Tg Therapeutics, Inc. (TGTX) September 2026 Conference Transcript

Good afternoon, everyone, and thank you for coming to the H.C. Wainwright 28th annual Global Investment Conference. My name is Emily Bodner, and I'm an equity research analyst at H.C. Wainwright. I'll be doing a fireside chat with Mike Weiss, chairman, president, and chief executive officer of TG Therapeutics. Maybe to start, can you set up for us the current landscape in relapsing multiple sclerosis and where your commercial asset, Brion V, fits into that landscape compared to other anti-CD20 antibodies? Yeah.

Good to see you. So, you know, for relapsing MS, we estimate that there's approximately 40,000 new patients per year. Actually, that's for all MS, so RMS and PPS, RMS, RMS confirmed 40,000, about 40,000 a We'll go on to a CD20, so that's in a given year. about 65% will choose an IV option and about 35% maybe it's 60 65 30 35 so it's like 20 30 35 percent for a sub q option and 65 70 percent for a IV option today there's just one sub q option so it's a market that we don't currently participate in and we participate and compete in the IV market which includes Both our IV product, another IV product, and a, I guess, a sub-Q, physician-administered sub-Q, which we consider to be, since it's a physician and office-based, we view that as part of that competition. Right now, I don't have the exact numbers, but we've been tracking over a third and growing of the IV portion of the market. So things have been going quite well. We will complete our fourth year of on-market as of, I guess, February, about February 1. So I think we've done an incredible job of breaking into a very competitive marketplace. I think that's probably the RMS market, just generally speaking. It's probably a good start there.

Brionby, obviously, has done very well. you've kind of beat your guidance pretty consistently, and in 2Q, you updated your guidance to 890 to 905 million. What metrics are you kind of estimating to go in that, and is there a bit of conservatism in that guidance?

So in terms of the metrics that go into our projections, so probably the two biggest will be new patient starts and persistence, But what's interesting, over time, persistence becomes probably the biggest variable because, you know, we estimate from a competitor product that the median on CD20 is about five years, right? So after a number of years, what you notice is that the repeat business becomes a bigger portion of every quarter, right? So you can only, only a smaller portion is going to be based on those new starts. So persistence and new starts, those are the two biggest variables that we look at. Gross to net changes, so mix of business, will have an impact. Remember, again, as that GTN goes across a bigger installed base and repeat business, changes at GTN can have some material impacts. And they are, I mean, just to be very clear, GTN does fluctuate quarter to quarter. And so that will have some impact, and there's just natural variables that change that GTN on a quarter-by-quarter basis. Those are probably the biggest three.

There's a few other variables that will go into it, but I'd say those are the biggest Maybe walk us through the second half of the year, how we should be thinking about revenues and any seasonality or gross expectations for the remainder of the year.

Yeah. So the nice part of the second half of the year does benefit from improving gross to So the first quarter, if you talk about seasonality, there's seasonality in both gross to net. There's seasonality in terms of those 40,000 dynamic share patients. So one is the first quarter of the year is usually the lowest GTN. And then it typically will sort of slowly climb during the course of the year. you get a little bit of a tailwind from from dtn gtn changes uh whereas uh you also have in the summer you probably have the lowest portion of that 40 000 right so it's not a linear it's not 10 000 10 000 10 000 10 000 it's every quarter is slightly different and certainly the third quarter is going to be the one that has the smallest dynamic market available but again you get some benefit from from the gtn so those things sort of uh hopefully balance each other out in some some proportion some way and as we've said you know based on the call we're looking for ending the fourth quarter with over a billion dollar run rate which is what we're really been focused on and targeting so we're pretty excited about that that'll be a big milestone for the company maybe walk us through the dynamics of new patients going on Brion V is it all newly diagnosed patients or do you have patients who are switching from Ocrevus or Casimta and has that dynamic changed over the years yeah so that's that's really interesting and I do have some fresh information on that so it's not like it's not MMPI but information but we've recently did a new look and we have some I had an original look that was like six months into launch and the pretty interesting part two two pieces that are interesting one of which may be obvious one of them may not be as obvious so the one that may be obvious is that the proportion of truly naive patients has grown over time right so you can imagine you launch a new drug maybe the newly diagnosed patients are the ones you're not going to put it on immediately and you'll put on sort of later stage patients that proportion has grown over the last two and a half three years since we since our first data the one that might be surprising is that the proportion of patients coming on from other CD20s has basically not changed. It has been very consistent. And in fact, at this point, almost these three groups are almost equivalent. And I say three groups, and we only talked about two. So one group is truly naive. The second group is coming from something other than a CD20. And then patients who come to us from another CD20. And those groups are essentially equivalent now i think in the past i've described them as um you know a little bit imbalanced pretty equal but not they're really much tighter today than they were but like i said the distribution has been more naive which has outpaced from transfers from other treatments but the cd20s switches have really maintained rock solid uh since we started which is pretty amazing quarter over quarter walk us through how uh it's decided what therapy patients will go on within the n2cd20 class is it more patient driven formulary driven physician driven yeah it's it's definitely an area where shared decision making is quite popular um so once once the clinician decides that the CD20 class is right for the patient, pretty much the threshold question they will ask is, would you like to self-inject or would you like to come in and get an infusion? And like I said earlier, about 30%, 35% are taking them up on the offer to self-inject and the remainder will go on to, will choose an IV. Once they choose an IV, then the clinicians We'll usually give them information about both of the IV products, and we'll typically send them home, give them some time to think about it, and when they come back, they have another conversation about which CD20 they'd like to go on.

