UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended |
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SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from to |
Commission File Number
TG THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address including zip code of principal executive offices)
(
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Class | Trading Symbol(s) | Exchange Name |
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Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Accelerated filer ☐ |
Non-accelerated filer ☐ | Smaller reporting company |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
There were
TG THERAPEUTICS, INC.
FORM 10-Q
FOR THE QUARTER ENDED June 30, 2024
SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
Certain matters discussed in this report, including matters discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended (the Securities Act), and the Securities Exchange Act of 1934, as amended (the Exchange Act), and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these words or other comparable terminology, although not all forward-looking statements contain these identifying words.
All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about:
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our ability to obtain and maintain regulatory approvals for our product candidates, including azercabtagene zapreleucel (azer-cel), and our ability to maintain regulatory approval of BRIUMVI® (ublituximab) for the treatment of relapsing forms of multiple sclerosis (RMS) or any other future indication in the United States (U.S.), the European Union (EU) and the United Kingdom (UK); |
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our ability to adapt and expand our commercial infrastructure to successfully launch, market and sell BRIUMVI and our other product candidates; |
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our ability to maintain a reliable supply of our products that meets market demand; |
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the success of the ongoing commercialization of BRIUMVI or any future products or combinations of products, including the anticipated rate and degree of market acceptance and pricing and reimbursement; |
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the initiation, timing, progress and results of our preclinical studies and clinical trials; |
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our ability to advance drug candidates into, and successfully complete, clinical trials; |
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our ability to develop, formulate, manufacture and commercialize our product candidates; |
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our ability to establish and maintain contractual relationships and partnerships, on commercially reasonable terms, with third parties for manufacturing, distribution, marketing and supply and a range of other support functions for our clinical development and commercialization efforts; |
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the implementation of our business model and strategic plans for our business and drug candidates; |
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product and product candidates; |
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estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
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our ability to maintain and establish collaborations and enter into strategic arrangements, if desired; |
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our ability to meet any of our financial projections or guidance, including without limitation short and long-term revenue projections or guidance and changes to the assumptions underlying those projections or guidance; |
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our ability to obtain sufficient capital to fund our planned operations; |
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our financial performance and cash burn management; |
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our ability to maintain or obtain adequate product liability and other insurance coverage; |
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developments relating to our competitors and our industry; |
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the effects on our company of future regulatory developments or legislative actions, including changes in healthcare, environmental and other laws and regulations to which we are subject; |
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prevailing economic, market and business conditions; |
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our ability to retain, attract and hire key personnel; |
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fluctuations in the trading price of our common stock. |
● | our use of cash and other resources; and |
● | our ability to successfully implement our strategy. |
Our business is subject to a number of risks of which you should be aware before making an investment decision. The risks described below are a summary of the principal risks associated with an investment in us and are not the only risks we face. You should carefully consider these risks, the risk factors in Item 1A, and any other risks described in the other reports and documents that we have filed with the Securities and Exchange Commission (SEC).
Risks Related to Commercialization
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If we are unable to maintain current approval of BRIUMVI, our business will be materially harmed. |
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We cannot predict when or if we will obtain regulatory approval to commercialize our product candidates, including azer-cel in non-oncology indications. |
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We have limited experience operating as a commercial company, and, as a result, the marketing and sale of BRIUMVI for the treatment of RMS may be less successful than anticipated. |
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If BRIUMVI or any of our future product candidates (if approved) do not achieve broad market acceptance among physicians, patients, payors or the medical community, the revenues that we generate from product sales will be limited. |
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If the market opportunities for BRIUMVI and any future products for which we may receive approval, including azer-cel in non-oncology indications, are smaller than we estimate or if any approval we obtain is based on a narrower patient population or the labeling includes warnings or limitations that are not acceptable to patients or healthcare providers, our revenue will be adversely affected. |
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We face substantial competition for treatments for our target indications, including from companies with greater resources than we have, which may result in others commercializing drugs before or more successfully than we do, which could result in the reduction or elimination of our commercial opportunity. |
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If we are unable to generate sufficient revenue, we may need to raise substantial additional capital to sustain our business. |
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Product liability lawsuits could cause us to incur substantial liabilities and limit product commercialization. |
Risks Related to Drug Development and Regulatory Approval
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If we are unable to obtain or maintain regulatory approval for our product or product candidates and ultimately cannot commercialize one or more of them, or if we experience significant delays in doing so, our business will be materially harmed. |
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Our product and product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or significantly limit their commercial profile following marketing approval, if any, or result in withdrawal from the market if approved. |
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Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials. Moreover, interim, “top-line” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be impacted, as more patient data or additional endpoints are analyzed. |
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Any products or product candidates we may advance through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays, or prevent the receipt of the required approvals. |
Risks Related to Governmental Regulation of the Pharmaceutical Industry
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We are subject to extensive regulation, including new legislative and regulatory proposals, including efforts to control, set or cap pricing for approved drugs, which may increase our costs and adversely affect our ability to market our products, obtain collaborators and raise capital. |
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If we fail to comply with various healthcare laws and regulations, we may incur losses or be subject to liability. |
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If we fail to comply with regulatory requirements, any product candidate may fail to receive regulatory approval and any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties. |
Risks Related to our Dependence on Third Parties
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Our reliance on third parties for commercial and clinical supply of raw materials and our product and product candidates increases the risk that we will not have sufficient quantities of our product or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts. |
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If the third parties on which we rely to conduct our clinical trials and generate clinical, preclinical, and other data necessary to support our regulatory applications do not perform their services as required, we may not be able to obtain regulatory approval for or commercialize our product or product candidates when expected or at all. |
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Because we have in-licensed our product and product candidates from third parties, any dispute with, or non-performance by our licensors will adversely affect our ability to develop and commercialize the applicable product. |
Risks Related to Intellectual Property
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Our success depends upon our ability to obtain and protect our intellectual property, and if the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired. |
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Our patent protection could be reduced or eliminated for non-compliance with various procedural and other requirements imposed by governmental patent agencies. |
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We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms. |
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If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming to defend against such lawsuits, and an unfavorable outcome in any such lawsuit would have a material adverse effect on our business. |
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If we are unable to protect the confidentiality of our trade secrets, our business may be significantly harmed. |
Risks Related to our Financial Position and Need for Additional Capital
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We have incurred significant operating losses since our inception, and we may incur losses in the future. |
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While we do not expect to need to raise additional capital, we may need to do so. If we are unable to raise capital, if needed, we may be required to delay, limit, reduce or eliminate some of our drug development programs or commercialization efforts. |
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Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations. |
General Risk Factors
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Public health issues including an epidemic or global pandemic, including the pandemic caused by COVID-19, could have an adverse impact on our financial condition and results of operations and other aspects of our business. |
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Patients and healthcare providers have raised concerns that immunosuppressive products, like anti-CD20 antibodies and other B-cell targeted agents, may increase the risk of acquiring COVID-19 or lead to more severe complications upon infection. These concerns may impact the commercial potential for BRIUMVI and other immunosuppressive products that we have in development. |
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We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion. |
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Our ability to continue our clinical development and commercialization activities will depend on our ability to attract and maintain key management and other personnel. |
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Certain of our executive officers, directors and other stockholders own more than 5% of our outstanding common stock and may be able to influence our management and the outcome of matters submitted to shareholders for approval. |
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Certain anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition more difficult, which could limit the price investors might be willing to pay for our common stock. |
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Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit and could subject us to securities and shareholder derivative litigation. |
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Significant disruptions of information technology systems, breaches of data security or unauthorized disclosures of sensitive data could harm our business and subject us to liability or reputational damage. |
The foregoing is only a summary of some of our risks. These and other risks are discussed more fully in the section entitled “Risk Factors” in Part II, Item 1A and elsewhere in this Quarterly Report on Form 10-Q (our Risk Factors).
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| (Unaudited) | (Note 1) | ||||||
Assets | | |||||||
Current assets: | | | ||||||
Cash and cash equivalents | $ | $ | ||||||
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Accounts receivable, net | ||||||||
Inventories | ||||||||
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Total assets | $ | $ | ||||||
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Accounts payable and accrued expenses | $ | $ | ||||||
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Total current liabilities | ||||||||
Deferred revenue, non-current portion | ||||||||
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Total liabilities | ||||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, $ par value per share ( shares authorized, and shares issued, and shares outstanding at June 30, 2024 and December 31, 2023, respectively) | ||||||||
Additional paid-in capital | ||||||||
Treasury stock, at cost, shares at June 30, 2024 and December 31, 2023 | ( | ) | ( | ) | ||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total stockholders’ equity | ||||||||
Total liabilities and stockholders’ equity | $ | $ |
The accompanying notes are an integral part of the condensed consolidated financial statements.
