[February 03, 2016] |
|
Alexion Reports Fourth Quarter and Full Year 2015 Results and Provides Financial Guidance for 2016
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial
results for the fourth quarter and full year of 2015. Total revenues for
the full year of 2015 were $2.604 billion compared to $2.146 billion for
the full year 2014, representing 21 percent revenue growth, excluding
the impact of $88 million in 2014 for reimbursement of shipments in
prior years. In 2015, the negative impact of currency on total revenue
was 8 percent, or $165 million, net of hedging activities, compared to
the prior year. Non-GAAP diluted earnings per share (EPS) for the full
year of 2015 was $4.99 per share, compared to $5.21 per share in 2014.
Full year 2014 non-GAAP EPS included $0.37 per share related to
reimbursement of shipments in prior years. On a GAAP basis, Alexion
reported diluted EPS of $0.67 per share for the full year 2015, compared
to $3.26 per share in 2014. Full year 2014 GAAP EPS included $0.31 per
share related to reimbursement of prior year shipments.
Total revenues in the fourth quarter were $701 million, a 17 percent
increase, compared to $600 million from the same period in 2014. In the
fourth quarter, the negative impact of currency on total revenue was 8
percent or $45 million, net of hedging activities, compared to the same
quarter last year. Non-GAAP diluted EPS for the fourth quarter of 2015
was $1.13, compared to $1.30 in the fourth quarter of 2014. On a GAAP
basis, diluted EPS for the fourth quarter of 2015 was $0.29 per share,
compared to $0.76 in the fourth quarter of 2014.
"2015 was a transformative year for Alexion as we grew our complement
franchise, commenced building a premier metabolic franchise with the
global approvals of two new therapies, and simultaneously advanced the
most robust rare disease pipeline in biotech," said David Hallal, Chief
Executive Officer of Alexion. "In 2016 we will continue to focus on
serving an increasing number of patients with PNH and aHUS globally,
executing on the global launches of Strensiq and Kanuma, and advancing
our complement and metabolic pipeline programs to drive our future
growth. We look forward to reporting on multiple milestones in our
expanding development pipeline in 2016, including results from two
registration trials, and our broad and innovative mid-stage development
programs."
Full Year 2015 Financial Results
-
Soliris® (eculizumab) net product sales were $2.590 billion
compared to $2.146 billion in 2014, excluding the impact of $88
million in 2014 for reimbursement of shipments in prior years.
-
Strensiq® (asfotase alfa) net product sales were $12
million.
-
Non-GAAP R&D expense was $516 million compared to $368 million for
2014. GAAP R&D expense was $709 million compared to $514 million for
2014.
-
Non-GAAP SG&A expense was $706 million compared to $556 million in
2014. GAAP SG&A expense was $863 million compared to $630 million in
2014.
-
Non-GAAP diluted EPS was $4.99, compared to $5.21 in 2014. Full year
2014 non-GAAP EPS included $0.37 per share related to reimbursement of
prior year shipments. On a GAAP basis, diluted EPS was $0.67 per share
compared to $3.26 in 2014. Full year 2014 GAAP EPS included $0.31 per
share related to reimbursement of prior year shipments.
-
As of December 31, 2015, Alexion held cash, cash equivalents and
marketable securities of $1.385 billion.
Fourth Quarter 2015 Financial Results
-
Soliris net product sales were $689 million compared to $600 million
in the same quarter last year, despite continued currency headwinds as
well as macroeconomic factors in Latin American countries.
-
Strensiq net product sales were $11.6 million.
-
Non-GAAP R&D expense was $155 million compared to $108 million in the
same quarter last year. GAAP R&D expense was $191 million compared to
$129 million in the same quarter last year.
-
Non-GAAP SG&A expense was $198 million compared to $164 million in the
same quarter last year. GAAP SG&A expense was $242 million compared to
$184 million in the same quarter last year.
-
Non-GAAP diluted EPS was $1.13, compared to $1.30 in the same quarter
last year. On a GAAP basis, diluted EPS was $0.29 per share compared
to $0.76 in the same quarter last year.
Product and Pipeline Updates
Complement Portfolio
-
Eculizumab- Myasthenia Gravis (MG): Enrollment is complete in
the REGAIN study, a single, multinational, placebo-controlled,
registration trial of eculizumab in refractory MG, and preliminary
data are expected in mid-2016.
