- REVLIMID® Net Product Sales $1,444
Million; Increased 19% Y/Y
- POMALYST®/IMNOVID® Net Product Sales
$235 Million; Increased 46% Y/Y
- ABRAXANE® Net Product Sales $244
Million; Increased 13% Y/Y
- OTEZLA® Net Product Sales $90
Million
Celgene Corporation (NASDAQ:CELG) reported net product sales of
$2,254 million for the second quarter of 2015, a 22 percent
increase from the same period in 2014. The negative net impact of
currency on net product sales was 2 percent. Second quarter total
revenue increased 22 percent to $2,278 million compared to $1,873
million in the second quarter of 2014. Adjusted net income for the
second quarter of 2015 increased 36 percent to $1,019 million
compared to $748 million in the second quarter of 2014. Adjusted
diluted earnings per share (EPS) in the second quarter of 2015 was
$1.23 which includes a $0.06 gain related to the sale of an equity
investment upon completion of their acquisition by another company.
For the same period in 2014, adjusted diluted EPS was $0.90.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
Celgene reported second quarter of 2015 net income of $356 million
or $0.43 per diluted share. For the second quarter of 2014, net
income was $598 million or $0.72 per diluted share.
“The Celgene team delivered exceptional results across the
portfolio in the second quarter,” said Bob Hugin, Chairman and
Chief Executive Officer of Celgene Corporation. “We continue to
invest strategically in the long-term future of Celgene and expect
our recently announced transactions with AstraZeneca, Juno and
Receptos to accelerate our earnings growth beginning in 2019.”
Second Quarter 2015 Financial
Highlights
Unless otherwise stated, all comparisons are for the second
quarter of 2015 compared to the second quarter of 2014. The
adjusted operating expense categories presented below exclude
share-based employee compensation expense and upfront collaboration
payments. 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 19 percent to $1,444 million and were driven by volume in
both the U.S. and International markets, increased duration of
therapy and continued market share leadership in multiple myeloma.
U.S. sales of $873 million and International sales of $571 million
increased 22 percent and 15 percent, respectively.
- ABRAXANE® sales for the second quarter
were $244 million, a 13 percent increase. U.S. sales of $170
million and International sales of $74 million increased 6 percent
and 34 percent, respectively. The increase in sales reflects volume
growth in both the U.S. and Europe driven by increased use in
pancreatic cancer.
- POMALYST®/IMNOVID® sales for the second
quarter were $235 million, an increase of 46%. U.S. sales were $144
million and International sales were $91 million, an increase of
38% and 60%, respectively. POMALYST®/IMNOVID® sales were driven by
volume increases globally, increasing duration of treatment and
share gains, as well as geographic expansion, including the launch
in Japan in June.
- VIDAZA® sales in the second quarter
remained flat year-over-year at $152 million. International sales
were $146 million, an increase of 3 percent.
- OTEZLA® sales for the second quarter
were $90 million, increasing 49 percent over the first quarter of
2015. U.S. sales were $85 million and International sales were $5
million. OTEZLA® uptake and market share gains have been strong in
the U.S. since the initial approval in March 2014. Early launch
countries in Europe have begun contributing. Prescription trends
continue to increase.
- All other product sales, which include
THALOMID®, ISTODAX® and an authorized generic of VIDAZA® drug
product in the U.S., were $89 million in the second quarter of 2015
compared to $98 million for the second quarter of 2014.
Research and Development (R&D)
Adjusted R&D expenses were $477 million for the second
quarter of 2015 compared to $397 million for the second quarter of
2014. The increase was primarily due to an increase in clinical
trial activity across the portfolio. On a GAAP basis, R&D
expenses were $1,110 million for the second quarter of 2015 and
$457 million for the same period in 2014 primarily reflecting an
increase in upfront collaboration expenses.
Selling, General, and Administrative (SG&A)
Adjusted SG&A expenses were $541 million for the second
quarter of 2015 compared to $440 million for the second quarter of
2014. The increase was primarily due to investments in support of
the global launches of OTEZLA® in psoriasis and psoriatic arthritis
and REVLIMID® in newly diagnosed multiple myeloma. On a GAAP basis,
SG&A expenses were $617 million for the second quarter of 2015
compared to $492 million for the same period in 2014. The increase
in GAAP SG&A expenses also included an increase in share-based
compensation expense.
Cash, Cash Equivalents, and Marketable Securities
In the second quarter of 2015, Celgene purchased approximately
7.9 million of its shares at a total cost of approximately $902
million. In June, the share repurchase authorization was increased
by an additional $4.0 billion. As of June 30, 2015, the Company had
approximately $5.1 billion remaining authorization under the stock
repurchase program, including the additional $4.0 billion.
Operating cash flow was $284 million in the second quarter of
2015 which included $570 million of upfront payments relating to
research and development collaborations. Celgene ended the quarter
with approximately $7.5 billion in cash, cash equivalents and
marketable securities.
2015 Adjusted EPS Guidance
Raised
- Total net product sales are expected to
be in the range of $9.0 billion to $9.5 billion
- REVLIMID® net sales are expected to be
in the range of $5.6 billion to $5.7 billion
- ABRAXANE® net sales are expected to be
in the range of $1.0 billion to $1.25 billion
- Adjusted diluted EPS is expected to be
in the range of $4.75 to $4.85, up from the original range of $4.60
to $4.75, an increase of approximately 29% over 2014 adjusted
diluted EPS
- GAAP diluted EPS is expected to be in
the range of $2.17 to $2.46, lowered from the original range of
$2.97 to $3.19
Key Accomplishments in First Half of
2015
Hematology
- Received approval for REVLIMID® for the
expanded use in patients newly diagnosed with multiple myeloma in
the U.S. and Europe
- Presented results from the Follicular
Lymphoma Analysis of Surrogacy Hypothesis (FLASH) trial,
co-sponsored by Celgene and Roche, at the American Society of
Clinical Oncology (ASCO) Annual Meeting
- Presented updated overall survival
results from the MM-020/IFM 07-01 FIRST® trial of REVLIMID® in
newly diagnosed multiple myeloma (NDMM) at ASCO and the European
Hematology Association annual congress
- Initiated enrollment in the phase III
ROBUSTTM trial with REVLIMID® in diffuse large B-cell lymphoma
(DLBCL)
- Received approval for POMALYST® in
Japan for the treatment of relapsed and refractory multiple myeloma
(RRMM)
- Announced that accelerated approval
requirements for POMALYST® in the U.S. have been fulfilled and the
U.S. label has been updated with overall survival results from
MM-003
- Announced, in collaboration with
partner Acceleron Pharma, plans to initiate a phase III program
with luspatercept in beta-thalassemia and myelodysplastic syndromes
(MDS) by year-end 2015
- Entered into a strategic collaboration
with AstraZeneca/MedImmune to develop and commercialize durvalumab
for hematologic malignancies and generated a clinical development
plan covering multiple indications with trials to initiate by
year-end
Oncology
- Received approval for ABRAXANE® in
combination with carboplatin in Europe for first-line non-small
cell lung cancer (NSCLC) in adult patients who are not candidates
for potentially curative surgery and/or radiation
- Collaboration partner OncoMed began
enrollment in phase II trials with demcizumab in first-line
advanced-stage NSCLC and pancreatic cancer
- OncoMed presented data from a phase Ib
trial of demcizumab in NSCLC at the European Lung Cancer conference
and presented data from a phase I trial with demcizumab in
pancreatic cancer and NSCLC at ASCO
- Multiple trials with ABRAXANE® in
immune-oncology combinations initiated
- Achieved reimbursement for ABRAXANE®
for pancreatic cancer and NSCLC in key European markets
Inflammation & Immunology
- Received approval in Europe for OTEZLA®
for use in adult patients with moderate-to-severe chronic plaque