(1) Amounts as of December 31, 2023 have been reclassified to conform to current period presentation.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
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Total other expense, net |
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Net income (loss) before taxes |
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Income tax benefit |
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Net income (loss) |
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Net income (loss) per common share: |
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Diluted |
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Weighted-average shares of common stock outstanding |
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Diluted |
The accompanying notes are an integral part of the condensed consolidated financial statements.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(in thousands, except share and per share amounts)
(Unaudited)
Additional | ||||||||||||||||||||||||||||
Common Stock | paid-in | Treasury Stock | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | capital | Shares | Amount | Deficit | Total | |||||||||||||||||||||
Balance at January 1, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
Issuance of common stock in connection with exercise of options | * | |||||||||||||||||||||||||||
Issuance of restricted stock | ( | ) | ||||||||||||||||||||||||||
Warrants issued with debt financing | — | — | ||||||||||||||||||||||||||
Forfeiture of restricted stock | ( | ) | * | — | ||||||||||||||||||||||||
Compensation in respect of restricted stock granted to employees, directors and consultants | — | — | ||||||||||||||||||||||||||
Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||
Balance at March 31, 2023 | ( | ) | ( | ) | ||||||||||||||||||||||||
Issuance of common stock in connection with exercise of options | * | |||||||||||||||||||||||||||
Issuance of restricted stock | * | * | ||||||||||||||||||||||||||
Forfeiture of restricted stock | ( | ) | * | * | ||||||||||||||||||||||||
Issuance of common stock in public offering (net of offering costs of $ million) | ||||||||||||||||||||||||||||
Compensation in respect of restricted stock granted to employees, directors and consultants | — | — | ||||||||||||||||||||||||||
Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||
Balance at June 30, 2023 | ( | ) | ( | ) |
Additional |
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paid-in |
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capital |
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Deficit |
Total |
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Balance at January 1, 2024 |
$ | $ | $ | ( |
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Issuance of common stock in connection with exercise of options |
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Issuance of restricted stock |
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Forfeiture of restricted stock |
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Compensation in respect of restricted stock granted to employees, directors and consultants |
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Net loss |
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Balance at March 31, 2024 |
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Issuance of common stock in connection with exercise of options |
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Issuance of restricted stock |
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Forfeiture of restricted stock |
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Compensation in respect of restricted stock granted to employees, directors and consultants |
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Net income |
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Balance at June 30, 2024 |
( |
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*Amount less than one thousand dollars
The accompanying notes are an integral part of the condensed consolidated financial statements.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Amortization of premium (discount) on investment securities |
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Amortization of debt issuance costs |
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Amortization of leasehold interest |
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Noncash change in lease liability and right of use asset |
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Change in fair value of notes payable |
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Changes in assets and liabilities: |
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Increase in inventory |
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Decrease (increase) in other current assets |
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Increase in accounts receivable |
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Increase in accounts payable and accrued expenses |
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Decrease in lease liabilities |
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Increase in other current liabilities |
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Increase (decrease) in deferred revenue |
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Net cash used in operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Proceeds from maturity of short-term securities |
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Investment in held-to-maturity securities |
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Investment in long-term securities |
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Net cash (used in) provided by investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Issuance of common stock, net |
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Proceeds from exercise of options |
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Proceeds from debt financings |
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Financing costs paid |
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Net cash provided by financing activities |
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NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD |
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Reconciliation to amounts on condensed consolidated balance sheets: |
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Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
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Total cash, cash equivalents and restricted cash |
$ | $ | ||||||
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Cash paid for: |
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Interest |
$ | $ | ||||||
The accompanying notes are an integral part of the condensed consolidated financial statements.
TG Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements (unaudited)
Unless the context requires otherwise, references in this report to “TG,” “Company,” “we,” “us” and “our” refer to TG Therapeutics, Inc. and our subsidiaries.
NOTE 1 ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG also received approval for BRIUMVI by the European Commission (EC) in the European Union (EU), and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK), for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG continues to actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements were prepared in accordance with U.S. generally accepted accounting principles (GAAP), for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they may not include all of the information and footnotes required by GAAP for complete financial statements. All adjustments that are, in the opinion of management, of a normal recurring nature and are necessary for a fair presentation of the condensed consolidated financial statements have been included. Nevertheless, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2023. The accompanying condensed balance sheet as of December 31, 2023 has been derived from these statements. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
In December 2018, the Company created an Australian corporation, TG Therapeutics AUS Pty Ltd. (TG AUS), as a wholly-owned subsidiary. This corporation’s functional currency, the Australian dollar, is also its reporting currency, and its financial statements are translated to U.S. dollars, the Company’s reporting currency, prior to consolidation. The activities of TG AUS result in immaterial currency translation adjustments and, thus, are included in Other Income/Expense on the Company’s condensed consolidated statement of operations. The accompanying condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and all intercompany accounts and transactions have been eliminated in consolidation.
Liquidity and Capital Resources
Historically, we have incurred operating losses; however, during the three months ended June 30, 2024 the Company experienced a net profit. Additionally, during the twelve months ended December 31, 2023, the Company experienced a net profit due to a $
Our major sources of cash have been proceeds from private placements and public offerings of equity securities, from our loan and security agreements executed with Hercules Capital, Inc. (Hercules) (see Note 7 for more information), and the upfront payment from the Commercialization Agreement (see Note 2 for more information). Substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities. During the six months ended June 30, 2024, we generated $
As of June 30, 2024, we had $
The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI, preparations for the potential commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates. We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any of our drug candidates.
Our common stock is quoted on the Nasdaq Capital Market and trades under the symbol “TGTX.”
Summary of Significant Accounting Policies
Our significant accounting policies are described in Note 1 of Notes to Consolidated Financial Statements included in our 2023 Annual Report on Form 10-K, except as updated herein or as it relates to revenue recognition, accounts receivable, inventory, cost of revenue, equity securities, and the adoption of new accounting standards during the six months ended June 30, 2024. Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s consolidated financial statements.
