71 unchanged sentences
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).
−Removed: TG Therapeutics, Inc.
−Removed: Amended and Restated 2012 Incentive Plan, dated May 14, 2012 (incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-Q/A for the quarter ended March 31, 2012).
−Removed: First Amendment to TG Therapeutics, Inc.
−Removed: Amended and Restated 2012 Incentive Plan, filed with the Registrant’s Definitive Proxy Statement for the Annual Meeting of Stockholders on June 4, 2015, filed on April 24, 2015, and incorporated herein by reference.
−Removed: Second Amendment to TG Therapeutics, Inc.
−Removed: Amended and Restated 2012 Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on June 24, 2020).
Sublicense Agreement between TG Therapeutics, Inc.
12 unchanged sentences
Weiss (incorporated by reference to Exhibit 10.18 to the Registrant’s Form 10-K/A for the year ended December 31, 2016).
−Removed: Advisory Agreement, effective January 1, 2017, between TG Therapeutics, Inc.
−Removed: and Caribe BioAdvisors, LLC (incorporated by reference to Exhibit 10.19 to the Registrant’s Form 10-K/A for the year ended December 31, 2016).
License Agreement between TG Therapeutics, Inc.
20 unchanged sentences
and Hercules Capital, Inc.
+Added: (incorporated by reference to Exhibit 10.28 to the Registrant’s Form 10-K for the year ended December 31, 2021).
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc.
and Hercules Capital Inc.
+Added: (incorporated by reference to Exhibit 10.29 to the Registrant’s Form 10-K for the year ended December 31, 2021).
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc.
and Hercules Private Credit Fund I L.P.
+Added: (incorporated by reference to Exhibit 10.30 to the Registrant’s Form 10-K for the year ended December 31, 2021).
Warrant Agreement, dated December 30, 2021, by and between TG Therapeutics, Inc.
and Hercules Private Global Venture Growth Fund I L.P.
+Added: (incorporated by reference to Exhibit 10.31 to the Registrant’s Form 10-K for the year ended December 31, 2021).
+Added: TG Therapeutics, Inc.
+Added: 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).
Subsidiaries of TG Therapeutics, Inc.
1 unchanged sentence
Consent of Independent Registered Public Accounting Firm (CohnReznick LLP).
+Added: Power of Attorney (included in signature page).
Certification of Principal Executive Officer.
21 unchanged sentences
Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheet of TG Therapeutics, Inc.
−Removed: and subsidiaries (the Company) as of December 31, 2021, the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2021, and the related notes (collectively, the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year ended December 31, 2021, in conformity with U.S.
+Added: We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc.
+Added: and subsidiaries (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2022, in conformity with U.S.
generally accepted accounting principles.
2 unchanged sentences
These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
+Added: 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.
−Removed: We conducted our audit in accordance with the standards of the PCAOB.
+Added: 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.
−Removed: Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: 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.
−Removed: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
−Removed: Critical Audit Matters
−Removed: Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit matters.
+Added: 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.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
+Added: 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:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: 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.
+Added: Liquidity and capital resources
+Added: As discussed in Note 1 to the consolidated financial statements, the Company's sources of cash have primarily been proceeds from private placement and public offering of equity securities, and from its loan and security agreements.
+Added: The Company has incurred operating losses since inception.
+Added: The Company’s ability to achieve profitability depends on its ability to generate revenue and many other internal and external factors.
+Added: The Company may continue to incur substantial operating losses even if the Company begins to generate revenue from its drug candidates.
+Added: The Company believes that its cash and cash equivalents, investment securities, capital contractually available under its existing Amended Loan Agreement, and forecasted revenue will provide the Company with sufficient liquidity for more than a twelve-month period from the date the consolidated financial statements are issued.
+Added: As of December 31, 2022, the Company had $174.1 million in cash and cash equivalents, and investment securities, and $45.0 million of capital available under its Amended Loan Agreement.
+Added: We identified the evaluation of the Company’s assessment of its liquidity and capital resources and related disclosures as a critical audit matter.
+Added: Significant auditor judgment was required to evaluate the forecasted revenue used in the Company’s forecasted cash flows analysis for the twelve-month period subsequent to issuance of the consolidated financial statements.
+Added: The following are the primary procedures we performed to address this critical audit matter.
+Added: We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s assessment of its ability to continue as a going concern, including the development of the forecasted revenue over the twelve-month period following the date the consolidated financial statements are issued.
