Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics (NasdaqCM: VRDN) - **Industry**: Biotechnology, specifically focusing on treatments for thyroid eye disease and FCRN-related conditions Key Points and Arguments Thyroid Eye Disease (TED) Portfolio - Viridian is targeting the thyroid eye disease market, which is currently valued at **$2 billion annually in the U.S.** with only one approved product available [6][14] - The company has two programs in this portfolio: an intravenous (IV) program (Veligrotug) and a subcutaneous (subQ) program [6][7] - Veligrotug has completed Phase III trials and received breakthrough therapy designation, with a **BLA submitted at the end of October 2025**, aiming for a potential commercial launch in **mid-2026** [7][20] - The subQ program is designed for self-administration via an autoinjector, which could significantly expand the market by allowing patients to manage their treatment at home [8][9] - The TED portfolio has shown robust clinical enrollment, with over **500 patients enrolled in trials this year**, indicating strong commercial demand [9][10] Market Dynamics - The TED market is characterized as a "new start market," meaning Viridian does not need to switch patients from existing therapies, allowing them to capture new patients [13] - There are approximately **20,000 new cases annually in the U.S.**, with a total of **500,000 individuals affected by thyroid eye disease**, of which **200,000 have moderate to severe cases** [14] - The current approved product has low penetration in the market, providing an opportunity for Viridian to capture market share [14][23] FCRN Portfolio - Viridian has two programs in the FCRN space: VRDN-006 (a fragment approach) and VRDN-008 (half-life extended) [10][32] - The company is optimistic about the efficacy and safety profile of VRDN-006, which is expected to show IgG suppression without adverse LDL spikes [11][32] - The FCRN portfolio is positioned to address multiple indications, including Myasthenia Gravis and CIDP, with potential for further expansion into additional indications [32][33] Regulatory and Launch Preparations - The FDA interactions have been positive, with consistent communication over the years, which bodes well for the BLA review process [18][20] - The company is preparing for a commercial launch, leveraging lessons learned from the successful launch of Tepezza, which had a strong market entry despite the pandemic [21][22] - Pricing and insurance coverage have improved, with **85% of commercial plans in the U.S. now covering the current approved product**, which will benefit Viridian as they enter the market [23] Upcoming Milestones - Key upcoming milestones include: - Priority review status for the BLA expected by the end of 2025 - Top-line readouts for the subQ program in **Q1 and Q2 of 2026** - Continued development and data generation for the FCRN programs [35] Additional Important Information - The company is well-capitalized, having completed a royalty deal and equity raise in October, positioning them for profitability [12] - The autoinjector for the subQ program is commercially validated, and a bridging study is underway to support its approval [31][32] This summary encapsulates the critical insights from the conference call, highlighting Viridian Therapeutics' strategic positioning, market opportunities, and upcoming developments in their product pipeline.

Summary of Viridian Therapeutics Conference Call Company Overview - **Company**: Viridian Therapeutics - **Industry**: Biopharmaceuticals focusing on autoimmune diseases - **Key Participants**: Steve Mahoney (CEO), Tony Castianos (Chief Commercial Officer), Shan Wu (Chief Business Officer) [1][2] Core Points and Arguments Autoimmune Portfolio - Viridian is advancing an autoimmune portfolio with a focus on thyroid eye disease (TED), a market valued at approximately $2 billion in the U.S. [2] - The company has submitted a Biologics License Application (BLA) for its lead product, which has received breakthrough therapy designation from the FDA [4][2]. Market Dynamics - There is currently one competitor in the TED market, Tepezza, marketed by Amgen, which has shown a return to growth with sales of $560 million in the last quarter [10][11]. - The TED market consists of about 500,000 patients in the U.S., with 200,000 having moderate to severe forms of the disease [10][7]. Product Differentiation - Viridian's product, veligrotug, is expected to have a more favorable dosing regimen compared to Tepezza, requiring five infusions over three months versus eight infusions over five months for Tepezza [15][14]. - The onset of action for veligrotug is anticipated to be quicker, with significant proptosis response observed after just one infusion [15][16]. Clinical Data and Expectations - Phase three data from the THRIVE program indicates strong efficacy, with a proptosis response rate expected to meet or exceed the efficacy bar set by Tepezza [30][29]. - The company plans to launch with both active and chronic data in its label, which is a strategic advantage over Tepezza [17][16]. FCRN Portfolio - Viridian is also developing programs in the FCRN space, with two lead programs (006 and 008) targeting large markets projected to exceed $10 billion by 2030 [31][32]. - The company is focused on low-cost optionality in its FCRN portfolio, with ongoing studies to validate the efficacy and safety of its candidates [33][35]. Financial Position - Viridian recently announced a royalty deal with DRI, which is seen as a validation of its business model and does not encumber its lead products [37][38]. - The company expects to reach break-even and profitability, regardless of the FDA's review outcome [38][39]. Additional Insights - The TED market is characterized as a new start market, allowing for rapid adoption of new therapies without the need to switch patients from existing treatments [11][12]. - The concentration of prescribers in the TED market (approximately 2,000 core prescribers) allows for targeted commercial strategies [12][10]. - The company has engaged with over 500 key opinion leaders (KOLs) in October alone, indicating proactive market preparation [20][19]. This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Viridian Therapeutics within the biopharmaceutical industry, particularly in the treatment of autoimmune diseases.