TG Therapeutics, Inc. (TGTX) Earnings Call Transcript & Summary

Greetings, and welcome to the TG Therapeutics ULTIMATE I & II Top Line Data Release Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Jenna Bosco. Thank you. Please go ahead.

Thank you. Good morning, everyone, and thank you for joining us today to discuss the positive top line results from the ULTIMATE I & II trials. I'm Jenna Bosco, TG's Senior Vice President of Corporate Communications, and I welcome you all to our conference call today. Following our safe harbor statement, Michael Weiss, our Executive Chairman and Chief Executive Officer, will review the top line results announced this morning, and then turn the call over to Dr. Larry Steinman, our Phase III Study Chair; and Dr. Ed Fox, our Phase II Study Chair and a Principal Investigator on our Phase III program, who will reflect on today's outcome. 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 for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors and uncertainties that can be found in our SEC filings. 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. [Operator Instructions] Now I would like to turn the call over to Mike Weiss, our Executive Chairman and Chief Executive Officer.

Thank you, Jenna, and good morning, everyone, and thank you for joining us. Today marks another very exciting day for all of us here at TG. It's been a remarkable 2020 for our company. We are thrilled, literally thrilled to share with you the ULTIMATE I & II Phase III trial results, evaluating the ublituximab monotherapy in patients with relapsing forms of MS and announcing that they have both met their primary endpoint, with ublituximab treatment demonstrating a statistically significant improvement in annualized relapse rate over teriflunomide. As disclosed in the press release, annualized relapse rates for ublituximab in both studies were below 0.10. And the relative benefit seen versus teriflunomide was approximately 50% in 1 study and approximately 60% in the other, with both studies having a p-value of less than 0.005. Data for safety and secondary endpoints are still being prepared for analysis, and thus, have not been analyzed at this time. We look forward to presenting the detailed complete data at a major medical meeting in the first half of 2021. Additionally, we plan to use these data to support a BLA submission to the FDA for ublituximab to treat relapsing forms of MS, which is targeted for the middle of 2021. As a reminder, ULTIMATE I and ULTIMATE II studies are 2 independent Phase III trials. Each trial was a randomized, double-blind, active-controlled, global multicenter trial, evaluating the efficacy and safety of ublituximab compared to teriflunomide in subjects with relapsing forms of MS. These trials were conducted under Special Protocol Assessment agreement with the FDA. As presented at ECTRIMS in 2019, the ULTIMATE I & II trials enrolled a total of 1,094 patients with relapsing forms of MS across 10 countries, and the baseline characteristics of patients enrolled in each of the trials appear to be consistent with typical RMS patients. The primary endpoint for each study is annualized relapse rate following 96 weeks of treatment and secondary endpoints include total number of T1gadolinium-enhancing lesions, total number of new and/or enlarging T2 hyperintense lesions and time to confirmed disability progression or CDP. The ULTIMATE trials evaluated a 450-milligram dose of ublituximab administered via a 1-hour IV infusion every 6 months, following a day 1 IV infusion of 150 milligrams of ubli, administering a 4-hour infusion and a day 15 IV infusion of 450 milligrams of ubli administered as a 1-hour infusion. The control arm was 14 milligrams of oral teriflunomide taken daily. We believe the ability to infuse the 450-milligram dose of ublituximab in 1 hour every 6 months provides a unique point of differentiation from the currently approved CD20 and may offer a meaningful improvement for patients suffering from this chronic and debilitating disease. In addition, as we have said in the past, we'd like to strategically price ublituximab to enhance patient access. The CD20 class plays a vital role in the treatment landscape for MS and is expected to grow to approximately $10 billion in global sales by 2025. We believe ublituximab, if approved, will be an important anti-CD20 treatment option for patients with relapsing forms of MS. We are so excited by these results today as they bring us one step closer to getting ublituximab to MS patients who continue to have a need for additional treatment options. I want to thank our ULTIMATE I and II Study Chair, Dr. Lawrence Steinman, the Zimmerman Professor of Neurology & Neurological Sciences and Pediatrics at Stanford University; as well as Dr. Ed Fox, the Director of the Multiple Sclerosis Clinic of Central Texas and a Clinical Associate Professor at the University of Texas Dell Medical School, who chaired our Phase II study and was a Phase III investigator for their invaluable guidance. Both Dr. Steinman and Dr. Fox have graciously agreed to join us on this call today on a very short notice, I might add. So thank you both. I just want to thank all of the doctors and the research teams who participate in this important -- in these important trials, and most importantly, the patients and their families and the entire TG team who helped get us to this exciting moment. With that, I'm going to turn the call over to Dr. Steinman and then to Dr. Fox, to reflect on today's positive outcome. Dr. Steinman?

