Prothena Corp. Public (PRTA) risk factors, FY2025 10-K

Risks Relating to Our Financial Position, Our Need for Additional Capital, and Our Business

1. 01We anticipate that we will incur losses for the foreseeable future and we may never sustain profitability45% rewritten
2. 02We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize drug candidates
3. 03Our future success depends on our ability to retain key personnel and to attract, retain, and motivate qualified personnel
4. 04Our collaborators, prospective collaborators, and suppliers may need assurances that our financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with us
5. 05We have been, and may in the future be, adversely affected by business disruptions beyond our control, including outbreaks of epidemic, pandemic, or contagious disease, trade policies or geopolitical turmoil, earthquakes or other natural disasters, and adverse weather events, including as a result of climate change
6. 06We may experience breaches or similar disruptions of our information technology systems or data
7. 07Changes in and failures to comply with U.S. and foreign privacy and data protection laws, regulations, and standards may adversely affect our business, operations, and financial performance

Risks Related to the Discovery, Development, and Regulatory Approval of Drug Candidates

1. 08Our success is largely dependent on the success of our research and development programs. Our drug candidates are in various stages of development and we may not be able to successfully discover, develop, obtain regulatory approval for, or commercialize any drug candidates62% rewritten
2. 09We have entered into collaborations with Roche and BMS and may enter into additional collaborations in the future, and we might not realize the anticipated benefits of such collaborations
3. 10In addition, funding provided by a collaborator might not be sufficient to advance drug candidates under the collaboration
4. 11If clinical trials of our drug candidates are prolonged, delayed, suspended, or terminated, we may be unable to commercialize our drug candidates on a timely basis, if at all, which would require us to incur additional costs and delay or prevent our receipt of any revenue from potential product sales
5. 12We are dependent upon BMS with respect to further development of BMS-986446, including the Phase 2 clinical trial and any future clinical trial of that drug candidate
6. 13The regulatory approval processes of the FDA, the EMA, and other comparable regulatory authorities are lengthy, time consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed
7. 14This lengthy, complex approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our drug candidates, which would significantly harm our business, results of operations, and/or growth prospects30% rewritten
8. 15The FDA or other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
9. 16Even if our drug candidates receive regulatory approval in one country or jurisdiction, we may never receive approval or commercialize our products in other countries or jurisdictions
10. 17Both before and after marketing approval, our drug candidates are subject to ongoing regulatory requirements and continued regulatory review, and if we fail to comply with these continuing requirements, we could be subject to a variety of sanctions and the sale of any approved products could be suspended
11. 18We deal with hazardous materials and must comply with environmental laws and regulations which can be expensive and restrict how we do business

Risks Related to the Commercialization of Our Drug Candidates

1. 19Even if any of our drug candidates receives regulatory approval, if such approved product does not achieve broad market acceptance, the revenues that we generate from sales of the product will be limited
2. 20Consequently, even if we discover, develop, and commercialize a product, the product may fail to achieve broad market acceptance and we may not be able to generate significant revenue from the product
3. 21If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell approved products, we may be unable to generate product revenue
4. 22If government and third-party payers fail to provide coverage and adequate reimbursement rates for any of our drug candidates that receive regulatory approval, our revenue and prospects for profitability will be harmed56% rewritten
5. 23The markets for our drug candidates are subject to intense competition. If we are unable to compete effectively, our drug candidates may be rendered noncompetitive or obsolete
6. 24Our drug candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated
7. 25We may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity
8. 26A Fast Track designation by the FDA, even if granted for current or future drug candidates, may not lead to a faster development or regulatory review, licensure process and does not increase the likelihood that our drug candidates will receive marketing licensure84% rewritten
9. 27applications filed by sponsors of products granted Fast Track designation may qualify for priority review under FDA policies and procedures, but Fast Track designation does not assure any such review or ultimate marketing approval by the FDANew
10. 28value to physicians and other healthcare providers or require the disclosure of marketing expenditures and other pricing information; andNew
11. 29If a successful product liability or clinical trial claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, we could incur substantial liability

Risks Related to Our Dependence on Third Parties

1. 30We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of any such clinical trials
2. 31If we do not establish additional strategic collaborations, we may have to alter our research, development, and/or commercialization plans59% rewritten
3. 32candidates to be delayed, which could have an adverse effect on our business, financial condition, results of operations, and/or growth prospects100% rewritten
4. 33We are dependent on BMS, and its third-party manufacturers if applicable, to manufacture clinical supplies of BMS-986446
5. 34We depend on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business

Risks Related to Our Intellectual Property

1. 35If we are unable to adequately protect or enforce the intellectual property relating to our drug candidates our ability to successfully commercialize our drug candidates will be harmed
2. 36Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products24% rewritten
3. 37Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
4. 38The lives of our patents may not be sufficient to effectively protect our products and business
5. 39We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
6. 40We may not be able to protect our intellectual property rights throughout the world
7. 41We license patent rights from third-party owners. Such licenses may be subject to early termination if we fail to comply with our obligations in our licenses with third parties, which could result in the loss of rights or technology that are material to our business
8. 42We depend, in part, on our licensors to file, prosecute, maintain, defend, and enforce patents and patent applications that are material to our business
9. 43We may wish to form collaborations in the future with respect to our drug candidates, but may not be able to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans
10. 44Litigation regarding patents, patent applications, and other proprietary rights may be expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing drug candidates to market and harm our ability to operate84% rewritten
11. 45If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
12. 46We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
13. 47We may be subject to claims that our employees, collaborators, partners, contractors, or advisors have wrongfully used or disclosed alleged trade secrets of third parties
14. 48Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Our Ordinary Shares

1. 49The market price of our ordinary shares may fluctuate widely
2. 50Your percentage ownership in Prothena may be diluted in the future
3. 51If we are unable to maintain effective internal controls, our business could be adversely affected
4. 52We may not be able to successfully maintain our tax rates, which could adversely affect our business and financial condition, results of operations and growth prospects
5. 53Future changes to the tax laws relating to multinational corporations could adversely affect us
6. 54Irish law differs from the laws in effect in the United States and may afford less protection to holders of our ordinary shares
7. 55The operation of the Irish Takeover Rules may affect the ability of certain parties to acquire our ordinary shares
8. 56Irish law differs from the laws in effect in the United States with respect to defending unwanted takeover proposals and may give our board of directors less ability to control negotiations with hostile offerors
9. 57Irish stamp duty may be payable in respect of transfers of our ordinary shares (currently at the rate of 1% of the price paid or the market value of the shares acquired, if greater)52% rewritten
10. 58We do not anticipate paying cash dividends, and accordingly, shareholders must rely on ordinary share appreciation for any return on their investment
11. 59Dividends paid by us may be subject to Irish dividend withholding tax61% rewritten
12. 60with Ireland may be entitled to exemptions from Irish dividend withholding tax subject to the completion of certain dividend withholding tax declaration formsNew
13. 61Prothena ordinary shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax