All right. Welcome, everyone, to Day One of Cantor's Global Healthcare Conference. My name is Prakhar Agrawal. I'm a Biotech Analyst at Cantor. And for our next session, we are very excited to host the team of TG Therapeutics and representing TG. We have Mike Weiss, Chairman and CEO. Mike, thank you.
Thanks, Prakhar. Appreciate it. Great to see you.
Yeah, I mean, so obviously, you announced some news today morning as well with the share buyback, more authorization. Congrats on that.
Thank you.
But maybe to level set expectations, just start off where you are with the launch of BRIUMVI as you look two and a half years since the launch and the key priorities from now.
Yeah, so again, thanks for having us. And yeah, the BRIUMVI launch, like you said, about two and a half years ago, February of 2023, right?
Yeah.
Get my dates right. So I mean, since the launch, things have gone better than expected. I think from internal projections and Wall Street projections, I think we've exceeded expectations in every quarter and even every year, year- over- year, we just continue to perform. So I think that's all going great, and we're super excited about it. The team has executed well. I think in terms of priorities going forward, I think one thing the team has done great and by design was to focus on the healthcare providers. So the first two-plus years has really been about educating the healthcare providers of the BRIUMVI, what we call advantages. What we haven't done by design was really done a lot of direct-to-patient programming. So we are now, I think, full swing into doing that. We've been encouraged by clinicians, which is great.
I mean, it's nice for them to ask us to do these direct-to-patient programs, and so that's a big push for us. We have our first commercial out on TV. For those of you who still watch TV, I do, but no one else does, but we also have it on, I guess they call it connected TV, which is all everyone else is watching, apparently, the Hulu's, the Netflix, and everything else, but so it's out there. Commercial is great. My wife saw it twice last night. She was super excited. I fell asleep, so I missed it, but it was great, so yeah, so that's going to be a big push for us. I think that'll be a nice tailwind for us as we move into the rest of the year and next year.
Yeah, and so on the profile, in the last two and a half years, there were multiple attributes that you had highlighted as a differentiation when the product got launched. But what do you think has resonated most with the physician community on the profile of the drug?
Yeah, I'd like to say I have a good answer as to which resonated most. I think, as you mentioned, there's a lot of attributes. I think the nice part has been there's something for everyone, right? So efficacy, as you know, in our phase III trial, it's the only drug in the MS class that was below an ARR of 0.1. It was actually 0.81 or 0.79, which implies less than one relapse in every 10 treatment years. After five years of follow-up, we presented last year, the annualized relapse rate went down to basically one relapse in every 50 treatment years. So pretty remarkable activity of the agent. So that obviously is attractive to folks. The tolerability profile is something that we get a lot of enthusiasm around. The infusion for the competitive product sometimes is quite challenging, we hear.
And not only is it challenging during, but even after, and sometimes even weeks after. I've spoken to a lot of individuals who were on that drug, who are now on BRIUMVI, who just have a much better tolerability of the infusion. And again, it's one hour, so it's convenient to take as a one-hour infusion. But it's also the tolerability is kind of built into that one hour, right? If it wasn't tolerable, you couldn't give it in one hour. So I think it all comes together as a package. There seems to be something that people pick up on, whether it's, like I said, the efficacy, the tolerability, the convenience. All of it comes together, I think. And then for those who don't think there's any difference between the two agents, because there are some folks who believe that, we still are about a 25% discount.
So if you think they're the same, why would you pay more for the other product? Doesn't make much sense, right? You don't do that.
I'm price sensitive.
Of course you are, and everyone is, so anyway, so yeah, I think there's a lot for everyone, but not one thing I could point to.
Okay. And maybe just talk about the market right now on the CD20 market, both IV and subcutaneous. What's the share of the CD20 drugs have? And are we seeing some sort of peak happening for the market for this class, or are you seeing more growth? And where's the growth coming from?
Yeah, so it's definitely over 50%. And in some quarters, it seems like it's over 55%. But the information we have is claims data. It doesn't cover the entire market. So it is hard to tell. It does look like it is trending northward, but it's not a linear line. I think there's definitely some variability quarter to quarter. But I always, I mean, for simplicity purposes, I think it's 50+ makes it easier for me to do the calculations of market share. But yeah, it's definitely trending upward. And that's the dynamic share, right? So to separate dynamic from total. So the dynamic share is about 50%+ of new starts. And again, it could be as high as 55%. The data is not perfect. And we think it is trending northward. The total market share is not quite 50% yet, right?
