Q3 2025 TG Therapeutics Inc Earnings Call

greetings and welcome to the TG Therapeutics third quarter earnings, call in 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 Jena 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 wise, our chairman and chief executive officer

Adam Waldman, our chief commercial officer and shun power, our Chief Financial Officer.

Following our Safe Harbor statement, Michael will begin with an overview of our recent corporate developments.

Atom 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 meeting 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, RI for relapsing MS, continues to outperform. It exemplifies what happens when innovation meets execution.

We've always believed brownie, had a best-in-class profile and we've built what we believe is the best-in-class team around it.

What great people tend to work out pretty well in most businesses, and it seems to be working out pretty well for us, too.

We're equally committed to continuing to innovate to improve outcomes for those living with MS.

That's what's driving, the 2 pivot studies, we launched last quarter.

The first enhance.

Explores in a randomized cohort whether we can consolidate the Bonnevie day 1 and day 15 doses into a single day. 1 infusion while maintaining bioequivalent exposure,

Making treatment easier for patients and more efficient for centers.

In response from sites, patience 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 3 subcutaneous bubble toxin map study, which I would like to call a true subQ product.

Short push auto injector compatible, and designed for self-administration.

We're testing 2, 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 Topline pivotal data in late 26th or early 27th and if positive setting the stage for a potential approval,

And launched in 28.

We view subcutaneous iBot as a major opportunity that can nearly double the total addressable market for Bonnevie. If approved, it would make TG the only company offering both Ivy and self-administered CD20 options. We believe this provides us with a unique competitive advantage.

Subcut with acts may also open up new opportunities for us. For example, we continue to explore the potential of Ron vnmg and have treated a small number of patients with encouraging results.

Beyond our allergen, a carti 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; some look tempting.

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 is now authorized another 100 million dollar program, giving us flexibility to keep doing what makes sense.

Operationally we can continue to be profitable and growing and expect that Trend to continue.

Barring any 1-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 Wollman, our chief commercial officer to write a detailed debris on be launched 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 BMV.

Us net sales for BMV and Q3 total approximately 153 million, extending our track record of strong sequential and year-over-year growth.

Realm's performance. Once again, exceeded both our internal targets.

And the Street's expectations, 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 bring these 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 basic across academic centers and Community neurology practices.

Some patients choose the aicc.

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 CD 20s embi,

Value proposition is stronger than ever a convenient twice yearly. 1-hour infusion. Backed by 6 years of data, showing consistent, efficacy durable safety and proven real world performance.

At the 2025 action, conference date of further validated bmb's, long-term benefits and captured significant attention at the uh, across the MS community.

Results from the open label extension of the ultimate 1 and 2 trials. Showed that after 6 years of continuous treatment nearly 90% of patients, remain free from disability progression.

with an annualized relapse rate and a 6 year of treatment of just 0.012

Equivalent to 1 relapse. Every 83 years of patient treatment.

The safety profile remains stable with no new safety signals identified, reaffirming Bambi's long-term tolerability and consistency.

Complimenting. These clinical findings. There was real world data from the enable observational study which demonstrated that brammies advocacy and infusion tolerability are translating into meaningful measurable outcomes for people living with Ms in everyday practice.

Together these data strengthen these different differentiated positions 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 are across all settings from large academic centers to community practices. And the VA system where brami Remains the preferred anti-cd20 therapy.

Another key driver of our ongoing success has been the Strategic expansion of our commercial field organization.

As outlined in our launch plan, we have methodically grown the team over the last 2 years to align with the market opportunity.

Ensuring the right reach capabilities and expertise.

As adoption of Brand B continues to build, we are maintaining the discipline and the precision that defines TG's commercial approach.

This strategy is 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.

Many our strategic growth. Q3 also marked the First full quarter of our national television campaign supported by expanded. Digital streaming and social media initiatives.

These efforts are designed to work together to drive awareness, engagement, and patient activation, hopefully sparking meaningful conversations between patients and their healthcare providers about treatment options.

Early indicators that these efforts are working are encouraging branded search activity, website, traffic and quality website, visits, and overall brand, a patient brand awareness.

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 us, Bambi net revenue guidance.

From 570 to 575 million.

To now approximately 585 million for the full year 2025.

This updated guided guidance, reflects favorable demand Trends and consistent execution by our commercial team.

Looking beyond 2025, we remain highly confident in bream's long-term potential.

With a growing prescriber base expanding patient engagement, a proven commercial infrastructure and continued investment in our product life cycle. We Believe Bombi is on track to become a multi-billion dollar brand in RMS,

In summary in 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 your end and Beyond

TG.

