What the changes say
- Merger integration risks regarding Astria and its product candidate navenibart dominate the newly added disclosures.
- New disclosures address the path to sustained profitability after achieving first annual net income in 2025.
- Risks related to generic and biosimilar competition are expanded.
What changed since the prior 10-K
New
- NewFinancial and Liquidity Risks
We may not achieve sustained profitability
Although we achieved net income on a U.S. GAAP basis for 2025, we have not yet achieved sustained profitability.
- NewFinancial and Liquidity Risks
We may need to raise additional capital or obtain additional financing in the future. If we are unable to raise capital or obtain additional financing if and when needed, we may need to adjust our operations
We may need to raise additional capital or obtain additional financing to fund future operations and commercialization.
- NewRisks Relating to the Merger
If the benefits of the Merger do not meet the expectations of investors or securities analysts, the market price of our common stock may decline
The market price of our common stock may decline if the benefits of the Merger do not meet analyst expectations.
- NewRisks Relating to the Merger
Combining Astria with our business may be more difficult, costly or time consuming than expected and the combined company may fail to realize the anticipated benefits and synergies of the Merger
Combining Astria with our business may be more difficult or costly than expected, risking anticipated synergies.
- NewRisks Relating to the Merger
An inability to realize the full extent of the anticipated benefits of the Merger, as well as any delays encountered in the integration process, could have an adverse effect on the revenues, levels of expenses and operating results of the combined company, which may adversely affect the value of our common stock
Integration delays or loss of key employees from the Merger could harm our operating results and stock value.
- NewRisks Relating to the Merger
We are in the early stages of integrating Astria into our business, and unknown or unanticipated risks associated with Astria’s business or product candidates could adversely affect us
Unknown risks associated with Astria or its product candidate navenibart could adversely affect us despite due diligence.
- NewRisks Relating to the Merger
We will likely incur substantial expenses related to the Merger
We will likely incur substantial expenses related to completing the Merger and combining operations.
- NewRisks Relating to the Merger
Issuance of shares of our common stock in connection with the Merger may adversely affect the market price of our common stock
Issuing 17.5% more shares of our common stock for the Merger may cause stock price fluctuations or decreases.
- NewRisks Relating to Product Development and Commercialization
manage our pipeline or integrate viable products or product candidates into our business on acceptable terms, or at all, our business and product development efforts could suffer
Our drug development and clinical trials are complex, uncertain, and susceptible to failure at any stage.
- NewRisks Relating to Product Development and Commercialization
reference to all of the nonclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. Manufacturers may seek to launch generic drugs following the expiration of the marketing exclusivity period, even if we still have patent protection for such drugs
Generic drug manufacturers may launch competing products following exclusivity expiration despite active patent protection.
- NewRisks Relating to Product Development and Commercialization
We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our biological products and product candidates
We may face competition from biosimilars under the BPCIA framework once reference periods expire.
- NewRisks Relating to Product Development and Commercialization
with us, potential revenues from commercialization of our products and product candidates could be reduced, delayed or eliminated
Commercialization depends on our direct efforts or collaborative arrangements, such as those with Torii, Neopharmed, Shionogi, Green Cross, Clearside, and Kaken.
- NewRisks Relating to Product Development and Commercialization
to incur significant costs and potential delays in finding new third-party vendors, which could adversely impact the development and commercialization timeframes for our products and product candidates
- NewRisks Relating to Contractual Arrangements
Agreement (e.g., upon certain asset sales, a change of control of the Company and specified other events, subject to certain exceptions), all or part of the then-outstanding term loans under the Blackstone Loan Agreement, in each case, subject to certain exceptions as set forth in the Blackstone Loan Agreement
- NewRisks Relating to Technology
healthcare system upon which our business relies could adversely affect our business if such disruption is widespread and continues for an extended period of time
- NewOther Operational Risks
Our ability to maintain global brand uniformity for ORLADEYO may be impacted by the sale of our European ORLADEYO business
Dropped
- DroppedFinancial and Liquidity Risks
We have incurred losses since our inception and may never achieve sustained profitability
Incurred losses since inception and may never achieve sustained profitability.
- DroppedFinancial and Liquidity Risks
We 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
Sustained operating losses and expectation of continued operating losses.
- DroppedFinancial and Liquidity Risks
to 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
Liquidity needs determined by commercial success of ORLADEYO and budget plans.
