Earnings Labs

TG Therapeutics, Inc. (TGTX)

Q1 2021 Earnings Call· Mon, May 10, 2021

$34.77

-1.72%

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Transcript

Operator

Operator

Greetings, and welcome to the TG Therapeutics Q1 2021 Earnings Conference Call and Business Update. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jenna Bosco, Senior VP of Corporate Communications. Please proceed.

Jenna Bosco

Analyst

Thank you. Welcome everyone. And thanks for joining us this morning. I’m Jenna Bosco and with me today to discuss the first quarter 2021 financial results and provide a business update are Mike Weiss, our Executive Chairman and Chief Executive Officer; and 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 development 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&A session. Before we begin, I'd like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks that may 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 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 30 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.

Mike Weiss

Analyst

Thank you, Jenna. And thanks everyone for joining us this morning. With the recent accelerated approval of UKONIQ, for the treatment of relapsed or refractory marginal Marginal Zone Lymphoma and Follicular Lymphoma, TG has transitioned into a full integrated commercial organization. We are extremely pleased to now have UKONIQ, the first and only dual inhibitor of PI3K-delta and CK1-epsilon available to patients. We see the approval of UKONIQ as the first step and our broader mission of developing novel treatment for patients with B-cell diseases. With successful Phase 3 studies in chronic lymphocytic leukemia refer to CLL and multiple sclerosis, MS, already completed and reported. We see the potential to positively impact, a significantly larger group patient on the horizon. Beyond that our pipeline has the potential to deliver novel combinations building up of a foundation of UKONIQ and ublituximab, our U2 combination that can further enhance outcomes for patient with B-cell diseases. Before I hand over the to our Chief Commercialization Officer, Adam Waldman to discuss the UKONIQ launch and preparations for the potential CLL and MS launches. I wanted to review some of our recent accomplishment as well as the current status of our ongoing programs. First and foremost as I mentioned at the outset of these depend remarks, in February, the FDA corrected accelerated approval of UKONIQ for the treatment of adult patients with relapsed or refractory marginal zone lymphoma, who have received at least one prior anti-CD20 base regimen and for adult patients with relapsed and refractory follicular lymphoma, who have received at least three prior lines of systemic therapy. This approval was primarily based on the results of the UKONIQ monotherapy cohorts of the UNITY-NHL Phase 2b trial. And the approval came just surely after the final results from the trial were presented at the…

Adam Waldman

Analyst

Great. Thanks, Mike. And I'm very excited to provide a commercial update on the UKONIQ launch as we report revenues for the first time. With this launch, we're not only bringing important new option to patients, but we are setting the foundation for multiple potential future approvals, including the combination of UKONIQ ublituximab known as U2 and 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 UKONIQ'S differentiated profile, drive adoption with our targeted customers, ensure a positive first experience, and as I mentioned, set the foundation for TG and lymphoma as we plan for anticipated launch of U2 and CLL. In our first partial quarter, we achieved 0.8 million of net sales of UKONIQ. UKONIQ is the first and only inhibitor of PI3K delta and CK1 Epsilon is the unique treatment options 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 UKONIQ is a different -- 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 discontinuous -- discontinuation, and a lack of a black box warning are important differentiators with healthcare providers and payers. We believe that these factors help establish your conic in a class of its own. We recognize the second line marginal zone and fourth line plus follicular lymphoma are labeled indications represent relatively small patient populations. Therefore, our strategy out of the gate has been a target the higher volume prescribers…

Sean Power

Analyst

Thank you, Adam. And thanks again to everyone for joining us. Earlier this morning, we reported our details first quarter 2021 financial results, which can be viewed on our website@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 million in cash, which we believe will be sufficient to take us into 2023. As Adam noted earlier, following the FDA's accelerated approval of UKONIQ on February 5, we were pleased to report $0.8 million of UKONIQ net revenue in the first quarter. Our net loss for the first quarter of 2021, excluding non-cash items was approximately $74 million, compared to approximately $40 million in the first quarter of 2020. The increase we've seen in net loss as compared to the first quarter of 2020 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 UKONIQ, which occurred in the first quarter of 2021. Additionally, during the first quarter of 2021, we saw an increase in R&D expenses over the 2020 period, which was primarily driven by one time licensing milestone payments of approximately $14 million, consisting in large part of a $12 million mile due on approval of UKONIQ. Our GAAP net loss for the first quarter of 2021, inclusive of non-cash items was $90.6 million or $0.69 per share, compared to a net loss of $51.1 million or $0.48 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&A.

