Greetings, and welcome to the TG Therapeutics' Third Quarter Conference Call and Webcast. At this time, all participants are in a listen-only mode. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Jenna Bosco. 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 third quarter 2024 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 a summary of our financial results before turning the call over to the operator to begin the Q&A. 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 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 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 later 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 www.tgtherapeutics.com, where it will be available for the next 30 days. With that, I'd like to turn the call over to Mike Weiss, our CEO.

Thank you, Jenna. And good morning, everyone, and thank you for joining us for our quarterly earnings call. We're excited to share with you the results of another quarter of growth and execution of our BRIUMVI launch. The positive feedback and uptake for BRIUMVI in the marketplace continues to outpace our expectations. And the strong data presented during the annual ECTRIMS meeting from the ULTIMATE I & II trials and the ENHANCE Phase 3b trial, both evaluating BRIUMVI in individuals with the relapsing forms of MS continues to strengthen our belief in the long-term value of BRIUMVI. We remain highly focused on the commercial success of BRIUMVI. And I'm excited to share with you our current progress, as well as our future plans to continue to grow BRIUMVI and shareholder value. Let's kick things off with a brief review of the quarterly sales. I'm happy to report that BRIUMVI third quarter US net sales were $83.3 million. Adam Waldman, our Chief Commercialization Officer, will join shortly to provide a full commercial update and year-end guidance. But I wanted to say that I'm extremely pleased with the continued commercial launch effort. The team continues to execute on our phase launch plan, setting us on what we believe is a path for continued growth and strong momentum heading into the end of the year and into 2025 and further toward our long-term goal of becoming the number one prescribed anti-CD20 in terms of dynamic market-share. To that end, let's discuss some of the BRIUMVI data presented at the recent ECTRIMS annual meeting. As I alluded to earlier, we presented two important datasets during the meeting. The first was a long-term follow-up data from our open-label extension study from the ULTIMATE I & II Phase 3 trials, which as a reminder, were the…

Yes. Thank you, Mike. I'm excited to share the continued commercial success we've experienced with BRIUMVI and the steps we are taking to drive future long-term growth. Since its launch, BRIUMVI has consistently exceeded our expectations with Q3 marking another strong quarter of sequential revenue growth. As Mike mentioned, we achieved second quarter net sales of $83.3 million, reflecting approximately 15% quarter-over-quarter growth and over 230% growth from the same quarter last year, solidifying BRIUMVI as the fastest-growing DMT in the US MS market. And while we did observe some expected summer dynamics in the third quarter, where new patient visits tend to slow particularly during July and August, enrollments into our hub rebounded in September. And that momentum continued into October where we saw a record enrollment month. We continue to see steady growth in new prescribers and treatment centers, now reaching nearly 1,100 prescribers across approximately 600 centers, including 95% of the top 100 MS centers since launch. Encouragingly, two-thirds of the new prescribers in Q3 came from the hospital setting, which is now our fastest-growing segment and accounts for approximately 55% of our overall business. We continue to believe in BRIUMVI's best-in-class profile, including its high level of efficacy, well-established safety profile, and a one-hour infusion every six months, attributes which we believe strongly resonate with healthcare providers looking for a convenient yet highly effective treatment option. We were particularly excited to see the overwhelming positive response to BRIUMVI at the ECTRIMS conference in September. As Mike mentioned, BRIUMVI was featured prominently and the clinical data we presented garnered strong interest from healthcare providers and thought leaders in the MS community. Several key takeaways emerge from the conference from a commercial perspective. First, we believe the ENHANCE trial, which show the potential for BRIUMVI to have a…

Thank you, Adam. And thanks again to everyone for joining us. Earlier this morning, we reported our detailed third quarter 2024 financial results, which can be viewed on the Investors & Media section of our website. This morning, I'll start by highlighting our Q3 revenue. As Adam detailed earlier, we are pleased to report third quarter BRIUMVI net product revenue of $83.3 million for the three month period, bringing our year-to-date nine month BRIUMVI net product revenue to $206.4 million. Turning now to our income statement for the period. We are pleased to report that we generated net income in both the three and nine months -- nine month periods ending September 2024. For the three months ended September 30th, 2024, our GAAP net income was approximately $3.9 million or $0.02 per diluted share. When excluding non-cash items, net income for the three month period was approximately $15.7 million. Our OpEx during the quarter, excluding non-cash items, came in at the low end of our guided range at approximately $50 million. Our OpEx for the first nine months of 2024 is approximately $155 million, and for the full year, we expect our OpEx to come in well below the guidance of approximately $250 million. And finally, I'll close by touching briefly on our cash position. We ended the third quarter with approximately $341 million in cash, cash equivalents and investment securities. Which we believe provides us with a strong financial position to support the BRIUMVI commercialization, our research and development efforts and our continued business operations for the foreseeable future. On a related note, I'd like to briefly touch on our share repurchase program, which we commenced during the third quarter. We began slowly buying shares back during the third quarter and will continue with a measured approach for the foreseeable future. Although the share amounts repurchased during the third quarter were minimal, we do expect this program to continue throughout the remainder of the year and into 2025. With that, I will now turn the call back over to the conference operator to begin the Q&A.