psoriasis who failed to respond to or who have a contraindication
to, or are intolerant to other systemic therapy including
cyclosporine, methotrexate or psoralen and ultraviolet-A light and
active psoriatic arthritis who have had an inadequate response or
who have been intolerant to disease modifying antirheumatic
drugs
- Presented data from the phase III
LIBERATETM (PSOR-010) trial with OTEZLA® at the American Academy of
Dermatology
- Published data from the phase II
(BCT-001) trial of OTEZLA® in Behçet’s disease in The New England
Journal of Medicine
- Achieved the primary endpoint for
PSOR-011, a trial to support registration for OTEZLA® in Japan
- Submitted OTEZLA® for approval in
Turkey for Behçet's disease
- Achieved primary endpoint in the phase
III trial PSA-006 evaluating OTEZLA® in TNF-alpha naïve
patients
- Completed enrollment in AD-001, a phase
II trial of OTEZLA® in atopic dermatitis
- Initiated the registration-enabling
endoscopy trial with GED-0301 in Crohn’s disease
- Published data from a phase II trial of
GED-0301 in Crohn’s disease in The New England Journal of
Medicine
- Presented post-hoc subgroup analysis
from the phase II trial of GED-0301 in active Crohn’s disease at
the Digestive Disease Week annual meeting
- Received Orphan Drug Designation from
the U.S. Food and Drug Administration for GED-0301 for the
treatment of pediatric Crohn's disease
- Announced the signing of an agreement
to acquire Receptos, Inc. for $232.00 per share, or a total of
approximately $7.2 billion, net of cash acquired
Research and Early Development
- Filed four Investigational New Drug
(IND) applications
- Initiated phase I trials with CC-90002
(anti-CD47 antibody) in multiple myeloma and solid tumors
- Initiated CC-486 in phase II trials for
metastatic breast cancer and nasopharyngeal cancer and a phase I
trial for DLBCL
- Initiated phase I trial with CC-90003
(selective ERK inhibitor) in relapsed and refractory solid
tumors
- Initiated phase I trial with CC-90005
(selective PKC theta inhibitor) in healthy volunteers and patients
with moderate-to-severe plaque psoriasis
- Exercised option to obtain an exclusive
license outside the U.S. for Agios’ AG-120
- Entered into a joint worldwide
development and profit share agreement for Agios’ AG-881 and
initiated phase I trial with AG-881 in IDH-1 and/or IDH-2 mutated
hematologic malignancies and solid tumors
- Announced agreement to acquire
privately-held biotechnology company Quanticel Pharmaceuticals
Inc.
- Announced global collaboration with
Lycera that includes an exclusive option to license the company’s
portfolio of ex vivo
- Entered into a strategic collaboration
with Juno Therapeutics to develop and commercialize novel
immunotherapies for the treatment of cancer and autoimmune
diseases
Key Milestones Expected During the
Second Half of 2015
Hematology & Oncology
- Regulatory decision on REVLIMID® for
NDMM in Japan
- Submission of REVLIMID® for non-del5q
MDS in the U.S. and Japan
- Complete enrollment in the phase III
CONTINUUM® trial with REVLIMID® for chronic lymphocytic
leukemia
- Regulatory decision in Europe on
REVLIMID® for relapsed and refractory mantle cell lymphoma
- Opinion from the EU Committee for
Medicinal Products for Human Use on VIDAZA® for elderly acute
myeloid leukemia (AML)
- Initiate CC-122 in phase I/II trials in
DLBCL
- Initiate pivotal program for
luspatercept in beta-thalassemia and MDS
- Initiate pivotal program for AG-221 in
AML with IDH-2 mutation
Inflammation & Immunology
- Complete enrollment in
registration-enabling endoscopy trial with GED-0301 in Crohn’s
disease
- Initiate enrollment in the phase III
trials of GED-0301 in Crohn’s disease
- Initiate enrollment in a phase II trial
of GED-0301 in ulcerative colitis
- Complete enrollment in a phase II trial
with CC-220 in systemic lupus erythematosus
- Close acquisition of Receptos
Second Quarter 2015 Conference Call and
Webcast Information
Celgene will host a conference call to discuss the second
quarter of 2015 operational and financial performance on Thursday,
July 23, 2015, 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 23, 2015, until midnight ET July 30, 2015.
