Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 02, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 | 3020 Carrington Mill Blvd, Suite 475 | |
Entity Address, City or Town | Morrisville | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27560 | |
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 | 149,396,038 | |
Entity Central Index Key | 0001001316 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 61,469 | $ 102,304 |
Short-term investment securities | 78,241 | 59,374 |
Accounts receivable, net | 8,623 | |
Inventories | 27,221 | |
Prepaid research and development | 4,771 | 4,237 |
Other current assets | 4,458 | 2,359 |
Total current assets | 184,783 | 168,274 |
Restricted cash | 1,276 | 1,273 |
Long-term investment securities | 12,404 | |
Right of use assets | 8,689 | 8,888 |
Leasehold interest, net | 1,574 | 1,627 |
Equipment, net | 237 | 307 |
Goodwill | 799 | 799 |
Total assets | 197,358 | 193,572 |
Current liabilities: | ||
Accounts payable and accrued expenses | 57,092 | 42,019 |
Other current liabilities | 1,221 | 1,169 |
Lease liability - current portion | 1,546 | 1,581 |
Accrued compensation | 3,217 | 8,432 |
Total current liabilities | 63,076 | 53,201 |
Deferred revenue, net of current portion | 267 | 305 |
Loan payable - non-current | 96,503 | 71,135 |
Lease liability - non-current | 10,079 | 10,344 |
Total liabilities | 169,925 | 134,985 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value per share (175,000,000 shares authorized, 149,437,347 and 146,426,697 shares issued, 149,396,038 and 146,385,388 shares outstanding at March 31, 2023 and December 31, 2022, respectively) | 149 | 146 |
Additional paid-in capital | 1,593,783 | 1,585,708 |
Treasury stock, at cost, 41,309 shares at March 31, 2023 and December 31, 2022 | (234) | (234) |
Accumulated deficit | (1,566,265) | (1,527,033) |
Total stockholders' equity | 27,433 | 58,587 |
Total liabilities and stockholders' equity | $ 197,358 | $ 193,572 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 149,437,347 | 146,426,697 |
Common stock, shares outstanding | 149,396,038 | 146,385,388 |
Treasury stock, shares | 41,309 | 41,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Revenue | $ 7,803 | $ 2,016 |
Costs and expenses: | ||
Cost of product revenue | 857 | 237 |
Research and development: | ||
Noncash compensation | 1,584 | 1,895 |
Other research and development | 14,286 | 46,147 |
Total research and development | 15,870 | 48,042 |
Selling, general and administrative: | ||
Noncash compensation | 5,240 | 226 |
Other selling, general and administrative | 22,828 | 20,383 |
Total selling, general and administrative | 28,068 | 20,609 |
Total costs and expenses | 44,795 | 68,888 |
Operating loss | (36,992) | (66,872) |
Other expense (income): | ||
Interest expense | 2,844 | 2,664 |
Other income | (604) | (523) |
Total other expense (income), net | 2,240 | 2,141 |
Net loss | $ (39,232) | $ (69,013) |
Basic net loss per common share (in dollars per share) | $ (0.28) | $ (0.51) |
Diluted net loss per common share (in dollars per share) | $ (0.28) | $ (0.51) |
Weighted-average shares used in computing basic net loss per common share (in shares) | 140,312,269 | 134,400,500 |
Weighted-average shares used in computing diluted net loss per common share (in shares) | 140,312,269 | 134,400,500 |
Product revenue, net [Member] | ||
Revenue: | ||
Revenue | $ 7,765 | $ 1,978 |
License revenue [Member] | ||
Revenue: | ||
Revenue | $ 38 | $ 38 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock, Common [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2021 | $ 143 | $ 1,565,942 | $ (234) | $ (1,328,698) | $ 237,153 |
Balance (in shares) at Dec. 31, 2021 | 143,292,043 | 41,309 | |||
Issuance of common stock in connection with exercise of options | 125 | 125 | |||
Issuance of common stock in connection with exercise of options (in shares) | 30,411 | ||||
Issuance of restricted stock | $ 2 | (2) | |||
Issuance of restricted stock (in shares) | 1,852,626 | ||||
Forfeiture of restricted stock (in shares) | (591,746) | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 2,121 | 2,121 | |||
Net loss | (69,013) | (69,013) | |||
Balance at Mar. 31, 2022 | $ 145 | 1,568,186 | $ (234) | (1,397,711) | 170,386 |
Balance (in shares) at Mar. 31, 2022 | 144,583,334 | 41,309 | |||
Balance at Dec. 31, 2022 | $ 146 | 1,585,708 | $ (234) | (1,527,033) | $ 58,587 |
Balance (in shares) at Dec. 31, 2022 | 146,426,697 | 41,309 | |||
Treasury stock, balance (in shares) at Dec. 31, 2022 | 41,309 | ||||
Issuance of common stock in connection with exercise of options | 363 | $ 363 | |||
Issuance of common stock in connection with exercise of options (in shares) | 66,701 | ||||
Issuance of restricted stock | $ 3 | (3) | |||
Issuance of restricted stock (in shares) | 3,017,736 | ||||
Warrants issued with debt financing | 595 | 595 | |||
Forfeiture of restricted stock (in shares) | (73,787) | ||||
Compensation in respect of restricted stock granted to employees, directors and consultants | 7,120 | 7,120 | |||
Net loss | (39,232) | $ (39,232) | |||
Treasury stock, balance (in shares) at Mar. 31, 2023 | 41,309 | ||||
Balance at Mar. 31, 2023 | $ 149 | $ 1,593,783 | $ (234) | $ (1,566,265) | $ 27,433 |
Balance (in shares) at Mar. 31, 2023 | 149,437,347 | 41,309 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (39,232) | $ (69,013) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Noncash stock compensation expense | 6,823 | 2,121 |
Depreciation and amortization | 68 | 76 |
Amortization of premium (discount) on investment securities | (301) | 23 |
Amortization of debt issuance costs | 461 | 461 |
Amortization of leasehold interest | 53 | 53 |
Noncash change in lease liability and right of use asset | 491 | 683 |
Change in fair value of notes payable | 59 | (178) |
Changes in assets and liabilities: | ||
Increase in inventory | (26,924) | |
Decrease (increase) in other current assets | (2,623) | 6,759 |
Decrease (increase) in accounts receivable | (8,623) | 487 |
Increase (decrease) in accounts payable and accrued expenses | 9,858 | (10,170) |
Decrease in lease liabilities | (593) | (492) |
Increase in other current liabilities | 619 | 539 |
Decrease in deferred revenue | (38) | (38) |
Net cash used in operating activities | (59,902) | (68,689) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from maturity of short-term securities | 16,000 | 13,225 |
Investment in held-to-maturity securities | (22,168) | (56,889) |
Purchases of PPE | (7) | |
Net cash used in investing activities | (6,168) | (43,671) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Payment of loan payable | (975) | |
Proceeds from exercise of options | 363 | 125 |
Proceeds from debt financings | 25,000 | |
