- Net Product Sales of $2.95B in Q1:17;
Increased 18% Y/Y
- REVLIMID® Net Product Sales of $1.9B in
Q1:17; Increased 20% Y/Y
- Raising 2017 EPS Guidance
- Positive phase II STEPSTONE data with
ozanimod in Crohn’s disease; Phase III trial initiation planned by
year-end
Celgene Corporation (NASDAQ:CELG) reported net product sales of
$2,950 million for the first quarter of 2017, an 18 percent
increase from the same period in 2016. Net product sales growth
includes a 0.6 percent negative impact from currency exchange
effects. Celgene reported first quarter of 2017 total revenue of
$2,960 million, an 18 percent increase compared to $2,512 million
in the first quarter of 2016.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
Celgene reported net income of $941 million and diluted earnings
per share (EPS) of $1.16 for the first quarter of 2017. For the
first quarter of 2016, GAAP net income was $801 million and diluted
EPS was $0.99.
Adjusted net income for the first quarter of 2017 increased 28
percent to $1,364 million compared to $1,064 million in the first
quarter of 2016. For the same period, adjusted diluted EPS
increased 27 percent to $1.68 from $1.32.
“Our significant first quarter operational, financial and
strategic progress strengthen our confidence and outlook for 2017,”
said Mark J. Alles, Celgene’s Chief Executive Officer. “Our
business momentum is increasing as we continue to generate
meaningful catalysts and long-term value drivers.”
First Quarter 2017 Financial
Highlights
Unless otherwise stated, all comparisons are for the first
quarter of 2017 compared to the first quarter of 2016. The adjusted
operating expense categories presented below exclude share-based
employee compensation expense, collaboration-related upfront
expense and research and development asset acquisition expense.
Please see the attached Use of Non-GAAP Financial Measures and
Reconciliation of GAAP to Adjusted Net Income for further
information relevant to the interpretation of adjusted financial
measures and reconciliations of these adjusted financial measures
to the most comparable GAAP measures, respectively.
Net Product Sales Performance
- REVLIMID® sales for the first quarter
increased 20 percent to $1,884 million. Sales growth was driven
primarily by increased volume as a result of increases in duration
and market share. U.S. sales of $1,234 million and international
sales of $650 million increased 24 percent and 13 percent
year-over-year, respectively.
- POMALYST®/IMNOVID® sales for the first
quarter were $364 million, an increase of 33 percent
year-over-year. U.S. sales were $216 million and international
sales were $148 million, an increase of 26 percent and 44 percent
year-over-year, respectively. POMALYST®/IMNOVID® sales grew due to
increased volume driven by duration gains.
- OTEZLA® sales for the first quarter
were $242 million, a 24 percent increase year-over-year. First
quarter U.S. sales of $199 million and international sales of $43
million increased 14 percent and 105 percent, respectively, and
were driven by market share gains in the U.S. and continued
international launches.Despite a contraction in the overall market
volume of prescriptions filled, OTEZLA® share in psoriasis grew
versus last quarter. In addition, net sales were impacted by
increasing gross-to-net adjustments related to contracts
implemented in January with several large payers that significantly
broadened access for up to 100 million covered lives.
- ABRAXANE® sales for the first quarter
were $236 million, a 5 percent increase year-over-year. U.S. sales
were $142 million and international sales were $94 million, a
decrease of 1 percent and an increase of 16 percent, respectively.
ABRAXANE® market shares in pancreatic cancer, first-line advanced
non-squamous lung cancer and metastatic breast cancer in the U.S.
are stable. Growth in Europe was driven by market share gains for
ABRAXANE® in pancreatic cancer.
- In the first quarter, all other product
sales, which include THALOMID®, ISTODAX®, VIDAZA® and an authorized
generic version of VIDAZA® drug product in the U.S., were $224
million compared to $226 million in the first quarter of 2016.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $995 million for the
first quarter of 2017 versus $733 million for the same period in
2016. The first quarter increase was due to R&D asset
acquisition expenses primarily related to the acquisition of
Delinia, Inc., that was partially offset by a decrease in
collaboration-related upfront expense.
