Viridian Therapeutics (VRDN) investor relations material

Regulatory and clinical milestones

• Anticipates commercial approval with a PDUFA date set for June 30, supported by consistent and positive regulatory interactions.

• Positive top-line results from subcutaneous REVEAL-1 and REVEAL-2 studies, advancing Q4 and Q8 weekly dosing with BLA submission targeted for Q1 2027.

• TSHR program guided to IND submission in Q4, expanding applicability to both thyroid eye disease and Graves’ disease.

• FcRn portfolio progressing, with first-in-human data for VRDN-006 showing expected IgG suppression and albumin sparing; VRDN-008 phase I data expected in the second half of the year.

• Plans to disclose indication strategies and next development steps for FcRn programs later this year.

Commercial launch readiness and strategy

• Sales force of just under 100 is fully hired and trained, with operational readiness across supply chain, patient support, and market access.

• Launch strategy targets 2,000 core prescribers identified through claims analysis, focusing on those who primarily prescribe TEPEZZA.

• Medical affairs team and patient support services are established, with the ability to accept patient enrollment forms immediately post-approval.

• Direct-to-consumer advertising will be limited, leveraging social media and benefiting from existing market education by competitors.

• Confident in resource allocation, with sales force size comparable to competitors and a focus on physician and patient education.

Product differentiation and market positioning

• Veli IV offers rapid onset, significant diplopia improvement, and a shorter 12-week treatment course, with each infusion lasting 30–45 minutes.

• Anticipates label differentiation with data in both active and chronic thyroid eye disease, potentially being the first with such a broad indication.

• Subcutaneous options (Q4 and Q8 weekly) provide flexibility for patient needs, with auto-injector pens designed for at-home administration.

• Chronic TED population is under-penetrated; subcutaneous formulations expected to unlock further market potential.

• Market research indicates strong prescriber interest in new options, especially given the ease of use and differentiated clinical profile.