Greetings, and welcome to the TG Therapeutics third quarter earnings conference call. 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. Thank you, Jenna. You may begin. Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the third quarter 2022 financial results and provide a business update are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercial Officer, and Sean Power, our Chief Financial Officer. Following our safe harbor statement, Mike will provide an overview of our recent corporate developments. Adam will provide an update on our commercialization efforts, and Sean will provide a brief overview of our financial results before turning the call over to the operator to begin the Q&A session. Before we begin, I'd like to remind everyone that we will be making 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 operating 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. 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 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. Now, I'd like to turn the call over to Michael Weiss, our CEO. Thanks, Jenna, and good morning, everyone, and thanks for joining us on the call. The third quarter of 2022 was a very productive time for TG as the team really came together to execute on our pre-launch commercialization plans. As we've mentioned previously, our goals for this year are to work toward an FDA approval for ublituximab in relapsing forms of multiple sclerosis and to be prepared, if approved, to launch early next year. We've guided that our goal was to dedicate the resources necessary to achieve these goals and minimize or eliminate all other expenses. I'm pleased to report that our streamlining and focusing efforts have been extremely successful in reducing our overall burn while reserving our resources to support the potential approval and launch of ublituximab. Sean Power, our CFO, will join us shortly on providing additional details, but our burn for the third quarter was approximately $34 million, down substantially from prior quarters. I'm proud of the hard work and team effort that was required to realize these cost savings while ensuring we were all well-positioned financially for the potential launch of ublituximab. Also, in just a few minutes, Adam Waldman, our Chief Commercial Officer, will join us to provide more details around our launch planning and progress, which from my vantage point seems to be moving along quite nicely. We believe that if approved, ublituximab has the potential to play a meaningful role in the treatment of multiple sclerosis. We remain committed to offering patients a highly active treatment option with the convenience of a 1-hour infusion administered every 6 months following the first dose. With that, let me remind everyone of our phase 3 program that is supporting our BLA submission for ublituximab in relapsing forms of MS, also referred to as RMS. The ULTIMATE 1 and 2 phase 3 trials evaluated ublituximab compared to teriflunomide, enrolling approximately 1,100 patients across 10 countries and were led by Lawrence, Dr. Lawrence Steinman of Stanford University. As noted in the past, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate. It's also referred to as ARR, compared to teriflunomide. In addition to the positive primary endpoint results, we've had the opportunity over the past year to present several different sub-analysis of this data set, which we believe continues to show an encouraging profile for ublituximab for the treatment of patients with RMS. Most recently, we had the opportunity to present 5 additional exploratory data sets at the 2022 Annual Congress of the European Committee for the Treatment and Research in Multiple Sclerosis, commonly referred to as ECTRIMS. The team engaged with numerous KOLs during this meeting, and the feedback we received around the profile of ublituximab was highly encouraging, and we believe the data presented further support the potential for ublituximab to treat patients with RMS if approved. Now on the regulatory front. As in the past, we will not provide color on any interactions with the FDA, but we would like to provide an update on where we are in the process. With less than 2 months to the target PDUFA action date of December 28th, 2022, we can confirm that we have completed the late-cycle meeting and labeling discussions have recently commenced. We remain hopeful that ublituximab will be approved, and if approved, we'll be excited to make ublituximab available to the many patients with RMS that are in need of additional treatment options. I will also mention that our efforts with the EMA for EU approval are moving along. From a timing perspective, potential approval could occur in the second half of 2023. We are still assessing the go-to-market strategy in Europe, and we continue to evaluate whether to go it alone or whether to partner ex US. With that, let me turn the call over to Adam Waldman, our Chief Commercial Officer, to share some thoughts on our preparation of the past quarter, as well as his thoughts on the potential commercial opportunity and plans for ublituximab in RMS. Adam? Thank you, Mike, and good morning, everyone. I'm excited to provide an update on our commercial activities as we have made considerable progress over the last several months on our preparation for the anticipated ublituximab launch in relapsing forms of multiple sclerosis. MS is a debilitating chronic disease that can have a significant impact on the quality of life of patients and their families. The CD20 class has truly transformed the way MS is treated, and physicians believe that using these agents early may significantly impact the natural course of the disease. Today, approximately one of every 2 patients starting a new therapy will go on to CD20. In fact, market data shows that in the second quarter of 2022, there was the highest share of CD20 usage we have seen since these agents were launched. This is a large and growing market, and based on our market research, we believe ublituximab has the potential to capture meaningful market share. We understood from the moment we started working in this space that one of the keys to success would be to hire a team of MS-experienced professionals with a deep knowledge of the landscape and strong relationships across the MS community. To that end, we have been methodical in how we have hired our commercial field teams and have hand-selected people that fit our target profile. Over the last several months, we have significantly ramped up our hiring, adding critical field-based customer-facing roles in sales leadership, and access and reimbursement support. Our hires on average have 12+ years of MS industry experience. They've joined our previously hired field-based regional marketing team, as well as our payer and medical teams, which have been engaging providers and payers for the last 12 months. At this point, we have met our internal hiring goals for our field-based team members, and we will be working over the next several weeks to finalize the hiring and training of these teams to be prepared for launch. Our team also knows how important it is to get this drug to the patient community and is working hard to ensure we do everything we can to provide access to ublituximab once approved. One of the biggest frustrations we hear from physicians and practices in general is navigating the process of access and reimbursement for therapies. We have therefore placed a significant emphasis on ensuring that the process to access ublituximab will be as seamless as possible. I'm extremely proud of the progress our team has made over the last several months building our capabilities in this area. First, from a payer perspective, our national account teams have been doing a great job engaging with national and regional payers for over the last year. Feedback on the clinical profile of ublituximab has been positive, and we do not foresee any major issues with reimbursement. However, with any new product, payers will need to work through their processes over the first 90-180 days post-launch. Second, we have made considerable progress understanding the institutional formulary process and have plans in place to work with the key MS centers of excellence to include ublituximab on their formularies as soon as possible. Third, we know the majority of MS patients will opt into patient support programs and that this is another critical component of ensuring access. We have worked very closely with key customers to build what we believe will be a best-in-class patient support program, and we are on track to be ready to launch this program alongside ublituximab once approved. Lastly, we have now hired an experienced field-based access and reimbursement team that will work with accounts to facilitate access to ublituximab. In summary, we have made tremendous progress on building and strengthening our commercial capabilities over the last 12 months, which has accelerated over the last few months as we ready the organization for the possibility of an ublituximab launch. We have built an incredible team, which we believe is as experienced, if not more so on a pound-for-pound basis than any MS team in the industry. These teams are ramping up their activities, actively engaging key participants in the MS community, KOLs, community neurologists, payers, and advocacy groups at conferences, advisory boards, and other engagements. Our confidence continues to grow as the feedback on ublituximab's profile and the way we have built our commercial team has been very positive across the board. We believe this launch represents a significant commercial opportunity, and all of our attention, focus, and commercial resources are aimed at making this a success. We continue to move forward with a sense of urgency and purpose as we know ublituximab, if approved, will be an important new option for patients managing this debilitating disease. With that, I'm gonna hand it over to Sean. Thank you, Adam. Thanks, everyone, for joining us this morning. Earlier, we reported our detailed third quarter 2022 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 $198 million in cash equivalents, and investment securities. That, coupled