Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures. 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. Based upon that evaluation, our Chief Executive and Chief Financial Officers concluded that, as of December 31, 2023, our disclosure controls and procedures were effective.
Management ’ s Annual Report on Internal Control over Financial Reporting. Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) or Rule 15d-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, our management used the criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO Framework. Our management has concluded that, as of December 31, 2023, our internal control over financial reporting was effective based on these criteria.
The effectiveness of our internal control over financial reporting as of December 31, 2023 was audited by KPMG LLP, our independent registered public accounting firm, as stated in their report.
Changes in Internal Control Over Financial Reporting. There were no changes in our internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls. Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.
ITEM 9B. OTHER INFORMATION.
Securities Trading Plans of Directors and Executive Officers
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).
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2024 Annual Meeting of Stockholders.
ITEM 11. EXECUTIVE COMPENSATION.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2024 Annual Meeting of Stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2024 Annual Meeting of Stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2024 Annual Meeting of Stockholders.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2024 Annual Meeting of Stockholders.
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PART IV
ITEM 15. EXHIBITS and FINANCIAL STATEMENT SCHEDULES.
1. Consolidated Financial Statements
The following consolidated financial statements of TG Therapeutics, Inc. are filed as part of this report.
Contents
Page
Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185)
F-1
Consolidated Balance Sheets as of December 31, 2023 and 2022
F-5
Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021
F-6
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021
F-7
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021
F-8
Notes to Consolidated Financial Statements
F-9
2. Consolidated Financial Statement Schedules
All schedules are omitted as the information required is inapplicable or the information is presented in the consolidated financial statements or the related notes.
3. Exhibits
Exhibit
Number
Exhibit Description
3.1
Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated April 26, 2012 (incorporated by reference to Exhibit 3.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2012).
3.2
Certificate of Amendment to Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated June 9, 2014 (incorporated by reference to Exhibit 3.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).
3.3
Certificate of Amendment to Amended and Restated Certificate of Incorporation of TG Therapeutics, Inc. dated June 16, 2021 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 21, 2021).
3.4
Amended and Restated Bylaws of TG Therapeutics, Inc. dated July 18, 2014 (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2014).
4.1
Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K for the year ended December 31, 2011).
4.2
Stockholder Protection Rights Agreement, dated July 18, 2014 between TG Therapeutics, Inc. and American Stock Transfer & Trust Company, LLC, as Rights Agent (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2014).
4.3
Description of Securities of TG Therapeutics, Inc. (incorporated by reference to Exhibit 4.5 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020).
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10.1
Employment Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.30 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †
10.2
Restricted Stock Subscription Agreement, effective December 29, 2011, between the Registrant and Michael Weiss (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †
10.3
Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Michael S. Weiss (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). †
10.4
Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Michael S. Weiss (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). †
10.5
Employment Agreement, effective December 29, 2011, between the Registrant and Sean Power (incorporated by reference to Exhibit 10.32 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †
10.6
Restricted Stock Subscription Agreement, effective December 29, 2011 between the Registrant and Sean Power (incorporated by reference to Exhibit 10.33 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). †
10.7
Amendment to Restricted Stock Agreement, dated July 12, 2013, by and between TG Therapeutics, Inc. and Sean A. Power (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on July 16, 2013). †
10.8
Amendment to Restricted Stock Agreements, dated December 31, 2014, by and between TG Therapeutics, Inc. and Sean A. Power (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on January 7, 2015). †
10.9
License Agreement dated January 30, 2012, by and among the Registrant, GTC Biotherapeutics, Inc., LFB Biotechnologies S.A.S. and LFB/GTC LLC (incorporated by reference to Exhibit 10.35 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2011). *
10.10
Sublicense Agreement between TG Therapeutics, Inc. and Ildong Pharmaceutical Co. Ltd., dated November 13, 2012 (incorporated by reference to Exhibit 10.37 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2012). *
10.11
License Agreement between TG Therapeutics, Inc. and Ligand Pharmaceuticals Incorporated, dated June 23, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2014).*
10.12
License Agreement between TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA, dated September 22, 2014 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on January 20, 2015). *
10.13
Collaboration Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated March 3, 2015 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2015). *
10.14
Sublicense Agreement between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated May 27, 2016, (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2016). *
10.15
Amendment to Employment Agreement, effective January 1, 2017, between TG Therapeutics, Inc. and Michael S. Weiss (incorporated by reference to Exhibit 10.18 to the Registrant’s Form 10-K/A for the year ended December 31, 2016). †
10.16
License Agreement between TG Therapeutics, Inc. and Jiangsu Hengrui Medicine Co., dated January 8, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-K for the year ended December 31, 2017). *
10.17
Joint Venture and License Option Agreement by and between TG Therapeutics, Inc. and Novimmune S.A., dated June 18, 2018 (incorporated by reference to Exhibit 10.20 to the Registrant’s Form 10-Q for the quarter ended June 30, 2018). *
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10.18
Master Services Agreement between Samsung Biologics Co., Ltd. And TG Therapeutics, Inc., effective February 21, 2018 (incorporated by reference to the Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). *
10.19
Loan and Security Agreement, dated February 28, 2019, by and among TG Therapeutics, Inc., TG Biologics, Inc. and Hercules Capital, Inc. (incorporated by reference to the Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019).
10.20
Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Capital, Inc. (incorporated by reference to the Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019).
10.21
Warrant Agreement, dated February 28, 2019, by and between TG Therapeutics, Inc. and Hercules Technology III, L.P. (incorporated by reference to the Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed on March 5, 2019).
10.22
Amended and Restated Collaboration Agreement by and between TG Therapeutics, Inc. and Checkpoint Therapeutics, Inc., dated June 19, 2019 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended June 30, 2019). *
10.23
Amended and Restated Employment Agreement by and between TG Therapeutics, Inc. and Michael S. Weiss, dated June 18, 2021 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10 Q for the quarter ended June 30, 2021). †
10.24
Amended and Restated Loan and Security Agreement, dated December 30, 2021, by and among TG Therapeutics, Inc., TG Biologics, Inc. and Hercules Capital, Inc. (incorporated by reference to Exhibit 10.28 to the Registrant’s Form 10-K for the year ended December 31, 2021).
10.25
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc. and Hercules Capital Inc. (incorporated by reference to Exhibit 10.29 to the Registrant’s Form 10-K for the year ended December 31, 2021).
10.26
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund I L.P. (incorporated by reference to Exhibit 10.30 to the Registrant’s Form 10-K for the year ended December 31, 2021).
10.27
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc. and Hercules Private Global Venture Growth Fund I L.P. (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the year ended December 31, 2021).
10.28
TG Therapeutics, Inc. 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). †
10.29
First Amendment to Amended and Restated Loan and Security Agreement, dated March 31, 2023, by and among TG Therapeutics, Inc., TG Biologics, Inc. and Hercules Capital, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.30
Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Capital Inc. (incorporated by reference to Exhibit 10.2 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.31
Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Funding IV, LLC. (incorporated by reference to Exhibit 10.3 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.32
Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P. (incorporated by reference to Exhibit 10.4 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.33
Amended and Restated Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Global Venture Growth Fund I L.P. (incorporated by reference to Exhibit 10.5 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.34
Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Capital Inc. (incorporated by reference to Exhibit 10.6 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023).
10.35
Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Credit Fund 1 L.P. (incorporated by reference to Exhibit 10.7 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.36
Warrant Agreement, dated March 31, 2023, by and between TG Therapeutics, Inc. and Hercules Private Global Venture Growth Fund I L.P. (incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-Q for the quarter ended March 31, 2023). *
10.37
Commercialization Agreement by and between TG Therapeutics, Inc. 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). *
10.38
License Agreement, dated January 7, 2024, by and between TG Therapeutics, Inc., TG Cell Therapy, Inc., and Precision BioSciences, Inc. # *
19.1
TG Therapeutics, Inc. Insider Trading Policy #
21.1
Subsidiaries of TG Therapeutics, Inc. #
23.1
Consent of Independent Registered Public Accounting Firm (KPMG, LLP). #
24.1
Power of Attorney (included in signature page).
31.1
Certification of Principal Executive Officer. #
31.2
Certification of Principal Financial Officer. #
32.1
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. #
32.2
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. #
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97.1
TG Therapeutics, Inc. Clawback Policy #
101
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): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows, (v) the Notes to Consolidated Financial Statements.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).
#
Filed Herewith.
†
Indicates management contract or compensatory plan or arrangement.
*
Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K.
TG Therapeutics, Inc.
Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm (KPMG LLP, New York, NY, Audit Firm ID: 185)
F-1
Consolidated Balance Sheets as of December 31, 2023 and 2022
F-4
Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021
F-5
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021
F-7
Notes to Consolidated Financial Statements
F-8
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Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
TG Therapeutics, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc. 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). 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.
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
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. 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. Our audits 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. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits 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. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. 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.
F-1
Table of Contents
Commercialization agreement with Neuraxpharm
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. (Neuraxpharm) that granted Neuraxpharm the exclusive right to commercialize BRIUMVI in certain territories. The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI. 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. In 2023, the Company recognized a non-refundable upfront payment of $140.0 million as License Revenue related to the Commercialization Agreement.
We identified the evaluation of the accounting for the supply terms of the Commercialization Agreement with Neuraxpharm as a critical audit matter. 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. 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. We obtained an understanding of the Commercialization Agreement by reading the contracts and conducting meetings with Company personnel responsible for negotiating the contracts. We evaluated management’s accounting conclusions with respect to the supply terms within the Commercialization Agreement. 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. 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. 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.
/s/ KPMG LLP
We have served as the Company’s auditor since 2021.
New York, New York
February 29, 2024
F-2
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors
TG Therapeutics, Inc.:
Opinion on Internal Control Over Financial Reporting
We have audited TG Therapeutics, Inc. and subsidiaries' (the Company) 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. 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.
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
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ KPMG LLP
New York, New York
February 29, 2024
F-3
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets as of December 31
(in thousands, except share and per share amounts)
December 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$ 92,933 $ 102,304
Short-term investment securities
124,575 59,374
Accounts receivable, net
51,093 —
Inventories
39,823 —
Prepaid research and development
4,183 4,237
Other current assets
5,336 2,359
Total current assets
317,943 168,274
Restricted cash
1,285 1,273
Long-term investment securities
— 12,404
Right of use assets
8,050 8,888
Leasehold interest, net
1,415 1,627
Equipment, net
95 307
Goodwill
799 799
Total assets
$ 329,587 $ 193,572
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 38,471 $ 42,019
Other current liabilities
1,631 1,169
Lease liability – current portion
1,446 1,581
Accrued compensation
12,172 8,432
Total current liabilities
53,720 53,201
Deferred revenue
6,016 305
Loan payable
100,118 71,135
Lease liability – non-current
9,231 10,344
Total liabilities
169,085 134,985
Commitments and contingencies
Stockholders’ equity:
Common stock, $ 0.001 par value per share ( 175,000,000 shares authorized, 151,465,598 and 146,426,697 shares issued, 151,424,289 and 146,385,388 shares outstanding at December 31, 2023 and December 31, 2022, respectively
151 146
Additional paid-in capital
1,674,946 1,585,708
Treasury stock, at cost, 41,309 shares at December 31, 2023 and December 31, 2022
( 234 ) ( 234 )
Accumulated deficit
( 1,514,361 ) ( 1,527,033 )
Total stockholders’ equity
160,502 58,587
Total liabilities and stockholders’ equity
$ 329,587 $ 193,572
The accompanying notes are an integral part of the consolidated financial statements.
F-4
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations for the Years Ended December 31
(in thousands, except share and per share amounts)
2023
2022
2021
Revenue:
Product revenue, net
92,005
2,633
6,537
License, milestone and other revenue
$ 141,657
$ 152
$ 152
Total revenue
233,662
2,785
6,689
Costs and expenses:
Cost of revenue
14,131
265
790
Research and development:
Noncash compensation
13,010
13,224
24,047
Other research and development
63,182
112,128
198,532
Total research and development
76,192
125,352
222,579
Selling, general and administrative:
Noncash compensation
24,923
5,961
37,227
Other selling, general and administrative
97,783
64,046
90,863
Total selling, general and administrative
122,706
70,007
128,090
Total costs and expenses
213,029
195,624
351,459
Operating income (loss)
20,633
(192,839)
(344,770)
Other expense (income):
Interest expense
12,615
10,191
5,638
Other income
(5,044)
(4,695)
(2,307)
Total other expense (income), net
7,571
5,496
3,331
Net income (loss) before taxes
$ 13,062
$ (198,335)
$ (348,101)
Income taxes
390
—
—
Net income (loss)
$ 12,672
$ (198,335)
$ (348,101)
Net income (loss) per common share:
Basic
$ 0.09
$ (1.46)
$ (2.63)
Diluted
$ 0.09
$ (1.46)
$ (2.63)
Weighted-average shares outstanding:
Basic
141,955,112
135,411,258
132,222,753
Diluted
148,508,465
135,411,258
132,222,753
The accompanying notes are an integral part of the consolidated financial statements.
F-5
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Stockholders ’ Equity for the Years Ended December 31
(in thousands, except share amounts)
Additional
Common Stock
paid-in
Treasury Stock
Accumulated
Shares
Amount
capital
Shares
Amount
Deficit
Total
Balance at January 1, 2021
140,617,606 141 1,500,040 41,309 ( 234 ) ( 980,597 ) 519,350
Issuance of common stock in connection with exercise of options
52,694 * 216 — — — 216
Issuance of restricted stock
2,738,974 2 ( 2 ) — — — —
Warrants issued with debt financing
— — 2,195 — — — 2,195
Forfeiture of restricted stock
( 189,231 ) * — — — — —
Offering Costs Paid
— — ( 204 ) — — — ( 204 )
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.1 million)
72,000 * 2,423 — — — 2,423
Compensation in respect of restricted stock granted to employees, directors and consultants
— — 61,274 — — — 61,274
Net income (loss)
— — — — — ( 348,101 ) ( 348,101 )
Balance at December 31, 2021
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
142,409 * 584 — — — 584
Issuance of restricted stock
5,179,201 5 ( 5 ) — — — —
Forfeiture of restricted stock
( 2,186,956 ) ( 2 ) 2 — — — —
Compensation in respect of restricted stock granted to employees, directors and consultants
— — 19,185 — — — 19,185
Net income (loss)
— — — — — ( 198,335 ) ( 198,335 )
Balance at December 31, 2022
146,426,697 146 1,585,708 41,309 ( 234 ) ( 1,527,033 ) 58,587
Issuance of common stock in connection with exercise of options
246,156 — 1,534 — — — 1,534
Issuance of restricted stock
3,620,237 4 ( 4 ) — — — —
Warrants issued with debt financing
— — 595 — — — 595
Forfeiture of restricted stock
( 213,192 ) — — — — — —
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.8 million)
1,385,700 1 46,295 — — — 46,296
Compensation in respect of restricted stock granted to employees, directors and consultants
— — 40,818 — — — 40,818
Net income (loss)
— — — — — 12,672 12,672
Balance at December 31, 2023
151,465,598 $ 151 $ 1,674,946 41,309 $ ( 234 ) $ ( 1,514,361 ) 160,502
* Amount less than one thousand dollars.
The accompanying notes are an integral part of the consolidated financial statements.
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TG Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Cash Flows for the Years Ended December 31
(in thousands)
2023
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net income (loss)
$ 12,672 $ ( 198,335 ) $ ( 348,101 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Noncash stock compensation expense
37,933 19,185 61,274
Depreciation and amortization
211 303 282
Amortization of premium (discount) on investment securities
( 2,236 ) ( 331 ) 517
Amortization of debt issuance costs
2,378 1,844 1,080
Amortization of leasehold interest
212 212 212
Noncash change in lease liability and right of use asset
1,963 2,715 1,896
Change in fair value of notes payable
113 ( 116 ) ( 578 )
Changes in assets and liabilities:
Increase in inventory
( 36,938 ) — —
Decrease (increase) in other current assets
( 2,831 ) 8,181 ( 8,508 )
Decrease (increase) in accounts receivable
( 51,093 ) 1,389 ( 1,389 )
(Decrease) increase in accounts payable and accrued expenses
192 ( 11,010 ) 15,991
Decrease in lease liabilities
( 2,375 ) ( 2,332 ) ( 2,012 )
Increase (decrease) in other current liabilities
2,675 2,277 ( 16,146 )
Increase (decrease) in deferred revenue
5,711 ( 152 ) ( 152 )
Net cash used in operating activities
( 31,413 ) ( 176,170 ) ( 295,634 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from maturity of short-term securities
96,229 87,275 55,600
Investment in held-to-maturity securities
( 146,880 ) ( 107,274 ) ( 55,531 )
Purchases of PPE
— ( 14 ) ( 401 )
Net cash used in investing activities
( 50,651 ) ( 20,013 ) ( 332 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of loan payable
— ( 975 ) ( 30,000 )
Proceeds from sale of common stock, net
46,296 — 2,219
Proceeds from exercise of options
1,534 584 216
Proceeds from debt financings
25,000 — 70,000
Financing costs paid
( 125 ) — ( 1,016 )
Net cash provided by (used in) financing activities
72,705 ( 391 ) 41,419
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
( 9,359 ) ( 196,574 ) ( 254,547 )
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD
103,577 300,151 554,698
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$ 94,218 $ 103,577 $ 300,151
Reconciliation to amounts on condensed consolidated balance sheets:
Cash and cash equivalents
$ 92,933 $ 102,304 $ 298,887
Restricted cash
1,285 1,273 1,264
Total cash, cash equivalents and restricted cash
$ 94,218 $ 103,577 $ 300,151
Cash paid for:
Interest
8,771 $ 5,445 $ 3,466
NONCASH TRANSACTIONS
Deferred Financing Costs
$ 1,238 — —
Warrants issued with debt financing
$ 595 — —
The accompanying notes are an integral part of the consolidated financial statements.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Unless the context requires otherwise, references in this report to “ TG, ” “ Company, ” “ we, ” “ us ” and “ our ” refer to TG Therapeutics, Inc. and our subsidiaries.
NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
DESCRIPTION OF BUSINESS
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S. 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
Historically, we have incurred operating losses since our inception; 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. commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm) (see Note 2 for more information). 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.
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. (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. 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. We also began shipping BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, in November 2023. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership; successfully complete any post-approval regulatory obligations; and our ability to maintain or obtain regulatory approval for our drug candidates. 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. 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. 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. 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. 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
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.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
USE OF ESTIMATES
The preparation of financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue, accrued clinical trial expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements.
CASH AND CASH EQUIVALENTS
We treat liquid investments with original maturities of less than three months when purchased as cash and cash equivalents.
RESTRICTED CASH
We record cash pledged or held in trust as restricted cash. As of December 31, 2023 and 2022 , we have approximately $ 1.3 million of restricted cash pledged to secure a line of credit as a security deposit for an Office Agreement (see Note 7 ).
INVESTMENT SECURITIES
Investment securities at December 31, 2023 and 2022 consist of short-term and long-term government securities. We classify these securities as held-to-maturity. Held-to-maturity securities are those securities in which we have the ability and intent to hold the security until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortized or accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method.
A decline in the market value of any investment security below cost that is deemed to be other than temporary, results in a reduction in the carrying amount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment charges are included in interest and other income (expense), net. Dividend and interest income are recognized when earned.
CREDIT RISK
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents and short-term investments with high-credit quality financial institutions. At times, such amounts may exceed federally-insured limits.
REVENUE RECOGNITION
Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five -step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation.
At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Product Revenue, Net – The Company recognizes product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, 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). The Company's estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company's current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration received may ultimately differ from the Company's estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.
Chargebacks: Chargebacks for discounts represent the Company’s estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers and government agencies at prices lower than the list prices charged to the customers who directly purchase the product from the Company. The customers charge the Company for the difference between what the customers pay the Company for the product and the customers’ ultimate contractually committed or government required lower selling price to the qualified healthcare providers.
Government Rebates: Government rebates consist of Medicare, Tricare, and Medicaid rebates. These reserves are recorded in the same period the related revenue is recognized. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe a rebate under the Medicare Part D program.
Trade Discounts and Allowances: The Company provides its customers with discounts that are explicitly stated in the contracts and are recorded in the period the related product revenue is recognized. In addition, the Company also receives sales order management, inventory management, and data services from its customers in exchange for certain fees.
Commercial Payer Rebates: 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. 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: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel.
