TGTX

It has been about a month since the last earnings report for TG Therapeutics (TGTX). Shares have added about 15.1% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is TG Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. TG Therapeutics reported earnings of 5 cents per share for the second quarter of 2026, missing the Zacks Consensus Estimate of 41 cents. The company had reported earnings of 17 cents per share in the year-ago quarter. Total revenues in the second quarter were $240.3 million, up almost 70.3% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi. The figure beat the Zacks Consensus Estimate of $231 million. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $235.8 million in the reported quarter, reflecting a 69.9% year-over-year increase. Total product revenues included sales of Briumvi to TG Therapeutics’ licensing partner, Neuraxpharm, in ex-U.S. markets, of $8.1 million. Briumvi's net product sales in the United States were $227.7 million in the second quarter, up 64% year over year. Sales of the drug came in ahead of management’s guided range of $220 million. License, milestone, royalty and other revenues were $4.5 million in the second quarter, compared with $2.3 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding stock-based compensation) surged 217.5% year over year to $87.3 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation) totaled $62.3 million, up 43.2% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of June 30, 2026, TG Therapeutics had cash, cash equivalents and investments worth $612.3 million compared with $572.8 million as of March 31, 2026. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $950 million in 2026, compared with the previous expectation of around $925 million. The company now expects net product revenues of $890-$905 million from Briumvi sales in the United States in 2026, up from the previous expectation of $885-$900 million. Excluding non-cash compensation, total operating expenses, defined as R&D and SG&A, are now expected to be around $350-$400 million in 2026, compared with the previous expectation of around $350 million. It turns out, estimates revision have trended downward during the past month. At this time, TG Therapeutics has a poor Growth Score of F, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a score of D on the value side, putting it in the bottom 40% for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, TG Therapeutics has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. TG Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Alnylam Pharmaceuticals (ALNY), a stock from the same industry, has gained 12.4%. The company reported its results for the quarter ended June 2026 more than a month ago. Alnylam reported revenues of $1.29 billion in the last reported quarter, representing a year-over-year change of +66.9%. EPS of $1.84 for the same period compares with $0.32 a year ago. For the current quarter, Alnylam is expected to post earnings of $2.19 per share, indicating a change of -24.5% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.7% over the last 30 days. Alnylam has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Monday, Aug. 3, 2026 at 8:30 a.m. ET Chief Communications Officer - Jenna Bosco Chairman and Chief Executive Officer - Michael Weiss Chief Commercial Officer - Adam Waldman Chief Financial Officer - Sean Power Need a quote from a Motley Fool analyst? Email [email protected] Operator: Greetings. Welcome to TG Therapeutics Second Quarter Conference Call. [Operator Instructions] 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: Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and 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; and Sean Power, our Chief Financial Officer. Following our safe harbor statement, Mike will begin with an overview of our recent corporate developments. Adam will provide an update on our commercial efforts, and Sean will review our financial results before we open the call for Q&A. Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may include expectations regarding our future operating and financial performance, including sales trends, revenue guidance, projected milestones development plans and outlook for our marketed products and pipeline products. 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, and we disclaim any obligation to update or revise them. As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our website at www.tgtherapeutics.com. With that, I will turn the call over to Mike Weiss, our CEO. Michael Weiss: Thank you, Jenna, and 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. But 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 and 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. New patient starts continue to grow, physician adoption expanded and our commercial organization continued to execute at an exceptionally high level. As we approach $1 billion 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 #1 prescribed anti-CD20 therapy in relapsing MS based on dynamic market share, and 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 1 and day 15 initiation schedule. Based on feedback from health care 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. 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. And 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% to 65% of the overall anti-CD20 market. A successful subcu BRIUMVI will 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. And 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. 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. We're looking forward to sharing a clinical update during the second half 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, also advancing our pipeline and pursuing strategic business development opportunities that strengthen our long-term vision and generate attractive returns as well as 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: 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. And 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. And that's exactly what we're seeing in our business today with another excellent quarter. 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're raising our full year U.S. BRIUMVI net revenue guidance to $890 million to $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 $1 billion annualized revenue run rate and setting the stage for our first $1 billion-plus U.S. BRIUMVI revenue year in 2027. Building a blockbuster brand in less than 4 years doesn't happen by accident. It's the result of disciplined execution and relentless focus on the fundamentals that matter most. Over the past several years, we've 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've also been encouraged by the early response to our direct-to-consumer campaign and plan to expand those efforts during the second half of the year. We believe increasing patient awareness complements the commercial infrastructure we've built and represents another important driver of long-term growth. As the business continues to grow, we're able to leverage that commercial platform across an expanding franchise, creating increasing operating leverage over time. Looking ahead, we see 2 important opportunities to build on our MS franchise. The first is the new simplified IV initiation schedule supported by the positive ENHANCE Phase III results. If approved, initiating patients with a 600-milligram 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% to 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. But the more important point is how we think about these opportunities together. While they are 2 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's 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. 