Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-35280 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 47,222,987 | |
Entity Central Index Key | 0000887359 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 65,216 | $ 68,330 |
Short-term investments | 45,724 | 35,068 |
Accounts receivable (net of allowance for doubtful accounts of $115 and $40, respectively) | 34,296 | 37,437 |
Inventory | 16,729 | 13,381 |
Other current assets | 4,410 | 4,246 |
Total current assets | 166,375 | 158,462 |
Property and equipment, net | 15,918 | 13,308 |
Restricted cash | 0 | 211 |
Right-of-use assets | 42,628 | 45,720 |
Long-term investments | 21,739 | 25,687 |
Other long-term assets | 1,357 | 317 |
Total assets | 248,017 | 243,705 |
Current liabilities: | ||
Accounts payable | 8,113 | 9,016 |
Accrued expenses | 13,948 | 14,045 |
Current portion of operating lease liabilities | 4,902 | 2,950 |
Other current liabilities | 41 | 41 |
Total current liabilities | 27,004 | 26,052 |
Operating lease liabilities | 43,176 | 47,147 |
Other long-term liabilities | 0 | 44 |
Total liabilities | 70,180 | 73,243 |
COMMITMENTS AND CONTINGENCIES | ||
Shareholders’ equity: | ||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding 47,201 and 46,880, respectively | 584,900 | 553,902 |
Accumulated other comprehensive loss | (1,146) | (154) |
Accumulated deficit | (405,917) | (383,286) |
Total shareholders’ equity | 177,837 | 170,462 |
Total liabilities and shareholders’ equity | $ 248,017 | $ 243,705 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 115 | $ 40 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 47,201,000 | 46,880,000 |
Common stock, shares outstanding (in shares) | 47,201,000 | 46,880,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenue, Product and Service [Extensible List] | Product [Member] | |||
Product sales, net | $ 38,326 | $ 33,718 | $ 111,004 | $ 106,025 |
Other revenue | 225 | 788 | 667 | 2,568 |
Total revenue | 38,551 | 34,506 | $ 111,671 | 108,593 |
Cost, Product and Service [Extensible List] | Product [Member] | |||
Cost of product sales | 13,318 | 12,408 | $ 40,132 | 36,600 |
Gross profit | 25,233 | 22,098 | 71,539 | 71,993 |
Research and development | 5,046 | 4,284 | 14,698 | 12,363 |
Selling, general and administrative | 26,975 | 22,775 | 79,984 | 71,625 |
Total operating expenses | 32,021 | 27,059 | 94,682 | 83,988 |
Loss from operations | (6,788) | (4,961) | (23,143) | (11,995) |
Other income (expense): | ||||
Interest income | 342 | 44 | 578 | 163 |
Interest expense | (105) | (1) | (143) | (3) |
Other income (expense) | (5) | (13) | 98 | 44 |
Total other income | 232 | 30 | 533 | 204 |
Loss before income taxes | (6,556) | (4,931) | (22,610) | (11,791) |
Income tax expense | 21 | 0 | 21 | 215 |
Net loss | $ (6,577) | $ (4,931) | $ (22,631) | $ (12,006) |
Net loss per common share: | ||||
Basic (in USD per share) | $ (0.14) | $ (0.11) | $ (0.48) | $ (0.26) |
Diluted (in USD per share) | $ (0.14) | $ (0.11) | $ (0.48) | $ (0.26) |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 47,182 | 46,669 | 47,096 | 46,355 |
Diluted (in shares) | 47,182 | 46,669 | 47,096 | 46,355 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (6,577) | $ (4,931) | $ (22,631) | $ (12,006) |
Other comprehensive loss: | ||||
Unrealized loss on investments | (291) | 0 | (992) | (37) |
Comprehensive loss | $ (6,868) | $ (4,931) | $ (23,623) | $ (12,043) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 45,804 | |||
Beginning balance at Dec. 31, 2020 | $ 134,260 | $ 510,061 | $ 14 | $ (375,815) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (3,289) | (3,289) | ||
Stock-based compensation expense | 7,019 | $ 7,019 | ||
Stock option exercises (in shares) | 359 | |||
Stock option exercises | 3,532 | $ 3,532 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 14 | |||
Shares issued under the Employee Stock Purchase Plan | 249 | $ 249 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 76 | |||
Restricted stock withheld for employee tax remittance (in shares) | (28) | |||
Restricted stock withheld for employee tax remittance | (1,501) | $ (1,501) | ||
Unrealized loss on investments | (61) | (61) | ||
Ending balance (in shares) at Mar. 31, 2021 | 46,225 | |||
Ending balance at Mar. 31, 2021 | 140,209 | $ 519,360 | (47) | (379,104) |
Beginning balance (in shares) at Dec. 31, 2020 | 45,804 | |||
Beginning balance at Dec. 31, 2020 | 134,260 | $ 510,061 | 14 | (375,815) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (12,006) | |||
Unrealized loss on investments | (37) | |||
Ending balance (in shares) at Sep. 30, 2021 | 46,767 | |||
Ending balance at Sep. 30, 2021 | 156,780 | $ 544,624 | (23) | (387,821) |
Beginning balance (in shares) at Mar. 31, 2021 | 46,225 | |||
Beginning balance at Mar. 31, 2021 | 140,209 | $ 519,360 | (47) | (379,104) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (3,786) | (3,786) | ||
Stock-based compensation expense | 10,866 | $ 10,866 | ||
Stock option exercises (in shares) | 330 | |||
Stock option exercises | 3,531 | $ 3,531 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 13 | |||
Shares issued under the Employee Stock Purchase Plan | 309 | $ 309 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 12 | |||
Restricted stock withheld for employee tax remittance (in shares) | (1) | |||
Restricted stock withheld for employee tax remittance | (61) | $ (61) | ||
Unrealized loss on investments | 24 | 24 | ||
Ending balance (in shares) at Jun. 30, 2021 | 46,579 | |||
Ending balance at Jun. 30, 2021 | 151,092 | $ 534,005 | (23) | (382,890) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (4,931) | (4,931) | ||
Stock-based compensation expense | 8,596 | $ 8,596 | ||
Stock option exercises (in shares) | 176 | |||
Stock option exercises | 1,676 | $ 1,676 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 9 | |||
Shares issued under the Employee Stock Purchase Plan | 404 | $ 404 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 4 | |||
Restricted stock withheld for employee tax remittance (in shares) | (1) | |||
Restricted stock withheld for employee tax remittance | (57) | $ (57) | ||
Unrealized loss on investments | 0 | |||
Ending balance (in shares) at Sep. 30, 2021 | 46,767 | |||
Ending balance at Sep. 30, 2021 | 156,780 | $ 544,624 | (23) | (387,821) |
Beginning balance (in shares) at Dec. 31, 2021 | 46,880 | |||
Beginning balance at Dec. 31, 2021 | 170,462 | $ 553,902 | (154) | (383,286) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (7,091) | (7,091) | ||
Stock-based compensation expense | 9,531 | $ 9,531 | ||
Stock option exercises (in shares) | 125 | |||
Stock option exercises | 1,155 | $ 1,155 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 9 | |||
Shares issued under the Employee Stock Purchase Plan | 310 | $ 310 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 108 | |||
Restricted stock withheld for employee tax remittance (in shares) | (41) | |||
Restricted stock withheld for employee tax remittance | (1,423) | $ (1,423) | ||
Unrealized loss on investments | (459) | (459) | ||
Ending balance (in shares) at Mar. 31, 2022 | 47,081 | |||
Ending balance at Mar. 31, 2022 | 172,485 | $ 563,475 | (613) | (390,377) |
Beginning balance (in shares) at Dec. 31, 2021 | 46,880 | |||
Beginning balance at Dec. 31, 2021 | 170,462 | $ 553,902 | (154) | (383,286) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (22,631) | |||
Unrealized loss on investments | (992) | |||
Ending balance (in shares) at Sep. 30, 2022 | 47,201 | |||
Ending balance at Sep. 30, 2022 | 177,837 | $ 584,900 | (1,146) | (405,917) |
Beginning balance (in shares) at Mar. 31, 2022 | 47,081 | |||
Beginning balance at Mar. 31, 2022 | 172,485 | $ 563,475 | (613) | (390,377) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (8,963) | (8,963) | ||
Stock-based compensation expense | 10,808 | $ 10,808 | ||
Stock option exercises (in shares) | 32 | |||
Stock option exercises | 428 | $ 428 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 10 | |||
Shares issued under the Employee Stock Purchase Plan | 318 | $ 318 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 19 | |||
Restricted stock withheld for employee tax remittance (in shares) | (1) | |||
Restricted stock withheld for employee tax remittance | (18) | $ (18) | ||
Unrealized loss on investments | (242) | (242) | ||
Ending balance (in shares) at Jun. 30, 2022 | 47,141 | |||
Ending balance at Jun. 30, 2022 | 174,816 | $ 575,011 | (855) | (399,340) |
Increase (Decrease) in Shareholders' Equity | ||||
Net loss | (6,577) | (6,577) | ||
Stock-based compensation expense | 9,104 | $ 9,104 | ||
Stock option exercises (in shares) | 41 | |||
Stock option exercises | 498 | $ 498 | ||
Shares issued under the Employee Stock Purchase Plan (in shares) | 15 | |||
Shares issued under the Employee Stock Purchase Plan | 331 | $ 331 | ||
Issuance of stock for restricted stock unit vesting (in shares) | 6 | |||
Restricted stock withheld for employee tax remittance (in shares) | (2) | |||
Restricted stock withheld for employee tax remittance | (44) | $ (44) | ||
Unrealized loss on investments | (291) | (291) | ||
Ending balance (in shares) at Sep. 30, 2022 | 47,201 | |||
Ending balance at Sep. 30, 2022 | $ 177,837 | $ 584,900 | $ (1,146) | $ (405,917) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (22,631) | $ (12,006) |
Adjustments to reconcile net loss to net cash flows from operating activities: | ||
Depreciation and amortization expense | 2,942 | 2,185 |
Stock-based compensation expense | 29,443 | 26,481 |
Amortization of premiums and discounts on marketable securities | 305 | 737 |
Amortization of debt issuance costs | 36 | 0 |
Non-cash lease cost | 3,120 | 3,420 |
Other | 21 | 17 |
Changes in operating assets and liabilities: | ||
Inventory | (3,348) | (3,703) |
Accounts receivable | 3,141 | 5,594 |
Other current assets | (164) | (793) |
Accounts payable | (37) | (672) |
Accrued expenses | (97) | (361) |
Operating lease liabilities | (2,019) | (2,410) |
Net cash provided by operating activities | 10,712 | 18,489 |
Investing activities: | ||
Purchases of investments | (43,950) | (49,375) |
Sales and maturities of investments | 35,944 | 50,913 |
Expenditures for property and equipment | (6,471) | (6,924) |
Net cash used in investing activities | (14,477) | (5,386) |
Financing activities: | ||
Net proceeds from common stock issuance | 3,040 | 9,701 |
Debt issuance costs | (1,076) | 0 |
Payments on employee’s behalf for taxes related to vesting of restricted stock unit awards | (1,485) | (1,619) |
Other | (39) | (252) |
Net cash provided by financing activities | 440 | 7,830 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (3,325) | 20,933 |
Cash, cash equivalents, and restricted cash at beginning of period | 68,541 | 33,831 |
Cash, cash equivalents, and restricted cash at end of period | 65,216 | 54,764 |
Supplemental disclosure of cash flow information: | ||
Right-of-use asset and lease liability recognized | 137 | 45 |
Additions to property and equipment included in accounts payable | 482 | 85 |
Restricted stock held for employee tax remittance included in accounts payable | 0 | 57 |
Reconciliation of amounts within the condensed consolidated balance sheets: | ||
Cash and cash equivalents | 65,216 | 54,553 |
Restricted cash | 0 | 211 |
Total cash, cash equivalents, and restricted cash at end of period | $ 65,216 | $ 54,764 |
Organization
Organization | 9 Months Ended |
Sep. 30, 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 two cell therapy products in the U.S., MACI ® (autologous cultured chondrocytes on porcine collagen membrane) and Epicel ® (cultured epidermal autografts). MACI 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 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”) for North American rights to NexoBrid ® , a registration-stage biological orphan product designed for the debridement of severe 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 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 U.S. Food and Drug Administration (“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, there has been significant volatility in our 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 our ability to access customers. At the outset of the pandemic, the Company put in place a comprehensive workplace protection plan, which instituted protective measures in response to the spread of the COVID-19 virus. Vericel’s workplace protection plan has closely followed guidance issued by the Centers for Disease Control and Prevention (“CDC”) and has complied with applicable federal and state law. To date, Vericel has been successful in sustaining its operations and providing MACI and Epicel to patients in need. The Company continues to review its policies and procedures regularly, including its workplace protection plan, as the pandemic evolves and the Company may take additional actions to the extent required. The Company continues to manufacture MACI and Epicel and is maintaining a significant safety stock of all key raw materials. Vericel does not expect that current global supply chain interruptions will impact its ongoing manufacturing operations. 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 the Company’s 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. The Company believes that a resurgence of COVID-19 because of emerging variants or other factors could result in additional disruptions that could impact our business and operations in the future, including intermittent restrictions on the ability of the Company’s personnel to travel and access customers for selling, marketing, training and 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 the Company’s capacity to manufacture, sell and support the use of our 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 unaudited condensed consolidated financial statements. Liquidity The accompanying condensed 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 September 30, 2022, the Company had an accumulated deficit of $405.9 million and had a net loss of $22.6 million during the nine months ended September 30, 2022. The Company had cash and cash equivalents of $65.2 million and investments of $67.5 million as of September 30, 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 condensed consolidated financial statements. The effects of the COVID-19 pandemic continue to evolve, however. 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, 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 impact of COVID-19 on the global economy and financial markets. The terms of any additional financing may adversely affect the holdings or the rights of the Company’s shareholders. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying c ondensed consolidated financial statements of Vericel are unaudited and have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates, judgments, and assumptions that may affect the reported amounts of assets, liabilities, equity, revenue and expenses. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations. The financial statements reflect, in the opinion of management, all adjustments (consisting only of normal, recurring adjustments) necessary to state fairly the financial position and results of operations as of and for the periods indicated. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenue and expenses. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning the COVID-19 pandemic and the actions taken to continue to contain or treat COVID-19, as well as the economic impact on its customers. The Company has made estimates of the impact of the COVID-19 pandemic within these financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates. As of September 30, 2022, the Company has not recorded impairments to investments, inventory, other current assets or long-lived assets as a result of the COVID-19 pandemic. The condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements at that date, but does not include all the information and notes required by U.S. GAAP for complete financial statements. These c ondensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on February 24, 2022 (“Annual Report”). Recent Accounting Pronouncements No new accounting standards were adopted during the nine months ended September 30, 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 condensed consolidated financial statements. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Risks and Uncertainties [Abstract] | |
Revenue | Revenue Revenue Recognition and Net Product Sales 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 which 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, Financial Instruments - Credit Losses . The Company assesses risk and determines a loss percentage by pooling account receivables 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 September 30, 2022. The total allowance for uncollectible consideration as of September 30, 2022 and December 31, 2021 was $6.3 million and $7.0 million, respectively. Changes to the estimate of the amount of consideration that will not be collected could have a material impact on the revenue recognized. A 50 basis points change to the estimated uncollectible percentage could result in an approximately $0.3 million decrease or increase in the revenue recognized for the nine months ended September 30, 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 medial 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 September 30, 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 recognizes 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. Revenue by Product and Customer The following table and descriptions below show the products from which the Company generated its revenue: Three Months Ended September 30, Nine Months Ended September 30, Revenue by product (in thousands) 2022 2021 2022 2021 MACI implants and kits Implants based on contracted rates sold through a specialty pharmacy (a) $ 19,377 $ 15,149 $ 50,718 $ 46,547 Implants subject to third-party reimbursement sold through a specialty pharmacy (b) 4,207 3,463 12,015 11,357 Implants sold direct based on contracted rates (c) 6,457 3,895 17,846 12,876 Implants sold direct subject to third-party reimbursement (d) 898 644 2,331 1,901 Biopsy kits - direct bill 498 577 1,565 1,647 Change in estimates related to prior periods (e) (428) 153 1,142 (125) Total MACI implants and kits 31,009 23,881 85,617 74,203 Epicel Direct bill (hospital) 7,317 9,837 25,387 31,822 NexoBrid revenue (f) 225 788 667 2,568 Total revenue $ 38,551 $ 34,506 $ 111,671 $ 108,593 (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 or AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer. 