Greetings, and welcome to the TG Therapeutics third quarter 2026 conference call. 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 during the conference, please press star zero on your telecom keypad. Please note this conference is being recorded. I would now like to turn the call over to your host, Jenna Bosco, Chief Communications Officer. Please go ahead.
Thank you. 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 ENABLE 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 mg 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. 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.
On that note, it is worth noting a recent publication in the journal Multiple Sclerosis and Related Disorders, which was a five-year comparative analysis of ublituximab against both ocrelizumab and ofatumumab. 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. Ublituximab was associated with a 44% lower estimated risk of confirmed 24-week disability progression compared with ocrelizumab, and a 49% lower risk compared with ofatumumab. 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 subcu BRIUMVI. The phase I results presented at ECTRIMS support our quarterly dosing strategy.
Estimated subcutaneous bioavailability was approximately 62%, and PK modeling of our 400 mg quarterly dosing regimen predicts a geometric mean ratio of exposure relative to IV BRIUMVI 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 III study. The pharmacodynamic findings were equally encouraging. All patients receiving the fully subcutaneous 400 mg regimen achieved B-cell depletion within four days, with depletion maintained throughout the dosing intervals. Importantly, the 400 mg subcu injections were well tolerated, with limited local and systemic injection-related reactions observed, all of which were grade one. The phase III study of subcu BRIUMVI is fully enrolled, with top-line 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 azer-cel, our allogeneic CD19-directed CAR T-cell therapy, we presented the first clinical results from our phase I progressive MS study in a late-breaking oral presentation at ECTRIMS. The initial dataset 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 three or higher CRS, no grade two or higher ICANS, no GvHD, and no grade three 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 scores, with the longest followed patient sustaining a 2-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 dose optimization and look forward to sharing additional updates as the data mature. Finally, we continue to advance BRIUMVI into additional therapeutic areas beyond MS. Our phase II study in generalized myasthenia gravis is evaluating whether rapid disease control with FcRn inhibition, followed by BRIUMVI maintenance, can provide more durable benefit while reducing the burden of ongoing treatment.
This study has generated a lot of excitement as it explores a novel way to sequence therapies in MG to maximize their benefit. We are also conducting an exploratory phase II 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 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 Waldman, for a commercial update.
Thank you, Hari, and good morning, everyone. We continue to build on BRIUMVI's commercial success with broader physician adoption and a growing base of patients on treatment. As Mike noted, third quarter U.S. BRIUMVI net revenue reached approximately $233 million, our 14th consecutive quarter of sequential growth. As we discussed on our last call, we expected second-half growth to be primarily driven by the fourth quarter, which is exactly what we're seeing. With our core business metrics continuing to strengthen and a projected strong fourth quarter, we are raising our BRIUMVI U.S. net product revenue guidance from $890 million to $905 million to a new range of $915 million-$920 million, reflecting more than $260 million for the fourth quarter, w hich takes the U.S. BRIUMVI business above a billion-dollar annualized revenue run rate for the first time. Behind these results, we continue to see progress across our key commercial priorities.
BRIUMVI is strengthening its competitive position and has become an increasingly important choice in the MS market. As Mike and Hari discussed, our long-term and real-world data are helping physicians better understand BRIUMVI's differentiated profile. These findings reinforce what physicians are seeing in practice and give them more reasons to consider BRIUMVI for their patients. We believe that combination of evidence and experience is building confidence and contributing to broader adoption. New patient starts continue to grow year-over-year, and we have seen an acceleration at the end of Q3 and continuing into Q4. Persistence remains strong. We are seeing a steady flow of new prescribers along with continued growth in repeat prescribing, with October being a record for total BRIUMVI prescribers in a month. Our hospital business also delivered encouraging growth during the quarter. September and October were our strongest hospital months since launch.
