TG Therapeutics, Inc.TGTXNASDAQ
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Operator: Greetings, and welcome to the TG Therapeutics' Third Quarter Earnings Call and Webcast. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Jenna Bosco, Chief Communications Officer. Please go ahead.
Jenna Bosco: Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' Third 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 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 would 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 the 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 website at www.tgtherapeutics.com. With that, I'll turn the call over to Mike Weiss, our CEO. Mike?
Michael Weiss: Thank you, Jenna, and good morning, everyone. I'm pleased to report that TG delivered another strong quarter. Our flagship product, BRIUMVI for relapsing MS continues to outperform, exemplifying what happens when innovation meets execution. We've always believed BRIUMVI had a best-in-class profile, and we've built what we believe is the best-in-class team around it. That combination, great product, great people tends to work out pretty well in most businesses, and it seems to be working out pretty well for us, too. We're equally committed to continuing to innovate to improve outcomes for those living with MS. That's what's driving the 2 pivotal studies we launched last quarter. The first, ENHANCE, explores in a randomized cohort whether we can consolidate the BRIUMVI day 1 and day 15 doses into a single day 1 infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. The response from sites and patients has been tremendous, so much so that we've already completed enrollment. If all goes as planned, we should have data by the middle of next year and potentially a launch of this new simplified dosing schedule in 2027. The second is our Phase III subcutaneous ublituximab study, what I'd like to call a true subcu product, short push, auto-injector compatible and designed for self-administration. We're testing two dosing schedules, once every other month and once quarterly. Enrollment is going quite well, and we believe we're on track to finish enrollment in the first half of next year, deliver top line pivotal data in late '26 or early '27 and if positive, setting the stage for potential approval and launch in '28. We view subcutaneous ublituximab as a major opportunity that can nearly double the total addressable market for BRIUMVI. And if approved, it would make TG the only company offering both IV and self-administered CD20 options, we believe providing us with a unique competitive advantage. Subcu ublituximab may also open up new opportunities for us. For example, we continue to explore the potential of BRIUMVI in MG and have treated a small number of patients with encouraging results. Beyond BRIUMVI, we're developing azer-cel, our allogeneic CAR T therapy for individuals with progressive MS. It's still early, but for people living with progressive MS, this type of therapy could be life-changing. Looking across our pipeline, I can envision the possibility of meaningful new launches in '27, '28 and '29, each with the potential to drive continued growth into the next decade. While we innovate, we also remain financially disciplined. We've seen a lot of deals in the market lately. Some look tempting, but we've chosen to stay patient and true to our principles. And when we can't deploy capital better inside the business, we return it to shareholders. During the quarter, we completed our initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50. The Board has now authorized another $100 million program, giving us flexibility to keep doing what makes sense. Operationally, we continue to be profitable and growing and expect that trend to continue, barring any onetime business development moves that might change the picture temporarily, but strengthen it in the long term. In closing, Q3 was another quarter of strong execution and meaningful progress. We're delivering on our commercial goals, advancing our development programs and maintaining financial discipline, all while keeping patients at the center of everything we do. Now I'll hand the call over to Adam Waldman, our Chief Commercial Officer, to provide a detailed BRIUMVI launch update. Adam, go ahead.
