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TG THERAPEUTICS, INC. (TGTX)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 delivered strong top-line growth: total revenue $120.9M, with BRIUMVI U.S. net revenue of $119.7M (+137% YoY), and management raised FY2025 revenue guidance; however GAAP EPS of $0.03 missed S&P Global consensus of $0.17 as operating investments increased .*
- Revenue beat consensus by ~$3.0M (+2.5%); EBITDA was ~$8.6M versus ~$32.0M consensus; EPS missed by $0.14, reflecting higher R&D tied to subcutaneous BRIUMVI manufacturing and pipeline advancement .*
- Guidance raised: FY2025 BRIUMVI U.S. net revenue to ~$560M (from $525M) and total global revenue to ~$575M (from $540M); Q2 2025 BRIUMVI U.S. net product revenue targeted at $135M .
- Commercial momentum: record new enrollments, repeat prescribers at all-time highs, and hospital enrollments reached ~60% of March volume; management announced the first direct-to-patient TV campaign to further accelerate uptake .
- Strategic catalysts: pivotal programs for simplified IV dosing (single 600 mg Day 1) and subcutaneous BRIUMVI targeted to begin in 2025; CFO flagged minimal expected gross margin impact from proposed tariffs given low COGS .
Values retrieved from S&P Global.*
What Went Well and What Went Wrong
What Went Well
- BRIUMVI U.S. net revenue was $119.7M (+137% YoY; +16% QoQ), demonstrating accelerating adoption and persistence trends; repeat prescriptions surpassed new, and hospital enrollments accounted for ~60% of March enrollments .
- Guidance raised on strength of leading indicators: FY2025 BRIUMVI U.S. net revenue ~$560M and global ~$575M; Q2 2025 targeted $135M .
- CEO emphasized confidence and differentiation: “Our performance… including BRIUMVI’s $119.7 million in U.S. net sales, demonstrates the growing confidence… and increasing adoption,” reiterating the long-term goal for BRIUMVI “becoming the number one prescribed anti-CD20… based on dynamic market share” .
What Went Wrong
- EPS and EBITDA missed consensus: GAAP diluted EPS $0.03 vs $0.17 and EBITDA ~$8.6M vs ~$32.0M, as operating expenses tracked slightly ahead of run-rate due to subcutaneous manufacturing investments (about $20M in the quarter) .*
- License/other revenue fell to ~$1.2M vs ~$13.0M in the prior year, lapping the $12.5M EU milestone from Q1 2024, creating a tougher multi-period compare .
- Interest expense increased to ~$6.8M and total other expense to ~$3.2M, modestly dampening net income growth despite strong operating performance .
Values retrieved from S&P Global.*
Financial Results
P&L and Earnings vs Prior Periods
Revenue Composition
Operating Expense Detail
Actual vs S&P Global Consensus (Q1 2025)
Values retrieved from S&P Global.*
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- CEO: “2025 is off to a strong start… BRIUMVI’s $119.7 million in U.S. net sales… reinforces our belief that we can achieve our long-term goal of BRIUMVI becoming the number one prescribed anti-CD20 treatment…” .
- CEO on simplified regimen: “Starting all patients on Briumvi with a single 600-milligram dose on day 1… making Briumvi a true twice-a-year therapy from day 1. We are now preparing to advance this regimen into its registration-directed trial.” .
- CCO: “We are raising our full year 2025 U.S. net revenue guidance… to $560 million… [and] currently targeting $135 million for the second quarter.” .
- CFO: “Excluding noncash items, our total OpEx… came in at approximately $82 million… driven by about $20 million in manufacturing investments for subcutaneous Briumvi… we remain confident in our full year OpEx guidance of approximately $300 million.” .
- CFO on tariffs: “Given our relatively low cost of goods, we do not anticipate that the currently proposed tariffs will have a material impact on our gross margins or overall financial performance.” .
Q&A Highlights
- Competitive dynamics: Management reported “0 impact” from OCREVUS de novo on BRIUMVI; market share gains continue, with repeat prescribers at highs .
- Gross-to-net and margins: No material change in gross-to-net; Part D redesign not relevant (drug billed like Part B). Pre-commercial inventory reserve fully depleted; margins going forward reflect “fully baked” levels .
- Subcutaneous dosing regimens: Leaning toward two pivotal regimens (every other month and quarterly); PK data expected later in 2025 .
- 30-minute infusion feedback: Physicians and patients view it favorably for convenience; data suggests good tolerability .
- Manufacturing outlook: NC facility remains multi-year; designed for redundancy rather than tariff avoidance; minimal expected tariff impact per CFO .
Estimates Context
- Q1 2025: Revenue of $120.9M vs consensus $117.9M – a modest beat; GAAP EPS $0.03 vs $0.17 – significant miss; EBITDA ~$8.6M vs ~$32.0M – significant miss. Management raised FY guidance despite the EPS shortfall, citing strong demand, persistence, and leading indicators .*
- Forward consensus implies continued growth: Q3 2025 revenue ~$152.0M, EPS ~$0.22; Q4 2025 revenue ~$182.4M, EPS ~$0.25; Q1 2026 ~$197.7M, EPS ~$0.34; Q2 2026 ~$215.8M, EPS ~$0.41 [GetEstimates].*
Values retrieved from S&P Global.*
Forward S&P Global Consensus
Values retrieved from S&P Global.*
Key Takeaways for Investors
- Top-line momentum is intact and accelerating; BRIUMVI U.S. net revenue rose to $119.7M (+16% QoQ; +137% YoY), and FY guidance was raised – a constructive signal for trajectory and market share gains .
- EPS and EBITDA misses reflect front-loaded investments (subcutaneous manufacturing and pivotal preparations), not demand weakness; near-term earnings leverage may be deferred as TG prioritizes life-cycle innovation .
- Commercial execution is broadening: record enrollments, hospital penetration (~60% of March enrollments), and the first DTC TV campaign should support further patient activation and prescriber confidence .
- Pipeline catalysts in 2025: pivotal trials for simplified IV regimen (single 600 mg Day 1) and subcutaneous dosing (EOM/quarterly) are potential differentiation drivers versus incumbents .
- Tariff concerns likely a limited risk: BRIUMVI’s low COGS and diversified manufacturing roadmap (FUJIFILM in NC as secondary) underpin margin resilience per CFO .
- Estimate revisions: Expect sell-side to raise revenue estimates on stronger Q2 target and FY guide, but trim near-term EPS/EBITDA on higher OpEx; watch for Q2 execution vs $135M target as the next inflection point .*
- Trading implications: Near term, the raised FY guide is a positive catalyst; monitor persistence metrics and hospital adoption data points, as these drive narrative on durability. Medium term, pivotal read-throughs on simplified dosing and subcutaneous could re-rate the life-cycle optionality .
Values retrieved from S&P Global.*
KPIs
Segment Breakdown (Revenue)
Management Commentary (Prepared Remarks)
- “We believe patients will appreciate the simplicity of starting treatment with just 1 infusion visit, making Briumvi a true twice-a-year therapy from day 1.” – Michael Weiss, CEO .
- “Subcu injection appears to be well tolerated… bioavailability… supports every other month or even potentially quarterly dosing… on track to launch a pivotal trial this year.” – Michael Weiss, CEO .
- “We will be launching our first ever direct-to-patient Briumvi television commercial campaign… to educate, inspire and activate eligible patients.” – Adam Waldman, CCO .
- “We reported GAAP net income of approximately $5 million… we closed the quarter with $276 million… puts us in a strong financial position… and we remain confident in our full year OpEx guidance of approximately $300 million.” – Sean Power, CFO .
Estimates and Results Comparison (Detail)
Values retrieved from S&P Global.*
Clear Implications
- The guidance raise and strong demand indicators are bullish; near-term stock narrative likely hinges on Q2 delivery versus the $135M target and evidence of sustained persistence and hospital penetration .
- EPS sensitivity remains tied to R&D and SG&A cadence as life-cycle programs advance; watch R&D timing linked to pivotal starts and subcutaneous CMC loads for quarterly variability .
- Pivotal programs for simplified IV dosing and subcutaneous BRIUMVI constitute medium-term catalysts that could enhance BRIUMVI’s convenience differentiation and expand addressable patient segments .