % 49.0 % Risk-free interest rate 0.0 % 0.1 % 2.0 % Dividend yield 0.0 % 0.0 % 0.0 % Fair value $ 5.29 $ 5.67 $ 6.71 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Net Carrying Amount of the Convertible Notes | As of December 31, 2021 and 2020, the net carrying amount of the Convertible Notes recorded within long-term debt on the consolidated balance sheets was as follows (in thousands): December 31, 2021 2020 Outstanding principal amount of convertible notes $ 65,000 $ 65,000 Unamortized debt discount and transaction costs (3,485) (4,398) Fair value of embedded derivatives 16,186 3,048 Convertible notes, net $ 77,701 $ 63,650 |
Schedule of Long-term Debt Instruments | As of December 31, 2021, the net carrying amount of the Deerfield Loans recorded within long-term debt on the consolidated balance sheets was as follows: December 31, Outstanding principal amount of loans $ 20,000 Unamortized debt discount and transaction costs (387) Accrued exit fee 31 Deerfield loans, net $ 19,644 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Federal Statutory Rate to Loss Before Income Taxes Reconciles to Provision for Income Taxes | The following table presents domestic and foreign components of loss before income taxes for the periods presented (in thousands): Year Ended 2021 2020 2019 Domestic $ (93,593) $ (70,801) $ (42,994) Foreign (67,732) (1,934) — $ (161,325) $ (72,735) $ (42,994) Year Ended 2021 2020 2019 Current: Federal $ — $ — $ — State — — — Foreign 110 20 — Total current 110 20 — Deferred: Federal — — — State — — — Foreign (1,800) (436) — Total deferred (1,800) (436) — Income tax (benefit) $ (1,690) $ (416) $ — The amount computed by applying the federal statutory rate to loss before income taxes reconciles to the provision for income taxes is as follows (in thousands): Year Ended 2021 2020 2019 Tax at federal statutory rate $ (33,878) $ (15,274) $ (9,029) State tax, net of federal benefit (5,650) (2,881) (1,977) Effect of foreign operations (7,591) (10) — Permanent items 3,698 234 299 Stock-based compensation 1,952 2,079 190 R&D tax credit (549) (282) (782) Change in valuation allowance 40,328 15,718 11,299 $ (1,690) $ (416) $ — |
Schedule of Significant Components of Net Deferred Tax Assets | Significant components of net deferred tax liabilities are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating losses $ 103,431 $ 73,711 R&D tax credit 10,427 9,538 Accruals and other 13,095 8,671 Operating lease liabilities 4,303 4,695 Depreciation and amortization 402 — 131,658 96,615 Deferred tax liabilities: Depreciation and amortization — (6,257) Operating lease right-of-use assets (3,759) (4,356) (3,759) (10,613) Net deferred tax assets: 127,899 86,002 Valuation allowance (127,899) (87,571) Net deferred tax liability $ — $ (1,569) |
Schedule of Reconciliation of Change in Unrecognized Tax Benefit | A reconciliation of the change in the unrecognized tax benefit during the year is as follows (in thousands): December 31, 2021 2020 2019 Beginning of year $ 2,654 $ 2,485 $ 2,107 Additions for tax positions related to: Current year 245 169 378 Prior years — — — End of year $ 2,899 $ 2,654 $ 2,485 |
Assets and Liabilities Held f_2
Assets and Liabilities Held for Sale (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Disposal Groups, Including Discontinued Operations | The following table summarizes the carrying values of the assets and liabilities classified as held for sale as of December 31, 2021 (in thousands): December 31, 2021 Assets held for sale Cash and cash equivalents $ 558 Accounts receivable, net 1,260 Inventories, net 2,166 Prepaid expenses and other current assets 1,279 Property and equipment, net — Operating lease right-of-use assets — Intangible assets, net — Goodwill — Restricted cash 90 Total assets held for sale 5,353 Liabilities held for sale Accounts payable 1,311 Accrued compensation 2,421 Other current liabilities 1,400 Operating lease liabilities 221 Total liabilities held for sale 5,353 Net assets held for sale $ — |
Organization (Details)
Organization (Details) | Aug. 06, 2021$ / shares |
Merger Agreement, Intersect ENT, Inc. | Medtronic, Inc. | |
Business Acquisition [Line Items] | |
Business acquisition, share price (in USD per share) | $ 28.25 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($)facilityemployee | Dec. 31, 2019USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 17,887 | $ 17,500 | |
Impairment, long-lived asset, held-for-use | $ 600 | ||
Number of operating segments | segment | 2 | ||
Advertising expenses | $ 1,300 | 800 | $ 1,200 |
Employee Severance | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Employee severance costs | $ 200 | ||
Employee Termination | Employee Severance | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Reduction of labor force | employee | 96 | ||
Percentage in reduction of labor force | 25.00% | ||
Furloughed Employees | Employee Severance | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Reduction of labor force | facility | 18 | ||
Percentage in reduction of labor force | 5.00% | ||
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of property and equipment | 2 years | ||
Finite-lived intangible asset, useful life | 3 years | ||
Revenue recognition, payment terms | 30 days | ||
Operating lease, lease term | 24 months | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of property and equipment | 5 years | ||
Finite-lived intangible asset, useful life | 10 years | ||
Revenue recognition, payment terms | 90 days | ||
