TGTX Q3 2026 earnings call transcript, November 9, 2026

Communications Officer. Please go ahead.

I thought it'd be valuable for investors to hear directly from our Chief Development Officer, Harry Miskin, who will take you through the key findings shortly. But first, I wanted to share some of my own observations from the conference. I had the opportunity to meet with over a hundred 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 Breambi 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 Enable are reinforcing some of these differences observed in clinical practice. And when clinical evidence meets personal experience, adoption follows. For me, that's how we'll achieve our ambition. Are 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 stud-tube renal-V. The first, which was... Studied in our positive phase three enhanced study would simplify the initiation of IV BriomV by combining the day one and day 15 initiation doses into a single infusion. If approved, BriomV would be the only IV anti-CD20 that offers this.

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 BriomV. In terms of timing, we're still targeting a potential approval of this new initiation dosing around mid-2027. The other, SubQ BriomV, represents our biggest near-term growth opportunity. Today, approximately 35% of new anti-CD20 treatment starts are for patients choosing stealth administration. It's a market in which BriomV 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. And with the potential for quarterly self-administration, we believe sub-Q BriomV could offer a compelling alternative to existing treatment options that require more frequent dosing. With phase three results expected around year end or early 2027. We're working toward a potential launch in 2028. And strategically, we see sub-Q as additive to our IV business, not a replacement for it. Our goal is to make BriomV a compelling treatment option, regardless of how patients prefer to receive therapy. Because we believe no. Both patients should have to choose their treatment solely based on route of administration.

Beyond these life cycle innovations, X-ROMs also offered an early glimpse of what could become an entirely new frontier in MS treatment, CART T-cell therapy. We are pleased to present the first clinical. results from Azercel are allogeneic CART T and 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're 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. And importantly, we don't believe our opportunities end with Briamvi interlapsing MS. We're exploring entirely new treatment approaches, including Azercel and progressive MS, while advancing Briamvi and Myasthenia Gravis, treatment-resistant schizophrenia, so we're going to be looking forward to seeing you next time. and potentially other indications. Each of these programs represents an opportunity to create additional value beyond our existing business, and we're pursuing them from the position of increasing financial strength. At the same time, we're committed to being disciplined with the capital. we're generating. Our objective remains clear to build a company capable of repeatedly creating value through scientific innovation, discipline, execution, and thoughtful investments that generate attractive long-term returns. I'm proud of what we've accomplished, but when I consider the opportunities in front of us,

I believe we're still early in the stage of what TGT can become. With that, I'll turn the call over to our Chief Development Officer, Harry Miskin, for a closer look at the clinical results from ECTRAMS and an overview of our development programs. Harry, welcome to the call.

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 relapsed-free. Infusion times were considered. with our approved one hour maintenance infusion, and rates of infusion-related reactions were lower than those observed in the registrational trials. Turning to enhanced, this Phase IIIb study initially focused on evaluating switches to BriantB from prior anti-CD20 therapy and has evolved over time to also explore all- alternate dosing registers for BriantB, yielding a number of valuable data sets. 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 three or higher infusion-related reactions in either arm. Resil depletion and MRI outcomes were also comparable for both regimens. Together, these findings support the potential to simplify bioequivalence 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 include

to incorporate this new regimen around the middle of 2027. We also presented an update on an earlier cohort from the enhanced study, which enrolled over 100 patients who transitioned directly from ocrelizumab to PriamV. Approximately 60% of these patients reported experiencing wearing-off symptoms while on ocrelizumab. However, following the transition to PriamV, 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 PriamV. 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. On that note, it's worth noting a recent publication in the journal Multiple Sclerosis and Related Disorders, which was a five-year comparison. comparative analysis of ubiduximab against both ocrelizumab and opitumumab. This peer-reviewed publication used an unanchored, match-adjusted methodology to account for differences between the clinical trial populations to provide a statistically valid comparison. The findings were particularly interesting. Ubiduximab was associated... with a 44% lower estimated risk of confirmed 24-week disability progression compared with ocrelizumab and a 49% lower risk compared with opitumumab. While these findings come from an indirect comparison rather than a randomized head-to-head trial, we believe the consistency of the results against both leading anti-CD20 therapies...

