Earnings Call: Q2 2021

Aug 2, 2021

Greetings. Welcome to TG Therapeutics Second Quarter twenty twenty one Earnings Call and Business Update. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. At this time, I'll now turn the conference over to Jenna Bosco, Senior Vice President, Corporate Communications. 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 second quarter twenty twenty one financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer Adam Waldman, our Chief Commercialization Officer and Sean Power, our Chief Financial Officer. Following our safe harbor statement, Mike will provide an overview of our recent corporate developments as well as an update on our current pivotal programs and remaining key goals for 2021. Adam will then 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'd like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory milestones, clinical development plans and expectations for our marketed and pipeline products. TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings, including our most recent reports on Forms 10 ks and 10 Q. In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward looking statements. This 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 would like to turn the call over to Mike Weiss, our CEO. Great. Thank you, Jenna, and thanks everyone for joining us today. During the first half of twenty twenty one, we hope that our long term goals and vision for TGI TGI really come into focus for investors. With first phase of our multiphase strategy now complete with the accelerated approval of Yukonic, the first and only dual inhibitor of p I three k delta and c k one epsilon for the treatment of relapsed or refractory marginal zone lymphoma and follicular lymphoma. We are very proud of these accelerated approvals for patients who have failed prior therapies and have limited treatment options. We estimate approximately eight thousand patients each year will be seeking treatment in our approved MZL and follicular indications, which we see is an excellent starting point for our commercial efforts. Building on momentum from our YUCONIC launch, we have submitted and received a PDUFA target goal date of 03/25/2022 for a BLA application requesting approval of the combination of YUCONIC plus ublituximab, our novel glycoengineered anti c d twenty monoclonal antibody, the combination of which we refer to as u two for the treatment of patients with chronic lymphocytic leukemia. We have also submitted a supplemental new drug application, sNDA, for Yukonic for the same indication and have received the same PDUFA date for the sNDA. We are excited about the potential to bring our novel u two combination to CLL patients, especially those who have failed or or who are not good candidates for current standards of care. CLL is a significantly larger patient population than marginal follicular. We currently estimate that approximately thirty to forty thousand patients will be seeking a new treatment each year in a proposed CLL indication. Not only is CLL multifold larger patient population than marginal follicular, but we would expect the median duration of treatment to be longer in CLL as well. One other important factor to note is that we believe about eighty five percent of our target prescribers for marginal of follicular lymphoma are the same prescribers that we'll be targeting that we will be targeting for chronic lymphocytic leukemia. So the significant efforts our team has made in building relationships for the marginal zone of follicular launch should translate nicely into our potential CLL launch. Next up in our multiphased approach is the largest patient population we'll we'll we will be addressing, which is patients with the relapsing forms of MS with ublituximab as a single agent. We are targeting a submission of a BLA for MS this quarter and hope to receive a target PDUFA date in the third quarter of next year. We believe our phase three data supports an attractive treatment option for patients with the relapsing forms of MS. Entering MS will also raise our commercial profile significantly as we expect to participate as one of only three anti c d 20 monoclonal antibodies in what has been been projected to become a 10 to $15,000,000,000 per year market just for anti c d twenty monoclonal antibodies in the treatment of MS. While the core focus will be on the regulatory and then commercial execution of these first three opportunities, especially the larger market larger market opportunities in CLL and MS, we will continue to seek to enhance our hematology oncology franchise by broadening the potential u two label to new indications, such as in marginal zone and follicular lymphoma and also into new combination uses of u two in CLL, for example, in combination with venetoclax and our very own t g seventeen o one. The ability to combine with standard of care agents in CLL, we hope will bring better outcomes to patients and should also broaden the potential penetration of u two and CLL. On the MS side, we will seek to build on ublituximab, potentially in other auto inflammatory diseases, as well as seek to build additional programs in MS. With that, let me provide some recent highlights related to our initial commercial launch efforts with Yukonig and our key regulatory efforts and development programs. First, let me just remind everyone and restate that in February, the FDA granted accelerated approval of Yukonak for the treatment of adult patients with a relapsed or refractory marginal zone lymphoma who have received at least one prior anti c d twenty based regimen and for adult patients with relapsed or refractory follicular lymphoma, whoever received at least three prior lines of systemic therapy. This approval was based primarily on the results from the UNITY NHL trial, which were recently published in the Journal of Clinical Oncology. On the commercial side, Vuconic became commercially available a few weeks following approval. And overall, I can say we're extremely pleased with the performance of the commercialization efforts to date. Launching during a global pandemic is no easy task. But under the circumstances, the team has done a really nice job in engaging target prescribers both commercially and educationally under the leadership of our chief commercialization officer, Adam Waldman. Adam will join us shortly to discuss some launch metrics and give some high level qualitative assessments of the launch thus far. I don't wanna steal his thunder, but, again, from where I sit, the launch is going well and believe it's positioning us for future success with the potential approval of u two for CLL early next year. Speaking