Conference Transcript - TGTX 2026-06-09

Operator

Good afternoon, everyone. Thanks for joining us here at the Goldman Sachs Global Health Care Conference, including to everyone joining us virtually. Thrilled to have on stage with us today the Chief Executive Officer of TG Therapeutics, Mike Weiss. And maybe we'll just turn it to you to start with kind of an overview of the business, key priorities over the intermediate term. And I've been asking everyone, how do you think about core competencies of your business?

Michael (Mike) Weiss, CEO

Sure. Thanks for having us. Always delighted to be in lovely Miami.

Operator

In June, no less.

Michael (Mike) Weiss, CEO

In June. It's not so bad. I like the immunity. So, you know, at TG, we try to keep things relatively simple. We've got our ReUmbi now approved for elapsing forms of MS. We're about three and a half years-ish into the launch. Our target this year, I think, we're at $885 to $900 in terms of revenue guidance for the U.S. alone. And in terms of, you know, key priorities for the year, one is obviously continued commercial execution. that takes up a good portion of what we focus on and care about. We've had a few interesting readouts recently, so we have our enhanced study readout recently positively. That hopefully will lead to a label change in 2027 to simplify the onboarding. We'll talk about that, I'm sure, at some point. But day one, day 15 combination on day one simplifies the onboarding onto Brienvi. And then we also had some positive data around our sub-Q program. I'm sure we'll end up talking more about that, so I won't say too much, but hopefully that will lead to a new product line for us in sub-Q in 2028. And today we announced a small cohort of patients with MG and the start of a phase two potentially registration-focused study in MG. So I think it's continued to execute on our plans to get the label update for Enhanced 27 get to the sub-Q in 28 to carry through on the MG study while we, of course, just sit back to commercial execution, commercial execution, commercial execution.

Operator

We'll get to the MS thing, but just since it's breaking news, we'd love for you to spend a little bit more time on the MG data that you released today and kind of how it sets up a potentially registrational Phase II program.

Michael (Mike) Weiss, CEO

Yeah, so we're excited. You know, MG is something we've been thinking about for quite some time. we were able to get a small cohort of 11 patients into the Phase I sub-Q study. So that was really a nice addition for us. The data looked, I think, great, as great as you can get for 11 patients, to put it into context. Again, we're not talking about hundreds of patients. But I think it was just confirmation of effect, which we expected, right? It's no surprise that CD20s would work in a cohort of MG patients, so I think that was confirmation enough for us to move forward, both the historical usage of CD20s and this age in particular, which obviously we think is differentiated. So the 11 patients look quite good. On top of that, we came up with, I think, a creative study design to sort of meet a need in the MG marketplace. you know it's become a little crowded with fcrn and complement inhibitors which is great for patients but every time you add new therapies you end up opening up new opportunities and so we took advantage of the new opportunities uh you know the fcrns are dosed uh weekly and then intermittently and patients will go through these cycles of having very good responses on their symptom scores and then you don't treat them and their symptoms come back and then you treat them again you bring them back down on their symptoms and then they come back and so this episodic treatment one is I can't imagine it's great for patients to have to continually go back and forth with their disease and then when they are treated they're treated on a weekly basis we think Like, you know, Breon V could have the ability to maintain those really deep clinical benefit and just keep it there so you don't have to continually go back and get retreated.

Operator

So you're mentioning the kind of unmet need that you see in MG despite the competitive landscape. I guess, how are you designing the phase to study to make sure that you kind of prove out that it meets that unmet need?

Michael (Mike) Weiss, CEO

Yeah, so the way the study is designed is that all individuals will basically go through the four-week run-in for FGART.

Operator

FGART, take them on?

