CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and any accompanying prospectus supplement, including the information we incorporate by reference herein or therein, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These statements include statements about our plans, strategies, financial performance, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as “will,” “may,” “expect,” “would,” “could,” “might,” “intend,” “plan,” “believe,” “estimate,” “anticipate,” “deliver,” “seek,” “aim,” “potential,” “target,” “outlook,” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by us and our management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to:
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our commercialization efforts and strategy for WAKIX;
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the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved;
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our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications;
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our ongoing and planned clinical trials;
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our ability to expand the scope of our license agreement with Bioprojet;
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the availability of favorable insurance coverage and reimbursement for WAKIX;
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the impact of the COVID-19 pandemic;
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the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates;
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our estimates regarding expenses, future revenue, capital requirements and additional financing needs;
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our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives;
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our commercialization, marketing and manufacturing capabilities and strategy;
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significant competition in our industry;
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our intellectual property position;
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loss or retirement of key members of management;
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failure to successfully execute our growth strategy, including any delays in our planned future growth;
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our failure to maintain effective internal controls; and
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the impact of government laws and regulations.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained in this prospectus and any accompanying prospectus supplement and the documents incorporated by reference herein and therein and any free writing prospectus, whether as a result of any new information, future events, changed circumstances or otherwise.
Unless otherwise indicated, information contained in this prospectus and any accompanying prospectus supplement concerning our industry, including industry statistics and forecasts, competitive position and