TG Therapeutics, Inc.

Greetings, and welcome to the TG Therapeutics fourth quarter and full year conference call and webcast. At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may press star one at any time to be placed in the question queue. We ask you to please ask one question and one follow-up, then return to the queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Communications Officer Jenna Bosco. Please go ahead.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and full year 2024 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercialization Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our corporate developments, Adam will share an update on our commercialization efforts, and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected milestones, revenue guidance, development plans, and expectations for our marketed product. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

Great. And thanks, Jenna. And thanks, everyone, for joining us this morning. I'm really excited to be able to host this call. just following the ATRIMS conference that was held last week. These meetings are really so energizing for me. They're great venues, not only to present and review data, but to interact with so many healthcare providers all in one place. And I have to say, by and large, the feedback on BrionV and the TG team was overwhelmingly positive. You don't know how gratifying it is to hear how our team can make a real impact on the patient experience. And even more gratifying is to hear the stories from health care providers of how Briomvi is impacting their patients, especially challenging ones. The anecdotes about patients who have challenging times on prior therapies and then followed by a positive experience on Briomvi is really why we do, I myself and everyone at TG, do what we do every day. So with that, I thought I'd turn to the business of today. 2024 was an exciting year for TG, marked by outperformance and growth across various aspects of our business. As noted at the JP Morgan Conference, our full-year 2024 U.S. revenues of $310 million far exceeded our target guidance heading into the year, which we believe is reflective of the value Bremery brings to those living with MS. The team made significant progress also during the year, launching and enrolling clinical trials to improve the patient experience on BrionV, which led to the presentation of several meaningful data sets during the course of 2024. And most recently, we updated our enhanced study at the Acton Conference. You may recall in 2024, we presented the first data emerging from the enhanced trial where we demonstrated the preliminary safety of a 30-minute maintenance infusion, as well as the feasibility of switching individuals from another anti-CD20 to BrionV without the need for the four-hour introductory dose. At Actrums, we updated the 30-minute cohort, showing consistent safety and tolerability profile as previously presented, now with over 80 patients treated with a 30-minute infusion. In addition to our company-sponsored studies presented at Actrums, Dr. John Foley from the Rocky Mountain Multiple Sclerosis Clinic presented the first ever real-world experience data from his practice from over 160 individuals with MS treated with BrionV. The results seemed to be consistent with the overall safety and tolerability of BrionV as seen on our ultimate one and two clinical trials. And interestingly, in a subset of patients previously treated with the Ocrevus who experienced a wearing-off effect between their Ocrevus infusions did not report this effect while on BrionV. In that subset, there were 19 patients and 16 of which, so 85%, did not experience the wearing off effect after switching to BrionV. Since this is an independent presentation of externally generated data, it is not included in our publications library. But I would encourage those who are interested to access the data through the Actron's website. Also during 2024, at the ACTRIMS conference in September, the ECTRIMS conference, so very distinguishable, one is the European, that starts with the E, and the ACTRIMS, which was last week, starts with an A. We presented the long-term follow-up data from the open-label extension study of the ultimate one and two phase three trials. The data showed after five years of BrionV treatment, 92% of patients were free from disability progression, and in the fifth year of treatment, an annualized relapse rate of 0.02 was observed. This is equivalent to one relapse occurring every 50 years of treatment. Additionally, the overall safety profile remained consistent over five years of continuous BrionV treatment with no new safety signals emerging with prolonged usage. With BrionV being the newest entrant into the CD20 landscape, We believe this data was important to many ACPs and individuals with MS. I also wanted to share some clinical progress, which we made during the year as well. For these studies, we haven't yet presented the data. Late in 2024, we started a new cohort to enhance study that combined the starting dose, which is 150 milligrams given over four hours, and the first maintenance dose, which is 450 milligrams given in one hour, two weeks later, and we combine that into one single 600 milligram infusion, which effectively eliminates the need to get two infusions in the first two weeks of starting BreonV. While we haven't presented data from this cohort yet, from the data we have seen in over 50 patients, we felt confident that this approach is achievable in a four-hour infusion, which is the same timeframe as our currently approved starting dose. We look forward to launching one or more pivotal trials this year with the goal of potentially incorporating all or some of the updates explored in the hand study into the IV BrionV label as soon as possible. Another key effort for us is developing and commercializing a subcutaneous formulation of BrionV. As we've discussed in the past, currently the majority of MS patients starting on anti-CD20 will choose an IV delivered every six months. And the remainder, nearly 40%, are now choosing to self-administer a sub-Q at home. With almost 40% of new starts going on a self-administered sub-Q, we believe sub-Q-Briumvi would represent a meaningful expansion opportunity for TG. And most recently, at the J.P. Morgan Conference, we were pleased to share that we believe the preliminary data from our bioavailability studies support at least every other month dosing for sub-Q-Briumvi. The currently self-administered sub-Q is taken once per month, so if we are successful, we could cut the number of injections per year in half. This is an exciting development for us, and we look forward to commencing a pivotal trial around the middle of the year and providing additional information on this program later this year. Beyond Breon V in MS, I'm pleased to announce that we've started treating individuals with myasthenia gravis, or MG, in exploratory study. We think MG is a good place for us to begin to explore BrionV outside of MS and look forward to hopefully sharing some data later this year. We also plan to continue to evaluate other areas outside of MS where we believe BrionV may offer a meaningful treatment option for patients. And beyond BrionV altogether, on the pipeline front, We were pleased to have announced in 2024 that we entered into a partnership with Precision Biosciences to acquire a worldwide license to develop Azercel for autoimmune diseases. As an allogeneic, which means basically can be given off the shelf, CD19 CAR T-cell therapy, we believe Azercel has the potential to be first in class, best in class treatment for certain autoimmune diseases. Having said that, we believe there will be multiple winners in what we see as an extremely large market addressing a significant number of autoimmune diseases with CAR-T's. We were pleased to receive IND clearance for a phase one study, evaluating Azor cell and progressive forms of multiple sclerosis. And we look forward to enrolling our first patients into the phase one study, hopefully very soon. As you can see, we made a lot of progress on all fronts in 2024, and we plan to carry that momentum into 2025. One last but very important item I wanted to note. During 2024, we were incredibly pleased to have three new patents issued by the U.S. Patent and Trademark Office, providing patent protection for Breon V through 2042, which included a composition of matter covering the glycoengineered attributes of Breon V. In summary, 2024 was a year of continued strong execution by the TG team. including above-expectations revenues for BRIOMV, expansion of the BRIOMV patent portfolio with composition and matter patent protection now through 2042, the launch of BRIOMV outside the U.S. with our partners NurexPharm, the presentation of important data, including five-year follow-up data from the ultimate one and two trials, and data from the enhanced trial, which we plan to use to support the launch of additional pivotal trials in 2025, and we also made significant progress with our clinical programs, including preliminary bioavailability of subcutaneous BrionV. We treated individuals with MG with BrionV, and we opened our phase one evaluating azure cell in progressive forms of MS. With that, let me hand the call over to Adam Waldman to write a more detailed review of the BrionV US launch in 2024, our early performance in 2025, and our plans for the rest of the year. Adam?

