TG Therapeutics Inc (TGTX) Q4 2020 Earnings Call Transcript

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TG Therapeutics Inc (TGTX -0.50%)
Q4 2020 Earnings Call
Mar 2, 2021, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Greetings and welcome to the TG Therapeutics Fourth Quarter and Year-End 2020 Conference Call. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions]

I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Please go ahead.

Jenna Bosco -- Senior Vice President of Corporate Communications

Thank you. Welcome everyone, and thanks for joining us this morning. I'm Jenna Bosco and with me today to discuss the fourth quarter and year-end 2020 financial results and provide a business update are Sean Power, our Chief Financial Officer; Michael Weiss, our Executive Chairman and Chief Executive Officer; and Adam Waldman, our Chief Commercialization Officer.

Following our safe harbor statement, Sean Power will provide a brief overview of our financial results and then turn the call over to Michael Weiss, who 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 Waldman will then provide an update on our commercialization efforts before handing the call over to the operator to begin the Q&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. 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 most recent Form 10-K for the year ended December 31, 2020 and other filings with the Securities and Exchange Commission.

In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. 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.

Now, I'd like to turn the call over to Sean Power, our CFO.

Sean A. Power -- Chief Financial Officer

Thank you, Jenna, and thanks everyone for joining us. As you may be aware, our financial results were released this morning and can be viewed on the investors and media section of our website. I'll kick things off with our cash position. We're happy to substantially strengthened our balance sheet over the course of 2020, allowing us to end the year with more than $600 million in cash, cash equivalents and investment securities.

Turning for a moment to the financial results. Excluding non-cash items, our net loss for the fourth quarter of 2020 was approximately $54.7 million compared to $34 million in the fourth quarter of 2019. The increase we've seen in net loss as compared to the 2019 quarter is primarily related to increased G&A expenses associated with our preparations for the commercialization and launch of UKONIQ, which occurred in the first quarter of 2021.

Our GAAP net loss for the fourth quarter of 2020, inclusive of non-cash items, was $88.2 million or $0.71 per share, compared to a net loss of $39.6 million or $0.44 per share during the comparable quarter in 2019. Our net loss for the year ended December 31, 2020, excluding non-cash items, was approximately $199.1 million compared to $161.4 million for the 2019 year-end. The year-over-year increase in net loss is primarily driven by an increase in commercialization costs as previously discussed.

On the R&D front, we incurred approximately $21 million in licensing milestones during 2020, which was partially offset by a decrease in manufacturing and CMC expenses as compared to the prior period.

The GAAP net loss for the 2020 year-end, inclusive of non-cash items, was $279.4 million, or $2.42 per share compared to a net loss of $172.9 million or a $1.96 per share for the year ended December 31, 2019.

In terms of what we expect moving forward, I think approximately $50 million per quarter for 2021 similar to 2020 is probably in line with our expectations. We expect to see decreases in R&D over the next few quarters, as some of our large trials wind down. However, this will likely be offset by an increase in commercialization expenses over those seen in 2020.

Looking out further, R&D expenses should pick back up in Q4 and through 2022, as we hit peak enrollment in our next generation of pivotal trials, including our MZL and FL confirmation study and our triple therapy trials in CLL. Similarly, in 2022, we will see further growth of SG&A with our potential launches in CLL and MS. Taken together without accounting for revenues, we believe our current cash will take us out into 2023.

With that, I'll now turn the call over to Mike Weiss, our Executive Chairman and CEO.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Great. Thank you, Sean, and thank you, Jenna. Thanks to all of you for joining us this morning.

2021 is certainly off to an exciting start with the recent accelerated approval of our first medicine, umbralisib, now called UKONIQ, for the treatment of relapsed or refractory marginal zone and follicular lymphoma. This was an incredible achievement for the team, and we are thankful to everyone who helped along the way to reach this exciting milestone.

With UKONIQ approval, our Company has transformed into a fully integrated commercial organization, and we are incredibly proud of the progress already made under the leadership of Adam Waldman, our Chief Commercialization Officer, who will join us shortly to provide some color around the early commercialization efforts.

Before I hand it over to Adam, I want to highlight some of the important accomplishments for 2020 that have positioned us for an exciting '21 and beyond. I want to give special thanks to the TG team for working tirelessly to achieve these important milestones.

With that, let's review some of these significant developments over the past 12 months or so. First and foremost, I mentioned at the outset of these prepared remarks, we received the exciting news early last month that the FDA granted accelerated approval of UKONIQ for the treatment of adult patients with relapsed or refractory marginal zone lymphoma or received at least one prior anti-CD20 based regimen and adults with relapsed or refractory follicular lymphoma, who have received at least three prior lines of systemic therapy.

On the data front, December was about as good as it gets for us at TG. At ASH, we presented pivotal results from both our UNITY-NHL trial, as well as our UNITY-CLL trial. For the UNITY-NHL study, the data showed that umbralisib monotherapy demonstrated an overall response rate of 49.3% in patients with relapsed or refractory marginal zone lymphoma and 45.3% overall response rate in patients with relapsed or refractory follicular lymphoma.

For UNITY-CLL, we presented data demonstrating that U2 achieved the primary endpoint of improving progression-free survival over standard of care chemoimmunotherapy and those results were consistent for patients with treatment naive CLL, as well as relapsed or refractory CLL. In addition, there was a significant improvement in overall response rate, the secondary endpoint.

Finally at ASH, we also presented data from the triple combination of U2 plus venetoclax in patients with relapsed or refractory CLL, and also triple combo data from U2 plus TG-1701 in patients with relapsed refractory CLL or other B-cell lymphomas. I do encourage investors to carefully review both of those presentations.

In the U2 ven study, in the 19 patients who completed 12 cycles of treatment, essentially 12 months of treatment, we reported a 100% overall response rate with 96% of the patients achieving undetectable MRD in the peripheral blood and 77% of those patients achieving undetectable MRD in the bone marrow. Also, folks should take another look at the TG-1701 data, our BTK inhibitor. In addition to the U2 plus 1701 combination data, which looked very promising. I would note that the single agent overall response was 95% in the 20 CLL patients treated at the 200 milligram once daily dose level. So clearly, a very active agent.

I would also encourage folks to look at the safety and tolerability of that same 200 milligram dose and compare that to the tolerability and tox profile of the best BTK inhibitors both covalent and non-covalent. I think you'll find it pretty interesting and potentially could be a differentiator.

Also in December, just a few days after the ASH conference, where we presented all that exciting B-cell cancer data, we were excited to announce the much anticipated topline results of our two Phase 3 studies, ublituximab and relapsing forms of multiple sclerosis, our ULTIMATE I and II studies. Both trials met their primary endpoint of significantly reducing annualized relapse rate with a P-value of less than 0.005 in each study. Of particular interest was that an annualized relapse rate of less than 0.10 was achieved in both studies in the ublituximab arms. Something that has been described by KOLs as breaking an important barrier, one that has not been achieved before in any previous MS Phase 3 trial.

As you can imagine, we are very excited about these topline results, and we're working hard to finalize the full data for presentation, including safety and secondary analysis, which is targeted for the first half of this year and will be used to support in ubli, RMS and BLA submission, which is targeted for midyear. As noted, the initial feedback from the KOL community has been very positive and supports our confidence that MS is an important opportunity for TG.

Finally, also in December, based on the positive UNITY-CLL data, we announced that we commenced the rolling BLA submission for ublituximab in combination with UKONIQ, that's our U2 combination, for patients with CLL, for which we are targeting completion of this submission in the first half of this year.