-
Eculizumab- Neuromyelitis Optica Spectrum Disorder (NMOSD): Alexion
expects to complete enrollment in the PREVENT study, a single,
multinational, placebo-controlled, registration trial of eculizumab in
relapsing NMOSD, in 2016.
-
Eculizumab- Delayed Graft Function (DGF): Enrollment is
complete in the PROTECT study, a single, multinational DGF prevention
registration trial with eculizumab, and preliminary data are expected
in the second half of 2016.
-
ALXN1210: Alexion has completed enrollment in a Phase 1/2
clinical study of ALXN1210, its highly innovative longer-acting C5
antibody, in patients with paroxysmal nocturnal hemoglobinuria (PNH)
and is enrolling patients in a Phase 2 PNH study. In the fourth
quarter, Alexion reported data showing a rapid reduction of LDH in
initial patients with PNH receiving ALXN1210. Alexion expects to
initiate a clinical program in patients with atypical hemolytic uremic
syndrome (aHUS) in 2016.
-
ALXN1007: Enrollment is ongoing in a Phase 2 proof-of-concept
study of ALXN1007, a complement inhibitor that targets C5a, in
patients with graft-versus-host disease involving the lower
gastrointestinal tract (GI-GVHD). In the fourth quarter, Alexion
reported interim Phase 2 data, showing an overall response rate at 28
days in patients with acute GI-GVHD.
Metabolic Portfolio
-
Strensiq: Strensiq was approved by the U.S. Food and Drug
Administration (FDA) under Breakthrough Therapy Designation and
Priority Review for the treatment of patients with perinatal-,
infantile- and juvenile-onset hypophosphatasia (HPP) in the fourth
quarter of 2015. Alexion received a Rare Pediatric Disease Priority
Review Voucher with the FDA approval. Strensiq was also approved in
the European Union and Japan in the third quarter of 2015.
-
Kanuma™ (sebelipase alfa): Kanuma was approved by the FDA under
Breakthrough Therapy Designation and Priority Review for the treatment
of patients of all ages with a diagnosis of lysosomal acid lipase
deficiency (LAL-D) in the fourth quarter of 2015, and launched in the
first quarter of 2016. Alexion received a Rare Pediatric Disease
Priority Review Voucher with the FDA approval. Kanuma was also
approved in the European Union in the third quarter of 2015.
-
SBC-103: Alexion is enrolling patients in a Phase 1/2 trial of
SBC-103, a recombinant form of the NAGLU enzyme, in patients with
mucopolysaccharidosis IIIB, or MPS IIIB or Sanfilippo B. In the fourth
quarter, Alexion reported interim data showing a dose-dependent
reduction in heparan sulfate levels in cerebral spinal fluid at 12
weeks in patients with MPS-IIIB. Six-month data will be presented as a
late-breaker abstract at the WORLDSymposium meeting in March.
Alexion has also completed enrollment in a natural history study of
patients with MPS IIIB.
-
cPMP Replacement Therapy (ALXN 1101): Alexion has initiated a
pivotal study to evaluate ALXN1101 in neonates with Molybdenum
Cofactor Deficiency (MoCD) Type A. Alexion received Breakthrough
Therapy designation for its cPMP replacement therapy.
Preclinical Portfolio
-
Alexion has more than 30 diverse preclinical programs across a range
of therapeutic modalities, with four of these programs expected to
enter the clinic in 2016.
2016 Financial Guidance
On a non-GAAP basis, 2016 financial guidance is as follows:
|
|
|
Constant Currency Guidance (1)
|
|
|
Foreign Exchange
|
|
|
Financial Guidance (2)
|
Total product revenues
|
|
|
$3,170 to $3,220 million
|
|
|
($120 million)
|
|
|
$3,050 to $3,100 million
|
Soliris revenues
|
|
|
|
|
|
|
|
|
$2,900 to $2,925 million
|
Metabolic franchise revenues
|
|
|
|
|
|
|
|
|
$150 to $175 million
|
Cost of sales
|
|
|
|
|
|
|
|
|
8% to 9%
|
Research and development expense
|
|
|
|
|
|
|
|
|
$650 to $680 million
|
Selling, general and administrative expense
|
|
|
|
|
|
|
|
|
$760 to $790 million
|
Interest expense
|
|
|
|
|
|
|
|
|
$100 million
|
Effective tax rate
|
|
|
|
|
|
|
|
|
7% to 8%
|
Earnings per share
|
|
|
$5.31 to $5.51
|
|
|
($0.31)
|
|
|
$5.00 to $5.20
|
Diluted shares outstanding
|
|
|
|
|
|
|
|
|
230 million
|
(1)
|
|
Constant currency revenues are based on actual foreign exchange
rates realized in 2015.