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. So when I look at the business today, I don't see just another strong quarter. I see a commercial franchise that's becoming stronger, expanding its patient base, deepening physician adoption, demonstrating strong persistence and creating increasing operating leverage. That's why 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: 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. 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. 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, cash equivalents and investment securities. On revenue guidance, U.S. BRIUMVI net revenue through the first half was approximately $423 million, on track for our full year target of $890 million to $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 to $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. And 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: [Operator Instructions] And our first question today comes from the line of Tara Bancroft with TD Cowen. Gregory Wiessner: This is Greg Torres on for Tara. So 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 2-month regimen? Michael Weiss: Thanks for the question. Adam, do you want to take that one? Adam Waldman: Yes. I mean we haven't given -- thanks for the question, Greg. We haven't given specific guidance on that in terms of revenue. But in general, we do think a less frequent dose is going to be better than a more frequent dose. . Operator: The next question is from the line of Prakhar Agrawal with Cantor Fitzgerald. Prakhar Agrawal: Congrats on the quarter. Maybe firstly, on the subcu BRIUMVI, since this would 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? And any sort of initial comments on how do you think the uptake will be given the brand familiarity here? And 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? And then 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. 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? And just to clarify if the sales to Neuraxpharm is done at a cost plus some markup on the revenue line item. Michael Weiss: Prakhar, thank you for that 5-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: Sure. Yes. Thanks for the question, Prakhar. On the subcu side, we're not going to talk about pricing yet. We still got a little bit of time here. We'll do the work that we need to do. But 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. But the profile that we have in mind, we think we'll do quite well in this space. Michael Weiss: Yes. I'll just layer on top of that. Adam and the team are to do proper market research. I do my own work when I go out in the field. I've been out in the field probably 6 or 7 days in the last 21 days, meeting with clinicians at primarily academic, large academic centers. And I can tell you the enthusiasm and excitement for the subcu product is pretty incredible, actually, pretty impressive. Particularly, it's really interesting. There's -- most of the people have heard about what we're doing. So the pretty educated teams have been out there. They see the data online and wherever. But the people who haven't yet realized that we're targeting a quarterly product that's in an auto-injector, their eyes light up. They've -- I think everyone is somehow thinking that you can't do this kind of a thing with taking an IV to a subcu. And it's really interesting to see how excited they get. So like I said, Adam is doing the market research on the uptake properly. But I can tell you, anecdotally, in the field when I talk to folks, they're pretty enthusiastic about it. And 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 2 of your question, OpEx drivers, slightly guidance, a little higher on the OpEx for the year. Sean, do you want to take a crack at the distribution there, R&D, SG&A. And Prakhar, to your point, yes, we've expanded R&D, but we're also -- I'll layer in and then, Sean, you can add a top. We've also -- 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. So I think you'll see some of that showing up. But Sean, maybe what else can you add to that? Sean Power: Yes. I think you covered it on the SG&A side, Mike. And of course, Prakhar, as you know, we call out the $100 million in subcutaneous manufacturing, secondary source manufacturing costs as well. So we factored that into overall guidance as well. But I think the combination of those 2 things should cover it. I think your last question was on NXP ex U.S. revenue for the rest of the year. So we do model in some continued product revenue, as you noted, that we've seen throughout the first half of the year. And then there is some other, of course, license and milestone related revenue that we model in for the remainder of the year, which drives that overall global revenue guide. Michael Weiss: Yes, I'll just layer on top. They are moving along pretty well on driving revenues. And so royalties are picking up a bit. But yes, in the second half, it's probably more related to milestones and other payments at the lowest. Operator: Our next questions are from the line of Michael DiFiore with Evercore ISI. Michael DiFiore: Two for me. Roche recently said that anti-CD20 competition was running above expectations and moved OCREVUS growth to the end of its range 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? And my second question is related to the schizophrenia study. What result would you consider strong enough to justify a larger randomized study? And yes, I'll just leave it there. Michael Weiss: Sure. Thanks. So Adam, maybe you can 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: Sure. Yes. Thanks for the question. Listen, we've -- 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, 2 record quarters in a row. So we continue to grow through the increased competition. And in terms of your question of where we're seeing it, we're seeing it from both switches from OCREVUS and treatment-naive patients. And 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. And then importantly, from switching from OCREVUS, we do know they're encouraging switches from their IV version to their subcu version. But despite that, we're still continuing to see strength in patients switching over to -- from OCREVUS to BRIUMVI. And we do see, I think, a lot of their business is coming from that switching as opposed to coming from BRIUMVI itself. Michael Weiss: Yes. Thank you, Adam, for that. I appreciate that. In terms of schizophrenia and the results that we would like to see to move on to Phase III. So Michael, the study is designed, we took a page out of our old oncology playbook. So it's designed as a Fleming 2-stage design. So 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 PAS response. And we compare those 2 in 2 steps to see if you can sort of reach the hurdle. If we reach the hurdle rate of responders, again, as it's designed is set up against a historical placebo rate. You've got to get above a certain hurdle, then I think we'd be pretty confident to move forward. 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. And 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, that Fleming 2-stage design on that and confirm that, that is predictive or not. But 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. So we'll keep you posted. But the idea is we'll get the response rate that we're expecting from the broader population that we're studying. We'll use -- again, we're doing the bio analysis to check and see what else is possible and what we can learn from it. But the main driver is going to be the response rate that we get. Operator: The next questions are from the line of Emily Bodnar with H.C. Wainwright. Emily Bodnar: I guess 2 for me as well. It looks like in the second quarter, a majority of growth in the MS market is kind of coming from the subcutaneous side. So I'm curious as you kind of advance and eventually commercialize BRIUMVI-based subcutaneous, how you see the IV market growing past that point? And then secondly, you mentioned you started some new indications for the azer-cel trial besides MS. Can you clarify which those are. Michael Weiss: Sure. Adam, do you want to talk about subcu growth over time and how that impacts IV growth in the future. Adam Waldman: Sure. I mean, look, we -- our plan is to give people a choice given we'll have an option in both markets. We believe these are fundamentally 2 different markets, a physician-administered market and a self-administered market. And today, we compete in the IV space and the subcu will provide us the opportunity to expand into the self-administered market. So -- and that will substantially increase our market. Strategically, we think about it as one BRIUMVI franchise. And I think different patients will have different preferences for route of administration. But our objective is to have a compelling BRIUMVI option regardless of which approach best fits in individual patients, which allows us, obviously, to compete across the entire RMS space with one trusted brand win and all the things that I said. And we think that's a significant competitive advantage for the franchise overall. Michael Weiss: Yes. 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, and we want to make sure everyone has a BRIUMVI option. But 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%. And we don't know if it's going to break out and become something different over time. But 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. Operator: The next question is from the line of Brian Cheng with JPMorgan. Lut Ming Cheng: Congrats on the quarter. Maybe just first, can you give us a bit more color around your updated U.S. net product revenue guidance? How is the raise reflective of your latest thinking of the IV uptick for the rest of the year? And then secondly, on MG, it would be great to hear how you're thinking about the opportunity here based on the post-Asgard induction setting that you're aiming for in the trial. What are some of the patient characteristics that you expect to capture in the study that may ultimately differentiate yourself from other historical MG trials? Michael Weiss: Thank you. Adam, do you want to take a crack at the first part of that question on the guidance. Adam Waldman: Sure. Yes. First of all, we're excited about the second half 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 second half is exactly how we outlined it in our prepared remarks. We continue to expect the fourth quarter to be the driver of the second half growth. And again, we've raised the annual guidance here based on the strength of what we've seen in the first half 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: Yes. And then 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-plus million. So we're going to continue to drive, and we're looking forward to our end of year coming out of the exit velocity of $1 billion run rate, which we think is pretty impressive. And I know Adam discussed it in his script, so I won't say more about that. On the MG and how we're thinking about it, MG is becoming a better served marketplace. But if you look at how the treatments are delivered today, it's -- look, 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. And then you wait and let the symptoms come back and then you treat again. And 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. But 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. And you put the 2 pieces together and hopefully, you have a treatment that is really tailor-made for this kind of a population, get them into a symptomatic remission quickly, keep them there by using BRIUMVI, whether it's every 6 months or quarterly. I think quarterly will be a really nice option for patients to be able to do it at home and really would simplify, I believe, the treatment burden. So yes, we think there's room for improvement. And any time there's room for improvement, there's an opportunity. Operator: The next question is from the line of William Wood with B. Riley Securities. William Wood: 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. So how should we think about what may be driving that third quarter decrease or flatness maybe seasonality or gross to net or potentially channel changes? And then 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 subcu coming to market. Michael Weiss: Yes. I'll lead off with the second half of that question. I'll let Adam take some part of that first question. But obviously, we haven't given guidance yet for 2027. So we'll do that hopefully early next year as we've done in past years. But we're certainly feeling good about where we're heading. And in terms of the overall franchise, look, we think that we have multiple pieces that will continue to drive growth. We've got next year, ideally, we'll have ENHANCE with the consolidated dosing, which should hopefully give us another growth expansion. And then sub-cu is an order of magnitude change, right? We're talking about something that is upsize comparable to the current market, if not larger than the current market that we're currently serving. And the current market we're serving, we're not even close in our belief to full saturation of our market share. So '27, 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. And then once we get into '28 subcu, it's a whole another ball game. So 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: Sure. Yes. I mean, listen, we've talked about this before on the call. And 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. It's simply too early in the quarter to know exactly how it would land. I think what we have greater visibility and confidence is the second half in aggregate, and 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 just -- we're more focused on the full year guidance. And as I said, I think the best way to think about the second half is how we outlined it, where we continue to expect fourth quarter to be the driver of the second half growth. Operator: The next question is from the line of Cha Yang with Jefferies. Cha Cha Yang: This is Cha on for Roger. Congrats on another great quarter. I have 2 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? And then two is, you talked about persistence being longer than you expected, whether you can talk more about what's driving that. Michael Weiss: Sure. Adam, I think this is all you. Go ahead. Adam Waldman: Yes, sure. Thanks for the question, Cha. As I said in my remarks, I think the response 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 omnichannel presence across digital, linear television, connected television, social channels and sort of putting a full complement of assets in the market. And again, we're excited about it and the leading indicators so far give us the confidence to continue to do that. And then as far as your question on persistence, yes, I mean, 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. So we think it's a sign of confidence in BRIUMVI, and we'll continue to track it. We're still relatively early in the life cycle of this brand. But so far, we're very, very encouraged by the persistence trends that we continue to see. Operator: Our next question is from the line of Prakhar Agrawal with Cantor Fitzgerald. Prakhar Agrawal: I had a lot of questions this quarter, Mike. Firstly, on gross to net, if you can just comment on the gross to 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 gross to net for the rest of the year? And secondly, we are seeing some consolidation happening in the mid-cap biotech space. You have predictability around cash flows, especially meaningful cash flow starting next year. What's the appetite for doing something meaningful on the BD front? Or are you looking at opportunities more on the earlier side. Michael Weiss: Thanks, Prakhar. Adam or Sean, do you want to talk about the GTM for the remainder of the year. Adam Waldman: Sure. Yes. Gross to net is basically unchanged from what we said. We predicted it to be in the mid-60s, and that prediction is still accurate. Michael Weiss: And 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. It's -- 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. And yes, 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. And we have patents out to the mid-2040s. So I think the durability of this franchise is far beyond what most people, I think, on the sell side are modeling today, and 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. One of the things we would 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. So 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'll be a lot of overlap between those 2. And then are there other mechanisms of action within those therapeutic areas that could be applied to satisfy the needs of that patient population. So that's I think we're thinking about it. But 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: 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: Great. Thank you, and thanks, everyone, for joining us. Just a quick summary on the 2Q progress. I think we did -- 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 autoimmunity-mediated diseases. We continue to advance azer-cel. And as you heard from Adam, we raised our guidance to $890 million to $905 million just in the U.S. alone and globally approaching $950 million. We continue to see BRIUMVI is a multibillion-dollar franchise in the making. I can't emphasize that enough. Creating value for our shareholders is our top priority. And BRIUMVI, as we said, becomes really the beginning of what we're working on to create value, becomes the lead of everything that we focus on. And finally, I 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 health care professionals continue to place their trust in us. We take that really seriously. So thanks again for that. And 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. Before you buy stock in TG Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and TG Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $399,832!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,374,595!* Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 10, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends TG Therapeutics. The Motley Fool has a disclosure policy. TG Therapeutics (TGTX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the strong quarter to record new patient starts and expanding physician adoption, positioning BRIUMVI as a foundational engine for long-term innovation. The company is shifting from a single-product focus to building a durable franchise, leveraging BRIUMVI's success to fund new formulations, indications, and novel therapeutic approaches like azer-cel. Positive Phase III ENHANCE data supports a simplified 600-milligram single-infusion initiation schedule, which management believes will remove barriers for patients switching from competing anti-CD20 therapies. Strategic positioning in the subcutaneous market is viewed as a material expansion, potentially doubling the addressable market by competing for the 35% to 40% of patients who prefer self-administered therapy. Operational leverage is improving as the company utilizes a single commercial infrastructure, reimbursement platform, and field team to support both IV and future subcutaneous offerings. Management emphasized azer-cel's expansion into multiple B-cell-mediated diseases, including progressive MS and MG, as a key pillar for future value creation beyond the core BRIUMVI franchise. Full-year 2026 U.S. BRIUMVI net revenue guidance was raised to $890 million to $905 million, with total global revenue now expected to reach approximately $950 million. Management expects the fourth quarter to be the primary driver of second-half growth, targeting a $1 billion annualized revenue run rate by the end of 2026. Top-line Phase III results for the subcutaneous ublituximab formulation are anticipated around year-end 2026 or early 2027, representing a critical catalyst for market share expansion. The company plans to lean into expanded direct-to-consumer (DTC) marketing efforts in the second half of 2026 to complement existing commercial infrastructure and drive patient awareness. Capital allocation remains focused on maximizing value per dollar, prioritizing BRIUMVI investments and strategic business development for single assets that complement the existing autoimmune portfolio. Reported $55 million in charges for the quarter related to subcutaneous and secondary source manufacturing activities, which are expensed as R&D but may provide future gross margin tailwinds. Underlying operating income, excluding one-time manufacturing charges, was approximately $76 million, which management identifies as a better reflection of the company's current earnings power. The company maintains a strong patent estate extending into the 2040s, providing a long-duration window for life cycle innovation and brand investment. Gross margins for the U.S. business remained consistent at approximately 87%, while total gross margin was 83% due to lower-margin sales to ex-U.S. partners. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that despite increased competition, BRIUMVI is seeing record growth from both OCREVUS switches and treatment-naive patients. They observed that competitors are encouraging switches from IV to their own subcu versions, yet BRIUMVI continues to capture share from the IV segment. Management declined to provide specific pricing but stated they intend to be competitive in the Part D market. Anecdotal feedback from large academic centers suggests high clinician enthusiasm for a quarterly auto-injector option compared to existing subcu therapies. The study uses a Fleming two-stage design to compare response rates against historical placebo data to quickly determine if a larger Phase III is justified. The initiative is a modest investment aimed at testing the hypothesis that a subset of schizophrenia patients has an underlying autoimmune component. The $25 million increase in global guidance is driven by a combination of growing royalties and anticipated milestone payments in the second half of the year. Supply sales to the partner are generally conducted at cost plus a markup, contributing to the overall global revenue mix.

