For you, for those who don't know me, I'm Michael DiFiore, one of the Senior Biotechnology Analysts at Evercore ISI. I had the pleasure of hosting TG Therapeutics. With us today is Michael Weiss, CEO. Michael, welcome. Thanks for coming down to Miami to be with us.
Not so hard to get me to Miami.
I know you're local, but before we delve into Q&A, perhaps maybe just give us an overview of the business and what to look forward to in the next 12 months.
Yeah, so we've got a lot of things going on. So the Briumvi has now been on the market, I think, two and three quarters years about. So I think we'll have our three-year anniversary basically in February of next year. So things have been going great. You've reported on it quite well in your research. I think we're targeting right now for this year $585 million in revenues. We have not yet provided guidance for next year, but we obviously believe we'll be a significantly larger number than that for next year.
In addition, we've got our consolidated dosing study up and running, and we've completed enrollment. That should get us data sometime middle to early second half of next year. Our sub-Q program is also up and running, enrolling well. I think we should complete enrollment sometime in the first half of next year with data toward the end of next year. Yeah, things are going well. We've got some good news coming. Hopefully good news, but we have news at some point next year, and the revenues should continue to ramp.
Great. Now, thanks for that, Mike. Just to kind of delve into the CD20 MS market, just based on the current stats that you routinely give on your calls, roughly 50-55% of MSs go on CD20s.
Yep.
Right? And now the Sub-Q portion is now 35%-40% of that, which means IV is around 60% of that, of the dynamic share.
Yep.
Briumvi is capturing maybe one out of three new IV anti-CD20 patients, correct?
Yep, give or take.
That implies that IV Briumvi has about a 20% share among the CD20 class and about a 10% share among all MS new starts. Would that be correct?
Yeah, I mean, the numbers are the best numbers we have, but yeah, that's about right.
Okay. I'm going through this because patient awareness, at least back on your August call, was around 35%, and 3Q was your first quarter of DTC. What's the patient awareness level now? Do you have any updated numbers?
I do not yet, no. I'm actually excited to see that data. We usually run that about every six months, so it hasn't been run again. It will be run soon, I think, in the next month or two. We'll get that number. I don't know where it stands today.
Got it. Maybe perhaps speak about how should we think about the trajectory of increased patient awareness and how that could potentially translate into increased share gains.
Yeah, so it is definitely an interesting question. I think it is the question. I mean, I wish I knew exactly what the answer was.
Right.
I'd know exactly how much to spend on DTC to get to the exact greatest level of penetration. I guess taking your numbers that you gave today, again, I think they're in the range for sure. We're at 35% awareness and 10% overall market share. That's about three and a half to one ratio.
Right.
Our goal is certainly to improve that 35%. I think our internal goals are over the next year or two to double that type of thing. I guess we'll have data going forward to see how that all worked out for us. I don't think we have any data yet, but as we roll out, we'll be able to track the change in share gain to the change in awareness gain and see how linearly correlated they are versus some lag and some differential. Right now, like I said, it's about three and a half to one.
I mean, let's put it this way. If we were able to double the awareness and that would double the market share, if that were the case, that would get us about 40% market share in the CD20 space. Our internal goal has been and continues to be to be the number one selling CD20 by dynamic market share. I think 40% gets us pretty close, right? Let's see what happens. I mean, we're out there. I think we're taking a good crack at it in terms of the DTC and trying to change that awareness.
Hopefully that awareness, if we maintain this ratio and we double the awareness over the next two years and we get to, and if that does translate to exactly where it is today and we get to that 40%, that'd be pretty wonderful.
It may not be linear, right? It may be kind of almost exponential.
Could be slightly.
Yeah, slightly.
I mean, I would love for it to be exponential. We'll see when we get there, but I'll definitely report back to you. I like the question. I like the thought process. Let's give it a go.
Okay. As TG plans to expand its sales force a bit more, I mean, which definitely should optimize prescriber breadth and depth, will these newly added reps focus more so on private practices in order to balance out the growth in this subsegment? Because I think before you were saying the hospital subsegment is kind of really kind of outpacing growth in terms of just growth.
Yeah, but the hospital had some catch-up to do, right? I think overall, what I'd say is we're doing great in the community setting, the big practices. I think we're probably the second most prescribed in that setting today and growing. I would imagine the sub-goal will be to be the number one in that category before we're number one overall. No, the purpose of the expansion is really to pinpoint, there could be community practices, but also academic centers, just pinpoint where we're having weakness, right?
I think most pharmaceutical companies, when they do expansions, it's like, all right, we're going to go from 50 territories to 75 territories to 100 territories. It's really just a geographical split. They just keep splitting the pie. Ours is definitely more of a rifle shot approach where we're looking through the territories and saying, hey, within this territory, these three centers are not performing for us and why. If we think there's a person who we could bring on to help make that happen, we would do that. It is really very selective, very focused, very strategic in how we do it, but it's not a scattershot approach. We just don't split territories for the sake of splitting territories.