Financing costs paid | (125) | |
Net cash (used in) provided by financing activities | 25,238 | (850) |
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (40,832) | (113,210) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 103,577 | 300,151 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | $ 62,745 | $ 186,941 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Reconciliation to amounts on condensed consolidated balance sheets: | ||
Cash and cash equivalents | $ 61,469 | $ 185,676 |
Restricted cash | 1,276 | 1,265 |
Total cash, cash equivalents and restricted cash | 62,745 | 186,941 |
Cash paid for: | ||
Interest | $ 1,749 | $ 1,584 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2023 | |
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 diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI ® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 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, 2022. The accompanying condensed December 31, 2022 balance sheet has been derived from these statements. The results of operations for the three months ended March 31, 2023 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 March 31, 2023, we have an accumulated deficit of $1.6 billion. Our major sources of cash have been proceeds from private placement and public offering of equity securities, and from our loan and security agreements executed with Hercules Capital, Inc. (Hercules) (see Note 7 for more information). Since inception, we have incurred significant operating losses. Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. As of March 31, 2023, we had generated $7.8 million in revenue from drug sales of BRIUMVI. BRIUMVI first became commercially available in the United States in January of 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. As of March 31, 2023, we had $139.7 million in cash and cash equivalents, and investment securities. We anticipate that our cash, cash equivalents, and investment securities as of March 31, 2023, capital contractually available under our existing loan and security agreement, and forecasted revenue, will provide sufficient liquidity for more than a twelve-month period from the date of filing of this Quarterly Report on Form 10-Q. 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 2022 Annual Report on Form 10-K, except updated herein or as it relates to revenue recognition, accounts receivable, inventory, cost of product revenue, and the adoption of new accounting standards during the three months ended March 31, 2023. Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s consolidated financial statements. 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 we expect 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 - The Company recognizes product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance. 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: 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. 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. 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 BRIUMVI for credit under the following circumstances: ● ● ● ● ● As of March 31, 2023, the Company has not received any returns related to sales of BRIUMVI. Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, 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 March 31, 2023, 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 third-party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the costs of producing BRIUMVI sold to date was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of product revenue. 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 (FIFO). 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 BRIUMVI, all manufacturing and other potential costs related to the commercial launch of BRIUMVI 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, restricted stock, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The cumulative amounts of potentially dilutive securities excluded from the calculation were 14,209,749 and 12,657,717 for the three months ended March 31, 2023 and 2022, respectively. The following table summarizes our potentially dilutive securities at March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Unvested restricted stock 9,000,857 9,952,451 Options 4,876,484 2,423,991 Warrants 312,272 262,100 Shares issuable upon note conversion 20,136 19,175 Total 14,209,749 12,657,717 |
NET PRODUCT REVENUE
NET PRODUCT REVENUE | 3 Months Ended |
Mar. 31, 2023 | |
NET PRODUCT REVENUE | |
NET PRODUCT REVENUE | NOTE 2 NET PRODUCT REVENUE For the three months ended March 31, 2023 our only source of product revenue has been from U.S. sales of BRIUMVI which we began shipping to our customers in January 2023. For the three months ended March 31, 2022 our only source of product revenue was from the U.S. sales of UKONIQ, which we began shipping to our customers in February 2021. The voluntary withdrawal of UKONIQ from the U.S. market was announced on April 15, 2022. Effective May 31, 2022, UKONIQ was officially withdrawn from the market. As of March 31, 2023, approximately $1.9 million of estimated gross-to-net accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the condensed consolidated balance sheets. |
INVESTMENT SECURITIES
INVESTMENT SECURITIES | 3 Months Ended |
Mar. 31, 2023 | |
INVESTMENT SECURITIES | |
INVESTMENT SECURITIES | NOTE 3 INVESTMENT SECURITIES Our investments as of March 31, 2023 and December 31, 2022 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost. The following tables summarize our investment securities at March 31, 2023 and December 31, 2022: March 31, 2023 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 April 2023 and March 2024) (held-to-maturity) $ 78,241 $ 2 $ 951 $ 77,292 Total short-term investment securities $ 78,241 $ 2 $ 951 $ 77,292 December 31, 2022 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 2022 and April 2022) (held-to-maturity) $ 59,374 $ — $ 1,053 $ 58,321 Long-term investments: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity) 12,404 — 429 11,975 Total short-term and long-term investment securities $ 71,778 $ — $ 1,482 $ 70,296 |
INVENTORY
INVENTORY | 3 Months Ended |
Mar. 31, 2023 | |
INVENTORY | |
