- Data from at Least 18 Phase III Trials
Expected from Mid-2016 Through Mid-2018
- 2016 Guidance for Total Net Product
Sales, REVLIMID® Net Sales and Diluted EPS
Celgene Corporation (NASDAQ:CELG) reported operating results for
the fourth quarter and full year of 2015. For the fourth quarter of
2015, net product sales were $2,539 million compared to $2,055
million from the same period in 2014, an increase of 24 percent.
The net negative impact of currency on net product sales was 1
percent. Fourth quarter total revenue increased 23 percent to
$2,563 million compared to $2,085 million in the fourth quarter of
2014. Adjusted net income for the fourth quarter of 2015 increased
14 percent to $961 million compared to $840 million in the fourth
quarter of 2014. For the same period, adjusted diluted earnings per
share (EPS) increased 17 percent to $1.18 from $1.01 and includes a
$0.07 impact from a $70 million milestone achieved by OncoMed
Pharmaceuticals, Inc. during the quarter.
Net product sales for the full year of 2015 were $9,161 million
compared to $7,564 million for the full year of 2014, an increase
of 21 percent. Total revenue for the full year of 2015 was $9,256
million compared to $7,670 million for the previous year, an
increase of 21 percent. Adjusted net income increased 25 percent to
$3,882 million compared to the prior year. Adjusted diluted EPS
increased 27 percent to $4.71 from $3.71 for the full year of
2014.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
Celgene reported net income of $561 million and diluted EPS of
$0.69 for the fourth quarter of 2015. For the fourth quarter of
2014, GAAP net income was $614 million and diluted EPS was $0.74.
Full year GAAP net income for 2015 was $1,602 million and diluted
EPS was $1.94. Full year GAAP net income for 2014 was $2,000
million and diluted EPS was $2.39.
“Celgene delivered outstanding operating and financial results
in 2015. Our extraordinary operating momentum and key regulatory
approvals in 2015 increase our prospects for significant growth in
2016 and beyond,” said Bob Hugin, Chairman and Chief Executive
Officer of Celgene Corporation. “In 2016, we will continue to
leverage our global operations and advance our deep and diverse
pipeline to accelerate the next generation of transformational
medicines.”
Fourth Quarter and Full Year 2015
Financial Highlights
Unless otherwise stated, all comparisons are for the fourth
quarter and full year of 2015 compared to the fourth quarter and
full year of 2014. The adjusted operating expense categories
presented below exclude share-based employee compensation expense,
in-process research and development (IPR&D) impairments,
upfront collaboration payments and settlement of contingent
obligations. Please see the attached Reconciliation of GAAP to
Adjusted Net Income for further information.
Net Product Sales Performance
- REVLIMID® sales for the fourth quarter
increased 18 percent to $1,561 million and were driven by increased
duration of therapy in the U.S. and market share gains in newly
diagnosed multiple myeloma (NDMM) in Europe. Fourth quarter U.S.
sales of $956 million and international sales of $605 million
increased 20 percent and 15 percent, respectively. Full year
REVLIMID® sales were $5,801 million, an increase of 16
percent.
- POMALYST®/IMNOVID® sales for the fourth
quarter were $294 million. Fourth quarter U.S. sales of $170
million and international sales of $124 million increased 29
percent and 77 percent, respectively. Full year POMALYST®/IMNOVID®
sales were $983 million. Sales were driven by increased market
share and duration gains.
- ABRAXANE® sales for the fourth quarter
were $270 million, an increase of 14 percent. U.S. sales were $180
million and international sales were $90 million, an increase of 5
percent and 41 percent, respectively. Full year ABRAXANE® sales
were $967 million, an increase of 14 percent.
- OTEZLA® sales in the fourth quarter
were $183 million. Full year OTEZLA® sales were $472 million.
OTEZLA® uptake and market share gains continued to accelerate in
the fourth quarter in the U.S. with increased contribution from
early launch countries in Europe.
- In the fourth quarter, all other
product sales, which include THALOMID®, ISTODAX®, VIDAZA® and an
authorized generic version of VIDAZA® drug product in the U.S.,
were $231 million compared to $248 million in the fourth quarter of
2014. Full year sales for these products were $938 million.
Research and Development (R&D)
Adjusted R&D expenses were $649 million for the fourth
quarter of 2015 compared to $478 million for the fourth quarter of
2014. The fourth quarter of 2015 included a $70 million milestone
achieved by OncoMed Pharmaceuticals, Inc. and also reflected
increased clinical trial activity for pipeline programs.