of which, and as noted above, the BLA and sNDA for u two in CLL have both been granted a PDUFA target goal date of 03/25/2022. For the MS program, we were pleased in the second quarter to be able to present the positive results from our ultimate one and two phase three trials evaluating gulpetuximab in relapsing forms of MS at two major conferences, the American Academy of Neurology annual meeting and the European Academy of Neurology annual meeting. As mentioned during our last call, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate referred to as ARR with ublituximab treatment resulting in historically low levels of ARR. We believe these results are highly encouraging and showcase the potential of ublituximab to provide an efficacious treatment option in a one hour infusion every six months following the first dose. The expert feedback we have received thus far has been very positive, and our one hour infusion is viewed as an important benefit for both physicians and and especially their patients. These trials were conducted under special protocol assessment with the FDA, and we are on track to complete a BLA submission for lupatuximab to treat RMS this quarter. And briefly, before I turn the call over to Adam, I wanna provide a quick update to our combination and pipeline programs that we hope will be drivers of future growth. Starting with u two plus venetoclax, which has moved forward now into phase three for patients with CLL within the Ultra V trial. The phase two portion of the Ultra V study completed enrollment earlier this year. You may recall that at last ASH in December, doctor Paul Barr of the Wilmette Cancer Center in Rochester, New York presented preliminary results from his phase one study of the u two plus venetoclax combination, which included results from the first twenty seven patients in the study to complete the 12 cycles of fixed duration therapy. In those patients, there was one hundred percent overall response rate, and greater than seventy five percent of the patients achieved undetectable MRD in the bone marrow. We view these results as highly encouraging, and we look forward to presenting updated data from this phase one trial later this year with approximately double the number of patients through 12 cycles of treatment. Next, let's discuss t g seventeen o one, our investigational BTK inhibitor. We were pleased to present updated results from the phase one trial of t g seventeen o one as a monotherapy and in combination with u two last month during the summer oncology meetings, including ASCO, EHA, and ICML. We were pleased to see that with additional patients treated with t g seventeen o one, it continued to show encouraging clinical activity paired with what appears to be a tolerable safety profile. As I mentioned earlier, we view these triple therapy trials as a way to enhance the utility of u two in the treatment of CLL. Further in the clinical pipeline are our c d 19, c d 47 bispecific antibody referred to as t g 18 o one and our p d l one antibody referred to as t g fifteen o one or cozabellumab. Both are moving through early stages of testing with the possibility of data later this year or next. 2021 has been a very busy year for us as we've made significant progress on both the clinical and regulatory fronts and look forward to an impactful end of year and into 2022 as we strive to expand our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our chief commercialization officer, Adam Waldman, to share some highlights from our early commercialization efforts. Adam? Yeah. Thanks, Mike, and I'm very excited to provide a commercial update for the first full quarter of the Yukonix launch. Let me start with some numbers and then provide some qualitative assessment. As you've already seen in the financial press release, we achieved $1,500,000 in net sales of YUCONIC for the second quarter, which was our first full quarter of sales. While we were quite pleased with the extent of our launch penetration, which by our estimates reflects YUCONIC capturing three percent to four percent of new patient starts in our labeled indication. In our view, that is a great starting point that is ahead of our internal projections. Importantly, our net sales figure doesn't fully capture the total demand for YUCONIC seen this past quarter as the amount of free YUCONIC provided to patients through our patient assistance program has been significant. Many of our patients are covered by Medicare Part D, and their out of pocket costs are very high due to the Part D benefit design. In addition, unfortunately, unlike CLL, there's a general lack of financial assistance available to support marginal zone and follicular patients with their out of pocket costs at the current time. This dynamic is leading to a high percentage of patients qualifying to receive free products. To give you a sense of the extent of the free product offered, we provided over 35% of Yukonix bottles to patients free of charge through our patient assistance program in the second quarter. As we have said over and over, we are committed to helping patients access our products, and we are proud to be able to help those in need by providing Yukonix free of charge. When we look at the volume when we look at the the volume of our overall demand, which includes free product, we are extremely pleased by the early uptake for Yukonix. As we've stated before, our goal with this initial launch is to get as many accounts, prescribers, and patients to have a positive experience with YUCONIC as we build towards the potential CLL launch early next year, and we believe ensuring patient access is a strong step towards achieving that goal. Based on these early trends and current assumptions, we are targeting 7,500,000.0 to $12,500,000 in net sales for the full year 2021, assuming a similar rate of free goods for the remainder of the year to support Yukonak for those who cannot afford it. And further, we would expect to see nice growth in our net sales for 2022. And currently, we are targeting net revenues for 2022 to be between 50,000,000 and $75,000,000 assuming an approval of U2 by the March 25 PDUFA date, allowing for partial sales of U2 in both frontline and relapsedrefractory CLL and a small contribution from ublituximab in MS for which we hope to have a third quarter twenty twenty two PDUFA date, all of which puts us on pace for our 2025 goal of achieving $1,000,000,000 in corporate wide sales. Now let me provide some additional color beyond the numbers. While it is still early into our launch, we are pleased with our execution and believe we have made significant progress to date. Our strategy has been to