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Earnings call: TG Therapeutics reports robust BRIUMVI sales in 2023

EditorNatashya Angelica
Published 2024-03-01, 04:48 p/m
Updated 2024-03-01, 04:48 p/m
© Reuters.

TG Therapeutics, Inc. (NASDAQ:TGTX) experienced a successful 2023, marked by the launch of BRIUMVI, a new treatment for relapsing forms of multiple sclerosis (MS). In its first partial year, BRIUMVI generated approximately $90 million in U.S. net revenue. The company anticipates U.S. sales revenue to reach between $220 million and $260 million in 2024.

With a focus on becoming the leading CD20 therapy by market share, TG Therapeutics is exploring further applications of BRIUMVI in other autoimmune diseases and developing a subcutaneous formulation. The company has also secured a worldwide license for a CD19 CAR T cell therapy program for autoimmune diseases.

The earnings call highlighted the strong demand for BRIUMVI, its successful launch in Germany, and plans for expansion in other European countries.

Key Takeaways

  • TG Therapeutics launched BRIUMVI in January 2023, targeting relapsing MS, with $90 million in U.S. net revenue for the year.
  • The company aims for $220 million to $260 million in U.S. sales revenue in 2024.
  • BRIUMVI is positioned to be the IV therapy of choice in the relapsing MS market, with efforts to expand its use into other autoimmune diseases.
  • The company is developing a subcutaneous version of BRIUMVI and has a CD19 CAR T cell therapy program in the works.
  • TG Therapeutics ended the year with $217.5 million in cash, cash equivalents, and investment securities.
  • The company reported strong demand with 640 unique prescribers and over 400 centers distributing BRIUMVI.
  • No additional milestones are expected this year, but there may be one by the end of next year.
  • New patents have been secured, providing protection until 2042.

Company Outlook

  • TG Therapeutics is on track to meet the higher end of their first-quarter guidance range.
  • The company's OpEx guidance for 2024 is $250 million, which includes all discussed activities.
  • Expansion into European markets is progressing, with launches in the UK, France, Spain, and Italy anticipated later this year and into the next.

Bearish Highlights

  • No specific details were provided regarding sales trends.
  • The timeframe to achieve the goal of becoming the number one prescribed IV CD20 has not been set.
  • Uncertainty remains about the dosing frequency for the subcutaneous BRIUMVI formulation.

Bullish Highlights

  • BRIUMVI's launch strategy has led to coverage for 95% of commercial and Medicare lives within nine months.
  • The CD20 market is expected to capture 50% to 55% share of new MS patients annually.
  • There is growing demand from both academic and private practice segments.

Misses

  • The company did not provide specific details on patient conversion rates or the time lag between prescription and infusion.
  • The allocation of spend between trials and the subcutaneous trial is yet to be determined.

Q&A Highlights

  • The company discussed the potential of not needing a full efficacy study for the IV to subcutaneous transition, pending FDA discussions.
  • A competitor's bioequivalence study for their subcutaneous product was mentioned as a reference point.
  • TG Therapeutics is evaluating the conversion rate from prescription to infusion and is working to shorten this time lag.

InvestingPro Insights

TG Therapeutics, Inc. (TGTX) has shown remarkable performance in the market, with analysts forecasting an upward trajectory in sales growth for the current year. This optimism is likely tied to the company's successful launch of BRIUMVI and its anticipated expansion in the U.S. and European markets.

In line with these projections, the company's revenue growth has been extraordinary in the last twelve months as of Q4 2023, with an increase of over 8290%.

InvestingPro Data indicates a substantial gross profit margin of 93.95% in the same period, underscoring the company's efficiency in managing its cost of goods sold relative to its sales. This high margin is a testament to TG Therapeutics' strong pricing power and operational effectiveness, which is crucial as it scales up its operations.

The company's stock has also experienced significant returns, with a 29.28% increase over the last week, reflecting investor confidence in the company's strategy and market position. However, it's important to note that TGTX is trading at a high Price / Book multiple of 15.78, which suggests that the market has high expectations for the company's future growth and may also reflect a premium for its innovative therapies and market potential.

