- Strong double-digit top- and bottom-line
growth across portfolio and geographies
- Reaffirming 2019 guidance and 2020 financial
targets
- Pipeline execution: fedratinib, ozanimod and
luspatercept regulatory applications submitted year-to-date
- Acquisition by Bristol-Myers Squibb approved
by shareholders; expected to close in the third quarter of 2019
Celgene Corporation (NASDAQ:CELG) reported net product sales of
$4,024 million for the first quarter of 2019, a 14 percent increase
from the same period in 2018. Celgene reported first quarter 2019
total revenue of $4,025 million, a 14 percent increase compared to
$3,538 million in the first quarter of 2018.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
Celgene reported net income of $1,545 million and diluted earnings
per share (EPS) of $2.14 for the first quarter of 2019. For the
first quarter of 2018, GAAP net income was $846 million and diluted
EPS was $1.10.
Adjusted net income for the first quarter of 2019 increased 17
percent to $1,834 million compared to $1,572 million in the first
quarter of 2018. For the same period, adjusted diluted EPS
increased 24 percent to $2.55 from $2.05.
“In the first quarter, we delivered strong top- and bottom-line
growth while advancing our innovative pipeline with multiple
regulatory submissions in the U.S. and EU,” said Mark J. Alles,
Chairman and Chief Executive Officer of Celgene Corporation. “Our
excellent operating performance continues to generate positive
momentum into the expected closing of the Bristol-Myers Squibb
transaction during the third quarter of 2019.”
First Quarter 2019 Financial
Highlights
Unless otherwise stated, all comparisons are for the first
quarter of 2019 compared to the first quarter of 2018. The adjusted
operating expense categories presented below exclude share-based
employee compensation expense, collaboration-related upfront
expense, research and development asset acquisition expense and a
benefit associated with the adjustment to clinical trial and
development activity wind-down costs. 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
were $2,577 million, an increase of 15 percent year-over-year. U.S.
sales of $1,686 million and international sales of $891 million
increased 13 percent and 19 percent year-over-year, respectively.
REVLIMID® sales growth was driven by increases in treatment
duration and market share
- POMALYST®/IMNOVID® sales for the first
quarter were $557 million, an increase of 23 percent
year-over-year. U.S. sales were $390 million and international
sales were $167 million, an increase of 30 percent and 9 percent
year-over-year, respectively. POMALYST®/IMNOVID® sales growth was
driven primarily by increases in treatment duration and market
share
- OTEZLA® sales for the first quarter
were $389 million, a 10 percent increase year-over-year. U.S. sales
of $301 million and international sales of $88 million increased 9
percent and 14 percent year-over-year, respectively. OTEZLA® sales
growth in the U.S. was driven by increases in demand, while
international sales were driven by continued expansion in key
ex-U.S. markets.
- ABRAXANE® sales for the first quarter
were $286 million, a 9 percent increase year-over-year. U.S. sales
were $196 million and international sales were $90 million, an
increase of 23 percent and a decrease of 13 percent year-over-year,
respectively. ABRAXANE® sales growth was driven primarily by
increases in demand and customer buying patterns.
- In the first quarter, all other product
sales, which include IDHIFA®, THALOMID®, ISTODAX®, VIDAZA® and an
authorized generic version of VIDAZA® drug product primarily sold
in the U.S., were $215 million compared to $229 million in the
first quarter of 2018.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $1,216 million for the
first quarter of 2019 compared to $2,203 million for the same
period in 2018. Adjusted R&D expenses were $874 million for the
first quarter of 2019 compared to $694 million for the first
quarter of 2018. The current period included an increase in R&D
expense associated with the acquisition of Juno Therapeutics and
regulatory submission-related work on multiple programs. Additional
R&D expenses (only included on a GAAP basis) decreased in 2019,
as outlined in the attached Reconciliation of GAAP to Adjusted Net
Income.
Selling, General and Administrative (SG&A)
On a GAAP basis, SG&A expenses were $773 million for the
first quarter of 2019 compared to $864 million for the same period
in 2018. Adjusted SG&A expenses were $654 million for the first
quarter of 2019 compared to $671 million for the first quarter of
2018. Additional SG&A expense (only included on a GAAP basis)
decreased in 2019, as outlined in the attached Reconciliation of
GAAP to Adjusted Net Income.
Cash, Cash Equivalents, Marketable Debt Securities and
Publicly-Traded Equity Securities
Operating cash flow was $1.5 billion in the first quarter of
2019, compared to $(325) million for the first quarter of 2018.
Celgene ended the quarter with approximately $7.7 billion in cash,
cash equivalents, marketable debt securities and publicly-traded
equity securities.
2019 Product Sales and Earnings
Guidance Reaffirmed
2019 Guidance
Year-over-Year Change Total Revenue $17.0B to
$17.2B ~12%
* REVLIMID® Net Product
Sales ~ $10.8B ~12% POMALYST®/IMNOVID® Net Product Sales ~ $2.4B
~18% OTEZLA® Net Product Sales ~ $1.9B ~18% ABRAXANE® Net Product
Sales ~ $1.1B ~4% GAAP Operating Margin** Approximately 49% N/M**
Adjusted Operating Margin Approximately 57.5% ~+200 bps Adjusted
Tax Rate ~17.0% ~+50 bps GAAP Diluted EPS $8.90 - $9.63
N/M
** Adjusted Diluted EPS $10.60 - $10.80 ~21%
*
Weighted average diluted shares ~715M ~(20M)
*Year-over-year percentage change based on the mid-point
of the range.**Not meaningful as the 2019 measures exclude
the impact of any strategic transactions, impairments, loss
contingencies, changes in the fair value of equity investments,
costs associated with the Bristol-Myers Squibb Company
(Bristol-Myers Squibb) and Celgene transaction and non-operating
tax adjustments that have not yet occurred.
Portfolio Updates
- At the upcoming 2019 American Society
of Clinical Oncology (ASCO) Annual Meeting, select oral data
presentations include:
- First clinical data from the phase I/II
trial evaluating CELMoD® agent iberdomide (CC-220) in patients with
relapsed and/or refractory multiple myeloma (RRMM);
- Updated data, including minimal
residual disease (MRD) response, from the phase I TRANSCEND CLL-004
trial evaluating liso-cel in patients with relapsed and/or
refractory chronic lymphocytic leukemia (CLL). Liso-cel recently
received Regenerative Medicine Advanced Therapy (RMAT) designation
in this setting. In addition, the Biologics License Application
(BLA) submission to the U.S. Food and Drug Administration (FDA) for
liso-cel in non-Hodgkin lymphoma (NHL) remains on-track for the
second half of 2019;
- Data from the phase III apact® trial
evaluating ABRAXANE® as adjuvant therapy in patients with
surgically resected pancreatic cancer. In March, Celgene announced
that the phase III apact® trial did not achieve the primary
endpoint of improvement in disease-free survival, compared to
gemcitabine alone. Overall survival, a secondary endpoint of the
study, was improved, reaching nominal statistical significance,
with ABRAXANE® in combination with gemcitabine compared to
gemcitabine alone. The safety profile observed in the apact® study
was consistent with previously reported studies of ABRAXANE®.
- Celgene today announced top-line
results from the phase III ROBUST trial evaluating REVLIMID® plus
rituximab, cyclophosphamide, doxorubicin, vincristine and
prednisone (R-CHOP) chemotherapy (R2-CHOP) in patients with
previously untreated activated B-cell (ABC) subtype diffuse large
B-cell lymphoma (DLBCL). The trial did not meet the primary
endpoint of demonstrating superiority in progression-free survival
(PFS) compared to placebo plus R-CHOP. The safety profile of
R2-CHOP was consistent with the known safety profiles of the
individual medicines, and no new safety signals were identified
with the combination.
- In April, Celgene and Acceleron Pharma
announced the submission of a BLA to the U.S. FDA for luspatercept,
an erythroid maturation agent, for the treatment of adult patients
with very low to intermediate risk myelodysplastic syndromes
(MDS)-associated anemia who have ring sideroblasts and require red
blood cell (RBC) transfusions and for the treatment of adult
patients with beta-thalassemia-associated anemia who require RBC
transfusions. In addition, Celgene plans to submit a marketing
application for both indications to the European Medicines Agency
(EMA) in April 2019.
- In March, Celgene announced that the
EMA Committee for Medicinal Products for Human Use (CHMP) adopted
positive opinions for REVLIMID® in combination with bortezomib and
dexamethasone (RVd) in adult patients with previously untreated
multiple myeloma who are not eligible for transplant and for
POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone
(PVd) for the treatment of adult patients with multiple myeloma who
have received at least one prior treatment regimen including
REVLIMID®.
- In March, Celgene announced the
submission of a New Drug Application (NDA) to the U.S. FDA for
ozanimod in patients with relapsing forms of multiple sclerosis
(RMS) and the submission of a Marketing Authorization Application
(MAA) to the EMA for ozanimod in relapsing-remitting multiple
sclerosis (RRMS). In addition, the phase III TRUE NORTH trial
evaluating ozanimod in patients with ulcerative colitis (UC)
completed enrollment in April.
- In March, Celgene announced that the
U.S. FDA granted Priority Review designation for the NDA for
fedratinib in patients with myelofibrosis. The Prescription Drug
User Fee Act (PDUFA) date for the submission is September 3, 2019.
The EU MAA submission is now planned by year-end 2019.
- In March, Roche announced the
accelerated approval of TECENTRIQ® (atezolizumab) in combination
with ABRAXANE® for the treatment of adult patients with
unresectable locally advanced or metastatic triple-negative breast
cancer (TNBC) whose tumors express PD-L1 as determined by an FDA
approved test. This accelerated approval is based on results from
the phase III IMpassion130 study.
- In February, Celgene announced that the
FDA granted Priority Review designation for the supplemental New
Drug Application (sNDA) for REVLIMID® in combination with rituximab
(R²) in patients with relapsed and/or refractory indolent NHL. The
PDUFA date for the submission is June 27, 2019.
Business Updates
- On April 12, 2019, the stockholders of
Celgene voted to adopt the proposed merger and the stockholders of
Bristol-Myers Squibb voted to approve the issuance of shares of
Bristol-Myers Squibb common stock in connection with the proposed
merger. The parties continue to expect the transaction to close in
the third quarter of 2019, subject to customary closing conditions
and regulatory approvals.
First Quarter 2019 Earnings Information
Due to the pending transaction with Bristol-Myers Squibb,
Celgene is not hosting a conference call in conjunction with its
first-quarter 2019 earnings release and does not expect to do so
for future quarters. Please direct any questions regarding this
press release to Celgene Investor Relations or Celgene
Communications.
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.
TECENTRIQ® is a registered trademark of Genentech, a member of
the Roche Group.
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, including factors related to the proposed
transaction between Bristol-Myers Squibb and Celgene, such as, but
not limited to, the risks that: management’s time and attention is
diverted on transaction related issues; disruption from the
transaction makes it more difficult to maintain business,
contractual and operational relationships; legal proceedings are
instituted against Bristol-Myers Squibb, Celgene or the combined
company; and Bristol-Myers Squibb, Celgene or the combined company
is unable to retain key personnel.
Hyperlinks are provided as a convenience and for informational
purposes only. Celgene bears no responsibility for the security or
content of external websites.
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/Integration 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 and success payments. 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 as well as integration preparation
costs associated with our merger with Bristol-Myers Squibb.
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: significant litigation-related loss contingency accruals and
expenses to settle other disputed matters and, effective for fiscal
year 2018, changes in the fair value of our equity securities upon
the adoption of ASU 2016-01 (Financial Instruments-Overall:
Recognition and Measurement of Financial Assets and Financial
Liabilities).
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, the impact of tax reform legislation commonly
referred to as the Tax Cuts and Jobs Act (2017 Tax Act), 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,
2019 and 2018, and for the projected amounts for the twelve-month
period ending December 31, 2019.
Celgene Corporation and Subsidiaries Condensed
Consolidated Statements of Operations (Unaudited) (In
millions, except per share data) Three-Month
Periods Ended March 31, 2019 2018 Net product sales $
4,024 $ 3,531 Other revenue 1 7 Total
revenue 4,025 3,538 Cost of
goods sold (excluding amortization of acquired intangible assets)
140 135 Research and development 1,216 2,203 Selling, general and
administrative 773 864 Amortization of acquired intangible assets
109 87 Acquisition/integration related charges and restructuring,
net 77 31 Total costs and expenses
2,315 3,320 Operating income
1,710 218 Interest and investment income, net 34 13 Interest
(expense) (192 ) (166 ) Other income, net 262
965 Income before income taxes 1,814 1,030
Income tax provision 269 184 Net
income $ 1,545 $ 846 Net income per
common share: Basic $ 2.20 $ 1.13 Diluted $ 2.14 $ 1.10
Weighted average shares: Basic 702.4 748.3 Diluted 720.5 768.3
March 31, December 31, 2019 2018
Balance sheet
items:
Cash, cash equivalents, debt securities
available-for-sale and equity investments with readily determinable
fair values
$ 7,691 $ 6,042 Total assets 37,639 35,480 Long-term debt,
including current portion 20,281 20,270 Total stockholders' equity
8,165 6,161
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Adjusted Net Income (In
millions, except per share data)
Three-Month Periods Ended March 31, 2019 2018 Net
income - GAAP $ 1,545 $ 846 Before tax adjustments: Cost of
goods sold (excluding amortization of acquired intangible assets):
Share-based compensation expense (1) 12 9 Research and
development: Share-based compensation expense (1) 126 199
Collaboration-related upfront expense (2) 216 245 Research and
development asset acquisition expense (3) - 1,125 Adjustment
related to clinical trial and development activity wind-down costs
(4) - (60 ) Selling, general and administrative: Share-based
compensation expense (1) 119 193 Amortization of acquired
intangible assets (5) 109 87 Acquisition/integration related
(gains) charges and restructuring, net: Change in fair value of
contingent consideration and success payments (6) 30 (30 ) Juno
acquisition related charges (7) - 61 Bristol-Myers Squibb
acquisition/integration related charges (8) 47 - Other
(expense) income, net: Change in fair value of equity investments
(9) (269 ) (959 ) Income tax provision: Estimated tax impact
from above adjustments (10) (85 ) (133 ) Non-operating tax
adjustments (11) (16 ) (11 ) Net income - Adjusted $
1,834 $ 1,572 Net income per common share -
Adjusted Basic $ 2.61 $ 2.10 Diluted $ 2.55 $ 2.05 Explanation of
adjustments: (1) Exclude share-based compensation expense
totaling $257 and $401 for the three-month periods ended March 31,
2019 and 2018, respectively. (2) Exclude upfront payment expense
for research and development collaboration arrangements. (3)
Exclude research and development asset acquisition expenses. (4)
Exclude adjustment of clinical trial and
development activity wind-down costs associated with the
discontinuance of GED-0301 clinical trials in Crohn's disease.
(5)
Exclude amortization of intangible assets
acquired in the acquisitions of Pharmion Corp., Gloucester
Pharmaceuticals, Inc. (Gloucester), Abraxis BioScience, Inc.
(Abraxis), Quanticel Pharmaceuticals, Inc. (Quanticel) and Juno
Therapeutics, Inc. (Juno).
(6)
Exclude changes in the fair value of
contingent consideration related to the acquisitions of Gloucester,
Abraxis, Celgene Avilomics Research, Inc., Quanticel and Juno
(including success payments).
(7) Exclude acquisition costs related to the Juno acquisition. (8)
Exclude acquisition and integration preparation costs related to
the pending Bristol-Myers Squibb merger. (9)
Exclude changes in the fair value of
equity investments upon the adoption of ASU 2016-01 (Financial
Instruments-Overall: Recognition and Measurement of Financial
Assets and Financial Liabilities).
(10) Exclude the estimated tax impact of the above adjustments.
(11)
Exclude other non-operating tax expense
items. The adjustments for the three-month periods ended March 31,
2019 and 2018 are to exclude excess tax benefits of $16 and $11,
respectively, recorded in the Income Tax Provision as per ASU
2016-09 (Compensation-Stock Compensation).
Celgene Corporation and Subsidiaries Reconciliation of
Full-Year 2019 Projected GAAP to Adjusted Net Income (In
millions, except per share data) Range Low
High Projected net income - GAAP (1) $ 6,361 $
6,883 Before tax adjustments: Cost of goods sold
(excluding amortization of acquired intangible assets): Share-based
compensation expense 26 23 Research and development:
Share-based compensation expense 424 362 Collaboration-related
upfront expense 216 216 Selling, general and administrative:
Share-based compensation expense 371 317 Amortization of
acquired intangible assets 459 424 Acquisition/integration
related charges and restructuring, net: Change in fair value of
contingent consideration and success payments 33 - Bristol-Myers
Squibb acquisition/integration related charges 50 50 Other
(expense) income, net: Change in fair value of equity investments
(111 ) (111 ) Income tax provision: Estimated tax impact
from above adjustments (234 ) (426 ) Non-operating tax adjustments
(16 ) (16 ) Projected net income -
Adjusted $ 7,579 $ 7,722
Projected net income per diluted common share - GAAP $ 8.90 $ 9.63
Projected net income per diluted common share - Adjusted $
10.60 $ 10.80 Projected weighted average diluted shares
715.0 715.0 (1)
Our projected 2019 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, changes in the fair value of
equity investments upon the adoption of ASU 2016-01 (Financial
Instruments-Overall: Recognition and Measurement of Financial
Assets and Financial Liabilities) or non-operating tax adjustments
that may occur after the day prior to the date of this press
release. In addition, our projected 2019 financial measures do not
include the effect of costs associated with the Bristol-Myers
Squibb and Celgene transaction 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
2019
2018
Reported Operational(1)
Currency(2)
REVLIMID® U.S. $ 1,686 $
1,487 13.4 % 13.4 % 0.0 % International 891
747 19.3 % 22.6 % (3.3 )% Worldwide 2,577 2,234 15.4 % 16.5
% (1.1 )%
POMALYST®/IMNOVID®
U.S. 390 300 30.0 % 30.0 % 0.0 % International 167
153 9.2 % 11.2 % (2.0 )% Worldwide 557 453 23.0 %
23.7 % (0.7 )%
OTEZLA® U.S. 301 276 9.1 % 9.1
% 0.0 % International 88 77 14.3 % 15.1
% (0.8 )% Worldwide 389 353 10.2 % 10.4 % (0.2 )%
ABRAXANE® U.S. 196 159 23.3 % 23.3 % 0.0 %
International 90 103 (12.6 )% (11.7 )%
(0.9 )% Worldwide 286 262 9.2 % 9.5 % (0.3 )%
IDHIFA® U.S. 19 14 35.7 % 35.7 % 0.0 % International
3 - N/A N/A N/A Worldwide 22 14 57.1 %
58.1 % (1.0 )%
VIDAZA® U.S. 3 2 50.0 % 50.0 %
0.0 % International 148 155 (4.5 )%
(2.2 )% (2.3 )% Worldwide 151 157 (3.8 )% (1.6 )% (2.2 )%
azacitidine for injection U.S. 5 6 (16.7 )% (16.7 )% 0.0 %
International 2 1 100.0 % 99.3 % 0.7 %
Worldwide 7 7 0.0 % (0.1 )% 0.1 %
THALOMID®
U.S. 15 19 (21.1 )% (21.1 )% 0.0 % International 9
12 (25.0 )% (22.1 )% (2.9 )% Worldwide 24 31 (22.6 )%
(21.5 )% (1.1 )%
ISTODAX® U.S. 6 16 (62.5 )%
(62.5 )% 0.0 % International 4 3 33.3 %
33.7 % (0.4 )% Worldwide 10 19 (47.4 )% (47.3 )% (0.1 )%
All Other U.S. - - N/A N/A N/A International 1
1 N/A N/A N/A Worldwide 1 1 N/A N/A N/A
Total Net Product Sales U.S. 2,621 2,279 15.0 % 15.0 % 0.0 %
International 1,403 1,252 12.1 % 14.8 %
(2.7 )% Worldwide $ 4,024 $ 3,531 14.0 % 14.9 % (0.9
)%
(1) Operational includes the impact from both fluctuations in
volume and net selling price changes.(2) Currency includes the
impact from both fluctuations in foreign exchange rates and hedging
activities.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190425005885/en/
CelgeneInvestors:908-673-9628ir@celgene.comorMedia:908-673-2275media@celgene.com
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celgene (NASDAQ:CELG)
Historical Stock Chart
From Apr 2023 to Apr 2024