| Item 7.01 |
Regulation FD Disclosure. |
On January 4, 2023, Collegium Pharmaceutical, Inc. (the “Company”)
issued a press release announcing full-year revenue, adjusted operating expense and adjusted EBITDA guidance for 2023. The Company also
announced that the Board of Directors of the Company authorized a new share repurchase program for 2023 to repurchase up to $100 million
of the Company’s shares of common stock, which program is described in more detail under Item 8.01 of this Current Report on Form 8-K.
A copy of the press release is attached hereto as Exhibit 99.1 and is being furnished, not filed, under Item 7.01 of this Current
Report on Form 8-K.
In addition, on January 4, 2023, the Company posted
a corporate presentation to its website that representatives of the Company may use from time to time in presentations or discussions
with investors, analysts or other parties. A copy of the presentation is attached hereto as Exhibit 99.2 and is being furnished,
not filed, under Item 7.01 of this Current Report on Form 8-K.
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 U.S.; the Company’s expectations
regarding its ability to obtain and maintain sufficient intellectual property protection for its products; the Company’s ability
to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S.
Drug Enforcement Agency compliance; the Company’s customer concentration; and the accuracy of the Company’s estimates regarding
expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk
Factors" in the Company’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the Securities
and Exchange Committee. Any forward-looking statements that the Company makes in this Current Report on Form 8-K, including Exhibits
99.1 and 99.2 furnished herewith, speak only as of the date of this Current Report on Form 8-K. The Company assumes no obligation
to update any forward-looking statements whether as a result of new information, future events or otherwise, after the date of this Current
Report on Form 8-K.