NASDAQ:TGTX TG Therapeutics Q3 2025 Earnings Report $39.43 -0.05 (-0.13%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$39.55 +0.12 (+0.30%) As of 05/19/2026 06:57 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast TG Therapeutics EPS ResultsActual EPS$2.43Consensus EPS $0.21Beat/MissBeat by +$2.22One Year Ago EPS$0.02TG Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ATG Therapeutics Announcement DetailsQuarterQ3 2025Date11/3/2025TimeBefore Market OpensConference Call DateMonday, November 3, 2025Conference Call Time8:30AM ETUpcoming EarningsTG Therapeutics' Q2 2026 earnings is estimated for Monday, August 3, 2026, based on past reporting schedules, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by TG Therapeutics Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 3, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: TG reported strong Q3 commercial results with total revenue of $161.7 million and US BRIUMVI net sales of about $152.9 million, and raised full‑year 2025 US BRIUMVI guidance to approximately $585 million. Positive Sentiment: The ENHANCE pivotal study testing a simplified single‑day infusion completed enrollment quickly, with topline data expected mid‑2026 and a potential launch of the simplified dosing in 2027 if results are favorable. Positive Sentiment: Enrollment in the phase‑3 program for subcutaneous BRIUMVI is progressing on schedule, with pivotal readouts expected late 2026/early 2027 and the company estimating the subQ option could nearly double the total addressable market if approved. Neutral Sentiment: TG completed the initial $100 million buyback (repurchasing ~3.5M shares) and the board authorized a second $100 million program; GAAP net income of $390.9M included a non‑recurring ~$365M release of deferred tax valuation allowance, and cash & equivalents were ~ $178M at quarter end. Negative Sentiment: Operating expenses rose (Q3 OPEX ex‑stock comp ~ $86.6M) due to R&D for subQ BRIUMVI and SG&A expansion, so near‑term performance depends on continued commercial execution and successful trial readouts for the pipeline programs. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallTG Therapeutics Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings and welcome to the TG Therapeutics third-quarter earnings call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 BoscoChief Communications Officer at TG Therapeutics00:00:30Thank 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, Michael 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 product. Jenna BoscoChief Communications Officer at TG Therapeutics00:01:26Please 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. Mike WeissChairman and CEO at TG Therapeutics00:02:04Thank 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 two pivotal studies we launched last quarter. The first, ENHANCE, explores in a randomized cohort whether we can consolidate the BRIUMVI day one and day 15 doses into a single day one infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. Mike WeissChairman and CEO at TG Therapeutics00:03:08The 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 three 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 2026 or early 2027, and if positive, setting the stage for potential approval and launch in 2028. We view subcutaneous ublituximab as a major opportunity that could nearly double the total addressable market for BRIUMVI. Mike WeissChairman and CEO at TG Therapeutics00:04:10If 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 2027, 2028, and 2029, 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. Mike WeissChairman and CEO at TG Therapeutics00:05:10Some look tempting, but we've chosen to stay patient and true to our principles. 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 one-time 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. Mike WeissChairman and CEO at TG Therapeutics00:06:08Now, I'll hand the call over to Adam Waldman, our Chief Commercial Officer, to provide a detailed BRIUMVI launch update. Adam, go ahead. Adam WaldmanChief Commercial Officer at TG Therapeutics00:06:17Thank 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. 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:07:14We 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, one-hour infusion backed by six 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:08:09Results from the open-label extension of the ULTIMATE I and II trials show that after six years of continuous treatment, nearly 90% of patients remain free from disability progression, with an annualized relapse rate in the six-year treatment of just 0.012, equivalent to one 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:09:09This 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 two 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:10:03We believe our approach has 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 patient brand awareness are all elevated relative to pre-campaign baselines. 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:11:09Based 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-$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 lifecycle, we believe BRIUMVI is on track to become a multi-billion 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:12:16Your commitment continues to drive meaningful results for people living with MS and for TG Therapeutics. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:12:28Thank 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 2024 and 15% over Q2 2025. 