Tg Therapeutics, Inc. Q1 FY2021 Earnings Call

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

Thank you. Welcome everyone. And thanks for joining us this morning. I’m Jenna Bosco and with me today to discuss the first quarter 2021 financial results and provide a business update are Mike Weiss, our Executive Chairman and Chief Executive Officer; Adam Waldman, our Chief Commercialization Officer; and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate development as well as an update on our current pivotal programs and key goals for 2021. Adam will provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics’ operations include various risk factors that can be found in our filings with the Securities and Exchange Commission including our most recent quarterly report on Form 10-Q. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on TG’s website, www.tgtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be on a listen-only mode. Now, I’d like to turn the call over to Mike Weiss, our CEO.

Thank you, Jenna. And thanks everyone for joining us this morning. With the recent accelerated approval of UKONIQ for the treatment of relapsed or refractory marginal zone lymphoma and follicular lymphoma, TG has transitioned into a fully integrated commercial organization. We are extremely pleased to now have UKONIQ, the first and only dual inhibitor of PI3K-delta and CK1-epsilon, available to patients. We see the approval of UKONIQ as the first step in our broader mission of developing novel treatments for patients with B-cell diseases. With successful Phase 3 studies in chronic lymphocytic leukemia (CLL) and multiple sclerosis (MS) already completed and reported, we see the potential to positively impact a significantly larger group of patients on the horizon. Beyond that, our pipeline has the potential to deliver novel combinations built upon a foundation of UKONIQ and ublituximab, our U2 combination, that can further enhance outcomes for patients with B-cell diseases. Before I hand over to our Chief Commercialization Officer, Adam Waldman, to discuss the UKONIQ launch and preparations for the potential CLL and MS launches, I wanted to review some of our recent accomplishments as well as the current status of our ongoing programs. First and foremost, as I mentioned at the outset of these prepared remarks, in February, the FDA granted accelerated approval of UKONIQ for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen, and for adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. This approval was primarily based on the results of the UKONIQ monotherapy cohorts of the UNITY-NHL Phase 2b trial. The approval came shortly after the final results from the trial were presented at the American Society of Hematology Annual Meeting (ASH) in December 2020. Also, within a month of approval these results were published in the Journal of Clinical Oncology. The commercial team has been hard at work educating potential prescribers of UKONIQ and building a strong foundation which we believe will continue to translate into adoption of UKONIQ and position us well for the planned CLL launch potentially later this year or early next year. On that note, as most of you know, we presented positive results from the UNITY-CLL Phase 3 trial at the ASH Annual Meeting in December. More recently, at the end of March, we announced the completion of a rolling submission of a Biologics License Application, referred to as a BLA, to the U.S. Food and Drug Administration requesting approval of ublituximab, our investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQ. The combination, as many of you know, is referred to as U2, as a treatment for patients with chronic lymphocytic leukemia. This BLA submission was based primarily on the results of the UNITY-CLL trial, which was conducted under special protocol assessment. As a reminder, the FDA previously granted Fast Track designation to the U2 combination for the treatment of adult patients with CLL and orphan drug designation for the U2 combination for the treatment of CLL. The next step is we expect to hear from the FDA later this month on whether they have accepted the submission for filing. With approximately 185,000 Americans living with CLL and approximately 40,000 patients seeking treatment annually, CLL remains an incurable disease and represents a large patient population where we believe U2 will provide a needed treatment option for these patients. Now, I'd like to turn to our MS program, where our BLA submission is slated for the third quarter of this year. That BLA will be supported by the positive results from our ULTIMATE I and II Phase 3 trials, evaluating ublituximab in relapsing forms of MS, which were presented during the AAN conference last month. Both studies met their primary endpoint with ublituximab treatment, demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period with a P-value of less than 0.005 in both trials, compared to teriflunomide. Ublituximab treatment resulted in an ARR of 0.076 in ULTIMATE I and 0.091 in ULTIMATE II. For those who were on the call with the experts who are speaking later today, they were very excited to see that those ARR numbers were below 0.10, which had never occurred before in a Phase 3 trial. So we are really excited about those results. We also hit key secondary MRI endpoints, including statistically significant reductions in both T1 Gd-enhancing lesions as well as T2 lesions. Ublituximab also reduced disability progression and increased the rate of disability improvement as compared to teriflunomide; however, the former was not statistically significant. In addition to the presentation at AAN, we hosted a call with leading neurologists to review this data, and the replay of that call is available on our website. I do encourage folks who are interested in TG to have a listen to that call. The doctors on the call were very enthusiastic about the profile of ublituximab and its potential in the treatment of MS. For our part, we are extremely pleased with the results from ULTIMATE I and II, and believe these data showcase the potential of ublituximab to provide a highly efficacious treatment option with a generally well-tolerated safety profile. If approved, ublituximab will be the only CD20 therapy offered in a convenient one-hour infusion every six months, of course following the first infusion, which treating physicians have shared is an important benefit for them and their patients. As a reminder, these trials were also conducted under special protocol assessment with the FDA, and as noted earlier, we are targeting a BLA submission for ublituximab to treat patients with relapsing forms of multiple sclerosis in the third quarter of this year. The last topic I want to cover before I turn the call over to Adam is our U2 plus venetoclax program and our U2 plus TG-1701 program. As a reminder, TG-1701 is our internal BTK inhibitor. We view both of these programs as an important part of the growth strategy for U2 in CLL. For the U2 plus venetoclax program, we have the Phase 1 study led by Dr. Paul Barr, Professor of Medicine and Director of the Clinical Trials Office for the Wilmot Cancer Center in Rochester, New York. Preliminary results from the first 27 patients in this study who completed 12 cycles of fixed-duration therapy were presented at ASH this past December. In those patients, there was a 100% overall response rate, and greater than 75% of those patients achieved undetectable minimal residual disease in the bone marrow. To my knowledge, that is the best reported rate of undetectable minimal residual disease in the bone marrow to date in patients with relapsed refractory CLL. Later this year, we should have almost twice as many patients to report on through 12 cycles of treatment. Now that Phase 1 set the foundation for the Ultra-V Phase 2/3 trial, which is evaluating the combination of U2 plus venetoclax in patients with both treatment-naive CLL as well as relapsed or refractory CLL. The Phase 2 portion of the Ultra-V trial completed enrollment with approximately 165 patients being enrolled in just 16 months. The Phase 3 portion is now open to enrollment, and there's a multicenter randomized trial comparing U2 plus venetoclax to an active control arm of U2. This trial is being led by Dr. Richard Furman, who is the Director of CLL Research at Weill Cornell Medicine. We are excited about this combination and believe it can potentially offer patients a very active treatment that is of limited duration. Finally, I mentioned that our BTK inhibitor TG-1701 continues to impress us. We reported preliminary data at ASH and we'll provide another update in the coming weeks at ASCO. Our goal is to explore the potential combination of UKONIQ and U2 with TG-1701 to offer the benefits of triple inhibition of BTK, PI3K, and CK1-epsilon, which would be the first of its kind. The aim is to put them together while also dialing down the known toxicities of each of those classes. Again, this would be a very novel first-in-class approach. As you can see, significant progress has been made across all of our pivotal programs, setting us up for an exciting remainder of 2021 and hopefully an even more impactful 2022 with the potential of expanding our commercialization efforts into CLL and MS. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Waldman, to share some highlights from our early commercialization efforts of UKONIQ.