Operating lease, lease term | 48 months |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Cash, Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Disclosures [Abstract] | |||
Cash and cash equivalents | $ 38,397 | $ 13,521 | |
Restricted cash | 17,887 | 17,500 | |
Total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows | $ 56,284 | $ 31,021 | $ 20,652 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Outstanding Excluded from the Computations of Diluted Weighted Average Shares Outstanding (Detail) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 10,463 | 10,589 | 4,306 |
Common stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 2,930 | 3,172 | 3,209 |
Market-based performance stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 427 | 427 | 427 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 528 | 488 | 511 |
Market-based performance stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 269 | 130 | 89 |
Employee stock purchase plan shares | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 0 | 63 | 70 |
Stock issuable upon conversion of convertible notes | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 6,309 | 6,309 | 0 |
Composition of Certain Financ_3
Composition of Certain Financial Statement Items - Accounts Receivable (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accounts receivable | $ 17,948 | $ 15,079 |
Allowance for doubtful accounts | (622) | (487) |
Accounts receivable, net | $ 17,326 | $ 14,592 |
Composition of Certain Financ_4
Composition of Certain Financial Statement Items - Reserve for Credit Losses on Accounts Receivable (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Beginning | $ 487 | $ 131 | $ 80 |
Additions from acquisition | 0 | 175 | 0 |
Charges, net of recoveries | 332 | 221 | 94 |
Write-offs | (140) | (40) | (43) |
Reclassification to held for sale | (57) | 0 | 0 |
Ending | $ 622 | $ 487 | $ 131 |
Composition of Certain Financ_5
Composition of Certain Financial Statement Items - Components of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 3,122 | $ 2,865 |
Work-in-process | 4,113 | 3,411 |
Finished goods | 11,364 | 5,778 |
Inventory | $ 18,599 | $ 12,054 |
Composition of Certain Financ_6
Composition of Certain Financial Statement Items - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||||
Idle expenses in inventory | $ 6.1 | |||
Increased reserve for excess and obsolete inventory | 0.8 | |||
Inventory valuation reserves | $ 1.1 | $ 1.5 | $ 1.1 | $ 1.5 |
Share-based payment arrangement, amount capitalized | 0.1 | $ 0.3 | ||
Implementation costs, amount capitalized | 3.6 | |||
Hosting Arrangement, Service Contract, Implementation Cost, Expense, Amortization | 0.2 | |||
Prepaid expenses and other current assets | ||||
Property, Plant and Equipment [Line Items] | ||||
Hosting Arrangement, Service Contract, Implementation Cost, Capitalized, after Accumulated Amortization | 1.1 | 1.1 | ||
Other non-current assets | ||||
Property, Plant and Equipment [Line Items] | ||||
Hosting Arrangement, Service Contract, Implementation Cost, Capitalized, after Accumulated Amortization | $ 2.2 | $ 2.2 |
Composition of Certain Financ_7
Composition of Certain Financial Statement Items - Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Plant and equipment, gross | $ 16,128 | $ 16,094 |
Less: accumulated depreciation and amortization | (11,133) | (10,470) |
Plant and equipment, net | 4,995 | 5,624 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Plant and equipment, gross | 2,370 | 2,159 |
Furniture and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Plant and equipment, gross | 1,598 | 1,611 |
Laboratory and manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Plant and equipment, gross | 8,057 | 8,939 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Plant and equipment, gross | $ 4,103 | $ 3,385 |
Composition of Certain Financ_8
Composition of Certain Financial Statement Items - Disaggregation of Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Disaggregation of Revenue [Line Items] | |||
Revenues | $ 106,748 | $ 80,554 | $ 109,142 |
PROPEL family of products | |||
Disaggregation of Revenue [Line Items] | |||
Revenues | 91,117 | 74,335 | 104,657 |
SINUVA | |||
Disaggregation of Revenue [Line Items] | |||
Revenues | 9,074 | 5,315 | 4,485 |
VenSure, CUBE, and accessories | |||
Disaggregation of Revenue [Line Items] | |||
Revenues | $ 6,557 | $ 904 | $ 0 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Summary of Cash, Cash Equivalents and Short-Term Investments Available-for-Sale, by Type of Instrument (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Net Investment Income [Line Items] | ||
Cash and cash equivalents | $ 38,397 | $ 13,521 |
Short-term investments | 22,618 | 74,506 |
Fair Value, Recurring | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 38,397 | 13,521 |
Short-term investments | 22,618 | 74,506 |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 61,025 | 88,026 |
Cash, cash equivalents and available-for-sale debt securities | 61,015 | 88,027 |
Gross Unrealized, Gains | 0 | 7 |
Gross Unrealized, Losses | (10) | (6) |
Level 1: | Fair Value, Recurring | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 38,397 | 12,517 |
Level 2: | Fair Value, Recurring | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 0 | 1,004 |
Short-term investments | 22,618 | 74,506 |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 22,628 | 75,509 |
Cash, cash equivalents and available-for-sale debt securities | 22,618 | 75,510 |
Gross Unrealized, Gains | 0 | 7 |
Gross Unrealized, Losses | (10) | (6) |
