TG Therapeutics Inc

NASDAQ:TGTX

Earnings Call Analysis

TG Therapeutics Anticipates Continued Growth for BRIUMVI, Raising Sales Guidance

In the latest earnings call, TG Therapeutics reported third-quarter net sales of BRIUMVI at $83.3 million, marking a substantial 230% increase year-over-year. The company raised its full-year revenue guidance to $300-305 million, up from an earlier estimate of $220-260 million. BRIUMVI's profile remains strong, supported by favorable clinical data and growing market presence with nearly 1,100 prescribers targeting a 15% to 20% sequential sales growth in 2025. Additionally, the company plans to invest significantly in expanding commercial outreach and reducing infusion times, potentially positioning BRIUMVI as a leading therapy in the MS market.

BRIUMVI's Strong Market Performance

In the third quarter of 2024, TG Therapeutics reported impressive growth in its MS treatment, BRIUMVI, achieving net product revenue of $83.3 million. This marked a quarter-over-quarter increase of approximately 15% and a staggering over 230% from the same period last year. Year-to-date net revenue for BRIUMVI has reached $206.4 million, and the company anticipates raising its full-year guidance significantly, forecasting net U.S. sales between $300 million and $305 million, up from previous projections of $220 million to $260 million.

Clinical Developments Enhancing BRIUMVI’s Profile

BRIUMVI continues to find favor among healthcare providers, supported by robust clinical effectiveness data. The recently presented long-term results indicate that 92% of patients treated for five years experienced no disability progression. Additionally, an annualized relapse rate of only 0.02 highlights the drug's efficacy, essentially equating to one relapse every 50 years. This compelling data solidifies BRIUMVI's positioning as a potentially best-in-class treatment.

Strategic Investment in Commercialization

TG Therapeutics has strategically expanded its commercial field team, nearly doubling its workforce over the past two years. This increase is part of a focused effort to enhance provider engagement and patient access to BRIUMVI. The company has also launched patient awareness campaigns to educate potential users about the treatment, thereby facilitating more informed discussions between patients and healthcare providers.

Future Expansion Plans and Innovations

Looking ahead, TG Therapeutics is poised for continued growth. The company plans to pursue a subcutaneous (subcu) version of BRIUMVI, which could cater to patient preferences for at-home administration, potentially opening up new market opportunities. Furthermore, advancements such as a 30-minute infusion, reducing the current treatment time, are also in the pipeline. Accurate updates on subcu bioequivalence studies are expected by early next year, with pivotal trials anticipated to start mid-2025.

Financial Health and Cash Allocation Strategy

The company has concluded the quarter with approximately $341 million in cash and equivalents, reinforcing its financial stability. TG Therapeutics has initiated a share repurchase program to enhance shareholder value gradually, while also committing to investing in BRIUMVI's market development and research initiatives. The company's operational expenses are projected to remain below guidance, currently expected to land well under $250 million for the full year.

Market Dynamics and Growth Potential

Within the anti-CD20 therapy market, BRIUMVI holds about 15% share, with potential for substantial growth as dynamics shift. The overall CD20 market is anticipated to grow from the current low 50% dynamic share to potentially 55-60% in the near future. The company is eager to capitalize on this momentum, suggesting that an increased patient uptake in hospitals can lead to accelerated growth in 2025 and beyond.

Conclusion: Positioned for a Blockbuster Future

TG Therapeutics expresses strong confidence in BRIUMVI's trajectory toward becoming a blockbuster brand within the MS treatment landscape. Continued investments in marketing, clinical trials, and expanding treatment options suggest a commitment to enhancing patient outcomes and solidifying market presence. As the company advances its strategic initiatives, both in product development and financial management, shareholders can look forward to a potentially rewarding future.

Earnings Call Transcript 2024-Q3

[Operator]

Greetings, and welcome to the TG Therapeutics third quarter conference call and webcast. [Operator Instructions] as a reminder, this conference is being recorded.

It's now my pleasure to turn the call over to Jenna Bosco. Please go ahead.

[Jenna Bosco, executive]

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco. And with me today to discuss the third quarter 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 recent 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.

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. With that, I'd like to turn the call over to Mike Weiss, our CEO.

[Michael Weiss, executive]

Thank you, Jenna, and good morning, everyone, and thank you for joining us for our quarterly earnings call. We're excited to share with you the results of another quarter of growth and execution of our BRIUMVI launch.

The positive feedback and uptick for BRIUMVI the marketplace continues to outpace our expectations, and the strong data presented during the annual ECTRIMS meeting from the ULTIMATE I and II trials and the ENHANCE Phase IIIb trial both evaluating BRIUMVI and individuals with relapsing forms of MS continues to strengthen our belief in the long-term value of BRIUMVI. We remain highly focused on the commercial success of BRIUMVI, and I'm excited to share with you our current progress as well as our future plans to continue to grow BRIUMVI and shareholder value.

Let's kick things off with a brief review of the quarterly sales. I'm happy to report that BRIUMVI third quarter U.S. net sales were $83.3 million. Adam Waldman, our Chief Commercialization Officer, will join shortly to provide a full commercial update and year-end guidance. But I wanted to say that I'm extremely pleased with the continued commercial launch effort. The team continues to execute on our phased launch plan, setting us on what we believe is a path for continued growth and strong momentum heading into the end of the year and into 2025, and further toward our long-term goal of becoming the #1 prescribed anti-CD20 in terms of dynamic market share.

To that end, let's discuss some of the BRIUMVI data presented at the recent ECTRIMS Annual Meeting. As I alluded to earlier, we presented 2 important data sets during the meeting. The first was a long-term follow-up data from our open-label extension study from the ULTIMATE 1 and 2 Phase III trials, which, as a reminder, were the core trials that supported the approval of BRIUMVI for individuals with relapsing forms of MS. After 5 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, which is equivalent to 1 relapse occurring every 50 years of treatment. And importantly, the overall safety profile remained consistent over 5 years of continuous BRIUMVI treatment with no new safety signals emerging with prolonged usage.

As we've stated previously, we believe we have set the standard for convenience in IV CD20 therapy, and we continue to look for ways to further streamline the patient experience. At ECTRIMS, we updated data previously presented at AAN in April from our ENHANCE study, showing that individuals with the relapsed forms of MS who were B-cell depleted on the current anti-CD20 therapy and were switched to BRIUMVI were able to tolerate the 1-hour BRIUMVI infusion without first receiving the 4-hour introductory dose. Currently, all IV CD20s used to treat MS require 2 infusions in the first 2 weeks to initiate therapy. This approach would only require 1 visit to start BRIUMVI.

Additionally, at ECTRIMS, we presented data for the first time on a faster 30-minute BRIUMVI infusion from our ENHANCE trial. The data presented, while still preliminary, so that the first maintenance dose of BRIUMVI given as a 30-minute infusion as opposed to 1 hour,was well tolerated with all infusion-related reactions being mild, grade 1 and resolved completely. We have now treated over 50 individuals with RMS with 30-minute BRIUMVI and look forward to presenting updated data at a future medical conference.

As you can imagine, more testing including randomized trials will be needed to incorporate these potential updates into our label. But hopefully, this highlights our longer-term vision to continually seek to improve the patient journey with BRIUMVI and maintain what we believe is a best-in-class profile.

And further to achieving that goal, I'd like to remind everyone that we are also developing a subcu version of BRIUMVI. While the majority of individuals with MS choose IV CD20 delivered every 6 months, which is how BRIUMVI is currently offered and we expect that to continue, the at-home, self-administered subcu market is meaningful. Accordingly, we believe that offering an at-home self-administered subcu BRIUMVI would open up a new market opportunity for us. We expect to be able to provide an update from our BRIUMVI subcu bioequivalence study by early next year. And if all goes well, we'll be targeting a pivotal trial commencing in the middle of 2025.

And finally, beyond BRIUMVI on the R&D front. We previously shared that the U.S. FDA has cleared our investigational new drug application, IND, for azer-cel, an off-the-shelf allogeneic CD19 CAR T cell therapy for the treatment of autoimmune diseases. The team has been working hard to move this forward, and we are targeting launching a Phase I study around the end of this year or early next year, starting in individuals with progressive MS. This is an exciting new opportunity that we believe may offer a new treatment for individuals with progressive MS who have few options.

Switching gears a little bit. I want to highlight a recent transaction related to manufacturing and supply. As you may be aware from our public filings, we currently manufacture BRIUMVI at Samsung Biologics in South Korea, who are recognized as the global leaders in biologics manufacturing and who have been and continue to be a great partner to TG. As BRIUMVI continues to grow, as we continue to believe the blockbuster potential of BRIUMVI, from a risk management standpoint, we felt it was time to engage a secondary manufacturer of BRIUMVI.

Accordingly, we are happy to announce we have secured FUJIFILM Diosynth Biotechnologies as a second manufacturer of BRIUMVI at their facility based here in the United States. As we continue to expand our commercialization efforts in MS and think about the future of BRIUMVI, we believe this is an important next step that will continue to support our growth plans and provide additional security for our drug supply.

In closing, I want to thank all of our TGers for their hard work and commitment to people living with MS. Our progress is a testament to our collective efforts, and I'm excited about the path forward. Through your efforts, TG is poised to become a new leader in the MS market, focused on developing and delivering innovative therapies for multiple sclerosis.

With that, I'll hand the call over to Adam Waldman, our Chief Commercialization Officer, to walk you through our commercial performance in more detail. Thank you. Adam, go ahead.

[Adam Waldman, executive]

Yes. Thank you, Mike. I'm excited to share the continued commercial success we've experienced with BRIUMVI and the steps we are taking to drive future long-term growth. Since its launch, BRIUMVI has consistently exceeded our expectations, with Q3 marking another strong quarter of sequential revenue growth.

As Mike mentioned, we achieved second quarter net sales of $83.3 million, reflecting approximately 15% quarter-over-quarter growth and over 230% growth from the same quarter last year, solidifying BRIUMVI as the fastest-growing DMT in the U.S. MS market. And while we did observe some expected summer dynamics in the third quarter where new patient visits tend to slow, particularly during July and August, enrollments into our hub rebounded in September, and that momentum continued into October where we saw a record enrollment month.

We continue to see steady growth in new prescribers and treatment centers, now reaching nearly 1,100 prescribers across approximately 600 centers, including 95% of the top 100 MS centers since launch. Encouragingly, 2/3 of the new prescribers in Q3 came from the hospital setting, which is now our fastest-growing segment and accounts for approximately 55% of our overall business.

We continue to believe in BRIUMVI best-in-class profile, including its high level of efficacy, well-established safety profile and a 1-hour infusion every 6 months. attributes which we believe strongly resonate with health care providers looking for a convenient yet highly effective treatment option.

We are particularly excited to see the overwhelming positive response to BRIUMVI at the ACTRIMS Conference in September. As Mike mentioned, BRIUMVI was featured prominently, and the clinical data we presented garnered strong interest from health care providers and thought leaders in the MS community.

Several key takeaways emerged from the conference from a commercial perspective. First, we believe the ENHANCE trial, which showed the potential for BRIUMVI to have a rapid 30-minute infusion, could represent a significant enhancement to our profile. Second, the ENHANCE trial showed the potential to switch from a CD20 to BRIUMVI without requiring a loading dose. We believe this will make switching potentially easier for many patients who may not be satisfied with their current CD20 therapy. And finally, the open-label extension presentation underscored BRIUMVI's long-term efficacy and safety, reinforcing its potential best-in-class profile.

The data demonstrated an impressive annualized relapse rate of just 0.02 at 5 years, equivalent to 1 relapse for 50 patient years, along with consistent 5-year safety data. We believe this information reinforces BRIUMVI's value proposition and will particularly resonate with physicians and patients who seek established long-term data before adopting new therapies. The visibility and recognition BRIUMVI received at ECTRIMS have certainly strengthened our confidence in its long-term positioning as the preferred anti-CD20 therapy in relapsing forms of MS.

Another contributing factor of BRIUMVI's growing success is the expansion of our commercial infrastructure. Over the last 2 years, we have nearly doubled our commercial field team, ensuring that we can adequately support the rising demand for BRIUMVI and increase our reach within key MS treatment centers. This expansion has allowed us to increase our presence across the U.S. market. As a result, we've been able to engage and educate more physicians on the BRIUMVI product profile.

Alongside the commercial team expansion, we have also started to increase our investments in patient awareness. Recognizing that informed patients are often key drivers in treatment decisions, we have launched targeted awareness campaigns aimed at educating patients on the benefits of BRIUMVI. These campaigns are aimed at empowering patients to have informed discussions with their health care providers. We believe that by raising awareness directly among patients, we can further accelerate adoption and ensure that more individuals living with relapsing forms of MS can benefit from BRIUMVI's unique profile.

