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On Tuesday, 10 June 2025, TG Therapeutics (NASDAQ:TGTX) presented at the Goldman Sachs 46th Annual Global Healthcare Conference 2025. The company discussed its strategic initiatives and future growth plans, focusing on Breumvy, its commercial-stage drug for B cell diseases. While TG Therapeutics highlighted positive developments in market share and innovation, challenges remain in expanding their pipeline and maintaining competitive positioning.
Key Takeaways
- TG Therapeutics is committed to growing its market share in the CD20 therapy space, focusing on Breumvy’s performance and patient experience.
- The company is investing in marketing and development, aiming to enhance Breumvy’s dosing and formulation.
- A share buyback program is underway, reflecting confidence in long-term growth.
- Future expansion includes potential new indications and partnerships, particularly in neurological conditions.
- Financial guidance for Breumvy’s full-year revenue is set at $560 million.
Financial Results
- TG Therapeutics provided a revenue guidance of $560 million for Breumvy in 2025.
- The company’s revenue drivers include new patient starts and persistence in treatment.
- A share buyback program has been initiated, indicating a focus on shareholder value.
Operational Updates
- The company has achieved parity in formulary coverage with competitors such as Ocrevus, with some plans preferring Breumvy.
- TG Therapeutics has doubled its field force since the drug’s launch, leading to increased market penetration.
- Marketing efforts have expanded to include online platforms, testimonials, and connected TV commercials.
- The company is working on consolidating Breumvy’s dosing to a single day and developing a 30-minute infusion option.
- A subcutaneous formulation is in development to compete with at-home injection options like Kesimpta.
Future Outlook
- TG Therapeutics is exploring new indications for Breumvy, including MG, and is investing in a CAR T program.
- The company is targeting neurological conditions such as NMO and CIDP for future pipeline expansion.
- A subcutaneous formulation with potential for Q2 month or Q3 month dosing regimens is being developed.
Q&A Highlights
- An unidentified speaker emphasized the importance of realistic performance estimates and the company’s goal to lead in dynamic market share for CD20 therapies.
- The company remains open to new product opportunities and partnerships that align with its strategic goals.
For more detailed insights, readers are encouraged to refer to the full transcript below.
Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference 2025:
Unidentified speaker: We just click we’re having a conversation.
Unidentified speaker: Yeah.
Unidentified speaker: Awesome. Good morning, everyone. Thanks for joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined here today with the team from TG Therapeutics. Maybe I’ll let you start with a quick overview on the company, and we can go from there.
Yeah.
Unidentified speaker: Sure. Thanks. And great to see you. So TG, we’re a biotech company, commercial stage at this point, focused on B cell diseases. We have a drug on the market, which is called Breumvy.
We’ve been on the market now about two and a half give or take. Things are going well. I’m not gonna say too much because I I know I’m sure you can ask me a of questions.
Unidentified speaker: All my questions. Yeah.
Unidentified speaker: Steal your questions. Things are going well. And and beyond that, we have some, I guess, improvement programs to BRIONVI
Unidentified speaker: Mhmm.
Unidentified speaker: And enhancements. And then we just do also have a a CAR T, c 19 CAR T in the pipeline.
Unidentified speaker: Perfect. I would love to start with the BRIONVI launch. You mentioned it’s well into the year. It’s gone really well. Guidance of 560,000,000 for the full year.
So I guess how do you think about guidance, and and where do you kind of get conviction in the numbers you put out? And can you describe kind of what are the puts and takes in terms of achieving that?
Unidentified speaker: Yeah. So there’s a matrix that the team puts together. There’s probably six variables that they look at. But to be fair, there’s two that are really driving most of it. Mhmm.
You’ve got new starts, and you’ve got persistence of
Unidentified speaker: Mhmm.
Unidentified speaker: Individuals who’ve already been dosed. Beyond that, you’ve got things like gross to net. There’s a few others. I’m drawing a blank for the moment. But but primarily, they’re driven by the the two new starts and and persistence.