Thank you very much. This is a very important day for individuals with relapsing-remitting multiple sclerosis. The results of the top line data indicate that a very important barrier has been broken in the annual relapse rate. The rate was less than 1/10 of a relapse per year, and this has been a barrier that so far no other agent has proven in a Phase III trial. So this is very good news. The potency of the drug appears quite impressive passing that barrier. And the second thing is the ease of delivery. A 1-hour infusion every 6 months is going to be more than a convenience factor for individuals who have this disease to have ease of delivery, plus really impressive potency. So I'm thrilled that the results have turned out so well in these Phase III trials. From Dr. Fox' earlier experience leading the Phase II trial, one would have to look in retrospect and say it's not surprising because similar potency and, of course, ease of delivery was already observed in the Phase II trial. Ed, any comments from you?

Sure. Well, thank you for your comments, and I definitely want to echo what you've said about the annualized relapse rate being a threshold, which we've been hoping to reach for a number of years. I've been practicing for almost 30 years now, and I've been involved in clinical trials of each of the licensed products out for multiple sclerosis. So I was delighted to be part of the Phase II study as the lead investigator and have continued to see those patients in extension trials. So I've had patients subjects in clinical trials for several years now and then was enrolling in the Phase III ULTIMATE trials and having those patients in extension now. I was involved in the Phase III trials of ocrelizumab and ofatumumab as well. So I've been an early adopter and a big CD20 supporter, and I have a lot of experience in those trials and the clinical practice where I see well over 1,000 patients a year with multiple sclerosis. We have our own infusion suite, so I'm also familiar with the ins and outs of being able to schedule patients easily to match both the -- our institution's schedules and the patient's schedules to be able to properly administer the medications. So when I led the Phase II trial of ublituximab and the results came out, it was -- obviously, it was very efficacious. The annualized relapse rate of 0.07 and 93% of the patients being relapse-free at week 48 was striking data. And when presented at meetings, I had a number of people coming up to me, very impressed with the data. We observed a complete elimination or 100% reduction in the gadolinium-enhancing lesions, and that also got everybody's attention because that means that it was able to reduce the amount of inflammation being seen to an undetectable level. The idea of Phase II being a small trial, but looking at a range of dosage and infusion times, it became very clear that moving forward to the Phase III, we had the right protocol, which is a smaller dosage of 150 milligrams given over 4 hours initially, but then that could be followed by the 450-milligram dosage then given every 6 months. And I think that being able to be given 1 hour and seeing the tolerability of it, seeing the ease of which the infusion center was able to administer the medicine and get somebody out to the rest of their day was very memorable. I recall saying on a conference call a few years ago that the 100% reduction in gadolinium-enhancing lesions in the Phase II trial was really striking. And although it was a small trial, it led to a lot of hope that when we got to this point, what we're talking about today, that the Phase III top line results would be positive. And so I was extremely gratified to hear that it really recapitulated what the small trial showed. It did, in fact, reduce the annualized relapse rate to the extent that we would have expected based on Phase II. I felt like the anti-CD20 market has been steadily growing in my center, and certainly the national figures for that back it up. So now 1 in 3 patients with multiple sclerosis on therapies are on an anti-CD20 class medicine. I believe that number is going to grow over time. I don't see any way around that. With more choices, we're also going to have a larger market share. I don't think that TG has been shy about sharing that the price point may be a very important indicator as to which of the medicines will be used in the future. And the drug prices continuing to rise for MS treatments have definitely been a barrier for some of my patients. So now that I've been involved in ublituximab studies for a number of years, really since the beginning of the human trials, I want to congratulate everyone on today's positive top line result. It's been an exciting 24 hours for me personally, being involved in this. And I look forward to being able to share the information with my patients, my peers and to be able to continue discussing about it. So with that, I'll hand the call back to Mike and look forward to participating in the questions and answers.