For investors seeking a more in-depth analysis, there are additional InvestingPro Tips available for TGTX, including insights on earnings revisions, valuation multiples, and stock price volatility. By using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to these valuable tips and data points. There are 16 more InvestingPro Tips listed on InvestingPro for TGTX, which can provide further guidance for those interested in the company's financial health and market prospects.

Full transcript - TG Therapeutics Inc (TGTX) Q4 2023:

Operator: 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. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco. Thank you. Please go ahead.

Jenna Bosco: 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 statement. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

Michael Weiss: Thanks, Jenna, 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 BRIUMVI 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. BRIUMVI 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 BRIUMVI, and we look forward to continued carry-through in 2024, where we are targeting $220 million 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 BRIUMVI. Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 by dynamic market share perspective, and the early uptake supports our belief that that is possible. Having said that, this is a competitive market and BRIUMVI is the newest entry, so differentiation matters. One obvious difference is that BRIUMVI 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, BRIUMVI 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-CD20s approved or used to treat MS, BRIUMVI has the highest binding affinity to CD20. 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 BRIUMVI have clinical relevance in patients with MS has not yet been determined, as no head-to-head trials have been conducted for BRIUMVI versus the other anti-CD20s. However, what has been well established is that BRIUMVI 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, BRIUMVI 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 BRIUMVI. As we move forward, we are eager to explore to what degree the design attributes of BRIUMVI 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 BRIUMVI patent and U.S. Biologics exclusivity, the U.S. Patent and Trademark Office recently issued three additional patents for BRIUMVI, including a composition of matter, patent related to the glycoengineered attributes of BRIUMVI. 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 BRIUMVI, including expanding the potential reach of BRIUMVI in MS, as well as into other autoimmune diseases, which is a good segue to discuss what is next for BRIUMVI and TG. First, let me say that the U.S. BRIUMVI 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 BRIUMVI lifecycle management activities, as well as new drug development. More specifically, we are focused in four key areas. First, in making IV BRIUMVI even more convenient. Last year, we presented the first data from the enhanced Phase 3b trial, of which the goal is to evaluate the safety and efficacy of eliminating the four-hour BRIUMVI 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 ECTRIMS Conference, which is happening later this week. A second key area for us is developing subcu BRIUMVI. We have completed our preliminary subcu formulation and are preparing to enter human bioequivalent studies this year. 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. Third, we are looking forward to expanding BRIUMVI 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. And fourth 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 (NASDAQ:DTIL) to acquire a worldwide license to Precisions azer-cel, allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. We believe azer-cel 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 azer-cel may offer benefits over autologous CAR T treatments. Overall, we believe azer-cel is a great fit for us and an important addition to our current pipeline. Azer-cel has been used to treat over 80 cancer patients and we look forward to hopefully treating the first autoimmune patients with azer-cel 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&D from a capital allocation perspective, included in our approximately $250 million and projected 2024 operating budget of the dollars required to expand our BRIUMVI 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 BRIUMVI into the MS ecosystem. 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 BRIUMVI in Europe, which took place this week in Germany. We look forward to hearing more about their progress as they endeavor to commercialize BRIUMVI 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 BRIUMVI US commercial launch. Adam?

Adam Waldman: 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 BRIUMVI commercial launch performance in 2023. Launching BRIUMVI 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 JP Morgan (NYSE:JPM) Conference last month, fourth quarter net sales for BRIUMVI 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 are seeing for BRIUMVI. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting BRIUMVI. We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at these centers continue to decrease. 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 team’s 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 saw the vast majority of our business. At this point, approximately 90% of the top 100 centers in the U.S. have utilized BRIUMVI. And with the lowest price of any branded medicine for MS, we prioritized gaining early access and coverage, and were able to achieve coverage for 95% of commercial and Medicare lives within the first nine months of launch. We built a 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 BRIUMVI 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 BRIUMVI will actually be infused, these prescriptions through the Hub will not translate precisely in to market share. But nevertheless, we do believe this is an indicator of strong early demand for BRIUMVI, 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 BRIUMVI'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 BRIUMVI 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 million 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 million to $260 million, which we provided at JP Morgan. We certainly have work to do, but we are focused and extremely motivated to continue to work every day to bring BRIUMVI to those people living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO.

