TG Therapeutics, Inc.

Greetings. Welcome to TG Therapeutics' second quarter earnings call and webcast. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference call over to Jenna Bosco, Chief Communications Officer. Jenna, you may now begin.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the second quarter 2025 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercial Officer, and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate development, Adam will share an update on our commercial 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 would 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 therapeutic 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 we'll be available for the next 30 days. Now, I would like to turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone, and thank you for joining us on today's call. I'm pleased to share that we delivered another strong quarter with solid performance across all aspects of our business, highlighted by the continued momentum of our flagship product, BrionV. The ongoing enthusiasm from the MS community has been both gratifying and energizing, and our commercial performance has exceeded expectations. At TG, our mission is to bring forward therapies that truly improve the lives of those living with multiple sclerosis. Hearing real-world stories from individuals on BrionV is both validating and deeply inspiring. I encourage you to visit briambi.com to hear some of these patient experiences firsthand. Our commercial team remains disciplined and highly effective in executing our multi-year launch strategy. As a result, adoption continues to grow. Now, approximately two and a half years into launch, we estimate that nearly one in every three new IV anti-CV20 patients or prescribed BrionV. This represents meaningful progress toward our long-term goal of making BrionV the most prescribed anti-CD20 therapy for relapsing MS, as measured by dynamic market share. And as adoption continues to grow, we remain focused on expanding choice and flexibility for patients and providers through the development of sub-Q BrionV and our enhanced study. The development of sub-QBRIAMBI represents a strategic opportunity to further build a leadership role in the anti-CD20 space. If approved, sub-QBRIAMBI would significantly expand our addressable market by unlocking access to the 35% to 40% of the anti-CD20 dynamic market segment that currently prefers a self-administered option, of which only one is available today. We believe SubQ-Briumbi has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position PG as the only company offering both an IV and a self-administered option, potentially simplifying the treatment decision for patients and providers and positioning Briumbi as the anti-CD20 therapy of choice. Supporting this vision, the team has executed exceptionally well on our clinical development goals this quarter, putting us on track to initiate patient enrollment into our pivotal phase three trial for sub-Q BrionV in the coming weeks. This study will evaluate two dosing schedules every other month and quarterly compared to IV BrionV in patients with relapsing forms of MS. The primary endpoint is to demonstrate non-inferior exposure between sub-Q dosing and our approved IV dosing. We anticipate completing enrollment in 2026, filing a BLA in 2027, and pending approval, launching a sub-Q BRIOMV in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIOMV. I'm pleased to report that within the enhanced trial, we have begun enrollment into a randomized, double-blind, phase three cohort, evaluating the potential to consolidate the day one and day 15 infusions into a single 600 milligram infusion on day one. The goal of this study is to establish comparable exposure between the two dosing schedules. If successful, this simplified approach would eliminate the need for a second infusion in the first two weeks. offering what we believe would be a meaningful convenience benefit for patients and infusion centers. We look forward to pivotal data in 2026 with the goal of an updated label in 2027. Turning briefly to our pipeline, we are also pleased to share that we have dosed our first patient with progressive MS using Azercel, our investigational allogeneic CD19-directed CAR-T therapy. In parallel, we continue to explore the use of BRIUMV in myasthenia gravis as we consider additional opportunities to expand the uses of BRIUMV. This is an exciting time at TG. Our results this quarter reflect strong execution across both commercial and clinical fronts and a growing confidence in BRIUMV from physicians and patients alike. With continued progress on our sub-Q programs, enhancements to the IV experience and the advancement of our CD19 CAR-T into the clinic, we're laying the groundwork for sustained leadership in the MS space. With that, I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, who will provide additional insights into our commercial performance and updated guidance for the second half of the year. Adam, go ahead.

Thank you, Mike, and good morning, everyone. I'm excited to report that Q2 2025 was another strong quarter for TG Therapeutics, marked by continued commercial momentum, executional excellence, and the highest number of new patient enrollments into our hub since launch. We're now seeing the tangible results of our strategic investments as the foundation we've built continues to scale. U.S. net sales for Briambi and Q2 totaled approximately 139 million, ahead of our internal expectations, and building on the robust growth we achieved in Q1, positioning us for a strong second half of 2025. Several key performance drivers reinforced our confidence in the brand's continued trajectory. We saw a meaningful increase in both new prescribers and new accounts, reflecting deeper penetration across academic institutions and community neurology practices. Q2 marked our highest volume of new patient enrollments to date, a clear indicator that our reach is expanding and that awareness among providers and patients is accelerating. We also continue to observe strong persistence and repeat prescribing, which we view as a validation of BRIAMBI's differentiated clinical profile and its value in real-world practice. Today, the CD20 class generates over $8 billion in annual US MS sales and continues to grow. BrionV is steadily increasing its share within this expanding market. As Mike mentioned earlier, we estimate that nearly one-third of new patients initiating IV anti-CD20 therapy are being prescribed BrionV. We believe there remains significant headroom for continued growth for the class and for BrionV within it. Our competitive advantage remains clear. A convenient twice-a-year, one-hour infusion combined with five-year safety and efficacy data, collectively offers a compelling treatment option for RMS patients. The differentiators continue to resonate strongly across care settings, from large academic centers to private practices to the VA system, where we continue to be the preferred anti-CD20 therapy. A major milestone this quarter was the launch of our first-ever national television campaign. This initiative is part of a broader multi-channel strategy that will ramp throughout the second half of the year with the goal of driving patient awareness. While it's still early, we're seeing promising signs of the investment as having an impact. Our latest market research shows a measurable uptick in patient awareness of Brand B. Website traffic, branded organic search impressions, branded paid search impressions, and qualified visitors to the website have all increased meaningfully. And importantly, physicians are reporting more patients requesting BRIAMBI by name. We are closely tracking key performance indicators across media channels and will continue to monitor performance, but early signals are encouraging. I also want to highlight the efforts of our commercial team. We believe we have a highly effective field team, and our recent surveys back that up with consistently high ratings when compared to our peers in the MS space. Their ability to clearly and credibly communicate BRIAMBI's value proposition is a key part of our strategy, and their daily commitment is making a real difference. Looking ahead, we are confident in the continued growth of BrainV revenues. Based on current trends in both new patient prescriptions and persistence of existing patients, we are again raising our full year U.S. BrainV net revenue guidance, which was $560 million to $570 to $575 million for the full year 2025. Similar to last year, given expected Q3 seasonality, we would expect stronger growth Q3 to Q4 than Q2 to Q3. With multiple growth drivers in place, expanding patient and prescriber bases, increasing brand recognition, and the momentum of our media investments, we believe Briambi is on track to become a multibillion-dollar brand in relapsing MS. To summarize, Q2 was another quarter of commercial strength execution, and strategic progress. We expect a strong second half of the year. With that, I'll turn it over to Sean to walk through the financials.

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed second quarter 2025 financial results via press release, which is available on the Investors and Media section of our website. Let's start by taking a closer look at our revenue performance. which continues to demonstrate strong growth and commercial momentum. We're very pleased to report total revenue of $141.1 million for the second quarter of 2025, which includes U.S. net product revenue of $138.8 million, representing a 91% increase compared to the same period last year and 16% growth over the first quarter of this year. This strong performance reflects the continued uptake and demand for BRAM-V and highlights our team's success and execution across the commercial landscape. Additionally, we recorded $2.3 million in license, milestone, and royalty revenue this quarter. Turning to our expenses, our total OpEx defined as R&D and SG&A costs excluding non-cash compensation totaled approximately 71 million for the second quarter of 2025. This represents an increase from 46.9 million in Q2 of 24, but a decrease of about 10 million compared to the first quarter of this year. The year-over-year increase was primarily driven by ongoing investments in R&D, particularly related to the development of a subcutaneous formulation of Breambic. as well as our continued commercial efforts on the SG&A side. In contrast, the sequential decline from Q1 was largely due to the timing of subcutaneous pre-MV development activities, which we expect will continue to have some quarter-to-quarter variability. With all that said, we continue to expect full-year operating expenses to be in the range of approximately $300 million in line with our prior guidance. On the bottom line, we're pleased to report GAAP net income of $28.2 million, or $0.17 per diluted share, for the quarter ended June 30, 2025, as compared to $6.9 million in net income, or $0.04 per diluted share, for the second quarter of 2024. And finally, a quick note on our balance sheet. We closed the quarter with approximately $279 million in cash, cash equivalents, and investment securities. which is essentially flat from the first quarter. We believe that strong capital position enables us to continue executing on our long-term strategy while preserving flexibility for future investments in our pipeline and operations. In summary, the second quarter was a success on multiple fronts, with strong results both operationally and financially. With that, I will now turn the call over to the conference operator to begin the Q&A.

Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question today, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. And our first questions are from the line of Tara Bancroft with TD Cowan. Please proceed with your questions.