And in terms of, you know, the way as a company, I think we think about guidance is, you know, we feel like the worst thing we could do is is misguidance. Yeah. So we we try to do the best we can. We do know I mean, one thing the the only piece of information, I guess, we do know for sure is how many people that are on or supposed to be coming back.
Unidentified speaker: Mhmm.
Unidentified speaker: And we have a rate of new patients that are coming in and and hopefully continues to grow. And you try to put those two numbers together. You can get a range. You can get a target. We sometimes do ranges.
We sometimes do a point estimate target. But I think the goal is to to definitely not miss. But I will say that at the time at the moment that the team gives me the the estimates, it really is the point estimate is really the number they have the most conviction in and belief. And then, hopefully, there’s very little of a downside tail. Mhmm.
Perhaps maybe a little more of an upside tail, and we’ve seen that in a few quarters. Yeah. We’ve we’ve seem to have beaten sometimes modestly, sometimes a little more than that. But, typically, the the center point, I think, for investors to know is that, you know, we’re not taking risks with the number. Mhmm.
But we do believe at the time we give it, it is the the number that is a number we really believe in.
Unidentified speaker: Yeah. Right. You mentioned that the two key components are persistence and new patient starts. Persistence, obviously, something you can kind of know a little bit. You have a a bit more to go on in terms of modeling that.
So what can you share about persistence now that you’ve had a couple of years with the drug on the market? What do we know about that?
Unidentified speaker: Yeah. So we haven’t said too much except when we modeled persistence, the the folks at at Roche Genentech were kind enough to publish a persistence curve on OCREVIS. We
Unidentified speaker: For your benefit, I’m sure.
Unidentified speaker: It was definitely nice of them to do that. Yeah. You know, they love to help us as much as possible. But but we basically use that as our assumption, approximate assumption, and we had we didn’t have really much to go on. What what we have said today is that we believe that what we’re seeing is consistent with, if not slightly better than, what we had anticipated going into it.
Unidentified speaker: Okay. And then in terms of the new patient growth, how do you think about the trajectory of new patient growth? Maybe, like, the rate of change. Is it increasing, stable over time?
Unidentified speaker: Yeah. It’s it’s it’s not linear. Yeah. So you can go I’d say the the we pretty much have grown almost every quarter. Sometimes it’s close to flat.
Sometimes you see a bigger growth rate. So it does depend on on the season. I think that’s probably most of of where we see the differential and sort of the change of growth. But overall, the growth has been I mean, if you flatten it out and turn it into a a trend curve Yeah. We were really pleased with with the continued growth and and capture market share.
Unidentified speaker: Okay. In terms of formulary access and positioning, I guess, what can you share about how Breonb compares to some of these other c d twenty eight therapies across the formularies?
Unidentified speaker: Yeah. So the, you know, the the hope when we launched was that we could at least capture parity Mhmm. Coverage across the board. And and I think the team did an amazing job in getting us parity almost everywhere.
Unidentified speaker: Mhmm.
Unidentified speaker: So I can’t say that we’re parity everywhere, but I will say that it’s if you think of it as as a Venn diagram and coverage and let’s talk about the medical side, not the pharmacy side, which is more of the symptom Yeah. We’re more of the medical benefits. Think about just on the medical benefits side and you think about the the one competitor there. If you did a Venn diagram, you’d put those two circles together. And on the fringes, you would see that there are some plans that prefer us.
Unidentified speaker: Mhmm.
Unidentified speaker: Some plans that prefer OCREVUS, and the vast majority are sitting in the center with with parity coverage.
Unidentified speaker: Okay. So are there is there additional work that you’re work that you’re looking to do in terms of formulary reimbursement access, these kinds of considerations, or do you feel pretty good about where you are at this point?
Unidentified speaker: Feel pretty good. I mean, we’d like to maintain what we have for sure.
Unidentified speaker: What about on the marketing efforts, commercialization, infrastructure? I guess, you made any changes, or are you planning to make any changes around the marketing side? And and when would those be realized to the extent that you’re doing anything?
Unidentified speaker: Yeah. I’ll start with the the latter and go to the former. You know, everything we do, it is hard to know what the if anything is. Mhmm. Right?