That's going to take about five years. It's about a five-year lag-ish between the dynamic share to the total share. We haven't seen the total share come even close to peak. That is the bigger part of the market, obviously.
Okay. Got it. And I think last quarter, you said one in three dynamic patients for BRIUMVI in the IV CD20 class is coming over to BRIUMVI. And you have obviously highlighted your ambitions for it to be the leading drug in the class. So what do you think takes to achieve that?
Yeah, I think it's probably time. It's a competitive market. Like I said, we're approaching about one in three of the IV patients going on BRIUMVI. But it's not like the competitor is going to roll over and say, "Here, take the rest." So it's just time. I mean, we're in the market for only two and a half years. We continue pretty much quarter over quarter. We continue to grow. We continue to capture market share. So yeah, I think we just need a little more time. I mean, I talk about it all the time, but two years ago, pretty much close to today, Adam Waldman said we were going to have nice steady growth, and he's delivered the most beautiful steady growth I've seen ever. So we'll continue to do that, and we'll continue to capture market share.
Okay. During the Q2 call, you raised your guidance once again. Stock probably did not react that positively to the guidance raise. Maybe what's the comfort level with the guidance? Maybe just talk about the guidance philosophy in general, because we get a lot of questions around you're super conservative on guidance, but do you really need to be that conservative? First, go through that, and then I had a few questions.
I think on a positive side, people understand that we're being relatively conservative. Our philosophy is the worst thing we could do is miss guidance, right? It's not that we can never miss the guidance that we're giving, but we have a pretty high level of confidence in the number we're delivering. It's not an aspirational number, right? It's not like, I mean, and I didn't know this was a thing, but I've recently seen with other companies, they just throw numbers around, and then when they miss them, they just adjust. We're not in the game of providing aspirational projections. If we're going to give a number, we're going to give a number that we have a high level of confidence in achieving. Is there room on the upside?
There is, but as you've seen over the last few quarters, yeah, we may have come in. Actuals may have come in $2 million-$3 million above what we projected. To me, that's kind of dead on. The precision in this business, if you really believe there's a precision required, you shouldn't be investing in biotech. If we come in $2 million above what we came in, that's not being that conservative, right? We're pretty much dead on, and that's what we're trying to do. We're trying to provide good, clean guidance so people don't have to go off and make up their own numbers, try to do their own calculations. No one, I could assure you, there's no hedge fund analyst in this country who has access to more information to project what we're going to come up with a number than we do.
If you think that you're smarter than us and our modeling team, you're just making numbers up. For the bosses out there who watch these kids do that, they should shut them down.
Or maybe you can hire them.
I wouldn't hire them.
But maybe on the second-half trends, obviously, 3Q tends to be a little bit seasonal for the MS market.
Yep, yep.
So what are you seeing in 3Q so far?
Yeah, 3Q, not so bad. I mean, July was another record enrollment month for us, so that was great. August was pretty much as expected, pretty slow, but pretty much as we expected. So yeah, I think we had a pretty good summer, all things considered. But yeah, I mean, like I said, July was a record, so we were pleasantly surprised with that. August, it's just a slow month.
For the market.
For the market, yeah. I mean, no one wants to get infused in August. And last year, most people didn't want to get infused in July, but this year seemed to be a little different. But overall, perfectly good summer, similar to what we would have expected.
Okay, but is the seasonality similar to what was seen in the prior years? Is it a little bit different because people will start to make year-on-year comparisons, right?
Yeah, I don't know. I mean, it's a summer.
Okay. The other sort of pushback in 2Q that we had received was on the gross to net being a little bit on the higher end. Maybe just talk about the discounting dynamics, what's going on?
Yeah. That's an interesting question about the gross-to-net. So I know Adam's been really good about saying, "Look, it's going to range between 70% and 75% during the course of the year. Some quarters up, some quarters down within that range." And it's always about a mix of business. Probably the biggest driver is 340B hospital utilization. If they are up in a quarter, the GTN is going to be down. If they're down in a quarter, GTN is going to be up. But what I'd say is I'm not really sure what that information does for anybody, right? If we're giving you the number, when we give a revenue number target, it's the net number. What are you calculating? What is anyone using that for?
