TG Therapeutics, Inc.

Greetings, 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.

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? Thank you, Jenna, and good morning, everyone. I'm pleased to report that TG delivered another strong quarter. Our flagship product, Reumvi, for relapsing MS, continues to outperform, exemplifying what happens when innovation meets execution. We've always believed Brown V had a best in class profile, and we 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 BrionV 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. 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 three subcutaneous lubletuximab study, what I'd like to call a true sub-Q 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 lubotuximab as a major opportunity that can nearly double the total addressable market for BrionV. And if approved, it would make TG the only company offering both IV and and self-administered CD20 options, we believe providing us with a unique competitive advantage. Subcute libituximab may also open up new opportunities for us. For example, we continue to explore the potential of BrionV and MG and have treated a small number of patients with encouraging results. Beyond BrionV, we're developing Azercel, 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 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. Now, I'll hand the call over to Adam Wallman, our Chief Commercial Officer, to provide a detailed Briambi launch update. Adam, go ahead.

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 Briambi. U.S. net sales for Briambi in Q3 totaled approximately 153 million, extending our track record of strong sequential and year-over-year growth. BrionB'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 BrionB'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 USMS 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 BRIOMB. The BRIOMB 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 Actrum Conference, data further validated BRIOMB's long-term benefits and captured significant attention across the MS community. Results from the open-label extension of the ultimate one and two 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 sixth year of treatment of just .012, equivalent to one relapse every 83 years of patient treatment. The safety profile remains stable, with no new safety signals identified, reaffirming Brionbee's long-term tolerability and consistency. Complementing these clinical findings, there was real-world data from the ENABLE observational study, which demonstrated that Brionbee's efficacy and infusion tolerability are translating into meaningful, measurable outcomes for people living with MS in everyday practice. Together, these data strengthened Brionbee'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 Brumby 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 BrailleBeat 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 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. 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. Breon B net revenue guidance from $570 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 Brownbee'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 Breon B 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. 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.

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. pre-MV 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. 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 to $320 million. The quarter-over-quarter increase in OPEX was primarily driven by continued investment in R&D for subcutaneous BRIOMB, as well as higher SG&A spend to support the continued expansion of the BRIOMB 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 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 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 Brandy 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.

Thank you. We will now be conducting a question and answer section. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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 start keys. And our first question will come from Tara Bancroft with TD Cowen.

Hi, good morning. 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 enhanced data, etc.? ? Thanks so much.

Thanks for the question. Adam, you want to tackle that one?

Sure. A number of factors, and 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, you know, 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, you know, see demand growth. But as I mentioned, field expansion is also helping us. And hopefully those media investments, we'll start to see some demand increases as we go forward here, too.

Okay, great. Thanks.

Thank you. Our next question comes from Brian Chang with J.P. Morgan.

Hey, 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. And then we'll have a quick follow-up. Thank you.

Adam?

I think maybe you have the wrong product. We've had a J code for several years at this point.

And then when you think about the expansion of your fuel 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?

Adam, you're on a roll.

Keep going. Sorry. So the question was expansion of the fuel force? Is that what you're getting at?

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?

Sure. Yeah, I mean, we're seeing growth across all segments, but, you know, we're focused on, you know, continuing to drive the hospital business. You know, in Q3, we saw hospital demand growth continue to outpace, actually, the private practice settings. 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.

Thanks, guys. Thank you, Brian.

And moving on to Corrine Johnson with Goldman Sachs. Good morning.

You mentioned in the prepared remarks that the subcutaneous products could double the market opportunity for Breon VNMS. Maybe if you could just provide some color on the factors that are underpinning that estimate. Thank you.

Yeah, I'll lead off. Thanks for the question. I'll lead off, Adam, and you can certainly jump right in. But just using some real simple math is how we're getting there. So right now, we think that the sub-Q portion of the market is about 35, close to 40% now and growing. So at that level, that would almost double the market opportunity for us again. And if that SubQ continues to grow as a percentage of the new start. So this is, just to take one step out, this is based on dynamic share. So not total share, but dynamic share. So on dynamic share basis, SubQ, self-administered SubQ 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. so we think there's a chance that they'll continue to grow. Obviously, at 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? No. Perfect. Thank you. I've never been perfect in anything, but thank you, Adam.

