TG Therapeutics(TGTX) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Developments Second Quarter 2025 Performance Highlights TG Therapeutics reported strong Q2 2025 financial results, with total revenue reaching $141.1 million and U.S. BRIUMVI net revenue growing 91% year-over-year, prompting an upward revision of 2025 full-year guidance | Metric | Q2 2025 | YoY Growth | QoQ Growth | | :----------------------- | :---------------- | :--------- | :------------------- | | Total Revenue | $141.1 Million | - | - | | BRIUMVI U.S. Net Revenue | $138.8 Million | 91% | 16% | - CEO Michael S. Weiss stated BRIUMVI is becoming a leading anti-CD20 therapy for adult RMS patients, with strong market acceptance, physician confidence, and patient experience supporting the revised full-year revenue guidance[2] BRIUMVI Commercialization & Publications BRIUMVI's commercialization expanded beyond the U.S. with approvals in Europe, UK, Switzerland, and Australia, alongside two medical journal publications highlighting its efficacy and differentiated characteristics in MS treatment - BRIUMVI has received approvals in the EU, UK, Switzerland, and Australia, expanding commercialization outside the U.S. through a partnership with Neuraxpharm[5] - Two medical journal articles were published: one on case series of switching from other anti-CD20 mAbs to Ublituximab, and another on the evolution of anti-CD20 MS therapies, emphasizing BRIUMVI's differentiated features[5] Pipeline Development & Future Goals The company made significant pipeline progress, including initiating a Phase III pivotal trial for IV BRIUMVI Day 1 and Day 15 co-administration and a Phase I trial for azer-cel in autoimmune diseases, with future plans for a subcutaneous BRIUMVI Phase III trial - A randomized Phase III pivotal program evaluating Day 1 and Day 15 co-administration of IV BRIUMVI in the ENHANCE trial has been initiated[5] - The first progressive multiple sclerosis patient has been dosed in a Phase I clinical trial for azer-cel in autoimmune diseases[5] - Remaining 2025 pipeline development goals include initiating a Phase III pivotal program for subcutaneous BRIUMVI, continuing to advance the simplified dosing regimen in the ENHANCE trial, and continuing enrollment in clinical trials for BRIUMVI and azer-cel in Myasthenia Gravis (MG) and autoimmune diseases, including progressive MS[5] Updated 2025 Financial Guidance TG Therapeutics raised its full-year 2025 U.S. BRIUMVI net product revenue and global total revenue targets, reflecting confidence in BRIUMVI's sustained strong performance | Metric | New Guidance (FY 2025) | Original Guidance (FY 2025) | | :----------------------- | :-------------------- | :-------------------- | | BRIUMVI U.S. Net Product Revenue | $570 - $575 Million | $560 Million | | Global Total Revenue | Approx. $585 Million | Approx. $575 Million | Detailed Financial Results Second Quarter 2025 Financial Performance The company achieved significant revenue growth and improved profitability in Q2 2025, driven by substantial increases in BRIUMVI net product revenue, while R&D and SG&A expenses rose due to product development and commercialization | Metric (Millions USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------- | :------- | :----------- | :----------- | | Net Product Revenue | 138.8 | 72.6 | 258.5 | 123.1 | | License, Milestone, Royalty & Other Revenue | 2.3 | 0.9 | 3.5 | 13.9 | | Research & Development Expenses | 31.8 | 17.6 | 78.1 | 50.3 | | Selling, General & Administrative Expenses | 55.6 | 38.8 | 105.9 | 73.4 | | Net Income (Loss) | 28.2 | 6.9 | 33.2 | (3.8) | - Increased R&D expenses are primarily attributed to manufacturing and development costs associated with the ublituximab subcutaneous formulation development[12] - Increased selling, general, and administrative expenses are mainly due to higher marketing, personnel, and external costs related to BRIUMVI commercialization[12] Statements of Operations (Income Statement) Detailed statements of operations show substantial growth in product revenue and net income for Q2 and H1 2025, reversing prior-year losses and reflecting the positive impact of BRIUMVI commercialization | Metric (Thousands USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------- | :------- | :----------- | :----------- | | Net Product Revenue | 138,843 | 72,596 | 258,498 | 123,084 | | Total Revenue | 141,148 | 73,466 | 262,004 | 136,939 | | Total R&D Expenses | 31,782 | 17,556 | 78,144 | 50,278 | | Total SG&A Expenses | 55,585 | 38,790 | 105,916 | 73,370 | | Operating Income (Loss) | 34,843 | 8,816 | 43,465 | (454) | | Net Income (Loss) | 28,187 | 6,879 | 33,247 | (3,828) | | Basic Net Income (Loss) Per Share | $0.19 | $0.05 | $0.23 | $(0.03) | | Diluted Net Income (Loss) Per Share | $0.17 | $0.04 | $0.20 | $(0.03) | Condensed Balance Sheet As of June 30, 2025, the company reported $278.9 million in cash, cash equivalents, and investment securities, with increases in total assets and total stockholders' equity compared to year-end 2024 | Metric (Thousands USD) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :----------------------- | :-------------------------- | :-------------------------- | | Cash, Cash Equivalents & Investment Securities | 278,860 | 311,001 | | Total Assets | 702,613 | 577,690 | | Total Stockholders' Equity | 276,432 | 222,364 | Cash Position and Funding Outlook As of June 30, 2025, the company held $278.9 million in cash, cash equivalents, and investment securities, anticipating that existing funds combined with projected BRIUMVI revenue will support current operations - As of June 30, 2025, cash, cash equivalents, and investment securities totaled $278.9 million[12] - The company anticipates that existing cash reserves, combined with projected BRIUMVI revenue, will be sufficient to fund operations according to current operating plans[12] Product Information: BRIUMVI About BRIUMVI BRIUMVI (ublituximab-xiiy) is a novel monoclonal antibody targeting CD20-expressing B-cells for relapsing multiple sclerosis (RMS), featuring glycoengineered design for efficient B-cell depletion at low doses, approved in the U.S., EU, and UK - BRIUMVI is a novel monoclonal