TG Therapeutics Q2 2026 Earnings Report

TG Therapeutics EPS Results

• Actual EPS: $0.05
• Consensus EPS: $0.31
• Beat/Miss: Missed by -$0.26
• One Year Ago EPS: $0.17

TG Therapeutics Revenue Results

• Actual Revenue: $240.34 million
• Expected Revenue: $229.77 million
• Beat/Miss: Beat by +$10.56 million
• YoY Revenue Growth: +70.20%

TG Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 8/3/2026
• Time: Before Market Opens
• Conference Call Date: Monday, August 3, 2026
• 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 Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: BRIUMVI sales exceeded expectations, with U.S. net product revenue of approximately $228 million, up 17% sequentially and more than 64% year over year. TG Therapeutics raised 2026 U.S. revenue guidance to $890 million–$905 million and global revenue guidance to approximately $950 million.
• Positive Sentiment: Commercial momentum remains strong, including record new patient starts, expanding physician adoption, improving persistence, and increasing use in treatment-naive patients. Management expects to exit 2026 at a quarterly U.S. revenue run rate above $250 million, implying its first billion-dollar annualized run rate.
• Positive Sentiment: The company reported positive Phase III ENHANCE results supporting a simplified single-infusion BRIUMVI initiation schedule, potentially available by mid-2027, while its quarterly subcutaneous formulation remains on track for Phase III results around year-end 2026 or early 2027 and could expand the addressable market substantially.
• Positive Sentiment: TG is expanding BRIUMVI beyond relapsing multiple sclerosis, advancing a registration-directed Phase II myasthenia gravis study and a Phase II treatment-resistant schizophrenia study. The azer-cel allogeneic CAR-T program has enrolled more than 20 patients across MS and other B-cell-mediated diseases, with a clinical update expected in the second half of 2026.
• Negative Sentiment: Reported operating income and net income were limited by approximately $55 million of subcutaneous and secondary-source manufacturing charges in the quarter; TG expects about $100 million of such expenses for full-year 2026, in addition to $350 million–$400 million of underlying operating expenses.

Presentation

[Operator]

Greetings. Welcome to TG Therapeutics' second quarter conference call. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll turn the conference over to Jenna Bosco, Chief Communications Officer. Thank you. You may begin.

[Jenna Bosco, CCO at TG Therapeutics]

Thank you. Welcome, everyone, thank you for joining us this morning. I'm Jenna Bosco, with me to discuss TG Therapeutics' second quarter 2026 financial results are Michael Weiss, our Chairman and Chief Executive Officer, Adam Waldman, our Chief Commercial Officer, Sean Power, our Chief Financial Officer. Following our safe harbor statement, Mike will begin with an overview of our recent corporate developments, Adam will provide an update on our commercial efforts, Sean will review our financial results before we open the call for Q&A. Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include expectations regarding our future operating and financial performance, including sales trends, revenue guidance, projected milestones, development plans, outlook for our marketed products and pipeline products.

[Jenna Bosco, CCO at TG Therapeutics]

Please note that these statements are subject to risks and uncertainties that can 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, 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 will turn the call over to Mike Weiss, our CEO.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thank you, Jenna, good morning, everyone. We appreciate you joining us. The second quarter of 2026 was another quarter of strong execution. More importantly, it marked an important evolution for TG Therapeutics. For the last several years, we've been singularly focused on one objective, establishing BRIUMVI as a leading therapy in relapsing multiple sclerosis. That remains our highest priority today and will remain so for years to come. Increasingly, BRIUMVI is enabling us to build something much bigger. It really represents the starting line for TG, the starting line for continued innovation from new formulations and new indications to novel therapeutic approaches to thoughtful business development, ultimately for building an organization capable of repeatedly creating value for patients and shareholders. The second quarter provided a window into where we're headed. From a commercial perspective, we delivered another excellent quarter, once again exceeding our guidance.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

