TG Therapeutics 2026 Q3 Earnings Call

Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics Third Quarter 2026 Financial Results are Michael Weiss, our Chairman and Chief Executive Officer, Hari Miskin, our Chief Development 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. Hari will then discuss highlights from our recent data presentations, followed by Adam, who will provide an update on our commercial efforts. Sean will conclude our prepared remarks with a review of 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 the 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 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 today. I'm pleased to report another strong quarter for TG, with meaningful progress across both our commercial business and development programs. Global revenue for the quarter was approximately $260 million, including $233 million in U.S. BRIUMVI net revenue. With solid third quarter performance and trends pointing to a strong fourth quarter, we're raising our full-year global revenue guidance to $1 billion for 2026, a pretty remarkable accomplishment less than four years after launching BRIUMVI. I'd like to pause here to congratulate our team for their hard work and dedication to the MS community and to TG. As they know, we're just getting started. A billion dollars in annual revenue is an important milestone, but I don't believe it comes close to defining the opportunity ahead of us.

On our last call, I described BRIUMVI as a starting line for TG, providing the commercial capabilities, financial resources, and scientific foundation to build a value creation engine. I think the progress we've made over the last several months offers a compelling example of what that means. Nowhere was that progress more evident than at this year's ECTRIMS meeting in Toronto. We presented an extensive collection of data, ranging from seven-year clinical outcomes to new real-world evidence, life cycle innovations, and the first clinical results from azer-cel in progressive MS. Given the breadth of these presentations, I thought it'd be valuable for investors to hear directly from our Chief Development Officer, Hari Miskin, who will take you through the key findings shortly. First, I wanted to share some of my own observations from the conference.

I had the opportunity to meet with over 100 physicians and advanced practice providers during the conference. Conversation after conversation reinforced just how far we've come and the growing appreciation for the value BRIUMVI and TG are bringing to the MS community. I was particularly encouraged by the growing recognition that not all anti-CD20 therapies are the same, and that those differences may translate into meaningful differences in the treatment experience. What I found most interesting is how the data from ENHANCE and ULTIMATE are reinforcing some of these differences observed in clinical practice. When clinical evidence meets personal experience, adoption follows. For me, that's how we'll achieve our ambition of becoming the most prescribed anti-CD20 therapy among new MS treatment starts. We believe two important innovations can help accelerate our progress toward that goal: the consolidated IV initiation dose and self-administered subcu BRIUMVI.

The first, which was studied in our positive phase III ENHANCE study, would simplify the initiation of IV BRIUMVI by combining the day one and day 15 initiation doses into a single infusion. If approved, BRIUMVI would be the only IV anti-CD20 that offers the simplicity of a single initiation infusion, followed every six months by a one-hour maintenance infusion. We believe that combination could represent a meaningful competitive advantage for IV BRIUMVI. In terms of timing, we're still targeting a potential approval of this new initiation dosing around mid-2027. The other, subcu BRIUMVI, represents our biggest near-term growth opportunity. Today, approximately 35% of new anti-CD20 treatment starts are for patients choosing self-administration, a market in which BRIUMVI doesn't currently participate, and we believe this segment alone represents a multi-billion dollar opportunity. But here's what makes the opportunity particularly attractive to TG. We're not starting from scratch.

We already have an established brand, a growing physician network, and a commercial infrastructure serving the same MS community. With the potential for quarterly self-administration, we believe subcu BRIUMVI could offer a compelling alternative to existing treatment options that require more frequent dosing. With phase III results expected around year-end or early 2027, we're working toward a potential launch in 2028. Strategically, we see subcu as additive to our IV business, not a replacement for it. Our goal is to make BRIUMVI a compelling treatment option regardless of how patients prefer to receive therapy, because we believe no patient should have to choose their treatment solely based on route of administration. Beyond these life cycle innovations, ECTRIMS also offered an early glimpse of what could become an entirely new frontier in MS treatment, CAR T-cell therapy.

We were pleased to present the first clinical results from azer-cel, our allogeneic CAR T, in progressive MS, where there remains a significant unmet medical need. Let me close with where I see TG today and where we are going. We are delivering on our commercial commitments, raising our outlook, and building a business that we believe has the potential to become substantially larger than it is today. Importantly, we do not believe our opportunities end with BRIUMVI in relapsing MS. We are exploring entirely new treatment approaches, including azer-cel in progressive MS, while advancing BRIUMVI in myasthenia gravis, treatment-resistant schizophrenia, and potentially other indications. Each of these programs represents an opportunity to create additional value beyond our existing business, and we are pursuing them from a position of increasing financial strength. At the same time, we are committed to being disciplined with the capital we are generating.

Our objective remains clear, to build a company capable of repeatedly creating value through scientific innovation, disciplined execution, and thoughtful investments that generate attractive long-term returns. I am proud of what we have accomplished, but when I consider the opportunities in front of us, I believe we are still early in the stages of what TG can become. With that, I will turn the call over to our Chief Development Officer, Hari Miskin, for a closer look at the clinical results from ECTRIMS and an overview of our development programs. Hari, welcome to the call.

Thank you, Mike, and good morning, everyone. I am pleased to join you all today to provide an update on our clinical development programs and highlights of our recently presented data. As Mike mentioned, ECTRIMS was a particularly productive meeting for TG, the largest in the company's history in terms of the breadth and depth of data shared, with presentations highlighting long-term outcomes of BRIUMVI, continued differentiation versus others in the class, progress across our life cycle programs, and encouraging initial results from azer-cel in progressive MS. I will begin with BRIUMVI, where investigators at ECTRIMS presented seven-year follow-up results from the ULTIMATE clinical development program. These results continue to demonstrate sustained efficacy. Among patients who completed seven years of continuous BRIUMVI treatment, the annualized relapse rate was 0.018, roughly one relapse in over 50 patient years, and approximately 88% remained free of 24-week confirmed disability progression.

To our knowledge, this is an unprecedented level of freedom from disability progression in longer-term follow-up studies originating from phase III relapsing MS trials. The safety findings were also reassuring, with no new safety signals observed over seven years of treatment. Together, these results reinforce our confidence in BRIUMVI as a long-term treatment option for people living with relapsing MS. We also presented updated real-world findings from ENABLE, our ongoing U.S. phase IV observational study, which now includes more than 1,000 patients. The results continue to reinforce the clinical profile we saw in our registration trials. 99% of patients remained relapse-free, infusion times were consistent with our approved one-hour maintenance infusion, and rates of infusion-related reactions were lower than those observed in the registrational trials.

Turning to ENHANCE, this phase IIIb study initially focused on evaluating switches to BRIUMVI from prior anti-CD20 therapy, and has evolved over time to also explore alternate dosing regimens for BRIUMVI, yielding a number of valuable datasets. The study culminated in a randomized trial to evaluate consolidating our approved two-dose initiation regimen into a single 600 milligram initiation infusion, with the goal of making treatment initiation more convenient for patients and providers. The trial met its primary endpoint, demonstrating bioequivalence between the two regimens. Importantly, day one infusion-related reactions were numerically lower with the single-dose initiation regimen, 16% compared to approximately 26% for the standard regimen, with no grade 3 or higher infusion-related reactions in either arm. B-cell depletion and MRI outcomes were also comparable for both regimens. Together, these findings support the potential to simplify BRIUMVI initiation without compromising drug exposure or the observed safety profile.

We are advancing the regulatory process and, subject to approval, anticipate a potential update to our label to incorporate this new regimen around the middle of 2027. We also presented an update on an earlier cohort from the ENHANCE study, which enrolled over 100 patients who transitioned directly from ocrelizumab to BRIUMVI. Approximately 60% of these patients reported experiencing wearing-off symptoms while on ocrelizumab. However, following the transition to BRIUMVI, nearly 70% did not report this wearing-off effect through week 48 of treatment. Interestingly, this switch cohort also contained a number of patients who experienced incomplete B-cell depletion or early repletion on ocrelizumab, yet were able to obtain robust B-cell depletion with BRIUMVI. We believe these findings further support the potential for meaningful biological differences among anti-CD20 therapies, and we intend to continue investigating these observations and their potential clinical significance.