Good afternoon, everyone. Welcome to 2024 Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analysts covering SMID-cap biotech in the U.S. It's my pleasure to have the fireside chat with our next company, TG Therapeutics CEO, Mike Weiss.
Thanks, Roger. Appreciate the invitation.
Absolutely, every year. Mike, maybe before we talk about your launch, your exciting pipeline, what is your, you know, intro remark for the folks who may not necessarily familiar with TG? Maybe including some of the recent updates from your company, that would be appreciated.
Yeah. So, yeah, TG is kind of a pretty simple company these days. We've got our lead product approved. It's called Briumvi. It's approved for patients with the relapsing forms of multiple sclerosis. We launched the drug basically in the beginning of February of 2023, so we're now into our fifth full quarter of sales, give or take. We've guided that this year we'd do somewhere between $270 million and $290 million in revenues. Yeah, beyond that, our drug is IV. It's given once every six months for one hour. And we're also working on a subcutaneous version of our drug, and we have a CAR T, a CD19 CAR T in clinical trials. Well, soon to be in clinical trials.
But yeah, we're relatively simple, and the revenues are flowing and, you know, we're just chugging along.
Excellent! And I think I know you since for my career, the entire Wall Street career for almost eight years. You know, it's a long journey, but now you're full commercial company now, and then also you have some pipeline, just like you said, some of the cell therapy and some additional indication. Maybe we stay on the commercial product-
Sure.
Briumvi for multiple sclerosis, relapsing remitting form. Now, launch being strong, right? Honestly, it, it's just started, and, you have a couple competitor, also dominating the space, but you are doing pretty well, kind of, for, in the, in the dynamic market share. I get that catch, the terminology there. So what are the key launch metrics you have been tracking, and then why you have the confidence you will become the number one, dynamic market share player in the future?
Yeah. So as you, I think you said, and I completely agree with it, I mean, the launch has gone quite well. Certainly exceeded all of our expectations. In terms of metrics that we're following, it. You know, I think to your point, I mean, it's a relatively competitive space. The nice part, I mean, it's a small group of CD20 companies, so it's us, Roche, and Novartis. So it's a small group. It's about 50% or more of patients starting a new therapy and for multiple sclerosis will go on to a CD20. So there's probably 20 approved drugs, 19, 18, whatever, approved drugs in MS. Those drugs will compete for the other half, and the 3 of us will compete for our half.
And like I said, I, I think our half is growing, so it's, it could be over 50 now, and I think expectations are that it could grow to almost 60% of all patients starting a new therapy will go on to CD20. So that's, that's sort of the, the overall the market. In terms of metrics that we, we like to follow, and I, and I say "we" somewhat loosely, I like to follow within the company.
So I, I do care about new patient start forms that go to our hub. It's really the, the front end of the, of the sales cycle that we can follow. There's a few, few shortcomings of, of that approach. One is there are centers that don't use the hub services, so if they write a prescription, we don't know that they wrote it. So if I tell you we got 100 subscriptions into our hub, that's not all the subscriptions that have occurred during whatever period of time we're referring to.
Yep.
We estimate that there's probably 80%-90% right now of capture of those things. We will talk about it on our quarterly calls.
Yep.
You know, the distribution of the use, like I said, of the hub is less in academic centers and more in the community. So as we bring on more and more academic centers, the capture rate will go down. So what we know to what exists will trend down. But having said that, that's why I follow it. The reason why I say "I" instead of "we" is some folks at the company don't find it to be the perfect answer, but we don't have a better answer for the moment.
We do about six months after the fact, through claims data, we could kind of piece together what happened and what the percentage capture rate is. What I understand is that right now we think it's about 80%-85% capture rate. So whatever... If I tell you we had 100 into the hub, maybe 115-ish were total.
That kind of thing. I also like to look at the centers that are using the drug, the doctors in those centers, right? So you have, there's community practices where there's just a handful of providers, but at some of the academic centers, you could have 20 providers, and if we only have two using it, now I wanna see the growth in the use even within some of those centers. So that's a metric that I like to follow as well. Yeah, yeah. Those are the ones I spend most of my time.
Yeah, I think those are the very indicative kind of metrics, particularly for the hub. I agree, you know, because it's IV drug, so you don't have this prescription right from the pharmacy, so that's the best kind of indicator you can get from the-
Yeah
... from the field. Okay, good. You know, we tracked then, you know, Wall Street, including my team, and also track those metrics. I think, you know, every quarter we're seeing the trending towards the right direction. And honestly, you're now getting the market share is, you know, pretty respectful, right? And then the other thing that you just mentioned, you know, you're competing against Roche and Novartis, which is an honor, right? So you're part of the three horse game here.
Yeah.
