– Soliris® (eculizumab) Net Product Sales of
$636 Million; Increased 24% Year-on-Year Despite Currency
Headwinds; 31% Volume Increase Year-on-Year –
– 2015 Revenue Guidance Increased Reflecting
Strong Growth of Soliris in PNH and aHUS –
– Positive CHMP Opinions Received for Strensiq™
(asfotase alfa) for Hypophosphatasia (HPP) and Kanuma™ (sebelipase
alfa) for Lysosomal Acid Lipase Deficiency (LAL-D) in the European
Union –
– Strensiq Approved in Japan; Kanuma NDA Filed
in Japan –
– Exceeded Target Enrollment in Eculizumab
Refractory Myasthenia Gravis Registration Trial –
– Completed Synageva Acquisition –
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced
financial results for the second quarter of 2015. Net product sales
of Soliris® (eculizumab) grew to $636 million, a 24% increase,
compared to $512.5 million for the same period in 2014, despite
currency headwinds. Non-GAAP diluted earnings per share (EPS) for
the second quarter of 2015 were $1.44, compared to $1.12 in the
second quarter of 2014. On a GAAP basis, diluted EPS for the second
quarter of 2015 was $0.83 per share, impacted by $40.1 million, or
$0.20 per share, related to acquisition and restructuring costs
resulting from the Synageva acquisition, compared to $0.83 in the
second quarter of 2014.
“In the second quarter of 2015, we achieved many significant
commercial, development and financial milestones while also closing
the Synageva acquisition to strengthen our position as the global
leader in serving patients with devastating and rare diseases,”
said David Hallal, Chief Executive Officer of Alexion. “In the
second half of 2015, we will continue to serve more patients with
PNH and aHUS, while simultaneously launching Strensiq and Kanuma
globally, and advancing our broad pipeline of innovative therapies
to support our future growth.”
Second Quarter 2015 Financial
Highlights
- Net product sales of Soliris® were $636
million compared to $512.5 million in the same quarter last
year.
- Non-GAAP R&D expense was $116.6
million compared to $85.1 million in the same quarter last year.
GAAP R&D expense was $131.7 million compared to $92.6 million
in the same quarter last year.
- Non-GAAP SG&A expense was $169.1
million compared to $139.5 million in the same quarter last year.
GAAP SG&A expense was $221.4 million compared to $159.5 million
in the same quarter last year.
- Non-GAAP effective tax rate was a
benefit of 0.6% compared to tax expense of 8.0% in the same quarter
last year. In Q2 2015, the Company benefitted from the utilization
of operating losses from Synageva in 2015.
- Non-GAAP diluted EPS was $1.44,
compared to $1.12 in the same quarter last year. On a GAAP basis,
diluted EPS was $0.83 compared to $0.83 in the same quarter last
year. Q2 2015 GAAP EPS was impacted by $40.1 million, or $0.20 per
share, related to acquisition and restructuring costs resulting
from the Synageva acquisition.
- As of June 30, 2015, Alexion had cash,
cash equivalents and marketable securities of $1.5 billion.
Product and Pipeline
Updates
Complement Portfolio
- Neurology- Myasthenia Gravis
(MG): Alexion exceeded the target enrollment in the REGAIN
study, a single, multinational, placebo-controlled, registration
trial of eculizumab in refractory MG.
- Neurology- Neuromyelitis Optica
(NMO): Alexion expects to complete enrollment in the PREVENT
study, a single, multinational, placebo-controlled, registration
trial of eculizumab in relapsing NMO, in 2016.
- Kidney Transplant- Delayed Graft
Function (DGF): Alexion expects to complete enrollment in the
PROTECT study, a single, multinational DGF prevention registration
trial with eculizumab, in 2015.
- Kidney Transplant- Antibody-Mediated
Rejection (AMR): Alexion reported preliminary 1-year data from
a single-arm Phase 2 study of eculizumab in the prevention of acute
AMR in sensitized deceased-donor kidney transplant recipients at
the American Transplant Congress.
- ALXN 1210 and ALXN 5500: The
Company advanced Phase 1 studies with its first two next-generation
Soliris molecules, and expects to initiate a Phase 2 trial with
ALXN 1210 in patients with paroxysmal nocturnal hemoglobinuria
(PNH) in 2015.
