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6-K Filing
Theratechnologies (THTX) 6-KCurrent report (foreign)
Filed: 24 Feb 14, 12:00am
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
February 14, 2014
ITEM 3 – NEWS RELEASE
A news release describing this material change was issued on February 14, 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 February 14, 2014, Theratechnologies Inc. (the “Corporation”) announced that it expected current inventory ofEGRIFTA® (tesamorelin for injection) to be depleted in the coming weeks due to a combination of manufacturing delays and issues observed during the production of new batches ofEGRIFTA®. The depletion of the inventory will result in a shortage ofEGRIFTA® and an eventual stock-out.
The Corporation also announced that it made the decision to temporarily cease the manufacture ofEGRIFTA®.
ITEM 5 – FULL DESCRIPTION OF MATERIAL CHANGE
5.1 Full description of material change
On February 14, 2014, the Corporation announced that it expected current inventory ofEGRIFTA® (tesamorelin for injection) to be depleted in the coming weeks due to a combination of manufacturing delays and issues observed during the production of new batches ofEGRIFTA®. The depletion of the inventory will result in a shortage ofEGRIFTA® and an eventual stock-out. EMD Serono, Inc. has notified the United States Food and Drug Administration about this product shortage.
The Corporation also announced that it made the decision to temporarily cease the manufacture ofEGRIFTA® and was unable to determine a timeline to resume the manufacture and delivery ofEGRIFTA®. The Corporation is currently investigating the causes of the issues observed. The Corporation will update the market when new information is available.
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The transaction with EMD Serono, Inc. previously announced on December 13, 2013 relating to the Corporation regaining all rights toEGRIFTA® in the United States is still expected to close during the Corporation’s second quarter of its current fiscal year despite the decision made by the Corporation to temporarily halt the manufacture ofEGRIFTA®.
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
February 24, 2014.