Adam Waldman: Thank you, Mike, and good morning, everyone. I'm excited to share our third quarter commercial performance. As Mike mentioned, TG continues to execute exceptionally well across both our clinical and commercial fronts. And that progress is clearly reflected in another strong quarter for BRIUMVI. U.S. net sales for BRIUMVI in Q3 totaled approximately $153 million, extending our track record of strong sequential and year-over-year growth. BRIUMVI’s performance once again exceeded both our internal targets and the Street's expectation, underscoring the depth and consistency of demand we continue to see across the marketplace. We continue to see favorable dynamics across key commercial indicators. Demand remains strong, supported by sustained physician engagement and increasing patient awareness. Persistence and repeat prescribing both exceeded expectations, reinforcing our confidence in BRIUMVI’s clinical profile and the positive real-world experiences being reported by physicians and patients. We also continue to add new prescribers and accounts, broadening our base across academic centers and community neurology practices. We believe the anti-CD20 class will continue to expand as more physicians and patients choose the efficacy, safety and convenience of this treatment approach. The CD20 class now represents nearly $10 billion in annual U.S. MS sales and yet approximately half of all patients remain on other types of disease-modifying therapies, underscoring the significant opportunity that still exists for CD20s and BRIUMVI. The BRIUMVI value proposition is stronger than ever, a convenient twice yearly 1-hour infusion backed by 6 years of data showing consistent efficacy, durable safety and proven real-world performance. At the 2025 ACTRIMS Conference, data further validated BRIUMVI's long-term benefits and captured significant attention across the MS community. Results from the open-label extension of the ULTIMATE I and II trials showed that after 6 years of continuous treatment, nearly 90% of patients remain free from disability progression with an annualized relapse rate in the 6th year of treatment of just 0.012, equivalent to 1 relapse every 83 years of patient treatment. The safety profile remains stable with no new safety signals identified, reaffirming BRIUMVI's long-term tolerability and consistency. Complementing these clinical findings, there was real-world data from the ENABLE observational study, which demonstrated that BRIUMVI's efficacy and infusion tolerability are translating into meaningful measurable outcomes for people living with MS in everyday practice. Together, these data strengthen BRIUMVI's differentiated position as a therapy that we believe combines best-in-class efficacy, a proven safety record and unmatched infusion convenience. This powerful combination continues to resonate with healthcare providers across all settings from large academic centers to community practices and the VA system, where BRIUMVI remains the preferred anti-CD20 therapy. Another key driver of our ongoing success has been the strategic expansion of our commercial field organization. As outlined in our launch plan, we have methodically grown the team over the last 2 years to align with the market opportunity, ensuring the right reach, capabilities and expertise as adoption of BRIUMVI continues to build, while maintaining the discipline and the precision that defines TG's commercial approach. This strategy has proven highly effective, expanding our reach and helping us drive continued growth. We will continue to expand selectively as opportunities arise, maintaining a balanced focus on coverage, productivity and operational efficiency. We believe our approach have resulted in one of the most capable and experienced commercial teams in the MS industry, a team that executes with professionalism, consistency and a clear commitment to educating both patients and providers. Complementing our strategic growth, Q3 also marked the first full quarter of our national television campaign, supported by expanded digital streaming and social media initiatives. These efforts are designed to work together to drive awareness, engagement and patient activation, hopefully sparking meaningful conversations between patients and their healthcare providers about treatment options. Early indicators that these efforts are working are encouraging. Branded search activity, website traffic and quality website visits and overall brand -- a patient brand awareness are all elevated relative to pre-campaign baselines. And as we move into Q4, we plan to grow and optimize this investment to continue to build awareness and support long-term growth. Looking ahead, we remain confident in our trajectory. Based on the strong year-to-date performance, continued new patient growth and positive persistence trends, we are again raising our full year 2025 U.S. BRIUMVI net revenue guidance from $570 million to $575 million to now approximately $585 million for the full year 2025. This updated guidance reflects favorable demand trends and consistent execution by our commercial team. Looking beyond 2025, we remain highly confident in BRIUMVI’s long-term potential. With a growing prescriber base, expanding patient engagement, a proven commercial infrastructure and continued investment in our product life cycle, we believe BRIUMVI is on track to become a multibillion-dollar brand in RMS. In summary, Q3 was another strong quarter of execution, consistent performance and continued strategic progress. We're proud of what the team has accomplished this year and look forward to carrying that momentum into year-end and beyond. I want to thank our team for their ongoing dedication and professionalism. Your commitment continues to drive meaningful results for people living with MS and for TG. With that, I'll turn it over to Sean to walk through the financials.