Financial Statement Reclassification
Certain account balances from prior periods have been reclassified in these financial statements to conform to current period classifications.
Revenue Recognition
Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five-step model that includes i) identifying the contract with a customer, ii) identifying the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the performance obligations, and v) recognizing revenue when, or as, an entity satisfies a performance obligation.
At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
Product Revenue, Net - The Company recognizes product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer. Product revenue is recorded at the net sales price, or transaction price. The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration. Variable consideration includes the following components, which are described below: chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance.
These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company’s customer account) or a liability (if the amount is expected to be settled with a cash payment). The Company’s estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. These estimates reflect the Company’s current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration received may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.
Chargebacks: Chargebacks for discounts represent the Company’s estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers and government agencies at prices lower than the list prices charged to the customers who directly purchase the product from the Company. The customers charge the Company for the difference between what the customers pay the Company for the product and the customers’ ultimate contractually committed or government required lower selling price to the qualified healthcare providers.
Government Rebates: Government rebates consist of Medicare, Tricare, and Medicaid rebates. These reserves are recorded in the same period the related revenue is recognized. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe a rebate under the Medicare Part D program.
Commercial Payer Rebates: The Company contracts with various private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of our product and contracted formulary status. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.
Trade Discounts and Allowances: The Company provides its customers with discounts that are explicitly stated in the applicable contracts and are recorded in the period the related product revenue is recognized. In addition, the Company also receives sales order management, inventory management, and data services from its customers in exchange for certain fees.
Product Returns: Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on data from similar products and other qualitative considerations, such as visibility into the inventory remaining in the distribution channel.
Subject to certain limitations, the Company’s return policy allows for eligible returns of BRIUMVI for credit under the following circumstances:
● receipt of damaged product;
● shipment errors that were a result of an error by the Company;
● expired product that is returned during the period beginning three months prior to the product’s expiration and ending six months after the expiration date;
● product subject to a recall; and
● product that the Company, at its sole discretion, has specified can be returned for credit.
As of June 30, 2024, the Company has
received any returns related to sales of BRIUMVI.
Co-Payment Assistance Programs: Co-payment assistance is provided to qualified patients with commercial insurance, whereby the Company may provide financial assistance to patients with prescription drug co-payments required by the patient's insurance provider. Reserves for co-payment assistance are recorded in the same period the related revenue is recognized.
License Agreements
The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones, and royalties on sales of products.
Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct.
Milestone payments: Contingent milestones at contract inception are estimated at the amount which is not probable of a material reversal and included in the transaction price using the most likely amount method. Milestone payments that are not within the Company's control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that may not be subject to a material reversal and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
Sales-based royalties: For arrangements that include sales-based royalties and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of when the related sales occur or when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied).
Optional Purchases: The Company’s arrangements may provide the licensee the right to make optional purchases of the licensed product. These optional purchases are accounted for as separate contracts when the licensee determines that it will make such a purchase, unless the option conveys a material right. Optional purchases are recorded as product revenue, net.
Other Revenue
Revenue is also generated from service-based fees recognized for providing regulatory support & development services to customers. Service fee revenue is recognized overtime as the services are transferred to the customer.
Deferred Product Revenue
When consideration is received, or such consideration is unconditionally due, from a customer prior to the Company completing its performance obligation to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities. Deferred revenues not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as long-term liabilities.
Accounts Receivable
In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns and chargebacks. Our contracts with customers have standard payment terms. We analyze accounts that are past due for collectability, and regularly evaluate the creditworthiness of our customers so that we can properly assess and respond to changes in their credit profiles. As of June 30, 2024, we determined an allowance for expected credit losses related to outstanding accounts receivable was currently not required based upon our review of contractual payment terms and individual customer circumstances.
Cost of Revenue
Cost of revenue consists primarily of third-party manufacturing costs, distribution, overhead and royalties owed to our licensing partner for BRIUMVI sales. Cost of revenue may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the costs of producing BRIUMVI sold to date was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. Our cost of revenue also relates to providing regulatory support & development services to customers.
Inventory
Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in-first-out method (FIFO). The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of revenue.
Prior to regulatory approval, we expense costs relating to the production of inventory as research and development expense in the period incurred. Following regulatory approval, costs to manufacture those approved products will be capitalized. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials.
Equity Securities
Our equity securities consist of common stock of Precision BioSciences, Inc. (Precision). Equity securities are recognized at their fair value in accordance with ASC 321, Investments – Equity Securities. Forward contracts to purchase equity securities that do not qualify as derivatives under ASC 815 are accounted for in accordance with ASC 321. These forward contracts are recorded at fair value at the balance sheet date. See Note 5 for further details.
Net Income (Loss) Per Common Share
Basic net income (loss) per share of our common stock is calculated by dividing net income (loss) applicable to the common stock by the weighted-average number of shares of our common stock outstanding for the period. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options, and restricted stock, which would result in the issuance of incremental shares of common stock. The impact of these items is anti-dilutive during periods of net loss. Therefore, basic and diluted net income (loss) per share were the same for all periods presented in the unaudited condensed consolidated statement of operations, except for the three months ended June 30, 2024, as the Company had net income for that period.
