TG Therapeutics, Inc. (TGTX) Earnings Call Transcript & Summary

All right. Great. Thanks. Thanks, everyone, for joining in -- for tuning into the JPMorgan Healthcare Conference. I'm Eric Joseph, senior biotech analyst at the firm. And our next presenting company this afternoon is TG Therapeutics. And it's my pleasure to welcome CEO, Mike Weiss, to tell us a little bit about the company. [Operator Instructions] With that, Mike, thanks again for sharing some of your time with us out here.

Yes. Thanks, Eric. I really appreciate it. I want to specifically thank JPMorgan. After 8 years of presenting on a Thursday, when it doesn't matter at all, I got the Tuesday slot. So really appreciate it. So thanks all, and thanks, everyone, for joining us. So on Slide 2, I'll be making some forward-looking statements. I do encourage folks who are interested in TG Therapeutics to review our public disclosure documents available on the Internet. Slide 3. So just in the way of background, the company was founded in 2012 with the goal of developing best treatment options for patients with B-cell diseases. So that's things like chronic lymphocytic leukemia, marginal zone lymphoma, follicular lymphoma as well as on the autoimmune side, things like MS, where we have programs under development. One of the things we've always been keen on is that to get to the best possible treatment options, we always believe that requires combinations of drugs. And so as you can see, we have 5 medicines under development, all of which are designed to potentially be working in unison together, particularly on the cancer side, to orthogonally attack the tumor from -- with multiple mechanisms of action. I'll talk more about that momentarily. Just some numbers, we've conducted 35 clinical trials, 4 have now read out with positive pivotal results this year, 250 employees. And again, we remain committed to patients. And I think that's really extremely important, stay focused on the patients and, of course, good things will happen too for everyone else. So in terms of building out the -- this combination approach, you need a portfolio of compounds. Here, you can see what we have under development in the clinic. We have some preclinical compounds as well. Our lead compounds are umbralisib, our novel PI3K CK1-epsilon inhibitor, for which we've already filed an NDA and actually have target PDUFA dates coming up soon. We'll talk more about that. And ublituximab is our novel glycoengineered anti-CD20 monoclonal antibody. And as you can see in the little stylized hexagon, we refer to that as U2 when we use those drugs together, which we are using in our pivotal study, UNITY-CLL for U2 in combination for CLL. We have positive results from both our CLL study and for ublituximab as a single agent in MS. Additionally, we have 3 compounds in the clinic. I'm not going to spend much time here and probably won't get to today. We've got so much going on with the company that we're going to reserve the portfolio for a future date, we'll cover a little bit of it, but some really interesting compounds within that portfolio, all of which, again, are designed to work together in unison to ideally create the best outcome for patients. So 2020, what a year for TG. For those of you who have watched, the stock has appreciated during the year. One may ask why if you don't know. What I'd like to say is 2020 was a year of data, data, data, right? So UNITY-NHL for which we had results from our marginal zone lymphoma cohort and our follicular lymphoma cohort, and the other data set was UNITY-CLL, which is the U2 combination. UNITY-NHL is umbralisib as a single agent. In UNITY-CLL, we have our combination of umbralisib and ublituximab, U2. That study was also very unique because it enrolled patients that have both frontline or previously untreated and also had patients who had relapsed or were refractory to prior therapy. So that's a very interesting [ set to show ] some of that data. And then just about a month or so ago, we presented our top line from our ULTIMATE I and II MS trial, which is ublituximab as a single agent. That has led us -- as you move to the right or clockwise on this Slide 5. Our NDA is on file for marginal zone and follicular. We initiated a rolling BLA submission for U2 and CLL. We also received Fast Track for U2. So we're hoping that we're going to have a priority review for the CLL application. Those positive events led to our ability to enhance our balance sheet. We're in the best cash position in the 8-year history of this company with $600 million pro forma as of year-end. And with that cash, in addition to all the clinical work we're doing, we've built out our commercial infrastructure. And so TG is launch ready. We've recruited an experienced team. We've built out the commercial organization and we are ready to go. So what does 2020 do for us? It really sets us up for explosive growth from the '21 period forward. So when I think of 2020 as data, data, data, I