| [October 27, 2016] |
 |
Alexion Reports Third Quarter 2016 Results
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial
results for the third quarter of 2016. Total revenues grew to $799
million, a 20 percent increase, compared to $667 million for the same
period in 2015. In the third quarter, the negative impact of foreign
currency on total revenue was 2.5 percent or $16 million, net of hedging
activities, compared to the same quarter last year. On a GAAP basis,
diluted earnings per share (EPS) for the third quarter of 2016 was $0.42
per share, compared to a loss of $0.81 per share in the third quarter of
2015. Non-GAAP diluted EPS for the third quarter of 2016 was $1.23 per
share. Non-GAAP diluted EPS was $1.08 per share in the third quarter of
2015, reflecting a reduction of $0.08 per share to conform to the
current non-GAAP income tax expense definition.
"In Q3 2016, we delivered strong financial performance and served an
increasing number of patients with PNH, aHUS, HPP and LAL-D, while also
achieving significant R&D milestones," said David Hallal, Chief
Executive Officer of Alexion. "As we continue to grow our complement and
metabolic businesses, we are working with urgency to file our regulatory
submissions for eculizumab for the treatment of patients with refractory
gMG in both the U.S. and Europe, and to enroll patients with PNH and
aHUS into the global ALXN1210 registration trials."
Third Quarter 2016 Financial Highlights
-
Soliris® (eculizumab) net product sales were $729 million,
compared to $665 million in Q3 2015.
-
Strensiq® (asfotase alfa) net product sales were $61
million.
-
Kanuma® (sebelipase alfa) net product sales were $9 million.
-
GAAP R&D expense was $196 million, compared to $166 million in the
same quarter last year. Non-GAAP R&D expense was $180 million,
compared to $147 million in the same quarter last year.
-
GAAP SG&A expense was $230 million, compared to $213 million in the
same quarter last year. Non-GAAP SG&A expense was $201 million,
compared to $182 million in the same quarter last year.
-
GAAP diluted EPS was $0.42 per share, compared to a loss of $0.81 per
share in the same quarter last year. Non-GAAP diluted EPS was $1.23
per share. Non-GAAP diluted EPS was $1.08 per share in the third
quarter of 2015, reflecting a reduction of $0.08 per share to conform
to the current non-GAAP income tax expense definition.
Product and Pipeline Updates
Complement Portfolio
-
Eculizumab- Refractory Generalized Myasthenia Gravis (gMG): Alexion
plans to file regulatory submissions for eculizumab for the treatment
of patients with refractory gMG in both the United States and Europe
in the first quarter of 2017.
-
Eculizumab- Relapsing Neuromyelitis Optica Spectrum Disorder
(NMOSD): The PREVENT study, a single, multinational,
placebo-controlled registration trial of eculizumab in patients with
relapsing NMOSD is on-going, with data expected in 2017.
-
Eculizumab- Delayed Graft Function (DGF): Data from the
PROTECT study, a single, multinational, placebo-controlled
registration trial of eculizumab in the prevention of DGF, are
expected during the fourth quarter of 2016.
-
ALXN1210- PNH: Alexion has initiated a PNH registration trial
of ALXN1210 administered intravenously every eight weeks. Enrollment
is expected to begin in the fourth quarter of 2016.
-
ALXN1210- aHUS: Alexion has initiated an aHUS registration
trial with ALXN1210 administered intravenously every eight weeks.
Enrollment is expected to begin in the fourth quarter of 2016.
-
ALXN1210- Subcutaneous: Alexion has commenced dosing of a new
formulation of ALXN1210 administered subcutaneously in healthy
volunteers in a Phase I study.
-
ALXN1007: Alexion is evaluating higher doses of ALXN1007, a
complement inhibitor that targets C5a, in a Phase 2 study of patients
with graft-versus-host disease involving the lower gastrointestinal
tract (GI-GVHD). The FDA and the European Commission granted orphan
drug designation to ALXN1007 for the treatment of patients with GVHD.
Metabolic Portfolio
-
SBC-103: A Phase 1/2 study of SBC-103, a recombinant form of
the NAGLU enzyme, in patients with mucopolysaccharidosis IIIB, or MPS
IIIB, is on-going. Alexion has completed the planned dose escalation,
with all patients now randomized to either a 5 mg/kg or 10 mg/kg dose.
A natural history study to characterize the course of disease
progression in patients with MPS IIIB is also ongoing.
-
cPMP Replacement Therapy (ALXN1101): Alexion is enrolling
patients in a pivotal study to evaluate ALXN1101 in neonates with
Molybdenum Cofactor Deficiency (MoCD) Type A.
Immuno-Oncology Program
-
Samalizumab (ALXN6000): Samalizumab is a first-in-class
immunomodulatory humanized monoclonal antibody that blocks the key
immune checkpoint protein, CD200. The Leukemia and Lymphoma Society
announced the BEAT AML Master Trial, a multi-arm clinical trial in
acute myeloid leukemia (AML), which will evaluate samalizumab as well
as other potential therapies for the treatment of AML.
Preclinical Portfolio
-
Alexion has more than 30 diverse preclinical programs across a range
of therapeutic modalities.
2016 Financial Guidance
Alexion expects 2016 total revenues to be at the upper end of our
previously guided range of $3.05 to $3.10 billion. Alexion is
reiterating its Soliris revenue guidance and based on the strength of
the Strensiq launch is further increasing its Metabolic revenue guidance
to $225 to $235 million.
R&D and SG&A expense guidance has been increased to reflect acceleration
of the ALXN1210 programs and additional investment in the global
infrastructure to support the launches of Strensiq and Kanuma, as well
as an increase in legal expenses.
Alexion's updated 2016 GAAP EPS guidance is expected to be in the range
of $1.79 to $2.09 and non-GAAP EPS guidance is now expected to be at the
upper end of the previously guided range of $4.50 to $4.65 per share.
Updated 2016 financial guidance is as follows:
|
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Updated GAAP
|
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|
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|
Updated Non-GAAP
|
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Prior Non-GAAP
|
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|
|
Guidance
|
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|
Prior GAAP Guidance
|
|
|
Guidance
|
|
|
Guidance
|
|
Total revenues
|
|
Upper end of $3,050 to $3,100 million
|
|
|
$3,050 to $3,100 million
|
|
|
Upper end of $3,050 to $3,100 million
|
|
|
$3,050 to $3,100 million
|
|
Soliris revenues
|
|
$2,835 to $2,875 million
|
|
|
$2,835 to $2,875 million
|
|
|
$2,835 to $2,875 million
|
|
|
$2,835 to $2,875 million
|
|
Metabolic revenues
|
|
$225 to $235 million
|
|
|
$200 to $220 million
|
|
|
$225 to $235 million
|
|
|
$200 to $220 million
|
|
Cost of sales
|
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8% to 9%
|
|
|
8% to 9%
|
|
|
8% to 9%
|
|
|
8% to 9%
|
|
Research and development expense
|
|
$740 to $781 million
|
|
|
$708 to $779 million
|
|
|
$680 to $690 million
|
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|
High end of $650 to $680 million
|
|
Selling, general and administrative expense
|
|
$913 to $955 million
|
|
|
$883 to $935 million
|
|
|
$790 to $810 million
|
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|
High end of $760 to $790 million
|
|
Interest expense
|
|
$100 million
|
|
|
$100 million
|
|
|
$100 million
|
|
|
$100 million
|
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Effective tax rate
|
|
32% to 34%
|
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|
32% to 34%
|
|
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15.5% to 16.5%
|
|
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15.5% to 16.5%
|
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Earnings per share
|
|
$1.79 to $2.09
|
|
|
$1.91 to $2.26
|
|
|
Upper end of $4.50 to $4.65
|
|
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$4.50 to $4.65
|
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Diluted shares outstanding
|
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228 million
|
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228 million
|
|
|
230 million
|
|
|
230 million
|
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Alexion's 2016 financial guidance is based on current foreign exchange
rates net of hedging activities and does not include the effect of
business combinations, license and collaboration agreements, asset
acquisitions, intangible asset impairments, changes in fair value of
contingent consideration or restructuring activity that may occur after
the day prior to the date of this press release.
Conference Call/Webcast Information:
Alexion will host a conference call/audio webcast to discuss its third
quarter 2016 results at 10:00 a.m. Eastern Time. To participate in this
call, dial 888-487-0355 (USA) or 719-325-2123 (International), passcode
9676571 shortly before 10:00 a.m. Eastern Time. A replay of the call
will be available for a limited period following the call. The replay
number is 888-203-1112 (USA) or 719-457-0820 (International), passcode
9676571. The audio webcast can be accessed on the Investor page of
Alexion's website at: 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 press 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 regulatory filings and 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, including for ALXN1210, 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
investigations of Alexion by the SEC and DOJ investigations, the risk
that anticipated regulatory filings are delayed, 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 June 30, 2016 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 press 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, upfront and milestone
payments related to licenses and collaborations and adjustments to
income tax expense. 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 Reconciliations of GAAP to
non-GAAP Financial Results and GAAP to non-GAAP 2016 Financial Guidance
for explanations of the amounts adjusted to arrive at non-GAAP net
income and non-GAAP earnings per share amounts for the three and nine
month periods ended September 30, 2016 and 2015 and projected twelve
months ended December 31, 2016.