The following table summarizes our potentially dilutive securities at June 30, 2024 and 2023:
| As of | |||||||
| June 30, | |||||||
| 2024 | 2023 | ||||||
Unvested restricted stock | ||||||||
Options | ||||||||
Warrants | ||||||||
Shares issuable upon note conversion | ||||||||
Total |
The computation of basic and diluted EPS is as follows:
| Three months ended | Six months ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
(in thousands, except share and per share data) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
Net income (loss) | ( | ) | ( | ) | ( | ) | ||||||||||
Weighted-average common shares outstanding | ||||||||||||||||
Dilutive effect of potential common shares | ||||||||||||||||
Weighted-average common shares outstanding assuming dilution | ||||||||||||||||
| ||||||||||||||||
Net income (loss) per share - basic | ( | ) | ( | ) | ( | ) | ||||||||||
Net income (loss) per share - diluted | ( | ) | ( | ) | ( | ) |
NOTE 2 REVENUE
As discussed in Note 1, revenues are recognized under guidance within ASC 606. The following table presents our disaggregated revenue for the periods presented (in thousands):
(in thousands) | Three months ended June 30, | Six months ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
Total product revenue, net | $ | $ | $ | $ | ||||||||||||
License Revenue | ||||||||||||||||
Milestone Revenue | ||||||||||||||||
Royalty Revenue | ||||||||||||||||
Other Revenue | ||||||||||||||||
Total Revenue | $ | $ | $ | $ |
Product revenue, net
For the three and six months ended June 30, 2024, our only source of product revenue has been from U.S. sales of BRIUMVI, which we began shipping to our customers in January 2023.
As of June 30, 2024, approximately $
License Agreements
Neuraxpharm Commercialization Agreement
On July 28, 2023, the Company entered into an ex-U.S. commercialization agreement (the Commercialization Agreement) with Neuraxpharm. The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in territories outside the United States, Canada, and Mexico, which are retained by the Company, and excluding certain Asian countries of which the Company previously partnered (the Territory). In addition, the Company will perform certain development and regulatory activities for Neuraxpharm to support its obligations under the Commercialization Agreement to secure and maintain the regulatory approvals required to sell BRIUMVI in the Territory. As part of the overall arrangement, the Company has agreed to supply BRIUMVI to Neuraxpharm throughout the term of the Commercialization Agreement.
In consideration for entering into the Commercialization Agreement, the Company received a non-refundable upfront payment of $
The Company evaluated the Commercialization Agreement under ASC 606 and concluded that Neuraxpharm represents a customer in the transaction. In accordance with this guidance, the Company identified the following commitments under the arrangement: (i) the exclusive right to develop, sell, offer to sell and import the Product in the Territory (the License); (ii) certain development and regulatory activities (Development and Regulatory Activities).
The License to the Company’s intellectual property represents a distinct performance obligation, therefore, the $
The Development and Regulatory Activities performance obligation is satisfied over time because Neuraxpharm simultaneously receives and consumes the benefits provided by the Company’s performance of the services. Therefore, revenue is recognized as the activities are completed by the Company. For the three and six months ended June 30, 2024, the Company recognized Other Revenue of $
The arrangement also provides Neuraxpharm with the right to make optional purchases of BRIUMVI (the Supply of Licensed Product). These optional purchases are accounted for as a separate contract when the right to purchase BRIUMVI is exercised. The consideration for optional purchases of BRIUMVI by Neuraxpharm approximates the price that a customer in the Territory would be willing to pay for these goods.
The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. The Company evaluated the constraint on variable consideration and concluded that the milestone payments are highly dependent on factors outside of the Company’s control. Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur. Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met. All other milestones will be recognized as revenue immediately in the period the achievement of the underlying milestone is probable. In March 2024, the Company received a $
NOTE 3 INVESTMENT SECURITIES
Our short-term investments as of June 30, 2024 and December 31, 2023 are classified as held-to-maturity. Held-to-maturity investments are recorded at amortized cost.
The following tables summarize our short-term investment securities at June 30, 2024 and December 31, 2023:
| June 30, 2024 | |||||||||||||||
| Amortized | Gross | Gross | | ||||||||||||
| cost, as | unrealized | unrealized | Estimated | ||||||||||||
(in thousands) | adjusted | holding gains | holding losses | fair value | ||||||||||||
Short-term investments: | | | | | ||||||||||||
Obligations of domestic governmental agencies (maturing between and ) (held-to-maturity) | $ | $ | $ | $ | ||||||||||||
Total short-term investments | $ | $ | $ | $ |
| December 31, 2023 | |||||||||||||||
| Amortized | Gross | Gross | | ||||||||||||
| cost, as | unrealized | unrealized | Estimated | ||||||||||||
| adjusted | holding gains | holding losses | fair value | ||||||||||||
Short-term investments: | | | | | ||||||||||||
Obligations of domestic governmental agencies (maturing between and ) (held-to-maturity) | $ | $ | $ | $ | ||||||||||||
Total short-term investments | $ | $ | $ | $ |
Our long-term investments as of June 30, 2024 include shares of common stock of Precision. The fair market value of these equity securities as of June 30, 2024 was $
NOTE 4 INVENTORY
The following table presents our inventory as of June 30, 2024 (in thousands):
| June 30, 2024 | |||
Raw Materials | $ | |||
Work in Process | ||||
Finished Goods | ||||
Total Inventory | $ |
Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-process and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Inventory that is used for clinical development purposes is expensed to research and development expense when consumed.
