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): December 22, 2022 (December 21, 2022)
Collegium Pharmaceutical, Inc.
(Exact name of registrant as specified in its charter)
| Virginia | | 001-37372 | | 03-0416362 |
(State or other jurisdiction of
incorporation or organization) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
| | 100 Technology Center Drive | | |
| | Suite 300 | | |
| | Stoughton, MA | 02072 | |
| | (Address of Principal Executive
Offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (781) 713-3699
Not Applicable
(Former name or former address, if changed since last report.)
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading Symbol | Name of each exchange on which
registered |
| Common Stock, $0.001 par value per share | COLL | The Nasdaq Global Select Market |
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):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate 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. ¨
| Item 7.01 | Regulation FD Disclosure. |
On December 22, 2022, Collegium Pharmaceutical, Inc. (the “Company”) issued a press release relating to the matter described in Item 8.01 of this Current Report on Form 8-K. 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.
On December 21, 2022, the Federal Circuit Court of Appeals upheld the judgment of the U.S. District Court for the District of Delaware that certain claims of the patents protecting the Company’s product Belbuca, a buprenorphine buccal film indicated for the treatment of chronic pain, are valid. In addition to upholding the District Court’s judgement regarding the validity of certain claims in the 8,147,866 patent, expiring in 2027 (the “’866 patent”), and 9,901,539 patent, expiring in 2032 (the “’539 Patent”), the Federal Circuit vacated the District Court’s findings of invalidity with respect to certain claims of the ‘866 patent and the 9,655,843 patent (both expiring in 2027) and remanded such claims for reconsideration by the District Court.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURE
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.
| | COLLEGIUM PHARMACEUTICAL, INC. |
| Dated: December 22, 2022 | | |
| | By: | /s/ Colleen Tupper |
| | | Name: Colleen Tupper |
| | | Title: Executive Vice President and Chief Financial Officer |
