TG Therapeutics Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
November 4, 2024

There are 14 speakers on the call.

Operator

Greetings, and welcome to the TG Therapeutics Third Quarter Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Jenna Bosco.

Operator

Please go ahead.

Speaker 1

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the Q3 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 and 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.

Speaker 1

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.

Speaker 1

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.

Speaker 2

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 Briohnve launch. The positive feedback and uptake for BRYANVI in the marketplace continues to outpace our expectations and the strong data presented during the annual XTRIMS meeting from the ULTIMATE I and II trials and the ENHANZE Phase IIIb trial, both evaluating BREONVY in individuals with relapsing forms of MS, continues to strengthen our belief in the long term value of BREONVY. We remain highly focused on the commercial success of BREONVY, and I'm excited to share with you our current progress as well as our future plans to continue to grow Breomby and shareholder value. Let's kick things off with a brief review of the quarterly sales.

Speaker 2

I'm happy to report that Briometry 3rd quarter U. S. Net sales were $83,300,000 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 number one prescribed anti CD20 in terms of dynamic market share. To that end, let's discuss some of the Brianca data presented at the recent XTRM's annual meeting.

Speaker 2

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 3 trials, which as a reminder, were the core trials that supported the approval of BREOMBI for individuals with relapsing forms of MS. After 5 years of Briohn B treatment, 92% of patients were free from disability progression. And in the 5th 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 Breomby treatment with no new safety signals emerging with prolonged usage.

Speaker 2

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 XTRIMS, we updated data previously presented at AN in April from our ENHANCE study, showing that individuals with relapsing forms of MS were B cell depleted on their current anti CD20 therapy and were switched to Briohnvy, were able to tolerate the 1 hour Briohnvy infusion without first receiving the 4 hour introductory dose. Currently, all IV CD20s used to treat MS require 2 infusions in the 1st 2 weeks to initiate therapy. This approach would only require one visit to start Briohnvy. Additionally, at Xtrem's, we presented data for the first time on a faster 30 minute Breomby infusion from our ENHANZE trial.

Speaker 2

The data presented, while still preliminary, showed that the first maintenance dose of Briohnve 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 Briumby 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 Breomby 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 Breomby. While the majority of individuals with MS choose IV CD20 delivered every 6 months, which is how Briombe is currently offered, and we expect that to continue, the at home self administered subcu market is meaningful.

Speaker 2

Accordingly, we believe that offering an at home self administered subcu Briombe would open up a new market opportunity for us. We expect to be able to provide an update from our Briohnvy subcu bioequivalent 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 Briohnve on the R and D front, we previously shared that the U. S.

Speaker 2

FDA has cleared our investigational new drug application IND for AzerCell, and 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 Briomvi 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.

Speaker 2

As Briomvi continues to grow, as we continue to believe the blockbuster potential of Briombe, from a risk management standpoint, we felt it was time to engage a secondary manufacturer of Briombe. Accordingly, we are happy to announce we have secured FUJIFILM Diosynth Biotechnologies as a second manufacturer of Briombe out of the facility based here in the United States. As we continue to expand our commercialization efforts in MS and think about the future of Briombe, we believe 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 TGE'ers 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.

Speaker 2

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.

Speaker 3

Yes. Thank you, Mike. I'm excited to share the continued commercial success we've experienced with Briohnvy and the steps we're taking to drive future long term growth. Since its launch, Briohnvy has consistently exceeded our expectations, with Q3 marking another strong quarter of sequential revenue growth. As Mike mentioned, we achieved 2nd quarter net sales of $83,300,000 reflecting approximately 15% quarter over quarter growth and over 2 30% growth from the same quarter last year, solidifying Breomby as the fastest growing DMT in the U.

Speaker 3

S. MS market. And while we did observe some expected summer dynamics in the Q3, where new patient visits tend to slow, particularly during July 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 1100 prescribers across approximately 600 centers, including 95% of the top 100 MS centers since launch. Encouragingly, twothree 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.

Speaker 3

We continue to believe in Brienbi's 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 healthcare providers looking for a convenient, yet highly effective treatment option. We were particularly excited to see the overwhelming positive response to Briomby at the Actrims Conference in September. As Mike mentioned, Briomby was featured prominently and the clinical data we presented garnered strong interest from healthcare providers and thought leaders in the MS community. Several key takeaways emerged from the conference from a commercial perspective. First, we believe the ENHANZE trial, which showed the potential for BIOMBI to have a rapid 30 minute infusion, could represent a significant enhancement to our profile.

Speaker 3

2nd, the ENHANCE trial showed the potential to switch from a CD20 to Briohnii 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 Breomby'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 per 50 patient years, along with consistent 5 year safety data. We believe this information reinforces Breomni's value proposition and will particularly resonate with physicians and patients who seek established long term data before adopting new therapies.

Speaker 3

The visibility and recognition Breomby received at Xrem have certainly strengthened our confidence in its long term positioning as the preferred anti CD20 therapy in relapsing forms of MS. Another contributing factor to Briombe's growing success is the expansion of our commercial infrastructure. Excuse me, over the last 2 years, we have nearly doubled our commercial field team, ensuring that we can adequately support the rising demand for Briombe and increase our reach within key MS treatment centers. This expansion has allowed us to increase our presence across the U. S.

Speaker 3

Market. As a result, we've been able to engage and educate more physicians on the BRYANVI 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 and treatment decisions, we have launched targeted awareness campaigns aimed at educating patients on the benefits of Briohnve. These campaigns are aimed at empowering patients to have informed discussions with their healthcare providers.

Speaker 3

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 Breomby'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 Assurance Breombe in ensuring Breombe's availability and access. As I mentioned previously, this has always been a prioritized area for us and we are pleased that we maintain 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 Breomby.

Speaker 3

We have worked diligently to streamline the patient journey, ensuring that Breomby 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 Breomby'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 BRYANV net U. S.

Speaker 3

Sales to $300,000,000 to $305,000,000 We continue to exceed our expectations and have raised this number substantially from our original full year guidance of $220,000,000 to $260,000,000 provided in early 2024. We continue to be excited about what lies ahead. Our foundation is strong. We're poised to capture more growth in the coming quarters, and we believe we are well positioned to grow Breomby into a blockbuster brand. In conclusion, I want to thank our team for their dedication and hard work.

Speaker 3

Their outstanding efforts are contributing to the positive experience with Breomby and confidence in our organization. I also want to thank the healthcare 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 Vionvii to those living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO.

Speaker 4

Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning, we reported our detailed Q3 2024 financial results, which can be viewed on the Investors and Media section of our website. This morning, I'll start by highlighting our Q3 revenue. As Adam detailed earlier, we are pleased to report 3rd quarter Breomby net product revenue of $83,300,000 for the 3 month period, bringing our year to date 9 month Breanvie net product revenue to $206,400,000 Turning now to our income statement for the period, we are pleased to report that we generated net income in both the 3 9 month periods ending September 2024. For the 3 months ended September 30, 2024, our GAAP net income was approximately $3,900,000 or $0.02 per diluted share.

Speaker 4

When excluding non cash items, net income for the 3 month period was approximately $15,700,000 Our OpEx during the quarter, excluding non cash items, came in at the low end of our guided range at approximately $50,000,000 Our OpEx for the 1st 9 months of 2024 is approximately $155,000,000 And for the full year, we expect our OpEx to come in well below the guidance of approximately $250,000,000 And finally, I'll close by touching briefly on our cash position. We ended the 3rd quarter with approximately $341,000,000 in cash, cash equivalents and investment securities, which we believe provides us with a strong financial position to support the Breomby 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 Q3. We began slowly buying shares back during the Q3 and will continue with a measured approach for the foreseeable future. Although the share amounts repurchased during the Q3 were minimal, we do expect this program to continue throughout the remainder of the year and into 2025.

Speaker 4

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

Operator

Thank you. We will now be conducting a question and answer session. Our first question today is coming from Ed White from H. C. Wainwright.

Operator

Your line is now live.

Speaker 5

Good morning. Thanks for taking my questions. 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 Breumdi, but also IV versus sub Q?

Speaker 2

Q? Adam, you want to take a crack at that one?

Speaker 3

Sure. Good morning, Ed. Sure. So big picture, I mean, we see CD20 continuing to grow. It's in the low 50 percent of dynamic share today.

Speaker 3

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.

Speaker 5

Okay, thanks. And just a question on the announced Fuji Film Secondary U. S. Based manufacturing. Your gross margins have been pretty consistent this year quarter over quarter.

Speaker 5

Will this agreement have any impact on gross margin going forward?

Speaker 2

Sean, you want to tackle that?

Speaker 4

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 and D. And in the long term, we think gross margins would remain consistent. So short answer to your question is no real impact on gross margin.

Speaker 3

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

Speaker 5

Great. Thanks, Adam, and thanks to everyone. Congratulations on the quarter.

Speaker 2

Thanks, Ed.

Operator

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

Speaker 6

Hey, guys. Thanks so much

Speaker 7

for taking my question and congrats on the quarter. 2 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?

Speaker 7

I noticed that wasn't included in your print this morning. Thank you.

Speaker 2

Sure. Thanks for the question. Adam, do you want to tackle the inventory in TRx?

Speaker 3

Yes. First question, Michael, there are 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, our capture rate continues to go down in terms of because hospitals are just less likely to use our hub.

Speaker 3

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.

Speaker 3

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 they're just less likely to use our hub and that creates some difficulty in interpreting the information out of the home enrollment data.

Speaker 7

Got it. Very helpful. Thank you.

Operator

Thank you. Next question is coming from Eric Joseph from JPMorgan. Your line is now live.

Speaker 6

Hi, good morning. Just picking up on the plan to adapt for a faster infusion time, just coming out of the ENHANZE updated XTRIMS. 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?

Speaker 6

And would you need to assess more than one infusion per patient as part of that trial like that?

Speaker 2

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

Speaker 2

I think that's what we're our expectations are.

Speaker 6

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?

Speaker 2

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

Speaker 2

But the primary focus is the bioavailability that will tell you how much material you need to load into the injection. 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 three pieces that have to come together.

Speaker 6

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

Speaker 2

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

Speaker 6

Okay. Thanks for taking the questions.

Speaker 2

Yes. Thank you.

Operator

Thank you. Next question is coming from Tara Bankroll from TD Cowen. Your line is now live.

Speaker 8

Hi, good morning. Thanks for taking the questions. 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 and last year with a heavy Q2 and seasonal impacts? Just a bit on how you envisioned near term dynamics here would be really helpful.

Speaker 8

Thanks.

Speaker 2

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

Speaker 3

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.

Speaker 3

We're continuing to do some things

Operator

here and make some investments. And as I mentioned in my

Speaker 3

remarks around patient awareness and As I mentioned, we 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 Granby.

Speaker 8

Okay, great. Thanks. 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?

Speaker 2

Sure. Yes. So I mean, ideally, it would be as 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 anything less frequent that we think would be fantastic.

Speaker 2

And we'll be obviously working toward 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.

Speaker 8

Great. Thanks so much.

Speaker 2

You got it.

Operator

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

Speaker 9

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?

Speaker 3

Yes. Hey, Matt, thanks for the question. We the only compliance numbers that we have or that we've seen 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 were 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.

Speaker 9

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

Speaker 2

practice. When do you

Speaker 9

think you could complete the studies necessary to have that available and update the label?

Speaker 2

Yes. Thanks, Matt. So the goal would be to get those studies started sometime next year. Those studies, again, with enrollment, into a randomized trial of reasonable size, let's say, give or take 200 to 300 subjects. It's going to take at least a year or so.

Speaker 2

You've got a year of enrollment. Follow-up should be short. So we should be able to follow patients and get that data put together pretty quickly and get a filing. And so I think we're even in best case scenario, probably a 2 to 3 year process to get into the label. All right.

Speaker 2

Thanks, Mike. You got it.

Operator

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

Speaker 10

Good morning team. Congrats on a strong quarter and thanks for taking my question. So on the revenue split, if you are able to share between maintenance and maybe new to Biondi patients and if you are able to confirm at what juncture the maintenance patients overwhelmingly take over the new to BHANV patients? And did you comment 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 intracity20 class switch, what percent patients are up for grabs?

Speaker 10

We'd love to hear any perspective on that.

Speaker 2

Sure. Thanks, Matt. Adam, do you want to, can you crack?

Speaker 3

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 are majority, but in the next several quarters, we do expect repeat to increase and become the dominant amount of from the revenue split perspective. I think the second question was share of newly diagnosed.

Speaker 3

Is that right, Mayank?

Speaker 2

Yes.

Speaker 10

That's accurate.

Speaker 3

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 Braille business coming from switches from both OCREVUS and KASIMTA.

Speaker 3

And that has remained pretty steady and consistent since launch.

Speaker 10

Yes, I'll ask that because one of our recent surveys indicated up to 20% of those patients might be up for grafts, hence the question. And then lastly on the Biologics manufacturing expansion implication, are you able to comment on any long term supply goals that you may have in mind between the Korea and U. S. Facilities? Any way to quantify that would be very helpful, Mike.

Speaker 10

Thanks again for taking the question.

Speaker 2

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

Speaker 10

Understood. Thank you.

Operator

Thank you. Next question is coming from Corrine Johnson from Goldman Sachs. Your line is now live.

Speaker 11

Good morning, guys. 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 taking 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?

Speaker 2

Sure. I'll start with the second question. Yes, certainly, we do believe that we can have accelerating new patient starts as we get into 2025. We've always felt that, just generally speaking, the more patients that go on Briohnvy, more patients will go on Briohnvy. So there's definitely sort of a inflection point that comes with that when you have enough people on it and have the critical mass.

Speaker 2

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, whatever 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?

Speaker 2

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 talk a little one about the hospital setting and the percentage of business that comes from hospitals?

Speaker 3

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.

Speaker 3

Today are being treated.

Speaker 11

Helpful. Thank you, guys.

Speaker 2

Thank you.

Operator

Thank you. Next question today is coming from pakar agrawal from Cantor Fitzgerald. Your line is now live.

Speaker 12

Hi, good morning and thank you for taking my questions and congrats on the quarter. Maybe firstly now that Subcutta Kroos 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 start 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?

Speaker 2

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

Speaker 3

Sure. Yes. So, Prakar, 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.

Speaker 3

So no impact as far as we can tell right now.

Speaker 2

And, in terms of allocation of cash, yes, I mean, well, Sean did mention 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 I'd say alluded to in the prior answer, we're committed to expanding the use of Briohnve. So obviously, we're going to be allocating cash toward continuing to build and grow our team, continue 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 'twenty three.

Speaker 2

And I think by the time it gets to 'twenty five, we'll have a pretty healthy marketing budget. So again, I think we're leaning into the opportunity. We see Breomby 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?

Speaker 2

So we're going to be running more likely than not several randomized trials commencing in 2025 for faster infusions, skipping the doses, SUSTRY1 to front end, and of course, sub-two, 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 you mentioned, Azercel 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.

Speaker 2

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 Brianca gets as quickly as possible to that blockbuster level.

Operator

Thank you. Next question is coming from Roger Song from Jefferies. Your line is now live.

Speaker 13

Great. Congrats for the quarter and thank you for taking my question. Most of my questions related to Briandria 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 Briohn B expanding to non MS indication, when you start a trial later this year and then would you be able to give us provide some proof of concept data to support the plan?

Speaker 13

Number 1. Number 2 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? Thank you.

Speaker 2

Yes. Thanks, Roger. So I'll start second since it's the fresh question and I'll work backwards. So the AZERCELL question. Yes, I mean, look, we're hopeful to get that study started later this year.

Speaker 2

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. Let's hopefully get some patients on as quickly as we can. It's logistics of these trials and the ability to put patients on rapidly is not the same as working with other biologics.

Speaker 2

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 not second half of the year. But again, it's hard to really tell how fast we can enroll, although again historically these studies have been rolled 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 and some other areas that we have slated to look into. So TBD on that one, Roger, what could be posted.

Speaker 2

And in terms of the Brionbi 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 plants 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 new information gives us more options to look at and to decide.

Speaker 2

And it's also the thought of whether it's an IV opportunity or potentially subcu opportunity as we 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

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

Speaker 2

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.

Speaker 2

First, expanding our Briohny launch effort, including building out our commercial footprint and increasing our spend in marketing. Next, advancing our BRYONVY expansion initiatives through our subcutaneous development, our ENHANZE SWITCH study and exploring new indications for BRYONVY. And finally, commencing our Phase 1 AZERCELL and 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 healthcare providers that put their trust in TG and BrownBeat and our loyal shareholders for their support. And once again, the whole team at TG for making it all happen.

Speaker 2

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.

Remove Ads
Powered by Quartr
Earnings Conference Call
TG Therapeutics Q3 2024
00:00 / 00:00
Remove Ads