Got it. You can't simply say that we're going to expand the sales force by 10-20%. It'll be a very kind of pinpointed target approach and opportunistic.
Yeah, it's opportunistic. I don't know exactly. I mean, my guess is it's probably in that range that you're saying, but that's because I think that's what we've identified as where we want to go for this year. I think they've done the work. I'm actually going to find out on Thursday exactly what it is. I don't know yet. I can't preview it with you. I'm getting the look at it on Thursday of what they're planning. I think they've already identified where they want to go and they're working on creating those hires right now.
Okay. So that this will conceivably be completed by middle of next year.
Yeah, I would assume they'd have the people that they're targeting now, they would have on board by middle of next year for sure. I mean, hopefully even by our national sales meeting, which is in the first quarter.
Got it. You said the hospital segment kind of needs to catch up. As we think about how this segment continues to grow, the hospital segment, does this imply kind of an increased gross-to-net spread due to 340B discounts or no?
I think intuitively the answer is yes. The one thing I find interesting about the whole conversation about gross-to-net is it's not a universal number that just gets applied to all revenues, right? When we talk about the hospitals that are getting 340B pricing, yes, they get a better price. There's a government-mandated price that they get. Basically for them, it's a volume price trade-off, right?
You're getting more volume, but it's basically at a lower price point for them. It doesn't affect any other part of the business. Everyone else is paying whatever they were paying all along. We always report obviously a net number. I mean, the gross-to-net will change based on the proportion of 340B sites. I mean, yes, for sure.
I guess final IV commercial question. What's the current breakdown of, I guess, patients in terms of switches, new starts, things like that?
Yeah, it has been remarkably consistent. I mean, really amazing that, I mean, I think if we took the numbers from the first month of sales and we looked at the numbers today, within probably three or four percentage points tops on each and one of those categories change. It's been a really, really tight range across. I don't think we've ever given out the exact number. I don't know why. I mean, we've always felt maybe we just wanted to keep that for competitive reasons. I'm probably not going to say it right now exactly.
What was always described is that there's patients who are naive to all treatment and that bar is about here, let's say. Then there's, for those of you at home listening in, I put my hand up about this high. Super helpful. I'll make it more descriptive momentarily. There is another group that has come to Briumvi from every other treatment that is not a CD20. That is the middle bar and that is the highest bar, right? That one is the highest. You have the final bar, which is the patients come from other CD20s. That is the second highest bar. I do not think any of them are more than a 10% delta from each other.
I see.
It is not completely flat across, but it is pretty tight to flat across. Like I said, within a 10, I think a 10 delta across the board, no more.
I see. Okay. I want to move on to sub-Q Briumvi. That gets a lot of, I get a lot of inbounds on that. I think I asked on one of the calls, when might we see phase I PK data? Is that still on the docket for next year sometimes?
Yeah, probably second half of next year.
Second half of next year.
I forgot what we were saying, but the team is, I know the team was extremely busy getting that study up and running, the pivotal portion, which is why they didn't go back and do a presentation of the phase I. I think I've talked to them. I think they're going to probably put it together. Sometime probably in the second half.
Okay. The phase three study that's underway, three arms, placebo every two months and every three months. Are you developing the formulation in-house? I mean, to what extent can you hyper-concentrate this product? Are you able to say?
I can't give you the exact number, but yeah, I mean, the team did an amazing job concentrating the molecule. Yeah, it is a highly concentrated version of Briumvi or ublituximab. I don't know what you'd call it at this point, but it's a highly concentrated product. Remember, we have said that we want to make sure we can put it in a 2 ml auto injector. Think about it. I think today we've got 150 milligrams in 6 ml.
Presumably, we probably have higher concentration, higher milligrams in a 2 ml concentration. You could see that it's been highly concentrated. Yes, all the formulation work was done in-house. It's a proprietary formulation that our team created. We have provisional patents filed on that formulation. If they issue, which I feel pretty good that they will, we'd have patent protection out to 2045.
I see. I see. In that light though, a lot of attention was given in the past few months on CMS and how they treat, I guess, formulation changes. I cover another company that the CMS IRA negotiation part is very, very relevant to. In terms of what I'm getting at is that with a new sub-Q formulation, I mean, will that be kind of linked to the launch of the IV brand or being a new sub-Q formulation? Will that have its own IRA clock? Any thoughts on that?
I believe it should have its own IRA clock. I mean, we do not know. My guys are telling me we do not know yet. I will keep you posted on that. It will be filed as a new BLA. It will be a new brand.
Okay. Assuming it does launch in 2028, and by then sub-Q Ocrevus, Kesimpta will be very entrenched at that point. Will you need, I guess, any other data to help gain formulary positioning or coverage to kind of compete there or no?
I mean, there's a lot to unpack in what you just said. Yeah, I mean, certainly Kesimpta is entrenched in the sub-Q market. Sub-Q Ocrevus, I think that'd be an optimistic statement to say that it's entrenched and whether it will or will not be entrenched at that moment. I think we'll let that one unfold as it may. Remember, that one is a physician-administered product. It's not in the same space as we'll be competing with Kesimpta.
