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    TGTX
    Earnings call· Dec 2025(Q4 FY25)

    TG THERAPEUTICS Q4 FY25 earnings call TGTX

    Feb 26, 2026 Source

    Executive summary

    TG Therapeutics Q4 FY25 — BRIUMVI Drives Strong Growth, Pipeline Advances

    TG Therapeutics delivered a strong Q4 and full-year 2025, driven by robust BRIUMVI sales and market share gains in the relapsing multiple sclerosis (RMS) market. The company is advancing its pipeline with ENHANCE and subcutaneous BRIUMVI programs, aiming to simplify treatment and expand market opportunity. Management reaffirmed its full-year 2026 revenue guidance, balancing strong demand with typical Q1 seasonal headwinds, and emphasized a flexible capital allocation strategy focused on maximizing BRIUMVI, judicious pipeline expansion, and share repurchases.

    Highlights

    5

    • Total global revenue reached approximately $616 million for FY25.

    • BRIUMVI U.S. net sales were $594 million for FY25, with Q4 sales of $183 million.

    • Q4 FY25 U.S. net sales grew approximately 92% year-over-year and 20% sequentially.

    • 6-year open-label extension data for BRIUMVI showed nearly 90% of patients free from 24-week confirmed disability progression.

    • The company expects to continue generating positive cash flow in 2026 and beyond.

    Concerns

    2

    • Q1 FY26 U.S. revenue is expected to be $185 million to $190 million, reflecting typical seasonal headwinds like benefit reverifications and gross-to-net variability due to deductible resets.

    • Gross margin for Q4 FY25 was slightly below typical due to timing of sales to an ex-U.S. partner and a one-time inventory reserve.

    Guidance & targets

    7
    CategoryTargetConfidence
    Positive cash flow
    Continue generating positive cash flow
    high materiality
    High
    Full year U.S. BRIUMVI net revenue
    $825 million to $850 million
    high materiality
    High
    Total global revenue
    $875 million to $900 million
    high materiality
    High
    U.S. revenue
    $185 million to $190 million
    medium materiality
    High
    Ex-U.S. revenue
    $5 million to $10 million
    medium materiality
    High
    Full year operating expenses (excluding noncash comp)
    approximately $350 million
    medium materiality
    High
    Subcutaneous BRIUMVI manufacturing and secondary manufacturer start-up expenses
    approximately $100 million
    medium materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    U.S. BRIUMVI
    Strong performance in the fourth quarter, showing significant year-over-year and sequential growth, contributing the vast majority of global revenue.
    Full year 2025 net revenue: $594 million
    		$183 million92%20%—
    Ex-U.S. (Neuraxpharm)
    Revenue from sales to partner Neuraxpharm for ex-U.S. commercialization.
    Full year 2025 revenue from products supplied to Neuraxpharm: $12.8 million
    		$6.4 million———
    Global Total
    Total net product revenue for the quarter, including U.S. and ex-U.S. sales.
    Full year 2025 global revenue: $616 million
    		$189.1 million———

    Operational metrics

    13
    Operating income
    $123 million
    FY25

    Operating income for the full year, resulting from revenue growth significantly exceeding operating expense increase.

    Net income
    $23 million
    Q4 FY25

    Net income for the fourth quarter.

    Net income
    $447.2 millionvs $23.4 million in 2024
    FY25

    Full year net income, including a nonrecurring income tax benefit of approximately $340 million.

    Diluted EPS
    $0.14
    Q4 FY25

    Diluted earnings per share for the fourth quarter.

    Diluted EPS
    $2.77vs $0.15 in 2024
    FY25

    Diluted earnings per share for the full year, including a nonrecurring income tax benefit.

    Nonrecurring income tax benefit
    approximately $340 million
    Q3 FY25

    Primarily related to the release of deferred tax asset valuation allowance.

    Cash, cash equivalents and investment securities
    approximately $200 million
    Year-end 2025

    Balance of liquid assets at the end of the fiscal year.

    Accounts receivable
    $300 million
    Year-end 2025

    Balance of accounts receivable at the end of the fiscal year.

    Inventory
    $140 million
    Year-end 2025

    Balance of inventory at the end of the fiscal year.

    Share repurchase program completed
    $100 million
    FY25

    Completion of a previously authorized share repurchase program.

    Additional share repurchase authorization
    $100 million
    FY25

    Board authorized an additional share repurchase program, reflecting confidence in long-term outlook.

    Operating expenses (excluding noncash comp)
    approximately $328 millionin line with prior guidance of $300 million to $320 million
    FY25

    Full year operating expenses, slightly above guidance due to incremental manufacturing and development costs for subcu BRIUMVI and commercial investment.

    Subcu market share
    35% to 40%relatively stable
    Current

    The subcu portion of the anti-CD20 market has been relatively stable, but is expected to expand with new options.