Level 2: | Fair Value, Recurring | U.S. treasury bills | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 0 | 1,004 |
Short-term investments | 7,075 | 48,695 |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 7,080 | 49,698 |
Cash, cash equivalents and available-for-sale debt securities | 7,075 | 49,699 |
Gross Unrealized, Gains | 0 | 4 |
Gross Unrealized, Losses | (5) | (3) |
Level 2: | Fair Value, Recurring | Corporate debt securities | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Short-term investments | 9,552 | 6,305 |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 9,557 | 6,307 |
Cash, cash equivalents and available-for-sale debt securities | 9,552 | 6,305 |
Gross Unrealized, Gains | 0 | 0 |
Gross Unrealized, Losses | (5) | (2) |
Level 2: | Fair Value, Recurring | Commercial paper | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 0 | 0 |
Short-term investments | 5,991 | |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 5,991 | |
Cash, cash equivalents and available-for-sale debt securities | 5,991 | |
Gross Unrealized, Gains | 0 | |
Gross Unrealized, Losses | 0 | |
Level 2: | Fair Value, Recurring | U.S. government agency bonds | ||
Net Investment Income [Line Items] | ||
Short-term investments | 19,506 | |
Cash, cash equivalents and available-for-sale debt securities, amortized cost | 19,504 | |
Cash, cash equivalents and available-for-sale debt securities | 19,506 | |
Gross Unrealized, Gains | 3 | |
Gross Unrealized, Losses | (1) | |
Cash | Level 1: | Fair Value, Recurring | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | 9,101 | 9,755 |
Money market funds | Level 1: | Fair Value, Recurring | ||
Net Investment Income [Line Items] | ||
Cash and cash equivalents | $ 29,296 | $ 2,762 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value Disclosures [Abstract] | ||
Investments with a contractual maturity of greater than one year | $ 0 | $ 0 |
Fair value of embedded derivatives | $ 16,200,000 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Summary of changes in the fair value of derivative liabilities (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Fair value adjustment | $ 13,138 | $ 1,248 | $ 0 |
Ending balance | 16,200 | ||
Fair Value, Inputs, Level 3 | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Beginning balance | 3,048 | 0 | |
Additions | 0 | 1,800 | |
Fair value adjustment | 13,138 | 1,248 | |
Ending balance | $ 16,186 | $ 3,048 | $ 0 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Cash Equivalents and Short-Term Investments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Amortized Cost | |
Maturity in less than one year | $ 19,617 |
Maturity in one to five years | 3,011 |
Total | 22,628 |
Fair Value | |
Maturity in less than one year | 19,609 |
Maturity in one to five years | 3,009 |
Total | $ 22,618 |
Derivative Financial Instrume_2
Derivative Financial Instruments - Gross Notional Amounts on Foreign currency Exchange Contracts Not Designated as Hedging Instruments (Details) - Forward contracts - Not Designated as Hedging Instrument € in Thousands, $ in Thousands | Dec. 31, 2021USD ($) | Dec. 31, 2021EUR (€) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) |
Derivative [Line Items] | ||||
Notional amount | $ 36,900 | € 30,000 | $ 55,000 | € 45,000 |
Prepaid expenses and other current assets | ||||
Derivative [Line Items] | ||||
Fair value of the derivative liabilities | 0 | 275 | ||
Other non-current assets | ||||
Derivative [Line Items] | ||||
Fair value of the derivative liabilities | 0 | 558 | ||
Other current liabilities | ||||
Derivative [Line Items] | ||||
Fair value of the derivative liabilities | 1,141 | 0 | ||
Other non-current liabilities | ||||
Derivative [Line Items] | ||||
Fair value of the derivative liabilities | $ 1,070 | $ 0 |
Derivative Financial Instrume_3
Derivative Financial Instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Derivative [Line Items] | |||
Foreign exchange gains (losses) on remeasurement of deferred acquisition related consideration | $ 2,498 | $ (2,233) | $ 0 |
Forward contracts | |||
Derivative [Line Items] | |||
Recognized gains (losses) on foreign currency exchange contracts | (3,045) | 833 | |
Foreign exchange gains (losses) on remeasurement of deferred acquisition related consideration | $ 3,785 | $ (2,388) |
Business Combinations - Additio
Business Combinations - Additional Information (Details) $ in Thousands, € in Millions | Oct. 02, 2020USD ($) | Oct. 02, 2020EUR (€) | Oct. 31, 2021EUR (€) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Oct. 02, 2020EUR (€) |
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Deferred purchase consideration for a business combination | $ 0 | $ 51,341 | $ 0 | ||||
Goodwill | $ 0 | 46,639 | |||||
Finite-lived intangible assets, remaining amortization period | 9 years 1 month 6 days | ||||||
Revenue | $ 106,748 | 80,554 | 109,142 | ||||
Net loss | 159,635 | 72,319 | 42,994 | ||||
Interest expense | 6,437 | 2,752 | 0 | ||||
Other income (expense), net | (13,847) | (2,331) | 2,400 | ||||
Selling, general and administrative | 122,068 | 98,550 | 108,480 | ||||
Cost of sales | 30,012 | 30,306 | 21,773 | ||||
Accumulated amortization | 2,800 | 707 | |||||
Trademarks | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Accumulated amortization | 12 | ||||||
Minimum | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Goodwill, purchase accounting adjustments | 400 | ||||||
Maximum | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Goodwill, purchase accounting adjustments | 47,000 | ||||||
