[July 23, 2015] |
|
Celgene Reports Second Quarter 2015 Operating and Financial Results
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
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Condensed Consolidated Statements of Income
|
(Unaudited)
|
(In millions, except per share data)
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended
|
|
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|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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/
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|