TG Therapeutics (TGTX) gave an upbeat update on its multiple sclerosis drug BRIUMVI at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Wednesday, with Chairman and CEO Mike Weiss saying the intravenous franchise is approaching a $1 billion annual run rate before the end of 2024.
Weiss projected sequential growth for the third quarter and faster momentum heading into the fourth. Wall Street estimates for 2027 sales sit at $1.2 billion.
The company is also advancing a subcutaneous formulation. Phase III data are expected in late 2024 or early 2025, and a simplified onboarding regimen from the ENHANCE trial could reach the market in 2027. Nationwide direct-to-consumer marketing is slated for the second half of 2026, following pilot campaigns in five to ten markets using linear TV, digital and online advertising.
Weiss pushed back against current street peak-sales assumptions. He described estimates of $2 billion for the IV franchise as "pretty low" and said projections of $1 billion to $2 billion for the subQ formulation were similarly undervalued. "I thought the subQ opportunity was potentially more than double [the IV business]," Weiss said.
If Neuraxpharm opts in for the subQ version within a 90-day decision window, the arrangement calls for a $40 million to $50 million upfront payment plus proportional sharing of development costs.
BRIUMVI is priced at a 20% to 25% discount to Roche's OCREVUS. Weiss noted that a biosimilar ocrelizumab would likely need to enter at roughly a 50% discount to materially affect BRIUMVI pricing, while typical biosimilars price in the 20% to 25% range off the innovator drug.
On the competitive front, Weiss acknowledged that Roche has publicly stated a goal of transitioning patients off IV OCREVUS to its own subcutaneous offering and then to an at-home product. TG Therapeutics views that strategy as internal cannibalization rather than market expansion, leaving room for infusion centers and BRIUMVI to capture share in the IV segment.
Weiss defended the company's continued commitment to the IV business despite the subQ push. "We are completely committed long-term to the IV business," he said.
Patent protection for the asset is robust, Weiss said. The protein-sequence patent expires in 2035, the composition-of-matter patent runs through 2042, and a pending application could extend protection to 2045 if granted. "When you have an antibody, the process is the product. You can't make BRIUMVI unless you go through the 2042 patent. I think it's pretty darn strong," he said.
BRIUMVI's design amplifies antibody-dependent cellular cytotoxicity, giving it an edge in deep tissue B-cell killing, whereas Sanofi's KESIMPTA was built to enhance complement-dependent cytotoxicity. Competitors discussed at the session included Roche, Novartis and Sanofi.
Beyond multiple sclerosis, TG Therapeutics is exploring BRIUMVI in schizophrenia, where a Phase II open-label study is testing the drug for treatment-resistant cases based on an immune-mediated inflammation hypothesis. The company is also evaluating BRIUMVI as a maintenance therapy for myasthenia gravis following FcRn induction treatments such as VYVGART, aiming to avoid symptom-return cycles. Additional pipeline areas mentioned include major depressive disorder, epilepsy and CAR T cell work spanning MS, MG and CIDP.