Great. Thanks, Mike. And I'm very excited to provide a commercial update on the UKONIQ launch as we report revenues for the first time. With this launch, we're not only bringing an important new option to patients, but we are setting the foundation for multiple potential future approvals, including the combination of UKONIQ and ublituximab known as U2 in CLL as our next major milestone. While it is still early, we are pleased with our initial launch execution and feel we have made significant progress against our initial launch objectives. These were to build awareness of UKONIQ's differentiated profile, drive adoption with our targeted customers, ensure a positive first experience, and, as I mentioned, set the foundation for TG in lymphoma as we plan for the anticipated launch of U2 in CLL. In our first partial quarter, we achieved $0.8 million of net sales of UKONIQ. UKONIQ is the first and only dual inhibitor of PI3K-delta and CK1-epsilon and is a unique treatment option for patients with relapsed follicular or marginal zone lymphoma. Consistently, we have received specific and positive feedback about its clinical profile from our customers. Through market research, advisory boards and our field team engagements we have confirmed that UKONIQ is seen as a differentiated product. We've consistently heard that the proven efficacy across marginal zone and follicular lymphomas, its unique mechanism of action, tolerable safety profile, low rates of discontinuation, and a lack of a black box warning are important differentiators with healthcare providers and payers. We believe that these factors help establish UKONIQ in a class of its own. We recognize the second-line marginal zone and fourth-line-plus follicular lymphoma labeled indications represent relatively small patient populations. Therefore, our strategy out of the gate has been to target the higher-volume prescribers at academic centers and large community practices. Further reinforcing our strategy, we estimate that there is roughly an 85% overlap in the prescriber base between indolent non-Hodgkin's lymphoma and CLL. We also view the lymphoma approval as a valuable opportunity to introduce ourselves to the treating community and build the credibility and trust that will be critical to the CLL launch. So far, UKONIQ's initial uptake indicates that this strategy was well informed, with the majority of our initial use coming from targeted customers. Uptake has been roughly 50/50 between the academic and community settings, with many of our early adopters having prior clinical trial experience with UKONIQ. While our customer-facing teams have been resourceful and strategic in their approach to engage and educate our customers, COVID restrictions have posed some challenges. Physicians report being Zoom fatigued after over a year of virtual engagement. However, the good news is that we are seeing live engagements continue to increase and believe COVID restrictions will continue to dissipate over the next several quarters, which should accelerate customer engagements going forward. Our latest market research shows that over 80% of our target customers are aware of the UKONIQ approval and approximately 90% of the physicians we surveyed have met with a TG representative either live or virtually. We view the efficacy and safety profile of UKONIQ as favorable versus available options. We believe this to be very positive and demonstrates the effectiveness of our early launch efforts. On the patient access front, we worked hard to provide robust service offerings immediately upon approval through our TG Patient Support Program, which has received very positive feedback from patients and healthcare providers. UKONIQ is now covered for 85% to 90% of Medicare and commercial lives. Additionally, UKONIQ has been added to the U.S. Oncology Clearview pathways for follicular lymphoma consistent with our label. UKONIQ has also been added to the NCCN guidelines as a 2A option for patients with fourth-line follicular, fourth-line-plus follicular and second-line-plus marginal zone lymphoma. Together with payer coverage these inclusions further enable patient access at institutions and practices. Overall, we are pleased with the launch progress to date and we are positioning ourselves for success as we prepare to potentially launch U2 in CLL. We have some of the most talented commercial people in the industry at TG and despite launching during a global pandemic, I believe we have made great progress with the UKONIQ launch today. With that, I'll turn it over to Sean Power.