We have consistently viewed hospitals as an important opportunity, and we are beginning to see the benefits of the sustained effort we have 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 an increasingly durable and predictable foundation of recurring revenue. We are also seeing an important evolution in where BRIUMVI fits in the treatment journey. Treatment-naive patients now represent approximately 40% of our new patient business, compared with approximately 25% at launch. We are also seeing increasing adoption among younger women, ages 18 to 40. This is an important shift. It tells us that physicians are increasingly comfortable choosing BRIUMVI 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 is 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 BRIUMVI, both as an initial treatment choice and as an option for patients considering a change in therapy. We are also beginning to see the benefits of the commercial investments we have 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 BRIUMVI experience. Complementing that field effort, our direct-to-consumer initiatives are building awareness and confidence in BRIUMVI and encouraging conversations with healthcare providers.
We are now seeing measurable results, including increases in aided and unaided awareness and prescription lift associated with our campaigns. We are also investing in data analytics and AI-enabled tools to improve field targeting, personalize physician education, and help us deploy our commercial resources more effectively. Our objective is straightforward: to support continued growth while increasing the productivity and scalability of our commercial organization.
Looking ahead, we see two important opportunities to significantly expand the BRIUMVI 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 believe eliminating the second initiation infusion could become a meaningful driver of additional demand, providing further potential tailwinds to our IV business in the second half of 2027 and beyond. With that in mind, we are actively preparing for a potential launch around the middle of 2027.
The second opportunity is our investigational subcu BRIUMVI formulation, designed for self-administration once every three months. We believe the addition of subcu could more than double BRIUMVI peak sales opportunity by opening an entirely new segment of the anti-CD20 market where we don't currently participate. 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 subcu BRIUMVI. We're not looking to replace one business with another. We're looking to build two substantial businesses under one brand.
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 BRIUMVI'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 million-$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 2027 and beyond. With that, I'll turn the call over to Sean for a review of our financial results.
Thanks, Adam. 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. BRIUMVI 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 Neuraxpharm, our ex-U.S. partner. We also recognized $19.9 million of license, milestone, royalty, and other revenue, including a $10 million sales milestone from our ex-U.S. partner, bringing total revenue for the quarter to approximately $260 million, up 61% year-over-year. U.S. BRIUMVI gross margin remains 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 BRIUMVI 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 2025 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 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 remain 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 million to $920 million in U.S. BRIUMVI 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 million-$500 million, inclusive of those subcutaneous BRIUMVI manufacturing and secondary source manufacturer startup activities. Overall, it was another strong quarter financially. We delivered significant revenue growth, generated 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. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question will come from Michael DiFiore with Evercore ISI.
Hey, guys. Thanks so much for taking my questions, and congrats on the progress this quarter. Two questions from me. One on gross-to-net. Last month, one of your competitors noted that BRIUMVI was gaining share through aggressive contracting, and that is probably not sustainable. You've guided to gross-to-net averaging around 65% this year. My question is whether you need a deeper gross-to-net in 2027 to maintain BRIUMVI's current payer access. Separately, my second question is, just given the BTK inhibitor data sets presented at ECTRIMS, I'm curious to get any updated thoughts on how we should think about this competitor class of drugs. Thank you.
Great. Thanks, Michael, for the questions. Really appreciate it. Adam, maybe you could take part one, the gross-to-net and our competitor's comments about our gross-to-net.
Yep. Yep. Thanks for the question, Mike. First of all, I think it's great that the competitor's talking about us on their calls. Clearly, we're having an impact on their business. To be clear, our contracting approach is both competitive and, we believe, 100% sustainable. Our strategy has always been to ensure we are competitive while maintaining discipline around the economics. Essentially, we want physicians to choose based on the clinical profile and the patient's needs. We firmly believe physicians are reaching for BRIUMVI due to the clinical advantages of the drug. As far as gross-to-net, your question there, I mean, over time, there will always be pressure on gross-to-net, not simply from contracting, but from payer mix, government discounts, and other factors.
We do use price increases to help offset the impact of these discounts to try to keep our net price as stable as possible. Our goal is to keep BRIUMVI competitive and accessible while building a profitable franchise. You see here, we continue to raise our net revenue guidance, just raised it again today. So we believe our performance to date demonstrates we can do just that. Hopefully that answers your question and puts that concern to rest.
