NASDAQ:TGTX TG Therapeutics Q4 2025 Earnings Report $38.57 +2.47 (+6.83%) As of 10:53 AM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast TG Therapeutics EPS ResultsActual EPS$0.14Consensus EPS $0.35Beat/MissMissed by -$0.21One Year Ago EPS$0.15TG Therapeutics Revenue ResultsActual Revenue$192.57 millionExpected Revenue$192.15 millionBeat/MissBeat by +$424.00 thousandYoY Revenue Growth+78.00%TG Therapeutics Announcement DetailsQuarterQ4 2025Date2/26/2026TimeBefore Market OpensConference Call DateThursday, February 26, 2026Conference Call Time8:30AM ETUpcoming EarningsTG Therapeutics' Q2 2026 earnings is estimated for Wednesday, May 6, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by TG Therapeutics Q4 2025 Earnings Call TranscriptProvided by QuartrFebruary 26, 2026 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: TG reported strong commercial momentum with approximately $616 million in 2025 global revenue (≈$594M U.S. BRIUMVI net sales), Q4 U.S. sales of $183M (+92% YoY, +20% sequential), and reaffirmed 2026 guidance of $825M–$850M U.S. (total global $875M–$900M). Positive Sentiment: Long‑term clinical data bolster confidence — six‑year open‑label ULTIMATE I/II results showed ~90% of patients free from 24‑week confirmed disability progression and no new safety signals — and the ENHANCE Phase 3 consolidation trial (one 600 mg dose) is fully enrolled with top‑line data expected mid‑year and potential 2027 launch. Positive Sentiment: The subcutaneous BRIUMVI program is ~75% enrolled in Phase 3, with pivotal readouts late this year/early next and a potential 2028 launch; management believes a sub‑Q, at‑home option could meaningfully expand the anti‑CD20 market and nearly double their TAM. Neutral Sentiment: Financially TG is generating operating income, expects positive cash flow in 2026+, and completed a $100M buyback with another $100M authorized, but 2025 net income was boosted by a ~$340M one‑time tax benefit and Q4 gross margin was affected by a one‑time inventory reserve. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallTG Therapeutics Q4 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Greetings, welcome to the TG Therapeutics Fourth Quarter and Year-End 2025 Earnings Call. 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 during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Chief Communication Officer. Please proceed. Jenna BoscoCCO at TG Therapeutics00:00:30Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' Fourth Quarter and Year-End 2025 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. Jenna BoscoCCO at TG Therapeutics00:01:24Please note that these statements are subject to risks and uncertainties that could 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 corporate website at www.tgtherapeutics.com. With that, I'll turn the call over to Mike Weiss, our CEO. Michael WeissChairman and CEO at TG Therapeutics00:02:00Thank you, Jenna, and good morning, everyone, and thank you for joining us today. 2025 was a defining year for TG Therapeutics. We didn't just grow, we scaled, we strengthened, and we demonstrated that BRIUMVI is becoming a foundational therapy in relapsing multiple sclerosis. Let's start with what matters most, performance. We delivered approximately $616 million in total global revenue, the vast majority of which came from $594 million of BRIUMVI U.S. net sales, and we capped the year with a strong fourth quarter of $183 million. That represents approximately 92% year-over-year growth and 20% sequential growth from Q4 over Q3. Those numbers reflect something simple. Physicians are choosing BRIUMVI, patients are staying on BRIUMVI, and confidence in the product continues to build. Michael WeissChairman and CEO at TG Therapeutics00:02:52That confidence is reinforced by our six-year open-label extension data from ULTIMATE I and II, presented in ECTRIMS this past September. Nearly 90% of the patients were free from 24-week confirmed disability progression after six years of continuous treatment. Six years! The relapse rate seen in the six-year BRIUMVI treatment translates into one relapse occurring in every 83 years of treatment. Importantly, no new safety signals emerged. On the R&D front, we advanced our phase III ENHANCE study evaluating consolidation of the day one and day 15 BRIUMVI infusions into a single 600 milligram dose. Enrollment is complete. We expect top-line data mid-year with a potential 2027 launch of this consolidated treatment schedule. If successful, this could meaningfully simplify the treatment experience. We believe effective therapies should not only work well, but be as convenient as possible for patients. Michael WeissChairman and CEO at TG Therapeutics00:03:54Which brings me to our subcutaneous program. We're developing a self-administered, at-home sub-Q BRIUMVI to be delivered via an auto-injector. Our phase III study is evaluating two dosing schedules; every two months and quarterly administration. The trial is now approximately 75% enrolled, and we're targeting pivotal top-line data later this year or early next year, with a potential 2028 launch. We see this program as having significant commercial potential. The sub-Q portion of the anti-CD20 market is substantial, and being able to compete in this space, we believe, could nearly double our total addressable market opportunity. Beyond MS, we are actively advancing plans to explore BRIUMVI in additional autoimmune indications, including having treated a series of myasthenia gravis patients in a phase I study. Finally, azer-cel, our allogeneic anti-CD19 CAR T, is being studied in patients with progressive MS. It's still early, but momentum is building. Michael WeissChairman and CEO at TG Therapeutics00:04:59Our clinical trial sites are identifying patients quickly. In fact, demand is exceeding available trial slots. That tells us something important. There's a real unmet medical need. We look forward to sharing updates from this program later this year. Turning to some financials. I'll leave the details to Adam and Sean, but suffice to say, we expect to continue generating positive cash flow in 2026 and beyond, which gives us a rare financial flexibility within the biotech universe. We've been clear about our capital priorities: invest to maximize the multi-billion dollar BRIUMVI opportunity, expand the pipeline judiciously for sustained future growth, repurchase shares when we believe TG is materially undervalued, and otherwise allocate capital in ways that generate long-term returns. Michael WeissChairman and CEO at TG Therapeutics00:05:51With respect to share buybacks, we completed our first $100 million share repurchase program, and the board authorized an additional $100 million last year. At current levels, we view our shares as significantly undervalued relative to the cash flow profile we expect over the coming years, and we will not hesitate to act accordingly, including adding leverage to reduce our share count. To be clear, we purchase shares to create long-term value, not for the optics. Before closing, I want to touch on something I'm personally very proud of. Many of you saw Christina Applegate launch Next in MS during Super Bowl LX. We are honored to partner with her on this platform. Next in MS is about honest, unfiltered conversations, about life with MS, about difficult realities, about resilience beyond treatment decisions. Michael WeissChairman and CEO at TG Therapeutics00:06:42We're not just commercializing BRIUMVI, we're building the MS company that shows up for patients beyond the prescription. To close, at TG, our mission remains simple: deliver meaningful therapies, simplify treatment, create lasting value for patients and shareholders. I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, for a detailed commercial update. Adam, go ahead. Adam WaldmanCCO at TG Therapeutics00:07:09Thanks, Mike, good morning, everyone. 