Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures. As of December 31, 2020, management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). 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, 2020, 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, 2020. 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, 2020, 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, 2020 was audited by CohnReznick LLP, our independent registered public accounting firm, as stated in their report appearing below, which expressed an unqualified opinion on the effectiveness of our internal control over financial reporting as of December 31, 2020.
Changes in Internal Control Over Financial Reporting. There were no changes in our internal control over financial reporting during the quarter ended December 31, 2020 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.
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Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
TG Therapeutics, Inc.
Opinion on Internal Control over Financial Reporting
We have audited TG Therapeutics, Inc. and subsidiaries (the “Company’s”) internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2020, based on criteria established in Internal Control—Integrated Framework (2013) issued by COSO.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets and the related consolidated statements of operations, stockholders’ equity and cash flows of the Company as of December 31, 2020 and 2019 and for each of the three years in the period ended December 31, 2020 and our report dated March 1, 2021, expressed an unqualified opinion.
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/ CohnReznick LLP
We have served as the Company’s auditor since 2003.
New York, New York
March 1, 2021
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ITEM 9B. OTHER INFORMATION.
None.
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 2021 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 2021 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 2021 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 2021 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 2021 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
F-1
Consolidated Balance Sheets as of December 31, 2020 and 2019
F-2
Consolidated Statements of Operations for the years ended December 31, 2020, 2019 and 2018
F-3
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2020, 2019 and 2018
F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2020, 2019 and 2018
F-5
Notes to Consolidated Financial Statements
F-6
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
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).
4.4
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).
4.5
Description of Securities of TG Therapeutics, Inc. #
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). †
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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
TG Therapeutics, Inc. 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). †
10.11
First Amendment to TG Therapeutics, Inc. 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. †
10.12
Second Amendment to TG Therapeutics, Inc. 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). †
10.13
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). *
10.14
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).*
10.15
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). *
10.16
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). *
10.17
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). *
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10.18
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). †
10.19
Advisory Agreement, effective January 1, 2017, between TG Therapeutics, Inc. 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).
10.20
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). *
10.21
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). *
10.22
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). *
10.23
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).
10.24
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).
10.25
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).
10.26
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). *
21.1
Subsidiaries of TG Therapeutics, Inc. #
23.1
Consent of Independent Registered Public Accounting Firm #
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 #
101
The following financial information from TG Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2020, 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.
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Table of Contents
TG Therapeutics, Inc.
Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm
F-1
Consolidated Balance Sheets as of December 31, 2020 and 2019
F-2
Consolidated Statements of Operations for the years ended December 31, 2020, 2019 and 2018
F-3
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2020, 2019 and 2018
F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2020, 2019 and 2018
F-5
Notes to Consolidated Financial Statements
F-6
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Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
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, 2020 and 2019, and the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2020, and the related notes (collectively referred to as 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, 2020 and 2019, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2020, in conformity with accounting principles generally accepted in the United States of America.
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, 2020, based on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated March 1, 2021, expressed an unqualified opinion.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s 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
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: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ CohnReznick LLP
We have served as the Company’s auditor since 2003.
New York, New York
March 1, 2021
F-1
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets as of December 31
(in thousands, except share and per share amounts)
2020
2019
Assets
Current assets:
Cash and cash equivalents
$
553,439
$
112,637
Short-term investment securities
51,987
27,798
Prepaid research and development
5,231
8,105
Other current assets
1,083
611
Total current assets
611,740
149,151
Restricted cash
1,259
1,251
Leasehold interest, net
2,051
2,129
Equipment, net
481
282
Right of use assets
9,312
9,402
Goodwill
799
799
Total assets
$
625,642
$
163,014
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$
37,014
$
30,041
Other current liabilities
18,236
48,994
Loan payable – current portion
22,179
—
Lease liability – current portion
1,669
1,616
Accrued compensation
8,456
3,798
Total current liabilities
87,554
84,449
Deferred revenue, net of current portion
610
762
Long-term debt
7,716
28,970
Lease liability – non-current
10,412
10,218
Total liabilities
106,292
124,399
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $ 0.001 par value per share ( 10,000,000 shares authorized, none issued and outstanding as of December 31, 2020 and December 31, 2019)
—
—
Common stock, $ 0.001 par value per share ( 150,000,000 shares authorized, 140,617,606 and 109,425,243 shares issued, 140,576,297 and 109,383,934 shares outstanding at December 31, 2020 and December 31, 2019, respectively)
141
109
Additional paid-in capital
1,500,040
739,956
Treasury stock, at cost, 41,309 shares at December 31, 2020 and December 31, 2019
( 234 )
( 234 )
Accumulated deficit
( 980,597 )
( 701,216 )
Total stockholders’ equity
519,350
38,615
Total liabilities and stockholders’ equity
$
625,642
$
163,014
The accompanying notes are an integral part of the consolidated financial statements.
F-2
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)
2020
2019
2018
License revenue
$
152
$
152
$
152
Costs and expenses:
Research and development:
Noncash stock expense associated with in-licensing agreements
—
100
4,000
Noncash compensation
13,962
5,811
5,598
Other research and development
151,934
148,269
149,793
Total research and development
165,896
154,180
159,391
General and administrative:
Noncash compensation
66,327
5,523
7,288
Other general and administrative
41,523
9,504
7,873
Total general and administrative
107,850
15,027
15,161
Total costs and expenses
273,746
169,207
174,552
Operating loss
( 273,594 )
( 169,055 )
( 174,400 )
Other expense (income):
Interest expense
6,329
5,287
877
Other income
( 542 )
( 1,471 )
( 1,795 )
Total other expense (income), net
5,787
3,816
( 918 )
Net loss
$
( 279,381 )
$
( 172,871 )
$
( 173,482 )
Basic and diluted net loss per common share
$
( 2.42 )
$
( 1.96 )
$
( 2.30 )
Weighted-average shares used in computing basic and diluted net loss per common share
115,333,693
88,368,844
75,466,813
The accompanying notes are an integral part of the consolidated financial statements.