with the additional capacity available under our Hercules facility upon ublituximab approval, we believe will be sufficient to take us into 2024. We are pleased to report that our burn for the third quarter of 2022 came in under our previously guided range of $45 million-$50 million, landing on approximately $34 million for the quarter. Also well below prior quarters, which, as Mike said, is the result of our determined cost savings measures and our focused preparations for the upcoming launch of ublituximab, along with some timing differences which we will incur in future quarters. Our GAAP net loss for the third quarter of 2022 was approximately $36 million, or $0.26 per share, which was a decrease of almost $50 million from Q3 of 2021, where we saw a net loss of approximately $86 million, or $0.65 per share. As compared to the prior year quarter, the decrease was driven by across the board decreases in R&D and SG&A, primarily due to a streamlining of our oncology operations and a shift in focus to our MS development and launch preparation efforts. The GAAP net loss for the nine months ended September 30, 2022 was $145.3 million or $1.08 per share, compared to a net loss of $254.8 million or $1.93 per share for the comparable quarter in 2021, representing a decrease in net loss of more than $100 million period-over-period. In terms of what we expect moving forward, we project our burn for the fourth quarter of 2022 to be between $40 million and $50 million, which we believe leaves us well positioned through the anticipated MS PDUFA at the end of the year. With that, I will now turn the call back over to the conference operator to begin the Q&A. Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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 is from Ed White with H.C. Wainwright. Please proceed with your question. Good morning. Thanks for taking my questions. Just on the you had mentioned the EMA timing is the second half of 2023. Can you describe the opportunity in Europe? What is the market like? What are your expectations for it? As far as partnering, if you're going to partner, when should we expect to hear something like that? Would that be prior to approval, do you think? Or that would be something that would come after approval? Hey, Ed, thanks for the question. so the EU opportunity is interesting. I think the EU currently probably represents about 20-ish% of the overall market opportunity for CD20. So that's. It's a reasonable size piece of the market, but it's not obviously a large portion, so it's not a high focus for us. Most of that in terms of dollars is in Germany. The other countries, obviously they're in there, but it's a lot less. So, as we think about the opportunity and we think about potentially setting up an organization in Europe, I think it probably would be Germany focused and then we'd spread out from there if we did it on our own. In terms of timing of a partnership we're not providing any timing, but you know, it could happen before, after we launch there. It's always always very speculative. I would say again, if our ultimate decision is to partner to launch, then it invariably would happen in advance. Okay. Thanks, Mike. You've done an incredible job on cost cutting. I'm just thinking about how should we consider R&D expenses going forward. You gave some guidance on SG&A being up in the quarter. You know, what are the R&D opportunities? How should we be thinking about that? How should we be thinking of the expense for that line? Yeah. I would expect that the R&D expenses will continue to go down. Again, we still have oncology trials that are just far from completely shut down. So we're carrying some of those expenses still. As they continue to go down, we will be starting additional studies around ublituximab and MS and potentially outside of that. I think it continues to go down for the next quarter or two, but maybe Sean wants to chime in, and then it probably starts to creep back up in the second half of next year. Sean, is that about right or any other color? Yeah. No, I think that's fair, Mike. 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. Great. Thank you so much. I just wanted to ask a couple questions on kind of the expected commercial dynamics. You know, ofatumumab has been doing a little bit better in the launch, so I was curious how you were thinking about the differences between dosage forms in the CD20s and maybe if there would be some differential patient or physician targeting between those two. That would be one question. The second question I have is just a kinda housekeeping thing. As I was looking at our model, what is the latest kind of IP expiry that you're expecting, Mike and team? Thank you so much. Sure. On the IP side, I think the patents for rituximab, the basic patents are, with patent term extension, 2032, 2033. Assuming there is an approval, we'll be entitled to 12 years market exclusivity for biologics. That would actually put us into 2025 or very, very late 2024. I'm sorry, 2034, late 2034 or early 2035 for the 12 years. Sorry. Sorry about that. We do have some