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 11). Concentration of Credit Risk For the three and nine months ended September 30, 2022, there were no customers with a total revenue concentration greater than 10%. For the three and nine months ended September 30, 2021, the Company’s total revenue concentration from an Epicel customer was 9% and 11%, respectively. For the Company’s total accounts receivable balances, there were no customers as of September 30, 2022 or December 31, 2021, with a concentration greater than 10%. |
Selected Balance Sheet Componen
Selected Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Selected Balance Sheet Components | Selected Balance Sheet Components Inventory Inventory as of September 30, 2022 and December 31, 2021: (In thousands) September 30, 2022 December 31, 2021 Raw materials $ 15,797 $ 12,676 Work-in-process 883 644 Finished goods 49 61 Total inventory $ 16,729 $ 13,381 Property and Equipment Property and Equipment, net as of September 30, 2022 and December 31, 2021: (In thousands) September 30, 2022 December 31, 2021 Machinery and equipment $ 4,697 $ 4,522 Furniture, fixtures and office equipment 1,710 1,551 Computer equipment and software 8,112 7,769 Leasehold improvements 13,674 10,617 Construction in process 4,943 3,097 Financing right-of-use lease 46 74 Total property and equipment, gross 33,182 27,630 Less accumulated depreciation (17,264) (14,322) Total property and equipment, net $ 15,918 $ 13,308 Depreciation expense for the three and nine months ended September 30, 2022 was $1.0 million and $2.9 million, respectively, and $0.7 million and $2.2 million, respectively, for the same periods in 2021. Accrued Expenses Accrued Expenses as of September 30, 2022 and December 31, 2021 are as follows: (In thousands) September 30, 2022 December 31, 2021 Bonus related compensation $ 5,472 $ 6,305 Employee related accruals 2,897 3,616 Insurance reimbursement-related liabilities 5,417 3,973 Other accrued expenses 162 151 Total accrued expenses $ 13,948 $ 14,045 |
Leases
Leases | 9 Months Ended |
Sep. 30, 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, vehicles and computer 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 condensed 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 three and nine months ended September 30, 2022 and 2021, lease expense of less than $0.1 million was recorded related to short-term leases. For the three and nine months ended September 30, 2022 , the Company recognized $1.7 million and $5.2 million, respectively, of operating lease expense and $1.8 million and $5.5 million, respectively, for the same periods in 2021 . For the three and nine months ended September 30, 2022 and 2021, the Company recognized less than $0.1 million of financing lease expense. Operating and finance lease assets and liabilities are as follows: (In thousands) Classification September 30, 2022 December 31, 2021 Assets Operating Right-of-use assets $ 42,628 $ 45,720 Finance Property and equipment, net 46 73 Total leased assets $ 42,674 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,902 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,176 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 48,119 $ 50,182 |
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, vehicles and computer 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 condensed 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 three and nine months ended September 30, 2022 and 2021, lease expense of less than $0.1 million was recorded related to short-term leases. For the three and nine months ended September 30, 2022 , the Company recognized $1.7 million and $5.2 million, respectively, of operating lease expense and $1.8 million and $5.5 million, respectively, for the same periods in 2021 . For the three and nine months ended September 30, 2022 and 2021, the Company recognized less than $0.1 million of financing lease expense. Operating and finance lease assets and liabilities are as follows: (In thousands) Classification September 30, 2022 December 31, 2021 Assets Operating Right-of-use assets $ 42,628 $ 45,720 Finance Property and equipment, net 46 73 Total leased assets $ 42,674 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,902 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,176 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 48,119 $ 50,182 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 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. 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: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Cost of product sales $ 840 $ 1,114 $ 2,992 $ 3,313 Research and development 1,273 1,126 4,143 3,222 Selling, general and administrative 6,991 6,356 22,308 19,946 Total non-cash stock-based compensation expense $ 9,104 $ 8,596 $ 29,443 $ 26,481 Service-Based Stock Options During the three and nine months ended September 30, 2022, the Company granted service-based options to purchase common stock of 42,890 and 1,206,539, respectively, and 189,882 and 1,663,954, respectively, for the same periods in 2021. The weighted-average grant-date fair value of service-based options granted during the three and nine months ended September 30, 2022 was $15.58 and $20.55 per option, respectively, and $35.65 and $33.03, respectively, for the same periods in 2021. Restricted Stock Units |
Investments
Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [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 condensed 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 September 30, 2022 and December 31, 2021: September 30, 2022 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Credit Losses Commercial paper $ 14,736 $ — $ (95) $ — $ 14,641 Corporate notes 50,893 — (1,048) — 49,845 U.S. government agency bonds 2,979 — (3) — $ 2,977 $ 68,608 $ — $ (1,146) $ — $ 67,463 Classified as: Short-term investments $ 45,724 Long-term investments 21,739 $ 67,463 December 31, 2021 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Credit Losses 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 As of September 30, 2022 and December 31, 2021 , all marketable securities held by the Company had remaining contractual maturities of three years or less. There have been no impairments of the Company’s assets measured and carried at fair value during the three and nine months ended September 30, 2022 and 2021. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 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, 2021 to September 30, 2022. The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis: September 30, 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 $ 21,676 $ 21,676 $ — $ — $ 1,258 $ 1,258 $ — $ — Commercial paper (a) 20,931 — 20,931 — 18,229 — 18,229 — Corporate notes 49,845 — 49,845 — 50,524 — 50,524 — U.S. government agency bonds 2,977 — 2,977 — — — — — $ 95,429 $ 21,676 $ 73,753 $ — $ 70,011 $ 1,258 $ 68,753 $ — (a) Approximately $6.3 million and $8.0 million of commercial paper had an original maturity of 90 days or less and was recorded as a cash equivalent as of September 30, 2022 and December 31, 2021. |
Revolving Credit Agreement
Revolving Credit Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Revolving Credit Agreement | Revolving Credit Agreement On 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 September 30, 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 Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss Per Common Share A summary of net loss per common share is presented below: Three Months Ended September 30, Nine Months Ended September 30, (Amounts in thousands, except per share amounts) 2022 2021 2022 2021 Net loss $ (6,577) $ (4,931) $ (22,631) $ (12,006) Basic weighted-average common shares outstanding 47,182 46,669 47,096 46,355 Effect of dilutive stock options and restricted stock units — — — — Diluted weighted-average common shares outstanding 47,182 46,669 47,096 46,355 Basic loss per common share $ (0.14) $ (0.11) $ (0.48) $ (0.26) Diluted loss per common share $ (0.14) $ (0.11) $ (0.48) $ (0.26) Anti-dilutive shares excluded from diluted net loss per common share: Stock options 6,536 5,852 6,536 5,852 Restricted stock units 633 412 633 412 |
NexoBrid License and Supply Agr
NexoBrid License and Supply Agreements | 9 Months Ended |
Sep. 30, 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 and any improvements to NexoBrid in North America. NexoBrid is a topically-administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns. On June 29, 2021, the Company announced that MediWound had received a complete response letter (“CRL”) from the U.S. Food & Drug Administration (“FDA”) with respect to a biologics license application (“BLA”), which MediWound had previously submitted to the FDA seeking marketing approval for the product in the U.S. As part of the CRL, the FDA communicated to MediWound that it had completed its review of the BLA, as amended, and had determined that it could not approve the BLA in its then form. The Company has continued to work with MediWound, BARDA and the FDA to address the issues identified in the CRL. On July 1, 2022, the Company and MediWound submitted a BLA resubmission to the FDA to address and respond to the issues identified by the FDA in the CRL. Subsequently, the FDA informed the Company that it has accepted the resubmission for review and has established a Prescription Drug User Fee Act (“PDUFA”) date for completing that review of January 1, 2023. Pursuant to the terms of the license agreement, if the BLA is approved, MediWound will transfer the BLA to Vericel and Vericel will market NexoBrid in the U.S. 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. The Company is also obligated to pay MediWound $7.5 million, which is contingent upon U.S. regulatory approval of the BLA for NexoBrid and up to $125.0 million, which is contingent upon meeting certain sales milestones. The first sales milestone 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 September 30, 2022, the 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. 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 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies 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 condensed consolidated financial statements. As of September 30, 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. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements No new accounting standards were adopted during the nine months ended September 30, 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 condensed consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Risks and Uncertainties [Abstract] | |
Disaggregation of revenue | The following table and descriptions below show the products from which the Company generated its revenue: Three Months Ended September 30, Nine Months Ended September 30, Revenue by product (in thousands) 2022 2021 2022 2021 MACI implants and kits Implants based on contracted rates sold through a specialty pharmacy (a) $ 19,377 $ 15,149 $ 50,718 $ 46,547 Implants subject to third-party reimbursement sold through a specialty pharmacy (b) 4,207 3,463 12,015 11,357 Implants sold direct based on contracted rates (c) 6,457 3,895 17,846 12,876 Implants sold direct subject to third-party reimbursement (d) 898 644 2,331 1,901 Biopsy kits - direct bill 498 577 1,565 1,647 Change in estimates related to prior periods (e) (428) 153 1,142 (125) Total MACI implants and kits 31,009 23,881 85,617 74,203 Epicel Direct bill (hospital) 7,317 9,837 25,387 31,822 NexoBrid revenue (f) 225 788 667 2,568 Total revenue $ 38,551 $ 34,506 $ 111,671 $ 108,593 (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 or AllCare whereby such specialty pharmacy does not have a direct contract with the underlying payer. 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 11). |
Selected Balance Sheet Compon_2
Selected Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of inventory | Inventory as of September 30, 2022 and December 31, 2021: (In thousands) September 30, 2022 December 31, 2021 Raw materials $ 15,797 $ 12,676 Work-in-process 883 644 Finished goods 49 61 Total inventory $ 16,729 $ 13,381 |
Schedule of property and equipment, net | Property and Equipment, net as of September 30, 2022 and December 31, 2021: (In thousands) September 30, 2022 December 31, 2021 Machinery and equipment $ 4,697 $ 4,522 Furniture, fixtures and office equipment 1,710 1,551 Computer equipment and software 8,112 7,769 Leasehold improvements 13,674 10,617 Construction in process 4,943 3,097 Financing right-of-use lease 46 74 Total property and equipment, gross 33,182 27,630 Less accumulated depreciation (17,264) (14,322) Total property and equipment, net $ 15,918 $ 13,308 |
Schedule of accrued expenses | Accrued Expenses as of September 30, 2022 and December 31, 2021 are as follows: (In thousands) September 30, 2022 December 31, 2021 Bonus related compensation $ 5,472 $ 6,305 Employee related accruals 2,897 3,616 Insurance reimbursement-related liabilities 5,417 3,973 Other accrued expenses 162 151 Total accrued expenses $ 13,948 $ 14,045 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Assets and Liabilities | Operating and finance lease assets and liabilities are as follows: (In thousands) Classification September 30, 2022 December 31, 2021 Assets Operating Right-of-use assets $ 42,628 $ 45,720 Finance Property and equipment, net 46 73 Total leased assets $ 42,674 $ 45,793 Liabilities Current Operating Current portion of operating lease liabilities $ 4,902 $ 2,950 Finance Other current liabilities 41 41 Non-current Operating Operating lease liabilities 43,176 47,147 Finance Other long-term liabilities — 44 Total leased liabilities $ 48,119 $ 50,182 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Cost of product sales $ 840 $ 1,114 $ 2,992 $ 3,313 Research and development 1,273 1,126 4,143 3,222 Selling, general and administrative 6,991 6,356 22,308 19,946 Total non-cash stock-based compensation expense $ 9,104 $ 8,596 $ 29,443 $ 26,481 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [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 September 30, 2022 and December 31, 2021: September 30, 2022 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Credit Losses Commercial paper $ 14,736 $ — $ (95) $ — $ 14,641 Corporate notes 50,893 — (1,048) — 49,845 U.S. government agency bonds 2,979 — (3) — $ 2,977 $ 68,608 $ — $ (1,146) $ — $ 67,463 Classified as: Short-term investments $ 45,724 Long-term investments 21,739 $ 67,463 December 31, 2021 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Credit Losses 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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: September 30, 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 $ 21,676 $ 21,676 $ — $ — $ 1,258 $ 1,258 $ — $ — Commercial paper (a) 20,931 — 20,931 — 18,229 — 18,229 — Corporate notes 49,845 — 49,845 — 50,524 — 50,524 — U.S. government agency bonds 2,977 — 2,977 — — — — — $ 95,429 $ 21,676 $ 73,753 $ — $ 70,011 $ 1,258 $ 68,753 $ — (a) Approximately $6.3 million and $8.0 million of commercial paper had an original maturity of 90 days or less and was recorded as a cash equivalent as of September 30, 2022 and December 31, 2021. |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of net loss per common share | A summary of net loss per common share is presented below: Three Months Ended September 30, Nine Months Ended September 30, (Amounts in thousands, except per share amounts) 2022 2021 2022 2021 Net loss $ (6,577) $ (4,931) $ (22,631) $ (12,006) Basic weighted-average common shares outstanding 47,182 46,669 47,096 46,355 Effect of dilutive stock options and restricted stock units — — — — Diluted weighted-average common shares outstanding 47,182 46,669 47,096 46,355 Basic loss per common share $ (0.14) $ (0.11) $ (0.48) $ (0.26) Diluted loss per common share $ (0.14) $ (0.11) $ (0.48) $ (0.26) Anti-dilutive shares excluded from diluted net loss per common share: Stock options 6,536 5,852 6,536 5,852 Restricted stock units 633 412 633 412 |
Organization (Details)
Organization (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2022 USD ($) product | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) segment product | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||
Number of therapy products | product | 2 | 2 | |||||||
Number of reportable segments | segment | 1 | ||||||||
Accumulated deficit | $ 405,917 | $ 405,917 | $ 383,286 | ||||||
Net loss | 6,577 | $ 8,963 | $ 7,091 | $ 4,931 | $ 3,786 | $ 3,289 | 22,631 | $ 12,006 | |
Cash and cash equivalents | 65,216 | $ 54,553 | 65,216 | $ 54,553 | $ 68,330 | ||||
Short term investments | $ 67,500 | $ 67,500 |
Revenue - Narrative (Details)
Revenue - Narrative (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) pharmacy | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) pharmacy | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Disaggregation of Revenue [Line Items] | |||||
Number of specialty pharmacies | pharmacy | 2 | 2 | |||