Fiagon AG Medical | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Payments to acquire business | $ 17,600 | € 15 | |||||
Purchase price adjustment | € | € 2.5 | ||||||
Total purchase consideration | 69,300 | ||||||
Deferred purchase consideration for a business combination | 51,700 | 32,400 | 54,200 | ||||
Escrow deposit | 17,500 | € 15 | |||||
Assets | 4,600 | ||||||
Inventory assumed | 2,200 | ||||||
Liabilities assumed | 4,200 | ||||||
Business combination, recognized identifiable assets acquired and liabilities assumed, deferred tax liabilities | 2,200 | ||||||
Intangible assets | 21,900 | ||||||
Goodwill | $ 46,600 | ||||||
Revenue | 6,600 | 900 | |||||
Net loss | 10,500 | 2,300 | |||||
Interest expense | 1,900 | 500 | |||||
Business combination, acquisition related costs | 6,100 | ||||||
Fiagon AG Medical | Trademarks | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Impairment of intangible assets, finite-lived | $ 200 | ||||||
Fiagon AG Medical | Pro Forma | |||||||
Business Acquisition, Contingent Consideration [Line Items] | |||||||
Interest expense | 800 | 1,900 | |||||
Other income (expense), net | (1,500) | 1,200 | |||||
Selling, general and administrative | $ 600 | 6,500 | |||||
Cost of sales | 600 | ||||||
Business combination, acquisition and integration related costs | $ 4,000 |
Business Combinations - Pro For
Business Combinations - Pro Forma Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Actual [Abstract] | ||
Revenue | $ 82,797 | |
Net loss | $ (77,504) | |
Net loss per share, basic and diluted (in dollars per share) | $ (2.38) | |
Pro Forma [Abstract] | ||
Revenue | $ 120,998 | |
Net loss | $ (50,707) | |
Net loss per share, basic and diluted (in dollars per share) | $ (1.62) |
Business Combinations - Intangi
Business Combinations - Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 21,900 | |
Accumulated Amortization | $ (2,800) | (707) |
Net Carrying Amount | 21,193 | |
Developed technology | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 19,100 | |
Accumulated Amortization | (478) | |
Net Carrying Amount | 18,622 | |
Distribution network | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 1,100 | |
Accumulated Amortization | (92) | |
Net Carrying Amount | 1,008 | |
Customer relationships | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 1,500 | |
Accumulated Amortization | (125) | |
Net Carrying Amount | 1,375 | |
Trademarks | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 200 | |
Accumulated Amortization | (12) | |
Net Carrying Amount | $ 188 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)facility | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Leases [Abstract] | |||
Number of leased facilities | facility | 4 | ||
Operating lease, expense | $ | $ 5.2 | $ 4.3 | $ 2.4 |
Number of leased facilities held-for-sale | facility | 2 | ||
Operating lease, payments | $ | $ 4.4 | $ 2.2 | $ 1.8 |
Leases - Operating Lease Liabil
Leases - Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Current portion presented in other current liabilities | $ 1,975 | $ 762 |
Non-current portion presented in operating lease liabilities | 14,709 | 17,736 |
Total | $ 16,684 | $ 18,498 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Leases - Operating Lease Paymen
Leases - Operating Lease Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 3,645 | |
2023 | 4,088 | |
2024 | 4,126 | |
2025 | 4,058 | |
2026 | 4,200 | |
Thereafter | 4,347 | |
Total minimum payments | 24,464 | |
Less: present value adjustment | (5,931) | |
Less: tenant improvement allowance | (1,849) | |
Total | $ 16,684 | $ 18,498 |
Leases - Term and Discount Rate
Leases - Term and Discount Rates (Details) | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Weighted-average remaining lease term (years) | 5 years 10 months 24 days | 6 years 9 months 18 days |
Weighted-average discount rate | 9.50% | 9.50% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2021 | Apr. 30, 2021 | Feb. 28, 2021 | Feb. 29, 2020 | Nov. 30, 2019 | Jul. 31, 2019 | Jun. 30, 2018 | Jan. 31, 2017 | Apr. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 31, 2014 |
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares authorized (in shares) | 9,994,000 | 9,994,000 | |||||||||||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 | |||||||||||
Revenue | $ 106,748 | $ 80,554 | $ 109,142 | ||||||||||
Change in fair value of embedded derivatives | 13,138 | 1,248 | 0 | ||||||||||
Fair Value, Inputs, Level 3 | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Change in fair value of embedded derivatives | 13,138 | 1,248 | |||||||||||
Restricted stock units | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Aggregate intrinsic value of RSUs outstanding | $ 14,400 | ||||||||||||
Weighted-average remaining contractual term of RSUs outstanding (in years) | 1 year 10 months 24 days | ||||||||||||
Common stock options | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Outstanding options subject to vesting conditions to purchase shares (in shares) | 427,147 | ||||||||||||
Outstanding options subject to vesting conditions to purchase shares, exercise price (in usd per share) | $ 20.44 | ||||||||||||
Aggregate intrinsic value of options outstanding | $ 19,600 | ||||||||||||
Aggregate intrinsic value of options outstanding and exercisable | $ 8,600 | ||||||||||||
Weighted-average remaining contractual term of options outstanding (in years) | 7 years 7 months 6 days | ||||||||||||
Weighted-average remaining contractual term of options exercisable (in years) | 6 years 7 months 6 days | ||||||||||||