Our patient-centric strategy will remain a focal point as we continue expanding our outreach efforts in 2024, and we plan to significantly increase investment in these activities in 2025 and beyond.

Since launch, we've made significant strides in ensuring BRIUMVI's availability and access. As I mentioned previously, this has always been a prioritized area for us, and we are pleased that we maintained 95% coverage with national and regional payers. Additionally, our team is doing an exceptional job facilitating the reimbursement process and working with customers and patients to make sure patients can access BRIUMVI. We have worked diligently to streamline the patient journey, ensuring that BRIUMVI is accessible with minimal delay, which has helped sustain our patient adherence and satisfaction. Our time to infusion continues to decrease and our persistence at week 24 continues to exceed our expectations.

Our performance this quarter reinforces our belief that BRIUMVI's profile continues to resonate in the market, and our commercial organization is very capable of continuing to deliver results. As we look to Q4 and beyond, we expect to see continued growth, and accordingly, we are raising our full year guidance for BRIUMVI net U.S. sales to $300 million to $305 million. We continue to exceed our expectations and have raised this number substantially from our original full year guidance of $220 million to $260 million provided in early 2024.

We continue to be excited about what lies ahead. Our foundation is strong. We are poised to capture more growth in the coming quarters. And we are -- we believe we are well positioned to grow BRIUMVI into a blockbuster brand.

In conclusion, I want to thank our team for their dedication and our hard work. Their outstanding efforts are contributing to the positive experience with BRIUMVI and confidence in our organization. I also want to thank the health care providers and their patients for their trust in TG Therapeutics. Together, we will continue to improve outcomes for those in need. We certainly have more work to do, but we're focused and extremely motivated, continue to work every day to bring BRIUMVI to those living with MS and their families.

With that, I'll turn the call over to Sean Power, our CFO.

[Sean Power, executive]

Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning, we reported our detailed third quarter 2024 financial results, which can be viewed on the Investors & Media section of our website.

This morning, I'll start by highlighting our Q3 revenue. As Adam detailed earlier, we are pleased to report third quarter BRIUMVI net product revenue of $83.3 million for the 3-month period, bringing our year-to-date 9-month BRIUMVI net product revenue to $206.4 million.

Turning now to our income statement for the period. We are pleased to report that we generated net income in both the 3 and 9-month periods ending September 2024. For the 3 months ended September 30, 2024, our GAAP net income was approximately $3.9 million or $0.02 per diluted share. When excluding noncash items, net income for the 3-month period was approximately $15.7 million.

Our OpEx during the quarter, excluding noncash items, came in at the low end of our guided range at approximately $50 million. Our OpEx for the first 9 months of 2024 is approximately $155 million. And for the full year, we expect our OpEx to come in well below the guidance of approximately $250 million.

And finally, I'll close by touching briefly on our cash position. We ended the third quarter with approximately $341 million in cash, cash equivalents and investment securities, which we believe provides us with a strong financial position to support the BRIUMVI commercialization, our research and development efforts and our continued business operations for the foreseeable future.

On a related note, I'd like to briefly touch on our share repurchase program, which we commenced during the third quarter. We began slowly buying shares back during the third quarter and will continue with a measured approach for the foreseeable future. Although the share amounts repurchased during the third quarter were minimal, we do expect this program to continue throughout the remainder of the year and into 2025.

With that, I will now turn the call back over to the conference operator to begin the Q&A.

[Operator]

[Operator Instructions] Our first question today is coming from Ed White from H.C. Wainwright.

[Edward White, analyst]

First, I wanted to ask a big picture question. You mentioned in the press release that you expect to see continued growth in 2025. I just wanted to get your thoughts on the size of the anti-CD20 market in MS in 2025 and your thoughts on market share not only for BRIUMVI but also IV versus subcu.

[Michael Weiss, executive]

Thanks, Ed, for the question. Adam, do you want to take a crack at that one?

[Adam Waldman, executive]

Sure, Ed. So big picture, I mean, we see CD20 continuing to grow. It's in the low 50% of dynamic share today. We see no reason that, that can't continue to grow to mid-50s to even 60%. I think the momentum continues behind the class. As far as our market share growth, we're about 15% of the CD20 market today, and we think we have a lot of room to grow.

[Edward White, analyst]

Okay. And just a question on the announced FUJIFILM secondary U.S.-based manufacturing. Your gross margins have been pretty consistent this year quarter-over-quarter. Will this agreement have any impact on gross margin going forward?

