TG Therapeutics Q1 2026 Earnings Report

TG Therapeutics EPS Results

• Actual EPS: $0.12
• Consensus EPS: $0.23
• Beat/Miss: Missed by -$0.11
• One Year Ago EPS: $0.03

TG Therapeutics Revenue Results

• Actual Revenue: $204.92 million
• Expected Revenue: $200.33 million
• Beat/Miss: Beat by +$4.59 million
• YoY Revenue Growth: +69.50%

TG Therapeutics Announcement Details

• Quarter: Q1 2026
• Date: 5/6/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, May 6, 2026
• Conference Call Time: 8:30AM ET

TG Therapeutics (NASDAQ:TGTX) is a clinical‐stage biopharmaceutical company headquartered in New York City that specializes in developing targeted therapies for hematological malignancies and autoimmune diseases. The company’s research strategy focuses on the modulation of B-cell biology through novel antibody and small‐molecule agents. Since its founding in 2003, TG Therapeutics has built a diversified portfolio aimed at addressing unmet medical needs in oncology and immunology.

In December 2022, TG Therapeutics achieved its first commercial milestone when ublituximab-xiiy (marketed as Briumvi® in collaboration with Biogen) received U.S. Food and Drug Administration approval for the treatment of relapsing forms of multiple sclerosis. Earlier, in February 2021, the company’s selective PI3Kδ inhibitor umbralisib (UKONIQ®) was granted accelerated approval by the FDA for relapsed marginal zone lymphoma and follicular lymphoma. These regulatory achievements underscore TG’s ability to advance candidates from discovery through critical review.

The company’s pipeline extends beyond its approved therapies to include next‐generation anti-CD20 antibodies, such as TG-1701, and novel PI3K inhibitors designed to improve safety and efficacy profiles. Additional programs in clinical development target complementary pathways in B-cell malignancies and autoimmune disorders. TG Therapeutics conducts multi‐center trials across North America and Europe to evaluate these assets in a range of disease settings, with an emphasis on optimizing combination regimens and identifying patient subgroups most likely to benefit.

Guided by a management team with deep experience in oncology drug development and regulatory affairs, TG Therapeutics leverages strategic partnerships, in‐house research capabilities and contract research organizations to accelerate its clinical programs. The company’s operations span discovery, translational research and late‐stage development, positioning it to address both rare and prevalent immune‐mediated diseases on a global scale.

TG Therapeutics Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: TG Therapeutics reported approximately $195 million in U.S. BRIUMVI net revenue in Q1 (>$200M globally), beat guidance and raised full‑year U.S. guidance to $885M–$900M (global ~$925M) with Q2 targeting ~$220M.
• Positive Sentiment: Commercial momentum shows durable adoption: >25,000 patients prescribed globally, 12 consecutive quarters of sequential growth, record new patient starts, improving persistence versus prior expectations, and leading dynamic CD20 share in private infusion practices.
• Positive Sentiment: Near‑term pipeline catalyst — top‑line data from the Phase III ENHANCE trial (single 600 mg initiation infusion vs. two‑infusion regimen) is expected in the coming weeks, and a positive result could enable a consolidated one‑infusion start and potential launch next year.
• Positive Sentiment: Subcutaneous BRIUMVI program is fully enrolled in Phase III with topline expected year‑end/early next year (Phase I bioavailability data also due soon); management targets a potential 2028 launch and says sub‑Q could materially expand the addressable anti‑CD20 market.
• Neutral Sentiment: Capital allocation and balance sheet: the company repurchased ~$100M of stock this quarter (≈6.8M shares total, ~5% of shares outstanding) and has ~$573M in cash/equivalents after extending the Blue Owl facility, while guiding for ~$100M of subcutaneous manufacturing/secondary manufacturer startup costs to be expensed this year.

Presentation

[Operator]

Greetings, and welcome to the TG Therapeutics first quarter conference call and webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. 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.

[Jenna Bosco, Chief Communications Officer at TG Therapeutics]

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.

[Jenna Bosco, Chief Communications Officer at TG Therapeutics]

Please note that these statements are subject to risks and uncertainties that can cause our actual results to differ materially from those indicated. These risks are detailed in our SEC filings. Additionally, any forward-looking statements made today reflect our views only as of this date, 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 Michael Weiss, our CEO.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

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 Q1, ahead of our guidance of $185 million-$190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

As we move toward a $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. That's translating into durable, repeatable growth. Importantly, the data continues to support that differentiation. Earlier this year, we were pleased to see our five-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.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

At AAN earlier this month, we continued 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. 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 the crap 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 and both strengthen and extend the franchise.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

First, our phase III ENHANCE study evaluating initiation of BRIUMVI therapy with a single 600 mg IV infusion as compared to the currently approved schedule of 600 mg divided into two infusions, one on day one-and-one on day 15. I'm pleased to report that based on current timelines, 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 for both patients and providers. Now turning to our subcutaneous program. We're developing a self-administered at home version of BRIUMVI expected to be delivered via an auto-injector and a pen-like device.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

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 sub-Q 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 two sub-Q dosing schedules every two months and quarterly dosing, with the primary endpoint being non-inferiority to IV based on drug exposure over 24 weeks. We were 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 sub-Q BRIUMVI, assuming a positive outcome and regulatory approval. I know many of you have been waiting for the phase I bioavailability data.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

We now expect to share those results in the coming weeks. Strategically, it is important to understand what sub-Q represents. This is not about incremental growth, and it is 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. 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.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

In 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, if validated, the implications could be significant. 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 extended our relationship with Blue Owl, enhancing our financial flexibility.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

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 business, repurchasing shares, or pursuing external opportunities or investments. With that, let me turn the call over to Adam Waldman, our Chief Commercial Officer, for a more detailed commercial update. Adam, please go ahead.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Thanks, Mike. Good morning, everyone. I'll pick up on a few themes 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-$900 million. We're providing Q2 guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. Importantly, we've now reached a meaningful milestone. More than 25,000 patients have been prescribed BRIUMVI globally.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

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 six 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.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

That combination is what's driving the business today. As we said before, the more patients that go on BRIUMVI, the more patients will go on BRIUMVI. We're seeing that dynamic take hold. Let me be direct about the competitive environment. We compete against established products with 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 number one 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 one-hour infusion, twice-yearly dosing, and long-term data all contribute to that.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

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. Most importantly, we're increasing uptake with treatment-naive 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. Our DTC efforts are helping to increase patient awareness, with more patients entering the office already informed about BRIUMVI.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

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. 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.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Today, the subcutaneous patient-administered segment represents roughly 35% of the anti-CD20 market, a segment we are not participating in today. 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. When you look at this holistically, IV plus sub-Q 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. Over time, they have the potential to meaningfully expand both the reach and long-term value of BRIUMVI.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

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. With IV and sub-Q, 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.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Let me now turn the call over to Sean Power, our CFO, for a detailed financial update.

[Sean Power, CFO at TG Therapeutics]

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 Neuraxpharm, 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.

[Sean Power, CFO at TG Therapeutics]

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-$8.6 million in Q1 of last year. One item worth flagging below the operating line was a one-time $9.2 million charge related to the refinancing of our Blue Owl facility, of which approximately 50% was non-cash. 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.

[Sean Power, CFO at TG Therapeutics]

On the balance sheet, we ended the quarter with approximately $573 million in cash equivalents, and investment securities, up from roughly $200 million at year-end, reflecting primarily the proceeds from the expanded Blue Owl Capital 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've 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.

[Sean Power, CFO at TG Therapeutics]

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 startup activities. As we've noted previously, those manufacturing costs are expensed through R&D as incurred. 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]

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. First question comes from Corinne Johnson with Goldman Sachs. Please go ahead.

[Corinne Johnson, Managing Director at Goldman Sachs]

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

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Sure. Adam, you wanna tackle that one?

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Sure. Yeah. Thanks for the question, Corinne. You know, as we mentioned, that segment represents about 35% of the CD20 market today. One we do not compete in, and you know, our perspective is this is expanding into a new patient population rather than you know, shifting patients within our existing base. We think of these as largely distinct segments with different patients and physician preferences. It importantly, I think, as Mike mentioned, you know, puts us in position to compete across both the IV and sub-Q space, you know, 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 gonna be great.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

You know, but you know, I think we subscribe to less is more. I think both would be a very strong profile, and we feel good about the opportunity for both, whichever way it works out.

