TGTX

• Corporate Strategy and Core Franchise Progress

  • Briumvi's commercial success is serving as a durable foundation to expand TG Therapeutics into a multi-product biotech focused on repeated innovation and shareholder value creation
  • The company's top priority remains establishing Briumvi as the leading anti-CD20 therapy for relapsing multiple sclerosis, with meaningful progress toward this goal in Q2 2026
  • Capital allocation prioritizes long-term value creation: investment in Briumvi commercialization and pipeline expansion, strategic business development, selective share repurchases, with every investment evaluated on value per dollar deployed

• Commercial Operational Highlights

  • Briumvi delivered another record quarter, exceeding prior guidance, with record new patient starts, expanding physician adoption, higher repeat prescribing, and treatment persistence that exceeds management expectations
  • A growing share of new Briumvi patients are treatment-naive (rather than switching from competing therapies), a leading indicator of long-term franchise strength
  • Real-world data confirms that patients switching from competing anti-CD20 therapies to Briumvi maintain strong disease control and report improved convenience, tolerability, and treatment satisfaction
  • Direct-to-consumer (DTC) marketing pilot results were positive, with expansion planned for H2 2026 to increase patient awareness and drive growth
  • Over 30,000 patients globally have been prescribed Briumvi as of Q2 2026, with patent protection extending into the 2040s

• Pipeline and Product Innovation Highlights

  • Announced positive top-line Phase III results for the ENHANCE study, demonstrating Briumvi can be initiated via a single 600mg IV infusion, replacing the current two-dose (Day 1/Day 15) schedule. If approved (expected mid-2027), the simplified schedule will reduce treatment burden and remove a key barrier to switching from competing therapies.
  • Reported positive Phase I bioavailability data for proprietary subcutaneous (SubQ) Briumvi, supporting the ongoing Phase III study evaluating quarterly dosing. Top-line Phase III results are expected around year-end 2026 or early 2027. A successful SubQ launch would allow TG to enter the 35-40% of the anti-CD20 RMS market that is currently self-administered, more than doubling Briumvi's addressable market.
  • Expanded Briumvi into new indications: announced encouraging preliminary Phase I data in myasthenia gravis (MG) and initiated a registration-directed Phase II study; also initiated a Phase II study in treatment-resistant schizophrenia, evaluating the hypothesis that a subset of cases has an autoimmune component. Investments in these new indications are modest, with significant upside if clinical hypotheses hold.
  • Allogeneic CD19 CAR-T program Azercel, for progressive multiple sclerosis, has enrolled over 20 patients, and the study has been expanded to include additional B-cell mediated diseases (MG, CIDP, NMO). A clinical update is expected in H2 2026.

• Full-year 2026 U.S. Briumvi net revenue guidance was raised to $890 million to $905 million, up from prior guidance, reflecting stronger-than-expected H1 performance and commercial fundamentals
• Full-year 2026 total global revenue guidance is set at approximately $950 million, with the increase driven by stronger U.S. performance and milestone/royalty revenue from ex-U.S. partner operations
• Total 2026 operating expenses (excluding stock-based compensation) are expected to be $350 million to $400 million, plus an additional $100 million for SubQ and secondary manufacturing-related R&D expenses, consistent with prior projections
• Management expects Q4 2026 to drive the majority of H2 2026 growth, positioning TG to exit 2026 with a $1 billion+ annualized U.S. revenue run rate, with Q3 2026 expected to see seasonal flattish performance typical for the MS space
• Management projects 2027 will deliver Briumvi's first $1 billion+ U.S. revenue year, supported by the potential approval of the simplified IV initiation schedule in mid-2027 and eventual SubQ launch
• No formal 2027 guidance has been issued as of the Q2 call

TG Therapeutics' primary product segment is the Briumvi (BrionV) franchise for relapsing multiple sclerosis (RMS), which generated all core product revenue in Q2 2026. U.S. net product revenue for Briumvi was $228 million, representing 96.6% of total Q2 product revenue, with 64% year-over-year growth and 17% quarter-over-quarter growth. Total net product revenue (including ex-U.S. partner sales) was $236 million, 98.3% of total Q2 revenue of $240 million (which also includes $4.5 million of license, royalty, and other revenue). U.S. Briumvi gross margin held steady at 87%, and total company gross margin for the quarter was 83%, in line with expectations. Total operating income for Q2 was $21.7 million, with underlying operating income (excluding one-time manufacturing charges) of $76 million. Net income was $7.8 million ($0.05 per diluted share), or $62 million excluding manufacturing charges, reflecting strong underlying earnings power. All pipeline programs (subcutaneous Briumvi, Azercel, new indication studies) are currently R&D investments with no revenue contribution as of Q2 2026.

