[July 28, 2016] |
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Alexion Reports Second Quarter 2016 Results
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial
results for the second quarter of 2016. Total revenues grew to $753
million, an 18 percent increase, compared to $636 million for the same
period in 2015. In the second quarter, the negative impact of currency
on total revenue was 3 percent or $18 million, net of hedging
activities, compared to the same quarter last year. On a GAAP basis,
diluted earnings per share (EPS) for the second quarter of 2016 was
$0.51 per share, compared to $0.83 per share in the second quarter of
2015. Non-GAAP diluted EPS for the second quarter 2016 was $1.13 per
share, reflecting a reduction of $0.12 per share attributable to the
modification of reported non-GAAP income tax expense; prior to this
modification non-GAAP diluted EPS would have been reported at $1.25 per
share (Table 2). Non-GAAP diluted EPS was $1.30 per share in the second
quarter 2015, reflecting a reduction of $0.14 per share attributable to
the tax modification.
Alexion has modified the definition of its non-GAAP income tax expense
to align with the Compliance & Disclosure Interpretations (C&DIs) issued
by the U.S. Securities and Exchange Commission (SEC) on May 17, 2016,
and has reflected this modification in 2015 and 2016 non-GAAP interim
period results. Alexion's modified definition no longer includes the
cash tax benefits the Company realizes during the year from net
operating losses and income tax credits, and now includes other deferred
taxes. The modification does not change the amount of cash taxes the
Company will pay in 2016, or in the future, or have any impact on cash
flow. A reconciliation of GAAP to non-GAAP financial results (Table 2)
and supplemental effective tax rate information for financial guidance
(Table 6) are provided later in the press release.
"In Q2 2016, we delivered strong financial performance as we served an
increasing number of patients with PNH, aHUS, HPP and LAL-D. We are
pleased with the sustained growth in our core Soliris business, the
strong launch of Strensiq, and the continued progress with our Kanuma
launch," said David Hallal, Chief Executive Officer of Alexion. "In the
second half of 2016, we will continue to leverage our rare disease
expertise to reach more patients with Soliris, Strensiq and Kanuma while
advancing multiple milestones in our robust pipeline."
Second Quarter 2016 Financial Highlights
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Soliris® (eculizumab) net product sales were $701 million,
compared to $636 million in Q2 2015, representing a 10 percent
increase. Soliris volume increased 15 percent year-on-year.
-
Strensiq® (asfotase alfa) net product sales were $45
million.
-
Kanuma® (sebelipase alfa) net product sales were $6 million.
-
GAAP R&D expense was $179 million, compared to $132 million in the
same quarter last year. Non-GAAP R&D expense was $165 million,
compared to $117 million in the same quarter last year.
-
GAAP SG&A expense was $232 million, compared to $221 million in the
same quarter last year. Non-GAAP SG&A expense was $200 million,
compared to $169 million in the same quarter last year.
-
GAAP diluted EPS was $0.51 per share, compared to $0.83 per share in
the same quarter last year. Non-GAAP diluted EPS was $1.13 per share,
reflecting a reduction of $0.12 per share attributable to the
modification of reported non-GAAP income tax expense, compared to
$1.30 per share, reflecting a reduction of $0.14 per share
attributable to the modification of non-GAAP income tax expense in the
same quarter last year. GAAP and non-GAAP EPS in the second quarter of
2016 includes the impact of a full quarter of Synageva operations,
shares issued for the acquisition and interest expense on related
borrowings.
Product and Pipeline Updates
Complement Portfolio
-
Eculizumab- Refractory Generalized Myasthenia Gravis (gMG): Data
from the REGAIN study, a single, multinational, placebo-controlled
Phase 3 trial of eculizumab in patients with refractory gMG, were
presented at the International Congress on Neuromuscular Diseases
(ICNMD) meeting. Alexion expects to provide an update on discussions
with regulators by the end of the year.
-
Eculizumab- Relapsing Neuromyelitis Optica Spectrum Disorder
(NMOSD): Alexion expects to complete enrollment this year in the
PREVENT study, a single, multinational, placebo-controlled Phase 3
trial of eculizumab in patients with relapsing NMOSD.
-
Eculizumab- Delayed Graft Function (DGF): Enrollment is
complete in the PROTECT study, a single, multinational,
placebo-controlled Phase 3 trial of eculizumab in the prevention of
DGF, and data are expected in the second half of 2016.
-
ALXN1210: New data from the Phase 1/2 study of ALXN1210, a
highly innovative longer-acting C5 antibody, in patients with
paroxysmal nocturnal hemoglobinuria (PNH) were presented at the
European Hematology Association (EHA) Congress. Alexion expects to
present additional PNH data later this year. Alexion also expects to
initiate a clinical program with ALXN1210 in patients with atypical
hemolytic uremic syndrome (aHUS) later this year. The European
Commission granted Orphan Drug Designation (ODD) to ALXN1210 for the
treatment of patients with PNH.
-
ALXN1007: New data from the Phase 2 study of ALXN1007, a
complement inhibitor that targets C5a, in patients with
graft-versus-host disease involving the lower gastrointestinal tract
(GI-GVHD) were presented at EHA and Alexion is now evaluating higher
doses of ALXN1007 in patients with GI-GVHD.
Metabolic Portfolio
-
SBC-103: New Phase 1/2 data of SBC-103, a recombinant form of
the NAGLU enzyme, in patients with mucopolysaccharidosis IIIB, or MPS
IIIB, were presented at the International Symposium on MPS and Related
Diseases meeting. Alexion has now 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 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. A study to characterize
the natural history of MoCD type A was completed in Q2.
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
Alexion is reiterating its total revenue and Soliris guidance ranges
provided on the first quarter of 2016 earnings call on April 28, 2016,
and based on the strength of the Strensiq launch is increasing its
Metabolic revenue guidance to $200 to $220 million. Alexion is
reiterating its non-GAAP operating expense guidance and is updating its
non-GAAP tax rate and non-GAAP EPS guidance. Alexion is also issuing
2016 GAAP financial guidance.
2016 financial guidance is as follows:
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GAAP Guidance
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Updated Non-GAAP Guidance
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Prior Non-GAAP Guidance
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Total revenues
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$3,050 to $3,100 million
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$3,050 to $3,100 million
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Low end of $3,050 to $3,100 million
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Soliris revenues
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$2,835 to $2,875 million
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$2,835 to $2,875 million
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$2,835 to $2,875 million
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Metabolic revenues
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$200 to $220 million
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$200 to $220 million
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$180 to $200 million
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Cost of sales
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8% to 9%
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8% to 9%
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8% to 9%
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Research and development expense
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$708 to $779 million
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High end of $650 to $680 million
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High end of $650 to $680 million
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Selling, general and administrative expense
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$883 to $935 million
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High end of $760 to $790 million
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High end of $760 to $790 million
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Interest expense
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$100 million
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$100 million
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$100 million
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Effective tax rate
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32% to 34%
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15.5% to 16.5% (1)
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7% to 8%
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Earnings per share
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$1.91 to $2.26
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$4.50 to $4.65
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Low end of $5.00 to $5.20
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Diluted shares outstanding
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228 million
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230 million
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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.
(1)
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Alexion has modified the definition of its non-GAAP income tax
expense. The modified definition no longer includes the cash tax
benefits the Company realizes during the year from net operating
losses and income tax credits, and now includes other deferred
taxes. The modification does not change the amount of cash taxes
the Company will pay in 2016, or in the future, or have any impact
on cash flow. Refer to the reconciliation of GAAP to non-GAAP
financial guidance (Table 3) and the supplemental effective tax
rate information for financial guidance (Table 6) provided later
in the press release.
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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 28, at
10:00 a.m., Eastern Time. To participate in this call, dial 888-505-4328
(USA) or 719-325-2344 (International), passcode 3353485 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 888-203-1112 (USA) or 719-457-0820 (International),
passcode 3353485. 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 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 March 31, 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 six
month periods ended June 30, 2016 and 2015 and projected twelve months
ended December 31, 2016.
(Tables Follow)
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ALEXION PHARMACEUTICALS, INC.
