Hello, everyone. Welcome to the Jefferies Global Healthcare Conference 2026. My name is Roger Song, senior analyst cover small/mid-cap biotech. It's my great pleasure to have the fireside chat with our next company, TG Therapeutics. We have the CEO, Mike Weiss.
Thanks, Roger. Great to see you.
Awesome. All right, we have exciting news. You use the platform or the timing to announce the phase I SUB-Q BRIUMVI data early this morning. We're definitely going to talk detail about that. Maybe we'll take a step back. If you use a minute or two to just give us some high-level overview of TG. What TG at this moment and what's the coming future?
Yeah, sure. Thanks. Thanks again for having us. Yeah, TG, we've always tried to keep the story relatively simple. Obviously, we have BRIUMVI 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 million-$900 million. 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 in dynamic market share. We just surpassed that for one sub-sector of the market, so we're super excited about that for the private practice with infusion centers.
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, till we get to the number one spot, starting with IV, right? We want to be the number one IV. 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. I think the overall is continue commercial execution. We have a really great R&D platform, so rapid development of our ENHANCE new dosing for starting on BRIUMVI. When you start on BRIUMVI 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 III that was read out last week, I think. Probably last week.
That will hopefully even simplify further and solidify further our competitive advantage in the marketplace. SUB-Q execution ongoing. phase III is fully enrolled, waiting for the phase III data. We put out the phase I today. phase III data will be year-end. Hoping to launch the simplified dosing for BRIUMVI sometime in 2027 and the SUB-Q in 2028. Then we've also said we've got some new indications that we're looking at potentially for BRIUMVI. We do see it as a pretty straightforward product in a platform in a product. Yeah. Always get that reversed. My dyslexia sometimes pops in. Yeah. We're going to look to expand the potential use into other indications for BRIUMVI.
We have, I'd say, a relatively small pipeline today beyond that, which is our Azer-cel anti-CD19 product, which is working its way through phase I. 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.
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 as grossly undervalued.
Yep. Awesome. All right, Mike, I know you since my day one on Wall Street, it's been 10 years, it's quite a journey. I think simple story is winning here. I think honestly, when you say you want to focus on CD20 MS, I don't believe anyone really think you can take an $800 billion- $900 billion revenue, let alone number one dynamic share against the big pharma, right? We have a big dog over there and the big boys to do in this space, you are taking the share, now it's leading. I have full confidence you will get to where you want to be. Particularly with today's SUB-Q formulation, maybe you can even expand the opportunity there. Okay. Exciting. Maybe we spend a decent amount of time and talk about the data today because it is a press release.
We took a look in detail. I think it's probably people underappreciate how meaningful that data set is. Maybe you give us how you interpret that data, and then I can ask you some more pointed questions, see how we align on that.
I mean, look, first off, let me just say the team did an amazing job of catching up in our ability to present that data and create a SUB-Q, right? The creation of the SUB-Q itself has its own set of challenges. Our CMC team did an amazing job of creating this proprietary formulation. We evaluated all the technologies out there, we really created what was, I think, the best possible outcome of a really highly concentrated, low volume product. Grateful for the team for being able to do that. That was picked up by our clinical and regulatory teams, who've done an amazing job of rapidly moving forward with that program. Kudos to the team to put us in a position. You mentioned some other 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. That probably leads to the question, which is, what does it mean? Right now, the CD20 market is divided basically into two really distinct segments.
It's kind of because there's a threshold question. 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. It's an auto-injector kind of approach. The market breaks out about 60%-65% IV, 35%-40% to SUB-Q.
Yep.
Like I said, the distinct markets, 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?
That really creates this distinction between the two markets. Anyone who self-identifies as someone who'd like to self-inject, we don't actually today compete for that market.
Yep.
Right? We only have an IV available. We do not compete for that marketplace. While it's 35%-40% of the patients that are choosing that option today, we think it's possible it grows over time. We'll see how that shakes out. 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. If you thought IV BRIUMVI was going to be a multi-billion-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.
Mm-hmm. Yeah. Good. Maybe just zooming for today's data, right? It is a phase I, mostly bioavailability data, but also you did some modeling to predict the phase III data, going to be later this year, which is the bioequivalent or non-inferiority data. How you link those two, the 60% bioavailability to the modeling and then the phase III, how much more the POS is increased by how much, and then that's probably the people figuring out right now. Why the stock is up 10-ish% versus we're predicting 10%-30%. Why not 30% today?
Why not 100%?
Why not 100%, yes?
I would think 100%. Yeah. Anyway, yeah, the data is, again, it's a pretty straightforward kind of study. It's the first time we ever treated anyone with a SUB-Q version of ublituximab, right? Which is the active ingredient in BRIUMVI. This is ublituximab in a different formulation than we currently use for the IV form. 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? That's step one. Once you actually have a formulation that's highly concentrated and can be pushed through a needle, which is, again, not a.
Trivial
trivial task in and of itself. The phase I, step one is just make sure you can safely do it. As you continue to dose patients, you're creating a database of basically drug exposure, right?
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 Michael Weiss way, which is 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. The model comes out with 1.21.
Michael Weiss simple math was 1.2. I think we're pretty much. Since the model and prediction in mind, there's still confidence around all these pieces. Yeah, it's a pretty simple process, right? Once you get all the basically drug exposure, which is basically represented by area under the curve of this drug distribution curve. Again, they calculate it, they do this fancy modeling. 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 mg," which is our case, we give 150 mg on day one, 450 mg on day 15. That's 600 mgs in the first four months. Ours was about 60% bioavailability, but if you thought your bioavailability was 50%, you would give 1,200 mg. Right?
That would be 1,200mg times 50% would equal 600 mg. We built ourselves a cushion. Even though it was our 60%, we still gave 1,200 mg with the cushion. That came out to the 1.2. 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. 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. With antibodies, almost all of them always go over the top. Some a little bit, some almost double, like Opdivo went almost double when they went to the SUB-Q.
Again, the lower bound is really the one that is most troubling.
Mm-hmm. Got it. All right. Let's just ask the more professional way to do this math. I think there are two components in terms of the bioavailability. I think the confidence interval is pretty tight, right? The lower bound is at 0.55, and the point estimate is 60%. How confident you are on it, this is statistics, right? 80+ patients. How you think about this patient population compared to your phase III, this bioavailability going to translate. Using that data statistically, 95% chance they're going to above 20%- 55%.
Yeah. In the phase III, the confidence intervals will be even tighter, right?
Yeah, that's right. If the point estimate the same and then, yeah.
Yeah.
Yeah.
The point estimate the same. 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 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. Again, you'd have to have bioavailability slide close to 40%.
Unlikely. Yeah, that's it.
Is highly unlikely. On that normal distribution curve, to get down to 40% bioavailability, my guess is you're in the 99+ spot. It's a tail event. Of course, we have the every other month, just in case there's some sort of outrageous tail event. Again, I think we're not even thinking about it nor worried about it at this point. Yeah, the bioavailability would have to drop off dramatically and change and that would be highly unlikely. Yeah, we've got a lot of cushion on the downside for sure.
Yeah. I know I don't want to talk too much about the stock move kind of movement because we know it's kind of a voting machine, so it's not necessarily the fundamental. On the other side is 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 under the curve now if you are in the phase III. Based on my conversation, people are really looking for that data into the phase III. It's just a matter of how you going to read our data. Based on this bioavailability data, if it's within this normal distribution, it's no way you're going to miss the area under the curve. I think people should understand that.
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.
Yeah.
Yeah, in terms of 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.
Yeah. It's BD time, so I won't.
They'll figure it out.
Yeah, sure.
They'll figure it out.
Yeah. Okay, just to make sure we're not missing anything. The other thing is simple math is basically bioavailability times the dose you're giving. We built some PK model as well, just slightly less professional way, but it's a little bit more back of the envelope type of the modeling. The key thing is accumulation, right? When you give the drug in a SUB-Q, and then how this different compartment going to process the drug, and then that feed into the area under the curve. This one seems pretty straightforward, like just using the bioavailability, and then no accumulation, no acceleration of the clearance. That seems that how you.
Yeah. Those are things you think about more when you think about small molecules.
Again, we're dosing. The first two doses do occur within 15 days of each other, that's the same for IV. You're not giving another dose for three months in the quarterly. There's no real accumulation. The half-life is 21 days. You're going out, what is that? Four or five half-lives, you're adding in the next dose. In essence, 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.
Yeah, the area under the curve.
the area under each of those curves.
Yeah.
It's not complicated. The modeling folks have made it super complicated, but I could assure you the simple math uncomplicates it dramatically.
Okay.
Comes out with basically the same answer.
Okay. Got it. All right. In terms of the phase III, 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 chance that you may not hit every three months, but every two months is even bigger buffer in that then.
Yeah. If the anticipated bioavailability is realized.
Yeah
which we expect, they're going to land somewhere where they are today.
Yeah.
Right?
If in some weird world-
the bioavailability is dramatically lower, they both shift together.
Yeah.
Right? They both shift together. Yeah, that is the worst case scenario now. It used to be that the every three months was maybe an option.
Maybe an option, yeah.
The every other month was sort of the down the fairway.
Yep.
I think right now down the fairway is the every three months.
Yeah.
The very low probability is we'd have to use the every other month.
Yeah. That's right.
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.
Okay. All right. It's basically Bryson DeChambeau or Jordan Spieth's driver. Both of them are good on the fairway, right? Okay, very good. In terms of the 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, those things will be a lot bigger uptake, dramatic difference from the current drug is every month compared to every two months?
I think at every three months we'll probably put them out of business.
Okay.
No, I'm just kidding.
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. In our market research to date, there's definitely a difference, potentially dramatic. We're going to do some more market research and really try to get a full sense. Yeah, we're pretty happy with every three months. This is not my quote, but this is a quote from a single patient, so it's an anecdote of course, but 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.
That's a single anecdote. Yeah, I think it could be meaningful.
Yeah. Good. By the way, it's a high concentration, also low volume, which means you can do auto-injection. You are doing the bridging study, you will launch with the auto-injection of that.
Yeah, the full plan is to launch with the auto-injector, not with a needle injection.
Got it.
There'll be a needle in the auto-injector, but.
Not a-
To be clear.
Yeah, that's right. In terms of the economics, we know it's a different world, like Part D versus Part B. You mentioned earlier the decision already made very upfront mostly by patient or they just decide, "Okay, I want to self-inject versus I go to the office every six. I see you every six months anyway, right?
Yeah.
I wanted to be like How much economic to physician going to play into this decision versus the patient decision preference?
Yeah, it really shouldn't have any impact on clinicians and their economics and how they think about things. Again, 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. It really still is that threshold question in nearly every center. They're always going to ask that question. What's happening today, 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 BRIUMVI or just want the opportunity to be on BRIUMVI.
We haven't even talked about the differentiation of the molecules. Excuse me, that will come as well. That's something we haven't done yet.
Sorry.
In that 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 patients will say, "I wanted this as the CD20 option." Do you think that population, how small or how big that population could be? I'm thinking about expanding the current market versus taking share from others.
Expanding the overall CD20 market?
Yeah.
For people who-
Yeah
It's hard to say.
Yeah.
It's hard to say. As more products are available, the market will naturally expand. Community neurologists that don't have infusion capabilities is a pretty large area for expansion. It is expanding to those folks. They are using the SUB-Q. 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 the market's quite large as it is, and I do believe it will grow into some of those centers as well.
Okay, awesome. All right, we spent most of the time on the SUB-Q because that's fresh off the press, the data. No, 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. That's very encouraging. What will be the key drivers you keep pushing the IV? I did see quite a few times for the TV ads or some of the different platforms. DTC and then some of the campaigns. What's the secret sauce you can keep the momentum and get to the number one dynamic share in IV space?
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? 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. 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. Then the air game is what you're referring to, DTC.
We continue to experiment with different content different mediums of where we're going to, and we continue to narrow in on what's working best for us, and we continue to double down on those things. I think the combination of continuing to do our ground game the way we've been doing it with, I think almost at this point undeniably, the best field force in the business. Layer on top of that, the DTC campaign, doing it right. We brought in a great new team that are really just doing tremendous stuff in terms of revamping all of our content and our focus. The last thing is, and people have heard me say this many times, it's also building that social network effect.
Right? We have now, I think, upwards and over 25,000 individuals globally that are on BRIUMVI. It's still the smallest of the three in terms of that social network.
Critical mass is important. It's not just the largest, you need a critical mass. I think we're getting there, the more patients that go on BRIUMVI, future patients, more patients will go on BRIUMVI. Put the three pieces together, we just keep grinding away. Excitingly next year, we get to launch, hopefully with the positive phase III data for ENHANCE. 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. I think that we've probably been underselling that.
That in a launch scenario with new content, an invigoration of the whole program, I'm excited for that. I think it's going to be a really big event for the company, actually.
Absolutely. 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 a true SUB-Q at-home self injection.
You couldn't say it better than Adam.
Okay. You mentioned him a couple of times. He's the best in force in the market, so that's good.
Yeah. Thanks for bringing that up. I do appreciate it. Yeah, we think it puts us in a really nice competitive position. I think in the medium term, we're going to be the only company that's really in the IV 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 they can, and one has never been there. I think the advantage that we have, again, of having both, we've got a positioning that can put clinicians to say, "Do you want IV? Do you want SUB-Q?" They don't have to talk about anything else.
Yeah.
They can just offer BRIUMVI.
Either way. Yeah.
We know a number of centers have already said that that is their plan.
Then it'll 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.
Yeah.
Do you want SUB-Q? Do you want IV? We have one molecule, and we can get you on it.
Right. No pressure items. Every center just choosing BRIUMVI alone. Okay. Last minute, maybe anything else you want to tell? You have a ton of the earlier pipeline. It's absolutely not in the stock, and then you're not spending too much, but maybe that's all the upside and the optionality.
Yeah. Azer-cel is coming along. It was a little slow to start, but it's starting to really accelerate now. As we hopefully before year-end, get to a dose that is sufficient, and we can open up enrollment. The demand far exceeds our slots right now. Again, we've talked about this publicly. That is usually a pretty good sign that there's an unmet medical need in the marketplace, and that is certainly in progressive MS. We also opened up now, I think we have MG open, NMO open, CIDP open. We do think that there's real opportunities in all of those places, and they're all really commercially adjacent to where we're sitting today, so it makes it a pretty straightforward move into those spaces.
The last thing I'll say as I'm really thinking about adjacent spaces, SUB-Q, the lift for SUB-Q, this is not a situation where we have a new indication or a new drug and a new indication. This is 90% overlapping.
Yeah
sales effort, 100% overlapping and basically marketing effort. It's different, but the same pieces. We're not hiring new teams. We will probably hire some more access people because, as you mentioned, Part D versus Part B.
This is a highly leverageable opportunity.
with very limited associated additional cost.
Yeah. Simple story. You're going to win. Awesome. All right. Thank you, Mike. Thank you, everyone.
Thank you, Roger. Appreciate it.
Yeah.
Thanks, everybody.