|
(2)
|
|
Financial guidance is based on forecasted results at current spot
rate net of hedging activities.
|
|
|
|
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, February 3,
at 10:00 a.m., Eastern Time. To participate in this conference call,
dial 877-856-1968 (USA) or 719-325-4815 (International), passcode
1542166 shortly before 10:00 a.m. ET. A replay of the call will be
available from 1:00 p.m. ET for a limited time by dialing 888-203-1112
(USA) or 719-457-0820 (International), passcode 1542166. The audio
webcast can be accessed on the Investor page of http://ir.alexionpharm.com.
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. As the global leader in complement inhibition, Alexion is
strengthening and broadening its portfolio of complement inhibitors,
including evaluating potential indications for eculizumab in additional
severe and ultra-rare disorders. Alexion's metabolic franchise includes
two highly innovative enzyme replacement therapies for patients with
life-threatening and ultra-rare disorders, Strensiq®
(asfotase alfa) to treat patients with hypophosphatasia (HPP) and
Kanuma™ (sebelipase alfa) to treat patients with 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. 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 2016, 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 each
of Alexion's product candidates, launch expectations for Strensiq and
Kanuma, and plans for clinical programs for 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
matters raised by the FDA and other regulatory agencies, 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, including the SEC and DOJ investigations, the
risk that estimates regarding the number of patients with PNH, aHUS, HPP
and LAL-D are inaccurate, the risks of shifting foreign exchange rates,
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 September 30, 2015 and in our other filings
with the U.S. 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.
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, fair value
adjustment of inventory acquired, amortization of purchased intangible
assets, changes in fair value of contingent consideration,
acquisition-related costs, restructuring expenses, intangible asset
impairments, upfront and milestone payments related to license and
collaboration agreements, 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 twelve month periods ended
December 31, 2015 and 2014.
(Tables Follow)
|
ALEXION PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Twelve months ended
|
|
|
|
December 31
|
|
|
December 31
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
$
|
700,425
|
|
|
$
|
599,476
|
|
|
|
$
|
2,602,532
|
|
|
$
|
2,233,733
|
|
Other revenue
|
|
|
|
442
|
|
|
|
-
|
|
|
|
|
1,515
|
|
|
|
-
|
|
Total revenues
|
|
|
|
700,867
|
|
|
|
599,476
|
|
|
|
|
2,604,047
|
|
|
|
2,233,733
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
57,626
|
|
|
|
49,439
|
|
|
|
|
233,089
|
|
|
|
173,862
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
191,035
|
|
|
|
129,110
|
|
|
|
|
709,472
|
|
|
|
513,782
|
|
Selling, general and administrative
|
|
|
|
241,576
|
|
|
|
183,776
|
|
|
|
|
862,595
|
|
|
|
630,209
|
|
Amortization of purchased intangible assets
|
|
|
|
79,976
|
|
|
|
-
|
|
|
|
|
116,584
|
|
|
|
-
|
|
Change in fair value of contingent consideration
|
|
|
|
18,550
|
|
|
|
10,041
|
|
|
|
|
64,257
|
|
|
|
20,295
|
|
Acquisition-related costs
|
|
|
|
3,358
|
|
|
|
-
|
|
|
|
|
39,210
|
|
|
|
-
|
|
Restructuring expenses
|
|
|
|
11,432
|
|
|
|
15,365
|
|
|
|
|
42,169
|
|
|
|
15,365
|
|
Impairment of intangible asset
|
|
|
|
-
|
|
|
|
8,050
|
|
|
|
|
-
|
|
|
|
11,514
