TG Therapeutics, Inc. (TGTX) Earnings Call Transcript & Summary
January 13, 2026
Earnings Call Speaker Segments
Lut Ming Cheng
AnalystsGood afternoon, everyone. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the senior biotech analysts here at the firm. On stage, we have Mike Weiss, who is the CEO of TG Therapeutics. I'll now pass the mic to their CEO for a short presentation, followed by a live audience Q&A. Mike, the stage is yours.
Michael Weiss
ExecutivesGreat. Thank you, Brian, and thanks, everyone, for joining us. I'm going to get started here. Just before I do, let me just mention that I will make some forward-looking statements. For those of you who are interested, I do encourage you to review our public disclosure documents available on the line. Just a way of quick background for those of you who may not be that familiar with TG Therapeutics. We were founded in 2012 with a focus on B-cell-mediated diseases. These can range from autoimmune diseases to neuroinflammatory as well as cancer. But today, we're focused primarily on MS. We have one approved drug, BRIUMVI for multiple sclerosis, which is approaching blockbuster status. We have 2 pivotal trials ongoing to expand the utilization and total addressable market for BRIUMVI, and we have 3 programs under development. So there it is BRIUMVI. This is our approved anti-CD20 monoclonal antibody. It was approved in late December of '22 and launched in January of '23, so a little under 3 years ago. And -- but not only is available in the U.S., but it's available now globally. Our partners at Neuraxpharm are commercializing it across Europe and the rest of the world. It's now available in 16 countries. And to date, over 20,000 patients have been prescribed BRIUMVI, most of those in the United States. So I'm going to drill down a little bit on the anti-CD20 market, which is the one that BRIUMVI competes in. It's -- that market itself captures about 50% of the dynamic market share, so that's the new prescriptions and also has about 50% of the overall market share. And what I'm going to share with you is that we expect BRIUMVI to grow with the sector because remember, we only have -- CD20's only have 50% market share today. So there's still room to grow. And then I'm going to show how we're going to grow within the CD20 sector. So today, there's about $10 billion in sales for this class of drugs. And just to frame it out, there's 3 anti-CD20s approved for MS, again, one of which is including BRIUMVI. I'm going to refer to this slide twice today. So you'll see it now, you get to see it again later, so you don't have to memorize it momentarily, but we're going to talk about it in a few. So this is the market within -- this is the DMT market basically that is only the CD20 portion. And what you can see is that about 65% of the patients choose to go on an IV CD20 and about 35% choose a patient-administered product. So that's a subcu product that you can do at home. We are competing in the HCP or health care provider administered space with BRIUMVI. And then on the other side, that 35% market share is covered by one single agent, but hopefully not for long. So we're going to talk a little bit about our efforts to compete in that space as well. So despite this competitive market, our goal is to be the #1 prescribed anti-CD20 in relapsing forms of MS based on dynamic market share. And I'm going to talk a little bit about how we got to the point we're at today and how we're going to get to this number. So we've seen significant uptake in our portion of that market, that HCP administered anti-CD20 portion of the market in less than 3 years, and I'm going to go through some stats with you. Greater than 97% of the top 200 MS centers are using BRIUMVI. Approximately 90% of all high decile -- decile health care providers are prescribing BRIUMVI. That translates to about 1/3 market share in our portion of that market, the HCP administered portion. So essentially, 1 in every 3 patients who chooses an IV product is choosing BRIUMVI. And overall, that brings us to about a 20% total market share, give or take. In terms of revenue, what does that translate into in revenue? So cumulatively, well, as of the end of the year, we had $992 million in cumulative revenues in less than 3 years. As of today, fresh update, I'm sure, this is unofficial number, but I'm sure we've crossed over $1 billion in cumulative net sales as of 2 weeks into the year. And then let's talk about 2026. We had a really nice year, $616 million in total global revenues. And then for the portion that is the U.S., which is most of it, $594 million this year in BRIUMVI U.S. net revenue. That represents about a year-over-year. And we ended with a really solid fourth quarter. We had $182 million in the fourth quarter. We were targeting about $175 million for the quarter. So a nice outperformance and had a really nice growth, 20% growth quarter-over-quarter Q3 to Q4. And even for the year at $594 million, I think when we started the year, which is why