Conference Transcript - TGTX 2026-06-03

Roger Song, Analyst — Jefferies

Hello, everyone. Welcome to Jeffrey's 2026 Global Healthcare Conference. My name is Roger Song, senior in this cover. Smica Biotech, it's my great pleasure to have the fireside chat with our next company, TG Therapeutics. We have the CEO, Mike Weiss.

Mike Weiss, CEO

Thanks, Roger. Great to see you.

Roger Song, Analyst — Jefferies

Awesome. All right, so we have exciting news. So you just appreciate you use the platform or the timing to announce the phase one sub-Q BrownV data early this morning. We're definitely going to talk detail about that. maybe take that back you know if you use a a minute or two to you know just give us some high level overview of a tg what what tg at this at this moment and what's the you know coming

Mike Weiss, CEO

future yeah sure thanks and thanks again for having us uh yeah tg we've always tried to keep the story relatively simple so obviously we have briam v on the market i think we're three and a half years into the launch. Our projections for this year are year-end. U.S. only is $885 to $900 million, so sales are going well. We're just in the early phases, really, of tapping into this market. I think we've stated our goal a while back that we want to be the number one CD20 at dynamic market share. We just surpassed that for one subsector of the market, so we're super excited about that for the private practice with Infusion Center, So we're now number one in that sector, and we're going to just keep taking market share everywhere we can, every way we can, until we get to the number one spot, starting with IV, right? So we want to be the number one IV. That's step one. And as you alluded to, and we'll talk more about it, we had some exciting news this morning with regard to our sub-Q program, which I won't get into detail for the moment. But, yeah, so I think, you know, the overall is continue commercial execution. We have a really great R&D platform, so rapid development of our enhanced new dosing for starting on BreonV. So when you start on Breon V or any CD20 for MS, for IV, it's a day one, day 15 dosing, followed by every six months for the IV programs. We're now consolidating day one and day 15. We had a positive phase three that was read out last week, I think, probably last week. So that will hopefully even simplify further and solidify further our competitive advantage in the marketplace. Sub-Q execution ongoing. Phase three is fully enrolled, waiting for the phase three data. We put out the phase one today. Phase three data will be year-end. Hoping to launch the simplified dosing for BRYOMV sometime in 27 and the sub-Q in 28. And then we've also said we've got some new indications that we're looking at potentially for BRYOMV. So we do see it as a pretty straightforward, you know, product in a platform, platform in a product, platform in a product, yeah. It's good to reverse. My dyslexia sometimes pops in. But, yeah, so we're going to look to expand the potential use into other indications for Brionvy. And then we have, I'd say, a relatively small pipeline today beyond that, which is our Azercel anti-CD19 product, which is working its way through phase one and we have an active BD program and we're looking at some pretty interesting opportunities and we're continuing to do that. I think that's probably us. And we buy back shares every chance we get because we obviously believe that the shares are undervalued at these levels. Despite today's small increase, we still see the stock is grossly undervalued.

Roger Song, Analyst — Jefferies

Yep. Awesome. All right, Michael, I know you guys since my day went on Wall Street and then it's been 10 years so it's a it's a quite a quite a journey i think simple story is winning here so i think honestly when you say you want to focus on cd20 ms i don't believe anyone really think you can take a 800 900 billion dollar revenue let alone number one dynamic share against the big farmer right we have a big dog over there and the big boys to doing this space and you're taking the share and then now it's leading and i i have full confidence you will get you know To where you want to be and then the particularly with today's sub queue formulation. Maybe you can even expand the opportunity there Okay Exciting maybe we spend a decent amount of time to talk about the data today because it is a press release We took a look in detail. I think it's a probably people in the appreciate how meaningful that data say is Maybe you give us how you interpret that data and then I can ask some more pointed question see how we align on that