New patient starts continued to grow, physician adoption expanded, our commercial organization continued to execute at an exceptionally high level. As we approach a billion-dollar annualized run rate, we continue to believe we're still early in the life cycle of the BRIUMVI franchise. Our objective is straightforward, to become the number one prescribed anti-CD20 therapy in relapsing MS based on dynamic market share. We're making meaningful progress toward that goal, not only by continued commercial execution, but also by ongoing product innovation and a growing body of real-world evidence demonstrating the BRIUMVI value proposition. During the quarter, we announced positive top-line phase III results from our ENHANCE study, demonstrating that patients can initiate BRIUMVI with a single 600-milligram infusion, replacing the currently approved day one and day 15 initiation schedule.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Based on feedback from healthcare providers, the ability to initiate BRIUMVI with a single infusion will be viewed very positively by both patients and infusion centers. Eliminating the need for an additional infusion visit reduces treatment burden and removes one of the barriers to switching from another anti-CD20 therapy to BRIUMVI. If all goes well, this new initiation schedule could be available as early as the middle of next year. We also reported additional real-world data from our ongoing ENABLE phase IV study, demonstrating significant and durable improvements in patient-reported outcomes on BRIUMVI. Importantly, patients transitioning from prior anti-CD20 therapies maintained strong disease control while also reporting meaningful improvements in convenience, tolerability, and overall treatment satisfaction. While we continue to strengthen our position within the IV anti-CD20 market, we also made significant progress during the quarter advancing subcutaneous ublituximab, the active agent in BRIUMVI.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

We reported positive phase I bioavailability data for our proprietary subcutaneous formulation, increasing our confidence in the quarterly dosing schedule that is being evaluated in our fully enrolled phase III study. We're expecting top-line phase III results around year-end or early next year. To be clear, subcutaneous BRIUMVI is not simply another formulation. It has the potential to materially expand the reach of the franchise. Today, we participate in the physician-administered segment, representing approximately 60%-65% of the overall anti-CD20 market. A successful subcu BRIUMVI would allow us to compete for patients who choose a self-administered therapy, giving us the opportunity to participate across the entire anti-CD20 landscape for RMS. When pricing dynamics are considered, the subcu opportunity has the potential to more than double BRIUMVI's current addressable market.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

When you combine the strength we're already seeing in the IV franchise with the potential to have a best-in-class subcutaneous product, we continue to believe the long-term opportunity for the BRIUMVI franchise is substantially greater than many appreciate today. Beyond MS, we've begun extending the reach of BRIUMVI into additional autoimmune-mediated diseases. During the quarter, we announced encouraging preliminary phase I data in patients with myasthenia gravis and initiated what we believe could be a registration-directed phase II study. There are now multiple treatment options available for MG, but our approach, combining the rapid symptomatic relief of FcRn inhibition with the possibility for durable disease control with BRIUMVI, has the potential to represent a meaningful treatment advance by reducing the long-term treatment burden of FcRn inhibition and optimizing disease control. We also initiated a phase II study in treatment-resistant schizophrenia.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Growing evidence suggests that a subset of treatment-resistant patients may have an underlying autoimmune component to their disease. Our study is designed not only to evaluate clinical outcomes, but also to better characterize that biology through biomarker analysis. The current investment is modest, but the potential upside, if the biology proves correct, could be significant, and we continue to evaluate additional opportunities to expand BRIUMVI. Finally, I'd like to discuss azer-cel, our allogeneic CD19 CAR T program. We continue to make encouraging progress. We have now enrolled more than 20 patients, primarily with progressive forms of multiple sclerosis, and recently expanded the study to include additional B-cell-mediated diseases. While we're focused on generating rigorous clinical evidence before drawing conclusions, we've been encouraged by the continued enthusiasm from investigators, strong patient interest, and the anecdotal reports emerging from some study participants.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

We're looking forward to sharing a clinical update during the H2 of the year. When I step back and look at everything we accomplished during the quarter, continued commercial execution, positive ENHANCE data, growing real-world evidence from ENABLE, encouraging progress with subcu, expansion into MG and schizophrenia, and continued advancement of azer-cel. I see a strategy coming to life. One successful product becoming a durable engine for innovation. Our goal isn't simply to build a great product, it's to build an organization that repeatedly creates great products for patients and great opportunities for our shareholders. Before turning the call over to Adam, let me briefly touch on our capital allocation. Our philosophy remains unchanged. We will continue to invest where we believe we can create the greatest long-term value. That means, first and foremost, investing behind BRIUMVI and our commercial efforts.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Advancing our pipeline and pursuing strategic business development opportunities that strengthen our long-term vision and generate attractive returns. When appropriate, continuing to repurchase our own shares. Every capital allocation decision begins with the same question. Where can we create the greatest value per dollar invested? That discipline has served us well and will continue to guide us. With that, I'll turn the call over to Adam Waldman, our Chief Commercial Officer. Adam, please go ahead.

[Adam Waldman, CCO at TG Therapeutics]

Thanks, Mike, and good morning, everyone. I'm delighted to provide a commercial update. Performance was once again very strong. Second quarter was another record quarter of new patient starts, which surpassed our prior record seen in the first quarter. Persistence continues to exceed our expectations. We're adding new prescribers. Repeat prescribers continue to increase. Importantly, an increasing percentage of patients are beginning their treatment journey with BRIUMVI rather than switching to us later. We highlighted that trend last quarter as one of the strongest leading indicators of long-term franchise strength. The second quarter reinforced that view. When you combine a growing installed base, record new patient demand, strong persistence, and expanding physician adoption, you create a business that becomes more durable and more predictable over time. That's exactly what we're seeing in our business today with another excellent quarter.

