Viridian Therapeutics (VRDN) investor relations material

Key program updates and milestones

• Lead IV program for thyroid eye disease (TED) has a June 30 PDUFA date, with launch readiness nearly complete and positive FDA interactions to date.

• Two phase III readouts for subcutaneous TED program expected in Q1 and Q2, targeting both active and chronic forms of the disease.

• Preclinical TSHR antibody program for TED and Graves’ disease to file IND in Q4, aiming to expand pipeline and market reach.

• FcRn portfolio advancing with first-in-human studies and healthy volunteer data expected in the second half of the year.

• European regulatory submission completed in January, with commercial strategy to be determined based on pricing and market dynamics.

Commercial strategy and market positioning

• Launch preparations include hiring field force, building market access, patient services, and medical affairs teams, all ahead of schedule.

• Pricing strategy guided by payer feedback, aiming for parity with current market leader Tepezza, considering total regimen cost.

• Initial commercial focus on 2,000 core prescribers already familiar with IGF-1R therapies, leveraging existing education and infrastructure.

• Subcutaneous program expected to expand market by improving access and convenience, with projections of 70% market share for subQ in a mature market.

• European launch strategy remains flexible, with options to build infrastructure or use distributors, benefiting from competitor experience.

Clinical differentiation and competitive landscape

• IV and subQ programs use the same antibody, with subQ offering half-life extension and at-home administration via autoinjector.

• Efficacy bar for subQ set at 50%-70% proptosis responder rate, matching or exceeding current standards, with safety profile expected to be consistent with IGF-1R class.

• SubQ delivery anticipated to attract new patient segments and prescribers, especially those less able to access infusion centers.

• Competitive landscape has thinned, with several rival programs discontinued; Amgen’s subQ offering seen as less convenient due to infusion pump format.

• High patient demand and robust trial enrollment, especially in the US, support strong launch prospects.