[Michael Weiss, executive]

Sean, you want to tackle that?

[Sean Power, executive]

Ed, thanks for the question. In the near term, absolutely not. We'll have some upfront expenditures associated with that, but that will of course run through R&D. And in the long term, we think gross margins would remain consistent. So a short answer to your question is, no, no real impact on gross margin.

[Adam Waldman, executive]

Yes. Ed, I forgot to answer one part of your question which was the IV to subcu. We believe it's around 70% IV to subcu in terms -- and we do still believe it is, as Mike said in his remarks, the clear patient preference today. And we see that continuing.

[Edward White, analyst]

Congratulations on the quarter.

[Michael Weiss, executive]

Thanks, Ed.

[Operator]

Next question is coming from Michael DiFiore from Evercore ISI.

[Michael DiFiore, analyst]

Congrats on the quarter. Two for me. Were there any inventory channel dynamics during 3Q? And separately, what was the TRx script count in 3Q? And how many new patient scripts have been received in the hub? I noticed that wasn't included in your print this morning.

[Michael Weiss, executive]

Sure. Thanks for the question. Adam, you want to tackle those, the inventory and TRx?

[Adam Waldman, executive]

Yes. First question, Michael, there's no changes in inventory in the quarter. All distributors are at normal inventory levels. And as far as the enrollments, we're going to move away from providing that number. I think as we continue to grow our hospital business, the -- our capture rate continues to go down in terms of -- because hospitals are just less likely to use our hub. So we just don't think that this is going to be an accurate measure going forward.

I think directionally, it can help certainly. But I think in sort of using it as a way to sort of garner whether we're growing or not growing, it's just with the capture rate fluctuating and more and more hospitals coming into play that are certainly just not using it. we've decided to focus more on the revenue guidance as we've done over the past several quarters and we'll continue to do going forward.

But we just don't think hub enrollments are -- it was good in the beginning. I think certainly in the beginning where we had a much higher percentage of our business coming from private practices that use the hub much more consistently, it was a good measure. As we continue to go out here, as more -- I said in our remarks, about 55% of our business now is coming from hospitals, it's the fastest growing of our segment, and then just less likely to use our hub. And that creates some difficulty in interpreting the information out of the hub enrollment data.

[Operator]

Next question is coming from Eric Joseph from JPMorgan.

[Eric Joseph, analyst]

Just picking up on the plan to adopt for a faster infusion time, just coming out of the ENHANCE update at ECTRIMS. Can I get you to elaborate a little bit more on sort of what you -- what might be needed to support a label indication for either a shorter infusion or skipping a loading dose for switch patients? You mentioned possibly needing randomized data. Would the focus there be exclusively on safety? And would you need to assess more than 1 infusion per patient as part of that -- as part of a trial like that?

[Michael Weiss, executive]

Yes. Thanks for the question, Eric. So the answer to the last part of your question, will we need more than 1 infusion, is probably unclear today. But I don't think so. I don't think we'll need more than 1 infusion for patients to tell on the safety. And yes, it's primarily a safety study. For faster infusions, historically, when you -- they've been done before with other companies and they do require randomized trials. And they usually are looking at safety and tolerability. I think that's what we're -- our expectations are.

[Eric Joseph, analyst]

Okay. Great. And maybe a follow-up, if I could, with respect to the subcu initiative. Can you talk a little bit about sort of what you are tracking in addition to safety to kind of verify or sort of assess how long of a dosing interval you could ultimately move forward within a pivotal study?

[Michael Weiss, executive]

Yes. So again with subcu, we're looking at primarily the bioequivalence. So again, it's just the amount of material required to match the PK. And yes, that will determine the tolerability of the materials. If you put too much in, you would at some point start to see a deterioration in tolerability at the injection site.

But the primary focus is the bioavailability. That will tell you how much material you need to load into the injection, and that will ultimately, as you mentioned, impact how tolerable it is. So it's -- all of those pieces will come together at some point soon. We're hoping, like I said, to be able to share that data early next year. But those are basically 3 pieces that have to come together. .

[Eric Joseph, analyst]

Is there a PD component? Are you looking at sort of a B cell decline?

[Michael Weiss, executive]

Yes. I could share with you that B-cell decline is not an issue in any real dose level.

