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spk09: Greetings and welcome to the TG Therapeutics fourth quarter and year-end 2023 financial results and business update call. At this time, all participants are on a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you. Please go ahead.
spk00: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and 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&A session. Before we begin, I'd like to remind everyone that we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected 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 filing. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where we'll be available for the next 30 days. Now, I'd like to turn the call over to Mike White, our CEO.
spk04: 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 Brionvi for relapsing forms of multiple sclerosis toward the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million in U.S. Brionvi net revenue for our first partial year of sales. We believe these first-year revenues speak to the high level of early interest and strong underlying demand for Brionvi, and we look forward to continued carry-through in 2024 where we are targeting $220 to $260 million 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 ramp as well as the long-term blockbuster potential of BrionV. Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 from a dynamic market share perspective and the early uptake supports our belief that that is possible. Having said that, this is a competitive market and BrionV is the newest entry, so differentiation matters. One obvious difference is that BrionV is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six 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 one-hour infusion, we are excited to continue to explore biological-based differences that may not be as readily apparent, but are perhaps clinically relevant. As a reminder, BrionV is differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrates that compared to the other anti-CV20s approved or used to treat MS. BrionV has the highest binding affinity to CV20, the target for these types of drugs found on B cells, and through its 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 BrionV have clinical relevance in patients with MS has not yet been determined, as no head-to-head trials have been conducted for BrionV versus the other anti-CD20s. However, what has been well established is that BrionV is the only anti-CD20 monoclonal antibody to achieve an annualized relapse rate of less than 0.1 in Phase III trials. Also, in clinical trials, BrionV 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 BrionV. As we move forward, we are eager to explore to what degree the design attributes of BrionV may be contributing to the robust activity scene. 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 BrionV patent and U.S. biologics exclusivity, the U.S. Patent and Trademark Office recently issued three additional patents for BrionV including a composition of matter patent related to the glycoengineered attributes of BrionV. With these additional patents, our patent protection now extends through 2042, providing us a nice long runway to continue to explore the full potential of BrionV, including expanding the potential reach of BrionV in MS, as well as into other autoimmune diseases, which is a good segue to discuss what is next for BrionV and TG. First, let me say that the U.S. BrionV 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 BrionV lifecycle management activities, as well as new drug development. More specifically, we are focused in four key areas. First, in making IV BrionV even more convenient. Last year, we presented the first data from the enhanced Phase IIIb trial, of which the goal is to evaluate the safety and efficacy of eliminating the 4-hour BrionV 150 mg 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 Actions Conference which is happening later this week. A second key area for us is developing sub-Q pre-OMD. We have completed our preliminary sub-Q formulation and are preparing to enter human bioequivalent studies this year. We believe the sub-Q market could represent a significant new market opportunity for us, as the IV and sub-Q CD20 markets within RMS are rather distinct. Given the known profile of the currently available sub-Q, 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 sub-Q CD20 product. Third, we are looking forward to expanding the realm beyond MS. There are multiple other disease indications where CD20s have proven to have utility. We'll look forward to launching our first autoimmune trial outside of MS this year. And fourth and finally, excuse me, 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 AcerCell Allogeneic CD19 CAR-T Cell Therapy Program for autoimmune diseases and all other non-oncology indications. We believe AcerCell has the potential to be a first in class, best in class treatment for certain autoimmune diseases. As an allogeneic off-the-shelf product, we think Azercel may offer benefits over autologous CAR T treatments. Overall, we believe Azercel is a great fit for us and an important addition to our current pipeline. Azercel has been used to treat over 80 cancer patients, and we look forward to hopefully treating the first autoimmune patients with Azercel as soon as possible with an IMD 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&D from a capital allocation perspective, including in our approximately $250 million in projected 2024 operating budget are the dollars required to expand our pre-MV 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 Brionvi into the MS ecosystem. 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, NurexPharm, on the official launch of BrionV in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize BrionV in Europe and the rest of the world. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update of the BrionV commercial launch.