2025 was a year of continued acceleration for BRIUMVI, and we closed the year with another strong quarter of execution and growth, further expanding our position in the RMS market. For the fourth quarter of 2025, we delivered U.S. net sales of $183 million and continued sequential expansion versus Q3. For the full year, BRIUMVI U.S. net revenue reached $594 million, reflecting sustained momentum built on the strong commercial foundation established in the first three years of launch. Growth throughout the year was driven by consistent and increasing year-over-year new patient starts, continued expansion of our prescriber base, better than expected persistence, greater depth within high-volume infusion accounts. Importantly, growth was broad-based across both academic and community settings, reflecting rising physician confidence and expanding utilization. Adam WaldmanCCO at TG Therapeutics00:08:00BRIUMVI continues to strengthen its competitive position within a large and growing anti-CD20 market. Within the IV anti-CD20 segment, we continue to gain dynamic share. Physicians remain focused on proven efficacy, long-term safety experience, and operational efficiency. BRIUMVI's one-hour, twice-yearly maintenance infusion profile, supported by multiyear data, continues to resonate in a competitive environment. We're seeing a balanced mix of treatment-naive and switch patients, reinforcing both the breadth of the opportunity and the continued expansion of our footprint within the class. Our execution remains strong across all commercial functions. TG is emerging as a leader in the therapeutic category. As the franchise continues to scale, we have continued to invest behind the business. During 2025, we expanded our field organization to deepen coverage in high-opportunity geographies and broaden our reach among community neurologists and independent infusion centers. Adam WaldmanCCO at TG Therapeutics00:09:00That expanded footprint is driving increased prescriber engagement and positions us to accelerate further penetration in 2026. We also expanded our direct-to-patient engagement efforts during the year. In addition to our national BRIUMVI campaign, as Mike mentioned, we recently announced our partnership with Christina Applegate to launch NextInMS.com, a new educational platform designed to provide resources and information to individuals living with RMS and their caregivers. Christina's long-standing advocacy within the MS community brings credibility and visibility to broader conversations around navigating life with MS. Through Next in MS, our focus is on education, empowerment, and encouraging informed dialogue between patients and their healthcare providers. Adam WaldmanCCO at TG Therapeutics00:09:51As BRIUMVI continues to scale, we believe it's important to engage thoughtfully and meaningfully in, within the MS community, and this partnership reflects our growing leadership, position in the space and our long-term commitment to supporting the MS community. As we look to 2026, we are reaffirming our previously issued full-year U.S. BRIUMVI net revenue guidance of $825 million-$850 million, with total global revenue, at $875 million-$900 million. Our outlook reflects continued growth, driven by expanding prescriber adoption, increasing depth within existing accounts and ongoing share gains, and a growing installed base of patients with strong persistence on therapy. We've entered 2026 with real momentum. New patient starts are tracking to our strongest levels since launch. Adam WaldmanCCO at TG Therapeutics00:10:40Physician confidence continues to build, and our share trajectory within the IV anti-CD20 segment remains favorable. Importantly, after operating alongside competitive entrants for several quarters, BRIUMVI has demonstrated that it can compete effectively and continue to expand its position within the class. Turning to the first quarter, and based on the strong demand trends we're seeing early in the year, we expect U.S. revenue to grow sequentially over Q4 levels to approximately $185 million-$190 million, even after accounting for typical seasonal headwinds. As we have mentioned previously, the first quarter generally reflects routine factors such as benefit reverifications and gross and net variability driven by deductible resets, which can influence the timing of net revenue early in the year. Adam WaldmanCCO at TG Therapeutics00:11:31These dynamics are consistent with what we've seen historically in the category and are fully incorporated into our full year guidance. We also expect ex-U.S. revenue to be in the range of $5 million-$10 million for the first quarter. Taken together, the strength of demand and continued share expansion gives us confidence in our reaffirmed guidance and our ability to drive meaningful growth in 2026. To summarize, we have delivered another year of strong growth in 2025. We continue to gain share in a competitive IV anti-CD20 market. We have invested meaningfully in field expansion and direct-to-consumer initiatives to support the next phase of growth. We are off to a very strong start in 2026, tracking to record new patient enrollments entering the year. Adam WaldmanCCO at TG Therapeutics00:12:19BRIUMVI is now a scaled and expanding franchise. We believe the commercial platform we've built positions us well to continue driving meaningful growth in the year ahead. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:12:34Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we released our fourth quarter and full year 2025 financial results, which are available in the Investors and Media section of our website. I'll begin with a discussion of our revenue for the fourth quarter and full year, which Adam briefly touched on. We are pleased to report U.S. BRIUMVI net product revenue of $182.7 million during the fourth quarter. Total net product revenue for the quarter was $189.1 million, which includes $6.4 million of product revenue related to sales to our partner, Neuraxpharm, in support of ex-U.S. commercialization. Sean PowerCFO at TG Therapeutics00:13:19For the full year 2025, global revenue was approximately $616 million, predominantly comprised of $594 million in U.S. BRIUMVI net products revenue, $12.8 million in revenue from products supplied to Neuraxpharm, and $9.4 million in royalty and other revenue. Our gross margin for the quarter was slightly below typical as a result of timing of sales to our ex-U.S. partner and a one-time inventory reserve. Shifting to operating expenses, which we define as R&D and SG&A, excluding non-cash comp. Full year 2025 expenses totaled approximately $328 million, in line with our prior guidance of $300 million-$320 million. The modest variance was driven primarily by incremental manufacturing and development costs related to subcutaneous BRIUMVI and continued commercial investment. Sean PowerCFO at TG Therapeutics00:14:21Revenue growth significantly exceeded the increase in operating expenses, resulting in operating income of $123 million for the year. For the fourth quarter, net income was $23 million, or $0.14 per diluted share. For the full year 2025, net income totaled $447.2 million, or $2.77 per diluted share, compared to $23.4 million, or $0.15 per diluted share in 2024. As a reminder, 2025 results, including non-recurring income tax benefit of approximately $340 million, which relates primarily to the release of our deferred tax asset valuation allowance in the third quarter. Sean PowerCFO at TG Therapeutics00:15:12Turning to our balance sheet and capital position, we ended the year with more than $600 million in current assets, approximately $200 million in cash equivalents and investment securities, $300 million in accounts receivable and $140 million in inventory. During the year, we completed our previously authorized $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share. The board has since authorized an additional $100 million share repurchase program, reflecting continued confidence in our long-term outlook. Looking ahead to 2026, we expect full-year operating expenses of approximately $350 million, excluding non-cash comp, plus approximately $100 million in expenses associated with subcutaneous BRIUMVI manufacturing and secondary manufacturer startup activities. Sean PowerCFO at TG Therapeutics00:16:15These costs run through R&D today, but if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods, as the manufacturing expense has already been recognized, positively impacting gross margin in future periods. In summary, 2025 represented a year of strong execution for TG. We delivered substantial revenue growth, generated meaningful operating income, and positioned the company for continued expansion in 2026. With that, I will now turn the call back over to the conference operator to begin the Q&A. Operator00:16:58Thank you. We will now conduct 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 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one at this time. One moment while we pull for our first question. The first question comes from Michael Schmidt with Evercore ISI. Please proceed. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:17:33Hi, guys. Thanks so much for taking my questions. Two for me. Roche has recently highlighted accelerating sub-Q uptake in community practices, and Novartis continues to emphasize strong growth in the self-administered first-line use. You've described broad momentum across academic and community settings in the HCP administered segment. My question is, can you help us think about how those dynamics fit together and where you're currently seeing the strongest incremental momentum by site of care? I have a follow-up. Michael WeissChairman and CEO at TG Therapeutics00:18:10Sure. Thanks for the question. Adam, you want to go ahead? Adam WaldmanCCO at TG Therapeutics00:18:15Yeah, sure. Thanks for the question, Mike. You know, listen, we've now operated alongside the new entry from Roche for several quarters now. We continue to seek, you know, shares gains in the IV segment. Physicians seem to be continue to be driven by clinical data, long-term data, operational considerations. It seems like the majority of the Zeposia business seems to be coming from Ocrevus IV. Importantly, we're not seeing any decreases in the switches from Ocrevus to BRIUMVI, so that's an important factor, too. In terms of, you know, what's driving our share, we're seeing growth across both private practice and academic centers. Adam WaldmanCCO at TG Therapeutics00:19:03We think it's the durability of the clinical profiles, as Mike mentioned, the six-year data, especially the, you know, the safety data within there and the efficacy data. We continue to believe the operational advantages of BRIUMVI, the one-hour infusion, twice a year, are relevant for patients in infusion centers. We continue to expand prescriber breadth and depth with our expansion of our, you know, our field force. I think, you know, we're seeing great momentum, and as I mentioned, the underlying demand is very strong. Enrollments are tracking to the highest since launch. You know, we continue to see share gains across the board, across patient types, across sites of care. Importantly, also, we see very strong persistence. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:19:51Overall, really strong, and, you know, the fundamentals are great. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:19:57Very helpful. My follow-up question is on gross to net. You previously noticed that gross net can fluctuate with site of care mix, particularly in hospital exposure. As growth evolves across channels, are you seeing any meaningful change in gross to net assumptions, or does your prior framework still hold? Adam WaldmanCCO at TG Therapeutics00:20:19Yeah, you know, as I mentioned in the in the prepared remarks, gross to net can vary quarter to quarter. In Q1, gross to net is influenced by deductible resets and high utilization of co-pay programs. Consistent with what we've seen historically, does not represent a structural change in, you know, how we think about gross to net. It's a, you know, it's a, you know, a Q1 dynamic. Our full year guide reflects the net revenue profile for this year. It is a Q1 dynamic that seems to be consistent with what we see across the CD20 space, also other specialty products, and it's fully baked into our full year guidance. I hope that answers the question. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:21:03Thanks so much. Operator00:21:06The next question comes from Tara Bancroft with TD Cowen. Please proceed. Tara BancroftDirector and Biotech Senior Research Analyst at TD Cowen00:21:11Hi, good morning. I'm curious to hear your thoughts around positioning now that you know, you're several years into this launch, but, you know, guidance for Q1 and the year are pretty conservative. I was hoping you could give us some more detail on the proportion of new versus switch patients and how much revenue now is from patients that are remaining on treatment for these extended periods of time. Whether new patient starts are still growing or leveling off, and why? Thanks. Michael WeissChairman and CEO at TG Therapeutics00:21:44Thanks, Tara. Adam, it's all you still. Go ahead. Adam WaldmanCCO at TG Therapeutics00:21:49Yeah, thanks for the question, Tara Bancroft. You know, listen, I think I'll just reiterate what we're seeing. The majority, you know, we're seeing record new patient enrollments here. We're still seeing growth. We're seeing great share gains in the IV segment. I think that's being driven by the things that I mentioned, durability of the clinical profile, the six-year data, the operational advantages. Our investment in both the expansion of our field force, it could very well be our DTC efforts, although hard to, you know, single out a single factor here. All these things, I think, are leading to continued confidence in the product across the board, and that's why we're seeing such a great demand that we're seeing right now. Adam WaldmanCCO at TG Therapeutics00:22:33As far as new versus switch, you know, I mentioned a couple quarters ago, the business becomes more predictable as we've now walked into more repeat patients. We are seeing more and more repeat patients as a bigger part of our business, as that, you know, patients continue to pancake from quarter to quarter and stay on therapy for long periods of time. As I mentioned before, also, our persistence is quite strong. We're seeing patients staying on therapy for it looks like out to week 48, week 72, week 96 seems very good. All those things are leading to growth. Adam WaldmanCCO at TG Therapeutics00:23:17We do expect full, you know, we do expect growth in 2026 and meaningful growth in the in our guidance. Tara BancroftDirector and Biotech Senior Research Analyst at TD Cowen00:23:27Okay, great. Thank you. Operator00:23:32The next question comes from Prakhar Agrawal with Cantor Fitzgerald. Please proceed. Prakhar AgrawalSenior Biotech Analyst at Cantor Fitzgerald00:23:38Hi, congrats on the quarter, and thank you for taking my questions. Maybe just to follow up on the new patient start. Adam Waldman, you said you're seeing a good growth in new patient starts, but I'm trying to connect the dots between your commentary as well as what's implied in the guidance, because based on our math, the guidance would imply a more modest year-on-year growth on new patient start. How much conservatism is baked into the guidance, or should we expect about higher growth to net for full year 2026? Secondly, how much incremental investments would you need for the sub-Q launch? What would be the plans to commercialize sub-Q BRIUMVI ex-U.S.? Given that it seems to be a large market for drugs like MS drugs, there could be a lot of value there. Thank you. Adam WaldmanCCO at TG Therapeutics00:24:29Yeah. Mike, you want me to continue to go here? Michael WeissChairman and CEO at TG Therapeutics00:24:33Yeah, why don't you start off? Go ahead. Adam WaldmanCCO at TG Therapeutics00:24:36Yeah. Yeah. I mean, look, we're early in the year here. Like I said, we're seeing a strong start to the year. We're early here. We'll continue to update the guidance as we see fit, as we continue to get more time, see how we do throughout the year. It's, of course, you know, possible that we could see outperformance, that could come from, you know, continued new patient starts. We could see incremental share gains. We could see, you know, better than expected persistence. That's, you know. We're being somewhat conservative here, but, you know, so far the year's starting strong, but we're, you know, again, we're only in February. We'll see how that goes. Adam WaldmanCCO at TG Therapeutics00:25:19You know, in Q1, we're seeing, you know, just the disconnect in Q1, Prakhar, to your question, strong, new patient growth. However, you know, you do face the Q1 issues and headwinds that I described on gross to net and benefit reverification. Mike, I don't know if you want to take the sub-Q question. Michael WeissChairman and CEO at TG Therapeutics00:25:40Sure. Yeah. I mean, in terms of incremental investment, Prakhar, you can answer this as well as me, but, you know, over-overlap between our current field force for IV to subQ is I think about 80%. There's not a huge incremental cost, there'll obviously be some incremental marketing costs associated with it, but overall, it's not a huge incremental, investment to launch subQ in the U.S. As for ex-U.S., we expect, our partners at Neurax will opt into that program, when offered it, we'll work with them on the ex-U.S., strategy at that point. Prakhar AgrawalSenior Biotech Analyst at Cantor Fitzgerald00:26:25Thank you. Michael WeissChairman and CEO at TG Therapeutics00:26:27Thank you. Operator00:26:29The next question comes from Corinne Johnson, Goldman Sachs. Please proceed. Corinne JohnsonVice President of Equity Research at Goldman Sachs00:26:35Good morning. Maybe continue on the conversation on sub-Q. Some of the competitors in the space have started providing color on the role they think a sub-Q offering could play over time with respect to IV versus sub-Q share. I guess, what is your perspective there, particularly given the variety of dosing options within sub-Q that could be coming over the next couple of years, including obviously BRIUMVI? Thanks. Michael WeissChairman and CEO at TG Therapeutics00:26:58Sure. I'll give it a start, Adam, to supplement, if you like. You know, look, the sub-Q portion of the market has been relatively stable, for a while, I think 35% to maybe 40%. It fluctuates up and down quarter to quarter. You know, long term, you know, the more options that are available creates more, you know, energy in that space and more people marketing in that space. I do believe that over time, with new options available, that space can expand and probably will expand. To what extent is hard to predict at this moment, but I do think there's probably some, forces that will push people toward, towards sub-Q at home over time. Yeah, I do think that market will continue to, grow. Adam, any additional thoughts? Adam WaldmanCCO at TG Therapeutics00:27:52No, that's perfect, thanks. Corinne JohnsonVice President of Equity Research at Goldman Sachs00:27:55Thanks. Michael WeissChairman and CEO at TG Therapeutics00:27:57Thank you. Operator00:28:01The next question comes from Brian Cheng with JPMorgan. Please proceed. Brian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.00:28:08Hey, guys. Thanks for taking our question this morning. Just looking at the existing sales force, is there any potential need for a refocus of their goal this year? Are there pocket of opportunities that you think might be more important this year, just given more adoption on