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TT

TG THERAPEUTICS, INC. (TGTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 delivered record revenue and profitability: product revenue, net rose to $107.3M (U.S. BRIUMVI $103.6M), total revenue $108.2M, GAAP diluted EPS $0.15, and net income $23.3M, driven by continued U.S. BRIUMVI adoption and initial ex-U.S. shipments to partner Neuraxpharm .
  • Management introduced 2025 guidance targeting ~$540M total global revenue (U.S. BRIUMVI ~$525M) and OpEx of ~$300M (ex‑non‑cash), and guided Q1 2025 U.S. BRIUMVI net revenue of ~$115M, underscoring confidence in growth trajectory .
  • Sequential operating momentum continued (Q2→Q3→Q4 product revenue: $72.6M → $83.3M → $107.3M); gross margin optics in Q4 were modestly impacted by lower‑margin partner shipments embedded in COGS, but underlying U.S. margin consistency was reiterated .
  • Strategic milestones de‑risk the outlook: three U.S. patents extend BRIUMVI protection through 2042; subcutaneous (SC) formulation and IV administration enhancements (30‑minute maintenance infusion; consolidated day‑1 dosing) advance toward pivotal programs; EU/UK launch progressed via Neuraxpharm .

What Went Well and What Went Wrong

What Went Well

  • Robust commercial execution: U.S. BRIUMVI net sales reached $103.6M in Q4 (24% QoQ), driving total product revenue, net to $107.3M and GAAP diluted EPS to $0.15 .
  • Positive early 2025 read‑through and raised bar: management called out record Jan/Feb enrollments in the hub and guided ~$115M U.S. BRIUMVI net revenue for Q1 2025; full‑year 2025 targets set at $540M global/$525M U.S. .
  • Strategic and clinical differentiation: five‑year ULTIMATE data show 92% free of disability progression and ARR 0.02 in year 5; ENHANCE shows feasibility of 30‑minute maintenance infusion and direct switching from other anti‑CD20s without the 150 mg load (97% infusions completed without slowing); CEO: “2024 was a year of significant outperformance and growth… strong adoption of BRIUMVI… strengthening our BRIUMVI patent portfolio through 2042” .

What Went Wrong

  • Gross margin optics in Q4: CFO noted cost of goods included lower‑margin ex‑U.S. partner shipments (~$3.7M revenue), creating the appearance of an unfavorable gross margin impact in the quarter vs U.S. commercial sales; underlying gross margin otherwise consistent .
  • Elevated interest expense YoY: interest expense was $7.1M in Q4 2024 vs $2.4M in Q4 2023 following the $250M credit facility, though partly offset by higher operating income .
  • Consensus estimates: S&P Global consensus for Q4 and near‑term periods was unavailable at time of analysis due to SPGI request limits, limiting beat/miss benchmarking (see Estimates Context).

Financial Results

Sequential quarterly P&L and cash metrics

MetricQ2 2024Q3 2024Q4 2024
Product revenue, net ($USD Millions)$72.596 $83.297 $107.347
Total revenue ($USD Millions)$73.466 $83.879 $108.185
Cost of revenue ($USD Millions)$8.304 $9.341 $15.399
Gross margin % (calc)88.7% (calc from )88.9% (calc from )85.8% (calc from )
Operating income ($USD Millions)$8.816 $12.434 $29.949
Net income ($USD Millions)$6.879 $3.880 $23.330
Diluted EPS ($)$0.04 $0.02 $0.15
Cash, cash equivalents & investments ($USD Millions)$217.252 $341.041 $311.001

Q4 2024 versus prior year (Q4 2023)

MetricQ4 2023Q4 2024
Product revenue, net ($USD Millions)$43.137 $107.347
License/milestone/royalty & other revenue ($USD Millions)$0.834 $0.838
Total revenue ($USD Millions)$43.971 $108.185
Cost of revenue ($USD Millions)$7.855 $15.399
Operating income ($USD Millions)$(12.485) $29.949
Net income ($USD Millions)$(14.416) $23.330
Diluted EPS ($)$(0.10) $0.15

Revenue composition detail

Revenue ComponentQ2 2024Q3 2024Q4 2024
U.S. BRIUMVI net sales ($USD Millions)$72.6 $83.3 $103.6
Product sold to partner (ex‑U.S.) ($USD Millions)N/A disclosedN/A disclosed~$3.7
License/milestone/royalty & other revenue ($USD Millions)$0.870 $0.582 $0.838

KPI highlights

  • Gross‑to‑net expected at 70–75% with quarterly variability .
  • Dynamic market share: “about 1 in 4” patients on IV anti‑CD20 (segment ~60% of RMS), with trend increasing .
  • Hospital setting now majority of growth/enrollments; Jan/Feb were highest hub enrollments since launch .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total global revenueFY 2025N/A~ $540M target New
U.S. BRIUMVI net revenueFY 2025N/A~ $525M target New
Operating expenses (ex‑non‑cash)FY 2025N/A~ $300M target New
U.S. BRIUMVI net revenueQ1 2025N/A~ $115M (company expectation) New
U.S. BRIUMVI net revenueFY 2024$300–$305M (as of Q3) Actual $310M U.S. Outperformed prior target