Michael (Mike) Weiss, CEO

If you could say it, God bless you, I can't really say the whole name, but FGART for short. They'll go through the standard four-week. and we expect about 70% of those patients, maybe 75% of those patients, will get a really nice response from that. And then right after that, we start the standard dosing of BriumV. We're using it experimentally for the moment, the standard approved dosing. But as you know from our sub-Q stuff, we'll be able to use sub-Q, assuming we're successful, somewhat interchangeably so we can then swap it out. I think the ultimate goal is to have the product profile be a sub-Q quarterly for that indication. So every patient will then, in theory, the patients that got the benefit will be down on their symptoms. We then treat the patient at that point, and the goal is to maintain those patients at that level of benefit. Perhaps we'll see some additional benefit. That would be great. And then the patients on placebo infusion, their natural course is to return to baseline at some point, whether it's 8, 10, 12, 14 weeks. One would anticipate they would return to baseline. And so it's basically a, you can look at it as almost a Kabel-Meier curve, right? It's going to be like a time-to-event analysis. And we think we have a really good chance of maintaining those patients.

Operator

And have you spoken with regulators and gotten alignment on the trial design, or where are you in that process?

Michael (Mike) Weiss, CEO

So from a registration standpoint, when you're using a phase two trial, there's really no alignment for regulatory purposes. I mean, obviously, it's an IND, it's a U.S. study. The FDA has looked at the trial, but in terms of whether it's registrationable is a later discussion, and it's going to be data-dependent for sure, and then obviously always becomes a review issue.

Operator

For sure. Okay, maybe we can turn back to the commercial execution, and like you mentioned, Breonvy launched now in its fourth year, guidance $85 to $900 million. I guess, what are the key considerations, and how do you think about formulating that guidance? And then kind of from there, what do you think of as potential drivers of upside or within that range?

Michael (Mike) Weiss, CEO

Yeah, so the nice part about the Breonvy business at this moment is we do get a lot of repeat business, right? This is a business where, you know, patients will continue, hopefully, to come back. I think, you know, we've always modeled, and we'll maybe talk about this, we've always modeled in about a median of five-year for treatment course. So there's a pretty large accumulation effect. So when we start a new year, at the beginning of that year, we have a pretty good sense of what the base business looks like based on our expected persistence and then the key variable on top of that is one you know to be continue to see that persistence right so that will change and then the new business that comes in every year and you know if you look at something like ocrelizumab you know the vast majority of their business is accumulated business right it has to be right there's not I mean you've got approximately I think it's 80,000 patients will seek a new treatment every year so that's the dynamic share about half of them will go on to a CD20 and then obviously within the CD20 class now there's three agents and it's relatively competitive for those 40,000 potential patients and so when you think about you know I think If ocrelizumab probably has 100,000 to 125,000 people on, their portion of the new market is going to be a fraction of the total. So, again, the two keys will always be, at this point, persistence. Are we seeing the same or better persistence than we expected as we go into the year for the patients who have already been treated? And then our market share gains.

Operator

so as you think about kind of the portion of sales that are derived from patients who are staying on therapy versus patients that are new to therapy where do you stand today in terms of the portion of sales that come from patients already on drug and where does that get to over

Michael (Mike) Weiss, CEO

steady state yeah so i i don't have the exact percentage but i do think if you look at you know something like norecalizumab my guess is at this point in the maturity now we're capturing market share. But the point at which you don't capture any more market share, my guess is it's an 80-20 split, give or take the base business to the new dynamic business.

Operator

So speaking on that market share piece, I guess, what can you share in terms of the share of the switch patients or the newly diagnosed patients, that 80,000 dynamic population that you talked

Michael (Mike) Weiss, CEO

about. Yeah, so that 80, again, goes down to 40 of the dynamic share for CD20 class. And within that class, I mean, the last time we said something publicly, we said we were approaching about a third of the IV business, which translates to about 20% of the overall business. That market share has been growing. We haven't updated the number with precision. And some of the precision is somewhat challenging because the quarter to quarter, the dynamic share does change. It's not a linear 10,000 per quarter for the year of the 40,000, so it's not perfect linear, but within that context, you know, we did say that the first quarter of 26 was our best enrollment quarter ever, and I'm highly confident that we'll see another record quarter in 2Q.

Operator

Great. In terms of the kind of revenue trajectory from here, 2027 consensus is north of a billion, so blockbuster status in year five but you've said that the peak opportunity is still multiples from where we are today do you be more specific about kind of how you're thinking through the peak opportunity and in particular as well the path to getting to peak like how long will it take

Michael (Mike) Weiss, CEO

yeah so not so long as short i mean we will be at you know our projections are that we'll be at a run rate a billion dollar run rate before the end of the fourth year of

Operator

of sales. That's a little bit faster. Run rate versus full year.

