TG Therapeutics, Inc. Aktie

Greetings. Welcome to TG Therapeutics Second Quarter Conference Call. [Operator Instructions] Please note this conference is being recorded. At this time, I'll turn the conference over to 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' Second 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 development, 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 would 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 products and 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 statement 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 will turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone. We appreciate you joining us. Second quarter of 2026 was another quarter of strong execution. More importantly, it marked an important evolution for TG Therapeutics. For the last several years, we've been singularly focused on one objective, establishing BRIUMVI as a leading therapy in relapsing multiple sclerosis. That remains our highest priority today and will remain so for years to come. But increasingly, BRIUMVI has enabled us to build something much bigger. It really represents the starting line for TG, the starting line for continued innovation from new formulations and new indications to novel therapeutic approaches to thoughtful business development and ultimately, for building an organization capable of repeatedly creating value for patients and shareholders.

The second quarter provided a window into where we're headed. From a commercial perspective, we delivered another excellent quarter, once again exceeding our guidance. New payors continue to grow, physician options expanded and our commercial organization continued to execute at an exceptionally high level. As we approach $1 billion of annualized run rate, we continue to believe we're still early in the life cycle of the BRIUMVI franchise. Our objective is straightforward, to become the #1 prescriber or anti-CD20 therapy in relapsing MS based on dynamic market share, and we're making meaningful progress toward that goal, not only by continued commercial execution, but also by ongoing product innovation and a growing body of real-world evidence demonstrating the BRIUMVI value proposition.

During the quarter, we announced positive top line Phase III results from our ENHANCE study, demonstrating that patients that initiate BRIUMVI with a single 600-milligram infusion, replacing the currently approved day 1 and day 15 initiation schedule. Based on feedback from health care providers, the ability to initiate BRIUMVI with a single infusion will be viewed very positively by both patient and infusion centers. Eliminating the need for an additional infusion visit reduces treatment burden and removes one of the barriers to switching from another anti-CD20 therapy to BRIUMVI. If all goes well, this new initiation schedule could be available as early as the middle of next year.

We also reported additional real-world data from our ongoing enabled Phase IV study, demonstrating significant and durable improvements in patient-reported outcomes on BRIUMVI. Importantly, patients transitioning from prior anti-CD20 therapies maintain strong disease control while also reporting meaningful improvements in convenience, tolerability and overall treatment satisfaction. While we continue to strengthen our position within the IV anti-CD20 market, we also made significant progress during the quarter, advancing subcutaneous ublituximab, the active agent in BRIUMVI. We reported positive Phase I bioavailability data for our proprietary subcutaneous formulation increasing our confidence in the quarterly dosing schedule that is being evaluated in our fully enrolled Phase III study.

We're expecting top line Phase III results around year-end or early next year. And to be clear, subcutaneous BRIUMVI is not simply another formulation, it has the potential to materially expand the reach of the franchise. Today, we participate in the physician administered segment representing approximately 60% to 65% of the overall anti-CD20 market. A successful subcu BRIUMVI will allow us to compete for patients who choose a self-administered therapy, giving us the opportunity to participate across the entire anti-CD20 landscape for RMS.

When pricing dynamics are considered, the subcu opportunity has the potential to more than double BRIUMVI's current addressable market. And when you combine the strength we're already seeing in the IV franchise with the potential to have a best-in-class subcutaneous product, we continue to believe the long-term opportunity for the BRIUMVI franchise is substantially greater than many appreciate today. Beyond MS, we've begun extending the reach of BRIUMVI into additional autoimmune mediated diseases. During the quarter, we announced encouraging preliminary Phase I data in patients with myasthenia gravis and initiated what we believe could be a registration-directed Phase II study. There are now multiple treatment options available for MG, but our approach combining the rapid symptomatic relief of FcRn inhibition with the possibility for durable disease control with BRIUMVI has the potential to represent a meaningful treatment advance by reducing the long-term treatment burden of FcRn inhibition and optimizing disease control.

We also initiated a Phase II study in treatment-resistant schizophrenia. Growing evidence suggests that a subset of treatment-resistant patients may have an underlying autoimmune component to their disease. Our study is designed not only to evaluate clinical outcomes but also to better characterize that biology through biomarker analysis. The current investment is modest, but the potential upside if the biology proves correct, could be significant. And we continue to evaluate additional opportunities to expand BRIUMVI.

Finally, I'd like to discuss azer-cel, our allogeneic CD19 CAR-T program. We continue to make encouraging progress. We have now enrolled more than 20 patients, primarily with progressive forms of multiple sclerosis and recently expanded the study to include additional dated diseases. While we're focused on generating rigorous clinical evidence before drawing conclusions, we've been encouraged by the continued enthusiasm from investigators, strong patient interest and the anecdotal reports emerging from some study participants. We're looking forward to sharing a clinical update during the second half of the year.

When I step back and look at everything we accomplished during the quarter, continued commercial execution, positive ENHANCE data, growing real-world evidence from ENABLE, encouraging progress with subcu, expansion into MG and schizophrenia and continued advancement of azer-cel, I see a strategy coming to life. One successful product becoming a durable engine for innovation. Our goal isn't simply to build a great product, it's to build an organization that repeatedly creates great products for patients and great opportunities for our shareholders.

Before turning the call over to Adam, let me briefly touch on our capital allocation. Our philosophy remains unchanged. We will continue to invest where we believe we can create the greatest long-term value. That means, first and foremost, investing behind BRIUMVI and our commercial efforts, also advancing our pipeline and pursuing strategic business development opportunities that strengthen our long-term vision and generate attractive returns as well as when appropriate, continuing to repurchase our own shares. Every capital allocation decision begins at the same question, where can we create the greatest value per dollar invested. That discipline has served us well and will continue to guide us.

With that, I'll turn the call over to Adam Waldman, our Chief Commercial Officer. Adam, please go ahead.

Thanks, Mike, and good morning, everyone. I'm delighted to provide a commercial update. Performance was once again very strong. Second quarter was another record quarter of new patient starts, which surpassed our prior record seen in the first quarter. Persistence continues to exceed our expectations. We're adding new prescribers, repeat prescribers continue to increase. And importantly, an increasing percentage of patients are beginning their treatment journey with BRIUMVI rather than switching to us later. .

We highlighted that trend last quarter as one of the strongest leading indicators of long-term franchise strength. The second quarter reinforced that view. When you combine a growing installed base, record new patient demand, strong persistence and expanding physician adoption, you create a business that becomes more durable and more predictable over time and that's exactly what we're seeing in our business today with another excellent quarter. We generated approximately $228 million in U.S. BRIUMVI net product revenue with global revenue exceeding $250 million, once again exceeding our guidance.

In the U.S., that represented quarter-over-quarter growth of approximately 17% and year-over-year growth of more than 64%. Based on the rest of the business, we're raising our full year U.S. BRIUMVI net revenue guidance to $890 million to $905 million and now expect approximately $950 million in total global revenue for 2026. Looking to the balance of the year, we expect the fourth quarter to drive second half growth, positioning us to exit 2026 with quarterly U.S. net revenue exceeding $250 million, our first $1 billion annualized revenue run rate and setting the stage for our first $1 billion plus U.S. BRIUMVI revenue year in 2027.

Building a blockbuster brand in less than 4 years doesn't happen by accident, it's the result of disciplined execution and relentless focus on the fundamentals that matter most. Over the past several years, we've built a commercial platform designed not simply to launch a product, but to support a long-duration franchise. Our field organization, market access capabilities, patient support services and direct-to-consumer investments continue to make BRIUMVI easier to prescribe, easier to access and easy to remain on.

We've also been encouraged by the early response to our direct-to-consumer campaign and plan to expand those efforts during the second half of the year. We believe increasing patient awareness complements the commercial infrastructure we've built and represents another important driver of long-term growth. As the business continues to grow, we're able to leverage that commercial platform across an expanding franchise, creating increasing operating leverage over time. Looking ahead, we see 2 important opportunities to build on our MS franchise. The first is the new simplified IV initiation schedule supported by the positive ENHANCE Phase III results. If approved, initiating patients with a 600-milligram infusion, further enhances an already strong IV offering. And we believe it will fuel additional share gains within the IV marketplace.

It reduces complexity for physicians, for infusion centers and most importantly, for patients. The second opportunity is subcu BRIUMVI. Today, approximately 35% to 40% of the dynamic anti-CD20 market consists of patients receiving self-administered therapy, a segment where we don't currently participate. A successful subcu BRIUMVI program would allow us to compete directly in that segment with what we believe could be a highly differentiated product. But the more important point is how we think about these opportunities together. While they are 2 products, they will represent one franchise powered by the trusted efficacy and safety profile of BRIUMVI that ACPs have already prescribed to more than 30,000 patients globally today.

Our goal isn't to ask physicians or patients to choose between IV and subcu. Our goal would be to ensure whichever route of administration best fits an individual patients need, there's a compelling BRIUMVI option. That allows us to compete across the entire anti-CD20 RMS market with a single trusted brand, supported by one commercial organization, one reimbursement infrastructure, one patient support platform and one field team. That's powerful. And it's another example of how the operating leverage of this business continues to improve over time. When you step back and consider the size of the IV market, the portion of the market will be able to access the subcu, the trajectory we're seeing today and the commercial infrastructure we've already built, it's easy to see why the long-term opportunity for the BRIUMVI franchise is substantially larger than where it sits today and reinforces the confidence that BRIUMVI has the potential to become the leading therapeutic in this category over time.

We're building that opportunity on top of a patent estate extending into the 2040s. That gives us confidence to continue investing in the brand, investing in life cycle innovation and investing in the commercial platform because we believe those investments will continue generating value for many years to come. So when I look at the business today, I don't see just another strong quarter. I see a commercial franchise that's becoming stronger, expanding its patient base, deepening physician adoption, demonstrating strong persistence and creating increasing operating leverage. That's why we remain confident that we're still in the early innings of realizing BRIUMVI's full potential.

With that, I'll turn the call over to Sean.

Thanks, Adam. A lot of what you just heard from Mike and Adam shows up in the financials. Let me take you through the details. U.S. net product revenue in Q2 was approximately $228 million, up 64% versus the same quarter last year. Total net product revenue was $236 million when including product sales to our ex-U.S. partner. Adding $4.5 million of license, royalty and other revenue and total revenue for the quarter was $240 million. In terms of margins, the gross margin of our U.S. business remains remarkably consistent and predictable at approximately 87%.

When factoring in sales to our ex-U.S. partner and other revenue sources, total gross margin landed at 83% for the quarter, in line with our expectations. On the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based compensation, was approximately $150 million for the quarter, including roughly $55 million of charges associated with subcutaneous and secondary source manufacturing activities. Excluding those, underlying OpEx was about $95 million, consistent with our expectations and down from Q1. As a reminder, our 2026 OpEx projections include approximately $100 million for these manufacturing activities. We call those costs out separately because they are expensed through R&D as incurred. And while not all of it converts to saleable inventory, a meaningful portion does, which would represent a gross margin tailwind in future periods if the programs are successful.

The result was operating income of $21.7 million for the quarter and net income of $7.8 million or $0.05 per diluted share. Excluding the manufacturing charges I referenced earlier, operating income would have been approximately $76 million, a meaningful step up from both Q1 and the prior year period. On the same basis, net income comes to approximately $62 million, and that's the number we'd point you to as the better reflection of our underlying earnings power. Turning to the balance sheet. We ended the quarter with approximately $612 million in cash, cash equivalents and investment securities.

On revenue guidance, U.S. BRIUMVI net revenue through the first half was approximately $423 million, on track for our full year target of $890 million to $905 million. Total revenue of approximately $445 million puts us equally well positioned against our $950 million full year global target. In terms of expenses, we expect full year OpEx of $350 million to $400 million, excluding stock-based compensation, reflecting continued investment in our commercial organization and expanded DTC efforts.

On top of that, we expect approximately $100 million for the manufacturing-related expenses I referenced earlier. All in, it was another strong quarter financially. And as Mike and Adam have laid out, we believe the best is still ahead of us.

With that, I'll now turn the call back over to the conference operator to begin the Q&A.

[Operator Instructions] And the first question today comes from the line of Tara Bancroft with TD Cowen.

This is Greg Torres on for Tara. So as you evaluate the long-term opportunity for subcu BRIUMVI, how different are your peak sales of some under a quarterly dosing regimen versus a more frequent every 2-month regimen?

Thanks for the question. Adam, do you want to take that one?

Yes. I mean we haven't given -- thanks for the question, Greg. We haven't given specific guidance on that in terms of revenue. But in general, we do think a less frequent dose is going to be better than a more frequent dose. .

The next question from the line of Prakhar Agrawal with Cantor Fitzgerald.

Maybe firstly, on the subcu BRIUMVI. Since this will be a Part D product, just curious how you'll approach the pricing here and contracting compared to -- since you could have a quarterly regimen here? And any sort of initial comments on what do you think the uptake will be given the brand familiarity here? And maybe just a little clarification on the OpEx increase, if you can elaborate on how much of that is driven by R&D given some of the pipeline investments versus SG&A? And then a clarification on the BRIUMVI sales that you provide to Neuraxpharm ex U.S. seems like a meaningful increase and $25 million for the -- are there some one-offs here to Neuraxpharm for this year for ex U.S. buildup? Or are you expecting more meaningful royalty contribution from ex U.S. given this increase in ex U.S. supply? And just to clarify, if the sales to Neuraxpharm is done at a cost plus a markup on the revenue line item.

Prakhar, thank you for that 5-part question. We'll try to break that down. Adam, do you want to start us up with some thoughts on subcu Part D pricing and contracting and potential uptake.

Sure. Yes. Thanks for the question, Prakhar. On the subcu side, we're not going to talk about pricing yet. We still got a little bit of time here, and we'll do the work that we need to do. But we do think we can price it competitively in the market, and we'll take into account all the different factors you need to take into account. As far as uptake, we feel really good about the profile of the drug. We think the uptake will be strong. We continue to do market research, and we'll continue to do more as we get closer to launch here, but the profile that we have in mind, we think we'll do quite well in this space.

Yes. I'll just layer on top of that. Adam and the team are to do proper market research. I do my own work when I go out in the field. I've been out in the field, probably 6 or 7 days in the last 21 days, meeting with clinicians at primarily academic, large academic centers. And I can tell you the enthusiasm and excitement for the subcu product is pretty incredible, actually, pretty impressive. Particularly, it's really interesting, there's -- most of the people have heard about what we're doing. So the pretty educated teams have been out there. They see the data online and wherever.

But people who haven't yet realized that we're targeting a quarterly product that's in an auto-injector, their eyes light up. They've -- I think everyone is somehow thinking that you can't do this kind of thing with taking an IV to a subcu, and it's really interesting to see how excited they get. So like I said, Adam's doing the market research on the uptake properly, but I can tell you anecdotally in the field when I talk to folks, they're pretty enthusiastic about it.

And I'll lay on top of that, they're also super excited about the enhancements through the consolidated dosing. I think that's something that's also going to be pretty interesting in how that impacts the uptake next year. The part 2 of your question, OpEx drivers, slightly guidance, a little higher on the OpEx for the year. Sean, you want to take a crack at the distribution there, R&D, SG&A. And Prakhar, to your point, yes, we've extended R&D, but we're also -- I'll layer in and then Sean, you can add a top. We've also -- Adam's team has done a really nice job piloting some DTC campaigns. And I think we're going to lean into some of that, both on the commercial side, but also online. So I think you'll see some of that showing up. But Sean, maybe what else can you add to that?

Yes. I think you covered it on the SG&A side, Mike, and of course, Prakhar, as you know, we call out the $100 million in subcutaneous manufacturing, secondary source manufacturing costs as well. So we factored that into overall guidance as well. But I think the combination of those 2 things did cover it. I think your last question was on NXP ex U.S. revenue for the rest of the year. So we do model in some continued product revenue, as you noted, that we've seen throughout the first half of the year. And there is some other, of course, license and milestone related revenue that we model in for the remainder of the year, which drives that overall global revenue guide. .

Yes, I'll just layer on top. They are moving along pretty well on driving revenues. And so royalties are picking up a bit. But yes, in the second half, it's probably more related to milestones and other payments at the lowest. .

Our next questions are from the line of Michael DiFiore with Evercore ISI.

Two for me. Roche recently said that anti-CD20 competition was running above expectations and moved OCREVUS growth to the end of its range or the low end of its range. Are you seeing acceleration in BRIUMVI's share gains? And is that coming more from OCREVUS switches or treatment-naive starts? And my second question is related to the schizophrenia study. What result would you consider strong enough to justify a larger randomized study? And yes, I'll just leave it there.

Sure. Thanks. Adam, maybe you can take the Roche anti-CD20 competitive issues that they're facing in the marketplace, which I assume was referring to us, which is interesting because people, I guess, didn't really think we could compete with Roche, but apparently, they do believe so. Adam, do you want to take that, and I'll take the schizo question second.

Sure. Yes. Thanks for the question. Listen, we've -- this is certainly a competitive market space, and we've competed alongside the new product from a new formulation from Roche for several quarters, and we continue to grow our new patient business, 2 record quarters in a row. So we continue to grow through the increased competition. And in terms of your question of where we're seeing it, we're seeing it from both switches from OCREVUS and treatment-naive patients.

And as I mentioned in our prepared remarks, I think the growth in naive patients reflects increasing physicians' confidence the brand and starting with BRIUMVI, which we see as a really important indicator of long-term share growth and confidence in the brand. And then importantly, from switching from OCREVUS, we do know they're encouraging switches from their IV version to their subcu version. But despite that, we're still continuing to see strength in patients switching over to -- from OCREVUS to BRIUMVI. And we do see, I think, a lot of their business is coming from that switching as opposed to coming from BRIUMVI itself.

Yes. Thank you, Adam, for that. I appreciate that. In terms of schizophrenia and the results that we would like to see to move on to Phase III. So Michael, the study is designed, and we took a page out of our old oncology playbook. So it's designed as a Fleming 2-stage design. So you basically assume that there's a certain placebo rate that we've derived from the literature and that a good drug would have a certain rate of response, a past response. And we compare those 2 in 2 steps to see if you can sort of reach the hurdle.

If we reach the hurdle rate of responders, again, as it's designed to set up against a historical placebo rate. You've got to get above a certain hurdle, then I think we'd be pretty confident to move forward. If we're below that, obviously, we'll look at the data and see, again, this is where biomarkers might come in to be helpful. And if the biomarkers are saying there's a subgroup that makes more sense, we could then probably more likely rerun the smaller kind of study, that Fleming 2-stage design on that and confirm that, that is predictive or not.

But at the end of the day, this is a design that can move very quickly, give us some really robust preliminary information and give us an opportunity to move forward. So we'll keep you posted. But the idea is we'll get the response rate that we're expecting from the broader population that we're studying. We'll use -- again, we're doing the bio analysis to check and see what else is possible and what we can learn from it. But the main driver is going to be the response rate that we get.

The next question is from the line of Emily Bodnar with H.C. Wainwright.

I guess 2 for me as well. It looks like in the second quarter, a majority of growth in the MS market is kind of coming from the subcutaneous side. So I'm curious as you kind of advance and eventually commercialized BRIUMVI-based subcutaneous, how you see the IV market growing past that point? And then secondly, you mentioned you started some new indications for the azer-cel trial besides MS. Can you clarify which those are.

Sure. Adam, you want to talk about subcu growth over time and how that impacts IV growth in the future.

Sure. I mean, look, we -- our plan is to give people a choice given we'll have an option in both markets. We believe these are fundamentally 2 different markets, a physician-administered market and a self-administered market. And today, we compete in the IV space, and the subcu will provide us the opportunity to expand into the self-administered market. So -- and that will substantially increase our market.

Strategically, we think about it as one BRIUMVI franchise. And I think different patients will have different preferences for route of administration. But our objective is to have a compelling BRIUMVI option regardless of which approach best fits in individual patients, which allows us, obviously, to compete across the entire RMS space with one trusted brand win and all the things that I said. And we think that's a significant competitive advantage for the franchise overall.

Yes. I'll put an exclamation point on that. I mean we are fully committed to supporting our IV brand as we move forward. Creating a subcu is about patient empowerment, patient choice. We want to show up where the patients want to be, and we want to make sure everyone has a BRIUMVI option. But we don't know exactly where the market is going over time. The subcu distribution does oscillate quarter-to-quarter. Sometimes it's 30%, sometimes it's is 35%. And we don't know if it's going to break out and become something different over time. But either way, we want to be prepared to make sure that patients have a choice. As for your azer-cel question, we expanded the study into relapsing MS, MG, CIDP and NMO. .

The next question is from the line of Brian Cheng with JPMorgan.

Congrats on the quarter. Maybe just first, can you give us a bit more color around your updated U.S. net product revenue guidance? How is the raise reflective of your latest thinking of the IV uptick for the rest of the year? And then secondly, on MG, be great to hear how you're thinking about the opportunity here based on the post-Asgard induction setting that you're aiming for in the trial? What are some of the patient characteristics that you expect to capture in the study that may ultimately differentiates from other historical MG trials? .

Thank you. Adam, do you want to take a crack at the first part of that question on the guidance.

Sure. Yes. First of all, we're excited about the second half of the year and then raising our annual guidance again for the second time this year. So that's great. I think the best way to think about it, about the second half is exactly how we outlined it in our prepared remarks. We continue to expect the fourth quarter to be the driver of the second half growth. And again, we've raised the annual guidance here based on the strength of what we've seen in the first half with the fundamentals that we're seeing good progress in, record new patient starts, excellent persistence and continued physician expansion. All of that is giving us the confidence to raise here, and we feel good about the full year trajectory.

Yes. And then again, I'll just put an exclamation point on that. I think during the course of the year, we've already raised our guidance somewhere in the order of $75-plus million. So we're going to continue to drive, and we looking forward to our end of year coming out of the exit velocity of $1 billion run rate, which we think is pretty impressive. And I know Adam discussed it in his script, so I won't say more about that.

On the MG and how we're thinking about it, MG is becoming a better served marketplace. But if you look at how the treatments are delivered today, it's -- look, my words, maybe not others, but it's a little clunky. You basically put a person into a really good symptomatic place relatively quickly using FcRn inhibition. And then you wait and let the symptoms come back and then you treat again. And it's a pretty intensive program. I mean it's not the worst schedule once a week or every other week or whatever they're doing and they're improving upon. But it's still a little -- definitely a treatment burden involved with that.

The idea here is we can leverage that kind of rapid symptomatic relief of FcRn inhibition and hopefully layer in the long-term durability of response with something like BRIUMVI. And you put the 2 pieces together, and hopefully, you have a treatment that is really tailor-made for this kind of a population, get them into a symptomatic remission quickly, keep them there by using BRIUMVI, whether it's every 6 months or quarterly. I think quarterly will be a really nice option for patients to be able to do it at home and really would simplify, I believe, the treatment burden. So yes, we think there's room for improvement. And any time there's your improvement, there's an opportunity.

The next question is from the line of William Wood with B. Riley Securities.

Congrats on a very nice quarter. When we're thinking about sort of the second half and the year-end guidance, your fourth quarter or your $1 billion exit runway implies a fourth quarter of around $250 million, which leaves third quarter relatively flat. So how should we think about what may be driving that third quarter decrease or flatness maybe seasonality or gross to net or potential channel changes? And then coming away from fourth quarter and looking towards potentially into 2027, how should we think about the growth trajectory into 2027? And how do we start to think about the more meaningful focus of, I guess, TG a little bit more broadly, is it BRIUMVI IV? Or is this sort of the addition of the subcu coming to market.

Yes. I'll lead off with the second half of that question. I'll let Adam take some part of that first question. But obviously, we haven't given guidance yet for 2027. So we'll do that hopefully early next year as we've done in past years. But we're certainly feeling good about where we're heading. And in terms of the overall franchise, look, we think that we have multiple pieces that will continue to drive growth. We've got next year, ideally, we'll have ENHANCE with the consolidated dosing, which should hopefully give us another growth expansion. And then sub-cus in order of magnitude change. We're talking about something that is upsize, comparable towards the current market, if not larger than the current market that we're currently serving.

And the current market we're serving, we're not even close in our belief to full saturation of our market share. So '27, I think, is going to be a really exciting year for us. Like I said, with the launch, hopefully, sometime in the middle of the year, we could see some really interesting share gains. And then once we get into '28 subcu, it's a whole another ball game. So I think we're not there yet to give any guidance for 2027, but I think we're in a great place leading into that. Adam, any thoughts on Q3, Q4 dynamics?

Sure. Yes. I mean, listen, we've talked about this before on the call. And certainly, as we move across the year, each quarter has some unique dynamics with Q3 having some seasonal dynamics at play, not just for BRIUMVI, but the entire MS market. It's simply too early in the quarter to know exactly how it would land. I think what we have better visibility and confidence is the is the second half in aggregate, and that's why we felt comfortable raising the full year guidance. How exactly it plays out between quarters is not much of our concern -- we don't concern ourselves too much about it. We're just -- we're more focused on full year guidance. And as I said, I think the best way to think about the second half is how we outlined it, where we continue to expect fourth quarter to be the driver of the second half growth.

The next question is from the line of Cha Cha Yang with Jefferies.

This is Cha Cha on for Roger. Congrats on another great quarter. I have 2 questions here from us. One is whether you can speak more to your plans for your DTC campaign expansion and what we can expect to see from that going forward? And then two is, you talked about persistence being longer than you expected, whether you can talk more about what's driving that.

Sure. Adam, I think this is all you. Go ahead.

Yes, sure. Thanks for the question, Cha Cha. As I said in my remarks, I think the response to what we have done so far in the DTC arena has been positive. All the leading indicators have been trending in the right direction, gives us confidence to expand it here. You can expect more of an omnichannel presence across digital, linear television, connected television, social channels and sort of putting a full complement of assets in the market. And again, we're excited about it and the leading indicators so far give us the confidence to continue to do that.

And then as far as your question on persistence, yes, I mean, we continue to see really good persistence here and continues to be better than what we've expected. We think that these patterns are basically driven that when patients do well, they stay on therapy. So we think it's a sign of confidence in BRIUMVI, and we'll continue to track it. We're still relatively early in the life cycle of this brand. But so far, we're very encouraged by the persistence trends that we continue to see.

Our next question is from the line of Prakhar Agrawal with Cantor Fitzgerald.

I had a lot of questions this quarter, Mike. Firstly, on gross to net, if you can just comment on the gross to net for the quarter. I think you have previously said 65%. So how did it track relative to your expectation? And how should we think about gross to net for the rest of the year? And secondly, we are seeing some consolidation happening in the mid-cap biotech space. You have predictability around cash flows, especially meaningful cash flow starting next year. What's the appetite for doing something meaningful on the BD front? Or are you looking at more opportunities more on the earlier side.

Thanks, Prakhar. Adam or Sean, do you want to talk about GTM for the remainder of the year.

Sure. Yes, gross to net is basically unchanged from what we said. We predicted it to be in the mid-60s and that prediction is still accurate. .

And more on the biz dev side, strategic side, Prakhar, our goal is always to maximize shareholder value. As I said in our discussion on capital allocation, we continue to ask the question every day, what is the best use of our money, how can we best invest it? To me, obviously, it's an interesting part of the business. It's -- from my prior years as a hedge fund manager, I get to really think about the best way to create value for shareholders. As everyone knows, I'm probably the largest single shareholder. So I do care about how we spend our money and how we invest it. And yes, I think we're building a company that we do think has predictable cash flow and growing and will be growing for quite some time, and we have patents out to the mid-2040s.

So I think the durability of this franchise is far beyond what most people, I think, on the sell side are modeling today, and I think that probably should be adjusted. All that's a long way of saying we're going to continue to build a company that creates shareholder value. We're going to continue to look for opportunities out there. We're not looking for any major consolidation plays. I think we continue to look for -- on our side, on the inbound side, we look for things that will create value without stressing our bank accounts. We think that there are a lot of interesting single assets or potentially even small companies, but mostly single assets that we can add to the company.

One of the things we would like to think about is wherever BRIUMVI can go next and azer-cel can follow, we'd like to think about what other pieces we could put together in those areas. So as we continue to build out into some of these new therapeutic indications, the lead always be around where can BRIUMVI work, where can azer-cel work because there'll be a lot of overlap between those 2? And then are there other mechanisms of action within those therapeutic areas that could be applied to satisfy the needs of that patient population.

So that's I think we're thinking about it. But again, our goal is always to create and maximize long-term shareholder value. We understand that when we do that, we, of course, will create the most opportunities for us and our shareholders. .

At this time, we've reached the end of our question-and-answer session. I'll hand the floor back to Mike Weiss for closing comments.

Great. Thank you, and thanks, everyone, for joining us. Just a quick summary on the 2Q progress. I think we did -- we really had another really strong quarter. We generated positive Phase III data from the ENHANCE trial. We advanced our subcu BRIUMVI toward a pivotal readout later this year or early next. We expanded BRIUMVI into autoimmunity-mediated diseases. We continue to advance azer-cel. And as you heard from Adam, we raised our guidance to $890 million to $905 million just in the U.S. alone and globally approaching $950 million.

We continue to see BRIUMVI as a multibillion-dollar franchise making. I can't emphasize that enough. Creating value for our shareholders is our top priority. And BRIUMVI, as we said, becomes really the beginning of what we're working on to create value, becomes the lead of everything that we focus on. And finally, I just want to thank our shareholders for their continued support, our employees for their commitment to our mission and the patients, of course, who we serve and the health care professionals continue to place their trust in us. We take that really seriously. So thanks again for that. And thank you all for joining us. Have a great day.

This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation.

Good afternoon, everyone. Thanks for joining us here at the Goldman Sachs Global Healthcare Conference, including everyone joining us virtually. Thrilled to have on stage with us today the Chief Executive Officer of TG Therapeutics, Mike Weiss.

And maybe we'll just turn it to you to start with kind of an overview of the business, key priorities over the intermediate term. And I've been asking everyone how do you think about the core competencies of your business?

Sure. And thanks for having us. Always delighted to be in lovely, Miami. So at TG, we try to keep things relatively simple. We've got our BRIUMVI now approved for relapsing forms of MS. We're about 3.5 years-ish into the launch. Our target this year, I think we're at $885 million to $900 million in terms of revenue guidance for the U.S. alone. And in terms of key priorities for the year, one is obviously continued commercial execution. That takes up a good portion of what we focus on care about. We've had a few interesting readouts recently. So we have our ENHANCE study read out recently positively. That hopefully will lead to a label change in 2027 to simplify the onboarding. We'll talk about that, I'm sure at some point, but day 1, day 15 combination on day 1 simplifies the onboarding on to BRIUMVI.

And then we also had some positive data around our subcu program. I'm sure we'll end up talking more about that. So I won't tell you too much, but hopefully, that will lead to a new product line for us in subcu in 2028. And today, we announced a small cohort of patients with MG and the start of a Phase II potentially registration-focused study in MG. So I think it's continue to execute on our plans to get the label update for ENHANCE '27, get to the subcu in '28 to carry through on the MG study, while we, of course, just back to commercial execution.

We'll get to the MS thing, but just it's breaking news, I would love for you to spend a little bit more time on the MG data that you released today and kind of how it sets up a registration -- potentially registrational Phase II program?

Yes. So we're excited, MG is something we've been thinking about for quite some time. We were able to get a small cohort of 11 patients into the Phase I subcu study. So that was really a nice addition for us. The data looked, I think, great, as great as you can get for 11 patients to put it into context, and we're not talking about hundreds of patients. But I think it was just confirmation of effect, which we expected, right? It's no surprise that CD20s would work in a cohort of MG patients. So I think that was confirmation enough for us to move forward, both the historical usage of CD20s and this agent, particularly, which we think is differentiated. So the 11 patients look quite good. On top of that, we came up with, I think, a creative study design to sort of meet a need in the MG marketplace. It's become a little crowded with FcRn and complement inhibitors, which is great for patients. But every time you add new therapies, you end up opening up new opportunities.

And so we took advantage of the new opportunities. The FcRns are dosed weekly and then intermittently and patients will go through these cycles of having very good responses on their symptom scores. And then you don't treat them and their symptoms come back. And then you treat them again, you bring them back down on their symptoms and then they come back. And so this episodic treatment, one is can imagine it's great for patients to have to continually go back and forth with their disease. And then when they are treated, they're treated on a weekly basis. We think BRIUMVI could have the ability to maintain those really deep clinical benefit and just keep it there. So you don't have to continually go back and get retreated.

So you're mentioning the kind of unmet need that you see in MG despite the competitive landscape. I guess how are you designing the Phase II study to make sure that you can prove out that it meets that unmet need?

Yes. So the way the study is designed is that all individuals will basically go through the 4-week run-in for...

[indiscernible] a month...

If you could say it, God bless, I can't really say the whole name, but efgart for short. They'll go through the standard 4-week. And we expect about 70% of those patients, maybe 75% of those patients will get a really nice response from that. And then right after that, we start the standard dosing of BRIUMVI. We're using it experimentally for the moment, the standard approved dosing. But as you know, from our subcu stuff, we'll be able to use subcu assuming we're successful, somewhat interchangeably, so we can then swap it out. I think the ultimate goal is to have the product profile be a subcu quarterly for that indication.

So every patient will then -- in theory, patients that got the benefit will be down on their symptoms. We then treat the patient at that point. And the goal is to maintain those patients at that level of benefit. Perhaps we'll see some additional benefit, that would be great. And then the patients on placebo infusion, their natural course is to return to baseline at some point, whether it's 8, 10, 12, 14 weeks, one would anticipate they would return to baseline. And so it's basically -- you can look at it as almost a Kaplan-Meier curve, right? It's going to be like a time-to-event analysis. And we think we have a really good chance of maintaining those patients.

And have you spoken with regulators and got alignment on the trial design? Or like where are you in that process?

So from a registration standpoint, when you're using a Phase II trial, there's really no alignment for regulatory purposes. I mean, obviously, an IND, it's a U.S. study, the FDA has looked at the trial. But in terms of whether it's registrationable is a later discussion. And it's going to be data dependent for sure and then obviously, always becomes a review issue for sure.

Okay. Maybe we can turn back to the commercial execution. And like you mentioned, BRIUMVI launch now in its fourth year guidance, $885 million to $900 million. I guess what are the key considerations? And how do you think about formulating that guidance? And then kind of from there, what do you think of as potential drivers of upside or within that range?

Yes. So the nice part about the BRIUMVI business at this moment is we do get a lot of repeat business, right? This is a business where patients will continue, hopefully, to come back. I think we've always modeled and we maybe talk about this, we've always modeled in about a median of 5-year for treatment course. So there's a pretty large accumulation effect. So when we start a new year at the beginning of that year, we have a pretty good sense of what the base business looks like based on our expected persistence. And then the key variable on top of that is, one, do we continue to see that persistence, right, that will change.

And then the new business that comes in every year. And if you look at something like ocrelizumab, the vast majority of their business is accumulated business, right? It has to be, right? There's not -- I mean, you've got approximately -- I think it's 80,000 patients will seek a new treatment every year. So it's the dynamic share. About half of them will go on to a CD20. And then obviously, within the CD20 class now, there's 3 agents, and it's relatively competitive for those 40,000 potential patients. And so when you think about -- I think ocrelizumab probably has 100,000 to 125,000 people on their portion of the new market is going to be a fraction of the total.

So again, the key -- the 2 keys will always be, at this point, persistence. Are we seeing the same or better persistence than we expected as we go into the year for the patients who have already been treated and then our market share gains.

So as you think about kind of the portion of sales that are derived from patients who are staying on therapy versus patients that are new to therapy, where do you stand today in terms of the portion of sales that come from patients already on drug? And where does that get to over steady state?

Yes. So I don't have the exact percentage, but I do think if you look at something like ocrelizumab, my guess is at this point in the maturity now we're capturing market share. So -- but at the point in which you don't capture any more market share, my guess is it's an 80-20 split, give or take, the base business to the new dynamic business.

Okay. So speaking on that market share piece, I guess, what can you share in terms of the share of the switch patients or the newly diagnosed patients, that 80,000 dynamic population that you talked about?

Yes. So that 80 again, goes down to 40 of the dynamic share for CD20 class. And within that class, I mean, when we said something publicly, we said we were approaching about 1/3 of the IV business, which translates to about 20% of the overall business. That market share has been growing. We haven't updated the number with precision. And some of the precision is somewhat challenging because the quarter-to-quarter, the dynamic share does change. It's not a linear 10,000 per quarter for the year of the 40,000. So it's not linear. But within that context, we did say that the first quarter of '26 was our best enrollment quarter ever, and I'm highly confident that we'll see another record quarter in 2Q.

Great. In terms of the kind of revenue trajectory from here, 2027 consensus is north of $1 billion, so blockbuster status in year 5. But you've said that the peak opportunity is still multiples from where we are today. Can you be more specific about kind of how you're thinking through the peak opportunity and in particular as well, the path to getting to peak, like how long will it take?

Yes. So not so long as short. I mean we will be at -- our projections are that we'll be at a run rate -- $1 billion run rate before the end of the fourth year of a little bit faster. But yes, I mean...

Run rate versus full year. We're on the same page.

We're on the same page. Yes. So we are on the same page and obviously comfortable with those numbers where we stand. Of course, if we end the year with a run rate beyond $1 billion, we certainly think next year is north of $1 billion in sales. We haven't given any obviously specific guidance. But what we have said, and I think you're alluding to is in our last conference call, when I talked about the IV business alone, I said I thought we were years and multiples away from peak, just of the IV business alone. And so with IV business tracking toward $885 million to $900 million, multiples of that in years away, again, -- it's -- I don't have the exact year, but I could tell you that it's not anytime soon, which is a good thing.

But it will be approximately 5 years after we stop taking market share, right? So when the dynamic share flattens out, and I'll just pick any number. Let's say, at some point, we are 50% of the IV dynamic share business and so for IV business -- once we hit that point, if we don't keep growing it, holding aside the fact that probably the overall market is growing. But putting that aside, just holding constant, the entire market is not changing. At the moment, we hit our peak market share, we're probably 5 years of accumulation away from steady state, right? So that would be peak. So that doesn't include, obviously, where we are with IV, but -- so that's the -- I mean, with subcu. So that's the IV portion of the market. So I do think we are multiples away from the peak and years away in that context. And I believe that we will continue to gain market share over the next 3 to 5 -- minimum 3 to 5 years and probably longer.

Okay. Great. You mentioned at the top that you have a few more kind of convenient dosing strategies in the works, including the enhanced profile as well as the subcutaneous product. So why do you think it's important to have these offerings to physicians and patients? And what do you expect that to drive in terms of share gains?

Yes. So it is important to focus on the patient and the experience. I think like Maslow's 5 stages of realization, right? First...

That's a hierarchy of needs.

Thank you. Yes. So at the beginning, you just got to make sure you've got food and shelter, right? And that's, of course, if you think about it in the treatment landscape, you just want to give something -- someone something that helps them. And then you want to improve upon how it helps them, but you also just want to make it easier for them to enjoy their lives. right? So the more we can optimize the process for what we believe is a best-in-class drug, the easier it is for folks to enjoy the benefits of it. So removing the day 15 dose to, I would say, somewhat to our surprise. We continue to hear really positive feedback from both patients and from clinicians and centers. So yes, we just think it's important to continue to think about the patient experience in the journey.

Maybe we can talk a little bit more about the subcutaneous product because you did just have bioavailability data last week. I guess, again, on that question, what is the role that you see subcutaneous offering playing in the market? Why do you think it was important for you guys to participate there?

Yes. So the market for CD20, as I talk about those 40,000-ish patients, and that is growing. It's not linear growth. Some quarters it's a little lower because I said, it's not -- every quarter is not the same, but the trend line is growing. So there are more patients in that 40 that will continue to come into the system, but it's just easier to keep that constant. So of those patients, one of the threshold questions after a clinician speaks to -- decides that they want the patient on a CD20 is, do you want to self-inject or would you like us to do it for you? About 35% to 40% of patients are choosing to do it themselves. If they choose to do it themselves, we don't have a product that can compete in that marketplace today.

So we're not talking about some sort of brand extension. This is literally a new almost -- you could almost view it as a new indication of this group of patients that we currently don't have access to. So that's why it's so important. So that's why I say sometimes this could nearly double our addressable market.