[Adam Waldman, CCO at TG Therapeutics]

We generated approximately $228 million in U.S. BRIUMVI net product revenue, with global revenue exceeding $240 million, once again exceeding our guidance. In the U.S., that represented quarter-over-quarter growth of approximately 17% and year-over-year growth of more than 64%. Based on the strength of the business, we are raising our full-year U.S. BRIUMVI net revenue guidance to $890 million-$905 million, and now expect approximately $950 million in total global revenue for 2026. Looking to the balance of the year, we expect the fourth quarter to drive second-half growth, positioning us to exit 2026 with quarterly U.S. net revenue exceeding $250 million, our first billion-dollar annualized revenue run rate, and setting the stage for our first billion-dollar+ U.S. BRIUMVI revenue year in 2027. Building a blockbuster brand in less than four years doesn't happen by accident.

[Adam Waldman, CCO at TG Therapeutics]

It's the result of disciplined execution and relentless focus on the fundamentals that matter most. Over the past several years, we have built a commercial platform designed not simply to launch a product, but to support a long-duration franchise. Our field organization, market access capabilities, patient support services, and direct-to-consumer investments continue to make BRIUMVI easier to prescribe, easier to access, and easier to remain on. We have also been encouraged by the early response to our direct-to-consumer campaign and plan to expand those efforts during the H2 of the year. We believe increasing patient awareness complements the commercial infrastructure we have built and represents another important driver of long-term growth. As the business continues to grow, we are able to leverage that commercial platform across an expanding franchise, creating increasing operating leverage over time. Looking ahead, we see two important opportunities to build on our MS franchise.

[Adam Waldman, CCO at TG Therapeutics]

The first is the new simplified IV initiation schedule supported by the positive ENHANCE phase III results. If approved, initiating patients with a 600 mg infusion further enhances an already strong IV offering, and we believe it will fuel additional share gains within the IV marketplace. It reduces complexity for physicians, for infusion centers, and most importantly, for patients. The second opportunity is subcu BRIUMVI. Today, approximately 35%-40% of the dynamic anti-CD20 market consists of patients receiving self-administered therapy, a segment where we don't currently participate. A successful subcu BRIUMVI program would allow us to compete directly in that segment with what we believe could be a highly differentiated product. The more important point is how we think about these opportunities together.

[Adam Waldman, CCO at TG Therapeutics]

While they are two products, they will represent one franchise powered by the trusted efficacy and safety profile of BRIUMVI that HCPs have already prescribed to more than 30,000 patients globally today. Our goal isn't to ask physicians or patients to choose between IV and subcu. Our goal would be to ensure whichever route of administration best fits an individual patient's need, there is a compelling BRIUMVI option. That allows us to compete across the entire anti-CD20 RMS market with a single trusted brand supported by one commercial organization, one reimbursement infrastructure, one patient support platform, and one field team. That's powerful, and it's another example of how the operating leverage of this business continues to improve over time.

[Adam Waldman, CCO at TG Therapeutics]

When you step back and consider the size of the IV market, the portion of the market we'll be able to access with subcu, the trajectory we're seeing today, and the commercial infrastructure we've already built, it's easy to see why the long-term opportunity for the BRIUMVI franchise is substantially larger than where it sits today and reinforces our confidence that BRIUMVI has the potential to become the leading therapeutic in this category over time. We're building that opportunity on top of a patent estate extending into the 2040s. That gives us confidence to continue investing in the brand, investing in life cycle innovation, and investing in the commercial platform because we believe those investments will continue generating value for many years to come. When I look at the business today, I don't see just another strong quarter.

[Adam Waldman, CCO at TG Therapeutics]

I see a commercial franchise that's becoming stronger, expanding its patient base, deepening physician adoption, demonstrating strong persistence, and creating increasing operating leverage. We remain confident that we're still in the early innings of realizing BRIUMVI's full potential. With that, I'll turn the call over to Sean.

[Sean Power, CFO at TG Therapeutics]

Thanks, Adam. A lot of what you just heard from Mike and Adam shows up in the financials. Let me take you through the details. U.S. net product revenue in Q2 was approximately $228 million, up 64% versus the same quarter last year. Total net product revenue was $236 million, when including product sales to our ex-U.S. partner. Add in $4.5 million of license, royalty, and other revenue, and total revenue for the quarter was $240 million. In terms of margins, the gross margin of our U.S. business remains remarkably consistent and predictable at approximately 87%. When factoring in sales to our ex-U.S. partner and other revenue sources, total gross margin landed at 83% for the quarter, in line with our expectations.

[Sean Power, CFO at TG Therapeutics]

On the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based compensation, was approximately $150 million for the quarter, including roughly $55 million of charges associated with subcutaneous and secondary source manufacturing activities. Excluding those, underlying OpEx was about $95 million, consistent with our expectations and down from Q1. As a reminder, our 2026 OpEx projections include approximately $100 million for these manufacturing activities. We call those costs out separately because they are expensed through R&D as incurred, and while not all of it converts to saleable inventory, a meaningful portion does, which would represent a gross margin tailwind in future periods if the programs are successful. The result was operating income of $21.7 million for the quarter and net income of $7.8 million or $0.05 per diluted share.

[Sean Power, CFO at TG Therapeutics]

Excluding the manufacturing charges I referenced earlier, operating income would have been approximately $76 million, a meaningful step-up from both Q1 and the prior year period. On the same basis, net income comes to approximately $62 million, and that's the number we'd point you to as the better reflection of our underlying earnings power. Turning to the balance sheet. We ended the quarter with approximately $612 million in cash equivalents, and investment securities.

[Sean Power, CFO at TG Therapeutics]

On revenue guidance, U.S. BRIUMVI net revenue through the H1 was approximately $423 million, on track for our full-year target of $890 million-$905 million. Total revenue of approximately $445 million puts us equally well-positioned against our $950 million full-year global target. In terms of expenses, we expect full-year OpEx of $350 million-$400 million, excluding stock-based compensation, reflecting continued investment in our commercial organization and expanded DTC efforts. On top of that, we expect approximately $100 million for the manufacturing-related expenses I referenced earlier. All in, it was another strong quarter financially. As Mike and Adam have laid out, we believe the best is still ahead of us. With that, I'll now turn the call back over to the conference operator to begin the Q&A.

[Operator]

Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment for our first question, please. Thank you. The first question today comes from the line of Tara Bancroft with TD Cowen. Please proceed with your question.

[Greg Torres, Analyst at TD Cowen]

Hey, good morning. This is Greg Torres on for Tara. Thanks for taking our question. As you evaluate the long-term opportunity for subcu BRIUMVI, how different are your peak sales assumptions under a quarterly dosing regimen versus a more frequent every two months regimen? Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

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

[Adam Waldman, CCO at TG Therapeutics]

Yeah. Thanks for the question, Greg. In general, we do think a less frequent dose is going to be better than a more frequent dose.

[Operator]

Thank you. The next question is from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your questions.

[Prakhar Agrawal, Analyst at Cantor Fitzgerald]

Hi. Congrats on the quarter. Thanks for taking my questions. Maybe firstly on the subcu BRIUMVI, since this will be a Part D product, just curious how you'll approach the pricing here and contracting compared to KESIMPTA, since you could have a quarterly regimen here. Any sort of initial comments on how do you think the uptake will be given the brand familiarity here? Maybe just a couple of clarifications. On the OpEx increase, if you can elaborate on how much of that is driven by R&D, given some of the pipeline investments versus SG&A. A clarification on the BRIUMVI sales that you provide to Neuraxpharm ex U.S. seems like a meaningful increase in $25 million for the guide.

[Prakhar Agrawal, Analyst at Cantor Fitzgerald]

Are there some one-offs here to Neuraxpharm for this year for ex-U.S. buildup, or are you expecting more meaningful royalty contribution from ex-U.S., given this increase in ex-U.S. supply? Just to clarify, if the sales to Neuraxpharm is done at a cost plus some markup on the revenue line item. Thank you so much.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Prakhar, thank you for that five-part question. We'll try to break that down. Adam, do you want to start us off with some thoughts on subcu Part D pricing and contracting and potential uptake?

[Adam Waldman, CCO at TG Therapeutics]

Sure. Yeah. Thanks for the question, Prakhar. On the subcu side, we're not going to talk about pricing yet. We've still got a little bit of time here. We'll do the work that we need to do. We do think we can price it competitively in the market, and we'll take into account all the different factors you need to take into account. As far as uptake, we feel really good about the profile of the drug. We think the uptake will be strong. We continue to do market research, and we'll continue to do more as we get closer to launch here. The profile that we have in mind, we think will do quite well in this space.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah, I'll just layer on top of that. Adam and the team do proper market research. I do my own work when I go out on the field. I've been out in the field probably six or seven days in the last 21 days, meeting with clinicians at primarily large academic centers. I can tell you the enthusiasm and excitement for the subcu product is pretty incredible, actually. Pretty impressive. Particularly, it's really interesting. Most of the people have heard about what we're doing, so the pre-educated teams have been out there. They see the data online and wherever. People who haven't yet realized that we're targeting a quarterly product that's in an auto-injector, their eyes light up.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

I think everyone is somehow thinking that you can't do this kind of a thing with taking an IV to a subcu, and yeah, it's really interesting to see how excited they get. Like I said, Adam's doing the market research on the uptake properly, but I got to tell you, anecdotally, out in the field, when I talk to folks, they're pretty enthusiastic about it. I'll layer on top of that, they're also super excited about the enhancements through the consolidated dosing. I think that's something that's also going to be pretty interesting in how that impacts the uptake next year. All right. The part two of your question, OpEx drivers, slightly guidance a little higher on the OpEx for the year. Sean, you want to take a crack at the distribution there, R&D, SG&A?

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Prakhar, to your point, yes, we've extended R&D, but I'll layer in and then, Sean, you can add on top. Adam and his team have done a really nice job piloting some DTC campaigns, and I think we're going to lean into some of that, both on the commercial side, but also online. I think you'll see some of that showing up. Sean, maybe what else can you add to that?

[Sean Power, CFO at TG Therapeutics]

Yeah. I think you covered it on the SG&A side, Mike. Of course, Prakhar, as you know, we call out the $100 million in subcutaneous manufacturing, secondary source manufacturing costs as well. We factor that into overall guidance as well. I think the combination of those two things should cover it. I think your last question was on NXP ex-U.S. revenue for the rest of the year. We do model in some continued product revenue, as you noted that we've seen throughout the H1 of the year. There is some other, of course, license and milestones related revenue that we model in for the remainder of the year, which drives that overall global revenue guide.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah.

[Prakhar Agrawal, Analyst at Cantor Fitzgerald]

Thank you. Appreciate you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Prakhar, I'll just layer on top. They are moving along pretty well on driving revenues, royalties are picking up a bit. Yeah, in the H2, it's probably more related to milestones and other payments that they'll owe us.

[Prakhar Agrawal, Analyst at Cantor Fitzgerald]

Thank you. Appreciate it.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thanks, Prakhar.

[Operator]

Our next questions are from the line of Michael DiFiore with Evercore ISI. Please proceed with your questions.

[Michael DiFiore, Analyst at Evercore ISI]

Hi, guys. Thanks so much for taking my questions. Two from me. Roche recently said that anti-CD20 competition was running above expectations, and moved OCREVUS growth to the low end of its range. Are you seeing acceleration in BRIUMVI's share gains, and is that coming more from OCREVUS switches or treatment-naive starts? My second question is related to the schizophrenia study. What result would you consider strong enough to justify a larger randomized study? Yeah. I'll just leave it there. Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Sure. Thanks. Adam, maybe take the Roche anti-CD20 competitive issues that they're facing in the marketplace, which I assume was referring to us, which is interesting because people, I guess, didn't really think we could compete with Roche, but apparently they do believe so. Adam, do you want to take that, and I'll take the schizo question second.

[Adam Waldman, CCO at TG Therapeutics]

Sure. Yeah. Thanks for the question. Listen, this is certainly a competitive market space, and we've competed alongside the new product from a new formulation from Roche for several quarters, and we continue to grow our new patient business two record quarters in a row. We continue to grow through the increased competition. In terms of your question of where we're seeing it, we're seeing it from both switches from OCREVUS and treatment-naive patients. As I mentioned in our prepared remarks, I think the growth in naive patients reflects increasing physicians' confidence in the brand and starting with BRIUMVI, which we see as a really important indicator of long-term share growth and confidence in the brand. Then importantly, from switching from OCREVUS, we do know that they're encouraging switches from their IV version to their subcu version.

[Adam Waldman, CCO at TG Therapeutics]

Despite that, we're still continuing to see strength in patients switching over from OCREVUS to BRIUMVI. We do see I think a lot of their business is coming from that switching, as opposed to coming from BRIUMVI itself.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah. Thank you, Adam, for that. Appreciate that. In terms of schizophrenia and the results that we would like to see to move on to phase III. Michael, the study is designed. We took a page out of our old oncology playbook. It's designed as a Fleming two-stage design. You basically assume that there's a certain placebo rate that we've derived from the literature, and that a good drug would have a certain rate of response, a PANSS response. We compare those two in two steps, to see if you can sort of reach the hurdle. If we reach the hurdle rate of responders, again, as it's designed, it's set up against a historical placebo rate, and you've got to get above a certain hurdle, I think we'd be pretty confident to move forward.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

If we're below that, obviously we'll look at the data and see. Again, this is where biomarkers might come in to be helpful. If the biomarkers are saying there's a subgroup that makes more sense, we could then probably more likely rerun the smaller kind of study, the Fleming two-stage design on that and confirm that is predictive or not. At the end of the day, this is a design that can move very quickly, give us some really robust preliminary information and give us an opportunity to move forward. We'll keep you posted. The ideal is we'll get the response rate that we're expecting from the broader population that we're studying. Again, we're doing the bio analysis to check and see what else is possible and what we can learn from it.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

The main driver is going to be the response rate that we get.