Adjusted R&D expenses were $595 million for the first
quarter of 2017 compared to $591 million for the first quarter of
2016.
Selling, General, and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $620 million for the
first quarter of 2017 compared to $543 million for the same period
in 2016. Adjusted SG&A expenses were $539 million for the first
quarter of 2017 compared to $468 million for the first quarter of
2016.
Cash, Cash Equivalents, and Marketable Securities
Operating cash flow was $853 million in the first quarter of
2017, compared to $1.0 billion1 for the first quarter of 2016. In
the first quarter, Celgene purchased approximately 2.6 million of
its shares at a total cost of approximately $304 million. As of
March 31, 2017, the Company had approximately $4.4 billion
remaining under the stock repurchase program. Celgene ended the
quarter with approximately $8.9 billion in cash, cash equivalents
and marketable securities.
1 Adjusted as a result of the adoption of ASU 2016-09,
“Compensation-Stock Compensation.”
2017 Guidance
Updated
Previous 2017 Guidance Updated 2017 Guidance
Net Product Sales
REVLIMID(®) $8.0B to $8.3B Unchanged POMALYST(®)/IMNOVID(®)
Approximately $1.6B Unchanged OTEZLA(® )
$1.5B to $1.7B
Unchanged ABRAXANE(®) Approximately $1.0B Unchanged Total Revenue
$13.0B to $13.4B Unchanged GAAP operating margin Approximately
45.5% Approximately 46.0% GAAP diluted EPS $5.85 to $6.21 $5.95 to
$6.29 Adjusted operating margin Approximately 56.5%
Approximately 57.0%
Adjusted diluted EPS $7.10 to $7.25 $7.15 to $7.30 Weighted average
diluted shares Approximately 815M Unchanged
Product and Pipeline
Updates
Hematology/Oncology
- In February, the U.S. Food and Drug
Administration (FDA) and the European Commission (EC) approved the
use of REVLIMID® as a single agent for maintenance therapy in adult
patients with newly diagnosed multiple myeloma (NDMM) following
autologous stem-cell transplantation (ASCT). Celgene is actively
involved in launch activities for this indication in the U.S. and
reimbursement discussions across Europe.
- A New Drug Application (NDA) was filed
with the FDA for IDHIFA® (enasidenib) in relapsed and/or refractory
acute myeloid leukemia (AML) with isocitrate dehydrogenase 2 (IDH2)
mutation. The NDA was granted Priority Review and has been given a
Prescription Drug User Fee Act (PDUFA) action date of August 30,
2017. IDHIFA® is part of Celgene’s global strategic collaboration
with Agios Pharmaceuticals focused on cancer metabolism.
- The phase III OPTIMISMM® trial
evaluating POMALYST®/IMNOVID® in combination with bortezomib and
low-dose dexamethasone versus bortezomib and low-dose dexamethasone
in patients with second-line relapsed and/or refractory multiple
myeloma (RRMM) completed enrollment. Data from the OPTIMISMM® trial
are expected in 2018.
- In April, Celgene’s partner OncoMed
Pharmaceuticals, Inc. provided top-line data from the phase II
YOSEMITE trial evaluating demcizumab in combination with ABRAXANE®
and gemcitabine in patients with first-line metastatic pancreatic
cancer. The trial did not meet its primary and secondary endpoints
of progression-free survival and overall survival, respectively.
Celgene retains an opt-in right on demcizumab.
- At the American Association for Cancer
Research (AACR) Annual Meeting in April, data presentations from
several collaboration partners highlighted the scientific
advancement of Celgene’s broad innovation strategy in
immuno-oncology:
- Jounce Therapeutics presented
preclinical data supporting the ongoing phase I/II ICONIC trial
evaluating JTX-2011, an agonist monoclonal antibody targeting
Inducible T cell CO-Stimulator (ICOS), as a single agent and in
combination with nivolumab in patients with advanced solid tumors.
