[July 24, 2014] |
|
Celgene Reports Second Quarter 2014 Operating and Financial Results
SUMMIT, N.J. --(Business Wire)--
Celgene Corporation (NASDAQ:CELG) reported net product sales of $1,845
million for the second quarter of 2014, an 18 percent increase from the
same period in 2013. Second quarter total revenue increased 17 percent
to $1,873 million compared to $1,599 million in the second quarter of
2013. Adjusted net income for the second quarter of 2014 increased 15
percent to $748 million compared to $653 million in the second quarter
of 2013. For the same period, adjusted diluted earnings per share (EPS)
increased 18 percent to $0.90 from $0.76, on a split-adjusted basis.
Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene
reported second quarter of 2014 net income of $598 million or $0.72 per
diluted share. For the second quarter of 2013, net income was $478
million or $0.56 per diluted share, on a split-adjusted basis.
"Strong second quarter operating and financial results demonstrate the
significant momentum of our portfolio and support raising our 2014
guidance," said Bob Hugin, Chairman and Chief Executive Officer of
Celgene Corporation. "We look forward to multiple milestones in the
second half of the year, including the expansion of OTEZLA®
into psoriasis and the further advancement of our pipeline."
Second Quarter 2014 Financial Highlights
Unless otherwise stated, all comparisons are for the second quarter of
2014 compared to the second quarter of 2013. The adjusted operating
expense categories presented below exclude share-based employee
compensation expense and upfront collaboration payments. In June 2014,
Celgene effected a two-for-one split of the Company's common stock.
Adjusted diluted EPS, GAAP EPS and share counts for all periods are
split-adjusted. 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 15 percent
to $1,214 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 $716
million and International sales of $498 million increased 15 percent
and 17 percent, respectively.
-
ABRAXANE® sales for the second quarter were $215 million, a
39 percent increase. U.S. sales of $160 million and International
sales of $55 million increased 33 percent and 58 percent,
respectively. The increase in sales reflects the impact of the ongoing
U.S. launch in pancreatic cancer and early launch success for
pancreatic cancer in Europe.
-
VIDAZA® second quarter sales decreased 28 percent to $152
million, reflecting the year-over-year impact of the entry of generic
azacitidine in the U.S. market. U.S. sales decreased 89 percent to $10
million. International sales were $142 million, an increase of 12
percent. International sales were driven by increased demand in Europe
and Japan.
-
POMALYST®/IMNOVID® sales were $161 million, an
increase of 143%. U.S. sales were $104 million and International sales
were $57 million, an increase of 81% and 567%, respectively. POMALYST®/IMNOVID®
sales were driven by market share gains in the U.S. and the strong
commercial launch in Europe following the August 5, 2013 approval.
-
OTEZLA® sales were $5 million. After launching the product
for psoriatic arthritis in early April, underlying demand grew
steadily and OTEZLA® ended the quarter sharing the market
share lead for new patient starts. The overall market access position
is favorable and trending ahead of expectations. During the quarter,
patients initiating therapy received a two-week sample titration pack
and almost half of the patients obtained an additional two weeks of
free product until they gained authorization for reimbursement.
-
All other product sales, which include THALOMID®, ISTODAX®
and an authorized generic of VIDAZA® drug product in the
U.S., were $98 million in the second quarter of 2014 compared to $80
million for the second quarter of 2013.
Research and Development (R&D)
Adjusted R&D expenses were $397 million for the second quarter of 2014
compared to $345 million for the second quarter of 2013. The increase
was primarily due to an increase in clinical trial activity. On a GAAP
basis, R&D expenses were $457 million for the second quarter of 2014 and
$458 million for the same period in 2013 reflecting the increased
clinical trial activity which was offset by lower upfront collaboration
expense.
Selling, General, and Administrative (SG&A)
Adjusted SG&A expenses were $440 million for the second quarter of 2014
compared to $384 million for the second quarter of 2013. The increase
was primarily due to investments in support of the launch of OTEZLA®
for psoriatic arthritis in the U.S., pre-launch activities for OTEZLA®
for psoriasis in the U.S. and pre-launch activities for OTEZLA®
in Europe. On a GAAP basis, SG&A expenses were $492 million for the
second quarter of 2014 compared to $418 million for the same period in
2013. 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 2014, Celgene purchased approximately 3.2
million of its shares on a pre-split basis at a total cost of
approximately $475 million. As of June 30, 2014, the Company had $3,932
million remaining under the stock repurchase program.
In May, the Company priced a series of five-, ten- and thirty-year
senior unsecured notes for an aggregate principal amount of $2,500
million that resulted in $12 million in interest expense in the second
quarter of 2014. In addition, the Company purchased additional equity in
Acceleron Pharma Inc. at a price above market value that resulted in an
expense for the premium of $10 million. The incremental interest expense
and equity premium combined accounted for a $0.02 reduction in adjusted
diluted EPS.
Operating cash flow was $516 million in the second quarter of 2014.
Celgene ended the quarter with $6,213 million in cash, cash equivalents
and marketable securities.
2014 Guidance
-
Total revenue raised to approximately $7,600 million from $7,500
million, an increase of approximately 17 percent year-over-year
-
Total Net Product Sales raised to above $7,500 million from the
previous range of $7,300 million to $7,400 million, an increase of
approximately 18 percent over 2013 Total Net Product Sales
-
REVLIMID® Net Product Sales narrowed to approximately
$4,950 million from the previous range of $4,900 million to $5,000
million, an increase of approximately 16 percent over 2013 REVLIMID®
Net Product Sales
-
ABRAXANE® Net Product Sales expected to be in the range of
$850 million to $900 million
-
Adjusted diluted EPS raised to a range of $3.60 to $3.65 from the
previous range of $3.50 to $3.60, an increase of approximately 22%
over 2013 adjusted diluted EPS
-
GAAP diluted EPS is expected to be in the range of $2.46 to $2.55 from
the previous range of $2.47 to $2.59
Business Update
Celgene announced that Robert Hershberg, M.D., Ph.D. is joining the
Company to lead Celgene's research and early development efforts in
immuno-oncology and a newly formed Celgene Immuno-Oncology Center of
Excellence to be based in Seattle, Washington. His arrival anchors
strategic positioning of the Company's current and expanding
immuno-oncology pipeline assets, including approved IMiD®
products, emerging preclinical assets targeting innate immunity, T-cell
checkpoints and collaborative CAR-T projects. Dr. Hershberg brings a
depth of translational and clinical development experience from former
positions at Corixa, Dendreon, and as founder and current CEO, President
and Director of VentiRx. Dr. Hershberg completed his undergraduate
degree in molecular biology and M.D. at UCLA, and his Ph.D. in Biology
at the Salk Institute.
Key Accomplishments in First Half of 2014
Hematology
-
Submitted REVLIMID® for newly diagnosed multiple myeloma
(NDMM) in the U.S. and Europe. FDA assigned a U.S. Prescription Drug
User Fee Act (PDUFA) goal date of February 22, 2015 for REVLIMID®
in NDMM
-
Completed enrollment in the phase III REMARC trial with REVLIMID®
as maintenance in diffuse large B-cell lymphoma (DLBCL)
-
Began enrollment in the phase III AUGMENTTM (NHL-007) trial
with REVLIMID® in relapsed and/or refractory follicular
lymphoma and the phase IIIb MAGNIFYTM (NHL-008) trial with
REVLIMID® in patients with relapsed and/or refractory
indolent lymphoma
-
Presented phase II data on the combination of REVLIMID®
with R-CHOP in patients with non-germinal center (non-GCB) phenotype
newly diagnosed DLBCL at the American Society of Clinical Oncology
meeting
-
Achieved the primary endpoint of progression free survival in the
pivotal randomized phase II MCL-002 trial with REVLIMID® in
patients with relapsed and/or refractory mantle cell lymphoma
-
Achieved the primary endpoint of RBC-transfusion independence for at
least 8 weeks in the phase III MDS-005 trial with REVLIMID®
in patients with non-del5q low-risk/Intermediate-1
transfusion-dependent myelodysplastic syndrome
-
Presented results of the phase III AML-001 trial with VIDAZA®
in elderly patients with newly diagnosed acute myeloid leukemia at the
European Hematology Association (EHA) meeting
-
Data presented from a phase I trial of AG-221 in patients with
advanced hematologic malignancies with an isocitrate dehydrogenase-2
(IDH2) mutation at the American Association for Cancer Research and
EHA meetings. Celgene exercised the option to an exclusive worldwide
license to AG-221 in June
-
Data presented from two phase II trials of sotatercept and ACE-536 in
patients with both transfusion dependent and non-transfusion dependent
