TG Therapeutics Q1 2025 Earnings Report

TG Therapeutics EPS Results

• Actual EPS: $0.03
• Consensus EPS: $0.19
• Beat/Miss: Missed by -$0.16
• One Year Ago EPS: -$0.07

TG Therapeutics Revenue Results

• Actual Revenue: $120.86 million
• Expected Revenue: $117.07 million
• Beat/Miss: Beat by +$3.79 million
• YoY Revenue Growth: +90.40%

TG Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 5/7/2025
• Time: Before Market Opens
• Conference Call Date: Monday, May 5, 2025
• Conference Call Time: 8:30AM ET

TG 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.

TG Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• Q1 Breonvi net sales reached $119.7M, surpassing expectations with 137% year-over-year growth and a 16% sequential increase.
• The company raised its 2025 U.S. net revenue guidance from $525M to $560M and forecasts $135M in Q2 sales, citing record new enrollments and repeat prescriber trends.
• ENHANCE trial data support a streamlined 600 mg single-dose regimen on day one—eliminating the day-15 infusion—with plans to initiate a registration-directed pivotal study imminently.
• A self-administered subcutaneous Breonvi formulation showed favorable safety and bioequivalence in Phase I, with pivotal trials on track this year to support every-other-month or quarterly dosing.
• Early pipeline progress includes launching a Phase I allogeneic CD19 CAR T therapy (azurecel) in progressive MS, while North Carolina manufacturing capacity remains years away from commercial scale.

Presentation

[Operator]

Greetings and welcome to TG Therapeutics' Q1 conference call and webcast. At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Chief Communications Officer. Thank you. You may begin.

[Jenna Bosco, Chief Communications Officer at TG Therapeutics]

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the Q1 2025 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&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. 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 product.

[Jenna Bosco, Chief Communications Officer at TG Therapeutics]

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. 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 30 days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

[Michael Weiss, CEO at TG Therapeutics]

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 provide an update on TG's continued progress, both in the successful launch of BRIUMVI 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 of performance, underscoring the sustained momentum behind BRIUMVI. As you may have seen in the press release this morning, BRIUMVI U.S. sales reached nearly $120 million in the Q1, once again exceeding our expectations. This growth reflects both the increasing adoption by healthcare providers and a rising tide of patient interest and confidence in BRIUMVI.

[Michael Weiss, CEO at TG Therapeutics]

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 BRIUMVI is becoming the go-to anti-CD20 therapy for many of them. 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 BRIUMVI 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 BRIUMVI. Their stories echo findings from a recent paper in Frontiers in Immunology, which highlighted seven case reports of people with MS who switched to BRIUMVI 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 BRIUMVI.

[Michael Weiss, CEO at TG Therapeutics]

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. As I often say, the more people who start BRIUMVI, the more people will start BRIUMVI. Even in a highly competitive market, our team and BRIUMVI's unique profile are rising to the challenge.

[Michael Weiss, CEO at TG Therapeutics]

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 BRIUMVI 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. First, I'd like to highlight our pipeline and efforts to enhance the BRIUMVI experience. A core focus of our innovation strategy is simplifying the patient experience. Our enhanced clinical trial is designed to help us evaluate a number of these strategies and has already yielded some encouraging results.

[Michael Weiss, CEO at TG Therapeutics]

We previously presented data from this study demonstrating the safety and tolerability of a 30-minute maintenance infusion, as well as initiating BRIUMVI treatment with a single full-dose 450 milligram infusion for patients switching from another CD20 who had low B-cell counts. Most recently, at AAN last month, we shared new data showing the safety and tolerability of starting all patients on BRIUMVI with a single 600 milligram dose on day one, effectively eliminating the need for a day 15 dose. Feedback on this streamlined approach has been very positive. We believe patients will appreciate the simplicity of starting treatment with just one infusion visit, making BRIUMVI a true twice-a-year therapy from day one. We are now preparing to advance this regimen into a registration-directed trial. Another exciting initiative is the development of a self-administered sub-Q BRIUMVI.

[Michael Weiss, CEO at TG Therapeutics]

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 is only one available today. We see a clear opportunity to expand access and choice with a self-administered sub-Q BRIUMVI. Our ongoing phase I safety and bioequivalence study is showing promising results. The sub-Q 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 sub-Q formulation may open new doors for us in new indications. One area that we are currently exploring is the potential for sub-Q BRIUMVI in myasthenia gravis, and we're evaluating potential additional indications as well.

