Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 03, 2021 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-32639 | |
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 Street, 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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 142,943,139 | |
Entity Central Index Key | 0001001316 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 326,512 | $ 553,439 |
Short-term investment securities | 30,338 | 51,987 |
Accounts receivable, net | 1,384 | |
Prepaid research and development | 11,043 | 5,231 |
Other current assets | 2,502 | 1,083 |
Total current assets | 371,779 | 611,740 |
Restricted cash | 1,263 | 1,259 |
Long-term investment securities | 24,550 | |
Right of use assets | 8,804 | 9,312 |
Leasehold interest, net | 1,892 | 2,051 |
Equipment, net | 600 | 481 |
Goodwill | 799 | 799 |
Total assets | 409,687 | 625,642 |
Current liabilities: | ||
Accounts payable and accrued expenses | 44,702 | 37,014 |
Other current liabilities | 12,628 | 18,236 |
Loan payable - current portion | 15,999 | 22,179 |
Lease liability - current portion | 1,468 | 1,669 |
Accrued compensation | 12,858 | 8,456 |
Total current liabilities | 87,655 | 87,554 |
Deferred revenue, net of current portion | 495 | 610 |
Loan payable - non-current | 7,716 | |
Lease liability - non-current | 10,020 | 10,412 |
Total liabilities | 98,170 | 106,292 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value per share (175,000,000 shares authorized, 142,984,448 and 140,617,606 shares issued, 142,943,139 and 140,576,297 shares outstanding at September 30, 2021 and December 31, 2020, respectively) | 143 | 141 |
Additional paid-in capital | 1,546,967 | 1,500,040 |
Treasury stock, at cost, 41,309 shares at September 30, 2021 and December 31, 2020 | (234) | (234) |
Accumulated deficit | (1,235,359) | (980,597) |
Total stockholders' equity | 311,517 | 519,350 |
Total liabilities and stockholders' equity | $ 409,687 | $ 625,642 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 175,000,000 | 175,000,000 |
Common stock, shares issued | 142,984,448 | 140,617,606 |
Common stock, shares outstanding | 142,943,139 | 140,576,297 |
Treasury stock, shares | 41,309 | 41,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 2,030 | $ 38 | $ 4,368 | $ 114 |
Costs and expenses: | ||||
Cost of product revenue | 292 | 580 | ||
Research and development: | ||||
Noncash compensation | 4,534 | 4,618 | 19,061 | 8,150 |
Other research and development | 47,433 | 45,846 | 140,872 | 114,785 |
Total research and development | 51,967 | 50,464 | 159,933 | 122,935 |
Selling, general and administrative: | ||||
Noncash compensation | 9,463 | 23,712 | 27,857 | 38,618 |
Other selling, general and administrative | 25,436 | 11,584 | 67,821 | 25,373 |
Total selling, general and administrative | 34,899 | 35,296 | 95,678 | 63,991 |
Total costs and expenses | 87,158 | 85,760 | 256,191 | 186,926 |
Operating loss | (85,128) | (85,722) | (251,823) | (186,812) |
Other expense (income): | ||||
Interest expense | 1,038 | 1,610 | 4,559 | 5,038 |
Other income | (529) | (169) | (1,619) | (687) |
Total other expense (income), net | 509 | 1,441 | 2,940 | 4,351 |
Net loss | $ (85,637) | $ (87,163) | $ (254,763) | $ (191,163) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.65) | $ (0.73) | $ (1.93) | $ (1.70) |
Weighted average shares used in computing basic and diluted net loss per common share (in shares) | 132,353,119 | 119,176,336 | 132,109,912 | 112,380,784 |
Product revenue, net [Member] | ||||
Revenue: | ||||
Total revenue | $ 1,992 | $ 4,254 | ||
License revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 38 | $ 38 | $ 114 | $ 114 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Total |
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 | 80 | 80 | |||
Issuance of common stock in connection with exercise of options | 19,750 | ||||
Issuance of restricted stock | $ 1 | (1) | |||
Issuance of restricted stock (in shares) | 774,300 | ||||
Forfeiture of restricted stock (in shares) | (10,000) | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 11,068 | 11,068 | |||
Net loss | (51,116) | (51,116) | |||
Balance at Mar. 31, 2020 | $ 110 | 751,103 | $ (234) | (752,332) | (1,353) |
Balance (in shares) at Mar. 31, 2020 | 110,209,293 | 41,309 | |||
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 | |||
Net loss | (191,163) | ||||
Balance at Sep. 30, 2020 | $ 129 | 1,063,142 | $ (234) | (892,379) | 170,658 |
Balance (in shares) at Sep. 30, 2020 | 128,959,861 | 41,309 | |||
Balance at Mar. 31, 2020 | $ 110 | 751,103 | $ (234) | (752,332) | (1,353) |
Balance (in shares) at Mar. 31, 2020 | 110,209,293 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 16 | 16 | |||
Issuance of common stock in connection with exercise of options | 3,750 | ||||
Issuance of restricted stock | $ 2 | (2) | |||
Issuance of restricted stock (in shares) | 2,208,529 | ||||
Forfeiture of restricted stock (in shares) | (41,666) | ||||
Issuance of common stock in public offering | $ 10 | 165,032 | 165,042 | ||
Issuance of common stock in public offering (in shares) | 9,775,000 | ||||
Issuance of common stock in At-the-Market offerings (net of offering costs) | $ 5 | 76,031 | 76,036 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 4,535,608 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 7,370 | 7,370 | |||
Net loss | (52,884) | (52,884) | |||
Balance at Jun. 30, 2020 | $ 127 | 999,550 | $ (234) | (805,216) | 194,227 |
Balance (in shares) at Jun. 30, 2020 | 126,690,514 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 38 | 38 | |||
Issuance of common stock in connection with exercise of options | 9,347 | ||||
Issuance of restricted stock | $ 1 | (1) | |||
Issuance of restricted stock (in shares) | 915,000 | ||||
Forfeiture of restricted stock (in shares) | (65,000) | ||||
Offering costs paid | 10,900 | ||||
Issuance of common stock in public offering | (1) | (1) | |||
Issuance of common stock in At-the-Market offerings (net of offering costs) | $ 1 | 35,226 | 35,227 | ||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 1,410,000 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 28,330 | 28,330 | |||
Net loss | (87,163) | (87,163) | |||
Balance at Sep. 30, 2020 | $ 129 | 1,063,142 | $ (234) | (892,379) | 170,658 |
Balance (in shares) at Sep. 30, 2020 | 128,959,861 | 41,309 | |||
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 | |||
Issuance of common stock in connection with exercise of options | 128 | 128 | |||
Issuance of common stock in connection with exercise of options | 31,245 | ||||
Issuance of restricted stock | $ 1 | (1) | |||
Issuance of restricted stock (in shares) | 893,488 | ||||
Forfeiture of restricted stock (in shares) | (21,643) | ||||
Offering costs paid | (183) | (183) | |||
Compensation in respect of restricted stock granted to employees, directors and consultants | 16,618 | 16,618 | |||
Net loss | (90,628) | (90,628) | |||
Balance at Mar. 31, 2021 | $ 142 | 1,516,602 | $ (234) | (1,071,225) | 445,285 |
Balance (in shares) at Mar. 31, 2021 | 141,520,696 | 41,309 | |||
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 | |||
Net loss | (254,763) | ||||
Balance at Sep. 30, 2021 | $ 143 | 1,546,967 | $ (234) | (1,235,359) | 311,517 |
Balance (in shares) at Sep. 30, 2021 | 142,984,448 | 41,309 | |||
Balance at Mar. 31, 2021 | $ 142 | 1,516,602 | $ (234) | (1,071,225) | 445,285 |
Balance (in shares) at Mar. 31, 2021 | 141,520,696 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 38 | 38 | |||
Issuance of common stock in connection with exercise of options | (9,364) | ||||
Issuance of restricted stock | $ 1 | (1) | |||
Issuance of restricted stock (in shares) | 1,356,151 | ||||
Forfeiture of restricted stock (in shares) | (12,416) | ||||
Offering costs paid | 10,900 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 16,304 | 16,304 | |||
Net loss | (78,497) | (78,497) | |||
Balance at Jun. 30, 2021 | $ 143 | 1,532,943 | $ (234) | (1,149,722) | 383,130 |
