Codexis (CDXS) risk factors, FY2024 10-K

Risks Related to Our Business and Strategy

1. 01We have a history of net losses and we may not achieve or maintain profitability
2. 02We believe that our products are exempt from FDCA requirements, but FDA or other regulators may disagree and find that our products are subject to such requirements
3. 03We are dependent on a limited number of customers
4. 04Some of our product supply agreements with customers, if in place, have finite duration, may not be extended or renewed and generally do not require the customer to purchase any particular quantity or quantities of our products
5. 05If we are unable to develop and commercialize new products for the pharmaceutical, biotherapeutics, diagnostics and life science tools markets, our business and prospects will be harmed
6. 06A reduction or delay in government funding of research and development for our customers may adversely affect our business
7. 07The services and offerings we provide are highly complex, and if we encounter problems providing the services or support required, our business could suffer
8. 08Any productivity issues or higher-than-expected costs at our facilities could result in material and adverse impacts on our financial condition and results of operations
9. 09We are dependent on our collaborators, and our failure to successfully manage these relationships could prevent us from developing and commercializing many of our products and achieving or sustaining profitability
10. 10Even after collaboration relationships expire or terminate, some elements of the collaboration may survive. For instance, certain rights, licenses and obligations of each party with respect to intellectual property and program materials may survive the expiration or termination of the collaboration
11. 11We have invested significant resources to enable enzymatic nucleic acid synthesis, which is based on novel ideas and technologies that are largely unproven
12. 12Competitors and potential competitors who have greater resources and experience than we do may develop products and technologies that make ours obsolete or may use their greater resources to gain market share at our expense
13. 13We have investments in non-marketable securities, which may subject us to significant impairment charges
14. 14Ethical, legal and social concerns about genetically engineered products and processes could limit or prevent the use of our technology, products and processes and limit our revenues
15. 15As a result of our strategic shift and our refined focus on certain programs and business lines, we may fail to capitalize on other opportunities that may be more profitable or for which there is a greater likelihood of success
16. 16Given our change in strategic direction, we may receive limited revenue or no future value from certain of our existing license agreements
17. 17The timing of our customer orders and related product revenue recognition is unpredictable and may cause our operating results to vary significantly from quarter to quarter, which could adversely affect our stock price
18. 18Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations
19. 19We may need additional capital in the future in order to expand our business
20. 20If we engage in any acquisitions, we will incur a variety of costs and may potentially face numerous risks that could adversely affect our business and operations

Risks Related to Government Regulation

1. 21Even if our customers, future customers or collaborators obtain regulatory approval for any products utilizing our enzymes, such products will remain subject to ongoing regulatory requirements, which may result in significant additional expense
2. 22If we or our customers fail to comply with certain healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected
3. 23Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations
4. 24Compliance with European Union chemical regulations could be costly and adversely affect our business and results of operations
5. 25The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities

Risks Related to Intellectual Property

1. 26Our efforts to prosecute, maintain, protect and/or defend our intellectual property rights may not be successful
2. 27Litigation may be necessary to enforce our intellectual property rights, to protect our trade secrets, to determine the validity and scope of the proprietary rights of others, or to defend against claims of infringement, invalidity, misappropriation, or other claims
3. 28Our ability to compete may decline if we do not adequately prosecute, maintain, protect and/or defend our proprietary technology, products or services or our intellectual property rights
4. 29Third parties may claim that we are infringing, violating or misappropriating their intellectual property rights, which may subject us to costly and time-consuming litigation and prevent us from developing or commercializing our technology, products or services
5. 30We may be involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful
6. 31We may not be able to enforce our intellectual property rights throughout the world
7. 32If our biocatalysts, or the genes that code for our biocatalysts, are stolen, misappropriated or reverse engineered, others could use these biocatalysts or genes to produce competing products
8. 33Confidentiality and non-use agreements with employees, consultants, advisors and other third parties may not adequately prevent disclosures and non-use of trade secrets and other proprietary information

Risks Related to Owning our Common Stock

1. 34We are subject to anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders
2. 35Our quarterly or annual operating results may fluctuate in the future. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline
3. 36We do not intend to pay cash dividends for the foreseeable future
4. 37If securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business, our stock price and trading volume could decline
5. 38We face risks associated with our international business
6. 39Market and economic conditions may negatively impact our business, financial condition, and share price
7. 40Business interruptions resulting from disasters or other disturbances could delay us in the process of developing our products and could disrupt our sales. Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster or other disturbance
8. 41Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition
9. 42As we continue to expand into other foreign countries and jurisdictions, we may be subject to additional laws and regulations that may affect how we conduct business
10. 43Evolving expectations around corporate responsibility practices, specifically related to environmental, social and governance (“ESG”) matters, may expose us to reputational and other risks