TG THERAPEUTICS, INC. (TGTX)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 total revenue was $141.1M, with BRIUMVI U.S. net product revenue of $138.8M, up 91% year over year and 16% sequentially .
• Management raised FY25 BRIUMVI U.S. net revenue guidance to $570–$575M and total global revenue to ~$585M; OpEx guidance remains ~$300M (excl. non-cash comp) .
• Versus S&P Global consensus, the company missed on revenue ($141.1M vs $146.3M) and EPS ($0.17 vs $0.28), with management citing summer seasonality and hospital-mix-driven gross-to-net effects as headwinds; guidance was raised despite these dynamics .
• Call commentary highlighted momentum in adoption (about one-third of new IV anti-CD20 starts choosing BRIUMVI), initiation of pivotal programs (ENHANCE day-1 consolidation, subcutaneous), and the first autoimmunity CAR-T dosing, all supportive near- and medium-term catalysts .

What Went Well and What Went Wrong

What Went Well

• “We’re incredibly proud of the continued momentum behind BRIUMVI… gives us confidence in reaching our updated 2025 full year BRIUMVI U.S. net revenue guidance of $570 to $575 million” — Michael Weiss (CEO) .
• Highest number of new patient enrollments into the hub since launch; increased new prescribers and new accounts across academic and community settings .
• Initiated randomized Phase 3 ENHANCE cohort to consolidate day-1 and day-15 IV dosing; first patient dosed with azer‑cel in progressive MS; subcutaneous BRIUMVI pivotal trial preparation tracking to plan .

What Went Wrong

• Revenue and EPS missed S&P Global consensus; revenue shortfall tied to summer seasonality and hospital channel mix pulling gross-to-net toward the lower end of range .
• OpEx rose year over year as R&D and SG&A investments ramped for subcutaneous development and commercialization (R&D $31.8M; SG&A $55.6M in Q2) .
• License/milestone revenue was modest ($2.3M Q2), highlighting reliance on U.S. BRIUMVI product revenue for near-term growth .

Financial Results

Income Statement and Margins (YoY and Seq. Comparison)

Segment / Revenue Composition

KPIs and Operating Drivers

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We believe BRIUMVI is well positioned to lead the class and redefine treatment expectations for people living with MS.” — Michael Weiss (CEO) .
• “U.S. net sales for BRIUMVI in Q2 totaled approximately $139 million… highest volume of new patient enrollments to date… physicians are reporting more patients requesting BRIUMVI by name.” — Adam Waldman (CCO) .
• “GAAP net income of $28.2 million or $0.17 per diluted share… We continue to expect full year operating expenses to be ~ $300 million.” — Sean Power (CFO) .
• “We have begun enrollment into a randomized, double blind Phase III cohort evaluating [consolidation to] a single six hundred milligram infusion on day one.” — Michael Weiss (CEO) .

Q&A Highlights

• Seasonality and cadence: Guidance reflects summer seasonality; expect stronger Q3→Q4 growth than Q2→Q3 .
• Market structure and payer dynamics: Roughly 60–65% of anti‑CD20 dynamic market is IV; subcu around 35–40%; company building subcu option; limited payer push yet but preparing for potential shift .
• Subcu device strategy: Main study uses vial/syringe for bioequivalence, with bridging to established auto‑injector; aiming for BLA filing in 2027 and potential launch in 2028 .
• Persistence/adherence: Week‑24 and preliminary week‑48 persistence above expectations vs published CD20 benchmarks .
• Gross‑to‑net and mix: FY gross‑to‑net 70–75%; Q2 closer to ~70% driven by growth in hospital segment and mandated discounts (e.g., 340B) .

Estimates Context

Values retrieved from S&P Global.
Interpretation: Both top- and bottom-line missed consensus. Drivers include seasonal demand patterns and gross-to-net headwinds from hospital channel mix; management nonetheless raised FY revenue guidance, suggesting confidence in H2 trajectory .

Key Takeaways for Investors

• Near-term: Despite a consensus miss, sequential growth was robust (+16% product revenue), and FY guidance was raised; watch Q3 seasonality and Q4 re-acceleration as the TV campaign and prescriber expansion mature .
• Mix and pricing: Expect gross‑to‑net near the lower end of the 70–75% range if hospital segment growth persists; this can mute revenue vs script growth; monitor channel mix and 340B exposure .
• Pipeline catalysts: Pivotal ENHANCE dosing consolidation and the subcu pivotal initiation could expand addressable market and convenience; device bridging plan de‑risked by using established auto‑injector platforms .
• Market share: With ~one‑third of new IV starts, incremental share gains remain a key lever; academic and VA penetration plus brand awareness from media investments are supportive .
• Medium-term thesis: Optionality across IV and subcu could uniquely position TG as a dual‑mode anti‑CD20 provider; early autoimmunity CAR‑T efforts (azer‑cel) add longer‑dated upside .
• Risk factors: Payer behavior, competitive dynamics in IV and subcu CD20 segments, and quarter-to-quarter variability in subcu development costs can affect cadence; management reiterated OpEx discipline at ~$300M .
• Trading lens: Near-term stock reaction likely hinges on confidence in H2 ramp vs Q2 miss; raised guidance and clear execution milestones (subcu pivotal start, ENHANCE enrollment) are key catalysts into year-end .

Notes:
* Consensus estimates values retrieved from S&P Global.