ARROWHEAD PHARMACEUTICALS, INC. Q4 FY2025 earnings call

• Announced FDA approval of Rodemplo, the first FDA-approved medicine for FCS, marking a transition to commercial stage. Commercial team launched Rodemplo a week after approval and launched patient support program.
• Pipeline updates: zodasiran Phase III trial dosed first subject; Aerodimer PA filed for Phase III trial; ARO MAPT filed CTA for Phase III CNS trial; progress on obesity programs; business development milestones with Sarepta (earned $200M milestone) and Novartis (licensing collaboration with $200M upfront).
• Financials: Total operating expenses increased, but cash runway sufficient to extend to fiscal 2028.

There is no detailed breakdown of financial performance by traditional product segments. Net loss for fiscal year 2025 was $2 million with a loss of $0.01 per share. Revenue for fiscal year 2025 totaled $829 million, driven entirely by license and collaboration agreements with Sarepta, Sanofi, and GSK.

• No detailed financial guidance for fiscal 2026 provided. Commercial sales of Rodemplo not expected to materially impact 2026 financials. Cash runway expected to extend to fiscal 2028 even without additional capital.

• Risks associated with forward-looking statements, including numerous uncertainties that could cause actual results to differ from forward-looking statements. Regulatory uncertainties in clinical trial outcomes and market adoption of products.

Q: Luca Issy asks about Shasta 3 and 4's plan to show acute pancreatitis benefit.

A: Bruce Given responds that Shasta 3 and 4 were powered on triglyceride reduction, but Shasta 5 is specifically designed for acute pancreatitis as a primary endpoint.

Q: Prakhar Agrawal asks about obesity program data disclosures for ARO Inhibit E and ARO ALK7.

A: James Hamilton states ARO Inhibit E has more mature data with biomarker, MRI, and safety data in cohorts, while ARO ALK7 will focus on monotherapy safety and knockdown data.

Q: Maury Raycroft asks about SHTG pivotal's patient baseline profile and AP adjudication criteria.

A: Bruce Given mentions adapting modified Atlanta criteria but is cautious about predicting AP events exactly as the criteria are new.

Q: Gina asks about ARO MAPT differentiation from failed anti-tau antibodies, CVOT visibility, and Sarepta milestones.

A: James Hamilton explains ARO MAPT's different delivery mechanism; Christopher Anzalone mentions Sarepta milestones in February and CVOT plans; Dan Appel confirms Sarepta milestones.

Q: Edward Tenthoff asks about ARO RAGE study and dimer applications.

A: Christopher Anzalone discusses ARO RAGE challenge study and dimer's potential in mixed hyperlipidemia; James Hamilton mentions other dimer applications in CV space.

Q: Mani Foroohar asks about Aerodimer application and data from Horizon.

A: Bruce Given and Christopher Anzalone discuss Aerodimer's potential in mixed hyperlipidemia and combining with other approaches.

Q: Patrick Trucchio asks about FDA clarity on pancreatitis evidence, pediatric pathway for FCS, and MAPT program biomarker response.

A: Bruce Given talks about FDA clarity not discussed specifically; no mention of pediatric pathway yet; James Hamilton mentions aiming for CSF tau reductions similar to NHP data.

Q: Andrea Newkirk asks about Rodemplo launch cadence.

A: Andy Davis states high ambitions for Rodemplo launch due to product attributes like sustained TG reduction and once-every-three-month dosing.

Q: Mike Ulz asks about adjustments to Shasta 3 and 4 studies after adopting modified Atlanta criteria.

A: Bruce Given and James Hamilton state no adjustments needed as design was negotiated with FDA and no changes were inspired.

Q: Madison Elsadi asks about neuromuscular franchise biomarker activity and dose.

A: James Hamilton defers to Sarepta on dose and biomarker activity details.

Q: Joseph Tome asks about dimer study patient anti-PCSK9 treatment proportion and study cutoffs.

A: James Hamilton states few patients on PCSK9 inhibitors in the study, and inclusion criteria include mixed hyperlipidemia with specific triglyceride and LDL cutoffs.