Thanks, Mike, and good morning, everyone. We are pleased to report another quarter of strong commercial performance, marking continued momentum as we closed out 2024. Despite a new competitive entrant, we delivered significant quarter-over-quarter growth, reinforcing our confidence in Briomby's positioning and long-term potential in the relapsing MS market. As reported at the JPMorgan conference in January, Fourth quarter U.S. net sales for Brionvi were $103.6 million, representing 24% growth quarter over quarter and 160% growth versus same quarter last year. That brought our full year 2024 revenues to $310 million, approximately 250% growth versus 2023. The fourth quarter numbers and full year numbers exceeded our guidance and reflect the growing demand we are seeing for Brionvi. Briambi is also gaining momentum internationally. As many of you know, we partnered ex-North America commercialization rights to Nurax Farm, who launched Briambi in Germany in February of 2024. Since then, they have launched in a number of EU countries and the UK. And overall, the feedback from the EU has been positive, and we look forward to them continuing to expand the geographical reach of Briambi in the future. Our differentiation strategy remains strong. The confidence that physicians have demonstrated in continuing to prescribe BrionV underscores its importance in the adult RMS treatment paradigm. Our recent five-year data and real-world experience continue to reinforce the unique value proposition of BrionV, an efficient infusion combined with a proven efficacy and a consistent safety profile. The quarter-over-quarter growth we achieved validates the increasing confidence among prescribers and patients in Breon B as a leading anti-CD20 option in our MS. Our dynamic market share in the physician-administered anti-CD20 segment is increasing, and we anticipate continued growth as physician experience and comfort with Breon B increases. Additionally, our field teams have been highly effective in educating prescribers on the attributes of Breon B. with increasing adoption among high-volume infusion centers and academic neurologists. We remain committed to expanding patient education efforts and optimizing the overall treatment experience. The foundational work we have done throughout 2024, coupled with the strong adoption trends we are seeing today, set the stage for continued growth in 2025. We will maintain our focus on driving deeper penetration in the RMS market, ensuring that Briambi reaches as many eligible patients as possible. Looking ahead to 2025, we expect multiple drivers to continue fueling our growth, including expansion into additional infusion centers, academic and community practices, direct-to-patient engagement efforts, increased real-world evidence supporting Breonvy's efficacy, safety, and tolerability, and strengthening perceptions around payer coverage and access. We are off to a strong start in 2025. Despite the typical challenges inherent in Q1, enrollments and overall demand have been robust, with January and February being our highest month of total new patients into our hub since launch. We feel confident in how the year has started and are now estimating $115 million in U.S. pre-MV net revenue in Q1 and believe we are on track to meet or exceed our full-year U.S. guidance of $525 million. In closing, I want to thank our dedicated team for the relentless efforts in bringing Briambi to people with RMS. Over the past two years, we have built a strong foundational commercial infrastructure that has delivered exceptional results, exceeding all expectations for the launch. This success now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. We have the team, we have the capabilities, and the leverage to drive future growth. including the opportunity to further strengthen our position in the RMS market with enhanced IV administration options and the development of a patient-administered subcutaneous formulation of Briambi. We believe this new option has the potential to significantly expand our market opportunity, allowing us to compete more broadly across the RMS space with potentially best-in-class products in both the IV and subcutaneous markets. These advancements will help drive sustained growth for years to come. We remain very excited about the future and look forward to updating you on the progress in the quarters ahead. With that, I'll turn it over to Sean to discuss our financials.