But also it's, you know, daunting, right? So they're the big player. Understanding your patient is coming from—you know, mostly coming from three segments. One is as the first CD20 kind of treatment, they prefer TG, and then also from the patient first using MS drug, no other kind of, you say, 20 other drugs for the MS, like new to the treatment for, for you. And then last thing is switching from Roche and the Novartis to you. So maybe just tell us a little about, about what are the key drivers for patient or physician make decision to use TG, from those three segments?
Yeah. So we could probably lump two segments together-
Yep
... right? If you, if you're naive to all treatment or you're switching to a CD20-
Similar, yep.
Basically, you're gonna have the same calculus. And my understanding is from a lot of the clinicians that the first thing they'd want to assess is if once they decide that a CD20 is what they want to use, their first assessment will be: do you want to self-inject or you want to come to an infusion center? Right? For those who want to self-inject, there's one option. Today there's one option.
And so they will get onto that drug. For the ones who choose IV, then, you know, I think the patients that end up on Briumvi are ones who either are excited about the 1-hour infusion, they're excited about the clinical data. The annualized relapse rates are quite low with Briumvi. I'd say those are probably the two most significant things for someone just new. It's, you know, how well does it work? How often do I have to come in, and how long am I gonna have to be there for?
Yep.
So, I think that's, that's where we see Briumvi shine. And then for patients that are switching from another CD20, I'd say, you know, pretty, pretty good distribution across patients who either, again, want a one-hour infusion or, for whatever reason, they're not well-tolerating their other therapy, whether it's Ocrevus or Kesimpta. We do hear with Kesimpta about some needle fatigue. And then for all of them—for both of them, there's some aspect of breakthrough disease characterized as either a wearing off effect or not feeling well or relapsing rather quickly.
For all of those reasons, people will consider moving to another CD20 before they go outside the class. You know, the CD20s are, I think, without question, the most active agents for this disease. So you would prefer to find a CD20 that works before you go to something else outside the class. If you've decided that a CD20 was right for them in the first place, you want to keep them on and give it a shot.
Yeah. And then just to remind us, what's the breakdown between those two big kind of category for the current Briumvi sales?
Yeah. So what we've said, we haven't given the exact breakout, but what we've said in the past is the largest group of patients is gonna be from, I would look at as the center group, which is they've been treated, but they've never been treated with CD20. Then you've got naive to all treatment, and you've got CD20 switches, and they're about equivalent.
Okay.
So they're a little bit lower than the middle group, but across the board, they're not, you know, they're not all that different. I mean, I think you could probably within 10 percentage points of each one, you'd find all of it. So I wouldn't say it's flat, but it's, it's not driven by one particular group. All of them are contributing quite a bit.
Got it. Like a 50, 30, 20 type of the-
Well, 50 and 30, more than 10.
Yeah.
So probably less than that, I think, even.
Got it. Got it. Okay. So 10 is the middle, this naive population.
Give or take. I mean, it could be 12 or 13 or whatever, but-
Yeah
Yeah, it's, they're all pretty close.
Got it. Okay, good. You know, very obvious competitor upcoming or they already kind of are, have some noise in the market is the SubQ Ocrevus, so which is the Roche's drug. They have many different reason why they wanna come up with this, SubQ. As you mentioned earlier, the first decision-making point is if you use SubQ injection or the IV infusion. So tell us a little about your the feedback you have been hearing from the field, about this, SubQ Ocrevus. How will that change the dynamic, for the future, CD20 space?
Yeah. So, I mean, to be fair, for the moment, the SubQ, Ocrevus is not really about self-injecting. Right? It's a healthcare, administered product, whether given in an office or at home. So it's not here nor there yet, for the moment, although I know they do have plans to-
Yeah
... bring it as a self-administered home product. At that point, I think they can, they can get a better answer to that question, if you want to self-inject or you want an, you know, an IV in the office . You know, look, we were at the CMSC conference, we were at AAN before that. We've talked to a lot of clinicians. You know, we're just not seeing a whole lot of interest in that product. I assume versus hearing the same stuff we're hearing. But I do encourage you and investors to chat with them, and they're obviously doing their market research, and they're figuring stuff out, and we're not really doing full market research on their product. But in conversations we've had, just doesn't appear to be the profile that that would be changing the landscape.
Yeah. Yeah, based on my understanding, the administrative or administration profile is not dissimilar, too dissimilar to the IV infusion for Briumvi in terms of the pre, post monitoring, plus this infusion the whole time. If we're talking about just infusion time in the clinic, this kind of, the process.
Yeah, I mean, the delivery of an infused product is a high throughput procedure at this point for many of these facilities. So, you know, a patient walks in, they set up the IV, they drop the bag, and they walk away, and they watch other patients. I think there's- it's a little bit different when you're putting a needle under the skin somewhere, setting up the pump, or if they don't have access to the pump, they're gonna manually push-
Yeah.
