Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38593 | |
Entity Registrant Name | Establishment Labs Holdings Inc. | |
Entity Incorporation, State or Country Code | D8 | |
Entity Address, Address Line One | Building B15 and 25 | |
Entity Address, Address Line Two | Coyol Free Zone | |
Entity Address, City or Town | Alajuela | |
Entity Address, Country | CR | |
Country Region | 506 | |
City Area Code | 24 | |
Local Phone Number | 34 2400 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Shares, No Par Value | |
Trading Symbol | ESTA | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 24,197,836 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001688757 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 44,656 | $ 53,415 |
Accounts receivable, net of allowance for doubtful accounts of $1,317 and $1,221 | 29,689 | 24,437 |
Inventory, net | 28,538 | 28,407 |
Prepaid expenses and other current assets | 7,133 | 7,012 |
Total current assets | 110,016 | 113,271 |
Long-term assets: | ||
Property and equipment, net of accumulated depreciation | 23,301 | 18,658 |
Goodwill | 465 | 465 |
Intangible assets, net of accumulated amortization | 4,470 | 4,371 |
Right-of-use operating lease assets, net | 2,113 | 2,206 |
Other non-current assets | 1,191 | 558 |
Total assets | 141,556 | 139,529 |
Current liabilities: | ||
Accounts payable | 16,651 | 14,475 |
Accrued liabilities | 18,057 | 16,236 |
Other liabilities, short-term | 1,802 | 1,178 |
Total current liabilities | 36,510 | 31,889 |
Long-term liabilities: | ||
Note payable, Madryn, net of debt discount and issuance costs | 52,486 | 51,906 |
Madryn put option | 1,099 | 703 |
Operating lease liabilities, non-current | 1,805 | 1,900 |
Other liabilities, long-term | 1,821 | 2,392 |
Total liabilities | 93,721 | 88,790 |
Commitments and contingencies (Note 13) | ||
Shareholders’ equity: | ||
Common shares - zero par value, unlimited amount authorized; 24,602,156 and 24,488,335 shares issued at March 31, 2022 and December 31, 2021, respectively; 24,194,086 and 24,080,265 shares outstanding at March 31, 2022 and December 31, 2021, respectively | 221,439 | 219,737 |
Additional paid-in-capital | 40,018 | 36,584 |
Treasury shares, at cost, 408,070 shares held at March 31, 2022 and December 31, 2021 | (2,854) | (2,854) |
Accumulated deficit | (212,318) | (206,385) |
Accumulated other comprehensive income | 1,550 | 3,657 |
Total shareholders’ equity | 47,835 | 50,739 |
Total liabilities and shareholders’ equity | $ 141,556 | $ 139,529 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 1,317 | $ 1,221 |
Common stock, shares issued (in shares) | 24,602,156 | 24,488,335 |
Common stock, shares outstanding (in shares) | 24,194,086 | 24,080,265 |
Treasury stock, shares held (in shares) | 408,070 | 408,070 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Revenue | $ 38,452 | $ 30,336 |
Cost of revenue | 13,516 | 10,246 |
Gross profit | 24,936 | 20,090 |
Operating expenses: | ||
Sales, general and administrative | 26,913 | 18,138 |
Research and development | 3,598 | 4,048 |
Total operating expenses | 30,511 | 22,186 |
Loss from operations | (5,575) | (2,096) |
Interest income | 20 | 4 |
Interest expense | (2,292) | (2,195) |
Change in fair value of derivative instruments | (396) | 230 |
Other income (expense), net | 2,709 | (2,726) |
Loss before income taxes | (5,534) | (6,783) |
Provision for income taxes | (399) | (165) |
Net loss | $ (5,933) | $ (6,948) |
Basic net loss per share (in dollars per share) | $ (0.24) | $ (0.29) |
Diluted net loss per share (in dollars per share) | $ (0.24) | $ (0.29) |
Weighted average outstanding shares used for basic net loss per share (in shares) | 24,310,856 | 23,827,137 |
Weighted average outstanding shares used for diluted net loss per share (in shares) | 24,310,856 | 23,827,137 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (5,933) | $ (6,948) |
Other comprehensive income (loss): | ||
Foreign currency translation gain (loss) | (2,107) | 941 |
Other comprehensive gain (loss) | (2,107) | 941 |
Comprehensive loss | $ (8,040) | $ (6,007) |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Shareholders’ Equity - USD ($) $ in Thousands | Total | Common Shares | Treasury Shares | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income |
Beginning balance (in shares) at Dec. 31, 2020 | 23,925,789 | 408,070 | ||||
Beginning balance at Dec. 31, 2020 | $ 74,961 | $ 213,471 | $ (2,854) | $ 26,717 | $ (165,246) | $ 2,873 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock option exercises (in shares) | 163,034 | |||||
Stock option exercises | 1,882 | $ 1,882 | ||||
Share-based compensation (in shares) | 5,939 | |||||
Share-based compensation | 1,756 | $ 6 | 1,750 | |||
Shares withheld to cover income tax obligation upon vesting of restricted stock (in shares) | (711) | |||||
Shares withheld to cover income tax obligation upon vesting of restricted stock | (41) | $ (1) | (40) | |||
Foreign currency translation gain (loss) | 941 | 941 | ||||
Net loss | (6,948) | (6,948) | ||||
Ending balance (in shares) at Mar. 31, 2021 | 24,094,051 | 408,070 | ||||
Ending balance at Mar. 31, 2021 | 72,551 | $ 215,358 | $ (2,854) | 28,427 | (172,194) | 3,814 |
Beginning balance (in shares) at Dec. 31, 2021 | 24,488,335 | 408,070 | ||||
Beginning balance at Dec. 31, 2021 | $ 50,739 | $ 219,737 | $ (2,854) | 36,584 | (206,385) | 3,657 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Stock option exercises (in shares) | 113,821 | 113,821 | ||||
Stock option exercises | $ 1,702 | $ 1,702 | ||||
Share-based compensation | 3,434 | 3,434 | ||||
Foreign currency translation gain (loss) | (2,107) | (2,107) | ||||
Net loss | (5,933) | |||||
Ending balance (in shares) at Mar. 31, 2022 | 24,602,156 | 408,070 | ||||
Ending balance at Mar. 31, 2022 | $ 47,835 | $ 221,439 | $ (2,854) | $ 40,018 | $ (212,318) | $ 1,550 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (5,933) | $ (6,948) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 953 | 908 |
Provision for doubtful accounts | 69 | 6 |
Provision for inventory obsolescence | 1,415 | 93 |
Share-based compensation | 3,434 | 1,756 |
Loss from disposal of property and equipment | 59 | 20 |
Unrealized foreign currency (gain)/ loss, net | (2,889) | 3,030 |
Amortization of right-to-use asset | 95 | 101 |
Change in fair value of derivative instruments | 396 | (230) |
Amortization of debt discount | 580 | 474 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (5,067) | (5,218) |
Inventory | (909) | (698) |
Prepaid expenses and other current assets | 69 | 1,217 |
Other assets | (636) | 26 |
Accounts payable | 2,021 | (617) |
Accrued liabilities | 1,775 | (158) |
Operating lease liabilities | (91) | (95) |
Other liabilities | (181) | (221) |
Net cash used in operating activities | (4,840) | (6,554) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (798) | (804) |
Cash used in asset acquisitions | 0 | (434) |
Cost incurred for intangible assets | (390) | (294) |
Capital expenditures on construction in progress | (4,551) | 0 |
Net cash used in investing activities | (5,739) | (1,532) |
Cash flows from financing activities: | ||
Repayments on finance leases | (7) | (55) |
Proceeds from stock option exercises | 1,702 | 1,882 |
Tax payments related to shares withheld upon vesting of restricted stock | 0 | (41) |
Net cash provided by financing activities | 1,695 | 1,786 |
Effect of exchange rate changes on cash | 125 | (273) |
Net decrease in cash | (8,759) | (6,573) |
Cash at beginning of period | 53,415 | 84,523 |
Cash at end of period | 44,656 | 77,950 |
Supplemental disclosures: | ||
Cash paid for interest | 1,707 | 1,710 |
Cash paid for income taxes | 159 | 10 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Unpaid balance for property and equipment | 51 | 143 |
Consideration payable related to asset acquisition | $ 536 | $ 407 |
Formation and Business of the C
Formation and Business of the Company | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Formation and Business of the Company | Formation and Business of the Company Establishment Labs Holdings Inc. and its wholly owned subsidiaries (collectively “the Company”) is a global company that manufactures and markets innovative medical devices for aesthetic and reconstructive plastic surgery. The Company was established in the British Virgin Islands on October 9, 2013, at which time Establishment Labs, S.A., the Costa Rican manufacturing company, was reincorporated as a wholly-owned subsidiary. As of March 31, 2022, the Company also has wholly-owned subsidiaries in the United States (JAMM Technologies, Inc. and Motiva USA LLC), Brazil (Establishment Labs Produtos para Saude Ltda), Belgium (European Distribution Center Motiva BVBA), France (Motiva Implants France SAS), Sweden (Motiva Nordica AB), Switzerland (JEN-Vault AG), the United Kingdom (Motiva Implants UK Limited), Italy (Motiva Italy S.R.L), Spain (Motiva Implants Spain, S.L.), Austria (Motiva Austria GmbH), Germany (Motiva Germany GmbH) and Argentina (Motiva Argentina S.R.L). Substantially all of the Company’s revenues are derived from the sale of silicone gel-filled breast implants, branded as Motiva Implants. The main manufacturing activities are conducted at two manufacturing facilities in Costa Rica. In 2010, the Company began operating under the Costa Rica free zone regime (Régimen de Zona Franca), which provides for reduced income tax and other tax obligations pursuant to an agreement with the Costa Rican authorities. The Company’s products are approved for sale in Europe, the Middle East, Latin America, and Asia. The Company sells its products internationally through a combination of distributors and direct sales to customers. The Company is pursuing regulatory approval to commercialize its products in the United States. The Company received approval for an investigational device exemption, or IDE, from the United States Food and Drug Administration, or FDA, in March 2018 to initiate a clinical trial in the United States for its Motiva Implants. In August 2019, the Company completed all patient surgeries for the IDE aesthetic cohorts, which include primary augmentation and revision. In the fourth quarter of 2021, the Company initiated a modular pre-market approval, or PMA, submission process with the FDA and submitted the first of four expected modules. As of March 31, 2022, the Company is continuing to enroll subjects in the remaining reconstruction cohort. In April 2022, the Company released preliminary results of the two-year patient follow-up data for the primary augmentation cohort of its IDE clinical trial. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2022 as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company’s audited consolidated financial statements as of December 31, 2021 and 2020 and for the years ended 2021, 2020 and 2019. Below are those policies with current period updates. Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the applicable rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the years ended December 31, 2021, 2020 and 2019 presented in the Company’s Form 10-K filed with the SEC on March 1, 2022. The condensed consolidated financial statements include the Company’s accounts and those of its wholly owned subsidiaries as of March 31, 2022 as follows: Subsidiary Incorporation/Acquisition Date Establishment Labs, S.A. (Costa Rica) January 18, 2004 Motiva USA, LLC (USA) February 20, 2014 JAMM Technologies, Inc. (USA) October 27, 2015 Establishment Labs Produtos par Saude Ltda (Brazil) January 4, 2016 European Distribution Center Motiva BVBA (Belgium) March 4, 2016 Motiva Implants France SAS (France) September 12, 2016 JEN-Vault AG (Switzerland) November 22, 2016 Motiva Nordica AB (Sweden) November 2, 2017 Motiva Implants UK Limited (the United Kingdom) July 31, 2018 Motiva Italy S.R.L (Italy) July 31, 2018 Motiva Implants Spain, S.L. (Spain) January 3, 2019 Motiva Austria GmbH (Austria) January 14, 2019 Motiva Germany GmbH (Germany) August 1, 2019 Motiva Argentina S.R.L (Argentina) February 7, 2020 All intercompany accounts and transactions have been eliminated in consolidation. Unaudited Interim Condensed Consolidated Financial Information The accompanying interim condensed consolidated financial statements as of March 31, 2022 and for the three months ended March 31, 2022 and 2021, and the related interim information contained within the notes to the condensed consolidated financial statements, are unaudited. The unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP and on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to state fairly the Company’s financial position as of March 31, 2022, and the results of its operations and cash flows for the three months ended March 31, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results for the three months ended March 31, 2022 are not necessarily indicative of the results to be expected for the full fiscal year 2022, or for any future period. Segments The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The Company and its Chief Executive Officer evaluate performance based primarily on revenue in the geographic regions in which the Company operates. Geographic Concentrations The Company derives all its revenues from sales to customers in Europe, the Middle East, Latin America, and Asia, and has not yet received approval to sell its products in the United States. For the three months ended March 31, 2022 and 2021, Brazil accounted for 17.4% and 10.6%, respectively, of consolidated revenue and no other individual country exceeded 10% of consolidated revenue, on a ship-to destination basis. The majority of the Company’s consolidated total assets, including cash and tangible assets, is held in the United States. The Company’s long-lived assets, which primarily consist of property and equipment and intangible assets located in Costa Rica represented 88% and 84% of the total long-lived assets as of March 31, 2022 and December 31, 2021, respectively. Use of Estimates The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Significant accounting estimates and management judgments reflected in the condensed consolidated financial statements include items such as accounts receivable valuation and allowances, inventory valuation and allowances, valuation of acquired intangible assets, valuation of derivatives and valuation of deferred income tax assets, including tax valuation allowances. Estimates are based on historical experience, where applicable, and other assumptions believed to be reasonable by management. Actual results may differ from those estimates under different assumptions or conditions. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash and accounts receivable. The majority of the Company’s cash is held at two financial institutions in the United States. Balances in the Company’s cash accounts exceed the Federal Deposit Insurance Corporation, or FDIC, limit of $250,000. The Company has not experienced any losses to its deposits of cash. All of the Company’s revenue has been derived from sales of its products in international markets, principally Europe, the Middle East, Latin America, and Asia. In the international markets in which the Company operates, the Company uses a combination of distributors and makes direct sales to customers. The Company performs ongoing credit evaluations of its distributors and customers, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary. Substantially all of the Company’s revenues were derived from the sale of Motiva Implants. During the three months ended March 31, 2022 and 2021, no customer accounted for more than 10% of the Company’s revenue. No customers accounted for more than 10% of the Company’s trade accounts receivable balance as of March 31, 2022. One customer accounted for 11.8% of the Company’s trade accounts receivable balance as of December 31, 2021 . The Company relies on NuSil Technology, LLC, or NuSil, as the sole supplier of medical-grade silicone used in Motiva Implants. During the three months ended March 31, 2022 and 2021, the Company had purchases of $7.3 million, or 31.4% of total purchases, and $4.3 million, or 55.8% of total purchases, respectively, from NuSil. As of March 31, 2022 and December 31, 2021 , the Company had an outstanding balance owed to this vendor of $2.7 million and $2.5 million, respectively. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of regulatory approval of the Company’s current and potential future products, uncertainty of market acceptance of the Company’s products, competition from substitute products and larger companies, securing and protecting proprietary technology, access to capital, strategic relationships and dependence on key individuals and sole source suppliers. Products developed by the Company require clearances from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary clearances. If the Company is denied clearance, clearance is delayed, or the Company is unable to maintain its existing clearances, these developments could have a material adverse impact on the Company. The COVID-19 outbreak caused a material disruption of the operations of the Company and its suppliers and customers in fiscal 2020 and, to a lesser degree, in fiscal 2021 and resulted in delayed clinical trial enrollment within the reconstruction cohort of its IDE clinical trial in the United States. However, to date, the impact from the COVID-19 outbreak has not had a material effect on the Company’s liquidity or financial position. The full extent of any future impact of the continuing outbreak, related business and travel restrictions, and changes to behavior intended to reduce its spread is uncertain and continues to evolve globally. Management continues to monitor the impact that the COVID-19 pandemic is having on the Company, the breast aesthetics and reconstruction market and the economies in which the Company operates. Cash The Company’s cash consists of cash maintained in checking and interest-bearing accounts. The majority of the Company’s cash is held at two financial institutions in the United States. The Company accounts for financial instruments with original maturities of three months or less at the date of purchase as cash equivalents. The Company held no cash equivalents as of March 31, 2022 or December 31, 2021 . Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable is stated at invoice value less estimated allowances for returns and doubtful accounts. The Company continually monitors customer payments and maintains an allowance for estimated losses resulting from customers’ inability to make required payments. In evaluating the Company’s ability to collect outstanding receivable balances, the Company considers various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition. In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable to the amount reasonably believed to be collectible. Inventory and Cost of Revenue Inventory is stated at the lower of cost to purchase or manufacture the inventory or the net realizable value of such inventory. Cost is determined using the standard cost method which approximates actual costs using the first-in, first-out basis. The Company regularly reviews inventory quantities considering actual losses, projected future demand, and remaining shelf life to record a provision for excess and slow-moving inventory. An inventory reserve of $2.6 million and $1.2 million has been recorded as of March 31, 2022 and December 31, 2021, respectively. The Company recognizes the cost of inventory transferred to the customer in cost of revenue when revenue is recognized. Leases The Company determines if an arrangement is, or contains, a lease at the inception date of the contract. The Company has elected an expedient to account for each separate lease component and its associated non-lease components as a single lease component for the majority of its asset classes. The lease term may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise a renewal option, or reasonably certain it will not exercise an early termination option. The Company recognizes lease liabilities and right-of-use, or ROU, assets upon commencement for all material leases with a term greater than 12 months. The Company has elected an expedient not to recognize leases with a lease term of 12 months or less on the balance sheet. These short-term leases are expensed on a straight-line basis over the lease term. Shipping and Handling Costs Shipping and handling costs are expensed as incurred and are included in selling, general and administrative, or SG&A, expenses. For the three months ended March 31, 2022 and 2021, shipping and handling costs were $1.4 million and $1.2 million, respectively. Revenue Recognition The Company recognizes revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances. The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC, Revenue from Contracts with Customers (Topic 606). ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. The Company recognizes revenue related to the sales of products to distributors at the time of shipment of the product, which represents the point in time when the distributor has taken ownership and assumed the risk of loss, and the required revenue recognition criteria are satisfied. The Company’s distributors are obligated to pay within specified terms regardless of when, or if, they sell the products. The Company’s contracts with distributors typically do not contain right of return or price protection and have no post-delivery obligations. The Company recognizes revenue when title to the product and risk of loss transfer to customers, provided there are no remaining performance obligations required of the Company or any written matters requiring customer acceptance. The Company allows for the return of product from direct customers in certain regions in limited instances within fifteen days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized. Appropriate reserves are established for anticipated sales returns based on historical experience, recent gross sales and any notification of pending returns. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period is recorded. As of March 31, 2022 and December 31, 2021 , an allowance of $3,000 and $10,000 was recorded for product returns, respectively. A portion of the Company’s revenue is generated from the sale of consigned inventory maintained at physician, hospital, or clinic locations. For these products, revenue is recognized at the time the Company is notified by the consignee that the product has been implanted, not when the consigned products are delivered to the consignee’s warehouse. Revenue was generated in these primary geographic markets: Three Months Ended March 31, 2022 2021 (in thousands) Europe $ 14,339 $ 12,693 Latin America 12,186 8,001 Asia-Pacific/Middle East 11,620 9,495 Other 307 147 $ 38,452 $ 30,336 The Company has a limited warranty for the shelf life of breast implants, which is five years from the time of manufacture. Estimated warranty obligations are recorded at the time of sale. The Company also offers a warranty to patients in the event of rupture and a replacement program for capsular contracture events, provided certain registration requirements are met. Revenue for extended warranties is recognized ratably over the term of the agreement. To date, these warranty and program costs have been de minimis. The Company will continue to evaluate the warranty reserve policies for adequacy considering claims history. Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. The Company has received payments from distributors to provide distribution exclusivity within a geographic area and recognizes deferred revenue on a ratable basis over the term of such contractual distribution relationship. Additionally, the Company has received payments from customers in direct markets prior to surgical implantation and recognizes deferred revenue at the time the Company is notified by the customer that the product has been implanted. For all arrangements, any revenue that has been deferred and is expected to be recognized beyond one year is classified as long-term deferred revenue and included in “Other liabilities, long-term” on the condensed consolidated balance sheets (see Note 3). Research and Development Costs related to research and development, or R&D, activities are expensed as incurred. R&D costs primarily include personnel costs, materials, clinical expenses, regulatory expenses, product development, consulting services, and outside research activities, all of which are directly related to research and development activities. The Company estimates IDE clinical trial expenses based on the services performed, pursuant to contracts with research institutions and clinical research organizations that conduct and manage clinical trials on its behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of patient enrollment and activity expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. Selling, General and Administrative Expenses SG&A expenses include sales and marketing costs, payroll and related benefit costs, insurance expenses, shipping and handling costs, legal and professional fees and administrative overhead. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Following the exercise of its option to purchase its manufacturing facility in June 2019, the Company depreciates the owned building on a straight-line basis over 50 years of useful life. Depreciation of property and equipment is computed using the straight-line method over the assets’ estimated useful lives of five Goodwill and Intangible Assets The Company records the excess of the acquisition purchase price over the net fair value of the tangible and identifiable intangible assets acquired and liabilities assumed as goodwill. In accordance with ASC 350, Intangibles - Goodwill and Other, the Company tests goodwill for impairment annually during the fourth quarter of each year and whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. In connection with the annual impairment test for goodwill, the Company elected the option to perform a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If the Company determines that it was more likely than not that the fair value of the reporting unit is less than its carrying amount, then the impairment test is performed. Consistent with the Company's assessment that it has only one reporting segment, the Company has determined that it has only one reporting unit and tests goodwill for impairment at the entity level using the two-step process required by ASC 350. In the first step, the Company compares the carrying amount of the reporting unit to the fair value of the enterprise. If the fair value of the enterprise exceeds the carrying value, goodwill is not considered impaired and no further testing is required. If the carrying value of the enterprise exceeds the fair value, goodwill is potentially impaired, and the second step of the impairment test must be performed. In the second step, the Company compares the implied fair value of the goodwill, as defined by ASC 350, to its carrying amount to determine the impairment loss, if any. The Company capitalizes certain costs related to intangible assets, such as patents, trademarks and software development costs. The Company follows the provisions of ASC 350-40, Internal Use Software for determining whether computer software is internal-use software and on accounting for the proceeds of computer software originally developed or obtained for internal use. The Company expenses all costs incurred during the preliminary project stage of software development and capitalizes the costs incurred during the application development stage. Costs incurred relating to upgrades and enhancements to the software are capitalized if it is determined that these upgrades or enhancements add additional functionality to the software. Costs incurred to improve and support products after they become available are charged to expense as incurred. The Company records purchased intangible assets at their respective estimated fair values at the date of acquisition. Purchased finite-lived intangible assets are being amortized using the straight-line method over their remaining estimated useful lives, which range from two During the year ended December 31, 2021, there was no impairment of goodwill or intangible assets based on the qualitative assessments performed by the Company. As of March 31, 2022, no triggering events have occurred which would indicate that the acquired intangible asset values may not be recoverable. Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. When such an event occurs, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the related asset group’s carrying value. If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded d uring the year ended December 31, 2021. As of March 31, 2022, no triggering events have occurred which would indicate that the acquired long-lived asset values may not be recoverable. Debt and Embedded Derivatives The Company applies the accounting standards for derivatives and for distinguishing liabilities from equity when accounting for hybrid contracts. The Company accounts for convertible debt instruments when the Company has determined that the embedded conversion options should not be bifurcated from their host instruments in accordance with ASC 470-20 Debt with Conversion and Other Options (see Note 6). The Company uses option pricing valuation models to determine the fair value of embedded derivatives and records any change in fair value as a component of other income or expense in the condensed consolidated statements of operations (see Note 5). Debt Issuance Costs and Debt Discounts Costs incurred in connection with the issuance of new debt are capitalized. Capitalizable debt issuance costs paid to third parties and debt discounts, net of amortization, are recorded as a reduction to the long-term debt balance on the condensed consolidated balance sheets. Amortization expense on capitalized debt issuance costs and debt discounts related to loans are calculated using the effective interest method over the term of the loan commitment and is recorded as interest expense in the condensed consolidated statements of operations. Income Taxes The Company records income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s consolidated financial statements or income tax returns. In estimating future tax consequences, expected future events, enactments or changes in the tax law or rates are considered. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized. The Company operates in various tax jurisdictions and is subject to audit by various tax authorities. The Company records uncertain tax positions based on a two-step process whereby (1) a determination is made as to whether it is more likely than not that the tax positions will be sustained based on the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold the Company recognizes the largest amount of tax benefit that is greater than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Significant judgment is required in the identification of uncertain tax positions and in the estimation of penalties and interest on uncertain tax positions. There were no material uncertain tax positions in fiscal 2021 or for the three months ended March 31, 2022. Foreign Currency The financial statements of the Company’s foreign subsidiaries whose functional currencies are the local currencies are translated into U.S. dollars for consolidation as follows: assets and liabilities at the exchange rate as of the balance sheet date, stockholders’ equity at the historical rates of exchange, and income and expense amounts at the average exchange rate for the period. Translation adjustments resulting from the translation of the subsidiaries’ accounts are included in “Accumulated other comprehensive income” as equity in the condensed consolidated balance sheet. Transactions denominated in currencies other than the applicable functional currency are converted to the functional currency at the exchange rate on the transaction date. At period end, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities are remeasured at historical exchange rates. Gains and losses resulting from foreign currency transactions are included within “Other income (expense), net” in the condensed consolidated statements of operations. For the three months ended March 31, 2022 foreign currency transaction gain amounted to $2.8 million compared to a foreign currency transaction loss of $2.7 million for the three months ended March 31, 2021. Comprehensive Loss The Company’s comprehensive loss consists of net loss and foreign currency translation adjustments arising from the consolidation of the Company’s foreign subsidiaries. Share-Based Compensation The Company measures and recognizes compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation . Share-based awards granted include stock options, restricted stock units, or RSUs, and restricted stock awards, or RSAs. Share-based compensation expense for stock options and restricted stock granted to employees is measured at the grant date based on the fair value of the awards and is recognized as an expense ratably on a straight-line basis over the requisite service period. The fair value of options to purchase shares granted to employees is estimated on the grant date using the Black-Scholes option valuation model. The calculation of share-based compensation expense requires the Company to make assumptions and judgments about the variables used in the Black-Scholes model, including the expected term, expected volatility of the underlying common shares, risk-free interest rate and dividends. Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing the net income (loss) attributable to shareholders by the weighted-average number of shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, any shares issuable upon exercise of warrants, stock options and non-vested restricted stock outstanding under the Company’s equity plan are potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for periods where the Company reported a net loss because including the dilutive securities would be anti-dilutive. Recent Accounting Standards Periodically, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Previously, under the Jumpstart Our Business Startups Act of 2012, or JOBS Act, the Company met the definition of an emerging growth company, and previously elected the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. The Company ceased to be an emerging growth company on December 31, 2021. The following recent accounting pronouncements issued by the FASB could have a material effect on the Company’s financial statements: Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) . The new guidance eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. This standard is currently effective. The Company adopted ASU 2019-12 as of January 1, 2022. The adoption did not have a material impact upon the Company’s financial position and results of operations. |
Balance Sheet Accounts