think of '21 as launch, launch, launch, right, when we think of the 3 launches that could occur in 2021. We've got 2 target PDUFA dates, as I mentioned, for marginal zone lymphoma. That's February 15. So just a month or so away from today. We have follicular lymphoma for -- is -- target date is June 15. So if all goes well, we could be launching umbralisib monotherapy in those 2 indications in the first half of the year. And then moving to your right of the arrow here, we have our U2 combination for relapsed/refractory and frontline CLL. We've commenced our BLA rolling submission. We hope to complete it as early as possible this year. And hopefully, we'll have a target PDUFA date before year-end. And so that is our really nice progression from marginal zone to follicular to CLL. That progression also corresponds with patient numbers for each one of these diseases. So you can see we're really starting to ramp up into this commercial setting for the company. And so CLL is significantly larger than marginal and follicular. And then we move on to relapsing MS, relapsing forms of MS with ublituximab monotherapy, which is the biggest of our opportunities. We had a really exciting readout of the top line results, which we'll talk more about. But we were the first company to achieve in a Phase III trial an annualized relapse rate below 0.10. Again, we'll touch on that in more detail later on in the presentation. But you can see the steady gathering storm, as one might think of, as we push forward in these bigger and bigger indications. And then to cap it off, we do think that as we move into our triple therapies for U2, that we will really round out the market opportunity for CLL. So we'll talk a bit more about that, but we're having some really nice results we presented at ASH for both U2 plus venetoclax and U2 plus our very own BTK 1701. So as the launches roll out and as the market sizes grow for each one, that's how we're going to actually take the presentation today. So I'm going to turn to umbralisib first, and we'll walk through the presentation in the same format. So umbralisib, this is a novel investigational inhibitor, PI3K-delta and CK1-epsilon. To us, this is really a novel class of drugs. I think we've now, after living with this compound for -- in the clinic almost 8 years now, I think, 7.5 or so. From the very beginning, it looked different. The chemical structure is different. It's, pharmacologically, very different from all the other agents that have come across as PI3K inhibitors. This one has a unique kinase profile. And what we've seen clinically is also very different. So in our view, we're really at the place where we see this as a new class of molecules. And we're excited to bring it forward. The one last point on the slide that I'll mention is this is a -- an oral compound, and we're able to dose it once daily, continuous. So let's talk about some of the data. On the right-hand side, you can see the bar graph. So our UNITY-NHL trial is a study of single-agent umbralisib in marginal zone lymphoma, follicular lymphoma and SLL, which is small lymphocytic lymphoma. And so the targets for registration are MZL and FL, but they were all conducted as part of one trial. And we can see basic -- they're basically the primary forms of indolent lymphomas. And what you can see is pretty much across the board. It's approximately half the patients in indolent lymphomas are going to respond to single-agent umbralisib. One point I'd highlight is that we had a really nice response or a complete response rate in patients with marginal zone lymphoma, and as of the report, which was ASH of this year, it was only about 1.5 months ago, none of the complete responders had progressed. And I think we had follow-up in the order of about 2 years on these patients. So pretty impressive depth of response of a single agent. And of course, we continue to drive combinations, combinations. So next up at some point later this year, we'll start talking about U2 in these diseases. But for the moment, it's umbralisib as a monotherapy. Toxicity looked manageable. We'll talk about that momentarily. And again, reiterate PDUFA dates -- target goal dates are coming up soon, February and June. So we talk about the response rates. And like I said, about half the patients with these indolent lymphomas responded to the therapy. And that's important. When we look at clinical trials, you have to pick a bright line test, and 50% reduction in your tumor volume is the test that we use to determine whether these drugs have given a patient response. But in the real world, there's a lot more patients that we think can get benefit from this drug. And again, we're now leaving the clinical world, and we're entering the commercial world. And so I just highlight, again, this is not scientific or clinical, but I highlighted that it's a pretty significant group of patients that had a pretty nice reduction in their tumor mass. And most likely, I