focus on the approximately 1,000 higher volume community and academic accounts, representing approximately 3,000 hematologist oncologists that see the vast majority of the eligible patients in our indications. What we have seen is that most of the initial adoption has occurred within these targeted accounts, and in fact, a large percentage of the initial utilization is coming from centers that were involved in our clinical trials. In many cases, we are seeing repeat prescribing at these accounts as well, which we also view as a positive sign. And although still early, we are pleased with the initial refill rates we are seeing, which we view as a reflection of both the clinical profile of Vuconic and that providers are effectively navigating potential toxicities and keeping patients on therapy where appropriate. This growing experience builds comfort and confidence for our expanding prescriber base, and our team is doing a fantastic job with educating and supporting clinicians and safely managing patients. We continue to receive very favorable feedback on the Yukonok clinical profile. Insights from our recent launch tracking studies show how how, show strong product performance, message recall, product perceptions, and importantly, intent to prescribe when physicians have appropriate patients. When our teams have engaged our our target health care providers, they see Uconic as having a differentiated profile and view it as a valuable treatment option for both relapsedrefractory marginal zone and follicular, patients. However, gaining access to our customers remains a challenge. COVID related restrictions have persisted, affecting our ability to access all of our targeted accounts. And although the situation did improve modestly throughout the quarter, with an increasing percentage of our of in person engagements, the most recent trends in the Delta variant have caused some institutions to reinstitute certain visitor restrictions, potentially reducing the opportunities for in person engagements in the coming weeks and months. One other important COVID related trend relates to patient visits. Marginal zone and follicular, as you know, are relatively small patient populations to begin with, and most physicians only see a few of these patients that fall within our labeled indications in a given year. But it appears that since the onset of COVID, patient visit and treatment starts have decreased in endo lymphoma across the board. Most of these patients are elderly and may have been reticent to visit oncology offices during the pandemic. We believe this continues to be an issue, and we have not recovered back to pre pandemic numbers quite yet. These trends make our initial uptake even more impressive and essentially bode well for increasing patient flow once the pandemic is behind us. Another positive note, another positive note is that payer coverage has not been a challenge to date. The team has done an exceptional job here. We have, been able to achieve broad coverage of Econic very quickly. More than ninety percent of commercial and Medicare lives have confirmed coverage to our label or NCCN compendia. We are committed to making sure that each and every eligible patient and health care provider has a positive experience with TG and YUCONIC. When a health care provider and their patient have a positive experience with Yukonic with strong educational and access support from the TG, team, we believe that the health care provider will be more likely to prescribe Yukonic for additional appropriate patients in the future. We also believe that this will carry through to their CLL patients assuming approval of u two. As Mike mentioned, we estimate there's roughly an 85% overlap of health care providers within our target base across, lymphoma and CLL, reinforcing the importance of what we're doing in establishing our footprint with this launch. So with that, I'd like to thank you very much, for being here, and and, I'd like to hand it over to Sean, Powell. Thank you, Adam, and thanks, everyone, again for joining us. Earlier this morning, we reported our detailed second quarter twenty twenty one financial results, which can be viewed on the Investors and Media section of our corporate website. For today's call, I'll keep my remarks remarks brief and touch on a few highlights from the quarter, beginning with our cash position. We ended the second quarter with approximately $456,000,000 in cash, cash equivalents, and investment securities, which we believe will be sufficient to take us into 2023. As Adam noted earlier, we are pleased to report $1,500,000 of YUCONIC net product revenue in the second quarter, our first full quarter of product sales. Our net loss for the second quarter of twenty twenty one, excluding noncash items, was approximately $62,000,000 which was a decrease of $12,000,000 quarter over quarter from Q1 of twenty twenty one, where we saw a net loss excluding noncash items of approximately $74,000,000 Given that q one of this year was our first quarter as a fully commercial entity, it's probably a more apples to apples comparison to what we saw this quarter. As compared to the first quarter of twenty twenty one, the decrease of approximately 12,000,000 was primarily driven by onetime licensing milestone payments of approximately $14,000,000 occurring in Q1 of this year. If we shift and compare this quarter to Q2 of twenty twenty, where we saw a net loss excluding noncash items of approximately $46,000,000 That increase is primarily related to increased selling, general and administrative expenses associated with the launch of Yukonix and planning for the potential future launches of U2 in CLL and ublituximab in RMS. Our GAAP net loss for the second quarter of twenty twenty one, inclusive of noncash items, was $78,500,000 or $0.59 per share compared to a net loss of $52,900,000 or $0.47 per share during the comparable quarter in 2020. With that, I'll now turn the call back over to the conference operator to begin the Q and A. Thank you. At this time, we'll now be conducting a question and answer session. Thank you. And our first question is from the line of Alethia Young with Cantor Fitzgerald. Please proceed with your questions. Hey guys, thanks for taking my questions and congrats on the early progress with the launch. Maybe just a couple for me. One, just I wanted to get a little bit more color about how you were talking about during kind of the COVID trends. Just how much penetration has occurred into the roughly around, I guess, 3,000 heme oncs? And kind of how that kind of ebbed and flowed like or it sounded like it might to slow a little bit in light of the Delta