TG Therapeutics Q1 2025 Earnings Call Transcript

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May 5, 2025

There are 11 speakers on the call.

Operator

Greetings, and welcome to TG Therapeutics First Quarter Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Chief Communications Officer.

Operator

Thank you. You may begin.

Speaker 1

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter twenty twenty five financial results are Michael Weiss, our Chairman and Chief Executive Officer Adam Waldman, our Chief Commercialization Officer and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our recent corporate developments, Adam will share an update on our commercialization efforts, and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q and A session. Before we begin, I'd like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1

These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected milestones, revenue guidance, development plans and expectations for our marketed products. TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics operations include various risk factors that can be found in our SEC filings. In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward looking statements.

Speaker 1

This conference call is being recorded for audio rebroadcast on TG's website at www.tgtherapeutics.com, where it will be available for the next thirty days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

Speaker 2

Thanks, Jenna, and good morning, everybody, and thanks for joining us on today's call. It's a pleasure to be here with you and to broaden update on TG's continued progress both in the successful launch of BRYONVY and in building a company committed to improving the lives of those living with multiple sclerosis. I'm excited to share that we kicked off 2025 with another strong quarter performance underscoring the sustained momentum behind Reonvi. As you may have seen in the press release this morning, Reonvi U. Net sales reached nearly $120,000,000 in the first quarter, once again exceeding our expectations.

Speaker 2

This growth reflects both the increasing adoption by healthcare providers and a rising tide of patient interest and confidence in Breonvi. Over the past month, I spent a significant amount of time in the field meeting with prescribers and it's energizing to see firsthand how BRIONVI is becoming the go to anti CD20 therapy for many of them. But what's even more gratifying is hearing directly from people living with MS. At a recent MS walk, I spoke with two individuals who shared their experiences switching to Reumvi from another approved IV anti CD20 therapy. They both described how they previously felt unwell for days or more after each infusion, but not with Reonvi.

Speaker 2

Their stories echo findings from a recent paper in Frontiers in Immunology, which highlighted seven case reports of people with MS who switched to BREONVY from a prior anti CD20 due to issues like tolerability, disease activity, wearing off effects or incomplete B cell depletion. In each case, the unwanted effect either resolved or did not recur with BREONVY. These real world experiences support the idea that not all CD20s are the same and that switching within the class may make a difference. This point is reinforced by another recent publication in CNS drugs, which explores how structural and mechanistic differences among CD20 therapies may drive variations in efficacy and tolerability. Word-of-mouth within the MS community is powerful and we believe these success stories are helping to drive continued growth and enthusiasm.

Speaker 2

As I often say, the more people who start Breonvi, the more people will start Breonvi. And even in a highly competitive market, our team and Breonvi's unique profile are rising to the challenge. I couldn't be more proud of how our team has executed our multi phase launch strategy and the strong start we've made in 2025 as we pursue our long term goal of making VYOMVI the number one prescribed anti CD20 as measured by dynamic market share. In a moment, Adam Waldman, our Chief Commercialization Officer will walk you through the commercial performance in more detail as well as our investment priorities and updated guidance for Q2 and full year 2025. But first, I'd like to highlight our pipeline and efforts to enhance the BRYONVY experience.

Speaker 2

A core focus of our innovation strategy is simplifying the patient experience. Our ENHANCE clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results. We previously presented data from this study demonstrating the safety and tolerability of a thirty minute maintenance infusion as well as initiating BRYONVY treatment with a single full dose four fifty milligram infusion for patients switching from another CD20 who had low B cell counts. And most recently at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BRIONVY with a single six hundred milligram dose on day one, effectively eliminating the need for a day fifteen dose. Feedback on this streamlined approach has been very positive.

Speaker 2

We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BREONVY a true twice a year therapy from day one. We are now preparing to advance this regimen into its registration directed trial. Another exciting initiative is the development of a self administered subcu Breomni. While the vast majority of patients continue to prefer to receive their anti CD20 as an IV infusion, there is a growing minority who are now choosing a self administered subcutaneous option, of which there's only one available today. We see a clear opportunity to expand access and choice with a self administered subcu Reonvi.

