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Item 7.01
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Regulation FD Disclosure
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On January 7, 2019, Collegium Pharmaceutical, Inc. (the “Company”) issued a press release announcing full-year revenue and operating expense guidance for 2019. In connection with this announcement, and in meetings with investors at the 37
th
Annual J.P. Morgan Healthcare Conference in San Francisco, California, the Company expects to utilize a presentation containing a general business update, including its full-year revenue and operating expense guidance for 2019. A copy of the press release and the corporate presentation are attached hereto as Exhibits 99.1 and 99.2, respectively, and each 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 report, including Exhibits 99.1 and 99.2, 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. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this report, including Exhibits 99.1 and 99.2, include, among others, statements regarding full-year 2019 guidance for Xtampza ER and Nucynta Franchise revenues and total operating expense, current and future market opportunities for our products and our assumptions related thereto, and the details of our key near-term value drivers. Forward-looking statements in this report, including Exhibits 99.1 and 99.2, involve substantial risks and uncertainties that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the following: our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of an approved product; our plans to commercialize and grow sales of our products; our ability to effectively commercialize in-licensed products and manage our relationships with licensors; the success of competing products that are or become available; our ability to obtain and maintain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us, including litigation with Purdue Pharma, L.P. and Teva Pharmaceuticals USA, Inc.; regulatory developments impacting our products and market; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products and product candidates; our ability to operate our business without infringing the intellectual property rights of others; the performance of our third-party suppliers and manufacturers; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products; our ability to comply with stringent government regulations relating to the manufacturing and marketing of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; the loss of key scientific or management personnel; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks, uncertainties and factors are described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, and those risks described from time to time in other reports which we file with the SEC. Any forward-looking statements that we make in this report, including Exhibits 99.1 and 99.2, speak only as of the date of this report. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this report.