Alexion Revises Upward 2014 Financial Guidance for Revenues and non-GAAP EPS
CHESHIRE, Conn. -- March 10, 2014
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that it is
revising upward its previously provided 2014 financial guidance for net
product sales and non-GAAP earnings per share (EPS).
The Company will record increased revenue in 2014 related to an agreement that
brings to conclusion discussions with the French government and which
positively impacts prospective reimbursement of Soliris. The agreement also
provides reimbursement for shipments of Soliris made prior to January 1, 2014.
The agreement follows the 2012 French Transparency Commission designation,
with the ASMR 2 rating, of the important medical benefit of Soliris treatment
for patients with atypical hemolytic uremic syndrome (aHUS), and includes
reimbursement of Soliris for treatment of patients with both paroxysmal
nocturnal hemoglobinuria (PNH) and aHUS.
In the first quarter of 2014, the Company will record approximately $88
million of additional net product sales related to reimbursement for product
sales in prior years. As a result of this agreement, the Company has also
revised upward its 2014 revenue and non-GAAP EPS guidance to reflect its
current expectation for additional Soliris net product sales during the
remainder of 2014.
The Company is now providing the following upwardly revised 2014 guidance,
which includes net product sales related to years prior to 2014 to be recorded
in Q1 2014, as well as expectations for subsequent increased revenue during
the remainder of 2014:
*2014 net product revenue guidance is being increased from the prior range
of $2.000 to $2.020 billion to the higher range of $2.150 to $2.170
billion, which includes the $88 million in net product sales related to
years prior to 2014 to be recorded in Q1 2014.
*2014 non-GAAP EPS guidance is being increased from the prior range of
$3.70 to $3.80 to the higher range of $4.37 to $4.47, which includes 37
cents attributable to net product sales related to years prior to 2014 to
be recorded in Q1 2014.
Alexion is reiterating the other elements of its 2014 financial guidance
announced in its press release of January 30, 2014.
Soliris is a first-in-class terminal complement inhibitor developed from the
laboratory through regulatory approval and commercialization by Alexion.
Soliris is approved in the U.S. (2007), European Union (2007), Japan (2010)
and other countries as the first and only treatment for patients with
paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare and
life-threatening blood disorder, characterized by complement-mediated
hemolysis (destruction of red blood cells). Soliris is indicated to reduce
hemolysis. Soliris is also approved in the U.S. (2011), the European Union
(2011), Japan (2013) and other countries as the first and only treatment for
patients with atypical hemolytic uremic syndrome (aHUS), a debilitating,
ultra-rare and life-threatening genetic disorder characterized by
complement-mediated thrombotic microangiopathy, or TMA (blood clots in small
vessels). Soliris is indicated to inhibit complement-mediated TMA. The
effectiveness of Soliris in aHUS is based on its effects on TMA and renal
function. Prospective clinical trials in additional patients, the preliminary
results of which were reported at international nephrology and hematology
conferences in 2013, are ongoing to confirm the benefit of Soliris in patients
with aHUS. Soliris is not indicated for the treatment of patients with
Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). For the
breakthrough innovation in complement inhibition, Alexion and Soliris have
received the pharmaceutical industry's highest honors: the 2008 Prix Galien
USA Award for Best Biotechnology Product with broad implications for future
biomedical research and the 2009 Prix Galien France Award in the category of
Drugs for Rare Diseases.
More information including the full U.S. prescribing information on Soliris is
available at www.soliris.net.
Important Safety Information
The U.S. product label for Soliris includes a boxed warning: "Life-threatening
and fatal meningococcal infections have occurred in patients treated with
Soliris. Meningococcal infection may become rapidly life-threatening or fatal
if not recognized and treated early. Comply with the most current Advisory
Committee on Immunization Practices (ACIP) recommendations for meningococcal
vaccination in patients with complement deficiencies. Immunize patients with a
meningococcal vaccine at least two weeks prior to administering the first dose
of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of
developing a meningococcal infection. (See Serious Meningococcal Infections
(5.1) for additional guidance on the management of meningococcal infection.)
Monitor patients for early signs of meningococcal infections and evaluate
immediately if infection is suspected. Soliris is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
Under the Soliris REMS, prescribers must enroll in the program. Enrollment in
the Soliris REMS program and additional information are available by
telephone: 1-888-soliris (1-888-765-4747)."
In patients with PNH, the most frequently reported adverse events observed
with Soliris treatment in clinical studies were headache, nasopharyngitis
(runny nose), back pain and nausea. Soliris treatment of patients with PNH
should not alter anticoagulant management because the effect of withdrawal of
anticoagulant therapy during Soliris treatment has not been established. In
patients with aHUS, the most frequently reported adverse events observed with
Soliris treatment in clinical studies were hypertension, upper respiratory
tract infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract
infection, and leukopenia. Please see full prescribing information for
Soliris, including boxed WARNING regarding risk of serious meningococcal
Alexion is a biopharmaceutical company focused on serving patients with severe
and rare disorders through the innovation, development and commercialization
of life-transforming therapeutic products. Alexion is the global leader in
complement inhibition and has developed and markets Soliris® (eculizumab) as a
treatment for patients with PNH and aHUS, two debilitating, ultra-rare and
life-threatening disorders caused by chronic uncontrolled complement
activation. Soliris is currently approved in nearly 50 countries for the
treatment of PNH, and in the United States, European Union, Japan and other
countries for the treatment of aHUS. Alexion is evaluating other potential
indications for Soliris in additional severe and ultra-rare disorders beyond
PNH and aHUS, and is developing other highly innovative biotechnology product
candidates across multiple therapeutic areas. This press release and further
information about Alexion can be found at: www.alexionpharma.com.
This news release contains forward-looking statements, including statements
related to guidance regarding anticipated financial results for 2014 and
anticipated revenues resulting from ongoing commercial operations in France
and an agreement with the reimbursement authorities in that country.
Forward-looking statements are subject to factors that may cause Alexion's
results and plans to differ from those expected, including for example,
decisions of regulatory authorities regarding marketing approval or material
limitations on the marketing of Soliris for PNH and aHUS and other potential
indications, delays, interruptions or failures in the manufacture and supply
of Soliris and our product candidates, failure to address the issues raised by
the FDA in the Warning Letter received by Alexion in March 2013, the
possibility that current results of commercialization are not predictive of
future rates of adoption of Soliris in PNH, aHUS or other diseases, the risk
that estimates regarding the number of patients with PNH, aHUS or other
diseases are inaccurate, the risk that third party payors (including
governmental agencies) will not reimburse or continue to reimburse for the use
of Soliris at acceptable rates or at all, and a variety of other risks set
forth from time to time in Alexion's filings with the US Securities and
Exchange Commission, including but not limited to the risks discussed in
Alexion's Quarterly Report on Form 10-K for the period ended December 31, 2013
and in our other filings with the US Securities and Exchange Commission.
Alexion does not intend to update any of these forward-looking statements to
reflect events or circumstances after the date hereof, except when a duty
arises under law.
Irving Adler, 203-271-8210
Exec. Director, Corporate Communications
Kim Diamond, 203-439-9600
Senior Director, Corporate Communications
Rhonda Chiger, 917-322-2569
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