...is thought-provoking and warrants further investigation. Now turning to subcubriambi, the phase 1 results presented at ECTRAM support our quarterly dosing strategy. Estimated subcutaneous bioavailability was approximately 62%, and PK modeling of our 400mg quarterly dosing regimen predicts a geometric... ...mean ratio of exposure relative to IV-briambi of 1.20, with a lower bound of the 90% confidence interval that exceeds the non-inferiority threshold for success defined in our ongoing phase 3 study. The thrombocodynamic findings were equally encouraging. All patients receiving the fully subcutaneous 400mg... achieved B-cell depletion within four days, with depletion maintained throughout the dosing intervals. Importantly, the 400mg sub-Q injections were well tolerated, with limited local and systemic injection-related reactions observed, all of which were grade 1. The phase 3 study of sub-Q-briambi is fully enrolled, with top-life... ...results expected around year-end or early 2027. Assuming successful development and regulatory review, we continue to target a potential commercial launch in 2028. Lastly, turning to ADRACEL, our allogeneic CD19-directed CAR-T cell therapy, we presented the first clinical results from our phase 1 progressive MS study. in a late-breaking oral presentation and actions. The initial data set included 26 patients with progressive MS, all of whom had experienced disability progression despite high-efficacy treatment, including prior anti-CD20 therapy.

The median baseline EDSS score was 6.0, reflecting a population with substantial accumulated disability. The early safety findings were encouraging, with no dose-limiting toxicities observed across all dose levels, no grade 3 or higher CRS, no grade 2 or higher ICANs, no GDHC, and no grade 3 or higher infections observed. From a pharmacodynamic perspective, 25 of 26 patients achieved peripheral B-cell depletion, and there was early evidence of reduced B-cell counts in cerebrospinal fluid, a compartment generally inaccessible to current anti-CD20 therapy. Turning to the preliminary clinical findings, at day 90 post-CAR-T administration, nearly 90% of evaluable patients had stable or improved EDSS. With the longest followed patients sustaining a two point reduction for a year and a half and counting. While early, these observations are encouraging, particularly in a population with documented disability progression despite previous high efficacy therapy. We continue to follow these patients to assess longer term outcomes while advancing those. optimization and look forward to sharing additional updates as the data mature. Finally, we continue to advance BriomV into additional therapeutic areas beyond MS. Our phase two study in generalized myasthenia gravis is evaluating whether rapid disease control with SCRN inhibition followed by BriomV maintenance can provide more.

We are also conducting an exploratory phase two study in treatment-resistant schizophrenia to investigate whether B-cell depletion can provide clinical benefit in a patient population. where emerging evidence suggests immune dysfunction may contribute to disease biology. Both programs are designed to generate meaningful clinical evidence with a disciplined approach to development and investment, and additional programs in other therapeutic areas are also under development. Looking ahead, the next several years will be an important period across our development programs. And our team remains focused on executing against these opportunities. With that, I'll turn the call over to our Chief Commercial Officer, Adam Wollman, for a commercial update.

into Q4. Persistence remains strong. We're seeing a steady flow of new prescribers, along with continued growth and repeat prescribing, with October being a record for total Breon-B prescribers in a month. Our hospital business also delivered encouraging growth during the quarter. September and October were our strongest hospital months since November. launch. We've consistently viewed hospitals as an important opportunity, and we're beginning to see the benefits of the sustained effort we've made in this segment. Together, these trends are expanding our installed base of patients returning approximately every six months for treatment. And as that installed base grows, it creates decrease an increasingly durable and predictable foundation of recurring revenue. We're also seeing an important evolution in where Briombi fits in the treatment journey. Treatment naive patients now represent approximately 40% of our new patient business compared with approximately 25% at launch. We're also seeing increasing adoption among younger women ages 18. This is an important shift. It tells us that physicians are increasingly comfortable choosing Briombi as an initial high efficacy treatment rather than waiting until a patient has experience with another therapy. At the same time, approximately one-third of our new patient starts continue to come from patients transitioning from another CD20 therapy.

a portion that has remained remarkably stable since launch. What's particularly encouraging is that we continue to attract these patients even as the competitive landscape evolves, including efforts by other manufacturers to transition patients from their IV to subcutaneous formulation. Taken together, these trends demonstrate the increasing relevance of Briambi, both as an initial treatment choice and as an option for patients considering a change in therapy. We're also beginning to see the benefits of the commercial investments we've made. Our expanded field organization is contributing to growth in new patient starts by increasing educational efforts with established prescribers. and expanding our reach among physicians with less Breambi experience. Complementing that field effort, our direct-to-consumer initiatives are building awareness and confidence in Breambi and encouraging conversations with healthcare providers. We're now seeing measurable results, including increases in aided and non-aided awareness and prescription lifts. associated with our campaigns. We're also investing in data analytics and AI-enabled tools to improve field targeting, personalized physician education, and help us deploy our commercial resources more effectively. Our objective is straightforward to support continued growth while increasing the productivity and information. Scalability of our commercial organization. Looking ahead, we see two important opportunities to significantly expand the BreonBee franchise. The first is the simplified IV single dose initiation regimen. We see this as more than an incremental enhancement. Based on physician feedback and our market research, we've