spk10: Adam? Thank you, Mike, and good morning, everyone. I'm pleased to share with you the results from the fourth quarter and cover the highlights from our BrionV commercial launch performance in 2023. Launching BrionV 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. And more importantly, we made a positive difference in the lives of thousands of people living with MS. As reported at the J.P. Morgan Conference last month, fourth quarter net sales for Brionvi were 39.9 million, representing 60% growth quarter over quarter, and bringing our full year 2023 revenues in at 89 million. The fourth quarter number exceeded our guidance and reflects the growing demand we were seeing for Briamvi. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting Briamvi. We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at these centers continued to decrease. In fact, in the fourth quarter, in fact, the fourth quarter was the first time we saw more scripts from academic centers than in a 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. 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 640 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. 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 BreonV. 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 first nine 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 TGE 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 BrionV and continue to build confidence in our organization. The cumulative effects 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. This class of drugs has transformed the way that MS is treated over the last five 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 an every six 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 And in the fourth quarter 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 BrionV will actually be infused, these prescriptions to the hub will not translate precisely into market share. But nevertheless, we do believe this is an indicator of strong early demand for BrionV, especially in our first 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 Brown-B's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. 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 Brown-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 first quarter guidance range of 41 to 46 million, and potentially higher if demand trends persist over the next month. We also feel very good about our full-year guidance of $220 to $260 million, which we provided at J.P. Morgan. We certainly have work to do, but we are focused and extremely motivated to continue to work every day to bring Breonby to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO.
spk02: Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning, we reported our detailed fourth quarter 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 fourth quarter and full year of 2023. As previously mentioned, we are pleased to report U.S. pre-MV net product revenue of $39.9 million during the fourth quarter. Also included in our total net product revenue for the fourth quarter is approximately 3.2 million of revenue for products sold to NeuroX Farm in support of the XUS commercial launch, and 800,000 of other revenue, taking total revenue for the fourth quarter to approximately 44 million, as reported. For the full year, we reported total revenue of approximately 234 million which is predominantly comprised of $88.8 million in U.S. pre-MV net product sales, $140 million in license revenue stemming from the upfront payment for our ex-U.S. commercialization agreement with NeuroX Farm, and $3.2 million in product revenue for products sold to NeuroX Farm, as previously mentioned. Our OpEx during the fourth quarter and full year has remained well controlled and in line with previously discussed ranges. For the fourth quarter and full year 2023, our operating expenses were 56 million and 213 million, respectively, which includes COGS of 7.8 million and 14.1 million in the respective periods. When excluding on cash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately 47 million and 175 million, respectively. On the back of the reported revenues and well-controlled OPEX, we were able to report net income of $12.7 million, or $0.09 per diluted share, during the full year of 2023. For the fourth quarter of 2023, we reported a net loss of $14.4 million, or $0.09 per diluted share. And finally, from a cash standpoint, we ended the year with approximately $217.5 million in cash, cash equivalents, and investment security. 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&A.
spk09: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star 1 to register a question at this time. Today's first question is coming from Michael DeFore of Evercore. Please go ahead.
spk07: 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 and weeks leading up to their subsequent BrionV 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 BrionV'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 net cadence for the balance of the year? Thank you.
spk03: Got it. Thanks for the question. Adam, you want to field the first one, and then I'll have Sean take the second.
spk10: Persistence, I assume you mean the discontinuation rate for patients going from first or second infusion to the third 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 worse, but it's right where we expected. And, you know, we'll continue to look at it. Certainly if it's more positive than we think, certainly that will be an accelerator going forward.
spk02: 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.
spk09: Great, thank you.
spk06: Thank you.
spk09: Thank you. The next question is coming from Ed White of HC Wainwright. Please go ahead.
spk14: Good morning. Thanks for taking my questions. So I'm just wondering if you have any numbers on the switches from prior therapies and how that's impacting your sales growth.
spk04: Yeah, 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 three buckets. Just to be clear, there's patients that are naive to all treatment. 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've said is that the largest group – coming on to Brionvia are those that were naive to CD20, but were pre-treated with something else. And then the other two buckets, while they're not equal to each other, are relatively similar. And they're reasonably close to the first bucket. So there's a nice distribution across all the buckets.
spk14: Okay. Thanks, Mike. And Europe, congratulations on getting the launch in Germany. Can you give us your thoughts on the launch in Germany and in other countries and perhaps the cadence of future milestone payments?
spk04: Yeah. Adam, you've been a lot closer. You want to take a crack?
spk10: Sure. Hi, Ed. So, yeah, as you know and as we've spoken about before, getting BreMV 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. The other countries will start to come in the later part of this year into next year, including the U.K., France, Spain, Italy. and they're continuing to work with the reimbursement authorities and getting through the process they need to and making sure the drug can be accessed. They're working diligently on that. They have a lot of experience doing it and will continue to work through the process. But Germany is by far the largest opportunity and the one that we prioritized first.
