Greetings. Welcome to TG Therapeutics conference call and webcast. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 0 from your telephone keypad. Please note this conference is being recorded. At this time, I'll now turn the conference over to your host, Jenna Bosco. Jenna, you may now begin. Thank you. Welcome everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the U.S. Food and Drug Administration's approval of BRIUMVI are Michael Weiss, our Chairman and Chief Executive Officer, Dr. Lawrence Steinman of Stanford University, Dr. Bruce Cree of UCSF Weill Institute for Neurosciences, and Adam Waldman, our Chief Commercialization Officer. Mike will begin today's call by providing some introductory comments and context around the FDA approval of BRIUMVI, following which Doctors, Steinman and Cree, will share the data which supported the approval and provide an overview of the prescribing information. Lastly, Adam Waldman will join us to discuss our launch and commercialization plans before we turn the call over for a Q&A session. We kindly ask everyone to limit yourself to 1 or 2 questions. Return to the queue if you have additional questions. For those of you joining via conference call, please note slides have been made available via webcast and can be accessed on the investor section of our website at www.tgtherapeutics.com. Additionally, we issued a press release yesterday detailing the approval of BRIUMVI, which can also be accessed on our website. Before we begin, I'd like to remind everyone that various remarks that we make about our future expectations, plans, and prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks that may c ause 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 most recent Form 10-Q and other filings with the Securities and Exchange Commission. 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. As a reminder, this call is being recorded for audio rebroadcast on TG's website, where it will be available for the next 30 days. All participants on this call will be on a listen-only mode. Now, I would like to turn the call over to Mike Weiss, our Chairman and CEO. Great. Thanks, Jenna, and thanks to everyone for joining us on today's call. Today is obviously an extremely exciting day for everyone touched by MS and everyone that has worked on the development of ublituximab, now known commercially as BRIUMVI. I'd like to start today's call by thanking those that helped us get here, starting with the brave patients and their families, the clinical investigators and study staff who participated in our studies, as well as the entire TG team for their dedication and tireless efforts over the years. I also want to thank our advisors for their help as we've developed BRIUMVI and also who have helped us shape our commercial plan. On the next slide, I am more than pleased to report that BRIUMVI is now approved to treat adult patients with relapsing forms of multiple sclerosis, which includes clinically isolated syndrome, relapsing-remitting disease, and secondary progressive disease. With yesterday's regulatory decision, BRIUMVI becomes the first and only anti-CD20 monoclonal antibody that can be administered in a 1-hour infusion 2 times a year following the starting dose. Too often, MS is diagnosed in young adults just when they are starting their careers or considering starting a family. We believe the attributes of BRIUMVI create an attractive treatment option to those patients and with relapsing forms of MS, including BRIUMVI's efficacy with less than 1 relapse for every 10 patient years, as was seen in our phase III ULTIMATE I and II studies, its safety profile, and its convenient 1-hour infusion 2 times a year administration following the starting dose. Adam, our Chief Commercialization Officer, will join us shortly to tell you more about our initial launch approach. I just want to say that I have the utmost confidence in the fantastic team we have assembled and also in BRIUMVI's ability to become a meaningful treatment option for patients with the relapsing forms of MS. We cannot be more thrilled to make this therapy available to patients as soon as possible. As noted in the press release, we are targeting a Q1 next year launch of BRIUMVI. Ideally, we will have BRIUMVI at the centers within 30-45 days into the new year. Finally, before I turn the call over Dr. Steinman, I wanted to cover a little financial housekeeping here. We expect to end the fourth quarter with approximately $175 million in cash, which reflects another quarter of disciplined spending with four quarter burn of approximately $25 million. With yesterday's approval, we also have the ability to draw up to $45 million from our Hercules facility, which in so doing, would leave us with a pro forma cash balance sheet at year-end of this year of approximately $220 million, which we believe will take us approximately into the middle of 2024, perhaps even further, depending on the extent of revenues over