Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 17, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35280 | ||
Entity Registrant Name | VERICEL CORPORATION | ||
Entity Incorporation, State or Country Code | MI | ||
Entity Tax Identification Number | 94-3096597 | ||
Entity Address, Address Line One | 64 Sidney Street | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02139 | ||
City Area Code | 617 | ||
Local Phone Number | 588-5555 | ||
Title of 12(b) Security | Common Stock (No par value) | ||
Trading Symbol | VCEL | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,178,602,023 | ||
Entity Common Stock, Shares Outstanding | 47,364,276 | ||
Documents Incorporated by Reference | Document Form 10-K Reference Proxy Statement for the Annual Meeting of Shareholders for the fiscal year ended December 31, 2022, scheduled for May 3, 2023 Items 10, 11, 12, 13 and 14 of Part III | ||
Entity Central Index Key | 0000887359 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 238 |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | Boston, Massachusetts |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 51,067 | $ 68,330 |
Short-term investments | 68,471 | 35,068 |
Accounts receivable (net of allowance for doubtful accounts of $47 and $40, respectively) | 46,539 | 37,437 |
Inventory | 15,986 | 13,381 |
Other current assets | 4,803 | 4,246 |
Total current assets | 186,866 | 158,462 |
Property and equipment, net | 15,837 | 13,308 |
Intangible assets, net | 7,500 | 0 |
Restricted cash | 0 | 211 |
Right-of-use assets | 41,535 | 45,720 |
Long-term investments | 19,962 | 25,687 |
Other long-term assets | 1,303 | 317 |
Total assets | 273,003 | 243,705 |
Current liabilities: | ||
Accounts payable | 16,930 | 9,016 |
Accrued expenses | 16,190 | 14,045 |
Current portion of operating lease liabilities | 4,302 | 2,950 |
Other current liabilities | 41 | 41 |
Total current liabilities | 37,463 | 26,052 |
Operating lease liabilities | 43,268 | 47,147 |
Other long-term liabilities | 0 | 44 |
Total liabilities | 80,731 | 73,243 |
COMMITMENTS AND CONTINGENCIES (Note 15) | ||
Shareholders’ equity: | ||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 47,253 and 46,880, respectively | 593,245 | 553,902 |
Accumulated other comprehensive loss | (978) | (154) |
Accumulated deficit | (399,995) | (383,286) |
Total shareholders’ equity | 192,272 | 170,462 |
Total liabilities and shareholders’ equity | $ 273,003 | $ 243,705 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 47 | $ 40 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 47,253,000 | 46,880,000 |
Common stock, shares outstanding (in shares) | 47,253,000 | 46,880,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | |||
Revenue, Product and Service [Extensible List] | Product [Member] | Product [Member] | Product [Member] |
Product sales, net | $ 163,698 | $ 153,075 | $ 121,968 |
Other revenue | 667 | 3,109 | 2,211 |
Total revenue | $ 164,365 | $ 156,184 | $ 124,179 |
Cost, Product and Service [Extensible List] | Product [Member] | Product [Member] | Product [Member] |
Cost of product sales | $ 54,577 | $ 50,159 | $ 39,951 |
Gross profit | 109,788 | 106,025 | 84,228 |
Research and development | 19,943 | 16,287 | 13,020 |
Selling, general and administrative | 106,903 | 97,592 | 68,836 |
Total operating expenses | 126,846 | 113,879 | 81,856 |
(Loss) income from operations | (17,058) | (7,854) | 2,372 |
Other income (expense): | |||
Interest income | 1,341 | 224 | 691 |
Interest expense | (366) | (4) | (6) |
Other income (expense) | 95 | 52 | (13) |
Total other income | 1,070 | 272 | 672 |
(Loss) income before income taxes | (15,988) | (7,582) | 3,044 |
Income tax expense (benefit) | 721 | (111) | 180 |
Net (loss) income | $ (16,709) | $ (7,471) | $ 2,864 |
Net (loss) income per common share: | |||
Basic (in USD per share) | $ (0.35) | $ (0.16) | $ 0.06 |
Diluted (in USD per share) | $ (0.35) | $ (0.16) | $ 0.06 |
Weighted-average common shares outstanding: | |||
Basic (in shares) | 47,130 | 46,472 | 45,221 |
Diluted (in shares) | 47,130 | 46,472 | 47,282 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net (loss) income | $ (16,709) | $ (7,471) | $ 2,864 |
Other comprehensive (loss) income: | |||
Unrealized (loss) gain on investments | (824) | (168) | (7) |
Comprehensive (loss) income | $ (17,533) | $ (7,639) | $ 2,857 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Accumulated Other Comprehensive Gain (loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 44,864,000 | |||
Beginning balance at Dec. 31, 2019 | $ 111,091 | $ 489,749 | $ 21 | $ (378,679) |
Increase (Decrease) in Shareholders' Equity | ||||
Net (loss) income | 2,864 | 2,864 | ||
Stock-based compensation expense | 13,843 | $ 13,843 | ||
Stock option exercises (in shares) | 790,000 | |||
Stock option exercises | 5,582 | $ 5,582 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 117,000 | |||
Shares issued under the Employee Stock Purchase Plan | 1,050 | $ 1,050 | ||
Issuance of stock for restricted stock unit vesting (shares) | 47,000 | |||
Restricted stock withheld for employee tax remittance (in shares) | (14,000) | |||
Restricted stock withheld for employee tax remittance | (163) | $ (163) | ||
Unrealized loss on investments | (7) | (7) | ||
Ending balance (in shares) at Dec. 31, 2020 | 45,804,000 | |||
Ending balance at Dec. 31, 2020 | 134,260 | $ 510,061 | 14 | (375,815) |
Increase (Decrease) in Shareholders' Equity | ||||
Net (loss) income | (7,471) | (7,471) | ||
Stock-based compensation expense | 34,322 | $ 34,322 | ||
Stock option exercises (in shares) | 968,000 | |||
Stock option exercises | 9,928 | $ 9,928 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 43,000 | |||
Shares issued under the Employee Stock Purchase Plan | 1,256 | $ 1,256 | ||
Issuance of stock for restricted stock unit vesting (shares) | 96,000 | |||
Restricted stock withheld for employee tax remittance (in shares) | (31,000) | |||
Restricted stock withheld for employee tax remittance | (1,665) | $ (1,665) | ||
Unrealized loss on investments | $ (168) | (168) | ||
Ending balance (in shares) at Dec. 31, 2021 | 46,880,000 | 46,880,000 | ||
Ending balance at Dec. 31, 2021 | $ 170,462 | $ 553,902 | (154) | (383,286) |
Increase (Decrease) in Shareholders' Equity | ||||
Net (loss) income | (16,709) | (16,709) | ||
Stock-based compensation expense | $ 37,183 | $ 37,183 | ||
Stock option exercises (in shares) | 234,707 | 234,000 | ||
Stock option exercises | $ 2,401 | $ 2,401 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 49,000 | |||
Shares issued under the Employee Stock Purchase Plan | 1,251 | $ 1,251 | ||
Issuance of stock for restricted stock unit vesting (shares) | 134,000 | |||
Restricted stock withheld for employee tax remittance (in shares) | (44,000) | |||
Restricted stock withheld for employee tax remittance | (1,492) | $ (1,492) | ||
Unrealized loss on investments | $ (824) | (824) | ||
Ending balance (in shares) at Dec. 31, 2022 | 47,253,000 | 47,253,000 | ||
Ending balance at Dec. 31, 2022 | $ 192,272 | $ 593,245 | $ (978) | $ (399,995) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | |||
Net (loss) income | $ (16,709) | $ (7,471) | $ 2,864 |
Adjustments to reconcile net (loss) income to net cash flows from operating activities: | |||
Depreciation and amortization expense | 3,981 | 2,965 | 2,383 |
Stock-based compensation expense | 37,183 | 34,322 | 13,843 |
Amortization of premiums and discounts on marketable securities | 107 | 949 | 318 |
Amortization of debt issuance costs | 90 | 0 | 0 |
Non-cash lease costs | 4,222 | 4,422 | 4,445 |
Other | 22 | 7 | 93 |
Changes in operating assets and liabilities: | |||
Inventory | (2,605) | (4,025) | (2,540) |
Accounts receivable | (9,102) | (2,933) | (2,336) |
Other current assets | (557) | (353) | (940) |
Accounts payable | 1,437 | 1,491 | 33 |
Accrued expenses | 2,145 | 2,752 | 3,345 |
Operating lease liabilities | (2,527) | (3,086) | (3,951) |
Other non-current assets and liabilities, net | 0 | 0 | 15 |
Net cash provided by operating activities | 17,687 | 29,040 | 17,572 |
Investing activities: | |||
Purchases of investments | (69,554) | (60,021) | (63,057) |
Sales and maturities of investments | 40,944 | 64,435 | 48,523 |
Expenditures for property and equipment | (7,596) | (7,915) | (2,626) |
Net cash used in investing activities | (36,206) | (3,501) | (17,160) |
Financing activities: | |||
Net proceeds from common stock issuance | 3,652 | 11,184 | 6,632 |
Debt issuance costs | (1,076) | 0 | 0 |
Payments on employee's behalf for taxes related to vesting of restricted stock unit awards | (1,492) | (1,665) | (163) |
Other | (39) | (348) | (28) |
Net cash provided by financing activities | 1,045 | 9,171 | 6,441 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (17,474) | 34,710 | 6,853 |
Cash, cash equivalents, and restricted cash at beginning of period | 68,541 | 33,831 | 26,978 |
Cash, cash equivalents, and restricted cash at end of period | 51,067 | 68,541 | 33,831 |
Supplemental disclosure of cash flow information: | |||
Right-of-use asset and lease liability recognized | 137 | 192 | 29,573 |
Additions to property and equipment and intangible assets included in accounts payable | 7,824 | 1,373 | 531 |
Restricted stock held for employee tax remittance included in accounts payable | 0 | 46 | 0 |
Interest paid | 109 | 4 | 6 |
Taxes paid | 0 | 379 | 147 |
Reconciliation of amounts within the consolidated balance sheets: | |||
Cash and cash equivalents | 51,067 | 68,330 | 33,620 |
Restricted cash | 0 | 211 | 211 |
Total cash, cash equivalents, and restricted cash at end of period | $ 51,067 | $ 68,541 | $ 33,831 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Vericel Corporation, a Michigan corporation (together with its consolidated subsidiaries referred to herein as the Company, or Vericel), was incorporated in March 1989 and began employee-based operations in 1991. The Company is a fully-integrated, commercial-stage biopharmaceutical company and is a leader in advanced therapies for the sports medicine and severe burn care markets. Vericel currently markets three commercial-stage products in the U.S., MACI ® , Epicel ® and NexoBrid ® . MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel (cultured epidermal autografts) is a permanent skin replacement for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of total body surface area (“TBSA”). The Company also holds an exclusive license from MediWound Ltd. (“MediWound”) to commercialize NexoBrid (anacaulase-bcdb) in North America. On December 28, 2022, the U.S. Food and Drug Administration (“FDA”) approved a Biologics License Application (“BLA”) for NexoBrid, granting a license for commercial use in the U.S. NexoBrid is a topically-administered biological product containing proteolytic enzymes and is indicated for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. The Company operates its business primarily in the U.S. in one reportable segment - the research, product development, manufacture and distribution of cellular therapies and specialty biologics for use in the treatment of specific diseases. The Company is subject to risks common to companies in the life sciences industry including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, commercialization of existing and new products, and compliance with FDA regulations and approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies. COVID-19 In March 2020, the World Health Organization declared the spread of a novel strain of coronavirus (“COVID-19”) to be a pandemic. This pandemic has contributed to an economic downturn on a global scale, as well as significant volatility in the financial markets. Since the pandemic’s inception, and at times, there has been significant volatility in the Company’s results of operations on a quarterly basis due to the widespread and periodic cancellation or delay of elective MACI surgical procedures throughout the U.S., staffing shortages and the Company’s ability to access customers. The Company continues to manufacture MACI and Epicel and has begun efforts to commercialize NexoBrid in North America following the FDA’s approval of the submitted BLA on December 28, 2022. The Company maintains a significant safety stock of all key raw materials, and it does not expect that current global supply chain interruptions will impact the Company’s ongoing manufacturing operations of MACI and Epicel. Additionally, although the Company has not experienced material shipping delays, significant disruption of air travel could result in the inability to deliver MACI or Epicel final products to customer sites within appropriate timeframes, which could adversely impact its business. Currently, the Company is not aware of COVID-19 related impacts on its distributors, operations or third-party service providers’ ability to manage patient cases. With the recent FDA approval of NexoBrid, MediWound has begun preparations to manufacture and supply sufficient quantities of NexoBrid to meet customer demand. To date, MediWound has not indicated that it expects pandemic-related disruptions to affect its ability to manufacture and supply NexoBrid. The Company believes that a resurgence of COVID-19 because of emerging variants or other factors could result in additional disruptions that could impact its business and operations in the future, including intermittent restrictions on the ability of its personnel to travel and access customers for selling, marketing, training, case support and product development feedback, delays in approvals by regulatory bodies, delays in product development efforts, and additional government requirements or other incremental mitigation efforts that may further impact its capacity to manufacture, sell and support the use of its products. The War in Ukraine The ongoing war between Russia and Ukraine and the related sanctions and other penalties imposed by countries across the globe against Russia are continuing to create substantial uncertainty in the global economy and have contributed to heightened inflation and supply chain disruptions. While the Company does not have operations in Russia or Ukraine and does not have exposure to distributors, or third-party service providers in Russia or Ukraine, it is unable to predict the ultimate impact that these actions will have on the global economy or on its financial condition, results of operations, and cash flows as of the date of these consolidated financial statements. Liquidity The accompanying consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of December 31, 2022, the Company had an accumulated deficit of $400.0 million and had a net loss of $16.7 million for the year ended December 31, 2022. The Company had cash and cash equivalents of $51.1 million and investments of $88.4 million as of December 31, 2022. The Company expects that cash from the sales of its products and existing cash, cash equivalents, investments, and available borrowing capacity will be sufficient to support the Company’s current operations through at least 12 months from the issuance of these consolidated financial statements. To the extent the U.S. experiences a worsening in COVID-19 infections or additional virus variants emerge that result in more serious disease or limit the effectiveness of existing vaccines, however subsequent healthcare measures – to include the postponement or cessation of elective and other surgical procedures – may cause the Company to experience a reduction in business and resulting revenue. This, consequently, may result in irrecoverable losses of customers and significantly impact the Company’s long-term liquidity, potentially requiring the Company to engage in layoffs, furloughs and/or reductions in salaries. The Company also may need to access additional capital; however, the Company may not be able to obtain additional financing on acceptable terms or at all, particularly in light of the various negative impacts on the global economy and financial markets, which are currently being experienced. The terms of any additional financing may adversely affect the holdings or the rights of the Company’s shareholders. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The more significant estimates reflected in the Company’s consolidated financial statements include, but are not limited to, certain judgments regarding revenue recognition, inventory valuation, stock option valuation, deferred tax assets and liabilities and accrued expenses. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments reflected in these consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance of these consolidated financial statements. These estimates may change as new events occur and additional information is obtained. Actual results could materially differ from those estimates. Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase and consist primarily of demand deposits, money market funds, U.S. government agency bonds and commercial paper. Restricted Cash Amounts included in restricted cash as of December 31, 2021, represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. Investments Investments classified as short-term have maturities of less than one year. Investments classified as long-term are those that: (i) have a maturity of greater than one year, and (ii) the Company does not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale. The Company’s investment strategy is to buy short-duration marketable securities with a high credit rating. As of December 31, 2022 and 2021, all marketable securities held by the Company had remaining contractual maturities of three years or less. Unrealized gains are included as a component of accumulated other comprehensive income in the consolidated balance sheets and consolidated statements of shareholders’ equity and a component of total comprehensive (loss) income in the consolidated statements of comprehensive (loss) income, until realized. Unrealized losses are evaluated for impairment under ASC 326 , Financial Instruments - Credit Losses (“ASC 326”), to determine if the impairment is credit-related or non-credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and non-credit-related impairment is recognized in other comprehensive (loss) income, net of taxes. Leases The Company determines if an arrangement is a lease at inception, in accordance with ASC Topic 842, Leases . All operating lease commitments with a lease term greater than 12 months are recognized as right-of-use assets and liabilities, on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Certain of the Company’s lease agreements include lease payments that are adjusted periodically for an index or rate. The leases are initially measured using the present value of the projected payments adjusted for the index or rate in effect at the commencement date. In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance and other expenses, which do not transfer a good or service to the Company and are generally referred to as non-lease components. Variable non-lease components are not measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. The Company has options to renew lease terms for facilities and other assets. Some leases contain clauses for renewal at the Company’s option with renewal terms that generally extend the lease term from 1 to 5 years. The exercise of lease renewal options is generally at the Company’s sole discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option on the basis of economic factors. Certain lease agreements contain options to purchase the leased property and options to terminate the lease. A portfolio approach is applied to certain lease contracts with similar characteristics. Inventory Inventories are measured at the lower of cost or net realizable value. Cost is calculated based upon standard-cost which approximates costs determined on the first-in, first-out method. The Company periodically reviews its inventories for excess or obsolescence and writes down obsolete or other unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts written down are charged to cost of product sales. Accounts Receivable Accounts receivable are initially recorded at the contractual amount owed by the customer or based on expected payments from the insurance provider, hospital or patient. Allowances for doubtful accounts are established when the facts and circumstances indicate that a receivable may not be collectible. Potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326 . The Company assesses risk and determines a loss percentage by pooling accounts receivable based on similar risk characteristics. The loss percentage is calculated through the use of forecasts that are based on current and historical economic and financial information. Property and Equipment, net Property and equipment are initially measured and recognized at acquisition cost, including any directly attributable cost of preparing the asset for its intended use. After initial measurement, property and equipment are carried at cost less accumulated depreciation. Repair and maintenance costs of property and equipment are expensed as incurred. The depreciable value of property and equipment is depreciated on a straight-line basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life. The useful lives of property and equipment are as follows: • Machinery and equipment: 3 to 10 years • Furniture, fixtures and office equipment: 5 years • Computer equipment and software: 3 years • Leasehold improvements: shorter of the remaining life of the lease or 15 years The costs of assets retired or otherwise disposed of and the accumulated depreciation thereon are removed from the accounts, with any gain or loss realized upon sale or disposal credited or charged to operations. Intangible Assets, net The Company amortizes its intangible assets on a straight-line basis over their estimated economic lives, unless another amortization method is deemed to be more appropriate. In determining the useful lives of intangible assets, the Company considers the expected use of the assets and the effects of obsolescence, demand, competition, anticipated technological advances, market influence and other economic factors. Intangible assets are assessed for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. If it is determined that the carrying amount of an asset is not recoverable, an impairment loss is recorded as a permanent reduction in the amount by which the carrying amount of the asset exceeds its fair value. Revenue Recognition The Company recognizes product revenue from sales to a customer (whether a distributor, or hospital) following the five step model in Accounting Standards Codification 606, Revenue Recognition (“ ASC 606”): (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Under this revenue standard, the Company recognizes revenue when its customer obtains control of the promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. There are no contractual rights of returns, refunds or similar obligations related to MACI, MACI biopsy kits, Epicel or NexoBrid; however, in certain limited cases the Company will accept a product return if a surgery is canceled. Revenue is not recognized in certain canceled cases. For MACI, MACI biopsy kits, Epicel and NexoBrid, there are no variable pricing arrangements related to warranties or rebates offered to customers. The majority of orders are due within 60 to 90 days of delivery. Shipping and handling fees are included as a component of revenue. The Company recognizes any commission fees as an expense when incurred. These fees are included in selling, general, and administrative expenses. See Note 3, “Revenue” for further discussion on revenues. Research and Development Expense Research and development expenses are expensed as incurred. These expenditures relate to the development of new products, improvement of existing products, technical support of products and compliance with governmental regulations for the protection of consumers and patients. Stock-Based Compensation The Company’s accounting for stock-based compensation requires it to determine the fair value of common stock issued in the form of stock option awards and restricted stock units. The fair value of restricted stock units held by the employees is determined based on the fair value of the Company’s common stock on the date of the grant. Compensation expense is recorded for restricted stock units that are expected to vest over the expected vesting period. The fair value of stock options held by the employees is determined using a Black-Scholes option valuation method. Key assumptions in determining fair value include volatility, risk-free interest rate, dividend yield and expected term. The assumptions used in calculating the fair value of stock options represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and different assumptions are used, the stock-based compensation expense could be materially different in the future. In addition, the Company estimates the expected forfeiture rate and only recognizes expense for those stock options expected to vest over the service period. The estimated forfeiture rate considers the historical experience of the Company’s stock-based awards. If the actual forfeiture rate is different from the estimate, expense is adjusted accordingly. The Company records the expense for stock options and restricted stock units using a graded-vesting attribution method. The Company also has an Employee Stock Purchase Plan (“ESPP”) which is a compensatory plan. Compensation expense is recorded based on the fair value of the purchased options at the grant date, which corresponds to the first day of each purchase period, and is amortized over the purchase period. Comprehensive (Loss) Income Comprehensive (loss) income is the change in shareholders’ equity during a period arising from unrealized gains or losses related to the Company’s investments. Income Taxes Deferred tax assets are recognized for deductible temporary differences and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized based on the weight of available evidence. When evaluating the realizability of the deferred tax assets, all evidence, both positive and negative, is considered. Items considered when evaluating the need for a valuation allowance include the ability to carry back losses, future reversals of existing temporary differences, tax planning strategies, and expectations of future earnings. The Company records uncertain tax positions in the consolidated financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense. Net (Loss) Income Per Common Share Basic earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period, plus the potential dilutive effect of other securities if those securities were converted or exercised. During periods in which the Company incurs net losses, both basic and diluted loss per common share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding and potentially dilutive securities are excluded from the calculation because their effect would be antidilutive. Financial Instruments The Company’s financial instruments include accounts receivables, accounts payable and accrued expenses for which the current carrying amounts approximate market value, based upon their short-term nature and marketable debt securities which are classified as available-for-sale and carried at fair value on a settlement date basis. Recent Accounting Pronouncements No new accounting standards were adopted during the year ended December 31, 2022. The Company considers the applicability and impact of any recent Accounting Standards Update (“ASU”) issued by the Financial Accounting Standards Board (“FASB”). Based on the assessment, the ASU’s were determined to be either not applicable or are expected to have minimal impact on the Company's consolidated financial statements. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Risks and Uncertainties [Abstract] | |
Revenue | Revenue Revenue Recognition and Product Sales, Net As disclosed in Note 2, the Company recognizes product revenue from sales of MACI biopsy kits, MACI implants, Epicel grafts and other sources following the five-step model in Accounting Standards Codification 606, Revenue Recognition. MACI Biopsy Kits MACI biopsy kits are sold directly to hospitals and ambulatory surgical centers based on contracted rates in an approved contract or sales order. The Company recognizes MACI kit revenue upon delivery of the biopsy kit, at which time the customer (the facility) is in control of the kit. The kit is used by the doctor to provide a sample of cartilage tissue to the Company, which can later be used to manufacture a MACI implant. The ordering of the kit does not obligate the Company to manufacture an implant nor does the receipt of the cartilage tissue by the Company from the customer following biopsy. The customer’s order of an implant is separate from the process of ordering the biopsy kit. Therefore, the sale of the biopsy kit and any subsequent sale of an implant are distinct contracts and are accounted for separately. MACI Implants The Company contracts with two specialty pharmacies, Orsini Pharmaceutical Services, Inc. (“Orsini”) and AllCare Plus Pharmacy, Inc. (“AllCare”) to distribute MACI in a manner in which the Company retains the credit and collection risk from the end customer. The Company pays both specialty pharmacies a fee for each patient to whom MACI is dispensed. Both Orsini and AllCare perform collection activities to collect payment from customers. The Company engages a third-party to provide services in connection with a patient support program to manage patient cases and to ensure complete and correct billing information is provided to the insurers and hospitals. In addition, the Company also sells MACI directly to DMS Pharmaceutical Group, Inc. (“DMS”) for patients treated at military treatment facilities. The sales directly to DMS are made at a contracted rate. Prior authorization and confirmation of coverage level by the patient’s private insurance plan, hospital or government payer is a prerequisite to the shipment of product to a patient. The Company recognizes product revenue from sales of all MACI implants upon delivery at which time the customer obtains control of the implant and the claim is billable. The total consideration that the Company expects to collect in exchange for MACI implants (the “Transaction Price”) may be fixed or variable. Direct sales to hospitals or distributors are recorded at a contracted price, and there are typically no forms of variable consideration. When the Company sells MACI the patient is responsible for payment; however, the Company is typically reimbursed by a third-party insurer or government payer, subject to a patient co-pay amount. Reimbursements from third-party insurers and government payers vary by patient and payer and are based on either contracted rates, publicly available rates, fee schedules or past payer precedents. Net product