Aggregate intrinsic value of options exercised | $ 4,000 | $ 2,000 | $ 11,400 | ||||||||||
Granted (in shares) | 943,000 | ||||||||||||
Expected volatility | 66.00% | 58.00% | 48.00% | ||||||||||
Risk-free interest rate | 0.70% | 0.90% | 2.20% | ||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | ||||||||||
Granted (in usd per share) | $ 22.52 | ||||||||||||
Expected term (years) | 6 years | 6 years | 6 years | ||||||||||
Performance stock units | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 3 years | 2 years | 3 years | ||||||||||
Aggregate intrinsic value of RSUs outstanding | $ 7,300 | ||||||||||||
Weighted-average remaining contractual term of RSUs outstanding (in years) | 1 year 6 months | ||||||||||||
Granted (in shares) | 20,687 | 166,708 | 102,685 | 89,024 | |||||||||
Grant date fair value of options | $ 1,300 | ||||||||||||
Fair value of options amortization period | 3 years | ||||||||||||
Performance stock units | Monte Carlo Simulation Model | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Grant date fair value of options | $ 1,800 | $ 4,700 | |||||||||||
Expected volatility | 46.70% | 47.30% | 61.00% | ||||||||||
Risk-free interest rate | 1.30% | 1.60% | 0.10% | ||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | ||||||||||
Share-based payment arrangement, expensed and capitalized, amount | $ 1,300 | ||||||||||||
Performance stock units | Share-based Payment Arrangement, Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting amount, percentage | 50.00% | ||||||||||||
Share-based compensation arrangement by share-based payment award, TSR multiplier | 0.8 | ||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | $ 37 | $ 28 | |||||||||||
Performance stock units | Share-based Payment Arrangement, Tranche One | Minimum | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Revenue | $ 126,000 | ||||||||||||
Performance stock units | Share-based Payment Arrangement, Tranche Two | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, TSR multiplier | 1 | ||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | 46 | 34 | |||||||||||
Performance stock units | Share-based Payment Arrangement, Tranche Two | Minimum | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Revenue | $ 140,000 | ||||||||||||
Performance stock units | Share-based Payment Arrangement, Tranche Three | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting amount, percentage | 150.00% | ||||||||||||
Share-based compensation arrangement by share-based payment award, TSR multiplier | 1.2 | ||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | $ 55 | $ 41 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Minimum Revenue Target' | $ 161,000 | ||||||||||||
Market Based Vesting Option | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 3 years | ||||||||||||
Granted (in shares) | 427,147 | ||||||||||||
Granted (in usd per share) | $ 20.44 | ||||||||||||
Fair value of options amortization period | 3 years | ||||||||||||
Market Based Vesting Option | Monte Carlo Simulation Model | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Expected volatility | 47.30% | ||||||||||||
Risk-free interest rate | 1.90% | ||||||||||||
Dividend yield | 0.00% | ||||||||||||
Share based compensation arrangement by share based payment award options granted in period fair value | $ 2,900 | ||||||||||||
Expected term (years) | 6 years 6 months | ||||||||||||
Market Based Vesting Option | Share-based Payment Arrangement, Tranche One | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | $ 32 | ||||||||||||
Market Based Vesting Option | Share-based Payment Arrangement, Tranche Two | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | 40 | ||||||||||||
Market Based Vesting Option | Share-based Payment Arrangement, Tranche Three | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Options vesting average closing share price threshold 30-day trailing (in USD per share) | $ 48 | ||||||||||||
Employee stock purchase plan shares | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, capital shares reserved for future issuance, increase during period (in shares) | 1,200,000 | ||||||||||||
Expected volatility | 52.00% | 82.00% | 49.00% | ||||||||||
Risk-free interest rate | 0.00% | 0.10% | 2.00% | ||||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | ||||||||||
Expected term (years) | 6 months | 6 months | 6 months | ||||||||||
Shares authorized for future issuance (in shares) | 1,696,092 | 496,092 | |||||||||||
Shares issued (in shares) | 100,000 | 100,000 | 200,000 | ||||||||||
2014 Equity Incentive Plan | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Shares reserved for issuance (in shares) | 10,922,838 | 3,625,223 | 4,750,000 | ||||||||||
Percentage of shares outstanding | 3.00% | ||||||||||||
Maximum number of shares to be issued (in shares) | 10,000,000 | ||||||||||||
Vesting amount, percentage | 25.00% | ||||||||||||
Award service period | 36 months | ||||||||||||
Expiration period | 10 years | ||||||||||||
Common stock, capital shares reserved for future issuance, increase during period (in shares) | 988,070 | ||||||||||||
2014 Equity Incentive Plan | Restricted stock units | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Vesting period | 3 years | ||||||||||||
Series DF-1 Convertible Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares authorized (in shares) | 6,310 | 6,000 | 10,000,000 | ||||||||||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 | |||||||||||
Number of common shares issuable per converted share (in shares) | 1,000 | ||||||||||||
