TG Therapeutics Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 28, 2024

There are 12 speakers on the call.

Operator

Greetings, and welcome to the TG Therapeutics 4th Quarter and Year End 2023 Financial Results and Business Update Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco.

Operator

Thank you. 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 Q4 year end 2023 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 an overview of our financial results before turning the call over to the operator to begin the Q and A session. Before we begin, I'd like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1

These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory 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.

Speaker 1

This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where we'll be available for the next 30 days. Now, I'd like to turn the call over to Mike Weisz, our CEO.

Speaker 2

Thanks, Jana, and good morning, everyone. Thanks for joining us on today's call. 2023 was a transformational year for TG. We kicked off the year with the launch of Riemmi for relapsing forms of multiple sclerosis towards the end of January and saw a nice sales momentum carried throughout the year resulting in approximately $90,000,000 in U. S.

Speaker 2

Briohnve net revenue for our 1st partial year of sales. We believe these 1st year revenues speak to the high level of early interest and strong underlying demand for BRYONV and we look forward to continued carry through in 2024 where we are targeting $220,000,000 to $260,000,000 in U. S. Sales revenue. The feedback from physicians, patients, nurses and infusion centers continues to be very positive and drives our confidence in both the short term revenue ramps ramp as well as the long term blockbuster potential of Breomvieve.

Speaker 2

Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 by dynamic market share perspective and the early update supports our belief that that is possible. Having said that, this is a competitive market and Briomvii is the newest entry. So differentiation matters. One obvious difference is that BIOMBI is the only anti CD20 monoclonal antibody that can be given as a 1 hour infusion every 6 months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites. Beyond the 1 hour infusion, we are excited to continue to explore biological based differences that may not be as readily apparent, but are perhaps clinically relevant.

Speaker 2

As a reminder, Briohnvy is differentiated by design, having been glyco engineered for enhanced immune effector cell engagement and efficient D cell depletion. Preclinical data demonstrates that compared to the other anti CD20s approved or used to treat MS, 3 only has the highest binding affinity to CD20, the target for these types of drugs performed on B cells and through which glycoengineering has the ability to induce the highest level of antibody dependent cellular cytotoxicity regardless of patient specific polymorphisms. Whether or not these biological attributes of Briohn B have clinical relevance in patients with MS has not yet been determined as no head to head trials have been conducted for Briohn B versus the other anti CD20s. However, what has been well established is that Brehombe is the only anti CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in Phase 3 trials. Also in clinical trials, Ryomby rapidly depleted B cells with a median of 96% reduction within 24 hours and 95% on time infusion completion rate, which we believe speaks to the tolerability profile of Briomdi.

Speaker 2

As we move forward, we are eager to explore to what degree the design attributes of Briomdi may be contributing to the robust activity seen. We plan to do more work to evaluate some of these unique attributes and to understand whether the molecular and non clinical differentiation translates into clinical differences. And we look forward to sharing more on that when available. I also wanted to highlight another recent exciting development. We were pleased to share yesterday that in addition to our current Briohnve patent and U.

Speaker 2

S. Biologics exclusivity, The U. S. Patent and Trademark Office recently issued 3 additional patents for Breombee, including a composition of matter patent related to the glyco engineered attributes of BRYONV. With these additional patents, our patent protection now extends through 2,000 and 42, providing us a nice long runway to continue to explore the full potential of Breomvian, including expanding the potential reach of Breomvian MS as well as into other autoimmune diseases, which is a good segue to discuss what is next for Breomby and TG.

Speaker 2

First, let me say that the U. S. Breomby launch and commercialization is and will remain our highest priority. That said, our drug development team is poised and ready to potentially drive additional value through Breomby lifecycle management activities as well as new drug development. More specifically, we are focused in 4 key areas.

Speaker 2

1st, in making IV Brijunve even more convenient. Last year, we presented the first data from the ENHANZE Phase 3b trial of which the goal is to evaluate the safety and efficacy of eliminating the 4 hour BRYOMV 150 milligram starting dose for patients who are switching from a prior CD20 and have a pre specified low level of B cells. Early safety data from this study is encouraging and we look forward to presenting additional safety and efficacy data this year, including at the ACTRIMS conference, which is happening later this week. A second key area for us is developing subcu Briohnvy. We have completed our preliminary subcu formulation and are preparing to enter human bioequivalence studies this year.

Speaker 2

We believe this subcu market could represent a significant new market opportunity for us as the IV and subcu CD20 markets within RMS are rather distinct. Given the known profile of the currently available subcu and the profile of the other one under development, we believe there is plenty of room to strive to develop a potentially best in class subcu CD20 product. 3rd, we are looking forward to extending Briohnvia beyond MS. There are multiple other disease indications where CD20s have proven to have utility. We look forward to launching our first autoimmune trial outside of MS this year.

Speaker 2

And 4th and finally, we are focused on new drug development and are extremely excited by our recent portfolio expansion. Last month, we entered into a partnership with Precision Biosciences to acquire a worldwide license to Precision's azurecell allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non oncology indications. We believe AzerCell has the potential to be a 1st in class, best in class treatment for certain autoimmune diseases. As an allogeneic off the shelf product, we think EazerCell may offer benefits over autologous CAR T treatments. Overall, we believe AzerCell is a great fit for us, an important addition to our current pipeline.

Speaker 2

AzerCell has been used to treat over 80 cancer patients and we look forward to hopefully treating the first autoimmune patients with AzerCell as soon as possible with an IND filing targeted for mid year. As you can see, we have put together a thoughtful and exciting development plan for 2024 and beyond that we believe can add significant value to our shareholders. We have been and will continue to be measured in our approach to R and D from a capital allocation perspective, including included in our approximately 250,000,000 dollars in projected 2024 operating budget are the dollars required to expand our Brienbi field teams, increase our marketing spend as well as moving forward all of the current development plans we've just discussed. With that, as I bring my prepared remarks to a close, I'd like to say how incredibly proud I am of the team and the progress we've made in 2023. We built a top notch MS focused commercial team that enabled us to rapidly integrate TG and Briumbi into the MS ecosystem.

Speaker 2

And we will continue to build upon this foundation with TG as a trusted partner to the MS community as we strive to serve the patients we treat to the best of our ability. Finally, I also want to congratulate our ex U. S. Partner, NeuraxPharm, on the official launch of Reunbi in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize Reonvi in Europe and the rest of the world.

Speaker 2

With that, me hand the call over to Adam Waldman, our Chief Commercialization Officer to provide a detailed update of the Briombee U. S. Commercial launch. Adam?

Speaker 3

Yes. Thank you, Mike, and good morning, everyone. I'm pleased to share with you the results from the Q4 and cover the highlights from our BRYOMBI commercial launch performance in 2023. Launching Breomby last year was a transformational event for our company. We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward.

Speaker 3

And more importantly, we made a positive difference in the lives of thousands of people living with MS. As reported at the JPMorgan conference last month, 4th quarter net sales for Briambee were $39,900,000 representing 60% growth quarter over quarter and bringing our full year 2023 revenues in at $89,000,000 dollars The 4th quarter number exceeded our guidance and reflects the growing demand we are seeing for BRYANVI. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting BRANVI. We also started seeing increasing prescribing from major academic centers in the 4th quarter as the logistical barriers at these centers continue to decrease. In fact, in the 4th quarter in fact, the 4th quarter was the first time we saw more scripts from academic centers than in the private practice setting, which we view as positive progress given that 60% to 65% of patients are being seen by MS specialists in the academic setting and this has been a focus for our team as we headed into the end of the year.

Speaker 3

Overall in 2023, we saw approximately 3,200 new patient prescriptions come through our hub, which we believe translates into about 3,500 total new patient scripts as not all new prescriptions will come into our hub. We're also pleased to see a wide distribution of use with new prescriptions coming from over 400 centers and 6 40 unique prescribers. Encouragingly, we also saw a diverse mix of patient types, including those that were naive to all treatments and those that were previously treated and switched from both non CD20 and CD20 agents. This mix of patient types remained fairly consistent throughout the year, with the largest group consisting of patients that were previously treated, but naive to anti CD20 therapy. We were also highly encouraged by the persistence of returning patients, which so far appears to be consistent with our assumptions, which was based on what had been seen with the other IV anti CD20 on the market.