[Michael Weiss, CEO at TG Therapeutics]

Finally, on the pipeline front, we continue to be excited about Azer-cel, our allogeneic CD19 CAR T-cell therapy. It's early days for CAR T and autoimmune diseases, but we see great potential across multiple indications. We're excited to launch our phase one for Azer-cel and 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. I want to thank the entire TG team for their dedication and hard work. It's their commitment to our mission that enables us to deliver meaningful progress for individuals with relapsing forms of MS. Now I'll turn the call over to Adam Waldman, our Chief Commercialization Officer. Adam, go ahead.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

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 BRIUMVI in the RMS market. U.S. net sales for BRIUMVI in the Q1 of 2025 were approximately $119.7 million, 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. Based on this performance and the strength of leading indicators, we are increasing our full year 2025 BRIUMVI 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.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

This is despite the headwinds typically seen in the Q1 and an ongoing competitive product launch. Importantly, March was also our highest month ever for repeat prescribers, with physicians coming back to prescribe BRIUMVI again, a strong signal of growing prescriber confidence and satisfaction. Further, we saw continued strength in the hospital setting, which contributed approximately 60% 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 BRIUMVI's life cycle, demonstrating strong persistence trends at week 24 and week 48. While we remain in the competitive marketplace, BRIUMVI continues to stand out. Our five-year data, consistent real-world safety and efficacy profile, combined with our unique one-hour twice-a-year infusion, remain highly compelling to both physicians and patients.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Importantly, we're seeing both an expansion of the CD20 market overall and continued dynamic market share gains for BRIUMVI in the anti-CD20 IV segment, driven by both newly diagnosed patient starts and an increasing volume of switched 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. 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 BRIUMVI television commercial campaign, including full digital surround sound strategy to educate, inspire, and activate eligible patients to seek out BRIUMVI treatment.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Third, our teams will continue to build and leverage real-world evidence to support BRIUMVI's position as a differentiated and trusted anti-CD20 option. Fourth, we will start preparing for life-cycle innovations, including our subcutaneous formulation, which we believe represents a significant long-term growth opportunity. 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 executions. Looking ahead, we are optimistic about the continued growth and potential of BRIUMVI. As I mentioned, based on current trends in both new patient accumulations and persistence, we are raising our full year 2025 U.S. net revenue guidance from $525 million, which we highlighted at JPMorgan in January, to $560 million 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.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

While we are still early into the quarter, we're currently targeting $135 million for the second quarter. With a robust foundation in place, multiple catalysts on the horizon, and a highly differentiated product, we believe BRIUMVI is well-positioned to become a market-leading therapy in RMS. I want to thank our commercial team for their tireless commitment and drive. 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. With that, I'll turn the call over to Sean to walk through our financials. Sean?

[Sean Power, CFO at TG Therapeutics]

Thank you, Adam, and good morning, everyone. Earlier this morning, we reported our detailed Q1 2025 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 Q1 revenue, something Adam and Mike both already touched on briefly. We're very pleased to report U.S. net product revenue of $119.7 million for the Q1 of 2025. This reflects 137% growth compared to the same period last year and a 16% increase over the Q4 of 2024. This continued momentum underscores the strong demand that we're seeing for BRIUMVI. Turning to operating expenses, excluding non-cash items, our total OPEX for the quarter, which includes both R&D and SG&A expenses, came in at approximately $82 million for the quarter.

[Sean Power, CFO at TG Therapeutics]

That's tracking slightly ahead of our full year guidance of approximately $300 million. This increase during the quarter was primarily driven by about $20 million in manufacturing investments for subcutaneous BRIUMVI. We expect these costs charged to R&D to fluctuate from quarter to quarter. Importantly, we remain confident in our full year OPEX guidance of approximately $300 million. On the bottom line, thanks to the continued strong performance of BRIUMVI, we reported GAAP net income of approximately $5 million, or $0.03 per diluted share, for the quarter ended March 31, 2025. Finally, a quick note on our balance sheet. We closed the quarter with $276 million in cash, cash equivalents, and investment securities. 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.

[Sean Power, CFO at TG Therapeutics]

Before concluding, I'd like to offer some initial perspectives on the recent discussions regarding potential tariffs. As you may know, BRIUMVI 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. With that, I will now turn the call over to the conference operator to begin the Q&A.

[Operator]

Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. 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 the handset before pressing the star keys. Again, that's star one to register a question at this time. Today's first question is coming from Tara Bancroft of TD Cowen. Please go ahead.

[Tara Bancroft, Director and Senior Analyst in Biotech Equity Research at TD Cowen]

Hi, good morning, and thanks for taking the question. I was hoping maybe you could provide a little bit more color on competitive dynamics, especially with Ocrevus de novo. 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 what you're hearing, if anything, on preferred uptake of BRIUMVI in new patients versus other treatments. Thanks so much.