+Added: To assess the Company’s ability to forecast revenue, we compared the Company's forecasted revenue with available external industry data and other internal information.
+Added: We performed sensitivity analyses over the Company’s going concern assessment by evaluating the effect of changes to the forecasted revenue.
+Added: We evaluated the reasonableness of the Company’s forecasted revenue by comparing it to management’s stated plans which were corroborated by meeting minutes of the Board of Directors.
+Added: We assessed the Company’s disclosures related to its going concern assessment by comparing the disclosures to the audit evidence obtained.
We have served as the Company’s auditor since 2021.
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In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheet of the Company as of December 31, 2021, the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2021, and the related notes (collectively, the consolidated financial statements), and our report dated March 1, 2022 expressed an unqualified opinion on those consolidated financial statements.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements), and our report dated March 1, 2023 expressed an unqualified opinion on those consolidated financial statements.
Basis for Opinion
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Opinion on th e Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of TG Therapeutics, Inc.
−Removed: (the “Company”) as of December 31, 2020, and the rel ated consolidated statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively referred to as the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
+Added: We have audited the accompanying consolidated statements of operations, stockholders’ equity and cash flows of TG Therapeutics, Inc.
+Added: (the “Company”) for the period ended December 31, 2020, and the related notes (collectively referred to as the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the results of its operations and its cash flows for the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
−Removed: 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.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
+Added: 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 the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: 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.
+Added: Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: 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.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matter
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( 1,527,033 )
+Added: ( 1,328,698 )
Total stockholders’ equity
11 unchanged sentences
Research and development:
−Removed: Noncash stock expense associated with in-licensing agreements
Noncash compensation
19 unchanged sentences
Balance at January 1, 2020
+Added: Issuance of common stock in connection with exercise of options
Issuance of restricted stock
−Removed: Warrants issued with debt financing
Forfeiture of restricted stock
2 unchanged sentences
Compensation in respect of restricted stock granted to employees, directors and consultants
−Removed: Shares issued in connection with in-licensing agreements
Balance at December 31, 2020
1 unchanged sentence
Issuance of restricted stock
+Added: Warrants issued with debt financing
Forfeiture of restricted stock
−Removed: Issuance of common stock in offerings (net of offering costs of $ 29.9 million)
+Added: Offering Costs Paid
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.1 million)
1 unchanged sentence
Balance at December 31, 2021
+Added: ( 1,328,698 )
Issuance of common stock in connection with exercise of options
Issuance of restricted stock
−Removed: Warrants issued with debt financing
Forfeiture of restricted stock
−Removed: Offering costs paid
−Removed: Issuance of common stock in At-the-Market offerings (net of offering costs of $ 0.1 million)
+Added: ( 2,186,956 )
Compensation in respect of restricted stock granted to employees, directors and consultants
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Noncash stock compensation expense
−Removed: Shares issued in connection with in-licensing agreement
Depreciation and amortization
−Removed: Amortization of premium on investment securities
+Added: Amortization of premium (discount) on investment securities
Amortization of debt issuance costs
3 unchanged sentences
Changes in assets and liabilities:
−Removed: (Increase) decrease in other current assets
−Removed: Increase in accounts receivable
−Removed: Increase (decrease) in accounts payable and accrued expenses
+Added: Decrease (increase) in other current assets
+Added: Decrease (increase) in accounts receivable
+Added: (Decrease) increase in accounts payable and accrued expenses
Decrease in lease liabilities
−Removed: (Decrease) increase in other current liabilities
+Added: Increase (decrease) in other current liabilities
Decrease in deferred revenue
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Proceeds from debt financings
−Removed: Financing costs paid
−Removed: Net cash provided by financing activities
+Added: Offering costs paid
+Added: Net cash (used in) provided by financing activities
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
−Removed: Reconciliation to amounts on consolidated balance sheets:
+Added: Reconciliation to amounts on condensed consolidated balance sheets:
Cash and cash equivalents
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Cash paid for:
−Removed: NONCASH TRANSACTIONS
−Removed: Deferred financing costs
−Removed: Warrants issued with debt financing
−Removed: Shares issued in connection with in-licensing
The accompanying notes are an integral part of the consolidated financial statements.
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DESCRIPTION OF BUSINESS
−Removed: TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.
−Removed: In addition to an active research pipeline including five investigational medicines across these therapeutic areas, we have received accelerated approval from the U.S.
−Removed: Food and Drug Administration (FDA) for UKONIQ ® (umbralisib), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapies.
