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spk10: Greetings and welcome to the TG Therapeutics third quarter 2021 earnings 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Senior Vice President, Corporate Communications. Thank you, Jenna. You may begin.
spk03: Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third quarter 2021 financial results and provide a business update are Michael Weiss, our 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 developments as well as provide an update on the current pivotal programs and key remaining goals for 2021. Adam will then 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 we'll be making some forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about our anticipated future operations and financial performance, including sales performance, projected regulatory milestones, clinical development plans, and expectations for our marketed and pipeline products. 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 SEC filings, including our most recent reports on Forms 10-K and 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 at 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 would like to turn the call over to Mike Weiss, our CEO.
spk12: Thank you, Jenna, and good morning, everybody, and thanks for joining us. 2021 has been a pivotal year for TG as we transition from a purely development stage company into a fully integrated commercial organization. With the launch of Uconic and the continued build of our commercial platform, TG has grown tremendously this year. I'm incredibly impressed with the team we've built and excited to see everyone working so closely together toward our common goal of developing and commercializing novel treatments for patients with B-cell diseases. The team's hard work and effort this year have established our commercial footprint that I believe will pay dividends in the coming years as we intend to leverage our commercial platform for multiple potential future launches, including, of course, U2 and CLL and Ubotuximab and RMS, both of which we are targeting for 2022. And beyond that, from our robust B-cell pipeline that we will touch briefly on later. Since this call is occurring hot off the heels of our live participation in the Consortium of Multiple Sclerosis Clinics annual meeting, referred to as CMSC, and ASH abstracts won't be available for another 20 minutes or so, I thought I'd kick off the call by discussing our multiple sclerosis program. Perhaps the most exciting news from this past quarter was that we completed our biologic license application, or BLA, submission to the U.S. FDA for rublotuximab, a glycoengineered anti-CD20 monoclonal antibody to treat patients with relapsing forms of MS. We submitted this application in late September, and we look forward to hearing back from the FDA in late November on whether they have accepted this application for filing. Assuming all goes well, we would anticipate a target PDUFA date in late September of 2022. This past quarter, we also presented at the ECTRIMS conference and shared additional data from the ultimate one and two phase three trials, which supported our BLA submission to the FDA. As a reminder, these trials were conducted under special protocol assessment with the FDA, and importantly, as noted in the past, both studies met their primary endpoint with ubutuximab treatment demonstrating a statistically significant reduction in annualized relapse rate, sometimes referred to as ARR, with ubutuximab treatment resulting in historically low levels of annualized relapse rate. At the EFTRIMS meeting, we also shared data on additional secondary, tertiary, and even some post hoc endpoints to offer the MS community additional color around the highly successful primary endpoint. We believe the additional data presented further demonstrates the potential benefit of Upatuximab to treat patients with RMS with a one-hour infusion every six months following the initial starting dose. As a reminder, we also hosted a virtual event during the ECTRIMS conference And I encourage anyone who is interested in TG to go to our website to listen to a recording of this event and listen to the KOLs provide their thoughts on Ubituximab and the data presented thus far. Furthermore, at the recent CMSC annual meeting, I personally had the opportunity to meet with a number of key opinion leaders, and I have to say the feedback was overwhelmingly positive and provided tremendous insights to help us best position Ubituximab for success in MS. Next, let's review the UnityCLL Phase 3 program. As you may recall, we submitted and received a PDUFA goal date of March 25, 2022, for a BLA and an SNDA, requesting approval of the combination of Uconic plus Ublatuximab, for those of you who knew, referred to as the U2 combination, for treatment of patients with CLL. These applications were supported by the the data from the Unity CLL Phase 3 program, which achieved its primary endpoint and showed patients treated with U2 achieved a statistically significant improvement in progression-free survival as compared to patients who received chemoimmunotherapy. This trial was conducted under a special protocol assessment with the FDA. With many CLL patients seeking a new treatment each year, we are excited about the potential to leverage the commercial platform we built this year around Uconnick to commercialize U2 for patients with CLL, if approved. In particular, for those patients who may not be good candidates for current standards of care, as well as those who have failed currently available options and are in need of an alternative treatment. Now, let me turn to Uconnick. As a reminder, in February of this year, the FDA granted accelerated approval of Uconnick as a single agent for the treatment of adult patients with a relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen, and for adult patients with a relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy. This approval was based primarily on the results from the UNITY NHL trial, which were subsequently published in the Journal of Clinical Oncology. As for the launch, I'll keep my comments brief and let our Chief Commercialization Officer, Adam Waldman, provide the details. Despite the challenges posed by COVID, I've been very pleased with the performance of our team. I got a chance to meet most of our sales team in person recently, and I have to say, what an impressive group. True professionals with vast experience, working hard to establish our commercial footprint by introducing Uconic and TG to the broader community of oncologists. One of the team's key goals has been to educate and build awareness with as many healthcare professionals who treat MZL and follicular as possible, keeping in mind that most of our current target prescribers are also the clinicians who treat patients with CLL. So, all the hard work building prescriber base with experience with single-agent Uconic and MZL and follicular should bolster our launch efforts for U2 and CLL, if approved. Through their efforts, our teams have engaged live and virtually thousands of healthcare providers, and the Econic prescriber base continues to grow, and importantly, we are seeing increasing uptake in community practices, which we believe will be integral for the potential success of U2. Lastly, I wanted to spend a few minutes discussing a couple of additional pipeline programs, which we hope will drive better outcomes for patients and become future drivers of growth and expansion of our hematology oncology commercial platform. Starting with U2 plus venetoclasts. As a reminder, the Ultra V phase three trial evaluating this triple combination is now enrolling patients with treatment naive and relapsed or refractory CLL. The phase two portion of this study completed enrollment with approximately 165 patients earlier this year. Most recently, at the IWCLL conference, Dr. Paul Barr of the Wilmot Cancer Center in Rochester, New York, presented updated results from his phase one U2 plus ven combination, which now includes approximately 47 patients treated with the triplet regimen. Best overall response was 100% among the valuable patients, including a 37% complete response rate. Importantly, at cycle 12, 91% of the 34 patients achieved undetectable minimal residual disease in the peripheral blood and 72% of 32 patients achieved undetectable minimal residual disease in the bone marrow. We see these data as highly encouraging, and we look forward to providing updates from the Phase I and Phase II studies next year. Also, at IWCLL, we presented data on TG1701, our investigational BTK inhibitor, as a monotherapy and in a triple combination with Mu2. We were pleased to see that with additional patients TG1701 continued to show encouraging clinical activity paired with what appears to be a tolerable safety profile. Also, important to note, we hosted a virtual event during the IWCLL conference, and again, I encourage those of you who are interested in TG to go to our website and listen to the feedback directly given by the KOLs about this novel regimen. These are exciting combinations, and I believe not only speak to the utility of U2 as a backbone in triple combinations, but also highlight the potential benefits of our combination approach and our B-cell platform that should provide us with a steady stream of commercial opportunities. To wrap up, I wanted to quickly review some upcoming goals and objectives for the remainder of 2021 and into 2022. First, we look forward to hearing from the FDA regarding our BLA submission to treat patients with relapsing forms of MS. We also will continue to work with the FDA on the YouTube BLA slash SNDA for patients with chronic lymphocytic leukemia, which has a BDUFA target goal date of March 25th, 2022. We plan to have an exciting ASH conference in December, so next month, and we're looking forward to having a live presence there. So that's going to be very exciting. As mentioned, in just a few minutes at 9 a.m., so about 12 minutes from now, the abstracts will go live. We think this will be a great conference for us as we're presenting data showcasing the potential value and utility of U2 as a doublet combination therapy and also as a backbone of triple combinations. Of course, we will continue to focus on the commercialization of Uconic and relapsing refractory marginal zone and follicular lymphoma and expand our commercial footprint in preparation for potential future launches, including U2 in CLL and uvlutuximab in relapsing forms of MS. We are continuing to drive enrollment into our Ultra V Phase III trial, evaluating the triple combination of U2 plus venetoclasts in both treatment-naive and relapsed refractory CLL, and we plan to continue to advance our early pipeline candidates including TG71, our BTK inhibitor that we've been talking quite a bit about, but some earlier stage compounds as well, including TG1801, our anti-CD47, CD19 bispecific, and TG151, our anti-PD01 antibody. With that, I'm excited to turn the call over to our Chief Commercialization Officer, Adam Wallman, to share some highlights from our early commercialization efforts. Adam?
spk11: Yep. Thank you, Mike. Good morning, everyone. I am pleased to provide an update on our core commercial activities for the third quarter as we continue to build on the iconic launch and create a strong commercial platform capable of supporting multiple future launches. I'll start with what we are seeing in the overall market, present sales numbers, and then provide some qualitative detail on the launch. Finally, I'll cover our priorities and activities to set the stage for upcoming potential launches in CLL and MS. Our commercialization teams continue to perform well in the third quarter. However, COVID continues to create challenges for patients and healthcare providers. As we continue to understand the impact, we have looked at claims data, syndicated reports, and spoken with providers directly. And they all confirm that patient visits and treatment initiations for patients with endometrial lymphoma remain below pre-pandemic levels. As you're aware, indolent lymphoma patients tend to be elderly and at risk, causing providers to exercise greater caution in balancing potential patient exposure to COVID with the need for changes in treatment. While we are confident in our strategy and execution, we continue to face challenging market conditions with the ongoing pandemic. Despite these challenges, we've seen some nice bright spots. The overall demand for Ucona continued to grow. with $2 million in net sales for the quarter, representing an increase of 32% from the last quarter. We are seeing growth in our base of prescribers, as well as number of repeat prescribers and accounts. Further, we are seeing growing use in the community, with approximately 65% of our Q3 new patient starts in the community versus 35% in the academic centers. We think that this is an encouraging trend, as most of the community physicians that are prescribing Uconic for follicular and marginal zone are the same physicians that treat CLL and could prescribe U2 for CLL if approved. Our share of voice was robust during the quarter, and based on third-party research, we have achieved a leading share of voice across follicular and marginal zone markets in both the community and academic centers. Uconic awareness and familiarity among targeted treaters remain high, and prescribers continue to cite strong uconic performance across all key attributes. Again, we believe high Uconic awareness and foundational understanding of Uconic's profile in our currently approved indication amongst our target prescribers will set a strong foundation for a potentially successful U2 launch in CLL. Moreover, we continue to hear positive feedback from customers about their experience with Uconic, the TG team, and our patient support services, and impressively in third-party syndicated research our field teams are right at the top of the NHL category for quality of engagements and overall value. As we have previously shared, ensuring a positive first experience with Econic is a launch strategic imperative, so hearing these positive feedback is particularly gratifying. Finally, based on market research, when prescribers understand the unique MOA, the differentiation on safety and tolerability, as well as the compelling efficacy, this does translate into a strong intent to prescribe. We believe these are positive indicators and give us confidence in our overall strategy and approach to the Uconic launch. As mentioned during our last call, we are seeing Uconic demand from patients who are facing drug affordability issues. As a result, through our TD patient support program, we have provided Uconic free to about 35% of patients. We are proud to be able to support these patients in need by providing assistance when there are barriers to access. To summarize, we're very pleased with the Uconic launch. Our goal since day one of this launch was to start laying the foundation and building our commercial capabilities for future launches. This initial launch of Uconic is allowing our teams to establish strong relationships with cancer centers and healthcare providers while ensuring initial positive experience with Uconic and TGs. We estimate there is roughly an 80 to 85% overlap of our target prescriber base between non-Hodgkin's lymphoma and CLL, reinforcing the importance of establishing our footprint with this launch. We are excited to expand our commercial platform with the potential launch of our second drug, Ubicuximab, as part of the U2 double combination with Uconic and CLL early next year in the U.S. market, and believe our preparedness and our experience with the Uconic launch will be invaluable to our success. Now, turning to the MS launch readiness, as Mike mentioned, now that we have submitted the BLA for Ubletuximab in RMS, our team has also accelerated our launch preparations. We significantly strengthened our core capabilities in Q3, making critical hires in key home office and field-based roles. The team has deep and longstanding ties to the MS community. Our team significantly ramped up their activities in Q3, actively engaging KOLs, community neurologists, payers, and advocacy groups at conferences, ad boards, and one-on-one engagements. Our confidence continues to grow as the feedback in the Ubutuximab profile has been very positive across the board, and our belief is there is a very compelling commercial opportunity here. In particular, neurologists view Ubutuximab's efficacy and tolerability profile as impressive and highly competitive with existing CD20s. Ubutaximab shorter infusion and flexible pre-medication and post-monitoring requirements demonstrated in the ultimate one and two trials are also seen as significant advantages. In summary, we continue to build and strengthen our core commercial capabilities and footprint as we ready the organization for multiple upcoming launches. We continue to make nice progress with our iconic launch as utilization and experience at community and major cancer centers continues to grow and and awareness of Econic's profile continues to expand. We have also made significant progress preparing the organization to optimize the potential launch of U2 and CLL early next year, and the potential launch of buproximab and MS late next year. With that, I'll turn the call over to Sean.
