Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2023 Financial Results and Business Update Call. At this time, all participants are on 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. Thank you. Please go ahead.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and year-end 2023 financial results 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, Adam will share an update on our commercialization efforts, and Sean will give an 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, revenue guidance, development plans and expectations for our marketed 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 filing. 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 later date. We specifically disclaim any obligation to update or revise any forward-looking statement. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

Thanks, Jenna, and good morning everyone. Thanks for joining us on today's call. 2023 was a transformational year for TG. We kicked off the year with the launch of BRIUMVI for relapsing forms of multiple sclerosis toward the end of January and saw a nice sales momentum carried throughout the year, resulting in approximately $90 million in U.S. BRIUMVI net revenue for our first partial year of sales. We believe these first-year revenues speak to the high level of early interest and strong underlying demand for BRIUMVI, and we look forward to continued carry-through in 2024, where we are targeting $220 million to $260 million in U.S. sales revenue. The feedback from physicians, patients, nurses and infusion centers continues to be very positive, and drives our confidence in both the short-term revenue ramp, as well as the long-term blockbuster potential of BRIUMVI. Our team remains focused on our ultimate goal of becoming the number one prescribed CD20 by dynamic market share perspective, and the early uptake supports our belief that that is possible. Having said that, this is a competitive market and BRIUMVI is the newest entry, so differentiation matters. One obvious difference is that BRIUMVI is the only anti-CD20 monoclonal antibody that can be given as a one-hour infusion every six months after the starting dose, which may be an attractive profile for both patients who want to get back to their daily lives and for healthcare practices seeking to increase the efficiency within their infusion suites. Beyond the one-hour infusion, we are excited to continue to explore biological-based differences that may not be as readily apparent, but are perhaps clinically relevant. As a reminder, BRIUMVI is differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. Preclinical data demonstrates that compared to…

Thank you, Mike, and good morning everyone. I'm pleased to share with you the results from the fourth quarter and cover the highlights from our BRIUMVI commercial launch performance in 2023. Launching BRIUMVI last year was a transformational event for our company. We've built a strong commercial infrastructure that delivered exceptional results, exceeded expectations on the launch, and now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. And more importantly, we made a positive difference in the lives of thousands of people living with MS. As reported at the JP Morgan Conference last month, fourth quarter net sales for BRIUMVI were $39.9 million, representing 60% growth quarter-over-quarter and bringing our full year 2023 revenues in at $89 million. The fourth quarter number exceeded our guidance and reflects the growing demand we are seeing for BRIUMVI. We saw an increasing number of repeat prescribers and incremental gains in new prescribers and new centers adopting BRIUMVI. We also started seeing increasing prescribing from major academic centers in the fourth quarter as the logistical barriers at these centers continue to decrease. In fact, the fourth quarter was the first time we saw more scripts from academic centers than in a private practice setting, which we view as positive progress given that 60% to 65% of patients are being seen by MS specialists in the academic setting, and this has been a focus for our team as we headed into the end of the year. Overall, in 2023 we saw approximately 3,200 new patient prescriptions come through our hub, which we believe translates into about 3,500 total new patient scripts as not all new prescriptions will come into our hub. We're also pleased to see a wide distribution of use…