Mike Weiss, CEO

Yeah, I mean, look, first off, you know, let me just say the team did an amazing job of catching up in our ability to present that data and create a sub-queue, right? So the creation of the sub-queue itself has its own set of challenges. The team, our CMC team, did an amazing job of creating this proprietary formulation. We evaluated all the technologies out there, but we really created what was, you know, I think the best possible outcome of a really highly concentrated, low-volume product. So, you know, grateful for the team for being able to do that. And that was picked up by our clinical and regulatory teams who have done an amazing job of rapidly moving forward with that program. So, you know, kudos to the team to put us in a position to, you know, you mentioned some other things. The companies, I'm sure, today, they're not feeling so happy in seeing that data come across and what they're going to be coming up against in the short term. And that probably leads to the question, which is, you know, what does it mean? So right now, the CD20 market is divided basically into two really distinct segments. And it's kind of because there's a threshold question. So the segments are HCP administered. So you go to your doctor, they give you the CD20, or you do it to yourself at home, or honestly, you could do it anywhere. But it's an auto-injector kind of approach. The market breaks out about 60%, 65% IV, 35%, 40% to sub-Q. And like I said, the distinct market is because once the clinician decides that they want to treat a patient with CD20, The first question they ask is, do you want to self-inject or do you want us to do it for you? And that really creates this distinction between the two marks. So anyone who self-identifies as someone who'd like to self-inject, we don't actually today compete for that market. We only have an IV available. We do not compete for that marketplace. So while it's 35%, 40% of the patients that are choosing that option today, we think it's possible it grows over time. So we'll see how that shakes out. But also, if you look at the pricing dynamics in that marketplace, if you put the two pieces together, the 35%, 40% plus pricing dynamics that are different, we think it's probably at least a doubling of the addressable market for us. So if you thought IV Burembi was going to be a multibillion-dollar product, which we certainly do, and we've said that multiple times. I don't know that anyone listens to us. But we've said that multiple times, and we truly believe it. Well, you could basically just say that we've now doubled or more than doubled what we think our total market potential for the product is.

Roger Song, Analyst — Jefferies

Yeah. Maybe just zoom in for today's data, right? So it is a phase one, mostly bioavailability data. but also you did some modeling to predict the phase three data going to be later this year, which is the bioequivalent or non-inferiority data. So how you link those two, the 60% bioavailability to the modeling and then the phase three, how much more, you know, the POS is increased by how much, and that's probably the people figuring out right now. Why the stock is up 10% versus we're predicting 10% to 30%. Why not 30% of it?

Mike Weiss, CEO

Why not 100%?

Roger Song, Analyst — Jefferies

No, not 100%, yes.

Mike Weiss, CEO

I mean, I would think 100 percent, but, anyway, so, yeah, the data is, again, it's a pretty straightforward kind of study. One, you know, your first time, it's the first time we ever treated anyone with a sub-Q version of ublituximab, right, which is the active ingredient embryometry. So this is ublituximab in a different formulation than we currently use for the IV form. and so you know step one is you inject it into someone under their skin and you want to make sure that it's safe enough to do that right so that's step one once you actually have a formulation that's highly concentrated and can be pushed through a through a needle which is again not a not a trivial task in and of itself but the phase one you know step one is just make sure you can safely do it then as you continue to dose patients you're creating a database of basically drug exposure right and yes that gets modeled into I don't know why but I paid a fortune for them to tell me the exact number that I calculated based on the back of a piece of paper but I'm happy they did it the professional way versus the Mike Weiss way which is you know once you know the bioavailability and you multiply that times the amount of drug you give all you have to do is divide that by the amount of drug you're trying to match up to which is what we did in you know so the model comes out with 1.21 Mike Weiss simple math was 1.2 so I think we I think we're pretty much and and since the model and prediction in mind it is it's still just you know there's still confidence in around around all these pieces but yeah it's it's a pretty simple process right you know you once you get all the the the basically drug exposure which is basically represented by area under the curve of the of this you know drug distribution curve the uh they again they calculate it they do this fancy modeling uh but again the simple mathematics for those who are interested simple math is once you identify from that information what the bioavailability is you can pick your dose by just saying, okay, if I need 600 milligrams, which is our case, we give 150 milligrams on day one, 450 milligrams on day 15. So that's 600 milligrams in the first four months. Now, ours was about 60% bioavailability, but if you thought your bioavailability was 50%, you would give 1,200, right? That would be 1,200 times 50% would equal 600. We built ourselves a cushion. Even though it was our 60%, we still gave 1,200 with the cushion. That came out to the 1.2. Again, the bogey here is you don't want to come below 0.8, right? That ratio of what you get in to what you're targeting, you don't want to go below 0.8 because then you'd be non-inferior, and you cannot at that point say that the drugs are equally as efficacious, right? So that's really the most important part is you don't want to go below 0.8. On the upside, you ideally will stay close to 1.25, which is the top end. But with antibodies, you know, almost all of them always go over the top. Some a little bit, some almost double, like Optivo, went almost double when they went to the sub-Q. But again, the lower bound is really the one that is most troubling.