Michael (Mike) Weiss, CEO

We're on the same page. We're on the same page, yeah. We are on the same page and obviously comfortable with those numbers where we stand. Of course, if we end the year with a run rate of beyond a billion, we certainly think next year is north of a billion dollars in sales. We haven't given any, obviously, specific guidance. But what we have said and I think you're alluding to is in our last conference call. When I talked about the IV business alone, I said I thought we were years and multiples away from peak, just of the IV business alone. And so with IV business tracking toward 885 to 900, multiples of that in years away, again, I don't have the exact year, but I could tell you that but it's not anytime soon, which is a good thing. But it will be approximately five years after we stop taking market share. So when the dynamic share flattens out, and I'll just pick any number. Let's say at some point we are 50% of the IV dynamic share business. And so for the IV business, once we hit that point, if we don't keep growing it, holding aside the fact that probably the overall market is growing, But putting that aside, just holding constant, the entire market is not changing. At the moment we hit our peak market share, we're probably five years of accumulation away from steady state, right? So that would be peak. So that doesn't include, obviously, where we are with IV, but so that's the, I mean, with sub-Q, so that's the IV portion of the market. So I do think we are multiples away from the peak and years away in that context. And I believe that we will continue to gain market share over the next, you know, three to five, minimum three to five years, and probably longer.

Operator

Okay, great. You mentioned at the top that you have a few more kind of convenient dosing strategies in the works, including the enhanced profile as well as the subcutaneous product. Why do you think it's important to have these offerings to physicians and patients, and what do you expect that to drive in terms of share gains?

Michael (Mike) Weiss, CEO

Yeah, so it is important to focus on the patient and the experience. I think it's like Maslow's five stages of realization, right?

Operator

Maslow's hierarchy of needs.

Michael (Mike) Weiss, CEO

Thank you. Yes. So at the beginning, you just got to make sure you've got food and shelter. And that's, of course, if you think about it in a treatment landscape, you just want to give someone something that helps them. And then you want to improve upon how it helps them, but you also just want to make it easier for them to enjoy their lives, right? So the more we can optimize the process for what we believe is a best-in-class drug, the easier it is for folks to enjoy the benefits of it. So removing the day 15 dose to, I would say, somewhat to our surprise, We continue to hear really positive feedback from both patients and from clinicians and centers. So, yeah, we just think it's important to continue to think about the patient experience and the journey.

Operator

Maybe we can talk a little bit more about the subcutaneous product because you did just have bioavailability data last week. I guess, again, on that question, you know, what is the role that you see subcutaneous offering playing in the market? Why do you think it was important for you guys to participate there?

Michael (Mike) Weiss, CEO

Yeah, so, you know, the market for CD20s, as I talk about those 40,000-ish patients, and that is growing, it's not linear growth. Some quarters is a little lower because I said it's not, every quarter is not the same, but the trend line is growing. So there are more patients than that 40 that will continue to come into the system, but it's just easier to keep that constant. So of those patients, one of the threshold questions after a clinician decides that they want the patient on a CD20 is, do you want to self-inject or would you like us to do it for you? About 35% to 40% of patients are choosing to do it themselves. If they choose to do it themselves, we don't have a product that can compete in that marketplace today. So we're not talking about some sort of brand extension. This is literally a new, you can almost view it as a new indication of this group of patients that we currently don't have access to. So that's why it's so important. So that's why I say sometimes this could nearly double our addressable market.

Operator

So maybe you could now review the data that you did share from the Phase 1 in terms of bioavailability data and speak to how that then could translate as we look to Phase 3 results later this year.