The ICONIC trial is currently enrolling with preliminary efficacy
data expected in the second half of 2017.
- OncoMed Pharmaceuticals presented the
first public data of its anti-T cell immunoglobulin and ITIM domain
protein (TIGIT) antibody, OMP-313M32. The preclinical data
demonstrated immune activation and anti-tumor activity of
OMP-313M32 alone and in combination with checkpoint inhibitors.
OncoMed Pharmaceuticals plans to initiate a phase I trial in the
second quarter of 2017.
- At the American Society of Clinical
Oncology (ASCO) Annual Meeting in June, data presentations are
expected to include:
- Updated data from the phase III
MAGNIFY™ trial with REVLIMID® in combination with rituximab (R2) in
patients with relapsed and/or refractory indolent non-Hodgkin
lymphoma (NHL). The data analysis will focus on patients with
double-refractory or early relapsed follicular lymphoma (FL).
- Updated data from the phase I/II trial
evaluating IDHIFA® in patients with relapsed and/or refractory AML
with an IDH2 mutation. Data from this trial supports the NDA
currently under review by the FDA.
- Celgene’s collaboration partner
bluebird bio is expected to present updated data from the phase I
trial evaluating bb2121, a B-cell maturation antigen (BCMA)
chimeric antigen receptor (CAR)-T cell therapy, in patients with
RRMM. Celgene and bluebird bio plan to initiate a pivotal trial
with bb2121 in RRMM by year-end.
- Celgene’s collaboration partner Juno
Therapeutics is expected to present updated data from the phase I
TRANSCEND trial evaluating investigational CAR-T cell product
candidate, JCAR017, in patients with relapsed or refractory
aggressive NHL. Celgene and Juno Therapeutics plan to initiate a
pivotal trial with JCAR017 in NHL by year-end.
- At the 14th International Symposium on
Myelodysplastic Syndromes (MDS) in May, Celgene’s collaboration
partner Acceleron Pharma, Inc., is expected to present data from
the phase II trial evaluating luspatercept in first-line,
lower-risk MDS patients. Celgene plans to initiate a phase III
trial with luspatercept in first-line, lower-risk MDS in early
2018.
Inflammation & Immunology
- In February, Celgene disclosed positive
top-line results from the phase III SUNBEAM trial evaluating
ozanimod in patients with relapsing multiple sclerosis (RMS). The
trial met its primary endpoint in reducing annualized relapse rate
(ARR), compared to weekly interferon (IFN) β-1a (Avonex®). Data
from the confirmatory phase III RADIANCE trial are expected in the
second quarter. Celgene anticipates filing ozanimod for regulatory
approval by year-end based on these data.
- The phase II STEPSTONE trial evaluating
ozanimod in patients with moderate-to-severe Crohn’s disease is
complete. The data will be presented at a medical congress in the
second half of 2017. Based on these positive data, Celgene plans to
initiate a phase III trial with ozanimod in Crohn’s disease by
year-end.
- On March 1, 2017, OTEZLA® was launched
in Japan following full marketing authorization by Japan's Ministry
of Health, Labor and Welfare (MHLW) for the treatment of patients
with plaque psoriasis with an inadequate response to topical
therapies, as well as psoriatic arthritis.
- At the American Academy of Dermatology
(AAD) annual meeting, data were presented from the phase IV UNVEIL
trial evaluating OTEZLA® in patients with moderate plaque psoriasis
with a body surface area (BSA) of 5 to 10 percent who were naïve to
systemic and biologic therapy. At week 16, OTEZLA® demonstrated
significant improvements versus placebo for the primary endpoint
defined by the mean percentage change from baseline in the product
of Physician's Global Assessment and Body Surface Area (PGA×BSA).
The safety profile for OTEZLA® in the UNVEIL trial was consistent
with that of previous trials. Celgene is executing on a strategy to
maximize the value of OTEZLA® across additional patient segments in
psoriasis to include initiating a phase III trial in scalp
psoriasis in the second quarter of 2017.
