Q3 2024 TG Therapeutics Inc Earnings Call
[music].
Greetings and welcome to the TG Therapeutics third quarter 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.
Maybe placed in the question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Jenna Bosco. Please go ahead.
Thank you welcome everyone and thanks for joining us this morning, I'm, Jenna Bosco and with me today to discuss the third quarter 'twenty 'twenty four 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 D.
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 disclaim any obligation to update or revise any forward looking statements. This conference call is being recorded for audio rebroadcast on Tg's web site Www Dot TG therapeutics Dot 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.
Mike Weiss: Thank you Janet and good morning, everyone. Thank you for joining us for our quarterly earnings call.
Cited to share with you the results of another quarter of growth.
And execution of our brand relaunch.
The positive feedback and uptake in the marketplace.
Mike Weiss: He used to outpace our expectations.
The strong data presented during the annual <unk> meeting.
Ultimate one and two trials and the enhance phase III trial evaluating an individual's with relapsing forms of M. S.
Mike Weiss: He used to strengthen our belief in the long term value of ground beef.
We remain highly focused on the commercial success of branding and I am excited to share with you our current progress.
Mike Weiss: As well as our future plans to continue to grow very upbeat and shareholder value.
Mike Weiss: Let's kick things off with a brief review of the quarterly shelves.
I'm happy to report that the third quarter U S. Net sales were $83 3 million.
Mike Weiss: Adam Waldman, our chief commercialization officer will join shortly to provide a full commercial update and ear in guidance, but I want 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.
We ended the year and into 2025.
Mike Weiss: And further toward our long term goal of becoming the number one prescribed anti CD 20 in terms of dynamic market share.
Mike Weiss: To that end, let's discuss some of the data presented at the recent <unk> annual meeting.
Mike Weiss: As I alluded to earlier, we presented two important datasets during the meeting the first was a long term follow up data from our open label extension study.
Mike Weiss: Oh from the ultimate one and two phase three trials, which as a reminder for the core trials that supported the approval of reality for individuals with relapsing forms of image.
Mike Weiss: After five years or beyond retreat, and 92% of patients were free from disability progression.
And in the fifth year of treatment.
Mike Weiss: And how do you realize you read a lot trading point zero to.
Mike Weiss: I wasn't sure.
Mike Weiss: Which is equivalent to one relapsed occurring every 50 years of treatment.
Mike Weiss: And importantly, the overall safety profile remains consistent over five years of continuous spray on b treatment with no new safety signals emerging with prolonged usage.
Mike Weiss: As we've stated previously we believe we have set the standard for convenience and IV CD 20 therapy, we continue to look for ways to further streamline patient experience.
Mike Weiss: An extra range. The updated data previously presented an in April from our enhance study showing that individuals with relapsing forms an M S.
Mike Weiss: Or b cell depleted on their current anti CD 20 therapy and were switched cipriani.
Mike Weiss: Well to tolerate one hour bring him be infusion without first receiving for our introductory dose.
Mike Weiss: Currently all IV C D twenty's used to treat that mess required two infusions and the first two weeks to initiate therapy.
Mike Weiss: This approach would only require a one visit to stark reality.
<unk>, we presented data for the first time, I think faster 30 minute free on the infusion from our enhance trial.
Mike Weiss: Data presented while still preliminary so that the first maintenance dosing.
Mike Weiss: Given as a 30 minute infusion as opposed to one hour was well tolerated with all infusion related reactions being mild grade one and resolved completely.
We have now treated over 50 individuals with RMS with 30 minutes.
Mike Weiss: I look forward to presenting updated data at a future medical conference.
Mike Weiss: 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 ground beef.
And maintain what we believe is a best in class profile.
Okay.
Mike Weiss: And further to achieving that goal I'd like to remind everyone that we are also developing a sub Q version of branding.
While the majority of individuals' with M. S choose I V. C. D 20 delivered every six months, which has helped Biamby's currently offered and we expect that to continue the at home self administered subcutaneous kit is meaningful.
Mike Weiss: Accordingly, we believe that offering an at home suffered self administered subject reality would open up a new market opportunity for us.
Mike Weiss: We expect to be able to provide an update from our pre M. B sub Q bioequivalence study by early next year and if all goes well we'd be targeting a pivotal trial commencing in the middle of 2025.
