Core Insights - Nxera Pharma reported a disciplined execution and strategic progress in 2025, focusing on building a resilient biopharmaceutical business with a growing commercial presence in Japan and a maturing pipeline [2][3] Operational Highlights - PIVLAZ® sales in Japan increased, establishing it as the standard of care for preventing cerebral vasospasm, with market share rising from 69% in 2024 to 74% in 2025 [6] - Q4 2025 net sales for PIVLAZ® reached JPY 4,545 million (US$30.4 million), while FY 2025 net sales totaled JPY 13,511 million (US$90.3 million), reflecting a 6.8% growth compared to FY 2024 [6][17] - QUVIVIQ™ achieved FY 2025 net sales of JPY 4,327 million (US$28.9 million), marking a significant 223.9% growth from FY 2024 [7][17] - The company regained full rights to its GPR52 agonist program and plans to explore strategic opportunities for this asset [9] Financial Performance - Total revenue for FY 2025 was JPY 29,615 million (US$197.9 million), an increase of JPY 780 million (US$5.2 million) from the previous year [17] - R&D expenses rose to JPY 14,466 million (US$96.7 million), reflecting increased investment in clinical-stage pipelines and the obesity and metabolic disease area [17] - Operating loss for FY 2025 was JPY 8,462 million (US$56.5 million), compared to a loss of JPY 5,423 million (US$35.9 million) in the prior year [17] - Net loss totaled JPY 12,530 million (US$83.7 million), up from a loss of JPY 4,838 million (US$32.0 million) in the previous year [23] Strategic Initiatives - Nxera implemented a focused restructuring to enhance its path to profitability, concentrating resources on high-potential programs and reducing operating expenses [8] - The establishment of a Metabolic Advisory Council aims to provide guidance as Nxera advances its pipeline targeting obesity and metabolic disorders [11] - The company plans to submit a marketing authorization application for daridorexant in South Korea in Q1 2026, with approval expected in Q1 2027 [10]

Core Viewpoint - Nxera Pharma has entered an exclusive licensing agreement with Santhera Pharmaceuticals for the development, manufacturing, and commercialization of vamorolone for Duchenne Muscular Dystrophy (DMD) in Japan, South Korea, Australia, and New Zealand [1][5]. Group 1: Licensing Agreement Details - Nxera will be responsible for obtaining regulatory approval for vamorolone in the licensed territories, including conducting necessary clinical trials and leading commercialization and manufacturing activities [3]. - The agreement includes an upfront payment of USD 40 million to Santhera, consisting of USD 30 million in cash and USD 10 million as a strategic equity investment [6]. - Santhera is eligible for additional sales and regulatory milestone payments of up to USD 165 million, along with tiered royalties starting in the low teens on net sales of vamorolone in the licensed territories [6]. Group 2: Product and Market Potential - Vamorolone is positioned as a late-stage development candidate that addresses significant unmet needs for DMD patients in Japan and the Asia-Pacific region [2]. - The product is already approved and marketed as AGAMREE® in the US, EU, UK, and China, highlighting its established presence in the market [1][8]. - Vamorolone's differentiated safety and efficacy profile has the potential to change the standard of care for DMD by allowing early use, full dosing, and long-term treatment, addressing limitations of existing steroid therapies [4][8]. Group 3: Company Strategy and Vision - The transaction aligns with Nxera's mission to bring innovative medicines to patients in Japan and the APAC region, supporting its 2030 vision to build a high-growth, highly profitable biopharma company [5][8]. - Nxera's team has significant prior development and manufacturing experience with vamorolone, enhancing its capability to commercialize the product effectively in the targeted markets [3][5].