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
BRIUMVI U.S. adoption and shareQ2: VA formulary preferred; $72.6M U.S. net; raising FY24 guidance . Q3: $83.3M; dynamic share ~15% of CD20; hospitals 55% of business .Q4: $103.6M U.S.; “1 in 4” IV CD20 starts; hospitals majority of enrollments .Accelerating
Infusion experience (30‑min infusion; consolidated day‑1 dose)Q3 ENHANCE data introduced (30‑min maintenance; switch without 150 mg) .Reinforced; randomized safety studies planned; potential sBLA timeline mid‑2027 for consolidated day‑1 .Advancing
Subcutaneous BRIUMVIQ2: Phase 1 in RMS initiated . Q3: targeting pivotal mid‑2025; every‑other‑month dosing goal .Pivotal targeted mid‑2025; dosing interval Q2M or Q3M under consideration .Advancing
Manufacturing/supply chainQ3: FUJIFILM Diosynth secured as secondary U.S. manufacturer .No near‑term GM impact; upfront costs flow through R&D .De‑risking supply
Payor/access & GTNQ3: 95% coverage; patient awareness investment ramp .Gross‑to‑net 70–75% expected; robust Q1 demand .Stable
Pipeline (azer‑cel)Q2: IND cleared for progressive MS . Q3: Phase 1 to launch late ’24/early ’25 .Phase 1 ready to enroll; dose‑finding focus .Early stage
IP/RegulatoryPatents through 2042 discussed in Q2/Q3 .Patents through 2042 reiterated .Strengthened

Management Commentary

  • CEO on 2024 performance and differentiation: “2024 was a year of significant outperformance and growth… strong adoption of BRIUMVI… strengthening our BRIUMVI patent portfolio through 2042” .
  • Clinical durability: “after 5 years of BRIUMVI treatment, 92% of patients were free from disability progression… annualized relapse rate of 0.02 in year 5” .
  • Commercial momentum and 2025 setup: “January and February [2025] being our highest month of total new patients into our hub since launch… estimating $115 million in U.S. BRIUMVI net revenue in Q1” .
  • SC path: “target is to get this going… by middle of the year… whether it’s going to be every 2 months or every 3 months… yet to be determined” .
  • Label enhancement path: “We hope to have a … PDUFA date for [consolidated day‑1] by mid ’27” .

Q&A Highlights

  • Q1 and FY25 outlook: Robust early 2025 demand; Q1 U.S. BRIUMVI net revenue guided to ~$115M; confident in meeting/exceeding FY25 ~$525M U.S. target .
  • Gross‑to‑net: Expect 70%–75% with quarterly fluctuations .
  • Subcutaneous program: Pivotal targeted mid‑2025; regimen could be every 2 or 3 months; study size ~125–150 per arm; ~12‑month enrollment .
  • IV administration enhancements: Randomized safety studies planned for 30‑minute infusion; consolidated day‑1 dosing could move fastest; potential mid‑2027 PDUFA .
  • Share trends: Dynamic share “about 1 in 4” IV CD20 starts; hospital setting accounts for most growth .
  • Manufacturing redundancy: FUJIFILM secondary site won’t impact near‑term gross margin; upfront costs in R&D .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 revenue/EPS and near‑term periods was unavailable due to SPGI daily request limits at time of retrieval. As a result, explicit beat/miss versus consensus cannot be stated here. Management did exceed its own FY24 U.S. BRIUMVI target ($310M actual vs $300–$305M prior guide) and introduced FY25 targets ($540M global/$525M U.S.), along with a Q1 2025 U.S. outlook of ~$115M .

Key Takeaways for Investors

  • Commercial engine is scaling: sequential product revenue acceleration ($72.6M → $83.3M → $107.3M) and positive EPS ($0.15) signal operating leverage as BRIUMVI penetration deepens, especially in hospitals .
  • 2025 guide and Q1 preview frame upside: $540M total/$525M U.S. targets and ~$115M Q1 U.S. point to sustained momentum; watch realization vs seasonality and access dynamics .
  • Differentiated profile continues to firm: long‑term efficacy/safety and ENHANCE updates (30‑minute infusion; direct switches) support share gains; pivotal programs could catalyze label evolution by mid‑2027 .
  • Margin watch‑items: Partner shipments can temporarily dilute reported gross margin mix; underlying U.S. gross margin described as consistent—track mix and ex‑U.S. ramp .
  • Investment phase in 2025: OpEx stepping to ~$300M (ex‑non‑cash) to fund SC pivotal, IV enhancements, commercialization, and azer‑cel initiation—balanced by profitability and $311M cash .
  • Competitive lens: Early commentary suggests limited impact from new entrants to date; dynamic share improving; gross‑to‑net 70–75% is a key assumption to monitor .
  • Pipeline optionality: SC BRIUMVI, IV administration improvements, and azer‑cel in autoimmune diseases provide medium‑term catalysts beyond core RMS .

Sources

  • Q4 2024 8‑K/Press Release:
  • Q4 2024 Earnings Call Transcript:
  • Companion Press Release (Mar 3, 2025):
  • Q3 2024 8‑K and Call:
  • Q2 2024 8‑K: