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TG Therapeutics (NASDAQ: TGTX) lifts 2026 BRIUMVI revenue outlook

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8-K

Rhea-AI Filing Summary

TG Therapeutics reported higher Q2 2026 revenue led by BRIUMVI. Total revenue reached $240.3 million, up from $141.1 million a year earlier. Product revenue was $235.8 million, driven by BRIUMVI U.S. net product revenue of $227.7 million, approximately 64% higher than the prior-year quarter, plus $8.1 million of BRIUMVI sales to ex-U.S. partner Neuraxpharm and $4.5 million of license, milestone, royalty and other revenue.

Operating income was $21.7 million, but net income declined to $7.8 million from $28.2 million as cost of revenue rose to $41.2 million, R&D expense increased to $95.3 million (including $54.6 million for subcutaneous BRIUMVI manufacturing and secondary manufacturer costs), and SG&A expense grew to $82.1 million, alongside higher interest expense of $16.6 million.

Cash, cash equivalents and investment securities were $612.3 million at June 30, 2026, and the company expects this plus projected BRIUMVI revenue to fund its current operating plan. Full‑year 2026 guidance was raised to approximately $950 million in total global revenue and $890–$905 million in BRIUMVI U.S. net product revenue, with targeted operating expenses of $350–$400 million excluding non‑cash compensation and about $100 million for subcutaneous BRIUMVI manufacturing and secondary manufacturer start‑up costs. Management also highlighted positive Phase 3 ENHANCE results and progress in subcutaneous BRIUMVI, myasthenia gravis, schizophrenia and the azer‑cel platform.

Positive

  • Total revenue for Q2 2026 rose to $240.3 million, up from $141.1 million in Q2 2025, reflecting strong BRIUMVI-driven growth.
  • Management raised full-year 2026 total global revenue guidance to approximately $950 million and BRIUMVI U.S. net product revenue guidance to approximately $890–$905 million.
  • BRIUMVI U.S. net product revenue reached $227.7 million in Q2 2026, representing approximately a 64% increase over the same period in 2025.

Negative

  • Despite higher sales, Q2 2026 net income declined to $7.8 million from $28.2 million a year earlier, as R&D, SG&A and interest expenses increased.
  • Total research and development expense increased to $95.3 million in Q2 2026 from $31.8 million in Q2 2025, including $54.6 million tied to subcutaneous BRIUMVI manufacturing and secondary manufacturer costs.
  • Quarterly interest expense rose to $16.6 million from $6.7 million in Q2 2025, contributing to lower net income.

Filing Explained

At June 30, total equity was $604,083 thousand versus $648,020 thousand at December 31; the release was furnished rather than filed.

As a Form 8-K, this filing reports a specified material event: TG Therapeutics furnished its August 3, 2026 release reporting second-quarter and six-month results and updating 2026 guidance.

The release is furnished under Item 2.02 and states that the information is not deemed filed for Section 18 purposes or incorporated by reference except by specific reference. The filing therefore records an operating update and does not itself establish a new issuance, offering, or other ownership transaction.

The release distinguishes historical second-quarter results from forward-looking guidance and anticipated development milestones. The stated revenue targets and trial dates remain targets or expected dates rather than completed outcomes.

The balance sheet reports total equity of $604,083 thousand at June 30, 2026, compared with $648,020 thousand at December 31, 2025; this adds balance-sheet context not reflected in the operating update alone.

