[January 25, 2018] |
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Celgene Reports Fourth Quarter and Full-Year 2017 Operating and Financial Results
Celgene Corporation (NASDAQ:CELG) reported operating results for the
fourth quarter and full year of 2017. For the fourth quarter of 2017,
net product sales were $3,479 million, an increase of 17 percent,
year-over-year. Fourth quarter total revenue increased 17 percent to
$3,483 million.
Net product sales for the full year of 2017 were $12,973 million, an
increase of 16 percent year-over-year. Total revenue for the full year
of 2017 was $13,003 million, an increase of 16 percent year-over-year.
Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene
reported a net loss of $81 million and diluted earnings per share (EPS)
of ($0.10) for the fourth quarter of 2017. For the fourth quarter of
2016, GAAP net income was $429 million and diluted EPS was $0.53. The
decrease was primarily due to the impact of the Tax Cuts and Jobs Act.
Full-year GAAP net income for 2017 was $2,940 million and diluted EPS
was $3.64. Full-year GAAP net income for 2016 was $1,999 million and
diluted EPS was $2.49.
Adjusted net income for the fourth quarter of 2017 increased 23 percent
to $1,592 million compared to $1,290 million in the fourth quarter of
2016. For the same period, adjusted diluted EPS increased 24 percent to
$2.00 from $1.61.
Adjusted net income for the full year 2017 increased 26 percent to
$6,016 million. Adjusted diluted EPS increased 25 percent to $7.44 from
$5.94 for the full year of 2016.
"Our 2017 commercial, regulatory and clinical execution lay the
foundation for success in 2018 and beyond," said Mark J. Alles, Chief
Executive Officer of Celgene Corporation. "Our operating momentum
enables us to continue expanding our portfolio, as demonstrated by the
two strategic transactions announced this year."
Fourth Quarter and Full-Year 2017 Financial
Highlights
Unless otherwise stated, all comparisons are for the fourth quarter and
full year of 2017 compared to the fourth quarter and full year of 2016.
The adjusted operating expense categories presented below exclude
share-based employee compensation expense, collaboration-related upfront
expense, research and development asset acquisition expense, IPR&D asset
impairment charges, clinical trial and development activity wind-down
costs and a litigation-related loss contingency accrual expense. Please
see the attached Use of Non-GAAP Financial Measures and Reconciliation
of GAAP to Adjusted Net Income for further information relevant to the
interpretation of adjusted financial measures and reconciliations of
these adjusted financial measures to the most comparable GAAP measures,
respectively.
Net Product Sales Performance
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REVLIMID® sales for the fourth quarter increased 21 percent
to $2,188 million. Fourth quarter U.S. sales of $1,473 million and
international sales of $715 million increased 24 percent and 15
percent, respectively. Full-year REVLIMID® sales were
$8,187 million, an increase of 17 percent year-over-year. Sales growth
was driven primarily by higher volume due to increases in duration and
market share.
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POMALYST®/IMNOVID® sales for the fourth quarter
were $442 million, an increase of 17 percent year-over-year. Fourth
quarter U.S. sales of $283 million increased 29 percent and
international sales were unchanged at $159 million. Full-year POMALYST®/IMNOVID®
sales were $1,614 million, an increase of 23% year-over-year. Sales
growth was driven primarily by increased volume due to increases in
market share and duration.
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OTEZLA® sales in the fourth quarter were $371 million, a 22
percent increase year-over-year. Fourth quarter U.S. sales of $303
million and international sales of $68 million increased 13 percent
and 84 percent, respectively. Full-year OTEZLA® sales were
$1,279 million, an increase of 26 percent year-over-year. OTEZLA®
sales were primarily driven by volume gains in the U.S. and strong
uptake in key international markets.
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ABRAXANE® sales for the fourth quarter were $251 million, a
decrease of 6 percent year-over-year. U.S. sales were $155 million and
international sales were $96 million, a decrease of 10 percent and an
increase of 2 percent, respectively. Full-year ABRAXANE®
sales were $992 million, an increase of 2 percent year-over-year.
ABRAXANE® market shares in pancreatic cancer, first-line
advanced non-squamous lung cancer and metastatic breast cancer in the
U.S. have remained stable. Growth in Europe was from market share
gains for ABRAXANE® in pancreatic cancer.
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In the fourth quarter, all other product sales, which include IDHIFA®,
THALOMID®, ISTODAX®, VIDAZA® and an
authorized generic version of VIDAZA® drug product
primarily sold in the U.S., were $227 million compared to $220 million
in the fourth quarter of 2016. Full-year sales for these products were
$901 million compared to $910 million in full-year 2016.
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Total net product sales for the fourth quarter of 2017 increased 17
percent year-over-year, driven by operational growth. Net product
sales growth also includes a 1.4 percent negative impact from currency
exchange effects.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $2,738 million for the fourth quarter
of 2017 versus $1,135 million for the same period in 2016. Full-year
2017 R&D expenses were $5,915 million compared to $4,470 million for
2016. Both the fourth-quarter and full-year 2017 increases in R&D
expenses on a GAAP basis were primarily due to the charges related to
the discontinuation of the GED-0301 clinical trials in Crohn's disease,
including impairment of an IPR&D asset and other one-time charges
related to wind-down costs associated with the GED-0301 clinical trials
in Crohn's disease and certain development activities.
Adjusted R&D expenses were $766 million for the fourth quarter of 2017
compared to $673 million for the fourth quarter of 2016. For the full
year 2017, adjusted R&D expenses were $2,749 million compared to $2,508
million for the full year 2016. Both the fourth quarter and full-year
2017 increases in adjusted R&D expenses were primarily due to increased
spending related to clinical trial and other R&D activity.
Selling, General, and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $774 million for the fourth quarter
of 2017 compared to $685 million for the same period in 2016. Full-year
SG&A expenses were $2,941 million for 2017 compared to $2,658 million
for 2016. The full-year 2017 increase in SG&A expenses was primarily due
to an increase in litigation-related loss contingency accrual expense.
Adjusted SG&A expenses were $687 million for the fourth quarter of 2017
compared to $533 million for the fourth quarter of 2016. For full-year
2017, adjusted SG&A expenses were $2,279 million versus $2,139 million
in 2016.
Cash, Cash Equivalents, and Marketable Securities
Operating cash flow was $5,246 million for 2017, an increase of 26
percent compared to 2016. For the full-year 2017, Celgene purchased
approximately $3,911 million of its common shares. As of December 31,
2017, the Company had $822 million remaining under the existing share
repurchase program. The Company ended the year with $12,042 million in
cash and marketable securities.
Celgene Expects Volume-Driven Product Sales and
Earnings Growth in 2018
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Year-over-Year Change
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Total Revenue
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$14.4B to $14.8B
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12%*
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REVLIMID® Net Product Sales
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Approximately $9.4B
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15%
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POMALYST®/ IMNOVID® Net Product Sales
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Approximately $1.9B
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18%
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OTEZLA® Net Product Sales
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Approximately $1.5B
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17%
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ABRAXANE® Net Product Sales
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Approximately $1.0B
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1%
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GAAP operating margin***
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Approximately 46.5%
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N/M**
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Adjusted operating margin***
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Approximately 60.0%
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~ +200 bps
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Adjusted Tax Rate
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~18%
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~ +210 bps
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GAAP diluted EPS***
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$7.26 to $7.66
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N/M**
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Adjusted diluted EPS***
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$8.70 to $8.90
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18%*
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Weighted average diluted shares
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775M
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-34M
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*Year-over-year percentage change based on the mid-point of the
range.
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**Not meaningful as the 2018 measures exclude the impact of any
strategic transactions, impairments, loss contingencies, changes in
the fair value of equity investments and non-operating tax
adjustments that have not yet occurred.
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*** 2018 guidance does not include the impact of our recently
announced pending acquisition of Juno Therapeutics Inc., which is
expected to be dilutive to adjusted diluted EPS in 2018 by
approximately $0.50.
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Product and Pipeline Updates
Hematology & Oncology
-
At the 59th American Society of Hematology (ASH) Annual Meeting in
December, data were presented on Celgene's marketed and pipeline
hematology assets. Select data presentations included:
-
Celgene and partner bluebird bio presented updated data from the
phase I trial evaluating bb2121 in patients with relapsed and/or
refractory multiple myeloma (RRMM). In November, bb2121 was
granted Breakthrough Therapy Designation (BTD) by the U.S. Food
and Drug Administration (FDA) and PRIority MEdicines (PRIME)
eligibility by the European Medicines Agency (EMA). In December,
the pivotal KarMMa™ trial evaluating bb2121 in RRMM was initiated.
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Celgene and partner Juno Therapeutics presented updated data from
the phase I TRANSCEND trial evaluating JCAR017 in patients with
relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). The
pivotal TRANSCEND program in the U.S. with JCAR017 in diffuse
large B-cell lymphoma (DLBCL) is under way and the TRANSCEND WORLD
cohort is on-track to initiate in the first half of 2018.
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Celgene and partner Acceleron Pharma presented updated data from
the ongoing phase II trials with luspatercept in patients with
lower-risk myelodysplastic syndromes (MDS). Data from the phase
III MEDALIST™ and BELIEVE™ trials are
expected in mid-2018. Additionally, Celgene plans to initiate the
phase III COMMANDS™ trial with luspatercept in
front-line MDS during the first half of 2018.
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Updated data were presented from the phase Ib trial evaluating
CC-122 in combination with obinutuzumab in patients with DLBCL,
follicular lymphoma (FL) or marginal zone lymphoma (MZL). A
pivotal program with CC-122 in NHL is expected to initiate in 2018.
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Updated data were presented from the phase I trial evaluating
CC-486 in combination with rituximab plus chemotherapy (R-CHOP) in
patients with DLBCL, FL or transformed lymphoma. Data from the
phase III QUAZAR® AML-001 trial evaluating CC-486 as
maintenance therapy in post-induction acute myeloid leukemia (AML)
is expected in the second half of 2018.
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Celgene and partner Agios Pharmaceuticals presented data from the
phase I trial evaluating ivosidenib or IDHIFA® combined
with standard induction chemotherapy (7+3 regimen) in patients
with newly diagnosed AML with an isocitrate dehydrogenase-1 (IDH1)
or isocitrate dehydrogenase-2 (IDH2) mutation.
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In December, Celgene disclosed top-line results from the phase III
RELEVANCE® trial evaluating REVLIMID® in
combination with rituximab (R2) in first-line FL. This
investigational study evaluated REVLIMID® plus R2
followed by R2 maintenance compared to the standard of care
with rituximab plus chemotherapy (R-CHOP, R-bendamustine or R-CVP)
followed by rituximab maintenance in patients with previously
untreated FL. The R2 treatment arm did not achieve
superiority in the co-primary endpoints of complete response or
unconfirmed complete response (CR/CRu) at 120 weeks and
progression-free survival (PFS) during the pre-planned analysis (final
analysis of CR/CRu and interim analysis of PFS). Neither arm was
superior for either of the co-primary endpoints. The safety findings
were consistent with the known profiles of the regimens investigated.
