1 unchanged sentence
Evaluation of Disclosure Controls and Procedures.
−Removed: As of December 31, 2022, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act)).
+Added: As of December 31, 2023, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act)).
Our disclosure controls and procedures are designed to provide reasonable assurance that information we are required to disclose in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms.
14 unchanged sentences
OTHER INFORMATION.
+Added: Securities Trading Plans of Directors and Executive Officers
+Added: During the three months ended December 31, 2023, none of our directors or executive officers adopted or terminated a Rule 10b5 - 1 trading arrangement (as defined in Item 408 (a)( 1 )(i) of Regulation S-K) or adopted or terminated a non-Rule 10b5 - 1 trading arrangement (as defined in Item 408 (c) of Regulation S-K) for the purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c).
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
13 unchanged sentences
Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID:
−Removed: 185) (CohnReznick LLP, New York, NY, Audit Firm ID:
Consolidated Balance Sheets as of December 31, 2023 and 2022
83 unchanged sentences
2022 Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 23, 2022).
+Added: First Amendment to Amended and Restated Loan and Security Agreement, dated March 31, 2023, by and among TG Therapeutics, Inc., TG Biologics, Inc.
+Added: and Hercules Capital, Inc.
+Added: (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Capital Inc.
+Added: (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Funding IV, LLC.
+Added: (incorporated by reference to Exhibit 10.3 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Private Credit Fund 1 L.P.
+Added: (incorporated by reference to Exhibit 10.4 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Private Global Venture Growth Fund I L.P.
+Added: (incorporated by reference to Exhibit 10.5 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Capital Inc.
+Added: (incorporated by reference to Exhibit 10.6 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Private Credit Fund 1 L.P.
+Added: (incorporated by reference to Exhibit 10.7 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc.
+Added: and Hercules Private Global Venture Growth Fund I L.P.
+Added: (incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
+Added: Commercialization Agreement by and between TG Therapeutics, Inc.
+Added: and Neuraxpharm Pharmaceuticals, S.L., dated as of July 28, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2023).
+Added: License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc.
+Added: TG Therapeutics, Inc.
+Added: Insider Trading Policy #
Subsidiaries of TG Therapeutics, Inc.
Consent of Independent Registered Public Accounting Firm (KPMG, LLP).
−Removed: Consent of Independent Registered Public Accounting Firm (CohnReznick LLP).
Power of Attorney (included in signature page).
3 unchanged sentences
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: TG Therapeutics, Inc.
+Added: Clawback Policy #
The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in iXBRL (Inline eXtensible Business Reporting Language):
7 unchanged sentences
Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID:
−Removed: 185) (CohnReznick LLP, New York, NY, Audit Firm ID:
Consolidated Balance Sheets as of December 31, 2023 and 2022
8 unchanged sentences
We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc.
−Removed: and subsidiaries (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with U.S.
+Added: and subsidiaries (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated March 1, 2023 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February 29, 2024 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
Basis for Opinion
13 unchanged sentences
The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Liquidity and capital resources
−Removed: As discussed in Note 1 to the consolidated financial statements, the Company's sources of cash have primarily been proceeds from private placement and public offering of equity securities, and from its loan and security agreements.
−Removed: The Company has incurred operating losses since inception.
−Removed: The Company’s ability to achieve profitability depends on its ability to generate revenue and many other internal and external factors.
−Removed: The Company may continue to incur substantial operating losses even if the Company begins to generate revenue from its drug candidates.
−Removed: The Company believes that its cash and cash equivalents, investment securities, capital contractually available under its existing Amended Loan Agreement, and forecasted revenue will provide the Company with sufficient liquidity for more than a twelve-month period from the date the consolidated financial statements are issued.
−Removed: As of December 31, 2022, the Company had $174.1 million in cash and cash equivalents, and investment securities, and $45.0 million of capital available under its Amended Loan Agreement.
−Removed: We identified the evaluation of the Company’s assessment of its liquidity and capital resources and related disclosures as a critical audit matter.
−Removed: Significant auditor judgment was required to evaluate the forecasted revenue used in the Company’s forecasted cash flows analysis for the twelve-month period subsequent to issuance of the consolidated financial statements.
+Added: Commercialization agreement with Neuraxpharm
+Added: As discussed in Note 2 to the consolidated financial statements, the Company entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.
+Added: (Neuraxpharm) that granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories.
+Added: The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI.
+Added: The consideration for these optional purchases of BRIUMVI by Neuraxpharm approximates the price that a customer in the territories would be willing to pay for these goods.
+Added: In 2023, the Company recognized a non-refundable upfront payment of $140.0 million as License Revenue related to the Commercialization Agreement.
+Added: We identified the evaluation of the accounting for the supply terms of the Commercialization Agreement with Neuraxpharm as a critical audit matter.
+Added: Specifically, complex auditor judgment was required to evaluate the Company’s assessment of whether the optional purchases of BRIUMVI granted a material right to Neuraxpharm, due to the complexity of evaluating whether the contractual pricing is commensurate with standalone selling price.
The following are the primary procedures we performed to address this critical audit matter.
−Removed: We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s assessment of its ability to continue as a going concern, including the development of the forecasted revenue over the twelve-month period following the date the consolidated financial statements are issued.
−Removed: To assess the Company’s ability to forecast revenue, we compared the Company's forecasted revenue with available external industry data and other internal information.
−Removed: We performed sensitivity analyses over the Company’s going concern assessment by evaluating the effect of changes to the forecasted revenue.
−Removed: We evaluated the reasonableness of the Company’s forecasted revenue by comparing it to management’s stated plans which were corroborated by meeting minutes of the Board of Directors.
−Removed: We assessed the Company’s disclosures related to its going concern assessment by comparing the disclosures to the audit evidence obtained.
+Added: We evaluated the design and tested the operating effectiveness of an internal control in the Company’s revenue process used to evaluate key terms of contracts with customers, including the evaluation of the standalone selling price of BRIUMVI.
+Added: We obtained an understanding of the Commercialization Agreement by reading the contracts and conducting meetings with Company personnel responsible for negotiating the contracts.
+Added: We evaluated management’s accounting conclusions with respect to the supply terms within the Commercialization Agreement.
+Added: We recalculated the contractual price of the optional purchases and inspected the Company’s analysis of the standalone selling price of BRIUMVI using an expected cost plus a margin approach.
+Added: We obtained and inspected both external and internal evidence used by the Company in its analysis of the standalone selling price and compared this evidence to available industry information for the relevant territories.
+Added: We also performed a sensitivity analysis to evaluate the impact that a change in margin would have on the conclusion that the contractual pricing of optional purchases of BRIUMVI is commensurate with standalone selling price.
We have served as the Company’s auditor since 2021.
New York, New York
−Removed: March 1, 2023
+Added: February 29, 2024
Report of Independent Registered Public Accounting Firm
5 unchanged sentences
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements), and our report dated March 1, 2023 expressed an unqualified opinion on those consolidated financial statements.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements), and our report dated February 29, 2024 expressed an unqualified opinion on those consolidated financial statements.
Basis for Opinion
16 unchanged sentences
New York, New York
−Removed: March 1, 2023
−Removed: Report of Independent Registered Public Accounting Firm
−Removed: To the Board of Directors and Stockholders
−Removed: TG Therapeutics, Inc.
−Removed: Opinion on th e Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated statements of operations, stockholders’ equity and cash flows of TG Therapeutics, Inc.
−Removed: (the “Company”) for the period ended December 31, 2020, and the related notes (collectively referred to as the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the results of its operations and its cash flows for the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
−Removed: Basis for Opinion
−Removed: These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audit in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
−Removed: /s/ CohnReznick LLP
−Removed: We served as the Company’s auditor from 2003 to 2020.