revenue is recognized net of estimated contractual allowances, which considers historical collection experience from both the payer and patient, denial rates and the terms of the Company’s contractual arrangements. The Company estimates expected collections for these transactions using the portfolio approach. The Company records a reduction to revenue at the time of sale for its estimate of the amount of consideration that will not be collected. In addition, potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326. The Company assesses risk and determines a loss percentage by pooling accounts receivable based on similar risk characteristics. The loss percentage is calculated through the use of forecasts that are based on current and historical economic and financial information. This loss percentage was applied to the accounts receivables as of December 31, 2022. The total allowance for uncollectible consideration was $6.1 million and $7.0 million as of December 31, 2022, and 2021, respectively. Changes to the estimate of the amount of consideration that will not be collected could have a material impact to the revenue recognized. A 50 basis points change to the estimated uncollectible percentage could result in approximately $0.4 million decrease or increase in the revenue recognized for the year ended December 31, 2022. Changes in estimates of the Transaction Price are recorded through revenue in the period in which such change occurs. Changes in estimates related to prior periods are shown in the Revenue by Product and Customer table below and relate primarily to changes in the initial expected reimbursement or collection expectation upon completion of the billing claims process for MACI implants that occurred in a prior year. Epicel The Company sells Epicel directly to hospitals and burn centers based on contracted rates stated in an approved contract or purchase order. Similar to MACI, there is no obligation to manufacture Epicel grafts upon receipt of a skin biopsy, and Vericel has no contractual right to receive payment until the product is delivered to the hospital. The Company recognizes product revenue from sales of Epicel upon delivery to the hospital, at which time the customer is in control of the Epicel grafts and the claim is billable to the hospital. NexoBrid The Company entered into exclusive license and supply agreements with MediWound in May 2019, pursuant to which MediWound will manufacture and supply NexoBrid on a unit price basis, which may be increased pursuant to the terms of the agreements. Additionally, since 2020 the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) has been procuring NexoBrid from MediWound, for use as a medical countermeasure in the event of a mass casualty emergency in the U.S. involving thermal burns. That quarterly procurement of NexoBrid by BARDA under its agreement with MediWound completed during the third quarter of 2022, although BARDA holds an option to procure additional quantities of NexoBrid for emergency response preparedness in the future. As of December 31, 2022, the Company did not hold a direct contract or distribution agreement with BARDA, or take title to the product procured by BARDA. The Company recognized revenue based on a percentage of gross profits for sales of NexoBrid to BARDA upon delivery, at which time BARDA is in control of the product. Additionally, on December 28, 2022, the FDA approved a BLA for NexoBrid, granting a license for commercial use in the U.S. NexoBrid is a topically-administered biological product containing proteolytic enzymes and is indicated for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. Revenue by Product and Customer The following table and descriptions below shows the products from which the Company generated its revenue: Year Ended December 31, Revenue by product (in thousands) 2022 2021 2020 MACI implants and kits Implants based on contracted rate sold through a specialty pharmacy (a) $ 81,388 $ 71,969 $ 57,593 Implants subject to third party reimbursement sold through a specialty pharmacy (b) 18,695 16,000 16,320 Implants sold direct based on contracted rates (c) 24,261 18,714 15,144 Implants sold direct subject to third-party reimbursement (d) 3,499 2,821 2,754 Biopsy kits - direct bill 2,090 2,194 1,908 Change in estimates related to prior periods (e) 2,034 (144) 713 Total MACI implants and kits 131,967 111,554 94,432 Epicel Direct bill (hospital) 31,731 41,521 27,536 NexoBrid revenue (f) 667 3,109 2,211 Total revenue $ 164,365 $ 156,184 $ 124,179 (a) Represents implants sold through Orsini and AllCare whereby such specialty pharmacies have a direct contract with the underlying insurance provider. The amount of reimbursement is based on contracted rates at the time of sale supported by the pharmacy’s direct contracts. (b) Represents implants sold through Orsini and AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer and are subject to third-party reimbursement. The amount of reimbursement is established based on publicly available rates, fee schedules or past payer precedents. (c) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. Also represents direct sales under a contract to specialty distributor DMS. (d) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. The payment terms are subject to third-party reimbursement from an underlying insurance provider. (e) Primarily represents changes in estimates related to implants sold through Orsini or AllCare and relate to changes to the initial expected reimbursement or collection expectation upon completion of the billing claims process. The change in estimates is a result of additional information, changes in collection expectations or actual cash collections received in the current period. (f) Represents revenue based on a percentage of gross profits for sales of NexoBrid to BARDA, pursuant to the license agreement between the Company and MediWound (see note 14). Concentration of Credit Risk The Company’s total revenue and accounts receivable concentration from a MACI customer for the year ended and as of December 31, 2022 was 12% and 10%, respectively. There was no revenue concentration for the years ended December 31, 2021 or 2020, greater than 10%. For the Company’s total accounts receivable balances, there were no customers as of December 31, 2021 with a concentration greater than 10%. |
Selected Balance Sheet Componen
Selected Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Selected Balance Sheet Components | Selected Balance Sheet Components Inventory Inventory consisted of the following: December 31, (In thousands) 2022 2021 Raw materials $ 15,101 $ 12,676 Work-in-process 832 644 Finished goods 53 61 Total inventory $ 15,986 $ 13,381 Property and Equipment Property and Equipment, net consisted of the following: December 31, (In thousands) 2022 2021 Machinery and equipment $ 5,041 $ 4,522 Furniture, fixtures and office equipment 1,710 1,551 Computer equipment and software 8,224 7,769 Leasehold improvements 13,689 10,617 Construction in process 5,438 3,097 Financing right-of-use lease 37 74 Total property and equipment, gross 34,139 27,630 Less accumulated depreciation (18,302) (14,322) Total property and equipment, net $ 15,837 $ 13,308 Depreciation expense for the years ended December 31, 2022, 2021 and 2020 was $4.0 million, $3.0 million and $2.4 million, respectively. Intangible Assets The Company’s intangible assets of $7.5 million is comprised of a license for NexoBrid, as a result of regulatory approval received on December 28, 2022. The intangible will be amortized to cost of goods sold using a straight-line method over its expected twelve-year economic useful life. There was no amortization expense recognized during the year ended December 31, 2022. Future amortization expense of intangible assets as of December 31, 2022 is estimated to be as follows: (In thousands) Amount 2023 $ 625 2024 625 2025 625 2026 625 2027 625 Thereafter 4,375 Total $ 7,500 Accrued Expenses Accrued Expenses consisted of the following: December 31, (In thousands) 2022 2021 Bonus related compensation $ 7,132 $ 6,305 Employee related accruals 3,101 3,616 Insurance reimbursement-related liabilities 5,030 3,973 Other accrued expenses 927 151 Total accrued expenses $ 16,190 $ 14,045 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company leases facilities in Ann Arbor, Michigan and Cambridge, Massachusetts. The Ann Arbor facility includes office space, and the Cambridge facilities include clean rooms, laboratories for MACI and Epicel manufacturing and office space. The Company also leases offsite warehouse space, and other computer-related equipment. On January 28, 2022, the Company entered into a lease agreement (the “Burlington Lease”) to lease approximately 126,000 square feet of to-be-constructed manufacturing, laboratory and office space in Burlington, Massachusetts (the “Premises”). Once constructed, the Premises will serve as the Company’s new corporate headquarters and primary manufacturing facility. The term of the Burlington Lease is currently expected to begin in 2023, 12 months following the landlord’s commencement of construction of the core and shell of the building in which the Premises are located (the “Commencement Date”). The Company’s obligation to pay rent for the Premises will begin on the earlier of: 13 months from the Commencement Date; or the date on which the Company first occupies the Premises to conduct operations (the “Rent Commencement Date”). The initial term of the Lease is 144 months following the Rent Commencement Date. The Company has a one-time option to extend the term of the Lease for an additional 10 years, exercisable under certain conditions and at a market rate determined in accordance with the Burlington Lease. The annual base rent of the Burlington Lease is initially $57 per square foot per year, subject to annual increases of 2.5%. Monthly contractual payments are expected to range from $0.6 million to $0.8 million. Additionally, the Company is responsible for reimbursing the landlord for the Company’s share of the Premises’ property taxes and certain other operating expenses. The Burlington Lease also provides for a tenant improvement allowance from the landlord in an amount equal to $200 per square foot of the Premises, or approximately $25.1 million in total, towards the design and construction of certain tenant improvements made to the Premises, subject to the terms set forth in the Burlington Lease. The Company is not involved in the initial construction of the core and shell of the building and will record the lease liability and right-of-use asset on its consolidated balance sheet when the construction is substantially completed and it obtains control of the Premises, which is currently expected to be on or around the Commencement Date. In January 2022, in connection with the execution of the Burlington Lease, the Company issued a letter of credit collateralized by cash deposits of approximately $6.0 million. Subsequent to the execution of the Revolving Credit Agreement on July 29, 2022, the letter of credit is issued under the sub-facility limit of the Revolving Credit Agreement. Such letter of credit shall be reduced to approximately $4.2 million and $1.8 million at the conclusion of the third and sixth lease years, respectively, provided certain conditions set forth in the Burlington Lease are satisfied. For the year ended December 31, 2022 and 2021, lease expense of less than $0.1 million was recorded related to short-term leases. For the years ended December 31, 2022, 2021 and 2020, the Company recognized $6.9 million, $7.3 million and $6.3 million, respectively, of operating lease expense. For the years ended December 31, 2022, 2021 and 2020, the Company recognized less than $0.1 million of financing lease expense. Operating and finance lease assets and liabilities are as follows: December 31, (In thousands) Classification 2022 2021 Assets Operating Right-of-use assets $ 41,535 $ 45,720 Finance Property and equipment, net 37 73 Total leased assets $ 41,572 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,302 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,268 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 47,611 $ 50,182 Cash paid for amounts included in the measurement of the Company’s operating lease liabilities was $5.3 million, $6.0 million, and $5.8 million for the year ended December 31, 2022, 2021, and 2020, respectively. Future minimum lease payments under non-cancellable leases as of December 31, 2022 are as follows: (In thousands) Operating Leases Finance Leases Total 2023 $ 4,302 $ 41 $ 4,343 2024 6,946 — 6,946 2025 6,348 — 6,348 2026 6,530 — 6,530 2027 6,726 — 6,726 Thereafter 30,251 — 30,251 Total lease payments $ 61,103 $ 41 $ 61,144 Less: interest (13,533) — (13,533) Present value of lease liabilities (a) $ 47,570 $ 41 $ 47,611 (a) As of December 31, 2022, the Burlington Lease has not yet commenced. The Burlington Lease has future minimum lease payments of approximately $98.9 million and a tenant improvement allowance of $25.1 million with a lease term of 144 months. These undiscounted amounts are not included in this table. An explicit rate is not provided in some of the Company’s leases, therefore the Company uses a mix of incremental borrowing rates based on the information available at commencement date through market sources including relevant peer borrowing rates, as well as implicit and explicit rates in determining the present value of lease payments. Lease terms and discount rates are as follows: December 31, 2022 2021 Weighted-average remaining lease term (years) Operating leases 8.9 9.8 Finance leases 0.5 1.5 Weighted-average discount rate Operating leases 5.4% 5.4% Finance leases 5.0% 5.0% |
