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New words:
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Financial report summary
?Competition
Gilead Sciences • Cymabay Therapeutics • United Therapeutics • Sanofi • Intercept Pharmaceuticals • Reata Pharmaceuticals • Protagonist Therapeutics • Malachite Innovations • Abbvie • Morphic HoldingRisks
- Item 1A. Risk Factors.
- Failure to complete, or delays in completing, the pending transaction with Pfizer announced on December 13, 2021 could materially and adversely affect our results of operations and our stock price.
- Lawsuits have been filed against us and the members of our board of directors arising out of the pending transaction, and additional such lawsuits may be filed in the future, which may delay or prevent the pending transaction.
- The ability to complete the transaction is subject to the receipt of consents and approvals from government entities, which may impose conditions that could have an adverse effect or could cause either party to abandon the transaction.
- The Merger Agreement with Pfizer limits our ability to pursue alternative transactions which could deter a third party from proposing an alternative transaction.
- Drug development programs are expensive, time consuming, uncertain and susceptible to change, interruption, delay or termination.
- We will need to obtain additional funds or enter into collaboration agreements to execute on our corporate strategy, and we may not be able to do so at all or on terms you view as favorable; your ownership may be substantially diluted if we do obtain additional funds; you may not agree with the manner in which we allocate our available resources; and we may not be profitable.
- Our business may be negatively impacted based on the clinical trials and preclinical studies of, and decisions affecting, one or more of our drug candidates.
- The development, approval or commercialization of any of our drug candidates could be negatively affected by circumstances related to other drug candidates or approved products.
- Topline data may not accurately reflect the complete results of a particular study or trial.
- Our hypothesis that selectively targeting receptors can lead to more efficacious or safer drugs may not be correct.
- The results of preclinical studies and completed clinical trials are not necessarily predictive of future results, and our current drug candidates or any approved drugs may not be further developed or have favorable results in later studies or trials.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
- Drug discovery and development is intensely competitive in the therapeutic areas on which we focus. If the number of our competitors increase or they develop treatments that are approved faster, marketed better, less expensive, or demonstrated to be more effective or safer than our drugs or drug candidates, our commercial opportunities could be reduced or eliminated.
- Our revenues in the future will be substantially dependent on the success of our or our collaborators’ and licensees’ marketing of drugs we have discovered or developed. To the extent such drugs are not commercially successful, our business, financial condition, and results of operations may be materially adversely affected, and the price of our common stock may decline.
- Our drugs may not be commercially successful if not widely covered and adequately reimbursed by third-party payers, and we may depend on others to obtain and maintain third-party payer access; inadequate third-party coverage and reimbursement could make entering into agreements with pharmaceutical companies to collaborate or commercialize our drugs more difficult and diminish our revenues.
- Certain Governments outside of the United States impose strict price controls, which may adversely affect our revenues, if any.
- Forecasting potential sales for drugs will be difficult, and if our projections are inaccurate, our business and stock price may be adversely affected.
- Our efforts will be seriously jeopardized if we are unable to attract and retain key and other employees.
- We are expanding our organization and may experience difficulties in managing this growth, which could disrupt our operations.
- Data generated or analyzed with respect to product use in the market or required postmarketing or other studies or trials may result in decreased demand, lower sales, product recall, regulatory action, or litigation.
- If we license or otherwise partner our drugs, our failure to maintain such agreements or poor performance or results under such agreements could negatively impact our business.
- We rely on other companies, including third-party manufacturers and sole-source suppliers, to manufacture all our drugs and drug candidates, and we or such other companies may encounter failures or difficulties or not receive or provide adequate supply, which could adversely affect development or commercialization.
- Our drug candidates are subject to extensive regulation, and we may not receive required regulatory approvals, or timely approvals, for any of our drug candidates.
- Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, Orphan Drug, or similar designations by the FDA or other applicable regulatory agencies may not lead to a faster development or review process or other intended benefits of such designation.
- Our activities and drugs will still be subject to extensive postmarketing regulation if approved.
- Our ability to generate revenues from any of our drugs that receive regulatory approval will be subject to a variety of risks, many of which are out of our control.
- Collaboration and license agreement relationships may lead to disputes, divert management’s attention, expose us to liability, and delay drug development and commercialization, and we may not realize the full commercial potential of our drug candidates or drugs.
- Setbacks, consolidation, and regulation in the pharmaceutical and biotechnology industries could make entering into agreements with pharmaceutical companies, including agreements to collaborate or commercialize our drugs more difficult.