Balance Sheet Accounts | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Accounts | Balance Sheet Accounts Inventory, Net March 31, December 31, (in thousands) Raw materials $ 7,609 $ 8,519 Work in process 1,861 1,396 Finished goods 19,068 18,492 $ 28,538 $ 28,407 As of March 31, 2022 and December 31, 2021, $4.2 million and $3.5 million of inventory was on consignment, respectively. Prepaid Expenses and Other Current Assets March 31, December 31, (in thousands) Prepaid insurance $ 2,082 $ 2,315 Prepaid raw materials and accessories 386 577 Prepaid warranty and distribution rights 174 516 Prepaid U.S. clinical trial costs 761 412 Prepaid taxes 735 551 Other 2,995 2,641 $ 7,133 $ 7,012 Property and Equipment, Net March 31, December 31, (in thousands) Machinery and equipment $ 10,442 $ 10,240 Construction in process 7,725 3,174 Building improvements 6,804 6,713 Furniture and fixtures 5,126 4,761 Building 2,472 2,472 Leasehold improvements 2,192 2,118 Land 802 802 Vehicles 272 268 Total 35,835 30,548 Less: Accumulated depreciation and amortization (12,534) (11,890) $ 23,301 $ 18,658 For each of the three months ended March 31, 2022 and 2021, depreciation and amortization expense related to property and equipment was $0.6 million. The Company entered into finance leases relating to equipment and vehicles and recorded the fair value of the lease payments on the initial contract date and is amortizing the assets over the term of the leases. As of each of March 31, 2022 and December 31, 2021 the gross asset value for finance lease assets was $1.4 million. Depreciation expense for assets under finance leases was $25,000 and $43,000 for the three months ended March 31, 2022 and 2021, respectively . In August 2021, the Company entered into a contract with the Zona Franca Coyol, S.A., or CFZ, to begin construction of a new manufacturing facility in Costa Rica. The costs for improvement of the land and construction of a cold shell building are being paid for by CFZ while the Company is paying for internal improvements and customization. Upon completion, the Company will have the option to purchase the title to the land and cold shell building for approximately $12.6 million or to lease the facility at a to be determined price. Subject to purchase of the land and cold shell building, the Company will have the option to buy an adjacent lot of land for approximately $2.8 million and engage CFZ to construct an additional manufacturing facility. Accrued Liabilities Accrued liabilities consisted of the following: March 31, December 31, (in thousands) Performance bonus $ 4,495 $ 3,346 Payroll and related expenses 4,342 3,904 Bonus feature of stock option grants 5,968 5,570 Operating lease liabilities - current 405 402 Commissions 951 1,138 Professional and legal services 914 819 Warranty reserve 170 167 Cash payable for asset acquisitions - contingent consideration — 137 Other 812 753 $ 18,057 $ 16,236 Other Liabilities, Short-Term Other liabilities, short-term consisted of the following: March 31, December 31, (in thousands) Deferred revenue $ 1,266 $ 769 Cash payable for asset acquisitions 536 409 $ 1,802 $ 1,178 Other Liabilities, Long-Term Other liabilities, long-term consisted of the following: March 31, December 31, (in thousands) Deferred revenue $ 1,821 $ 2,392 |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Other Intangible Assets | Goodwill and Other Intangible AssetsGoodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. Intangible assets resulting from the acquisitions of entities accounted for using the acquisition method of accounting are recorded at the estimated fair value of the assets acquired. Purchased intangibles include certain patents and license rights, 510(k) authorization by the FDA to sell a medical device and other intangible assets. The Company’s goodwill and most intangibles at March 31, 2022 are the result of previous asset and business acquisitions. Finite-lived intangibles are amortized over their estimated useful lives based on expected future benefit. In addition to the intangibles acquired, the Company capitalized certain patent and license rights as identified intangibles based on patent and license rights agreements entered into over the past several years. Additionally, the Company capitalized certain software development costs. There were no changes in the carrying amount of goodwill during the three months ended March 31, 2022: Balance as of January 1, 2022 Additions Accumulated Impairment Losses Balance as of March 31, 2022 (in thousands) Goodwill $ 465 $ — $ — $ 465 The carrying amounts of these intangible assets other than goodwill as of March 31, 2022 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,757 $ (1,179) $ 578 7-12 Customer relationships 2,033 (1,849) 184 4-10 510(k) authorization 567 (241) 326 15 Developed technology 62 (53) 9 10 Capitalized software development costs 4,010 (971) 3,039 2-5 Other 75 (32) 43 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,795 $ (4,325) $ 4,470 The carrying amounts of intangible assets other than goodwill as of December 31, 2021 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,736 $ (1,136) $ 600 7-12 Customer relationships 2,033 (1,799) 234 4-10 510(k) authorization 567 (232) 335 15 Developed technology 62 (52) 10 10 Capitalized software development costs 3,648 (791) 2,857 2-5 Other 75 (31) 44 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,412 $ (4,041) $ 4,371 The amortization expense associated with intangible assets was $0.3 million for each of the three months ended March 31, 2022 and 2021 . Non-product related amortization is recorded in SG&A while product related amortization is recorded in cost of revenue. As of March 31, 2022, the amortization expense related to identifiable intangible assets, with definite useful lives, in future periods is expected to be as follows: Year Ending December 31, (in thousands) 2022 (remaining) $ 902 2023 931 2024 857 2025 689 2026 403 Thereafter 397 Total $ 4,179 The Company evaluates the recoverability of goodwill and indefinite-lived intangible assets annually and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. During the year ended December 31, 2021, there was no impairment of goodwill or intangible assets based on the qualitative assessments performed by the Company. As of March 31, 2022, no triggering events have occurred which would indicate that the acquired intangible asset values may not be recoverable. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The carrying value of the Company’s cash, accounts receivable and accounts payable approximate fair value due to the short-term nature of these items. Embedded derivatives that qualify for liability treatment are carried at fair value and re-measured at each reporting period. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: • Level I Unadjusted quoted prices in active markets for identical assets or liabilities; • Level II Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level III Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy at period end: Fair Value Measurements at March 31, 2022 Total Level 1 Level 2 Level 3 (in thousands) Liabilities Madryn put option liability $ 1,099 $ — $ — $ 1,099 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Level 3 (in thousands) Liabilities Madryn put option liability $ 703 $ — $ — $ 703 The fair value measurement of derivatives is based on significant inputs not observed in the market and thus represents a Level 3 measurement. In August 2017, the Company entered into a credit agreement, or the Madryn Credit Agreement, with Madryn Health Partners, LP, or Madryn, as administrative agent, and a syndicate of lenders (see Note 6). The Company determined that the Madryn Credit Agreement contained put options related to early redemption mandatory prepayment terms in case of change in control or an event of default and a call option related to voluntary repayment option. The Company allocated a fair value of $15.1 million for these identified embedded derivatives as a debt discount on the original commitment date. An additional $5.0 million and $1.6 million debt discount was recorded on respective borrowing dates when the Company met the required milestones and borrowed an additional $10.0 million in 2017 and $25.0 million in 2019. The Company revalued the options as of each reporting period and recorded the change in the fair value in the consolidated statements of operations as other income or expense. Valuation of the embedded derivatives is complex and requires interest rate simulation, capturing optimal decision making process as interest rate fluctuates and estimating the resultant bond valuation and the resultant pay-off to the option holder. The Company estimated the fair value of the embedded redemption options based on a “with” and “without” approach using the Black-Derman-Toy model, a form of the Binomial Lattice Model that captures interest rate variability and the prepayment optionality. The Binomial Lattice Model allows for the possibility of exercise before the end of the option’s life and considers future interest rates, volatility and other data with regards to the Company’s credit rating and credit spread. The value of the embedded derivatives was based on the difference between the “with” and “without” analysis. The probability of a change in control occurring was determined to be 50% (cumulative probability through the maturity date) at March 31, 2022 and December 31, 2021. The Company used the following assumptions to value Madryn derivatives: Madryn Put Option Liability March 31, 2022 December 31, 2021 Interest rate volatility 29.2% 25.8% Market yield rate 7.3% 6.8% Term (in years) 3.50 3.75 Dividend yield — — The estimates are based, in part, on subjective assumptions and could differ materially in the future. During the periods presented, the Company has not changed the manner in which it values liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the three months ended March 31, 2022 or during the year ended December 31, 2021. The fair value of the debt redemption feature liability includes the estimated market rate (credit spread and risk-free rate) and volatility. The higher/lower the estimated volatility, the higher/lower the value of the debt redemption feature liability. The higher/lower the estimated market rate, the higher/lower the value of the debt redemption feature liability. The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows: Madryn Put Option Liability Balance at December 31, 2021 $ 703 Change in fair value 396 Balance at March 31, 2022 $ 1,099 Balance at December 31, 2020 $ 1,440 Change in fair value (230) Balance at March 31, 2021 $ 1,210 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Madryn Debt On August 24, 2017, the Company entered into the Madryn Credit Agreement with Madryn, as administrative agent, and a syndicate of lenders that matures September 30, 2025. On August 5, 2020, the Company amended the Madryn Credit Agreement to adjust the minimum product revenue milestone previously applicable to December 31, 2020 to September 30, 2021 and to add Motiva Implants UK Limited, Motiva Implants France SAS, Motiva Implants Spain, S.L. and Motiva Germany GmbH, wholly-owned subsidiaries of the Company, as guarantors to the Madryn Credit Agreement. The Madryn Credit Agreement, as amended, provided for term loans in a maximum aggregate principal amount of $65.0 million. In connection with the Madryn Credit Agreement, the Company and certain of its subsidiaries granted a security interest in substantially all of their respective assets, including, without limitation, intellectual property, and pledges of certain shares of the Company’s subsidiaries, subject to certain excluded collateral exceptions. The Madryn Credit Agreement contained customary affirmative and negative covenants, including, but not limited to, restrictions on the ability of the Company and its subsidiaries to incur additional indebtedness, create liens, make certain investments, make restricted payments, enter into or undertake certain liquidations, mergers, consolidations or acquisitions and dispose of assets or subsidiaries. In addition, the Madryn Credit Agreement required the Company to maintain minimum revenues and liquidity. Borrowings under the Madryn Credit Agreement bore interest at a rate equal to 3-month LIBOR plus 8.0% per annum provided that no default had occurred. In an event of a default, the interest would increase by an additional 4.0% per annum. The effective interest rate under the amended Madryn Credit Agreement was 18.4%, and the weighted average interest rate was approximately 10.6% at March 31, 2022. The Company incurred $1.7 million in interest expense in connection with Madryn Credit Agreement during each of the three months ended March 31, 2022 and 2021. No principal payments were due on the term loans until the final maturity date on September 30, 2025 (see Note 14). The Company also determined that the Madryn Credit Agreement contained put options which are mandatory repayment provisions related to liquidity events or an event of default and a call option related to voluntary repayment option. The Company allocated a fair value of $15.1 million for these embedded derivatives as a debt discount on the original commitment date in August 2017. An additional $5.0 million and $1.6 million debt discount was recorded on respective borrowing dates when the Company met the required milestones and borrowed an additional $10.0 million in the fourth quarter of fiscal 2017 and $25.0 million in August 2019. The Company revalued the embedded derivatives as of each reporting period and recorded the change in the fair value in the consolidated statements of operations as other income or expense (see Note 5). The Company recorded Madryn debt on the balance sheet as follows: March 31, December 31, (in thousands) Principal $ 65,000 $ 65,000 Net unamortized debt discount and issuance costs (12,514) (13,094) Net carrying value of Madryn debt $ 52,486 $ 51,906 As of March 31, 2022, the Company was in compliance with all financial debt covenants. On April 26, 2022, the Company entered into a Credit Agreement and Guaranty, or the Credit Agreement, together with certain of its subsidiaries party thereto as guarantors, the lenders from time to time party thereto, or the Lenders, and Oaktree Fund Administration, LLC, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”), pursuant to which the Lenders agreed to make term loans to the Company in an aggregate principal amount of up to $225 million with a first tranche of $150 million advanced on April 26, 2022. A portion of the first tranche was used to repay the outstanding principal and interest under the Madryn Credit Agreement in full, including the early repayment penalty of $6.5 million (see Note 14). |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company recognizes lease liabilities and ROU assets upon commencement for all material leases with a term greater than 12 months. The Company has elected an expedient not to recognize leases with a lease term of 12 months or less on the balance sheet. These short-term leases are expensed on a straight-line basis over the lease term. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at commencement date of the lease based on the present value of lease payments over the lease term. When the rate implicit to the lease cannot be readily determined, the Company utilizes its incremental borrowing rate in determining the present value of the future lease payments. Lease liabilities are accreted each period and reduced for payments. The ROU asset also includes other adjustments, such as for the effects of escalating rents, rent abatements or initial lease costs. The lease term may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise a renewal option, or reasonably certain it will not exercise an early termination option. For operating leases, lease expense for minimum lease payments is recognized on a straight-line basis over the expected lease term. For finance leases, the ROU asset depreciates on a straight-line basis over the shorter of the lease term or useful life of the ROU asset and the lease liability accretes interest based on the interest method using the discount rate determined at lease commencement. The Company has operating leases for facilities and office space as well as finance leases for equipment and vehicles. Operating lease assets and the related lease liabilities are included within the ROU assets—operating leases. The determination of whether an arrangement is, or contains, a lease is performed at the inception of the arrangement. The Company has operating and finance leases for certain facilities, office space, equipment, and vehicles to be used in its operations, with remaining lease terms ranging from monthly to 7 years. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease for additional years. These optional periods have not been considered in the determination of the ROU or lease liabilities associated with these leases as management did not consider it reasonably certain it would exercise the options. Short-term leases, which have an initial term of 12 months or less, are not recorded in the balance sheet and expense for these leases is recognized on a straight-line basis over the lease term. The Company’s lease agreements do not contain any termination options, material residual value guarantees, material bargain purchase options or material restrictive covenants. The Company does not have any lease transactions with related parties. Total lease cost includes the following components for the three months ended March 31, 2022 and 2021, as well as for the year ended December 31, 2021: March 31, March 31, (in thousands) Operating lease expense cost $ 147 $ 167 Finance lease costs Interest expense 1 3 Amortization expense 25 35 Total finance lease costs $ 26 $ 38 March 31, December 31, 2021 Supplemental balance sheet information (in thousands) Operating leases Operating lease right-of-use assets $ 2,113 $ 2,206 Operating lease liabilities - short-term 405 402 Operating lease liabilities - long-term 1,805 1,900 Total operating lease liabilities $ 2,210 $ 2,302 Finance leases Finance lease right-of-use assets $ 187 $ 154 Finance lease liabilities - short-term 12 13 Finance lease liabilities - long-term 30 — Total finance lease liabilities $ 42 $ 13 Weighted-average remaining lease term (years) Operating leases 5.2 5.5 Finance leases 4.0 0.8 Weighted-average discount rate (%) Operating leases 10.4 % 10.4 % Finance leases 8.2 % 8.3 % March 31, March 31, Cash paid for amounts included in the measurement of lease liabilities (in thousands) Operating cash outflows from operating leases $ 147 $ 160 Operating cash outflows from finance leases $ 1 $ 3 Financing cash outflows from finance leases $ 7 $ 55 ROU assets obtained in exchange for new lease liabilities Operating leases $ — $ — Finance leases $ 36 $ — Maturities of lease liabilities as of March 31, 2022 were as follows: Years Ending December 31, Operating Leases Finance Leases (in thousands) 2022 $ 416 $ 14 2023 535 9 2024 504 9 2025 429 9 2026 404 9 Thereafter 436 — Total future minimum lease payments 2,724 50 Less: Amount of lease payments representing interest (514) (8) Present value of future minimum lease payments $ 2,210 $ 42 |
