Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 30, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 | 45,428,794 | |
Entity Central Index Key | 0000887359 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 43,507 | $ 26,889 |
Short-term investments | 42,035 | 42,829 |
Accounts receivable (net of allowance for doubtful accounts of $187 and $306, respectively) | 26,174 | 32,168 |
Inventory | 10,080 | 6,816 |
Other current assets | 3,586 | 2,953 |
Total current assets | 125,382 | 111,655 |
Property and equipment, net | 7,115 | 7,144 |
Restricted cash | 211 | 89 |
Right-of-use leased assets | 24,796 | 25,103 |
Long-term investments | 0 | 9,247 |
Total assets | 157,504 | 153,238 |
Current liabilities: | ||
Accounts payable | 6,475 | 6,345 |
Accrued expenses | 8,695 | 7,948 |
Current portion of operating lease liabilities | 6,102 | 5,461 |
Other liabilities | 41 | 41 |
Total current liabilities | 21,313 | 19,795 |
Operating lease liabilities | 21,487 | 22,242 |
Other long-term liabilities | 74 | 110 |
Total liabilities | 42,874 | 42,147 |
COMMITMENTS AND CONTINGENCIES | ||
Shareholders’ equity: | ||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 45,315 and 44,864, respectively | 502,587 | 489,749 |
Other comprehensive gain | 78 | 21 |
Accumulated deficit | (388,035) | (378,679) |
Total shareholders’ equity | 114,630 | 111,091 |
Total liabilities and shareholders’ equity | 157,504 | 153,238 |
Allowance for doubtful accounts | $ 187 | $ 306 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 45,315,000 | 44,864,000 |
Common stock, shares outstanding (in shares) | 45,315,000 | 44,864,000 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 187 | $ 306 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 45,315,000 | 44,864,000 |
Common stock, shares outstanding (in shares) | 45,315,000 | 44,864,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Product sales, net | $ 31,020 | $ 30,499 | $ 77,712 | $ 78,460 |
Other revenue | 1,238 | 0 | 1,238 | 0 |
Total revenue | 32,258 | 30,499 | 78,950 | 78,460 |
Cost of product sales | 9,787 | 9,324 | 28,369 | 26,986 |
Gross profit | 22,471 | 21,175 | 50,581 | 51,474 |
Research and development | 2,913 | 3,096 | 9,902 | 27,174 |
Selling, general and administrative | 16,041 | 14,982 | 50,596 | 44,761 |
Total operating expenses | 18,954 | 18,078 | 60,498 | 71,935 |
Income (loss) from operations | 3,517 | 3,097 | (9,917) | (20,461) |
Other income (expense): | ||||
Interest income | 121 | 385 | 574 | 1,293 |
Other income (expense) | (2) | (2) | (5) | (6) |
Interest expense | (18) | (10) | (8) | 8 |
Total other income | 101 | 373 | 561 | 1,295 |
Net income (loss) | $ 3,618 | $ 3,470 | $ (9,356) | $ (19,166) |
Net (loss) income per share (Basic) (in USD per share) | $ 0.08 | $ 0.08 | $ (0.21) | $ (0.44) |
Weighted average number of common shares outstanding (Basic) (in shares) | 45,272 | 44,251 | 45,112 | 43,979 |
Net (loss) income per share (Diluted) (in USD per share) | $ 0.08 | $ 0.07 | $ (0.21) | $ (0.44) |
Weighted average number of common shares outstanding (Diluted) (in shares) | 47,314 | 46,667 | 45,112 | 43,979 |
Revenue, Product and Service [Extensible List] | us-gaap:ProductMember | |||
Cost, Product and Service [Extensible List] | us-gaap:ProductMember |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 3,618 | $ 3,470 | $ (9,356) | $ (19,166) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on investments | (68) | (9) | 57 | 29 |
Comprehensive income (loss) | $ 3,550 | $ 3,461 | $ (9,299) | $ (19,137) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Warrants | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 43,578 | ||||
Beginning balance at Dec. 31, 2018 | $ 102,231 | $ 471,180 | $ 104 | $ (39) | $ (369,014) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (2,844) | (2,844) | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 2,628 | $ 2,628 | |||
Stock option exercises (in shares) | 228 | ||||
Stock option exercises | 780 | $ 780 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 19 | ||||
Shares issued under the Employee Stock Purchase Plan | 218 | $ 218 | |||
Unrealized gain (loss) on investments | 42 | 42 | |||
Ending balance (in shares) at Mar. 31, 2019 | 43,825 | ||||
Ending balance at Mar. 31, 2019 | 103,055 | $ 474,806 | 104 | 3 | (371,858) |
Beginning balance (in shares) at Dec. 31, 2018 | 43,578 | ||||
Beginning balance at Dec. 31, 2018 | 102,231 | $ 471,180 | 104 | (39) | (369,014) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (19,166) | ||||
Unrealized gain (loss) on investments | 29 | ||||
Ending balance (in shares) at Sep. 30, 2019 | 44,520 | ||||
Ending balance at Sep. 30, 2019 | 96,990 | $ 485,141 | 0 | 29 | (388,180) |
Beginning balance (in shares) at Mar. 31, 2019 | 43,825 | ||||
Beginning balance at Mar. 31, 2019 | 103,055 | $ 474,806 | 104 | 3 | (371,858) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (19,792) | (19,792) | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 4,183 | $ 4,183 | |||
Stock option exercises (in shares) | 227 | ||||
Stock option exercises | 850 | $ 850 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 14 | ||||
Shares issued under the Employee Stock Purchase Plan | 211 | $ 211 | |||
Unrealized gain (loss) on investments | 35 | 35 | |||
Ending balance (in shares) at Jun. 30, 2019 | 44,066 | ||||
Ending balance at Jun. 30, 2019 | 88,542 | $ 480,050 | 104 | 38 | (391,650) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | 3,470 | 3,470 | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 3,285 | $ 3,285 | |||
Stock option exercises (in shares) | 416 | ||||
Stock option exercises | 1,427 | $ 1,427 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 18 | ||||
Shares issued under the Employee Stock Purchase Plan | 275 | $ 275 | |||
Unrealized gain (loss) on investments | (9) | (9) | |||
Exercise of warrants resulting in the issuance of common stock (in shares) | 20 | ||||
Exercise of warrants resulting in issuance of common stock | 0 | $ 104 | (104) | ||
Ending balance (in shares) at Sep. 30, 2019 | 44,520 | ||||
Ending balance at Sep. 30, 2019 | 96,990 | $ 485,141 | 0 | 29 | (388,180) |
Beginning balance (in shares) at Dec. 31, 2019 | 44,864 | ||||
Beginning balance at Dec. 31, 2019 | 111,091 | $ 489,749 | 0 | 21 | (378,679) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (4,705) | (4,705) | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 3,768 | $ 3,768 | |||
Stock option exercises (in shares) | 57 | ||||
Stock option exercises | 196 | $ 196 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 20 | ||||
Shares issued under the Employee Stock Purchase Plan | 224 | $ 224 | |||
Issuance of stock upon restricted stock unit vesting (in shares) | 36 | ||||
Issuance of stock upon restricted stock unit vesting | 0 | ||||
Restricted stock withheld for employee tax remittance (in shares) | (14) | ||||
Restricted stock withheld for employee tax remittance | (163) | $ (163) | |||
Unrealized gain (loss) on investments | 41 | 41 | |||
Ending balance (in shares) at Mar. 31, 2020 | 44,963 | ||||
Ending balance at Mar. 31, 2020 | 110,452 | $ 493,774 | 0 | 62 | (383,384) |
Beginning balance (in shares) at Dec. 31, 2019 | 44,864 | ||||
Beginning balance at Dec. 31, 2019 | 111,091 | $ 489,749 | 0 | 21 | (378,679) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (9,356) | ||||
Unrealized gain (loss) on investments | 57 | ||||
Ending balance (in shares) at Sep. 30, 2020 | 45,315 | ||||
Ending balance at Sep. 30, 2020 | 114,630 | $ 502,587 | 0 | 78 | (388,035) |
Beginning balance (in shares) at Mar. 31, 2020 | 44,963 | ||||
Beginning balance at Mar. 31, 2020 | 110,452 | $ 493,774 | 0 | 62 | (383,384) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | (8,269) | (8,269) | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 4,376 | $ 4,376 | |||
Stock option exercises (in shares) | 188 | ||||
Stock option exercises | 696 | $ 696 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 32 | ||||
Shares issued under the Employee Stock Purchase Plan | 257 | $ 257 | |||
Issuance of stock upon restricted stock unit vesting (in shares) | 11 | ||||
Issuance of stock upon restricted stock unit vesting | 0 | ||||
Unrealized gain (loss) on investments | 84 | 84 | |||
Ending balance (in shares) at Jun. 30, 2020 | 45,194 | ||||
Ending balance at Jun. 30, 2020 | 107,596 | $ 499,103 | 0 | 146 | (391,653) |
Increase (Decrease) in Shareholders' Equity | |||||
Net income (loss) | 3,618 | 3,618 | |||
Compensation expense related to stock options and restricted stock units granted, net of forfeitures | 2,675 | $ 2,675 | |||
Stock option exercises (in shares) | 77 | ||||
Stock option exercises | 500 | $ 500 | |||
Shares issued under the Employee Stock Purchase Plan (in shares) | 44 | ||||
Shares issued under the Employee Stock Purchase Plan | 309 | $ 309 | |||
Unrealized gain (loss) on investments | (68) | (68) | |||
Ending balance (in shares) at Sep. 30, 2020 | 45,315 | ||||