Conversion of stock, shares issuable (in shares) | 6,309,459 | ||||||||||||
Incentive Stock Option | 2014 Equity Incentive Plan | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Price of options granted, percentage | 100.00% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) - Common stock options shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Options | |
Outstanding, beginning of period (in shares) | shares | 3,599 |
Granted (in shares) | shares | 943 |
Exercised (in shares) | shares | (388) |
Forfeited (in shares) | shares | (797) |
Outstanding, end of period (in shares) | shares | 3,357 |
Exercisable (in shares) | shares | 1,574 |
Weighted Average Exercise Price | |
Outstanding, beginning of period (in usd per share) | $ / shares | $ 22.01 |
Granted (in usd per share) | $ / shares | 22.52 |
Exercised (in usd per share) | $ / shares | 14.63 |
Forfeited (in usd per share) | $ / shares | 25.33 |
Outstanding, end of period (in usd per share) | $ / shares | 22.22 |
Exercisable (in usd per share) | $ / shares | $ 23.22 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Units Activity (Detail) - Restricted stock units shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
RSUs | |
Outstanding, beginning of period (in shares) | shares | 488 |
Awarded (in shares) | shares | 385 |
Vested (in shares) | shares | (210) |
Forfeited (in shares) | shares | (135) |
Outstanding, end of period (in shares) | shares | 528 |
Weighted Average Fair Value | |
Outstanding, beginning of period (in usd per share) | $ / shares | $ 23.88 |
Awarded (in usd per share) | $ / shares | 23.40 |
Vested (in usd per share) | $ / shares | 24.10 |
Forfeited (in usd per share) | $ / shares | 23.33 |
Outstanding, end of period (in usd per share) | $ / shares | $ 23.58 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Performance Stock Units Activity (Detail) - Performance Stock Units shares in Thousands | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
PSUs | |
Outstanding, beginning of period (in shares) | shares | 130 |
Awarded (in shares) | shares | 188 |
Forfeited (in shares) | shares | (49) |
Outstanding, end of period (in shares) | shares | 269 |
Weighted Average Fair Value | |
Outstanding, beginning of period (in usd per share) | $ / shares | $ 15.94 |
Awarded (in usd per share) | $ / shares | 24.99 |
Forfeited (in usd per share) | $ / shares | 21.93 |
Outstanding, end of period (in usd per share) | $ / shares | $ 21.16 |
Stock-based Compensation Expe_3
Stock-based Compensation Expense - Summary of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 16,456 | $ 14,958 | $ 20,149 |
Cost of sales | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 1,543 | 1,805 | 1,273 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 12,901 | 11,493 | 15,709 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 2,012 | $ 1,660 | $ 3,167 |
Stock-based Compensation Expe_4
Stock-based Compensation Expense - Additional Information (Detail) $ in Millions | Dec. 31, 2021USD ($) |
Share-based Payment Arrangement [Abstract] | |
Unearned stock-based compensation | $ 27.5 |
Weighted average period for unearned stock-based compensation to be recognized | 2 years 3 months 18 days |
Stock-based Compensation Expe_5
Stock-based Compensation Expense - Summary of Weighted Average Assumptions Used to Estimate Options Using Black-Scholes Model (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee stock purchase plan shares | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (years) | 6 months | 6 months | 6 months |
Expected volatility | 52.00% | 82.00% | 49.00% |
Risk-free interest rate | 0.00% | 0.10% | 2.00% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Fair value (in usd per share) | $ 5.29 | $ 5.67 | $ 6.71 |
Common stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (years) | 6 years | 6 years | 6 years |
Expected volatility | 66.00% | 58.00% | 48.00% |
Risk-free interest rate | 0.70% | 0.90% | 2.20% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Fair value (in usd per share) | $ 13.29 | $ 10.87 | $ 11.74 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) | Sep. 25, 2021USD ($) | Jul. 22, 2021USD ($) | May 11, 2020USD ($)day$ / shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | ||||||
Amortization of the convertible debt discount and issuance costs | $ 938,000 | $ 561,000 | $ 0 | |||
Accrued interest | 700,000 | 700,000 | ||||
Convertible notes fair value | 133,900,000 | |||||
Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Accrued Interest Payable | 200,000 | |||||
Embedded Derivative Financial Instruments | ||||||
Debt Instrument [Line Items] | ||||||
Embedded derivative liability | $ 1,800,000 | |||||
Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Face amount of debt | $ 65,000,000 | |||||
Interest rate | 4.00% | |||||
Conversion ratio | 0.0643501 | |||||
Debt instrument, convertible, conversion price (in usd per share) | $ / shares | $ 15.54 | |||||
Long-term debt | $ 61,800,000 | 77,701,000 | 63,650,000 | |||
Percentage of shares held after conversion of convertible notes | 4.985% | |||||
Debt instrument, covenant, enterprise value threshold | 50.00% | |||||
Debt instrument, unamortized discount | $ 1,800,000 | |||||
Debt issuance costs, net | 3,200,000 | |||||
Amortization of the convertible debt discount and issuance costs | 900,000 | 600,000 | ||||
Outstanding principal amount of convertible notes | $ 65,000,000 | 65,000,000 | $ 65,000,000 | |||
