Current Report Filing (8-k)
January 07 2020 - 04:06PM
Edgar (US Regulatory)
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2020-01-06
2020-01-07
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 7, 2020
COLLEGIUM PHARMACEUTICAL, INC.
(Exact name of registrant as specified
in its charter)
Virginia
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001-37372
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03-0416362
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(state or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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100 Technology Center Drive
Suite 300
Stoughton, MA
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02072
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number,
including area code: (781) 713-3699
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicated by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common stock, par value $0.001 per share
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COLL
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The NASDAQ Global Select Market
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Item 7.01
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Regulation FD Disclosure
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On January 7, 2020, Collegium Pharmaceutical, Inc. (the “Company”)
issued a press release announcing full-year revenue and operating expense guidance for 2020. 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.
To the extent that the information in this report and Exhibit
99.1 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 Exhibit 99.1, include, among others, statements regarding full-year 2020 guidance for Xtampza
ER and Nucynta Franchise revenues and total operating expense. Forward-looking statements in this report, including Exhibit 99.1,
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, 2019, 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 Exhibit
99.1, 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.
Item 9.01.
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Financial Statements and Exhibits.
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SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Collegium Pharmaceutical, Inc.
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By:
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/s/ Paul Brannelly
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Paul Brannelly
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Executive Vice President and Chief Financial Officer
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Dated: January 7, 2020
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