Operator

Operator

Thank you. At this time, we will conduct a question and answer session. [Operator Instructions] Our first question comes from Alethia Young with Cantor Fitzgerald. Please proceed.

Alethia Young

Analyst

Hey, guys. Thanks for taking my questions. And Congrats with the launch. A couple. One, can you talk maybe a little bit about the breakout, roughly in kind of between MZL and follicular, just 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, I was curious, just on obviously, kind of early feedback around some of the -- with GI tox that have been seen 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.

Mike Weiss

Analyst

Adam, do you want to-- if you -- I don't know if you have any information yet on breakout between follicular marginal zone and stocking question?

Adam Waldman

Analyst

Sure. Yes. 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 estimate exactly the breakdown. But we've seen usage in both. So, we were very happy to see that. As far as the stocking questions, given that there are many practices, we only see a few follicular marginal zone patients per year. We anticipate pharmacy ordering generally to be on an as needed basis. So we have placed some inventory with distributors to fulfill pharmacy orders consistent with industry norms for a product like UKONIQ. And then, I think the third question was GI tox.

Alethia Young

Analyst

Yes. That's one.

Adam Waldman

Analyst

Yes. So far, so good. 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 and know how to treat it if they see it. But so far, so good.

Alethia Young

Analyst

Great. Thank you.

Operator

Operator

Our next question comes from Chris Howerton with Jefferies. Please proceed.

Chris Howerton

Analyst · Jefferies. Please proceed.

Hi, good morning. Congratulations on all the progress, obviously, commercial and R&D. And thanks for taking the questions.

Mike Weiss

Analyst · Jefferies. Please proceed.

Thanks, Chris.

Chris Howerton

Analyst · Jefferies. Please proceed.

Yes, absolutely. And so let's see, I guess, first off for the -- I just don't recall, what the status was and maybe some information around the designs for the confirmatory studies for follicular and marginal zone, just maybe some updates or some color on that side of the story? And then, moving towards the end of the year. So I just maybe wanted to get 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, 1701 at ASCO. But just maybe what are kind of the key highlights and data expectations for ASH at the end of this year, if you might? Thanks.

Mike Weiss

Analyst · Jefferies. Please proceed.

Sure. So, on the confirmatory trial, don't want to say too much yet. We have noted in the last part of the approval, we had a basic design discuss with the FDA, but we do need to finalize that. So I think it's going to be in and around what other companies have announced previously from their confirmatory trials. And our hope is to get it up and running before year end. And we'll give a lot more detailed of time. But again, there's a relatively standard trial design that's out there, that other companies within [Indiscernible] panelists and then journalists have announced. And I think we'll be sort of closer mindset to those kinds of studies. In terms of pipeline updates this year. So, as I noted, we'll have some more information on 1701 at ASCO. And I've been relatively vocal that I was pretty pleased with the results that we saw at ASH. I've encouraged folks to take those results and line them up with other BTKs both covalent and non-covalent, and see for themselves, 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 ASH later this year. For ASH as well, as I noted in my prepared remarks, we do hope to have twice as many patients or approximately twice as many patients. So nearly 50-ish patients available for that 12 months end point for U2 plus venetoclax Phase 1 trial. So that is what I'd say is the goal for U2 plus venetoclax would be that data set. The Phase 1 follow up on -- I assume that to follow-up on all patients to that point, or close to all patients. And then for the…

Chris Howerton

Analyst · Jefferies. Please proceed.

Okay. All right. Well, that's certainly a lot going on. And then, I mean, maybe just to remind us the Phase 2 portion of the Ultra-V study, that does have the possibility to have a registrational implication. Is that right?

Mike Weiss

Analyst · Jefferies. Please proceed.

Yes, it is possible. It's something that's probably going to be somewhat challenging as a single arm with multiple drugs. But once we have all the data put together, we'll definitely have a conversation with the FDA 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 that 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 potential update to the NCCN guidelines. Our Phase 3, when we roll into the enrollment phase, and so that'll be ongoing. And both drugs are approved. And obviously, we would not be marketing at all, to U2 plus venetoclax. Both physicians are capable of making their own decisions. And again, both drugs would be approved in the indications that someone might use them. So, again, we'll at best have something that's useful for Companhia listing. I mean, best case scenario would be approval. But the second option would be, it'll be useful for Companhia listing. And that's pretty good, too. And then like I said, the registration trial is ongoing.

Chris Howerton

Analyst · Jefferies. Please proceed.

Yes. Okay. All right. Very good. Well, thanks again, Mike. Appreciate it.

Mike Weiss

Analyst · Jefferies. Please proceed.

Thanks, Chris.

Operator

Operator

Our next question comes from Josh Schimmer with Evercore. Please proceed.

Josh Schimmer

Analyst · Evercore. Please proceed.

Thanks for taking the questions. A few primarily housekeeping questions. For SG&A, the non cash comp cadence. Can you help us understand, it looks like a second half loaded at least over the last 18 months? Is that by designers or is that coincidence? And then for the R&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-U.S. commercialization for territory is for to have the rights for a number? Thanks.

Mike Weiss

Analyst · Evercore. Please proceed.

Thanks, Josh. Sean, do you want to hit on the SG&A and R&D milestones? And I'll talk about the ex-U.S.?

Sean Power

Analyst · Evercore. Please proceed.

Sure. I think the SG&A non-cash account being back loaded last year. So, we're certainly not by design. I think it was a function of the commercial build. Certainly last year prepping for the UKONIQ launch. I think it'll probably be a bit more level in 2021. Although as we do continue to ramp for a potential CLL launch. You might see a slight trend upward again in the second half. In terms of R&D milestones left for potentially 2021. There is a milestone due to LFB on the approval of ublituximab. So should that -- should we be fortunate enough for that to come in 2021? That would be a 2021 milestone.

Mike Weiss

Analyst · Evercore. Please proceed.

Okay. What's approximate that milestone, Sean.

Sean Power

Analyst · Evercore. Please proceed.

Low double-digit.

Mike Weiss

Analyst · Evercore. Please proceed.

Okay. Excellent. Okay. And then in terms of ex-U.S, Josh, we are we're still working out the details there. Adam and his team have been doing kind of impressive [ph] evaluation of what's the best approach there. We've given ourselves a little bit of time to make those applications after the approvals for U2 and for ubli and MS. So we're going to focus here in the U.S. We're working towards approvals here. And then we'll work towards the approvals abroad. So, a little bit of time to make that call. But I would say, and Adam can confirm that this team is leaning towards 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 value to be extracted, but probably the major European markets that lien today is toward doing it ourselves.

Josh Schimmer

Analyst · Evercore. Please proceed.

And what are the timelines for registration in Europe?

Sean Power

Analyst · Evercore. Please proceed.

So, I think the filings will remain probably six to 12 months after we have the approvals here in the U.S.

Josh Schimmer

Analyst · Evercore. Please proceed.

Thanks very much.

Sean Power

Analyst · Evercore. Please proceed.

Thanks Josh.

Operator

Operator

Our next question comes from Eric Joseph with JPMorgan. Please proceed.

Eric Joseph

Analyst · JPMorgan. Please proceed.

Hi, good morning. Thanks for taking the question. The couple. First on UKONIQ commercials. Do you have a sense of repeat prescribing patterns so far? And what are you unsure -- what are you anticipating in terms of growth in new patient adds, and duration on therapy over the course of 2021? And then just following up on the question about the registration potential Ultra-V. Again, how should you be thinking about approval timeline to the Phase 3 trial if the Phase 2 in and itself isn't strong enough for approval. And the Phase 3 trial represented at all headwind to U2 commercial, assuming they will do expansion at the start of the year? Thanks.

Mike Weiss

Analyst · JPMorgan. Please proceed.

Sure. Thanks. answer those questions. Adam, you want to tackle the first to the UKONIQ commercial.

Adam Waldman

Analyst · JPMorgan. Please proceed.

Yes, certainly. Eric, it is still early, but the good news is we have seen refills. And we've also seen physicians prescribing for more than one patient. So we think this is a really positive indicator. But it is still early as far as duration goes, we'll see. Obviously, we're doing everything we can to educate physicians and healthcare providers on managing patients and keeping a month therapy. We think that is key to our future success.

