Executive Summary / Key Takeaways

• Dominant Commercial Trajectory: BRIUMVI, TG Therapeutics' flagship anti-CD20 therapy for relapsing multiple sclerosis (RMS), continues its robust commercial growth, with Q2 2025 U.S. net product revenue reaching $138.8 million, a 91% year-over-year increase. The company has raised its full-year 2025 U.S. net revenue guidance to approximately $570-$575 million, driven by strong market penetration and patient persistence.
• Strategic Market Expansion: TG Therapeutics is actively enhancing BRIUMVI's market reach through the development of a subcutaneous (SubQ) formulation, with a pivotal Phase 3 trial commencing in Q3 2025 targeting every-other-month or quarterly dosing. This initiative aims to capture the 35-40% of the anti-CD20 market preferring self-administration, uniquely positioning BRIUMVI with both IV and SubQ options.
• Pipeline Innovation in Autoimmune Diseases: Beyond MS, the company is advancing azer-cel, an allogeneic CD19 CAR T-cell therapy, into a Phase 1 study for progressive MS, with the first patient dosed in August 2025. Exploratory trials for BRIUMVI in Myasthenia Gravis are also underway, signaling a broader strategic focus on B-cell mediated autoimmune conditions.
• Differentiated Technology and Long-Term Safety: BRIUMVI's glycoengineered anti-CD20 monoclonal antibody offers a compelling profile, supported by five-year data showing 92% of patients free from disability progression and an annualized relapse rate of 0.02. This, combined with a convenient one-hour, twice-a-year infusion, underpins its competitive advantage and growing prescriber confidence.
• Solid Financial Foundation: With $278.9 million in cash, cash equivalents, and investment securities as of June 30, 2025, and a full-year 2025 operating expense guidance of approximately $300 million (excluding non-cash items), TG Therapeutics maintains a strong financial position to fund its commercialization efforts and pipeline advancements.

Setting the Stage for a Biopharma Challenger

TG Therapeutics, Inc. (TGTX) has transformed into a fully-integrated, commercial-stage biopharmaceutical company, singularly focused on addressing B-cell mediated diseases. Its journey, marked by a pivotal merger in 2010 and the subsequent exclusive licensing of ublituximab in 2012, culminated in the FDA approval of BRIUMVI (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS) in December 2022. This approval launched TGTX into a highly competitive, yet rapidly expanding, market for MS therapies.

The company's overarching strategy is to establish BRIUMVI as the preferred anti-CD20 therapy in RMS, leveraging its differentiated profile and expanding its utility into other autoimmune indications. This ambition is set against a backdrop of a CD20 class that generates over $8 billion in annual U.S. MS sales and continues to grow, attracting numerous competitors. TGTX's foundational strength lies in its commitment to improving the patient experience and its innovative approach to B-cell targeting, which it believes will drive sustained market leadership.

Technological Edge and Pipeline Innovation: Shaping Future MS Care

At the heart of TG Therapeutics' competitive stance is its core technology: BRIUMVI's glycoengineered anti-CD20 monoclonal antibody. This specific engineering provides tangible benefits, driving variations in efficacy and tolerability compared to other CD20 therapies. Real-world experiences have highlighted instances where patients switching from prior anti-CD20 treatments to BRIUMVI saw unwanted effects resolve or not recur, underscoring the clinical significance of these structural and mechanistic differences. For investors, this differentiation translates into a stronger competitive moat, supporting market acceptance and premium positioning. The company has also secured robust intellectual property, with patents protecting BRIUMVI through 2042, including a composition of matter covering its glycoengineered attributes, ensuring long-term revenue protection.

Beyond the current intravenous (IV) formulation, TG Therapeutics is aggressively pursuing pipeline innovations to expand BRIUMVI's market potential and enhance patient convenience. A pivotal Phase 3 trial for a subcutaneous (SubQ) formulation of BRIUMVI is set to commence in the coming weeks of August 2025. This program will evaluate two dosing schedules—every other month and quarterly—with the primary endpoint of demonstrating non-inferior exposure compared to the approved IV dosing. This initiative is critical as 35% to 40% of the anti-CD20 dynamic market segment currently prefers a self-administered option. If successful, SubQ BRIUMVI, administered via a standard auto-injector, would uniquely position TG Therapeutics as the only company offering both IV and self-administered options, simplifying treatment decisions and significantly expanding its addressable market. The company anticipates completing enrollment in 2026, filing a Biologics License Application (BLA) in 2027, and launching SubQ BRIUMVI, pending approval, in 2028.