Speaker 2

Our ongoing Phase one safety and bioequivalence study is showing promising results. The subcu injection appears to be well tolerated with bioavailability that appears to support every other month or even potentially quarterly dosing. We're pleased with the progress so far and on track to launch a pivotal trial this year. We also believe the subcu formulation may open new doors for us in new indications. One area that we are currently exploring is the potential for subcu BREONVY and myasthenia gravis and we're evaluating potential additional indications as well.

Speaker 2

Finally, on the pipeline front, we continue to be excited about azurecel, our allogeneic CD19 CAR T cell therapy. It's early days for CAR T's and autoimmune diseases, but we see great potential across multiple indications. We are excited to launch our Phase one for azurecel in progressive forms of MS, a segment of the MS population with limited treatment options and poor prognosis. In closing, 2025 is off to a very strong start. We're executing on our commercial strategy, advancing our clinical programs and expanding our manufacturing capacity to meet the growing demand.

Speaker 2

I want to thank the entire TG team for their dedication and hard work and for their commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS. And now I'll turn the call over to Adam Wohlman, our Chief Commercialization Officer. Adam, go ahead.

Speaker 3

Thanks, Mike, and good morning, everyone. I'm excited to share the details of another strong quarter of commercial execution, delivering meaningful growth and further validating our belief in the long term potential of BREOMBI in the RMS market. U. S. Net sales for BRIUMBI in the first quarter of twenty twenty five were approximately $119,700,000 exceeding our internal expectations and reflecting a strong start to the year with 137% year over year growth and 16% sequential quarter over quarter growth.

Speaker 3

Based on this performance and the strength of leading indicators, we are increasing our full year 2025 BRIONVI U. S. Net revenue guidance, which I will detail at the end of my remarks. We continue to see strength across our key performance drivers. The first three months of the year marked our highest months of total new patient enrollment since launch, a clear indication that demand continues to accelerate.

Speaker 3

This is despite the headwinds typically seen in the first quarter and an ongoing competitive product launch. Importantly, March was also our highest month ever for repeat prescribers with physicians coming back to prescribe Reumvir again, a strong signal of growing prescriber confidence and satisfaction. Further, saw continued strength in the hospital setting, which contributed approximately sixty percent of enrollments in March, The highest percent to date highlighting our deepening footprint among institutional accounts. With this continued growth for the first time repeat prescriptions have now surpassed new prescriptions. A key inflection point in BREONVY's lifecycle, demonstrating strong persistence trends at week 24 and week 48.

Speaker 3

While we remain in the competitive marketplace, BREONVY continues to stand out. Our five year data, consistent real world safety and efficacy profiles, combined with our unique one hour, twice a year infusion remain highly compelling to both physicians and patients. Importantly, we're seeing both an expansion of the CD20 market overall and continued dynamic market share gains for BRIONVI in the anti CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switch patients. Additionally, from my point of view, the field team has executed with excellence. We've deepened our reach among high volume infusion centers, community neurologists and leading academic institutions, and we continue to receive positive feedback on our team from our customers.

Speaker 3

As we look ahead to the remainder of 2025, we are focused on several key growth drivers. First, continuing to accelerate uptake among community neurologists, academic and broader practice types. Second, we will be launching our first ever direct to patient BREONVY television commercial campaign, including full digital surround sound strategy to educate, inspire and activate eligible patients to seek out BRIONB treatment. Third, our teams will continue to build and leverage a real world evidence to support BRIONB's position as a differentiated and trusted anti CD20 option. And fourth, we will start preparing for lifecycle innovations, including our subcutaneous formulation, which we believe represents a significant long term growth opportunity.

Speaker 3

In summary, we are off to a strong start in 2025. Our Q1 results reflect growing demand, increasing prescriber confidence, growing patient awareness and broad commercial execution. Looking ahead, we are optimistic about the continued growth and potential of BREONVY. As I mentioned, based on current trends in both new patient accumulations and persistence, we are raising our full year 2025 U. S.

Speaker 3

Net revenue guidance from $525,000,000 which we highlighted at JPMorgan in January to $560,000,000 for the full year 2025. Additionally, Q2 was already off to a strong start with April being another record month for enrollments into our hub. And while we are still early into the quarter, we're currently targeting $135,000,000 for the second quarter. With a robust foundation in place, multiple catalysts on the horizon and a highly differentiated product, we believe Briohnke is well positioned to become a market leading therapy in RMS. I want to thank our commercial team for their tireless commitment and drive.

Speaker 3

Your work is making a meaningful impact on the lives of people living with MS. We're proud of the momentum we've built and are more excited than ever about what lies ahead. And with that, I'll turn the call over to Sean to walk through our financials. Sean?

Speaker 4

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed first quarter twenty twenty five financial results in a press release, which is available on the Investors and Media section of our website. I'd like to start today with a quick overview of our first quarter revenue, something Adam and Mike both already touched on briefly. We're very pleased to report U. S.

Speaker 4

Net product revenue of $119,700,000 for the first quarter of twenty twenty five. This reflects 137% growth compared to the same period last year and a 16% increase over the fourth quarter of twenty twenty four. This continued momentum underscores the strong demand that we're seeing for BRIONVI. Turning to operating expenses, excluding non cash items. Our total OpEx for the quarter, which includes both R and D and SG and A expenses came in at approximately $82,000,000 for the quarter.

Speaker 4

That's tracking slightly ahead of our full year guidance of approximately $300,000,000 This increase during the quarter was primarily driven by about $20,000,000 in manufacturing investments for subcutaneous BREONVY. We expect these costs charged to R and D to fluctuate from quarter to quarter. But importantly, we remain confident in our full year OpEx guidance of approximately $300,000,000 On the bottom line, thanks to the continued strong performance of BREONVY, we reported GAAP net income of approximately $5,000,000 or $03 per diluted share for the quarter ended 03/31/2025. And finally, a quick note on our balance sheet. We closed the quarter with $276,000,000 in cash, cash equivalents and investment securities.

Speaker 4

We believe this puts us in a strong financial position to continue executing our commercial strategy, advancing our pipeline and supporting our operations for the foreseeable future. Before concluding, I'd like to offer some initial perspectives on the recent discussions regarding potential tariffs. As you may know, BRIONVI is currently manufactured in South Korea. Given our relatively low cost of goods, we do not anticipate that the currently proposed tariffs will have a material impact on our gross margins or overall financial performance. Nonetheless, we are actively monitoring developments and evaluating all of our options.

Speaker 4

With that, I will now turn the call over to the conference operator to begin the Q and A.

Operator

Thank you. The floor is now open for questions. Today's first question is coming from Tara Bancroft of TD Cowen. Please go ahead.

Speaker 5

Hi, good morning and thanks for taking the question. So I was hoping maybe you could provide a little bit more color on competitive dynamics, especially with OCREVUS de novo and like what are you seeing with competitive new patient share there? I ask because Roche had a small but meaningful miss this quarter. So I'm wondering if what you're hearing, if anything, on preferred uptake of BREONVY in new patients versus other treatments? Thanks so much.

Speaker 2

Adam, you want to go ahead and take that one?

Speaker 3

Yes, sure. I think as I mentioned in my comments, Tara, that we saw the highest three months ever in patient enrollments. We saw a really strong month in April. So we believe we're continuing to drive market share gains. We set back at JPMorgan, we think we're getting about 25% of the IV segment.

Speaker 3

We assume that's up from there and we continue to see good traction in the marketplace. So really encouraged by what we're seeing. On the question on ZENOVO, from what we can tell, we've seen zero impact on BREONVY.

Speaker 5

Great. Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. The next question is coming from Michael Dufoury of Evercore ISI. Please go ahead.

Speaker 6

Hey guys, hope all is well. Thanks for taking my question. Just two for me. Just any update on gross to net trends this quarter, figuring how the Part D redesign may have affected this and any comments on how this may affect gross to net for the balance of the year? And also with regards to gross margin, when can we expect you to fully deplete, I guess, the prelaunch reserves in gross margin?

Speaker 6

And perhaps when could we expect maybe kind of a decrease there? Thank you.

Speaker 2

Adam, I'll take the GTN and maybe Sean, the gross margin.

Speaker 3

Sure. On the gross to net question, no material change in gross to net in the quarter. Part D redesign is not really relevant for our drug, which is a Part B drug.

Speaker 2

Sean?

Speaker 4

Yes, sure. Thanks, Mike. So we're we fully depleted that pre commercial inventory reserve that you're speaking of. So the margins you're seeing this quarter and going forward should be the fully baked number and consistent quarter to quarter.

Speaker 2

Thanks. Thanks, Michael.

Operator

Thank you. The next question is coming from Roger Song of Jefferies. Please go ahead.