Second quarter 2026 total global revenue of approximately $240 million, including BRIUMVI U.S. net product revenue of approximately $228 million Raises full year 2026 total global revenue target to approximately $950 million and raises full year 2026 BRIUMVI U.S. net product revenue target to approximately $890 - 905 million Conference call to be held today, Monday, August 3, 2026, at 8:30 AM ET NEW YORK, Aug. 03, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the second quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “The second quarter of 2026 was another strong quarter for TG Therapeutics. BRIUMVI delivered another outstanding commercial quarter, exceeding our expectations once again and putting us on track to exit 2026 at an approximately $1 billion annualized U.S. BRIUMVI revenue run rate. Mr. Weiss continued, “Beyond our commercial performance, we continued to expand the long-term opportunity for BRIUMVI with positive Phase 3 ENHANCE results supporting a simplified initiation regimen, encouraging progress in our subcutaneous BRIUMVI program, advancement into myasthenia gravis and schizophrenia, and continued momentum across our azer-cel cell therapy platform. As BRIUMVI continues to grow, it is becoming the foundation of a broader company focused on advancing innovative therapies for immune-mediated diseases. The progress we made this quarter reinforces our confidence in our strategy and our ability to create long-term value for both patients and shareholders.”Recent Highlights & Developments BRIUMVI® (ublituximab-xiiy) Commercialization BRIUMVI U.S. net product revenue of $227.7 million for the second quarter 2026, representing approximately a 64% increase over the same period last year Total global revenue of $240.3 million for the second quarter 2026 Subcutaneous BRIUMVI Announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab (the active agent in BRIUMVI) as compared to IV BRIUMVI Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial PK modeling and simulation informed by the Phase 1 bioavailability data support the quarterly subcutaneous dosing regimen that is being evaluated in the fully enrolled Phase 3 trial Top-line Phase 3 data is expected year-end 2026 or early 2027 Positive Topline Phase 3 ENHANCE Data Announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI in adults with RMS The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. BRIUMVI in Myasthenia Gravis Announced positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis (MG) Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG BRIUMVI in Schizophrenia Initiated a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia 2026 Financial Guidance Update Raises full year 2026 target total global revenue to approximately $950 million Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $890 - $905 million Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 - $400 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs 2026 Remaining Development Pipeline Anticipated Milestones Present full results from the Phase 3 ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026 Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027 Financial Results for Second Quarter 2026 Product Revenue, net: Product revenue, net was $235.8 million and $437.1 million for the three and six months ended June 30, 2026, respectively, compared to $138.8 million and $258.5 million for the three and six months ended June 30, 2025, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $227.7 million and $422.5 million during the three and six months ended June 30, 2026. Also included in product revenue, net for the three and six months ended June 30, 2026 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $8.1 million and $14.6 million, respectively. License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $4.5 million and $8.1 million for the three and six months ended June 30, 2026, respectively, compared to approximately $2.3 million and $3.5 million for the three and six months ended June 30, 2025. License, milestone, royalty and other revenue for the three and six months ended June 30, 2026 is predominantly comprised of $3.6 million and $6.3 million, respectively, of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm, and $0.9 million and $1.8 million, respectively, of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement. R&D Expenses: Total research and development (R&D) expense was approximately $95.3 million and $143.7 million for the three and six months ended June 30, 2026, compared to $31.8 million and $78.1 million for the three and six months ended June 30, 2025. During the three and six months ended June 30, 2026 we incurred approximately $54.6 million and $58.8 million, respectively related to subcutaneous manufacturing and secondary manufacturer expenses. The period over period increase in R&D was also attributable to higher clinical trial-related expenses associated with our development pipeline during the period. SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $82.1 million and $170.3 million for the three and six months ended June 30, 2026, compared to $55.6 million and $105.9 million for the three and six months ended June 30, 2025. The increase in selling, general and administrative costs during the three and six months ended June 30, 2026 was primarily due to an increase in marketing and media spend, and personnel costs associated with the commercialization of BRIUMVI. Net income: Net income was $7.8 million and $27.6 million for the three and six months ended June 30, 2026, respectively, compared to net income of $28.2 million and $33.2 million for the three and six months ended June 30, 2025. Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $612.3 million as of June 30, 2026. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan. CONFERENCE CALL INFORMATIONThe Company will host a conference call today, August 3, 2026, at 8:30 AM ET, to discuss the Company’s financial results from second quarter of 2026. To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for a period of 30 days after the call. ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IVBRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features. A list of authorized specialty distributors can be found at www.briumvi.com. IMPORTANT SAFETY INFORMATION Contraindications: BRIUMVI is contraindicated in patients with: Active Hepatitis B Virus infection A history of life-threatening infusion reaction to BRIUMVI WARNINGS AND PRECAUTIONS Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization. Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI. Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis. If PML is confirmed, treatment with BRIUMVI should be discontinued. Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted. Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose. Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration. Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury. Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI. Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com. ABOUT BRIUMVI PATIENT SUPPORT in the U.S.BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.ABOUT MULTIPLE SCLEROSISRelapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1 ABOUT TG THERAPEUTICSTG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.BRIUMVI® is a registered trademark of TG Therapeutics, Inc.Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy, and objectives for future operations may constitute forward-looking statements. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below. Such forward looking statements include but are not limited to statements regarding our plans, business strategies and operations related to the commercialization of BRIUMVI® (ublituximab-xiiy) for RMS in the United States, or any jurisdictions outside of the United States; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, or TG expenses or profit estimates or targets; our ability to execute our share repurchase program; expectations and timing for our clinical trials of subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes referred to as subcutaneous BRIUMVI; expectations and timing for our ENHANCE Phase 3 pivotal program to evaluate a consolidated day 1 and day 15 dosing regimen for IV BRIUMVI; and expectations and timing for any of our pipeline products or programs, including Azer-cel or BRIUMVI in MG. Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to continue to commercialize BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not be sustained during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variations from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2026 development pipeline anticipated milestones or goals in the timeframe projected or at all, including (i) completing a pivotal program for subcutaneous ublituximab, (ii) completing a pivotal program based on data from the ENHANCE trial to consolidate day 1 and day 15 dosing, (iii) enrolling patients into a trial evaluating BRIUMVI in MG or schizophrenia, or (iv) enrolling patients into a trial evaluating azer-cel; the risk that clinical trial data readouts may be delayed due to a number of factors including enrollment, data collection, data maturity or other factors; the risk that the subcutaneous Phase 3 program will not be successful or if successful still will not be approved by the FDA or achieve commercial acceptance; the risk that, if subcutaneous BRIUMVI is approved, the anticipated expansion of the addressable market will not be realized; the risk that the ENHANCE Phase 3 trial will not be successful or if successful will not be approved by the FDA or achieve commercial acceptance; the risk that we will not move forward with the development of BRIUMVI in MG or schizophrenia and azer-cel in progressive MS following preliminary studies; the uncertainties generally inherent in research and development and early stage exploratory programs; the risk that the collaboration with Christina Applegate is not able to be implemented or does not go as planned for regulatory or other reasons; the risk that the www.nextinms.com platform does not gain traction or ceases to exist; regulatory developments, legislative actions, executive orders, including the imposition of tariffs and policy changes in the U.S. and other jurisdictions; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.CONTACT: Investor RelationsEmail: [email protected]: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: [email protected]: 1.877.575.TGTX (8489), Option 6 1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Data monitor p. 236. * Condensed from audited financial statements

TG Therapeutics (TGTX) came out with quarterly earnings of $0.05 per share, missing the Zacks Consensus Estimate of $0.41 per share. This compares to earnings of $0.17 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -87.81%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.23 per share when it actually produced earnings of $0.17, delivering a surprise of -26.09%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $240.34 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 4.08%. This compares to year-ago revenues of $141.15 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have added about 74.5% since the beginning of the year versus the S&P 500's gain of 9.4%. While TG Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.38 on $246.15 million in revenues for the coming quarter and $1.45 on $947.92 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, ANI Pharmaceuticals (ANIP), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 7. This drugmaker is expected to post quarterly earnings of $2.01 per share in its upcoming report, which represents a year-over-year change of +11.7%. The consensus EPS estimate for the quarter has been revised 0.3% lower over the last 30 days to the current level. ANI Pharmaceuticals' revenues are expected to be $262.73 million, up 24.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

TG Therapeutics TGTX reported earnings of 5 cents per share for the second quarter of 2026, missing the Zacks Consensus Estimate of 41 cents. The company had reported earnings of 17 cents per share in the year-ago quarter. Total revenues in the second quarter were $240.3 million, up almost 70.3% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi (ublituximab-xiiy). The figure beat the Zacks Consensus Estimate of $231 million. Briumvi, an anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) in December 2022. The drug is also approved in the European Union, the United Kingdom, Australia, Switzerland and certain other countries. Shares of TG Therapeutics were down in pre-market trading on Aug. 3 following the announcement of the news. The stock has rallied 74.6% in the year-to-date period compared with the industry’s rise of 2.8%. Image Source: Zacks Investment Research The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $235.8 million in the reported quarter, reflecting a 69.9% year-over-year increase. Total product revenues included sales of Briumvi to TGTX’s licensing partner, in ex-U.S. markets, Neuraxpharm, of $8.1 million. TG Therapeutics has an agreement with Neuraxpharm Pharmaceuticals for the ex-U.S. commercialization of Briumvi, wherein the company is entitled to receive payments upon the achievement of certain commercial milestones and targets. Briumvi's net product sales in the United States were $227.7 million in the second quarter, up 64% year over year. Sales of the drug came in ahead of management’s guided range of $220 million. License, milestone, royalty and other revenues were $4.5 million in the second quarter, compared with $2.3 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding stock-based compensation) jumped 217.5% year over year to $87.3 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation) totaled $62.3 million, up 43.2% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of June 30, 2026, TG Therapeutics had cash, cash equivalents and investments worth $612.3 million compared with $572.8 million as of March 31, 2026. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $950 million in 2026, compared with the previous expectation of around $925 million. The company now expects net product revenues of $890-$905 million from Briumvi sales in the United States in 2026, up from the previous expectation of $885-$900 million. Excluding non-cash compensation, total operating expenses, defined as R&D and SG&A, are now expected to be around $350-$400 million in 2026, compared with the previous expectation of around $350 million. Several additional studies on Briumvi targeting other autoimmune diseases are currently ongoing. Last month, the company initiated a phase II study evaluating Briumvi for the treatment of adult patients with treatment-resistant schizophrenia. Per management, the study is expected to help determine whether B-cell depletion with Briumvi can improve symptoms in adult patients with treatment-resistant schizophrenia. The company recently initiated a phase II study to evaluate the efficacy and safety of Briumvi in maintaining clinical response in patients with myasthenia gravis who initially respond to treatment with the FcRn inhibitor, Vyvgart (efgartigimod). TG Therapeutics is developing a self-administered subcutaneous formulation of Briumvi for treating RMS in a pivotal phase III study. Top-line data from this study are expected to be announced by the end of 2026 or the first quarter of 2027. If successfully developed, the Briumvi SC formulation may eventually be available as a quick injection rather than a lengthy IV infusion, which could make treatment more convenient for patients. In May 2026, TG Therapeutics announced that the phase III ENHANCE study, which evaluated a consolidated single-infusion regimen of its sole marketed drug, Briumvi, in adult patients with relapsing forms of multiple sclerosis, has met its primary endpoint. TG Therapeutics is also developing azer-cel, an allogeneic CD19-directed CAR T cell therapy, in a phase I study for treating patients with primary progressive multiple sclerosis. Preliminary data from this study is expected to be presented in the second half of 2026. TG Therapeutics, Inc. price-consensus-eps-surprise-chart | TG Therapeutics, Inc. Quote TG Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.30, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have lost 5.9% year to date. Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 13.9% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 143.9% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in TG Therapeutics, Inc.? Here are five stocks we like better. Strong BRIUMVI growth lifted TG Therapeutics’ outlook: Second-quarter revenue reached $240 million, driven by $228 million in U.S. BRIUMVI sales, which rose 17% sequentially and more than 64% year over year. The company raised 2026 U.S. BRIUMVI guidance to $890 million–$905 million and global revenue guidance to approximately $950 million. New formulations could expand BRIUMVI’s market: Positive Phase III results support a potential single-infusion initiation schedule as early as mid-2027, while the company expects subcutaneous BRIUMVI results around year-end 2026 or early 2027. Profitability and pipeline advanced: TG Therapeutics reported $21.7 million in operating income, $7.8 million in net income and $612 million in cash and investments. Beyond multiple sclerosis, it expanded studies in myasthenia gravis and treatment-resistant schizophrenia and continued enrollment in its azer-cel CAR T program. The Most Shorted Stocks in June: Hold, Short, or Squeeze? TG Therapeutics (NASDAQ:TGTX) reported second-quarter 2026 revenue of $240 million and raised its full-year sales outlook for BRIUMVI, its treatment for relapsing multiple sclerosis, as the company cited record new patient starts, continued prescriber expansion and higher-than-expected treatment persistence. U.S. BRIUMVI net product revenue totaled approximately $228 million in the second quarter, up 17% sequentially and more than 64% from a year earlier, according to Chief Commercial Officer Adam Waldman. Total net product revenue was $236 million, including sales to the company’s ex-U.S. partner, while license, royalty and other revenue contributed $4.5 million. → Lost in Space: Why Aerospace Valuations Are Plummeting Right Now TG Therapeutics Stock 300% Rally Has Legs Yet The company increased its 2026 U.S. BRIUMVI net revenue guidance to $890 million to $905 million and said it now expects approximately $950 million in total global revenue for the year. TG Therapeutics said U.S. BRIUMVI net revenue was approximately $423 million through the first half of 2026, while total revenue reached about $445 million. Waldman said the second quarter marked another record for BRIUMVI new patient starts, surpassing the prior record set during the first quarter. The company also reported continued growth in repeat prescribers and said a rising share of patients are beginning treatment with BRIUMVI rather than switching to it later. → MarketBeat Week in Review – 07/27- 07/31 “Persistence continues to exceed our expectations,” Waldman said, adding that the company is seeing growth from both patients switching from OCREVUS and treatment-naive patients. He said treatment-naive starts indicate growing physician confidence in the brand. TG Therapeutics expects the fourth quarter to account for much of its second-half growth and said it aims to exit 2026 with quarterly U.S. net revenue above $250 million, representing a $1 billion annualized revenue run rate. The company did not provide 2027 guidance, though management said it expects continued franchise growth opportunities from a simplified intravenous initiation regimen and a potential subcutaneous formulation. → GE HealthCare Stock Climbs on Vital Diagnostics Demand Management said it has begun to expand its direct-to-consumer efforts after seeing positive early indicators from its initial campaign. Waldman said the broader campaign is expected to include digital, linear television, connected television and social media channels. During the quarter, TG Therapeutics reported positive top-line Phase III results from the ENHANCE study evaluating a single 600-milligram BRIUMVI infusion to initiate treatment. The proposed schedule would replace the currently approved initiation regimen involving infusions on day one and day 15. Chief Executive Officer Michael Weiss said a single-infusion initiation could reduce the treatment burden for patients and infusion centers and remove a barrier for patients switching from another anti-CD20 therapy. If approved, the revised initiation schedule could become available as early as mid-2027, according to management. The company also reported positive Phase I bioavailability data for its proprietary subcutaneous formulation of ublituximab, the active agent in BRIUMVI. Its Phase III subcutaneous BRIUMVI study is fully enrolled, with top-line results expected around year-end or early 2027. TG Therapeutics currently participates in the physician-administered segment of the anti-CD20 market, which management estimated represents roughly 60% to 65% of the overall market. Waldman said self-administered products account for approximately 35% to 40% of the dynamic anti-CD20 market. The company believes a successful subcutaneous formulation would enable BRIUMVI to compete across both segments. Management did not disclose prospective pricing for subcutaneous BRIUMVI, but Waldman said the company believes it can price the product competitively. He also said the company views less frequent dosing as preferable to a more frequent regimen. TG Therapeutics is also studying BRIUMVI in other autoimmune-mediated conditions. The company announced preliminary Phase I data in myasthenia gravis and initiated what Weiss described as a potentially registration-directed Phase II study. The program is evaluating an approach that combines rapid symptom relief from FcRn inhibition with potentially longer-term disease control from BRIUMVI. The company also initiated a Phase II study in treatment-resistant schizophrenia. Weiss said the trial will assess clinical outcomes and biomarkers intended to identify whether some patients have an autoimmune component to their disease. The study uses a Fleming two-stage design, with advancement decisions expected to depend primarily on the observed response rate and potentially on biomarker findings. Separately, TG Therapeutics said its allogeneic CD19 CAR T-cell program, azer-cel, has enrolled more than 20 patients, primarily with progressive forms of multiple sclerosis. The study has expanded to include relapsing MS, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and neuromyelitis optica. The company expects to provide a clinical update in the second half of 2026. Chief Financial Officer Sean Power said the company’s U.S. gross margin was approximately 87% during the quarter, while total gross margin was 83% after including ex-U.S. partner sales and other revenue sources. Operating expenses, excluding stock-based compensation, were approximately $150 million. That amount included roughly $55 million of expenses tied to subcutaneous and secondary-source manufacturing activities. Excluding those charges, underlying operating expenses were about $95 million, Power said. TG Therapeutics reported operating income of $21.7 million and net income of $7.8 million, or $0.05 per diluted share. Excluding the manufacturing-related charges, the company said operating income would have been approximately $76 million and net income approximately $62 million. The company ended the quarter with approximately $612 million in cash equivalents and investment securities. It expects 2026 operating expenses, excluding stock-based compensation, of $350 million to $400 million, plus approximately $100 million in manufacturing-related expenses. TG Therapeutics, Inc 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "TG Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.