The full data set will be presented at a future medical congress.
Inflammation & Immunology
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In December, a New Drug Application (NDA) was submitted with the FDA
for ozanimod in relapsing multiple sclerosis (RMS) based on data from
the phase III RADIANCE™ Part B and SUNBEAM™ trials
evaluating ozanimod in patients with RMS. The data were presented at
the MSParis2017-7th Joint European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS)-American Committee for
Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting in
October. Celgene plans to submit a Marketing Authorization Application
(MAA) with the EMA in the first quarter of 2018.
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A robust life-cycle plan for ozanimod is advancing and a phase III
pivotal trial evaluating ozanimod in Crohn's disease was initiated. In
addition, the phase III TRUE NORTH™ trial with ozanimod in
ulcerative colitis (UC) is ongoing and on-track to complete enrollment
in the second half of 2018.
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In 2018, Celgene plans to initiate a phase III trial with OTEZLA®
in UC based on the efficacy and safety results demonstrated in a phase
II randomized, double-blind, placebo-controlled proof of concept study
evaluating OTEZLA® in UC (n=170). The full phase II data
set will be presented at the 13th Congress of the European Crohn's and
Colitis Organization (ECCO) in February.
Business Update Summary
-
In January 2018, Celgene entered into an agreement to acquire Impact
Biomedicines, Inc., a privately-held biotechnology company developing
fedratinib, a highly selective JAK2 kinase inhibitor, for
myelofibrosis and polycythemia vera.
Under the terms of the
agreement, Celgene will pay approximately $1.1 billion upfront and up
to $1.25 billion in contingent payments based on regulatory approval
milestones for myelofibrosis. Additional future payments for
regulatory approvals in additional indications and sales-based
milestones are also possible. This acquisition will strengthen
Celgene's commitment to myelofibrosis, a disease with high unmet
medical need, and will expand strategic development options within
Celgene's myeloid portfolio of assets. The transaction is expected to
close in the first quarter of 2018.
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In January 2018, Celgene entered into an agreement to acquire Juno
Therapeutics, Inc., an integrated biopharmaceutical company focused on
developing innovative cellular immunotherapies for the treatment of
cancer.
Under the terms of the merger agreement, Celgene
will pay $87 per share in cash, or a total of approximately $9
billion, net of cash and marketable securities acquired and Juno
shares already owned by Celgene (approximately 9.7% of outstanding
shares). Adding to Celgene's lymphoma program, JCAR017 represents a
potentially best-in-class CD19-directed CAR T currently in a pivotal
program for relapsed and/or refractory DLBCL. This acquisition will
complement Celgene's leadership in hematology and oncology as well as
advance Celgene's global leadership in cellular immunotherapy.
The
transaction is subject to customary closing conditions, including the
tender of a number of shares of Juno common stock that represent at
least a majority of outstanding shares, and expiration of the
applicable waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976. Celgene expects to fund the transaction
through a combination of existing cash and new debt. The transaction
is expected to close in the first quarter of 2018.
Q4 and Full-year 2017 Conference Call and Webcast Information
Celgene will host a conference call to discuss the fourth quarter and
full-year of 2017 operational and financial performance on Thursday,
January 25, 2018, at 9 a.m. ET. The conference call will be available by
webcast at www.celgene.com.
An audio replay of the call will be available from noon January 25,
2018, until midnight ET February 1, 2018. To access the replay in the
U.S., dial 1-855-859-2056; outside the U.S. dial 404-537-3406. The
participant passcode is 2175246.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through
next-generation solutions in protein homeostasis, immuno-oncology,
epigenetics, immunology and neuro-inflammation. For more information,
please visit www.celgene.com.
Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
Forward-Looking Statement
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections, and
speak only as of the date they are made. We undertake no obligation to
update any forward-looking statement in light of new information or
future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are
difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the Securities and
Exchange Commission.
The tender offer described herein has not yet commenced. The description
contained herein is for informational purposes only and is not an offer
to buy or the solicitation of an offer to sell any shares of Juno. At
the time the tender offer is commenced, Celgene and Blue Magpie
Corporation ("Purchaser") intend to file with the U.S. Securities and
Exchange Commission (the "SEC") a Tender Offer Statement on Schedule TO
containing an offer to purchase, a form of letter of transmittal and
other documents relating to the tender offer, and Juno intends to file a
Solicitation/Recommendation Statement on Schedule 14D-9 with respect to
the tender offer. Celgene, Purchaser and Juno intend to mail these
documents to the stockholders of Juno. THESE DOCUMENTS, AS EACH MAY BE
AMENDED OR SUPPLEMENTED FROM TIME TO TIME, WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE TENDER OFFER AND JUNO STOCKHOLDERS ARE URGED TO
READ THEM CAREFULLY WHEN THEY BECOME AVAILABLE. STOCKHOLDERS OF JUNO
WILL BE ABLE TO OBTAIN A FREE COPY OF THESE DOCUMENTS (WHEN THEY BECOME
AVAILABLE) AND OTHER DOCUMENTS FILED BY JUNO, CELGENE OR PURCHASER WITH
THE SEC AT THE WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV.
Hyperlinks are provided as a convenience and for informational purposes
only. Celgene bears no responsibility for the security or content of
external websites.
Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S.
GAAP, this document also contains certain non-GAAP financial measures
based on management's view of performance including:
-
Adjusted research and development expense
-
Adjusted selling, general and administrative expense
-
Adjusted operating margin
-
Adjusted net income
-
Adjusted earnings per share
Management uses such measures internally for planning and forecasting
purposes and to measure the performance of the Company. We believe these
adjusted financial measures provide useful and meaningful information to
us and investors because they enhance investors' understanding of the
continuing operating performance of our business and facilitate the
comparison of performance between past and future periods. These
adjusted financial measures are non-GAAP measures and should be
considered in addition to, but not as a substitute for, the information
prepared in accordance with U.S. GAAP. When preparing these supplemental
non-GAAP financial measures we typically exclude certain GAAP items that
management does not consider to be normal, recurring, cash operating
expenses but that may not meet the definition of unusual or
non-recurring items. Other companies may define these measures in
different ways. The following categories of items are excluded from
adjusted financial results:
Acquisition and Divestiture-Related Costs: We exclude the impact
of certain amounts recorded in connection with business combinations and
divestitures from our adjusted financial results that are either
non-cash or not normal, recurring operating expenses due to their
nature, variability of amounts, and lack of predictability as to
occurrence and/or timing. These amounts may include non-cash items such
as the amortization of acquired intangible assets, amortization of
purchase accounting adjustments to inventories, intangible asset
impairment charges and expense or income related to changes in the
estimated fair value measurement of contingent consideration. We also
exclude transaction and certain other cash costs associated with
business acquisitions and divestitures that are not normal recurring
operating expenses, including severance costs which are not part of a
formal restructuring program.
Share-based Compensation Expense: We exclude share-based
compensation from our adjusted financial results because share-based
compensation expense, which is non-cash, fluctuates from period to
period based on factors that are not within our control, such as our
stock price on the dates share-based grants are issued.
Collaboration-related Upfront Expenses: We exclude
collaboration-related upfront expenses from our adjusted financial
results because we do not consider them to be normal, recurring
operating expenses due to their nature, variability of amounts, and lack
of predictability as to occurrence and/or timing. Upfront payments to
collaboration partners are made at the commencement of a relationship
anticipated to continue for a multi-year period and provide us with
intellectual property rights, option rights and other rights with
respect to particular programs. The variability of amounts and lack of
predictability of collaboration-related upfront expenses makes the
identification of trends in our ongoing research and development
activities more difficult. We believe the presentation of adjusted
research and development, which does not include collaboration-related
upfront expenses, provides useful and meaningful information about our
ongoing research and development activities by enhancing investors'
understanding of our normal, recurring operating research and
development expenses and facilitates comparisons between periods and
with respect to projected performance. All expenses incurred subsequent
to the initiation of the collaboration arrangement, such as research and
development cost-sharing expenses/reimbursements and milestone payments
up to the point of regulatory approval are considered to be normal,
recurring operating expenses and are included in our adjusted financial
results.
Research and Development Asset Acquisition Expense: We exclude
costs associated with acquiring rights to pre-commercial compounds
because we do not consider such costs to be normal, recurring operating
expenses due to their nature, variability of amounts, and lack of
predictability as to occurrence and/or timing. Research and development
asset acquisition expenses includes expenses to acquire rights to
pre-commercial compounds from a collaboration partner when there will be
no further participation from the collaboration partner or other
parties. The variability of amounts and lack of predictability of
research and development asset acquisition expenses makes the
identification of trends in our ongoing research and development
activities more difficult. We believe the presentation of adjusted
research and development, which does not include research and
development asset acquisition expenses, provides useful and meaningful
information about our ongoing research and development activities by
enhancing investors' understanding of our normal, recurring operating
research and development expenses and facilitates comparisons between
periods and with respect to projected performance.
Restructuring Costs: We exclude costs associated with
restructuring initiatives from our adjusted financial results. These
costs include amounts associated with facilities to be closed, employee
separation costs and costs to move operations from one location to
another. We do not frequently undertake restructuring initiatives and
therefore do not consider such costs to be normal, recurring operating
expenses.
Certain Other Items: We exclude certain other significant items
that may occur occasionally and are not normal, recurring, cash
operating expenses from our adjusted financial results. Such items are
evaluated on an individual basis based on both the quantitative and the
qualitative aspect of their nature and generally represent items that,
either as a result of their nature or magnitude, we would not anticipate
occurring as part of our normal business on a regular basis. While not
all-inclusive, examples of certain other significant items excluded from
adjusted financial results would be: impairment charges for significant
fair value adjustments to equity investments, significant
litigation-related loss contingency accruals and expenses to settle
other disputed matters, and changes in the carrying value of our equity
investments beginning in 2018.
Estimated Tax Impact From Above Adjustments: We exclude the net
income tax impact of the non-tax adjustments described above from our
adjusted financial results. The net income tax impact of the non-tax
adjustments includes the impact on both current and deferred income
taxes and is based on the taxability of the adjustment under local tax
law and the statutory tax rate in the tax jurisdiction where the
adjustment was incurred.
