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spk02: Greetings and welcome to the TG Therapeutics third quarter earnings conference call. At this time, all participants are in 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, Jenna. You may begin.
spk00: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third quarter 2022 financial results and provide a business update 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 provide an update on our commercialization efforts, and Sean will provide a brief 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, clinical development plans, and expectations for our marketed and pipeline 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 subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This call is being recorded for audio rebroadcast on TG's website at 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.
spk08: Thanks, Jenna, and good morning, everyone, and thanks for joining us on the call. The third quarter of 2022 was a very productive time for TG, as the team really came together to execute on our pre-launch commercialization plans. As we've mentioned previously, our goals for this year are to work toward an FDA approval for Lutuximab in relapsing forms of multiple sclerosis and to be prepared, if approved, to launch early next year. We've guided that our goal was to dedicate the resources necessary to achieve these goals and minimize or eliminate all other expenses. I'm pleased to report that our streamlining and focusing efforts have been extremely successful in reducing our overall burn while reserving our resources to support the potential approval and launch of Lubatuximab. Sean Power, our CFO, will join us shortly and provide some additional details, but our burn for the third quarter was approximately $34 million, down substantially from prior quarters. I'm proud of the hard work and team effort that was required to realize these cost savings, while ensuring we were all well-positioned financially for the potential launch of Lubatuximab. Also, in just a few minutes, Adam Waldman, our Chief Commercialization Officer, will join us to provide more details around our launch planning and progress, which from my vantage point seems to be moving along quite nicely. We believe that if approved, Ubutuximab has the potential to play a meaningful role in the treatment of multiple sclerosis and we remain committed to offering patients a highly active treatment option with the convenience of a one-hour fusion administered every six months following the first dose. With that, let me remind everyone of our phase three program that is supporting our BLA submission for Ublatuximab in relapsing forms of MS, also referred to as RMS. The ultimate one in two phase three trials evaluated Ublatuximab compared to teraflutamide enrolling approximately 1,100 patients across 10 countries and were led by Dr. Laurence Steinman of Stanford University. As noted in the past, both studies met their primary endpoint with Ubutuximab treatment demonstrating a statistically significant reduction in annualized relapse rate. It's also referred to as ARR compared to teraflutamide. In addition to the positive primary endpoint results, we've had the opportunity over the past year to present several different sub-analysis of this data set, which we believe continues to show an encouraging profile for Ubutuximab for the treatment of patients with RMS. Most recently, we had the opportunity to present five additional exploratory data sets at the 2022 Annual Congress of the European Committee for the Treatment and Research in Multiple Sclerosis, commonly referred to as ECTRIMS. The team engaged with numerous KOLs during this meeting, and the feedback we received around the profile of lubotuximab was highly encouraging, and we believe the data presented further support the potential for lubotuximab to treat patients with RMS, if approved. Now, on the regulatory front, as in the past, we will not provide color on any interactions with the FDA, but we would like to provide an update on where we are in the process. With less than two months for the target PDUFA action date of December 28, 2022, we can confirm that we have completed the late cycle meeting and labeling discussions have recently commenced. We remain hopeful that Lubletuximab will be approved, and if approved, we'll be excited to make Ubisatzimab available to the many patients with RMS that are in need of additional treatment options. I will also mention that our efforts with the EMA for EU approval are moving along, and from a timing perspective, potential approval could occur in the second half of 23. We are still assessing the go-to-market strategy in Europe, and we continue to evaluate whether to go it alone or whether to partner with XUS. So with that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, to share some thoughts on our preparations over the past quarter, as well as his thoughts on the potential commercial opportunity and plans for Ubitoximab and RMS. Adam?
