DUBLIN, Dec. 6, 2022 /PRNewswire/ -- Endo International
plc (OTC: ENDPQ) announced today that it will cease the
production and sale of Endo Aesthetics' Qwo®
(collagenase clostridium histolyticum-aaes) in light of market
concerns about the extent and variability of bruising following
initial treatment as well as the potential for prolonged skin
discoloration.
For more than a year, Endo worked to address those concerns,
including launching an open-label study in June 2022, APHRODITE, to test different
interventions and whether they might mitigate bruising. Although
certain APHRODITE study cohorts' results reflected a modest
reduction of bruising area and severity, none achieved a consistent
level of reduced bruising following initial treatment to adequately
alleviate the market's concerns.
"After careful consideration, we have determined that QWO does
not represent a viable commercial opportunity for Endo," said
Blaise Coleman, President and CEO of
Endo. "This difficult decision unfortunately results in a workforce
reduction. We are grateful for the dedication and hard work of all
team members who supported QWO and our Endo Aesthetics business,
and we are committed to providing support and assistance to our
impacted team members."
This decision is expected to result in annualized pre-tax cash
savings of approximately $50 million
to $60 million and a reduction to
Endo's global workforce of approximately 90 full-time positions. In
connection with ceasing QWO production and sales, the Company
expects to incur pre-tax cash restructuring charges of
approximately $15 million to
$20 million and record a total
pre-tax restructuring charge of approximately $235 million to $250
million in the fourth quarter 2022. The Company will seek
any necessary approvals from the United States Bankruptcy Court for
the Southern District of New York
in connection with this decision.
QWO remains an FDA-approved product with clinically proven
results and an established safety profile, so practices may
continue to use unexpired QWO that they have in stock, as well as
order additional supply. Alternatively, practitioners can return
unused QWO purchased prior to this announcement for a refund.
Practices will be notified about these options.
INDICATION
Qwo® is indicated for the
treatment of moderate to severe cellulite in the buttocks of adult
women.
IMPORTANT SAFETY INFORMATION FOR QWO
CONTRAINDICATIONS
QWO is contraindicated in patients
with a history of hypersensitivity to collagenase or to any of the
excipients or the presence of infection at the injection sites.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity
reactions including anaphylaxis have been reported with the use of
collagenase clostridium histolyticum. If such a reaction occurs,
further injection of QWO should be discontinued and appropriate
medical therapy immediately instituted. Advise patients to seek
immediate medical attention if they experience any symptoms of
serious hypersensitivity reactions.
Injection Site Bruising
In clinical trials, 84% of
subjects treated with QWO experienced injection site bruising.
Subjects with coagulation disorders or using anticoagulant or
antiplatelet medications (except those taking ≤150 mg aspirin
daily) were excluded from participating in Trials 1 and 2.
QWO should be used with caution in patients with bleeding
abnormalities or who are currently being treated with antiplatelet
(except those taking ≤150 mg aspirin daily) or anticoagulant
therapy.
Substitution of Collagenase Products
QWO must not be
substituted with other injectable collagenase products.
QWO is not intended for the treatment of Peyronie's Disease or
Dupuytren's Contracture.
ADVERSE REACTIONS
In clinical trials, the most
commonly reported adverse reactions in patients treated with QWO
with an incidence ≥ 10% were at the injection site: bruising, pain,
nodule and pruritus.
Click for Full Prescribing Information for
QWO.
About Endo
Endo (OTC: ENDPQ) is a specialty
pharmaceutical company committed to helping everyone we serve live
their best life through the delivery of quality, life-enhancing
therapies. Our decades of proven success come from passionate team
members around the globe collaborating to bring treatments forward.
Together, we boldly transform insights into treatments benefiting
those who need them, when they need them. Learn more
at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release may be
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation, including, but not limited to, the
statements by Mr. Coleman and any statements related to the
Company's efforts to expand and enhance its portfolio or the
decision to cease production and sale of QWO, including any
estimated expenses, charges, costs or savings, and any other
statements that refer to expected, estimated or anticipated future
results or that do not relate solely to historical facts.
Statements including words or phrases such as "believe," "expect,"
"anticipate," "intend," "estimate," "plan," "will," "may," "look
forward," "intend," "guidance," "future," "potential" or similar
expressions are forward-looking statements. All forward-looking
statements in this communication reflect the Company's current
views as of the date of this communication about its plans,
intentions, expectations, strategies and prospects, which are based
on the information currently available to it and on assumptions it
has made. Actual results may differ materially and adversely from
current expectations based on a number of factors, including, among
other things, the outcome of the Company's contingency planning and
restructuring activities; the timing, impact or results of any
pending or future litigation, investigations, proceedings or
claims, including opioid, tax and antitrust related matters; actual
or contingent liabilities; settlement discussions or negotiations;
the Company's liquidity, financial performance, cash position and
operations; the Company's strategy; risks and uncertainties
associated with chapter 11 proceedings; the negative impacts on the
Company's businesses as a result of filing for and operating under
chapter 11 protection; the time, terms and ability to confirm a
sale of the Company's businesses under Section 363 of the U.S.
Bankruptcy Code; the adequacy of the capital resources of the
Company's businesses and the difficulty in forecasting the
liquidity requirements of the operations of the Company's
businesses; the unpredictability of the Company's financial results
while in chapter 11 proceedings; the Company's ability to discharge
claims in chapter 11 proceedings; negotiations with the holders of
the Company's indebtedness and its trade creditors and other
significant creditors; and risks and uncertainties with performing
under the terms of the restructuring support agreement and any
other arrangement with lenders or creditors while in chapter 11
proceedings. The Company expressly disclaims any intent or
obligation to update these forward-looking statements, except as
required to do so by law.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by the
Company, as well as the Company's public periodic filings with the
U.S. Securities and Exchange Commission and with securities
regulators in Canada, including
the discussion under the heading "Risk Factors" in the Company's
most recent Annual Report on Form 10-K and any subsequent Quarterly
Reports on Form 10-Q or other filings with the U.S. Securities and
Exchange Commission. Copies of the Company's press releases and
additional information about the Company are available at
www.endo.com or you can contact the Company's Investor Relations
Department at relations.investor@endo.com.
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