beta-thalassemia at the EHA meeting
Oncology
-
Began enrollment in the phase III APACT (PANC-003) trial with ABRAXANE®
as an adjuvant treatment in patients with surgically resected
pancreatic cancer
-
Began enrollment in a phase III trial with ABRAXANE® as
maintenance therapy in patients with squamous cell non-small cell lung
cancer (NSCLC)
-
Began enrollment in a phase II trial with ABRAXANE® in
patients with previously treated metastatic colorectal cancer. The
trial will stratify patients with regards to RAS wild-type and RAS
mutation
-
Data presented from a phase Ib study of demcizumab in combination with
pemetrexed and carboplatin in patients with first-line non-squamous
NSCLC at the ASCO meeting
Inflammation & Immunology
-
Received approval from the U.S. FDA in March for OTEZLA®
for the treatment of adult patients with active psoriatic arthritis
-
Presented data on OTEZLA® from the ESTEEM 1 and ESTEEM 2
phase III trials in patients with moderate-to-severe psoriasis at the
American Academy of Dermatology meeting
-
Presented long-term data on OTEZLA® from the PALACE program
in patients with active psoriatic arthritis at the European League
Against Rheumatism meeting
-
Announced the results of the phase III trial of OTEZLA® in
patients with active ankylosing spondylitis
-
Initiated a phase II trial with OTEZLA® in patients with
atopic dermatitis
-
Acquired late-stage product GED-0301 for moderate-to-severe Crohn's
disease and other indications
-
Data presented from a phase IIa trial with sotatercept in patients
with end-stage renal disease on hemodialysis at the National Kidney
Foundation meeting
Key Milestones Expected During the Second Half
of 2014
Hematology & Oncology
-
Present data from the MDS-005 phase III trial
-
Present data from the MCL-002 phase II trial
-
Present data from a phase II trial with sotatercept in MDS
-
Initiate a phase I trial with CC-486 in DLBCL
-
Initiate phase III trial with REVLIMID® for the treatment
of non-GCB DLBCL with a companion diagnostic
-
Initiate phase I/II trials with ABRAXANE® in combination
with anti-PD1 antibodies in multiple solid tumors
-
Initiate a phase Ib trial with CC-122 in hepatocellular cancer
-
Initiate a phase I trial with CC-486 in solid tumors
Inflammation & Immunology
-
U.S. PDUFA goal date for OTEZLA® in moderate-to-severe
psoriasis is September 23
-
Opinion from the Committee for Medicinal Products for Human Use (CHMP)
for OTEZLA® in active psoriatic arthritis and
moderate-to-severe psoriasis
-
Complete enrollment of a phase III trial in Japan with OTEZLA®
in active psoriatic arthritis and moderate-to-severe psoriasis
-
Target presentation of two-year data on OTEZLA® in active
psoriatic arthritis from the PALACE program
-
Initiate a phase III trial with OTEZLA® in Behçet's disease
-
Initiate a phase IIb trial with OTEZLA® in ulcerative
colitis
-
Present and publish phase II data on GED-0301 in Crohn's disease. Data
to be presented at United European Gastroenterology Week in Vienna on
October 21
-
Data on sotatercept for the treatment of anemia in patients with
chronic kidney disease/mineral and bone disorder
-
Initiate phase IIa trials with CC-220 in systemic lupus erythematosus
and other indications
Second Quarter 2014 Conference Call and Webcast
Information
Celgene will host a conference call to discuss the second quarter of
2014 operating and financial performance on Thursday, July 24, 2014, 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 24, 2014,
until midnight ET July 31, 2014. To access the replay in the U.S., dial
(855) 859-2056. Outside the U.S. dial (404) 537-3406. The participant
passcode is 23334020. The Company's third quarter of 2014 financial and
operational results are expected to be reported on October 23.
About REVLIMID®
In the U.S., REVLIMID® (lenalidomide) in combination with
dexamethasone is indicated for the treatment of multiple myeloma (MM)
patients who have received at least one prior therapy. 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 bortezomib and have demonstrated
disease progression on or within 60 days of completion of the last
therapy. Approval is based on response rate. Clinical benefit such as
improvement in survival or symptoms has not been verified.