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 non-cash compensation, totaled approximately $86.6 million in the third quarter and approximately $239 million for the nine months ended September 30th. Sean PowerCFO at TG Therapeutics00:13:29While the quarterly figure is up compared to the second quarter of 2025, which came in at approximately $71 million, we remain on track to meet our full-year OpEx guidance of approximately $300 million-$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. Sean PowerCFO at TG Therapeutics00:14:39On 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 non-recurring 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 30th, 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. Sean PowerCFO at TG Therapeutics00:15:45This 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 Therapeutics. 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. Operator00:16:15Thank you. We will now be conducting a question-and-answer section. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question will come from Tara Bancroft with TD Cowen. Tara BancroftDirector and Senior Biotech Equity Research Analyst at TD Cowen00:16:50Hi, good morning. My question is regarding the guidance. This updated figure implies just a slight slowing of sequential growth in this Q4 versus what we've seen in prior Q4 reports in previous years. I'm curious to get your thoughts on what kind of headwinds you're expecting this quarter compared to prior years, and maybe also a discussion of which tailwinds from here can support maybe better than expected growth, like the DTC efforts, the enhanced data, et cetera. Thanks so much. Sean PowerCFO at TG Therapeutics00:17:24Thanks for the question. Adam, you want to tackle that one? Adam WaldmanChief Commercial Officer at TG Therapeutics00:17:28Sure. A number of factors, and Tara, I think that 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. 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. As I mentioned, field expansion is also helping us. Hopefully, those media investments will start to see some demand increases as we go forward here too. Tara BancroftDirector and Senior Biotech Equity Research Analyst at TD Cowen00:18:12Okay, great. Thanks. Adam WaldmanChief Commercial Officer at TG Therapeutics00:18:16Thank you. Operator00:18:19Our next question comes from Brian Chang with JPMorgan. Brian ChangVP and Equity Research Analyst at JPMorgan00:18:24Hey, guys. Thanks for taking our questions this morning. Just curious if you're starting to see additional demand coming from the permanent J code that's in place in April. We have a quick follow-up. Thank you. Sean PowerCFO at TG Therapeutics00:18:41Adam? Adam WaldmanChief Commercial Officer at TG Therapeutics00:18:43I think maybe you have the wrong product. We've had a J code for several years at this point. Brian ChangVP and Equity Research Analyst at JPMorgan00:18:50When 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? How are you measuring the return here? Sean PowerCFO at TG Therapeutics00:19:09Adam, you're on a roll. Keep going. Adam WaldmanChief Commercial Officer at TG Therapeutics00:19:13Sorry. The question was expansion of the field force? Is that what you're getting at? Brian ChangVP and Equity Research Analyst at JPMorgan00:19:20Yes, 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 WaldmanChief Commercial Officer at TG Therapeutics00:19:33Sure. Yeah. 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. 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. We think all that is having an impact. We think, as I mentioned in the prepared remarks here, I think that's certainly contributing to the growth that we're seeing. Brian ChangVP and Equity Research Analyst at JPMorgan00:20:19Thanks, guys. Sean PowerCFO at TG Therapeutics00:20:21Thank you, Brian. Operator00:20:24Moving on to Corinne Johnson with Goldman Sachs. Corinne JohnsonVP of Equity Research at Goldman Sachs00:20:29Good morning. You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for BRIUMVI in MS. Maybe you could just provide some color on the factors that are underpinning that estimate. Thank you. Mike WeissChairman and CEO at TG Therapeutics00:20:45Yeah, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. Corinne, just using some real simple math is how we're getting there. Right now, we think that the subcu portion of the market is about 35%, close to 40% now, and growing. At that level, that would almost double the market opportunity for us. Again, if that subcu continues to grow as a percentage of the new start, just to take one step back, this is based on dynamic share. Not total share, but dynamic share. On a dynamic share basis, self-administered subcu is approximately 35%, closer probably to 40%. At this point, potentially growing three years, two and a half years or so before we'll be on the market, three years, whatever it is, give or take. We think there's a chance that it'll continue to grow. Mike WeissChairman and CEO at TG Therapeutics00:21:46Obviously, at 50% of new starts, that would double the opportunity. We're somewhere approximately in that range. That's how we're getting to that number. Adam, anything to add on top? Adam WaldmanChief Commercial Officer at TG Therapeutics00:21:59No. Perfect. Corinne JohnsonVP of Equity Research at Goldman Sachs00:22:02Awesome. Thank you. Mike WeissChairman and CEO at TG Therapeutics00:22:04I've