— Total net product sales of $3,890 million,
increased 18% Y/Y
— Raising full-year total revenue guidance to
~$15.2 billion and OTEZLA® net product sales to ~$1.6 billion
— Showcasing our next-generation pipeline
across multiple disease areas at ASH
— Appointed Dr. Alise Reicin as President of
Global Clinical Development
Celgene Corporation (NASDAQ:CELG) reported net product sales of
$3,890 million for the third quarter of 2018, an 18 percent
increase from the same period in 2017. Celgene reported third
quarter 2018 total revenue of $3,892 million, an 18 percent
increase compared to $3,287 million in the third quarter of
2017.
Based on U.S. GAAP (Generally Accepted Accounting Principles),
Celgene reported net income of $1,082 million and diluted earnings
per share (EPS) of $1.50 for the third quarter of 2018. For the
third quarter of 2017, GAAP net income was $988 million and diluted
EPS was $1.21.
Adjusted net income for the third quarter of 2018 increased 6
percent to $1,645 million compared to $1,555 million in the third
quarter of 2017. For the same period, adjusted diluted EPS
increased 20 percent to $2.29 from $1.91.
“Excellent top- and bottom-line momentum in the third quarter
supports raising our 2018 financial guidance,” said Mark J. Alles,
Chairman and Chief Executive Officer of Celgene Corporation. “We
are focused on shaping Celgene’s future by rapidly advancing our
late-stage pipeline, accelerating promising early research
programs, and strengthening the organization.”
Third Quarter 2018 Financial
Highlights
Unless otherwise stated, all comparisons are for the third
quarter of 2018 compared to the third quarter of 2017. The adjusted
operating expense categories presented below exclude share-based
employee compensation expense and collaboration-related upfront
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 third quarter
increased 18 percent to $2,449 million. REVLIMID® sales growth was
driven by increases in market share and extended treatment
duration. U.S. sales of $1,667 million and international sales of
$782 million increased 22 percent and 9 percent year-over-year,
respectively.
- POMALYST®/IMNOVID® sales for the third
quarter were $513 million, an increase of 23 percent
year-over-year. POMALYST®/IMNOVID® sales growth was driven
primarily by increases in market share and treatment duration. U.S.
sales were $357 million and international sales were $156 million,
an increase of 33 percent and 5 percent year-over-year,
respectively.
- OTEZLA® sales for the third quarter
were $432 million, a 40 percent increase year-over-year. Third
quarter U.S. sales of $348 million and international sales of $84
million increased 39 percent and 45 percent year-over-year,
respectively. OTEZLA® sales growth in the U.S. was driven by
increases in demand with continued benefit from expanded market
access and higher channel inventory levels. OTEZLA® international
sales have maintained solid momentum in key ex-U.S. markets
including France and Japan.
- ABRAXANE® sales for the third quarter
were $288 million, a 15 percent increase year-over-year. ABRAXANE®
sales growth was driven by increases in demand and customer buying
patterns. U.S. sales were $174 million and international sales were
$114 million, an increase of 17 percent and 12 percent
year-over-year, respectively.
- In the third 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 $208 million compared to $226 million in the
third quarter of 2017.
Research and Development (R&D)
On a GAAP basis, R&D expenses were $1,081 million for the
third quarter of 2018 compared to $1,347 million for the same
period in 2017. Adjusted R&D expenses were $948 million for the
third quarter of 2018 compared to $698 million for the third
quarter of 2017. The current period included an increase in R&D
expense associated with the acquisition of Juno Therapeutics (Juno)
and regulatory submission-related work on multiple programs.
Additional R&D expenses (only included on a GAAP basis)
decreased in 2018, 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 $746 million for the
third quarter of 2018 compared to $608 million for the same period
in 2017. Adjusted SG&A expenses were $642 million for the third
quarter of 2018 compared to $521 million for the third quarter of
2017. The current period included an increase in SG&A expense
associated with the acquisition of Juno and marketing-related
expenses. Additional SG&A expense (only included on a GAAP
basis) increased in 2018, 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 $1.9 billion in the third quarter of
2018, compared to $1.1 billion for the third quarter of 2017. In
the third quarter, Celgene received approximately 6 million of its
shares upon final settlement of the accelerated share repurchase
(ASR) program, which commenced during the second quarter of 2018.
The total number of shares repurchased under the ASR agreement was
approximately 24.0 million at a weighted average price of $83.53
per share. Celgene ended the quarter with approximately $4.4
billion in cash, cash equivalents, marketable debt securities and
publicly-traded equity securities.
