Executive Summary / Key Takeaways

• TG Therapeutics has successfully transitioned to a commercial-stage biopharmaceutical company, driven by the rapid uptake and strong performance of BRIUMVI (ublituximab-xiiy) in the competitive relapsing multiple sclerosis (RMS) market.
• BRIUMVI's differentiated profile, including a one-hour, twice-yearly infusion and demonstrated efficacy and safety in clinical trials and real-world use, is fueling significant U.S. net revenue growth, exceeding management's initial expectations and leading to multiple upward guidance revisions.
• The company is strategically investing in BRIUMVI lifecycle management, including developing a subcutaneous formulation targeting less frequent dosing and exploring simplified IV administration regimens, aiming to expand market opportunity and enhance patient experience.
• Leveraging BRIUMVI's commercial success and strengthened financial position, TG Therapeutics is advancing a promising pipeline, notably azer-cel, an allogeneic CD19 CAR T-cell therapy, for autoimmune diseases like progressive MS, representing a potential new avenue for growth.
• While facing intense competition and execution risks inherent in the biopharma sector, the company's focus on differentiated therapies, expanding commercial reach, and disciplined investment positions it for continued growth and potential long-term profitability.

The Ascent of a Focused Biopharma: From Development to Commercial Momentum

TG Therapeutics has undergone a significant transformation, evolving from a development-stage entity into a fully integrated, commercial biopharmaceutical company. This journey, rooted in strategic licensing and focused research, culminated in the U.S. FDA approval of BRIUMVI (ublituximab-xiiy) in December 2022 for relapsing forms of multiple sclerosis (RMS). This pivotal event marked the company's entry into the commercial arena, setting the stage for the rapid growth trajectory observed over the past year. The company's core focus lies in developing novel treatments for B-cell mediated diseases, a therapeutic area with significant unmet medical needs and a dynamic competitive landscape.

The success of BRIUMVI is foundational to TG Therapeutics' current strategy and future aspirations. Positioned within the highly competitive MS market, BRIUMVI competes directly with established anti-CD20 therapies and other disease-modifying treatments (DMTs). The company's strategic response has been to highlight BRIUMVI's differentiated profile and build a robust commercial infrastructure capable of effectively reaching neurologists and infusion centers. This approach has yielded impressive results, with BRIUMVI quickly gaining traction and exceeding initial sales forecasts.

Central to BRIUMVI's competitive edge is its technological differentiation. Ublituximab is a glycoengineered monoclonal antibody targeting CD20. This glycoengineering is designed to enhance antibody-dependent cellular cytotoxicity (ADCC), a mechanism believed to contribute to B-cell depletion. The tangible benefits demonstrated in clinical trials are compelling: the ULTIMATE I and ULTIMATE II Phase 3 trials showed a significant reduction in annualized relapse rates (ARR) to 0.10 in each study compared to teriflunomide. Furthermore, BRIUMVI offers a distinct convenience advantage with its one-hour infusion time every six months, following a brief initial dosing period. Recent data from the ENHANCE study further explores streamlining administration, showing the safety and tolerability of a 30-minute maintenance infusion and the potential for initiating treatment with a single 600mg dose on day one, eliminating the need for a day 15 dose. These operational advantages directly address logistical challenges in infusion centers and patient burden, contributing to its appeal.

The company's R&D efforts are strategically aligned to build upon BRIUMVI's success and expand its market potential. A key initiative is the development of a subcutaneous (subcu) formulation of BRIUMVI. A Phase 1 study is underway, with promising preliminary results suggesting the potential for less frequent dosing, targeting at least every other month or even quarterly administration. This development is crucial for addressing the growing segment of the MS market that prefers self-administered therapies, currently dominated by a monthly subcutaneous option. The company is on track to launch a pivotal trial for subcu BRIUMVI in 2025, aiming to capture a share of this distinct market segment and further differentiate the BRIUMVI franchise.