the sub-Q side? On a related note, how should we think about the expenses projection related to the DTC campaign that you have set up for this year? What might be two of the step up that we expect? Thank you. Michael WeissChairman and CEO at TG Therapeutics00:28:45Thanks, Brian. Adam, you want to lead us off here? Adam WaldmanCCO at TG Therapeutics00:28:50Sure. Yeah, thanks for the question, Brian. You know, we, as I've mentioned before, we continue to take a strategic expansion approach to our field force. We have continued to add people as we've seen opportunities to do so. We're looking at it strategically. We add people where we see opportunity, and continue to hire the best people that we can find in the area. As far as a new goal, you know, I don't, I don't know that it needs a new goal. I think we have a, you know, a pay-for-performance culture, and an accountable culture. We have, we've hired the best people in the industry. You know, this team is fantastic, and they continue to deliver on what we've asked them to do. Adam WaldmanCCO at TG Therapeutics00:29:42I don't think we need a new goal. I think we have a great team. I'm very confident in the, in the commercial, the commercial functions. As I mentioned, I think they're doing an excellent job. Brian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.00:29:53Great. Thank you. Operator00:29:57The next question comes from William Wood, with B. Riley. Please proceed. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:30:03Hi, thank you for taking our questions. Thinking about some of your sub-Q and phase III that's going on currently, I'm just curious when we might actually see, or if there's a chance that we might see any sub-Q bioequivalence data generated. How we can sort of think about that phase III readout later this year. Also in terms of some of the earlier stage programs, I know you've got phase I ongoing in myasthenia gravis. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:30:32Just curious if and when we might expect to see some of these earlier stage data from the earlier stage programs, any of that reading out later this year at conferences? Michael WeissChairman and CEO at TG Therapeutics00:30:44Sure. Thanks for the question, William. In terms of sub-Q, yes, as we discussed, phase III is approximately 75% enrolled. We continue to be excited about that program, and it's the opportunity for us there. Phase III data is expected later this year or early next year. In terms of the phase I bioequivalence data, you know, it's been coming in. The study is actually, I think, just about to close formally. There's overlap between the phase III and the phase I, just the follow-up, and all those kinds of things. The phase I is, I think, just about closing up or maybe it's not there yet, but getting close. Michael WeissChairman and CEO at TG Therapeutics00:31:25We'll take a look at the timing of conferences and the timing of phase III data and see if it makes sense to actually put the phase I data out or not, based on timing of where we are at the phase III and the conference schedule that's available once that data is fully evaluated in presentable format. The answer is, I don't know as of yet. Like I said, you know, based on the preliminary data, we're feeling very good about the program and very excited about the phase III outcome that will be later this year. In terms of phase I-MG, I have not talked to the team yet about what their plans are for presenting that information. Michael WeissChairman and CEO at TG Therapeutics00:32:06Anecdotally, I know the study, the patients who've been treated with MG look quite good in terms of their response to the drug, which I don't think is much of a surprise to anybody. I'll check back with the team and I'll be able to give some more guidance later on that once I find out what their plans are. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:32:27Got it. Thank you very much. Thanks for answering our questions. Michael WeissChairman and CEO at TG Therapeutics00:32:31Thank you. Operator00:32:33The next question comes from Emily Bodnar with H.C. Wainwright. Please proceed. Emily BodnarVice President of Equity Research at H.C. Wainwright00:32:38Hi, good morning. Thanks for taking the questions. In terms of the ENHANCE trial and launching that next year, can you just talk about how you think about that from a market perspective, and if you see any potential for kind of incremental revenue growth with implementing that launch? Then maybe if you could just talk a bit about some early metrics that you're tracking with the DTC launch and the Next in MS program. Thanks. Michael WeissChairman and CEO at TG Therapeutics00:33:08Sure. Thanks for the question, Emily. In terms of the ENHANCE trial and launch, and incremental potential from that, I'll take a crack at it, and then please jump in. You know, we've done some market research. Generally speaking, it's extremely positive feedback on eliminating that second dose. The convenience factor for both patient and for centers is viewed very high in the research we're doing. Anecdotally, I've personally been in advisory boards recently, where people are even more enthusiastic than they've previously been about reducing that first dose. In terms of incremental, you know, market share gains, I think from our research and from, you know, the anecdotal experience that we have, we do believe that it will help us continue to gain market share gains in this area. Michael WeissChairman and CEO at TG Therapeutics00:34:07You know, again, it's just, every time we make it easier, it's just, it's better. In terms of the other side of it, in terms of switches, people are excited about it to use this, you know, on label for switches, which we think will be helpful there. Generally speaking, if you're looking at, you know, going on IV Ocrevus or IV BRIUMVI, you now have another reason or another convenience reason to go on to BRIUMVI, eliminating that first dose, which they will still have two doses up front for their IV, plus the much longer infusion. Yeah, we do think that'll have a positive impact, and we're looking forward to that launch. Adam, anything more on that topic? Adam WaldmanCCO at TG Therapeutics00:34:54No, I think you covered it. That was great. Michael WeissChairman and CEO at TG Therapeutics00:34:57Okay. The second part of the question was early metrics on DTC. I know that's one of Adam's favorite topics, so I'll hand it off to him. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:35:08No, thanks for the question, Emily, and asking about our partnership with Christina on Next in MS. You know, as I mentioned, we view these efforts as building long-term category leadership. The feedback from customers and patients and advocacy groups has been incredibly positive. So far, obviously, we're looking at, you know, in terms of metrics that you asked about, you know, the engagement with the content has been has exceeded our expectations. We're looking at, you know, the number of people who sign up on our website, the number of website visits, number of sessions. We'll continue to track it, but so far, everything has exceeded our expectations, and the engagement with the materials has been fantastic. Emily BodnarVice President of Equity Research at H.C. Wainwright00:35:53Okay. Thank you. Michael WeissChairman and CEO at TG Therapeutics00:35:56Thanks, Emily. Appreciate it. Operator00:35:58Thank you. At this time, I would like to turn the call back to Mike Weiss for closing comments. Michael WeissChairman and CEO at TG Therapeutics00:36:03Great. Thank you, operator, and thanks again, everyone, for joining us. 2025 was a very strong year for us. 2026, we expect to be even stronger, including a number of very exciting catalysts, including the top-line data from our ENHANCE trial, some preliminary data from azer-cel, then perhaps the biggest one of all, at the end of the year or early next year, pivotal data from subcutaneous BRIUMVI program. To our TG employees, thank you always for your dedication to those living with MS. To the healthcare providers, individuals with MS, and their families, thank you for your trust. To our long-term shareholders, thank you for recognizing the potential of what we are building here at TG. We're just getting started. Have a great day. Operator00:36:51Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.Read moreParticipantsExecutivesAdam WaldmanCCOAdam WaldmanChief Commercialization OfficerJenna BoscoCCOMichael WeissChairman and CEOSean PowerCFOAnalystsBrian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.Corinne JohnsonVice President of Equity Research at Goldman SachsEmily BodnarVice President of Equity Research at H.C. WainwrightMichael SchmidtManaging Director and Equity Research Analyst at Evercore ISIPrakhar AgrawalSenior Biotech Analyst at Cantor FitzgeraldTara BancroftDirector and Biotech Senior Research Analyst at TD CowenWilliam WoodHealthcare Equity Research Analyst at B. Riley SecuritiesPowered by Earnings DocumentsPress Release(8-K)Annual report(10-K) TG Therapeutics Earnings HeadlinesTG Therapeutics Reports First Quarter 2026 Financial Results and Raises BRIUMVI Revenue Guidance3 hours ago | globenewswire.comTG