Excellent. Thank you, Dr. Fox, and thank you, Dr. Steinman. So with that, we will open to Q&A. So I'll turn it over to the conference operator. We'll do some Q&A. After which, I'll come back and give some very short concluding remarks. But let's move on to the Q&A.

[Operator Instructions] Our first question is coming from Alethia Young of Cantor Fitzgerald.

Congrats on a very, very good data. It's a surprisingly good data. A couple of things. One, I guess, I know you don't have a lot of the information on the safety or infusion reactions, but maybe just remind us for Phase II, what you saw there and kind of -- I would assume that if there's been some sort of notable issue, we would know. So I guess then this is good news potentially. My second question is maybe for the physicians. And just thinking about there's subcu options, there's OCREVUS, and then you look at the data, like how do you think about potentially putting this into practice? Out of 10 patients, how many people would you consider those as an option for? And then maybe my third question is back to Mike. I mean, I guess, do you guys have any updated thoughts on pricing? I mean, I know I kind of thought maybe a 20% range or something like that might be a reasonable discount, but it's also very, very good data and almost from across all comparison, better data than some of your peers. So I guess just wanted to get your updated thoughts on that, too.

Sure. So why don't we -- go ahead, Larry. I was going to say you guys can talk about it.

Yes. This is Larry Steinman. I'll just make one point that one of the underlying reasons for the apparent ability to break this 0.1 relapse rate annually is the fact that this is a uniquely glycoengineered antibody that has some remarkable attributes that give it stronger ability to kill the CD20 cells and also allow one to infuse the antibody at a much faster rate. I'll turn it over -- we haven't announced yet the rate of infusion reactions, but I can turn it back to Dr. Fox who will share with you what we saw in the Phase II, which has been disclosed. Ed, any comments about the infusion rate?

Yes. I do. I think that the Phase II trial was well-designed to look at this question. And so one thing that you can ask is what percentage of the patient's discontinued treatment because of severe adverse reactions with the infusion. And we could say that with the -- what was used in the Phase III trial, which is 4 hours for the 150 milligrams initial dosage, followed a couple of weeks later by the 450 milligrams given over 1 hour, and then every subsequent dosing every 6 hours being given over just 1 hour, the infusion reactions were almost entirely mild. And so the idea of taking pre-medicines before this medication has already been seen with rituximab and ocrelizumab. And so what we found is that we're able to give these medications even orally. They didn't have to be given IV. So it didn't extend the infusion time period. So they were able to take adequate dosage of antihistamine and small dosage of steroids that blunted the infusion reactions to the point that the patients were, in my experience, always able to have a productive day for the rest of the day. And so the -- I think the clear indication from Phase II was that we had a tolerable and effective means of administering it over a short period of time, leaving the patient able to function the rest of the day. The Phase III trial, yes, we will have this information, but having enrolled a number of people in the Phase III trial, it was no different for me in Phase II than -- I mean, Phase III than it was in Phase II because it was exactly the same protocol we were using, and patients again tolerated it very well.

Thank you. So I think that covers questions 1 and 2, Alethia. And question 3 was on pricing. For the moment, no updated thinking. I mean, obviously, the efficacy data is quite strong. We'll get all of the data at some point over the next several months. But I think nevertheless, our underlying assumption here is that we're going to be strategically pricing to enhance access. And so even though this may be the best data of the class, I still think we want to make sure we strategically price it to make sure our patients have access.

Sorry. My rambling question, too, was also just kind of how do we think about the subcu like Novartis drug versus this one as an infusion?

Yes. Dr. Fox and Dr. Steinman, any thoughts about that?

It's Dr. Fox. I -- having to make this choice already, having 2 on the market, I can certainly see how 3 on the market is going to play out. It's going to be the same question as has happened with interferons. When they came out now over 20 years ago, we had multiple choices. And it came down to a sense of, not only efficacy, but also access. How easy was it to write that prescription and get it filled and get it delivered and so how it was met by managed care was a big part of this. But also, it was very important to have that conversation with the patient about the ease of use, tolerability. So the questions that occurred many, many years ago to look at a family of medicines and choose one really came down to that, conversations about convenience, access and the overall results of safety and tolerability. So the way I picture this coming down is that the market share is going to grow across the board. And as infusion suites have positive feedback from patients about the ease of use of this, that it will grow in utilization over time.