- Data from the ongoing phase IIa trial
evaluating CC-220 in patients with systemic lupus erythematosus
(SLE) are expected to be presented at the European League Against
Rheumatism (EULAR) Annual Congress in June. Celgene plans to
initiate a phase IIb trial with CC-220 in the second half of
2017.
First Quarter 2017 Conference Call and Webcast
Information
Celgene will host a conference call to discuss the first quarter
of 2017 operational and financial performance on Thursday, April
27, 2017, 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 April 27, 2017, until midnight ET May 4, 2017.
To access the replay in the U.S., dial (855) 859-2056; outside the
U.S. dial (404) 537-3406. The participant passcode is 94675614.
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® as a single agent is also indicated as
a maintenance therapy in patients with multiple myeloma following
autologous hematopoietic stem cell transplant. REVLIMID® is
indicated for patients with transfusion-dependent anemia due to
low- or intermediate-1-risk myelodysplastic syndromes (MDS)
associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities. REVLIMID® is approved
in the U.S. for the treatment of patients with mantle cell lymphoma
(MCL) whose disease has relapsed or progressed after two prior
therapies, one of which included bortezomib. Limitations of Use:
REVLIMID® is not indicated and is not recommended for the treatment
of chronic lymphocytic leukemia (CLL) outside of controlled
clinical trials.
About ABRAXANE®
In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound)
is indicated for the treatment of metastatic breast cancer after
failure of combination chemotherapy for metastatic disease or
relapse within six months of adjuvant chemotherapy. Prior therapy
should have included an anthracycline unless clinically
contraindicated. ABRAXANE® is indicated for the first-line
treatment of locally advanced or metastatic non-small cell lung
cancer, in combination with carboplatin, in patients who are not
candidates for curative surgery or radiation therapy. ABRAXANE® is
also indicated for the first-line treatment of metastatic
adenocarcinoma of the pancreas in combination with gemcitabine.
About POMALYST®
In the U.S., POMALYST® (pomalidomide) is indicated for patients
with multiple myeloma who have received at least two prior
therapies including lenalidomide and a proteasome inhibitor and
have demonstrated disease progression on or within 60 days of
completion of the last therapy.
About OTEZLA®
In the U.S., OTEZLA® (apremilast) is indicated for the treatment
of adult patients with active psoriatic arthritis. OTEZLA® is
indicated in the U.S. for the treatment of patients with moderate
to severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
Forward-Looking Statement
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.
Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with
U.S. GAAP, this document also contains certain non-GAAP financial
measures based on management’s view of performance including:
- Adjusted research and development
expense
- Adjusted selling, general and
administrative expense
- Adjusted operating margin
- Adjusted net income
- Adjusted earnings per share
Management uses such measures internally for planning and
forecasting purposes and to measure the performance of the Company.
We believe these adjusted financial measures provide useful and
meaningful information to us and investors because they enhance
investors’ understanding of the continuing operating performance of
our business and facilitate the comparison of performance between
past and future periods. These adjusted financial measures are
non-GAAP measures and should be considered in addition to, but not
as a substitute for, the information prepared in accordance with
U.S. GAAP. When preparing these supplemental non-GAAP financial
measures we typically exclude certain GAAP items that management
does not consider to be normal, recurring, cash operating expenses
but that may not meet the definition of unusual or non-recurring
items. Other companies may define these measures in different ways.
The following categories of items are excluded from adjusted
financial results:
Acquisition and Divestiture-Related Costs: We exclude the impact
of certain amounts recorded in connection with business
combinations and divestitures from our adjusted financial results
that are either non-cash or not normal, recurring operating
expenses due to their nature, variability of amounts, and lack of
predictability as to occurrence and/or timing. These amounts may
include non-cash items such as the amortization of acquired
intangible assets, amortization of purchase accounting adjustments
to inventories, intangible asset impairment charges and expense or
income related to changes in the estimated fair value measurement
of contingent consideration. We also exclude transaction and
certain other cash costs associated with business acquisitions and
divestitures that are not normal recurring operating expenses,
including severance costs which are not part of a formal
restructuring program.