Subject to certain limitations, the Company’s return policy allows for eligible returns of commercial products sold for credit under the following circumstances:
●
receipt of damaged product;
●
shipment errors that were a result of an error by the Company;
●
expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date;
●
product subject to a recall; and
●
product that the Company, at its sole discretion, has specified can be returned for credit.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
As of December 31, 2023 , the Company has not received any returns related to sales of BRIUMVI.
Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider. Reserves for co-payment assistance are recorded in the same period the related revenue is recognized.
License Agreements –
The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. 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. Licenses of intellectual property: 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. All other promised goods or services in the agreement are evaluated to determine if they are distinct. 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.
Milestone payments: 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. 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. 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. 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. 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.
Sales-based royalties: 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).
Optional Purchases: The Company’s arrangements may provide the licensee the right to make optional purchases of the licensed product. 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.
Other Revenue
Revenue is also generated from service-based fees recognized for providing regulatory support and development services to customers. Service fee revenue is recognized overtime as the services are transferred to the customer.
DEFERRED PRODUCT REVENUE
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. Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities. 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
In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. Our contracts with customers have standard payment terms. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of 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.
COST OF REVENUE
Cost of revenue consists primarily of third -party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales. 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. 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. Our cost of revenue also relates to providing regulatory support & development services to customers.
INVENTORY
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. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials.
Prior to the approval of BRIUMVI, all manufacturing and other potential costs related to the commercial launch of BRIUMVI were expensed to research and development expense in the period incurred.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
RESEARCH AND DEVELOPMENT COSTS
Generally, research and development costs are expensed as incurred. Research and development expenses consist primarily of costs incurred to third -party service providers for the conduct of research, preclinical and clinical studies, contract manufacturing costs, license milestone fees, personnel costs for our research and development employees, consulting, and other related expenses. We recognize research, preclinical and clinical study expenses based on services performed, pursuant to contracts with third -party research and development organizations that conduct and manage research, preclinical and clinical activities on our behalf. We accrue these expenses based on the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original accrual, we will adjust the accrual accordingly. With respect to clinical trial costs, the financial terms of these agreements are subject to an initial negotiation and vary from contract to contract. Payments under these contracts may be uneven and depend on factors such as the achievement of certain events, the successful recruitment of patients, the completion of portions of the clinical trial or similar conditions. As such, certain expense accruals related to clinical site costs are recognized based on the degree of performance of the event or events specified in the specific clinical study or trial contract.
Prepaid research and development in our consolidated balance sheets includes, among other things, costs related to agreements with CROs, certain costs to third -party service providers related to development and manufacturing services as well as clinical development. These agreements often require payments in advance of services performed or goods received. Accordingly, as of December 31, 2023 and December 31, 2022 , we recorded approximately $ 4.2 million in prepaid research and development related to such advance agreements.
INCOME TAXES
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. If the likelihood of realizing the deferred tax assets or liability is less than “more likely than not,” a valuation allowance is then created.
We, and our subsidiaries, file income tax returns in the U.S. federal jurisdiction and in various states. We have tax net operating loss carryforwards that are subject to examination for a number of years beyond the year in which they were generated for tax purposes. Since a portion of these net operating loss carryforwards may be utilized in the future, many of these net operating loss carryforwards will remain subject to examination. We recognize interest and penalties related to uncertain income tax positions in income tax expense. Refer to Note 9 for further information on impact of tax reform.
STOCK-BASED COMPENSATION
The Company measures employee and non-employee stock-based compensation based on the grant date fair value of the stock-based compensation award. The Company grants stock options at exercise prices equal to the fair value of the Company’s common stock on the date of grant, based on observable market prices. The Company uses the Black-Scholes option-pricing model to measure the fair value of stock option awards. We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements. Stock-based compensation expense recognized each period is based on the value of the portion of stock-based payment awards that is ultimately expected to vest during the period. Forfeitures are recognized as they occur.
In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NET INCOME (LOSS) PER COMMON SHARE
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. 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. The impact of these items is anti-dilutive during periods of net loss. 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 :
December 31,
2023
2022
2021
Unvested restricted stock
8,139,037 7,232,254 10,532,029
Options
4,697,029 5,135,685 2,467,537
Warrants
312,272 262,100 262,100
Shares issuable upon note conversion
20,902 20,619 18,942
Total
13,169,240 12,650,658 13,280,608
The computation of basic and diluted earnings per share (EPS) is as follows:
Year ended
December 31,
(in thousands, except share and per share data)
2023
2022
2021
Net income (loss)
12,672 ( 198,335 ) ( 348,101 )
Weighted-average common shares outstanding
141,955,112 135,411,258 132,222,753
Dilutive effect of potential common shares
6,553,353 - -
Weighted-average common shares outstanding assuming dilution
148,508,465 135,411,258 132,222,753
Net income (loss) per share - basic
0.09 ( 1.46 ) ( 2.63 )
Net income (loss) per share - diluted
0.09 ( 1.46 ) ( 2.63 )
LONG-LIVED ASSETS AND GOODWILL
Long-lived assets are reviewed for potential impairment when circumstances indicate that the carrying value of long-lived tangible and intangible assets with finite lives may not be recoverable. Management’s policy in determining whether an impairment indicator exists, a triggering event, comprises measurable operating performance criteria as well as qualitative measures. If an analysis is necessitated by the occurrence of a triggering event, we make certain assumptions in determining the impairment amount. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized.
Goodwill results from excess consideration in a business combination over the fair value of identifiable net assets acquired. 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. 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.
LEASES
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. 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. 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. 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. 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. 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. 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.
NOTE 2 - REVENUE
As discussed in Note 1, revenues are recognized under guidance within ASC 606. The following table presents our disaggregated revenue for the periods presented (in thousands):
(in thousands)
Year ended December 31,
2023
2022
2021
Total product revenue, net
$ 92,005 2,633 6,537
License Revenue
140,153 152 152
Other Revenue
1,504 - -
Total Revenue
$ 233,662 $ 2,785 $ 6,689
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Product revenue, net
The following table presents our disaggregated revenue by product and geography for the periods presented:
(in thousands)
Year ended December 31,
2023
2022
2021
BRIUMVI
U.S.
$
88,786
$
-
$
-
International
3,219
-
-
Worldwide
$
92,005
$
-
$
-
UKONIQ
U.S.
$
-
$
2,633
$
6,537
International
-
-
-
Worldwide
$
-
$
2,633
$
6,537
Total product revenue, net
U.S.
$
88,786
$
2,633
$
6,537
International
3,219
-
-
Worldwide
$
92,005
$
2,633
$
6,537
We began shipping BRIUMVI to our U.S. customers in January 2023. We also began shipping BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, in November 2023. UKONIQ was voluntarily withdrawn from the U.S. market effective May 31, 2022.
During 2023, approximately $ 9.2 million of gross-to-net accruals entirely related to U.S. 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.
License Agreements
Neuraxpharm Commercialization Agreement
On July 28, 2023, the Company entered into the Commercialization Agreement with Neuraxpharm. 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). 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. As part of the overall arrangement, the Company has agreed to supply BRIUMVI to Neuraxpharm throughout the term of the Commercialization Agreement.
In consideration for entering the Commercialization Agreement, the Company received a non-refundable upfront payment of $ 140.0 million. 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.
The Company evaluated the Commercialization Agreement under ASC 606 and concluded that Neuraxpharm represents a customer in the transaction. In accordance with this guidance, the Company identified the following commitments under the arrangement: (i) grant the exclusive right to develop, sell, offer to sell and import BRIUMVI in the Territory (the “License”); and (ii) perform certain development and regulatory activities (“Development and Regulatory Activities”).
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.
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. Therefore, revenue is recognized as the activities are completed by the Company. During 2023 the Company recognized Other Revenue of $ 1.5 million related to the Development and Regulatory Activities.
The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI (the “Supply of Licensed Product”). These optional purchases are accounted for as a separate contract when the right to purchase BRIUMVI is exercised. 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.
The performance obligation related to the Supply of Licensed Product is satisfied when control of the product passes to Neuraxpharm. The consideration received from Neuraxpharm for the supply of BRIUMVI is recognized by the Company as a component of product revenue, net. 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. 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. 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. The Company will reevaluate the consideration received, and performance obligations satisfied at the end of each reporting period. Such reevaluations may result in a change to the amount of product revenue, net, recognized and deferred revenue.
The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. 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. 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. Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met. All other milestones will be recognized as revenue immediately in the period the achievement of the underlying milestone is probable. Any consideration related to sales-based royalties will be recognized when the related sales occur. No royalty or milestone revenue was recognized during 2023.
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Notes to Consolidated Financial Statements
NOTE 3 – INVESTMENT SECURITIES
Our investments as of December 31, 2023 and 2022 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost.
The following tables summarize our investment securities at December 31, 2023 and 2022 :
December 31, 2023
Amortized
Gross
Gross
cost, as
unrealized
unrealized
Estimated
(in thousands)
adjusted
holding gains
holding losses
fair value
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2024 and June 2024 ) (held-to-maturity)
$ 124,575 $ 30 $ 53 $ 124,552
Total short-term investment securities
$ 124,575 $ 30 $ 53 $ 124,552
December 31, 2022
Amortized
Gross
Gross
cost, as
unrealized
unrealized
Estimated
adjusted
holding gains
holding losses
fair value
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2023 and December 2023 ) (held-to-maturity)
$ 59,374 $ — $ 1,053 $ 58,321
Long-term investments:
Obligations of domestic governmental agencies (maturing between January 2024 and February 2024 ) (held-to-maturity)
12,404 — 429 11,975
Total short-term and long-term investment securities
$ 71,778 $ — $ 1,482 $ 70,296
NOTE 4 – INVENTORY
The following table presents our inventory as of December 31, 2023 ( in thousands):
December 31, 2023
Raw Materials
$ 6,582
Work in Process
31,243
Finished Goods
1,999
Total Inventory
$ 39,824
Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-process and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. At 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. 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. 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. Inventory that is used for clinical development purposes is expensed to research and development expense when consumed. For December 30, 2023 we determined that a reserve related to BRIUMVI inventory is not required.
NOTE 5 – FAIR VALUE MEASUREMENTS
We measure certain financial assets and liabilities at fair value on a recurring basis in the financial statements. The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
●
Level 1 – quoted prices in active markets for identical assets and liabilities;
●
Level 2 – inputs other than Level 1 quoted prices that are directly or indirectly observable; and
●
Level 3 – unobservable inputs that are not corroborated by market data.
At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc. (Manhattan)) with Ariston Pharmaceuticals, Inc. (Ariston) in March 2010, Ariston issued $ 15.5 million of five -year 5 % notes payable (the 5% Notes) in satisfaction of several note payable issuances. The 5% Notes and accrued and unpaid interest thereon are convertible at the option of the holder into common stock at the conversion price of $ 1,125 per share. We have no obligations under the 5% Notes aside from the conversion feature.
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Notes to Consolidated Financial Statements
The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2023 and 2022 :
Financial liabilities at fair value as of December 31, 2023
(in thousands)
Level 1
Level 2
Level 3
Total
5% Notes
$ — $ — $ 357 $ 357
Total
$ — $ — $ 357 $ 357
Financial liabilities at fair value as of December 31, 2022
Level 1
Level 2
Level 3
Total
5% Notes
$ — $ — $ 243 $ 243
Total
$ — $ — $ 243 $ 243
The Level 3 amounts above represent the fair value of the 5% Notes and related accrued interest.
The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts receivable, accounts payable and loan payable. 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. The carrying value of loan payable on the Company’s balance sheet is estimated to approximate its fair value as the interest rate approximates the market rate for loans with similar terms and risk characteristics.
We have no Level 1 or Level 2 instruments. Our Level 3 instrument amounts represent the fair value of the 5% Notes and related accrued interest. The following table summarizes the changes in Level 3 instruments for the years ended December 31, 2023 and 2022 :
(in thousands)
Balance at January 1, 2022
360
Interest accrued on face value of 5 % Notes
1,073
Change in fair value of Level 3 liabilities
( 1,190 )
Balance at December 31, 2022
$ 243
Interest accrued on face value of 5 % Notes
1,133
Change in fair value of Level 3 liabilities
( 1,019 )
Balance at December 31, 2023
$ 357
The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations.
NOTE 6 – STOCKHOLDERS ’ EQUITY
Preferred Stock
Our amended and restated certificate of incorporation authorizes the issuance of up to 10,000,000 shares of preferred stock, $ 0.001 par value, with rights senior to those of our common stock, issuable in one or more series. Upon issuance, we can determine the rights, preferences, privileges and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock.
Stockholder Rights Plan
On July 18, 2014, we adopted a stockholder rights plan. The stockholder rights plan is embodied in the Stockholder Protection Rights Agreement dated as of July 18, 2014 (the Rights Agreement), between us and American Stock Transfer & Trust Company, LLC, as rights agent (the Rights Agent).
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Notes to Consolidated Financial Statements
Accordingly, the Board of Directors declared a distribution of one right (a “Right”) for each outstanding share of common stock, to stockholders of record at the close of business on July 28, 2014, for each share of common stock issued (including shares distributed from Treasury) by us thereafter and prior to the Separation Time (as defined in the Rights Agreement), and for certain shares of common stock issued after the Separation Time. Following the Separation Time, each Right entitles the registered holder to purchase from us one one -thousandth ( 1/1,000 ) of a share of Series A Junior Participating Preferred Stock, par value $ 0.001 per share (the Preferred Stock), at a purchase price of $ 100.00 (the Exercise Price), subject to adjustment. The description and terms of the Rights are set forth in the Rights Agreement. Each one one -thousandth of a share of Preferred Stock has substantially the same rights as one share of common stock. Subject to the terms and conditions of the Rights Agreement, Rights become exercisable ten days after the public announcement that a “Person” has become an “Acquiring Person” (as each such term is defined in the Rights Agreement). Any Rights held by an Acquiring Person are void and may not be exercised.
