We just clicked for having a conversation.
Yeah.
Awesome. Good morning, everyone. Thanks for joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined here today with a team from TG Therapeutics. Maybe I'll let you start with a quick overview on the company, and we can go from there.
Yeah, sure. Thanks. Great to see you. 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 BRIUMVI. We've been on the market now about two and a half years-ish, give or take. Things are going well. I'm not going to say too much because I know I'm sure you're going to ask me a lot of questions.
Don't steal my questions.
I don't want to steal your questions. Things are going well. Beyond that, we have some, I guess, improvement programs to BRIUMVI and enhancements. We just do also have a CAR T, CD19 CAR T in the pipeline.
Perfect. I would love to start with the BRIUMVI launch. You mentioned it's well into the third year. It's gone really well. Guidance of $560 million for the full year. I guess, how do you think about guidance, and where do you kind of get conviction in the numbers you put out? Can you describe kind of what are the puts and takes in terms of achieving that?
Yeah. So there's a matrix that the team puts together. There's probably six variables that they look at. To be fair, there's two that are really driving most of it. You've got new starts, and you've got persistence of 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. Primarily, they're driven by the two, new starts and persistence. In terms of the way, as a company, I think we think about guidance is we feel like the worst thing we could do is miss guidance. We try to do the best we can. We do know, I mean, one thing, the only piece of information, I guess, we do know for sure is how many people that are on are supposed to be coming back.
We have a rate of new patients that are coming in, and hopefully it continues to grow. You try to put those two numbers together, you can get a range, or you can get a target. We sometimes do ranges. We sometimes do a point estimate target. I think the goal is to definitely not miss. I will say that at the time, at the moment that the team gives me the estimates, it really is the point estimate is really the number they have the most conviction in and belief. Hopefully there is very little of a downside tail, perhaps maybe a little more of an upside tail. We have seen that in a few quarters. We have seemed to have beaten sometimes modestly, sometimes a little more than that.
Typically, the center point, I think, for investors to know is that we're not taking risks with the number. We do believe at the time we give it, it is the number that is a number we really believe in.
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 bit more to go on in terms of modeling that. 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?
Yeah. So we haven't said too much, except when we first modeled persistence, the folks at Roche Genentech were kind enough to publish a persistence curve on OCREVUS.
For your benefit, I'm sure.
It was definitely nice of them to do that. They love to help us as much as possible. We basically used that as our assumption, approximate assumption. We did not have really much to go on. What we have said today is that we believe that what we are seeing is consistent with, if not slightly better than what we had anticipated going into it.
Okay. 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?
Yeah. It's not linear. You can go, I'd say we pretty much have grown almost every quarter. Sometimes it's close to flat. Sometimes you see a bigger growth rate. It does depend on the season. I think that's probably most of where we see the differential and sort of the change of growth. Overall, the growth has been, I mean, if you flatten it out and turn it into a trend curve, we were really pleased with the continued growth and capture of market share.
Okay. In terms of formulary access and positioning, I guess, what can you share about how BRIUMVI compares to some of these other CD20 therapies across the formularies?
Yeah. The hope when we launched was that we could at least capture parity coverage across the board. I think the team did an amazing job in getting us parity almost everywhere. I can't say that we're parity everywhere. I will say that if you think of it as a Venn diagram and coverage, and let's talk about the medical side, not the pharmacy side, which is more the KESIMPTA, we're more on the medical benefits. If you think about it just on the medical benefits side and you think about the one competitor there, if you did a Venn diagram, you'd put those two circles together. On the fringes, you would see that there are some plans that prefer us, some plans that prefer OCREVUS, and the vast majority are sitting in the center with parity coverage.
Okay. Is there additional 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?
I feel pretty good. I mean, we'd like to maintain what we have, for sure.
What about on the marketing efforts, commercialization, infrastructure? I guess, have you made any changes, or are you planning to make any changes around the marketing side? When would those be realized to the extent that you're doing anything?
Yeah. I'll start with the latter and go to the former. Everything we do, it is hard to know what the, if anything, is, right? Since we do not have a control group, which I'd love to have, and I continue.
You can't A/B test like they do in tech.