it is challenging for us, for any company, I think, to give guidance 2 weeks into the year for the full year, we were predicting and targeting about $525 million in revenues at the start of the year. We ended up closer to $600 million. So a really fantastic year. The team performed great. BRIUMVI was very well accepted, but it does show some of the challenges in forecasting. So how have we gotten to this point? Really nice revenues, really nice market share continuing to grow. We have a tagline that is first and only anti-CD20 for MS that's delivered in a 1-hour infusion every 6 months after the starting dose. It's a nice catch phrase, a little long. We could probably come up with something shorter and better. But to start, that's pretty good. But it's not -- it doesn't tell the whole story, right? The whole story is we believe we have a best-in-class product. We've hired the best-in-class people, and we delivered it at the best-in-class price. And I think if you look at any business, if you could deliver those 3 things, you're going to do pretty good. And that's, I think, why we're getting there. I'm going to drill down a little bit here on the -- some of the profile here. The product has shown consistent efficacy and safety over a 6-year period. In our pivotal Phase III trial, we had the only CD20 that came in with an ARR under 0.01. And after 6 years of treatment, the annualized relapse rate is 0.012, which translates roughly into 1 relapse in every 83 years of treatment. So not too shabby, I would say, pretty good data there. The label also is without breast cancer risk and colitis. This is a patient population that skews to women, maybe over 70%, 75% and it skews to younger women, sort of 40 -- 20s to 40s. So that's something that people will take into consideration. This agent has also been glycoengineered for enhanced ADCC. In other diseases where they've actually compared antibodies that have not been ADCC versus ones who have been engineered for this. In those diseases, the ones with enhanced ADCC have performed better in clinical trials. We do think that, that accounts for the efficacy and activity of our product. And then the people. We hired a team of folks who knew the MS space. They come from major companies have been doing this for years. We put literally an all-star team together from every company that's been involved in MS and you can see years and years of experience. And then we wrapped it in this customer service model. It's almost this obsession with making life easier for folks to get on to our drug. And I think that's probably one of the more important things that is not fully realized. If you're difficult to deal with companies -- getting patients on drug is not as simple as just writing a script, especially when it's an IV product, being there and being helpful to getting those patients on whatever you can do to be helpful, it makes a difference. And then on the price side. Some may say, if you come in with the best-in-class product, you might want to charge a higher price. We did somewhat the opposite. We came in at the lowest price of any branded MS treatment, not only of any CD20 treatment, but any branded CD20 -- I mean any branded treatment at all. And we think that definitely has the potential for some savings in the health care system as people transition over to BRIUMVI. And the other thing we're really proud of is that in a closed bidding process, we outbid 2 major foreign pharmaceutical companies to win the VA contract, Veterans Administration contract. And in doing so, we're offering to our veterans anti-CD20 at the lowest price for BRIUMVI available in the U.S., and I believe it's probably the lowest price available in any major country. So we were very proud to be able to do that. So -- that's a little bit how we got to where we are. Now I'm going to do a little forward-looking. Where are we going? What are we going to do? '26 is a relatively straightforward year. We're going to build on what we've done with our health care provider engagement. We're going to amplify patient awareness, and we're going to continue to drive market share. On the HCP side, we've probably doubled our field force since we launched. That was by design. We started, as you can see, a few slides earlier, I said the 90% of the top decile doctors are using BRIUMVI. That was not by accident. That was deliberate. We hired a team focused on those clinicians, and we've expanded basically beyond that, beyond that. And now in year 4 of our launch, we're really looking at a more strategic surgical precise addition to our team to increase reach and frequency with high opportunity health care providers. Those are actually defined by a proprietary targeting algorithm that our team has created. So it's really a nice approach, really targeted. I think in terms of -- like I said, we probably doubled our sales force to date. We're probably this year, a little more modest, maybe a 10% to 20% increase in the field force to address the targeting that we want to do this year. Now the next piece of it is the patient side. In MS, maybe more so than some other diseases, there's a lot of patient involvement in the decision-making, they call it shared decision-making. So getting out to the patients is important. We started out in the first 2 years, we didn't do a ton of this because we were really focused on the clinicians. And the idea was we didn't want patients going to clinicians that didn't know about the drug. So that was very deliberate, I think, very effective in our efforts. But as we grow and we want to build further, patient awareness is going to be key. In 2025, we did a lot of really nice things. We learned a lot. We're taking it forward. We're really leaning into the patient awareness campaigns in '26 across television, digital channels, again, to really build that patient awareness and to continue to help us drive our market share. Beyond '26, we've got a nice group of potential launches coming, which we also think will continue to drive growth. First one is scheduled or targeted for 2027. This is an improvement or enhancement to our IV protocol. We're going to talk about it momentarily, but this is a consolidation of 2 doses to simplify the onboarding to BRIUMVI. We've gotten a lot of good feedback from clinicians about this idea, and I'll describe this in momentarily with the clinical trial. In 2028, the hope would be to launch our BRIUMVI subcu. This is -- this could be a very material product for us. And like I said, I'm going to spend more time later, so I'm not going to say too much now about that one. And then as we move into 2029 and beyond, we think there's an opportunity to launch BRIUMVI in additional indications outside of MS as well as novel drugs. We have azer-cel in our pipeline, which I'll talk about. And we also have an active BD development program, which we think could lead to launches in this time frame. So it kind of really lines up nicely with what we're doing. So let's talk about the first one that I was referring to. So the consolidated dosing to simplify the onboarding basically to IV BRIUMVI. So we have our ENHANCE pivotal trial. And essentially, we're comparing the approved IV dosing, which you can see on the left-hand side. And what we do, like every other CD20 that's given an infusion, you do a day 1 dose, you do a day 15 dose and then you start again 6 months later and you give -- in our case, you just give 1 infusion every 24 weeks. The proposed IV dosing now would be basically to combine or consolidate day 1 and day 15 into a single dose. And like I said, when you talk to the clinicians, the centers, it's surprising how much let's call it inconvenience. It's not like the end of the world, but it is inconvenient for them to have to schedule 2 doses within 2 weeks, and it's also inconvenient for the patients. So we'll be the only IV product in MS that's approved if we get successful, just start, you're on and you don't have to come back for 6 months. This study is fully enrolled. Top line data is expected in the middle of this year. And the target launch, as I discussed previously, is for 2027. All right. Now let's focus on something that's, I think, super exciting. The development of a self-administered subcu BRIUMVI. So we have a pivotal study that's up and running. And again, very similar. If you look at the left side of the panel, it's essentially the approved IV dosing versus the proposed subcu dosing, and our goal is to match basically PK over a 24-week period. Getting approvals, 24-week period. And you can see the schedule here, very similar to the approved IV dosing, except it's with an injection. You get a dose on day 1, you get a dose on day 15 and every either 8 or 12 weeks. So we have 2 arms. 1 is looking at every other month dosing. 1 is looking at every third month of dosing. The target profile, again, here is to be a self-administered subcu with an auto-injector. So something very comparable in terms of format to the one compound that I referred to that's approved as a self-injectable. So we're very excited about this study update. The Phase III trial is greater than 50% enrolled. Top line data, we're expecting toward the end of this year into early next year. And again, as I mentioned, with a target launch potentially in 2028. I told you I was going to come back to this picture. Hopefully, you guys didn't forget that. So why are we so excited about subcu BRIUMVI? Again, this is an opportunity to significantly increase the total addressable market. Now we are competing right now in the larger portion of the market that's at 65% seen there, but we have no way of competing today in that 35% of the market. So one of the key threshold questions asked the patient, once the clinician and the patient decide that the CD20 is the right treatment for them, the threshold question is, do you want to inject yourself? Or do you want to come in and get injected by or infused by a clinician, right? Right now, about 35%, sometimes depending on the month and the