- Rodemplo FDA Approval & Launch: First siRNA therapy for FCS approved, priced at $60,000 annual WAC, with home administration and a $60M+ patient support program.
- Financial Milestones: $400M+ in milestone payments (Sarepta: $200M, Novartis: $200M) and $919M cash reserves as of Q3 2025, funding 20 drug candidates in clinical trials by 2025.
- Phase III Pipeline Expansion: Shasta 3/4 (750-patient SHTG trial) and MIRROR III (1,400-patient mixed hyperlipidemia) advancing Rodemplo label expansion, with data expected Q3 2026.
- Novel CNS & Obesity Programs: $200M Novartis deal for Parkinson’s therapy (ARO SNCA) and Phase I/IIa obesity candidates (ARO Inhibit E, ARO ALK7) initiating in 2024–2025.
Financial Performance and Key Drivers
The company's financial performance was characterized by substantial revenue growth, primarily driven by the milestone and upfront payments from its partners. The revenue of $829 million was a significant jump, enabling the company to maintain a strong financial position with $919 million in cash and investments as of September 30, 2025. The net loss of $2 million was relatively contained, indicating effective cost management.
Rodemplo Launch and Pipeline Progress
The company achieved a major milestone with the FDA approval of Rodemplo, the first and only FDA-approved siRNA medicine for people living with familial chylomicronemia syndrome (FCS). The commercial team successfully launched Rodemplo, with the drug available in the channel just one week after approval. Additionally, the company made progress on other pipeline programs, including the initiation of the Yosemite Phase III clinical trial of zidaziran and the filing of a request for regulatory clearance to initiate a Phase III clinical trial of Aerodimer PA.
Valuation and Growth Expectations
With a P/S Ratio of 10.84 and an EV/EBITDA of -134.32, the market is pricing in significant growth expectations for Arrowhead Pharmaceuticals. Analysts estimate next year's revenue growth at -53.7%, indicating a potential slowdown. However, the company's strong pipeline and recent milestones suggest potential for long-term growth. The ROE of -41.19% and ROIC of -9.06% reflect the company's current loss-making position, but the substantial cash reserves and ongoing collaborations provide a foundation for future investments.
Pipeline Updates and Future Prospects
The company has a robust pipeline with several programs in various stages of development. The Shasta 3 and Shasta 4 Phase III studies are expected to complete primary portions in mid-2026, with top-line data in the second half of 2026. Additionally, the company expects several data readouts in 2026, including obesity data, dimer data, and ARO MAPT data. The progress in these programs and the potential for future milestones and collaborations will be critical in driving the company's growth.