TG Therapeutics, Inc.

Greetings and welcome to TG Therapeutics' first quarter conference call and webcast. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires 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, Chief Communications Officer. Thank you. 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 2025 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 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 milestones, revenue guidance, development plans, and expectations for our marketed product. 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 at 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, everybody, and thanks for joining us on today's call. It's a pleasure to be here with you and to provide an update on TG's continued progress, both in the successful launch of Re-Envy and in building a company committed to improving the lives of those living with multiple sclerosis. I'm excited to share that we kicked off 2025 with another strong quarter performance, underscoring the sustained momentum behind Realme. As you may have seen in the press release this morning, Realme US net sales reached nearly $120 million in the first quarter, once again, exceeding our expectations. This growth reflects both the increasing adoption by healthcare providers and a rising tide of patient interest and confidence in BRIOMV. Over the past month, I spent a significant amount of time in the field, meeting with prescribers, and it's energizing to see firsthand how BRIOMV is becoming the go-to anti-CD20 therapy for many of them. But what's even more gratifying is hearing directly from people living with MS. At a recent MS walk, I spoke with two individuals who shared their experiences switching to Brianvi from another approved IV anti-CD20 therapy. They both described how they previously felt unwell for days or more after each infusion, but not with Brianvi. Their stories echo findings from a recent paper in Frontiers in Immunology, which highlighted seven case reports of people with MS who switched to BrionV from a prior anti-CD20 due to issues like tolerability, disease activity, wearing off effects, or incomplete B-cell depletion. In each case, the unwanted effect either resolved or did not recur with BrionV. These real-world experiences support the idea that not all CD20s are the same and that switching within the class may make a difference. This point is reinforced by another recent publication in CNS Drugs, which explores how structural and mechanistic differences among CD20 therapies may drive variations in efficacy and tolerability. Word of mouth within the MS community is powerful, and we believe these success stories are helping to drive continued growth and enthusiasm. As I often say, the more people who start BrionV, the more people will start BrionV. And even in a highly competitive market, our team and Briomvy's unique profile are rising to the challenge. I couldn't be more proud of how our team has executed our multi-phase launch strategy and the strong start we've made in 2025 as we pursue our long-term goal of making Briomvy the number one prescribed anti-CD20 as measured by dynamic market share. In a moment, Adam Waldman, our Chief Commercialization Officer, will walk you through the commercial performance in more detail, as well as our investment priorities and updated guidance for Q2 and full year 2025. But first, I'd like to highlight our pipeline and efforts to enhance the BrionV experience. A core focus of our innovation strategy is simplifying the patient experience. Our enhanced clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results. We previously presented data from this study demonstrating the safety and tolerability of a 30-minute maintenance infusion, as well as initiating BrionV treatment with a single full-dose 450 milligram infusion for patients switching from another CD20 who had low B-cell counts. And most recently, at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BrionV with a single 600 milligram dose on day one, effectively eliminating the need for a day 15 dose. Feedback on this streamlined approach has been very positive. We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BrionV a true twice-a-year therapy from day one. We are now preparing to advance this regimen into a registration-directed trial. Another exciting initiative is the development of a self-administered sub-Q Briondi. While the vast majority of patients continue to prefer to receive their anti-CD20 as an IV infusion, there is a growing minority who are now choosing a self-administered subcutaneous option, of which there is only one available today. we see a clear opportunity to expand access and choice with a self-administered subcube reality. Our ongoing phase one safety and bioclobin study is showing promising results. The subcube injection appears to be well tolerated with bioavailability that appears to support every other month or even potentially quarterly dosing. We're pleased with the progress so far and on track to launch a pivotal trial this year. We also believe that sub-q formulation may open new doors for us and new indications. One area that we are currently exploring is the potential for sub-q Brionvy and myasthenia gravis, and we're evaluating potential additional indications as well. Finally, on the pipeline front, we continue to be excited about AzorCell, our allogeneic CD19 CAR-T cell therapy. Its early days for CAR-Ts and autoimmune diseases but we see great potential across multiple indications. We're excited to launch our phase one for Azercel in progressive forms of MS, a segment of the MS population with limited treatment options and poor prognosis. In closing, 2025 is off to a very strong start. We're executing on our commercial strategy, advancing our clinical programs, and expanding our manufacturing capacity to meet the growing demand. I want to thank the entire TG team for their dedication and hard work. It's their commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS. And now I'll turn the call over to Adam Wallman, our Chief Commercialization Officer. Adam, go ahead.