Thanks, Adam. As for the BTK question, I'm going to start, then I'll let Hari get a chance at his first Q&A on our quarterly call. As I've said prior to any data on BTK, and my opinion hasn't changed, that the BTK as a group, whatever comes of it, is really a competitor in the oral category. Even today, as we talk about 50%, 55%, whatever the exact number is, it is somewhat hard to get exact on it, that are going on to anti-CD20s, that still means 50%- 45% are going on to something else. The vast majority of those are going on to the oral category, maybe upwards of 30%- 35%. So it's a relatively large but genericized oral marketplace, which is where we think and have always believed the BTK class will fit in.
In terms of competitive dynamics overall, we've never been concerned about it, and we're still not concerned about it. But maybe, Hari, you can just give some initial impressions on the actual data that we saw at the conference.
Yeah. Thanks, Mike. I completely agree with you that this will probably compete primarily in the oral space. The class itself has unfortunately been plagued with issues and really not lived up to what we were hoping. I think remibrutinib has gotten closest with the cleanest safety profile, but unfortunately, the efficacy for that agent has really fallen short, I think, of what we were expecting in terms of relapse rate reductions and MRI outcomes, certainly when compared to CD20s. It's also twice a day, which is worth noting because we continually hear that compliance is a key concern in this patient population, especially when you compare it to a twice-a-year IV option or hopefully a four-times-a-year subcu option. So we've had a number of discussions with clinicians and key opinion leaders, and we really don't see it competing in the high-efficacy space of CD20s.
Great. Thanks so much.
Thanks, Hari. Thanks, Michael. Appreciate the questions.
Our next question will come from Tara Bancroft with TD Cowen.
Hi, this is Greg Torres on for Tara. Congrats on the progress, and thank you for taking our question. In light of the guidance raise, how should we think about the exit velocity going into 2027, particularly with the simplified IV initiation potentially arriving around mid-year? Thank you.
Sure. Thanks for the question, Greg. Adam, you want to chat a little about that?
Yeah, sure. As far as 2027 goes, we've not given guidance for 2027. We'll do that through the normal process, but I think it's worth reinforcing that our underlying business, the metrics continue to strengthen. New patient demand is increasing. We saw acceleration at the end of Q3 and into Q4. In fact, last week, we saw a new record on new patient enrollments into our hub. Repeat prescribing is expanding, persistence remains strong, and our hospital business is growing, as I said in the prepared remarks. Taken together, all that supports our expectation for a strong fourth quarter and another raise to our full-year guidance here. We'll continue to ride that momentum into 2027 with a larger recurring patient base and continued opportunities to broaden physician adoption. As we discussed, the existing IV business we still think has substantial room to grow.
As we mentioned in the prepared remarks, a potential mid-2027 launch of the ENHANCE initiation regimen could provide an additional driver, subject to FDA approval, and we're preparing for that launch. So we feel very good about the continued growth into 2027, and we'll give formal guidance at the appropriate time.
Thanks, Adam.
We'll go next to Roger Song with Jefferies.
Excellent. Congrats for the quarter, and thanks for taking our question. Maybe a couple questions related to the subcu. First of all, can you let us know what will be the dosing form at the launch? Basically, just the prefilled or auto-injection, how many injections are needed, given you have a higher dose? Then how ready is FDA for the CMC, et cetera, outside of the phase III data you will report around the year-end? Then two is, we know Roche will report on-body injector data sometime next year as well. What's the feedback you've been getting from the community related to this kind of a more convenient subcu versus on-body injector, and how do you think this will impact the overall opportunity for subcu BRIUMVI? Thank you.