INVENTORY | NOTE 4 INVENTORY The following table presents our inventory as of March 31, 2023 (in thousands): March 31, 2023 Raw Materials $ 24 Work in Process 27,145 Finished Goods 52 Total Inventory $ 27,221 Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-process and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. At March 31, 2023, all of our inventory was related to BRIUMVI, which was approved by the FDA on December 28, 2022, at which time we began to capitalize costs to manufacture BRIUMVI. The Company has not recorded any inventory write downs since that time. Prior to the FDA approval of BRIUMVI, all costs related to the manufacturing of BRIUMVI and related material were charged to research and development expense in the period incurred. No costs related to the manufacturing of BRIUMVI and the related material were incurred between the approval date and year end 2022, therefore, inventory is not included in the December 31, 2022 condensed consolidated balance sheets. Inventory that is used for clinical development purposes is expensed to research and development expense when consumed. At March 31, 2023, we determined that a reserve related to BRIUMVI inventory is not required. We currently use a limited number of third-party contract manufacturing organizations (CMOs) to produce our inventory. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2023 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | NOTE 5 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. At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (Manhattan)) with Ariston Pharmaceuticals, Inc. (Ariston) in March 2010, Ariston issued $15.5 million of five-year 5% notes payable (the 5% Notes) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $1,125 per share. We have no obligations under the 5% Notes aside from the conversion feature. The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts receivable, accounts payable and loan payable. As of March 31, 2023 and December 31, 2022, the fair values of cash and cash equivalents, restricted cash, accounts receivable, and loan and interest payable approximate their carrying value. The carrying value of loan payable on the Company’s balance sheet is estimated to approximate its fair value as the interest rate approximates the market rate for loans with similar terms and risk characteristics. We have no Level 1 or Level 2 instruments. Our Level 3 instrument amounts represent the fair value of the 5% Notes and related accrued interest. The following table summarizes the changes in Level 3 instruments during the three months ended March 31, 2023: (in thousands) Balance at December 31, 2022 243 Interest accrued on face value of 5% Notes 270 Change in fair value of Level 3 liabilities (210) Balance at March 31, 2023 $ 303 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 | 3 Months Ended |
Mar. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | NOTE 6 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 2, 2022, we filed an automatic “shelf registration” statement on Form S-3 (the 2022 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 2022 WKSI Shelf was declared effective in September 2022. In connection with the 2022 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2022 ATM) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (each a 2022 Agent and collectively, the 2022 Agents), relating to the sale of shares of our common stock. Under the 2022 ATM, we will pay the 2022 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. We had no activity on the 2022 ATM during the three months ended March 31, 2023. The 2022 WKSI Shelf is currently our only active shelf-registration statement. We may offer any combination of the securities registered under the 2022 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 may need to file additional shelf-registration statements in the future to provide us with the flexibility to raise additional capital to finance our operations as needed. Equity Incentive Plans The TG Therapeutics, Inc. 2022 Incentive Plan (the 2022 Incentive Plan) was approved by stockholders in June 2022 with 17 million shares available to be issued, of which not more than 10 million shares may be issued pursuant to “full-value awards.” Full-value awards include any award other than an option or stock appreciation right and which is settled by the issuance of stock. As of March 31, 2023, 4,948,662 shares of restricted stock and 2,272,500 options were outstanding and up to an additional 9,247,521 shares were available to be issued under the 2022 Incentive Plan. The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020. As of March 31, 2023, 5,552,226 shares of restricted stock and 2,603,984 options were outstanding, and no additional shares were available to be issued under the 2012 Incentive Plan as the 2022 Incentive Plan is now the only active incentive plan. Stock-based compensation expense included in the condensed consolidated statements of operations was $6.8 million and $2.1 million for the three months ended March 31, 2023 and 2022, respectively. The $6.8 million for the three months ended March 31, 2023, is net of $0.3 million of stock-based compensation expense that was capitalized into inventory. Stock Options and Restricted Stock The following table summarizes the activity for stock options and restricted stock for the three months ended March 31, 2023: Stock Options Restricted Stock Equity awards outstanding, beginning of year 5,135,685 8,732,286 Changes during the year: Granted — 3,017,736 Exercised or vested (66,701) (1,175,347) Expired or Forfeited (192,500) (73,787) Equity awards outstanding, end of period 4,876,484 10,500,888 As of March 31, 2023, 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 $ 6,988 $ 51,264 Expected weighted-average period in years of compensation cost to be recognized 3.1 3.2 Warrants The Company’s only outstanding warrants are the warrants issued to Hercules as part of the Loan Agreement, the Amended Loan Agreement and the First Amendment (as such terms are defined below) to purchase 147,058, 115,042 and 50,172 shares of our common stock with exercise prices of $4.08, $17.95 and $14.70, respectively. See Note 7 for further details. There will not be any ongoing stock compensation expense volatility associated with these warrants. |
LOAN PAYABLE
LOAN PAYABLE | 3 Months Ended |
Mar. 31, 2023 | |
LOAN PAYABLE | |