spk07: Thank you, Mike, and good morning, everyone. I'm excited to provide an update on our commercial activities, as we have made considerable progress over the last several months on our preparations for the anticipated Ubitoximab launch in relapsing forms of multiple sclerosis. MS is a debilitating chronic disease that can have a significant impact on the quality of life of patients and their families. The CD20 class has truly transformed the way MS is treated, and physicians believe that using these agents early may significantly impact the natural course of the disease. Today, approximately one of every two patients starting a new therapy will go on a CD20. In fact, market data shows that in the second quarter of 2022, there was the highest share of CD20 usage we have seen since these agents were launched. This is a large and growing market, and based on our market research, we believe Lubaltoxamab has the potential to capture meaningful market share. We understood from the moment we started working in this space that one of the keys to success would be to hire a team of MS-experienced professionals with a deep knowledge of the landscape and strong relationships across the MS community. To that end, we have been methodical in how we have hired our commercial field teams and have hand-selected people that fit our target profile. Over the last several months, we have significantly ramped up our hiring, adding critical field-based customer-facing roles in sales, sales leadership, and access and reimbursement support. Our hires, on average, have 12-plus years of MS industry experience. They joined our previously hired field-based regional marketing team, as well as our payer and medical teams, which have been engaging providers and payers for the last 12 months. At this point, we have met our internal hiring goals for our field-based team members, and we will be working over the next several weeks to finalize the hiring and training of these teams to be prepared for launch. Our team also knows how important it is to get this drug to the patient community, and is working hard to ensure we do everything we can to provide access to letuximab once approved. One of the biggest frustrations we hear from physicians and practices in general is navigating the process of access and reimbursement for therapies. We have therefore placed a significant emphasis on ensuring that the process to access to letuximab will be as seamless as possible. I'm extremely proud of the progress our team has made over the last several months building our capabilities in this area. First, from a payer perspective, our national account teams have been doing a great job engaging with national regional payers for over the last year. Feedback on the clinical profile of bupaximeb has been positive, and we do not foresee any major issues with reimbursement. However, with any new product, payers will need to work through their processes over the first 90 to 180 days post-launch. Second, we have made considerable progress understanding the institutional formulary process and have plans in place to work with the key MS centers of excellence to include glutuximab on their formularies as soon as possible. Third, we know the majority of MS patients will opt into patient support programs, and that this is another critical component of ensuring access. We have worked very closely with key customers to build what we believe will be a best-in-class patient support program, and we are on track to be ready to launch this program alongside Ublituximab once approved. Lastly, we have now hired an experienced field-based access and reimbursement team that will work with accounts to facilitate access to Ublituximab. In summary, we have made tremendous progress on building and strengthening our commercial capabilities over the last 12 months, which has accelerated over the last few months as we ready the organization for the possibility of an uvepleximab launch. We have built an incredible team, which we believe is as experienced, if not more so, on a pound-for-pound basis than any MS team in the industry. These teams are ramping up their activities, actively engaging key participants in the MS community, KOLs, community neurologists, payers, and advocacy groups at conferences, advisory boards, and other engagements. Our confidence continues to grow as the feedback on Ubutuximab's profile and the way we have built our commercial team has been very positive across the board. We believe this launch represents a significant commercial opportunity, and all of our attention, focus, and commercial resources are aimed at making this a success. We continue to move forward with a sense of urgency and purpose, as we know Ubutuximab, if approved, will be an important new option for patients managing this debilitating disease. And with that, I'm going to hand it over to Sean.
spk05: Thank you, Adam. And thanks, everyone, for joining us this morning. Earlier, we reported our detailed third quarter 2022 financial results, which can be viewed on the investors and media section of our corporate website. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash positions. We ended the third quarter with approximately $198 million in cash, cash equivalents, and investment securities. That, coupled with the additional capacity available under our Hercules facility upon Ubituximab approval, we believe will be sufficient to take us into 2024. We are pleased to report that our burn for the third quarter of 2022 came in under our previously guided range of $45 to $50 million. landing in approximately $34 million for the quarter, also well below prior quarters, which, as Mike said, is the result of our determined cost savings measured and our focused preparations for the upcoming launch of Uba Tutsumab, along with some timing differences, which we will incur in future quarters. Our gap net loss for the third quarter of 2022 was approximately $36 million, or $0.26 per share. which was a decrease of almost 50 million from Q3 of 21, where we saw a net loss of approximately 86 million, or 65 cents per share. As compared to the prior year quarter, the decrease was driven by across-the-board decreases in R&D and SG&A, primarily due to a streamlining of our oncology operations and a shift in focus to our MS development and launch preparation efforts. The GAAP net loss for the nine months ended September 30th, 2022 was $145.3 million, or $1.08 per share, compared to a net loss of $254.8 million, or $1.93 per share, for the comparable quarter in 2021, representing a decrease in net loss of more than $100 million, period over period. In terms of what we expect moving forward, We project our burn for the fourth quarter of 2022 to be between $40 and $50 million, which we believe leaves us well positioned through the anticipated MS PDUFA at the end of the year. With that, I'll now turn the call back over to the conference operator to begin the Q&A.
