Financial Data and Key Metrics Changes - Total revenues for Q3 2025 increased by $0.5 million, or 4% year over year, to $12.8 million, excluding the impact of one-time recognition of deferred revenue in Q3 2024 [19][25] - Net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to a net loss of $11.5 million, or $0.13 per share in Q3 2024 [24][25] - Non-GAAP adjusted EBITDA loss was $8.6 million in Q3 2025, compared to a loss of $6.6 million in Q3 2024 [25] Business Line Data and Key Metrics Changes - Manufacturer and supply revenue increased to $11.5 million in Q3 2025 from $10.7 million in Q3 2024, primarily due to increases in Sympazan and Suboxone revenues [19] - Research and development expenses decreased to $4.5 million in Q3 2025 from $5.3 million in Q3 2024, mainly due to lower clinical trial costs associated with the Anafilm program [20][21] - Selling, general, and administrative expenses increased to $15.3 million in Q3 2025 from $12.1 million in Q3 2024, driven by higher pre-commercial spending and legal fees [22][23] Market Data and Key Metrics Changes - The market for epinephrine products grew by almost 9% last quarter, with a significant portion of growth coming from autoinjectors [29][56] - 95% of prescriptions in the epinephrine market are for autoinjectors, indicating a strong focus for the company’s strategy [41][56] Company Strategy and Development Direction - The company is focused on launching Anafilm, the first oral medication for severe allergic reactions, with a scheduled FDA action date of January 31, 2026 [7][8] - Plans to exploit the science behind the Adrenoverse platform are underway, with a focus on advancing R&D efforts in 2026 [10][12] - The company aims to establish partnerships for international distribution of Anafilm, with filings anticipated in Canada and Europe in 2026 [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA review process and the readiness for a potential launch of Anafilm in Q1 2026 [10][40] - The company is well-positioned financially to support the launch of Anafilm, having completed significant equity and commercial launch financing [17][25] - Management highlighted the importance of patient access and pricing strategy, emphasizing a patient-first approach [33][34] Other Important Information - The company has made leadership changes to better support the launch of Anafilm and the development of the Adrenoverse platform [11] - The company’s manufacturing operations remain stable, with a focus on maintaining supply chain reliability [18] Q&A Session Summary Question: Any new comments on your competitor's citizens' petition? - Management believes the petition indicates competitor concern about the market entry of Anafilm and has seen no impact on the FDA review process [30][32] Question: How are you thinking about pricing relative to the nasal spray and the generic EpiPen? - The company plans to price Anafilm responsibly with a patient-first approach, ensuring broad access through various programs [33][34] Question: How do you think about the optimal timing for partnerships outside the U.S.? - The company is actively engaging in partnership discussions and believes that closer proximity to regulatory approvals will enhance product value [36] Question: What are the key aspects of product profiles that physicians focus on? - Physicians prioritize efficacy, safety, and the convenience of administration, with a strong interest in the product's pharmacokinetics [59] Question: Can you discuss the importance of the new patents for Anafilm? - The new patents are crucial for strengthening the overall patent portfolio and protecting the product's market position [62]