I think when I get into a room and talk to an individual with relapsing-remitting MS, the 2 questions that come up, what is the efficacy relative to the other choices I have? And what are the factors that may be more convenient? The third, of course, which may be at the head of the list, is will my insurance pay for it? So that's the basis of the decision. But I think given what we saw in Phase II and we at least see in the top line here, the efficacy question is clear. Though these were not head-to-head studies, it still has broken a very significant barrier in terms of lowering that dreaded relapse rates. And then I think that the issues of convenience and access are going to be really important. But for now, these are really thrilling results. And I think the top line results will be one of the main points of discussion when you're sitting there, one-to-one, face-to-face with the individual who suffers from the disease and often with their loved ones and family and going through this decision-making process, but it is terrific to have potentially, if this drug gets approved, 3 anti-CD20s on the market. And I think the factors I mentioned, the efficacy, the convenience and safety will all go into that decision.

Our next question is coming from Ed White of H.C. Wainwright.

Congratulations on the data. So Dr. Fox, you said that the price can be important to your patients. I just wanted to ask if you have had any reimbursement issues with the other 2 anti-CD20s, and is that a gating factor for your patients?

That is an important question and one that I'm rarely able to answer fully to the patients at the time of prescription. So it's -- the typical for us is that there is for those patients with conventional insurance is nongovernment-based, that there is copay assistance programs that help offset the out-of-pocket expenses for these medications. I have had barriers thrown up repeatedly on access to medications based on step edits where they require, especially for new starts, that the patients have failed one or more therapeutics that's on their preferred list. And so it's extremely important to me that even early on after launch that aggressive negotiations have taken place to allow me to prescribe the medicine when I would want to prescribe the medicine, whether it be first line or as a switch. And so the answer to your question, have I had hurdles? Yes, I have had hurdles of access based on step edits. And yes, I've had some rare difficulties when it's come to out-of-pocket expenses for patients with deductibles that have not been met by the company. But it -- usually, results in delays but not complete prevention of being able to use the product of choice.

Great. And maybe a question for Mike. Just going down this path on reimbursement, how has the efforts of the company been so far? Have you gotten any feedback from payers yet? And then maybe you can talk a bit about commercialization strategy and timing for your marketing efforts, both here and outside the U.S.

Yes. Thanks, Ed. So in terms of conversations with the payers, we're early on in that process. We're doing some payer surveying as we speak. So that's underway. In terms of the commercial effort, we've built a really robust commercial platform for the oncology side. Many of those pieces will be usable to oversee the MS component. I think we're going to start aggressively to put together some of the pieces. I think this was kind of a triggering moment for us to get aggressive in terms of starting to hire folks, specifically for the MS teams. But like I said, the overall platform is quite robust and covers MS as well. So our market access teams, our commercial operations teams are all dual-functioning and in place. So I think we're going to start to build out some of the medical -- and we also have a -- we've always had a small medical affairs department on the MS side. So that will continue and to grow. And then at some point, we'll obviously start building the sales effort, but that's a long way off. That's something that will occur -- will be finalized probably in the last 3 months leading into launch.

Our next question is coming from Josh Schimmer of Evercore ISI.

Maybe first for Dr. Steinman and Fox. What else would you like to see from these -- from the trials to support your confidence in the profile of ublituximab? And for patients who are in your practice that may already be on a CD20 antibody, how are you thinking of incorporating ublituximab initially and over time? And then after that, a quick question for Mike. You've shown a benefit in one autoimmune disease. Now with ublituximab, you've got umbra. You've got a BTK inhibitor. All of which, in theory, you could explore in MS or other autoimmune diseases. So where do you think you're going to go from here in the months and years ahead?

Thanks, Josh.

Okay.

Go ahead. Go ahead. Go ahead, Ed.