Therapeutics to Host Conference Call on First Quarter 2026 Financial Results and Business UpdateApril 30, 2026 | globenewswire.comPH: Do THESE 4 things to your bank account now …In a few short months, the US government could gain unprecedented powers over personal bank accounts - including the ability to track every transaction or freeze funds. Martin D. Weiss, PhD, founder of Weiss Ratings, has identified 4 simple steps Americans can take today to help safeguard their savings before any changes take effect.May 6 at 1:00 AM | Weiss Ratings (Ad)TG Therapeutics Announces Data Presentations for BRIUMVI in Multiple Sclerosis at the American Academy of Neurology 2026 Annual MeetingApril 22, 2026 | finance.yahoo.comA Look At TG Therapeutics (TGTX) Valuation After Recent Share Price MomentumApril 19, 2026 | finance.yahoo.comTG Therapeutics: Flawless Execution And $500 Million Non-Dilutive Capital Bolster OutlookApril 18, 2026 | seekingalpha.comSee More TG Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like TG Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on TG Therapeutics and other key companies, straight to your email. Email Address About TG TherapeuticsTG 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.View TG Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Years in the Making, AMD’s Upside Movement Has Just BegunPinterest Pins a Profit Play To Its Mood BoardJust How Big a Problem Could Amazon’s Cash Burn Rate Be?BlackBerry Rewrites Its Own Operating SystemGrab Holdings Faces Hurdles, But Upside Potential Is Hard to IgnorePalantir Drops After a Blowout Q1—What Investors Should KnowShopify’s Valuation Crisis Creates Opportunity in 2026 Upcoming Earnings Coinbase Global (5/7/2026)Airbnb (5/7/2026)Datadog (5/7/2026)Ferrovial (5/7/2026)Gilead Sciences (5/7/2026)Microchip Technology (5/7/2026)MercadoLibre (5/7/2026)Monster Beverage (5/7/2026)Canadian Natural Resources (5/7/2026)W.W. 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PresentationSkip to Participants Operator00:00:00Greetings, welcome to the TG Therapeutics Fourth Quarter and Year-End 2025 Earnings Call. 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 during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Chief Communication Officer. Please proceed. Jenna BoscoCCO at TG Therapeutics00:00:30Thank you. Welcome, everyone, and thank you for joining us this morning. I'm Jenna Bosco, and with me to discuss TG Therapeutics' Fourth Quarter and Year-End 2025 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. Jenna BoscoCCO at TG Therapeutics00:01:24Please note that these statements are subject to risks and uncertainties that could 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 corporate website at www.tgtherapeutics.com. With that, I'll turn the call over to Mike Weiss, our CEO. Michael WeissChairman and CEO at TG Therapeutics00:02:00Thank you, Jenna, and good morning, everyone, and thank you for joining us today. 2025 was a defining year for TG Therapeutics. We didn't just grow, we scaled, we strengthened, and we demonstrated that BRIUMVI is becoming a foundational therapy in relapsing multiple sclerosis. Let's start with what matters most, performance. We delivered approximately $616 million in total global revenue, the vast majority of which came from $594 million of BRIUMVI U.S. net sales, and we capped the year with a strong fourth quarter of $183 million. That represents approximately 92% year-over-year growth and 20% sequential growth from Q4 over Q3. Those numbers reflect something simple. Physicians are choosing BRIUMVI, patients are staying on BRIUMVI, and confidence in the product continues to build. Michael WeissChairman and CEO at TG Therapeutics00:02:52That confidence is reinforced by our six-year open-label extension data from ULTIMATE I and II, presented in ECTRIMS this past September. Nearly 90% of the patients were free from 24-week confirmed disability progression after six years of continuous treatment. Six years! The relapse rate seen in the six-year BRIUMVI treatment translates into one relapse occurring in every 83 years of treatment. Importantly, no new safety signals emerged. On the R&D front, we advanced our phase III ENHANCE study evaluating consolidation of the day one and day 15 BRIUMVI infusions into a single 600 milligram dose. Enrollment is complete. We expect top-line data mid-year with a potential 2027 launch of this consolidated treatment schedule. If successful, this could meaningfully simplify the treatment experience. We believe effective therapies should not only work well, but be as convenient as possible for patients. Michael WeissChairman and CEO at TG Therapeutics00:03:54Which brings me to our subcutaneous program. We're developing a self-administered, at-home sub-Q BRIUMVI to be delivered via an auto-injector. Our phase III study is evaluating two dosing schedules; every two months and quarterly administration. The trial is now approximately 75% enrolled, and we're targeting pivotal top-line data later this year or early next year, with a potential 2028 launch. We see this program as having significant commercial potential. The sub-Q portion of the anti-CD20 market is substantial, and being able to compete in this space, we believe, could nearly double our total addressable market opportunity. Beyond MS, we are actively advancing plans to explore BRIUMVI in additional autoimmune indications, including having treated a series of myasthenia gravis patients in a phase I study. Finally, azer-cel, our allogeneic anti-CD19 CAR T, is being studied in patients with progressive MS. It's still early, but momentum is building. Michael WeissChairman and CEO at TG Therapeutics00:04:59Our clinical trial sites are identifying patients quickly. In fact, demand is exceeding available trial slots. That tells us something important. There's a real unmet medical need. We look forward to sharing updates from this program later this year. Turning to some financials. I'll leave the details to Adam and Sean, but suffice to say, we expect to continue generating positive cash flow in 2026 and beyond, which gives us a rare financial flexibility within the biotech universe. We've been clear about our capital priorities: invest to maximize the multi-billion dollar BRIUMVI opportunity, expand the pipeline judiciously for sustained future growth, repurchase shares when we believe TG is materially undervalued, and otherwise allocate capital in ways that generate long-term returns. Michael WeissChairman and CEO at TG Therapeutics00:05:51With respect to share buybacks, we completed our first $100 million share repurchase program, and the board authorized an additional $100 million last year. At current levels, we view our shares as significantly undervalued relative to the cash flow profile we expect over the coming years, and we will not hesitate to act accordingly, including adding leverage to reduce our share count. To be clear, we purchase shares to create long-term value, not for the optics. Before closing, I want to touch on something I'm personally very proud of. Many of you saw Christina Applegate launch Next in MS during Super Bowl LX. We are honored to partner with her on this platform. Next in MS is about honest, unfiltered conversations, about life with MS, about difficult realities, about resilience beyond treatment decisions. Michael WeissChairman and CEO at TG Therapeutics00:06:42We're not just commercializing BRIUMVI, we're building the MS company that shows up for patients beyond the prescription. To close, at TG, our mission remains simple: deliver meaningful therapies, simplify treatment, create lasting value for patients and shareholders. I'll now turn the call over to Adam Waldman, our Chief Commercial Officer, for a detailed commercial update. Adam, go ahead. Adam WaldmanCCO at TG Therapeutics00:07:09Thanks, Mike, good morning, everyone. 