The named resolution points are the full ENHANCE results and topline Phase 3 subcutaneous BRIUMVI data expected at year-end 2026 or early 2027.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Total revenue $240.335 million Three months ended June 30, 2026; compared with $141.148 million in Q2 2025
Product revenue, net $235.794 million Q2 2026, primarily BRIUMVI sales in the United States
BRIUMVI U.S. net product revenue $227.7 million Second quarter 2026, approximately 64% increase over same period in 2025
Net income $7.781 million Three months ended June 30, 2026; down from $28.187 million in Q2 2025
Cash, cash equivalents and investment securities $612.253 million Balance as of June 30, 2026
2026 total global revenue guidance $950 million Full-year 2026 target total global revenue
2026 BRIUMVI U.S. revenue guidance $890–$905 million Full-year 2026 target BRIUMVI U.S. net product revenue range
Research and development expense $95.337 million Total R&D expense for Q2 2026, including subcutaneous BRIUMVI manufacturing costs
glycoengineering medical
"Removal of these sugar molecules, a process called glycoengineering, allows for efficient"
Glycoengineering is the deliberate modification of sugar chains (glycans) attached to proteins or cells to change how those molecules behave in the body. Like tuning the trim on a car to alter fuel efficiency or comfort, changing glycans can affect a drug’s stability, how long it circulates, immune recognition and manufacturing consistency, which in turn influences clinical performance, regulatory review and commercial value.
Progressive Multifocal Leukoencephalopathy (PML) medical
"Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain"
bioavailability medical
"Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV"
Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.
B-cell depleting therapy medical
"As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed"
A B-cell depleting therapy is a treatment that reduces the number or activity of B cells, a type of immune cell that can produce antibodies. Think of it like temporarily sending home workers who are misbuilding parts of the immune system so inflammation or certain cancers calm down. Investors care because these therapies drive clinical trial results, regulatory approvals, long-term sales and safety profiles — all of which affect a drug maker’s revenue, costs and stock outlook.
loss on extinguishment of debt financial
"Loss on extinguishment of debt was $9,153 for the six months ended June 30, 2026"
Loss on extinguishment of debt is the accounting hit a company records when it retires or restructures a loan or bond for an amount that exceeds the debt’s recorded value—like paying more than the remaining balance to settle a loan early. It matters to investors because it reduces reported profit and can use cash, but may also cut future interest costs or signal financial stress; understanding it helps assess earnings quality and balance-sheet strength.
Total revenue Q2 2026 $240.335 million up from $141.148 million in Q2 2025
Net income Q2 2026 $7.781 million down from $28.187 million in Q2 2025
Diluted EPS Q2 2026 $0.05 down from $0.17 in Q2 2025
Cash, cash equivalents and investment securities $612.253 million up from $199.511 million at December 31, 2025
Guidance

Company targets full-year 2026 total global revenue of approximately $950 million and BRIUMVI U.S. net product revenue of approximately $890–$905 million, with operating expenses of approximately $350–$400 million excluding non-cash compensation plus about $100 million of subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

How much revenue did TG Therapeutics (TGTX) report for Q2 2026?

TG Therapeutics reported Q2 2026 total revenue of $240.3 million, up from $141.1 million in Q2 2025. Product revenue was $235.8 million and license, milestone, royalty and other revenue contributed $4.5 million, showing substantial year-over-year growth driven mainly by BRIUMVI.

What were BRIUMVI U.S. net product sales for TG Therapeutics (TGTX) in Q2 2026?

BRIUMVI U.S. net product revenue was $227.7 million in Q2 2026, an approximately 64% increase versus the prior-year quarter. The company also recorded $8.1 million of BRIUMVI sales to ex-U.S. partner Neuraxpharm, further contributing to overall product revenue.

How profitable was TG Therapeutics (TGTX) in Q2 2026?

TG Therapeutics generated Q2 2026 net income of $7.8 million, down from $28.2 million in Q2 2025. Diluted EPS was $0.05 versus $0.17 a year earlier, as higher cost of revenue, R&D, SG&A and interest expense offset the strong revenue increase.

What 2026 revenue guidance did TG Therapeutics (TGTX) provide?

The company targets full-year 2026 total global revenue of about $950 million and BRIUMVI U.S. net product revenue of approximately $890–$905 million. It also guides to operating expenses of $350–$400 million excluding non-cash compensation plus about $100 million for subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up costs.

What is TG Therapeutics’ (TGTX) cash position after Q2 2026?

As of June 30, 2026, TG Therapeutics held $612.3 million in cash, cash equivalents and investment securities. Management stated it expects this balance, together with projected BRIUMVI revenue, to be sufficient to fund the business under its current operating plan.

