[October 26, 2017] |
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Celgene Reports Third Quarter 2017 Operating and Financial Results
Celgene Corporation (NASDAQ:CELG) reported net product sales of $3,283
million for the third quarter of 2017, an 11 percent increase from the
same period in 2016. Celgene reported third quarter of 2017 total
revenue of $3,287 million, a 10 percent increase compared to $2,983
million in the third quarter of 2016.
Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene
reported net income of $988 million and diluted earnings per share (EPS)
of $1.21 for the third quarter of 2017. For the third quarter of 2016,
GAAP net income was $171 million and diluted EPS was $0.21.
Adjusted net income for the third quarter of 2017 increased 23 percent
to $1,555 million compared to $1,264 million in the third quarter of
2016. For the same period, adjusted diluted EPS increased 21 percent to
$1.91 from $1.58.
"In consideration of certain market dynamics and recent pipeline events,
we are updating our 2020 outlook, and remain confident in our ability to
deliver industry leading growth," said Mark J. Alles, Chief Executive
Officer of Celgene Corporation. "Over the coming months, we look forward
to sharing data supporting our innovative, next generation pipeline
products and significant growth drivers."
Third Quarter 2017 Financial Highlights
Unless otherwise stated, all comparisons are for the third quarter of
2017 compared to the third quarter of 2016. The adjusted operating
expense categories presented below exclude share-based employee
compensation expense, research and development asset acquisition
expense, collaboration-related upfront expense and 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 third quarter increased 10 percent
to $2,081 million. Sales growth was driven primarily by increased
volume, as a result of increases in duration and market share. U.S.
sales of $1,361 million and international sales of $720 million
increased 18 percent and decreased 2 percent year-over-year,
respectively.
-
POMALYST®/IMNOVID® sales for the third quarter
were $417 million, an increase of 22 percent year-over-year. U.S.
sales were $268 million and international sales were $149 million, an
increase of 32 percent and 8 percent year-over-year, respectively.
POMALYST®/IMNOVID® sales growth was driven
primarily by increased volume as a result of increases in market share
and duration.
-
OTEZLA® sales for the third quarter were $308 million, a 12
percent increase year-over-year. Third quarter U.S. sales of $250
million and international sales of $58 million increased 2 percent and
87 percent, respectively. OTEZLA® sales in the U.S. were
impacted by an increase in gross-to-net adjustments from contracts
implemented in January and a slowing in overall category growth due to
a more challenging market access environment.
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ABRAXANE® sales for the third quarter were $251 million, an
8 percent increase year-over-year. U.S. sales were $149 million and
international sales were $102 million, an increase of 3 percent and 15
percent, respectively. ABRAXANE® market shares in the U.S.
for pancreatic cancer, first-line advanced non-squamous lung cancer
and metastatic breast cancer remain stable. Growth in Europe was
driven by market share gains for ABRAXANE® in pancreatic
cancer.
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In the third 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 $226 million compared to $228 million
in the third quarter of 2016.
-
Total net product sales for the third quarter of 2017 increased 11
percent year-over-year, driven by operational growth. Net product
sales growth also includes a 1.0 percent negative impact from currency
exchange effects.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $1,347 million for the third quarter
of 2017 versus $1,653 million for the same period in 2016. The third
quarter decrease was due to a reduction in research and development
asset acquisition expenses partially offset by an increase in
collaboration-related upfront expense.
Adjusted R&D expenses were $698 million for the third quarter of 2017
compared to $643 million for the third quarter of 2016. The third
quarter increase was due to increased spending related to drug discovery
and clinical trial activity.
Selling, General, and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $608 million for the third quarter
of 2017 compared to $698 million for the same period in 2016.
Adjusted SG&A expenses were $521 million for the third quarter of 2017
compared to $591 million for the third quarter of 2016.
Cash, Cash Equivalents, and Marketable Securities
Operating cash flow was $1.1 billion in the third quarter of 2017,
compared to $770 million for the third quarter of 2016. In the third
quarter, Celgene purchased approximately 0.9 million of its shares at a
total cost of approximately $114 million. As of September 30, 2017, the
Company had approximately $3.8 billion remaining under its stock
repurchase program. Celgene ended the quarter with approximately $11.8
billion in cash, cash equivalents and marketable securities.
2017 Guidance Updated
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Previous 2017 Guidance
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Updated 2017 Guidance
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Net Product Sales
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REVLIMID(®)
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$8.0B to $8.3B
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Unchanged
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POMALYST(®)/IMNOVID(®)
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Approximately $1.6B
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Unchanged
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OTEZLA(® )
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$1.5B to $1.7B
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Approximately $1.25B
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ABRAXANE(®)
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Approximately $1.0B
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Unchanged
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Total Revenue
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$13.0B to $13.4B
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Approximately $13.0B
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GAAP operating margin
GAAP diluted EPS
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Approximately 41.5%
$5.36 to $5.62
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Approximately 37.5%
$4.78 to $5.19
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Adjusted operating margin
Adjusted diluted EPS
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Approximately 57.5%
$7.25 to $7.35
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Approximately 58.5%
$7.30 to $7.35
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Weighted average diluted shares
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Approximately 815M
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Unchanged
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2020 Long-Term Financial Targets Updated
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Original 2020 Targets (Issued 1/12/15)*
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Updated 2020 Targets (Low-end)
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Updated 2020 Targets (High-end)
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Hematology
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Existing products/Indications
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$13.0B
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$14.7B
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$14.7B
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New products/ Indications
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$1.8B
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$0.7B
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$1.4B
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Total Hematology
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>$14.8B
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$15.4B
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$16.1B
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Total Oncology
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>$2.2B
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$1.0B
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$1.1B
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Total I&I
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> $4.0B
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$2.6B
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$2.8B
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Total Net Product Sales
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>$21.0B
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$19.0B
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$20.0B
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Adjusted Diluted EPS
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>$13.00
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? $12.50
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*Updated upon acquisition of Receptos in July 2015
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Product and Pipeline Updates
Hematology & Oncology
-
In August, the U.S. Food and Drug Administration (FDA) approved the
use of IDHIFA® (enasidenib) for the treatment of adult
patients with relapsed or refractory acute myeloid leukemia (AML) with
an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA
approved test.
-
In September, Celgene submitted an Investigational New Drug (IND)
application to the FDA for CC-92480, a next-generation CELMoD®
compound in patients with multiple myeloma.
-
In September, Celgene and partner AstraZeneca announced that the FDA
placed a partial clinical hold on five trials and a full clinical hold
on one trial in the FUSION™ clinical program evaluating
IMFINZI™ (durvalumab) in combination with immunomodulatory
and chemotherapy agents in hematological malignancies. The decision by
the FDA was based on risks identified in other trials evaluating
pembrolizumab in combination with immunomodulatory agents in patients
with multiple myeloma. The two trials evaluating IMFINZI™
in patients with myelodysplastic syndromes (MDS) and AML are
continuing as planned.
-
Celgene is advancing a robust campaign targeting B-cell maturation
antigen (BCMA) across several modalities in patients with multiple
myeloma. In collaboration with partner bluebird bio, the lead program
evaluating bb2121, an anti-BCMA chimeric antigen receptor (CAR)-T cell
therapy in relapsed and/or refractory multiple myeloma (RRMM) is
advancing and a pivotal trial is expected to begin by year-end. In
September, Celgene and bluebird bio announced the initiation of a
phase I trial evaluating bb21217, a second anti- BCMA CAR-T program in
patients with RRMM.
-
Celgene and collaboration partner Juno Therapeutics initiated the
TRANSCEND pivotal program in the U.S. evaluating investigational
anti-CD19 CAR-T cell product candidate JCAR017 in patients with
diffuse large B-cell lymphoma (DLBCL).
At the 2017 American Society of Hematology (ASH) annual meeting in
December, data presentations expected include:
-
Data from studies evaluating the gene expression signature of CELMoD®
compound CC-122 in patients with DLBCL.
-
Updated data from the phase Ib trial evaluating CC-122 in combination
with obinutuzumab in patients with DLBCL, follicular lymphoma (FL) or
marginal zone lymphoma (MZL).
-
Updated data from the phase I trial evaluating CC-486 in combination
with rituximab plus chemotherapy (R-CHOP) in patients with DLBCL, FL
or transformed lymphoma.
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Celgene and Agios Pharmaceuticals are expected to present 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 IDH2
mutation.
-
Celgene and bluebird bio are expected to present updated data from the
phase I trial evaluating bb2121 in patients with RRMM.
-
Celgene's collaboration partner Juno Therapeutics is expected to
present updated data from the phase I TRANSCEND trial evaluating
JCAR017 in patients with relapsed or refractory non-Hodgkin lymphoma
(NHL).
