Arrowhead Pharmaceuticals

Pasadena, California · 49,000 · Corporate Headquarters · April 2027 · 1.5

Madison, Wisconsin · 110,956 · Research Facility · September 2031 · 5.9

San Diego, California · 144,000 · Research and Office Facility · April 2038 · 12.5

The Company owns land in the Verona Technology Park in Verona, Wisconsin, which has been developed into an approximately 160,000 square foot drug manufacturing facility and an approximately 140,000 square foot laboratory and office facility which will support the Company’s manufacturing process development and analytical activities. The Company completed the build out of one of its laboratory and office facilities during the first quarter of fiscal year 2024 and substantially completed the build out of its manufacturing facility during the first quarter of fiscal year 2025.

• Our clinical trials may reveal significant adverse events, toxicities or other side effects and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates.
• Clinical trials of our product candidates may not uncover all possible adverse events that patients may experience.
• Topline data may not accurately reflect the complete results of a particular study or trial.
• Results of earlier studies or clinical trials may not be predictive of future clinical trial results, and initial studies or clinical trials may not establish an adequate safety or efficacy profile for our product candidates to justify proceeding to advanced clinical trials or an application for regulatory approval.
• It may take us longer than we project to complete clinical trials, and we may not be able to complete them at all.
• We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability from REDEMPLO, or any other approved product candidate, and may have to limit its commercialization.
• The successful commercialization of REDEMPLO, or any other approved product candidates, will depend in part on the extent to which government authorities and health insurers establish adequate reimbursement levels and pricing policies.
• We may not enjoy the market exclusivity benefits of our orphan drug designations.
• Our success depends on the attraction and retention of senior management and scientists with relevant expertise.
• Our commercialization, collaborative and other arrangements may give rise to disputes over commercial terms, contract interpretation and ownership or protection of our intellectual property and may adversely affect the commercial success of our product candidates.
• Risks Related to Regulatory Review and Approval of Our Product Candidates
• Breakthrough Therapy designation for Fazirsiran (formerly ARO-AAT) and other of our current or future product candidates and other of our current or future product candidates may not lead to a faster development or review process.
• A Fast Track product designation may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
• We may seek priority review designation for one or more of our product candidates, but we might not receive such designation, and even if we do, such designation may not lead to faster development or regulatory review or approval process.
• We intend to deliver some of our product candidates via drug delivery devices that will have their own regulatory, development, supply and other risks.
• We and our licensees conduct clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
• Even if we obtain FDA approval for products in the United States, we may never obtain approval to commercialize any product candidates outside of the United States, which would limit our ability to realize their full market potential.
• If the FDA or comparable foreign regulatory authorities approve generic versions of REDEMPLO, or any other potential products that receive marketing approval, or such authorities do not grant REDEMPLO appropriate periods of data or market exclusivity before approving a generic version, the sales of REDEMPLO could be adversely affected.
• Failure to comply with regulatory requirements or unanticipated problems with our products may result in various adverse actions such as the suspension or withdrawal of one or more of our products, closure of a facility or enforcement of substantial penalties or fines.
• Pharmaceutical and biological product marketing is subject to substantial regulation in the U.S. and any failure by us or our commercial and collaborative partners to comply with applicable statutes or regulations can adversely affect our business.
• Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
• We are party to technology license agreements with third parties that require us to satisfy obligations to keep them effective and, if these agreements are terminated, our technology and our business could be seriously and adversely affected.
• We may be and have been subject to patent infringement claims, which could result in substantial costs and liability and prevent us from commercializing our potential products.
• We license patent rights from third-party owners and we rely on such owners to obtain, maintain and enforce the patents underlying such licenses.
• Our technology licensed from various third parties may be subject to retained rights.
• Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
• We may not be able to effectively secure first-tier technologies when competing against other companies or investors.
• We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
• Our business model assumes we will generate revenue by, among other activities, marketing or out-licensing the products we develop. Our product candidates are in various stages of development and we currently have only one product based on RNAi and our delivery technologies which was approved in November 2025. Accordingly, there is a limited amount of information about us upon which you can evaluate our business and prospects.
