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TG Therapeutics, Inc.
5/5/2025
Greetings and welcome to TG Therapeutics' first quarter conference call and webcast. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Chief Communications Officer. Thank you. You may begin.
Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter 2025 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments. Adam will share an update on our commercialization efforts. And Sean will give a summary of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected milestones, revenue guidance, development plans, and expectations for our marketed product. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO.
Thanks, Jenna, and good morning, everybody, and thanks for joining us on today's call. It's a pleasure to be here with you and to provide an update on TG's continued progress, both in the successful launch of Re-Envy and in building a company committed to improving the lives of those living with multiple sclerosis. I'm excited to share that we kicked off 2025 with another strong quarter performance, underscoring the sustained momentum behind Realme. As you may have seen in the press release this morning, Realme US net sales reached nearly $120 million in the first quarter, once again, exceeding our expectations. This growth reflects both the increasing adoption by healthcare providers and a rising tide of patient interest and confidence in BRIOMV. Over the past month, I spent a significant amount of time in the field, meeting with prescribers, and it's energizing to see firsthand how BRIOMV is becoming the go-to anti-CD20 therapy for many of them. But what's even more gratifying is hearing directly from people living with MS. At a recent MS walk, I spoke with two individuals who shared their experiences switching to Brianvi from another approved IV anti-CD20 therapy. They both described how they previously felt unwell for days or more after each infusion, but not with Brianvi. Their stories echo findings from a recent paper in Frontiers in Immunology, which highlighted seven case reports of people with MS who switched to BrionV from a prior anti-CD20 due to issues like tolerability, disease activity, wearing off effects, or incomplete B-cell depletion. In each case, the unwanted effect either resolved or did not recur with BrionV. These real-world experiences support the idea that not all CD20s are the same and that switching within the class may make a difference. This point is reinforced by another recent publication in CNS Drugs, which explores how structural and mechanistic differences among CD20 therapies may drive variations in efficacy and tolerability. Word of mouth within the MS community is powerful, and we believe these success stories are helping to drive continued growth and enthusiasm. As I often say, the more people who start BrionV, the more people will start BrionV. And even in a highly competitive market, our team and Briomvy's unique profile are rising to the challenge. I couldn't be more proud of how our team has executed our multi-phase launch strategy and the strong start we've made in 2025 as we pursue our long-term goal of making Briomvy the number one prescribed anti-CD20 as measured by dynamic market share. In a moment, Adam Waldman, our Chief Commercialization Officer, will walk you through the commercial performance in more detail, as well as our investment priorities and updated guidance for Q2 and full year 2025. But first, I'd like to highlight our pipeline and efforts to enhance the BrionV experience. A core focus of our innovation strategy is simplifying the patient experience. Our enhanced clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results. We previously presented data from this study demonstrating the safety and tolerability of a 30-minute maintenance infusion, as well as initiating BrionV treatment with a single full-dose 450 milligram infusion for patients switching from another CD20 who had low B-cell counts. And most recently, at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BrionV with a single 600 milligram dose on day one, effectively eliminating the need for a day 15 dose. Feedback on this streamlined approach has been very positive. We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BrionV a true twice-a-year therapy from day one. We are now preparing to advance this regimen into a registration-directed trial. Another exciting initiative is the development of a self-administered sub-Q Briondi. While the vast majority of patients continue to prefer to receive their anti-CD20 as an IV infusion, there is a growing minority who are now choosing a self-administered subcutaneous option, of which there is only one available today. we see a clear opportunity to expand access and choice with a self-administered subcube reality. Our ongoing phase one safety and bioclobin study is showing promising results. The subcube injection appears to be well tolerated with bioavailability that appears to support every other month or even potentially quarterly dosing. We're pleased with the progress so far and on track to launch a pivotal trial this year. We also believe that sub-q formulation may open new doors for us and new indications. One area that we are currently exploring is the potential for sub-q Brionvy and myasthenia gravis, and we're evaluating potential additional indications as well. Finally, on the pipeline front, we continue to be excited about AzorCell, our allogeneic CD19 CAR-T cell therapy. Its early days for CAR-Ts and autoimmune diseases but we see great potential across multiple indications. We're excited to launch our phase one for Azercel in progressive forms of MS, a segment of the MS population with limited treatment options and poor prognosis. In closing, 2025 is off to a very strong start. We're executing on our commercial strategy, advancing our clinical programs, and expanding our manufacturing capacity to meet the growing demand. I want to thank the entire TG team for their dedication and hard work. It's their commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS. And now I'll turn the call over to Adam Wallman, our Chief Commercialization Officer. Adam, go ahead.
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