−Removed: Currently, we have three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development.
+Added: TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.
+Added: In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S.
+Added: Food and Drug Administration (FDA) for BRIUMVI™ (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
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(Hercules) (see Note 6 for more information).
−Removed: In February of 2021, umbralisib, now referred to as UKONIQ, was granted accelerated approval in the United States for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapy.
−Removed: Commercial sales of UKONIQ commenced in the first quarter of 2021.
−Removed: We have generated limited revenues to date from product sales.
−Removed: Even with the commercialization of UKONIQ and the potential future commercialization of our other drug candidates, we may not become profitable.
−Removed: Our ability to achieve profitability depends on many factors, including our ability to generate revenue, our ability to obtain regulatory approvals for our drug candidates, our ability to successfully complete any post-approval regulatory obligations and our ability to successfully commercialize our drug candidates.
−Removed: We may continue to incur substantial operating losses even as we begin to generate revenues from product sales.
+Added: Since inception, we have incurred significant operating losses.
+Added: 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.
+Added: As of December 31, 2022, we had not yet generated revenue from drug sales of BRIUMVI.
+Added: BRIUMVI first became commercially available in the United States in January of 2023.
+Added: Even with the commercialization of BRIUMVI and the future commercialization of our other drug candidates, we may not become profitable.
+Added: Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates;
+Added: successfully complete any post-approval regulatory obligations;
+Added: and successfully commercialize our drug candidates alone or in partnership.
+Added: We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates.
As of December 31, 2022, we had $ 174.1 million in cash and cash equivalents, and investment securities.
−Removed: We anticipate that our cash and cash equivalents, and investment securities as of December 31, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.
−Removed: The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for our drug candidates.
−Removed: We are dependent upon significant future financing to provide the cash necessary to execute our current operations, including the commercialization of any of our drug candidates.
+Added: We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2022, capital contractually available under our existing Amended Loan Agreement, and forecasted revenue, will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.
+Added: The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our BRIUMVI commercialization efforts, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates.
+Added: We are dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any of our drug candidates.
Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.”
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Notes to Consolidated Financial Statements
−Removed: As of December 31, 2021, the Company has not received any returns.
+Added: As of December 31, 2022, the Company has received $ 0.6 million in returns as a result of the market withdrawal of UKONIQ.
Co-Payment Assistance Programs:
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We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles.
−Removed: As of December 31, 2021, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances.
+Added: As of December 31, 2022, due to the product withdrawal in April of 2022, there are no outstanding net receivables from customers.
COST OF PRODUCT REVENUE
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In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon achievement of certain milestones, the total expense is uncertain.
−Removed: Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable.
+Added: Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones occurs.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
BASIC AND DILUTED NET LOSS PER COMMON SHARE
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therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
The following table summarizes our potentially dilutive securities at December 31, 2022, 2021 and 2020:
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There was no impairment to goodwill as of December 31, 2022.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
NOTE 2 - REVENUE RECOGNITION
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sales of UKONIQ, which we began shipping to our customers in February 2021.
+Added: The voluntary withdrawal of UKONIQ from the U.S.
+Added: market was announced on April 15, 2022.
+Added: Effective May 31, 2022, UKONIQ was officially withdrawn from the market.
We record our best estimate for sales discounts and allowances to which customers are likely to be entitled.
1 unchanged sentence
(in thousands)
−Removed: December 31, 2021
Gross product revenue
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Net product revenue
−Removed: (1) As of December 31, 2021, approximately $ 0.4 million of estimated gross-to-net-accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the consolidated balance sheets.
+Added: (1) As of December 31, 2022 and 2021, approximately $ 0.2 million and $ 0.4 million of estimated gross-to-net-accruals have been recorded as a reduction of accounts receivable, net and within accounts payable and accrued expenses on the consolidated balance sheets.
TG Therapeutics, Inc.