Speaker 3

From an execution perspective, our teams did an exceptional job delivering on our launch plan in 2023. We had a well designed and targeted launch strategy efficiently focusing our resources on driving adoption at high volume targeted accounts where we sell the vast majority of our business. At this point, approximately 90% of the top 100 centers in the U. S. Have utilized Breomvieve.

Speaker 3

And with the lowest price of any branded medicine for MS, we prioritize gaining early access and coverage and we're able to achieve coverage for 95% of commercial and Medicare lives within the 1st 9 months of launch. We built the best in class patient support team and our highly experienced and well networked field teams have done an incredible job establishing TG as a respected partner in the MS community. We are very proud of our teams and believe their outstanding efforts are contributing to the positive experience with Briandvi and continue to build confidence in our organization. The cumulative facts of what we've accomplished certainly helped to drive momentum that we saw in 2023 and we expect to see that momentum carry forward this year. Looking forward, we see the CD20 market continuing to grow.

Speaker 3

This class of drugs has transformed the way that MS is treated over the last 5 years with the CD20 share continuing to grow and now capturing approximately 50% to 55% share of new patients every year. And we would expect that that will expand even further going forward. We believe this is a continued tailwind for our business. We also expect that most patients and centers will continue to prefer every 6 month IV dosing schedule, where patients don't have to think about their disease every day or every month and providers have the confidence that their patients are being compliant receiving their medication. We estimate there are approximately 40,000 patients going on a CD20 therapy each year or about 10,000 patients per quarter.

Speaker 3

And in the Q4 of 2023, we had approximately 1,000 prescriptions come into the TG Hub, which would reflect approximately a 10% market share if all these patients were infused. Since not all these patients prescribed Breanvie will actually be infused, these prescriptions through the hub will not translate precisely into market share. But nevertheless, we do believe this is an indicator of strong early demand for Breomv, especially in our 1st year of launch. We also believe we have significant room to grow in what is a large and growing and expanding market. Based on our market research and extensive interaction with neurologists, we continue to believe RAYALDEE's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market.

Speaker 3

This will of course take us time to achieve, but that's very much what we're focused on doing. In 2024, we'll expand our targets and continue to work on educating our customers on the brand B difference. We'll also continue to ramp up our efforts to increase patient awareness, which we believe can be an important driver in this market. So far this year is off to a really strong start where we have seen record enrollments into our hub in January and we believe we are tracking towards the upper end of our Q1 guidance range of $41,000,000 to $46,000,000 and potentially higher if demand trends persist over the next month. We also feel very good about our full year guidance of $220,000,000 to $260,000,000 which we provided at JPMorgan.

Speaker 3

We certainly have work to do, but we are focused and extremely motivated to continue to work every day to bring Briombe to those people 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 Q4 and full year 2023 financial results, which can be viewed on the Investors and Media section of our website. This morning, I'll start with a discussion of our revenue for the Q4 and full year of 2023. As previously mentioned, we are pleased to report U. S.

Speaker 4

Preambi net product revenue of $39,900,000 during the 4th quarter. Also included in our total net product revenue for the Q4 is approximately $3,200,000 of revenue for products sold to NeuroXPharm in support of the ex U. S. Commercial launch and $800,000 of other revenue, taking total revenue for the 4th quarter to approximately $44,000,000 as reported. For the full year, we reported total revenue of approximately $234,000,000 dollars which is predominantly comprised of $88,800,000 in U.

Speaker 4

S. Briohn B net product sales, $140,000,000 in license revenue stemming from the upfront payment for our ex U. S. Commercialization agreement with NeuroXPharm and $3,200,000 in product revenue for products sold to NeuroXPharm, as Felicia mentioned. Our OpEx during the Q4 and full year has remained well controlled and in line with previously discussed ranges.

