Viridian Therapeutics (NasdaqCM:VRDN) FY Conference Transcript

Summary of Viridian Therapeutics FY Conference Call Company Overview - Company: Viridian Therapeutics (NasdaqCM: VRDN) - Focus: Development of treatments for thyroid eye disease and other conditions Key Points Industry and Market Context - The company operates in a market valued at $2 billion in the U.S. for thyroid eye disease treatments [4] - The company is preparing for significant growth in 2026 with new product launches and regulatory filings [1] Product Development and Regulatory Progress - The company has submitted a Breakthrough Therapy designation for its treatment program, highlighting rapid treatment effects observed after just three weeks and one infusion [2] - The treatment regimen involves five infusions over three months, using 70% less drug compared to currently approved products [2] - Upcoming top-line data for active and chronic populations using a subcutaneous program is expected in Q1 and Q2 of the following year [3] Clinical Trials and Efficacy - The REVEAL-1 study targets active patients, while REVEAL-2 focuses on chronic patients, both designed similarly to previous successful trials [9] - The company aims for a 50%-70% placebo-adjusted proptosis response, matching the efficacy levels of existing treatments like Tepezza [13] - The design of the studies aims to minimize placebo drift, with consistent operational teams across trials [15] Safety and Patient Impact - The safety profile of the treatment is well understood, with expectations of mild and transient side effects [21] - The urgency for treatment is emphasized, particularly for the predominantly female patient population in their forties and fifties suffering from debilitating symptoms [22] Commercial Strategy and Expansion - The company is looking to expand geographically, with plans to file for Marketing Authorization Application (MAA) in Europe in Q1 of the coming year [4] - A partnership in Japan has been established, leveraging existing pricing strategies from approved products [5] Financial Position and Future Outlook - The company recently completed a royalty deal and an equity raise, positioning itself to reach profitability and break-even [26] - Current cash reserves are reported to be just shy of $900 million, providing a strong foundation for executing its portfolio [26] Conclusion - Viridian Therapeutics is poised for significant advancements in the treatment of thyroid eye disease, with a robust pipeline, strategic partnerships, and a solid financial position to support its growth initiatives [27]