Eric Joseph

Analyst · JPMorgan. Please proceed.

Right. Thanks, Adam. And in terms of the approval timelines for Ultra-V Phase 3. We think there's probably going to be 12 to 18 months approval period. And that'll be followed by similar probably 12 to 18 months of follow up. Now, there's two groups here that -- so we have to separate. This is separate studies almost built into the one study. So we have a cohort for relapsed, refractory. We have a cohort for frontline. So they could enroll at different paces. And certainly the follow up on the relapsed, refractory 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 24 to 36 month timeframe. And the frontline probably a little bit longer. I don't think there's really too much in terms of headwinds. Recall that, venetoclax is still not a fully accepted regimen and using being generous fully accept the regimen in the community, right. It's pretty -- it's used in the community still very limited. And like I said, we were said previously, not today, but previously, we said, we do you think that in time, we'll get there. And our focus has been, we want to make sure we have a label within the next three to five years to meet the meet the move of venetoclax into the community setting. The academic centers, we see -- we definitely see nice uptake of venetoclax in the first line patients. So that's the market that we'd like to be in. And again, I think the academic centers are very familiar with venetoclax. And…

Eric Joseph

Analyst · JPMorgan. Please proceed.

Okay. Got it. Thanks for taking the question. Maybe one quick follow up if I could. In terms of site locations or geographies that the Ultra-V Phase 3 is recruiting some. Do you -- is it primarily in the U.S. or including patients ex-U.S. as well?

Mike Weiss

Analyst · JPMorgan. Please proceed.

So currently, it's exclusively in the U.S. We are looking at some very high enrolling centers Ex-U.S. that we potentially may add to the trial. But currently, it's exclusively U.S. trial. And those sites are primarily major academic centers. So which is very nice. We have a good -- very group of academic centers. We've expanded even beyond those that were involved in Phase 2 portion. And for the Phase 2, 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.

Eric Joseph

Analyst · JPMorgan. Please proceed.

Okay, great. Thanks for taking the question.

Mike Weiss

Analyst · JPMorgan. Please proceed.

Thanks, Eric.

Operator

Operator

Our next question comes from Ed White with HC Wainwright. Please proceed.

Ed White

Analyst · HC Wainwright. Please proceed.

Good morning. Thanks for taking my question. And just a follow-up on your European strategy. What you're saying about doing alone in Europe and partner in Japan in China. Does that apply for the MS opportunities as well?

Mike Weiss

Analyst · HC Wainwright. Please proceed.

As of the moment, yes, it does.

Ed White

Analyst · HC Wainwright. Please proceed.

Okay. Thanks again.

Mike Weiss

Analyst · HC Wainwright. Please proceed.

Again, for lean, it's not -- we haven't confirms yet it’s a lean right now, just to be clear. We're leaning in that direction.

Ed White

Analyst · HC Wainwright. Please proceed.

Okay. And then maybe a question for Sean. And just following up about the non cash compensation. You had discussed that line item for SG&A. I was curious about R&D as well as non cash compensation was up 30%. about quarter-over-quarter. I'm just wondering if there was something one time in nature in there, or if that's sort of the new base?

Sean Power

Analyst · HC Wainwright. Please proceed.

Yes. Thanks, Ed. I think the -- this is probably the new base for R&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.

Ed White

Analyst · HC Wainwright. Please proceed.

Thanks, Sean. And then probably last question, Mike gave updates on a few of the products. Can you just give us an update on 1501?

Mike Weiss

Analyst · HC Wainwright. Please proceed.

Yes. So, 1501 is in a Phase 1 here in the U.S. right now and Hem obviously, the drug itself is getting close to a registration and in the non-hem area, being developed by another company, but for us, we are we are in the Phase 1. We're collecting data. It's still very early. I will say that we've had some challenges with enrollment because PD-1 PDL-1 is not viewed very attractively in hem malignancies, which is unfortunate. I think there is a role is to be vetted out. I just think some early work 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. So we're continuing to proceed with adding some additional combinations to help enrollment. And we'll keep you posted.

Operator

Operator

Okay, Thanks, Mike. That's all I have.

Operator

Operator

Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed.