don't have all of the details on all these patients. But most likely, had a pretty good course of therapy by using this drug. So if we had about half the patients with -- that are true clinical responses as clinical trials would go, we had another 25% of the patients that had some pretty significant reduction in their disease. So again, when we get out there and patients try this drug, you don't have to be a responder necessarily to want to stay on this drug for some period of time, as long as you're getting benefit. And we think that's an important point to note. So in sort of what really, again, start to see, get us excited -- well, continues to get us excited. We started to get excited on the prior slides. But now we start talking about the safety profile. And I guess, continue -- thought about -- this is a different class of agents. When you start to look at the toxicities of interest that one might expect when you -- if you had a PI3K -- pan-PI3K kinase inhibitor, like the ones that are out there today -- and again, discontinuations due to things like elevation of liver enzymes and diarrhea and the overall -- it's always been about the overall discontinuation rate. And so here, you'll see it's about 15%. And we've been running, on average, 10% to 15%. But to be fair, this is over now an extended median follow-up of 27 months. So that's about a pretty long time to follow up folks, and people will drop off along the way for lots of different reasons. But 15% over 27 months, that's -- to me, that's pretty impressive. We're pretty excited about that. Now on the other side of this screen, again, you're seeing things of -- these particular AEs of special interest that are associated with autoimmune toxicities and rashes, pneumonitis, colitis, all in very low, less than 2%, 1%, less than 2%. And opportunistic infections are actually just associated with pretty much all drugs that target B-cells and have -- associated with treating CLL and follicular, marginal zone. And you look at that number and compare it to what you might get with something like an ibrutinib or acalabrutinib, and this is what you see. So this is really in line with some of the best kinase inhibitors for the treatment of B-cell malignancies. So in terms of patient numbers, again, we started to talk earlier about the -- this progression of indications and the size of the market. So this just gives you a sense of where we see our target market based on what we're hoping for on our label. So marginal zone, it's second line and beyond. And in follicular, it's essentially a third line plus or basically relapsed patients. So you put it all together, and you're talking about somewhere between 10,000 and 12,000 patients annually that will be looking for a treatment that would fit within our target label. So that's not an insignificant number of patients. And for the most part, once you get past first-line therapy in both marginal and follicular, but even more so for marginal, once you get past first-line therapy, there really is no established second line and beyond in marginal zone. And so in essence, patients will get a -- what I would describe as an alphabet soup of potential chemotherapies. They'll get multidrug regimens. Some will get something like R2. Ibrutinib is approved. We think we've got a better profile than what's come before us, and we're excited to get out there and show the value of umbralisib in these patients. So as I mentioned earlier, the team is launch ready. We've got the 2 PDUFA dates, target PDUFA dates listed there. And I don't know that I need to go too far into this. The team has great experience. They've all been involved in hematology launches, some of the biggest brands in the hematology space. We brought people on to the team, years and years of experience and extensive relationships with the cancer centers and the KOLs. And the infrastructure is built and operating. So we've got a really interesting virtual platform that we've been building. We hope COVID is over as soon as possible. But even when it's over, we think the virtual platform is going to have a significant value and being a company -- one of the few companies that's launching into COVID, we think we have some real advantages going forward on how we interface with our partners on the medical side. Our market access team has been on board and engaging top payers for quite some time. Our MSLs have been hired and supporting scientific engagement, and our sales force is on board and being trained today. So with that, I'm going to switch on to ublituximab. So this will now start to set us up for that U2 combination in CLL. And also, we'll start to set up that single agent for MS. So ublituximab, in our view, is not a typical CD20. This is a next-generation CD20. It's been glycoengineered for enhanced potency. I could tell you, in our hands, in analytical assays, this is the most potent anti-CD20 monoclonal antibody. This compound has demonstrated activity in Rituxan-refractory patients. What's also nice about this compound is we give it in a shorter infusion time, both in CLL and in MS. In CLL, we give it in 90 minutes, whereas obinutuzumab is a 3 to 4-hour infusion. And on the MS side, we give it in 1 hour, and ocrelizumab is given in a 2 to 2.5-hour infusion. So some nice convenience advantages as well, both for the patient and for the infusion suites. Over 2,000 patients have been treated with this compound. So we have a lot of safety information that we've gathered over the years, including 3 randomized Phase III trials, all of which have been read out successfully, that have utilized ublituximab. So we were extremely excited in May to notify the world that the study -- UNITY-CLL study had met its primary end point early, and it was stopped at an interim analysis for superior activity and the improvement in PFS, we noted at the time at a P value of 0.001. I think we might have some actual P values on the next slide. That was the top line result. But this study, again, one of the unique aspects of this study is that it was conducted in patients who had both treatment naive as well as relapse/refractory CLL. So assuming that we are successful in getting this drug approved, our expectation, based on the data that we've seen, is that this drug could be approved for both indications, so frontline and relapse, and that would make it the only doublet in CLL to have been approved in both those indications. So that's what we're targeting, and we're going to be working toward that. Our filing has been commenced. Our rolling BLA submission has been commenced, and we're targeting full submission by midyear. So as we mentioned, this is a progression-free survival study. The ITT population was the entire study group. So that was both treatment-naive and relapsed/refractory patients. And you can see a really nice improvement in progression-free survival, with the hazard ratio of 0.54. We've almost doubled the progression-free survival over standard of care chemo immunotherapy. And then if you look at one of the subgroups on Slide 16, we have the treatment-naive population only broken out. And what you can see is in the hazard ratio, we essentially almost more than doubled the progression-free survival. So really nice outcome. For those of you who have the slide in front of you, on Slide 16, what you might notice is that in the green line, which is the U2 arm, you'll see a lot of patients clump together around that 30-month mark. So those are patients more likely than not, I don't have all the details on that, but there's a significant number of those patients that were censored at the time we finished the trial that were still on study. And so those patients, as they continued to march across, assuming that they do continue to march across, could change the shape of that curve and could change the U2 median. So we're keeping our eyes out for that. We think that it's possible that, that U2 median pushes out. And my guess is without having talk to anyone else in the company, my guess is that by next ASH, we might be in a position to take another look at that curve and update the PFS curve. So some potentially new things to come. But overall, really nice outcome, U2 dramatically increasing progression-free survival over standard chemoimmunotherapy. And again, safety, very critical part of any treatment, particularly again, marginal zone, follicular and CLL. These are chronic diseases where you don't want to replace the toxicity of the disease with the toxicity of a drug. So safety profile is critical. We feel like that U2 combination does a really nice job in balancing the risk/benefit with the combination. But the other thing that's really interesting about this particular data set on the slide, so we've not only just compared it against the standard of care, but we've looked at U2 in the treatment-naive patients and U2 in previously treated patients. And the reason why we did that is because when we started working with this compound, one of the places where most KOLs said don't try is don't try to treat a patient with frontline CLL because these drugs can be really dangerous in that patient population. Others had tried it, a drug called idelalisib did a frontline trial, and they had very aggressive autoimmune-related toxicities in that patient population, which led to a label adjustment that recommended they not be used in frontline patients. So when you look at the toxicity profile between naive and previously treated, and they basically look the same, it really is a testament that this is, again, to my point, this is a different class of drugs. We believe it -- again, it's just -- it's a different molecule, and this is one of the tests. If you were going to try to test to see it, say you were different, this is the group of patients you should look at. And if you weren't different -- if you weren't the same in the safety profile, then you wouldn't be different in