I think the short answer, although now it's actually a long answer, is no. Our expectation is that we would seek as we have with IV, where we did have two very entrenched competitors at that point. We're just looking to start with parity coverage. I don't see any reason why we wouldn't be able to achieve that.
I see. I see. Fair enough. Fair enough. The sub-Q segment is roughly 40%, as we said before, of the dynamics here. Could this conceivably go to 50-60% in a couple of years? Where do you see it going?
Yeah, we're having trouble figuring that out, to be honest. Where exactly it's heading. Even quarter to quarter, it ranges actually between 35-40%. So it's not a consistent, it hasn't been like a consistent trajectory up. It's definitely had some fits and starts. Again, the long answer is, after a long answer, the short answer is we're not sure. It is possible. I mean, again, the good news is assuming we're successful, we'll be the only ones that have an IV product and a true sub-Q product. I guess at that point, we'll be indifferent to how that market shakes out. It is today, I think, impossible for us to answer that question.
Fair enough. Fair enough. Just a quick one on Azer-cel. Thoughts on Azer-cel and perhaps cell therapies in general? Their competitive positioning in light of Roche's positive PPMS data that was recently reported?
Yeah, you put positive in quotes, right, when you said that?
Air quotes?
It's air quotes out there.
Positive press release at least.
Yeah, yeah. I mean, so they proved that they were non-inferior to Ocrevus, which is great. It's the only thing approved for primary progressive MS. Having said that, I think most clinicians view Ocrevus as marginally beneficial. I mean, it's certainly better than nothing and that's great. I think we were looking for hopefully something that would be really advancing the field and medically changing the outcomes for these patients. I assume, and I don't have 100% certainty, but I can't imagine any reason that the statisticians who evaluated that study would not have built in a step-down analysis to superiority because there was a zero alpha spend to do that.
If we assume that that happened and they announced that it was non-inferior and not superior, we have to assume that it definitely was not superior, right? That product is unfortunately for me personally and I think for patients with PPMS, not the major advance that people were hoping for. What's the promise of cell therapy in this area? I mean, hopefully the promise is something a lot more than that. Something that really makes a major impact in the field for these patients who are continuing to progress, whether they're on Ocrevus or it sounds like BTK will be the same, they're going to continue to progress.
We don't have anything that's, in some of these autoimmune diseases with CAR-Ts, we've seen some really dramatic effects. It's not every patient like it started, right? We get that. I think anyone who believed that it was going to be a 100% response rate for CAR-Ts in every autoimmune disease was a little bit delusional. The potential to have that kind of an impact on patients with MS, particularly progressive forms of MS, that's the goal. That's the dream scenario, right? We're not there yet, far from it. Yeah, I don't think it changes the competitive landscape at this point.
Got it. In fairness too, I mean, we haven't seen Roche's safety data yet.
Yeah, that's a whole another story.
That's a whole nother conversation.
Yep, absolutely.
Just a real quick update on Azer-cel's phase I?
Yeah. I've got my fingers crossed that 2026 is going to be a big year for enrollment. We've been slowly ticking away. I think we're on our fourth or fifth patient treated, still working from very, very low doses up. Fingers crossed, we're hopefully reaching a point where we can have more of an open enrollment phase. I think hopefully in 2026 we'll see some more rapid enrollment. So far, I think the patients are doing as well as can be expected.
Hard to really tell with a handful of patients. Yeah, I'm keeping my fingers crossed. Hopefully there'll be, there's a, I think a reasonable chance we'll present some data, also probably in the second half of the year when we accumulate some more information, some more patients. Yeah, I think overall, I think it does have the promise to do something material for these patients, but it is too early.
Yeah, I understand. Okay. Perhaps last question. Just for a company TG size, like running a global IV and sub-Q franchise and a CAR-T platform and autoimmune pilot studies could strain bandwidth and execution. I mean, how should we, that'll be a good problem to have, I guess, in some way. I mean, how should we think about prioritizing resources if this situation materializes in the next maybe five years?
Yeah, I mean, I think from, so there's the commercial side of it, which I think we're good. We've got an expandable platform that can easily handle the sub-Q launch. As we think about other indications, as you refer to both for potentially for Briumvi and also potentially for Azer-cel, we'd have to expand on that, both on the clinical side and on the commercial side. I don't see anything that is so dramatic in front of us that we can't manage it.
For better or for worse, on the R&D side, you can outsource to CROs, right? You don't have to build an additional team on the R&D side. You can outsource some of it. It's a little more expensive, a little less efficient, but you can get it done. If we had to do those things, we could add it on the R&D side if necessary. Commercial side, we would not be outsourcing. I think we just scale the commercial team as necessary.
Got it. Unfortunately, that's all we have time for, Mike. Mike, this has been very helpful. Thanks for spending time with us and we should look in the future.
Thank you. Really appreciate it. Great to see you.
Thank you.