Mike Weiss: And finally bring them beyond three M. B on the R&D front, we previously shared that the U S. FDA has cleared our investigational new drug application I N D for as yourself an off the shelf Allergan. The CD 19 car T cell therapy for the treatment of autoimmune diseases.
Mike Weiss: The team has been working hard to move this forward and we are targeting launching a phase one study around the end of this year or early next year.
Mike Weiss: <unk> and individuals with progressive and that's it.
Mike Weiss: An exciting new opportunity that we believe may offer a new treatment for individuals with progressive M. S 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 briana at Samsung Biologics and South Korea.
Mike Weiss: Who are recognized as the global leaders in biologics manufacturing.
Mike Weiss: Who have been and continue to be a great partner to T. G.
Mike Weiss: That's gonna be continues to grow as you continue to believe.
Mike Weiss: Buster potential a grounding from a risk management standpoint.
Mike Weiss: We felt it was time to engage a secondary manufacturer ramping.
Mike Weiss: Accordingly, we are happy to announce we are secure.
Mike Weiss: Did you film Donaldson's Biotechnologies.
Mike Weiss: Second manufacturer around me.
Mike Weiss: Silly based here in the United States.
As we continue to expand our commercialization efforts and M S.
About the future of Brandy. We believe this is an important next step that will continue to support our growth plans and provide additional security for our drug supply.
Mike Weiss: In closing I want to thank all of our T. G ears for their hard work and commitment to people living with M. A S.
Our progress is a testament to our collective efforts and I'm excited about the path forward.
Mike Weiss: Through your efforts T. G is poised to become a new leader in the Ms market focus on developing and delivering innovative therapies for multiple sclerosis.
Speaker Change: With that I'll hand, the call around a Mormon our chief commercialization officer to walk you through our commercial performance in more detail.
Speaker Change: Adam go ahead.
Yeah. Thank you Mike I'm excited to share the continued commercial success with experience with reality.
Mike Weiss: And the steps, we're taking to drive future long term growth.
Mike Weiss: Since its launch <unk> has consistently exceeded our expectations with Q3, marking another strong quarter of sequential revenue growth.
Mike Weiss: As Mike mentioned, we achieved second quarter net sales of $83 3 million, reflecting approximately 15% quarter over quarter growth in over 230% growth from the same quarter last year.
Mike Weiss: Solidifying Brown B is the fastest growing DMT in the U S that mass market.
Mike Weiss: And while we did observe some expected summer dynamics in the third quarter.
We're 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 record enrollment month.
We continue to see steady growth in new prescribers and treatment centers now, reaching nearly 1100 prescribers.
Mike Weiss: Across approximately 600 centers, including 95% of the top 100 M S centers since launch.
Encouragingly two thirds of the new prescribers in Q3 came from the hospital setting.
Mike Weiss: Which is now our fastest growing segment and account for approximately 55% of our overall business.
We continue to believe in Brown these best in class profile, including its high level of efficacy.
Well established safety profile.
And a one hour infusion every six months attributes, which we believe strongly resonate with health care providers looking for a convenient yet highly effective treatment option.
Mike Weiss: We were particularly excited to see the overwhelming positive response from reality at the <unk> Conference in September.
As Mike mentioned rally was featured prominently in 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.
Mike Weiss: First we believe the enhanced trial, which showed the potential for <unk> to have a rapid 30 minute infusion could rapid represent a significant enhancement to our profile.
Mike Weiss: Secondly, it has trial show the potential to switch from a CD 20, chip reality without requiring a loading dose.
Mike Weiss: We believe this will make a switching potentially easier for many patients who may not be satisfied with their current CD 20 therapy.
And finally, the open label extension presentations underscore to bring on these long term efficacy and safety.
Mike Weiss: Enforcing its potential best in class profile, the data demonstrated an impressive annualized relapse rate at this 0.0 to five years equivalent to one relapse for 50 patient years.
Along with consistent five year safety data.
Mike Weiss: We believe this information reinforces the value proposition and will particularly resonate with physicians and patients who seek established long term data before adopting and therapies.
Mike Weiss: The visibility and recognition we received it extra have certainly strengthened our confidence in its long term positioning.
As the preferred anti CD 20 therapy in relapsing forms of M. S.
Another contributing factor to free him. He's growing success is the expansion of our commercial infrastructure.
Excuse me over the last few years, we've nearly doubled our commercial field team ensuring that we can adequately support the rising demand for reality and increase our reach within key M. S treatment centers.