Yes. So the protocol certainly has defined endpoints, not just the primary, but on down the list. And these are the established outcomes that we're looking for in clinical trials and have certainly been looked at in other trials. So we'll be looking at those numbers. What I expect to see is, again, robust benefit in regard to MRI. And the disability data is certainly going to be important as well for me to look at. I think that as we go down that list of outcomes, we're going to be looking is the outcomes now that we pay much closer attention to than we used to, like no evidence of disease activity, that percent of patients without relapses, confirmed disability progression or MRI changes. So I think that number of all of those, if I had to pick one that I'd love to know today, but I know I have to wait for it, that would be one. In terms of what I'm going to do with my -- and I have hundreds of patients now who are on anti-CD20 therapy already. And so what am I going to do with those? Am I going to offer to switch to this? Well, for patients who are on injectable medicine with self-injections, I think that's going to have to do with the tolerability of the medication. And so ofatumumab is -- certainly, I think the people that are the most excited about that one are the ones that have very poor access to infusion suites where they live, living in more remote areas, something like that, or transportation difficulties. And so I think that's still going to remain. But for those patients who are already on every 6-month infusions, then it may really have to do with, again, access, whether I can make that switch, but also whether the patient will be desirous of a shorter infusion time. I will tell every single one of my patients who are on ocrelizumab about this because I think it's important for them to always know what their options are. And so I'll be interested in seeing what the response back to me is. I think that there maybe a percentage you want to switch at that point. And I won't see any hurdles to switching from a medical standpoint, meaning that I don't foresee any issues with that switch from a safety or efficacy roadblock.

Yes, I would agree on that. I don't see any medical issues. I think we'll have to -- if there is a study looking at switches, we'll have to look at the infusion reactions to see if the differences between the 2 products lead to some immunogenicity, but I don't expect to see that. And going back to the further data available, many of the things that we expect to see will be what effect we have on MRI imaging. And then most importantly, how many people really look like they have this category of no evidence of disease activity at all. And again, the Phase II trial was exceptionally encouraging, but we'll have to wait to see all the data and the analysis of that data before making any further comments.

Thank you. And then, Josh, you had asked me about potential in other autoimmune diseases and also the potential of the remainder of the portfolio. So the short answer is, yes, we are definitely interested in exploring other autoimmune diseases. I think in my very first slide deck I put together in 2012, I mentioned RA, lupus as areas of potential utilization for ublituximab. There's kidney diseases, autoimmune kidney diseases. There's myasthenia gravis. So yes, I think we're going to do a full evaluation of what the next best opportunities for us are in autoimmune diseases. And I can assure you from the very first day that we brought in our PI3K delta, the idea of combining CD20 and PI3K delta in autoimmune diseases was in a slide deck way back when. Still on my to-do list. And now that we have the BTK in-house as well, I think we have some interesting opportunities to bring our combination approach into autoimmune diseases. So stay tuned. Still early in our thinking, even though it's been thought about for years, but I think we're going to look to get into those areas as soon as we can.

Another place that I would push the company to explore is primary progressive disease with this degree of efficacy and with the really interesting bioengineering of this compound. The more you can suppress the CD20 B-cells before they get into the brain, the better the potential outcome might be in this primary progressive arena as well.

Yes, that's a great point. And we are definitely trying to figure out our strategy there as well. And I agree with you 100%.

Our next question is coming from Chris Howerton of Jefferies.

I will also offer my congratulations. I think I could hear your smile when you're reading your script, Mike. So...

Thank you, Chris. Appreciate it.

Sure. Yes. So then maybe just a couple of questions for me, I think. If there's any details that you provided with respect to the SPA, that would be helpful to just remind us. And then what are kind of the steps to get a BLA submission in place? And then for the physicians, Dr. Steinman and Dr. Fox, one of the things I completely agree with you is that the annualized relapse rate below 10% is obviously extremely important and impressive. But as you're interpreting that result, how might the performance of the control arm affect that interpretation and your thinking of the impressiveness of those data?

Well, as far as comparison to the control arm, it's the -- the control arm was similar to what was used in the ofatumumab study, and it looks like it's in line, but the actual annualized relapse rate decrease is a figure that stands on its own. In that group, the rate was less than 0.1 annualized. And again, like the sound barrier was when Chuck Yeager broke it, that's a big deal. And -- well, he just passed away couple of days ago.

I saw that.

We all know Chuck Yeager. But this was a similar type of barrier to speak metaphorically, and it appears from the top line that ublituximab crushed it. So that's good news.

Yes. We certainly agree with that. So I will -- I think that answers your question, Chris, on that side. I'll discuss the -- you asked about the SPA and the steps to BLA. So the SPA, obviously, as you are well aware, is a assessment that the FDA does. And you agree on the protocol, the design, the endpoints and the -- and all the pieces actually of the protocol. So we feel confident that, that gives us the comfort that what we've done in our clinical trials should support the BLA submission, obviously, assuming they agree with our assessment of the data, but the study design and endpoints should not be an issue. And then in terms of steps to the BLA, we've got to, I think, finish, obviously, getting all the data together so we can do the full analysis, which will lead us to be able to prepare a clinical study report. And I think that all those things take time. The nice part about this particular BLA submission is that our CMC section will be soon submitted for CLL. So that will -- we'll get a head start there. So it's really should be just getting the clinical components together and the nonclinical, of course, as well. So I don't want to understate that portion as well. But yes, I think it's just time to get these things pulled together. There's obviously pieces that are still coming together because we just finished the clinical program. We're going to hope to have, I assume, a conversation with the FDA to get agreement on what would be included in the BLA in terms of studies. Assuming, again, that the agreement is where we hope it'll be, we should have no trouble in meeting our target for mid-2020. Of course, you never know what you're going to get.

'21, right?

'21. Sorry. Yes, '20 -- yes, I'd love to be middle of 2020, that would be great. Right. That would be fantastic. Yes, so middle of 2021. So we'll see. We've got some discussions coming up, and the team has a lot of work to do to put the package together, but it should all fit together nicely.

Our next question is coming from Eric Joseph of JPMorgan.

Let me add my congrats on the data. Just a follow-up on Dr. Fox' earlier comments about some patients -- the hurdle in reimbursement in some patients having to proceed through step edits. Can you sort of just elaborate on what medications patients are being asked to step through? And maybe for Mike, how likely it is that these edits could be minimized or alleviated with any discount potentially to OCREVUS? And looking to potential commercialization in 2022, can you just remind us where you are in terms of product supply and manufacturing, whether there's any scale up in manufacturing to proceed through on the way to commercialization?

All right. I'll follow through on my comments earlier. The step edits, they will have a list of medicines. Sometimes, it's very difficult to get that list from them, but it almost always includes the generics for glatiramer acetate may now contain the generics for dimethyl fumarate, the oral medicine. So they -- if they have a 2-step edit, they don't tell you, well, start with this one and then go to that one. They don't give you an algorithm that you're supposed to go through. They just give you a list. So the way that we can find out about this is that they send back prior authorization questionnaire, and they say, has the patient been on this medicine? Then I know, okay, well, that's what they're asking this for. And then I have to have a peer-to-peer where I talked to a medical director and say, "Well, this is why I'm not going to use those medicines that have not been used. This is why I feel like this medicine is the appropriate first-line medication." And I almost always win that battle. They'll hear me out on it and say, "Yes, I understand you have a medical rationale for what you're trying to do." So I anticipate over time there to be increasing list of medications based on price points. And so my hope, of course, is that to managed care, this is seen as a very good addition to them as well in terms of opportunity to be able to use the medication. I think that it is unlikely in the next 5 years that we're going to, in the MS community, come up with our own algorithm where we say, this is how you start with a newly diagnosed patient. And the reason that we can't do that, whereas oncologists have done it routinely, is because the variability and severity of the disease is so great. There really is not a one size fits all. We don't have staging for MS that allows us to have a clean algorithm for treatment protocols.

Great. Thank you. So Eric, you had asked about commercial supply and scale up. Yes, so the good news is that, again, because of our CLL application and timing, we are, on the MS side, well prepared. We've -- we're fully scaled up in terms of vessel size, or everything is set there. We're with the largest and most established antibody manufacturer in the world. And so given the kinds of quantities that we're preparing for, for CLL, the quantities in MS are not nearly the amount. And so we've got plenty of supply capacities that we've built into our CMC program. So I think we're feeling quite good about that.

Our next question is coming from Matt Kaplan of Ladenburg.

And let me add my congratulations. I guess question is for Dr. Fox. I guess, you mentioned that you run an infusion center and -- just can you give us a sense in terms of how products like ublituximab with this profile in terms of shorter infusion times would impact your management or of -- and running of that infusion center for MS patients?