Matt Kaplan

Analyst · 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 UKONIQ, I guess in the community versus the academic setting. You're saying that it was about 50/50? Initially, do you, I guess expect that to change over time? And when you add kind of U2 to the commercial profile, how do you think that will roll out in terms of community versus academic?

Mike Weiss

Analyst · Ladenburg Thalmann. Please proceed.

Adam? Do you want to take that one?

Adam Waldman

Analyst · Ladenburg Thalmann. Please proceed.

Yes, sure. So yes, we were very pleased to see the split between academic and community and the initial uptake, which we think is good. As you know, when we said before, the vast majority of these patients are treated in the community, but it 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 split seems about right to me. I think we will continue to track it and see as far as your question about what we see how this will change going forward? I think it could -- as the product becomes more widespread use across the community, it could go up across community centers, if anything. Was there a second question beyond that?

Matt Kaplan

Analyst · Ladenburg Thalmann. Please proceed.

No You covered. And then I guess maybe, I know, this to you, Adam. But I guess you mentioned in your prepared remarks that you're getting good payer coverage, 85%, 90%. Has there been any issue in terms of patient access, even though with that coverage in place? Are you seeing any access issues with patients either getting coverage or reimbursement and that kind of thing?

Adam Waldman

Analyst · Ladenburg Thalmann. Please proceed.

Nothing, that is not typical for a launch product. So I think everything that we've seen is normal as we'd get on formularies. And so, no, we've not seen any, any issues.

Matt Kaplan

Analyst · Ladenburg Thalmann. Please proceed.

And then, I guess, last question, in terms of the ULTIMATE I and II, Phase 3 trials, as you're thinking about commercialization preparation there, how should we think about that product has differentiating in the marketplace?

Mike Weiss

Analyst · Ladenburg Thalmann. Please proceed.

So Thanks, Matt, for that. Yes. So obviously, we were super pleased with the results from ULTIMATE I and ULTIMATE II. The easiest differentiator in the marketplace would be certainly the one-hour infusion. We're also working. Our pair group is actively studying and meeting with payers to better understand what it will take to create the best access possible for patients with ublituximab. So, as we've noted multiple times that if we can identify a price that will enhance access for patients, we will do that. So we think that there's a price differentiator. And then on the on the clinical profile, look, we'll leave it to the experts to say. But in our opinion, we've got some 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 ublituximab arm under .10, which is, as many of you have heard and listened to the calls, its a pretty big hurdle in the MS landscape. With relapses, the lower patients who see lots of relapses, it's usually connected with disability progression. These are relapsing remitting disease. We have a relapse. Not every relapse results in disability progression. So -- but very few patients will progress with their disability without the absence of relapse. So keeping those relapses down is obviously super important. That's why it's primarily for these trials. So yes, we think that-- the profile across the board, everyone in the influence 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 will look quite good. We got really nice differentiation on convenience. And hopefully we'll have a differentiate on price.

Matt Kaplan

Analyst · Ladenburg Thalmann. Please proceed.

Thanks, Mike. That's very helpful. And congrats on the progress again.

Mike Weiss

Analyst · Ladenburg Thalmann. Please proceed.

Thanks, Matt.

Operator

Operator

Our next question comes from Mayank Mamtani with B. Riley. Please proceed.

Sahil Kazmi

Analyst · B. Riley. Please proceed.

Hi. Good morning. This is Sahil Kazmi on from Mayank. Thanks for taking our questions. Just a quick one from us maybe. As it relates to the Phase 3 Ultra-V study. Could you talk about the kind of thought process and rationale about having U2 as the active competitor arm? And kind of any underlying assumptions on surrogates, like our ORR, PFS and maybe any key learnings from the CLL-14 program with venetoclax and GAZYVA?

Mike Weiss

Analyst · B. Riley. Please proceed.

Yes. I mean, I think we -- from the studies that are being run are currently, I think the venetoclax was ibrutinib trial or using GAZYVA chlorambucil as the control still. So we think U2 is a based on our studies, very active control arm. It's also a control arm that we're familiar with. We understand the properties profiles and we've run clinical trials with U2 before quite extensively. So for us it was kind of a natural go-to. The expectation of course is that U2. By the time the study would read out, will be at a an approved regiment in CLL, both in frontline and relapse settings. So it seems kind of a natural 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 us U2. And we think going forward, other companies are likely to use U2 as a control arm as well as GC becomes less usable, going forward.