Mike Weiss: And that 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 brand new product profile.
Alongside the commercial team expansion. We have also started to increase our investments in patient awareness recognizing that inform patients often key drivers and treatment decisions. We have launched targeted awareness campaigns aimed at educating patients on the benefits of Brown V.
Mike Weiss: These campaigns are aimed at aimed at empowering patients to have informed discussions with their health care providers.
Mike Weiss: We believe that by raising awareness directly among patients we can further accelerate adoption and ensure that more individuals living with relapsing forms of Ibs D.
Benefit from Brown these unique profile.
Mike Weiss: 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.
Mike Weiss: In 2025 and beyond.
Speaker Change: Uh huh.
Since launch we've made significant strides in insurance Brown, b, and ensuring brumbies availability and access as I mentioned previously this has always been a prioritize area for us and we were pleased that we maintain 95% coverage with national and regional payers.
Additionally, our team is doing an exceptional job facilitating the reimbursement process.
Working with customers and patients to make sure patients can access brown.
Speaker Change: We have worked diligently to streamline the patient journey, ensuring that is accessible with minimal delay.
Which has helped sustain our patient adherence and satisfaction are time to infusion continues to decrease and our persistence and our persistence at week 24.
Speaker Change: <unk> continues to exceed our expectations.
Speaker Change: Our performance this quarter reinforces our belief that brumbies profile continues to resonate in the market and our commercial organization is very capable of continuing to look 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 <unk>.
Speaker Change: 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.
Speaker Change: 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 <unk> into a blockbuster brand.
In conclusion I want to thank our team for their dedication their hard work their outstanding efforts are contributing to the positive experience with branding and confidence in our organization.
Want to thank the health care providers and their patients.
But theyre trusting TG therapeutics together, we will continue to improve outcomes for those in need we certainly have more work to do but we're focused on extremely motivated to continue to work every day to bring beyond me to those living with MFS and their families.
Speaker Change: With that I'll turn the call over to Sean power our CFO.
Yeah.
Sean Power: 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 and media section of our website.
Sean Power: This morning, I'll start by highlighting our Q2 revenue as Adam detailed earlier, we were pleased to report third quarter <unk> net product revenue of $83 3 million for the three months period.
Our year to date nine months <unk> 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 three and nine months nine months periods ending September 2024.
Sean Power: For the three months ended September 30th 'twenty 'twenty four our GAAP net income was approximately $3 9 million or two cents per diluted share.
Sean Power: When excluding non cash items net income for the three months period was approximately $15 7 million.
Sean Power: Our opex during the quarter, excluding noncash items came in at the low end of our guided range at approximately $50 million.
Sean Power: Our opex for the first nine months of 2024 is approximately 155 million and.
Sean Power: And for the full year, we expect our opex to come in well below the guidance of approximately $250 million.
Sean Power: And finally, I'll close by touching briefly on our cash position.
Sean Power: We ended the third quarter with approximately 341 million in cash cash equivalents and investment securities.
Sean Power: Which we believe provides us with a strong financial position to support the commercialization of research and development efforts and our continued business operations for the foreseeable future.
Sean Power: On a related note I'd like to briefly touch on our share repurchase program, which we commenced during the third quarter.
Sean Power: We began slowly buying shares back during the third quarter and will continue with a measured approach for the foreseeable future.
Sean Power: 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.
Sean Power: With that I'll now turn the call back over to the conference operator to begin the Q&A.
Speaker Change: Thanks to now be conducting a question answer session, if you'd like to be placed in the question queue. Please press star one on your telephone keypad.
Speaker Change: As you. Please ask one question one follow up then return to the queue. Once again Thats star one to be placed into the question queue. Please ask one question and one follow up then return to the queue for participants using speaker equipment may be necessary to take yourself off speaker phone before pressing star one.
Speaker Change: Our first question today is coming from Ed White from H C. Wainwright Your line is that life.
Sean Power: Yeah.
Ed White: Good morning, Thanks for taking my questions.
Ed White: First I wanted to ask a big picture question.
Sean Power: You mentioned in the press release that you expect to see continued growth in 2025.
Sean Power: Wanted to get your thoughts on the size of the anti CD.
Sean Power: 20 market in M. S. In 2025, and your thoughts on market share not only for a.
Sean Power: B M D, but also I V versus sub Q.
Speaker Change: Thanks for the question Adam you want to take a crack at that one.
