[July 28, 2016] |
|
Celgene Reports Second Quarter 2016 Operating and Financial Results
Celgene Corporation (NASDAQ:CELG) reported net product sales of $2,745
million for the second quarter of 2016, a 22 percent increase from the
same period in 2015. Net product sales growth includes a 1 percent
negative impact from currency exchange effects. Second quarter total
revenue increased 21 percent to $2,754 million compared to $2,278
million in the second quarter of 2015.
Net income for the second quarter of 2016 based on U.S. GAAP (Generally
Accepted Accounting Principles), was $598 million or $0.75 per diluted
share compared to $356 million or $0.43 per diluted share in the second
quarter of 2015. Adjusted net income for the second quarter of 2016 was
$1,152 million or $1.44 per diluted share compared to $1,019 million or
$1.23 per diluted share for the second quarter of 2015.
"Our first-half 2016 operating results were outstanding and we are
pleased with the progress made advancing many key corporate objectives,"
said Mark J. Alles, Chief Executive Officer of Celgene Corporation.
"This strong momentum increases our confidence in our near- and
longer-term outlook as we continue to invest in innovative research and
the development of transformational therapies for patients worldwide."
Second Quarter 2016 Financial Highlights
Unless otherwise stated, all comparisons are for the second quarter of
2016 compared to the second quarter of 2015. The adjusted operating
expense categories presented below exclude share-based employee
compensation expense, upfront collaboration expense and a
litigation-related loss contingency accrual expense. Please see the
attached Reconciliation of GAAP to Adjusted Net Income for further
information.
Net Product Sales Performance
-
REVLIMID® sales for the second quarter increased 18 percent
year-over-year to $1,701 million and were driven by new patient market
share gains and increased duration. U.S. sales of $1,080 million and
international sales of $621 million increased 24 percent and 9 percent
year-over-year, respectively.
-
POMALYST®/IMNOVID® sales for the second quarter
were $318 million, an increase of 35 percent year-over-year. U.S.
sales were $185 million and international sales were $133 million, an
increase of 29 percent and 46 percent year-over-year, respectively.
POMALYST®/IMNOVID® sales grew due to increased
volume from duration gains.
-
ABRAXANE® sales for the second quarter were $249 million, a
2 percent increase year-over-year. U.S. sales of $175 million
increased 3 percent year-over-year. International sales were $74
million.
-
OTEZLA® sales for the second quarter were $242 million, a
170 percent increase year-over-year. U.S. sales were $217 million and
international sales were $25 million. Sales were driven by market
share gains and increased prescriber adoption.
-
In the second quarter, all other product sales, which include THALOMID®,
ISTODAX®, VIDAZA® and an authorized generic
version of VIDAZA® drug product in the U.S., were $235
million compared to $242 million in the second quarter of 2015.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $949 million for the second quarter
of 2016 compared to $1,110 million for the same period in 2015. The
change was primarily driven by a decrease in upfront collaboration
expenses compared to the previous year, partially offset by early
research and clinical trial activity related to the acquisitions of
Receptos, Inc. and Quanticel Pharmaceuticals, Inc. that closed in the
second half of 2015. Adjusted R&D expenses were $601 million for the
second quarter of 2016 compared to $477 million for the second quarter
of 2015. Adjusted R&D does not include upfront collaboration expenses
but does reflect the increase in early research and clinical trial
activity.
Selling, General, and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $732 million for the second quarter
of 2016 compared to $617 million for the same period in 2015. The
increase was primarily due to a loss contingency accrual expense of $100
million related to a contractual dispute. Adjusted SG&A expenses were
$547 million for the second quarter of 2016 compared to $541 million for
the second quarter of 2015.
Cash, Cash Equivalents, and Marketable Securities
Operating cash flow was $936 million in the second quarter of 2016.
Celgene ended the quarter with approximately $6.4 billion in cash, cash
equivalents and marketable securities.
In the second quarter of 2016, Celgene purchased approximately 3.4
million of its shares at a total cost of approximately $343 million. In
June 2016, the share repurchase authorization was increased by an
additional authorization of $3 billion. As of June 30, 2016, the Company
had approximately $5.1 billion remaining under the stock repurchase
program.
2016 Guidance Updated
|
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Previous 2016 Guidance
|
Updated 2016 Guidance
|
Net Product Sales
|
|
|
Total
|
$10.75B-$11.0B
|
Approximately $11.0B
|
REVLIMID®
|
Approximately $6.7B
|
Approximately $6.8B
|
GAAP diluted EPS
|
$4.26 to $4.56
|
$3.82 to $4.05
|
Adjusted diluted EPS
|
$5.60 to $5.70
|
$5.70 to $5.75
|
GAAP operating margin
|
Approximately 42%
|
Approximately 37%
|
Adjusted operating margin
|
Approximately 53.5%
|
Approximately 54.0%
|
Weighted average diluted shares
|
811M
|
806M
|
Net product sales guidance for POMALYST®/IMNOVID®,
ABRAXANE® and OTEZLA® remain unchanged.
Product and Pipeline Updates
Hematology/Oncology
-
At the American Society of Clinical Oncology (ASCO) meeting in June,
pooled data from a meta-analysis of overall survival (OS) in multiple
myeloma patients receiving REVLIMID® as maintenance
treatment following autologous stem-cell transplant were presented. An
application was submitted to the European Medicines Agency (EMA) in
early June for the review of REVLIMID® as maintenance
treatment in newly diagnosed multiple myeloma (NDMM) patients after
receiving an autologous stem-cell transplant. A decision on the
application is expected in 2017. A submission in the U.S. is expected
in the second half of 2016.
-
In July, the European Commission (EC) approved REVLIMID®
for the treatment of adult patients with relapsed or refractory mantle
cell lymphoma. REVLIMID® is approved in the U.S. for the
treatment of mantle cell lymphoma after relapse or progression on two
prior therapies.
-
In June, the U.S. product insert for POMALYST® was updated
to include data from a pooled pharmacokinetics analysis of patients
with relapsed and/or refractory multiple myeloma (RRMM) and impaired
renal function. In Europe, the Committee for Medicinal Products for
Human Use (CHMP) granted a positive opinion for IMNOVID®
based on the same data. The EC decision is expected in the third
quarter.
-
In July, Celgene disclosed the top-line results of the phase III
REMARC trial evaluating REVLIMID® as maintenance therapy
compared with placebo in patients with diffuse large B-cell lymphoma
responding to treatment with rituximab in combination with standard
chemotherapy. The full data set will be presented at a future medical
congress.
-
In July, Celgene's partner Juno Therapeutics provided preliminary data
from the ongoing phase I trial with JCAR017 in patients with adult
non-Hodgkin lymphoma (NHL). In ten patients evaluable for efficacy, an
overall response rate of 80 percent and a complete response rate of 70
percent were seen. In thirteen patients evaluable for safety, the rate
of severe neurotoxicity was 15 percent and the rate of cytokine
release syndrome was zero percent. An update of the trial data is
expected later in the year.
-
The FUSIONTM program evaluating durvalumab in hematological
malignancies continues to advance with six early-stage trials
enrolling. The trials are evaluating durvalumab as a single agent or
in combination with novel agents in NDMM, RRMM, myelodysplastic
syndromes, acute myeloid leukemia, NHL and chronic lymphocytic
leukemia.
-
A phase II trial with CC-486 in combination with pembrolizumab in
previously treated locally advanced or metastatic non-small cell lung
cancer completed enrollment in the second quarter.
Inflammation & Immunology
-
Long-term data from the PALACE program evaluating OTEZLA®
in moderate-to-severe psoriatic arthritis were presented at the
European League Against Rheumatism (EULAR) meeting in June. Included
was three-year pooled efficacy and safety data from the phase III
PALACE program, as well as pooled data on fatigue, HAQ-DI and BASDAI
from PALACE 1-3.
