Arrowhead Pharmaceuticals Reports Fiscal Year 2025 Financial Results and Highlights Major Regulatory and Clinical Milestones
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced its financial results for the fiscal year ending September 30, 2025, alongside a comprehensive review of recent scientific, clinical, and corporate advancements. The company will host a conference call and webcast on November 25, 2025, at 4:30 p.m. ET, during which executive leadership will discuss the annual performance, product pipeline progress, and strategic goals for the upcoming fiscal year.
Christopher Anzalone, Ph.D., President and Chief Executive Officer of Arrowhead, highlighted the significance of the year, describing it as transformational. “The recent FDA approval of REDEMPLO, indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), marks a pivotal milestone for Arrowhead,” he stated. “This approval represents not only the first and only FDA-authorized small interfering RNA (siRNA) therapy for individuals diagnosed with FCS, but also the first regulatory approval for a therapy developed using Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform. Our progress underscores how far the company has come, yet we believe our most impactful accomplishments still lie ahead.”
Dr. Anzalone added that Arrowhead is now entering a new phase of execution as a commercial-stage company. With robust discovery programs, expanding clinical activity, strategic partnerships, and multiple potential product launches anticipated in future years, the company is positioned for sustained growth and expanded presence across multiple therapeutic categories.
Webcast and Conference Call Information
Investors and stakeholders may access a live audio webcast via the “Events and Presentations” section of the Arrowhead website under the Investors tab. A replay will be available within two hours after the call concludes.
Analysts wishing to participate in the live call may register through the dedicated online portal, where they will receive a unique dial-in number and personalized PIN code required for entry.
Key Corporate and Clinical Updates
Over the past fiscal year, Arrowhead achieved significant milestones across regulatory, clinical, business development, and operational domains. Notable developments include:
FDA Approval of REDEMPLO (plozasiran)
The U.S. Food and Drug Administration (FDA) granted approval for REDEMPLO, a first-in-class siRNA therapy designed to reduce triglycerides in adults with familial chylomicronemia syndrome. FCS is an ultra-rare and severe metabolic disorder estimated to affect approximately 6,500 people in the United States. Patients with FCS exhibit triglyceride levels that may be between 10–100 times higher than normal, significantly increasing the risk of recurrent, acute, and life-threatening pancreatitis.
Key differentiators of REDEMPLO include:
- First and only siRNA treatment available for patients with FCS
- Self-administered through a subcutaneous injection once every three months
- First therapy evaluated in both genetically confirmed and clinically diagnosed FCS patient populations
- Strong Phase 3 PALISADE clinical trial results showing an 80% reduction in triglycerides from baseline and lower numerical incidence of acute pancreatitis compared with placebo
Arrowhead also introduced the One-REDEMPLO pricing model, offering a unified pricing strategy across current and future potential FDA-approved indications. In parallel, the company launched Rely On REDEMPLO, a patient access and support program providing resources, financial assistance pathways, and long-term care coordination.
Strategic Partnerships and Licensing Advancements
Arrowhead significantly expanded its global collaboration footprint through a major partnership with Novartis. Under this agreement, Novartis acquired global rights to ARO-SNCA, a preclinical siRNA therapy targeting alpha-synuclein for potential treatment of synucleinopathies, including Parkinson’s disease.
Financial components of this partnership include:
- $200 million upfront payment to Arrowhead
- Eligibility to receive up to $2 billion in clinical, regulatory, and commercial milestone payments
- Tiered royalties reaching the low double-digit percentage range on commercial sales
Additionally, Arrowhead received $300 million in milestone-based payments from Sarepta Therapeutics related to progress in clinical development of ARO-DM1, an investigational therapy for type 1 myotonic dystrophy. As part of the milestone structure, Arrowhead elected to accept approximately $50 million in company stock and $50 million in cash, resulting in a strategic share reduction and demonstrating strong confidence in long-term growth potential.
Another significant business development event included the signing of an asset purchase agreement between Visirna Therapeutics—a majority-owned Arrowhead subsidiary—and Sanofi. Under this agreement, Sanofi will commercialize investigational plozasiran in Greater China. Visirna will receive $130 million upfront and may receive an additional $265 million in regulatory milestone payments.
Pipeline and Research Progress
Arrowhead continued advancing its diversified RNA interference pipeline, including several first-in-class or platform-expanding candidates:
- ARO-DIMER-PA: Filed regulatory clearance request to begin Phase 1/2a studies. The therapy is the first dual-gene RNAi candidate to silence PCSK9 and APOC3 simultaneously, targeting mixed hyperlipidemia and atherosclerotic cardiovascular disease.
- ARO-MAPT: Filed regulatory clearance request for Phase 1/2a clinical initiation. This is the first RNAi therapeutic from Arrowhead designed to cross the blood–brain barrier using its next-generation delivery system and is being evaluated for tauopathies, including Alzheimer’s disease.
- Zodasiran: Initiation of patient dosing in the YOSEMITE Phase 3 clinical trial for homozygous familial hypercholesterolemia.
Fiscal Year 2025 Financial Results
Arrowhead reported meaningful financial growth, driven largely by collaboration revenue, milestone payments, and transition into commercialization.
Operating Performance (Year Ended September 30):
| Category | 2025 | 2024 |
|---|---|---|
| Revenue | $829.4M | $3.6M |
| Total Operating Expenses | $731.1M | $604.6M |
| Operating Income (Loss) | $98.3M | $(601.1M) |
| Net Income (Loss) | $30.1M | $(609.7M) |
| Net Income (Loss) Attributable to Arrowhead | $(1.63M) | $(599.49M) |
Revenue increased significantly year-over-year, driven by licensing payments and milestone achievements.
Financial Position
| Item | 2025 | 2024 |
|---|---|---|
| Total Cash Resources | $781.5M | $681.0M |
| Total Assets | $1.25B | $1.14B |
| Stockholders’ Equity | $466.1M | $185.4M |
| Shares Outstanding | 135.7M | 124.4M |
Arrowhead strengthened its balance sheet, improved liquidity, and increased shareholder equity—reflecting favorable capital strategy execution, major partnership inflows, and continued investor confidence.
As Arrowhead enters the next fiscal year, the company expects its commercial launch activities, ongoing clinical studies, regulatory submissions, and strategic partnerships to drive continued momentum. With multiple investigational therapies progressing toward late-stage development, the organization is preparing for future expansion into additional metabolic, cardiovascular, neurological, and rare disease markets.
Dr. Anzalone concluded, “We are energized by our trajectory. The approval of REDEMPLO was only the beginning. With multiple platforms advancing and partnerships accelerating potential global reach, Arrowhead is now positioned as a leader in RNAi drug development with commercial potential across a broad spectrum of diseases.”
REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.
For more information about REDEMPLO, visit Our Medicines.
Source Link: https://www.businesswire.com/