- ALXN 1007: Enrollment and dosing
are ongoing in two Phase 2 proof-of-concept studies in patients
with graft versus host disease involving the lower gastrointestinal
tract (GI-GVHD) and antiphospholipid syndrome (APS), two severe,
autoimmune diseases with potentially life-threatening
complications. Alexion expects to have interim data from the
GI-GVHD study later this year.
Metabolic Portfolio
- Strensiq™ (asfotase
alfa): Strensiq received a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) recommending marketing authorization for
long-term enzyme replacement therapy in patients with
pediatric-onset HPP. Strensiq was also approved by Japan’s Ministry
of Health, Labour and Welfare (MHLW) for the treatment of patients
with HPP. The regulatory process for Strensiq in the U.S. is
ongoing. The Food and Drug Administration (FDA) previously granted
Breakthrough Therapy designation for Strensiq and accepted
Alexion’s Biologics License Application (BLA) for Priority
Review.
- Kanuma™ (sebelipase alfa):
Kanuma received a positive CHMP opinion from the EMA recommending
marketing authorization for long-term enzyme replacement therapy in
patients of all ages with lysosomal acid lipase deficiency (LAL-D).
In Q2, a New Drug Application for Kanuma was also submitted to
Japan’s MHLW as a treatment for patients with LAL-D. The regulatory
process for Kanuma in the U.S. is ongoing. The FDA granted
Breakthrough Therapy designation for Kanuma for LAL-D presenting in
infants and accepted the BLA for Priority Review.
- SBC-103: Enrollment was
completed in a Phase 1/2 trial of SBC-103, an enzyme replacement
therapy being investigated for patients with mucopolysaccharidosis
IIIB, or MPS IIIB. Preliminary data are expected in the second half
of 2015.
- cPMP Replacement Therapy (ALXN
1101): Alexion completed enrollment in the synthetic cPMP
bridging study in patients with molybdenum cofactor deficiency
(MoCD) Type A and enrollment in a natural history study is ongoing.
The Company plans to initiate a pivotal study with ALXN 1101 by the
end of 2015. Alexion received Breakthrough Therapy designation for
its cPMP replacement therapy in 2013.
Preclinical Portfolio
- Alexion has more than 30 diverse
pre-clinical programs across a range of therapeutic modalities,
with four of these programs expected to enter the clinic in
2016.
2015 Financial Guidance
Alexion today announced that the Company is revising upward its
revenue guidance for 2015 from the previous range of $2.55 to $2.6
billion, now to the higher and narrower range of $2.6 to $2.62
billion, which includes an approximately negative 6 percent, or
$160 million, foreign exchange impact compared to 2014 exchange
rates.
Alexion is reducing its 2015 non-GAAP tax rate guidance to
the lower range of 3 percent to 4 percent, from the previous range
of 7 percent to 9 percent. Alexion is also reducing its longer-term
non-GAAP tax rate guidance to the lower range of 12 percent to
14 percent in 2019 and beyond, from the previous range of 14
percent to 16 percent, a reduction of 2 percent.
Alexion is also revising 2015 non-GAAP financial guidance as
follows, which reflects the inclusion of Synageva financial results
into Alexion’s consolidated results beginning June 22, 2015, the
acquisition closing date:
Cost of sales 8% to 9% of net product
sales Research and development expense $520 to $540 million
Selling, general and administrative expense $690 to $710 million
Interest expense
$55 million
Effective tax rate 3% to 4 % Diluted shares outstanding 219 million
As a result of these changes, Alexion is revising 2015 non-GAAP
EPS guidance to the range of $4.70 to $4.80 per share, from the
previous range of $5.60 to $5.80 per share.
Conference Call/Webcast Information
Alexion will host a conference call/audio webcast to discuss
matters mentioned in this release. The call is scheduled for today,
July 30, at 10:00 a.m., Eastern Time. To participate in this call,
dial 1-888-500-6973 (USA) or + 719-457-2643 (International),
passcode 3227303 shortly before 10:00 a.m., Eastern Time. A replay
of the call will be available for a limited period following the
call, beginning at 1:00 p.m., Eastern Time. The replay number is
1-888-203-1112 (USA) or +1-719-457-0820 (International), passcode
3227303. The audio webcast and slide presentation can be accessed
on the Investor page of Alexion’s website at:
http://ir.alexionpharm.com.
About Soliris® (eculizumab)
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) to reduce hemolysis. PNH is a debilitating,
ultra-rare and life-threatening blood disorder, characterized by
complement-mediated hemolysis (destruction of red blood cells).
Soliris is also approved in the U.S. (2011), European Union (2011),
Japan (2013) and other countries as the first and only treatment
for patients with atypical hemolytic uremic syndrome (aHUS) to
inhibit complement-mediated thrombotic microangiopathy, or TMA
(blood clots in small vessels). aHUS is a debilitating, ultra-rare
and life-threatening genetic disorder characterized by
complement-mediated TMA. Soliris is not indicated for the treatment
of patients with Shiga-toxin E. coli-related hemolytic uremic
syndrome (STEC-HUS). For the breakthrough medical innovation in
complement inhibition, Alexion and Soliris have received some of
the pharmaceutical industry's highest honors: the Prix Galien USA
(2008, Best Biotechnology Product) and France (2009, Rare Disease
Treatment).
More information including the full U.S. prescribing information
on Soliris is available at www.soliris.net.
About Strensiq™ (asfotase alfa)
Strensiq™ (asfotase alfa) is an investigational first-in-class
bone-targeted enzyme replacement therapy designed to address the
underlying cause of hypophosphatasia (HPP)—deficient alkaline
phosphatase (ALP). By replacing deficient ALP, treatment with
Strensiq aims to improve the elevated enzyme substrate levels and
improve the body's ability to mineralize bone, thereby preventing
serious skeletal and systemic patient morbidity and premature
death.
The FDA granted Breakthrough Therapy designation for Strensiq
and accepted Alexion’s Biologics License Application (BLA) for
Priority Review. Alexion has also submitted a Marketing
Authorization Application (MAA) for Strensiq to the EMA. Strensiq
is approved by Japan’s Ministry of Health, Labour and Welfare
(MHLW) for the treatment of patients with HPP.
About Kanuma™ (sebelipase alfa)
Kanuma™ (sebelipase alfa) is an investigational first-in-class
enzyme replacement therapy designed to address the underlying cause
of lysosomal acid lipase deficiency (LAL-D). By replacing deficient
LAL, treatment with Kanuma aims to reduce substrate accumulation
and improve lipid metabolism to prevent chronic lipid accumulation,
vital organ damage and premature death.
The FDA granted Breakthrough Therapy designation for Kanuma for
LAL Deficiency presenting in infants. The FDA accepted the Kanuma
BLA for Priority Review, and the EMA validated the MAA for Kanuma
and is reviewing it under accelerated assessment. In addition, a
New Drug Application for Kanuma has been submitted to Japan’s
MHLW.
About Alexion
Alexion is a global biopharmaceutical company focused on
developing and delivering life-transforming therapies for patients
with devastating and rare disorders. Alexion developed and
commercializes Soliris® (eculizumab), the first and only approved
complement inhibitor to treat patients with paroxysmal nocturnal
hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS),
two life-threatening ultra-rare disorders. Alexion is also
establishing a premier global metabolic rare disease franchise with
the development of two late-stage therapies, Strensiq™ (asfotase
alfa) for hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) for
Lysosomal Acid Lipase Deficiency (LAL-D). In addition, Alexion is
advancing the most robust rare disease pipeline in the biotech
industry, with highly innovative product candidates in multiple
therapeutic areas. As the global leader in complement inhibition,
Alexion is strengthening and broadening its portfolio of complement
inhibitors across diverse platforms, including evaluating potential
indications for Soliris in additional severe and ultra-rare
disorders. This press release and further information about Alexion
can be found at: www.alexion.com.