For forecasting.
In quarter- by quarter or for long term?
For quarter- by- quarter.
But why? I gave you the number. What are you forecasting? And my number has been pretty good.
It matters, I think, what the bigger picture is, that it matters for the evolution of the gross-to-net. So if your gross-to-net is increasing, people have to model accordingly. So I think that's the bigger question, that how should we sort of forecast the evolution of gross-to-net?
Yeah, and I think we've said repeatedly that for long-term modeling purposes, the net price today is probably the net price a year from now and the next year. The goal for probably every company, I assume, is the GTN goes down, the price goes up a little bit, they balance each other out. So if you're trying to figure out long-term modeling purposes, it's not unreasonable to use approximately the same net price we have today.
Okay. And as we look forward to the next year, I know it's a little bit early, but we're already sort of thinking about some of the modeling assumptions there. Anything that we should be aware of regarding, let's say, BRIUMVI's access situation than what you have right now?
I hope not. Right now, we have great access, I think greater than 95% coverage across the country. So we've got great access. We want to do what we can to keep that access. I don't have any information that tells me we're not going to be able to do so. But yeah, I mean, it is a repetitive game of negotiating with folks all the time. But yeah, I think we're in good shape. I think we're in good shape.
Okay. And you mentioned about the direct-to-consumer investments as well. What's the level of investments there? And what is the ROI? What is the early feedback on these investments?
Now, that would be a good thing for you guys to model. That would be fun to figure out how you can calculate ROI on marketing advertising dollars. I know the team is working on it. It's a challenge. So it is not a number that is easily calculatable, but we will do our best, but it's too early to count on ROI at this point.
Because the DTC investments can be a little bit expensive. What's the level of investments that you're making right now?
Yeah, so I don't have the exact dollar amount of the investment. It's something we can work on. I mean, obviously, it's in our OPEX, but not specified. So fair point. But I don't know it offhand. But yeah, I think we are trying to spend money on that area. We think it's important. We do gauge patient awareness. We do sort of, I think, every six months or so, we do patient awareness surveys to try to see if we're kind of pushing that. That is the ultimate goal, to have a very high level of patient awareness. It does seem to be ticking up probably over and above what we would have expected through the last three or four months. So we'll keep you posted. But to me, that's the number one gauge, is looking at patient awareness.
Okay. Got it and on the competition, anything that you're hearing from, let's say, IV Ocrevus or subcutaneous Ocrevus in terms of impact to BRIUMVI?
Not that we're seeing. But to be fair, we don't know the counterfactual, right? So if subcutaneous Ocrevus didn't exist, would we be something different? It doesn't appear. I mean, we continue to grow. We're growing at the rates and above the rates in which we anticipated. So it's hard to really see any impact. But we wouldn't know either.
Got it. And maybe just longer term here, because one sort of, again, pushback that I get is what happens to the IV CD20 market when Ocrevus loses exclusivity, right? And you obviously have a different view here. Just explain what do you think will happen?
I do. Prakhar's heard me talk about this a little bit, so I could see. Yeah, I do have a different viewpoint. I actually view a biosimilar Ocrevus as an opportunity for BRIUMVI, not a threat. We think the compounds are sufficiently differentiated that we would not expect a deterioration of our market share. I would expect our market share to continue to grow in the face of a biosimilar Ocrevus. I assume their market share would go down and they'd lose it to the biosimilar. But remember, we're already at a 20%- 25% discount to Ocrevus. And as you can see, it wasn't like the payer said, "Oh, well, you're at 20%- 25% discount.
Everyone must use BRIUMVI." So I don't even anticipate that if a biosimilar came to the market and they put themselves at a 20%-25% discount to us, which would be about a 40%-50% discount to Ocrevus, that anyone's going to say, "Well, now everyone's got to use the biosimilars instead of BRIUMVI." So I just don't see that happening. There's only a few analogs out there, and none of them are really even close to on point. But there has been, in the MS setting, there was price erosion. But remember, that's a pharmacy benefit product. That's not a buy-and-bill product. There's definitely different dynamics at play. It's much harder to lower price in this setting. You put doctors and hospitals underwater. That becomes a problem for them. So it's a different dynamic.