F-3
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, 2018
73,181,750
$
73
$
422,017
41,309
$
( 234 )
$
( 354,863 )
$
66,993
Issuance of restricted stock
1,562,211
2
( 2 )
—
—
—
—
Forfeiture of restricted stock
( 191,196 )
*
*
—
—
—
—
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 2.0 million)
9,025,222
9
113,630
—
—
—
113,639
Compensation in respect of restricted stock granted to employees, directors and consultants
—
—
12,886
—
—
—
12,886
Shares issued in connection with in-licensing agreements
333,868
*
4,000
—
—
—
4,000
Net loss
—
—
—
—
—
( 173,482 )
( 173,482 )
Balance at December 31, 2018
83,911,855
84
552,531
41,309
( 234 )
( 528,345 )
24,036
Issuance of restricted stock
1,851,520
1
( 1 )
—
—
—
—
Warrants issued with debt financing
—
—
993
—
993
Forfeiture of restricted stock
( 116,463 )
*
*
—
—
—
—
Issuance of common stock in offerings (net of offering costs of $ 0.2 million)
10,149,783
10
77,465
—
—
—
77,475
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 2.0 million)
13,620,165
14
97,533
—
—
—
97,547
Compensation in respect of restricted stock granted to employees, directors and consultants
—
—
11,335
—
—
—
11,335
Shares issued in connection with in-licensing agreements
8,383
*
100
—
—
—
100
Net loss
—
—
—
—
—
( 172,871 )
( 172,871 )
Balance at December 31, 2019
109,425,243
109
739,956
41,309
( 234 )
( 701,216 )
38,615
Issuance of common stock in connection with exercise of options
35,814
*
146
146
Issuance of restricted stock
4,909,829
5
( 5 )
—
—
—
—
Forfeiture of restricted stock
( 128,666 )
*
—
—
—
—
—
Issuance of common stock in offerings (net of offering costs of $ 29.9 million)
17,043,000
17
462,212
—
—
—
462,229
Issuance of common stock in At-the-Market offerings (net of offering costs of $ 4.0 million)
9,332,386
10
217,442
—
—
—
217,452
Compensation in respect of restricted stock granted to employees, directors and consultants
—
—
80,289
—
—
—
80,289
Net loss
—
—
—
—
—
( 279,381 )
( 279,381 )
Balance at December 31, 2020
140,617,606
$
141
$
1,500,040
41,309
$
( 234 )
$
( 980,597 )
$
519,350
* Amount less than one thousand dollars.
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 Cash Flows for the Years Ended December 31
(in thousands)
2020
2019
2018
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$
( 279,381 )
$
( 172,871 )
$
( 173,482 )
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash stock compensation expense
80,289
11,335
12,886
Shares issued in connection with in-licensing agreement
—
100
4,000
Depreciation and amortization
158
100
88
Amortization of premium on investment securities
( 30 )
( 257 )
( 119 )
Amortization of debt issuance costs
925
772
—
Amortization of leasehold interest
216
182
135
Noncash change in lease liability and right of use asset
2,325
2,519
—
Change in fair value of notes payable
748
124
( 61 )
Changes in assets and liabilities:
Decrease (increase) in other current assets
2,263
1,395
( 1,638 )
(Increase) decrease in accrued interest receivable
( 6 )
( 11 )
14
Increase (decrease) in accounts payable and accrued expenses
11,631
( 4,795 )
10,957
(Decrease) increase in lease liabilities
( 1,988 )
( 1,548 )
—
(Decrease) increase in interest payable
( 43 )
1,491
—
(Decrease) increase in other liabilities
( 31,462 )
28,810
18,350
Decrease in deferred revenue
( 152 )
( 152 )
( 152 )
Net cash used in operating activities
( 214,507 )
( 132,806 )
( 128,925 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from maturity of short-term securities
43,250
29,250
32,500
Investment in held-to-maturity securities
( 67,403 )
( 29,837 )
( 31,230 )
Purchases of equipment
( 357 )
( 131 )
( 90 )
Net cash (used in) provided by investing activities
( 24,510 )
( 718 )
1,180
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock, net
679,680
175,021
113,639
Proceeds from exercise of options
147
—
—
Proceeds from debt financings
—
29,987
—
Financing costs paid
—
( 795 )
—
Net cash provided by financing activities
679,827
204,213
113,639
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
440,810
70,689
( 14,106 )
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF YEAR
113,888
43,199
57,305
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR
$
554,698
$
113,888
$
43,199
Reconciliation to amounts on consolidated balance sheets:
Cash and cash equivalents
$
553,439
$
112,637
$
41,958
Restricted cash
1,259
1,251
1,241
Total cash, cash equivalents and restricted cash
$
554,698
$
113,888
$
43,199
Cash paid for:
Interest
$
4,501
$
2,622
$
—
NONCASH TRANSACTIONS
Deferred financing costs
$
—
$
988
$
—
Warrants issued with debt financing
$
—
$
993
$
—
Shares issued in connection with in-licensing
$
—
$
100
$
4,000
The accompanying notes are an integral part of the consolidated financial statements.
F-5
Table of Contents
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 malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, we have received accelerated approval from the U.S. 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. Currently, we have two 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. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
LIQUIDITY AND CAPITAL RESOURCES
We have incurred operating losses since our inception, and expect to continue to incur operating losses for the foreseeable future and may never become profitable. As of December 31, 2020, we have an accumulated deficit of $ 980.6 million.
Our major sources of cash have been proceeds from the private placement and public offering of equity securities, and in 2019 from our loan and security agreement executed with Hercules Capital, Inc. (“Hercules”) (see Note 7 for more information). As of December 31, 2020 we had not yet generated revenue from drug sales of UKONIQ. UKONIQ first became commercially available in the United States in February of 2021. Even with the commercialization of UKONIQ and the future commercialization of our other drug candidates, we may not become profitable. Our ability to achieve profitability depends on our ability to generate revenue and many other factors, including our ability to obtain regulatory approval for our drug candidates; successfully complete any post-approval regulatory obligations; and successfully commercialize our drug candidates alone or in partnership. We may continue to incur substantial operating losses even if we begin to generate revenues from our drug candidates.
As of December 31, 2020, we had $ 605.4 million in cash and cash equivalents, and investment securities. We anticipate that our cash and cash equivalents, and investment securities as of December 31, 2020 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K , during which time the Company plans to continue to commercialize UKONIQ in the United States, which commenced in February 2021. 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. 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.
Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.”
F-6
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
RECENTLY ISSUED ACCOUNTING STANDARDS
In July 2018, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2018-11, Leases - Targeted Improvements (“ASU 2018-11”) as an update to ASU 2016-02, Leases (“ASU 2016-02” or “Topic 842”) issued on February 25, 2016. ASU 2016-02 is effective for public business entities for fiscal years beginning January 1, 2019. ASU 2016-02 required companies to adopt the new leases standard at the beginning of the earliest period presented in the financial statements, which is January 1, 2017, using a modified retrospective transition method where lessees must recognize lease assets and liabilities for all leases even though those leases may have expired before the effective date of January 1, 2017. Lessees must also provide the new and enhanced disclosures for each period presented, including the comparative periods.
ASU 2018-11 provides an entity with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new lease standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new lease standard will continue to be in accordance with Accounting Standards Codification (“ASC”) ASC 840, Leases (“ASC 840”). An entity that elects this additional (and optional) transition method must provide the required ASC 840 disclosures for all periods that continue to be in accordance with ASC 840. The amendments do not change the existing disclosure requirements in ASC 840.
ASU 2018-11 is effective for public business entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlier adoption permitted. The Company adopted ASU 2018-11 on January 1, 2019 using a modified retrospective method and will not restate comparative periods. We elected the package of practical expedients permitted under the transition guidance, which allows us to carry forward our historical lease classification and our assessment on whether a contract is or contains a lease. The adoption of this guidance resulted in the addition of material balances of ROU assets and lease liabilities to our consolidated balance sheets at January 1, 2019, primarily relating to our lease of office space (see Note 8). The impact to our consolidated statements of operations was not material as a result of this standard.
In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 expands the scope of FASB Topic 718, Compensation – Stock Compensation (“Topic 718”) to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should only remeasure equity-classified awards for which a measurement date has not been established through a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year of adoption. Upon transition, the entity is required to measure these nonemployee awards at fair value as of the adoption date. The entity must not remeasure assets that are completed. Disclosures required at transition include the nature of and reason for the change in accounting principle and, if applicable, quantitative information about the cumulative effect of the change on retained earnings or other components of equity.
ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted ASU 2018-07 on January 1, 2019. The adoption of ASU 2018-07 did not have a material effect on our consolidated financial statements as of January 1, 2019. The adoption of ASU 2018-07 had no impact on nonemployee performance awards as they are measured based on the outcome that is probable.
Other pronouncements issued by the FASB or other authoritative accounting standards with future effective dates are either not applicable or not significant to our consolidated financial statements.
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 accrued clinical trial expenses and stock-based compensation. Actual results could differ from those estimates. Such differences could be material to the financial statements.
F-7
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated 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, 2020 and 2019, 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 8).
INVESTMENT SECURITIES
Investment securities at both December 31, 2020 and 2019 consist of short-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
Effective January 1, 2018, the Company began recognizing revenue under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. The impact of adopting the new revenue standard was not material to our consolidated financial statements and there was no adjustment to beginning retained earnings on January 1, 2018. The core principle of this new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
● Step 1: Identify the contract with the customer
● Step 2: Identify the performance obligations in the contract
● Step 3: Determine the transaction price
● Step 4: Allocate the transaction price to the performance obligations in the contract
● Step 5: Recognize revenue when the company satisfies a performance obligation
F-8
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met:
● The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct).
● The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract).
If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct.
The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate.
RESEARCH AND DEVELOPMENT COSTS
Generally, research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered or the related services are performed, subject to an assessment of recoverability. We make estimates of certain costs incurred in relation to external clinical research organizations, or CROs, and clinical site costs. We analyze the progress of clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of the amount expensed and the related prepaid asset and accrued liability. Judgments and estimates must be made and used in determining the accrued balance and expense in any accounting period for expenses that are not explicitly defined by contractual rates and terms. We review and accrue CRO expenses and clinical trial study expenses based on work performed and rely upon estimates of those costs applicable to the stage of completion of a study. Accrued CRO costs are subject to revisions as such trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. With respect to clinical site 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 our estimate of 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, 2020 and December 31, 2019, we recorded approximately $ 5.2 million and $ 8.1 million, respectively, in prepaid research and development related to such advance agreements.
F-9
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
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.
The Coronavirus Aid, Relief, and Economic Security Act of 2020 (“CARES Act”) was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States. There are several provisions of the CARES Act that were considered in the December 31, 2020 year-end tax provision. However, the Company chose not to utilize any provisions or participate in certain programs due to lack of a benefit to the Company.
STOCK-BASED COMPENSATION
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 based on the fair values of such payments. 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.
BASIC AND DILUTED NET LOSS PER COMMON SHARE
Basic net loss per share of our common stock is calculated by dividing net loss applicable to the common stock by the weighted-average number of our common stock outstanding for the period. Diluted net loss per share of common stock is the same as basic net loss per share of common stock since potentially dilutive securities from stock options, stock warrants and convertible preferred stock would have an antidilutive effect either because we incurred a net loss during the period presented or because such potentially dilutive securities were out of the money and the Company realized net income during the period presented. The amounts of potentially dilutive securities excluded from the calculation were 11,976,276 , 8,361,739 and 6,528,932 at December 31, 2020, 2019 and 2018, respectively. During the years ended December 31, 2020, 2019 and 2018, the Company incurred a net loss; therefore, all of the securities are antidilutive and excluded from the computation of diluted loss per share.
December 31,
2020
2019
2018
Unvested restricted stock
9,285,020
5,591,786
4,595,689
Options
2,526,166
2,605,730
1,916,900
Warrants
147,058
147,058
—
Shares issuable upon note conversion
18,032
17,165
16,343
Total
11,976,276
8,361,739
6,528,932
F-10
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
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 is reviewed for impairment annually, or earlier when events arise that could indicate that an impairment exists. We test for goodwill impairment using a two-step process. The first step compares the fair value of the reporting unit with the unit’s carrying value, including goodwill. When the carrying value of the reporting unit is greater than fair value, the unit’s goodwill may be impaired, and the second step must be completed to measure the amount of the goodwill impairment charge, if any. In the second step, the implied fair value of the reporting unit’s goodwill is compared with the carrying amount of the unit’s goodwill. If the carrying amount is greater than the implied fair value, the carrying value of the goodwill must be written down to its implied fair value. We will continue to perform impairment tests annually, at December 31, and whenever events or changes in circumstances suggest that the carrying value of an asset may not be recoverable. There was no impairment to goodwill as of December 31, 2020.