quarter, it could be up to 40%. But on average, about 35% of the patients are choosing that. If they choose that option, we don't compete, right? We don't have an offering for them today. So that's why this is so important for us and exciting for us. So this is something that just completely augments our IV business. This does not cannibalize any business because, again, if you're choosing the at-home option, you're going to get it. So this is really nice. It gets us into a unique and distinct patient segment. It positions TG as the only company. And for the foreseeable future, I don't see anyone else that's going to get there with an offering in each of these markets. So one where you can go to your doctor and get it or the other, you can do it at home. So we're really meeting the doctors and the patients, where they are and where they want to be in their treatment. And then the final piece, which is from a financial side, I think somewhat incredible. I mean there's -- I know there's lots of opportunities to launch drugs in new indications and new diseases, and we will probably do that eventually, and we're working on some other areas outside of MS. But the leverage of doing something within MS is really incredible. So this is something where we will use essentially the current commercial infrastructure with minimal incremental cost. And just to give you a sense of what that means in one particular part of this, about 85% of the target health care providers that are prescribing the self-administered product are already covered by our field force. So really very little additive cost of entering this market, all potential upside. So I'm going to go now to that third bullet in that escalating slide earlier, expanding BRIUMVI in MS beyond MS. So -- we have definitely ideas for how we're going to grow the BRIUMVI brand. I think one thing that people don't fully appreciate with BRIUMVI, and that's probably our fault because we've been very hesitant to move forward in different indications while we were building out the MS platform. But I think as we develop subcu BRIUMVI, I think it reignites the concept of BRIUMVI as a pipeline and a product. And many of you are aware that we've already started a Phase I trial with patients with MG, and that is ongoing. And we're in the process of evaluating a number of other potential indications for BRIUMVI. And then, of course, as I mentioned earlier, we have azer-cel. This is our allogeneic off-the-shelf CD19 CAR-T product. We're in patients with progressive MS, again, starting in our home base, which is MS. We're hoping to have some data from this study in this year, 2026. And we're moving into additional indications, NMO, MG, CIDP also should be open this year. So just to finish this -- just to finish this thread, let's talk about some of the R&D goals while we're on the subject. So as I've described, we're looking to present midyear top line data from the ENHANCE trial. This is the consolidation of the doses. This is certainly not in the order of importance, but certainly in the order of chronology. Middle of the year or second half of the year rather, we're looking to present data from our azer-cel progressive MS cohort. And then as I mentioned, later in the year or early next year, top line data from our subcu program. So very data-rich 2 pivotal readouts this year or maybe leaking into early next year and potentially some data on a very novel product and program. In terms of new trials, we'd like to be in a position, and we'd like to start a registration-directed trial this year for BRIUMVI in an indication outside of MS as well as commence an additional series of potentially exploratory studies for BRIUMVI and as you heard, azer-cel in a number of new indications as well. Anyone interested in some financial guidance for the year, waited to the very end, hope we peaked your curiosity. So we're very excited about 2026. As we've said before, we see BRIUMVI well on track to becoming a multibillion-dollar franchise in the United States. In terms of guidance for global net revenue for 2026, we're starting off the year targeting approximately $875 million to $900 million for this year. And most of that, again, is going to be from our U.S. net revenues of BRIUMVI, approximately $825 million to $850 million in BRIUMVI U.S. net revenue. And then on the expense side, giving some guidance here. This year, we broke out from core operating expenses, which is really the classical R&D and SG&A, which we're targeting around $350 million for this year versus I put onetime expenses in quotes. It's a onetime series of expenses associated with the build-out of our inventory for subcu BRIUMVI and bringing on our secondary manufacturer. So those expenses are probably going to carry for 1 or 2 years. But once they get those -- whether the site is approved for the secondary manufacturer or subcu BRIUMVI is approved, all further production goes into inventory. And these dollars that came out of here will go to reduce our cost of goods. So