-
The phase II proof-of-concept trial evaluating OTEZLA® in
atopic dermatitis has completed. Celgene is evaluating the data to
determine next steps. The data will be published at a later date.
-
In May, the phase II TOUCHSTONE trial evaluating ozanimod induction
and maintenance in patients with moderate-to-severe ulcerative colitis
was published in The New England Journal of Medicine.
Histologic data from the phase II TOUCHSTONE trial were presented at
the Digestive Disease Week meeting in May. The phase III TRUE NORTH
trial evaluating ozanimod in patients with moderate-to-severe
ulcerative colitis continues to enroll with data expected in 2018.
-
The registration-enabling endoscopy trial (CD-001) with GED-0301 in
patients with active Crohn's disease completed enrollment. Top-line
data from the 12-week portion of the trial is expected in the second
half of 2016.
Business Update
-
In July, Celgene announced a strategic collaboration with Jounce
Therapeutics, Inc. The collaboration includes options on Jounce's lead
product candidate, JTX-2011, targeting ICOS (the Inducible T cell
CO-Stimulator), and up to four early-stage programs to be selected
from a defined pool of B cell, T regulatory cell and tumor-associated
macrophage targets emerging from Jounce's research platform, and an
additional option on a Jounce checkpoint immuno-oncology program.
-
In May, Celgene and Agios Pharmaceuticals, Inc. entered into a new
global strategic collaboration for the discovery, development and
commercialization of novel metabolic immuno-oncology therapies based
on Agios' innovative cellular metabolism research platform. In
addition, Celgene transferred global development and commercialization
rights to the AG-120 program to Agios.
Second Quarter 2016 Conference Call and Webcast
Information
Celgene will host a conference call to discuss the second quarter of
2016 operational and financial performance on Thursday, July 28, 2016,
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 July 28, 2016,
until midnight ET August 4, 2016. To access the replay in the U.S., dial
(855) 859-2056; outside the U.S. dial (404) 537-3406. The participant
passcode is 43057627.
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® 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 Statements
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.
In addition to financial information prepared in accordance with U.S.
GAAP, this press release also contains adjusted financial measures that
we believe provide investors and management with supplemental
information relating to operating performance and trends that facilitate
comparisons between periods and with respect to projected information.
These adjusted financial measures are non-GAAP and should be
considered in addition to, but not as a substitute for, the information
prepared in accordance with U.S. GAAP. We typically exclude certain GAAP
items that management does not believe affect our basic operations and
that do not meet the GAAP definition of unusual or non-recurring items.
Other companies may define these measures in different ways. 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 six-month periods ended June 30,
2016 and 2015, and for the projected amounts for the year ending
December 31, 2016.
Celgene Corporation and Subsidiaries
|
Condensed Consolidated Statements of Income
|
(Unaudited)
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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Three-Month Periods Ended
|
|
|
Six-Month Periods Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$ 2,744.5
|
|
$ 2,254.1
|
|
|
$ 5,239.2
|
|
$ 4,309.3
|
Other revenue
|
|
9.8
|
|
23.7
|
|
|
26.7
|
|
49.3
|
|
Total revenue
|
|
2,754.3
|
|
2,277.8
|
|
|
5,265.9
|
|
4,358.6
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of
|
|
|
|
|
|
|
|
|
|
|
acquired intangible assets)
|
|
110.9
|
|
100.8
|
|
|
216.8
|
|
204.8
|
Research and development
|
|
948.7
|
|
1,110.0
|
|
|
1,681.9
|
|
1,616.0
|
Selling, general and administrative
|
|
732.1
|
|
616.8
|
|
|
1,275.1
|
|
1,146.0
|
Amortization of acquired intangible assets
