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

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.

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.

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 T...