Leases | Leases The Company recognizes lease liabilities and ROU assets upon commencement for all material leases with a term greater than 12 months. The Company has elected an expedient not to recognize leases with a lease term of 12 months or less on the balance sheet. These short-term leases are expensed on a straight-line basis over the lease term. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at commencement date of the lease based on the present value of lease payments over the lease term. When the rate implicit to the lease cannot be readily determined, the Company utilizes its incremental borrowing rate in determining the present value of the future lease payments. Lease liabilities are accreted each period and reduced for payments. The ROU asset also includes other adjustments, such as for the effects of escalating rents, rent abatements or initial lease costs. The lease term may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise a renewal option, or reasonably certain it will not exercise an early termination option. For operating leases, lease expense for minimum lease payments is recognized on a straight-line basis over the expected lease term. For finance leases, the ROU asset depreciates on a straight-line basis over the shorter of the lease term or useful life of the ROU asset and the lease liability accretes interest based on the interest method using the discount rate determined at lease commencement. The Company has operating leases for facilities and office space as well as finance leases for equipment and vehicles. Operating lease assets and the related lease liabilities are included within the ROU assets—operating leases. The determination of whether an arrangement is, or contains, a lease is performed at the inception of the arrangement. The Company has operating and finance leases for certain facilities, office space, equipment, and vehicles to be used in its operations, with remaining lease terms ranging from monthly to 7 years. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease for additional years. These optional periods have not been considered in the determination of the ROU or lease liabilities associated with these leases as management did not consider it reasonably certain it would exercise the options. Short-term leases, which have an initial term of 12 months or less, are not recorded in the balance sheet and expense for these leases is recognized on a straight-line basis over the lease term. The Company’s lease agreements do not contain any termination options, material residual value guarantees, material bargain purchase options or material restrictive covenants. The Company does not have any lease transactions with related parties. Total lease cost includes the following components for the three months ended March 31, 2022 and 2021, as well as for the year ended December 31, 2021: March 31, March 31, (in thousands) Operating lease expense cost $ 147 $ 167 Finance lease costs Interest expense 1 3 Amortization expense 25 35 Total finance lease costs $ 26 $ 38 March 31, December 31, 2021 Supplemental balance sheet information (in thousands) Operating leases Operating lease right-of-use assets $ 2,113 $ 2,206 Operating lease liabilities - short-term 405 402 Operating lease liabilities - long-term 1,805 1,900 Total operating lease liabilities $ 2,210 $ 2,302 Finance leases Finance lease right-of-use assets $ 187 $ 154 Finance lease liabilities - short-term 12 13 Finance lease liabilities - long-term 30 — Total finance lease liabilities $ 42 $ 13 Weighted-average remaining lease term (years) Operating leases 5.2 5.5 Finance leases 4.0 0.8 Weighted-average discount rate (%) Operating leases 10.4 % 10.4 % Finance leases 8.2 % 8.3 % March 31, March 31, Cash paid for amounts included in the measurement of lease liabilities (in thousands) Operating cash outflows from operating leases $ 147 $ 160 Operating cash outflows from finance leases $ 1 $ 3 Financing cash outflows from finance leases $ 7 $ 55 ROU assets obtained in exchange for new lease liabilities Operating leases $ — $ — Finance leases $ 36 $ — Maturities of lease liabilities as of March 31, 2022 were as follows: Years Ending December 31, Operating Leases Finance Leases (in thousands) 2022 $ 416 $ 14 2023 535 9 2024 504 9 2025 429 9 2026 404 9 Thereafter 436 — Total future minimum lease payments 2,724 50 Less: Amount of lease payments representing interest (514) (8) Present value of future minimum lease payments $ 2,210 $ 42 |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Under the Memorandum of Association and Articles of Association, or Articles, in effect as of March 31, 2022 and December 31, 2021, the Company had authorized an unlimited number of common shares with no par value. As of March 31, 2022 and December 31, 2021, 24,602,156 and 24,488,335 common shares, respectively, were issued and 24,194,086 and 24,080,265 common shares, respectively, were outstanding. During the three months ended March 31, 2022, the Company granted stock options and RSUs to employees (see Note 10). The Company had reserved common shares for future issuances as follows: March 31, December 31, Warrants to purchase common shares 5,500 5,500 Options to purchase common shares 1,956,119 2,098,087 Remaining shares available under the 2018 Equity Incentive Plan 2,558,834 1,780,687 Shares issuable on vesting of grants of RSUs 21,025 3,982 Remaining shares available under the 2018 ESPP 848,000 661,000 Total 5,389,478 4,549,256 In March 2017, the Company issued warrants for the purchase of 145,000 Class B ordinary shares to parties related to Rockport Ventures, with a fixed exercise price of $3.80 per share. During the three months ended March 31, 2022, no warrants were exercised. As of each of March 31, 2022 and December 31, 2021, 5,500 warrants to purchase the Company’s common shares were outstanding and exercisable: Warrant Holder Issue Date In Connection With Warrant to Purchase Shares Exercise Price Expiration Date Rockport 3/3/2017 Loan agreement Common 5,500 $ 3.80 8/28/2022 |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Warrants | Shareholders’ Equity Under the Memorandum of Association and Articles of Association, or Articles, in effect as of March 31, 2022 and December 31, 2021, the Company had authorized an unlimited number of common shares with no par value. As of March 31, 2022 and December 31, 2021, 24,602,156 and 24,488,335 common shares, respectively, were issued and 24,194,086 and 24,080,265 common shares, respectively, were outstanding. During the three months ended March 31, 2022, the Company granted stock options and RSUs to employees (see Note 10). The Company had reserved common shares for future issuances as follows: March 31, December 31, Warrants to purchase common shares 5,500 5,500 Options to purchase common shares 1,956,119 2,098,087 Remaining shares available under the 2018 Equity Incentive Plan 2,558,834 1,780,687 Shares issuable on vesting of grants of RSUs 21,025 3,982 Remaining shares available under the 2018 ESPP 848,000 661,000 Total 5,389,478 4,549,256 In March 2017, the Company issued warrants for the purchase of 145,000 Class B ordinary shares to parties related to Rockport Ventures, with a fixed exercise price of $3.80 per share. During the three months ended March 31, 2022, no warrants were exercised. As of each of March 31, 2022 and December 31, 2021, 5,500 warrants to purchase the Company’s common shares were outstanding and exercisable: Warrant Holder Issue Date In Connection With Warrant to Purchase Shares Exercise Price Expiration Date Rockport 3/3/2017 Loan agreement Common 5,500 $ 3.80 8/28/2022 |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Compensation | Share-Based Compensation In 2015, the Board of Directors approved and adopted the 2015 Equity Incentive Plan, or 2015 Plan. Pursuant to the 2015 Plan, the Company granted RSAs and stock options to members of the Board of Directors, employees and consultants. In 2018, the Board of Directors terminated the 2015 Plan and approved the 2018 Equity Incentive Plan, or the 2018 Plan, with an initial reserve of 1,500,000 common shares. Under the 2018 Plan, the Company may grant stock options, equity appreciation rights, RSUs and RSAs. If an award granted under the 2018 Plan expires, terminates, is unexercised, or is forfeited, or if any shares are surrendered in connection with an incentive award, the shares subject to such award and the surrendered shares become available for further awards under the 2018 Plan. Pursuant to the “evergreen” provision contained in the 2018 Plan, the number of common shares reserved for issuance under the 2018 Plan automatically increases on first day of each fiscal year, commencing on January 1, 2019, in an amount equal to the least of (1) 750,000 shares, (2) 4% of the total number of the Company’s common shares outstanding on the last day of the preceding fiscal year, or (3) a number of common shares as may be determined by the Company’s Board of Directors prior to any such increase date. On each of January 1, 2019, 2020, 2021 and 2022 the number of common shares authorized for issuance increased automatically by 750,000 shares in accordance with the evergreen provision, increasing the number of common shares reserved under the 2018 Plan to 4,500,000 as of March 31, 2022. During the periods presented, the Company recorded the following share-based compensation expense for stock options and restricted stock awards: Three Months Ended March 31, 2022 2021 (in thousands) Sales, general and administrative $ 2,967 $ 1,146 Research and development 467 611 Total $ 3,434 $ 1,757 Stock Options Number of Options Outstanding Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Balances at December 31, 2021 2,098,087 $ 37.49 7.67 $ 67,357 Granted (weighted-average fair value $45.54 per share) 11,045 33.44 Exercised (113,821) 14.96 Forfeited/canceled (39,192) 33.02 Balances at March 31, 2022 1,956,119 $ 38.87 7.55 $ 60,107 As of March 31, 2022, 894,656 options were vested and exercisable with weighted-average exercise price of $21.26 per share and a total aggregate intrinsic value of $41.5 million. During the three months ended March 31, 2022, 113,821 options were exercised at a weighted-average price of $14.96 per share. The intrinsic value of the options exercised during the three months ended March 31, 2022 and 2021 was $5.0 million and $7.3 million, respectively. Upon the exercise of stock options, the Company issued new shares from its authorized shares. At March 31, 2022, unrecognized compensation expense was $24.8 million related to stock options granted to employees and members of the Board of Directors and $1.0 million related to stock options granted to consultants. The weighted-average period over which such compensation expense will be recognized is 2.3 years. Stock Options Granted to Employees Share-based compensation expense for employees is based on the grant date fair value. The Company recognizes compensation expense for all share-based awards ratably on a straight-line basis over the requisite service period of the awards, which is generally the vesting term of four years. During the three months ended March 31, 2022 and 2021, the Company recognized $2.9 million and $1.1 million, respectively, of share-based compensation expense for stock options granted to employees. The Company uses the Black-Scholes option valuation model to value options granted to employees and consultants, which requires the use of highly subjective assumptions to determine the fair value of share-based awards. The assumptions used in the Company’s option-pricing model represent management’s best estimates. These estimates are complex, involve a number of variables, uncertainties and assumptions and the application of management’s judgment. If factors change and different assumptions are used, the Company’s share-based compensation expense could be materially different in the future. The assumptions and estimates that the Company uses in the Black-Scholes model are as follows: ▪ Fair Value of Common Shares. The closing price of the Company’s publicly-traded common shares on the date of grant is used as the fair value of the shares. The Board of Directors intended all options granted to be exercisable at a price per share not less than the estimated per share fair value of the shares underlying those options on the date of grant. ▪ Risk-Free Interest Rate. The Company bases the risk-free interest rate used in the Black-Scholes valuation model on the implied yield available on U.S. Treasury zero-coupon issues with a term equivalent to that of the term of the options for each option group on the measurement date. ▪ Term. For employee stock options, the expected term represents the period that the Company’s share-based awards are expected to be outstanding. Because of the limitations on the sale or transfer of the Company’s shares during the period the Company was a privately held company, the Company does not believe its historical exercise pattern is indicative of the pattern it will experience as a publicly traded company. The Company consequently uses the Staff Accounting Bulletin 110, or SAB 110, simplified method to calculate the expected term of employee stock options, which is the average of the contractual term and vesting period. The Company plans to continue to use the SAB 110 simplified method until it has sufficient trading history as a publicly traded company. For consultant stock options, the term used is equal to the remaining contractual term on the measurement date. ▪ Volatility. The Company determines the price volatility based on the historical volatilities of industry peers as it does not have sufficient trading history for its shares. Industry peers consist of several public companies in the medical device industry with comparable characteristics, including revenue growth, operating model and working capital requirements. The Company intends to continue to consistently apply this process using the same or a similar peer group of public companies until a sufficient amount of historical information regarding the volatility of its own shares becomes available, or unless circumstances change such that the identified peer companies are no longer similar, in which case other suitable peer companies whose common share prices are publicly available would be utilized in the calculation. The volatility is calculated based on the term on the measurement date. ▪ Dividend Yield. The expected dividend assumption is based on the Company’s current expectations about its anticipated dividend policy. The Company has no expectation that it will declare dividends on its common shares, and therefore has used an expected dividend yield of zero. The fair value of stock options granted to employees was estimated using the following assumptions: Three Months Ended March 31, 2022 2021 Volatility 59% 60% Risk-free interest rate 1.6% 0.7% - 1.1% Term (in years) 6.25 6.25 Dividend yield — — Stock Options Granted to Non-Employees Share-based compensation expense related to stock options granted to non-employees is recognized as the stock options are earned using an accelerated attribution method. The Company believes that the estimated fair value of the stock options is more readily measurable than the fair value of the services rendered. For the three months ended March 31, 2022 and 2021, the Company recognized a benefit of $37,000 and an expense of $0.5 million, respectively, for stock options granted to consultants. The fair value of stock options granted to consultants was estimated using the following assumptions during the following periods presented: Three Months Ended March 31, 2021 Volatility 60% Risk-free interest rate 1.6% Term (in years) 10 Dividend yield — The Company did not grant any stock options to consultants in the three months ended March 31, 2022. Restricted Stock Each vested RSU entitles the holder to be issued one common share. These awards vest according to a vesting schedule determined by the Compensation Committee of the Company’s Board of Directors, generally over a one The following table represents RSU activity for fiscal 2022: Restricted Stock Units Weighted- Outstanding unvested at December 31, 2021 3,982 $ 69.05 Granted 17,043 49.87 Vested — — Forfeited/canceled — — Outstanding unvested at March 31, 2022 21,025 $ 53.50 The fair value of restricted stock is the grant date market value of common shares. The Company recognizes share-based compensation expense related to restricted stock using a straight-line method over the vesting term of the awards. The share-based compensation expense for restricted stock that vested during the three months ended March 31, 2022 and 2021, was $0.6 million and $0.2 million, respectively, which was calculated based on the market value of the Company’s common shares on the applicable grant date. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share The following table summarizes the computation of basic and diluted net loss per share for the periods presented: Three Months Ended March 31, 2022 2021 (in thousands, except share and per share data) Numerator: Net loss $ (5,933) $ (6,948) Denominator: Weighted average common shares used for basic and diluted earnings per share 24,310,856 23,827,137 Net loss per share: Basic and diluted $ (0.24) $ (0.29) Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted- average number of shares and dilutive share equivalents outstanding for the period, determined using the treasury-share method and the as-if converted method, for convertible securities, if inclusion of these is dilutive . If the Company reports a net loss , diluted net loss per share is the same as basic net loss per share for those periods because including the dilutive securities would be anti-dilutive. The following potentially dilutive securities outstanding at the end of the periods presented have been excluded from the computation of diluted shares: Three Months Ended March 31, 2022 2021 Options to purchase common shares 1,768,619 1,900,825 Shares issuable on vesting of grants of restricted stock 21,025 42,685 Warrants to purchase common shares 5,500 5,500 Total 1,795,144 1,949,010 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsDuring the three months ended March 31, 2022 and 2021, the Company recorded revenue of $0.4 million and $0.2 million, respectively, for product sales to Herramientas Medicas, S.A., a distribution company owned by a family member of the Chief Executive Officer of the Company. Accounts receivable owed to the Company from this distribution company amounted to approximately $0.5 million and $0.4 million as of March 31, 2022 and December 31, 2021, respectively. In 2016, the Company also entered into a separate agreement with Dr. Chacón Quirós, the brother of the Company’s Chief Executive Officer Juan José Chacón Quirós, to maintain his clinic in Costa Rica as a MotivaImagine Excellence Center and to host and train physicians in the use of the Company products in relevant procedures, among other services, in exchange for cash reimbursement of up to $4,500 per day that such services are rendered. In December 2020, Dr. Chacón Quirós was granted options to purchase 22,068 common shares vesting over four years in equal annual installments, provided that he continues to provide these services at such times. During the three months ended March 31, 2022 and 2021, the Company paid Dr. Chacón Quirós approximately $32,000 and $93,000, respectively, for services rendered. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Contingencies Periodically, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual or disclosure at March 31, 2022 and 2021. Indemnification The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification agreements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future, but have not yet been made. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Refinancing of Credit Agreement On April 26, 2022, or the Closing Date, the Company entered into the Credit Agreement pursuant to which the Lenders agreed to make term loans to the Company in an aggregate principal amount of up to $225 million, or collectively, the Term Loans. Pursuant to the terms of the Credit Agreement, the Term Loans will be advanced in four tranches: • The first tranche, or the Tranche A Term Loan, was advanced in the amount of $150 million on the Closing Date. • The second tranche, or the Tranche B Term Loan, of $25 million will be advanced at the Company’s election prior to September 30, 2023, subject to satisfaction of specified gross sales thresholds and subject to the other terms and conditions of the Credit Agreement. • The third tranche, or the Tranche C Term Loan, of $25 million will be advanced at the Company’s election prior to March 31, 2024, subject to the Administrative Agent having received either (a) evidence that specified FDA approvals have been issued or (b) evidence that specified gross sales thresholds have been met, and subject to the other terms and conditions of the Credit Agreement. • The fourth tranche, or the Tranche D Term Loan, of $25 million will be advanced at the Company’s election prior to December 31, 2024, subject to the Administrative Agent having received both (a) evidence that specified FDA approvals have been issued and (b) evidence that specified gross sales thresholds have been met (the satisfaction of both (a) and (b), the “Tranche D Funding Milestone”), and subject to the other terms and conditions of the Credit Agreement. The Term Loans will mature on the 5-year anniversary of the Closing Date, or the Maturity Date. The Term Loans accrue interest at a rate equal to 9% per annum or, at any time following the Tranche D Funding Milestone, 8.25% per annum. Accrued interest is due and payable in cash on the last business day of March, June, September, and December of each year, commencing on June 30, 2022; provided, however, that prior to the 2nd anniversary of the Closing Date, the Company may pay an amount of interest on the outstanding Term Loans corresponding to 600 basis points of the interest rate in kind on each applicable payment date, subject to prior written notice delivered to the Administrative Agent. Each of the Term Loans will be subject to original issue discount of 2% of the principal amount thereof upon the drawing of each applicable tranche. Upon any payment or prepayment in full or in part of the Term Loans, whether voluntary or involuntary, the Company is required to pay an exit fee equal to 3% of the principal amount of the Term Loan paid, or the Exit Fee. The Company may elect to prepay all or any portion of the amounts owed prior to the Maturity Date, provided that the Company provides notice to the Administrative Agent, the amount is not less than $5 million, and the amount is accompanied by all accrued and unpaid interest thereon through the date of prepayment, plus the applicable yield protection premium and the applicable Exit Fee. Prepayments of the Term Loans prior to the 2nd anniversary of the Closing Date will be accompanied by a yield protection premium equal to the sum of all interest that would have accrued through such 2nd anniversary plus 4% of the principal amount so prepaid. Prepayments of the Term Loans after the 2nd anniversary will be accompanied by a yield protection premium equal to 4% of the principal amount so prepaid if made prior to the 3rd anniversary of the Closing Date, 2% if made on or after the 3rd anniversary of the Closing Date but prior to the 4th anniversary of the Closing Date, and 0% if made on or after the 4th anniversary of the Closing Date. If the Term Loans are accelerated following the occurrence of an event of default, the Company shall immediately pay to Lenders the sum of all obligations for principal, accrued interest, the applicable yield maintenance premium and the applicable Exit Fee. Pursuant to the Credit Agreement, the obligations of the Company are guaranteed by its subsidiaries that are party thereto as guarantors. On the Closing Date, the Company and such subsidiaries entered into a U.S. Security Agreement in favor of the Administrative Agent on behalf of Lenders, or the U.S. Security Agreement. Pursuant to the U.S. Security Agreement, the Company and its subsidiaries party thereto granted the Administrative Agent a security interest in substantially all of its personal property, rights and assets to secure the payment of all amounts owed to Lenders under the Credit Agreement. The Credit Agreement contains customary affirmative and restrictive covenants and representations and warranties. The Company and its subsidiaries are bound by certain affirmative covenants setting forth actions that are required during the term of the Credit Agreement, including, without limitation, certain information delivery requirements, obligations to maintain certain insurance, and certain notice requirements. Additionally, the Company and its subsidiaries are bound by certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Credit Agreement without prior written consent, including, without limitation, incurring certain additional indebtedness, consummating certain mergers, acquisitions or other business combination transactions, or incurring any non- permitted lien or other encumbrance on the assets of the Company or any of its subsidiaries. The Credit Agreement also contains other customary provisions, such as confidentiality obligations and indemnification rights for the benefit of Lenders. The Credit Agreement contains financial covenants requiring (a) the Company to maintain minimum liquidity of at least $20 million from and after the Closing Date or $25 million from and after the funding of the Tranche B Term Loans, and (b) for each fiscal quarter until gross sales of the Company and its subsidiaries for any 12-consecutive month period are no less than $200 million, minimum gross sales of the Company and its subsidiaries for each consecutive 12-month period ending on the last day of each fiscal quarter in excess of 50% of specified target gross sales for such period. The Credit Agreement provides for a customary equity cure right in the event the Company fails to comply with the minimum gross sales covenant. As of May 10, 2022, $150.0 million was outstanding under the Credit Agreement. A portion of the proceeds from the Term Loans were used to repay in full the $65.0 million in aggregate principal amount outstanding under the Madryn Credit Agreement, and the Madryn Credit Agreement was terminated. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation/Unaudited Interim Condensed Consolidated Financial Information | Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the applicable rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. |
Consolidation | The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the years ended December 31, 2021, 2020 and 2019 presented in the Company’s Form 10-K filed with the SEC on March 1, 2022. The condensed consolidated financial statements include the Company’s accounts and those of its wholly owned subsidiaries as of March 31, 2022 as follows: Subsidiary Incorporation/Acquisition Date Establishment Labs, S.A. (Costa Rica) January 18, 2004 Motiva USA, LLC (USA) February 20, 2014 JAMM Technologies, Inc. (USA) October 27, 2015 Establishment Labs Produtos par Saude Ltda (Brazil) January 4, 2016 European Distribution Center Motiva BVBA (Belgium) March 4, 2016 Motiva Implants France SAS (France) September 12, 2016 JEN-Vault AG (Switzerland) November 22, 2016 Motiva Nordica AB (Sweden) November 2, 2017 Motiva Implants UK Limited (the United Kingdom) July 31, 2018 Motiva Italy S.R.L (Italy) July 31, 2018 Motiva Implants Spain, S.L. (Spain) January 3, 2019 Motiva Austria GmbH (Austria) January 14, 2019 Motiva Germany GmbH (Germany) August 1, 2019 Motiva Argentina S.R.L (Argentina) February 7, 2020 |
Segments | Segments The chief operating decision maker for the Company is the Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The Company and its Chief Executive Officer evaluate performance based primarily on revenue in the geographic regions in which the Company operates. |
Geographic Concentrations | Geographic Concentrations The Company derives all its revenues from sales to customers in Europe, the Middle East, Latin America, and Asia, and has not yet received approval to sell its products in the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Significant accounting estimates and management judgments reflected in the condensed consolidated financial statements include items such as accounts receivable valuation and allowances, inventory valuation and allowances, valuation of acquired intangible assets, valuation of derivatives and valuation of deferred income tax assets, including tax valuation allowances. Estimates are based on historical experience, where applicable, and other assumptions believed to be reasonable by management. Actual results may differ from those estimates under different assumptions or conditions. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist principally of cash and accounts receivable. The majority of the Company’s cash is held at two financial institutions in the United States. Balances in the Company’s cash accounts exceed the Federal Deposit Insurance Corporation, or FDIC, limit of $250,000. The Company has not experienced any losses to its deposits of cash. All of the Company’s revenue has been derived from sales of its products in international markets, principally Europe, the Middle East, Latin America, and Asia. In the international markets in which the Company operates, the Company uses a combination of distributors and makes direct sales to customers. The Company performs ongoing credit evaluations of its distributors and customers, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary. Substantially all of the Company’s revenues were derived from the sale of Motiva Implants. During the three months ended March 31, 2022 and 2021, no customer accounted for more than 10% of the Company’s revenue. No customers accounted for more than 10% of the Company’s trade accounts receivable balance as of March 31, 2022. One customer accounted for 11.8% of the Company’s trade accounts receivable balance as of December 31, 2021 . The Company relies on NuSil Technology, LLC, or NuSil, as the sole supplier of medical-grade silicone used in Motiva Implants. During the three months ended March 31, 2022 and 2021, the Company had purchases of $7.3 million, or 31.4% of total purchases, and $4.3 million, or 55.8% of total purchases, respectively, from NuSil. As of March 31, 2022 and December 31, 2021 , the Company had an outstanding balance owed to this vendor of $2.7 million and $2.5 million, respectively. The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of regulatory approval of the Company’s current and potential future products, uncertainty of market acceptance of the Company’s products, competition from substitute products and larger companies, securing and protecting proprietary technology, access to capital, strategic relationships and dependence on key individuals and sole source suppliers. Products developed by the Company require clearances from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary clearances. If the Company is denied clearance, clearance is delayed, or the Company is unable to maintain its existing clearances, these developments could have a material adverse impact on the Company. The COVID-19 outbreak caused a material disruption of the operations of the Company and its suppliers and customers in fiscal 2020 and, to a lesser degree, in fiscal 2021 and resulted in delayed clinical trial enrollment within the reconstruction cohort of its IDE clinical trial in the United States. However, to date, the impact from the COVID-19 outbreak has not had a material effect on the Company’s liquidity or financial position. The full extent of |
Cash | Cash The Company’s cash consists of cash maintained in checking and interest-bearing accounts. The majority of the Company’s cash is held at two financial institutions in the United States. The Company accounts for financial instruments with original maturities of three months or less at the date of purchase as cash equivalents. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful AccountsAccounts receivable is stated at invoice value less estimated allowances for returns and doubtful accounts. The Company continually monitors customer payments and maintains an allowance for estimated losses resulting from customers’ inability to make required payments. In evaluating the Company’s ability to collect outstanding receivable balances, the Company considers various factors including the age of the balance, the creditworthiness of the customer, which is assessed based on ongoing credit evaluations and payment history, and the customer’s current financial condition. In cases where there are circumstances that may impair a specific customer’s ability to meet its financial obligations, an allowance is recorded against amounts due, which reduces the net recognized receivable to the amount reasonably believed to be collectible. |
Inventory and Cost of Revenue | Inventory and Cost of Revenue Inventory is stated at the lower of cost to purchase or manufacture the inventory or the net realizable value of such inventory. Cost is determined using the standard cost method which approximates actual costs using the first-in, first-out basis. The Company regularly reviews inventory quantities considering actual losses, projected future demand, and remaining shelf life to record a provision for excess and slow-moving inventory. An inventory reserve of $2.6 million and $1.2 million has been recorded as of March 31, 2022 and December 31, 2021, respectively. |
Leases | Leases The Company determines if an arrangement is, or contains, a lease at the inception date of the contract. The Company has elected an expedient to account for each separate lease component and its associated non-lease components as a single lease component for the majority of its asset classes. The lease term may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise a renewal option, or reasonably certain it will not exercise an early termination option. The Company recognizes lease liabilities and right-of-use, or ROU, assets upon commencement for all material leases with a term greater than 12 months. The Company has elected an expedient not to recognize leases with a lease term of 12 months or less on the balance sheet. These short-term leases are expensed on a straight-line basis over the lease term. |
Shipping and Handling Costs/Revenue Recognition | Shipping and Handling CostsShipping and handling costs are expensed as incurred and are included in selling, general and administrative, or SG&A, expenses. Revenue Recognition The Company recognizes revenue related to sales of products to distributors or directly to customers in markets where it has regulatory approval, net of discounts and allowances. The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC, Revenue from Contracts with Customers (Topic 606). ASC 606 requires the Company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. The Company recognizes revenue related to the sales of products to distributors at the time of shipment of the product, which represents the point in time when the distributor has taken ownership and assumed the risk of loss, and the required revenue recognition criteria are satisfied. The Company’s distributors are obligated to pay within specified terms regardless of when, or if, they sell the products. The Company’s contracts with distributors typically do not contain right of return or price protection and have no post-delivery obligations. The Company recognizes revenue when title to the product and risk of loss transfer to customers, provided there are no remaining performance obligations required of the Company or any written matters requiring customer acceptance. The Company allows for the return of product from direct customers in certain regions in limited instances within fifteen days after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized. Appropriate reserves are established for anticipated sales returns based on historical experience, recent gross sales and any notification of pending returns. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period is recorded. As of March 31, 2022 and December 31, 2021 , an allowance of $3,000 and $10,000 was recorded for product returns, respectively. A portion of the Company’s revenue is generated from the sale of consigned inventory maintained at physician, hospital, or clinic locations. For these products, revenue is recognized at the time the Company is notified by the consignee that the product has been implanted, not when the consigned products are delivered to the consignee’s warehouse. Revenue was generated in these primary geographic markets: Three Months Ended March 31, 2022 2021 (in thousands) Europe $ 14,339 $ 12,693 Latin America 12,186 8,001 Asia-Pacific/Middle East 11,620 9,495 Other 307 147 $ 38,452 $ 30,336 The Company has a limited warranty for the shelf life of breast implants, which is five years from the time of manufacture. Estimated warranty obligations are recorded at the time of sale. The Company also offers a warranty to patients in the event of rupture and a replacement program for capsular contracture events, provided certain registration requirements are met. Revenue for extended warranties is recognized ratably over the term of the agreement. To date, these warranty and program costs have been de minimis. The Company will continue to evaluate the warranty reserve policies for adequacy considering claims history. Deferred revenue primarily consists of payments received in advance of meeting revenue recognition criteria. The Company has received payments from distributors to provide distribution exclusivity within a geographic area and recognizes deferred revenue on a ratable basis over the term of such contractual distribution relationship. Additionally, the Company has received payments from customers in direct markets prior to surgical implantation and recognizes deferred revenue at the time the Company is notified by the customer that the product has been implanted. For all arrangements, any revenue that has been deferred and is expected to be recognized beyond one year is classified as long-term deferred revenue and included in “Other liabilities, long-term” on the condensed consolidated balance sheets (see Note 3). |
Research and Development | Research and Development Costs related to research and development, or R&D, activities are expensed as incurred. R&D costs primarily include personnel costs, materials, clinical expenses, regulatory expenses, product development, consulting services, and outside research activities, all of which are directly related to research and development activities. |
Selling, General and Administrative Expenses | Selling, General and Administrative ExpensesSG&A expenses include sales and marketing costs, payroll and related benefit costs, insurance expenses, shipping and handling costs, legal and professional fees and administrative overhead. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. five |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company records the excess of the acquisition purchase price over the net fair value of the tangible and identifiable intangible assets acquired and liabilities assumed as goodwill. In accordance with ASC 350, Intangibles - Goodwill and Other, the Company tests goodwill for impairment annually during the fourth quarter of each year and whenever events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. In connection with the annual impairment test for goodwill, the Company elected the option to perform a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If the Company determines that it was more likely than not that the fair value of the reporting unit is less than its carrying amount, then the impairment test is performed. Consistent with the Company's assessment that it has only one reporting segment, the Company has determined that it has only one reporting unit and tests goodwill for impairment at the entity level using the two-step process required by ASC 350. In the first step, the Company compares the carrying amount of the reporting unit to the fair value of the enterprise. If the fair value of the enterprise exceeds the carrying value, goodwill is not considered impaired and no further testing is required. If the carrying value of the enterprise exceeds the fair value, goodwill is potentially impaired, and the second step of the impairment test must be performed. In the second step, the Company compares the implied fair value of the goodwill, as defined by ASC 350, to its carrying amount to determine the impairment loss, if any. The Company capitalizes certain costs related to intangible assets, such as patents, trademarks and software development costs. The Company follows the provisions of ASC 350-40, Internal Use Software for determining whether computer software is internal-use software and on accounting for the proceeds of computer software originally developed or obtained for internal use. The Company expenses all costs incurred during the preliminary project stage of software development and capitalizes the costs incurred during the application development stage. Costs incurred relating to upgrades and enhancements to the software are capitalized if it is determined that these upgrades or enhancements add additional functionality to the software. Costs incurred to improve and support products after they become available are charged to expense as incurred. The Company records purchased intangible assets at their respective estimated fair values at the date of two |
Long-Lived Assets | Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. When such an event occurs, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the related asset group’s carrying value. If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. There were no impairment charges, or changes in estimated useful lives recorded d uring the year ended December 31, 2021. As of March 31, 2022, no triggering events have occurred which would indicate that the acquired long-lived asset values may not be recoverable. |
Debt and Embedded Derivatives | Debt and Embedded Derivatives The Company applies the accounting standards for derivatives and for distinguishing liabilities from equity when accounting for hybrid contracts. The Company accounts for convertible debt instruments when the Company has determined that the embedded conversion options should not be bifurcated from their host instruments in accordance with ASC 470-20 Debt with Conversion and Other Options (see Note 6). The Company uses option pricing valuation models to determine the fair value of embedded derivatives and records any change in fair value as a component of other income or expense in the condensed consolidated statements of operations (see Note 5). |
Debt Issuance Costs and Debt Discounts | Debt Issuance Costs and Debt Discounts Costs incurred in connection with the issuance of new debt are capitalized. Capitalizable debt issuance costs paid to third parties and debt discounts, net of amortization, are recorded as a reduction to the long-term debt balance on the condensed consolidated balance sheets. Amortization expense on capitalized debt issuance costs and debt discounts related to loans are calculated using the effective interest method over the term of the loan commitment and is recorded as interest expense in the condensed consolidated statements of operations. |
Income Taxes | Income Taxes The Company records income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s consolidated financial statements or income tax returns. In estimating future tax consequences, expected future events, enactments or changes in the tax law or rates are considered. Valuation allowances are provided when necessary to reduce deferred tax assets to the amount expected to be realized. The Company operates in various tax jurisdictions and is subject to audit by various tax authorities. The Company records uncertain tax positions based on a two-step process whereby (1) a determination is made as to whether it is more likely than not that the tax positions will be sustained based on the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold the Company recognizes the largest amount of tax benefit that is greater than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Significant judgment is required in the |
Foreign Currency | Foreign Currency The financial statements of the Company’s foreign subsidiaries whose functional currencies are the local currencies are translated into U.S. dollars for consolidation as follows: assets and liabilities at the exchange rate as of the balance sheet date, stockholders’ equity at the historical rates of exchange, and income and expense amounts at the average exchange rate for the period. Translation adjustments resulting from the translation of the subsidiaries’ accounts are included in “Accumulated other comprehensive income” as equity in the condensed consolidated balance sheet. Transactions denominated in currencies other than the applicable functional currency are converted to the functional currency at the exchange rate on the transaction date. At period end, monetary assets and liabilities are remeasured to the functional currency using exchange rates in effect at the balance sheet date. Non-monetary assets and liabilities are remeasured at historical exchange rates. Gains and losses resulting from foreign currency transactions are included within “Other income (expense), net” in the condensed consolidated statements of operations. |
Comprehensive Income (Loss) | Comprehensive LossThe Company’s comprehensive loss consists of net loss and foreign currency translation adjustments arising from the consolidation of the Company’s foreign subsidiaries. |
Share-based Compensation | Share-Based Compensation The Company measures and recognizes compensation expense for all share-based awards in accordance with the provisions of ASC 718, Stock Compensation . Share-based awards granted include stock options, restricted stock units, or RSUs, and restricted stock awards, or RSAs. Share-based compensation expense for stock options and restricted stock granted to employees is measured at the grant date based on the fair value of the awards and is recognized as an expense ratably on a straight-line basis over the requisite service period. The fair value of options to purchase shares granted to employees is estimated on the grant date using the Black-Scholes option valuation model. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share is calculated by dividing the net income (loss) attributable to shareholders by the weighted-average number of shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted-average number of shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, any shares issuable upon exercise of warrants, stock options and non-vested restricted stock outstanding under the Company’s equity plan are potentially dilutive securities. Diluted net loss per share is the same as basic net loss per share for periods where the Company reported a net loss because including the dilutive securities would be anti-dilutive. |
Recent Accounting Standards | Recent Accounting Standards Periodically, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Previously, under the Jumpstart Our Business Startups Act of 2012, or JOBS Act, the Company met the definition of an emerging growth company, and previously elected the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. The Company ceased to be an emerging growth company on December 31, 2021. The following recent accounting pronouncements issued by the FASB could have a material effect on the Company’s financial statements: Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) . The new guidance eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, the new guidance modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. This standard is currently effective. The Company adopted ASU 2019-12 as of January 1, 2022. The adoption did not have a material impact upon the Company’s financial position and results of operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Consolidated Entities | The condensed consolidated financial statements include the Company’s accounts and those of its wholly owned subsidiaries as of March 31, 2022 as follows: Subsidiary Incorporation/Acquisition Date Establishment Labs, S.A. (Costa Rica) January 18, 2004 Motiva USA, LLC (USA) February 20, 2014 JAMM Technologies, Inc. (USA) October 27, 2015 Establishment Labs Produtos par Saude Ltda (Brazil) January 4, 2016 European Distribution Center Motiva BVBA (Belgium) March 4, 2016 Motiva Implants France SAS (France) September 12, 2016 JEN-Vault AG (Switzerland) November 22, 2016 Motiva Nordica AB (Sweden) November 2, 2017 Motiva Implants UK Limited (the United Kingdom) July 31, 2018 Motiva Italy S.R.L (Italy) July 31, 2018 Motiva Implants Spain, S.L. (Spain) January 3, 2019 Motiva Austria GmbH (Austria) January 14, 2019 Motiva Germany GmbH (Germany) August 1, 2019 Motiva Argentina S.R.L (Argentina) February 7, 2020 |
Disaggregation of Revenue | Revenue was generated in these primary geographic markets: Three Months Ended March 31, 2022 2021 (in thousands) Europe $ 14,339 $ 12,693 Latin America 12,186 8,001 Asia-Pacific/Middle East 11,620 9,495 Other 307 147 $ 38,452 $ 30,336 |
Balance Sheet Accounts (Tables)
Balance Sheet Accounts (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of inventory, current | March 31, December 31, (in thousands) Raw materials $ 7,609 $ 8,519 Work in process 1,861 1,396 Finished goods 19,068 18,492 $ 28,538 $ 28,407 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets March 31, December 31, (in thousands) Prepaid insurance $ 2,082 $ 2,315 Prepaid raw materials and accessories 386 577 Prepaid warranty and distribution rights 174 516 Prepaid U.S. clinical trial costs 761 412 Prepaid taxes 735 551 Other 2,995 2,641 $ 7,133 $ 7,012 |
Property, Plant and Equipment | March 31, December 31, (in thousands) Machinery and equipment $ 10,442 $ 10,240 Construction in process 7,725 3,174 Building improvements 6,804 6,713 Furniture and fixtures 5,126 4,761 Building 2,472 2,472 Leasehold improvements 2,192 2,118 Land 802 802 Vehicles 272 268 Total 35,835 30,548 Less: Accumulated depreciation and amortization (12,534) (11,890) $ 23,301 $ 18,658 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: March 31, December 31, (in thousands) Performance bonus $ 4,495 $ 3,346 Payroll and related expenses 4,342 3,904 Bonus feature of stock option grants 5,968 5,570 Operating lease liabilities - current 405 402 Commissions 951 1,138 Professional and legal services 914 819 Warranty reserve 170 167 Cash payable for asset acquisitions - contingent consideration — 137 Other 812 753 $ 18,057 $ 16,236 |
Other Current Liabilities | Other liabilities, short-term consisted of the following: March 31, December 31, (in thousands) Deferred revenue $ 1,266 $ 769 Cash payable for asset acquisitions 536 409 $ 1,802 $ 1,178 |
Other Noncurrent Liabilities | Other liabilities, long-term consisted of the following: March 31, December 31, (in thousands) Deferred revenue $ 1,821 $ 2,392 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | There were no changes in the carrying amount of goodwill during the three months ended March 31, 2022: Balance as of January 1, 2022 Additions Accumulated Impairment Losses Balance as of March 31, 2022 (in thousands) Goodwill $ 465 $ — $ — $ 465 |