To access the replay in the U.S., dial (855) 859-2056; outside the
U.S. dial (404) 537-3406. The participant passcode is 82289992.
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 gene and protein regulation. For more information, please
visit www.celgene.com. Follow Celgene on Social Media: @Celgene,
Pinterest, LinkedIn 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 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 VIDAZA®
In the U.S., VIDAZA® (azacitidine for injection) is indicated
for treatment of patients with the following
French-American-British (FAB) myelodysplastic syndrome subtypes:
refractory anemia (RA) or refractory anemia with ringed
sideroblasts (RARS) (if accompanied by neutropenia or
thrombocytopenia or requiring transfusions), refractory anemia with
excess blasts (RAEB), refractory anemia with excess blasts in
transformation (RAEB-T), and chronic myelomonocytic leukemia
(CMMoL).
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, 2015
and 2014, and for the projected amounts for the year ending
December 31, 2015.
Celgene Corporation and Subsidiaries Condensed
Consolidated Statements of Income (Unaudited) (In
millions, except per share data)
Three-Month Periods Ended
Six-Month Periods Ended June 30, June 30,
2015
2014 2015 2014 Net
product sales $ 2,254.1 $ 1,844.6 $ 4,309.3 $ 3,552.1 Other revenue
23.7 28.1 49.3 50.6 Total
revenue 2,277.8 1,872.7 4,358.6
3,602.7 Cost of goods sold (excluding amortization of
acquired intangible assets) 100.8 98.9 204.8 185.0 Research and
development 1,110.0 456.9 1,616.0 1,170.6 Selling, general and
administrative 616.8 491.8 1,146.0 985.9 Amortization of acquired
intangible assets 63.7 65.3 127.3 131.0 Acquisition related (gains)
charges, net (29.3 ) 0.9 (10.3)
9.5 Total costs and expenses 1,862.0 1,113.8
3,083.8 2,482.0 Operating income 415.8
758.9 1,274.8 1,120.7 Interest and investment income, net
8.8 7.3 17.8 13.7 Interest (expense) (48.3 ) (41.6 ) (97.5) (70.9)
Other income (expense), net 94.5 (17.8 )
102.8 (24.4) Income before income taxes 470.8
706.8 1,297.9 1,039.1 Income tax provision 114.6
109.0 222.8 161.6 Net
income $ 356.2 $ 597.8 $ 1,075.1 $ 877.5
Net income per common share: Basic $ 0.45 $ 0.75 $ 1.35 $
1.09 Diluted $ 0.43 $ 0.72 $ 1.30 $ 1.05 Weighted average
shares: Basic 793.0 799.6 796.0 805.5 Diluted 825.3 831.0 829.7
838.0 June 30, December 31, 2015
2014
Balance sheet items: Cash, cash equivalents
& marketable securities $ 7,492.2 $ 7,546.7 Total assets
17,745.7 17,340.1 Short-term borrowings and current portion of
long-term debt 1,362.9 605.9 Long-term debt 6,256.1 6,265.7 Total
stockholders' equity 6,321.9 6,524.8
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,
2015 2014 2015 2014 Net income - GAAP $ 356.2 $ 597.8 $
1,075.1 $ 877.5 Before tax adjustments: Cost of goods sold
(excluding amortization of acquired intangible assets): Share-based
compensation expense (1) 8.1 5.9 14.8 12.0 Research and
development: Share-based compensation expense (1) 63.6 45.8 119.8
92.8 Upfront collaboration expense (2) 569.5 14.0 588.5 323.0
Selling, general and administrative: Share-based
compensation expense (1) 76.0 51.7 141.9 103.0 Settlement of
contingent obligation (3) - - - 25.0 Amortization of
acquired intangible assets (4) 63.7 65.3 127.3 131.0
Acquisition related (gains) charges, net: Change in fair value of
contingent consideration (5) (29.3) 0.9 (10.3) 9.5 Net
income tax adjustments (6) (89.0) (33.5) (147.3) (121.0) Net income
- Adjusted $ 1,018.8 $ 747.9 $ 1,909.8 $ 1,452.8 Net income
per common share - Adjusted Basic $ 1.28 $ 0.94 $ 2.40 $ 1.80
Diluted $ 1.23 $ 0.90 $ 2.30 $ 1.73 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 $147.7 for the
three-month period ended June 30, 2015 and $103.4 for the
three-month period ended June 30, 2014. Exclude share-based
compensation expense totaling $276.5 for the six-month period ended
June 30, 2015 and $207.8 for the six-month period ended June 30,
2014. (2) Exclude upfront payment expense for research and
development collaboration arrangements. (3) Exclude settlement of a
contingent obligation to make matching contributions to a
non-profit organization. (4) Exclude amortization of intangible
assets acquired in the acquisitions of Pharmion Corp., Gloucester
Pharmaceuticals, Inc. (Gloucester), Abraxis BioScience Inc.
(Abraxis) and Celgene Avilomics Research, Inc. (Avila). (5) Exclude
changes in the fair value of contingent consideration related to
the acquisitions of Gloucester, Abraxis, Avila and Nogra Pharma
Limited. (6) 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, adjustments related to the gain on the sale of an equity
investment and nonrecurring items connected with the launch of new
products.
Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2015 Projected GAAP to Adjusted Net
Income (In millions, except per share data)
Range Low
High Projected net income - GAAP (1 ) $
1,798.9 $ 2,042.5 Before tax adjustments: Cost of goods sold
(excluding amortization of acquired intangible assets): Share-based
compensation expense 30.9 29.7 Research and development:
Share-based compensation expense 257.7 247.5 Upfront collaboration
expense 1,158.8 1,067.5 Selling, general and administrative:
Share-based compensation expense 302.0 290.2 Amortization of
acquired intangible assets 254.6 254.6 Acquisition related
(gains) charges, net: Change in fair value of contingent
consideration 62.6 51.2 Acquisition related charges 336.3 304.3
Net income tax adjustments (259.3) (262.0)
Projected net income - Adjusted $ 3,942.5 $ 4,025.5
Projected net income per diluted common share - GAAP $ 2.17 $ 2.46
Projected net income per diluted common share - Adjusted $
4.75 $ 4.85 Projected weighted average diluted shares 830.0
830.0
(1)
Our projected 2015 earnings do not include the effect of any
business combinations, collaboration agreements, asset
acquisitions, intangible asset impairments, or changes in the fair
value of our CVRs issued as part of the acquisition of Abraxis that
may occur or be announced after the date of this press release.