other patents we haven't spent much time talking about that could go on for another five, 10+ years. We think we've got a pretty good runway with the patents, with the biologic exclusivity and potentially some other patents behind the scenes. I will briefly answer your first question, and I'll let Adam discuss it. You know, it's interesting in terms of the dosage forms. It's really become somewhat two markets. I think the physicians, the prescribers, view these products somewhat differently and in different settings in which they might wanna use them. Most doctors and most patients actually heard yesterday in one-on-one engagements that even most patients are just not interested in dealing with their disease once a month. It does seem that the subQ has a nice role for patients who travel distances to get to their MS provider. You know, we had projected early on that subQ would probably represent about 30% of the market. It does feel like that's where they're capping out their. Obviously, their overall market share continues to grow because, as you know, there's an accumulation effect. As people come on, they stay on. Their dynamic share is getting close to capped, and I think it's between 25% and 30% of the dynamic share. That's kinda where we see the market. We believe it's gonna continue to shake out. About 70% of the patients will continue to receive an IV CD20, and about 30% will go with the subQ. Adam, please add some more color. I think you pretty much covered it, Mike. The only thing I would add is that it does seem like the market, with Kesimpta's launch, has continued to expand, perhaps outside the centers of excellence and more rural areas and perhaps more general neurologists. What Mike said is pretty much exactly what I would've said. Okay. Maybe just as a minor kind of follow-up, if you'll entertain it, Adam, and then Mike too, of course. I guess, how are you thinking about targeting those physicians that would be more likely to prescribe IV versus subQ, I guess? Do you have that visibility, do you think? Yeah. Adam. I mean, you know. Yeah. I'll start, Mike, and we can add. You know, I think MS centers of excellence that have infusion capabilities, I think community practices that have infusion capabilities would be a logical place to start and makes sense in terms of you know, where we think IV usage will predominantly continue to be. I think the majority of Ocrevus use is seen in those large MS centers of excellence and these very large community centers with infusion capabilities. Yeah. Thanks, Adam. I'll add to that, Chris, that when we think about the best or highest ROI for us, obviously it's going after those sites that Adam has referred to. The general neurologist is just, I think, getting into CD20s, and that's, I think, been a huge effort of both the Roche Genentech and Novartis teams to get out there. I do think, again, as Adam mentioned as they're pushing into the more rural environments, I think those are gonna be nice areas for something like Kesimpta, where they may be far from their physician. And general neurologists, again, who don't have infusion capabilities, might be an interesting place for something like Kesimpta. For us, the vast majority of the business and the vast majority of the current Ocrevus business, I think close to 80%, is still concentrated in those large centers of excellence and large community practices. Okay. That sounds excellent and a more efficient business model it sounds like too. Thanks, guys. Yep. Thanks, Chris. Thank you. Our next question is from Matthew Kaplan with Ladenburg Thalmann. Please proceed with your question. Hi, thanks for taking the questions and congrats on the progress, guys. Thanks, Matt. Just wanted to take Chris's question a little bit more forward. Can you comment on, I guess, Roche's subcutaneous programs and their high dose program as well? How do you think those will impact the market other than what you said? Yeah. I'll go first, Adam, you can chime in. You know, we don't know a ton about those programs. I mean, we know some certain timing. Potentially, I think the subQ could be available in the next 2 years, give or take. On the high dose, we don't really have any good visibility into where they are with that other than to say that. You know, I think their high dose strategy is to try to you know, comp off of our potentially perceived better activity with a more you know, potent CD20. We'll see how that works out for them. Again, I think it's gonna take them a long time to get the material into the patient, so I don't know that that's a strategy that's gonna provide a lot of additional competitive advantages for them. The subQ side, again, I think the jury's out. I don't think we're overly concerned about it. I think a one-hour infusion every six months is still an extremely convenient way of delivering the product. The subq I think there are issues with that subQ formulation. I mean, it's been used in a number of other products, some of which have been very successful, others have been not so successful. So I think the jury is out on that, and we'll see how