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    TGTX
    Earnings call· Mar 2026(Q1 FY26)

    TG THERAPEUTICS Q1 FY26 earnings call TGTX

    May 6, 2026 Source

    Executive summary

    TG Therapeutics Q1 FY26 — Record BRIUMVI Revenue and Pipeline Advancement

    TG Therapeutics reported record Q1 FY26 revenue for BRIUMVI, driven by strong new patient enrollments and better-than-expected persistence, leading to a significant raise in full-year guidance. Strategic pipeline advancements for a simplified IV dosing and a subcutaneous formulation are underway, aiming to expand market reach and long-term value. The company also continues to deploy capital through share repurchases and disciplined business development.

    Highlights

    5

    • U.S. BRIUMVI net product revenue reached approximately $195 million in Q1, exceeding guidance of $185 million to $190 million.

    • Total global revenue for BRIUMVI exceeded $200 million for the quarter.

    • Full-year U.S. revenue guidance was raised to $885 million to $900 million.

    • Over 25,000 patients have been prescribed BRIUMVI globally.

    • The company repurchased $100 million of its stock during the quarter at an average price of approximately $30.

    Concerns

    3

    • Competitive environment from established products

    • Impact of BTK class drugs (e.g., remibrutinib) on CD20 class

    • Regulatory approval for pipeline assets

    Guidance & targets

    12
    CategoryTargetConfidence
    U.S. BRIUMVI Net Product Revenue
    $185M-$190M
    high materiality
    High
    Full-year U.S. BRIUMVI Net Revenue
    $885M-$900M
    high materiality
    High
    Q2 U.S. BRIUMVI Net Revenue
    approximately $220M
    medium materiality
    High
    Full-year Total Global Revenue
    approximately $925M
    high materiality
    High
    Full-year Operating Costs (ex-stock-based comp)
    approximately $350M
    medium materiality
    High
    Subcutaneous Manufacturing and Secondary Manufacturer Start-up Activities Costs
    approximately $100M
    medium materiality
    High
    Subcu BRIUMVI Launch
    2028
    high materiality
    Medium
    ENHANCE Study Top-line Data
    coming weeks
    medium materiality
    High
    Subcu BRIUMVI Phase I Bioavailability Data
    coming weeks
    medium materiality
    High
    Subcu BRIUMVI Phase III Top-line Data
    around year-end or early next year
    high materiality
    High
    Myasthenia Gravis Phase II Study Initiation
    this quarter
    low materiality
    High
    Azer-cel Study Updates
    later this year
    low materiality
    Medium

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    BRIUMVI (Global)
    Global revenue includes product sales to Neuroxpharm, the ex-U.S. partner. U.S. revenue exceeded guidance and showed strong year-over-year growth, marking the 12th consecutive quarter of sequential growth since launch. The company is seeing strong persistence and increasing uptake with treatment-naive patients.
    U.S. Net Product Revenue: $195MU.S. Net Product Revenue Growth YoY: 63%Patients Prescribed Globally: >25,000Annualized Run Rate: approaching $1B
    		$201M———

    Operational metrics

    16
    Total Net Product Revenue
    $201M
    Q1 FY26

    Includes U.S. sales and product sales to ex-U.S. partner Neuroxpharm.

    License, Royalty and Other Revenue
    $3.6M
    Q1 FY26

    Additional revenue stream for the quarter.

    Operating Expenses (ex-stock-based comp)
    $117M
    Q1 FY26

    Reflects continued investment across the business, with R&D and SG&A increases.

    Operating Income
    $34.8Mvs $8.6M in Q1 last year
    Q1 FY26

    Driven by revenue growth outpacing expense growth.

    Net Income
    $19.8Mvs $5.1M a year ago
    Q1 FY26

    Includes a one-time $9.2 million charge related to Blue Owl facility refinancing.

    Diluted EPS
    $0.12vs $0.03 a year ago
    Q1 FY26

    Reflects net income for the quarter.

    Cash, Cash Equivalents and Investment Securities
    $573Mup from $200M at year-end
    as of Q1 FY26 end

    Primarily reflects proceeds from the expanded Blue Owl facility.

    Shares Repurchased
    3M+
    Q1 FY26

    Part of the ongoing share repurchase program.

    Total Shares Repurchased (since program launch)
    6.8M
    since program launch

    Represents the cumulative buyback activity.

    Shares Outstanding
    153M
    as of Q1 FY26 end

    After share repurchases.

    Gross-to-Net Discount
    65%
    FY26

    Expected to average out for the full year, Q1 dynamics were in line with expectations.

    New Patient Enrollments
    record
    Q1 FY26

    March was the highest month ever for new patient enrollments.

    Patient Persistence
    stronger than originally modeled
    over time

    Especially as patients move into the second year of treatment, supporting durability.

    Total Monthly Prescribers
    consistent increases
    since November

    March set a new high for prescribers.

    Naive Patient Share
    continues to rise
    Q1 FY26

    Viewed as the strongest leading indicator of long-term market position.

    Subcutaneous Addressable Market
    35%
    current

    Represents a segment the company is not currently participating in, with potential to nearly double the addressable market.

