Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 24, 2021 | Jun. 30, 2020 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Transition Report | false | ||
Entity File Number | 1-32639 | ||
Entity Registrant Name | TG THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 36-3898269 | ||
Entity Address, Address Line One | 2 Gansevoort St. | ||
Entity Address, Address Line Two | 9th Floor | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10014 | ||
City Area Code | 212 | ||
Local Phone Number | 554-4484 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | TGTX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | No | ||
Entity Filer Category | Large Accelerated Filer | ||
ICFR Auditor Attestation Flag | true | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 2,163,126,348 | ||
Entity Common Stock, Shares Outstanding | 140,586,187 | ||
Entity Central Index Key | 0001001316 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 553,439 | $ 112,637 |
Short-term investment securities | 51,987 | 27,798 |
Prepaid research and development | 5,231 | 8,105 |
Other current assets | 1,083 | 611 |
Total current assets | 611,740 | 149,151 |
Restricted cash | 1,259 | 1,251 |
Leasehold interest, net | 2,051 | 2,129 |
Equipment, net | 481 | 282 |
Right-of-use-assets | 9,312 | 9,402 |
Goodwill | 799 | 799 |
Total assets | 625,642 | 163,014 |
Current liabilities: | ||
Accounts payable and accrued expenses | 37,014 | 30,041 |
Other current liabilities | 18,236 | 48,994 |
Loan payable - current portion | 22,179 | 0 |
Lease liability - current portion | 1,669 | 1,616 |
Accrued compensation | 8,456 | 3,798 |
Total current liabilities | 87,554 | 84,449 |
Deferred revenue, net of current portion | 610 | 762 |
Long-term debt | 7,716 | 28,970 |
Lease liability - non-current | 10,412 | 10,218 |
Total liabilities | 106,292 | 124,399 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value per share (10,000,000 shares authorized, none issued and outstanding as of December 31, 2020 and December 31, 2019) | 0 | 0 |
Common stock, $0.001 par value per share (150,000,000 shares authorized, 140,617,606 and 109,425,243 shares issued, 140,576,297 and 109,383,934 shares outstanding at December 31, 2020 and December 31, 2019, respectively) | 141 | 109 |
Additional paid-in capital | 1,500,040 | 739,956 |
Treasury stock, at cost, 41,309 shares at December 31, 2020 and December 31, 2019 | (234) | (234) |
Accumulated deficit | (980,597) | (701,216) |
Total stockholders' equity | 519,350 | 38,615 |
Total liabilities and stockholders' equity | $ 625,642 | $ 163,014 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 140,617,606 | 109,425,243 |
Common stock, shares outstanding | 140,576,297 | 109,383,934 |
Treasury stock, shares | 41,309 | 41,309 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
License revenue | $ 152 | $ 152 | $ 152 |
Research and development: | |||
Noncash stock expense associated with in-licensing agreements | 0 | 100 | 4,000 |
Noncash compensation | 13,962 | 5,811 | 5,598 |
Other research and development | 151,934 | 148,269 | 149,793 |
Total research and development | 165,896 | 154,180 | 159,391 |
General and administrative: | |||
Noncash compensation | 66,327 | 5,523 | 7,288 |
Other general and administrative | 41,523 | 9,504 | 7,873 |
Total general and administrative | 107,850 | 15,027 | 15,161 |
Total costs and expenses | 273,746 | 169,207 | 174,552 |
Operating loss | (273,594) | (169,055) | (174,400) |
Other expense (income): | |||
Interest expense | 6,329 | 5,287 | 877 |
Other income | (542) | (1,471) | (1,795) |
Total other expense (income), net | 5,787 | 3,816 | (918) |
Net loss | $ (279,381) | $ (172,871) | $ (173,482) |
Basic and diluted net loss per common share (in dollars per share) | $ (2.42) | $ (1.96) | $ (2.30) |
Weighted average shares used in computing basic and diluted net loss per common share (in shares) | 115,333,693 | 88,368,844 | 75,466,813 |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 73 | $ 422,017 | $ (234) | $ (354,863) | $ 66,993 |
Balance (in shares) at Dec. 31, 2017 | 73,181,750 | 41,309 | |||
Issuance of restricted stock | $ 2 | (2) | |||
Issuance of restricted stock (in shares) | 1,562,211 | ||||
Forfeiture of restricted stock (in shares) | (191,196) | ||||
Issuance of common stock in At-the-Market offerings (net of offering costs) | $ 9 | 113,630 | 113,639 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 9,025,222 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 12,886 | 12,886 | |||
Shares issued in connection with in-licensing agreements | 4,000 | 4,000 | |||
Shares issued in connection with in-licensing agreements (in shares) | 333,868 | ||||
Net loss | (173,482) | (173,482) | |||
Balance at Dec. 31, 2018 | $ 84 | 552,531 | $ (234) | (528,345) | 24,036 |
Balance (in shares) at Dec. 31, 2018 | 83,911,855 | 41,309 | |||
Issuance of restricted stock | $ 1 | (1) | |||
Issuance of restricted stock (in shares) | 1,851,520 | ||||
Warrants issued with debt financing | 993 | 993 | |||
Forfeiture of restricted stock (in shares) | (116,463) | ||||
Issuance of common stock (net of offering costs) | $ 10 | 77,465 | 77,475 | ||
Issuance of common stock (net of offering costs) (in shares) | 10,149,783 | ||||
Issuance of common stock in At-the-Market offerings (net of offering costs) | $ 14 | 97,533 | 97,547 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 13,620,165 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 11,335 | 11,335 | |||
Shares issued in connection with in-licensing agreements | 100 | 100 | |||
Shares issued in connection with in-licensing agreements (in shares) | 8,383 | ||||
Net loss | (172,871) | (172,871) | |||
Balance at Dec. 31, 2019 | $ 109 | 739,956 | $ (234) | (701,216) | 38,615 |
Balance (in shares) at Dec. 31, 2019 | 109,425,243 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 146 | 146 | |||
Issuance of common stock in connection with exercise of options | 35,814 | ||||
Issuance of restricted stock | $ 5 | (5) | |||
Issuance of restricted stock (in shares) | 4,909,829 | ||||
Forfeiture of restricted stock (in shares) | (128,666) | ||||
Issuance of common stock (net of offering costs) | $ 17 | 462,212 | 462,229 | ||
Issuance of common stock (net of offering costs) (in shares) | 17,043,000 | ||||
Issuance of common stock in At-the-Market offerings (net of offering costs) | $ 10 | 217,442 | 217,452 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 9,332,386 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 80,289 | 80,289 | |||
Net loss | (279,381) | (279,381) | |||
Balance at Dec. 31, 2020 | $ 141 | $ 1,500,040 | $ (234) | $ (980,597) | $ 519,350 |
Balance (in shares) at Dec. 31, 2020 | 140,617,606 | 41,309 |
Consolidated Statements of Eq_2
Consolidated Statements of Equity (Parenthetical) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Stockholders' Equity [Abstract] | |||
Offering costs | $ 29.9 | $ 0.2 | $ 2 |
Offering costs, at market | $ 4 | $ 2 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||
Net loss | $ (279,381) | $ (172,871) | $ (173,482) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Total expenses | 80,289 | 11,335 | 12,886 |
Shares issued in connection with in-licensing agreement | 0 | 100 | 4,000 |
Depreciation and amortization | 158 | 100 | 88 |
Amortization of premium on investment securities | (30) | (257) | (119) |
Amortization of debt issuance costs | 925 | 772 | 0 |
Amortization of leasehold interest | 216 | 182 | 135 |
Noncash change in lease liability and right-of-use asset | 2,325 | 2,519 | 0 |
Change in fair value of notes payable | 748 | 124 | (61) |
Changes in assets and liabilities: | |||
Decrease (increase) in other current assets | 2,263 | 1,395 | (1,638) |
(Increase) decrease in accrued interest receivable | (6) | (11) | 14 |
Increase (decrease) in accounts payable and accrued expenses | 11,631 | (4,795) | 10,957 |
(Decrease) increase in lease liabilities | (1,988) | (1,548) | 0 |
(Decrease) Increase in interest payable | (43) | 1,491 | 0 |
(Decrease) increase in other liabilities | (31,462) | 28,810 | 18,350 |
Decrease in deferred revenue | (152) | (152) | (152) |
Net cash used in operating activities | (214,507) | (132,806) | (128,925) |
CASH FLOWS FROM INVESTING ACTIVITIES | |||
Proceeds from maturity of short-term securities | 43,250 | 29,250 | 32,500 |
Investment in held-to-maturity securities | (67,403) | (29,837) | (31,230) |
Purchases of equipment | (357) | (131) | (90) |
Net cash (used in) provided by investing activities | (24,510) | (718) | 1,180 |
CASH FLOWS FROM FINANCING ACTIVITIES | |||
Proceeds from sale of common stock, net | 679,680 | 175,021 | 113,639 |
Proceeds from exercise of options | 147 | 0 | 0 |
Proceeds from debt financings | 0 | 29,987 | 0 |
Financing costs paid | 0 | (795) | 0 |
Net cash provided by financing activities | 679,827 | 204,213 | 113,639 |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 440,810 | 70,689 | (14,106) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF YEAR | 113,888 | 43,199 | 57,305 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR | $ 554,698 | $ 113,888 | $ 43,199 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation to amounts on condensed consolidated balance sheets: | |||
Cash and cash equivalents | $ 553,439 | $ 112,637 | $ 41,958 |
Restricted cash | 1,259 | 1,251 | 1,241 |
Total cash, cash equivalents and restricted cash | 554,698 | 113,888 | 43,199 |
Cash paid for: | |||
Interest | 4,501 | 2,622 | 0 |
NONCASH TRANSACTIONS | |||
Deferred financing costs | 0 | 988 | 0 |
Warrants issued with debt financing | 0 | 993 | 0 |
Shares issued in connection with in-licensing | $ 0 | $ 100 | $ 4,000 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES DESCRIPTION OF BUSINESS LIQUIDITY AND CAPITAL RESOURCES We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never become profitable. As of December 31, 2020, we have an accumulated deficit of $980.6 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities, and in 2019 from our loan and security agreement executed with Hercules Capital, Inc. (“Hercules”) (see Note 7 for more information). As of December 31, 2020 we had not yet generated revenue from drug sales of UKONIQ. UKONIQ first became commercially available in the United States in February of 2021. Even with the commercialization of UKONIQ and the future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of December 31, 2020, we had $605.4 million in cash and cash equivalents, and investment securities. We anticipate that our cash and cash equivalents, and investment securities as of December 31, 2020 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K , during which time the Company plans to continue to commercialize UKONIQ in the United States, which commenced in February 2021. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.” RECENTLY ISSUED ACCOUNTING STANDARDS In July 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2018-11, Leases - Targeted Improvements Leases ASU 2018-11 provides an entity with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new lease standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new lease standard will continue to be in accordance with Accounting Standards Codification (“ASC”) ASC 840, Leases ASU 2018-11 is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlier adoption permitted. The Company adopted ASU 2018-11 on January 1, 2019 using a modified retrospective method and will not restate comparative periods. We elected the package of practical expedients permitted under the transition guidance, which allows us to carry forward our historical lease classification and our assessment on whether a contract is or contains a lease. The adoption of this guidance resulted in the addition of material balances of ROU assets and lease liabilities to our consolidated balance sheets at January 1, 2019, primarily relating to our lease of office space (see Note 8). The impact to our consolidated statements of operations was not material as a result of this standard. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation – Stock Compensation ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted ASU 2018-07 on January 1, 2019. The adoption of ASU 2018-07 did not have a material effect on our consolidated financial statements as of January 1, 2019. The adoption of ASU 2018-07 had no impact on nonemployee performance awards as they are measured based on the outcome that is probable. Other pronouncements issued by the FASB or other authoritative accounting standards with future effective dates are either not applicable or not significant to our consolidated financial statements. USE OF ESTIMATES The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued clinical trial expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. CASH AND CASH EQUIVALENTS We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. RESTRICTED CASH We record cash pledged or held in trust as restricted cash. As of December 31, 2020 and 2019, we have approximately $1.3 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 8). INVESTMENT SECURITIES Investment securities at both December 31, 2020 and 2019 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Dividend and interest income are recognized when earned. CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents and short-term investments with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. REVENUE RECOGNITION Effective January 1, 2018, the Company began recognizing revenue under ASC Topic 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of certain costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period for expenses that are not explicitly defined by contractual rates and terms. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to an initial negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. As such, certain expense accruals related to clinical site costs are recognized based on our estimate of the degree of performance of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, costs related to agreements with CROs, certain costs to third-party service providers related to development and manufacturing services as well as clinical development. These agreements often require payments in advance of services performed or goods received. Accordingly, as of December 31, 2020 and December 31, 2019, we recorded approximately $5.2 million and $8.1 million, respectively, in prepaid research and development related to such advance agreements. INCOME TAXES Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 9 for further information on impact of tax reform. The Coronavirus Aid, Relief, and Economic Security Act of 2020 (“CARES Act”) was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States. There are several provisions of the CARES Act that were considered in the December 31, 2020 year-end tax provision. However, the Company chose not to utilize any provisions or participate in certain programs due to lack of a benefit to the Company. STOCK-BASED COMPENSATION We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements based on the fair values of such payments. Stock-based compensation expense recognized each period is based on the value of the portion of stock-based payment awards that is ultimately expected to vest during the period. Forfeitures are recognized as they occur. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable. BASIC AND DILUTED NET LOSS PER COMMON SHARE Basic net loss per share of our common stock is calculated by dividing net loss applicable to the common stock by the weighted-average number of our common stock outstanding for the period. Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentially dilutive securities excluded from the calculation were 11,976,276, 8,361,739 and 6,528,932 at December 31, 2020, 2019 and 2018, respectively. During the years ended December 31, 2020, 2019 and 2018, the Company incurred a net loss; therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share. December 31, 2020 2019 2018 Unvested restricted stock 9,285,020 5,591,786 4,595,689 Options 2,526,166 2,605,730 1,916,900 Warrants 147,058 147,058 — Shares issuable upon note conversion 18,032 17,165 16,343 Total 11,976,276 8,361,739 6,528,932 LONG-LIVED ASSETS AND GOODWILL Long-lived assets are reviewed for potential impairment when circumstances indicate that the carrying value of long-lived tangible and intangible assets with finite lives may not be recoverable. Management’s policy in determining whether an impairment indicator exists, a triggering event, comprises measurable operating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions in determining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized. Goodwill is reviewed for impairment annually, or earlier when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process. The first step compares the fair value of the reporting unit with the unit’s carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. There was no impairment to goodwill as of December 31, 2020. |
CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS | 12 Months Ended |
Dec. 31, 2020 | |
CASH. AND CASH EQUIVALENTS | |
CASH AND CASH EQUIVALENTS | NOTE 2 – CASH AND CASH EQUIVALENTS The following tables summarize our cash and cash equivalents at December 31, 2020 and 2019: December 31, December 31, (in thousands) 2020 2019 Checking and bank deposits $ 399,879 $ 110,135 Money market funds 153,560 2,502 Total $ 553,439 $ 112,637 |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 12 Months Ended |
Dec. 31, 2020 | |
INVESTMENT SECURITIES | |
INVESTMENT SECURITIES | NOTE 3 – INVESTMENT SECURITIES Our investments as of December 31, 2020 and 2019 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following tables summarize our investment securities at December 31, 2020 and 2019: December 31, 2020 Amortized Gross Gross cost, as unrealized unrealized Estimated fair adjusted holding gains holding losses value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2021 and December 2021) (held-to-maturity) $ 51,987 $ 1 $ 4 $ 51,984 Total short-term investment securities $ 51,987 $ 1 $ 4 $ 51,984 December 31, 2019 Amortized Gross Gross cost, as unrealized unrealized Estimated fair adjusted holding gains holding losses value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2020 and September 2020) (held-to-maturity) $ 27,798 $ 28 $ — $ 27,826 Total short-term investment securities $ 27,798 $ 28 $ — $ 27,826 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | NOTE 4 – FAIR VALUE MEASUREMENTS We measure certain financial assets and liabilities at fair value on a recurring basis in the financial statements. The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: ● Level 1 – quoted prices in active markets for identical assets and liabilities; ● Level 2 – inputs other than Level 1 quoted prices that are directly or indirectly observable; and ● Level 3 – unobservable inputs that are not corroborated by market data. As of December 31, 2020 and 2019, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable approximate their carrying value. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (“Manhattan”)) with Ariston Pharmaceuticals, Inc. (“Ariston”) in March 2010, Ariston issued $15.5 million of five-year 5% notes payable (the “5% Notes”) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. Ariston agreed to make quarterly payments on the 5% Notes equal to 50% of the net product cash flow received from the exploitation or commercialization of Ariston’s product candidates, AST-726 and AST-915. We have no obligations under the 5% Notes aside from a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and b) the conversion feature, discussed above. The cumulative liability including accrued and unpaid interest of the 5% Notes was approximately $20.3 million at December 31, 2020 and $19.3 million at December 31, 2019. No payments have been made on the 5% Notes through December 31, 2020. In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments. As of December 31, 2013, as a result of expiring intellectual property rights and other factors, it was determined that net product cash flows from AST-726 were unlikely. As we have no other obligations under the 5% Notes aside from the net product cash flows and the conversion feature, the conversion feature was used to estimate the 5% Notes’ fair value as of December 31, 2020 and 2019. The assumptions, assessments and projections of future revenues are subject to uncertainties, difficult to predict, and require significant judgment. The use of different assumptions, applying different judgment to inherently subjective matters and changes in future market conditions could result in significantly different estimates of fair value and the differences could be material to our consolidated financial statements. The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2020 and 2019: Financial liabilities at fair value as of December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 938 $ 938 Total $ — $ — $ 938 $ 938 Financial liabilities at fair value as of December 31, 2019 Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 190 $ 190 Total $ — $ — $ 190 $ 190 The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest. The following table summarizes the changes in Level 3 instruments for the years ended December 31, 2019 and 2020: (in thousands) Balance at January 1, 2019 $ 67 Interest accrued on face value of 5% Notes 924 Conversion of 5% Notes — Change in fair value of Level 3 liabilities (801) Balance at December 31, 2019 190 Interest accrued on face value of 5% Notes 976 Conversion of 5% Notes — Change in fair value of Level 3 liabilities (228) Balance at December 31, 2020 $ 938 The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2020 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 5 – STOCKHOLDERS’ EQUITY Preferred Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 10,000,000 shares of preferred stock, $0.001 par value, with rights senior to those of our common stock, issuable in one or more series. Upon issuance, the Company can determine the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock. Stockholder Rights Plan On July 18, 2014, we adopted a stockholder rights plan. The stockholder rights plan is embodied in the Stockholder Protection Rights Agreement dated as of July 18, 2014 (the "Rights Agreement"), between us and American Stock Transfer & Trust Company, LLC, as rights agent (the "Rights Agent"). Accordingly, the Board of Directors declared a distribution of one right (a “Right”) for each outstanding share of common stock, to stockholders of record at the close of business on July 28, 2014, for each share of common stock issued (including shares distributed from Treasury) by us thereafter and prior to the Separation Time (as defined in the Rights Agreement), and for certain shares of common stock issued after the Separation Time. Following the Separation Time, each Right entitles the registered holder to purchase from us one one-thousandth one-thousandth The Rights Agreement was approved by our Board of Directors on July 18, 2014. The Rights will expire at the close of business on its ten-year anniversary, unless earlier exchanged or terminated by us. Common Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 150,000,000 shares of $0.001 par value common stock. In May 2017, we filed a shelf registration statement on Form S-3 (the "2017 S-3"), which was declared effective in June 2017, replacing the 2015 S-3. Under the 2017 S-3, we may sell up to a total of $300 million of securities. In connection with the 2017 S-3, we entered into an At-the-Market Issuance Sales Agreement (the "2017 ATM") with Jefferies LLC, Cantor Fitzgerald & Co., FBR Capital Markets & Co., SunTrust Robinson Humphrey, Inc., Raymond James & Associates, Inc., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC (each a "2017 Agent" and collectively, the "2017 Agents"), relating to the sale of shares of our common stock. Under the 2017 ATM we pay the 2017 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. During the year ended December 31, 2018, we sold a total of 9,025,222 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $115.8 million at an average selling price of $12.83 per share, resulting in net proceeds of approximately $113.7 million after deducting commissions and other transactions