Prothena Corp. Public (PRTA) risk factors, FY2024 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 profitability
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. 05The agreements we entered into with Elan involve conflicts of interest and therefore may have materially disadvantageous terms to us
6. 06We have been, and may in the future be, adversely affected by business disruptions beyond our control, including outbreaks of epidemic, pandemic, or contagious disease, geopolitical turmoil, earthquakes or other natural disasters, and adverse weather events, including as a result of climate change
7. 07We may experience breaches or similar disruptions of our information technology systems or data
8. 08Changes 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. 09Our 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 candidates
2. 10done to the satisfaction of the European Medicines Agency (the “EMA”); and in other countries this must be done to the satisfaction of comparable regulatory authorities
3. 11We 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
4. 12In addition, funding provided by a collaborator might not be sufficient to advance drug candidates under the collaboration
5. 13If 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
6. 14We 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
7. 15The 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
8. 16This lengthy 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 prospects
9. 17The FDA or other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction
10. 18Even 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
11. 19Although we have obtained agreement with the FDA on a special protocol assessment (“SPA”) with regard to our Phase 3 AFFIRM-AL clinical trial of birtamimab, a SPA does not guarantee approval of birtamimab or any other particular outcome from regulatory review
12. 20Both 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
13. 21We 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. 22Even 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. 23Consequently, 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. 24If 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. 25If 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 harmed
5. 26The 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. 27Our drug candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated
7. 28We may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for supplemental market exclusivity
8. 29A 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 licensure
9. 30If 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. 31We 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. 32If we do not establish additional strategic collaborations, we may have to alter our research, development, and/or commercialization plans
3. 33Rentschler Biopharma SE (“Rentschler”) and Catalent Indiana, LLC (“Catalent Indiana”) are our third-party manufacturers of clinical supplies of birtamimab. We are dependent on Rentschler and Catalent Indiana to manufacture these clinical supplies
4. 34We are dependent on BMS, and its third-party manufacturers if applicable, to manufacture clinical supplies of BMS-986446
5. 35We 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. 36If 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. 37Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
3. 38patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and/or growth prospects
4. 39Obtaining 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
5. 40The lives of our patents may not be sufficient to effectively protect our products and business
6. 41We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
7. 42We may not be able to protect our intellectual property rights throughout the world
8. 43We 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
9. 44We depend, in part, on our licensors to file, prosecute, maintain, defend, and enforce patents and patent applications that are material to our business
10. 45We 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
11. 46Litigation 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 operate
12. 47challenge to our patents in the future. We cannot assure you that our drug candidates and other proprietary technologies we may develop will not infringe existing or future patents owned by third parties
13. 48If 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
14. 49We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
15. 50We may be subject to claims that our employees, collaborators, partners, contractors, or advisors have wrongfully used or disclosed alleged trade secrets of third parties
16. 51Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Our Ordinary Shares

1. 52The market price of our ordinary shares may fluctuate widely
2. 53Your percentage ownership in Prothena may be diluted in the future
3. 54If we are unable to maintain effective internal controls, our business could be adversely affected
4. 55We 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. 56Future changes to the tax laws relating to multinational corporations could adversely affect us
6. 57Irish law differs from the laws in effect in the United States and may afford less protection to holders of our ordinary shares
7. 58The operation of the Irish Takeover Rules may affect the ability of certain parties to acquire our ordinary shares
8. 59Irish 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. 60Irish 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)
10. 61We do not anticipate paying cash dividends, and accordingly, shareholders must rely on ordinary share appreciation for any return on their investment
11. 62Dividends paid by us may be subject to Irish dividend withholding tax
12. 63Prothena ordinary shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax