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TG Therapeutics, Inc.
11/3/2025
Greetings, and welcome to the TG Therapeutics third quarter earnings call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Jenna Bosco, Chief Communications Officer. Please go ahead.
Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' third quarter 2025 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 would 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 the outlook for our marketed products. Please note that these statements are subject to risks and uncertainties that could 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 them. As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our website at www.tgtherapeutics.com. With that, I'll turn the call over to Mike Weiss, our CEO.
Mike? Thank you, Jenna, and good morning, everyone. I'm pleased to report that TG delivered another strong quarter. Our flagship product, Reumvi, for relapsing MS, continues to outperform, exemplifying what happens when innovation meets execution. We've always believed Brown V had a best in class profile, and we built what we believe is the best in class team around it. That combination, great product, great people tends to work out pretty well in most businesses. And it seems to be working out pretty well for us too. We're equally committed to continuing to innovate, to improve outcomes for those living with MS. That's what's driving the two pivotal studies we launched last quarter. The first enhance. explores in a randomized cohort whether we can consolidate the BrionV day one and day 15 doses into a single day one infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. The response from sites and patients has been tremendous, so much so that we've already completed enrollment. If all goes as planned, we should have data by the middle of next year and potentially a launch of this new, simplified dosing schedule in 2027. The second is our phase three subcutaneous lubletuximab study, what I'd like to call a true sub-Q product. Short push, auto-injector compatible, and designed for self-administration. We're testing two dosing schedules, once every other month and once quarterly. Enrollment is going quite well, and we believe we're on track to finish enrollment in the first half of next year, deliver top-line pivotal data in late 26 or early 27, and, if positive, setting the stage for potential approval and launch in 28. We view subcutaneous lubotuximab as a major opportunity that can nearly double the total addressable market for BrionV. And if approved, it would make TG the only company offering both IV and and self-administered CD20 options, we believe providing us with a unique competitive advantage. Subcute libituximab may also open up new opportunities for us. For example, we continue to explore the potential of BrionV and MG and have treated a small number of patients with encouraging results. Beyond BrionV, we're developing Azercel, our allogeneic CAR-T therapy for individuals with progressive MS. It's still early, but for people living with progressive MS, this type of therapy could be life-changing. Looking across our pipeline, I can envision the possibility of meaningful new launches in 27, 28, and 29, each with the potential to drive continued growth into the next decade. While we innovate, we also remain financially disciplined. We've seen a lot of deals in the market lately. Some look tempting. but we've chosen to stay patient and true to our principles. And when we can't deploy capital better inside the business, we return it to shareholders. During the quarter, we completed our initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50. The board has now authorized another $100 million program, giving us flexibility to keep doing what makes sense. Operationally, we continue to be profitable and growing, and expect that trend to continue, barring any one-time business development moves that might change the picture temporarily, but strengthen it in the long term. In closing, Q3 was another quarter of strong execution and meaningful progress. We're delivering on our commercial goals, advancing our development programs, and maintaining financial discipline, all while keeping patients at the center of everything we do. Now, I'll hand the call over to Adam Wallman, our Chief Commercial Officer, to provide a detailed Briambi launch update. Adam, go ahead.
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