Neurocrine Biosciences (NBIX) risk factors, FY2024 10-K

Risks Related to Our Company

1. 01We may not be able to continue to successfully commercialize INGREZZA or any of our product candidates if they are approved in the future
2. 02We may not be able to successfully launch CRENESSITY
3. 03The commercial success of INGREZZA and CRENESSITY will depend upon the acceptance of these products as safe and effective by the medical community and patients
4. 04We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced
5. 05Developments by others (including the development of generic equivalents) may render our product candidates or technologies obsolete or noncompetitive
6. 06Government and third-party payors may impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products or impose policies and/or make decisions regarding the status of our products that could limit our product revenues and delay sustained profitability
7. 07Only a small number of research and development programs ultimately result in commercially successful drugs
8. 08Our clinical trials may be delayed for safety or other reasons, or fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay their regulatory approval
9. 09We have increased the size of our organization and will need to continue to increase the size of our organization. We may encounter difficulties with managing our growth, which could adversely affect our results of operations
10. 10records, provide accurate, timely and reliable reports on our financial and operating results, or otherwise operate our business. Any of these consequences could have an adverse effect on our results of operations and financial condition
11. 11We may not be able to accomplish these tasks or successfully manage our operations and, accordingly, may not achieve our research, development and commercialization goals. Our failure to accomplish any of these goals could harm our financial results and prospects
12. 12If we are unable to retain and recruit qualified scientists and other employees or if any of our key senior executives discontinues his or her employment with us, it may delay our development efforts or impact our commercialization of INGREZZA, CRENESSITY, or any product candidate approved by the FDA in the future
13. 13Use of our approved products or those of our collaborators could be associated with side effects or adverse events
14. 14We depend on our current collaborators for the development and commercialization of several of our products and product candidates and may need to enter into future collaborations to develop and commercialize certain of our product candidates
15. 15We license some of our core technologies and drug candidates from third parties. If we default on any of our obligations under those licenses, or violate the terms of these licenses, we could lose our rights to those technologies and drug candidates or be forced to pay damages
16. 16Our customers are concentrated and therefore the loss of a significant customer may harm our business
17. 17Our future funding requirements will depend on many factors and we may need to raise additional capital to fund our business plan and our future research, development, commercial and manufacturing efforts
18. 18We expect to increase our expenses for the foreseeable future, and we may not be able to sustain growth and profitability
19. 19The independent clinical investigators and contract research organizations that we rely upon to conduct our clinical trials may not be diligent, careful or timely, or may make mistakes in the conduct of our trials
20. 20We are subject to ongoing obligations and continued regulatory review for INGREZZA and CRENESSITY. Additionally, our product candidates, if approved, could be subject to labeling and other post-marketing requirements and restrictions
21. 21The occurrence of any of these events may adversely affect our business, prospects and ability to achieve or sustain profitability on a sustained basis
22. 22If the market opportunities for our products and product candidates are smaller than we believe they are, our expected revenues may be adversely affected, and our business may suffer
23. 23Because our operating results may vary significantly in future periods, our stock price may decline
24. 24Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flows, financial condition or results of operations
25. 25Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts
26. 26The price of our common stock is volatile
27. 27There can be no assurance that any share repurchases will enhance long-term stockholder value
28. 28Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses
29. 29Increasing use of social media could give rise to liability and result in harm to our business
30. 30We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers

Risks Related to Our Industry

1. 31Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation Reduction Act of 2022, could adversely affect our business
2. 32If we are unable to protect our intellectual property, our competitors could develop and market products based on our discoveries, which may reduce demand for our products
3. 33Proposed healthcare reform, drug pricing measures and other prospective legislative initiatives could adversely affect our business
4. 34information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts
5. 35We could face liability if a regulatory authority determines that we are promoting INGREZZA, CRENESSITY, or any of our product candidates that receives regulatory approval, for “off-label” uses
6. 36Remote work has increased risks to our information technology systems and data, as certain of our employees work from home, utilizing network connections, computers and devices outside our premises, including at home, while in transit or in public locations
7. 37If we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed
8. 38The technologies we use in our research as well as the drug targets we select may infringe the patents or violate the proprietary rights of third parties
9. 39Our business operations may subject us to disputes, claims and lawsuits, which may be costly and time-consuming and could materially and adversely impact our financial position and results of operations
10. 40Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
11. 41We face potential product liability exposure far in excess of our insurance coverage
12. 42Our activities involve hazardous materials, and we may be liable for any resulting contamination or injuries
13. 43We are subject to stringent and changing obligations related to data privacy and information security. Our actual or perceived failure to comply with such obligations could have a material adverse effect on our reputation, business, financial condition or results of operations
14. 44Additionally, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information