Allowance for doubtful accounts | $ 6,300 | $ 6,300 | $ 7,000 | ||
Change in estimate of uncollectible (percent) | 0.50% | ||||
Change in revenue recognized due to 0.5% change in uncollectible percentage | $ 300 | ||||
Product sales, net | 38,326 | $ 33,718 | 111,004 | $ 106,025 | |
MACI implants and kits | Time-and-materials contract | Time-and-materials contract | |||||
Disaggregation of Revenue [Line Items] | |||||
Product sales, net | $ 898 | $ 644 | $ 2,331 | $ 1,901 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | $ 38,326 | $ 33,718 | $ 111,004 | $ 106,025 |
Other revenue | 225 | 788 | 667 | 2,568 |
Total revenue | 38,551 | 34,506 | 111,671 | 108,593 |
Accounting Standards Update 2014-09 | Change in estimates related to prior periods | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | (428) | 153 | 1,142 | (125) |
MACI implants Aad kits | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 31,009 | 23,881 | 85,617 | 74,203 |
Through Intermediary | MACI implants and kits | Contract rate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 19,377 | 15,149 | 50,718 | 46,547 |
Through Intermediary | MACI implants and kits | Time-and-materials contract | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 4,207 | 3,463 | 12,015 | 11,357 |
Time-and-materials contract | MACI implants and kits | Time-and-materials contract | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 898 | 644 | 2,331 | 1,901 |
Provider or Facility | MACI implants and kits | Contract rate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 6,457 | 3,895 | 17,846 | 12,876 |
Provider or Facility | NexoBid revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Other revenue | 225 | 788 | 667 | 2,568 |
Directly to consumer | Biopsy kits | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 498 | 577 | 1,565 | 1,647 |
Directly to consumer | Epicel | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | $ 7,317 | $ 9,837 | $ 25,387 | $ 31,822 |
Revenue - Schedules of concentr
Revenue - Schedules of concentration of risk (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Revenue Concentration | Customer concentration | Epicel | ||
Product Information [Line Items] | ||
Concentration risk (as a percent) | 9% | 11% |
Selected Balance Sheet Compon_3
Selected Balance Sheet Components - Schedule of inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory: | ||
Raw materials | $ 15,797 | $ 12,676 |
Work-in-process | 883 | 644 |
Finished goods | 49 | 61 |
Total inventory | $ 16,729 | $ 13,381 |
Selected Balance Sheet Compon_4
Selected Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property and equipment, net: | ||
Financing right-of-use lease | $ 46 | $ 74 |
Total property and equipment, gross | 33,182 | 27,630 |
Less accumulated depreciation | (17,264) | (14,322) |
Total property and equipment, net | 15,918 | 13,308 |
Machinery and equipment | ||
Property and equipment, net: | ||
Total property and equipment, gross | 4,697 | 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 | 8,112 | 7,769 |
Leasehold improvements | ||
Property and equipment, net: | ||
Total property and equipment, gross | 13,674 | 10,617 |
Construction in process | ||
Property and equipment, net: | ||
Total property and equipment, gross | $ 4,943 | $ 3,097 |
Selected Balance Sheet Compon_5
Selected Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation and amortization expense | $ 1,000 | $ 700 | $ 2,942 | $ 2,185 |
Selected Balance Sheet Compon_6
Selected Balance Sheet Components - Schedule of accrued expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued expenses | ||
Bonus related compensation | $ 5,472 | $ 6,305 |
Employee related accruals | 2,897 | 3,616 |
Insurance reimbursement-related liabilities | 5,417 | 3,973 |
Other accrued expenses | 162 | 151 |
Total accrued expenses | $ 13,948 | $ 14,045 |
Leases - Narrative (Details)
Leases - Narrative (Details) ft² in Thousands, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jan. 28, 2022 USD ($) ft² renewal_option $ / ft² | Jan. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Short-term lease costs (less than) | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | ||
Operating lease expense | 1.7 | 1.8 | 5.2 | 5.5 | ||
Finance lease expense (less than) | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | ||
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 increase limit, percentage | 2.50% | |||||
Tenant improvement allowance per square foot | $ / ft² | 200 | |||||
Tenant improvement allowance | $ 25.1 | |||||
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] | ||||||
Contractual lease payments | 0.6 | |||||
25 Network Drive, Burlington, Massachusetts | Maximum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Contractual lease payments | $ 0.8 |
Leases - Assets And Liabilities
Leases - Assets And Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets | ||
Operating | $ 42,628 | $ 45,720 |
Finance | 46 | 73 |
Total leased assets | 42,674 | 45,793 |
Current | ||
Operating | 4,902 | 2,950 |
Finance | 41 | 41 |
Non-current | ||
Operating | 43,176 | 47,147 |
Finance | 0 | 44 |
Total leased liabilities | $ 48,119 | $ 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 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - Employee stock purchase plan and service-based stock options - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | $ 9,104 | $ 8,596 | $ 29,443 | $ 26,481 |
Cost of product sales | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | 840 | 1,114 | 2,992 | 3,313 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | 1,273 | 1,126 | 4,143 | 3,222 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | $ 6,991 | $ 6,356 | $ 22,308 | $ 19,946 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock options | ||||
Stock-Based Compensation | ||||
Granted (in shares) | 42,890 | 189,882 | 1,206,539 | 1,663,954 |
Weighted average grant-date fair value (in dollars per share) | $ 15.58 | $ 35.65 | $ 20.55 | $ 33.03 |
Restricted stock units | ||||