Thank you. Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed fourth quarter and full year 2024 financial results in a press release, which is available on the Investors and Media section of our website. This morning, I'll start with a discussion of our revenue for the fourth quarter and full year of 2024, which Adam had briefly touched on. We are pleased to report U.S. pre-MV net product revenue of $103.6 million during the fourth quarter. Our total net product revenue for the fourth quarter was $107.3 million, and in addition to U.S. net revenue includes approximately $3.7 million of revenue for products sold to Neuro X Farm in support of the ex-US commercial launch. For the full year, we reported total global revenue of approximately $329 million, which is predominantly comprised of $310 million in U.S. Breon B net product sales and a $12.5 million milestone from our partner for the ex-US commercial launch of Breon B. As mentioned a moment ago, during the quarter, we recognized revenue for products sold to our partner, Nerox Farm. It is worth noting that when looking at our COGS margin in the fourth quarter, it includes the cost of goods sold to our partner, which are of course sold at a margin significantly less than what we see commercially here in the U.S., thereby giving the appearance of having an unfavorable impact on our gross margin. Absent this infrequent occurrence, When we recognize revenue related to the sale of goods to our partner, our gross margin has and should remain relatively consistent. On the expense side of the ledger, we commenced the year with 2024 OpEx guidance excluding non-cash items of approximately $250 million. And we're pleased to report that during the quarter and full year 2024, our operating expenses have remained well-controlled and below our guided ranges. For the fourth quarter and full year 2024, our OPEX was approximately $51 million and $206 million, respectively. Earlier this year at the JPMorgan conference, we guided that we expect our operating expenses to be approximately $300 million for the full year 2025. As a result of the continued strong pre-MV launch and a strategic and disciplined approach to spending, we are pleased to report GAAP net income of approximately 23 million or 15 cents per diluted share in both the three and 12-month periods ending December 31st, 2024. And last but not least, I'll close by touching on our cash position. We ended the fourth quarter with approximately $311 million in cash, cash equivalents, and investment securities. When excluding investments in inventory and share repurchases, we generated cash flow from operations in 2024, a trend which we expect to continue in 2025. We believe our existing cash provides us with a strong financial position to continue to support the Briandi commercialization and invest in our research and development efforts and our business operations for the foreseeable future. With that, I will now turn the call back over to the conference operator to begin the Q&A.