Since we don’t have a control group, which I I’d love to have, and I continue
Unidentified speaker: to AB test like they do in tech.
Unidentified speaker: I continue to try to get the team to give me more placebo controlled Yeah. Experiments, but, unfortunately, it doesn’t seem to work out that well. So so it is hard to tell. And so in terms of how much and when these things will have impact, it really is hard to know what’s happening. But what we but but what we have been doing was part of our original plan is when we launched, we launched with a a relatively small field team.
Okay. The idea was to focus on the largest accounts.
Unidentified speaker: Mhmm.
Unidentified speaker: And then from there, expand, you know, the concentric circle model, bull’s eye, and then around and around. And as you grow out, you continue to build. So we’ve more than we’ve just about doubled our field force Okay. During this process. So this that’s worked out.
You know, the one thing we can tell is that in territories where we add new people, the rate of change goes up. Okay. So that that one is easier to you have a before and after. You can see the change. You could also compare that to other territories where there is no change.
Unidentified speaker: Mhmm.
Unidentified speaker: And those seem to do better at least at the outset. So at some period of time, and then they come incorporated. And then Yeah. And so we continue to identify, you know, territories. Again, if you start off small, there leaves some open geographical gaps.
And we identify territories that we think have need, and we’ll add some players there. So that’s worked out great. And then I’d say part two, what I call, you know, air support for our ground forces
Unidentified speaker: Yeah.
Unidentified speaker: Is is marketing. We started out, I’m embarrassed to say, and no one has to know this for sure, but we just started with almost a zero marketing budget Okay. Which, as you can tell, didn’t really hurt us that much. We were we were told you can’t do that. Everyone told me I wasn’t allowed to do that, but we did it anyway.
It worked out fine. But now we’ve expanded into marketing, obviously, and we’ve been doing that for over over two years now. So we’ve been doing it for a while. But we started out online. We we’re continuing to build that presence.
We’ve improved all of our our materials online. If you go to our new website, you can see now we have a number of testimonials and that kind of stuff where you can really start to feel Mhmm. Why individuals are are are gravitating toward Breonvi. Yeah. And we’ve just launched our I call it, TV commercial.
Doesn’t air that much on TV right now, but it’s it’s on connected TV, which I guess most people in this room probably watch besides me. Okay. But but, yeah, I’ve spoke to I was with someone yesterday. I your commercial. So that was nice to hear.
So we’re starting that. So that’s all starting to come together. Okay. Again, PG fashion, start slow. Fig try to figure it out, make sure we’re doing it the right way Okay.
As best as we can given the the Okay. The insurer that I said is hard to figure out.
Unidentified speaker: So incremental changes from here in terms of both the, like, the commercial efforts on the marketing side and the field force, but no major changes planned?
Unidentified speaker: Correct.
Unidentified speaker: Okay. Maybe you could talk a little bit about the patient population on Breomby as it stands today. How should we think about the portion that are kind of coming from a new to class group versus switch patients from other CV twenties?
Unidentified speaker: Yeah. So I typically break it into three groups Okay. If that’s okay.
Unidentified speaker: Yeah.
Unidentified speaker: If I may expand your grouping. So I think about truly naive patients.
Unidentified speaker: Mhmm.
Unidentified speaker: I think about individuals who are switching from another treatment to c d twenty.
Unidentified speaker: Mhmm.
Unidentified speaker: And then, of course, the c d twenty intraclass switches.
Unidentified speaker: Sure.
Unidentified speaker: And what we what we’ve guided, we haven’t given the exact numbers out, but what we’ve said is if you think of, you know, three bars, three bar graph, in the middle, you’ve got this group that is switching from other treatments other than c d twenty. So they’ve been treated, but never with a c d twenty. That is definitely the largest group that’s coming on to Breomvi.
Unidentified speaker: Mhmm.
Unidentified speaker: But it’s not significantly larger. And the other two groups, the naive and the c d twenty switches, are almost the same as each other.
Unidentified speaker: Mhmm. Mhmm.