As you're approaching that $1 billion sales mark, likely next year, how are you kind of thinking about peak revenues for Brionvy in the IV market? it? How do various dynamics like Ocarus patent expiring in 2028 and other factors kind of play into that?

Yeah. So I've said both on a conference call, not the last one, but the immediately prior one. I think I said it last week again. I mean, the way we're reviewing, we haven't given a peak number out yet. And I think the team is probably reserving at least until we have all the pieces of the sub-Q put together. But for the moment, what we said publicly is that we feel that the IV market is still at the early phases, that we believe it could be multiples of where it is today, and that the opportunity in sub-Q is at least as large, if potentially even larger, than the IV opportunity.

So I think that sort of gives at least a little bit of a framework of what we're thinking about true guidance is yet to be given and then there was a second half of that question okay okay maybe on the flip side talk about the XUS commercialization how that's been growing recently and you have your partnership with Nurex farm has kind of been growing yeah so they They seem to be doing quite well.

I think they're doing as well as we would have expected, if not better. You know, again, it's probably a more challenging market than we sit in here. So I think we give them a little credit in terms of how well they've done in that marketplace. SubQ there is, I think, by category is the largest contributor. So whereas here it's 30, 35 percent, there I believe it's above 50 percent of dynamic So again, given those kinds of dynamics, I think they're doing a nice job.

And you recently had data from your enhanced trial, which was looking to combine the first two doses into a single dose. How are you kind of thinking about practical benefits with that shift in administration, and how do you think that that could play into growth in the IBE market?

Yeah, so, you know, that's interesting. When we started that program, we definitely wanted to, I would say, make it a little easier to get onto Brionvy. I don't think there's any surprise what we were thinking. I think what's different than what we originally thought was the impact. You know, we've done both what I describe as qualitative research, or discussions with clinicians, but also quantitative research. And both of those have surprised us in the potential impact that this change could have. I think people are really much more enthusiastic than we originally anticipated, both from the patient side, the clinicians believe obviously that bringing them back twice in the first two weeks is fine, but if you don't have to, it's much better. And then from the practice, you know, we've always heard this comment from the practice, like, that they're playing Tetris, trying to schedule the two visits and fitting them both in. And when they heard that we were consolidating the dose, they just seemed to get really excited about that's going to just simplify everything. So, yeah, we're pretty excited about it. We think it's going to have a nice impact on our growth in 27.

Maybe just touch on where you are with getting that supplemental PLA update for that trial and timing.

Yeah. I think we're working very hard. It should be imminent.

Okay. You're also, as you mentioned, developing a subcutaneous formulation of BRIOMV, which you recently shared phase one data for. Maybe talk to us about what you saw in the phase one with exposure and bioavailability and how that kind of gets you confident with the phase three coming up.

Yeah, so obviously we're very excited about that sub-Q. I think we've been pretty vocal about it more recently, especially since we put out that information. So just circling back, so threshold question is, do you want to self-inject or not self-inject? and about 30-35% of the market we're not participating in. So we do see this as a material increase in market potential for Brionvy. The data that we presented was phase one, but it's not a small data set of, you know, this is bioavailability information. I think we had approximately 90 subjects that were in that study. They're all MS patients. Actually, some were MG patients as well. And we basically demonstrated that it's a little over 60% bioavailability. The confidence interval is relatively tight with the 90 patients, so we're feeling good So again, it should be reasonably straightforward from here. We have a, we've talked about our sub-Q injection, which is basically a concentration of 200 milligrams per ml. We're delivering basically in 400 milligram mL, so two mLs, 400 milligrams. We're dosing two schedules. Again, when we first started, admittedly, the bioavailability looked at a little bit lower in the earlier patients, and we designed the phase three with the utmost caution. So we have a group that's getting dosed every other month and a group that's getting dosed every three months. Based on the bioavailability information that we have from the phase one, the modeled result for the phase three would be about, I think, a 1.23, which, just to give you a sense, if you have a one, it means that the concentration measured by area under the curve is exactly the same for the two. The FDA standard is 0.8 to 1.25. Particularly in these cases, it's the bottom. It's a non-inferiority, so you can't go below 0.8. And so, like I said, I think ours comes in about a 1.23. So we're in a very good position. That's with the quarterly. I could say with the every other month, it's higher than that. and many drugs, particularly antibodies, they will go well over because there's typically not a dose response for toxicity or for activity for that matter. There's pretty much you hit a threshold for both and the more antibody you add, you don't really see much additional benefit or safety concerns, so most people do go over the top. But we should be pretty darn tight in that range, so we're feeling really good about it. And that data should be available, you know, end of this year, early next year.

Based on what you just said with the every three-month dosing, how do you think that kind of stacks up competitively versus Casimda and also Ocrevus, which is also developing a similar kind of on-body administration?

It's hard for you to say it without laughing, so I get that. I'm going to – I'm not going to – anyway, Anyway, so how do I think we compete? I think an auto-injector pen that delivers in approximately 10 seconds every three months is a highly attractive proposition for patients. I think that Kesimpta is currently at once a month. I know they're trying to improve that to every other month, so we'll see how successful they are with that program. but I think every three months auto injector is a very attractive profile and yes we are aware that the competitive product the competitive IV product which is now also given as a sub-q in the office has plans to try to convert every single one of those patients from the office sub-q to an on-body injector at home all we know is it should be every six months with their plan, and we've heard that the volume will be lower, but right now their volume is, I think, 23 mLs, and it's unclear how much lower they're going to go, but that's a pretty hefty sub-Q compartment.

Okay.

I'm going to ask this only because we get a ton of questions about it, but do you feel like the the oral btk inhibitors will have any impact um on the anti-cd20 market um or is that kind of going to be like a separate segment of the market yeah i mean i think the answer is minimal i think it's primarily a separate market um but they'll be there's always going to be some bleed over but i think generally speaking uh about 35 when we talk about uh the dynamic share which i I didn't give the percentage, but right now, CD20s, I think, represent about 50-55% of the dynamic share. So a new patient, well, a patient starting a new therapy, whether they're naive or coming from something else, about 35% of those will go on to an oral, right, 50-55% will go on to CD20, 35% on to an oral, and then the remainder go on to, well, most of those go on to Sabri, but there are still a portion of patients that go on to platform drugs, which I find pretty insane, but it happens apparently out there. But anyway, so in that 35%, I think there is an opportunity for a novel oral therapy that can provide good control of the disease. So I think it has its own set of challenges, right? It's twice a day. It's in a highly genericized marketplace. So how it breaks in is yet to be determined. But I do think there's room for a novel therapy there.

Makes sense. Maybe for our last couple minutes, you also have trials ongoing for other indications, like myasthenia gravis, and you recently announced the treatment-resistant schizophrenia trial. So maybe just touch a bit on those and how CD20 plays role in those diseases?

Yeah, so with one of the diseases, CD20 slash CD19 is a pretty well validated treatment option. I think what we're trying to contribute to that area is potentially a new paradigm of how you treat those patients. So today, one of the major treatments is using anti-FCRN therapy, and they're basically pulsed treatment. You get a weekly injection for four weeks, or one of them I think is six weeks, and then you stop, you wait for the symptoms to return, and you retreat. So they have very rapid symptom relief, but then you wait for them to relapse, and we think that a more interesting way to approach the disease would be not to put people through those continuous cycles of also of weekly treatment, or every other week and potentially I think they're working on, but this would be, you'd give them four weeks of FCR and therapy, you'd get them into a symptomatic remission, let's call it, and then you'd hold it there using Bri-en-V, probably quarterly with sub-Q. So that is something we think is really interesting, and not only if it works here, there's other diseases where you can import that to. And so we think that's a treatment modality that can be used in other areas. And then schizophrenia is one that's no real proof. There's a small group of patients that were treated with rituxan with good results, but the biology is, I don't want to say screaming, but certainly pointing in the direction of a neuroinflammatory component to schizophrenia and a number of other mental health disorders. So again, we think that if we can prove that you can dampen that neuroinflammation and improve symptoms for patients with schizophrenia, that could be translated to other mental health diseases as well. So we think both of those have really both direct impacts on the current diseases, but also broader implications.

Maybe to close out, if you can kind of give us a summary of upcoming catalysts that we should be looking out for for the next 12, 18 months?

Yeah, so I think we've got a pretty catalyst-rich next 12 to 18 months. So I guess first up will be, you asked about the supplemental BLA. So for our enhanced or simplified dosing, probably before we have the phase three data for sub-Q, we should have some Azercel data at ECTROMs, then the pivotal phase three data for sub-Q, and then into 27 hopefully launching of the enhanced protocol along the way I'm assuming we'll have some schizophrenia information hopefully sometime in 27 and then that will lead us into the 28 approval of sub-q all right thank you Mike thanks everyone who's been listening in hope everyone has a great rest of Thank you.