|
|
174.8
|
|
63.7
|
|
|
266.6
|
|
127.3
|
Acquisition related charges and restructuring, net
|
(35.9)
|
|
(29.3)
|
|
|
0.3
|
|
(10.3)
|
|
Total costs and expenses
|
|
1,930.6
|
|
1,862.0
|
|
|
3,440.7
|
|
3,083.8
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
823.7
|
|
415.8
|
|
|
1,825.2
|
|
1,274.8
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income, net
|
|
7.2
|
|
8.8
|
|
|
14.0
|
|
17.8
|
Interest (expense)
|
|
(123.3)
|
|
(48.3)
|
|
|
(245.2)
|
|
(97.5)
|
Other income (expense), net
|
|
(12.5)
|
|
94.5
|
|
|
22.7
|
|
102.8
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
695.1
|
|
470.8
|
|
|
1,616.7
|
|
1,297.9
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
96.9
|
|
114.6
|
|
|
217.8
|
|
222.8
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ 598.2
|
|
$ 356.2
|
|
|
$ 1,398.9
|
|
$ 1,075.1
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
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Net income per common share:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ 0.77
|
|
$ 0.45
|
|
|
$ 1.80
|
|
$ 1.35
|
|
Diluted
|
|
$ 0.75
|
|
$ 0.43
|
|
|
$ 1.74
|
|
$ 1.30
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
775.6
|
|
793.0
|
|
|
778.1
|
|
796.0
|
|
Diluted
|
|
801.5
|
|
825.3
|
|
|
804.7
|
|
829.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Balance sheet items:
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents & marketable securities
|
$ 6,403.7
|
|
$ 6,551.9
|
|
|
|
|
|
|
Total assets*
|
|
26,562.0
|
|
26,964.4
|
|
|
|
|
|
|
Long-term debt*
|
|
14,312.1
|
|
14,161.4
|
|
|
|
|
|
|
Total stockholders' equity
|
|
5,548.8
|
|
5,919.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Total assets and long-term debt as of December 31, 2015 have been
adjusted to reflect the retroactive adoption of ASU 2015-03 in the
first quarter of 2016. ASU 2015-03 requires the presentation of debt
issuance costs as a reduction of long-term debt.
|
Celgene Corporation and Subsidiaries
|
Reconciliation of GAAP to Adjusted Net Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended
|
Six-Month Periods Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
Net income - GAAP
|
|
$ 598.2
|
|
$ 356.2
|
|
$ 1,398.9
|
|
$ 1,075.1
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization
|
|
|
|
|
|
|
|
|
|
of acquired intangible assets):
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
(1)
|
8.6
|
|
8.1
|
|
17.6
|
|
14.8
|
|
|
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
(1)
|
63.9
|
|
63.6
|
|
126.1
|
|
119.8
|
|
Upfront collaboration expense
|
(2)
|
284.0
|
|
569.5
|
|
364.0
|
|
588.5
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
(1)
|
85.0
|
|
76.0
|
|
160.3
|
|
141.9
|
|
Litigation-related loss contingency accrual expense
|
(3)
|
100.0
|
|
-
|
|
100.0
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
(4)
|
174.8
|
|
63.7
|
|
266.6
|
|
127.3
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related (gains) charges and restructuring, net:
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
(5)
|
(43.7)
|
|
(29.3)
|
|
(10.7)
|
|
(10.3)
|
|
Restructuring charges
|
(6)
|
7.8
|
|
-
|
|
11.0
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Net income tax adjustments
|
(7)
|
(126.7)
|
|
(89.0)
|
|
(217.6)
|
|
(147.3)
|
Net income - Adjusted
|
|
$ 1,151.9
|
|
$ 1,018.8
|
|
$ 2,216.2
|
|
$ 1,909.8
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - Adjusted
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ 1.49
|
|
$ 1.28
|
|
$ 2.85
|
|
$ 2.40
|
|
Diluted
|
|
$ 1.44
|
|
$ 1.23
|
|
$ 2.75
|
|
$ 2.30
|
|
|
|
|
|
|
|
|
|
|
In addition to financial information prepared in accordance with
U.S. GAAP, this press release also contains adjusted financial
measures that we believe provide investors and management with
supplemental information relating to operating performance and
trends that facilitate comparisons between periods and with respect
to projected information. These adjusted financial measures are
non-GAAP and should be considered in addition to, but not as a
substitute for, the information prepared in accordance with U.S.
GAAP. We typically exclude certain GAAP items that management does
not believe affect our basic operations and that do not meet the
GAAP definition of unusual or non-recurring items. Other companies
may define these measures in different ways.
|
|
|
|
|
Explanation of adjustments:
|
|
(1)
|
|
Exclude share-based compensation expense totaling $157.5 for the
three-month period ended June 30, 2016 and $147.7 for the
three-month period
|
|
|
ended June 30, 2015. Exclude share-based compensation expense
totaling $304.0 for the six-month period ended June 30, 2016 and
$276.5 for the
|
|
|
six-month period ended June 30, 2015.
|
|
|
|
|
|
(2)
|
|
Exclude upfront payment expense for research and development
collaboration arrangements.
|
|
|
|
(3)
|
|
Exclude loss contingency accrual expense related to a contractual
dispute.
|
|
|
|
(4)
|
|
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). The excluded
amortization
|
|
|
expense for the three- and six-month periods ended June 30, 2016
includes $83.1 million related to the impairment of an intangible
asset
|
|
|
acquired in the Avila acquisition.
|
|
|
|
|
|
(5)
|
|
Exclude changes in the fair value of contingent consideration
related to the acquisitions of Gloucester, Abraxis, Avila, Nogra
Pharma Limited and
|
|
|
Quanticel.
|
|
|
|
|
|
(6)
|
|
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.
|
|
|
|
|
|
(7)
|
|
Net income tax adjustments reflect the estimated tax effect of the
above adjustments and the impact of certain other non-operating tax
adjustments,
|
|
|
including the effects of acquisition related matters, adjustments to
the amount of unrecognized tax benefits, and adjustments related to
the gain on
|
|
|
the sale of certain assets.
|
|
Celgene Corporation and Subsidiaries
|
Reconciliation of Full-Year 2016 Projected GAAP to Adjusted Net
Income
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range
|
|
|
|
Low
|
|
High
|
|
|
|
|
|
|
Projected net income - GAAP
|
(1)
|
$ 3,074.9
|
|
$ 3,266.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired intangible
assets):
|
|
Share-based compensation expense
|
|
37.0
|
|
35.2
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
Share-based compensation expense
|
|
263.4
|
|
250.9
|
|
Upfront collaboration expense
|
|
601.0
|
|
601.0
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
Share-based compensation expense
|
|
334.8
|
|
318.9
|
|
Litigation-related loss contingency accrual expense
|
100.0
|
|
100.0
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
458.2
|
|
418.6
|
|
|
|
|
|
|
|
Acquisition related (gains) charges and restructuring, net:
|
|
|
|
Change in fair value of contingent consideration
|
43.7
|
|
39.5
|
|
Restructuring charges
|
|
30.0
|
|
15.0
|
|
|
|
|
|
|
|
Net income tax adjustments
|
|
(348.8)
|
|
(411.1)
|
|
|
|
|
|
|
Projected net income - Adjusted
|
|
$ 4,594.2
|
|
$ 4,634.5
|
|
|
|
|
|
|
Projected net income per diluted common share - GAAP
|
$ 3.82
|
|
$ 4.05
|
|
|
|
|
|
|
Projected net income per diluted common share - Adjusted
|
$ 5.70
|
|
$ 5.75
|
|
|
|
|
|
|