Inflammation & Immunology
-
The phase III RELIEF® (n= 207) trial evaluating OTEZLA®
in patients with active Behçet's disease achieved the primary endpoint
of Area Under the Curve (AUC) for the number of oral ulcers from
baseline through week 12. The safety profile for OTEZLA® in
the RELIEF® trial is generally consistent with the overall
safety profile of OTEZLA®. The full data-set will be
presented at a future medical meeting. These data form the basis of
global regulatory applications that are planned beginning in 2018.
-
The phase IIb trial evaluating CELMoD® compound CC-220 in
patients with systemic lupus erythematosus (SLE) initiated in the
third quarter.
Data at inflammation and immunology medical congresses presented in the
third quarter and expected in the fourth quarter include:
-
Data from the phase III SUNBEAM™ and RADIANCE™
trials evaluating ozanimod in patients with relapsing multiple
sclerosis (RMS) will be 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 New
Drug Application (NDA) to the FDA for ozanimod in RMS by year-end.
-
In October, data from the phase II STEPSTONE™ trial
evaluating ozanimod in patients with moderately to severely active
Crohn's disease were presented at the World Congress of
Gastroenterology (WCOG) at ACG2017 meeting. In the STEPSTONE™
trial, ozanimod demonstrated meaningful clinical and endoscopic
improvements in patients with moderately to severely active Crohn's
disease at week 12. In addition, data from the phase II STEPSTONE™
trial will be presented at the United European Gastroenterology Week
(UEGW) in October. Based on these data, Celgene plans to initiate a
phase III pivotal trial with ozanimod in Crohn's disease in the next
few months.
-
Data from the phase Ib trial evaluating CC-90001, a second-generation
Jun N-Terminal Kinase (JNK) inhibitor, in patients with idiopathic
pulmonary fibrosis (IPF) were presented at the 2017 European
Respiratory Society (ERS) annual congress in September. The phase IIa
trial evaluating CC-90001 in IPF initiated in the third quarter.
-
In October, Celgene announced the discontinuation of the phase III
REVOLVE trial (CD-002) and the long-term extension trial (SUSTAIN,
CD-004) evaluating GED-0301 in Crohn's disease, based on the
recommendation of the Data Monitoring Committee (DMC) which assessed
overall benefit/risk during a recent interim futility analysis. There
were no meaningful safety imbalances identified in the analysis. In
addition, the phase III DEFINE trial with GED-0301 in CD will not be
initiated and Celgene is waiting to review the full dataset from the
phase II trial with GED-0301 in ulcerative colitis (UC) to determine
next steps.
-
The phase III TRUE NORTH™ trial evaluating ozanimod in
ulcerative colitis is ongoing and expected to complete enrollment in
the second half of 2018.
Third Quarter 2017 Conference Call and Webcast Information
Celgene will host a conference call to discuss the third quarter of 2017
operational and financial performance on Thursday, October 26, 2017, 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 October 26,
2017, until midnight ET November 2, 2017. To access the replay in the
U.S., dial (855) 859-2056; outside the U.S. dial (404) 537-3406. The
participant passcode is 93165037.
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.
About REVLIMID®
In the U.S., REVLIMID® (lenalidomide) in combination with
dexamethasone is indicated for the treatment of patients with multiple
myeloma. REVLIMID® as a single agent is also indicated as a
maintenance therapy in patients with multiple myeloma following
autologous hematopoietic stem cell transplant. REVLIMID® is
indicated for patients with transfusion-dependent anemia due to low- or
intermediate-1-risk myelodysplastic syndromes (MDS) associated with a
deletion 5q cytogenetic abnormality with or without additional
cytogenetic abnormalities. REVLIMID® is approved in the U.S.
for the treatment of patients with mantle cell lymphoma (MCL) whose
disease has relapsed or progressed after two prior therapies, one of
which included bortezomib. Limitations of Use: REVLIMID® is
not indicated and is not recommended for the treatment of chronic
lymphocytic leukemia (CLL) outside of controlled clinical trials.
About ABRAXANE®
In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound) is
indicated for the treatment of metastatic breast cancer after failure of
combination chemotherapy for metastatic disease or relapse within six
months of adjuvant chemotherapy. Prior therapy should have included an
anthracycline unless clinically contraindicated. ABRAXANE® is
indicated for the first-line treatment of locally advanced or metastatic
non-small cell lung cancer, in combination with carboplatin, in patients
who are not candidates for curative surgery or radiation therapy.
ABRAXANE® is also indicated for the first-line treatment of
metastatic adenocarcinoma of the pancreas in combination with
gemcitabine.