So maybe you could now like review the data that you did share from the Phase I in terms of bioavailability data and speak to how that then could translate as we look to Phase III results later this year?

Yes. So the data that we presented was bioavailability information and data from our Phase I study. The simple portion is that the -- takes a lot of data to get an answer. But the answer is that it's about 60% bioavailable. So when you give it into the subcutaneous compartment, about 60% of that material will make it into the vein. So when you -- all you have to do, I make it sound very simple and took a lot of work on the team. But in essence, all you really have to do is come up with -- put enough material in. So when you lose 40% of it, 60% makes it into the blood, and that is an equivalent amount to what you're giving IV. So it doesn't have to be complicated.

And if you do that, and we're giving -- just put it the numbers, I mean, we're giving our quarterly regimen is 400 milligrams on day 1, 400 milligrams on day 15, 400 milligrams on day 3 months, whatever, right? So that's 1,200 milligrams given in the first 6 months. We're looking at the AUC 0 to 24 weeks of the first 6 months. That is the same -- that is to match off against our IV dose of 150 milligrams on day 1, 450 or 600 total milligrams, 1,200 times 0.6, 720, divided by 600 comes up at 1.2. We have very fancy models that came out with 1.21. I mean it's almost hard not to -- I mean if you put it in, it's hard not to get an AUC that matches if you know the bioavailability.

So that's where we are. The study is designed -- the Phase III study is designed to look primarily at non-inferiority, which means that you have to have instead of what I calculate as a 1.2, you have to be above 0.8, right? So for us to see bioavailability drop so low as to see 1.2 turn into 0.8, you'd really be based on the confidence intervals around the information we have today, you'd really be in a tail, if you think of a normal distribution curve, you're way out on a tail. If that were to happen, which we think is highly unlikely, we still have the every other month, which would shift from 1.58 would go fad on down and would land directly in the profile. So between the 2, we've got a lot of safety margin. We think we have a ton of safety margin, obviously, on the quarterly.

Just to confirm, once you get past the loading dose math kind of changes the way that math works.

No, you get 400 milligrams every 3 months. And again, in the second half of the year, just to give you a sense, we've got 400 milligrams, 400 milligrams matching off against 450 milligrams. We have 800 to 450 times 0.6, you're going to land in a very nice location across the board.

And in terms of like form factor and tolerability, what can you share about the amount of volume that you're administering with this subcutaneous and what you saw from a tolerability perspective data?

Yes. So we're using a 2 mL injection fits nicely into an auto-injector. The first study that we reported is from clinician injecting the 2 mLs, where we said that we'll be doing a bridging study, which should start relatively soon to bridge from the injection, the 2 mL injection by a clinician to an auto-injector injection. So 2 mLs is a good number there. And then in terms of the tolerability, we saw, I think we saw 2 injection-related reactions, which were I think mild-to-moderate, remember what we said in the report, but it's pretty minor. I mean we did, I think, about 225 injections, over 80% of them were at the 2 mL volume. So not a lot of injection site reactions. And then the systemic injection reactions, so more like IRRs was also like 20%, which is actually really consistent with what we saw in ENHANCE for both arms essentially at about 20% infusion reactions.

Can you frame us for the competitive landscape? You mentioned already that about 35% of patients are getting subcu today. How do you think every 12-week kind of dose would fit relative to the competitive set?

We think it will be really well received. The current competitor is at 1 injection per month, the 12 injections per year. This would take the injections down to 4 per year. We think in our research, 4 versus 12, there's a pretty stark market share benefit to us. The competitor is working on an every other month of product. We still think less is always going to be better. And we haven't even started the process of comparing ublituximab itself versus ofatumumab, right? So we spent a lot of time because we compete against ocrelizumab, we spent a lot of time differentiating the molecules. We spent almost no time because we don't compete today against ofatumumab, right?

So once we start to showcase some of those differences, and it's quite interesting, too, because while OCREVUS is a little bit -- I'm going to call it dirty, it's not really dirty, but it has a dual -- really has a pretty balanced mechanism between ADC and CDC. Ofatumumab has been engineered specifically to have high levels of CDC and almost very low levels of ADCC, whereas we were engineered the exact opposite to have really high levels of ADCC and very little level of CDC. And I think once we start to engage with clinicians on the differentiation between the molecules, I think that plus the convenience factor puts us in a great position to do what we believe we can do and what we want to do is to be the #1 in the subcu marketplace. We want to be #1 overall CD20. We're on our way on the IV side, and we're looking forward to hopefully being very disruptive in the subcu side.

Helpful. And so then as you think about where the subcutaneous market could go relative to the CD20 class, I guess, how do you think introducing a 12-week could change sort of the share from a broader class perspective?

It is hard to know. We do think there are dynamics that over time may push more of the market out of the infusion suite and into the home. There have been and continue to be site of care issues with academic centers. You'd be -- I think you'd be shocked to know that in some or many academic centers, the charge for the infusion service itself exceeds the price of the drug, process that for a second, think if you will. So in those cases, you will see that the insurance companies will push outside of those centers. Now a lot of times, they'll end up at an AIC an independent infusion center. But a lot of times, that will just -- the clinician may at that point, use a subcu product. So the more and more that the insurance companies push those site of care issues, the more you'll see drop off into subcu use or fall off into subcu use.

How should we think about pricing for the subcutaneous product relative to the IV kind of with that in mind, there's a different kind of cost dynamic, et cetera?

Yes. So I guess the first thing to notice is that with the bioavailability being different, just on a milligram per milligram basis, we're using, I can say, almost double because I can't do the math on 60%, but it's 40%, whatever that inverse relationship is. But we're using a significantly more material. So on a milligram per milligram basis. And that market is different. Ofatumumab is priced at a very different price point than the IV, and there's different rebate programs. So we're going to have to review the pricing in the context of the marketplace that we're going into, but also based on the milligrams that we'll be delivering.

One of the things that you did when you came into the IV market was compete with OCREVUS on price. Is that something that you think you would need to do here in the subcutaneous setting, particularly given the differentiation we talked about on the clinical side?

I think we're still evaluating. One thing that the team did do successfully and you're alluding to is we did take price against ocrelizumab. And I'd like to say it was something that was targeted at ocrelizumab, but really it was targeted at the payers, right? And the idea was we wanted to get, call it, great coverage as early as possible, right? One of the hardest things is at the time of launch, if you get clinicians excited and they can't use the compound, you kind of lose them, right? And it takes them a little while to come back and they have a recollection of the challenge that they had.

And so even to this day, there are some clinicians who maybe started early, and we'll talk to them and say, yes, it's harder to get to, like no, no, no. That was the first 3 months. We're 3.5 years in across pretty much have parity with ocrelizumab. There are some places where we do have priority. But overall, we have parity, and that was the team's goal. The team did a lot of research, and they believe that coming in at the lower price would get us early access. They were successful. I think within 6 months of launch, we were at 80% coverage. And within a year, we were over 90%.

And do you have the best patent estate across the CD20 therapies with duration into the 40s. But as these biosimilar products come to market for the other agents in the category, I guess, what do you expect to see in terms of how that changes class share dynamics?

Yes. I've often said tongue-in-cheek that as you know, our goal is to be the #1 anti-CD20 in the marketplace. And if we don't get there before ocrelizumab goes biosimilar, we'll certainly be there after, right? So I think that in a tongue-in-cheek way of me saying, we firmly believe that a tailwind will be ocrelizumab biosimilar to us. Generally speaking, in this marketplace, prescribers prefer not to use generics or biosimilars. We're starting to see this dynamic emerge with TYSABRI today. We see a lot of switches from TYSABRI for clinicians who are being forced to go on to the biosimilar. We anticipate something very similar will occur.

And in terms of pricing, we're already at about a 25% discount to the price of ocrelizumab. Most biosimilars don't even come in that low. So there's not a huge economic incentive for them to go cross category to step through for us. There is a lot of incentive for them to get as many patients off of ocrelizumab and not to biosimilar because they can immediately save [indiscernible] whenever the biosimilar comes in on pricing. But to go cross an economic incentive from price. And also you're talking about a franchise that we'll have in place that they'd be giving up a lot in volume, our volume and our price to go to something else.

Great. Maybe you could speak a little bit on the OpEx side. I guess, in terms of near term, any additional investments you feel the need to make either on the DTC side or in terms of commercial infrastructure? And then how should we think about that as you look forward in bringing a subcutaneous product to market over the next couple of years?

Yes. So just in terms of where we are today, we launched with a, I'd say, a relatively modest commercial team, but mighty. We hired really some of the best people in the business, but relatively small in comparison with the plan that we'd continually grow out that as the demand required, we would continue to rise to the occasion. We've continued to do so. So we've built our team. I think our commercial team is in a great place right now. We continue to look for opportunities to optimize certain, whether it's geographies or even down to places, right? So if we see that we're doing great in one city, but one center isn't performing because we don't have connectivity there. If we could find someone who has connectivity, we'll go ahead and hire that person. We can overlap from a geography standpoint. But for the most part, we've got a field team that's operating at a high level. And like I said, I think if we see the opportunity to improve, we'll continue to add people. So that's the field force.

And so it continues to grow modestly on a year-over-year basis. The big toggle is DTC, right? That's something that you could spend like our competitors, $100 million plus or like us something in probably the $25 million to $50 million range, right? So we could toggle that up at any point that we want to. And we do -- we toggle up and down as we see things and opportunities, and we continue to experiment. I mean we don't think that it has been figured out yet what the optimal across the whole industry. I mean the pharma companies, their simple model is just grow the spet against the wall and see what sticks. And for the most part, they're going to get an ROI above 1, right? So it's not going to be 0. They're going to get ROI, but we're not playing for a 1% ROI. We're -- ROI is dramatically higher.

So we'll continue to look for opportunities to continue to build that out. And so that is the big OpEx toggle. You could spend a lot or you could toggle back down. And as we see opportunities where we see things that are working, we'll lean into them. So that's where we are on the DTC. And then you asked about how does that change as we move into subcu. So from a field force perspective, subcu is really overlapping with what we're doing today, right? We have -- I think we've calculated that probably 80% -- we're covering about 80% of the subcu prescribers with our current field force. So really highly -- from an operational leverage perspective, I mean this is and different -- even different from MG, which is pretty darn good. We've got a lot of overlap there. But it's not like going into a whole another area, you have to rebuild the entire machine. This is very incremental OpEx on top of a full almost equivalent opportunity set.

So that -- but then DTC, again, is a toggle, right? It's how much do we want to do to promote and what makes the most sense. So there'll be -- that will be incremental, but it will be somewhat probably substituting, right? Because the brand is the brand, right? We'll be the only ones who have both products in the marketplace. So even as we're DTCing the subcu, we're selling the IV, right? If patient comes in and is asking about BRIUMVI, they're still asking about BRIUMVI. And the clinician is going to direct them in the preference that they want.

So with that in mind, you're looking at relatively significant operating leverage and cash flow generation over the intermediate term. I guess how do you think then about allocating that capital across shareholder returns, business development, investing in the pipeline?

Yes. It's the easy way [indiscernible] answer is all of the above. So I'm not going to say that, although I just did. Yes, I mean we've been -- I mean, I think of companies our size, we've been very quick to start with the repurchase program, right? We recognize that we are going to be generating significant cash flow over the coming years and buying our shares inexpensively where they sit today versus waiting to buy them in a few years at much higher prices, we thought was a good idea, and we leveraged up to do that. Having said that, we still have -- through that leverage, we have enough bandwidth to look for new opportunities, which we continue to do and, of course, invest in the pipeline. So -- and what we have in front of us.

So we don't feel at all restricted by cash. We feel like we have access to unlimited cash to do whatever part we want. So if we see a business development opportunity that is a great deal, and we think we can generate a high level of IRR, we will do that. If not, we know that we have a high level of IRR embedded in our repurchases. We'll continue to do that. But yes, I think we're poised to use that cash flow judiciously, cautiously. And again, we've been talking about doing BD deals for a very long time. We've executed one in Azer-cel, which I haven't talked about. So we talk a lot, we review everything. There's not one deal that's been signed that's close to MS over the last few years that we didn't -- we weren't probably the -- we were the preferred partner, and we chose not to do it.

Well with that, I think we're out of time. Thanks again for joining us.

Thank you. Appreciate it.

Greetings, and welcome to the TG Therapeutics First Quarter Conference Call and Webcast. [Operator Instructions] 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 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. 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 in 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. BRIUMVI net product revenue in quarter 1, ahead of our guidance of $185 million to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone. And as we move toward $1 billion annualized run rate expected before year-end, we continue to believe we are still early in the BRIUMVI 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 BRIUMVI, not just on efficacy, but on the overall treatment experience, thus translating into durable, repeatable growth. And importantly, the data continues to support that differentiation.

Earlier this year, we were pleased to see our 5-year follow-up data from the ULTIMATE I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BRIUMVI along with a consistent safety and tolerability profile over time. At AAN earlier this month, we continue 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 BRIUMVI, which showed improvement in patient-reported wearing off symptoms, sometimes referred to as the clot gap after switching to BRIUMVI. 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 III ENHANCE study, evaluating initiation of BRIUMVI therapy with a single 600-milligram IV infusion as compared to the currently approved schedule of 600 milligrams divided into two infusions, on day 1 and on day 15. I'm pleased to report that based on current time lines, we expect top line data from this Phase III 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 are developing a self-administered at-home version of BRIUMVI, 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 I dose escalation bioavailability study, evaluating subcu 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 2 subcu dosing schedules, every 2 months and quarterly dosing with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks. We are 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 subcu BRIUMVI, assuming a positive outcome and regulatory approval. And I know many of you have been waiting for the Phase I bioavailability data.

We now expect to share those results in the coming weeks. Strategically, it's important to understand what subcu 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 of BRIUMVI in additional autoimmune indications.

We view BRIUMVI as a pipeline within a product with a long runway supported by patent protection into the 2040s. Myasthenia Gravis, we've completed our Phase I work and expect to initiate a Phase II 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 have validated the implications could be significant. And finally, azer-cel, 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 the business, repurchasing shares or pursuing external opportunities or investments. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, for more detailed commercial update. Adam, please go ahead.

Thanks, Mike, and good morning, everyone. I'll pick up on a few themes that Mike just laid out, particularly around consistency, durability and execution because that's exactly what we're seeing on the commercial side of the business. We delivered approximately $195 million in U.S. net revenue in Q1, exceeding our guidance range and growing 63% year-over-year, our 12th consecutive quarter of sequential growth since launch. We saw record new patient enrollments in the quarter, and March was our highest month ever. As a result of the strong first quarter, we're raising full year U.S. revenue guidance to $885 million to $900 million, and we're providing Q2 guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. And importantly, we've now reached a meaningful milestone. More than 25,000 patients have been prescribed BRIUMVI globally. That's important because at this point, we're no longer talking about early adoption. We're talking about a growing installed base of patients being treated in the real world.

At its core, this is a recurring treatment model. Patients who start BRIUMVI are typically treated every 6 months, and we continue to see strong persistence over time, stronger than what we originally modeled. That means our revenue base doesn't reset each year, it builds. Each cohort of new patients adds to an expanding base of recurring demand. As that base grows, we're developing greater visibility into underlying demand and growth becomes more predictable over time. The outperformance we saw in Q1 and the raise in guidance reflects both that growing base, including better-than-expected persistence and stronger-than-expected new patient demand. Importantly, we guide conservatively on that new patient growth layer, and we raise when the data supports it. That combination is what's driving the business today. And as we said before, the more patients that go on BRIUMVI, the more patients will go on BRIUMVI, and we're seeing that dynamic take hold. Let me be direct about the competitive environment.

We compete against established products backed by large organizations, and we don't underestimate that. At the same time, in Q1, we continued to grow sequentially while outpacing both competitors and the broader MS market. We've been growing IV share consistently, and we're now the #1 CD20 by dynamic share in private practices with infusion capabilities. Why is that happening? Because we're delivering on the factors that matter most to physicians, a compelling clinical profile, operational simplicity and a consistent treatment experience. The 1-hour infusion, twice yearly dosing and long-term data all contribute to that. And when physicians put a patient on BRIUMVI and that patient has a positive outcome, that physician becomes a repeat prescriber. Since November, we've seen consistent increases in total monthly prescribers with March setting a new high. And most importantly, we're increasing uptake with treatment-naive patients, patients starting their CD20 journey on BRIUMVI, not switching to it.

The share of naive patients in our mix continues to rise, which we view as the strongest leading indicator of long-term market position. The momentum we're seeing comes down to execution and doing a few things consistently well. We've reduced friction across the treatment journey, improving time to start and conversion rates. We've expanded our reach and deepened our presence across accounts. And our DTC efforts are helping to increase patient awareness with more patients entering the office already informed about BRIUMVI. This is exactly what we set out to build, a commercial engine that can deliver consistent execution, support long-term growth and scale over time. And importantly, we're doing this while still early in the life cycle. As Mike outlined, we have two programs that help explain why we believe the long-term opportunity is meaningfully larger than what is reflected today. First, ENHANCE.

This is about simplifying the initiation process by eliminating the day 15 infusion. If successful, we would expect it to enhance operational efficiency and make it easier for physicians and infusion centers to get patients started on BRIUMVI. We view this as an incremental improvement to an already strong IV offering, one that can further support adoption. Second, our subcutaneous patient administered formulation. This is a much more significant strategic opportunity. Today, the subcutaneous patient-administered segment represents roughly 35% of the anti-CD20 market, a segment we are not participating in today. So this is not about taking share within our existing IV business. This is about opening up a new segment of the market. If successful, subcu BRIUMVI would allow us to reach patients who prefer or require at-home self-administration, compete directly in a large and growing segment of the market and meaningfully expand the overall addressable opportunity. And when you look at this holistically, IV plus subcu is not just incremental expansion.

It has the potential to redefine the scale of the BRIUMVI franchise over time. Importantly, the current business is already performing at a high level. We don't need these programs to deliver on our near-term expectations. But over time, they have the potential to meaningfully expand both the reach and long-term value of BRIUMVI. So to summarize, we've outperformed expectations in Q1, driven by strong underlying demand. We're seeing continued expansion in both patients and prescribers. Our execution is translating into durable, increasingly predictable growth, and we're significantly raising our 2026 outlook. We now have over 25,000 patients globally, and that base continues to grow.

We're approaching a $1 billion annualized run rate, supported by a model that is becoming more scalable over time. And with IV and subcu, we're building a franchise that has the potential to compete across the full spectrum of the anti-CD20 market. When you consider the size of the IV market, the portion we'll be able to access with subcutaneous and the trajectory we're seeing today, we believe the long-term opportunity for BRIUMVI is well above where consensus peak estimate sales sit today and ultimately more consistent with the leading assets in the category. Let me now turn the call over to Sean Power, our CFO, for a detailed financial update.

Thanks, Adam. A few things to highlight on the financial side. As Mike and Adam highlighted, we came in ahead of expectations. U.S. net product revenue in Q1 was approximately $195 million, up 63% versus the same quarter last year. Total net product revenue was $201 million when including product sales to Neuroxpharm, our ex-U.S. partner. Add in $3.6 million of license, royalty and other revenue and total revenue for the quarter was $205 million.

On the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based comp, was approximately $117 million for the quarter. That year-over-year increase reflects continued investment across the business. On the R&D side, a milestone expense under our Precision Biosciences agreement and higher clinical costs, partially offset by lower subcutaneous manufacturing and development spend. And on the SG&A side, expanded marketing and media investment supporting BRIUMVI's continued growth. Even with that investment, revenue growth continues to outpace expense growth, and that dynamic drove operating income of $34.8 million compared to $8.6 million in Q1 of last year. One item worth flagging below the operating line was a onetime $9.2 million charge related to the refinancing of our Blue Owl facility, of which approximately 50% was noncash. All that nets to net income for the quarter of $19.8 million or $0.12 per diluted share compared to $5.1 million or $0.03 per diluted share a year ago.

