TGTX - NASDAQ

Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2025 Earnings Call. [Operator Instructions] Please note, this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Chief Communications Officer. Please proceed.

Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' Fourth Quarter and Year-end 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 begin with an overview of our recent corporate developments. Adam will provide an update on our commercial efforts, and Sean will review our financial results before we open the call for Q&A. Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include expectations regarding our future operating and financial performance, including sales trends, revenue guidance, projected milestones, development plans and outlook for our marketed products. Please note that these statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated. These risks are detailed in our SEC filings. Additionally, any forward-looking statements made today reflect our views only as of this date, and we disclaim any obligation to update or revise them. As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our corporate website at www.tgtherapeutics.com. With that, I'll turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone, and thank you for joining us today. 2025 was a defining year for TG Therapeutics. We didn't just grow, we scaled, we strengthened and we demonstrated that BRIUMVI is becoming a foundational therapy in relapsing multiple sclerosis. Let's start with what matters most, performance. We delivered approximately $616 million in total global revenue, the vast majority of which came from $594 million of BRIUMVI U.S. net sales, and we capped the year with a strong fourth quarter of $183 million. That represents approximately 92% year-over-year growth and 20% sequential growth from Q4 over Q3. Those numbers reflect something simple. Physicians are choosing BRIUMVI, patients are staying on BRIUMVI and confidence in the product continues to build. That confidence is reinforced by our 6-year open-label extension data from ULTIMATE I and II presented at ECTRIMS this past September. Nearly 90% of the patients were free from 24-week confirmed disability progression after 6 years of continuous treatment, 6 years and the relapse rate seen in the 6-year BRIUMVI treatment translates into 1 relapse occurring in every 83 years of treatment. And importantly, no new safety signals emerged. On the R&D front, we advanced our Phase III ENHANCE study, evaluating consolidation of the day 1 and day 15 BRIUMVI infusions into a single 600-milligram dose. Enrollment is complete. We expect top line data midyear with the potential 2027 launch of this consolidated treatment schedule. If successful, this could meaningfully simplify the treatment experience. We believe effective therapies should not only work well, but be as convenient as possible for patients, which brings me to our subcutaneous program. We are developing a self-administered at-home subcu BRIUMVI to be delivered via an auto-injector. Our Phase III study is evaluating 2 dosing schedules, every 2 months and quarterly administration. The trial is now approximately 75% enrolled, and we're targeting pivotal top-line data later this year or early next year with a potential 2028 launch. We see this program as having significant commercial potential. The subcu portion of the anti-CD20 market is substantial and being able to compete in this space, we believe, could nearly double our total addressable market opportunity. Beyond MS, we are actively advancing plans to explore BRIUMVI in additional autoimmune indications, including having treated a series of Myasthenia Gravis patients in a Phase I study. And finally, Azer-cel, our allogeneic anti-CD19 CAR-T is being studied in patients with progressive MS. It's still early, but momentum is building. Our clinical trial sites are identifying patients quickly. In fact, demand is exceeding available trial slots. That tells us something important. There is a real unmet medical need. We look forward to sharing updates from this program later this year. Turning to some financials. I'll leave the details to Adam and Sean, but suffice to say, we expect to continue generating positive cash flow in 2026 and beyond, which gives us a rare financial flexibility within the biotech universe. We've been clear about our capital priorities, invest to maximize the multibillion-dollar BRIUMVI opportunity, expand the pipeline judiciously for sustained future growth, repurchase shares when we believe TG is materially undervalued and otherwise allocate capital in ways that generate long-term returns. With respect to share buybacks, we completed our first $100 million share repurchase program, and the Board authorized an additional $100 million last year. At current levels, we view our shares as significantly undervalued relative to the cash flow profile we expect over the coming years, and we will not hesitate to act accordingly, including adding leverage to reduce our share count. And to be clear, we purchased shares to create long-term value, not for the optics. Before closing, I want to touch on something I'm personally very proud of. Many of you saw Christina Applegate launched Next In MS during Super Bowl 60. We are honored to partner with her on this platform. Next In MS is about honest, unfiltered conversations about life with MS, about difficult realities about resilience beyond treatment decisions. We're not just commercializing BRIUMVI. We're building the MS company that shows up for patients beyond the prescription. To close, at TG, our mission remains simple: deliver meaningful therapies, simplify treatment, create lasting value for patients and shareholders. I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, for a detailed commercial update. Adam, go ahead.