Celgene Corporation and Subsidiaries Net Product
Sales (In millions)
Three-Month Periods Ended June 30,
% Change 2015
2014
Reported
Operational(1)
Currency(2)
REVLIMID® U.S. $ 872.6 $
716.2 21.8% 21.8% 0.0% International 571.4 497.5
14.9% 20.5% (5.6)% Worldwide 1,444.0 1,213.7 19.0% 21.3% (2.3)%
ABRAXANE® U.S. 169.8 159.9 6.2% 6.2% 0.0%
International 74.4 55.4 34.3% 34.2% 0.1% Worldwide
244.2 215.3 13.4% 13.4% 0.0%
POMALYST®/IMNOVID® U.S. 143.6 104.2
37.8% 37.8% 0.0% International 90.9 56.7 60.3% 60.5%
(0.2)% Worldwide 234.5 160.9 45.7% 45.8% (0.1)%
VIDAZA® U.S. 5.6 9.7 (42.3)% (42.3)% 0.0%
International 146.5 142.3 3.0% 8.2% (5.2)% Worldwide
152.1 152.0 0.1% 4.9% (4.8)%
azacitidine for
injection U.S. 22.3 24.4 -8.6% -8.6% 0.0% International
- - N/A N/A N/A Worldwide 22.3 24.4 -8.6% -8.6% 0.0%
OTEZLA®(3) U.S. 84.7 4.6 N/A N/A N/A International
5.0 - N/A N/A N/A Worldwide 89.7 4.6 N/A N/A N/A
THALOMID® U.S. 33.8 36.5 (7.4)% (7.4)% 0.0%
International 14.1 17.8 (20.8)% (12.4)% (8.4)%
Worldwide 47.9 54.3 (11.8)% (9.1)% (2.7)%
ISTODAX® U.S. 17.0 16.3 4.3% 4.3% 0.0% International
0.9 0.8 12.5% 12.0% 0.5% Worldwide 17.9 17.1 4.7%
4.7% 0.0%
All Other U.S. 0.9 1.4 N/A N/A N/A
International 0.6 0.9 N/A N/A N/A Worldwide 1.5 2.3
N/A N/A N/A
Total Net Product Sales U.S. 1,350.3
1,073.2 25.8% 25.8% 0.0% International 903.8 771.4
17.2% 21.9% (4.7)% Worldwide $ 2,254.1 $ 1,844.6 22.2% 24.2% (2.0)%
(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 2015 2014
Reported Operational(1)
Currency(2)
REVLIMID® U.S. $ 1,683.4 $
1,358.0 24.0% 24.0% 0.0% International 1,103.5 999.5 10.4% 15.4%
(5.0)% Worldwide 2,786.9 2,357.5 18.2% 20.3% (2.1)%
ABRAXANE® U.S. 328.9 301.4 9.1% 9.1% 0.0%
International 138.7 98.7 40.5% 39.7% 0.8% Worldwide 467.6 400.1
16.9% 16.7% 0.2%
POMALYST®/IMNOVID® U.S. 272.0 192.9
41.0% 41.0% 0.0% International 161.0 103.6 55.4% 54.3% 1.1%
Worldwide 433.0 296.5 46.0% 45.6% 0.4%
VIDAZA®
U.S. 11.5 24.3 (52.7)% (52.7)% 0.0% International 284.2 276.1 2.9%
7.6% (4.7)% Worldwide 295.7 300.4 (1.6)% 2.7% (4.3)%
azacitidine for injection U.S. 42.9 42.8 0.2% 0.2% 0.0%
International - - N/A N/A N/A Worldwide 42.9 42.8 0.2% 0.2% 0.0%
OTEZLA®(3) U.S. 144.1 4.6 N/A N/A N/A
International 5.9 - N/A N/A N/A Worldwide 150.0 4.6 N/A N/A N/A
THALOMID® U.S. 66.2 76.5 (13.5)% (13.5)% 0.0%
International 28.6 35.8 (20.1)% (12.6)% (7.5)% Worldwide 94.8 112.3
(15.6)% (13.2)% (2.4)%
ISTODAX® U.S. 32.2 31.2
3.2% 3.2% 0.0% International 2.2 2.0 10.0% 13.0% (3.0)% Worldwide
34.4 33.2 3.6% 3.8% (0.2)%
All Other U.S. 2.7 3.2 N/A
N/A N/A International 1.3 1.5 N/A N/A N/A Worldwide 4.0 4.7 N/A N/A
N/A
Total Net Product Sales U.S. 2,583.9 2,034.9
27.0% 27.0% 0.0% International 1,725.4 1,517.2 13.7% 17.8% (4.1)%
Worldwide $ 4,309.3 $ 3,552.1 21.3% 23.1% (1.8)% (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/20150723005604/en/
Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Vice President, Investor RelationsorMedia:Brian P.
Gill, 908-673-9530Vice President, Corporate Communications
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