never been perfect in anything, but thank you, Adam. Operator00:22:11We'll go next to Michael DiFiore with Evercore ISI. Michael DiFioreManaging Director at Evercore ISI00:22:17Hey, guys. Thanks so much for taking my questions, and 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? Also, any color that you care to offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? I have a follow-up. Mike WeissChairman and CEO at TG Therapeutics00:22:42Adam, I think those both probably fall directly on you. Adam WaldmanChief Commercial Officer at TG Therapeutics00:22:46Yeah. Yeah, 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. The second question was on subcu. Can you repeat the question on subcu? Michael DiFioreManaging Director at Evercore ISI00:23:01Is there any color you could offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? Adam WaldmanChief Commercial Officer at TG Therapeutics00:23:12Yeah. As Mike mentioned, the subcu that's in the market today does appear to be growing. They had a good quarter. That segment of the market overall has been growing over the last few years, probably faster than the IV market. 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. 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. Today, it looks like things have pretty much settled out in 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 DiFioreManaging Director at Evercore ISI00:24:13Very helpful. My last one is just on BRIUMVI subcutaneous. Any updates to when we could possibly see initial PK or exposure data from phase I? Mike WeissChairman and CEO at TG Therapeutics00:24:27Yeah. The hope is that we'll be able to get that presented sometime in the first half of next year. Yeah, I think we're targeting first half. I think the team, as you recall, I've been saying for a while, the team's been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet. I think they're now preparing for that. I think we'll hopefully see something in the first half of next year. Michael DiFioreManaging Director at Evercore ISI00:24:54Great. Thanks so much. Operator00:24:59Again, that is star one if you'd like to ask a question. Moving on to Emily Bodnar with H.C. Wainwright. Emily BodnarBiotech Equity Research Analyst at H.C. Wainwright00:25:08Hi, good morning. 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. Thanks. Mike WeissChairman and CEO at TG Therapeutics00:25:23Broke up a little bit for me in the middle of that question. Sean, it sounds like if you heard it, it's for you. Sean PowerCFO at TG Therapeutics00:25:30Yep. Yep, I heard it. Thanks, Emily. The accounting for XUS sales has been consistent since we entered into the deal with Neuraxpharm. When we sell products through to them, that's recorded to product revenue. Then, of course, royalties show up on the license milestone and royalty line. Emily BodnarBiotech Equity Research Analyst at H.C. Wainwright00:25:59Got it. Thanks. Operator00:26:05We'll go next to Prakhar Agrawal with Cantor Fitzgerald. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:11Hi. Thank you for taking my questions, and congrats on another strong quarter. Maybe firstly, any initial thoughts on 2026 trends? What could be the positives and negatives that we should be keeping an eye out for? Secondly, I think Mikey talked about in the introductory remarks 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? If you decide to do BD, any details on what stage, therapeutic area, or size of the deal would make sense? Thank you so much. Sean PowerCFO at TG Therapeutics00:26:47Sure. Adam, you want to tackle the first part in terms of any thoughts on 2026, positives or negatives you can envision today? Adam WaldmanChief Commercial Officer at TG Therapeutics00:26:59Yeah. 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. Better than expected. Obviously, we're going to continue to monitor and see how our direct-to-consumer efforts have an effect and impact on overall patient conversions and onto 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. Sean PowerCFO at TG Therapeutics00:27:59Thanks, Adam. In terms of deals, 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. I think we've got a lot of good things in the portfolio already. Like I said, we're looking to expand, but we don't have any desperation to do so. Sean PowerCFO at TG Therapeutics00:28:52We 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. For us, it's all about ROI and risk-reward. I think the ones that we passed on just didn't meet the threshold as far as we see it. Like I said in the prepared remarks, we continue to look for opportunities. If we do something, we'll be sure that we believe in it. In any event, we're always looking to manage our risk versus the reward. That's always a very important concept for us. Operator00:29:35Moving on to William Wood with B. Riley Securities. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:29:41Hi. Thank you for taking our questions. 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. Maybe if you could just speak to what you're seeing on sort of maintenance drop-offs or switches away from BRIUMVI. Then I have a follow-up. Sean PowerCFO at TG Therapeutics00:30:30Sure. Thanks. Adam, you want to go ahead? Adam WaldmanChief Commercial Officer at TG Therapeutics00:30:35Sure. We're not going to get specific here on 2026 guidance quite yet. But patient persistence remains above expectations. 