Thanks, Mike, and good morning, everyone. 2025 was a year of continued acceleration for BRIUMVI, and we closed the year with another strong quarter of execution and growth, further expanding our position in the RMS market. For the fourth quarter of 2025, we delivered U.S. net sales of $183 million and continued sequential expansion versus Q3. For the full year, BRIUMVI U.S. net revenue reached $594 million, reflecting sustained momentum built on the strong commercial foundation established in the first 3 years of launch. Growth throughout the year was driven by consistent and increasing year-over-year new patient starts, continued expansion of our prescriber base, better-than-expected persistence, greater depth within high-volume infusion accounts. Importantly, growth was broad-based across both academic and community settings, reflecting rising physician confidence and expanding utilization. BRIUMVI continues to strengthen its competitive position within a large and growing anti-CD20 market. Within the IV anti-CD20 segment, we continue to gain dynamic share. Physicians remain focused on proven efficacy, long-term safety experience and operational efficiency and BRIUMVI's 1-hour twice yearly maintenance infusion profile supported by multiyear data continues to resonate in a competitive environment. We are seeing a balanced mix of treatment-naive and switch patients, reinforcing both the breadth of the opportunity and the continued expansion of our footprint within the class. Our execution remains strong across all commercial functions, and TG is emerging as a leader in the therapeutic category. As the franchise continues to scale, we have continued to invest behind the business. During 2025, we expanded our field organization to deepen coverage in high-opportunity geographies and broaden our reach among community neurologists and independent infusion centers. That expanded footprint is driving increased prescriber engagement and positions us to accelerate further penetration in 2026. We also expanded our direct-to-patient engagement efforts during the year. In addition to our national BRIUMVI campaign, as Mike mentioned, we recently announced our partnership with Christina Applegate to launch NextInMS.com, a new educational platform designed to provide resources and information to individuals living with RMS and their caregivers. Christina's long-standing advocacy within the MS community brings credibility and visibility to broader conversations around navigating life with MS. Through Next In MS, our focus is on education, empowerment and encouraging informed dialogue between patients and their health care providers. As BRIUMVI continues to scale, we believe it's important to engage thoughtfully and meaningfully within the MS community, and this partnership reflects our growing leadership position in the space and our long-term commitment to supporting the MS community. As we look to 2026, we are reaffirming our previously issued full year U.S. BRIUMVI net revenue guidance of $825 million to $850 million, with total global revenue at $875 million to $900 million. Our outlook reflects continued growth driven by expanding prescriber adoption, increasing depth within existing accounts and ongoing share gains and a growing installed base of patients with strong persistence on therapy. We've entered 2026 with real momentum. New patient starts are tracking to our strongest level since launch. Physician confidence continues to build and our share trajectory within the IV anti-CD20 segment remains favorable. Importantly, after operating alongside competitive entrants for several quarters, BRIUMVI has demonstrated that it can compete effectively and continue to expand its position within the class. Turning to the first quarter and based on the strong demand trends we are seeing earlier in the year, we expect U.S. revenue to grow sequentially over Q4 levels to approximately $185 million to $190 million, even after accounting for typical seasonal headwinds. As we have mentioned previously, the first quarter generally reflects routine factors such as benefit reverifications and gross to net variability driven by deductible resets, which can influence the timing of net revenue early in the year. These dynamics are consistent with what we have seen historically in the category and are fully incorporated into our full year guidance. We also expect ex-U.S. revenue to be in the range of $5 million to $10 million for the first quarter. Taken together, the strength of demand and continued share expansion gives us confidence in our reaffirmed guidance and our ability to drive meaningful growth in 2026. To summarize, we have delivered another year of strong growth in 2025. We continue to gain share in a competitive IV anti-CD20 market. We have invested meaningfully in field expansion and direct-to-consumer initiatives to support the next phase of growth. We are off to a very strong start in 2026, tracking to record new patient enrollments entering the year. BRIUMVI is now a scaled and expanding franchise, and we believe the commercial platform we've built positions us well to continue driving meaningful growth in the year ahead. With that, I'll turn it over to Sean to walk through the financials.