At June 30, 2024, all our inventory was solely related to BRIUMVI, which was approved by the FDA on December 28, 2022, at which time we began to capitalize costs to manufacture BRIUMVI. Prior to the FDA approval of BRIUMVI, all costs related to the manufacturing of BRIUMVI and related material were charged to research and development expense in the period incurred.
The work in process materials consist primarily of bulk drug substance, which has a multi-year shelf life. When the bulk drug substance is manufactured into BRIUMVI finished goods, those finished goods have a shelf life of three years from the date of manufacture. Our expectation is to sell finished goods at least twelve months prior to expiration. Due to our long manufacturing lead time, it was necessary to buildup inventory in support of BRIUMVI forecasted sales, to ensure appropriate safety stock levels, and meet our commitment to supply BRIUMVI to Neuraxpharm related to the Commercialization Agreement. As a result of being in the early stages of the BRIUMVI product launch, the Company is continuing to evaluate the length of its operating cycle.
On a quarterly basis, the Company analyzes our inventory levels for excess quantities and obsolescence (expiration), taking into account factors such as historical and anticipated future sales compared to quantities on hand and the remaining shelf-life. At June 30, 2024, we determined that a reserve related to BRIUMVI inventory for excess quantities and obsolescence is
required. In addition, since FDA approval of BRIUMVI, the Company has not recorded any inventory write downs.
NOTE 5 FAIR VALUE MEASUREMENTS
We measure certain financial assets and liabilities at fair value on a recurring basis in the condensed consolidated financial statements. The fair value hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires financial assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories:
● | Level 1 quoted prices in active markets for identical assets and liabilities; |
● | Level 2 inputs other than Level 1 quoted prices that are directly or indirectly observable; and |
● | Level 3 unobservable inputs that are not corroborated by market data. |
Equity Investments and Forward Contract Liabilities
On January 7, 2024, (the Precision Effective Date) the Company and its wholly-owned subsidiary, TG Cell Therapy, Inc., (TG Cell) entered into a License Agreement (the Precision License Agreement) with Precision, pursuant to which Precision granted the Company certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize Precision’s allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel) for the treatment of autoimmune and other non-oncology diseases and conditions.
Pursuant to the Precision License Agreement, the Company made an upfront payment to Precision of $
Within 12 months following the Precision Effective Date, the Company will make a one-time payment to Precision equal to $
Upon the achievement of a clinical and regulatory milestone event (Milestone Event 1), the Company will make a one-time payment to Precision equal to $
5% Notes
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 $
The Company’s financial instruments include cash, cash equivalents consisting of money market funds, accounts receivable, accounts payable and loan payable. As of June 30, 2024 and December 31, 2023, the fair values of cash and cash equivalents, restricted cash, accounts receivable, and loan and interest payable approximate their carrying value. The carrying value of loan payable on the Company’s balance sheet is estimated to approximate its fair value as the interest rate approximates the market rate for loans with similar terms and risk characteristics.
The following tables provide the fair value measurements of applicable financial assets and liabilities as of June 30, 2024 and December 31, 2023:
Financial assets and liabilities at fair value as of June 30, 2024 | ||||||||||||||||
(in thousands) | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Equity Investments | $ | $ | $ | $ | ||||||||||||
Total Assets | $ | $ | $ | $ | ||||||||||||
Forward Contract Liabilities | $ | $ | $ | $ | ||||||||||||
5% Notes | $ | $ | $ | $ | ||||||||||||
Total Liabilities | $ | $ | $ | $ |
Financial assets and liabilities at fair value as of December 31, 2023 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
5% Notes | $ | $ | $ | $ | ||||||||||||
Total Liabilities | $ | $ | $ | $ |
Our equity investments classified as Level 1 were valued using their respective closing stock price on the Nasdaq Stock Market. We did not experience any transfers of financial instruments between the fair value hierarchy levels during the three months ended June 30, 2024. Our forward contract liabilities classified as Level 2 were valued using Precision's closing stock price on the Nasdaq Stock Market. Our Level 3 instrument amounts represent the fair value of the 5% Notes and related accrued interest.
The change in the fair value of the Level 1 assets and Level 2 and Level 3 liabilities is reported in other (income) expense in the accompanying condensed consolidated statements of operations.
