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- actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
- our manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes;
- our inability to obtain or delays in obtaining adequate product supply for any approved product or inability to do so at acceptable prices;
- disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent
protection for our technologies;
- significant lawsuits, including patent or stockholder litigation;
- variations in our financial results or those of companies that are perceived to be similar to us;
- changes in the structure of healthcare payment systems;
- market conditions in the pharmaceutical and biotechnology sectors;
- general economic, industry and market conditions; and
- the other factors described in this "Risk Factors" section and the risk factors included in our most recent Annual Report on Form 10-K
and Quarterly Report on Form 10-Q, which are incorporated herein by reference.
our operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any fluctuations in our
operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be
relied upon as an indication of our future performance.
the past, following periods of volatility in the market price of a company's securities, securities class-action litigation often has been instituted against that company. Such
litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert management's attention and resources, which could seriously harm our business,
financial condition, results of operations and prospects.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes are limited.
As of December 31, 2015 and 2016, we had $16.5 million and $34.6 million, respectively, of federal net operating loss
carryforwards available to offset future taxable income, which carryforwards expire at various dates through 2036. Under Section 382 and 383 of the Internal Revenue Code of 1986, as amended, or
the Code, if a corporation undergoes an "ownership change" (generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a three year period), the
corporation's ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We experienced two ownership changes
prior to January 31, 2017, and may experience additional ownership changes, including as a result of this offering. As a result, if we earn net taxable income, our ability to use our pre-change
net operating loss carryforwards to offset U.S. federal taxable income will be subject to limitations, which could potentially result in increased future tax liability to us.