Thank you, and I'll be conducting a question and answer session. If you'd like to be placed into question queue, please press star one on your telephone keypad. As a reminder, we ask that you please ask one question and one follow-up, then return to the queue. If you'd like to remove your question from the queue, please press star two. Once again, that's star one to be placed in the question queue. Our first question is coming from Prakhar Arvawal from Canada. Prince Charles, your line is now live.

Hi, good morning and thank you for taking my questions and congrats on all the progress. So maybe firstly, you mentioned about January and February being a strong growth and 2025 guide to meaningfully exceed the 525 million that you gave. So maybe just give more color on that. what you're seeing, what are the biggest segments of growth as you look towards the rest of the year. And secondly, Okros has a high-dose readout this year. Maybe if you can talk about where you see that product playing a role in the market, that would be super helpful. Thank you.

Mike, do you want me to take that?

Your after phone is on mute.

Yeah, sorry about that. Yeah, go ahead, Adam, why don't you go ahead.

Yeah, Prakash, thanks for the question. Our growth, talk to the first question about the growth. Our growth comes from, you know, it's coming from a broad set of customers with enrollment so far in both, you know, the academic and private clinic setting. A little bit more in academic now, as I mentioned, I think, in previous calls. Academic hospitals now account for the majority of where we're seeing growth in our overall enrollments. You know, I think that's being driven by a lot of things. The number of things that we talked about in the call, the five-year data, the real-world experience, our expansion strategy, of course, with more people in the field versus we did a pretty significant expansion in 2024. So all those things are driving our growth that we're seeing. And as I said, January and February were our best months in terms of new enrollments into our hub. And then for the high dose, I'll start and I'll hand it over to Mike. It really depends on the profile. I mean, we haven't seen much in terms of what the profile looks like, what the safety profile will look like, what the infusion experience. So really hard to comment until we know more.

Yeah, I'll just add to that. I think that's a fair point. We have very little to go on for the moment. We imagine it will be a relatively long infusion. I assume they'll figure out, they'll try to put it into some sort of sub-Q to try to limit the timeframe, but the volume will be pretty dramatic. So yeah, until we know more, I think we just have to wait and see.

Thank you. Next question today is coming from Michael D. Fiore from Evercore ISI. Your line is now live.

Hi, guys. Thanks for taking my call. Congrats on all the progress. Two for me. Obviously, it seems like the pivotal phase three subcutaneous trial for Brionne may come around the middle of the year. To the extent that you can, I mean, has the sub-Q trial design been finalized, and can you confirm whether Q2 months or Q3 months remains the target regimen? And finally, just a follow-up, the expectations on gross to net for the balance of the year. Thank you.

Adam, why don't you go ahead and do the gross to net, and I'll come back and do the sub-Q.

Yeah. Yeah, Michael, we expect gross to net in the 70% to 75% range with some fluctuations quarter to quarter, but that's what we're expecting.

Okay. Okay. And the sub-Q, yeah, so the target is to get this going hopefully by the middle of the year. In terms of the exact design, it has not been finalized. We're still gathering more. We're still looking at the study design in terms of whether it's going to be every two months or every three months. I think that's still yet to be determined, and it is plausible that we could end up with – with potentially studying two doses in the phase three.

Got it. Thanks so much.

You got it.

Thank you. Next question is coming from Ed White from HC Wayne. Your line is now live.

Great. Thanks for taking my question. So just a follow-up question on the sub-Q potential. How are you thinking about the size of that trial And the timing for enrollment, seeing as that it's, you know, a competitive market that's already penetrated.

Yeah, thanks for the question. So the size of the trial is most likely going to be similar to the studies that Okravis did for their sub-Q. I think we're talking about, you know, somewhere around 200 per arm, probably a little bit less. trying to remember exactly what they were. Maybe they're like 150 per arm. So it's not an incredibly large study. It's not a small study either. But in terms of enrollment, I mean, we enrolled in the pivotal studies for Breon V, a thousand patients in 12 months or so. So I don't know that enrollment is going to be the challenge here. I just think we just got to get ourselves in a position to get it going. But Yeah, we're projecting about a 12-month enrollment period. Could be a little longer, could be a little shorter, but give or take about a year. Yep. You got it.

Okay. Thanks. And then just, you know, I appreciate the OPEX guidance. How should we be thinking about that regarding SD&A versus R&D? The question on SG&A is just is the Salesforce right size now or continue to add there? And are there any marketing schemes going forward that might lead to increased SG&A costs?