they're not pure expenses. So I separate out, but all the numbers are there, so you could see them, and we'll probably keep this going for a year or 2, so you can see the core expenses, which I think is a critical component here. And if you look at assuming growth in revenues and core expenses definitely going to be increasing, but not at a crazy level. You could see just by looking at these numbers, we're going to have a significant amount of cash flow and EBITDA over the next several years. One thing we have talked about, we have opened, I think right now, we have $100 million of capacity under our repurchase plan, our stock repurchase plan. I think at these levels of stock price, we're more likely than not to increase the level of share repurchases, but that is yet to be determined. But just to give you a sense of where our heads are at. And then just to finish the session with some highlights, sort of summarize where we are. BRIUMVI continues to outperform expectations. Again, we started this year at about $525 million. I think the analysts were also there. We ended up closer to $600 million. Year-over-year growth has been strong. The commercial momentum continues to build. So very excited about how BRIUMVI is performing. And just to set the stage, the IV portion of this market alone represents a multibillion-dollar opportunity for BRIUMVI before we layer in the subcu, which has its own market and its own opportunity for us. And we also think that is a multibillion-dollar opportunity. Again, I think it's been underestimated the pipeline and a product potential for BRIUMVI. And I think subcu BRIUMVI will open the door and get people understanding the potential opportunity for us there. And then there's growth potentially with other molecules like azer-cel. Patents we didn't talk about that in today's session, but we have patents into the mid-2040s. We're expecting a -- we have an issued composition matter on the glycosylation of the molecule through 2042 or '43, and we're expecting a subcu formulation path through 2045. So really a long-term opportunity, again, to exploit multiple indications, really get BRIUMVI out there into new spaces. And then finally, sort of alluded to it, but we have significant operating leverage. Our OpEx maintains at probably one of the lowest levels of any company with our revenue base, and we see profitability accelerating. So with that, I will pause. I know I'm sure there's going to be some crazy questions. We should get to that.
Lut Ming Cheng
AnalystsCrazy. So let's start with the Q&A. For those who are in the audience, feel free to raise your hands. And for those who are joining us virtually, you can also submit questions on the portal. Mike, just to kick off here, as we think about 2026, do you see the dynamics being the same just on a quarter-to-quarter basis? And you have also laid out revenue guidance here. So it will be helpful if you can also layer in some thoughts about what went into this revenue guidance for the year ahead?
Michael Weiss
ExecutivesYes. So we have a forecasting team, like I said, they've been providing us these numbers. They use -- they have a prediction of how many patients are going to be newly enrolled in a given year. They have a prediction about how many patients are going to come back. They have prediction about gross to net for the year, and that all comes together. And then there's a few other -- those are probably the core, I would say, 3 inputs. I think there's 4 or 5 other major inputs that they work with but they plug it in, they come up with a matrix and they come out with the recommendation for us.
Lut Ming Cheng
AnalystsAnd any thoughts about just how we should think about quarter-to-quarter 2026, how does that compare to 2025? Is there any difference that you would expect? Or should we expect kind of a similar dynamics in terms of going from 1Q to 2Q? How should we think about 2026 versus 2025?
Michael Weiss
ExecutivesYes. In the absence of any new information, I'm going to have to say, yes, I would assume the same cadence as 2025.
Lut Ming Cheng
AnalystsOkay. And in your prepared remarks, you talk about you expect 10% to 20% sales force growth. Correct me, if I'm wrong. And just curious how we should think about how -- where are you placing those additional sales force. And have you identified any additional pocket of opportunities in the physicians who are taking care of these MS patients today?
Michael Weiss
ExecutivesYes. So you are correct. So it's about a 10% to 20%, give or take. I mean, this is not no precision that, but approximately another 10% to 20%. In the field force, we have a number of different field teams. So that is an aggregate number. But as I mentioned, we have a proprietary algorithm that identifies high potential targets for us. folks who ought to be using BRIUMVI and may not be using it as much as they should or not using it at all. And so we will build the field force around making sure that we can get to those folks with the right level of frequency.
Lut Ming Cheng
AnalystsAny questions from the audience?
Unknown Analyst
AnalystsI think you said the net revenues in the U.S. -- the figure for the net revenues in the U.S. was $594 million for last year, 20,000 patients in the U.S., so around 30,000. I don't know, if that's blended for your VA discount. But my question is about you made a point to say that when you were pricing in the go-to-market phase, you said, let's go into the low end and really establish a presence and work from their other ways to grow. What I'm curious about is I think you said the company was formed in 2012. So it was a 10-year journey to get it approved in '22? And along the way, you must have had other pricing assumptions. I'm curious how did that evolve over time? And how do they compare to the payer discussions, which is kind of the ultimate reality check on how you're going to get through the market.
Michael Weiss
ExecutivesYes. So I can't say that in 2012, we were thinking too much about the pricing considerations. But as we got closer to the market, of course, we had comparables out there. So there's an approved IV product that was priced. So really, at the end of the day, it was through conversations with payers about what would help get us coverage as quickly as possible. One of the things we felt was super important was making sure that if we spoke to a clinician, that they could write for it and their patient we covered. And I think we had 80%, 85% coverage within the first 6 months. So it really was a successful strategy and continues to be, I believe, a successful strategy. We have parity coverage almost everywhere, not everywhere, but almost everywhere. We have some priority status. They still carry some priority status. So I think net-net, it worked out -- the strategy worked out well. But yes, it was definitely a discussion with payers and understanding where we can make sure that we can clear the market and get coverage as quickly as possible.
Lut Ming Cheng
AnalystsThat came in at the -- obviously, at the end of the process, and it didn't require drastic retuning of your assumptions. It's more like some tweaking?
Michael Weiss
ExecutivesYes. Yes. I mean, again, like I said, before we launched within several years before we launched, there was a price out there for competitors. So I think within a range -- I mean, we did come in at about a 25% discount, but I don't think it impacted modeling of what we thought the opportunity was or was not.
Lut Ming Cheng
AnalystsJust within the CD20 class. What are you hearing from the ground on the demand for subcu versus IV. Over time, as studies say, how do you see the split of subcu versus IV?
Michael Weiss
ExecutivesYes, it's hard to say. We've -- for a little while, we felt like it was on a continual growth path, but it seems to have settled down. I think there were some quarters, where it was close to 40% but net-net, it seems to have settled down closer to 35% and seems to be relatively stable there. But yes, it is hard to say. I don't think there's a lose-lose I think there's a win-win situation for us. I mean we're going to -- if we are successful in developing both the subcu and having, of course, the IV, we'll participate in the growth of the overall sector and whether 1 arm grows better than the other arm. I guess we don't care at that point. As long as we're participating and getting our portion of market share -- like I said, we want to grow with the market because we think it's growing, and we want to grow within the CD20 class as we get to our goal of being the #1 prescribed medicine CD20.
Lut Ming Cheng
AnalystsIn terms of the subcu pricing, how much beyond the subcu be priced relative to where Kesimpta today?
Michael Weiss
ExecutivesYes. I mean, look, we will -- as with the IV, we're going to look at the marketplace, we're going to understand what makes sense. I mean we're definitely using on a milligram per milligram basis, we're using a lot more drug to make subcu. So even if you just charge on a milligram basis, it's going to be a higher price point for something like this. But between that and looking at Kesimpta, we'll have a sense of where we ought to be pricing this.
Lut Ming Cheng
AnalystsAny questions from the audience? Maybe just switching gears into the competitive dynamic here. How do you think about the BTK class as an emerging class from where you stand today? We could potentially get -- we will get PPMS data and ACTRIMS in a couple of weeks. What will you be looking for in that data set as from where you are -- where you stand today?