Celgene Expects
Volume-Driven Product Sales and Earnings Growth in
2018
Previous 2018 Guidance Updated 2018
Guidance Total Revenue ~$15.0B ~$15.2B REVLIMID® Net
Product Sales ~ $9.7B Unchanged POMALYST®/IMNOVID® Net Product
Sales ~ $2.0B Unchanged OTEZLA® Net Product Sales ~$1.5B ~$1.6B
ABRAXANE® Net Product Sales ~$1.0B Unchanged GAAP Operating Margin
~ 35% ~34% GAAP Diluted EPS $5.95-$6.25 $5.25-$5.75 Adjusted
Operating Margin ~56.0% ~55.5% Adjusted Diluted EPS $8.70-$8.75
$8.75-$8.80 Adjusted Tax Rate ~17% Unchanged Weighted Average
Diluted Shares ~735M Unchanged
Portfolio Updates
- At the 2018 American Society of
Hematology (ASH) annual meeting in December, expected data
presentations include:
- In collaboration with partner Acceleron
Pharma, data from the phase III MEDALIST™ and BELIEVE™ trials with
luspatercept in patients with low-to-intermediate risk
myelodysplastic syndromes (MDS) and transfusion-dependent
beta-thalassemia, respectively;
- Data from the phase I TRANSCEND CLL-004
trial evaluating liso-cel (JCAR017) in patients with relapsed
and/or refractory chronic lymphocytic leukemia (CLL);
- In collaboration with partner bluebird
bio, data from the phase I trial evaluating bb21217 in patients
with relapsed and/or refractory multiple myeloma (RRMM);
- Data from the phase I/II EVOLVE trial
evaluating JCARH125 in patients with RRMM; and,
- Data from the phase III AUGMENT™ trial
evaluating REVLIMID® in combination with rituximab (R²) in patients
with relapsed and/or refractory indolent non-Hodgkin lymphoma
(NHL).
- The phase III COMMANDS™ front-line
trial evaluating luspatercept in erythropoiesis-stimulating agent
(ESA)-naïve, very low, low or intermediate risk MDS patients
initiated in the third quarter.
- In collaboration with partner bluebird
bio, the clinical program evaluating bb2121 in earlier lines of
multiple myeloma is advancing, including the phase II MM-002 and
phase III MM-003 trials.
- In October, Celgene announced results
from a phase II/III cooperative group study (ECOG E3A06) conducted
by the National Cancer Institute in conjunction with the ECOG-ACRIN
Cancer Research Group. In the study, single-agent REVLIMID®
achieved a statistically significant improvement in the primary
endpoint of progression-free survival compared to observation in
patients with smoldering myeloma. Data from the ECOG E3A06 study
will be presented at a future medical meeting.
- At the European Society for Medical
Oncology (ESMO) 2018 congress in October, efficacy and safety data
were presented for the first time from the Genentech-sponsored
phase III IMpassion130 trial evaluating TECENTRIQ® (atezolizumab)
in combination with ABRAXANE® in patients with previously untreated
metastatic triple-negative breast cancer. These data were
simultaneously published in The New England Journal of Medicine. In
addition, data were presented from the Genentech-sponsored phase
III IMpower130 trial evaluating first-line treatment of TECENTRIQ®
plus chemotherapy (carboplatin and ABRAXANE®) in patients with
stage IV non-squamous non-small cell lung cancer (NSCLC).
- In October, Celgene announced that the
phase III STYLE™ trial evaluating OTEZLA® in patients with moderate
to severe plaque psoriasis of the scalp achieved a highly
statistically significant improvement in the primary endpoint of
the Scalp Physician’s Global Assessment (ScPGA) response at week 16
compared with placebo. In addition to achieving the primary
endpoint, statistical significance was also met for the secondary
endpoint of the whole-body itch numeric rating scale (NRS) at week
16 with OTEZLA® versus placebo. The safety profile for OTEZLA® in
the STYLE™ study was generally consistent with the known safety
profile of OTEZLA®, and no new safety signals were identified.
Additionally, the phase III ADVANCE™ trial evaluating OTEZLA® in
patients with mild to moderate plaque psoriasis is on track to
initiate by year-end 2018.
- In October, data from the phase II
HEROES™ trial evaluating RPC4046 in patients with eosinophilic
esophagitis (EoE) were presented at the United European
Gastroenterology Week (UEGW) conference. Data from the HEROES™
trial demonstrated that reductions in average esophageal eosinophil
count observed at week 16 in patients treated with RPC4046 (primary
endpoint) were sustained through an additional 52 weeks of
treatment in an open-label extension study.
Organizational Updates
- Celgene appointed Dr. Alise Reicin as
President, Global Clinical Development, effective November 1,
2018.
- Celgene appointed Aijaz “Jazz”
Tobaccowalla as Senior Vice President, Chief Digital &
Information Officer, effective August 27, 2018.
Third Quarter 2018 Conference Call and Webcast
Information
Celgene will host a conference call to discuss the third quarter
of 2018 operational and financial performance on Thursday, October
25, 2018, at 9 a.m. ET. The conference call will be available by
webcast at http://www.celgene.com. An audio replay of the call will
be available from noon October 25, 2018, until midnight ET November
1, 2018. To access the replay in the U.S., dial (855) 859-2056;
outside the U.S. dial (404) 537-3406. The participant passcode is
5516848.
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.
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 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.
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- and nine-month periods ended
September 30, 2018 and 2017, and for the projected amounts for the
twelve-month period ending December 31, 2018.
Celgene Corporation and Subsidiaries Condensed
Consolidated Statements of Operations (Unaudited) (In
millions, except per share data)
Three-Month Periods Ended Nine-Month Periods Ended September 30,
September 30, 2018 2017 2018
2017 Net product sales $ 3,890 $ 3,283
$ 11,229 $ 9,494 Other revenue 2 4
15 26 Total revenue 3,892
3,287 11,244 9,520
Cost of goods sold (excluding amortization of acquired intangible
assets) 157 118 418 342 Research and development 1,081 1,347 4,535
3,177 Selling, general and administrative 746 608 2,400 2,167
Amortization of acquired intangible assets 127 80 341 250
Acquisition related charges and restructuring, net 101
49 166 75 Total
costs and expenses 2,212 2,202
7,860 6,011 Operating income 1,680
1,085 3,384 3,509 Interest and investment income, net 8 33
30 72 Interest (expense) (193 ) (127 ) (551 ) (380 ) Other
(expense) income, net (117 ) - 852
(18 ) Income before income taxes 1,378 991
3,715 3,183 Income tax provision 296 3
742 162 Net income $
1,082 $ 988 $ 2,973 $ 3,021
Net income per common share: Basic $ 1.54 $ 1.26 $ 4.12 $
3.87 Diluted $ 1.50 $ 1.21 $ 4.02 $ 3.72 Weighted average
shares: Basic 702.0 784.1 722.0 781.2 Diluted 719.7 815.2 740.4
812.6 September 30, December 31, 2018
2017
Balance sheet items: Cash, cash
equivalents, debt securities available-for-sale and equity
investments with readily determinable fair values $ 4,378 $ 12,042
Total assets 34,215 30,141 Long-term debt, including current
portion 20,244 15,838 Total stockholders' equity 4,860 6,921
Celgene Corporation and Subsidiaries
Reconciliation of GAAP to Adjusted Net Income (In
millions, except per share data)
Three-Month Periods Ended Nine-Month Periods Ended September
30, September 30, 2018 2017 2018
2017 Net income - GAAP $ 1,082 $ 988 $
2,973 $ 3,021 Before tax adjustments: Cost of goods sold
(excluding amortization of acquired intangible assets): Share-based
compensation expense (1) 9 7 27 22 Research and development:
Share-based compensation expense (1) 125 65 481 200
Collaboration-related upfront expense (2) 8 584 399 669 Research
and development asset acquisition expense (3) - - 1,125 325
Adjustment to clinical trial and development activity wind-down
charge (4) - - (60 ) - Selling, general and administrative:
Share-based compensation expense (1) 104 87 415 260
Litigation-related loss contingency accrual expense (5) - - - 315
Amortization of acquired intangible assets (6) 127 80 341
250 Acquisition related charges and restructuring, net:
Change in fair value of contingent consideration and success
payments (7) 97 49 74 75 Acquisition related charges (8) 4 - 92 -
Other (expense) income, net: Change in fair value of equity
investments (9) 123 - (830 ) - Income tax provision:
Estimated tax impact from above adjustments (10) (57 ) (149 ) (242
) (387 ) Non-operating tax adjustments (11) 23
(156 ) 7 (326 ) Net income - Adjusted $ 1,645
$ 1,555 $ 4,802 $ 4,424 Net
income per common share - Adjusted Basic $ 2.34 $ 1.98 $ 6.65 $
5.66 Diluted $ 2.29 $ 1.91 $ 6.49 $ 5.44 Explanation of
adjustments: (1) Exclude share-based compensation expense
totaling $238 and $159 for the three-month periods ended September
30, 2018 and 2017, respectively. Exclude share-based compensation
expense totaling $923 and $482 for the nine-month periods ended
September 30, 2018 and 2017, 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 charge associated with the
discontinuance of GED-0301 clinical trials in Crohn’s disease. (5)
Exclude loss contingency accrual expenses related to a civil
litigation matter. (6)
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), Quanticel
Pharmaceuticals, Inc. (Quanticel) and Juno Therapeutics, Inc.