Adam, you want to go ahead?

Yeah, sure. Thanks, Ed. So on the Salesforce side, I think we'll look to strategically continue to add people slowly over time where we see opportunity. So I think there could be, but I don't think those would be material expansions to SG&A. And then we do expect to do some patient, as we said in the past, and we said this morning, we'll be doing some things on the patient side, but I'll let Sean or Mike comment to the materiality of that.

Yeah, I don't have any further comments.

Sean, do you on that? No, nothing further at this time. Okay.

Ed, just a quick, my crack staff was ready to go with a better answer than mine. So I will tell you that we're probably looking at somewhere about 125 to 150 per arm, which is in line with the Oprah sub-Q study for the sub-Q arms.

Okay, great. Thanks, Mike. Thanks for taking my questions.

Yep, thank you.

Thank you. Next question is coming from Eric Gilson from J.P. Morgan. Your line is now live.

Hi, good morning. Thanks for taking the questions. Just on your feedback at ACTRIMS, I'm wondering what the reception has been like to the enhanced trial data to the extent, you know, docs are apt to modify use today based on the data that it's seeing so far and And how much more would a formal label expansion drive utilization based on the feedback you're getting so far? And then, I guess, looking to that end, I guess, when all said and done, would you expect to file an SBLA for a consolidated, shortened, enhanced infusion regimen? Yeah, sure.

Thanks. Thanks, Eric. Yeah, so we actually did do some polling while we were there, asked a number of folks about that. What's interesting is, if you recall, when we started the enhanced study for the Ocrevus switches, we did it because, in large part, because we had seen in the market that people were already taking folks on another CD20 and switching them to Brionvy without going through the introductory dose. To be honest, we had no experience with that whatsoever, and we really wanted to make sure there was safety information around that in case we needed to give any further guidance to folks. So we got that going rather quickly, and we were able to enroll, obviously, a significant number of patients. And what we've seen is that switching the patients without the 150 milligram dose doesn't appear to cause any safety concerns. So that was our biggest worry was safety of folks that were already in the field doing it. We did ask people about that, and most people that we had spoken to are already switching without using the first introductory dose again. So that's out of our hands. Obviously, we certainly don't talk about that in terms of commercially talking about it, but we did ask that question. So that one seems to be something that the community seems very comfortable with. I'd say the other stuff that we're working on, including 30-minute infusion, less likely that people will use a 30-minute infusion until there's proper instructions in the label. So that's something we'll be working on as well. And then in terms of the front end consolidating the two doses into one dose that we give on day one and we avoid having to come back, that's something I think we can get started on rather quickly. We hope to have... a BLA, potentially a PDUFA date for something like that by mid-27. So we'll keep you posted. But yeah, I think that's probably the one that could happen the fastest, second to the 30-minute. And we've stated previously that a full efficacy trial would be required to remove that switch dose. But for the moment, I think we feel comfortable with providing safety information through medical, but I don't know that that's going to go into a pivotal trial at this time.

Okay, great. Maybe one follow-up, if I could, just thinking about the myasthenia gravis expansion opportunity. I guess when you talk to neurologists, how are they thinking about sort of how broadly an ATCD20 approach might be adopted, particularly in relation to the the anti-C5 and FCRM blockers? Yeah.

I mean, like I said previously, I mean, we are exploring MG. It was one that we've had on our list for a while. It's not as underserved as it used to be. But we do think there's room potentially for a highly active, convenient, safe treatment option that, you know, could be potentially provided in a cost effective way. I mean, right now the treatments for MG are, you know, all on the highest, highest scale of, of, of expenses. And, you know, we know Brionv is, is quite cost effective in, in, uh, in how we've priced it. So I think there's, I think there's room in, in MG. Again, we've, we've said previously, we're not yet ready to, to, uh, to plant a flag and say MG is, is our next, development program, but we do think it's interesting. We're just, we're doing a lot more work on it and we'll be doing so all across this year as we look for other opportunities. We do think there's, we do think, you know, the CD19 slash CD20 opportunity across autoimmune diseases is large and whether it's with something like Briamvi or there's some opportunity, of course, with CAR T across multiple different autoimmune diseases. So I think there's, There's general enthusiasm. I think there's general belief that these work. I mean, they're all, you know, between, I won't speak much to the complement side of it, but certainly between the CD19, CD20 landscape and the FCRN, I mean, you are working along a certain part of the continuum of, you know, B cell to plasma to antibody diffusion strategies. So they're all similarly aligned in ways and just where in that cascade you think you're going to have the best effect and the best long-lasting effect.