Projected weighted average diluted shares
|
|
806.0
|
|
806.0
|
|
|
|
|
|
|
(1)
|
Our projected 2016 earnings do not include the effect of any
business combinations, collaboration agreements, asset acquisitions,
intangible asset impairments, additional litigation-related loss
contingency accruals or changes in the fair value of our CVRs issued
as part of the acquisition of Abraxis 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 June 30,
|
|
% Change
|
|
|
2016
|
|
2015
|
|
Reported
|
|
Operational(1)
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
$ 1,079.6
|
|
$ 872.6
|
|
23.7%
|
|
23.7%
|
|
0.0%
|
|
International
|
621.2
|
|
571.4
|
|
8.7%
|
|
10.9%
|
|
(2.2)%
|
|
Worldwide
|
1,700.8
|
|
1,444.0
|
|
17.8%
|
|
18.7%
|
|
(0.9)%
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
174.7
|
|
169.8
|
|
2.9%
|
|
2.9%
|
|
0.0%
|
|
International
|
74.4
|
|
74.4
|
|
0.0%
|
|
2.4%
|
|
(2.4)%
|
|
Worldwide
|
249.1
|
|
244.2
|
|
2.0%
|
|
2.7%
|
|
(0.7)%
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
184.9
|
|
143.6
|
|
28.8%
|
|
28.8%
|
|
0.0%
|
|
International
|
132.8
|
|
90.9
|
|
46.1%
|
|
43.2%
|
|
2.9%
|
|
Worldwide
|
317.7
|
|
234.5
|
|
35.5%
|
|
34.4%
|
|
1.1%
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®(3)
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
216.8
|
|
84.7
|
|
N/A
|
|
N/A
|
|
N/A
|
|
International
|
25.1
|
|
5.0
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
241.9
|
|
89.7
|
|
N/A
|
|
N/A
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
3.6
|
|
5.6
|
|
(35.7)%
|
|
(35.7)%
|
|
0.0%
|
|
International
|
150.5
|
|
146.5
|
|
2.7%
|
|
5.6%
|
|
(2.9)%
|
|
Worldwide
|
154.1
|
|
152.1
|
|
1.3%
|
|
4.1%
|
|
(2.8)%
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
21.7
|
|
22.3
|
|
(2.7)%
|
|
(2.7)%
|
|
0.0%
|
|
International
|
-
|
|
-
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
21.7
|
|
22.3
|
|
(2.7)%
|
|
(2.7)%
|
|
0.0%
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
23.3
|
|
33.8
|
|
(31.1)%
|
|
(31.1)%
|
|
0.0%
|
|
International
|
14.4
|
|
14.1
|
|
2.1%
|
|
5.4%
|
|
(3.3)%
|
|
Worldwide
|
37.7
|
|
47.9
|
|
(21.3)%
|
|
(20.3)%
|
|
(1.0)%
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
18.9
|
|
17.0
|
|
11.2%
|
|
11.2%
|
|
0.0%
|
|
International
|
1.8
|
|
0.9
|
|
100.0%
|
|
107.1%
|
|
(7.1)%
|
|
Worldwide
|
20.7
|
|
17.9
|
|
15.6%
|
|
16.0%
|
|
(0.4)%
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
-
|
|
0.9
|
|
N/A
|
|
N/A
|
|
N/A
|
|
International
|
0.8
|
|
0.6
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
0.8
|
|
1.5
|
|
N/A
|
|
N/A
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
1,723.5
|
|
1,350.3
|
|
27.6%
|
|
27.6%
|
|
0.0%
|
|
International
|
1,021.0
|
|
903.8
|
|
13.0%
|
|
14.6%
|
|
(1.6)%
|
|
Worldwide
|
$ 2,744.5
|
|
$ 2,254.1
|
|
21.8%
|
|
22.5%
|
|
(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)
|
- OTEZLA® was approved in the U.S. for Psoriatic
Arthritis in March 2014 and approved in the U.S. for Psoriasis in
|
|
September 2014. OTEZLA® was approved for Psoriatic
Arthritis and Plaque Psoriasis in the EU in January 2015.