antibody targeting CD20-expressing B-cells, designed with glycoengineering for efficient B-cell depletion at low doses[9] - BRIUMVI is approved in the U.S. for adult RMS patients, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; and in the EU and UK for adult RMS patients with active clinical or imaging features[10] Important Safety Information BRIUMVI carries important safety information, including contraindications, infusion reactions, infection risks, HBV reactivation, PML risk, vaccination considerations, fetal risk, and reduced immunoglobulin levels Contraindications BRIUMVI is contraindicated in patients with active Hepatitis B virus infection and those with a history of life-threatening infusion reactions to BRIUMVI - Contraindicated in patients with active Hepatitis B virus infection[22] - Contraindicated in patients with a history of life-threatening infusion reactions to BRIUMVI[22] Warnings and Precautions BRIUMVI requires vigilance for infusion reactions, infection risks (including serious bacterial and viral infections), HBV reactivation (requiring screening), PML risk (requiring monitoring), vaccination considerations, potential fetal harm, and reduced immunoglobulin levels - Infusion Reactions: Infusion reactions occurred in 48% of BRIUMVI-treated patients in MS clinical trials, with 0.6% being serious; pre-medication and post-infusion observation are required[13][14] - Infections: The overall infection rate in BRIUMVI-treated patients was 56%, with 5% serious infections and 3 infection-related deaths; administration should be delayed in patients with active infections[15] - Hepatitis B Virus (HBV) Reactivation: HBV screening is required before treatment, and BRIUMVI is contraindicated in patients with active HBV infection; HBV carriers or HBcAb+ patients should consult a hepatologist[17] - Progressive Multifocal Leukoencephalopathy (PML): While not observed in BRIUMVI-treated MS patients, it has been reported in patients treated with other anti-CD20 antibodies; BRIUMVI should be withheld and diagnostic evaluation performed if PML is suspected[18][19][20][21] - Vaccinations: Live or live-attenuated vaccines should be administered at least 4 weeks before BRIUMVI treatment, and non-live vaccines at least 2 weeks; live-virus vaccines are not recommended during treatment[23] - Fetal Risk: Animal studies indicate potential fetal harm; women of reproductive potential are advised to use effective contraception during treatment and for 6 months after the last dose[25] - Reduced Immunoglobulins: Serum immunoglobulin levels should be monitored during treatment, especially in patients with opportunistic or recurrent infections[26] Most Common Adverse Reactions In RMS clinical trials, the most common adverse reactions (incidence of at least 10%) for BRIUMVI were infusion reactions and upper respiratory tract infections - The most common adverse reactions (incidence of at least 10%) are infusion reactions and upper respiratory tract infections[27] BRIUMVI Patient Support Program The BRIUMVI Patient Support Program is a flexible initiative by TG Therapeutics designed for U.S. patients to provide comprehensive support throughout their treatment journey - The BRIUMVI Patient Support Program is a flexible program designed by TG Therapeutics for U.S. patients to support their treatment journey[29] Corporate & Disease Context About Multiple Sclerosis Relapsing Multiple Sclerosis (RMS) is a chronic demyelinating disease of the central nervous system, encompassing relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS), affecting approximately one million people in the U.S - Relapsing Multiple Sclerosis (RMS) is a chronic demyelinating disease of the central nervous system, including RRMS and SPMS[30] - Approximately one million people in the U.S. have MS, with about 85% initially diagnosed with RRMS, most of whom eventually develop SPMS[30] About TG Therapeutics TG Therapeutics is a fully integrated, commercial-stage biopharmaceutical company focused on acquiring, developing, and commercializing novel treatments for B-cell diseases, with BRIUMVI approved for RMS in multiple regions - TG Therapeutics is a commercial-stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel therapies for B-cell diseases[31] - BRIUMVI has received approvals from the U.S. FDA, European Commission, UK MHRA, Swissmedic, and Australian TGA for the treatment of adult patients with relapsing multiple sclerosis[31] Forward-Looking Statements Cautionary Statement This press release contains forward-looking statements subject to risks and uncertainties, where actual results may differ materially from expectations due to factors like BRIUMVI commercialization, regulatory approvals, and macroeconomic conditions - Forward-looking statements involve risks and uncertainties, and actual events or results may differ materially from expectations[33][34] - Risk factors include, but are not limited to: the continued ability to commercialize BRIUMVI, prescription trends, payer coverage, healthcare professional interest, sales momentum, achievement of revenue targets, regulatory approvals, reliance on third parties, differences between patient clinical experience and trial results, achievement of pipeline development milestones, and macroeconomic and political conditions[35][36] - The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of publication[37] Conference Call & Contact Information Conference Call Information TG Therapeutics held a conference call on August 4, 2025, to discuss Q2 2025 financial results, accessible to investors via phone or a live webcast on the company's website - The company held a conference call on August 4, 2025, at 8:30 AM ET, to discuss Q2 2025 financial results[7] - Participants can access the live audio webcast via a designated phone number or the "Events" page in the Investors & Media section of the company's website[8] Contact Information Investor Relations and Media Relations contact emails and phone numbers are provided - Investor Relations email: ir@tgtxinc.com, phone: 1.877.575.TGTX (8489), Option 4[38] - Media Relations email: media@tgtxinc.com, phone: 1.877.575.TGTX (8489), Option 6[38]