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
545,927
|
|
|
|
346,342
|
|
|
|
|
1,834,287
|
|
|
|
1,191,165
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
|
97,314
|
|
|
|
203,695
|
|
|
|
|
536,671
|
|
|
|
868,706
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income and expense:
|
|
|
|
|
|
|
|
|
|
|
Investment income
|
|
|
|
1,442
|
|
|
|
2,196
|
|
|
|
|
8,519
|
|
|
|
8,373
|
|
Interest expense
|
|
|
|
(23,151
|
)
|
|
|
(549
|
)
|
|
|
|
(47,744
|
)
|
|
|
(2,982
|
)
|
Foreign currency gain (loss)
|
|
|
|
(1,059
|
)
|
|
|
(1
|
)
|
|
|
|
696
|
|
|
|
(1,990
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
|
74,546
|
|
|
|
205,341
|
|
|
|
|
498,142
|
|
|
|
872,107
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
|
|
7,942
|
|
|
|
52,009
|
|
|
|
|
353,757
|
|
|
|
215,195
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
$
|
66,604
|
|
|
$
|
153,332
|
|
|
|
$
|
144,385
|
|
|
$
|
656,912
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
0.30
|
|
|
$
|
0.77
|
|
|
|
$
|
0.68
|
|
|
$
|
3.32
|
|
Diluted
|
|
|
$
|
0.29
|
|
|
$
|
0.76
|
|
|
|
$
|
0.67
|
|
|
$
|
3.26
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing earnings per common share
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
225,472
|
|
|
|
198,676
|
|
|
|
|
213,431
|
|
|
|
198,103
|
|
Diluted
|
|
|
|
227,967
|
|
|
|
201,732
|
|
|
|
|
215,933
|
|
|
|
201,623
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
|
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS
|
|
|
(in thousands, except per share amounts)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Twelve months ended
|
|
|
|
|
|
December 31
|
|
|
December 31
|
|
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income
|
|
|
$
|
66,604
|
|
|
$
|
153,332
|
|
|
|
$
|
144,385
|
|
|
$
|
656,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
66,280
|
|
|
|
33,840
|
|
|
|
|
227,133
|
|
|
|
114,461
|
|
|
|
Fair value adjustment of inventory acquired (1)
|
|
|
|
91
|
|
|
|
-
|
|
|
|
|
91
|
|
|
|
-
|
|
|
|
Amortization of purchased intangible assets (2)
|
|
|
|
79,976
|
|
|
|
-
|
|
|
|
|
116,584
|
|
|
|
-
|
|
|
|
Change in fair value of contingent consideration
|
|
|
|
18,550
|
|
|
|
10,041
|
|
|
|
|
64,257
|
|
|
|
20,295
|
|
|
|
Acquisition-related costs (3)
|
|
|
|
3,358
|
|
|
|
-
|
|
|
|
|
39,210
|
|
|
|
-
|
|
|
|
Restructuring expenses (4)
|
|
|
|
11,432
|
|
|
|
15,365
|
|
|
|
|
42,169
|
|
|
|
15,365
|
|
|
|
Impairment of intangible asset
|
|
|
|
-
|
|
|
|
8,050
|
|
|
|
|
-
|
|
|
|
11,514
|
|
|
|
Upfront and milestone payments related to license and collaboration
agreements
|
|
|
|
15,500
|
|
|
|
8,000
|
|
|
|
|
129,750
|
|
|
|
109,925
|
|
|
|
Non-cash taxes (5)
|
|
|
|
(1,864
|
)
|
|
|
37,355
|
|
|
|
|
324,978
|
|
|
|
137,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
|
$
|
259,927
|
|
|
$
|
265,983
|
|
|
|
$
|
1,088,557
|
|
|
$
|
1,065,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP earnings per share - diluted
|
|
|
$
|
0.29
|
|
|
$
|
0.76
|
|
|
|
$
|
0.67
|
|
|
$
|
3.26
|
|
|
|
Non-GAAP earnings per share - diluted
|
|
|
$
|
1.13
|
|
|
$
|
1.30
|
|
|
|
$
|
4.99
|
|
|
$
|
5.21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing diluted earnings per share (GAAP)
|
|
|
|
227,967
|
|
|
|
201,732
|
|
|
|
|
215,933
|
|
|
|
201,623
|
|
|
|
Shares used in computing diluted earnings per share (non-GAAP)
|
|
|
|
230,148
|
|
|
|
204,270
|
|
|
|
|
218,251
|
|
|
|
204,459
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP cost of sales
|
|
|
$
|
57,626
|
|
|
$
|
49,439
|
|
|
|
$
|
233,089
|
|
|
$
|
173,862
|
|
|
|
Share-based compensation expense
|
|
|
|
(2,407
|
)
|
|
|
(1,268
|
)
|
|
|
|
(6,630
|
)
|
|
|
(4,174
|
)
|