spk06: Thank you, Adam, and thanks again to everyone for joining us this morning. Earlier this morning, we reported our detailed third quarter 2021 financial results, which can be viewed on the investors and media section of our corporate website. For today's call, I'll touch on a few highlights from the quarter, beginning with our cash position. We ended the third quarter with approximately $381 million in cash, cash equivalents, and investment securities, which we believe will be sufficient to take us into 2023. As Adam just noted, we reported $2 million of UConn net product revenue in the third quarter, representing a 32% increase over the second quarter of 2021. Cumulatively, in the first seven months of launch, we have recognized approximately $4.3 million in net product revenue. Our net loss for the third quarter of 2021, excluding non-cash items, was approximately $72 million. in line with our expectations, which was an increase of $10 million quarter-over-quarter from Q2 of 21, where we saw a net loss excluding non-cash items of approximately $62 million. As compared to the second quarter of 2021, the increase was primarily driven by an uptick in research and development costs pertaining to our BLA filing for ublituximab in MS and an increase in CMC expenses incurred in Q3 of 21. Comparing this quarter to Q3 of 2020, where we saw a net loss excluding non-cash items of approximately $59 million, the increase is primarily related to SG&A expenses associated with the launch of Econic and planning for the potential future launches of U2 in CLL and Ublituximab in RMS. Our gap net loss for the third quarter of 2021, inclusive of non-cash items, with $85.6 million, or $0.65 per share, compared to a net loss of $87.2 million, or $0.73 per share, during the comparable quarter in 2020. With that, I will now turn the call back over to the conference operator to begin the Q&A.
spk10: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment please while we poll for questions. Thank you. Our first question comes from Alethea Young with Cantor Fitzgerald. Please proceed with your question.
spk02: Hi. Good morning, and thanks for taking our questions. This is Nina on for Alethea. We are wondering if we can expect Ultra-V data by year end, or should we expect that in 2022? And if I can have another one. We are also wondering what are the challenges for Medicare funding for patients with marginal zone lymphoma? and follicular lymphoma, and how are you seeing that dynamic play out, and what can you do to minimize that impact? Thanks.
spk12: Sure. Thanks for the question. So in terms of Ultra-V, the expectation is that we will have data probably middle of the next year conferences, so the ASCO, EHA, maybe I think Blugano, that kind of focus, end of this year, or ASH, which Now the abstracts are live as of 9 a.m. You'll see that no Ultra-V, but we've been talking about that for a while, that Ultra-V wouldn't be until next year. In terms of the Medicare funding for patients with marginal zone and follicular, I'll take a crack at it, and if I miss anything, Adam can chime in. For the most part, these patients are on Medicare. They're I hate to use the word elderly since I think I'm approaching the average age of folks with marginal follicular, but it's an older patient population. Many of them are on Medicare. Most of them do have coverage. The problem is the co-pays associated with Medicare. So the only way for companies to really help patients with co-pays that are on Medicare is to either provide support to charitable foundations that then in turn can help provide some of that support or provide the drug for free. So most of the patients have good coverage except they are responsible for a portion of their drug cost and even those small portion they cannot afford. So that's why we see the free goods that we're giving away are for those patients who essentially can't afford their co-pays. They all have, I won't say all, but The vast majority of them have insurance. It's just they still can't afford the co-pays. Adam, did I miss anything there? Yeah, sure.
spk11: Yeah, the only thing I would add is that the reason we're experiencing issues in this particular lymphoma is that there just is not availability of co-pay foundation support. we don't expect that we'll have the same issues in CLL where there is more access to funding. The funding is done by indication, so we're not seeing it. There's not a lot of it in lymphoma, but we do think the issue will have a less impact on CLL because there is funding available there.
spk06: Thanks. That's helpful.
spk10: Thank you. Thank you. Our next question comes from Eric Joseph with JP Morgan. Please proceed with your question.