|
Celgene Corporation and Subsidiaries
|
Net Product Sales
|
(In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Month Periods
|
|
|
Ended June 30,
|
|
% Change
|
|
|
2016
|
|
2015
|
|
Reported
|
|
Operational(1)
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
$ 2,076.1
|
|
$ 1,683.4
|
|
23.3%
|
|
23.3%
|
|
0.0%
|
|
International
|
1,198.3
|
|
1,103.5
|
|
8.6%
|
|
11.8%
|
|
(3.2)%
|
|
Worldwide
|
3,274.4
|
|
2,786.9
|
|
17.5%
|
|
18.8%
|
|
(1.3)%
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
318.5
|
|
328.9
|
|
(3.2)%
|
|
(3.2)%
|
|
0.0%
|
|
International
|
155.5
|
|
138.7
|
|
12.1%
|
|
14.5%
|
|
(2.4)%
|
|
Worldwide
|
474.0
|
|
467.6
|
|
1.4%
|
|
2.1%
|
|
(0.7)%
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
355.6
|
|
272.0
|
|
30.7%
|
|
30.7%
|
|
0.0%
|
|
International
|
236.1
|
|
161.0
|
|
46.6%
|
|
45.2%
|
|
1.4%
|
|
Worldwide
|
591.7
|
|
433.0
|
|
36.7%
|
|
36.2%
|
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®(3)
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
391.6
|
|
144.1
|
|
N/A
|
|
N/A
|
|
N/A
|
|
International
|
45.9
|
|
5.9
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
437.5
|
|
150.0
|
|
N/A
|
|
N/A
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
7.1
|
|
11.5
|
|
(38.3)%
|
|
(38.3)%
|
|
0.0%
|
|
International
|
293.7
|
|
284.2
|
|
3.3%
|
|
7.3%
|
|
(4.0)%
|
|
Worldwide
|
300.8
|
|
295.7
|
|
1.7%
|
|
5.6%
|
|
(3.9)%
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
40.2
|
|
42.9
|
|
(6.3)%
|
|
(6.3)%
|
|
0.0%
|
|
International
|
-
|
|
-
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
40.2
|
|
42.9
|
|
(6.3)%
|
|
(6.3)%
|
|
0.0%
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
50.8
|
|
66.2
|
|
(23.3)%
|
|
(23.3)%
|
|
0.0%
|
|
International
|
27.9
|
|
28.6
|
|
(2.4)%
|
|
2.0%
|
|
(4.4)%
|
|
Worldwide
|
78.7
|
|
94.8
|
|
(17.0)%
|
|
(15.7)%
|
|
(1.3)%
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
35.6
|
|
32.2
|
|
10.6%
|
|
10.6%
|
|
0.0%
|
|
International
|
3.6
|
|
2.2
|
|
63.6%
|
|
72.5%
|
|
(8.9)%
|
|
Worldwide
|
39.2
|
|
34.4
|
|
14.0%
|
|
14.6%
|
|
(0.6)%
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
1.2
|
|
2.7
|
|
N/A
|
|
N/A
|
|
N/A
|
|
International
|
1.5
|
|
1.3
|
|
N/A
|
|
N/A
|
|
N/A
|
|
Worldwide
|
2.7
|
|
4.0
|
|
N/A
|
|
N/A
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
3,276.7
|
|
2,583.9
|
|
26.8%
|
|
26.8%
|
|
0.0%
|
|
International
|
1,962.5
|
|
1,725.4
|
|
13.7%
|
|
16.4%
|
|
(2.7)%
|
|
Worldwide
|
$ 5,239.2
|
|
$ 4,309.3
|
|
21.6%
|
|
22.7%
|
|
(1.1)%
|
(1)
|
- Operational includes impact from both volume and price
|
(2)
|
- Currency includes the impact from both foreign exchange rates and
hedging activities
|
(3)
|
- OTEZLA® was approved in the U.S. for Psoriatic
Arthritis in March 2014 and approved in the U.S. for Psoriasis in
|
|
September 2014. OTEZLA® was approved for Psoriatic
Arthritis and Plaque Psoriasis in the EU in January 2015.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160728005734/en/
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|