Thanks, Roger, for the questions. Subcu dosing at launch was your first question. Maybe I'll just chime in, and if Hari has something to add, please feel free to do so at the end. Our plan is to launch with an auto-injector. As we've discussed previously, we're going to be having the phase III data will come in year-end, early next year. We'll be preparing the BLA. The bridging study comes in a little bit after that. We'll be in the package, so we will, I think, somewhat uniquely be able to launch with an auto-injector when we do so in 2028. Anything else, Hari, you want to add on top of that from the question?
Yeah, only to add that CMC readiness is built into that timeline for a 2028 launch. As far as feedback on the on-body injector versus our product, our product is an auto-injector pen-like device that the community is used to using, and so the feedback we've gotten is very positive for what we anticipate to launch with.
Perfect.
Thank you.
We'll hear next from William Wood with B. Riley Securities.
Thanks for taking our questions, and congrats on the quarter. Maybe just digging in a little bit more to how you are seeing the new patients versus patients switching away from BRIUMVI. Could you discuss just a little bit more on how you are seeing internally those dynamics maybe playing out? Then also, in terms of your combined dosing expected in the second half of 2027, how are you thinking about the growth dynamics between first half and second half 2027, if obviously approved? Would you expect the pricing dynamics to change surrounding that reduction in loading doses? Essentially, is the price just those two doses combined, or is there something else that might be adjusted in there? Thank you.
Sure. Thanks for the question, William. Could you do me a favor, though? Can you just clarify your first question?
When we are thinking about the dynamics of your growth here, you obviously have new patients coming in and then patients that fall off or switch off. You have obviously given some color on the new patients coming in, but I was curious, alongside those new, what is the dynamics of the patients that may be leaving BRIUMVI?
Great. Thank you for the question. I have got you now. I will just mention at a high level, and then Adam, if you have something to add to that, and then we can talk about the growth dynamics in the second half to the combined starting dose. In terms of new patients, we have talked about new patient growth, as you mentioned. We also talk about persistence, which is basically the other side of that coin, right? We have said previously that we have not given out the numbers on the persistence rates, but we have talked about the persistence is high and higher than we expected. I think generally speaking, I could say with pretty good confidence that there is definitely more new patients coming in than patients we are losing into this system. I do not think I have any particular numbers.
I don't know that Adam does either, but anything to add to that, Adam?
No, I think you got it.
Okay. In terms of the growth dynamics of the combined dosing, assuming sort of a mid-2027 approval of that, what would be the impact? Adam, you want to take a crack at that one?
Yeah, as far as the question goes about pricing, I think that was the question, right? Pricing. There is no pricing change. There will be no impact on the pricing of BRIUMVI with the combined dose, and we're just taking two doses and combining it into the first dose. So, no change in pricing.
And growth dynamics, Adam?
No growth. That would not affect gross-to-net .
No, not gross-to-net . You were asking, William, about growth dynamics, not GTN, right?
Correct. First half versus sort of second half, once it is approved.
Yeah. I think the short answer, and I'll let Adam chime in, of course, after, is I don't think that we'd expect an immediate impact in, let's say, if it's the middle of the year, the third quarter. I think it's something that probably starts to see impact in the fourth quarter. There is a process to get it launched at all the centers. Yeah, I would assume, in terms of the lift, it's probably the latter part of the second half of the year before we start to see the lift from that approval, if assuming we get approved. Adam, anything on top of that?
Yeah, that's right. Sorry, I misunderstood the question there. Yeah, I think it's fair to say we'll expect to launch in the second mid-2027. The impact will sort of evolve after that, and it'll take some time. But we do think it's based on our research, it is a tailwind for our IV business.
Got it. Appreciate it. Thank you very much.
Thanks, William.
Again, that is star one if you'd like to ask a question. We'll go next to Brian Cheng with JPMorgan.
Hey, guys. Thanks for taking our questions today. Earlier, you talked about how hospital growth has seen a lot of momentum here, specifically this month. Just curious if you can give us a better sense of what's driving it, and how should we think about that momentum going into the new year? Secondly, just on the simplified IV schedules, as you think about this being in place mid-year next year, how should we think about the potential impact of that on the continued commercial trajectory? Thank you.
