Greetings, and welcome to the TG Therapeutics Conference Call and Webcast. [Operator Instructions] 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 first 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 development, 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 or clinical 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.

Great. Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. 2024 is off to an exciting start, and I'm incredibly proud of the accomplishments already achieved this year. Company-wide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the award of the VA contract for Briumvi as the preferred anti-CD20 for the VA system. We cannot be more excited to be able to support our veterans with multiple sclerosis by offering Briumvi at a deep discount. We see this as a great way to serve our veterans, introduce Briumvi to additional health care providers, many of whom split their time between the VA and their academic appointments and, of course, generate incremental revenue. As for the first quarter, the demand for Briumvi was extremely strong, and I'm pleased to report that the U.S. Briumvi revenue was in excess of $50 million, and total revenues for the quarter were over $63 million, which includes milestone payments received from our ex-U.S. partner. By any measure, it was a robust revenue quarter for TG. As mentioned previously, starting in late 2023 and continuing, we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team. I have to believe these investments contributed to the strong first quarter results. More broadly, our team continues to be focused on our long-term goal of becoming the #1 prescribed anti-CD20 from a dynamic market share perspective. And the feedback from physicians, patients, nurses and infusion centers continues to drive our confidence that, that is achievable. We believe that Briumvi has best-in-class profile that should help us get there. Briumvi is the only anti-CD20 monoclonal antibody that can be given as a 1-hour infusion every 6 months following…

Thank you, Mike, and good morning, everybody. I'm excited to provide insights into our continued commercial progress in the first quarter. This was another very strong quarter of performance, exceeding our revenue guidance in all of our key performance metrics. Our focus on delivering Briumvi to patients remains unwavering, and I'm pleased to share our progress with you today. In the first quarter of 2024, we continue to see strong uptake of Briumvi in the market. As reported in our press release, first quarter net sales in the U.S. for Briumvi were $50.5 million, representing 25% growth quarter-over-quarter. The first quarter number exceeded our original guidance of $41 million to $46 million provided in early January as well as our updated guidance we provided in late February. The trends we saw early in the quarter continued throughout the quarter, reflecting strong and growing demand for Briumvi. This growth is particularly impressive given the first quarter challenges associated with beginning of the year payer dynamics. In fact, we were the only CD20 in MS to see revenue growth quarter-over-quarter in the U.S. market during this time frame. Equally impressive is that we also saw enrollments grow by approximately 25%, with over 1,250 new patient scripts received by the TG hub in the quarter. I want to congratulate our team on doing an exceptional job preparing for the inherent insurance-related challenges seen in the first quarter and mitigating the potential impact. Since launch, we've implemented a comprehensive commercial strategy that encompasses targeted educational initiatives; engaging health care providers, both virtually and in person; and leveraging digital marketing channels to reach a broader patient audience. Our efforts have resulted in increasing uptake of Briumvi, with health care providers recognizing the value that Briumvi brings to patients. Concurrently, ensuring patient access to Briumvi remains…

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed first quarter 2024 financial results, which can be viewed on the Investors & Media section of our website. This morning, I'll start with a discussion of our revenue. We are pleased to report total revenue of approximately $63.5 million during the first quarter of 2024, which, as previously mentioned, includes $50.5 million of U.S. Briumvi net product revenue. Also included in our Q1 '24 revenue total is approximately $13 million of license milestones, royalty and other revenue, which consists primarily of the $12.5 million milestone we received from our ex-U.S. partner for the first commercial launch of Briumvi in the EU. Our OpEx during the first quarter of '24, despite some onetime charges, has remained well controlled and in line with previously discussed ranges. For the first quarter of '24, our operating expenses were approximately $58 million, which includes onetime charges to research and development expenses of approximately $8.8 million related to our agreement with Precision BioSciences for the in-licensed azer-cel program. During the first quarter of '24, we also saw a modest increase in R&D expenses, driven by manufacturing and development costs associated with our ublituximab subcutaneous development work. On the back of the reported revenues and well-controlled OpEx, during the first quarter of '24, we reported a modest net loss of approximately $10.7 million or $0.07 per share compared to a net loss of approximately $39.2 million or $0.28 per share during the comparable quarter in 2023. From a cash standpoint, we ended the first quarter with $209.8 million in cash, cash equivalents and investment securities, down less than $10 million from Q4 of '23. 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.

