TGTX - NASDAQ

Greetings. Welcome to TG Therapeutics' Second Quarter Earnings Call and Webcast. [Operator Instructions] 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 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 will 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 BRIUMVI. 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 BRIUMVI is both validating and deeply inspiring. I encourage you to visit briumvi.com to hear some of these patient experiences firsthand. Our commercial team remains disciplined and highly effective in executing our multiyear launch strategy. As a result, adoption continues to grow, now approximately 2.5 years into launch, we estimate that nearly 1 in every 3 new IV anti-CD20 patients are prescribed BRIUMVI. This represents meaningful progress for our long-term goal of making BRIUMVI 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 subcu BRIUMVI in our ENHANCE study. The development of subcu BRIUMVI represents a strategic opportunity to further build a leadership role in the anti-CD20 space. If approved, subcu BRIUMVI 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 subcu BRIUMVI has the potential to offer a highly valued alternative for both patients and providers. Moreover, it would uniquely position TG as the only company offering both an IV and a self-administered option, potentially simplifying the treatment decision for patients and providers and positioning BRIUMVI 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 III trial for subcu BRIUMVI in the coming weeks. This study will evaluate 2 dosing schedules every other month and quarterly. Compared to IV BRIUMVI in patients with relapsing forms of MS. The primary endpoint is to demonstrate non-inferior exposure between subcu dosing and our approved IV dosing. We anticipate completing enrollment in 2026, filing a BLA in 2027 and pending approval, launching a subcu BRIUMVI in 2028. At the same time, we're focused on enhancing the patient experience with IV BRIUMVI. I'm pleased to report that within the ENHANCE trial, we have begun enrollment into a randomized, double-blind Phase III cohort evaluating the potential to consolidate the day 1 and day 15 infusions into a single 600-milligram infusion on day 1. The goal of this study is to establish comparable exposure between the 2 dosing schedules. If successful, a simplified approach would eliminate the need for a second infusion in the first 2 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 azer-cel our investigational allogeneic CD19-directed CAR-T therapy. In parallel, we continue to explore the use of BRIUMVI in myasthenia gravis as we consider additional opportunities to expand the uses of BRIUMVI. 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 BRIUMVI from physicians and patients alike. With continued progress on our subcu program, 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 BRIUMVI in 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 reinforce 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 BRIUMVI's differentiated clinical profile and its value in real-world practice. Today, the CD20 class generates over $8 billion in annual U.S. MS sales and continues to grow. BRIUMVI is steadily increasing its share within this expanding market. As Mike mentioned earlier, we estimate that nearly 1/3 of new patients initiating IV anti-CD20 therapy are being prescribed BRIUMVI. We believe there remains significant headroom for continued growth for the class and for BRIUMVI within it. Our competitive advantage remains clear, a convenient twice a year, 1-hour infusion, combined with 5-year safety and efficacy data collectively offers a compelling treatment option for RMS patients. These 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 multichannel 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 is having an impact. Our latest market research shows a measurable uptick in patient awareness of BRIUMVI. 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 BRIUMVI by name. We are closely tracking key performance indicators across media channels, and we'll 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 backed that up with consistently high ratings when compared to our peers in the MS space. Their ability to clearly incredibly communicate BRIUMVI'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 BRIUMVI revenues. Based on current trends in both new patient prescriptions and persistence of existing patients, we are again raising our full year U.S. BRIUMVI net revenue guidance which was $560 million to $570 million 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 BRIUMVI 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 BRIUMVI 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 noncash 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 BRIUMVI, 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 BRIUMVI 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 '24. 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 this 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.

[Operator Instructions] And our first questions are from the line of Tara Bancroft with TD Cowen.

So I'm curious about guidance. It implies 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.

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

Sure. Thanks for the question, Tara. We're raising guidance here. And as I mentioned in the prepared remarks, 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 increased enrollments and persistence in week 24 and week 48 are driving our need to increase the overall guidance for the year.

Our next questions are from the line of Michael DiFiore with Evercore ISI.