For the full year of 2015, adjusted R&D expenses were $2,044
million compared to $1,651 million for the full year of 2014.
Adjusted R&D expenses included expenses related to advancing
clinical trials and expenses for collaboration-related payments to
partners.
On a GAAP basis, R&D expenses were $777 million for the
fourth quarter of 2015 versus $585 million for the same period in
2014. The year-over-year increase in R&D expenses on a GAAP
basis was primarily due to an increase in clinical trial activity.
Full year of 2015 R&D expenses were $3,697 million compared to
$2,431 million for 2014. The increase in R&D expenses on a GAAP
basis was primarily due to upfront payments for collaboration
arrangements and an increase in clinical trial activity, partially
offset by an impairment recorded in the prior year.
Selling, General, and Administrative (SG&A)
Adjusted SG&A expenses were $533 million for the fourth
quarter of 2015 compared to $479 million for the fourth quarter of
2014. For the full year of 2015, adjusted SG&A was $2,011
million versus $1,778 million in 2014. The increase was primarily
due to launch expenses related to OTEZLA® in the U.S. and Europe
and the ongoing launch of REVLIMID® for NDMM in Europe.
On a GAAP basis, SG&A expenses were $609 million for the
fourth quarter of 2015 compared to $544 million for the same period
in 2014. Full year SG&A expenses were $2,305 million for 2015
compared to $2,028 million for 2014.
Cash, Cash Equivalents, and Marketable Securities
Operations generated cash flow of $2,483 million for 2015, a
decrease of 12 percent year-over-year, primarily driven by an
increase in upfront collaboration payments. For the full year of
2015, Celgene purchased approximately $3,257 million of shares. As
of December 31, 2015, the Company had $3,890 million remaining
under the existing share repurchase program. The Company ended the
year with $6,552 million in cash and marketable securities.
Product and Pipeline
Updates
Hematology/Oncology
In December 2015, Celgene announced the settlement of
litigations with Natco Pharma Ltd. and its partners and affiliates,
relating to certain patents for REVLIMID®. As part of the
settlement, Celgene agreed to provide Natco with a license to
Celgene’s patents required to manufacture and sell an unlimited
quantity of generic lenalidomide in the U.S. beginning on January
31, 2026. In addition, Natco will receive a volume-limited license
to sell generic lenalidomide in the U.S. commencing in March 2022,
which is expected to be a mid-single-digit percentage of the total
lenalidomide capsules dispensed in the U.S. during the first year
of entry. The volume limitation is expected to increase gradually
each twelve months until March 2025. Natco’s ability to market
generic lenalidomide in the U.S. will be contingent on its
obtaining approval of an Abbreviated New Drug Application.
In December, REVLIMID® was granted full marketing authorization
by Japan's Ministry of Health, Labour and Welfare (MHLW) for use in
combination with dexamethasone as a treatment for patients with
NDMM. This marketing authorization expands upon the approval of
REVLIMID® in 2010 for the treatment of patients with relapsed or
refractory multiple myeloma (RRMM). Reimbursement discussions are
ongoing.
Celgene, in collaboration with partner AstraZeneca, announced
the initiation of the FUSION clinical development program with
durvalumab in hematologic malignancies. The initial trials combine
durvalumab with Celgene assets and novel compounds in RRMM,
myelodysplastic syndromes (MDS), acute myeloid leukemia (AML),
non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia
(CLL). Additional trials in NDMM and diffuse large B-cell lymphoma
(DLBCL) are expected to begin late in the first quarter of
2016.