And we'll go next to Michael DeFiore with Evercore ISI.

Hey, 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 growth to net changes? And also, any color that you care to offer on the competitive dynamics versus the current at-home sub-Q competitor, which seems to be growing? And I have a follow-up.

Adam, I think those both probably fall directly on you.

Yeah. Yeah, the first part, Michael, thanks for the question. No inventory changes or gross net changes in the quarter. Gross net's still within the range that we've provided. And then the second question was on sub-Q. Can you repeat the question on sub-Q?

Is there any code you could offer on the competitive dynamics versus the current at-home sub-Q competitor, which seems to be growing?

Yeah, as Mike mentioned, the sub-Q that's in the market today does appear to be growing. They had a good quarter, and, you know, that segment of the market is overall has been growing over the last few years, you know, probably faster than the IV market. But, you know, it seems to have settled right here, about 6535 IV to sub-Q. In the future, it's hard to predict how that will change, but certainly with more sub-Q products in the market, it's possible you could see continued growth in the sub-Q section or segment of the market. But today, it looks like things have pretty much settled out in 65-35, 60-40. IBD sub-Q, 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.

Very helpful. And my last one is just on Breon V sub Q. Any updates to when we could possibly see initial PK or exposure data from Phase I?

Yeah. So 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 getting these studies up and running they haven't really sat down to do the presentation yet but I think they're they're now preparing for that so I think we'll hopefully see something the first half of next year great thanks so much and again that is star one if you'd like to ask a question

And moving on to Emily Bodnar with HC Wingwright.

Hi, good morning. I was wondering if you could walk us through a bit on the XUS sales of $6.4 million and just general accounting of the direct farm collaboration.

Thanks. Broke up a little bit for me in the middle of that question, but Sean, it sounds like if you heard it, it's for you.

Yep. Yep, I heard it. Thanks, Emily. So the accounting for XUS 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 licensed milestone and royalty line.

Thank you.

and we'll go next to Prakhar Agarwal with Cantor Fitzgerald.

Hi, thank you for taking my questions and 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 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? Thank you so much.

Sure. Adam, you want to talk in the first part in terms of any thoughts on 26 positives or negatives you can envision today? Okay.

Yeah, 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 has 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.

Thanks, Adam. And 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 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, 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. 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.

And moving on to William Wood with B Reilly Securities.

All right, thank you for taking our questions, and really nice quarter. Maybe one and one follow-up. I was just curious if you could provide a little bit more clarification on 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, from Briambi and then I have a follow-up. Sure.

Thanks. Adam, go ahead.

Sure. 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 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, you know, remains to be seen. We're encouraged by what we're seeing so far. We're looking to optimize the investment and, you know, 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, you know, 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.

Got it. Appreciate it. And then maybe just thinking about the Roche data in SLE from Gaziva this morning, I was curious how much read-through you sort of see in terms of that going to your Briambi program. And then also, you know, if there's anything specifically from the Briambi MG data that shows potential outside of MS in autoimmune.

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, 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. 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, that's part of our same risk-reward ROI analysis we're doing. in terms of how we want to invest our money. But, yeah, we do think that MG is potentially interesting for us still, and we'll keep everyone posted on that if we do move forward.

Awesome. Thank you. We'll hop back into the queue, and congratulations on the quarter.

Thank you. And we'll go next to Cha-Cha Yang with Jefferies.

Hi, this is Cha-Cha on 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 Breon V to expand the market share. Do you have any numbers that you can put on that like you did for the subcutaneous product?

Yeah, 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 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 were able to do for the sub-Q, which, again, is really a separate TAM. Adam, anything you want to add on top of that?

No, just other than reiterating that there seems to be customer excitement about the simplified regimen, and we've heard this consistently from customers.

Okay, thank you. Thank you. And this now concludes our question and answer session. I would like to turn the floor back over to Mike Wise for closing comments.

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 BrionV cells, execute on our sub-Q and enhanced phase 3 trials, drive enrollment into our Azor cell program, and position TG for long-term leadership in MS and beyond. Our progress to date, I believe, speaks volumes to the value BrionV delivers to patients, healthcare providers, and MS centers alike. and it 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 MS who continue to place their trust in Brionvi and TG. Thanks again for joining us, everyone, and have a great day.

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.