TG Therapeutics Inc (TGTX) 2020 Q4 法說會逐字稿

Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-end 2020 Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Please go ahead.

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.

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 noncash 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 noncash 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 noncash 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 CMC expenses as compared to the prior period. The GAAP net loss for the 2020 year-end, inclusive of noncash items, was $279.4 million or $2.42 per share compared to a net loss of $172.9 million or $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 expectation. 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 will now turn the call over to Mike Weiss, our Executive Chairman and CEO.

Great. Thank you, Sean, and thank you, Jenna, and 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 whether relapsed or refractory marginal zone lymphoma who have received at least 1 prior anti-CD20 base regimen and adults with relapsed or refractory follicular lymphoma, who have received at least 3 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, 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 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 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 top line results of our 2 Phase III studies of ublituximab in 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 the KOLs as breaking an important barrier, one that has not been achieved before in any previous MS Phase III trial.

As you can imagine, we are very excited about these top line results, and we are 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 an ubli-RMS 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 (inaudible), 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 II results of ublituximab in multiple sclerosis, in the Multiple Sclerosis Journal; the final Phase II data evaluating umbralisib in patients with CLL who are intolerant to prior BTK or PI3K inhibitors, in the general blood; the final results from the Phase III GENUINE trial evaluating ublituximab plus ibrutinib in patients with relapsed or refractory high-risk CLL was published in the Lancet Hematology; and finally, on the preclinical side, data described in 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 strengthened 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?

Yes. 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 4 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 the 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 expert speakers to help educate the community on UKONIQ and have 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. 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 in 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.

(Operator Instructions) Your first question comes from the line of Alethia Young with Cantor Fitzgerald.

Congrats on the progress over 2020. It really did play out the way you kind of said it, Mike. I have 2 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 a 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 combinations, how are you guys thinking about time lines around maybe starting on other studies, maybe in like PPMs or in other indications there?

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

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

Yes. That's okay. Yes. Thanks, Alethia, for the question. Yes. We -- obviously, we knew that there was an overhang amongst 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.

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 ublituximab to ubli. And we're also continuing to evaluate some other indications. I'd say our target is to have at least 1 additional study open before year-end, and we'll keep you posted.

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

Great. 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?

Yes. Thanks for the question. So in future calls, we'll obviously report on net revenue. In addition, we'll plan on sharing both quantitative and qualitative insights and metrics to demonstrate our progress with our strategy and execution and end market performance where we see appropriate. I guess some examples maybe -- and I don't -- we're still working through exactly how we're going to do this. But examples maybe 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 continue to work on it. And -- but hopefully, that answers your question.

Yes. That's helpful. Okay. And next question maybe for Adam or Mike. We understand the overhang, just following the Alethia's question for the PI3K class, but since you have seen this kind of differentiation and the part of feedback from the -- from doctors. And just curious your expectations for the sales ramp up, you're expecting some quick ramp-up because the enthusiasm from the clinicians you have been talking with because we know a lot of the community doc already use their UKONIQ during the UNITY-NHL or earlier clinical studies?

Yes. I'll jump in and you can add on top of that, Adam. I mean, I think we're still -- from where I sit 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. I don't want people to assume that 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 zone follicular are really great indications for us to start with. But obviously, we're expecting the ramp to really start to go into play when we start launching into CLL. Adam, you could add on top of that.

Yes. I agree. I mean, we're enthusiastic about the reaction from physicians who are definitely seeing a differentiated profile, 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, 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.

Your next question comes from the line of Eric Joseph with JPMorgan.

This is Rahul on for Eric. There's 2 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 the U2 relative to Calquence? And secondly, what should we think about the earliest data readouts from the ULTRA-V; trial? Should we expect a top line readout with response rates or something more mature like a duration of response in PFS?

Sure. So I'll take a crack at the first question and a crack the second one and Adam may chime in. So Calquence versus ibrutinib, again, it's -- we're -- it's sort of the third hand -- we're talking about drugs that aren't ours. But my impression is that there are some folks who believe that 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 -- I'll doublecheck those numbers. But we 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; that 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 for 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. We'll, of course, over time, follow patients not only for duration of response but for question for survival and overall survival. But the endpoints for this trial -- the primary endpoint, 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 I 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 there. 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 II portion, the Phase III portion of that trial will open and then we will be looking for a PFS endpoint that would be usable for full approval. Hopefully, that helps, Rahul.

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

So just on the CLL submission. I think Sean had mentioned launches for CLL and MS in 2022. 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?

Yes. So we're hopeful that we'll receive prior review. We do have fast-track designation, which doesn't fully entitle one to priority review, but we do think that puts us on the right track toward a priority review. So we'll be pushing forward in and at and asking for certainly -- asking for a private 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 price for umbralisib. We'll soon, at some point, price ublituximab. But ideally, when we put the 2 pieces together and using whatever discounts makes sense. We'll be able to put out a price that strategically puts us in a really nice competitive location versus some other doublets that are out there in CLL.

And just a question on MS launch. Again, thinking of pricing, so you're launching an MS similar launch in oncology as well. How should we be thinking about pricing there? And 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?

Yes. 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 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 this interesting measure and sort of gets people thinking about the re-halting of the progression of these diseases and the disease process.

So assuming that our data and data from the other the CD20s continue to support the fact that if you get them on a CD20 early, you can really arrest the disease process. That's an exciting opportunity. And so again, we think that we'll be moving earlier and earlier. And our positioning within the class of 3 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 1-hour infusion every 6 months is a very convenient and fits within the practice of MS physicians who like to see their patients at least every 6 months. Getting them in with 1 hour fusion 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 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 help 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.

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

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

Yes. 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 relapsed setting, exactly where and what order is 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.

Okay. That's helpful. And Mike, you went into some detail in terms of the current BTK inhibitors on the market. And 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?

Yes. So it is early data, but when you look across the -- what I call the AEs and interest for BTK inhibitors, they are remarkably low with 1701 at the 200-milligram dose level thus far. Obviously, we need probably some more duration on there, but I think as a start, 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, thus far. I think we're close to the 15% range versus 50% for the established agents. Again, I think the profile emerge, and 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. So I think there's 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.

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

Thanks for including me, Matt. I 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, I would say, in line with 2020.

(Operator Instructions) Your next question comes from the line of Mayank Mamtani with B. Riley Securities.

Congrats on the progress. So Adam, on the NCCN category, which category have you been granted for umbralisib? And then just taking a step back on the follicular label, as you think about the risk-benefit assessment that (inaudible) have had that led to a little narrower label, how is that kind of different in the community? Like, are they kind of strictly abiding to the label? Or do you think just on the efficacy side, maybe less, but on the tolerability profile may be more superior? How do you think about the risk-benefit relative to what regulators may have looked at?

Yes. Mike, thank you. Great question. And yes, 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 physician see this as a very effective and very well-tolerated option for their patients in lymphoma. And I think they see it as a really compelling option in both diseases. As I mentioned, it's distinct from what they'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.

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 limited treat could be for ublituximab from the MS data that you have?

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

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

Actually, sorry, the number needed to treat NMD for -- 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 reimbursement?

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

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

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

Got it. I believe one of these conferences could have some interesting analysis (inaudible). 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?

Yes. So look, we're taking another look at that compound. Originally, we were concerned about the preclinical 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 preclinical tests on the cost side.

Otherwise, it is near IND ready. So if the new team, including Dr. [Arnold Connor] take 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 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.

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.

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, in relapsed or refractory marginal zone and follicular. We're going to work hard to complete the rolling biologics license application, the BLA submission, ublituximab in combination with umbralisib for 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 we will be seeking a very simple (inaudible) of the treatment of CLL with that application. We plan to present final results from the ULTIMATE I and II Phase III trials evaluating ublituximab in RMS. And associated with that, we look forward to submitting a delay for ubli in RMS, targeted for the middle of this year. We're going to continue to advance our early pipeline candidates, 1501, 1701 and 1801. And then, of course, we're looking at some of those preclinical compounds that were 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-HN1], 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 follow-up 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.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.