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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

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$83.9 $108.2 $120.9
Product Revenue, Net ($USD Millions)$83.3 $107.3 $119.7
License/Milestone/Other Revenue ($USD Millions)$0.6 $0.8 $1.2
Cost of Revenue ($USD Millions)$9.3 $15.4 $15.5
Gross Margin (%)88.9% 85.8% 87.1%
Operating Income ($USD Millions)$12.4 $29.9 $8.6
Net Income ($USD Millions)$3.9 $23.3 $5.1
Diluted EPS ($USD)$0.02 $0.15 $0.03
Cash & Equivalents ($USD Millions)$341.0 $311.0 $276.2

Revenue Composition

MetricQ3 2024Q4 2024Q1 2025
BRIUMVI U.S. Net Revenue ($USD Millions)$83.3 $103.6 $119.7
Ex-U.S. Product Sales to Partner ($USD Millions)~$3.7 (Q4 only) ~$3.7
License/Milestone/Other ($USD Millions)$0.6 $0.8 $1.2

Operating Expense Detail

Metric ($USD Millions)Q3 2024Q4 2024Q1 2025
R&D Total$20.1 $23.9 $46.4
SG&A Total$42.0 $39.0 $50.3
OpEx (R&D + SG&A)$62.1 $62.9 $96.7

Actual vs S&P Global Consensus (Q1 2025)

MetricQ1 2025
Revenue Actual ($USD Millions)$120.9
Revenue Consensus ($USD Millions)$117.9*
EPS Actual (GAAP, $USD)$0.03
EPS Consensus (GAAP, $USD)$0.17*
EBITDA Actual ($USD Millions)$8.6*
EBITDA Consensus ($USD Millions)$32.0*

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BRIUMVI U.S. Net Revenue ($USD Millions)FY 2025~$525 ~$560 Raised
Total Global Revenue ($USD Millions)FY 2025~$540 ~$575 Raised
BRIUMVI U.S. Net Revenue ($USD Millions)Q2 2025$135 New/Target
Operating Expense (excl. non-cash; $USD Millions)FY 2025~ $300 ~ $300 Maintained

Earnings Call Themes & Trends

TopicQ3 2024 (Previous Mentions)Q4 2024 (Previous Mentions)Q1 2025 (Current)Trend
BRIUMVI adoption & market shareU.S. net revenue $83.3M; IV anti-CD20 share expansion; 5-year data reinforces profile U.S. net revenue $103.6M; patent portfolio extended to 2042 U.S. net revenue $119.7M; record enrollments; repeat Rx > new; hospital enrollments ~60% in March Strengthening adoption
Simplified IV regimen (600 mg Day 1) & 30-min infusionENHANCE data supports 30-min infusion; switching directly to 450 mg for B-cell depleted Continued emphasis on enhancing patient experience Preparing registration-directed trial for 600 mg Day 1; positive feedback on 30-min infusion Advancing to pivotal
Subcutaneous BRIUMVIInitiated Phase 1 in RMS Launched Phase 1; MG Phase 1 enrolling Phase 1 showing promising tolerability; bioavailability supports every-other-month or quarterly dosing; pivotal planned 2025 Moving to pivotal
Competitive dynamics vs OCREVUSN/AN/AManagement “seen 0 impact” from OCREVUS de novo on BRIUMVI Neutral
Tariffs/macro & manufacturingN/ASecured FUJIFILM Diosynth as secondary U.S. manufacturer (Holly Springs, NC) CFO expects minimal margin impact from proposed tariffs; NC facility commercialization several years out Monitoring; low risk near-term
DTC & commercializationN/AN/AFirst direct-to-patient TV campaign; digital surround strategy New growth lever
Regulatory/LegalN/APatents extended through 2042 Continued ex-U.S. commercialization via partner Portfolio strengthening

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

MetricQ3 2025Q4 2025Q1 2026Q2 2026
Revenue Consensus ($USD Millions)152.0*182.4*197.7*215.8*
EPS Consensus (GAAP, $USD)0.22*0.25*0.34*0.41*
EBITDA Consensus ($USD Millions)38.4*65.4*56.6*71.8*
# of EPS Estimates7*7*6*6*
# of Revenue Estimates8*8*5*6*

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

KPIQ3 2024Q4 2024Q1 2025
BRIUMVI U.S. Net Revenue ($USD Millions)$83.3 $103.6 $119.7
Sequential Growth (QoQ)+24.3% +16%
YoY Growth (BRIUMVI U.S.)+230% +250% (FY) +137%
Hospital Enrollments (% of March enrollments)~60%
Repeat Prescriptions Surpassed NewYes

Segment Breakdown (Revenue)

SegmentQ3 2024Q4 2024Q1 2025
Product Revenue, Net ($USD Millions)$83.3 $107.3 $119.7
License/Milestone/Other ($USD Millions)$0.6 $0.8 $1.2

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)

MetricQ1 2025
Revenue: Actual vs Consensus ($USD Millions)$120.9 vs $117.9; beat by ~$3.0M (+2.5%) .*
EPS (GAAP): Actual vs Consensus ($USD)$0.03 vs $0.17; miss by $0.14 .*
EBITDA: Actual vs Consensus ($USD Millions)~$8.6 vs ~$32.0; miss by ~$23.4M.*

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 .