TG Therapeutics Reports Third Quarter 2026 Financial Results and Raises Full-Year Revenue Guidance
Higher revenue targets accompany increased development and commercial expenses, while quarterly share repurchases totaled approximately $100 million.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Raises full-year 2026 total global revenue guidance to approximately
Raises full-year 2026 BRIUMVI
Third-quarter 2026 total global revenue of approximately
MSToronto2026 presentations highlight seven-year BRIUMVI efficacy and safety follow-up, positive ENHANCE results supporting BRIUMVI single-infusion initiation, and progress toward quarterly self-administered subcutaneous treatment
Conference call to be held today, Monday, November 9, 2026, at 8:30 AM ET
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “With solid third-quarter performance and a strong fourth quarter anticipated, we are on track to exceed
Mr. Weiss continued, “Looking ahead, we see a series of important catalysts over the next 18 to 24 months, including pivotal Phase 3 subcutaneous BRIUMVI results expected around year-end or early 2027, a potential launch of simplified IV initiation in mid-2027, additional clinical data from our expanding pipeline, and a potential subcutaneous BRIUMVI launch in 2028. Our increased full-year revenue guidance reflects the continued strength of our commercial business, while the approximately
Recent Highlights & Developments
BRIUMVI® (ublituximab-xiiy) Commercialization
-
BRIUMVI
U.S . net product revenue of$232.6 million 52% increase over the same period last year -
Total global revenue of
$259.9 million
Clinical Data Highlights from MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting
- Phase 3 ENHANCE Trial: Positive Phase 3 results demonstrated bioequivalent drug exposure between the currently approved two-infusion BRIUMVI initiation regimen and a consolidated single 600mg initiation infusion. Infusion-related reactions were comparable between regimens, with no Grade 3 or higher reactions observed, supporting the potential for a simplified treatment initiation schedule.
-
Phase 1 Subcutaneous BRIUMVI (ublituximab) Trial: Positive Phase 1 data demonstrated mean bioavailability greater than
60% relative to IV administration, with pharmacokinetic modeling supporting the quarterly dosing regimen being evaluated in the fully enrolled Phase 3 trial. Top-line Phase 3 data are expected by year-end 2026 or early 2027. -
Seven-Year Follow-up Data from the ULTIMATE I & II Phase 3 Trials: BRIUMVI demonstrated sustained efficacy with an annualized relapse rate (ARR) of 0.018 in the seventh year of treatment and
88.3% of continuously treated patients remaining free from 24-week confirmed disability progression. Patients receiving continuous BRIUMVI treatment experienced lower rates of disability progression than those who switched from teriflunomide, with a consistent long-term safety profile. -
Phase 4 ENABLE Real-World Study: Updated data from 1,076 participants,
30% of whom switched from prior CD20 therapy, showed that99.2% remained relapse-free during BRIUMVI treatment, with an ARR of 0.014. First-dose infusion-related reactions occurred in18.8% of participants, and median subsequent infusion times of 63 minutes supported the one-hour infusion experience in clinical practice. -
Phase 1 Azer-cel in Progressive MS Trial: Initial data demonstrated an encouraging safety profile in 26 participants, with no dose-limiting or high-grade CAR T-associated toxicities observed. Despite prior disease progression,
89% of evaluable participants had stable or improved disability scores at Day 90 and88% at Day 180, with longer-term follow-up ongoing.
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
Share Repurchase Update
-
Repurchased approximately
$100 million $49.43 -
Through the end of Q3 2026, TG has repurchased
$300 million 6% of the shares outstanding, at an average price of$33.88
2026 Financial Guidance Update
-
Raises full year 2026 target total global revenue to approximately
$1 billion -
Raises full year 2026 target BRIUMVI
U.S . net product revenue to approximately$915 -$920 million -
Reaffirms full year 2026 target operating expense (R&D and SG&A excluding non-cash compensation) guidance, of approximately
$450 $500 million
2026 Remaining Development Pipeline Anticipated Milestones
- Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027
Financial Results for Third Quarter 2026
-
Product Revenue, net: Product revenue, net was
$240.0 million $677.1 million $159.3 million $417.8 million the United States , which totaled$232.6 million $655.1 million U.S . licensing partner, Neuraxpharm, of$7.4 million $22.0 million $6.4 million -
License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately
$19.9 million $28.0 million $2.4 million $5.9 million $4.1 million $10.4 million U.S . partner, and$15.8 million $17.6 million -
R&D Expenses: Total research and development (R&D) expense was approximately
$51.3 million $195.0 million $40.9 million $119.0 million -
SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately
$80.7 million $251.0 million $63.4 million $169.3 million -
Net income: Net income was
$55.5 million $83.0 million $390.9 million $424.1 million $365.0 million -
Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were
$556.7 million
CONFERENCE CALL INFORMATION
The Company will host a conference call today, November 9, 2026, at 8:30 AM ET, to discuss the Company’s financial results from third quarter of 2026.
To participate in the conference call, please call 1-877-407-8029 (
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
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
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
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
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
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT in the
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support
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
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) enrolling patients into a trial evaluating BRIUMVI in MG or schizophrenia, or (iii) 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.
| 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 September 30, |
|
Nine months ended September 30, |
||||||||||||
|
|
2026 |
|
|
|
2025 |
|
|
|
2026 |
|
|
|
2025 |
|
Revenue: |
|
|
|
|
|
|
|
||||||||
Product revenue, net |
$ |
240,043 |
|
|
$ |
159,317 |
|
|
$ |
677,145 |
|
|
$ |
417,815 |
|
License, milestone, royalty and other revenue |
|
19,893 |
|
|
|
2,392 |
|
|
|
28,044 |
|
|
|
5,898 |
|
Total revenue |
$ |
259,936 |
|
|
$ |
161,709 |
|
|
$ |
705,189 |
|
|
$ |
423,713 |
|
|
|
|
|
|
|
|
|
||||||||
Costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of revenue |
|
42,079 |
|
|
|
28,093 |
|
|
|
116,783 |
|
|
|
62,572 |
|
Research and development: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation |
|
7,550 |
|
|
|
5,335 |
|
|
|
20,495 |
|
|
|
12,984 |
|
Other research and development |
|
43,740 |
|
|
|
35,543 |
|
|
|
174,528 |
|
|
|
106,038 |
|
Total research and development |
|
51,290 |
|
|
|
40,878 |
|
|
|
195,023 |
|
|
|
119,022 |
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation |
|
17,153 |
|
|
|
12,351 |
|
|
|
52,033 |
|
|
|
36,035 |
|
Other selling, general and administrative |
|
63,515 |
|
|
|
51,022 |
|
|
|
198,982 |
|
|
|
133,254 |
|
Total selling, general and administrative |
|
80,668 |
|
|
|
63,373 |
|
|
|
251,015 |
|
|
|
169,289 |
|
|
|
|
|
|
|
|
|
||||||||
Total costs and expenses |
|
174,037 |
|
|
|
132,344 |
|
|
|
562,821 |
|
|
|
350,883 |
|
|
|
|
|
|
|
|
|
||||||||
Operating income |
|
85,899 |
|
|
|
29,365 |
|
|
|
142,368 |
|
|
|
72,830 |
|
|
|
|
|
|
|
|
|
||||||||
Other expense (income): |
|
|
|
|
|
|
|
||||||||
Interest expense |
|
15,819 |
|
|
|
6,721 |
|
|
|
40,057 |
|
|
|
20,194 |
|
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
9,153 |
|
|
|
— |
|
Other income |
|
(3,782 |
) |
|
|
(3,265 |
) |
|
|
(11,301 |
) |
|
|
(9,661 |
) |
Total other expense |
|
12,037 |
|
|
|
3,456 |
|
|
|
37,909 |
|
|
|
10,533 |
|
|
|
|
|
|
|
|
|
||||||||
Net income before taxes |
$ |
73,862 |
|
|
$ |
25,909 |
|
|
$ |
104,459 |
|
|
$ |
62,297 |
|
Income tax (expense) benefit |
|
(18,399 |
) |
|
|
364,986 |
|
|
|
(21,438 |
) |
|
|
361,845 |
|
Net income |
$ |
55,463 |
|
|
$ |
390,895 |
|
|
$ |
83,021 |
|
|
$ |
424,142 |
|
|
|
|
|
|
|
|
|
||||||||
Net income per common share |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.39 |
|
|
$ |
2.69 |
|
|
$ |
0.58 |
|
|
$ |
2.90 |
|
Diluted |
$ |
0.35 |
|
|
$ |
2.43 |
|
|
$ |
0.52 |
|
|
$ |
2.62 |
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares of common stock outstanding |
|
|
|
|
|
|
|
||||||||
Basic |
|
140,786,274 |
|
|
|
145,416,901 |
|
|
|
142,318,594 |
|
|
|
146,273,554 |
|
Diluted |
|
155,925,050 |
|
|
|
160,997,977 |
|
|
|
157,741,254 |
|
|
|
162,102,373 |
|
Condensed Balance Sheet Information (in thousands): |
|||
|
September 30, 2026 (Unaudited) |
|
December 31, 2025* |
Cash, cash equivalents and investment securities |
556,709 |
|
199,511 |
Total assets |
1,592,252 |
|
1,063,253 |
Total equity |
572,127 |
|
648,020 |
|
|
|
|
* Condensed from audited financial statements |
|||
View source version on businesswire.com: https://www.businesswire.com/news/home/20261109560314/en/
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
Source: TG Therapeutics, Inc.