Convertible Debt | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption, notification period | day | 10 | |||||
Convertible Debt | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption, notification period | day | 60 | |||||
Convertible Debt | Period one | ||||||
Debt Instrument [Line Items] | ||||||
Redemption of convertible notes | $ 32,500,000 | |||||
Debt instrument, convertible, threshold trading days | day | 20 | |||||
Debt instrument, convertible, threshold consecutive trading days | day | 30 | |||||
Debt instrument, redemption price, percentage | 150.00% | |||||
Convertible Debt | Period two | ||||||
Debt Instrument [Line Items] | ||||||
Redemption of convertible notes | $ 65,000,000 | |||||
Debt instrument, convertible, threshold trading days | day | 20 | |||||
Debt instrument, convertible, threshold consecutive trading days | day | 30 | |||||
Debt instrument, redemption price, percentage | 200.00% | |||||
Senior Loans | Deerfield Term Loans | ||||||
Debt Instrument [Line Items] | ||||||
Face amount of debt | $ 60,000,000 | |||||
Interest rate | 7.50% | |||||
Long-term debt | 19,644,000 | |||||
Outstanding principal amount of convertible notes | 20,000,000 | |||||
Debt instrument, loan prepayment period | 30 months | |||||
Debt instrument, prepayment exit fee, percentage of principal | 1.75% | |||||
Debt Instrument, Interest Rate, Undrawn Tranche | 0.25% | |||||
Senior Loans | Deerfield Term Loans | Other current liabilities | ||||||
Debt Instrument [Line Items] | ||||||
Accrued interest | 300,000 | |||||
Senior Loans | Period one | Deerfield Term Loans | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | $ 20,000,000 | |||||
Debt instrument, prepayment premium, percentage of principal | 0.75% | |||||
Senior Loans | Period two | Deerfield Term Loans | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | $ 20,000,000 | |||||
Debt instrument, prepayment premium, percentage of principal | 0.50% | |||||
Senior Loans | Period three | Deerfield Term Loans | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | $ 20,000,000 | |||||
Debt instrument, prepayment premium, percentage of principal | 9.75% | |||||
Subordinated Debt | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Face amount of debt | $ 75,000,000 | |||||
Interest rate | 5.00% | |||||
Long-term debt | $ 30,000,000 | |||||
Debt instrument, term | 180 days | |||||
Subordinated Debt | Period one | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | $ 15,000,000 | |||||
Subordinated Debt | Period two | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | 15,000,000 | |||||
Subordinated Debt | Period three | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | 15,000,000 | |||||
Subordinated Debt | Period five | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | 15,000,000 | |||||
Subordinated Debt | Period four | Medtronic Financing | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, redemption amount | $ 15,000,000 |
Long-Term Debt - Summary of net
Long-Term Debt - Summary of net carrying amount of the convertible notes (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | May 11, 2020 |
Debt Instrument [Line Items] | |||
Fair value of embedded derivatives | $ 16,200 | ||
Convertible Debt | |||
Debt Instrument [Line Items] | |||
Outstanding principal amount of convertible notes | 65,000 | $ 65,000 | $ 65,000 |
Unamortized debt discount and transaction costs | (3,485) | (4,398) | |
Fair value of embedded derivatives | 16,186 | 3,048 | |
Convertible notes, net | 77,701 | $ 63,650 | $ 61,800 |
Senior Loans | Deerfield Term Loans | |||
Debt Instrument [Line Items] | |||
Outstanding principal amount of convertible notes | 20,000 | ||
Unamortized debt discount and transaction costs | (387) | ||
Accrued exit fee | 31 | ||
Convertible notes, net | $ 19,644 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | Sep. 23, 2021plantiff | Sep. 15, 2021defendant | Sep. 01, 2021claim | Jul. 31, 2022USD ($) | Dec. 31, 2021USD ($) |
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Accrued royalties | $ 0.2 | ||||
Non-cancellable commitments to suppliers for purchases | 12 | ||||
Anticipated Settlement Costs, Funded | 0.3 | ||||
Wang Complaint | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Loss contingency, new claims filed, number | claim | 7 | ||||
Lawson Complaint | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Loss contingency, number of plaintiffs | plantiff | 2 | ||||
Deferred Bonus | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Deferred compensation arrangement with individual, recorded liability | 7.9 | ||||
Employees | Deferred Bonus | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Deferred compensation arrangement with individual, compensation expense | $ 7.9 | ||||
Employees | Forecast | Deferred Bonus | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Deferred compensation arrangement with individual, compensation expense | $ 15 | ||||
Director | Lawson Complaint | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Loss contingency, number of defendants | defendant | 5 | ||||
Director, Former | Lawson Complaint | |||||
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items] | |||||
Loss contingency, number of defendants | defendant | 1 |
Employee Retirement Plan - Addi
Employee Retirement Plan - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2007 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | ||||
Maximum annual contribution per employee, percent | 100.00% | |||
Contributions, annual vesting percentage | 25.00% | |||
Contributions, vesting period | 4 years | |||
