Hi, everyone. Thanks for joining us at the H. C. Wainwright twenty seventh Annual Global Investment Conference. My name is Emily Bodner, and I'm an equity research analyst at H.
C. Wainwright. Pleased to introduce, Michael Weiss, who's the chairman, president, and chief executive officer of TG Therapeutics. We'll be doing a fireside chat. Maybe we can start by you kind of setting up the current landscape for us in relapsing multiple sclerosis and where your commercial asset for Reonvi fits into that and how it kind of differs from the other anti, c d twenty antibodies on the market.
Sure. And, thanks for having us. Nice to see you. So, yeah, relapsing forms of MS is about I know. They say there's almost a million individuals in The US that have relapsing forms of MS, but treated are about three to four hundred thousand.
Of those, about eighty thousand ish will be seeking a new treatment every year. That includes people who are just naive to all treatments, but also folks who are switching from other treatments. It's It's a disease where folks will change treatments, every several years. And of the patients who start a new therapy, about fifty percent, maybe even a little bit more, will start on an anti c d twenty monoclonal antibody. So the the c d 20 class is has three drugs.
It's us and two others. One of them is given subcutaneously, and the other one is IV like ours. So the first point of differentiation for folks will be, you know, do you wanna self inject or not? That'll be one of the sort of the early questions that a clinician will ask. Once they've decided I'm skipping a few steps.
But once the clinician has decided that they wanna give someone a c d 21 of the first questions they'll ask them is would they prefer to self inject or not. If they do wanna self inject, today, there's only one option. Hopefully, we'll get to it at some point today, but we are developing a subcu option as well, which we will hopefully be able to compete in that market. But but if they do choose subcu and today, about 35%, maybe up to 40, the numbers are are not fully clear, will choose that sub q option. And then once you the remainder, which is the majority, 65%, will choose an IV.
And again, in the IV category, there's us in one competitor. And then differentiating between those, again, without getting into the deep science of the molecules and how they may differ, and there's very beautiful scientific paper that goes through the differentiators of all these molecules, but particularly between the two IV molecules, which was published last year. The authors Greenberg, I think, the lead author on that on that paper. I highly recommend it. I think it's available on our website.
Read that. That'll be a beautiful science discussion. But some of the simpler ones, you know, for for our IV product, the infusion is is one hour after the first starting dose. Their infusion is anywhere from a two hour infusion to a three and a half hour infusion. Our research says probably less than half the individuals on that competitor drug are getting the two hours, so most of them are still at three point five hours.
So there's a pretty big time savings potentially with the use of our compound. Like I said, there's lot of scientific differentiators. And then the other one, if if you can't decide if you're a clinician and you got two IV products and you just can't decide which one you think is better and you think they're about the same, well, one cost 20% to 25 less to the system. So if you have any social conscience and you wanna actually help the health care system, of course, you choose the one that's less.
Yep. With Priyomvi now in the market for almost three years, can you walk us through your 2025 revenue guidance and what metrics you're estimating to go into that, and currently your estimate for your market penetration in the
Yeah. Sure. So I think we started the year at about 05/20, 05/25. I can't remember exactly where we started the year for guidance. We've raised it now.
I think we're at $5.70 to $5.75 for full year '25. What goes into that, the the major inputs are gonna be new start basically, new start forms that we get to our hub so we're able to track that number. New start forms occur when someone takes a prescription and sends it into our hub. Not all prescriptions will make it to the hub, so you only send the prescription to the hub if you want one of our services. So if you want any help with patient support, some of our free drug programs, co pay support, any of those things, those will run through the hub.
So we have an accounting of those prescriptions. Any prescriptions that are not put through the hub, we don't have an accounting of. But it's definitely an indicator. It's not it's directionally gonna be correct. It's just not the whole story, but we use that as part of our of our build for our guidance.
And then persistence. Right? So as I mentioned, people change therapies quite often in MS. The CD twenties as a class and BRIONVY within that have a have a really nice persistence. I think a published paper for the ocrelizumab product showed about a five year median duration of therapy.
So, again, keeping patients on therapy for a long period of time will have a big impact on on the revenues that we project. So those are the two major impacts that we look at in terms of developing our guidance. And there was a second part of that question.
Estimated market penetration.
Yeah. So what we've said, we opened the year, we said we were approaching about a 25% market share of the IV market. So remember, we said that the sub q takes the first I won't say first, but of this equation, 35, 40%. So the 65% of that market. At the beginning of the year, we said we're approaching about 25%.
We said recently on our last quarterly call, we think we're approaching about one in three. So we're continuing to drive market share. It's a very competitive market, but we're doing a really nice job. The team out there working hard, and we've got some other things we're doing now on the patient side, which maybe we'll talk about as well. But, yeah, so we continue to push and grow that market share.
Right. You kind of talked about this a bit, but are the patients going on BrionV all newly diagnosed patients? Or, I guess, what percent of patients are switching either from a subcutaneous or OCREVUS?
Yeah. So we've never given the exact number of switches from other c d twenties, but we've said qualitatively that the the largest group of patients coming on to BREONVY are switches from other therapies. And I'll start by saying other therapies, not c d twenties. So the that's the largest cohort of the of the three I'm gonna describe. And then you've got newly diagnosed, and you have switches from c d 20.
The, the groups are are not all that different in terms of distribution across. I'd say the two biggest would be, the switch groups. The NIA would be the smaller part of it, but the the switch groups are the two larger components.
Got it. And how are patients doing on therapy, I guess, relative to your clinical trial experience? Are are you seeing, similar, I guess, efficacy that you saw in clinical trials?
So it is hard to say, because they're not in clinical trials. But, anecdotally, we hear our patients are doing well. The folks out in in Utah, the Rocky Mountain, MS Center did a real world presentation of their patients. They had over a 100 patients on Brion, and they did a real world study, which showed, you know, really nice activity. But probably more importantly than the activity, I think, is pretty unequivocal.
But in terms of tolerability and safety profile, that's kind of stuff that that is potentially more interesting. And, you know, they serve a much lower rate of infusion reactions, which I think is, particularly in the first dose. The thing about, Vreonvi is the the first dose, generally speaking, is that, you know, it it depletes B cells extremely rapidly. So you're gonna expect the most IRR in the in the first dose. In our pivotal clinical trial, by design, we did not give Tylenol with the first dose, which is one of the most common premeds with any IV antibody product.
We did it because we tested B cells the very next day, and we didn't wanna have any interaction with liver enzymes. So we were very deliberate about that, but we did show amazing b cell depletion twenty four hours after taking the drug. But we probably had a little bit higher IRRs than than needed to be. In the real world, everyone uses Tylenol, and those rates on that first dose have come down. What's really nice about the drug, and and you don't see this with the other IV product, is the rate of IRRs after the first dose, even with a one hour infusion versus a much longer infusion for the other product, the IRRs are are very low, in the five, six, 8% range.
You don't see that for the other comment. So, generally, Ramvy is viewed to be more tolerable from an infusion standpoint, because of that because it's it's not the first one. It's really the the others. But the first one, like I said, the real world experience, looks looks quite, like, quite good. Okay.
You mentioned some efforts to get more patients on therapy. So maybe if you could talk a bit more about what that looks like and where recent growth has been coming from.
Yeah. So we we we had a very deliberate and staged launch approach. We started out with a very experienced and continue to have a very experienced MS team field force that goes out and and talks to the clinicians, HCPs. And we had a very one of these tiered approaches where we went for the top one or two deciles, and then we grew from there. And that continues to work very well.
We deliberately did not do too much on the direct to patient side. We felt that it was important to make sure the clinicians were educated and receptive before a patient walked in and started asking about the drug. We're now two point five years into launch. Many clinicians have asked us to do directed to patients so that when they're talking to the patient, that they're they are aware of the compound. So that has been a big push that we just launched.
I think two or three months ago, we maybe even last, we launched our first, I call it, TV commercial. TV, I'm the last guy who watches TV, but we do it on, you know, all the services and, you know, things that you probably watch. Yeah. So, yes, that's been a big effort, and we think that's so far working out well. And we have a lot more to go. We really just we just started that.
Alright. Great. Can you discuss your ex US commercialization plans? I know you have a partnership with Nurax Farm. And how is that kind of expected to grow in coming years?
Yeah. So, you know, they're a private company, so we can't say too much about, you know, what their projections are. I mean, we don't say much more about our projections except till the end of this year, so it'd be hard for me to say too much about theirs. But, you know, I I think, you know, they're doing a very nice job. They built a a really good team.
They hired a really skilled group of MS professionals to to work on on the product. It's a it is their key products that they're committed to, which is which is exactly what we were looking for, a team that would do that. Yes. I think it's going well. You know, we've we've always said, you I think for modeling purposes, for people who are looking at I mean, The US sales are always gonna be the vast majority of of the revenues.
They'll be incremental. We have a very nice set of milestones. We do have a very nice royalty. But, you know, you'd have to you have you have to say they're they're always gonna be at least sort of almost two years behind us in the launch phase. Right?
Maybe a year and a half, so whatever year and a half plus in the launch phase, and then you assume that, you know, the ex US market is 25% of The US market. So you keep dividing that number. It's just not gonna be material to our overall revenues, and we've we've tried to try to guide for that as well. But but it'll always be nice. I I think it'll be very nice, and some of the numbers and the milestones could grow.
So it's it's good. I think it's a very good deal for us, very good deal for them.
Okay. Could you discuss your development? You mentioned the subcutaneous formulation, and you also have, a shorter dosing regimen that you're looking at, and how the regular regulatory pathway for those, approvals could look like.
Sure. So I'll I'll I'll do it in sequentially, but not in in importance. Sub q is obviously more important. But the the combined first dose first doses, so that study is up and running. We we announced that a little bit ago, maybe a month or two.
And we're hopeful that that will yield us data next year in a in a label update in in '27. So that that the concept is instead of having to come back on days one and day 15, the individual only come in on day one. They'll get a basically, the the dose that you would get on day one and fifteen together in the same four hour infusion they get on day one today, and then they wouldn't have to come back for six months. So that'll simplify both for the patient. But, also, what we hear is the scheduling of the double two infusions at once makes it more challenging to get patients started because you have to have the other one scheduled at the same time.
So that's gonna be a nice convenience factor, I think, both for patients and for facilities in scheduling and timing. And then, clearly, the more important one is our subcu. We announced this morning that we had started the enrollment into the subcu pivotal trial that we anticipate should complete enrollment probably by the middle of next year, which puts us on a path for an approval. This this would be a a a new BLA, put us on approval in '28.
Okay. Can you just assess what the phase three design is like? And do do you need to show, I guess, similar efficacy to what you showed at the IV formulation?
Yeah. So so the primary endpoint is gonna be a PK based. So it's a basically, it's a noninferiority to area under the curve, I believe, over twenty four weeks, so the first six month period. So that is the primary. Of course, we will track, you know, all classic efficacy endpoints that we use in these studies, but the primary is the is often the the PK, and that's customary for for all, you know, IV to PK to sub q switches.
Mhmm.
We're looking at just as another part of design. We are looking at two intervals. We're looking at dosing every other month and quarterly. So that's built in. So there's actually three arms, the IV arm and then the two sub q arms. And, again, AUC, noninferiority.
Got it. And I guess how do you expect a subcutaneous option to expand the market opportunity for Breonvy? Obviously, we talked about that Kesimpta currently probably has 30 to 40% of the market. So I guess how much of that do you think you could potentially take?
Well, hopefully, all of it. Don't tell the people in Novartis that people are upset to hear that. Obviously, we're going to try our best to get as large a portion, excuse me, of that market as we can. We think the Breonvi product brand and name are quite strong in the MS space already, and we'll continue to grow between now and when we launch that product, hopefully, in 2028. So we think we're in a good position to capture market share.