Speaker Change: Sure. Good morning, I am sure for so Big picture I mean, we see CD 20 are continuing to grow.
Speaker Change: It's in the low 50% of dynamic share today, we see no reason that that can't continue to grow too.
Sean Power: Mid fifties to even 60%.
Sean Power: You know I think the momentum continues behind the class.
Sean Power: As far as our market share.
Sean Power: Growth were about 15% of the no CD 20 market today, and we think we have a lot of room to grow.
Speaker Change: Okay. Thanks, and just a question on the announced.
Speaker Change: Would you build a secondary U S based manufacturing your gross margins have been pretty consistent this year quarter over quarter well. This agreement have any impact on gross margin going forward.
Sean Power: Shawn when I talk about.
Speaker Change: Yeah. Thanks for the question.
Speaker Change: In the near term are absolutely not I will have some uptick upfront expenditures associated with that but that will of course run through our R&D and in the in the long term, we think our gross margins would would remain consistent so a short answer to your question no no real impact on gross margin.
Sean Power: Yep.
Sean Power: And I forgot to answer one part of your question, which was the IV to sub Q.
Sean Power: You know, we we we believe it's around 70% Ivy the sub Q.
Sean Power: In terms and we do still believe it is as Mike said in his remarks.
Sean Power: The clear patient preference today, and we see that continuing.
Speaker Change: Great. Thanks, Adam and thanks to everyone congratulations on the quarter.
Speaker Change: Makes sense.
Speaker Change: Thank you next question is coming from Michael Difiore from Evercore ISI. Your line is now live.
Michael DiFiore: Hey, guys. Thanks, so much for taking my question and congrats on the quarter.
Michael DiFiore: Two from me were there any inventory channel dynamics during <unk> and separately.
Speaker Change: What was a T Rx script count in <unk> and how many new patient scripts had been received in the hub I noticed that wasn't included in your in your print. This morning. Thank you.
Speaker Change: Alright, Thanks for the question Adam.
Speaker Change: And then the inventory in Terex.
Speaker Change: Yes. The first question Michael there's there no. She knows no changes in inventory in the quarter are all distributors are at normal inventory levels.
Speaker Change: And then as far as the the enrollments.
Speaker Change: We.
Speaker Change: We're going to move away from 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.
Sean Power: Because hospitals are just less likely to use our hub.
Sean Power: We just don't think that this is going to be a an accurate measure going forward. Yeah, I think directionally. It can help them certainly, but I think in sort of using it as a way to sort of garner whether we're growing or not growing as it does with the capture rate fluctuating in more and more hospitals coming into play that are there are certainly just not.
Sean Power: Using it we.
Sean Power: 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 we had a much higher percentage of our business coming from private practices.
Speaker Change: Use the hub much more consistently.
Sean Power: It was a good measure as we continue to go out here.
Sean Power: As more I said in our remarks about 55% of our business that was coming from hospitals is the fastest growing of our segment and they're just less likely to use our hub and that create some some difficulty in interpreting the information out of the home enrollment data.
Sean Power: Yeah.
Speaker Change: Got it very helpful. Thank you.
Speaker Change: Thank you next question is coming from Eric Joseph from JP Morgan. Your line is now live.
Eric Joseph: Hi, good morning.
Eric Joseph: Just just picking up on the.
Sean Power: Yeah.
Sean Power: Sure.
Eric Joseph: The plan to.
Sean Power: For a faster infusion times.
Sean Power: Just coming out of the.
Sean Power: The.
Sean Power: Enhanced updated extras.
Speaker Change: Can I get you to elaborate a little bit more on sort of what you might.
Sean Power: Might be needed to support on label indications for.
Sean Power: Either a shorter infusion or skipping a loading dose or switch patients you mentioned, possibly needing randomized data.
Sean Power: With the focus therapy.
Sean Power: Safety and <unk>.
Sean Power: Would you need to assess more than one.
Sean Power: Infusion.
Sean Power: Per patient as part of that Oh.
Sean Power: That's why I like that.
Speaker Change: Yeah. Thanks for the question Eric So the answer to the last part of your question, we need more than one infusion.
Sean Power: He's probably unclear today, but I don't think so I don't think we'll need more than one infusion for patient to to tell on the safety and and yes, It's primarily a safety study.
Sean Power: Hmm.
Sean Power: Yeah sure.