Sahil Kazmi

Analyst · B. Riley. Please proceed.

Absolutely, definitely makes sense. That's it from us. Thanks very much for taking the questions and congrats on the quarter.

Mike Weiss

Analyst · B. Riley. Please proceed.

Sure. Thank you.

Operator

Operator

Our next question comes from [Indiscernible] with Goldman Sachs. Please proceed.

Unidentified Analyst

Analyst

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, I'm saying for sales. Any color, and I think you've provided some high level comments early in your prepared remarks just have to think about progression of the uptake throughout the balance of the year, particularly around kind of expectations on post COVID vaccination world and kind of when you expect to kind of function, if there is going to be one? And then second, for me, it 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 synergy between those two, if there are any, and maybe it's more back end versus obviously, sales reps, tactics or strategy? Thanks.

Mike Weiss

Analyst

Sure. Thanks Craig. Adam, you want to talk about the uptake of UKONIQ and maybe progression and potential inflection points?

Adam Waldman

Analyst

Sure. Yes. I mean, I think it's still early, obviously, we're enthused by the positive reactions we're seeing to UKONIQ profile. However, these are small patient populations than we've had a limited time so far too definitive to determine any definitive trends. But, I think with 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, I think it's a little too early to say, and we'll see how it goes. But we were enthused that we can get in front of physicians and have these conversations moving forward.

Unidentified Analyst

Analyst

Thanks Adam. And to your point on the portfolio in the two therapeutic areas, I guess, first and foremost, it starts with the science, right? So these are all diseases that are characterized by aberrant B-cells. Obviously, in cancer you've got malignant B cells and on the MS and autoimmune side, you've got these aberrant B-cells that are part of the immune autoimmune cascade. So I think scientifically, there's a big overlap and sort of a natural, the ability to maneuver our compounds in both therapeutic areas, because of their underlying sciences is, I think, important to us and, and important for why we're doing this. In terms of other tangible synergies. I think in terms of the commercial side, we're going to we're going to obviously need to build a sales and medical team that are focused 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 over overlay into the current organization, I think has pretty nice synergy across both indications. Adam, I don't know if you have anything more to add on the commercial side?

Adam Waldman

Analyst

No, Mike. I think you covered it.

Mike Weiss

Analyst

Okay.

Unidentified Analyst

Analyst

Okay. Thanks so much.

Operator

Operator

Thank you. At this time, I would like to turn the call back over to Mr. Mike Weiss for closing comments.

Mike Weiss

Analyst

Great. So, just want to again, thank everyone for joining us. We had a nice start to the year. And we're looking forward to some exciting additional things to come since the remainder of the year. So let me just summarize some of those. First, we're going to continue to execute on the commercial of UKONIQ, commercialization of UKONIQ in both relapsed and refractory marginal zone and follicular lymphoma. As sort of a next potentially big thing coming up is we're waiting to hear from the FDA whether they've accepted our BLA for filing for U2 both previously untreated Relapsed and refractory 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 just quickly as we can. We're going to 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 we're going to be preparing our commercial organization for potential launching in CLL. And obviously, we're going to be working also on the build out for ublituximab and RMS. which we got a little more time for and if the third quarter is the target for the filing, the target for approval would be about 12 months after that. So 4Q of 2022 would be the target there's. And so when we get the application and after Q [ph] to this year. So a little bit of time. But again, we're working on that as well. And then beyond that we're continue to advance our pipeline. We've got Ultra-V Phase 3 trial. We're looking to potentially move TG 7101 into a Phase 3 this year as well. And then the earlier pipeline, we've got 1801 and 1501, that continue to progress. As asked one of the questions later this year, we're looking forward to presenting data on the U2 plus venetoclax combination, more data from 1701 or BTK inhibitor both at ASCO and later this year. And as I noted, possibly Phase 1 data from TG 1801 and our CD-47, CD-19 bi-specific antibody. So very busy remainder of the year. We've got a lot to execute on. We've got a great team coming together on all fronts. So that is our update. So on behalf of everyone here at TG, again want to thank everyone of you for the support, and for joining us today. Have a great day.

Operator

Operator

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.