Thanks, Mike, and good morning, everyone. I'm excited to share the details of another strong quarter of commercial execution. delivering meaningful growth and further validating our belief in the long-term potential of Briambi in the RMS market. U.S. net sales for Briambi in the first quarter of 2025 were approximately 119.7 million, exceeding our internal expectations and reflecting a strong start to the year, with 137% year-over-year growth and 16% sequential quarter-over-quarter growth. Based on this performance and the strength of leading indicators, we are increasing our full year 2025 BRIAMBI U.S. Net Revenue Guidance, which I will detail at the end of my remarks. We continue to see strength across our key performance drivers. The first three months of the year marked our highest months of total new patient enrollment since launch, a clear indication that demand continues to accelerate. This is despite the headwinds typically seen in the first quarter and an ongoing competitive product launch. Importantly, March was also our highest month ever for repeat prescribers, with physicians coming back to prescribe RE-MV again, a strong signal of growing prescriber confidence and satisfaction. Further, we saw continued strength in the hospital setting, which contributed approximately 60% of enrollments in March, the highest percent to date, highlighting our deepening footprint among institutional accounts. With this continued growth, for the first time, repeat prescriptions have now surpassed new prescriptions, a key inflection point in BreonV's lifecycle, demonstrating strong persistence trends at week 24 and week 48. While we remain in a competitive marketplace, BreonV continues to stand out. Our five-year data, consistent real-world safety and efficacy profile, combined with our unique one-hour, twice-a-year infusion, remain highly compelling to both physicians and patients. Importantly, we're seeing both an expansion of the CD20 market overall and continued dynamic market share gains for BRIOMB in the anti-CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switched patients. Additionally, from my point of view, the field team has executed with excellence. We've deepened our reach among high volume infusion centers, community neurologists, and leading academic institutions and we continue to receive positive feedback on our team from our customers. As we look ahead to the remainder of 2025, we are focused on several key growth drivers. First, continuing to accelerate uptake among community neurologists, academic, and broader practice types. Second, we will be launching our first ever direct-to-patient BrionB television commercial campaign, including full digital surround sound strategy to educate, inspire, and activate eligible patients to seek out 3MB treatment. Third, our teams will continue to build and leverage real-world evidence to support 3MB's position as a differentiated and trusted anti-CD20 option. And fourth, we will start preparing for lifecycle innovations, including our subcutaneous formulation, which we believe represents a significant long-term growth opportunity. In summary, we are off to a strong start in 2025. Our Q1 results reflect growing demand, increasing prescriber confidence, growing patient awareness, and broad commercial execution. Looking ahead, we are optimistic about the continued growth and potential of Brionvi. As I mentioned, based on current trends in both new patient accumulations and persistence, we are raising our full year 2025 U.S. net revenue guidance from $525 million, which we highlighted at JPMorgan in January, to $560 million for the full year 2025. Additionally, Q2 is already off to a strong start, with April being another record month for enrollments into our hub. And while we are still early into the quarter, we're currently targeting $135 million for the second quarter. With a robust foundation in place, multiple catalysts on the horizon, and a highly differentiated product, We believe, we believe Briambi is well positioned to become a market leading therapy in RMS. I want to thank our commercial team for their tireless commitment and drive. Your work is making a meaningful impact on the lives of people living with MS. We're proud of the momentum we've built and are more excited than ever about what lies ahead. And with that, I'll turn the call over to Sean to walk through our financials. Sean.

Thank you, Adam. And good morning, everyone. Earlier this morning, we reported our detailed first quarter 2025 financial results in a press release, which is available on the Investors and Media section of our website. I'd like to start today with a quick overview of our first quarter revenue, something Adam and Mike both already touched on briefly. We're very pleased to report U.S. net product revenue of $119.7 million for the first quarter of 2025. This reflects 137% growth compared to the same period last year and a 16% increase over the fourth quarter of 2024. This continued momentum underscores the strong demand that we're seeing for BRIAMBI. Turning to operating expenses, excluding non-cash items, our total OpEx for the quarter, which includes both R&D and SG&A expenses, came in at approximately $82 million for the quarter. That's tracking slightly ahead of our full-year guidance of approximately $300 million. This increase during the quarter was primarily driven by about $20 million in manufacturing investments for subcutaneous Breamby. We expect these costs charged to R&D to fluctuate from quarter to quarter. But importantly, we remain confident in our full-year OPEX guidance of approximately $300 million. On the bottom line, thanks to the continued strong performance of Briambi, we reported gap net income of approximately $5 million, or $0.03 per diluted share, for the quarter ended March 31st, 2025. And finally, a quick note on our balance sheet. We closed the quarter with $276 million in cash, cash equivalents, and investment securities. We believe this puts us in a strong financial position to continue executing our commercial strategy advancing our pipeline, and supporting our operations for the foreseeable future. Before concluding, I'd like to offer some initial perspectives on the recent discussions regarding potential tariffs. As you may know, Briambi is currently manufactured in South Korea. Given our relatively low cost of goods, we do not anticipate that the currently proposed tariffs will have a material impact on our gross margins or overall financial performance. Nonetheless, we are actively monitoring developments and evaluating all of our options. 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. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star 1 to register a question at this time. Today's first question is coming from Tara Bancroft of TD Cowan. Please go ahead.

Hi. Good morning, and thanks for taking the question. So I was hoping maybe you could provide a little bit more color on competitive dynamics, especially with Okra vs. Zenovo and Like, what are you seeing with competitive new patient share there? I asked because, you know, Roche had a small but meaningful miss this quarter, so I'm wondering what you're hearing, if anything, on preferred uptake of BRIAM-B in new patients versus other treatments. Thanks so much.

Adam, you want to go ahead and take that one?

Yeah, sure. You know, I think, as I mentioned in my comments, Tara, that we saw the highest three months ever in patient enrollments. We saw a really strong month in April. So we believe we're continuing to drive market share gains. We set back at J.P. Morgan, we think we're getting about 25% of the IV segment. We assume that's up from there, and we continue to see good traction in the marketplace, so really encouraged by what we're seeing. On the question on Zenovo, From what we can tell, we've seen zero impact on pre-empting.

Great. Thank you so much.

Thank you.

Thank you. The next question is coming from Michael DeFore of Evercore ISI. Please go ahead.

Hey, guys. Hope all is well. Thanks for taking my question. Just two for me. Just any update on gross-to-net trends this quarter, figuring how the Part D redesign may have affected this, and any comments on how this may affect gross-to-net for the balance of the year. And also, with regards to gross margin, when can we expect you to fully deplete, I guess, the pre-launch reserves in gross margin, and perhaps when can we expect maybe kind of a decrease in Thank you.

Adam, I'll take the GTN and maybe Sean the gross margin.

Sure. On the gross to net question, no material change in gross to net in the quarter. Part D redesign is not really relevant for our drug, which is a Part B drug. Sean?

Yeah, sure. Thanks, Mike. So we've fully depleted that pre-commercial inventory reserve that you're speaking of. So, you know, the margins you're seeing this quarter and going forward should be the fully baked number and consistent quarter to quarter.

Thanks. Thanks, Michael.