Balance (in shares) at Jun. 30, 2021 | 142,873,795 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 50 | 50 | |||
Issuance of common stock in connection with exercise of options | (12,085) | ||||
Forfeiture of restricted stock (in shares) | (115,655) | ||||
Offering costs paid | (22) | (22) | |||
Issuance of common stock in At-the-Market offerings (net of offering costs) (in shares) | 214,223 | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 13,996 | 13,996 | |||
Net loss | (85,637) | (85,637) | |||
Balance at Sep. 30, 2021 | $ 143 | $ 1,546,967 | $ (234) | $ (1,235,359) | $ 311,517 |
Balance (in shares) at Sep. 30, 2021 | 142,984,448 | 41,309 |
Consolidated Statements of Equi
Consolidated Statements of Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | ||
Jun. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | |
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity | |||
Offering costs | $ 10,900 | $ 10,900 | |
Offering costs, at market | $ 1,400 | $ 2,000 | $ 500 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (254,763) | $ (191,163) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Noncash stock compensation expense | 46,918 | 46,768 |
Depreciation and amortization | 202 | 105 |
Amortization of premium on investment securities | 421 | |
Amortization of premium on investment securities | (75) | |
Amortization of debt issuance costs | 694 | 694 |
Amortization of leasehold interest | 159 | 163 |
Noncash change in lease liability and right of use asset | 1,422 | 1,364 |
Change in fair value of notes payable | (315) | 286 |
Changes in assets and liabilities: | ||
(Increase) decrease in other current assets | (7,255) | 2,503 |
Increase in accounts receivable | (1,384) | |
Increase (decrease) in accounts payable and accrued expenses | 12,090 | 5,893 |
Decrease in lease liabilities | (1,507) | (1,360) |
Decrease in other liabilities | (5,293) | (27,545) |
Decrease in deferred revenue | (114) | (114) |
Net cash used in operating activities | (208,725) | (162,481) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from maturity of short-term securities | 40,000 | 35,250 |
Investment in held-to-maturity securities | (43,299) | (7,482) |
Purchases of equipment | (321) | (202) |
Net cash (used in) provided by investing activities | (3,620) | 27,566 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Payment of loan payable | (14,590) | |
Proceeds from sale of common stock, net | 276,303 | |
Proceeds from exercise of options | 216 | 135 |
Offering costs paid | (204) | |
Net cash (used in) provided by financing activities | (14,578) | 276,438 |
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (226,923) | 141,523 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 554,698 | 113,888 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | $ 327,775 | $ 255,411 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Reconciliation to amounts on consolidated balance sheets: | ||
Cash and cash equivalents | $ 326,512 | $ 254,154 |
Restricted cash | 1,263 | 1,257 |
Total cash, cash equivalents and restricted cash | 327,775 | 255,411 |
Cash paid for: | ||
Interest | $ 2,698 | $ 3,447 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2021 | |
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 TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQ received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapies. Currently, we have three programs in Phase 3 development for the treatment of patients with RMS and patients with CLL and several investigational medicines in Phase 1 clinical development. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities. Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles (GAAP), for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they may not include all of the information and footnotes required by GAAP for complete financial statements. All adjustments that are, in the opinion of management, of a normal recurring nature and are necessary for a fair presentation of the condensed consolidated financial statements have been included. Nevertheless, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying condensed December 31, 2020 balance sheet has been derived from these statements. The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. In December 2018, the Company created an Australian corporation, TG Therapeutics AUS Pty Ltd. (TG AUS), as a wholly-owned subsidiary. This corporation’s functional currency, the Australian dollar, is also its reporting currency, and its financial statements are translated to U.S. dollars, the Company’s reporting currency, prior to consolidation. The activities of TG AUS result in immaterial currency translation adjustments and, thus, are included in Other Income/Expense on the Company’s condensed consolidated statement of operations. The accompanying condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and all intercompany accounts and transactions have been eliminated in consolidation. 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 September 30, 2021, we have an accumulated deficit of $1.2 billion. Our major sources of cash have been proceeds from private placements and public offerings of equity securities. In February of 2021, umbralisib, now referred to as UKONIQ, was granted accelerated approval in the United States for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapy. Commercial sales of UKONIQ commenced in the first quarter of 2021. We have generated limited revenues to date from product sales. Even with the commercialization of UKONIQ and the potential future commercialization of our other drug candidates, we may not meet revenue guidance or become profitable. Our ability to achieve profitability depends on many factors, including our ability to generate revenue, our ability to obtain regulatory approvals for our drug candidates, our ability to successfully complete any post-approval regulatory obligations and our ability to successfully commercialize our drug candidates. We may continue to incur substantial operating losses even as we begin to generate revenues from our drug candidates. As of September 30, 2021, we had $381.4 million in cash and cash equivalents, and investment securities. We anticipate that our cash and cash equivalents, and investment securities as of September 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our UKONIQ commercialization efforts, preparations for the potential commercialization of our other drug candidates, and 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 ongoing and future 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.” Summary of Significant Accounting Policies Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2020 Annual Report on Form 10-K, except as it relates to revenue recognition, accounts receivable, inventory, cost of product revenue, and the adoption of new accounting standards during the nine months ended September 30, 2021, as discussed below. Revenue Recognition Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five-step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation. At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. Product Revenue, Net These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment). The Company's estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company's current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration received may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. Chargebacks and Administrative Fees: Chargebacks for discounts represent the Company's estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers and government agencies at prices lower than the list prices charged to the customers who directly purchase the product from the Company. The customers charge the Company for the difference between what the customers pay the Company for the product and the customers’ ultimate contractually committed or government required lower selling price to the qualified healthcare providers. As part of the Company's contractual commitments to sell product to qualified healthcare providers, the Company pays fees for administrative services, such as account management and data reporting. Government Rebates: Government rebates consist of Medicare, Tricare, and Medicaid rebates. These reserves are recorded in the same period the related revenue is recognized. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe a rebate under the Medicare Part D program. GPO and Payor Rebates: the Company contracts with various private payor organizations and group purchasing organizations (GPO), primarily insurance companies, pharmacy benefit managers and clinics, for the payment of rebates with respect to utilization of our product. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Trade Discounts and Allowances: The Company provides its customers with discounts that are explicitly stated in the contracts and are recorded in the period the related product revenue is recognized. In addition, the Company also receives sales order management, inventory management, and data services from its customers in exchange for certain fees. Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel. Subject to certain limitations, the Company’s return policy allows for eligible returns of UKONIQ for credit under the following circumstances: ● receipt of damaged product; ● shipment errors that were a result of an error by the Company; ● expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date; ● product subject to a recall; and ● product that the Company, at its sole discretion, has specified can be returned for credit. As of September 30, 2021, the Company has not received any returns. Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider. Reserves for co-payment assistance are recorded in the same period the related revenue is recognized. Accounts Receivable In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. Our contracts with customers have standard payment terms. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of September 30, 2021, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. Cost of Product Revenue Cost of product revenue consists primarily of materials and third-party manufacturing costs, as well as freight and royalties owed to our licensing partner for UKONIQ sales. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three and nine months ended September 30, 2021 were expensed prior to receipt of FDA approval on February 5, 2021, and therefore are not included in costs of product revenue during the current period. Inventory Prior to regulatory approval, we expense costs relating to the production of inventory as research and development expense in the period incurred. Following regulatory approval, costs to manufacture those approved products will be capitalized. Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in-first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the approval of UKONIQ, all manufacturing and other potential costs related to the commercial launch of UKONIQ were expensed to research and development expense in the period incurred. 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 should the Company realize net income during the period presented. The cumulative amounts of potentially dilutive securities excluded from the calculation were 13,126,038 securities and 11,103,701 securities for the nine months ended September 30, 2021 and 2020, respectively. The following outstanding shares of potentially dilutive securities were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: Nine Months Ended September 30, 2021 2020 Unvested restricted stock 10,492,731 8,409,696 Options 2,467,537 2,529,133 Warrants 147,058 147,058 Shares issuable upon note conversion 18,712 17,814 Total 13,126,038 11,103,701 Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (FASB) issued ASU No 2019-12, Income Taxes (Topic 740): Simplifying Accounting for Income Taxes (ASU 2019-12). ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocations, calculating income taxes in interim periods, and adds certain guidance to remove complexity in certain areas. ASU 2019-12 is effective for all entities for annual and interim periods beginning after December 15, 2020. Early adoption of either the entire standard or only those provisions that eliminate or modify requirements is permitted. Adoption of ASU 2019-12 did not have any impact to our condensed consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-04, Simplifying the Test for Goodwill Impairment (ASU 2017-04). ASU 2017-04 eliminates the requirement to calculate the implied fair value of goodwill (i.e., Step 2 of today’s goodwill impairment test) to measure a goodwill impairment charge. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). The standard has tiered effective dates, starting in 2020 for calendar-year public business entities PBEs that meet the definition of an SEC filer, excluding smaller reporting companies. Early adoption is permitted for annual and interim goodwill impairment testing dates after 1 January 2017. Adoption of ASU 2017-04 did not have any impact to our condensed consolidated financial statements. 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. |
REVENUE RECOGNITION
REVENUE RECOGNITION | 9 Months Ended |
Sep. 30, 2021 | |
REVENUE RECOGNITION. | |
REVENUE RECOGNITION | NOTE 2 REVENUE RECOGNITION Gross-to-Net Sales Adjustments To date, our only source of product revenue has been from the U.S. sales of UKONIQ, which we began shipping to our customers in February 2021. We record our best estimate of sales discounts and allowances to which customers are likely to be entitled. The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the three and nine months ended September 30, 2021: (in thousands) Three months ended Nine months ended September 30, 2021 September 30, 2021 Gross product revenue $ 2,528 $ 5,167 Gross-to-net adjustments: Chargebacks and administrative fees (292) (487) Trade discounts and allowances (128) (222) Government rebates and co-payment assistance (103) (179) Sales returns and allowances (13) (25) Total gross-to-net adjustments (1) $ (536) $ (913) Net product revenue $ 1,992 $ 4,254 (1) |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 9 Months Ended |
Sep. 30, 2021 | |
INVESTMENT SECURITIES | |
INVESTMENT SECURITIES | NOTE 3 INVESTMENT SECURITIES Our investments as of September 30, 2021 and December 31, 2020 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following table summarize our investment securities at September 30, 2021 and December 31, 2020: September 30, 2021 Amortized Gross Gross cost, as unrealized unrealized Estimated (in thousands) adjusted holding gains holding losses fair value Short-term investments: Obligations of domestic governmental agencies (maturing between October 2021 and April 2022) (held-to-maturity) $ 30,338 $ 3 $ 1 $ 30,340 Long-term investments: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity) 24,550 1 12 24,539 Total short-term and long-term investment securities $ 54,888 $ 4 $ 13 $ 54,879 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 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2021 | |
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 condensed consolidated 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 September 30, 2021 and December 31, 2020, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable, approximate their carrying values. The following tables provide the fair value measurements of applicable financial liabilities as of September 30, 2021 and December 31, 2020: Financial liabilities at fair value as of September 30, 2021 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 623 $ 623 Total $ — $ — $ 623 $ 623 Financial liabilities at fair value as of December 31, 2020 Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 938 $ 938 Total $ — $ — $ 938 $ 938 The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest. The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts payable and debt. Cash, cash equivalents, accounts payable and debt are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. The following table summarizes the changes in Level 3 instruments during the nine months ended September 30, 2021: (in thousands) Balance at December 31, 2020 938 Interest accrued on face value of 5% Notes 764 Change in fair value of Level 3 liabilities (1,079) Balance at September 30, 2021 $ 623 The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying condensed consolidated statements of operations. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2021 | |