Unidentified speaker: And not so different than the middle. So the middle is definitely the biggest, but it’s all it’s relatively balanced across the entire spectrum of patients.
Unidentified speaker: Okay. And can you remind us where the current cost share is for c d twenty therapies and how you think this is kind of evolving over the intermediate term? Yeah.
Unidentified speaker: So, you know, when we launched, it was probably just south of 50%. We think it’s probably somewhere between 5055% today, so it is growing. I think as more and more clinicians gravitate toward high high efficacy
Unidentified speaker: Mhmm.
Unidentified speaker: Therapies up front, that will continue to shift. So I don’t know where it ends, but I think we’ll just continue to see a creep upward in that number.
Unidentified speaker: Yeah. You mentioned that the new to class share is, like, here maybe a little less than the or sorry. The the population that’s coming into class that’s getting on to BRIONVY has gotten to, like, this level. Has that changed over time as people get more experience? Or are you basically are you seeing more patients who are getting the CD 20 for the time going to BRIONVY?
Unidentified speaker: It’s somewhat remarkable that the distribution of those three groups
Unidentified speaker: Has been similar.
Unidentified speaker: Has been pretty constant the entire time.
Unidentified speaker: Okay. In terms of just, like, the annual opportunity for switches, how often are people moving between drugs, let’s say, MS broadly and then also within the c d twenty class?
Unidentified speaker: Yeah. So I I don’t have the exact figures, but we assume that it’s about there’s there’s about 80,000 individuals looking for a new treatment every year. We believe about twenty thousand are naive. That means about 60,000 are switches. I think there’s about 300,000 plus treated patients.
Unidentified speaker: Mhmm.
Unidentified speaker: So that’d be about 1 of them every year Okay. Are looking. So one once in every five years are looking to switch, give or take. I mean
Unidentified speaker: Yeah. Sure.
Unidentified speaker: Rough numbers.
Unidentified speaker: Sure. Maybe you can talk a little bit about the kind of the the depth and the breadth that you’ve shared. How many so is it I don’t know how you wanna define this, but, like, how many different accounts have you guys had prescriptions from? What’s the depth of those accounts? Maybe give us the the key parameters that you think about as you look at both of those questions, depth and breadth.
Unidentified speaker: Yeah. So the last time we haven’t given that number out in quite a while in terms of exact numbers. But last time we put it, I think we had over a thousand prescribers at over 500 centers
Unidentified speaker: Okay.
Unidentified speaker: And about 5,000 prescriptions or something that effect. I can’t remember. But we we also I mean, we never announced it, but at conferences, we now have placards, you know, that say over 10,000 prescribed, and that’s growing. And Mhmm. I think we’ll be able to update that in the next few months.
So Mhmm. Prescriptions are growing. Clinicians are growing well beyond what we’ve last reported. I I don’t even actually have the exact number, but I I know that it is has grown quite substantially. So and even if we say I think we said, originally, there were about 550 target centers.
Mhmm. And so the last time we reported about a year ago, let’s say, we had we’re at 500. We’re we’re well beyond that now. Sure. Now remember, there’s 550 we had targeted, but there’s a lot of other centers that as we’ve grown that we’ve we’ve we’ve been in contact with.
So I think we we probably have at least a prescription from almost every target center when we started Yeah. Plus from from others. But in terms of so that’s I’d say there’s there’s a there’s multiple levels of breadth.
Unidentified speaker: Mhmm.
Unidentified speaker: Right? So breadth can be centers. And then but within those centers, there’s usually multiple doctors. Right? So that is that secondary breadth.
And then there’s depth of each I consider each individual doctor. It’s like the depth of them. So how frequently are they
Unidentified speaker: Mhmm.
Unidentified speaker: Prescribing. So while we’ve probably, I think, got our foot in the door Mhmm. In most centers that we we we were targeting
Unidentified speaker: Mhmm.
Unidentified speaker: There’s still more to go that we weren’t originally targeting. But but within those centers, I think there’s a lot more breadth to go. So if you look at, you know, major academic centers where you have anywhere from potentially 10 to 30 prescribers Mhmm. You know, we may have two or three at a major center. Mhmm.
