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TGTX

TG TherapeuticsA
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-05-27
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Earnings documents stored for TGTX.

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Investor releaseQuarter not tagged2026-05-27

TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial

GlobeNewswire

Phase 3 trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI Day 1 and Day 15 initiation dosing and a new single infusion on Day 1 only Safety and tolerability of the consolidated first infusion were consistent with the established BRIUMVI safety profile Supplemental BLA filing targeted 2H-2026 NEW YORK, May 27, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved initiation dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Topline outcomes from the ENHANCE Phase 3 study are highlighted below, and full results are expected to be presented at an upcoming medical meeting. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated: “We are very pleased to share these positive results from our ENHANCE Phase 3 trial. By eliminating the need for a second infusion visit two weeks after treatment initiation, this streamlined dosing regimen has the potential to accelerate time from prescription to treatment and reduce scheduling burdens at busy infusion centers. If this consolidated dosing is approved, BRIUMVI would be the first and only IV anti-CD20 for which therapy can be initiated with a single infusion.” Mr. Weiss continued, “People living with RMS already manage significant complexity in their daily lives, and we believe treatment simplicity matters. These results reflect our broader commitment not only to developing effective therapies, but also to improving the treatment experience for patients and healthcare providers. We look forward to engaging with regulatory authorities regarding these data, with the goal of submitting a supplemental BLA in the second half of 2026.” OVERVIEW OF THE ENHANCE PHASE 3 STUDY AND KEY FINDINGS Design: The Phase 3b ENHANCE trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the pharmacokinetics, safety, and MRI outcomes of a consol...

Investor releaseQuarter not tagged2026-05-13

TG Therapeutics' (NASDAQ:TGTX) Earnings Aren't As Good As They Appear

Simply Wall St.

After announcing healthy earnings, TG Therapeutics, Inc.'s (NASDAQ:TGTX) stock rose over the last week. However, we think that shareholders should be aware of some other factors beyond the profit numbers. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. As finance nerds would already know, the accrual ratio from cashflow is a key measure for assessing how well a company's free cash flow (FCF) matches its profit. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. While having an accrual ratio above zero is of little concern, we do think it's worth noting when a company has a relatively high accrual ratio. That's because some academic studies have suggested that high accruals ratios tend to lead to lower profit or less profit growth. TG Therapeutics has an accrual ratio of 0.93 for the year to March 2026. Statistically speaking, that's a real negative for future earnings. And indeed, during the period the company didn't produce any free cash flow whatsoever. In the last twelve months it actually had negative free cash flow, with an outflow of US$14m despite its profit of US$461.9m, mentioned above. We also note that TG Therapeutics' free cash flow was actually negative last year as well, so we could understand if shareholders were bothered by its outflow of US$14m. However, as we will discuss below, we can see that the company's accrual ratio has been impacted by its tax situation. This would certainly have contributed to the weak cash conversion. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. In addition to the notable accrual ratio, we can see that TG Therapeutics received a tax benefit of US$340m. This is meaningful because companies usually pay tax rather than receive tax benefits. Of course, prima facie it's great to receive a tax benefit. However, our data indicates that tax benefits can temporarily boo...

Investor releaseQuarter not tagged2026-05-08

TGTX Q1 Earnings Miss, Sales Rise Y/Y, Stock Up on Raised 2026 View

Zacks

TG Therapeutics TGTX reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi (ublituximab-xiiy). The figure beat the Zacks Consensus Estimate of $199 million. Briumvi, an anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) in December 2022. The drug is also approved in the European Union, the United Kingdom, Australia, Switzerland and certain other countries. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting a 68.2% year-over-year increase. Total product revenues included sales of Briumvi to TGTX’s licensing partner, in ex-U.S. markets, Neuraxpharm, of $6.5 million. TG Therapeutics has an agreement with Neuraxpharm Pharmaceuticals for the ex-U.S. commercialization of Briumvi, wherein the company is entitled to receive payments upon the achievement of certain commercial milestones and targets. Briumvi's net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 m...