Share-based Compensation Expense: We exclude share-based
compensation from our adjusted financial results because
share-based compensation expense, which is non-cash, fluctuates
from period to period based on factors that are not within our
control, such as our stock price on the dates share-based grants
are issued.
Collaboration-related Upfront Expenses: We exclude
collaboration-related upfront expenses from our adjusted financial
results because we do not consider them to be normal, recurring
operating expenses due to their nature, variability of amounts, and
lack of predictability as to occurrence and/or timing. Upfront
payments to collaboration partners are made at the commencement of
a relationship anticipated to continue for a multi-year period and
provide us with intellectual property rights, option rights and
other rights with respect to particular programs. The variability
of amounts and lack of predictability of collaboration-related
upfront expenses makes the identification of trends in our ongoing
research and development activities more difficult. We believe the
presentation of adjusted research and development, which does not
include collaboration-related upfront expenses, provides useful and
meaningful information about our ongoing research and development
activities by enhancing investors’ understanding of our normal,
recurring operating research and development expenses and
facilitates comparisons between periods and with respect to
projected performance. All expenses incurred subsequent to the
initiation of the collaboration arrangement, such as research and
development cost-sharing expenses/reimbursements and milestone
payments up to the point of regulatory approval are considered to
be normal, recurring operating expenses and are included in our
adjusted financial results.
Research and Development Asset Acquisition Expense: We exclude
costs associated with acquiring rights to pre-commercial compounds
because we do not consider such costs to be normal, recurring
operating expenses due to their nature, variability of amounts, and
lack of predictability as to occurrence and/or timing. Research and
development asset acquisition expenses includes expenses to acquire
rights to pre-commercial compounds from a collaboration partner
when there will be no further participation from the collaboration
partner or other parties. The variability of amounts and lack of
predictability of research and development asset acquisition
expenses makes the identification of trends in our ongoing research
and development activities more difficult. We believe the
presentation of adjusted research and development, which does not
include research and development asset acquisition expenses,
provides useful and meaningful information about our ongoing
research and development activities by enhancing investors’
understanding of our normal, recurring operating research and
development expenses and facilitates comparisons between periods
and with respect to projected performance.
Restructuring Costs: We exclude costs associated with
restructuring initiatives from our adjusted financial results.
These costs include amounts associated with facilities to be
closed, employee separation costs and costs to move operations from
one location to another. We do not frequently undertake
restructuring initiatives and therefore do not consider such costs
to be normal, recurring operating expenses.
Certain Other Items: We exclude certain other significant items
that may occur occasionally and are not normal, recurring, cash
operating expenses from our adjusted financial results. Such items
are evaluated on an individual basis based on both the quantitative
and the qualitative aspect of their nature and generally represent
items that, either as a result of their nature or magnitude, we
would not anticipate occurring as part of our normal business on a
regular basis. While not all-inclusive, examples of certain other
significant items excluded from adjusted financial results would
be: expenses for significant fair value adjustments to equity
investments, significant litigation-related loss contingency
accruals and expenses to settle other disputed matters.
Estimated Tax Impact From Above Adjustments: We exclude the net
income tax impact of the non-tax adjustments described above from
our adjusted financial results. The net income tax impact of
the non-tax adjustments includes the impact on both current and
deferred income taxes and is based on the taxability of the
adjustment under local tax law and the statutory tax rate in the
tax jurisdiction where the adjustment was incurred.
Non-Operating Tax Adjustments: We exclude the net income tax
impact of certain other significant income tax items, which are not
associated with our normal, recurring operations (“Non-Operating
Tax Items”), from our adjusted financial
results. Non-Operating Tax Items include items which may occur
occasionally and are not normal, recurring operating expenses (or
benefits), including adjustments related to acquisitions,
divestitures, collaborations, certain adjustments to
the amount of unrecognized tax benefits related to prior year
tax positions, and other similar items. We also exclude excess tax
benefits and tax deficiencies that arise upon vesting or exercise
of share-based payments recognized as income tax benefits or
expenses due to their nature, variability of amounts, and lack of
predictability as to occurrence and/or timing.