2020 was also a year, where TG's drugs were recognized by a number of high impact medical journals for publication. Including the final Phase 2 results of ublituximab in multiple sclerosis in the multiple sclerosis journal, the final Phase 2 data evaluating umbralisib in patients with CLL, who are intolerant to prior BTK or PI3K inhibitors in the journal blood, the final results from the Phase 3 GENUINE trial evaluating ublituximab plus ibrutinib in patients with relapsed or refractory high-risk CLL was published in The Lancet Haematology. And finally, on the pre-clinical side, data describing the unique immunomodulatory effects of umbralisib was published in Blood Advances, a Journal of the American Society of Hematology.

And last, but certainly not least, in 2020, we stressed into our cash position and as Sean mentioned, we were able to end the year with approximately $600 million in cash. And we also strengthened our team with the addition of approximately 140 new full-time TG team members dedicated to our long-term vision of developing and commercializing novel treatment options for patients with B-cell diseases.

As you can see, 2020 was a data-rich regulatory-driven year, where we grew our organization and paved the way for impactful milestones to be achieved in 2021, starting with the approval last month of UKONIQ in both relapsed or refractory marginal zone and follicular lymphoma.

With that as a segue, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Waldman to share some thoughts on the launch of UKONIQ, following which the operator will begin the Q&A session. Adam?

Adam Waldman -- Chief Commercialization Officer

Yeah. Thanks, Mike, and thanks everyone for joining us this morning. I'm excited to share some highlights on the progress of the UKONIQ launch. Because approval occurred after the close of the fourth quarter, we will not report any sales metrics today. Instead, I will highlight our accomplishments and provide some high level qualitative insights into what we are seeing in the launch so far.

As Mike mentioned, we were extremely pleased on February 5 to receive accelerated approval for UKONIQ in both relapsed and refractory marginal zone and follicular lymphoma ahead of their PDUFA dates. And even with the earlier-than-anticipated approval, especially in follicular lymphoma, which happened more than four months before the PDUFA date, we were fully prepared to launch.

Within hours of the approval, we launched ukoniq.com, initiated distribution of our marketing materials and digital campaigns, and our TG Patient Support program was up and running. Just as a reminder, TG Patient Support is a comprehensive program designed to support patients through their treatment journey and their reimbursement process.

Our field teams across sales, medical, marketing, and access were fully trained pre-approval and started engaging with customers on UKONIQ's label on Day 1. We have since had very positive interactions with physicians, mid-levels, nurses, pharmacists, and administrators since launch. We have had good access to our target accounts and reception to UKONIQ has been overwhelmingly positive. Many are excited to have a new treatment option for patients with these diseases in which there is no standard of care after initial first-line treatment.

Customers have been impressed with the safety and tolerability profile, the lack of a black box warning, low rates of discontinuations, the unique mechanism of action, simple dose modifications and consistent efficacy across both marginal zone and follicular lymphoma. We have trained several -- several expert speakers to help educate the community on UKONIQ, and I've already conducted multiple national and regional speaker programs within the key community oncology networks.

We have also been working closely with our advocacy partners who are excited about the approval of UKONIQ and have been educating the marginal zone and follicular patient community about this new treatment option. We thank them for all they do for patients and we remain committed to supporting the lymphoma community moving forward.

Despite the unprecedented weather in the Central and Southern United States over the past month, UKONIQ left our 3PL facility within one week of approval. The drug is now fully available in the channel through our specialty pharmacy and specialty distributors and prescriptions are being processed. Our market access team along with the medical team has been actively meeting with payers to ensure that UKONIQ is placed on formulary and available to patients.

So far, our conversations with these payers have been very productive and we remain confident we'll achieve broad coverage to our FDA label for UKONIQ. Within days of the approval, we are also pleased to see that the National Comprehensive Cancer Network or the NCCN added UKONIQ to its clinical practice guidelines and compendium for both marginal zone and follicular lymphoma. This is a positive step forward and provides additional support for the adoption of UKONIQ. While we are in the very early days post-FDA approval, we believe the commercial launch thus far is off to a very strong start.

And with that, thank you everyone for your time this morning, and I will turn the call over to the conference operator to begin the question-and-answer session.

Questions and Answers:

Operator

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Your first question comes from the line of Alethia Young with Cantor Fitzgerald. Please proceed with your question.

