Financial Data and Key Metrics Changes - The company reported net revenue of $239.5 million for Q3 2025, representing a 29% year-over-year growth [5][20] - Cash generation was robust at $106 million, bringing the total cash and cash equivalents to $778 million as of September 30, 2025 [5][22] - Non-GAAP adjusted net income for Q3 2025 was $63.5 million, or $1.8 per diluted share, compared to $57.3 million, or $0.99 per diluted share in the prior year quarter [21][22] Business Line Data and Key Metrics Changes - The WCAGX product line achieved an average of 8,100 patients by the end of Q3, with a record increase of approximately 500 new patients added during the quarter [9][10] - The company raised its full-year revenue guidance from $820 million to a range of $845 million to $865 million, reflecting strong demand for WCAGX [12][23] Market Data and Key Metrics Changes - The company noted that WCAGX is rapidly approaching blockbuster status, with expectations of exceeding $1 billion in annual revenue from narcolepsy alone [6][25] - The company has secured important new payer coverage wins, which continue to expand its already broad payer coverage [11] Company Strategy and Development Direction - The company aims to become a leading patient-focused CNS company, delivering innovative treatments for unmet medical needs [7] - The late-stage pipeline includes multiple catalysts, with plans to initiate two Phase III trials for Pitolacin HD by the end of 2025 [6][14] - The company is focused on strategic business development to enhance its pipeline and product portfolio [46][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth trajectory, driven by strong fundamentals and execution across the organization [12][113] - The company anticipates ongoing investments in R&D to advance its late-stage pipeline, with five Phase III registrational programs expected by year-end [23][24] Other Important Information - The company has filed utility patents for both Pitolacin GR and HD, securing potential exclusivity until 2044 [16][76] - The IND for Pitolacin HD has been submitted to the FDA, with target PDUFA dates set for 2028 [14][16] Q&A Session Summary Question: Can you elaborate on the trajectory of WCAGX evolving into 2026? - Management noted that the performance is driven fundamentally by patient adds, with a record increase of 500 patients in Q3, and strong fundamentals are expected to carry forward into Q4 and 2026 [30][33] Question: What were the GI AEs seen with the GR formulation? - No new safety or tolerability issues were observed with the Pitolacin GR formulation, and all patients were able to initiate treatment at the therapeutic dose without issues [35][36] Question: What are the current thoughts on business development and M&A? - The company remains focused on strategic business development, actively evaluating several opportunities to enhance its pipeline [46][67] Question: How is new patient growth coming from? - New patient growth is primarily from deeper penetration within existing prescribers, with a stable breakdown of NT1 and NT2 patients [120][97] Question: Can you discuss the EPX-100 epilepsy program? - The company is excited to share efficacy data at the upcoming American Epilepsy Society meeting and continues to recruit patients for ongoing studies [87][88]