The Rights Agreement was approved by our Board of Directors on July 18, 2014. The Rights will expire at the close of business on its ten -year anniversary, unless earlier exchanged or terminated by us.
Common Stock
Our amended and restated certificate of incorporation authorizes the issuance of up to 175,000,000 shares of $ 0.001 par value common stock.
On September 5, 2019, we filed an automatic “shelf registration” statement on Form S- 3 (the 2019 WKSI Shelf) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale. The 2019 WKSI Shelf was declared effective in September 2019. In connection with the 2019 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2020 ATM) with Jefferies LLC, Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (each a 2020 Agent and collectively, the 2020 Agents), relating to the sale of shares of our common stock. Under the 2020 ATM, we paid the 2020 Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock. In November 2020, we entered into an At-the-Market Issuance Sales Agreement (the 2021 ATM) with the same terms and agents (each a 2021 Agent and collectively, the 2021 Agents) as the 2020 ATM.
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.
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Notes to Consolidated Financial Statements
On September 2, 2022, we filed an automatic “shelf registration” statement on Form S- 3 (the 2022 WKSI Shelf) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale. The 2022 WKSI Shelf was declared effective in September 2022. In connection with the 2022 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2022 ATM) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (each a 2022 Agent and collectively, the 2022 Agents), relating to the sale of shares of our common stock. Under the 2022 ATM, we will pay the 2022 Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock. The 2022 ATM has replaced the 2021 ATM as the only active ATM program.
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. We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We may need to file additional shelf-registration statements in the future to provide us with the flexibility to raise additional capital to finance our operations as needed.
Treasury Stock
As of December 31, 2023 and 2022 , 41,309 shares of common stock are being held in Treasury, at a cost of approximately $ 0.2 million, representing the fair market value on the date the shares were surrendered to the Company to satisfy employee tax obligations.
Equity Incentive Plans
The TG Therapeutics, Inc. 2022 Incentive Plan (the 2022 Incentive Plan) was approved by stockholders in June 2022 with 17 million shares available to be issued, of which not more than 10 million shares may be issued pursuant to “full-value awards.” Full-value awards include any award other than an option or stock appreciation right and which is settled by the issuance of stock. As of December 31, 2023 , 4,631,204 shares of restricted stock and 2,272,500 options were outstanding, and up to an additional 8,751,892 shares were available to be issued under the 2022 Incentive Plan.
The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020. As of 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.
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. 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.
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Notes to Consolidated Financial Statements
Stock Options
The estimated fair value of the options granted in the years ended December 31, 2023, 2022 and 2021 was determined utilizing the Black-Scholes option-pricing model at the date of grant. The following table summarizes stock option activity for the years ended December 31, 2023, 2022 and 2021 :
Weighted-
average
Weighted-
contractual
Number of
average
term
Aggregate
shares
exercise price
(in years)
intrinsic value
Outstanding at January 1, 2021
2,526,166 6.99 8.10 $ 115,472,832
Granted
— $ —
Exercised
( 52,694 ) 4.10
Forfeited
( 5,935 ) 4.10
Expired
— —
Outstanding at December 31, 2021
2,467,537 $ 7.06 6.99 $ 29,503,551
Granted
2,975,000 7.00
Exercised
( 142,409 ) 4.10
Forfeited
( 164,443 ) 7.84
Expired
— —
Outstanding at December 31, 2022
5,135,685 $ 7.10 5.09 $ 25,064,799
Granted
— —
Exercised
( 246,156 ) 6.08
Forfeited
( 192,500 ) 11.30
Expired
— —
Outstanding at December 31, 2023
4,697,029 $ 6.98 4.10 $ 47,607,209
Exercisable at December 31, 2023
2,133,273 $ 6.60 4.72 $ 22,518,984
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. Stock-based compensation for milestone-based options will be recorded if and when a milestone becomes probable. We did not recognize stock-based compensation expense during the year ended December 31, 2023 for these stock options.
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Notes to Consolidated Financial Statements
The fair value of the Company’s option awards granted in each of the following years were estimated using the assumptions below:
Year Ended
December 31, 2023
December 31, 2022
December 31, 2021
Volatility
N/A 88.37 - 89.67 % N/A
Expected term (in years)
N/A 3.13 - 4.0 N/A
Risk-free rate
N/A 2.99 - 3.35 % N/A
Expected dividend yield
N/A — % N/A
Restricted Stock
Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted share activity for the years ended December 31, 2023, 2022 and 2021 :
Weighted-average
grant date fair
Number of shares
value
Outstanding at January 1, 2021
10,785,034 13.38
Granted
2,738,974 39.49
Vested
( 1,302,737 ) 18.14
Forfeited
( 189,231 ) 21.80
Outstanding at December 31, 2021
12,032,040 18.67
Granted
5,179,201 12.75
Vested
( 6,291,999 ) 11.28
Forfeited
( 2,186,956 ) 22.44
Outstanding at December 31, 2022
8,732,286 16.12
Granted
3,620,237 13.77
Vested
( 2,500,263 ) 11.98
Forfeited
( 213,192 ) 12.14
Outstanding at December 31, 2023
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. As of December 31, 2023 , there was approximately $ 27.8 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 2.7 years. 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. Milestone-based noncash compensation expense will be measured and recorded if and when a milestone becomes probable.
Warrants
The Company’s only outstanding warrants are the warrants issued to Hercules as part of the Loan Agreement, the Amended Loan Agreement and the First Amendment (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. 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.
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Notes to Consolidated Financial Statements
NOTE 7 – LOAN PAYABLE
On February 28, 2019 (the Closing Date), we entered into a term loan facility with Hercules Capital, Inc. (Hercules or Lender), which provided us with the capacity to borrow up to an aggregate principal amount of $ 60.0 million (Term Loan). The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the Loan Agreement), which provides for up to four separate advances. The first advance of $ 30.0 million was drawn on the Closing Date. An additional $ 30.0 million under the Term Loan was previously available upon the completion of different milestones and time points that have now lapsed.
On December 30, 2021 ( the Amended Loan Agreement Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules Capital, Inc. The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $ 60.0 million to $ 200.0 million (the Amended Term Loan), (ii) issue a first advance of $ 70.0 million drawn at the Amended Loan Agreement Closing Date, a portion of which was used to refinance the current outstanding loan balance of approximately $ 7.8 million and pay for expenses incurred by the Lender in executing the agreements, (iii) change the draw amounts and dates available in subsequent tranches, (iv) extend the maturity date of the facility from the original March 1, 2022 to January 1, 2026, ( v) reset and extend the interest only period from April 1, 2021 to February 1, 2025 and extendable to August 1, 2025 subject to the achievement of certain performance milestones, and (vi) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 2.15 %, and (b) 5.40 %. In addition to the cash interest rate, the principal balance 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.