the next 18 months. Accordingly, we believe we are sufficiently capitalized to execute on our launch plan without the need to raise additional capital at this time. With that, let me introduce our next two speakers. First up will be Dr. Lawrence Steinman, the global study lead of the ULTIMATE I and II phase III trials and a Zimmermann Professor of Neurology, Neurological Sciences, and Pediatrics at Stanford University. Dr. Steinman will join us to share additional context about BRIUMVI, as well as the efficacy data that supported the approval. He will be followed by Dr. Cree, a longtime advisor of ours and a Zimmermann Endowed Professor in Multiple Sclerosis and Professor of Clinical Neurology at UCSF Weill Institute for Neurosciences. Dr. Cree will join us to provide information on the safety data and provide a review of the BRIUMVI label. In advance, I'd like to thank both Dr. Steinman and Cree for their leadership with respect to our ULTIMATE phase II program and overall guidance and support from our early development of BRIUMVI through the FDA process. With that, let me turn the call over to Dr. Steinman. Thank you, Mike, and congratulations on the approval. Hello, everyone. I am Dr. Larry Steinman of Stanford University, and I was the global study lead for the phase III ULTIMATE trials which supported the approval. As many of you know, I've been involved in the development of ublituximab since the very early days as an advisor, and to have reached the point of approval is extremely gratifying and most importantly, a fantastic outcome for patients. I've dedicated myself to helping patients with multiple sclerosis and other autoimmune disorders, and I've spent my time not only treating patients, but researching and understanding the science of these diseases to determine what the best course of treatment might be. Today, I have the pleasure of reviewing with you some of the basic science behind ublituximab, as well as the efficacy data that supported the approval. Following which my colleague, Dr. Cree, will review the safety data from the ULTIMATE I and II phase III trials. Let's go to the next slide. Okay, let's get started and discuss a bit about ublituximab or BRIUMVI, as it is now commercially known. As you can see on the slide, BRIUMVI is a novel anti-CD20 monoclonal antibody that targets a unique epitope on the CD20 antigen. It is now the first and only anti-CD20 monoclonal antibody that can be administered in a 1-hour infusion twice a year following the starting dose. Let's go to the next slide. Interestingly, BRIUMVI has also been glycoengineered to enhance affinity for NK effector cells, leading to efficient B-cell depletion at low doses. Let's go to the next slide. I started my presentation discussing a bit about the design of BRIUMVI, and now I would like to review some of the data from the ULTIMATE I and II phase III trials that supported the approval, which I was pleased was published earlier this year in The New England Journal of Medicine. Let's start with a review of the trial design for the ULTIMATE studies. As you may recall, the efficacy of ublituximab was demonstrated in two identical randomized double-blind clinical trials in patients with relapsing forms of MS, treated for 96 weeks compared to oral teriflunomide. A total of 545 patients were treated with BRIUMVI across these two trials. The starting dose of ublituximab included a 150 mg infusion administered over 4 hours on day one, and then a 450 mg infusion administered over 1 hour, two weeks after the first infusion. Subsequent doses of 450 mgs were administered in 1 hour every 24 weeks after the first infusion. Let's go to the next slide. The primary endpoint for these trials was annualized relapse rate or ARR, and the results showed that BRIUMVI significantly suppressed relapses with 59% and 49% reductions in ARR seen in ULTIMATE I and II respectively for BRIUMVI compared to oral teriflunomide. These data translate to less than one relapse for every 13 patient years with BRIUMVI in the ULTIMATE I trial, and less than one relapse for every 11 patient years with BRIUMVI in the ULTIMATE II trial. As I have noted before, this was the first phase III program of an anti-CD20 to result in an annualized relapse rate below the 0.1 threshold, representing what I believe to be an important barrier to have crossed, and importantly, fantastic news for patients with relapsing forms of multiple sclerosis. Let's go to the next slide. We move on now to several secondary endpoints that were assessed, and the results continue to impress me. As shown by MRI, BRIUMVI had a profound effect on T1 gadolinium-enhancing lesions at week 96, with 97% reduction in gadolinium-enhancing lesions seen in both studies for BRIUMVI treated patients compared to teriflunomide. Let's go to the next slide, please. Similarly, new or enlarging T2 lesions at 96 weeks were reduced by 92% for BRIUMVI versus teriflunomide in ULTIMATE I, and by 90% BRIUMVI versus