Speaker 4

For the Q4 and full year 2023, our operating expenses were $56,000,000 213,000,000 dollars respectively, which includes COGS of $7,800,000 $14,100,000 in the respective periods. When excluding on cash compensation, our cash operating expenditures during the Q4 and full year 2023 were approximately $47,000,000 $175,000,000 respectively. On the back of the reported revenues and well controlled OpEx, we were able to report net income of $12,700,000 or $0.09 per diluted share during the full year of 2023. For the Q4 of 2023, we reported a net loss of $14,400,000 or $0.09 per diluted share. And finally, from a cash standpoint, we ended the year with approximately $217,500,000 in cash, cash equivalents and investment securities.

Speaker 4

And we believe our current cash position coupled with our previously guided revenue and expense guidance provides us with sufficient capital to fund our operations to cash flow positivity. With that, I will now turn the call over to the conference operator to begin the Q and A.

Operator

Thank you. The floor is now open for questions. Today's first question is coming from Michael Tuphare of Evercore. Please go ahead.

Speaker 5

Hi. This is Jessica on for Mike. My first question is, in the past, you guys have said that you've heard anecdotal reports of patients not petering out in the days weeks leading up to their subsequent Brian V dose, which is not always the case with competitor anti CD20s. So what's been the feedback on this front and how much do you see Bram B's consistent treatment duration as a key differentiating factor? And then also if I can sneak in another question, what can we expect on gross to net cadence for the balance of the year?

Speaker 5

Thank you.

Speaker 2

Got it. Thanks for question. Adam, you want to field the first one and then I'll have Sean take the second.

Speaker 3

Persistence, I assume you mean the discontinuation rate for patients going from 1st or second infusion to the 3rd infusion. As you know, it's still early, but what I said in my remarks is true so far the trends seem positive and around what we expected based on what we saw with the other IV CD20. So it's right in that range. I don't have any information right now to say that it's better. Certainly don't have any information to say that it's worth, but it's right where we expected.

Speaker 3

And we'll continue to look at it. Certainly, if it's more positive than we think, certainly that will be an accelerator going forward.

Speaker 4

Hi. And on the gross to net front, we have not provided going forward guidance on what to expect. There will be some variability quarter to quarter, but again, we haven't provided precise guidance on what 2024 will look like.

Speaker 5

Great. Thank you.

Speaker 2

Thank you.

Operator

Thank you. The next question is coming from Ed White of H. C. Wainwright. Please go ahead.

Speaker 6

Good morning. Thanks for taking my questions. So, just wondering if you have any numbers on the switches from prior therapies and how that's impacting your sales growth?

Speaker 2

Yes. So I'll start there and Adam can jump in. We haven't provided anything new. I mean, what we've said previously and it still holds true is that, in terms of distribution of patients, we see about, we have 3 buckets. Just to be clear, there's patients that are naive to all treatment.

Speaker 2

There's patients that switch from non CD20 products to CD20. So there's the non CD20 and there's the CD20 switches. What we said is that the largest group coming on to Briompi are those that were naive to CD20, but were pretreated with something else. And then the other 2 buckets, while they're not equal to each other, are relatively similar. And they're reasonably close to the 1st bucket.

Speaker 2

So there's usually there's a nice distribution across all the buckets.

Speaker 6

Okay. Thanks, Mike. And on Europe, congratulations

Speaker 2

on getting the launch in Germany.

Speaker 6

Can you give us your thoughts on the launch in Germany and in other countries and perhaps the cadence of future milestone payments?

Speaker 2

Yes. Adam, you've been a lot closer, you want to take a crack?

Speaker 3

Sure. Hi, Ed. So yes, as you know and as we've spoken about before, getting Brembi launched in Germany was really important. It's the biggest market by far in Europe. So getting that going out of the start was important and we're right on track with that, which is great.

Speaker 3

The other countries will start to come in the later part of this year into next year, including the UK, France, Spain, Italy. And they're continuing to work with the reimbursement authorities and getting through the process they need to on and making sure the drug can be accessed. They're working diligently on that. They have a lot of experience doing it and we'll continue to work through the process. But Germany is by far the largest opportunity and the one that we prioritized first.