Ending balance at Sep. 30, 2020 | $ 114,630 | $ 502,587 | $ 0 | $ 78 | $ (388,035) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Operating activities: | ||
Net income (loss) | $ (9,356) | $ (19,166) |
Adjustments to reconcile net loss to net cash provided by (used for) operating activities: | ||
Depreciation and amortization expense | 1,649 | 1,174 |
Stock compensation expense | 10,819 | 10,095 |
Foreign currency translation loss | 59 | 21 |
Loss on sale of fixed assets | 30 | 0 |
Amortization of premiums and discounts on marketable securities | 24 | (529) |
Amortization and interest accretion related to operating leases | 3,312 | 2,011 |
Changes in operating assets and liabilities: | ||
Inventory | (3,264) | (3,265) |
Accounts receivable | 5,994 | 3,496 |
Other current assets | (633) | (425) |
Accounts payable | (52) | (1,895) |
Accrued expenses | 747 | 30 |
Operating lease liabilities | (3,110) | (1,804) |
Other non-current assets and liabilities, net | 16 | (76) |
Net cash provided by (used for) operating activities | 6,235 | (10,333) |
Investing activities: | ||
Purchases of short-term investments | (29,049) | (46,303) |
Maturities of short-term investments | 39,123 | 73,777 |
Expenditures for property, plant and equipment | (1,556) | (2,255) |
Net cash provided by investing activities | 8,518 | 25,219 |
Financing activities: | ||
Net proceeds from common stock issuance due to stock option exercises | 2,182 | 3,762 |
Payments on employee's behalf for taxes related to vesting of restricted stock unit awards | (163) | 0 |
Other | (32) | (29) |
Net cash provided by financing activities | 1,987 | 3,733 |
Net increase in cash, cash equivalents, and restricted cash | 16,740 | 18,619 |
Cash, cash equivalents, and restricted cash at beginning of period | 26,978 | 18,286 |
Cash, cash equivalents, and restricted cash at end of period | $ 43,718 | $ 36,905 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2020 | |
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, Vericel, we, us or our), 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 United States, MACI ® and Epicel ® . Vericel obtained both products in May 2014, as part of the acquisition of certain assets and the assumption of certain liabilities of Sanofi, a French société anonyme (Sanofi). 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) for North American rights to NexoBrid ® , a registration-stage biological orphan product for 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 biopharmaceuticals for use in the treatment of specific diseases. COVID-19 The pandemic caused by the spread of a novel strain of coronavirus (COVID-19) has created significant volatility, uncertainty, and economic disruption in both domestic and international markets. The virus was first reported in China and rapidly spread globally. The World Health Organization (WHO) declared the outbreak a pandemic on March 11, 2020, and the President of the United States declared a national health emergency immediately thereafter. Following the President’s declaration, state governments, including those in Massachusetts and Michigan where the Company’s operations are located, began issuing orders requiring businesses that do not conduct essential services to temporarily close their physical workplaces to employees and customers. The status and application of those orders have varied on a state-by-state basis. Because Vericel is deemed an essential business, the Company continues to be exempt from such state orders in their current forms. Notwithstanding being an essential business, the Company’s business and operations have been adversely impacted by the effects of COVID-19. In mid-March, the American College of Surgeons and United States Surgeon General recommended that each hospital, health system, and surgeon minimize, postpone, or cancel electively scheduled surgeries. These recommendations were followed by numerous state level executive orders either restricting or partially restricting elective surgeries. Because MACI is an elective surgical procedure, as a result of these restrictions, beginning in mid-March 2020, the Company began to experience a significant increase in cancellations of scheduled MACI procedures as well as a slowdown in new MACI orders. By early April 2020, 45 states, representing over 95% of total U.S. surgical capacity had issued either mandates or recommendations and guidelines suspending elective surgical procedures. The widespread suspension of elective procedures impacted the Company’s business and operations during the first and second quarters of 2020. These restrictions began to ease in May and, by the end of September 2020, there were no state orders in place that directly impacted a surgeon's or patient's ability to move forward with a MACI surgery. Because Epicel is used almost exclusively in the emergent setting by burn centers and surgeons throughout the country, Epicel revenue and procedure volumes have been less affected by the pandemic. Although hospitals are now better prepared for a subsequent surge in COVID-19 patients, the risk remains that regional or local restrictions could again be placed on the performance of elective surgical procedures if the number of COVID-19 infections in the United States continues to rise. In March 2020, the Company put in place a comprehensive workplace protection plan, which institutes protective measures in response to COVID-19. These measures include mandatory employee training on social distancing and hygiene protocols, conducting daily health screenings of all employees, vendors and visitors entering our facilities, canceling all international business travel, limiting domestic business travel to essential purposes, requesting that employees limit non-essential personal travel, enhancing our facilities’ janitorial and sanitary procedures, making certain physical modifications and enhancements to our facilities to enable effective social distancing among employees, providing certain personal protective equipment to employees working in our offices, encouraging employees to work from home to the extent their job function enables them to do so, limiting third-party access to our facilities, encouraging the use of virtual employee meetings, modifying the manner and schedule of on-site production activities, and providing guidance to our field-based commercial teams concerning their communications and contact with customers and healthcare professionals. The Company is reviewing these measures regularly as the pandemic evolves and may take additional actions to the extent required. Going Concern 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. For the three and nine months ended September 30, 2020, the Company had net income of $3.6 million and a net loss of $9.4 million, respectively, and had an accumulated deficit of $388.0 million as of September 30, 2020. The Company had cash and cash equivalents of $43.5 million and investments of $42.0 million as of September 30, 2020. The Company expects that existing cash, cash equivalents and investments will be sufficient to support the Company’s current operations through at least 12 months from the issuance of these financial statements. However, the effects of the COVID-19 pandemic continue to evolve and may result in irrecoverable losses of customers and significantly impact long-term liquidity requiring the Company to engage in layoffs, furloughs and/or reductions in salaries. To the extent the United States experiences a resurgence in COVID-19 infections and elective surgery restrictions are reinstated on a widespread basis and significantly impact the Company’s business, the Company may need to a ccess additional capital; however, the Company may not be able to obtain 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 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, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements as of September 30, 2020 and for the three and nine months ended September 30, 2020 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, revenues 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. We base our estimates on historical experience and on various other assumptions that we believe 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 revenues and expenses. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact our 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 COVID-19 and the actions taken to continue to contain or treat COVID-19, as well as the economic impact on our customers. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates. As of September 30, 2020, the Company has not recorded impairments to investments, inventory, other current assets or long-lived assets as a result of the COVID-19 pandemic and does not expect material impairments in the future. The Company has assessed the impact of COVID-19 on accounts receivables (see note 4). These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on February 25, 2020 (Annual Report). Consolidated Statement of Cash Flows The following table presents certain supplementary cash flows information for the nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, (In thousands) 2020 2019 Supplementary Cash Flows information: Non-cash information: Right-of-use asset and lease liability recognized $ 3,140 $ 2,338 Additions to property, plant and equipment included in accounts payable 340 46 Warrants exercised for common stock — 104 Cash information: Interest paid (net of interest capitalized) $ 5 $ 6 Total cash, cash equivalents, and restricted cash of $43.7 million as of September 30, 2020, shown in the statement of cash flows is comprised of cash and cash equivalents of $43.5 million and restricted cash of $0.2 million which is included in other long-term assets on the consolidated balance sheet. As of September 30, 2019, cash and cash equivalents were $36.9 million and the Company did not have any restricted cash. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Measuring Credit Losses on Financial Instruments The FASB issued updated guidance on measuring credit losses on financial instruments. The guidance removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. Prior to the updated guidance, credit losses were recognized when it was probable that the loss had been incurred. The revised guidance removes all recognition thresholds and requires companies to recognize an allowance for credit losses for the difference between the amortized cost basis of a financial instrument and the amount of amortized cost that a company expected to collect over the instrument’s contractual life. The Accounting Standard Update (ASU) 2016-13, Financial Instruments-Credit Losses (Topic 326) , became effective for the Company January 1, 2020. See note 4 and note 8 for further discussion. Fair Value Measurement Disclosure The FASB issued updated guidance through ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The revised guidance created a more consistent disclosure framework that increased clarity and removed, modified and added certain fair value disclosures to improve the effectiveness of the Company’s disclosures in the notes of the financial statements. This guidance became effective for the Company January 1, 2020 and had no impact on its condensed consolidated financial statements. Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740, including requirements related to hybrid tax regimes, the tax basis step-up in goodwill obtained in a transaction that is not a business combination, separate financial statements of entities not subject to tax, the intra-period tax allocation exception to the incremental approach, ownership changes in investments, changes from a subsidiary to an equity method investment, interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted. The Company is currently in the process of evaluating the impact on its condensed consolidated financial statements. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2020 | |
Risks and Uncertainties [Abstract] | |
Revenue | Revenue Revenue Recognition of Net Product Sales and Other Revenue The Company recognizes product revenue from sales of MACI biopsy kits, MACI implants, Epicel grafts and other revenue following the five-step model in Accounting Standards Codification 606, Revenue Recognition, (ASC 606). Product Sales MACI Biopsy Kits MACI biopsy kits are sold directly to hospitals 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. 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 has engaged 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 (DMS) for military patients. 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 revenues 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 or a fee schedule. 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 based on current and historical information as well as reasonable and supportable forecasts. This loss percentage was applied to the accounts receivables as of September 30, 2020. The total allowance for uncollectible consideration as of September 30, 2020 and December 31, 2019 was $4.6 million and $3.9 million, respectively. The allowance includes less than $0.1 million related to COVID-19 potential impacts on accounts receivable from third-party insurers, government payers, hospitals and patients. Changes to the estimate of the amount of consideration that will not be collected could have a material impact to the revenue recognized. A 0.5% increase to the estimated uncollectible percentage could result in approximately a $0.2 million decrease in the revenue recognized for the nine months ended September 30, 2020. 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 period sales for the three and nine months ended September 30, 2020 resulted in an increase to revenue of less than $0.01 million and $0.7 million, respectively. During the same periods in 2019, the changes in estimates related to prior period sales resulted in an increase to revenue of $0.7 million and $0.4 million, respectively. The changes in estimates recorded during the three and nine months ended September 30, 2020, were primarily due to completion of the billing claims process for implants that occurred in 2019. Upon completion of the billing claims process, the Company concluded that it was probable that a significant reversal in the amount of revenue recognized would not occur. Epicel The Company sells Epicel directly to hospitals 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 revenues 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. Other Revenue NexoBrid The Company entered into exclusive license and supply agreements with MediWound, under which MediWound will manufacture and supply NexoBrid on a unit price basis, which may be increased pursuant to the terms of the agreement. The U.S. Biomedical Advanced Research and Development Authority (BARDA) has committed to procure NexoBrid. As of September 30, 2020, the Company does not hold a direct contract or distribution agreement with BARDA, or take title to the product. The Company recognizes income from sales of NexoBrid to BARDA upon delivery, at which time BARDA is in control of the product. During the three months ended September 30, 2020, the first order of NexoBrid was delivered and the Company recognized $1.2 million of revenue. See note 11 for further discussion of the NexoBrid license and supply agreements. Revenue by Product and Customer The following table and description below shows the products from which the Company generated its revenue: Three Months Ended September 30, Nine Months Ended September 30, Revenue by product (in thousands) 2020 2019 2020 2019 MACI implants and kits Implants based on contracted rate sold through a specialty pharmacy (a) $ 14,897 $ 11,779 $ 36,084 $ 34,555 Implants subject to third party reimbursement sold through a specialty pharmacy (b) 3,529 4,030 10,299 10,584 Implants sold direct based on contracted rates (c) 4,602 3,039 9,528 9,715 Implants sold direct subject to third party reimbursement (d) 782 573 1,793 1,176 Biopsy kits - direct bill 539 533 1,348 1,632 Change in estimates related to prior periods (e) 8 656 695 353 Epicel Direct bill (hospital) 6,663 9,889 17,965 20,445 Total product revenue $ 31,020 $ 30,499 $ 77,712 $ 78,460 Other revenue (f) 1,238 — 1,238 — Total net revenue $ 32,258 $ 30,499 $ 78,950 $ 78,460 (a) Represents implants sold through Orsini and AllCare in both 2020 and 2019 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 a payer or state fee schedule and/or payer history. (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 the 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 in which such specialty pharmacy does not have a direct contract with the underlying payer. The initial estimate of the amount of reimbursement is established based on a payer or state fee schedule and/or payer history. The change in estimates is a result of additional information or actual cash collections received in the current period. (f) Represents income from sales of NexoBrid to BARDA, pursuant to the license agreement between the Company and MediWound. Concentration of Credit Risk The Company's total Epicel revenue concentration from a customer for the three months ended September 30, 2019 was 10%. For the Company's total Epicel and MACI revenue and accounts receivable balances there were no other customers for the three and nine months ended September 30, 2020, and for the nine months ended September 30, 2019, with a concentration greater than 10%. |
Selected Balance Sheet Componen
