Arrowhead Pharmaceuticals (ARWR) Q3 2026 earnings summary

Executive summary

• Positive top-line phase III results from SHASTA-3 and SHASTA-4 studies in severe hypertriglyceridemia (SHTG), with median triglyceride reductions of 79% and 81% at 12 months, and favorable safety profile with no new signals.

• REDEMPLO launch for familial chylomicronemia syndrome (FCS) continues to gain momentum, with prescription volume more than doubling quarter-over-quarter, over 400 unique practitioners prescribing, and expanding international approvals in the U.S., Canada, China, Australia, and EU.

• Priority review voucher acquired to accelerate U.S. regulatory review for plozasiran in SHTG, potentially shortening approval by four months.

• Commercial infrastructure is scaling to support broader launches, with field force expansion and payer coverage progressing rapidly.

• Key business highlights included new global licensing agreements, regulatory approvals for REDEMPLO in multiple regions, and strong clinical progress across the pipeline.

Financial highlights

• Revenue for the quarter ended June 30, 2026, was $75.3 million, up from $27.8 million year-over-year, driven by license and collaboration agreements and commercial sales of REDEMPLO.

• Net loss for the quarter was $194.3 million ($1.36 per share), compared to $175.2 million ($1.26 per share) in the prior year quarter.

• Operating loss for the quarter was $170.1 million, and $270.5 million for the nine months, reflecting increased R&D and commercial expenses.

• Cash and investments totaled $1.6 billion as of June 30, 2026, including $1.55 billion in available-for-sale securities.

• Commercial revenue from REDEMPLO was approximately $2.4 million, more than double the prior quarter.

Outlook and guidance

• sNDA submission for plozasiran in SHTG planned before year-end 2026, with accelerated review expected.

• Anticipated data readouts in September for ARO-DIMER-PA (dual PCSK9/APOC3 siRNA) and ARO-MAPT (CNS tauopathy program), and further obesity/MASH data in Q4.

• YOSEMITE phase III study in HoFH fully enrolled, with data expected in Q3 2027 and NDA filing by end of 2027.

• Management expects continued significant investment in R&D and commercialization as the pipeline advances and new products launch.

• Sufficient liquidity is expected to fund operations for at least the next twelve months.