variant? And then my second question is just as far as a differentiated clinical profile like an MZL and follicular especially on the safety, I just wanted to get some color around, you know, how's that going and some of the early experience? I know it's still super early, but just any kind of color you can provide there. And then I was intrigued by kind of the when you said the $20.25 dollars 1,000,000,000 in sales, like can you give us a little bit of framework about how to think about what that breakout might be between like multiple sclerosis and the hematology indications? Thanks. Yeah. Sure, Mike. You want me to take those? Hello? Shoot. I'm sorry. Yes. Yes. Please, Adam. I was on mute. Yeah. Okay. Okay. Yeah. At least, yeah, thank you. This in the over the line is is a little tough. So sorry. So the first question around penetration, we are we are you know, I think, given the pandemic, we're and as I've mentioned before, we we've we've hired a really experienced team, that came in here with relationships and and, existing connections. So our penetration has been very good, especially in the top centers. The issue is with just with frequency and just how often you can get into these centers. You know? And and with a new product, it does take multiple visits sometimes to discuss the full the full profile, the mechanism, the patient populations, and and it does take some time with the so so to answer your question, penetration has been good, especially into the top accounts. We're working on frequency. We're starting to see that. And as I mentioned, things did get modestly better in the in in the second quarter. We were seeing increases in live engagements, which we think is a more effective way of communicating. However, with the Delta variant, in the last few weeks, we are seeing a reversal of those trends. And so it's getting, we're starting to see, you know, cancer centers start to restrict, live engagement again. So we'll have to watch that and see how it goes. But in in general, we feel like live engagements are better. Our pay her penetration has been good, but, obviously, it's a it's a fluid situation. Alethia, can you remind me of the second question? Oh, feedback on, like, kind of the use, you know, as far as the safety differentiation that could be seen with UConnex? Yeah. I mean, the feedback has been really positive on on the the profile. They see it as very differentiated. As I mentioned before, the lack of a black box warning is is, seen as as differentiating versus, the other p I three k's out there. And I think, you know, it just just takes time for when they see a patient and and when a patient presents themselves. And, you know, these these patients don't show up on an individual physician basis, that often throughout the year. So, when, we're able to get good frequency of of, interaction and a patient shows up, that's when, we're getting used. But the feedback on the product has been, very, very positive. And then as far as the breakdown in the, 1,000,000,000, you know, as I mentioned, we expect a small contribution from MS given that we're expecting a late in the year approval there. We expect to get some contribution from you too given that we would have three quarters of use of use of and our ability to promote U2 in CLL starting in the second quarter is our expectation. And then, we know the continued launch of Marginal Zone and follicular will continue, to form the base, of the revenue projection. Alethia, just to clarify, Adam was referring to 2022 in his answer. Oh, 2022. Oh, got it. Yeah. Yeah. Yeah. Sorry. Yeah. The date of 2020. That was that was for 2022. For the for the 1,000,000,000 in 2025, I don't think we've we've gone as far as to say that. But I I think, you know, I think at that point, we should be at a fifty fifty or trending toward a larger contribution from MS at that point. Okay. But the models that we have in forecast, there there is some flux between, you know, bull and and and bear cases. And and so I think we're we're giving ourselves a little bit of flexibility there as well. Okay. Cool. I guess just follow-up. Just, you know, you talked about these 8,000 follicular MZL, which, I mean, could be a sizable opportunity itself. So I guess I was trying to get a feel between 2022 and 2025, you know, how confident you are in being able to kind of penetrate this core group over time. Yeah. I mean, I think in terms of marginal follicular, we feel pretty good about the the potential for for penetration. Again, I, you know, I don't I don't know what, you know, peak penetration, you know, expectations are overall. But, I mean, I think if we were, you know, 20% to 30% penetration, that would be pretty fantastic, in any group where there's multiple drugs available. Awesome. Great. Thank you. The next question comes from the line of Josh Schumer with Evercore ISI. Please proceed with your questions. Thanks so much for taking the questions. First on reimbursement and access, how do you expect it to evolve from here for YUCONIC or for U2? Are there reasons to expect it will improve? And if so, what would those reasons be? Second, if you could discuss the pathway for full approval of YUCONIC and what you expect it will take to achieve that? And then last, maybe you could talk or even consider kind of rank ordering the obstacles to YUCONIC adoption. How much of it is COVID? How much is reimbursement? How much of it is awareness? How much is competitive therapies, and and how you think those obstacles may alleviate in the coming months and years. Thank you. Yeah. Adam, why don't you go ahead with, some reimbursement access and where you see things heading? Sure. Yeah. Thanks for the question, Josh. On the access and reimbursement front, we really haven't seen many challenges. I think, as I mentioned, we have, achieved broad coverage, the broad payer coverage, and and are not experiencing, any issues with regards to that. I think what you may be getting to well, we can clarify, but that's I think we're we're good on the access and reimbursement side. I'll take the obstacles and and and competitive question, and I'll let you, Mike, talk about the full approval. Yep. You know, I think the obstacles you know? Yeah. I mean, launch as Mike mentioned in his remarks, launching in a pandemic is is difficult. You know, when we get in front of physicians, as I mentioned, they're they're they have a very positive feedback on on the product, but that's when we get in front of them, and and and we're continuing to to make progress there. And when we have those interactions, they are largely very positive interactions. And and, from our market research, it shows that they see it as a differentiated product and and one in which, is very compelling for marginal zone and and follicular patients in our in our indications. You know, there is, I think the obstacles are the COVID and just getting access. I think there is, some, you know, decrease in patient visits or patient treatment starts just given the reticence of some patients, as I mentioned, coming in to start a new treatment. And, you know, I think those are the, the biggest challenges, and I think they will, you know, hopefully alleviate when we get, further down the line, and get away from the pandemic, going forward. And, and, Josh, on the pathway for full approval of Yukonak, so I guess two two points. One, the the CLL, UNITY CLL trial will ideally support a full approval of Euconic and CLL. And then converting the margins on follicular accelerated approval into a full approval will require a randomized trial that we're in the process of finalizing the, the design with with the FDA. And, hopefully, that study will commence before, before year end. The concept there will be some some trial that will be in slightly earlier lines of follicular and then randomized trial with with Eutonic. Adam, maybe you can kinda clarify on the reimbursement, the 35% free drug, whether that's something you expect to continue or whether that may improve going forward. And if so, why? Yeah. I gotcha. Okay. Yeah. Good to clarify. So, yeah, I mean, you know, in marginal zone of follicular specifically, we're seeing a general lack of co pay support, funds, available for Medicare Part D patients. A large part of the a large percentage of our patients in this, specific indication are Medicare Part D over the age of 65. And specifically in in larger than follicular, we're we are not seeing, availability of co pay funds. We do expect that that would change with CLL. We we see much more funding available in CLL, and this is much less of a, an issue in CLL. And then MS is a different, different ballgame altogether. We're talking about largely commercial patients, so so not not as relevant. But, so, you know, we would expect, this to persist for this year. And then, as we get into CLL, we would expect it to to come down as a as a as an overall issue given the funding that's available in in that patient population. Thanks very much. Thanks, Josh. Thank you. Our next question is from the line of Eric Joseph with JPMorgan. Please proceed with your question. Good morning. Thanks for taking the questions. The first is around your 2022 sales guidance. I'm just wondering what that anticipates in terms of CLL penetration and whether there is any anticipated impact to Yukonic net price as combo therapy as opposed to use a single agent in particular marginal zone. And then I'd also be curious to get a sense of what your latest thinking is around the European or EU commercial and regulatory strategies across the different franchises both in in hemoLiganty as well as in RMS. Thanks. Thanks, Eric. Adam, do wanna take a crack? You want me to take a crack at the first one? Yeah. Go why don't you start, and then I'll I'll I'll win. Yeah. So, you know, in terms of of CLL and in terms of penetration, I think we're we're assuming given the the point in time of the year that we'll get launched, which will be probably into the second quarter, that there'll be, obviously, some contribution from CLL in, in the year. In terms of the, the amount of penetration, you know, I think we're even, using even more modest penetration numbers than, than we found, than we were seeing right now with, with Euconic, in in MZL in follicular. And so, you know, we've been pretty conservative, in in those in those assessments. And then in terms of the Euconic pricing as part of the package, yeah, we we have not, we have not finalized, pricing yet, so it's hard for us to give too much detail because, again, I don't think anyone knows what the, we haven't given any guidance on the ilvetuximab pricing. But it's but there most likely will be some discounting to to Yukonic in that setting. But it's really it will become a function of of what we, what we price, where we price obetuximab, and and we'll come together to basically come up with a total price that we think is is is fair, for the patient population. Got it. Second. Yes. Sort of latest thing on approaching the European commercial opportunity perhaps with the various product franchises. Yeah. So we're, we're in the process of scoping that out still. We're, we're moving forward with, I think we're working toward I think the first application don't yeah. I I think I've gotta go back and check with the regulatory team. But the first application in the in Europe may be in MS. So we may actually end up staging it MS first and then CLL second there. But I think I need to probably get back to you on that. But we are definitely moving forward. We think that, you know, the MS opportunity in Europe is a is a very interesting one for us and one that's managed, probably more cleanly, with a smaller team, certainly than we required in The US. And that pricing in in Europe will be a big driver of, of uptake. So we're still exploring that to make sure that those assumptions are valid. But assuming that's the case, we think there's a pretty interesting opportunity for for European loss launch in MS, while we're still continuing to scope out, you know, how that pricing interplay with CLL, will occur. So I think for the moment, I'm pretty sure we're gonna head forward with, with MS, first and then CLL second, ex US. Okay. Okay. Great. Thanks for taking the questions. Appreciate it. Thanks, Aaron. The next question is from the line of Chris Howerton with Jefferies. Please proceed with your questions. Great. Thanks so much for taking the questions. Congratulations on all the progress. I think from me, of course. First, with respect to the YouTube plus venetoclax trials, I guess I couldn't quite remember what the regulatory path is. Would the phase two study be sufficient for an accelerated approval opportunity? I guess it's just a pretty simple question. And then, you know, with respect to the phase two study itself, you know, what would be the expected data disclosure? I know there was, at least in my head, some anticipation that we would get those some of the data at ASH, but might not be the full result. So I guess some thinking around that, would be helpful. And then the last question was, you know, just ensuring that, everything is good to go with respect to, CMNC, particularly as it relates to ublituximab. Thank you. Sure. So in terms of the YouTube Venn program, we've been we've been focused on three almost three