teriflunomide in ULTIMATE II. Let's go to the next slide, please. Lastly, before handing the call over to my colleague Dr. Cree, which I believe will be reviewing key aspects of the U.S. prescribing information, including the safety profile of BRIUMVI, I wanted to review the confirmed disability progression or CDP at 12 weeks observed in the ULTIMATE trials. While the differences in CDP between trial arms did not reach statistical significance, 5.2% of BRIUMVI treated patients had confirmed CDP at 12 weeks, compared to 5.9% in patients with teriflunomide, indicating a low rate of progression overall in this study, which I believe can be expected with the low annualized relapse rate observed in the trial. As I have shared before, I am extremely proud to have helped the TG team along the way with the development of this drug, and I am thrilled that it is now approved by the FDA. Patients are always in need of treatment alternatives, and I believe BRIUMVI offers unique attributes, which makes this an exciting day for patients with relapsing forms of MS. With that, I will hand the call over to my colleague, Dr. Bruce Cree. Thank you very much, Dr. Steinman. Hi, everybody. I'm Dr. Bruce Cree from the University of California, San Francisco, Weill Institute for Neurosciences, and I'm happy to join you on the call this morning. I've worked closely with the TG team now for many years on the development of BRIUMVI. I wanted to extend my congratulations to the team. Well done, everyone. Patients are always in need of better treatment options. Accordingly, today it's a great day for all of those who are affected by MS. I'm pleased to join the call this morning and provide an overview of the prescribing information for BRIUMVI as well as review of the safety profile. Next slide, please. What you can see here is a synopsis or highlights of the prescribing information on BRIUMVI. As mentioned by others this morning, BRIUMVI is now approved for treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS in adults. The recommended dosing is identical to that studied in the ultimate phase III program and consists of a starting dose which includes a 150 milligram infusion over 4 hours and 2 weeks later by a 1-hour 450 milligram infusion, with all subsequent infusions also being 1-hour 450 milligram infusions that are spaced 24 weeks apart. In terms of BRIUMVI's administration, there are some important points to highlight. The recommended pre-medication with the corticosteroid and antihistamine has the flexibility to be given either intravenously or orally. The standard 1-hour post-infusion monitoring that we are used to doing for many other monoclonal antibodies is at the physician's discretion after the first 2 infusions for patients that did not experience an infusion reaction or hypersensitivity reaction on previous infusions. Next slide. Here I want to touch on some of the noteworthy salient aspects of the warnings and precautions with the BRIUMVI label. These include infusion reactions, which I will go into in more detail shortly. Infections and reduction in immunoglobulins, which you would expect with the B-cell depleting therapy with this mechanism of action. Of course, this is just a highlight. I suggest everyone read the full prescribing information which can be found now on the TG corporate website. Next slide, please. Thank you. Here I want to discuss the adverse event profile of BRIUMVI as contained in the label, as is consistent with what was published in The New England Journal of Medicine paper. First of all, I would say overall that the safety profile of BRIUMVI has been well established in the ULTIMATE trials. As noted on this slide, infusion-related reactions and upper respiratory tract infections were the most commonly observed adverse reactions and were the only AEs observed in greater than 10% of patients in the ULTIMATE trials. Overall, the rate of infections in general was about the same for BRIUMVI compared to teriflunomide, with a slightly higher rate of serious infections seen in BRIUMVI-treated patients, 5% versus 3%. Next slide. In my last slide, I want to speak a little about infusion reactions since they are the most common adverse event. The infusion reactions seen in the ULTIMATE studies were mostly mild to moderate in severity. As you can see here from this figure, they occurred predominantly at the first infusion and decreased with subsequent infusions. Interestingly, 90% of the planned 1-hour infusions within the ULTIMATE trials were in fact completed with 1 hour, without interruption. This was highlighted with The New England Journal of Medicine publication. At this time, I'll hand the call over to Adam Waldman from TG to continue the discussion, and I'll be available during the Q&A to address any questions. Adam? Thank you, Dr. Cree and Dr. Steinman, good morning, everyone. First, let me start by thanking and congratulating my TG colleagues who have worked so hard for so many years to make