TG Therapeutics - Earnings Call - Q4 2024

Executive Summary

• Q4 delivered record revenue and profitability: product revenue, net rose to $107.3M (U.S. BRIUMVI $103.6M), total revenue $108.2M, GAAP diluted EPS $0.15, and net income $23.3M, driven by continued U.S. BRIUMVI adoption and initial ex-U.S. shipments to partner Neuraxpharm.
• Management introduced 2025 guidance targeting ~$540M total global revenue (U.S. BRIUMVI ~$525M) and OpEx of ~$300M (ex‑non‑cash), and guided Q1 2025 U.S. BRIUMVI net revenue of ~$115M, underscoring confidence in growth trajectory.
• Sequential operating momentum continued (Q2→Q3→Q4 product revenue: $72.6M → $83.3M → $107.3M); gross margin optics in Q4 were modestly impacted by lower‑margin partner shipments embedded in COGS, but underlying U.S. margin consistency was reiterated.
• Strategic milestones de‑risk the outlook: three U.S. patents extend BRIUMVI protection through 2042; subcutaneous (SC) formulation and IV administration enhancements (30‑minute maintenance infusion; consolidated day‑1 dosing) advance toward pivotal programs; EU/UK launch progressed via Neuraxpharm.

What Went Well and What Went Wrong

What Went Well

• Robust commercial execution: U.S. BRIUMVI net sales reached $103.6M in Q4 (24% QoQ), driving total product revenue, net to $107.3M and GAAP diluted EPS to $0.15.
• Positive early 2025 read‑through and raised bar: management called out record Jan/Feb enrollments in the hub and guided ~$115M U.S. BRIUMVI net revenue for Q1 2025; full‑year 2025 targets set at ~$540M global/~$525M U.S..
• Strategic and clinical differentiation: five‑year ULTIMATE data show 92% free of disability progression and ARR 0.02 in year 5; ENHANCE shows feasibility of 30‑minute maintenance infusion and direct switching from other anti‑CD20s without the 150 mg load (97% infusions completed without slowing); CEO: “2024 was a year of significant outperformance and growth… strong adoption of BRIUMVI… strengthening our BRIUMVI patent portfolio through 2042”.

What Went Wrong

• Gross margin optics in Q4: CFO noted cost of goods included lower‑margin ex‑U.S. partner shipments (~$3.7M revenue), creating the appearance of an unfavorable gross margin impact in the quarter vs U.S. commercial sales; underlying gross margin otherwise consistent.
• Elevated interest expense YoY: interest expense was $7.1M in Q4 2024 vs $2.4M in Q4 2023 following the $250M credit facility, though partly offset by higher operating income.
• Consensus estimates: S&P Global consensus for Q4 and near‑term periods was unavailable at time of analysis due to SPGI request limits, limiting beat/miss benchmarking (see Estimates Context).

Transcript

Operator (participant)

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 and 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.

Jenna Bosco (Chief Communications Officer)

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.

Michael Weiss (Chairman and 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 J.P. 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 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.

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 seemed to be consistent with the overall safety and tolerability of BRIUMVI as seen in our ULTIMATE I and II clinical trials.

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. 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 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 I and II phase III 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 HCPs 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 the ENHANCE study that combined the starting dose, which is 150 mg given over four hours, and the first maintenance dose, which is 450 mg given in one hour two weeks later, and we combined that into one single 600 mg 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 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 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 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. 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 BRIUMVI and 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 it 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 in 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 I study evaluating azer-cel in progressive forms of multiple sclerosis, and we look forward to enrolling our first patients into this phase I 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 glycoengineered 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 I 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 2025, and our plans for the rest of the year. Adam.

Adam Waldman (Chief Commercialization Officer)

Thanks, Mike, and good morning, everyone. We are pleased to report another quarter of strong commercial performance, marking continued momentum as we close 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 J.P. Morgan 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. 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're 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 enhanced 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.

Sean Power (CFO)

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 gross 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.

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 J.P. Morgan 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 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 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.

Operator (participant)

Thank you. We'll now be conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. As a reminder, we ask you to please ask one question and one follow-up to 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 Agrawal with Cantor Fitzgerald. Your line is now live.

Prakhar Agrawal (Managing Director)

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 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.

Adam Waldman (Chief Commercialization Officer)

Mike, do you want me to take that?

Operator (participant)

Perhaps the phone is on mute.

Michael Weiss (Chairman and CEO)

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

Adam Waldman (Chief Commercialization Officer)

Yeah, Prakhar, thanks for the question. Our growth, taking the first question about the growth, our growth comes from, it's coming from a broad set of customers with enrollments 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 what 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.