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TABLE 1: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(in thousands, except per share amounts)
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(unaudited)
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Three months ended
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Six months ended
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June 30
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June 30
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2016
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2015
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2016
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2015
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Net product sales
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$
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752,546
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$
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635,983
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$
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1,452,971
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$
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1,236,316
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Other revenue
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|
570
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|
|
|
227
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|
|
|
1,183
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|
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227
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Total revenues
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753,116
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636,210
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1,454,154
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1,236,543
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Cost of sales
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60,627
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52,007
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119,613
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121,406
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Operating expenses:
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Research and development
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179,311
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131,693
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355,601
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352,773
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Selling, general and administrative
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231,802
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221,383
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464,363
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408,499
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Amortization of purchased intangible assets
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80,055
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-
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160,149
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-
|
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Change in fair value of contingent consideration
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5,186
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4,044
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(9,614
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)
|
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16,023
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Acquisition-related costs
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974
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29,777
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2,313
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29,777
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Restructuring expenses
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|
455
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|
|
16,224
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1,177
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23,276
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|
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Total operating expenses
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497,783
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403,121
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973,989
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830,348
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Operating income
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194,706
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181,082
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360,552
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284,789
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Other income and expense:
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Investment income
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1,872
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|
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2,226
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3,423
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5,110
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Interest expense
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(23,793
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)
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(3,971
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)
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|
(47,683
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)
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(4,622
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)
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Foreign currency loss
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(2,820
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)
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(2,045
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)
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(2,729
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)
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(1,040
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)
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Income before income taxes
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169,965
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177,292
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313,563
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|
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284,237
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|
|
|
|
|
|
|
|
|
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Income tax expense
|
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55,022
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|
|
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7,077
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|
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106,454
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22,699
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|
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|
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Net income
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$
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114,943
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|
|
$
|
170,215
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|
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$
|
207,109
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|
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$
|
261,538
