Hi, good morning, everyone, and welcome to TD Cowen's I and I Summit. This morning, we have a fireside chat with TG Therapeutics. My name is Tara Bancroft, and from TG, we have Michael Weiss, the CEO. Thank you so much, Mike, for joining us today. For everyone who's listening, please send me questions either via the panel link that you should have in your invite or my email at tara.bancroft@tdsecurities.com. I'll do my best to get them asked before the end of the chat, which is very brief, unfortunately, today at 20 minutes. You know, I think with that, we can just dive right in. I think it obviously makes the most sense to start with IV Briumvi. You guys have had a pretty impressive few years with this launch. I think it would be helpful to start maybe with some physician feedback that you've been hearing recently, you know how that's changed and evolved over time, especially now that it's so well established on the market now. It's become a very trusted product. You know, what is it that makes physicians reach for this versus other options? Yeah, first, thanks for having me. Appreciate it. Yeah, I'm on the road this week. That's good. I have some fresh perspectives on clinician feedback. So far, what I'm hearing is most folks have moved Briumvi into the first IV slot. I think a lot of it is around the data, the convenience. Is the audio not working? No, it is. Oh, OK. Sorry. Sorry. Yeah, I think it's surrounding the patient convenience. Site convenience is a big one. I think a lot of the data, the five-year data, six-year data actually now has been super helpful. Seeing the long-term data, folks definitely appreciate us following and giving that data out. A lot of it is around patients who have issues on the other drugs. We see a lot of crossover patients. That's been a big one. Recently, we just moved up to one of the academic centers I'm visiting here to their number one IV because we have the most generous patient support programs. The other two companies have cut back dramatically on their patient support. Don't know why, very unclear, but we've just maintained the same program we have, which has now made us the number one patient support program. That's been really well received by folks. I think it's a compilation. I think part of it is just time on the market, people just getting more comfortable, and continuing to have good positive effects with the drug. Yeah, OK. That makes sense. Hearing that you're on the road, you're boots on the ground yourself, too. Curious to maybe hear a little bit more. You did mention that you're increasing share in the crossover patients. Maybe can you give us an updated kind of breakdown of new versus crossover patients and switch and how you're going to focus on each segment going forward, like which one is going to be the greatest priority and what kind of challenges do you maybe expect in each of those segments? Yeah, so we have changed our initial posture, which is if someone is happy on their current treatment, it's really hard to get them to change. We don't expect people to do so. Our original hypothesis when we got into this was that we're going to be battling for new patient share. Now, of course, new patient share for us does include people who switch from other CD20s as well. We really believe in focusing on the new patient share. Having said that, from the very beginning, we've said we've had a pretty large proportion of our patients who are CD20 switches. It's been relatively stable. I mean, we've talked about it in three buckets. We have naive patients. We have patients who switch from other therapies that are not CD20 and the ones who switch from CD20. It's been relatively those buckets haven't changed all that much almost from day one, which is pretty remarkable. The way we've described it is the switches from other therapies is the largest group, but it's not much larger. None of them are more than 50%, and none of them are less than probably 25%. You can reign the pretty range bound, the middle bucket being the largest. Second would be the switches from other CD20s. Again, we see a lot of that happening. I think one thing that we're probably going to work a little bit harder on is to get more clinicians to check in with the patient whether they are actually happy on their other CD20. I think there's a lot of folks who, if the patients aren't aware of an option, and we're doing our best, and we'll talk a little bit more about what we're doing to get patients more aware of new options. If a patient isn't aware of a new option, they're not going to complain about what they're on because they're just happy. I mean, it's probably providing the activity they're looking for, but whether they're having some sort of tolerability issue, whether it's the infusion itself takes too long and it's sometimes a little too painful, it takes hours and they have to stop and go. Other folks will actually experience days to even weeks of feeling poorly after their infusions. I think we can do, we will. We're going to try to do a better job. We're trying to get more clinicians just to ask the question. I think they're going to find that there's more people who are somewhat dissatisfied and may want to seek another option. For those who are happy on their current therapy, we assume they'll stay on it, of course. OK, great. All right, so then moving to, you announced a very impressive enrollment rate in the enhanced trial that combines the initial doses. Maybe just a little bit more on what you think a successful data set looks like there and how you think that that could impact maybe growth rate of sales once it's included on a product label. Yeah, so what we're looking for there is actually similar to the SUB-Q study and area under the curve measure. Assuming that there's no difference in area under the curve, that will be a successful outcome for that trial. In terms of impact in the marketplace, it is hard to measure because it's the same market that we're currently in. Like I said, I'm here on the road the last few days and going forward a few more days. People are excited about it. Yesterday, I got a very enthusiastic, that's going to be really impactful. In fact, it was around the switches. They were excited that it would be a one-dose switch in the label versus doing it off-label, which some people do today. On-label one-dose switch was definitely positively in that particular meeting. Overall, we've had very good feedback. I mean, the concept of having to just come in once to get started is helpful for the patients. Obviously, for sure, no one wants to come back for another visit if they do not have to. That is nice. Two, for the centers, it can get the patients in faster. One of the biggest problems with scheduling is being able to match up the two doses two weeks apart. You will find that it takes sometimes could take one to two or three months even to get a patient scheduled where they can get those two blocks put together properly. That is going to simplify that. We think that will speed up the time to start, which is a big deal. I do not know that people talk about it much, but it is a big deal. We may talk about this later, but that is one particular reason why Kesimpta and the SUB-Q has actually taken the market share it has. Part of it is it's just you get the patient on quickly. That is not the case right now with some of the IVs. Yeah, I think that'll be a big help there. OK, great. I want to get into maybe some revenue expectations and initiatives for Q4 and next year. I think a good next place to go would be maybe some competitive dynamics, maybe any thoughts and feedback you're hearing on the use and uptake of Ocrevus de novo. Of course, after that, I would love to get your thoughts on fenebrutinib and Roche's success there in that trial, both trials. In terms of Ocrevus SUB-Q, we're just not seeing an impact in the marketplace today. I mean, I assume they talk about it in their calls. I've listened the same way you guys. From that standpoint, I hear what they're saying. In the field, we're just not seeing much of it. I mean, we do know there's a handful of centers that we know well are using it, but not with much impact on how they use Briumvi. Certainly, in the vast majority of other places, we just don't see the impact or the utilization, really. Yeah, I mean, we'll see how that evolves. I know they're obviously working hard to improve their uptake. Good luck to them. I think we're in a good position and not too concerned. I think that's all I could really say about that. It's all I really know. Yeah, that makes sense. Any reaction that you have to the announcement of the fenebrutinib, the successful trials in RMS and progressive MS? What do you think about the dynamics of the market playing out if, and I guess, or when the BTK inhibitors are approved? Yeah, so I'll start with the first principle, which is before any of the failures in the BTK, my position was that this was based on talking to clinicians, of course. My position was that it's going to be an oral product. It will fit in the oral category. Half of patients today will go on to a non-CD20 option. My assumption is it's going to compete more in that category than it will compete against a CD20. I just think the convenience of an every six-month infusion or a SUB-Q at home, it's just when we talked to clinicians about bringing our BTK into RMS, most of them said, why? Why would I use that instead of the infused product, which I know they're going to get? Compliance has been a huge problem for orals. They still get used, but it's just been a huge problem. Again, I think if you want someone to get a high-efficacy therapy, you're going to encourage them to use one of the IVs or SUB-Qs. I think that's still how I feel about it. I think, look, I kind of would have hoped that the BTK would have been better than Ocrevus in primary progressive MS. I think the hypothesis was that it would be. That was certainly the hope. I think most clinicians don't really see much activity of Ocrevus in PPMS. It's approved. They're just not seeing a whole lot. The term I heard with a big academic center that I saw two days ago was that Ocrevus theoretically works in PPMS. By the transitive property, I guess BTK theoretically works in PPMS. I don't think it's a, I mean, it'll get used because why not? Although, again, I don't know why they would switch off of Ocrevus to use it. I think the outcome of that study, I mean, we'll see all the data. I think, obviously, all judgments reserved until full data are revealed. I would have assumed that we would have seen a step-down statistical analysis of superiority following non-inferiority if they had succeeded. There's no alpha used to do that analysis. I did not see anywhere in the press release that they did the step-down and showed superiority. I assume that they did not. Again, we'll wait. I have to wait until we see the full data. The other thing I'll say on RMS, look, we've had three or four failed RMS studies with BTKs. If you think about how these studies are powered, you're going to expect at an 80% power one in five or 90% power one in 10 studies will be false positives just by chance alone. We're into this thing. They got one more RMS study to read out. I'm not saying it's going to fail, but I wouldn't say it's a 100% guarantee that that study will read out positively. OK, very interesting. Yeah, we also really look forward to that data. All right, interest of time, let's get to maybe a discussion of Q4 expectations. Maybe you can tell us a little bit more about any headwinds or tailwinds that you expect throughout the rest of, I mean, throughout the entire Q4 and just to get an idea of your level of confidence and whether you can meet or even exceed your stated guidance. Yeah, so over the next, I guess, 48 days-ish, 49 days. Yeah, I mean, look, I don't know about any headwinds. Fourth quarter, usually, there are just general dynamic tailwinds. It is usually we did guide to better growth in 4Q than we did for 3Q. That has been our experience. I mean, we're approaching our third year of sales in about three months. From our experience of that limited nature, we do see that the fourth quarter has some positive dynamics that come into play. I think we're comfortable in terms of the guidance and can we meet or exceed it. The team is well aware that I have little tolerance to fail to meet a guidance. It is not that the guidance we provide cannot be failed. It is that if you kind of look at a normal distribution curve, it is not a normal distribution curve. It's probably skewed with very little to the left and a little more flexibility to the right. It is the best number that the team believes at the time that they give me the number that we will see. And if it's a range, it's the best range that they can provide me. They do know that it should be very little left-tail risk. It's not zero, so we could miss. Ideally, it's set up so that we should at least meet and potentially exceed. Again, I know people, we've pretty much successfully met or exceeded the guidance we've given, never by a huge amount, to be clear. It's not like we're gaming the system. I mean, if we come in a million or two over, I don't really consider that a major change, right? I think we're in a good place. I don't know what the exact number will be at the end of the year, but I feel like we're in a good place to meet or exceed those expectations. OK, great. How about maybe a little bit about 2026? What are some of the things that you guys have planned to maybe accelerate growth to some extent next year? What kind of cadence can we expect throughout 2026? Yeah, so we tested our DTC campaign. We've had our TV commercial. I guess I'm the only one who watches TV anymore, real TV. I know that there's a few versions of TV these days. We were out there with our commercial. I think it's hard to tell, but the team believes that it is helping in raising awareness. I will say, again, on the road this week, I did hear that patients have come in and talked about the commercial and asked for the drug. That is an extremely positive benchmark for us. They are listening to that last line, talk to your doctor about Briumvi. We like to see that. We're going to probably lean into that a little bit more in 2026. I think we're going to expand and grow that program. What we have been doing on the field team side, we will continue to do. We continue to evaluate where our strengths are, where our weaknesses are in the field, and adding where we see weaknesses. We do not have a plan where it is like, OK, we are going to go from 100 to 200 to 400. We evaluate this territory versus this territory and see if we think we have room to add talented folks. We have the team in place. It is phenomenal. I think they have done a really amazing job. I get nothing, again, I keep saying it, but I am on the road, nothing but compliments about the team. My joke is I walk in, I always ask if just tell me which person on the team I should fire. We will replace them and get you someone better. So far, no one's taken me up on the offer. The team is phenomenal. There are still places where we could add additional