Earnings Call: Q1 2021

May 10, 2021

Greetings, and welcome to TG Therapeutics Q1 twenty twenty one Earnings Conference Call and Business Update. As a reminder, this conference is being recorded. I would now like to turn the conference over to Gina Bosco, Senior VP of Corporate Communications. Please proceed. Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter twenty twenty one financial results and provide a business update are Michael Weiss, our Executive 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 as well as an update on our current pivotal programs and key goals for 2021. 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 and A session. Before we begin, I would 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. 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 filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10 Q. In addition, any forward looking statements made on this call represent our views only as of today and 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 conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next thirty days. All participants on this call will be on a listen only mode. Now I'd like to turn the call over to Mike Weiss, our CEO. Thank you, Jenna, and thanks to everyone for joining us this morning. With the recent accelerated approval of YUCONIC for the treatment of relapsed or refractory marginal zone lymphoma and follicular lymphoma, TG has transitioned into a fully integrated commercial organization. Are extremely pleased to now have Yukonic, the first and only dual inhibitor of p I three k delta and c k one epsilon available to patients. We see the approval of Yukonic as the first step in our broader mission of developing novel treatment for patients with B cell diseases. With successful phase three studies in chronic lymphocytic leukemia, referred to CLL, and multiple sclerosis, MS, already completed and reported, we see the potential to positively impact a significantly larger patient on the horizon. Beyond that, our pipeline has the potential to deliver novel combinations building off a foundation of UCONIC and upletuximab, our U2 combination, that can further enhance outcomes for patients with B cell diseases. Before I hand over the call to our chief commercialization officer, Adam Waldman, to discuss the Econic launch and preparations for the potential CLL and MS launches, I wanted to review some of our recent accomplishments as well as the current status of our ongoing programs. First and foremost, as I mentioned at the outset of these prepared remarks, in February, the FDA granted accelerated approval of Yukonig for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti c d twenty based regimen and for adult patients with a relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. This approval was primarily based on the results from the YUCONIC monotherapy cohorts of the UNITY NHL phase two b trial. And the approval came just shortly after the final results from this trial were presented at the American Society of Hematology Annual Conference, we refer to that as ASH, in December 2020. Also of note, within a month of approval, these results were also published in the Journal of Clinical Oncology. The commercial team has been hard at work educating potential prescribers about Yukonig and building a strong foundation, which we we believe will continue to translate into adoption of Vuconic and position us well for the planned CLL launch potentially later this year or early next. On that note, as as most of you know, we presented positive results from the UNITY CLL phase two trial at the ASH annual meeting in December. And more recently, at the March, we announced the completion of a rolling submission of a biologics license application, referred to as a BLA, to the US FDA requesting approval of lupatuximab, our investigational glycoengineered anti c d 20 monoclonal antibody in combination with Yukonig. The combination, as many of you know, we refer to as U2, as a treatment for patients with chronic lymphocytic leukemia. This BLA submission was based primarily on the results of the UNITY CLL trial, which which was conducted under special protocol assessment. And as a reminder, the FDA previously granted fast track designation to the u two combination for the treatment of adult patients with chronic lymphocytic leukemia and orphan drug designation for U for the u two combination for the treatment of CLL. The next step is we expect to hear from the FDA later this month on whether they have accepted the submission for filing. Approximately a hundred and eighty five thousand Americans living with CLL and approximately forty thousand patients seeking treatment annually, CLL remains an incurable disease and represents a large patient population where we believe you too will provide a needed treatment option for these patients. Now I'd like to turn to our MS program where our BLA submission is slated for the third quarter of this year. That BLA will be supported by the positive results from our ULTIPATE one and two Phase three trials evaluating ublituximab in relapsing forms of MS, which were presented during the AAN conference last month. Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate, which we we call ARR, annualized relapse rate, over a ninety six week period with a p value of less than point zero zero five in both the trials. That's compared to teriflutamide. And the ilbetuximab treatment, resulted in ARR of point zero seven six in ULTIPATE one and point zero nine one in ULTIPATE two. For those who were on the call with the experts, which I'll talk about momentarily, they were very excited to see that those those ARR numbers were below point one, which has never occurred, before in a phase three trial. So really excited about those results. We also hit key secondary MRI endpoints, including, statistically significant reductions in both t one gad enhancing lesions as well as t two lesions. Lupatuximab also reduced disability progression and increased the rate of disability improvement as compared to teriflutamide. However, the former was not statistically significant. In addition to the presentation at ANN, we hosted a call with leading neurologists to review this data. A replay of that call is available on our website, and I do encourage folks who are interested in TG, to have a listen to to that call. The doctors on the call were very enthusiastic about the profile of upletuximab and its potential in the treatment of MS. For our part, we're extremely pleased with the results from the ultimate one and two trials and believe these data showcase the potential of ublituximab to provide a highly efficacious treatment option with a generally well tolerated safety profile. If approved, ublituximab will be the only CD twenty offered in a convenient one hour infusion every six months, of course, following the first infusion, which treating physicians have shared is an important benefit for them and their patients. As a reminder, this trial was also conducted under special protocol assessment with the FDA. And as noted earlier, we are targeting a BLA submission for ublituximab to treat patients with relapsing forms of multiple sclerosis in the third quarter of this year. The last topic I wanna cover before turning the call over to Adam is our U2 plus venetoclax program and our U2 plus seventeen o one program. As a reminder, seventeen o one is our internal BTK inhibitor. We view both of these programs to be an important part of the growth strategy for u two and CLL. For the u two plus venetoclax program, we have the phase one study led by doctor Paul Barr, professor of medicine and director of the clinical trials office for the Wilmette Cancer Center in Rochester, New York. Preliminary results from the first twenty seven patients in this study to complete 12 cycles of fixed duration therapy were presented at ASH this past December. In those patients, there was a hundred percent overall response rate, and greater than seventy five percent of those patients achieved undetectable minimal residual disease in the bone marrow. To my knowledge, that is the best reported rate of undetectable minimal residual disease in the bone marrow to date in patients with a relapsed refractory CLL. Later this year, we should have almost two times as many patients to report, through 12 cycles of treatment. So hopefully, that will be something we were able to present at ASH this year. Now that phase one set the foundation for our ULTRA V phase two slash three trial, which is evaluating the combination of u two plus venetoclax in patients with both treatment naive CLL as well as relapsed refractory CLL. The phase two portion of the Ultra V trial completed enrollment with approximately a 65 patients being enrolled in just sixteen months. The phase three portion is now open to enrollment and is a multicenter randomized trial comparing u two plus venetoclax to an active control arm of u two. This trial is being led by doctor Richard Furman, who is the director of CLL Research Center at the Weill Cornell at Weill Cornell Medicine. We are excited about this combination and believe it can potentially offer patients a very active treatment that is of limited duration. Finally, I'll mention that our BTK inhibitor t g seventeen o one continues to impress us. We reported preliminary data at ASH and will provide another update in the coming weeks at ASCO. Our goal is to explore the potential combination of Yukonic NU2 with seventeen o one to offer the benefits of the triple inhibition of BTK, PI three k, and CK one epsilon, which would be the first, of its kind, and putting them together, but also dialing down the known toxicities of each of those classes. Again, this would be a very novel first in class product. As you can see, significant progress has been made across all of our pivotal programs, setting us up for an exciting remainder of 2021 and hopefully even more impactful 2022 with the potential of expanding our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our chief commercialization officer, Adam Walman, to share some highlights from our early commercialization efforts of YUCONIC. Great. Thanks, Mike. And, I am I am very excited to provide a commercial update on the YUCONIC launch as we report revenues for the first time. With this launch, we are not only bringing an important new option to patients, but we are setting the foundation for multiple potential future approvals, including the combination of YUCONIC and ublituximab known as U2 in CLL as our next major milestone. While it is still early, we are pleased with our initial launch execution and feel we have made significant progress against our initial launch objectives. These were to build awareness of YUCONIC's differentiated profile, drive adoption with our targeted customers, ensure a positive first experience and as I mentioned, the foundation for TGN lymphoma as we plan for an anticipated launch of U2 in CLL. In our first partial quarter, we achieved $800,000 of net sales of YUCONIC. YUCONIC is the first and only inhibitor of PI3K delta and CK1 epsilon is a unique treatment option for patients with relapsed follicular or marginal zone lymphoma. Consistently, we have received specific and positive feedback about its clinical profile from our customers. Through market research, advisory boards and our field team engagements, we have confirmed that Yukonak is different is seen as a differentiated product. We've