NOTE 2 – CASH AND CASH EQUIVALENTS
The following tables summarize our cash and cash equivalents at December 31, 2020 and 2019:
December 31,
December 31,
(in thousands)
2020
2019
Checking and bank deposits
$
399,879
$
110,135
Money market funds
153,560
2,502
Total
$
553,439
$
112,637
F-11
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NOTE 3 – INVESTMENT SECURITIES
Our investments as of December 31, 2020 and 2019 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, 2020 and 2019:
December 31, 2020
Amortized
Gross
Gross
cost, as
unrealized
unrealized
Estimated fair
adjusted
holding gains
holding losses
value
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2021 and December 2021) (held-to-maturity)
$
51,987
$
1
$
4
$
51,984
Total short-term investment securities
$
51,987
$
1
$
4
$
51,984
December 31, 2019
Amortized
Gross
Gross
cost, as
unrealized
unrealized
Estimated fair
adjusted
holding gains
holding losses
value
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2020 and September 2020) (held-to-maturity)
$
27,798
$
28
$
—
$
27,826
Total short-term investment securities
$
27,798
$
28
$
—
$
27,826
NOTE 4 – 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.
As of December 31, 2020 and 2019, the fair values of cash and cash equivalents, restricted cash, and notes and interest payable approximate their carrying value.
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. Ariston agreed to make quarterly payments on the 5 % Notes equal to 50 % of the net product cash flow received from the exploitation or commercialization of Ariston’s product candidates, AST-726 and AST-915. We have no obligations under the 5 % Notes aside from a) 50 % of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and b) the conversion feature, discussed above.
F-12
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
The cumulative liability including accrued and unpaid interest of the 5 % Notes was approximately $ 20.3 million at December 31, 2020 and $ 19.3 million at December 31, 2019. No payments have been made on the 5 % Notes through December 31, 2020.
In December 2011, we elected the fair value option for valuing the 5 % Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments.
As of December 31, 2013, as a result of expiring intellectual property rights and other factors, it was determined that net product cash flows from AST-726 were unlikely. As we have no other obligations under the 5 % Notes aside from the net product cash flows and the conversion feature, the conversion feature was used to estimate the 5 % Notes’ fair value as of December 31, 2020 and 2019. The assumptions, assessments and projections of future revenues are subject to uncertainties, difficult to predict, and require significant judgment. The use of different assumptions, applying different judgment to inherently subjective matters and changes in future market conditions could result in significantly different estimates of fair value and the differences could be material to our consolidated financial statements.
The following tables provide the fair value measurements of applicable financial liabilities as of December 31, 2020 and 2019:
Financial liabilities at fair value as of December 31, 2020
(in thousands)
Level 1
Level 2
Level 3
Total
5 % Notes
$
—
$
—
$
938
$
938
Total
$
—
$
—
$
938
$
938
Financial liabilities at fair value as of December 31, 2019
Level 1
Level 2
Level 3
Total
5 % Notes
$
—
$
—
$
190
$
190
Total
$
—
$
—
$
190
$
190
The Level 3 amounts above 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, 2019 and 2020:
(in thousands)
Balance at January 1, 2019
$
67
Interest accrued on face value of 5 % Notes
924
Conversion of 5 % Notes
—
Change in fair value of Level 3 liabilities
( 801 )
Balance at December 31, 2019
190
Interest accrued on face value of 5 % Notes
976
Conversion of 5 % Notes
—
Change in fair value of Level 3 liabilities
( 228 )
Balance at December 31, 2020
$
938
The change in the fair value of the Level 3 liabilities is reported in other (income) expense in the accompanying consolidated statements of operations.
F-13
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NOTE 5 – STOCKHOLDERS’ EQUITY
Preferred Stock
Our amended and restated certificate of incorporation authorizes the issuance of up to 10,000,000 shares of preferred stock, $ 0.001 par value, with rights senior to those of our common stock, issuable in one or more series. Upon issuance, the Company 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").
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 150,000,000 shares of $ 0.001 par value common stock.
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. Under the 2017 S-3, we may sell up to a total of $ 300 million of securities. 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. Inc. and H.C. Wainwright & Co., LLC (each a "2017 Agent" and collectively, the "2017 Agents"), relating to the sale of shares of our common stock. 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.
During the year ended December 31, 2018, we sold a total of 9,025,222 shares of common stock under the 2017 ATM for aggregate total gross proceeds of approximately $ 115.8 million at an average selling price of $ 12.83 per share, resulting in net proceeds of approximately $ 113.7 million after deducting commissions and other transactions costs.
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.
F-14
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
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. Net proceeds from this offering, including the overallotment, were approximately $ 27.5 million after underwriting discounts and offering expenses of approximately $ 0.2 million.
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 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. 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, 2020, we sold a total of 8,528,286 shares of common stock under the 2020 ATM for aggregate total gross proceeds of approximately $ 187.5 million at an average selling price of $ 21.99 per share, resulting in net proceeds of approximately $ 184.2 million after deducting commissions and other transactions costs.
During the year ended December 31, 2020, we sold a total of 804,100 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $ 33.9 million at an average selling price of $ 42.18 per share, resulting in net proceeds of approximately $ 33.3 million after deducting commissions and other transactions costs.
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. 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. Net proceeds from this offering, including the overallotment, were approximately $ 165.1 million, net of underwriting discounts and offering expenses of approximately $ 10.8 million.
On December 17, 2020, we completed a public offering of 6,320,000 shares of our common stock (plus a 30-day underwriter overallotment option to purchase up to an additional 948,000 shares of common stock, which was exercised) at a price of $ 43.50 per share. Net proceeds from this offering, including the overallotment, were approximately $ 297.2 million after underwriting discounts and offering expenses of approximately $ 19.0 million.
The 2019 WKSI Shelf is currently our only active shelf-registration statement. We may offer any combination of the securities registered under the 2019 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We believe that the 2019 WKSI Shelf provides us with the flexibility to raise additional capital to finance our operations as needed.
Treasury Stock
As of December 31, 2020 and 2019, 41,309 shares of common stock are being held in Treasury, at a cost of approximately $ 234,000 , 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. Amended and Restated 2012 Incentive Plan (“2012 Incentive Plan”) was approved by stockholders in June 2020. Pursuant to this amendment, 8,000,000 shares were added to the 2012 Incentive Plan. As of December 31, 2020 and 2019, 2,526,166 and 2,605,730 options, respectively, were outstanding and up to an additional 4,054,913 shares may be issued under the 2012 Incentive Plan.