Michael (Mike) Weiss, CEO

So the data that we presented was bioavailability information and data from our phase one study. The simple portion is that the, it takes a lot of data to get an answer, but the answer is that it's about 60% bioavailable. So when you give it into the subcutaneous compartment, about 60% of that material will make it into the vein. So all you have to do, I make it sound very simple and took a lot of work on the team, But in essence, all you really have to do is come up with, put enough material in, so when you lose 40% of it, 60% makes it into the blood, and that is an equivalent amount to what you're giving IV. So it doesn't have to be complicated. And if you do that, and we're giving, just to put the numbers, we're giving our quarterly regimen is 400 milligrams on day one, 400 milligrams on day 15, 400 milligrams on day three months, whatever, right? So that's 1,200 milligrams given in the first six months. We're looking at the AUC, zero to 24 weeks, so the first six months. That is the same. That is to match off against our IV dose of 150 milligrams on day one or 50 or 600 total milligrams. 1,200 times 0.6, 720, divided by 600, comes up at 1.2. We have very fancy models that came out with 1.21. I mean, it's almost hard not to, if you put it in, it's hard not to get an AUC that matches if you know the bioavailability. So that's where we are. The study is designed, the phase three study is designed to look primarily at non-inferiority, which means that you have to have instead of what I calculated as a 1.2, you have to be above 0.8, right? So for us to see bioavailability drop so low as to see 1.2 turn into 0.8, So you'd really be, based on the confidence intervals around the information we have today, you'd really be in a tail, if you think of a normal distribution curve, you're way out on a tail. If that were to happen, which we think is highly unlikely, we still have the every other month, which would shift from 1.58, would go straight on down and would land directly in the profile. So between the two, we've got a lot of safety margin. We think we have a ton of safety margin, obviously, around the quarterly.

Operator

Just to confirm, once you get past the loading dose, is the math kind of, like, any changes to the way that math works?

Michael (Mike) Weiss, CEO

You get 400 milligrams every three months. And again, in the second half of the year, just to give you a sense, you've got 400 milligrams, 400 milligrams, matching off against 450 milligrams. So you have 800 to 450 times 0.6. You're going to land in a very nice location across the board.

Operator

And in terms of, like, form factor and tolerability, What can you share about the amount of volume that you're administering with this subcutaneous and what you saw from a tolerability perspective in that data?

Michael (Mike) Weiss, CEO

Yeah, so we're using a 2-ML injection. It fits nicely into an auto-injector. The first study that we reported is from, you know, clinician, you know, injecting the 2-MLs where we said that we'll be doing a bridging study, which should start relatively soon, to bridge from the injection, the 2-ML injection by a clinician, to an auto-injector injection. So 2-ML is a good number there. And then in terms of the tolerability, I think we saw two injection-related reactions, which were, I think, mild to moderate. I can't remember what we said on the record, but it's pretty minor. I mean, we did, I think, about 225 injections. Over 80% of them were at the 2-ML volume, so not a lot of injection site reactions. And then the systemic injection reactions, so more like IRRs, was also like 20%, which is actually really consistent with what we saw in Enhance for both arms, essentially, at about 20% infusion reactions.

Operator

Can you frame this first, the competitive landscape? You mentioned already that about 35% of patients are getting sub-Q today. How do you think every 12-week kind of dose would fit relative to the competitive set?

Michael (Mike) Weiss, CEO

We think it'll be really well-received. The current competitor is at one injection per month, so 12 injections per year. This would take the injections down to four per year. We think, you know, in our research, you know, four versus 12, you know, there's a pretty stark market share benefit to us. the competitor is working on every other month a product. We still think less is always going to be better and we haven't even started the process of comparing lubituximab itself versus ofatumab. So we've spent a lot of time because we compete against oculizumab, we've spent a lot of time differentiating the molecules. We've spent almost no time because we don't compete today against ofatumab. So once we start to showcase some of those differences, and it's quite interesting too, because while Ocrevus is a little bit, I'm going to call it dirty, it's not really dirty, but it has dual, really has a pretty balanced mechanism between ADC and CDC. Ofatumab has been engineered specifically to have high levels of CDC and almost very low levels of ADCC, whereas we were engineered the exact opposite, to have really high levels of ADCC and very little level of CDC. And I think once we start to engage with clinicians on the differentiation between the molecules, I think that plus the convenience factor puts us in a great position to do what we believe we can do and what we want to do is to be the number one in the southern sub-Q marketplace. We want to be number one overall CD20. We're on our way on the IV side, and we're looking forward to hopefully being very disruptive in the sub-Q side.

