TG Therapeutics, Inc. (TGTX) Q1 2026 Earnings Report, Transcript and Summary

Greetings, and welcome to the TG Therapeutics First Quarter Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Jenna Bosco, Chief Communications Officer. Thank you. You may begin.

Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' First 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'd 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 our 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'll now turn the call over to Mike Weiss, our CEO.

Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone, but because of the consistency and durability we're now seeing across the business. Let me start with the commercial side. At a high level, Q1 was a record-setting quarter across nearly every metric we track. The momentum puts us in a very strong position as we move through the rest of the year. From a revenue standpoint, we delivered approximately $195 million in U.S. BRIUMVI net product revenue in quarter 1, ahead of our guidance of $185 million to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone. And as we move toward $1 billion annualized run rate expected before year-end, we continue to believe we are still early in the BRIUMVI adoption curve, making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today. Physicians are increasingly recognizing the value of BRIUMVI, not just on efficacy, but on the overall treatment experience, thus translating into durable, repeatable growth. And importantly, the data continues to support that differentiation. Earlier this year, we were pleased to see our 5-year follow-up data from the ULTIMATE I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BRIUMVI along with a consistent safety and tolerability profile over time. At AAN earlier this month, we continue to build on that story with real-world data demonstrating sustained and rapid B-cell depletion, low annualized relapse rates maintained over time and continued evidence of a favorable infusion experience and tolerability profile. And for the first time, we presented prospective data from patients who switched from a prior anti-CD20 therapy to BRIUMVI, which showed improvement in patient-reported wearing off symptoms, sometimes referred to as the clot gap after switching to BRIUMVI. Given that meaningful number of patients report this wearing off effect, the potential to address it represents a clear and differentiated use case. Turning to the pipeline. This is where we continue to invest in both strengthen and extend the franchise. First, our Phase III ENHANCE study, evaluating initiation of BRIUMVI therapy with a single 600-milligram IV infusion as compared to the currently approved schedule of 600 milligrams divided into two infusions, on day 1 and on day 15. I'm pleased to report that based on current time lines, we expect top line data from this Phase III study in the coming weeks. Assuming a positive outcome and regulatory approval, we believe this positions us to launch the consolidated dosing schedule next year. This is about simplicity, fewer infusions, same efficacy. And feedback on eliminating the day 15 infusion continues to be very positive from both patients and providers. Now turning to our subcutaneous program. We are developing a self-administered at-home version of BRIUMVI, expected to be delivered via an auto-injector and a pen-like device. This program is designed to expand optionality and importantly, expand the number of patients we can reach. The program began with a Phase I dose escalation bioavailability study, evaluating subcu dosing relative to our approved IV schedule. Based on encouraging preliminary results, we advanced directly into our Phase III program. In Phase III, we are evaluating 2 subcu dosing schedules, every 2 months and quarterly dosing with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks. We are pleased to report in April that the study is now fully enrolled, and we expect top line data around year-end or early next year, putting us on track for a potential 2028 launch of subcu BRIUMVI, assuming a positive outcome and regulatory approval. And I know many of you have been waiting for the Phase I bioavailability data. We now expect to share those results in the coming weeks. Strategically, it's important to understand what subcu represents. This is not about incremental growth, and it's not about building a new infrastructure or entering a new indication. This is about expanding our reach within the same disease with largely the same physicians and commercial footprint, creating significant operating leverage. By enabling us to compete across both infusion and self-administered settings, we move from participating in a portion of the market to potentially participating across the entire anti-CD20 landscape. And as a result, we believe this has the potential to nearly double our addressable market with relatively limited incremental operating expense. Beyond relapsing MS, we are expanding the reach of BRIUMVI in additional autoimmune indications. We view BRIUMVI as a pipeline within a product with a long runway supported by patent protection into the 2040s. Myasthenia Gravis, we've completed our Phase I work and expect to initiate a Phase II potentially registration-directed study this quarter. We're also initiating an exploratory study in treatment-resistant schizophrenia. There is emerging evidence suggesting an autoimmune component in a subset of these patients. It's early, but have validated the implications could be significant. And finally, azer-cel, our allogeneic anti-CD19 CAR-T continues to advance in progressive MS. Importantly, trial sites are identifying more patients than we currently have slots available and additional sites continue to express interest in participating. This further highlights the unmet medical need in progressive MS. We look forward to sharing updates from this study later this year. Finally, I'd like to make a few remarks on our capital allocation. During the quarter, we expanded our relationship with Blue Owl, enhancing our financial flexibility. This gives us the ability to continue repurchasing shares and pursue strategic business development opportunities. We've been clear. We view our stock as undervalued, and we're acting on that. This quarter alone, we repurchased $100 million of our stock. At the same time, our approach to capital allocation is straightforward. We will continue to deploy capital where we see the best risk-adjusted long-term return, whether that's in the business, repurchasing shares or pursuing external opportunities or investments. With that, let me turn the call over to Adam Waldman, our Chief Commercialization Officer, for more detailed commercial update. Adam, please go ahead.