costs. During the year ended December 31, 2019, we sold a total of 13,620,165 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $99.3 million at an average selling price of $7.29 per share, resulting in net proceeds of approximately $97.5 million after deducting commissions and other transactions costs. On March 1, 2019, we completed a public offering of 4,100,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 615,000 shares of common stock, which was exercised) at a price of $5.87 per share. Net proceeds from this offering, including the overallotment, were approximately $27.5 million after underwriting discounts and offering expenses of approximately $0.2 million. On September 5, 2019, we filed an automatic “shelf registration” statement on Form S-3 (the “2019 WKSI Shelf”) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale. The 2019 WKSI Shelf was declared effective in September 2019. In connection with the 2019 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the “2020 ATM”) with Jefferies LLC, Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (each a “2020 Agent” and collectively, the “2020 Agents”), relating to the sale of shares of our common stock. Under the 2020 ATM, we pay the 2020 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. In November 2020, we entered into an At-the-Market Issuance Sales Agreement (the “2021 ATM”) with the same terms and agents (each a “2021 Agent” and collectively, the “2021 Agents”) as the 2020 ATM. During the year ended December 31, 2020, we sold a total of 8,528,286 shares of common stock under the 2020 ATM for aggregate total gross proceeds of approximately $187.5 million at an average selling price of $21.99 per share, resulting in net proceeds of approximately $184.2 million after deducting commissions and other transactions costs. During the year ended December 31, 2020, we sold a total of 804,100 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $33.9 million at an average selling price of $42.18 per share, resulting in net proceeds of approximately $33.3 million after deducting commissions and other transactions costs. On December 22, 2019, we completed a securities purchase agreement with an institutional investor in which we agreed to sell 5,434,783 shares of our common stock at a price of $9.20 per share. Net proceeds from this offering were approximately $50.0 million. In May 2020, we completed an underwritten public offering of 8,500,000 shares of our common stock (plus an underwriter option to purchase up to an additional 1,275,000 shares of common stock, which was exercised) at a price of $18 per share. Net proceeds from this offering, including the overallotment, were approximately $165.1 million, net of underwriting discounts and offering expenses of approximately $10.8 million. On December 17, 2020, we completed a public offering of 6,320,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 948,000 shares of common stock, which was exercised) at a price of $43.50 per share. Net proceeds from this offering, including the overallotment, were approximately $297.2 million after underwriting discounts and offering expenses of approximately $19.0 million. The 2019 WKSI Shelf is currently our only active shelf-registration statement. We may offer any combination of the securities registered under the 2019 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We believe that the 2019 WKSI Shelf provides us with the flexibility to raise additional capital to finance our operations as needed. Treasury Stock As of December 31, 2020 and 2019, 41,309 shares of common stock are being held in Treasury, at a cost of approximately $234,000, representing the fair market value on the date the shares were surrendered to the Company to satisfy employee tax obligations. Equity Incentive Plans The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (“2012 Incentive Plan”) was approved by stockholders in June 2020. Pursuant to this amendment, 8,000,000 shares were added to the 2012 Incentive Plan. As of December 31, 2020 and 2019, 2,526,166 and 2,605,730 options, respectively, were outstanding and up to an additional 4,054,913 shares may be issued under the 2012 Incentive Plan. Stock Options The estimated fair value of the options granted in the year ended December 31, 2020 was determined utilizing the Black-Scholes option-pricing model at the date of grant. The following table summarizes stock option activity for the years ended December 31, 2020 and 2019: Weighted- average Weighted- contractual Number of average term Aggregate shares exercise price (in years) intrinsic value Outstanding at December 31, 2018 1,916,900 — — $ — Granted 815,000 $ 6.50 Exercised — — Forfeited (126,170) — Expired — — Outstanding at December 31, 2019 2,605,730 $ 6.73 8.92 $ 11,706,110 Granted 75,000 8.21 Exercised (35,814) 4.10 Forfeited (118,750) 10.16 Expired — — Outstanding at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Vested and expected to vest at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Outstanding at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Expected to vest at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Exercisable at December 31, 2020 910,625 $ 6.23 8.13 $ 41,701,656 Total expense associated with the stock options was approximately $6.0 million, $3.5 million and zero during the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was approximately $1.7 million of total unrecognized compensation cost related to unvested time-based stock options, which is expected to be recognized over a weighted-average period of 1.0 year. As of December 31, 2020, the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based. Stock-based compensation for milestone-based options will be recorded if and when a milestone occurs. We recognized stock-based compensation expense of $3.8 million during the year ended December 31, 2020 for these stock options. The fair value of the Company’s option awards were estimated using the assumptions below: Year ended December 31, 2020 December 31, 2019 Volatility 186.91-191.05 % 172.99-291.61 % Expected term (in years) 5.0-6.25 5.0-6.25 Risk-free rate 0.34-0.54 % 1.82-2.49 % Expected dividend yield — % — % Restricted Stock Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted share activity for the years ended December 31, 2020, 2019 and 2018: Weighted-average grant date fair Number of shares value Outstanding at January 1, 2018 6,321,643 $ 7.17 Granted 1,562,211 13.07 Vested (1,596,966) 9.38 Forfeited (191,196) 8.13 Outstanding at December 31, 2018 6,095,692 8.07 Granted 1,851,520 12.95 Vested (738,960) 9.08 Forfeited (116,463) 7.96 Outstanding at December 31, 2019 7,091,789 7.78 Granted 4,909,829 20.34 Vested (1,087,918) 8.40 Forfeited (128,666) 8.70 Outstanding at December 31, 2020 10,785,034 $ 13.38 Total compensation expense associated with restricted stock grants was $74.2 million, $7.8 million and $12.9 million during the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was approximately $47.4 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 1 year. This amount does not include, as of December 31, 2020, 2,961,174 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 1,866,250 shares of restricted stock outstanding issued to non-employees. Milestone-based noncash compensation expense will be measured and recorded if and when a milestone becomes probable. Warrants The Company’s only outstanding warrant is the warrant issued to Hercules as part of our debt agreement to purchase 147,058 shares of common stock with an exercise price of $4.08. See Note 7 for further details. There was no expense related to warrants during the years ended December 31, 2020, 2019 and 2018. |
OTHER LIABILITIES
OTHER LIABILITIES | 12 Months Ended |
Dec. 31, 2020 | |
OTHER LIABILITIES | |
OTHER LIABILITIES | NOTE 6 – OTHER LIABILITIES The following is a summary of notes payable included in other current liabilities on the Company's consolidated balance sheets: (in thousands) December 31, 2020 December 31, 2019 Non- Non- Current current Current current portion, portion, portion, portion, net net Total net net Total Convertible 5% Notes Payable $ 938 $ — $ 938 $ 190 $ — $ 190 Totals $ 938 $ — $ 938 $ 190 $ — $ 190 Convertible 5% Notes Payable The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. We have no obligation under the 5% Notes aside from (a) 50% of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and (b) the conversion feature, discussed above. Interest accrues monthly, is added to principal on an annual basis, every March 8, and is payable at maturity, which was March 8, 2015 (see Note 4 for further details). The cumulative liability including accrued and unpaid interest of these notes was approximately $20.3 million at December 31, 2020 and $19.3 million at December 31, 2019. No payments have been made on the 5% Notes through December 31, 2020. In December 2011, we elected the fair value option for valuing the 5% Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments (see Note 4 for further details). Current Liabilities In 2018, we entered into an agreement with a contract manufacturer for the clinical and potential commercial supply of one of our product candidates. As part of this agreement, the contract manufacturer has agreed to defer payment of certain costs and expenses under the agreement in exchange for the payment of an administrative fee. To date we have incurred expenses related to this agreement of approximately $53.7 million as of December 31, 2020, which include service fees, raw material costs and administrative fees. We have made payments of $37.4 million to the contract manufacturer as of December 31, 2020. Accordingly, as of December 31, 2020 and 2019, $15.7 million and $47.2 million is included in current liabilities in the Company’s consolidated balance sheets. Of the remaining $15.7 million, $4.2 million is due in the first quarter of 2021. We will incur an administrative fee of six percent (6%) per year starting from the date of invoice issuance. For the years ended December 31, 2020, 2019 and 2018, we have accrued $1.2 million, $1.2 million and zero, respectively, in administrative fees in connection with these costs, which has been included in interest expense in the Company’s consolidated statements of operations. |
LONG-TERM DEBT
LONG-TERM DEBT | 12 Months Ended |
Dec. 31, 2020 | |
LONG-TERM DEBT. | |