6 unchanged sentences
December 31, 2022
−Removed: Estimated fair
(in thousands)
2 unchanged sentences
Short-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between January 2022 and April 2022) (held-to-maturity)
+Added: Obligations of domestic governmental agencies (maturing between January 2023 and December 2023) (held-to-maturity)
Long-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity)
+Added: Obligations of domestic governmental agencies (maturing between January 2024 and February 2024) (held-to-maturity)
Total short-term and long-term investment securities
December 31, 2021
−Removed: Amortized cost, as adjusted
−Removed: Gross unrealized holding gains
−Removed: Gross unrealized holding losses
−Removed: Estimated fair value
+Added: Estimated fair
+Added: holding gains
+Added: holding losses
Short-term investments:
−Removed: Obligations of domestic governmental agencies (maturing between January 2021 and December 2021) (held-to-maturity)
−Removed: Total short-term investment securities
+Added: Obligations of domestic governmental agencies (maturing between January 2022 and April 2022) (held-to-maturity)
Long-term investments:
−Removed: Obligations of domestic governmental agencies (held-to-maturity)
−Removed: Total long-term investment securities
+Added: Obligations of domestic governmental agencies (maturing between February 2023 and June 2023) (held-to-maturity)
+Added: Total short-term and long-term investment securities
NOTE 4 – FAIR VALUE MEASUREMENTS
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As of December 31, 2022 and 2021, the fair values of cash and cash equivalents, restricted cash, accounts receivable, and notes and interest payable approximate their carrying value.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
At the time of our merger (we were then known as Manhattan Pharmaceuticals, Inc.
3 unchanged sentences
We have no obligations under the 5% Notes aside from the conversion feature.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2022 and 2021:
15 unchanged sentences
The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
NOTE 5 – STOCKHOLDERS’ EQUITY
1 unchanged sentence
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.
−Removed: Upon issuance, the Company can determine the rights, preferences, privileges and restrictions thereof.
+Added: 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.
2 unchanged sentences
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).
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: 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.
7 unchanged sentences
Our amended and restated certificate of incorporation authorizes the issuance of up to 175,000,000 shares of $ 0.001 par value common stock.
−Removed: In May 2017, we filed a shelf registration statement on Form S-3 (the 2017 S-3), which was declared effective in June 2017, replacing the 2015 S-3.
−Removed: Under the 2017 S-3, we may sell up to a total of $ 300 million of securities.
−Removed: In connection with the 2017 S-3, we entered into an At-the-Market Issuance Sales Agreement (the 2017 ATM) with Jefferies LLC, Cantor Fitzgerald & Co., FBR Capital Markets & Co., SunTrust Robinson Humphrey, Inc., Raymond James & Associates, Inc., Ladenburg Thalmann & Co.
−Removed: Wainwright & Co., LLC (each a "2017 Agent"
−Removed: and collectively, the 2017 Agents), relating to the sale of shares of our common stock.
−Removed: Under the 2017 ATM we pay the 2017 Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
−Removed: During the year ended December 31, 2019, we sold a total of 13,620,165 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $ 99.3 million at an average selling price of $ 7.29 per share, resulting in net proceeds of approximately $ 97.5 million after deducting commissions and other transactions costs.
−Removed: On March 1, 2019, we completed a public offering of 4,100,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 615,000 shares of common stock, which was exercised) at a price of $ 5.87 per share.
−Removed: Net proceeds from this offering, including the overallotment, were approximately $ 27.5 million after underwriting discounts and offering expenses of approximately $ 0.2 million.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
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.
3 unchanged sentences
(each a 2020 Agent and collectively, the 2020 Agents), relating to the sale of shares of our common stock.
−Removed: Under the 2020 ATM, we pay the 2020 Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of common stock.
+Added: 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.
2 unchanged sentences
During the year ended December 31, 2021, we sold a total of 72,000 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $ 2.5 million at an average selling price of $ 34.25 per share, resulting in net proceeds of approximately $ 2.4 million after deducting commissions and other transactions costs.
−Removed: On December 22, 2019, we completed a securities purchase agreement with an institutional investor in which we agreed to sell 5,434,783 shares of our common stock at a price of $ 9.20 per share.
−Removed: Net proceeds from this offering were approximately $ 50.0 million.
In May 2020, we completed an underwritten public offering of 8,500,000 shares of our common stock (plus an underwriter option to purchase up to an additional 1,275,000 shares of common stock, which was exercised) at a price of $ 18 per share.
2 unchanged sentences
Net proceeds from this offering, including the overallotment, were approximately $ 297.2 million after underwriting discounts and offering expenses of approximately $ 19.0 million.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
+Added: 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.
+Added: The 2022 WKSI Shelf was declared effective in September 2022.
+Added: In connection with the 2022 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2022 ATM) with Cantor Fitzgerald & Co.
+Added: Riley Securities, Inc.
+Added: (each a 2022 Agent and collectively, the 2022 Agents), relating to the sale of shares of our common stock.
+Added: 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.