Michael Weiss
ExecutivesYes. I mean, look, on the primary progressive side, we're completely supportive of any new treatment that could help those patients. It's an area that is underserved. I don't -- I think the rub on being equivalent to ocrelizumab is that most clinicians don't really believe that it's doing all that much. It's approved which is great. I'm glad there's something that's approved for those patients. So when that PPMS data is actually shown in its fullest, I mean, we'll get some sensitivity around how equivalent it is or if it's -- it was -- I think it was stated it was at least numerically better, but certainly not statistically better. So I think it's going to be 1 of those situations where hard to say. But again, if you have no options, I think it's great for patients to at least try something hopefully, it won't be too toxic. Obviously, there's liver tox associated with those agents. There's generally not that 1 in particular. Just generally, BTKs have liver tox. They have cardiovascular issues. So there's pros and cons, and they do have their immune modulators. They have plenty of infections as well. It's not like you're going to get rid of CD20 infections by delivering a BTK, you're going to still see infection. So like to see the data. It's hard to say what kind of impact it will have. But hopefully, for those folks who will provide some value.
Unknown Analyst
AnalystsThank you for the time. I would love to know -- when you look at rest of the world, obviously, U.S. still makes up the majority of your revenue, but how is that large curve kind of looking? And when you talk about the 10% to 20% increase in sales force, are you really working on establishing more clinician relationships there? Or just speaking about that rest of the world opportunity.
Michael Weiss
ExecutivesYes. Thanks for that question. So the rest of the world, we have a partner, Neuraxpharm. So they do the heavy lifting there. So no, our 10% to 20% is purely a U.S. number where we do our commercialization. And I think the team at Neuraxpharm is doing a very nice job. I think their trajectory is going quite well. But we are a passive participant in the ex-U.S. launch and we get milestones, royalties. Yes, that's basically the royalties and milestones.
Lut Ming Cheng
AnalystsCan you talk a little bit about just what's ahead in terms of azer-cels in progressive MS. What is a win scenario for azer-cel? And how do you think about what you need before you move into the next step.
Michael Weiss
ExecutivesYes. So we picked probably the most challenging area to start with a CAR-T but that's okay. We're going to move into other. So I think safety, first and foremost, can we deliver the agent safely? Does it grow, expand and then hopefully disappear. And when it's in there, does it deplete B cells, there's some other biomarkers that we can look at. But safety is first and foremost for that agent and also for the study. Like I said, there's not a whole lot you're going to be able to hang your hat on. I mean I could tell you that the patients are feeling great, right? And they're telling us they feel better than they did before, and that's not going to be very useful information, to be honest, and people will say those things. But -- and there's not a lot you can do with someone who has progressive MS, you have to look at them longitudinally to get any real information. And you can't look at a small number of them to get that information because it's too variable. So yes, unfortunately, I think safety and getting to the right dose will be the goal for that study. Any indications that we can provide and give comfort. Well, of course, we will present those. But as we move into some of the other diseases, MG is one that has a really nice scale that you can use, that's relatively objective, but there is nothing like that for PPMS that would be meaningful.
Lut Ming Cheng
AnalystsGreat. Just to kind of wrap up our chat here. How do you frame 2026 for TG. If we have the same conversation at the end of this year, where do you think our conversation focus will be?
Michael Weiss
ExecutivesLook, left this slide up here for that particular reason. I didn't know you're going to ask that question, but yes, I mean, look, it's a big year for TG. We're going to be driving significant revenue. So BRIUMVI IV is going to continue to be the center stage. While we can deliver hopefully 2 pivotal data sets maybe get a -- or hopefully get a registration-directed study open in another indication outside of MS. And again, we'll see what -- maybe there's some exciting things that come in out from out of azer-cel. Again, you just never know when you're doing clinical trials, what you're going to see. So I think there's revenue growth and 2 pivotal data sets are probably defining 2026 for us.
Lut Ming Cheng
AnalystsWell, thank you so much for your time. Thank you.
Michael Weiss
ExecutivesThank you.
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For developers and AI pipelines
Programmatic access to TG Therapeutics, Inc. earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.