Non-Operating Tax Adjustments: We exclude the net income tax
impact of certain other significant income tax items, which are not
associated with our normal, recurring operations ("Non-Operating Tax
Items"), from our adjusted financial results. Non-Operating Tax Items
include items which may occur occasionally and are not normal, recurring
operating expenses (or benefits), including adjustments related to
acquisitions, divestitures, collaborations, certain adjustments to
the amount of unrecognized tax benefits related to prior year tax
positions, the impact of tax reform legislation commonly referred to as
the Tax Cuts and Jobs Act, the impact resulting from intra-entity
transfers of assets other than inventory beginning in 2018, and other
similar items. We also exclude excess tax benefits and tax deficiencies
that arise upon vesting or exercise of share-based payments recognized
as income tax benefits or expenses due to their nature, variability of
amounts, and lack of predictability as to occurrence and/or timing.
Long-Term Targets
A reconciliation of long-term adjusted financial targets to the most
comparable GAAP measures cannot be provided because we are unable to
forecast with reasonable certainty many of the items necessary to
calculate such comparable GAAP measures, including share-based
compensation expense, collaboration-related upfront expense, research
and development asset acquisition expense, acquisition-related expenses,
fair value adjustments to contingent consideration, the ultimate outcome
of legal proceedings and unusual gains and losses, as well as unforeseen
events, risks and developments. These items are uncertain, depend on
various factors, and could be material to our results computed in
accordance with GAAP. We believe the inherent uncertainties in
reconciling our long-term non-GAAP measures to the most comparable GAAP
measures would make the forecasted comparable GAAP measures nearly
impossible to predict with reasonable certainty and therefore inherently
unreliable.
See the attached Reconciliations of GAAP to Adjusted Net Income for
explanations of the amounts excluded and included to arrive at the
adjusted measures for the three- and twelve-month periods ended December
31, 2017 and 2016, and for the projected amounts for the twelve-month
period ending December 31, 2018.
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Celgene Corporation and Subsidiaries
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Condensed Consolidated Statements of Operations
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(Unaudited)
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(In millions, except per share data)
|
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|
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Three-Month Periods Ended
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Twelve-Month Periods Ended
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December 31,
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December 31,
|
|
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2017
|
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2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
3,479
|
|
|
$
|
2,977
|
|
|
$
|
12,973
|
|
|
$
|
11,185
|
|
Other revenue
|
|
|
4
|
|
|
|
3
|
|
|
|
30
|
|
|
|
44
|
|
Total revenue
|
|
|
3,483
|
|
|
|
2,980
|
|
|
|
13,003
|
|
|
|
11,229
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets)
|
|
|
119
|
|
|
|
113
|
|
|
|
461
|
|
|
|
438
|
|
Research and development
|
|
|
2,738
|
|
|
|
1,135
|
|
|
|
5,915
|
|
|
|
4,470
|
|
Selling, general and administrative
|
|
|
774
|
|
|
|
685
|
|
|
|
2,941
|
|
|
|
2,658
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|
Amortization of acquired intangible assets
|
|
|
79
|
|
|
|
105
|
|
|
|
329
|
|
|
|
459
|
|
Acquisition related (gains) charges and restructuring, net
|
|
|
(1,425
|
)
|
|
|
13
|
|
|
|
(1,350
|
)
|
|
|
38
|
|
Total costs and expenses
|
|
|
2,285
|
|
|
|
2,051
|
|
|
|
8,296
|
|
|
|
8,063
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
1,198
|
|
|
|
929
|
|
|
|
4,707
|
|
|
|
3,166
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income, net
|
|
|
33
|
|
|
|
9
|
|
|
|
105
|
|
|
|
30
|
|
Interest (expense)
|
|
|
(142
|
)
|
|
|
(127
|
)
|
|
|
(522
|
)
|
|
|
(500
|
)
|
Other income (expense), net
|
|
|
42
|
|
|
|
(312
|
)
|
|
|
24
|
|
|
|
(324
|
)
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
1,131
|
|
|
|
499
|
|
|
|
4,314
|
|
|
|
2,372
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
|
1,212
|
|
|
|
70
|
|
|
|
1,374
|
|
|
|
373
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(81
|
)
|
|
$
|
429
|
|
|
$
|
2,940
|
|
|
$
|
1,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.10
|
)
|
|
$
|
0.55
|
|
|
$
|
3.77
|
|
|
$
|
2.57
|
|
Diluted
|
|
$
|
(0.10
|
)
|
|
$
|
0.53
|
|
|
$
|
3.64
|
|
|
$
|
2.49
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
773.5
|
|
|
|
776.8
|
|
|
|
779.2
|
|
|
|
777.2
|
|
Diluted
|
|
|
773.5
|
|
|
|
802.2
|
|
|
|
808.7
|
|
|
|
803.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
Balance sheet items:
|
|
|
|
|
|
|
|
|
Cash, cash equivalents & marketable securities
|
|
$
|
12,042
|
|
|
$
|
7,970
|
|
|
|
|
|
Total assets
|
|
|
30,141
|
|
|
|
28,086
|
|
|
|
|
|
Long-term debt, including current portion
|
|
|
15,838
|
|
|
|
14,290
|
|
|
|
|
|
Total stockholders' equity
|
|
|
6,921
|
|
|
|
