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Arrowhead Pharmaceuticals — 2026 Fiscal Year-End Earnings Summary

  • Financial Performance:

    • Revenue for the year ended September 30, 2026, was $450.8 million, a decrease from $829.4 million in the prior year.
    • Operating expenses totaled $1.16 billion for 2026, compared to $731.1 million in 2025, driven by a $215.0 million expense for an acquired Priority Review Voucher (PRV) and increased R&D and SG&A costs.
    • Research and development expenses increased to $739.1 million in 2026 from $607.2 million in 2025.
    • Selling, general, and administrative expenses rose to $202.0 million in 2026 from $123.9 million in 2025.
    • Operating loss for 2026 was $707.2 million, compared to operating income of $98.3 million in 2025.
    • Net loss attributable to Arrowhead Pharmaceuticals, Inc. was $724.2 million for 2026, versus a net loss of $1.6 million in 2025.
    • Diluted net loss per share was $5.11 in 2026, compared to $0.01 in 2025.
    • Total cash resources (cash, cash equivalents, restricted cash, and available-for-sale securities) were $1.19 billion as of September 30, 2026, up from $919.4 million in 2025.
    • Cash, cash equivalents, and restricted cash decreased to $62.7 million in 2026 from $226.5 million in 2025.
    • Available-for-sale securities increased to $1.13 billion in 2026 from $692.8 million in 2025.
    • Total liabilities increased to $1.69 billion in 2026 from $881.9 million in 2025.
    • Stockholders' equity decreased to $50.3 million in 2026 from $466.1 million in 2025.
    • Deferred revenue increased significantly to $113.0 million in 2026 from $2.4 million in 2025.
    • Convertible notes, net, increased to $683.5 million in 2026 from $0 in 2025.
    • The liability related to the sale of future royalties increased to $400.4 million in 2026 from $367.4 million in 2025.
  • Guidance and Future Outlook:

    • The Company plans to prepare for a potential U.S. launch of plozasiran for severe hypertriglyceridemia (sHTG) in the second quarter of 2027, pending successful regulatory filing, review, and approval.
    • The Company intends to seek marketing authorization for plozasiran in sHTG from additional global regulatory authorities with submissions planned in the future.
    • The YOSEMITE Phase 3 clinical trial of zodasiran is anticipated to be completed in mid-2027, with plans to seek regulatory approval in multiple geographies thereafter.
    • The Company expects to file a transition report on Form 10-QT covering the three-month period from October 1, 2026, through December 31, 2026, following a change in fiscal year-end.
  • Business Segments and Product Lines:

    • REDEMPLO (plozasiran) launch in the U.S. for familial chylomicronemia syndrome (FCS) showed momentum with new-to-brand prescriptions growing 63% quarter-over-quarter.
    • Cumulative new-to-brand REDEMPLO prescriptions reached 950 by the end of the quarter, with an additional 300 received shortly thereafter.
    • Weekly REDEMPLO prescriptions grew to approximately 50-60 per week.
    • More than 640 unique practitioners prescribed REDEMPLO by the end of the quarter, growing to over 860 subsequently.
    • REDEMPLO coverage expanded to 160 million lives in the U.S. payer formulary.
    • REDEMPLO received marketing authorization in Germany and the United Kingdom for FCS treatment.
    • The U.S. FDA granted plozasiran entry into the Split Real Time Application Review (STAR) pilot program for the sHTG indication, qualifying for a 6-month Priority Review.
    • Phase 3 SHASTA-3 and SHASTA-4 studies for plozasiran in sHTG met primary and secondary endpoints, showing median triglyceride reductions of 79% and 81%, respectively.
    • In SHASTA-3 and SHASTA-4, over 90% of treated patients achieved triglyceride levels below 500 mg/dL at Month 12, with more than half below 150 mg/dL.
    • Plozasiran reduced adjudicated acute pancreatitis events by 78% versus placebo in sHTG studies.
    • PALISADE open-label extension data showed median triglyceride reductions of 76% and APOC3 reductions of 89% through 24 months of treatment in FCS patients.
    • Interim results for ARO-DIMER-PA, a dual-functional RNAi therapeutic for atherosclerotic cardiovascular disease, demonstrated mean reductions of 50-89% in PCSK9, 43-95% in APOC3, 26-65% in LDL-C, and 56-78% in triglycerides.
    • Interim results for ARO-MAPT, an investigational therapy for Alzheimer's disease, showed mean reductions of up to 73% in cerebrospinal fluid total tau in healthy volunteers.
    • Enrollment in the Phase 3 YOSEMITE trial for zodasiran in homozygous familial hypercholesterolemia (HoFH) was completed, with enrollment increased to 70 patients.
  • Market and Competitive Landscape:

    • REDEMPLO is the first and only siRNA treatment approved in the U.S., EU, UK, Canada, China, and Australia for FCS.
    • The Company holds rights to REDEMPLO in all geographies outside of Greater China, where Sanofi holds development and commercialization rights.
    • The FDA STAR pilot program aims to shorten review times for supplemental indications of already-approved drugs, with Arrowhead retaining its previously purchased Priority Review Voucher.
    • The Company positions itself as the leading innovator in siRNA therapies following the clinical validation of its TRiM platform for targeting two genes simultaneously and delivering siRNA across the blood-brain barrier.
  • Risks and Challenges:

    • Forward-looking statements regarding regulatory approval, commercial launch timing, and clinical trial results are subject to risks including safety and efficacy outcomes, pricing and reimbursement decisions, and regulatory delays.
    • Risks include the potential failure of clinical trials, inability to successfully commercialize REDEMPLO, competition from other therapies, and the risk that the STAR pilot program may not result in faster regulatory review.
    • The Company faces risks related to financing operations, servicing indebtedness, and complying with financing agreement restrictions.
    • The Company assumes no obligation to update forward-looking statements to reflect new events or circumstances.
  • Management Commentary and Tone:

    • CEO Christopher Anzalone stated the company has fundamentally changed from relying on scientific promise to translating promise into real patient outcomes and potential shareholder value growth.
    • Management expressed confidence in approaching 2027 with the strongest combination of near-term commercial opportunity and scientific capability in the company's history.
    • The tone emphasized building a commercial business around REDEMPLO and delivering pivotal data to pursue a larger market in severe hypertriglyceridemia.
  • Other Key Points:

    • The Company refinanced its credit facility with Sixth Street, establishing a new $400 million senior secured term loan facility maturing in November 2031.
    • The new credit facility carries an interest rate of SOFR plus 5.50%, a significant reduction from the 15% annual rate of the retired facility.
    • The refinancing eliminated contractual sweep obligations and reduced prepayment premiums, providing greater strategic and operational flexibility.
    • The Board of Directors approved a change in the fiscal year-end from September 30 to December 31, effective January 1, 2027.
    • The Company acquired a Priority Review Voucher for $215.0 million during the fiscal year.
    • Shares outstanding increased to 141.3 million in 2026 from 135.7 million in 2025.
Company
ARROWHEAD PHARMACEUTICALS INC
Sector
Healthcare
Industry
Biotechnology