Investor releaseQuarter not tagged2026-05-07

TG Therapeutics Q1 Earnings Call Highlights

MarketBeat

The Most Shorted Stocks in June: Hold, Short, or Squeeze? TG Therapeutics (NASDAQ:TGTX) reported first-quarter 2026 results that management characterized as “record-setting” across most of its commercial metrics, led by sales of multiple sclerosis therapy BRIUMVI. The company posted U.S. BRIUMVI net product revenue of approximately $195 million, exceeding its prior guidance range of $185 million to $190 million, and said total net product revenue reached $201 million when including product sales to its ex-U.S. partner Neuraxpharm. Chairman and CEO Michael Weiss said the quarter reflected “consistency and durability” across the business, noting that global revenue exceeded $200 million and that the company expects to approach a $1 billion annualized run rate before year-end. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? TG Therapeutics Stock 300% Rally Has Legs Yet Chief Commercial Officer Adam Waldman said U.S. net revenue grew 63% year-over-year and represented the “12th consecutive quarter of sequential growth since launch.” He added that the company saw record new patient enrollments, with March described as its highest month ever. Following the stronger quarter, Waldman said TG Therapeutics is raising full-year 2026 U.S. revenue guidance to $885 million to $900 million and is providing second-quarter guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. CFO Sean Power also said the company raised its full-year total global revenue guidance to approximately $925 million. → A Prada Payday: Is AMC Back in Style? Waldman said more than 25,000 patients have been prescribed BRIUMVI globally, framing the milestone as evidence the company is moving beyond “early adoption” and building an “installed base” in a recurring, twice-yearly dosing model. He said persistence has been “strong,” and later added in Q&A that trends have been “better than expected” as patients move into their second year of treatment, though he emphasized it is still early and the company will continue to monitor as data matures. Waldman also pointed to direct-to-consumer (DTC) outreach as a contributor to awareness, saying the company has been investing over the last year and is encouraged by “markers and indicators of success,” with more patients arriving at physicians’ offices already informed about BRIUMVI. → Insider Sales: Top AST SpaceMobile Insider...

Investor releaseQuarter not tagged2026-05-07

Dow Jones Futures Rise, Oil Prices Fall On Iran-Deal Hopes, Nvidia Leads New Buys; ARM Is Earnings Mover

Investor's Business Daily

The S&P 500 and Nasdaq hit new highs on Iran deal hopes. Nvidia leads new buys with Arm a big earnings mover late.

Investor releaseQuarter not tagged2026-05-07

TG Therapeutics, Inc. Q1 2026 Earnings Call Summary

Moby

Achieved record-setting Q1 performance with $195 million in U.S. BRIUMVI revenue, driven by a growing installed base and better-than-expected patient persistence. Transitioned from an early adoption phase to a recurring treatment model where each new patient cohort builds upon an expanding base of predictable demand. Established BRIUMVI as the leading anti-CD20 therapy by dynamic share in private practices with infusion capabilities, attributed to operational simplicity and a 1-hour infusion profile. Observed a rising mix of treatment-naive patients, which management views as the strongest leading indicator of long-term market dominance and brand loyalty. Leveraged a lean commercial engine to drive operating income growth that significantly outpaces expense growth, demonstrating scalable operating leverage. Maintained a disciplined capital allocation strategy, repurchasing $100 million in stock during the quarter based on management's view that the company remains undervalued. Raised full-year global revenue guidance to approximately $925 million., reflecting confidence in sustained new patient demand and high retention rates. Anticipating top-line Phase III data from the ENHANCE study in the coming weeks, which aims to simplify the IV dosing schedule by eliminating the day 15 infusion. The company is targeting the subcutaneous patient-administered segment, which represents roughly 35% of the anti-CD20 market and would allow the franchise to reach patients who prefer or require at-home self-administration. Expanding the 'pipeline within a product' strategy by initiating a Phase II registration-directed study in Myasthenia Gravis and exploratory work in treatment-resistant schizophrenia. Advancing the Azer-cel allogeneic CAR-T program in progressive MS, with plans to share biomarker and safety updates later this year as dose escalation continues. Incurred a one-time $9.2 million charge related to the refinancing of the Blue Owl facility, intended to enhance long-term financial flexibility for share buybacks and M&A. Directing approximately $100 million toward subcutaneous manufacturing as part of the current full-year expense guidance. and secondary manufacturer start-up activities to ensure supply chain redundancy. Noted that while gross-to-net discounts may fluctuate quarterly, they are expected to average approximately 65% for the full year. Acknowledged t...

Investor releaseQuarter not tagged2026-05-07

TG Therapeutics (TGTX) Q1 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. Wednesday, May 6, 2026 at 8:30 a.m. ET Chief Executive Officer — Michael Weiss Chief Commercialization Officer — Adam Waldman Chief Financial Officer — Sean Power Need a quote from a Motley Fool analyst? Email [email protected] Michael Weiss: Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone, but because of the consistency and durability we're now seeing across the business. Let me start with the commercial side. At a high level, Q1 was a record-setting quarter across nearly every metric we track. The momentum puts us in a very strong position as we move through the rest of the year. From a revenue standpoint, we delivered approximately $195 million in U.S. BRIUMVI net product revenue in quarter 1, ahead of our guidance of $185 million to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone. And as we move toward $1 billion annualized run rate expected before year-end, we continue to believe we are still early in the BRIUMVI adoption curve, making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today. Physicians are increasingly recognizing the value of BRIUMVI, not just on efficacy, but on the overall treatment experience, thus translating into durable, repeatable growth. And importantly, the data continues to support that differentiation. Earlier this year, we were pleased to see our 5-year follow-up data from the ULTIMATE I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BRIUMVI along with a consistent safety and tolerability profile over time. At AAN earlier this month, we continue to build on that story with real-world data demonstrating sustained and rapid B-cell depletion, low annualized relapse rates maintained over time and continued evidence of a favorable infusion experience and tolerability profile. And for the first time, we presented prospective data from patients who switched from a prior anti-CD20 therapy to BRIUMVI, which showed improvement in patient-reported wearing off symptoms, sometimes referred to as the clot gap after switching to BRIUMVI. Given that meaningful number of patients report this wearing off effect, the potential to address it...