About OTEZLA®
In the U.S., OTEZLA® (apremilast) is indicated for the
treatment of adult patients with active psoriatic arthritis.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of novel therapies for the
treatment of cancer and inflammatory diseases through gene and protein
regulation. For more information, please visit www.celgene.com.
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 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 Adjusted Net Income and
Adjusted Earnings Per Share amounts for the three-and six-month periods
ended June 30, 2014 and 2013, and for the projected amounts for the year
ending December 31, 2014.
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries Condensed
Consolidated Statements of Income (Unaudited) (In
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended June 30,
|
|
|
Six-Month Periods Ended June 30,
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
$
|
1,844.6
|
|
|
|
$
|
1,564.1
|
|
|
|
$
|
3,552.1
|
|
|
|
$
|
2,993.4
|
|
Other revenue
|
|
|
|
28.1
|
|
|
|
|
34.9
|
|
|
|
|
50.6
|
|
|
|
|
70.2
|
|
Total revenue
|
|
|
|
1,872.7
|
|
|
|
|
1,599.0
|
|
|
|
|
3,602.7
|
|
|
|
|
3,063.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of
|
|
|
|
|
|
|
|
|
|
|
|
|
acquired intangible assets)
|
|
|
|
98.9
|
|
|
|
|
80.9
|
|
|
|
|
185.0
|
|
|
|
|
161.4
|
|
Research and development
|
|
|
|
456.9
|
|
|
|
|
458.1
|
|
|
|
|
1,170.6
|
|
|
|
|
910.5
|
|
Selling, general and administrative
|
|
|
|
491.8
|
|
|
|
|
418.1
|
|
|
|
|
985.9
|
|
|
|
|
787.1
|
|
Amortization of acquired intangible assets
|
|
|
|
65.3
|
|
|
|
|
65.7
|
|
|
|
|
131.0
|
|
|
|
|
131.4
|
|
Acquisition related charges, net
|
|
|
|
0.9
|
|
|
|
|
12.5
|
|
|
|
|
9.5
|
|
|
|
|
45.7
|
|
Total costs and expenses
|
|
|
|
1,113.8
|
|
|
|
|
1,035.3
|
|
|
|
|
2,482.0
|
|
|
|
|
2,036.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
|
758.9
|
|
|
|
|
563.7
|
|
|
|
|
1,120.7
|
|
|
|
|
1,027.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
|
(52.1
|
)
|
|
|
|
(5.9
|
)
|
|
|
|
(81.6
|
)
|
|
|
|
(21.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
|
706.8
|
|
|
|
|
557.8
|
|
|
|
|
1,039.1
|
|
|
|
|
1,006.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
|
|
109.0
|
|
|
|
|
79.7
|
|
|
|
|
161.6
|
|
|
|
|
143.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
$
|
597.8
|
|
|
|
$
|
478.1
|
|
|
|
$
|
877.5
|
|
|
|
$
|
863.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share:(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
0.75
|
|
|
|
$
|
0.58
|
|
|
|
$
|
1.09
|
|
|
|
$
|
1.04
|
|
Diluted
|
|
|
$
|
0.72
|
|
|
|
$
|
0.56
|
|
|
|
$
|
1.05
|
|
|
|
$
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares:(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
799.6
|
|
|
|
|
828.2
|
|
|
|
|
805.5
|
|
|
|
|
832.0
|
|
Diluted
|
|
|
|
831.0
|
|
|
|
|
858.5
|
|
|
|
|
838.0
|
|
|
|
|
861.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2014
|
|
|
December 31, 2013
|
|
|
|
|
|
|
Balance sheet items:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents & marketable securities
|
|
|
$
|
6,213.0
|
|
|
|
$
|
5,687.0
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
15,601.9
|
|
|
|
|
13,378.2
|
|
|
|
|
|
|
|
Short-term borrowings
|
|
|
|
192.3
|
|
|
|
|
544.8
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
|
6,743.3
|
|
|
|
|
4,196.5
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
|
4,851.3
|
|
|
|
|
5,589.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
Following stockholder approval, the Company amended its
certificate of incorporation on June 18, 2014, to increase the
number of authorized shares of common stock from 575.0 million to
1.150 billion and effect a two-for-one stock split of its
outstanding common stock. Accordingly, all share and per share
amounts presented herein reflect the impact of the stock split.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries Reconciliation
of GAAP to Adjusted Net Income (In millions, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended June 30,
|
|
|
Six-Month Periods Ended June 30,
|
|
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income - GAAP
|
|
|
|
|
$
|
597.8
|
|
|
|
$
|
478.1
|
|
|
|
$
|
877.5
|
|
|
|
$
|
863.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
of acquired intangible assets):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
|
|
5.9
|
|
|
|
|
3.7
|
|
|
|
|
12.0
|
|
|
|
|
6.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
|
|
45.8
|
|
|
|
|
31.8
|
|
|
|
|
92.8
|
|
|
|
|
58.8
|
|
Upfront collaboration expense
|
|
(2
|
)
|
|
|
|
14.0
|
|
|
|
|
81.8
|
|
|
|
|
323.0
|
|
|
|
|
177.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
(1
|
)
|
|
|
|
51.7
|
|
|
|
|
34.3
|
|
|
|
|
103.0
|
|
|
|
|
70.1
|
|
Settlement of contingent obligation
|
|
(3
|
)
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
25.0
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
(4
|
)
|
|
|
|
65.3
|
|
|
|
|
65.7
|
|
|
|
|
131.0
|
|
|
|
|
131.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related charges, net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
(5
|
)
|
|
|
|
0.9
|
|
|
|
|
12.5
|
|
|
|
|
9.5
|
|
|
|
|
45.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income tax adjustments
|
|
(6
|
)
|
|
|
|
(33.5
|
)
|
|
|
|
(55.0
|
)
|
|
|
|
(121.0
|
)
|
|
|
|
(108.4
|
)
|
Net income - Adjusted
|
|
|
|
|
$
|
747.9
|
|
|
|
$
|
652.9
|
|
|
|
$
|
1,452.8
|
|
|
|
$
|
1,244.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - Adjusted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
$
|
0.94
|
|
|
|
$
|
0.79
|
|
|
|
$
|
1.80
|
|
|
|
$
|
1.50
|
|
Diluted
|
|
|
|
|
$
|
0.90
|
|
|
|
$
|
0.76
|
|
|
|
$
|
1.73
|
|
|
|
$
|
1.44
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 $103.4 for the
three-month period ended June 30, 2014 and $69.8 for the
three-month period ended June 30, 2013. Exclude share-based
compensation expense totaling $207.8 for the six-month period
ended June 30, 2014 and $135.4 for the six-month period ended June
30, 2013.
|
(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,
and nonrecurring items connected with the launch of new products.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries Net Product
Sales (In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods
|
|
|
|
Ended June 30,
|
|
|
% Change
|
|
|
|
|
2014
|
|
|
2013
|
|
|
Reported
|
|
|
Operational(1)
|
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
$
|
716.2
|
|
|
$
|
624.6
|
|
|
14.7
|
%
|
|
|
14.7
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
497.5
|
|
|
|
426.9
|
|
|
16.5
|
%
|
|
|
14.2
|
%
|
|
|
2.3
|
%
|
Worldwide
|
|
|
|
1,213.7
|
|
|
|
1,051.5
|
|
|
15.4
|
%
|
|
|
14.5
|
%
|
|
|
0.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
159.9
|
|
|
|
119.8
|
|
|
33.5
|
%
|
|
|
33.5
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
55.4
|
|
|
|
35.0
|
|
|
58.3
|
%
|
|
|
58.0
|
%
|
|
|
0.3
|
%
|
Worldwide
|
|
|
|
215.3
|
|
|
|
154.8
|
|
|
39.1
|
%
|
|
|
39.0
|
%
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
9.7
|
|
|
|
84.4
|
|
|
(88.5
|
)%
|
|
|
(88.5
|
)%
|
|
|
0.0
|
%
|
International
|
|
|
|
142.3
|
|
|
|
126.9
|
|
|
12.1
|
%
|
|
|
10.4
|
%
|
|
|
1.7
|
%
|
Worldwide
|
|
|
|
152.0
|
|
|
|
211.3
|
|
|
(28.1
|
)%
|
|
|
(29.1
|
)%
|
|
|
1.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
104.2
|
|
|
|
57.7
|
|
|
80.6
|
%
|
|
|
80.6
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
56.7
|
|
|
|
8.5
|
|
|
567.1
|
%
|
|
|
572.1
|
%
|
|
|
(5.0
|
)%
|
Worldwide