Roger Song, Analyst — Jefferies

Got it. All right, so let's just ask a more professional way to do this math. I think the two components, in terms of the bioavailability, I think the confidence interval is pretty tight, right? So the lower bound is 0.55, and the point estimate is 60%. You know, how confident you are on this is statistics, right? So 80-plus patients, and then how you think about this patient population compared to your phase three, this bioavailability going to translate. But using that data, statistically, 95% chance they're going to above 55%.

Mike Weiss, CEO

Yeah, and in the phase three, the confidence intervals will be even tighter, right?

Roger Song, Analyst — Jefferies

If the point has to be the same, then, yeah.

Mike Weiss, CEO

Yeah, if the point has to be the same. But, yes, if you just look at the 1.2 model, 1.21, with the lower bound of 1.15, Again, that's basically saying that, you know, it's possible that the true point estimate is 1.15, right? There's a small chance it's within that range that that is true. But again, we'd have to go down to, you'd have to have bioavailability slide close to 40 percent, which is highly, highly, I mean, on the, on that normal distribution curve, to get down to 40% bioavailability, my guess is you're in the 99-plus spot. So it's a tail event. And then, of course, we have the every other month just in case there's some sort of outrageous tail event. But, again, I think we're not even thinking about it nor worried about it at this point. But, yeah, the bioavailability would have to drop off dramatically and change, and, you know, that would be highly, highly unlikely. So, yeah, we've got a lot of cushion on the downside, for sure.

Roger Song, Analyst — Jefferies

So, I don't want to talk too much about the storm move kind of movement because we know it's kind of a voting machine, so it's not necessarily the fundamental. But on the other side is that the reason it's not much higher than the current appreciation, maybe just people not picking up this, how likely you're going to miss the area and the curve in the phase three because based on my conversation, people are really looking for that data into the phase three. Now it's just a matter of how you're gonna read all data but based on this by availability data, if it's within this normal distribution, it's no way you're gonna miss the area in the curve. So I think people should understand that.

Mike Weiss, CEO

Yeah, look, I've always seen there's people who get the information quickly, there's other people who process a little more slowly and there's others that take even longer to figure it out. I'm not too worried about it but yeah I mean in terms of you know the value that was created today versus the value that's reflected in the stock change it's not there yet but people are a little slow sometimes

Roger Song, Analyst — Jefferies

it's a pity time so I

Mike Weiss, CEO

they'll figure it out

Roger Song, Analyst — Jefferies

okay just make sure we're not missing anything and then the other thing is simple math is basically by variable times a dose you're getting one of the we build some PK model as well you know just you know slightly less professional way but it's a little bit more kind of back the envelope type of the modeling the key thing is accumulation right so when you give the drug and a sub q and then how this different compartment gonna process the drug and then that feeding to the area in the curve but this one seems pretty straightforward like you're just using the bioavailability and then no accumulation no acceleration of the clearance so that seems that how you yeah it's not I mean those are things you

Mike Weiss, CEO

think about more when you think about small molecules again we're dosing I mean the first two doses do occur within 15 days of each other but that's the same for IV and then you're not giving another dose for three months in the quarterly there's no real accumulation in the the half-life is 21 days you're going out what is that four or five half-lives then you're adding in the next dose. So in essence, I mean, look, when you give the dose IV, you're going to get one curve that looks like this. When you give the drug sub-Q, you're going to get one curve that looks like this. You're going to get a second curve that looks like this. And you're just measuring the area of each of those curves. And it's not complicated. I mean, the modeling folks have made it super complicated, but I can assure you the simple math uncomplicates it dramatically and comes out with basically the same answer.

Roger Song, Analyst — Jefferies

Okay. Got it. Alrighty. And then in terms of the phase three, so now you mentioned every three months, but I just want to be clear. Your every two months dose is way higher than every three months, which means even we say have a tiny, tiny chance that you may not hit every three months, but every two months is even bigger buffer. Yeah. They kind of, you know, look, they,

Mike Weiss, CEO

If the anticipated bioavailability is realized, which we expect, they're going to land somewhere where they are today, right? If in some weird world the bioavailability is dramatically lower, they both shift together, right? They both shift together. So, yeah, that is the worst-case scenario now. it it used to be that you know the every three months was maybe an option and and the every other month was sort of the down the fairway yeah I think right now down the fairway is is the every three months and the very low probability is we'd have to use the every other month yeah that's right but it would be almost you know it'd be very it'd be almost impossible to find a scenario where one of the two doesn't work but again I think the probability of the every three months not working is already a tail event.