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. As we continue to expand our field force and with the DTC efforts that we're having, both things work together in driving growth over the long term. I think the DTC investments, as I said, remain 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. It's something that we want to continue to lean into. We'll be strategic about it. We'll be thoughtful about it. Adam WaldmanChief Commercial Officer at TG Therapeutics00:31:37We think it can help meaningfully into the future. It remains to be seen. Of course, we think so far what we're seeing is encouraging. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:31:48Got it. Appreciate it. Maybe just thinking about the Roche data in SLE from Gazyva this morning. I was curious how much read-through you sort of see in terms of that going to your BRIUMVI program. Also, if there's anything specifically from the BRIUMVI MG data that shows potential outside of MS in autoimmune? Sean PowerCFO at TG Therapeutics00:32:16Yeah. 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. I apologize for not being fully briefed on that at the moment. In terms of MG, yeah, 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 a CD19 and CD20 in terms of its ability to perform in a certain indication. We think that MG is interesting. We've treated a handful of patients with some encouraging results. I think there's something there. We're still tiptoeing around it for the moment. If we dive in, we'll certainly let you know. Again, that's part of our same risk-reward ROI analysis we're doing in terms of how we want to invest our money. Sean PowerCFO at TG Therapeutics00:33:17We do think that MG is potentially interesting for us still. We'll keep everyone posted on that if we do move forward. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:33:28Awesome. Thank you. We'll hop back into Q and congratulations on the quarter. Sean PowerCFO at TG Therapeutics00:33:33Thank you. Operator00:33:36We will go next to Cha Cha Yang with Jefferies. Cha Cha YangSenior Biotech Equity Research Associate at Jefferies00:33:41Hi, this is Cha Cha Yang for Roger Song. Thanks for taking our question. 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? Sean PowerCFO at TG Therapeutics00:33:57Yeah. I mean, I'll jump in and say that from this one. I don't know that there's an easy way to put numbers on top of it. I think 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. 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. I think it's more challenging to put numbers to it like we were able to do for the subcu, which again is really a separate tab. Adam, anything you want to add on top of that? Adam WaldmanChief Commercial Officer at TG Therapeutics00:34:45No. Just other than reiterating that there seems to be customer excitement about the simplified regimen. And we've heard this consistently from customers. Cha Cha YangSenior Biotech Equity Research Associate at Jefferies00:35:02Okay. Thank you. Sean PowerCFO at TG Therapeutics00:35:05Thank you. Operator00:35:07This now concludes our question and answer session. I would like to turn the floor back over to Mike Weiss for closing comments. Mike WeissChairman and CEO at TG Therapeutics00:35:16Thank you. 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 subcutaneous and enhanced phase three trials, drive enrollment into our azer-cel program, and position TG Therapeutics 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. It reflects the dedication of the entire TG Therapeutics 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 Therapeutics team for the hard work and dedication, as well as the HCPs and people living with MS who continue to place their trust in BRIUMVI and TG Therapeutics. Thanks again for joining us, everyone. Have a great day. Operator00:36:08Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.Read moreParticipantsExecutivesSean PowerCFOJenna BoscoChief Communications OfficerMike WeissChairman and CEOAdam WaldmanChief Commercial OfficerAnalystsCha Cha YangSenior Biotech Equity Research Associate at JefferiesWilliam WoodHealthcare Equity Research Analyst at B. Riley SecuritiesTara BancroftDirector and Senior Biotech Equity Research Analyst at TD CowenBrian ChangVP and Equity Research Analyst at JPMorganMichael DiFioreManaging Director at Evercore ISIEmily BodnarBiotech Equity Research Analyst at H.C. WainwrightCorinne JohnsonVP of Equity Research at Goldman SachsPrakhar AgrawalManaging Director at Cantor FitzgeraldPowered by Earnings DocumentsEarnings Release(8-K)Quarterly Report(10-Q) TG Therapeutics Earnings HeadlinesTG Therapeutics (NASDAQ:TGTX) Shares Pass Above 200-Day Moving Average - Here's What HappenedMay 19 at 3:47 AM | americanbankingnews.comTG Therapeutics' (NASDAQ:TGTX) Earnings Aren't As Good As They AppearMay 13, 2026 | finance.yahoo.comRead now. Do not delete. You’ve been warned.Three Nobel Prize Winners expose this once-in-a-generation wealth shift: “Don’t Say I Didn’t Warn You” Porter Stansberry exposes how the convergence of three immense forces is about to rewrite everything about the American way of life: how you work, save, invest… it’s all about to change. | Porter & Company (Ad)Why TG Therapeutics (TGTX) Is Up 27.4% After Raising 2026 Revenue Guidance On BRIUMVI StrengthMay 11, 2026 | finance.yahoo.comAssessing TG Therapeutics (TGTX) Valuation After Recent Share Price MomentumMay 10, 2026 | finance.yahoo.comTG Therapeutics Reports First Quarter 2026 Financial Results and Raises BRIUMVI Revenue