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Dec 31, 2024
Arrowhead Pharmaceuticals Q1 2025 Earnings Report
Arrowhead Pharmaceuticals reported its fiscal first quarter 2025 earnings, highlighting a significant licensing agreement with Sarepta Therapeutics and the acceptance of its NDA for plozasiran by the U.S. FDA.
Key Takeaways
Arrowhead Pharmaceuticals reported a net loss of $173.085 million for the fiscal first quarter ended December 31, 2024, with total revenue of $2.5 million. The company emphasized its strategic achievements, including a major licensing deal with Sarepta Therapeutics worth up to $10 billion in potential milestones and the FDA's acceptance of its plozasiran NDA, positioning it for future growth and potential commercial launches.
Arrowhead signed and closed a licensing and collaboration agreement with Sarepta Therapeutics, receiving $825 million upfront ($500 million cash, $325 million equity investment) and eligibility for up to $10 billion in potential milestone payments.
The U.S. FDA accepted the New Drug Application (NDA) for investigational plozasiran for familial chylomicronemia syndrome, with a PDUFA action date of November 18, 2025.
Plozasiran's NDA submission is supported by positive findings from the Phase 3 PALISADE study, which met its primary and all key secondary endpoints, including significant reductions in triglycerides and acute pancreatitis incidence.
The company initiated Phase 1/2a clinical trials for ARO-INHBE and ARO-ALK7, both investigational RNAi therapeutics for obesity, and presented interim results for ARO-CFB for complement-mediated diseases.
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals
Forward Guidance
Arrowhead Pharmaceuticals is well-positioned for growth with plans for an independent commercial launch in 2025 and potential for multiple partner launches over the coming few years. The company is funded into 2028 with further cash runway potential from wholly owned candidates.
Positive Outlook
- Independent commercial launch planned for 2025.
- Potential for multiple partner launches in the coming years.
- Phase 3 studies of plozasiran in severe hypertriglyceridemia are on pace to be fully enrolled in 2025 with potential study completion in 2026.
- Emerging high-value potential in obesity and CNS programs entering early clinical studies.
- Currently funded into 2028 with further cash runway potential from wholly owned candidates providing opportunities for additional partnerships.
Challenges Ahead
- The report does not explicitly state negative forward guidance. However, potential risks include the impact of the ongoing COVID-19 pandemic on business.
- Safety and efficacy of product candidates are subject to ongoing evaluation.
- Decisions of regulatory authorities and the timing thereof could impact program timelines.
- The duration and impact of regulatory delays in clinical programs remain a risk.
- The likelihood and timing of future milestone and licensing fees are not guaranteed.