−Removed: New York, New York
−Removed: March 1, 2021
+Added: February 29, 2024
TG Therapeutics, Inc.
4 unchanged sentences
Cash and cash equivalents
+Added: $ 92,933 $ 102,304
Short-term investment securities
+Added: 124,575 59,374
Accounts receivable, net
2 unchanged sentences
Total current assets
+Added: 317,943 168,274
Restricted cash
3 unchanged sentences
Equipment, net
+Added: $ 329,587 $ 193,572
Liabilities and stockholders’ equity
1 unchanged sentence
Accounts payable and accrued expenses
+Added: $ 38,471 $ 42,019
Other current liabilities
−Removed: Loan payable – current portion
Lease liability – current portion
1 unchanged sentence
Total current liabilities
−Removed: Deferred revenue, net of current portion
−Removed: Loan payable – non-current
+Added: 53,720 53,201
+Added: Deferred revenue
+Added: 100,118 71,135
Lease liability – non-current
Total liabilities
+Added: 169,085 134,985
Commitments and contingencies
2 unchanged sentences
Additional paid-in capital
+Added: 1,674,946 1,585,708
Treasury stock, at cost, 41,309 shares at December 31, 2023 and December 31, 2022
−Removed: Accumulated deficit
( 234 ) ( 234 )
+Added: Accumulated deficit
( 1,514,361 ) ( 1,527,033 )
Total stockholders’ equity
+Added: 160,502 58,587
Total liabilities and stockholders’ equity
+Added: $ 329,587 $ 193,572
The accompanying notes are an integral part of the consolidated financial statements.
4 unchanged sentences
Product revenue, net
−Removed: License revenue
+Added: License, milestone and other revenue
Total revenue
Costs and expenses:
−Removed: Cost of product revenue
+Added: Cost of revenue
Research and development:
7 unchanged sentences
Total costs and expenses
−Removed: Operating loss
+Added: Operating income (loss)
Other expense (income):
1 unchanged sentence
Total other expense (income), net
−Removed: Basic and diluted net loss per common share
−Removed: Weighted-average shares used in computing basic and diluted net loss per common share
+Added: Net income (loss) before taxes
+Added: Net income (loss)
+Added: Net income (loss) per common share:
+Added: Weighted-average shares outstanding:
The accompanying notes are an integral part of the consolidated financial statements.
5 unchanged sentences
Balance at January 1, 2021
+Added: 140,617,606 141 1,500,040 41,309 ( 234 ) ( 980,597 ) 519,350
Issuance of common stock in connection with exercise of options
+Added: 52,694 * 216 — — — 216
Issuance of restricted stock
+Added: 2,738,974 2 ( 2 ) — — — —
+Added: Warrants issued with debt financing
+Added: — — 2,195 — — — 2,195
Forfeiture of restricted stock
−Removed: Issuance of common stock in offerings (net of offering costs of $ 29.9 million)
+Added: ( 189,231 ) * — — — — —
+Added: Offering Costs Paid
+Added: — — ( 204 ) — — — ( 204 )
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.1 million)
+Added: 72,000 * 2,423 — — — 2,423
Compensation in respect of restricted stock granted to employees, directors and consultants
+Added: — — 61,274 — — — 61,274
+Added: Net income (loss)
+Added: — — — — — ( 348,101 ) ( 348,101 )
Balance at December 31, 2021
+Added: 143,292,043 143 1,565,942 41,309 ( 234 ) ( 1,328,698 ) 237,153
Issuance of common stock in connection with exercise of options
+Added: 142,409 * 584 — — — 584
Issuance of restricted stock
−Removed: Warrants issued with debt financing
+Added: 5,179,201 5 ( 5 ) — — — —
Forfeiture of restricted stock
−Removed: Offering Costs Paid
−Removed: Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.1 million)
+Added: ( 2,186,956 ) ( 2 ) 2 — — — —
Compensation in respect of restricted stock granted to employees, directors and consultants
+Added: — — 19,185 — — — 19,185
+Added: Net income (loss)
+Added: — — — — — ( 198,335 ) ( 198,335 )
Balance at December 31, 2022
1 unchanged sentence
Issuance of common stock in connection with exercise of options
+Added: 246,156 — 1,534 — — — 1,534
Issuance of restricted stock
+Added: 3,620,237 4 ( 4 ) — — — —
+Added: Warrants issued with debt financing
+Added: — — 595 — — — 595
Forfeiture of restricted stock
( 213,192 ) — — — — — —
+Added: Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.8 million)
+Added: 1,385,700 1 46,295 — — — 46,296
Compensation in respect of restricted stock granted to employees, directors and consultants
+Added: — — 40,818 — — — 40,818
+Added: Net income (loss)
+Added: — — — — — 12,672 12,672
Balance at December 31, 2023
7 unchanged sentences
CASH FLOWS FROM OPERATING ACTIVITIES
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Net income (loss)
+Added: $ 12,672 $ ( 198,335 ) $ ( 348,101 )
+Added: Adjustments to reconcile net income (loss) to net cash used in operating activities:
Noncash stock compensation expense
+Added: 37,933 19,185 61,274
Depreciation and amortization
Amortization of premium (discount) on investment securities
+Added: ( 2,236 ) ( 331 ) 517
Amortization of debt issuance costs
+Added: 2,378 1,844 1,080
Amortization of leasehold interest
Noncash change in lease liability and right of use asset
+Added: 1,963 2,715 1,896
Change in fair value of notes payable
+Added: 113 ( 116 ) ( 578 )
Changes in assets and liabilities:
+Added: Increase in inventory
+Added: ( 36,938 ) — —
Decrease (increase) in other current assets
+Added: ( 2,831 ) 8,181 ( 8,508 )
Decrease (increase) in accounts receivable
+Added: ( 51,093 ) 1,389 ( 1,389 )
(Decrease) increase in accounts payable and accrued expenses
+Added: 192 ( 11,010 ) 15,991
Decrease in lease liabilities
+Added: ( 2,375 ) ( 2,332 ) ( 2,012 )
Increase (decrease) in other current liabilities
−Removed: Decrease in deferred revenue
+Added: 2,675 2,277 ( 16,146 )
+Added: Increase (decrease) in deferred revenue
+Added: 5,711 ( 152 ) ( 152 )
Net cash used in operating activities
+Added: ( 31,413 ) ( 176,170 ) ( 295,634 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from maturity of short-term securities
+Added: 96,229 87,275 55,600
Investment in held-to-maturity securities
+Added: ( 146,880 ) ( 107,274 ) ( 55,531 )
Purchases of PPE
+Added: — ( 14 ) ( 401 )
Net cash used in investing activities
+Added: ( 50,651 ) ( 20,013 ) ( 332 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of loan payable
+Added: — ( 975 ) ( 30,000 )
Proceeds from sale of common stock, net
+Added: 46,296 — 2,219
Proceeds from exercise of options
+Added: 1,534 584 216
Proceeds from debt financings
−Removed: Offering costs paid
−Removed: Net cash (used in) provided by financing activities
−Removed: NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
+Added: 25,000 — 70,000
+Added: Financing costs paid
+Added: ( 125 ) — ( 1,016 )
+Added: Net cash provided by (used in) financing activities
+Added: 72,705 ( 391 ) 41,419
+Added: NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
+Added: ( 9,359 ) ( 196,574 ) ( 254,547 )
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD
+Added: 103,577 300,151 554,698
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
+Added: $ 94,218 $ 103,577 $ 300,151
Reconciliation to amounts on condensed consolidated balance sheets:
Cash and cash equivalents
+Added: $ 92,933 $ 102,304 $ 298,887
Restricted cash
+Added: 1,285 1,273 1,264
Total cash, cash equivalents and restricted cash
+Added: $ 94,218 $ 103,577 $ 300,151
Cash paid for:
+Added: 8,771 $ 5,445 $ 3,466
+Added: NONCASH TRANSACTIONS
+Added: Deferred Financing Costs
+Added: Warrants issued with debt financing
The accompanying notes are an integral part of the consolidated financial statements.
8 unchanged sentences
In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S.
−Removed: 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.
+Added: 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, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively.
We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
LIQUIDITY AND CAPITAL RESOURCES
−Removed: 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.
+Added: Historically, we have incurred operating losses since our inception;
+Added: however, the Company experienced a net profit during the twelve months ended December 31, 2023 due to a $ 140.0 million non-refundable upfront payment recognized as license revenue in the third quarter of 2023 as part of our ex-U.S.
+Added: commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L.
+Added: (Neuraxpharm) (see Note 2 for more information).
+Added: We expect to continue to incur operating losses in the near term and may never become profitable.
As of December 31, 2023, we have an accumulated deficit of $ 1.5 billion.
−Removed: 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.
−Removed: (Hercules) (see Note 6 for more information).
−Removed: Since inception, we have incurred significant operating losses.
+Added: Our major sources of cash have been proceeds from private placements and public offerings of equity securities, from our loan and security agreements executed with Hercules Capital, Inc.
+Added: (Hercules) (see Note 7 for more information), and the upfront payment from the Commercialization Agreement (see Note 2 for more information).
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.
−Removed: As of December 31, 2022, we had not yet generated revenue from drug sales of BRIUMVI.
+Added: As of December 31 2023, we had generated $ 92.0 million in product revenue from sales of BRIUMVI.
BRIUMVI first became commercially available in the United States in January of 2023.
−Removed: Even with the commercialization of BRIUMVI and the future commercialization of our other drug candidates, we may not become profitable.
−Removed: 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;
+Added: We also began shipping BRIUMVI to our ex-U.S.
+Added: licensing partner, Neuraxpharm, in November 2023.
+Added: Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable.
+Added: Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership;
successfully complete any post-approval regulatory obligations;
−Removed: and successfully commercialize our drug candidates alone or in partnership.
−Removed: We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates.
+Added: and our ability to maintain or obtain regulatory approval for our drug candidates.
+Added: We may continue to incur operating losses even now that we are generating revenues from BRIUMVI.
As of December 31, 2023, we had $ 217.5 million in cash and cash equivalents, and investment securities.
−Removed: We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2022, capital contractually available under our existing Amended Loan Agreement, and forecasted revenue, will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.
−Removed: The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our BRIUMVI 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.
−Removed: 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.
+Added: We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2023, combined with projected revenues associated with the sale of BRIUMVI in the U.S.
+Added: and ex-U.S., will provide sufficient liquidity for more than a twelve -month period from the date of filing this Annual Report on Form 10 -K.
+Added: The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates.
+Added: We may be 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.”
RECENTLY ISSUED ACCOUNTING STANDARDS
−Removed: Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have an effect on the Company’s financial statements.
+Added: 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 financial statements.
TG Therapeutics, Inc.
26 unchanged sentences
REVENUE RECOGNITION
−Removed: 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.
+Added: 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.
8 unchanged sentences
Variable consideration includes the following components, which are described below:
−Removed: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance.
+Added: chargebacks, government rebates, trade discounts and allowances, commercial payer rebates, 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).
4 unchanged sentences
If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.
−Removed: 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.
−Removed: 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:
2 unchanged sentences
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.
−Removed: GPO and Payor Rebates:
−Removed: 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.
−Removed: 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:
1 unchanged sentence
In addition, the Company also receives sales order management, inventory management, and data services from its customers in exchange for certain fees.
+Added: Commercial Payer Rebates:
+Added: The Company contracts with various private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of our product and contracted formulary status.
+Added: 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.
Product Returns:
2 unchanged sentences
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.
−Removed: Subject to certain limitations, the Company’s return policy allows for eligible returns of UKONIQ for credit under the following circumstances:
+Added: Subject to certain limitations, the Company’s return policy allows for eligible returns of commercial products sold for credit under the following circumstances:
receipt of damaged product;
6 unchanged sentences
Notes to Consolidated Financial Statements
−Removed: As of December 31, 2022, the Company has received $ 0.6 million in returns as a result of the market withdrawal of UKONIQ.
+Added: As of December 31, 2023 , the Company has not received any returns related to sales of BRIUMVI.
Co-Payment Assistance Programs:
−Removed: 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.
+Added: 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.
+Added: License Agreements –
+Added: The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products.
+Added: Such agreements may include the transfer of intellectual property rights in the form of licenses.
+Added: Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones, and royalties on sales of products.
+Added: Licenses of intellectual property:
+Added: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license.
+Added: All other promised goods or services in the agreement are evaluated to determine if they are distinct.
+Added: If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct.
+Added: Milestone payments:
+Added: Contingent milestones at contract inception are estimated at the amount which is not probable of a material reversal and included in the transaction price using the most likely amount method.
+Added: Milestone payments that are not within the Company's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained.
+Added: The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied.
+Added: At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that may not be subject to a material reversal and, if necessary, adjust the estimate of the overall transaction price.
+Added: Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
+Added: Sales-based royalties:
+Added: For arrangements that include sales-based royalties and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of when the related sales occur or when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied).
+Added: Optional Purchases:
+Added: The Company’s arrangements may provide the licensee the right to make optional purchases of the licensed product.
+Added: These optional purchases are accounted for as separate contracts when the licensee determines that it will make such a purchase, unless the option conveys a material right.
+Added: Other Revenue
+Added: Revenue is also generated from service-based fees recognized for providing regulatory support and development services to customers.
+Added: Service fee revenue is recognized overtime as the services are transferred to the customer.
+Added: DEFERRED PRODUCT REVENUE
+Added: When consideration is received, or such consideration is unconditionally due, from a customer prior to the Company completing its performance obligation to the customer under the terms of a contract, a contract liability is recorded as deferred revenue.
+Added: Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities.
+Added: Deferred revenues not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as long-term liabilities.
ACCOUNTS RECEIVABLE
2 unchanged sentences
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.
−Removed: As of December 31, 2022, due to the product withdrawal in April of 2022, there are no outstanding net receivables from customers.
−Removed: COST OF PRODUCT REVENUE
−Removed: 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.
−Removed: 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 year ended December 31, 2022 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.
+Added: As of December 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.
+Added: COST OF REVENUE
+Added: Cost of revenue consists primarily of third -party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales.
+Added: Cost of revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances.
+Added: 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 FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue.
+Added: Our cost of revenue also relates to providing regulatory support & development services to customers.
+Added: Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first -in- first -out method (FIFO).
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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
RESEARCH AND DEVELOPMENT COSTS
9 unchanged sentences
These agreements often require payments in advance of services performed or goods received.
−Removed: Accordingly, as of December 31, 2022 and December 31, 2021, we recorded approximately $ 4.2 million and $ 11.9 million, respectively, in prepaid research and development related to such advance agreements.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
+Added: Accordingly, as of December 31, 2023 and December 31, 2022 , we recorded approximately $ 4.2 million in prepaid research and development related to such advance agreements.
Income taxes are accounted for under the asset and liability method.
9 unchanged sentences
Refer to Note 9 for further information on impact of tax reform.
−Removed: The Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act) was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States.
−Removed: There are several provisions of the CARES Act that were considered in the December 31, 2022 year-end tax provision.
−Removed: However, the Company chose not to utilize any provisions or participate in certain programs due to lack of a benefit to the Company.
STOCK-BASED COMPENSATION
6 unchanged sentences
In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon achievement of certain milestones, the total expense is uncertain.
−Removed: Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones occurs.
+Added: Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable.
TG Therapeutics, Inc.
1 unchanged sentence
Notes to Consolidated Financial Statements
−Removed: BASIC AND DILUTED NET LOSS PER COMMON SHARE
−Removed: 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.
−Removed: Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented.
−Removed: The amounts of potentially dilutive securities excluded from the calculation were 12,650,658 , 13,280,608 and 11,976,276 at December 31, 2022, 2021 and 2020, respectively.
−Removed: During the years ended December 31, 2022, 2021 and 2020, the Company incurred a net loss;
−Removed: therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share.
+Added: NET INCOME (LOSS) PER COMMON SHARE
+Added: Basic net income (loss) per share of our common stock is calculated by dividing net income (loss) applicable to the common stock by the weighted-average number of our common stock outstanding for the period.
+Added: Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options, and restricted stock, which would result in the issuance of incremental shares of common stock.
+Added: The impact of these items is anti-dilutive during periods of net loss.
+Added: Therefore, basic and diluted net income (loss) per share were the same for all periods presented in the consolidated statement of operations, except for the year ended December 31, 2023, as the Company had net income for that period
The following table summarizes our potentially dilutive securities at December 31, 2023, 2022 and 2021 :
Unvested restricted stock
+Added: 8,139,037 7,232,254 10,532,029
+Added: 4,697,029 5,135,685 2,467,537
+Added: 312,272 262,100 262,100
Shares issuable upon note conversion
+Added: 20,902 20,619 18,942
+Added: 13,169,240 12,650,658 13,280,608
+Added: The computation of basic and diluted earnings per share (EPS) is as follows:
+Added: (in thousands, except share and per share data)
+Added: Net income (loss)
+Added: 12,672 ( 198,335 ) ( 348,101 )
+Added: Weighted-average common shares outstanding
+Added: 141,955,112 135,411,258 132,222,753
+Added: Dilutive effect of potential common shares
+Added: 6,553,353 - -
+Added: Weighted-average common shares outstanding assuming dilution
+Added: 148,508,465 135,411,258 132,222,753
+Added: Net income (loss) per share - basic
+Added: 0.09 ( 1.46 ) ( 2.63 )
+Added: Net income (loss) per share - diluted
+Added: 0.09 ( 1.46 ) ( 2.63 )
LONG-LIVED ASSETS AND GOODWILL
3 unchanged sentences
If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized.
−Removed: Goodwill is reviewed for impairment annually, or earlier when events arise that could indicate that an impairment exists.
−Removed: We test for goodwill impairment using a two-step process.
−Removed: The first step compares the fair value of the reporting unit with the unit’s carrying value, including goodwill.
−Removed: When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any.
−Removed: In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill.
−Removed: If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value.
−Removed: We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable.
−Removed: There was no impairment to goodwill as of December 31, 2022.
+Added: Goodwill results from excess consideration in a business combination over the fair value of identifiable net assets acquired.
+Added: Goodwill is not amortized but is reviewed for impairment at least annually, or more frequently if impairment indicators are present, by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount.
+Added: If we conclude it is more likely than not that the fair value is less than the carrying amount, a quantitative test that compares the fair value to its carrying value is performed to determine the amount of any impairment.
+Added: All leases with a lease term greater than 12 months, regardless of lease type classification, are recorded as an obligation on the balance sheet with a corresponding right-of-use asset.
+Added: Operating leases are reflected as lease liabilities on the commencement date of the lease based on the present value of the lease payments to be made over the lease term.
+Added: Current operating lease liabilities are reflected in lease liabilities – current portion and noncurrent operating lease liabilities are reflected in lease liabilities – non-current on the consolidated balance sheet.
+Added: Right-of-use assets are valued at the initial measurement of the lease liability, plus any initial direct costs or rent prepayments, minus lease incentives and any deferred lease payments.
+Added: Operating lease right-of-use assets are recorded right of use assets on the consolidated balance sheet and lease cost is recognized on a straight-line basis.
+Added: Leases with an initial term of 12 months or less are not recorded on the balance sheet and we recognize lease expense for these leases on a straight-line basis over the term of the lease.
+Added: In determining whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit.
+Added: NOTE 2 - REVENUE
+Added: As discussed in Note 1, revenues are recognized under guidance within ASC 606.
+Added: The following table presents our disaggregated revenue for the periods presented (in thousands):
+Added: (in thousands)
+Added: Year ended December 31,
+Added: Total product revenue, net
+Added: $ 92,005 2,633 6,537
+Added: License Revenue
+Added: 140,153 152 152
+Added: Other Revenue
+Added: Total Revenue
+Added: $ 233,662 $ 2,785 $ 6,689
TG Therapeutics, Inc.
1 unchanged sentence
Notes to Consolidated Financial Statements
−Removed: NOTE 2 - REVENUE RECOGNITION
−Removed: Gross-to-Net Sales Adjustments
−Removed: To date our only source of product revenue has been from the U.S.
−Removed: sales of UKONIQ, which we began shipping to our customers in February 2021.
−Removed: The voluntary withdrawal of UKONIQ from the U.S.
−Removed: market was announced on April 15, 2022.
−Removed: Effective May 31, 2022, UKONIQ was officially withdrawn from the market.
−Removed: We record our best estimate for sales discounts and allowances to which customers are likely to be entitled.
−Removed: The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the year ended December 31, 2022:
+Added: Product revenue, net
+Added: The following table presents our disaggregated revenue by product and geography for the periods presented:
(in thousands)
−Removed: Gross product revenue
−Removed: Gross-to-net adjustments:
−Removed: Chargebacks and administrative fees
−Removed: Trade discounts and allowances
−Removed: Government rebates and co-payment assistance
−Removed: Sales returns and allowances
−Removed: Total gross-to-net adjustments (1)
−Removed: Net product revenue
−Removed: (1) As of December 31, 2022 and 2021, approximately $ 0.2 million and $ 0.4 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 consolidated balance sheets.
+Added: Year ended December 31,
+Added: International
+Added: International
+Added: Total product revenue, net
+Added: International
+Added: We began shipping BRIUMVI to our U.S.
+Added: customers in January 2023.
+Added: We also began shipping BRIUMVI to our ex-U.S.
+Added: licensing partner, Neuraxpharm, in November 2023.
+Added: UKONIQ was voluntarily withdrawn from the U.S.
+Added: market effective May 31, 2022.
+Added: During 2023, approximately $ 9.2 million of gross-to-net accruals entirely related to U.S.
+Added: sales of BRIUMVI have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the condensed consolidated balance sheets.
+Added: License Agreements
+Added: Neuraxpharm Commercialization Agreement
+Added: On July 28, 2023, the Company entered into the Commercialization Agreement with Neuraxpharm.
+Added: The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada, and Mexico, the commercialization rights for which had been previously retained by the Company, thus excluding certain Asian countries subject to previously existing partnerships (the Territory).
+Added: In addition, the Company will perform certain development and regulatory activities for Neuraxpharm to support its obligations under the Commercialization Agreement to secure and maintain the regulatory approvals required to sell BRIUMVI in the Territory.
+Added: As part of the overall arrangement, the Company has agreed to supply BRIUMVI to Neuraxpharm throughout the term of the Commercialization Agreement.
+Added: In consideration for entering the Commercialization Agreement, the Company received a non-refundable upfront payment of $ 140.0 million.