NOTE 6 STOCKHOLDERS’ EQUITY
Preferred Stock
Our amended and restated certificate of incorporation authorizes the issuance of up to
Common Stock
Our amended and restated certificate of incorporation authorizes the issuance of up to
On September 2, 2022, we filed an automatic “shelf registration” statement on Form S-3 (the 2022 WKSI Shelf) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale. The 2022 WKSI Shelf was declared effective in September 2022. In connection with the 2022 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2022 ATM) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (each a 2022 Agent and collectively, the 2022 Agents), relating to the sale of shares of our common stock. Under the 2022 ATM, we will pay the 2022 Agents a commission rate of up to
During the six months ended June 30, 2023, we sold a total of
The 2022 WKSI Shelf is currently our only active shelf registration statement. We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. We may need to file additional shelf registration statements in the future to provide us with the flexibility to raise additional capital to finance our operations as needed.
Equity Incentive Plans
The TG Therapeutics, Inc. 2022 Incentive Plan (the 2022 Incentive Plan) was approved by stockholders in June 2022 with
The TG Therapeutics, Inc. Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) was approved by stockholders in June 2020. As of June 30, 2024,
Stock-based compensation expense included in the condensed consolidated statements of operations was $
During July of 2024, the Company identified an error related to the expense recognition of a single restricted stock award granted in 2021. The impact of the error was an understatement of non-cash compensation expense (SG&A) in the years ended December 31, 2022, and 2021 and a corresponding understatement of additional paid in capital (APIC). The Company has concluded the error did not result in a material misstatement of the Company’s previously issued consolidated financial statements. The cumulative impact of the error has been corrected as an immaterial correction of the December 31, 2023 condensed consolidated balance sheet by increasing accumulated deficit and APIC by approximately $
Stock Options and Restricted Stock
The following table summarizes the activity for stock options and restricted stock for the six months ended June 30, 2024:
| Stock Options | Restricted Stock | ||||||
Equity awards outstanding, beginning of year | ||||||||
Changes during the year: | ||||||||
Granted | ||||||||
Exercised or vested | ( | ) | ( | ) | ||||
Expired or Forfeited | ( | ) | ||||||
Equity awards outstanding, end of period |
As of June 30, 2024, total compensation cost related to unvested time-based awards not yet recognized and the weighted-average periods over which the awards are expected to be recognized were as follows:
(in thousands) | Stock Options | Restricted Stock | ||||||
Unrecognized compensation cost | $ | $ | ||||||
Expected weighted-average period in years of compensation cost to be recognized |
Warrants
The Company’s only outstanding warrants are the warrants issued to Hercules as part of the Loan Agreement, the Amended Loan Agreement and the First Amendment (please refer to Note 7 – Loan Payable) to purchase
NOTE 7 LOAN PAYABLE
On February 28, 2019 (the Closing Date), we entered into a term loan facility with Hercules Capital, Inc. (Hercules or Lender), which provided us with the capacity to borrow up to an aggregate principal amount of $
On December 30, 2021 (the Amended Loan Agreement Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (as amended, restated and/or modified from time to time, the Amended Loan Agreement) with Hercules Capital, Inc. The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $
On March 31, 2023 (the First Amendment Effective Date), the Company entered into a First Amendment to the Amended Loan Agreement (the First Amendment) with Hercules. The First Amendment amended the terms of the Amended Loan Agreement to, among other things, (i) issue an advance of $
The First Amendment also contains warrant coverage of
In addition, the Company is required to pay a final payment fee equal to
The Company may, at its option, prepay the Amended Term Loan in full or in part, subject to a prepayment penalty equal to (i)
The Company evaluated whether the First Amendment represented a debt modification or extinguishment of the Term Loan in accordance with ASC 470-50, Debt – Modifications and Extinguishments. As a result of the modification of terms and no repayment or retirement of the Term Loan, the Term Loan was accounted for by the Company under the modification accounting model. The Company capitalized the facility charge from the First Amendment advance to debt issuance costs and expensed third party fees in the Company’s statement of operations for the three months ended March 31, 2023.
The Company estimated the fair value of the First Amendment Warrant using the Black-Scholes model based on the following key assumptions:
Amended Term Loan | ||||
Exercise price | $ | |||
Common share price on date of issuance | $ | |||
Volatility | % | |||
Risk-free interest rate | % | |||
Expected dividend yield | % | |||
Contractual term (in years) |
The Company incurred financing expenses of $
The loan payable as of June 30, 2024 and December 31, 2023, is as follows:
| June 30, | December 31, | ||||||
(in thousands) | 2024 | 2023 | ||||||
Loan payable | $ | $ | ||||||
Add: Accreted Liability of final payment fee | ||||||||
| ||||||||
Less: unamortized debt issuance costs | ( | ) | ( | ) | ||||
| ||||||||
Less: principal payments | ||||||||
Total loan payable | ||||||||
Less: current portion | ||||||||
Loan payable non-current | $ | $ |
Refer to Note 11 for a discussion of the full repayment of this loan payable in August 2024.