this day possible. This approval is an incredibly exciting achievement for TG, more importantly, represents a great day for individuals with relapsing forms of MS. MS is a debilitating and chronic disease that can have a significant impact on patients and their families. It is with this in mind that we are extremely motivated to work with the MS community to launch what we believe is the next evolution of B-cell targeted therapy. Next slide. The anti-CD20 class of drugs has transformed the treatment landscape for patients with relapsing forms of MS. Every year in the U.S., there are approximately 80,000 patients that are either newly diagnosed or switched to a new therapy. Today, approximately 50% or one of every two of these patients will go on an anti-CD20 therapy. This trend has grown overall market share of the CD20 class dramatically over the last five years, and now there are well over 100,000 patients that are currently on an anti-CD20 therapy in the U.S. With this approval, we believe BRIUMVI brings a potentially best-in-class profile to what is now the most widely used class of drugs in the MS market. Next slide. BRIUMVI is the next evolution of B-cell targeted therapy, engineered for efficient B-cell depletion at low doses. It is the first and only CD20 therapy that is administered as a twice yearly one-hour infusion following the starting dose, and is now FDA approved with a broad label for patients with relapsing MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Next slide. Feedback from our market research with neurologists, advanced practitioners, infusion centers, and patients provides us confidence that BRIUMVI's profile offers compelling benefits to patients, providers, and payers by combining the convenience of the twice-yearly one-hour infusion with the lowest reported annualized relapse rate for an anti-CD20 agent in a phase III trial, a well-established safety profile, no reported cases of breast cancer, and the predictability of a one-hour infusion that was delivered 95% of the time without interruption in clinical studies. Next slide. We believe BRIUMVI has the potential to change the experience of using a B-cell depleting therapy. The flexible pre-medication regimen, which includes the option of using oral administration, the twice-yearly one-hour infusion, and no requirement for post-infusion monitoring after the first 2 infusions if prior infusion reaction or hypersensitivity were not seen, offers more flexibility for patients and physicians. For patients, we have heard they want high efficacy therapy and prefer the convenience of a twice yearly regimen, so they don't have to think about their disease on a monthly or daily basis. If given the choice, most would prefer a shorter infusion experience. For providers, especially those with infusion centers, they also want high efficacy options that balance safety, but also offers an efficient and predictable infusion option. Heard that infusions provide physicians confidence knowing that their patients are being compliant with therapy. Payers want high efficacy options in this market and have been enthusiastic about more competition in this space, but want to keep the cost down. Here, less is more. Next slide. We have built a truly exceptional team to support the launch of BRIUMVI. The team is hired, fully trained, and prepared to execute. We now have over 80 field-based employees with an average of 12 years of MS experience, and each has launched an average of 2 MS products. Our field teams have vast networks throughout the MS community and will be dedicated to rapidly educating healthcare practitioners in the community and academic settings. Next slide. The MS market is highly concentrated, with 70%-80% of the approximately 350,000 treated patients each year opting to see an MS specialist at 550 centers across the country. We believe this dynamic will allow us to be highly effective with a small, focused, and experienced field team. We will have a targeted approach to launch with highly coordinated execution plans focused on MS specialists at large community practices and major academic centers where we know there are high volumes of patients and high volumes of CD20 utilization. We are prepared to ensure that patients and healthcare providers in these centers have a positive first experience with the necessary education, support, and resources. Next slide. As a team, we are deeply committed to ensuring that patients who can benefit from BRIUMVI have the opportunity to do so. We understand the urgency needed to educate and drive awareness of this important new treatment option, therefore are focused on 3 simple priorities to drive on launch. First, drive initial utilization with our high volume targeted customers. Second, minimize patient access barriers, ensuring access is simple and easy to make sure our patients have a positive first experience. Third, accelerate broad awareness of BRIUMVI through the MS patient community, which