Biocryst Pharmaceuticals (BCRX) risk factors, FY2024 10-K

Financial and Liquidity Risks

1. 01We have incurred losses since our inception and may never achieve sustained profitability
2. 02We have sustained operating losses for the majority of our corporate history and expect to continue to incur operating losses and negative cash flows unless and until revenues reach a level sufficient to support ongoing operations
3. 03to complete the development and commercialization of our products and product candidates or continue operations” in this section for further discussion of the capital requirements for our development and commercialization efforts

Risks Relating to Drug Development and Commercialization

1. 04Our success depends upon our ability to manage our product candidate pipeline, advance our product candidates through the various stages of development, especially through the clinical trial process, and to receive regulatory approvals for the commercial sale of our product candidates
2. 05to comply with regulatory requirements and industry standards or meet contractual obligations in a timely manner or at all; and
3. 06If our development collaborations with third parties, such as our development partners, contractors and contract research organizations, fail, the development of our product candidates will be delayed or stopped
4. 07If we fail to obtain additional financing or acceptable partnership arrangements if and when needed, we may be unable to complete the development and commercialization of our products and product candidates or continue operations
5. 08If we or our partners do not obtain regulatory approvals for our product candidates or maintain regulatory approvals for our products, we or our partners will not be able to commercialize and sell these products and potential products, which would significantly harm our business because we will receive no revenue
6. 09We focus primarily on rare diseases, which may create additional risks and challenges, including that the target patient populations of our products and product candidates may be small
7. 10following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference-listed drug is typically lost to the generic drug
8. 11The commercial viability of any approved product could be compromised if the product is less effective than expected, causes undesirable side effects that either were not previously identified or were worse than expected, or fails to achieve market acceptance within the medical community
9. 12The results of our partnership with Torii may not meet our current expectations
10. 13There can be no assurance that our or our partners’ commercialization efforts, methods, and strategies for our products or technologies will succeed, and our future revenue generation is uncertain
11. 14We have expanded, and may continue expanding, our development and regulatory capabilities and are implementing sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
12. 15Commercialization of our products by us and our partners is subject to the potential commercialization risks described herein and numerous additional risks. Any potential revenue benefits to us, including in the form of milestone payments, royalties or other consideration, are highly speculative

Risks Relating to Competing in Our Industry

1. 16We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced
2. 17Developments by others may render our products, product candidates, or technologies obsolete or noncompetitive
3. 18If one or more of our competitors’ products or programs, including potential competitors not currently identified, are successful, the market for our products may be reduced or eliminated

Legal and Regulatory Risks

1. 19We are subject to various laws and regulations related to our products and product candidates, and if we or our partners do not comply with these laws and regulations, we could face substantial penalties
2. 20kickback, false claims or similar laws. Violations of the federal Physician Payment Sunshine Act and similar legislation or the fraud and abuse laws may be punishable by civil or criminal sanctions, including fines and civil monetary penalties, and future exclusion from participation in government healthcare programs
3. 21We cannot predict the likelihood, nature or extent of government regulation or other measures that may arise from future legislation or administrative or executive action, either in the United States or abroad
4. 22Our employees, consultants and partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
5. 23We and our partners may be subject to new legislation, regulatory proposals and healthcare payor initiatives that may increase our costs of compliance and adversely affect our or our partners’ ability to market our products or develop our product candidates
6. 24We may be subject to data privacy and security risks, and our actual or perceived failure to comply with regulations and other legal obligations related to privacy and data protection could harm our business
7. 25If, because of our use of hazardous materials, we violate any environmental controls or regulations that apply to such materials, we may incur substantial costs and expenses in our remediation efforts
8. 26If we fail to adequately protect or enforce our intellectual property rights, the value of those rights would diminish, and if we fail to secure the rights to patents of others, it could adversely affect our business
9. 27We may be involved in legal proceedings to protect or enforce our patents, the patents of our partners or our other intellectual property rights, which could be expensive, time consuming and unsuccessful
10. 28We have diversified our pipeline to include the development of protein therapeutics, which may create additional risks and challenges
11. 29Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
12. 30We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
13. 31We face an inherent risk of liability in the event that the use or misuse of our products or product candidates results in personal injury or death, and our product liability insurance coverage may be insufficient

Risks Relating to Contractual Arrangements

1. 32We face risks related to our U.S. Government contracts, which may create a disadvantage and additional risks to us
2. 33If we fail to reach milestones or to make annual minimum payments or otherwise breach our obligations under our license agreements, our licensors may terminate our agreements with them and/or seek additional remedies
3. 34The covenants contained in the Pharmakon Loan Agreement could cause us to be unable to pursue business opportunities that we or our stockholders may consider beneficial without the lenders’ permission or without repaying all outstanding obligations under the Pharmakon Loan Agreement

Risks Relating to International Operations

1. 35International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, and economic risks
2. 36Any of these factors could significantly harm our international expansion of operations and adversely affect our business and results of operations
3. 37Foreign currency exchange rate fluctuations could have an adverse impact on our results of operations, financial position, and cash flows
4. 38Our actual or perceived failure to comply with European governmental laws and regulations and other legal obligations related to privacy, data protection and information security could harm our business
5. 39The United Kingdom’s decision to withdraw from the European Union could result in increased regulatory and legal complexity, which may make it more difficult for us to do business in Europe and impose additional challenges in securing regulatory approval of our product candidates in Europe

Risks Relating to Technology

1. 40If our facilities, or the facilities of our third-party vendors, incur damage or power is lost for a significant length of time, our business will suffer
2. 41Cyber incidents and related disruptions in our or our third-party vendors’ information technology systems could adversely affect our business
3. 42We have experienced cybersecurity threats and incidents, which to date have not had a material impact on our reputation, business, financial condition, or operations; however; there is no assurance that such impacts will not be material in the future
4. 43From time to time, we use artificial intelligence in our business, and challenges with properly managing its use could adversely affect our business

Other Operational Risks

1. 44Our business, operations, clinical development or commercialization plans and timelines, and access to capital could be adversely affected by unpredictable and unstable market and economic conditions
2. 45Insurance coverage is increasingly more costly and difficult to obtain or maintain
3. 46If we fail to retain our existing key personnel or fail to attract and retain additional key personnel, the development of our product candidates, the commercialization of our products, and the related expansion of our business will be delayed or stopped
4. 47If our risk management committee and other compliance methods are not effective, our business, financial condition and operating results may be adversely affected
5. 48Our business and operations could be negatively affected if we become subject to stockholder activism or hostile bids, which could cause us to incur significant expense, hinder execution of our business strategy and impact our stock price

Risks Relating to Investing in Our Common Stock

1. 49Our existing principal stockholders hold a substantial amount of our common stock and may be able to influence significant corporate decisions, which may conflict with the interest of other stockholders
2. 50Our stock price has been, and is likely to continue to be, highly volatile, which could cause the value of an investment in our common stock to decline significantly
3. 51Future sales and issuances of securities may dilute the ownership interests of our current stockholders and cause our stock price to decline
4. 52We have anti-takeover provisions in our corporate charter documents that may result in outcomes with which you do not agree
5. 53We have never paid dividends on our common stock and do not anticipate doing so in the foreseeable future
6. 54Natural disasters, epidemic or pandemic disease outbreaks, trade wars, armed conflicts, political unrest or other events could disrupt our business or operations or those of our development partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future
7. 55We are subject to legal proceedings, which could harm our reputation or result in other losses or unexpected expenditure of time and resources