About POMALYST®
In the U.S., POMALYST® (pomalidomide) is indicated for
patients with multiple myeloma who have received at least two prior
therapies including lenalidomide and a proteasome inhibitor and have
demonstrated disease progression on or within 60 days of completion of
the last therapy.
About OTEZLA®
In the U.S., OTEZLA® (apremilast) is indicated for the
treatment of adult patients with active psoriatic arthritis. OTEZLA®
is indicated in the U.S. for the treatment of patients with moderate to
severe plaque psoriasis who are candidates for phototherapy or systemic
therapy.
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.
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: expenses for significant fair value
adjustments to equity investments, significant litigation-related loss
contingency accruals and expenses to settle other disputed matters.
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, 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 nine-month periods ended September
30, 2017 and 2016, and for the projected amounts for the twelve-month
period ending December 31, 2017.
|
Celgene Corporation and Subsidiaries
|
Condensed Consolidated Statements of Income
|
(Unaudited)
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended
|
|
Nine-Month Periods Ended
|
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
2017*
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
|
|
$
|
3,283
|
|
|
$
|
2,969
|
|
|
$
|
9,494
|
|
|
$
|
8,208
|
|
Other revenue
|
|
|
|
|
|
4
|
|
|
|
14
|
|
|
|
26
|
|
|
|
41
|
|
|
Total revenue
|
|
|
|
|
|
3,287
|
|
|
|
2,983
|
|
|
|
9,520
|
|
|
|
8,249
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets)
|
|
|
118
|
|
|
|
108
|
|
|
|
342
|
|
|
|
325
|
|
Research and development
|
|
|
|
|
|
1,347
|
|
|
|
1,653
|
|
|
|
3,177
|
|
|
|
3,335
|
|
Selling, general and administrative
|
|
|
|
|
|
608
|
|
|
|
698
|
|
|
|
2,167
|
|
|
|
1,973
|
|
Amortization of acquired intangible assets
|
|
|
|
|
|
80
|
|
|
|
87
|
|
|
|
250
|
|
|
|
354
|
|
Acquisition related charges and restructuring, net
|
|
|
|
|
49
|
|
|
|
25
|
|
|
|
75
|
|
|
|
25
|
|
|
Total costs and expenses
|
|
|
|
|
|
2,202
|
|
|
|
2,571
|
|
|
|
6,011
|
|
|
|
6,012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
|
|
|
1,085
|
|
|
|
412
|
|
|
|
3,509
|
|
|
|
2,237
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income, net
|
|
|
|
|
|
33
|
|
|
|
7
|
|
|
|
72
|
|
|
|
21
|
|
Interest (expense)
|
|
|
|
|
|
(127
|
)
|
|
|
(128
|
)
|
|
|
(380
|
)
|
|
|
(373
|
)
|
Other (expense), net
|
|
|
|
|
|
-
|
|
|
|
(35
|
)
|
|
|
(18
|
)
|
|
|
(12
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
|
|
|
991
|
|
|
|
256
|
|
|
|
3,183
|
|
|
|
1,873
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
|
|
|
|
3
|
|
|
|
85
|
|
|
|
162
|
|
|
|
303
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
$
|
988
|
|
|
$
|
171
|
|
|
$
|
3,021
|
|
|
$
|
1,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
$
|
1.26
|
|
|
$
|
0.22
|
|
|
$
|
3.87
|
|
|
$
|
2.02
|
|
|
Diluted
|
|
|
|
|
$
|
1.21
|
|
|
$
|
0.21
|
|
|
$
|
3.72
|
|
|
$
|
1.95
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
|
784.1
|
|
|
|
775.8
|
|
|
|
781.2
|
|
|
|
777.3
|
|
|
Diluted
|
|
|
|
|
|
815.2
|
|
|
|
801.5
|
|
|
|
812.6
|
|
|
|
803.7
|
|
* During the third quarter of 2017, we adopted ASU 2017-12 with an
initial application date of January 1, 2017. Prior to the adoption
of ASU 2017-12, we recognized all changes in the fair value of the
excluded component of a hedge in Other (expense), net in the
Consolidated Statements of Income under a mark-to-market approach.