We think we could have a convenience advantage. Currently, ofatumumab is dosed as a monthly product. We know they're working on it in every other month product, but, potentially, we could have a a little bit of a community advantage there as well. So I think we're we're gonna be a highly competitive product, nice profile. Yeah.
I think we'll we'll do I think we'll do quite well.
Mhmm. Maybe in the last few minutes, we could talk about your other indications and earlier stage assets. So I know you also have a trial in myasthenia gravis. What what's the role of c d twenty in MG and, where are you with development with that program?
Yeah. So it's it's interesting. We are we are very early in our well, I wouldn't say we're very early. We're we haven't made a decision yet if we're actually moving forward in MG. I think we've we've talked about it as we are we are treating some patients.
We're just, you know, trying to dip our toe into another area that could be interesting for for Breomni. MG is is potentially this there's been a recent positive pivotal trial for a c d nineteen product that I'm sure you're aware of, and we're we're sort of waiting to see how that evolves, or we're also trying to think of ways in which we could be a little more creative in coming into the marketplace. So I think we're we're weighing two two potential approaches. One is sort of very standard approach. It would be competing directly against c d nineteen, and the other would be maybe setting up for a different type of profile for the product in that indication.
Of course, we would be the only subcu CD19CD20 product going into that indication right now. So that could have some competitive advantages. But again, I think I don't want to get too out over my skis on MG. We've talked about it as something we have an I'll say we have an exploratory committee, and we're we're looking into it, but no no commitments yet. We'll keep you posted if we move forward for sure.
Okay. Great. And then your two earlier stage assets, t g 1701 and your c 19 CAR T azur cell, What are the current development plans for those programs?
Yeah. For the moment, we've been, we've been on hold on the the BTK waiting to see how that all evolves. We've seen some of it evolve. I think we're still on the sidelines for the moment. And then with the AzerCell, our CD19 allogeneic CAR T, we're very excited about the product.
I mean the concept, the area, we really do believe that there is a role for CAR T in autoimmune diseases. We clearly believe that, you know, Allo is a if Allo works, it's a better mousetrap, and then there's gonna be improvements that will continue to have to be made to to make these products, whether through clinical development or otherwise, into the product improvements. But there is a big opportunity here. Hopefully, we have the right molecule to do it, but I do think it's a big opportunity. Right now, we're we're in progressive MS.
We treated our first patient. There was a big media around it. We didn't put out an APR, but the University of Nebraska had done some interviews on on the local press and kinda spread around for a while. It was the it was the first ally to be used in a in a progressive MS patient. Anecdotally, the woman said she's never felt better in her entire life, and she was you should just watch the watch the the the video.
It's on I'm sure you can find it pretty easily. So so that created quite a buzz, so we've got a lot of interest in that product now through that. We've got a number of sites open. We should be picking up enrollment shortly, and we're also expanding the protocol from primary progressive MS only. We'll be including both relapsing MS, but also things like NMO, MG, and a few other indications.
So that's that's looking to expand. Hopefully, we're gonna see a lot more data see a lot more patients. You might not see the data, but we're hoping to see a lot of patients, in 2026 on that drug.
Right. And then maybe to close out, if you could just give us, a summary of upcoming catalyst milestones for the next year or so.
Yeah. I mean, I think a lot of it is gonna be revenue based. I I would imagine that, most folks are are are not, have not well modeled, the Burmbee opportunity. So I think over time, we're gonna continue to upside surprise as we continue to have to up update our our our revenue forecast. I'm not talking about this year, but I think I don't think people appreciate what next year will look like.
We haven't said anything yet, but that will be said early next year. And then in terms of Catalyst, we'll have the ENHANCE data in '26. So ENHANCE is the combination of the first two doses. Probably in late twenty six or '27, we'll have the subcu data. So I think we've got some some well placed, data coming up, through that process.
And then, yeah, the wild part is across across '26. Is there data that actually comes out of the the azure cell program or is that '27 data? So we're not sure. Depends how enrollment goes. And then, you know, whatever we decide, with respect to MG, we'll see how that works out.
Got it. Awesome. Well, thank you very much, Michael. Thanks everyone for listening in. We'll conclude now.
Thank you.