...for over a 10- or 15-minute period.
Yeah.
You're gonna create bruising and swelling. You know, it doesn't seem like it's a great natural fit into these centers, although there I imagine there could be some centers that will adjust their procedures. But, and then, you know, so if it takes, you know, 10 minutes once they turn a pump on or 10-15 minutes, they have to push it. I mean, if they have to push it themselves, that means a nurse has to be sitting there the entire time. I think that's pretty much a no-fly zone. I don't, can't be sure, but, I mean, you hang a bag, you go on to the next patient. You can, you know, infuse multiple patients at a time, and monitor. So yeah, I will see how it goes.
Like I said, chat with them about it, but in terms of overall time saving, I'm not sure it's gonna save the site much time. I'm not sure it's gonna save the patient, and we don't know exactly, you know, if they're gonna have an hour of monitoring time afterwards. We do know that with Briumvi, if you go through the first two infusions without issue, by the third, you don't have to hang around for that extra hour. So in terms of total time in the office, I'm not so sure that anyone's gonna save a lot of time, and it's a whole new procedure for them to learn and go through.
Yeah. Yep, got it. And by the way, you are trying to develop the subQ Briumvi version as well. I believe it's coming, you're finalizing the candidate. Maybe tell us, so what is your target product profile for your subQ Briumvi, and then what's the timeline look like for the clinical development?
Yeah. So, you know, our goal for the program is to come up with something that can be delivered via an auto-injector, given less frequently than what's currently available, which is once per month would be the target. Obviously, the least amount of injections per year is the goal, and it's too early to tell where we'll land exactly.
So we, you know, we're, we've got a formulation ready to test in people, and then we need to just, you know, understand what the bioequivalent dose is, and then we'll know how much material we'll need, and then we'll know how frequently we need to dose. So we're we're at the beginning phases. My guess is it'll take us about six to eight months to get that answer. Another few months, and we'll be able to start a pivotal trial. So I think we're targeting starting the pivotal trial about a year from now.
Okay. You will start a bioavailability bridging study pretty soon, and then get to the first kind of answer, and then moving to the pivotal.
Exactly.
Yeah.
Yeah, that study should start imminently.
Yeah.
Like I said, take us about six to eight months to figure it all out.
Yeah. Got it. Okay, good.
Yeah.
I think you recently issued three additional patent for Briumvi, and then, you know, tell us about how what's the strengths of the patent, what what it's cover. And also, because of the patent and then you will potentially explore additional indication beyond the MS for Briumvi. Maybe tell us about what's the consideration to develop additional indication for Briumvi.
Yeah, we were excited to get the new patents issued. We feel they're very strong. There's a new composition of matter patent. The original composition was purely on the protein sequence. The new is on the entire compound, which includes the protein and the glycosylation pattern. So this is the whole molecule composition of matter. And then in addition, we added in, I think, formulation and manufacturing patents, which provide additional walls of protection.
So yeah, we're... I mean, we expect that we'll have exclusivity through 2042. And yes, it does free us up to do more work with the compound, and we are in the process of evaluating other indications outside of MS, you know, ranging from NMO, MG, RA, Lupus. We haven't made a decision yet. Some of it is, you know, just identifying what we think makes the most sense and where the need is in the marketplace, and we're doing a bunch of that work now.
We're also, you know, before we get started, you know, we're determining whether IV or subQ would make the most sense in some of those indications. Obviously, if we think subQ makes the most sense, we're gonna wait a little bit to, to use our subQ. If we think the IV program makes more sense. So we have some pieces of information that come together, both clinically and sort of market research-wise, and then we'll be able to determine where the next steps are.
Excellent. You know, obviously, the launch is going pretty strong in the U.S. You know, the guidance last quarter beat in the race, so we'll see if you can do that again in the 2Q. Everyone look forward to that. And then, you know, with the pattern with your, your partner, so how should we think about the Briumvi long-term commercialization strategy as a, you know, SMID-cap biotech, and everyone's thinking, "Okay, do they need a partner or not?" And what's your current thinking around that?
Honestly, I think at this point, we have probably the most productive commercial team in MS. I don't, there's no other company... I mean, look, I think Roche and Novartis clearly have, have nice teams as well, but, you know, for a lot of reasons, we're not gonna be working with them. And, so when you go outside of those folks, I think, you know, if you, if you did, I think even if you surveyed, including those folks, I think we have done some of these surveys. I think we get top marks with our commercial team.
I think our reach, our depth, our relationships are exceed any other company in MS at this point, or very close to the top. And again, particularly, if you eliminate those two, for sure, I don't think anyone really is close to what we've put together. So partnering, I think, is I mean, if anyone wants to partner, they should call us.
If anyone has any need to partner in MS, they should be giving us a call, not us giving someone else a call. That's for sure. So in terms of long term, look, we've built the team. It's operating extremely well. We're continuing to grow the team, right? We've said, you know, our burn will creep in, and that's basically the way our, you know, and we're slowly building our commercial team from launch. We're only, like I said, five quarters in. You know, I think we've increased our commercial size by 20% over that time, and my guess is it will continue to grow slow and steady as we continue to identify places and people that we might need additional help with. We can bring on people to help us with that.
So that's going well. We're obviously... The other big thing for us to do is to expand our patient engagement. I'd say, I think at this point, we're probably matching the top-tier companies in spend on online, and we'll continue to look for other opportunities to expand even beyond that. So, I think those two levers just continue to build the team and find the spots where we need to build and patient engagement. I mean, it definitely helps. We definitively did not want to launch by doing DTC.
I think for hopefully obvious reasons that, you know, if you don't have the coverage and you can't get access, and you kind of create a bad will. But I think we're in a position, the access team has done an amazing job. I think we're still at about 95% coverage, so anyone who wants to come on to Briumvi should be able to come on to Briumvi. So I think we're in a position, and we've educated a really, I'd say, the vast majority of the key MS folks out there, so no one's gonna be surprised when a patient walks in and says: "I'd like Briumvi," and they're not gonna be like: "I've never heard of Briumvi.
Right? So that was the other part of our plan, was to make sure that doctors are all conditioned and prepared. So the next step is to engage the patients. So long term, you know, I continue to see that the revenues will grow. You know, our goal, I think you mentioned it earlier, in passing, our goal is to be the number one prescribed anti-CD20 for relapsing forms of MS. I think we're well on our way. Within the first year of launch, I think our capture has been great, but we haven't reached our goal yet, so no one will sleep until we do. But yeah, like I said, I don't think it's gonna happen, said previously. It's certainly not gonna happen this year.
and probably not next year, but I don't think we're many years away from potentially achieving that goal. And, you know, it's obviously a lofty goal, and we've got lots of competitors. Well, two. But, you know, I think the team is committed to it. The feedback we get from clinicians... You know, I think the last piece of the puzzle to come together is the more patients that we get on Briumvi, the more patients will go on Briumvi.
The more data points they have to talk to a friend or online, associate with someone who's already been on Briumvi and who's had the experience, and I think probably our best patient advocates will be those who struggled on Ocrevus, who came over to Briumvi and had a really nice experience. I think those folks, as they interface and they become a larger group, will just help get more patients over the edge. So we're targeting the number one in dynamic share. Sorry, to be clear. Talk about that. Dynamic share means the new scripts. The other two have a big head start on total patients on, but over time, I think we can get there as well, but dynamic market share is the goal.
Awesome. Yeah, amazing. Yeah, it would be amazing we'd see that. Okay, maybe last minute, you do have a CD19 CAR T, so which is the hottest area—one of the hottest area in the biotech field. So what, what's the rationale behind to, to license this allogeneic CD19? And then what's your development plan there? What you wanna see? Yeah.
Yeah. So when you say hot, you mean crowded?
Yeah. Yeah.
That's a fair-
Close.
fair interpretation. Yeah, the area became very crowded very quickly. The nice part is, very few of the crowded space are allogeneic.
Yeah.
And even fewer are focused in our core hotspot for us, which is MS, right? So I think, you know, we could be first in class and best in class in certain areas, and I think there's other areas that are really just overwhelmed with potential parties. Why did we get into this? Look, I mean, to me, CAR T, CD19 or CD20 CAR T is really an extension of anti-CD20 monoclonal antibody therapy. I mean, if you look at the transition in cancer, you can watch it go from naked antibodies to drugs like ARE, Fc engineered antibodies, to bispecific antibodies, to CAR Ts, and each time you take a step up, you take a step up in activity. So for us, it was really just a continuum of what we're doing.
We've been a B-cell player since 2012. I think we're the only company that can really claim that longevity as a focused B-cell company. Obviously, Roche has been in B-cells for longer, but as a singular focus for a company, we've been there, and having a CAR T targeting B-cells is really just a natural extension. We think the allogeneic platform, assuming it works, assuming any of these things work, but assuming the allogeneic works off the shelf, should be a real benefit.
And, you know, I think folks are probably not thinking about the long-term safety of auto CAR Ts in the autoimmune setting, where you'll have a significant number of patients that will survive long enough to potentially see T-cell lymphomas. So if you had your choice and they both worked as well as each other, I think it's, you know, hard to argue that you wouldn't choose the allo versus an auto for all those reasons.
Awesome. Okay, great. Our time is up, and then, you know, thank you for joining us, and thank you, everyone, for attending-