F-15
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Stock Options
The estimated fair value of the options granted in the year ended December 31, 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, 2020 and 2019:
Weighted-
average
Weighted-
contractual
Number of
average
term
Aggregate
shares
exercise price
(in years)
intrinsic value
Outstanding at December 31, 2018
1,916,900
—
—
$
—
Granted
815,000
$
6.50
Exercised
—
—
Forfeited
( 126,170 )
—
Expired
—
—
Outstanding at December 31, 2019
2,605,730
$
6.73
8.92
$
11,706,110
Granted
75,000
8.21
Exercised
( 35,814 )
4.10
Forfeited
( 118,750 )
10.16
Expired
—
—
Outstanding at December 31, 2020
2,526,166
$
6.99
8.10
$
115,472,832
Vested and expected to vest at December 31, 2020
2,526,166
$
6.99
8.10
$
115,472,832
Outstanding at December 31, 2020
2,526,166
$
6.99
8.10
$
115,472,832
Expected to vest at December 31, 2020
2,526,166
$
6.99
8.10
$
115,472,832
Exercisable at December 31, 2020
910,625
$
6.23
8.13
$
41,701,656
Total expense associated with the stock options was approximately $ 6.0 million, $ 3.5 million and zero during the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was approximately $ 1.7 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. As of December 31, 2020, 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 occurs. We recognized stock-based compensation expense of $ 3.8 million during the year ended December 31, 2020 for these stock options.
The fair value of the Company’s option awards were estimated using the assumptions below:
Year ended
December 31, 2020
December 31, 2019
Volatility
186.91 - 191.05
%
172.99 - 291.61
%
Expected term (in years)
5.0 - 6.25
5.0 - 6.25
Risk-free rate
0.34 - 0.54
%
1.82 - 2.49
%
Expected dividend yield
—
%
—
%
F-16
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
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, 2020, 2019 and 2018:
Weighted-average
grant date fair
Number of shares
value
Outstanding at January 1, 2018
6,321,643
$
7.17
Granted
1,562,211
13.07
Vested
( 1,596,966 )
9.38
Forfeited
( 191,196 )
8.13
Outstanding at December 31, 2018
6,095,692
8.07
Granted
1,851,520
12.95
Vested
( 738,960 )
9.08
Forfeited
( 116,463 )
7.96
Outstanding at December 31, 2019
7,091,789
7.78
Granted
4,909,829
20.34
Vested
( 1,087,918 )
8.40
Forfeited
( 128,666 )
8.70
Outstanding at December 31, 2020
10,785,034
$
13.38
Total compensation expense associated with restricted stock grants was $ 74.2 million, $ 7.8 million and $ 12.9 million during the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was approximately $ 47.4 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 . This amount does not include, as of December 31, 2020, 2,961,174 shares of restricted stock outstanding which are milestone-based and vest upon certain corporate milestones; and 1,866,250 shares of restricted stock outstanding issued to non-employees. Milestone-based noncash compensation expense will be measured and recorded if and when a milestone becomes probable.
Warrants
The Company’s only outstanding warrant is the warrant issued to Hercules as part of our debt agreement to purchase 147,058 shares of common stock with an exercise price of $ 4.08 . See Note 7 for further details. There was no expense related to warrants during the years ended December 31, 2020, 2019 and 2018.
NOTE 6 – OTHER LIABILITIES
The following is a summary of notes payable included in other current liabilities on the Company's consolidated balance sheets:
(in thousands)
December 31, 2020
December 31, 2019
Non-
Non-
Current
current
Current
current
portion,
portion,
portion,
portion,
net
net
Total
net
net
Total
Convertible 5 % Notes Payable
$
938
$
—
$
938
$
190
$
—
$
190
Totals
$
938
$
—
$
938
$
190
$
—
$
190
F-17
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Convertible 5% Notes Payable
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 obligation under the 5 % Notes aside from (a) 50 % of the net product cash flows from Ariston’s product candidates, if any, payable to noteholders; and (b) the conversion feature, discussed above. Interest accrues monthly, is added to principal on an annual basis, every March 8, and is payable at maturity, which was March 8, 2015 (see Note 4 for further details).
The cumulative liability including accrued and unpaid interest of these notes was approximately $ 20.3 million at December 31, 2020 and $ 19.3 million at December 31, 2019. No payments have been made on the 5 % Notes through December 31, 2020.
In December 2011, we elected the fair value option for valuing the 5 % Notes. The fair value option was elected in order to reflect in our financial statements the assumptions that market participants use in evaluating these financial instruments (see Note 4 for further details).
Current Liabilities
In 2018, we entered into an agreement with a contract manufacturer for the clinical and potential commercial supply of one of our product candidates. As part of this agreement, the contract manufacturer has agreed to defer payment of certain costs and expenses under the agreement in exchange for the payment of an administrative fee. To date we have incurred expenses related to this agreement of approximately $ 53.7 million as of December 31, 2020, which include service fees, raw material costs and administrative fees. We have made payments of $ 37.4 million to the contract manufacturer as of December 31, 2020. Accordingly, as of December 31, 2020 and 2019, $ 15.7 million and $ 47.2 million is included in current liabilities in the Company’s consolidated balance sheets. Of the remaining $ 15.7 million, $ 4.2 million is due in the first quarter of 2021. We will incur an administrative fee of six percent ( 6 %) per year starting from the date of invoice issuance. For the years ended December 31, 2020, 2019 and 2018, we have accrued $ 1.2 million, $ 1.2 million and zero , respectively, in administrative fees in connection with these costs, which has been included in interest expense in the Company’s consolidated statements of operations.
NOTE 7 – LONG-TERM DEBT
On February 28, 2019 (the “Closing Date”), we entered into a term loan facility of up to $ 60.0 million (“Term Loan”) with Hercules, the proceeds of which were used for research and development programs and for general corporate purposes. The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the “Loan Agreement”), which provides for up to four separate advances. The first advance of $ 30.0 million was drawn on the Closing Date. Two additional advances of $ 10.0 million may be drawn at our option but subject to certain clinical trial milestones, and the fourth advance of $ 10.0 million, available in minimum increments of $ 5.0 million, is available through December 15, 2020 subject to the approval of Hercules’ investment committee.