Selected Balance Sheet Components | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Selected Balance Sheet Components | Selected Balance Sheet Components Inventory Inventory as of September 30, 2020 and December 31, 2019: (In thousands) September 30, 2020 December 31, 2019 Raw materials $ 9,265 $ 6,085 Work-in-process 771 541 Finished goods 44 190 Inventory $ 10,080 $ 6,816 Property and Equipment Property and Equipment, net as of September 30, 2020 and December 31, 2019: (In thousands) September 30, 2020 December 31, 2019 Machinery and equipment $ 3,683 $ 3,152 Furniture, fixtures and office equipment 810 775 Computer equipment and software 6,585 6,174 Leasehold improvements 5,436 5,256 Construction in process 1,190 859 Financing right-of-use lease 120 148 Total property and equipment, gross 17,824 16,364 Less accumulated depreciation (10,709) (9,220) Property and equipment, net $ 7,115 $ 7,144 Depreciation expense for the three and nine months ended September 30, 2020 was $0.6 million and $1.6 million, respectively, and $0.4 million and $1.2 million for the same periods in 2019. Accrued Expenses Accrued Expenses as of September 30, 2020 and December 31, 2019 are as follows: (In thousands) September 30, 2020 December 31, 2019 Bonus related compensation $ 4,291 $ 5,116 Employee related accruals 2,674 1,785 Other accrued expenses 1,730 1,047 Accrued expenses $ 8,695 $ 7,948 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
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. 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 projected payments adjusted for the index or rate in effect at the commencement date. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. All operating lease commitments with a lease term greater than 12 months are recognized as right to use assets and liabilities, on a discounted basis on the balance sheet. Effective October 21, 2020 the Company entered into an agreement for one of its Cambridge, Massachusetts facility leases. This agreement extended the terms of the lease to expire on February 29, 2032, with monthly contractual lease payments ranging from $0.4 million to $0.6 million. Leases with an initial term of 12 months or less are not recorded on the balance sheet and for both the three and nine months ended September 30, 2020 and 2019, lease expense of less than $0.1 million was recorded related to short-term leases. The contribution toward the cost of tenant improvements is recorded as a reduction of the operating lease assets. For the three and nine months ended September 30, 2020 , the Company recognized $1.6 million and $4.5 million of operating lease expense and $1.4 million and $4.0 million for the same periods in 2019. For both the three and nine months ended September 30, 2020 and 2019, the Company recognized less than $0.1 million of financing lease expense. The Company’s leases contain non-lease components and activities that do not transfer a good or service to the Company. The Company elected not to combine lease and non-lease components and therefore non-lease costs were not included in the net lease assets or lease liabilities. Total leased assets and liabilities classified on the balance sheet, as of September 30, 2020 and December 31, 2019 are as follows: (In thousands) Classification September 30, 2020 December 31, 2019 Assets Operating Right-of-use assets $ 24,796 $ 25,103 Finance Property and equipment, net 120 148 $ 24,916 $ 25,251 Liabilities Current Operating Current portion of operating lease liabilities $ 6,102 $ 5,461 Finance Other liabilities 41 41 $ 6,143 $ 5,502 Non-current Operating Operating lease liabilities $ 21,487 $ 22,242 Finance Other long-term liabilities 74 110 $ 21,561 $ 22,352 |
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. 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 projected payments adjusted for the index or rate in effect at the commencement date. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. All operating lease commitments with a lease term greater than 12 months are recognized as right to use assets and liabilities, on a discounted basis on the balance sheet. Effective October 21, 2020 the Company entered into an agreement for one of its Cambridge, Massachusetts facility leases. This agreement extended the terms of the lease to expire on February 29, 2032, with monthly contractual lease payments ranging from $0.4 million to $0.6 million. Leases with an initial term of 12 months or less are not recorded on the balance sheet and for both the three and nine months ended September 30, 2020 and 2019, lease expense of less than $0.1 million was recorded related to short-term leases. The contribution toward the cost of tenant improvements is recorded as a reduction of the operating lease assets. For the three and nine months ended September 30, 2020 , the Company recognized $1.6 million and $4.5 million of operating lease expense and $1.4 million and $4.0 million for the same periods in 2019. For both the three and nine months ended September 30, 2020 and 2019, the Company recognized less than $0.1 million of financing lease expense. The Company’s leases contain non-lease components and activities that do not transfer a good or service to the Company. The Company elected not to combine lease and non-lease components and therefore non-lease costs were not included in the net lease assets or lease liabilities. Total leased assets and liabilities classified on the balance sheet, as of September 30, 2020 and December 31, 2019 are as follows: (In thousands) Classification September 30, 2020 December 31, 2019 Assets Operating Right-of-use assets $ 24,796 $ 25,103 Finance Property and equipment, net 120 148 $ 24,916 $ 25,251 Liabilities Current Operating Current portion of operating lease liabilities $ 6,102 $ 5,461 Finance Other liabilities 41 41 $ 6,143 $ 5,502 Non-current Operating Operating lease liabilities $ 21,487 $ 22,242 Finance Other long-term liabilities 74 110 $ 21,561 $ 22,352 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
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 nonqualified 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 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, 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 2019 Omnibus Incentive Plan (2019 Plan) was approved on May 1, 2019 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 2019 Plan shall not be less than the fair market value of the Company’s common stock on the date of grant. The 2019 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 and the 2017 Omnibus Incentive Plan (Prior Plans), and no new grants have been granted under the Prior Plans after approval. However, the expiration or forfeiture of options previously granted under the Prior Plans will increase the number of shares available for issuance under the 2019 Plan. The Amended and Restated 2019 Omnibus Incentive Plan (Amended and Restated 2019 Plan) was approved on April 29, 2020. The Amended and Restated 2019 Plan increased the total number of shares of the Company’s common stock reserved for issuance under the 2019 Plan by 2,400,000 shares, revised the ratio at which “full-value” awards are counted against the share reserve from 1.25 to 1.4, and extended the term of the plan to April 29, 2030. As of September 30, 2020, there were 4,553,487 shares available for future grant under the Amended and Restated 2019 Plan. Employee Stock Purchase Plan Employees are able to purchase stock under the Vericel Corporation Employee Stock Purchase Plan (ESPP). The ESPP allows for the issuance of an aggregate of 1,000,000 shares of common stock of which 693,498 shares have been issued since the inception of the plan in 2015. Participation in this plan is available to substantially all employees. The ESPP is a compensatory plan accounted for under the expense recognition provisions of the share-based payment accounting standards. Compensation expense is recorded based on the fair market value of the options at the grant date, which corresponds to the first day of each purchase period and is amortized over the purchase period. In October 2020, employees purchased 20,591 shares resulting in proceeds from the sale of common stock of $0.3 million under the ESPP for the third quarter of 2020. Service-Based Stock Options During the three and nine months ended September 30, 2020, the Company granted service-based options to purchase common stock of 28,000 and 1,324,890, respectively, and 111,600 and 1,750,110, respectively, for the same periods in 2019. The exercise price of the options is the fair market value per share of common stock on the grant date, and the options generally vest over four years (other than non-employee director options which vest over one year) and have a term of ten years. The Company issues new shares upon the exercise of stock options. The weighted average grant-date fair value of service-based options granted during the three and nine months ended September 30, 2020 was $10.81 and $8.70, respectively and $13.28 and $12.77, respectively, for the same periods in 2019. Restricted Stock Units During the nine months ended September 30, 2020 and September 30, 2019, the Company granted 196,836 and 186,922 