we believe we can target effectively with multi-channel digital media efforts. Next slide. At TG, our commitment and dedication to patients goes beyond the product. We believe that access is essential to ensuring the advances are available to patients who are in need of treatment options. We are committed to supporting patients in accessing BRIUMVI, which is why we built a comprehensive patient services program called BRIUMVI Patient Support. The program includes a dedicated team to provide patients with access and reimbursement support, financial assistance programs, and a quick start program for those eligible. Additionally, we believe our preparation and high level of engagement with payers prior to launch will help ensure we can unlock access efficiently and will be added to formularies as rapidly as possible. As we prepared for the launch of BRIUMVI, we listened carefully to the MS community, including neurologists, patients, payers, and advocacy groups. Many of these stakeholders shared their concerns regarding the current pricing of MS therapies and the difficulties patients have accessing these therapies. This is why we built this comprehensive patient services capability and also kept this feedback in mind as we considered how to price BRIUMVI with the goal of optimizing access for patients. Next slide. This is why we are proud to be launching BRIUMVI at the lowest price branded disease-modifying therapy approved for patients with MS. The annualized maintenance price will be $59,000 or $9,833 per vial. As a company, we are committed to responsible pricing and partnership across the healthcare system. We are focused on reducing the burden to the system to support patients in accessing our medicines. We have received very positive feedback from payers on the clinical profile of BRIUMVI and our responsible pricing approach. We do therefore anticipate early coverage decisions from several national and regional health care plans in quarter one of next year. We believe the clinical value and the price of BRIUMVI will unlock access for MS patients. Next slide. In summary, we are incredibly excited to launch BRIUMVI. We have built an incredible team, which we believe has more pound for pound MS experience than anyone in the industry. These teams could not be more excited to launch this drug and have already begun actively engaging key stakeholders in the MS community with the exciting news of our approval. As Mike mentioned, our plan is to have BRIUMVI available to customers in Q1 of next year, ideally ready for first patients to be infused within the first 30 to 45 days of the new year. We believe we have the product, passion, and people to be successful. We also 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 move forward with urgency as we know BRIUMVI is an important new option for patients managing this debilitating disease. Thank you for your time. Now I'll hand the call back over to Mike. Thanks, Adam, and thank Dr. Cree and Lawrence Steinman. We're going to turn the call over to conference operator to start the Q&A. Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question today, please press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. So that we may address questions for as many participants as possible, we ask that you please limit yourself to one question and one follow-up. If you have additional questions, you may re-queue, and time permitting, those questions will be addressed. One moment please while we poll for questions. Once again, that's star one from your telephone keypad. Thank you. Thank you. Our first question will be coming from the line of Ed White with H.C. Wainwright. Please receive your questions. Good morning, everyone, congratulations on the approval. Thanks, Ed. So, um- Appreciate it. You're welcome, Mike. Dr. Steinman and Dr. Cree, perhaps you can just tell us your thoughts on what is the most important characteristics of BRIUMVI when thinking about prescribing the drug. Is it going to be the price? Is it going to be the efficacy, the ARR? Or is it going to be the infusion time or any other characteristics? New England Journal paper shared that there was no evidence of any disease activity in about 45% compared to 15%. Frequently at 12 weeks when you make this a very attractive monoclonal antibody on CD20 to present. The quick infusion times are really going to be important for individuals. As Mike Weiss mentioned, it affects young adults. These are people starting their families, moving ahead in their work fields and getting in and out for those infusions twice a year is going to be another major selling point. Bruce, what ideas do you have? Larry, I think you hit all the key points. I don't think there's just one feature about this particular product that is going to distinguish it. I see it as an improvement over other anti-CD20 monoclonal antibodies that we commonly use in clinical practice for treatment of MS on several levels. you know, I think you hit all the key ones. I would also say that patients after infusion who haven't had prior infusion reactions can be discharged without ongoing 1 hour of observation is another feature that, as you mentioned, makes getting in and out of the infusion center a quick process. I think that's gonna be attractive for patients as well as those who are administering the medications through their infusion centers. Great. Thank you. Thanks, Ed. Perhaps a follow-up question. Yeah, go ahead. Just for Mike. When thinking about next steps for development, just wanted to get your thoughts on primary progressive MS studies, and also any thoughts you can give us on the European approval and marketing there? Thank you. Sure. Thanks, Ed. On further development, you know, the team is working closely with our advisors to determine whether a full-blown primary progressive study makes sense or not. One CD20 has done that trial that's approved. The other CD20 that's approved has not done that trial. We're evaluating with the experts and at some point we'll have an answer for that. In terms of the ex-US, I think we're about six months to nine months behind this approval for a potential approval in the EU. Okay. Thanks, Mike. Thank you, Ed. The next question is from the line of Mayank Mamtani, B. Riley Securities. Please proceed with your questions. Good morning, team. Congrats on the approval, and thanks for taking our questions. Maybe just for first for Dr. Steinman and Dr. Cree. You know, just reviewing the label, relative to currently approved anti-CD20s, it does look, you know, very comparable just on the high level. Was there anything that you'd highlight as you may have done the same comparing to Ocrevus and Kesimpta? Then just one specific question on the immune-mediated colitis AE rate. Do we know what that was in ULTIMATE one and two? Then I have a follow-up for Adam. Yeah, I'll try and field this. I think one always has to be very careful about comparing products in a direct way. Of course, ublituximab was compared to teriflunomide, and we have the data on that, but we don't have a direct comparison of ublituximab to ocrelizumab or ublituximab to ofatumumab. When you kind of look across these labels, you have to do so with a degree of caution. Each label is written in a way intended to address that particular product, not so much to situate it in context of everything else that's out there. As you alluded to, there is a sense when you read through the label that there were no surprises here. In particular, some of the adverse events that have been associated with ocrelizumab that are in the ocrelizumab label are either not present in the ublituximab label, like the colitis, or are not as prominently displayed in the label, such as PML risk. Although that is part of the label and something that we know does occur. It has been observed with ocrelizumab in at least one case, which was a true related case. So far, of course, we haven't seen any such cases with ublituximab. I think this is most likely a numbers game, and when you get to a high enough patient volume, it is entirely conceivable that we're gonna see cases of PML. Generally speaking, I would say the other nice feature about the BRIUMVI label is that there isn't any cautionary words around malignancy. I think that has been an issue for many of our patients with ocrelizumab treatment, especially since many of our patients that are young women. The concern for breast cancer is a very real one. It's an emotionally laden one. Since that does not appear in this label, I think that is a positive feature. Larry, anything else that you would wanna add about the safety? Bruce, I think that covers the points I would make. Thank you. Thank you. Then, just a quick follow-up for the company or Adam. In terms of launch metrics, you know, pertaining to reach and frequency as well as, you know, payer coverage, how sort of, you know, you're looking for that in the next two quarters, if you could provide any granularity. Then, specifically for the ICER, you know, January 20th meeting coming up, any sort of preparations with this price point and, you know, how you might be thinking about gross-to-net pricing. If you could comment on that'd be great. Adam, you wanna go ahead? Sure. Mayank, we'll absolutely give you the metrics as we get going here, the standard metrics that you would expect. You know, I think we'll be able to cover, you know, the things that we think are important. I don't have a list of those right now for you. You know, you can expect us to give you the standard information that is pertinent to any launch. As for I think your second question has to do with ICER. Yes, there is a meeting coming up in January 20th. Yes, we are preparing to for that meeting. You know, so far the ICER report has not, you know, had a big impact with payers. We will continue to work with the organization as we see fit, and we're very proud of our pricing and the way that we've