+Added: The 2022 ATM has replaced the 2021 ATM as the only active ATM program.
+Added: We had no activity on the 2021 ATM or 2022 ATM during the year ended December 31, 2022.
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.
−Removed: We believe that the 2019 WKSI Shelf provides us with the flexibility to raise additional capital to finance our operations as needed.
+Added: 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
2 unchanged sentences
The TG Therapeutics, Inc.
−Removed: Amended and Restated 2012 Incentive Plan (2012 Incentive Plan) was approved by stockholders in June 2020.
−Removed: Pursuant to this amendment, 8,000,000 shares were added to the 2012 Incentive Plan.
−Removed: As of December 31, 2021 and 2020, 12,032,040 and 10,785,034 shares of restricted stock and 2,467,537 and 2,526,166 options, respectively, were outstanding and up to an additional 1,511,105 shares may be issued under the 2012 Incentive Plan.
+Added: 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.
+Added: As of December 31, 2022, 2,196,097 shares of restricted stock and 2,290,000 options were outstanding, and up to an additional 12,251,485 shares were available to be issued under the 2022 Incentive Plan.
+Added: The TG Therapeutics, Inc.
+Added: Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020.
+Added: As of December 31, 2022, 6,536,189 shares of restricted stock and 2,845,685 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.
TG Therapeutics, Inc.
2 unchanged sentences
Stock Options
−Removed: The estimated fair value of the options granted in the year ended December 31, 2020 and 2019 was determined utilizing the Black-Scholes option-pricing model at the date of grant.
+Added: The estimated fair value of the options granted in the years ended December 31, 2022, 2021 and 2020 was determined utilizing the Black-Scholes option-pricing model at the date of grant.
The following table summarizes stock option activity for the years ended December 31, 2022, 2021 and 2020:
7 unchanged sentences
Total ex pense associated with the stock options was approximately $ 3.3 million, $ 2.9 million and $ 6.0 million during the years ended December 31, 2022, 2021 and 2020, respectively.
−Removed: As of December 31, 2021, there was approximately $ 0.2 million of total unrecognized compensation cost related to unvested time-based stock options, which is expected to be recognized over a weighted-average period of 1.0 year.
+Added: As of December 31, 2022, there was approximately $ 8.0 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 3.3 years.
As of December 31, 2022, the stock options outstanding include options granted to both employees and non-employees which are both time-based and milestone-based.
1 unchanged sentence
We recognized stock-based compensation expense of $ 1.2 million during the year ended December 31, 2022 for these stock options.
−Removed: We did not grant any options for the year ended December 31, 2021.
−Removed: The fair value of the Company’s option awards were estimated using the assumptions below:
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
+Added: The fair value of the Company’s option awards granted in each of the following years were estimated using the assumptions below:
December 31, 2022
December 31, 2021
+Added: December 31, 2020
88.37 - 89.67
+Added: 186.91 - 191.05
Expected term (in years)
1 unchanged sentence
Expected dividend yield
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
Restricted Stock
6 unchanged sentences
Outstanding at January 1, 2020
+Added: ( 1,087,918 )
Outstanding at December 31, 2020
2 unchanged sentences
( 6,291,999 )
+Added: ( 2,186,956 )
Outstanding at December 31, 2022
Total compensation expense associated with restricted stock grants was $ 15.8 million, $ 58.4 million and $ 74.2 million during the years ended December 31, 2022, 2021 and 2020, respectively.
−Removed: As of December 31, 2021, there was approximately $ 50.7 million of total unrecognized compensation expense related to unvested time-based restricted stock, which is expected to be recognized over a weighted-average period of 1 year .
+Added: As of December 31, 2022, there was approximately $ 29.2 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 2.6 years.
This amount does not include, as of December 31, 2022, 1,961,258 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones.
−Removed: and 1,088,750 shares of restricted stock outstanding issued to non-employees.
−Removed: Milestone-based noncash compensation expense will be measured and recorded if and when a milestone becomes probable.
+Added: Milestone-based noncash compensation expense will be measured and recorded if and when a milestone occurs.
The Company’s only outstanding warrants are the warrants issued to Hercules as part of our debt agreement to purchase 147,058 and 115,042 shares of common stock with exercise prices of $ 4.08 and $ 17.95 , respectively.
1 unchanged sentence
There will not be any ongoing stock compensation expense volatility associated with these warrants.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
NOTE 6 – LOAN PAYABLE
5 unchanged sentences
On December 30, 2021 (the First Amendment Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules Capital, Inc.