[Operator Instructions] Our first question comes from the line of Michael DiFiore with Evercore.

And congrats on all the great projects this quarter. A couple for me. Regarding sales in EU, I know it's very early, but when could we expect Neuraxpharm to begin offering details? And I have two follow-ups.

Yes. So in terms of Neuraxpharm providing public details, I think we're a long way off. They are a private company, private equity backed, so I don't anticipate they'll be providing any public guidance or information to my knowledge. Adam, anything different from your side?

No, no. Nothing to add there.

Okay, okay. Fair enough. And my other two questions are, how much of Briumvi's fiscal year '24 guidance raise was due to the recently announced VA contract? And any color that you could provide on pricing or increased rebating in this segment? I know you said it's heavily discounted.

Yes. Adam, go ahead.

Sure. Yes, the revenue raise was really -- the VA was not really factored in for a couple of reasons. One, this won't go into effect until June. Second, it will be a gradual sort of increase as new patients get on. Patients will only really have the opportunity in this year to have the first two infusions at best. So it will be a gradual increase, and it wasn't really a factor in the way that we looked at raising our guidance. The guidance was raised based on the demand trends that we're seeing. As far as pricing, I think that's out there and public. We offered about a 72% discount, roughly about $2,900 a vial.

Okay. Great. And my last question is this. In the most recent cut of the enhanced data presented at ACTRIMS, three patients in Cohort 2 had to have their infusion slowed down or interrupted. Any color on these patients? How long would these infusions slowed down to or interrupted for? And were there any unique clinical features of these patients that could explain this?

So no, I don't think there was anything particular about the patients, but the infusions were pretty modest. And I think all we've done reasonably close to the 1-hour anyway. So no, I think it was just basic stuff that is typical of infusions. But I don't think there's anything to be worried about there. It was well tolerated overall, and those patients did well.

Our next question comes from the line of Ed White with H.C. Wainwright.

Congratulations on the results. So the -- just to clarify what you just said on the VA contract, Adam. Was it a 72% discount?

Yes.

Okay. And I -- this has been brought up before, but I just wanted to address it again. Thinking about the potential opportunity in the so-called crap-gap with OCREVUS. Is this something that you think you'll be able to produce data on or somehow address this with your sales force?

Yes. So in terms of crap gap and being able to show, I mean, we're trying to capture as much data as we can through the ENHANCE study. I think the number is about 50 to 60-ish percent. Maybe 2/3 report crap-gap as they're coming into the ENHANCE trial. So we'll try to capture some of that information on the back end. Hopefully, we'll have at least some anecdotal information about patients reported, whether they're or not seeing the crap-gap. It's hard -- there's no scale to objectively measure crap-gap. There's no -- so it is a challenging thing to measure, but we'll do the best we can within the ENHANCE study. And whatever studies that we conduct, we will certainly try to parse out the effect and whether we've changed that for patients.

Okay. And just -- when thinking about other potential indications, how do you prioritize outside of MS? I'm sure you have plenty of factors in there, but where does time to potential approval come in or size of the potential market? How are you sort of ranking that?

Yes. I mean, I think, look, we're probably focused on things like RA and lupus for Briumvi outside of MS sort of larger indications. And as we've said previously, in some more niche indications, we would be looking at azer-cel.

Our next question comes from the line of Roger Song with Jefferies.

Congrats to the 1Q results. And then so just a couple of questions from us. One is understanding your hub is capturing most of the new patients and given you have quite a few quarters since launch, so how would you characterize the repeat infusion rate you have been seeing?

Yes. Adam, do you want to go ahead on that one?