[Corinne Johnson, Managing Director at Goldman Sachs]

Thanks.

[Operator]

Next question, Brian Cheng with JPMorgan. Please go ahead.

[Brian Cheng, Analyst at JPMorgan]

Hey, guys. Thanks for taking our questions this morning. Just first, can you talk a little bit about the cadence of data from the ENHANCE trial and the phase I bioavailability data? You know, in your prepared remarks, you said both data will be in the coming weeks. You know, which one should we expect first? Are both data coming at the same time? I have a follow-up. Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

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

[Brian Cheng, Analyst at JPMorgan]

Okay. You know, 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 a physician practice and asking for BRIUMVI? Thanks. Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Thanks for the question, Brian. Adam, you wanna tackle this one?

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Sure. I mean, on the persistence 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. We think these patterns that we're seeing, you know, are supportive of the durability of the patient experience, which obviously reflects the tolerability and efficacy of BRIUMVI. You know, that said, it's still early, and we will continue to monitor it. But, you know, we're growing in confidence as we continue to build as the data matures. You know, it comes down to, you know, sustainability of efficacy and tolerability.

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Generally, when patients do well, they stay on therapy, and that drives persistence. As far as DTC, we're encouraged. You know, 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. We're gonna continue to focus on it, and we're encouraged by what we're seeing so far.

[Brian Cheng, Analyst at JPMorgan]

Great. Thank you.

[Operator]

Next question, Tara Bancroft with TD Cowen. Please proceed.

[Analyst at TD Cowen]

Hi. Congrats on the quarter, and thanks for taking my question. This is Greg on for Tara. You've reiterated top-line phase III data for the sub-Q 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 sub-Q formulation become commercially available, assuming a favorable outcome? Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Sure. Our target is to have the sub-Q available sometime in 2028. In terms of the cadence of filing after the completion of that study, you know, 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 yeah, I mean, for 2028, as early as possible, 2027, we're gonna get that filing done. That's the goal. For 2028 approval, again, it's 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.

[Analyst at TD Cowen]

No. That covers my question. Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Okay. Thank you.

[Operator]

Next question. Next question, Roger Song with Jefferies. Please go ahead.

[Cha Cha Yang, Analyst at Jefferies]

Hi, this is Cha Cha Yang on for Roger. Thanks for taking my question. 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.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Yeah. Thanks for the question. You know, we continue to await product profiles for all the BTKs as it comes 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. I think we just have to wait. I mean, overall, we've maintained our position that there's, you know, certainly a home for these drugs in certain patient populations, particularly patients who are potentially secondary non-active secondary progressive, where we're not labeled. I think there's room for you know, remember, there's still a big oral market.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

I think there's room for a BTK with the right profile to participate in that oral marketplace. We don't think it's a drug class that will have a material impact on the CD20 class.

[Cha Cha Yang, Analyst at Jefferies]

Great. Thank you.

[Operator]

Next question, Michael DiFiore with Evercore ISI. Please go ahead.

[Michael DiFiore, Managing Director at Evercore ISI]

Hi, guys. Thanks so much for taking my questions. Just one from me. Given Roche's potential twice yearly home Ocrevus device and Kesimpta's longer interval work, what dosing profile does sub-Q BRIUMVI need to have in order to be meaningfully differentiated? Is every two-month dosing enough, or is quarterly dosing really the commercial bar, given where we're headed? Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Sure. Thanks for the question, Michael. 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, you know, the market is large. It can probably get larger on the sub-Q side. We'll continue to obviously have a very big presence in the IV sector. Whereas I don't think Ocrevus's long-term plan is to participate much longer in the IV marketplace. As you mentioned, they're working on their own at-home on-body device.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Like I said, from the standpoint of the patient, this is all great. As Adam Waldman 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 sub-Q side. Convenience is one thing. You know, obviously, as Adam Waldman said, quarterly is gonna 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 slowly comes out. Yeah, I think we're gonna do great.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

I mean, we've done quite well in the IV space. Again, BRIUMVI as a molecule and the convenience factors all come together. I think it's a package of competitive products, and ours is gonna be, I think, highly competitive in this marketplace. Like I said, we think we're gonna do really well in this space.