service-based restricted stock units, respectively. The restricted stock units vest annually over four years in equal installments commencing on the first anniversary of the grant date (other than non-employee director options which vest over one year from the grant date). The Company issues new shares upon the vesting of restricted stock units. Restricted stock awards are recorded at fair value at the date of grant, which is based on the closing share price on the grant date. Compensation expense is recorded for restricted stock units that are expected to vest based on their fair value at grant date and is amortized over the expected vesting period. The weighted average grant-date fair value of restricted stock units granted during the nine months ended September 30, 2020 was $11.41, and $17.71 for the same period in 2019. The aggregate fair value of restricted stock units granted in the nine months ended September 30, 2020 was $2.2 million, and $3.3 million for the same period in 2019. During the nine months ended September 30, 2020, 32,840 shares of common stock were issued upon the vesting of restricted stock units. These amounts are net of 13,872 shares, that were withheld for payment of taxes on the behalf of employees, during the nine months ended September 30, 2020. Stock Compensation Expense Non-cash stock-based compensation expense (employee stock purchase plan, service-based stock options and restricted stock units) included in cost of goods sold, research and development expenses and selling, general and administrative expenses is summarized in the following table: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2020 2019 2020 2019 Cost of goods sold $ 481 $ 543 $ 1,541 $ 1,519 Research and development 458 583 1,455 1,993 Selling, general and administrative 1,736 2,159 7,823 6,583 Total non-cash stock-based compensation expense $ 2,675 $ 3,285 $ 10,819 $ 10,095 |
Cash Equivalents and Investment
Cash Equivalents and Investments | 9 Months Ended |
Sep. 30, 2020 | |
Cash and Cash Equivalents [Abstract] | |
Cash Equivalents and Investments | Cash Equivalents and 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, 2020 and December 31, 2019: September 30, 2020 Gross Unrealized Estimated Fair Value Amortized Cost Gains Losses Credit Losses Money market funds $ 28,059 $ — $ — $ — $ 28,059 Commercial paper 9,984 — — — 9,984 Corporate notes 11,161 25 — — 11,186 U.S. government securities 13,764 40 — — 13,804 U.S. government agency bonds 3,498 1 — — 3,499 U.S. asset-backed securities 3,550 12 — — 3,562 $ 70,016 $ 78 $ — $ — $ 70,094 Classified as: Cash equivalents $ 28,059 Short-term investments 42,035 $ 70,094 December 31, 2019 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Money market funds $ 5,381 $ — $ — $ 5,381 Commercial paper 11,892 — — 11,892 Corporate notes 18,369 11 — 18,380 U.S. government securities 11,291 4 — 11,295 U.S. asset-backed securities 10,503 6 — 10,509 $ 57,436 $ 21 $ — $ 57,457 Classified as: Cash equivalents $ 5,381 Short-term investments 42,829 Long-term investments 9,247 $ 57,457 As of September 30, 2020 we held short-term investments and as of December 31, 2019, we held both short-term and long-term 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) we do 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 September 30, 2020 and December 31, 2019 , all marketable securities held by the Company had remaining contractual maturities of three years or less. U nrealized gains are included as a component of accumulated other comprehensive income in the condensed consolidated balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses , 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 income, net of taxes. There were no material realized losses on marketable securities for the three and nine months ended September 30, 2020 and 2019. The Company evaluated its investments for impairment under ASC 326. Any allowance for credit losses are recorded at the lower of either the fair market value less book value or the difference between the present value of future cash flows and the book value. As of September 30, 2020, the analysis under ASU 2016-13 and the current macroeconomic impact of the COVID-19 pandemic did not result in material allowances for credit losses. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2020 | |
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). There was no movement between Level 1 and Level 2 or between Level 2 and Level 3 from December 31, 2019 to September 30, 2020. 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, U.S. government securities, U.S. government agency bonds and U.S. asset-backed securities 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. The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis: September 30, 2020 December 31, 2019 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 $ 28,059 $ 28,059 $ — $ — $ 5,381 $ 5,381 $ — $ — Commercial paper 9,984 — 9,984 — 11,892 — 11,892 — Corporate notes 11,186 — 11,186 — 18,380 — 18,380 — U.S. government securities 13,804 — 13,804 — 11,295 — 11,295 — U.S. government agency bonds 3,499 — 3,499 — — — — — U.S. asset-backed securities 3,562 — 3,562 — 10,509 — 10,509 — $ 70,094 $ 28,059 $ 42,035 $ — $ 57,457 $ 5,381 $ 52,076 $ — The fair values of the cash equivalents and marketable securities are based on observable market prices. See note 8 for impact of ASU 2016-13 on the investment valuation. |
Net Income (Loss) Per Common Sh
Net Income (Loss) Per Common Share | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Common Share | Net Income (Loss) Per Common Share The following reflects the net income (loss) attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two class method: Three Months Ended September 30, Nine Months Ended September 30, (Amounts in thousands, except per share amounts) 2020 2019 2020 2019 Numerator: Net income (loss) $ 3,618 $ 3,470 $ (9,356) $ (19,166) Denominator: Weighted-average common shares outstanding (basic) 45,272 44,251 45,112 43,979 Weighted-average common shares outstanding (diluted) 47,314 46,667 45,112 43,979 Net income (loss) per share attributable to common shareholders (basic) $ 0.08 $ 0.08 $ (0.21) $ (0.44) Net income (loss) per share attributable to common shareholders (diluted) $ 0.08 $ 0.07 $ (0.21) $ (0.44) Anti-dilutive shares excluded from the calculation of diluted earnings per share (a) (amounts in millions): Stock options 2.4 1.6 5.7 5.1 Restricted stock unit awards — — 0.3 0.2 (a) Common equivalent shares are not included in the diluted per share calculation where the effect of their inclusion would be anti-dilutive. |
Nexobrid License and Supply Agr
Nexobrid License and Supply Agreements | 9 Months Ended |
Sep. 30, 2020 | |
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. NexoBrid is currently in clinical development in North America, and pursuant to the terms of the license agreement, MediWound will continue to conduct all clinical activities described in the development plan to support the Biologics License Application (BLA) filing with the United States Food and Drug Administration (FDA) under the supervision of a Central Steering Committee comprised of members of each party. On June 30, 2020, the Company announced the submission of the BLA to the FDA seeking the approval of NexoBrid. On September 16, 2020, the Company announced that the FDA has accepted the BLA for review and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 29, 2021. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets. In May 2019, the Company paid MediWound $17.5 million in consideration for the license. The $17.5 million upfront payment was recorded to research and development expense during 2019, as the license was considered in process research and development. 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 million 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 million. As of September 30, 2020, the milestone payments are not yet probable and therefore, not considered 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. The Company also entered into a supply agreement with MediWound under which MediWound will manufacture NexoBrid for the Company on a unit price basis which may be increased based on a published index. 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. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies 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. |
Basis of Presentation - (Polici