LOAN PAYABLE | NOTE 7 LOAN PAYABLE On February 28, 2019 (the Closing Date), we entered into a term loan facility with Hercules Capital, Inc. (Hercules or Lender), which provided us with the capacity to borrow up to an aggregate principal amount of $60.0 million (Term Loan). 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 under the Term Loan was previously available upon the completion of different milestones and time points that have now lapsed. On December 30, 2021 (the Amended Loan Agreement Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules Capital, Inc. The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $60.0 million to $200.0 million (the Amended Term Loan), (ii) issue a first advance of $70.0 million drawn at the Amended Loan Agreement Closing Date, a portion of which was used to refinance the current outstanding loan balance of approximately $7.8 million and pay for expenses incurred by the Lender in executing the agreements, (iii) change the draw amounts and dates available in subsequent tranches, (iv) extend the maturity date of the facility from the original March 1, 2022 to January 1, 2026, (v) reset and extend the interest only period from April 1, 2021 to February 1, 2025 and extendable to August 1, 2025 subject to the achievement of certain performance milestones, and (vi) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 2.15%, and (b) 5.40%. In addition to the cash interest rate, the principal balance will accrue paid-in-kind interest at a rate of 3.45%, which amount will be capitalized and added to the outstanding principal balance of the Amended Term Loan and payable at the maturity date of the Amended Loan Agreement. The performance milestones are based on achievement of certain FDA approvals and impact the potential extension of the interest only period, access to future advances under the Loan Agreement and minimum cash levels required under the Amended Loan Agreement. The Amended Loan Agreement contains financial covenants from and after October 15, 2022 that require the Company to maintain certain levels of unrestricted cash and additional financial covenants related to market capitalization and unrestricted cash commencing on July 1, 2023 at any time when the Amended Term Loan advances made under the Amended Loan Agreement are greater than $70 million. On March 31, 2023 (the First Amendment Effective Date), the Company entered into a First Amendment to the Amended and Restated Loan and Security Agreement (the First Amendment) with Hercules. The First Amendment amended the terms of the Amended Loan Agreement to, among other things, (i) issue an advance of $25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) formal expiration of Tranche 2, (iii) change the draw amounts and dates available under subsequent tranches, including splitting the remaining balance of Tranche 3 into two additional advances in an aggregate principal amount of up to $20.0 million, in increments of $10.0 million (each a Tranche 3B Advance and Tranche 3C Advance), decreasing the amount available under Tranche 4 from $65.0 million to $60.0 million, and adding a Tranche 5 of $25.0 million, subject to the achievement of revenue related performance milestones, (iv) extend the interest only period from February 1, 2025 to August 1, 2025, and (v) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 1.20%, and (b) 8.95%. In addition to the cash interest rate, the principal balance will accrue paid-in-kind interest at a rate of 2.25%, which amount will be capitalized and added to the outstanding principal balance of the Amended Term Loan and payable at the maturity date of the Amended Loan Agreement. The First Amendment requires that the additional financial covenants referenced above apply at all times commencing on July 1, 2023. The First Amendment also contains warrant coverage of 2.95% of each advance amount funded. A warrant was issued by the Company to Hercules to purchase 50,172 shares of common stock with an exercise price of $14.70 for the amount funded pertaining to the Tranche 3A Advance (the First Amendment Warrant). The First Amendment Warrant shall be exercisable for seven years from the date of issuance. Hercules may exercise the First Amendment Warrant either by (a) cash or check or (b) through a net issuance conversion. In addition, the Company is required to pay a final payment fee equal to 5.95% of the aggregate principal amount of the Term Loan Advances (as defined in the Loan Agreement) plus 4.95% of the aggregate principal amount of all other advances. The Company may, at its option, prepay the Amended Term Loan in full or in part, subject to a prepayment penalty equal to (i) 1.5% of the principal amount prepaid if the prepayment occurs prior to the first anniversary of the First Amendment Effective Date, and (ii) 1.0% of the principal amount prepaid if the prepayment occurs on or after the first anniversary of the First Amendment Effective Date. The Company evaluated whether the First Amendment represented a debt modification or extinguishment of the Term Loan in accordance with ASC 470-50, Debt – Modifications and Extinguishments. As a result of the modification of terms and no repayment or retirement of the Term Loan, the Term Loan was accounted for by the Company under the modification accounting model. The Company capitalized the facility charge from the First Amendment advance to debt issuance costs and expensed third party fees in the Company’s statement of operations for the three months ended March 31, 2023. The Company estimated the fair value of the First Amendment Warrant using the Black-Scholes model based on the following key assumptions: Amended Term Loan Exercise price $ 14.70 Common share price on date of issuance $ 15.04 Volatility 0.88 % Risk-free interest rate 3.6 % Expected dividend yield — % Contractual term (in years) 7.00 years The Company incurred financing expenses of $2.0 million (including the fair value of the First Amendment Warrant) related to the First Amendment which are recorded as debt issuance costs and as an offset to loan payable on the Company’s consolidated balance sheet. The debt issuance costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and will be included in interest expense in the Company’s consolidated statements of operations. Amortization of debt issuance costs was $0.5 million for each of the three months ended March 31, 2023, and 2022, respectively. At March 31, 2023, the remaining unamortized balance of debt issuance costs was $7.0 million. The loan payable as of March 31, 2023 and December 31, 2022, is as follows: March 31, December 31, (in thousands) 2023 2022 Loan payable $ 95,000 $ 70,000 Add: Accreted Liability of final payment fee 8,532 6,667 103,532 76,667 Less: unamortized debt issuance costs (7,029) (5,532) 96,503 71,135 Less: principal payments — — Total loan payable 96,503 71,135 Less: current portion — — Loan payable non-current $ 96,503 $ 71,135 |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2023 | |
LEASES | |