At the 57th American Society of Hematology Annual Meeting, data
on the combination of REVLIMID®, bortezomib and low-dose
dexamethasone (RVd) in NDMM were presented. In the 471-patient
study, patients receiving RVd achieved a median progression free
survival (PFS) of 43 months compared to a median PFS of 30 months
for patients who received Rd alone (HR = 0.712, 96% CI, one-sided
p=0.0018 (two-sided p=0.0037)). The data also show that overall
survival (OS) was improved for RVd compared to Rd. Patients who
received RVd had a median OS of 75 months compared to a median 64
months for patients receiving Rd (HR=0.709, 96% CI, one-sided
p=0.0125 (two-sided p=0.0250)). In January, the National
Comprehensive Cancer Network (NCCN) added the RVd combination to
the multiple myeloma guidelines as a category 1 preferred treatment
for both stem-cell transplant and non stem-cell transplant
candidates.
Subsequent to our October 2015 supplementary new drug
application filed with the U.S. Food and Drug Administration (FDA)
for the expanded indication of REVLIMID® for the treatment of
non-del 5q lower risk MDS, the FDA requested additional analyses
and data for the submission to further support the risk/benefit
assessment of REVLIMID® in this population. Based on the request,
Celgene has decided to withdraw the submission at this time.
Celgene remains committed to continued development in myeloid
disease with ongoing trials in MDS and AML with CC-486,
luspatercept in collaboration with Acceleron and the IDH platform
in collaboration with Agios.
Data on the combination of ABRAXANE® with chemotherapy and with
anti-PD-L1 compounds in neoadjuvant and triple-negative breast
cancer were presented at the San Antonio Breast Cancer Symposium in
December. Data from the phase III ETNA cooperative group trial with
ABRAXANE® in patients with HER2-negative high-risk breast cancer
are expected to be presented in 2016. Celgene expects to submit
ABRAXANE® for early-stage breast cancer for regulatory approval in
Europe in 2016.
Inflammation & Immunology
In January 2016, Celgene announced that radiographic data from
long-term follow-up from the phase III POSTURE® trial of OTEZLA® in
ankylosing spondylitis showed a delay in disease progression. Based
on this result, Celgene is evaluating the next steps for OTEZLA® in
this disease. The data are expected to be presented at a major
medical congress in 2016.
Results from the two phase III ESTEEM trials (ESTEEM 1 and
ESTEEM 2) in patients with psoriasis were published in the Journal
of the American Academy of Dermatology. At week 16, OTEZLA®
produced greater NAPSI-50 response (50% reduction from baseline in
target Nail Psoriasis Severity Index score) versus placebo (both
studies P < .0001) and ScPGA response (Scalp Physician Global
Assessment score 0 or 1) versus placebo (both studies P <
.0001). Improvements were generally maintained over 52 weeks in
patients with Psoriasis Area and Severity Index response at week
32.
Three year efficacy and safety data of OTEZLA® in patients with
psoriatic arthritis from the phase III PALACE 1 trial were
presented at the American College of Rheumatology meeting in
November. Among patients remaining in the study on treatment at 156
weeks, OTEZLA® demonstrated sustained and clinically meaningful
improvements in ACR 20, ACR 50 and ACR 70 scores with a
well-tolerated safety profile.
In the fourth quarter, a large phase III pivotal trial with
GED-0301 in active Crohn’s disease began enrollment. In addition, a
phase II trial with GED-0301 in ulcerative colitis also began
enrollment. Data from the registration-enabling endoscopic trial
with GED-0301 is expected in 2017. Also in the quarter, the phase
II STEPSTONE trial with ozanimod in Crohn’s disease began
enrollment.
The Group for Research and Assessment of Psoriasis and Psoriatic
Arthritis (GRAPPA) updated their Treatment Recommendations for
Psoriatic Arthritis in 2015. OTEZLA® was included for the first
time in these recommendations including for peripheral arthritis,
enthesitis, dactylitis, psoriasis and nail disease in psoriatic
arthritis.
Business Update
Human Longevity, Inc. (HLI), a genomics and cell therapy-based
diagnostic and therapeutic company based in San Diego, agreed to
purchase Celgene Cellular Therapeutics’ (CCT) biobanking business
known as LifebankUSA and CCT’s biomaterials portfolio of assets
including Biovance. In addition, in this transaction HLI will also
acquire the full rights to PSC-100, a placental stem cell program
which CCT partnered with HLI in August 2014. CCT remains committed
to advancing a pipeline of cell therapy and regenerative medicine
products including PDA-002 in clinical trials for diabetic foot
ulcers and diabetic peripheral neuropathy and PNK-007 (natural
killer (NK) cells) in phase I trials for AML and multiple
myeloma.