Pursuant to the provisions of ASU 2017-12, we no longer recognize
the adjustments to the fair value of the excluded component in Other
(expense), net but we instead recognize the initial value of the
excluded component using an amortization approach over the life of
the hedging instrument. When we report our results for the quarterly
periods ended March 31, 2018 and June 30, 2018, we intend to recast
the financial statements for the quarterly periods ended March 31,
2017 and June 30, 2017, respectively, to reflect the adoption of ASU
2017-12. The nine-month period ended September 30, 2017 includes the
following immaterial revisions to previously issued financial
results:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended
|
|
Three-Month Period Ended
|
|
Six-Month Period Ended
|
|
|
|
March 31, 2017
|
|
June 30, 2017
|
|
June 30, 2017
|
|
|
|
As Reported
|
|
As Revised
|
|
As Reported
|
|
As Revised
|
|
As Reported
|
|
As Revised
|
|
Net product sales
|
|
$
|
2,950
|
|
$
|
2,952
|
|
$
|
3,256
|
|
|
$
|
3,259
|
|
|
$
|
6,206
|
|
|
$
|
6,211
|
|
|
Other (expense) income, net
|
|
|
26
|
|
|
13
|
|
|
(76
|
)
|
|
|
(31
|
)
|
|
|
(50
|
)
|
|
|
(18
|
)
|
|
Income tax provision
|
|
|
84
|
|
|
82
|
|
|
69
|
|
|
|
77
|
|
|
|
153
|
|
|
|
159
|
|
|
Net income
|
|
|
941
|
|
|
932
|
|
|
1,061
|
|
|
|
1,101
|
|
|
|
2,002
|
|
|
|
2,033
|
|
|
Diluted net income per common share
|
|
$
|
1.16
|
|
$
|
1.15
|
|
$
|
1.31
|
|
|
$
|
1.36
|
|
|
$
|
2.47
|
|
|
$
|
2.51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
|
|
Balance sheet items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents & marketable securities
|
|
|
|
|
$
|
11,759
|
|
|
$
|
7,970
|
|
|
|
|
|
|
Total assets
|
|
|
|
|
|
|
31,736
|
|
|
|
28,086
|
|
|
|
|
|
|
Long-term debt, including current portion
|
|
|
|
|
|
|
14,274
|
|
|
|
14,290
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
|
|
|
|
9,850
|
|
|
|
6,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Reconciliation of GAAP to Adjusted Net Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended
|
|
Nine-Month Periods Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
2017*
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income - GAAP
|
|
|
$
|
988
|
|
|
$
|
171
|
|
|
$
|
3,021
|
|
|
$
|
1,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
7
|
|
|
|
8
|
|
|
|
22
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
65
|
|
|
|
63
|
|
|
|
200
|
|
|
|
189
|
|
|
Collaboration-related upfront expense
|
|
(2
|
)
|
|
584
|
|
|
|
324
|
|
|
|
669
|
|
|
|
688
|
|
|
Research and development asset acquisition expense
|
|
(3
|
)
|
|
-
|
|
|
|
623
|
|
|
|
325
|
|
|
|
623
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
87
|
|
|
|
77
|
|
|
|
260
|
|
|
|
238
|
|
|
Litigation-related loss contingency accrual expense
|
|
(4
|
)
|
|
-
|
|
|
|
30
|
|
|
|
315
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
(5
|
)
|
|
80
|
|
|
|
87
|
|
|
|
250
|
|
|
|
354
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related (income) charges and restructuring, net:
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
(6
|
)
|
|
49
|
|
|
|
23
|
|
|
|
75
|
|
|
|
12
|
|
|
Restructuring charges
|
|
(7
|
)
|
|
-
|
|
|
|
2
|
|
|
|
-
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision:
|
|
|
|
|
|
|
|
|
|
|
Estimated tax impact from above adjustments
|
|
(8
|
)
|
|
(149
|
)
|
|
|
(151
|
)
|
|
|
(387
|
)
|
|
|
(357
|
)
|
|
Non-operating tax adjustments
|
|
(9
|
)
|
|
(156
|
)
|
|
|
7
|
|
|
|
(326
|
)
|
|
|
(5
|
)
|
Net income - Adjusted
|
|
|
$
|
1,555
|
|
|
$
|
1,264
|
|
|
$
|
4,424
|
|
|
$
|
3,480
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - Adjusted
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
1.98
|
|
|
$
|
1.63
|
|
|
$
|
5.66
|
|
|
$
|
4.48
|
|
|
Diluted
|
|
|
$
|
1.91
|
|
|
$
|
1.58
|
|
|
$
|
5.44
|
|
|
$
|
4.33
|
|
Explanation of adjustments:
|
|
(1)
|
|
Exclude share-based compensation expense totaling $159 for the
three-month period ended September 30, 2017 and $148 for the
three-month period ended September 30, 2016.
|
|
|
Exclude share-based compensation expense totaling $482 for the
nine-month period ended September 30, 2017 and $452 for the
nine-month period ended September 30, 2016.
|
(2)
|
|
Exclude upfront payment expense for research and development
collaboration arrangements.
|
(3)
|
|
Exclude research and development asset acquisition expenses.
|
(4)
|
|
Exclude loss contingency accrual expenses related to a civil
litigation matter in 2017 and a contractual dispute in 2016.
|
(5)
|
|
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).
|
(6)
|
|
Exclude changes in the fair value of contingent consideration
related to the acquisitions of Gloucester, Abraxis, Avila, Nogra
Pharma Limited and Quanticel.
|
(7)
|
|
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.
|
(8)
|
|
Exclude the estimated tax impact of the above adjustments.
|
(9)
|
|
Exclude other non-operating tax expense items. The adjustments for
the three-month period ended September 30, 2017 are to exclude the
excess tax benefits related to the adoption of
|
|
|
ASU 2016-09 (Compensation-Stock Compensation) of $103, 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 nine-month period ended September 30, 2017 are
to exclude the excess tax benefits related to the
|
|
|
adoption of ASU 2016-09 (Compensation-Stock Compensation) of $273,
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 adjustment for the three-month period ended September 30, 2016
is to include net tax benefits of $7. The
|
|
|
adjustments for the nine-month period ended September 30, 2016 are
to exclude the tax benefit on the settlement of a state tax
examination of $2 and to include other adjustments
|
|
|
totaling tax expense of $3.
|
|
|
|
|
|
|
|
* During the third quarter of 2017, we adopted ASU 2017-12 with an
initial application date of January 1, 2017. Prior to the adoption
of ASU 2017-12, we recognized all changes in the fair value of the
excluded component of a hedge in Other (expense), net in the
Consolidated Statements of Income under a mark-to-market approach.
Pursuant to the provisions of ASU 2017-12, we no longer recognize
the adjustments to the fair value of the excluded component in Other
(expense), net but we instead recognize the initial value of the
excluded component using an amortization approach over the life of
the hedging instrument. When we report our results for the quarterly
periods ended March 31, 2018 and June 30, 2018, we intend to recast
the financial statements for the quarterly periods ended March 31,
2017 and June 30, 2017, respectively, to reflect the adoption of ASU
2017-12. The nine-month period ended September 30, 2017 includes the
following immaterial revisions to previously issued financial
results:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Period Ended
|
|
Three-Month Period Ended
|
|
Six-Month Period Ended
|
|
|
March 31, 2017
|
|
June 30, 2017
|
|
June 30, 2017
|
|
|
As Reported
|
|
As Revised
|
|
As Reported
|
|
As Revised
|
|
As Reported
|
|
As Revised
|
Net income - GAAP
|
|
$
|
941
|
|
$
|
932
|
|
$
|
1,061
|
|
|
$
|
1,101
|
|
$
|
2,002
|
|
|
$
|
2,033
|
Net income - Adjusted
|
|
|
1,364
|
|
|
1,355
|
|
|
1,474
|
|
|
|
1,514
|
|
|
2,838
|
|
|
|
2,869
|
Diluted net income per common share - Adjusted
|
|
$
|
1.68
|
|
$
|
1.67
|
|
$
|
1.82
|
|
|
$
|
1.87
|
|
$
|
3.50
|
|
|
$
|
3.54
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Reconciliation of Full-Year 2017 Projected GAAP to Adjusted Net
Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range
|
|
|
|
|
|
|
Low
|
|
High
|
|
|
|
|
|
|
|
|
|
Projected net income - GAAP
|
|
|
|
(1)
|
$ 3,894
|
|
$ 4,233
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
31
|
|
29
|
|
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
276
|
|
260
|
|
Collaboration-related upfront expense
|
|
|
|
|
674
|
|
674
|
|
Research and development asset acquisition expense
|
|
325
|
|
325
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
355
|
|
334
|
|
Litigation-related loss contingency accrual expense
|
|
315
|
|
315
|
|
|
|
|
|
|
|
|
|
|
GED-0301 charge, net
|
|
|
|
|
500
|
|
300
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
|
|
333
|