Speaker 2

Yes. And then just on the cadence of future milestones, we're not expecting any additional milestones this year. There's a chance we would see a milestone toward the end of next year, an additional milestone. But we'll get more on that later. But I wouldn't expect any additional milestones this year.

Speaker 2

And as we reported JPMorgan, obviously, it's a launch year for these folks and we're not expecting a whole lot of royalty revenues as well.

Speaker 6

Okay. Thanks, Mike. And just lastly, Adam had mentioned adding to the sales force and expanding your reach. How should we be thinking about that as far as the growth over the ramp of SG and A expenses? Are you currently adding?

Speaker 6

Is this something that we should see in the second half of the year? Just any guidance that you can give us on how you're expanding your sales force?

Speaker 2

Yes. So I'll chime in and Adam can and Sean could jump in afterwards. So yes, so as it stands today, even in the Q4, some of that expansion actually most of that expansion is already included, of the current expansion process. So it's already probably built in most of it into the Q4 and there'll probably be a little bit more that trickles into the Q1. And then it's possible over the course of the year there'll be a slow additional build, but most of it's already incorporated and for sure it's incorporated in our OpEx estimate of approximately $250,000,000 for the year.

Speaker 2

So that's all built in to what we're guiding already.

Operator

The next question is coming from Roger Song of Jefferies. Please go ahead.

Speaker 7

Hi. This is Kambe on for Roger. Hi, Mike and team. Good morning. What timeframe do you think is possible to achieve the number one prescribed IVCV20 for Burembi by dynamic share?

Speaker 7

And as a second question, are there any remaining gating factors for you to enter the immuno bioequivalence studies for subcu formulations of Rehambiguity?

Speaker 2

Yes, you broke up a little bit at the end there, but I think I got it. In terms of timeframe to be number 1, we haven't set a timeframe yet, so I can't share one. It's a goal that we have and we're going to keep working towards them. But certainly as we get further along, I don't anticipate 2024 will be the year that we do that. So I think that's pretty sure about that.

Speaker 2

But we are working toward that and we'll keep you posted. In terms of the subcu development, we do have our preliminary subcu formulation that we want to take into the clinic. We don't think that there's anything in our way to do that. We've got some filings to do, but should be pretty straightforward. And we're hoping to have patients on hopefully by midyear.

Speaker 7

Excellent. And then maybe as a couple follow-up questions. Are there is there any preparatory work required to enter BOMB into studies outside of MS? And as a last question, we've noticed there's still a small number of scripts in 3rd party trackers. Some investors are still curious about the trends.

Speaker 7

Maybe we could put this topic to bed for once and all. Do you see any value at all the 3rd party script pack in terms of data?

Speaker 2

Yes, I would certainly love that. Adam, you want to hit that one on the 3rd party? Yes, sure.

Speaker 3

From what I understand, Roger sorry. So what I understand is the data you're seeing is SP data, which is a very small portion of our business, less than 10%. So yes, to put it to bed, I would say it is absolutely not something I would look at.

Speaker 7

Great. Thank you.

Speaker 2

And then your last question about moving outside of MS. There's I don't think there's any pre work that we need to do. I think it's just logistics of getting it done within the context of all the other things that we have on our plate for this year. So that's probably a later in the year event than an earlier year. I think we've got the higher priority projects will be the stuff I talked about where we're trying to make IV pre owned even more convenient, the sub Q and the AzerCell stuff is probably on the higher priority setting for the early part of the year.

Speaker 2

But yes, I don't see any barriers to going outside of MS.

Speaker 7

Thanks, Mike. Appreciate it.

Speaker 2

Yes. You got it. Thank you.

Operator

Thank you. The next question is coming from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Speaker 8

Hey, good morning guys and congrats on the progress.

Speaker 2

Just to stay on the Enhance Phase 3b switching trial, can you provide a little bit more information in terms of what we should be looking for from that data as it's released at, I guess, ACTRIMS and at later conferences this year? Matt, it's like a day or 2 away. Really? You want me to give it all the way? Yes, I mean, look, so what are we trying to accomplish?

Speaker 2

I think it's a fair question. So we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 on to Briamvie. It's no seekers doing an extra 4 hour infusion is not the ideal situation for that patient population who already are B cell depleted. So the goal is step 1 is can you safely take a patient who is on another drug, their B cell depleted and put them on another CD20 without sort of this initial conditioning with a regimen that we have for the starting dose. So that's step 1.

Speaker 2

So safety is the utmost importance and that's what we wanted to do. Partly we wanted to get that done too because we had heard in the field people were just switching people straight through to 1 hour ground beef. So we wanted to make sure we have safety. The next part is, I think we would love to get it into the label. We are eliminating 150 milligrams of drug.

Speaker 2

So there will be an efficacy question. I don't think it's material, sorry, efficacy question, but it has to be answered. So I think as we move forward, 1, what are we looking for, make sure it's safe and well tolerated to switch people directly to a 1 hour preambi from another CD20. And there's any signal that we'd somehow be losing some activity by eliminating the 150 milligrams. So I think we're still probably in the safety phase of this trial.

Speaker 2

So I think in Actrims, we'll be looking for more safety information. Probably by the time we get to Actrims, we should be able to have some additional efficacy. Again, it's single arm. So the efficacy information will be pretty straightforward looking at MRIs and just make in terms of your plans for Briohnve outside of the MS opportunity, in terms

Speaker 8

of your plans for Briampi outside of the MS opportunity, can you help us think about how you prioritize the different indications that you're potentially looking at?

Speaker 2

Yes. I mean, I think, look, we want to get started probably somewhere in the RA Lupus arena with it. I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we look to get AzerCell in some of those indications as well. There's a nice synergy of clinical resources.

Speaker 2

So that's an angle that we're looking at. But I can't promise as the year goes on, we may have additional thoughts and we may start someplace else. But we do believe that BRYANVI is designed well for large market indications and right behind it AZERCELL is designed for the more smaller, sicker kind of patient populations, potentially within the same indications.

Speaker 8

Okay, great. Great. And then lastly,

Speaker 2

in terms of the recent patents that

Speaker 8

you announced, can you provide us some more detail in terms of what they cover and providing the protection outfit was at 2042?

Speaker 2

Yes. I mean, there's a lot of detail on those patents, but I think that some instances that in addition to new composition of matter patent that covers the glycosylation profile of BRYANV plus some use patents within that. We feel good about the 2,040 2 patent protection. So we feel, that we've got a really nice runway here. But the patents are issued.

Speaker 2

They're out there. People can read them. But the overriding concept is that it's composition of matter plus some used patents and 2,142 is a nice new place for our exclusivity to run to.

Operator

Coming from Eric Joseph of JPMorgan. Please go ahead.

Speaker 9

Hi, guys. This is Noah on for Eric. Thanks for taking our question. The question is with regard to subcu Bri on the how important to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalents? Thanks.

Speaker 2

So the current competitor that's moving from their IV to subcu did a bioequivalence study. We're hoping that we'll be able to follow a similar pathway. So I don't think we're going to need to do a full efficacy study to bring the subcu forward, but that will be definitely subject to more conversations with the FDA. But as of now, the competitor subcu that's moving from IV conducted a bioglobulin setting. We think that's an appropriate pathway.

Speaker 2

You got it.

Operator

Thank you. The next question is coming from Prakar Aderwal of Cantor Fitzgerald. Please go ahead.

Speaker 10

Hi, good morning and congrats on the progress and thanks for taking my questions. So number 1, Adam, you said 1Q is tracking at the top end of the guidance range. So maybe if you can give some more details on the January February trends. Where is the demand growth coming from in terms of patient segments as well as physician segments, academic versus community?

Speaker 3

Yes. Hi, Prakhar. Thanks for the question. I'm not going to get into too many details beyond what I said in the prepared remarks. We got off to a really strong start to the quarter.

Speaker 3

And as I said, we're feeling really good about our guidance to the higher end of that range. And then any other details, we'll discuss on the next quarter call.

Speaker 10

Got it. And do you have a sense of what's the split of academic courses, community patient segments for BREOMV and how do you expect that to trend over time?