LONG-TERM DEBT | NOTE 7 LONG-TERM DEBT On February 28, 2019 (the “Closing Date”), we entered into a term loan facility of up to $60.0 million (“Term Loan”) with Hercules, the proceeds of which were used for research and development programs and for general corporate purposes. The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the “Loan Agreement”), which provides for up to four separate advances. The first advance of $30.0 million was drawn on the Closing Date. Two additional advances of $10.0 million may be drawn at our option but subject to certain clinical trial milestones, and the fourth advance of $10.0 million, available in minimum increments of $5.0 million, is available through December 15, 2020 subject to the approval of Hercules’ investment committee. The Term Loan will mature on March 1, 2022 (the “Loan Maturity Date”). Each advance accrues interest at a per annum rate of interest equal to the greater of either (i) the “prime rate” as reported in The Wall Street Journal The Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. As of and through December 31, 2020, the Company has been in compliance with all covenants. The events of default under the Loan Agreement include, without limitation, and subject to customary grace periods, (1) our failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) our breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse effect, (4) a false or misleading representation or warranty in any material respect, (5) our insolvency or bankruptcy, (6) certain attachments or judgments on the Borrower’s assets, or (7) the occurrence of any material default under certain agreements or obligations involving indebtedness in excess of $750,000. If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement. The Loan Agreement also contains warrant coverage of 2% of the total amount funded. A warrant (the “Hercules Warrant”) was issued to Hercules to purchase 147,058 shares of common stock with an exercise price of $4.08. The Hercules Warrant is exercisable for seven years from the date of issuance. Hercules may exercise the Hercules Warrant either by (a) cash or check or (b) through a net issuance conversion. The shares will be registered and freely tradeable within six months of issuance. We accounted for the Hercules Warrant as an equity instrument since it was indexed to our common shares and met the criteria for classification in shareholders’ equity. The relative fair value of the Hercules Warrant on the date of issuance was approximately $1.0 million and was treated as debt issuance costs and as an offset to the Term Loan. This amount will be amortized to interest expense using the straight-line method, which approximates the effective interest method, over the life of the Term Loan. The Company estimated the fair value of the Hercules Warrant using the Black-Scholes model based on the following key assumptions: Exercise price $ 4.08 Common share price on date of issuance $ 6.80 Volatility 195.9 % Risk-free interest rate 2.63 % Expected dividend yield -- % Contractual term (in years) 7.00 years The Company incurred financing expenses of $2.8 million (including the fair value of the Hercules Warrant) related to the Hercules Loan Agreement which are recorded as debt issuance costs and as an offset to long-term debt on the Company’s consolidated balance sheet. The debt issuance costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and are included in interest expense in the Company’s consolidated statements of operations. Amortization of debt issuance costs was $0.9 million and $0.8 million for the years ended December 31, 2020 and 2019. At December 31, 2020 and 2019, the remaining unamortized balance of debt issuance costs was approximately $1.1 million and $2.0 million, respectively. Long-term debt as of December 31, 2020 and 2019, is as follows (in thousands): December 31, December 31, (in thousands) 2020 2019 Long-term debt $ 30,000 $ 30,000 End of term fee 975 975 30,975 30,975 Less: unamortized debt issuance costs (1,080) (2,005) 29,895 28,970 Less: current portion (22,179) — Long-term debt non-current $ 7,716 $ 28,970 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2020 | |
LEASES | |
LEASES | NOTE 8 LEASES In October 2014, we entered into an agreement (the “Office Agreement”) with Fortress Biotech, Inc. (“FBIO”) to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year The initial commitment period of the 45% rate was for a period of three (3) years. We and FBIO currently determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. As of December 31, 2020, the allocation rate is 65% and will be evaluated again in August 2021 for the following rent year. Also in connection with this lease, in October 2014 we pledged $0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. Additional collateral of $0.6 million was pledged in April 2018 to increase the letter of credit for the office space. In October 2019, we finalized a five-year lease for office space in New Jersey (the “NJ Lease”). We approximate an average annual rental obligation of $0.3 million under the NJ Lease. We took possession of this space in October 2019, with rental payments beginning in November 2019. The following components of lease expense are included in the Company’s consolidated statements of operations for the years ended December 31, 2020, 2019 and 2018: December 31, December 31, December 31, (in thousands) 2020 2019 2018 Operating lease cost $ 2,656 $ 2,651 $ 1,440 Net lease cost $ 2,656 $ 2,651 $ 1,440 As of December 31, 2020, the weighted-average remaining operating lease term was 7.7 years and the weighted-average discount rate for operating leases was 10.25%. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2020 was $2.0 million. The balance sheet classification of lease liabilities was as follows: December 31, December 31, (in thousands) 2020 2019 Liabilities Lease liability current portion $ 1,669 $ 1,616 Lease liability non-current 10,412 10,218 Total lease liability $ 12,081 $ 11,834 As of December 31, 2020, the maturities of lease liabilities were as follows: F” Operating (in thousands) leases 2021 $ 2,012 2022 2,035 2023 2,040 2024 1,923 2025 1,653 After 2025 9,884 Total lease payments 19,547 Less: interest (7,466) Present value of lease liabilities(*) $ 12,081 (*) As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date and considering the term of the lease to determine the present value of lease payments. We used the incremental borrowing rate of 10.25% on February 28, 2019, for operating leases that commenced prior to that date. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
INCOME. TAXES. | |
INCOME TAXES | NOTE 9 – INCOME TAXES We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. In determining the need for a valuation allowance, management reviews both positive and negative evidence, including current and historical results of operations, future income projections and the overall prospects of our business. Based upon management's assessment of all available evidence, we believe that it is more-likely-than-not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $276.7 million and $186.7 million as of December 31, 2020 and 2019, respectively. The CARES Act was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States. There are several provisions of the CARES Act that were considered in the December 31, 2020 year-end tax provision as follows. Under the CARES Act, a net operating loss carryforward (“NOL”) arising in tax years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five tax years preceding the tax year of such loss. The Company has incurred taxable losses in prior years; therefore, there is no carry-back opportunity to the Company. Under the Tax Cuts and Jobs Act of 2017 (“TCJA”), deductible interest expense was limited to 30% of adjusted taxable income. The CARES Act increased the limit to 50% of adjusted taxable income for 2019 and 2020 and allowed companies to elect to use 2019 adjusted taxable income for the 2020 limitation, if it resulted in more interest expense allowed. Due to the significant amount of taxable losses, this provision did not provide any benefit to the Company as all interest expense is disallowed (except as offset by interest income), even under the 50% limitation and using 2019 adjusted taxable income. The CARES Act allows employers to defer the deposit and payment of the employer’s share of Social Security taxes during the payroll tax deferral period of March 27, 2020 through December 31, 2020. The CARES Act provides for half of the deferred payroll taxes to be paid by December 31, 2021 and the second half to be paid by December 31, 2022. The Company did not participate in this deferral program. As of December 31, 2020, we have U.S. NOLs of approximately $956.3 million, research and development credit carryforwards (“R&D credits”) of approximately $27.6 million and business interest expense carryforwards of $7.5 million. For income tax purposes, these NOLs and R&D credits will expire in various amounts through 2037. NOLs generated after 2017 and the business interest expense carryforwards do not expire. The Tax Reform Act of 1986 contains provisions which limit the ability to utilize NOL carryforwards and R&D credit carryforwards in the case of certain events including significant changes in ownership interests. The Exchange Transaction with TG Bio may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Additionally, stock issuance activities may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Accordingly, a substantial portion of the Company’s NOLs above may be subject to annual limitations in reducing any future year’s taxable income, and a substantial portion of the R&D credit carryforwards may be subject to annual limitations in reducing any future year’s tax. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2020 and 2019 are presented below. (in thousands) 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 223,685 $ 158,177 Research and development credit 27,558 22,483 Noncash compensation 22,381 4,680 Disallowed interest 1,855 710 Other 1,224 661 Deferred tax asset, excluding valuation allowance 276,703 186,711 Less valuation allowance (276,703) (186,711) Net deferred tax assets $ — $ — There was no current or deferred For the year ended December 31, (in thousands) 2020 2019 2018 Loss before income taxes, as reported in the consolidated statements of operations $ (279,381) $ (172,871) $ (173,482) Computed “expected” tax benefit $ (58,670) $ (36,303) $ (36,431) Increase (decrease) in income taxes resulting from: Expected benefit from state and local taxes (10,801) (2,128) (2,243) Research and development credits (5,265) (7,266) (4,726) Other 1,065 641 639 Stock options (1,558) 1,292 (473) Enactment of federal tax reform (14,763) — — Change in the balance of the valuation allowance for deferred tax assets 89,992 43,764 43,234 $ — $ — $ — We file income tax returns in the U.S. federal and various state and local jurisdictions. With certain exceptions, the Company is no longer subject to U.S. federal and state income tax examinations by tax authorities for years prior to 2016. However, NOLs and tax credits generated from those prior years could still be adjusted upon audit. The Company would recognize interest and penalties, if any, to uncertain tax positions in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2020. We do not believe that there will be a material change in our unrecognized tax positions over the next twelve months. All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2020 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 10 – LICENSE AGREEMENTS TG-1101 (Ublituximab) In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong Pharmaceutical Co. Ltd. (“Ildong”) relating to the development and commercialization of ublituximab in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar. An upfront payment of $2.0 million, which was received in December 2012, net of $0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement. We recorded license revenue of approximately $152,000 for each of the years ended December 31, 2020, 2019 and 2018, and, at December 31, 2020 and 2019, have deferred revenue of approximately $0.8 million and $0.9 million, respectively, associated with this $2 million payment (approximately $152,000 of which has been classified in current liabilities at December 31, 2020 and 2019). We may receive up to an additional $5.0 million in payments upon the achievement of pre-specified milestones. In addition, upon commercialization, Ildong will make royalty payments to us on net sales of ublituximab in the sublicense territory. TGR-1202 (Umbralisib) On September 22, 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the “TGR-1202 License”) with Rhizen Pharmaceuticals, SA (“Rhizen”) for the development and commercialization of umbralisib. Prior to this, we had been jointly developing umbralisib in a 50:50 joint venture with Rhizen. Under the terms of the TGR-1202 License, Rhizen received a $4.0 million cash payment and 371,530 shares of our common stock as an upfront license fee. With respect to umbralisib, Rhizen is eligible to receive an aggregate of approximately $175 million in milestone payments, a small portion of which is attributable to the milestone paid upon the NDA filing for umbralisib and that will be payable based on the February 2021 FDA approval of umbralisib. The remainder of the milestone payments are payable on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if umbralisib is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product. Additionally, Rhizen will be entitled to tiered royalties on our future net sales of umbralisib and any New Product. In lieu of sales milestones and royalties on net sales, Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option. Rhizen will retain global manufacturing rights to umbralisib, provided that they are price competitive with alternative