Arrowhead Pharmaceuticals(ARWR) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for fiscal year 2025 was $2 million, a significant improvement from a net loss of approximately $599 million in fiscal year 2024 [33] - Revenue for fiscal year 2025 totaled $829 million, driven primarily by licensing and collaboration agreements, with $697 million from Sarepta Therapeutics [33][34] - Total operating expenses for fiscal year 2025 were approximately $731 million, an increase from $605 million in fiscal 2024, primarily due to higher R&D and SG&A costs [35] Business Line Data and Key Metrics Changes - The FDA approved Redemplo, Arrowhead's first FDA-approved medicine, marking a major milestone for the company as it transitions into the commercial stage [7][8] - Redemplo is indicated for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS) and can be self-administered at home [19][24] - The One Redemplo pricing model is set at $60,000 per patient per year, aimed at providing consistent pricing across indications [11][25] Market Data and Key Metrics Changes - There are an estimated 6,500 people in the U.S. living with genetic or clinical FCS, with a prescriber base comprising specialist physicians [25] - The broader patient population at risk of acute pancreatitis includes approximately 750,000 patients with persistent chylomicronemia [10] Company Strategy and Development Direction - Arrowhead is focusing on the cardiometabolic space, with ongoing development programs for Zodasiran and ArrowDiamond PA [11][14] - The company aims to have 20 individual drug candidates in clinical trials by the end of 2025, with a balanced pipeline of wholly owned and partnered programs [41] - Arrowhead is also expanding its clinical pipeline in CNS with ArrowMapT, targeting tauopathies including Alzheimer's disease [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early feedback from healthcare professionals and payers regarding Redemplo, highlighting its significant and sustained triglyceride reduction [24] - The company anticipates that commercial sales of Redemplo will not have a substantial impact on financial statements in fiscal year 2026, but believes its cash runway is sufficient to extend into fiscal year 2028 [39] Other Important Information - Arrowhead received a $200 million upfront payment from Novartis for a licensing agreement and is eligible for up to $2 billion in future milestone payments [18][38] - The company earned a $200 million milestone payment from Sarepta following progress in the ARO-DM1 program [17][38] Q&A Session Summary Question: What is the plan to show benefit in terms of acute pancreatitis for Plozasiran? - Management indicated that shots at three and four were powered on triglyceride reduction, with the capability to pool data for evaluating pancreatitis [45] Question: Can you provide more details on the upcoming data for obesity programs? - Management confirmed that initial data from the ARO-INHBE program will be shared in early January, with more comprehensive data expected later in 2026 [51] Question: What are the estimates on acute pancreatitis events accrual based on patient baseline characteristics? - Management noted that it is challenging to predict events due to the use of modified Atlanta criteria, but they expect a good chance of having the necessary number of events [56]