To 2025 Jefferies Global Healthcare Conference after lunch break. It is my pleasure to have the fireside chat with our next presenting company, TG Therapeutics, CEO, Mike Weiss.
Thanks, Roger. Great to see you.
Excellent. All right. Another year. I think the TG story is getting better and better every year, and then every quarter. I think, you know, given the focus almost now is exclusively the CD20 MS story. Obviously, you have another pipeline. We're gonna touch that later on, but that's a key focus for most of the investor and the TG as well. Can we just take a step back just to reflect how this CD20 MS market is becoming now, and then how this will evolve in the future, considering we have a couple moving pieces in terms of, you know, IV versus inject, you know, the IV versus subQ, and then maybe some of the, you have a new regimen coming and maybe some of the other MOA, upcoming.
Yeah, sure. Yeah. So, the CD20 market right now, in terms of, I guess, dynamic and overall market share, is the leading treatment for MS patients. Dynamic market share continues to creep up. You know, we feel like we're gonna continue to see that in terms of all the CD20s will benefit from any shifts as we move forward. I think that's probably just a function of, as more and more newly trained MS clinicians get into the field, they're definitely more likely to treat with an attempt to give the highest efficacy early, right? That's most of them, I'd say most, if not close to all the major KOLs feel that way. There's still a contingent of folks out there, established neurologists, general neurologists, who aren't using CD20s yet, right? That's still gonna expand.
Again, as these younger generations are being trained and growing into the field, you're gonna see a bigger portion of patients go on to CD20s. I think CD20s are in a great position as a whole. In terms of just the IV to subQ distinction, you know, right now there are, well, there are two subQs available, but one is what we would call a true subQ product, something that an individual can take at home. It's an auto injector, and, you know, it's what one would expect of a subQ product in, you know, the year 2025 and beyond, right? That one is there, and they are capturing all of the true subQ business, right? They currently have a monopoly in that area.
I would say that they've grown well into that spot. SubQ is growing and has grown, I don't, you know, maybe slowing now, but it's grown and it's about 35%-40% of all new starts. I think that's a function of, one, you know, academic centers and insurance companies forcing site of care and away from the IV centers at these major academic centers, which are extremely expensive. You know, when they give infusions in the community centers, they're very efficient at what they do. In the hospitals, they're very inefficient and they charge, I wouldn't say they're inefficient, they just charge.
Yeah.
They might be efficient, but they just charge incredible sums. In many cases, they charge more for the actual infusion than the drug cost. That's been an issue.
In a lot of academic centers, you'll see them moving toward the subQ, self-administered at-home product. And then, you know, I think the folks who have developed and marketed that drug have done a pretty good job of engaging with neurologists who don't use CD20s, who are willing to write prescriptions for that. So I think there's a nice market. I think it's gonna continue to grow. But I think, you know, overall, the IV will maintain its position as the leading mode of delivery of CD20s. But, you know, we'll see. I think either way, as you'll, I'm sure we'll get to, TG is hedged or should be hedged. I can't promise it, but we should be hedged.
Yeah. Yeah. We're definitely gonna talk about beyond the, TG's product, in a moment. Maybe just to, you know, wrap up the, the whole market dynamic. What's your expectation for the future CD20 MS, this class for MS? Because some of the investors worry about this class is shrinking, which I don't believe so. We did some, you know, sales analysis. It seems to continue to grow, but in terms of patient number, right? So how we think about in the future, you think that, as you mentioned, maybe young doctor coming to practice, they were more comfortable using CD20 as a B-cell depletion, therapy.
How you think about the overall CD20 and then how you think the split between the IV and the subQ, because you mentioned, like, you think the IV is still gonna be leading, segment, but, you know, just gimme some numbers and then I, we can be satisfied.
Some numbers.
Yeah.
Like I said, I don't know that I have numbers other than right now it's about 65/35, maybe 60/40 at, you know, again, depends on, it's hard to get the exact numbers, but, split. Again, I think there's probably some continued growth on the subQ side, but again, I think IV will maintain its position. I think overall it's a great, the IV is a great product profile. You don't have to worry about compliance. You get to see the patient, they get eyes on. I was just at CMSC talking about these various issues. Again, some people are really, you know, so committed to the IV. Again, they want to make sure the patient gets the drug. They want to see the patient.
They want the, whatever it was, eyes on, eyes on the patient, right? Some people, they give them the subQ and they never see 'em again. That concerns 'em 'cause they don't know what's happening, if they're being compliant, if they're having problems. If they have a major problem, I'm sure they'll show up. If they're having issues that are not fully, you know, manifesting in clinical symptoms, they could be having issues that they're not aware of. I think there's always gonna be a very strong pull toward the IV side. Like I said, there's plenty of forces that are working toward this subQ.
I think the overall CD20 market right now, I believe it's around like 55% of the new, the entire kind of MS patient, using CD20. Do you think this trend is gonna continue into the patient numbers continue to grow?
Yeah. I mean, look, we think it's somewhere between 50% and 55% dynamic market share. So that's a new start, for CD20. I think it's still less on an overall basis. Again, that's just over time that over time the overall market share will catch up to the dynamic market share. It does take years for that to occur. For the moment, yeah, we think, you know, dynamic share, new starts, about 50%-55%, will go on to CD20. And that's, you know, that's up from when we started, which was very close to 50% or upward. We're approaching 50%. So it's creeping up. You know, again, I don't see it going down.
I don't see any factors on the horizon in terms of need for high efficacy treatments, convenience, and scope of how CD20s operate, that there's nothing on the horizon that would usurp that position. Like I said, as more and more newly trained clinicians come into the marketplace and they're all trained on high efficacy first, you know, the choices are limited. I mean, like, TYSABRI still is a great option, but other than that, it's CD20s, right? You know, it's a doctor-patient decision, but I continue to believe that the CD20 class will grow in dynamic share.
Any other mechanism outside of CD20 you think potentially can change the dynamic market share for CD20? Like, you know, we see BCK data, but, you know, seems that no longer be a, used to be an overhang, but seems no longer that scary. Any other mechanism, you know, you keep eye on?
I mean, not that is, not that's near term. I mean, no.
Yeah. Okay. Good. All right. Let's focus on BRIUMVI, right? Because we, overall market is important because BRIUMVI is one of three players right now, right? That's why this market is important. For BRIUMVI, sales is continuing to be outperforming people's expectation. Honestly, when you launch the drug, a lot of the skepticism there, which is, you know, rightfully because, you know, it's very not easy to, for a smaller company to compete with two major pharmas out there, which is you are very successfully capturing the dynamic market share. You also made a very bold statement that you're gonna, you wanna be the number one dynamic market share within the CD20 market. Maybe just what are the key drivers so far having a pretty good, you know, sales trajectory?
We're gonna eventually give you the potential to become the number one in the future.
Sure. Yeah. So, yeah, I mean, look, everyone's gonna have goals, right? I mean, we want to be number one. We didn't get into this market to be number three, right? We're starting out at number three, but we got into being number one. You know, what is it gonna take to get us there? I think we have all the elements. I think time is really the last piece of it, right? I always go back to the three P's and then I'll add the fourth P, which is product, process, people, and I'm gonna add price also, right? We're priced as the lowest, lowest CD20, lowest branded, actually, treatment for MS. In terms of product, we believe we have the best product, right? I'm sure others might argue differently.
I don't know how they could, but they could try. We feel very confident that we've got, you know, a product that's at least as good and we believe provides attributes that make it best in class. We brought in the best people, right? If you wanna market a drug, you need the right people. Adam, Jane and team did a fantastic job in hiring people with, I think the average experience in MS was 12 years. You know, unbelievable, unbelievable group of folks. You mix that with the right process, right? Our marketing strategy, you know, I helped create it. I think it was brilliant. I think the team has executed it brilliantly.
It is how you show up, it is how you operate, you know, in a competitive market, having the best product at the best price does not always win the business. If you have the best people and they show up in the right way, you have your chance of doing that. We put all the four pieces together. We think it is just time now before we are number one.
Okay. Also the time in which we take some patience to get there. You didn't say next year you're gonna get a number one.
I did not.
Yeah. You did not.
That's possible. I did not say that though.
That's another ambitious goal, stretch goal.
Stretch goal. Yes. No, stretch goal category.
We, you know, those four P's are absolutely, you know, very classical kind of a to do the go-to-market strategy. So anything you wanna do differently or further enhancement to be able to get there or something just, you know, take time to continue to execute, you know, in terms of your sales, the size of the team. And then you, you recently say you may do some DTC or the digital. So anything like that, you will be able to achieve the goal.