What pipeline milestones did TG Therapeutics (TGTX) highlight for 2026?

The company plans to present full Phase 3 ENHANCE results, share preliminary Phase 1 azer-cel data in progressive MS, and announce topline Phase 3 data for subcutaneous BRIUMVI around year-end 2026 or early 2027, while advancing programs in myasthenia gravis and schizophrenia.
false 0001001316 0001001316 2026-08-03 2026-08-03
 ​​


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 

 
FORM 8-K
    

 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of report (Date of earliest event reported): August 3, 2026
 
TG Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
 
Delaware
001-32639
36-3898269
(State or Other Jurisdiction
(Commission File Number)
(IRS Employer Identification No.)
of Incorporation)
 ​
3020 Carrington Mill Blvd, Suite 475
Morrisville, North Carolina 27560
(Address of Principal Executive Offices)
 
(212) 554-4484
(Registrant’s telephone number, including area code)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities filed pursuant to Section 12(b) of the Act:
 
Title of Class
Trading Symbol(s)
Exchange Name
Common Stock
TGTX
Nasdaq Capital Market
 ​
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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. ☐
 

 
 
Item 2.02. Results of Operations and Financial Condition.
 ​
On August 3, 2026, the Company issued a press release announcing results of operations for the three and six months ended June 30, 2026. A copy of such press release is being furnished as Exhibit 99.1.
 
In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.
 
Description
     
99.1
 
Press release issued by TG Therapeutics, Inc., dated August 3, 2026.
     
104
 
The cover page from this Current Report on Form 8-K formatted in Inline XBRL.
 ​
 

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
TG Therapeutics, Inc.
(Registrant)
Date: August 3, 2026
By:
/s/ Sean A. Power
Sean A. Power
Chief Financial Officer
 ​
 

Exhibit 99.1

 

TG Therapeutics Reports Second Quarter 2026 Financial Results and Raises BRIUMVI® Revenue Guidance

 

Second quarter 2026 total global revenue of approximately $240 million, including BRIUMVI U.S. net product revenue of approximately $228 million

 

Raises full year 2026 total global revenue target to approximately $950 million and raises full year 2026 BRIUMVI U.S. net product revenue target to approximately $890 - 905 million

 

Conference call to be held today, Monday, August 3, 2026, at 8:30 AM ET

 

New York, NY, (August 3, 2026) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the second quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance.

 

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “The second quarter of 2026 was another strong quarter for TG Therapeutics. BRIUMVI delivered another outstanding commercial quarter, exceeding our expectations once again and putting us on track to exit 2026 at an approximately $1 billion annualized U.S. BRIUMVI revenue run rate.

 

Mr. Weiss continued, “Beyond our commercial performance, we continued to expand the long-term opportunity for BRIUMVI with positive Phase 3 ENHANCE results supporting a simplified initiation regimen, encouraging progress in our subcutaneous BRIUMVI program, advancement into myasthenia gravis and schizophrenia, and continued momentum across our azer-cel cell therapy platform. As BRIUMVI continues to grow, it is becoming the foundation of a broader company focused on advancing innovative therapies for immune-mediated diseases. The progress we made this quarter reinforces our confidence in our strategy and our ability to create long-term value for both patients and shareholders.”

 

Recent Highlights & Developments

 

BRIUMVI® (ublituximab-xiiy) Commercialization

 

BRIUMVI U.S. net product revenue of $227.7 million for the second quarter 2026, representing approximately a 64% increase over the same period last year

 

Total global revenue of $240.3 million for the second quarter 2026

 

Subcutaneous BRIUMVI

 

Announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab (the active agent in BRIUMVI) as compared to IV BRIUMVI

 

Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial

 

PK modeling and simulation informed by the Phase 1 bioavailability data support the quarterly subcutaneous dosing regimen that is being evaluated in the fully enrolled Phase 3 trial

 

Top-line Phase 3 data is expected year-end 2026 or early 2027

 

Positive Topline Phase 3 ENHANCE Data

 

Announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI in adults with RMS

 

The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion.