terms of the molecule and its mechanism. So very excited about these results. And so CLL is, again, as I mentioned, this progression, this march, marginal zone, follicular, CLL to MS. This is a huge problem. There's a lot of patients living with CLL. These recent estimates are about 185 million -- 85 million -- 185,000 Americans living with CLL. And it's about 40,000, give or take, patients that will come in looking for a new treatment every year. So not everyone is being treated that's living with it. Some are being treated fine, and some are waiting to be treated. So when we think about the label for U2, our hope is that it will be a very broad label that will -- say, for the treatment of CLL. But within that broad label, our focus is really going to be on the unmet needs for these patients, right? So there are good therapies out there. BTK inhibitors are good treatments, and venetoclax is a good treatment, particularly for patients that are being treated in academic centers. But not everyone is being well served, and that's where U2 comes into play. So there's a lot of patients, on Slide 18, where they're just not appropriate or good candidates for BTK therapy. We estimate there's about 20% of patients that are naive to BTK, and they're just poor candidates for therapy: cardiovascular risk being the largest of those subgroups; patients with bleeding risk, patients on something like a Coumadin are at risk for bleeding events on a BTK inhibitor. So we think there's an opportunity to help those patients out with U2. And then there's a really large group of patients who have already seen a BTK, right? So this has been out there for a while. Patients have come on and come off of BTK. And what's available to them is very limited. So over 100,000 patients have been treated with BTK inhibitors. They will be coming back into the system over time. In a real-world setting study, which I quote here, there's about a 40% discontinuation rate for intolerability or progression at a median of 17 months. So there's a need for new treatments in CLL. We think U2 does a really nice job fitting into those unmet medical needs. And then in the future, we think to move beyond those unmet medical needs, we see U2 as a partner compound in combination with other standard of care treatments. So U2 plus venetoclax and U2 plus BTK are 2 areas of great interest to us, and we have studies underway. I'm going to talk briefly about those now. So let's talk about U2 plus venetoclax. So venetoclax is a really good drug. It's particularly good when used in combination with something else. So on its own, it's good but certainly better in combination. We would like to make the argument that we believe that U2 plus venetoclax is the best partner for venetoclax. And we have some data to support that now, which is what's here on Slide 19. So at ASH this year, so just 1.5 months ago, we presented Phase I data and so just to walk through this briefly, cycle 3, on the left-hand side, you can see U2 was used just as U2, right? So there's no venetoclax yet. And what you can see is just under 80% of the patients responded to U2 alone. That's pretty consistent with the data we have from UNITY-CLL. So that's a pretty consistent rate. Your relapsed patient, about 80% are going to respond, a little bit less, but in that range. And then we introduced venetoclax on top of U2. And we go on for 9 additional months in this study. So that total time is about 12 months when we get there. So first thing to know is that cycle 7, the first time we'd look again at the patients' radiographic scans, 100% of the patients are now responder. We don't check bone marrows there, so we don't know if they're a CR or a PR. So we just include them all as a PR at that time. Then at cycle 12, we take bone marrow, we'd look for CR, and we'd look for undetectable MRD. And what's pretty remarkable, the CR rate of 41% is very high. For relapsed/refractory CLL, that's some of the best CR rates you're going to see. But really drilling down into the undetectable MRD, 77% of these 27 patients had undetectable MRD, which, again, I think to date, that is the best-reported data on MRD-negative in the bone marrow of any combination or any drug in CLL. So really off to a great start. We're treating a lot more patients. 