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we released our fourth quarter and full year 2025 financial results, which are available in the Investors and Media section of our website. I'll begin with a discussion of our revenue for the fourth quarter and full year, which Adam briefly touched on. We are pleased to report U.S. BRIUMVI net product revenue of $182.7 million during the fourth quarter. Total net product revenue for the quarter was $189.1 million, which includes $6.4 million of product revenue related to sales to our partner, Neuraxpharm in support of ex-U.S. commercialization. For the full year 2025, global revenue was approximately $616 million, predominantly comprised of $594 million in U.S. BRIUMVI net product revenue, $12.8 million in revenue from products supplied to Neuraxpharm and $9.4 million in royalty and other revenue. Our gross margin for the quarter was slightly below typical as a result of timing of sales to our ex-U.S. partner and a onetime inventory reserve. Shifting to operating expenses, which we define as R&D and SG&A, excluding noncash comp. Full year 2025 expenses totaled approximately $328 million, in line with our prior guidance of $300 million to $320 million. The modest variance was driven primarily by incremental manufacturing and development costs related to subcutaneous BRIUMVI and continued commercial investment. Revenue growth significantly exceeded the increase in operating expenses, resulting in operating income of $123 million for the year. For the fourth quarter, net income was $23 million or $0.14 per diluted share. For the full year 2025, net income totaled $447.2 million or $2.77 per diluted share compared to $23.4 million or $0.15 per diluted share in 2024. As a reminder, 2025 results including nonrecurring income tax benefit of approximately $340 million, which relates primarily to the release of our deferred tax asset valuation allowance in the third quarter. Turning to our balance sheet and capital position. We ended the year with more than $600 million in current assets, approximately $200 million in cash, cash equivalents and investment securities, $300 million in accounts receivable and $140 million in inventory. During the year, we completed our previously authorized $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share. The Board has since authorized an additional $100 million share repurchase program, reflecting continued confidence in our long-term outlook. Looking ahead to 2026, we expect full year operating expenses of approximately $350 million, excluding noncash comp, plus approximately $100 million in expenses associated with subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up activities. These costs run through R&D today, but if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods as the manufacturing expense has already been recognized, positively impacting gross margin in future periods. In summary, 2025 represented a year of strong execution for TG. We delivered substantial revenue growth, generated meaningful operating income and positioned the company for continued expansion in 2026. With that, I will now turn the call back over to the conference operator to begin the Q&A.

[Operator Instructions] The first question comes from Michael DiFiore with Evercore ISI.

2 for me. Roche has recently highlighted accelerating subcu uptake in community practices and Novartis continues to emphasize strong growth in the -- in self-administered first-line use. You've described broad momentum across academic and community settings in the HCP administered segment. So my question is, can you help us think about how those dynamics fit together and where you're currently seeing the strongest incremental momentum by site of care? And I have a follow-up.

Sure. Thanks for the question. Adam, do you want to go ahead?

Yes, sure. Thanks for the question, Mike. So listen, we've now operated alongside the new entry from Roche for several quarters now. We continue to seek share gains in the IV segment. Physicians seem to be -- continue to be driven by clinical data, long-term data, operational considerations. It seems like the majority of the de novo business seems to be coming from Ocrevus IV. But importantly, we're also -- we're not seeing any decreases in the switches from Ocrevus to BRIUMVI. So that's an important factor, too. And in terms of what's driving our share, we're seeing growth across both private practice and academic centers. We think it's the durability of the clinical profile, as Mike mentioned, the 6-year data, especially the safety data within there and the efficacy data. We continue to believe the operational advantages of BRIUMVI, the 1-hour infusion, the twice a year are relevant for patients and infusion centers. We continue to expand prescriber breadth and depth with our expansion of our field force. And I think we're seeing great momentum. And as I mentioned, the underlying demand is very strong. Enrollments are tracking to the highest since launch. And we continue to see share gains across the board, across patient types, across sites of care. And importantly, also, we see very strong persistence. So overall, really strong and the fundamentals are great.

Very helpful. And my follow-up question is on gross to net. You previously noted that gross to net can fluctuate with site of care mix, particularly in hospital exposure. So as these -- as growth evolves across channels, are you seeing any meaningful change in gross to net assumptions? Or does your prior framework still hold?

Yes. As I mentioned in the prepared remarks, gross to net can vary quarter-to-quarter. In Q1, gross to net is influenced by deductible resets and high utilization of co-pay programs. Consistent with what we've seen historically, does not represent a structural change in how we think about gross to net. It's a Q1 dynamic. Our full year guide reflects the net revenue profile for this year. It is a Q1 dynamic that seems to be consistent with what we see across the CD20 space, also other specialty products, and it's fully baked into our full year guidance. So I hope that answers the question.

The next question comes from Tara Bancroft with TD Cowen.

So I'm curious to hear your thoughts around positioning now that you're several years into this launch, but guidance for Q1 and the year are pretty conservative. So I was hoping you could give us some more detail on the proportion of new versus switch patients and how much revenue now is from patients that are remaining on treatment for these extended periods of time and whether new patient starts are still growing or leveling off and why?

Thanks. Adam, it's all you still.

Go ahead. Yes. Thanks for the question, Tara. Listen, I think I'll just reiterate what we're seeing. The majority -- we're seeing record new patient enrollments here. We're still seeing growth. We're seeing great share gains in the IV segment. And I think that's being driven by the things that I mentioned, durability of the clinical profile, the 6-year data, the operational advantages, our investment in both the expansion of our field force. It could very well be our DTC efforts, although hard to single out a single factor here. But all these things, I think, are leading to continued confidence in the product across the board, and that's why we're seeing such a great demand that we're seeing right now. As far as new versus switch, I mentioned a couple of quarters ago, the business becomes more predictable as we've now walked into more switch. Sorry, not switch, repeat patients. So we are seeing more and more repeat patients as a bigger part of our business as that patients continue to pancake from quarter-to-quarter and stay on therapy for long periods of time. As I mentioned before, also, our persistence is quite strong. And so we're seeing patients staying on therapy for -- it looks like out to week 48, week 72, week 96 seems very good. So all those things are leading to growth. We do expect -- we do expect growth in 2026 and meaningful growth in our guidance.

The next question comes from Prakhar Agrawal with Cantor Fitzgerald.

Congrats on the quarter. Maybe just a follow-up on the new patient start. Adam, you said you're seeing good growth in new patient starts, but I'm trying to connect the dots between your commentary as well as what's implied in the guidance because based on our math, the guidance would imply a more modest year-on-year growth on new patient starts. So how much conservatism is baked into the guidance? Or should we expect a lot higher gross to net for full year 2026? And secondly, how much incremental investments would you need for the subcu launch? And what would be the plans to commercialize subcu BRIUMVI ex-U.S. given that it seems to be a large market for drugs like Kesimpta, so there could be a lot of value there.

Yes. Mike, do you want me to continue to go here?

Yes. Why don't you and just start off. Go ahead.

Yes. I mean, look, we're early in the year here. Like I said, we're seeing a strong start to the year. We're early here. We'll continue to update the guidance as we see fit, as we continue to get more time with -- we'll see how we do throughout the year. It's, of course, possible that we could see outperformance that could come from continued new patient starts. We could see incremental share gains. We could see better-than-expected persistence. That's -- we're being somewhat conservative here. But so far, the year is starting are strong, but we're -- again, we're only in February. So we'll see how that goes. And then in Q1, we're seeing just a disconnect in Q1 prior to your question, strong new patient growth. However, you do face the Q1 issues and headwinds as I described on gross to net and benefit reverification. And then Mike, I don't know if you want to take the subcu question.

Sure. Yes. I mean in terms of incremental investment, Prakhar, I mean, Adam can answer this as well as me, but overlap between our current field force for IV to subcu is, I think, about 80%. So I don't -- there's not a huge incremental cost. There will obviously be some incremental marketing costs associated with it. But overall, it's not a huge incremental investment to launch subcu in the U.S. As for ex-U.S., we expect our partners at Neurax will opt into that program when offered it. And so we'll work with them on the ex-U.S. strategy at that point.

The next question comes from Corinne Johnson, Goldman Sachs.

Maybe continuing on the conversation on subcu. Some of the competitors started providing color on the role I think a subcu offering could play over time with respect to IV versus subcu share. I guess what is your perspective there, particularly given the variety of dosing options within subcu that could be coming over the next couple of years, including obviously, BRIUMVI?

Sure. I'll give it a start, Adam, you can supplement if you like. Look, the subcu portion of the market has been relatively stable for a while, I think 35% to maybe 40% it fluctuates up and down quarter-to-quarter. Long term, the more options that are available creates more energy in that space and more people marketing in that space. So I do believe that over time, with new options available, that space can expand and probably will expand. To what extent is hard to predict at this moment, but I do think there's probably some forces that will push people towards subcu at home over time. And yes, so I do think that market will continue to -- Adam, any additional thoughts?

No, that's perfect. Sean.

The next question comes from Brian Cheng with JPMorgan.

Just looking at the existing sales force, is there any potential need for a refocus of their goal this year? And are there pockets of opportunities that you think might be more important this year just given more adoption on the subcu side? And then on a related note, how should we think about the expenses projection related to the DTC campaign that you have set up for this year? What magnitude of a step-up can we expect?

Thanks, Brian. Adam, do you want to lead us off here?

Sure. Yes. Thanks for the question, Brian. We -- as I've mentioned before, we continue to take a strategic expansion approach to our field force. We have continued to add people as we've seen opportunities to do so. We're looking at it strategically. We add people where we see opportunity and continue to hire the best people that we can find in the area. As far as a new goal, I don't know that it needs a new goal. I think we have a pay-for-performance culture and an accountable culture. We've hired the best people in the industry. This team is fantastic, and they continue to deliver on what we've asked them to do. So I don't think we need a new goal. I think we have a great team. I'm very confident in the commercial functions, as I mentioned, I think they're doing an excellent job.

The next question comes from William Wood with B. Riley.

So thinking about some of your -- the subcu Phase III that's going on currently. I'm just curious when we might actually see or if there's a chance that we might see any subcu bioequivalence data generated. So how we can sort of think about that, the Phase III readout later this year? And then also in terms of some of the earlier-stage programs, I know you've got Phase I ongoing in Myasthenia Gravis. But just curious if and when we might expect to see some of these earlier stage data from the earlier-stage programs, any of that reading out later this year at conference?

Sure. Thanks for the question, William. In terms of subcu, yes, as we discussed, Phase III is approximately 75% enrolled. We continue to be excited about that program and it's -- the opportunity for us there. Phase III data is expected later this year or early next year. In terms of the Phase I bioequivalence data, it's been coming in. The study is actually, I think, just about to close formally. So there's overlap between the Phase III and the Phase I just for follow-up and all those kinds of things. So the Phase I is, I think, just about closing up or maybe it's not there yet, but getting close. We'll take a look at the timing of conferences and the timing of the Phase III data and see if it makes sense to actually put the Phase I data out or not based on timing of where we are at the Phase III and the conference schedule that's available once that data is fully evaluated and presentable format. So the answer is, I don't know as of yet. But like I said, based on the preliminary data, we're feeling very good about the program and very excited about the Phase III outcome that will be later this year. In terms of Phase I MG, I have not talked to the team yet about what their plans are for presenting that information. Anecdotally, I know the study -- the patients who have been treated with MG look quite good in terms of their response to the drug, which I don't think is much of a surprise to anybody. But I'll check back with the team and I'll be able to give some more guidance later on that once I find out what their plans are.

The next question comes from Emily Bodnar with H.C. Wainwright.

In terms of the ENHANCE trial and launching that next year, can you just talk about how you think about that from a market perspective and if you see any potential for kind of incremental revenue growth with implementing that launch? And then maybe if you could just talk a bit about some early metrics that you're tracking with the DTC launch and the Next In MS program?

Sure. Thanks for the question, Emily. So in terms of the ENHANCE trial launch and incremental potential from that, I'll take a crack, Adam, and then please jump in. We've done some market research. Generally speaking, it's extremely positive feedback on eliminating the second dose, the convenience factor for both patient and for centers is viewed very high in the research we're doing. Anecdotally, I've personally been in advisory boards recently where people are even more enthusiastic than they've previously been about reducing that first dose. In terms of incremental market share gains, I think from our research and from the anecdotal experience that we have, we do believe that it will help us continue to gain market share gains in this area. Again, it's just -- every time we make it easier, it's just -- it's better. In terms of -- the other side of it is in terms of switches, people are excited about it to use this on label for switches, which we think will be helpful there. And generally speaking, if you're looking at going on IV OCREVUS or IV BRIUMVI, you now have another reason or another convenience reason to go on to BRIUMVI, eliminating that first dose, which they still have -- we'll still have 2 doses upfront for their IV plus the much longer infusion. So yes, we do think that will have a positive impact, and we're looking forward to that launch. Adam, anything more on that topic?

No, I think you covered it. That was great.

Okay. And then the second part of the question was early metrics on DTC. I know that's one of Adam's favorite topics, so I'll hand it off to him.

Yes. No, thanks for the question, Emily, and asking about our partnership with Christina and Next In MS. As I mentioned, we view these efforts as building long-term category leadership. The feedback from customers and patients and advocacy groups has been incredibly positive. so far. Obviously, we're looking at in terms of metrics that you asked about, the engagement with the content has been -- has exceeded our expectations. We're looking at the number of people who sign up on our website, the number of website visits, number of sessions, and we'll continue to track it. But so far, everything has exceeded our expectations and the engagement with the materials has been fantastic.

Thank you. At this time, I would like to turn the call back to Mike Weiss for closing comments.

Great. Thank you, operator. And thanks again, everyone, for joining us. '25 was a very strong year for us. '26, we expect to be even stronger, including a number of very exciting catalysts, including the top line data from our ENHANCE trial, some preliminary data from Azer-cel and then perhaps the biggest one of all at the end of the year or early next year, pivotal data from the subcutaneous BRIUMVI program. To our TG employees, thank you always for your dedication to those living with MS. To the health care providers, individuals with MS and their families. Thank you for your trust. And to our long-term shareholders, thank you for recognizing the potential of what we are building here at TG. We're just getting started. Have a great day.