|
326
|
|
|
|
|
|
|
|
|
|
|
Acquisition related (income) charges and restructuring, net:
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
|
|
80
|
|
65
|
|
|
|
|
|
|
|
|
|
|
Income tax provision:
|
|
|
|
|
|
|
|
|
Estimated tax impact from above adjustments
|
|
|
|
(507)
|
|
(545)
|
|
Non-operating tax adjustments
|
|
|
|
|
(326)
|
|
(326)
|
|
|
|
|
|
|
|
|
|
Projected net income - Adjusted
|
|
|
|
|
$ 5,950
|
|
$ 5,990
|
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - GAAP
|
|
$ 4.78
|
|
$ 5.19
|
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - Adjusted
|
|
$ 7.30
|
|
$ 7.35
|
|
|
|
|
|
|
|
|
|
Projected weighted average diluted shares
|
|
|
|
815.0
|
|
815.0
|
(1)
|
|
Our projected 2017 earnings do not include the effect of any
business combinations, collaboration agreements, asset acquisitions,
asset impairments, litigation-related loss contingency accruals,
changes in the fair value of our CVRs issued as part of the
acquisition of Abraxis 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 September 30,
|
|
% Change
|
|
|
|
|
2017
|
|
|
2016
|
|
|
Reported
|
|
Operational(1)
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
1,361
|
|
|
$
|
1,154
|
|
|
17.9
|
%
|
|
|
17.9
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
720
|
|
|
|
738
|
|
|
(2.4
|
)%
|
|
|
(0.5
|
)%
|
|
|
(1.9
|
)%
|
|
Worldwide
|
|
|
2,081
|
|
|
|
1,892
|
|
|
10.0
|
%
|
|
|
10.7
|
%
|
|
|
(0.7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
268
|
|
|
|
203
|
|
|
32.0
|
%
|
|
|
32.0
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
149
|
|
|
|
138
|
|
|
8.0
|
%
|
|
|
12.1
|
%
|
|
|
(4.1
|
)%
|
|
Worldwide
|
|
|
417
|
|
|
|
341
|
|
|
22.3
|
%
|
|
|
23.9
|
%
|
|
|
(1.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
250
|
|
|
|
244
|
|
|
2.5
|
%
|
|
|
2.5
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
58
|
|
|
|
31
|
|
|
87.1
|
%
|
|
|
90.2
|
%
|
|
|
(3.1
|
)%
|
|
Worldwide
|
|
|
308
|
|
|
|
275
|
|
|
12.0
|
%
|
|
|
12.3
|
%
|
|
|
(0.3
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
149
|
|
|
|
144
|
|
|
3.5
|
%
|
|
|
3.5
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
102
|
|
|
|
89
|
|
|
14.6
|
%
|
|
|
18.6
|
%
|
|
|
(4.0
|
)%
|
|
Worldwide
|
|
|
251
|
|
|
|
233
|
|
|
7.7
|
%
|
|
|
9.2
|
%
|
|
|
(1.5
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IDHIFA® (3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
7
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
International
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
7
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1
|
|
|
|
3
|
|
|
(66.7
|
)%
|
|
|
(66.7
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
150
|
|
|
|
151
|
|
|
(0.7
|
)%
|
|
|
2.4
|
%
|
|
|
(3.1
|
)%
|
|
Worldwide
|
|
|
151
|
|
|
|
154
|
|
|
(1.9
|
)%
|
|
|
1.1
|
%
|
|
|
(3.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
13
|
|
|
|
16
|
|
|
(18.8
|
)%
|
|
|
(18.8
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
1
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
14
|
|
|
|
16
|
|
|
(12.5
|
)%
|
|
|
(12.5
|
)%
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
21
|
|
|
|
24
|
|
|
(12.5
|
)%
|
|
|
(12.5
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
13
|
|
|
|
14
|
|
|
(7.1
|
)%
|
|
|
(4.4
|
)%
|
|
|
(2.7
|
)%
|
|
Worldwide
|
|
|
34
|
|
|
|
38
|
|
|
(10.5
|
)%
|
|
|
(9.5
|
)%
|
|
|
(1.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
17
|
|
|
|
18
|
|
|
(5.6
|
)%
|
|
|
(5.6
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
2
|
|
|
|
2
|
|
|
0.0
|
%
|
|
|
(1.1
|
)%
|
|
|
1.1
|
%
|
|
Worldwide
|
|
|
19
|
|
|
|
20
|
|
|
(5.0
|
)%
|
|
|
(5.1
|
)%
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
International
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
1
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
2,088
|
|
|
|
1,806
|
|
|
15.6
|
%
|
|
|
15.6
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
1,195
|
|
|
|
1,163
|
|
|
2.8
|
%
|
|
|
5.3
|
%
|
|
|
(2.5
|
)%
|
|
Worldwide
|
|
$
|
3,283
|
|
|
$
|
2,969
|
|
|
10.6
|
%
|
|
|
11.6
|
%
|
|
|
(1.0
|
)%
|
(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 mutuation as detected by an FDA approved test.