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, we 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. Common Stock Our amended and restated certificate of incorporation authorizes the issuance of up to 175,000,000 shares of $0.001 par value common stock. 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 paid 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. The 2021 ATM has replaced the 2020 ATM as the only active ATM program. We had no activity on the 2021 ATM during the nine months ended September 30, 2021. 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. Equity Incentive Plans The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020. As of September 30, 2021, 11,992,744 shares of restricted stock and 2,467,537 options were outstanding and up to an additional 1,746,700 shares may be issued under the 2012 Incentive Plan. Stock-based compensation expense included in the condensed consolidated statements of operations was $14.0 million and $28.3 million for the three months ended September 30, 2021 and 2020, respectively, and $46.9 million and $46.8 million for the nine months ended September 30, 2021 and 2020, respectively. The following table summarizes the activity for stock options and restricted stock for the nine months ended September 30, 2021: (in thousands) Stock Options Restricted Stock Equity awards outstanding, beginning of year 2,526 10,785 Changes during the year: Granted — 2,464 Exercised or vested (53) (1,106) Expired or Forfeited (6) (150) Equity awards outstanding, end of period 2,467 11,993 As of September 30, 2021, total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized were as follows: (in thousands) Stock Options Restricted Stock Unrecognized compensation cost $ 523 $ 66,962 Expected weighted-average period in years of compensation cost to be recognized 1.0 1.0 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 6 for further details. As the warrants could not require cash settlement, the warrants were classified as equity. There will not be any ongoing stock compensation expense volatility associated with these warrants. |
LOAN PAYABLE
LOAN PAYABLE | 9 Months Ended |
Sep. 30, 2021 | |
LOAN PAYABLE | |
LOAN PAYABLE | NOTE 6 LOAN PAYABLE On February 28, 2019 (the Closing Date), we entered into a term loan facility of up to $60.0 million (Term Loan) with Hercules Capital, Inc. (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. An additional $30.0 million was available with different milestones and time points that have lapsed. 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 plus 4.75%, and (ii) 10.25%. As a result of the Company having raised in excess of $150 million before the required timeline in the Loan Agreement, the interest-only period was extended to April 1, 2021. At our option, we may prepay all or any portion greater than or equal to $5.0 million of the outstanding advances by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest, subject to a prepayment charges of: 3.0% if such advance is prepaid in any of the first twelve months following the Closing Date; 1.5% if such advance is prepaid after the first twelve months following the Closing Date but on or prior to twenty-four months following the Closing Date; and 0% thereafter. In addition, a final payment equal to 3.5% of the aggregate principal amount of the loan extended by Hercules is due on the maturity date. As of September 30, 2021, we have paid approximately $14.6 million of the principal loan balance due to Hercules. The Term Loan repayment schedule continues with monthly principal payments ranging from approximately $2.5 million to $2.7 million per month through March 1, 2022. The Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, and contains customary covenants and representations. As of September 30, 2021 and through the filing date of this report, the Company has been in compliance with all covenants. The Loan Agreement contains several events of default, which we are in compliance with all terms. If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement. Amounts outstanding during an event of default shall be payable on demand and accrue interest at an additional rate of 4.0% per annum of the past due amount outstanding. 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. 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’ (deficit) 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 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 loan payable on the Company’s unaudited condensed 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 unaudited condensed consolidated statements of operations. Amortization of debt issuance costs was $0.3 million and $0.2 million for each of the three months ended September 30, 2021 and 2020, respectively, and $0.7 million for each of the nine months ended September 30, 2021 and 2020, respectively. At September 30, 2021, the remaining unamortized balance of debt issuance costs was $0.4 million. The loan payable as of September 30, 2021 and December 31, 2020 is as follows: September 30, December 31, (in thousands) 2021 2020 Loan payable $ 30,000 $ 30,000 End of term fee 975 975 30,975 30,975 Less: unamortized debt issuance costs (386) (1,080) 30,589 29,895 Less: principal payments (14,590) — Total loan payable 15,999 29,895 Less: current portion (15,999) (22,179) Loan payable non-current $ — $ 7,716 |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2021 | |
LEASES | |
LEASES | NOTE 7 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 lease. We approximate an average annual rental obligation of $1.4 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. At January 1, 2019, we recognized a lease liability and corresponding Right-of-Use (ROU) asset of $9.5 million and $8.1 million, respectively, based on the present value of the remaining lease payments for all of our leased office spaces, the majority of which is comprised of our New York City office space. The present values of our lease liability and corresponding ROU asset are $11.5 million and $8.8 million, respectively, as of September 30, 2021. Our leases have remaining lease terms of 2 years to 10 years. One lease has a renewal option to extend the lease for an additional term of two years. 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 September 30, 2021, the allocation rate is 65% and will be evaluated again in November 2021 for the following rent year. Also in connection with this lease, we have pledged $1.2 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 condensed consolidated balance sheets. In October 2019, we finalized a five-year The following components of lease expense are included in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020: Three months ended Nine months ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Operating lease cost $ 532 $ 534 $ 1,595 $ 1,611 Net lease cost $ 532 $ 534 $ 1,595 $ 1,611 As of September 30, 2021, the weighted-average remaining operating lease term was 7.4 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 nine months ended September 30, 2021 was $1.5 million. The balance sheet classification of lease liabilities was as follows: September 30, December 31, (in thousands) 2021 2020 Liabilities Lease liability current portion $ 1,468 $ 1,669 Lease liability non-current 10,020 10,412 Total lease liability $ 11,488 $ 12,081 As of September 30, 2021, the maturities of lease liabilities were as follows: Operating (in thousands) leases Remainder of 2021 $ 505 2022 2,035 2023 2,040 2024 1,924 2025 1,653 After 2026 9,889 Total lease payments 18,046 Less: interest (6,558) Present value of lease liabilities(*) $ 11,488 (*) 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. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 9 Months Ended |