[Michael DiFiore, Analyst at Evercore ISI]

Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thank you.

[Operator]

The next questions are from the line of Emily Bodnar with H.C. Wainwright. Please proceed with your questions.

[Emily Bodnar, Analyst at H.C. Wainwright]

Hi. Good morning. Thanks for taking the question. You guys too from me as well. It looks like in the second quarter, majority of growth in the MS market is kind of coming from the subcutaneous side. Curious as you kind of advance and eventually commercialize BRIUMVI subcutaneous, how you see the IV market growing past that point. Secondly, you mentioned you've started some new indications for the azer-cel trials besides MS. Can you clarify which those are? Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Sure. Adam, you want to talk about subQ growth over time and how that impacts IV growth in the future?

[Adam Waldman, CCO at TG Therapeutics]

Sure. I mean, look, our plan is to give people choice, given we'll have an option in both markets. We believe these are fundamentally two different markets, a physician-administered market and a self-administered market. Today we compete in the IV space, and the subcu will provide us the opportunity to expand into the self-administered market. That will substantially increase our market. Strategically, we think about it as one BRIUMVI franchise. I think different patients will have different preferences for route of administration. Our objective is to have a compelling BRIUMVI option, regardless of which approach best fits an individual patient, which allows us, obviously, to compete across the entire RMS space with one trusted brand when all the things that I said. We think that's a significant competitive advantage for the franchise overall.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah. I'll put an exclamation point on that. I mean, we are fully committed to supporting our IV brand as we move forward. Creating a subcu is about patient empowerment, patient choice. We want to show up where the patients want to be. We want to make sure everyone has a BRIUMVI option. We don't know exactly where the market is going over time. The subcu distribution does oscillate quarter-to-quarter. Sometimes it's 30%, sometimes it's 35%. We don't know if it's going to break out and become something different over time. Either way, we want to be prepared to make sure that patients have a choice. As for your azer-cel question, we expanded the study into relapsing MS, MG, CIDP and NMO.

[Emily Bodnar, Analyst at H.C. Wainwright]

Great. Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thank you, Emily.

[Operator]

The next questions are from the line of Brian Cheng with JPMorgan. Please proceed with your questions.

[Brian Cheng, Analyst at JPMorgan]

Yes. Thanks for taking a question this morning. Congrats on the quarter. Let me just first, can you give us a bit more color around your updated U.S. net product revenue guidance? How is the rate reflective of your latest thinking of the IV uptick for the rest of the year? Secondly, on MG, it'd be great to hear how you're thinking about the opportunity here based on the post-AFQAR induction setting that you're aiming for in the trial. What are some of the patient characteristics that you expect to capture in a study that may ultimately differentiate yourself from other historical MG trials? Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thank you. Adam, you want to take a crack at the first part of that question on the guidance?

[Adam Waldman, CCO at TG Therapeutics]

Sure, yeah. First of all, we're excited about the H2 of the year and then raising our annual guidance again for the second time this year, so that's great. I think the best way to think about it, about the H2 is exactly how we outlined it in our prepared remarks. We continue to expect the fourth quarter to be the driver of the H2 growth. Again, we've raised the annual guidance here based on the strength of what we've seen in the H1 with the fundamentals that we're seeing good progress in. Record new patient starts, excellent persistence, and continued physician expansion. All of that is giving us the confidence to raise here, and we feel good about the full year trajectory.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah. Again, I'll just put an exclamation point on that. I think during the course of the year, we've already raised our guidance somewhere in the order of $75+ million. We're going to continue to drive, and we're looking forward to our end of year coming out of an exit velocity of a billion-dollar run rate, which we think is pretty impressive. I know Adam discussed it in the script, I won't say more about that. On the MG and how we're thinking about it. MG is becoming a better-served marketplace. If you look at how the treatments are delivered today, it's my words, maybe not others, but it's a little clunky. You basically put a person into a really good symptomatic place relatively quickly using FcRn inhibition.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Then you wait and let the symptoms come back, then you treat again. It's a pretty intensive program. I mean, it's not the worst schedule, once a week or every other week or whatever they're doing and they're improving upon. It's still a little. Definitely a treatment burden involved with that. The idea here is we can leverage that kind of rapid symptomatic relief of FcRn inhibition, and hopefully layer in the long-term durability of response with something like BRIUMVI. You put the two pieces together and hopefully you have a treatment that is really tailor-made for this kind of a population. Get them into symptomatic remission quickly, keep them there by using BRIUMVI, whether it's every six months or quarterly.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