Thank you. I'll now be conducting a question-and-answer session. [Operator Instructions] Our first question today is coming from Ed White from H.C. Wainwright. Your line is now live.

Good morning. Thanks for taking my questions. First, I wanted to ask a big picture question. You mentioned in the press release that you expect to see continued growth in 2025. I just want to get your thoughts on the size of the anti-CD20 market in MS in 2025 and your thoughts on market share, not only for BRIUMVI, but also IV versus subcu?

Thanks, Ed, for the question. Adam, you want to take a crack at that one?

Sure, good morning, Ed. Sure, so big picture, I mean, we see CD20 continuing to grow. It's in the low 50% of dynamic share today. We see no reason that that can continue to grow to mid-50s to even 60%. I think the momentum continues behind the class. As far as our market share growth, we're about 15% of the CD20 market today. And we think we have a lot of room to grow.

Okay. Thanks. And just a question on the announced FUJIFILM secondary US-based manufacturing. Your gross margins have been pretty consistent this year quarter-over-quarter. Will this agreement have any impact on gross margin going forward.

Sean, you want to tackle that?

Hey, Ed. Thanks for the question. In the near term, absolutely not. And we'll have some upfront expenditures associated with that. But that will of course run through R&D. In the long-term, we think gross margins would remain consistent. So short answer to your question is no, no real impact on gross margin.

Yes Hey, Ed, I forgot to answer one part of your question, which was the IV to subcu. We believe it's around 70% IV to subcu in terms -- and we do still believe it is, as Mike said in his remarks, the clear patient preference today. And we see that continuing.

Great. Thanks, Adam. And thanks, everyone. Congratulations on the quarter.

Thanks, Ed.

Thank you. Next question is coming from Michael DiFiore from Evercore ISI. Your line is now live.

Hey, guys. Thanks so much for taking my question and congrats on the quarter. Two for me. Were there any inventory channel dynamics during 3Q? And separately, what was the TRx script count in 3Q? And how many new patient scripts have been received in the hub? I noticed that wasn't included in your print this morning. Thank you.

Sure. Thanks for the question. Adam, you want to tackle this, the inventory in TRx?

Yes. First question, Michael, there are no changes in inventory in the quarter. All distributors are at normal inventory levels. And as far as the enrollments, we're going to move away from providing that number. I think, as we continue to grow our hospital business, our capture rate continues to go down in terms of -- because hospitals are just less likely to use our hub. So we just don't think that this is going to be an accurate measure going forward. I think directionally, it can help, certainly. But I think in sort of using it as a way to sort of garner whether we're growing or not growing is just with the capture rate fluctuating and more and more hospitals coming into play that are certainly just not using it, we've decided to focus more on the revenue guidance as we've done over the past several quarters, and we'll continue to do going forward. But we just don't think hub enrollments are -- it was good in the beginning. I think, certainly in the beginning, where we had a much higher percentage of our business coming from private practices, that use the hub much more consistently, it was a good measure. As we continue to go out here as more -- I said in our remarks, about 55% of our business now is coming from hospitals, it's the fastest growing of our segment. And they're just less likely to use our hub. And that creates some difficulty in interpreting the information out of the hub enrollment data.

Got it. Very helpful. Thank you.

Thank you. Next question is coming from Eric Joseph from JP Morgan. Your line is now live.

Hi, good morning. Just picking up on the plan to adapt for a faster infusion time just coming out of the ENHANCE update at ECTRIMS. Can I get you to elaborate a little bit more on sort of what you -- what might be needed to support a label indication for either a shorter infusion or skipping the loading dose or switch patients? You mentioned possibly needing randomized data. Would the focus there be exclusively on safety? And would you need to assess more than one infusion per patient as part of that -- as part of a trial like that?

Yes. Thanks for the question, Eric. So the answer to the last part of your question, will we need more than one infusion is probably unclear today. But I don't think so. I don't think we'll need more than one infusion per patient to tell on the safety. And yes, it's primarily a safety study. For faster infusions, historically, when you've -- they've been done before with other companies and they do require randomized trials. And they usually are looking at safety and tolerability. So I think that's what we're -- our expectations are.