spk02: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. 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 your handset before pressing the star key. One moment, please, while we poll for questions. Thank you. Our first question is from Ed White with HC Wainwright. Please proceed with your question.
spk06: Good morning. Thanks for taking my questions. So just on the, you had mentioned the EMA timing is the second half of 23. How do you describe, can you describe the opportunity in Europe? What is the market like? What are your expectations for it? And then as far as partnering, If you're going to partner, when should we expect to hear something like that? Would that be prior to approval, do you think, or that would be something that would come after approval?
spk08: Hey, Ed, thanks for the question. So, you know, the EU opportunity is interesting. I think the EU currently probably represents about 20-ish percent of the overall market opportunity for CD20s. So that's So it's a reasonable size piece of the market, but it's not obviously a large portion, so it's not high focus for us. Most of that, in terms of dollars, is in Germany. The other countries, obviously, they're in there, but it's a lot less. So as we think about the opportunity and we think about potentially setting up an organization in Europe, I think it probably would be Germany-focused and then we'd spread out from there if we did it on our own. In terms of timing of a partnership, we're not providing any timing, but it could happen before, after we launch there. It's always very speculative. But I would say, again, if our ultimate decision is to partner to launch, then invariably it would happen in advance.
spk06: Okay, thanks, Mike. And you've done an incredible job on cost cutting. I'm just thinking about how should we consider R&D expenses going forward? You gave some guidance on HDNA being up in the quarter. You know, what are the R&D opportunities? How should we be thinking about that? And how should we be thinking of the expense for that line?
spk08: Yeah, I would expect that the R&D expenses will continue to go down. Again, we still have oncology trials that are just, you know, far too completely shut down. So we're carrying some of those expenses still. But as they continue to go down, we'll probably, not probably, we will be starting additional studies around uvatoximab and MS and potentially outside of that. But... So I think it continues to go down for the next quarter or two, but maybe Sean wants to chime in, and then it probably starts to creep back up in the second half of next year. Sean, is that about right, or any other color? Yeah, no, I think that's fair, Mike.
spk06: Okay, great. Thanks for taking my questions. Thanks, Ed.
spk02: Thank you. Our next question is from Chris Howerton with Jefferies. Please proceed with your question.
spk11: Great. Thank you so much. I just wanted to ask a couple questions on kind of the expected commercial dynamics. You know, ofatumumab has been doing a little bit better in the launch, so I was curious how you were thinking about the differences between dosage forms in the CD20s and maybe if there would be some differential patient or physician targeting. between those two, so that would be one question. And then the second question I have is just a kind of housekeeping thing as I was looking at our model. What is the latest kind of IP expiry that you're expecting, Mike and Tim? Thank you so much.
spk08: Sure. So on the IP side, I think the patents for Latuximab, the basic patents are with patent term expansion 20, 32, 33. assuming there is an approval, we'll be entitled to 12 years market exclusivity for biologics. That would actually put us into 25 or very, very late 24. Sorry, 34, late 34 or early 35 to the 12 years. Sorry about that. And then we do have some other patents we haven't spent much time talking about that could go on for another five, ten plus years. So we think we've got a pretty good runway with the patents, with the biological exclusivity, and potentially with some other patents behind the scenes. I will briefly answer your first question, and then I'll let Adam discuss it. But, you know, it's interesting in terms of the dosage forms. It's really become somewhat two markets. I think the physicians, the prescribers view these products somewhat differently and in different settings in which they might want to use them. Most doctors and most patients, actually we heard yesterday in one-on-one engagements, that even most patients are just not interested in dealing with their disease once a month. But it does seem that the sub-Q has a nice role for patients who travel distances to get to their MS provider. And so we had projected early on that that sub-Q would probably represent about 30% of the market. And it does feel like that's where they're capping out. Obviously, their overall market share continues to grow because, as you know, there's an accumulation effect. As people come on, they stay on. But their dynamic share is getting close to capped, and I think it's between 25% and 30% of the dynamic share. And that's kind of where we see the market. So I think that's about how we believe it's going to continue to shake out. About 70% of the patients will continue to receive an IV, 80-20, and about 30% will go with the sub-Q. Adam, please add some more color.
spk07: I think you pretty much covered it, Mike. The only thing I would add is that it does seem like the market, with Casimta's launch, it does seem like the market has continued to expand significantly. perhaps outside the centers of excellence and more rural areas and perhaps more general neurologists. But what Mike said is pretty much exactly what I would have said.
spk11: Okay. And maybe just as a minor kind of follow-up, if you'll entertain it, Adam, and then Mike, too, of course. Would you, I guess, how are you thinking about targeting those physicians that would be more likely to prescribe IV versus sub-Q, I guess?
spk10: Do you have that disability, do you think?
spk07: Yeah, I mean, you know, yeah, I'll start by looking at, you know, I think MS centers of excellence that have infusion capabilities, I think community practices that have infusion capabilities, would be a logical place to start and make sense in terms of where we think IV usage will predominantly continue to be. And so that is where we believe the initial focus for us should be. And I think the majority of Ocrevus use is seen in those large MS centers of excellence and these very large community centers with infusion capabilities.
spk08: Yeah, thanks. I'll add to that, Chris, that, you know, when we think about, you know, the best or highest ROI for us, obviously it's going after the sites that Adam has referred to. The general neurologist is just, I think, getting into CD20s, and that's, I think, a huge effort of both the Roche, Dentac, and Novartis teams. to get out there. I do think, again, as Adam mentioned, as they're pushing into the more rural environments, I think those are going to be nice areas for something like Cosimta, where they may be far from their physician. And general neurologists, again, who don't have infusion capabilities might be an interesting place for something like Cosimta. But for us, the vast majority of the business, and the vast majority of the current OkraVis business, I think close to 80%, is still concentrated in those large centers of excellence in large community practices.
spk10: Okay. That sounds excellent and a more efficient business model, it sounds like, too. So thanks, guys. Yep. Thanks, Chris.
spk02: Thank you. Our next question is from Matt Kaplan with Leidenberg-Fallman. Please proceed with your question.
spk09: Hi. Thanks for taking the questions and congrats on the progress, guys. Thanks, Matt. I just wanted to... take Chris's question a little bit more forward. Can you comment on, I guess, Roche's subcutaneous programs and their high-dose program as well, and how do you think those will impact the market other than what you said?
spk08: Yeah, so I'll go first, Adam. You can chime in. You know, we don't know a ton about those programs. I mean, we know certain timing. Essentially, I think the sub-two could be available in the next two years, give or take. And then on the high dose, we don't really have any good visibility into where they are with that other than to say that I think their high dose strategy is to try to comp off of our potentially perceived better activity with a more potent CD20. We'll see how that works out for them, but again, I think it's going to take them a long time to get the material into the patient, so I don't know that that's a strategy that's going to provide a lot of additional competitive advantages for them. The sub-Q side, again, I think the jury's out. I don't think we're overly concerned about it. I think a one-hour infusion every six months is still an extremely convenient way of delivering the product. The SubQ, you know, I think there are issues with that SubQ formulation. I mean, it's been used in a number of other products, some of which have been very successful. Others have been not so successful. So I think the jury is out on that. We'll see how it goes for them. Adam, anything further? Any comments?
spk07: Yeah, I think you covered it, Mike. You know, I think we will wait to see what the actual profile of that looks like and what's required from pre-medication, post-monitoring, you know, that all adds time, you know. But I think what's interesting is that, you know, we do believe convenience streamlining the experience does matter in this market, and it's an important aspect of of the overall experience, both from a, you know, patient perspective, from a convenience, but also from an office perspective. So we believe convenience is important, but we also can continue to believe that, you know, we'll be best positioned for patients who want a quick one hour, twice a year B cell therapy. Okay. Thank you.