6,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Reconciliation of GAAP to Adjusted Net Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended
|
|
Twelve-Month Periods Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income - GAAP
|
|
|
$
|
(81
|
)
|
|
$
|
429
|
|
|
$
|
2,940
|
|
|
$
|
1,999
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1)
|
|
7
|
|
|
|
8
|
|
|
|
29
|
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1)
|
|
68
|
|
|
|
64
|
|
|
|
268
|
|
|
|
253
|
|
Collaboration-related upfront expense
|
|
(2)
|
|
96
|
|
|
|
128
|
|
|
|
765
|
|
|
|
816
|
|
Research and development asset acquisition expense
|
|
(3)
|
|
-
|
|
|
|
270
|
|
|
|
325
|
|
|
|
893
|
|
IPR&D asset impairment charge
|
|
(4)
|
|
1,620
|
|
|
|
-
|
|
|
|
1,620
|
|
|
|
-
|
|
Clinical trial & development activity wind-down charge
|
|
(4)
|
|
188
|
|
|
|
-
|
|
|
|
188
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1)
|
|
87
|
|
|
|
83
|
|
|
|
347
|
|
|
|
320
|
|
Litigation-related loss contingency accrual expense
|
|
(5)
|
|
-
|
|
|
|
69
|
|
|
|
315
|
|
|
|
199
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
(6)
|
|
79
|
|
|
|
105
|
|
|
|
329
|
|
|
|
459
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related (gains) charges and restructuring, net:
|
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
(7)
|
|
(1,425
|
)
|
|
|
9
|
|
|
|
(1,350
|
)
|
|
|
22
|
|
Restructuring charges
|
|
(8)
|
|
-
|
|
|
|
3
|
|
|
|
-
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
|
Impairment of equity investment
|
|
(9)
|
|
-
|
|
|
|
272
|
|
|
|
-
|
|
|
|
272
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision:
|
|
|
|
|
|
|
|
|
|
Estimated tax impact from above adjustments
|
|
(10)
|
|
(299
|
)
|
|
|
(74
|
)
|
|
|
(686
|
)
|
|
|
(432
|
)
|
Non-operating tax adjustments
|
|
(11)
|
|
1,252
|
|
|
|
(76
|
)
|
|
|
926
|
|
|
|
(80
|
)
|
Net income - Adjusted
|
|
|
$
|
1,592
|
|
|
$
|
1,290
|
|
|
$
|
6,016
|
|
|
$
|
4,770
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - Adjusted
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
2.06
|
|
|
$
|
1.66
|
|
|
$
|
7.72
|
|
|
$
|
6.14
|
|
Diluted
|
|
(12)
|
$
|
2.00
|
|
|
$
|
1.61
|
|
|
$
|
7.44
|
|
|
$
|
5.94
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Explanation of adjustments:
|
(1)
|
|
Exclude share-based compensation expense totaling $162 for the
three-month period ended December 31, 2017 and $155 for the
three-month period ended December 31, 2016.
|
|
|
Exclude share-based compensation expense totaling $644 for the
twelve-month period ended December 31, 2017 and $606 for the
twelve-month period ended December 31, 2016.
|
(2)
|
|
Exclude upfront payment expense for research and development
collaboration arrangements.
|
(3)
|
|
Exclude research and development asset acquisition expenses.
|
(4)
|
|
Exclude charges associated with the discontinuance of GED-0301
clinical trials in Crohn's disease (Trials), including impairment of
an IPR&D asset and other one-time charges
|
|
|
related to wind-down costs associated with discontinuing the Trials
and certain development activities.
|
(5)
|
|
Exclude loss contingency accrual expenses related to a civil
litigation matter in 2017 and contractual dispute in 2016.
|
(6)
|
|
Exclude amortization of intangible assets acquired in the
acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc.
(Gloucester), Abraxis BioScience, Inc. (Abraxis), Celgene
|
|
|
Avilomics Research, Inc. (Avila) and Quanticel Pharmaceuticals, Inc.
(Quanticel).
|
(7)
|
|
Exclude changes in the fair value of contingent consideration
related to the acquisitions of Gloucester, Abraxis, Avila, Nogra
Pharma Limited (Nogra) and Quanticel, including the
|
|
|
impact to the Nogra contingent consideration liabilities related to
the discontinuance of the Trials.
|
(8)
|
|
Exclude restructuring charges related to our relocation of certain
operations into our two Summit, NJ locations as well as costs
associated with certain headcount reductions.
|
(9)
|
|
Fair value adjustment to our equity investment in Juno Therapeutics,
Inc. (Juno) per ASC 320 "Investments - Debt and Equity Securities."
|
(10)
|
|
Exclude the estimated tax impact of the above adjustments.
|
(11)
|
|
Exclude other non-operating tax expense items. The adjustments for
the three-month period ended December 31, 2017 are to exclude
expense of $1,269 as a result of the
|
|
|
implementation of tax reform legislation (2017 Tax Act) and excess
tax benefits related to the adoption of ASU 2016-09
(Compensation-Stock Compensation) of $17. The
|
|
|
adjustments for the twelve-month period ended December 31, 2017 are
to exclude expense of $1,269 as a result of the implementation of
the 2017 Tax Act, excess tax benefits related
|
|
|
to the adoption of ASU 2016-09 (Compensation-Stock Compensation) of
$290, prior year tax benefits arising from a U.S. research and
development and orphan drug tax credits study
|
|
|
of $55 and to exclude other adjustments totaling tax expense of $2.
The adjustments for the three- and twelve-month periods ended
December 31, 2016 are to exclude the tax benefit
|
|
|
of a tax loss incurred on our investment in Avila of $80 in both
periods, with the three-month period also including other
adjustments totaling tax expense of $4.
|
(12)
|
|
Diluted net income per share for the three-month period ended
December 31, 2017 was determined using diluted weighted-average
shares of 797.4 million.