Thank you, Adam, and thanks again to everyone for joining us. Earlier this morning we reported our detailed fourth quarter and full year 2023 financial results, which can be viewed on the investors and media section of our website. This morning, I'll start with a discussion of our revenue for the fourth quarter and full year of 2023. As previously mentioned, we are pleased to report U.S. BRIUMVI net product revenue of $39.9 million during the fourth quarter. Also included in our total net product revenue for the fourth quarter is approximately $3.2 million of revenue for products sold to Neuraxpharm in support of the ex-U.S. commercial launch, and $800,000 of other revenue, taking total revenue for the fourth quarter to approximately $44 million as reported. For the full year, we reported total revenue of approximately $234 million, which is predominantly comprised of $88.8 million in U.S. BRIUMVI net product sales, $140 million in license revenue stemming from the upfront payment for our ex-U.S. commercialization agreement with Neuraxpharm, and $3.2 million in product revenue for products sold to Neuraxpharm, as previously mentioned. Our OpEx during the fourth quarter and full year has remained well controlled and in line with previously discussed ranges. For the fourth quarter and full year 2023, our operating expenses were $56 million and $213 million respectively, which includes COGS of $7.8 million and $14.1 million in the respective periods. When excluding on cash compensation, our cash operating expenditures during the fourth quarter and full year 2023 were approximately $47 million and $175 million respectively. On the back of the reported revenues and well-controlled OpEx, we were able to report net income of $12.7 million or $0.09 per diluted share during the full year of 2023. For the fourth quarter of 2023, we reported a net loss of $14.4 million or $0.09 per diluted share. And finally, from a cash standpoint, we ended the year with approximately $217.5 million in cash, cash equivalents and investment security. And we believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations to cash flow positivity. With that, I will now turn the call over to the conference operator to begin the Q&A.

Thank you. The floor is now open for questions. [Operator Instructions]. Today's first question is coming from Michael DiFiore of Evercore. Please go ahead.

Hi. This is Jessica on for Mike. My first question is, in the past you guys have said that you've heard anecdotal reports of patients not petering out in the days and weeks leading up to their subsequent BRIUMVI dose, which is not always the case with competitor anti-CD20s. So what's been the feedback on this front, and how much do you see BRIUMVI's consistent treatment duration as a key differentiating factor? And then also, if I can sneak in another question, what can we expect on growth-to-net cadence for the balance of the year? Thank you.

Got it. Thanks for the question. Adam, you want to field the first one, and then I'll have Sean take the second.

Persistence, I assume you mean the discontinuation rate for patients going from first or second infusion to third infusion. As you know, it's still early, but what I said in my remarks is true so far that the trends seem positive and around what we expected based on what we saw with the other IV CD20. So it's right in that range. I don't have any information right now to say that it's better. I certainly don't have any information to say that it's worse, but its right where we expected and we'll continue to look at it. Certainly if it's more positive than we think, certainly that will be an accelerator going forward.

Hi. And on the growth-to-net front, we have not provided going forward guidance on what to expect. There will be some variability quarter-to-quarter, but again, we haven't provided precise guidance on what 2024 will look like.

Great. Thank you.

Thank you.

Thank you. The next question is coming from Ed White with H.C. Wainright. Please go ahead.

Good morning. Thanks for taking my questions. So, just wondering if you have any numbers on the switches from prior therapies and how that's impacting your sales growth.

Yeah. So I'll start there and Adam can jump in. We haven't provided anything new. I mean, what we've said previously and it still holds true, is that in terms of distribution of patients, we see about – we have three buckets. Just to be clear, there's patients that are naive to all treatment. There's patients that switch from non-CD20 products to CD20, so there's the non-CD20 and there's the CD20 switches. What we've said is that the largest group coming on to BRIUMVI are those that were naive to CD20, but were pretreated with something else. And then the other two buckets, while they are not equal to each other, are relatively similar and they are reasonably close to the first bucket. So there's usually – there's a nice distribution across all the buckets.

Okay. Thanks Mike. And on Europe, congratulations on getting the launch in Germany. Can you give us your thoughts on the launch in Germany and in other countries and perhaps the cadence of future milestone payments?

Yeah. Adam, you've been a lot closer. You want to take a crack?

Sure. Hi Ed. So yeah, as you know and as we've spoken about before, getting BRIUMVI launched in Germany was really important. It's the biggest market by far in Europe. So getting that going out of the start was important and we are right on track with that, which is great. The other countries will start to come in the later part of this year into next year, including the UK, France, Spain, Italy, and they are continuing to work with the reimbursement authorities and getting through the process they need to in making sure the drug can be accessed. They are working diligently on that. They have a lot of experience doing it and will continue to work through the process. But Germany is by far the largest opportunity and the one that we prioritized first.

