Tg Therapeutics, Inc. Q3 FY2021 Earnings Call

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. 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.

Thank you. Welcome, everyone, and thanks for joining us this morning. I am 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.

Thank you, Jenna, and good morning, everybody, and thanks for joining us. 2021 has been a pivotal year for TG, as we transitioned from a purely development stage company into a fully integrated commercial organization. With the launch of UKONIQ and the continued build of our commercial platform, TG has grown tremendously this year. I am incredibly impressed with the team we've built and excited to see everyone working so closely together for 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 in CLL and ublituximab in 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 Biologics License Application or BLA submission to the US FDA for ublituximab, 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 I and II Phase III 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 ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate, sometimes referred to as ARR, with ublituximab treatment resulting in historically low levels of annualized relapse rate. At the ECTRIMS 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 ublituximab 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’d 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 ublituximab 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 ublituximab for success in MS. Next, let's review the UNITY-CLL Phase III 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 UKONIQ, plus ublituximab, for those of you who are new, referred to as the U2 combination for treatment of patients with CLL. These applications were supported by the data from the UNITY-CLL Phase III 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 chemo immunotherapy. 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’ve built this year around UKONIQ 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 UKONIQ. As a reminder, in February of this year, the FDA granted accelerated approval of UKONIQ as a single agent 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 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 UKONIQ 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 UKONIQ in 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 UKONIQ prescriber base continues to grow. And importantly, we are seeing increasing uptick 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 outcome for patients and become future drivers of growth and expansion of our hematology oncology commercial platform. Starting with U2 plus venetoclax. As a reminder, the ULTRA-V Phase III trial evaluating this triple combination is now enrolling patients with treatment-naive and relapsed or refractory CLL. The Phase II 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 this Phase I U2-plus ven combination, which now includes approximately 47 patients treated with the triplet regimen. Best overall response of 100% among the evaluable 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 TG-1701, our investigational BTK inhibitor as a monotherapy and as a triple combination with U2. We were pleased to see that with additional patients, TG-1701 continues to show encouraging clinical activity 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 in 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 for ublituximab to treat patients with relapsing forms of MS. We also will continue to work with the FDA on the U2 BLA/sNDA for patients with chronic lymphocytic leukemia, which has a PDUFA target goal date of March 25, 2022. We plan to have an exciting ASH Conference in December and are looking forward to having a live presence there. As mentioned, in just a few minutes at 9:00 A.M., so that’s 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 UKONIQ in relapsed or refractory marginal zone and follicular lymphoma and expand our commercial footprint in preparation for potential future launches including U2 in CLL and ublituximab 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 venetoclax in both treatment naive and relapsed/refractory CLL and we plan to continue to advance our early pipeline candidates, including TG-1701, our BTK inhibitor that we've been talking quite a bit about, but some earlier stage compounds as well, including TG-1801, our anti-CD47, CD19 bispecific and TG-1501, our anti-PD-L1 antibody. With that, I am excited to turn the call over to our Chief Commercialization Officer, Adam Waldman to share some highlights from our early commercialization efforts. Adam?

Yes. 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 UKONIQ 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 our 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 impacts, we have looked at claims data, syndicated reports and spoken with providers directly and they all confirmed that patient visits and treatment initiations for patients with indolent 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 UKONIQ continues 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 a 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 UKONIQ 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. UKONIQ awareness and familiarity among targeted treaters remain high, and prescribers continue to cite strong UKONIQ performance across all key attributes. Again, we believe high UKONIQ awareness and foundational understanding of UKONIQ'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 UKONIQ, the TG teams and our patient support services and impressively, in third-party syndicated research, our field team is 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 UKONIQ is a launch strategic imperative. So hearing the positive feedback is particularly gratifying. Finally, based on market research, when prescribers understand the unique mechanism of action, 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 UKONIQ launch. As mentioned during our last call, we are seeing UKONIQ demand from patients who are facing drug affordability issues. And as a result, through our TG Patient Support Program, we have provided UKONIQ 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 are very pleased with the UKONIQ 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 UKONIQ is allowing our teams to establish strong relationships with cancer centers and healthcare providers while ensuring initial positive experience with UKONIQ and TG. 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, ublituximab, as part of the U2 doublet combination with UKONIQ and CLL early next year in the U.S. market, and believe our preparedness and our experience with UKONIQ 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 ublituximab 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 on the ublituximab profile has been very positive across the board, and our belief is there is a very compelling commercial opportunity here. In particular, neurologists view ublituximab efficacy and tolerability profile as impressive and highly competitive with existing CD20s. Ublituximab's shorter infusion and flexible premedication and post monitoring requirements demonstrated in the ULTIMATE I and II 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 the UKONIQ launch as utilization and experience at community and major cancer centers continues to grow and awareness of UKONIQ's profile continues to expand. We have also made significant progress preparing the organization to optimize the potential launch of U2 in CLL early next year and the potential launch of ublituximab in MS late next year. With that, I'll turn the call over to Sean.