Sean Power: 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. BRIUMVI 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 Neuraxpharm in support of the ex-U.S. 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. BRIUMVI net product sales, $140 million in license revenue stemming from the upfront payment for our ex-U.S. commercialization agreement with Neuraxpharm, and $3.2 million in product revenue for products sold to Neuraxpharm, 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.

Operator: Thank you. The floor is now open for questions. [Operator Instructions]. Today's first question is coming from Michael DiFiore of Evercore. Please go ahead.

Unidentified Analyst: 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 BRIUMVI 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 BRIUMVI's consistent treatment duration as a key differentiating factor? And then also, if I can sneak in another question, what can we expect on growth-to-net cadence for the balance of the year? Thank you.

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

Adam Waldman: Persistence, I assume you mean the discontinuation rate for patients going from first or second infusion to third infusion. As you know, it's still early, but what I said in my remarks is true so far that 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. I certainly don't have any information to say that it's worse, but its right where we expected 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.

Sean Power: Hi. And on the growth-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.

Unidentified Analyst: Great. Thank you.

Michael Weiss: Thank you.

Operator: Thank you. The next question is coming from Ed White with H.C. Wainright. Please go ahead.

Edward White: 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.

Michael Weiss: 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 BRIUMVI are those that were naive to CD20, but were pretreated with something else. And then the other two buckets, while they are not equal to each other, are relatively similar and they are reasonably close to the first bucket. So there's usually – there's a nice distribution across all the buckets.

Edward White: Okay. Thanks Mike. And on 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?

Michael Weiss: Yeah. Adam, you've been a lot closer. You want to take a crack?

Adam Waldman: Sure. Hi Ed. So yeah, as you know and as we've spoken about before, getting BRIUMVI 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 are 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 UK, France, Spain, Italy, and they are continuing to work with the reimbursement authorities and getting through the process they need to in making sure the drug can be accessed. They are 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.

Michael Weiss: Yeah. And then just on the cadence of future milestones, we are 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. As we reported to Morgan, obviously it's a launch year for these folks and we're not expecting a whole lot in royalty revenues as well.

Edward White: 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 SG&A expenses? Are you currently adding? Is this something that we should see in the second half of the year or just any guidance that you can give us on how you are expanding your sales force?

Michael Weiss: Yeah. So I'll chime in and Adam and Sean could jump in afterwards. 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 and 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 its 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 are guiding already.

Edward White: Okay. Thanks Mike.

Michael Weiss: You got it, Ed. Thanks.

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

Unidentified Analyst: Hi. This is Con Bizon [ph] for Roger. Hi, Mike and team. Good morning. What timeframe do you think it's possible to achieve the number one prescribed IV CD20 for BRIUMVI by dynamic share? And as a second question, are there any remaining gating factors for you to enter the human bioequivalence studies for subcu formulations of BRIUMVI there?

Michael Weiss: Yeah, you broke up a little bit at the end there, but I think I got it. In terms of timeframe to be number one, 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 toward it. But certainly as we get further along, I mean, 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 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 it should be pretty straightforward, and we're hoping to have patients on, hopefully by mid-year.

Unidentified Analyst: Excellent. And then maybe as a couple of follow-up questions, is there any preparatory work required to enter BRIUMVI 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 a third-party script tracker going to data?

Michael Weiss: Yeah, I would certainly love that. Adam, you want to hit that one on the third party?

Adam Waldman: Yeah sure. From what I understand, Roger – or it wasn't Roger, but – sorry. So what I understand is, the data you are 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.

Unidentified Analyst: Great. Thank you.