But that leaves us a lot more to go. So there there’s plenty of breadth still left. Okay. And then, of course, we continue to push depth in in everyone. You know?
Again, we have this saying. It’s, you know, get someone to try it. We turn them into what we call a dabbler, and then we want a dabbler to turn into
Unidentified speaker: Mhmm.
Unidentified speaker: A committed user. So we’ve got a lot of depth left to go as well.
Unidentified speaker: Okay. As you think about, like, those physicians that maybe aren’t yet dabblers even, what have you found, like, works in terms of promotion, getting them to understand the product, or what are the gaps that you need to close to get them to try Breon Bay?
Unidentified speaker: Well, some folks I mean, I’ve we’ve tried everything.
Unidentified speaker: Yeah. They’re just
Unidentified speaker: And they’re just just they’re they’re good in their ways. Mhmm. But I think most people I mean, I’ll I’ll give you an anecdote. The the KOL that we spoke to about Breonvi, when we were starting the phase two, came to the office. We were we were really just trying to learn more about MS and show them what we were doing with the phase two.
And and and this gentleman left and said, yeah. I don’t even know why you guys are doing this.
Unidentified speaker: Mhmm.
Unidentified speaker: I bumped into him at a conference recently, and and he said that Brioami is now his number one
Unidentified speaker: Okay.
Unidentified speaker: CD 20. For him, there’s a few attributes that he really likes about it. So, you know, I can’t say that even the the hardest folks are are never gonna come around. I think some of that is time. But but most of it is just, you know, being in front of them, making sure they see the data, make sure they hear about you know, there’s a few things that can get people, you know, off the fence.
Some is, you know, there’s something, you know, affectionately referred to as crap gap. It’s kind of a wearing off effect with some of the drugs. We presented some really interesting data showing that individuals who go in with come off of another c d twenty experiencing crap gap, the vast, vast majority of them do not reexperience it. Umbreumvi, That data was just presented at we’re at CMSC. Okay.
And we had a published paper recently, which is really interesting where we show it’s like seven case studies, but there’s at least two of them where individuals were on Ocrevus. They were not even depleting their B cells. Mhmm. Switch them to Breonv, day one, zeroed out. So, again, you start to see some of these, and then just takes a moment for people to really understand that while they’re targeting B cells
Unidentified speaker: Mhmm.
Unidentified speaker: And c d 20 on the B cells, the way these drugs work is not the same. Okay. There’s a lot of different attributes. There was a paper that was published that goes through all these attributes. Doctor Greenberg, doctor Crave, and doctor Berger are the the authors of this paper.
If anyone wants to really get a good understanding of of B cell biology and the differences in these molecules and why you may see different tolerability and where you may see different efficacy Mhmm. You gotta read this paper.
Unidentified speaker: Okay.
Unidentified speaker: That’s my pitch for that paper.
Unidentified speaker: Definitely to us later.
Unidentified speaker: Yeah. Yeah. For sure. I think it’s on our website probably.
Unidentified speaker: Okay. What about taking a dabbler to kind of a committed prescriber? How long does that process usually take, and what are the things that, like, will push people into the next category?
Unidentified speaker: Yeah. So the the dabblers, I think, is more of a habit issue.
Unidentified speaker: Yeah.
Unidentified speaker: Right? It’s just you fall back into your your your habit, and the habit has always been to okra risk. Sure. Okra risk has has been the habit. So a lot of that is just honestly just being there.
Okay. Just reminding them that Brambee is there. So they’ll use it once or twice, And they also you know, it takes six months for them to see
Unidentified speaker: The patient again.
Unidentified speaker: The patient again and what happened and how was the experience. Yeah. And so there is a long lead time to convert those dabblers. But I think we’ve been been having good success with those folks.
Unidentified speaker: Okay. You are working on a few more kind of convenient dose strategies. There’s a thirty minute infusion. There’s a subcutaneous. You’re talking about consolidating that dose, particularly for switches.
