TG Therapeutics, Inc. (NASDAQ:TGTX) Q3 2023 Earnings Call Transcript

Michael Weiss: Sure. So yes, the BTKs look interesting, I’d say, at this point from a far until we get the Phase III data, which I think is possible that we may see some first Phase III data before the end of this year. We won’t really have a good sense of the exact profile. So I think I’ll reserve too much judgment other than, I’ll say, from a market standpoint, what we do here as folks are more excited about the potential for BTKs in primary progressive MS, where glial cell activation may be or inactivation through BTK could be a really nice mechanism for slowing the progression in the absence of active disease. RMS is primarily characterized by active disease, which is well served by the CD20 class and the convenience of once every 6 months doesn’t seem to fit most people’s high end of convenience factor.

So unless something remarkable happens in the RMS patients, I think most people are looking at it for RMS patients as another oral option, which will compete with the current oral therapies but shouldn’t really compete very much with the CD20s. For primary progressive, again, on the other hand, that could be a potential competitor to CD20s if it performs at a high level. So it’s all data dependent. We’ll see how it looks. So certainly going to reserve judgment. We do have our own BTK. We’ve been hanging back. We have a lot of information in cancer patients about the profile of our drug. So we know what it looks like, we can move pretty quickly once we decide to pull the trigger. But we’re going to sit back, let’s see some data come out. Let’s identify if there’s an opportunity to fit in to the space, and we’ll go from there.

So we’re all waiting on the data for the moment. Thanks, Prakhar.

Operator: Our next question is from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan: Congrats on the strong quarter. Maybe — can you give us a little bit more color? You said the momentum — you’re seeing the momentum continue past the end of the third quarter. Can you give us a little bit more color in terms of what you’re seeing in October? And I guess maybe more broadly, do you expect to see any seasonality to the business at all?

Michael Weiss: Sure. Adam, do you want to go ahead and take that one?

Adam Waldman: Sure. Yes. Thanks, Matt. I appreciate the question. I think we’ve given guidance for the quarter. And at this point, I’m not going to get into any fourth quarter trends. I think the guidance will speak for itself there. In terms of seasonality, yes. I mean we did see some seasonality — and we talked about this a little bit on the last call, we did see some seasonality over the summer months. In fact, when we looked at it, there is a sort of a dampening across the entire MS market in the summer months. We saw a slower July, followed by stronger months in August and September. But we do see — at least we saw in early July and into July, a slowdown. And I think as people go on vacations, people go out of the office, it’s natural, especially for infusion-based therapies and we are seeing that again with other IV CD20s as well.

So we did see that seasonality there. We’re just launching, so we’re continuing to look at the trends and trying to figure out what we might see from season to season. So hard to say what the future will bring. Of course, around holidays, when people don’t want to get infused, that’s a natural time where you’ll see slowdowns. But other than that, I think we remains to be seen as we continue to move forward.

Matt Kaplan: Adam, that’s really helpful. And then, Mike, I think you commented on this in terms of in your prepared remarks. But can you talk a little bit more about the anticipated impact of the subcu, specifically subcu accretive into or on the anti-CD20 space in MS. And how important it is — is it for you to have a subcu offering?

Michael Weiss: Sure. Thanks, Matt. So yes, so if you take developers of subcu at their word in their last teleconference, they made it, I thought, pretty clear that they were going to use subcu to expand the market for the drug. So I don’t think that it’s a major competitive threat to IV CD20. I think their primary goal, again, I can only base it on what I heard and when I guess how I interpreted what they said. So I don’t think it’s going to have a major impact. I think they are going after that part of the market that has been reserved for subcu. One company has a monopoly in that area today. And I think the new subcu will try to compete for the extra convenience of a 1 on an every 6-month infusion. So I do think that it’s going to have limited impact on the IV marketplace.

In terms of the importance of us having a subcu. Again, it’s not important from a primary goal for us, right? So our primary goal is to make Briumvi the number 1 prescribed dynamic share IV CD20. That’s what everyone in the company is working toward. So that’s — and I don’t think a subcu Ocrevus is going to impact the overall IV market and our ability to potentially achieve that goal. Is it a potential area for us to expand and create a new market for Briumvi? Sure. And if we get to a point where we think we can develop a subcu that has a profile that is competitive with what’s out there and available, we do think that, again, the subcu market is growing. We think they’re building into general neurologists and other neurology practices that have not historically used a lot of IV CD20s.