Further enhancing the IV BRIUMVI experience, the ENHANCE trial is exploring a consolidated Day 1 and Day 15 dosing regimen into a single 600mg infusion on Day 1. This streamlined approach aims to eliminate the need for a second infusion in the first two weeks, offering a meaningful convenience benefit for patients and infusion centers. Pivotal data from this program is expected in 2026, with a goal for an updated label in 2027. Preliminary data from the ENHANCE study has also shown the safety and tolerability of a faster 30-minute maintenance infusion, and that B-cell depleted patients could switch from another anti-CD20 to BRIUMVI without the four-hour introductory dose. These enhancements are designed to maintain BRIUMVI's best-in-class profile and reinforce its value proposition.

Looking further into the future, TG Therapeutics is advancing azer-cel (azercabtagene zapreleucel), an investigational allogeneic (off-the-shelf) CD19-directed CAR T-cell therapy. Licensed from Precision BioSciences (PBI), azer-cel utilizes proprietary ARCUS genome editing technology and is designed to minimize graft-versus-host disease (GvHD). A Phase 1 study for progressive forms of MS, a patient population with limited treatment options and poor prognosis, has dosed its first patient in August 2025. This early-stage program focuses on dose finding and conditioning regimens, with the ultimate goal of slowing or stopping disease progression. While early, this represents a significant long-term growth opportunity, as the company sees "great potential across multiple indications" for CAR-Ts in autoimmune diseases. Additionally, exploratory clinical trials for BRIUMVI in Myasthenia Gravis (MG) commenced in January 2025, exploring its potential as a cost-effective, highly active, and convenient treatment option in this autoimmune condition.

The BRIUMVI Growth Engine: Commercial Momentum and Market Penetration

TG Therapeutics' commercial strategy for BRIUMVI has yielded exceptional results, consistently exceeding expectations since its U.S. launch in January 2023. In the second quarter of 2025, U.S. net product revenue for BRIUMVI reached $138.8 million, marking a robust 91% increase compared to Q2 2024 and a 16% sequential growth over Q1 2025. Year-to-date, for the six months ended June 30, 2025, product revenue stood at $258.5 million, more than doubling the $123.1 million reported in the comparable period of 2024. This strong performance has led the company to raise its full-year 2025 U.S. net revenue guidance for BRIUMVI to approximately $570-$575 million.

The growth is multifaceted, driven by increasing adoption among healthcare providers and accelerating patient interest. Q2 2025 saw the highest volume of new patient enrollments into the company's hub since launch, indicating expanding reach and awareness. Importantly, repeat prescriptions have now surpassed new prescriptions, a key inflection point signaling strong persistence trends at week 24 and preliminary positive data at week 48. The hospital segment is the fastest-growing area, contributing approximately 60% of enrollments in March 2025 and accounting for about 55% of the overall business. This expansion, however, brings increased exposure to government-mandated discounting, which contributed to a gross-to-net closer to 70% in Q2 2025, though the full-year guidance remains at 70-75%.

To further fuel this momentum, TG Therapeutics launched its first national television campaign in Q2 2025, complemented by a full digital strategy. Early results are promising, with measurable upticks in patient awareness, website traffic, and physician reports of patients requesting BRIUMVI by name. Internationally, BRIUMVI is gaining traction through its partnership with Neuraxpharm, which launched the product in Germany in February 2024 and has since expanded to other EU countries and the UK. License, milestone, royalty, and other revenue, primarily from this partnership, contributed $2.3 million in Q2 2025.

Financial Health and Capital Allocation

TG Therapeutics maintains a solid financial foundation to support its ambitious growth plans. As of June 30, 2025, the company held $278.9 million in cash, cash equivalents, and investment securities, providing sufficient liquidity for more than twelve months. This strong cash position is crucial as the company continues to invest in commercialization and R&D.

Operating expenses, excluding non-cash compensation, totaled approximately $71 million in Q2 2025. While this represents an increase from Q2 2024, it reflects strategic investments in SubQ BRIUMVI development and commercial efforts. The company expects full-year 2025 operating expenses to remain around $300 million, demonstrating disciplined spending. Net income for Q2 2025 was $28.2 million, or $0.17 per diluted share, a significant improvement from $6.9 million in Q2 2024. Although operating cash flow was negative in the first six months of 2025, this was primarily due to increases in accounts receivable and inventory purchases, reflecting strong sales growth and strategic inventory build-up.

The company's debt structure includes a $250 million Initial Term Loan secured in August 2024, maturing in August 2029, with scheduled amortization payments beginning in June 2028. This loan provides capital flexibility while managing interest expense, which increased to $6.7 million in Q2 2025 due to this facility. Furthermore, TG Therapeutics initiated a $100 million share repurchase program in August 2024, repurchasing $6.9 million in Q2 2025, signaling confidence in its valuation and commitment to shareholder returns. To mitigate supply chain risks and support growth, the company has also engaged FUJIFILM Diosynth Biotechnologies as a secondary U.S.-based manufacturer for BRIUMVI, complementing its existing partnership with Samsung Biologics.

