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TG Therapeutics, Inc.
5/6/2026
Greetings and welcome to the TG Therapeutics first quarter conference 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, please press star zero on your telephone keypad. 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 product 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 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 now turn the call over to Mike Weiss, our CEO.
Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone, but because of the consistency and durability we're now seeing across the business. Let me start with the commercial side. At a high level, Q1 was a record-setting quarter across nearly every metric we track. The momentum puts us on a very strong position as we move through the rest of the year. From a revenue standpoint, we delivered approximately $195 million in U.S. free on the net product revenue in quarter one, ahead of our guidance of $185 to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone. And as we move toward a billion-dollar annualized run rate expected before year-end, we continue to believe we are still early in the BrionV adoption curve, making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today. Physicians are increasingly recognizing the value of BrionV, not just on efficacy, but on the overall treatment experience, and that's translating into durable, repeatable growth and, importantly, The data continues to support that differentiation. Earlier this year, we were pleased to see our five-year follow-up data from the ultimate one-in-two open-label extension study published in JAMA Neurology reinforcing sustained efficacy of BrionV along with a consistent safety and tolerability profile over time. At AAN earlier this month, we continued to build on that story with real-world data demonstrating sustained and rapid B-cell depletion low annualized relapse rates maintained over time, and continued evidence of a favorable infusion experience and tolerability profile. And for the first time, we presented prospective data from patients who switched from a prior anti-CD20 therapy to BRIOMV, which showed improvement in patient-reported wearing-off symptoms, sometimes referred to as a crop gap, after switching to BRIOMV. Given that meaningful number of patients report this wearing-off effect, The potential to address it represents a clear and differentiated use case. Turning to the pipeline. This is where we continue to invest in both strengthen and extend the franchise. First, our phase three enhanced study, evaluating initiation of RheumV therapy with a single 600 milligram IV infusion as compared to the currently approved schedule of 600 milligrams divided into two infusions, one on day one and one on day 15. I'm pleased to report that based on current timelines, we expect top line data from this phase three study in the coming weeks. Assuming a positive outcome and regulatory approval, we believe this positions us to launch the consolidated dosing schedule next year. This is about simplicity. Fewer infusions, same efficacy. And feedback on eliminating the day 15 infusion continues to be very positive from both patients and providers. Now turning to our subcutaneous program. We're developing a self-administered at-home version of Breon V, expected to be delivered via an auto-injector and a pen-like device. This program is designed to expand optionality, and importantly, expand the number of patients we can reach. The program began with a phase one dose escalation bioavailability study, evaluating sub-Q dosing relative to our approved IV schedule. Based on encouraging preliminary results, we advanced directly into our Phase III program. In Phase III, we are evaluating two subcube dosing schedules, every two months and quarterly dosing, with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks. We were pleased to report in April that the study is now fully enrolled, and we expect top-line data around year-end or early next year. Putting us on track for a potential 2028 launch of subcube re-OMV, assuming a positive outcome and regulatory approval. And I know many of you have been waiting for the phase one bioavailability data. We now expect to share those results in the coming weeks. Strategically, it's important to understand what sub-Q represents. This is not about incremental growth, and it's not about building a new infrastructure or entering a new indication. This is about expanding our reach within the same disease with largely the same physicians and commercial footprint. creating significant operating leverage. By enabling us to compete across both infusion and self-administered settings, we move from participating in a portion of the market to potentially participating across the entire anti-CD20 landscape. And as a result, we believe this has the potential to nearly double our addressable market with relatively limited incremental operating expense. Beyond relapsing MS, we are expanding the reach for Priyambi in additional autoimmune indications, review Burundi as a pipeline within a product. It's a long runway supported by patent protection into the 2040s. In myasthenia gravis, we've completed our phase one work and expect to initiate a phase two potentially registration-directed study this quarter. We're also initiating an exploratory study in treatment-resistant schizophrenia. There is emerging evidence suggesting an autoimmune component in a subset of these patients. It's early, but if validated, the implications could be significant. And finally, Azercel, our allogeneic anti-CD19 CAR T, continues to advance in progressive MS. Importantly, trial sites are identifying more patients than we currently have slots available, and additional sites continue to express interest in participating. This further highlights the unmet medical need in progressive MS. We look forward to sharing updates from this study later this year. Finally, I'd like to make a few remarks on our capital allocation. During the quarter, we expanded our relationship with Blue Owl enhancing our financial flexibility. This gives us the ability to continue repurchasing shares and pursue strategic business development opportunities. We've been clear. We view our stock as undervalued and we're acting on that. This quarter alone, we repurchased $100 million of our stock. At the same time, our approach to capital allocation is straightforward. We will continue to deploy capital where we see the best risk-adjusted long-term return whether that's in business, repurchasing shares, or pursuing external opportunities or investments. With that, I'm going to turn the call over to Adam Wallman, our Chief Commercialization Officer, for a more detailed commercial update. Adam, please go ahead.
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