 

BRIUMVI in Myasthenia Gravis

 

Announced positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis (MG)

 

Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG

 

 

 

BRIUMVI in Schizophrenia

 

Initiated a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia

 

2026 Financial Guidance Update

 

Raises full year 2026 target total global revenue to approximately $950 million

 

Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $890 - $905 million

 

Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 - $400 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs

 

2026 Remaining Development Pipeline Anticipated Milestones

 

Present full results from the Phase 3 ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI

 

Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026

 

Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027

 

 

Financial Results for Second Quarter 2026

 

 

Product Revenue, net: Product revenue, net was $235.8 million and $437.1 million for the three and six months ended June 30, 2026, respectively, compared to $138.8 million and $258.5 million for the three and six months ended June 30, 2025, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $227.7 million and $422.5 million during the three and six months ended June 30, 2026. Also included in product revenue, net for the three and six months ended June 30, 2026 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $8.1 million and $14.6 million, respectively.

     
 

License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $4.5 million and $8.1 million for the three and six months ended June 30, 2026, respectively, compared to approximately $2.3 million and $3.5 million for the three and six months ended June 30, 2025. License, milestone, royalty and other revenue for the three and six months ended June 30, 2026 is predominantly comprised of $3.6 million and $6.3 million, respectively, of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm, and $0.9 million and $1.8 million, respectively, of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement.

     
 

R&D Expenses: Total research and development (R&D) expense was approximately $95.3 million and $143.7 million for the three and six months ended June 30, 2026, compared to $31.8 million and $78.1 million for the three and six months ended June 30, 2025. During the three and six months ended June 30, 2026 we incurred approximately $54.6 million and $58.8 million, respectively related to subcutaneous manufacturing and secondary manufacturer expenses. The period over period increase in R&D was also attributable to higher clinical trial-related expenses associated with our development pipeline during the period.

     
 

SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $82.1 million and $170.3 million for the three and six months ended June 30, 2026, compared to $55.6 million and $105.9 million for the three and six months ended June 30, 2025. The increase in selling, general and administrative costs during the three and six months ended June 30, 2026 was primarily due to an increase in marketing and media spend, and personnel costs associated with the commercialization of BRIUMVI.

     
 

Net income: Net income was $7.8 million and $27.6 million for the three and six months ended June 30, 2026, respectively, compared to net income of $28.2 million and $33.2 million for the three and six months ended June 30, 2025.

     
 

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $612.3 million as of June 30, 2026. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.

 

 

 

CONFERENCE CALL INFORMATION
The Company will host a conference call today, August 3, 2026, at 8:30 AM ET, to discuss the Company’s financial results from second quarter of 2026.

 

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for a period of 30 days after the call.

 

 

ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

 

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

 

A list of authorized specialty distributors can be found at www.briumvi.com.

 

 

IMPORTANT SAFETY INFORMATION

 

Contraindications: BRIUMVI is contraindicated in patients with:

 

Active Hepatitis B Virus infection

 

A history of life-threatening infusion reaction to BRIUMVI

 

WARNINGS AND PRECAUTIONS

 

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

 

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

 

 

 

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

 

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

 

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

 

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

 

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

 

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

 

If PML is confirmed, treatment with BRIUMVI should be discontinued.

 

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

 

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

 

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

 

 

 

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

 

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

 

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

 

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

 

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

 

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

 

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

 

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1

 

ABOUT TG THERAPEUTICS

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.

 

BRIUMVI® is a registered trademark of TG Therapeutics, Inc.

 

 

 

Cautionary Statement

 

This press release contains forward-looking statements that involve a number of risks and uncertainties. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy, and objectives for future operations may constitute forward-looking statements. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

 

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.

 

Such forward looking statements include but are not limited to statements regarding our plans, business strategies and operations related to the commercialization of BRIUMVI® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; our ability to execute our share repurchase program; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI; expectations and timing for our ENHANCE Phase 3 pivotal program to evaluate a consolidated day 1 and day 15 dosing regimen for IV BRIUMVI; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG.