manufacturers. TG-1501: PDL1 (Cosibelimab) In March 2015, we entered into a Global Collaboration Agreement (“Collaboration Agreement”) with Checkpoint for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. The Collaboration Agreement was amended in June 2019 and upon execution of the amendment we incurred an upfront fee of $1.0 million. We incurred expenses of approximately $1.1 million, $4.1 million and $0.6 million for the years ended December 31, 2020, 2019 and 2018, respectively, the majority of which relates to manufacturing expenses and milestone payments of PD-L1. The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations. TG-1601: BET In May 2016, as part of a broader agreement with Jubilant Biosys (“Jubilant”), we entered into a sub-license agreement (“JBET Agreement”) with Checkpoint Therapeutics, Inc. (“Checkpoint”) (see Note 11), for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. Under the terms of the agreement, we paid Checkpoint an up-front licensing fee of $1.0 million and will make additional payments contingent on certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales. TG will also provide funding to support certain targeted research efforts at Jubilant. TG-1701: BTK In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co. (“Hengrui”), to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266). Pursuant to the agreement, in April 2018, we paid Hengrui an upfront fee of $1.0 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations. In addition, in July 2019, we paid Hengrui the first milestone of $0.1 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations. Hengrui is eligible to receive milestone payments totaling approximately $350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses. TG-1801: anti-CD47/anti-CD19 In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (“Novimmune”) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $3.0 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations. Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG-1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2020 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 11 – RELATED PARTY TRANSACTIONS LFB Biotechnologies On January 30, 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the “LFB License Agreement”). In connection with the LFB License Agreement, LFB Group was issued 5,000,000 shares of common stock, and a warrant to purchase 2,500,000 shares of common stock at a purchase price of $0.001 per share. Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. As of December 31, 2020 we accrued approximately $6.0 million in expense related to the achievement of certain milestones of the LFB License Agreement. These expenses are included in other research and development expenses in the accompanying consolidated statements of operations. As of December 31, 2020, we had approximately zero recorded in accounts payable related to the LFB License Agreement. Other Parties In October 2014, we entered into the Office Agreement with FBIO, to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year Under the Office Agreement, we agreed to pay FBIO our portion of the build-out costs, which have been allocated to us at the 45% rate mentioned above. The allocated build-out costs have been recorded in Leasehold Interest, net on the Company's consolidated balance sheets and will be amortized over the 15-year 3 In July 2015, we entered into a Shared Services Agreement (the “Shared Services Agreement”) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $0.8 million, $0.9 million and $1.6 million for shared services for the years ended December 31, 2020, 2019 and 2018, respectively, primarily related to shared personnel. In May 2016, as part of a broader agreement with Jubilant, we entered into a sublicense agreement with Checkpoint, a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paid Checkpoint an up-front licensing fee of $1.0 million in July 2016 and incurred expenses of $0.2 million in March 2017 for the first milestone achievement as part of the JBET Agreement which is recorded in other research and development in the accompanying consolidated statement of operations. In March 2015, we entered into the Collaboration Agreement with Checkpoint for the development and commercialization of anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. The Collaboration Agreement was amended in June 2019 and upon execution of the amendment we incurred an upfront fee of $1.0 million. We incurred expenses of approximately $1.1 million, $4.1 million and $0.6 million for the years ended December 31, 2020, 2019 and 2018, respectively, the majority of which relates to manufacturing expenses and milestone expenses PD-L1. The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | NOTE 12 – COMMITMENTS AND CONTINGENCIES As of December 31, 2020, we have known contractual obligations; commitments and contingencies of $65.2 million related to our short- and long-term liabilities and operating lease obligations. Less than More than Payment due by period (in thousands) Total 1 year 1-3 years 3-5 years 5 years Contractual obligations Operating leases $ 19,548 $ 2,012 $ 4,075 $ 3,577 $ 9,884 Long-term debt 30,000 22,179 7,821 — — Contract manufacturer 15,669 15,669 — — — Total $ 65,217 $ 39,860 $ 11,896 $ 3,577 $ 9,884 Contract Manufacturer See Note 6 for a detailed description of our current liabilities. Future minimum contractual commitments as of December 31, 2020 total approximately $15.7 million and are due in 2021. Leases See Note 8 for a detailed description of our lease arrangements in New York and New Jersey. Total rental expense was approximately $2.7 million, $2.7 million and $1.4 million for the years ended December 31, 2020, 2019, and 2018, respectively. Future minimum lease commitments as of December 31, 2020, in the aggregate total approximately $19.5 million through December 31, 2031. The preceding table shows future minimum lease commitments, which include our office leases in New York, New Jersey, North Carolina and Tennessee by year as of December 31, 2020. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Description of Business | DESCRIPTION OF BUSINESS |
Liquidity and Capital Resources | LIQUIDITY AND CAPITAL RESOURCES We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never become profitable. As of December 31, 2020, we have an accumulated deficit of $980.6 million. Our major sources of cash have been proceeds from the private placement and public offering of equity securities, and in 2019 from our loan and security agreement executed with Hercules Capital, Inc. (“Hercules”) (see Note 7 for more information). As of December 31, 2020 we had not yet generated revenue from drug sales of UKONIQ. UKONIQ first became commercially available in the United States in February of 2021. Even with the commercialization of UKONIQ and the future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. As of December 31, 2020, we had $605.4 million in cash and cash equivalents, and investment securities. We anticipate that our cash and cash equivalents, and investment securities as of December 31, 2020 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K , during which time the Company plans to continue to commercialize UKONIQ in the United States, which commenced in February 2021. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates. We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates. Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.” |
Recently Issued Accounting Standards | RECENTLY ISSUED ACCOUNTING STANDARDS In July 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2018-11, Leases - Targeted Improvements Leases ASU 2018-11 provides an entity with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new lease standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new lease standard will continue to be in accordance with Accounting Standards Codification (“ASC”) ASC 840, Leases ASU 2018-11 is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlier adoption permitted. The Company adopted ASU 2018-11 on January 1, 2019 using a modified retrospective method and will not restate comparative periods. We elected the package of practical expedients permitted under the transition guidance, which allows us to carry forward our historical lease classification and our assessment on whether a contract is or contains a lease. The adoption of this guidance resulted in the addition of material balances of ROU assets and lease liabilities to our consolidated balance sheets at January 1, 2019, primarily relating to our lease of office space (see Note 8). The impact to our consolidated statements of operations was not material as a result of this standard. In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting Compensation – Stock Compensation ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted ASU 2018-07 on January 1, 2019. The adoption of ASU 2018-07 did not have a material effect on our consolidated financial statements as of January 1, 2019. The adoption of ASU 2018-07 had no impact on nonemployee performance awards as they are measured based on the outcome that is probable. Other pronouncements issued by the FASB or other authoritative accounting standards with future effective dates are either not applicable or not significant to our consolidated financial statements. |
Use of Estimates | USE OF ESTIMATES The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued clinical trial expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements. |
Cash and Cash Equivalents | CASH AND CASH EQUIVALENTS We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents. |
Restricted Cash | RESTRICTED CASH We record cash pledged or held in trust as restricted cash. As of December 31, 2020 and 2019, we have approximately $1.3 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 8). |
Investment Securities | INVESTMENT SECURITIES Investment securities at both December 31, 2020 and 2019 consist of short-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Dividend and interest income are recognized when earned. |
Credit Risk | CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents and short-term investments with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits. |
Revenue Recognition | REVENUE RECOGNITION Effective January 1, 2018, the Company began recognizing revenue under ASC Topic 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. |
Research and Development Costs | RESEARCH AND DEVELOPMENT COSTS Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of certain costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period for expenses that are not explicitly defined by contractual rates and terms. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site costs, the financial terms of these agreements are subject to an initial negotiation and vary from contract to contract. Payments under these contracts may be uneven, and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. As such, certain expense accruals related to clinical site costs are recognized based on our estimate of the degree of performance of the event or events specified in the specific clinical study or trial contract. Prepaid research and development in our consolidated balance sheets includes, among other things, costs related to agreements with CROs, certain costs to third-party service providers related to development and manufacturing services as well as clinical development. These agreements often require payments in advance of services performed or goods received. Accordingly, as of December 31, 2020 and December 31, 2019, we recorded approximately $5.2 million and $8.1 million, respectively, in prepaid research and development related to such advance agreements. |
Income Taxes | INCOME TAXES Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created. We, and our subsidiaries, file income tax returns in the U.S. federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 9 for further information on impact of tax reform. The Coronavirus Aid, Relief, and Economic Security Act of 2020 (“CARES Act”) was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States. There are several provisions of the CARES Act that were considered in the December 31, 2020 year-end tax provision. However, the Company chose not to utilize any provisions or participate in certain programs due to lack of a benefit to the Company. |