I continue to try to get the team to give me more placebo-controlled experiments, but unfortunately, it does not seem to work out that well. It is hard to tell. In terms of how much and when these things will have impact, it really is hard to know what is happening. What we have been doing, which was part of our original plan, is when we launched, we launched with a relatively small field team. The idea was to focus on the largest accounts and then from there expand the concentric circle model, bullseye, and then around and around. As you grow out, you continue to build. We have just about doubled our field force during this process. That has worked out. The one thing we can tell is that in territories where we add new people, the rate of change goes up.
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, and those seem to do better, at least at the outset, so at some period of time. They become incorporated. We continue to identify territories. Again, if you start off small, there leaves some open geographical gaps. We identify territories that we think have need, and we'll add some players there. That's worked out great. I'd say part two, what I call air support for our ground forces, 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, which, as you can tell, did not really hurt us that much.
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. Now we've expanded into marketing, obviously. We've been doing that for over two years now. We've been doing it for a while. We started out online. We're continuing to build that presence. We've improved all of 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 why individuals are gravitating toward BRIUMVI. We've just launched our first, I call it TV commercial. It doesn't air that much on TV right now, but it's on Connected TV, which I guess most people in this room probably watch besides me. Yeah, I spoke to, I was with someone yesterday.
I was like, "Oh, I saw your commercial." That was nice to hear. We're starting that. That's all starting to come together. Again, TG fashion, start slow, try to figure it out, make sure we're doing it the right way as best as we can, given the insurer that I said is hard to figure out.
Incremental changes from here in terms of both the commercial efforts on the marketing side and the field force, but no major changes planned.
Correct.
Okay. Maybe you could talk a little bit about the patient population on BRIUMVI 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 CD20s?
Yeah. So I typically break it into three groups, if that's okay.
Yeah.
If I may expand your grouping. I think about truly naive patients. I think about individuals who are switching from another treatment to CD20. Of course, the CD20 interclass switches. What we've guided, we haven't given the exact numbers out. What we've said is if you think of three bars, three-bar graph, in the middle you've got this group that is switching from other treatments other than CD20. They've been treated, but never with a CD20. That is definitely the largest group that's coming onto BRIUMVI. It's not significantly larger. The other two groups, the naive and the CD20 switches, are almost the same as each other and not so different than the middle. The middle is definitely the biggest, but it's relatively balanced across the entire spectrum of patients.
Okay. Can you remind us where the current cost share is for CD20 therapies and how you think this is kind of evolving over the intermediate term?
Yeah. When we launched, it was probably just south of 50%. We think it's probably somewhere between 50 and 55% today. It is growing. I think as more and more clinicians gravitate toward high-efficacy therapies upfront, that will continue to shift. I do not know where it ends, but I think we will just continue to see a creep upward in that number.
Yeah. You mentioned that the new-to-class share is here maybe a little less than the, or sorry, the population that's coming that's new-to-class that's getting onto BRIUMVI has gotten to this level. Has that changed over time as people get more experience? Or basically, are you seeing more patients who are getting the CD20 for the first time going to BRIUMVI?
It's somewhat remarkable that the distribution of those three groups.
Has been similar.
Has been pretty constant the entire time.
Interesting. Okay. In terms of just the annual opportunity for switches, how often are people moving between drugs, let's say MS broadly, and then also within the CD20 class?
Yeah. So I do not have the exact figures, but we assume that it is about, there is about 80,000 individuals looking for a new treatment every year. We believe about 20,000 are naive. That means about 60,000 are switches. I think there is about 300,000 plus treated patients. That would be about 1/5 of them every year are looking. Once in every five years are looking to switch, give or take. I mean, rough numbers.
Sure. Maybe you can talk a little bit about kind of the depth and the breadth that you've shared. How many, I don't know how you want to define this, but how many different accounts have you guys had prescriptions from? What's the depth at those accounts? Maybe give us the key parameters that you think about as you look at both of those questions, depth and breadth.
Yeah. The last time, we have not given that number out in quite a while in terms of exact numbers. The last time we reported, I think we had over 1,000 prescribers at over 500 centers and about 5,000 prescriptions or something to that effect. I cannot remember. We also, I mean, we never announced it, but at conferences, we now have placards that say over 10,000 prescribed, and that is growing. I think we will be able to update that in the next few months. Prescriptions are growing. Clinicians are growing well beyond what we last reported. I do not even actually have the exact number, but I know that it has grown quite substantially. Even if we say, I think we said originally there were about 550 target centers. The last time we reported about a year ago, let us say we are at 500.
We're well beyond that now. Now, remember, there's 550 we had targeted, but there's a lot of other centers that, as we've grown, that we've been in contact with. I think we probably have at least a prescription from almost every target center when we started, plus from others. In terms of, so that's, I'd say there's multiple levels of breadth, right? Breadth can be centers, and then, but within those centers, there's usually multiple doctors, right? There's that secondary breadth. Then there's depth of each, I consider each individual doctor, it's like the depth of them. How frequently are they prescribing? While we've probably, I think, got our foot in the door in most centers that we were targeting, there's still more to go that we weren't originally targeting. Within those centers, I think there's a lot more breadth to go.
If you look at major academic centers where you have anywhere from potentially 10-30 prescribers, we may have two or three at a major center, but that leaves us a lot more to go. There is plenty of breadth still left. Of course, we continue to push depth in everyone. Again, we have this saying, it's get someone to try it, you turn them into what we call a dabbler, and then we want a dabbler to turn into a committed user. We have a lot of depth left to go as well.
Okay. As you think about those physicians that maybe aren't yet dabblers even, what have you found 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 BRIUMVI?
Some folks, I mean, we've tried everything.
Yeah. They're just.
They're just, they're good in their ways. I think most people, I mean, I'll give you an anecdote. The first KOL that we spoke to about BRIUMVI, when we were starting the phase II, came to the office. We were really just trying to learn more about MS and show them what we were doing with the phase II. This gentleman left and said, "Yeah, I don't even know why you guys are doing this." I bumped into him at a conference recently, and he said that BRIUMVI is now his number one CD20. For him, there are a few attributes that he really likes about it. I can't say that even the hardest folks are never going to come around. I think some of that is time.
Most of it is just being in front of them, making sure they see the data, make sure they hear about, there's a few things that can get people off the fence. Some is there's something affectionately referred to as crap gap. It's kind of a wearing-off effect with some of the drugs. We've presented some really interesting data showing that individuals who go in with, come off of another CD20 experiencing crap gap, the vast, vast majority of them do not re-experience it on BRIUMVI. That data was just presented at where we're at CMSC. We had a published paper recently, which was 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. Switch them to BRIUMVI, day one, zeroed out.
Again, you start to see some of these, and then it just takes a moment for people to really understand that while they're targeting B cells and CD20 on the B cells, the way these drugs work is not the same. There's a lot of different attributes. There was a paper that was published that goes through all these attributes. Dr. Greenberg, Dr. Craig, and Dr. Berger, the authors of this paper, if anyone wants to really get a good understanding of B cell biology and the differences in these molecules and why you may see different tolerability and why you may see different efficacy, you got to read this paper. That's my pitch for that paper.
You can send it to us later.
Yeah. For sure. I think it's on our website probably.
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 will push people into the next category?
Yeah. So the dabblers, I think it's more of a habit issue. It's just you fall back into your habit, and the habit has always been to OCREVUS. OCREVUS has been the habit. A lot of that is just, honestly, just being there. Just reminding them that BRIUMVI is there. They'll use it once or twice. It also takes six months for them to see.
The patient again.
The patient again and what happened and how was the experience. There is a long lead time to convert those dabblers. I think we've been having good success with those folks.
Okay. You are working on a few more kind of convenient dose strategies. There is a 30-minute infusion. There is the SUB-Qtaneous. You are talking about consolidating that first dose, particularly for switches. Maybe you can talk about the development timelines for, let's start with the 30-minute and we will do each in turn.
Can I ask a favor?
Which one do you want to start with?
Can we start with the consolidation of dose?
Perfect. Let's do it your way. Yeah.
Because that's the one I know the most about in terms of timeline. So that one, what we're doing is we're taking day one and day 15, and we're going to do it all as one dose on day one. That will avoid individuals having to come back. The timeline there, we should have first patients enrolled probably before the end of this month. We think that's probably only about a six to nine-month enrollment period. The endpoint, I think, is it's a PK endpoint, 12 weeks or something. Pretty short study. We could have data by middle of next year filing. We think that one, excuse me, that one could lead to a label update in sort of the mid-2027 timeframe. That would be the fastest. The 30-minute infusion, we're still having conversations with the agency about what that study needs to look like.
It's definitely a little more complicated than consolidating the first dose. So we went for the easy one first so we can get that one going. I put the 30 minutes probably six to nine months behind that one. Again, don't hold me to it because we haven't had the.
Still working on the details.
Still working on the details. SUB-Q BRIUMVI, something that the team has been extremely excited about. I feel like there's room to participate in a part of the market that we have not had access to yet. You may have heard me saying, some other folks said, "I mean, the SUB-Q market is quite distinct in a lot of ways from the IV market." While we've done a really nice job competing in the IV market, we don't have a player in the SUB-Q market. Right now, there's really just one true SUB-Q that's given as an at-home, self-administered, auto injector, sort of a very clean, easy-to-use product. That's the area that we want to compete. Our product profile will, as best as possible, compete in that marketplace.
Since they're distinct, let's look at the 30-minute, the consolidated dose, and then we'll do the SUB-Q. On the 30-minute and the consolidated dose, maybe which one do you think will be more meaningful as it comes to bringing more patients into the fold?
Yeah. We've done a bit of research on that. I've been involved in numerous KOL discussions, and they seem pretty equivalent. It's hard. Some people seem to really resonate toward, "Yeah, it'd be great that they don't have to come back a second week." It also makes scheduling easier. When you have to do two schedules, two infusions at once, matching it up is hard. People who travel don't want to come back. That one seems to write well with a certain group of clinicians. The 30-minute also resonates with a lot of folks. It could really get to, with a 30-minute infusion, you can get to the point where people can come at lunch hour. No one even knows that they need to know they're even leaving to do anything.
I'd say it's about 50/50 in terms of which ones were sort of deemed more important from folks we talked to.
Okay. In terms of, in particular, as you think about kind of the trade-offs of going to these other dosing schedules, I imagine a lot of it is just infusion site reaction or infusion-related reactions. What are you willing to tolerate from a tolerability perspective to get to these conveniences?
Yeah. So I think assuming that we do better than the label, which seems essentially, when we did the phase III program, we specifi`cally omitted acetaminophen from the first 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 avoided that. Since we've been using Tylenol and all the real-world experience, we've seen almost half the IRRs that we had seen previously. So again, I think if we're keeping in a zone that looks like what we're seeing, and we'll have control arms, so we'll get to see versus each other. And again, it'll also be at that point, if it does get labeled, it'll be clinician and patient preference. Are you willing to take a little more potential IRR risk to the convenience of one of these two regimens?
Patients will just have options.
Yeah. Options are good.
Okay. In terms of the subcutaneous product, speaking of options, I guess as you talk about the target product profile, should we think about this as being more like a KESIMPTA, more like OCREVUS ZUNOVO , and why? Is that what you're going for?
Yeah. We do not currently view ZUNOVO as part of the SUB-Q marketplace. We think it is more likely to be viewed and should be viewed as part of the IV workplace. It is in the office. It takes anywhere from 10 if you use a plum to probably closer to 15 if you are trying to do it by hand, which I think is relatively rare. It is an in-office product today. I know they are working on ways to improve that and get it to be an at-home product. At that point, we might, in our models, move it over to the SUB-Q. Currently, KESIMPTA really does have a monopoly on this true SUB-Q at-home marketplace. Our target product profile is similar to theirs. It is an auto injector. It should take, whatever, seconds, not minutes, to deliver. It should be well tolerated.
All these are the target product profile. Yeah, I think, and then the last component is how long, how frequent you need to take it. We're looking at probably in the phase III, we haven't committed to this, but probably going to look at two dosing regimens. One would be a Q2 months and one would be a Q3 months, so quarterly versus every other month. KESIMPTA currently is delivered as an every month product.
Okay. When can we expect to see bioequivalence type data and some of these more specific clinical results for this product?
Yeah. So probably it could be later this year, but more likely sometime next year.
Okay. When we do see that, what should we be looking for?
I mean, we're not cutting it close. I think you'll see bioavailability data. It's a PK bioavailability study. You're going to see relatively traditional bioavailability information for an antibody that goes from IV to SUB-Q. Like I said, by doing a Q2, Q3, we're not taking any chances of missing. The goal for these trials is to be non-inferior in terms of AUC. What we saw when OCREVUS did their trial, they were even above. If you think of the biosimilar margins, down 0.8, up 1.25, this is your only. To the at-home self-administered auto injector.
Those people, when an individual comes into the office and they're talked, and the clinician decides that CD20 is right for them, one of the first questions they ask them is, "Would you like to self-inject or would you like to come in and get an IV infusion?" Right now, if someone says, "I want to self-inject at home," we're not competing. That's a pretty good 40% of the market. We've got room to capture market share there.
Okay. So do you expect that subcutaneous portion of the market to be stable with the addition of a new option like BRIUMVI? Would you expect it to grow? Maybe you can layer into that question, what's been happening in terms of the overall share SUB-Q at home is getting?
Yeah. So SUB-Q has definitely been growing. I think what we've seen is in the major academic centers, the SUB-Q has continued to grow at a reasonable pace. I mean, I think when we started getting involved and as we launched, I think it was closer to 30%-35% range, in that range. So now it's closer to 35%-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. So the insurers don't want the major hospitals to be infusing because of what they charge for an infusion. So it is, in a lot of ways, just easier for these clinicians just to send folks home with the auto injector. So we think that that trend will continue.
I don't think it's grown at an increasing rate, but I think it will continue to grow over time.
Okay. Maybe you can help us just understand the current state of play in Europe and what is your expectation for where that region is going?
Yeah. We did out-license that to our partners at Nuraxp harm. I do not have all the sort of freshest of information there. We get reports from them on a quarterly basis. I would expect the market there is continuing to grow similar to the way it is here. I think there is a lot of room for CD20s to continue to grow in Europe.
Does the scope of that agreement include a subcutaneous? And are there differences in the way SUB-Q is utilized in Europe versus here in the U.S.?
They definitely have rights to acquire the SUB-Q. It's part of the deal.
Okay. I think SUB-Q in Europe sometimes does, there's the differences in the way they approach the SUB-Q versus IV decision. Is there a difference right now in Europe? Would you expect there to be one? You don't know? Okay. I think generally they like them better because doctors don't make as much. In terms of the capital allocation, you've switched to profitability, right? No need for new cash. How are you thinking about spending it now that you have a balance sheet that's growing?
Yeah. We continue to take the cash flow that comes in and obviously reinvest it in the marketing and these new enhancement programs. A lot of it is going toward just improving the BRIUMVI experience. We're also looking at investing in potentially other areas for BRIUMVI. We've talked a little bit about it and we haven't committed to, but we talked a little about potentially MG as a potential expansion for BRIUMVI. Again, there are those areas that we're sort of dipping our toe into and making investments there. Obviously, we're investing in our CAR T. Beyond that, we've already started a buyback program. We're pretty consistent in the market buying back shares on a relatively regular basis. Beyond that, we are always, and we've said this, I mean, it's been part of our preamble since the day we started the company.
We're always looking for new product opportunities that we think would add value to what we're doing and we could build with our team.
As you think about those new product opportunities, what do you think are the core competencies of TG that would inform the assets you're looking at?
Yeah. So I mean, both from a clinical side and a commercial side, obviously, MS is something that we're quite strong in. So we'll continue there. I think that does give us some latitude to some more of the neurological conditions. We're in these very large general neurology practices. I think if we were going to sort of shift ourselves and grow sort of NMO, MG, CIDP, and that kind of direction is probably a better fit for us than the other side is to me more to the rheumatological conditions. Couldn't rule those out. Maybe there's some acquisition or partnership stuff that could help us get there and build into that direction. In terms of core competencies, I'd say MS and over to the neuro side.
Okay. In terms of, I mean, the CAR T is quite early, but you have a commercial business as well. In terms of stage of development, any priorities there?
Yeah. We've got a very long opportunity with BRIUMVI. 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, we'd do that. I think pipeline building would be more interesting given that we have just so much more to do on BRIUMVI and so much more. I mean, as you know, we've said this publicly, our goal is to be the number one in dynamic share for CD20s. We've still got plenty of room to go to get there. We've got a lot of work ahead of us. 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.
Okay. Sounds good. I think that brings us pretty close to time. I really appreciate the conversation today. Thanks, everyone, for joining us.
Thank you. Thank you. Appreciate it.