Thanks, Mike, and good morning, everyone. I'll pick up on a few themes that Mike just laid out, particularly around consistency, durability and execution because that's exactly what we're seeing on the commercial side of the business. We delivered approximately $195 million in U.S. net revenue in Q1, exceeding our guidance range and growing 63% year-over-year, our 12th consecutive quarter of sequential growth since launch. We saw record new patient enrollments in the quarter, and March was our highest month ever. As a result of the strong first quarter, we're raising full year U.S. revenue guidance to $885 million to $900 million, and we're providing Q2 guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. And importantly, we've now reached a meaningful milestone. More than 25,000 patients have been prescribed BRIUMVI globally. That's important because at this point, we're no longer talking about early adoption. We're talking about a growing installed base of patients being treated in the real world. At its core, this is a recurring treatment model. Patients who start BRIUMVI are typically treated every 6 months, and we continue to see strong persistence over time, stronger than what we originally modeled. That means our revenue base doesn't reset each year, it builds. Each cohort of new patients adds to an expanding base of recurring demand. As that base grows, we're developing greater visibility into underlying demand and growth becomes more predictable over time. The outperformance we saw in Q1 and the raise in guidance reflects both that growing base, including better-than-expected persistence and stronger-than-expected new patient demand. Importantly, we guide conservatively on that new patient growth layer, and we raise when the data supports it. That combination is what's driving the business today. And as we said before, the more patients that go on BRIUMVI, the more patients will go on BRIUMVI, and we're seeing that dynamic take hold. Let me be direct about the competitive environment. We compete against established products backed by large organizations, and we don't underestimate that. At the same time, in Q1, we continued to grow sequentially while outpacing both competitors and the broader MS market. We've been growing IV share consistently, and we're now the #1 CD20 by dynamic share in private practices with infusion capabilities. Why is that happening? Because we're delivering on the factors that matter most to physicians, a compelling clinical profile, operational simplicity and a consistent treatment experience. The 1-hour infusion, twice yearly dosing and long-term data all contribute to that. And when physicians put a patient on BRIUMVI and that patient has a positive outcome, that physician becomes a repeat prescriber. Since November, we've seen consistent increases in total monthly prescribers with March setting a new high. And most importantly, we're increasing uptake with treatment-naive patients, patients starting their CD20 journey on BRIUMVI, not switching to it. The share of naive patients in our mix continues to rise, which we view as the strongest leading indicator of long-term market position. The momentum we're seeing comes down to execution and doing a few things consistently well. We've reduced friction across the treatment journey, improving time to start and conversion rates. We've expanded our reach and deepened our presence across accounts. And our DTC efforts are helping to increase patient awareness with more patients entering the office already informed about BRIUMVI. This is exactly what we set out to build, a commercial engine that can deliver consistent execution, support long-term growth and scale over time. And importantly, we're doing this while still early in the life cycle. As Mike outlined, we have two programs that help explain why we believe the long-term opportunity is meaningfully larger than what is reflected today. First, ENHANCE. This is about simplifying the initiation process by eliminating the day 15 infusion. If successful, we would expect it to enhance operational efficiency and make it easier for physicians and infusion centers to get patients started on BRIUMVI. We view this as an incremental improvement to an already strong IV offering, one that can further support adoption. Second, our subcutaneous patient administered formulation. This is a much more significant strategic opportunity. Today, the subcutaneous patient-administered segment represents roughly 35% of the anti-CD20 market, a segment we are not participating in today. So this is not about taking share within our existing IV business. This is about opening up a new segment of the market. If successful, subcu BRIUMVI would allow us to reach patients who prefer or require at-home self-administration, compete directly in a large and growing segment of the market and meaningfully expand the overall addressable opportunity. And when you look at this holistically, IV plus subcu is not just incremental expansion. It has the potential to redefine the scale of the BRIUMVI franchise over time. Importantly, the current business is already performing at a high level. We don't need these programs to deliver on our near-term expectations. But over time, they have the potential to meaningfully expand both the reach and long-term value of BRIUMVI. So to summarize, we've outperformed expectations in Q1, driven by strong underlying demand. We're seeing continued expansion in both patients and prescribers. Our execution is translating into durable, increasingly predictable growth, and we're significantly raising our 2026 outlook. We now have over 25,000 patients globally, and that base continues to grow. We're approaching a $1 billion annualized run rate, supported by a model that is becoming more scalable over time. And with IV and subcu, we're building a franchise that has the potential to compete across the full spectrum of the anti-CD20 market. When you consider the size of the IV market, the portion we'll be able to access with subcutaneous and the trajectory we're seeing today, we believe the long-term opportunity for BRIUMVI is well above where consensus peak estimate sales sit today and ultimately more consistent with the leading assets in the category. Let me now turn the call over to Sean Power, our CFO, for a detailed financial update.

Thanks, Adam. A few things to highlight on the financial side. As Mike and Adam highlighted, we came in ahead of expectations. U.S. net product revenue in Q1 was approximately $195 million, up 63% versus the same quarter last year. Total net product revenue was $201 million when including product sales to Neuroxpharm, our ex-U.S. partner. Add in $3.6 million of license, royalty and other revenue and total revenue for the quarter was $205 million. On the expense side, OpEx, which we define as R&D and SG&A, excluding stock-based comp, was approximately $117 million for the quarter. That year-over-year increase reflects continued investment across the business. On the R&D side, a milestone expense under our Precision Biosciences agreement and higher clinical costs, partially offset by lower subcutaneous manufacturing and development spend. And on the SG&A side, expanded marketing and media investment supporting BRIUMVI's continued growth. Even with that investment, revenue growth continues to outpace expense growth, and that dynamic drove operating income of $34.8 million compared to $8.6 million in Q1 of last year. One item worth flagging below the operating line was a onetime $9.2 million charge related to the refinancing of our Blue Owl facility, of which approximately 50% was noncash. All that nets to net income for the quarter of $19.8 million or $0.12 per diluted share compared to $5.1 million or $0.03 per diluted share a year ago. On the balance sheet, we ended the quarter with approximately $573 million in cash, cash equivalents and investment securities, up from roughly $200 million at year-end, reflecting primarily the proceeds from the expanded Blue Owl facility. From a capital allocation standpoint, we repurchased over 3 million shares during the quarter at an average price of roughly $30. Since launching the program, we bought back approximately 6.8 million shares at an average price of approximately $29, nearly 5% of shares outstanding, leaving us with 153 million shares outstanding today. Turning to guidance. We're raising our full year total global revenue guidance to approximately $925 million. On expenses, we continue to expect full year operating costs of approximately $350 million, excluding stock-based comp, plus approximately $100 million for subcutaneous manufacturing and secondary manufacturer start-up activities. As we've noted previously, those manufacturing costs are expensed through R&D as incurred. So if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods. All in all, it was a strong quarter. Revenue ahead of expectations, operating income up meaningfully year-over-year and a balance sheet that gives us real flexibility going forward. With that, I'll turn the call back over to the conference operator to begin the Q&A.

[Operator Instructions] First question comes from Corinne Johnson with Goldman Sachs.

Maybe could you just speak to the market opportunity for the subcutaneous product? If you're able to bring a 12-week versus 8-week formulation to the market, do you see that as going to meaningfully different in terms of your ability to gain share in that currently untapped population?

Sure. Adam, do you want to tackle that one?

Sure. Yes. Thanks for the question, Corinne. As we mentioned, that segment represents about 35% of the CD20 market today. One, we do not compete in. And our perspective is this is expanding into a new patient population rather than shifting patients within our existing base. We think of these as largely distinct segments with different patients and physician preferences. And importantly, I think, as Mike mentioned, puts us in position to compete across both the IV and subcu space across the entire CD20 landscape. We think that Q3 -- to your question about dosing, we think Q3 obviously would be better than incrementally better. I think both are going to be great. But I think we subscribe to less is more. But I think both would be a very strong profile, and we feel good about the opportunity for both whichever way it works out.

Next question, Brian Cheng with JPMorgan.

Just first, can you talk a little bit about the cadence of data from the ENHANCE trial and the Phase I bioavailability data? In your prepared remarks, you said both data will be coming in the coming weeks. So which one should we expect first? Are both data coming at the same time? And I have a follow-up.

Yes. In terms of timing, we don't have the exact timing. We just know that things are coming in soon. So we just basically thought we'd let people know that, that data was coming.