LEASES | NOTE 8 LEASES In October 2014, we entered into an agreement (the Office Agreement) with Fortress Biotech, Inc. (FBIO) to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease. We approximate an average annual rental obligation of $1.8 million under the Office Agreement. We began to occupy this space in April 2016, with rental payments beginning in the third quarter of 2016. Also in connection with this Office Agreement, we have pledged $1.3 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 lease for office space in New Jersey (the NJ Lease). We approximate an average annual rental obligation of $0.3 million under the NJ Lease. We took possession of this space in October 2019, with rental payments beginning in November 2019. We incurred rental expense of $0.1 million for the three months ended March 31, 2023. In October 2021, we finalized a five-year lease for office space in North Carolina (the NC Lease). We approximate an average annual rental obligation of $0.2 million under the NC Lease. We took possession of this space in February 2022, with rental payments beginning in April 2022. We incurred rental expense of less than $0.1 million for the three months ended March 31, 2023. 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 $11.6 million and $8.7 million, respectively, as of March 31, 2023. 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 following components of lease expense are included in the Company’s condensed consolidated statements of operations for the three months ended March 31, 2023 and 2022: Three months ended March 31, (in thousands) 2023 2022 Operating lease cost $ 544 $ 514 Net lease cost $ 544 $ 514 As of March 31, 2023, the weighted-average remaining operating lease term was 6.3 years and the weighted-average discount rate for operating leases was 9.98%. Cash paid for amounts included in the measurement of operating lease liabilities during the three months ended March 31, 2023 was $0.6 million. The balance sheet classification of lease liabilities was as follows: March 31, December 31, (in thousands) 2023 2022 Liabilities Lease liability current portion $ 1,546 $ 1,581 Lease liability non-current 10,079 10,344 Total lease liability $ 11,625 $ 11,925 As of March 31, 2023, the maturities of lease liabilities were as follows: Operating (in thousands) leases Remainder of 2023 $ 1,782 2024 2,388 2025 2,100 2026 2,080 2027 1,913 After 2028 6,542 Total lease payments 16,805 Less: interest (5,180) Present value of lease liabilities(*) $ 11,625 (*) 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 through December 31, 2021. We used an incremental borrowing rate of 5.65% for the NC lease. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2023 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | NOTE 9 LICENSE AGREEMENTS BRIUMVI (Ublituximab) 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 of ublituximab (the LFB License Agreement). Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. As of March 31, 2023, we have incurred approximately $25.0 million in expense related to the achievement of certain milestones of the LFB License Agreement. LFB Group is eligible to receive future payments of up to an aggregate of approximately $18.0 million upon our successful achievement of certain regulatory 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. During the three months ended March 31, 2023, the Company recorded $0.8 million related to the worldwide royalty due under the LFB License Agreement in cost of product revenue based on U.S. sales of BRIUMVI and as of March 31, 2023, $0.8 million in royalties were payable under the LFB License Agreement. 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 March 31, 2023 and 2022, and at March 31, 2023 and December 31, 2022, have deferred revenue of approximately $0.4 million and $0.5 million, respectively, associated with this $2 million payment (approximately $0.2 million of which has been classified in current liabilities at March 31, 2023 and December 31, 2022). 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. UKONIQ (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. As of March 31, 2023, we have incurred approximately $24.0 million in expense related to the achievement of certain milestones of the Umbralisib License. Under the terms of the Umbralisib License, Rhizen is eligible to receive approval and sales-based milestone payments in the aggregate of approximately $175 million payable. Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib. During the year ended December 31, 2022, the Company recorded $0.2 million 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 December 31, 2022, approximately $3,000 in royalties were payable under the Umbralisib License. As of March 31, 2023, no royalties were payable under the Umbralisib License and as a result of the withdrawal of UKONIQ from the U.S. market and discontinuation of all commercialization activities, we do not expect to incur any additional costs related to this license agreement. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2023 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 10 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. The 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 March 31, 2023 and 2022, primarily related to shared personnel. Mr. Weiss, our Chairman and Chief Executive Officer, also serves as a director and Executive Vice Chairman, Strategic Development of FBIO. Please refer to Note 8 – Leases for details regarding the Office Agreement with FBIO. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2022. The accompanying condensed December 31, 2022 balance sheet has been derived from these statements. The results of operations for the three months ended March 31, 2023 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 March 31, 2023, we have an accumulated deficit of $1.6 billion. Our major sources of cash have been proceeds from private placement and public offering of equity securities, and from our loan and security agreements executed with Hercules Capital, Inc. (Hercules) (see Note 7 for more information). Since inception, we have incurred significant operating losses. Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. As of March 31, 2023, we had generated $7.8 million in revenue from drug sales of BRIUMVI. BRIUMVI first became commercially available in the United States in January of 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates. We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. As of March 31, 2023, we had $139.7 million in cash and cash equivalents, and investment securities. We anticipate that our cash, cash equivalents, and investment securities as of March 31, 2023, capital contractually available under our existing loan and security agreement, and forecasted revenue, will provide sufficient liquidity for more than a twelve-month period from the date of filing of this Quarterly Report on Form 10-Q. 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 we expect 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 - The Company recognizes product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance. 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: 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. 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. 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 BRIUMVI for credit under the following circumstances: ● ● ● ● ● As of March 31, 2023, the Company has not received any returns related to sales of BRIUMVI. Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, 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 March 31, 2023, 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 third-party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the costs of producing BRIUMVI sold to date was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of product revenue. |