Investor releaseQuarter not tagged2026-05-06

TG Therapeutics Q1 Earnings, Revenue Rise; Lifts 2026 Revenue Guidance

MT Newswires

TG Therapeutics (TGTX) reported Q1 earnings Wednesday of $0.12 per diluted share, up from $0.03 a ye

Investor releaseQuarter not tagged2026-05-06

TG Therapeutics (TGTX) Q1 Earnings Lag Estimates

Zacks

TG Therapeutics (TGTX) came out with quarterly earnings of $0.17 per share, missing the Zacks Consensus Estimate of $0.23 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -26.88%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.35 per share when it actually produced earnings of $0.14, delivering a surprise of -60%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $204.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 2.81%. This compares to year-ago revenues of $120.86 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have added about 21.1% since the beginning of the year versus the S&P 500's gain of 6%. While TG Therapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the c...

Investor releaseQuarter not tagged2026-05-06

TG Therapeutics: Q1 Earnings Snapshot

Associated Press

MORRISVILLE, N.C. (AP) — MORRISVILLE, N.C. (AP) — TG Therapeutics Inc. (TGTX) on Wednesday reported first-quarter net income of $19.8 million. The Morrisville, North Carolina-based company said it had net income of 12 cents per share. Earnings, adjusted to extinguish debt, were 17 cents per share. The results missed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research was for earnings of 23 cents per share. The biopharmaceutical company posted revenue of $204.9 million in the period, topping Street forecasts. Three analysts surveyed by Zacks expected $199.3 million. TG Therapeutics expects full-year revenue of $925 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on TGTX at https://www.zacks.com/ap/TGTX

Investor releaseQuarter not tagged2026-05-06

TG Therapeutics Reports First Quarter 2026 Financial Results and Raises BRIUMVI Revenue Guidance

GlobeNewswire

First quarter 2026 total global revenue of approximately $205 million, including BRIUMVI U.S. net revenue of approximately $195 million Raises full year 2026 total global revenue target to approximately $925 million and raises full year 2026 BRIUMVI U.S. net product revenue target to $885-900 million Conference call to be held today, Wednesday, May 6, 2026, at 8:30 AM ET NEW YORK, May 06, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the first quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “We are off to a strong start in 2026, with BRIUMVI performance exceeding expectations and momentum continuing to build. Growth is being driven by strong underlying demand, record new patient starts, and consistent commercial execution— reinforcing our belief that we remain early in the adoption curve for BRIUMVI. Based on this performance, we are significantly increasing our full-year U.S. BRIUMVI revenue guidance to $885-900 million and continue to see the brand as having a multi-billion-dollar potential before considering the impact of a subcutaneous BRIUMVI currently under development. With multiple near-term clinical catalysts and ongoing efforts to expand the franchise, we believe BRIUMVI is well-positioned to become a leading therapy in MS and a durable, long-term growth driver for TG.” Recent Highlights & Developments BRIUMVI® (ublituximab-xiiy) Commercialization BRIUMVI U.S. net product revenue of $194.8 million for the first quarter 2026, representing approximately 63% quarterly growth over the same period last year BRIUMVI Data Presentations & Publications Published two articles in medical journals: March 2026: “Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis”, published in Neurology and Therapy, highlighting data from a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI in people with highly active RMS. February 2026: “Five Years of Ublituximab in Multiple Sclerosis: ULTIMATE I and II Open-Label Extension (OLE) Study”, published in JAMA Neurology, highlighting five-year data from the OLE of the ULTIMATE I and II trials. Pipeline Completed patient enrollment into the ran...

TranscriptFY2026 Q12026-05-06

FY2026 Q1 earnings call transcript

Earnings source - 75 paragraphs
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

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

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

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

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

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

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 milligrams 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

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

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

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

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

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

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

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

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

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

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

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

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

Sean Power

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

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

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

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

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

Sure. Adam, you wanna tackle that one?

Adam Waldman

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

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

Thanks.

Operator

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

Brian Cheng

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

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

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

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

Adam Waldman

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

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

Great. Thank you.

Operator

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

Speaker 12

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

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.

Speaker 12

No. That covers my question. Thank you.

Michael Weiss

Okay. Thank you.

Operator

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

Cha Cha Yang

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

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

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

Great. Thank you.

Operator

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

Michael DiFiore

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 subQ 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

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

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

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

Thank you.

Operator

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

Emily Bodnar

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

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

Adam Waldman

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

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

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

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

Adam Waldman

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

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

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

Jennifer Kim

Great. Thank you.

Operator

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

William Wood

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

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

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

Got it. Thank you.

Michael Weiss

Thank you.

Operator

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

Michael Weiss

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

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.

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook