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Financial report summary
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Gene Biotherapeutics • Spectrum Pharmaceuticals • Aceragen • Lineage Cell Therapeutics • Exelixis • Aradigm • Cymabay Therapeutics • Inovio Pharmaceuticals • Viracta Therapeutics • Arena PharmaceuticalsRisks
- Certain of our products subject us to additional or heightened risks.
- Our success depends on developing and commercializing new products or expanding the indications for existing products.
- We face challenges in accurately forecasting sales because of the difficulties in predicting demand for our products and fluctuations in purchasing patterns or wholesaler inventories.
- We face significant competition from global pharmaceutical and biotechnology companies, specialized pharmaceutical firms and generic drug manufacturers.
- Our existing products are subject to reimbursement pressures from government agencies and other third parties, required rebates and discounts, and other pricing pressures.
- We may experience adverse impacts resulting from the importation of our products from lower price markets or the distribution of illegally diverted or counterfeit versions of our products.
- We face risks in our clinical trials, including the potential for unfavorable results, delays in anticipated timelines and disruption.
- We may face manufacturing difficulties, delays or interruptions, including at our third-party manufacturers and corporate partners.
- Our operations depend on compliance with complex FDA and comparable international regulations. Failure to obtain broad approvals on a timely basis or to maintain compliance could delay or halt commercialization of our products.
- We are impacted by evolving laws, regulations and legislative or regulatory actions applicable to the healthcare industry.
- We are subject to risks if significant safety issues arise for our marketed products or our product candidates.
- Our success depends to a significant degree on our ability to obtain and defend our patents and other intellectual property rights both domestically and internationally, and to operate without infringing upon the patents or other proprietary rights of third parties.
- We face potentially significant liability and increased expenses from litigation and government investigations relating to our products and operations.
- Our business has been, and may in the future be, adversely affected by outbreaks of epidemic, pandemic or contagious diseases.
- We face risks associated with our global operations.
- Climate change and related natural disasters, as well as legal, regulatory, or market measures to address climate change, can negatively affect our business and operations.
- Our aspirations, goals and disclosures related to environmental, social and governance (“ESG”) matters expose us to numerous risks, including risks to our reputation and stock price.
- We depend on relationships with third parties for sales and marketing performance, technology, development, logistics and commercialization of products. Failure to maintain these relationships, poor performance by these companies or disputes with these third parties could negatively impact our business.
- Due to the specialized and technical nature of our business, the failure to attract, develop and retain highly qualified personnel could adversely impact us.
- The failure to successfully implement or upgrade enterprise resource planning and other information systems could adversely impact our business and results of operations.
- Information system service interruptions or breaches, including significant cybersecurity incidents, could give rise to legal liability and regulatory action under data protection and privacy laws and adversely affect our business and operations.
- We are subject to risks associated with engaging in business acquisitions, licensing arrangements, collaborations, options, equity investments, asset divestitures and other strategic transactions.
- Changes in our effective income tax rate could reduce our earnings.
Management Discussion
- See Note 2. Revenues of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for further disaggregation of revenue by product.
- (1) Represents our revenue from cobicistat (“C”), emtricitabine (“FTC”) and tenofovir alafenamide (“TAF”) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company (“Janssen”). See Note 7. Collaborations and Other Arrangements of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information.
- (2) Includes Atripla, Emtriva, Sunlenca and Tybost.