La Jolla Pharmaceutical (LJPC)

Risks

• The commercial success of GIAPREZA and XERAVA will depend on our ability to obtain an uninterrupted supply of GIAPREZA and XERAVA from our contract manufacturers.
• Product liability or other lawsuits against us could cause us to incur substantial liabilities and reduce GIAPREZA and XERAVA sales.
• Our ability to continue commercializing GIAPREZA is dependent on our fulfillment of contractual obligations under the royalty financing agreement with HealthCare Royalty Partners.
• The commercial success of GIAPREZA and XERAVA in certain ex-U.S. territories is dependent on the fulfillment of contractual obligations under the Company’s out-license agreements.
• Our overall financial performance, including but not limited to, net product sales and net cash used for or provided by operating activities, may not meet our expectations.
• Our capital requirements and our potential need for, and ability to obtain, additional financing are uncertain.
• Future utilization of net operating loss carryforwards or research and development credit carryforwards may be impaired due to changes in ownership.
• Our ability to hire and retain key employees is uncertain.
• Our employees may engage in misconduct, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
• Failure to obtain regulatory approval in international jurisdictions would prevent our products, our product candidates or any other products the Company or its current or future out-licensees may develop from being marketed abroad.
• We may not be successful in our efforts to out-license our product candidates.
• GIAPREZA’s and XERAVA’s market exclusivity periods will depend on the validity and enforceability of issued and pending patents covering GIAPREZA and XERAVA.
• If we fail to comply with our obligations under our in-license agreements, we may lose rights to critical patents that are important to the commercialization and net sales potential of GIAPREZA and XERAVA.
• If our products or our product candidates infringe the rights of others, we could be subject to expensive litigation, become liable for substantial damages, be required to obtain licenses from others or be prohibited from selling our products or product candidates altogether.
• Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
• We are subject to various federal, state and foreign laws and regulations governing the health care industry that could result in substantial penalties for noncompliance.
• Drugs approved by the FDA, EC and/or other regulatory agencies are subject to ongoing regulation.
• Business interruptions resulting from geopolitical actions, natural disasters, public health crises or other catastrophic events could have an adverse impact on our business.
• The price per share of our common stock may fluctuate significantly, and you may lose all or part of your investment.
• We have never paid a dividend on shares of our common stock, and you should rely on price appreciation of shares of our common stock for return on your investment.
• Conversion of our convertible preferred stock would result in substantial dilution for our existing common stockholders.
• Our directors, executive officers and principal stockholders have substantial control over the Company, which could limit your ability to influence the outcome of key transactions, including a change of control.
• Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.