- DroppedRisks Relating to Drug Development and Commercialization
to comply with regulatory requirements and industry standards or meet contractual obligations in a timely manner or at all; and
- DroppedRisks Relating to Drug Development and Commercialization
If 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
Impact of global health pandemics like COVID-19 on clinical trials.
- DroppedRisks Relating to Drug Development and Commercialization
following 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
- DroppedLegal and Regulatory Risks
kickback, 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
Failure to obtain additional financing or partnership arrangements.
- DroppedRisks Relating to International Operations
The 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
Reworded
- 94% rewrittenRisks Relating to Product Development and Commercialization
Our success depends in part 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
Streamlined pipeline management and in-licensing risk factor text.
Was: Our 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
- 83% rewrittenRisks Relating to Product Development and Commercialization
We have expanded our development and regulatory capabilities and implemented sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
Removed mention of management team's limited experience and added specific risk of management resource diversion.
Was: We 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
- 78% rewrittenLegal and Regulatory Risks
We 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
Added specific mention of presidential administration changes impacting product pricing, revenues, and supply chains.
- 77% rewrittenRisks Relating to Contractual Arrangements
We may face risks related to our former U.S. Government contracts
Replaced active BARDA/NIAID contract risks for galidesivir with residual close-out risks from former U.S. Government contracts.
Was: We face risks related to our U.S. Government contracts, which may create a disadvantage and additional risks to us
- 73% rewrittenLegal and Regulatory Risks
We 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
Added the HHS Office of Inspector General to the list of regulatory and law enforcement authorities.
- 68% rewrittenRisks Relating to Technology
Cyber incidents and related disruptions in our or our third-party vendors’ information technology systems could adversely affect our business
Updated regulatory authorities to include general U.S. and foreign regulators alongside the FDA for IT systems.
- 67% rewrittenRisks Relating to Product Development and Commercialization
The 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
Retained core side effect and efficacy risks with minor formatting updates.
- 54% rewrittenRisks Relating to Competing in Our Industry
Developments by others may render our products, product candidates, or technologies obsolete or noncompetitive
Updated with December 2025 FDA approval of oral pellet formulation of ORLADEYO for pediatric patients aged 2 to less than 12.
- 46% rewrittenRisks Relating to Contractual Arrangements
If 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
- 39% rewrittenRisks Relating to Contractual Arrangements
The covenants contained in the Blackstone 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 Blackstone Loan Agreement
Was: The 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
- 39% rewrittenRisks Relating to International Operations
Foreign currency exchange rate fluctuations could have an adverse impact on our results of operations, financial position, and cash flows
- 38% rewrittenOther Operational Risks
If 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 growth of our business may be delayed or stopped
Was: If 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
- 34% rewrittenRisks Relating to Investing in Our Common Stock
Future sales and issuances of securities may dilute the ownership interests of our current stockholders and cause our stock price to decline
- 25% rewrittenLegal and Regulatory Risks
We 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 commercialize our products or develop our product candidates
Was: We 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
- 25% rewrittenRisks Relating to Product Development and Commercialization
We 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
- 22% rewrittenRisks Relating to International Operations
Our actual or perceived failure to comply with European or other international governmental laws and regulations and other legal obligations related to privacy, data protection and information security could harm our business
Was: Our 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
- 20% rewrittenOther Operational Risks
If our risk management committee and other compliance methods are not effective, our business, financial condition and operating results may be adversely affected
All 63 risk factors
Headings as the filing states them, in filing order.