Hi, good morning, and thanks for taking the questions. So I'm curious about guidance. You know, it applies a little bit of leveling off of growth in the back half of the year. So I'm curious to get your thoughts a little bit more elaboration on what various headwinds and tailwinds that we could expect in Q3 and Q4 to get a better idea of cadence for the rest of the year. Thanks so much.

Sure. Adam, do you want to take that one?

Sure, thanks for the question, Tara. You know, we're raising guidance here, and as I mentioned in the prepared remarks, you know, we do see seasonality in the summer. We accounted for that in the guidance, and we expect stronger growth from Q3 to Q4. And I think the success we've had in the first year with increasing enrollments and persistence in week 24 and week 48 are driving our need to increase the overall guidance for the year.

Okay, thank you.

Our next questions are from the line of Michael DeFiore with Evercore ISI. Please receive your questions.

Hey, guys. Thanks so much for taking my questions, and congrats on the strong quarter. Just two for me. I was wondering if you could expand upon comments you recently made at a broker conference where you said that 40% of CD20 new starts now opt for an at-home subqueue. My question is, how would you say the remaining 60% is broken down in terms of those opting for Briamvi versus the other competitors, IV and sub-Q formulations? And second question is, just given the growing payer push for lower-cost at-home therapies, are you seeing any early signs that the demand for sub-Q could actually outpace IV? And do you think that payers could accelerate that shift in the next year or two? Thank you.

Thanks, Mike. Adam, do you want to give a crack here? And I could always add on, but I think this one's right here, Will House.

Yeah, sure. Thanks for the question, Michael. So the first question, on the 60% that are IV, as I mentioned, we believe in the IV segment or physician-administered segment. We're capturing about one out of every three patients today, and the other competitors are getting the other part of that market. As far as the payer questions, we're not seeing it today, but certainly we could see it. It's certainly possible, hence the reason we are actively developing our own sub-Q to participate in that segment of the market.

Thank you.

The next question is from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.

Good morning. Maybe, could you talk a little bit more about the administration of the product you're developing with the auto-injector or pre-filter engine? What additional work do you need to do on the device side in terms of getting that to development?

Yeah, sure. Thanks for the question. So, yeah, so as typical for these kinds of programs, the main study will be conducted with the, uh, with basically a syringe pulled from a vial, uh, to get the bioequivalent. And then there's usually a bridging study to either pre-filled syringe and or to an auto injector. I think our plan is probably just go straight to the auto injector. Uh, and so there'll be a bridging study that's part of the program. Um, but that's all sort of in the timelines that we provide in terms of our target, uh, for a filing, uh, in 27 and hopefully, an approval in 28. But yeah, it starts off as injections from a vial and then bridges to the auto-injector. The auto-injector we're using is a, I call it relatively standard. It's been in tens of thousands of patients in multiple drug launches, multiple major drug launches. So it's a pretty well-known, pretty well-accepted auto-injector. And I think there's the basic development that goes along with that, but I don't think we're expecting any technical challenges with the auto-injector.

Thank you. Got it.

Our next question is from the line of Maya Quintani with B-Reilly Securities. Please receive your questions.

Yes, good morning. Thanks for taking our questions, and congrats on the progress. One more on the second half, revenue guidance. Could you touch on how you're assuming the anti-CD20 IV overall market trends, including your belief on how new patient starts might be trending for Zenovo Oculus? And then I have a quick follow-up.

Adam, you want to go ahead on this one too?

Sure. Sure. Yeah, thanks for the question, Mike. You know, we're not seeing a lot of enthusiasm for the Zenovo product in the U.S. You know, we continue. I think the biggest point here is that we continue to grow new patient enrollments. We've continued to grow through the launch. We've continued to grow through, you know, the ASP or the, I'm sorry, the JCO, the permanent JCO that was granted in April. So we're not really seeing any impact on us. in terms of, you know, there's a noble product, and we're seeing overall limited enthusiasm for that drug.

The overall market, do you think, is stable for IV and steadily growing, or is it just flat? Can you comment on that, Adam?

Yeah, sure. I think it's leveled out here at about 60, 40, 65, 35%.

Okay, thank you. And then on ECTRIMS, I believe in the same session we are getting the six-year ultimate one-and-two trial data set. We're also getting the anti-CD19 CAR-T, I believe a single-center primary progressive, you know, early data set. Mike, any thoughts on what your expectations are with some of the early human data that could inform your own Azure shell development?

Probably not so much. I mean, I think... all the data is going to be extremely early. And we'll see. I think those programs and our program are early. There's a lot of time to develop them. And I think in MS, it's not going to be a short-term kind of development program. So if anyone thinks they're going to do something relatively quickly there, they're probably, you know, maybe off-base, but we'll see. But anyway, I don't think there's going to be too much that's going to change how we think about how we're developing the drug. I think we've got a pretty clear focus on what we want to achieve, and we'll see if we can get there.

Thank you, Mike.

Thank you. Our next question is from the line of Roger Sange with Jefferies. Please proceed with your question.

Hi, this is Chachi Wang on for Roger. I had a question about whether you could touch on product adherence between the biannual infusions. And then my second question is, and maybe I missed this, if you could give 3Q guidance, perhaps I missed that in the beginning of your call.

Yeah, Adam, go ahead.

Sure. Can you please repeat the second half of that question?

So about 3Q guidance?

Yeah. Sorry, I didn't hear the last part of it.

I was just wondering, potentially I missed it, but did you guys give 3Q guidance? If not, could you give some color on that?

Yeah, no, we did not give 3Q guidance or Q3 guidance. We are giving full-year guidance similar to what we did last year. We gave you insight into what we feel is the growth trends from Q2 to Q3 and Q3 to Q4, but we're not giving specific Q3 guidance here.

Okay. Thanks. And then can you give some color on the product appearance part?

Sure.

In addition, thank you.

Sure. I mean, what we've seen is that our persistence continues to be good, both at week 24, and we're getting preliminary data here at week 48, continues to be above our expectations and, you know, slightly above where we would expect it to be based on published data that's out there, or other CD20s, that is.

Thank you.

Thank you. The next question is from the line of Prakhar Agarwal with Kendra Fitzgerald. Please proceed with your question.

Hi, thanks for doing my question, and congrats on the quarter again. So firstly, on the subcute brain, it seems that you're also comfortable with the quarterly dosing here. Maybe if you can comment on what you saw in phase one for the quarterly dosing frequency, and what will be injection volume for both quarterly and every other month dosing? Also, when can we see the subcute phase one data? And I have a follow-up.

And you have a follow-up, okay. Thanks, Parker, for the question. On the sub-Q dosing, yeah, I mean, look, in terms of quarterly dosing and every other monthly dosing, you know, we've got preliminary bioavailability information that leads us to believe that both are achievable, certainly every other month and quarterly as well. We haven't provided that information just yet. In terms of volume, typical autoinjecta is max, you know, basically 2 mLs of volume, so we'll probably be pretty close to that. But, yeah, I think for the moment what we've said is, you know, we're comfortable that what we've seen with the bioavailability, it should support every other month and, as I said in the prayer remarks, potentially quarterly as well. And you have a follow-up?

Yeah, got it. Thanks, Mike. So on the second quarter sequential growth of 16%, how much is volume versus pricing? And if you can comment on the growth to net trends for the rest of the year. Thank you so much.

Sure. Yeah, I think that's going over to Adam.

Sure. Thanks for the question, Parker. You know, on the growth to net, I'll take that first. We've guided 70% to 75% for the year, and that still remains intact. I would say this quarter it was probably closer to 70%. And the reason for that is that our fastest-growing segment is the hospital segment, and we continue to see growth in that segment of the market. And with that comes mandated government discounting or more exposure to government-mandated discounting. like 340B discounting, which can affect your gross net. So we did see gross net probably closer to 70 in this quarter, but the guidance that I've given for the year between 70 and 75% is still accurate, but in this quarter it was probably closer to 70. And was there any, what was the second part of that question?

Yeah, how much of the 16% sequential growth is volume versus price?

Yeah, I don't have that exactly broken down, but mostly volume.

Thank you.

Thank you. At this time, we've reached the end of the question and answer session. I'll turn the call over to Mike Weiss for closing remarks.

Thank you very much, Operator, and thank you all again for joining us today. As you've heard, this quarter highlights the strength of our commercial execution, the growing demand for BrionVe, and significant opportunity ahead as we continue to expand our presence in MS. We believe TG is well-positioned to drive meaningful near-term growth while also shaping the future of MS care through differentiated options across IV, sub-Q, and potentially cell therapy, laying the foundation for sustained growth and long-term shareholder value. Most importantly, our focus remains firmly on delivering for patients, and we look forward to keeping you updated on our continued progress in the quarters ahead. Thanks again for joining us and have a great day.

Thank you. This will conclude today's conference. Let me disconnect your lines at this time. Thank you for your participation.