consistently heard that the proven efficacy across Marginal Zone and Follicular, its unique MOA, tolerable safety profile, low rates of discontinuations and a lack of a black box warning are important differentiators with healthcare providers and payers. We believe that these factors help establish YUCONIC in a class of its own. We recognize that second line marginal zone and fourth line plus follicular lymphoma, our label indications, represent relatively small patient populations. Therefore, our strategy out of the gate has been to target the higher volume prescribers at academic centers and large community practices. Further reinforcing our strategy, we estimate that there is a roughly 85 overlap in the prescriber base between indolent non Hodgkin lymphoma and CLL. So we also view the lymphoma approval as a valuable opportunity to introduce ourselves to the treating community and build the credibility and trust that will be critical to the CLL launch. So far, UConnex initial uptake indicates that this strategy was well informed with the majority of our initial use coming from targeted customers. Uptake has been roughly fifty-fifty between the academic and community settings with many of our early adopters having prior clinical trial experience with Yukonik. While our customer facing teams have been resourceful and strategic in our approach to engage and educate our customers, COVID restrictions have posed some challenges. Physicians report being Zoom fatigued after a year after over a year of virtual engagement. However, the good news is that we are seeing live engagements continue to increase and believe COVID restrictions will continue to dissipate over the next several quarters, which should accelerate customer engagement going forward. Our latest market research shows that over eighty percent of our target customers are aware of the VUCONIC approval and approximately ninety percent of the physicians we surveyed that have met with a TG representative either live or virtually view the efficacy and safety profile of YUCONIC as favorable versus available options. We believe this to be very positive and demonstrates the effectiveness of our early launch efforts. On the patient access front we worked hard to provide robust service offerings immediately upon approval through our TG patient support program, which we received very positive feedback from patients and healthcare providers to date. We are committed to making sure that each and every health care provider and patient has a positive experience with TG and YUCONIC. In addition, we've been successful securing coverage for YUCONIC. We're happy to share that we've been able to rapidly achieve coverage of YUCONIC with large health plans such as Cigna, Aetna, Anthem, and Kaiser. ECONIC is now covered for eighty five percent to ninety percent of Medicare and commercial lives. Additionally, ECONIC has been added to The US Oncology ClearView pathways for follicular lymphoma consistent with our label. YUCONIC has also been added to the NCCN guidelines to a 2A option for patients with fourth line follicular, fourth line plus follicular, and second line plus marginal zone lymphoma. Together with the payer coverage, these inclusions further enable patient access at institutions and practices. Overall, we are pleased with the launch progress to date, and we are positioning ourselves for success as we prepare to potentially launch U2 in CLL. We have some of the most talented commercial people in the industry and TG at TG. And despite launching during a global I believe we have made great progress with the Yukonic launch to date. With that, I'll turn it over to Sean Powell. Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning, we reported our detailed first quarter twenty twenty one financial results, which can be viewed on our website at www.tgtherapeutics.com. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash position. We ended the first quarter with approximately $525,000,000 of cash, which we believe will be sufficient to take us into 2023. As Adam noted earlier, following the FDA's accelerated approval of UCONIC on February 5, we were pleased to report $800,000 of UCONIC net revenue in the first quarter. Our net loss for the first quarter of twenty twenty one, excluding noncash items, was approximately $74,000,000 compared to approximately $40,000,000 in the first quarter of twenty twenty. The increase we've seen in net loss as compared to the first quarter of twenty twenty is primarily related to increased selling, general and administrative expenses associated with the preparations for and now execution of the commercial commercialization and launch of YUCONIC, which occurred in the first quarter of twenty twenty one. Additionally, during the first quarter of twenty one, we saw an increase in r and d expenses over the 2020 period, which was primarily driven by onetime licensing milestone payments of approximately $14,000,000 consisting in large part of a $12,000,000 due on approval of Econic. Our GAAP net loss for the first quarter of twenty twenty one, inclusive of noncash items, was $90,600,000 or $0.69 per share compared to a net loss of $51,100,000 or $0.48 per share during the comparable quarter in 2020. With that, I will now turn the call back over to the conference operator to begin the Q and A. Thank you. At this time, we will conduct a question and answer session. Session. Our first question comes from Alethia Young with Cantor Fitzgerald. Please proceed. Congrats on the progress with the launch. A couple. One, can you talk maybe a little bit about the breakout roughly in the kind of between MVVL and follicular that you're seeing? I know it's a small number, but I just wanted to kind