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial
results for 2015, assessment of the Company's financial position
and commercialization efforts, medical benefits and commercial
potential for Soliris, Strensiq and Kanuma, medical and commercial
potential of Alexion's complement-inhibition technology and other
technologies, commercial potential associated with the expected
launches of Strensiq and Kanuma in 2015, and plans for clinical
programs for each of our product candidates. 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 our products, delays,
interruptions or failures in the manufacture and supply of our
products and our product candidates, progress in establishing and
developing commercial infrastructure, failure to satisfactorily
address the issues raised by the FDA in regulatory correspondence,
the possibility that results of clinical trials are not predictive
of safety and efficacy results of our products in broader patient
populations in the disease studied or other diseases, the risk that
strategic transactions will not result in short-term or long-term
benefits, the possibility that current results of commercialization
are not predictive of future rates of adoption of Soliris in PNH,
aHUS or other diseases, the possibility that clinical trials of our
product candidates could be delayed or that additional research and
testing is required by regulatory agencies, the adequacy of our
pharmacovigilance and drug safety reporting processes, the risk
that third party payors (including governmental agencies) will not
reimburse or continue to reimburse for the use of our products at
acceptable rates or at all, risks regarding government
investigations, the risk that estimates regarding the number of
patients with PNH, aHUS or other diseases are inaccurate, and a
variety of other risks set forth from time to time in Alexion's
filings with the U.S. Securities and Exchange Commission, including
but not limited to the risks discussed in Alexion's Quarterly
Report on Form 10-Q for the period ended March 31, 2015 and in our
other filings with the U.S. Securities and Exchange Commission,
including the Registration Statement on Form S-4 filed on May 22,
2015. 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.
In addition to financial information prepared in accordance with
GAAP, this news release also contains non-GAAP financial measures
that Alexion believes, when considered together with the GAAP
information, provide investors and management with supplemental
information relating to performance, trends and prospects that
promote a more complete understanding of our operating results and
financial position during different periods. The non-GAAP results
exclude the impact of the following GAAP items: share-based
compensation expense, acquisition-related costs, upfront and
milestone payments related to license and collaboration agreements,
intangible asset impairments, restructuring expenses, and non-cash
taxes. These non-GAAP financial measures are not intended to be
considered in isolation or as a substitute for, or superior to, the
financial measures prepared and presented in accordance with GAAP
and should be reviewed in conjunction with the relevant GAAP
financial measures. Please refer to the attached Reconciliation of
GAAP to Non-GAAP Financial Results for explanations of the amounts
adjusted to arrive at non-GAAP net income and non-GAAP earnings per
share amounts for the three and six month periods ended June 30,
2015 and 2014.
(Tables Follow)
ALEXION PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except
per share amounts) (unaudited)
Three months ended Six months ended
June 30 June 30 2015 2014 2015
2014 Net product sales $ 635,983 $ 512,495 $
1,236,316 $ 1,079,111 Other revenue 227 -
227 - Total revenues 636,210 512,495
1,236,543 1,079,111 Cost of sales 52,007 39,626 121,406
72,565 Operating expenses: Research and development 131,693
92,554 352,773 284,011 Selling, general and administrative 221,383
159,477 408,499 288,768 Impairment of intangible asset - - - 3,464
Acquisition-related costs 33,821 1,989 45,800 1,951 Restructuring
expenses 16,224 - 23,276 - Total
operating expenses 403,121 254,020
830,348 578,194 Operating income
181,082 218,849 284,789 428,352 Other income (expense)
(3,790 ) (203 ) (552 ) 2,205
Income before income taxes 177,292 218,646 284,237 430,557
Income tax provision 7,077 52,151 22,699 104,708
Net income $ 170,215 $ 166,495 $
261,538 $ 325,849 Earnings per common share Basic $
0.84 $ 0.84 $ 1.30 $ 1.65 Diluted $ 0.83
$ 0.83 $ 1.29 $ 1.62 Shares used in
computing earnings per common share Basic 202,234
197,880 200,806 197,838 Diluted