I think quarterly would be a really nice option for patients to be able to do it at home and really would simplify, I believe, the treatment burden. Yeah, we think there's room for improvement, and anytime there's room for improvement, there's an opportunity.

[Brian Cheng, Analyst at JPMorgan]

Thank you.

[Operator]

The next question is from the line of William Wood with B. Riley Securities. Please proceed with your questions.

[William Wood, Analyst at B. Riley Securities]

Thanks very much for taking our questions and congrats on a very nice quarter. When we're thinking about sort of the second half and the year-end guidance, your fourth quarter or your $1 billion exit runway implies a fourth quarter of around $250 million, which leaves third quarter relatively flat. How should we sort of think about what may be driving that third quarter decrease or flatness maybe, seasonality or growth net or potentially channel changes? Coming away from fourth quarter and looking towards potentially into 2027, how should we think about the growth trajectory into 2027 and how do we start to think about the more meaningful focus of, I guess TG a little bit more broadly? Is it BRIUMVI IV or is it sort of the addition of the subQ coming to market? Thanks.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Yeah. I'll lead off with the second half of that question. I'll let Adam take some part of that first question. Obviously, we haven't given guidance yet for 2027, we'll do that hopefully early next year as we've done in past years. We're certainly feeling good about where we're heading. In terms of the overall franchise, look, we think that we have multiple pieces that will continue to drive growth. Next year, ideally, we'll have ENHANCE with the consolidated dosing, which should hopefully give us another growth expansion. subQ is an order of magnitude change, right? We're talking about something that is of size comparable to the current market, if not larger than the current market that we're currently serving. The current market we're serving, we're not even close to, in our belief, to full saturation of our market share.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

2027, I think is going to be a really exciting year for us. Like I said, with the launch, hopefully sometime in the middle of the year, we could see some really interesting share gains. Once we get into 2028 subQ, it's a whole another ballgame. I think we're not there yet to give any guidance for 2027, but I think we're in a great place leading into that. Adam, any thoughts on Q3, Q4 dynamics?

[Adam Waldman, CCO at TG Therapeutics]

Sure. Yeah. Listen, we've talked about this before on the call. Certainly as we move across the year, each quarter has some unique dynamics, with Q3 having some seasonal dynamics at play, not just for BRIUMVI, but the entire MS market. We're simply too early in the quarter to know exactly how it would land. I think what we have greater visibility and confidence is the H2 in aggregate. That's why we felt comfortable raising the full year guidance. How exactly it plays out between quarters is not much of our concern. We don't concern ourselves too much about it. We're more focused on the full year guidance. As I said, I think the best way to think about the H2 is how we outlined it, where we continue to expect fourth quarter to be the driver of the H2 growth.

[William Wood, Analyst at B. Riley Securities]

Got it. Appreciate that. Thank you.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thank you.

[Operator]

The next question is from the line of Cha Cha Yang with Jefferies. Please proceed with your questions.

[Cha Cha Yang, Analyst at Jefferies]

Hi, team. This is Cha Cha on for Roger. Thanks so much for taking our questions and congrats on another great quarter. I have two questions here from us. One is whether you can speak more to your plans for your DTC campaign expansion and what we can expect to see from that going forward. Two is, you talked about persistence being longer than you expected, whether you can talk more about what's driving that. Thanks.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Sure. Adam, I think this is all you. Go ahead.

[Adam Waldman, CCO at TG Therapeutics]

Sure. Thanks for the question, Cha Cha. As I said in my remarks, I think the responses to what we have done so far in the DTC arena has been positive. All the leading indicators have been trending in the right direction. Gives us confidence to expand it here. You can expect more of an omni-channel presence across digital, linear television, connected television, social channels, and sort of putting a full complement of assets in the market. Again, we're excited about it and the leading indicators so far give us the confidence to continue to do that. As far as your question on persistence, we continue to see really good persistence here and continues to be better than what we've expected. We think that these patterns are basically driven that when patients do well, they stay on therapy.

[Adam Waldman, CCO at TG Therapeutics]

We think it's a sign of confidence in BRIUMVI. We'll continue to track it. We're still relatively early in the life cycle of this brand. So far, we're very encouraged by the persistence trends that we continue to see.

[Cha Cha Yang, Analyst at Jefferies]

Great. Thank you for that.

[Operator]

Thank you. Our next question's from the line of Prakhar Agrawal with Cantor Fitzgerald. Please proceed with your questions.

[Prakhar Agrawal, Analyst at Cantor Fitzgerald]

Hi. Thanks for squeezing me again. Had a lot of questions this quarter, Mike. Firstly, on growth to net, if you can just comment on the growth net for the quarter. I think you have previously said 65%, so how did it track relative to your expectations, and how should we think about growth to net for the rest of the year? Secondly, we are seeing some consolidation happening in the mid-cap biotech space. You have predictability around cash flows, especially meaningful cash flows starting next year. What's the appetite for doing something meaningful on the BD front, or are you looking at more opportunities more on the earlier side? Thank you so much.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Thanks, Prakhar. Adam or Sean wanna talk about the GTN for the remainder of the year?

[Adam Waldman, CCO at TG Therapeutics]

Sure. Yeah. Growth to net is basically unchanged from what we said. We predicted to be in the mid-sixties. That prediction is still accurate.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

More on the biz dev side, strategic side, Prakhar. Our goal is always to maximize shareholder value. As I said in our discussion on capital allocation, we continue to ask the question every day, what is the best use of our money? How can we best invest it? To me, obviously, it's an interesting part of the business. From my prior years as a hedge fund manager, I get to really think about the best way to create value for shareholders. As everyone knows, I'm probably the largest single shareholder, so I do care about how we spend our money and how we invest it. Yeah, I think we're building a company that we do think has predictable cash flow and growing and will be growing for quite some time.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

We have patents out to the mid-2040s. I think the durability of this franchise is far beyond what most people, I think, on the sell side are modeling today. I think that probably should be adjusted. All that's a long way of saying we're going to continue to build a company that creates shareholder value. We're going to continue to look for opportunities out there. We're not looking for any major consolidation plays. I think we continue to look for, on our side, on the inbound side, we look for things that will create value without stressing our bank accounts. We think that there are a lot of interesting single assets or potentially even small companies, but mostly single assets, that we can add to the company.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

One of the things we like to think about is wherever BRIUMVI can go next and azer-cel can follow, we'd like to think about what other pieces we could put together in those areas. As we continue to build out into some of these new therapeutic indications, the lead will always be around where can BRIUMVI work, where can azer-cel work, because there would be a lot of overlap between those two. Then are there other mechanisms of action within those therapeutic areas that could be applied to satisfy the needs of that patient population? That's how I think we're thinking about it. Again, our goal is always to create and maximize long-term shareholder value. We understand that when we do that, we, of course, will create the most opportunities for us and our shareholders.

[Operator]

Thank you. At this time, we've reached the end of our question and answer session. I'll hand the floor back to Mike Weiss for closing comments.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

Great. Thank you. Thanks, everyone, for joining us. Just a quick summary on the Q2 progress. I think we really had another really strong quarter. We generated positive phase III data from the ENHANCE trial. We advanced our subcu BRIUMVI toward a pivotal readout later this year or early next. We expanded BRIUMVI into new autoimmune and mediated diseases. We continue to advance azer-cel. As you heard from Adam, we raised our guidance to $890 million-$905 million just in the U.S. alone and globally approaching $950 million. We continue to see BRIUMVI as a multi-billion-dollar franchise in the making. I can't emphasize that enough. Creating value for our shareholders is our top priority. BRIUMVI, as we said, becomes really the beginning of what we're working on to create value.

[Michael Weiss, Chairman, President, and CEO at TG Therapeutics]

It becomes the lead of everything that we focus on. Finally, just want to thank our shareholders for their continued support, our employees for their commitment to our mission, and the patients, of course, who we serve, and the healthcare professionals who continue to place their trust in us. We take that really seriously. Thanks again for that. Thank you all for joining us. Have a great day.

[Operator]

This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation

Participants

Executives

• Jenna Bosco, CCO
• Michael Weiss, Chairman, President, and CEO
• Adam Waldman, CCO
• Sean Power, CFO

Analysts

• Greg Torres, Analyst at TD Cowen
• Prakhar Agrawal, Analyst at Cantor Fitzgerald
• Michael DiFiore, Analyst at Evercore ISI
• Emily Bodnar, Analyst at H.C. Wainwright
• Brian Cheng, Analyst at JPMorgan
• William Wood, Analyst at B. Riley Securities
• Cha Cha Yang, Analyst at Jefferies