GuidanceMay 6, 2026 | markets.businessinsider.comSee More TG Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like TG Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on TG Therapeutics and other key companies, straight to your email. Email Address About TG TherapeuticsTG Therapeutics (NASDAQ:TGTX) is a clinical‐stage biopharmaceutical company headquartered in New York City that specializes in developing targeted therapies for hematological malignancies and autoimmune diseases. The company’s research strategy focuses on the modulation of B-cell biology through novel antibody and small‐molecule agents. Since its founding in 2003, TG Therapeutics has built a diversified portfolio aimed at addressing unmet medical needs in oncology and immunology. In December 2022, TG Therapeutics achieved its first commercial milestone when ublituximab-xiiy (marketed as Briumvi® in collaboration with Biogen) received U.S. Food and Drug Administration approval for the treatment of relapsing forms of multiple sclerosis. Earlier, in February 2021, the company’s selective PI3Kδ inhibitor umbralisib (UKONIQ®) was granted accelerated approval by the FDA for relapsed marginal zone lymphoma and follicular lymphoma. These regulatory achievements underscore TG’s ability to advance candidates from discovery through critical review. The company’s pipeline extends beyond its approved therapies to include next‐generation anti-CD20 antibodies, such as TG-1701, and novel PI3K inhibitors designed to improve safety and efficacy profiles. Additional programs in clinical development target complementary pathways in B-cell malignancies and autoimmune disorders. TG Therapeutics conducts multi‐center trials across North America and Europe to evaluate these assets in a range of disease settings, with an emphasis on optimizing combination regimens and identifying patient subgroups most likely to benefit. Guided by a management team with deep experience in oncology drug development and regulatory affairs, TG Therapeutics leverages strategic partnerships, in‐house research capabilities and contract research organizations to accelerate its clinical programs. The company’s operations span discovery, translational research and late‐stage development, positioning it to address both rare and prevalent immune‐mediated diseases on a global scale.View TG Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Why Home Depot’s Sell-Off Could Become a Huge OpportunityBrady Corp Wires Up a Massive AI-Powered BreakoutDillard’s Posted a Huge Earnings Beat—So Why Did the Rally Fade?Why Applied Optoelectronics Stock May Be Near a Turning PointIs Everspin Technologies the Next AI Edge Breakout?Peloton Stock Gives Back Gains After Upbeat Earnings ReportDatavault Gains Traction: 5 Reasons to Sell Now Upcoming Earnings Analog Devices (5/20/2026)Intuit (5/20/2026)NVIDIA (5/20/2026)Lowe's Companies (5/20/2026)Medtronic (5/20/2026)Target (5/20/2026)TJX Companies (5/20/2026)NetEase (5/21/2026)Ross Stores (5/21/2026)Walmart (5/21/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Greetings and welcome to the TG Therapeutics third-quarter earnings call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 BoscoChief Communications Officer at TG Therapeutics00:00:30Thank 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, Michael 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 product. Jenna BoscoChief Communications Officer at TG Therapeutics00:01:26Please 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. Mike WeissChairman and CEO at TG Therapeutics00:02:04Thank 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 two pivotal studies we launched last quarter. The first, ENHANCE, explores in a randomized cohort whether we can consolidate the BRIUMVI day one and day 15 doses into a single day one infusion while maintaining bioequivalent exposure, making treatment easier for patients and more efficient for centers. Mike WeissChairman and CEO at TG Therapeutics00:03:08The 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 three 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 2026 or early 2027, and if positive, setting the stage for potential approval and launch in 2028. We view subcutaneous ublituximab as a major opportunity that could nearly double the total addressable market for BRIUMVI. Mike WeissChairman and CEO at TG Therapeutics00:04:10If 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 2027, 2028, and 2029, 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. Mike WeissChairman and CEO at TG Therapeutics00:05:10Some look tempting, but we've chosen to stay patient and true to our principles. 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 one-time 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. Mike WeissChairman and CEO at TG Therapeutics00:06:08Now, I'll hand the call over to Adam Waldman, our Chief Commercial Officer, to provide a detailed BRIUMVI launch update. Adam, go ahead. Adam WaldmanChief Commercial Officer at TG Therapeutics00:06:17Thank 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. 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:07:14We 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, one-hour infusion backed by six 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:08:09Results from the open-label extension of the ULTIMATE I and II trials show that after six years of continuous treatment, nearly 90% of patients remain free from disability progression, with an annualized relapse rate in the six-year treatment of just 0.012, equivalent to one 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:09:09This 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 two 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:10:03We believe our approach has 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 patient brand awareness are all elevated relative to pre-campaign baselines. 