Viridian Therapeutics (VRDN) investor relations material

Pipeline and clinical progress

• Advancing drugs for thyroid eye disease (TED) and other autoimmune conditions, with a PDUFA date for the first commercial product set for June 30, 2026.

• Positive phase III results for IV veligrotug and subcutaneous (subQ) programs, with BLA submission for subQ planned in Q1 2027.

• TSHR program announced for TED and Graves' disease; FcRn portfolio in first-in-human studies with more data expected in the second half of the year.

• FcRn 006 program completed phase I with promising IgG reductions; 008 program aims for best-in-class half-life extension, with healthy volunteer data expected soon.

• Targeting 60%-70% IgG reduction as a benchmark for FcRn programs, aligning with industry standards.

Commercial launch and market strategy

• Operationally prepared for immediate launch upon approval, with field, medical affairs, and patient support teams in place and supply chain ready.

• Payer feedback indicates parity coverage is likely if pricing matches current therapies, with 85% of covered lives accessible.

• Initial quarters post-approval will focus on patient enrollment and prescriber engagement, with revenue ramping up as prior authorizations are processed.

• Revenue growth expected to accelerate after the first two quarters, with a full ramp anticipated in 2027.

Market opportunity and product differentiation

• TED market is under-penetrated, with only 6,000–7,000 patients treated annually out of a 40,000 incident population; current therapy has single-digit penetration.

• Veligrotug IV and subQ offer rapid onset, robust efficacy in proptosis and diplopia, and shorter treatment duration (12 weeks vs. 21 weeks for current therapy).

• SubQ ELE auto-injector demonstrated IV-like efficacy in phase III, with as few as three doses and strong physician and patient interest.

• Chronic TED market seen as a major expansion opportunity, with subQ delivery expected to attract patients and prescribers who avoid IV therapies.

• Pricing for subQ likely to follow parity with IV on a per-course basis, with both products positioned for broad access.