spk00: Good morning. Thanks for taking the questions. A couple from us. The first on Uconic, which is whether you saw any sequential shifts in gross to net versus second quarter and perhaps how we should be thinking about that into year end. And whether at this stage, as we look to, you know, expansion with YouTube for CLL, is there anything you might guide at this point in terms of how to think about gross net in the CLL setting? And then perhaps as it relates to Uglutuximab for RMS, can, with sort of your, you know, your launch pre-commercial preparations underway, can you just talk a little bit about sort of the concentration of, the prescriber account base there, and I guess coming away from that in terms of what messages are resonating strongly, I think, with the treatment community and what impact is relative price playing in your discussions with providers right now?
spk12: Sure. So, Adam, why don't you, if you could, help me out on the... on the gross to net questions for Uconic and for what we anticipate in CLL, and then we'll tag team on the RMS stuff.
spk11: Yeah, Eric, thanks for the question. The gross to net is, as you know, variable based on the type of patients that come into us and the site of care. So there will be a little variability, and given the low patient volume, there can be swings from quarter to quarter. but it's largely in line with where we thought it was going to be, and there's not major, at this point, there haven't been major shifts in gross to net. That was the first question. What was the second question? Was around, did you want to take the second question?
spk12: Yeah, we'll just finish off.
spk11: Yeah, oh, too early. CLL, right. So CLL, too early to give any insight on gross to net and CLL.
spk12: Got it. Okay. And then in terms of OOBLI and RMS, it's a short question. Concentration of prescriber base, I'll give an answer. Adam, correct me if I'm wrong. My understanding is that there's about 500 centers, Eric, that represent about 80% of the total population. cover 80% of the patients. So it's really highly concentrated in major centers here in the U.S. And in terms of things we heard coming out of ectroms, I think you particularly wanted to understand how price may impact. The things that, so both from ectroms, but as I mentioned in the preparatory remarks, I really had a great opportunity to meet directly with KOLs when I went to the live CMSC conference, I'd say, again, overall, very, very positive feedback. People are very excited about the one-hour infusion. I think that's something that, you know, is definitely attractive, particularly for all the patients and for any of the physicians that have, you know, infusion centers or associated with infusion centers, the one-hour infusion is really something that's quite attractive. They really like the mechanism. You know, a lot of people were digging in on the glycoengineering aspect of ovipletuximab, the different, you know, epitope binding sites. Definitely, you know, people were understanding that this is a differentiated CD20, and that was generating a bit of excitement. And then circling back to price, you know, what we hear now consistently is that access is important. is probably more important than price. Assuming we can use price to buy access, price matters. But really it's a function of, you know, when they have an option for patients, they want to know that they can get the patient on the drug that they choose and they want to know to get them on the drug quickly. They do say that, you know, they do sometimes have challenges with Okravis and getting patients on in a timely fashion. So there's definitely room for improvement there. And, you know, our payer team is out there hustling every day to try to identify ways in which we can cut through as much of the red tape as possible. And we've said this multiple times. If price gets us there, we'll use price to do what we can to create the best access for Obituximab and RMS. Adam, any additional thoughts?
spk11: No, Mike, I think you got it. Thank you.
spk00: Great. Thanks for taking the questions.
spk11: Yep.
spk10: Okay. Thank you. Our next question is from Ed White with HC Wainwright. Please proceed with your question.
spk09: Good morning. The question will start off for Adam. Can you comment on the, you know, percentage of live engagements with the prescribers right now and Are you seeing any changes as we work our way through the pandemic? And how is it going with the education of the providers for Euconics? Do they understand the differentiation? And maybe if you can tell us some of the challenges that you might be seeing.
spk11: Sure, Ed. Great question. We were certainly seeing some increases in live engagements towards the early summer months. As Delta picked up, that definitely declined as cancer centers went back to COVID restriction policies that made it more difficult to get to live engagements. We're hopeful now that the The Delta variant has gone down. We're starting to see pickup now back into the fourth quarter, which is great. We do believe live engagements are a much more effective way of communicating. We've said before that there is a bit of fatigue with the HEMOC community with the Zoom calls that have been going on. Although we still do it, we think live engagement is just a more effective way of educating people. You know, what we've done, I mean, the challenges that you asked about, yeah, this is a challenging environment, no question. What we've done in response is we've increased our digital and non-personal efforts. We've had to be innovative in the way that we've done our educational programs. And it is very clear to us that when we do put the profile and we do have the opportunity to get the profile in front of physicians, that the feedback is largely very, very positive. It's just a matter of being able to do it and do it on a frequent basis, right? Sometimes it takes, especially with a new product, it does take multiple visits sometimes, multiple interactions for people to appreciate the full profile and to identify patients. So that is a continuing challenge is we can get in, but then the frequency of which we get repeat visits has been difficult. Like I said, we've developed innovative educational programs and speaker programs, different types of modalities to do that. And we're continuing to adjust as the COVID environment is continuing. The dynamics from that are continuing to change really from month to month. We've also increased our investments in data to try to identify patients. So that is another area that You know, we feel like if we can identify patients and know where to go, we can do some interesting things around, you know, better targeting and, you know, we can use that as an access tool to get into prescribers that have patients and the information is very relevant to them.
spk10: Great. Thanks, Adam.
spk09: Now a question on the European strategy. You had mentioned last quarter that that you might target MS before the hematology. Can you just give us an update maybe on your European strategy and also, you know, your thoughts on perhaps partnering?
spk12: Yes, I'll jump in there, Ed. So we haven't made any final decisions, but we are definitely leaning significantly toward bringing MS forward first in Europe. And in terms of partnering, again, I think we haven't made any final decisions. We're certainly leaning toward a go-it-alone strategy, but we're certainly keeping our options open.
spk09: Thanks, Mike. And a last question, maybe for Sean. Just on R&D, you had mentioned the increase was due to the BLA submission and increased manufacturing costs. Should we be thinking of these? Obviously the BLA submission is one time in nature, but perhaps you can give us your thoughts on what's the underlying run rate for R&D and how we should be thinking of it, you know, directionally for the fourth quarter and perhaps if you're willing for 2022. Thanks. Sure, Ed.
spk06: Thanks for the question. I think ahead of potential approval for We may see some lumpiness or some bumpiness in R&D as those CNC costs will run through the P&L ahead of being able to go on balance sheet as inventory. Directionally for 22, I would say if you average the R&D for over the course of 21, it's probably going to be pre-collap with maybe a little bit of an uptick towards the latter half of 22.
spk09: Okay, great. Thanks for taking my questions.
spk10: Thanks, Ed. Thank you. Our next question is from Chris Howerton with Jeffrey. Please proceed with your questions.
spk08: Great. Thank you so much for taking the questions. I guess the two from me first would be just, I guess, related to the CM&C. You know, with respect to kind of heading into the PDUFA dates, what is the preparedness of CM&C and supply, particularly for ublituximab as it relates to both the CLL and MS applications? As a follow-on to that, is there additional supply that will be required to serve the MS market when and if both indications are approved? And then the third question, if I may, for Adam would be, you know, as you're kind of looking at the new patient ads from the community setting, what would you say is the impact of the site experience during the clinical trials that you ran? Thanks.
spk12: Chris, I'll jump in on the CMC stuff. We're feeling very good about our CMC readiness and supply. We've got a long-term supply agreement with the number one antibody manufacturer in the world. We're feeling quite good about where we are with that. In terms of additional supply for MS, on a volume basis, MS is We don't use a lot of material for MS, so it's all subsumed in the overall CMC agreement we have with our supplier. And, yeah, we feel very comfortable, again, that we have plenty of supply through that relationship for both the oncology and CLL and MS launches. Okay. Adam, did you follow the second question completely? Because I personally did not.
spk11: Yep, I did. Yep, I got it. So Chris, in the community and the new patient ads, yeah, we're seeing, yeah, the majority is with sites that have had experience in our clinical trials so that they were part of the trial, the development of the drug in the U.S., so I do think it is, you know, we've said it before, I think that helped, and we are seeing that the use in the community is not exclusively in those sites, but we do see a large percentage of the use coming from sites that were involved in the clinical trials previously.
spk08: Okay. Well, thanks a lot for taking the questions, and I appreciate it.
spk07: Thanks, Chris.
spk10: Thank you. Our next question comes from Mayank Mentani with B. Riley. Please proceed with your question.
spk01: Good morning, team. Thanks for taking our question. So two quick ones for Adam on commercial, and then I have a Ash abstract. Since the abstracts are out now, I guess you can talk about it. So before that, so Adam... Adam, on where we are with the pandemic, sort of going forward question, obviously there are bright spots, people getting vaccinated, especially the high-risk elderly getting the booster. Is there like a pent-up demand dynamic that we should be aware of for any of the upcoming quarters from RELICIP? And then on MS readiness, I was just curious, this Alzheimer's drug dynamic in neurology clinics and even You know, as you prepare, I know it's early, but you are preparing to engage with CMS in some way. How much is that playing a role in your, you know, payer and access conversation within the team?