Michael Weiss: 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 are trying to make IV BRIUMVI even more convenient. The subcu and the azer-cel stuff is probably on a higher priority setting for the earlier part of the year. But yeah, I don't see any barriers to going outside of MS.

Unidentified Analyst: Thanks Mike. I appreciate it.

Michael Weiss: You got it. Thank you.

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

Matt Kaplan: Hey, good morning, guys, and congrats on the progress. Just to stay on the enhanced – yeah, good morning. 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, I guess, ACTRIMS and at later conferences this year?

Michael Weiss: 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, we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 on to BRIUMVI. It's no secrets. 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 are 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 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 BRIUMVI. So we wanted to make sure we have safety. The next part is, look, I think we would love to get it into the label. 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, one, what are we looking for? Make sure it's safe and well-tolerated to switch people directly to a one-hour BRIUMVI 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 ACTRIMS 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 its single arm, so the efficacy information will be, pretty straightforward, looking at MRIs and just making sure that there's nothing going on that would be surprising.

Matt Kaplan: Okay. That's really helpful. Thank you. And then in terms of your plans for BRIUMVI outside of the MS opportunity, can you help us think about how you prioritize the different indications that you are potentially looking at?

Michael Weiss: 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 azer-cel 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 as the year goes on. We may have additional thoughts and we may start someplace else. But we do believe that BRIUMVI is designed well for large market indications and right behind it, azer-cel is designed for the more smaller, sicker kind of patient populations, potentially within the same indications.

Matt Kaplan: Okay. 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 providing the protection after it was at 2042?

Michael Weiss: Yeah. I mean, there's a lot of detail in those patents, but I think the sum in some sense is that in addition to a new composition of matter patent that covers the glycosylation profile of BRIUMVI 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 forms are issued, they are out there. People can read them. But the overriding concept is that it's a composition of matter plus some use patents. 2042 is a nice new place for our exclusivity to run to.

Matt Kaplan: Okay. Thanks a lot.

Operator: We have a question coming from Eric Joseph of JP Morgan. Please go ahead.

Unidentified Analyst: Hi, guys. This is Noah. I'm for Eric. Thanks for taking our question. Our question is with regard to subcu BRIUMVI? How important to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence? Thanks.

Michael Weiss: 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 bioequivalence study and we think that's an appropriate pathway.

Unidentified Analyst: Thank you.

Michael Weiss: You got it.

Operator: Thank you. The next question is coming from Prakhar Agrawal with Cantor Fitzgerald. Please go ahead.

Prakhar Agrawal: Hi. Good morning and congrats on the progress. And thanks for taking my question. So number one, 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 and February trends. Where is the demand growth coming from in terms of patient segments, as well as physician segments, academic versus community?

Adam Waldman: Yeah. 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. 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.

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

Adam Waldman: 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.

Prakhar Agrawal: 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?

Adam Waldman: Yeah. 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. 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?

Prakhar Agrawal: Right. So what's the time lag between a prescription and getting the infusion, and how does that trend versus Ocrevus?

Adam Waldman: 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 a 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.

Prakhar Agrawal: Thank you. And Congrats on the quarter.

Michael Weiss: Thanks.

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

William Wood: 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'll be using for the formulation? And then one follow-up. Thank you.

Michael Weiss: Yeah, 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 two 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. We've got once a month from one of the subcu 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.

Sean Power: Alright. And on the OpEx guidance, obviously we've guided $250 million in OpEx for ‘24. We haven't provided a detailed breakdown of how that shapes out, but everything that Mike and the team discussed today is obviously included in that $250 million guidance number.

William Wood: Appreciate that. And then just one last question. You obviously reported multiple new patents providing protection in the 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 TG?

Michael Weiss: Yeah, our goal is to build our business. We're not too worried about external parties. I think if you are 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.

William Wood: I appreciate that, and thank you for taking our questions.

Michael Weiss: Great. Thank you.

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

Michael Weiss: 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 million 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 BRIUMVI. 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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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