NOTE 8 LEASES
In October 2014, we entered into an agreement (the Office Agreement) with Fortress Biotech, Inc. (FBIO) to occupy approximately
In October 2019, we finalized a
In October 2021, we finalized a
At January 1, 2019, we recognized a lease liability and corresponding Right-of-Use (ROU) asset of $
| Three months ended | Six months ended | ||||||||||||||
| June 30, | June 30, | June 30, | |||||||||||||
(in thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
Operating lease cost | $ | $ | $ | $ | ||||||||||||
Net lease cost | $ | $ | $ | $ |
As of June 30, 2024, the weighted-average remaining operating lease term was
| June 30, | December 31, | ||||||
(in thousands) | 2024 | 2023 | ||||||
Liabilities | | | ||||||
Lease liability current portion | $ | $ | ||||||
Lease liability non-current | ||||||||
Total lease liability | $ | $ |
As of June 30, 2024, the maturities of lease liabilities were as follows:
| Operating | |||
(in thousands) | leases | |||
Remainder of 2024 | $ | |||
2025 | ||||
2026 | ||||
2027 | ||||
2028 | ||||
After 2029 | ||||
Total lease payments | ||||
Less: interest | ( | ) | ||
Present value of lease liabilities(*) | $ |
(*) | 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 |
NOTE 9 LICENSE AGREEMENTS
BRIUMVI (Ublituximab)
In January 2012, we entered into an exclusive license agreement with LFB Biotechnologies, GTC Biotherapeutics and LFB/GTC LLC, all wholly-owned subsidiaries of LFB Group, relating to the development of ublituximab (the LFB License Agreement). Under the terms of the LFB License Agreement, we have acquired the exclusive worldwide rights (exclusive of France/Belgium) for the development and commercialization of ublituximab. As of June 30, 2024, we have incurred approximately $
LFB Group is eligible to receive royalty payments on net sales of ublituximab at a royalty rate that escalates from mid-single digits to high-single digits. The license will terminate on a country-by-country basis upon the expiration of the last licensed patent right or
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 $
We may receive up to an additional $
In July 2023, the Company entered into the Commercialization Agreement with Neuraxpharm. The Company granted Neuraxpharm the exclusive right to commercialize BRIUMVI in territories outside the United States, Canada, and Mexico, which are retained by TG, and excluding certain Asian countries previously partnered. Under the terms of the Commercialization Agreement, the Company received a one-time, non-refundable payment of $
Azer-cel
On January 7, 2024, the Company and its wholly-owned subsidiary, TG Cell Therapy, Inc., entered into the Precision License Agreement with Precision, pursuant to which Precision granted the Company certain exclusive and non-exclusive license rights to develop, manufacture, and commercialize Precision’s allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel) for the treatment of autoimmune and other non-oncology diseases and conditions.
Pursuant to the Precision License Agreement, the Company made an upfront payment to Precision of $
NOTE 10 RELATED PARTY TRANSACTIONS
In July 2015, we entered into a Shared Services Agreement (the Shared Services Agreement) with FBIO to share the cost of certain services such as facilities use, personnel costs and other overhead and administrative costs. The Shared Services Agreement requires us to pay our respective share of services utilized. In connection with the Shared Services Agreement, we incurred expenses of approximately $
Please refer to Note 8 – Leases for details regarding the Office Agreement with FBIO.
NOTE 11 SUBSEQUENT EVENTS
Term Loan Facility
On August 2, 2024, the Company entered into a term loan facility of $
The Initial Term Loan will mature on August 2, 2029 (the Term Loan Maturity Date). The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at the Company’s option, either (a) at a base rate determined by reference to the highest of (1) the prime rate published by the Wall Street Journal, (2) the federal funds effective rate plus
The Initial Term Loan is secured by a lien on substantially all of the assets of the Company and certain subsidiaries of the Company as guarantors and contains customary covenants and representations.
The events of default under the Financing Agreement are customary for financings of this type. If an event of default occurs, the Administrative Agent is entitled to take enforcement action, including acceleration of amounts due under the Financing Agreement.
On August 2, 2024, the Company repaid all outstanding principal and accrued interest and fees under the First Amendment with Hercules (such repayment, the Refinancing), which Refinancing was funded with the proceeds of the Initial Term Loan. The existing Loan Agreement with Hercules was effectively terminated and all guarantees and liens granted thereunder were released upon the consummation of the Refinancing.
Share Repurchase Program
On August 2, 2024, the Company announced that the Board of Directors (the Board) of the Company had authorized and approved a share repurchase program for up to $
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in Risk Factors. See also the Special Cautionary Notice Regarding Forward-Looking Statements set forth at the beginning of this report.
You should read the following discussion and analysis in conjunction with the unaudited condensed consolidated financial statements and the related footnotes thereto appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.
OVERVIEW
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of no