Alethia Young -- Cantor Fitzgerald -- Analyst

Hey guys. Congrats on all the progress over 2020. It really did play out the way you kind of said it, Mike. I have two questions. One, just -- maybe if you can talk a little bit more -- I know it sounds like it's going quite well with the launch. But just talk a little bit more about -- kind of -- how the market was little -- might have been a little bit hesitant of older PI3 kinases. And just kind of give us some flavor for -- is that evolving? Is it really because of the label, or is it because of the totality? But do you sense that people are more open-minded around kind of the safety profile that UKONIQ provides? And then, the second question is just on -- in multiple sclerosis or in that, with the U2 combination, how are you guys thinking about timelines around maybe starting on other studies may be in like PPMS or in other indications there? Thanks.

Adam Waldman -- Chief Commercialization Officer

Hey, Mike, you want me to start with the first one?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yes, please. I'm so confused. Go ahead, Adam.

Adam Waldman -- Chief Commercialization Officer

Yeah, that's OK. Yeah. Thanks, Alethia for the question. Yeah, we -- obviously, we knew that there was an overhang among the class. But what we're seeing so far is that UKONIQ is seen as differentiated both from a mechanism of action standpoint being specific to the delta and with CK1-epsilon inhibition as well as the safety profile. It is distinctly different from what physicians are expecting with the class. So, that's what we've seen so far and the feedback from the physicians is very consistent with what we thought and what we've seen in the market research as well.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

And on the MS and autoimmune front, I'd say we have not made a decision on how we want to address PPMS, but we are looking at study designs there. We're looking at study designs for switch studies from Ocrevus to ubli and we're also continuing to evaluate some other indications. I'd say our target is to have at least one -- one additional study open before year-end and we'll keep you posted.

Alethia Young -- Cantor Fitzgerald -- Analyst

Great. Thank you.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. You got it.

Operator

Your next question comes from the line of Roger Song with Jefferies. Please proceed with your question.

Roger Song -- Jefferies -- Analyst

Great. Thank you. Congrats on the progress. Maybe one question for Adam is, since this is early to the launch and certainly we see some pretty positive signal, but moving forward like next few quarters, what kind of launch metrics for the UKONIQ for follicular and marginal zone you are expecting to update to us?

Adam Waldman -- Chief Commercialization Officer

Yeah, thanks for the question. So, in future calls, we will obviously report on net revenue. In addition, we will plan on sharing both quantitative and qualitative insights of metrics to demonstrate our progress with our strategy and execution and end-market performance where we see appropriate. I guess -- I guess some examples, maybe -- and I don't -- we're still working through exactly how we're going to do this. For example, may be qualitative customer insights and feedback like I just provided, but we'll look at customer engagement metrics, performance and targeted customer accounts, and of course progress with payer coverage and reimbursement. That's the plan so far, but as I said, we will continue to work on it and -- but hopefully, that answers your question.

Roger Song -- Jefferies -- Analyst

Yeah. That's helpful. Thank you. Okay next question maybe for Adam or Mike. We understand the overhang just following on the Alethia's question for the PI3K class, but since you have seen there's kind of differentiation in the part of feedback from the -- from doctors and I'm just curious, your expectation for the sales ramp up, you're expecting some quick ramp up because the enthusiasm from the physician you have been talking with because we know lots of the community doc already used UKONIQ during the UNITY-NHL or earlier clinical studies.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah, I'll jump in and you can add on top of that, Adam. I mean -- I think we were still from what I said in my communications with the Street, I think we want to take a tempered approach, I mean the early engagement looks quite positive, but we're still dealing with relatively small patient populations with marginal zone and follicular. And I don't want people to assume this thing is going to ramp overnight so rapidly. I mean it could. Adam may give you a different answer, but I think as a corporate answer, I think we want to be very cautious. Marginal and follicular are really great indications for us to start with. But obviously, we're expecting the ramps are really starts to go into play when we start launching into CLL. Adam, you could add on top of that, but...