27 is not a final answer. And so great start, let's do more, and let's see where we end up. In the box to the right of the table, I just will note parenthetically that after cycle 3, when we just had U2 on board for 3 cycles, that's only 3 cycles of U2, we give U2 up to -- until patients progress. But after just 3 cycles of therapy, 64% of the patients who are BTK refractory -- let me say that again, 64% of the patients who are BTK refractory responded to U2 alone before venetoclax. Clearly, afterwards, 100% of them responded because we have 100% response rate. And that's BTK refractory, of all BTK pretreated patients is about 75%. So again, really nice activity of U2 alone, but even better when you mix it with venetoclax. Our ULTRA-V Phase II study on the right-hand side of Slide 19 is basically fully enrolled, and the primary end point will be at 12 months. So we'll be talking next year potentially about that data around this time. Finally, let's talk about BTK combinations with umbralisib and with U2. So in CLL, which is the first column on Slide 20, the first column with numbers in it on Slide 20, you can see if you take umbralisib and you put it with ibrutinib alone, you got a very nice high response rate, nice CR rates. And as you go down, you see when we put U2 with ibrutinib, 100% response rate, high CR rates. And we only have a little bit of data right now. So it's there. But with our own 1701, the pattern continues. So if you just put together U2 plus BTK, we've treated 25 patients, all of them responded. Will that continue forever? No. There's always going to be a patient that doesn't respond. But what you can see is you put these combinations together, nearly every patient will respond to therapy. And you can see the CR rates should go up as well, which is very important. And I'll throw in a little pitch for marginal zone lymphoma. Again, it's not as big as CLL, but we think we can really do some great things for patients with marginal zone lymphoma with a U2 plus BTK combination. You can see there, again, only 5 patients, but all 5 responded. So in the future, we see this as a really nice opportunity for U2, both in combination with venetoclax and in combination with BTK. Okay. So now some may say that I saved the best for last, and that may be true. I can certainly say that I saved the largest market for last, that's for sure. So let's talk about ublituximab in the treatment of relapsing forms of MS. So we were -- when we started the study, we were certainly -- we were -- we just wanted to be positive. I guess step one, we just wanted to be positive. And we did have in the back [ of it ], hoping we can get below 0.10 annualized relapse rate. I will tell you that we -- not only were we excited to have gone below 0.10, but when we showed it to our KOLs, they all were extremely excited. We had a call with investors with one of our KOLs, actually 2 of our KOLs, both of which agreed, one of which unscripted, off-the-cuff said, this is great. This is unprecedented. This is the first time that any study has ever read out below 0.1. This is a barrier that the MS community has -- trying to -- has been trying to break for years, and he likened it to Chuck Yeager breaking the sound barrier and then other conversations to Roger Bannister breaking the 4-minute mile. This is something that is very important to folks to get below that 0.1. We're the first ones to do it, with a very highly statistically significant result. And on a -- that was an absolute basis. On a relative basis also, really dramatic improvements, approximately 50% and 60% improvements over teriflunomide, which is an active drug. In fact, the branded form of that sells nearly $2 billion in sales. So teriflunomide is an active comparator arm for which we had a very nice significant advantage over. So the full data, we're expecting -- or targeting to present in the first half is just the top line. We still need to finish cleaning up that study and getting it ready for both filing, which we're hoping to do by mid-2021 and similarly, around the same time frame, getting out a presentation. So we don't have all the data yet. So on Slide 22, I'm going to go back to our Phase II data. The first thing I'll say about the Phase II is we also had an annualized relapse rate that was below 0.10 with 0.07. And I can tell you that there were a lot of people that were super excited about that. And others were so much skeptical saying, well, maybe it's just a fluke, and it's not Phase I -- Phase II studies, 49 patients, 48 patients. Let's see if it's reproducible in a larger number. So that's really nice to see that, that wasn't a fluke and that we were able to go below 0.10. So does that give me some comfort that our secondaries will similarly come along with that? Gives me comfort. There's no guarantees. But what we can see in the Phase II is really remarkable effects on T1 Gd-enhancing lesions particularly. So these are sort of a hallmark classic sign of MS, and we eliminated them completely, 100% reduction in T1 Gd-enhancing lesions. Also really nice results on clinical or confirmed disability progression. [ NEDA ], which is a compilation of clinical radiographic and disability progression, also very high in the Phase II. So we're keeping our fingers crossed. Hopefully, the pull-through from that ARR will continue. And then the last piece that we don't have in addition to the secondary is the safety information, which is also something that obviously will be of importance to treating physicians. We had a good manageable safety profile in the Phase II. We've had the drug in lots of patients. So our expectation is that the safety