Competitive Landscape: A Differentiated Play in a Crowded Field

TG Therapeutics operates in a highly competitive biopharmaceutical market, particularly within the B-cell mediated disease space. Key competitors include established players like AbbVie Inc. (ABBV), Gilead Sciences, Inc. (GILD), Bristol-Myers Squibb Company (BMY), and Merck & Co., Inc. (MRK), all possessing significantly greater financial, R&D, and commercialization resources. However, TGTX has carved out a distinct position through BRIUMVI's differentiated profile and strategic focus.

TGTX's gross profit margin of 86.96% (TTM) stands strong, comparing favorably to AbbVie (70%), Gilead (78%), Bristol-Myers Squibb (57%), and Merck (76%). This indicates efficient cost management relative to its revenue base, reflecting the specialized nature of its product. While TGTX's operating and net profit margins (18.91% and 13.31% TTM, respectively) are competitive, larger players like Merck (32% operating, 27% net) often benefit from greater scale and diversified portfolios. TGTX's current ratio of 4.02 (TTM) suggests robust short-term liquidity, exceeding that of AbbVie (0.66), Gilead (1.60), Bristol-Myers Squibb (1.25), and Merck (1.36).

In the anti-CD20 market, BRIUMVI's competitive advantage is clear: a convenient twice-a-year, one-hour infusion, backed by compelling five-year safety and efficacy data. This differentiates it from existing IV options and positions it strongly against emerging self-administered therapies. TGTX estimates it captures nearly 1 in every 3 new IV anti-CD20 patients, demonstrating significant traction. Management reports minimal enthusiasm or impact from new competitive entrants like Zunovo, further solidifying BRIUMVI's market acceptance. The company also observes a "healthy amount" of patients switching to BRIUMVI from competitors like Ocrevus and Kesimpta, a trend consistent since launch, suggesting that BRIUMVI's unique profile resonates with patients seeking better tolerability or efficacy.

TGTX's strategic move into subcutaneous BRIUMVI aims to directly address the 35-40% of the anti-CD20 market that prefers self-administration, a segment currently dominated by a single competitor. By offering both IV and SubQ options, TGTX seeks to simplify treatment decisions for providers and patients, aiming to become the anti-CD20 therapy of choice. This expansion, coupled with pipeline advancements like azer-cel in progressive MS, positions TGTX to capture new market segments where larger competitors may have less specialized offerings.

The broader industry landscape presents both opportunities and challenges. While AI in drug discovery (indirectly supported by infrastructure investments) could accelerate TGTX's R&D, larger competitors may capitalize more due to their extensive resources. Healthcare cost containment measures, including the Inflation Reduction Act (IRA) and potential Most Favored Nation policies, could exert downward pressure on drug pricing, impacting all players, including TGTX. However, TGTX's relatively lower cost of goods for BRIUMVI may provide some resilience against these pressures.

Risks and Considerations

Despite its strong momentum, TG Therapeutics faces several inherent risks. The success of BRIUMVI and its pipeline candidates hinges on continued market acceptance and favorable reimbursement policies, which can be influenced by evolving healthcare legislation and third-party payor initiatives. Post-marketing requirements and the potential for unexpected side effects as BRIUMVI is used more widely could lead to labeling restrictions or even market withdrawal.

The company's reliance on third parties for manufacturing, clinical trials, and supply chain management introduces operational risks. While TGTX has diversified its manufacturing with FUJIFILM Diosynth Biotechnologies, disruptions from sole-source suppliers remain a concern. The development of the SubQ formulation presents unique scientific and regulatory challenges, including ensuring non-inferior exposure and managing potential injection site reactions or immunogenicity. Furthermore, the early-stage nature of azer-cel and BRIUMVI in MG means their commercial viability is uncertain, requiring substantial R&D investment without guaranteed returns. The rapidly evolving regulatory landscape for AI technologies and the broader macroeconomic environment, including geopolitical conflicts and high interest rates, could also impact TGTX's business and financial performance.

Conclusion

TG Therapeutics stands at a pivotal juncture, having successfully transitioned into a commercial-stage biopharmaceutical company with its flagship product, BRIUMVI. The impressive commercial performance, marked by significant revenue growth and increasing market penetration in the RMS space, validates the company's focused strategy and the differentiated value of its glycoengineered anti-CD20 therapy. With a robust pipeline aimed at enhancing the BRIUMVI patient experience through subcutaneous and simplified IV dosing, and expanding into new autoimmune frontiers with azer-cel and Myasthenia Gravis, TG Therapeutics is actively building multiple avenues for sustained growth.

The company's disciplined financial management, evidenced by its strong liquidity and controlled operating expenses, provides a solid foundation for these strategic investments. While operating in a highly competitive environment, BRIUMVI's unique profile and TGTX's innovative approach to B-cell mediated diseases position it as a formidable challenger. The long-term investment thesis for TG Therapeutics is compelling, predicated on its ability to continue driving BRIUMVI's market ascent while strategically expanding its technological leadership and product offerings across the autoimmune landscape.