Arrowhead Loss Widens to $724.2 Million as It Eyes 2027 SHTG Launch

Arrowhead Pharmaceuticals reported a fiscal 2026 net loss of $724.2 million, against a loss of $1.6 million a year earlier, as the company spent to prepare REDEMPLO for a far larger market than the one currently paying for it. The figure anchors a year in which revenue fell to $450.8 million from $829.4 million, and management asked investors to trust prescriptions that have not yet become paid claims.

On the fiscal 2026 earnings call, held after the year ended Sept. 30, Arrowhead said it submitted a supplemental application on Nov. 2 seeking approval of REDEMPLO, also known as plozasiran, in severe hypertriglyceridemia (SHTG). The FDA accepted the filing into a pilot program that carries a six-month priority review framework and could deliver an earlier decision. A U.S. launch in the broader population would follow in the second quarter of 2027, if approval comes.

How fast is prescription demand actually growing?

CEO Chris Anzalone said Arrowhead had received 950 cumulative new-to-brand patient prescriptions as of Sept. 30, up 63% from the prior quarter's end. The company has since collected more than 300 additional prescriptions, and distinct prescribers have grown from more than 640 at year-end to more than 860.

Andy Davis, senior vice president and head of the global cardiometabolic franchise, said recent trends support roughly 50 to 60 new prescriptions per week, against a previously cited rate of 20 to 30. He also said more than 160 million people in the U.S. carry coverage for eligible patients under applicable payer policies.

The caveat came from the top. Anzalone described the path from prescription to payment as a "choke point." Patients and physicians must clear benefit verification and prior authorization before prescriptions become paid shipments. Davis said a quick-start bridge program and a patient assistance program exist for FCS, and Arrowhead expects a similar quick-start program for SHTG if approved. Anzalone also said it was too early to give financial guidance without an FDA decision, a final label and more payer experience. Prescriptions, in short, are a leading indicator, not revenue.

What does the clinical data support?

Arrowhead estimates 3 million to 3.5 million people in the U.S. have triglycerides above 500 mg/dL; its initial focus would be roughly 1 million higher-risk patients, including those with prior acute pancreatitis. The company continues to project $3 billion to $4 billion in eventual annual U.S. SHTG sales — a projection, not a booked figure. Davis said the U.S. wholesale acquisition cost would hold at $45,000 per patient per year across both indications.

In the SHASTA-3 and SHASTA-4 trials, median triglyceride reductions at month 12 were 79% and 81%, respectively. A pooled analysis showed a 78% reduction in cumulative acute pancreatitis events versus placebo, and 91% among patients with prior pancreatitis.

Chief Medical Officer James Hamilton said treatment-emergent adverse event rates were similar in pooled active and placebo groups. Worsening glycemic control appeared more often with plozasiran, at 14.3% versus 8.7% for placebo; Hamilton said average blood sugar did not worsen progressively over time. The FDA will write the final label.

Where did the cash go?

• Operating expenses rose to approximately $1.16 billion from $731 million, including a one-time $215 million expense for a priority review voucher bought in September.
• CFO Dan Apel said the voucher is no longer needed for SHTG after the FDA pilot acceptance and is eligible for sale — though no sale agreement exists.
• Revenue included $317 million from the Sarepta collaboration and $89 million from Novartis; the prior year's larger total rested on Sarepta and Sanofi collaboration revenue.
• Cash and investments reached nearly $1.2 billion, up from roughly $900 million.
• On Nov. 2, Arrowhead refinanced its Sixth Street facility with a $400 million senior secured term loan due 2031, at a lower rate and without required cash sweeps.

What comes next in the pipeline?

Data from the phase 3 YOSEMITE study of zodasiran in homozygous familial hypercholesterolemia are expected in the second half of 2027, with a goal of filing a new drug application by year-end 2027 if results support it. Hamilton said additional ARO-DIMER-PA data, a therapy silencing both PCSK9 and APOC3, should arrive around mid-2027, with an initial approval strategy based on LDL cholesterol lowering, subject to regulatory agreement.

For ARO-MAPT, the central nervous system candidate, an interim healthy-volunteer analysis showed mean cerebrospinal fluid total tau fell 73% by day 105. Arrowhead is discussing studies in frontotemporal dementia and progressive supranuclear palsy while gathering more data before advancing later-stage Alzheimer's work. Asked about a competitor's soft SHTG launch, Anzalone said it had not changed Arrowhead's expectations, attributing the rival's result to communication and commercial execution.

The company has the cash, the prescriptions and the data; what it does not yet have is a label, a payer conversion rate, or a sale for its $215 million voucher.