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Reconciliation of Full-Year 2018 Projected GAAP to Adjusted Net
Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Range
|
|
|
|
|
Low
|
|
High
|
|
|
|
|
|
|
|
Projected net income - GAAP
|
|
(1)
|
|
$
|
5,629
|
|
|
$
|
5,934
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
30
|
|
|
|
27
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
268
|
|
|
|
247
|
|
Research and development asset acquisition expense
|
|
|
|
|
1,115
|
|
|
|
1,115
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
348
|
|
|
|
321
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
|
|
|
260
|
|
|
|
235
|
|
|
|
|
|
|
|
|
Acquisition related (gains) charges and restructuring, net:
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
|
|
|
3
|
|
|
|
3
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
Changes in fair value of equity investments
|
|
|
|
|
(780
|
)
|
|
|
(780
|
)
|
|
|
|
|
|
|
|
Income tax provision:
|
|
|
|
|
|
|
Estimated tax impact from above adjustments
|
|
|
|
|
(130
|
)
|
|
|
(204
|
)
|
Non-operating tax adjustments
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
Projected net income - Adjusted
|
|
|
|
$
|
6,743
|
|
|
$
|
6,898
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - GAAP
|
|
|
|
$
|
7.26
|
|
|
$
|
7.66
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - Adjusted
|
|
|
|
$
|
8.70
|
|
|
$
|
8.90
|
|
|
|
|
|
|
|
|
Projected weighted average diluted shares
|
|
|
|
|
775.0
|
|
|
|
775.0
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Our projected 2018 earnings do not include the effect of any
business combinations (including the effect of our recently
announced pending acquisition of Juno), collaboration agreements,
asset acquisitions, asset impairments, additional litigation-related
loss contingency accruals, changes in the fair value of our CVRs
issued as part of the acquisition of Abraxis, changes in the fair
value of equity investments due to the adoption of ASU 2016-01
(Financial Instruments-Overall: Recognition and Measurement of
Financial Assets and Financial Liabilities) or non-operating tax
adjustments that may occur after the day prior to the date of this
press release.
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Net Product Sales
|
(In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods
|
|
|
Ended December 31,
|
|
% Change
|
|
|
2017
|
|
2016
|
|
Reported
|
|
Operational(1)
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
1,473
|
|
$
|
1,187
|
|
24.1
|
%
|
|
24.1
|
%
|
|
0.0
|
%
|
International
|
|
|
715
|
|
|
621
|
|
15.1
|
%
|
|
18.7
|
%
|
|
(3.6
|
)%
|
Worldwide
|
|
|
2,188
|
|
|
1,808
|
|
21.0
|
%
|
|
22.2
|
%
|
|
(1.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
283
|
|
|
219
|
|
29.2
|
%
|
|
29.2
|
%
|
|
0.0
|
%
|
International
|
|
|
159
|
|
|
159
|
|
0.0
|
%
|
|
3.9
|
%
|
|
(3.9
|
)%
|
Worldwide
|
|
|
442
|
|
|
378
|
|
16.9
|
%
|
|
18.5
|
%
|
|
(1.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
303
|
|
|
268
|
|
13.1
|
%
|
|
13.1
|
%
|
|
0.0
|
%
|
International
|
|
|
68
|
|
|
37
|
|
83.8
|
%
|
|
85.4
|
%
|
|
(1.6
|
)%
|
Worldwide
|
|
|
371
|
|
|
305
|
|
21.6
|
%
|
|
21.8
|
%
|
|
(0.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
155
|
|
|
172
|
|
(9.9
|
)%
|
|
(9.9
|
)%
|
|
0.0
|
%
|
International
|
|
|
96
|
|
|
94
|
|
2.1
|
%
|
|
7.2
|
%
|
|
(5.1
|
)%
|
Worldwide
|
|
|
251
|
|
|
266
|
|
(5.6
|
)%
|
|
(3.8
|
)%
|
|
(1.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
IDHIFA® (3)
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
13
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
International
|
|
|
-
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
13
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
3
|
|
|
2
|
|
50.0
|
%
|
|
50.0
|
%
|
|
0.0
|
%
|
International
|
|
|
160
|
|
|
151
|
|
6.0
|
%
|
|
10.3
|
%
|
|
(4.3
|
)%
|
Worldwide
|
|
|
163
|
|
|
153
|
|
6.5
|
%
|
|
10.7
|
%
|
|
(4.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
4
|
|
|
10
|
|
(60.0
|
)%
|
|
(60.0
|
)%
|
|
0.0
|
%
|
International
|
|
|
-
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
4
|
|
|
10
|
|
(60.0
|
)%
|
|
(60.0
|
)%
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
16
|
|
|
22
|
|
(27.3
|
)%
|
|
(27.3
|
)%
|
|
0.0
|
%
|
International
|
|
|
12
|
|
|
13
|
|
(7.7
|
)%
|
|
(4.4
|
)%
|
|
(3.3
|
)%
|
Worldwide
|
|
|
28
|
|
|
35
|
|
(20.0
|
)%
|
|
(18.7
|
)%
|
|
(1.3
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
16
|
|
|
19
|
|
(15.8
|
)%
|
|
(15.8
|
)%
