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. [Operator Instructions] 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 and CLL and ublituximab 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 Biologics License Application or BLA, submission to the USFDA for ublituximab. They're 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 with 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…

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 continue 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 growth in – that 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…

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.

[Operator Instructions] 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 conferences. So the ASCO, EHA, maybe, I think, Lugano, that kind of focus end of this year, or ASH, which now the abstracts are live as of 9:00 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 out and then if I missed anything, Adam can chime in. For the most part, these patients are on Medicare. They are - I hate to use the word elderly since I think I am approaching the average age of folks with marginal zone 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 to - for companies to really help patients with co-pays for – 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 costs and even though a 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 missed anything there? Yes, sure.

Yes. 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 it. There is not a lot of it in lymphoma, but we do think the issue will be largely less. It will have a 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, 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 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 sort of 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 ECTRIMS, what messages are resonating strongly, I think 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, if you could, help me out on the gross to net questions for UKONIQ and for what we anticipate in CLL and then we'll tag team on the RMS stuff?

Yes. 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 rotation 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. That was the first question. What was the second question? It was around...

Perhaps into...

Do you want to take the second question?

Yes. Well, just...

Yes, too early, yes.

CLL, right? So CLL, it's too early to give any insight on gross to net in CLL.

Got it, Okay. And then in terms of ubli and RMS two-part 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 patients. So it's a really highly concentrated in major centers here in the U.S. And in terms of things we heard coming out of ECTRIMS, I think you particularly wanted to understand how price may impact. The things that – so both from ECTRIMS, but as I mentioned in the prepared 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 is definitely attractive, particularly for all the patients and for any of the physicians that have infusion centers or associated with infusion centers, the one hour infusion is really something that's quite attractive. They really like the mechanism. A lot of people were digging in on the glycoengineering aspect of ublituximab. The different epitope finding sites. Definitely, people were understanding that this is a differentiated CD20, and that was generating a bit of excitement. And then, circling back to price, what we hear now consistently is that access is probably more important than price assuming we use price to buy access, price matters. But really it's a function of when they have an option for patients, they want to know that they get the patient on the drug that they choose and they want to get them on the drug quickly. They do say that – they do sometimes have challenges with OCREVUS and getting patients on in a timely fashion. So there is definitely room for improvement there. And 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 ublituximab in RMS. Adam, any additional thoughts?

No. Mike, I think you got it.

Thank you.

And great. Thanks for taking the questions.

Yes.

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? Are there - do they understand the differentiation and maybe if you can tell us some of the challenges that you might be seeing?

Sure, Ed. Great question. We were certainly seeing some increases in live engagements toward 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 are hopeful now that the Delta variant has gone down. We are 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 Hem/Onc 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. What we've done – I mean, the challenges that you asked about, yes, 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, getting in. Sometimes it takes, especially with the 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 the 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 we feel like if we can identify patients and know where to go. We can do some interesting things around better targeting, and we can use that as an access tool to getting to prescribers that have patients and the information is very relevant to them. So.

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 just give us an update maybe on your European strategy and also your thoughts on perhaps partnering?

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 are certainly leaning toward a go-it-alone strategy, but we're certainly keeping our options open.

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 cost. 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 directionally for the fourth quarter and perhaps if you're willing for 2022? Thanks.

Sure, Ed. Thanks for the questions. I think ahead of potential approval for ublituximab, we may see some lumpiness or some bumpiness in R&D as the CMSC costs will run through the P&L ahead of being able to go on the balance sheet as inventory. Directionally, for 2022, I would say, if you average the R&D for 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.

Thanks, Ed.

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. I guess, the two from me, first would be just, I guess, related to the CMC. With respect to kind of heading into the PDUFA dates, what is the preparedness of CMSC and supply particularly for ublituximab as it relates to both the CLL and MS application? 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, as you are kind of looking 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 are in? Thanks.

Yes. So Chris, I'll jump in on the CMC stuff. Yes, we are 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. And so, 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 yes, we feel very comfortable again that we have plenty of supply through that relationship for both the oncology and CLL and MS launches. Adam, did you follow the second question completely, because I personally did not? You got it.

I did, I did. Yes, I got it. So far, yes. So Chris, in the community and the new patient adds, yes, we're seeing, yes, 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 – we've said it before, I think that helped, and we are seeing that the use in the community it's not exclusively in those sites. But we do see a large percentage of these coming from sites that were involved in the clinical trials previously.

Okay. Well, thanks a lot for taking the questions and I appreciate it.

Thanks, Chris.

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. So two quick ones for Adam on commercial, and then I have ASH abstract. Since the abstracts are out now, I guess, you can talk about it. So before that – so, 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 for from relatives? And then, on MS readiness, I was just curious, this Alzheimer's drug dynamic in neurology clinics and even 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 payer and access conversation within the team?