So maybe you can talk about, like, the development timelines for let’s start with the thirty minute, and we’ll do each in turn.
Unidentified speaker: Can I ask a favor?
Unidentified speaker: We which one do you wanna start with?
Unidentified speaker: Can we start with the consolidation of those moments your
Unidentified speaker: way. Yeah.
Unidentified speaker: Because that’s the one I I know the most about
Unidentified speaker: Okay.
Unidentified speaker: In terms of timeline. So that one so so what we’re doing is we’re taking day one and day 15, and we’re gonna do it all as one dose on day one. So that will avoid individuals having to come back. The timeline there, we we should have patients enrolled, you know, probably before the end of this month.
Unidentified speaker: Mhmm.
Unidentified speaker: We think that’s probably only about a six to nine month enrollment period. The endpoint, I think, is it’s a PK endpoint, twelve weeks or something. So pretty short study.
Unidentified speaker: Yeah.
Unidentified speaker: You know, we could have data by middle of next year filing. So we we think that one, excuse me, that one could lead to a label update in sort of the mid twenty seven time frame. So that would be the fastest. Okay. The thirty minute infusion, we’re still having conversations with the agency about what that study needs to look like.
Okay. It’s definitely a little more complicated than the consolidating the dose, so we went for the easy 1 so we can get that one going. So I I put the thirty minutes probably six to nine months behind
Unidentified speaker: Okay.
Unidentified speaker: That one. But, again, don’t hold me to it because we haven’t had
Unidentified speaker: the Still working on details.
Unidentified speaker: Still working on the details. And then subcubrium v, something that the team has been extremely excited about. Feel like there’s room to participate in a part of the market that we have not had access to yet. So you may have heard me say and some other folks said, I mean, the the sub q market is is quite distinct
Unidentified speaker: Mhmm.
Unidentified speaker: In a lot of ways from the IV market. And so while we’ve done a really nice job competing in the IV market, we don’t have a player in the sub q market. And so right now, there’s really just one true subcu that’s given as an, you know, at home, self administered, auto injector, sort of a very clean, easy to use product. That’s the area that we wanna compete. So our product profile will, as best as possible, compete in that marketplace.
Unidentified speaker: Okay. Since they’re distinct, let’s look at the thirty minute of consolidated dose, and then we’ll do the sub q. But on the thirty minute of the consolidated dose, maybe which one do you think will be more meaningful as it comes to, like, bringing more patients into the fold?
Unidentified speaker: Yeah. You know, we’ve done a bit of research on that. I’ve been involved in numerous KOL discussions.
Unidentified speaker: Mhmm.
Unidentified speaker: And they seem pretty pretty equivalent. It’s hard to some people seem to really resonate toward, yeah, it’d be great that they don’t have to come back at week. It also makes scheduling easier when you have to do two schedules Mhmm. Two infusions at once. Matching it up is hard.
People who travel don’t wanna come back. So that one seems to write well with a certain group of clinicians. And then the thirty minute also resonate with a with a lot of folks. You know, it could really get to with a thirty minute infusion, you can get to the point where people can come at lunch hour. They really you know, no one even knows that Mhmm.
Needs to know they’re even leaving to do anything. So I’d say it’s about fifty fifty in terms of which ones were sort of deemed more important from folks we talk to.
Unidentified speaker: Okay. In terms of in particular or as you think about kind of, like, the trade offs is going to these other dosing schedules, I imagine a lot of it is just infusion site reaction or infusion related reactions. Like, what are you willing to tolerate from a tolerability perspective to get to these conveniences?
Unidentified speaker: Yeah. So I think, you know, assuming that we’re we we do better than the label Yeah. Which seems you know, it’s interesting. When when we did the the phase three program, we specifically omitted acetaminophen from the dose because we were measuring B cells on day two, and sometimes you see liver enzyme disruptions from taking that Tylenol the day before. So we we avoided that.
Since we’ve been using Tylenol and all the real world experience, we’ve seen almost almost half of the IRRs that we’ve seen previously. So, again, I think if we’re we’re keeping, you know, in a in a in a zone that looks like what we’re seeing, And we have we’ll have control arms. So we’ll get to see the see it versus each other. And, again, it’ll also be you know, at that point, if it does get labeled, it’ll be clinician and patient preference. So you wanna, you know, take a little more potential IRR risk to the convenience of of one of these two regimens.
Unidentified speaker: Patients will just have options.
Unidentified speaker: Yeah. Options are good.
Unidentified speaker: Okay. In terms of the subcutaneous product, speaking of options, guess as you talk about the target product profile, should we think about this as being more like a Kasimpta, more like Ocrevus de novo, and why? Or is that what you’re going for?
Unidentified speaker: Yeah. So, you know, we don’t currently view de novo as a as part of the SUBQ marketplace. K. We think it’s more likely to be viewed and should be viewed as part of the IV workplace. It’s it’s in the office.
It takes, you know, anywhere from 10 if you use a pump to probably closer to 15 you’re trying to do it by hand, which I think is relatively rare. But it’s an in office product today. I know they’re working on ways to improve that and get it to be an at home product. And at that point, we might we might, in our models, move it over to the subcu. But but currently, Kesimpta really does have a a monopoly on this true subcu
Unidentified speaker: Mhmm.
Unidentified speaker: At home marketplace. So our target product profile is is similar to theirs. It’s a auto injector. You know, it should take, you know, whatever, seconds, not minutes Mhmm. To deliver.
It should be well tolerated. All these are the target product profile.
Unidentified speaker: Okay.
Unidentified speaker: But, yeah, I think and then the the last component is is how long how how frequent you need to take it. Mhmm. We’re looking at probably in the phase three. We haven’t committed to this, but probably gonna look at two dosing regimens. So one would be a q two months, and one would be a q three month.
So quarterly versus every other month. Okay. And Kesimpta currently is delivered as a every month product. Okay.
Unidentified speaker: When can we expect to see, like, bioequivalence type data and some of these, like, more specific clinical results for this product?
Unidentified speaker: Yeah. So probably you know, it could be later this year, but more likely sometime next year.
Unidentified speaker: Okay. And when we do see that, what should we be looking for?
Unidentified speaker: I mean, we’re not we’re not cutting it close, so I think you’ll see bioavailability data. It’s I mean, it’s a PK bioavailability study. You know, you’re gonna see relatively traditional bioavailability information for an antibody that goes from IV to sub q. And like I said, by doing a q two, q three, we’re not taking any chances of of of of of missing. The the goal is for these trials is to be noninferior in terms of AUC.
So what we saw when Ocrevus did their trial, they were even above I mean, if you think of, like, the biosimilar margins, you know, down point eight, up 1.25, This is the only care to the at home self administered auto injector. Yeah. And so and those people, you know, when an individual comes into the to the office and they’re talked when they and the clinician decides that c d twenty is right for them, one of the questions they ask them is, would you like to self inject, or would you like to come in and get an IV infusion?
Unidentified speaker: Yeah.
Unidentified speaker: And so, you know, right now, if someone says, I want to self inject at home Yeah. We’re not competing. That’s a pretty good 40% of the market. So we’ve got room to to capture market share there.
Unidentified speaker: Okay. So do you expect that subcutaneous portion of the market to be stable with the addition of a new option like Briohnvi? Would you expect it to grow? And maybe you can, like, layer into that question. What’s been happening in terms of the overall share SubQ at home is getting?
Unidentified speaker: Yeah. So SubQ has definitely been growing. Mhmm. I think what we’ve what we’ve seen is in the major academic centers. Mhmm.
The SubQ has continued to to grow at a at a reasonable pace. I mean, I think when we started getting involved and as we launched, I think it was close to thirty, thirty five range, in that range. So now it’s closer to 35 to 40% range. So it is definitely growing. What we see is in the major academic centers, there’s a, what they call, a site of care issue.
Right? So the insurers don’t want the major hospitals to be infusing because of what it what they charge for an infusion. Mhmm. So it is, in a lot of ways, just easier for these clinicians just to send folks home with Okay. With the auto injector.
So we think that that trend will continue. I don’t think it’s grown, you know, at a increasing rate, but I think it will continue to to grow over time.
Unidentified speaker: Maybe you can help us just understand the current state of play in Europe, and what is your expectation for where that region’s going?
Unidentified speaker: Yeah. So we did outlicense that to our partners at Nurex Farm. I don’t have all the sort of freshest of information there. We get reports from them on a quarterly basis. But, you know, I I I would expect the market there is continuing to grow similar to the way it is here.
I think there’s a lot of room for for c d twenties to continue to to grow in Europe.
Unidentified speaker: Does the scope of that agreement include a subcutaneous, and is there differences in the way subcu is utilized in Europe versus here in The US?
Unidentified speaker: So they they definitely have rights to acquire the the SubQ. Okay. It’s part of the deal.
Unidentified speaker: Okay. I think SubQ in Europe sometimes does there’s the differences in the way they approach the SubQ versus IV decision. So is there a difference right now in Europe, and would you expect there to be one? You don’t know? K.
I think generally they like them better because doctors don’t make as much. Okay. In terms of the, like, capital allocation, you’ve switched to profitability. Right? So no need for new cash.
But how are you thinking about spending it now that you have a balance sheet that’s growing?
Unidentified speaker: Yeah. So, you know, we continue to, you know, take the the cash flow that comes in and obviously reinvest it in the marketing Yeah. And these new enhancement programs. So a lot of it is is going toward just improving the Bereumvy experience. Yeah.
We’re also looking at investing in potentially other areas for Breon V. We’ve we’ve talked a little bit about, and we haven’t committed to, but we talked a little about potentially MG Mhmm. As a potential expansion for Breon V. So, again, there’s there’s those areas that we’re sort of dipping our toe into and making investments there. Obviously, we’re investing in our CAR T.
Mhmm. And then beyond that, we’ve already started a buyback program. Mhmm. So we’re pretty consistent in the market buying back shares on a relatively regular basis. And then beyond that, we’re we are always and we’ve said this, I mean, it’s been part of our our preamble since the day we started the company.
Mhmm. We’re always looking for new product opportunities that we think will would add value to what we’re doing and we could build with our team.
Unidentified speaker: As you think about those new product opportunities, what do you think are, like, the core competencies of TG that you would like that would inform the assets you’re looking at?
Unidentified speaker: Yeah. So, I mean, both from a clinical side and a commercial side, obviously, MS is something that we’re we’re quite strong in, so we’ll continue there. But I think that that does give us some latitude to some more of the neurological conditions we’re in. We’re in these very large general neurology practices. So I think if we were gonna sort of shift ourselves and grow sort of NMO, MG Mhmm.
CID CIDP in that kind of direction is probably a better fit for us than the other side is to me more into the rheumatological conditions.
Unidentified speaker: Mhmm.
Unidentified speaker: Couldn’t rule those out, and maybe there’s some acquisition or partnership stuff that could help us get there Mhmm. And build into that direction. But in terms of core comments, let’s say MS and and over to the similar neuro side.
Unidentified speaker: Okay. And in terms of I mean, the CAR T is quite early, but you have a commercial business as well. So in terms of stage of development, any priorities there?
Unidentified speaker: Yeah. We’ve got a very long opportunity with Breomby. I I wouldn’t want to we’re not really looking for anything commercial. I mean, if something came up commercial or late stage that we fell in love with Mhmm. We do that.
But I think pipeline building would be more interesting Sure. Given that we have just so much more to do on Breonvi and so much more. I mean, as you know, we’ve said this publicly. Our goal is to be the number one Mhmm. In dynamic share for CD twenties.
We still got plenty of room to go to get there, so we’ve got a lot of work ahead of us. So I wouldn’t want to really disrupt unless it was something that was so easy to just sort of tuck into what we were doing.
Unidentified speaker: Okay. Sounds good. I think that brings us pretty close to time. I really appreciate the conversation today. Thank you.
Thanks, everyone, for joining us.
Unidentified speaker: Thank you. Thank you. Appreciate it.
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