Sean Power: For faster infusions.
Sean Power: Historically when you.
Sean Power: They've been done before with other companies and they do require a randomized trials and they usually are looking at safety and Tolerability.
Sean Power: That's what we're all expectations are.
Sean Power: Okay.
Speaker Change: Okay, Great and maybe a quick follow up if I could with respect to the sub Q.
Sean Power:
Sean Power: Initiative can you talk a little bit about sort of what you are tracking.
Sean Power: In addition to safety to kind of verify.
Sean Power: Or sort of assess.
Sean Power: Oh.
Sean Power: How long of a dosing interval you could ultimately move forward with a pivotal study.
Speaker Change: Yeah, So again with that with what you were looking at primarily the bio equivalents. So again, it's just the amount of material required to match the PK.
Sean Power: And yes that will determine the tolerability of the materials.
Sean Power: To put too much in.
Speaker Change: <unk> looked at some point start to see a deterioration in tolerability at the injection site.
Sean Power: But the primary focus is.
Sean Power: Bioavailability that will tell you how much material you need to load into the.
Sean Power: The injection.
Speaker Change: That will ultimately as you mentioned impact how tolerable it is so.
Speaker Change: It's all of those pieces will come together at some point soon.
Speaker Change: And like I said to be able to share that data early next year.
Speaker Change: But those are basically the three pieces that have to come together.
Speaker Change: Is there a PD component are you looking at sort of the Beast.
Speaker Change: So decline.
Speaker Change: Uh huh.
Speaker Change: Yeah, I can I can share with you that you saw decline is not an issue in any real dose level.
Speaker Change: Okay.
Speaker Change: Thanks for taking the questions.
Speaker Change: Yeah. Thank you.
Speaker Change: Thank you next question is coming from Tara Bancroft from TD calendar. Your line is now live.
Tara Bancroft: Hi, good morning, Thanks for taking the question so thinking about your guidance. It assumes just over or I guess, just under 20% sequential growth and that's that's incrementally higher than the 15% from Q3, but I was wondering looking ahead now should we assume steady growth like this.
Sean Power: From here on out or a similar cadence of growth I can.
Sean Power: In 2025 like you saw this year and last year with a heavy Q2 and and and seasonal impacts just just a bit on how you envision near our near term dynamics here would be really helpful. Thanks.
Speaker Change: Sure. Thanks, I didn't want to talk alone.
Sean Power: Yeah.
Speaker Change: Sure Yeah. Thanks for the question Sarah I mean, we tried to provide the best information we have when when we have it I think the guidance is strong and showed sequential revenue growth.
Sean Power: We're continuing to do some things here in and make some investments and as I mentioned in my remarks around patient awareness and and other things that we are hoping will continue to do so.
Sean Power: Fueled the trajectory of the growth of this product.
Sean Power: As I mentioned we.
Sean Power: We think we're poised to make this a blockbuster brand.
Sean Power: And that trajectory I think there are seasonal if you look at the EMS market in general there are some quarterly season.
Sean Power: Dynamics that are in play.
Sean Power: You know as I mentioned in Q3, there were there were some in just the summer months.
Sean Power: You know that can affect the exact line, but but I think we are poised to grow more we're doing things in the market that are they're getting traction and we're very excited about what the future is for brandi.
Speaker Change: Okay, great. Thanks, and just a quick follow up on on the previous question about sub Q you know I understand you you mentioned a lot of expectations, there, which is helpful. But can you tell us.
Sean Power: What volume and perhaps dosing interval that you're ideally targeting with with the sub Q formulation.
Speaker Change: Sure Yeah, so I mean, ideally it would be as less frequently as possible.
Sean Power: I think sort of a minimum bar.
Sean Power: It would be certainly every other month I think is the minimum bar that we're targeting.
Speaker Change: Less frequently and that could be fantastic honestly working towards that of course, but.
Speaker Change: Oh, no no promises, but you got that.
Sean Power: The minimum profile I think would be every other month was the target for that.
Speaker Change: Great. Thanks, so much.
Speaker Change: You got it.
Sean Power: Okay.
Speaker Change: Thank you. Our next question today is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.
Matt Kaplan: Hey, good morning, guys and congrats on the quarterly results.
Matt Kaplan: I guess for Adam can you.
Sean Power: And on the rates of persistence youre seeing and how it compares to other therapies in this space.
Speaker Change: Yeah, Hey, Matt Thanks for the question.
Sean Power: We.
Sean Power: The only.
Sean Power: Clients numbers that we have or that we've seen that are published or are with the other IV <unk> 20, a competitor.
And we're doing you know so that that's been sort of our benchmark.
Sean Power: And you know what we were expecting and we continue it looks like and again you know, we're continuing to collect data, but it looks like we're doing at least as good if not better.
Sean Power: On the week 24 compliance than what's out there and published.
Speaker Change: Okay, Great and just a follow up on the enhanced stat on the questions with respect to when you could see that incorporated into clinical practice.
Speaker Change: When when do you think you could complete the studies necessary to have that available and update the label.
Speaker Change: Yeah. Thanks, Matt.
Speaker Change: So the goal would be to get those studies started sometime next year.
Speaker Change: And studies again with enrollment.
Speaker Change: A randomized trial of reasonable size.
Speaker Change: Give or take 200 to 300 subjects.
Speaker Change: You can take at least a year or so you've got a year of enrollment.
Speaker Change: Follow up should be short, so we should be able to choose.
Speaker Change: It's all of the patients and get that data put together pretty quickly and get a filing done so.
Speaker Change: Even in the best case is probably a two to three year process to get it into the label.
Alright. Thanks.
Speaker Change: Thanks, Mike.
Speaker Change: You got it.
Speaker Change: Thank you next question today is coming from my own Honey from B Riley Securities. Your line is now live.
Speaker Change: Good morning team congrats on a strong quarter and thanks for taking my question. So.
Speaker Change: The.
Speaker Change: Revenue split if you will at least 17, maintaining and maybe need to DMD patients in.
Speaker Change: And if you as I do confirm that.
Speaker Change: One juncture it or you know the main dan's patients older than me.
Speaker Change: They can be filled with the need to DMD patients.
Speaker Change: And did you comment on Asia and 70.
Speaker Change: Sure for near the CD 20 wishes newly diagnosed.
Speaker Change: On an as stations and and we'd love to hear any any color you are seeing in the marketplace.
Speaker Change: And then the interests you need 20 class a switch what percent attrition set up for grabs.
Speaker Change: We'd love to hear any perspective on that.
Speaker Change: Sure. Thanks, Matt.
Speaker Change: Uh huh.
Speaker Change: You're correct.
Speaker Change: Yeah, Yeah as far as the first question.
Speaker Change: The revenue split is it still mostly new versus repeat but we do expect.
Speaker Change: In the next several quarters that that will turn upside down right repeat.
Speaker Change: Prescriptions will start to be the.
Speaker Change: The lion's share of the.
Speaker Change: Of the infusions going you know in the next couple of quarters as we continue to stack.
Speaker Change: The stacking effect and we continue to get patients coming back for a week 48, and so on and so forth. So.
Speaker Change: But today, it's still news the other majority, but in the next several quarters, we do expect repeat too to increase and become the dominant amount of from a revenue split perspective.
Speaker Change:
Speaker Change: I think the second question was share of CD newly diagnosed is that is that right Mike.
Speaker Change: Yeah.
Speaker Change: Yeah, Yeah that decade.
Speaker Change: Yeah, Yeah, we haven't provided shares in in newly diagnosed or new to see 'twenty. We haven't provided those shares and then your you know your third question.
Speaker Change: Was about switching.
Speaker Change: And we do see we continue to see.
Speaker Change: A sizable portion of our.
Speaker Change: Of our <unk> business coming from switches from both of us and cause them to and that has remained pretty steady and consistent since launch.
Speaker Change: Yeah, I'll, just add to that what about eastern surveys indicated up to 20% of those patients might be up for grabs.
Speaker Change: Hence the question and then lastly on the biologics manufacturing expansion implication are you there.
Speaker Change: Could you comment on any.
Speaker Change: Long term supply go that you may have in mind between Korea and U S facilities.
Speaker Change: Any way to quantify that can be helped in Mike. Thanks again for taking the question.
Speaker Change: Yeah. So.
Speaker Change: I don't think we have a good launch at this moment on my end, but obviously were.
Speaker Change: Were securing what we think that was what was required for a long term supply.
Speaker Change: Between both of our Samsung and passion.
Speaker Change: C G.
Speaker Change: Understood. Thank you.
Speaker Change: Thank you next question is coming from Corinne Johnson from Goldman Sachs. Your line is now live.
Corinne Johnson: Good morning, guys.
Corinne Johnson: Maybe a couple from US you talked about the bulk of growth.
Corinne Johnson: Your patient, let patients coming from the hospital setting I guess remind us what portion of MF patients are taking care of their end and why do you think that that's such a good source of new patient growth for you all.
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 and tier three as you get kind of like well into the launch here.
Speaker Change: Sure I'm sorry, the second question, Yeah, and certainly we do believe that the kind of accelerating new patients starts as we get into 2025, we've always felt that just generally speaking the more.
Speaker Change: Patients that go on Brownsea more patients will go on beyond me. So there's definitely sort of a inflection point that comes with that when you have enough people on it and.
Speaker Change: 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 wherever whenever and how many patients that may be.
Speaker Change: We've expanded the size of our commercial team, we're expanding our our marketing efforts coming into 2025.
Speaker Change: So yes, I mean is it possible honestly can't promise sentiment I don't think the.
Speaker Change: 15% to 20% quarter over quarter of steady growth that we've had thus far as well.
Speaker Change: Problematic I think it's pretty darn good and we will continue to bring us to a blockbuster within a.
Speaker Change: Short amount of time, but yes, I think it is also possible that the growth rate could accelerate as we get into 2025.
Speaker Change: I didn't want to tackle the one about the hospital setting.
Speaker Change: Jim.
Speaker Change: It comes from hospitals.
Speaker Change: Yeah, Yeah, so so corinne it's.
Speaker Change: It's.
Speaker Change: It was probably 60% to 65% of patients are being seen in the hospital setting. That's why we're we think are having continued expansion into that hospital segment is encouraging.
Speaker Change: And it is now the fastest growing segment.
Speaker Change: As I mentioned in my prepared remarks.
Speaker Change: And it is where the majority of the patients in the U S. Today are being treated.
Speaker Change: That's helpful. Thank you guys.
Speaker Change: You can't.
Speaker Change: Thank you. Your next question today is coming from.
Speaker Change: Although off from Cantor Fitzgerald your line is that right.
Speaker Change: Hi, Good morning, and thank you for taking my questions and congrats on the quarter, maybe firstly now that subdued oak. Louis has launched what are you seeing on the ground in terms of it it's gaining more share from even call it digitally and the second question.
Speaker Change: 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 any other a mechanism to kind of explore on the capital allocation front.
Speaker Change: Sure. Thanks, Patrick.
Speaker Change: I don't even want to.
Speaker Change: I'm talking about are we seeing any competitive dynamics in the market recently.
Speaker Change: Sure.
Speaker Change: Yeah. So thanks for the question are we.
Speaker Change: We've seen no impact from from Okra with Lenovo to date.
Speaker Change: We had as I mentioned in the prepared remarks, we had the best month of enrollments.
Speaker Change: Ever in October.
Speaker Change: So no no impact.
Speaker Change: As far as we can tell right now.
Speaker Change: And in terms of the allocation of cash yeah.
Speaker Change: Well, Sean had mentioned 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 yeah. We do believe we'll be allocating overtime more cash to share buybacks, but in addition, you know as Adam again in his prepared and.
Speaker Change: I am saying.
Alluded to in my prior answer.
Speaker Change: We were committed to expanding the.
Speaker Change: The use of Brown V a.
Speaker Change: So obviously, we're going to be allocating cash towards continuing to build and grow our team.
Speaker Change: Continuing to build and grow our marketing efforts are.
Speaker Change: Which you know as everyone Who's followed us closely knows we started out with a pretty modest.
Speaker Change: Marketing budget, when we launch in 'twenty, three and I think by the time. It gets 25 will have a pretty healthy marketing budget. So again, I think where we're leaning into the opportunity we see on the as a blockbuster.
Speaker Change: Blockbuster brand and you're going to make sure we try to get there as quickly as we can so you'll be using cash in investing in those activities.
Speaker Change: And as part of that again, we'll be investing in our 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.
Speaker Change: Skipping doses a stream on the front end and of course sub too which is obviously the highest of the priorities of that group and so.
Speaker Change: We're going to make investments in those as well so that's where some of the excess cash goes obviously as we mentioned as yourselves moving forward and we're excited about the potential there and then lastly, our eyes are appeal, then and our business development program is active and if we see something that we think really augments and complements what we're doing.