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 (FIFO). 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 BRIUMVI, all manufacturing and other potential costs related to the commercial launch of BRIUMVI 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, restricted stock, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The cumulative amounts of potentially dilutive securities excluded from the calculation were 14,209,749 and 12,657,717 for the three months ended March 31, 2023 and 2022, respectively. The following table summarizes our potentially dilutive securities at March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Unvested restricted stock 9,000,857 9,952,451 Options 4,876,484 2,423,991 Warrants 312,272 262,100 Shares issuable upon note conversion 20,136 19,175 Total 14,209,749 12,657,717 |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2022 Annual Report on Form 10-K, except updated herein or as it relates to revenue recognition, accounts receivable, inventory, cost of product revenue, and the adoption of new accounting standards during the three months ended March 31, 2023. Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s consolidated financial statements. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of potentially dilutive securities | The following table summarizes our potentially dilutive securities at March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Unvested restricted stock 9,000,857 9,952,451 Options 4,876,484 2,423,991 Warrants 312,272 262,100 Shares issuable upon note conversion 20,136 19,175 Total 14,209,749 12,657,717 |
REVENUE RECOGNITION (Tables)
REVENUE RECOGNITION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
NET PRODUCT REVENUE | |
Reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments | For the three months ended March 31, 2023 our only source of product revenue has been from U.S. sales of BRIUMVI which we began shipping to our customers in January 2023. For the three months ended March 31, 2022 our only source of product revenue was from the U.S. sales of UKONIQ, which we began shipping to our customers in February 2021. The voluntary withdrawal of UKONIQ from the U.S. market was announced on April 15, 2022. Effective May 31, 2022, UKONIQ was officially withdrawn from the market. As of March 31, 2023, approximately $1.9 million of estimated gross-to-net accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the condensed consolidated balance sheets. |
INVESTMENT SECURITIES (Tables)
INVESTMENT SECURITIES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
INVESTMENT SECURITIES | |
Schedule of investment securities | The following tables summarize our investment securities at March 31, 2023 and December 31, 2022: March 31, 2023 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 April 2023 and March 2024) (held-to-maturity) $ 78,241 $ 2 $ 951 $ 77,292 Total short-term investment securities $ 78,241 $ 2 $ 951 $ 77,292 December 31, 2022 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 2022 and April 2022) (held-to-maturity) $ 59,374 $ — $ 1,053 $ 58,321 Long-term investments: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity) 12,404 — 429 11,975 Total short-term and long-term investment securities $ 71,778 $ — $ 1,482 $ 70,296 |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
INVENTORY | |
Schedule of Inventory | March 31, 2023 Raw Materials $ 24 Work in Process 27,145 Finished Goods 52 Total Inventory $ 27,221 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
FAIR VALUE MEASUREMENTS | |
Schedule of change in level three fair value during period | We have no Level 1 or Level 2 instruments. Our Level 3 instrument amounts represent the fair value of the 5% Notes and related accrued interest. The following table summarizes the changes in Level 3 instruments during the three months ended March 31, 2023: (in thousands) Balance at December 31, 2022 243 Interest accrued on face value of 5% Notes 270 Change in fair value of Level 3 liabilities (210) Balance at March 31, 2023 $ 303 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 three months ended March 31, 2023: Stock Options Restricted Stock Equity awards outstanding, beginning of year 5,135,685 8,732,286 Changes during the year: Granted — 3,017,736 Exercised or vested (66,701) (1,175,347) Expired or Forfeited (192,500) (73,787) Equity awards outstanding, end of period 4,876,484 10,500,888 |
Schedule of compensation cost related to unvested awards | As of March 31, 2023, 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 $ 6,988 $ 51,264 Expected weighted-average period in years of compensation cost to be recognized 3.1 3.2 |
LOAN PAYABLE (Tables)
LOAN PAYABLE (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
LOAN PAYABLE | |
Schedule of key assumptions | Amended Term Loan Exercise price $ 14.70 Common share price on date of issuance $ 15.04 Volatility 0.88 % Risk-free interest rate 3.6 % Expected dividend yield — % Contractual term (in years) 7.00 years |
Schedule of loan payable | The loan payable as of March 31, 2023 and December 31, 2022, is as follows: March 31, December 31, (in thousands) 2023 2022 Loan payable $ 95,000 $ 70,000 Add: Accreted Liability of final payment fee 8,532 6,667 103,532 76,667 Less: unamortized debt issuance costs (7,029) (5,532) 96,503 71,135 Less: principal payments — — Total loan payable 96,503 71,135 Less: current portion — — Loan payable non-current $ 96,503 $ 71,135 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
LEASES | |
Schedule of lease cost | Three months ended March 31, (in thousands) 2023 2022 Operating lease cost $ 544 $ 514 Net lease cost $ 544 $ 514 |
Schedule of classification of lease liabilities | March 31, December 31, (in thousands) 2023 2022 Liabilities Lease liability current portion $ 1,546 $ 1,581 Lease liability non-current 10,079 10,344 Total lease liability $ 11,625 $ 11,925 |