Operator

And so then as you think about where the subcutaneous market could go relative to the CD20 class, I guess, how do you think introducing a 12-week could change sort of the share from a broader class perspective?

Michael (Mike) Weiss, CEO

It is hard to know. We do think there are dynamics that over time may push more of the market out of the infusion suite and into the homes. There have been and continue to be site of care issues with academic centers. I think you'd be shocked to know that in some or many academic centers, the charge for the infusion service itself exceeds the price of the drug. Process that for a second, if you will. So in those cases, you will see that the insurance companies will push outside of those centers. Now, a lot of times they'll end up at an AIC, an independent infusion center, but a lot of times that will just, the clinician may at that point use a sub-Q product. So the more and more that the insurance companies push those site of care issues, the more you'll see drop-off into sub-Q use or fall off into sub-Q use.

Operator

How should we think about pricing for the subcutaneous product relative to the IV? Kind of with that in mind, there's a different kind of cost dynamic, et cetera.

Michael (Mike) Weiss, CEO

Yeah, so I guess the first thing to notice is that with the bioavailability being different, just on a milligram per milligram basis we're using I can say almost double because I can't do the math on 60% but it's 40% whatever that inverse relationship is but we're using a significantly more material so on a milligram per milligram basis and that market is different ofatumab is priced at a very different price point than the IVs and there's different rebate programs. So we're going to have to review the pricing in the context of the marketplace that we're going into, but also based on the milligrams that we'll be delivering.

Operator

One of the things that you did when you came into the IV market was compete with Ocrevus on price. Is that something that you think you would need to do here in this opportunity setting, particularly given the differentiation we talked about on the clinical side?

Michael (Mike) Weiss, CEO

I think we're still evaluating. One thing that the team did do successfully, and you're alluding to, is we did take price against ocrelizumab. And, you know, I'd like to say it was something that was targeted at ocrelizumab, but really it was targeted at the payers, right? And the idea was we wanted to get, I'm going to call it, great coverage as early as possible right one of the hardest things is at the time of launch if you get clinicians excited and they can't use the compound you kind of lose them right then it takes them a little while to come back and they have a a recollection of the challenge that they had and so even to this day there's some clinicians who maybe start early and we'll talk to them and say, yeah, it's harder to get to. I'm like, no, no, no. That was the first three months. We're three and a half years in. Across the board, we pretty much have parity with ocrelizumab. There are some places where we do have priority, but overall, we have parity, and that was the team's goal. The team did a lot of research, and they believed that coming in at the lower price would get us early access. They were successful. I think within six months of launch, we were at 80% coverage, and within a year, we were

Operator

over 90 percent um you have the best patent estate across the cd20 therapies with duration into the 40s but as these biosimilar products come to market for the other agents in the category i guess what do you expect to see in terms of how that changes class share dynamics yeah i've often

Michael (Mike) Weiss, CEO

said tongue-in-cheek that as you know our goal is to be the number one anti-cd20 in the marketplace and if we don't get there before Ocrelizumab goes biosimilar we'll certainly be there after so I think that in a tongue-in-cheek way of me saying we firmly believe that a tailwind will be Ocrelizumab biosimilar to us generally speaking in this marketplace prescribers prefer not to use generics or biosimilars we're starting to see this dynamic emerge with Disabri today, we see a lot of switches from Disabri for clinicians who are being forced to go on to the biosimilar. We anticipate something very similar will occur. And, you know, in terms of pricing, we're already at about a 25% discount to the price of orcalizumab. Most biosimilars don't even come in that low so there's not a huge economic incentive for them to go cross category to step through for us there is a lot of incentive for them to get as many patients off of vocrolizumab and not to biosimilar because they can immediately save that 25 or 20 percent whatever the biosimilar comes in on pricing but to go cross category there's not an economic incentive from price, and also you're talking about a franchise that we'll have in place that, you know, they'd be giving up a lot in volume, our volume and our price to go to something else.

Operator

Maybe you could speak a little bit on the OPEC side, I guess, in terms of near term, any additional investments you feel the need to make, either on the DTC side or in terms of commercial infrastructure, and then how should we think about that as you look forward in bringing a subcutaneous product to market over the next couple of years?