Yeah. All of those are part of the plan, right? When we set up the plan, it was, you know, target the most impactful clinicians first and then concentric circles widening wider and wider. To do that, you need to add people when you do that, right? We always had this vision of starting with a small team that was focused on a certain group of clinicians, expanding the target list, expanding the group of people, expanding the target list, expanding the group of people. We've done that. I think we probably doubled our commercial team since launch in a very strategic way. We've identified the territories, the centers and people that we needed to be able to have connectivity with. That's been working great and we'll continue to do so, right?
I think we're getting close to a point where we're, I think we have the full team, but I think there's probably more because again, as we get into the subQ, that'll expand to another layer of potential neurologists. I think we're nearing the completion for the IV team build, although I think there's probably a little more to go.
Yeah.
I'm gonna push for more actually.
Yeah.
We'll see what the team says. Anyway, I think we're in great shape there. Yeah, one of the, you know, the team, if you look at the awareness of BRIUMVI in the patient community, it's good, but not great, right? It's probably in the mid 30% range, give or take.
Whereas, I would, I would assume that KESIMPTA and OCREVUS are gonna be, you know, 70% +, right? Despite that, we've done an amazing job because the clinicians believe in the attributes of BRIUMVI and believe that it can help their patients. What we do hear not infrequently is that individuals will come in, they'll have heard of one of the other drugs through DTC marketing.
Yeah.
And the clinicians have asked us, they've asked us, they've said, look, it would, it would help to have better awareness. That's a big goal for us, to improve that awareness and grow it. Again, I think testament to the team and the work that they've done in engaging with clinicians, despite the fact that it's the least well-known of the products, we've done an amazing job in capturing market share.
I think only good things can come from the DTC campaign. I mean, we've started, we've been doing for the last six or nine months online DTC. We've just updated and expanded all of our materials. And obviously we've just recently launched our first full scale, I'll call it a TV commercial.
Yeah.
Most of it is probably online anyway, but we're doing some, I don't know, I call it TV, whatever anyone calls it these days. No one watches it but me apparently.
Yeah. Yeah. I think you told me, you know, be watch out for, you know, your TV on, you know, Netflix or whatever the program you are targeting that the audience.
Exactly. Everyone let me know when you get hit with a commercial 'cause I assume you guys look up MS stuff. If you don't get hit with a commercial soon, let me know and we'll, we'll try to fix that.
Awesome. Okay. Good. So that's your, based on your current profile, which I agree you have some advantage over the current product, you know, particularly for the IV side, but you are continuing to enhance the profile because you see some data from your enhanced trial to see, okay, if I combine the first, second dose as the initial patient and then even faster, right? Why right now you already went our true one hour infusion better than any other IV. And then you can even accelerate that into 30 minutes. You don't see any issue with that. Tell us about that development timeline and the plan. And then, you know, based on your market research, how much you think this profile can attract more patient helping you to get there for the number one?
Yeah. So I agree. Those, those we're not, we're not sitting still. We obviously, we're doing everything as you said on the sales and marketing side, but the development and innovation continues and really with the goal of just making sure we can make the patient experience as good as possible. That is kind of the goal. I mean, no one, no one ever wants to be treated for a condition like MS, but if you can just make it easier or better, why not try? Yes. We're continuing to, we believe, improve upon the already quite easy to use BRIUMVI, which is, you know, right now you come in on day one, you get a four-hour infusion, you come back two weeks later for your one-hour infusion, and it's one-hour infusions basically approximately every six months thereafter. Pretty straightforward.
You know, we think, as you said, you know, no other, no other IV infusion can be given like that. We do, we do hear from folks that, you know, coming back two weeks later is not the most convenient thing to do. I mean, it is common. RITUXAN is dosed that way. OCREVUS is dosed that way. You know, so it's not uncommon, but it's also not necessarily needed. So we've combined the doses. We're gonna run that pivotal trial. We think that study gets up and running in the next month or two. Should be relatively short enrollment, call it six to nine months of enrollment. It's a short end point, probably get to the end point by middle of next year, give or take. Don't hold me to that exactly, but give or take middle of next year for that end point.
Then a filing, I mean, we think we can, you know, if it goes well and FDA does approve it, we think it could be in the label by the second half of 2027. That would be a nice, again, it is, it also is good for the centers. You know, the other thing, you know, scheduling one infusion is hard enough for some of these centers, scheduling at the same time two infusions. Fitting into the matrix on day one and then 15 days later fitting into their matrix for the second infusion does pose some challenges. I mean, people get it done. It's not like the end of the world, but it is a nice convenience for them not to have to do that as well. It is good for the patients, good for the centers. We think that will be a nice addition.
You asked me about market research. Our market research says it's definitely incrementally positive. I can't give you the exact numbers and, you know, market research is market research. I don't think those numbers are exact, but directionally, it appears that convenience of just coming in on day one and not having to come back two weeks later is viewed very positively. The other thing we're working on in terms of the IV experience is we've treated probably close to 100 individuals now with a 30-minute BRIUMVI infusion. That too is something we're working on, what the pivotal trial needs to look like for that. I can't give you a timeline for that one yet. Similarly, again, 30s apparently better than 60. Pretty straightforward, right?
If you can do it in 30 minutes, you know, we hear a lot of folks saying, you know, look, if, if I could do it in 30 minutes, I could do it at lunch hour. No one even needs to know that I even get the infusion if I do it in 30 minutes. Again, market research said incrementally positive, directionally, the right direction for increasing sales and interest. I just personally, you know, if we can make it better, whether it changes the market share or not, which I think it will, but if it does not, it just makes the experience better. I think giving patients the option, again, no one has to do it in 30 minutes. They could do it now. No one has to do it all in one day if they want to do it in two days.
You know, people have a variety of reasons why they may wanna do one or the other. I think patient choice, making it as easy as we can and letting them choose is important, which brings me to an extremely important next product, which is the subQ.
Yeah.
Right. It's all about trying to deliver to the patient what they, what they want, right? Not everyone wants a subQ, not even the majority of people do, but there is a large minority of folks who do like taking it themselves with an auto injector at home, when it's convenient for them. We think that giving them another option, you know, right now there's a monopoly in the marketplace. There's literally one product that owns the subQ market.
How many times have you guys seen a monopoly work out great for the patient and not as well for the company? Or is it the other way around? Works out great for the company and maybe great for the patient, but maybe not. We think getting in there and providing competition will be critical and key. We think, of course, all the attributes of BRIUMVI that are available in the IV and have gotten a lot of people excited. I mean, it will simplify a lot of conversations for anyone who is a BRIUMVI user and believes in BRIUMVI. If the patient wants subQ, which is a question that's asked to pretty much all patients when they come in the door, they only have one option today.
If you're a, if you're an IV BRIUMVI user and that patient walks in the door, I'd say more likely than not, they're not gonna get anything but BRIUMVI at that point. We'll see how it goes. I do think it will add another product, more competition and more competition. We're trying to do something better, in terms of less frequent dosing and we'll see how that works out.
Excellent. Yeah. I do have a question for subQ because you are moving ahead. Just to wrap up the IV, that's enhanced kind of a regimen. You do not have the detail, the guidance for the timeline for the 30 minutes infusion, but should we assume similar timeframe for, I mean, the structure, the pivotal study, like the combined dose for that, shorter, you know, pivotal program?
Yeah. I mean, the end point will be short.
Yeah.
B ecause it's probably just a single dose trial. But I honestly, I don't have that design and we're still working out the details. I don't wanna commit to too much at this point.
Okay. Good. All right. Let's talk about the subQ because that's one of the potentially even bigger impacts to your portfolio because, you know, as you said, this kind of an enhanced regimen is incremental, but you are creating a new category for yourself for BRIUMVI, right? My understanding is you already have pretty confident you can do every other month's dosing, which is, I mean, half of the dose frequency compared to the current monopoly. Is that true? What's the relatively, the development timeline for that? When are we gonna start to see some data? Because people like to see some data.
What do you mean? They don't trust that I'm seeing the data? Come on, guys.
You give us a good, good example. That's, I got you.
Yeah. I know the team is working to pull together, but they're also actively, you know, working on adding more information and more data. So we're still gathering information as we come down to the wire. We're doing a lot fast, as I'm sure you can imagine. I mean, it's an important, new potential product. So, you know, right now, in terms of when data will be available, it's either, you know, sometime in the second half of the year or sometime in the first half of next year. But in terms of getting the study up and running, you know, again, assuming all goes well, our goal is to get the study up and running in the next two months-ish or so. It's probably about a year for enrollment.