full phases. Right? So we had a phase one that doctor Paul Barr conducted as a lead investigator, and that phase one is where we is what we've presented previously at last year's ASH, and it's what we've been committing to present later this year an update too. So I think we have 27 patients through twelve months the first go around, and we're looking for somewhere between forty and fifty patients through twelve months for the completion of of the patients in that trial. So that is the that is the YouTube Venn data that we've been talking about as being presented later this year. In terms of Ultra V, as we've said, the the enrollment completed early in earlier this year into the phase two portion. And so that data, to have all the patients through twelve months, would not occur until after well after ASH. And in fact, we would need and to be prepared for ASH, you'd need probably two months prior data. So the the Ultra V dataset, as I've noted multiple times, would be incomplete for this ASH. And if we could present a partial dataset or not was really a function of of what the principal investigator wanted to do. And so we're still trying to figure that out, today, whether we'll do a partial dataset. But, you know, my my general feeling is that it it probably will not occur this year. If and I've said this in multiple occasions. If it were if it were me and I was the PI and we were that close to the you know, to having all patients through twelve months, I wouldn't wanna release a partial set when I could do a full set, you know, within a reasonable time frame of that. So, we'll wait to hear back from the PI and and what his decision is, but, I think from where I sit, I I wouldn't be surprised at all. And in fact, I'd be surprised if he said he wanted to present the partial data. We'll see we'll see where it goes. But for the moment, the phase one is where we'll see the the YouTube Venn data later this year, and UltraV is more likely than not gonna be a more complete dataset next year. And then in terms of the regulatory side of that question, you know, once we have the full phase two data through through the at least all the patients through the twelve month time point. We'll look at that data, and we'll have a conversation with the FDA. Ideally, you know, you two will be approved at that time. So, hopefully, it'll it'll have a an easier pathway for from the FDA to approval of Mhmm. U two already being approved and venetoclax already being approved. But as we've, again, said multiple times, there's there's no assurance that that phase two data will be usable for for approval. If it is not usable for approval, of course, the phase two portion will be published. We'll certainly, send it over to NCCN and and see if they're interested in adding it to their guidelines. And the phase three is enrolling as we speak. So that's the current status of of that program. Great. Okay. That's awesome. And then I guess just any anything to note on, CMMC? Nothing nothing to note that that, you know, we filed the CMC. I think it was the first section we filed as part of the rolling submission for ublituximab for for the CLL application for Oobli. And, you know, to my knowledge, there there's been a dialogue back and forth. The FDA has been reviewing that file. And as typical, you know, of any filing, there's there's questions that come in and go back out to the FDA, and and that is the the process that is ongoing. But nothing nothing to the team's great concern as far as I as far as I know. Okay. Fantastic. Well, thank you, Mike. Appreciate it, and I hope to talk to you soon. Thanks, Chris. Next question is from the line of Ed White with H. C. Wainwright. Please proceed with your question. Good morning. Thanks for taking my questions. So maybe the first question to Sean. You gave some guidance on SG and A expenses trending higher. I was wondering if you can make any comments on R and D. I know there was the $4,000,000 charge in the quarter, but how should we be thinking about the second half of this year? Sure. Thanks, Ed. So SG and A trended higher over last year, over last second quarter, of course, as you'd expect given the commercial launch. I think it'll it'll continue to to tick up a little bit over the course of, the rest of this year, as I said, as we prepare the CLL and MS launches. And I wouldn't I wouldn't expect all to all that much on the on the r and d front. I would say, you know, not not a whole lot of volatility there, over the remainder of the year. Okay. Great. Thank you. And then, Mike, just some pipeline questions. You had just commented on ULTRA V Phase two. Can you give us any, update on how the phase three enrollment is going? Are are there any trends you can look at now to let us know when you think the trial will be fully enrolled? And then you had mentioned data later in this year, for the phase one trial. I'm just wondering for the other, combinations and drugs in development, you know, what we could potentially see at ASH this year. Sure. So in terms of full enrollment into ultra vated, it it's way too early, unfortunately, to give any kind of good projection. You know, enrollment only started, about a month or two ago. So it's it we're in very early days. For early stage of a trial, it's going, quite well. But, obviously, we're gonna you know, we gotta see a a big ramp at some point, and, and then I'll have a better sense of of what the the the target enrollment time frame, would be for that. In terms of data from the rest of the pipeline, for later this year, You know, certainly, we continue to enroll more patients in in the 17 o one study in the BTK. So that one will will continue to to eke out data at all the conferences, keep people updated on on the progress of that program. And then with, c d 47 c '19 and and '15 o '1, you know, those are those are continuing to to be in the early stages. And we again, I I cannot promise data this year, as I noted, potentially later this year. For sure, next year. I mean, we will have certainly something present by next year, but potential for later this year. So I think in terms of what to expect during the remainder of this year, the I'll put in close the final data from the phase one of u two plus VEN. We'll see sometime later this year. More up to date more updated data on seventeen o one, to come out. And, you know, I'm sure there's I know this the team is working on, you know, subanalysis of all the different trials. So there's other things that people are working on. But in terms of of data sets that, you know, you have visibility out for the moment, I think those are probably the two the two primary data sets that are