Basis of Presentation - (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Measuring Credit Losses on Financial Instruments The FASB issued updated guidance on measuring credit losses on financial instruments. The guidance removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. Prior to the updated guidance, credit losses were recognized when it was probable that the loss had been incurred. The revised guidance removes all recognition thresholds and requires companies to recognize an allowance for credit losses for the difference between the amortized cost basis of a financial instrument and the amount of amortized cost that a company expected to collect over the instrument’s contractual life. The Accounting Standard Update (ASU) 2016-13, Financial Instruments-Credit Losses (Topic 326) , became effective for the Company January 1, 2020. See note 4 and note 8 for further discussion. Fair Value Measurement Disclosure The FASB issued updated guidance through ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The revised guidance created a more consistent disclosure framework that increased clarity and removed, modified and added certain fair value disclosures to improve the effectiveness of the Company’s disclosures in the notes of the financial statements. This guidance became effective for the Company January 1, 2020 and had no impact on its condensed consolidated financial statements. Simplifying the Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740, including requirements related to hybrid tax regimes, the tax basis step-up in goodwill obtained in a transaction that is not a business combination, separate financial statements of entities not subject to tax, the intra-period tax allocation exception to the incremental approach, ownership changes in investments, changes from a subsidiary to an equity method investment, interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted. The Company is currently in the process of evaluating the impact on its condensed consolidated financial statements. |
Basis of Presentation (Tables)
Basis of Presentation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Supplementary cash flows information | The following table presents certain supplementary cash flows information for the nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, (In thousands) 2020 2019 Supplementary Cash Flows information: Non-cash information: Right-of-use asset and lease liability recognized $ 3,140 $ 2,338 Additions to property, plant and equipment included in accounts payable 340 46 Warrants exercised for common stock — 104 Cash information: Interest paid (net of interest capitalized) $ 5 $ 6 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Risks and Uncertainties [Abstract] | |
Disaggregation of Revenue | The following table and description below shows the products from which the Company generated its revenue: Three Months Ended September 30, Nine Months Ended September 30, Revenue by product (in thousands) 2020 2019 2020 2019 MACI implants and kits Implants based on contracted rate sold through a specialty pharmacy (a) $ 14,897 $ 11,779 $ 36,084 $ 34,555 Implants subject to third party reimbursement sold through a specialty pharmacy (b) 3,529 4,030 10,299 10,584 Implants sold direct based on contracted rates (c) 4,602 3,039 9,528 9,715 Implants sold direct subject to third party reimbursement (d) 782 573 1,793 1,176 Biopsy kits - direct bill 539 533 1,348 1,632 Change in estimates related to prior periods (e) 8 656 695 353 Epicel Direct bill (hospital) 6,663 9,889 17,965 20,445 Total product revenue $ 31,020 $ 30,499 $ 77,712 $ 78,460 Other revenue (f) 1,238 — 1,238 — Total net revenue $ 32,258 $ 30,499 $ 78,950 $ 78,460 (a) Represents implants sold through Orsini and AllCare in both 2020 and 2019 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 a payer or state fee schedule and/or payer history. (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 the 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 in which such specialty pharmacy does not have a direct contract with the underlying payer. The initial estimate of the amount of reimbursement is established based on a payer or state fee schedule and/or payer history. The change in estimates is a result of additional information or actual cash collections received in the current period. (f) Represents income from sales of NexoBrid to BARDA, pursuant to the license agreement between the Company and MediWound. |
Selected Balance Sheet Compon_2
Selected Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of inventory | Inventory as of September 30, 2020 and December 31, 2019: (In thousands) September 30, 2020 December 31, 2019 Raw materials $ 9,265 $ 6,085 Work-in-process 771 541 Finished goods 44 190 Inventory $ 10,080 $ 6,816 |
Schedule of property and equipment, net | Property and Equipment, net as of September 30, 2020 and December 31, 2019: (In thousands) September 30, 2020 December 31, 2019 Machinery and equipment $ 3,683 $ 3,152 Furniture, fixtures and office equipment 810 775 Computer equipment and software 6,585 6,174 Leasehold improvements 5,436 5,256 Construction in process 1,190 859 Financing right-of-use lease 120 148 Total property and equipment, gross 17,824 16,364 Less accumulated depreciation (10,709) (9,220) Property and equipment, net $ 7,115 $ 7,144 |
Schedule of accrued expenses | Accrued Expenses as of September 30, 2020 and December 31, 2019 are as follows: (In thousands) September 30, 2020 December 31, 2019 Bonus related compensation $ 4,291 $ 5,116 Employee related accruals 2,674 1,785 Other accrued expenses 1,730 1,047 Accrued expenses $ 8,695 $ 7,948 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Assets And Liabilities | Total leased assets and liabilities classified on the balance sheet, as of September 30, 2020 and December 31, 2019 are as follows: (In thousands) Classification September 30, 2020 December 31, 2019 Assets Operating Right-of-use assets $ 24,796 $ 25,103 Finance Property and equipment, net 120 148 $ 24,916 $ 25,251 Liabilities Current Operating Current portion of operating lease liabilities $ 6,102 $ 5,461 Finance Other liabilities 41 41 $ 6,143 $ 5,502 Non-current Operating Operating lease liabilities $ 21,487 $ 22,242 Finance Other long-term liabilities 74 110 $ 21,561 $ 22,352 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of non-cash stock-based compensation expense | Non-cash stock-based compensation expense (employee stock purchase plan, service-based stock options and restricted stock units) included in cost of goods sold, research and development expenses and selling, general and administrative expenses is summarized in the following table: Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2020 2019 2020 2019 Cost of goods sold $ 481 $ 543 $ 1,541 $ 1,519 Research and development 458 583 1,455 1,993 Selling, general and administrative 1,736 2,159 7,823 6,583 Total non-cash stock-based compensation expense $ 2,675 $ 3,285 $ 10,819 $ 10,095 |
Cash Equivalents and Investme_2
Cash Equivalents and Investments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020 and December 31, 2019: September 30, 2020 Gross Unrealized Estimated Fair Value Amortized Cost Gains Losses Credit Losses Money market funds $ 28,059 $ — $ — $ — $ 28,059 Commercial paper 9,984 — — — 9,984 Corporate notes 11,161 25 — — 11,186 U.S. government securities 13,764 40 — — 13,804 U.S. government agency bonds 3,498 1 — — 3,499 U.S. asset-backed securities 3,550 12 — — 3,562 $ 70,016 $ 78 $ — $ — $ 70,094 Classified as: Cash equivalents $ 28,059 Short-term investments 42,035 $ 70,094 December 31, 2019 Gross Unrealized Estimated Fair Value (In thousands) Amortized Cost Gains Losses Money market funds $ 5,381 $ — $ — $ 5,381 Commercial paper 11,892 — — 11,892 Corporate notes 18,369 11 — 18,380 U.S. government securities 11,291 4 — 11,295 U.S. asset-backed securities 10,503 6 — 10,509 $ 57,436 $ 21 $ — $ 57,457 Classified as: Cash equivalents $ 5,381 Short-term investments 42,829 Long-term investments 9,247 $ 57,457 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 December 31, 2019 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 $ 28,059 $ 28,059 $ — $ — $ 5,381 $ 5,381 $ — $ — Commercial paper 9,984 — 9,984 — 11,892 — 11,892 — Corporate notes 11,186 — 11,186 — 18,380 — 18,380 — U.S. government securities 13,804 — 13,804 — 11,295 — 11,295 — U.S. government agency bonds 3,499 — 3,499 — — — — — U.S. asset-backed securities 3,562 — 3,562 — 10,509 — 10,509 — $ 70,094 $ 28,059 $ 42,035 $ — $ 57,457 $ 5,381 $ 52,076 $ — |
Net Income (Loss) Per Common _2
Net Income (Loss) Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 | The following reflects the net income (loss) attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two class method: Three Months Ended September 30, Nine Months Ended September 30, (Amounts in thousands, except per share amounts) 2020 2019 2020 2019 Numerator: Net income (loss) $ 3,618 $ 3,470 $ (9,356) $ (19,166) Denominator: Weighted-average common shares outstanding (basic) 45,272 44,251 45,112 43,979 Weighted-average common shares outstanding (diluted) 47,314 46,667 45,112 43,979 Net income (loss) per share attributable to common shareholders (basic) $ 0.08 $ 0.08 $ (0.21) $ (0.44) Net income (loss) per share attributable to common shareholders (diluted) $ 0.08 $ 0.07 $ (0.21) $ (0.44) Anti-dilutive shares excluded from the calculation of diluted earnings per share (a) (amounts in millions): Stock options 2.4 1.6 5.7 5.1 Restricted stock unit awards — — 0.3 0.2 (a) Common equivalent shares are not included in the diluted per share calculation where the effect of their inclusion would be anti-dilutive. |