Speaker Change: We're going to we're going to make investments there as well. So I think we've got plenty of potential uses for the excess cash flow, but we're and we're not dogmatic about how it gets spent except I'd say on the front end with the.
Speaker Change: Investments in and making sure Brownsea gets as quickly as possible to that blockbuster level.
Speaker Change: Okay.
Speaker Change: Thank you. Your next question is coming from Roger song from Jefferies. Your line is now live.
Great Ah congrats for the quarter and thank you for taking my question. Most of my question relates to your Brown, Yeah, Nah I'm first and then maybe just a follow up on the capital allocation and of course those are additional.
Speaker Change: Pipeline. So one is.
Speaker Change: Our insurance of that reality, expanding qunar en masse indication when you start a trial needed. This year and then would you be able to give us provides them a.
Speaker Change: Proof of concept data to support a pad number one number two at each end of the allogeneic cell therapy.
Speaker Change: Do you expect to give us some data update next year and then what would be that.
Speaker Change: It won't be that that principle to share the data in terms of the number of patient in tandem are trickier the data. Thank you.
Speaker Change: Yeah. Thanks, Roger So I'll start second.
Speaker Change: The fresh question and I'll work backwards, so the ease yourself question.
Speaker Change: Yeah, I mean look where we're hopeful to get that study started.
Speaker Change: Later in this year. So we've got two months left to to put our first patient in if not it'll be early next year.
Speaker Change: The cadence of data coming out of that trial I think is yet to be determined yeah. Okay.
Speaker Change: Okay.
Speaker Change: Hopefully get some patients on as quickly as mechanics.
Speaker Change: The logistics of these trials and the Adobe put patients on rapidly.
Speaker Change: It's not the same as is working with other biologic so.
Speaker Change: But if we can get you know a decent number of patients on as quickly as we can hopefully we can get some data out.
Speaker Change: Next year, but I wouldn't anticipate.
Speaker Change: You know any available data until the second half and more likely than not a 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.
Speaker Change: Let's let's keep a hopeful I on that because I do think it has a lot of promise in the areas in which.
Speaker Change: We intend to study, particularly progressive that mass in some other areas and we have slated tend to look into so.
Speaker Change:
Speaker Change: T D D on that one Roger we'll keep you posted and in terms of the brown on the outside and that's plan a.
Speaker Change: Yeah, I can say from the beginning of the year. We did note that that was probably the lowest of our of our near term interest and priorities. I think we are working toward getting some patients on non MFS indications before the end of this year still.
Speaker Change: And we can report on that if and when it happens.
Speaker Change: I think part of the challenge in our plants outside of M. S right now.
Speaker Change: Oh really.
Speaker Change: With all of the options I mean, there's been so much new C.
Speaker Change: <unk> 'twenty in B cell data, that's come out across multiple disease areas.
Speaker Change: And then we've been really.
Speaker Change: <unk> taken our time.
Speaker Change: This before but with new information it gives us more options.
Speaker Change: Two to look at and decide and it's also.
Speaker Change: The thought of whether it's an.
Speaker Change: And Ivy opportunity or potentially sub two opportunity as you move into some of these other indications. So I don't I don't have any specifics to discuss today, but it is definitely on the radar screen teams working on them.
Speaker Change: Putting non MF patients into trials this year.
Speaker Change: And the commercial team certainly is helping us to evaluate.
Speaker Change: What the next best indications are going to be.
Speaker Change: And I'm, assuming a 2025, Oh, we'll talk more about that and we'll get that up and running.
Speaker Change: Thank you we've reached out of our question and answer session I'd like to turn the floor back over for any further or closing comments.
Speaker Change: Great. Thank you and thanks again, everyone for joining us on today's call. We look forward to continuing the positive momentum until the end of the year and into next year and as discussed today will continue to be focused on several key priorities first expanding our purion XE launch effort, including building out our commercial footprint and increasing our spend in marketing.
Speaker Change: Your.
Speaker Change: Next advancing our ground the expansion initiatives of our subcutaneous development arm and switch study and exploring new indications for browsing and finally commencing our phase one either sell in progressive Ms as well as looking at opportunities to expand our pipeline.
Speaker Change: With that I'd like to close by thanking those with M. S N. Their health care providers have put their trust in T. G M Brown, b and our loyal shareholders for their support and once again the whole team that can do something that'll happen have a great day.
Speaker Change: Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you.
Speaker Change: You for your participation today.