Sure. The way the ublituximab has given over 1 hour and then 1 hour of observation time afterwards is really the same time frame as TYSABRI. So natalizumab, we've given that infusion suite initially part of the clinical trials and then on label for well over 15 years now, and we find that very easy to schedule. So easily, you can have somebody come in for a morning appointment, then somebody may be coming in for a much faster infusion where there are other neurologic conditions. I'm in a general neurology practice. And so we have specialists -- subspecialists in neurology giving other products as well, and some of them are notoriously long to give, many hours of infusion, and others are very, very quick. So the 1-hour infusion with 1-hour wait time means, at the minimum, you can have 2 people sitting in that chair a day. And really, logistically, you can do 3. And so the throughput of the patients and the infusion suite is much more efficient this way, and it -- you can get by with fewer chairs. And that makes a big difference when you're talking about institutions who have space limitations, and that's usually the biggest problem. It's not actually staffing it with infusion nurse, it's actually having the square footage. And now with COVID, you can imagine having to do social distancing, we've had to take over most of our waiting room for the infusion suite by spreading the chairs out. So we've gotten this kind of crash course in how to manage an infusion suite under limited circumstances. I point out that there are investigational products now for Alzheimer's disease, for Parkinson's and a number of other neurologic conditions that are also biologics that are -- could be administered in infusion suites around the country. And so there's going to be a crowding for space, every academic and nonacademic institution. So any way you can get more of your patients in, in a day and get them their products, the better. So I'm hoping that sort of tells you how things are going to change over the next year or 2.

That's very helpful. And anything from the -- from a patient's perspective, too, in terms of the infusion time and how that kind of impacts their daily life?

Yes, I think that there are a lot of professions where you can just imagine that taking a 2-hour break from your workday is going to be feasible. If you're the first one in the morning or the last thing -- last one in the afternoon, for that chair, then you're going to miss much less work or you're going to be able to work around with meetings at work and everything else. So I think the patients, for sure, like the idea of having an infusion where they don't have to bring a meal with them. When you have 4-hour infusion times with half an hour before and an hour after for ocrelizumab, they were actually having to bring food. They definitely had to bring things to occupy themselves. Over a 2-hour period, no, they don't really have to plan for their day to be sitting in the chair.

Our next question is coming from Mayank Mamtani of B. Riley Securities.

Congrats on crushing it with the data in Dr. Steinman's words. And Mike, I'm glad to hear your thinking on the broader autoimmune diseases. Just a quick clarification question, if I may, to Mike. On primary efficacy analysis, was there any impact of COVID on the relevant ITT patient sample input relative to what you had originally projected on sample side, Mike?

No. No impact.

Okay. Great. And then my follow-up, on the -- to Dr. Steinman or Dr. Fox, the longer-term exposure of anti-CD20 is, how should we think about sustained B-cell depletion over time? And I believe, Dr. Fox, you said there was this small cohort of Phase II subjects that might have been followed up. I don't know if they were still actively on the drug. But I'm just curious, as we see data from the 2 more advanced anti-CD20s longer term, what's your thought process on both the efficacy and safety profile?

The patients who are in the Phase II trial have all been given the opportunity to be in the extension. And certainly, in my center, 100% of them took us up on the offer. So they've been on continuous medication and the expectation is that they will still be on that medication at the time of launch. So the extension trials are very important to us to show long-term efficacy and safety data. It's of prime importance to the sponsors and importance to the patients that they have continued ongoing treatment. So I think that from the standpoint of patients, having been on it for years, the reason that's very important to me is that when I am telling -- talking to a patient about choice of medication, it's really advantageous for me to be, personally, to be able to say, I've had patients who have been on this for X number of years because it gives the patient a sense that, yes, this is not -- although a new product to the market, this is not new in terms of experience. So I think that, that's better than saying, well, this has been used in the oncology world for a number of years. I want them to know it's been used in the MS world. So by saying that, I take away any disadvantage that they might perceive as being, well, I think I'd rather be on the medication that's been on the market the longest because I'm sure we know the most about that one. So I think that's the best answer I can give you at this point in time.

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

Great. Thank you. So I'll keep this very brief. First, I just want to conclude by once again thanking Dr. Fox and Dr. Steinman for joining us this morning and for their continued supporting guidance with our MS program. I also want to thank the -- our entire ULTIMATE I and II steering committee who have been really instrumental as well in guiding and supporting our program. With that, let me just finally thank all of you, our loyal shareholders, who continue to support our bold effort to bring important medicines to patients with B-cell diseases. Have a great day.

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