Thank you, Adam. And thanks again to everyone for joining us. Earlier this morning, we reported our detailed first quarter 2021 financial results, which can be viewed on our website at www.tgtherapeutics.com. For today's call, I'll touch on a few highlights from the quarter. Beginning with our cash position: we ended the first quarter with approximately $525 million in cash, which we believe will be sufficient to take us into 2023. As Adam noted earlier, following the FDA's accelerated approval of UKONIQ on February 5, we were pleased to report $0.8 million of UKONIQ net revenue in the first quarter. Our net loss for the first quarter of 2021, excluding non-cash items, was approximately $74 million, compared to approximately $40 million in the first quarter of 2020. The increase in net loss as compared to the first quarter of 2020 is primarily related to increased selling, general and administrative expenses associated with the preparations for and now execution of the commercialization and launch of UKONIQ, which occurred in the first quarter of 2021. Additionally, during the first quarter of 2021, we saw an increase in R&D expenses over the 2020 period, which was primarily driven by one-time licensing milestone payments of approximately $14 million, consisting in large part of a $12 million milestone due on approval of UKONIQ. Our GAAP net loss for the first quarter of 2021, inclusive of non-cash items, was $90.6 million or $0.69 per share, compared to a net loss of $51.1 million or $0.48 per share during the comparable quarter in 2020. With that, I'll now turn the call back over to the conference operator to begin the Q&A.