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Earnings per common share
|
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|
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Basic
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$
|
0.51
|
|
|
$
|
0.84
|
|
|
$
|
0.92
|
|
|
$
|
1.30
|
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|
Diluted
|
|
$
|
0.51
|
|
|
$
|
0.83
|
|
|
$
|
0.92
|
|
|
$
|
1.29
|
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|
|
|
|
|
|
|
|
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Shares used in computing earnings per common share
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Basic
|
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|
224,089
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|
|
|
202,234
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|
|
|
224,593
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|
|
|
200,806
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|
Diluted
|
|
|
225,756
|
|
|
|
204,546
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|
|
|
226,328
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|
|
|
203,302
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|
|
|
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|
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ALEXION PHARMACEUTICALS, INC.
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TABLE 2: RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS
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(in thousands, except per share amounts)
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(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
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Six months ended
|
|
|
|
June 30
|
|
June 30
|
|
|
|
2016
|
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income
|
|
$
|
114,943
|
|
|
$
|
170,215
|
|
|
$
|
207,109
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|
|
$
|
261,538
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|
|
|
|
|
|
|
|
|
|
|
|
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Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
2,078
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|
|
|
1,344
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|
|
|
5,481
|
|
|
|
2,753
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|
|
Fair value adjustment on inventory acquired (1)
|
|
|
1,326
|
|
|
|
-
|
|
|
|
1,857
|
|
|
|
-
|
|
|
Research and development expense:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
14,394
|
|
|
|
13,329
|
|
|
|
29,579
|
|
|
|
24,413
|
|
|
Upfront and milestone payments related to licenses and collaborations
|
|
-
|
|
|
|
1,750
|
|
|
|
3,050
|
|
|
|
114,250
|
|
|
Selling, general and administrative expense:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
31,507
|
|
|
|
52,327
|
|
|
|
69,808
|
|
|
|
82,631
|
|
|
Amortization of purchased intangible assets (2)
|
|
|
80,055
|
|
|
|
-
|
|
|
|
160,149
|
|
|
|
-
|
|
|
Change in fair value of contingent consideration (3)
|
|
|
5,186
|
|
|
|
4,044
|
|
|
|
(9,614
|
)
|
|
|
16,023
|
|
|
Acquisition-related costs (4)
|
|
|
974
|
|
|
|
29,777
|
|
|
|
2,313
|
|
|
|
29,777
|
|
|
Restructuring expenses
|
|
|
455
|
|
|
|
16,224
|
|
|
|
1,177
|
|
|
|
23,276
|
|
|
Adjustments to income tax expense (5)
|
|
|
6,843
|
|
|
|
(20,172
|
)
|
|
|
14,499
|
|
|
|
(27,880
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
$
|
257,761
|
|
|
$
|
268,838
|
|
|
$
|
485,408
|
|
|
$
|
526,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP earnings per share - diluted
|
|
$
|
0.51
|
|
|
$
|
0.83
|
|
|
$
|
0.92
|
|
|
$
|
1.29
|
|
|
Non-GAAP earnings per share - diluted (6)
|
|
$
|
1.13
|
|
|
$
|
1.30
|
|
|
$
|
2.12
|
|
|
$
|
2.56
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing diluted earnings per share (GAAP)
|
|
225,756
|
|
|
|
204,546
|
|
|
|
226,328
|
|
|
|
203,302
|
|
|
Shares used in computing diluted earnings per share (non-GAAP)
|
|
228,212
|
|
|
|
206,934
|
|
|
|
228,720
|
|
|
|
205,488
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 and Kanuma.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3)
|
In the first quarter of 2016, the Company realized a change in fair
value of contingent consideration due to changes in the likelihood
of payments for contingent consideration associated with our prior
business combinations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4)
|
The following table summarizes acquisition-related costs:
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Six months ended
|
|
|
|
June 30
|
|
June 30
|
|
|
|
2016
|
|
|
2015
|
|
2016
|
|
2015
|
|
Acquisition-related costs:
|
|
|
|
|
|
|
|
|
|
|
Transaction costs
|
|
$
|
-
|
|
|
$
|
26,799
|
|
|
$
|
375
|
|
|
$
|
26,799
|
|
|
Integration costs
|
|
|
974
|
|
|
|
2,978
|
|
|
|
1,938
|
|
|
|
2,978
|
|
|
|
|
$
|
974
|
|
|
$
|
29,777
|
|
|
$
|
2,313
|
|
|
$
|
29,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5)
|
Alexion's modified non-GAAP income tax expense definition includes
the tax effect of pre-tax adjustments to GAAP net income,
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, and share
based compensation deductions not included in GAAP tax expense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6)
|
Alexion has modified its non-GAAP income tax expense definition. The
following table is provided for informational purposes only, during
the period of the modification, and will not be included in future
earnings releases.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Six months ended
|
|
|
|
June 30
|
|
June 30
|
|
|
|
2016
|
|
|
2015
|
|
2016
|
|
|
2015
|
|
Non-GAAP earnings per share - diluted
|
|
$
|
1.13
|
|
|
$
|
1.30
|
|
|
$
|
2.12
|
|
|
$
|
2.56
|
|
|
Reduction attributable to the modified definition of non-GAAP income
tax expense
|
$
|
0.12
|
|
|
$
|
0.14
|
|
|
$
|
0.24
|
|
|
$
|
0.16
|
|
|
|
|
$
|
1.25
|
|
|
$
|
1.44
|
|
|
$
|
2.36
|
|
|
$
|
2.72
|
|
|
|
|
|
|
|
|
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 guidance
|
|
$
|
435
|
|
|
$
|
515
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
Cost of sales:
|
|
|
|
|
|
Share-based compensation
|
|
|
12
|
|
|
|
5
|
|
|
Fair value adjustment on inventory acquired
|
|
|
5
|
|
|
|
2
|
|
|
Research and development expense:
|
|
|
|
|
|
Share-based compensation
|
|
|
73
|
|
|
|
55
|
|
|
Upfront and milestone payments related to licenses and collaborations
|
|
|
26
|
|
|
|
3
|
|
|
Selling, general and administrative expense:
|
|
|
|
|
|
Share-based compensation
|
|
|
145
|
|
|
|
123
|
|
|
Amortization of purchased intangible assets
|
|
|
320
|
|
|
|
320
|
|
|
Change in fair value of contingent consideration
|
|
|
(2
|
)
|
|
|
(2
|
)
|
|
Acquisition-related costs
|
|
|
2
|
|
|
|
2
|
|
|
Restructuring expenses
|
|
|
2
|
|
|
|
1
|
|
|
Adjustments to income tax expense
|
|
|
17
|
|
|
|
46
|
|
|
|
|
|
|
|
|
Non-GAAP net income guidance
|
|
$
|
1,035
|
|
|
$
|
1,070
|
|
|
|
|
|
|
|
|
Diluted GAAP earnings per share
|
|
$
|
1.91
|
|
|
$
|
2.26
|
|
|
Diluted Non-GAAP earnings per share
|
|
$
|
4.50
|
|
|
$
|
4.65
|
|
|
|
|
|
|
|
|
Shares used in computing diluted earnings per share guidance (GAAP)
|
|
|
228
|
|
|
|
228
|
|
|
Shares used in computing diluted earnings per share guidance
(non-GAAP)
|
|
|
230
|
|
|
|
230
|
|
|
|
|
|
|
|
|
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 4: REVENUES
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
Six months ended
|
|
|
|
June 30
|
|
June 30
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Soliris
|
|
$
|
701,009
|
|
$
|
635,983
|
|
$
|
1,365,665
|
|
$
|
1,236,316
|
|
Strensiq
|
|
|
45,141
|
|
|
-
|
|
|
78,383
|
|
|
-
|
|
Kanuma
|
|
|
6,396
|
|
|
-
|
|
|
8,923
|
|
|
-
|
|
Total net product sales
|
|
|
752,546
|
|
|
635,983
|
|
|
1,452,971
|
|
|
1,236,316
|
|
|
|
|
|
|
|
|
|
|
|
Royalty revenue
|
|
|
570
|
|
|
227
|
|
|
1,183
|
|
|
227
|
|
Total other revenue
|
|
|
570
|
|
|
227
|
|
|
1,183
|
|
|
227
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
753,116
|
|
$
|
636,210
|
|
$
|
1,454,154
|
|
$
|
1,236,543
|
|
|
|
ALEXION PHARMACEUTICALS, INC.