Yes, sure. Yes. No, I wouldn't – on the pandemic, this stuff is just so difficult to predict how this is going to go. I wouldn't expect there will be a pent-up demand. I think that hopefully, as COVID starts to go down, we will see increased patient flow. And – but I don't think there is going to be a big patient pent-up demand. So I think it will slowly trickle in, and I think that will be generally a positive. I think as the COVID situation increases, that's generally a positive and we are optimistic for the future. As far as the second question goes, Mayank, on the Alzheimer's drug and that those dynamics on infusions in MS, the use is the – 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 ublituximab in MS. 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 have commercial insurance is the younger patient population. So, maybe it might be slightly different from a reimbursement dynamics than the Alzheimer's situation, although I am 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 a -just an insurance mix perspective. Hopefully, that answers your question.

Yes. And the capacity of neurology clinics may be helpful there, too. So, on the ASH abstract question, lots out there, Mike, if you can just maybe distill down on where we should focus on. And maybe the specific question I had was around your U2 ibrutinib abstract. Can you just remind me with your BTK, you do – what do we know about the median treatment duration? And where do we stand with the current discontinuation rate there with the ongoing study?

Yes. So just starting from there, I have to double check, but the discontinuation rate due to AEs is very, very low with TG-1701, very, very low. So, I don't have the percentage in front of me, but I know that discontinuation 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 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, because we'll be presenting on U2 in diffused large B-cell, which is kind of intriguing, some interesting information there. I think the presentation is coming together nicely. So that's the UNITY-NHL, submission guide coming there. We have some nice UNITY-CLL cuts of the data. Again, these are more tertiary and post-hoc analysis. One that I am obviously quite keen on is we've always said that there is this population of patients who may be poor candidates for BTK inhibitors based on co-morbidities or on con-meds, concomitant medications, that they need to be on. So we went back through our Phase III database to look at what percentage of the patients have co-morbidities that could make them poor candidates for BTK and others that are on medications that are contraindication – contraindicate 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 it really kind of just highlights that there is a need for novel therapies and U2 can really fit nicely into certain practice settings…

Thank you, Mike. I look forward to additional details as you guys think about the design. Appreciate you taking my question.

Thank you.

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

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 head into the launch in CLL for U2 in March, April, and then into, I guess, the MS market in the second half, third, fourth quarter of next year?

Sure, Matt. Thanks. So, we have about a 70-person field footprint right now on the oncology side and I think we've made some opportunistic expansions here for CLL that in small numbers that help reinforce the team in areas that we thought we needed some reinforcements and we are 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 are getting from UKONIQ 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 field footprint that is a reasonable size. I think most other competitors are in the 80 range on reps, 80 or so, 80 to 100 on the rep size and we're evaluating right now what that will look like for us. But I think you can use that as a reference for how you might think about the size of our team going forward.

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, outreach pre-approval, how is ublituximab 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? What are their hot buttons, I guess, that you are hearing back?

You want to go ahead, Adam? I think Matt wanted you to answer that one. Although I could answer it, Matt, though I'll let Adam...

Why don't you start, Mike, because you were down there? You were at the ad board last week. So why don't you start? I'll fill in.

You're being super polite. You were there as well. But, yes, 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 at live about two weeks ago in Orlando. Yes, I think people are very impressed with the activity level of the compound. Again, what I've been saying for a long time, some folks are completely convinced it's a better activity profile and others are bucketing it 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 I think most people would say on par or better from an efficacy standpoint. I think overall, people are excited about the infusion times and the associated infusion-related reactions. I think when you talk to folks, OCRE 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 we are actually quite comforted by it. So I think all systems are go from what I could tell. Again, I think key attributes, the activity profile, safety, everything has got to be in line and should do better, and I think that's where people perceive it. And then, the hour infusion is extremely attractive and – but the big one, as I mentioned earlier, is all about access, right? So to the extent we can drive great access, 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 as 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.

Great. Thanks, Mike and I guess, one last question. Mike, you mentioned in your kind of walk to ASH abstract highlights, U2 and DLBCL and some new data there being intriguing. Any thoughts on potential next steps with the development for DLBCL?

We are still just putting that all together in terms of the data. But, yes, 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 – fully evaluating, which data sets could be part of that supplemental filing. We think U2 marginal zone is certainly a potential candidate for inclusion in that kind of a filing as well. And yes, we'll take a hard look at the diffuse large B-cell and see if we can include that in a filing, too.

Great. Well, thanks for taking the questions and congrats on all the partners.

Thanks, Matt.

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.

Well, since the hour is late. Market is 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.

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