Theratechnologies Inc. (TSX:TH) (NASDAQ:THER) today announced its
revised business plan which will focus on revenue growth from
tesamorelin in the short term and expenditure control.
"Our plan is to become cash neutral rapidly by focusing almost
all of our efforts and resources on maximizing revenues from
tesamorelin in the near term, while continuing to keep a cap on
expenses. By strengthening our base now, we can better assure our
success in the future and assess opportunities," said Luc Tanguay,
President and Chief Executive Officer.
Stimulating more potential revenues from tesamorelin
"Today, we have a great product approved in one major territory
and it is obvious to us that we must spend all of our energy and
focus on getting the most out of it in all territories," stated Mr.
Tanguay.
In support of EMD Serono's efforts, Theratechnologies is working
on incremental improvements to EGRIFTA(TM)'s presentation and
formulation. This includes a new single-vial presentation for which
shipping began in September, the gathering of data in support of
developing a room temperature presentation, and the development of
a more concentrated formulation to be delivered in a smaller
syringe. These improvements should provide EMD Serono with
additional tools to manage the lifecycle of EGRIFTA(TM) in the
U.S.
In an effort to capture new revenue streams from tesamorelin,
Theratechnologies will focus in the next quarters on Brazil and
Europe, the two most important potential markets after the U.S.
In Brazil, Theratechnologies will work closely with sanofi, its
commercial partner in this territory, to support them in all of
their regulatory activities. As previously announced, technical
deficiencies related to the manufacturing assessment of the Brazil
dossier have been addressed. Also, the assessment of the clinical
portion of the dossier continues to take its course.
In Europe, Theratechnologies continues to work on identifying
options to resubmit tesamorelin. Discussions with Ferrer
Internacional S.A. (Ferrer), its commercial partner in this
territory, are ongoing to ascertain the most appropriate path to
take. By year-end, Theratechnologies will have completed its
assessment of the resubmission strategy and whether the process
will be undertaken by Ferrer or un-partnered.
Second generation GRF peptide TH1173
Theratechnologies will complete the ongoing pre-clinical studies
for its second generation growth hormone-releasing peptide, TH1173,
by year-end, as previously planned.
The TH1173 clinical program will be financed internally when the
Company generates sufficient additional revenues from tesamorelin.
As it moves forward, the Company may also look to identify and
develop partnership and licensing opportunities in selected
territories to autonomously finance TH1173.
This approach will ensure that the Company can maintain adequate
liquidities to finance its near-term activities aimed at increasing
revenue potential from tesamorelin while ensuring that the clinical
development of TH1173 will be adequately financed.
Impact of action plan and measures taken
The re-alignment of Theratechnologies' priorities in the short
term has led to the suspension of most of its internal long-term
R&D activities, which will impact approximately 15 employees.
This will result in restructuring costs of $5.4 million. This
includes $2.5 million in employee compensation (inclusive of the
former CEO) and $2.9 million in non-cash items such as lease and
lab equipment write-offs. Most of these restructuring costs will be
registered in the fourth quarter of 2012.
In addition, management has agreed to forgo all performance
bonuses for 2012 and, for a second year in a row, has also agreed
to a salary freeze for the next fiscal year.
"We believe that the action plan we have adopted and the
measures we are putting in place today are in the best interests of
our company and our shareholders," stated Mr. Tanguay.
Conference Call Details
A conference call will be held today at 8:45 a.m. ET and hosted
by Luc Tanguay. The conference call will be open to questions from
financial analysts. Media and other interested individuals are
invited to participate in the call on a "listen-only" basis.
The conference call can be accessed by dialing 1-800-743-9807
(North America) or 1-416-981-9000 (International). The conference
call will also be accessible via webcast at www.theratech.com.
Audio replay of the conference call will be available until
November 13 2012, by dialing 1-800-558-5253 (North America) or
1-416-626-4100 (International) and by entering the playback code
21609750.
About Theratechnologies
Theratechnologies (TSX:TH) (NASDAQ:THER) is a specialty
pharmaceutical company that discovers and develops innovative
therapeutic peptide products, with an emphasis on growth-hormone
releasing factor peptides. Further information about
Theratechnologies is available on the Company's website at
www.theratech.com, on SEDAR at www.sedar.com and on the Securities
and Exchange Commission's website at www.sec.gov.
Forward-Looking Information
This press release contains certain statements that are
considered "forward-looking information" within the meaning of
applicable securities legislation, which statements may contain
such words as "may", "would", "could", "will", "intend", "plan",
"anticipate", "believe", "estimate", "expect" and similar
expressions. This forward-looking information includes, but is not
limited to, information regarding the capacity of the Company to
become cash-neutral, to increase its revenue in the short term, to
autonomously finance the clinical development of TH1173, to obtain
the approval of tesamorelin for the treatment of excess abdominal
fat in HIV-infected patients with lipodystrophy in territories
where applications have been filed, to develop a new presentation
and new formulation of EGRIFTA(TM) and to resubmit a marketing
authorization application for tesamorelin in Europe.
Forward-looking information is based upon a number of
assumptions and is subject to a number of risks and uncertainties,
many of which are beyond Theratechnologies' control that could
cause actual results to differ materially from those that are
disclosed in or implied by such forward-looking information. These
assumptions include, but are not limited to, the fact that we will
be able to control our costs and no unexpected expenses will have
to be incurred, our revenues from the sale of EGRIFTA(TM) in the
United States will increase, we will be able to develop a new
presentation and a new formulation of EGRIFTA(TM) and such
improvement will help managing its lifecycle, we will generate
enough revenue to finance the clinical development of TH1173 or
find a partner to do so in selected countries, regulatory
authorities in territories where marketing authorization
applications have been filed will approve tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy and, if approved, tesamorelin will be accepted by the
marketplace in these territories resulting in an increase in
revenues for the Company, we will be able to determine an
economically viable strategy to resubmit a marketing authorization
application in Europe for tesamorelin and European regulatory
authorities will approve tesamorelin for commercialization and we
will not be delayed in conducting the ongoing pre-clinical studies
for TH1173. These risks and uncertainties include, but are not
limited to, the risk that we cannot control our costs due to
unforeseen circumstances, that the revenues generated from the sale
of EGRIFTA(TM) in the United States decrease or remain stable, that
EGRIFTA(TM) is subject to a recall or is withdrawn from the market,
that regulatory authorities do not approve tesamorelin for the
treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy for commercial sale in territories where marketing
authorization applications are pending, that we are unable to
develop an economically viable strategy to resubmit a marketing
authorization application in Europe for the commercial sale of
tesamorelin and that, even if submitted in Europe, the European
authorities do not approve tesamorelin for commercial sale, that we
do not have enough revenue to pursue the development of TH1173 or
are unable to find a partner for its development, that the data
gathered do not support the development of a new presentation or
the development of a new formulation and that we are delayed in the
conduct of our ongoing pre-clinical studies for TH1173.
Theratechnologies refers potential investors to the "Risk
Factors" section of its Annual Information Form (AIF) dated
February 27, 2012. The AIF is available at www.sedar.com and at
www.sec.gov under Theratechnologies' public filings. The reader is
cautioned to consider these and other risks and uncertainties
carefully and not to put undue reliance on forward-looking
statements. Forward-looking information reflects current
expectations regarding future events and speaks only as of the date
of this press release and represents Theratechnologies'
expectations as of that date.
Theratechnologies undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise, except as may be required by applicable law.
Contacts: Roch Landriault NATIONAL Public Relations Phone:
514-843-2345
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