MONTREAL, April 27,
2022 /CNW Telbec/ - Theratechnologies Inc.
(Theratechnologies or Company) (TSX: TH) (NASDAQ: THTX), a
biopharmaceutical company focused on the development and
commercialization of innovative therapies, today announced that it
will focus its commercialization activities on the North American
territory only and, as a result, will cease its
Trogarzo® commercialization operations in
Europe. The Company has sent a
notice of termination to TaiMed Biologics Inc. (TaiMed) as per our
contractual obligations and will return the European
commercialization rights to Trogarzo® for TaiMed
within the next 180 days. TaiMed is currently considering options
for the continued commercial availability of Trogarzo in
Europe.
"It is unfortunate that we had to come to this conclusion, but
the pricing and reimbursement conditions for Trogarzo®
in key European countries were not satisfactory to
Theratechnologies. While Trogarzo® is an important
and effective therapy for people living with HIV-1, the continued
commercial sale of Trogarzo® at the proposed pricing and
reimbursement conditions by various European governments would have
resulted in continuing losses for Theratechnologies. We intend to
honor our regulatory obligations vis-à-vis patients who are
currently receiving Trogarzo® over the required period
of time, and we will work with TaiMed to evaluate their options
regarding the continued commercial availability of
Trogarzo® in Europe",
said Paul Lévesque, President and Chief Executive Officer,
Theratechnologies. "The effect of such a decision means that we
will restructure our wholly-owned Dublin-based subsidiary and let go some of our
colleagues. However, not everyone will be impacted by this
decision as some roles which provide services to our global
operations will be retained. This decision will in no way impact
our commitment to providing our innovative medicines, Egrifta
SV® and Trogarzo®, to North American
patients, as we continue to focus on the execution of our
aggressive growth plans in the United
States", added Mr. Lévesque.
This decision is expected to result in approximately
US$1.5 to US$2.0 million in cash charges related to
severance and other expenses associated with the termination of the
agreement and approximately US$6.5
million in non-cash charges. We expect these charges to be
fully taken during 2022. European net sales in the past twelve
months represented less than 2% of our overall revenues and we
would like to reiterate that our revenue guidance remains unchanged
for the current fiscal year.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a
biopharmaceutical company focused on the development and
commercialization of innovative therapies addressing unmet medical
needs. Further information about Theratechnologies is available on
the Company's website at www.theratech.com, on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov.
Forward-Looking
Information
This press release contains forward-looking statements and
forward-looking information, or, collectively, forward-looking
statements, within the meaning of applicable securities laws, that
are based on our management's beliefs and assumptions and on
information currently available to our management. You can identify
forward-looking statements by terms such as "may", "will",
"should", "could", "promising", "would", "outlook", "believe",
"plan", "envisage", "anticipate", "expect" and "estimate", or the
negatives of these terms, or variations of them. The
forward-looking statements contained in this press release include,
but are not limited to, statements regarding our revenue guidance
for the 2022 full fiscal year, the costs associated to the
announced restructuring and sales of Egrifta SV® and
Trogarzo® in the United
States.
Although the forward-looking information contained in this press
release is based upon what the Company believes are reasonable
assumptions in light of the information currently available,
investors are cautioned against placing undue reliance on this
information since actual results may vary from the forward-looking
information. Certain assumptions made in preparing the
forward-looking statements include that: the current COVID-19
pandemic will have limited adverse effect on the Company's
operations; sales of EGRIFTA SV® and
Trogarzo® in the United
States will increase over time; the Company's commercial
practices in the United States
will not be found to be in violation of applicable laws; the
long-term use of EGRIFTA SV® and
Trogarzo® will not change their respective current
safety profile; no recall or market withdrawal of EGRIFTA
SV® and Trogarzo® will occur; no laws,
regulation, order, decree or judgment will be passed or issued by a
governmental body negatively affecting the marketing, promotion or
sale of EGRIFTA SV® and Trogarzo® in
countries where such products are commercialized; continuous supply
of EGRIFTA SV® and Trogarzo® will be
available; the Company's relations with third-party suppliers of
EGRIFTA SV® and Trogarzo® will be
conflict-free and such third-party suppliers will have the capacity
to manufacture and supply EGRIFTA SV® and
Trogarzo® to meet market demand on a timely basis; no
biosimilar version of EGRIFTA SV® will be
approved by the FDA; the Company's intellectual property will
prevent companies from commercializing biosimilar versions of
EGRIFTA SV® in the
United States; the assessment of the costs related to this
restructuring will be accurate and no material unexpected expenses
will be incurred as a result of such restructuring; and the
Company's long-term business plan will not be substantially
modified.
Forward-looking information assumptions are 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 risks and uncertainties
include, but are not limited to, those related to or arising from:
the adverse impact of the COVID-19 pandemic on (a) the Company's
sales efforts and sales initiatives, (b) the capacity of the
Company's suppliers to meet their obligations vis-à-vis the
Company, (c) the Company's research and development activities, as
well as (d) global trade; the Company's ability and capacity to
grow the sales of EGRIFTA SV® and
Trogarzo® successfully in the United States; the
Company's capacity to meet supply and demand for its products; the
market acceptance of EGRIFTA SV® and
Trogarzo® in the United States; the continuation of the
Company's collaborations and other significant agreements with its
existing commercial partners and third-party suppliers and its
ability to establish and maintain additional collaboration
agreements; the Company's success in continuing to seek and
maintain reimbursements for EGRIFTA SV® and
Trogarzo® by third-party payors in the United States;
the success and pricing of other competing drugs or therapies that
are or may become available in the marketplace; the Company's
ability to protect and maintain its intellectual property rights in
EGRIFTA SV® and tesamorelin; the Company's
expectations regarding its financial performance, including
revenues, expenses, gross margins, profitability, liquidity,
capital expenditures and income taxes; and the Company's estimates
regarding its capital requirements.
We refer current and potential investors to the "Risk Factors"
section of our Annual Information Form dated February 23, 2022 available on SEDAR at
www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our
report on Form 40-F dated February 24,
2022 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 statements reflect current expectations
regarding future events and speak only as of the date of this press
release and represent our expectations as of that date.
We undertake 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.
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SOURCE Theratechnologies Inc.