What the changes say
- The company relies heavily on third-party contract manufacturers for INGREZZA and CRENESSITY without internal manufacturing facilities.
- Growth has pushed employee headcount from roughly 200 to over 2,000.
- New risks highlight exposure to international tariffs, trade barriers, and global supply chain disruptions in Europe.
What changed since the prior 10-K
New
- NewRisks Related to Our Company
the product in their own territory. Consequently, a downward trend in prices of medicinal products in some countries could contribute to similar downward trends elsewhere, including in the U.S
Downward trends in medicinal product prices in certain countries could spread to the U.S. and negatively impact product pricing.
- NewRisks Related to Our Company
If any of these issues arise, it may delay and/or negatively impact the development and commercialization of drug candidates and, ultimately, our generation of product revenues
Lack of internal manufacturing capabilities forces reliance on third parties for INGREZZA and CRENESSITY, risking commercialization delays and higher costs.
- NewRisks Related to Our Company
Our current dependence upon third parties for the manufacture of our products may reduce our profit margin, if any, on the sale of INGREZZA, CRENESSITY, or our future products and our ability to develop and deliver products on a timely and competitive basis
Defaulting on third-party core technology and drug lead licenses could result in lost rights to key products and damages.
- NewRisks Related to Our Company
Compliance with changing laws, regulations and standards relating to various aspects of our business, including corporate governance, workforce initiatives and public disclosure, may result in additional expenses and failure to comply with such laws, regulations and standards could adversely affect our business
Complying with changing laws and corporate governance standards increases selling, general, and administrative expenses and management time.
- NewRisks Related to Our Industry
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects
Reliance on foreign contract manufacturers in Europe and international suppliers for APIs creates vulnerability to tariffs and trade barriers.
- NewRisks Related to Our Industry
Unlike many industries, our ability to pass increased costs to customers is limited by the structure of pharmaceutical pricing and reimbursement systems. As a result, cost increases due to tariffs may be difficult or impossible to pass through to customers
Pharmaceutical pricing structures limit the ability to pass increased tariff-driven R&D and material costs onto customers.
- NewRisks Related to Our Industry
Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations
Unfavorable macroeconomic conditions, bank failures, government shutdowns, and geopolitical conflicts threaten business operations and supply chains.
Dropped
- DroppedRisks Related to Our Company
records, 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
- DroppedRisks Related to Our Company
We 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
- DroppedRisks Related to Our Company
Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses
- DroppedRisks Related to Our Industry
information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts
Reworded
- 71% rewrittenRisks Related to Our Company
Changes 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
Updated tax law references to include the One Big Beautiful Bill Act (OBBBA) enacted in 2025 alongside prior tax acts.
- 62% rewrittenRisks Related to Our Industry
Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the IRA, could adversely affect our business
Maintained core wording regarding government drug pricing controls and the IRA while adjusting contextual flow.
Was: Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation Reduction Act of 2022, could adversely affect our business
- 59% rewrittenRisks Related to Our Company
There can be no assurance that any share repurchases will enhance long-term stockholder value
Added details regarding a new February 2025 share repurchase program authorizing up to $500 million of common stock.
- 56% rewrittenRisks Related to Our Company
We have increased the size of our organization and will need to continue to increase the size of our organization. Such increases may not be sufficient and we may encounter difficulties with managing our growth, which could adversely affect our results of operations
Updated total full-time employee headcount milestone from 1,800 to over 2,000.
Was: We 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
- 53% rewrittenRisks Related to Our Company
If 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
Refined wording slightly regarding competition for qualified scientific personnel among biotechnology, pharmaceutical, and healthcare entities.
- 50% rewrittenRisks Related to Our Industry
If 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
Retained the orphan drug designation exclusivity framework without substantive textual changes.
- 48% rewrittenRisks Related to Our Company
Use of our approved products or those of our collaborators could be associated with side effects or adverse events
Preserved the risk disclosure regarding side effects or adverse events associated with approved products and collaborators.
- 42% rewrittenRisks Related to Our Industry
Proposed healthcare reform, drug pricing measures and other prospective legislative initiatives could adversely affect our business
Maintained the discussion on federal and state proposals for prescription drug price controls and healthcare cost reduction.
- 40% rewrittenRisks Related to Our Company
If 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
- 39% rewrittenRisks Related to Our Company
Only a small number of research and development programs ultimately result in commercially successful drugs
- 36% rewrittenRisks Related to Our Company
We 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
- 36% rewrittenRisks Related to Our Industry
If 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
- 32% rewrittenRisks Related to Our Company
We 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
- 30% rewrittenRisks Related to Our Company
Government 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
- 29% rewrittenRisks Related to Our Company
Our customers are concentrated and therefore the loss of a significant customer may harm our business
- 27% rewrittenRisks Related to Our Company
We may not be able to continue to successfully commercialize INGREZZA or any of our product candidates if they are approved in the future
- 25% rewrittenRisks Related to Our Company
The price of our common stock is volatile
- 22% rewrittenRisks Related to Our Company
Developments by others (including the development of generic equivalents) may render our product candidates or technologies obsolete or noncompetitive
All 47 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Company
- 01We may not be able to continue to successfully commercialize INGREZZA or any of our product candidates if they are approved in the future27% rewritten
- 02We may not be able to successfully launch and commercialize CRENESSITY
- 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
- 04We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced
- 05Developments by others (including the development of generic equivalents) may render our product candidates or technologies obsolete or noncompetitive22% rewritten
- 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 profitability30% rewritten
- 07the product in their own territory. Consequently, a downward trend in prices of medicinal products in some countries could contribute to similar downward trends elsewhere, including in the U.SNew
- 08Only a small number of research and development programs ultimately result in commercially successful drugs39% rewritten
- 09Our 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
- 10We have increased the size of our organization and will need to continue to increase the size of our organization. Such increases may not be sufficient and we may encounter difficulties with managing our growth, which could adversely affect our results of operations56% rewritten
- 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 prospects32% rewritten
- 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 future53% rewritten
- 13Use of our approved products or those of our collaborators could be associated with side effects or adverse events48% rewritten
- 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
- 15If any of these issues arise, it may delay and/or negatively impact the development and commercialization of drug candidates and, ultimately, our generation of product revenuesNew
- 16Our current dependence upon third parties for the manufacture of our products may reduce our profit margin, if any, on the sale of INGREZZA, CRENESSITY, or our future products and our ability to develop and deliver products on a timely and competitive basisNew
- 17Our customers are concentrated and therefore the loss of a significant customer may harm our business29% rewritten
- 18Our 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
- 19We expect to increase our expenses for the foreseeable future, and we may not be able to sustain growth and profitability
- 20The 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
- 21We 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 restrictions36% rewritten
- 22The occurrence of any of these events may adversely affect our business, prospects and ability to achieve or sustain profitability on a sustained basis
- 23If 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 suffer40% rewritten
- 24Because our operating results may vary significantly in future periods, our stock price may decline
- 25Changes 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 operations71% rewritten
- 26Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts
- 27The price of our common stock is volatile25% rewritten
- 28There can be no assurance that any share repurchases will enhance long-term stockholder value59% rewritten
- 29Compliance with changing laws, regulations and standards relating to various aspects of our business, including corporate governance, workforce initiatives and public disclosure, may result in additional expenses and failure to comply with such laws, regulations and standards could adversely affect our businessNew
- 30Increasing use of social media could give rise to liability and result in harm to our business
- 31We 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
- 32Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the IRA, could adversely affect our business62% rewritten
- 33If 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 products36% rewritten
- 34Proposed healthcare reform, drug pricing measures and other prospective legislative initiatives could adversely affect our business42% rewritten
- 35International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
- 36Unlike many industries, our ability to pass increased costs to customers is limited by the structure of pharmaceutical pricing and reimbursement systems. As a result, cost increases due to tariffs may be difficult or impossible to pass through to customersNew
- 37We 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
- 38Remote 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
- 39Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operationsNew
- 40If we fail to obtain or maintain orphan drug designation or other regulatory exclusivity for some of our product candidates, our competitive position would be harmed50% rewritten
- 41The 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
- 42Our 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
- 43Our 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
- 44We face potential product liability exposure far in excess of our insurance coverage
- 45Our activities involve hazardous materials, and we may be liable for any resulting contamination or injuries
- 46We 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
- 47Additionally, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information
Other Neurocrine Biosciences 10-Ks
- FY2024 10-K risk factors44 risks
Commercialization of INGREZZA and new launch of CRENESSITY drive the business and dominate risk factors. Customer concentration with four specialty distributors represents 93% of product sales. Heavy dependence on third-party licenses, collaborations, and contract research organizations.
Filed Feb 10, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.