Congrats on the strong quarter. Just 2 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 subcu. My question is, how would you say the remaining 60% is broken down in terms of those opting for BRIUMVI versus the other competitors, IV and subcu formulations? And second question is just given the growing payer push for lower-cost at-home therapies, like are you seeing any early signs that the demand for subcu could actually outpace IV? And do you think that payers could accelerate that shift in the next year or 2?

Thanks, Mike. Adam, do you want to give a crack here and I could always add on, but I think this one is right in your warehouse.

Yes. 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 1 out of every 3 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 subcu to participate in that segment of the market.

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

Maybe could you talk a little bit more about the administration of the subcutaneous product you're developing, will it be auto-injector or prefilled syringe? And what additional work do you need to do on the device side in terms of getting that -- the development through to outperform?

Yes, sure. Thanks for the question. So yes, so as typical for these kinds of programs, the main study will be conducted with the -- basically a syringe pulls from a vial to get the bioequivalent. And then there's usually a bridging study to either a prefilled syringe and/ or to an auto-injector. I think our plan is probably just go straight to the auto-injector. And so there'll be a bridging study that's part of the program. But that's all sort of in the time lines that we provided in terms of our target for a filing in '27 and hopefully, an approval in '28. But yes, it starts off as injections from a vial and then bridges to the auto-injector. The auto-injector we're using is a, 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.

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

Yes. 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

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

Sure. Yes. Thanks for the question, Mike. We're not seeing a lot of enthusiasm for the

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

Yes, sure. It's about -- I think it's leveled out here at about 60 -- 60-40, 65-35.

Okay. And then on ECTRIMS, I believe in the same session, we are getting the 6-year ULTIMATE I and II trial data set, we're also getting the anti-CD19 CAR T, I believe, a single center, primary progressive early data set. Mike, any thoughts on what your expectations are with some of the early human data that could inform your own azer-cel 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 any of the things they're going to do something relatively quickly there. They're probably maybe off pace. But we'll see. But anyway, yes, 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.

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

This is Cha Cha Yang on for Roger. I had a question about whether you could touch on product adherence versus the biannual infusions. And then my second question is, maybe I missed this, if you could give 3Q guidance, perhaps I missed that at the beginning of your call.

Yes. Adam, you want to go ahead...

Can you please repeat the second half of that question?

So about 3Q guidance?

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

I was just wondering, potentially, I missed it, but did you guys give Q3 guidance? If not, could you give us some color on that?

Yes. 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 trend from Q2 to Q3. And in Q3 to Q4, but we're not giving specific Q3 guidance here.

Okay. And then can you give some color on the product adherence part versus the infusions.

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 slightly above where we would expect it to be based on published data that's out there for other CD20s that is.

The next question is from the line of Prakhar Agrawal with Cantor Fitzgerald.

Congrats on the quarter again. So firstly, on the subcu BRIUMVI, it seems that you're also comfortable with the quarterly dosing here. Maybe if you can comment what you saw in Phase I for the quarterly dosing frequency? And what will the injection volume for both quarterly and every other month dosing? Also, when can we see the subcu Phase I data? And I have a follow-up.

And you have a follow-up. Okay. Thanks, Prakhar for the question. On the subcu dosing, yes, I mean, look, in terms of quarterly dosing and monthly -- and every other monthly dosing, 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 auto injectors, max, basically 2 mls of volume, so we'll probably be pretty close to that. But yes, I think for the moment, what we've said is we're comfortable that what we've seen with the bioavailability it should support every other month, and as I said in the per pared remarks, potentially quarterly as well. And you had a follow-up?

Yes. Got it. So on the second quarter sequential growth of 16%, how much is volume versus pricing? And if you can comment on the gross net trends for the rest for the year.

Sure. Yes. I think that's one for Adam.

Sure. Thanks for the question, Prakhar. On the gross 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 we -- our fastest-growing segment is the hospital segment, and we continue to see growth in that segment of the market. And with that comes a mandated government discounting or more exposure to government mandated discounting, like 340B discounting, which kind of affect your gross to net. So we did see gross to 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 that the -- was there any -- what was the second part of that question?

Yes. How much of the 16% sequential growth is volume versus price?

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

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 BRIUMVI and a 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, subcu 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.