|
|
0.0
|
%
|
International
|
|
|
2
|
|
|
2
|
|
0.0
|
%
|
|
(1.9
|
)%
|
|
1.9
|
%
|
Worldwide
|
|
|
18
|
|
|
21
|
|
(14.3
|
)%
|
|
(14.5
|
)%
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
-
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
International
|
|
|
1
|
|
|
1
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
1
|
|
|
1
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
2,266
|
|
|
1,899
|
|
19.3
|
%
|
|
19.3
|
%
|
|
0.0
|
%
|
International
|
|
|
1,213
|
|
|
1,078
|
|
12.5
|
%
|
|
16.3
|
%
|
|
(3.8
|
)%
|
Worldwide
|
|
$
|
3,479
|
|
$
|
2,977
|
|
16.9
|
%
|
|
18.3
|
%
|
|
(1.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Operational includes impact from both volume and price
|
(2)
|
|
Currency includes the impact from both foreign exchange rates and
hedging activities
|
(3)
|
|
IDHIFA® was approved in August 2017 in the U.S. for the
treatment of adult patients with R/R AML with an isocitrate
dehydrogenase-2 (IDH2) mutation as detected by an FDA approved
test.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Net Product Sales
|
(In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve-Month Periods
|
|
|
Ended December 31,
|
|
% Change
|
|
|
2017
|
|
2016
|
|
Reported
|
|
Operational(1)
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
5,426
|
|
$
|
4,417
|
|
22.8
|
%
|
|
22.8
|
%
|
|
0.0
|
%
|
International
|
|
|
2,761
|
|
|
2,557
|
|
8.0
|
%
|
|
10.2
|
%
|
|
(2.2
|
)%
|
Worldwide
|
|
|
8,187
|
|
|
6,974
|
|
17.4
|
%
|
|
18.2
|
%
|
|
(0.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1,008
|
|
|
778
|
|
29.6
|
%
|
|
29.6
|
%
|
|
0.0
|
%
|
International
|
|
|
606
|
|
|
533
|
|
13.7
|
%
|
|
16.9
|
%
|
|
(3.2
|
)%
|
Worldwide
|
|
|
1,614
|
|
|
1,311
|
|
23.1
|
%
|
|
24.4
|
%
|
|
(1.3
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1,058
|
|
|
904
|
|
17.0
|
%
|
|
17.0
|
%
|
|
0.0
|
%
|
International
|
|
|
221
|
|
|
113
|
|
95.6
|
%
|
|
94.3
|
%
|
|
1.3
|
%
|
Worldwide
|
|
|
1,279
|
|
|
1,017
|
|
25.8
|
%
|
|
25.7
|
%
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
607
|
|
|
634
|
|
(4.3
|
)%
|
|
(4.3
|
)%
|
|
0.0
|
%
|
International
|
|
|
385
|
|
|
339
|
|
13.6
|
%
|
|
17.5
|
%
|
|
(3.9
|
)%
|
Worldwide
|
|
|
992
|
|
|
973
|
|
2.0
|
%
|
|
3.4
|
%
|
|
(1.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
IDHIFA® (3)
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
20
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
International
|
|
|
-
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
20
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
8
|
|
|
12
|
|
(33.3
|
)%
|
|
(33.3
|
)%
|
|
0.0
|
%
|
International
|
|
|
620
|
|
|
596
|
|
4.0
|
%
|
|
6.6
|
%
|
|
(2.6
|
)%
|
Worldwide
|
|
|
628
|
|
|
608
|
|
3.3
|
%
|
|
5.9
|
%
|
|
(2.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
35
|
|
|
66
|
|
(47.0
|
)%
|
|
(47.0
|
)%
|
|
0.0
|
%
|
International
|
|
|
1
|
|
|
-
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
36
|
|
|
66
|
|
(45.5
|
)%
|
|
(45.5
|
)%
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
80
|
|
|
97
|
|
(17.5
|
)%
|
|
(17.5
|
)%
|
|
0.0
|
%
|
International
|
|
|
52
|
|
|
55
|
|
(5.5
|
)%
|
|
(2.7
|
)%
|
|
(2.8
|
)%
|
Worldwide
|
|
|
132
|
|
|
152
|
|
(13.2
|
)%
|
|
(12.2
|
)%
|
|
(1.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
67
|
|
|
72
|
|
(6.9
|
)%
|
|
(6.9
|
)%
|
|
0.0
|
%
|
International
|
|
|
9
|
|
|
8
|
|
12.5
|
%
|
|
10.3
|
%
|
|
2.2
|
%
|
Worldwide
|
|
|
76
|
|
|
80
|
|
(5.0
|
)%
|
|
(5.2
|
)%
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1
|
|
|
1
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
International
|
|
|
8
|
|
|
3
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
Worldwide
|
|
|
9
|
|
|
4
|
|
N/A
|
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
8,310
|
|
|
6,981
|
|
19.0
|
%
|
|
19.0
|
%
|
|
0.0
|
%
|
International
|
|
|
4,663
|
|
|
4,204
|
|
10.9
|
%
|
|
13.2
|
%
|
|
(2.3
|
)%
|
Worldwide
|
|
$
|
12,973
|
|
$
|
11,185
|
|
16.0
|
%
|
|
16.9
|
%
|
|
(0.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Operational includes impact from both volume and price
|
(2)
|
|
Currency includes the impact from both foreign exchange rates and
hedging activities
|
(3)
|
|
IDHIFA® was approved in August 2017 in the U.S. for the
treatment of adult patients with R/R AML with an isocitrate
dehydrogenase-2 (IDH2) mutation as detected by an FDA approved
test.
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20180125005562/en/
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|