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

Hey, guys. Thanks for taking my questions. And congrats on the launch. A couple. One, can you talk maybe a little bit about the breakout roughly between marginal zone lymphoma and follicular lymphoma that you're seeing? I know it's a small number, but I just wanted to get a feel for which way the tide is cutting. And then, I was curious just on early feedback around some of the gastrointestinal toxicity that has been seen in the past, and what physicians have been seeing and patients have been seeing there. And then my third question is just, was there any inventory stocking? Thanks.

Adam, do you want to—if you have any information yet on the breakout between follicular and marginal zone and the stocking question?

Sure. Yes. So from what we've seen so far, and it's early, but we've seen demand for both marginal zone and follicular. It's hard to estimate exactly the breakdown, but we've seen usage in both, so we were very happy to see that. As far as the stocking question, given that many practices only see a few follicular or marginal zone patients per year, we anticipate pharmacy ordering generally to be on an as-needed basis. So we have placed some inventory with distributors to fulfill pharmacy orders consistent with industry norms for a product like UKONIQ. And then, regarding GI toxicity, so far, so good. It's obviously still early, but the reaction to the profile has been very good. We've been educating customers to stay on top of it and be ready and know how to treat it if they see it. But so far, so good.

Great. Thank you.

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

Hi, good morning. Congratulations on all the progress, obviously commercial and R&D. Thanks for taking the questions. I guess first off for the confirmatory trials—what the status was and maybe some information around the designs for the confirmatory studies for follicular and marginal zone, any updates or color on that side of the story? And then, moving towards the end of the year, maybe a level set in terms of what kind of information we can expect from the pipeline. I know you said 1701 at ASCO, but what are the key highlights and data expectations for ASH at the end of this year, if you might? Thanks.

Sure. So on the confirmatory trial, we don't want to say too much yet. We have noted in the past that we had a basic design discussed with the FDA, but we do need to finalize that. I think it's going to be in and around what other companies have announced previously for their confirmatory trials. Our hope is to get it up and running before year-end. We'll give a lot more details in time, but again, there is a relatively standard trial design that's out there that other companies have announced, and I think we'll be more aligned with those kinds of studies. In terms of pipeline updates this year: as I noted, we'll have some more information on TG-1701 at ASCO. I've been pleased with the results that we saw at ASH and I've encouraged folks to take those results and line them up with other BTKs, both covalent and non-covalent, to see for themselves. We'll have more information available at ASCO and I imagine even more available at ASH later this year. For ASH as well, as I noted in my prepared remarks, we do hope to have approximately twice as many patients—so nearly 50-ish patients—available for that 12-month endpoint for the U2 plus venetoclax Phase 1 trial. So that is our goal for the U2 plus venetoclax dataset. The Phase 1 follow-up should have close to all patients to that point. For the Ultra-V Phase 2 portion, as we noted, we finished enrollment earlier this year with 165 patients. We won't have all 165 patients through 12 months by ASCO, so the question is whether any of it gets presented in a partial format or it's held to a full presentation. That will be primarily an investigator-driven decision. We will have plenty of Phase 1 data and then Phase 2 to come. If we can get some Ultra-V data at ASH we'll do it; if not, that will be a fuller dataset available for ASCO in the June timeframe of next year. For TG-1701, we've got our fingers crossed; we'd like to present some early data at ASH this year. TG-1801 is our CD47/CD19 bispecific; we've just opened the trial in the U.S. Having started ex-U.S., we weren't able to move as fast as we'd have liked, but things are starting to accelerate. Our goal is to get some information out on that compound by year-end. Those are probably the major updates for later this year.

Okay. All right. Maybe just to remind us: the Phase 2 portion of the Ultra-V study, does that have the possibility to have a registrational implication?

Yes, it is possible. It's something that's probably going to be somewhat challenging as a single-arm study with multiple drugs, but once we have all the data put together, we'll definitely have a conversation with the FDA and see what their appetite is for accelerated approval. We know accelerated approvals in CLL are challenging these days for them, but we do feel the data will be quite encouraging. We'll take our shot—no guarantees, but we'll take our shot. If not, again, we think it's a very robust dataset that should provide potential updates to the NCCN guidelines. Our Phase 3 is ongoing and will be enrolling. Both drugs are approved and physicians can make their own decisions. Again, best case scenario would be approval; second option would be that it will be useful for compendia listing. That's also valuable. The registration trial is ongoing.