• We may need to establish additional relationships with strategic and development partners to fully develop our product candidates and market any approved products.
• Our ability to generate milestone and royalty payments under our current and potential future licensing and collaboration agreements is substantially controlled by our partners, and as such, we will likely need other sources of financing to continue to develop our internal product candidates.
• We may lose a considerable amount of control over our intellectual property and may not receive anticipated revenues in strategic transactions, particularly where the consideration is contingent on the achievement of development or sales milestones.
• We will need to achieve commercial acceptance of REDEMPLO and our product candidates to generate revenues and achieve profitability.
• If the market opportunities for REDEMPLO or any other approved product candidates, are smaller than we expect, it could materially adversely affect our financial condition and results of operation.
• We rely on outside sources for various components and processes for our products.
• We have limited manufacturing capability and must rely on third-party manufacturers to manufacture our clinical supplies and commercial products, if and when approved, and if they fail to meet their obligations, the development and commercialization of our products could be adversely affected.
• We rely on third parties to conduct our clinical trials, and if they fail to fulfill their obligations, the development of our products may be adversely affected.
• We face competition from various entities including large pharmaceutical companies, small biotech companies, private companies, and research institutions.
• We may have difficulty expanding our operations successfully as we evolve our pipeline and move toward commercializing drugs.
• Our business and operations could suffer in the event of a cybersecurity incident or other information technology system failures.
• Because we use biological materials, hazardous materials, chemicals and radioactive compounds, if we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
• Securities litigation claims may result in financial losses or harm our reputation and may divert management resources.
• Our operations, including our relationships with healthcare providers, physicians and third-party payers, are subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which, in the event of a violation, exposes us to liability for criminal sanctions, civil penalties, and contractual damages, and reputational harm and diminished profits and future earnings.
• The actions of distributors and specialty pharmacies could affect our ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such distributors and specialty pharmacies could adversely affect our revenues, financial condition, or results of operations.
• We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
• We will require substantial additional funds to complete our research and development activities.
• The terms of our financing agreement with Sixth Street Lending Partners and our indebtedness could adversely affect our operations and limit our ability to plan for or respond to changes in our business. If we are unable to comply with restrictions in the financing agreement, the repayment of our existing indebtedness could be accelerated.
• If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements prove inaccurate, our actual results may vary from those reflected in our accruals.
• Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
• The investment of our cash, cash equivalents and fixed income securities is subject to risks which may cause losses and affect the liquidity of these investments.
• Our ability to utilize net operating loss carryforwards and other tax benefits may be limited.
• We could be subject to additional tax liabilities.
• Our Board of Directors has the authority to issue shares of “blank check” preferred stock, which may make an acquisition of the Company by another company more difficult.
• We do not intend to declare cash dividends on our common stock.
• If securities or industry analysts do not publish research reports about our business or if they make adverse recommendations regarding an investment in our stock, our stock price and trading volume may decline.
• The market for purchases and sales of our common stock may be limited, and the sale of a limited number of shares could cause the price to fall sharply.
• Our common stock price has fluctuated significantly over the last several years and may continue to do so in the future, without regard to our results of operations and prospects.
• Stockholder equity interest may be substantially diluted in any additional equity issuances.
• We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse business consequences.
• Unfavorable global economic conditions, whether brought about by material global crises, health epidemics, military conflicts or war, geopolitical and tariffs or other trade disputes or other factors, may adversely affect our business and financial results.
• Drug development is time consuming, expensive and risky.
• The healthcare system is under significant financial pressure to reduce costs, which could reduce payment and reimbursement rates for drugs.
• Evolving regulatory standards, including as a result of changes in government leadership, make it difficult to accurately predict the likelihood of marketing approval even when clinical trials meet their endpoints.