Financial Data and Key Metrics Changes - For fiscal year 2025, net revenue was $66.4 million, a slight increase from $65.2 million in the previous year [27] - Adjusted EBITDA for the year was $9.2 million, marking the third consecutive year of positive adjusted EBITDA, compared to $10.8 million in the prior year [33] - The net loss for the year was $13.6 million, an improvement from a net loss of $15.8 million in the previous year [32] Business Line Data and Key Metrics Changes - ADHD portfolio net revenue was $57.6 million, slightly down from $57.8 million in the prior year, attributed to a decrease in the number of scripts written [27] - Pediatric portfolio revenue increased to $8.8 million from $7.3 million, reflecting a successful return-to-growth plan [29] - Gross margin decreased to 69% from 75% in the previous year, primarily due to increased cost of sales in ADHD inventory [29] Market Data and Key Metrics Changes - The U.S. market for major depressive disorder (MDD) is over $22 billion, with more than 340 million prescriptions written annually [9] - SSRIs and SNRIs account for over 60% of all antidepressants prescribed, with approximately 220 million TRXs [9] Company Strategy and Development Direction - The company is focusing on the upcoming launch of Exua, a novel treatment for MDD, which is expected to transform its business [4] - Aytu BioPharma plans to leverage its psychiatry-focused sales force and proprietary Aytu RxConnect patient access platform for product acquisitions aligned with its focus [5] - The company aims to minimize coverage barriers and enhance patient access through selective payer contracting [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the Exua launch, highlighting strong physician interest and potential market need for targeted therapies [11][41] - The company anticipates that the Exua opportunity will significantly enhance its growth trajectory, positioning it as a leading CNS-focused company [43] Other Important Information - The company has successfully launched an authorized generic of Adzenys, which is expected to help maintain market share despite potential competition from Teva [20] - Aytu BioPharma has restructured its operations, resulting in a new cost structure that projects a break-even level of approximately $52.6 million annually [31] Q&A Session Summary Question: Will there be a national sales meeting for Exua? - Yes, the company plans to load in by the end of 2025 and have a sales force meeting followed by a full launch in the first calendar quarter [46] Question: Will promotional materials be pre-cleared? - The company does not plan to pre-clear promotional materials but will follow the traditional submission process [47] Question: What is the approach to engaging with payers? - The company will engage with payers on a case-by-case basis, being selective to ensure favorable contracting without undermining margins [50][51] Question: What are the expectations for ADHD and pediatric franchises? - The ADHD portfolio is expected to maintain some level of stickiness, while the pediatric portfolio will cover general and administrative expenses going forward [58] Question: What is the medical affairs strategy for Exua? - The company plans to engage in extensive medical education and presence at medical conferences, focusing on key opinion leaders [60]

Core Viewpoint - The launch of "Liyoujia," a generic version of methylphenidate extended-release tablets by Lifan Pharmaceutical, breaks the monopoly of Johnson & Johnson's "Zhuanzhuda" in the ADHD treatment market in China, addressing the supply issues faced by patients [1][8]. Group 1: Market Demand and Supply - Approximately 20 million children and adolescents in China suffer from ADHD, with a prevalence rate of 6.26% among children, but only about 10% seek treatment [3][4]. - The sales of methylphenidate extended-release tablets reached approximately 350 million yuan in 2023 and are projected to grow to about 430 million yuan in the first three quarters of 2024 [4]. - The original drug "Zhuanzhuda" frequently experiences supply shortages due to strict regulations and high raw material costs, leading to patient anxiety regarding medication availability [1][5][6]. Group 2: Product Comparison and Pricing - "Liyoujia" is priced approximately 20% lower than the original drug, with the original priced at about 19 yuan per tablet and "Liyoujia" at approximately 15.3 yuan per tablet [8][11]. - The production and sales of methylphenidate extended-release tablets require approval from the National Medical Products Administration, with plans for production volume to be reported in October [8][10]. Group 3: Regulatory Environment and Market Position - As a first-class psychotropic drug, "Zhuanzhuda" is subject to strict regulations, and its global demand has been increasing, which exceeds the production capacity of Johnson & Johnson [5][11]. - "Liyoujia" is not subject to centralized procurement due to its classification as a psychotropic drug, which is expected to stabilize its pricing in the market [11].

Summary of Supernus Pharmaceuticals (SUPN) Conference Call Company Overview - Supernus Pharmaceuticals is a CNS-focused biopharmaceutical company with approximately eight products on the market, including legacy products and significant growth drivers [3][4] - The company reported profitable revenues around $600 million, despite the loss of exclusivity on flagship products [5] Key Products and Financials - **KELBRII**: A novel ADHD treatment launched in May 2021, currently generating a run rate of approximately $260 million. The product has significant growth potential with a large market of 100 million prescriptions annually [4][7][8] - **ONAPCO**: A recently launched infusion device for Parkinson's, with over 200 prescribers and 500 patient enrollment forms submitted within a month of launch. The peak sales potential is estimated between $200 million to $300 million [27][31][34] - Revenue expectations for 2025 are projected between $600 million and $630 million, with 2025 potentially being a trough year due to the full-year impact of generic competition for Oxtellar XR [6][7] Growth Drivers - The growth of KELBRII, GOCOVRI, and ONAPCO are expected to offset revenue losses from other products [6] - The company anticipates continued volume growth in prescriptions, with a historical growth rate of over 20% for KELBRII [10][11] Market Dynamics and Competition - The ADHD market is characterized by competition, but the company believes that competition can be beneficial for market growth [25][26] - Potential competitors for KELBRII include Osuka and Axsome, but the company remains optimistic about its long-term growth trajectory [22][23] Pipeline Developments - **SPN-820**: A novel mTORC inhibitor for major depressive disorder (MDD) is set to enter a Phase 2b study, with hopes of demonstrating a clinically meaningful reduction in depression scores [42][49] - **SPN-817**: An acetylcholinesterase inhibitor for epilepsy, with Phase 2 data expected by the end of 2027. The drug shows promise in reducing seizures while potentially improving cognitive function [57][61] Business Development Strategy - The company is actively pursuing business development opportunities, focusing on commercial assets and products that can be launched between 2026 and 2030 [68][69] - Supernus has a clean balance sheet with zero debt, providing financial flexibility for potential acquisitions [69] Conclusion - Supernus Pharmaceuticals is positioned for growth with a strong product portfolio and pipeline, despite facing challenges from generic competition and market dynamics. The company is committed to exploring business development opportunities to enhance its product offerings and maintain its competitive edge in the CNS market [70]