Sep. 30, 2021 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 8 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 $38,000 for each of the three months ended September 30, 2021 and 2020, and approximately $114,000 for each of the nine months ended September 30, 2021 and 2020, and at September 30, 2021 and December 31, 2020, have deferred revenue of approximately $0.6 million and $0.8 million, respectively, associated with this $2.0 million payment (approximately $0.2 million of which has been classified in current liabilities at September 30, 2021 and December 31, 2020). 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. In January 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 and commercialization of ublituximab. Under the license agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. As of September 30, 2021 we have incurred and paid approximately $10.0 million related to milestones. LFB Group is eligible to receive payments of up to an aggregate of approximately $31.0 million upon our successful achievement of certain clinical development, regulatory, and sales milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate that escalates from mid-single digits to high-single digits. The license will terminate on a country by country basis upon 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 (i) by LFB if the Company challenges any of the licensed patent rights, (ii) by either party due to a breach of the agreement, or (iii) by either party in the event of the insolvency of the other party. TGR-1202 (Umbralisib) In September 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the Umbralisib 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. During the nine months ended September 30, 2021, we paid Rhizen $12.0 million as part of a primary indication approval milestone for launch of product in the US in accordance with the terms of the Umbralisib License. Rhizen will be eligible to receive additional approval and sales-based milestone payments in the aggregate of approximately $175 million payable upon 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 receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib and any New Product. During the three and nine months ended September 30, 2021, the Company recorded $0.1 million and $0.3 million, respectively, related to the worldwide royalty due under the Umbralisib License in cost of product revenue based on U.S. sales of UKONIQ and as of September 30, 2021, $0.1 million in royalties were payable under the Umbralisib License. Rhizen will 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. The license will terminate on a country by country basis upon the expiration of the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, or (ii) by either party due to a breach of the agreement. TG-1501: PDL1 (Cosibelimab) In March 2015, we entered into a Global Collaboration Agreement (Collaboration Agreement) with Checkpoint Therapeutics, Inc. (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 in March of 2020 we achieved the first milestone event for which we incurred expenses of zero for each of the three months ended September 30, 2021 and 2020, and zero and approximately $0.9 million for the nine months ended September 30, 2021 and 2020, respectively. 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 Brutons Tyrosine Kinase inhibitors containing the compounds of either TG1701 (SHR1459 or EBI1459) or TG-1702 (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 condensed consolidated statement of operations. 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. In July 2020, we paid Hengrui $2.0 million as part of a milestone in accordance with the license agreement. 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. We incurred expenses of approximately $4.2 million and $0.3 million for the three months ended September 30, 2021 and 2020, respectively, and $9.0 million and $0.6 million for the nine months ended September 30, 2021 and 2020, respectively, the majority of which relates to manufacturing expenses of BTK. The relevant expenses are recorded in other research and development in the accompanying unaudited condensed consolidated statement of operations. 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. As of September 30, 2021, we have incurred approximately $2.0 million in milestone expense related to patient enrollment. 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 | 9 Months Ended |
Sep. 30, 2021 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 9 RELATED PARTY TRANSACTIONS 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 $0.2 million for each of the three months ended September 30, 2021 and 2020, and expenses of approximately $0.6 million for each of the nine months ended September 30, 2021 and 2020, primarily related to shared personnel. Please refer to Note 7 - Leases for details regarding the Office Agreement with FBIO, as well as Note 8 - License Agreements for details regarding the Collaboration Agreement with Checkpoint. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles (GAAP), for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they may not include all of the information and footnotes required by GAAP for complete financial statements. All adjustments that are, in the opinion of management, of a normal recurring nature and are necessary for a fair presentation of the condensed consolidated financial statements have been included. Nevertheless, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying condensed December 31, 2020 balance sheet has been derived from these statements. The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. In December 2018, the Company created an Australian corporation, TG Therapeutics AUS Pty Ltd. (TG AUS), as a wholly-owned subsidiary. This corporation’s functional currency, the Australian dollar, is also its reporting currency, and its financial statements are translated to U.S. dollars, the Company’s reporting currency, prior to consolidation. The activities of TG AUS result in immaterial currency translation adjustments and, thus, are included in Other Income/Expense on the Company’s condensed consolidated statement of operations. The accompanying condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and all intercompany accounts and transactions have been eliminated in consolidation. |
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 September 30, 2021, we have an accumulated deficit of $1.2 billion. Our major sources of cash have been proceeds from private placements and public offerings of equity securities. In February of 2021, umbralisib, now referred to as UKONIQ, was granted accelerated approval in the United States for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapy. Commercial sales of UKONIQ commenced in the first quarter of 2021. We have generated limited revenues to date from product sales. Even with the commercialization of UKONIQ and the potential future commercialization of our other drug candidates, we may not meet revenue guidance or become profitable. Our ability to achieve profitability depends on many factors, including our ability to generate revenue, our ability to obtain regulatory approvals for our drug candidates, our ability to successfully complete any post-approval regulatory obligations and our ability to successfully commercialize our drug candidates. We may continue to incur substantial operating losses even as we begin to generate revenues from our drug candidates. As of September 30, 2021, we had $381.4 million in cash and cash equivalents, and investment securities. We anticipate that our cash and cash equivalents, and investment securities as of September 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our UKONIQ commercialization efforts, preparations for the potential commercialization of our other drug candidates, and 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 ongoing and future 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.” |
Revenue Recognition | Revenue Recognition Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five-step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation. At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. Product Revenue, Net These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment). The Company's estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company's current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration received may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. Chargebacks and Administrative Fees: Chargebacks for discounts represent the Company's estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers and government agencies at prices lower than the list prices charged to the customers who directly purchase the product from the Company. The customers charge the Company for the difference between what the customers pay the Company for the product and the customers’ ultimate contractually committed or government required lower selling price to the qualified healthcare providers. As part of the Company's contractual commitments to sell product to qualified healthcare providers, the Company pays fees for administrative services, such as account management and data reporting. Government Rebates: Government rebates consist of Medicare, Tricare, and Medicaid rebates. These reserves are recorded in the same period the related revenue is recognized. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe a rebate under the Medicare Part D program. GPO and Payor Rebates: the Company contracts with various private payor organizations and group purchasing organizations (GPO), primarily insurance companies, pharmacy benefit managers and clinics, for the payment of rebates with respect to utilization of our product. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. Trade Discounts and Allowances: The Company provides its customers with discounts that are explicitly stated in the contracts and are recorded in the period the related product revenue is recognized. In addition, the Company also receives sales order management, inventory management, and data services from its customers in exchange for certain fees. Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel. Subject to certain limitations, the Company’s return policy allows for eligible returns of UKONIQ for credit under the following circumstances: ● receipt of damaged product; ● shipment errors that were a result of an error by the Company; ● expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date; ● product subject to a recall; and ● product that the Company, at its sole discretion, has specified can be returned for credit. As of September 30, 2021, the Company has not received any returns. Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider. Reserves for co-payment assistance are recorded in the same period the related revenue is recognized. |
Accounts Receivable | Accounts Receivable In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. Our contracts with customers have standard payment terms. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of September 30, 2021, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances. |
Cost of Product Revenue | Cost of Product Revenue Cost of product revenue consists primarily of materials and third-party manufacturing costs, as well as freight and royalties owed to our licensing partner for UKONIQ sales. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three and nine months ended September 30, 2021 were expensed prior to receipt of FDA approval on February 5, 2021, and therefore are not included in costs of product revenue during the current period. |
Inventory | Inventory Prior to regulatory approval, we expense costs relating to the production of inventory as research and development expense in the period incurred. Following regulatory approval, costs to manufacture those approved products will be capitalized. Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in-first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the approval of UKONIQ, all manufacturing and other potential costs related to the commercial launch of UKONIQ were expensed to research and development expense in the period incurred. |
Net Loss Per Common Share | 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 should the Company realize net income during the period presented. The cumulative amounts of potentially dilutive securities excluded from the calculation were 13,126,038 securities and 11,103,701 securities for the nine months ended September 30, 2021 and 2020, respectively. The following outstanding shares of potentially dilutive securities were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: Nine Months Ended September 30, 2021 2020 Unvested restricted stock 10,492,731 8,409,696 Options 2,467,537 2,529,133 Warrants 147,058 147,058 Shares issuable upon note conversion 18,712 17,814 Total 13,126,038 11,103,701 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (FASB) issued ASU No 2019-12, Income Taxes (Topic 740): Simplifying Accounting for Income Taxes (ASU 2019-12). ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocations, calculating income taxes in interim periods, and adds certain guidance to remove complexity in certain areas. ASU 2019-12 is effective for all entities for annual and interim periods beginning after December 15, 2020. Early adoption of either the entire standard or only those provisions that eliminate or modify requirements is permitted. Adoption of ASU 2019-12 did not have any impact to our condensed consolidated financial statements. In January 2017, the FASB issued ASU No. 2017-04, Simplifying the Test for Goodwill Impairment (ASU 2017-04). ASU 2017-04 eliminates the requirement to calculate the implied fair value of goodwill (i.e., Step 2 of today’s goodwill impairment test) to measure a goodwill impairment charge. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). The standard has tiered effective dates, starting in 2020 for calendar-year public business entities PBEs that meet the definition of an SEC filer, excluding smaller reporting companies. Early adoption is permitted for annual and interim goodwill impairment testing dates after 1 January 2017. Adoption of ASU 2017-04 did not have any impact to our condensed consolidated financial statements. 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. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Nine Months Ended September 30, 2021 2020 Unvested restricted stock 10,492,731 8,409,696 Options 2,467,537 2,529,133 Warrants 147,058 147,058 Shares issuable upon note conversion 18,712 17,814 Total 13,126,038 11,103,701 |
REVENUE RECOGNITION (Tables)
REVENUE RECOGNITION (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
REVENUE RECOGNITION. | |
Reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments | (in thousands) Three months ended Nine months ended September 30, 2021 September 30, 2021 Gross product revenue $ 2,528 $ 5,167 Gross-to-net adjustments: Chargebacks and administrative fees (292) (487) Trade discounts and allowances (128) (222) Government rebates and co-payment assistance (103) (179) Sales returns and allowances (13) (25) Total gross-to-net adjustments (1) $ (536) $ (913) Net product revenue $ 1,992 $ 4,254 |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
INVESTMENT SECURITIES | |
Schedule of held-to-maturity securities | The following table summarize our investment securities at September 30, 2021 and December 31, 2020: September 30, 2021 Amortized Gross Gross cost, as unrealized unrealized Estimated (in thousands) adjusted holding gains holding losses fair value Short-term investments: Obligations of domestic governmental agencies (maturing between October 2021 and April 2022) (held-to-maturity) $ 30,338 $ 3 $ 1 $ 30,340 Long-term investments: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity) 24,550 1 12 24,539 Total short-term and long-term investment securities $ 54,888 $ 4 $ 13 $ 54,879 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 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
FAIR VALUE MEASUREMENTS | |
Schedule of the fair value measurements of applicable financial liabilities | The following tables provide the fair value measurements of applicable financial liabilities as of September 30, 2021 and December 31, 2020: Financial liabilities at fair value as of September 30, 2021 (in thousands) Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 623 $ 623 Total $ — $ — $ 623 $ 623 Financial liabilities at fair value as of December 31, 2020 Level 1 Level 2 Level 3 Total 5% Notes $ — $ — $ 938 $ 938 Total $ — $ — $ 938 $ 938 |
Schedule of change in level three fair value during period | The following table summarizes the changes in Level 3 instruments during the nine months ended September 30, 2021: (in thousands) Balance at December 31, 2020 938 Interest accrued on face value of 5% Notes 764 Change in fair value of Level 3 liabilities (1,079) Balance at September 30, 2021 $ 623 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
STOCKHOLDERS' EQUITY | |
Summary of activity for stock options and restricted stock | The following table summarizes the activity for stock options and restricted stock for the nine months ended September 30, 2021: (in thousands) Stock Options Restricted Stock Equity awards outstanding, beginning of year 2,526 10,785 Changes during the year: Granted — 2,464 Exercised or vested (53) (1,106) Expired or Forfeited (6) (150) Equity awards outstanding, end of period 2,467 11,993 |
Schedule of compensation cost related to unvested awards | As of September 30, 2021, total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized were as follows: (in thousands) Stock Options Restricted Stock Unrecognized compensation cost $ 523 $ 66,962 Expected weighted-average period in years of compensation cost to be recognized 1.0 1.0 |
LOAN PAYABLE (Tables)
LOAN PAYABLE (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
LOAN PAYABLE | |
Schedule of key assumptions | The Company estimated the fair value of the 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 loan payable | The loan payable as of September 30, 2021 and December 31, 2020 is as follows: September 30, December 31, (in thousands) 2021 2020 Loan payable $ 30,000 $ 30,000 End of term fee 975 975 30,975 30,975 Less: unamortized debt issuance costs (386) (1,080) 30,589 29,895 Less: principal payments (14,590) — Total loan payable 15,999 29,895 Less: current portion (15,999) (22,179) Loan payable non-current $ — $ 7,716 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
LEASES | |
Schedule of lease cost | The following components of lease expense are included in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020: Three months ended Nine months ended September 30, September 30, (in thousands) 2021 2020 2021 2020 Operating lease cost $ 532 $ 534 $ 1,595 $ 1,611 Net lease cost $ 532 $ 534 $ 1,595 $ 1,611 |
Schedule of classification of lease liabilities | The balance sheet classification of lease liabilities was as follows: September 30, December 31, (in thousands) 2021 2020 Liabilities Lease liability current portion $ 1,468 $ 1,669 Lease liability non-current 10,020 10,412 Total lease liability $ 11,488 $ 12,081 |
Schedule of lease liability maturity | As of September 30, 2021, the maturities of lease liabilities were as follows: Operating (in thousands) leases Remainder of 2021 $ 505 2022 2,035 2023 2,040 2024 1,924 2025 1,653 After 2026 9,889 Total lease payments 18,046 Less: interest (6,558) Present value of lease liabilities(*) $ 11,488 (*) 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. |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Accumulated deficit | $ 1,235,359 | $ 980,597 |
Cash and cash equivalents, and investment securities | $ 381,400 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Computation of diluted loss per share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 13,126,038 | 11,103,701 |
Unvested restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 10,492,731 | 8,409,696 |
Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 2,467,537 | 2,529,133 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 147,058 | 147,058 |
Share Issuable Upon Note Conversion [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 18,712 | 17,814 |
REVENUE RECOGNITION (Details)
REVENUE RECOGNITION (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | |
REVENUE RECOGNITION. | ||
Gross product revenue | $ 2,528 | $ 5,167 |
Chargebacks and administrative fees | (292) | (487) |
Trade discounts and allowances | (128) | (222) |
Government rebates and co-payment assistance | (103) | (179) |
Sales returns and allowances | (13) | (25) |
Total gross-to-net adjustments | (536) | (913) |
Net product revenue | 1,992 | 4,254 |
Estimated amount of gross net accruals | $ 400 | $ 400 |
INVESTMENT SECURITIES - Summary
INVESTMENT SECURITIES - Summary of investment securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Amortized cost, as adjusted | $ 54,888 | $ 51,987 |
Gross unrealized holding gains | 4 | 1 |
Gross unrealized holding losses | 13 | 4 |
Estimated fair value | 54,879 | 51,984 |
Short-term Investments [Member] | Obligations of domestic governmental agencies [Member] | ||
Amortized cost, as adjusted | 30,338 | 51,987 |
Gross unrealized holding gains | 3 | 1 |
Gross unrealized holding losses | 1 | 4 |
Estimated fair value | 30,340 | $ 51,984 |
Long-term investments [Member] | Obligations of domestic governmental agencies [Member] | ||
Amortized cost, as adjusted | 24,550 | |
Gross unrealized holding gains | 1 | |
Gross unrealized holding losses | 12 | |
Estimated fair value | $ 24,539 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Convertible Notes Payable [Member] | ||
Fair Value Measurement [Line Items] | ||
Det instrument rate | 5.00% | 5.00% |
FAIR VALUE MEASUREMENTS - Finan
FAIR VALUE MEASUREMENTS - Financial liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
5% Notes | $ 623 | $ 938 |
Totals | 623 | 938 |
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 | 623 | 938 |
Totals | $ 623 | $ 938 |
FAIR VALUE MEASUREMENTS - Summa
FAIR VALUE MEASUREMENTS - Summary of changes in Level 3 instruments (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
FAIR VALUE MEASUREMENTS | |
Balance at beginning of period | $ 938 |
Interest accrued on face value of 5% Notes | 764 |
Change in fair value of Level 3 liabilities | (1,079) |
Balance at end of period | $ 623 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Sep. 05, 2019 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Warrant purchase price | $ 4.08 | $ 4.08 | ||||
Warrants issued | 147,058 | 147,058 | ||||
Common Stock, Shares Authorized | 175,000,000 | 175,000,000 | 175,000,000 | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||
Stock-based compensation expense | $ 14,000 | $ 28,300 | $ 46,918 | $ 46,768 | ||
Warrants [Member] | ||||||
Warrant purchase price | $ 4.08 | $ 4.08 | ||||
Warrants issued | 147,058 | 147,058 | ||||
2020 ATM [Member] | ||||||
Percent of commission rate | 3.00% | |||||
Amended and Restated 2012 Incentive Plan [Member] | ||||||
Number of additional shares that may be issued | 1,746,700 | 1,746,700 | ||||
Amended and Restated 2012 Incentive Plan [Member] | Unvested restricted stock | ||||||
Restricted stock outstanding | 11,992,744 | 11,992,744 | ||||
Amended and Restated 2012 Incentive Plan [Member] | Stock options | ||||||