On March 31, 2023 ( the First Amendment Effective Date), the Company entered into a First Amendment to the Amended and Restated Loan and Security Agreement (the First Amendment) with Hercules. The First Amendment amended the terms of the Amended Loan Agreement to, among other things: (i) issue an advance of $ 25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) 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 %. 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. 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. As of December 31, 2023, we are in compliance with all financial covenants.
The First Amendment also contains warrant coverage of 2.95 % of each advance amount funded. 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. 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). The First Amendment Warrant shall be exercisable for seven years from the date of issuance. Hercules may exercise the First Amendment Warrant either by (a) cash or check or (b) through a net issuance conversion
In addition, the Company is required to pay a final payment fee equal to 5.95 % of the aggregate principal amount of the Term Loan Advances (as defined in the Amended Loan Agreement, as amended) plus 4.95 % of the aggregate principal amount of all other advances.
The Company may, at its option, prepay the Amended Term Loan in full or in part, subject to a prepayment penalty equal to (i) 1.5 % of the principal amount prepaid if the prepayment occurs prior to the first anniversary of the First Amendment Effective Date, and (ii) 1.0 % of the principal amount prepaid if the prepayment occurs on or after the first anniversary of the First Amendment Effective Date.
The Company evaluated whether the First Amendment represented a debt modification or extinguishment of the Amended Term Loan in accordance with ASC 470 - 50, Debt – Modifications and Extinguishments. As a result of the modification of terms and no repayment or retirement of the Amended Term Loan, the Amended Term Loan was accounted for by the Company under the modification accounting model. The Company capitalized the facility charge from the First Amendment advance to debt issuance costs and expensed third party fees in the Company’s statement of operations for the year ended December 31, 2023.
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Notes to Consolidated Financial Statements
The Company estimated the fair value of the Warrant using the Black-Scholes model based on the following key assumptions:
The First Amendment
The Amended Loan Agreement
The Loan Agreement
Exercise price
$ 14.70 $ 17.95 $ 4.08
Common share price on date of issuance
$ 15.04 $ 19.35 $ 6.80
Volatility
0.88 % 184.40 % 195.90 %
Risk-free interest rate
3.6 % 1.4 % 2.6 %
Expected dividend yield
— % — % — %
Contractual term (in years)
7.00 7.00 7.00
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. At December 31, 2023 , the remaining unamortized balance of debt issuance costs was $ 5.1 million.
The loan payable as of December 31, 2023 and 2022 , is as follows:
December 31,
December 31,
(in thousands)
2023
2022
Loan payable
$ 95,000 $ 70,000
Add: Accreted Liability of final payment fee
10,230 6,667
105,230 76,667
Less: unamortized debt issuance costs
( 5,112 ) ( 5,532 )
100,118 71,135
Less: principal payments
— —
Total loan payable
100,118 71,135
Less: current portion
— —
Loan payable non-current
$ 100,118 $ 71,135
NOTE 8 – LEASES
In October 2014, we entered into an agreement (the Office Agreement) with Fortress Biotech, Inc. (FBIO) to occupy approximately 45 % of the 24,000 square feet of New York City office space leased by FBIO. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15 -year lease. We approximate an average annual rental obligation of $ 1.8 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. At January 1, 2019, we recognized a lease liability and corresponding right-of-use (ROU) asset of $ 9.5 million and $ 8.1 million, respectively, based on the present value of the remaining lease payments for all of our leased office spaces, the majority of which is comprised of our New York City office space. The present values of our lease liability and corresponding ROU asset are $ 10.7 million and $ 8.1 million, respectively, as of December 31, 2023 . Our leases have remaining lease terms of approximately 2 years to 8 years. One lease has a renewal option to extend the lease for an additional term of five years.
Also, in connection with this lease, in October 2014 we pledged $ 0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets. Additional collateral of $ 0.6 million was pledged in April 2018 to increase the letter of credit for the office space.
In October 2019, we finalized a five -year lease for office space in New Jersey (the NJ Lease). We approximate an average annual rental obligation of $ 0.3 million under the NJ Lease.
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Notes to Consolidated Financial Statements
In October 2021, we finalized a five -year lease for office space in North Carolina (the NC Lease). We approximate an average annual rental obligation of $ 0.2 million under the NC Lease. We took possession of this space in February 2022, with rental payments beginning in April 2022.
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 %. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2023 was $ 2.4 million.
The balance sheet classification of lease liabilities was as follows:
December 31,
December 31,
(in thousands)
2023
2022
Liabilities
Lease liability current portion
$ 1,446 $ 1,581
Lease liability non-current
9,231 10,344
Total lease liability
$ 10,677 $ 11,925
As of December 31, 2023 , the maturities of lease liabilities were as follows:
Operating
leases
2024
$ 2,388
2025
2,100
2026
2,080
2027
1,913
2028
1,827
After 2028
4,715
Total lease payments
15,023
Less: interest
( 4,346 )
Present value of lease liabilities(*)
$ 10,677
(*) As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date and considering the term of the lease to determine the present value of lease payments. We used the incremental borrowing rate of 10.25 % on February 28, 2019, for leases that commenced prior to that date through December 31, 2021. We used an incremental borrowing rate of 5.65 % for the NC lease.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NOTE 9 – INCOME TAXES
We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. In determining the need for a valuation allowance, management reviews both positive and negative evidence, including current and historical results of operations, future income projections and the overall prospects of our business. Based upon management's assessment of all available evidence, we believe that it is more-likely-than- not that the deferred tax assets will not be realizable, and therefore, a valuation allowance has been established. The valuation allowance for deferred tax assets was approximately $ 418.3 million and $ 400.4 million as of December 31, 2023 and 2022 , respectively.
The Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174. Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred. 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. and 15 years for costs incurred in a non-U.S. jurisdiction. The Company incurred approximately $ 61.8 million of U.S. research and development costs and approximately $ 13.9 million of non-U.S. 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. The IRA provided for a Corporate Alternative Minimum Tax (Corp AMT), applicable to tax years beginning after December 31, 2022. The Corp AMT will impose a 15% tax on companies with adjusted financial statement income of over $1 billion for US-based organizations. At this time, it is not anticipated that the Corp AMT will be applicable for the Company.
As of December 31, 2023 , we have U.S. net operating loss carryforwards of approximately $ 1.4 billion , research and development credit carryforwards (R&D credits) of approximately $ 45.8 million and business interest expense carryforward of $ 14.5 million. For income tax purposes, these NOLs and R&D credits will expire in various amounts through 2040. NOLs generated after 2017 and the business interest expense carryforwards do not expire. The Tax Reform Act of 1986 contains provisions which limit the ability to utilize net operating loss carryforwards and R&D credit carryforwards in the case of certain events including significant changes in ownership interests. The Exchange Transaction with TG Bio may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Additionally, stock issuance activities may have resulted in a “change in ownership” as defined by IRC Section 382 of the Internal Revenue Code of 1986, as amended. Accordingly, a substantial portion of the Company’s NOLs above may be subject to annual limitations in reducing any future year’s taxable income, and a substantial portion of the R&D Credit carryforwards may be subject to annual limitations in reducing any future year’s tax.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2023 and 2022 are presented below.
(in thousands)
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$ 316,962 $ 303,729
Research and development credit
45,806 42,031
Noncash compensation
12,275 10,325
Disallowed interest
3,328 3,882
Capitalized R&D Expenses
36,613 39,411
Other
3,333 985
Deferred tax asset, excluding valuation allowance
418,317 400,363
Less valuation allowance
( 418,317 ) ( 400,363 )
Net deferred tax assets
$ — $ —
There was approximately $ 0.4 million of current income tax expense for the year ended December 31, 2023 . 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,
(in thousands)
2023
2022
2021
Loss before income taxes, as reported in the consolidated statements of operations
$ 13,062 $ ( 198,335 ) $ ( 348,101 )
Computed “expected” tax benefit
$ 2,743 $ ( 41,650 ) $ ( 73,101 )
Increase (decrease) in income taxes resulting from:
Expected benefit from state and local taxes
111 ( 7,242 ) ( 3,445 )
Research and development credits
( 3,430 ) ( 6,389 ) ( 8,337 )
Officer Compensation Limitation
1,167 4,391 439
Other
( 179 ) 374 428
Stock options
( 12,445 ) 17,599 ( 6,726 )
Change in state tax rates
( 5,531 ) - -
Change in the balance of the valuation allowance for deferred tax assets
17,954 32,917 90,742
$ 390 $ — $ —
We file income tax returns in the U.S federal and various state and local jurisdictions. With certain exceptions, the Company is no longer subject to U.S. federal and state income tax examinations by tax authorities for years prior to 2020. However, NOLs and tax credits generated from those prior years could still be adjusted upon audit.
The Company would recognize interest and penalties, if any, to uncertain tax position in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2023 . We do not believe that there will be a material change in our unrecognized tax positions over the next twelve months. All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NOTE 10 – LICENSE AGREEMENTS
BRIUMVI (Ublituximab)
In January 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the LFB License Agreement). Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. 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. 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. 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. 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. Ltd. (Ildong) relating to the development and commercialization of ublituximab in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar.
An upfront payment of $ 2.0 million, which was received in December 2012, net of $ 0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement. We recorded license revenue of approximately $ 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.
In July 2023, the Company entered into the Commercialization Agreement with Neuraxpharm. 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. 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). 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. In addition, TG will receive tiered double-digit royalties on net product sales up to 30 %. 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.
TG- 1701: BTK
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 ). Hengrui is eligible to receive milestone payments totaling approximately $ 350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. In July 2020, we paid Hengrui $ 2.0 million as part of a milestone in accordance with the license agreement. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
TG- 1801: anti- CD47/anti - CD19
In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune to collaborate on the development and commercialization of Novimmune’s novel first -in-class anti- CD47/anti - CD19 bispecific antibody known as TG- 1801 (previously NI- 1701 ). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG- 1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $ 185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones.
UKONIQ (umbralisib)
On September 22, 2014, we exercised our option to license the global rights to umbralisib, thereby entering into an exclusive licensing agreement (the TGR- 1202 License) with Rhizen Pharmaceuticals, SA (Rhizen) for the development and commercialization of umbralisib. 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. For the year ended December 31, 2021, we paid Rhizen $ 12.0 million as part of a primary indication approval milestone for launch of product in the US in accordance with the terms of the Umbralisib License. Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib. UKONIQ was officialy withdrawn from the market in May 2022 and all commercialization activities were discontinued. 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. sales of UKONIQ, and as of December 31, 2023, no royalties were payable under the Umbralisib License. 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.
TG- 1501: Cosibelimab
In March 2015, we entered into a Global Collaboration Agreement (Collaboration Agreement) with Checkpoint for the development and commercialization of anti-PD- L1 and anti-GITR antibody research programs in the field of hematological malignancies. The Collaboration Agreement was amended in June 2019 and in March of 2020. 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.
NOTE 11 – RELATED PARTY TRANSACTIONS
In July 2015, we entered into a Shared Services Agreement (the Shared Services Agreement) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. This Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $ 0.9 million, $ 1.3 million and $ 0.9 million for shared services for the years ended December 31, 2023, 2022 and 2021 , respectively, primarily related to shared personnel. Mr. Weiss, our Chairman and Chief Executive Officer, also serves as a director and Executive Vice Chairman, Strategic Development of FBIO.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
In March 2015, we entered into the Collaboration Agreement with Checkpoint, a subsidiary of FBIO, for the development and commercialization of anti-PD- L1 and anti-GITR antibody research programs in the field of hematological malignancies. In May 2016, as part of a broader agreement with Jubilant, we entered into a sublicense agreement (JBET Agreement) with Checkpoint for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. Mr. Weiss also serves as Chairman of the Board of Directors of Checkpoint.
Please refer to Note 8 - Leases for details regarding the Office Agreement with FBIO, as well as Note 10 - License Agreements for details regarding the Collaboration Agreement with Checkpoint.
NOTE 12 – COMMITMENTS AND CONTINGENCIES
As of December 31, 2023 , we have known contractual obligations; commitments and contingencies of $ 115.4 million related to our short- and long-term liabilities and operating lease obligations.
Less than
More than
Payment due by period (in thousands)
Total
1 year
1-3 years
3-5 years
5 years
Contractual obligations
Operating leases
$ 15,023 $ 2,388 $ 4,180 $ 3,740 $ 4,715
Long-term debt
100,403 — 100,403 — —
Total
$ 115,426 $ 2,388 $ 104,583 $ 3,740 $ 4,715
Leases
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.
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 .
Loan Payable
See Note 7 – Loan payable for a detail description of our loan agreement.
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NOTE 13 – Subsequent Events
Precision Bio
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. ( 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 ).
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. 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. 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. 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. 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. The Company has also agreed to make certain payments to Precision’s licensors during the term of the Precision License Agreement.
Ex-U.S. BRIUMVI Launch
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. The launch commenced in Germany, with additional launches throughout Europe to follow. 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.
SIGNATURES
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.
Date: February 29, 2024
By:
/s/ Michael S. Weiss
Michael S. Weiss
Chairman and Chief Executive Officer
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POWER OF ATTORNEY
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.
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:
Signatures
Title
/s/ Michael S. Weiss
Michael S. Weiss
Chairman, Chief Executive Officer and President
/s/ Sean A. Power
Sean A. Power
Chief Financial Officer, Treasurer and Corporate Secretary
/s/ Laurence N. Charney
Laurence N. Charney
Director
/s/ Yann Echelard
Yann Echelard
Director
/s/ Kenneth Hoberman
Kenneth Hoberman
Director
/s/ Daniel Hume
Daniel Hume
Director
/s/ Sagar Lonial
Sagar Lonial
Director
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