believe eliminating the second initiation of fusion could become a meaningful driver of additional demand, providing further potential tailwinds to our IV business in the second half of 27 and beyond. With that in mind, we're actively preparing for a potential launch around the middle of 2027. The second opportunity is our investigational SubQ-Briambi formulation designed for self-administration once every three months. We believe the addition of SubQ can more than double Briambi peak sales opportunity by opening an entirely new segment of the anti-CD20 market where we don't currently participate. And importantly, we believe we're particularly well positioned to capture. this opportunity with an established brand, broad physician awareness and existing commercial infrastructure. We have the potential to generate substantial new revenue without having to build an entirely new commercial organization. That's the operating leverage that makes this opportunity especially attractive. As Mike discussed, our strategy is to continue supporting. both IV and sub-Q Breambi. We're not looking to replace one business with another. We're looking to build two substantial businesses under one brand. And with our intellectual property portfolio extending into the mid-2040s, we believe we have the opportunity to continue investing in both formulations for years to come. Together, the opportunity to reach more patients, build on our existing commercial infrastructure, and invest behind a long patent runway gives us confidence in Briambi's substantial long-term growth potential. In summary, we continue to build momentum. Our core business metrics support our increased full year.

U.S. revenue guidance of $915 to $920 million and our expectation for a strong fourth quarter and full year 2026. With future opportunities to strengthen IV and a potential multi-billion dollar opportunity in self-administered treatment, we see substantial growth ahead. Our focus is on finishing 2026 strong and capitalizing on the opportunities in 27 and beyond. With that, I'll turn the call over to Shawn for a review of our financial results.

Let me walk through the financial results for the quarter and touch on a few items worth highlighting. As Mike and Adam mentioned, commercial performance remains strong. U.S. BriMV net product revenue was $233 million in the third quarter, up 52% from a year ago. Total net product revenue was $240 million, when including $7.4 million in product sales to NeuroXfarm, or ex-USB. partner. We also recognized $19.9 million of license, milestone, royalty, and other revenue, including a $10 million sales milestone from our ex-US partner, bringing total revenue for the quarter to approximately $260 million, up 61% year-over-year. U.S. free envy gross margin remained strong and consistent at 87% for the quarter. Consolidated gross margin was approximately 84%, reflecting the mix of U.S. sales, partner shipments, and other revenue. Turning to expenses. R&D and SG&A, excluding stock-based compensation, totaled approximately $107 million for the quarter, including roughly $10 million related to subcutaneous Breambi manufacturing and secondary source manufacturing. This compares to $150 million in total. operating expenses in Q2 of this year, with the sequential decline driven primarily by lower spending on those manufacturing activities, which were particularly elevated in the prior quarter. With that spending profile, we generated operating income of $86 million. for the quarter, compared to $29 million in Q3 of last year. Net income was $55.5 million, or $0.35 per diluted share. One point worth noting on the year-over-year comparison, Q3 of 25 included a substantial non-

cash income tax benefit from the release of our deferred tax valuation allowance, which significantly increased reported earnings in that period. Turning to the balance sheet and capital allocation, we ended September with approximately $557 million in cash. Cash equivalents and investment securities. During the third quarter, we repurchased $100 million of our common stock, representing roughly 2 million shares at an average price of approximately $49 per share. Across all of our repurchase programs to date, we've repurchased $300 million of our common stock, or roughly 8.9 million shares, at an average price less than $34 per share. That represents nearly 6% of our shares outstanding when we initiated the repurchase program. We've focused on disciplined capital allocation, balancing investment in the business with opportunities to return capital to shareholders. Looking ahead, we're raising our full-year revenue outlook to $915 to $920 million in U.S. Breembe net product revenue. And approximately $1 billion in total global revenue, including projected payments from our ex-U.S. partner. On spending, we continue to expect full-year R&D and SG&A expenses, excluding stock-based comp, to be in line with our prior guidance. Of $450 to $500 million, inclusive of those subcutaneous Breambi manufacturing and secondary source manufacturer startup activities. Overall, it was another strong quarter financially. We delivered significant revenue growth, generated

in-

meaningful profitability, and continued investing in the business while returning capital to shareholders. With that, I'll hand the call back over to the operator to begin the Q&A.

Thank you very much.