Item 7.01 Regulation FD Disclosure.
On
In addition, on
To the extent that the information in this Current Report on Form 8-K, including
Exhibits 99.1 and 99.2 furnished herewith, are not descriptions of historical
facts regarding the Company, they are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. The Company
may, in some cases, use terms such as "predicts," "forecasts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "should" or other words that convey
uncertainty of future events or outcomes to identify these forward-looking
statements. Examples of forward-looking statements contained in this Current
Report on Form 8-K, including Exhibits 99.1 and 99.2 furnished herewith,
include, among others, statements related to the Company's full-year 2023
financial guidance, including projected product revenue, adjusted operating
expenses and adjusted EBITDA, current and future market opportunities for its
products and the Company's assumptions related thereto, expectations (financial
or otherwise) and intentions, and other statements that are not historical
facts. Such statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results, performance, or
achievements to differ materially from the Company's current expectations.
Actual results may differ materially from management's expectations and such
forward-looking statements in this Current Report on Form 8-K, including
Exhibits 99.1 and 99.2 furnished herewith, could be affected as a result of
various important factors, including risks relating to, among others: risks
related to the ability to realize the anticipated benefits of the Company's
acquisitions at all or within the expected time period; unknown liabilities;
risks related to future opportunities and plans for the Company's products,
including uncertainty of the expected financial performance of such products;
the impact of the COVID-19 pandemic on the Company's ability to conduct its
business, reach its customers, and supply the market with its products; its
ability to commercialize and grow sales of its products; its ability to manage
its relationships with licensors; the success of competing products that are or
become available; the Company's ability to obtain and maintain regulatory
approval of its products and any product candidates, and any related
restrictions, limitations, and/or warnings in the label of an approved product;
the size of the markets for the Company's products and product candidates, and
the Company's ability to service those markets; the Company's ability to obtain
reimbursement and third-party payor contracts for its products; the rate and
degree of market acceptance of the Company's products and product candidates;
the costs of commercialization activities, including marketing, sales and
distribution; changing market conditions for the Company's products; the outcome
of any patent infringement or other litigation that may be brought by or against
the Company; the outcome of any governmental investigation related to the
Company's business; the Company's ability to secure adequate supplies of active
pharmaceutical ingredient for each of its products and manufacture adequate
supplies of commercially saleable inventory; the Company's ability to obtain
funding for its operations and business development; regulatory developments in
the
Item 8.01 Other Information.
On
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release, datedJanuary 4, 2023 . 99.2 Corporate Presentation, datedJanuary 4, 2023 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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