of get a feel for which way the tide was cutting on that. And then, you know, for a second question, I was I was curious, just on, obviously, kind of early feedback around some of the the GI talks that I've been seeing in the past and what people have what initially physicians have been seeing and patients have been seeing there. And then my third question is just, was there any inventory stocking? Thanks. Adam, you wanna if you I don't know if you have any information yet on breakout between follicular and marginal zone and stocking question. Sure. Sure. Sure. Yeah. So so from what we've seen so far, and it's early, but what we've seen demand for both marginal zone and follicular, it's hard to to, it's hard to estimate exactly the breakdown, but we've seen, usage in both. So we're we were very happy to see, that. As far as the stocking question, given that there many practices only see a few follicular margins on patients per year, We anticipate pharmacy ordering generally to be on an as needed basis. So we have placed some inventory and and, with distributors to fulfill pharmacy orders consistent with industry norms, for a product like Muconic. And then I think the third question was GI tox. Yeah. That one. Yeah. So far so good. It's it's obviously still early, but the reaction to the profile, has been, very good. Obviously, we've been educating customers to stay on top of it and be ready for it, know know how to treat it if if they see it. But so far, so good. Great. Thank you. Our next question comes from Chris Harrison with Jefferies. Progress, obviously, commercial and and r and d, and and thanks for taking the questions. Thanks, Justin. Let's yeah. Absolutely. And so let let's see. I guess, first off, for the I just don't recall what the status was of and maybe some information around the designs for the confirmatory studies for follicular and marginal zone. Just maybe some updates or some color on on that side of the story. And then moving forward towards the end of the year, so I just maybe wanted to get a a little bit of a level set in terms of what kind of information we can get from the pipeline. I know that you said seventeen o '1 at ASCO, but just maybe, what are kind of the the key highlights and data expectations for ASH at the end of this year, if you might? Thanks. Sure. So on the, the confirmatory trial, don't wanna say too much yet. We have noted in the as part of the approval, we had a basic design discussed with the FDA, but we do need to finalize that. So I I think it's it's gonna be in and around what what other companies have have announced previously from their their confirmatory trials, and our hope is to get it up and running before year end. And we'll give a lot more detail at the time. But, again, the there's a relatively standard trial design that that's out there, that other companies, including Bayer, Focalpanolisib, and Juvelisib have have announced. And I think we'll be sort of closer in line to those kinds of studies. In terms of pipeline updates this year, so as I noted, we'll have some more information on 17 o one at ASCO. And, you know, I was I've I've been relatively vocal that I was pretty pleased with the results that we saw at ASH. I've encouraged folks to to take those results and and line them up with other BTKs, both covalent and noncovalent, and and and see for themselves, you know, if they're seeing the same thing I'm seeing. Like I said, we'll have some more of that information available at ASCO, and I imagine we'll have even more available at at ASH later this year. For ASH as well, as I noted in my prepared remarks, we we do hope to have twice as many patients or approximately twice as many patients, so nearly 50 ish patients available for that twelve month endpoint for for the u two plus venetoclax phase one trial. The so so that is what I'd say is the the goal for for u two plus venetoclax would be that dataset, the phase one follow-up on I I assume it's a follow-up on all patients at that point or close to all patients. And then for the Ultra V phase two portion, you know, as we noted, we we finished the enrollment in early, this year, earlier this year. So we don't have all a 65 patients enrolled through twelve months at that time. So the question is going to be whether, any of it gets presented in a partial format or, it's held to a full presentation. That would be primarily an investigator driven decision. For me personally, I guess it doesn't matter all that much. We're gonna have plenty of data from the phase one, and and then, you know, the phase two will come when it can. If we can get some out from Ultra V at at the at the ASH conference, we'll do it. If not, that'll be a a pretty fulsome dataset available for, ASCO EHA approach in in the June time frame of of next year. So that's that's the Ultra V. And then, eighteen o one, we've got our fingers crossed. We'd like to present some early data at at ASH this year. So 18 o one is our c d 47, c d 19 bispecific antibody. The we've just opened up the the trial here in The US. We were because we started the study ex US, we we weren't able to move as fast as we we would like. I think things are gonna start to accelerate, but we're we're already in in May. Having said that, the goal is to get, some information out on that compound, by year end. And I think that's probably what we have to offer for the moment. There may be, other, cuts of data that we look at and we present, but I'd say those are probably the the major updates for for later this year. Okay. Alright. Well, that's certainly a lot going on. And then, you know, I mean, maybe just to remind us, the the phase two portion of the Ultra V study, that does have the possibility to have a registrational, implication. Is that right? Yeah. It it is possible. You know, it's something that's probably gonna be somewhat challenging as a single arm with multiple drugs. But, you know, once we have all the data put together, we'll we'll definitely have a conversation with the FDA and and and see what their appetite is, for an accelerated approval. We know that accelerated approvals in CLL are challenging these days for them, but we do feel like the data will be, quite encouraging. So, we'll take our shot. No guarantees, for sure no guarantees, but we'll take our shot. If not, again, we think it's a very robust data set that should provide a potential update to the NCCN guidelines. Our phase three will be well into the enrollment phase and so that will be ongoing. Both drugs are approved and obviously we would not be marketing at all to to a YouTube postmenopausal. But physicians are capable of of making their own decisions. And, again, both drugs would be approved in, in the indications, that someone might be wanna use them. So, again, you know, we'll we'll at best have something that's useful for, compendia listing. I mean, not best. Best case scenario would be best case scenario would be approval. But, this the second option would be, it'll be useful for companion listing, and and that's pretty good too. And then the like I said, the registration trial is is ongoing. Yep. Okay. Alright. Very good. Well, thanks again, Mike. Appreciate it. Thanks, Chris. Our next question comes from Josh Schimmer with Evercore. Please proceed. Thanks for taking questions, a few primarily housekeeping questions. For SG and A, the noncash comp cadence, can you help us understand? It looks like it's second half loaded, at least over the last eighteen months. Is that by design? Or is that coincidence? And then for the R and D milestones that you had recorded in the first quarter, are there any additional ones that you would expect to be booking in 2021? And then last question, if you can update us on your plans for ex US commercialization for territories for which you have the rights for, Ubli and Umbra. Thanks. Great. Thanks, Josh. Sean, do you wanna hit on the SG and A and the r and d milestones? And I'll I'll talk about the ex US. Sure. I think the SG and A, noncash comp being backloaded the last year or so, was certainly not by design. I think it was a function of, the the commercial build, certainly last year prepping for the Econic launch. I think it'll probably be a bit more, level in, in '21. Although as we do, continue to ramp for a potential CLL launch, you might see a slight trend upward again in the in the second half. In terms of r and d milestones, left for, potentially '21, there is a milestone due to LFP on the approval of ublituximab. So should that should we be fortunate enough for that to come in in '21, that would be a, '21 milestone. Okay. What's the approximate amount of that milestone, Sean? Low, double digits. Excellent. Okay. And then in terms of ex US, Josh, we are we're we're still working working out the details there. Adam and his team have been doing kind of a full court press evaluation of, what's the the best approach there. You know, we've given ourselves a little bit of time to make those applications after the approvals, for u two and for Oobli and MS. So we're gonna after the approvals here in The US, we're working toward the approvals here, and then we'll work toward the approvals abroad. So we have a little bit of time to to make that call, but I I would say, and Adam can confirm that this team is leaning toward, keeping it internal, and launching ourselves at least in the major European markets. And then I think, opportunistically, we'd look for partnerships in places like Japan or China to see if there's some some value to be extracted. But, but probably in the major European markets, lean today is toward, doing it ourselves. And what are the timelines for for registration in Europe? So I think the filings will be made probably six to twelve months after, we have the approvals here in The U. S. Thanks very much. Thanks, Josh. Our next question comes from Eric Joseph with JPMorgan. Please proceed. Hi. Good morning. Thanks for taking the questions. A couple. First on the chronic commercial. Do you have a sense of repeat prescribing patterns so far? And what are you what are you anticipating in terms of growth in new patient adds and duration of therapy over the course of 2021? And then just following up on the question about the registration potential of OCAV, I I yeah. How should we be thinking about a a cool time line in the phase three trial if the phase two in and of itself isn't isn't strong enough for approval? And does the phase three trial represent at all a headwind to u two commercial, assuming label expansion at the turn of the year? Thanks. Sure. Thanks, Eric, for those questions. Adam, you wanna tackle the the first two, the the kind of commercial and the users? Yeah. Go ahead. Yeah. Yeah. Certainly. You you know, Eric, it it is still early, but the good news is we we have seen refills, and and we've also seen physicians prescribing for more than one patient. So we think this is a really positive, indicator. But it is it is still early. As far as the duration goes, we'll see. Obviously, we're doing everything we can to educate, physicians and healthcare providers on managing patients and keeping them on therapy. We think that is key, to our future success. Great. Thanks, Adam. And in terms of the accrual timelines for ULTRA V Phase III, we think there's probably going be a twelve to eighteen month accrual period, and that'll be followed by a similar, probably, twelve to eighteen months of of follow-up. Now there's there's two groups here that we're we're so we have two separate, basically, separate studies almost built into the one study. So we have a cohort for relapsedrefractory, and we have a cohort for frontline. So they could enroll at different paces. And, certainly, the follow-up on the relapsedrefractory side will be shorter. So it's altogether possible that and they're separately powered so the studies can be completed independently. The study can be completed in two parts. So we think there's probably a greater chance that the relapsed refractory would go to the FDA more quickly, potentially in sort of the, let's say, twenty four to thirty six month time frame, and the frontline probably a little bit longer. I don't think there's there's really too much in terms of headwinds. Recall that, you know, the nattox is is still not a a fully accepted regimen, and that's using being generous fully accepted regimen in the community. Right? It's it's pretty its use in the community is still very limited. And like I said, we we like we said previously, not today, but previously we said, you know, we do think that, in time, it will get there. And our focus has been, you know, we wanna make sure we have, a label within the next three to five years to meet the to meet the the the move of venetoclax into the community setting. The academic centers, we see we definitely see nice uptake, of venetoclax in first line patients. So that's a market that we'd we'd like to be in. And, you know, again, I think the academic centers are very familiar with venetoclax, and they will be familiar with you too. And with compendia listing, like I said, they will do as they wish, and the community is is not quite there yet anyway. And we're still, you know, fingers crossed, we're still, gonna have our first initial launch of u two, later this year, potentially early next year. And, you know, we definitely want some time, to to build the you two as you two before we move on to the combination. So I think the timing I don't perceive it any headwinds. I think the timing is is working out exactly the way we'd want it to. We think there's a lot of value to be derived for you two as you two, particularly in the community, particularly in patients who are either, poor candidates for BTK therapy or, have already seen BTK therapy. We think there's lot of patients out there that will benefit from U2. And then as the data evolves and we move into a world where venetoclax is more broadly available, then U tube plus venetoclax should be labeled at that point. And that we believe has a shot at becoming, you know, standard of care for for first line treatment and and certainly in patients who have already seen a BTK across both academic and community centers. So I think there's time for this market to evolve, and we're gonna be, I think, lined up perfectly in a time frame for that. So I don't think there's any headwinds, in my opinion. Okay. Got it. Thanks for taking the question. Maybe I have one quick follow-up if I could. In terms of site, locations or geographies that the phase three Ultra V phase three is is recruiting from, do you, is it primarily in The US, or are you recruiting patients ex US as well? So currently, it's exclusively The US. We are looking at some very high enrolling centers ex US, that we potentially may add to the trial. But currently, it's exclusively a US trial. And those sites are primarily, major academic centers, so which is which is very nice. We have a good good very good group of academic centers. We've expanded even beyond those that were involved in the phase two portion. And for the phase three, we've also, included large community centers that do use venetoclax. And so we're excited to have those folks as part of the trial as well. Okay. Great. Thanks for taking the questions. Thanks, Eric. Our next question comes from Ed White with H. C. Wainwright. Just a follow-up on your European strategy. What you were saying about going alone in in Europe and partner in Japan and China, does that apply for the MS opportunity as well? As of the moment, yes. It does. Okay. Thanks a It's it's a lean ed. It's not we haven't we haven't confirmed it yet. It's a lean right now, just to be clear. We're leaning in that direction. Okay. Then maybe a question for Sean and just following up, about the noncash compensation. You had discussed, that line item for SG and A. I was curious about R and D as well as noncash compensation was up 30% about quarter over quarter. I'm just wondering if there was something onetime in nature in there or if that's sort of the new base. Yeah. Thanks, Ed. I I think the, this is probably the new base for r and d. I think the change there was likely a function of, change in stock price, and a slight add in headcount, but this is probably the new base. Thanks, Sean. And then my last question. Mike, you gave updates on on a few of the products. Can you just give us an update on, fifteen o one? Yeah. So, you know, fifteen o one is is in a phase one here in The US right now in in heme. Obviously, the drug itself is getting close to a registration in the non heme area being developed by another company. But for us, we are we are in the phase one. We're collecting data. It's still very early. I will say that we've had some challenges with that enrollment because PD one, PD L one is is not viewed very attractively in in heme malignancies, which is unfortunate. I think I think there is a role, and it needs to be vetted out. I just think some early work was was was not was not overly positive compared to other agents, but I do think in combinations, that's a mechanism that that actually could be very interesting. We're continuing to pursue. We've got adding some additional combinations to help enrollment, and we'll keep you posted. Okay. Thanks, Mike. That's all I have. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed. Hi. Good morning, guys, and thanks for taking the questions. Just wanted to focus a little bit on the initial use you're seeing of Yukonique, I guess, in the community versus the academic setting. You're saying that it was about fifty fifty, initially. Do you, I guess, expect that to change over time? And and and and when you add, kinda YouTube to the to the commercial, profile, how how do you think that will roll out in terms of community versus academic? Adam? Wanna hit that one? Yeah. Sure. So, yeah, we were we were we were very pleased to see, the split between academic and community and the initial uptake, which we think is is good. As you know and we said before, the vast majority of these patients are treated in the community, but it's dispersed amongst, many, many community physicians, where in the academic centers it is concentrated. So, we certainly have focused on the academic centers, but, also getting out in the community. I will say that, this this split seems about right to me. I think we'll we'll continue to track it and see as far as your question about know, what we see, how this will change going forward. You know, I think it could, as as the the product becomes more widespread use, across the community, it could could go up across, community centers, if anything. Was there a second question beyond that? No. Think that was it. You you covered. Yeah. Okay. And then I guess maybe, I don't know if this is for you, Adam, but, I guess you you mentioned in your prepared remarks that you're, you know, getting good payer coverage, you know, 85, 90 percent. Has there been any issue in terms of, patient access even though with that coverage in in place? Are you are you seeing any, access issues with with patients either, getting getting coverage or reimbursement and, and that kind of thing? Nothing that is not typical for for for for a launch product. So I think everything that we've seen is normal as we get on formularies. And so, no, we've not seen any issues. And then, I guess last question in terms of the ultimate, one and two, Phase III trials. As you're thinking about commercialization preparation there, how should we think about that product as differentiating in the marketplace? So thanks, Matt, for that. Yeah. So, obviously, we were super pleased with the results from from ULTIMATE one and ULTIMATE two. You know, the the easiest differentiator in the marketplace will be certainly the one hour infusion. We're also working. Our payer group is is actively studying and and and and meeting with payers to better understand what it will take to create the best access possible for patients with obetuximab. So as we've noted multiple times that if we can identify a price that will enhance access for patients, we will we'll do that. So we think that there's a price differentiator. And then on the clinical profile, look, you know, we'll leave it to the experts to say. But, you know, in our opinion, we've got of the best data that's ever been seen in the treatment of MS. We think that the annualized relapse rates are incredibly, low, in the obetuximab arm under point one zero, which is, as many of you have heard or listened to the calls, a pretty big hurdle, in the MS landscape. With relapses, you know, the lower, you know, patients who see lots of relapses, it's usually connected with disability progression. These are, you know, it's relapsing, remitting disease. You have a relapse. Not every relapse results in disability progression. So but but very few patients will progress with their disability without in the absence of relapse. So keeping those relapses down is obviously super important, and that's why it's part of the endpoint for these trials. So yeah, we think that the profile across the board, every one of the endpoints on the efficacy side looks as good if not better than anything else that's out there today. So we feel that safety and efficacy look quite good. We've got really nice differentiation on convenience, and hopefully, we'll have a differentiator on price. Our next question comes from Mayank Bantani with B. Riley. This is Sahil Kazmi on for Mayank. Our questions. Just a quick one for Mike as it relates to the Phase III ULTRA V study, could you talk to the kind of thought process and rationale about having U2 as the active comparator arm and kind of any underlying assumptions on surrogates like ORR, PFS, and maybe any key learnings from the CLL 14 program with Vanita Klaks and Gazeta? Yeah. I mean, I think we from from the studies that are being run currently, I think the, venetoclax, vosabrutinib trial are using GazyvaCalambrosol as the control still. So we think, you know, U2 is a, based on our studies, a very active control arm. It's also a control arm that we're familiar with. We we understand the properties profiles, and and we've run clinical trials with YouTube before quite extensively. So, for us, it was kind of a natural go to. The expectation, of course, is that YouTube, by the time the study would read out, will be a an approved regimen in, in CLL, both in frontline and relapse settings. So it seems kind of a natural, and and for us, it does help to separate. Obviously it's U2 plus venetoclax versus U2 alone so we get to see a very nice comparison to the control arm versus using a sort of a non regimented control arm that we're testing. So I think for us it was kind of natural to use u two. And we think going forward, other companies are likely to use u two as a control arm as well as GC becomes less usable going forward. Our next question comes from Craig Suvanesh with Goldman Sachs. Please proceed. Thank you very much. Good morning, everyone. Thanks for taking my questions. I've got maybe two. One, just, as we think about, the current, uptake, and congrats on on seeing for sales. Any any color? And I think you provided some high level comments early in your prepared remarks just how to think about, progression of the uptake, throughout the balance of the year, particularly around kind of expectations on post COVID vaccination world and and kind of when you expect kind of an an inflection, if there is going to be one. And then, second for me would be, just thinking about your product portfolio in terms of, having products in two different, therapeutic areas, oncology, and then MS. And just wondering if you could provide your perspective around kind of where you see the, most tangible synergies, you know, between those two, if there are any, and and maybe it's more back end versus, obviously, you know, sales reps and tactics or strategy? Thanks. Sure. Thanks, Greg. Adam, you wanna talk about the uptake of Eutonic and maybe progression and potential COVID inflection points? Sure. Yeah. I mean, you know, I think it's it's still early, obviously. We're we're enthused by the positive reactions we're seeing to Yukonix profile. However, these are small patient populations, and we've had a limited time so far to determine any definitive trends. But, you know, I think with, the increase of live engagements and restrictions sort of loosening hopefully over the next few quarters, we hope that increased engagements, will lead to meaningful, discussions about the product and hopefully adoption. So I think it's, just to summarize, think it's a little too early to say, and we'll see how it goes, but, we're enthused that we can get in front of physicians and have, these conversations moving forward. Thanks, Adam. And to your point on the portfolio and the two therapeutic areas, I guess, you know, first and foremost, it starts with the science. Right? So these are all diseases that are characterized by aberrant b cells. Obviously, in in cancer, you've got malignant b cells. And on the MS and autoimmune side, you've got these aberrant b cells that are are part of the immune autoimmune cascade. I think scientifically, there there's a big overlap and, you know, it's sort of a natural the ability to, maneuver our compounds in both therapeutic areas, because of their their underlying science is is I think important to us and and important for for why we're doing this. In terms of other tangible synergies, you know, I think in terms of the commercial side, we're gonna we're gonna obviously need to build a a cells and medical team that are focused on, on MS. But I do think that a lot of the, commercial pieces that we've built in terms of operations and organization, will support, the focus in both therapeutic areas. So there's there's more to build, but the, the over overlay into the current, organization, I think, is a is a pretty nice, synergy across both indications. Adam, I don't know if you have anything more to add on the commercial side. No, Mike. I think you covered it. Okay. Okay. Thanks so much. Thank you. At this time, I would like to turn the call back over to mister Mike Weiss for closing comments. Great. So just wanna, again, thank everyone for joining us. Had a nice start to the year, and, and we're looking forward to, to some exciting additional things to come for the remainder of the year. So let me just summarize some of those. First, we're going to continue to execute on the commercial VUCONIC, commercialization of VUCONIC in both relapsed and refractory margins on follicular lymphoma. Sort of a next potentially big thing coming up is we're waiting to to hear from the FDA whether they've accepted our BLA for filing for for U2 in both previously untreated and relapsed or fractured CLL. And then assuming positive news and they accept that filing, we'll be looking for working closely with the agency to get that application approved as quickly as we can. We're gonna complete the BLA submission for ublituximab and RMS. Again, that's targeted for the third quarter of this year. And as part of that, and as we're gonna be preparing our commercial organization for, for potential launch in in CLL. And and, obviously, we're gonna be working also on the build out for ublituximab and RMS, which got a little more time for. If the third quarter is the target for the filing, the target for approval would be, about twelve months after that. So 4Q of twenty two would be the target there. So then we get the application in to this year. So a little bit of time, but, again, we're we're working on that as well. And then beyond that, we're continuing to advance our our pipeline. You know, we've got UltraV phase three trial. We're looking to potentially move TG-seventeen oh one into a Phase III this year as well. And then the earlier pipeline, we've got eighteen oh one and fifteen oh one that continue to progress. As asked him one of the questions later this year, we're looking forward to presenting data on the U2 plus venetoclax combination, more data from seventeen oh one or BTK inhibitor both at ASCO and later this year. And as I noted, possibly phase one data from t g eighteen o one or c d forty seven, c d 19 bispecific antibody. So very busy remainder of the year. We're we've got a lot to execute on. We've got a a great team coming together on all fronts. So that is our update. So on behalf of everyone here at TG, again, wanna thank our every one of you for the support and for joining us today. Have a great day. Thank you. This does conclude today's teleconference. You may disconnect your lines at this time, and thank you for your participation, and have a great day.