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 periods ended March 31,
2017 and 2016, and for the projected amounts for the twelve-month
period ending December 31, 2017.
Celgene Corporation and Subsidiaries Condensed
Consolidated Statements of Income (Unaudited) (In
millions, except per share data)
Three-Month Periods Ended March 31, 2017 2016 Net product
sales $ 2,950 $ 2,495 Other revenue 10 17
Total revenue 2,960 2,512
Cost of goods sold (excluding amortization of acquired intangible
assets) 113 106 Research and development 995 733 Selling, general
and administrative 620 543 Amortization of acquired intangible
assets 82 92 Acquisition related charges and restructuring, net
39 36 Total costs and expenses
1,849 1,510 Operating income 1,111
1,002 Interest and investment income, net 15 7 Interest
(expense) (127 ) (122 ) Other income, net 26
35 Income before income taxes 1,025 922 Income
tax provision 84 121 Net income
$ 941 $ 801 Net income per common
share: Basic $ 1.21 $ 1.03 Diluted $ 1.16 $ 0.99 Weighted
average shares: Basic 779.0 780.6 Diluted 811.2 807.7
March 31, December 31, 2017 2016
Balance sheet items: Cash,
cash equivalents & marketable securities $ 8,861 $ 7,970 Total
assets 28,820 28,086 Long-term debt, including current portion
14,284 14,290 Total stockholders' equity 7,644 6,600
Celgene Corporation and Subsidiaries Reconciliation of
GAAP to Adjusted Net Income (In millions, except per share
data) Three-Month Periods Ended
March 31, 2017 2016 Net income - GAAP $ 941 $ 801
Before tax adjustments: Cost of goods sold (excluding amortization
of acquired intangible assets): Share-based compensation expense (1
) 7 9 Research and development: Share-based compensation
expense (1 ) 65 62 Collaboration-related upfront expense (2 ) 10 80
Research and development asset acquisition expense (3 ) 325 -
Selling, general and administrative: Share-based
compensation expense (1 ) 81 75 Amortization of acquired
intangible assets (4 ) 82 92 Acquisition related charges and
restructuring, net: Change in fair value of contingent
consideration (5 ) 39 33 Restructuring charges (6 ) - 3
Income tax provision: Estimated tax impact from above adjustments
(7 ) (111 ) (72 ) Non-operating tax adjustments (8 ) (75 )
(19 ) Net income - Adjusted $ 1,364 $ 1,064
Net income per common share - Adjusted Basic $ 1.75 $ 1.36
Diluted $ 1.68 $ 1.32 Explanation of adjustments: (1)
Exclude share-based compensation expense
totaling $153 for the three-month period ended March 31, 2017 and
$146 for the three-month period ended March 31, 2016.
(2) Exclude upfront payment expense for research and development
collaboration arrangements. (3) Exclude research and development
asset acquisition expenses. (4)
Exclude amortization of intangible assets
acquired in the acquisitions of Pharmion Corp., Gloucester
Pharmaceuticals, Inc. (Gloucester), Abraxis BioScience Inc.
(Abraxis), Celgene Avilomics Research, Inc. (Avila), and Quanticel
Pharmaceuticals, Inc. (Quanticel).
(5)
Exclude changes in the fair value of
contingent consideration related to the acquisitions of Gloucester,
Abraxis, Avila, Nogra Pharma Limited and Quanticel.
(6)
Exclude restructuring charges related to
our relocation of certain operations into our two Summit, NJ
locations as well as costs associated with certain headcount
reductions.