+Added: The Company will also receive tiered double-digit royalties up to 30 % on net product sales in the Territory and is eligible to receive sales-based or other milestone payments totaling up to $ 505.0 million.
+Added: The Company evaluated the Commercialization Agreement under ASC 606 and concluded that Neuraxpharm represents a customer in the transaction.
+Added: In accordance with this guidance, the Company identified the following commitments under the arrangement:
+Added: (i) grant the exclusive right to develop, sell, offer to sell and import BRIUMVI in the Territory (the “License”);
+Added: and (ii) perform certain development and regulatory activities (“Development and Regulatory Activities”).
+Added: The License to the Company’s intellectual property represents a distinct performance obligation, therefore, the $ 140 million non-refundable upfront payment related to this performance obligation was recognized as License Revenue in 2023.
+Added: The Development and Regulatory Activities also represent a distinct performance obligation and are satisfied over time because Neuraxpharm simultaneously receives and consumes the benefits provided by the Company’s performance of the services.
+Added: Therefore, revenue is recognized as the activities are completed by the Company.
+Added: During 2023 the Company recognized Other Revenue of $ 1.5 million related to the Development and Regulatory Activities.
+Added: The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI (the “Supply of Licensed Product”).
+Added: These optional purchases are accounted for as a separate contract when the right to purchase BRIUMVI is exercised.
+Added: The consideration for optional purchases of BRIUMVI by Neuraxpharm approximates the price that a customer in the Territory would be willing to pay for these goods.
+Added: The performance obligation related to the Supply of Licensed Product is satisfied when control of the product passes to Neuraxpharm.
+Added: The consideration received from Neuraxpharm for the supply of BRIUMVI is recognized by the Company as a component of product revenue, net.
+Added: As of December 31, 2023, the Company has an unconditional right to receive $ 1.9 million in consideration from Neuraxpharm related to the performance obligation to supply BRIUMVI, which is recorded as accounts receivable, net.
+Added: A portion of the performance obligation to supply BRIUMVI has not yet been satisfied, therefore, as of December 31, 2023, $ 5.9 million has been recorded as deferred revenue.
+Added: During 2023 the Company recognized $ 3.2 million in BRIUMVI product sales, net related to performance obligations that were satisfied during the year ended December 31, 2023.
+Added: The Company will reevaluate the consideration received, and performance obligations satisfied at the end of each reporting period.
+Added: Such reevaluations may result in a change to the amount of product revenue, net, recognized and deferred revenue.
+Added: The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones.
+Added: The Company evaluated the constraint on variable consideration and concluded that the milestone payments are highly dependent on factors outside of the Company’s control.
+Added: Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur.
+Added: Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met.
+Added: All other milestones will be recognized as revenue immediately in the period the achievement of the underlying milestone is probable.
+Added: Any consideration related to sales-based royalties will be recognized when the related sales occur.
+Added: No royalty or milestone revenue was recognized during 2023.
TG Therapeutics, Inc.
10 unchanged sentences
Short-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between January 2023 and December 2023) (held-to-maturity)
−Removed: Long-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between January 2024 and February 2024) (held-to-maturity)
−Removed: Total short-term and long-term investment securities
+Added: Obligations of domestic governmental agencies (maturing between January 2024 and June 2024 ) (held-to-maturity)
+Added: $ 124,575 $ 30 $ 53 $ 124,552
+Added: Total short-term investment securities
+Added: $ 124,575 $ 30 $ 53 $ 124,552
December 31, 2022
−Removed: Estimated fair
holding gains
1 unchanged sentence
Short-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between January 2022 and April 2022) (held-to-maturity)
+Added: Obligations of domestic governmental agencies (maturing between January 2023 and December 2023 ) (held-to-maturity)
+Added: $ 59,374 $ — $ 1,053 $ 58,321
Long-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity)
+Added: Obligations of domestic governmental agencies (maturing between January 2024 and February 2024 ) (held-to-maturity)
+Added: 12,404 — 429 11,975
Total short-term and long-term investment securities
+Added: $ 71,778 $ — $ 1,482 $ 70,296
+Added: NOTE 4 – INVENTORY
+Added: The following table presents our inventory as of December 31, 2023 ( in thousands):
+Added: December 31, 2023
+Added: Raw Materials
+Added: Work in Process
+Added: Finished Goods
+Added: Total Inventory
+Added: Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-process and finished goods.
+Added: Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods.
+Added: At December 31,2023, all 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.
+Added: Prior to 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.
+Added: 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 consolidated balance sheet.
+Added: Inventory that is used for clinical development purposes is expensed to research and development expense when consumed.
+Added: For December 30, 2023 we determined that a reserve related to BRIUMVI inventory is not required.
NOTE 5 – FAIR VALUE MEASUREMENTS
4 unchanged sentences
Level 3 – unobservable inputs that are not corroborated by market data.
−Removed: As of December 31, 2022 and 2021, the fair values of cash and cash equivalents, restricted cash, accounts receivable, and notes and interest payable approximate their carrying value.
At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc.
9 unchanged sentences
(in thousands)
+Added: $ — $ — $ 357 $ 357
+Added: $ — $ — $ 357 $ 357
Financial liabilities at fair value as of December 31, 2022
+Added: $ — $ — $ 243 $ 243
+Added: $ — $ — $ 243 $ 243
The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest.
−Removed: The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts receivable, accounts payable and debt.
−Removed: 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.
+Added: The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts receivable, accounts payable and loan payable.
+Added: As of December 31, 2023 and 2022, the fair values of cash and cash equivalents, restricted cash, accounts receivable, and loan and interest payable approximate their carrying value.
+Added: 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.
+Added: We have no Level 1 or Level 2 instruments.
+Added: 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 for the years ended December 31, 2023 and 2022 :
36 unchanged sentences
During the year ended December 31, 2021, we sold a total of 72,000 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $ 2.5 million at an average selling price of $ 34.25 per share, resulting in net proceeds of approximately $ 2.4 million after deducting commissions and other transactions costs.
−Removed: During the year ended December 31, 2020, we sold a total of 804,100 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $ 33.9 million at an average selling price of $ 42.18 per share, resulting in net proceeds of approximately $ 33.3 million after deducting commissions and other transactions costs.
−Removed: During the year ended December 31, 2021, we sold a total of 72,000 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $ 2.5 million at an average selling price of $ 34.25 per share, resulting in net proceeds of approximately $ 2.4 million after deducting commissions and other transactions costs.
−Removed: In May 2020, we completed an underwritten public offering of 8,500,000 shares of our common stock (plus an underwriter option to purchase up to an additional 1,275,000 shares of common stock, which was exercised) at a price of $ 18 per share.
−Removed: Net proceeds from this offering, including the overallotment, were approximately $ 165.1 million, net of underwriting discounts and offering expenses of approximately $ 10.8 million.
−Removed: On December 17, 2020, we completed a public offering of 6,320,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 948,000 shares of common stock, which was exercised) at a price of $ 43.50 per share.
−Removed: Net proceeds from this offering, including the overallotment, were approximately $ 297.2 million after underwriting discounts and offering expenses of approximately $ 19.0 million.
TG Therapeutics, Inc.
8 unchanged sentences
The 2022 ATM has replaced the 2021 ATM as the only active ATM program.
−Removed: We had no activity on the 2021 ATM or 2022 ATM during the year ended December 31, 2022.
+Added: During the year ended December 31, 2023, we sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $ 47.1 million at an average selling price of $ 34.01 per share, resulting in net proceeds of approximately $ 46.3 million after deducting commissions and other transactions costs.
The 2022 WKSI Shelf is currently our only active shelf-registration statement.
10 unchanged sentences
As of December 31, 2023 , 5,007,864 shares of restricted stock and 2,424,529 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.
+Added: Total stock-based compensation expense included in the consolidated statements of operations was $ 37.9 million, $ 19.2 million and $ 61.3 million during the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The $ 37.9 million is net of $ 2.9 million of stock-based compensation expense that was capitalized into inventory during the year ended December 31, 2023.
TG Therapeutics, Inc.
7 unchanged sentences
Outstanding at January 1, 2021
+Added: 2,526,166 6.99 8.10 $ 115,472,832
+Added: ( 52,694 ) 4.10
+Added: ( 5,935 ) 4.10
Outstanding at December 31, 2021
+Added: 2,467,537 $ 7.06 6.99 $ 29,503,551
+Added: 2,975,000 7.00
+Added: ( 142,409 ) 4.10
+Added: ( 164,443 ) 7.84
Outstanding at December 31, 2022
+Added: 5,135,685 $ 7.10 5.09 $ 25,064,799
+Added: ( 246,156 ) 6.08
+Added: ( 192,500 ) 11.30
Outstanding at December 31, 2023
+Added: 4,697,029 $ 6.98 4.10 $ 47,607,209
Exercisable at December 31, 2023
−Removed: Total ex pense associated with the stock options was approximately $ 3.3 million, $ 2.9 million and $ 6.0 million during the years ended December 31, 2022, 2021 and 2020, respectively.
+Added: 2,133,273 $ 6.60 4.72 $ 22,518,984
+Added: Total expense associated with stock options was approximately $ 3.9 million, $ 3.3 million and $ 2.9 million during the years ended December 31, 2023, 2022 and 2021 , respectively.
As of December 31, 2023 , there was approximately $ 4.1 million of total unrecognized compensation cost related to unvested time-based stock options, which is expected to be recognized over a weighted-average period of 2.6 years.
As of December 31, 2023 , the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based.
−Removed: Stock-based compensation for milestone-based options will be recorded if and when a milestone occurs.
−Removed: We recognized stock-based compensation expense of $ 1.2 million during the year ended December 31, 2022 for these stock options.
+Added: Stock-based compensation for milestone-based options will be recorded if and when a milestone becomes probable.
+Added: We did not recognize stock-based compensation expense during the year ended December 31, 2023 for these stock options.
TG Therapeutics, Inc.
5 unchanged sentences
December 31, 2021
−Removed: 88.37 - 89.67
−Removed: 186.91 - 191.05
+Added: N/A 88.37 - 89.67 % N/A
Expected term (in years)
+Added: N/A 3.13 - 4.0 N/A
Risk-free rate
+Added: N/A 2.99 - 3.35 % N/A
Expected dividend yield
8 unchanged sentences
10,785,034 13.38
+Added: 2,738,974 39.49
+Added: ( 1,302,737 ) 18.14
+Added: ( 189,231 ) 21.80
Outstanding at December 31, 2021
12,032,040 18.67
+Added: 5,179,201 12.75
+Added: ( 6,291,999 ) 11.28
+Added: ( 2,186,956 ) 22.44
Outstanding at December 31, 2022
1 unchanged sentence
3,620,237 13.77
+Added: ( 2,500,263 ) 11.98
+Added: ( 213,192 ) 12.14
Outstanding at December 31, 2023
+Added: 9,639,068 $ 17.05
Total compensation expense associated with restricted stock grants was $ 34.1 million, $ 15.8 million and $ 58.4 million during the years ended December 31, 2023, 2022 and 2021 , respectively.
1 unchanged sentence
This amount does not include, as of December 31, 2023 , 2,470,770 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones.
−Removed: Milestone-based noncash compensation expense will be measured and recorded if and when a milestone occurs.
−Removed: The Company’s only outstanding warrants are the warrants issued to Hercules as part of our debt agreement to purchase 147,058 and 115,042 shares of common stock with exercise prices of $ 4.08 and $ 17.95 , respectively.
+Added: Milestone-based noncash compensation expense will be measured and recorded if and when a milestone becomes probable.
+Added: 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 (please refer to Note 7– Loan Payable) 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.
+Added: 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.
3 unchanged sentences
NOTE 7 – LOAN PAYABLE
−Removed: 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.
−Removed: (Hercules), the proceeds of which were used for research and development programs and for general corporate purposes.
+Added: On February 28, 2019 (the Closing Date), we entered into a term loan facility with Hercules Capital, Inc.
+Added: (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.
−Removed: An additional $ 30.0 million was available with different milestones and time points that have lapsed.
−Removed: On December 30, 2021 (the First Amendment Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules Capital, Inc.
−Removed: 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 First Amendment 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 Tranche 2 through Tranche 4 including increasing the amount available under Tranche 2 subject to the achievement of performance milestones from $ 10.0 million to $ 20.0 million, increasing the amount available under Tranche 3 subject to the achievement of performance milestones from $ 10.0 million to $ 45.0 million, and increasing the amount under Tranche 4 subject to the approval of Hercules’ investment committee from $ 10.0 million to $ 65.0 million, (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 %.
−Removed: The performance milestones are based on achievement of certain U.S.
−Removed: Food and Drug Administration 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.
−Removed: 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.
−Removed: The Amended Loan Agreement also contains warrant coverage of 2.95 % of the total amount funded.
−Removed: A warrant (the Warrant) was issued by the Company to Hercules to purchase 115,042 shares of common stock with an exercise price of $ 17.95 for the initial amount funded at closing.
+Added: 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.
+Added: 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.
+Added: 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 %.
+Added: In addition to the cash interest rate, the principal balance accrues 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.
+Added: 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.
+Added: The First Amendment amended the terms of the Amended Loan Agreement to, among other things:
+Added: (i) issue an advance of $ 25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) provide for the 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 (a Tranche 3B Advance and a 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 %.
+Added: 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, as amended.
+Added: The Amended Loan agreement, as amended, contains financial covenants that require the Company to maintain certain levels of unrestricted cash and additional financial covenants related to market capitalization.
+Added: As of December 31, 2023, we are in compliance with all financial covenants.
+Added: The First Amendment also contains warrant coverage of 2.95 % of each advance amount funded.
+Added: A warrant (the Warrant) was issued by the Company to Hercules to purchase 115,042 shares of common stock with an exercise price of $ 17.95 for the initial amount funded at the Closing Date.
The Warrant shall be exercisable for seven years from the date of issuance.
Hercules may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion.
−Removed: 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.
−Removed: The Company may, at its option, prepay the Amended Term Loan in full or in part, subject to a prepayment penalty equal to (i) 2.0 % of the principal amount prepaid if the prepayment occurs prior to the first anniversary of the First Amendment Closing Date, (ii) 1.5 % of the principal amount prepaid if the prepayment occurs on or after the first anniversary and prior to the second anniversary of the First Amendment Closing Date, and (iii) 1.0 % of the principal amount prepaid if the prepayment occurs on or after the second anniversary and prior to the third anniversary of the First Amendment Closing Date.
−Removed: The Company evaluated whether the Amended Term Loan entered into in December 2021 represented a debt modification or extinguishment of the Term Loan in accordance with ASC 470-50, Debt – Modifications and Extinguishments.
−Removed: As a result of the repayment and retirement of the Term Loan, the Term Loan was accounted for by the Company under the extinguishment accounting model.
−Removed: The Company recorded a loss on extinguishment of debt of approximately $ 0.2 million on the Company’s statement of operations for the twelve months ended December 31, 2021, representing the write-off of deferred financing costs.
+Added: Additionally, 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).
+Added: The First Amendment Warrant shall be exercisable for seven years from the date of issuance.
+Added: Hercules may exercise the First Amendment Warrant either by (a) cash or check or (b) through a net issuance conversion
+Added: 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 Amended Loan Agreement, as amended) plus 4.95 % of the aggregate principal amount of all other advances.
+Added: 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.
+Added: The Company evaluated whether the First Amendment represented a debt modification or extinguishment of the Amended Term Loan in accordance with ASC 470 - 50, Debt – Modifications and Extinguishments.
+Added: As a result of the modification of terms and no repayment or retirement of the Amended Term Loan, the Amended Term Loan was accounted for by the Company under the modification accounting model.
+Added: 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 year ended December 31, 2023.
TG Therapeutics, Inc.
2 unchanged sentences
The Company estimated the fair value of the Warrant using the Black-Scholes model based on the following key assumptions:
−Removed: Amended Term Loan
+Added: The First Amendment
+Added: The Amended Loan Agreement
+Added: The Loan Agreement
Exercise price
+Added: $ 14.70 $ 17.95 $ 4.08
Common share price on date of issuance
+Added: $ 15.04 $ 19.35 $ 6.80
+Added: 0.88 % 184.40 % 195.90 %
Risk-free interest rate
+Added: 3.6 % 1.4 % 2.6 %
Expected dividend yield
Contractual term (in years)
−Removed: The Company incurred financing expenses of $ 7.4 million (including the fair value of the Warrant) related to the Amended Loan Agreement which are recorded as debt issuance costs and as an offset to loan payable on the Company’s consolidated balance sheet.
−Removed: 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.
+Added: 7.00 7.00 7.00
+Added: 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 $ 2.4 million, $ 1.8 million and $ 1.1 million for the years ended December 31, 2023, 2022 and 2021 , respectively.
2 unchanged sentences
(in thousands)
+Added: $ 95,000 $ 70,000
Accreted Liability of final payment fee
+Added: 105,230 76,667
unamortized debt issuance costs
+Added: ( 5,112 ) ( 5,532 )
+Added: 100,118 71,135
principal payments
Total loan payable
+Added: 100,118 71,135
current portion
Loan payable non-current
+Added: $ 100,118 $ 71,135
NOTE 8 – LEASES
4 unchanged sentences
We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016.
−Removed: At January 1, 2019, we recognized a lease liability and corresponding 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.
+Added: 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 $ 10.7 million and $ 8.1 million, respectively, as of December 31, 2023 .
11 unchanged sentences
We took possession of this space in February 2022, with rental payments beginning in April 2022.
−Removed: The following components of lease expense are included in the Company’s consolidated statements of operations for the years ended December 31, 2022, 2021, and 2020:
−Removed: (in thousands)
−Removed: Operating lease cost
−Removed: Net lease cost
+Added: Operating lease cost was $ 2.2 million, $ 2.7 million and $ 2.2 million for the years ended December 31, 2023, 2022 and 2021, respectively.
As of December 31, 2023 , the weighted-average remaining operating lease term was 5.8 years and the weighted-average discount rate for operating leases was 10.00 %.
3 unchanged sentences
Lease liability current portion
+Added: $ 1,446 $ 1,581
Lease liability non-current
Total lease liability
+Added: $ 10,677 $ 11,925
As of December 31, 2023 , the maturities of lease liabilities were as follows:
−Removed: (in thousands)
Total lease payments
15 unchanged sentences
Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred.
−Removed: Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of 5 years for costs incurred in the US and 15 years for costs incurred in a non-US jurisdiction.
−Removed: The Company incurred approximately $ 135.4 million of US research and development costs and approximately $ 38.5 million of non-US research and development costs that were capitalized during the year ended December 31, 2022.
−Removed: The Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act) was enacted on March 27, 2020 in response to the economic fall out of the COVID-19 pandemic in the United States.
−Removed: The CARES Act allows employers to defer the deposit and payment of the employer’s share of Social Security taxes during the payroll tax deferral period of March 27, 2020 through December 31, 2020.
−Removed: The CARES Act provides for half of the deferred payroll taxes to be paid by December 31, 2021 and the second half to be paid by December 31, 2022.
−Removed: The Company did not participate in this deferral program.
+Added: Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of 5 years for costs incurred in the U.S.
+Added: and 15 years for costs incurred in a non-U.S.
+Added: jurisdiction.
+Added: The Company incurred approximately $ 61.8 million of U.S.
+Added: research and development costs and approximately $ 13.9 million of non-U.S.
+Added: research and development costs that were capitalized during the year ended December 31, 2023 .
The Inflation Reduction Act of 2022 (IRA) was enacted on August 16, 2022.
17 unchanged sentences
Net operating loss carryforwards
+Added: $ 316,962 $ 303,729
Research and development credit
+Added: 45,806 42,031
Noncash compensation
+Added: 12,275 10,325
Disallowed interest
Capitalized R&D Expenses
+Added: 36,613 39,411
Deferred tax asset, excluding valuation allowance
+Added: 418,317 400,363
Less valuation allowance
+Added: ( 418,317 ) ( 400,363 )
Net deferred tax assets
−Removed: There was no current or deferred income tax expense for the year ended December 31, 2022.
−Removed: Income tax expense differed from amounts computed by applying the US Federal income tax rate of 21 % for the years ending December 31, 2022, 2021 and 2020, to pretax loss as follows:
+Added: There was approximately $ 0.4 million of current income tax expense for the year ended December 31, 2023 .
+Added: Income tax expense differed from amounts computed by applying the US federal income tax rate of 21 % for the years ending December 31, 2023, 2022 and 2021 , to pretax income (loss) as follows:
For the year ended December 31,
1 unchanged sentence
Loss before income taxes, as reported in the consolidated statements of operations
+Added: $ 13,062 $ ( 198,335 ) $ ( 348,101 )
Computed “expected” tax benefit
+Added: $ 2,743 $ ( 41,650 ) $ ( 73,101 )
Increase (decrease) in income taxes resulting from:
Expected benefit from state and local taxes
+Added: 111 ( 7,242 ) ( 3,445 )
Research and development credits
+Added: ( 3,430 ) ( 6,389 ) ( 8,337 )
Officer Compensation Limitation
+Added: 1,167 4,391 439
+Added: ( 179 ) 374 428
Stock options
−Removed: Enactment of federal tax reform
+Added: ( 12,445 ) 17,599 ( 6,726 )
+Added: Change in state tax rates
+Added: ( 5,531 ) - -
Change in the balance of the valuation allowance for deferred tax assets
+Added: 17,954 32,917 90,742
+Added: $ 390 $ — $ —
We file income tax returns in the U.S federal and various state and local jurisdictions.
13 unchanged sentences
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.
−Removed: For the period ended December 31, 2022, we have incurred expenses of approximately $ 25.0 million related to the achievement of certain milestones of the LFB License Agreement, $ 12.0 million of which is recorded in accounts payable as of December 31, 2022.
+Added: For the period ended December 31, 2023 , we have incurred expenses of approximately $ 31.0 million related to the achievement of certain milestones of the LFB License Agreement.
These expenses are included in other research and development expenses in the accompanying consolidated statements of operations.
+Added: As of December 31, 2023 , we had approximately zero recorded in accounts payable related to the LFB License Agreement.
LFB Group is eligible to receive future payments of approximately $ 6.0 million, upon our successful achievement of certain regulatory milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate in the 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.
+Added: During the year ended December 31, 2023, the Company recorded $ 8.7 million related to the worldwide royalty due under the LFB License Agreement in cost of revenue based on U.S.
+Added: sales of BRIUMVI and as of December 31, 2023, approximately $ 3.9 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.
2 unchanged sentences
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.
−Removed: We recorded license revenue of approximately $ 0.2 million for each of the years ended December 31, 2022, 2021 and 2020, and at December 31, 2022 and 2021, have deferred revenue of approximately $ 0.5 million and $ 0.6 million, respectively, associated with this $ 2 million payment (approximately $ 0.2 million of which has been classified in current liabilities at December 31, 2022 and 2021).
+Added: We recorded license revenue of approximately $ 0.2 million for each of the years ended December 31, 2023, 2022 and 2021 , and at December 31, 2023 and 2022 , have deferred revenue of approximately $ 0.3 million and $ 0.5 million, respectively, associated with this $ 2 million payment.
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.
+Added: In July 2023, the Company entered into the Commercialization Agreement with Neuraxpharm.
+Added: The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories outside the United States, Canada, and Mexico, the commercialization rights for which had been previously retained by the Company, thus, and excluding certain Asian countries subject to previously existing partnerships.
+Added: Under the terms of the Commercialization Agreement, the Company received a one -time, non-refundable payment of $ 140.0 million upon contract execution (please refer to Note 2 – Revenue).
+Added: The Company is eligible to receive an additional $ 12.5 million upon first key market commercial launch in the EU and up to an additional $ 492.5 million in milestone-based payments on achievement of certain launch and commercial milestones.
+Added: In addition, TG will receive tiered double-digit royalties on net product sales up to 30 %.
+Added: In the event of a change of control of the Company (as defined in the Commercialization Agreement), the Company retains an option to buy back all rights under the Commercialization Agreement for a period of two years thereafter.
In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui, to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG- 1701 ( SHR1459 or EBI1459 ) or TG1702 ( SHR1266 or EBI1266 ).
14 unchanged sentences
On September 22, 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the TGR- 1202 License) with Rhizen Pharmaceuticals, SA (Rhizen) for the development and commercialization of umbralisib.
−Removed: As of December 31, 2022, we have incurred approximately $ 24.0 million in expense related to the achievement of certain milestones of the Umbralisib License.
+Added: As of December 31, 2023 , we have incurred approximately $ 24.0 million related to the achievement of certain milestones of the Umbralisib License.
Under the terms of the TGR 1202 License, Rhizen is eligible to receive approval and sales-based milestone payments in the aggregate of approximately $ 175 million payable.
1 unchanged sentence
Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib.
−Removed: 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.
−Removed: sales of UKONIQ and as of December 31, 2022, approximately $ 3,000 in royalties were payable under the Umbralisib License.
−Removed: As a result of the withdrawal of UKONIQ from the U.S.
+Added: UKONIQ was officialy withdrawn from the market in May 2022 and all commercialization activities were discontinued.
+Added: As a result of the withdrawal, during the year ended December 31, 2023, the Company recorded zero related to the worldwide royalty due under the Umbralisib License in cost of revenue based on U.S.
+Added: sales of UKONIQ, and as of December 31, 2023, no royalties were payable under the Umbralisib License.
+Added: Due to 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.
1 unchanged sentence
The Collaboration Agreement was amended in June 2019 and in March of 2020.
−Removed: We incurred expenses of approximately $ 0.1 million, $ 0.1 million and $ 1.1 million for the years ended December 31, 2022, 2021 and 2020, respectively, the majority of which relates to manufacturing expenses and milestone payments of PD-L1.
+Added: We incurred expenses of approximately $ 0.1 million for each of the years ended December 31, 2023, 2022 and 2021 , the majority of which relates to manufacturing expenses, clinical study expenses and milestone payments of PD- L1.
The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations.
17 unchanged sentences
Operating leases
+Added: $ 15,023 $ 2,388 $ 4,180 $ 3,740 $ 4,715
Long-term debt
+Added: 100,403 — 100,403 — —
+Added: $ 115,426 $ 2,388 $ 104,583 $ 3,740 $ 4,715
See Note 8 - leases for a detailed description of our lease arrangements in New York, New Jersey and North Carolina.
Total rental expense was approximately $ 2.2 million, $ 2.7 million and $ 2.2 million for the years ended December 31, 2023, 2022 and 2021 , respectively.
−Removed: Future minimum lease commitments as of December 31, 2022, in the aggregate total approximately $ 17.4 million through December 31, 2032.
+Added: Future minimum lease commitments as of December 31, 2023 , in the aggregate total approximately $ 15.0 million through July 31, 2031.
The preceding table shows future minimum lease commitments, which include our office leases in New York, New Jersey, and North Carolina by year as of December 31, 2023 .
See Note 7 – Loan payable for a detail description of our loan agreement.
+Added: NOTE 13 – Subsequent Events
+Added: Precision Bio
+Added: On January 7, 2024, TG and its wholly-owned subsidiary, TG Cell Therapy, Inc., entered into a License Agreement (the Precision License Agreement ) with Precision BioSciences, Inc.
+Added: ( Precision ), pursuant to which Precision granted the Company certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize Precision’s allogeneic CAR T therapy azercabtagene zapreleucel ( azer-cel ) for the treatment of autoimmune and other non-oncology diseases and conditions (collectively, the Field ).
+Added: Pursuant to the Precision License Agreement, the Company will make an upfront payment to Precision of $ 7.5 million, consisting of (i) $ 5.25 million in cash and (ii) $ 2.25 million, as an equity investment, for the purchase of 2,920,816 shares of Precision’s common stock at a price of $ 0.77 per share.
+Added: Within 12 months of the Precision License Agreement, the Company will make a deferred payment of $ 2.5 million to Precision, consisting of an equity investment in Precision’s common stock at a 100% premium to the 30 -day volume-weighted average price (the 30 -day VWAP ) prior to purchase.
+Added: Upon achievement of certain near-term clinical or time-based milestones, the Company will make a $ 7.5 million payment to Precision, a portion of which will also be an equity investment in Precision’s common stock at a 100% premium to the 30 -day VWAP prior to purchase.
+Added: Precision will be eligible to receive up to $ 288 million in additional milestone payments based on the achievement of certain clinical, regulatory, and commercial milestones.
+Added: In addition, the Company is obligated to pay Precision high-single-digit to low-double-digit royalties on net sales of the licensed product on a country-by-country basis until the latest to occur of patent expiration, loss of regulatory exclusivity, and a period of ten years following the first commercial sale of the licensed product in such country.
+Added: The Company has also agreed to make certain payments to Precision’s licensors during the term of the Precision License Agreement.
+Added: BRIUMVI Launch
+Added: On February 26, 2024, TG announced that its ex-US partner, Neuraxpharm launched BRIUMVI in Europe, for the treatment of adults patients with relapsing forms of multiple sclerosis (RMS), who have active disease defined by clinical or imaging features.
+Added: The launch commenced in Germany, with additional launches throughout Europe to follow.
+Added: In accordance with the ex-US commercialization agreement, TG will receive a milestone payment of $ 12.5 million for the first launch of BRIUMVI in a European country.
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
TG THERAPEUTICS, INC.
−Removed: March 1, 2023
+Added: February 29, 2024
/s/ Michael S.
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POWER OF ATTORNEY
−Removed: KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S.
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Michael S.
Weiss and Sean A.
Power, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and his name, place and stead, in any and all capacities, to sign any or all amendments to this annual report on Form 10-K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or any of his substitutes, may lawfully do or cause to be done by virtue hereof.
−Removed: Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on March 1, 2023, and in the capacities indicated:
+Added: Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Form 10-K has been signed by the following persons on behalf of the Registrant on February 29, 2024, and in the capacities indicated:
/s/ Michael S.
9 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.