|
|
|
|
|
Celgene Corporation and Subsidiaries
|
Net Product Sales
|
(In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine-Month Periods
|
|
|
|
Ended September 30,
|
|
% Change
|
|
|
|
2017
|
|
2016
|
|
|
Reported
|
|
Operational(1)
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
3,953
|
|
$
|
3,230
|
|
|
22.4
|
%
|
|
|
22.4
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
2,046
|
|
|
1,936
|
|
|
5.7
|
%
|
|
|
7.5
|
%
|
|
|
(1.8
|
)%
|
|
Worldwide
|
|
|
5,999
|
|
|
5,166
|
|
|
16.1
|
%
|
|
|
16.8
|
%
|
|
|
(0.7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
725
|
|
|
559
|
|
|
29.7
|
%
|
|
|
29.7
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
447
|
|
|
374
|
|
|
19.5
|
%
|
|
|
22.5
|
%
|
|
|
(3.0
|
)%
|
|
Worldwide
|
|
|
1,172
|
|
|
933
|
|
|
25.6
|
%
|
|
|
26.8
|
%
|
|
|
(1.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
755
|
|
|
636
|
|
|
18.7
|
%
|
|
|
18.7
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
153
|
|
|
76
|
|
|
101.3
|
%
|
|
|
98.5
|
%
|
|
|
2.8
|
%
|
|
Worldwide
|
|
|
908
|
|
|
712
|
|
|
27.5
|
%
|
|
|
27.2
|
%
|
|
|
0.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
452
|
|
|
462
|
|
|
(2.2
|
)%
|
|
|
(2.2
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
289
|
|
|
245
|
|
|
18.0
|
%
|
|
|
21.4
|
%
|
|
|
(3.4
|
)%
|
|
Worldwide
|
|
|
741
|
|
|
707
|
|
|
4.8
|
%
|
|
|
6.0
|
%
|
|
|
(1.2
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IDHIFA® (3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
7
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
International
|
|
|
-
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
7
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
5
|
|
|
10
|
|
|
(50.0
|
)%
|
|
|
(50.0
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
460
|
|
|
445
|
|
|
3.4
|
%
|
|
|
5.5
|
%
|
|
|
(2.1
|
)%
|
|
Worldwide
|
|
|
465
|
|
|
455
|
|
|
2.2
|
%
|
|
|
4.2
|
%
|
|
|
(2.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
31
|
|
|
56
|
|
|
(44.6
|
)%
|
|
|
(44.6
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
1
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
32
|
|
|
56
|
|
|
(42.9
|
)%
|
|
|
(42.9
|
)%
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
64
|
|
|
75
|
|
|
(14.7
|
)%
|
|
|
(14.7
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
40
|
|
|
42
|
|
|
(4.8
|
)%
|
|
|
(2.2
|
)%
|
|
|
(2.6
|
)%
|
|
Worldwide
|
|
|
104
|
|
|
117
|
|
|
(11.1
|
)%
|
|
|
(10.2
|
)%
|
|
|
(0.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
51
|
|
|
53
|
|
|
(3.8
|
)%
|
|
|
(3.8
|
)%
|
|
|
0.0
|
%
|
|
International
|
|
|
7
|
|
|
6
|
|
|
16.7
|
%
|
|
|
14.4
|
%
|
|
|
2.3
|
%
|
|
Worldwide
|
|
|
58
|
|
|
59
|
|
|
(1.7
|
)%
|
|
|
(1.9
|
)%
|
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
1
|
|
|
1
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
International
|
|
|
7
|
|
|
2
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
Worldwide
|
|
|
8
|
|
|
3
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
6,044
|
|
|
5,082
|
|
|
18.9
|
%
|
|
|
18.9
|
%
|
|
|
0.0
|
%
|
|
International
|
|
|
3,450
|
|
|
3,126
|
|
|
10.4
|
%
|
|
|
12.2
|
%
|
|
|
(1.8
|
)%
|
|
Worldwide
|
|
$
|
9,494
|
|
$
|
8,208
|
|
|
15.7
|
%
|
|
|
16.4
|
%
|
|
|
(0.7
|
)%
|
(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 mutuation as detected by an FDA approved test.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20171026005748/en/
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