|
|
TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30
|
|
|
December 31
|
|
|
|
2016
|
|
|
2015
|
|
Cash and cash equivalents
|
|
$
|
597,550
|
|
|
$
|
1,010,111
|
|
Marketable securities
|
|
|
582,501
|
|
|
|
374,904
|
|
Trade accounts receivable, net
|
|
|
609,297
|
|
|
|
532,832
|
|
Inventories
|
|
|
329,847
|
|
|
|
289,874
|
|
Prepaid expenses and other current assets
|
|
|
242,014
|
|
|
|
208,993
|
|
Property, plant and equipment, net
|
|
|
825,301
|
|
|
|
697,025
|
|
Intangible assets, net
|
|
|
4,547,762
|
|
|
|
4,707,914
|
|
Goodwill
|
|
|
5,037,444
|
|
|
|
5,047,885
|
|
Other assets
|
|
|
257,631
|
|
|
|
228,343
|
|
Total assets
|
|
$
|
13,029,347
|
|
|
$
|
13,097,881
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
436,267
|
|
|
$
|
460,708
|
|
Deferred revenue
|
|
|
53,422
|
|
|
|
20,504
|
|
Current portion of long-term debt
|
|
|
79,136
|
|
|
|
166,365
|
|
Other current liabilities
|
|
|
89,637
|
|
|
|
62,038
|
|
Long-term debt, less current portion
|
|
|
3,171,092
|
|
|
|
3,254,536
|
|
Facility lease obligation
|
|
|
196,439
|
|
|
|
151,307
|
|
Contingent consideration
|
|
|
109,565
|
|
|
|
121,424
|
|
Deferred tax liabilities
|
|
|
570,074
|
|
|
|
528,990
|
|
Other liabilities
|
|
|
124,376
|
|
|
|
73,393
|
|
Total liabilities
|
|
|
4,830,008
|
|
|
|
4,839,265
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
8,199,339
|
|
|
|
8,258,616
|
|
Total liabilities and stockholders' equity
|
|
$
|
13,029,347
|
|
|
$
|
13,097,881
|
|
ALEXION PHARMACEUTICALS, INC.
|
TABLE 6: SUPPLEMENTAL EFFECTIVE TAX RATE INFORMATION FOR
FINANCIAL GUIDANCE - FOR INFORMATION PURPOSES ONLY
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months ended
|
|
|
|
|
|
December 31, 2016
|
|
|
|
|
|
High
|
|
Low
|
|
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 (1)
|
|
|
(11.0
|
%)
|
|
(11.0
|
%)
|
|
Share-based compensation deductions not included in GAAP tax expense
|
|
|
-
|
|
|
(1.0
|
%)
|
|
Non-GAAP income tax expenses as a percentage of non -GAAP pre-tax
income
|
|
|
16.5
|
%
|
|
15.5
|
%
|
|
|
|
|
|
|
|
|
|
Effect of other tax attributes (2)
|
|
|
(8.5
|
%)
|
|
(8.5
|
%)
|
|
Cash taxes as a percentage of non-GAAP pre-tax income (3)
|
|
|
8.0
|
%
|
|
7.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Primarily related to deferred tax resulting from intercompany
transactions with our captive foreign partnership. This deferred tax
expense is not correlated to income before income taxes and would
become due and payable only upon liquidation of a substantial
portion of our non-US business interests.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)
|
Primarily related to deferred tax expense attributable to the
utilization of acquired Synageva net operating losses and tax
credits. We expect to substantially utilize these losses and credits
prior to the fiscal year ending December 31, 2018.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3)
|
Represents the amount of income taxes accrued during the period that
will be due and payable in cash in connection with Alexion's income
tax returns for the period as a percentage of non-GAAP pre-tax
income.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160728005513/en/
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