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TG Therapeutics, Inc.
8/4/2025
Greetings. Welcome to TG Therapeutics' second quarter earnings call and webcast. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference call over to Jenna Bosco, Chief Communications Officer. Jenna, you may now begin.
Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second 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 provide an overview of our recent corporate development, Adam will share an update on our commercial 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 would 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 products. 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 therapeutic 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 we'll be available for the next 30 days. Now, I would like to turn the call over to Mike Weiss, our CEO.
Thank you, Jenna, and good morning, everyone, and thank you for joining us on today's call. I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business, highlighted by the continued momentum of our flagship product, BrionV. The ongoing enthusiasm from the MS community has been both gratifying and energizing, and our commercial performance has exceeded expectations. At TG, our mission is to bring forward therapies that truly improve the lives of those living with multiple sclerosis. Hearing real-world stories from individuals on BrionV is both validating and deeply inspiring. I encourage you to visit briambi.com to hear some of these patient experiences firsthand. Our commercial team remains disciplined and highly effective in executing our multi-year launch strategy. As a result, adoption continues to grow. Now, approximately two and a half years into launch, we estimate that nearly one in every three new IV anti-CV20 patients or prescribed BrionV. This represents meaningful progress toward our long-term goal of making BrionV the most prescribed anti-CD20 therapy for relapsing MS, as measured by dynamic market share. And as adoption continues to grow, we remain focused on expanding choice and flexibility for patients and providers through the development of sub-Q BrionV and our enhanced study. The development of sub-QBRIAMBI represents a strategic opportunity to further build a leadership role in the anti-CD20 space. If approved, sub-QBRIAMBI would significantly expand our addressable market by unlocking access to the 35% to 40% of the anti-CD20 dynamic market segment that currently prefers a self-administered option, of which only one is available today. We believe SubQ-Briumbi has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position PG as the only company offering both an IV and a self-administered option, potentially simplifying the treatment decision for patients and providers and positioning Briumbi as the anti-CD20 therapy of choice. Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal phase three trial for sub-Q BrionV in the coming weeks. This study will evaluate two dosing schedules every other month and quarterly compared to IV BrionV in patients with relapsing forms of MS. The primary endpoint is to demonstrate non-inferior exposure between sub-Q dosing and our approved IV dosing. We anticipate completing enrollment in 2026, filing a BLA in 2027, and pending approval, launching a sub-Q BRIOMV in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIOMV. I'm pleased to report that within the enhanced trial, we have begun enrollment into a randomized, double-blind, phase three cohort, evaluating the potential to consolidate the day one and day 15 infusions into a single 600 milligram infusion on day one. The goal of this study is to establish comparable exposure between the two dosing schedules. If successful, this simplified approach would eliminate the need for a second infusion in the first two weeks. offering what we believe would be a meaningful convenience benefit for patients and infusion centers. We look forward to pivotal data in 2026 with the goal of an updated label in 2027. Turning briefly to our pipeline, we are also pleased to share that we have dosed our first patient with progressive MS using Azercel, our investigational allogeneic CD19-directed CAR-T therapy. In parallel, we continue to explore the use of BRIUMV in myasthenia gravis as we consider additional opportunities to expand the uses of BRIUMV. This is an exciting time at TG. Our results this quarter reflect strong execution across both commercial and clinical fronts and a growing confidence in BRIUMV from physicians and patients alike. With continued progress on our sub-Q programs, enhancements to the IV experience and the advancement of our CD19 CAR-T into the clinic, we're laying the groundwork for sustained leadership in the MS space. With that, I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead.
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