Yeah. And then just on the cadence of future milestones, we are not expecting any additional milestones this year. There's a chance we would see a milestone toward the end of next year, an additional milestone, but we'll get more on that later. But I wouldn't expect any additional milestones this year. As we reported to Morgan, obviously it's a launch year for these folks and we're not expecting a whole lot in royalty revenues as well.

Okay. Thanks Mike. And just lastly, Adam had mentioned adding to the sales force and expanding your reach. How should we be thinking about that as far as the growth or the ramp of SG&A expenses? Are you currently adding? Is this something that we should see in the second half of the year or just any guidance that you can give us on how you are expanding your sales force?

Yeah. So I'll chime in and Adam and Sean could jump in afterwards. Yeah, so as it stands today, even in the fourth quarter, some of that expansion -- actually most of that expansion is already included of the current expansion process. So it's already probably built in most of it into the fourth quarter and there'll probably be a little bit more that trickles into the first quarter. And then it's possible over the course of the year, there'll be a slow additional build. But most of its already incorporated and for sure it's incorporated in our OpEx estimate of approximately $250 million for the year. So that's all built in to what we are guiding already.

Okay. Thanks Mike.

You got it, Ed. Thanks.

The next question is coming from Roger Song of Jefferies. Please go ahead.

Hi. This is Con Bizon [ph] for Roger. Hi, Mike and team. Good morning. What timeframe do you think it's possible to achieve the number one prescribed IV CD20 for BRIUMVI by dynamic share? And as a second question, are there any remaining gating factors for you to enter the human bioequivalence studies for subcu formulations of BRIUMVI there?

Yeah, you broke up a little bit at the end there, but I think I got it. In terms of timeframe to be number one, we haven't set a timeframe yet, so I can't share one. It's a goal that we have and we're going to keep working toward it. But certainly as we get further along, I mean, I don't anticipate ‘24 will be the year that we do that. So I think that's pretty sure about that, but we are working toward that and we'll keep you posted. In terms of the subcu development, we do have our preliminary subcu formulation that we want to take into the clinic. We don't think that there's anything in our way to do that. We've got some filings to do, but it should be pretty straightforward, and we're hoping to have patients on, hopefully by mid-year.

Excellent. And then maybe as a couple of follow-up questions, is there any preparatory work required to enter BRIUMVI into studies outside of MS? And as a last question, we've noticed there's still a small number of scripts in third-party trackers. Some investors are still curious about the trends. Maybe we could put this topic to bed for once and all. Do you see any value at all in a third-party script tracker going to data?

Yeah, I would certainly love that. Adam, you want to hit that one on the third party?

Yeah sure. From what I understand, Roger – or it wasn't Roger, but – sorry. So what I understand is, the data you are seeing is SP data, which is a very small portion of our business, less than 10%. So yes, to put it to bed, I would say it is absolutely not something I would look at.

Great. Thank you.

And then your last question about moving outside of MS. I don't think there's any pre-work that we need to do. I think it's just logistics of getting it done within the context of all the other things that we have on our plate for this year. So that's probably a later-in-the-year event than an earlier year. I think we've got – the higher priority projects will be the stuff I talked about where we are trying to make IV BRIUMVI even more convenient. The subcu and the azer-cel stuff is probably on a higher priority setting for the earlier part of the year. But yeah, I don't see any barriers to going outside of MS.

Thanks Mike. I appreciate it.

You got it. Thank you.

Thank you. The next question is coming from Matt Kaplan of Ladenburg Thalmann. Please go ahead.

Hey, good morning, guys, and congrats on the progress. Just to stay on the enhanced – yeah, good morning. Just to stay on the enhanced Phase 3b switching trial, can you provide a little bit more information in terms of what we should be looking for from that data as it's released at, I guess, ACTRIMS and at later conferences this year?

Matt, it's like a day or two away. Really, you want me to give it all away? Yeah, I mean, look, so what are we trying to accomplish? I think it's a fair question. So, we want to make it as easy as possible for folks to be able to switch seamlessly from another CD20 on to BRIUMVI. It's no secrets. Doing an extra four-hour infusion is not the ideal situation for that patient population who already are B-cell depleted. So the goal is – step one is, can you safely take a patient who's on another drug, they are B-cell depleted, and put them on another CD20 without sort of this initial conditioning with a regimen that we have for the starting dose? So that's step one. So safety is the utmost importance, and that's what we wanted to do. Partly we wanted to get that done too, because we had heard in the field that people were just switching people straight through to one-hour BRIUMVI. So we wanted to make sure we have safety. The next part is, look, I think we would love to get it into the label. We are eliminating 150 milligrams of drug, so there will be an efficacy question. I don't think it's a material efficacy question, but it has to be answered. So I think as we move forward, one, what are we looking for? Make sure it's safe and well-tolerated to switch people directly to a one-hour BRIUMVI from another CD20. And if there's any signal that we'd somehow be losing some activity by eliminating the 150 milligrams. So I think we're still probably in the safety phase of this trial. So I think in ACTRIMS we'll be looking for more safety information. Probably by the time we get to ECTRIMS, we should be able to have some additional efficacy. Again its single arm, so the efficacy information will be, pretty straightforward, looking at MRIs and just making sure that there's nothing going on that would be surprising.

Okay. That's really helpful. Thank you. And then in terms of your plans for BRIUMVI outside of the MS opportunity, can you help us think about how you prioritize the different indications that you are potentially looking at?

Yeah. I mean, I think – look, we want to get started probably somewhere in the RA Lupus arena with it. I can't promise that that's what's going to happen, but we do think that there's an interesting opportunity. It also will dovetail nicely as we look to get azer-cel and some of those indications as well. There's a nice synergy of clinical resources, so that's an angle that we're looking at, but I can't promise as the year goes on. We may have additional thoughts and we may start someplace else. But we do believe that BRIUMVI is designed well for large market indications and right behind it, azer-cel is designed for the more smaller, sicker kind of patient populations, potentially within the same indications.

Okay. Great. And then lastly, in terms of the recent patents that you announced, can you provide us some more detail in terms of what they cover and providing the protection after it was at 2042?

Yeah. I mean, there's a lot of detail in those patents, but I think the sum in some sense is that in addition to a new composition of matter patent that covers the glycosylation profile of BRIUMVI plus some use patents within that, we feel good about the 2042 patent protection. So we feel that we've got a really nice runway here, but the forms are issued, they are out there. People can read them. But the overriding concept is that it's a composition of matter plus some use patents. 2042 is a nice new place for our exclusivity to run to.

Okay. Thanks a lot.

We have a question coming from Eric Joseph of JP Morgan. Please go ahead.

Hi, guys. This is Noah. I'm for Eric. Thanks for taking our question. Our question is with regard to subcu BRIUMVI? How important to drive uptake would it be to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence? Thanks.

So the current competitor that's moving from their IV to subcu did a bioequivalence study. We're hoping that we'll be able to follow a similar pathway. So, I don't think we're going to need to do a full efficacy study to bring the subcu forward. But that will be definitely subject to more conversations with the FDA. But as of now, the competitor subcu that's moving from IV conducted a bioequivalence study and we think that's an appropriate pathway.

Thank you.

You got it.

Thank you. The next question is coming from Prakhar Agrawal with Cantor Fitzgerald. Please go ahead.

Hi. Good morning and congrats on the progress. And thanks for taking my question. So number one, Adam, you said 1Q is tracking at the top end of the guidance range. So, maybe if you can give some more details on the January and February trends. Where is the demand growth coming from in terms of patient segments, as well as physician segments, academic versus community?

Yeah. Hi, Prakhar. Thanks for the question. I'm not going to get into too many details beyond what I said in the prepared remarks. We got off to a really strong start to the quarter. And as I said, we're feeling really good about our guidance to the higher end of that range, and then any other details we'll discuss on the next quarter call.

