UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
May 27, 2014
Commission File Number 001-35203
THERATECHNOLOGIES INC.
(Translation of registrant’s name into English)
2310 Alfred-Nobel Boulevard
Montréal, Québec, Canada
H4S 2B4
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Yes ¨ No x
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.
THERATECHNOLOGIES INC.
| Exhibit |
Description | |
| 99.1 | Material Change Report dated May 27, 2014 | |
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, thereunto duly authorized.
| THERATECHNOLOGIES INC. | ||
| By: | /s/ Jocelyn Lafond | |
| Name: Jocelyn Lafond | ||
| Title: Vice President, Legal Affairs | ||
Date: May 27, 2014
Exhibit 99.1
MATERIAL CHANGE REPORT
Regulation 51-102 Respecting Continuous Disclosure Obligations
Form 51-102F3
ITEM 1 – NAME AND ADDRESS OF COMPANY
THERATECHNOLOGIES INC.
2310 Alfred-Nobel Boulevard
Montreal, Québec
Canada H4S 2B4
ITEM 2 – DATE OF MATERIAL CHANGE
May 20, 2014
ITEM 3 – NEWS RELEASE
A news release describing this material change was issued on May 20, 2014 on “Marketwire”. A copy of the news release is available on the SEDAR website at www.sedar.com.
ITEM 4 – SUMMARY OF MATERIAL CHANGE
On May 20, 2014, Theratechnologies Inc. (the “Corporation”) announced that it will be releasing additional limited supplies of the 2 mg/vial presentation of EGRIFTATM (tesamorelin for injection) in the early part of June.
The Corporation also announced that it continues with its plan to use the initial 1 mg/vial presentation, which was available in the first two years of marketing the product. Required documentation for the 1mg/vial presentation has been filed with the United States Food and Drug Administration (the “FDA”). The pre-production phase of the 1mg/vial has already started and the 1 mg/vial will be released later in the fall.
ITEM 5 – FULL DESCRIPTION OF MATERIAL CHANGE
5.1 Full description of material change
On May 20 2014, the Corporation announced that it will be releasing additional limited supplies of the 2 mg/vial presentation of EGRIFTATM (tesamorelin for injection) in the early part of June. This comes as a result of on-going communications with the FDA and a Corporation determination that there is a critical need to maintain the supply for existing patient use. This will allow the Corporation to help patients stay on therapy during the production stoppage.
The Corporation also announced that it continues with its plan to use the initial 1 mg/vial presentation, which was available in the first two years of marketing the product. Required documentation for the 1mg/vial presentation has been filed with the FDA. The pre-production phase of the 1mg/vial has already started and the 1 mg/vial will be released later in the fall. In the meantime, the distribution of the 2 mg/vial will be managed in collaboration with healthcare professionals and network of specialty pharmacies to allow current patients to continue receiving treatment until a steady supply of the 1 mg/vial is in place.
5.2 Disclosure for restructuring transactions
Not applicable.
ITEM 6 – RELIANCE ON SUBSECTION 7.1(2) OR (3) OF NATIONAL INSTRUMENT 51-102
Not applicable.
ITEM 7 – OMITTED INFORMATION
Not applicable.
ITEM 8 – EXECUTIVE OFFICER
For further information, contact Jocelyn Lafond, Vice President, Legal Affairs, and Corporate Secretary of the Corporation at (514) 336-4804, ext. 288.
ITEM 9 – DATE OF REPORT
May 27, 2014.
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