Schedule of lease liability maturity | As of March 31, 2023, the maturities of lease liabilities were as follows: Operating (in thousands) leases Remainder of 2023 $ 1,782 2024 2,388 2025 2,100 2026 2,080 2027 1,913 After 2028 6,542 Total lease payments 16,805 Less: interest (5,180) Present value of lease liabilities(*) $ 11,625 (*) 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 through December 31, 2021. We used an incremental borrowing rate of 5.65% for the NC lease. |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Revenue | $ 7,803 | $ 2,016 | |
Accumulated deficit | 1,566,265 | $ 1,527,033 | |
Cash and cash equivalents, and investment securities | 139,700 | ||
BRIUMVI (Ublituximab) | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Revenue | $ 7,800 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Computation of diluted loss per share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 14,209,749 | 12,657,717 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 9,000,857 | 9,952,451 |
Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 4,876,484 | 2,423,991 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 312,272 | 262,100 |
Share Issuable Upon Note Conversion [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from calculation | 20,136 | 19,175 |
NET PRODUCT REVENUE (Details)
NET PRODUCT REVENUE (Details) $ in Millions | Mar. 31, 2023 USD ($) |
NET PRODUCT REVENUE | |
Estimated amount of gross net accruals | $ 1.9 |
INVESTMENT SECURITIES - Summary
INVESTMENT SECURITIES - Summary of investment securities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Amortized cost, as adjusted | $ 78,241 | $ 71,778 |
Gross unrealized holding gains | 2 | |
Gross unrealized holding losses | 951 | 1,482 |
Estimated fair value | 77,292 | 70,296 |
Short-term Investments [Member] | Obligations of domestic governmental agencies [Member] | ||
Amortized cost, as adjusted | 78,241 | 59,374 |
Gross unrealized holding gains | 2 | |
Gross unrealized holding losses | 951 | 1,053 |
Estimated fair value | $ 77,292 | 58,321 |
Long-term investments [Member] | Obligations of domestic governmental agencies [Member] | ||
Amortized cost, as adjusted | 12,404 | |
Gross unrealized holding losses | 429 | |
Estimated fair value | $ 11,975 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Mar. 31, 2023 |
Inventory [Line Items] | ||
Raw Materials | $ 24 | |
Work in Process | 27,145 | |
Finished Goods | 52 | |
Total Inventory | $ 27,221 | |
BRIUMVI (Ublituximab) | ||
Inventory [Line Items] | ||
Costs related to BRIUMVI | $ 0 |
FAIR VALUE MEASUREMENTS - Manha
FAIR VALUE MEASUREMENTS - Manhattan Pharmaceuticals, Inc. (Details) - Manhattan and Ariston Pharmaceuticals Merger [Member] $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended |
Mar. 31, 2010 USD ($) item $ / shares | Mar. 31, 2023 | |
Fair Value Measurements | ||
Notes Issued | $ | $ 15.5 | |
Debt Instrument, Term | 5 years | |
Det instrument rate | 5% | 5% |
Debt Instrument convertible conversion price | $ / shares | $ 1,125 | |
Number of Obligations | item | 0 |
FAIR VALUE MEASUREMENTS - Summa
FAIR VALUE MEASUREMENTS - Summary of changes in Level 3 instruments (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
FAIR VALUE MEASUREMENTS | |
Balance at beginning of period | $ 243 |
Interest accrued on face value of 5% Notes | 270 |
Change in fair value of Level 3 liabilities | (210) |
Balance at end of period | $ 303 |
STOCKHOLDERS EQUITY - Preferred
STOCKHOLDERS EQUITY - Preferred Stock (Details) | Mar. 31, 2023 $ / shares shares |
STOCKHOLDERS' EQUITY | |
Preferred stock, shares authorized | shares | 10,000,000 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 |
STOCKHOLDERS EQUITY - Common St
STOCKHOLDERS EQUITY - Common Stock (Details) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 02, 2022 |
Common stock, shares authorized | 175,000,000 | 175,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
2022 ATM [Member] | |||
Percent of commission rate | 3% |
STOCKHOLDERS' EQUITY - Equity I
STOCKHOLDERS' EQUITY - Equity Incentive Plans (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2022 | |
Total expense associated with the stock options | $ 6,823 | $ 2,121 | |
Amended and Restated 2012 Incentive Plan [Member] | |||
Restricted stock outstanding | 5,552,226 | ||
Options outstanding | 2,603,984 | ||
Number of additional shares that may be issued | 0 | ||
Incentive Plan 2022 | |||
Approved shares available to be issued | 17,000,000 | ||
Restricted stock outstanding | 4,948,662 | ||
Options outstanding | 2,272,500 | ||
Number of additional shares that may be issued | 9,247,521 | ||
Incentive Plan 2022 | Maximum [Member] | |||
Approved shares available for issue pursuant to full-value awards | 10,000,000 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock option activity (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) shares | |
Restricted stock | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Equity awards outstanding, beginning of year | 8,732,286 |
Granted | 3,017,736 |
Exercised or vested | (1,175,347) |
Expired or Forfeited | (73,787) |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 10,500,888 |
Unrecognized compensation cost | $ | $ 51,264 |
Expected weighted-average period in years of compensation cost to be recognized | 3 years 2 months 12 days |
Stock options | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | |
Equity awards outstanding, beginning of year | 5,135,685 |
Exercised or vested | (66,701) |
Expired or Forfeited | (192,500) |
Equity awards outstanding, end of period | 4,876,484 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unrecognized compensation cost | $ | $ 6,988 |
Expected weighted-average period in years of compensation cost to be recognized | 3 years 1 month 6 days |
STOCKHOLDERS EQUITY - Warrants
STOCKHOLDERS EQUITY - Warrants (Details) - Warrants [Member] | Mar. 31, 2023 $ / shares shares |
Loan Agreement | |
Warrants Issued | shares | 147,058 |
Weighted average exercise price of warrants | $ / shares | $ 4.08 |
Amended Loan Agreement | |
Warrants Issued | shares | 115,042 |
Weighted average exercise price of warrants | $ / shares | $ 17.95 |
First Agreement Member | |
Warrants Issued | shares | 50,172 |
Weighted average exercise price of warrants | $ / shares | $ 14.70 |
LOANS PAYABLE (Details)
LOANS PAYABLE (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2023 USD ($) item $ / shares shares | Mar. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Feb. 28, 2019 USD ($) item | |
Debt Instrument [Line Items] | |||||
Paid in kind interest rate | 2.25% | ||||
Interest rate | 8.95% | 8.95% | |||
Additional advance under tranche | item | 2 | ||||
Final payment | 4.95% | ||||
Paid in kind interest rate | 3.45% | ||||
Amortization of Debt Issuance Costs | $ 461 | $ 461 | |||
Prime Rate [Member] | |||||
Debt Instrument [Line Items] | |||||
Spread added to rate ( as a percent) | 1.20% | ||||
Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Maximum term loan facility | $ 60,000 | $ 60,000 | |||