Adam Waldman -- Chief Commercialization Officer

Yeah, I agree. I mean, we're enthusiastic about the reaction from physicians who are definitely seeing a differentiated profile on -- as I mentioned, on MOA and safety. So that's good. But we don't want to get ahead of ourselves. I think Mike mentioned, this is -- these are relatively small patient populations. It also is an indolent disease, and we still are dealing with COVID and patient there's just not as much urgency as with the acute diseases patients will come in. And -- but it will be paced, and we'll have to watch that and see how it goes. But I agree with what Mike said.

Roger Song -- Jefferies -- Analyst

Got it. Yeah, that's understood, and yeah so -- yeah, good to have some color around expectation. Thank you, Mike and Adam. That's it from me. Congrats again.

Adam Waldman -- Chief Commercialization Officer

All right. Thanks, Roger.

Operator

Your next question comes from the line of Eric Joseph with JP Morgan. Please proceed with your question.

Rahul -- JP Morgan -- Analyst

Hi, good morning. This is Rahul on for Eric. Thanks for taking the questions. Just two from us. Firstly, can you talk about how physicians view the comparative safety profile of Calquence versus Imbruvica. And what's the anticipated competitive dynamic of U2 relative to Calquence. And secondly, should we think about the earliest data readouts from the ULTRA-V trial? Should we expect a top-end readout with response rates or something more mature like a duration of response in PFS?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Sure. So, I'll take a crack at the first question and I crack the second one and Adam chime in. So Calquence versus ibrutinib, again, it's sort of third hand -- we're talking about drugs that aren't ours. But my impression is that there are some folks who believe the Calquence has a marginally better toxicity and tolerability profile over ibrutinib. I think overall, ibrutinib is and will continue to be the market leader in CLL in terms of BTK inhibitors of choice. We've seen in ibrutinib, patients who have grown intolerant, they go on Calquence. I think over 50% of them will continue to have the same issue that they had with ibrutinib of double check those numbers.

But we've did an intolerance study that was showed a much cleaner profile for patients coming off of ibrutinib seeking another therapy in terms of patients that were intolerant, but data we mentioned was published in blood. So I think, whereas U2 fit in -- again, whatever issue is associated with ibrutinib is also associated with Calquence, right? So, they are not separate from the general toxicity profile. You're still going to see about half the patients with bleeding and bruising issues. You're still going to see several percentage of the patients with afib and cardiovascular risk.

And if the patient has pre-existing cardiovascular conditions and/or they have some bleeding risks or they have drug-drug interactions that folks are worried about, particularly, lots of patients need to be on antifungals, all of which are contraindicated with both Calquence and ibrutinib. So, U2 really fits in nicely into patients who either have seen a BTK inhibitor and have come off of tolerability issues or in patients who walk in the door and have some of the issues that I've mentioned. U2 really provides a nice, we believe, opportunity for patients to get a treatment option that doesn't have those issues.

With respect to ULTRA-V, the data -- the study is a single-arm trial. So the most important data is overall response and duration of response. That's typically how the single-arm studies work. Well, of course, over time, follow-up patients, not only for duration of response, but for question for survival and overall survival. But the endpoints for this trial, the primary endpoints, I believe is ORR or CR and we also, I think, very important metrics for this study are rates of undetectable minimal residual disease, which continues to be remarkably high in the early data.

So as we mentioned in the prepared remarks, 19 patients were presented from the U2 Ven Phase 1 program who had completed 12 months of therapy, where we showed 100% overall response rate with a 96% undetectable MRD in the blood and 77% undetectable in the bone marrow. Relative to other therapies, I believe that in relapsed patients, those are the best undetectable MRD rates that have been reported to date.

Again, it's only 19 patients thus far. So, we've got room to grow that. We will have -- by the end of this year, we could have anywhere from 50 to 100 patients potentially to report on with those same metrics. But that's the plan. The next step in that program to get folks a little look ahead is once we complete the enrollment into the Phase 2 portion, the Phase 3 portion of that trial will open. And then, we will be looking for a PFS endpoint that would be usable for a fulfill approval. Hopefully that helps, Rahul?