Organization - Narrative (Detai
Organization - Narrative (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2020USD ($)product | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2020USD ($)segmentproduct | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||
Number of therapy products | product | 2 | 2 | |||||||
Number of reportable segments | segment | 1 | ||||||||
Net (loss) income | $ 3,618 | $ (8,269) | $ (4,705) | $ 3,470 | $ (19,792) | $ (2,844) | $ (9,356) | $ (19,166) | |
Accumulated deficit | 388,035 | 388,035 | $ 378,679 | ||||||
Cash and cash equivalents | 43,507 | $ 36,900 | 43,507 | $ 36,900 | $ 26,889 | ||||
Short term investments | $ 42,000 | $ 42,000 |
Basis of Presentation - Supplem
Basis of Presentation - Supplementary cash flows information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Non-cash information: | ||
Right-of-use asset and lease liability recognized | $ 3,140 | $ 2,338 |
Additions to property, plant and equipment included in accounts payable | 340 | 46 |
Warrants exercised for common stock | 0 | 104 |
Interest paid (net of interest capitalized) | $ 5 | $ 6 |
Basis of Presentation - Narrati
Basis of Presentation - Narrative (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||||
Cash, cash equivalents, and restricted cash | $ 43,718,000 | $ 26,978,000 | $ 36,905,000 | $ 18,286,000 |
Cash and cash equivalents | 43,507,000 | $ 26,889,000 | 36,900,000 | |
Restricted cash | $ 200,000 | $ 0 |
Revenue - (Details)
Revenue - (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020USD ($)pharmacy | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)pharmacy | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
CONCENTRATION | |||||
Number of specialty pharmacies | pharmacy | 2 | 2 | |||
Allowance for doubtful accounts | $ 4,600 | $ 4,600 | $ 3,900 | ||
Change in estimate of uncollectible (percent) | 0.50% | ||||
Change in revenue recognized due to 0.5% change in uncollectible percentage | $ 200 | ||||
Increase (decrease) to revenues | 31,020 | $ 30,499 | 77,712 | $ 78,460 | |
Other revenue | 1,238 | 0 | 1,238 | 0 | |
Other | Provider or Facility | |||||
CONCENTRATION | |||||
Other revenue | 1,238 | 0 | 1,238 | 0 | |
Accounting Standards Update 2014-09 | Difference between Revenue Guidance in Effect before and after Topic 606 | |||||
CONCENTRATION | |||||
Increase (decrease) to revenues | 8 | $ 656 | 695 | $ 353 | |
COVID-19 potential impacts | |||||
CONCENTRATION | |||||
Allowance for doubtful accounts | $ 100 | $ 100 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | $ 31,020 | $ 30,499 | $ 77,712 | $ 78,460 |
Other revenue | 1,238 | 0 | 1,238 | 0 |
Total revenue | 32,258 | 30,499 | 78,950 | 78,460 |
Accounting Standards Update 2014-09 | Difference between Revenue Guidance in Effect before and after Topic 606 | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 8 | 656 | 695 | 353 |
MACI Implants and Kits, and Epicel | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 31,020 | 30,499 | 77,712 | 78,460 |
Through Intermediary | Implants | Contract rate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 14,897 | 11,779 | 36,084 | 34,555 |
Through Intermediary | Implants | Time-and-materials contract | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 3,529 | 4,030 | 10,299 | 10,584 |
Time-and-materials contract | Implants | Time-and-materials contract | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 782 | 573 | 1,793 | 1,176 |
Provider or Facility | Implants | Contract rate | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 4,602 | 3,039 | 9,528 | 9,715 |
Provider or Facility | Other | ||||
Disaggregation of Revenue [Line Items] | ||||
Other revenue | 1,238 | 0 | 1,238 | 0 |
Directly to consumer | Biopsy kits | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | 539 | 533 | 1,348 | 1,632 |
Directly to consumer | Epicel | ||||
Disaggregation of Revenue [Line Items] | ||||
Product sales, net | $ 6,663 | $ 9,889 | $ 17,965 | $ 20,445 |
Revenue - Schedules of concentr
Revenue - Schedules of concentration of risk (Details) | 3 Months Ended |
Sep. 30, 2019 | |
Revenue Concentration | Customer concentration | Epicel | |
Product Information [Line Items] | |
Concentration risk (as a percent) | 10.00% |
Selected Balance Sheet Compon_3
Selected Balance Sheet Components - Schedule of inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory: | ||
Raw materials | $ 9,265 | $ 6,085 |
Work-in-process | 771 | 541 |
Finished goods | 44 | 190 |
Inventory | $ 10,080 | $ 6,816 |
Selected Balance Sheet Compon_4
Selected Balance Sheet Components - Schedule of property and equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Property and equipment, net: | |||||
Financing right-of-use lease | $ 120 | $ 120 | $ 148 | ||
Total property and equipment, gross | 17,824 | 17,824 | 16,364 | ||
Less accumulated depreciation | (10,709) | (10,709) | (9,220) | ||
Property and equipment, net | 7,115 | 7,115 | 7,144 | ||
Depreciation expense | 600 | $ 400 | 1,600 | $ 1,200 | |
Machinery and equipment | |||||
Property and equipment, net: | |||||
Total property and equipment, gross | 3,683 | 3,683 | 3,152 | ||
Furniture, fixtures and office equipment | |||||
Property and equipment, net: | |||||
Total property and equipment, gross | 810 | 810 | 775 | ||
Computer equipment and software | |||||
Property and equipment, net: | |||||
Total property and equipment, gross | 6,585 | 6,585 | 6,174 | ||
Leasehold improvements | |||||
Property and equipment, net: | |||||
Total property and equipment, gross | 5,436 | 5,436 | 5,256 | ||
Construction in process | |||||
Property and equipment, net: | |||||
Total property and equipment, gross | $ 1,190 | $ 1,190 | $ 859 |
Selected Balance Sheet Compon_5
Selected Balance Sheet Components - Schedule of accrued expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accrued expenses | ||
Bonus related compensation | $ 4,291 | $ 5,116 |
Employee related accruals | 2,674 | 1,785 |
Other accrued expenses | 1,730 | 1,047 |
Accrued expenses | $ 8,695 | $ 7,948 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Millions | Oct. 21, 2020USD ($)lease | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) |
Lessee, Lease, Description [Line Items] | |||||
Short-term lease costs (less than) | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | |
Operating lease expense | 1.6 | 1.4 | 4.5 | 4 | |
Finance lease expense | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 | |
Subsequent event | |||||
Lessee, Lease, Description [Line Items] | |||||
Number of leases renewed | lease | 1 | ||||
Minimum | Subsequent event | |||||
Lessee, Lease, Description [Line Items] | |||||
Monthly contractual payments | $ 0.4 | ||||
Maximum | Subsequent event | |||||
Lessee, Lease, Description [Line Items] | |||||
Monthly contractual payments | $ 0.6 |
Leases - Assets And Liabilities
Leases - Assets And Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Assets | ||
Operating | $ 24,796 | $ 25,103 |
Finance | 120 | 148 |
Right-of-use assets | 24,916 | 25,251 |
Current | ||
Operating | 6,102 | 5,461 |
Finance | 41 | 41 |
Lease liability current | 6,143 | 5,502 |
Non-current | ||
Operating | 21,487 | 22,242 |
Finance | 74 | 110 |
Lease liability noncurrent | $ 21,561 | $ 22,352 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:PropertyPlantAndEquipmentAndFinanceLeaseRightOfUseAssetAfterAccumulatedDepreciationAndAmortization | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 69 Months Ended | ||||||||
Oct. 31, 2020USD ($)shares | Sep. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($)shares | Mar. 31, 2020USD ($)shares | Sep. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2019USD ($)shares | Mar. 31, 2019USD ($)shares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($)$ / sharesshares | Sep. 30, 2020shares | Apr. 29, 2020shares | Apr. 28, 2020 | |
Stock-Based Compensation | ||||||||||||
Shares issued under the Employee Stock Purchase Plan (in shares) | $ | $ 309 | $ 257 | $ 224 | $ 275 | $ 211 | $ 218 | ||||||
Employee stock | ||||||||||||
Stock-Based Compensation | ||||||||||||
Common stock available for issuance (in shares) | 1,000,000 | 1,000,000 | 1,000,000 | |||||||||
Common stock granted since inception (in shares) | 693,498 | |||||||||||
Employee stock | Subsequent event | ||||||||||||
Stock-Based Compensation | ||||||||||||
Shares purchased during period (in shares) | 20,591 | |||||||||||
Shares issued under the Employee Stock Purchase Plan (in shares) | $ | $ 300 | |||||||||||
Service-based stock options | ||||||||||||
Stock-Based Compensation | ||||||||||||
Expiration period | 10 years | |||||||||||
Vesting period | 4 years | |||||||||||
