Summary of Precigen (PGEN) Conference Call - August 18, 2025 Company Overview - **Company**: Precigen (PGEN) - **Product**: PapSimios - **Indication**: Treatment of adults with recurrent respiratory papillomatosis (RRP) - **FDA Approval**: First and only FDA-approved therapy for RRP Key Points and Arguments FDA Approval and Significance - PapSimios received full FDA approval, eliminating the need for a confirmatory study, marking a significant milestone for the RRP community [2][4] - This approval transforms Precigen into a commercial-stage company, allowing for efficient market entry [4] Disease Overview - RRP is a rare, chronic disease caused by HPV types 6 and 11, primarily managed through surgical interventions until now [5] - Estimated patient population in the U.S. is approximately 27,000 adults [5][39] Treatment Efficacy - PapSimios targets the underlying cause of RRP, generating an immune response against HPV-infected papillomas [10] - 51% of treated patients met the primary endpoint of a complete response, defined as no surgical intervention needed for at least 12 months [10] - Durable responses observed, with 15 of 18 complete responders maintaining their response at two years [10] Commercial Strategy - PapSimios is positioned to become the standard of care for adult RRP patients due to its broad label and clinical durability [11][12] - The product is priced at $115,000 for a complete treatment course (four vials) [22][27] - Focus on integrated delivery networks (IDNs) and community hospitals, which account for over 90% of the patient population [12][13] Launch Execution - A robust commercial infrastructure is in place, with dedicated sales territories covering over 90% of ENT patient potential [13] - Preapproval information exchange has established relationships with key healthcare providers [14] - Comprehensive patient support program includes financial assistance, treatment education, and insurance navigation [17][18] Market Access and Payer Engagement - High anticipation from payers regarding the unmet need and clinical efficacy of PapSimios [31] - Discussions with payers indicate a strong likelihood of broad access for all eligible patients [31] Future Considerations - Potential for redosing to enhance immune responses in partial or non-responders, based on clinical data [32] - Ongoing monitoring of prescription metrics and market access metrics to track commercial success [16] Additional Important Content - Collaboration with the RRP Foundation to leverage patient databases for targeting and ensuring access to treatment [24][26] - The approval of PapSimios represents a historic milestone for the RRP community, providing a long-awaited therapeutic option after a century of reliance on surgical interventions [39][40]