Arrowhead Pharmaceuticals(ARWR) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The net loss for Q1 2025 was $173.1 million, or$1.39 per share, compared to a net loss of $132.9 million, or$1.24 per share, in Q1 2024 [63] - Revenue for Q1 2025 was $2.5 million, down from$3.6 million in Q1 2024, primarily due to changes in collaboration agreements [64] - Total operating expenses increased to $163.9 million in Q1 2025 from$140.1 million in Q1 2024, driven by higher candidate costs and salaries [65] Business Line Data and Key Metrics Changes - The company closed a significant collaboration agreement with Sarepta Therapeutics, which includes a $500 million upfront payment and potential total cash payments exceeding$1.375 billion [2][4] - The deal allows Arrowhead to focus on its cardiometabolic pipeline, particularly in obesity and CNS areas, while reducing R&D expenses as Sarepta assumes clinical development responsibilities [6][7] Market Data and Key Metrics Changes - The FDA accepted the NDA for plozasiran, with a PDUFA action date set for November 18, 2025, marking a significant milestone for the company [27][34] - The company anticipates a commercial launch of plozasiran in the U.S. and potentially in the EU, pending regulatory approvals [70][106] Company Strategy and Development Direction - Arrowhead aims to build a robust cardiometabolic pipeline, focusing on plozasiran, obesity treatments, and CNS programs, with a strategy to partner non-core assets for capital [8][16] - The company is also exploring additional obesity candidates and plans to expand its presence in the cardiometabolic space with new therapies targeting APOC3 and PCSK9 [22][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential driven by plozasiran, obesity programs, and CNS pipeline, with expectations for multiple key events in 2025 [69] - The company believes it is well-positioned for growth through 2028, supported by the recent capital infusion from the Sarepta agreement [8][67] Other Important Information - Arrowhead's cash and investments totaled $552.9 million at the end of Q1 2025, with pro forma cash expected to reach$1.4 billion after accounting for the Sarepta agreement [67] - The company is on track to complete enrollment for several Phase III studies, which could lead to significant milestone payments [39][71] Q&A Session Summary Question: Can you elaborate on the obesity program ARO-INHBE? - The company is studying ARO-INHBE as both a monotherapy and in combination with tirzepatide, with no specific bogey set for data expectations [76][78] Question: What feedback are you receiving from doctors regarding APOC3? - Physicians remain enthusiastic about plozasiran, viewing it as highly differentiating based on its attributes [86][87] Question: What are the plans for plozasiran in Europe? - The company is planning for commercialization in European markets alongside a commercial partner [106] Question: How does plozasiran compare to olozarsen? - Key differentiators for plozasiran include a significant reduction in triglycerides, achieving guideline-directed risk thresholds, and a favorable safety profile with less frequent dosing [110][113] Question: What are the attractive targets for the adipose tissue targeting platform? - The company is evaluating various targets for obesity, type 2 diabetes, and lipodystrophy, with updates expected as they reach clinical stages [111][124]