profile should look like a CD20. And if it does, we're feeling very good about the overall profile of this compound. So as I mentioned again, from that progression, MS is the largest patient population that we are addressing, about 1 million Americans living with MS. I think about 400,000 are being treated. The market is expected to grow to $25 billion to $30 billion over the next several years. The CD20 class alone is expected to grow to about $10 billion, which would represent a little over 1/3 of the overall MS market. And what you can see on the left side, today, you can see the -- only CD20 has its market share. But across the other classes, what you see is that there are multiple billion-dollar franchises, multibillion-dollar franchises across other classes. And I would expect that over time, when we look at the CD20 class in 3 or 5 years, there's going to be 3 drugs. And it's going to look a lot like that T cell targeted oral class on Slide 23, where you've got split between 3 major players, and they're all sharing in approximately a $10 billion market opportunity. So we're feeling extremely good. We think our profile looks very good. We'll talk about that as a summary. But the last thing I'll add in terms of the physician side of this thing, it's somewhat remarkable that about 80% of the patients with MS in the U.S. are treated by about 4,000 to 5,000 physicians. That's a highly concentrated group. So this is something that we feel really confident that we can -- with our team and the team that we're going to build, can really impact MS in the marketplace. So what's our value proposition for ublituximab in MS? So on the clinical side, we are the first ones to demonstrate an annualized relapse rate below 0.10. So we certainly have bragging rights there, and we can make the case that this is the most active CD20. We have the convenience of a 1-hour fusion. I mentioned earlier, we can deliver this drug in 1-hour fusion every 6 months. It fits in really nicely with how MS patients go and see their physicians. So 1 hour, every 6 months, we think, is a really nice profile. And in terms of access, insurance and pricing, we've said this in every forum that we would like to explore the ability to strategically price this drug in a way that optimizes patient access and limits or eliminates [ step-throughs ] or prior authorizations for other treatments. If we can successfully do that with price, we will do that with price. We think it's worth it. We think it's a value to the patients and the system. So we know we're going into a competitive area. We think we're going in with a really exciting profile. We'd like to be able to say, I mean, if all goes well, we'd like to be able to say, look, we believe we have the most active, most convenient, best-priced product. We think with that kind of a profile, we're going to do quite well even in a competitive market. And as I showed on the prior slide, it's a big market, and there's plenty of room for folks to share as it has previously in other markets. So with that, I'm going to leave our projected milestones up on the screen, Slide 25. So we've got a big year as I mentioned. 2021 is about launches. So data, data, data in '20, '21 is launch, launch, launch and then some commercial and clinical updates. But I do thank everyone for your time and attention.

Thanks, Mike, for your presentation and overview. Unfortunately, I think we're coming to the top of the presentation, top of the allotted time. Maybe let me just actually ask one quick question. Given that 2021 is all about launch, launch, launch and we've seen kind of a mix of how [indiscernible] have gone in this pandemic climate, what capabilities are you bringing to the umbralisib launch that you think are going to maximize the uptake, the effort, assuming approval in the first half of -- in the next -- yes, sorry, in the first half of this year?

Yes. Thanks, Eric. So we've got a combination of a differentiated compound. We think what we're bringing to the table versus what others have previously brought to the table is really differentiated. And so that's going to stand out. And we've got a really talented, experienced team. It's all about education. Our goal is the more you know, the more you'll be interested in using umbralisib. So our goal is to educate, educate, educate. And I think we've got a compound, again, when you look at the profile, both the activity level and the tolerability profile. And you know this, Eric, from many, many years ago, we were talking about tolerability, and everyone else only wanted to talk about activity. And we kept talking about tolerability, and they thought we were crazy. So I think now is the time for that to pay off for us.

All right. Unfortunately, I think we have to leave it here for the sake of time. But Mike, I want to thank you again for your presentation. And thanks, everybody, for tuning in to the webcast this afternoon. Everybody, have a great day.

Thanks, Eric.