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

Thanks, Chris.

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

Thanks for taking the questions. A few primarily housekeeping questions. For SG&A, the non-cash comp cadence—it looks like it's second-half loaded over the last 18 months. Is that by design or coincidence? And then for the R&D milestones that you booked in the first quarter, are there any additional ones that you would expect to book in 2021? And then last question: can you update us on your plans for ex-U.S. commercialization and territories for which you have the rights? Thanks.

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

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

OK, what's the approximate size of that milestone, Sean?

Low double-digit million.

Okay. And then in terms of ex-U.S., Josh, we are still working out the details there. Adam and his team have been doing an impressive evaluation of what's the best approach. We've given ourselves a little bit of time to make those decisions after approvals for U2 and for ublituximab in MS. We're going to focus here in the U.S. on approvals and then work toward approvals abroad. Right now the team is leaning towards keeping it internal and launching ourselves at least in the major European markets. Opportunistically, we'd look for partnerships in places like Japan or China, but probably the major European markets we are leaning toward doing ourselves.

And what are the timelines for registration in Europe?

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

Thanks very much.

Thanks Josh.

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

Hi, good morning. Thanks for taking the question. A couple. First on UKONIQ commercialization: do you have a sense of repeat prescribing patterns so far? What are you anticipating in terms of growth in new patient adds and duration on therapy over the course of 2021? And then following up on Ultra-V’s registration potential: how should we think about approval timelines relative to the Phase 3 trial if the Phase 2 itself isn't sufficient for approval? And is the Phase 3 trial a headwind to U2 commercial uptake, assuming U2 will be approved earlier? Thanks.

Sure. Adam, you want to tackle the UKONIQ commercial question?

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

Right. Thanks, Adam. And in terms of approval timelines for Ultra-V Phase 3, what should we expect?

We think there's probably going to be a 12- to 18-month accrual period and then a similar 12- to 18-month follow-up. There are two cohorts built into the study: relapsed/refractory and frontline, which could enroll at different paces. The relapsed/refractory cohort could read out earlier, perhaps in a 24- to 36-month timeframe. The frontline will likely take longer. The studies are separately powered so they can be completed independently. In terms of headwinds, I don't see significant ones. Venetoclax is used in the community but is not yet fully adopted broadly; the academic centers have higher uptake. Our focus is to have the data and labeling in place as the market evolves and venetoclax becomes more widely used in the community. We aim to build U2 as U2 first before rolling out the combinations. So timing is working in our favor, and we don't view the Phase 3 as a meaningful headwind to the commercial potential of U2 itself.

Okay, got it. Thanks for taking the question.

Thanks, Eric.

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

Good morning. Thanks for taking my question. Following up on your European strategy: you mentioned doing it alone in Europe and partnering in Japan/China. Does that apply for the MS opportunity as well?

As of the moment, yes. To be clear, we're leaning toward that approach, but we haven't finalized all decisions.

Okay. Thanks again.

You're welcome.

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

Hi, good morning, guys, and thanks for taking the questions. Just wanted to focus a little bit on the initial use you're seeing of UKONIQ in community versus academic settings. You mentioned about 50/50 initially—do you expect that to change over time? And when you add U2 to the commercial profile, how do you think that will roll out in terms of community versus academic?

Yes, we were pleased to see the split between academic and community in the initial uptake, which we think is good. The vast majority of these patients are treated in the community but dispersed among many community physicians, whereas in academic centers it's more concentrated. We have focused on academic centers but are also reaching out into the community. This split seems about right. Over time, as the product becomes more widespread across the community, community uptake could increase. Regarding U2, adoption will similarly involve both academic and community centers. We expect academic centers to continue to be important early adopters, and as familiarity grows, community adoption should pick up.

And has there been any issue in terms of patient access despite the payer coverage you mentioned—any access issues obtaining authorization or reimbursement?

Nothing unusual for a launch product. Everything we've seen is normal as we get on formularies, and we've not seen any unexpected issues.

And then regarding ULTIMATE I and II, how should we think about differentiation in the marketplace for ublituximab?