approached this. I can't remember what other. You had some other follow-ups there, but I can't remember what they were. Yeah, just quickly on the gross-to-net price. How should we think about and, you know, how is the market currently with other antis too, so CD20 works and how you might be thinking about it? Yeah. We're not prepared to give any guidance on gross to net today. As you know, it's pretty fluid, especially in a launch period. Certainly in the calls that we have coming up, we will update you as we get more visibility into the gross amount. Thanks for taking our questions. Thank you. Thank you. The next question is from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your questions. Hi. Good morning and congratulations on the approval. My first question is on, is for Adam. On the pricing, the list price is obviously lower than even Ocrevus' ASP. Maybe if you can talk about how the provider economics and reimbursement of ASP plus 6% factored into your pricing decision. I had a follow-up. Yeah. You know, as we always said, we wanted to price BRIUMVI for access. We vetted our price with national and regional payers. We want to ensure, as Dr. Steinman just said, we could have the greatest drug in the world, but if people can't access it doesn't help. We wanted to first and foremost make sure that we could get access. As far as, you know, the providers go, you know, you have to look at ASP plus reimbursement, but there's also other things to consider, such as cash, you know, outlay. Of course, you know, many physicians have told us they're concerned about patient costs, and a lower price in some cases can lower the out-of-pocket, especially for patients with co-insurance. You know, I would say there's, as we talk to many physicians and centers, throughput is also efficiency, especially for centers that are capacity constrained. Many of these high volume centers have reported that they are capacity constrained, and therefore the efficiency of a one-hour infusion and the added efficiency does help them to think about how to think about BRIUMVI. I think all those things were considered as we priced the drug and as we said, we feel very comfortable with where we're at right now. Thank you. Maybe as a follow-up, where do you see the uptake predominantly happening in the first year of launch? Presumably, you talked about the dynamic patients, newly diagnosed plus switch. There seems to be already high penetration of the CD20 class in the late line switching patients, and typically doctors would take time to get comfortable with the drug before using it in newly diagnosed. Any color you might provide, you can provide on the patients, where you will see the most uptake in the first year of launch. Thank you. Yeah, sure. you know, I think we. Hello? Yeah. Thanks, Mike. Yeah, we would expect, you know, our, our hypothesis is that the initial use of BRIUMVI will come from patients switching from non CD20 therapies. You know, we think we can compete for that against the other CD20s quite well. You know, there have been many physicians who told us they would consider switching from a CD20 to BRIUMVI. We'll have to watch that. It's not our not where we think the bulk of the business will come, but we certainly think there will be some folks that switch from anti-CD20s. Then, yeah, you know, listen, doctors will have to figure out. Our sense is that they are interested in trying the drug, and interested in seeing the experience for themselves, and then they'll figure out where the best place to use it is. Thank you, and congrats again. Can I add something to that one, Adam? I think it's... Sure, sure. This is Bruce Cree. I think it is gonna be very interesting to look at this, right? Because what we don't have at this point is data on transitioning a patient from one anti-CD20 to another. Of course, none of the participants in this clinical trial had prior exposure to anti-CD20s coming in. What we don't know is if you take a patient, for example, on Ocrevus, who's has frequent infusion reactions and has to have a slower infusion, which occurs in many patients, whether that individual were switched over to ublituximab, whether they would have a better infusion experience. I think that's a very important question to address. We don't have data on that yet. I think once data is generated, wouldn't it be interesting if we knew that many of those individuals who required a 4-hour infusion with Ocrevus could get away with the 1-hour infusion with ublituximab? I think if we had that information, that would make it extremely attractive, especially for those individuals who have a longer, slower infusion experience. Yep. Thanks, Dr. Cree. Yep. Our next question is from the line of Matthew Kaplan with Ladenburg Thalmann. Please proceed with your question. Hi. Good morning. Congratulations on the approval. Terrific news to end the year here. Just want to follow up, I guess maybe with Adam, question on access and how we should think about over the course of 2023, the access that patients will have based on coverage by the major plans and the rollout of that over the year. How should we be thinking about that? Yeah. Matt, thanks for the question. you know, we anticipate the majority of payers will cover BRIUMVI in the first half of 2023. As I mentioned in the prepared remarks, we could see some payers even in quarter one. you know, our expectation is in the first six months, the majority of payers will cover BRIUMVI in 2023. Okay. That's really helpful. Then, you kind of laid out the dynamics of the market with 80,000 patients newly diagnosed and switching to therapies. Then, you know, 50% of those coming onto anti-CD20s. Can you kind of tease that out a little bit more with respect to, of those 80,000 patients, the number that are de novo starting on anti-CD20s and the percentage of and the number that are switches that go on to CD20s? Matt, I don't have that information at the, at the top, of my mind here. I don't. I can get that information for you, but I don't have it right now. Okay. That's fine. actually, no. Sorry. Hold on one second. Sorry, Matt. I just got texted. It looks like it's just in. It's about 40% that are naive and 60% that switch for the CD20. I guess based on Adam, your prior comments, what's your sense in terms of being able to grab market share of the naive patients, versus the switching patients? Yeah. I think we'll be able to grab market share in both, you know, in both settings. I think we are targeting physicians that are comfortable using CD20s, have been using a lot of, you know, both Ocrevus and Kesimpta. We're purposely going after those folks given those physicians comfort with the class. You know, we think that is a great place to start, and we do think that those physicians will be comfortable using ublituximab. Great. Then maybe a question for Dr. Cree and Dr. Steinman. When your patients are choosing between the different anti-CD20 therapies, what really drives their decision in terms of looking at Ocrevus, which is IV or Kesimpta which is SubQ? How do you think BRIUMVI fits into that scheme in terms of the choice of between the different anti-CD20 therapies? Yeah, that's a great question, and it's an interesting one, and it's one that I'm a bit surprised by. you know, now that we've had ofatumumab on market as Kesimpta for MS for quite some time, it has gradually acquired a bit more of the market share over time, but not nearly as much as I would have anticipated. I'm a bit surprised, but in MS, a lot of people seem to prefer, even when given the option to have a at home SubQ injection, they seem to prefer with respect to ocrelizumab, coming into an infusion center and getting infused twice a year. In our practice, I have routinely offered, Kesimpta to all of my Ocrevus treated patients, and I've had some switch over, but nowhere near the amount that I would have thought would have occurred. From that perspective, it does seem that the twice a year infusion is a very attractive option for many individuals. Now with ublituximab, BRIUMVI offering a twice a year shorter infusion experience, I think that is gonna be very attractive for many patients. This is Larry Steinman. I just wanted to add that, perhaps unexpectedly, there's a social benefit to some, and it's unexpected to me, of coming into the center, having, being greeted, talking to healthcare professionals, before, during, and after the infusion. I f it's not intrusive on one's schedule, twice a year shouldn't be intrusive, there's a positive social benefit as compared to injecting oneself, and not having anyone reaching out and having some human contact. I wouldn't have imagined that, but I think it's something to consider in a positive way about infusion. Great. Well, thanks again, and congratulations on the approval. Thanks, Matt. Thank you. At this time, we've reached the end of the question and answer session. I'll turn the call over to Mike Weiss for closing remarks. Excellent. Thank you. Thanks again everyone for joining us this morning. As we have expressed here today, we are extremely grateful to the patients and investigators that participated in the clinical program that led to our approval. Now we are excited to make BRIUMVI commercially available. As noted earlier, we expect to have BRIUMVI on-site ready for infusion in quarter one of next year, ideally as early as 30-45 days into the new year. In terms of goals for 2023, pretty simple. Our plan is to successfully launch BRIUMVI. As our second launch, we feel well positioned to succeed in this effort. We have brought on an extremely talented and experienced MS commercial team and an extremely talented and experienced MS medical team, and I have the highest level of confidence in their capabilities. With that, we'll conclude the call and thank everyone for their participation this morning. Have a great day. Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.