On the balance sheet, we ended the quarter with approximately $573 million in cash, cash equivalents and investment securities, up from roughly $200 million at year-end, reflecting primarily the proceeds from the expanded Blue Owl facility. From a capital allocation standpoint, we repurchased over 3 million shares during the quarter at an average price of roughly $30. Since launching the program, we bought back approximately 6.8 million shares at an average price of approximately $29, nearly 5% of shares outstanding, leaving us with 153 million shares outstanding today. Turning to guidance. We're raising our full year total global revenue guidance to approximately $925 million.

On expenses, we continue to expect full year operating costs of approximately $350 million, excluding stock-based comp, plus approximately $100 million for subcutaneous manufacturing and secondary manufacturer start-up activities. As we've noted previously, those manufacturing costs are expensed through R&D as incurred. So if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods. All in all, it was a strong quarter. Revenue ahead of expectations, operating income up meaningfully year-over-year and a balance sheet that gives us real flexibility going forward. With that, I'll turn the call back over to the conference operator to begin the Q&A.

[Operator Instructions] First question comes from Corinne Johnson with Goldman Sachs.

Maybe could you just speak to the market opportunity for the subcutaneous product? If you're able to bring a 12-week versus 8-week formulation to the market, do you see that as going to meaningfully different in terms of your ability to gain share in that currently untapped population?

Sure. Adam, do you want to tackle that one?

Sure. Yes. Thanks for the question, Corinne. As we mentioned, that segment represents about 35% of the CD20 market today. One, we do not compete in. And our perspective is this is expanding into a new patient population rather than shifting patients within our existing base. We think of these as largely distinct segments with different patients and physician preferences. And importantly, I think, as Mike mentioned, puts us in position to compete across both the IV and subcu space across the entire CD20 landscape.

We think that Q3 -- to your question about dosing, we think Q3 obviously would be better than incrementally better. I think both are going to be great. But I think we subscribe to less is more. But I think both would be a very strong profile, and we feel good about the opportunity for both whichever way it works out.

Next question, Brian Cheng with JPMorgan.

Just first, can you talk a little bit about the cadence of data from the ENHANCE trial and the Phase I bioavailability data? In your prepared remarks, you said both data will be coming in the coming weeks. So which one should we expect first? Are both data coming at the same time? And I have a follow-up.

Yes. In terms of timing, we don't have the exact timing. We just know that things are coming in soon. So we just basically thought we'd let people know that, that data was coming.

Okay. Earlier during you talked about the dynamics of persistence, and you talked about how persistence is stronger than you have anticipated. Can you provide a little bit more color to that? And how much does the DTC campaign so far in driving patients coming to physician practice and asking for BRIUMVI?

Thanks for the question, Brian. Adam, do you want to tackle this one?

Sure. I mean on the persistent side, obviously, we're encouraged, given my remarks, we're encouraged by what we're seeing on the persistence, particularly as patients move into the second year of treatment where trends have been better than expected. And we think these patterns that we're seeing are supportive of the durability of the patient experience, which obviously reflects the tolerability and efficacy of BRIUMVI. That said, still early, and we will continue to monitor it, but we're growing in confidence as we continue to build as the data matures. And it comes down to sustainability of efficacy and tolerability. And then generally, when patients do well, they stay on therapy and that drives persistence.

As far as DTC, we're encouraged. We've been putting effort into DTC over the last year or so. We've been encouraged with the markers and indicators of success. We'll continue to invest in the space. We think this is a patient driven. They do have shared decision-making in this market. And so we're going to continue to focus on it, and we are encouraged by what we're seeing so far.

Next question, Tara Bancroft with TD Cowen.

This is Greg on for Tara. So you reiterated top line Phase III data for the subcu BRIUMVI around year-end 2026 or early next year. Can you provide any additional color on the cadence from data readout to filing? And how quickly the subcu formulation become commercially available, assuming a favorable outcome?

Sure. So our target is to have the subcu available sometime in 2028. In terms of the cadence of filing after the completion of that study, our goal is to get that filed as soon as we can. We've got a few other studies we'll need to do in the interim to get the filing package complete, including the bridge to the auto-injector. But yes, I mean, for '28, as soon as early as possible, '27, we're going to get that filing done. That's the goal for '28 approval. Again, it's -- the one thing we can't control is the -- about a 12-month review process. So that's the timing of that. Was there a last part of that question, I'm sorry. No, that covers my question.

Next question, Roger Song with Jefferies.

This is Cha Cha Yang on for Roger. So I was wondering if you could speak to what you think the impact of remibrutinib's potential approval in MS would be on BRIUMVI, but also on the CD20 class as a whole?

Yes. Thanks for the question. So we continue to await product profiles for all the BTKs as they've come through the clinical trials. Each one in turn has had some difficulties, I would say, in producing data that is convincing of a clinical benefit over risk. We'll see how fenebrutinib does at the agency and remibrutinib is yet to come. So I think we just have to wait. I mean, overall, we've maintained our position that there's certainly a home for these drugs in certain patient populations, particularly patients who are potentially secondary -- nonactive secondary progressive where we're not labeled. So I think there's room for -- remember, there's still a big oral market. I think there's room for a BTK with the right profile to participate in that oral marketplace. But we don't think it's a drug class that will have a material impact on the CD20 class.

Next question, Michael DiFiore with Evercore ISI.

Just one for me. Just given Roche's potential twice yearly home OCREVUS device and KESIMPTA's longer interval work, what dosing profile does subcu guy need to have in order to be meaningfully differentiated? Is every 2-month dosing enough? Or is quarterly dosing really the commercial bar given where we're headed?

Sure. Thanks for the question, Michael. Look, as Adam mentioned, it's a competitive market. Everyone is trying to do their best to improve their product profile to meet the needs and challenges that these individuals with MS face, and we're certainly doing our part. Obviously, we've said before, we feel that -- and Adam said it earlier, the market is large. It can probably get larger on the subcu side.

We'll continue to obviously have a very big presence in the IV sector, whereas I don't think the other -- I don't think OCREVUS' long-term plan is to participate much longer in the IV marketplace. And as you mentioned, they're working on their own at-home on-body device. So like I said, from the standpoint of the patient, this is all great. And as Adam mentioned earlier, every two months or every three months will be a really strong offering. Again, it's BRIUMVI still loaded into the auto-injector, which means that all the differentiation that we have on the IV side, on the molecule itself will continue to exist as we go into the marketing effort on the subcu side. So convenience is one thing. Obviously, as Adam said, quarterly is going to be incrementally better than every other month.

We feel obviously very confident in our ability to deliver a quarterly product, but I think we'll let the data speak for itself as it solely comes out. But yes, I think we're going to do great. I mean we've done quite well in the IV space. Again, BRIUMVI is a molecule and the convenience factors all come together. So I think it's a package of competitive products and ours is going to be, I think, highly competitive in this marketplace. And like I said, we think we're going to do really, really well in this space.

Next question, Emily Bodnar with H.C. Wainwright.

Maybe one on the updated guidance. Obviously, quite an uptick from the fourth quarter guidance. So maybe just talk a bit more on your confidence for why you think the growth you saw in Q1 might be sustained for the rest of the year? And also on operating expenses, it looks like that was up quite a bit in the first quarter. So maybe just touch on expectations for the rest of the year.

Sure. Adam, do you want to start on the updated guidance?

Yes, sure. Thanks for the question, Emily. Q1 performance, as I mentioned, was driven by strength across all key drivers, including record number of new patient starts and better-than-expected persistence. I think we're seeing that momentum continue into Q2. And as I outlined in my prepared remarks, the model really has two components to it. It's a growing recurring base with continued new patient demand. And so the strength of Q1 reflects both of these working together and gives us confidence in the updated full year guidance.

Sean, do you want to talk about the OpEx?

Sure. Thanks, Emily. Yes, on the OpEx front, as we said in our prepared remarks, we expect full year OpEx, again, which we define as R&D and SG&A, excluding stock-based comp, to be roughly $350 million, plus an additional $100 million for subcutaneous manufacturing work and secondary manufacturer preparation. So yes, Q1 was up a little bit higher than perhaps that range would guide, but we are still reiterating that guidance for the full year.

Next question, Prakhar Agrawal with Cantor Fitzgerald.

This is Jennifer on behalf of Cantor. Congrats on the quarter. I have two quick questions. One on the capital allocation and share buyback versus meaningful BD. Since you have quite a lot of cash. What's the plan on that? And then quickly on the gross to net discount for Q1, how do you expect that for the rest of the year?

Sure. Adam, why don't you or Sean handle the gross to net, and I'll talk about the use of cash.

Sure. Yes. As I mentioned in the Q4 call, we did have gross to net dynamics in Q1, but these were largely in line with our expectations. As I've mentioned before, gross to net can vary from quarter-to-quarter. But for the year, we expect it to average out around 65%.

And then in terms of use of cash and capital allocation and share buybacks versus BD. Look, we continue to be highly selective in our BD efforts. We've seen some interesting things. We like some stuff. We're disciplined about what we're willing to pay for programs and assets. And of course, we're always happy to buy our shares if others are not willing to value them at fair value. So we'll continue to buy back shares. I think that's -- until we see some significant price reassessment, we'll continue to be buying shares back with our cash. And like I said, yes, we're out there looking at new opportunities quite aggressively. And like I said, we've been disciplined about executing and certainly disciplined about price.

Next question, William Wood with B. Riley Securities.

Just thinking about in terms of sort of apart from BRIUMVI, you've got the earlier stage Azer-cel running in your open-label in PPMS. I'm just curious with that trial readout coming up later this year, if there's anything that you could sort of provide at a top level on what you might be seeing, what gives you confidence with advancing that? And then any -- yes, I'll stop there.

Appreciate it. Yes, for Azer-cel, it's still early. We are excited to be moving up in the dose escalation, but it's a challenging study logistically to get to a point where we can open up enrollment. So we'll continue to push forward. I think we're just about on the pen ultimate dose. I think we'll be able to start that in the next 1 to 2 weeks. So we're getting close. We're getting warm, but there's a significant delay between each individual patient while we strive to get to the dose that we're targeting. Safety, of course, is going to be the most important piece. Secondarily, of course, there's going to be some biomarkers of activity, whether we're deleting B cells, oligoclonal bands in the CNS. So we are hopeful to be able to present some of that data. But again, it's still early, but we're enthusiastic about it. We think the -- again, the rationale for these drugs has not subsided, and we do think that there's a real opportunity, but it's still early.

I would like to turn the floor over to Michael Weiss for closing remarks.

Great. Thank you, operator, and thanks again, everyone, for joining us this morning. Let me just briefly recap.

We outperformed expectations commercially with strong revenue and record patient starts. We advanced two key life cycle programs, both with the near-term catalysts. We're expanding development efforts beyond MS into new indications, and we are allocating capital with discipline and intent. We've said this before, and it's worth repeating, we do not see BRIUMVI simply as a successful product. We see it as a multibillion-dollar franchise with a long runway, supported by patent protection into the 2040s. And importantly, even as we approach $1 billion run rate, we believe we're still early in realizing that full potential. We remain focused on executing the business and maximizing long-term value.

I want to thank our shareholders for their continued support, our TG team for their commitment to our mission and the patients we serve and of course, to the patients and health care providers for their trust in us. We take that responsibility very seriously. Thank you all again for joining us, and have a great day.

This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.

Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2025 Earnings Call. [Operator Instructions] Please note, this conference is being recorded.

I would now like to turn the conference over to your host, Jenna Bosco, Chief Communications Officer. Please proceed.

Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' Fourth Quarter and Year-end 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 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 products.

Please note that these statements are subject to risks and uncertainties that could 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 corporate website at www.tgtherapeutics.com.

With that, I'll turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone, and thank you for joining us today. 2025 was a defining year for TG Therapeutics. We didn't just grow, we scaled, we strengthened and we demonstrated that BRIUMVI is becoming a foundational therapy in relapsing multiple sclerosis.

Let's start with what matters most, performance. We delivered approximately $616 million in total global revenue, the vast majority of which came from $594 million of BRIUMVI U.S. net sales, and we capped the year with a strong fourth quarter of $183 million. That represents approximately 92% year-over-year growth and 20% sequential growth from Q4 over Q3.

Those numbers reflect something simple. Physicians are choosing BRIUMVI, patients are staying on BRIUMVI and confidence in the product continues to build. That confidence is reinforced by our 6-year open-label extension data from ULTIMATE I and II presented at ECTRIMS this past September.

Nearly 90% of the patients were free from 24-week confirmed disability progression after 6 years of continuous treatment, 6 years and the relapse rate seen in the 6-year BRIUMVI treatment translates into 1 relapse occurring in every 83 years of treatment. And importantly, no new safety signals emerged.

On the R&D front, we advanced our Phase III ENHANCE study, evaluating consolidation of the day 1 and day 15 BRIUMVI infusions into a single 600-milligram dose. Enrollment is complete. We expect top line data midyear with the potential 2027 launch of this consolidated treatment schedule. If successful, this could meaningfully simplify the treatment experience. We believe effective therapies should not only work well, but be as convenient as possible for patients, which brings me to our subcutaneous program.

We are developing a self-administered at-home subcu BRIUMVI to be delivered via an auto-injector. Our Phase III study is evaluating 2 dosing schedules, every 2 months and quarterly administration. The trial is now approximately 75% enrolled, and we're targeting pivotal top-line data later this year or early next year with a potential 2028 launch.

We see this program as having significant commercial potential. The subcu portion of the anti-CD20 market is substantial and being able to compete in this space, we believe, could nearly double our total addressable market opportunity. Beyond MS, we are actively advancing plans to explore BRIUMVI in additional autoimmune indications, including having treated a series of Myasthenia Gravis patients in a Phase I study.

And finally, Azer-cel, our allogeneic anti-CD19 CAR-T is being studied in patients with progressive MS. It's still early, but momentum is building. Our clinical trial sites are identifying patients quickly. In fact, demand is exceeding available trial slots. That tells us something important. There is a real unmet medical need. We look forward to sharing updates from this program later this year.

Turning to some financials. I'll leave the details to Adam and Sean, but suffice to say, we expect to continue generating positive cash flow in 2026 and beyond, which gives us a rare financial flexibility within the biotech universe. We've been clear about our capital priorities, invest to maximize the multibillion-dollar BRIUMVI opportunity, expand the pipeline judiciously for sustained future growth, repurchase shares when we believe TG is materially undervalued and otherwise allocate capital in ways that generate long-term returns.

With respect to share buybacks, we completed our first $100 million share repurchase program, and the Board authorized an additional $100 million last year. At current levels, we view our shares as significantly undervalued relative to the cash flow profile we expect over the coming years, and we will not hesitate to act accordingly, including adding leverage to reduce our share count.

And to be clear, we purchased shares to create long-term value, not for the optics. Before closing, I want to touch on something I'm personally very proud of. Many of you saw Christina Applegate launched Next In MS during Super Bowl 60. We are honored to partner with her on this platform.

Next In MS is about honest, unfiltered conversations about life with MS, about difficult realities about resilience beyond treatment decisions. We're not just commercializing BRIUMVI. We're building the MS company that shows up for patients beyond the prescription. To close, at TG, our mission remains simple: deliver meaningful therapies, simplify treatment, create lasting value for patients and shareholders.

I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, for a detailed commercial update. Adam, go ahead.

Thanks, Mike, and good morning, everyone. 2025 was a year of continued acceleration for BRIUMVI, and we closed the year with another strong quarter of execution and growth, further expanding our position in the RMS market. For the fourth quarter of 2025, we delivered U.S. net sales of $183 million and continued sequential expansion versus Q3.

For the full year, BRIUMVI U.S. net revenue reached $594 million, reflecting sustained momentum built on the strong commercial foundation established in the first 3 years of launch. Growth throughout the year was driven by consistent and increasing year-over-year new patient starts, continued expansion of our prescriber base, better-than-expected persistence, greater depth within high-volume infusion accounts.

Importantly, growth was broad-based across both academic and community settings, reflecting rising physician confidence and expanding utilization. BRIUMVI continues to strengthen its competitive position within a large and growing anti-CD20 market.

Within the IV anti-CD20 segment, we continue to gain dynamic share. Physicians remain focused on proven efficacy, long-term safety experience and operational efficiency and BRIUMVI's 1-hour twice yearly maintenance infusion profile supported by multiyear data continues to resonate in a competitive environment.

We are seeing a balanced mix of treatment-naive and switch patients, reinforcing both the breadth of the opportunity and the continued expansion of our footprint within the class. Our execution remains strong across all commercial functions, and TG is emerging as a leader in the therapeutic category. As the franchise continues to scale, we have continued to invest behind the business.

During 2025, we expanded our field organization to deepen coverage in high-opportunity geographies and broaden our reach among community neurologists and independent infusion centers. That expanded footprint is driving increased prescriber engagement and positions us to accelerate further penetration in 2026. We also expanded our direct-to-patient engagement efforts during the year.

In addition to our national BRIUMVI campaign, as Mike mentioned, we recently announced our partnership with Christina Applegate to launch NextInMS.com, a new educational platform designed to provide resources and information to individuals living with RMS and their caregivers.

Christina's long-standing advocacy within the MS community brings credibility and visibility to broader conversations around navigating life with MS. Through Next In MS, our focus is on education, empowerment and encouraging informed dialogue between patients and their health care providers.

As BRIUMVI continues to scale, we believe it's important to engage thoughtfully and meaningfully within the MS community, and this partnership reflects our growing leadership position in the space and our long-term commitment to supporting the MS community. As we look to 2026, we are reaffirming our previously issued full year U.S. BRIUMVI net revenue guidance of $825 million to $850 million, with total global revenue at $875 million to $900 million.

Our outlook reflects continued growth driven by expanding prescriber adoption, increasing depth within existing accounts and ongoing share gains and a growing installed base of patients with strong persistence on therapy. We've entered 2026 with real momentum. New patient starts are tracking to our strongest level since launch.

Physician confidence continues to build and our share trajectory within the IV anti-CD20 segment remains favorable. Importantly, after operating alongside competitive entrants for several quarters, BRIUMVI has demonstrated that it can compete effectively and continue to expand its position within the class.

Turning to the first quarter and based on the strong demand trends we are seeing earlier in the year, we expect U.S. revenue to grow sequentially over Q4 levels to approximately $185 million to $190 million, even after accounting for typical seasonal headwinds. As we have mentioned previously, the first quarter generally reflects routine factors such as benefit reverifications and gross to net variability driven by deductible resets, which can influence the timing of net revenue early in the year.

These dynamics are consistent with what we have seen historically in the category and are fully incorporated into our full year guidance. We also expect ex-U.S. revenue to be in the range of $5 million to $10 million for the first quarter. Taken together, the strength of demand and continued share expansion gives us confidence in our reaffirmed guidance and our ability to drive meaningful growth in 2026.

To summarize, we have delivered another year of strong growth in 2025. We continue to gain share in a competitive IV anti-CD20 market. We have invested meaningfully in field expansion and direct-to-consumer initiatives to support the next phase of growth. We are off to a very strong start in 2026, tracking to record new patient enrollments entering the year. BRIUMVI is now a scaled and expanding franchise, and we believe the commercial platform we've built positions us well to continue driving meaningful growth in the year ahead.

With that, I'll turn it over to Sean to walk through the financials.

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we released our fourth quarter and full year 2025 financial results, which are available in the Investors and Media section of our website. I'll begin with a discussion of our revenue for the fourth quarter and full year, which Adam briefly touched on. We are pleased to report U.S. BRIUMVI net product revenue of $182.7 million during the fourth quarter.

Total net product revenue for the quarter was $189.1 million, which includes $6.4 million of product revenue related to sales to our partner, Neuraxpharm in support of ex-U.S. commercialization. For the full year 2025, global revenue was approximately $616 million, predominantly comprised of $594 million in U.S. BRIUMVI net product revenue, $12.8 million in revenue from products supplied to Neuraxpharm and $9.4 million in royalty and other revenue.

Our gross margin for the quarter was slightly below typical as a result of timing of sales to our ex-U.S. partner and a onetime inventory reserve. Shifting to operating expenses, which we define as R&D and SG&A, excluding noncash comp. Full year 2025 expenses totaled approximately $328 million, in line with our prior guidance of $300 million to $320 million.

The modest variance was driven primarily by incremental manufacturing and development costs related to subcutaneous BRIUMVI and continued commercial investment. Revenue growth significantly exceeded the increase in operating expenses, resulting in operating income of $123 million for the year. For the fourth quarter, net income was $23 million or $0.14 per diluted share.

