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The call conveyed strong, tangible commercial momentum: record Q1 revenue, 63% YoY U.S. growth, rising patient counts (25,000+), improved profitability, a robust cash position and aggressive share buybacks. Management also highlighted multiple near‑term clinical catalysts (ENHANCE, subcutaneous readouts) and longer‑term expansion opportunities (subcutaneous formulation, additional indications). Offsetting this optimism are near‑term expense increases (including ~$100M subcutaneous spend), a one‑time refinancing charge, notable gross‑to‑net/rebate pressure (~65% guidance), and clinical/regulatory timing and outcome risks for key lifecycle programs and the azer‑cel program. Overall, the positives (strong revenue beats, guidance raises, cash and buybacks, lifecycle catalysts, and supportive long‑term data) materially outweigh the listed challenges, though execution and trial outcomes remain critical to sustaining the trajectory.
TG Therapeutics raised its 2026 outlook after an outperformance in Q1: U.S. BRIUMVI net product revenue was approximately $195M in Q1 (above prior guidance of $185–190M), total net product revenue was $201M and total revenue was $205M; management now guides full‑year U.S. revenue of $885–900M and total global revenue of about $925M, with Q2 U.S. revenue targeted at ~ $220M and an annualized run‑rate toward $1B expected before year‑end. Financial guidance also includes full‑year operating costs of roughly $350M (R&D + SG&A, excl. stock‑based comp) plus ~ $100M for subcutaneous manufacturing and secondary manufacturer start‑up, a year‑average gross‑to‑net of ~65%, and Q1 OpEx of ~$117M; Q1 operating income was $34.8M and net income was $19.8M ($0.12/diluted). The company ended the quarter with ~ $573M in cash, repurchased >3M shares in Q1 (~$100M) and ~6.8M shares total to date at ~ $29 avg (~5% of shares), leaving ~153M shares outstanding, and noted >25,000 patients prescribed globally and 63% YoY U.S. growth; pipeline/timing guidance included ENHANCE top‑line and Phase I bioavailability data in the coming weeks, a fully enrolled subcu Phase III with top‑line around year‑end/early‑2027 and a potential 2028 subcu launch.
U.S. BRIUMVI net product revenue of ~$195M in Q1, above guidance of $185M–$190M and up 63% year-over-year; global revenue exceeded $200M and total revenue was $205M (including $3.6M license/royalty). Company raised full-year U.S. revenue guidance to $885M–$900M, full-year global revenue guidance to ~$925M, and is targeting Q2 U.S. revenue of ~ $220M. Management expects to approach a $1B annualized run rate before year-end.
Operating income of $34.8M in Q1 versus $8.6M a year ago (≈305% increase). Net income was $19.8M ($0.12/diluted) vs $5.1M ($0.03) a year ago (≈288% increase). Cash, cash equivalents and investment securities ended Q1 at ~$573M, up from roughly $200M at year-end (~186% increase), providing financial flexibility.
More than 25,000 patients prescribed BRIUMVI globally. Company reported its 12th consecutive quarter of sequential growth since launch, record new patient enrollments in Q1 with March the highest month ever, and an increasing mix of treatment‑naive patients—signaled as the strongest leading indicator for long-term share.
Phase III ENHANCE topline data (consolidated dosing eliminating day-15 infusion) and Phase I bioavailability data expected in the coming weeks. Subcutaneous Phase III study is fully enrolled with topline data expected year-end/early next year and a potential 2028 commercial launch if positive — a program management expects could nearly double the addressable market by enabling participation in both IV and subcutaneous anti-CD20 segments.
Five‑year follow-up data from ULTIMATE I & II open‑label extension published in JAMA Neurology demonstrating sustained efficacy and consistent safety/tolerability. AAN real-world data showed rapid, sustained B‑cell depletion, low annualized relapse rates, favorable infusion experience, and improvement in patient‑reported 'wearing off' after switching to BRIUMVI.
Expanded Blue Owl financing to enhance flexibility; repurchased ~$100M of stock during the quarter (over 3M shares at ~ $30 average). Since program launch, repurchased ~6.8M shares at ~ $29 average (~5% of shares outstanding), while remaining opportunistic on business development.
Advancing additional programs including planned Phase II (potentially registration‑directed) in myasthenia gravis, an exploratory study in treatment‑resistant schizophrenia, and progress on allogeneic anti‑CD19 CAR‑T (azer‑cel) in progressive MS — with clinical sites expressing higher demand than available slots.
Q1 OpEx (R&D + SG&A, ex stock comp) was ~$117M while management stated revenue growth continues to outpace expense growth. Reiterated full-year OpEx guidance of ~ $350M (ex stock comp) plus ~$100M for subcutaneous manufacturing/secondary manufacturer start-up, showing a planning framework for near-term investments.
Greetings, and welcome to the TG Therapeutics First Quarter Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Jenna Bosco, Chief Communications Officer. Thank you. You may begin.
Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' First Quarter 2026 Financial results are Michael Weiss, our Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercial Officer; and Sean Power, our Chief Financial Officer. Following our safe harbor statement, Mike will begin with an overview of our recent corporate developments. Adam will provide an update on our commercial efforts, and Sean will review our financial results before we open the call for Q&A. Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include expectations regarding our future operating and financial performance, including sales trends, revenue guidance, projected milestones, development plans and outlook for our marketed products and our pipeline products. Please note that these statements are subject to risks and uncertainties that can cause our actual results to differ materially from those indicated.
These risks are detailed in our SEC filings. Additionally, any forward-looking statements made today reflect our views only as of this date, and we disclaim any obligation to update or revise the...