Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (Alexion or the Company)
today announced financial results for the three and six months ended
June 30, 2012. Alexion reported net product sales of Soliris®
(eculizumab) of $274.7 million in the second quarter of 2012, compared
to $185.7 million for the same period in 2011.
Revenue performance for the quarter reflected steady additions of new
patients with paroxysmal nocturnal hemoglobinuria (PNH) commencing
Soliris therapy in Alexion's core territories of the US, Western Europe
and Japan, as well as in new countries. Revenues were further augmented
by an increasing number of new patients with atypical hemolytic uremic
syndrome (aHUS) commencing Soliris treatment, as well as by $3.3 million
from shipments of Soliris that occurred in 2011.
Soliris is approved for patients with PNH in the US (2007), European
Union (2007), Japan (2010) and other territories as the first and only
treatment indicated for this ultra-rare, debilitating and
life-threatening blood disease. Soliris is also approved as the first
and only treatment for patients with aHUS, an ultra-rare,
life-threatening, genetic disease, in the US (September 2011) and in the
European Union (November 2011).
Alexion's non-GAAP operating results are equal to GAAP operating results
adjusted for the impact of share-based compensation, costs associated
with acquisitions, taxes that are not payable in cash (non-cash taxes)
attributable to the utilization of US net operating losses, and taxes
related to acquisition structuring. The following summary table is
provided for investors' convenience:
Second Quarter 2012 Non-GAAP Financial Results:
The Company reported non-GAAP net income of $94.1 million, or $0.47 per
share, in the second quarter of 2012, compared to non-GAAP net income of
$56.8 million, or $0.29 per share, in the second quarter of 2011.
Alexion's non-GAAP operating expenses for Q2 2012 were $142.2 million,
compared to $102.6 million for Q2 2011. Non-GAAP research and
development (R&D) expenses for Q2 2012 were $56.3 million, compared to
$33.4 million for Q2 2011. Non-GAAP selling, general and administrative
(SG&A) expenses for Q2 2012 were $85.9 million, compared to $69.2
million for Q2 2011.
Second Quarter 2012 GAAP Financial Results:
Alexion reported GAAP net income of $36.3 million, or $0.18 per share,
in the second quarter of 2012, compared to GAAP net income of $34.7
million, or $0.18 per share, in the second quarter of 2011. Q2 2012 GAAP
net income included $21.8 million of tax expense related to the
structuring of the Enobia acquisition.
On a GAAP basis, operating expenses for Q2 2012 were $159.4 million,
compared to $114.9 million for Q2 2011. GAAP R&D expenses for Q2 2012
were $59.6 million, compared to $35.6 million for Q2 2011. GAAP SG&A
expenses were $94.9 million for Q2 2012, compared to $78.2 million for
As of June 30, 2012, the Company had $806 million in cash and cash
equivalents, compared to $359 million at March 31, 2012. The Company
raised net proceeds of $462 million from the sale of 5,000,000 shares,
announced on May 23, 2012, in connection with its inclusion in the S&P
500 Index. The Company also reduced total debt from $355 million at
March 31, 2012 to $228 million at June 30, 2012.
"In the second quarter, we continued to provide Soliris to a substantial
number of new patients with PNH, both in our core territories and in new
countries, while also serving an increasing number of new patients with
aHUS," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "We
also advanced our eight lead development programs which include five
highly innovative biologics. In the second half of 2012, the global
Alexion team will drive forward to serve more patients with PNH and aHUS
around the world, and to bring life-transforming innovation to patients
with additional severe and life-threatening ultra-rare disorders."
Research and Development Programs:
Alexion currently has lead development programs underway with five
highly innovative therapeutics, including eculizumab (Soliris), which
are being investigated across eight severe and ultra-rare disorders
beyond PNH and aHUS.
Ultra-Rare Disease Programs With Eculizumab
Nephrology: STEC-HUS and Acute Humoral Kidney Rejection (AHR): The
European Commission has granted orphan designation for eculizumab as a
treatment for patients with STEC-HUS, a severe, ultra-rare, and
life-threatening inflammatory disorder. Separately, enrollment
continues in a Company-sponsored, multi-national, living-donor kidney
transplant trial in patients at elevated risk of acute humoral
rejection, also known as antibody mediated rejection, and the Company
has initiated a deceased-donor kidney transplant study with enrollment
expected to begin later this year.
Neurology: NMO and MG: Data from the investigator-initiated
Phase 2 clinical trial of eculizumab in severe and refractory
neuromyelitis optica (NMO) are expected to be presented at a
scientific meeting in the second half of 2012. Alexion is also
currently working with investigators to design the next clinical trial
to evaluate eculizumab as a treatment for patients with severe and
refractory myasthenia gravis (MG).
Ultra-Rare Disease Programs With Highly Innovative
Therapeutic Candidates Beyond Eculizumab
Asfotase Alfa: During Q2, Alexion initiated its planned natural
history study in infants with hypophosphatasia (HPP), an ultra-rare,
inherited, and life-threatening metabolic disease.
cPMP Replacement Therapy: The Company is conducting pre-IND
toxicology studies with its cPMP replacement therapy for the treatment
of patients with the severe, ultra-rare, and genetic, fatal metabolic
disorder Molybdenum Cofactor Deficiency Type A.
ALXN1102 (previously TT30): Enrollment continues in a Phase I
study to characterize the mechanism of action and develop initial
safety data for ALXN1102, a novel complement inhibitor.
ALXN1007: Enrollment continues in a Phase I study of ALXN1007,
a novel anti-inflammatory antibody, to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of this compound
in healthy volunteers.
2012 Financial Guidance:
Alexion today announced that it is raising its 2012 revenue guidance
from the previous range of $1.065 to $1.085 billion now to the higher
range of $1.110 to $1.125 billion. The upward revision reflects
continued global growth of Soliris in PNH and growth from the ongoing
launch of Soliris in aHUS. 2012 guidance for non-GAAP SG&A is being
increased from the previous range of $345 to $355 million, now to $360
to $370 million, reflecting continued investment in the growth of the
Company's global operations. Non-GAAP R&D guidance remains unchanged.
Guidance for 2012 non-GAAP earnings per share is being raised, from the
previous range of $1.65 to $1.75 per share, now to the higher range of
$1.78 to $1.88 per share for the year. Shares outstanding are expected
to be approximately 203 million in the third quarter and approximately
204 million in the fourth quarter. All other items of the 2012 financial
guidance provided in the Company's press release of April 24, 2012 are
being reiterated at this time.
Alexion Pharmaceuticals, Inc.