TG Therapeutics Inc. (NASDAQ:TGTX) Q4 2020 Earnings Conference Call March 2, 2020 8:30 AM ET
Jenna Bosco – Senior Vice President of Corporate Communications
Sean Power – Chief Financial Officer
Michael Weiss – Executive Chairman and Chief Executive Officer
Adam Waldman – Chief Commercialization Officer
Conference Call Participants
Alethia Young – Cantor Fitzgerald
Roger Song – Jefferies
Ed White – HC Wainwright
Matt Kaplan – Ladenburg Thalmann
Mayank Mamtani – B. Riley Securities
Greetings and welcome to the TG Therapeutics Fourth Quarter and Year End 2020 Conference Call. At this time, all participants are in a listen-only mode. A 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 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 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 that 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 CNC 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 and 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.
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, 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 2021 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 achieve the primary endpoint of improving progression-free survival over standard of care chemoimmunotherapy and those results were consistent for patients with treatment naïve CLL, as well as relapsed or refractory CLL. In addition, there was a significant improvement in overall response rate, the secondary end point.
Finally at ASH, we also present the 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 TG-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 milligrams 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 three – of our two Phase 3 studies of 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. Our 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 top line 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. That will be used to support in 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 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 preclinical 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 stress 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. But that is 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 were 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 the 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.
This is 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 one. 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 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.
Drug is now fully available than 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 will 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.
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.
Hey, guys. Congrats another 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 more about kind of how the market was a little, it might’ve been a little bit hesitant, 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 the totality, but do you sense that – people are more open-minded around kind of the safety profile that UKONIQ provide. And then the second question is just in multiple sclerosis there in that with the U2 combinations. How are you guys thinking about timelines around maybe starting on other studies, maybe in like PPMS [ph] or another indication there. Thanks.
Hey, Mike, you want me to start with the first one?
Yes, please. Go ahead, Adam.
Yes. That’s okay. Yes. Thanks. 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 in 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 [indiscernible] to ubli. And we’re also continuing to evaluate some other indications. I’d say, our target is to have at least one additional study open before year end. And we’ll keep you posted.
Great. Thank you.
Your next question comes from the line of Roger Song with Jefferies. Please proceed with your question.
Great. Thank you. Congrats on the progress. Maybe one question for Adam, since this is the early to the launch, and so tonight 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 will 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 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 quality of 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. Helpful. Thank you. Okay. And next question may be for Adam or Mike. We understand that we’ll the hand just follow on Alethia’s question. For the PI3K class, but since you have seen this kind of differentiation and the part of feedback from doctors. And just curious your expectations 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 dock already used UKONIQ during the UNITY-NHL 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 the 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…
Yes, 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.
Got it. Yes, that’s in the – yes, so good to have some color around expectation. Thank you, Mike and Adam. That’s it from me. Congrats again.
Great. Thanks, Roger.
Your next question comes from the line of Eric Joseph with JPMorgan. Please proceed with your question.
Hi, good morning. This is Rahul on for Eric. Thanks for taking the questions. Just from us. Firstly, can you talk about how physicians view the comparative safety profile of Calkins versus Imbruvica. And what’s the anticipated competitive dynamic of U2 relative to Calkins. And secondly, should we think about the earliest data readouts from the ULTRA-V trial? Should we expect top end 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 I crack the second one and Adam chime in. So Calkins versus ibrutinib, again, it’s sort of third hand, where we’re talking about drugs that aren’t ours. But my impression is that there are some folks who believe the Calkins 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 in tolerant that go on Calkins, 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 Calkins, 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 Calkins and ibrutinib. So U2 really fits in nicely into patients who either have seen a BTK inhibitor and I’ve 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 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 or 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 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?
Your next question comes from the line of Ed White from HC Wainwright. Please proceed with your question.
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 potential priority review, if that’s possible in a 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 a Fast Track designation, which doesn’t fully entitle one to priority review, but we do think 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’re – 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 will soon at some point price ublituximab. But ideally when we put the two pieces together and using whatever discounts make 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.