it goes for them. Adam, anything further, any color? Yeah, I think you covered it, Mike. You know, I think we will wait to see what the actual profile of that looks like and what's required from a pre-medication, post-monitoring. You know, that all adds time and. I think what's interesting is that we do believe convenience, streamlining the experience does matter in this market, and it's an important aspect of the overall experience, both from a patient perspective, from a convenience, but also from an office perspective. We believe convenience is important, but we also continue to believe that we'll be best positioned for patients who want a quick one-hour, twice-a-year B-cell therapy. Okay. Thank you. You mentioned that you know plans for continued development of ublituximab. F ollowing approval, can you talk about your plans for PPMS, aggressive MS in the future? Yeah. We are exploring that area. I don't think we have any plans to discuss today, but we've certainly been engaging with KOLs to understand what the needs are and what they think would be a successful trial design in that area. Okay. Last question, I guess maybe for Adam. I guess following approval, what will your commercial team look like in terms of the size, the footprint and from where it is now? Yeah, thanks, Matt. We're pretty much in good position at this point. As I mentioned in our prepared remarks there, we've hit our internal timelines for hiring. I think what I've said in the past is that our footprint from a field-based perspective is about 80-100 people. We feel like this is, as we were talking about with Chris there, we think somewhat of a targeted approach. We think we know where we have to go in order to get the business. MS centers of excellence, large community centers is gonna be our focus. We think we have a team that will be more than adequate to cover that. We're in a good position right now, and we'll be ready for launch and come early next year. Great. Thanks a lot, and good luck going into December. Thanks, Matt. Thank you. Our next question is from Eric Joseph with JPMorgan. Please proceed with your question. Good morning. Thanks for taking the question. Can you just expand a little bit on your access strategy from the patient perspective? I'm just curious to know if there's much opportunity to compete with Ocrevus and Kesimpta when it comes to copays borne by the patient. Would also be curious to get your latest sense of how sensitive payers are to price. Finally, just on cash position, and you know, Sean noted being capped through 2024. I'm just wondering whether you're considering any financing alternatives to support the launch, perhaps a royalty monetization. Thanks. Thanks. Adam, you wanna take the first question? Sure. Yeah, thanks, Eric. I think we're gonna compete very well from a patient access perspective. As I mentioned, we've built a best-in-class patient support program. We will have all of the support initiatives that these companies have. You asked specifically about a copay program. We will have a copay program. We feel that we're in a good position to support practices and patients. Your second question was around payers and sensitivity to price. I think what we've heard is that payers are interested in inviting competition into the market. They're looking for lowest net cost. You know, I think they are sensitive to. I would just say low net cost. I think we've gotten feedback from them. We understand where they're at and have developed an idea of how we wanna price this, going into the launch. Great. In terms of cash position and alternative financings, I think, Eric, we're keeping all the doors open in terms of ideas on how we want to continue to add. But we're not gonna be in any rush. We have plenty of money to launch on day one. Obviously, with money into 2024, so not an emergency situation. Obviously, we're not overfunded, but most of that money will be sitting in the bank anyway while we're getting everything up and running. I think we're feeling quite good about the cash position, even though it may not look like a whole lot to others. You know, we're expecting to drive some revenues in the first year, which will also extend that 2024 burn number. We have plenty of options. Yes, royalty monetizations are on the table, of course, as our other potential financings, depending on the market conditions when we get to the launch phase. Great. Thanks for taking the questions, and also good luck into December. Appreciate it. Thanks, Eric. Appreciate it. Thank you. Our next question is from Mayank Mamtani with B. Riley. Please proceed with your question. Hi, good morning, team. This is Sahil Kazmi asking a couple questions for Mayank. What are your expectations for the potential labeling interactions as we're getting closer to the PDUFA date, and how the warning section could be differentiated from Ocrevus, for example? Yeah. Thanks for the question. In terms of we did disclose earlier that the labeling discussions have commenced, but that we're not gonna provide any further color, so I don't know that I have anything more to add. Same