Arrowhead bought a $215 million review voucher. Then another route opened.
The annual report leaves the expense in place while Arrowhead keeps the voucher for possible future use or sale.
Arrowhead Pharmaceuticals paid $215 million for a voucher intended to speed the review of its next plozasiran application. Weeks later, the drug qualified for a different FDA review route that made the voucher unnecessary for that filing. The company still owns it.
The new annual report explains the financial consequence: the full $215 million remains an expense even though Arrowhead may use the voucher for another application or sell it. That helps explain a much larger annual loss as its first commercial drug gains prescriptions.
A plan changed between two financial reports
Research by Ticker Byline shows how the plan changed between Arrowhead's August update and November's annual report. In August, management intended to use the voucher for an application seeking broader use of plozasiran before the end of 2026. The purchase closed on September 14.
On October 7, Arrowhead announced entry into the FDA's Split Real Time Application Review, or STAR, pilot program. Accepted supplemental applications qualify for a six-month priority review, making a separate voucher unnecessary for this application. Arrowhead withdrew its notice of intent to use the voucher.
The medicine, sold as REDEMPLO, is already approved for adults with familial chylomicronemia syndrome, a rare condition involving very high blood triglyceride levels. The new application seeks approval for severe hypertriglyceridemia, a broader indication. Arrowhead says it has submitted that application, meeting its earlier year-end timing target, and is preparing for a potential U.S. launch in the second calendar quarter of 2027, subject to approval.
A $215 million expense, with options still attached
Arrowhead expensed the voucher when it bought it because it intended to use it for its own drug candidate. The later change in plans does not reverse that charge, its annual report says.
The company retains the option to use the voucher for a future application or sell it to another company. The annual report gives no sale plan or recovery price. The accounting expense therefore tells a different story from the voucher's remaining possibilities.
The annual loss was $724.2 million, compared with $1.6 million a year earlier. The voucher was one reason. Collaboration and licensing revenue also fell, while research spending and the costs of building a commercial business rose.
The drug launch is growing from a small revenue base
New-to-brand REDEMPLO prescriptions grew 63% from the previous quarter. Arrowhead reported 950 cumulative new-to-brand prescriptions by September 30 and another 300 since then.
Recognized product revenue was still only $6.6 million out of $450.8 million of annual revenue, about 1.5%. Collaboration and licensing agreements supplied the rest. Prescription growth and reported sales are different measures; the latter reflect deliveries and deductions such as rebates.
Arrowhead ended September with $1.19 billion in cash resources, including securities and restricted cash. On a consistent consolidated basis, that was about $409 million below June. The voucher payment is classified as an investing outflow, separate from the $271.9 million used by operations during the full year.
Its November refinancing also changes future cash demands by replacing interest added to the loan with quarterly cash payments. The next filings will show how commercial receipts and spending develop as Arrowhead pursues the broader launch and decides what to do with the unused voucher. Our Arrowhead company profile tracks the financial history, financing and regulatory milestones.