Beyond MS, TG Therapeutics is leveraging its B-cell expertise and strengthened financial position to explore new therapeutic areas. The acquisition of a worldwide license to azer-cel, an allogeneic CD19 CAR T-cell therapy utilizing Precision BioSciences' (DTIL) ARCUS genome editing technology, represents a significant pipeline expansion into autoimmune diseases. Azer-cel is designed to provide deep, potentially long-lasting B-cell depletion with a single administration, aiming to avoid graft-versus-host disease (GvHD) associated with other cell therapies. The FDA has cleared the IND for azer-cel in progressive forms of MS, a population with limited treatment options, and a Phase 1 study is targeted to launch by early 2025. This program, while early stage, holds the potential to address significant unmet needs and diversify TG Therapeutics' portfolio.

Performance Reflecting Strategic Execution

The financial performance of TG Therapeutics over the past year vividly illustrates the impact of the BRIUMVI launch and the company's strategic execution. U.S. net product revenue has grown rapidly, reaching $119.7 million in the first quarter of 2025, a 137% increase compared to $50.5 million in the first quarter of 2024, and a 16% sequential increase from Q4 2024. This growth is a direct result of increasing market penetration and adoption by healthcare providers and patients. The company's commercial team has successfully expanded its reach, particularly within the hospital setting, which is now the fastest-growing segment and accounts for a significant portion of new patient enrollments. The increasing rate of repeat prescriptions surpassing new ones signals strong patient persistence and growing prescriber confidence.

Other revenue streams, primarily from the ex-U.S. commercialization partnership with Neuraxpharm, also contribute, although they can fluctuate based on milestone achievements. For instance, Q1 2024 included a $12.5 million milestone payment, leading to higher total revenue ($63.5 million) compared to Q1 2025 ($120.9 million), where license/other revenue was $1.2 million, primarily from development services.

Operating expenses have increased as the company invests in commercialization and R&D. Cost of revenue rose to $15.5 million in Q1 2025 from $5.4 million in Q1 2024, reflecting higher sales volume and associated royalties and manufacturing costs. Other research and development expenses increased to $43.0 million in Q1 2025 from $30.3 million in Q1 2024, driven partly by manufacturing investments for the subcutaneous program. Selling, general, and administrative expenses also rose significantly to $50.3 million in Q1 2025 from $34.6 million in Q1 2024, reflecting the build-out of the commercial team and marketing efforts.

Despite these increased investments, the strong revenue growth has propelled TG Therapeutics to profitability. The company reported GAAP net income of $5.1 million in Q1 2025, a notable shift from a net loss in the prior year period. It also achieved its first operationally cash flow positive quarter in Q2 2024 and generated cash flow from operations in 2024 (excluding inventory/share repurchases), a trend expected to continue in 2025.

As of March 31, 2025, TG Therapeutics held a solid liquidity position with $276.2 million in cash, cash equivalents, and short-term investment securities. This, combined with projected BRIUMVI revenues, is anticipated to provide sufficient liquidity for more than twelve months. The recent refinancing of debt with a $250 million term loan facility provides financial flexibility and supports the authorized $100 million share repurchase program, signaling management's confidence in future cash flow generation and commitment to shareholder value.

Competitive Landscape and Strategic Positioning

The MS market is intensely competitive, featuring established players with deep pockets and diversified portfolios like AbbVie (ABBV), Merck (MRK), Gilead Sciences (GILD), and Bristol-Myers Squibb (BMY), as well as other companies focused on MS therapies. While these larger companies operate across broader therapeutic areas (oncology, immunology, antivirals), they compete directly or indirectly with TG Therapeutics' offerings.

In the anti-CD20 space, BRIUMVI competes primarily with Ocrevus (Roche/Genentech (RHHBY)) and Kesimpta (Novartis (NVS)). Ocrevus, an IV infusion, and Kesimpta, a self-administered subcutaneous injection, are significant players. BRIUMVI differentiates itself from Ocrevus primarily on infusion time (one hour vs. Ocrevus's 3.5 hours, or potentially shorter with a higher volume subcu version) and potentially a differentiated safety/tolerability profile, particularly concerning infusion-related reactions and "wearing off" effects reported by some patients on other CD20s. From Kesimpta, BRIUMVI differentiates as an IV option for patients preferring clinic-based administration, while the developing subcu BRIUMVI aims to compete directly in the self-administered space, potentially offering less frequent dosing (every other month or quarterly target vs. monthly).