Then for the high dose, I don't know if 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.

Michael Weiss (Chairman and CEO)

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.

Operator (participant)

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

Michael DiFiore (Pharmaceutical Specialty Analyst)

Hey, guys. Thanks for taking my call and congrats on all the progress. Two for me. Obviously, it seems like the pivotal phase III subcutaneous trial for BRIUMVI 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, expectations on gross to net for the balance of the year. Thank you.

Michael Weiss (Chairman and CEO)

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

Adam Waldman (Chief Commercialization Officer)

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

Michael Weiss (Chairman and CEO)

Okay. And the SUB-Q, yeah, 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 data there. We're still looking at the study design. And 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 III.

Michael DiFiore (Pharmaceutical Specialty Analyst)

Got it. Thanks so much.

Michael Weiss (Chairman and CEO)

You got it.

Operator (participant)

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

Ed White (Managing Director and Senior Biotechnology Analyst)

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 a competitive market that's already penetrated?

Michael Weiss (Chairman and CEO)

Yeah. 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 SUB-Q. 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 were 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's 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.

Ed White (Managing Director and Senior Biotechnology Analyst)

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-sized now, or continue to add there? And are there any marketing schemes going forward that might lead to increased SG&A costs?

Michael Weiss (Chairman and CEO)

Adam, you want to go ahead?

Adam Waldman (Chief Commercialization Officer)

Yeah, 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.

Michael Weiss (Chairman and CEO)

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

Sean Power (CFO)

No, nothing further. At this time.

Michael Weiss (Chairman and CEO)

Okay. Ed, just to quickly, 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 around 125-150 per arm, which is in line with the OCREVUS SUB-Q study for the SUB-Q arms.

Ed White (Managing Director and Senior Biotechnology Analyst)

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

Michael Weiss (Chairman and CEO)

Yep. Thank you.

Operator (participant)

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

Eric Joseph (Executive Director in Biotech Equity Research)

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 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 enhanced infusion regimen with BRIUMVI?

Michael Weiss (Chairman and CEO)

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 in large part because we had seen in the market that people were already taking folks on another CD20 and switching them to the 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 mg 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 the 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'd hope to have a BLA, potentially a PDUFA date for something like that, but mid-2027. So we'll keep you posted. But yeah, 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 with providing safety information through medical, but I don't know that that's going to go into a pivotal trial at this time.

Eric Joseph (Executive Director in Biotech Equity Research)

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 anti-CD20 approach might be adopted, particularly in relation to the anti-C5 and FcRn blockers?

Sean Power (CFO)

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 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 plant a flag and say MG is our next development program. But we do think it's interesting, and 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 the CD19/CD20 opportunity across autoimmune diseases is large, and whether it's with something like BRIUMVI, or there's 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 won't speak much to the complement side of it, but certainly between the CD19/CD20 landscape, and the FcRn, I mean. Who are working along a certain part of the continuum of B-cell to plasma to antibody depletion 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?

Eric Joseph (Executive Director in Biotech Equity Research)

Great. Thanks for taking the question.

Sean Power (CFO)

You got it.

Operator (participant)

Thank you. Next question is coming from Mayank Mamtani from B. Riley Securities. Your line is now live.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

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 where you stand based on how you look at switch from another DMT or CD20 therapy?

Michael Weiss (Chairman and CEO)

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

Adam Waldman (Chief Commercialization Officer)

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 of 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.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

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 questions.

Michael Weiss (Chairman and CEO)

Yeah, sure. So that study is ready to launch. We're ready to receive patients. This study is not yet enrolled in its first patients. So I'd like to say we're going to have lots and lots of patients, Mayank. 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 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 to 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, oligoclonal bands would be interesting. Certainly, we'll look at B-cell depletion and repletion. So 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 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.

Mayank Mamtani (Senior Managing Director and Group Head of Healthcare)

Great. Very helpful. Thank you, Mike.

Michael Weiss (Chairman and CEO)

Thanks, Mayank. Appreciate it.

Operator (participant)

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 closing comments.

Michael Weiss (Chairman and CEO)

Great. Thank you. And thanks again, everyone, for joining today's call. We've been incredibly pleased with the progress made in 2024, and of course, looking forward to an exciting 2025. I think you heard some really exciting developments, both on the commercial front and the early enrollments that we're seeing, giving us a really nice feel for the year. Just to restate some primary goals for us, commencing pivotal program for SUB-Q 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 I 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.

Operator (participant)

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