Novavax (NVAX) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We have a history of losses and our future profitability is uncertain
2. 02We will continue to require significant funding to maintain our current level of operations and fund the further development of our vaccine candidates
3. 03Economic and political uncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled
4. 04disruption or delay in the performance of our third-party contractors and suppliers. If such third parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected

Risks Related to Product Development and Commercialization

1. 05Because our vaccine product development and commercialization efforts depend on new and rapidly evolving technologies, our efforts may not succeed
2. 06The emergence and transmissibility of variants of the SARS-CoV-2 virus may affect market acceptance or sales of our COVID-19 Vaccine, and our strategy to develop new versions of our COVID-19 Vaccine to protect against certain variants may not be successful
3. 07competitors, these vaccine candidates prove less effective than competitors’ vaccines, or we are unable to successfully manufacture, distribute or market such vaccine candidates once approved, these shortcomings may lead to reputational harm, loss of market share, and adverse financial results
4. 08We are a biotechnology company and face significant risk in developing, manufacturing and commercializing our products
5. 09Because we depend on third parties to conduct some of our laboratory testing and clinical trials, and a significant amount of our vaccine manufacturing and distribution, we may encounter delays in or lose some control over our efforts to develop and supply products
6. 10We may have product liability exposure
7. 11If we are unable to effectively manufacture our COVID-19 Vaccine in sufficient quantities or at sufficient yields, we may experience delays or an adverse impact on product development, clinical trials, regulatory approvals and commercial distribution
8. 12depend substantially on SII for co-formulation, filling, and finishing our COVID-19 Vaccine, and any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders
9. 13We must identify vaccines for development with our technologies and establish successful third-party relationships
10. 14Even if we successfully commercialize any of our vaccine candidates, either alone or in collaboration, we face uncertainty with respect to pricing, third-party reimbursement and healthcare reform, all of which could be subject to change and could adversely affect any commercial success of our vaccine candidates
11. 15our product if sufficient amounts of our product are not available compared to that of our competitors or not procured by pharmacies or other providers
12. 16We have limited marketing capabilities, and if we are unable to enter into collaborations with marketing partners or develop our own sales and marketing capability, we may not be successful in commercializing any approved products
13. 17Our vaccine candidates may never achieve market acceptance even if we obtain full regulatory approvals
14. 18We may not be able to secure sufficient supplies of a key component of our adjuvant technology
15. 19Current or future regional relationships may hinder our ability to engage in larger transactions
16. 20Our product candidates are sensitive to shipping and storage conditions, which could subject our vaccine candidates to risk of loss or damage
17. 21Our vaccine candidates could become subject to a product recall which could harm our reputation, business, and financial results

Risks Related to Our Industry and Competition

1. 22Many of our competitors have significantly greater resources and experience, which may negatively impact our commercial opportunities and those of our current and future licensees
2. 23There is significant competition in the development of a vaccine against COVID-19 and a combined vaccine against COVID-19 and influenza, and we may never see returns on the significant resources we are devoting to our vaccine candidates

Risks Related to Regulatory and Compliance Matters

1. 24We may not succeed in obtaining full U.S. FDA licensure or foreign regulatory approvals necessary to sell our vaccine candidates
2. 25Our products might fail to meet their primary endpoints in clinical trials, meaning that we will not have the clinical data required to support regulatory approvals
3. 26We may fail to obtain regulatory approval for our prototype vaccine and for NVX-CoV2601 or for our other current or future product candidates on a timely basis or comply with our continuing regulatory obligations if approval is obtained
4. 27We expect that regulatory authorities will continue to monitor and assess SARS-CoV-2 evolution and recommend that manufacturers make corresponding updates to the composition of their COVID-19 vaccines at least annually
5. 28Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally
6. 29The regulatory pathway for our COVID-19 Vaccine is continually evolving and may result in unexpected or unforeseen challenges
7. 30The later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of a vaccine that had previously received regulatory approval in certain jurisdictions from the market
8. 31Fast Track Designation by the U.S. FDA, the issue of conditional marketing authorizations by the EMA or MHRA, or other regulatory acceleration options may not actually lead to a faster development or regulatory review or approval process and does not assure approval
9. 32Due to the recent change in presidential administration, we face uncertainty regarding potential regulatory developments that may adversely affect our business
10. 33Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner
11. 34For our product candidates, we will be subject to additional healthcare laws and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions

Risks Related to our Intellectual Property

1. 35Our success depends on our ability to maintain the proprietary nature of our technology
2. 36Failure to obtain trademark registrations for proposed product names/brands, in the U.S. or abroad, may adversely impact our business
3. 37Third parties may claim we infringe their intellectual property rights
4. 38We may become involved in litigation to defend or enforce our intellectual property or the intellectual property of our collaborators or licensors, which could be expensive and time-consuming
5. 39The scope, validity, and ownership of our patent claims may be challenged in various venues and, if we do not prevail, our ability to exclude competitors may be harmed, potentially reducing our ability to succeed commercially
6. 40Even if we are ultimately successful, defending any such challenges may cause us to incur substantial expenses and may require us to divert substantial financial and management resources that we would otherwise be able to devote to our business
7. 41We may need to license intellectual property from third parties and, if our right to use the intellectual property we license is affected, our ability to develop and commercialize our vaccine candidates may be harmed
8. 42If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries
9. 43If we do not obtain patent term extension and/or patent term adjustment in the U.S. under the Hatch-Waxman Act and similar extensions in foreign countries, our ability to exclude competitors may be harmed

Risks Related to Employee Matters, Managing Growth and Information Technology

1. 44Our business may be adversely affected if we do not successfully execute our business development initiatives
2. 45Our announced global restructuring and cost reduction plans may not result in anticipated reductions in combined research and development and selling, general, and administrative expenses and may disrupt our business
3. 46Security breaches and other disruptions to our information technology systems or those of the vendors on whom we rely could compromise our information and expose us to liability, reputational damage, or other costs
4. 47Collaborations and contracts of our wholly owned subsidiary Novavax AB with partners such as Sanofi, with regional partners, such as SII, Takeda and SK bioscience, as well as with international providers, expose us to additional risks associated with doing business outside the U.S
5. 48If we are unable to attract or retain key management or other personnel, our business, operating results and financial condition could be materially adversely affected

Risks Related to Our Convertible Senior Notes

1. 49Servicing our 5.00% convertible senior unsecured notes due 2027 requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt
2. 50We may not have the ability to raise the funds necessary to repurchase the Notes as required upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the Notes

Risks Related to Ownership of Our Common Stock

1. 51Because our stock price has been and will likely continue to be highly volatile, the market price of our common stock may be lower or more volatile than expected
2. 52Raising additional capital by issuing securities or through collaboration and licensing arrangements may cause dilution to existing stockholders or require us to relinquish rights to our technologies or vaccine candidates
3. 53Provisions of our Second Amended and Restated Certificate of Incorporation and Amended and Restated By-Laws and Delaware law could delay or prevent the acquisition of the Company, even if such acquisition would be beneficial to stockholders, and could impede changes in our Board
4. 54We have never paid dividends on our capital stock, and we do not anticipate paying any such dividends in the foreseeable future
5. 55Litigation or regulatory investigations could have a material adverse impact on our results of operation and financial condition
6. 56We or the third parties upon whom we depend may be adversely affected by natural or man-made disasters or public health emergencies, such as the COVID-19 pandemic
7. 57We are a target for public scrutiny, and our business may be impacted by unfavorable publicity
8. 58The increasing use of social media platforms presents new risks and challenges to our business