Leases | Leases The Company leases facilities in Ann Arbor, Michigan and Cambridge, Massachusetts. The Ann Arbor facility includes office space, and the Cambridge facilities include clean rooms, laboratories for MACI and Epicel manufacturing and office space. The Company also leases offsite warehouse space, and other computer-related equipment. On January 28, 2022, the Company entered into a lease agreement (the “Burlington Lease”) to lease approximately 126,000 square feet of to-be-constructed manufacturing, laboratory and office space in Burlington, Massachusetts (the “Premises”). Once constructed, the Premises will serve as the Company’s new corporate headquarters and primary manufacturing facility. The term of the Burlington Lease is currently expected to begin in 2023, 12 months following the landlord’s commencement of construction of the core and shell of the building in which the Premises are located (the “Commencement Date”). The Company’s obligation to pay rent for the Premises will begin on the earlier of: 13 months from the Commencement Date; or the date on which the Company first occupies the Premises to conduct operations (the “Rent Commencement Date”). The initial term of the Lease is 144 months following the Rent Commencement Date. The Company has a one-time option to extend the term of the Lease for an additional 10 years, exercisable under certain conditions and at a market rate determined in accordance with the Burlington Lease. The annual base rent of the Burlington Lease is initially $57 per square foot per year, subject to annual increases of 2.5%. Monthly contractual payments are expected to range from $0.6 million to $0.8 million. Additionally, the Company is responsible for reimbursing the landlord for the Company’s share of the Premises’ property taxes and certain other operating expenses. The Burlington Lease also provides for a tenant improvement allowance from the landlord in an amount equal to $200 per square foot of the Premises, or approximately $25.1 million in total, towards the design and construction of certain tenant improvements made to the Premises, subject to the terms set forth in the Burlington Lease. The Company is not involved in the initial construction of the core and shell of the building and will record the lease liability and right-of-use asset on its consolidated balance sheet when the construction is substantially completed and it obtains control of the Premises, which is currently expected to be on or around the Commencement Date. In January 2022, in connection with the execution of the Burlington Lease, the Company issued a letter of credit collateralized by cash deposits of approximately $6.0 million. Subsequent to the execution of the Revolving Credit Agreement on July 29, 2022, the letter of credit is issued under the sub-facility limit of the Revolving Credit Agreement. Such letter of credit shall be reduced to approximately $4.2 million and $1.8 million at the conclusion of the third and sixth lease years, respectively, provided certain conditions set forth in the Burlington Lease are satisfied. For the year ended December 31, 2022 and 2021, lease expense of less than $0.1 million was recorded related to short-term leases. For the years ended December 31, 2022, 2021 and 2020, the Company recognized $6.9 million, $7.3 million and $6.3 million, respectively, of operating lease expense. For the years ended December 31, 2022, 2021 and 2020, the Company recognized less than $0.1 million of financing lease expense. Operating and finance lease assets and liabilities are as follows: December 31, (In thousands) Classification 2022 2021 Assets Operating Right-of-use assets $ 41,535 $ 45,720 Finance Property and equipment, net 37 73 Total leased assets $ 41,572 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,302 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,268 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 47,611 $ 50,182 Cash paid for amounts included in the measurement of the Company’s operating lease liabilities was $5.3 million, $6.0 million, and $5.8 million for the year ended December 31, 2022, 2021, and 2020, respectively. Future minimum lease payments under non-cancellable leases as of December 31, 2022 are as follows: (In thousands) Operating Leases Finance Leases Total 2023 $ 4,302 $ 41 $ 4,343 2024 6,946 — 6,946 2025 6,348 — 6,348 2026 6,530 — 6,530 2027 6,726 — 6,726 Thereafter 30,251 — 30,251 Total lease payments $ 61,103 $ 41 $ 61,144 Less: interest (13,533) — (13,533) Present value of lease liabilities (a) $ 47,570 $ 41 $ 47,611 (a) As of December 31, 2022, the Burlington Lease has not yet commenced. The Burlington Lease has future minimum lease payments of approximately $98.9 million and a tenant improvement allowance of $25.1 million with a lease term of 144 months. These undiscounted amounts are not included in this table. An explicit rate is not provided in some of the Company’s leases, therefore the Company uses a mix of incremental borrowing rates based on the information available at commencement date through market sources including relevant peer borrowing rates, as well as implicit and explicit rates in determining the present value of lease payments. Lease terms and discount rates are as follows: December 31, 2022 2021 Weighted-average remaining lease term (years) Operating leases 8.9 9.8 Finance leases 0.5 1.5 Weighted-average discount rate Operating leases 5.4% 5.4% Finance leases 5.0% 5.0% |
Investments
Investments | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Investments | Investments Marketable debt securities held by the Company are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities , and carried at fair value in the accompanying consolidated balance sheets on a settlement date basis. The following tables summarize the gross unrealized gains and losses of the Company’s marketable securities as of December 31, 2022 and 2021: December 31, 2022 Gross Unrealized (In thousands) Amortized Cost Gains Losses Credit Losses Estimated Fair Value Commercial paper $ 15,707 $ — $ (101) $ — $ 15,606 Corporate notes 52,159 — (831) — 51,328 U.S. government agency bonds 21,545 — (46) — 21,499 $ 89,411 $ — $ (978) $ — $ 88,433 Classified as: Short-term investments $ 68,471 Long-term investments 19,962 $ 88,433 December 31, 2021 Gross Unrealized (In thousands) Amortized Cost Gains Losses Credit Losses Estimated Fair Value Commercial paper $ 10,243 $ — $ (12) $ — $ 10,231 Corporate notes 50,666 — (142) — 50,524 $ 60,909 $ — $ (154) $ — $ 60,755 Classified as: Short-term investments $ 35,068 Long-term investments 25,687 $ 60,755 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock Option, Restricted Stock Units and Equity Incentive Plans The Company has historically had various stock incentive plans and agreements that provide for the issuance of non-qualified and incentive stock options and restricted stock units as well as other equity awards. Such awards may be granted by the Company’s Board of Directors to certain of the Company’s employees, directors and consultants. Options and restricted stock units granted to employees and non-employees under these plans expire no later than ten years from the date of grant. Options and restricted stock units generally become exercisable or vest over a four year period (other than options and restricted stock units awarded annually to non-employee directors, which generally vest over one year, and options and restricted stock units awarded to non-employee directors upon initial appointment to the Vericel Board of Directors, which generally vest over a three year period), under a graded-vesting methodology for stock options and annually on the anniversary grant date for restricted stock units, following the date of grant. The Company generally issues new shares upon the exercise of stock options or vesting of restricted stock units. The Vericel Corporation 2022 Omnibus Incentive Plan (“2022 Plan”) was approved on April 27, 2022, and provides incentives through the grant of stock options, stock appreciation rights, restricted stock awards and restricted stock units. The exercise price of stock options granted under the 2022 Plan shall not be less than the fair market value of the Company’s common stock on the date of grant. The 2022 Plan replaced the 1992 Stock Option Plan, the 2001 Stock Option Plan, the Amended and Restated 2004 Equity Incentive Plan, the 2009 Second Amended and Restated Omnibus Incentive Plan, the 2017 Omnibus Incentive Plan, and the Amended and Restated 2019 Omnibus Incentive Plan (“Prior Plans”), and no new grants have been granted under the Prior Plans after approval of the 2022 Plan. However, the expiration or forfeiture of options previously granted under the Prior Plans will increase the number of shares available for issuance under the 2022 Plan. As of December 31, 2022, there were 3,818,536 shares available for future grant under the 2022 Plan. Stock Compensation Expense Non-cash stock-based compensation expense (service-based stock options, restricted stock units and employee stock purchase plan) is summarized in the following table: Years Ended December 31, (in thousands) 2022 2021 2020 Cost of product sales $ 3,630 $ 3,681 $ 1,949 Research and development 5,261 4,120 1,884 Selling, general and administrative 28,292 26,521 10,010 Total non-cash stock-based compensation expense $ 37,183 $ 34,322 $ 13,843 Service-Based Stock Options The fair value of each service-based stock option grant for the reported periods is estimated on the date of the grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Year Ended December 31, Service-Based Stock Options 2022 2021 2020 Expected dividend rate —% —% —% Expected stock price volatility 63.8 - 75.3% 71.5 - 76.7% 71.1 - 78.7% Risk-free interest rate 1.5 - 4.4% 0.53 -1.5% 0.33 -1.7% Expected life (years) 5.3 - 6.3 5.3 - 6.3 5.3 - 6.3 The weighted-average grant-date fair value of service-based options granted during the years ended December 31, 2022, 2021, and 2020 was $19.83, $32.96 and $8.86, respectively. The following table summarizes the activity for service-based stock options for the indicated periods: Service-Based Stock Options Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2021 5,669,690 $ 22.49 7.2 $ 113,985 Granted 1,348,824 33.37 Exercised (234,707) 10.22 Expired (31,436) 36.20 Forfeited (143,224) 31.42 Outstanding at December 31, 2022 6,609,147 $ 24.89 6.8 $ 56,708 Exercisable at December 31, 2022 4,205,883 $ 18.49 5.8 $ 51,204 As of December 31, 2022, 6,311,629 shares are vested and expected to vest. As of December 31, 2022, there was approximately $31.6 million of total unrecognized compensation cost related to non-vested service-based stock options granted under the 2022 Plan and the Prior Plans. That cost is expected to be recognized over a weighted-average period o f 2.7 y ears. The total intrinsic value of stock options exercised for the years ended December 31, 2022, 2021, and 2020 was $5.4 million, $39.5 million and $10.5 million, respectively. Restricted Stock Units The following table summarizes the activity for restricted stock units for the indicated periods: Restricted Stock Units Number of Restricted Stock Units Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 398,748 $ 36.30 Granted 422,958 33.71 Vested (135,380) 35.45 Forfeited (38,152) 34.98 Unvested at December 31, 2022 648,174 $ 34.86 The weighted-average grant-date fair value of restricted stock units granted during the years ended December 31, 2022, 2021, and 2020 was $33.71, $52.07 and $11.41, respectively. At December 31, 2022 the total unrecognized compensation cost related to the restricted stock units was $13.2 million, and the weighted-average period over which that cost is expected to be recognized was 2.8 years . The total fair value of restricted stock units vested in the years ended December 31, 2022 and 2021 was $4.6 million and $5.3 million, respectively. Employee Stock Purchase Plan |
Revolving Credit Agreement
Revolving Credit Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Revolving Credit Agreement | Revolving Credit AgreementOn July 29, 2022, the Company, as borrower, entered into a $150.0 million five-year senior secured revolving credit agreement by and among the Company, the other loan parties thereto, the lenders party thereto, and JPMorgan Chase Bank, N.A., as the administrative agent (the “Revolving Credit Agreement”). The Revolving Credit Agreement includes a $15.0 million sub-facility for the issuance of letters of credit, of which the Company is utilizing approximately $6.2 million. Amounts available under the Revolving Credit Agreement are for the working capital needs and other general corporate purposes of the Company. The Company incurred and capitalized approximately $1.1 million of debt issuance costs related to the Revolving Credit Agreement. Outstanding borrowings under the Revolving Credit Agreement bear interest, with pricing based from time to time at the Company’s election at (i) the Secured Overnight Financing Rate (“SOFR”) plus 0.10% plus a spread ranging from 1.25% to 2.50% as determined by the Company’s Total Net Leverage Ratio (as defined in the Revolving Credit Agreement) or (ii) the alternative base rate (as defined in the Revolving Credit Agreement) plus a spread ranging from 0.25% to 1.50% as determined by the Company’s Total Net Leverage Ratio. The Revolving Credit Agreement also includes a commitment fee, which ranges from 0.20% to 0.25% as determined by the Company’s Total Net Leverage Ratio. The Company is permitted to voluntarily prepay borrowings under the Revolving Credit Agreement, in whole or in part, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans (as defined in the Revolving Credit Agreement) and letters of credit exceeds the total Revolving Commitments (as defined in the Revolving Credit Agreement), the Company must prepay the Revolving Loans in an amount equal to such excess. As of December 31, 2022, there are no outstanding borrowings under the Revolving Credit Agreement. The Revolving Credit Agreement contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. The Revolving Credit Agreement requires the Company to be in quarterly compliance, measured on a trailing four quarter basis, with a financial covenant. The maximum Total Net Leverage Ratio (as defined in the Revolving Credit Agreement is 3.50 to 1.00. The Company may elect to increase the maximum Total Net Leverage Ratio to 4.00 to 1.00 for a period of four consecutive quarters in connection with a Permitted Acquisition (as defined in the Revolving Credit Agreement). The Revolving Credit Agreement contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all, or substantially all, of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates. Obligations under the Revolving Credit Agreement are secured by first priority liens over substantially all of the assets of Vericel Corporation, excluding certain subsidiaries (subject to customary exclusions set forth in the Revolving Credit Agreement and the other transaction documents). |
Net (Loss) Income Per Common Sh
Net (Loss) Income Per Common Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Common Share | Net (Loss) Income Per Common Share A summary of net (loss) income per common share is presented below: Year Ended December 31, (Amounts in thousands, except per share amounts) 2022 2021 2020 Net (loss) income $ (16,709) $ (7,471) $ 2,864 Basic weighted-average common shares outstanding 47,130 46,472 45,221 Effect of dilutive stock options and restricted stock units — — 2,061 Diluted weighted-average common shares outstanding 47,130 46,472 47,282 Basic (loss) income per common share $ (0.35) $ (0.16) $ 0.06 Diluted (loss) income per common share $ (0.35) $ (0.16) $ 0.06 Anti-dilutive shares excluded from diluted net (loss) income per common share: Stock options 6,609 5,670 2,204 Restricted stock units 648 399 — |
Shareholder's Equity