Rahul -- JP Morgan -- Analyst

Thanks. Thanks. Yeah.

Operator

Your next question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question.

Ed White -- H.C. Wainwright -- Analyst

Good morning, everyone, and thanks for taking my question. So just on the CLL submission. I think Sean had mentioned launches for CLL and MS in 2022. I'm just wondering if we can get your thoughts on a potential priority review if that's possible in an earlier launch of CLL in 2021? And then, I also wanted to get your thoughts on U2 pricing?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. So, we are hopeful that we will receive prior review. We do have fast-track designation, which doesn't fully entitle one to priority review, but we do think that that it puts us on the right track toward a priority review. So, we'll be pushing forward and asking for -- certainly, asking for priority review. And the second question in terms of U2 pricing, I think -- we would anticipate that U2 pricing would be competitive and strategically be able to be priced versus other potential doublets that are available. So right now, we have a -- we have a price for umbralisib while soon at some point price rituximab, but, when we put the two pieces together and using whatever discounts makes sense, we'll be able to put out a price that strategically versus some other doublets that are out there in CLL.

Ed White -- H.C. Wainwright -- Analyst

Thanks, Mike. And, just a question on MS launch. Again, seeking a pricing, so you're launching in MS, similar launch in oncology as well. How should we be thinking about pricing there? Also, where is it going to fit in the -- knowing the data that you know today, where is it going to fit in the changing treatment paradigm in MS?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah, so -- I'll start with the second part of that question and move back to the pricing after that. So, look, our belief and we think the belief of the other participants in the CD20 marketplace are that CD20s are going to be moved earlier and earlier in the treatment algorithm. We think that's -- we're kind of excited to see our netted data at some point. I haven't seen it yet, but no evidence of disease activity is kind of interesting measure and sort of gets people thinking about the halting of the progression of these diseases and the disease process. So assuming that our data and data from the other CD20s continue to support the fact that if you get them on a CD20 early, you can nearly arrest the disease process. That's an exciting opportunity. So again, we think that we'll be moving earlier and earlier. And our positioning within the class of three CD20s. So, we think CD20s will be the largest class of MS treatment options. And we believe that ublituximab has a very important position within that class of three.

As we've noted previously, we think that the one-hour infusion every six months is a very convenient and fits within the practice of MS physicians who'd like to see their patients at least every six months, getting them in with a one-hour infusion is really quite convenient for both the patient and the physicians. And it's quite good for the infusion centers. The ability to move patients in and out and handle more capacity, which is always at a premium.

We're also -- we continue now -- I'll head into the pricing aspect. We've continued and we will continue to maintain that we believe that strategic -- strategically pricing ublituximab is a way for us to gain market share. And we do think that as it stands right now, the -- certainly based on the annualized relapse rate data that we have certainly the -- to date the best results. And we think that obviously will helps the marketing team, but our goal is to bring every lever to the table to try to optimize our market share within what we believe is going to be the largest market opportunity for MS.

Ed White -- H.C. Wainwright -- Analyst

Great. Thanks for taking my questions, Mike.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Sure, Ed. Thank you.

Operator

Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Hi. Good morning, guys, and thanks for taking the question. I guess more of a follow-up on -- I guess maybe for Adam. I guess given, the lack of black box warning and unique safety profile for UKONIQ, how are doctors, I guess, thinking about incorporating it into their treatment regimens and protocols for relapsed remitting -- sorry not relapse remitting, for relapse refractory follicular and marginal zone patients now?

Adam Waldman -- Chief Commercialization Officer

Yeah, I mean you said it. I mean the fact is, in this patient population, tolerability, convenience play a critical role, and is a top of mind for physicians treating patients with indolent diseases, such as follicular and marginal zone. Docs at least initially have been very -- very impressed with the data in marginal zone and see it as being an option right after first-line therapy.

