TGTX - NASDAQ

Greetings, and welcome to the TG Therapeutics' Fourth Quarter and Full Year Conference Call and Webcast. At this time, all participants are in a listen-only mode. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions] 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 products. 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 ACTRIMS 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 BRIUMVI 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 healthcare providers, of how BRIUMVI 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 BRIUMVI, 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 JPMorgan 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 BRIUMVI 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 BRIUMVI, which led to the presentation of several meaningful data sets, during the course of 2024, and most recently we updated our ENHANCE study, at the ACTRIMS Conference. You May recall in 2024, we presented the first data emerging from the ENHANCE 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 BRIUMVI without the need, for the four-hour introductory dose. At ACTRIMS, we updated the 30-minute cohort showing a 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 ACTRIMS, 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 BRIUMVI. The results seem to be consistent, with the overall safety and tolerability of BRIUMVI as seen in our ULTIMATE I and II clinical trials and interestingly, in a subset of patients previously treated with Ocrevus, who experienced a wearing off effect between their Ocrevus infusions did not report this effect while on BRIUMVI. In that subset, there were 19 patients and 16 of, which so 85% did not experience the wearing off effect, after switching to BRIUMVI. 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 ACTRIMS website. Also during 2024, at the ACTRIMS conference in September, the ACTRIMS 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 1 and 2 Phase 3 trials. The data showed after five years of BRIUMVI 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 BRIUMVI treatment, with no new safety signals emerging with prolonged usage. With BRIUMVI 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. Some of this 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 BRIUMVI. While we haven't presented data from this cohort yet, from the data we have seen in over 50 patients, we feel confident that this approach is achievable in a four-hour infusion, which is the same time frame 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 exploring the ENHANCE study, into the IV BRIUMVI label as soon as possible. Another key effort for us, is developing and commercializing a subcutaneous formulation of BRIUMVI. 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 subcu at home. With almost 40% of new starts going on a self-administered subcu, we believe subcu BRIUMVI, would represent a meaningful expansion opportunity for TG, and most recently at the JPMorgan Conference. We were pleased to share that, we believe the preliminary data from our bioavailability studies, support at least every other month dosing for subcu BRIUMVI. The currently self-administered Subcu 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 BRIUMVI in MS, I'm pleased to announce that, we've started treating individuals with Myasthenia Gravis or MG in the exploratory study. We think MG, is a good place for us to begin, to explore BRIUMVI 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 BRIUMVI may offer a meaningful treatment option for patients. And beyond BRIUMVI 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 azer-cel for autoimmune diseases, as an allogeneic, which means basically can be given off the shelf CD19 CAR T cell therapy. We believe azer-cel 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, what we see as an extremely large market, addressing a significant number of autoimmune diseases, with CAR-Ts. We are pleased to receive IND clearance, for a Phase 1 study evaluating azer-cel, and progressive forms of multiple sclerosis, and we look forward to enrolling our first patients into the Phase 1 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 BRIUMVI through 2042, which included a composition of matter covering the glyco engineered attributes of BRIUMVI. In summary, 2024 was a year of continued strong execution by the TG team, including above expectations revenues for BRIUMVI, expansion of the BRIUMVI patent portfolio, with composition of matter patent protection now through 2042, the launch of BRIUMVI outside the U.S. with our partners Neuraxpharm, the presentation of important data including five-year follow-up data from the ULTIMATE I and II trials, and data from the ENHANCE 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 BRIUMVI. We treated individuals with MG with BRIUMVI, and we opened our Phase 1 evaluating azer-cel in progressive forms of MS. With that, let me hand the call over to Adam Waldman, to provide a more detailed review of the BRIUMVI U.S. launch in 2024, our early performance in '25, 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 BRIUMVI'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 BRIUMVI were $103.6 million representing 24% growth, quarter-over-quarter, and 160% growth versus the 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 BRIUMVI. BRIUMVI is also gaining momentum internationally. As many of you know, we partnered ex North America commercialization rights to Neuraxpharm, who launched BRIUMVI in Germany in February of 2024. Since then, they have launched in a number of EU countries and the U.K., and overall the feedback from the EU has been positive, and we look forward to them continuing to expand the geographical reach of BRIUMVI in the future. Our differentiation strategy remains strong. The confidence physicians have demonstrated in continuing to prescribe BRIUMVI 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 BRIUMVI. 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 BRIUMVI as a leading anti-CD20 option in RMS. Our dynamic market share in the physician administered anti-CD20 segment, is increasing and we anticipate continued growth, as physician experience and comfort with BRIUMVI increases. Additionally, our field teams have been highly effective in educating prescribers on the attributes of BRIUMVI. 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 BRIUMVI 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 BRIUMVI'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. BRIUMVI 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 BRIUMVI 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 ENHANCE IV administration options, and the development of a patient administered subcutaneous formulation of BRIUMVI. 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 2024, which Adam had briefly touched on. We are pleased to report, U.S. BRIUMVI 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 Neuraxpharm in support of the ex U.S. 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. BRIUMVI net product sales, and a $12.5 million milestone from our partner for the ex U.S. commercial launch of BRIUMVI. As mentioned a moment ago, during the quarter we recognized revenue, for products sold to our partner Neuraxpharm. 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 BRIUMVI launch, and a strategic and disciplined approach to spending, we are pleased to report GAAP net income of approximately $23 million, or $0.15 per diluted share, in both the three and twelve-month periods ending December 31, 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 BRIUMVI 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. [Operator Instructions] Our first question is coming from Prakhar Agrawal from Cantor Fitzgerald. 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 strong growth, and 2025 guide to meaningfully exceed the $525 million that you gave. So maybe just give more color around that, what you're seeing. What are the biggest segments of growth, as you look towards the rest of the year? And secondly, Ocrevus 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, you want me to take that.