−Removed: The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $ 60.0 million to $ 200.0 million (the Amended Term Loan), (ii) issue a first advance of $ 70.0 million drawn at the First Amendment Closing date, a portion of which was used to refinance the current outstanding loan balance of approximately $ 7.8 million and pay for expenses incurred by the Lender in executing the agreements, (iii) change the draw amounts and dates available in Tranche 2 through Tranche 4 including increasing the amount available under Tranche 2 subject to the achievement of performance milestones from $ 10.0 million to
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
−Removed: $ 20.0 million, increasing the amount available under Tranche 3 subject to the achievement of performance milestones from $ 10.0 million to $ 45.0 million, and increasing the amount under Tranche 4 subject to the approval of Hercules’ investment committee from $ 10.0 million to $ 65.0 million, (iv) extend the maturity date of the facility from the original March 1, 2022 to January 1, 2026, (v) reset and extend the interest only period from April 1, 2021 to February 1, 2025 and extendable to August 1, 2025 subject to the achievement of certain performance milestones, and (vi) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 2.15 %, and (b) 5.40 %.
+Added: The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $ 60.0 million to $ 200.0 million (the Amended Term Loan), (ii) issue a first advance of $ 70.0 million drawn at the First Amendment Closing date, a portion of which was used to refinance the current outstanding loan balance of approximately $ 7.8 million and pay for expenses incurred by the Lender in executing the agreements, (iii) change the draw amounts and dates available in Tranche 2 through Tranche 4 including increasing the amount available under Tranche 2 subject to the achievement of performance milestones from $ 10.0 million to $ 20.0 million, increasing the amount available under Tranche 3 subject to the achievement of performance milestones from $ 10.0 million to $ 45.0 million, and increasing the amount under Tranche 4 subject to the approval of Hercules’ investment committee from $ 10.0 million to $ 65.0 million, (iv) extend the maturity date of the facility from the original March 1, 2022 to January 1, 2026, (v) reset and extend the interest only period from April 1, 2021 to February 1, 2025 and extendable to August 1, 2025 subject to the achievement of certain performance milestones, and (vi) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 2.15 %, and (b) 5.40 %.
The performance milestones are based on achievement of certain U.S.
10 unchanged sentences
The Company recorded a loss on extinguishment of debt of approximately $ 0.2 million on the Company’s statement of operations for the twelve months ended December 31, 2021, representing the write-off of deferred financing costs.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: 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:
5 unchanged sentences
Contractual term (in years)
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
The Company incurred financing expenses of $ 7.4 million (including the fair value of the Warrant) related to the Amended Loan Agreement which are recorded as debt issuance costs and as an offset to loan payable on the Company’s consolidated balance sheet.
4 unchanged sentences
(in thousands)
−Removed: End of term fee
+Added: Accreted Liability of final payment fee
unamortized debt issuance costs
13 unchanged sentences
One lease has a renewal option to extend the lease for an additional term of five years .
−Removed: The initial commitment period of the 45 % rate was for a period of three ( 3 ) years.
−Removed: We and FBIO currently determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges.
−Removed: As of December 31, 2021, the allocation rate is 63 % and will be evaluated again in August 2022 for the following rent year.
Also, in connection with this lease, in October 2014 we pledged $ 0.6 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets.
2 unchanged sentences
We approximate an average annual rental obligation of $ 0.3 million under the NJ Lease.
−Removed: We took possession of this space in October 2019, with rental payments beginning in November 2019.
−Removed: In October 2021, we finalized a five-year lease for office space in North Carolina (the NC Lease).
−Removed: We approximate an average annual rental obligation of $ 0.2 million under the NC Lease.
−Removed: We took possession of this space in February 2022, with rental payments beginning in April 2022.
TG Therapeutics, Inc.
1 unchanged sentence
Notes to Consolidated Financial Statements
+Added: In October 2021, we finalized a five-year lease for office space in North Carolina (the NC Lease).
+Added: We approximate an average annual rental obligation of $ 0.2 million under the NC Lease.
+Added: We took possession of this space in February 2022, with rental payments beginning in April 2022.
The following components of lease expense are included in the Company’s consolidated statements of operations for the years ended December 31, 2022, 2021, and 2020:
14 unchanged sentences
(*) 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.
−Removed: We used the incremental borrowing rate of 10.25 % on February 28, 2019, for all operating leases, including those that commenced prior to that date.
+Added: 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.
+Added: We used an incremental borrowing rate of 5.65 % for the NC lease.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
NOTE 8 – INCOME TAXES
5 unchanged sentences
The valuation allowance for deferred tax assets was approximately $ 400.4 million and $ 367.4 million as of December 31, 2022 and 2021, respectively.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
+Added: The Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174.
+Added: Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred.
+Added: Effective for tax years beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an amortization period of 5 years for costs incurred in the US and 15 years for costs incurred in a non-US jurisdiction.
+Added: The Company incurred approximately $ 135.4 million of US research and development costs and approximately $ 38.5 million of non-US research and development costs that were capitalized during the year ended December 31, 2022.
The Coronavirus Aid, Relief, and Economic Security Act of 2020 (CARES Act) was enacted on March 27, 2020 in response to the economic fall out of the COVID-19 pandemic in the United States.
2 unchanged sentences
The Company did not participate in this deferral program.
+Added: The Inflation Reduction Act of 2022 (IRA) was enacted on August 16, 2022.
+Added: The IRA provided for a Corporate Alternative Minimum Tax (Corp AMT), applicable to tax years beginning after December 31, 2022.
+Added: The Corp AMT will impose a 15% tax on companies with adjusted financial statement income of over $1 billion for US-based organizations.
+Added: At this time, it is not anticipated that the Corp AMT will be applicable for the Company.
As of December 31, 2022, we have U.S.
6 unchanged sentences
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.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: 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, 2022 and 2021 are presented below.
5 unchanged sentences
Disallowed interest
+Added: Capitalized R&D Expenses
Deferred tax asset, excluding valuation allowance
1 unchanged sentence
Net deferred tax assets
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
There was no current or deferred income tax expense for the year ended December 31, 2022.
7 unchanged sentences
Research and development credits
+Added: Officer Compensation Limitation
Stock options
9 unchanged sentences
All of the unrecognized tax benefits, if recognized, would be offset by the valuation allowance.
+Added: TG Therapeutics, Inc.
+Added: and Subsidiaries
+Added: Notes to Consolidated Financial Statements
NOTE 9 – LICENSE AGREEMENTS
−Removed: TG-1101 (Ublituximab)
+Added: BRIUMVI (Ublituximab)
+Added: 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).
+Added: 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.
+Added: For the period ended December 31, 2022, we have incurred expenses of approximately $ 25.0 million related to the achievement of certain milestones of the LFB License Agreement, $ 12.0 million of which is recorded in accounts payable as of December 31, 2022.
+Added: These expenses are included in other research and development expenses in the accompanying consolidated statements of operations.
+Added: 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.
+Added: 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.
In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong Pharmaceutical Co.
5 unchanged sentences
In addition, upon commercialization, Ildong will make royalty payments to us on net sales of ublituximab in the sublicense territory.
−Removed: 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).
+Added: 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).
+Added: Hengrui is eligible to receive milestone payments totaling approximately $ 350 million upon and subject to the achievement of certain milestones.
+Added: 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.
+Added: In July 2020, we paid Hengrui $ 2.0 million as part of a milestone in accordance with the license agreement.
+Added: Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.
TG Therapeutics, Inc.
1 unchanged sentence
Notes to Consolidated Financial Statements
−Removed: terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab.
−Removed: For the period ended December 31, 2021, we incurred approximately $ 7.0 million in expense related to the achievement of certain milestones of the LFB License Agreement.
−Removed: These expenses are included in other research and development expenses in the accompanying consolidated statements of operations.
−Removed: As of December 31, 2021, we had approximately zero recorded in accounts payable related to the LFB License Agreement.
−Removed: LFB Group is eligible to receive payments of up to an aggregate of approximately $ 31.0 million upon our successful achievement of certain clinical development, regulatory, and sales milestones, in addition to royalty payments on net sales of ublituximab at a royalty rate that escalates from mid-single digits to high-single digits.
−Removed: 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.
−Removed: TGR-1202 (Umbralisib or UKONIQ)
+Added: anti-CD47/anti-CD19
+Added: 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).
+Added: The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies.
+Added: We serve as the primary responsible party for the development, manufacturing and commercialization of the product.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: Under the terms of the TGR-1202 License, Rhizen received a $ 4.0 million cash payment and 371,530 shares of our common stock as an upfront license fee.
+Added: As of December 31, 2022, we have incurred approximately $ 24.0 million in expense related to the achievement of certain milestones of the Umbralisib License.
