Arrowhead Posts $724 Million Loss After Voucher Charge

The Tip Desk · November 12, 2026 · 4 min read

Full-year revenue was $450.8 million as the company booked a $215 million Priority Review Voucher and expanded REDEMPLO prescriptions.

Arrowhead Pharmaceuticals (ARWR) reported a net loss of $724.2 million, or $5.11 a share, for the fiscal year ended September 30, 2026, after booking a $215.0 million charge for an acquired Priority Review Voucher and spending more on research and commercial operations.

Revenue was $450.8 million, down from $829.4 million in the year ended September 30, 2025. Operating expenses were $1.158 billion, including $739.1 million of research and development, $202.0 million of selling, general and administrative costs, and $1.8 million of cost of product revenue. The company recorded an operating loss of $707.2 million, versus operating income of $98.3 million a year earlier.

President and CEO Christopher Anzalone said the company had “fundamentally changed over the past 12 months,” pointing to a commercial business around REDEMPLO, pivotal severe hypertriglyceridemia data, and an sNDA already filed with the U.S. Food and Drug Administration.

U.S. REDEMPLO prescriptions continued to build. New-to-brand prescriptions grew 63% quarter over quarter in the fiscal fourth quarter, with cumulative new-to-brand prescriptions of 950 as of quarter-end and an additional 300 received after the period. Weekly prescriptions reached approximately 50 to 60 per week, and more than 640 unique practitioners had prescribed the drug as of quarter-end, growing to over 860 since. More than 160 million lives in the United States were covered in payer formulary.

REDEMPLO became available in Germany after the European Commission’s June 2026 marketing authorization and is listed in the Lauer-Taxe database, being prescribed, dispensed, and reimbursed. The U.K. MHRA granted marketing authorization, and NICE issued Technology Appraisal guidance recommending NHS funding in England and Wales for genetically confirmed FCS when diet and conventional triglyceride-lowering therapies have been inadequate.

The FDA granted plozasiran entry in the STAR pilot program for the severe hypertriglyceridemia sNDA, qualifying a supplemental application for a 6-month Priority Review versus a 10-month standard review. Arrowhead retained the previously purchased Priority Review Voucher. The company submitted the sNDA and is preparing for a potential U.S. launch in the second quarter of 2027, pending successful regulatory filing, review, and approval.

SHASTA-3 and SHASTA-4 met the primary endpoint of triglyceride reduction versus placebo and all prespecified secondary endpoints, with median triglyceride reductions of 79% and 81% from baseline. At Month 12, more than 90% of plozasiran-treated patients in both studies achieved triglyceride levels below 500 mg/dL and more than half achieved levels below 150 mg/dL. Plozasiran reduced adjudicated acute pancreatitis events by 78% versus placebo; among patients with a history of prior pancreatitis the event rate was reduced by 91%.

Interim Phase 1/2a results for ARO-DIMER-PA showed mean PCSK9 reductions of 50% to 89% and APOC3 reductions of 43% to 95%, which the company said validated the TRiM platform’s ability to target two genes in one molecule. ARO-MAPT in healthy volunteers achieved a mean reduction of up to 73% in cerebrospinal fluid total tau at Day 105 and a maximum reduction of 85%, which the company described as the first successful clinical validation of siRNA delivery across the blood-brain barrier with substantial brain target knockdown. Enrollment in the Phase 3 YOSEMITE trial of zodasiran in homozygous familial hypercholesterolemia was completed, with target enrollment increased from 60 to 70 patients; the company anticipates completion in mid-2027.

Arrowhead refinanced an existing Sixth Street credit facility and established a new $400 million senior secured term loan at SOFR plus 5.50%, compared with an annual rate of 15% on the retired facility, with maturity in November 2031, a $68 million discount on the contractual prepayment amount, and elimination of required prepayment sweeps.

Cash, cash equivalents and restricted cash were $62.7 million at September 30, 2026, versus $226.5 million a year earlier. Available-for-sale securities were $1.130 billion and total cash resources were $1.193 billion. Deferred revenue was $113.0 million, versus $2.4 million a year earlier. Convertible notes, net, were $683.5 million, versus none a year earlier. The credit facility balance was $195.4 million. Total Arrowhead stockholders’ equity was $50.3 million, versus $466.1 million a year earlier. Shares outstanding were 141.3 million.

On November 9, 2026, the board approved a change in fiscal year end from September 30 to December 31, effective January 1, 2027. The company expects to file a transition report on Form 10-QT covering October 1 through December 31, 2026.