For the full year 2025, net income totaled $447.2 million or $2.77 per diluted share compared to $23.4 million or $0.15 per diluted share in 2024. As a reminder, 2025 results including nonrecurring income tax benefit of approximately $340 million, which relates primarily to the release of our deferred tax asset valuation allowance in the third quarter.

Turning to our balance sheet and capital position. We ended the year with more than $600 million in current assets, approximately $200 million in cash, cash equivalents and investment securities, $300 million in accounts receivable and $140 million in inventory. During the year, we completed our previously authorized $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share.

The Board has since authorized an additional $100 million share repurchase program, reflecting continued confidence in our long-term outlook. Looking ahead to 2026, we expect full year operating expenses of approximately $350 million, excluding noncash comp, plus approximately $100 million in expenses associated with subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up activities. These costs run through R&D today, but if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods as the manufacturing expense has already been recognized, positively impacting gross margin in future periods.

In summary, 2025 represented a year of strong execution for TG. We delivered substantial revenue growth, generated meaningful operating income and positioned the company for continued expansion in 2026.

With that, I will now turn the call back over to the conference operator to begin the Q&A.

[Operator Instructions] The first question comes from Michael DiFiore with Evercore ISI.

2 for me. Roche has recently highlighted accelerating subcu uptake in community practices and Novartis continues to emphasize strong growth in the -- in self-administered first-line use. You've described broad momentum across academic and community settings in the HCP administered segment.

So my question is, can you help us think about how those dynamics fit together and where you're currently seeing the strongest incremental momentum by site of care? And I have a follow-up.

Sure. Thanks for the question. Adam, do you want to go ahead?

Yes, sure. Thanks for the question, Mike. So listen, we've now operated alongside the new entry from Roche for several quarters now. We continue to seek share gains in the IV segment. Physicians seem to be -- continue to be driven by clinical data, long-term data, operational considerations. It seems like the majority of the de novo business seems to be coming from Ocrevus IV. But importantly, we're also -- we're not seeing any decreases in the switches from Ocrevus to BRIUMVI. So that's an important factor, too.

And in terms of what's driving our share, we're seeing growth across both private practice and academic centers. We think it's the durability of the clinical profile, as Mike mentioned, the 6-year data, especially the safety data within there and the efficacy data. We continue to believe the operational advantages of BRIUMVI, the 1-hour infusion, the twice a year are relevant for patients and infusion centers. We continue to expand prescriber breadth and depth with our expansion of our field force. And I think we're seeing great momentum.

And as I mentioned, the underlying demand is very strong. Enrollments are tracking to the highest since launch. And we continue to see share gains across the board, across patient types, across sites of care. And importantly, also, we see very strong persistence. So overall, really strong and the fundamentals are great.

Very helpful. And my follow-up question is on gross to net. You previously noted that gross to net can fluctuate with site of care mix, particularly in hospital exposure. So as these -- as growth evolves across channels, are you seeing any meaningful change in gross to net assumptions? Or does your prior framework still hold?

Yes. As I mentioned in the prepared remarks, gross to net can vary quarter-to-quarter. In Q1, gross to net is influenced by deductible resets and high utilization of co-pay programs. Consistent with what we've seen historically, does not represent a structural change in how we think about gross to net. It's a Q1 dynamic.

Our full year guide reflects the net revenue profile for this year. It is a Q1 dynamic that seems to be consistent with what we see across the CD20 space, also other specialty products, and it's fully baked into our full year guidance. So I hope that answers the question.

The next question comes from Tara Bancroft with TD Cowen.

So I'm curious to hear your thoughts around positioning now that you're several years into this launch, but guidance for Q1 and the year are pretty conservative. So I was hoping you could give us some more detail on the proportion of new versus switch patients and how much revenue now is from patients that are remaining on treatment for these extended periods of time and whether new patient starts are still growing or leveling off and why?

Thanks. Adam, it's all you still.

Go ahead. Yes. Thanks for the question, Tara. Listen, I think I'll just reiterate what we're seeing. The majority -- we're seeing record new patient enrollments here. We're still seeing growth. We're seeing great share gains in the IV segment.

And I think that's being driven by the things that I mentioned, durability of the clinical profile, the 6-year data, the operational advantages, our investment in both the expansion of our field force. It could very well be our DTC efforts, although hard to single out a single factor here. But all these things, I think, are leading to continued confidence in the product across the board, and that's why we're seeing such a great demand that we're seeing right now.

As far as new versus switch, I mentioned a couple of quarters ago, the business becomes more predictable as we've now walked into more switch. Sorry, not switch, repeat patients. So we are seeing more and more repeat patients as a bigger part of our business as that patients continue to pancake from quarter-to-quarter and stay on therapy for long periods of time.

As I mentioned before, also, our persistence is quite strong. And so we're seeing patients staying on therapy for -- it looks like out to week 48, week 72, week 96 seems very good. So all those things are leading to growth. We do expect -- we do expect growth in 2026 and meaningful growth in our guidance.

The next question comes from Prakhar Agrawal with Cantor Fitzgerald.

Congrats on the quarter. Maybe just a follow-up on the new patient start. Adam, you said you're seeing good growth in new patient starts, but I'm trying to connect the dots between your commentary as well as what's implied in the guidance because based on our math, the guidance would imply a more modest year-on-year growth on new patient starts. So how much conservatism is baked into the guidance? Or should we expect a lot higher gross to net for full year 2026?

And secondly, how much incremental investments would you need for the subcu launch? And what would be the plans to commercialize subcu BRIUMVI ex-U.S. given that it seems to be a large market for drugs like Kesimpta, so there could be a lot of value there.

Yes. Mike, do you want me to continue to go here?

Yes. Why don't you and just start off. Go ahead.

Yes. I mean, look, we're early in the year here. Like I said, we're seeing a strong start to the year. We're early here. We'll continue to update the guidance as we see fit, as we continue to get more time with -- we'll see how we do throughout the year. It's, of course, possible that we could see outperformance that could come from continued new patient starts. We could see incremental share gains. We could see better-than-expected persistence.

That's -- we're being somewhat conservative here. But so far, the year is starting are strong, but we're -- again, we're only in February. So we'll see how that goes. And then in Q1, we're seeing just a disconnect in Q1 prior to your question, strong new patient growth. However, you do face the Q1 issues and headwinds as I described on gross to net and benefit reverification.

And then Mike, I don't know if you want to take the subcu question.

Sure. Yes. I mean in terms of incremental investment, Prakhar, I mean, Adam can answer this as well as me, but overlap between our current field force for IV to subcu is, I think, about 80%. So I don't -- there's not a huge incremental cost. There will obviously be some incremental marketing costs associated with it.

But overall, it's not a huge incremental investment to launch subcu in the U.S. As for ex-U.S., we expect our partners at Neurax will opt into that program when offered it. And so we'll work with them on the ex-U.S. strategy at that point.

The next question comes from Corinne Johnson, Goldman Sachs.

Maybe continuing on the conversation on subcu. Some of the competitors started providing color on the role I think a subcu offering could play over time with respect to IV versus subcu share. I guess what is your perspective there, particularly given the variety of dosing options within subcu that could be coming over the next couple of years, including obviously, BRIUMVI?

Sure. I'll give it a start, Adam, you can supplement if you like. Look, the subcu portion of the market has been relatively stable for a while, I think 35% to maybe 40% it fluctuates up and down quarter-to-quarter. Long term, the more options that are available creates more energy in that space and more people marketing in that space.

So I do believe that over time, with new options available, that space can expand and probably will expand. To what extent is hard to predict at this moment, but I do think there's probably some forces that will push people towards subcu at home over time. And yes, so I do think that market will continue to -- Adam, any additional thoughts?

No, that's perfect. Sean.

The next question comes from Brian Cheng with JPMorgan.

Just looking at the existing sales force, is there any potential need for a refocus of their goal this year? And are there pockets of opportunities that you think might be more important this year just given more adoption on the subcu side? And then on a related note, how should we think about the expenses projection related to the DTC campaign that you have set up for this year? What magnitude of a step-up can we expect?

Thanks, Brian. Adam, do you want to lead us off here?

Sure. Yes. Thanks for the question, Brian. We -- as I've mentioned before, we continue to take a strategic expansion approach to our field force. We have continued to add people as we've seen opportunities to do so. We're looking at it strategically. We add people where we see opportunity and continue to hire the best people that we can find in the area. As far as a new goal, I don't know that it needs a new goal. I think we have a pay-for-performance culture and an accountable culture. We've hired the best people in the industry.

This team is fantastic, and they continue to deliver on what we've asked them to do. So I don't think we need a new goal. I think we have a great team. I'm very confident in the commercial functions, as I mentioned, I think they're doing an excellent job.

The next question comes from William Wood with B. Riley.

So thinking about some of your -- the subcu Phase III that's going on currently. I'm just curious when we might actually see or if there's a chance that we might see any subcu bioequivalence data generated. So how we can sort of think about that, the Phase III readout later this year?

And then also in terms of some of the earlier-stage programs, I know you've got Phase I ongoing in Myasthenia Gravis. But just curious if and when we might expect to see some of these earlier stage data from the earlier-stage programs, any of that reading out later this year at conference?

Sure. Thanks for the question, William. In terms of subcu, yes, as we discussed, Phase III is approximately 75% enrolled. We continue to be excited about that program and it's -- the opportunity for us there. Phase III data is expected later this year or early next year. In terms of the Phase I bioequivalence data, it's been coming in. The study is actually, I think, just about to close formally. So there's overlap between the Phase III and the Phase I just for follow-up and all those kinds of things. So the Phase I is, I think, just about closing up or maybe it's not there yet, but getting close.

We'll take a look at the timing of conferences and the timing of the Phase III data and see if it makes sense to actually put the Phase I data out or not based on timing of where we are at the Phase III and the conference schedule that's available once that data is fully evaluated and presentable format.

So the answer is, I don't know as of yet. But like I said, based on the preliminary data, we're feeling very good about the program and very excited about the Phase III outcome that will be later this year. In terms of Phase I MG, I have not talked to the team yet about what their plans are for presenting that information.

Anecdotally, I know the study -- the patients who have been treated with MG look quite good in terms of their response to the drug, which I don't think is much of a surprise to anybody. But I'll check back with the team and I'll be able to give some more guidance later on that once I find out what their plans are.

The next question comes from Emily Bodnar with H.C. Wainwright.

In terms of the ENHANCE trial and launching that next year, can you just talk about how you think about that from a market perspective and if you see any potential for kind of incremental revenue growth with implementing that launch? And then maybe if you could just talk a bit about some early metrics that you're tracking with the DTC launch and the Next In MS program?

Sure. Thanks for the question, Emily. So in terms of the ENHANCE trial launch and incremental potential from that, I'll take a crack, Adam, and then please jump in. We've done some market research. Generally speaking, it's extremely positive feedback on eliminating the second dose, the convenience factor for both patient and for centers is viewed very high in the research we're doing. Anecdotally, I've personally been in advisory boards recently where people are even more enthusiastic than they've previously been about reducing that first dose.

In terms of incremental market share gains, I think from our research and from the anecdotal experience that we have, we do believe that it will help us continue to gain market share gains in this area. Again, it's just -- every time we make it easier, it's just -- it's better. In terms of -- the other side of it is in terms of switches, people are excited about it to use this on label for switches, which we think will be helpful there.

And generally speaking, if you're looking at going on IV OCREVUS or IV BRIUMVI, you now have another reason or another convenience reason to go on to BRIUMVI, eliminating that first dose, which they still have -- we'll still have 2 doses upfront for their IV plus the much longer infusion. So yes, we do think that will have a positive impact, and we're looking forward to that launch.

Adam, anything more on that topic?

No, I think you covered it. That was great.

Okay. And then the second part of the question was early metrics on DTC. I know that's one of Adam's favorite topics, so I'll hand it off to him.

Yes. No, thanks for the question, Emily, and asking about our partnership with Christina and Next In MS. As I mentioned, we view these efforts as building long-term category leadership. The feedback from customers and patients and advocacy groups has been incredibly positive. so far. Obviously, we're looking at in terms of metrics that you asked about, the engagement with the content has been -- has exceeded our expectations.

We're looking at the number of people who sign up on our website, the number of website visits, number of sessions, and we'll continue to track it. But so far, everything has exceeded our expectations and the engagement with the materials has been fantastic.

Thank you. At this time, I would like to turn the call back to Mike Weiss for closing comments.

Great. Thank you, operator. And thanks again, everyone, for joining us. '25 was a very strong year for us. '26, we expect to be even stronger, including a number of very exciting catalysts, including the top line data from our ENHANCE trial, some preliminary data from Azer-cel and then perhaps the biggest one of all at the end of the year or early next year, pivotal data from the subcutaneous BRIUMVI program.

To our TG employees, thank you always for your dedication to those living with MS. To the health care providers, individuals with MS and their families. Thank you for your trust. And to our long-term shareholders, thank you for recognizing the potential of what we are building here at TG. We're just getting started. Have a great day.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

Good afternoon, everyone. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the senior biotech analysts here at the firm. On stage, we have Mike Weiss, who is the CEO of TG Therapeutics.

I'll now pass the mic to their CEO for a short presentation, followed by a live audience Q&A. Mike, the stage is yours.

Great. Thank you, Brian, and thanks, everyone, for joining us. I'm going to get started here. Just before I do, let me just mention that I will make some forward-looking statements. For those of you who are interested, I do encourage you to review our public disclosure documents available on the line.

Just a way of quick background for those of you who may not be that familiar with TG Therapeutics. We were founded in 2012 with a focus on B-cell-mediated diseases. These can range from autoimmune diseases to neuroinflammatory as well as cancer. But today, we're focused primarily on MS. We have one approved drug, BRIUMVI for multiple sclerosis, which is approaching blockbuster status. We have 2 pivotal trials ongoing to expand the utilization and total addressable market for BRIUMVI, and we have 3 programs under development.

So there it is BRIUMVI. This is our approved anti-CD20 monoclonal antibody. It was approved in late December of '22 and launched in January of '23, so a little under 3 years ago. And -- but not only is available in the U.S., but it's available now globally. Our partners at Neuraxpharm are commercializing it across Europe and the rest of the world. It's now available in 16 countries.

And to date, over 20,000 patients have been prescribed BRIUMVI, most of those in the United States. So I'm going to drill down a little bit on the anti-CD20 market, which is the one that BRIUMVI competes in. It's -- that market itself captures about 50% of the dynamic market share, so that's the new prescriptions and also has about 50% of the overall market share. And what I'm going to share with you is that we expect BRIUMVI to grow with the sector because remember, we only have -- CD20's only have 50% market share today. So there's still room to grow. And then I'm going to show how we're going to grow within the CD20 sector.

So today, there's about $10 billion in sales for this class of drugs. And just to frame it out, there's 3 anti-CD20s approved for MS, again, one of which is including BRIUMVI. I'm going to refer to this slide twice today. So you'll see it now, you get to see it again later, so you don't have to memorize it momentarily, but we're going to talk about it in a few. So this is the market within -- this is the DMT market basically that is only the CD20 portion. And what you can see is that about 65% of the patients choose to go on an IV CD20 and about 35% choose a patient-administered product. So that's a subcu product that you can do at home.

We are competing in the HCP or health care provider administered space with BRIUMVI. And then on the other side, that 35% market share is covered by one single agent, but hopefully not for long. So we're going to talk a little bit about our efforts to compete in that space as well. So despite this competitive market, our goal is to be the #1 prescribed anti-CD20 in relapsing forms of MS based on dynamic market share. And I'm going to talk a little bit about how we got to the point we're at today and how we're going to get to this number.

So we've seen significant uptake in our portion of that market, that HCP administered anti-CD20 portion of the market in less than 3 years, and I'm going to go through some stats with you. Greater than 97% of the top 200 MS centers are using BRIUMVI. Approximately 90% of all high decile -- decile health care providers are prescribing BRIUMVI.

That translates to about 1/3 market share in our portion of that market, the HCP administered portion. So essentially, 1 in every 3 patients who chooses an IV product is choosing BRIUMVI. And overall, that brings us to about a 20% total market share, give or take.

In terms of revenue, what does that translate into in revenue? So cumulatively, well, as of the end of the year, we had $992 million in cumulative revenues in less than 3 years. As of today, fresh update, I'm sure, this is unofficial number, but I'm sure we've crossed over $1 billion in cumulative net sales as of 2 weeks into the year. And then let's talk about 2026.

We had a really nice year, $616 million in total global revenues. And then for the portion that is the U.S., which is most of it, $594 million this year in BRIUMVI U.S. net revenue. That represents about a year-over-year. And we ended with a really solid fourth quarter. We had $182 million in the fourth quarter. We were targeting about $175 million for the quarter. So a nice outperformance and had a really nice growth, 20% growth quarter-over-quarter Q3 to Q4.

And even for the year at $594 million, I think when we started the year, which is why it is challenging for us, for any company, I think, to give guidance 2 weeks into the year for the full year, we were predicting and targeting about $525 million in revenues at the start of the year. We ended up closer to $600 million. So a really fantastic year. The team performed great. BRIUMVI was very well accepted, but it does show some of the challenges in forecasting.

So how have we gotten to this point? Really nice revenues, really nice market share continuing to grow. We have a tagline that is first and only anti-CD20 for MS that's delivered in a 1-hour infusion every 6 months after the starting dose. It's a nice catch phrase, a little long. We could probably come up with something shorter and better. But to start, that's pretty good. But it's not -- it doesn't tell the whole story, right? The whole story is we believe we have a best-in-class product. We've hired the best-in-class people, and we delivered it at the best-in-class price.

And I think if you look at any business, if you could deliver those 3 things, you're going to do pretty good. And that's, I think, why we're getting there. I'm going to drill down a little bit here on the -- some of the profile here. The product has shown consistent efficacy and safety over a 6-year period. In our pivotal Phase III trial, we had the only CD20 that came in with an ARR under 0.01. And after 6 years of treatment, the annualized relapse rate is 0.012, which translates roughly into 1 relapse in every 83 years of treatment.

So not too shabby, I would say, pretty good data there. The label also is without breast cancer risk and colitis. This is a patient population that skews to women, maybe over 70%, 75% and it skews to younger women, sort of 40 -- 20s to 40s. So that's something that people will take into consideration. This agent has also been glycoengineered for enhanced ADCC. In other diseases where they've actually compared antibodies that have not been ADCC versus ones who have been engineered for this. In those diseases, the ones with enhanced ADCC have performed better in clinical trials. We do think that, that accounts for the efficacy and activity of our product. And then the people. We hired a team of folks who knew the MS space. They come from major companies have been doing this for years. We put literally an all-star team together from every company that's been involved in MS and you can see years and years of experience.

And then we wrapped it in this customer service model. It's almost this obsession with making life easier for folks to get on to our drug. And I think that's probably one of the more important things that is not fully realized. If you're difficult to deal with companies -- getting patients on drug is not as simple as just writing a script, especially when it's an IV product, being there and being helpful to getting those patients on whatever you can do to be helpful, it makes a difference.

And then on the price side. Some may say, if you come in with the best-in-class product, you might want to charge a higher price. We did somewhat the opposite. We came in at the lowest price of any branded MS treatment, not only of any CD20 treatment, but any branded CD20 -- I mean any branded treatment at all. And we think that definitely has the potential for some savings in the health care system as people transition over to BRIUMVI.

And the other thing we're really proud of is that in a closed bidding process, we outbid 2 major foreign pharmaceutical companies to win the VA contract, Veterans Administration contract. And in doing so, we're offering to our veterans anti-CD20 at the lowest price for BRIUMVI available in the U.S., and I believe it's probably the lowest price available in any major country. So we were very proud to be able to do that.

So -- that's a little bit how we got to where we are. Now I'm going to do a little forward-looking. Where are we going? What are we going to do? '26 is a relatively straightforward year. We're going to build on what we've done with our health care provider engagement. We're going to amplify patient awareness, and we're going to continue to drive market share.