2025 was a year of continued acceleration for BRIUMVI, and we closed the year with another strong quarter of execution and growth, further expanding our position in the RMS market. For the fourth quarter of 2025, we delivered U.S. net sales of $183 million and continued sequential expansion versus Q3. For the full year, BRIUMVI U.S. net revenue reached $594 million, reflecting sustained momentum built on the strong commercial foundation established in the first three years of launch. Growth throughout the year was driven by consistent and increasing year-over-year new patient starts, continued expansion of our prescriber base, better than expected persistence, greater depth within high-volume infusion accounts. Importantly, growth was broad-based across both academic and community settings, reflecting rising physician confidence and expanding utilization. Adam WaldmanCCO at TG Therapeutics00:08:00BRIUMVI continues to strengthen its competitive position within a large and growing anti-CD20 market. Within the IV anti-CD20 segment, we continue to gain dynamic share. Physicians remain focused on proven efficacy, long-term safety experience, and operational efficiency. BRIUMVI's one-hour, twice-yearly maintenance infusion profile, supported by multiyear data, continues to resonate in a competitive environment. We're seeing a balanced mix of treatment-naive and switch patients, reinforcing both the breadth of the opportunity and the continued expansion of our footprint within the class. Our execution remains strong across all commercial functions. TG is emerging as a leader in the therapeutic category. As the franchise continues to scale, we have continued to invest behind the business. During 2025, we expanded our field organization to deepen coverage in high-opportunity geographies and broaden our reach among community neurologists and independent infusion centers. Adam WaldmanCCO at TG Therapeutics00:09:00That expanded footprint is driving increased prescriber engagement and positions us to accelerate further penetration in 2026. We also expanded our direct-to-patient engagement efforts during the year. In addition to our national BRIUMVI campaign, as Mike mentioned, we recently announced our partnership with Christina Applegate to launch NextInMS.com, a new educational platform designed to provide resources and information to individuals living with RMS and their caregivers. Christina's long-standing advocacy within the MS community brings credibility and visibility to broader conversations around navigating life with MS. Through Next in MS, our focus is on education, empowerment, and encouraging informed dialogue between patients and their healthcare providers. Adam WaldmanCCO at TG Therapeutics00:09:51As BRIUMVI continues to scale, we believe it's important to engage thoughtfully and meaningfully in, within the MS community, and this partnership reflects our growing leadership, position in the space and our long-term commitment to supporting the MS community. As we look to 2026, we are reaffirming our previously issued full-year U.S. BRIUMVI net revenue guidance of $825 million-$850 million, with total global revenue, at $875 million-$900 million. Our outlook reflects continued growth, driven by expanding prescriber adoption, increasing depth within existing accounts and ongoing share gains, and a growing installed base of patients with strong persistence on therapy. We've entered 2026 with real momentum. New patient starts are tracking to our strongest levels since launch. Adam WaldmanCCO at TG Therapeutics00:10:40Physician confidence continues to build, and our share trajectory within the IV anti-CD20 segment remains favorable. Importantly, after operating alongside competitive entrants for several quarters, BRIUMVI has demonstrated that it can compete effectively and continue to expand its position within the class. Turning to the first quarter, and based on the strong demand trends we're seeing early in the year, we expect U.S. revenue to grow sequentially over Q4 levels to approximately $185 million-$190 million, even after accounting for typical seasonal headwinds. As we have mentioned previously, the first quarter generally reflects routine factors such as benefit reverifications and gross and net variability driven by deductible resets, which can influence the timing of net revenue early in the year. Adam WaldmanCCO at TG Therapeutics00:11:31These dynamics are consistent with what we've seen historically in the category and are fully incorporated into our full year guidance. We also expect ex-U.S. revenue to be in the range of $5 million-$10 million for the first quarter. Taken together, the strength of demand and continued share expansion gives us confidence in our reaffirmed guidance and our ability to drive meaningful growth in 2026. To summarize, we have delivered another year of strong growth in 2025. We continue to gain share in a competitive IV anti-CD20 market. We have invested meaningfully in field expansion and direct-to-consumer initiatives to support the next phase of growth. We are off to a very strong start in 2026, tracking to record new patient enrollments entering the year. Adam WaldmanCCO at TG Therapeutics00:12:19BRIUMVI is now a scaled and expanding franchise. We believe the commercial platform we've built positions us well to continue driving meaningful growth in the year ahead. With that, I'll turn it over to Sean to walk through the financials. Sean PowerCFO at TG Therapeutics00:12:34Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we released our fourth quarter and full year 2025 financial results, which are available in the Investors and Media section of our website. I'll begin with a discussion of our revenue for the fourth quarter and full year, which Adam briefly touched on. We are pleased to report U.S. BRIUMVI net product revenue of $182.7 million during the fourth quarter. Total net product revenue for the quarter was $189.1 million, which includes $6.4 million of product revenue related to sales to our partner, Neuraxpharm, in support of ex-U.S. commercialization. Sean PowerCFO at TG Therapeutics00:13:19For the full year 2025, global revenue was approximately $616 million, predominantly comprised of $594 million in U.S. BRIUMVI net products revenue, $12.8 million in revenue from products supplied to Neuraxpharm, and $9.4 million in royalty and other revenue. Our gross margin for the quarter was slightly below typical as a result of timing of sales to our ex-U.S. partner and a one-time inventory reserve. Shifting to operating expenses, which we define as R&D and SG&A, excluding non-cash comp. Full year 2025 expenses totaled approximately $328 million, in line with our prior guidance of $300 million-$320 million. The modest variance was driven primarily by incremental manufacturing and development costs related to subcutaneous BRIUMVI and continued commercial investment. Sean PowerCFO at TG Therapeutics00:14:21Revenue growth significantly exceeded the increase in operating expenses, resulting in operating income of $123 million for the year. For the fourth quarter, net income was $23 million, or $0.14 per diluted share. For the full year 2025, net income totaled $447.2 million, or $2.77 per diluted share, compared to $23.4 million, or $0.15 per diluted share in 2024. As a reminder, 2025 results, including non-recurring income tax benefit of approximately $340 million, which relates primarily to the release of our deferred tax asset valuation allowance in the third quarter. Sean PowerCFO at TG Therapeutics00:15:12Turning to our balance sheet and capital position, we ended the year with more than $600 million in current assets, approximately $200 million in cash equivalents and investment securities, $300 million in accounts receivable and $140 million in inventory. During the year, we completed our previously authorized $100 million share repurchase program, purchasing approximately 3.5 million shares at an average price of $28.55 per share. The board has since authorized an additional $100 million share repurchase program, reflecting continued confidence in our long-term outlook. Looking ahead to 2026, we expect full-year operating expenses of approximately $350 million, excluding non-cash comp, plus approximately $100 million in expenses associated with subcutaneous BRIUMVI manufacturing and secondary manufacturer startup activities. Sean PowerCFO at TG Therapeutics00:16:15These costs run through R&D today, but if the programs are successful, the related inventory would be sold in future periods with little to no associated cost of goods, as the manufacturing expense has already been recognized, positively impacting gross margin in future periods. In summary, 2025 represented a year of strong execution for TG. We delivered substantial revenue growth, generated meaningful operating income, and positioned the company for continued expansion in 2026. With that, I will now turn the call back over to the conference operator to begin the Q&A. Operator00:16:58Thank you. We will now conduct 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 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one at this time. One moment while we pull for our first question. The first question comes from Michael Schmidt with Evercore ISI. Please proceed. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:17:33Hi, guys. Thanks so much for taking my questions. Two for me. Roche has recently highlighted accelerating sub-Q uptake in community practices, and Novartis continues to emphasize strong growth in the self-administered first-line use. You've described broad momentum across academic and community settings in the HCP administered segment. My question is, can you help us think about how those dynamics fit together and where you're currently seeing the strongest incremental momentum by site of care? I have a follow-up. Michael WeissChairman and CEO at TG Therapeutics00:18:10Sure. Thanks for the question. Adam, you want to go ahead? Adam WaldmanCCO at TG Therapeutics00:18:15Yeah, sure. Thanks for the question, Mike. You know, listen, we've now operated alongside the new entry from Roche for several quarters now. We continue to seek, you know, shares gains in the IV segment. Physicians seem to be continue to be driven by clinical data, long-term data, operational considerations. It seems like the majority of the Zeposia business seems to be coming from Ocrevus IV. Importantly, we're not seeing any decreases in the switches from Ocrevus to BRIUMVI, so that's an important factor, too. In terms of, you know, what's driving our share, we're seeing growth across both private practice and academic centers. Adam WaldmanCCO at TG Therapeutics00:19:03We think it's the durability of the clinical profiles, as Mike mentioned, the six-year data, especially the, you know, the safety data within there and the efficacy data. We continue to believe the operational advantages of BRIUMVI, the one-hour infusion, twice a year, are relevant for patients in infusion centers. We continue to expand prescriber breadth and depth with our expansion of our, you know, our field force. I think, you know, we're seeing great momentum, and as I mentioned, the underlying demand is very strong. Enrollments are tracking to the highest since launch. You know, we continue to see share gains across the board, across patient types, across sites of care. Importantly, also, we see very strong persistence. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:19:51Overall, really strong, and, you know, the fundamentals are great. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:19:57Very helpful. My follow-up question is on gross to net. You previously noticed that gross net can fluctuate with site of care mix, particularly in hospital exposure. As growth evolves across channels, are you seeing any meaningful change in gross to net assumptions, or does your prior framework still hold? Adam WaldmanCCO at TG Therapeutics00:20:19Yeah, you know, as I mentioned in the in the prepared remarks, gross to net can vary quarter to quarter. In Q1, gross to net is influenced by deductible resets and high utilization of co-pay programs. Consistent with what we've seen historically, does not represent a structural change in, you know, how we think about gross to net. It's a, you know, it's a, you know, a Q1 dynamic. Our full year guide reflects the net revenue profile for this year. It is a Q1 dynamic that seems to be consistent with what we see across the CD20 space, also other specialty products, and it's fully baked into our full year guidance. I hope that answers the question. Michael SchmidtManaging Director and Equity Research Analyst at Evercore ISI00:21:03Thanks so much. Operator00:21:06The next question comes from Tara Bancroft with TD Cowen. Please proceed. Tara BancroftDirector and Biotech Senior Research Analyst at TD Cowen00:21:11Hi, good morning. I'm curious to hear your thoughts around positioning now that you know, you're several years into this launch, but, you know, guidance for Q1 and the year are pretty conservative. I was hoping you could give us some more detail on the proportion of new versus switch patients and how much revenue now is from patients that are remaining on treatment for these extended periods of time. Whether new patient starts are still growing or leveling off, and why? Thanks. Michael WeissChairman and CEO at TG Therapeutics00:21:44Thanks, Tara. Adam, it's all you still. Go ahead. Adam WaldmanCCO at TG Therapeutics00:21:49Yeah, thanks for the question, Tara Bancroft. You know, listen, I think I'll just reiterate what we're seeing. The majority, you know, we're seeing record new patient enrollments here. We're still seeing growth. We're seeing great share gains in the IV segment. I think that's being driven by the things that I mentioned, durability of the clinical profile, the six-year data, the operational advantages. Our investment in both the expansion of our field force, it could very well be our DTC efforts, although hard to, you know, single out a single factor here. All these things, I think, are leading to continued confidence in the product across the board, and that's why we're seeing such a great demand that we're seeing right now. Adam WaldmanCCO at TG Therapeutics00:22:33As far as new versus switch, you know, I mentioned a couple quarters ago, the business becomes more predictable as we've now walked into more repeat patients. We are seeing more and more repeat patients as a bigger part of our business, as that, you know, patients continue to pancake from quarter to quarter and stay on therapy for long periods of time. As I mentioned before, also, our persistence is quite strong. We're seeing patients staying on therapy for it looks like out to week 48, week 72, week 96 seems very good. All those things are leading to growth. Adam WaldmanCCO at TG Therapeutics00:23:17We do expect full, you know, we do expect growth in 2026 and meaningful growth in the in our guidance. Tara BancroftDirector and Biotech Senior Research Analyst at TD Cowen00:23:27Okay, great. Thank you. Operator00:23:32The next question comes from Prakhar Agrawal with Cantor Fitzgerald. Please proceed. Prakhar AgrawalSenior Biotech Analyst at Cantor Fitzgerald00:23:38Hi, congrats on the quarter, and thank you for taking my questions. Maybe just to follow up on the new patient start. Adam Waldman, you said you're seeing a good growth in new patient starts, but I'm trying to connect the dots between your commentary as well as what's implied in the guidance, because based on our math, the guidance would imply a more modest year-on-year growth on new patient start. How much conservatism is baked into the guidance, or should we expect about higher growth to net for full year 2026? Secondly, how much incremental investments would you need for the sub-Q launch? What would be the plans to commercialize sub-Q BRIUMVI ex-U.S.? Given that it seems to be a large market for drugs like MS drugs, there could be a lot of value there. Thank you. Adam WaldmanCCO at TG Therapeutics00:24:29Yeah. Mike, you want me to continue to go here? Michael WeissChairman and CEO at TG Therapeutics00:24:33Yeah, why don't you start off? Go ahead. Adam WaldmanCCO at TG Therapeutics00:24:36Yeah. Yeah. I mean, look, we're early in the year here. Like I said, we're seeing a strong start to the year. We're early here. We'll continue to update the guidance as we see fit, as we continue to get more time, see how we do throughout the year. It's, of course, you know, possible that we could see outperformance, that could come from, you know, continued new patient starts. We could see incremental share gains. We could see, you know, better than expected persistence. That's, you know. We're being somewhat conservative here, but, you know, so far the year's starting strong, but we're, you know, again, we're only in February. We'll see how that goes. Adam WaldmanCCO at TG Therapeutics00:25:19You know, in Q1, we're seeing, you know, just the disconnect in Q1, Prakhar, to your question, strong, new patient growth. However, you know, you do face the Q1 issues and headwinds that I described on gross to net and benefit reverification. Mike, I don't know if you want to take the sub-Q question. Michael WeissChairman and CEO at TG Therapeutics00:25:40Sure. Yeah. I mean, in terms of incremental investment, Prakhar, you can answer this as well as me, but, you know, over-overlap between our current field force for IV to subQ is I think about 80%. There's not a huge incremental cost, there'll obviously be some incremental marketing costs associated with it, but overall, it's not a huge incremental, investment to launch subQ in the U.S. As for ex-U.S., we expect, our partners at Neurax will opt into that program, when offered it, we'll work with them on the ex-U.S., strategy at that point. Prakhar AgrawalSenior Biotech Analyst at Cantor Fitzgerald00:26:25Thank you. Michael WeissChairman and CEO at TG Therapeutics00:26:27Thank you. Operator00:26:29The next question comes from Corinne Johnson, Goldman Sachs. Please proceed. Corinne JohnsonVice President of Equity Research at Goldman Sachs00:26:35Good morning. Maybe continue on the conversation on sub-Q. Some of the competitors in the space have started providing color on the role they think a sub-Q offering could play over time with respect to IV versus sub-Q share. I guess, what is your perspective there, particularly given the variety of dosing options within sub-Q that could be coming over the next couple of years, including obviously BRIUMVI? Thanks. Michael WeissChairman and CEO at TG Therapeutics00:26:58Sure. I'll give it a start, Adam, to supplement, if you like. You know, look, the sub-Q portion of the market has been relatively stable, for a while, I think 35% to maybe 40%. It fluctuates up and down quarter to quarter. You know, long term, you know, the more options that are available creates more, you know, energy in that space and more people marketing in that space. I do believe that over time, with new options available, that space can expand and probably will expand. To what extent is hard to predict at this moment, but I do think there's probably some, forces that will push people toward, towards sub-Q at home over time. Yeah, I do think that market will continue to, grow. Adam, any additional thoughts? Adam WaldmanCCO at TG Therapeutics00:27:52No, that's perfect, thanks. Corinne JohnsonVice President of Equity Research at Goldman Sachs00:27:55Thanks. Michael WeissChairman and CEO at TG Therapeutics00:27:57Thank you. Operator00:28:01The next question comes from Brian Cheng with JPMorgan. Please proceed. Brian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.00:28:08Hey, guys. Thanks for taking our question this morning. Just looking at the existing sales force, is