Perhaps the phone is on mute.

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

Yes, Prakhar, thanks for the question. Our growth - talk to the first question about the growth. Our growth comes from, it's coming from a broad set of customers, with enrollment so far in both, 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. 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 don't know, 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.

Yes, I'll just add to that. I think that's a fair claim. And 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 into, some sort of subcu to try to limit the timeframe, but the volume will be pretty dramatic. So, yes, until we know more, I think we just have to wait and see.

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

Hi, guys. Thanks for taking my call and congrats on all the progress, two from me. Obviously it seems like the pivotal Phase 3 subcutaneous trial for BRIUMVI may come around the middle of the year, to the extent that you can. I mean, has the subcu 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, I'll come back and do the subcu.

Yes, yes, Mike. We expect gross to net in the 70% to 75% range with some fluctuations quarter-to-quarter, but that's what we're expecting.

And the subcu, yes. So the target is to get this going hopefully by 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 potentially studying two doses in the Phase 3.

Got it. Thanks so much.

You got it.

Thank you. Next question is coming from Ed White from H.C. Wainwright. Your line is now live.

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

Yes, thanks Ed, for the question. So the size of the trial is most likely going to be similar to the studies that Ocrevus did for their subcu. I think we're talking about 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 BRIUMVI 1,000 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 yes, we're projecting about a 12-month enrollment period. It could be - Could be one, it could be a little shorter, but give or take, about a year. Yes. Yes, you got it. Okay.

Thanks. And then just, I appreciate the OpEx guidance. How should we be thinking about that regarding SG&A versus R&D, the question on SG&A is just is the sales force 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.

Yes, sure. Thanks, Ed. So on the sales force, 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 the 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.

Yes, I don't have any further comments. Sean, do you -- on that?

No, nothing further at this time.

Ed, just to click 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 Ocrevus subcu study for the subcu arms.

Okay. Great. Thanks Mike. Thanks for taking my questions.

Yes, thank you.

Thank you. Next question is coming from Eric Joseph from JPMorgan. 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 ENHANCE, the ENHANCE trial data, the extent that docs are apt to modify use today based on the data that you're seeing so far. 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, ENHANCE infusion regimen with BRIUMVI?

Yes, sure. Thanks. Thanks, Eric. Yes, so we actually did do some polling while we're there, asked a number of folks about that. What's interesting is if you recall, when we started the ENHANCE 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 BRIUMVI without going through the introductory dose. And 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 concern. 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, that's out of our hands. Obviously we don't, 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 get started on rather quickly. We hope to have BLA potentially a PDUFA day for something like that by mid '27. So we'll keep you posted. But yes, I think that's probably the one that could happen. The fastest second would be 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 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 real thinking about sort of how broadly an anti-CD20 approach might be adopted, particularly in relation to the anti-C5 and FcRn blockers?

Yes. 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 highly active, convenient, safe treatment option that could be potentially provided in a cost-effective way. I mean right now, the treatments for MG are all on the highest scale of expenses. And we know BRIUMVI is quite cost effective in how we've priced it. So I think there's room in MG. Again, we've said previously we're not yet ready to plan to flag and say, MG 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 across this year. As we look for other opportunities, we do think the CD19/CD20 opportunity across autoimmune diseases as large and whether it's with something like BRIUMVI, or is there some opportunity, of course, with CAR-T across multiple different autoimmune diseases. So I think there's general enthusiasm. I think there's general belief that these work. I mean, they're all between - I won't speak much to the complement side of it. But certainly, between the CD19, CD20 landscape in the FcRn, I mean you are working along a certain part of the continuum of B-cell to plasma, to antibody to do some strategies. So they're all similarly aligned in ways, and just where in that cascade do 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 Mamtani from B. Riley 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 BRIUMVI versus maintenance, patient segment? And just wondering, looking forward, has there been a change to an internal assumption when maintenance segment revenues exceed that of new patients? And just a two-part question here. On a dynamic market share basis, are you able to comment on what - 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.

Yes. Yes, sure. Thanks for the question, Mike. As far as the revenue split, 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 JPMorgan, we're getting about one in four - on 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 in enrollment shortly here, and kind of what would be the time lines, and maybe steady objectives? I understand this would be dose-finding initially, but any pharmacodynamic data that we could expect it would be helpful to get some color, Mike? Thanks for taking my questions.

Yes, sure. So that study is ready to launch. We're ready to receive patients. This study is not yet enrolled its first patient. So I'd like to say we're going to have lots and lots of patients plan, but so far, a bit of a slow start out of the gate here. The goal as you mentioned, is dose finding. So first step is finding, the right dose finding the right conditioning regimen that, makes the most sense in these patients and in the 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 as you slow or stop the progression, unfortunately, that's not a - it'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 it the CAR-T to - first in with aggressive forms of MS. And all of a sudden, you could 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, Oligoclonal 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 the randomized, which is the only way for primary forms of 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 reached the end of our question-and-answer session. I'd like to turn the floor back over to Mike, for any further or 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. Just to restate some primary goals, for us commencing pivotal program for subcu, BRIUMVI commencing one or more pivotal studies, to enhance the overall patient experience with BRIUMVI, enrolling participants into the ongoing trials for BRIUMVI and myasthenia gravis. Enrolling hopefully, as we discussed in this last question, our first patients into the Phase 1 azer-cel study. And we'll continue, to make presentations during the course of the year. And as Adam described in great detail, really continue to push hard to bring BRIUMVI 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.