[Operator]

Your next question is coming from Tara Bancroft from TD Cowen.

[Tara Bancroft, analyst]

So thinking about your guidance, it assumes just over -- or I guess, just under 20% sequential growth, and that's incrementally higher than the 15% from Q3. But I was wondering, looking ahead now, should we assume steady growth like this from here on out or a similar cadence of growth like in 2025 like you saw this year with -- and last year with a heavy Q2 and seasonal impacts? Just a bit on how you envision near-term dynamics here would be really helpful.

[Michael Weiss, executive]

Sure. Thanks. Adam, do you want to talk a little?

[Adam Waldman, executive]

Sure. Yes. Thanks for the question, Tara. I mean, we try to provide the best information we have when we have it. I think the guidance is strong and shows sequential revenue growth. We're continuing to do some things here and make some investments and as I mentioned in my remarks around patient awareness and other things, that we are hoping will continue to fuel the trajectory of the growth of this product.

As I mentioned, we think we're poised to make this a blockbuster brand and that trajectory. I think there are seasonal -- if you look at the MS market in general, there are some quarterly season dynamics that are in play. As I mentioned, in Q3, there were some in just the summer months that can affect the exact line. But I think we are poised to grow more. We're doing things in the market that are getting traction, and we're very excited about what the future is for BRIUMVI.

[Tara Bancroft, analyst]

Okay. Great. And just a quick follow-up on the previous question about subcu. I understand you mentioned a lot of expectations there, which was helpful. But can you tell us what volume and perhaps dosing interval that you're ideally targeting with the subcu formulation?

[Michael Weiss, executive]

Sure. Yes. So I mean, ideally it would be a less frequently as possible. I think sort of a minimum bar would be certainly every other month, I think, is the minimum bar that we're targeting. And even less frequently than that, we think would be fantastic, and we'll be obviously working towards that, of course. But no promises. But yes, that's -- the minimum profile, I think, would be every other month is the target for that.

[Operator]

Your next question today is coming from Matt Kaplan from Ladenburg Thalmann.

[Matthew Kaplan, analyst]

Congrats on the quarterly results. I guess for Adam, can you expand on the rates of persistence you're seeing and how it compares to other therapies in the space?

[Adam Waldman, executive]

Yes, Matt, thanks for the question. We -- the only compliance numbers that we have or that we see that are published are with the other IV CD20 competitor. And we're doing -- so that's been sort of our benchmark and what we're expecting. And we continue -- it looks like -- and again, we're continuing to collect data, but it looks like we're doing at least as good, if not better, on the week 24 compliance than what's out there and published.

[Matthew Kaplan, analyst]

Okay. Great. And just a follow-up on the ENHANCE data on the questions with respect to when you could see that incorporated into clinical practice. When do you think you could complete the studies necessary to have that available and update the label?

[Michael Weiss, executive]

Yes. Thanks, Matt. So the goal would be to get those studies started sometime next year. Those studies, again, with enrollment. It's a randomized trial of reasonable size. It's, give or take, 200 to 300 subjects. It's going to take at least a year or so. We've got a year of enrollment. Follow-up should be short. So we should be able to follow the patients and get that data put together pretty quickly and get a filing. And so I think we're -- even in best case scenario, it's probably a 2- to 3-year process to get you into the label.

[Operator]

Next question today is coming from Mayank Mamtani from B. Riley Securities.

[Mayank Mamtani, analyst]

Team, congrats on a strong quarter. So on the revenue split, if you are able to share between maintenance and maybe new to BRIUMVI patients, and if you are able to confirm at what juncture the maintenance patients of BRIUMVI takes over the new to BRIUMVI patients?

And did you comment on by any chance on the share for new to CD20 versus newly diagnosed RMS patients? And would love to hear any color you are seeing in the marketplace on -- within the intra-CD20 class switch, what percent patients set up for grabs? Would love to hear any perspective on that.

[Michael Weiss, executive]

Sure. Thanks, Mayank. Adam, do you want to [ crack ]?

[Adam Waldman, executive]

Yes. As far as the first question, the revenue split is still mostly new versus repeat. But we do expect in the next several quarters that, that will turn upside down, right? Repeat prescriptions will start to be the lion's share of the infusions going in the next couple of quarters as we continue to stack -- the stacking effect and we continue to get patients coming back for week 48 and so on and so forth.

So -- but today, it's still news that's the majority. But in the next several quarters, we do expect repeat to increase and become the dominant amount of -- from a revenue split perspective. The -- I think the second question was share of newly diagnosed, is that right, Mayank?

[Mayank Mamtani, analyst]

Yes. That's a accurate.

[Adam Waldman, executive]

Yes. We haven't provided shares in newly diagnosed or new to CD20. We haven't provided those shares. And then your third question was about switching. And we do see -- we continue to see a sizable portion of our BRIUMVI business coming from switches from both OCREVUS and KESIMPTA, and that has remained pretty steady and consistent since launch.

[Mayank Mamtani, analyst]

Yes. Because one of our recent surveys indicated up to 20% of the patients might be up for grabs, so hence the question. And then lastly, on the biologics manufacturing expansion implication. Are you able to comment on any long-term supply goal that you may have in mind between the Korea and U.S. facilities? Any way to quantify that would be very helpful, Mike.

[Michael Weiss, executive]

Yes. So I don't think we have a good answer for you at this moment, Mayank. But obviously, we're securing what we think is what is required for a long-term supply between both of Samsung and Diosynth, FUJI.

[Operator]

Next question is coming from Corinne Johnson from Goldman Sachs.

[Corinne Jenkins, analyst]

Maybe a couple from us. You talked about the bulk of growth in your patients coming from the hospital setting. I guess, remind us a portion of MS patients are taken care of there and why do you think that's been such a good source of new patient growth for you.

And then my second question is, as you think about 2025, could we see steady or even maybe accelerating new patient growth on an absolute basis into year 3 as you get kind of like well into the launch here?

[Michael Weiss, executive]

Sure. I'll start with the second question. Yes, I mean, certainly we do believe that we're kind of accelerating new patient starts as we get into 20205. We've always felt that just generally speaking, the more patients that go on BRIUMVI, more patients will go on BRIUMVI. So there's definitely sort of an inflection point that comes with that when you have enough people on it and have the critical mass. So we think that's part of it.

As Adam mentioned in his prepared remarks, we are taking steps to push as hard as we can to get to that inflection point whenever and how many patients that may be. We've expanded the size of our commercial team. We're expanding our marketing efforts coming into 2025. So yes, I mean, is it possible? Obviously, I can't promise it. I mean, I don't think the 15% to 20% quarter-over-quarter steady growth that we've had thus far is problematic. I think it's pretty darn good and will continue to bring us to a blockbuster within a short amount of time. But yes, I think it is also possible that the growth rate could accelerate as we get into 2025.

Adam, do you want to take the one about the hospital setting and the percentage of business that comes from hospitals?

[Adam Waldman, executive]

Yes, yes. So Corinne, it's probably 60% to 65% of patients are being seen in the hospital setting. That's why we're -- we think having continued expansion into that hospital segment is encouraging. And it is now the fastest-growing segment, as I mentioned in my prepared remarks. And it is where the majority of the patients in the U.S. today are being treated.

[Operator]

Our next question today is coming from Prakhar Agrawal from Cantor Fitzgerald.

[Prakhar Agrawal, analyst]

Congrats on the quarter. Maybe firstly, now that subcu OCREVUS has launched, what are you seeing on the ground in terms of where it's gaining more share from, even qualitatively?

And second question, you've started generating obviously a lot of cash over the next few years. Maybe on the broader capital allocation priorities, is there any plans to expand the share buyback program? Or any other mechanisms you can explore on the capital allocation front?

[Michael Weiss, executive]

Sure. Thanks, Prakhar. Adam, do you want to talk about what we've seen in competitive dynamics in the market recently?

[Adam Waldman, executive]

Sure. Yes. So Prakhar, thanks for the question. We've seen no impact from OCREVUS de novo to date. We had -- as I mentioned in the prepared remarks, we had the best month of enrollments ever in October. So no impact as far as we can tell right now.

[Michael Weiss, executive]

And Prakhar, in terms of allocation of cash, yes, well, Sean did mention that we've been -- we started off conservatively with the share buyback program. It is something that we're committed to continuing on an ongoing basis. So yes, we do believe we'll be allocating over time more cash to share buybacks.