Michael (Mike) Weiss, CEO

Yeah, so just in terms of where we are today, you know, we launched with a, I'd say, relatively modest commercial team, but mighty. We hired really some of the best people in the business, but relatively small on comparison. Would they plan that we'd continually grow out that as the demand required, we would continue to rise to the occasion? We've continued to do so. So we've built our team. I think our commercial team is in a great place right now. We continue to look for opportunities to optimize certain, whether it's geographies or even down to places, right? So if we see that we're doing great in one city but one center isn't performing because we don't have connectivity there, if we could find someone who has connectivity, we'll go ahead and hire that person. and we can overlap from a geography standpoint. But for the most part, we've got a field team that's operating at a high level. And like I said, I think if we see the opportunity to improve, we'll continue to add people. So that's the field for us. And so it continues to grow modestly on a year-over-year basis. The big toggle is DTC, right? That's something that you could spend, like our competitors, you know 100 million plus um or like us something in probably the 25 to 50 range right so we could toggle that up at any point that we want to and we do we toggle we toggle up and down as we see things and opportunities uh and we continue to experiment i mean we don't think that it has been figured out yet what the optimal across the whole industry i mean the pharma companies their simple model is just throw the spaghetti against the wall and see what sticks and for the most part if they're going to get an ROI above one, right? So it's not going to be zero. They're going to get an ROI, but we're not playing for a 1% ROI. ROI is dramatically higher. So we'll continue to look for opportunities to continue to build that out. And so that is the big OPEX toggle. You could spend a lot or you could toggle it back down. And as we see opportunities or we see things that are working, we'll lean into them. So that's where we are on the DTC. And then you asked about how does that change as we move into sub-Q. So from a field force perspective, sub-Q is really overlapping with what we're doing today, right? We have, I think we've calculated that probably 80%. We're covering about 80% of the sub-Q prescribers with our current field force. So really highly, you know, from an operational leverage perspective, I mean, this is different from, you know, even different from MG, which is pretty darn good. We've got a lot of overlap there. But, you know, it's not like going into a whole other area. You have to rebuild the entire machine. This is, you know, very incremental OPEX on top of a full, almost equivalent opportunity set. So that, but then DTC, again, is the toggle, right? It's how much do we want to do to promote and what makes the most sense? So that will be incremental, but it will be somewhat probably substituting, right? Because the brand is the brand, right? We'll be the only ones who have both products in the marketplace. So even as we're DTCing the sub-Q, we're selling the IV, right? If a patient comes in and is asking about BriomV, they're still asking about BriomV. And the clinician is going to direct them in the preference that they want.

Operator

So with that in mind, you're looking at relatively significant operating leverage and cash flow generation over the intermediate term. I guess, how do you think then about allocating that capital across shareholder returns, business development, investing in the pipeline?

Michael (Mike) Weiss, CEO

Yeah, the easy way out is to say all of the above. Easy answer is all of the above. So I'm not going to say that, although I just did. Yeah, I mean, we've been, I mean, I think of companies our size, we've been very quick to start with the repurchase program, right? We recognize that we are going to be generating significant cash flow over the coming years. And, you know, buying our shares inexpensively where they sit today versus waiting to buy them in a few years at much higher prices, we thought was a good idea. And we leveraged up to do that. Having said that, we still have, through that leverage, we have enough bandwidth to look for new opportunities, which we continue to do, and of course invest in the pipeline and what we have in front of us. We don't feel at all restricted by cash. We feel like we have access to unlimited cash to do whatever part we want. And so if we see a business development opportunity that is a great deal and we think we can generate a high level of IRR, we will do that. If not, we know that we have a high level of IRR embedded in our repurchases. We'll continue to do that. But, yeah, I think we're poised to use that cash flow judiciously, cautiously. Again, we've been talking about doing BD deals for a very long time. We've executed one in Azercel. which you haven't talked about. So we talk a lot. We review everything. There's not one deal that's been signed that's close to MS over the last few years that we didn't, we weren't probably, we were the preferred partner and we chose not to do it.

Operator

Well, with that, I think we're at time. Thanks again for joining us.

Michael (Mike) Weiss, CEO

Thank you. Yeah, appreciate it. Great to see you.