Stock-Based Compensation | STOCK-BASED COMPENSATION We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements based on the fair values of such payments. Stock-based compensation expense recognized each period is based on the value of the portion of stock-based payment awards that is ultimately expected to vest during the period. Forfeitures are recognized as they occur. In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable. |
Basic and Diluted Net Loss Per Common Share | BASIC AND DILUTED NET LOSS PER COMMON SHARE Basic net loss per share of our common stock is calculated by dividing net loss applicable to the common stock by the weighted-average number of our common stock outstanding for the period. Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentially dilutive securities excluded from the calculation were 11,976,276, 8,361,739 and 6,528,932 at December 31, 2020, 2019 and 2018, respectively. During the years ended December 31, 2020, 2019 and 2018, the Company incurred a net loss; therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share. December 31, 2020 2019 2018 Unvested restricted stock 9,285,020 5,591,786 4,595,689 Options 2,526,166 2,605,730 1,916,900 Warrants 147,058 147,058 — Shares issuable upon note conversion 18,032 17,165 16,343 Total 11,976,276 8,361,739 6,528,932 |
Long-Lived Assets and Goodwill | LONG-LIVED ASSETS AND GOODWILL Long-lived assets are reviewed for potential impairment when circumstances indicate that the carrying value of long-lived tangible and intangible assets with finite lives may not be recoverable. Management’s policy in determining whether an impairment indicator exists, a triggering event, comprises measurable operating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions in determining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized. Goodwill is reviewed for impairment annually, or earlier when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process. The first step compares the fair value of the reporting unit with the unit’s carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. There was no impairment to goodwill as of December 31, 2020. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | December 31, 2020 2019 2018 Unvested restricted stock 9,285,020 5,591,786 4,595,689 Options 2,526,166 2,605,730 1,916,900 Warrants 147,058 147,058 — Shares issuable upon note conversion 18,032 17,165 16,343 Total 11,976,276 8,361,739 6,528,932 |
CASH AND CASH EQUIVALENTS (Tabl
CASH AND CASH EQUIVALENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
CASH. AND CASH EQUIVALENTS | |
Schedule of Cash and Cash Equivalents | The following tables summarize our cash and cash equivalents at December 31, 2020 and 2019: December 31, December 31, (in thousands) 2020 2019 Checking and bank deposits $ 399,879 $ 110,135 Money market funds 153,560 2,502 Total $ 553,439 $ 112,637 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INVESTMENT SECURITIES | |
Schedule of held-to-maturity securities | The following tables summarize our investment securities at December 31, 2020 and 2019: December 31, 2020 Amortized Gross Gross cost, as unrealized unrealized Estimated fair adjusted holding gains holding losses value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2021 and December 2021) (held-to-maturity) $ 51,987 $ 1 $ 4 $ 51,984 Total short-term investment securities $ 51,987 $ 1 $ 4 $ 51,984 December 31, 2019 Amortized Gross Gross cost, as unrealized unrealized Estimated fair adjusted holding gains holding losses value Short-term investments: Obligations of domestic governmental agencies (maturing between January 2020 and September 2020) (held-to-maturity) $ 27,798 $ 28 $ — $ 27,826 Total short-term investment securities $ 27,798 $ 28 $ — $ 27,826 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
FAIR VALUE MEASUREMENTS | |
Schedule of fair value, liabilities measured on recurring and nonrecurring basis | The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2020 and 2019: Financial liabilities at fair value as of December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 938 $ 938 Total $ — $ — $ 938 $ 938 Financial liabilities at fair value as of December 31, 2019 Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 190 $ 190 Total $ — $ — $ 190 $ 190 |
Schedule of change in level three fair value during period | The following table summarizes the changes in Level 3 instruments for the years ended December 31, 2019 and 2020: (in thousands) Balance at January 1, 2019 $ 67 Interest accrued on face value of 5% Notes 924 Conversion of 5% Notes — Change in fair value of Level 3 liabilities (801) Balance at December 31, 2019 190 Interest accrued on face value of 5% Notes 976 Conversion of 5% Notes — Change in fair value of Level 3 liabilities (228) Balance at December 31, 2020 $ 938 |
STOCKHOLDERS' (DEFICIT) EQUITY
STOCKHOLDERS' (DEFICIT) EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
STOCKHOLDERS' EQUITY | |
Schedule of Stock Options Activity | Weighted- average Weighted- contractual Number of average term Aggregate shares exercise price (in years) intrinsic value Outstanding at December 31, 2018 1,916,900 — — $ — Granted 815,000 $ 6.50 Exercised — — Forfeited (126,170) — Expired — — Outstanding at December 31, 2019 2,605,730 $ 6.73 8.92 $ 11,706,110 Granted 75,000 8.21 Exercised (35,814) 4.10 Forfeited (118,750) 10.16 Expired — — Outstanding at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Vested and expected to vest at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Outstanding at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Expected to vest at December 31, 2020 2,526,166 $ 6.99 8.10 $ 115,472,832 Exercisable at December 31, 2020 910,625 $ 6.23 8.13 $ 41,701,656 |
Schedule of Fair Value Assumptions | Year ended December 31, 2020 December 31, 2019 Volatility 186.91-191.05 % 172.99-291.61 % Expected term (in years) 5.0-6.25 5.0-6.25 Risk-free rate 0.34-0.54 % 1.82-2.49 % Expected dividend yield — % — % |
Schedule of Nonvested Restricted Stock Units Activity | Weighted-average grant date fair Number of shares value Outstanding at January 1, 2018 6,321,643 $ 7.17 Granted 1,562,211 13.07 Vested (1,596,966) 9.38 Forfeited (191,196) 8.13 Outstanding at December 31, 2018 6,095,692 8.07 Granted 1,851,520 12.95 Vested (738,960) 9.08 Forfeited (116,463) 7.96 Outstanding at December 31, 2019 7,091,789 7.78 Granted 4,909,829 20.34 Vested (1,087,918) 8.40 Forfeited (128,666) 8.70 Outstanding at December 31, 2020 10,785,034 $ 13.38 |
OTHER LIABILITIES (Tables)
OTHER LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
OTHER LIABILITIES | |
Schedule of Debt | The following is a summary of notes payable included in other current liabilities on the Company's consolidated balance sheets: (in thousands) December 31, 2020 December 31, 2019 Non- Non- Current current Current current portion, portion, portion, portion, net net Total net net Total Convertible 5% Notes Payable $ 938 $ — $ 938 $ 190 $ — $ 190 Totals $ 938 $ — $ 938 $ 190 $ — $ 190 |
LONG-TERM DEBT (Tables)
LONG-TERM DEBT (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
LONG-TERM DEBT. | |
Schedule of key assumptions | The Company estimated the fair value of the Hercules Warrant using the Black-Scholes model based on the following key assumptions: Exercise price $ 4.08 Common share price on date of issuance $ 6.80 Volatility 195.9 % Risk-free interest rate 2.63 % Expected dividend yield -- % Contractual term (in years) 7.00 years |
Schedule of long-term debt | Long-term debt as of December 31, 2020 and 2019, is as follows (in thousands): December 31, December 31, (in thousands) 2020 2019 Long-term debt $ 30,000 $ 30,000 End of term fee 975 975 30,975 30,975 Less: unamortized debt issuance costs (1,080) (2,005) 29,895 28,970 Less: current portion (22,179) — Long-term debt non-current $ 7,716 $ 28,970 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
LEASES | |
Schedule of lease cost | The following components of lease expense are included in the Company’s consolidated statements of operations for the years ended December 31, 2020, 2019 and 2018: December 31, December 31, December 31, (in thousands) 2020 2019 2018 Operating lease cost $ 2,656 $ 2,651 $ 1,440 Net lease cost $ 2,656 $ 2,651 $ 1,440 |
Schedule of classification of lease liabilities | The balance sheet classification of lease liabilities was as follows: December 31, December 31, (in thousands) 2020 2019 Liabilities Lease liability current portion $ 1,669 $ 1,616 Lease liability non-current 10,412 10,218 Total lease liability $ 12,081 $ 11,834 |
Schedule of lease liability maturity | As of December 31, 2020, the maturities of lease liabilities were as follows: F” Operating (in thousands) leases 2021 $ 2,012 2022 2,035 2023 2,040 2024 1,923 2025 1,653 After 2025 9,884 Total lease payments 19,547 Less: interest (7,466) Present value of lease liabilities(*) $ 12,081 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
INCOME. TAXES. | |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2020 and 2019 are presented below. (in thousands) 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 223,685 $ 158,177 Research and development credit 27,558 22,483 Noncash compensation 22,381 4,680 Disallowed interest 1,855 710 Other 1,224 661 Deferred tax asset, excluding valuation allowance 276,703 186,711 Less valuation allowance (276,703) (186,711) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | There was no current or deferred For the year ended December 31, (in thousands) 2020 2019 2018 Loss before income taxes, as reported in the consolidated statements of operations $ (279,381) $ (172,871) $ (173,482) Computed “expected” tax benefit $ (58,670) $ (36,303) $ (36,431) Increase (decrease) in income taxes resulting from: Expected benefit from state and local taxes (10,801) (2,128) (2,243) Research and development credits (5,265) (7,266) (4,726) Other 1,065 641 639 Stock options (1,558) 1,292 (473) Enactment of federal tax reform (14,763) — — Change in the balance of the valuation allowance for deferred tax assets 89,992 43,764 43,234 $ — $ — $ — |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of Loss Contingencies by Contingency | As of December 31, 2020, we have known contractual obligations; commitments and contingencies of $65.2 million related to our short- and long-term liabilities and operating lease obligations. Less than More than Payment due by period (in thousands) Total 1 year 1-3 years 3-5 years 5 years Contractual obligations Operating leases $ 19,548 $ 2,012 $ 4,075 $ 3,577 $ 9,884 Long-term debt 30,000 22,179 7,821 — — Contract manufacturer 15,669 15,669 — — — Total $ 65,217 $ 39,860 $ 11,896 $ 3,577 $ 9,884 |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Accumulated deficit | $ 980,597 | $ 701,216 |
Cash and cash equivalents, and investment securities | 605,400 | |
Restricted cash pledge | 1,300 | 1,300 |
Prepaid research and development | 5,231 | $ 8,105 |
Impairment to goodwill | $ 0 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Computation of diluted loss per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation | 11,976,276 | 8,361,739 | 6,528,932 |
Unvested Restricted Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation | 9,285,020 | 5,591,786 | 4,595,689 |
Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation | 2,526,166 | 2,605,730 | 1,916,900 |
Warrant [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation | 147,058 | 147,058 | 0 |
Share Issuable Upon Note Conversion [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities excluded from calculation | 18,032 | 17,165 | 16,343 |
CASH AND CASH EQUIVALENTS - Sum
CASH AND CASH EQUIVALENTS - Summary of cash and cash equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
CASH. AND CASH EQUIVALENTS | |||
Checking and bank deposits | $ 399,879 | $ 110,135 | |
Money market funds | 153,560 | 2,502 | |
Total | $ 553,439 | $ 112,637 | $ 41,958 |
INVESTMENT SECURITIES - Summary
INVESTMENT SECURITIES - Summary of investment securities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Amortized cost, as adjusted | $ 51,987 | $ 27,798 |
Gross unrealized holding gains | 1 | 28 |
Gross unrealized holding losses | 4 | |
Estimated fair value | 51,984 | 27,826 |
Short-term Investments [Member] | Obligations of domestic governmental agencies [Member] | ||
Amortized cost, as adjusted | 51,987 | 27,798 |
Gross unrealized holding gains | 1 | 28 |
Gross unrealized holding losses | 4 | |
Estimated fair value | $ 51,984 | $ 27,826 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2010USD ($)$ / shares | Dec. 31, 2020USD ($)itempayment | Dec. 31, 2019USD ($)item | |
Fair Value Measurement [Line Items] | |||
Cumulative liability | $ 20.3 | $ 19.3 | |
Manhattan and Ariston Pharmaceuticals Merger [Member] | |||
Fair Value Measurement [Line Items] | |||
Notes Issued | $ 15.5 | ||
Debt instrument, term | 5 years | ||
Det instrument rate | 5.00% | ||
Debt Instrument convertible conversion price | $ / shares | $ 1,125 | ||
Percentage of cash proceeds from operation to repay convertible debt | 50.00% | ||
Convertible Notes Payable [Member] | |||
Fair Value Measurement [Line Items] | |||
Det instrument rate | 5.00% | 5.00% | 5.00% |
Debt Instrument convertible conversion price | $ / shares | $ 1,125 | ||
Percentage of cash proceeds from operation to repay convertible debt | 50.00% | ||
Number of obligations | item | 0 | 0 | |
Cumulative liability | $ 20.3 | $ 19.3 | |
Number of payments | payment | 0 |
FAIR VALUE MEASUREMENTS - Finan
FAIR VALUE MEASUREMENTS - Financial liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 938 | $ 190 |
Totals | 938 | 190 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 0 | 0 |
Totals | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 0 | 0 |
Totals | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | 938 | 190 |
Totals | $ 938 | $ 190 |
FAIR VALUE MEASUREMENTS - Summa
FAIR VALUE MEASUREMENTS - Summary of changes in Level 3 instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
FAIR VALUE MEASUREMENTS | ||
Balance at beginning of period | $ 190 | $ 67 |
Interest accrued on face value of 5% Notes | 976 | 924 |
Conversion of 5% Notes | 0 | 0 |
Change in fair value of Level 3 liabilities | (228) | (801) |
Balance at end of period | $ 938 | $ 190 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 17, 2020 | Dec. 22, 2019 | Mar. 01, 2019 | Jul. 28, 2014 | Jul. 18, 2014 | Jun. 30, 2020 | May 31, 2020 | May 31, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 05, 2019 | Dec. 31, 2017 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||||||||
Number of rights for each outstanding share of common stock | 1 | ||||||||||||
Warrant purchase price | $ 100 | ||||||||||||
Warrants issued | 0.001 | ||||||||||||
Number of days after which right become exercisable | 10 days | ||||||||||||
Number of years before Rights will expire | 10 years | ||||||||||||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | |||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||||||||
Percent of commission rate | 3.00% | ||||||||||||
Shares sold | 5,434,783 | ||||||||||||
Share price in offering | $ 9.20 | ||||||||||||
Proceeds from offering | $ 50,000 | ||||||||||||
Treasury stock, shares | 41,309 | 41,309 | |||||||||||
Treasury stock issued | $ 234 | $ 234 | |||||||||||
Restricted stock outstanding | 1,866,250 | ||||||||||||
Expenses on stock options | $ 80,289 | $ 11,335 | $ 12,886 | ||||||||||
Expenses related to warrants | 147,058 | ||||||||||||
Maximum [Member] | |||||||||||||
Proceeds from offering | $ 300,000 | ||||||||||||
Warrant [Member] | |||||||||||||
Warrant purchase price | $ 4.08 | ||||||||||||
Warrants issued | 147,058 | ||||||||||||
Weighted average exercise price of warrants | $ 4.08 | ||||||||||||
Expenses related to warrants | 0 | 0 | 0 | ||||||||||
Unvested Restricted Stock [Member] | |||||||||||||
Restricted stock outstanding | 10,785,034 | 7,091,789 | 6,095,692 | 6,321,643 | |||||||||
Expenses on stock options | $ 74,200 | $ 7,800 | $ 12,900 | ||||||||||
Total unrecognized compensation expense related to unvested time-based restricted stock | $ 47,400 | ||||||||||||
Weighted-average period of recognition for total unrecognized compensation expense related to unvested time-based restricted stock | 1 year | ||||||||||||
Employee Stock Option [Member] | |||||||||||||
Expenses on stock options | $ 6,000 | $ 3,500 | $ 0 | ||||||||||
Total unrecognized compensation expense related to unvested time-based restricted stock | $ 1,700 | ||||||||||||
Weighted-average period of recognition for total unrecognized compensation expense related to unvested time-based restricted stock | 1 year | ||||||||||||
Recognized stock based compensation expense | $ 3,800 | ||||||||||||
Milestone Based Restricted Stock [Member] | |||||||||||||
Restricted stock outstanding | 2,961,174 | ||||||||||||
2017 ATM [Member] | |||||||||||||
Shares sold | 13,620,165 | 9,025,222 | |||||||||||
Gross proceeds | $ 99,300 | $ 115,800 | |||||||||||
Share price in offering | $ 7.29 | $ 12.83 | |||||||||||
Proceeds from offering | $ 97,500 | ||||||||||||
Proceeds from offering | $ 113,700 | ||||||||||||
2020 ATM [Member] | |||||||||||||
Percent of commission rate | 3.00% | ||||||||||||
Shares sold | 8,528,286 | ||||||||||||
Gross proceeds | $ 187,500 | ||||||||||||
Share price in offering | $ 21.99 | ||||||||||||
Proceeds from offering | $ 184,200 | ||||||||||||
2021 ATM [Member] | |||||||||||||
Shares sold | 804,100 | ||||||||||||
Gross proceeds | $ 33,900 | ||||||||||||
Share price in offering | $ 42.18 | ||||||||||||
Proceeds from offering | $ 33,300 | ||||||||||||
Underwritten Public Offering [Member] | |||||||||||||
Shares issued | 6,320,000 | 4,100,000 | 8,500,000 | ||||||||||
Share Price | $ 43.50 | $ 5.87 | $ 18 | ||||||||||
Proceeds from offering | $ 297,200 | $ 27,500 | $ 165,100 | ||||||||||
Payments of underwriting discounts and offering expenses | $ 19,000 | $ 200 | $ 10,800 | ||||||||||
Over-Allotment Option [Member] | |||||||||||||
Shares issued | 948,000 | 615,000 | 1,275,000 | ||||||||||
Period of underwriter overallotment option | 30 days | 30 days | |||||||||||
Series A Preferred Stock [Member] | |||||||||||||
Warrants issued | 0.001 | ||||||||||||
Amended and Restated 2012 Incentive Plan [Member] | Employee Stock Option [Member] | |||||||||||||
Number of shares added to the plan | 8,000,000 | ||||||||||||
Restricted stock outstanding | 2,526,166 | ||||||||||||
Options outstanding | 2,605,730 | ||||||||||||
Number of additional shares that may be issued | 4,054,913 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Equity Incentive Plans Stock Option Activity [Line Items] | ||
Number of shares, Outstanding Beginning Balance | 2,605,730 | 1,916,900 |
Number of shares, Granted. | 75,000 | 815,000 |
Number of shares, Exercised | (35,814) | 0 |
Number of shares, Forfeited | (118,750) | (126,170) |
Number of shares, Expired | 0 | 0 |
Number of shares, Outstanding Ending Balance | 2,526,166 | 2,605,730 |
Number of shares, Expected to vest | 2,526,166 | |
Number of shares, Exercisable | 910,625 | |
Weighted - average exercise price, Outstanding Beginning Balance | $ 6.73 | $ 0 |
Weighted - average exercise price, Granted | 8.21 | 6.50 |
Weighted - average exercise price, Exercised | 4.10 | 0 |
Weighted - average exercise price, Forfeited | 10.16 | 0 |
Weighted - average exercise price, Expired | 0 | 0 |
Weighted - average exercise price, Outstanding Ending Balance | 6.99 | $ 6.73 |
Weighted - average exercise price, Expected to vest | 6.99 | |
Weighted - average exercise price, Exercisable | $ 6.23 | |
Weighted - average Contractual Term | 8 years 1 month 6 days | 8 years 11 months 1 day |
Weighted - average Contractual Term, Exercisable | 8 years 1 month 17 days | |
Weighted - average Contractual Term,Expected to vest | 8 years 1 month 6 days | |
Aggregate Intrinsic Value, Outstanding | $ 115,472,832 | $ 11,706,110 |
Aggregate Intrinsic Value, Expected to vest | 115,472,832 | |
Aggregate Intrinsic Value, Exercisable | $ 41,701,656 |
STOCKHOLDERS' EQUITY - Fair val
STOCKHOLDERS' EQUITY - Fair value assumptions of options (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Minimum [Member] | ||
Volatility, minimum | 186.91% | 172.99% |
Expected term (in years) | 5 years | 5 years |
Risk-free rate, minimum | 0.34% | 1.82% |
Maximum [Member] | ||
Volatility, maximum | 191.05% | 291.61% |
Expected term (in years) | 6 years 3 months | 6 years 3 months |
Risk-free rate, maximum | 0.54% | 2.49% |
STOCKHOLDERS' EQUITY - Summary
STOCKHOLDERS' EQUITY - Summary of restricted shares (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Equity Incentive Plans Restricted Stock Activity [Line Items] | |||
Number of Shares, Outstanding at Ending Balance | 1,866,250 | ||
Unvested Restricted Stock [Member] | |||
Equity Incentive Plans Restricted Stock Activity [Line Items] | |||
Number of Shares, Outstanding at Beginning Balance | 7,091,789 | 6,095,692 | 6,321,643 |
Number of Shares, Granted | 4,909,829 | 1,851,520 | 1,562,211 |
Number of Shares, Vested | (1,087,918) | (738,960) | (1,596,966) |
Number of Shares, Forfeited | (128,666) | (116,463) | (191,196) |
Number of Shares, Outstanding at Ending Balance | 10,785,034 | 7,091,789 | 6,095,692 |
Weighted Average Grant Date Fair Value, Outstanding at Beginning Balance | $ 7.78 | $ 8.07 | $ 7.17 |
Weighted Average Grant Date Fair Value, Granted | 20.34 | 12.95 | 13.07 |
Weighted Average Grant Date Fair Value, Vested | 8.40 | 9.08 | 9.38 |
Weighted Average Grant Date Fair Value, Forfeited | 8.70 | 7.96 | 8.13 |
Weighted Average Grant Date Fair Value, Outstanding at Ending Balance | $ 13.38 | $ 7.78 | $ 8.07 |
OTHER LIABILITIES - Notes payab
OTHER LIABILITIES - Notes payables in other current liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Notes payable, Current portion, net | $ 938 | $ 190 |
Notes Payable, Noncurrent, net | 0 | 0 |
Notes Payable. | 938 | 190 |
Convertible Notes [Member] | ||
Notes payable, Current portion, net | 938 | 190 |
Notes Payable, Noncurrent, net | 0 | 0 |
Notes Payable. | $ 938 | $ 190 |
OTHER LIABILITIES (Details)
OTHER LIABILITIES (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2010$ / shares | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($)itempayment | Dec. 31, 2019USD ($)item | Dec. 31, 2018USD ($) | |
Cumulative Liability | $ 20,300,000 | $ 19,300,000 | |||
Construction Contract Cost, Progress Payment Offset | 37,400,000 | ||||
Agreement total costs | 53,700,000 | ||||
Agreement costs included in current liabilities | $ 15,700,000 | 47,200,000 | |||
Percentage Of Administrative Fee | 6.00% | ||||
Interest Expenses | $ 1,200,000 | $ 1,200,000 | $ 0 | ||
Subsequent Event [Member] | |||||
Agreement costs included in current liabilities | $ 4,200,000 | ||||
Convertible Notes Payable [Member] | |||||
Det instrument rate | 5.00% | 5.00% | 5.00% | ||
Debt Instrument convertible conversion price | $ / shares | $ 1,125 | ||||
Percentage Of Cash Proceeds From Operation To Repay Convertible Debt | 50.00% | ||||
Cumulative Liability | $ 20,300,000 | $ 19,300,000 | |||
Construction Contract Cost, Progress Payment Offset | $ 0 | ||||
Number of obligations | item | 0 | 0 | |||
Number of payments | payment | 0 |
LONG-TERM DEBT (Details)
LONG-TERM DEBT (Details) $ in Thousands | Feb. 28, 2019USD ($)Dinstallmentloan |
Prime Rate [Member] | Minimum [Member] | |
Debt Instrument [Line Items] | |
Interest rate ( as a percent) | 4.75% |
Prime Rate [Member] | Maximum [Member] | |
Debt Instrument [Line Items] | |
Interest rate ( as a percent) | 10.25% |
Term Loan [Member] | |
Debt Instrument [Line Items] | |
Maximum term loan facility | $ 60,000 |
Amount drawn on first advance | $ 30,000 |
Number of additional advances | loan | 2 |
Additional Advances Drawn | $ 10,000 |
Debt Instrument, Fourth Advance Available | 10,000 |
Minimum incremental borrowings | 5,000 |
Minimum amount raised from unrestricted cash proceeds | $ 150,000 |
Number of amortization payments installments | installment | 18 |
Number of interest only payments installments | installment | 12 |
Number of business days | D | 7 |
Expected prepayment on outstanding advances | $ 5,000 |
Prepayment charge (as a percent) | 3.50% |
Interest on past due outstanding (as a percent) | 4.00% |
Minimum indebtedness by borrower in default | $ 750 |
Term Loan [Member] | Maximum [Member] | |
Debt Instrument [Line Items] | |
Number of advances | loan | 4 |
Term Loan [Member] | Within First twelve Months Of Closing Date [Member] | |
Debt Instrument [Line Items] | |
Prepayment charge (as a percent) | 3.00% |
Term Loan [Member] | After Twelve Months But On Or Before Twenty Four Months [Member] | |
Debt Instrument [Line Items] | |
Prepayment charge (as a percent) | 1.50% |
Term Loan [Member] | After Twenty Four Months Of Closing Date [Member] | |
Debt Instrument [Line Items] | |
Prepayment charge (as a percent) | 0.00% |
LONG-TERM DEBT - Warrants fair
LONG-TERM DEBT - Warrants fair value (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jul. 18, 2014 | |
Warrants issued | 0.001 | |||
Warrant purchase price | $ 100 | |||
Amortization of Debt Issuance Costs | $ 925 | $ 772 | $ 0 | |
Unamortized Debt Issuance Expense | $ 1,080 | 2,005 | ||
Warrant [Member] | ||||
Warrant coverage percentage | 2.00% | |||
Warrants issued | 147,058 | |||
Warrant purchase price | $ 4.08 | |||
Class Of Warrant Or Right Fair Value | $ 1,000 | |||
Warrant exercisable term | 7 years | |||
Financing expenses, Hercules Loan Agreement | $ 2,800 | |||
Amortization of Debt Issuance Costs | 900 | 800 | ||
Unamortized Debt Issuance Expense | $ 1,100 | $ 2,000 |
LONG-TERM DEBT - Estimated fair
LONG-TERM DEBT - Estimated fair value of warrants (Details) - Warrant [Member] | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Measurement Input, Exercise Price [Member] | |
Exercise Price | $ 4.08 |
Measurement Input, Share Price [Member] | |
Common share price on date of issuance | $ 6.80 |
Measurement Input, Price Volatility [Member] | |
Volatility | 195.90% |
Measurement Input, Risk Free Interest Rate [Member] | |
Risk-free interest rate | 2.63% |
Measurement Input, Expected Term [Member] | |
Contractual term (in years) | 7 years |
LONG-TERM DEBT - Summary (Detai
LONG-TERM DEBT - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
LONG-TERM DEBT. | ||
Long-term debt | $ 30,000 | $ 30,000 |
End of term fee | 975 | 975 |
Long-term debt, gross | 30,975 | 30,975 |
Less: unamortized debt issuance costs | (1,080) | (2,005) |
Long-term Debt | 29,895 | 28,970 |
Less: Current portion | (22,179) | 0 |
Long-term debt non-current | $ 7,716 | $ 28,970 |
LEASES (Details)
LEASES (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Oct. 31, 2019USD ($) | Oct. 31, 2014USD ($)ft² | Dec. 31, 2014 | Dec. 31, 2020USD ($)lease | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Feb. 28, 2019 | Jan. 01, 2019USD ($) | Apr. 30, 2018USD ($) | |
Rent expense | $ 2,700 | $ 2,700 | $ 1,400 | ||||||
Right-of-use-assets | 9,312 | 9,402 | |||||||
Operating Lease Liability | $ 12,081 | $ 11,834 | |||||||
ASU 2016-02 | Restatement Adjustment | |||||||||
Right-of-use-assets | $ 9,500 | ||||||||
Operating Lease Liability | 8,100 | ||||||||
Office Agreement [Member] | |||||||||
Percentage Of Occupancy | 45.00% | 45.00% | 65.00% | ||||||
Area of Land | ft² | 24,000 | ||||||||
Operating Lease Initial Commitment Period | 15 years | 15 years | |||||||
Average Annual Rental Payments | $ 1,100 | $ 1,400 | |||||||
Right-of-use-assets | 9,300 | 7,700 | |||||||
Operating Lease Liability | $ 12,100 | $ 9,300 | |||||||
Number of lease with renewal option | lease | 1 | ||||||||
Lease additional term | 2 years | ||||||||
Initial commitment period for office lease space | 3 years | ||||||||
Line of credit | $ 600 | ||||||||
Additional collateral pledged | $ 600 | ||||||||
Weighted-average discount rate for operating leases | 10.25% | 10.25% | |||||||
Weighted-average remaining operating lease term | 7 years 8 months 12 days | ||||||||
Operating Lease, Payments, Use | $ 2,000 | ||||||||
Office Agreement [Member] | Minimum [Member] | |||||||||
Remaining lease term | 4 months | ||||||||
Office Agreement [Member] | Maximum [Member] | |||||||||
Remaining lease term | 11 years | ||||||||
NJ Lease [Member] | |||||||||
Operating Lease Initial Commitment Period | 5 years | ||||||||
Average Annual Rental Payments | $ 300 |
LEASES - Components of lease ex
LEASES - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
LEASES | |||
Operating lease cost | $ 2,656 | $ 2,651 | $ 1,440 |
Net lease cost | $ 2,656 | $ 2,651 | $ 1,440 |
LEASES - Classification of leas
LEASES - Classification of lease liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
LEASES | ||
Lease liability current portion | $ 1,669 | $ 1,616 |
Lease liability non-current | 10,412 | 10,218 |
Total lease liability | $ 12,081 | $ 11,834 |
LEASES - Maturities of lease li
LEASES - Maturities of lease liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
LEASES | ||
2021 | $ 2,012 | |
2022 | 2,035 | |
2023 | 2,040 | |
2024 | 1,923 | |
2025 | 1,653 | |
After 2025 | 9,884 | |
Total lease payments | 19,547 | |
Less: Interest | (7,466) | |
Total lease liability | $ 12,081 | $ 11,834 |
INCOME TAXES - Summary of defer
INCOME TAXES - Summary of deferred tax assets and liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 223,685 | $ 158,177 |
Research and development credit | 27,558 | 22,483 |
Noncash compensation | 22,381 | 4,680 |
Disallowed interest | 1,855 | 710 |
Other | 1,224 | 661 |
Deferred tax asset, excluding valuation allowance | 276,703 | 186,711 |
Less valuation allowance | 276,703 | 186,711 |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES - Provision for in
INCOME TAXES - Provision for income taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
INCOME. TAXES. | |||
Loss before income taxes, as reported in the consolidated statements of operations | $ (279,381,000) | $ (172,871,000) | $ (173,482) |
Computed "expected" tax benefit | (58,670,000) | (36,303,000) | (36,431) |
Increase (decrease) in income taxes resulting from: | |||
Expected benefit from state and local taxes | (10,801,000) | (2,128,000) | (2,243) |
Research and development credits | (5,265,000) | (7,266,000) | (4,726) |
Other | 1,065,000 | 641,000 | 639 |
Stock awards | (1,558,000) | 1,292,000 | (473) |
Enactment of federal tax reform | (14,763,000) | 0 | 0 |
Change in the balance of the valuation allowance for deferred tax assets | 89,992,000 | 43,764,000 | 43,234 |
Income Tax Expense (Benefit) | $ 0 | $ 0 | $ 0 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Deferred Tax Assets And Liabilities [Line Items] | |||
Valuation allowance | $ 276,703,000 | $ 186,711,000 | |
Operating Loss Carryforwards | 956,300,000 | ||
Research and Development Carryforward | 27,600,000 | ||
Business Interest Expense Carryforward | 7,500,000 | ||
Current income tax expense | 0 | ||
Deferred income tax expense | 0 | ||
Accrual for interest and penalties related to uncertain tax positions | $ 0 | ||
Us Federal Income Tax [Member] | |||
Deferred Tax Assets And Liabilities [Line Items] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% | 21.00% |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Jul. 31, 2019 | Apr. 30, 2018 | May 31, 2016 | Mar. 31, 2015 | Dec. 31, 2012 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 30, 2012 | |
Income taxes | $ 0 | $ 0 | $ 0 | ||||||
Collaboration Agreement [Member] | |||||||||
Upfront fee | $ 1,000,000 | ||||||||
Manufacturing expense | 1,100,000 | 4,100,000 | 600,000 | ||||||
JBET Agreement [Member] | |||||||||
Upfront fee | 1,000,000 | ||||||||
Income taxes | 177,000,000 | ||||||||
TG-1101 [Member] | |||||||||
Upfront fee | $ 5,000,000 | $ 2,000,000 | |||||||
Income taxes | $ 300,000 | ||||||||
Term after first commercial sale | 15 years | ||||||||
Deferred Revenue | 800,000 | 900,000 | |||||||
Deferred Revenue, Current | 152,000 | $ 152,000 | $ 152,000 | ||||||
TG-1701 [Member] | |||||||||
Upfront fee | $ 100,000 | $ 1,000,000 | 350,000,000 | ||||||
TG-1801 [Member] | |||||||||
Upfront fee | $ 3,000,000 | ||||||||
Additional payments on achievement of certain milestones | $ 185,000,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | Jan. 30, 2012$ / sharesshares | Jun. 30, 2019USD ($) | Mar. 31, 2017USD ($) | Jul. 31, 2016USD ($) | Oct. 31, 2014USD ($)ft² | Dec. 31, 2014 | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Jan. 01, 2019USD ($) | Apr. 30, 2018USD ($) | Jul. 18, 2014$ / shares |
Related Party Transaction [Line Items] | ||||||||||||
Warrant purchase price | $ / shares | $ 100 | |||||||||||
Other Research and Development Expense | $ 151,934,000 | $ 148,269,000 | $ 149,793,000 | |||||||||
Operating Lease Liability | 12,081,000 | 11,834,000 | ||||||||||
Right-of-use-assets | 9,312,000 | 9,402,000 | ||||||||||
Lfb Group [Member] | LFB License Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Other Research and Development Expense | 6,000,000 | |||||||||||
Accounts payable related to LFB Biotechnologies | $ 0 | |||||||||||
LFB Biotechnologies [Member] | LFB License Agreement | Common Stock [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Commont stock issued | shares | 5,000,000 | |||||||||||
Warrants issued to purchase common stock | shares | 2,500,000 | |||||||||||
Warrant purchase price | $ / shares | $ 0.001 | |||||||||||
Office Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Percentage Of Occupancy | 45.00% | 45.00% | 65.00% | |||||||||
Area of leases office space | ft² | 24,000 | |||||||||||
Operating Lease Initial Commitment Period | 15 years | 15 years | ||||||||||
Average Annual Rental Payments | $ 1,100,000 | $ 1,400,000 | ||||||||||
Operating Lease Liability | 12,100,000 | $ 9,300,000 | ||||||||||
Right-of-use-assets | 9,300,000 | $ 7,700,000 | ||||||||||
Initial commitment period for office lease space | 3 years | |||||||||||
Long-term Line of Credit | $ 600,000 | |||||||||||
Additional collateral pledged | $ 600,000 | |||||||||||
Upfront licensing fee paid | $ 1,000,000 | |||||||||||
Expenses incurred | $ 200,000 | |||||||||||
Upfront fee | 1,100,000 | 4,100,000 | ||||||||||
Shared Services Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Costs and Expenses, Related Party | $ 800,000 | $ 900,000 | 1,600,000 | |||||||||
Collaboration Agreement [Member] | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Upfront fee | $ 1,000,000 | $ 600,000 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Contractual obligations (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Payment due by period, Contractual obligations, Less than 1 year | $ 39,860 |
Payment due by period, Contractual obligations, 1-3 years | 11,896 |
Payment due by period, Contractual obligations, 3-5 years | 3,577 |
Payment due by period, Contractual obligations, More than 5 years | 9,884 |
Payment due by period, Contractual obligations, Total | 65,217 |
Operating Leases [Member] | |
Payment due by period, Contractual obligations, Less than 1 year | 2,012 |
Payment due by period, Contractual obligations, 1-3 years | 4,075 |
Payment due by period, Contractual obligations, 3-5 years | 3,577 |
Payment due by period, Contractual obligations, More than 5 years | 9,884 |
Payment due by period, Contractual obligations, Total | 19,548 |
Long-term debt [Member] | |
Payment due by period, Contractual obligations, Less than 1 year | 22,179 |
Payment due by period, Contractual obligations, 1-3 years | 7,821 |
Payment due by period, Contractual obligations, 3-5 years | 0 |
Payment due by period, Contractual obligations, More than 5 years | 0 |
Payment due by period, Contractual obligations, Total | 30,000 |
Contract Manufacturer [Member] | |
Payment due by period, Contractual obligations, Less than 1 year | 15,669 |
Payment due by period, Contractual obligations, 1-3 years | 0 |
Payment due by period, Contractual obligations, 3-5 years | 0 |
Payment due by period, Contractual obligations, More than 5 years | 0 |
Payment due by period, Contractual obligations, Total | $ 15,669 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Lease, Expense | $ 2,700 | $ 2,700 | $ 1,400 |
Contractual obligation | 65,217 | ||
Contract Manufacturer [Member] | |||
Contractual obligation | 15,669 | ||
Operating Leases [Member] | |||
Contractual obligation | $ 19,548 |