|
|
|
|
160.9
|
|
|
|
66.2
|
|
|
143.1
|
%
|
|
|
143.7
|
%
|
|
|
(0.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
36.5
|
|
|
|
46.1
|
|
|
(20.8
|
)%
|
|
|
(20.8
|
)%
|
|
|
0.0
|
%
|
International
|
|
|
|
17.8
|
|
|
|
20.1
|
|
|
(11.4
|
)%
|
|
|
(13.0
|
)%
|
|
|
1.6
|
%
|
Worldwide
|
|
|
|
54.3
|
|
|
|
66.2
|
|
|
(18.0
|
)%
|
|
|
(18.5
|
)%
|
|
|
0.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
24.4
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
24.4
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
16.3
|
|
|
|
12.1
|
|
|
34.7
|
%
|
|
|
34.7
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
0.8
|
|
|
|
1.4
|
|
|
(42.9
|
)%
|
|
|
(46.3
|
)%
|
|
|
3.4
|
%
|
Worldwide
|
|
|
|
17.1
|
|
|
|
13.5
|
|
|
26.7
|
%
|
|
|
26.3
|
%
|
|
|
0.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
4.6
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
4.6
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
1.4
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
0.9
|
|
|
|
0.6
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
2.3
|
|
|
|
0.6
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
1,073.2
|
|
|
|
944.7
|
|
|
13.6
|
%
|
|
|
13.6
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
771.4
|
|
|
|
619.4
|
|
|
24.5
|
%
|
|
|
22.6
|
%
|
|
|
1.9
|
%
|
Worldwide
|
|
|
$
|
1,844.6
|
|
|
$
|
1,564.1
|
|
|
17.9
|
%
|
|
|
17.1
|
%
|
|
|
0.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
- Operational includes impact from both volume and price
|
(2)
|
|
|
- Currency includes the impact from both foreign exchange rates and
hedging activities
|
(3)
|
|
|
- POMALYST® was approved in the U.S. on February 8, 2013;
IMNOVID® was approved in the EU on August 5, 2013
|
(4)
|
|
|
- OTEZLA® was approved in the U.S. on March 21, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries Net Product
Sales (In millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six-Month Periods
|
|
|
|
Ended June 30,
|
|
|
% Change
|
|
|
|
2014
|
|
|
2013
|
|
|
Reported
|
|
|
Operational(1)
|
|
|
Currency(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVLIMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
$
|
1,358.0
|
|
|
$
|
1,192.9
|
|
|
13.8
|
%
|
|
|
13.8
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
999.5
|
|
|
|
861.4
|
|
|
16.0
|
%
|
|
|
14.7
|
%
|
|
|
1.3
|
%
|
Worldwide
|
|
|
|
2,357.5
|
|
|
|
2,054.3
|
|
|
14.8
|
%
|
|
|
14.2
|
%
|
|
|
0.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ABRAXANE®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
301.4
|
|
|
|
213.5
|
|
|
41.2
|
%
|
|
|
41.2
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
98.7
|
|
|
|
64.0
|
|
|
54.2
|
%
|
|
|
53.3
|
%
|
|
|
0.9
|
%
|
Worldwide
|
|
|
|
400.1
|
|
|
|
277.5
|
|
|
44.2
|
%
|
|
|
44.0
|
%
|
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIDAZA®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
24.3
|
|
|
|
171.1
|
|
|
(85.8
|
)%
|
|
|
(85.8
|
)%
|
|
|
0.0
|
%
|
International
|
|
|
|
276.1
|
|
|
|
244.3
|
|
|
13.0
|
%
|
|
|
11.9
|
%
|
|
|
1.1
|
%
|
Worldwide
|
|
|
|
300.4
|
|
|
|
415.4
|
|
|
(27.7
|
)%
|
|
|
(28.4
|
)%
|
|
|
0.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
POMALYST®/IMNOVID®(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
192.9
|
|
|
|
79.5
|
|
|
142.6
|
%
|
|
|
142.6
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
103.6
|
|
|
|
15.2
|
|
|
581.6
|
%
|
|
|
588.1
|
%
|
|
|
(6.5
|
)%
|
Worldwide
|
|
|
|
296.5
|
|
|
|
94.7
|
|
|
213.1
|
%
|
|
|
214.2
|
%
|
|
|
(1.1
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THALOMID®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
76.5
|
|
|
|
81.5
|
|
|
(6.1
|
)%
|
|
|
(6.1
|
)%
|
|
|
0.0
|
%
|
International
|
|
|
|
35.8
|
|
|
|
42.1
|
|
|
(15.0
|
)%
|
|
|
(15.7
|
)%
|
|
|
0.7
|
%
|
Worldwide
|
|
|
|
112.3
|
|
|
|
123.6
|
|
|
(9.1
|
)%
|
|
|
(9.4
|
)%
|
|
|
0.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
azacitidine for injection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
42.8
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
42.8
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ISTODAX®
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
31.2
|
|
|
|
24.2
|
|
|
28.9
|
%
|
|
|
28.9
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
2.0
|
|
|
|
2.2
|
|
|
(9.1
|
)%
|
|
|
(12.0
|
)%
|
|
|
2.9
|
%
|
Worldwide
|
|
|
|
33.2
|
|
|
|
26.4
|
|
|
25.8
|
%
|
|
|
25.6
|
%
|
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTEZLA®(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
4.6
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
-
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
4.6
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
3.2
|
|
|
|
-
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
International
|
|
|
|
1.5
|
|
|
|
1.5
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Worldwide
|
|
|
|
4.7
|
|
|
|
1.5
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
2,034.9
|
|
|
|
1,762.7
|
|
|
15.4
|
%
|
|
|
15.4
|
%
|
|
|
0.0
|
%
|
International
|
|
|
|
1,517.2
|
|
|
|
1,230.7
|
|
|
23.3
|
%
|
|
|
22.1
|
%
|
|
|
1.2
|
%
|
Worldwide
|
|
|
$
|
3,552.1
|
|
|
$
|
2,993.4
|
|
|
18.7
|
%
|
|
|
18.2
|
%
|
|
|
0.5
|
%
|
(1)
|
|
|
- Operational includes impact from both volume and price
|
(2)
|
|
|
- Currency includes the impact from both foreign exchange rates and
hedging activities
|
(3)
|
|
|
- POMALYST® was approved in the U.S. on February 8, 2013;
IMNOVID® was approved in the EU on August 5, 2013
|
(4)
|
|
|
- OTEZLA® was approved in the U.S. on March 21, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celgene Corporation and Subsidiaries Reconciliation
of Full-Year 2014 Projected GAAP to Adjusted Net Income (In
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Range
|
|
|
|
|
|
Low
|
|
|
High
|
|
|
|
|
|
|
|
|
|
Projected net income - GAAP
|
|
(1
|
)
|
|
|
$
|
2,058.0
|
|
|
|
$
|
2,130.1
|
|
|
|
|
|
|
|
|
|
|
Before tax adjustments:
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization of acquired
|
|
|
|
|
|
|
|
|
intangible assets):
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
27.0
|
|
|
|
|
26.7
|
|
|
|
|
|
|
|
|
|
|
Research and Development:
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
207.8
|
|
|
|
|
205.7
|
|
Upfront collaboration expense
|
|
|
|
|
|
323.0
|
|
|
|
|
323.0
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative:
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
232.9
|
|
|
|
|
230.6
|
|
Settlement of contingent obligation
|
|
|
|
|
|
25.0
|
|
|
|
|
25.0
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
|
|
|
|
258.3
|
|
|
|
|
258.3
|
|
|
|
|
|
|
|
|
|
|
Acquisition related charges, net:
|
|
|
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
|
|
|
|
67.4
|
|
|
|
|
66.0
|
|
|
|
|
|
|
|
|
|
|
Net income tax adjustments
|
|
|
|
|
|
(193.4
|
)
|
|
|
|
(217.6
|
)
|
|
|
|
|
|
|
|
|
|
Projected net income - Adjusted
|
|
|
|
|
$
|
3,006.0
|
|
|
|
$
|
3,047.8
|
|
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - GAAP
|
|
|
|
|
$
|
2.46
|
|
|
|
$
|
2.55
|
|
|
|
|
|
|
|
|
|
|
Projected net income per diluted common share - Adjusted
|
|
|
|
|
$
|
3.60
|
|
|
|
$
|
3.65
|
|
|
|
|
|
|
|
|
|
|
Projected weighted average diluted shares
|
|
|
|
|
|
835.0
|
|
|
|
|
835.0
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
|
Our projected 2014 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
after the day prior to the date of this press release.
|
|
|
|
|
[ Back To TMCnet.com's Homepage ]
|