folks that may have better connectivity than we currently have. That's how we look at it. That's what we're going to do this year as well. We'll be adding to the team, and we'll be adding to the DTC this year. OK. Yeah, by the way, I appreciate the use of the A-ha song. It's a great one. OK, I know we are running out of time. I do want to be able to get to SUB-Q a little bit. I know, I mean, you guys, again, you have this pivotal trial. It's a really efficient design. Can you maybe tell us a little bit about what success would look like in final data from that, maybe a timeline on that too? Yeah, yeah, so relatively straightforward. We're looking for a non-inferiority area under the curve for each of the SUB-Q arms versus the IV arm. I mean, the hope is that both are successful. I think we're in a good place to deliver that, but no guarantees until the study is done and reads out. We're feeling good about the program, about that yet. Just to be clear, we have two doses being studied versus IV. We have an every other month and a quarterly dosing regimen. Like I said, both of them, the goal is to prove that each one is non-inferior, judgment area under the curve. I'm sorry, there was a second part to that question. I think you must have got timelines. Timelines associated, yeah. So we're hoping to have enrollment complete in the first half of next year, data probably the latter part of the year or early 2027, and then looking for filing probably second half of 2027 and targeting approval in the second half of 2028. OK, great. And then kind of similar question about competitive market dynamics here. I mean, how do you see it really fitting in with Kesimpta, with Ocrevus de novo, with IV Briumvi, all the other IVs, and with competing potential from BTK inhibitors? What kind of potential are you seeing here at peak for your subcutaneous version of Briumvi? Yeah, we think it's pretty large. The dynamics in that marketplace are pretty good setup for us. It's basically an overlapping client base. What I will say is that the threshold question when a clinician decides that a CD20 is the right treatment for the patient, the threshold question is, do you want to inject yourself or do you want IV? So it's pretty easy. It's a competitive. Right now, there's a monopoly on if you say SUB-Q, you want to self-inject, there's currently a monopoly of one. We'll be competing only against that product. The Ocrevus SUB-Q is a physician-administered product. We're already technically competing against that product in the physician-administered marketplace. Obviously, I think we're doing quite well. Yeah, so it's a completely greenfield market for us. I say it's almost double the total addressable market. It's not quite double. We think it's like 35%-40% of the overall market. It's getting pretty close to doubling the TAM. Yeah, we think we're going to do great in that market. We've got a lot of our centers like working with us if we can come in with the quarterly with a little extra convenience. Even if it's every other month, and we know that Novartis is working on every other month product as well, it's fine. We're going to be in that market. We're going to use the same way we've done before, which is great product, great people, great service. It's worked out pretty well so far. We believe we'll continue to work in the SUB-Q marketplace. OK, great. I know we're already over time, but I really do want to give you the opportunity to talk about the rest of the pipeline that you have going on. You have this MG trial, azer-cel. How are you thinking about prioritizing amongst the pipeline in also trying to drive the commercial franchise? Yeah, so it is an ROI calculation for us. So we do NPVs on everything. But clearly, the investment dollars first go toward Briumvi IV on the market, second dollars SUB-Q and SUB-Q on market when we get there. In the meantime, yeah, I mean, we have small programs today potentially growing for MG, which we have not fully committed to yet. We have been tiptoeing around it. We continue to tiptoe around it, but we will keep you posted if we make that dive in. So costs today are low. If we did jump into it, yeah, it will certainly add some cost to our R&D line. Besides that, and then azer-cel, unfortunately, we are gated in how we can enroll into that trial. It has been relatively slow. I am hoping that sometime maybe by the middle of 2026, we should have most of the gates down and we can open enroll, and that would be great. It is still early. It is still exploratory. I think both of those programs I would describe as very interesting, exciting, but exploratory. Maybe during the course of 2026, we can have a little more clarity on what those will look like in the future. As we sit here today, unfortunately, I just have to remain optimistic but cautious. That makes sense. OK, I look forward to that the rest of this year into next year. With that, I know we're several minutes over, but I really appreciate you taking the time, Mike, and everyone for joining us. Thank you, Tara. Appreciate it.