Profit sharing or matching contribution by employer | $ 1.1 | $ 1 | $ 1.1 |
Income Taxes - Domestic and For
Income Taxes - Domestic and Foreign Components of Loss Before Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (93,593) | $ (70,801) | $ (42,994) |
Foreign | (67,732) | (1,934) | 0 |
Loss before income taxes | $ (161,325) | $ (72,735) | $ (42,994) |
Income Taxes - Provision (Detai
Income Taxes - Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 110 | 20 | 0 |
Total current | 110 | 20 | 0 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | (1,800) | (436) | 0 |
Total deferred | (1,800) | (436) | 0 |
Income tax (benefit) | $ (1,690) | $ (416) | $ 0 |
Income Taxes - Schedule of Fede
Income Taxes - Schedule of Federal Statutory Rate to Loss Before Income Taxes Reconciles to Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Tax at federal statutory rate | $ (33,878) | $ (15,274) | $ (9,029) |
State tax, net of federal benefit | (5,650) | (2,881) | (1,977) |
Effect of foreign operations | (7,591) | (10) | 0 |
Permanent items | 3,698 | 234 | 299 |
Stock-based compensation | 1,952 | 2,079 | 190 |
R&D tax credit | (549) | (282) | (782) |
Change in valuation allowance | 40,328 | 15,718 | 11,299 |
Income tax (benefit) | $ (1,690) | $ (416) | $ 0 |
Income Taxes - Schedule of Sign
Income Taxes - Schedule of Significant Components of Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating losses | $ 103,431 | $ 73,711 |
R&D tax credit | 10,427 | 9,538 |
Accruals and other | 13,095 | 8,671 |
Operating lease liabilities | 4,303 | 4,695 |
Depreciation and amortization | 402 | 0 |
Gross deferred tax assets | 131,658 | 96,615 |
Deferred tax liabilities: | ||
Depreciation and amortization | 0 | (6,257) |
Operating lease right-of-use assets | (3,759) | (4,356) |
Deferred tax liabilities, gross | (3,759) | (10,613) |
Net deferred tax assets: | 127,899 | 86,002 |
Valuation allowance | (127,899) | (87,571) |
Net deferred tax liability | $ 0 | $ (1,569) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 02, 2020 | Dec. 31, 2018 | |
Income Tax Contingency [Line Items] | |||||
Fair value of embedded derivatives | $ 16,200 | ||||
Increase (decrease) in valuation allowance | 40,300 | $ 15,800 | |||
Net operating loss carryforwards, federal | 318,800 | ||||
Deferred tax assets, operating loss carryforwards, subject to expiration | 148,400 | ||||
Deferred tax assets, operating loss carryforwards, not subject to expiration | 170,400 | ||||
Research and development tax credits | 10,427 | 9,538 | |||
Net operating loss carryforwards, state | 71,600 | ||||
Deferred tax assets, operating loss carryforwards, foreign | 18,400 | ||||
Unrecognized tax benefits | 2,899 | 2,654 | $ 2,485 | $ 2,107 | |
Permanent items | 3,698 | $ 234 | $ 299 | ||
Embedded Derivative Financial Instruments | |||||
Income Tax Contingency [Line Items] | |||||
Permanent items | 2,800 | ||||
Fiagon AG Medical | |||||
Income Tax Contingency [Line Items] | |||||
Business combination, recognized identifiable assets acquired and liabilities assumed, deferred tax liabilities | $ 2,200 | ||||
Federal | |||||
Income Tax Contingency [Line Items] | |||||
Research and development tax credits | 7,500 | ||||
State | |||||
Income Tax Contingency [Line Items] | |||||
Research and development tax credits | $ 7,000 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Change in Unrecognized Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Beginning of year | $ 2,654 | $ 2,485 | $ 2,107 |
Additions for tax positions related to: | |||
Current year | 245 | 169 | 378 |
Prior years | 0 | 0 | 0 |
End of year | $ 2,899 | $ 2,654 | $ 2,485 |
Assets and Liabilities Held f_3
Assets and Liabilities Held for Sale - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Impairment on assets held for sale | $ 67,765 | $ 0 | $ 0 |
Fiagon AG Medical | Disposal Group, Held-for-sale, Not Discontinued Operations | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Disposal group, including discontinued operations, estimated selling costs | 1,000 | ||
Fiagon AG Medical | Disposal Group, Held-for-sale, Not Discontinued Operations | Inventories | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Disposal group, including discontinued operations, estimated selling costs | 300 | ||
Fiagon AG Medical | Disposal Group, Held-for-sale, Not Discontinued Operations | Accounts Payable | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Disposal group, including discontinued operations, estimated selling costs | $ 700 |
Assets and Liabilities Held f_4
Assets and Liabilities Held for Sale (Details) - Disposal Group, Held-for-sale, Not Discontinued Operations - Fiagon AG Medical $ in Thousands | Dec. 31, 2021USD ($) |
Assets held for sale | |
Cash and cash equivalents | $ 558 |
Accounts receivable, net | 1,260 |
Inventories, net | 2,166 |
Prepaid expenses and other current assets | 1,279 |
Property and equipment, net | 0 |
Operating lease right-of-use assets | 0 |
Intangible assets, net | 0 |
Goodwill | 0 |
Restricted cash | 90 |
Total assets held for sale | 5,353 |
Liabilities held for sale | |
Accounts payable | 1,311 |
Accrued compensation | 2,421 |
Other current liabilities | 1,400 |
Operating lease liabilities | 221 |
Total liabilities held for sale | 5,353 |
Net assets held for sale | $ 0 |
Uncategorized Items - xent-2021
Label | Element | Value |
Cash, Cash Equivalents, Restricted Cash and Restricted Cash Equivalents, Including Disposal Group and Discontinued Operations | us-gaap_CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations | $ 9,464,000 |