Data from at Least 18 Phase III Trials
Expected from Mid-2016 Through Mid-2018
2016
- REMARC trial with REVLIMID® in DLBCL
maintenance
- CONTINUUM® trial with REVLIMID® in CLL
maintenance
- ETNA trial with ABRAXANE® in
neoadjuvant breast cancer
- PSA-006 trial with OTEZLA® in biologic
naïve psoriatic arthritis
2017
- RELEVANCE® trial with REVLIMID® in
first-line follicular lymphoma
- AUGMENT® trial with REVLIMID® in
relapsed and/or refractory follicular lymphoma
- IMpower 130 Roche-sponsored trial with
ABRAXANE® and atezolizumab in non-squamous non-small cell lung
cancer (NSCLC)
- IMpower 131 Roche-sponsored trial with
ABRAXANE® and atezolizumab in squamous NSCLC
- apact® trial with ABRAXANE® in adjuvant
pancreatic cancer
- abound®.sqm with ABRAXANE® in squamous
NSCLC maintenance
- RELIEFTM trial with OTEZLA® in Behçet’s
disease
- SUNBEAM trial with ozanimod in multiple
sclerosis
- RADIANCE trial with ozanimod in
multiple sclerosis
2018
- OPTIMISMM® trial with POMALYST® in
second-line relapsed and/or refractory multiple myeloma
- IMpassion 130 Roche-sponsored trial
with ABRAXANE® and atezolizumab in triple-negative breast
cancer
- CD-002 trial with GED-0301 in Crohn’s
disease
- CD-003 trial with GED-0301 in Crohn’s
disease
- TRUE NORTH trial with ozanimod in
ulcerative colitis
Celgene Expects Strong Product Sales
and Earnings Growth in 2016
- Total net product sales of $10.5
billion to $11.0 billion, an increase of 17 percent year-over-year
based on the mid-point of the range and includes a negative impact
from foreign exchange of approximately $120 million
- REVLIMID® net sales in the range of
$6.6 billion to $6.7 billion, an increase of 15 percent
year-over-year based on the mid-point of the range
- Adjusted operating margin of
approximately 53.5 percent after investments across the entire
organization, a 150 bps improvement over 2015. GAAP operating
margin is expected to be approximately 42 percent
- Adjusted diluted EPS in the range of
$5.50 to $5.70, an increase of approximately 19 percent
year-over-year based on the mid-point of the range. GAAP diluted
EPS is expected to be in the range of $4.26 to $4.64
- Fully diluted share count for the
full-year 2016 of approximately 825 million
- For the first quarter of 2016, adjusted
diluted EPS in the range of $1.27 to $1.30. GAAP diluted EPS is
expected to be in the range of $0.98 to $1.05
Please see the attached Reconciliations of 2016 Projected GAAP
to Adjusted Net Income for further information.
Q4 and Full year 2015 Conference Call and Webcast
Information
Celgene will host a conference call to discuss the fourth
quarter and full-year of 2015 operational and financial performance
on Thursday, January 28, 2016, at 9 a.m. ET. The conference call
will be available by webcast at www.celgene.com. An audio replay of
the call will be available from noon January 28, 2016, until
midnight ET February 4, 2016. To access the replay in the U.S.,
dial 1-855-859-2056; outside the U.S. dial 404-537-3406. The
participant passcode is 11177982.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and
YouTube.
About REVLIMID®
In the U.S., REVLIMID® (lenalidomide) in combination with
dexamethasone is indicated for the treatment of patients with
multiple myeloma. REVLIMID® is indicated for patients with
transfusion-dependent anemia due to Low- or Intermediate-1-risk
myelodysplastic syndromes (MDS) associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic
abnormalities. REVLIMID® is approved in the U.S. for the treatment
of patients with mantle cell lymphoma (MCL) whose disease has
relapsed or progressed after two prior therapies, one of which
included bortezomib. Limitations of Use: REVLIMID® is not indicated
and is not recommended for the treatment of chronic lymphocytic
leukemia (CLL) outside of controlled clinical trials.