|
|
Fair value adjustment of inventory acquired (1)
|
|
|
|
(91
|
)
|
|
|
-
|
|
|
|
|
(91
|
)
|
|
|
-
|
|
|
|
Non-GAAP cost of sales
|
|
|
$
|
55,128
|
|
|
$
|
48,171
|
|
|
|
$
|
226,368
|
|
|
$
|
169,688
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expense reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP research and development expense
|
|
|
$
|
191,035
|
|
|
$
|
129,110
|
|
|
|
$
|
709,472
|
|
|
$
|
513,782
|
|
|
|
Share-based compensation expense
|
|
|
|
(20,735
|
)
|
|
|
(12,829
|
)
|
|
|
|
(64,235
|
)
|
|
|
(36,203
|
)
|
|
|
Upfront and milestone payments related to license and collaboration
agreements
|
|
|
|
(15,500
|
)
|
|
|
(8,000
|
)
|
|
|
|
(129,750
|
)
|
|
|
(109,925
|
)
|
|
|
Non-GAAP research and development expense
|
|
|
$
|
154,800
|
|
|
$
|
108,281
|
|
|
|
$
|
515,487
|
|
|
$
|
367,654
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expense reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP selling, general and administrative expense
|
|
|
$
|
241,576
|
|
|
$
|
183,776
|
|
|
|
$
|
862,595
|
|
|
$
|
630,209
|
|
|
|
Share-based compensation expense
|
|
|
|
(43,138
|
)
|
|
|
(19,743
|
)
|
|
|
|
(156,268
|
)
|
|
|
(74,084
|
)
|
|
|
Non-GAAP selling, general and administrative expense
|
|
|
$
|
198,438
|
|
|
$
|
164,033
|
|
|
|
$
|
706,327
|
|
|
$
|
556,125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income tax provision
|
|
|
$
|
7,942
|
|
|
$
|
52,009
|
|
|
|
$
|
353,757
|
|
|
$
|
215,195
|
|
|
|
Non-cash taxes (5)
|
|
|
|
1,864
|
|
|
|
(37,355
|
)
|
|
|
|
(324,978
|
)
|
|
|
(137,449
|
)
|
|
|
Non-GAAP income tax provision
|
|
|
$
|
9,806
|
|
|
$
|
14,654
|
|
|
|
$
|
28,779
|
|
|
$
|
77,746
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Inventory fair value adjustment associated with the amortization
of Kanuma inventory step-up related to the purchase accounting for
Synageva.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)
|
|
In the third quarter, the Company initiated amortization of its
purchased intangible assets due to the regulatory approvals for
Strensiq and Kanuma.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3)
|
|
The following table summarizes acquisition-related costs:
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Twelve months ended
|
|
|
|
|
|
December 31
|
|
|
December 31
|
|
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
Acquisition-related costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaction costs
|
|
|
$
|
156
|
|
|
$
|
-
|
|
|
|
$
|
26,955
|
|
|
$
|
-
|
|
|
|
Integration costs
|
|
|
|
3,202
|
|
|
|
-
|
|
|
|
|
12,255
|
|
|
|
-
|
|
|
|
|
|
|
$
|
3,358
|
|
|
$
|
-
|
|
|
|
$
|
39,210
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4)
|
|
In the fourth quarter 2015, restructuring expenses includes $11.2
million related to exit costs associated with the US headquarters
relocation to New Haven, CT. During the twelve months ended
December 31, 2015 restructuring expenses of $42.2 million includes
$17.6 million related to the European headquarters relocation,
$13.4 million resulting from the acquisition of Synageva, and
$11.2 million related to exit costs associated with the US
headquarters relocation to New Haven, CT.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5)
|
|
Non-cash taxes represents the adjustment from GAAP tax expense to
the amount of taxes that are payable in cash in the current
period. In the third quarter 2015, the Company recorded a $315.6
million GAAP income tax expense resulting from a non-cash deferred
income tax expense from the integration of Synageva. The deferred
income tax expense resulted from the integration of Synageva
assets into our captive partnership.