Granted (in shares) | 28,000 | 111,600 | 1,324,890 | 1,750,110 | ||||||||
Weighted average grant-date fair value (in dollars per share) | $ / shares | $ 10.81 | $ 13.28 | $ 8.70 | $ 12.77 | ||||||||
Service-based stock options | Nonemployee directors | ||||||||||||
Stock-Based Compensation | ||||||||||||
Expiration period | 10 years | |||||||||||
Vesting period | 1 year | |||||||||||
Restricted Stock Units (RSUs) | ||||||||||||
Stock-Based Compensation | ||||||||||||
Vesting period | 4 years | |||||||||||
Restricted stock units granted (shares) | 196,836 | 186,922 | ||||||||||
Weighted-average grant date fair value (in usd per share) | $ / shares | $ 11.41 | $ 17.71 | ||||||||||
Grant-date fair value of restricted stock units granted | $ | $ 2,200 | $ 3,300 | ||||||||||
Shares vested in period (shares) | 32,840 | |||||||||||
Restricted stock withheld for employee tax remittance (in shares) | 13,872 | |||||||||||
Restricted Stock Units (RSUs) | Nonemployee directors | ||||||||||||
Stock-Based Compensation | ||||||||||||
Vesting period | 1 year | |||||||||||
Common Stock | ||||||||||||
Stock-Based Compensation | ||||||||||||
Shares purchased during period (in shares) | 44,000 | 32,000 | 20,000 | 18,000 | 14,000 | 19,000 | ||||||
Shares issued under the Employee Stock Purchase Plan (in shares) | $ | $ 309 | $ 257 | $ 224 | $ 275 | $ 211 | $ 218 | ||||||
Restricted stock withheld for employee tax remittance (in shares) | 14,000 | |||||||||||
Prior Plans | ||||||||||||
Stock-Based Compensation | ||||||||||||
Awards available for future grant under the Plan (in shares) | 0 | 0 | 0 | |||||||||
Omnibus Incentive Plan 2019 | ||||||||||||
Stock-Based Compensation | ||||||||||||
Awards available for future grant under the Plan (in shares) | 4,553,487 | 4,553,487 | 4,553,487 | |||||||||
Ratio of full value awards against share reserve | 1.4 | 1.25 | ||||||||||
Omnibus Incentive Plan 2019 | Common Stock | ||||||||||||
Stock-Based Compensation | ||||||||||||
Increase in number of shares available for issuance (shares) | 2,400,000 |
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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | $ 2,675 | $ 3,285 | $ 10,819 | $ 10,095 |
Cost of goods sold | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | 481 | 543 | 1,541 | 1,519 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | 458 | 583 | 1,455 | 1,993 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total non-cash stock-based compensation expense | $ 1,736 | $ 2,159 | $ 7,823 | $ 6,583 |
Cash Equivalents and Investme_3
Cash Equivalents and Investments (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 70,016,000 | $ 57,436,000 |
Gains | 78,000 | 21,000 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | $ 70,094,000 | $ 57,457,000 |
Remaining contractual maturity period | 3 years | 3 years |
Impairments of assets | $ 0 | |
Cash equivalents | ||
Marketable Securities [Line Items] | ||
Estimated Fair Value | 28,059,000 | $ 5,381,000 |
Short-term investments | ||
Marketable Securities [Line Items] | ||
Estimated Fair Value | 42,035,000 | 42,829,000 |
Long-term investments | ||
Marketable Securities [Line Items] | ||
Estimated Fair Value | 9,247,000 | |
Money market funds | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 28,059,000 | 5,381,000 |
Gains | 0 | 0 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | 28,059,000 | 5,381,000 |
Commercial paper | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 9,984,000 | 11,892,000 |
Gains | 0 | 0 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | 9,984,000 | 11,892,000 |
Corporate notes | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 11,161,000 | 18,369,000 |
Gains | 25,000 | 11,000 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | 11,186,000 | 18,380,000 |
U.S. government securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 13,764,000 | 11,291,000 |
Gains | 40,000 | 4,000 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | 13,804,000 | 11,295,000 |
U.S. government agency bonds | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,498,000 | |
Gains | 1,000 | |
Losses | 0 | |
Credit Losses | 0 | |
Estimated Fair Value | 3,499,000 | |
U.S. asset-backed securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,550,000 | 10,503,000 |
Gains | 12,000 | 6,000 |
Losses | 0 | 0 |
Credit Losses | 0 | |
Estimated Fair Value | $ 3,562,000 | $ 10,509,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | $ 70,094 | $ 57,457 |
Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 70,094 | 57,457 |
Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 28,059 | 5,381 |
Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 42,035 | 52,076 |
Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Assets, fair value | 0 | 0 |
Commercial paper | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 9,984 | 11,892 |
Commercial paper | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Commercial paper | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 9,984 | 11,892 |
Commercial paper | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Corporate Note Securities | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 11,186 | 18,380 |
Corporate Note Securities | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Corporate Note Securities | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 11,186 | 18,380 |
Corporate Note Securities | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
U.S. government securities | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 13,804 | 11,295 |
U.S. government securities | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 13,804 | 11,295 |
U.S. government securities | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
U.S. government securities | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 13,804 | 11,295 |
U.S. government securities | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
U.S. government agency bonds | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,499 | |
U.S. government agency bonds | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,499 | 0 |
U.S. government agency bonds | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
U.S. government agency bonds | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,499 | 0 |
U.S. government agency bonds | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Asset-backed Securities | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,562 | 10,509 |
Asset-backed Securities | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,562 | 10,509 |
Asset-backed Securities | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Asset-backed Securities | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 3,562 | 10,509 |
Asset-backed Securities | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Debt securities, fair value | 0 | 0 |
Money market funds | Recurring | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 28,059 | 5,381 |
Money market funds | Recurring | Level 1 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 28,059 | 5,381 |
Money market funds | Recurring | Level 2 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | 0 | 0 |
Money market funds | Recurring | Level 3 | ||
Liabilities that are measured at fair value on a recurring basis | ||
Money market funds | $ 0 | $ 0 |
Net Income (Loss) Per Common _3
Net Income (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Numerator: | ||||||||
Net income (loss) | $ 3,618 | $ (8,269) | $ (4,705) | $ 3,470 | $ (19,792) | $ (2,844) | $ (9,356) | $ (19,166) |
Weighted average number of common shares outstanding (Basic) (in shares) | 45,272 | 44,251 | 45,112 | 43,979 | ||||
Weighted average number of common shares outstanding (Diluted) (in shares) | 47,314 | 46,667 | 45,112 | 43,979 | ||||
Net (loss) income per share (Basic) (in USD per share) | $ 0.08 | $ 0.08 | $ (0.21) | $ (0.44) | ||||
Net (loss) income per share (Diluted) (in USD per share) | $ 0.08 | $ 0.07 | $ (0.21) | $ (0.44) | ||||
Service-based stock options | ||||||||
Denominator for basic and diluted EPS: | ||||||||
Aggregate number of common equivalent shares (related to options, warrants and preferred stock) that have been excluded from computations of diluted net loss per common share (in shares) | 2,400 | 1,600 | 5,700 | 5,100 | ||||
Restricted Stock Units (RSUs) | ||||||||
Denominator for basic and diluted EPS: | ||||||||
Aggregate number of common equivalent shares (related to options, warrants and preferred stock) that have been excluded from computations of diluted net loss per common share (in shares) | 0 | 0 | 300 | 200 |
Nexobrid License and Supply A_2
Nexobrid License and Supply Agreements (Details) - MediWound Ltd $ in Millions | 1 Months Ended |
May 31, 2019USD ($) | |
Related Party Transaction [Line Items] | |
Consideration payment for license | $ 17.5 |
Payable | 17.5 |
Contingent consideration | 7.5 |
Max contingent consideration | 125 |
Sales Initial milestone | $ 75 |