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

Great. Congrats for the quarter, and then thank you for taking our questions. So maybe the question related to the sub-Q of BreonV, you said you will start a pivotal this year. So just curious, what is the current thinking about how many doses you will move forward, and then when we will start to see the PK data second half? Thank you. Sure, thanks, Roger.

Yeah, I mean, we're still leaning toward having two dosing regimens in there, so the every other month and the quarterly as part of the pivotal. We still got a little time to make a final decision, but that's definitely where we're leaning today. And in terms of PK data coming out, you know, probably later this year. We just haven't been as focused, and we continue to collect more data. I think we're thinking we'll work on that study. It's going to lead us right into the trial, and then we'll figure out when we present some of the data. But again, I think we're being super conservative in having two dosing regimens in the pivotal trial. If we do that and if we don't do that, it's because we're so confident in one or the other.

Thank you. Thanks, Roger.

Thank you. The next question is coming from Mayank. Mantani of the Riley Securities. Please go ahead.

Yes, good morning. Thanks for taking our questions and congrats on the quarter. On the 30-minute infusion data that also we saw at ANN update, Mike, could you touch on the physician feedback there and also how might your data be tracking in depleted and non-depleted patients as you obviously try to understand the switch profile and enhance and broadly About your phase three trial, you know, scale and scope, if you could comment on that, that would be helpful.

Sure. So, you know, with respect to the 30-minute fusion, the feedback has been positive. Actually, maybe, Adam, you've talked to a lot of folks about that as well. You want to touch on the 30-minute fusion, any thoughts there? Okay.

Yeah, I think there's been very, very positive feedback on the 30-minute infusion. You know, physicians think it's a convenience for their busy infusion centers. Patients think it's a much more convenient option. And, you know, the data so far is showing that it's well tolerated. So it's been very positive, and physicians have encouraged us to continue to develop

Thanks, Adam. Yeah, so term. Sorry, did I cut you off, Adam?

No, no, go ahead. You were going to comment on phase three. And my question, the second part was actually around the R&D spend also, which seems like it's tracking higher. So, yeah, if you could factor in the phase three comments there, if that would start this year, for example. And then also, as you kind of commented on the SG&A spend, for second half, you know, given the DTC spend commitment, you know, if you could comment on how you're thinking about profitability going forward.

Yeah, Mike, you've got a lot in there. So I'll try to take it in a few steps and you can follow up if you like. But just in terms of the pivotal program, so I'll just be clear, there's two pivotal programs that we're planning. One is for the combined day one and day 15 dose. That study, again, should simplify the onboarding of patients. So we're looking at that 600 milligram, excuse me, 600 milligram dose on day one and no day 15. And that study, you know, should start hopefully in the next, you know, one, two, three months, the latest. So that's ongoing. 30-minute infusion is probably Something we're going to look at getting going later in the year or early next year. There's a little more logistics involved in that program than the 600 milligrams. In terms of the R&D spend that Sean mentioned, again, I think the only delta is just the materials that we have to produce to make the sub-Q that hit the R&D line instead of the CMC manufacturing line. I think in terms of our overall R&D spend, we're right on target to what we thought we'd be. And in terms of profitability, I'll let Sean discuss two or three things he could add. But I don't think we're highly focused on profitability this year. I think in terms of the way we view the world, we're not using cash. We should be driving cash through the business. But I don't think we're prepared to – to start targeting profitability and earnings per share on an ongoing basis. I think we'll stick to revenue guidance for now and some OPEX guidance. But we do have plans to not use cash during the course of the year, that's for sure. Is there something else I missed in there, Mike, or a few points?

You discovered it all. Thank you, Mike. And lastly, I have to ask a tariff question. How far along is your North Carolina plant in being able to produce commercial-scale manufacturing, if you could just update on that? And thanks for taking your own questions.

Yeah, you got it. Yeah, so, you know, moving manufacturing is not an easy task. And so... I think we've said it'll be several years before we'd be able to manufacture out of that North Carolina facility. So for the moment, I don't think it's a near-term event. It'll take several years, and I know the group is working on processes to get there, including potentially even starting out in Europe to perfect it while they're actually working on the facility here. So it's a long-term process. It was never really meant to. That all occurred, as everyone may remember, before any of this tariff talk. It was not a design program for avoiding tariffs. It was a design program to have backup manufacturing. So we're working on it as quickly as we can. But again, as Sean mentioned, I don't think we feel that we're going to be impacted too much from any of the tariff stuff, no matter what the final outcome is.

Understood. Thank you, Mike.

Thank you. The next question is coming from Eric Joseph of J.P. Morgan. Please go ahead.

Hi, guys. This is Ronon for Eric. Progress on the quarter. And just wanted to ask, I believe you previously cited expectations of about 20% product adherence between biannual infusions. Do you have a sense of that metric in Q1 and any anticipated fluctuations going forward? Thanks.

Sure. Adam, you want to grab that one?

Yeah, sure. Can you just clarify the question? I didn't hear the first, you said, did you, what was the percentage you said?

70% adherence between biannual infusions.

Yeah, I don't remember saying that, but what I would say is, you know, the persistence trends, as I said in my remarks, remain very much, very positive. And, you know, persistence remains strong and above our expectations.

Okay.

Thank you, guys.

Thank you. The next question is coming from Prakhar Adiral of Cantor Fitzgerald. Please go ahead.

Hi. Thank you for taking my questions, and congrats on the quarter. So, firstly, on sub-QB, where is the phase pivotal trial expected to start? I think previously you had mentioned targeting mid-year 2025 as the timeline. Is that still on track? And secondly, on a question on BrionV outside of MS, what do you need to see for BrionV's profile and indications like myasthenia gravis to make the decision to invest further, especially given you have seen some interesting data from the CD19 drugs in this space, especially Amgen's?

Yeah, thanks, Parker. So in terms of sub-Q, yep, still on track. As we said in the prepared remarks, still on track with the sub-Q timelines. And in terms of MG data, yeah, we're definitely moving cautiously forward in that area. We've been speaking to lots of KOLs. We keep reviewing the data. We'll get a chance to see how the CD19 is received in the marketplace. So I think we're not prepared to go diving into the pool just yet, but we've got more than a toe in, and we're continuing to evaluate. But I don't think it's one piece of information. I think there's an aggregate of information, and I don't think most of that information is necessarily related to our drug and the performance of our drug. I think it's more related to the marketplace and how things evolve. So we're going to stay on top of it. We're going to keep pushing forward at a moderate pace, with the ability to accelerate it at any moment we feel the time is right.

And maybe just one last question. What percentage of BMV patients right now are switches from Ocrevus? And is this a trend that you're seeing more of an infection this year? And if so, why is that the case?

Adam, you want to go ahead?

Yeah. You know, we haven't seen... You know, I wouldn't say we've seen material changes in the percent of switches. We still see a healthy amount of switches from Okravis, you know, and that trend has stayed consistent since launch. So no material change, and, you know, I'm sorry, I don't remember the second part of the question. Was there a second part? Okay, thanks.

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

Great. Thank you, Operator and everyone. Thanks for joining us. As you can see, we're off to a very strong start in 2025, and we're looking forward to keeping that momentum positive going forward into the rest of the year. We've got a number of key objectives that we're still looking to achieve and discuss on today's call. Of course, meeting our revenue targets that we've set, commencing pivotal trials for the simplified starting dose for IV BrionV and for sub-Q BrionV, as well as executing on our phase one trials for BrionV in patients with myosinus gravis and for azacel in patients with progressive forms of MS. Beyond that, we continue to evaluate opportunities to extend our portfolio of product opportunities across autoimmune and autoinflammatory diseases, and we'll continue our shared buyback program. In closing, I want to extend a heartfelt thank you to all the individuals living with MS and healthcare providers who place their trust in TG and Breon V. It's your courage that inspires everything that we do here at TG, so we really do appreciate it. And again, thanks everyone for joining us today. Have a nice day.

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