Financial and Liquidity Risks
- 01We may not achieve sustained profitabilityNew
- 02We may need to raise additional capital or obtain additional financing in the future. If we are unable to raise capital or obtain additional financing if and when needed, we may need to adjust our operationsNew
Risks Relating to the Merger
- 03If the benefits of the Merger do not meet the expectations of investors or securities analysts, the market price of our common stock may declineNew
- 04Combining Astria with our business may be more difficult, costly or time consuming than expected and the combined company may fail to realize the anticipated benefits and synergies of the MergerNew
- 05An inability to realize the full extent of the anticipated benefits of the Merger, as well as any delays encountered in the integration process, could have an adverse effect on the revenues, levels of expenses and operating results of the combined company, which may adversely affect the value of our common stockNew
- 06We are in the early stages of integrating Astria into our business, and unknown or unanticipated risks associated with Astria’s business or product candidates could adversely affect usNew
- 07We will likely incur substantial expenses related to the MergerNew
- 08Issuance of shares of our common stock in connection with the Merger may adversely affect the market price of our common stockNew
Risks Relating to Product Development and Commercialization
- 09Our success depends in part 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 candidates94% rewritten
- 10manage our pipeline or integrate viable products or product candidates into our business on acceptable terms, or at all, our business and product development efforts could sufferNew
- 11If 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
- 12If 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
- 13We 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 small25% rewritten
- 14reference to all of the nonclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. Manufacturers may seek to launch generic drugs following the expiration of the marketing exclusivity period, even if we still have patent protection for such drugsNew
- 15We may face competition from biosimilars, which may have a material adverse impact on the future commercial prospects of our biological products and product candidatesNew
- 16The 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 community67% rewritten
- 17with us, potential revenues from commercialization of our products and product candidates could be reduced, delayed or eliminatedNew
- 18The results of our partnership with Torii may not meet our current expectations
- 19There 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
- 20We have expanded our development and regulatory capabilities and implemented sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations83% rewritten
- 21to incur significant costs and potential delays in finding new third-party vendors, which could adversely impact the development and commercialization timeframes for our products and product candidatesNew
- 22Commercialization 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
- 23We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced
- 24Developments by others may render our products, product candidates, or technologies obsolete or noncompetitive54% rewritten
- 25If 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
- 26We 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 penalties73% rewritten
- 27We 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 abroad78% rewritten
- 28Our 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
- 29We 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 commercialize our products or develop our product candidates25% rewritten
- 30We 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
- 31If, 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
- 32If 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
- 33We 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
- 34We have diversified our pipeline to include the development of protein therapeutics, which may create additional risks and challenges
- 35Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
- 36We 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
- 37We 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
- 38We may face risks related to our former U.S. Government contracts77% rewritten
- 39If 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 remedies46% rewritten
- 40Agreement (e.g., upon certain asset sales, a change of control of the Company and specified other events, subject to certain exceptions), all or part of the then-outstanding term loans under the Blackstone Loan Agreement, in each case, subject to certain exceptions as set forth in the Blackstone Loan AgreementNew
- 41The covenants contained in the Blackstone 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 Blackstone Loan Agreement39% rewritten
Risks Relating to International Operations
- 42International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, and economic risks
- 43Any of these factors could significantly harm our international expansion of operations and adversely affect our business and results of operations
- 44Foreign currency exchange rate fluctuations could have an adverse impact on our results of operations, financial position, and cash flows39% rewritten
- 45Our actual or perceived failure to comply with European or other international governmental laws and regulations and other legal obligations related to privacy, data protection and information security could harm our business22% rewritten
Risks Relating to Technology
- 46If 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
- 47Cyber incidents and related disruptions in our or our third-party vendors’ information technology systems could adversely affect our business68% rewritten
- 48healthcare system upon which our business relies could adversely affect our business if such disruption is widespread and continues for an extended period of timeNew
- 49We 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
- 50From 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
- 51Our ability to maintain global brand uniformity for ORLADEYO may be impacted by the sale of our European ORLADEYO businessNew
- 52Our 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
- 53Insurance coverage is increasingly more costly and difficult to obtain or maintain
- 54If 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 growth of our business may be delayed or stopped38% rewritten
- 55If our risk management committee and other compliance methods are not effective, our business, financial condition and operating results may be adversely affected20% rewritten
- 56Our 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
- 57Our 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
- 58Our 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
- 59Future sales and issuances of securities may dilute the ownership interests of our current stockholders and cause our stock price to decline34% rewritten
- 60We have anti-takeover provisions in our corporate charter documents that may result in outcomes with which you do not agree
- 61We have never paid dividends on our common stock and do not anticipate doing so in the foreseeable future
- 62Natural 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
- 63We are subject to legal proceedings, which could harm our reputation or result in other losses or unexpected expenditure of time and resources
Other Biocryst Pharmaceuticals 10-Ks
- FY2024 10-K risk factors55 risks
Operating losses and capital needs dominate the risk profile, alongside commercialization hurdles for ORLADEYO and RAPIVAB.
Filed Feb 25, 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.