+Added: 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.
−Removed: Rhizen will be eligible to receive additional approval and sales-based milestone payments in the aggregate of approximately $ 175 million payable upon approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones.
−Removed: In addition, if umbralisib is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product.
−Removed: Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib and any New Product.
+Added: Additionally, Rhizen receives tiered royalties that escalate from high single digits to low double digits on any net sales of umbralisib.
During the year ended December 31, 2022, the Company recorded $ 0.2 million related to the worldwide royalty due under the Umbralisib License in cost of product revenue based on U.S.
−Removed: sales of UKONIQ and as of December 31, 2021, $ 0.2 million in royalties were payable under the Umbralisib License.
−Removed: Rhizen shall also be eligible to participate in sublicensing revenue, if any, based on a percentage that decreases as a function of the number of patients treated in clinical trials following the exercise of the license option.
−Removed: Rhizen will retain global manufacturing rights to umbralisib, provided that they are price competitive with alternative manufacturers.
−Removed: The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or any other exclusivity right in such country, unless the agreement is earlier terminated (i) by us for any reason, or (ii) by either party due to a breach of the agreement.
−Removed: PDL1 (Cosibelimab)
+Added: sales of UKONIQ and as of December 31, 2022, approximately $ 3,000 in royalties were payable under the Umbralisib License.
+Added: As a result of the withdrawal of UKONIQ from the U.S.
+Added: market and discontinuation of all commercialization activities, we do not expect to incur any additional costs related to this license agreement.
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.
2 unchanged sentences
The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations.
−Removed: In May 2016, as part of a broader agreement with Jubilant Biosys (Jubilant), we entered into a sub-license agreement (JBET Agreement) with Checkpoint Therapeutics, Inc.
−Removed: (Checkpoint) (see Note 10), for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies.
−Removed: TG Therapeutics, Inc.
−Removed: and Subsidiaries
−Removed: Notes to Consolidated Financial Statements
−Removed: Under the terms of the agreement, we paid Checkpoint an up-front licensing fee of $ 1.0 million and will make additional payments contingent on certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $ 177 million and a single-digit royalty on net sales.
−Removed: TG will also provide funding to support certain targeted research efforts at Jubilant.
−Removed: In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co.
−Removed: (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).
−Removed: Hengrui is eligible to receive milestone payments totaling approximately $ 350 million upon and subject to the achievement of certain milestones.
−Removed: 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.
−Removed: In July 2019, we paid Hengrui the first milestone of $ 0.1 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations.
−Removed: In July 2020, we paid Hengrui $2.0 million as part of a milestone in accordance with the license agreement.
−Removed: Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.
−Removed: anti-CD47/anti-CD19
−Removed: In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (Novimmune) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701).
−Removed: The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies.
−Removed: We serve as the primary responsible party for the development, manufacturing and commercialization of the product.
−Removed: 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.
−Removed: 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.
NOTE 10 – RELATED PARTY TRANSACTIONS
3 unchanged sentences
Weiss, our Chairman and Chief Executive Officer, also serves as a director and Executive Vice Chairman, Strategic Development of FBIO.
−Removed: 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.
−Removed: 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.
−Removed: Weiss also serves as Chairman of the Board of Directors of Checkpoint.
−Removed: Please refer to Note 7 - Leases for details regarding the Office Agreement with FBIO, as well as Note 9 - License Agreements for details regarding the Collaboration Agreement and JBET Agreement with Checkpoint.
TG Therapeutics, Inc.
1 unchanged sentence
Notes to Consolidated Financial Statements
+Added: 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.
+Added: 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.
+Added: Weiss also serves as Chairman of the Board of Directors of Checkpoint.
+Added: Please refer to Note 7 - Leases for details regarding the Office Agreement with FBIO, as well as Note 9 - License Agreements for details regarding the Collaboration Agreement with Checkpoint.
NOTE 11 – COMMITMENTS AND CONTINGENCIES
4 unchanged sentences
Operating leases
+Added: Long-term debt
See Note 7 - leases for a detailed description of our lease arrangements in New York, New Jersey and North Carolina.
14 unchanged sentences
/s/ Michael S.
−Removed: Chairman and Chief Executive Officer
−Removed: Chief Financial Officer (principal financial and accounting officer)
+Added: Chairman, Chief Executive Officer and President
+Added: Chief Financial Officer, Treasurer and Corporate Secretary
/s/ Laurence N.
6 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.