Executive Summary / Key Takeaways

• Profitable Commercial-Stage Inflection: TG Therapeutics has achieved six consecutive quarters of profitability driven by BRIUMVI's rapid market penetration, with Q3 2025 revenue up 93% year-over-year to $161.7 million and full-year guidance raised to approximately $585 million, demonstrating that the company has crossed from cash-burning biotech to self-funding growth.

• The Subcutaneous Market Doubler: Management is reinvesting profits into a subcutaneous BRIUMVI formulation that could capture 35% to 40% of the anti-CD20 market that prefers self-administration, potentially nearly doubling the addressable market by 2028 and positioning TGTX as the only company offering both IV and self-administered CD20 options.

• Single-Product Concentration Risk: With BRIUMVI representing nearly all revenue, the company faces heightened vulnerability to competitive threats, regulatory changes, or safety signals, while a 100% tariff on imported pharmaceuticals effective October 2025 directly threatens the South Korea-manufactured drug's cost structure.

• Disciplined Capital Allocation: Management has completed a $100 million share repurchase program and authorized another $100 million, signaling confidence in the stock's value while maintaining a high return-on-investment threshold for pipeline spending, using internal cash generation rather than dilutive equity raises.

• Critical Execution Window: Success over the next 18 months hinges on subcutaneous Phase 3 enrollment completion (targeted H1 2026), ENHANCE study data (mid-2026), and competitive response from Roche's pipeline, with any delays or negative readouts likely to compress the stock's valuation multiple.

Setting the Scene: From Oncology Pivot to B-Cell Dominance

Founded in March 2010 from a merger of Manhattan Pharmaceuticals and Ariston Pharmaceuticals, TG Therapeutics commenced operations in January 2012 with a singular focus on B-cell mediated diseases. This strategic clarity has shaped every subsequent decision, most critically the 2022 withdrawal of the umbralisib oncology program to concentrate resources on BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody. The FDA approved BRIUMVI for relapsing forms of multiple sclerosis (RMS) in December 2022, with U.S. commercial launch following in January 2023 and European approval via partner Neuraxpharm in June 2023.

The company operates in the nearly $10 billion annual U.S. anti-CD20 market for multiple sclerosis, where approximately half of all patients remain on alternative disease-modifying therapies, indicating substantial headroom for penetration. TGTX's positioning is that of a focused, agile competitor against pharmaceutical giants, leveraging a glycoengineered antibody with a differentiated infusion profile. The B-cell therapy segment encompasses all company activities, generating revenue from BRIUMVI product sales and Neuraxpharm partnership payments, creating a pure-play exposure to the anti-CD20 competitive dynamics.

Technology, Products, and Strategic Differentiation

BRIUMVI's Core Advantage: Speed and Durability

BRIUMVI's glycoengineered design enables a one-hour infusion every 24 weeks following a starting dose, materially faster than competitors' multi-hour infusion requirements. Infusion center throughput directly impacts healthcare economics—shorter sessions mean higher patient capacity and lower operational costs for providers. Real-world data from the ENABLE observational study demonstrates consistent efficacy and infusion tolerability, while six-year data presented at ACTRIMS 2025 showed nearly 90% of patients remaining free from disability progression with an annualized relapse rate of just 0.012 in the sixth year, reinforcing the durability argument.

The clinical profile translates to commercial momentum: management estimates that nearly one in three new patients initiating IV anti-CD20 therapy were prescribed BRIUMVI in Q2 2025. This share gain is supported by a specific switching advantage—in a subset of 19 patients previously treated with Roche (RHHBY)'s Ocrevus who experienced a "wearing off effect" between infusions, 16 (85%) did not report this effect after switching to BRIUMVI. The value proposition centers on a convenient twice-yearly, one-hour infusion backed by six years of consistent efficacy and safety data, creating a compelling option for both treatment-naïve patients and switchers.

Pipeline Expansion: The Subcutaneous Opportunity

The subcutaneous ublituximab program represents TGTX's most significant strategic bet. A true subcutaneous product with auto-injector compatibility designed for self-administration, it targets the 35% to 40% (and potentially growing to 50%) of the anti-CD20 market that prefers subcutaneous options. Management expects enrollment to finish in the first half of 2026, with top-line pivotal data in late 2026 or early 2027, potentially enabling approval and launch in 2028. If approved, subcu BRIUMVI would position TGTX as the only company offering both IV and self-administered CD20 options, a unique competitive advantage.

The dosing schedule—once every other month or once quarterly—would cut injections in half compared to the currently available monthly subcutaneous option, offering a meaningful convenience benefit. Preliminary bioavailability studies support at least every-other-month dosing, and the company plans to bridge from vial-based injections to a standard auto-injector. This program could nearly double BRIUMVI's addressable market, transforming TGTX from a niche infusion player into a comprehensive B-cell therapy provider.