spk09: And, and, and you mentioned that you, you know, plans for continued development of Oblutoximab. Can you, following approval. Can you talk about your plans for PMS, aggressive MS, in the future?
spk08: Yeah, so we are exploring that area. I don't think we have any plans to discuss today, but we've certainly been engaging with KOLs to understand what the needs are and what they think would be a successful trial design in that area. Okay.
spk09: And then, uh, last question, I guess, maybe for Adam, I guess, following approval, what will your commercial team look like in terms of the size, the footprint and, uh, um, from, from where it is now?
spk07: Yeah, thanks Matt. We're, we're, we're pretty much, uh, in, in good position, uh, at this point, uh, as I mentioned in our, in our prepared remarks there, we've hit our internal, uh, timelines for, for hiring. And I think what I've said in the past is that our footprint from a field-based perspective is about 80 to 100 people. We feel like this is, as we were talking about with Chris there, we think somewhat of a targeted approach. We think we know where we have to go in order to get the business. MS Centers of Excellence, large community centers is going to be our focus. We think we We have a team that will be more than adequate to cover that, and we're in a good position right now, and we'll be ready for launch and come early next year. Great. All right.
spk09: Thanks a lot, and good luck going into December. Thanks, Matt.
spk02: Thank you. Our next question is from Eric Joseph with J.P. Morgan. Please proceed with your question.
spk04: Good morning. Thanks for taking the question. Can you just expand a little bit on your access strategy from the patient perspective? I'm just curious to know if there's much opportunity to compete with Ocrevus and Cosimta when it comes to co-pays borne by the patient. And then we'd also be curious to get your latest sense of how sensitive payers are to price. And then finally, just on cash position, and Sean noted being capped through 2024, I'm just wondering whether you're considering any financing alternatives to support the launch, perhaps a royalty monetization. Thanks.
spk08: Thanks, Adam. You want to take the first question? Sure.
spk07: Yeah, thanks, Eric. I think we're going to compete very well from a patient access perspective. As I mentioned, we've built a best-in-class patient support program. We will have all of the support initiatives that these companies have. You asked specifically about a copay program. We will have a copay program. And we feel we're in a good position to support practices and patients. And then your second question was around payers and sensitivity to price. I think, you know, what we've heard is that, you know, pairs are interested in inviting competition into the market. They're looking for lowest net cost. And, you know, I think they are sensitive to, I would just say, low net cost. And I think we've gotten feedback from them. We understand where they're at and, you know, have developed an idea of how we want to price this going into the launch.
spk08: Great. In terms of cash position and alternative financings, I think, Eric, we're keeping all the doors open in terms of ideas on how we want to continue to add, but we're not going to be in any rush. We have plenty of money to launch on day one. Obviously, we have money into 24, so not an emergency situation. Obviously, we're not overfunded, but that most of that money would be sitting in the bank anyway while we're getting everything up and running. So I think we're feeling quite good about the cash position, even though it may not look like a whole lot to others. You know, we're expecting to drive some revenues in the first year, which will also extend that 2024 burn number. And we have plenty of options. And yes, royalty and monetizations are are on the table, of course, as are other potential financings, depending on the market conditions when we get to the launch phase.
spk04: Thanks for taking the questions, and also good luck into December. I appreciate it.
spk08: Thanks, Eric.
spk04: Appreciate it.
spk02: Thank you. Our next question is from Mayank Mantani with B. Riley. Please proceed with your question.
spk03: Hi. Good morning, team. This is Sahil Kazmi asking a couple questions for Maya. What are your expectations for the potential labeling interactions as we're getting closer to the PDUFA date, and how the warning section could be differentiated from a crevice, for example?
spk08: Yeah, so thanks for the question. So in terms of we did disclose earlier that the labeling discussions have commenced, but that we're not going to provide any further callers. I don't know that I have anything more to add. And same thing as it goes to... That's the second part of your question.
spk03: Okay, great. And then just on the recent ISA report that came out, just any of your kind of top-line thoughts and how you're navigating through some of the payer discussions more broadly maybe for Adam as well?
spk08: Yeah, I'll lead off and let Adam take over. But the ISA report, you know, we obviously are reviewing, continue to review it. We'll probably have some. some comments on it, um, official comments at some point soon. Um, but generally speaking with ICER's role is to try to, uh, influence how we price the drug. There's, there was, there was a clear reason why they put that report out, uh, before we launched. Um, I mean, the whole report was all about, in my opinion, getting us to try to affect how we think about pricing. Uh, as you know, we've always been thinking about coming in at a lower price point. Um, so it's not, uh, That borrows us the concept, but I think some of their analysis are skewed in certain ways just to make a point. But I'll let Adam maybe address the overall payer access environment.
spk07: Yeah, I think with regards to the IC report specifically, our view is that we don't think it's going to affect our access. And, you know, payers haven't really reacted to it. and we feel good about the value proposition we're bringing with Upatuximab and feel good about our payer strategy and, you know, what we're thinking about from a pricing perspective and feel confident, as I mentioned in the remarks, that, you know, we don't foresee major issues with reimbursement and coverage.
spk03: Excellent. Thanks a lot for taking our questions, and best of luck for the PDUFA.
spk08: Thank you.
spk02: Thank you. Our next question is from Prakhar Adrewal with Cantor. Please proceed with your question.
spk01: Hi, good morning, and thanks for taking my questions, and congrats on all the progress. So, firstly, a quick clarification. If you can remind us if there are any inspections left for the FDA, and also if you could talk about your readiness in terms of drug supply at launch, and I had a follow-up.
spk08: Yeah, so... Again, we haven't provided any color on inspection, so I'm going to pass on that question. And what was the second part?
spk01: Readiness in terms of drug supply at launch.
spk08: Yeah. Yeah, we have plenty of drug supply for launch. We have a large manufacturing arrangement with Samsung Biologics, and we're comfortable with our launch supply.
spk01: Okay. And secondly, Mike, you mentioned you presented the data several times over the past few months. So talk about what you're hearing from specialists on what really gets them excited about OOBLI, some of the key factors, and also what's their willingness to switch loyalty from Oak Rivers. Thank you.
spk08: Sure. Thanks for the question. So, you know, when we go around and talk to physicians, I think our goal is to just present the data as it exists. We think the data speaks for itself, and what we find is that different clinicians will resonate toward different aspects of the data set. Some folks will look at the annualized relapse rate, and although we don't compare to other drugs in the class or the drugs outside the class other than terflutamide, many physicians will look at it and say, well, this is by far the best annualized relapse rate, and I want to have the best for my patient, and they believe that this is the best. Others will look at the data, and they'll be impressed with the tolerability and speed in which we can deliver the infusion. So it's not just about the one-hour infusion. It's about the consistency to deliver a one-hour infusion and the tolerability. Okravis continues to have, in later lines of infusion, continue to have relatively high rates of infusion reactions, upwards of 20%, 25%, even as of the third or fourth infusion. So where we're down by the third infusion, I think we're around 5% or something. So I think tolerability is one people have resonated toward. Again, we don't compare. We don't make the comparisons, but the folks will do their own comparisons in their head. And then the one-hour infusion, obviously, from a patient convenience standpoint, a practice convenience standpoint, a lot of folks will resonate toward the one-hour infusion. So I think it's a mixed bag. Our job is just to make sure we present the facts and only the facts, and folks will do their own internal assessments of how they view the data.
spk01: Thank you. I'm looking forward to the update in December.
spk08: Thank you.
spk02: Thank you. There are no further questions at this time. I'd like to hand the floor back over to Mike Weiss for any closing comments.
spk08: Great. Thank you. And thanks, everyone, again, for joining us this morning. As discussed multiple times today on this call, with the target PDUFA action goal date of December 28th, our primary focus is and remains working toward an approval for ilbituximab for patients with relapsing forms of multiple sclerosis and if approved, being prepared to launch early next year. Again, if approved, we believe oletuximab could be a meaningful treatment option for patients with RMS. We believe treatment options are essential when it comes to treating chronic illnesses like MS, and we are committed to supporting the MS community. Thanks again for joining us this morning, and have a great day.
spk02: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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