 

Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) completing a pivotal program for subcutaneous ublituximab, (ii) completing a pivotal program based on data from the ENHANCE trial to consolidate day 1 and day 15 dosing, (iii) enrolling patients into a trial evaluating BRIUMVI in MG or schizophrenia, or (iv) enrolling patients into a trial evaluating azer-cel; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the risk that the subcutaneous Phase 3 program will not be successful or if successful still will not be approved by the FDA or achieve commercial acceptance; the risk that, if subcutaneous BRIUMVI is approved, the anticipated expansion of the addressable market will not be realized; the risk that the ENHANCE Phase 3 trial will not be successful or if successful will not be approved by the FDA or achieve commercial acceptance; the risk that we will not move forward with the development of BRIUMVI in MG or schizophrenia and azer-cel in progressive MS following preliminary studies; the uncertainties generally inherent in research and development and early stage exploratory programs; the risk that the collaboration with Christina Applegate is not able to be implemented or does not go as planned for regulatory or other reasons; the risk that the www.nextinms.com platform does not gain traction or ceases to exist; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the SEC.

 

 

 

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


CONTACT:

 

Investor Relations

Email: ir@tgtxinc.com

Telephone: 1.877.575.TGTX (8489), Option 4

 

Media Relations:

Email: media@tgtxinc.com

Telephone: 1.877.575.TGTX (8489), Option 6

 

1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236.


 

 

TG Therapeutics, Inc.

Selected Condensed Consolidated Financial Data

 

Statements of Operations Information (in thousands, except share and per share amounts; unaudited):

 

   

Three months ended

   

Six months ended

 
   

June 30,

   

June 30,

 
   

2026

   

2025

   

2026

   

2025

 

Revenue:

                               

Product revenue, net

  $ 235,794     $ 138,843     $ 437,102     $ 258,498  

License, milestone, royalty and other revenue

    4,541       2,305       8,151       3,506  

Total revenue

  $ 240,335     $ 141,148     $ 445,253     $ 262,004  
                                 

Costs and expenses:

                               

Cost of revenue

    41,194       18,938       74,704       34,479  

Research and development:

                               

Stock-based compensation

    8,070       4,318       12,945       7,649  

Other research and development

    87,267       27,464       130,788       70,495  

Total research and development

    95,337       31,782       143,733       78,144  
                                 

Selling, general and administrative:

                               

Stock-based compensation

    19,805       12,044       34,880       23,684  

Other selling, general and administrative

    62,325       43,541       135,467       82,232  

Total selling, general and administrative

    82,130       55,585       170,347       105,916  
                                 

Total costs and expenses

    218,661       106,305       388,784       218,539  
                                 

Operating income

    21,674       34,843       56,469       43,465  
                                 

Other expense (income):

                               

Interest expense

    16,572       6,716       24,238       13,473  

Loss on extinguishment of debt

                9,153        

Other income

    (5,132 )     (2,793 )     (7,519 )     (6,396 )

Total other expense

    11,440       3,923       25,872       7,077  
                                 

Net income before taxes

  $ 10,234     $ 30,920     $ 30,597     $ 36,388  

Income tax expense

    (2,453 )     (2,733 )     (3,039 )     (3,141 )

Net income

  $ 7,781     $ 28,187     $ 27,558     $ 33,247  
                                 

Net income per common share:

                               

Basic

  $ 0.05     $ 0.19     $ 0.19     $ 0.23  

Diluted

  $ 0.05     $ 0.17     $ 0.17     $ 0.20  
                                 

Weighted-average shares of common stock outstanding

                               

Basic

    141,770,283       146,739,833       143,097,453       146,708,980  

Diluted

    157,281,850       162,559,404       158,664,407       162,528,551  

 

 

 

 

Condensed Balance Sheet Information (in thousands):

 

   

June 30, 2026

(Unaudited)

   

December 31,

2025*

 

Cash, cash equivalents and investment securities

    612,253       199,511  

Total assets

    1,639,629       1,063,253  

Total equity

    604,083       648,020  

 

 

* Condensed from audited financial statements

 

 

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