But in addition, as Adam again in his prepared remarks and as I alluded to in the prior answer, we're committed to expanding the use of BRIUMVI. So obviously, we're going to be allocating cash toward continuing to build and grow our team, continuing to build and grow our marketing efforts which, as everyone has followed us closely, knows we started out with a pretty modest marketing budget when we launched in '23. And I think by the time we get to '25, we'll have a pretty healthy marketing budget.

So again, I think we're leaning into the opportunity. We see BRIUMVI as a blockbuster brand, and we're going to make sure we try to get there as quickly as we can. So we will be using cash and investing in those activities. And as part of that again, we'll be investing in these clinical programs that you heard about earlier, right? So we're going to be running more likely than not several randomized trials commencing in 2025 for faster infusions, skipping the doses to streamline the front end and, of course, subcu, which is obviously the highest of the priorities of that grouping.

So we're going to make investments in those as well. So that's where some of the excess cash goes. Obviously, as we mentioned, azer-cel is moving forward and we're excited about the potential there. And then lastly, our eyes are peeled and our business development program is active. And if we see something that we think really augments and complements what we're doing, we're going to make investments there as well. So I think we've got plenty of potential uses for the excess cash, although we're not dogmatic about how it gets spent except, I'd say, on the front end with the investments in making sure BRIUMVI gets as quickly as possible to that blockbuster level.

[Operator]

Next question is coming from Roger Song from Jefferies.

[Jiale Song, analyst]

Congrats for the quarter. Most of my questions related to BRIUMVI had been answered. And then maybe just a follow-up on the capital allocation for those additional pipeline. So one is in terms of the BRIUMVI expanding to non-MS indication, when you start the trial later this year and then would you be able to give us -- provide some proof of concept data to support the plan? Number one.

Number two is in terms of the allogeneic cell therapy. Do you expect to give us some data update next year? And then what will be the principle to share the data in terms of the number of patients and then the maturity of the data?

[Michael Weiss, executive]

Yes. Thanks, Roger. So I'll start second since it's the fresh question, then I'll work backwards the question. Yes, I mean, look, we're hopeful to get that study started later this year. So we've got 2 months left to put our first patient in. If not, it will be early next year. The cadence of data coming out of that trial, I think, is yet to be determined. We'll hopefully get some patients on as quickly as we can. It's the logistics of these trials and the ability to put patients on rapidly is not the same as working with other biologics. So -- but if we can get a decent number of patients on as quickly as we can, hopefully we can get some data out sometime next year.

But I wouldn't anticipate any available data until the second half and more likely than that, second half of the year. But again, it's hard to really tell how fast we can enroll, although, again historically these studies have enrolled slowly. So let's keep a hopeful eye on that. Because I do think it has a lot of promise in the areas in which we intend to study, particularly progressive MS that and some other areas that we have slated to look into. So TBD on that one, Roger. We'll keep you posted.

And in terms of the BRIUMVI outside MS plans, I could say from the beginning of the year, we did note that, that was probably the lowest of our near-term interest and priorities. I think we are working toward getting some patients on non-MS indications before the end of this year still, and we can report on that if and when it happens. I think part of the challenge in our plans outside of MS right now are really evaluating all the options. I mean, there's been so much new CD20 and B cell data that's come out across multiple disease areas that we've been really taking our time. And I know we've said this before, but with the new information, gives us more options to look at and decide. And it's also the thought of whether it's an IV opportunity or potentially subcu opportunity as you move into some of these other indications.

So I don't have any specifics to discuss today, but it is definitely on the radar screen. The team is working on putting non-MS patients into trials this year, and the commercial team certainly is helping us to evaluate what the next best indications are going to be. And I'm assuming 2025, we'll talk more about that and we'll get that up and running.

[Operator]

We reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments. .

[Michael Weiss, executive]

Great. Thank you. And thanks again, everyone, for joining us on today's call. We look forward to continuing the positive momentum into the end of the year and into next year. And as discussed today, we'll continue to be focused on several key priorities, first, expanding our BRIUMVI launch effort, including building out our commercial footprint and increasing our spend in marketing; next, advancing our BRIUMVI expansion initiatives through our subcutaneous development, our enhanced switch study in exploring new indications for BRIUMVI; and finally, commencing our Phase 1 azer-cel in progressive MS as well as looking at opportunities to expand our pipeline.

With that, I'd like to close by thanking those with MS and their health care providers who put their trust in TG and BRIUMVI and our loyal shareholders for their support and once again, the whole team for making it all happen. Have a great day.

[Operator]

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