thing as it goes to the second part of your question. Okay, great. Just on the recent ICER report that came out, just any of your kinda top-line thoughts on how you're navigating through some of the payer discussions more broadly, maybe for Adam as well. Yeah. I'll lead off, and I'll let Adam take over. The ICER report we've obviously been reviewing and continue to review it. We'll probably have some comments on it, official comments at some point soon. Generally speaking, look, ICER's role is to try to influence how we price the drug. There's a clear reason why they put the report out before we launched. I mean, the whole report was all about, in my opinion, getting us to try to affect how we think about pricing. As you know, we've always been thinking about coming in at a lower price point. It's not foreign to us the concept, but I think some of their analysis are skewed and certainly just to make a point. I'll let Adam maybe address the overall payer access environment. Yeah. I think with regards to the ICER report specifically, I mean, our view is that we don't think it's gonna affect our access. You know, payers haven't really reacted to it. We feel good about the value proposition we're bringing with ublituximab and feel good about our payer strategy and what we're thinking about from a pricing perspective and feel confident, as I mentioned in the remarks, that we don't foresee major issues with reimbursement and coverage. Excellent. Thanks a lot for taking our questions, and best of luck for the PDUFA. Thank you. Thank you. Our next question is from Prakhar Agrawal with Cantor. Please proceed with your question. Hi. Good morning, and thanks for taking my questions and, congrats on all the progress. Firstly, a quick clarification. If you can remind us if there are any inspections left for the FDA? Also if you could talk about your readiness in terms of drug supply at launch. I had a follow-up. Yeah. Again, we haven't provided any color on inspection, so I'm gonna pass on that question. What was the second part? Readiness in terms of drug supply at launch. Oh. Yeah. Yeah, we have plenty of drug supply for launch. We have a large manufacturing arrangement with Samsung Biologics, and we're comfortable with our launch supply. Okay. Secondly, Mike, you mentioned you presented the data several times over the past few months. Talk about what you're hearing from specialists on what really gets them excited about ublituximab, some of the key factors, and also what's their willingness to switch loyalty from Ocrevus? Thank you. Sure. Thanks for the question. You know, when we go around and talk to the physicians, I think our goal is to just present the data as it exists. We think the data speaks for itself. What we find is that different clinicians will resonate toward different aspects of the dataset. Some folks will look at the annualized relapse rate, and we don't compare to other drugs in the class or other drugs outside the class other than teriflunomide. Many physicians will look at it and say, "Well, this is by far the best annualized relapse rate, and I want to have the best for my patient." They believe that this is the best. Others will look at the data, and they'll be impressed with the tolerability and speed in which we can deliver the infusion. It's not just about the one-hour infusion, it's about the consistency to deliver a one-hour infusion and the tolerability. Ocrevus continues to have in later lines of infusion relatively high rates of infusion reactions upwards of 20, 25%, even as of the third or fourth infusion. Where we're down by the third infusion, I think we're around 5% or something. It's, I think tolerability is one people have resonated toward. Again, we don't compare. We don't make the comparisons, but the folks will do their own comparisons in their head. Then the one-hour infusion, obviously from a patient convenience standpoint, a practice convenience standpoint, a lot of folks will resonate toward the one-hour infusion. I think it's a mixed bag. Our job is just to make sure we present the facts and only the facts, and folks will do their own internal assessments of how they view the data. Thank you, and looking forward to the update in December. Thank you. Thank you. There are no further questions at this time. I'd like to hand the floor back over to Mike Weiss for any closing comments. Great, thank you. Thanks everyone again for joining us this morning. As discussed multiple times today, on this call, with the target PDUFA action goal date of December 28th, our primary focus is and remains working toward an approval for ublituximab for patients with relapsing forms of multiple sclerosis, and if approved, being prepared to launch early next year. Again, if approved, we believe ublituximab could be a meaningful treatment option for patients with RMS. We believe treatment options are essential when it comes to treating chronic illnesses like MS, and we are committed to supporting the MS community. Thanks again for joining us this morning and have a great day. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.