The Term Loan will mature on March 1, 2022 (the “Loan Maturity Date”). Each advance accrues interest at a per annum rate of interest equal to the greater of either (i) the “prime rate” as reported in The Wall Street Journal plus 4.75 %, or (ii) 10.25 %. The Term Loan provides for interest-only payments until October 1, 2020. The interest-only period may be extended to April 1, 2021 if, on or before September 30, 2020, we achieve either the third milestone or we have raised at least $ 150.0 million in unrestricted net cash proceeds from one or more equity financings, subordinated indebtedness and/or upfront proceeds from business development transactions permitted under the Loan Agreement, in each case after February 7, 2019, and prior to September 30, 2020 (“Milestone IV”). Thereafter, amortization payments will be payable monthly in eighteen installments (or, if the period requiring interest-only payments has been extended to April 1, 2021, in twelve installments) of principal and interest (subject to recalculation upon a change in prime rates). As a result of the Company having raised in excess of $ 150 million before the required timeline in the Loan Agreement, the interest-only period has been extended to April 1, 2021. At our option upon seven business days’ prior written notice to Hercules, we may prepay all or any portion greater than or equal to $ 5.0 million of the outstanding advances by paying the entire principal balance (or portion thereof), all accrued and unpaid interest, subject to a prepayment charge of 3.0 %, if such advance is prepaid in any of the first twelve months following the Closing Date; 1.5 %, if such advance is prepaid after twelve months following the Closing Date but on or prior to twenty-four months following the Closing Date; and 0 % thereafter. In addition, a final payment equal to 3.5 % of the aggregate principal amount of the loan extended by Hercules is due on the maturity date. Amounts outstanding during an event of default shall be payable on demand and accrue interest at an additional rate of 4.0 % per annum of the past due amount outstanding.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
The Term Loan is secured by a lien on substantially all of our assets, other than intellectual property, and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries. As of and through December 31, 2020, the Company has been in compliance with all covenants.
The events of default under the Loan Agreement include, without limitation, and subject to customary grace periods, (1) our failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) our breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse effect, (4) a false or misleading representation or warranty in any material respect, (5) our insolvency or bankruptcy, (6) certain attachments or judgments on the Borrower’s assets, or (7) the occurrence of any material default under certain agreements or obligations involving indebtedness in excess of $ 750,000 . If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.
The Loan Agreement also contains warrant coverage of 2 % of the total amount funded. A warrant (the “Hercules Warrant”) was issued to Hercules to purchase 147,058 shares of common stock with an exercise price of $ 4.08 . The Hercules Warrant is exercisable for seven years from the date of issuance. Hercules may exercise the Hercules Warrant either by (a) cash or check or (b) through a net issuance conversion. The shares will be registered and freely tradeable within six months of issuance. We accounted for the Hercules Warrant as an equity instrument since it was indexed to our common shares and met the criteria for classification in shareholders’ equity. The relative fair value of the Hercules Warrant on the date of issuance was approximately $ 1.0 million and was treated as debt issuance costs and as an offset to the Term Loan. This amount will be amortized to interest expense using the straight-line method, which approximates the effective interest method, over the life of the Term Loan.
The Company estimated the fair value of the Hercules Warrant using the Black-Scholes model based on the following key assumptions:
Exercise price
$
4.08
Common share price on date of issuance
$
6.80
Volatility
195.9
%
Risk-free interest rate
2.63
%
Expected dividend yield
--
%
Contractual term (in years)
7.00 years
The Company incurred financing expenses of $ 2.8 million (including the fair value of the Hercules Warrant) related to the Hercules Loan Agreement which are recorded as debt issuance costs and as an offset to long-term debt 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 are included in interest expense in the Company’s consolidated statements of operations. Amortization of debt issuance costs was $ 0.9 million and $ 0.8 million for the years ended December 31, 2020 and 2019. At December 31, 2020 and 2019, the remaining unamortized balance of debt issuance costs was approximately $ 1.1 million and $ 2.0 million, respectively.
Long-term debt as of December 31, 2020 and 2019, is as follows (in thousands):
December 31,
December 31,
(in thousands)
2020
2019
Long-term debt
$
30,000
$
30,000
End of term fee
975
975
30,975
30,975
Less: unamortized debt issuance costs
( 1,080 )
( 2,005 )
29,895
28,970
Less: current portion
( 22,179 )
—
Long-term debt non-current
$
7,716
$
28,970
F-19
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
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 $ 1.4 million under the Office Agreement. We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016. At January 1, 2019, we recognized a lease liability and corresponding 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 $ 12.1 million and $ 9.3 million, respectively, as of December 31, 2020. Our leases have remaining lease terms of 4 months to 11 years . One lease has a renewal option to extend the lease for an additional term of two years .
The initial commitment period of the 45 % rate was for a period of three ( 3 ) years. We and FBIO currently determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. As of December 31, 2020, the allocation rate is 65 % and will be evaluated again in August 2021 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. 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. We took possession of this space in October 2019, with rental payments beginning in November 2019.
The following components of lease expense are included in the Company’s consolidated statements of operations for the years ended December 31, 2020, 2019 and 2018:
December 31,
December 31,
December 31,
(in thousands)
2020
2019
2018
Operating lease cost
$
2,656
$
2,651
$
1,440
Net lease cost
$
2,656
$
2,651
$
1,440
As of December 31, 2020, the weighted-average remaining operating lease term was 7.7 years and the weighted-average discount rate for operating leases was 10.25 %. Cash paid for amounts included in the measurement of operating lease liabilities during the year ended December 31, 2020 was $ 2.0 million.
The balance sheet classification of lease liabilities was as follows:
December 31,
December 31,
(in thousands)
2020
2019
Liabilities
Lease liability current portion
$
1,669
$
1,616
Lease liability non-current
10,412
10,218
Total lease liability
$
12,081
$
11,834
F-20
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
As of December 31, 2020, the maturities of lease liabilities were as follows:
F”
Operating
(in thousands)
leases
2021
$
2,012
2022
2,035
2023
2,040
2024
1,923
2025
1,653
After 2025
9,884
Total lease payments
19,547
Less: interest
( 7,466 )
Present value of lease liabilities(*)
$
12,081
(*) As our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date and considering the term of the lease to determine the present value of lease payments. We used the incremental borrowing rate of 10.25 % on February 28, 2019, for operating leases that commenced prior to that date.
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 bases 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 $ 276.7 million and $ 186.7 million as of December 31, 2020 and 2019, respectively.
The CARES Act was enacted on March 27, 2020 in response to the economic fallout of the COVID-19 pandemic in the United States. There are several provisions of the CARES Act that were considered in the December 31, 2020 year-end tax provision as follows. Under the CARES Act, a net operating loss carryforward (“NOL”) arising in tax years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five tax years preceding the tax year of such loss. The Company has incurred taxable losses in prior years; therefore, there is no carry-back opportunity to the Company. Under the Tax Cuts and Jobs Act of 2017 (“TCJA”), deductible interest expense was limited to 30% of adjusted taxable income. The CARES Act increased the limit to 50% of adjusted taxable income for 2019 and 2020 and allowed companies to elect to use 2019 adjusted taxable income for the 2020 limitation, if it resulted in more interest expense allowed. Due to the significant amount of taxable losses, this provision did not provide any benefit to the Company as all interest expense is disallowed (except as offset by interest income), even under the 50% limitation and using 2019 adjusted taxable income. The CARES Act allows employers to defer the deposit and payment of the employer’s share of Social Security taxes during the payroll tax deferral period of March 27, 2020 through December 31, 2020. The CARES Act provides for half of the deferred payroll taxes to be paid by December 31, 2021 and the second half to be paid by December 31, 2022. The Company did not participate in this deferral program.
F-21
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
As of December 31, 2020, we have U.S. NOLs of approximately $ 956.3 million, research and development credit carryforwards (“R&D credits”) of approximately $ 27.6 million and business interest expense carryforwards of $ 7.5 million. For income tax purposes, these NOLs and R&D credits will expire in various amounts through 2037. 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 NOL 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.
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2020 and 2019 are presented below.
(in thousands)
2020
2019
Deferred tax assets:
Net operating loss carryforwards
$
223,685
$
158,177
Research and development credit
27,558
22,483
Noncash compensation
22,381
4,680
Disallowed interest
1,855
710
Other
1,224
661
Deferred tax asset, excluding valuation allowance
276,703
186,711
Less valuation allowance
( 276,703 )
( 186,711 )
Net deferred tax assets
$
—
$
—
There was no current or deferred income tax expense for the year ended December 31, 2020. Income tax expense differed from amounts computed by applying the U.S. federal income tax rate of 21 % for the years ended December 31, 2020, 2019 and 2018, to pretax loss as follows:
For the year ended December 31,
(in thousands)
2020
2019
2018
Loss before income taxes, as reported in the consolidated statements of operations
$
( 279,381 )
$
( 172,871 )
$
( 173,482 )
Computed “expected” tax benefit
$
( 58,670 )
$
( 36,303 )
$
( 36,431 )
Increase (decrease) in income taxes resulting from:
Expected benefit from state and local taxes
( 10,801 )
( 2,128 )
( 2,243 )
Research and development credits
( 5,265 )
( 7,266 )
( 4,726 )
Other
1,065
641
639
Stock options
( 1,558 )
1,292
( 473 )
Enactment of federal tax reform
( 14,763 )
—
—
Change in the balance of the valuation allowance for deferred tax assets
89,992
43,764
43,234
$
—
$
—
$
—
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 2016. However, NOLs and tax credits generated from those prior years could still be adjusted upon audit.
F-22
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
The Company would recognize interest and penalties, if any, to uncertain tax positions in income tax expense in the statement of operations. There was no accrual for interest and penalties related to uncertain tax positions for 2020. 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.
NOTE 10 – LICENSE AGREEMENTS
TG-1101 (Ublituximab)
In November 2012, we entered into an exclusive (within the territory) sublicense agreement with Ildong Pharmaceutical Co. Ltd. (“Ildong”) relating to the development and commercialization of ublituximab in South Korea and Southeast Asia. Under the terms of the sublicense agreement, Ildong has been granted a royalty bearing, exclusive right, including the right to grant sublicenses, to develop and commercialize ublituximab in South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, Vietnam, and Myanmar.
An upfront payment of $ 2.0 million, which was received in December 2012, net of $ 0.3 million of income tax withholdings, is being recognized as license revenue on a straight-line basis over the life of the agreement, which is through the expiration of the last licensed patent right or 15 years after the first commercial sale of a product in such country, unless the agreement is earlier terminated, and represents the estimated period over which we will have certain ongoing responsibilities under the sublicense agreement. We recorded license revenue of approximately $ 152,000 for each of the years ended December 31, 2020, 2019 and 2018, and, at December 31, 2020 and 2019, have deferred revenue of approximately $ 0.8 million and $ 0.9 million, respectively, associated with this $ 2 million payment (approximately $ 152,000 of which has been classified in current liabilities at December 31, 2020 and 2019).
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.
TGR-1202 (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. Prior to this, we had been jointly developing umbralisib in a 50:50 joint venture with Rhizen.
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. With respect to umbralisib, Rhizen is eligible to receive an aggregate of approximately $175 million in milestone payments, a small portion of which is attributable to the milestone paid upon the NDA filing for umbralisib and that will be payable based on the February 2021 FDA approval of umbralisib. The remainder of the milestone payments are payable on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and attaining certain sales milestones. In addition, if umbralisib is co-formulated with another drug to create a new product (a "New Product"), Rhizen will be eligible to receive similar regulatory approval and sales-based milestone payments for such New Product. Additionally, Rhizen will be entitled to tiered royalties on our future net sales of umbralisib and any New Product. In lieu of sales milestones and royalties on net sales, 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. Rhizen will retain global manufacturing rights to umbralisib, provided that they are price competitive with alternative manufacturers.
TG-1501: PDL1 (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 upon execution of the amendment we incurred an upfront fee of $ 1.0 million. We incurred expenses of approximately $ 1.1 million, $ 4.1 million and $ 0.6 million for the years ended December 31, 2020, 2019 and 2018, respectively, the majority of which relates to manufacturing expenses and milestone payments of PD-L1. The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations.
F-23
Table of Contents
TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
TG-1601: BET
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. (“Checkpoint”) (see Note 11), for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies.
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. TG will also provide funding to support certain targeted research efforts at Jubilant.
TG-1701: BTK
In January 2018, we entered into a global exclusive license agreement with Jiangsu Hengrui Medicine Co. (“Hengrui”), to acquire worldwide intellectual property rights, excluding Asia but including Japan, and for the research, development, manufacturing, and commercialization of products containing or comprising of any of Hengrui’s Bruton’s Tyrosine Kinase inhibitors containing the compounds of either TG-1701 (SHR1459 or EBI1459) or TG1702 (SHR1266 or EBI1266). Pursuant to the agreement, in April 2018, we paid Hengrui an upfront fee of $ 1.0 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations. In addition, 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. Hengrui is eligible to receive milestone payments totaling approximately $ 350 million upon and subject to the achievement of certain milestones. Various provisions allow for payments in conjunction with the agreement to be made in cash or our common stock, while others limit the form of payment. Royalty payments in the low double digits are due on net sales of licensed products and revenue from sublicenses.
TG-1801: anti-CD47/anti-CD19
In June 2018, we entered into a Joint Venture and License Option Agreement with Novimmune SA (“Novimmune”) to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies. We serve as the primary responsible party for the development, manufacturing and commercialization of the product. Pursuant to the agreement, in June 2018 we paid Novimmune an upfront payment of $ 3.0 million in our common stock recorded to noncash stock expense associated with in-licensing agreements in our consolidated statement of operations. Further milestone payments will be paid based on early clinical development, and the Company will be responsible for the costs of clinical development of the product through the end of the Phase 2 clinical trials, after which the Company and Novimmune will be jointly responsible for all development and commercialization costs. The Company and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for the Company to license the rights to TG-1801, in which case Novimmune is eligible to receive additional milestone payments totaling approximately $ 185 million as well as tiered royalties on net sales in the high single to low double digits upon and subject to the achievement of certain milestones.
NOTE 11 – RELATED PARTY TRANSACTIONS
LFB Biotechnologies
On January 30, 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”). In connection with the LFB License Agreement, LFB Group was issued 5,000,000 shares of common stock, and a warrant to purchase 2,500,000 shares of common stock at a purchase price of $ 0.001 per share.
Under the terms of the LFB License Agreement, we utilize LFB Group for certain development and manufacturing services. As of December 31, 2020 we accrued approximately $ 6.0 million in expense 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, 2020, we had approximately zero recorded in accounts payable related to the LFB License Agreement.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Other Parties
In October 2014, we entered into the Office Agreement with 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 $ 1.1 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 of $ 9.3 million, with a corresponding ROU asset of $ 7.7 million 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. Mr. Weiss, our Executive Chairman and CEO, is also Executive Vice Chairman of FBIO.
Under the Office Agreement, we agreed to pay FBIO our portion of the build-out costs, which have been allocated to us at the 45 % rate mentioned above. The allocated build-out costs have been recorded in Leasehold Interest, net on the Company's consolidated balance sheets and will be amortized over the 15-year term of the Office Agreement. The initial commitment period of the 45 % rate was for a period of three ( 3 ) years. We and FBIO currently determine actual office space utilization annually and if our utilization differs from the amount we have been billed, we will either receive credits or be assessed incremental utilization charges. As of December 31, 2020, the allocation rate is 65 % and will be evaluated again in August 2021 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. Additional collateral of $ 0.6 million was pledged in April 2018 to increase the letter of credit for the office space.
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 $ 0.8 million, $ 0.9 million and $ 1.6 million for shared services for the years ended December 31, 2020, 2019 and 2018, respectively, primarily related to shared personnel.
In May 2016, as part of a broader agreement with Jubilant, we entered into a sublicense agreement with Checkpoint, a subsidiary of FBIO, for the development and commercialization of Jubilant’s novel BET inhibitor program in the field of hematological malignancies. We paid Checkpoint an up-front licensing fee of $ 1.0 million in July 2016 and incurred expenses of $ 0.2 million in March 2017 for the first milestone achievement as part of the JBET Agreement which is recorded in other research and development in the accompanying consolidated statement of operations.
In March 2015, we entered into the 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 upon execution of the amendment we incurred an upfront fee of $ 1.0 million. We incurred expenses of approximately $ 1.1 million, $ 4.1 million and $ 0.6 million for the years ended December 31, 2020, 2019 and 2018, respectively, the majority of which relates to manufacturing expenses and milestone expenses PD-L1. The relevant expenses are recorded in other research and development in the accompanying consolidated statements of operations.
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TG Therapeutics, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
NOTE 12 – COMMITMENTS AND CONTINGENCIES
As of December 31, 2020, we have known contractual obligations; commitments and contingencies of $ 65.2 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
$
19,548
$
2,012
$
4,075
$
3,577
$
9,884
Long-term debt
30,000
22,179
7,821
—
—
Contract manufacturer
15,669
15,669
—
—
—
Total
$
65,217
$
39,860
$
11,896
$
3,577
$
9,884
Contract Manufacturer
See Note 6 for a detailed description of our current liabilities. Future minimum contractual commitments as of December 31, 2020 total approximately $ 15.7 million and are due in 2021.
Leases
See Note 8 for a detailed description of our lease arrangements in New York and New Jersey. Total rental expense was approximately $ 2.7 million, $ 2.7 million and $ 1.4 million for the years ended December 31, 2020, 2019, and 2018, respectively.
Future minimum lease commitments as of December 31, 2020, in the aggregate total approximately $ 19.5 million through December 31, 2031. The preceding table shows future minimum lease commitments, which include our office leases in New York, New Jersey, North Carolina and Tennessee by year as of December 31, 2020.
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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: March 1, 2021
By:
/s/ Michael S. Weiss
Michael S. Weiss
Executive Chairman,
Chief Executive Officer and President
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Table of Contents
POWER OF ATTORNEY
KNOW ALL MEN 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 March 1, 2021, and in the capacities indicated:
Signatures
Title
/s/ Michael S. Weiss
Michael S. Weiss
Executive Chairman, Chief Executive Officer and President (principal executive officer)
/s/ Sean A. Power
Sean A. Power
Chief Financial Officer (principal financial and accounting officer)
/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/ William J. Kennedy
William J. Kennedy
Director
/s/ Sagar Lonial
Sagar Lonial
Director
98
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.