[Sean Power, CFO at TG Therapeutics]

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

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Yeah, sure. You know, I think, as I mentioned in my comments, Tara, that we saw the highest three months ever on patient enrollments. We saw a really strong month in April. We believe we're continuing to drive market share gains. We said back at JPMorgan, we think we're getting about 25% of the IV segment. We assume that's up from there, and we continue to see good traction in the marketplace. We are really encouraged by what we're seeing. On the question on de novo, from what we can tell, we've seen zero impact on BRIUMVI.

[Tara Bancroft, Director and Senior Analyst in Biotech Equity Research at TD Cowen]

Great. Thank you so much.

[Sean Power, CFO at TG Therapeutics]

Thank you.

[Operator]

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

[Michael DiFiore, Director and Equity Research Analyst at Evercore ISI]

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. Also, with regards to gross margin, when can we expect you to fully deplete, I guess, the pre-launch reserves in gross margin, and perhaps when could we expect maybe a kind of a decrease there? Thank you.

[Sean Power, CFO at TG Therapeutics]

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

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

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. Sean?

[Sean Power, CFO at TG Therapeutics]

Yeah, sure. Thanks, Mike. We have fully depleted that pre-commercial inventory reserve that you are speaking of. The margins you are seeing this quarter and going forward should be the fully baked number and consistent quarter-to-quarter.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Thanks.

[Sean Power, CFO at TG Therapeutics]

Thanks, Michael.

[Operator]

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

[Roger Song, Equity Analyst at Jefferies]

Great. Congrats for the quarter, and thank you for taking our questions. Maybe the question related to the sub-Q of BRIUMVI, you said you will start a pivotal this year. Just curious, what's the current thinking about how many doses you will move forward, and when we will start to see the PK data, second half? Thank you.

[Sean Power, CFO at TG Therapeutics]

Sure. Thanks, Roger. Yeah. I mean, we're still leaning toward having two dosing regimens in there, so 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. In terms of PK data coming out, probably later this year. We just haven't been as focused. We continue to collect more data. I think we're continuing to work on that study. It's going to lead us right into the trial, then we'll figure out when we present some of the data. 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 still confident in one or the other.

[Roger Song, Equity Analyst at Jefferies]

Thank you.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Thanks, Roger.

[Operator]

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

[Mayank Mamtani, Managing director, group head of healthcare research at B. Riley Securities]

Yes, good morning. Thanks for taking our questions, and congrats on the quarter. On the 30-minute infusion data that also we saw at AAN update, Mike, could you touch on the physician feedback there? Also, how might your data be tracking in depleted and non-depleted patients as you obviously try to understand the switch profile and enhance and broadly about your phase three trial scale and scope? If you could comment on that, that would be helpful.

[Sean Power, CFO at TG Therapeutics]

Sure. With respect to the 30-minute infusion, the feedback has been positive. Actually, maybe, Adam, you've talked to a lot of folks about that as well. You want to touch on the 30-minute infusion, your thoughts there?

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Yeah. I think there's been very positive feedback on the 30-minute infusion. Physicians think it's a convenience for their busy infusion centers. Patients think it's a much more convenient option. The data so far is showing that it's well tolerated. It has been very positive, and physicians have encouraged us to continue to develop.

[Sean Power, CFO at TG Therapeutics]

Thanks, Adam. Yeah. In terms—sorry, guys. Did I cut you off, Adam?

[Mayank Mamtani, Managing director, group head of healthcare research at B. Riley Securities]

No, no. Go ahead. You were kind of comment on phase three. My question, the second part was actually around the R&D spend also, which seems like it's tracking higher. Yeah, if you could factor in the phase three comments there, if that would start this year, for example. Also, as you kind of commented on the SG&A spend for the second half, given the DTC spend commitment, if you could comment on how you're thinking about profitability going forward.

[Sean Power, CFO at TG Therapeutics]

Yeah, Mike, you got a lot in there. I'll try to take it in a few steps, and you can follow up if you like. Just in terms of the pivotal program, I'll just be clear. There are two pivotal programs that we're planning. One is for the combined day one and day 15 dose. That` study, again, should simplify the onboarding of patients. We're looking at the 600 mg—excuse me—600 mg dose on day one and no day 15. That study should start, hopefully, in the next one, two, three months at the latest. That's ongoing. 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 600 mg.

[Sean Power, CFO at TG Therapeutics]

In terms of the R&D spend that Sean mentioned, again, I think the only delta is just the materials that we have to produce to make the sub-Q that hit the R&D line instead of the CMC manufacturing line. I think in terms of our overall R&D spend, we're right on target to what we thought we'd be. In terms of profitability, now let Sean discuss two or three things he could add. I don't think we're highly focused on profitability this year. I mean, I think in terms of the way we view the world, we're not using cash. We should be driving cash through the business. 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.