there any potential need for a refocus of their goal this year? Are there pocket of opportunities that you think might be more important this year, just given more adoption on the sub-Q side? On a related note, how should we think about the expenses projection related to the DTC campaign that you have set up for this year? What might be two of the step up that we expect? Thank you. Michael WeissChairman and CEO at TG Therapeutics00:28:45Thanks, Brian. Adam, you want to lead us off here? Adam WaldmanCCO at TG Therapeutics00:28:50Sure. Yeah, thanks for the question, Brian. You know, we, as I've mentioned before, we continue to take a strategic expansion approach to our field force. We have continued to add people as we've seen opportunities to do so. We're looking at it strategically. We add people where we see opportunity, and continue to hire the best people that we can find in the area. As far as a new goal, you know, I don't, I don't know that it needs a new goal. I think we have a, you know, a pay-for-performance culture, and an accountable culture. We have, we've hired the best people in the industry. You know, this team is fantastic, and they continue to deliver on what we've asked them to do. Adam WaldmanCCO at TG Therapeutics00:29:42I don't think we need a new goal. I think we have a great team. I'm very confident in the, in the commercial, the commercial functions. As I mentioned, I think they're doing an excellent job. Brian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.00:29:53Great. Thank you. Operator00:29:57The next question comes from William Wood, with B. Riley. Please proceed. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:30:03Hi, thank you for taking our questions. Thinking about some of your sub-Q and phase III that's going on currently, I'm just curious when we might actually see, or if there's a chance that we might see any sub-Q bioequivalence data generated. How we can sort of think about that phase III readout later this year. Also in terms of some of the earlier stage programs, I know you've got phase I ongoing in myasthenia gravis. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:30:32Just curious if and when we might expect to see some of these earlier stage data from the earlier stage programs, any of that reading out later this year at conferences? Michael WeissChairman and CEO at TG Therapeutics00:30:44Sure. Thanks for the question, William. In terms of sub-Q, yes, as we discussed, phase III is approximately 75% enrolled. We continue to be excited about that program, and it's the opportunity for us there. Phase III data is expected later this year or early next year. In terms of the phase I bioequivalence data, you know, it's been coming in. The study is actually, I think, just about to close formally. There's overlap between the phase III and the phase I, just the follow-up, and all those kinds of things. The phase I is, I think, just about closing up or maybe it's not there yet, but getting close. Michael WeissChairman and CEO at TG Therapeutics00:31:25We'll take a look at the timing of conferences and the timing of phase III data and see if it makes sense to actually put the phase I data out or not, based on timing of where we are at the phase III and the conference schedule that's available once that data is fully evaluated in presentable format. The answer is, I don't know as of yet. Like I said, you know, based on the preliminary data, we're feeling very good about the program and very excited about the phase III outcome that will be later this year. In terms of phase I-MG, I have not talked to the team yet about what their plans are for presenting that information. Michael WeissChairman and CEO at TG Therapeutics00:32:06Anecdotally, I know the study, the patients who've been treated with MG look quite good in terms of their response to the drug, which I don't think is much of a surprise to anybody. I'll check back with the team and I'll be able to give some more guidance later on that once I find out what their plans are. William WoodHealthcare Equity Research Analyst at B. Riley Securities00:32:27Got it. Thank you very much. Thanks for answering our questions. Michael WeissChairman and CEO at TG Therapeutics00:32:31Thank you. Operator00:32:33The next question comes from Emily Bodnar with H.C. Wainwright. Please proceed. Emily BodnarVice President of Equity Research at H.C. Wainwright00:32:38Hi, good morning. Thanks for taking the questions. In terms of the ENHANCE trial and launching that next year, can you just talk about how you think about that from a market perspective, and if you see any potential for kind of incremental revenue growth with implementing that launch? Then maybe if you could just talk a bit about some early metrics that you're tracking with the DTC launch and the Next in MS program. Thanks. Michael WeissChairman and CEO at TG Therapeutics00:33:08Sure. Thanks for the question, Emily. In terms of the ENHANCE trial and launch, and incremental potential from that, I'll take a crack at it, and then please jump in. You know, we've done some market research. Generally speaking, it's extremely positive feedback on eliminating that second dose. The convenience factor for both patient and for centers is viewed very high in the research we're doing. Anecdotally, I've personally been in advisory boards recently, where people are even more enthusiastic than they've previously been about reducing that first dose. In terms of incremental, you know, market share gains, I think from our research and from, you know, the anecdotal experience that we have, we do believe that it will help us continue to gain market share gains in this area. Michael WeissChairman and CEO at TG Therapeutics00:34:07You know, again, it's just, every time we make it easier, it's just, it's better. In terms of the other side of it, in terms of switches, people are excited about it to use this, you know, on label for switches, which we think will be helpful there. Generally speaking, if you're looking at, you know, going on IV Ocrevus or IV BRIUMVI, you now have another reason or another convenience reason to go on to BRIUMVI, eliminating that first dose, which they will still have two doses up front for their IV, plus the much longer infusion. Yeah, we do think that'll have a positive impact, and we're looking forward to that launch. Adam, anything more on that topic? Adam WaldmanCCO at TG Therapeutics00:34:54No, I think you covered it. That was great. Michael WeissChairman and CEO at TG Therapeutics00:34:57Okay. The second part of the question was early metrics on DTC. I know that's one of Adam's favorite topics, so I'll hand it off to him. Adam WaldmanChief Commercialization Officer at TG Therapeutics00:35:08No, thanks for the question, Emily, and asking about our partnership with Christina on Next in MS. You know, as I mentioned, we view these efforts as building long-term category leadership. The feedback from customers and patients and advocacy groups has been incredibly positive. So far, obviously, we're looking at, you know, in terms of metrics that you asked about, you know, the engagement with the content has been has exceeded our expectations. We're looking at, you know, the number of people who sign up on our website, the number of website visits, number of sessions. We'll continue to track it, but so far, everything has exceeded our expectations, and the engagement with the materials has been fantastic. Emily BodnarVice President of Equity Research at H.C. Wainwright00:35:53Okay. Thank you. Michael WeissChairman and CEO at TG Therapeutics00:35:56Thanks, Emily. Appreciate it. Operator00:35:58Thank you. At this time, I would like to turn the call back to Mike Weiss for closing comments. Michael WeissChairman and CEO at TG Therapeutics00:36:03Great. Thank you, operator, and thanks again, everyone, for joining us. 2025 was a very strong year for us. 2026, we expect to be even stronger, including a number of very exciting catalysts, including the top-line data from our ENHANCE trial, some preliminary data from azer-cel, then perhaps the biggest one of all, at the end of the year or early next year, pivotal data from subcutaneous BRIUMVI program. To our TG employees, thank you always for your dedication to those living with MS. To the healthcare providers, individuals with MS, and their families, thank you for your trust. To our long-term shareholders, thank you for recognizing the potential of what we are building here at TG. We're just getting started. Have a great day. Operator00:36:51Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.Read moreParticipantsExecutivesAdam WaldmanCCOAdam WaldmanChief Commercialization OfficerJenna BoscoCCOMichael WeissChairman and CEOSean PowerCFOAnalystsBrian ChengVice President and Equity Research Analyst at JPMorgan Chase & Co.Corinne JohnsonVice President of Equity Research at Goldman SachsEmily BodnarVice President of Equity Research at H.C. WainwrightMichael SchmidtManaging Director and Equity Research Analyst at Evercore ISIPrakhar AgrawalSenior Biotech Analyst at Cantor FitzgeraldTara BancroftDirector and Biotech Senior Research Analyst at TD CowenWilliam WoodHealthcare Equity Research Analyst at B. Riley SecuritiesPowered by