TG Therapeutics, Inc. 2026 Q2 Earnings Call

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

Please note that these statements are subject to risks and uncertainties that can cause our actual results to differ materially from those indicated. These risks are detailed in our SEC filings. Additionally, any forward-looking statements made today reflect our views only as of this date, we disclaim any obligation to update or revise them. As a reminder, this conference call is being recorded and will be available for replay for the next 30 days on our website at www.tgtherapeutics.com. With that, I will turn the call over to Mike Weiss, our CEO.

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

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

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

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

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.

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

Adam, please go ahead. Thanks, Mike, and good morning, everyone.

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

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