The easiest differentiator is the one-hour infusion every six months after the initial dosing. We're actively engaging payers to understand what it will take to create the best access possible for patients, and if we can identify a price that enhances access we'll consider that. Clinically, we were very pleased with ULTIMATE I and II: the ARR numbers are very low and among the best seen in Phase 3 MS trials. We believe the efficacy and safety profile looks as good as or better than existing options, and combined with convenience—and potentially pricing—we think ublituximab will have strong differentiation in the marketplace.

Thanks, Mike. Congrats on the progress.

Thanks, Matt.

Our next question comes from Sahil Kazmi on behalf of Mayank Mamtani with B. Riley. Please proceed.

Hi. Good morning. This is Sahil on for Mayank. Thanks for taking our questions. Regarding the Ultra-V Phase 3 study, could you discuss the thought process and rationale about having U2 as the active comparator arm? Any underlying assumptions on surrogates like ORR or PFS, and any key learnings from the CLL14 program with venetoclax and GAZYVA that informed your design?

I think U2 was a natural choice for the control arm because it's a very active regimen based on our prior studies and we understand its profile well. We have run clinical trials with U2 extensively. By the time the study would read out, we expect U2 to be an approved regimen in CLL, so it makes sense to compare U2 plus venetoclax versus U2 alone. This gives a clear comparison. We also expect that as GC (obinutuzumab plus chlorambucil) becomes less usable, U2 is likely to be used as a control arm more broadly. The study design draws on learnings from prior venetoclax combination trials but uses U2 as an active control to directly measure the added benefit of venetoclax.

Makes sense. Thanks very much and congrats on the quarter.

Our next question comes from an analyst with Goldman Sachs. Please proceed.

Thank you very much. Good morning, everyone. Thanks for taking my questions. Two quick ones: first, as you think about current uptake and the progression of uptake through the balance of the year, any thoughts on the impact of post-COVID vaccination and when you might see an inflection in live interactions? And second, you have products in both oncology and MS—could you provide your perspective on where you see the most tangible synergies between those two areas, whether in R&D, commercial operations, or elsewhere?

It's still early, and we're enthused by the positive reactions to UKONIQ's profile. These are small patient populations and we've had a limited time so far to see trends. With increased live engagements as COVID restrictions ease, we expect more meaningful discussions and adoption. Live engagements are increasing and we believe that will accelerate over the next few quarters.

On the portfolio and synergies: it starts with the science—these are diseases characterized by aberrant B cells. In oncology you have malignant B cells; in MS and autoimmune indications you have aberrant B cells involved in the autoimmune cascade. Scientifically, there's a big overlap which allows us to consider maneuvering our compounds across both therapeutic areas. Commercially, we'll need sales and medical teams focused on MS, but many of the underlying commercial operations and organizational infrastructure we've built will support both areas. There's synergy in clinical development, translational science, and back-end commercial operations.

Okay, thanks so much.

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

Great. So, just want to again thank everyone for joining us. We had a nice start to the year and we're looking forward to some exciting additional items for the remainder of the year. To summarize: first, we'll continue to execute on the commercialization of UKONIQ in both relapsed and refractory marginal zone and follicular lymphoma. We are waiting to hear from the FDA regarding whether they've accepted our BLA for filing for U2 in both previously untreated and relapsed/refractory CLL. Assuming positive news and they accept that filing, we'll work closely with the agency to advance the application as quickly as possible. We're going to complete the BLA submission for ublituximab in RMS, targeted for the third quarter of this year. As part of that, we'll be preparing our commercial organization for a potential CLL launch and building out for ublituximab in RMS. If we file in the third quarter, a typical target for approval would be about 12 months after that, so roughly late 2022 as a target. Beyond that, we continue to advance our pipeline: the Ultra-V Phase 2/3 trial is ongoing, we're looking to potentially move TG-1701 into Phase 3 this year, and our earlier pipeline assets, TG-1801 and TG-1501, continue to progress. Later this year we look forward to presenting more data on the U2 plus venetoclax combination and additional data from TG-1701 at ASCO and potentially ASH. We may also have Phase 1 data from TG-1801. So it will be a very busy remainder of the year. We have a lot to execute on and a great team to do it. On behalf of everyone at TG, thank you for your support and for joining us today. Have a great day.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a great day.