Arrowhead Pharmaceuticals(ARWR) - 2025 Q3 - Quarterly Results

Overview and Recent Developments Management Commentary The CEO highlighted strong execution across discovery, clinical, regulatory, and business development, preparing for the potential commercial launch of plozasiran by November 18, 2025, and maintaining a strong balance sheet to advance its pipeline of innovative medicines - The company's pipeline has matured, with four Arrowhead-discovered candidates now in pivotal Phase 3 studies[2] - Arrowhead is building out its commercial capabilities to be launch-ready for plozasiran, pending regulatory approval on its November 18, 2025, PDUFA date[2] - Management expressed confidence in the company's strong balance sheet, believing it provides sufficient financial resources to advance multiple new medicines through clinical and regulatory processes[2] Key Corporate and Clinical Updates Arrowhead announced significant business and clinical milestones, including a major asset purchase agreement with Sanofi for plozasiran in Greater China, a $100 million milestone payment from Sarepta for ARO-DM1, and progress in multiple Phase 3 studies for plozasiran and zodasiran, alongside initiating a Phase 1/2a trial for its obesity candidate, ARO-ALK7 - Visirna Therapeutics, an Arrowhead subsidiary, signed an asset purchase agreement with Sanofi for plozasiran in Greater China, including a $130 million upfront payment and up to $265 million in potential approval milestones[3] - Earned a $100 million milestone payment from Sarepta Therapeutics for ARO-DM1, a treatment for type 1 myotonic dystrophy, with an additional $200 million milestone anticipated by the end of 2025[3] - Completed enrollment in three global Phase 3 studies for plozasiran in severe hypertriglyceridemia, with topline data expected in mid-2026[3] - Dosed the first subject in the YOSEMITE Phase 3 trial of zodasiran for homozygous familial hypercholesterolemia (HoFH), marking the company's fourth candidate to reach late-stage studies[4] - Initiated a Phase 1/2a clinical trial of ARO-ALK7, an investigational RNAi therapeutic for obesity, with a novel mechanism of action aimed at preserving lean muscle mass[4] Financial Performance Q3 2025 Operating Results For the third quarter ended June 30, 2025, Arrowhead reported revenue of $27.8 million, compared to no revenue in the same period last year, resulting in a net loss attributable to the company of $175.2 million, or ($1.26) per share, an increase from a net loss of $170.8 million, or ($1.38) per share, in Q3 2024, driven by higher R&D and G&A expenses that offset the newly generated revenue Q3 2025 vs Q3 2024 Operating Summary | Metric | Q3 2025 (in thousands) | Q3 2024 (in thousands) | | :--- | :--- | :--- | | Revenue | $27,767 | $0 | | Research and development | $162,368 | $152,431 | | General and administrative | $30,949 | $23,710 | | Total operating expenses | $193,317 | $176,141 | | Operating loss | ($165,550) | ($176,141) | | Net loss attributable to Arrowhead | ($175,241) | ($170,793) | | Net loss per share - Diluted | ($1.26) | ($1.38) | Financial Position As of June 30, 2025, Arrowhead's financial position strengthened year-over-year, with total cash resources increasing to $900.4 million from $681.0 million, total assets growing to $1.38 billion, total liabilities decreasing to $860.8 million, and total stockholders' equity significantly increasing to $522.3 million Financial Position Summary as of June 30 | Metric | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Total cash resources | $900,372 | $680,961 | | Total Assets | $1,380,612 | $1,139,802 | | Total Liabilities | $860,806 | $948,739 | | Total Arrowhead Stockholders' Equity | $522,313 | $185,444 | | Shares Outstanding | 138,144 | 124,376 | Corporate Information and Forward-Looking Statements About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals is a biopharmaceutical company that develops RNA interference (RNAi) therapeutics to treat intractable diseases by silencing the genes that cause them, utilizing a broad portfolio of RNA chemistries and delivery methods to induce rapid, deep, and durable knockdown of target genes - The company's core technology is RNA interference (RNAi), a natural cellular mechanism that inhibits gene expression to affect protein production[10] - Arrowhead's therapies are designed to silence specific genes that cause intractable diseases by leveraging this natural pathway of gene silencing[10] Conference Call Information The company hosted a conference call and live audio webcast on August 7, 2025, to discuss its fiscal 2025 third-quarter financial results, with a replay of the webcast available on the company's investor relations website - A conference call and webcast were held on August 7, 2025, at 4:30 p.m. ET to discuss the financial results[1][8] - Analysts wishing to participate in the call were required to pre-register to receive a dial-in number and a personalized PIN code[9] Safe Harbor Statement This press release contains forward-looking statements regarding the company's future financial performance, product pipeline, clinical trial progress, and collaborations, which are based on current expectations and subject to numerous risks and uncertainties that could cause actual results to differ materially, as detailed in the company's SEC filings - The press release includes forward-looking statements concerning projections of future financial performance, product pipeline expectations, anticipated regulatory submissions, and clinical program results[12][14] - Actual results may differ due to various risks, including the safety and efficacy of product candidates, regulatory decisions, the ability to finance operations, and other uncertainties described in SEC filings[14]