Roger Song, Analyst — Jefferies

Okay, all right. Basically, it's Bryson DeChambeau or Jordan Spieth's driver. Both of them are good, right, on the fairway, right? Okay, very good. So in terms of the, you know, every two, every three, commercially, you test. I think both of them are very viable. Do you see meaningful difference if you have every three months, I still think it will be a lot bigger uptake, dramatically different from the current drug every month, compared to every two months.

Mike Weiss, CEO

I mean, I think every three months we'll probably put them out of business. No, I'm just kidding. Maybe, maybe. As much as I'd like to do that. Look, more convenient is always going to be, or less frequent. I don't know if I'm allowed to say more convenient. Less frequent is always going to be better. You know, in our market research to date is definitely a difference, potentially dramatic, but we're going to do some more market research and really try to get a full sense. But, yeah, I mean, we're pretty happy with every three months. We think it's a, this is not my quote, but this is a quote from a single patient, so it's an anecdote, of course, quote from a single patient who heard that we might be doing ours every three months, and they're on the every one month, and the word was, oh, that's a game changer. Okay, so that's a single anecdote, but yeah, I think it could be meaningful. Yeah, good.

Roger Song, Analyst — Jefferies

And then, by the way, it's a high concentration, also low volume, which means you can do auto injection you were doing the bridging study but you will launch with

Mike Weiss, CEO

the auto injection yeah the full plan is to launch with the auto injector not with a with a needle injection got it there'll be a needle in the auto

Roger Song, Analyst — Jefferies

injector but not a not it to be clear that's right and then the T in terms of the economics we know it's a kind of a different world like a part D versus part B but you mentioned earlier that decision already made a very upfront by Mostly by patient or, you know, they just decide, okay, I want to self-inject versus I kind of go to the office every seat. I see you every month, every six months anyway, right? I kind of wanted to do that. How much economic or economic to physician going to play into this decision versus the patient decision preference?

Mike Weiss, CEO

Yeah, it really shouldn't have any impact on clinicians and their economics and how they think about things. Again, they're already, you'd be surprised, even in the highest infusing centers around the country, they still use a lot of sub-Q because if it's better for the patient, they give the patient the sub-Q. So it really still is that threshold question in nearly every center. I mean, they're always going to ask that question. So what's happening today, you know, it shouldn't change all that much. We would not expect folks to be choosing this or switching from, particularly not switching. They've already self-selected to be IV. It's not like we think that they're going to be switching to sub-Q. It's the new patient population coming in or people coming off of another sub-Q product that want the convenience of Breonvy or just want to be on the opportunity to be on Breonvy. Again, we haven't even talked about the differentiation of the molecules, but that will come as well. That's something we haven't done yet.

Roger Song, Analyst — Jefferies

Is that a population, they are not happy about either the current every six months IV or sub-Q or every month sub-Q? Now with this potential, every three months sub-Q, those populations say, those patients will say, yeah, I wanted this as the CD20 option. Do you think that population, how small, how big that population could be? I'm thinking about expanding the current market versus taking share from others.

Mike Weiss, CEO

Expanding the overall CD20 market for people who, it's hard to say. it's hard to say I mean as as more as as more products are available the market will naturally expand community community neurologists that don't have infusion capabilities is it is a pretty large area for expansion so there is it is expanding to those folks they are using the sub Q they don't they don't use the infusions, I think there is room to grow into that population for sure. How big that is, I'm not sure, but, you know, the market's quite large as it is, and I do believe it will grow into some of those centers as well.

Roger Song, Analyst — Jefferies

Okay, awesome. All right, we spend most of the time on the subcube because that's fresh off the press, the data, but, you know, I think you mentioned earlier that's also news to us is that you're already taking the number one dynamic share in the private sector, so that's very encouraging. and then what will be the key drivers you keep pushing the IV? I did see it quite a few times for the TV ads. Oh, some of the different platforms. So DTC and then some of the campaigns. So what's the secret sauce so you can keep the momentum and get to the number one dynamic in IV space?

Mike Weiss, CEO

Yeah, I mean, for the moment, it's continuing to do what we're doing, which is we have an unbelievable, I'd call it ground game, right? So in football terminology, we've got a great ground game. Our sales and affiliated infrastructure on the ground, in the offices, continues to grow at a moderate or modest but really measured pace. So we continue to build out and continue to get to places with more frequency and get to places that we haven't been able to get to. And then the air game is what you're referring to, DTC. You know, we've been – we continue to experiment with, you know, with different content, different mediums of where we're going to, and, you know, we continue to narrow in on what's working best for us, and we continue to double down on those things. So I think the combination of continuing to do our ground game the way we've been doing it with, you know, I think almost at this point undeniably the best field force in the business, layering on top of that the DTC campaign, doing it right. We brought in a great new team that are really, you know, just doing tremendous stuff in terms of revamping all of our content and our focus. And then, you know, the last thing is, you know, and people have heard me say this many times, you know, it's also building that social network effect, right? So we have now, I think, upwards in over 25,000 individuals globally that are on ReUmvi. You know, it's still the smallest of the three in terms of that social network, but critical mass is important. It's not just the largest, but you need a critical mass. I think we're getting there, and the more patients that go on Breonvy, future patients, more patients will go on Breonvy. So put the three pieces together. We just keep grinding away. And then, you know, excitingly next year, we get to launch, hopefully, you know, with the positive phase three data for Enhanced. I think the new consolidated dosing is going to be probably more impactful than people are giving credit to. We've had amazing interactions with clinicians. We were at CMSC talking about the data this past weekend. I'm personally surprised at the level of enthusiasm and what people are talking about, how much easier it's going to make things for them and how much more attractive it's going to be for patients. So I think that's probably, we've probably been under selling that, but, you know, that in a launch scenario with new content and invigoration of, you know, the whole program, I'm excited for that. I think it's going to be a really big event for the company, actually.

Roger Song, Analyst — Jefferies

Absolutely. And then, by the way, once you get a sub-Q approval, you will be the only CD20 MS company having both true IV six months and then true sub-Q at-home self-injection.

Mike Weiss, CEO

So that's it. You couldn't say it better than Adam.

Roger Song, Analyst — Jefferies

Okay. You mentioned him a couple times. He's the best force in the market, so that's good.

Mike Weiss, CEO

Yeah, thanks for bringing that up. I do appreciate it. So, yeah, I mean, we think it puts us in a really nice competitive position. you know i think in the in the medium term we're going to be the only company that's really in the ivy marketplace i think one of our competitors that's there is seemingly based on their public statements trying to move as far away from that as as they can and one has never been there so i think the advantage that we have again of having both we've got We've got a positioning that can put clinicians to say, do you want IV or do you want sub-Q? They don't have to talk about anything else. They can just offer Breon V. And we know a number of centers have already said that that is their plan. And then there will be Adam's job and the team's job to get every center to make that their plan, to simplify the process for the patients so they don't have to overthink it. Do you want sub-Q? Do you want IV? We have one molecule, and we can get you on it.

Roger Song, Analyst — Jefferies

All right. no pressure items every center just choosing uh brian v alone okay last minute um maybe anything else you want to you have a kind of the earlier pipeline it's actually knowing the stock and then you're not spending too much but you maybe that's all the upside and the optionality

Mike Weiss, CEO

uh yeah i mean you know so azer is uh is coming along it was a little slow to start but it's starting to really accelerate now and as we hopefully before year end get to a dose that is sufficient and we can you know open up enrollment the the demand far exceeds our slots right now so again we've talked about this publicly I mean that is usually a pretty good sign that there's an unmet medical need in the marketplace and that is certainly in progressive MS but we also opened up now i think we have mg open nmo open cidp open so we do think that there's i mean real opportunities in in all of those in all those places and they're all uh really commercially adjacent to where we're sitting today so it makes it a pretty straightforward move into those spaces and the last thing i'll say as i'm really thinking about adjacent spaces i mean sub q the lift for sub-q i mean this is not a situation where we have a new new indication or a new drug and a new new indication i mean this is 90 overlapping sales effort 100 overlapping and basically marketing effort i mean yeah it's different but you know the same pieces you don't have to we're not hiring new teams uh we will probably hire some more access people because as you mentioned part d versus Part B, but I mean this is a highly leverageable opportunity with a very limited associated additional cost. Yeah, simple story, gonna win. Awesome.

Roger Song, Analyst — Jefferies

All right, thank you Mike, thank you everyone. Thank you Roger, appreciate it. Thanks everybody.