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.

Summary of the Conference Call for Dize Pharmaceutical Company Overview - Dize Pharmaceutical was established in 2017 by Guotou Innovation and a subsidiary of AstraZeneca, and it went public on the STAR Market in 2021. The company focuses on the research and development of small molecule drugs, with a core team that has extensive international experience from AstraZeneca China [9][3]. Key Products and Market Performance Shuwotini - Shuwotini is the world's first small molecule drug targeting EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC), already launched in China and included in medical insurance. Expected sales in China are close to 400 million RMB in 2024, projected to reach 700-800 million RMB in 2025. In the US, it is expected to be priced around $200,000 [2][4]. - The drug has rapidly become the top recommended product in treatment guidelines for second-line therapy, with an anticipated penetration rate of over 30% in second-line and around 30% in first-line treatments in China. The US market penetration is expected to reach 40% [16][17]. - The peak sales potential for Shuwotini in China is estimated at 2 billion RMB, while in the overseas market, it could reach $900 million, contributing approximately $500 million from the US market [17][22]. Gresitini - Gresitini is approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) and has entered the Chinese medical insurance system. The phase III clinical trial for first-line PTCL is expected to complete enrollment in 2025, with a potential US launch in the first half of 2026 [6][18]. - The peak sales potential for Gresitini in China is estimated at 1 billion RMB, with overseas sales potential reaching $600 million [22]. 8,586 - 8,586 is a dual-target BTK inhibitor with strong blood-brain barrier penetration, currently undergoing registration clinical trials for relapsed/refractory mantle cell lymphoma (MCL) and has potential applications in DLBCL. It aims to address resistance issues associated with BTK inhibitors [7][19]. - The domestic peak sales potential for 8,586 is estimated at 2 billion RMB, while overseas it could reach $1.5 billion [20][22]. 6,008 - 6,008 is a next-generation EGFR TKI effective against C797S mutations and has blood-brain barrier penetration capabilities. It is expected to be presented at the 2025 ASCO conference, with preliminary data anticipated by the end of the year [7][21]. - The domestic peak sales potential for 6,008 is estimated at 2 billion RMB, with overseas potential reaching $1.5 billion [21][22]. Financial Projections - The total peak sales potential for the four main products in the domestic market is projected to reach 6 billion RMB, corresponding to a market valuation of 180 billion to 200 billion RMB. In the overseas market, the combined sales potential is estimated at $3.5 billion, leading to a total target market valuation of approximately 40 billion RMB [8][22]. Competitive Landscape - Shuwotini's competitive advantages include its high safety profile and significant efficacy compared to traditional therapies, which have lower objective response rates (ORR) and progression-free survival (PFS) [13][15]. - Current competitors include companies like Ailis and Ravent, with their respective drugs showing varying efficacy and safety profiles [14]. Additional Insights - The core team of Dize Pharmaceutical has established a robust small molecule drug development platform, particularly excelling in central nervous system research, which accelerates drug development processes [9][4]. - The company aims to achieve profitability by 2027 following a recent financing round of 1.85 billion RMB, which has alleviated some negative impacts from previous share reductions [3].