TG Therapeutics, Inc. H.C. Wainwright 28th Annual Global Investment Conference
Review the key takeaways and the transcript of this earnings call.
- TG Therapeutics reported that their commercial asset BREMV has been on the market for nearly four years and has captured over a third of the IV anti-CD20 market share, which is estimated to have about 40,000 new relapsing multiple sclerosis (RMS) patients annually.
- In the second quarter, TG Therapeutics updated their revenue guidance to $890 million to $905 million, with key drivers being new patient starts and persistence, the latter becoming more significant over time.
- The company expects improving gross-to-net (GTN) dynamics in the second half of the year, with seasonality affecting both GTN and patient starts, aiming for a fourth-quarter run rate exceeding $1 billion.
- Patient dynamics for BREMV show roughly equal proportions of truly naive patients, those switching from other non-CD20 therapies, and those switching from other CD20 therapies, with the naive patient proportion growing over time.
- TG Therapeutics is developing a subcutaneous (subcu) formulation of BREMV, with phase one data showing about 60% bioavailability and a favorable pharmacokinetic profile, supporting their phase three trial design.
- The company is also exploring enhanced dosing to combine the first two doses into a single administration, which has received positive feedback from clinicians and patients and is expected to impact growth in 2027.
- TG Therapeutics is conducting trials in other indications including myasthenia gravis and treatment-resistant schizophrenia, exploring the role of CD20 in these diseases and potential new treatment paradigms.
- The company’s partnership with Nurexpharm for XUS commercialization is progressing well, with subcu formulations contributing over 50% of dynamic share in that market.
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Transcript
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Good afternoon, everyone, and thank you for coming to the H.C. Wainwright 28th Annual Global Investment Conference. My name is Emily Bodnar, and I'm an equity research analyst at H.C. Wainwright. I'll be doing a fireside chat with Mike Weiss, Chairman, President, and Chief Executive Officer of TG Therapeutics. Maybe to start, can you set up for us the current landscape in relapsing multiple sclerosis and where your commercial asset, BRIUMVI, fits into that landscape compared to other anti-CD20 antibodies?
Yeah, sure. Thanks, Emily. Good to see you. For relapsing MS, we estimate that there's approximately 40,000 new patients per year. Actually, let me double-check. That's for all MS, so RMS and PPMS?
PPMS. RMS. RMS confirmed about 40,000 a year will go on to a CD20.
That's any given year. About 65% will choose an IV option and about 35%, maybe it's 60%-65%, 30%-35%, so it's like 30% to 35% for a sub-Q option, and 65% to 70% for an IV option. Today, there's just one sub-Q option, so it's a market that we don't currently participate in. We participate and compete in the IV market, which includes both our IV product, another IV product, and I guess a sub-Q physician administered sub-Q, which we consider to be, since it's a physician and office based, we view that as part of that competition. Right now, I don't have the exact numbers, but we've been tracking over a third and growing of the IV portion of the market. So things have been going quite well.
We will complete our fourth year of on market as of, I guess, February 1. So, I think we've done an incredible job of breaking into a very competitive marketplace. I think that's probably the RMS market, just generally speaking. That's probably a good start there.
Yeah. BRIUMVI obviously has done very well. You've kind of beat your guidance pretty consistently. In 2Q, you updated your guidance to $890 million-$905 million. What metrics are you kind of estimating to go in that, and is there a bit of conservatism in that guidance?
In terms of the metrics that go into our projections, probably the two biggest will be new patient starts and persistence. What's interesting over time, persistence becomes probably the biggest variable, because we estimate from a competitor product that the median on CD20 is about five years. Right? So after a number of years, what you notice is that the repeat business becomes a bigger portion of every quarter. Right? So only a smaller portion is going to be based on those new starts. So persistence and new starts, those are the two biggest variables that we look at. Gross to net changes, so mix of business will have an impact. Remember, again, as that GTN goes across a bigger installed base, and repeat business changes, GTN can have some material impacts. They are, just to be very clear, GTN does fluctuate quarter to quarter.
That will have some impact, and there's just natural variables that change that GTN on a quarter-by-quarter basis. Those are probably the biggest three. There's a few other variables that will go into it, but I'd say those are the biggest three.
Okay. Maybe walk us through the second half of the year, how we should be thinking about revenues, any seasonality or gross net expectations for the remainder of the year?
Yeah. The nice part, the second half of the year does benefit from improving gross to net. The first quarter, if you talk about seasonality, there's seasonality in both gross to net. There's seasonality in terms of those 40,000 dynamic share patients. One is the first quarter of the year is usually the lowest GTN. Then it typically will sort of slowly climb during the course of the year. You get a little bit of a tailwind from GTN changes. Whereas you also have in the summer, you probably have the lowest portion of that 40,000, right? It's not linear, it's not 10,000. Every quarter's slightly different, and certainly the third quarter is going to be the one that has the smallest dynamic market available. But again, you get some benefit from the GTN.
Those things sort of hopefully balance each other out in some proportion, some way. As we've said, based on the call, we're looking for ending the fourth quarter with over a billion-dollar run rate, which is what we've really been focused on and targeting. We're pretty excited about that. That'll be a big milestone for the company.
Awesome. Maybe walk us through the dynamics of new patients going on BRIUMVI. Is it all newly diagnosed patients, or do you have patients who are switching from Ocrevus or KESIMPTA, and has that dynamic changed over the years?
Yeah. That's really interesting, and I do have some fresh information on that. It's not like it's not MNPI, but information. But we've recently did a new look and I had an original look that was six months into launch, and the pretty interesting part, two pieces that are interesting, one of which may be obvious, one of them may not be as obvious. The one that may be obvious is that the proportion of truly naive patients has grown over time. Right. You can imagine you launch a new drug, maybe the newly diagnosed patients are the ones you're not going to put it on immediately, and you'll put on sort of later stage patients. That proportion has grown over the last two and a half, three years since our first data.
The one that might be surprising is that the proportion of patients coming on from other CD20s has basically not changed. It has been very consistent, and in fact, at this point, these three groups are almost equivalent. I say three groups, and we only talked about two. One group is truly naive. The second group is coming from something other than a CD20, and then patients who come to us from another CD20. Those groups are essentially equivalent now. I think in the past, I've described them as a little bit imbalanced, pretty equal, but they're really much tighter today than they were. But like I said, the distribution has been more naive, which has outpaced from transfers from other treatments. But the CD20 switches have really maintained rock solid since we started, which is pretty amazing quarter over quarter.
Yeah. Walk us through how it's decided what therapy patients will go on within the anti-CD20 class. Is it more patient-driven, formulary-driven, physician-driven?
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