Cautionary Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, the anticipated impact of the novel coronavirus (“COVID-19”) pandemic on our business, business strategy, products, prospective products, product approvals, research and development costs, anticipated timing and likelihood of success of clinical trials, expected timing of the release of clinical trial data, the plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, statements about:
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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 WAKIX, 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 Société Civile de Recherche (“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 needs for additional financing; |
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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. |
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under the sections in this Annual Report on Form 10-K titled “—Item 1A. Risk Factors.” and “Part II—Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
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.
Unless otherwise indicated, information contained in this Annual Report on Form 10-K concerning our industry, including industry statistics and forecasts, competitive position and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and other third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data, and our experience in, and knowledge of, such industry and markets, which we believe to be reasonable. In addition, projections, forecasts, assumptions and estimates of the future performance of the industry in which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described herein under “—Item 1A. Risk Factors.” and “—Cautionary Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed and forecasts in the estimates made by the independent parties and by us.
You should read this Annual Report on Form 10-K and the documents that we reference in this Annual Report on Form 10-K completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
As used herein, the terms “Harmony,” “we,” “us,” “our” and “the Company” refer to Harmony Biosciences Holdings, Inc., a Delaware corporation.
Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. “Risk Factors” in this Annual Report. You should carefully consider these risks and uncertainties when investing in our securities. The principal risks and uncertainties affecting our business include the following:
Risks Related to Our Financial Condition and Capital Requirements
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We have incurred significant losses for most periods since our inception and may never achieve or maintain profitability. |
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We have only recently begun generating revenue from product sales and may never be profitable. |
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We have a limited operating history and history of commercializing drugs, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability. |
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We have only limited capital and may need to raise additional capital before we become profitable. |
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Raising additional funds by issuing securities may cause dilution to existing shareholders, raising additional funds through debt financings may involve restrictive covenants, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights to our technologies or product candidates. |
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Our auditor has previously expressed substantial doubt about our ability to continue as a going concern and we may be unable to remain a going concern. |
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We have made and we may be required to make significant payments in the future to Bioprojet under our licensing and collaboration agreements for pitolisant. |
Risks Related to Our Business
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We are substantially dependent on our ability to successfully commercialize WAKIX, which is currently our only approved product. If we are unable to successfully commercialize WAKIX, our ability to generate revenue and our financial condition will be adversely affected. |
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The commercial adoption of WAKIX and any other product candidates we develop will depend on the degree of their market acceptance. |