Speaker 3

Sure. So in the beginning of the year, as I mentioned, it was probably sixty-forty private practice to academics. In the most recent quarters, it's more fifty-fifty academic to private practice and we are seeing, as I mentioned in the remarks, growth coming from academic centers in the latter half of the year and especially in the Q4.

Speaker 10

Got it. And lastly, what percentage of patients who are getting a prescription actually end up getting the infusion? Do you have any additional details on the trend there? And what's the time lag between getting a prescription to getting an infusion right now? And how does it track relative to OCREVUS?

Speaker 3

Yes. So the conversion rate we have it's still pretty early and we have not given a number on that. It's encouraging, but we haven't given a specific number. And perhaps in future calls we'll look at it, but we still think it's very early to be giving that number. And then Prakar, can you repeat the second part of that question?

Speaker 10

Right. So what's the time lag between prescription and getting the infusion? And how does that trend versus OCREUS?

Speaker 3

Yes. So I think what I've said in the past, it's about a 6 week timeframe from enrollment into the hub into the first infusion approximately. And from what we understand and from what we it's very similar to what you see with OCREVUS. There are a lot of things you can control in that process and there's things that are outside your control. We continue to see it trend in the direction and we continue to shorten it over time.

Speaker 3

And so we'd like to see that trend. And we think it's very much in line with what's the competitor product.

Speaker 10

Thank you and congrats on the quarter.

Speaker 2

Thanks.

Operator

Thank you. Our final question today is coming from Mayank Mamtani of B. Riley Securities. Please go ahead.

Speaker 11

Thank you so much. This is actually William Wood on for Mayank Mamtani. Congratulations on the past year and thank you for taking our questions. In terms of the cash and the OpEx burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the subcu trial? And then additionally on the subcu trial, do you have any view of frequency of administration or the kind of device that you will be using for the formulation?

Speaker 11

And then one follow-up. Thank you.

Speaker 2

Yes. So on the subcu, we don't know yet in terms of the frequency of dosing. I think part of that is just going to be let's look at what the conversion is between the 2 from IV to subcu. And from there, we'll be able to design the appropriate dosing interval. Our goal, obviously, we know what the goalposts are.

Speaker 2

We've got once a month from one of the subcu products and the other is once every 6 months with a pretty clunky product as far as we can tell. And so somewhere in between, we think we'd be very successful. So we're going to try to get there. We won't know if we can until we put the material into people and see how it does and see how they react to it.

Speaker 4

And on the OpEx guidance, obviously, we've guided $250,000,000 in OpEx for 2024. We haven't provided a detailed breakdown of how that shakes out. But everything that Mike and the team discussed today is obviously included in that $250,000,000 guidance number.

Speaker 11

Appreciate that. And then just one last question. You obviously you've reported multiple new patents providing protection into 2,142 including Calm, as you just noted, as well as the recent launch in the EU. How should we be thinking about this in terms of potential external parties viewing these events and maybe spurring additional interest in TG?

Speaker 2

Yes. Our goal is to build our business. We're not too worried about external parties. I think if you're referring to external parties, me being investors, I would hope they'd be updating their models to understand the significance of patent protection through 2,040 2 and what that means to the overall NPV of the SAC. Other outside parties I'm not too worried about.

Speaker 11

Appreciate that and thank you for taking our questions.

Speaker 2

Great. Thank you.

Operator

Thank you. At this time, I'd like to turn the floor back over to Mr. Weiss for closing comments.

Speaker 2

Great. And thank you. And again, thanks to everyone for joining us this morning. As reported, we had a great launch year and year 2 while early is taking shape and we're excited about our target guidance for this year of $220,000,000 to $260,000,000 in U. S.

Speaker 2

Net sales revenue. Our pipeline and lifecycle management activities are in full swing and believe these activities could translate into significant future value for TG and our recent patent issuance will ensure a long runway to explore the full potential of Brionvi. Finally, I want to thank again the whole TG team for their dedication to serving the MS community and for their incredible efforts on behalf of TG. Hope everyone has a very nice day.

Operator

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.

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Earnings Conference Call
TG Therapeutics Q4 2023
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