spk04: Yeah, and then just on the cadence of future milestones, it's 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. And as we reported, J.P. Morgan, obviously it's a launch year for these folks, and we're not expecting a whole lot in royalty revenues as well.
spk14: 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 or the ramp of SDNA expenses? Are you currently adding? 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?
spk04: Yeah, so I'll I'll chime in and Adam and Sean can jump in afterwards. So, yeah, so as it stands today, even in the fourth quarter, 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 fourth quarter. There'll probably be a little bit more that trickles into the first quarter. 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 million for the year. So that's all built in to what we're guiding already. You got it, Ed. Thanks.
spk09: Thank you. The next question is coming from Roger Song of Jefferies. Please go ahead.
spk12: Hi. This is for Roger. Hi, Mike and team. Good morning. What time frame do you think it's possible to achieve the number one prescribed IVCV20 for BRAMV by dynamic share? And as a second question, are there any remaining gating factors for you to enter the human bioquivin studies for sub-U formulations of BRAMV?
spk04: Yeah, you broke up a little bit at the end there, but I think I got it. In terms of time frame to be number one, we haven't set a time frame yet, so I can't share one. It's a goal that we have, and we're going to keep working toward it. But certainly as we get further along, I don't anticipate 24 will be the year that we do that. So I think that's pretty sure about that. But we are working toward that, and we'll keep it posted. In terms of the sub-Q development, We do have our preliminary sub-Q 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 it should be pretty straightforward. And we're hoping to have patients on, you know, hopefully by mid-year.
spk12: And then maybe as a couple follow-up questions, is there any preparatory work required to enter B&B into studies outside of MS? And as a last question, we've noticed there's still a small number of scripts in third-party trackers. Some investors are still curious about the trends. Maybe we could put this topic to bed for once and all. Do you see any value at all in the third-party script tracking data?
spk04: Yeah, I would certainly love that. Adam, do you want to hit that one on the third party?
spk10: Yeah, sure. From what I understand, 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.
spk04: Thank you. And then your last question about moving outside of MS. 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 IVs Priyam, even more convenient, the sub-Q and the Acer cell stuff is probably on the higher priority setting for the earlier part of the year. But, yeah, I don't see any barriers to going outside of MS.
spk05: Thanks, Mike. Appreciate it. You got it. Thank you.
spk09: Thank you. The next question is coming from Matt Kaplan of Lattenberg Thelman. Please go ahead.
spk13: Hey, good morning, guys, and congrats on the progress. Just to stay on the enhanced 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 ACTRIMS and at later conferences this year?
spk04: Matt, it's like a day or two away. Really? You want me to give it all away? Yeah, I mean, look, so what are we trying to accomplish? I think it's a fair question. So, you know, we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 onto Priamvi. It's, you know, no secret, doing an extra four-hour infusion is not the ideal situation for that patient population who already are B-cell depleted. So the goal is, step one is, can you safely take a patient who's on another drug, they're V cell depleted, and put them on another CD20 without sort of this initial conditioning regimen that we have for the starting dose. So that's step one. 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 that people were just switching people straight through to one-hour ground vape. So we wanted to make sure we have safety. The next part is, look, you know, I think we would love to get it into the label. You know, we are eliminating 150 milligrams of drug, so there will be an efficacy question. I don't think it's a material efficacy question, but it has to be answered. So I think as we move forward, you know, one, you know, What are we looking for? Make sure it's safe and well-tolerated to switch people directly to a one-hour Priamvi from another CD20. And if 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. So I think in ectrims, we'll be looking for more safety information. Probably by the time we get to ectrims, we should be able to have some additional efficacy. Again, it's, you know, single arm, so the efficacy information will be, you know, pretty straightforward looking at MRIs and just making sure that there's nothing going on that would be surprising.
spk13: Okay. That's really helpful. Thank you. And then in terms of your plans for beyond the outside of the MS opportunity, can you help us think about how you prioritize the different indications that you're potentially looking at?
spk04: Yeah, 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 Azercel and some of those indications as well. There's a nice synergy of clinical resources. So that's an angle that we're looking at. but I can't promise that as the year goes on, we may have additional thoughts and we may start someplace else. But we do believe that BrionV is designed well for large market indications, and right behind it, Azercel is designed for the more smaller, sicker kind of patient populations, potentially within the same indications.
spk13: Okay, great, great. And then lastly, in terms of The recent patents that you announced, can you provide us some more detail in terms of what they cover and provide more protection after it was at 2043?
spk04: Yeah, I mean, there's a lot of detail in those patents, but I think that some substance is that in addition to a new composition of matter patent that covers the like oscillation profile of Brion-V, plus some use patents within that. We feel good about the 2042 patent protection, so we feel that we've got a really nice runway here. But the patents are issued. They're out there. People can read them. But the overriding concept is that it's composition of matter plus some use patents, and 2042 is a nice new place for our exclusivity to run to.
spk13: Perfect. Thanks. Thanks a lot. Yep.
spk05: Thank you.
spk09: Coming from Eric Joseph of JPMorgan, please go ahead.
spk11: Hi, guys. This is Noah on for Eric. Thanks for taking our question. Our question is with regard to subcube beyond the – how important – to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence?
spk04: Thanks. So the current competitor that's moving from their IV to sub-Q 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 sub-Q forward, but that will be definitely subject to more conversations with the FDA. But as of now, the competitor sub-Q that's moving from IV conducted a bioequivalent setting. We think that's an appropriate pathway.
spk02: Thank you. You got it.
spk09: Thank you. The next question is coming from Prakhar Otterwal of Cantor Fitzgerald. Please go ahead.
spk01: Hi, good morning and congrats on the progress and thanks for taking my question. So number one, Adam, you said OneQ is tracking at the top end of the guidance range. So maybe if you can give some more details on the January and February trends, where is the demand growth coming from in terms of patient segments as well as physician segments, academic courses, community?
spk10: Hi, Prakash. 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. And as I said, you know, we're feeling really good about our guidance to the higher end of that range. And then, you know, any other details we'll discuss on the next quarter call.
spk01: Got it. And Do you have a sense of what's the split of academic courses, community patient segments for BMV, and how do you expect that to trend over time?
spk10: Sure. So in the beginning of the year, as I mentioned, it was probably 60-40 private practice to academics. In the most recent quarters, it's more 50-50 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 fourth quarter.
spk01: 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?
spk10: Yeah, so the conversion rate we have It's still pretty early, and we have not given a number on that. It's, you know, 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, Prakhar, can you repeat the second part of that question?
spk01: Right. So what's the time lag between prescription and prescription? getting the infusion, and how does that trend versus Ocrevus?
spk10: Yeah. So I think what I've said in the past, it's about a six-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 – we continue to shorten it over time, and so we'd like to see that trend, and we think it's very much in line with what's the competitor product.
spk01: Thank you, and go right to the quarter. Thanks.
spk09: Thank you. Our final question today is coming from Mayank Mamtani of B. Reilly Securities. Please go ahead.
spk08: Thank you so much. This is actually William Wood. I'm from Montana. 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 sub-Q trial and then additionally on the sub-Q trial? Do you have any view of frequency of administration or the kind of device that you'll be using for the formulation? And then one follow-up. Thank you.
spk04: Yeah. So, on the sub-Q, you know, 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 two from IV to sub-Q. And from there, we'll be able to design the appropriate dosing interval. Our goal, obviously, we know what the goalposts are. We've got once a month from one of the sub-Q products, and the other is once every six 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.
spk02: And on the OPEX guidance, obviously we've guided 250 in OPEX for 24. 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 guidance number.
spk08: Appreciate that. And then just one last question. Obviously, you've reported multiple new patents, providing protection into 2042, including COM, 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 TGV?
spk04: Yeah, our goal is to build our business. We're not too worried about external parties. I think if you're referring to external parties being investors, I would hope they'd be updating their models to understand the significance of patent protection through 2042 and what that means to the overall NPV of the SAP. Other outside parties, I'm not too worried about.
spk08: Appreciate that, and thank you for taking our questions.
spk03: Great, thank you.
spk09: Thank you. At this time, I'd like to turn the floor back over to Mr. Weiss for closing comments.
spk04: Great, and thank you. And again, thanks to everyone for joining us this morning. As reported, we had a great launch year, and year two, while early, is taking shape, and we're excited about our target guidance for this year of $220 to $260 million in U.S. 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 BrionV. 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.
spk09: 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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