Okay. Earlier during you talked about the dynamics of persistence, and you talked about how persistence is stronger than you have anticipated. Can you provide a little bit more color to that? And how much does the DTC campaign so far in driving patients coming to physician practice and asking for BRIUMVI?

Thanks for the question, Brian. Adam, do you want to tackle this one?

Sure. I mean on the persistent side, obviously, we're encouraged, given my remarks, we're encouraged by what we're seeing on the persistence, particularly as patients move into the second year of treatment where trends have been better than expected. And we think these patterns that we're seeing are supportive of the durability of the patient experience, which obviously reflects the tolerability and efficacy of BRIUMVI. That said, still early, and we will continue to monitor it, but we're growing in confidence as we continue to build as the data matures. And it comes down to sustainability of efficacy and tolerability. And then generally, when patients do well, they stay on therapy and that drives persistence. As far as DTC, we're encouraged. We've been putting effort into DTC over the last year or so. We've been encouraged with the markers and indicators of success. We'll continue to invest in the space. We think this is a patient driven. They do have shared decision-making in this market. And so we're going to continue to focus on it, and we are encouraged by what we're seeing so far.

Next question, Tara Bancroft with TD Cowen.

This is Greg on for Tara. So you reiterated top line Phase III data for the subcu BRIUMVI around year-end 2026 or early next year. Can you provide any additional color on the cadence from data readout to filing? And how quickly the subcu formulation become commercially available, assuming a favorable outcome?

Sure. So our target is to have the subcu available sometime in 2028. In terms of the cadence of filing after the completion of that study, our goal is to get that filed as soon as we can. We've got a few other studies we'll need to do in the interim to get the filing package complete, including the bridge to the auto-injector. But yes, I mean, for '28, as soon as early as possible, '27, we're going to get that filing done. That's the goal for '28 approval. Again, it's -- the one thing we can't control is the -- about a 12-month review process. So that's the timing of that. Was there a last part of that question, I'm sorry. No, that covers my question.

Next question, Roger Song with Jefferies.

This is Cha Cha Yang on for Roger. So I was wondering if you could speak to what you think the impact of remibrutinib's potential approval in MS would be on BRIUMVI, but also on the CD20 class as a whole?

Yes. Thanks for the question. So we continue to await product profiles for all the BTKs as they've come through the clinical trials. Each one in turn has had some difficulties, I would say, in producing data that is convincing of a clinical benefit over risk. We'll see how fenebrutinib does at the agency and remibrutinib is yet to come. So I think we just have to wait. I mean, overall, we've maintained our position that there's certainly a home for these drugs in certain patient populations, particularly patients who are potentially secondary -- nonactive secondary progressive where we're not labeled. So I think there's room for -- remember, there's still a big oral market. I think there's room for a BTK with the right profile to participate in that oral marketplace. But we don't think it's a drug class that will have a material impact on the CD20 class.

Next question, Michael DiFiore with Evercore ISI.

Just one for me. Just given Roche's potential twice yearly home OCREVUS device and KESIMPTA's longer interval work, what dosing profile does subcu guy need to have in order to be meaningfully differentiated? Is every 2-month dosing enough? Or is quarterly dosing really the commercial bar given where we're headed?

Sure. Thanks for the question, Michael. Look, as Adam mentioned, it's a competitive market. Everyone is trying to do their best to improve their product profile to meet the needs and challenges that these individuals with MS face, and we're certainly doing our part. Obviously, we've said before, we feel that -- and Adam said it earlier, the market is large. It can probably get larger on the subcu side. We'll continue to obviously have a very big presence in the IV sector, whereas I don't think the other -- I don't think OCREVUS' long-term plan is to participate much longer in the IV marketplace. And as you mentioned, they're working on their own at-home on-body device. So like I said, from the standpoint of the patient, this is all great. And as Adam mentioned earlier, every two months or every three months will be a really strong offering. Again, it's BRIUMVI still loaded into the auto-injector, which means that all the differentiation that we have on the IV side, on the molecule itself will continue to exist as we go into the marketing effort on the subcu side. So convenience is one thing. Obviously, as Adam said, quarterly is going to be incrementally better than every other month. We feel obviously very confident in our ability to deliver a quarterly product, but I think we'll let the data speak for itself as it solely comes out. But yes, I think we're going to do great. I mean we've done quite well in the IV space. Again, BRIUMVI is a molecule and the convenience factors all come together. So I think it's a package of competitive products and ours is going to be, I think, highly competitive in this marketplace. And like I said, we think we're going to do really, really well in this space.

Next question, Emily Bodnar with H.C. Wainwright.