And then, you know, give or take another six months for a, the auto injector bridging component of that filing, hopefully in, you know, first half, middle of 2027, approval middle 2028 kind of thing. I mean, again, super rough estimates. We gotta get the study started. Once we get the study started, then we'll know exactly where we are. But yeah, I mean, and we're still gathering data as we speak and we're learning, you know, bits and pieces as we go. So we're getting close, you know, probably, I think we have a quarterly call that will be give or take around, late July, early August-ish, right? Is that typically when we do that?
Yeah.
I think we'll be in a better position then to have a more fulsome discussion about the plan.
We've talked about the study generally being three arms. We're gonna look at Q2 months and Q3 months. Again, that's where we're sitting today. I don't wanna make any promises that that's gonna be the final design, but we're getting close and everything is sort of, pieces are coming together as we get to the end here to get started. Let me just say, it's the best I could do for the moment. We'll have more information coming up soon. We are excited about the product. We think the profile, as we're seeing it today, looks quite good.
Yeah. I think every time we talk about this topic, it seems the confidence level is a little bit higher because initially you don't even commit what's the dosing frequency you see. Oh, let's see if we can do every other month, right? I think very clear now you're confident about every other month. Now today you say talk about every three months, still not firm guidance, but that's likely the direction you wanna, you wanna go after.
Yeah. Look, I mean, we would love to hit on a quarterly product. We think that it would be just a really nice addition to the armamentarium of the clinicians and it'd be great for patients. You know, there's a lot of variables that are coming together. I'll be cautiously optimistic. No promises yet on the program. Let's see where we are on August. I think we'll have a more fulsome update.
Awesome. All right. Good. I think, last quarter, for some reasons, people start to take a look at your profitability and on the bottom line. You know, you give me some, you probably, you talk with a lot of folks as well. This is not necessarily your near-term focus. Just let us know how your current cash position versus your revenue and your OpEx in terms of the development cost. How do those couple pieces sustain the long-term growth for TG?
Yeah. I mean, over time, my expectation is that, you know, the OpEx goes up incrementally and hopefully the revenues are gapping up, right? I mean, last year, what did we do? $310 million? Is it $310 million last year? And this year we're saying what? $560 million? $560 million, right? That's a pretty good jump up. Our expenses are not jumping up like that. Our expenses went up like 10% or 20%, right?
Yeah.
I think our expenses will go up and it's also just a function of what we decide to do, right? We're gonna have expenses on the subQ that's basically built in. The expenses for all these enhanced programs is built in. We did not talk about it, but it's, you know, our work on azer-cel is built in.
What's not probably built in fully yet is, you know, things we do outside of MS with BRIUMVI, right? So we've talked a little bit about MG. We've only done a little bit there, but I think conceptually we get it. We're getting more comfortable with it. We're looking forward to seeing how the CD19 launches into that space. That'll help us also decide what we may wanna do. We're looking at some other potential indications. I think, but those are not, you know, I guess, look, if we go into a pivotal MG study, that's gonna cost some amount of money, but it's gonna be over two years. It's not gonna also dramatically change the overall OpEx.
And then exploratory studies and a few other indications is also just not gonna, it's gonna, it's gonna add to the OpEx, but it's not gonna change it all that much. Yeah, I mean, I think, and then the wild card is, look, we are always out there looking for potential opportunities. If we see something we like, you know, for the most part, those will rn through R&D, you know, if we acquire a product and then we have to spend money on the product. We've been super cautious about how we've done that. We've acquired one thing in the last bunch of years. So it's, and we didn't, we didn't spend a whole lot on it, but it's moving along. Again, I think OpEx is a variable number, but again, it's not gonna gap up. The revenues will hopefully be continuing to gap up.
Yeah. Yeah. No, I think the near-term focus will continue to be driving the top line. And then obviously you are relatively disciplined on the spend side and just the, you know, try to get more growth in the future, right?
Yeah. Yeah. I mean, to be honest, I haven't yet looked at a bottom line number. It's not on my radar screen. It's not a number that I track. If I don't track it, then we're not working toward it, right? We are working toward top line revenue growth and building the business that we wanna build. Whatever drops to the bottom line and turns out to be profits, great. We're also, you know, I'm pretty sure we're buying shares almost every day. Also, that's part of how we're spending our cash right now. You know, like I said, it is not a metric that I track today and I don't assume it'll be a metric I track for the next several years.
Excellent. Thank you, Mike, with us this morning.
Thanks, Roger. Appreciate it.
Thank you.