Sure. Adam, you want to go ahead and talk about the growth in the hospital momentum?
Sure. Yeah, two parts to that, what's driving the continued growth here. I mean, as we highlighted in the call here, we believe the growing physician experience and the expanding body of clinical evidence and real-world data are building confidence in BRIUMVI. That's translating to more prescribers, more repeat prescribing, and increasing in the use of treatment, both in naive patients and patients switching from other therapies. So we're gaining here in expanding anti-CD20 market, so we're both growing share and we're benefiting from an expanded market. So both of those things are contributing to growth. Specifically in the hospital, we're seeing encouraging progress, with September and October being our strongest hospital months since launch. Hospitals have always represented an important opportunity for us, but in this segment, adoption involves more stakeholders and can take longer to develop.
Our teams are working across physicians and infusion staff institutional processes. We think the growing evidence is helping build confidence, and we are continuing with sustained effort and engagement, and that is helping to build confidence in the hospital segment. Also our DTC efforts are increasing patient awareness, and we think that helps as well. All those things are contributing to the growth that we are seeing. The second question was about, similar to, I think, what William Wood was asking on ENHANCE. We expect a mid-2027 approval. We think it is a tailwind to our business. Our market research suggests that it is an improvement in patient convenience, treatment center efficiency, and we think that will scale as we go, as we get the approval. It will take some time to implement, but we will start to see increased usage in the back end of 2027 and into 2028.
Great. Thank you.
We will hear next from Prakhar Agrawal with Cantor Fitzgerald.
Hi. Thank you for taking my questions, and congrats on the quarter as well from my side. Maybe firstly, if you can talk about the 340B exposure from BRIUMVI IV, and given the expected policy changes next year around 340B pricing, what could be the potential impact there on BRIUMVI? Secondly, on the subcu BRIUMVI, maybe just even qualitatively, how should we think about the uptake for that drug, and any reason to believe that the uptake for subcu will not be faster than the BRIUMVI IV franchise? Thank you so much.
Thanks for the question, Prakhar. Adam, maybe we want to start with the 340B exposure.
Yeah, sure. With the 340B policy, first of all, it's a policy that affects all buy-and-bill drugs, not just BRIUMVI. It specifically impacts Medicare patients at 340B hospitals, which is a small percentage of our business, maybe about 5%, as the vast majority of our business is commercial. Based on what we know today, we expect minimal impact. In fact, there could be some scenarios based on what hospitals do, where this could potentially be a positive for us. Then in terms of, you asked a question about subcu uptake, I think was the question. Mike, do you want to answer that, or do you want me to continue?
Yeah, I'll take a shot. You can go ahead. I mean, look--
Okay
--as we've said, we think it's a very large opportunity. We already have built a brand, we've built a team. We're pretty much set up to go. I think it's one of the, probably in all of biotech, one of the most straightforward new launches that one could think about for a company. Yeah, I mean, would we anticipate a more rapid uptake than we have for the IV? The answer, I think, short answer would be yes, qualitatively. Adam?
Yeah, agreed. I mean, we're building with a brand that already has strong physician awareness, growing patient awareness, existing commercial infrastructure. That gives us the opportunity to build on top of what we already built. So yeah, qualitatively, it should be.
Thank you.
Excellent. Thank you.
This now concludes our question and answer session. I would like to turn the floor back over to our CEO, Mike Weiss, for closing comments.
Great. Thank you, operator, and thanks everyone for joining us today. As you've heard, we're delivering on our commercial commitments, advancing important clinical programs, and building the financial strength to pursue even greater opportunities. Reaching a billion dollars in annual revenue is an important milestone, but I believe we're still early in stages of what TG can become. With continued growth in IV BRIUMVI, important potential launches ahead, and a pipeline that we believe can create an entirely new source of value, there's a lot to be excited about. I want to thank our team for their continued dedication, the physicians and patients who place their trust in us and BRIUMVI, and our shareholders for their ongoing support. We look forward to updating you on our progress, and thank you all. Have a great day.
Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.