Yes. So yes, just to reconfirm here, the patient hub numbers that we're giving you are new patients only. So just to -- I think that was your question there. And then as far as persistence, we would say we're still early in the -- with our data, and we continue -- but however, the data that we see, we continue to see that the 24-week persistence is in line or maybe slightly better than our expectations of about 85%, week 24. So we feel pretty good about it. Although the data is early, we'll continue to look at it. But right now, it's in line or maybe slightly ahead of what we expected.

Excellent. 85% is good. And then so you are having now 800 health provider and around 450 centers. So understanding where you start to -- when you plan to launch, you are targeting top 50 accounts covering 70% to 80% with MS patients. Just curious, is that still the goal for the provider or the center outreach? And then if that's still the case, then when do you expect you will achieve that $550 million from $450 million?

Yes, yes. So I think if I understand the question, it's what's our goal in terms of new accounts and new prescribers. I'll just say that I think we've done really good. We've got broad adoption right now, but we certainly see opportunity for more adoption with even more prescribers and, of course, deepening the use with our current prescribers. The good news in the quarter as we saw increases in both repeat prescribers and adding new prescribers at a pretty good clip and new accounts at a pretty good clip. So we feel good about it. We're continuing to make progress every day and certainly have opportunity, but feel good about where we're at right now.

Okay. One last question related to the financials. So I think earlier this year, you're guiding the OpEx as $250 million for the year. Just want to confirm, is that still the guidance for now? And then also curious about the [ expenses ] for the coming years given you continue to launch and expanding your pipeline.

Yes. I'll take a first crack. And Sean, jump in. But yes, I mean, I think we're well on track to -- we said approximately $250 million in OpEx. It gives us a little wiggle room there. But if you look at even the first quarter, we had $58 million and change, and we had $8 million and change, which was the onetime to Precision. So the base OpEx is still only around $50 million for the quarter. So you multiply that times 4, you're still well under the $250. That gives us room to grow, and we are growing. Like I said in my prepared remarks, we're strategically adding to our team, and we're continuing to spend money on patient awareness programs. But I think, from where we sit today, we're in pretty good shape. Sean, any more details there?

No. I think you've covered it pretty well, Mike.

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann.

Congrats on the quarter. So maybe for Adam. In terms of new patient starts, can you give us a little bit more detail in terms of where they're coming from in terms of naive, switch and the background that you're getting these new patients from?

Yes. Thanks, Matt. So I would say we have not given out specific percentages of the patient and how it exactly breaks out. What we said is the biggest group is patients switching from non-CD20s, but we also have good representation from treatment-naive patients as well as patients that are switching from CD20s, like OCREVUS or KESIMPTA. So we're getting -- encouragingly, we think we're getting a nice diverse group of patients and, importantly, staying consistent quarter-to-quarter. There's no -- there wasn't any sort of big boluses of a certain patient group that sort of diffused over time. So we're seeing consistently representation from all three of those groups.

Okay. That's helpful. And then, I guess, in terms of the subcutaneous opportunity for the Briumvi formulation. I guess, recently on the Roche call, they said they see the subcutaneous opportunity as more than $2 billion. I guess, question is with your potential differentiated profile, what's your assessment of the subcu opportunity?

Yes. I'll speak broadly, and I'll let Adam chime in. I mean, look, the folks at Novartis have done a really nice job of carving out a subcu market. They've created it. And I think, as Roche probably mentioned, Novartis is probably over $2 billion and growing today. So there's a nice market there. And yes, I mean, our goal is to come into that market with a very competitive profile product. As we've said previously, we understand the parameters. We've got, on the one hand, a relatively elegant auto-injector once a month, and we've got a relatively bulky product every 6 months. Somewhere in the middle, we think it is an optimal product design, and we're going to try to get there. So I think from just where we sit today, we're seeing opportunity, and we're going to take our best crack at it. Adam?

Nothing else to really add there, Mike.

All right. Sorry about that.

Our next question comes from the line of Mayank Mamtani with B. Riley Securities.

Congrats on a strong quarter. Sorry, Adam, if I missed this. Did you say the revenue split up between new patient starts and maintenance patients? And I was also curious to hear from you how you think that stacking up effect in second half, how we should expect that revenue split to be. And if you can also comment on some other metrics you've provided before, free drug percentage, gross to net. Anything on that would be helpful as we think about the full year modeling. And then I have a couple of follow-ups.