Okay, great. And maybe a follow-up if I could, with respect to the subcu initiative. Can you talk a little bit about sort of what you are tracking in addition to safety to kind of verify or sort of assess how long of a dosing interval you could ultimately move forward within a pivotal study?

Yes. So again, with subcu, we're looking at primarily the bioequivalent. So again, it's just the amount of material required to match the PK. And yes, that will determine the tolerability of the materials. To put too much in, you would at some point start to see a deterioration in tolerability at the injection site. But the primary focus is the bioavailability. That will tell you how much material you need to load into the injection. And that will ultimately, as you mentioned, impact how tolerable it is. So it's -- all of those pieces will come together at some point soon. We're hoping, like I said, to be able to share that data early next year. But those are basically three pieces that have to come together.

Is there a PD component? Are you looking at sort of the B-cell decline?

Yes. I could share with you that B-cell decline is not an issue at any real dose level.

Okay. Thanks for taking the questions.

Yes. Thank you.

Thank you. Next question is coming from Tara Bancroft from TD Cowen. Your line is now live.

Hi, good morning. Thanks for taking the questions. So thinking about your guidance, it assumes just over -- or I guess, just under 20% sequential growth. And that's incrementally higher than the 15% from Q3. But I was wondering, looking ahead now, should we assume steady growth like this from here on out or a similar cadence of growth like in 2025 like you saw this year and last year with a heavy Q2 and seasonal impacts, just a bit on how you would vision near term dynamics here would be really helpful? Thanks.

Sure. Thanks. Adam, you want to talk on that one?

Sure, yeah. Thanks for the question, Tara. I mean, we try to provide the best information we have when we have it. I think the guidance is strong and shows sequential revenue growth. We're continuing to do some things here and make some investments. And as I mentioned in my remarks around patient awareness and other things that we are hoping will continue to fuel the trajectory of the growth of this product. As I mentioned, we think we're poised to make this a blockbuster brand. And that trajectory. I think there are seasonal -- if you look at the MS market in general, there are some quarterly season dynamics that are in play. As I mentioned in Q3, there were some in just the summer months. That can affect the exact line. But I think we are poised to grow more. We're doing things in the market that are getting traction. And we're very excited about what the future is for BRIUMVI.

Okay, great. Thanks. And just a quick follow-up on the previous question about subcu. I understand you mentioned a lot of expectations there, which was helpful. But can you tell us what volume and perhaps dosing interval that you're ideally targeting with the subcu formulation?

Sure. Yes. So I mean, ideally, it would be as less frequently as possible. I think sort of a minimum bar would be certainly every other month, I think, is the minimum bar that we're targeting. And anything less frequent than that, we think would be fantastic. And we'll be obviously working towards that, of course. But no promises. But yeah, the minimum profile, I think would be every other month is the target for that.

Great. Thanks so much.

Thank you. Our next question today is coming from Matt Kaplan from Ladenburg Thalmann. Your line is now live.

Hey, good morning, guys, and congrats on the quarterly results. I guess for Adam, can you expand on the rates of persistence you're seeing and how it compares to other therapies in the space?

Yes. Hey, Matt, thanks for the question. The only compliance numbers that we have or that we've seen that are published are with the other IV CD20 competitor. And we're doing -- so that's been sort of our benchmark. And what we were expecting and we continue, it looks like, again, we're continuing to collect data, but it looks like we're doing at least as good if not better on the week 24 compliance than what's out there and published.

Okay, great. And just a follow-up on the ENHANCE data and the questions with respect to when you could see that incorporated into clinical practice. When do you think you could complete the studies necessary to have that available and update the label?

Thanks, Matt. So the goal would be to get those studies started sometime next year. Those studies, again, with enrollment, it's a randomized trial of reasonable size, let's say, give or take 200 to 300 subjects. It's going to take at least a year. So you've got a year of enrollment, follow-up should be short. So we should be able to follow the patients and get that data put together pretty quickly and get a filing in. And so I think we're -- even in best case scenario, probably a two- to three-year process to get into the label.

Perfect. Thanks, Mike.

You got it.

Thank you. Next question today is coming from Mayank Mamtani from B. Riley Securities. Your line is now live.

Good morning, team. Congrats on a strong quarter. And thanks for taking the question. So on the revenue split, if you are able to share between maintenance and maybe new to BRIUMVI patients, if you are able to confirm at what juncture the maintenance patients overwhelmingly take share with the new to BRIUMVI patients. And did you comment by any chance on the share for new to CD20 versus newly diagnosed IMS patients? And would love to hear any color you are seeing in the marketplace within the intra CD20 class switch, what percent patients are up for grabs. We'd love to hear any perspective on that.

Sure. Thanks, Mayank. Adam, you want to take a crack?

Yes. As far as the first question, the revenue split is still mostly new versus repeat. But we do expect, in the next several quarters, that that will turn upside down, repeat prescriptions will start to be the lion's share of the infusions going in the next couple of quarters as we continue to stack -- the stacking effect and we continue to get patients coming back for week 48 and so on and so forth. But today, it's still news that are majority. But in the next several quarters, we do expect repeat to increase and become the dominant amount from a revenue split perspective. I think the second question was on share of newly-diagnosed. Is that right, Mayank?

Yes, yes, that's accurate.

Yes. We haven't provided shares in newly diagnosed or new to CD20. We haven't provided those shares. And then your third question was about switching. And we do see, we continue to see a sizable portion of our, of our BRIUMVI business coming from switches from both Ocrevus and Kesimpta. And that has remained pretty steady and consistent since launch.

I ask that because one of our recent surveys indicated up to 20% of those patients might be up for grab so hence the question. And then lastly on the biologics manufacturing expansion implication, are you able to comment on any long-term supply goals that you may have in mind between the Korea and US facilities, any way to quantify that would be very helpful, Mike. Thanks again for taking the question.

Yes. So I don't think we have a good answer here on that at this moment, Mayank. But obviously, we're securing what we think is what was required for a long-term supply between both of Samsung and Diosynth.

Understood. Thank you.

Thank you. Next question is coming from Corinne Johnson from Goldman Sachs. Your line is now live.

Good morning, guys. Maybe a couple from us. You talked about the bulk of growth in your patient coming from the hospital setting. I guess, remind us what portion of MS patients are taking care of there and why do you think that's been such a good source of new patient growth for you? And then my second question is, as you think about 2025, could we see steady or even maybe accelerating new patient growth on an absolute basis into year three as you get kind of like well into the launch here?

Sure. I'll start with the second question. Yeah, I mean, certainly, we do believe that we can have accelerating new patient starts as we get into 2025. We've always felt that just generally speaking the more patients that go on BRIUMVI, more patients will go on BRIUMVI. So there's definitely sort of an inflection point that comes with that when we have enough people on it and have the critical mass. So we think that's part of it. As Adam mentioned in his prepared remarks, we are taking steps to push as hard as we can to get to that inflection point, whenever and how many patients that may be. We've expanded the size of our commercial team. We're expanding our, our marketing efforts coming into 2025. So yes, I mean, is it possible -- obviously can't promise it. I mean, I don't think the 15% to 20% quarter-over-quarter steady growth that we've had thus far is problematic. I think it's pretty darn good and will continue to bring us to a blockbuster within a short amount of time. But yes, I think it is also possible that the growth rate could accelerate as we get into 2025. Adam, you want to tackle the one about the hospital setting and the percentage of business that comes from hospitals?

Yes. So Corinne, it's probably 60% to 65% of patients are being seen in the hospital setting. That's why we're -- we think having continued expansion into that hospital segment is encouraging. And it is now the fastest growing segment that, as I mentioned in my prepared remarks, and it is where the majority of the patients in the US today are being treated.

Helpful. Thank you, guys.

Thank you.

Thank you. Next question today is coming from Prakhar Agrawal from Cantor Fitzgerald. Your line is now live.

Hi, good morning and thank you for taking my questions and congrats on the quarter. Maybe firstly, now that subcu Ocrevus has launched, what are you seeing on the ground in terms of where it's gaining more share from even qualitatively? And second question, you'll start generating obviously a lot of cash over the next few years. Maybe on the broader capital allocation priorities, is there any plans to expand the share buyback program or any other mechanisms you can explore on the capital allocation front?

Sure. Thanks, Prakhar. Adam, you want to talk about what we've seen in competitive dynamics in the market recently?

Sure. Yes. So, Prakhar, thanks for the question. We've seen no impact from Ocrevus novo to date. We had -- as I mentioned in the prepared remarks, we had the best month of enrollments ever in October. So no impact as far as we can tell right now.