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 strengths, with total revenue reaching $161.7 million, an increase of 93% compared to Q3 2024.

And 15% over Q2, 25.

Product Revenue totaled to 159.3 million driven primarily by 152.9 million in US Bri on the net sales.

Starting to outline our total operating expenses, defined as R&D and SG&A, excluding non-cash compensation. Those are $86.6 million in the third quarter and approximately $239 million for the nine months ended September 30th.

While the quarter 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 Bondi, as well as higher sgna, spend to support the continued expansion of the Bondi 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 dollars,

Following this activity, we ended the third quarter with approximately 178 million in cash cash equivalents and investment securities.

We believe the strong Capital position enables us to continue executing on our long 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 the 3.9 million or 2 cents 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, an evaluation 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 can conclude 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 teaching.

We delivered, strong commercial performance continue 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,

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And our first question will come from Tara brofft with TD Cowen.

Better than expected growth, like the DTC efforts and the enhanced data. Um, thanks so much.

Thanks for the question. Adam, you want to talk to that 1?

Sure, uh, number of factors and Tara, I think that the growth in in that we uh assumed in Q4 is is actually quite good um, 14% quarter over quarter, uh, in the in, in the third year here. I think that's that's a pretty good. Uh, that's a pretty good growth rate. Um, and you know, the, the, the guidance is based on a number of factors. Um,

Probably most uh, is patient retention at this point and better than expected patient retention that is helping us. Uh, you know, see demand growth. Um, but as I mentioned field, expansion is also helping us. Um, and hopefully, those media investments will will start to see. We'll start to see some demand increases as we go forward here, too.

Okay, great. Thanks.

Thank you.

And our next question comes from Brian Chang with JP Morgan.

Hey guys, thanks for taking up questions this morning. Um, just curious if you're starting to see additional demand coming from the permanent J code that's in place in April. I have a quick follow-up. Thank you.

Uh, Adam.

I think I think maybe you have the wrong product. Um we've had a j code for for several years. At this point.

And then, when you think about the expansion of your fuel operation, um, where is the focus of expansion specifically. Uh, as we turn into a fourth quarter and into new into next year, um, and how you measuring um, the the return here.

You're on a roll to keep going.

So sorry. So, so the the question was expansion of the, the field force, is that what you're getting at?

Yeah, the expansion of the Field Force. How, how are we thinking about the focus here? Um, as you think about fourth quarter, and into next year, um, where where is the focus? Um, where are you expanding specifically.

Sure. Yeah, I mean we're, we're we're seeing growth across all segments, uh, but, you know, we're we're focused on on, you know, continue to drive the hospital, uh, business. Um, you know, in Q3 we saw Hospital demand growth continued to outpace actually the Private Practice setting. Um, and and the addition of our new sales reps is is certainly expanded our reach. Um, and we believe that's having a a positive impact on the growth that we're seeing, uh, we continue to add new prescribers and new accounts on a on a very consistent basis. Um, and so we think all that is is having an impact. And, and uh, we

I think, as I mentioned in the, in the, uh, prepared remarks here, I think that's, uh, uh, certainly, uh, contributing to the growth that we're seeing.

Thanks guys.

Thank you, Brian.

And moving on to Korean Johnson with Goldman Sachs.

Good morning, you mentioned on the prepared remarks that the subcutaneous product could double the market opportunity. For Bond vnms. Maybe you could just provide some color on the factors that are underpinning that estimate. Uh, thank you.

Yeah, I'll I'll lead off. Thanks for the question. I'll lead off Adam and uh, you can certainly Jump Right In. Um, but for just using some real simple math is how we're getting there. So right now we we think that uh, the subq portion of the market is about 35 closer to 40% now and and growing. Uh, so at that level, that would almost double the uh the market opportunity for us again and if that sub 2 continues to grow as a percentage of the new start. So this is

Just to take 1 Step. This is based on Dynamic share. So not total share, but Dynamic share. Uh, so Dynamic share basis, subq self-administered subq is approximately 35 closer, probably to 40% uh, at this point potentially growing, you know, 3 years 2 and a half years or so, before it will be

On the market, 3 years, whatever it is give or take. Uh, 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.

Awesome. Thank you.

I've never been perfect in anything but thank you, Adam.

To Michael Dior with evercore isi.

Hey guys, thanks so much for taking my questions, and congrats on the continued progress. Uh, a few for me: any notable...

Inventory Channel Dynamics to note in 3 Q as well as gross to net changes. And uh also any color

That you care to offer on the competitive dynamics versus the current at-home subcutaneous competitor, which seems to be growing and has a follow-up.

And I think those both probably fall directly on on you. Yeah, yeah. The first part, Michael. Thanks for the question. Uh, no inventory changes or, or or growth in that changes in the quarter, uh, gross in that still within the range that we've we've provided. Um, 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 subcutaneous competitor, which seems to be growing?

Yeah, as Mike mentioned the sub Q uh that's in the market today does does appear to be growing. Uh, they had a good quarter, um, and you know, that that segment of the market um, is overall has been growing, um, over the last few years. Um, you know, probably faster on the IV Market, but, you know, it seems to have settled right here about 6,535 IV to subq, um, you know, in the future, you know, it's hard to hard to predict, you know, how that that will change.

But certainly, with more sub key products in the market, it's possible. You could see continued growth uh, in the sub Q section.

Um, our segment of the market. Um, but today, it looks like, you know, it, it things have it's pretty much settled out in 6535640. Uh, IBD. Subq. It's not, it's, it's, it's not stagnant. It can, it can go up and down a little bit, um, between quarters. But that's generally where it, where it has been and has settled out over the last 12 months, 12 to 18 months or so.

Very helpful. And and my last 1 is just uh, uh, on BMV subq any

updates to when we could possibly see initial PK or exposure data from from Phase 1.

Uh, yeah. So the, uh, the hope is that we'll be able to get that presented, uh, sometime in the, uh,

First, half of next year? Yeah, I think we're targeting the first half of things. As you recall, I've been saying for a while that the team's been sort of overwhelmed getting these studies up and running. They haven't really sat down to do the presentation yet, but I think they're now preparing for that. So I think we'll hopefully see something in the first half of next year.

Great. Thanks so much.

And again, that is Star 1. If you'd like to ask a question,

And moving on to Emily, bodnar with HC, Wayne Wright.

Hi, good morning. Um, 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 New York Forum, collaboration things.

Um, broke up a little bit for me in the middle of that question. But Sean sounds like, if you heard it, it's, uh,

For you, yep.

Yep, I heard it. Um, okay, thanks Emily. So, um, the the accounting for um, xus sales has been consistent since we entered into the deal, uh, with with nxp, um, when we sell products through to them, uh, that's recorded to, uh, product Revenue. Um, and then, of course, uh, royalties show up on the, uh, license Mouse and we'll see you line.

All right, thanks.

And we'll go next to prakar Agra wall with Cantor Fitzgerald.

Hi. Um, thank you for taking my questions, and congrats on another strong quarter. Uh, so maybe firstly, any initial thoughts on, um, 2026 trends? What could be deposited as a negative that we should be keeping an eye out for? And then secondly, I think Mike, you talked about, um, in the introductory remarks, uh, that, um, about deals that looked tempting. Can you talk about what were the reasons not to pursue these transactions? Was it price or something else? And, um, even if you decide to do BD, any uh, details on what stage, therapeutic area, or size of the deal would make sense? Thank you so much.

Sure. Um Adam you want to talk to the first person in terms of any thoughts on uh, on 26, positives or negatives. You can Envision today

Now represent a a larger and increasingly large part of our business. So the rate at which, uh, patients continue to come back at eighteen weeks, 487296 and and out, uh, will be important as I mentioned, that that continues to look very strong, uh, right now and continues to drive the, the growth that we're seeing, um, better than expected. Obviously, we're going to continue to Monitor and see how, um, our direct to Consumer efforts has, uh, an effect and impact on, um, you know, overall, you know, patient conversions and and onto treatment. And, and whether that's continuing to work, uh, like I said, in our, my prepared remarks, um, the indic key indicators at this point are very encouraging, uh, but we'll continue to see how that, uh, plays out in 2026 as well.

Thanks Adam. Uh, and in terms of deals look, we've we've been quite

Candid in that we've been, you know, looking to increase our uh, our portfolio looking for opportunities. I think we've seen every, you know, every announced deal that you think is within reason of of something that we'd be interested in. We, we've obviously evaluated and looked at extensively, um, I think for us, you know, we have a high high standard for for Roi, we have, you know, we we have a revenue, we're using our money, we're making Investments, you know, we've got a pretty high hurdle to to get over the hump. Uh, it's all about risk, reward.

And potential Roi as we see. And as we calculate it. So I think, you know, we've got a lot of, you know, good things in the portfolio already. Uh like I said, we're looking to expand but we're we're not.

Have any, uh, desperation to do so. So we have a lot of flexibility to to pick and choose what we want to do, uh, and how we want to do it, and make sure it makes sense. So, uh, you know, for us, it's all about, uh, Roi and risk reward. And I think the ones that we passed on, just didn't meet the threshold. Uh,

As far as we see it, but like I said, in the prepared remarks, we we continue to look for opportunities. And if we do something uh, you know, we'll we'll be sure that, you know, we believe in it. And uh and in any event we're we're always looking to manage our our risk versus the reward. It's always a very important uh, concept for us.

And moving on to William Wood with B. Riley Securities.

Hi, thank you for taking our questions. It was a really nice quarter. I have one question and one follow-up. I was just curious if you could provide a little bit more clarification on.

How when and and maybe expectations for uh fiscal year 2026 uh guidance on maybe not guidance per se but expectations on where you sort of see the revenues and and trying to really understand, um, you mentioned that a lot of this was a lot of your growth was uh sort of pegged to maintenance. And maybe if you could just speak to what you're seeing on sort of Maintenance drop offs or or switches away from from BMI, uh, and then I have a follow-up.

Sure, thanks. Uh, Adam, want to go ahead?

Sure not to uh, we're not going to get specific here on on uh 2026 uh guidance uh quite yet. But uh, you know, patient persistence remains above expectations and my comment was that, you know, that's an increasingly bigger and bigger will be coming. Increasingly bigger part of our business going forward. Obviously we can we continue to expect new patient growth. Um we continue to expect you know uh market share gains. And and um you know as as we continue to

Expand our Field Force and and with the DTC efforts that we're having. So those things work together in driving growth over over the long term. And, you know, I think, uh, uh, you know, the DTC Investments, as I said, you know, remains to be seen, uh, we're encouraged by what we're we're seeing so far. We're looking to optimize the investment and, and, uh, you know, really refine.

Are targeting and making sure that we're getting the right message to the right patient. Um and it's something that we want to, you know, continue to lean into uh, we'll be strategic about it. We'll be thoughtful about it. Uh, but we think it can help um, meaningfully, and into the future? Um, it remains to be seen. But, of course, uh, we we think so far what we're seeing is encouraging.

Uh, and then also, if you know, if there's anything specifically from, uh, the Bambi MG data that shows potential outside of MS, in autoimmune.

Yeah, thanks for that, William. I actually haven't had a chance to, uh, review the SLA 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. Um, but, uh, in terms of MG, uh, yeah, I mean CD20 is, you know, have applicability across multiple indications. Uh, we think MG is one of them. We've seen, uh,

We've certainly seen the the CD 19 data. Uh we wouldn't expect to see too many differences between uh I see the 19 CD 20 in terms of its ability to perform in a certain indication. So we think that mg is is is interesting. Uh, We've treated uh, you know, a handful of patients with some coverage in results. So I think there's there's something there, we're still tiptoeing around it for the moment but uh but if we dive in we'll certainly let you know. And again now that that's part of our, you know, same risk reward ROI analysis we're doing um in terms of how we want to invest our money so uh but yeah we we do think that mg is is is potentially interesting for us still. And uh we'll keep everyone posted on that if we do, uh, move forward.

Awesome, thank you. Uh we'll hop back in the queue and congratulations on the quarter.

Thank you.

And we'll go next to Chacha Yang with Jeffries.

Hi. This is Chacha on for Roger song. Uh, thanks for taking our question. I was hoping that you can give some color on how you expect the simplified dosing regimen for Bonnevie 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 mean I'll jump in

And save Adam from this 1. It's a, I, I don't know that there's an easy way to put numbers on top of it. I think this is this 1 doesn't have a clearly different, uh, addressable Market. Uh, so this is within our current adjustable Market. Uh, we do think that it's, um, it's a remark research that we've done that people are, uh, attracted to this and interested, and we think the enrollment, uh,

uh, the rapidity of the enrollment is also a clue that people are excited about this, uh, this potential update to the dosing schedule. Uh, but I think it's more challenging to put numbers to it. Like we what we're able to do, for the subq, which again is a uh, really a separate tab.

Adam, is there anything you want to add on top of that?

No, just other than reiterating that there's there. There seems to be, uh, you know, customer excitement about. Um,

The simplified regimen, and, um, we've heard this consistently from customers.

Thank you.

Thank you.

Let us now conclude our question and answer session. I would like to turn the floor back over to Michael Weiss for closing comments.

Thank you. Uh and thanks everyone again for joining us today. As we look ahead to the remainder of 2025, our priorities are clear to continue to grow on these sales.

Execute on our sub q and enhance phase, 3, trials Drive enrollment into our Azure sell program and position TG for long-term leadership in Ms and Beyond.

Our progress to date, I believe speaks volumes to the value bomb. Be delivered 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 HPS and people living with MS who continue to place their trust in Bonnevie and TG.

Thanks again for joining us. Everyone 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.