that are remaining, and like I said, some sub analysis that we'll we'll be coming out with. Okay. Thanks, Mike. And then my final question is you mentioned, when you were talking about MS, other auto inflammatory disease indications and other forms of MS. I was just wondering, you know, how should we be thinking about that that potential? Should we be seeing potential studies start in in next year, or is this, you know, further down the road than that? Yeah. I mean, I think it's possible to see some studies starting next year. We're we're working on a few concepts. And if they come, you know, to fruition, then, yeah, I would expect, you know, some things to to start some studies to start next year. We'll keep you posted for sure. Okay. Thanks, Mike. Thanks, Ed. Our next question is from the line of Greg Savannah with Goldman Sachs. Please proceed with your questions. Yeah. Thanks. Good morning. I've got a couple of questions if I could. One, just on Yukonic, and it might be too early for you to comment, but can you provide an update on number of accounts that you've penetrated? You know? And if and this might certainly be too early, but if you're seeing any reordering, I'm just trying to get a sense of what the ordering pattern dynamic, might be for YUCONIC. And then a follow-up on YUCONIC is, you know, it seems as if the way you're positioning the product relative to the portfolio is that it's, you know, you know, a very good product for patients and prescribers to get an overall good experience with TG Therapeutics? And, with that in mind, I was wondering if you might be comfortable providing what you currently believe that the peak revenue opportunity of Yukonak, might be. And then moving beyond Yukonak, just looking at the MS landscape, any color that you might be able to provide would be appreciated just on what you're seeing in the anti c d 20 marketplace. Obviously, you've got Ocrevus there, and Kesimpta is relatively new. But just wondering if if you can comment on just how you're seeing Kesimpta, you know, in that launch and how that's having an impact either on Ocrevus alone or just the overall anti c d 20 market, in general. Thanks. Sure. Actually, Adam, you wanna start the the last question? I'll work our way backwards through. There's some questions about accounts and reordering on the Econic side, but maybe while that question is fresh, maybe some MS commentary. Yeah. Sure. Yeah. We just saw, I think Roche and Novartis just just, had a conference call last week. There was some, dialogue around their their launch there, so we're we're looking at that. It looks like there was some recovery, you know, from, earlier in the pandemic. Looks like they're they're continuing to get some traction, in the anti c v 20 space. The the class itself is is, on a growth trend. Kesimpta is getting some traction, in in the market, but, both seem to be holding steady, and it's not growing, now again, you know, as the pandemic continues on here. But, so we're we're encouraged by it. I think, you know, the physicians that we talk to, continue to be very, excited about the class, excited about the use of the product earlier and earlier in ing the disease. So we think it's, good trends overall and that the, you know, the class itself is growing, which we think is is very positive. Let me talk about the Yukonic. I think the first question was around accounts and reordering. As I mentioned, you know, we we are seeing you know, where we're seeing usage is in our top accounts, in the highest volume accounts. The split that we're seeing is about sixty forty academic to community. We're seeing, we are seeing reordering, from from accounts. We don't have the the specificity as a lot of it's going through specialty distributors, so we don't have the, you know, the preciseness that we'd we'd like to, and and perhaps we'll look into for for future calls. But, you know, as I mentioned, you know, we're we're getting good penetration in our top accounts, and most of our usage is coming from there. And and we are seeing reordering. And then I think there was a question around peak revenue in I think it was specifically for Yukonic. And I don't know if that question was around margins on follicular specifically, but, you know, our our our view on that has not changed. You know, we still see this as being a a significant revenue opportunity. You know, I think might remind me what we've said in the past. Yeah. Yeah. So I'll I'll take that one. So so in terms of the the positioning of Yukonic and MZL and follicular as a basically, as a as a way for us to introduce TG to to the world. That's, you know, that's been something that we said, you know, a year before the launch, six months before the launch, after launch, and and now four months after the launch. We continue to believe that the the YUCONIC introduction in marginal follicular is, you know, most most important is not about revenues. It's about, you know, introducing interesting TG and YUCONIC for future impact primarily CLL. And we said that consistently, we've said we think it's still marginal. Could be a, you know, a few hundred million dollar revenue opportunity over time. I think that you know you know, remember, we're we're taking away almost 40% of all sales right now. And if that's a trend that continues, you know, it's a pretty big discount. But, again, we think, certainly, at at the point in which there's a few hundred million dollars of of revenue potential, you know, TG could be in a position to to, help fund with, hopefully, with others, charitable organizations that can provide, support for those patients. So I think it's, you know, at at these levels, it's interesting to see that, you know, we're giving away, so much for YUCONIC. But like I said, we made this very clear, that we wanted to to have a great experience for Yukonic in marzano follicular. And, you know, we did not anticipate, giving away almost 40% free goods. But having said that, that's fine. We're we're happy to do it if it if it builds goodwill in the industry, and and we wanna make sure patients all have access. So I think in terms of, the consistency of that message, we've been extremely, consistent about, where we're positioning this launch. Again, having said that, you know, I think in terms of penetration that we've seen, we've we've exceeded our expectations, to date. And I think if we, you know, continue to grow in this marketplace and achieve somewhere in the order of 20% to maybe even as high as 30% depending on, you know, in a bull scenario, Marzona Follicular, a few hundred million dollar opportunity. Again, you know, we've never and we continue to say that, you know, the the company is not being built on on the back of the revenues from certainly from the the launch phase of Marzona follicular, but we are gonna be built on the impression and the positive feedback we get from the Econic launch in marginal follicular. Yeah. And, Craig, just to clarify that the my my comments on the reordering. We're seeing reordering both in terms of, multiple patients from the same accounts, and we're seeing a reordering, in terms of, you know, refills as well. So just wanted to clarify that. Okay. Thanks for that. Thanks, Greg. The next question is coming from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question. Hey. Good morning, guys, and thanks for taking the questions. Just a little follow-up on the Ultra V program. Can you give us some more color, I guess, on the Ultra V phase three study design? Are there specifically, are there any differences from the phase two portion of the study? So the phase three study design is is u two plus VEN versus u two. In terms of the the actual treatment with u two plus VEN, the I gotta double check for you, Matt, but I I think we may be using potentially up to three months more of VEN, than we used in the, in the in the phase two portion. But that was only, again, just to match up with the current schedule for then. But let me just double check for you. But, otherwise, not much in terms of differences. Right. Helpful. And then with respect to your BTK inhibitor program 17 o one, you presented some, you know, positive data recently at the medical meetings. What are your current thoughts on the regulatory path forward? Have you identified, I guess, paths or pathways for the product? Can you continue to resolve it? Yeah. I mean, we feel really good about that that molecule. The performance has been, you know, quite impressive. You know, we've spent a lot of time trying to understand the differences between the doses and in terms of tolerability profile. Our our goal has and continues to be to try to identify the most tolerable, you know, most tolerable regimen to to make sure we have the most tolerable BTK inhibitor. So we're we're we're working hard on that. In terms of the the phase three program, the registration, we've got a few good opportunities. We haven't picked the one yet, but I would expect, you know, by by early next year, we'll we'll be in a in a phase three for for seventeen o one. Okay. Very good. And then I I guess lastly, just a a little follow-up on on I think it was Ed's question with respect to autoimmune indications, additional autoimmune indications for ublituximab. What beyond MS, what what's your current thinking in terms of where where you're gonna bring the product next? Yeah. We haven't given any guidance on that yet, Matt, but we're we're scoping out a number of different opportunities. And, as soon as we we have some in place, we'll certainly disclose those. Well, congrats on the the recent progress, and thanks for taking the questions. Thanks, Matt. Thank you. Our final question is from the line of Mayank Mantani with B. Riley Securities. Please proceed with your questions. Good morning, team. Thanks for taking questions, and appreciate the helpful detail here. So just quick one, Adam, on the Iconic launch. Any early color on, you know, what the real world discontinuation and and and maybe progression rate might be just to, you know I know it's early days, but just to, get an handle on what the duration of therapy might be. And then I have a couple of quick follow ups. Yeah. Thanks for the question, Mike. No. I you know, it's it's yeah. I think it's too early, honestly, to to to comment on that. You know, we're we're yeah. It's just too early to comment on that. Okay. Okay. Great. And then, Mike, on the near and long term guidance that, you know, was very helpful. Any color on, you know, the path to profitability, number one? And then also on the 2025 number for sales, does that include a partner for MS sales? It does not include a partner for MS sales. And in terms of a path to profitability, you know, again, I think, you know, if if we achieve our goal of of of twenty twenty five, one billion in sales, my guess is we'll we should be profitable by then. Okay. Great. And and just on the pipeline side, you know, any any anything next we should expect to hear for the c d 19, c d 47? And and maybe a program, you know, you don't talk about much, but, you know, IRAC four is of increasing interest to investors. So just, you know, when and and what we may expect to hit on those two programs, if if you may. Yeah. So in terms of IRAK four, you know, we've been pretty clear that that program is probably not moving forward, for some time now. In terms of the c d 47, c d 19, that one is moving forward nicely. We're we've just opened up, The US and, you know, hopefully, like I said, to have data later this year, if not later this year, then into next year. Okay. Thanks thanks, Mike, and congrats again on the progress. Thank you. Thank you. We have reached the end of the question and answer session, and I'll now turn the call over to Mike Weiss for closing remarks. Great. Thank you very much, and and thanks, everyone, again. So just wanna wrap up today's call by once again reviewing our upcoming key goals and objectives. So, clearly, we're gonna continue to focus on the commercialization efforts of Uconic in relapsedrefractory marzanal follicular, and expand those commercial capabilities, in preparation for a potential launch in of u two and CLL, and also, of course, for ublituximab in relapsing forms of MS. We are working hard towards submitting our BLA for ublituximab in the treatment of, relapsing forms of MS this quarter. And that, of course, as everyone knows, is based on the positive results from the ultimate one and two phase three trials. In terms of, continuing enrollment into studies, obviously, we're gonna push hard on the enrollment into the Ultra V phase three trial and enrollment into, you know, our 17 o one phase two and and and hopefully soon to start a a t g 17 o one phase three trial early next year and, you know, continue to to push forward with the pipeline of 15 o one, which is the PD L1, and 18 o one is c d 47, c d 19. The you know, we've talked at length today about the the potential data presentations for later this year. And, you know, we are working hard, I could tell you, working very hard, to obtain the approval for u two in CLL, by the PDUFA goal date of 03/25/2022. So on behalf of all of us at TG, I'd like to thank everyone for joining us today, and have a great day. Thank you to everyone joining us today. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.