Amount of outstanding loan balance | 7,800 | ||||
Number of advances | item | 4 | ||||
Final payment fee (as a percentage) | 5.95% | ||||
Amount drawn on first advance | $ 70,000 | $ 70,000 | $ 30,000 | ||
Term Loan [Member] | Tranche Three | |||||
Debt Instrument [Line Items] | |||||
Amount of draw | 65,000 | 65,000 | |||
Term Loan [Member] | Tranche 3A Advance | |||||
Debt Instrument [Line Items] | |||||
Amount drawn on first advance | 25,000 | 25,000 | |||
Term Loan [Member] | Tranche 3B Advance | |||||
Debt Instrument [Line Items] | |||||
Amount of draw | 20,000 | 20,000 | |||
Term Loan [Member] | Tranche 3C Advance | |||||
Debt Instrument [Line Items] | |||||
Incremental amount | 10,000 | ||||
Term Loan [Member] | Tranche Four | |||||
Debt Instrument [Line Items] | |||||
Amount of draw | 60,000 | $ 60,000 | |||
Amended Loan Agreement | |||||
Debt Instrument [Line Items] | |||||
Maximum term loan facility | 200,000 | ||||
Amount drawn on first advance | $ 70,000 | ||||
Warrant Exercisable Term | 7 years | ||||
Financing expenses | $ 2,000 | ||||
Amortization of Debt Issuance Costs | 500 | ||||
Unamortized balance of debt | $ 7,000 | $ 7,000 | |||
Amended Loan Agreement | Prime Rate [Member] | |||||
Debt Instrument [Line Items] | |||||
Spread added to rate ( as a percent) | 2.15% | ||||
Amended Loan Agreement | Prime Rate [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Interest rate (as a percent) | 5.40% | ||||
Amended Loan Agreement | Warrants [Member] | |||||
Debt Instrument [Line Items] | |||||
Warrant Coverage Percentage | 2.95% | ||||
Warrants issued | shares | 50,172 | 50,172 | |||
Warrant purchase price | $ / shares | $ 14.70 | $ 14.70 | |||
Amended Loan Agreement | Debt Instrument, Prepayment Occurs Prior To First Anniversary Of First Amendment Effective Date | |||||
Debt Instrument [Line Items] | |||||
Prepayment charge (as a percent) | 1.50% | ||||
Amended Loan Agreement | Debt Instrument, Prepayment Occurs On Or After The First Anniversary Of First Amendment Effective Date | |||||
Debt Instrument [Line Items] | |||||
Prepayment charge (as a percent) | 1% |
LOANS PAYABLE - Estimated fair
LOANS PAYABLE - Estimated fair value of warrants (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares | |
Measurement Input, Expected Term [Member] | |
Contractual term (in years) | 7 years |
Warrants [Member] | Measurement Input, Exercise Price [Member] | |
Exercise price | $ 14.70 |
Warrants [Member] | Measurement Input, Share Price [Member] | |
Common share price on date of issuance | $ 15.04 |
Warrants [Member] | Measurement Input, Price Volatility [Member] | |
Volatility | 0.88% |
Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
Risk-free interest rate | 3.60% |
LOANS PAYABLE - Summary (Detail
LOANS PAYABLE - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
LOAN PAYABLE | ||
Loan payable | $ 95,000 | $ 70,000 |
Add: Accreted Liability of final payment fee | 8,532 | 6,667 |
Loan payable, gross | 103,532 | 76,667 |
Less: unamortized debt issuance costs | (7,029) | (5,532) |
Loan payable | 96,503 | 71,135 |
Total loan payable | 96,503 | 71,135 |
Loan payable non-current | $ 96,503 | $ 71,135 |
LEASES (Details)
LEASES (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Oct. 31, 2021 USD ($) | Oct. 31, 2019 USD ($) | Oct. 31, 2014 USD ($) ft² | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Feb. 28, 2019 | Jan. 01, 2019 USD ($) | |
Right of use assets | $ 8,689 | $ 8,888 | |||||
Operating Lease Liability | $ 11,625 | $ 11,925 | |||||
Lease additional term | 2 years | ||||||
Minimum [Member] | |||||||
Remaining lease term | 2 years | ||||||
Maximum [Member] | |||||||
Remaining lease term | 10 years | ||||||
Restatement Adjustment | |||||||
Right of use assets | $ 9,500 | ||||||
Operating Lease Liability | $ 8,100 | ||||||
Office Agreement [Member] | |||||||
Percentage Of Occupancy | 45% | ||||||
Area of Land | ft² | 24,000 | ||||||
Operating lease initial commitment period | 15 years | ||||||
Average Annual Rental Payments | $ 1,800 | ||||||
Additional collateral pledged | $ 1,300 | ||||||
Weighted-average discount rate for operating leases | 9.98% | 10.25% | |||||
Weighted-average remaining operating lease term | 6 years 3 months 18 days | ||||||
Operating Lease, Payments, Use | $ 600 | ||||||
NJ Lease [Member] | |||||||
Operating lease initial commitment period | 5 years | ||||||
Average Annual Rental Payments | $ 300 | ||||||
Rent expense | $ 100 | ||||||
NC Lease [Member] | |||||||
Operating lease initial commitment period | 5 years | ||||||
Average Annual Rental Payments | $ 200 | ||||||
Weighted-average discount rate for operating leases | 5.65% | ||||||
NC Lease [Member] | Maximum [Member] | |||||||
Rent expense | $ 100 |
LEASES - Components of lease ex
LEASES - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
LEASES | ||
Operating lease cost | $ 544 | $ 514 |
Net lease cost | $ 544 | $ 514 |
LEASES - Classification of leas
LEASES - Classification of lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
LEASES | ||
Lease liability current portion | $ 1,546 | $ 1,581 |
Lease liability non-current | 10,079 | 10,344 |
Total lease liability | $ 11,625 | $ 11,925 |
LEASES - Maturities of lease li
LEASES - Maturities of lease liabilities (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
LEASES | |
Remainder of 2023 | $ 1,782 |
2024 | 2,388 |
2025 | 2,100 |
2026 | 2,080 |
2027 | 1,913 |
After 2028 | 6,542 |
Total lease payments | 16,805 |
Less: Interest | (5,180) |
Present value of lease liabilities | $ 11,625 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2012 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2012 | Mar. 31, 2022 | Jun. 22, 2014 | |
BRIUMVI (Ublituximab) | ||||||
License Agreements | ||||||
Upfront fee | $ 2,000,000 | $ 2,000,000 | ||||
Income taxes | $ 300,000 | |||||
Term after first commercial sale | 15 years | 15 years | ||||
Deferred Revenue | $ 400,000 | $ 500,000 | ||||
License revenue | 38,000 | $ 38,000 | ||||
Deferred Revenue, Current | 200,000 | 200,000 | ||||
Expenses incurred | 25,000,000 | |||||
Additional payments on achievement of certain milestones | 18,000,000 | |||||
Accrued Royalties | 800,000 | |||||
BRIUMVI (Ublituximab) | Maximum [Member] | ||||||
License Agreements | ||||||
Potential milestones payable | 5,000,000 | |||||
UKONIQ (umbralisib) [Member] | ||||||
License Agreements | ||||||
Expenses incurred | 24,000,000 | |||||
Potential milestones payable | $ 175,000,000 | |||||
Accrued Royalties | $ 0 | |||||
Royalty Expense | 200,000 | |||||
Royalty payable | $ 3,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Shared Services Agreement [Member] | ||
Related Party Transaction [Line Items] | ||
Expenses incurred | $ 0.2 | $ 0.2 |