Got it. And do you have a sense of what's the split of academic courses, community patient segments for BRIUMVI, and how do you expect that to trend over time?

Sure. So in the beginning of the year, as I mentioned, it was probably 60-40 private practice to academics. In the most recent quarters, it's more 50-50 academic to private practice. And we are seeing, as I mentioned in the remarks, growth coming from academic centers in the latter half of the year and especially in the fourth quarter.

Got it. And lastly, what percentage of patients who are getting a prescription actually end up getting the infusion? Do you have any additional details on the trend there? And what's the time lag between getting a prescription to getting an infusion right now, and how does it track relative to Ocrevus?

Yeah. So the conversion rate, we have it's still pretty early, and we have not given a number on that. It's encouraging, but we haven't given a specific number. Perhaps in future calls, we'll look at it, but we still think it's very early to be giving that number. And then Prakhar, can you repeat the second part of that question?

Right. So what's the time lag between a prescription and getting the infusion, and how does that trend versus Ocrevus?

Yeah. So I think what I've said in the past, it's about a six-week timeframe from enrollment into the hub into the first infusion, approximately. And from what we understand and from what we – it's very similar to what you see with Ocrevus. There are a lot of things you can control in that process, and there's things that are outside your control. We continue to see a trend in the direction, we continue to shorten it over time, and so we'd like to see that trend, and we think it's very much in line with what's the competitor product.

Thank you. And Congrats on the quarter.

Thanks.

Thank you. Our final question today is coming from Mayank Mamtani of B. Riley Securities. Please go ahead.

Thank you so much. This is actually William Wood on for Mayank Mamtani. Congratulations on the past year, and thank you for taking our questions. In terms of the cash and the OpEx burn for 2024, how should we be thinking about the spend allocation between your trials and what's been factored so far into the subcu trial? And then additionally, on the subcu trial, do you have any view of frequency of administration or the kind of device that you'll be using for the formulation? And then one follow-up. Thank you.

Yeah, so on the subcu, we don't know yet in terms of the frequency of dosing. I think part of that is just going to be let's look at what the conversion is between the two from IV to subcu, and from there we'll be able to design the appropriate dosing interval. Our goal, obviously, we know what the goalposts are. We've got once a month from one of the subcu products, and the other is once every six months with a pretty clunky product, as far as we can tell and so somewhere in between we think we'd be very successful. So we're going to try to get there. We won't know if we can until we put the material into people and see how it does and see how they react to it.

Alright. And on the OpEx guidance, obviously we've guided $250 million in OpEx for ‘24. We haven't provided a detailed breakdown of how that shapes out, but everything that Mike and the team discussed today is obviously included in that $250 million guidance number.

Appreciate that. And then just one last question. You obviously reported multiple new patents providing protection in the 2042, including COM as you just noted, as well as the recent launch in the EU. How should we be thinking about this in terms of potential external parties viewing these events and maybe spurring additional interest in TG?

Yeah, our goal is to build our business. We're not too worried about external parties. I think if you are referring to external parties being investors, I would hope they'd be updating their models to understand the significance of patent protection through 2042 and what that means to the overall NPV of the SAP. Other outside parties I'm not too worried about.

I appreciate that, and thank you for taking our questions.

Great. Thank you.

Thank you. At this time, I'd like to turn the floor back over to Mr. Weiss s for closing comments.

Great, and thank you. And again, thanks to everyone for joining us this morning. As reported, we had a great launch year, and year two while early is taking shape, and we're excited about our target guidance for this year of $220 million to $260 million in U.S. net sales revenue. Our pipeline and lifecycle management activities are in full swing and believe these activities could translate into significant future value for TG, and our recent patent issuance will ensure a long runway to explore the full potential of BRIUMVI. Finally, I want to thank again the whole TG team for their dedication to serving the MS community and for their incredible efforts on behalf of TG. Hope everyone has a very nice day.

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.