Great. Thanks for taking the questions. You got it.

Thank you. Next question is coming from Mayank Mantami from B-Rally Securities. Your line is now live.

Yes. Good morning, team. Thanks for taking our questions and congrats on a great start to 2025. Are you able to share the revenue split of new to BMV versus maintenance patient segment? And just wondering, looking forward, has there been a change to an internal assumption when maintenance segment revenues exceed to that of new patients? And just a two-part question here. On a dynamic market share basis, are you able to comment on where you stand based on how you look at switch from another DMT or CD20 therapy.

Adam, you want to go ahead and give a crack and if I can add on top if necessary?

Yeah, yeah, sure. Thanks for the question, Mike. As far as the revenue splits, I don't have that for you. I think what I've said in the past is that early in 2025, we will start to see repeat prescriptions be the majority of the prescriptions that is forecasted to happen in the early part of 2025. That's our expectation. I can provide more detail on that in the future. And then as far as the dynamic market share, I think we said this at J.P. Morgan, we're getting about one in four patients on IV CD20 today, which represents about 60% of the market. But that number is increasing, and certainly we expect that to increase throughout the year.

Great. And just on the pipeline front, if you're able to give us some color on the size of the allogeneic CD20 study that you're starting enrollment shortly here and kind of what would be the timelines and maybe study objectives. I understand this would be dose finding initially, but any pharmacodynamic data that we could expect would be helpful to get some color, Mike. Thanks for taking our question.

Yeah, sure. So, um, that study is, uh, ready to launch. We're ready to receive patients. Um, this study is not yet enrolled its first patient. So, uh, I'd like to say we're going to have lots and lots of patients, but, uh, but so, so far a bit of a slow start, uh, out of the gate here. Uh, you know, the goal, as you mentioned is, uh, is dose finding. So first step is, is finding the right dose. finding the right conditioning regimen that makes the most sense in these patients and in this setting. So we've got a little bit of work to do there. And in terms of outcomes for patients with progressive forms of MS, I mean, the ultimate goal is you slow or stop the progression. Unfortunately, that's not something that you will be able to see easily with a handful of patients. So I don't think we're in this for some sort of miracle data that we give the CAR-T to a person with aggressive forms of MS and all of a sudden you can see some dramatic effect. Hopefully we'll be able to slow or stop that progression, which would be fantastic. There are biomarkers that could be looked at. There's some CNS biomarkers, all the clonal bands would be interesting. Certainly we'll look at B-cell depletion and repletion. So it's Some of these biomarkers are out there. We can look at those, but I think at some point we'd have to just get enough conviction to move forward with a randomized, which is the only way for progressive forms of MS. Having said that, we're also looking to expand into other disease states, which I'd call adjacent or ancillary to MS and things we think we could do well to get started. And then we can think about further expansion of that opportunity. But I'd prefer probably at this point to start slow and let's do some dose finding and let's make sure we can have a safe product that at least depletes B cells effectively in folks with autoimmune diseases.

Great. Very helpful. Thank you, Mike. Thanks, Mayank. Appreciate it.

Thank you. We reach the end of our question and answer session. I'd like to turn the floor back over to Mike for any further closing comments.

Great. Thank you. And thanks again, everyone, for joining today's call. We've been incredibly pleased with the progress made in 24. And, of course, looking forward to an exciting 25. I think you heard some really exciting developments, both on the commercial front and the early enrollments that we're seeing have given us a really nice feel for the year. You know, just to restate some primary goals for us, commencing pivotal programs for SubQ-Briumvi, commencing one or more pivotal studies to enhance the overall patient experience with BrionV, enrolling participants into the ongoing trials for BrionV and myasthenia gravis, enrolling, hopefully, as we discussed in this last question, our first patients into the phase one azure cell study, and we'll continue to make presentations during the course of the year, and as Adam described in great detail, really, you know, continue to push hard to bring BrionV as far and as wide as we can into the patient community in the U.S. and our partners ex-U.S. So with that, again, I'll just thank everyone for joining us, and have a great day.

Thank you. That does conclude today's teleconference and webcast, and we disconnect your line at this time, and have a wonderful day. We thank you for your participation today.