About ABRAXANE®
In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound)
is indicated for the treatment of breast cancer after failure of
combination chemotherapy for metastatic disease or relapse within
six months of adjuvant chemotherapy. Prior therapy should have
included an anthracycline unless clinically contraindicated.
ABRAXANE® is indicated for the first-line treatment of locally
advanced or metastatic non-small cell lung cancer, in combination
with carboplatin, in patients who are not candidates for curative
surgery or radiation therapy. ABRAXANE® is also indicated for the
first-line treatment of metastatic adenocarcinoma of the pancreas
in combination with gemcitabine.
About POMALYST®
In the U.S., POMALYST® (pomalidomide) is indicated for patients
with multiple myeloma who have received at least two prior
therapies including lenalidomide and a proteasome inhibitor and
have demonstrated disease progression on or within 60 days of
completion of the last therapy.
About OTEZLA®
In the U.S., OTEZLA® (apremilast) is indicated for the treatment
of adult patients with active psoriatic arthritis. OTEZLA® is
indicated in the U.S. for the treatment of patients with moderate
to severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
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).
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-month and full year periods ended December
31, 2015 and for the projected amounts for the three-month period
ending March 31, 2016 and the year ending December 31, 2016.
Celgene Corporation and
SubsidiariesCondensed Consolidated Statements of
Income(Unaudited)(In millions, except per share
data)
Three-Month Periods Ended
Twelve-Month Periods Ended December 31, December 31, 2015
2014 2015 2014 Net product sales $
2,539.2 $ 2,054.9 $ 9,161.1 $ 7,563.8 Other revenue 24.1
30.6 94.9 106.6 Total revenue 2,563.3
2,085.5 9,256.0 7,670.4 Cost of goods
sold (excluding amortization of acquired intangible assets) 105.4
103.2 420.1 385.9 Research and development 776.8 584.9 3,697.3
2,430.6 Selling, general and administrative 609.1 544.4 2,305.4
2,027.9 Amortization of acquired intangible assets 88.1 63.6 279.0
258.3 Acquisition related charges and restructuring, net
83.7 37.7 299.6 48.7 Total costs and expenses
1,663.1 1,333.8 7,001.4 5,151.4
Operating income 900.2 751.7 2,254.6 2,519.0 Interest and
investment income, net 4.7 7.6 31.1 28.2 Interest (expense) (124.6)
(51.7) (310.6) (176.1) Other income (expense), net (34.8)
3.2 48.4 (43.7) Income before income
taxes 745.5 710.8 2,023.5 2,327.4 Income tax provision
184.5 96.9 421.5 327.5 Net
income $ 561.0 $ 613.9 $ 1,602.0 $ 1,999.9 Net income
per common share: Basic $ 0.71 $ 0.77 $ 2.02 $ 2.49 Diluted $ 0.69
$ 0.74 $ 1.94 $ 2.39 Weighted average shares: Basic 785.8
800.2 792.2 802.7 Diluted 816.5 834.6 824.9 836.0
December 31,
December 31, 2015 2014
Balance sheet items: Cash, cash
equivalents & marketable securities $ 6,551.9 $ 7,546.7 Total
assets 27,053.4 17,340.1 Short-term borrowings and current portion
of long-term debt - 605.9 Long-term debt 14,250.4 6,265.7 Total
stockholders' equity 5,919.0 6,524.8
Celgene Corporation and
SubsidiariesReconciliation of GAAP to Adjusted Net
Income(In millions, except per share data)
Three-Month Periods Ended Twelve-Month Periods
Ended December 31, December 31, 2015 2014 2015 2014 Net
income - GAAP $ 561.0 $ 613.9 $ 1,602.0 $ 1,999.9 Before tax
adjustments: Cost of goods sold (excluding amortization of acquired
intangible assets): Share-based compensation expense (1) 8.4 7.4
31.7 26.2 Research and development: Share-based compensation
expense (1) 65.7 55.3 250.7 196.5 Upfront collaboration expense (2)
62.0 52.0 1,402.3 453.6 IPR&D impairment (3) - - - 129.2
Selling, general and administrative: Share-based compensation
expense (1) 76.1 65.7 294.2 224.9 Settlement of contingent
obligation (4) - - - 25.0 Amortization of acquired
intangible assets (5) 88.1 63.6 279.0 258.3 Acquisition
related (gains) charges and restructuring, net: Change in fair
value of contingent consideration (6) 9.3 37.7 (7.9) 48.7
Acquisition costs (7) 66.0 - 297.6 - Restructuring charges (8) 8.4
- 9.9 - Net income tax adjustments (9) 16.4
(55.4) (277.1) (263.7) Net income - Adjusted $ 961.4
$ 840.2 $ 3,882.4 $ 3,098.6 Net income per common share -
Adjusted Basic $ 1.22 $ 1.05 $ 4.90 $ 3.86 Diluted $ 1.18 $ 1.01 $
4.71 $ 3.71
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 $150.2 for the three-month period ended December 31, 2015
and $128.4 for the three-month
period ended December 31, 2014. Exclude
share-based compensation expense totaling $576.6 for the
twelve-month period ended December 31, 2015
and $447.6 for the twelve-month period
ended December 31, 2014.
(2) Exclude upfront payment expense for research and development
collaboration arrangements. (3) Exclude in-process research and
development (IPR&D) impairment recorded as a result of changes
in estimated probability-weighted cash flows related to CC-292. (4)
Exclude settlement of a contingent obligation to make matching
contributions to a non-profit organization. (5) Exclude
amortization of intangible assets acquired in the acquisitions of
Pharmion Corp., Gloucester Pharmaceuticals, Inc. (Gloucester),
Abraxis BioScience Inc. (Abraxis), Celgene Avilomics Research, Inc.
(Avila), and Quanticel Pharmaceuticals, Inc. (Quanticel). (6)
Exclude changes in the fair value of contingent consideration
related to the acquisitions of Gloucester, Abraxis, Avila, Nogra
Pharma Limited and Quanticel. (7) Exclude equity compensation and
other fees and costs related to the acquisitions of Receptos, Inc.
and Quanticel. (8) Exclude restructuring charges related to our
relocation of certain operations into our two Summit, NJ locations
as well as costs associated with certain headcount reductions. (9)
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
SubsidiariesReconciliation of 2016 Projected GAAP to
Adjusted Net Income(In millions, except per share
data)
Three-Month Period Ending Twelve-Month Period
Ending March 31, 2016 December 31, 2016 Low High Low High
Projected net income - GAAP (1) $ 804.5 $ 859.9 $ 3,517.8 $ 3,827.7
Before tax adjustments: Cost of goods sold (excluding
amortization of acquired intangible assets): Share-based
compensation expense 8.1 7.9 38.7 36.8 Research and
Development: Share-based compensation expense 64.6 63.4 307.5 292.1
Selling, general and administrative: Share-based
compensation expense 76.3 74.7 362.6 344.5 Amortization of
acquired intangible assets 97.1 88.7 388.4 354.8 Acquisition
related charges and restructuring, net: Change in fair value of
contingent consideration 37.2 33.6 136.3 123.3 Restructuring
charges 10.0 5.0 30.0 15.0 Net income tax adjustments (56.4)
(67.2) (243.8) (291.7) Projected net
income - Adjusted $ 1,041.4 $ 1,066.0 $ 4,537.5 $ 4,702.5
Projected net income per diluted common share - GAAP $ 0.98 $ 1.05
$ 4.26 $ 4.64 Projected net income per diluted common share
- Adjusted $ 1.27 $ 1.30 $ 5.50 $ 5.70 Projected weighted
average diluted shares 820.0 820.0 825.0
825.0 (1) Our projected 2016 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.