Maybe one on the updated guidance. Obviously, quite an uptick from the fourth quarter guidance. So maybe just talk a bit more on your confidence for why you think the growth you saw in Q1 might be sustained for the rest of the year? And also on operating expenses, it looks like that was up quite a bit in the first quarter. So maybe just touch on expectations for the rest of the year.

Sure. Adam, do you want to start on the updated guidance?

Yes, sure. Thanks for the question, Emily. Q1 performance, as I mentioned, was driven by strength across all key drivers, including record number of new patient starts and better-than-expected persistence. I think we're seeing that momentum continue into Q2. And as I outlined in my prepared remarks, the model really has two components to it. It's a growing recurring base with continued new patient demand. And so the strength of Q1 reflects both of these working together and gives us confidence in the updated full year guidance.

Sean, do you want to talk about the OpEx?

Sure. Thanks, Emily. Yes, on the OpEx front, as we said in our prepared remarks, we expect full year OpEx, again, which we define as R&D and SG&A, excluding stock-based comp, to be roughly $350 million, plus an additional $100 million for subcutaneous manufacturing work and secondary manufacturer preparation. So yes, Q1 was up a little bit higher than perhaps that range would guide, but we are still reiterating that guidance for the full year.

Next question, Prakhar Agrawal with Cantor Fitzgerald.

This is Jennifer on behalf of Cantor. Congrats on the quarter. I have two quick questions. One on the capital allocation and share buyback versus meaningful BD. Since you have quite a lot of cash. What's the plan on that? And then quickly on the gross to net discount for Q1, how do you expect that for the rest of the year?

Sure. Adam, why don't you or Sean handle the gross to net, and I'll talk about the use of cash.

Sure. Yes. As I mentioned in the Q4 call, we did have gross to net dynamics in Q1, but these were largely in line with our expectations. As I've mentioned before, gross to net can vary from quarter-to-quarter. But for the year, we expect it to average out around 65%.

And then in terms of use of cash and capital allocation and share buybacks versus BD. Look, we continue to be highly selective in our BD efforts. We've seen some interesting things. We like some stuff. We're disciplined about what we're willing to pay for programs and assets. And of course, we're always happy to buy our shares if others are not willing to value them at fair value. So we'll continue to buy back shares. I think that's -- until we see some significant price reassessment, we'll continue to be buying shares back with our cash. And like I said, yes, we're out there looking at new opportunities quite aggressively. And like I said, we've been disciplined about executing and certainly disciplined about price.

Next question, William Wood with B. Riley Securities.

Just thinking about in terms of sort of apart from BRIUMVI, you've got the earlier stage Azer-cel running in your open-label in PPMS. I'm just curious with that trial readout coming up later this year, if there's anything that you could sort of provide at a top level on what you might be seeing, what gives you confidence with advancing that? And then any -- yes, I'll stop there.

Appreciate it. Yes, for Azer-cel, it's still early. We are excited to be moving up in the dose escalation, but it's a challenging study logistically to get to a point where we can open up enrollment. So we'll continue to push forward. I think we're just about on the pen ultimate dose. I think we'll be able to start that in the next 1 to 2 weeks. So we're getting close. We're getting warm, but there's a significant delay between each individual patient while we strive to get to the dose that we're targeting. Safety, of course, is going to be the most important piece. Secondarily, of course, there's going to be some biomarkers of activity, whether we're deleting B cells, oligoclonal bands in the CNS. So we are hopeful to be able to present some of that data. But again, it's still early, but we're enthusiastic about it. We think the -- again, the rationale for these drugs has not subsided, and we do think that there's a real opportunity, but it's still early.

I would like to turn the floor over to Michael Weiss for closing remarks.

Great. Thank you, operator, and thanks again, everyone, for joining us this morning. Let me just briefly recap. We outperformed expectations commercially with strong revenue and record patient starts. We advanced two key life cycle programs, both with the near-term catalysts. We're expanding development efforts beyond MS into new indications, and we are allocating capital with discipline and intent. We've said this before, and it's worth repeating, we do not see BRIUMVI simply as a successful product. We see it as a multibillion-dollar franchise with a long runway, supported by patent protection into the 2040s. And importantly, even as we approach $1 billion run rate, we believe we're still early in realizing that full potential. We remain focused on executing the business and maximizing long-term value. I want to thank our shareholders for their continued support, our TG team for their commitment to our mission and the patients we serve and of course, to the patients and health care providers for their trust in us. We take that responsibility very seriously. Thank you all again for joining us, and have a great day.

This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.