Ionis Pharmaceuticals (IONS) risk factors, FY2025 10-K

Risks Related to the Commercialization of our Medicines

1. 01If the market does not accept our medicines, including our commercial medicines and our medicines in development, we are not likely to generate substantial revenues or become consistently profitable76% rewritten
2. 02If we or our partners fail to compete effectively, our medicines, including our commercial medicines and our medicines in development, will not generate significant revenues77% rewritten
3. 03These competitive advantages could make our medicines, including our commercial medicines and our medicines in development, obsolete or non-competitive80% rewritten
4. 04For details regarding medicines that compete or may compete directly with our marketed medicines and late-stage medicines, refer to the section titled, Competition, in Part I, Item 1, BusinessNew
5. 05Our medicines could be subject to regulatory limitations following approval84% rewritten
6. 06We depend on our collaborations with Biogen for the development and commercialization of SPINRAZA and QALSODY
7. 07We depend on our collaboration with AstraZeneca for the joint development and commercialization of WAINUA
8. 08If we are not successful in expanding our manufacturing capabilities or cannot manufacture our medicines or contract with a third party to manufacture our medicines at costs that allow us to charge competitive prices to buyers, we cannot market our products profitably

Risks Related to the Development and Regulatory Approval of our Medicines

1. 09If we or our partners fail to obtain regulatory approval for our medicines and additional approvals for our commercial medicines, we or our partners cannot sell them in the applicable markets
2. 10If the results of clinical testing indicate that any of our medicines are not suitable for commercial use, we may need to abandon one or more of our drug development programs
3. 11Even if our medicines are successful in preclinical and human clinical studies, the medicines may not be successful in late-stage clinical studies. Similarly, topline, preliminary or interim data we release for any of our clinical studies may not be indicative of full or final results from such study
4. 12We depend on third parties to conduct clinical studies for our medicines and any failure of those parties to fulfill their obligations could adversely affect our development and commercialization plans52% rewritten
5. 13Even with funding from corporate partners, if our partners do not effectively perform their obligations under our agreements with them, it would delay or stop the progress of our drug development and commercial programs
6. 14We may not be able to benefit from designations for our medicines from regulatory authorities that are intended to confer benefits such as financial incentives or an accelerated regulatory pathway

Risks related to our financial condition

1. 15If we fail to obtain timely funding, we may need to curtail or abandon some of our programs
2. 16We have incurred losses, and our business will suffer if we fail to consistently achieve profitability in the future
3. 17We may not be entitled to obtain additional milestone payments under our royalty monetization agreement with Royalty Pharma

Risks related to our intellectual property

1. 18If we cannot protect our patent rights or our other proprietary rights, others may compete more effectively against us
2. 19Intellectual property litigation could be expensive and prevent us from pursuing our programs21% rewritten

Risks related to product liability

1. 20We are exposed to potential product liability claims, and insurance against these claims may not be available to us at a reasonable rate in the future or at all

Risks related to our personnel

1. 21The loss of key personnel, or the inability to attract and retain highly skilled personnel, could make it more difficult to run our business and reduce our likelihood of success

Risks related to health epidemics, climate change and other events

1. 22Our business may be adversely affected by health epidemics, climate change, extreme weather events, fires, earthquakes, war, civil or political unrest, terrorism or disruptions of the U.S. government

Risks related to personal information, cybersecurity, social media and artificial intelligence

1. 23We are dependent on data as well as information technology systems and infrastructure, which exposes us to data protection risks29% rewritten
2. 24The increasing use of social media platforms presents new risks and challenges74% rewritten
3. 25We use artificial intelligence in certain aspects of our business, and challenges with properly managing its use could adversely affect our businessNew

Risks related to our securities and the global credit markets

1. 26If we do not progress in our programs as anticipated, the price of our securities could decrease
2. 27If the price of our securities continues to be highly volatile, this could make it harder to liquidate your investment and could increase your risk of suffering a loss
3. 28Negative conditions in the global credit markets and financial services and other industries may adversely affect our business, financial condition or stock price
4. 29Provisions in our certificate of incorporation, bylaws, convertible notes documents, call spread hedge transaction documents and Delaware law may prevent stockholders from receiving a premium for their shares32% rewritten
5. 30Future sales of our common stock in the public market could adversely affect the trading price of our securities23% rewritten

Risks related to compliance with laws

1. 31Our operations are subject to extensive legal and regulatory requirements affecting the health care industry
2. 32Because 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
3. 33Our business is subject to changing regulations for corporate governance and public disclosure that has increased both our costs and the risk of noncompliance

Risks related to taxes

1. 34Our ability to use our net operating loss carryovers and certain other tax attributes may be limited
2. 35Under the current U.S. federal income tax law, U.S. federal NOLs generated in taxable years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such U.S. federal NOLs is limited to 80 percent of taxable income
3. 36We could be subject to additional tax liabilities40% rewritten