TG Therapeutics' strategic positioning leverages BRIUMVI's unique attributes. The one-hour infusion is a key selling point for both patients and busy infusion centers. The robust five-year efficacy and safety data from the ULTIMATE trials provide long-term reassurance to prescribers and patients. The company is actively using real-world evidence and expanding its commercial team to drive deeper penetration, particularly in academic and hospital settings, which are crucial for capturing market share. The VA contract, making BRIUMVI the preferred anti-CD20 for veterans, further enhances access and visibility.

Financially, while larger competitors like AbbVie and Merck boast significantly higher revenues, profitability margins (Gross, Operating, Net), and cash flow generation due to their scale and diversified portfolios, TG Therapeutics demonstrates superior recent revenue growth rates driven by its successful launch. TGTX's TTM Gross Profit Margin of 87.43% is competitive, though its Operating (15.48%) and Net (10.13%) margins reflect ongoing significant investments in commercialization and R&D compared to more mature, larger peers with established infrastructure. The Debt/Equity ratio of 1.07 reflects the recent financing to support growth and shareholder return.

The planned subcu formulation directly addresses a competitive gap and aims to position BRIUMVI to compete across both IV and self-administered segments. The azer-cel program represents a strategic move into the emerging CAR T space for autoimmune diseases, potentially offering a novel mechanism of action compared to existing or pipeline B-cell therapies, although it faces competition from other cell therapies and novel approaches being explored by larger players.

Outlook and Risks

TG Therapeutics' outlook is characterized by continued strong growth expectations for BRIUMVI and progress in advancing its pipeline. The company has raised its full-year 2025 U.S. net revenue guidance for BRIUMVI to approximately $560 million, up from previous targets, and is targeting $135 million in Q2 2025 revenue. This guidance is based on assumptions of continued market penetration, increasing prescriber adoption across all segments, strong patient persistence, and the impact of expanded marketing efforts, including direct-to-patient initiatives.

Total OpEx (excluding non-cash items) for 2025 is guided at approximately $300 million, reflecting ongoing investments in the commercial build-out, marketing, and R&D programs (subcu, azer-cel, IV enhancements). While cost of revenue is expected to modestly increase as pre-approval inventory is depleted, impacting gross margin percentage slightly starting in Q2 2025, the overall financial trajectory is positive, with expectations of maintaining operational profitability and generating cash flow from operations in 2025.

Despite the positive momentum, TG Therapeutics faces significant risks. The highly competitive MS market means continued pressure on pricing, market access, and the need for ongoing differentiation. The launch of new competitive products, including potential higher-dose or alternative formulations of existing therapies or novel mechanisms like BTK inhibitors (though potentially less impactful in RMS), could affect market share gains. Regulatory risks persist, including potential post-marketing requirements for BRIUMVI, the need for successful outcomes in pivotal trials for the subcu formulation and IV enhancements, and the uncertain path for azer-cel in autoimmune indications. Manufacturing reliance on third parties, including single-source suppliers, poses supply chain risks. The company's ability to effectively manage its growth, integrate new personnel, and control expenses while investing heavily is crucial. Furthermore, the level of indebtedness, while strategically utilized, introduces financial risk if revenue growth slows or covenants are breached.

Conclusion

TG Therapeutics has successfully navigated the challenging transition to a commercial-stage biopharmaceutical company, establishing a strong foothold in the competitive MS market with BRIUMVI. The drug's differentiated profile, particularly its convenient one-hour infusion and robust clinical data, resonates with healthcare providers and patients, driving significant revenue growth that has consistently exceeded expectations. This commercial success provides the financial foundation for strategic investments in BRIUMVI lifecycle management, including the promising subcutaneous formulation, and the advancement of a pipeline focused on B-cell mediated diseases, notably the innovative azer-cel CAR T program for autoimmune indications.

While the competitive landscape remains intense and execution risks are inherent, TG Therapeutics' focused strategy, technological differentiation, expanding commercial capabilities, and disciplined investment approach position it for continued growth. The upward revisions in revenue guidance and the move to operational profitability underscore the positive momentum. For investors, the story is one of a company leveraging its first commercial success to build a broader franchise and pipeline, aiming to become a significant player in B-cell diseases and generate long-term shareholder value, contingent on continued strong execution and successful pipeline development.