Restricted stock outstanding | 2,467,537 | 2,467,537 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) | 9 Months Ended |
Sep. 30, 2021shares | |
Stock options | |
Equity Incentive Plans Stock Option Activity [Line Items] | |
Equity awards outstanding, beginning of year | 2,526 |
Number of shares, Exercised/Vested | (53) |
Number of shares, Expired/Forfeited | (6) |
Equity awards outstanding, end of period | 2,467 |
Unvested restricted stock | |
Equity Incentive Plans Stock Option Activity [Line Items] | |
Equity awards outstanding, beginning of year | 10,785 |
Number of shares, Granted. | 2,464 |
Number of shares, Exercised/Vested | (1,106) |
Number of shares, Expired/Forfeited | (150) |
Equity awards outstanding, end of period | 11,993 |
STOCKHOLDERS' EQUITY - Unvested
STOCKHOLDERS' EQUITY - Unvested awards (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Unvested restricted stock | |
Unrecognized compensation cost | $ 66,962 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year |
Stock options | |
Unrecognized compensation cost | $ 523 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year |
LOANS PAYABLE (Details)
LOANS PAYABLE (Details) $ in Thousands | Feb. 28, 2019USD ($)loan | Sep. 30, 2021USD ($) |
Debt Instrument [Line Items] | ||
Payment of loan payable | $ (14,590) | |
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 | |
Additional advances not drawn | 30,000 | |
Minimum amount raised from unrestricted cash proceeds | 150,000 | |
Expected prepayment on outstanding advances | $ 5,000 | |
Prepayment charge (as a percent) | 3.50% | |
Payment of loan payable | 14,600 | |
Interest on past due outstanding (as a percent) | 4.00% | |
Term Loan [Member] | Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Amount of monthly principal payments | 2,500 | |
Term Loan [Member] | Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Number of advances | loan | 4 | |
Amount of monthly principal payments | $ 2,700 | |
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% |
LOANS PAYABLE - Warrants fair v
LOANS PAYABLE - Warrants fair value (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 21 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | |
Warrants issued | 147,058 | 147,058 | 147,058 | |||
Warrant purchase price | $ 4.08 | $ 4.08 | $ 4.08 | |||
Amortization of debt issuance costs | $ 300 | $ 200 | $ 694 | $ 694 | $ 700 | |
Unamortized Debt Issuance Expense | $ 386 | $ 386 | $ 386 | $ 1,080 | ||
Warrants [Member] | ||||||
Warrant coverage percentage | 2.00% | |||||
Warrants issued | 147,058 | 147,058 | 147,058 | |||
Warrant purchase price | $ 4.08 | $ 4.08 | $ 4.08 | |||
Class Of Warrant Or Right Fair Value | $ 1,000 | $ 1,000 | $ 1,000 | |||
Financing expenses, Hercules Loan Agreement | $ 2,800 |
LOANS PAYABLE - Estimated fair
LOANS PAYABLE - Estimated fair value of warrants (Details) - Warrants [Member] | 9 Months Ended |
Sep. 30, 2021$ / 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 |
LOANS PAYABLE - Summary (Detail
LOANS PAYABLE - Summary (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
LOAN PAYABLE | ||
Loan payable | $ 30,000 | $ 30,000 |
End of term fee | 975 | 975 |
Loan payable, gross | 30,975 | 30,975 |
Less: unamortized debt issuance costs | (386) | (1,080) |
Loan payable | 30,589 | 29,895 |
Less: principal payments | (14,590) | |
Total loan payable | 15,999 | 29,895 |
Less: Current portion | $ (15,999) | (22,179) |
Loan payable non-current | $ 7,716 |
LEASES (Details)
LEASES (Details) $ in Thousands | Oct. 31, 2014USD ($)ft² | Oct. 31, 2019USD ($) | Oct. 31, 2014USD ($)ft² | Sep. 30, 2021USD ($)lease | Dec. 31, 2020USD ($) | Feb. 28, 2019 | Jan. 01, 2019USD ($) |
Right of use assets | $ 8,804 | $ 9,312 | |||||
Operating Lease Liability | $ 11,488 | $ 12,081 | |||||
ASU 2016-02 | Restatement Adjustment | |||||||
Right of use assets | $ 9,500 | ||||||
Operating Lease Liability | $ 8,100 | ||||||
Office Agreement [Member] | |||||||
Percentage Of Occupancy | 45.00% | 65.00% | |||||
Area of Land | ft² | 24,000 | 24,000 | |||||
Operating lease initial commitment period | 15 years | ||||||
Average Annual Rental Payments | $ 1,400 | ||||||
Right of use assets | $ 8,800 | ||||||
Operating Lease Liability | $ 11,500 | ||||||
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 | $ 1,200 | $ 1,200 | |||||
Weighted-average discount rate for operating leases | 10.25% | 10.25% | |||||
Weighted-average remaining operating lease term | 7 years 4 months 24 days | ||||||
Operating Lease, Payments, Use | $ 1,500 | ||||||
Office Agreement [Member] | Minimum [Member] | |||||||
Remaining lease term | 2 years | ||||||
Office Agreement [Member] | Maximum [Member] | |||||||
Remaining lease term | 10 years | ||||||
NJ Lease [Member] | |||||||
Operating lease initial commitment period | 5 years | ||||||
Average Annual Rental Payments | $ 300 | $ 200 |
LEASES - Components of lease ex
LEASES - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
LEASES | ||||
Operating lease cost | $ 532 | $ 534 | $ 1,595 | $ 1,611 |
Net lease cost | $ 532 | $ 534 | $ 1,595 | $ 1,611 |
LEASES - Classification of leas
LEASES - Classification of lease liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
LEASES | ||
Lease liability current portion | $ 1,468 | $ 1,669 |
Lease liability non-current | 10,020 | 10,412 |
Total lease liability | $ 11,488 | $ 12,081 |
LEASES - Maturities of lease li
LEASES - Maturities of lease liabilities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
LEASES | |
Remainder of 2021 | $ 505 |
2022 | 2,035 |
2023 | 2,040 |
2024 | 1,924 |
2025 | 1,653 |
After 2026 | 9,889 |
Total lease payments | 18,046 |
Less: Interest | (6,558) |
Present value of lease liabilities | $ 11,488 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 15 Months Ended | ||||||||
Jul. 31, 2020USD ($) | Jul. 31, 2019USD ($) | Apr. 30, 2018USD ($) | May 31, 2016USD ($) | Dec. 31, 2012USD ($) | Sep. 30, 2021USD ($)item | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)item | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)item | Dec. 31, 2020USD ($) | Nov. 30, 2012USD ($) | |
Revenue | $ 2,030,000 | $ 38,000 | $ 4,368,000 | $ 114,000 | ||||||||
Eligible payments to be received | 47,433,000 | 45,846,000 | 140,872,000 | 114,785,000 | ||||||||
TG-1101 [Member] | ||||||||||||
Upfront fee | $ 5,000,000 | $ 2,000,000 | ||||||||||
Income taxes | $ 300,000 | |||||||||||
Revenue | 38,000 | 38,000 | 114,000 | 114,000 | ||||||||
Term after first commercial sale | 15 years | |||||||||||
Deferred Revenue | 600,000 | 600,000 | $ 600,000 | $ 800,000 | ||||||||
Deferred Revenue, Current | 200,000 | 200,000 | 200,000 | |||||||||
TG-1701 [Member] | ||||||||||||
Upfront fee | $ 100,000 | $ 1,000,000 | 350,000,000 | |||||||||
Milestone payment made | $ 2,000,000 | |||||||||||
Expenses incurred | 4,200,000 | $ 300,000 | 9,000,000 | 600,000 | ||||||||
TG-1801 [Member] | ||||||||||||
Upfront fee | 3,000,000 | |||||||||||
Additional payments on achievement of certain milestones | $ 185,000,000 | |||||||||||
Expenses incurred | 2,000,000 | |||||||||||
TGR-1202 [Member] | ||||||||||||
Additional payments on achievement of certain milestones | $ 175,000,000 | 175,000,000 | $ 175,000,000 | |||||||||
Milestone payment made | $ 12,000,000 | |||||||||||
Number of oncology indications | item | 2 | 2 | 2 | |||||||||
Number of non oncology indications | item | 1 | 1 | 1 | |||||||||
Royalty Expense | $ 100,000 | $ 300,000 | ||||||||||
Expenses incurred | $ 100,000 | |||||||||||
TG 1501 [Member] | ||||||||||||
Expenses incurred | 0 | $ 900,000 | $ 0 | |||||||||
LFB Group [Member] | LFB License Agreement | ||||||||||||
Eligible payments to be received | $ 31,000,000 | |||||||||||
Operating lease initial commitment period | 15 years | |||||||||||
Expenses incurred | $ 10,000,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Millions | 15 Months Ended | 21 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Shared Services Agreement [Member] | ||
Related Party Transaction [Line Items] | ||
Expenses incurred | $ 0.2 | $ 0.6 |