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 & 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 UKONIQ 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 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 2021, 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 cost pertaining to our BLA filing for ublituximab in MS and an increase in CMC expenses incurred in Q3 of 2021. 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 UKONIQ and planning for the potential future launches of U2 in CLL and ublituximab in RMS. Our GAAP net loss for the third quarter of 2021, inclusive of non-cash items, was $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.

Thank you. Our first question comes from Alethia Young with Cantor Fitzgerald. Please proceed with your question.

Hi. Good morning, and thanks for taking our questions. This is Nina, on for Alethia. 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.

Sure. Thanks for the questions. So, in terms of ULTRA-V, the expectation is that we will have data probably middle of next year at conferences. So ASCO, EHA, maybe Lugano; that kind of focus is end of this year, but as we've discussed previously, 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 that and then Adam can chime in. For the most part, these patients are on Medicare. They are 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. The only ways for companies to really help patients with co-pays for those who 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 costs and even though it may be a small portion, they cannot afford it. 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. The vast majority of them have insurance; it's just they still can't afford the co-pays. Adam, did I miss anything there?

Yes. 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 a lot of support in lymphoma, but we do think the issue will have less impact on CLL because there is funding available there.

Thanks. That's helpful.

Thank you.

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

Good morning. Thanks for taking the questions. A couple from me, but first on UKONIQ, whether you saw any sequential shifts in gross-to-net versus the second quarter? And perhaps how we should be thinking about that into year-end. And whether at this stage as you look to expansion with U2 for CLL, is there anything you might guide at this point in terms of how to think about gross-to-net in the CLL setting? And then, perhaps as it relates to ublituximab for RMS— with your launch pre-commercial preparations underway—can you talk a bit about the concentration of the prescriber account base there? And coming away from ECTRIMS, what messages are resonating strongly with the treatment community and what impacts is relative price playing in your discussions with providers right now?

Sure. So Adam, why don't you take the gross-to-net questions for UKONIQ and what we might anticipate in CLL, and then we'll tag team on the RMS items.

Eric, thanks for the question. The gross-to-net is 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 rotation in 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 at this point, there hasn't been major shifts in gross-to-net. As for CLL, it's too early to give any insight on gross-to-net in CLL.

Got it. And then in terms of ublituximab and RMS, two-part question: concentration of prescriber base and feedback after ECTRIMS, including price impact. There are about 500 centers that represent approximately 80% of the MS patients; it's a highly concentrated market. From ECTRIMS and CMSC, the feedback has been very positive. People are excited about the one-hour infusion. They like the mechanism, the glycoengineering aspect, and they see it as a differentiated CD20. Regarding price, access is probably more important than price assuming price can be used to buy access. Providers want timely access for patients and want to be able to get patients on the drug they choose without long delays. Our payer team is actively working to cut through red tape to facilitate access, and if price is needed to secure access, we will consider price strategies to optimize access for ublituximab in RMS.

Great. Thanks for taking the questions.

Thank you. Our next question is from Ed White with H.C. Wainwright. Please proceed with your question.

Good morning. Question to start off for Adam. Can you comment on the 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 UKONIQ? Do they understand the differentiation and maybe if you can tell us some of the challenges that you might be seeing?

Sure, Ed. We were seeing increases in live engagements toward the early summer months. As the Delta variant picked up, live engagements declined as cancer centers reinstated COVID restriction policies. We are hopeful now that with the Delta variant subsiding, we are seeing pickup back into the fourth quarter. Live engagements are a more effective way of communicating, and while there's fatigue with virtual meetings, we still use digital channels. The challenges are that it can take multiple interactions for physicians to appreciate the full profile and to identify patients. We've increased our digital and non-personal efforts and developed innovative educational programs and speaker programs to address that. We've also increased investments in data to better identify patients and to target our outreach, which we view as an access tool to get to prescribers with relevant information.

Great. Thanks. Now a question on the European strategy. You had mentioned last quarter that you might target the MS before the hematology. Can you give us an update maybe on your European strategy and also your thoughts on perhaps partnering?

We haven't made any final decisions, but we are leaning significantly toward bringing MS forward first in Europe. Regarding partnering, we haven't made final decisions either. We are leaning toward a go-it-alone strategy but are keeping our options open.

Thanks, Mike. And a last question, perhaps for Sean. On R&D, you had mentioned the increase was due to the BLA submission and increased manufacturing cost. Should we be thinking of these as one-time in nature, and perhaps can you give your thoughts on what's the underlying run rate for R&D and how we should be thinking of it directionally for the fourth quarter and for 2022?

Sure, Ed. Ahead of potential approval for ublituximab, we may see some lumpiness in R&D as certain costs will run through the P&L ahead of being able to go on the balance sheet as inventory. Directionally for 2022, if you average R&D over the course of 2021, it's probably going to be pretty flat with maybe a little bit of an uptick towards the latter half of 2022.

Okay. Great. Thanks for taking my questions.

Thank you. Our next question is from Chris Howerton with Jefferies. Please proceed with your question.

Hi. Great. Thank you so much for taking the questions. Two from me: first related to CMC. With respect to heading into the PDUFA dates, what is the preparedness of CMC and supply particularly for ublituximab as it relates to both the CLL and MS application? As a follow-on, is there additional supply that will be required to serve the MS market when and if both indications are approved? And then, for Adam, as you look at the new patient adds from the community setting, what would you say is the impact of the site experience during the clinical trials that you're in?

Chris, on CMC preparedness and supply, we feel very good about our readiness and supply. We have a long-term supply agreement with a top antibody manufacturer and feel comfortable that we have plenty of supply for both oncology/CLL and MS launches. For MS on a volume basis, we don't use a lot of material and it's subsumed in our overall CMC agreement.

Chris, on the community new patient adds, the majority of the new patient starts are coming from sites that had experience participating in our clinical trials, so that experience has helped. We do see a large percentage coming from sites involved in the clinical development program, although community use is not exclusively limited to those sites.

Okay. Thanks a lot for taking the questions and I appreciate it.

Thank you. Our next question comes from Mayank Mamtani with B. Riley. Please proceed with your question.

Good morning team. Thanks for taking my questions. Two quick ones for Adam on commercial, and then one on ASH abstracts. On the pandemic going forward, is there like a pent-up demand dynamic that we should be aware of for any of the upcoming quarters? And then, on MS readiness, I was curious about infusion capacity and whether dynamics in neurology clinics such as the Alzheimer's drug launch are playing a role in your payer and access conversations within the team?

Mayank, it's difficult to predict; I wouldn't expect a large pent-up demand. As COVID subsides we should see increased patient flow gradually. On the Alzheimer's drug dynamic and infusion capacity, we do not think that will materially affect access for ublituximab in MS. The majority of MS patients are commercially insured and younger, so the insurance dynamics are different. We'll continue to monitor infusion capacity and access dynamics as we prepare for launch.

On the ASH abstract question, Mike, lots out there. Maybe distill where we should focus, and on your U2 plus ibrutinib abstract, can you remind us about TG-1701 discontinuation rates and median treatment duration where applicable?

On discontinuation, I have to double check the exact percentage, but discontinuation due to adverse events with TG-1701 has been very, very low. On ASH, we have a number of presentations: UNITY-NHL data including U2 in marginal zone lymphoma and some cuts in DLBCL; UNITY-CLL tertiary and post-hoc analyses; and the U2 plus ibrutinib abstract, which is an interesting design conceptualized to potentially allow patients on BTK inhibitors to achieve deeper responses with U2 and then take drug holidays off BTK therapy. It's a smart design and we are encouraged by the approach, but we'll see the data as it's presented. Overall, the ASH program showcases U2 as both a doublet and a backbone for triple combinations and highlights potential patient populations who may be poor candidates for BTKs due to comorbidities or concomitant medications.

Thank you, Mike. I look forward to additional details.

Thank you. Our next question is from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Thank you, good morning, Mike and team. First for Adam: can you talk a bit about the current status and size of the commercial organization? And how you expect it to evolve over the next 12 months as you head into the launch in CLL for U2 in March/April and then into the MS market in the second half of next year?

Sure, Matt. We have about a 70-person field footprint right now on the oncology side. We've made some opportunistic small expansions for CLL to reinforce areas where we needed reinforcement. Largely, the oncology footprint is in place for what we need for CLL. On the MS front, the market is more concentrated—about 500 centers seeing roughly 80% of patients—so a field footprint in the 80 to 100 representative range is typical for competitors and we are evaluating what that will look like for us. The UKONIQ launch experience will help inform our expansion plans.

Thanks. A follow-up for Mike: you mentioned U2 in DLBCL and some intriguing data. Any thoughts on potential next steps for development in DLBCL?

We are still putting that together and will evaluate the data closely. Step one is to get U2 approved for CLL. Step two is to consider supplemental filings and assess which data sets could support additional filings. We think U2 in marginal zone is a potential candidate for inclusion and we'll take a hard look at diffuse large B-cell lymphoma to see if it can be included in a filing as well.

Great. Thanks for taking the questions and congrats on the progress.

There are no further questions at this time. I would like to turn the floor back over to Mike Weiss for any closing comments.

Well, since the hour is late and the market is already open, I'll keep this quite brief and just thank everyone for joining us this morning and for continuing to support us. Have a great day. Thank you.

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