    Industry KPIs

    9
    MetricValueDetails
    Pipeline read out calendarENHANCE Phase III top-line data in coming weeks; Subcu BRIUMVI Phase I bioavailability data in coming weeks; Subcu BRIUMVI Phase III top-line data around year-end or early next year; Azer-cel updates later this year
    Product franchise net sales$195MUSD
    Regulatory approvals filingsPotential 2028 launch for subcu BRIUMVI; Consolidated IV dosing schedule launch next year (assuming approval)
    Peak long term sales guidancemultiples of where we are today
    Therapeutic drug market share#1
    Prescription volume new startsrecord
    Clinical trial efficacy safety dataSustained efficacy and consistent safety/tolerability over 5 years
    Collaboration milestone royalty revenue$3.6MUSD
    Cumulative patients uptake since launch>25,000patients

    Deals & partnerships

    1
    Blue OwlExpanded relationship to enhance financial flexibility

    Refinancing of the Blue Owl facility, resulting in a one-time $9.2 million charge (approximately 50% noncash).

    Risks & headwinds

    3
    Competitive environment from established productsOngoing

    Competitors backed by large organizations

    Mitigation: Delivering on factors that matter most to physicians: compelling clinical profile, operational simplicity, consistent treatment experience (1-hour infusion, twice yearly dosing, long-term data).

    Impact of BTK class drugs (e.g., remibrutinib) on CD20 classFuture, upon potential approvals

    Each BTK in turn has had some difficulties in producing data convincing of clinical benefit over risk.

    Mitigation: Management believes there is a home for BTKs in certain patient populations (e.g., non-active secondary progressive MS) and the oral market, but they will not have a material impact on the CD20 class.

    Regulatory approval for pipeline assetsNext year (ENHANCE), 2028 (subcu BRIUMVI)

    Assumes positive outcome and regulatory approval for ENHANCE and subcu BRIUMVI.

    Mitigation: Ongoing clinical trials and regulatory submissions. Acknowledged 12-month review process for subcu BRIUMVI.

    What to watch in Q2 FY26

    5

    ENHANCE Study Top-line Data

    Q2 FY26
    CurrentExpected in coming weeks
    TargetPositive outcome and regulatory approval for consolidated dosing schedule

    Why it matters

    A positive outcome would simplify BRIUMVI initiation, enhancing operational efficiency and supporting adoption, potentially launching next year.

    I'm pleased to report that based on current time lines, we expect top line data from this Phase III study in the coming weeks.

    Q&A highlights

    8

    What is the market opportunity for the subcutaneous product, and how does 12-week vs 8-week dosing impact share gain potential?

    The subcutaneous segment represents about 35% of the CD20 market, which the company currently doesn't compete in, representing a new patient population. Both 8-week and 12-week dosing would be strong offerings, with 12-week being incrementally better, allowing competition across the entire CD20 landscape.

    “As we mentioned, that segment represents about 35% of the CD20 market today. One, we do not compete in. And our perspective is this is expanding into a new patient population rather than shifting patients within our existing base.”

    asked by Corinne Johnson · answered by Adam Waldman

    2 min read6 chapters

    Detailed Narrative

    01

    BRIUMVI Commercial Momentum and Market Position

    TG Therapeutics reported a record-setting Q1 FY26 for BRIUMVI, with U.S. net product revenue of approximately $195 million, surpassing guidance. Global revenue exceeded $200 million, and the company is on track for a $1 billion annualized run rate before year-end. This growth is attributed to strong new patient enrollments, better-than-expected persistence, and increasing uptake with treatment-naive patients. BRIUMVI has achieved the #1 CD20 dynamic share in private practices with infusion capabilities, driven by its compelling clinical profile and operational simplicity.

    02

    Pipeline Expansion: ENHANCE Study for Simplified IV Dosing

    The Phase III ENHANCE study, evaluating a single 600mg IV infusion for BRIUMVI compared to the current two-infusion schedule, is nearing completion. Top-line data is expected in the coming weeks. A positive outcome and regulatory approval would allow for a consolidated dosing schedule launch next year, enhancing operational efficiency and further supporting adoption by simplifying the initiation process for physicians and patients.

    03

    Strategic Subcutaneous BRIUMVI Program

    The company is developing a self-administered subcutaneous version of BRIUMVI, delivered via an auto-injector or pen-like device. The Phase I bioavailability study results are expected in the coming weeks, and the Phase III program, evaluating every 2-month and quarterly dosing, is fully enrolled with top-line data expected around year-end or early next year. This program aims to nearly double the addressable market by competing in the 35% of the anti-CD20 market currently served by self-administered options, with a potential launch in 2028.

    04

    Expansion into New Autoimmune Indications

    Beyond relapsing MS, TG Therapeutics is expanding BRIUMVI's reach into additional autoimmune indications. Phase I work for Myasthenia Gravis is complete, with a Phase II potentially registration-directed study expected to initiate this quarter. An exploratory study in treatment-resistant schizophrenia is also being initiated, based on emerging evidence of an autoimmune component in a subset of these patients, representing a significant potential opportunity if validated.

    05

    Azer-cel Advancement in Progressive MS

    The allogeneic anti-CD19 CAR-T program, azer-cel, continues to advance in progressive MS. Trial sites are identifying more patients than available slots, highlighting the unmet medical need. The company is progressing through dose escalation and expects to share updates later this year, with safety being the primary focus, followed by biomarkers of activity.

    06

    Capital Allocation Strategy and Share Repurchases

    The company expanded its relationship with Blue Owl, enhancing financial flexibility. This enables continued share repurchases, with $100 million of stock bought back in Q1 at an average price of approximately $30. Since launching the program, 6.8 million shares have been repurchased. The company maintains a disciplined approach to capital allocation, balancing internal investments, share buybacks, and selective business development opportunities.

    AI-generated summary of the company’s earnings call. Not investment advice.