And Prakhar, in terms of allocation of cash, yeah, I mean, well Sean did mention, we've been -- we started off conservatively with the share buyback program. It is something that we're committed to continuing on an ongoing basis. So yeah, we do believe we'll be allocating over time more cash to share buybacks. But in addition, as Adam again in his prepared remarks, I alluded to in the prior answer, we're committed to expanding the use of BRIUMVI. So obviously, we're going to be allocating cash toward continuing to build and grow our team, continuing to build and grow our marketing efforts, which as everyone has followed us closely knows we start out with a pretty modest marketing budget when we launched in 2023. And I think by the time we get to 2025, we'll have a pretty healthy marketing budget. So again, I think we're leaning into the opportunity we see BRIUMVI as a blockbuster brand and we're going to make sure we try to get there as quickly as we can. So we will be using cash and investing in those activities. And as part of that, again, we'll be investing in these clinical programs that you heard about earlier, right. So we're going to be running more likely than not several randomized trials commencing in 2025 for faster infusions, skipping the doses, so streamline the front end, and of course, subcu, which is obviously the highest of the priorities of that grouping. So we're going to make investments in those as well. So that's where some of the excess cash goes. Obviously, as we mentioned, is ourselves moving forward, we're excited about the potential there. And then lastly, our eyes are peeled and our business development program is active. And if we see something that we think really augments and complements what we're doing, we're going to make investments there as well. So I think we've got plenty of potential uses for the excess cash, although we're not dogmatic about how it gets spent except, I'd say on the front end with the investments in making sure BRIUMVI gets as quickly as possible to that blockbuster level.

Thank you. Next question is coming from Roger Song from Jefferies. Your line is now live.

Great. Congrats for the quarter and thank you for taking my question. Most of my questions related to BRIUMVI have been on third. And then maybe just a follow-up on the capital allocation for those additional pipeline. So one is in terms of the BRIUMVI expanding to MS indication, when you start the trial later this year and then would you be able to give us provide some proof concept data to support the plan? Number one. Number two is in terms of the allogeneic cell therapy. Do you expect to give us some data update next year? And then what will be the -- be the principle to share the data in terms of the number of patients and the maturity of the data? Thank you.

Yes. Thanks, Roger. So I'll start second, since it's the fresh question and I'll work backwards. So the azer-cell question. Yeah, I mean, look, we're hopeful to get that study started later this year. So we've got two months left to put our first patient in. If not it will be early next year. The cadence of data coming out of that trial, I think is yet to be determined. Let's hopefully get some patients on as quickly as we can. It's the logistics of these trials and the ability to put patients on rapidly is not the same as working with other biologics. So, but if we can get a decent number of patients on as quickly as we can, hopefully we can get some data out sometime next year. But I wouldn't anticipate any available data until the second half and more likely than not. Second half of the year. But again, it's hard to really tell how fast we can enroll, although, again, historically, these studies have enrolled slowly. So let's keep a hopeful eye on that because I do think it has a lot of promise in the areas. In which we intend to study, particularly progressive MS and some other areas that we have slated to look into. So TBD on that one, Roger, will keep you posted. And in terms of the outside BRIUMVI MS plans, I can say from the beginning of the year, we did note that that was probably the lowest of our, of our near term interests and priorities. I think we are working toward getting some patients on non-MS indications before the end of this year still and we can report on that if and when it happens. And I think part of the challenge in our plants outside of MS right now are really evaluating all the options. I mean there's been so much new CD20 and B-cell data that's come out across multiple disease areas that we've been really taking our time. And I know we've said this before, but with new information gives us more options to look at and to decide. And it's also the thought of whether it's an IV opportunity or potentially subcu opportunity as we move into some of these other indications. So I don't have any specifics to discuss today, but it is definitely on the radar screen. The team is working on putting non-MS patients into trials this year and the commercial team certainly is helping us to evaluate what the next best indications are going to be. And I'm assuming 2025 will talk more about that and we'll get that up and running.

Thank you. We've reached end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

Great. Thank you. And thanks again everyone for joining us on today's call. We look forward to continuing the positive momentum into the end of the year and into next year. And as discussed today, we'll continue to be focused on several key priorities. First, expanding our BRIUMVI launch effort, including building out our commercial footprint and increasing our spend in marketing. Next, advancing our BRIUMVI expansion initiatives through our subcutaneous development, our enhanced switch study and exploring new indications for BRIUMVI. And finally, commencing our Phase 1 azer-cell and progressive MS as well as looking at opportunities to expand our pipeline. With that, I'd like to close by thanking those with MS and their healthcare providers that put their trust in TG and BRIUMVI and our loyal shareholders for their support. And once again, the whole team at TG for making it all happen. Have a great day.

Thank you. That does conclude today's teleconference webcast. You may disconnect your lines at this time. And have a wonderful day. We thank you for your participation today.