204,546 201,524 203,302
201,715
ALEXION PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (in
thousands, except per share amounts) (unaudited)
Three months ended Six months
ended June 30 June 30 2015
2014 2015 2014 Net income
reconciliation: GAAP net income $ 170,215 $ 166,495 $ 261,538 $
325,849 Share-based compensation expense 67,000 28,414
109,797 52,254 Acquisition-related costs (1) 33,821 1,989 48,778
1,951 Upfront and milestone payments related to license and
collaboration agreements 1,750 - 114,250 101,925 Impairment of
intangible assets - - - 3,464
Restructuring expenses (2)
16,224 - 23,276 -
Non-cash taxes (3)
8,722 32,174 5,050 56,228 Non-GAAP net
income $ 297,732 $ 229,072 $ 562,689 $ 541,671
GAAP earnings per share - diluted $ 0.83 $
0.83 $ 1.29 $ 1.62 Non-GAAP earnings per share
- diluted $ 1.44 $ 1.12 $ 2.72 $ 2.65
Shares used in computing diluted earnings per share (GAAP)
204,546 201,524 203,302
201,715 Shares used in computing diluted earnings per
share (non-GAAP) 206,934 204,435
205,488 204,631
Cost of sales
reconciliation: GAAP cost of sales $ 52,007 $ 39,626 $ 121,406
$ 72,565 Share-based compensation expense (1,344 )
(964 ) (2,753 ) (1,847 ) Non-GAAP cost of sales $
50,663 $ 38,662 $ 118,653 $ 70,718
Research and development expense reconciliation: GAAP
research and development expense $ 131,693 $ 92,554 $ 352,773 $
284,011 Share-based compensation expense (13,329 ) (7,453 ) (24,413
) (15,437 ) Upfront and milestone payments related to license and
collaboration agreements (1,750 ) -
(114,250 ) (101,925 ) Non-GAAP research and development
expense $ 116,614 $ 85,101 $ 214,110 $ 166,649
Selling, general and administrative expense
reconciliation: GAAP selling, general and administrative
expense $ 221,383 $ 159,477 $ 408,499 $ 288,768 Share-based
compensation expense (52,327 ) (19,997 )
(82,631 ) (34,970 ) Non-GAAP selling, general and
administrative expense $ 169,056 $ 139,480 $ 325,868
$ 253,798
Income tax provision
reconciliation: GAAP income tax provision $ 7,077 $ 52,151 $
22,699 $ 104,708
Non-cash taxes (3)
(8,722 ) (32,174 ) (5,050 ) (56,228 )
Non-GAAP income tax provision (benefit) $ (1,645 ) $ 19,977
$ 17,649 $ 48,480
(1) The following table summarizes acquisition-related
costs:
Three months ended Six months
ended June 30 June 30 2015
2014 2015 2014 Acquisition-related
costs: Transaction costs $ 26,799 $ - $ 29,777 $ - Integration
costs 2,978 - 2,978 - Changes in fair value of contingent
consideration 4,044 1,989 16,023 1,951
$ 33,821 $ 1,989 $ 48,778 $ 1,951 (2)
Restructuring expenses of $16.2 million
were related to $10.3 million resulting from the Synageva
acquisition and an additional $5.9 million related to the European
headquarters relocation.
(3)
Non-cash taxes represents the adjustment
from GAAP tax expense to the amount of taxes that are payable
(receivable) in cash in the current period. In the second quarter
2015, the Company completed the acquisition of Synageva which
resulted in a benefit to both GAAP and non-GAAP taxes from the
utilization of Synageva's operating losses in 2015. The tax benefit
recorded in the second quarter is resulting from the application of
the lower full year tax rate to the first half of the year.
ALEXION PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)
(unaudited) June 30, December
31, 2015 2014 Cash and cash equivalents $
1,322,123 $ 943,999 Marketable securities 172,229 1,017,567 Trade
accounts receivable, net 535,824 432,888 Inventories 234,347
176,441 Prepaid expenses and other current assets 268,715 225,134
Property, plant and equipment, net 555,388 392,248 Intangible
assets, net 4,824,520 587,046 Goodwill 5,007,142 254,073 Other
assets 247,431 172,566 Total assets $ 13,167,719 $
4,201,962 Accounts payable and accrued expenses $ 454,384 $
439,248 Deferred revenue 88,366 58,837 Current portion of long-term
debt 131,250 48,000
Deferred tax liabilities, current
42,018 12,476 Other current liabilities 53,151 48,179 Long-term
debt, less current portion 3,368,750 9,500 Facility lease
obligation 129,560 107,099 Contingent consideration 129,546 116,425
Other liabilities 217,823 60,180 Total liabilities
4,614,848 899,944 Total stockholders' equity
8,552,871 3,302,018 Total liabilities and
stockholders' equity $ 13,167,719 $ 4,201,962
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150730005382/en/
Alexion:MediaStephanie Fagan,
203-271-8223Senior Vice President, Corporate CommunicationsorKim
Diamond, 203-439-9600Executive Director, Corporate
CommunicationsorInvestorsElena Ridloff, CFA,
203-699-7722Executive Director, Investor Relations
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From Apr 2023 to Apr 2024