In follicular, they like the profile. Obviously, there are a few other approved agents there, but they like the profile and see it as being used in the relapse setting -- exactly where and in what order it still remains to be seen. And we're talking to physicians about that, but certainly in the approved indications, they think it's a very appropriate option and that's what we continue to talk to physicians about.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay, that's helpful. And Mike, you went into some detail in terms of the current BTK inhibitors on the market. You mentioned some data that was presented at ASH for 1701. What are you seeing so far in terms of the tolerability profile for 1701 that you think differentiates it from current BTK inhibitors available?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. So, it is early data. But, you look across the -- the, what I call the AEs and interest for BTK inhibitors. They're remarkably low with 1701, it's a 200 mg dose level thus far. Obviously, we need probably some more duration on there, but I think as a start, it looks quite good. To my knowledge, no patients have come off the drug for any dose -- drug-related toxicities. The bleeding risk is -- bleeding and bruising risk is quite low, so -- thus far. I think we're in close to the 15% range versus 50% for the established agents. Again, I think the profile emerging, like I said I do encourage folks to take a look, but right now, it's looking quite good. And we'll update that data as we get more or so. I think there is an emerging profile with activity potentially as good, if not better than what's out there, plus a safety profile that's looking quite attractive.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay, thanks. And last question, I don't want to leave Sean out. You mentioned that there was about $21 million in milestone payments in 2020. What are your anticipated milestone payments for 2021 that you see on the radar?

Sean A. Power -- Chief Financial Officer

Thanks for including me, Matt. Appreciate it. So, we will obviously have some milestones associated with the approval of umbralisib in the first quarter here and potentially some associated with the approval of ublituximab later in the year. So, we haven't fully disclosed what those look like, but qualitatively -- in line with 2020.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

All right. Congrats on the progress, guys and thanks for taking the questions.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Thanks, Matt.

Operator

[Operator Instructions] Your next question comes from the line of Mayank Mamtani with B Riley Securities. Please proceed with your question.

Mayank Mamtani -- B Riley Securities -- Analyst

Hi. Good morning, team. Thanks for taking our question and congrats on the progress. So Adam, from the NCCN category, which category have you been granted for umbralisib? And then, just taking a step back on the follicular variable, as you think about the risk benefit assessment that BMA [Phonetic] have had that led to a little narrower label. How is that kind of different in the community? Like are they kind of secular identical label? Or do you think -- just on the efficacy side, maybe less, but on the tolerability profile, maybe more superior. How do you think about the risk benefit relative to what regulators have with that?

Adam Waldman -- Chief Commercialization Officer

Yeah, Mayank. Thank you. Great question. And yeah, so the first part is the NCCN category. It's a Category 2A in both follicular and marginal zone and it is largely to the label. So, it's a Category 2A to answer your question. And then, as far as the risk benefit profile, I mean, I think right now what we're hearing is physicians see this as a very effective and very well tolerated option for their patients in indolent lymphoma. And I think they see it as a really compelling option in both diseases. As I mentioned, it's distinct from what we've seen from other PI3K inhibitors or what they would expect. The lack of the black box warning does pop up as something that's differentiating. And so, I think they see a very good risk-benefit profile that fits very well into the treatment paradigm for these specific patients.

Mayank Mamtani -- B Riley Securities -- Analyst

Great. And then switching to MS. Have you guys done any -- I know it's -- you guys are still processing the data and it's a lot of volume, but we are starting to see numbers emerge for Ocrevus and Kesimpta also on the number needed to treat. Do you have any early kind of qualitative perspective on what the number needed to treat could be for ublituximab from the MS data that you have?

Adam Waldman -- Chief Commercialization Officer

Sorry Mayank, I didn't hear the -- Mike, I don't know if you heard the question? I couldn't hear it.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. I think it's probably too early to say, Mayank. I think we're -- I think the question Adam was -- we've seen some of the consensus numbers and I think you're asking me what we see as projections for the number of patients that we could expect to see on ublituximab?