Life Cycle Management: ENHANCE and New Indications

The ENHANCE study explores consolidating the Day 1 and Day 15 infusions into a single 600-milligram infusion, eliminating the need for a second visit in the first two weeks. Patient enrollment for the randomized Phase 3 cohort commenced in August 2025 and has already been completed, with data expected by mid-2026 and potential launch in 2027. This simplified approach offers meaningful convenience for patients and infusion centers, with management noting high customer excitement.

Beyond MS, TGTX is exploring BRIUMVI in Myasthenia Gravis (MG), having treated a small number of patients with encouraging results and enrolling the first trial patients in January 2025. MG represents a potentially interesting expansion opportunity where management believes there is room for a highly active, convenient, and cost-effective treatment option. Additionally, the company is developing azer-cel, an allogeneic CD19 CAR T therapy for progressive forms of MS, dosing the first patient in August 2025. While still early and focused on dose finding, management believes this could be life-changing for progressive MS patients who have limited options.

Financial Performance & Segment Dynamics

Revenue Growth as Evidence of Commercial Execution

Q3 2025 product revenue of $159.3 million, up 91% year-over-year, demonstrates accelerating market penetration. U.S. BRIUMVI sales reached $152.9 million, growing 16% quarter-over-quarter for two consecutive quarters, while ex-U.S. sales to Neuraxpharm contributed $6.4 million. The nine-month revenue of $417.8 million represents a 103% increase over 2024, with management raising full-year U.S. guidance from an initial $525 million to approximately $585 million across three consecutive revisions. This guidance raising pattern—$525M → $560M → $575M → $585M—signals consistent outperformance versus internal targets and Street expectations.

The revenue composition reveals a pure-play model: BRIUMVI product sales dominate, while license, milestone, royalty, and other revenue contributed $2.4 million in Q3, including $1.5 million in royalties from Neuraxpharm. The Neuraxpharm agreement, signed in July 2023, included a $140 million upfront payment and a $12.5 million milestone upon EU launch, with eligibility for up to an additional $492.5 million in milestones and tiered double-digit royalties up to 30%. This partnership validates BRIUMVI's global potential while providing non-dilutive capital.

Margin Expansion and Profitability Inflection

The company achieved its sixth consecutive quarter of profitability in Q3 2025, with net income of $390.9 million (though this includes a significant tax benefit from deferred tax asset valuation allowance release). Operating margins reached 18.16% on a trailing twelve-month basis, while gross margins stand at 85.34%, comparable to larger biopharma companies.

The shift to profitability transforms TGTX from a capital markets-dependent biotech into a self-funding enterprise that can invest in pipeline expansion without diluting shareholders.

Noncash compensation expense increased in Q3 2025 due to performance-based awards and higher stock prices, reflecting management's confidence in sustained performance. R&D expenses rose from subcutaneous manufacturing development and clinical trial costs, while SG&A increased from commercial expansion and marketing investments, including a national television campaign launched in Q3 2025. Despite these investments, management maintained full-year operating expense guidance of $300-320 million, demonstrating spending discipline.

Balance Sheet and Capital Allocation

As of September 30, 2025, TGTX held $178.3 million in cash, cash equivalents, and investment securities, with management stating these resources combined with projected revenues will meet liquidity needs for more than twelve months.

The company has no committed external funding beyond a $250 million term loan facility with Blue Owl (OWL), and aggregate non-cancelable purchase commitments total $202 million through 2027.

Most notably, TGTX completed its initial $100 million share repurchase program in Q3 2025, buying back 3.5 million shares at an average price of approximately $28.50, and authorized another $100 million program in September 2025. This signals management's belief that internal investment opportunities must clear a high ROI hurdle, and when they don't, returning capital to shareholders is preferable to empire-building. The buyback activity at prices below the current $30.76 level suggests management views the stock as undervalued relative to long-term prospects.

Outlook, Management Guidance, and Execution Risk

Revenue Trajectory and Market Share Ambitions

Management's guidance implies Q4 2025 U.S. BRIUMVI revenue of approximately $173 million, representing 14% sequential growth driven by patient retention, field expansion, and media investments. Adam Waldman stated BRIUMVI is "on track to become a multibillion-dollar brand in RMS," supported by a growing prescriber base across academic centers and community neurology practices. The anti-CD20 class's $10 billion annual U.S. sales and the fact that half of MS patients remain on non-CD20 therapies provide a clear runway.

The commercial infrastructure is scaling methodically, with the national television campaign in Q3 2025 showing early indicators of elevated branded search activity, website traffic, and patient brand awareness. This demonstrates a shift from physician-focused promotion to direct patient engagement, potentially accelerating new patient starts and reducing sales force dependency.

Pipeline Milestones and Timing Risk

The subcutaneous program's timeline is aggressive: enrollment completion targeted for H1 2026, top-line data in late 2026 or early 2027, and potential launch in 2028. The ENHANCE study's single-infusion data expected by mid-2026 could enable a 2027 launch. These timelines create a critical execution window where any delays would extend the period of single-product dependency and expose TGTX to competitive threats without the diversification benefit.