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
REVENUES
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Twelve months ended
|
|
|
|
|
|
December 31
|
|
|
December 31
|
|
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soliris (1)
|
|
|
$
|
688,477
|
|
$
|
599,476
|
|
|
$
|
2,590,197
|
|
$
|
2,233,733
|
|
|
Strensiq
|
|
|
|
11,612
|
|
|
-
|
|
|
|
11,969
|
|
|
-
|
|
|
Kanuma
|
|
|
|
336
|
|
|
-
|
|
|
|
366
|
|
|
-
|
|
|
Total net product revenues
|
|
|
|
700,425
|
|
|
599,476
|
|
|
|
2,602,532
|
|
|
2,233,733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty revenue
|
|
|
|
442
|
|
|
-
|
|
|
|
1,515
|
|
|
-
|
|
|
Total other revenue
|
|
|
|
442
|
|
|
-
|
|
|
|
1,515
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
$
|
700,867
|
|
$
|
599,476
|
|
|
$
|
2,604,047
|
|
$
|
2,233,733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Included within the Soliris revenues for the twelve months ended
December 31, 2014 is a reimbursement of $88 million for shipments
made in years prior to January 1, 2014 as a result of an agreement
with the French government.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
|
NET PRODUCT REVENUES GEOGRAPHY
|
|
|
(in thousands)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Twelve months ended
|
|
|
|
|
|
December 31
|
|
|
December 31
|
|
|
|
|
|
2015
|
|
2014
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
$
|
272,725
|
|
$
|
212,966
|
|
|
$
|
951,307
|
|
$
|
730,089
|
|
|
Europe (1)
|
|
|
|
221,622
|
|
|
197,644
|
|
|
|
840,465
|
|
|
836,134
|
|
|
Asia-Pacific
|
|
|
|
73,360
|
|
|
65,562
|
|
|
|
276,350
|
|
|
244,059
|
|
|
Other
|
|
|
|
132,718
|
|
|
123,304
|
|
|
|
534,410
|
|
|
423,451
|
|
|
Total net product revenues
|
|
|
$
|
700,425
|
|
$
|
599,476
|
|
|
$
|
2,602,532
|
|
$
|
2,233,733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Included within the Europe revenues for the twelve months ended
December 31, 2014 is a reimbursement of $88 million for shipments
made in years prior to January 1, 2014 as a result of an agreement
with the French government.
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2015
|
|
|
2014
|
Cash and cash equivalents
|
|
|
$
|
1,010,111
|
|
|
$
|
943,999
|
Marketable securities
|
|
|
|
374,904
|
|
|
|
1,017,567
|
Trade accounts receivable, net
|
|
|
|
532,832
|
|
|
|
432,888
|
Inventories
|
|
|
|
289,874
|
|
|
|
176,441
|
Prepaid expenses and other current assets
|
|
|
|
217,628
|
|
|
|
225,134
|
Property, plant and equipment, net
|
|
|
|
697,025
|
|
|
|
392,248
|
Intangible assets, net
|
|
|
|
4,707,914
|
|
|
|
587,046
|
Goodwill
|
|
|
|
5,047,885
|
|
|
|
254,073
|
Other assets
|
|
|
|
255,057
|
|
|
|
172,566
|
Total assets
|
|
|
$
|
13,133,230
|
|
|
$
|
4,201,962
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
$
|
460,708
|
|
|
$
|
439,248
|
Deferred revenue
|
|
|
|
20,504
|
|
|
|
58,837
|
Current portion of long-term debt
|
|
|
|
175,000
|
|
|
|
48,000
|
Other current liabilities
|
|
|
|
62,038
|
|
|
|
60,655
|
Long-term debt, less current portion
|
|
|
|
3,281,250
|
|
|
|
9,500
|
Contingent consideration
|
|
|
|
121,424
|
|
|
|
116,425
|
Facility lease obligation
|
|
|
|
151,307
|
|
|
|
107,099
|
Deferred tax liabilities
|
|
|
|
528,990
|
|
|
|
7,046
|
Other liabilities
|
|
|
|
73,393
|
|
|
|
53,134
|
Total liabilities
|
|
|
|
4,874,614
|
|
|
|
899,944
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
|
8,258,616
|
|
|
|
3,302,018
|
Total liabilities and stockholders' equity
|
|
|
$
|
13,133,230
|
|
|
$
|
4,201,962
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160203005457/en/
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