Stock-Based Compensation | ||||
Restricted stock units granted (shares) | 16,734 | 22,310 | 399,502 | 263,364 |
Weighted-average grant date fair value (in dollars per share) | $ 27.52 | $ 54.35 | $ 34.35 | $ 52.19 |
Investments (Details)
Investments (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Marketable Securities [Line Items] | |||||
Amortized Cost | $ 68,608,000 | $ 68,608,000 | $ 60,909,000 | ||
Gains | 0 | 0 | 0 | ||
Losses | (1,146,000) | (1,146,000) | (154,000) | ||
Credit Losses | 0 | 0 | 0 | ||
Estimated Fair Value | 67,463,000 | $ 67,463,000 | $ 60,755,000 | ||
Remaining contractual maturity period | 3 years | 3 years | |||
Impairments of assets | 0 | $ 0 | $ 0 | $ 0 | |
Short-term investments | |||||
Marketable Securities [Line Items] | |||||
Estimated Fair Value | 45,724,000 | 45,724,000 | $ 35,068,000 | ||
Long-term investments | |||||
Marketable Securities [Line Items] | |||||
Estimated Fair Value | 21,739,000 | 21,739,000 | 25,687,000 | ||
Commercial paper | |||||
Marketable Securities [Line Items] | |||||
Amortized Cost | 14,736,000 | 14,736,000 | 10,243,000 | ||
Gains | 0 | 0 | 0 | ||
Losses | (95,000) | (95,000) | (12,000) | ||
Credit Losses | 0 | 0 | 0 | ||
Estimated Fair Value | 14,641,000 | 14,641,000 | 10,231,000 | ||
Corporate notes | |||||
Marketable Securities [Line Items] | |||||
Amortized Cost | 50,893,000 | 50,893,000 | 50,666,000 | ||
Gains | 0 | 0 | 0 | ||
Losses | (1,048,000) | (1,048,000) | (142,000) | ||
Credit Losses | 0 | 0 | 0 | ||
Estimated Fair Value | 49,845,000 | 49,845,000 | $ 50,524,000 | ||
U.S. government agency bonds | |||||
Marketable Securities [Line Items] | |||||
Amortized Cost | 2,979,000 | 2,979,000 | |||
Gains | 0 | 0 | |||
Losses | (3,000) | (3,000) | |||
Credit Losses | 0 | 0 | |||
Estimated Fair Value | $ 2,977,000 | $ 2,977,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | $ 67,463 | $ 60,755 |
U.S. government agency bonds | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 2,977 | |
Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 95,429 | 70,011 |
Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 21,676 | 1,258 |
Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 73,753 | 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 | 20,931 | 18,229 |
Recurring | Commercial paper | Cash and Cash Equivalents | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 6,300 | 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 | 20,931 | 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 | 49,845 | 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 | 49,845 | 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 | 2,977 | 0 |
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 | 2,977 | 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 | 21,676 | 1,258 |
Recurring | Money market funds | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 21,676 | 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 |
Revolving Credit Agreement (Det
Revolving Credit Agreement (Details) - Line of Credit | Jul. 29, 2022 USD ($) | Sep. 30, 2022 USD ($) |
Line of Credit Facility [Line Items] | ||
Issuance of letters of credit | $ 6,200,000 | |
Revolving Credit Facility | ||
Line of Credit Facility [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 | ||
Line of Credit Facility [Line Items] | ||
Line of credit facility, commitment fee (in percent) | 0.20% | |
Revolving Credit Facility | Maximum | ||
Line of Credit Facility [Line Items] | ||
Line of credit facility, commitment fee (in percent) | 0.25% | |
Revolving Credit Facility | SOFR | ||
Line of Credit Facility [Line Items] | ||
Basis spread on variable rate (in percent) | 0.10% | |
Revolving Credit Facility | SOFR | Minimum | ||
Line of Credit Facility [Line Items] | ||
Basis spread on variable rate (in percent) | 1.25% | |
Revolving Credit Facility | SOFR | Maximum | ||
Line of Credit Facility [Line Items] | ||
Basis spread on variable rate (in percent) | 2.50% | |
Revolving Credit Facility | Base Rate | Minimum | ||
Line of Credit Facility [Line Items] | ||
Basis spread on variable rate (in percent) | 0.25% | |
Revolving Credit Facility | Base Rate | Maximum | ||
Line of Credit Facility [Line Items] | ||
Basis spread on variable rate (in percent) | 1.50% | |
Letter of Credit | ||
Line of Credit Facility [Line Items] | ||
Maximum borrowing capacity | $ 15,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net Income (Loss) Attributable to Parent [Abstract] | ||||||||
Net loss | $ (6,577) | $ (8,963) | $ (7,091) | $ (4,931) | $ (3,786) | $ (3,289) | $ (22,631) | $ (12,006) |
Basic weighted-average common shares outstanding (in shares) | 47,182 | 46,669 | 47,096 | 46,355 | ||||
Diluted weighted-average common shares outstanding (in shares) | 47,182 | 46,669 | 47,096 | 46,355 | ||||
Basic loss per common share (in USD per share) | $ (0.14) | $ (0.11) | $ (0.48) | $ (0.26) | ||||
Diluted loss per common share (in USD per share) | $ (0.14) | $ (0.11) | $ (0.48) | $ (0.26) | ||||
Stock options | ||||||||
Anti-dilutive shares excluded from diluted net loss per common share: | ||||||||
Anti-dilutive shares excluded from diluted net loss per common share (in shares) | 6,536 | 5,852 | 6,536 | 5,852 | ||||
Restricted stock units | ||||||||
Net Income (Loss) Attributable to Parent [Abstract] | ||||||||
Effect of dilutive stock options and restricted stock units | 0 | 0 | 0 | 0 | ||||
Anti-dilutive shares excluded from diluted net loss per common share: | ||||||||
Anti-dilutive shares excluded from diluted net loss per common share (in shares) | 633 | 412 | 633 | 412 |
NexoBrid License and Supply A_2
NexoBrid License and Supply Agreements (Details) - MediWound Ltd $ in Millions | 1 Months Ended |
May 31, 2019 USD ($) | |
Related Party Transaction [Line Items] | |
Consideration payment for license | $ 17.5 |
Contingent consideration | 7.5 |
Max contingent consideration | 125 |
Sales Initial milestone | $ 75 |
Term of supply agreement | 5 years |