Celgene Corporation and
SubsidiariesNet Product Sales(In millions)
Three-Month Periods
Ended December 31,
% Change 2015 2014 Reported
Operational(1)
Currency(2)
REVLIMID® U.S. $ 956.3 $ 797.5 19.9% 19.9% 0.0%
International 604.4 525.0 15.1% 18.1% (3.0)%
Worldwide 1,560.7 1,322.5 18.0% 19.2% (1.2)%
ABRAXANE® U.S. 179.5 171.5 4.7% 4.7% 0.0%
International 90.5 64.4 40.5% 39.5% 1.0% Worldwide
270.0 235.9 14.5% 14.2% 0.3%
POMALYST®/IMNOVID® U.S. 169.7 131.8
28.8% 28.8% 0.0% International 124.1 70.3 76.5% 72.2%
4.3% Worldwide 293.8 202.1 45.4% 43.9% 1.5%
OTEZLA®(3) U.S. 167.5 47.6 N/A N/A N/A International
15.5 - N/A N/A N/A Worldwide 183.0 47.6 N/A N/A N/A
VIDAZA® U.S. 4.8 8.8 (45.5)% (45.5)% 0.0%
International 142.6 144.9 (1.6)% 1.5% (3.1)%
Worldwide 147.4 153.7 (4.1)% (1.2)% (2.9)%
azacitidine
for injection U.S. 19.7 15.5 27.1% 27.1% 0.0% International
- - N/A N/A N/A Worldwide 19.7 15.5 27.1% 27.1% 0.0%
THALOMID® U.S. 31.5 40.7 (22.6)% (22.6)% 0.0%
International 14.0 16.3 (14.1)% (9.1)% (5.0)%
Worldwide 45.5 57.0 (20.2)% (18.8)% (1.4)%
ISTODAX® U.S. 16.1 15.9 1.3% 1.3% 0.0% International
1.3 0.8 62.5% 66.9% (4.4)% Worldwide 17.4 16.7 4.2%
4.4% (0.2)%
All Other U.S. 1.0 3.2 N/A N/A N/A
International 0.7 0.7 N/A N/A N/A Worldwide 1.7 3.9
N/A N/A N/A
Total Net Product Sales U.S. 1,546.1
1,232.5 25.4% 25.4% 0.0% International 993.1 822.4
20.8% 22.8% (2.0)% Worldwide $ 2,539.2 $ 2,054.9 23.6% 24.4% (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)
- 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
SubsidiariesNet Product Sales(In millions)
Twelve-Month Periods
Ended December 31, % Change 2015 2014
Reported Operational(1)
Currency(2)
REVLIMID® U.S. $ 3,534.9 $ 2,915.7 21.2% 21.2% 0.0%
International 2,266.2 2,064.3 9.8% 14.2% (4.4)%
Worldwide 5,801.1 4,980.0 16.5% 18.3% (1.8)%
ABRAXANE® U.S. 653.6 624.5 4.7% 4.7% 0.0%
International 313.9 223.7 40.3% 39.5% 0.8% Worldwide
967.5 848.2 14.1% 13.9% 0.2%
POMALYST®/IMNOVID® U.S. 591.8 443.0
33.6% 33.6% 0.0% International 391.5 236.7 65.4%
62.8% 2.6% Worldwide 983.3 679.7 44.7% 43.8% 0.9%
OTEZLA®(3) U.S. 440.0 69.8 N/A N/A N/A International
31.7 - N/A N/A N/A Worldwide 471.7 69.8 N/A N/A N/A
VIDAZA® U.S. 21.2 42.8 (50.5)% (50.5)% 0.0%
International 569.5 569.1 0.1% 4.4% (4.3)% Worldwide
590.7 611.9 (3.5)% 0.5% (4.0)%
azacitidine for
injection U.S. 83.9 78.2 7.3% 7.3% 0.0% International -
- N/A N/A N/A Worldwide 83.9 78.2 7.3% 7.3% 0.0%
THALOMID® U.S. 129.0 152.6 (15.5)% (15.5)% 0.0%
International 56.4 68.6 (17.8)% (11.1)% (6.7)%
Worldwide 185.4 221.2 (16.2)% (14.1)% (2.1)%
ISTODAX® U.S. 64.5 61.4 5.0% 5.0% 0.0% International
4.6 4.2 9.5% 14.9% (5.4)% Worldwide 69.1 65.6 5.3%
5.7% (0.4)%
All Other U.S. 5.7 6.7 N/A N/A N/A
International 2.7 2.5 N/A N/A N/A Worldwide 8.4 9.2
N/A N/A N/A
Total Net Product Sales U.S. 5,524.6
4,394.7 25.7% 25.7% 0.0% International 3,636.5
3,169.1 14.7% 18.2% (3.5)% Worldwide $ 9,161.1 $ 7,563.8 21.1%
22.5% (1.4)% (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/20160128005651/en/
Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice PresidentInvestor RelationsorMedia:Brian
P. Gill, 908-673-9530Vice PresidentCorporate Communications
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