• All forward-looking statements (including pipeline progress, revenue projections, and regulatory approvals) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings
• There is clinical trial execution and outcome risk: new indication studies (myasthenia gravis, schizophrenia) and the SubQ Briumvi Phase III trial may fail to meet efficacy or safety endpoints, preventing approval or commercial launch
• Pricing and contracting uncertainty exists for the potential SubQ Briumvi launch, as it will be a Part D product with different market dynamics than the current IV physician-administered product
• The RMS anti-CD20 market is highly competitive, with major competitors (including Roche's Ocrevus) also pursuing market share gains and SubQ formulation launches, which could impact Briumvi's growth trajectory
• Early stage pipeline assets (including Azercel CAR-T and new indications for Briumvi) may not yield commercially successful products, even with positive preliminary data
• Business development transactions carry inherent integration and valuation risk, and there is no guarantee that attractive opportunities will be identified or completed on terms that create shareholder value

Q: What is the competitive dynamic with Roche's Ocrevus, and are Briumvi share gains coming from Ocrevus switches or treatment-naive patients? What threshold for the schizophrenia Phase II study would justify advancing to a larger Phase III trial? / A: TG continues to grow new patient business to record levels despite increased competition from Roche's new Ocrevus formulations. Share gains are coming from both switches from Ocrevus and an increasing share of treatment-naive patients, with growing naive share reflecting increasing physician confidence in the Briumvi brand. Even as Roche encourages switches from its IV Ocrevus to its own SubQ formulation, TG continues to see strong net switching from Ocrevus to Briumvi. The schizophrenia study uses a two-stage Fleming design that sets a pre-specified response rate hurdle against historical placebo rates. If the trial meets the response hurdle, TG will advance to a larger study; if not, biomarker analysis will be used to identify a potential responsive subgroup for additional testing.\n\nQ: How will the IV Briumvi market grow after SubQ Briumvi is commercialized, and what new indications were added to the Azercel trial? / A: TG's strategy is to offer patients choice of administration route: IV for the physician-administered segment and SubQ for the self-administered segment, rather than cannibalizing existing IV sales. Management views the two segments as fundamentally distinct markets, and SubQ entry will expand Briumvi's total addressable market rather than displacing existing IV demand. The company remains fully committed to supporting the IV Briumvi franchise long-term. The Azercel trial was expanded beyond multiple sclerosis to include four additional B-cell mediated diseases: myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and neuromyelitis optica (NMO).\n\nQ: What is TG's appetite for business development amid mid-cap biotech consolidation? What is the current status of gross-to-net expectations for Briumvi? / A: Gross-to-net retention for Briumvi remains in the mid-60% range, unchanged from prior guidance and in line with management expectations. TG is actively evaluating business development opportunities, but is not pursuing large-scale consolidation. Management prioritizes adding high-value single assets or small companies that align with the company's core focus areas (expanding Briumvi and Azercel into new indications, adding complementary mechanisms in autoimmune disease) and create shareholder value without excessive balance sheet risk. As Briumvi generates growing predictable cash flow with patent protection through the 2040s, TG has flexibility to pursue attractive opportunities.\n\nQ: What can we expect from the DTC campaign expansion, and what is driving Briumvi's better-than-expected treatment persistence? / A: Early results from the DTC pilot have been positive, with all leading indicators trending in the right direction, giving TG confidence to expand the campaign. Expansion will include an omni-channel approach across digital, linear TV, connected TV, and social media to build broader patient awareness. Higher-than-expected persistence is driven by strong patient outcomes on Briumvi: patients who experience good disease control and positive tolerability stay on therapy longer. This trend is very encouraging for long-term franchise value, though the brand is still early in its lifecycle so TG will continue tracking persistence closely.