Omeros (OMER) risk factors, FY2024 10-K

Risks Related to Our Product Candidates, Programs and Operations

1. 01Management has concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern
2. 02We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when needed we may be unable to complete the development and commercialization of our product candidates or to continue our other preclinical development programs
3. 03Our Credit Agreement places restrictions on our operating and financial flexibility and could, if we were to default, adversely affect our liquidity and ability to retain title to our assets
4. 04In addition to our Credit Agreement, our other indebtedness and liabilities and any future indebtedness could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations
5. 05Failure to obtain and maintain regulatory approval in the U.S. or in foreign jurisdictions would prevent us from commercializing and marketing our product candidates
6. 06The success of any product that we or our third-party business partners commercialize in the future will depend heavily on the pricing, availability and duration of adequate coverage or reimbursement for any such product from government, private and other third-party payers, both in the U.S. and in other countries
7. 07Our operating results are unpredictable and may fluctuate
8. 08Any of these risk factors, should one or more occur, could adversely affect our results of operations and financial condition and cause the trading price of our stock to decline
9. 09We are subject to extensive government regulation and the failure to comply with these regulations may have a material adverse effect on our operations and business
10. 10We may face difficulties from changes to current regulations as well as future legislation, including as a result of the new U.S. administration
11. 11Ingredients, excipients, test kits and other materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may adversely affect the development and commercialization of our product candidates
12. 12If our clinical trials or clinical protocols are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of approved products
13. 13Our product candidates may not successfully complete clinical development or be suitable for successful commercialization or generation of revenue through partnerships, and our preclinical programs may not produce product candidates that are suitable for clinical trials
14. 14It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection
15. 15Competitors may develop products that are less expensive, safer or more effective, or which may otherwise diminish or eliminate the success of any products that we may commercialize
16. 16The loss of members of our management team could substantially disrupt our business operations
17. 17We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to maintain our operations or grow effectively
18. 18We may encounter difficulties managing our growth, which could delay our business plans or adversely affect our results of operations
19. 19Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business
20. 20If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed
21. 21As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act
22. 22Cyber-attacks or other failures in telecommunications or information technology systems could result in information theft, data corruption and significant disruption of our business operations
23. 23Our stock price has been and may continue to be volatile, and the value of an investment in our common stock may decline
24. 24If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing shareholders would experience further dilution
25. 25If we or the third parties upon whom we rely are adversely affected by natural disasters or other events, our business continuity and disaster recovery plans may not adequately protect us from such interruptions
26. 26Anti-takeover provisions in our charter documents and under Washington law could make an acquisition of us, which may be beneficial to our shareholders, difficult and prevent attempts by our shareholders to replace or remove our current management
27. 27We have never declared or paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future