(7) Exclude the estimated tax impact of the above adjustments. (8)
Exclude other non-operating tax expense
items. The adjustment for the three-month period ended March 31,
2017 is to exclude the excess tax benefits of $75 related to the
adoption of ASU 2016-09 (Compensation-Stock Compensation). The
adjustment for the three-month period ended March 31, 2016 is to
exclude the tax benefit on the settlement of a state tax
examination of $8 and to include adjustments totaling tax expense
of $11.
Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2017 Projected GAAP to Adjusted Net
Income (In millions, except per share data)
Range Low High Projected
net income - GAAP (1) $ 4,851 $ 5,126 Before tax
adjustments: Cost of goods sold (excluding amortization of acquired
intangible assets): Share-based compensation expense 34 32
Research and development: Share-based compensation expense 266 251
Collaboration-related upfront expense 53 53 Research and
development asset acquisition expense 325 325 Selling,
general and administrative: Share-based compensation expense 336
316 Amortization of acquired intangible assets 333 326
Acquisition related charges and restructuring, net: Change
in fair value of contingent consideration 140 126 Income tax
provision: Estimated tax impact from above adjustments (436) (530)
Non-operating tax adjustments (75) (75) Projected net
income - Adjusted $ 5,827 $ 5,950 Projected net income per
diluted common share - GAAP $ 5.95 $ 6.29 Projected net
income per diluted common share - Adjusted $ 7.15 $ 7.30
Projected weighted average diluted shares 815.0 815.0 (1)
Our projected 2017 earnings do not include the effect of any
business combinations, collaboration agreements, asset
acquisitions, asset impairments, litigation-related loss
contingency accruals, changes in the fair value of our CVRs issued
as part of the acquisition of Abraxis or non-operating tax
adjustments that may occur after the day prior to the date of this
press release.
Celgene Corporation and
Subsidiaries Net Product Sales (In millions)
Three-Month Periods Ended March
31, % Change 2017 2016
Reported Operational(1)
Currency(2)
REVLIMID® U.S. $
1,234 $ 997 23.8% 23.8% 0.0% International 650 577
12.7% 14.3% (1.6)% Worldwide 1,884 1,574 19.7% 20.3% (0.6)%
POMALYST®/IMNOVID® U.S. 216 171 26.3%
26.3% 0.0% International 148 103 43.7% 45.5% (1.8)%
Worldwide 364 274 32.8% 33.5% (0.7)%
OTEZLA®
U.S. 199 175 13.7% 13.7% 0.0% International 43 21
104.8% 95.5% 9.3% Worldwide 242 196 23.5% 22.5% 1.0%
ABRAXANE® U.S. 142 144 (1.4)% (1.4)% 0.0%
International 94 81 16.0% 19.2% (3.2)% Worldwide 236
225 4.9% 6.1% (1.2)%
VIDAZA® U.S. 2 4 (50.0)%
(50.0)% 0.0% International 156 143 9.1% 10.9% (1.8)%
Worldwide 158 147 7.5% 9.2% (1.7)%
azacitidine for
injection U.S. 9 18 (50.0)% (50.0)% 0.0% International -
- N/A N/A N/A Worldwide 9 18 (50.0)% (50.0)% 0.0%
THALOMID® U.S. 22 27 (18.5)% (18.5)% 0.0%
International 14 14 0.0% 2.7% (2.7)% Worldwide 36 41
(12.2)% (11.3)% (0.9)%
ISTODAX® U.S. 17 16
6.3% 6.3% 0.0% International 3 2 50.0% 46.5% 3.5%
Worldwide 20 18 11.1% 10.8% 0.3%
All Other U.S. - 1
N/A N/A N/A International 1 1 N/A N/A N/A Worldwide 1
2 N/A N/A N/A
Total Net Product Sales U.S. 1,841
1,553 18.5% 18.5% 0.0% International 1,109 942 17.7%
19.2% (1.5)% Worldwide $ 2,950 $ 2,495 18.2% 18.8% (0.6)%
(1) Operational includes impact from both volume and price
(2) Currency includes the impact from both foreign exchange rates
and hedging activities
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170427005822/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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