Sean Power: Thank you, Adam, and good morning, everyone. Earlier this morning, we released our detailed third quarter 2025 financial results via press release, which is available on the Investors and Media section of our website. Let's begin with a closer look at our revenue performance. Our third quarter results reflect sustained commercial strength with total revenue reaching $161.7 million, an increase of 93% compared to Q3 '24 and 15% over Q2 '25. Product revenue totaled $159.3 million, driven primarily by $152.9 million in U.S. BRIUMVI net sales. Turning to expenses. Our total operating expenses, defined as R&D and SG&A, excluding noncash compensation, totaled approximately $86.6 million in the third quarter and approximately $239 million for the 9 months ended September 30. While the quarterly figure is up compared to the second quarter of '25, which came in at approximately $71 million, we remain on track to meet our full year OpEx guidance of approximately $300 million to $320 million. The quarter-over-quarter increase in OpEx was primarily driven by continued investment in R&D for subcutaneous BRIUMVI as well as higher SG&A spend to support the continued expansion of the BRIUMVI commercial footprint. On the balance sheet side of things, as Mike mentioned, we completed our initial share repurchase program. During the third quarter, we repurchased approximately $78 million of shares at an average price of approximately $28. Following this activity, we ended the third quarter with approximately $178 million in cash, cash equivalents and investment securities. 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. On the bottom line, we are pleased to report GAAP net income of $390.9 million or $2.43 per diluted share for the third quarter of 2025. This compares to $3.9 million or $0.02 per diluted share in the same period last year. Our third quarter results include a nonrecurring income tax benefit of approximately $365 million, driven by the release of our deferred tax asset valuation allowance. For reference, a valuation allowance is recorded against deferred tax assets when it is more likely than not that those assets will not be realized. Given our track record of profitability, projected operating income and positive outlook, we concluded that a release of the valuation allowance was appropriate as of September 30, 2025. While this release impacts reported GAAP net income and earnings per share, it does not affect our cash position or our day-to-day operating performance. This represents our sixth consecutive quarter of profitability, driven by BRIUMVI revenue growth and disciplined expense management. In summary, the third quarter was a meaningful step forward for TG. We delivered strong commercial performance, continued to invest in long-term growth opportunities and achieved our sixth consecutive quarter of profitability. With that, I will now turn the call over to the conference operator to begin the Q&A.
Operator: [Operator Instructions] And our first question will come from Tara Bancroft with TD Cowen.
Tara Bancroft: So my question is regarding the guidance. So this updated figure, it implies just a slight slowing of sequential growth in this Q4 versus what we've seen in prior Q4 reports in previous years. So I'm curious to get your thoughts on what kind of headwinds that you're expecting this quarter compared to prior years and maybe also a discussion of which tailwinds from here that can support maybe better-than-expected growth like the DTC efforts, the ENHANCE data, et cetera?
Michael Weiss: Thanks for the question. Adam, do you want to tackle that one?
Adam Waldman: Sure. A number of factors in Tara. I think the growth that we assumed in Q4 is actually quite good, 14% quarter-over-quarter in the third year here. I think that's a pretty good growth rate. And the guidance is based on a number of factors. Probably most is patient retention at this point and better-than-expected patient retention that is helping us see demand growth. But as I mentioned, field expansion is also helping us. And hopefully, those media investments will start to see some demand increases as we go forward here, too.
Operator: Our next question comes from Brian Cheng with JPMorgan.
Lut Ming Cheng: Just curious if you're starting to see additional demand coming from the permanent J-code that's in place in April? And then I have a quick follow-up.
Sean Power: Adam?
Adam Waldman: I think maybe you have the wrong product. We've had a J-code for several years at this point.
Lut Ming Cheng: And then when you think about the expansion of your field operation, where is the focus of expansion specifically as we turn into fourth quarter and into next year? And how are you measuring the return here?
Michael Weiss: Adam, you're on a roll, keep going.
Adam Waldman: Sorry. So the question was expansion of the field force. Is that what you're getting at?
Lut Ming Cheng: Yes, the expansion of the field force. How are we thinking about the focus here as you think about fourth quarter and into next year? Where is the focus? Where are you expanding specifically?
Adam Waldman: Sure. Yes. I mean we're seeing growth across all segments, but we're focused on continuing to drive the hospital business. In Q3, we saw hospital demand growth continue to outpace actually the private practice setting. And the addition of our new sales reps has certainly expanded our reach, and we believe that's having a positive impact on the growth that we're seeing. We continue to add new prescribers and new accounts on a very consistent basis. And so we think all that is having an impact. And we think, as I mentioned in the prepared remarks here, I think that's certainly contributing to the growth that we're seeing.
Operator: And moving on to Corinne Johnson with Goldman Sachs.
Corinne Jenkins: You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for BRIUMVI and MS. Maybe if you could just provide some color on the factors that are underpinning that estimate.
Michael Weiss: Yes, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. But Corinne, just using some real simple math is how we're getting there. So right now, we think that the subcu portion of the market is about 35% closer to 40% now and growing. So at that level, that would almost double the market opportunity for us again. And if that subcu continues to grow as a percentage of the new starts, so this is -- just to take one step ahead, this is based on dynamic share. So not total share, but dynamic share. So on a dynamic share basis, subcu -- self-administered subcu is approximately 35% closer probably to 40% at this point, potentially growing 3 years, 2.5 years or so before we'll be on the market for 3 years, whatever it is, give or take. So we think there's a chance that it will continue to grow. Obviously, 50% of new starts, that would double the opportunity. So we're somewhere approximately in that range. That's how we're getting to that number. Adam, anything to add on top?
Adam Waldman: No.
Operator: And we'll go next to Michael DiFiore with Evercore ISI.
Michael DiFiore: Congrats on the continued progress. A few for me. Any notable inventory channel dynamics to note in 3Q as well as gross to net changes? And also, any color that you care to offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? And I have a follow-up.
Michael Weiss: Adam, I think those both probably fall directly on you.
Adam Waldman: Yes. Yes. The first part, Michael, thanks for the question. No inventory changes or gross to net changes in the quarter. Gross to net is still within the range that we've provided. And then the second question was on subcu. Can you repeat the question on subcu?
Michael DiFiore: Just any color you could offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing.
Adam Waldman: Yes. As Mike mentioned, the subcu that's in the market today does appear to be growing. They had a good quarter. And that segment of the market is overall has been growing over the last few years, probably faster than the IV market. But it seems to have settled right here, about 65-35 IV to subcu. In the future, it's hard to predict how that will change. But certainly, with more subcu products in the market, it's possible you could see continued growth in the subcu section or segment of the market. But today, it looks like things have pretty much settled out in the 65-35, 60-40 IV to subcu. It's not stagnant. It can go up and down a little bit between quarters. But that's generally where it has been and has settled out over the last 12 months -- 12 to 18 months or so.
Michael DiFiore: Very helpful. And my last one is just on BRIUMVI subcu. Any update to when we could possibly see initial PK or exposure data from Phase I?
Michael Weiss: Yes. So the hope is that we'll be able to get that presented sometime in the first half of next year. Yes, I think we're targeting first half. I think the team, as you recall, I've been saying for a while, the team has been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet, but I think they're now preparing for that. So I think we'll hopefully see something in the first half of next year.
Operator: [Operator Instructions] And moving on to Emily Bodnar with H.C. Wainwright.
Emily Bodnar: I was wondering if you can walk us through a bit on the ex-U.S. sales of $6.4 million and just general accounting of the Neuraxpharm collaboration?
Michael Weiss: Broke up a little bit for me in the middle of that question. But Sean, it sounds like it's -- if you heard it, it's for you.
Sean Power: Yes, I heard it. Thanks, Emily. So the accounting for ex-U.S. sales has been consistent since we entered into the deal with NXP. When we sell products through to them, that's recorded to product revenue. And then, of course, royalties show up on the license milestone and royalty line.
Operator: And we'll go next to Prakhar Agrawal with Cantor Fitzgerald.
Prakhar Agrawal: Congrats on another strong quarter. So maybe firstly, any initial thoughts on 2026 trends? What could be the positives and negatives that we should be keeping an eye out for? And then secondly, I think, Mike, you talked about in the introductory remarks that about deals that look tempting. Can you talk about what were the reasons not to pursue these transactions? Was it the price or something else? And even if you decide to do BD, any details on what stage, therapeutic area or size of the deal would make sense?
Michael Weiss: Sure. Adam, do you want to tackle the first part in terms of any thoughts on '26, positives or negatives you can envision today?
Adam Waldman: Yes. I mean the things that we would be looking for, obviously, is continued growth in new patients. As I mentioned, people coming back now represent a larger and increasingly large part of our business. So the rate at which patients continue to come back at weeks 48, 72, 96 and out will be important. As I mentioned, that continues to look very strong right now and continues to drive the growth that we're seeing and better than expected. Obviously, we're going to continue to monitor and see how our direct-to-consumer efforts has an effect and impact on overall patient conversions on to treatment and whether that's continuing to work. Like I said in my prepared remarks, the key indicators at this point are very encouraging, but we'll continue to see how that plays out in 2026 as well.
Michael Weiss: Thanks, Adam. And in terms of deals, look, we've been quite candid in that we've been looking to increase our portfolio, looking for opportunities. I think we've seen every announced deal that you think is within reason of something that we'd be interested in, we've obviously evaluated and looked at extensively. I think for us, we have a high standard for ROI. We have revenue. We're using our money. We're making investments. We've got a pretty high hurdle to get over the hump. It's all about risk reward and potential ROI as we see it and as we calculate it. So I think we've got a lot of good things in the portfolio already. Like I said, we're looking to expand, but we're not -- we don't have any desperation to do so, so we have a lot of flexibility to pick and choose what we want to do and how we want to do it and make sure it makes sense. So for us, it's all about ROI and risk reward. And I think the ones that we passed on just didn't meet the threshold as far as we see it. But like I said in the prepared remarks, we continue to look for opportunities. And if we do something, we'll be sure that we believe in it. And in any event, we're always looking to manage our risk versus the reward. It's always a very important concept for us.
Operator: And moving on to William Wood with B. Riley Securities.
William Wood: Really nice quarter. Maybe one and one follow-up. I was just curious if you could provide a little bit more clarification on how, when and maybe expectations for fiscal year 2026 guidance on -- maybe not guidance per se, but expectations on where you sort of see the revenues and trying to really understand -- you mentioned that a lot of this was -- a lot of your growth was sort of pegged to maintenance. And maybe if you could just speak to what you're seeing on sort of maintenance drop-offs or switches away from BRIUMVI? And then I have a follow-up.
Michael Weiss: Sure. Thanks. Adam, go ahead.
Adam Waldman: Sure. Not to -- we're not going to get specific here on 2026 guidance quite yet, but patient persistence remains above expectations. And my comment was that, that's an increasingly bigger and will become an increasingly bigger part of our business going forward. Obviously, we continue to expect new patient growth. We continue to expect market share gains and as we continue to expand our field force and with the DTC efforts that we're having. So both things work together in driving growth over the long term. And I think the DTC investments, as I said, remains to be seen. We're encouraged by what we're seeing so far. We're looking to optimize the investment and really refine our targeting and making sure that we're getting the right message to the right patient. And it's something that we want to continue to lean into. We'll be strategic about it. We'll be thoughtful about it, but we think it can help meaningfully into the future. It remains to be seen. But of course, we think so far, what we're seeing is encouraging.
William Wood: Appreciate it. And then maybe just thinking about the Roche data in SLE from Gazyva this morning. I was curious how much read-through you may -- you sort of see in terms of that going to your BRIUMVI program? And then also if there's anything specifically from the BRIUMVI MG data that shows potential outside of MS in autoimmune?
Michael Weiss: Yes. Thanks for that, William. I actually haven't had a chance to review the SLE data very carefully this morning as we're preparing for this call. So I apologize for not being fully briefed on that at the moment. But in terms of MG, yes, I mean, CD20s have applicability across multiple indications. We think MG is one of them. We've certainly seen the CD19 data. We wouldn't expect to see too many differences between CD19 and CD20 in terms of its ability to perform in a certain indication. So we think that MG is interesting. We've treated a handful of patients with some encouraging results. So I think there's something there. We're still tiptoeing around it for the moment. But if we dive in, we'll certainly let you know. And again, now that's part of our same risk-reward ROI analysis we're doing in terms of how we want to invest our money. So -- but yes, we do think that MG is potentially interesting for us still, and we'll keep everyone posted on that if we do move forward.
Operator: And we'll go next to Cha Cha Yang with Jefferies.
Cha Cha Yang: This is Cha Cha on for Roger Song. I was hoping that you can give some color on how you expect the simplified dosing regimen for BRIUMVI to expand the market share. Do you have any numbers that you can put on that like you did for the subcutaneous product?
Michael Weiss: Yes. I mean I'll jump in and save Adam from this one. I don't know that there's an easy way to put numbers on top of it. I think this is -- this one doesn't have a clearly different addressable market. So this is within our current addressable market. We do think that it's through market research that we've done that people are attracted to this and interested. And we think the enrollment -- the rapidity of the enrollment is also a clue that people are excited about this potential update to the dosing schedule. But I think it's more challenging to put numbers to it like we're able to do for the subcu, which again is really a separate TAM. Adam, anything you want to add on top of that?
Adam Waldman: No, just other than reiterating that there seems to be customer excitement about the simplified regimen, and we've heard this consistently from customers.
Operator: And this now concludes our question-and-answer session. I would like to turn the floor back over to Mike Weiss for closing comments.
Michael Weiss: Thank you, and thanks, everyone, again, for joining us today. As we look ahead to the remainder of 2025, our priorities are clear: continue to grow BRIUMVI sales, execute on our subcu and ENHANCE Phase III trials, drive enrollment into our azer-cel program and position TG for long-term leadership in MS and beyond. Our progress to date, I believe, speaks volumes to the value BRIUMVI delivers to patients, healthcare providers and MS centers alike and reflects the dedication of the entire TG team who wake up every day focused on one simple idea, helping those with MS live better lives. I want to thank the entire TG team for their hard work and dedication as well as the HCPs and people living with their MS who continue to place their trust in BRIUMVI and TG. Thanks again for joining us, everyone, and have a great day.
Operator: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.