TG Therapeutics Eyes $1B Run Rate as BRIUMVI Gains MS Market Share

Key Points

• BRIUMVI has captured more than one-third of the intravenous anti-CD20 market for relapsing multiple sclerosis, with TG Therapeutics targeting an annualized revenue run rate above $1 billion exiting the fourth quarter.
• TG Therapeutics expects growth from improving gross-to-net trends, rising treatment-naive patient use and a potential simplified one-visit IV dosing regimen, with a supplemental biologics license application expected imminently.
• The company is developing a subcutaneous BRIUMVI formulation to reach self-injecting patients, with pivotal Phase 3 data expected by year-end or early next year and potential approval targeted for 2028.

TG Therapeutics NASDAQ: TGTX Chairman, President and Chief Executive Officer Mike Weiss said the company’s multiple sclerosis therapy, BRIUMVI, has captured more than one-third of the intravenous anti-CD20 market and continues to gain share as it approaches its fourth full year on the market.

Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Weiss described the relapsing multiple sclerosis, or RMS, treatment market as one in which roughly 40,000 patients annually begin anti-CD20 therapy. He said approximately 65% to 70% of those patients choose an IV option, while about 30% to 35% choose a self-administered subcutaneous treatment.

BRIUMVI currently competes in the IV market, including against another IV product and a physician-administered subcutaneous option, Weiss said. TG Therapeutics does not yet participate in the self-injection segment, but the company is developing a subcutaneous formulation of BRIUMVI.

Revenue Drivers and Second-Half Trends

Weiss said the company’s projections for BRIUMVI are primarily driven by new patient starts, treatment persistence and gross-to-net changes. Persistence becomes an increasingly important variable as the installed patient base grows, he said, noting that TG Therapeutics estimates the median time on a competing CD20 product is about five years.

The company had updated its guidance to $890 million to $905 million, according to H.C. Wainwright analyst Emily Bodnar. Weiss said gross-to-net dynamics can fluctuate quarter to quarter and may have a material effect as repeat business represents a larger portion of sales.

For the second half of the year, Weiss said improving gross-to-net trends could provide a benefit. However, he noted that the third quarter generally has the smallest portion of the annual pool of patients starting new therapies. TG Therapeutics is targeting an exit fourth-quarter run rate exceeding $1 billion, which Weiss called an important milestone for the company.

Patient Mix and Simplified IV Dosing

Weiss said the proportion of treatment-naive patients starting BRIUMVI has increased since launch. At the same time, the percentage of patients switching from other CD20 therapies has remained consistent.

Patients beginning BRIUMVI now fall into three nearly equal groups, according to Weiss: treatment-naive patients, patients switching from therapies outside the CD20 class, and patients transferring from another CD20 product. He said the growth in treatment-naive use has outpaced transfers from other therapies, while CD20 switching has remained “rock solid” quarter after quarter.

He also discussed the company’s enhanced dosing study, which evaluated combining the first two BRIUMVI doses into a single administration. Weiss said feedback from clinicians and medical practices indicated that a one-visit approach could simplify patient scheduling and improve the treatment initiation process.

TG Therapeutics is preparing a supplemental biologics license application related to the simplified dosing approach. Weiss said the filing should be “imminent” and that the company expects the dosing change to support growth in 2027.

Subcutaneous BRIUMVI Program

Weiss said TG Therapeutics views subcutaneous BRIUMVI as a meaningful market-expansion opportunity because it would allow the company to address the roughly 30% to 35% of patients who choose self-injection rather than IV treatment.

The company recently reported Phase 1 data from approximately 90 participants, including multiple sclerosis and myasthenia gravis patients. Weiss said the study demonstrated bioavailability of slightly more than 60%, with a relatively tight confidence interval.

The Phase 3 program is evaluating dosing every other month and every three months. Based on Phase 1 bioavailability data, Weiss said the company’s modeled result for quarterly dosing was approximately 1.23 relative to IV exposure, within the FDA’s stated 0.8-to-1.25 standard for the measure he described.

He said TG Therapeutics expects pivotal Phase 3 data for subcutaneous BRIUMVI by the end of the year or early next year. The company is targeting a potential approval in 2028. Weiss characterized an auto-injector administered in approximately 10 seconds every three months as an attractive potential profile for patients.

Pipeline and Upcoming Catalysts

Beyond RMS, TG Therapeutics is studying BRIUMVI in myasthenia gravis and is pursuing a treatment-resistant schizophrenia program. For myasthenia gravis, Weiss described a potential treatment approach using an FcRn therapy to achieve symptom relief, followed by BRIUMVI to help maintain remission. He said that approach could potentially have relevance in other diseases.

In schizophrenia, Weiss said there is evidence pointing toward a neuroinflammatory component in the disease, though he noted there is not yet established proof for CD20-targeted treatment. He cited a small group of patients treated with Rituxan that had positive results.

Over the next 12 to 18 months, Weiss identified several expected milestones: the supplemental BLA for simplified IV dosing, azer-cel data at ECTRIMS, pivotal subcutaneous Phase 3 data, potential schizophrenia-related information in 2027, and an anticipated 2028 approval timeline for subcutaneous BRIUMVI.

About TG Therapeutics (NASDAQ:TGTX)

TG Therapeutics, Inc is a commercial-stage biopharmaceutical company focused on developing and delivering treatments for B-cell diseases and autoimmune disorders. The company's research and development programs are centered on therapies that target B cells, which play an important role in several immune-mediated conditions.

TG Therapeutics' principal product is BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody approved by the U.S. Food and Drug Administration for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis.

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