Jazz Pharmaceuticals (JAZZ) risk factors, FY2024 10-K

Risks Related to Our Lead Products and Product Candidates

1. 01Our inability to maintain revenues from our oxybate franchise would have a material adverse effect on our business, financial condition, results of operations and growth prospects
2. 02New treatment options for cataplexy and EDS in narcolepsy have been commercially launched and, in the future, other products may be launched that are competitive with or disrupt the market for our oxybate products, Xywav and Xyrem
3. 03The distribution and sale of our oxybate products are subject to significant regulatory restrictions, including the requirements of a REMS and safety reporting requirements, and these regulatory and safety requirements subject us to risks and uncertainties, any of which could negatively impact sales of Xywav and Xyrem
4. 04for us and/or take a significant amount of time, any of which could materially and adversely affect our business, financial condition, results of operations and growth prospects
5. 05Our inability to maintain or increase sales of Epidiolex/Epidyolex would have a material adverse effect on our business, financial condition, results of operations and growth prospects
6. 06While we expect Xywav and Epidiolex/Epidyolex to remain our largest products, our success also depends on our ability to effectively commercialize our other existing products and potential future products
7. 07We face substantial competition from other companies, including companies with larger sales organizations and more experience working with large and diverse product portfolios, and competition from generic drugs
8. 08Recent executive and judicial changes and flux in the regulatory landscape creates uncertainty for us and our industry
9. 09In addition to access, coverage and reimbursement, the commercial success of our products depends upon their market acceptance by physicians, patients, third party payors and the medical community
10. 10Delays or problems in the supply of our products for sale or for use in clinical trials, loss of our single source suppliers or failure to comply with manufacturing regulations could materially and adversely affect our business, financial condition, results of operations and growth prospects

Risks Related to Growth of Our Product Portfolio and Research and Development

1. 11Our future success depends on our ability to successfully obtain and maintain regulatory approvals for our late-stage product candidates and, if approved, to successfully launch and commercialize those product candidates
2. 12We may not be able to successfully identify and acquire or in-license additional products or product candidates to grow our business, and, even if we are able to do so, we may otherwise fail to realize the anticipated benefits of these transactions

Risks Related to Our Intellectual Property

1. 13It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
2. 14Since Xyrem’s regulatory exclusivity has expired in the EU, we are aware that generic or hybrid generic applications have been approved by various EU regulatory authorities, and additional generic or hybrid generic applications may be submitted and approved
3. 15We have incurred, and may in the future incur, substantial costs as a result of litigation or other proceedings relating to patents, other intellectual property rights and related matters, and we may be unable to protect our rights to, or commercialize, our products
4. 16Leahy-Smith America Invents Act permits any person, whether they are accused of infringing the patent at issue or not, to challenge the validity of certain patents through a proceeding before the PTAB of the USPTO
5. 17With respect to our products and product candidates targeting rare indications, relevant regulatory exclusivities such as orphan drug exclusivity or pediatric exclusivity may not be granted or, if granted, may be limited
6. 18We have substantially expanded our international footprint and operations, and we may expand further in the future, which subjects us to a variety of risks and complexities which, if not effectively managed, could negatively affect our business
7. 19Significant disruptions of information technology systems or data security breaches could adversely affect our business
8. 20In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive data about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position
9. 21FDA and Equivalent Non-U.S. Regulatory Authorities
10. 22of these products exceeding historical sales on a named patient basis could have an adverse effect on our business, financial condition, results of operations and growth prospects
11. 23We are also subject to regulation by other regional, national, state and local agencies, including the DEA, the DOJ, the FTC, the United States Department of Commerce, the OIG, and other regulatory bodies, as well as similar governmental authorities in those non-U.S. countries in which we commercialize our products
12. 24of the Sunshine provisions or any other U.S. federal, state or local laws or regulations that may apply, or if we otherwise fail to comply with the Sunshine provisions or similar requirements of state or local regulators, we may be subject to significant civil, and administrative penalties, damages or fines
13. 25Further, legislation may be introduced at the state or Federal level that, if passed, would, among other things, modify the requirements of the 340B program
14. 26Product liability and product recalls could harm our business
15. 27We use hazardous materials in our manufacturing facilities, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive

Risks Related to Controlled Substances

1. 28Drug products approved for medical use by FDA that contain cannabis or cannabis extracts may be controlled substances and will be rescheduled to Schedules II-V after approval, or, like Epidiolex, removed completely from the schedules by operation of other laws
2. 29Our ability to research, develop and commercialize Epidiolex/Epidyolex is dependent on our ability to maintain licenses relating to the cultivation, possession and supply of botanical cannabis, a controlled substance
3. 30Controlled substance legislation differs between countries and legislation in certain countries may restrict or limit our ability to sell Epidyolex

Risks Related to Our Financial Condition and Results

1. 31We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position, and our business would be adversely affected if we are unable to service our debt obligations
2. 32Covenants in the Amended Credit Agreement and indenture governing our Secured Notes restrict our business and operations in many ways and if we do not effectively manage our covenants, our financial conditions and results of operations could be adversely affected
3. 33To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business
4. 34We have significant intangible assets and goodwill. Consequently, the future impairment of our intangible assets and goodwill may significantly impact our profitability
5. 35Our financial results have been and may continue to be adversely affected by foreign currency exchange rate fluctuations
6. 36Changes in our effective tax rates could adversely affect our business and financial condition, results of operations and growth prospects
7. 37Changes to tax laws relating to multinational corporations could adversely affect us
8. 38The IRS may not agree with the conclusion that we should be treated as a foreign corporation for U.S. federal tax purposes
9. 39Our ability to use NOLs and carryforward tax losses to offset potential taxable income is limited under applicable law and could be subject to further limitations if we do not generate taxable income in a timely manner or if certain “ownership change” provisions of applicable law result in further limitations

Risks Related to Our Ordinary Shares

1. 40The market price of our ordinary shares has been volatile and is likely to continue to be volatile in the future, and the value of your investment could decline significantly
2. 41We are subject to Irish law, which differs from the laws in effect in the U.S. and may afford less protection to holders of our securities
3. 42Our articles of association, Irish law, the Amended Credit Agreement and the indentures governing our Secured Notes and Exchangeable Senior Notes contain provisions that could delay or prevent a takeover of us by a third party
4. 43We have never declared or paid dividends on our capital stock and we do not anticipate paying dividends in the foreseeable future
5. 44If we fail to attract, retain and motivate members of our executive management team and key personnel, our operations and our future growth may be adversely affected
6. 45Anti-diversity, equity and inclusion initiatives could expose us to the risk of litigation or investigations, resulting in injunctions, penalties, or reputational harm
7. 46Our business and operations could be negatively affected if we become subject to shareholder activism or hostile bids, which could cause us to incur significant expense, hinder execution of our business strategy and impact our stock price