spk11: Yeah, sure. Yeah, no, I wouldn't, you know, on a pandemic, you know, this stuff is just so difficult to predict. um you know how this is going to go i wouldn't expect there be a pent-up demand i think that uh hopefully as as covid um starts to go go down we will see you know increased um you know patient uh flow um and you know but i don't think there's going to be a big patient you know pent-up demand um So, you know, I think it'll slowly trickle in, and I think that'll be generally a positive. I think as the COVID situation increases, that's generally a positive, and, you know, we're optimistic for the future. As far as the second question goes, Mayak, on the Alzheimer's drug and those dynamics on infusions and MS, you know, the use of the drug has been light as far as I can tell. I don't think at this point we think the Alzheimer launch will affect the access of lubotuximab and MS. You know, it's something that we'll obviously watch and we understand infusion dynamics to be important. Just as a reminder, the majority of MS patients, you know, have commercial insurance, the younger patient population. So maybe slightly different from a reimbursement dynamics than the Alzheimer's situation, although I'm not as familiar with Alzheimer's. I just feel like it's a more older population and potentially a more Medicare population. So I think there'll be a bit different dynamics there from just an insurance mix perspective. Hopefully that answers your question.
spk01: Yeah, and the capacity of neurology clinics may be helpful there too. So on the ASH abstract question, lots out there, Mike, you know, if you can just maybe distill down on where we should focus on and maybe the specific question I had was around your U2 ibuprofen abstract Can you just remind me with your BTK, what do we know about the median treatment duration and where do we stand with the current discontinuation rate there with the ongoing study?
spk12: Yeah. So just starting from there, I'd have to double check, but the discontinuation rate due to AIDS is very, very low with TG1701. Very, very low. So I... I don't have the percentage in front of me, but I know that discontinuation rate is very low. In terms of overall ASH abstracts and things to focus on and the U2 plus BTK abstract that you specifically highlighted. So, you know, it's an interesting ASH for us. We've got two presentations that come out of our Unity NHL trial. We have some data from U2 in marginal zone lymphoma, which I think is looking quite good. And we had some additional data that we haven't looked at in a while. We'll be presenting on U2 in diffuse large B cell, which is kind of intriguing. There's some interesting information there. I think the presentation is coming together nicely. So that's the UNHL. Some interesting data coming in there. We have some nice CLL cuts of the data. Again, these are more tertiary and post hoc analysis. One that I'm obviously quite keen on is we've always said that there's this population of patients who may be poor candidates for BTK inhibitors based on comorbidities or on conmeds, concomitant medications that they need to be on. So we went back through our phase three database to look at what percentage of the patients have comorbidities that could make them poor candidates for BTK and others that are on medications that are contraindicated with BTKs. It's a much larger portion than we had anticipated when we started the effort. So I think that data is going to be quite interesting for folks and really just highlights that there is a need for novel therapies, and U2 can really fit nicely into certain practice settings that we've been discussing for a while now. In terms of BTK, obviously we are quite enamored with our own 1701. We think it's a very, very good BTK inhibitor. We like it alone, and we like it in combination with U2. But in addition, I would say, One of the cooler, to me, cooler trial designs that we have going and plan to expand is the U2 plus ibrutinib, one that will be presented. I think that was the brainchild of Dr. Anthony Nadeau. I just think it's one of the smarter thoughts on how to potentially change the game and how patients are managed even on BTK inhibitors by using U2 to try to essentially create prolonged drug holidays off of BTK therapies. Again, we're dealing with better tolerated BTKs like 1701 and others that are now approved or hopefully will be approved soon. But regardless, anytime you're on a drug, you run the risk of a side effect. This is a study in which we see if we can take patients who are on BTK inhibitors They may be having a good outcome, but they're certainly not able to get off that treatment, so they're on it. Some of them may be experiencing some side effects and using U2 to get to a deeper response, looking at undetectable minimal residual disease, and then getting patients off all therapy and then following them to see how long they could stay off therapy without having to get back on some treatments. So, again, like I said, I think it's one of the cooler designs. I think it's a really neat application of using U2 to help patients get to a better outcome. And, you know, we'll see what the data as it's presented looks like, but I'm quite encouraged by that one as well.
spk07: Thank you, Mike. Look forward to additional details as you guys think about the design. Appreciate you taking that question. Thank you.
spk10: Thank you. Our next question is for Matt Kaplan with Leidenberg Thalmann. Please proceed with your question.
spk05: Thank you. Good morning, Mike and team. I wanted to, I guess, first maybe a question for Adam. Can you talk a little bit about the current status and size of the commercial organization and how you expect it, I guess, to evolve over the next 12 months as you, you know, head into the launch of NCLL for U2? in March, April, and then into, I guess, the MS markets in, you know, the second half, third, fourth quarter of next year.
spk11: Sure, Matt, thanks. So we have about a 70-person, you know, field footprint right now on the oncology side. and I think we've made some opportunistic expansions here for CLL in small numbers that help reinforce the team in areas that we thought we needed some reinforcements, and we're looking for ways to increase our ability to access certain accounts. But largely the oncology footprint is in place for what we need for CLL. We feel pretty good about it. And as we said in the prepared remarks, the experience that we're getting from Uconic launch is going to help us as we go into CLL. On the MS front, as Mike had answered earlier, this is a more concentrated market than perhaps people think. 550 centers of excellence that are seeing 80% of the patients. It sets up for a you know, a field footprint that is a reasonable size. I think most other, you know, competitors are in the 80 range on reps, 80 or so, 80 to 100 on the rep size. And, you know, we're evaluating right now what that will look like for us. But, you know, I think you can use that as a reference for how you might think about the size of our team going forward.
spk05: Okay, that's very helpful. Thank you. And then, I guess, secondly, in terms of maybe more for Adam, too, in your research and, I guess, your outreach pre-approval, how is Obutaximab's differentiated profile with respect to efficacy and potentially with respect to infusion-related reactions and infusion times, how has that been resonating with potential prescribers and what are their They're hot buttons, I guess, that you're hearing back.
spk12: You want to go ahead, Adam? I think Matt wanted you to answer that one, although I could answer it, Matt. Why don't you start, Mike, because you were down there. You were at the ad board last week. Why don't you start and I'll fill in. You're being super polite. You were there as well. But, yeah, look, Matt, for me personally, it was great. I mean, I've been... in and out of the direct interactions with the MS folks, and it was really nice for me to get back in it live about two weeks ago in Orlando. Yeah, I think, you know, people are very impressed with the activity level, the compound. Again, you know, what I've been saying for a long time, some folks are completely convinced it's a better activity profile, and others are, you know, are bucketing it, you know, CD20s all work really well. So I think You'll get a mixed reaction. No one thinks it's inferior, so that's good. So it's everything most people would say on par or better from an efficacy standpoint. I think overall people were excited about the infusion times and the associated infusion-related reactions. I think When you talk to folks, okra definitely has its issues on the infusion side that people are pretty aware of and somewhat vocal about. So I think they looked at the IRR data and were actually quite comforted by it. So I think all systems are go from what I could tell. Again, I think key attributes, you know, the activity profile, safety, everything's got to be in line and to the better, and I think that's where people perceive it. And then, you know, the hour fusion is extremely attractive. But the big one, as I mentioned earlier, is all about access. So to the extent we can drive great access, you know, ideally through price, then we'll be in a great position. We'll be in a great position regardless, but it is an access game. People want to just make sure they can pick the drug that they want at the time they want to give it, and they don't want to have too many hassles, which is understandable when you think about 500 centers treating 80% of the patients. The throughput volume is really tremendous.
spk05: Great. Thanks, Mike. And I guess one last question, Mike, you mentioned in your kind of walkthrough of ASH abstract highlights. U2 and DLBCL, some new data there being intriguing. Any thoughts on potential next steps with development for DLBCL?
spk12: You know, we're still just putting it all together in terms of the data. But, yeah, I think it's something we're going to look into. And step one is let's get U2 approved for CLL. And then step two is we can look to a supplemental filing and seeing, you know, fully evaluating which data sets could be part of that supplemental filing. We think U2 and marginal zone is certainly a potential candidate for inclusion in that kind of a filing as well. And, yeah, we'll take a hard look at the diffuse RGB cell and see if we can include that in a filing too.
spk05: Great. Well, thanks for taking the questions and congrats on all the progress.
spk07: Thanks, Matt.
spk10: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mike Weiss for any closing comments.
spk12: Well, since the hour is late, the market's already open, I'll keep this quite brief and just thank everyone for joining us this morning and continuing to support us. Have a great day. Thank you.
spk10: This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.
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