Mayank Mamtani -- B Riley Securities -- Analyst

Actually, sorry, the number needed to treat NMD for -- across the different CD20s across these different CD20s. I know there could be some analysis that you could do with the ARR rate you have reported and the relative risk reduction. Have you guys done that yet when comparing it to other CD20s, that's kind of important for the reimbursement?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. I'm not aware that we did that yet, Adam. Has Jamie and her team looked at them at this point, or maybe they're in the process of looking at it?

Adam Waldman -- Chief Commercialization Officer

No. Yeah, no, not yet. No, we're in the midst of doing that right now.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

We'll keep you posted on that one, Mayank.

Mayank Mamtani -- B Riley Securities -- Analyst

Thank you. I believe one of these conferences could have some interesting analysis that can get in. And then Mike, just a question on the earlier stage pipeline. Anything -- any recent activity you've done on the IRAK4 inhibitor? We've obviously not seen much about that in your recent pipeline updates, but anything you could provide there?

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Yeah. So look, we're taking another look at that compound. Originally, we were concerned about the pre-clinical tox profile for the agent, but we have some new folks on board and we're in the process of looking at that right now and letting them evaluate. We're doing some new -- I understand we're going to do some new pre-clinical tests on the compound, otherwise it's -- it is near IND ready. So the new team, including Dr. O'Connor is taking a look at this right now with our other scientific folks on board. So, they will take a look with fresh eyes and some fresh data and they make a determination what they're thinking about the compound. But it is reasonably close to IND ready, and if they feel comfortable moving forward, we can move it forward pretty quickly.

Mayank Mamtani -- B Riley Securities -- Analyst

Great. Thanks for taking my questions team.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

You got it.

Operator

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I'd like to turn the call back to Mr. Michael Weiss for closing remarks.

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Great, thank you. And again, thanks everybody. So I'd like to wrap up today's call once again just reviewing the upcoming key goals and objectives. So at the top of the list, of course, is continue the execution of our commercialization of UKONIQ, umbralisib, and relapsed or refractory marginal and follicular. We're going to work hard to complete the rolling Biologics License Application, the BLA submission for ublituximab in combination with the treatment of patients with CLL that will be including both previously untreated, so treatment-naive and patients for the relapsed or refractory CLL. So what -- we will be seeking a very simple label in the treatment of CLL with that application.

We plan to present final results from the ULTIMATE 1 and 2 Phase 3 trials evaluating ublituximab in RMS. And associated with that, we look forward to submitting a BLA for BLA in RMS targeted for the middle of this year. We're going to continue to advance our early pipeline candidates 1501, 1701, 1801and then of course, we're looking at some of those pre-clinical compounds that we've mentioned in the Q&A. And later in the year, we plan to present updated data from U2 plus venetoclax. We've got our TG-1701 BTK inhibitor that we're presenting some more data on during the course of the year.

And -- hopefully again by year end, we'll potentially have our first data available on our TG-1801, which is our CD47/CD19 bispecific antibody. So, it could shape up to be an exciting year both from the commercial launch perspective, but also from new registration filings, potential approvals, as well as solid compounds coming through the pipeline.

So, on behalf of all of us at TG, I'd like to thank our investigators and their patients, of course, who participate in our trials and trust us, as well as our employees and shareholders for their continued support. Thanks again everyone for joining us and have a great day.

Operator

[Operator Closing Remarks]

Duration: 48 minutes

Call participants:

Jenna Bosco -- Senior Vice President of Corporate Communications

Sean A. Power -- Chief Financial Officer

Michael S. Weiss -- Executive Chairman, President and Chief Executive Officer

Adam Waldman -- Chief Commercialization Officer

Alethia Young -- Cantor Fitzgerald -- Analyst

Roger Song -- Jefferies -- Analyst

Rahul -- JP Morgan -- Analyst

Ed White -- H.C. Wainwright -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Mayank Mamtani -- B Riley Securities -- Analyst

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