Thanks, Mike. And just a question on MS launch, again, thinking of pricing. So you’re launching an MS and we’ll 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 today, where’s 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 – we’re kind of excited to see our meta 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 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 really arrest the disease process. That’s an exciting opportunity.
And so again, we think that we’ll be moving 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 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 and 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 in for us to gain market share. And we do things that’s as it stands right now, certainly based on the annualized relapse rate data that we have certainly 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.
Great. Thanks for taking my questions, Mike.
Sure, Ed. Thank you.
Your next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hi. Good morning, guys and thanks for taking the question. I guess, more of a follow-up, I guess, maybe for Adam. I guess, given the lack of black box warning and the unique 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 relapsed/refractory follicular and marginal zone patients now.
Yes. I mean, you said it. 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 liked the profile. Obviously, there are a few other approved agents there, but they liked the profile and see it as being used in the relapse setting, exactly where and in 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 you look across, the – what I call the AEs and interest for BTK inhibitors. They’re remarkably low with the 1701, it’s 200 milligram dose levels thus far. Obviously, we need probably some more duration on there. But I think as a start it looks quite good. And 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 in close to the 15% range versus 50% for the established agents. Again, I think the profile of 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. 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. Thanks. And last question, don’t want to leave Sean out. You mentioned that there were about $21 million in milestone payments in 2020. What are your milestone payments for 2021 that you see out on the radar?
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, I would take in line with 2020.
Great. Congrats on the progress guys. And thanks for taking questions.
[Operator Instructions] Your next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.
I do mind being thanks for taking our questions and 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 variable, as you think about the risk benefit assessment that BMO have had that led to that does it matter what label, how is that kind of different in the community like or 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?
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 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 they’ve seen from other PI3K inhibitors or what they would expect, the lack of the black box warning does popup 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 you guys are say processing the data and it’s a lot of volume, but we’re starting to see numbers to merge for OCREVUS and gets MD out so on the number needed to treat. Do you have any early kind of qualitative perspective on what the number that you do treat could be for ublituximab from the MS data that you have?
Sorry, Mayank, I didn’t hear the – Mike, I don’t know if you heard the question.
Yes. It is 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 the different CD20. I know that there could do some analysis that you could do with the data that we have reported and the relative risk reduction. And you guys done that yet, when comparing it to other CD20, it’s kind of important for the reimbursement?
Yes. I’m not aware that we did that yet Adam, as Jamie and her team looked at them at this point, or maybe they’re in the process of looking at?
Yes. No, not yet. We’re in the midst of doing that right now. We’ll keep you posted on that one.
Thank you. I believe one of these conferences could have some interesting analysis that can get in. And then Mike, just question on the earlier stage pipeline, any recent activity you’ve done on the IRAK4 inhibitor, you’ve obviously 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 it.
We’re doing some new understandings. We’re going to do some new preclinical tests on the compound. Otherwise it’s near IND ready. So if the new team, including Dr. O’connor taking a look at this right now with our other scientific folks on board. So they’ll take a look with fresh eyes and some fresh data and make a determination what they’re thinking about with the compound, but it is reasonably close to IND ready and if they feel comfortable moving forward, we can move forward pretty quickly.
Great. Thanks for taking my question team.
You got it.
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 continuing the execution of our commercialization of UKONIQ, umbralisib in relapsed/refractory, marginal zone and follicular. We’re going to work hard to complete the rolling Biologics License Application, the BLA submission of ublituximab in combination with the treatment of patients with CLL that will be including both previously untreated, its treatment naive and patients for the relapsed/refractory CLL. So 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 I & II Phase 3 trials, evaluating Ublituximab in RMS and associated with that we look forward to submitting a BLA for ubli in RMS targeted for the middle of this year.
We’re going to continue to advance our early pipeline candidates TG-1501, TG-1701, TG-1801. And then of course, we’re looking at some of the pre-clinical compounds that were mentioned in the Q&A. And later in the year, we plan to the present updated data from U2 plus Venetoclax. We’ve got our TG-1701 BTK inhibitor that will presenting some more data on during the course of the year. And hopefully again by year end, we’ll potentially have our first date available on our TG-1801, which is our CD47, CD19 bi-specific antibody.
So 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 that’s all of 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.