[Sean Power, CFO at TG Therapeutics]

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? You had a few points.

[Mayank Mamtani, Managing director, group head of healthcare research at B. Riley Securities]

You did cover it all. Thank you, Mike. Lastly, I 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. Thank you for taking our questions.

[Sean Power, CFO at TG Therapeutics]

Yeah, you got it. Yeah. Moving manufacturing is not an easy task. I think we've said it'll be several years before we'll be able to manufacture out of that North Carolina facility. For the moment, I don't think it's a near-term event. It'll take several years. I 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. 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. We're working on it as quickly as we can.

[Sean Power, CFO at TG Therapeutics]

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

[Mayank Mamtani, Managing director, group head of healthcare research at B. Riley Securities]

Understood. Thank you, Mike.

[Operator]

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

[Operator]

Hi, guys. This is Ronan for Eric. Congrats on the quarter. I just wanted to ask, I believe you previously cited expectations of about 70% product adherence between biannual infusions. Do you have a sense of that metric in Q1 and any anticipated fluctuations going forward? Thanks.

[Sean Power, CFO at TG Therapeutics]

Sure. Adam, you want to grab that one?

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

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

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

70% adherence between biannual infusions.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Yeah. I do not remember saying that. 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.

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Okay. Thank you, guys.

[Operator]

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

[Prakhar Agrawal, Vice President and Equity Research Analyst at Cantor Fitzgerald]

Hi. Thank you for taking my questions and congrats on the quarter. Firstly, on sub-Q BRIUMVI, when is the phase pivotal trial expected to start? I think previously you had mentioned targeting mid-year 2025 as the timeline. Is that still on track? Secondly, a question on BRIUMVI outside of MS, what do you need to see for BRIUMVI's profile and indications like myasthenia gravis to make the decision to invest further, especially given we have seen some interesting data from the CD19 drugs in this space, especially Amgen's?

[Sean Power, CFO at TG Therapeutics]

Yeah. Thanks, Prakhar. In terms of sub-Q, yep, still on track. As we said in the prepared remarks, still on track with the sub-Q timelines. In terms of MG data, yeah, I mean, we're definitely moving cautiously forward in that area. 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. 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. I don't think it's one piece of information. I think there's an aggregate of information. 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.

[Sean Power, CFO at TG Therapeutics]

We're going to stay on top of it. We're going to keep pushing forward at a moderate pace. We have the ability to accelerate it at any moment if we feel the time is right.

[Prakhar Agrawal, Vice President and Equity Research Analyst at Cantor Fitzgerald]

Got it. Maybe just one last question. What percentage of BRIUMVI patients right now are switches from Ocrevus? Is this a trend that you're seeing more of an inflection this year? If so, why is that the case?

[Sean Power, CFO at TG Therapeutics]

Adam, you want to go ahead?

[Adam Waldman, Chief Commercialization Officer at TG Therapeutics]

Yeah. We have not seen—I would not say we have seen material changes in the % switches. We still see a healthy amount of switches from Ocrevus. That trend has stayed consistent since launch. No material change. I am sorry, I do not remember the second part of the question. Was there a second part, Prakhar? Okay. Thanks.

[Operator]

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

[Sean Power, CFO at TG Therapeutics]

Great. Thank you, Operator, and everyone. Thanks for joining us. As you can see, we're off to a very strong start in 2025. We are 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 we discussed them in today's call. Of course, meeting our revenue targets that we've set, commencing pivotal trials for the simplified starting dose for IV BRIUMVI and for subcutaneous BRIUMVI, as well as executing on our phase I trials for BRIUMVI in patients with myasthenia gravis and for Azercel in patients with progressive forms of MS. Beyond that, we continue to evaluate opportunities to extend our portfolio of product opportunities across autoimmune and autoinflammatory diseases, and we'll continue our share buyback program.

[Sean Power, CFO at TG Therapeutics]

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 BRIUMVI. It's your courage that inspires everything that we do here at TG. We really do appreciate it. 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.

Participants

Executives

• Adam Waldman, Chief Commercialization Officer
• Sean Power, CFO
• Michael Weiss, CEO
• Jenna Bosco, Chief Communications Officer

Analysts

• Tara Bancroft, Director and Senior Analyst in Biotech Equity Research at TD Cowen
• Roger Song, Equity Analyst at Jefferies
• Michael DiFiore, Director and Equity Research Analyst at Evercore ISI
• Prakhar Agrawal, Vice President and Equity Research Analyst at Cantor Fitzgerald
• Mayank Mamtani, Managing director, group head of healthcare research at B. Riley Securities
• Analyst