So I think from a pricing standpoint, I think there could be some price negotiation at that time. But like I said, we're already at a pretty good discount to the competitor, and we'll have a much bigger base of business at that time.
Okay. And so given this sort of debate about the long-term peak sales opportunity for BRIUMVI in the U.S., any thoughts on giving long-term guidance?
No one seems to care about my short-term guidance. If I gave long-term guidance, what do you think they would do with that? I mean, we are, again, just to be clear, we're not about giving aspirational numbers. So if we give a number, we got to really feel confident we're going to make it. I think for the moment, our short-term guidance is we're comfortable that we're going to hit the $570 million-$575 million for this year. And then early next year, we'll give a 2026 guidance. I think there's probably a point in time where we can give a little bit beyond one year of guidance. But I think I've said this many times. The modeling for this is not at all challenging. Actually, I think you understand how to model this.
I think if anyone is interested in taking a look at it, someone who knows how to model, you might want to take a look at Proctor's model. But generally speaking, it is not challenging to model this out. The accumulation of patients is really where the market is. Like I said earlier about dynamic share versus total share, the dynamic share, the dollars in the dynamic market are a fraction of the total market. And anyone who's trying to model just from dynamic share what the peak is are not understanding the modeling challenge here. But anyway, so we're not going to give long-term guidance, but I don't think it's challenging to figure it out from where we are today.
Okay. Maybe onto the pipeline. Obviously, the subcutaneous BRIUMVI is an important piece of the story. In 2Q, you noted you will be testing both quarterly and every other month dosing in pivotal trials. What are the key risks as you move into pivotal trials? Because we haven't seen the data, but it should be straightforward PK data that you would have seen. So maybe just walk through as you move into the pivotal trials, what should be the expectation?
Yeah, absolutely. So we'll start with the study design. It's relatively straightforward. It's a bioequivalence PK non-inferiority area under the curve. If you've looked at the Ocrevus subQ trial, you pretty much have a good sense of what this trial looks like. The difference is we're taking two dosing intervals forward every other month and every three months. So at least we'll have a good look, a little bit of a dose response, and understand the kinetics of the bioavailability. The data we have from phase I, yeah, it's short-term bioavailability information. From that, they can model out what they think the bioavailability is. There's a pretty decent range around that. So the confidence interval around that number is still relatively wide. But I think it would have to be outside the range probably for the every other month to fail.
Every third month, we think, is in the range of reasonable possibilities of being successful based on what we know about the PK today.
Okay. And can you talk about the device presentation that you're aiming for and the injection volume versus what your competitor has?
Yeah. So there's two subQs. For those of you who can't see, I'm making hand quotes. So Kesimpta is a true subQ. Autoinjector, put it on your body, hit the button, and in two, three, four, five seconds, I don't know exactly how long, but it's relatively quick. You get your dose. The Ocrevus subQ is a 20 mL plus, might be 21 product. In an autoinjector, typically you want to be 2 mL or below. Ours is going to be designed to be in an autoinjector at 2 mL or below of material. So it's a different product from subQ Ocrevus, much more similar in terms of the Kesimpta-like profile. Like I said, every other month or every third month, and it should be a relatively rapid subQ autoinjector product.
Okay. And on the subQ Ocrevus, pain and injection reactions was a little bit of an issue, and I think, at least based on the early feedback, still an issue in the real world. So is that driven by just the injection volume, or how would you characterize BRIUMVI's subcutaneous tolerability profile?
Yeah. I mean, typically, the pain injection site is volume to time, right? So theirs is a 10-15 minute-ish subQ push. With an autoinjector, it's going in in seconds. You're putting 2 mL in, but again, it should be I mean, you could have injection site reactions, but there's nothing to extrapolate from the Ocrevus subQ experience. I think looking at the Kesimpta experience would be a much better analog to assess what you might expect for injection site reactions and any other basic reactions of that kind of a product.
Okay. And so how big of an opportunity is it for the subcutaneous formulation right now? And is it just incremental, or do you think that this is a major opportunity for the BRIUMVI franchise?
I mean, I guess it depends how you define incremental.
$500 million.
You could do it in dollars. That's one way. Or you could do it in percentages. Right now, the subQ marketplace represents 40% of the CD20 market, right? That's about another 75%. It's not quite double the market opportunity, but it's about 75% of the original opportunity. For ease of conversation, it's almost double the opportunity. If that's incremental, we'll call it incremental. To me, that sounds a little bit more than incremental, but it's almost double.
Right. Okay. And maybe in the interest of time, I did want to touch on a couple of other pipeline opportunities. Azer-cel , in primary progressive MS, I think you started dosing patients as well. Maybe just talk about the experience there. And obviously, the street is not giving much value to the asset right now, but you have some long-term plans there.
Yeah, yeah. And that's okay. I mean, I can't ask for value before we do much with it, so I'm not upset about that. I think that's fair. But yeah, we're early. We're building momentum. I would say pretty confident we're going to see a lot more enrollment in 2026. 2025 was definitely a year of just getting the system in place. I think it's a struggle to put these sites and get them up and running, but once you get them going, we get the system. So I think the system is about to turn into a machine that works properly. And yeah, so my fingers are crossed that we'll have good enrollment in 2026. Primary progressive is the first indication, but in 2026, we'll have another, I think, four, five, six indications open, and we'll have another bunch of centers open. So things should start to turn.
But right now, it has been a little bit slow, but I think theoretically, I do really like the product. I believe in CAR Ts for autoimmune diseases. I think there's an application there that could be pretty amazing, whether we have it or not. I hope we do, and I think we have a good chance at it. But I think there's room to build on that problem.
You have the opportunity. And maybe on capital allocation, you did announce a new share buyback authorization of $100 million. You did a lot of that in August, I think $70 million or so. Maybe just talk about why you sort of did it right now and the pace of share buybacks over time.
Yeah. I mean, look, we were, as you can see, we announced a $100 million buyback last year. And over the course of 11 months, we bought back about $20 million- $25 million-ish over that time period. So I think the pace was moderate. We were just in the market buying pretty much every day, reasonable amounts of shares. We weren't aggressive. When the stock dipped into the 20s, we just saw a great opportunity to take advantage of that. So we loaded up and finished it off. We put another $100 million in place. And we think if there's another opportunity, we'll buy aggressively. If not, we'll just slowly buy every day. I mean, at these levels, whether it's in the 20s, clearly, we don't believe that it's reflective of the true value of the product.
In the 30s, still way undervalued, but which is why we'll continue to buy. We're not aggressively spending the money because we're still waiting for the big cash flow to start hitting, which will be soon enough. So we'll take our time, but anytime we see a major dip, we'll be aggressive for sure.
You talked about meaningful cash flows. I think, obviously, 2026 onwards, that will start coming in. Is BD part of the long-term strategy here and maybe some major BD because, obviously, the cash flows are pretty predictable and easy to forecast, as you've mentioned?
Thank you, Prakhar. Yeah, BD is definitely a big part of it. We've been very actively evaluating opportunities. We have not pulled the trigger. I think we've been very cautious about what we will do and what we have done. Like I said, all we've done recently is Azer-cel and that was, I think, at least two years ago now, almost one and a half years. But we're actively evaluating. We're building out our BD resources. And our goal is to be active, but when you say major, I don't see us making major acquisitions. I think there's a lot of opportunities for us to build without having to spend a ton of money upfront. I mean, if we have to, I think there's ways to do that efficiently too.
Is the focus more late stage or early stage?
Yeah. I mean, early mid stage is kind of where we're most comfortable. We feel like the first phase of the launch, we'll call it, first major phase, it has multiple little subsectors, is through 2028 to mid-2028 when we start to launch subQ. Then we have the subQ launch. So we're busy. We don't have to build new teams. If I wanted to acquire a commercial product today, again, those things are numbers also, right? So if I could buy something that's reasonably inexpensive and we could turn it into something special, of course we would do it. Those things don't grow on trees in that way. So not ruling it out, but not saying that's the target and we're only focused on that. But other than that, the team is busy. They've got a lot of work to do. They've done a phenomenal job thus far.
We continue to believe they're going to do a great job going forward.
Right. That's all the time we have today, but my pleasure, as always, to chat with you. Thank you for coming and thank you to the audience for listening in.
Thanks, Prakhar. Appreciate it. Thanks, everybody.