Schedule of Finite-Lived Intangible Assets | The carrying amounts of these intangible assets other than goodwill as of March 31, 2022 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,757 $ (1,179) $ 578 7-12 Customer relationships 2,033 (1,849) 184 4-10 510(k) authorization 567 (241) 326 15 Developed technology 62 (53) 9 10 Capitalized software development costs 4,010 (971) 3,039 2-5 Other 75 (32) 43 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,795 $ (4,325) $ 4,470 The carrying amounts of intangible assets other than goodwill as of December 31, 2021 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,736 $ (1,136) $ 600 7-12 Customer relationships 2,033 (1,799) 234 4-10 510(k) authorization 567 (232) 335 15 Developed technology 62 (52) 10 10 Capitalized software development costs 3,648 (791) 2,857 2-5 Other 75 (31) 44 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,412 $ (4,041) $ 4,371 |
Schedule of Indefinite-Lived Intangible Assets | The carrying amounts of these intangible assets other than goodwill as of March 31, 2022 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,757 $ (1,179) $ 578 7-12 Customer relationships 2,033 (1,849) 184 4-10 510(k) authorization 567 (241) 326 15 Developed technology 62 (53) 9 10 Capitalized software development costs 4,010 (971) 3,039 2-5 Other 75 (32) 43 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,795 $ (4,325) $ 4,470 The carrying amounts of intangible assets other than goodwill as of December 31, 2021 were as follows: Gross Carrying Amount Accumulated Amortization Net Carrying Amount Estimated Useful Lives (in thousands) (in years) Patents and license rights $ 1,736 $ (1,136) $ 600 7-12 Customer relationships 2,033 (1,799) 234 4-10 510(k) authorization 567 (232) 335 15 Developed technology 62 (52) 10 10 Capitalized software development costs 3,648 (791) 2,857 2-5 Other 75 (31) 44 2-5 Capitalized patents and license rights not yet amortized 291 — 291 $ 8,412 $ (4,041) $ 4,371 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | As of March 31, 2022, the amortization expense related to identifiable intangible assets, with definite useful lives, in future periods is expected to be as follows: Year Ending December 31, (in thousands) 2022 (remaining) $ 902 2023 931 2024 857 2025 689 2026 403 Thereafter 397 Total $ 4,179 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Liabilities Measured on Recurring Basis | The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy at period end: Fair Value Measurements at March 31, 2022 Total Level 1 Level 2 Level 3 (in thousands) Liabilities Madryn put option liability $ 1,099 $ — $ — $ 1,099 Fair Value Measurements at December 31, 2021 Total Level 1 Level 2 Level 3 (in thousands) Liabilities Madryn put option liability $ 703 $ — $ — $ 703 |
Fair Value Measurement Inputs and Valuation Techniques | The Company used the following assumptions to value Madryn derivatives: Madryn Put Option Liability March 31, 2022 December 31, 2021 Interest rate volatility 29.2% 25.8% Market yield rate 7.3% 6.8% Term (in years) 3.50 3.75 Dividend yield — — |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments as follows: Madryn Put Option Liability Balance at December 31, 2021 $ 703 Change in fair value 396 Balance at March 31, 2022 $ 1,099 Balance at December 31, 2020 $ 1,440 Change in fair value (230) Balance at March 31, 2021 $ 1,210 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt | The Company recorded Madryn debt on the balance sheet as follows: March 31, December 31, (in thousands) Principal $ 65,000 $ 65,000 Net unamortized debt discount and issuance costs (12,514) (13,094) Net carrying value of Madryn debt $ 52,486 $ 51,906 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Lease, Cost | Total lease cost includes the following components for the three months ended March 31, 2022 and 2021, as well as for the year ended December 31, 2021: March 31, March 31, (in thousands) Operating lease expense cost $ 147 $ 167 Finance lease costs Interest expense 1 3 Amortization expense 25 35 Total finance lease costs $ 26 $ 38 March 31, March 31, Cash paid for amounts included in the measurement of lease liabilities (in thousands) Operating cash outflows from operating leases $ 147 $ 160 Operating cash outflows from finance leases $ 1 $ 3 Financing cash outflows from finance leases $ 7 $ 55 ROU assets obtained in exchange for new lease liabilities Operating leases $ — $ — Finance leases $ 36 $ — |
Assets And Liabilities, Lessee | March 31, December 31, 2021 Supplemental balance sheet information (in thousands) Operating leases Operating lease right-of-use assets $ 2,113 $ 2,206 Operating lease liabilities - short-term 405 402 Operating lease liabilities - long-term 1,805 1,900 Total operating lease liabilities $ 2,210 $ 2,302 Finance leases Finance lease right-of-use assets $ 187 $ 154 Finance lease liabilities - short-term 12 13 Finance lease liabilities - long-term 30 — Total finance lease liabilities $ 42 $ 13 Weighted-average remaining lease term (years) Operating leases 5.2 5.5 Finance leases 4.0 0.8 Weighted-average discount rate (%) Operating leases 10.4 % 10.4 % Finance leases 8.2 % 8.3 % |
Lessee, Operating Lease, Liability, Maturity | Maturities of lease liabilities as of March 31, 2022 were as follows: Years Ending December 31, Operating Leases Finance Leases (in thousands) 2022 $ 416 $ 14 2023 535 9 2024 504 9 2025 429 9 2026 404 9 Thereafter 436 — Total future minimum lease payments 2,724 50 Less: Amount of lease payments representing interest (514) (8) Present value of future minimum lease payments $ 2,210 $ 42 |
Finance Lease, Liability, Fiscal Year Maturity | Maturities of lease liabilities as of March 31, 2022 were as follows: Years Ending December 31, Operating Leases Finance Leases (in thousands) 2022 $ 416 $ 14 2023 535 9 2024 504 9 2025 429 9 2026 404 9 Thereafter 436 — Total future minimum lease payments 2,724 50 Less: Amount of lease payments representing interest (514) (8) Present value of future minimum lease payments $ 2,210 $ 42 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Reserved Ordinary Shares for Future Issuances | The Company had reserved common shares for future issuances as follows: March 31, December 31, Warrants to purchase common shares 5,500 5,500 Options to purchase common shares 1,956,119 2,098,087 Remaining shares available under the 2018 Equity Incentive Plan 2,558,834 1,780,687 Shares issuable on vesting of grants of RSUs 21,025 3,982 Remaining shares available under the 2018 ESPP 848,000 661,000 Total 5,389,478 4,549,256 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | As of each of March 31, 2022 and December 31, 2021, 5,500 warrants to purchase the Company’s common shares were outstanding and exercisable: Warrant Holder Issue Date In Connection With Warrant to Purchase Shares Exercise Price Expiration Date Rockport 3/3/2017 Loan agreement Common 5,500 $ 3.80 8/28/2022 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Expense | During the periods presented, the Company recorded the following share-based compensation expense for stock options and restricted stock awards: Three Months Ended March 31, 2022 2021 (in thousands) Sales, general and administrative $ 2,967 $ 1,146 Research and development 467 611 Total $ 3,434 $ 1,757 |
Schedule of Stock Options | Stock Options Number of Options Outstanding Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Balances at December 31, 2021 2,098,087 $ 37.49 7.67 $ 67,357 Granted (weighted-average fair value $45.54 per share) 11,045 33.44 Exercised (113,821) 14.96 Forfeited/canceled (39,192) 33.02 Balances at March 31, 2022 1,956,119 $ 38.87 7.55 $ 60,107 |
Schedule of Employee Stock Options Valuation Assumptions | The fair value of stock options granted to employees was estimated using the following assumptions: Three Months Ended March 31, 2022 2021 Volatility 59% 60% Risk-free interest rate 1.6% 0.7% - 1.1% Term (in years) 6.25 6.25 Dividend yield — — The fair value of stock options granted to consultants was estimated using the following assumptions during the following periods presented: Three Months Ended March 31, 2021 Volatility 60% Risk-free interest rate 1.6% Term (in years) 10 Dividend yield — |
Schedule of Restricted Stock | The following table represents RSU activity for fiscal 2022: Restricted Stock Units Weighted- Outstanding unvested at December 31, 2021 3,982 $ 69.05 Granted 17,043 49.87 Vested — — Forfeited/canceled — — Outstanding unvested at March 31, 2022 21,025 $ 53.50 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings Per Share | The following table summarizes the computation of basic and diluted net loss per share for the periods presented: Three Months Ended March 31, 2022 2021 (in thousands, except share and per share data) Numerator: Net loss $ (5,933) $ (6,948) Denominator: Weighted average common shares used for basic and diluted earnings per share 24,310,856 23,827,137 Net loss per share: Basic and diluted $ (0.24) $ (0.29) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities outstanding at the end of the periods presented have been excluded from the computation of diluted shares: Three Months Ended March 31, 2022 2021 Options to purchase common shares 1,768,619 1,900,825 Shares issuable on vesting of grants of restricted stock 21,025 42,685 Warrants to purchase common shares 5,500 5,500 Total 1,795,144 1,949,010 |
Formation and Business of the_2
Formation and Business of the Company (Details) | Mar. 31, 2022facility |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of manufacturing facilities | 2 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022USD ($)financial_institutionreportingunitsegment | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | segment | 1 | ||
Number of financial institutions | financial_institution | 2 | ||
Cash equivalents | $ 0 | $ 0 | |
Inventory valuation reserves | 2,600,000 | 1,200,000 | |
Sales, general and administrative | $ 26,913,000 | $ 18,138,000 | |
Product return period | 15 days | ||
Valuation allowances and reserves, amount | $ 3,000 | 10,000 | |
Product shelf life | 5 years | ||
Estimated useful lives | 50 years | ||
Number of reportable segments | segment | 1 | ||
Number of reporting units | reportingunit | 1 | ||
Goodwill and intangible asset impairment | 0 | ||
Asset impairment charges | $ 0 | 0 | |
Foreign currency transaction gain (loss) | $ 2,800,000 | (2,700,000) | |
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | 5 years | ||
Estimated useful lives | 2 years | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful lives | 10 years | ||
Estimated useful lives | 15 years | ||
Shipping and Handling | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Sales, general and administrative | $ 1,400,000 | 1,200,000 | |
Product Concentration Risk | NuSil Technology LLC | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Purchases from suppliers | 7,300,000 | $ 4,300,000 | |
Outstanding balance owed | $ 2,700,000 | $ 2,500,000 | |
Revenue | Geographic Concentration Risk | Brazil | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk (as a percent) | 17.40% | 10.60% | |
Purchases | Product Concentration Risk | NuSil Technology LLC | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk (as a percent) | 31.40% | 55.80% | |
Long-lived Assets | Geographic Concentration Risk | COSTA RICA | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk (as a percent) | 88.00% | 84.00% | |
Customer One | Revenue from Contract with Customer Benchmark | Customer concentration risk | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk (as a percent) | 11.80% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 38,452 | $ 30,336 |
Europe | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 14,339 | 12,693 |
Latin America | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 12,186 | 8,001 |
Asia-Pacific/Middle East | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 11,620 | 9,495 |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 307 | $ 147 |
Balance Sheet Accounts - Invent
Balance Sheet Accounts - Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 7,609 | $ 8,519 |
Work in process | 1,861 | 1,396 |
Finished goods | 19,068 | 18,492 |
Inventory, net | $ 28,538 | $ 28,407 |
Balance Sheet Accounts - Prepai
Balance Sheet Accounts - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Prepaid insurance | $ 2,082 | $ 2,315 | |
Prepaid raw materials and accessories | 386 | 577 | |
Prepaid warranty and distribution rights | 174 | 516 | |
Prepaid U.S. clinical trial costs | 761 | 412 | |
Prepaid taxes | 735 | 551 | |
Other | 2,995 | $ 2,641 | |
Prepaid expenses and other current assets | $ 7,133 | $ 7,012 | |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Prepaid expenses and other current assets | Prepaid expenses and other current assets |
Balance Sheet Accounts - Proper
Balance Sheet Accounts - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 35,835 | $ 30,548 |
Less: Accumulated depreciation and amortization | (12,534) | (11,890) |
Property, plant and equipment, net | 23,301 | 18,658 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 10,442 | 10,240 |
Building improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 6,804 | 6,713 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 5,126 | 4,761 |
Building | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,472 | 2,472 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 2,192 | 2,118 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 802 | 802 |
Vehicles | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 272 | $ 268 |
Balance Sheet Accounts - Narrat
Balance Sheet Accounts - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Aug. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||||
Inventory on consignment | $ 4,200 | $ 3,500 | ||
Depreciation and amortization expense | 600 | $ 600 | ||
Finance Lease, ROU asset, before accumulated amortization | 1,400 | $ 1,400 | ||
Depreciation | $ 25 | $ 43 | ||
Land, Buildings and Improvements | Zona Franca Coyol, S.A. | ||||
Property, Plant and Equipment [Line Items] | ||||
Option to purchase land and buildings | $ 12,600 | |||
Land | Zona Franca Coyol, S.A. | ||||
Property, Plant and Equipment [Line Items] | ||||
Option to purchase land and buildings | $ 2,800 |
Balance Sheet Accounts - Accrue
Balance Sheet Accounts - Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Performance bonus | $ 4,495 | $ 3,346 |
Payroll and related expenses | 4,342 | 3,904 |
Bonus feature of stock option grants | 5,968 | 5,570 |
Operating lease liabilities - current | 405 | 402 |
Commissions | 951 | 1,138 |
Professional and legal services | 914 | 819 |
Warranty reserve | 170 | 167 |
Cash payable for asset acquisitions - contingent consideration | 0 | 137 |
Other | 812 | 753 |
Accrued liabilities | $ 18,057 | $ 16,236 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued liabilities | Accrued liabilities |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued liabilities | Accrued liabilities |
Balance Sheet Accounts - Other
Balance Sheet Accounts - Other Liabilities, Short-Term (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deferred revenue | $ 1,266 | $ 769 |
Cash payable for asset acquisitions | 536 | 409 |
Other liabilities, short term | $ 1,802 | $ 1,178 |
Balance Sheet Accounts - Othe_2
Balance Sheet Accounts - Other Liabilities, Long-Term (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deferred revenue | $ 1,821 | $ 2,392 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Assets - Goodwill (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Goodwill [Roll Forward] | |
Beginning Balance | $ 465 |
Additions | 0 |
Accumulated Impairment Losses | 0 |
Ending Balance | $ 465 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Assets - Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Accumulated Amortization | $ (4,325) | $ (4,041) |
Net Carrying Amount | 4,179 | |
Indefinite-lived Intangible Assets (Excluding Goodwill) [Abstract] | ||
Capitalized patents and license rights not yet amortized | 291 | 291 |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | ||
Gross Carrying Amount | 8,795 | 8,412 |
Net Carrying Amount | $ 4,470 | 4,371 |
Minimum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 2 years | |
Maximum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 15 years | |
Patents and license rights | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 1,757 | 1,736 |
Accumulated Amortization | (1,179) | (1,136) |
Net Carrying Amount | $ 578 | $ 600 |
Patents and license rights | Minimum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 7 years | 7 years |
Patents and license rights | Maximum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 12 years | 12 years |
Customer relationships | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 2,033 | $ 2,033 |
Accumulated Amortization | (1,849) | (1,799) |
Net Carrying Amount | $ 184 | $ 234 |
Customer relationships | Minimum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 4 years | 4 years |
Customer relationships | Maximum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 10 years | 10 years |
510(k) authorization | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 567 | $ 567 |
Accumulated Amortization | (241) | (232) |
Net Carrying Amount | $ 326 | $ 335 |
Estimated Useful Lives | 15 years | 15 years |
Developed technology | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 62 | $ 62 |
Accumulated Amortization | (53) | (52) |
Net Carrying Amount | $ 9 | $ 10 |
Estimated Useful Lives | 10 years | 10 years |
Capitalized software development costs | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 4,010 | $ 3,648 |
Accumulated Amortization | (971) | (791) |