[Michael DiFiore, Managing Director at Evercore ISI]

Thank you.

[Operator]

Next question, Emily Bodnar with H.C. Wainwright. Please go ahead.

[Emily Bodnar, VP of Equity Research at H.C. Wainwright]

Hi. Thanks for taking the questions. 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. Also on operating expenses, looks like that was up quite a bit in the first quarter, so maybe just touch on expectations for the rest of the year.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Sure. Adam, you wanna start on the updated guidance?

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Yeah, sure. Thanks for the question, Emily. You know, 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. You know, I think we're seeing that momentum continue into Q2. You know, 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. The strength of Q1 reflects both of these working together and gives us confidence in the updated full-year guidance. Sean, you wanna talk about the OpEx?

[Sean Power, CFO at TG Therapeutics]

Sure. Thanks, Emily. Yeah, on the OpEx front, as we said in our prepared remarks, we expect full-year OpEx, you know, 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 our subcutaneous manufacturing work and secondary manufacturer preparation. Yeah, Q1 was up a little bit higher than perhaps that range would guide, but we are still reiterating that guidance for the full-year.

[Operator]

Thank you. Next question, Prakhar Agrawal with Cantor Fitzgerald, please go ahead.

[Jennifer Kim, Equity Research Director at Cantor Fitzgerald]

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

[Michael Weiss, Chairman and CEO at TG Therapeutics]

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

[Adam Waldman, Chief Commercial Officer at TG Therapeutics]

Sure. Yeah. You know, 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. For the year, we expect it to, you know, average out around 65%.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Thanks, Adam. In terms of use of cash and capital allocation and, you know, 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. Of course, we're always happy to buy our shares if others are not willing to value them at fair value. We'll continue to buy back shares. Until we see, you know, some significant price reassessment, we'll continue to be buying shares back with our cash. Like I said, yeah, we're out there looking at new opportunities quite aggressively.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Like I said, we've been disciplined about executing and certainly disciplined about price.

[Jennifer Kim, Equity Research Director at Cantor Fitzgerald]

Great. Thank you.

[Operator]

Next question, William Wood with B. Riley Securities. Please go ahead.

[William Wood, Analyst at B. Riley Securities]

Hi. Yes, thanks for taking our question. Just thinking about in terms of sort of apart from BRIUMVI, you know, 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, at a top level on what you might be seeing, what gives you confidence, with advancing that, and then any, Yeah, I'll stop there.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Thanks. Appreciate it. Yeah, for azer-cel, it's still early. We are you know 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 penultimate dose. I think we'll be able to start that in the next one to two 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. You know, safety, of course, is gonna be the most important piece. Secondarily, of course, is gonna be some biomarkers of activity. You know whether we're deleting B cells, oligoclonal bands in the CNS.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

We are hopeful to be able to present some of that data, but again, it's still early. You know, we're enthusiastic about it. We think again, the rationale for these drugs has not subsided. We do think that there's a real opportunity, but it's still early.

[William Wood, Analyst at B. Riley Securities]

Got it. Thank you.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Thank you.

[Operator]

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

[Michael Weiss, Chairman and CEO at TG Therapeutics]

Great. Thank you, operator. 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 multi-billion dollar franchise with a long runway, supported by patent protection into the 2040s. Importantly, even as we approach a billion-dollar 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.

[Michael Weiss, Chairman and CEO at TG Therapeutics]

I wanna 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 healthcare providers who put their trust in us. We take that responsibility very seriously. Thank you all again for joining us, and have a great day.

[Operator]

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

Participants

Executives

• Adam Waldman, Chief Commercial Officer
• Jenna Bosco, Chief Communications Officer
• Michael Weiss, Chairman and CEO
• Sean Power, CFO

Analysts

• Brian Cheng, Analyst at JPMorgan
• Cha Cha Yang, Analyst at Jefferies
• Corinne Johnson, Managing Director at Goldman Sachs
• Emily Bodnar, VP of Equity Research at H.C. Wainwright
• Jennifer Kim, Equity Research Director at Cantor Fitzgerald
• Michael DiFiore, Managing Director at Evercore ISI
• William Wood, Analyst at B. Riley Securities
• Analyst at TD Cowen