On the HCP side, we've probably doubled our field force since we launched. That was by design. We started, as you can see, a few slides earlier, I said the 90% of the top decile doctors are using BRIUMVI. That was not by accident. That was deliberate. We hired a team focused on those clinicians, and we've expanded basically beyond that, beyond that. And now in year 4 of our launch, we're really looking at a more strategic surgical precise addition to our team to increase reach and frequency with high opportunity health care providers. Those are actually defined by a proprietary targeting algorithm that our team has created.

So it's really a nice approach, really targeted. I think in terms of -- like I said, we probably doubled our sales force to date. We're probably this year, a little more modest, maybe a 10% to 20% increase in the field force to address the targeting that we want to do this year.

Now the next piece of it is the patient side. In MS, maybe more so than some other diseases, there's a lot of patient involvement in the decision-making, they call it shared decision-making. So getting out to the patients is important. We started out in the first 2 years, we didn't do a ton of this because we were really focused on the clinicians. And the idea was we didn't want patients going to clinicians that didn't know about the drug. So that was very deliberate, I think, very effective in our efforts. But as we grow and we want to build further, patient awareness is going to be key.

In 2025, we did a lot of really nice things. We learned a lot. We're taking it forward. We're really leaning into the patient awareness campaigns in '26 across television, digital channels, again, to really build that patient awareness and to continue to help us drive our market share. Beyond '26, we've got a nice group of potential launches coming, which we also think will continue to drive growth. First one is scheduled or targeted for 2027.

This is an improvement or enhancement to our IV protocol. We're going to talk about it momentarily, but this is a consolidation of 2 doses to simplify the onboarding to BRIUMVI. We've gotten a lot of good feedback from clinicians about this idea, and I'll describe this in momentarily with the clinical trial.

In 2028, the hope would be to launch our BRIUMVI subcu. This is -- this could be a very material product for us. And like I said, I'm going to spend more time later, so I'm not going to say too much now about that one. And then as we move into 2029 and beyond, we think there's an opportunity to launch BRIUMVI in additional indications outside of MS as well as novel drugs. We have azer-cel in our pipeline, which I'll talk about. And we also have an active BD development program, which we think could lead to launches in this time frame. So it kind of really lines up nicely with what we're doing.

So let's talk about the first one that I was referring to. So the consolidated dosing to simplify the onboarding basically to IV BRIUMVI. So we have our ENHANCE pivotal trial. And essentially, we're comparing the approved IV dosing, which you can see on the left-hand side. And what we do, like every other CD20 that's given an infusion, you do a day 1 dose, you do a day 15 dose and then you start again 6 months later and you give -- in our case, you just give 1 infusion every 24 weeks.

The proposed IV dosing now would be basically to combine or consolidate day 1 and day 15 into a single dose. And like I said, when you talk to the clinicians, the centers, it's surprising how much let's call it inconvenience. It's not like the end of the world, but it is inconvenient for them to have to schedule 2 doses within 2 weeks, and it's also inconvenient for the patients. So we'll be the only IV product in MS that's approved if we get successful, just start, you're on and you don't have to come back for 6 months.

This study is fully enrolled. Top line data is expected in the middle of this year. And the target launch, as I discussed previously, is for 2027. All right. Now let's focus on something that's, I think, super exciting. The development of a self-administered subcu BRIUMVI. So we have a pivotal study that's up and running. And again, very similar. If you look at the left side of the panel, it's essentially the approved IV dosing versus the proposed subcu dosing, and our goal is to match basically PK over a 24-week period.

Getting approvals, 24-week period. And you can see the schedule here, very similar to the approved IV dosing, except it's with an injection. You get a dose on day 1, you get a dose on day 15 and every either 8 or 12 weeks. So we have 2 arms. 1 is looking at every other month dosing. 1 is looking at every third month of dosing. The target profile, again, here is to be a self-administered subcu with an auto-injector. So something very comparable in terms of format to the one compound that I referred to that's approved as a self-injectable. So we're very excited about this study update.

The Phase III trial is greater than 50% enrolled. Top line data, we're expecting toward the end of this year into early next year. And again, as I mentioned, with a target launch potentially in 2028. I told you I was going to come back to this picture. Hopefully, you guys didn't forget that. So why are we so excited about subcu BRIUMVI?

Again, this is an opportunity to significantly increase the total addressable market. Now we are competing right now in the larger portion of the market that's at 65% seen there, but we have no way of competing today in that 35% of the market. So one of the key threshold questions asked the patient, once the clinician and the patient decide that the CD20 is the right treatment for them, the threshold question is, do you want to inject yourself? Or do you want to come in and get injected by or infused by a clinician, right?

Right now, about 35%, sometimes depending on the month and the quarter, it could be up to 40%. But on average, about 35% of the patients are choosing that. If they choose that option, we don't compete, right? We don't have an offering for them today. So that's why this is so important for us and exciting for us. So this is something that just completely augments our IV business. This does not cannibalize any business because, again, if you're choosing the at-home option, you're going to get it.

So this is really nice. It gets us into a unique and distinct patient segment. It positions TG as the only company. And for the foreseeable future, I don't see anyone else that's going to get there with an offering in each of these markets. So one where you can go to your doctor and get it or the other, you can do it at home. So we're really meeting the doctors and the patients, where they are and where they want to be in their treatment.

And then the final piece, which is from a financial side, I think somewhat incredible. I mean there's -- I know there's lots of opportunities to launch drugs in new indications and new diseases, and we will probably do that eventually, and we're working on some other areas outside of MS. But the leverage of doing something within MS is really incredible. So this is something where we will use essentially the current commercial infrastructure with minimal incremental cost. And just to give you a sense of what that means in one particular part of this, about 85% of the target health care providers that are prescribing the self-administered product are already covered by our field force.

So really very little additive cost of entering this market, all potential upside. So I'm going to go now to that third bullet in that escalating slide earlier, expanding BRIUMVI in MS beyond MS. So -- we have definitely ideas for how we're going to grow the BRIUMVI brand. I think one thing that people don't fully appreciate with BRIUMVI, and that's probably our fault because we've been very hesitant to move forward in different indications while we were building out the MS platform.

But I think as we develop subcu BRIUMVI, I think it reignites the concept of BRIUMVI as a pipeline and a product. And many of you are aware that we've already started a Phase I trial with patients with MG, and that is ongoing. And we're in the process of evaluating a number of other potential indications for BRIUMVI.

And then, of course, as I mentioned earlier, we have azer-cel. This is our allogeneic off-the-shelf CD19 CAR-T product. We're in patients with progressive MS, again, starting in our home base, which is MS. We're hoping to have some data from this study in this year, 2026. And we're moving into additional indications, NMO, MG, CIDP also should be open this year.

So just to finish this -- just to finish this thread, let's talk about some of the R&D goals while we're on the subject. So as I've described, we're looking to present midyear top line data from the ENHANCE trial. This is the consolidation of the doses. This is certainly not in the order of importance, but certainly in the order of chronology. Middle of the year or second half of the year rather, we're looking to present data from our azer-cel progressive MS cohort.

And then as I mentioned, later in the year or early next year, top line data from our subcu program. So very data-rich 2 pivotal readouts this year or maybe leaking into early next year and potentially some data on a very novel product and program.

In terms of new trials, we'd like to be in a position, and we'd like to start a registration-directed trial this year for BRIUMVI in an indication outside of MS as well as commence an additional series of potentially exploratory studies for BRIUMVI and as you heard, azer-cel in a number of new indications as well.

Anyone interested in some financial guidance for the year, waited to the very end, hope we peaked your curiosity. So we're very excited about 2026. As we've said before, we see BRIUMVI well on track to becoming a multibillion-dollar franchise in the United States. In terms of guidance for global net revenue for 2026, we're starting off the year targeting approximately $875 million to $900 million for this year.

And most of that, again, is going to be from our U.S. net revenues of BRIUMVI, approximately $825 million to $850 million in BRIUMVI U.S. net revenue. And then on the expense side, giving some guidance here.

This year, we broke out from core operating expenses, which is really the classical R&D and SG&A, which we're targeting around $350 million for this year versus I put onetime expenses in quotes. It's a onetime series of expenses associated with the build-out of our inventory for subcu BRIUMVI and bringing on our secondary manufacturer.

So those expenses are probably going to carry for 1 or 2 years. But once they get those -- whether the site is approved for the secondary manufacturer or subcu BRIUMVI is approved, all further production goes into inventory. And these dollars that came out of here will go to reduce our cost of goods.

So they're not pure expenses. So I separate out, but all the numbers are there, so you could see them, and we'll probably keep this going for a year or 2, so you can see the core expenses, which I think is a critical component here. And if you look at assuming growth in revenues and core expenses definitely going to be increasing, but not at a crazy level. You could see just by looking at these numbers, we're going to have a significant amount of cash flow and EBITDA over the next several years.

One thing we have talked about, we have opened, I think right now, we have $100 million of capacity under our repurchase plan, our stock repurchase plan. I think at these levels of stock price, we're more likely than not to increase the level of share repurchases, but that is yet to be determined. But just to give you a sense of where our heads are at.

And then just to finish the session with some highlights, sort of summarize where we are. BRIUMVI continues to outperform expectations. Again, we started this year at about $525 million. I think the analysts were also there. We ended up closer to $600 million. Year-over-year growth has been strong. The commercial momentum continues to build. So very excited about how BRIUMVI is performing. And just to set the stage, the IV portion of this market alone represents a multibillion-dollar opportunity for BRIUMVI before we layer in the subcu, which has its own market and its own opportunity for us. And we also think that is a multibillion-dollar opportunity.

Again, I think it's been underestimated the pipeline and a product potential for BRIUMVI. And I think subcu BRIUMVI will open the door and get people understanding the potential opportunity for us there. And then there's growth potentially with other molecules like azer-cel.

Patents we didn't talk about that in today's session, but we have patents into the mid-2040s. We're expecting a -- we have an issued composition matter on the glycosylation of the molecule through 2042 or '43, and we're expecting a subcu formulation path through 2045. So really a long-term opportunity, again, to exploit multiple indications, really get BRIUMVI out there into new spaces.

And then finally, sort of alluded to it, but we have significant operating leverage. Our OpEx maintains at probably one of the lowest levels of any company with our revenue base, and we see profitability accelerating. So with that, I will pause. I know I'm sure there's going to be some crazy questions. We should get to that.

Crazy. So let's start with the Q&A. For those who are in the audience, feel free to raise your hands. And for those who are joining us virtually, you can also submit questions on the portal.

Mike, just to kick off here, as we think about 2026, do you see the dynamics being the same just on a quarter-to-quarter basis? And you have also laid out revenue guidance here. So it will be helpful if you can also layer in some thoughts about what went into this revenue guidance for the year ahead?

Yes. So we have a forecasting team, like I said, they've been providing us these numbers. They use -- they have a prediction of how many patients are going to be newly enrolled in a given year. They have a prediction about how many patients are going to come back. They have prediction about gross to net for the year, and that all comes together.

And then there's a few other -- those are probably the core, I would say, 3 inputs. I think there's 4 or 5 other major inputs that they work with but they plug it in, they come up with a matrix and they come out with the recommendation for us.

And any thoughts about just how we should think about quarter-to-quarter 2026, how does that compare to 2025? Is there any difference that you would expect? Or should we expect kind of a similar dynamics in terms of going from 1Q to 2Q? How should we think about 2026 versus 2025?

Yes. In the absence of any new information, I'm going to have to say, yes, I would assume the same cadence as 2025.

Okay. And in your prepared remarks, you talk about you expect 10% to 20% sales force growth. Correct me, if I'm wrong. And just curious how we should think about how -- where are you placing those additional sales force. And have you identified any additional pocket of opportunities in the physicians who are taking care of these MS patients today?

Yes. So you are correct. So it's about a 10% to 20%, give or take. I mean, this is not no precision that, but approximately another 10% to 20%. In the field force, we have a number of different field teams. So that is an aggregate number. But as I mentioned, we have a proprietary algorithm that identifies high potential targets for us. folks who ought to be using BRIUMVI and may not be using it as much as they should or not using it at all. And so we will build the field force around making sure that we can get to those folks with the right level of frequency.

Any questions from the audience?

I think you said the net revenues in the U.S. -- the figure for the net revenues in the U.S. was $594 million for last year, 20,000 patients in the U.S., so around 30,000. I don't know, if that's blended for your VA discount. But my question is about you made a point to say that when you were pricing in the go-to-market phase, you said, let's go into the low end and really establish a presence and work from their other ways to grow.

What I'm curious about is I think you said the company was formed in 2012. So it was a 10-year journey to get it approved in '22? And along the way, you must have had other pricing assumptions. I'm curious how did that evolve over time? And how do they compare to the payer discussions, which is kind of the ultimate reality check on how you're going to get through the market.

Yes. So I can't say that in 2012, we were thinking too much about the pricing considerations. But as we got closer to the market, of course, we had comparables out there. So there's an approved IV product that was priced. So really, at the end of the day, it was through conversations with payers about what would help get us coverage as quickly as possible.

One of the things we felt was super important was making sure that if we spoke to a clinician, that they could write for it and their patient we covered. And I think we had 80%, 85% coverage within the first 6 months. So it really was a successful strategy and continues to be, I believe, a successful strategy. We have parity coverage almost everywhere, not everywhere, but almost everywhere. We have some priority status. They still carry some priority status. So I think net-net, it worked out -- the strategy worked out well. But yes, it was definitely a discussion with payers and understanding where we can make sure that we can clear the market and get coverage as quickly as possible.

That came in at the -- obviously, at the end of the process, and it didn't require drastic retuning of your assumptions. It's more like some tweaking?

Yes. Yes. I mean, again, like I said, before we launched within several years before we launched, there was a price out there for competitors. So I think within a range -- I mean, we did come in at about a 25% discount, but I don't think it impacted modeling of what we thought the opportunity was or was not.

Just within the CD20 class. What are you hearing from the ground on the demand for subcu versus IV. Over time, as studies say, how do you see the split of subcu versus IV?

Yes, it's hard to say. We've -- for a little while, we felt like it was on a continual growth path, but it seems to have settled down. I think there were some quarters, where it was close to 40% but net-net, it seems to have settled down closer to 35% and seems to be relatively stable there. But yes, it is hard to say.

I don't think there's a lose-lose I think there's a win-win situation for us. I mean we're going to -- if we are successful in developing both the subcu and having, of course, the IV, we'll participate in the growth of the overall sector and whether 1 arm grows better than the other arm. I guess we don't care at that point. As long as we're participating and getting our portion of market share -- like I said, we want to grow with the market because we think it's growing, and we want to grow within the CD20 class as we get to our goal of being the #1 prescribed medicine CD20.

In terms of the subcu pricing, how much beyond the subcu be priced relative to where Kesimpta today?

Yes. I mean, look, we will -- as with the IV, we're going to look at the marketplace, we're going to understand what makes sense. I mean we're definitely using on a milligram per milligram basis, we're using a lot more drug to make subcu. So even if you just charge on a milligram basis, it's going to be a higher price point for something like this. But between that and looking at Kesimpta, we'll have a sense of where we ought to be pricing this.

Any questions from the audience? Maybe just switching gears into the competitive dynamic here. How do you think about the BTK class as an emerging class from where you stand today? We could potentially get -- we will get PPMS data and ACTRIMS in a couple of weeks. What will you be looking for in that data set as from where you are -- where you stand today?

Yes. I mean, look, on the primary progressive side, we're completely supportive of any new treatment that could help those patients. It's an area that is underserved. I don't -- I think the rub on being equivalent to ocrelizumab is that most clinicians don't really believe that it's doing all that much.

It's approved which is great. I'm glad there's something that's approved for those patients. So when that PPMS data is actually shown in its fullest, I mean, we'll get some sensitivity around how equivalent it is or if it's -- it was -- I think it was stated it was at least numerically better, but certainly not statistically better. So I think it's going to be 1 of those situations where hard to say. But again, if you have no options, I think it's great for patients to at least try something hopefully, it won't be too toxic.

Obviously, there's liver tox associated with those agents. There's generally not that 1 in particular. Just generally, BTKs have liver tox. They have cardiovascular issues. So there's pros and cons, and they do have their immune modulators. They have plenty of infections as well. It's not like you're going to get rid of CD20 infections by delivering a BTK, you're going to still see infection. So like to see the data. It's hard to say what kind of impact it will have. But hopefully, for those folks who will provide some value.

Thank you for the time. I would love to know -- when you look at rest of the world, obviously, U.S. still makes up the majority of your revenue, but how is that large curve kind of looking? And when you talk about the 10% to 20% increase in sales force, are you really working on establishing more clinician relationships there? Or just speaking about that rest of the world opportunity.

Yes. Thanks for that question. So the rest of the world, we have a partner, Neuraxpharm. So they do the heavy lifting there. So no, our 10% to 20% is purely a U.S. number where we do our commercialization. And I think the team at Neuraxpharm is doing a very nice job. I think their trajectory is going quite well. But we are a passive participant in the ex-U.S. launch and we get milestones, royalties. Yes, that's basically the royalties and milestones.

Can you talk a little bit about just what's ahead in terms of azer-cels in progressive MS. What is a win scenario for azer-cel? And how do you think about what you need before you move into the next step.

Yes. So we picked probably the most challenging area to start with a CAR-T but that's okay. We're going to move into other. So I think safety, first and foremost, can we deliver the agent safely? Does it grow, expand and then hopefully disappear. And when it's in there, does it deplete B cells, there's some other biomarkers that we can look at. But safety is first and foremost for that agent and also for the study.

Like I said, there's not a whole lot you're going to be able to hang your hat on. I mean I could tell you that the patients are feeling great, right? And they're telling us they feel better than they did before, and that's not going to be very useful information, to be honest, and people will say those things. But -- and there's not a lot you can do with someone who has progressive MS, you have to look at them longitudinally to get any real information. And you can't look at a small number of them to get that information because it's too variable. So yes, unfortunately, I think safety and getting to the right dose will be the goal for that study.

Any indications that we can provide and give comfort. Well, of course, we will present those. But as we move into some of the other diseases, MG is one that has a really nice scale that you can use, that's relatively objective, but there is nothing like that for PPMS that would be meaningful.

Great. Just to kind of wrap up our chat here. How do you frame 2026 for TG. If we have the same conversation at the end of this year, where do you think our conversation focus will be?

Look, left this slide up here for that particular reason. I didn't know you're going to ask that question, but yes, I mean, look, it's a big year for TG. We're going to be driving significant revenue. So BRIUMVI IV is going to continue to be the center stage. While we can deliver hopefully 2 pivotal data sets maybe get a -- or hopefully get a registration-directed study open in another indication outside of MS.

And again, we'll see what -- maybe there's some exciting things that come in out from out of azer-cel. Again, you just never know when you're doing clinical trials, what you're going to see. So I think there's revenue growth and 2 pivotal data sets are probably defining 2026 for us.

Well, thank you so much for your time. Thank you.

Thank you.

Greetings, and welcome to the TG Therapeutics' Third Quarter Earnings Call and Webcast. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference 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 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 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 would 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. Please note that these statements are subject to risks and uncertainties that could 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 turn the call over to Mike Weiss, our CEO. Mike?

Thank you, Jenna, and good morning, everyone. I'm pleased to report that TG delivered another strong quarter. Our flagship product, BRIUMVI for relapsing MS continues to outperform, exemplifying what happens when innovation meets execution. We've always believed BRIUMVI had a best-in-class profile, and we've built what we believe is the best-in-class team around it. That combination, great product, great people tends to work out pretty well in most businesses, and it seems to be working out pretty well for us, too.

We're equally committed to continuing to innovate to improve outcomes for those living with MS. That's what's driving the 2 pivotal studies we launched last quarter. The first, ENHANCE, explores in a randomized cohort whether we can consolidate the BRIUMVI day 1 and day 15 doses into a single day 1 infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. The response from sites and patients has been tremendous, so much so that we've already completed enrollment. If all goes as planned, we should have data by the middle of next year and potentially a launch of this new simplified dosing schedule in 2027.

The second is our Phase III subcutaneous ublituximab study, what I'd like to call a true subcu product, short push, auto-injector compatible and designed for self-administration. We're testing two dosing schedules, once every other month and once quarterly. Enrollment is going quite well, and we believe we're on track to finish enrollment in the first half of next year, deliver top line pivotal data in late '26 or early '27 and if positive, setting the stage for potential approval and launch in '28.

We view subcutaneous ublituximab as a major opportunity that can nearly double the total addressable market for BRIUMVI. And if approved, it would make TG the only company offering both IV and self-administered CD20 options, we believe providing us with a unique competitive advantage. Subcu ublituximab may also open up new opportunities for us. For example, we continue to explore the potential of BRIUMVI in MG and have treated a small number of patients with encouraging results.

Beyond BRIUMVI, we're developing azer-cel, our allogeneic CAR T therapy for individuals with progressive MS. It's still early, but for people living with progressive MS, this type of therapy could be life-changing. Looking across our pipeline, I can envision the possibility of meaningful new launches in '27, '28 and '29, each with the potential to drive continued growth into the next decade.

While we innovate, we also remain financially disciplined. We've seen a lot of deals in the market lately. Some look tempting, but we've chosen to stay patient and true to our principles. And when we can't deploy capital better inside the business, we return it to shareholders. During the quarter, we completed our initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50. The Board has now authorized another $100 million program, giving us flexibility to keep doing what makes sense.

Operationally, we continue to be profitable and growing and expect that trend to continue, barring any onetime business development moves that might change the picture temporarily, but strengthen it in the long term.

In closing, Q3 was another quarter of strong execution and meaningful progress. We're delivering on our commercial goals, advancing our development programs and maintaining financial discipline, all while keeping patients at the center of everything we do.

Now I'll hand the call over to Adam Waldman, our Chief Commercial Officer, to provide a detailed BRIUMVI launch update. Adam, go ahead.

Thank you, Mike, and good morning, everyone. I'm excited to share our third quarter commercial performance. As Mike mentioned, TG continues to execute exceptionally well across both our clinical and commercial fronts. And that progress is clearly reflected in another strong quarter for BRIUMVI. U.S. net sales for BRIUMVI in Q3 totaled approximately $153 million, extending our track record of strong sequential and year-over-year growth. BRIUMVI’s performance once again exceeded both our internal targets and the Street's expectation, underscoring the depth and consistency of demand we continue to see across the marketplace.

We continue to see favorable dynamics across key commercial indicators. Demand remains strong, supported by sustained physician engagement and increasing patient awareness. Persistence and repeat prescribing both exceeded expectations, reinforcing our confidence in BRIUMVI’s clinical profile and the positive real-world experiences being reported by physicians and patients.

We also continue to add new prescribers and accounts, broadening our base across academic centers and community neurology practices. We believe the anti-CD20 class will continue to expand as more physicians and patients choose the efficacy, safety and convenience of this treatment approach. The CD20 class now represents nearly $10 billion in annual U.S. MS sales and yet approximately half of all patients remain on other types of disease-modifying therapies, underscoring the significant opportunity that still exists for CD20s and BRIUMVI.

The BRIUMVI value proposition is stronger than ever, a convenient twice yearly 1-hour infusion backed by 6 years of data showing consistent efficacy, durable safety and proven real-world performance. At the 2025 ACTRIMS Conference, data further validated BRIUMVI's long-term benefits and captured significant attention across the MS community.

Results from the open-label extension of the ULTIMATE I and II trials showed that after 6 years of continuous treatment, nearly 90% of patients remain free from disability progression with an annualized relapse rate in the 6th year of treatment of just 0.012, equivalent to 1 relapse every 83 years of patient treatment. The safety profile remains stable with no new safety signals identified, reaffirming BRIUMVI's long-term tolerability and consistency.

Complementing these clinical findings, there was real-world data from the ENABLE observational study, which demonstrated that BRIUMVI's efficacy and infusion tolerability are translating into meaningful measurable outcomes for people living with MS in everyday practice. Together, these data strengthen BRIUMVI's differentiated position as a therapy that we believe combines best-in-class efficacy, a proven safety record and unmatched infusion convenience. This powerful combination continues to resonate with healthcare providers across all settings from large academic centers to community practices and the VA system, where BRIUMVI remains the preferred anti-CD20 therapy.

Another key driver of our ongoing success has been the strategic expansion of our commercial field organization. As outlined in our launch plan, we have methodically grown the team over the last 2 years to align with the market opportunity, ensuring the right reach, capabilities and expertise as adoption of BRIUMVI continues to build, while maintaining the discipline and the precision that defines TG's commercial approach. This strategy has proven highly effective, expanding our reach and helping us drive continued growth.

We will continue to expand selectively as opportunities arise, maintaining a balanced focus on coverage, productivity and operational efficiency. We believe our approach have resulted in one of the most capable and experienced commercial teams in the MS industry, a team that executes with professionalism, consistency and a clear commitment to educating both patients and providers.

Complementing our strategic growth, Q3 also marked the first full quarter of our national television campaign, supported by expanded digital streaming and social media initiatives. These efforts are designed to work together to drive awareness, engagement and patient activation, hopefully sparking meaningful conversations between patients and their healthcare providers about treatment options. Early indicators that these efforts are working are encouraging. Branded search activity, website traffic and quality website visits and overall brand -- a patient brand awareness are all elevated relative to pre-campaign baselines.

And as we move into Q4, we plan to grow and optimize this investment to continue to build awareness and support long-term growth. Looking ahead, we remain confident in our trajectory. Based on the strong year-to-date performance, continued new patient growth and positive persistence trends, we are again raising our full year 2025 U.S. BRIUMVI net revenue guidance from $570 million to $575 million to now approximately $585 million for the full year 2025. This updated guidance reflects favorable demand trends and consistent execution by our commercial team.

Looking beyond 2025, we remain highly confident in BRIUMVI’s long-term potential. With a growing prescriber base, expanding patient engagement, a proven commercial infrastructure and continued investment in our product life cycle, we believe BRIUMVI is on track to become a multibillion-dollar brand in RMS. In summary, Q3 was another strong quarter of execution, consistent performance and continued strategic progress. We're proud of what the team has accomplished this year and look forward to carrying that momentum into year-end and beyond.

I want to thank our team for their ongoing dedication and professionalism. Your commitment continues to drive meaningful results for people living with MS and for TG.

With that, I'll turn it over to Sean to walk through the financials.

Thank you, Adam, and good morning, everyone. Earlier this morning, we released our detailed third quarter 2025 financial results via press release, which is available on the Investors and Media section of our website.

Let's begin with a closer look at our revenue performance. Our third quarter results reflect sustained commercial strength with total revenue reaching $161.7 million, an increase of 93% compared to Q3 '24 and 15% over Q2 '25. Product revenue totaled $159.3 million, driven primarily by $152.9 million in U.S. BRIUMVI net sales.

Turning to expenses. Our total operating expenses, defined as R&D and SG&A, excluding noncash compensation, totaled approximately $86.6 million in the third quarter and approximately $239 million for the 9 months ended September 30. While the quarterly figure is up compared to the second quarter of '25, which came in at approximately $71 million, we remain on track to meet our full year OpEx guidance of approximately $300 million to $320 million. The quarter-over-quarter increase in OpEx was primarily driven by continued investment in R&D for subcutaneous BRIUMVI as well as higher SG&A spend to support the continued expansion of the BRIUMVI commercial footprint.

On the balance sheet side of things, as Mike mentioned, we completed our initial share repurchase program. During the third quarter, we repurchased approximately $78 million of shares at an average price of approximately $28. Following this activity, we ended the third quarter with approximately $178 million in cash, cash equivalents and investment securities. We believe this strong capital position enables us to continue executing on our long-term strategy while preserving flexibility for future investments in our pipeline and operations.

On the bottom line, we are pleased to report GAAP net income of $390.9 million or $2.43 per diluted share for the third quarter of 2025. This compares to $3.9 million or $0.02 per diluted share in the same period last year. Our third quarter results include a nonrecurring income tax benefit of approximately $365 million, driven by the release of our deferred tax asset valuation allowance. For reference, a valuation allowance is recorded against deferred tax assets when it is more likely than not that those assets will not be realized.

Given our track record of profitability, projected operating income and positive outlook, we concluded that a release of the valuation allowance was appropriate as of September 30, 2025. While this release impacts reported GAAP net income and earnings per share, it does not affect our cash position or our day-to-day operating performance. This represents our sixth consecutive quarter of profitability, driven by BRIUMVI revenue growth and disciplined expense management.

In summary, the third quarter was a meaningful step forward for TG. We delivered strong commercial performance, continued to invest in long-term growth opportunities and achieved our sixth consecutive quarter of profitability.

With that, I will now turn the call over to the conference operator to begin the Q&A.

[Operator Instructions] And our first question will come from Tara Bancroft with TD Cowen.

So my question is regarding the guidance. So this updated figure, it implies just a slight slowing of sequential growth in this Q4 versus what we've seen in prior Q4 reports in previous years. So I'm curious to get your thoughts on what kind of headwinds that you're expecting this quarter compared to prior years and maybe also a discussion of which tailwinds from here that can support maybe better-than-expected growth like the DTC efforts, the ENHANCE data, et cetera?

Thanks for the question. Adam, do you want to tackle that one?

Sure. A number of factors in Tara. I think the growth that we assumed in Q4 is actually quite good, 14% quarter-over-quarter in the third year here. I think that's a pretty good growth rate. And the guidance is based on a number of factors. Probably most is patient retention at this point and better-than-expected patient retention that is helping us see demand growth. But as I mentioned, field expansion is also helping us. And hopefully, those media investments will start to see some demand increases as we go forward here, too.

Our next question comes from Brian Cheng with JPMorgan.

Just curious if you're starting to see additional demand coming from the permanent J-code that's in place in April? And then I have a quick follow-up.

Adam?

I think maybe you have the wrong product. We've had a J-code for several years at this point.

And then when you think about the expansion of your field operation, where is the focus of expansion specifically as we turn into fourth quarter and into next year? And how are you measuring the return here?

Adam, you're on a roll, keep going.

Sorry. So the question was expansion of the field force. Is that what you're getting at?

Yes, the expansion of the field force. How are we thinking about the focus here as you think about fourth quarter and into next year? Where is the focus? Where are you expanding specifically?

Sure. Yes. I mean we're seeing growth across all segments, but we're focused on continuing to drive the hospital business. In Q3, we saw hospital demand growth continue to outpace actually the private practice setting. And the addition of our new sales reps has certainly expanded our reach, and we believe that's having a positive impact on the growth that we're seeing. We continue to add new prescribers and new accounts on a very consistent basis. And so we think all that is having an impact. And we think, as I mentioned in the prepared remarks here, I think that's certainly contributing to the growth that we're seeing.

And moving on to Corinne Johnson with Goldman Sachs.

You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for BRIUMVI and MS. Maybe if you could just provide some color on the factors that are underpinning that estimate.

Yes, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. But Corinne, just using some real simple math is how we're getting there. So right now, we think that the subcu portion of the market is about 35% closer to 40% now and growing. So at that level, that would almost double the market opportunity for us again. And if that subcu continues to grow as a percentage of the new starts, so this is -- just to take one step ahead, this is based on dynamic share. So not total share, but dynamic share.

So on a dynamic share basis, subcu -- self-administered subcu is approximately 35% closer probably to 40% at this point, potentially growing 3 years, 2.5 years or so before we'll be on the market for 3 years, whatever it is, give or take. So we think there's a chance that it will continue to grow. Obviously, 50% of new starts, that would double the opportunity. So we're somewhere approximately in that range. That's how we're getting to that number.

Adam, anything to add on top?

No.

And we'll go next to Michael DiFiore with Evercore ISI.

Congrats on the continued progress. A few for me. Any notable inventory channel dynamics to note in 3Q as well as gross to net changes? And also, any color that you care to offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? And I have a follow-up.

Adam, I think those both probably fall directly on you.

Yes. Yes. The first part, Michael, thanks for the question. No inventory changes or gross to net changes in the quarter. Gross to net is still within the range that we've provided. And then the second question was on subcu. Can you repeat the question on subcu?

Just any color you could offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing.

Yes. As Mike mentioned, the subcu that's in the market today does appear to be growing. They had a good quarter. And that segment of the market is overall has been growing over the last few years, probably faster than the IV market. But it seems to have settled right here, about 65-35 IV to subcu. In the future, it's hard to predict how that will change. But certainly, with more subcu products in the market, it's possible you could see continued growth in the subcu section or segment of the market. But today, it looks like things have pretty much settled out in the 65-35, 60-40 IV to subcu. It's not stagnant. It can go up and down a little bit between quarters. But that's generally where it has been and has settled out over the last 12 months -- 12 to 18 months or so.

Very helpful. And my last one is just on BRIUMVI subcu. Any update to when we could possibly see initial PK or exposure data from Phase I?

Yes. So the hope is that we'll be able to get that presented sometime in the first half of next year. Yes, I think we're targeting first half. I think the team, as you recall, I've been saying for a while, the team has been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet, but I think they're now preparing for that. So I think we'll hopefully see something in the first half of next year.

[Operator Instructions] And moving on to Emily Bodnar with H.C. Wainwright.

I was wondering if you can walk us through a bit on the ex-U.S. sales of $6.4 million and just general accounting of the Neuraxpharm collaboration?

Broke up a little bit for me in the middle of that question. But Sean, it sounds like it's -- if you heard it, it's for you.

Yes, I heard it. Thanks, Emily. So the accounting for ex-U.S. sales has been consistent since we entered into the deal with NXP. When we sell products through to them, that's recorded to product revenue. And then, of course, royalties show up on the license milestone and royalty line.

And we'll go next to Prakhar Agrawal with Cantor Fitzgerald.

Congrats on another strong quarter. So maybe firstly, any initial thoughts on 2026 trends? What could be the positives and negatives that we should be keeping an eye out for? And then secondly, I think, Mike, you talked about in the introductory remarks that about deals that look tempting. Can you talk about what were the reasons not to pursue these transactions? Was it the price or something else? And even if you decide to do BD, any details on what stage, therapeutic area or size of the deal would make sense?

Sure. Adam, do you want to tackle the first part in terms of any thoughts on '26, positives or negatives you can envision today?

Yes. I mean the things that we would be looking for, obviously, is continued growth in new patients. As I mentioned, people coming back now represent a larger and increasingly large part of our business. So the rate at which patients continue to come back at weeks 48, 72, 96 and out will be important. As I mentioned, that continues to look very strong right now and continues to drive the growth that we're seeing and better than expected. Obviously, we're going to continue to monitor and see how our direct-to-consumer efforts has an effect and impact on overall patient conversions on to treatment and whether that's continuing to work. Like I said in my prepared remarks, the key indicators at this point are very encouraging, but we'll continue to see how that plays out in 2026 as well.

Thanks, Adam. And in terms of deals, look, we've been quite candid in that we've been looking to increase our portfolio, looking for opportunities. I think we've seen every announced deal that you think is within reason of something that we'd be interested in, we've obviously evaluated and looked at extensively. I think for us, we have a high standard for ROI. We have revenue. We're using our money. We're making investments. We've got a pretty high hurdle to get over the hump. It's all about risk reward and potential ROI as we see it and as we calculate it. So I think we've got a lot of good things in the portfolio already.

Like I said, we're looking to expand, but we're not -- we don't have any desperation to do so, so we have a lot of flexibility to pick and choose what we want to do and how we want to do it and make sure it makes sense. So for us, it's all about ROI and risk reward. And I think the ones that we passed on just didn't meet the threshold as far as we see it. But like I said in the prepared remarks, we continue to look for opportunities. And if we do something, we'll be sure that we believe in it. And in any event, we're always looking to manage our risk versus the reward. It's always a very important concept for us.

And moving on to William Wood with B. Riley Securities.

Really nice quarter. Maybe one and one follow-up. I was just curious if you could provide a little bit more clarification on how, when and maybe expectations for fiscal year 2026 guidance on -- maybe not guidance per se, but expectations on where you sort of see the revenues and trying to really understand -- you mentioned that a lot of this was -- a lot of your growth was sort of pegged to maintenance. And maybe if you could just speak to what you're seeing on sort of maintenance drop-offs or switches away from BRIUMVI? And then I have a follow-up.

Sure. Thanks. Adam, go ahead.

Sure. Not to -- we're not going to get specific here on 2026 guidance quite yet, but patient persistence remains above expectations. And my comment was that, that's an increasingly bigger and will become an increasingly bigger part of our business going forward. Obviously, we continue to expect new patient growth. We continue to expect market share gains and as we continue to expand our field force and with the DTC efforts that we're having. So both things work together in driving growth over the long term.

And I think the DTC investments, as I said, remains to be seen. We're encouraged by what we're seeing so far. We're looking to optimize the investment and really refine our targeting and making sure that we're getting the right message to the right patient. And it's something that we want to continue to lean into. We'll be strategic about it. We'll be thoughtful about it, but we think it can help meaningfully into the future. It remains to be seen. But of course, we think so far, what we're seeing is encouraging.

Appreciate it. And then maybe just thinking about the Roche data in SLE from Gazyva this morning. I was curious how much read-through you may -- you sort of see in terms of that going to your BRIUMVI program? And then also if there's anything specifically from the BRIUMVI MG data that shows potential outside of MS in autoimmune?

Yes. Thanks for that, William. I actually haven't had a chance to review the SLE data very carefully this morning as we're preparing for this call. So I apologize for not being fully briefed on that at the moment. But in terms of MG, yes, I mean, CD20s have applicability across multiple indications. We think MG is one of them. We've certainly seen the CD19 data. We wouldn't expect to see too many differences between CD19 and CD20 in terms of its ability to perform in a certain indication. So we think that MG is interesting.

We've treated a handful of patients with some encouraging results. So I think there's something there. We're still tiptoeing around it for the moment. But if we dive in, we'll certainly let you know. And again, now that's part of our same risk-reward ROI analysis we're doing in terms of how we want to invest our money. So -- but yes, we do think that MG is potentially interesting for us still, and we'll keep everyone posted on that if we do move forward.

And we'll go next to Cha Cha Yang with Jefferies.

This is Cha Cha on for Roger Song. I was hoping that you can give some color on how you expect the simplified dosing regimen for BRIUMVI to expand the market share. Do you have any numbers that you can put on that like you did for the subcutaneous product?

Yes. I mean I'll jump in and save Adam from this one. I don't know that there's an easy way to put numbers on top of it. I think this is -- this one doesn't have a clearly different addressable market. So this is within our current addressable market. We do think that it's through market research that we've done that people are attracted to this and interested. And we think the enrollment -- the rapidity of the enrollment is also a clue that people are excited about this potential update to the dosing schedule. But I think it's more challenging to put numbers to it like we're able to do for the subcu, which again is really a separate TAM.

Adam, anything you want to add on top of that?

No, just other than reiterating that there seems to be customer excitement about the simplified regimen, and we've heard this consistently from customers.

And this now concludes our question-and-answer session. I would like to turn the floor back over to Mike Weiss for closing comments.

Thank you, and thanks, everyone, again, for joining us today. As we look ahead to the remainder of 2025, our priorities are clear: continue to grow BRIUMVI sales, execute on our subcu and ENHANCE Phase III trials, drive enrollment into our azer-cel program and position TG for long-term leadership in MS and beyond. Our progress to date, I believe, speaks volumes to the value BRIUMVI delivers to patients, healthcare providers and MS centers alike and reflects the dedication of the entire TG team who wake up every day focused on one simple idea, helping those with MS live better lives. I want to thank the entire TG team for their hard work and dedication as well as the HCPs and people living with their MS who continue to place their trust in BRIUMVI and TG.

Thanks again for joining us, everyone, and 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.

All right. Welcome, everyone, to day 1 of Cantor's Global Healthcare Conference. My name is Prakhar Agrawal. I'm a biotech analyst at Cantor. And for our next session, we are very excited to host the team of TG Therapeutics. And representing TG, we have Mike Weiss, Chairman and CEO. Mike, thank you.

Thanks, Prakhar. Appreciate it. Great to see you.

Yes. I mean, so obviously, you announced some news today morning as well with the share buyback, more authorization. Congrats on that.

Thank you.

But maybe to level set expectations, just sort of where you are with the launch of BRIUMVI as you look 2.5 years since the launch and the key priorities from now.

Yes. So again, thanks for having us. And yes, the BRIUMVI launch, like you said, about 2.5 years ago, February of '23, right?

Yes.

Okay, my date is right. So I mean, since the launch, things have gone better than expected. I think from internal projections and Wall Street projections, I think we've exceeded expectations in every quarter and even every year, year-over-year, we just continue to perform. So I think that's all going great, and we're super excited about it, the team has executed well.

I think in terms of priorities going forward, I think one thing the team has done great and by design was to focus on the health care providers. So the first 2-plus years has really been about educating the health care providers of the BRIUMVI, what we call advantages. What we haven't done by design was really done a lot of direct-to-patient programming. So we are now, I think, full swing into doing that. We've been encouraged by clinicians, which is great. I mean it's nice for them to ask us to do these direct-to-patient programs.

And so that's a big push for us. We have our first commercial out on TV. For those of you who still watch TV, I do, but no one else does, but we also have it on, I guess, they call it connected TV, which is everyone else is watching, apparently, the Hulu, the Netflix and everything else. But -- so it's out there. Commercial is great. My wife saw it twice last night. She was super excited. I fell asleep so I missed it, but it was great. So yes, that's going to be a big push for us. I think that would be a nice tailwind for us as we move into the rest of the year and next year.

Yes. And so on the profile, in the last 2.5 years, there were multiple attributes that you had highlighted as a differentiation when the product got launched. But what do you think has resonated most with the physician community on the profile of the drug?

Yes. I'd like to say I have a good answer as to the -- what's resonated most. I think, as you mentioned, there's a lot of attributes. I think the nice part has been there's something for everyone, right? So efficacy, as you know, in our Phase III trial, it's the only drug that in the MS class that was below an ARR of 0.1. It was actually 0.8 and 1 or 0.7 and 0.9, which implies less than 1 relapse in every 10 treatment years.

After 5 years of follow-up, we presented last year, the annualized relapse rate went down to basically 1 relapse in every 50 treatment years. So pretty remarkable activity of the agent. So that obviously is attractive to folks. The tolerability profile is something that we get a lot of enthusiasm around. The infusion for the competitive product sometimes is quite challenging we hear. And not only is it challenging during, but even after and sometimes even weeks after, and I've spoken to a lot of individuals who were on that drug are now on BRIUMVI who just have a much better tolerability of the infusion.

And again, it's 1 hour. So it's convenient to take as a 1-hour infusion. But it's also the tolerability is kind of built into that 1 hour, right? If it wasn't tolerable, you couldn't give it in 1 hour. So I think it all comes together as a package. There is -- seems to be something that people pick up on, whether it's, like I said, the efficacy, the tolerability, the convenience, all of it is -- comes together, I think, and then for those who don't think there's any difference between the 2 agents, because there are some folks who believe that. We still are about a 25% discount. So if you think they're the same, why would you pay more for the other product? It doesn't make much sense, right? You don't do that.

I'm price sensitive.

Of course, you are, and everyone is. So anyway, so yes, I think there's a lot, but not one thing I could point to.

Okay. And maybe just talk about the market right now on the CD20 market, both IV and subcu. What's the share of the -- the CD20 drugs have? And like are we seeing some sort of peak happening for the market for this class? Or you're seeing more growth? And where is the growth coming from?

Yes. So it's definitely over 50%. And in some quarters, it seems like it's over 55%. But it is -- the information we have is claims data, it doesn't cover the entire market. So it is hard to tell. It does look like it is trending northward, but it's not a linear line. I think there's definitely some variability quarter-to-quarter.

But I always -- I mean, for simplicity purposes, I think it's 50-plus percent makes it easier for me to do the calculations of market share. But yes, it's definitely trending upward. And that's the dynamic share, right? So to separate dynamic from total, so the dynamic share is about 50% plus of new starts.

And again, it could be as high as 55%. The data is not perfect. And we think it is trending northward. The total market share is not quite 50% yet, right? So that's going to take about 5 years. It's about a 5-year lag-ish between the dynamic share to the total share. So we haven't seen the total share come even close to peak. And that is the bigger part of the market, obviously.

Okay. got it. And I think last quarter, you said 1 in 3 dynamic patients for BRIUMVI in the IV CD20 class is coming over to BRIUMVI. And you have obviously highlighted your ambitions for it to be the leading drug in the class. So what do you think it takes to achieve that?

Yes. I think it's probably time. It's a competitive market. Like I said, we're approaching about 1 in 3 of the IV patients going on BRIUMVI. But it's not like the competitor is going to roll over and say, here, take the rest. So it's just time. I mean, we're in the market. We're only 2.5 years. We continue -- pretty much quarter-over-quarter, we continue to grow. We continue to capture market share.

So yes, I think we just need a little more time. I mean I talk about all the time, but 2 years ago, pretty much close to today, Adam Waldman said we're going to have nice steady growth, and he's delivered the most beautiful steady growth I've seen ever. So we'll continue to do that, and we'll continue to capture market share.

Okay. And during the 2Q call, you raised your guidance once again. Stock probably did not react that positively to the guidance raise. Maybe what's the comfort level with the guidance -- maybe just talk about the guidance philosophy in general because we get a lot of questions that -- around you're super conservative on guidance, but do you really need to be that conservative? First go through that and then I had a few questions.

Well, I think on the positive side, people understand that we're being relatively conservative. Our philosophy is the worst thing we could do is miss guidance. right? It's not that we can never miss the guidance that we're giving. But we have a pretty high level of confidence in the number we're delivering. We're not -- it's not an aspirational number, right? It's not like -- I mean -- and I didn't know this was a thing, but I've recently seen with other companies, they just throw numbers around.

And then when they miss them, they just adjust. We're not in the game of providing aspirational projections. If we're going to give a number, we're going to have a number that we have a high level of confidence in achieving. Is there room on the upside? There is. But as you've seen over the last few quarters, yes, we may be -- we may have come in -- actuals may have come in $2 million or $3 million above what we projected. To me, that's kind of dead on. It's not a precision in this business, if you really believe you have to -- there's a precision required, you shouldn't be investing in biotech. If we come in $2 million above where we came in, it's not being that conservative, right? We're pretty much dead on. And that's what we're trying to do.

We're trying to provide good clean guidance so people don't have to go off and make up their own numbers, try to do their own calculations. No one, I could assure you, there's no hedge fund analyst in this country who has access to more information to project what we're going to come up with a number than we do. And if you think that you're smarter than us and our modeling team, you're just making numbers up. And for the bosses out there who watch these kids do that, they should shut them down.

Or maybe you can hire them.

I wouldn't hire them.

But maybe on the second half trends, obviously, 3Q tends to be a little bit seasonal for the MS market. So what are you seeing in 3Q so far?

Yes. 3Q, not so bad. I mean we had -- July was another record enrollment month for us. So that was great. August was pretty much as expected, pretty slow, but pretty much as we expected. So yes, I think we had a pretty good summer, all things considered. But yes, I mean, like I said, July was a record. So we were pleasantly surprised with that. August, it's just a slow month.

For the market.

For the market, yes, I mean, no one wants to get infused in August. And last year, most people didn't want to get infused in July, but this year seemed to be a little different. But overall, perfectly good summer, similar to what we would have expected.

Okay. But is the seasonality like similar to what was seen in the prior years? Or is it a little bit different because people will start to make like year-on-year comparisons, right?

Yes, I don't know. I mean it's a summer.

The other sort of pushback in 2Q that we had received was on the gross to net being a little bit on the higher end. Maybe just talk about the discounting dynamics, what's going on?

Yes. That's an interesting question about the gross to net. So I know Adam has been really good about saying, look, it's going to range between 70% and 75% during the course of the year. Some quarters up, some quarters down within that range. And it's always about a mix of business. Probably the biggest driver is 340B hospital utilization. If they are up in a quarter, the GTN is going to be down. If they're down a quarter, GTN is going to be up.

But what I'd say is I'm not really sure what that information does for anybody, right? If we're giving you the number -- if we're giving you a revenue number target, it's the net number. What are you calculating? What are we going to use that for...

For forecasting...

Quarter-by-quarter or for long term?

Qquarter by quarter.

But why? I gave you the number. What are you forecasting? And my numbers have been pretty good.

Well, it matters, I think what the bigger picture is that matters for the evolution of the gross net. So if your gross net is increasing, you have to model accordingly. So I think that's the bigger question that how should we sort of forecast the evolution of gross to net?

Yes. And I think we've said repeatedly that for long-term modeling purposes, the net price today is probably the net price a year from now and the next year. The goal for probably every company, I assume, is the GTN goes down, the price goes up a little bit, they balance each other out. So if you're trying to figure out long-term modeling purposes, it's not unreasonable to use approximately the same net price we have today.

Okay. And as we look forward to the next year, I know it's a little bit early, but we're already sort of thinking about some of the modeling assumptions there. Anything that we should be aware of regarding, let's say, BRIUMVI's access situation than what you have right now?

I hope not. Right now, we have great access, I think, greater than 95% coverage across the country. So we've got great access. We want to do what we can to keep that access. I don't have any information that tells me we're not going to be able to do so. But yes, I mean, it is a repetitive game of negotiating with folks all the time. So -- but yes, I think we're in good shape. I think we're in good shape.

Okay. And you mentioned about the direct-to-consumer investments as well. What's the level of investments there? And what is the ROI? Like what are the early feedback on these investments?

Now that would be a good thing for you guys to model. That would be fun to figure out how you can calculate ROI on marketing advertising dollars. I know the team is working on it. It's a challenge. So it is not a number that is easily calculatable, but we will do our best, but it's too early to count on ROI at this point.

Because the DTC investments can be a little bit expensive. What's the level of investments that you're making right now?

Yes. So I don't have the exact dollar amount of the investment. It's something we can work on. I mean, obviously, it's in the -- in our OpEx, but not specified. So a fair point. But I don't know it offhand. But yes, I think we are trying to spend money on that area. We think it's important. We do gauge patient awareness. We do sort of, I think, every 6 months or so, we do a patient awareness surveys to try to see if we're kind of pushing it.

That is the ultimate goal to have a very high level of patient awareness. It does seem to be ticking up probably over and above what we would have expected through the last like 3 or 4 months. So we'll keep you posted. But that's -- to me, that's the #1 gauge is looking at patient awareness.

Okay. Got it. And on the competition, anything that you're hearing from, let's say, IV approvals or subcutaneous approvals in terms of impact to BRIUMVI?

Not that we're seeing. But to be fair, we don't know the counterfactual, right? So if subcu OCREVUS didn't exist, would we be something different? It doesn't appear, I mean, we continue to grow. We're growing at the rates and above the rates in which we anticipated. So it's hard to really see any impact, but we wouldn't know either.

Got it. And maybe just longer term here because one sort of, again, pushback that I get is what happens to the IV CD20 market when OCREVUS loses exclusivity right? And you obviously have a different view here. Just explain what do you think will happen?

I do. Prakhar has heard me talk about this a little bit, so I could see. Yes, I do have a different viewpoint. I actually view a biosimilar OCREVUS as an opportunity for BRIUMVI, not a threat. We think that compounds are sufficiently differentiated that we would not expect a deterioration of our market share. I would expect our market share to continue to grow in the face of a biosimilar OCREVUS. I assume their market share would go down and they'd lose it to the biosimilar.

But remember, we're already at a 20%, 25% discount to OCREVUS. And as you can see, it wasn't like the payers said, "Oh, well, you're at 20%, 25% discount, everyone must use BRIUMVI." So I don't even anticipate that if a biosimilar came to the market and they put themselves at a 20%, 25% discount to us, which would be about a 40% to 50% discount to OCREVUS, then anyone is going to say, well, now everyone's got to use the biosimilar instead of BRIUMVI.

So I just don't see that happening. There's only a few analogs out there, and none of them are really even close to on point. But there has been -- in the [indiscernible] setting, there was price erosion. But remember, that's a pharmacy benefit product. It's not a buy-and-bill product. There's definitely different dynamics at play. It's much harder to lower price in this setting. You put doctors and hospitals under water that becomes a problem for them.

So it's a different dynamic. So I think from a pricing standpoint, I think there could be some price negotiation at that time. But like I said, we're already at a pretty good discount to the competitor, and we'll have a much bigger base of business at that time.

Okay. And so given this sort of debate about the long-term peak sales opportunity for BRIUMVI in the U.S., any thoughts on giving long-term guidance?

Well, no one seems to care about my short-term guidance. If I gave long-term guidance, what do you think they would do with that? I mean, we are -- again, just to be clear, we're not about giving aspirational numbers. So if we give a number, we got to really feel confident we're going to make it. I think for the moment, our short-term guidance is we're comfortable that we're going to hit the $570 million, $575 million this year. And then early next year, we'll give a '26 guidance.

I think there's probably a point in time where we can give a little bit beyond 1 year of guidance. But I think I've said this many times, the modeling for this is not at all challenging. Actually, I think you understand how to model this. I think if anyone is interested in taking a look at it, someone who knows how to model, you might want to take a look at [ Prakhar's ] model.

But generally speaking, it is not challenging to model this out. The accumulation of patients is really where the market is. Like I said earlier about dynamic share versus total share. The dynamic share, the dollars in the dynamic market are a fraction of the total market. And anyone who's trying to model just from dynamic share, what the peak is are not understanding the model in total share. But anyway, so we're not going to give long-term guidance, but I don't think it's challenging to figure out from where we are today.

Okay. Maybe on to the pipeline. Obviously, the subcutaneous BRIUMVI is an important piece of the story. In 2Q, you noted you're testing -- you will be testing both quarterly and every other month dosing in pivotal trials. What are the key risks as you move into pivotal trials? Because we haven't seen the data, but should be straightforward PK data that you would have seen. So maybe just walk through as you move into the pivotal trials, what should be the expectation?

Yes, absolutely. So the study -- we'll start with the study design. So relatively straightforward. It's a bioequivalence PK, non-inferiority area under the curve. If you've looked at the OCREVUS subcu trial, you pretty much have a good sense of what this trial looks like. The difference is we're taking 2 dosing intervals forward every other month and every 3 months. So at least we'll have a good look at a little bit of a dose response and understand the kinetics of the bioavailability.

The data we have from Phase I, yes, it's short-term bioavailability information. From that, they can model out what they think the bioavailability is. There's a pretty decent range around that. So the confidentiality around that number is still relatively wide. But I think it would have to be outside the range probably for the every other month to fail. And every third month, we think, is in the range of reasonable possibilities of being successful based on what we know about the PK today.

Okay. And can you talk about the device presentation that you're aiming for and the injection volume versus what your competitor has?

Yes. So there's 2 subcu. For those of you who can't see, I'm making hand quotes. So Kesimpta is a true subcu, auto-injector, put it on your body, hit the button and in 2, 3, 4, 5 seconds, I don't know exactly how long, but it's relatively quick. You get your dose. The OCREVUS subcu is a 20 ml plus, may be 21 ml product. In an auto-injector, typically, you want to be 2 mls or below. Ours is going to be -- ours is designed to be in an auto-injector at 2 mls or below of material. So it's a different product from subcu OCREVUS, much more similar in terms of the Kesimpta-like profile. Like I said, every other month or every third month, and it should be a relatively rapid subcu auto-injector product.

Okay. And on the subcu OCREVUS [ spleen ] and the injection reactions was a little bit of an issue and, I think, at least based on the early feedback, still an issue in the real world. So is that driven by just the injection volume? Or like how would you characterize BRIUMVI's subcutaneous tolerability profile?

Yes. I mean, typically, the pain injection site is volume to time, right? So theirs is a 10 to 15-minute-ish subcu push. With an auto-injector, it's going in seconds, you're putting 2 mL. But again, it should be -- I mean, you could have injection site reactions. It's -- but it is -- there's nothing to extrapolate from the OCREVUS subcu experience. I think looking at the Kesimpta experience would be a much better analog to assess what you might expect for injection site reactions and any other basic reactions of that kind of a product.

Okay. So how big of an opportunity is it for the subcutaneous formulation right now? And is it like just incremental? Or do you think that this is a major opportunity for the BRIUMVI franchise?

I mean, I guess it depends how you define incremental.

$500 million.

Well, you can do it in dollars, that's one way, or you can do it in percentages. So right now, the subcu marketplace represents 40% of the CD20 market, right? So that's about another 75%. It's not quite double the market opportunity, but it's about 75% of the original opportunity. So for ease of conversation, it's almost double the opportunity. So that's incremental, we'll call it incremental. To me, that sounds a little bit more than incremental, but it's almost double.

Okay. And maybe in the interest of time, I did want to touch on a couple of other pipeline opportunities. Azer-cel in primary progress of MS, I think started dosing patients as well. Maybe just talk about the experience there. And obviously, the Street is not giving much value to the asset right now, but you have some long-term plans there.

Yes, that's okay. I can't ask for value before we do much with it. So I'm not upset about that. I think that's fair. But yes, we're early. We're building momentum. I would say, pretty confident we're going to see a lot more enrollment in '26. '25 is definitely a year of just getting the system in place. I think the -- it was -- it's a struggle to put these sites and get them up and running. But once you get them going, and we get the system. So I think the system is about to turn into a machine that works properly.

And yes, so my fingers are crossed that we'll have good enrollment in '26. Primary progressive is the first indication. But in '26, we'll have another, I think, 4, 5, 6 indications open, and we'll have another bunch of centers open. So things should start to turn. But right now, it has been a little bit slow, but I do -- I think theoretically, I do really like the product.

I believe in CAR-Ts for autoimmune diseases. I think there's an application there that could be pretty amazing, whether we have it or not, I hope we do. I think we have a good chance at it. But I think there's room to build on that opportunity.

And maybe on capital allocation, you did announce a new share buyback authorization of $100 million. You did a lot of that in August, I think $70 million or so. Maybe just talk about why you sort of did it right now and the pace of share buybacks over time?

Yes. I mean, look, we were -- as you can see, we announced $100 million buyback last year. And over the course of 11 months, we bought back about $20 million, $25 million-ish over that time period. So I think the pace was moderate. We were just in the market buying pretty much every day, reasonable amounts of shares. We weren't aggressive. When the stock dipped into the 20s, we just saw a great opportunity to take advantage of that.

So we loaded up and finished it off. We put another $100 million in place. And we think if there's another opportunity, we'll buy aggressively. If not, we'll just slowly buy every day. I mean, at these levels, whether it's in the 20s, clearly, we don't believe that it's reflective of the true value of the product. In the 30s, still way undervalued, but we'll just -- which is why we'll continue to buy. We're not like aggressively spending the money because we're still waiting for the big cash flow to start hitting, which will be soon enough. So we'll take our time. But any time we see a major dip, we'll just -- we'll be aggressive for sure.

And you talked about meaningful cash flows. I think, obviously, 2026 onwards, that will start coming in. Is BD part of the long-term strategy here and maybe some major BD because obviously, the cash flows is pretty predictable and easy to forecast, as you mentioned.

Thank you, Prakhar. Yes, BD is definitely a big part of it. We've been very actively evaluating opportunities. We have not pulled the trigger. I think we've been very cautious about what we will do and what we have done, what we've done. Like I said, we didn't -- all we've done recently is azer-cel that was, I think, at least 2 years ago now, it was 1.5 years. But we're actively evaluating. We're building out our BD resources.

And our goal is to be active, but I don't -- when you say major, I don't see us making major acquisitions. I think there's a lot of opportunities for us to build without having to spend a ton of money upfront. I mean if we have to, I think there's ways to do that efficiently, too.

But is the focus more late stage, early stage?

Yes. I mean, early, mid-stage is kind of where we're most comfortable. We feel like we're -- the first phase of the launch, we'll call it, first major phase that has multiple little subsectors is through '28 to mid '28 when we start to launch subcu, then we have the subcu launch. So we're busy. We don't have -- we have to build new teams. If I wanted to acquire a commercial product today -- again, those things are numbers also, right?

So if there's -- if I could buy something that's reasonably inexpensive and we could turn into something special, of course, we would do it. Those things don't grow on trees in that way. So not ruling it out, but not saying that's the target, and we're only focused on that. But other than that, the team is busy. They've got a lot of work to do. They've done a phenomenal job thus far, and we're seeing -- continue to believe we're going to do a great job going forward.

All right. That's all the time we have today. But, Mike, pleasure as always to chat with you. Thank you for coming and thank you to the audience for listening in.

Thanks, Prakhar. Appreciate it. Thanks, everybody.