Yes. We didn't share -- you didn't miss it. We didn't share any specifics on new versus continuing patients from a revenue perspective. We do continue to feel that this is a market where duration is a big driver of revenue, and there will be a pancaking effect that will -- as time goes on, patients will -- this is a very sticky -- the duration is really good. Patients are on drug an average of 5 years. So you will see that pancaking effect over time. So that's the best that I have for that question. I think your other question was free drug. As I said before, we did expect free drug rates to come down. We are seeing free drug rates come down. I think in the first quarter, we're about 12% is our -- right now, I think it was about 12%. From earlier in 2023, we're about 20%. So 12% in the quarter. And then from a gross to net standpoint, I think what we said previously is our gross to net is approximately 75%, will go up and down from quarter-to-quarter. But 75% is probably a good number to use for the remainder of 2024.

That's helpful. And then in your updated guidance for full year, I was just curious to learn how are you thinking about that year-end exit market share. Again, I don't know if you think of the market as total NRx percentage, which, Mike, I think you provided. You're tracking at that 10%. But obviously curious to hear how you think about that market share in terms of either total RMS patients or within the anti-CD20 drug class patient. Could you just give us some color on how -- what that $280 million midpoint assumes in terms of market share?

Yes. Mayank, I'm probably not going to get into any specifics. I mean, our goal here is to increase the depth of the use and the breadth of the use and continue to add new prescribers. We see continued opportunity for growth. We feel very confident in the trajectory. We feel very confident in the demand trends that we're seeing. And we're going to continue to focus on growing the usage of Briumvi across the market, and we're doing a great job of it. And based on our guidance here, we feel -- obviously, we feel very confident in continued growth going forward.

Go ahead.

Yes. I'm just going to chime in on the first question you asked about the revenue split, new versus old. Just -- I know we're not providing actual numbers, but I think it's worth just to mention that in the early years, we're going to be driven by the new starts. In the later years, we will be driven by the ongoing or stacking patients. So if you look at probably our competitive IV CD20s has been on the market for a long time, the vast majority of their sales are going to be based on continuing patients, not on new patients in any particular quarter, where as I'd say, we're probably the opposite still, right? We're still reliant on our new starts. But over time, the continuing patients sort of take the commanding role in how the revenue stack up.

Yes. And that bodes well for that size of that pancake downstream. Yes. I guess, last question on the subcu target product profile, Mike. Just would be helpful to understand how you and even some of the KOL feedback, now that we know what the subcu profile for OCREVUS would look like at launch, now that all the data is out there, was just curious, Mike, as you design the human bioequivalent study, what differentiating attributes are in mind as we think about that product profile?

Yes. So look, the OCREVUS subcu is not a true patient administered at home product today. So that is yet to be created -- or not created, but to be available or even studied as far as my knowledge. So that's still yet to come. I mean, our goal is to have something that is a patient-administered, patient-friendly product, again, more along the lines of what was done with ofatumumab. So I don't know how much markets they are in. We think there's a lot of room to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient and easy to use.

Our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald.

And congrats on the quarter. So just following up on the subcu Briumvi question. I'm trying to understand, what's your base case assumption on where the dosing frequency could land for subcu Briumvi? I guess, the reason I'm asking is if it ends up being once a month, would you still go ahead with the subcu development? And I have one more.

Yes. I mean, I think the bottom line is we probably would, but I don't think that's going to be necessary. So I don't know that, that's a scenario that is likely. But yes, I mean, it's early to tell. And again, I think if we feel like we've got something that has a good opportunity to make a dent in the market, we'll go forward. And certainly, once a month could be -- could have some impact in the market. Obviously, it probably has less impact than something that has a less duration, and we'll do the math on that in that concentration and less frequency. But I'm not so concerned that, that's an issue here.

And when do you expect patients to be dosed for subcu Briumvi?

We would hope to have first patients dosed within the first half of this year. So hopefully, in the next few months here.

Got it. And lastly from my side, we're seeing a lot of data on CD19 antibodies and other autoimmune indications. What's your view on CD19 versus CD20? And obviously, there is a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to, let's say, a CD20. So just wanted to get your perspective there. And do you have a CD19 in early-stage pipeline?

So yes, I mean, we do have a CD19. It's our azer-cel CAR T therapy. It is a CD19. So we think CD19 is a great target. We think it's hard to know if the broader coverage is a positive in all settings. There are some diseases that are characterized by plasma cells that may be impacted by CD19 or maybe expressed in CD19 or that may be helpful. NMO is one that folks talk about quite frequently as more potentially CD19 driven. So we think there are areas where CD19 may be helpful. But overall, we think the overall opportunity in CD20 and CD19 is going to be hard to distinguish in most diseases. And the CD19, when they hit -- hits pre-B-cell in addition to B cells, CD21 hits matured B cells. So in terms of recovery, you may see a difference there. So I think there's a lot of things to balance when you think about CD19 versus CD20. But from an activity standpoint, in most diseases, I don't know if you're going to see a material difference.

Yes. I guess, my one clarification. I was asking about the CD19 antibody, not the CAR T. Do you have a CD19 antibody in early stage, even preclinical?

We don't, we don't. I don't find that to be a product of interest to us at this time.

Our next question comes from the line of Eric Joseph with JPMorgan.

This is Noah on for Eric. We were just wondering if there were other exclusive procurement opportunities similar to the contract that you just secured with the VA?

Adam?

Not sure I understand the question. Could you clarify?

Yes. We're just wondering if there are other opportunities for [indiscernible] exclusive access contracts with other providers going forward?

Okay. Got you, got you. Okay. Understood. There -- I don't have any updates at this time on that question.

And our next question comes from the line of Corinne Jenkins with Goldman Sachs.

So maybe a couple of questions from us. One, you've stated that you guys are probably close to reaching profitability in the next quarter or 2 given the revenue guidance versus the OpEx guidance. How are you thinking through profitability versus kind of like it's ramping or extending your R&D or SG&A spend to support [indiscernible] and future development? And then from a technical perspective on the subcutaneous formulation areas, what else is left to do before you're able to enter the clinic?

Sure. So thinking about profitability, the -- I don't think those questions you asked are mutually exclusive or points, right? So we have -- we will continue to invest in the Briumvi launch. We've noted that we have an increased budget in OpEx to approximately $250 million for the year. So I think there's some room there to even grow. From a product standpoint, similarly, we are interested and continue to build among the Briumvi opportunity, the azer-cel opportunity. And we've said that we'll continue to look for additional external opportunities. So I don't know that we're fixated on the exact profitability numbers. I know that it may -- as EPS becomes something of interest. But I don't think the future is exclusive. And I do think we plan to continue to grow our Briumvi efforts and our team and continue with our R&D platform. But as an overall company, our -- I think, our cost structure versus most other companies, not all, but most, is pretty modest, and we've kept a pretty lean ship. So I think the consequence of that is we'll be at profitability probably sooner than most companies would, given the circumstances. In terms of the subcu technical aspects before entering the clinic, I think we're pretty much over most of the technical hurdles. I think we'll be able to get into the clinic, I believe, in the next 2 months or so. And I think there's a continuing effort to make continued improvements in what we're working on, which will all just be filtering into the clinical program. But I don't think there's any technical hurdles right now. Just getting -- get and going.

We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to Mike Weiss for any closing comments.

Great. Thank you, everybody. Well, okay, so I just want to thank everyone for joining us today. Hopefully, everyone has been able to see the excitement and enthusiasm that we have here at TG and what's going on with the company. We were -- the first quarter was quite good, in our opinion. We think everything went extremely well. And we look forward to continuing to push forward and achieve even more as we move forward into the remainder of the year. Again, we thank everyone for their support. Most importantly, we want to thank the clinicians and patients who definitely put their trust into TG. The whole team does appreciate it. With that, I'd like to thank everyone for joining us, and have a great day.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.