- We and our collaborators rely on third parties to conduct clinical trials and preclinical studies. If those parties do not comply with regulatory and contractual requirements, successfully carry out their contractual obligations, or meet expected deadlines, our drug candidates may not advance in a timely manner or at all.
- We may participate in new strategic transactions that could impact our liquidity, increase our expenses, present significant distractions to our management, and be viewed as unfavorable.
- We may incur substantial liabilities for any product liability claims or otherwise as a drug product developer.
- We have significant contractual obligations that may adversely affect our cash flow, cash position, and stock price.
- We may be subject, directly or indirectly, to federal, state, and foreign healthcare laws and regulations, including but not limited to fraud and abuse and false claims laws as well as data privacy and data protection. If we are unable to comply, or have not fully complied, with such laws or regulations, we could face substantial penalties and prosecution.
- We may be subject to evolving laws, regulations, rules, contracts and other obligations regarding data privacy and protection, and our actual or perceived failure to comply with such obligations could harm our reputation, subject us to government enforcement actions or private litigation (that could carry potentially significant fines or penalties for non-compliance), disrupt our clinical trials or commercialization of products, or other adverse effects on our business or prospects.
- We may not be able to effectively integrate, manage or maintain our international operations, and such difficulty could adversely affect our business operations, financial condition, results of operations and stock price.
- We and third parties we contract with use hazardous materials in our operations.
- If our information technology or data is compromised by catastrophic events, security breaches, including any cybersecurity incidents, or otherwise, our business and operations might be disrupted or adversely affected.
- We and our employees and directors may be named as defendants in litigation that could result in substantial costs and divert management’s attention.
- Negative US and global economic conditions may pose challenges to our business strategy, which relies on funding from collaborators or the financial markets, and may create other financial risks for us.
- Currency fluctuations may negatively affect our financial condition.
- Our ability to use our net operating losses and certain other tax attributes to offset future taxable income or taxes may be limited.
- Our success is dependent on intellectual property rights held by us and third parties and our interest in these rights is complex and uncertain.
- A dispute regarding the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be costly and result in delays or termination of our future research, development, manufacturing, and sales activities.
- We cannot protect our intellectual property rights throughout the world.
- Our stock price will likely be volatile, and your investment in our stock could decline in value.
- Any future equity or debt issuances or other financing transactions may have dilutive or adverse effects on our existing stockholders.
- There are a substantial number of shares of our common stock that may become eligible for future sale in the public market, and the sale of our common stock could cause the market price of our common stock to fall.
- Our executive officers and directors, and other holders of our common stock and other securities, may take actions that are contrary to your interests, including selling their stock.
- Certain of our agreements, provisions in our charter documents, possible future agreements and Delaware law could delay or prevent a change in management or a takeover attempt that you may consider to be in your best interests.
- Laws, rules, and regulations, including relating to public companies, may be costly and impact our ability to attract and retain directors and executive officers.
- Changes in funding for the FDA, the SEC, and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
- The withdrawal of the United Kingdom from the European Union, commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the European Union, result in restrictions or imposition of taxes and duties for importing our product candidates into the European Union, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the European Union.
- Our employees, clinical trial investigators, CROs, CMOs, consultants, vendors, and collaborators may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Our disclosure controls and procedures and our internal control over financial reporting may not prevent potential errors and fraud.
- Current and future tax laws and regulations could adversely affect our business and financial condition.
- Changes or modifications in financial accounting standards, including those related to revenue recognition, may harm our results of operations.
Management Discussion
- We recognized revenues of $0.1 million for the year ended December 31, 2021, compared to revenues of $0.3 million for the year ended December 31, 2020. Absent any new collaborations, we expect our 2022 revenues will primarily consist of potential milestone payments from our existing collaborations and license agreements.
- Revenues from milestones and royalties are difficult to predict, and our overall revenues will likely continue to vary from quarter to quarter and year to year. In the short term, we expect the amount of revenue we earn to fluctuate.
- Research and development expenses, which account for the majority of our expenses, consist primarily of clinical trial costs (including payments to contract research organizations, or CROs), salaries and other personnel costs, preclinical study fees, manufacturing costs for non-commercial products, research supply costs and facility and equipment costs. We expense research and development costs as they are incurred when these expenditures have no alternative future uses. We generally do not track our earlier-stage, internal research and development expenses by project; rather, we track such expenses by the type of cost incurred.