Shareholder's Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Shareholder's Equity | Shareholder’s Equity At-the-Market Offering On August 27, 2021, the Company entered into a Sales Agreement with SVB Leerink LLC, as sales agent (“SVB Leerink”), pursuant to which it may offer and sell up to $200.0 million of shares of the Company’s common stock, no par value per share (“ATM Shares”). The ATM Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to an automatically effective shelf registration statement on Form S-3ASR (File No. 333-259119) filed by the Company on August 27, 2021, which expires three years from the filing date. The Company also filed a prospectus supplement relating to the offering and sale of the ATM Shares on August 27, 2021. The Company is not obligated to make any sales of ATM Shares, and SVB Leerink is not required to sell any specific number or dollar amount of the ATM Shares under the Sales Agreement. The Company capitalized certain legal, professional accounting and other third-party fees that were directly associated with in-process stock financings as deferred offering costs until such financings are consummated. As of December 31, 2022, the Company has sold no shares pursuant to the Sales Agreement. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company’s fair value measurements are classified and disclosed in one of the following three categories: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; • Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The commercial paper, corporate notes, and U.S. government agency bonds are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. There were no transfers into or out of Level 3 from December 31, 2020 to December 31, 2022. The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis: December 31, 2022 December 31, 2021 Fair value measurement category Fair value measurement category (In thousands) Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 1,262 $ 1,262 $ — $ — $ 1,258 $ 1,258 $ — $ — Commercial paper (a) 15,606 — 15,606 — 18,229 — 18,229 — Corporate notes 51,328 — 51,328 — 50,524 — 50,524 — U.S. government agency bonds (a) 27,976 — 27,976 — — — — — $ 96,172 $ 1,262 $ 94,910 $ — $ 70,011 $ 1,258 $ 68,753 $ — (a) Approximately $6.5 million of U.S. government agency bonds and $8.0 million of commercial paper had an original maturity of 90 days or less and is recorded as a cash equivalent as of December 31, 2022 and 2021, respectively. The fair values of the cash equivalents and marketable securities are based on observable market prices. The Company’s accounts receivables, accounts payable and accrued expenses are valued at cost which approximates fair value. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of (loss) income before income taxes are summarized as follows: Year Ended December 31, (In thousands) 2022 2021 2020 U.S. $ (15,912) $ (7,367) $ 2,767 Foreign (76) (104) 97 (Loss) income before income taxes $ (15,988) $ (7,471) $ 2,864 A reconciliation of income taxes computed using the U.S. federal statutory rate to the taxes reported in the consolidated statements of operations is as follows: Year Ended December 31, (In thousands) 2022 2021 2020 (Loss) income before income taxes $ (15,988) $ (7,471) $ 2,864 Federal statutory rate 21 % 21 % 21 % Taxes computed at federal statutory rate (3,357) (1,569) 601 State and local income taxes (630) (345) 200 Nondeductible stock-based compensation 1,168 (4,311) 437 Federal and state rate change 574 47 249 Research and orphan drug credits (644) (413) (8,827) Other 267 (87) 132 Change in valuation allowance 3,343 6,567 7,388 Reported income taxes $ 721 $ (111) $ 180 Deferred tax assets (liabilities) consist of the following: Year Ended December 31, (In thousands) 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 7,020 $ 11,571 Employee benefits and stock-based compensation 18,028 11,470 Research and development costs 7,530 5,059 Intangible assets 1,770 2,544 Operating lease liabilities 11,846 12,822 Inventory reserve 2,780 2,833 Tax credit carryforward 11,143 10,498 Other, net 12 13 Total deferred tax assets 60,129 56,810 Less: valuation allowance (47,290) (43,947) Total net deferred tax assets 12,839 12,863 Deferred tax liabilities: Right-of-use assets (10,891) (12,266) Property and equipment, net (1,948) (597) Total net deferred tax liabilities (12,839) (12,863) Net deferred tax assets and liabilities $ — $ — As of December 31, 2022, the Company had U.S. federal net operating loss carryforwards of $23.1 million, of which $11.2 million begin to expire in 2033 and the remainder do not expire but are subject to 80% limitation. As of December 31, 2022, the Company had state net operating loss carryforwards of $20.9 million that begin to expire in 2034. The projected annual limitation on the use of the net operating losses that existed prior to September 17, 2014 resulting from the Company’s change in control in 2014 per Section 382 of the Internal Revenue Code is $0.8 million. As a result, a significant portion of the net operating losses and tax credit carryforwards will expire prior to their utilization, regardless of the level of future profitability. As of December 31, 2022, the Company’s U.S. federal tax credit carryforwards available to offset future profits are $11.1 million. Based on the research and development and orphan drug credit tax studies performed during 2020, the Company had a sufficient basis to claim the credits and recognized a tax credit carryforward in the 2020 tax year. These credit carryforwards will expire between 2034 and 2040. In accordance with the accounting guidance for income taxes, the Company estimates whether recoverability of its deferred tax assets is “more likely than not”, based on forecasts of taxable income in the related tax jurisdictions. In this estimate, the Company uses historical results, projected future operating results based upon approved business plans, eligible carry forward periods, tax planning opportunities and other relevant considerations. Based on these factors, including historical losses incurred by the Company, a full valuation allowance for the deferred tax assets, including the deferred tax assets for the aforementioned net operating losses and credits has been provided, since they are not more likely than not to be realized. If sufficient positive evidence exists in future periods to support a release of some or all of the valuation allowance, such a release would likely have a material impact on the Company’s results of operations. The change in the valuation allowance was an increase of $3.3 million and $6.6 million for the years ended December 31, 2022 and 2021, respectively. The Company assesses uncertain tax positions in accordance with the guidance for accounting for uncertain tax positions. This pronouncement prescribes a recognition threshold and measurement methodology for recording within the consolidated financial statements uncertain tax positions taken, or expected to be taken, in the Company’s income tax returns. To the extent the uncertain tax positions do not meet the “more likely than not” threshold, the Company derecognizes such positions. To the extent the uncertain tax positions meet the “more likely than not” threshold, the Company measures and records the highest probable benefit, and establishes appropriate reserves for benefits that exceed the amount likely to be sustained upon examination. The Company currently has not recorded any uncertain tax positions and does not anticipate that unrecognized tax benefits will significantly increase or decrease within the next twelve months. The Company files U.S. federal and state income tax returns with varying statute of limitations. During the year-ended December 31, 2020, examinations by U.S. tax authorities were completed for 2017 and 2018. Due to the Company’s net operating loss carryforwards, federal income tax returns from incorporation are still subject to examination. The Company files in several state tax jurisdictions and is subject to examination in years ranging from incorporation to 2022. |
Employee Savings Plan
Employee Savings Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Savings Plan | Employee Savings Plan The Company has a 401(k) savings plan that allows participating employees to contribute a portion of their salary, subject to annual limits and minimum qualifications. The Board may, at its sole discretion, approve Company matching contributions to the plan. The Company made contributions of $1.1 million, $1.0 million and $0.8 million for the years ended December 31, 2022, 2021 and 2020, respectively. |
Nexobrid License and Supply Agr
Nexobrid License and Supply Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
NexoBrid License and Supply Agreements | NexoBrid License and Supply Agreements On May 6, 2019, the Company entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. NexoBrid is a topically-administered biological product, which was approved by the FDA on December 28, 2022 for commercial use in the U.S. NexoBrid contains proteolytic enzymes and is indicated for the removal of eschar in adults with deep partial-thickness and/or full thickness thermal burns. Pursuant to the terms of the license agreement, following the FDA approval of NexoBrid, MediWound transferred the BLA to Vericel effective February 20, 2023. Both MediWound and Vericel, under the supervision of a Central Steering Committee comprised of members of both companies will continue to guide the development of NexoBrid in North America (the “Central Steering Committee”). NexoBrid is approved in the European Union (“EU”) and other international markets and has been designated as an orphan biologic in the U.S., EU and other international markets. In May 2019, the Company paid MediWound $17.5 million in consideration for the license, which was recorded as research and development expense during 2019. Pursuant to the terms of the license agreement, the Company is also obligated to pay MediWound a $7.5 million regulatory milestone payment within thirty days of BLA approval of NexoBrid. The FDA approved the NexoBrid BLA on December 28, 2022. As of December 31, 2022, the Company recorded the $7.5 million milestone payment for the licensing rights to commercially sell NexoBrid in the U.S., as an intangible asset. The $7.5 million payment for the intangible asset occurred in February 2 023. The Company is additionally obligated to pay MediWound up to $125.0 million, which is contingent upon meeting certain sales milestones. The first sales milestone payment of $7.5 million would be triggered when annual net sales of NexoBrid or improvements to it in North America exceed $75.0 million. As of December 31, 2022, the sales milestone payments are not yet probable and therefore, not recorded as a liability. The Company also will pay MediWound tiered royalties on net sales ranging from mid-high single-digit to mid-teen percentages, subject to customary reductions. Pursuant to the terms of the Company’s supply agreement with MediWound, MediWound will manufacture NexoBrid for the Company on a unit price basis, which may be increased pursuant to the terms of the supply agreement. MediWound is obligated to supply the Company with NexoBrid for sale in North America on an exclusive basis for the first five years of the term of the supply agreement. Under the supply agreement, the Company possess the option to extend the initial term of the agreement by an additional 24 months, which it did in May 2022. After the exclusivity period or upon supply failure, the Company will be permitted to establish an alternate source of supply. Since 2020, BARDA has been procuring NexoBrid from MediWound for use as a medical countermeasure in the event of a mass casualty emergency in the U.S. involving thermal burns. That quarterly procurement of NexoBrid by BARDA under its agreement with MediWound completed during the third quarter of 2022, although BARDA holds an option to procure additional quantities of NexoBrid in the future for emergency response preparedness. As a part of BARDA’s commitment to procure NexoBrid, the Company has received a percentage of gross profit for sales directly to BARDA. If, in the future, BARDA procures NexoBrid directly from Vericel, the Company will pay a percentage of gross profits to MediWound on initial committed amounts and a royalty on any additional BARDA purchases of NexoBrid beyond the initial committed amount. As of December 31, 2022, the Company does not hold a direct contract or distribution agreement with BARDA. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Legal Proceedings From time-to-time, the Company could be a party to various legal proceedings arising in the ordinary course of business. The costs and outcome of litigation, regulatory, investigatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements. As of December 31, 2022, the Company had no material ongoing litigation in which the Company was a party or any material ongoing regulatory or other proceedings and had no knowledge of any investigations by government or regulatory authorities in which the Company is a target that could have a material adverse effect on its current business. Manufacturing and Supply Agreements Matricel — In October 2015, the Company signed a long-term supply agreement with Matricel GmbH (“Matricel”) for the ACI-Maix collagen membrane used in the manufacture of MACI. The Company and Matricel amended the agreement on March 17, 2018. Under the agreement, the Company has committed to purchase annually approximately $0.6 million per year. The Company has fulfilled this commitment for each of the years ended December 31, 2022, 2021 and 2020, respectively. The agreement is effective until March 31, 2023. Manufacture, Supply and Other Agreements — The Company has entered into various agreements relating to the manufacture of its products and the supply of certain components. If the manufacturing or supply agreements expire or are otherwise terminated, the Company may not be able to identify and obtain ancillary materials that are necessary to develop its products and such expiration and termination could have a material effect on the Company’s business. The Company’s purchase commitments consist of minimum purchase amounts of materials used in the Company’s cell manufacturing process to manufacture its marketed cell therapy products. In addition, the Company also pays for usage of offsite warehouse space. In February 2021, the terms of one of the warehouse operating agreements were extended through March 31, 2027. Future minimum purchase commitments related to the Company’s contractual obligations are as follows: Payments Due by Period Contractual Obligations (In thousands) Total 2023 2024 2025 2026 2027 More than 5 Years Purchase commitments $ 3,416 $ 3,416 $ — $ — $ — $ — $ — Warehouse operating agreement 5,788 1,776 1,819 849 886 458 — Total $ 9,204 $ 5,192 $ 1,819 $ 849 $ 886 $ 458 $ — |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The more significant estimates reflected in the Company’s consolidated financial statements include, but are not limited to, certain judgments regarding revenue recognition, inventory valuation, stock option valuation, deferred tax assets and liabilities and accrued expenses. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments reflected in these consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance of these consolidated financial statements. These estimates may change as new events occur and additional information is obtained. Actual results could materially differ from those estimates. |
Cash Equivalents | Cash Equivalents Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase and consist primarily of demand deposits, money market funds, U.S. government agency bonds and commercial paper. |
Restricted cash | Restricted Cash Amounts included in restricted cash as of December 31, 2021, represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. |
Investments | Investments Investments classified as short-term have maturities of less than one year. Investments classified as long-term are those that: (i) have a maturity of greater than one year, and (ii) the Company does not intend to liquidate within the next twelve months, Unrealized gains are included as a component of accumulated other comprehensive income in the consolidated balance sheets and consolidated statements of shareholders’ equity and a component of total comprehensive (loss) income in the consolidated statements of comprehensive (loss) income, until realized. Unrealized losses are evaluated for impairment under ASC 326 , Financial Instruments - Credit Losses |
Leases | Leases The Company determines if an arrangement is a lease at inception, in accordance with ASC Topic 842, Leases . All operating lease commitments with a lease term greater than 12 months are recognized as right-of-use assets and liabilities, on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Certain of the Company’s lease agreements include lease payments that are adjusted periodically for an index or rate. The leases are initially measured using the present value of the projected payments adjusted for the index or rate in effect at the commencement date. In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance and other expenses, which do not transfer a good or service to the Company and are generally referred to as non-lease components. Variable non-lease components are not measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. |
Inventory | Inventory Inventories are measured at the lower of cost or net realizable value. Cost is calculated based upon standard-cost which approximates costs determined on the first-in, first-out method. The Company periodically reviews its inventories for excess or obsolescence and writes down obsolete or other unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by the Company, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts written down are charged to cost of product sales. |
Accounts Receivable | Accounts Receivable Accounts receivable are initially recorded at the contractual amount owed by the customer or based on expected payments from the insurance provider, hospital or patient. Allowances for doubtful accounts are established when the facts and circumstances indicate that a receivable may not be collectible. Potential credit risk exposure has been evaluated for the Company’s accounts receivable in accordance with ASC 326 . |
Property and Equipment, net | Property and Equipment, net Property and equipment are initially measured and recognized at acquisition cost, including any directly attributable cost of preparing the asset for its intended use. After initial measurement, property and equipment are carried at cost less accumulated depreciation. Repair and maintenance costs of property and equipment are expensed as incurred. The depreciable value of property and equipment is depreciated on a straight-line basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life. The useful lives of property and equipment are as follows: • Machinery and equipment: 3 to 10 years • Furniture, fixtures and office equipment: 5 years • Computer equipment and software: 3 years • Leasehold improvements: shorter of the remaining life of the lease or 15 years The costs of assets retired or otherwise disposed of and the accumulated depreciation thereon are removed from the accounts, with any gain or loss realized upon sale or disposal credited or charged to operations. |
Intangible Assets, net | Intangible Assets, net The Company amortizes its intangible assets on a straight-line basis over their estimated economic lives, unless another amortization method is deemed to be more appropriate. In determining the useful lives of intangible assets, the Company considers the expected use of the assets and the effects of obsolescence, demand, competition, anticipated technological advances, market influence and other economic factors. Intangible assets are assessed for impairment whenever events or circumstances indicate that the carrying amount of an asset may not be recoverable. If it is determined that the carrying amount of an asset is not recoverable, an impairment loss is recorded as a permanent reduction in the amount by which the carrying amount of the asset exceeds its fair value. |
Revenue Recognition | Revenue Recognition The Company recognizes product revenue from sales to a customer (whether a distributor, or hospital) following the five step model in Accounting Standards Codification 606, Revenue Recognition (“ ASC 606”): (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation. Under this revenue standard, the Company recognizes revenue when its customer obtains control of the promised goods, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods. There are no contractual rights of returns, refunds or similar obligations related to MACI, MACI biopsy kits, Epicel or NexoBrid; however, in certain limited cases the Company will accept a product return if a surgery is canceled. Revenue is not recognized in certain canceled cases. For MACI, MACI biopsy kits, Epicel and NexoBrid, there are no variable pricing arrangements related to warranties or rebates offered to customers. The majority of orders are due within 60 to 90 days of delivery. Shipping and handling fees are included as a component of revenue. The Company recognizes any commission fees as an expense when incurred. These fees are included in selling, general, and administrative expenses. See Note 3, “Revenue” for further discussion on revenues. |
Research and Development Expense | Research and Development Expense |
Stock-Based Compensation | Stock-Based Compensation The Company’s accounting for stock-based compensation requires it to determine the fair value of common stock issued in the form of stock option awards and restricted stock units. The fair value of restricted stock units held by the employees is determined based on the fair value of the Company’s common stock on the date of the grant. Compensation expense is recorded for restricted stock units that are expected to vest over the expected vesting period. The fair value of stock options held by the employees is determined using a Black-Scholes option valuation method. Key assumptions in determining fair value include volatility, risk-free interest rate, dividend yield and expected term. The assumptions used in calculating the fair value of stock options represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and different assumptions are used, the stock-based compensation expense could be materially different in the future. In addition, the Company estimates the expected forfeiture rate and only recognizes expense for those stock options expected to vest over the service period. The estimated forfeiture rate considers the historical experience of the Company’s stock-based awards. If the actual forfeiture rate is different from the estimate, expense is adjusted accordingly. The Company records the expense for stock options and restricted stock units using a graded-vesting attribution method. |
Comprehensive (Loss) Income | Comprehensive (Loss) Income Comprehensive (loss) income is the change in shareholders’ equity during a period arising from unrealized gains or losses related to the Company’s investments. |
Income Taxes | Income Taxes Deferred tax assets are recognized for deductible temporary differences and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized based on the weight of available evidence. When evaluating the realizability of the deferred tax assets, all evidence, both positive and negative, is considered. Items considered when evaluating the need for a valuation allowance include the ability to carry back losses, future reversals of existing temporary differences, tax planning strategies, and expectations of future earnings. The Company records uncertain tax positions in the consolidated financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense. |
Net (Loss) Income Per Common Share | Net (Loss) Income Per Common ShareBasic earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period, plus the potential dilutive effect of other securities if those securities were converted or exercised. During periods in which the Company incurs net losses, both basic and diluted loss per common share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding and potentially dilutive securities are excluded from the calculation because their effect would be antidilutive. |
Financial Instruments | Financial Instruments The Company’s financial instruments include accounts receivables, accounts payable and accrued expenses for which the current carrying amounts approximate market value, based upon their short-term nature and marketable debt securities which are classified as available-for-sale and carried at fair value on a settlement date basis. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements No new accounting standards were adopted during the year ended December 31, 2022. The Company considers the applicability and impact of any recent Accounting Standards Update (“ASU”) issued by the Financial Accounting Standards Board (“FASB”). Based on the assessment, the ASU’s were determined to be either not applicable or are expected to have minimal impact on the Company's consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Risks and Uncertainties [Abstract] | |
Disaggregation of Revenue | The following table and descriptions below shows the products from which the Company generated its revenue: Year Ended December 31, Revenue by product (in thousands) 2022 2021 2020 MACI implants and kits Implants based on contracted rate sold through a specialty pharmacy (a) $ 81,388 $ 71,969 $ 57,593 Implants subject to third party reimbursement sold through a specialty pharmacy (b) 18,695 16,000 16,320 Implants sold direct based on contracted rates (c) 24,261 18,714 15,144 Implants sold direct subject to third-party reimbursement (d) 3,499 2,821 2,754 Biopsy kits - direct bill 2,090 2,194 1,908 Change in estimates related to prior periods (e) 2,034 (144) 713 Total MACI implants and kits 131,967 111,554 94,432 Epicel Direct bill (hospital) 31,731 41,521 27,536 NexoBrid revenue (f) 667 3,109 2,211 Total revenue $ 164,365 $ 156,184 $ 124,179 (a) Represents implants sold through Orsini and AllCare whereby such specialty pharmacies have a direct contract with the underlying insurance provider. The amount of reimbursement is based on contracted rates at the time of sale supported by the pharmacy’s direct contracts. (b) Represents implants sold through Orsini and AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer and are subject to third-party reimbursement. The amount of reimbursement is established based on publicly available rates, fee schedules or past payer precedents. (c) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. Also represents direct sales under a contract to specialty distributor DMS. (d) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. The payment terms are subject to third-party reimbursement from an underlying insurance provider. (e) Primarily represents changes in estimates related to implants sold through Orsini or AllCare and relate to changes to the initial expected reimbursement or collection expectation upon completion of the billing claims process. The change in estimates is a result of additional information, changes in collection expectations or actual cash collections received in the current period. (f) Represents revenue based on a percentage of gross profits for sales of NexoBrid to BARDA, pursuant to the license agreement between the Company and MediWound (see note 14). |
Selected Balance Sheet Compon_2
Selected Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of inventory | Inventory consisted of the following: December 31, (In thousands) 2022 2021 Raw materials $ 15,101 $ 12,676 Work-in-process 832 644 Finished goods 53 61 Total inventory $ 15,986 $ 13,381 |
Schedule of property and equipment, net | Property and Equipment, net consisted of the following: December 31, (In thousands) 2022 2021 Machinery and equipment $ 5,041 $ 4,522 Furniture, fixtures and office equipment 1,710 1,551 Computer equipment and software 8,224 7,769 Leasehold improvements 13,689 10,617 Construction in process 5,438 3,097 Financing right-of-use lease 37 74 Total property and equipment, gross 34,139 27,630 Less accumulated depreciation (18,302) (14,322) Total property and equipment, net $ 15,837 $ 13,308 |
Schedule of finite-lived intangible assets, future amortization expense | Future amortization expense of intangible assets as of December 31, 2022 is estimated to be as follows: (In thousands) Amount 2023 $ 625 2024 625 2025 625 2026 625 2027 625 Thereafter 4,375 Total $ 7,500 |
Schedule of accrued expenses | Accrued Expenses consisted of the following: December 31, (In thousands) 2022 2021 Bonus related compensation $ 7,132 $ 6,305 Employee related accruals 3,101 3,616 Insurance reimbursement-related liabilities 5,030 3,973 Other accrued expenses 927 151 Total accrued expenses $ 16,190 $ 14,045 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Assets and liabilities | Operating and finance lease assets and liabilities are as follows: December 31, (In thousands) Classification 2022 2021 Assets Operating Right-of-use assets $ 41,535 $ 45,720 Finance Property and equipment, net 37 73 Total leased assets $ 41,572 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,302 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,268 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 47,611 $ 50,182 |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2022 are as follows: (In thousands) Operating Leases Finance Leases Total 2023 $ 4,302 $ 41 $ 4,343 2024 6,946 — 6,946 2025 6,348 — 6,348 2026 6,530 — 6,530 2027 6,726 — 6,726 Thereafter 30,251 — 30,251 Total lease payments $ 61,103 $ 41 $ 61,144 Less: interest (13,533) — (13,533) Present value of lease liabilities (a) $ 47,570 $ 41 $ 47,611 (a) As of December 31, 2022, the Burlington Lease has not yet commenced. The Burlington Lease has future minimum lease payments of approximately $98.9 million and a tenant improvement allowance of $25.1 million with a lease term of 144 months. These undiscounted amounts are not included in this table. |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2022 are as follows: (In thousands) Operating Leases Finance Leases Total 2023 $ 4,302 $ 41 $ 4,343 2024 6,946 — 6,946 2025 6,348 — 6,348 2026 6,530 — 6,530 2027 6,726 — 6,726 Thereafter 30,251 — 30,251 Total lease payments $ 61,103 $ 41 $ 61,144 Less: interest (13,533) — (13,533) Present value of lease liabilities (a) $ 47,570 $ 41 $ 47,611 (a) As of December 31, 2022, the Burlington Lease has not yet commenced. The Burlington Lease has future minimum lease payments of approximately $98.9 million and a tenant improvement allowance of $25.1 million with a lease term of 144 months. These undiscounted amounts are not included in this table. |
Lease term and discount rate | Lease terms and discount rates are as follows: December 31, 2022 2021 Weighted-average remaining lease term (years) Operating leases 8.9 9.8 Finance leases 0.5 1.5 Weighted-average discount rate Operating leases 5.4% 5.4% Finance leases 5.0% 5.0% |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of fair value of securities, not including cash | The following tables summarize the gross unrealized gains and losses of the Company’s marketable securities as of December 31, 2022 and 2021: December 31, 2022 Gross Unrealized (In thousands) Amortized Cost Gains Losses Credit Losses Estimated Fair Value Commercial paper $ 15,707 $ — $ (101) $ — $ 15,606 Corporate notes 52,159 — (831) — 51,328 U.S. government agency bonds 21,545 — (46) — 21,499 $ 89,411 $ — $ (978) $ — $ 88,433 Classified as: Short-term investments $ 68,471 Long-term investments 19,962 $ 88,433 December 31, 2021 Gross Unrealized (In thousands) Amortized Cost Gains Losses Credit Losses Estimated Fair Value Commercial paper $ 10,243 $ — $ (12) $ — $ 10,231 Corporate notes 50,666 — (142) — 50,524 $ 60,909 $ — $ (154) $ — $ 60,755 Classified as: Short-term investments $ 35,068 Long-term investments 25,687 $ 60,755 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of non-cash stock-based compensation expense | Non-cash stock-based compensation expense (service-based stock options, restricted stock units and employee stock purchase plan) is summarized in the following table: Years Ended December 31, (in thousands) 2022 2021 2020 Cost of product sales $ 3,630 $ 3,681 $ 1,949 Research and development 5,261 4,120 1,884 Selling, general and administrative 28,292 26,521 10,010 Total non-cash stock-based compensation expense $ 37,183 $ 34,322 $ 13,843 |
Schedule of fair value assumptions | The fair value of each service-based stock option grant for the reported periods is estimated on the date of the grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Year Ended December 31, Service-Based Stock Options 2022 2021 2020 Expected dividend rate —% —% —% Expected stock price volatility 63.8 - 75.3% 71.5 - 76.7% 71.1 - 78.7% Risk-free interest rate 1.5 - 4.4% 0.53 -1.5% 0.33 -1.7% Expected life (years) 5.3 - 6.3 5.3 - 6.3 5.3 - 6.3 |
Summary of activity for service-based stock options | The following table summarizes the activity for service-based stock options for the indicated periods: Service-Based Stock Options Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2021 5,669,690 $ 22.49 7.2 $ 113,985 Granted 1,348,824 33.37 Exercised (234,707) 10.22 Expired (31,436) 36.20 Forfeited (143,224) 31.42 Outstanding at December 31, 2022 6,609,147 $ 24.89 6.8 $ 56,708 Exercisable at December 31, 2022 4,205,883 $ 18.49 5.8 $ 51,204 |
Summary of activity for restricted stock awards | The following table summarizes the activity for restricted stock units for the indicated periods: Restricted Stock Units Number of Restricted Stock Units Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 398,748 $ 36.30 Granted 422,958 33.71 Vested (135,380) 35.45 Forfeited (38,152) 34.98 Unvested at December 31, 2022 648,174 $ 34.86 |
Net (Loss) Income Per Common _2
Net (Loss) Income Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of net loss attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two class method | A summary of net (loss) income per common share is presented below: Year Ended December 31, (Amounts in thousands, except per share amounts) 2022 2021 2020 Net (loss) income $ (16,709) $ (7,471) $ 2,864 Basic weighted-average common shares outstanding 47,130 46,472 45,221 Effect of dilutive stock options and restricted stock units — — 2,061 Diluted weighted-average common shares outstanding 47,130 46,472 47,282 Basic (loss) income per common share $ (0.35) $ (0.16) $ 0.06 Diluted (loss) income per common share $ (0.35) $ (0.16) $ 0.06 Anti-dilutive shares excluded from diluted net (loss) income per common share: Stock options 6,609 5,670 2,204 Restricted stock units 648 399 — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of valuation of the Company's investments and financial instruments that are measured at fair value on a recurring basis | The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis: December 31, 2022 December 31, 2021 Fair value measurement category Fair value measurement category (In thousands) Total Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Assets: Money market funds $ 1,262 $ 1,262 $ — $ — $ 1,258 $ 1,258 $ — $ — Commercial paper (a) 15,606 — 15,606 — 18,229 — 18,229 — Corporate notes 51,328 — 51,328 — 50,524 — 50,524 — U.S. government agency bonds (a) 27,976 — 27,976 — — — — — $ 96,172 $ 1,262 $ 94,910 $ — $ 70,011 $ 1,258 $ 68,753 $ — (a) Approximately $6.5 million of U.S. government agency bonds and $8.0 million of commercial paper had an original maturity of 90 days or less and is recorded as a cash equivalent as of December 31, 2022 and 2021, respectively. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of components of (loss) income before income taxes | The components of (loss) income before income taxes are summarized as follows: Year Ended December 31, (In thousands) 2022 2021 2020 U.S. $ (15,912) $ (7,367) $ 2,767 Foreign (76) (104) 97 (Loss) income before income taxes $ (15,988) $ (7,471) $ 2,864 |
Schedule of reconciliation of income taxes computed using the federal statutory rate to the taxes reported in consolidated statements of operations | A reconciliation of income taxes computed using the U.S. federal statutory rate to the taxes reported in the consolidated statements of operations is as follows: Year Ended December 31, (In thousands) 2022 2021 2020 (Loss) income before income taxes $ (15,988) $ (7,471) $ 2,864 Federal statutory rate 21 % 21 % 21 % Taxes computed at federal statutory rate (3,357) (1,569) 601 State and local income taxes (630) (345) 200 Nondeductible stock-based compensation 1,168 (4,311) 437 Federal and state rate change 574 47 249 Research and orphan drug credits (644) (413) (8,827) Other 267 (87) 132 Change in valuation allowance 3,343 6,567 7,388 Reported income taxes $ 721 $ (111) $ 180 |
Schedule of deferred tax assets | Deferred tax assets (liabilities) consist of the following: Year Ended December 31, (In thousands) 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 7,020 $ 11,571 Employee benefits and stock-based compensation 18,028 11,470 Research and development costs 7,530 5,059 Intangible assets 1,770 2,544 Operating lease liabilities 11,846 12,822 Inventory reserve 2,780 2,833 Tax credit carryforward 11,143 10,498 Other, net 12 13 Total deferred tax assets 60,129 56,810 Less: valuation allowance (47,290) (43,947) Total net deferred tax assets 12,839 12,863 Deferred tax liabilities: Right-of-use assets (10,891) (12,266) Property and equipment, net (1,948) (597) Total net deferred tax liabilities (12,839) (12,863) Net deferred tax assets and liabilities $ — $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum purchase commitments related to contractual obligations | Future minimum purchase commitments related to the Company’s contractual obligations are as follows: Payments Due by Period Contractual Obligations (In thousands) Total 2023 2024 2025 2026 2027 More than 5 Years Purchase commitments $ 3,416 $ 3,416 $ — $ — $ — $ — $ — Warehouse operating agreement 5,788 1,776 1,819 849 886 458 — Total $ 9,204 $ 5,192 $ 1,819 $ 849 $ 886 $ 458 $ — |
Organization (Details)
Organization (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) product segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of commercial-stage products | product | 3 | ||
Number of reportable segments | segment | 1 | ||
Accumulated deficit | $ 399,995 | $ 383,286 | |
Net loss | 16,709 | 7,471 | $ (2,864) |
Cash and cash equivalents | 51,067 | $ 68,330 | $ 33,620 |
Short term investments | $ 88,400 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Furniture, fixtures and office equipment | |
Property, Plant and Equipment | |
Useful lives (in years) | 5 years |
Computer equipment and software | |
Property, Plant and Equipment | |
Useful lives (in years) | 3 years |
Leasehold improvements | |
Property, Plant and Equipment | |
Useful lives (in years) | 15 years |
Minimum | |
Property, Plant and Equipment | |
Duration of lease renewal terms | 1 year |
Minimum | Machinery and equipment | |
Property, Plant and Equipment | |
Useful lives (in years) | 3 years |
Maximum | |
Property, Plant and Equipment | |
Duration of lease renewal terms | 5 years |
Maximum | Machinery and equipment | |
Property, Plant and Equipment | |
Useful lives (in years) | 10 years |
Revenue - Narrative (Details)
Revenue - Narrative (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 USD ($) pharmacy | Dec. 31, 2021 USD ($) | |
Risks and Uncertainties [Abstract] | ||
Number of specialty pharmacies | pharmacy | 2 | |
Allowance for doubtful accounts | $ 6.1 | $ 7 |
Change in estimate of uncollectible (percent) | 0.50% | |
Change in revenue recognized due to 0.5% change in uncollectible percentage | $ 0.4 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | |||
Product sales, net | $ 163,698 | $ 153,075 | $ 121,968 |
Other revenue | 667 | 3,109 | 2,211 |
Total revenue | 164,365 | 156,184 | 124,179 |
Accounting Standards Update 2014-09 | Change in estimates related to prior periods | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 2,034 | (144) | 713 |
M A C I Implants And Kits | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 131,967 | 111,554 | 94,432 |
Through Intermediary | MACI implants and kits | Contract rate | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 81,388 | 71,969 | 57,593 |
Through Intermediary | MACI implants and kits | Time-and-materials contract | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 18,695 | 16,000 | 16,320 |
Time-and-materials contract | MACI implants and kits | Time-and-materials contract | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 3,499 | 2,821 | 2,754 |
Provider or Facility | MACI implants and kits | Contract rate | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 24,261 | 18,714 | 15,144 |
Provider or Facility | NexoBrid | |||
Disaggregation of Revenue [Line Items] | |||
Other revenue | 667 | 3,109 | 2,211 |
Directly to consumer | Biopsy kits | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 2,090 | 2,194 | 1,908 |
Directly to consumer | Epicel | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | $ 31,731 | $ 41,521 | $ 27,536 |
Revenue - Concentration of Risk
Revenue - Concentration of Risk (Details) - Customer concentration - MACI | 12 Months Ended |
Dec. 31, 2022 | |
Revenue Concentration | |
Disaggregation of Revenue [Line Items] | |
Concentration risk (as a percent) | 12% |
Accounts Receivable Concentration | |
Disaggregation of Revenue [Line Items] | |
Concentration risk (as a percent) | 10% |
Selected Balance Sheet Compon_3
Selected Balance Sheet Components - Schedule of inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory: | ||
Raw materials | $ 15,101 | $ 12,676 |
Work-in-process | 832 | 644 |
Finished goods | 53 | 61 |
Total inventory | $ 15,986 | $ 13,381 |
Selected Balance Sheet Compon_4
Selected Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment, net: | ||
Financing right-of-use lease | $ 37 | $ 74 |
Total property and equipment, gross | 34,139 | 27,630 |
Less accumulated depreciation | (18,302) | (14,322) |
Total property and equipment, net | 15,837 | 13,308 |
Machinery and equipment | ||
Property and equipment, net: | ||
Total property and equipment, gross | 5,041 | 4,522 |
Furniture, fixtures and office equipment | ||
Property and equipment, net: | ||
Total property and equipment, gross | 1,710 | 1,551 |
Computer equipment and software | ||
Property and equipment, net: | ||
Total property and equipment, gross | 8,224 | 7,769 |
Leasehold improvements | ||
Property and equipment, net: | ||
Total property and equipment, gross | 13,689 | 10,617 |
Construction in process | ||
Property and equipment, net: | ||
Total property and equipment, gross | $ 5,438 | $ 3,097 |
Selected Balance Sheet Compon_5
Selected Balance Sheet Components - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment | |||
Depreciation and amortization expense | $ 3,981,000 | $ 2,965,000 | $ 2,383,000 |
Intangible assets, net | 7,500,000 | $ 0 | |
Licensing Agreements | |||
Property, Plant and Equipment | |||
Intangible assets, net | $ 7,500,000 | ||
Finite lived intangible assets useful life | 12 years | ||
Amortization expense | $ 0 |
Selected Balance Sheet Compon_6
Selected Balance Sheet Components - Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2023 | $ 625 | |
2024 | 625 | |
2025 | 625 | |
2026 | 625 | |
2027 | 625 | |
Thereafter | 4,375 | |
Total | $ 7,500 | $ 0 |
Selected Balance Sheet Compon_7
Selected Balance Sheet Components - Schedule of accrued expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued expenses | ||
Bonus related compensation | $ 7,132 | $ 6,305 |
Employee related accruals | 3,101 | 3,616 |
Insurance reimbursement-related liabilities | 5,030 | 3,973 |
Other accrued expenses | 927 | 151 |
Total accrued expenses | $ 16,190 | $ 14,045 |
Leases - Narrative (Details)
Leases - Narrative (Details) ft² in Thousands, $ in Millions | 1 Months Ended | 12 Months Ended | |||
Jan. 28, 2022 USD ($) ft² $ / ft² renewal_option | Jan. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Lessee, Lease, Description [Line Items] | |||||
Short-term lease costs (less than) | $ 0.1 | $ 0.1 | |||
Operating lease expense | 6.9 | 7.3 | $ 6.3 | ||
Finance lease expense (less than) | 0.1 | 0.1 | 0.1 | ||
Measurement of lease liability | $ 5.3 | $ 6 | $ 5.8 | ||
25 Network Drive, Burlington, Massachusetts | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of real estate property | ft² | 126 | ||||
Lease comment, grace period | 12 months | ||||
Rent start date, term | 13 months | ||||
Term of contract | 144 months | ||||
Number of renewal options | renewal_option | 1 | ||||
Lease option to extend term | 10 years | ||||
Annual lease per square foot | $ / ft² | 57 | ||||
Annual lease base rent square subject to increase percentage | 2.50% | ||||
Tenant improvement allowance | $ 25.1 | ||||
Tenant improvement allowance per square foot | $ / ft² | 200 | ||||
Letter of credit cash deposit | $ 6 | ||||
Letter of credit cash deposit lease year three | 4.2 | ||||
Letter of credit cash deposit lease year six | $ 1.8 | ||||
25 Network Drive, Burlington, Massachusetts | Minimum | |||||
Lessee, Lease, Description [Line Items] | |||||
Monthly contractual lease payments | $ 0.6 | ||||
25 Network Drive, Burlington, Massachusetts | Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Monthly contractual lease payments | $ 0.8 |
Leases - Assets And Liabilities
Leases - Assets And Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets | ||
Operating | $ 41,535 | $ 45,720 |
Finance | 37 | 73 |
Total leased assets | 41,572 | 45,793 |
Current | ||
Operating | 4,302 | 2,950 |
Finance | 41 | 41 |
Non-current | ||
Operating | 43,268 | 47,147 |
Finance | 0 | 44 |
Present value of lease liabilities | $ 47,611 | $ 50,182 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Property and equipment, net | Property and equipment, net |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | Other current liabilities |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other long-term liabilities | Other long-term liabilities |
Leases - Maturities of Lease Li
Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2023 | $ 4,302 | |
2024 | 6,946 | |
2025 | 6,348 | |
2026 | 6,530 | |
2027 | 6,726 | |
Thereafter | 30,251 | |
Total | 61,103 | |
Less: interest | (13,533) | |
Present value of lease liabilities | 47,570 | |
Finance Leases | ||
2023 | 41 | |
2024 | 0 | |
2025 | 0 | |
2026 | 0 | |
2027 | 0 | |
Thereafter | 0 | |
Total lease payments | 41 | |
Less: interest | 0 | |
Present value of lease liabilities | 41 | |
2023 | 4,343 | |
2024 | 6,946 | |
2025 | 6,348 | |
2026 | 6,530 | |
2027 | 6,726 | |
Thereafter | 30,251 | |
Total lease payments | 61,144 | |
Less: interest | (13,533) | |
Present value of lease liabilities | 47,611 | $ 50,182 |
Future minimum lease payments | 61,103 | |
25 Network Drive, Burlington, Massachusetts | ||
Operating Leases | ||
Total | 98,900 | |
Finance Leases | ||
Future minimum lease payments | 98,900 | |
Tenant improvement allowance | $ 25,100 | |
Term of contract | 144 months |
Leases - Lease Term and Discoun
Leases - Lease Term and Discount Rate (Details) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Weighted-average remaining lease term - Operating lease term | 8 years 10 months 24 days | 9 years 9 months 18 days |
Weighted-average remaining lease term - Finance lease term | 6 months | 1 year 6 months |
Weighted-average discount rate - Operating lease discount rate | 5.40% | 5.40% |
Weighted-average discount rate - Finance lease discount rate | 5% | 5% |
Investments - Schedule of Fair
Investments - Schedule of Fair Value of Securities, Not Including Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 89,411 | $ 60,909 |
Gains | 0 | 0 |
Losses | (978) | (154) |
Credit Losses | 0 | 0 |
Estimated Fair Value | 88,433 | 60,755 |
Short-term investments | ||
Marketable Securities [Line Items] | ||
Estimated Fair Value | 68,471 | 35,068 |
Long-term investments | ||
Marketable Securities [Line Items] | ||
Estimated Fair Value | 19,962 | 25,687 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 15,707 | 10,243 |
Gains | 0 | 0 |
Losses | (101) | (12) |
Credit Losses | 0 | 0 |
Estimated Fair Value | 15,606 | 10,231 |
Corporate notes | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 52,159 | 50,666 |
Gains | 0 | 0 |
Losses | (831) | (142) |
Credit Losses | 0 | 0 |
Estimated Fair Value | 51,328 | $ 50,524 |
U.S. government agency bonds | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 21,545 | |
Gains | 0 | |
Losses | (46) | |
Credit Losses | 0 | |
Estimated Fair Value | $ 21,499 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | ||
Asset impairment charges | $ 0 | $ 0 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | 96 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2022 | |
Stock-Based Compensation | ||||
Awards available for future grant under the Plan (in shares) | 3,818,536 | 3,818,536 | ||
Expected to vest (in shares) | 6,311,629 | 6,311,629 | ||
Total unrecognized compensation cost | $ 31.6 | $ 31.6 | ||
Intrinsic value of stock options exercised | $ 5.4 | $ 39.5 | $ 10.5 | |
Stock options | ||||
Stock-Based Compensation | ||||
Expiration period | 10 years | |||
Vesting period | 4 years | |||
Weighted average grant-date fair value (in USD per share) | $ 19.83 | $ 32.96 | $ 8.86 | |
Weighted average period over which unrecognized compensation is expected to be recognized | 2 years 8 months 12 days | |||
Restricted stock units | ||||
Stock-Based Compensation | ||||
Weighted average period over which unrecognized compensation is expected to be recognized | 2 years 9 months 18 days | |||
Granted (in USD per share) | $ 33.71 | $ 52.07 | $ 11.41 | |
Unrecognized compensation cost | $ 13.2 | $ 13.2 | ||
Fair value of vested awards | $ 4.6 | $ 5.3 | ||
Restricted stock units | Awarded annually | Nonemployee directors | ||||
Stock-Based Compensation | ||||
Vesting period | 1 year | |||
Restricted stock units | Awarded upon initial appointment to the BOD | Nonemployee directors | ||||
Stock-Based Compensation | ||||
Vesting period | 3 years | |||
Employee Stock Purchase Plan | ||||
Stock-Based Compensation | ||||
Common stock available for issuance (in shares) | 1,000,000 | 1,000,000 | ||
Common stock granted since inception (in shares) | 796,849 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of non-cash stock-based compensation expense (Details) - Employee stock purchase plan and service-based stock options - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total non-cash stock-based compensation expense | $ 37,183 | $ 34,322 | $ 13,843 |
Cost of product sales | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total non-cash stock-based compensation expense | 3,630 | 3,681 | 1,949 |
Research and development | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total non-cash stock-based compensation expense | 5,261 | 4,120 | 1,884 |
Selling, general and administrative | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total non-cash stock-based compensation expense | $ 28,292 | $ 26,521 | $ 10,010 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of fair value assumptions (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation | |||
Expected dividend rate | 0% | 0% | 0% |
Expected stock price volatility, minimum | 63.80% | 71.50% | 71.10% |
Expected stock price volatility, maximum | 75.30% | 76.70% | 78.70% |
Risk-free interest rate, minimum | 1.50% | 0.53% | 0.33% |
Risk-free interest rate, maximum | 4.40% | 1.50% | 1.70% |
Minimum | |||
Stock-Based Compensation | |||
Expected life (years) | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days |
Maximum | |||
Stock-Based Compensation | |||
Expected life (years) | 6 years 3 months 18 days | 6 years 3 months 18 days | 6 years 3 months 18 days |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of activity for service-based stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Options | ||
Outstanding at the beginning of the period (in shares) | 5,669,690 | |
Granted (in shares) | 1,348,824 | |
Exercised (in shares) | (234,707) | |
Expired (in shares) | (31,436) | |
Forfeited (in shares) | (143,224) | |
Outstanding at the end of the period (in shares) | 6,609,147 | 5,669,690 |
Exercisable at the end of the period (in shares) | 4,205,883 | |
Weighted Average Exercise Price | ||
Outstanding at the beginning of the period (in USD per share) | $ 22.49 | |
Granted (in USD per share) | 33.37 | |
Exercised (in USD per share) | 10.22 | |
Expired (in USD per share) | 36.20 | |
Forfeited (in USD per share) | 31.42 | |
Outstanding at the end of the period (in USD per share) | 24.89 | $ 22.49 |
Exercisable at the end of the period (in USD per share) | $ 18.49 | |
Weighted Average Remaining Contractual Term | ||
Outstanding | 6 years 9 months 18 days | 7 years 2 months 12 days |
Exercisable at end of period | 5 years 9 months 18 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ 56,708 | $ 113,985 |
Exercisable at end of period | $ 51,204 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of restricted stock awards activity (Details) - Restricted stock units - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Restricted Stock Units | |||
Outstanding at beginning of period (in shares) | 398,748 | ||
Granted (in shares) | 422,958 | ||
Vested (in shares) | (135,380) | ||
Forfeited (in shares) | (38,152) | ||
Unvested at end of period (in shares) | 648,174 | 398,748 | |
Weighted-Average Grant Date Fair Value | |||
Unvested at beginning of period (in USD per share) | $ 36.30 | ||
Granted (in USD per share) | 33.71 | $ 52.07 | $ 11.41 |
Vested (in USD per share) | 35.45 | ||
Forfeited (in USD per share) | 34.98 | ||
Unvested at end of period (in USD per share) | $ 34.86 | $ 36.30 |
Revolving Credit Agreement (Det
Revolving Credit Agreement (Details) - Line of Credit | Jul. 29, 2022 USD ($) | Dec. 31, 2022 USD ($) |
Debt Instrument [Line Items] | ||
Issuance of letters of credit | $ 6,200,000 | |
Revolving Credit Facility | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 150,000,000 | |
Debt instrument, term | 5 years | |
Debt issuance costs, net | $ 1,100,000 | |
Outstanding borrowings | $ 0 | |
Leverage ratio | 3.50 | |
Increase option for leverage ratio | 4 | |
Revolving Credit Facility | Minimum | ||
Debt Instrument [Line Items] | ||
Line of credit facility, commitment fee (in percent) | 0.20% | |
Revolving Credit Facility | Maximum | ||
Debt Instrument [Line Items] | ||
Line of credit facility, commitment fee (in percent) | 0.25% | |
Revolving Credit Facility | SOFR | ||
Debt Instrument [Line Items] | ||
Basis spread on variable rate (in percent) | 0.10% | |
Revolving Credit Facility | SOFR | Minimum | ||
Debt Instrument [Line Items] | ||
Basis spread on variable rate (in percent) | 1.25% | |
Revolving Credit Facility | SOFR | Maximum | ||
Debt Instrument [Line Items] | ||
Basis spread on variable rate (in percent) | 2.50% | |
Revolving Credit Facility | Base Rate | Minimum | ||
Debt Instrument [Line Items] | ||
Basis spread on variable rate (in percent) | 0.25% | |
Revolving Credit Facility | Base Rate | Maximum | ||
Debt Instrument [Line Items] | ||
Basis spread on variable rate (in percent) | 1.50% | |
Letter of Credit | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 15,000,000 |
Net (Loss) Income Per Common _3
Net (Loss) Income Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Net Income (Loss) Attributable to Parent [Abstract] | |||
Net (loss) income | $ (16,709) | $ (7,471) | $ 2,864 |
Basic weighted-average common shares outstanding (in shares) | 47,130 | 46,472 | 45,221 |
Effect of dilutive stock options and restricted stock units (in shares) | 0 | 0 | 2,061 |
Diluted weighted-average common shares outstanding (in shares) | 47,130 | 46,472 | 47,282 |
Basic (loss) income per common share (in USD per share) | $ (0.35) | $ (0.16) | $ 0.06 |
Diluted (loss) income per common share (in USD per share) | $ (0.35) | $ (0.16) | $ 0.06 |
Stock options | |||
Anti-dilutive shares excluded from diluted net (loss) income per common share: | |||
Anti-dilutive shares excluded from the calculation of diluted earnings per share (in shares) | 6,609 | 5,670 | 2,204 |
Restricted stock units | |||
Anti-dilutive shares excluded from diluted net (loss) income per common share: | |||
Anti-dilutive shares excluded from the calculation of diluted earnings per share (in shares) | 648 | 399 | 0 |
Shareholder's Equity - Narrativ
Shareholder's Equity - Narrative (Details) $ in Millions | Aug. 27, 2021 USD ($) |
Shareholders' Equity | |
At the market offering, sales agreement, expiration period | 3 years |
At The Market | |
Shareholders' Equity | |
Sale of stock authorized value | $ 200 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | $ 88,433 | $ 60,755 |
Corporate notes | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 51,328 | 50,524 |
U.S. government agency bonds | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 21,499 | |
Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 96,172 | 70,011 |
Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 1,262 | 1,258 |
Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 94,910 | 68,753 |
Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 0 | 0 |
Recurring | Commercial Paper | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 15,606 | 18,229 |
Recurring | Commercial Paper | Cash and Cash Equivalents | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 8,000 | |
Recurring | Commercial Paper | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | Commercial Paper | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 15,606 | 18,229 |
Recurring | Commercial Paper | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | Corporate notes | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 51,328 | 50,524 |
Recurring | Corporate notes | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | Corporate notes | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 51,328 | 50,524 |
Recurring | Corporate notes | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | U.S. government agency bonds | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 27,976 | 0 |
Recurring | U.S. government agency bonds | Cash and Cash Equivalents | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 6,500 | |
Recurring | U.S. government agency bonds | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | U.S. government agency bonds | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 27,976 | 0 |
Recurring | U.S. government agency bonds | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Recurring | Money market funds | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 1,262 | 1,258 |
Recurring | Money market funds | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 1,262 | 1,258 |
Recurring | Money market funds | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 0 | 0 |
Recurring | Money market funds | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | $ 0 | $ 0 |
Income Taxes - Components of In
Income Taxes - Components of Income (Loss) Before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (15,912) | $ (7,367) | $ 2,767 |
Foreign | (76) | (104) | 97 |
(Loss) income before income taxes | $ (15,988) | $ (7,471) | $ 2,864 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of income taxes computed using the federal statutory rate to the taxes reported in consolidated statements of operations | |||
(Loss) income before income taxes | $ (15,988) | $ (7,471) | $ 2,864 |
Federal statutory rate | 21% | 21% | 21% |
Taxes computed at federal statutory rate | $ (3,357) | $ (1,569) | $ 601 |
State and local income taxes | (630) | (345) | 200 |
Nondeductible stock-based compensation | 1,168 | (4,311) | 437 |
Federal and state rate change | 574 | 47 | 249 |
Research and orphan drug credits | (644) | (413) | (8,827) |
Other | 267 | (87) | 132 |
Change in valuation allowance | 3,343 | 6,567 | 7,388 |
Reported income taxes | $ 721 | $ (111) | $ 180 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 7,020 | $ 11,571 |
Employee benefits and stock-based compensation | 18,028 | 11,470 |
Research and development costs | 7,530 | 5,059 |
Intangible assets | 1,770 | 2,544 |
Operating lease liabilities | 11,846 | 12,822 |
Inventory reserve | 2,780 | 2,833 |
Tax credit carryforward | 11,143 | 10,498 |
Other, net | 12 | 13 |
Total deferred tax assets | 60,129 | 56,810 |
Less: valuation allowance | (47,290) | (43,947) |
Total net deferred tax assets | 12,839 | 12,863 |
Deferred tax liabilities: | ||
Right-of-use assets | (10,891) | (12,266) |
Property and equipment, net | (1,948) | (597) |
Total net deferred tax liabilities | (12,839) | (12,863) |
Net deferred tax assets and liabilities | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Projected annual limitation on the use of the net operating losses that existed prior to September 17, 2014 | $ 800 | |
General business tax credit carryforward | 11,143 | $ 10,498 |
Increase (decrease) in valuation allowance | 3,300 | $ 6,600 |
Federal | Internal Revenue Service | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | 23,100 | |
Net operating loss carryforwards which begin to expire in 2033 | 11,200 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforwards | $ 20,900 |
Employee Savings Plan (Details)
Employee Savings Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |||
Contributions made under 401(k) savings plan | $ 1.1 | $ 1 | $ 0.8 |
NexoBrid License and Supply A_2
NexoBrid License and Supply Agreements (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Feb. 23, 2023 | May 31, 2019 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||
Renewal term of supply agreement | 24 months | ||
MediWound Ltd | |||
Related Party Transaction [Line Items] | |||
Consideration payment for license | $ 17.5 | ||
Contingent consideration | 7.5 | ||
Milestone payments, assumed intangible assets | $ 7.5 | ||
Maximum contingent consideration | 125 | ||
Sales threshold for first milestone | $ 75 | ||
Term of supply agreement | 5 years | ||
MediWound Ltd | Subsequent event | |||
Related Party Transaction [Line Items] | |||
Payment to acquire intangible assets | $ 7.5 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Oct. 31, 2015 |
Commitments and Contingencies Disclosure [Abstract] | ||
Purchase obligation, annual commitment | $ 3,416 | $ 600 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Oct. 31, 2015 |
Purchase commitments | ||
Total | $ 3,416 | |
2023 | 3,416 | $ 600 |
2024 | 0 | |
2025 | 0 | |
2026 | 0 | |
2027 | 0 | |
More than 5 Years | 0 | |
Warehouse operating agreement | ||
Total | 5,788 | |
2023 | 1,776 | |
2024 | 1,819 | |
2025 | 849 | |
2026 | 886 | |
2027 | 458 | |
More than 5 Years | 0 | |
Contractual Obligation, Fiscal Year Maturity [Abstract] | ||
Total | 9,204 | |
2023 | 5,192 | |
2024 | 1,819 | |
2025 | 849 | |
2026 | 886 | |
2027 | 458 | |
More than 5 Years | $ 0 |