    Industry KPIs

    7
    MetricValueDetails
    Pipeline read out calendarENHANCE study top-line data midyear 2026; Subcutaneous BRIUMVI pivotal top-line data later 2026 or early 2027; Azer-cel updates later 2026
    Product franchise net sales$594 millionUSD
    Therapeutic drug market shareDynamic share gains
    Prescription volume new startsStrongest level since launch
    Clinical trial efficacy safety dataNearly 90% free from 24-week confirmed disability progression%
    Collaboration milestone royalty revenue$9.4 millionUSD
    Cumulative patients uptake since launchVery strong

    Deals & partnerships

    2
    NeuraxpharmEx-U.S. commercialization of BRIUMVI

    Partner for commercialization of BRIUMVI outside the U.S. Expected to opt into the subcutaneous program when offered.

    Christina ApplegateLaunch of NextInMS.com educational platform

    Partnership to launch an educational platform for individuals living with RMS and their caregivers, focusing on education, empowerment, and informed dialogue.

    Risks & headwinds

    2
    Seasonal headwinds impacting Q1 revenueQ1 FY26

    Q1 FY26 U.S. revenue expected to be $185 million to $190 million, reflecting typical seasonal headwinds.

    Mitigation: These dynamics are consistent with historical trends and fully incorporated into full-year guidance.

    Gross margin impact from ex-U.S. sales timing and inventory reserveQ4 FY25

    Gross margin for Q4 FY25 was slightly below typical.

    Mitigation: Caused by timing of sales to ex-U.S. partner and a one-time inventory reserve, implying it is not a structural issue.

    What to watch in Q1 FY26

    5

    ENHANCE trial top-line data

    Midyear 2026
    CurrentEnrollment complete
    TargetTop-line data release

    Why it matters

    Successful data could simplify BRIUMVI treatment, potentially increasing market share and convenience for patients and centers.

    Enrollment is complete. We expect top line data midyear with the potential 2027 launch of this consolidated treatment schedule.

    Q&A highlights

    6

    How do dynamics of accelerating subcu uptake by competitors in community practices fit with BRIUMVI's broad momentum across academic and community settings in the HCP administered segment? Where is the strongest incremental momentum?

    BRIUMVI continues to gain share in the IV segment, with de novo business primarily from Ocrevus IV. Growth is seen across both private practice and academic centers, driven by clinical data, 6-year safety data, and operational advantages. New patient enrollments are at their highest since launch, and persistence is strong.

    “It seems like the majority of the de novo business seems to be coming from Ocrevus IV. But importantly, we're also -- we're not seeing any decreases in the switches from Ocrevus to BRIUMVI.”

    asked by Michael DiFiore · answered by Adam Waldman

    2 min read5 chapters

    Detailed Narrative

    01

    BRIUMVI Performance and Market Position

    BRIUMVI achieved approximately $616 million in total global revenue for FY25, with U.S. net sales of $594 million. Q4 FY25 U.S. net sales were $183 million, marking 92% year-over-year and 20% sequential growth. The drug continues to gain dynamic share in the IV anti-CD20 segment, driven by its clinical profile, 6-year safety data, and operational advantages like a 1-hour twice-yearly maintenance infusion. Growth is broad-based across academic and community settings, with record new patient enrollments and strong persistence on therapy.

    02

    Pipeline Advancement: ENHANCE and Subcutaneous BRIUMVI

    The Phase III ENHANCE study, evaluating a single 600mg dose of BRIUMVI (consolidating day 1 and day 15 infusions), has completed enrollment with top-line data expected midyear 2026 and a potential 2027 launch. The subcutaneous BRIUMVI program, a self-administered at-home auto-injector, is approximately 75% enrolled in its Phase III study, with pivotal top-line data targeted for late 2026 or early 2027 and a potential 2028 launch. This subcu formulation is expected to significantly expand the total addressable market.

    03

    Capital Allocation Strategy

    TG Therapeutics expects to generate positive cash flow in 2026 and beyond, providing financial flexibility. Capital priorities include maximizing the BRIUMVI opportunity, judiciously expanding the pipeline, and repurchasing shares when undervalued. The company completed a $100 million share repurchase program and authorized an additional $100 million, viewing shares as significantly undervalued relative to expected cash flow.

    04

    Commercial Strategy and Field Expansion

    The company expanded its field organization in 2025 to deepen coverage in high-opportunity geographies and broaden reach among community neurologists and independent infusion centers. This expanded footprint is driving increased prescriber engagement and is expected to accelerate penetration in 2026. Direct-to-patient engagement efforts also expanded, including a partnership with Christina Applegate for the Next In MS educational platform, which has exceeded engagement expectations.

    05

    Q1 FY26 Outlook and Gross-to-Net Dynamics

    For Q1 FY26, U.S. revenue is projected to be $185 million to $190 million, showing sequential growth over Q4 despite typical seasonal headwinds. These headwinds include benefit reverifications and gross-to-net variability driven by deductible resets, which are consistent with historical trends in the specialty product category and fully incorporated into the full-year guidance. Ex-U.S. revenue for Q1 is expected to be $5 million to $10 million.

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