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:11:09Based 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-$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 lifecycle, we believe BRIUMVI is on track to become a multi-billion 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. Adam WaldmanChief Commercial Officer at TG Therapeutics00:12:16Your commitment continues to drive meaningful results for people living with MS and for TG Therapeutics. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:12:28Thank 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 2024 and 15% over Q2 2025. 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 non-cash compensation, totaled approximately $86.6 million in the third quarter and approximately $239 million for the nine months ended September 30th. Sean PowerCFO at TG Therapeutics00:13:29While the quarterly figure is up compared to the second quarter of 2025, which came in at approximately $71 million, we remain on track to meet our full-year OpEx guidance of approximately $300 million-$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. Sean PowerCFO at TG Therapeutics00:14:39On 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 non-recurring 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 30th, 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. Sean PowerCFO at TG Therapeutics00:15:45This 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 Therapeutics. 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. Operator00:16:15Thank you. We will now be conducting a question-and-answer section. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question will come from Tara Bancroft with TD Cowen. Tara BancroftDirector and Senior Biotech Equity Research Analyst at TD Cowen00:16:50Hi, good morning. My question is regarding the guidance. This updated figure implies just a slight slowing of sequential growth in this Q4 versus what we've seen in prior Q4 reports in previous years. I'm curious to get your thoughts on what kind of headwinds you're expecting this quarter compared to prior years, and maybe also a discussion of which tailwinds from here can support maybe better than expected growth, like the DTC efforts, the enhanced data, et cetera. Thanks so much. Sean PowerCFO at TG Therapeutics00:17:24Thanks for the question. Adam, you want to tackle that one? Adam WaldmanChief Commercial Officer at TG Therapeutics00:17:28Sure. A number of factors, and Tara, I think that 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. 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. As I mentioned, field expansion is also helping us. Hopefully, those media investments will start to see some demand increases as we go forward here too. Tara BancroftDirector and Senior Biotech Equity Research Analyst at TD Cowen00:18:12Okay, great. Thanks. Adam WaldmanChief Commercial Officer at TG Therapeutics00:18:16Thank you. Operator00:18:19Our next question comes from Brian Chang with JPMorgan. Brian ChangVP and Equity Research Analyst at JPMorgan00:18:24Hey, guys. Thanks for taking our questions this morning. Just curious if you're starting to see additional demand coming from the permanent J code that's in place in April. We have a quick follow-up. Thank you. Sean PowerCFO at TG Therapeutics00:18:41Adam? Adam WaldmanChief Commercial Officer at TG Therapeutics00:18:43I think maybe you have the wrong product. We've had a J code for several years at this point. Brian ChangVP and Equity Research Analyst at JPMorgan00:18:50When 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? How are you measuring the return here? Sean PowerCFO at TG Therapeutics00:19:09Adam, you're on a roll. Keep going. Adam WaldmanChief Commercial Officer at TG Therapeutics00:19:13Sorry. The question was expansion of the field force? Is that what you're getting at? Brian ChangVP and Equity Research Analyst at JPMorgan00:19:20Yes, 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 WaldmanChief Commercial Officer at TG Therapeutics00:19:33Sure. Yeah. 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. 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. We think all that is having an impact. We think, as I mentioned in the prepared remarks here, I think that's certainly contributing to the growth that we're seeing. Brian ChangVP and Equity Research Analyst at JPMorgan00:20:19Thanks, guys. Sean PowerCFO at TG Therapeutics00:20:21Thank you, Brian. Operator00:20:24Moving on to Corinne Johnson with Goldman Sachs. Corinne JohnsonVP of Equity Research at Goldman Sachs00:20:29Good morning. You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for BRIUMVI in MS. Maybe you could just provide some color on the factors that are underpinning that estimate. Thank you. Mike WeissChairman and CEO at TG Therapeutics00:20:45Yeah, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. Corinne, just using some real simple math is how we're getting there. Right now, we think that the subcu portion of the market is about 35%, close to 40% now, and growing. At that level, that would almost double the market opportunity for us. Again, if that subcu continues to grow as a percentage of the new start, just to take one step back, this is based on dynamic share. Not total share, but dynamic share. On a dynamic share basis, self-administered subcu is approximately 35%, closer probably to 40%. At this point, potentially growing three years, two and a half years or so before we'll be on the market, three years, whatever it is, give or take. We think there's a chance that it'll continue to grow. Mike WeissChairman and CEO at TG Therapeutics00:21:46Obviously, at 50% of new starts, that would double the opportunity. We're somewhere approximately in that range. That's how we're getting to that number. Adam, anything to add on top? Adam WaldmanChief Commercial Officer at TG Therapeutics00:21:59No. Perfect. Corinne JohnsonVP of Equity Research at Goldman Sachs00:22:02Awesome. Thank you. Mike WeissChairman and CEO at TG Therapeutics00:22:04I've never been perfect in anything, but thank you, Adam. Operator00:22:11We'll go next to Michael DiFiore with Evercore ISI. Michael DiFioreManaging Director at Evercore ISI00:22:17Hey, guys. Thanks so much for taking my questions, and 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? Also, any color that you care to offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? I have a follow-up. Mike WeissChairman and CEO at TG Therapeutics00:22:42Adam, I think those both probably fall directly on you. Adam WaldmanChief Commercial Officer at TG Therapeutics00:22:46Yeah. Yeah, 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. The second question was on subcu. Can you repeat the question on subcu? Michael DiFioreManaging Director at Evercore ISI00:23:01Is there any color you could offer on the competitive dynamics versus the current at-home subcu competitor, which seems to be growing? Adam WaldmanChief Commercial Officer at TG Therapeutics00:23:12Yeah. As Mike mentioned, the subcu that's in the market today does appear to be growing. They had a good quarter. That segment of the market overall has been growing over the last few years, probably faster than the IV market. 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. 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. Today, it looks like things have pretty much settled out in 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 DiFioreManaging Director at Evercore ISI00:24:13Very helpful. My last one is just on BRIUMVI subcutaneous. Any updates to when we could possibly see initial PK or exposure data from phase I? Mike WeissChairman and CEO at TG Therapeutics00:24:27Yeah. The hope is that we'll be able to get that presented sometime in the first half of next year. Yeah, I think we're targeting first half. I think the team, as you recall, I've been saying for a while, the team's been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet. I think they're now preparing for that. I think we'll hopefully see something in the first half of next year. Michael DiFioreManaging Director at Evercore ISI00:24:54Great. Thanks so much. Operator00:24:59Again, that is star one if you'd like to ask a question. Moving on to Emily Bodnar with H.C. Wainwright. Emily BodnarBiotech Equity Research Analyst at H.C. Wainwright00:25:08Hi, good morning. 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. Thanks. Mike WeissChairman and CEO at TG Therapeutics00:25:23Broke up a little bit for me in the middle of that question. Sean, it sounds like if you heard it, it's for you. Sean PowerCFO at TG Therapeutics00:25:30Yep. Yep, I heard it. Thanks, Emily. The accounting for XUS sales has been consistent since we entered into the deal with Neuraxpharm. When we sell products through to them, that's recorded to product revenue. Then, of course, royalties show up on the license milestone and royalty line. Emily BodnarBiotech Equity Research Analyst at H.C. Wainwright00:25:59Got it. Thanks. Operator00:26:05We'll go next to Prakhar Agrawal with Cantor Fitzgerald. Prakhar AgrawalManaging Director at Cantor Fitzgerald00:26:11Hi. Thank you for taking my questions, and congrats on another strong quarter. Maybe firstly, any initial thoughts on 2026 trends? What could be the positives and negatives that we should be keeping an eye out for? Secondly, I think Mikey talked about in the introductory remarks 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? If you decide to do BD, any details on what stage, therapeutic area, or size of the deal would make sense? Thank you so much. Sean PowerCFO at TG Therapeutics00:26:47Sure. Adam, you want to tackle the first part in terms of any thoughts on 2026, positives or negatives you can envision today? Adam WaldmanChief Commercial Officer at TG Therapeutics00:26:59Yeah. 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. Better than expected. Obviously, we're going to continue to monitor and see how our direct-to-consumer efforts have an effect and impact on overall patient conversions and onto 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. Sean PowerCFO at TG Therapeutics00:27:59Thanks, Adam. In terms of deals, 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. I think we've got a lot of good things in the portfolio already. Like I said, we're looking to expand, but we don't have any desperation to do so. Sean PowerCFO at TG Therapeutics00:28:52We 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. For us, it's all about ROI and risk-reward. I think the ones that we passed on just didn't meet the threshold as far as we see it. Like I said in the prepared remarks, we continue to look for opportunities. If we do something, we'll be sure that we believe in it. In any event, we're always looking to manage our risk versus the reward. That's always a very important concept for us. Operator00:29:35Moving on to William Wood with B. Riley Securities. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:29:41Hi. Thank you for taking our questions. 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. Maybe if you could just speak to what you're seeing on sort of maintenance drop-offs or switches away from BRIUMVI. Then I have a follow-up. Sean PowerCFO at TG Therapeutics00:30:30Sure. Thanks. Adam, you want to go ahead? Adam WaldmanChief Commercial Officer at TG Therapeutics00:30:35Sure. We're not going to get specific here on 2026 guidance quite yet. But patient persistence remains above expectations. 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. As we continue to expand our field force and with the DTC efforts that we're having, both things work together in driving growth over the long term. I think the DTC investments, as I said, remain 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. It's something that we want to continue to lean into. We'll be strategic about it. We'll be thoughtful about it. Adam WaldmanChief Commercial Officer at TG Therapeutics00:31:37We think it can help meaningfully into the future. It remains to be seen. Of course, we think so far what we're seeing is encouraging. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:31:48Got it. Appreciate it. Maybe just thinking about the Roche data in SLE from Gazyva this morning. I was curious how much read-through you sort of see in terms of that going to your BRIUMVI program. Also, if there's anything specifically from the BRIUMVI MG data that shows potential outside of MS in autoimmune? Sean PowerCFO at TG Therapeutics00:32:16Yeah. 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. I apologize for not being fully briefed on that at the moment. In terms of MG, yeah, 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 a CD19 and CD20 in terms of its ability to perform in a certain indication. We think that MG is interesting. We've treated a handful of patients with some encouraging results. I think there's something there. We're still tiptoeing around it for the moment. If we dive in, we'll certainly let you know. Again, that's part of our same risk-reward ROI analysis we're doing in terms of how we want to invest our money. Sean PowerCFO at TG Therapeutics00:33:17We do think that MG is potentially interesting for us still. We'll keep everyone posted on that if we do move forward. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:33:28Awesome. Thank you. We'll hop back into Q and congratulations on the quarter. Sean PowerCFO at TG Therapeutics00:33:33Thank you. Operator00:33:36We will go next to Cha Cha Yang with Jefferies. Cha Cha YangSenior Biotech Equity Research Associate at Jefferies00:33:41Hi, this is Cha Cha Yang for Roger Song. Thanks for taking our question. 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? Sean PowerCFO at TG Therapeutics00:33:57Yeah. I mean, I'll jump in and say that from this one. I don't know that there's an easy way to put numbers on top of it. I think 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. 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. I think it's more challenging to put numbers to it like we were able to do for the subcu, which again is really a separate tab. Adam, anything you want to add on top of that? Adam WaldmanChief Commercial Officer at TG Therapeutics00:34:45No. Just other than reiterating that there seems to be customer excitement about the simplified regimen. And we've heard this consistently from customers. Cha Cha YangSenior Biotech Equity Research Associate at Jefferies00:35:02Okay. Thank you. Sean PowerCFO at TG Therapeutics00:35:05Thank you. Operator00:35:07This now concludes our question and answer session. I would like to turn the floor back over to Mike Weiss for closing comments. Mike WeissChairman and CEO at TG Therapeutics00:35:16Thank you. 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 subcutaneous and enhanced phase three trials, drive enrollment into our azer-cel program, and position TG Therapeutics 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. It reflects the dedication of the entire TG Therapeutics 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 Therapeutics team for the hard work and dedication, as well as the HCPs and people living with MS who continue to place their trust in BRIUMVI and TG Therapeutics. Thanks again for joining us, everyone. Have a great day. Operator00:36:08Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.Read moreParticipantsExecutivesSean PowerCFOJenna BoscoChief Communications OfficerMike WeissChairman and CEOAdam WaldmanChief Commercial OfficerAnalystsCha Cha YangSenior Biotech Equity Research Associate at JefferiesWilliam WoodHealthcare Equity Research Analyst at B. Riley SecuritiesTara BancroftDirector and Senior Biotech Equity Research Analyst at TD CowenBrian ChangVP and Equity Research Analyst at JPMorganMichael DiFioreManaging Director at Evercore ISIEmily BodnarBiotech Equity Research Analyst at H.C. WainwrightCorinne JohnsonVP of Equity Research at Goldman SachsPrakhar AgrawalManaging Director at Cantor FitzgeraldPowered by