(Tables Follow)
|
|
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ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(in thousands, except per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Nine months ended
|
|
|
|
September 30
|
|
September 30
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Net product sales
|
|
$
|
798,524
|
|
|
$
|
665,791
|
|
|
$
|
2,251,495
|
|
|
$
|
1,902,107
|
|
|
Other revenue
|
|
582
|
|
|
846
|
|
|
1,765
|
|
|
1,073
|
|
|
Total revenues
|
|
799,106
|
|
|
666,637
|
|
|
2,253,260
|
|
|
1,903,180
|
|
|
Cost of sales
|
|
71,095
|
|
|
54,057
|
|
|
190,708
|
|
|
175,463
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
195,687
|
|
|
165,664
|
|
|
551,288
|
|
|
518,437
|
|
|
Selling, general and administrative
|
|
230,128
|
|
|
212,520
|
|
|
694,491
|
|
|
621,019
|
|
|
Amortization of purchased intangible assets
|
|
82,036
|
|
|
36,608
|
|
|
242,185
|
|
|
36,608
|
|
|
Change in fair value of contingent consideration
|
|
40,290
|
|
|
29,684
|
|
|
30,676
|
|
|
45,707
|
|
|
Acquisition-related costs
|
|
-
|
|
|
6,075
|
|
|
2,313
|
|
|
35,852
|
|
|
Restructuring expenses
|
|
564
|
|
|
7,461
|
|
|
1,741
|
|
|
30,737
|
|
|
Total operating expenses
|
|
548,705
|
|
|
458,012
|
|
|
1,522,694
|
|
|
1,288,360
|
|
|
Operating income
|
|
179,306
|
|
|
154,568
|
|
|
539,858
|
|
|
439,357
|
|
|
Other income and expense:
|
|
|
|
|
|
|
|
|
|
Investment income
|
|
4,626
|
|
|
1,967
|
|
|
8,049
|
|
|
7,077
|
|
|
Interest expense
|
|
(24,807
|
)
|
|
(19,971
|
)
|
|
(72,490
|
)
|
|
(24,593
|
)
|
|
Foreign currency (loss) gain
|
|
(1,011
|
)
|
|
2,795
|
|
|
(3,740
|
)
|
|
1,755
|
|
|
Income before income taxes
|
|
158,114
|
|
|
139,359
|
|
|
471,677
|
|
|
423,596
|
|
|
Income tax expense
|
|
63,776
|
|
|
323,116
|
|
|
165,113
|
|
|
345,815
|
|
|
Net income (loss)
|
|
$
|
94,338
|
|
|
$
|
(183,757
|
)
|
|
$
|
306,564
|
|
|
$
|
77,781
|
|
|
Earnings (loss) per common share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.42
|
|
|
$
|
(0.81
|
)
|
|
$
|
1.37
|
|
|
$
|
0.37
|
|
|
Diluted
|
|
$
|
0.42
|
|
|
$
|
(0.81
|
)
|
|
$
|
1.35
|
|
|
$
|
0.37
|
|
|
Shares used in computing earnings per common share
|
|
|
|
|
|
|
|
|
Basic
|
|
224,180
|
|
|
226,228
|
|
|
224,454
|
|
|
209,373
|
|
|
Diluted
|
|
226,088
|
|
|
226,228
|
|
|
226,560
|
|
|
211,808
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
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TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS
|
|
(in thousands, except per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Nine Months Ended
|
|
|
|
|
September 30
|
|
September 30
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$
|
94,338
|
|
$
|
(183,757
|
)
|
|
$
|
306,564
|
|
$
|
77,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
2,704
|
|
|
1,470
|
|
|
|
8,185
|
|
|
4,223
|
|
|
Fair value adjustment in inventory acquired (1)
|
|
|
6,585
|
|
|
-
|
|
|
|
8,442
|
|
|
-
|
|
|
Research and development expense:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
14,232
|
|
|
19,087
|
|
|
|
43,811
|
|
|
43,500
|
|
|
Upfront and milestone payments related to licenses and collaborations
|
|
|
1,489
|
|
|
-
|
|
|
|
4,539
|
|
|
114,250
|
|
|
Selling, general and administrative expense:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
29,405
|
|
|
30,499
|
|
|
|
99,213
|
|
|
113,130
|
|
|
Amortization of purchased intangible assets (2)
|
|
|
82,036
|
|
|
36,608
|
|
|
|
242,185
|
|
|
36,608
|
|
|
Change in fair value of contingent consideration
|
|
|
40,290
|
|
|
29,684
|
|
|
|
30,676
|
|
|
45,707
|
|
|
Acquisition-related costs (3)
|
|
|
-
|
|
|
6,075
|
|
|
|
2,313
|
|
|
35,852
|
|
|
Restructuring expenses
|
|
|
564
|
|
|
7,461
|
|
|
|
1,741
|
|
|
30,737
|
|
|
Adjustments to income tax expense (4) (5)
|
|
|
9,660
|
|
|
302,244
|
|
|
|
19,042
|
|
|
274,363
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
$
|
281,303
|
|
$
|
249,371
|
|
|
$
|
766,711
|
|
$
|
776,151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP earnings (loss) per share - diluted
|
|
$
|
0.42
|
|
$
|
(0.81
|
)
|
|
$
|
1.35
|
|
$
|
0.37
|
|
|
Non-GAAP earnings per share - diluted (5)
|
|
$
|
1.23
|
|
$
|
1.08
|
|
|
$
|
3.36
|
|
$
|
3.62
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing diluted earnings per share (GAAP)
|
|
|
226,088
|
|
|
226,228
|
|
|
|
226,560
|
|
|
211,808
|
|
|
Shares used in computing diluted earnings per share (non-GAAP)
|
|
|
228,008
|
|
|
230,875
|
|
|
|
228,464
|
|
|
214,146
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 of 2015, the Company initiated
amortization of its purchased intangible assets due to the
regulatory approvals for Strensiq & Kanuma.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) The following table summarizes acquisition related costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Nine Months Ended
|
|
|
|
|
September 30
|
|
September 30
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
Acquisition-related costs:
|
|
|
|
|
|
|
|
|
|
|
Transaction costs
|
|
$
|
-
|
|
$
|
-
|
|
|
$
|
375
|
|
$
|
26,799
|
|
|
Integration costs
|
|
|
-
|
|
|
6,075
|
|
|
|
1,938
|
|
|
9,053
|
|
|
|
|
$
|
-
|
|
$
|
6,075
|
|
|
$
|
2,313
|
|
$
|
35,852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4) Alexion's non-GAAP income tax expense definition excludes the
tax effect of pre-tax adjustments to GAAP net income and
intercompany transactions with our captive foreign partnership
which would become due and payable only upon liquidation of a
substantial portion of our non-US business interests.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5) Previously reported non-GAAP tax expense and diluted EPS have
been modified to conform to the current non-GAAP income tax
definition adopted in Q2 2016. Previously reported non-GAAP EPS
was $1.16 and $3.87 for the three and nine months ended September
30, 2015, respectively.
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 3: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL GUIDANCE
|
|
(in millions, except per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
Twelve months ended
|
|
|
|
December 31 2016
|
|
|
|
Low
|
|
High
|
|
GAAP net income
|
|
$
|
408
|
|
|
$
|
477
|
|
Before tax adjustments:
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
|
Share-based compensation
|
|
12
|
|
|
10
|
|
Fair value adjustment in inventory acquired
|
|
12
|
|
|
10
|
|
Research and development expense:
|
|
|
|
|
|
Share-based compensation
|
|
65
|
|
|
55
|
|
Upfront and milestone payments related to licenses and collaborations
|
|
26
|
|
|
5
|
|
Selling, general and administrative expense:
|
|
|
|
|
|
Share-based compensation
|
|
145
|
|
|
123
|
|
Amortization of purchased intangible assets
|
|
322
|
|
|
322
|
|
Change in fair value of contingent consideration
|
|
36
|
|
|
36
|
|
Acquisition-related costs
|
|
2
|
|
|
2
|
|
Restructuring expenses
|
|
2
|
|
|
2
|
|
Adjustments to income tax expense
|
|
5
|
|
|
28
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
$
|
1,035
|
|
|
$
|
1,070
|
|
|
|
|
|
|
|
Diluted GAAP earnings per share
|
|
$
|
1.79
|
|
|
$
|
2.09
|
|
Diluted Non-GAAP earnings per share
|
|
$
|
4.50
|
|
|
$
|
4.65
|
|
|
|
|
|
|
|
Shares used in computing diluted earnings per share (GAAP)
|
|
228
|
|
|
228
|
|
Shares used in computing diluted earnings per share (non-GAAP)
|
|
230
|
|
|
230
|
|
|
|
|
|
|
|
Twelve months ended
|
|
|
|
December 31 2016
|
|
|
|
Low
|
|
High
|
|
GAAP income tax expense as a percentage of GAAP pre-tax income
|
|
34
|
%
|
|
32
|
%
|
|
Tax effect of pre-tax adjustments to GAAP net income
|
|
(6.5
|
%)
|
|
(4.5
|
%)
|
|
Tax effect of intercompany transactions
|
|
(11.0
|
%)
|
|
(12.0
|
%)
|
|
Non-GAAP income tax expenses as a percentage of non-GAAP pre-tax
income
|
|
16.5
|
%
|
|
15.5
|
%
|
|
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 4: REVENUES
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Nine months ended
|
|
|
|
|
|
September 30
|
|
September 30
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Soliris
|
|
|
|
$
|
728,851
|
|
|
$
|
665,404
|
|
|
$
|
2,094,516
|
|
|
$
|
1,901,720
|
|
Strensiq
|
|
|
|
60,531
|
|
|
357
|
|
|
138,914
|
|
|
357
|
|
Kanuma
|
|
|
|
9,142
|
|
|
30
|
|
|
18,065
|
|
|
30
|
|
Total net product sales
|
|
|
|
798,524
|
|
|
665,791
|
|
|
2,251,495
|
|
|
1,902,107
|
|
Royalty revenue
|
|
|
|
582
|
|
|
846
|
|
|
1,765
|
|
|
1,073
|
|
Total other revenue
|
|
|
|
582
|
|
|
846
|
|
|
1,765
|
|
|
1,073
|
|
Total revenues
|
|
|
|
$
|
799,106
|
|
|
$
|
666,637
|
|
|
$
|
2,253,260
|
|
|
$
|
1,903,180
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2016
|
|
2015
|
|
Cash and cash equivalents
|
|
$
|
761,989
|
|
|
$
|
1,010,111
|
|
Marketable securities
|
|
550,882
|
|
|
374,904
|
|
Trade accounts receivable, net
|
|
676,837
|
|
|
532,832
|
|
Inventories
|
|
363,058
|
|
|
289,874
|
|
Prepaid expenses and other current assets
|
|
241,768
|
|
|
208,993
|
|
Property, plant and equipment, net
|
|
931,060
|
|
|
697,025
|
|
Intangible assets, net
|
|
4,467,726
|
|
|
4,707,914
|
|
Goodwill
|
|
5,037,444
|
|
|
5,047,885
|
|
Other assets
|
|
262,698
|
|
|
228,343
|
|
Total assets
|
|
$
|
13,293,462
|
|
|
$
|
13,097,881
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
530,083
|
|
|
$
|
460,708
|
|
Deferred revenue
|
|
63,402
|
|
|
20,504
|
|
Current portion of long-term debt
|
|
122,942
|
|
|
166,365
|
|
Other current liabilities
|
|
36,066
|
|
|
6,234
|
|
Current portion of contingent consideration
|
|
81,848
|
|
|
55,804
|
|
Long-term debt, less current portion
|
|
3,129,384
|
|
|
3,254,536
|
|
Facility lease obligation
|
|
224,442
|
|
|
151,307
|
|
Contingent consideration
|
|
126,056
|
|
|
121,424
|
|
Deferred tax liabilities (1)
|
|
343,794
|
|
|
528,990
|
|
Other liabilities
|
|
131,342
|
|
|
73,393
|
|
Total liabilities
|
|
4,789,359
|
|
|
4,839,265
|
|
Total stockholders' equity (1)
|
|
8,504,103
|
|
|
8,258,616
|
|
Total liabilities and stockholders' equity
|
|
$
|
13,293,462
|
|
|
$
|
13,097,881
|
|
|
|
|
|
|
|
|
|
|
(1) In March 2016, the FASB issued a new standard intended to
simplify certain aspects of the accounting for employee
share-based payments. We elected to early adopt this standard
during the third quarter of 2016. The adoption of the new standard
requires recognition of excess tax benefits regardless of whether
the benefit reduces taxes payable in the current period. As a
result, $237,850 associated with previously unrecognized excess
tax benefits was recorded as a deferred tax asset and an increase
in retained earnings as of the beginning of 2016.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20161027005458/en/
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