Michael Weiss frames the strategy as "all about ROI and risk reward," noting that passed opportunities "didn't meet the threshold." This disciplined approach is evident in the decision to return capital via buybacks rather than pursue marginal acquisitions, but it also means the company is betting heavily on internal pipeline execution rather than external diversification.

Risks and Asymmetries

Single-Product Dependency and Competitive Pressure

BRIUMVI represents nearly all revenue, creating concentration risk that magnifies any safety signal, reimbursement change, or competitive entry. Roche's pipeline presents the most credible threat: a new MS candidate met Phase 3 endpoints in November 2025, potentially launching as a direct competitor with Roche's superior global infrastructure. While management observed "zero impact on BRIUMVI" from the ZUNOVO product, Roche's scale and established relationships could pressure BRIUMVI's market share gains.

Novartis (NVS)'s Kesimpta, with $2.3 billion in nine-month 2025 sales and nearly 50% growth, dominates the subcutaneous segment TGTX aims to enter. If Kesimpta entrenches further or improves its dosing regimen, it could limit subcu BRIUMVI's addressable market. The subcutaneous market's 35% to 40% share of new starts is growing, but TGTX will be a late entrant without established self-administration brand recognition.

Regulatory and Manufacturing Risks

The 100% tariff on imported pharmaceuticals effective October 1, 2025, directly threatens BRIUMVI's cost structure, as the drug is manufactured in South Korea. While management stated the North Carolina facility is "several years" away from commercial scale and was established for backup manufacturing, not tariff avoidance, the tariff could materially impact gross margins unless exempted through negotiation or domestic production accelerates.

Single-source supplier risk for starting materials, API, and drug product could delay development or commercialization if manufacturing disruptions occur. The company's $202 million in purchase commitments through 2027 reflects this dependency, and any quality issues could interrupt the commercial supply of BRIUMVI.

Market Opportunity and Pricing Risks

The precise incidence and prevalence of RMS patient populations remain uncertain, and if market opportunities prove smaller than estimated or if approvals are limited to narrower patient definitions, revenue and profitability could fall short. Healthcare cost containment trends, including Inflation Reduction Act price negotiations and biosimilar competition, could pressure BRIUMVI's pricing power, which management has positioned as cost-effective relative to competitors.

Post-marketing side effects could emerge after approval, leading to significant negative consequences. While six-year data shows no new safety signals, the relatively small patient exposure compared to Ocrevus's massive installed base means rare events may not yet be detected.

Valuation Context

Trading at $30.76 per share, TG Therapeutics carries a market capitalization of $4.88 billion and enterprise value of $5.01 billion. The stock trades at 11.10 times trailing earnings, substantially below the medical sector average of approximately 38.59 and the broader market average of 39.05, suggesting the market has not yet assigned a typical biotech growth premium despite the 93% revenue growth rate.

On a revenue basis, the EV/Revenue multiple of 9.41 sits between slower-growing large pharma (Roche at 4.90, Novartis at 4.50) and earlier-stage biotech companies, reflecting the market's recognition of BRIUMVI's commercial validation but caution about single-product risk. The company's 85.34% gross margin and 18.16% operating margin demonstrate profitability at a scale where many peers remain unprofitable, while the 111.96% return on equity indicates efficient capital deployment.

Balance sheet strength provides strategic optionality: $178.3 million in cash and investments against minimal debt (debt-to-equity of 0.42) and a current ratio of 3.83. The absence of a dividend (payout ratio 0.00%) and the active share repurchase program show management prioritizing growth investment and capital return over income distribution.

Conclusion

TG Therapeutics stands at an inflection point where BRIUMVI's commercial success has transformed the company from a speculative biotech into a profitable, self-funding enterprise growing at 93% annually. The glycoengineered antibody's one-hour infusion profile and six-year durability data have enabled it to capture nearly one in three new IV anti-CD20 patients, demonstrating clear product-market fit in the $10 billion MS market. Management's disciplined capital allocation—returning $100 million to shareholders while maintaining expense guidance—signals confidence in the core business.

The investment thesis's success over the next 18 months depends on two critical variables: the subcutaneous program's ability to capture the 35% to 40% of patients preferring self-administration, and the company's capacity to execute on timeline targets while fending off competitive pressure from Roche's pipeline and Novartis' entrenched Kesimpta position. The 100% tariff on imported drugs adds a macro risk that could compress margins unless mitigated through domestic manufacturing or trade negotiations.

Trading at 11.10 times earnings with a clear path to multibillion-dollar peak sales, TGTX appears undervalued relative to its growth trajectory if pipeline execution succeeds. However, the single-product concentration means any stumble—whether clinical, regulatory, or competitive—would likely trigger severe multiple compression. For investors, the risk/reward is asymmetric: successful subcutaneous launch could nearly double the addressable market and justify a premium valuation, while delays or competitive erosion could leave the company vulnerable with limited diversification. The next 18 months will determine whether TGTX evolves into a diversified immunology leader or remains a successful but concentrated single-product story.