Speaker 7

Great. Congrats for the quarter and then thank you for taking our questions. So maybe the question related to the subcu of BREONVY, you said you will start pivotal this year. So just curious what's this current thinking about? How many doses you will move forward?

Speaker 7

And then when we will start to see the PK data second half? Thank you.

Speaker 2

Sure. Thanks, Roger. Yes, I mean, we're still leaning toward having two dosing regimens in there, so the every other month and the quarterly as part of the pivotal, we still got a little time to make a final decision, but that's definitely where we're leaning today. And in terms of PK data coming out probably later this year, we just haven't been focused and we continue to collect more data. So I think we're continuing to work on that study.

Speaker 2

It's going to lead us right into the trial, then we'll figure out when we present some of the data. But again, I think we're being super conservative in having two dosing regimens in the pivotal trial. If we do that and if we don't do that, it's because we're so confident in one or the other.

Speaker 7

Thank you.

Speaker 2

Thanks, Roger.

Operator

Thank you. The next question is coming from Mayank Mamtani of B. Riley Securities. Please go ahead.

Speaker 8

Yes, good morning. Thanks for taking my questions and congrats on the quarter. On the thirty minute infusion data that also we saw at ANN update, Mike, could you touch on the physician feedback there? And also, how might your data be tracking in depleting depleted and non depleted patients as you obviously try to understand the switch profile in ENHANCE and broadly about your Phase III trial scale and scope, if you could comment on that, that would be helpful.

Speaker 2

Sure. So with respect to the thirty minute infusion, the feedback has been positive. Actually, maybe, Adam, you've talked to a lot of folks about that as well. Do you want to touch on the thirty minute infusion? Any thoughts there?

Speaker 3

Yes, think there has been very positive feedback on the thirty minute infusion. Physicians think it's a convenience for their busy infusion centers. Patients think it's a much more convenient option. And the data so far is showing that it's well tolerated. So it's a very positive and physicians have encouraged us to continue to develop.

Speaker 2

Thanks, Adam. Yes, so in terms sorry, did I cut you off, Adam?

Speaker 8

No, no, ahead. Were going to comment on Phase three. And my question, the second part was actually around the R and D spend also, which seems like it's tracking higher. So yes, if you could factor in the Phase three comments there, if that would start this year, for example. And then also, as you kind of commented on the SG and A spend for second half given the DTC spend commitment, if you could comment on how you're thinking about profitability going forward?

Speaker 2

Yes. Mike, you've a lot in there. So I'll to take it in a few steps and you follow-up if you like. But the just in terms of the pivotal program, so I'll just be clear. There's two pivotal programs that we're planning.

Speaker 2

One is for the combined day one and day fifteen dose. That study again should simplify the onboarding of patients. We're looking at that six hundred milligram dose on day one and no day 15. And that study should start hopefully in the next one, two, three months the latest. So that's ongoing.

Speaker 2

Thirty minute infusion is probably something we're going to look at getting going later in the year or early next year. There's a little more logistics involved in that program than the six hundred milligram. In terms of the R and D spend that Sean mentioned, again, think the only delta is just the materials that we have to produce to make the subcu that hit the R and D line instead of the CMC manufacturing line. So I think in terms of our overall R and D spend, we're right on target to what we thought would be. And in terms of profitability, I'll let Sean discuss two things he could add.

Speaker 2

But I don't think we're highly focused on profitability this year. And I think in terms of the way we view the world, we're not using cash. We should be driving cash through the business. But I don't think we're prepared to start targeting profitability and earnings per share on an ongoing basis. I think we'll stick to revenue guidance for now and some OpEx guidance.

Speaker 2

But we do have plans to not use cash during the course of the year, that's for sure. Is there something else I missed in there, Mike? Had a few points.

Speaker 8

You did cover it all. Thank you, Mike. Lastly, have to ask a tariff question. How far along is your North Carolina plant in being able to produce commercial scale manufacturing? If you could just update on that.

Speaker 8

And thanks for taking all the questions.

Speaker 2

Yes, you got it. Yes, so moving manufacturing is not an easy task. And so I think we've said it will be several years before we'd be able to manufacture out of that North Carolina facility. So for the moment, I don't think it's a near term event. It will take several years and know the group is working on processes to get there, including potentially even starting out in Europe to perfect it while they're actually working on the facility here.

Speaker 2

So it's a long term process. It was never really meant that all occurred, as everyone may remember, before any of this tariff talk. It was not a design program for avoiding tariffs. It was a design program to have backup manufacturing. So we're working on it as quickly as we can.

Speaker 2

But again, as Sean mentioned, I don't think we feel that we're going to be impacted too much from many of the tariff stuff no matter what the final outcome is.

Speaker 8

Understood. Thank you, guys.

Operator

Thank you. The next question is coming from Eric Joseph of JPMorgan. Please go ahead.

Speaker 9

Hi, guys. This is Ron on for Eric. Congrats on the quarter. And just wanted to ask, I believe you previously cited expectations of about 20% product adherence between biannual infusions. Do you have a sense of that metric in Q1 and any anticipated fluctuations going forward?

Speaker 10

Thanks.

Speaker 2

Sure. Adam, you want to grab that one?

Speaker 3

Yes, sure. Can you just clarify the question? I didn't hear the first you said did you what was the percentage you said?

Speaker 9

70% adherence between biannual infusions.

Speaker 3

Yes. Don't remember saying that. But what I would say is the persistence trends, as I said in my remarks, remain very much very positive. Persistence remains strong and above our expectations.

Speaker 9

Okay. Thank you, guys.

Operator

Thank you. The next question is coming from Prakhar Adderall of Cantor Fitzgerald. Please go ahead.

Speaker 10

Hi, thank you for taking my questions and congrats on the quarter. So firstly on subcu BREONVY, when is the Phase pivotal trial expected to start? I think previously you had mentioned targeting mid year twenty twenty five as the timeline. Is that still on track? And secondly, on a question on Breomby outside of MS.

Speaker 10

What do you need to see for Breomby's profile in indications like myasthenia gravis to make the decision to invest further, especially given you have seen some interesting data from the CD19 drugs in this space, especially Amgen's?

Speaker 2

Yes. Thanks, Parker. So in terms of subcu, yes, still on track. As we said in the prepared remarks, still on track with the subcu timelines. And in terms of MG data, yes, I mean, we're definitely moving cautiously forward in that area.

Speaker 2

We've been speaking to lots of KOLs. We'll keep reviewing the data. We'll get a chance to see how the CD19 is received in the marketplace. So I think we're not prepared to go diving into the pool just yet, but we've got more than a toe in and we're continuing to evaluate that. I don't think it's one piece of information.

Speaker 2

I think there's an aggregate of information. And I don't think most of that information is necessarily related to our drug and the performance of our drug. I think it's more related to the marketplace and how things evolve. So we're going to stay on top of it. We're going to keep pushing forward at a moderate pace with an ability to accelerate in any moment if we feel that the time is right.

Speaker 10

Got it. And maybe just one last question. What percentage of Bionvy patients right now are switches from Ocrevus? And is this a trend that you're seeing more of an infection this year and if so why is that the case?

Speaker 2

Adam, you want go ahead?

Speaker 3

Yeah. We haven't I wouldn't say we've seen material changes in the percent of switches. We still see a healthy amount of switches from OCREVUS. And that trend has stayed consistent since launch. So no material change and I'm sorry, I don't remember the second part of the question.

Operator

Thank you. At this time, I would like to turn the floor back over to Mr. Weiss for closing comments.

Speaker 2

Great. Thank you, operator and everyone. Thanks for joining us. As you can see, we're off to a very strong start in 2025 and we're looking forward to keeping that momentum positive going forward into the rest of the year. We've got a number of key objectives that we're still looking to achieve and discussed on today's call.

Speaker 2

Of course, meeting our revenue targets that we've set, commencing pivotal trials for the simplified starting dose for IV Guaramvi and for subcu BREONVY as well as executing on our Phase I trials for BREONVY in patients with myasthenia gravis and for azacel in patients with progressive forms of MS. Beyond that, we continue to evaluate opportunities to extend our portfolio of product opportunities across autoimmune and auto inflammatory diseases and we'll continue our share buyback program. In closing, I want to extend a heartfelt thank you to all the individuals living with MS and healthcare providers who place their trust in TG and Breomvy. It's your courage and inspires everything that we do here at TG. So we really do appreciate it.

Speaker 2

And again, thanks everyone for joining us today. Have a nice day.

Operator

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.

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