Net Carrying Amount | $ 3,039 | $ 2,857 |
Capitalized software development costs | Minimum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 2 years | 2 years |
Capitalized software development costs | Maximum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 5 years | 5 years |
Other | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Gross Carrying Amount | $ 75 | $ 75 |
Accumulated Amortization | (32) | (31) |
Net Carrying Amount | $ 43 | $ 44 |
Other | Minimum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 2 years | 2 years |
Other | Maximum | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Estimated Useful Lives | 5 years | 5 years |
Goodwill and Other Intangible_5
Goodwill and Other Intangible Assets - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization of intangible assets | $ 300,000 | $ 300,000 | |
Goodwill and intangible asset impairment | $ 0 |
Goodwill and Other Intangible_6
Goodwill and Other Intangible Assets - Amortization Expense (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2022 (remaining) | $ 902 |
2023 | 931 |
2024 | 857 |
2025 | 689 |
2026 | 403 |
Thereafter | 397 |
Net Carrying Amount | $ 4,179 |
Fair Value Measurements - FV on
Fair Value Measurements - FV on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Madryn put option liability | $ 1,099 | $ 703 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Madryn put option liability | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Madryn put option liability | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Madryn put option liability | $ 1,099 | $ 703 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) $ in Millions | 12 Months Ended | ||||||
Dec. 31, 2019USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Aug. 31, 2017USD ($) | |
Measurement Input, Probability of Change in Control | |||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||
Change in control | 0.50 | 0.50 | |||||
Line of Credit | Madryn Credit Agreement | |||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||
Fair value of options | $ 15.1 | ||||||
Debt discount | $ 1.6 | $ 5 | $ 5 | ||||
Additional amount borrowed | $ 25 | $ 10 |
Fair Value Measurements - Deriv
Fair Value Measurements - Derivatives (Details) - Madryn Put Option Liability | Mar. 31, 2022 | Dec. 31, 2021 |
Interest rate volatility | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 0.292 | 0.258 |
Market yield rate | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 0.073 | 0.068 |
Term (in years) | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 3.50 | 3.75 |
Dividend yield | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 0 | 0 |
Fair Value Measurements - Level
Fair Value Measurements - Level 3 Financial Instruments (Details) - Madryn Put Option Liability $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning Balance | $ 1,440 |
Change in fair value | (230) |
Ending Balance | $ 1,210 |
Debt - Narrative (Details)
Debt - Narrative (Details) - Line of Credit - USD ($) | Apr. 26, 2022 | Jun. 17, 2019 | Aug. 31, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2018 | May 10, 2022 | Aug. 31, 2017 | Aug. 24, 2017 |
Amended Madryn Credit Agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | $ 65,000,000 | ||||||||
Madryn Credit Agreement | |||||||||
Debt Instrument [Line Items] | |||||||||
Default interest rate | 4.00% | ||||||||
Effective interest rate | 18.40% | ||||||||
Weighted average interest rate | 10.60% | ||||||||
Interest expense | $ 1,700,000 | $ 1,700,000 | |||||||
Fair value of options | $ 15,100,000 | ||||||||
Debt discount | $ 1,600,000 | $ 5,000,000 | $ 5,000,000 | ||||||
Borrowings on credit facility | $ 25,000,000 | $ 10,000,000 | |||||||
Madryn Credit Agreement | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Early repayment amount | $ 6,500,000 | ||||||||
Madryn Credit Agreement | London Interbank Offered Rate (LIBOR) | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit agreement interest rate | 8.00% | ||||||||
Credit Agreement | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | $ 225,000,000 | $ 150,000,000 | |||||||
Effective interest rate | 9.00% | ||||||||
Credit Agreement, Tranche A Term Loan | Subsequent Event | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | $ 150,000,000 | ||||||||
Borrowings under Madryn credit agreement, net of issuance costs | $ 150,000,000 |
Debt - Schedule of Madryn Debt
Debt - Schedule of Madryn Debt (Details) - Madryn Credit Agreement - Line of Credit - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Line of Credit Facility [Line Items] | ||
Principal | $ 65,000 | $ 65,000 |
Net unamortized debt discount and issuance costs | (12,514) | (13,094) |
Net carrying value of Madryn debt | $ 52,486 | $ 51,906 |
Leases - Narrative (Details)
Leases - Narrative (Details) - Maximum | Mar. 31, 2022 |
Lessee, Lease, Description [Line Items] | |
Operating lease, term of contract | 7 years |
Finance lease, term of contract | 7 years |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Leases [Abstract] | ||
Operating lease expense cost | $ 147 | $ 167 |
Interest expense | 1 | 3 |
Amortization expense | 25 | 35 |
Total finance lease costs | $ 26 | $ 38 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Operating leases | ||
Right-of-use operating lease assets, net | $ 2,113 | $ 2,206 |
Operating lease liabilities - current | 405 | 402 |
Operating lease liabilities, non-current | 1,805 | 1,900 |
Operating lease liabilities | 2,210 | 2,302 |
Finance leases | ||
Finance lease right-of-use assets | 187 | 154 |
Finance lease liabilities - short-term | 12 | 13 |
Finance lease liabilities - long-term | 30 | 0 |
Total finance lease liabilities | $ 42 | $ 13 |
Weighted-average remaining lease term (years) | ||
Operating leases | 5 years 2 months 12 days | 5 years 6 months |
Finance leases | 4 years | 9 months 18 days |
Weighted-average discount rate (%) | ||
Operating leases | 10.40% | 10.40% |
Finance leases | 8.20% | 8.30% |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flows (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash paid for amounts included in the measurement of lease liabilities | ||
Operating cash outflows from operating leases | $ 147 | $ 160 |
Operating cash outflows from finance leases | 1 | 3 |
Financing cash outflows from finance leases | 7 | 55 |
ROU assets obtained in exchange for new lease liabilities | ||
Operating leases | 0 | 0 |
Finance leases | $ 36 | $ 0 |
Leases - Lease Maturity (Detail
Leases - Lease Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2022 | $ 416 | |
2023 | 535 | |
2024 | 504 | |
2025 | 429 | |
2026 | 404 | |
Thereafter | 436 | |
Total future minimum lease payments | 2,724 | |
Less: Amount of lease payments representing interest | (514) | |
Present value of future minimum lease payments | 2,210 | $ 2,302 |
Finance Leases | ||
2022 | 14 | |
2023 | 9 | |
2024 | 9 | |
2025 | 9 | |
2026 | 9 | |
Thereafter | 0 | |
Total future minimum lease payments | 50 | |
Less: Amount of lease payments representing interest | (8) | |
Present value of future minimum lease payments | $ 42 | $ 13 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) - shares | Mar. 31, 2022 | Dec. 31, 2021 |
Equity [Abstract] | ||
Common stock, shares issued (in shares) | 24,602,156 | 24,488,335 |
Common stock, shares outstanding (in shares) | 24,194,086 | 24,080,265 |
Shareholders' Equity - Reserved
Shareholders' Equity - Reserved Ordinary Shares (Details) - shares | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2018 |
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 5,389,478 | 4,549,256 | |
Equity Incentive Plan, 2018 | |||
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 2,558,834 | 1,780,687 | 1,500,000 |
Options to purchase shares | |||
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 1,956,119 | 2,098,087 | |
Restricted Stock | |||
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 21,025 | 3,982 | |
ESPP | |||
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 848,000 | 661,000 | |
Rockport Warrants | |||
Class of Stock [Line Items] | |||
Shares reserved for future issuance (in shares) | 5,500 | 5,500 |
Warrants - Narrative (Details)
Warrants - Narrative (Details) - Rockport Warrants - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2017 |
Class of Stock [Line Items] | |||
Exercise price of warrants (in dollars per share) | $ 3.80 | $ 3.80 | |
Warrants outstanding (in shares) | 5,500 | 5,500 | |
Common Class B | |||
Class of Stock [Line Items] | |||
Number of shares called by warrants (in shares) | 145,000 |
Warrants - Warrant (Details)
Warrants - Warrant (Details) - Rockport Warrants - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2017 |
Class of Stock [Line Items] | |||
Shares (in shares) | 5,500 | 5,500 | |
Exercise Price (in dollars per share) | $ 3.80 | $ 3.80 |
Share-based Compensation - Narr
Share-based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2019 | Mar. 31, 2022 | Mar. 31, 2021 | Jan. 01, 2022 | Dec. 31, 2021 | Jan. 01, 2021 | Jan. 01, 2020 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares reserved for future issuance (in shares) | 5,389,478 | 4,549,256 | ||||||
Number of options vested and exercisable (in shares) | 894,656 | |||||||
Weighted average exercise price vested and exercisable (in dollars per share) | $ 21.26 | |||||||
Aggregate intrinsic value of options vested and exercisable | $ 41,500 | |||||||
Number of options exercised in period (in shares) | 113,821 | |||||||
Weighted average exercise price of options exercised (in dollars per share) | $ 14.96 | |||||||
Intrinsic value of options exercised in period | $ 5,000 | $ 7,300 | ||||||
Unrecognized compensation expense of stock options granted | $ 24,800 | |||||||
Unrecognized compensation expense period for recognition | 2 years 3 months 18 days | |||||||
Unrecognized share-based compensation cost of unvested RSAs | $ 3,434 | 1,757 | ||||||
Employee Stock Option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares reserved for future issuance (in shares) | 1,956,119 | 2,098,087 | ||||||
Vesting period | 4 years | |||||||
Unrecognized share-based compensation cost of unvested RSAs | $ 2,900 | 1,100 | ||||||
Restricted Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares reserved for future issuance (in shares) | 21,025 | 3,982 | ||||||
RSAs vested in period | $ 600 | 200 | ||||||
Unrecognized share-based compensation cost | $ 500 | |||||||
Employee unrecognized compensation expense, period for recognition | 6 months | |||||||
Minimum | Restricted Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting period | 1 year | |||||||
Maximum | Restricted Stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Vesting period | 4 years | |||||||
Consultant | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Unrecognized compensation expense of stock options to non-employees | $ 1,000 | |||||||
Issuance of stock and warrants for services or claims | $ 37 | $ 500 | ||||||
Equity Incentive Plan, 2018 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares reserved for future issuance (in shares) | 2,558,834 | 1,780,687 | 1,500,000 | |||||
Increase in common stock, shares authorized (in shares) | 750,000 | 750,000 | 750,000 | 750,000 | ||||
Common stock, capital shares reserved for future issuance, increase (decrease), percent | 4.00% | |||||||
Common Stock, Shares Authorized | 4,500,000 |
Share-based Compensation - Stoc
Share-based Compensation - Stock Options and Restricted Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 3,434 | $ 1,757 |
Sales, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 2,967 | 1,146 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 467 | $ 611 |
Share-based Compensation - St_2
Share-based Compensation - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Options Outstanding | ||
Balance outstanding (in shares) | 2,098,087 | |
Granted (in shares) | 11,045 | |
Exercised (in shares) | (113,821) | |
Forfeited/canceled (in shares) | (39,192) | |
Balance outstanding (in shares) | 1,956,119 | 2,098,087 |
Weighted average fair value (in dollars per share) | $ 45.54 | |
Weighted-Average Exercise Price | ||
Options outstanding (in dollars per share) | 37.49 | |
Granted (in dollars per share) | 33.44 | |
Exercised (in dollars per share) | 14.96 | |
Forfeited/canceled (in dollars per share) | 33.02 | |
Options outstanding (in dollars per share) | $ 38.87 | $ 37.49 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted-average remaining contractual term | 7 years 6 months 18 days | 7 years 8 months 1 day |
Aggregate intrinsic value | $ 60,107 | $ 67,357 |
Share-based Compensation - St_3
Share-based Compensation - Stock Option Granted to Employees (Details) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate, minimum | 0.70% | |
Risk-free interest rate, maximum | 1.10% | |
Employee | Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility | 59.00% | 60.00% |
Risk-free interest rate, maximum | 1.60% | |
Term (in years) | 6 years 3 months | 6 years 3 months |
Dividend yield | 0.00% | 0.00% |
Share-based Compensation - St_4
Share-based Compensation - Stock Options Granted to Non-employees (Details) - Non-employee - Employee Stock Option - Consultant | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Volatility | 60.00% |
Risk-free interest rate | 1.60% |
Term (in years) | 10 years |
Dividend yield | 0.00% |
Share-based Compensation - Rest
Share-based Compensation - Restricted Stock Activity (Details) - Restricted Stock | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
Restricted Stock Units | |
Outstanding balance (in shares) | shares | 3,982 |
Granted (in shares) | shares | 17,043 |
Vested (in shares) | shares | 0 |
Forfeited/canceled (in shares) | shares | 0 |
Outstanding balance (in shares) | shares | 21,025 |
Weighted- Average Grant Date Fair Value | |
Balance outstanding (in dollars per share) | $ / shares | $ 69.05 |
Granted (in dollars per share) | $ / shares | 49.87 |
Vested (in dollars per share) | $ / shares | 0 |
Forfeited/canceled (in dollars per share) | $ / shares | 0 |
Balance outstanding (in dollars per share) | $ / shares | $ 53.50 |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net loss | $ (5,933) | $ (6,948) |
Denominator: | ||
Weighted average outstanding shares used for basic net loss per share (in shares) | 24,310,856 | 23,827,137 |
Weighted average outstanding shares used for diluted net loss per share (in shares) | 24,310,856 | 23,827,137 |
Net loss per share: | ||
Basic net loss per share (in dollars per share) | $ (0.24) | $ (0.29) |
Diluted net loss per share (in dollars per share) | $ (0.24) | $ (0.29) |
Net Loss Per Share - Dilutive S
Net Loss Per Share - Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,795,144 | 1,949,010 |
Options to purchase common shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,768,619 | 1,900,825 |
Shares issuable on vesting of grants of restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 21,025 | 42,685 |
Warrants to purchase common shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 5,500 | 5,500 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Dec. 31, 2020 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2017 | |
Related Party Transaction [Line Items] | |||||
Grants in period (in shares) | 11,045 | ||||
Immediate Family Member of Management or Principal Owner | |||||
Related Party Transaction [Line Items] | |||||
Revenue from related parties | $ 400,000 | $ 200,000 | |||
Accounts receivable | 500,000 | $ 400,000 | |||
Cash reimbursement per day for services | $ 4,500 | ||||
Grants in period (in shares) | 22,068 | ||||
Vesting period | 4 years | ||||
Purchases from related party | $ 32,000 | $ 93,000 |
Subsequent Events - Narrative (
Subsequent Events - Narrative (Details) - Line of Credit - USD ($) | Apr. 26, 2022 | May 10, 2022 | Aug. 24, 2017 |
Credit Agreement | Forecast | |||
Subsequent Event [Line Items] | |||
Early repayment amount | $ 5,000,000 | ||
Credit Agreement | Forecast | Prior to Second Anniversary | |||
Subsequent Event [Line Items] | |||
Yield protection premium fee | 4.00% | ||
Credit Agreement | Forecast | Prior to Third Anniversary | |||
Subsequent Event [Line Items] | |||
Yield protection premium fee | 4.00% | ||
Credit Agreement | Forecast | Prior to Fourth Anniversary | |||
Subsequent Event [Line Items] | |||
Yield protection premium fee | 2.00% | ||
Credit Agreement | Forecast | Subsequent to Fourth Anniversary | |||
Subsequent Event [Line Items] | |||
Yield protection premium fee | 0.00% | ||
Amended Madryn Credit Agreement | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | $ 65,000,000 | ||
Subsequent Event | Credit Agreement | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | $ 225,000,000 | $ 150,000,000 | |
Debt term | 5 years | ||
Effective interest rate | 9.00% | ||
Original discount rate | 2.00% | ||
Exit fee | 3.00% | ||
Minimum liquidity requirement | $ 20,000,000 | ||
Minimum gross sales | $ 200,000,000 | ||
Minimum gross sales percentage | 50.00% | ||
Subsequent Event | Credit Agreement, Tranche A Term Loan | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | $ 150,000,000 | ||
Subsequent Event | Credit Agreement, Tranche B Term Loan | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | 25,000,000 | ||
Minimum liquidity requirement | 25,000,000 | ||
Subsequent Event | Credit Agreement, Tranche C Term Loan | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | 25,000,000 | ||
Subsequent Event | Credit Agreement, Tranche D Term Loan | |||
Subsequent Event [Line Items] | |||
Maximum borrowing capacity | $ 25,000,000 | ||
Effective interest rate | 8.25% | ||
Subsequent Event | Amended Madryn Credit Agreement | |||
Subsequent Event [Line Items] | |||
Debt repayment | $ 65,000,000 |