(Juno).
(7)
Exclude changes in the fair value of
contingent consideration related to the acquisitions of Gloucester,
Abraxis, Avila, Nogra Pharma Limited (Nogra), Quanticel and Juno,
as well as changes in the fair value of success payments related to
the acquisition of Juno.
(8) Exclude acquisition costs related to Juno. (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 period ended September
30, 2018 are to exclude the excess tax benefits related to the
adoption of ASU 2016-09 (Compensation-Stock Compensation) of $6,
adjustments to the provisional amounts recorded for the one-time
2017 U.S. Transition Tax of $36 and to exclude other adjustments
totaling tax benefit of $7. The adjustments for the nine-month
period ended September 30, 2018 are to exclude the excess tax
benefits related to the adoption of ASU 2016-09 (Compensation-Stock
Compensation) of $22, adjustments to the provisional amounts
recorded for the one-time 2017 U.S. Transition Tax of $36 and to
exclude other adjustments totaling tax benefit of $7.
The adjustments for the three-month period
ended September 30, 2017 are to exclude the excess tax benefits
related to the adoption of ASU 2016-09 (Compensation-Stock
Compensation) of $103, prior year tax benefits arising from a U.S.
research and development and orphan drug tax credits study of $55
and to exclude other adjustments totaling tax expense of $2. The
adjustments for the nine-month period ended September 30, 2017 are
to exclude the excess tax benefits related to the adoption of ASU
2016-09 (Compensation-Stock Compensation) of $273, prior year tax
benefits arising from a U.S. research and development and orphan
drug tax credits study of $55 and to exclude other adjustments
totaling tax expense of $2.
Celgene Corporation and Subsidiaries
Reconciliation of Full-Year 2018 Projected GAAP to Adjusted Net
Income (In millions, except per share data)
Range Low High Projected net income -
GAAP (1) $ 3,857 $ 4,228 Before tax
adjustments: Cost of goods sold (excluding amortization of acquired
intangible assets): Share-based compensation expense 33 27
Research and development: Share-based compensation expense 586 471
Collaboration-related upfront expense 399 399 Research and
development asset acquisition expense 1,125 1,125 Adjustment to
clinical trial and development activity wind-down charge (60 ) (60
) Selling, general and administrative: Share-based
compensation expense 573 461 Amortization of acquired
intangible assets 493 469 Acquisition related charges and
restructuring, net: Change in fair value of contingent
consideration and success payments 83 32 Acquisition related
charges 115 92 Other income (expense), net: Change in fair
value of equity investments (490 ) (490 ) Income tax
provision: Estimated tax impact from above adjustments (290 ) (293
) Non-operating tax adjustments 7
7 Projected net income - Adjusted $ 6,431
$ 6,468 Projected net income per
diluted common share - GAAP $ 5.25 $ 5.75 Projected net
income per diluted common share - Adjusted $ 8.75 $ 8.80
Projected weighted average diluted shares 735.0
735.0 (1) Our projected
2018 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.
Celgene
Corporation and Subsidiaries Net Product Sales (In
millions)
Three-Month Periods Ended September 30, %
Change 2018 2017 Reported
Operational(1)
Currency(2)
REVLIMID® U.S. $ 1,667 $ 1,361 22.5% 22.5% 0.0%
International 782 720 8.6% 10.2% (1.6)% Worldwide
2,449 2,081 17.7% 18.3% (0.6)%
POMALYST®/IMNOVID® U.S. 357 268 33.2%
33.2% 0.0% International 156 149 4.7% 6.1% (1.4)%
Worldwide 513 417 23.0% 23.5% (0.5)%
OTEZLA®
U.S. 348 250 39.2% 39.2% 0.0% International 84 58
44.8% 45.7% (0.9)% Worldwide 432 308 40.3% 40.5% (0.2)%
ABRAXANE® U.S. 174 149 16.8% 16.8% 0.0% International
114 102 11.8% 12.4% (0.6)% Worldwide 288 251 14.7%
14.9% (0.2)%
IDHIFA® (3) U.S. 18 7 157.1%
157.1% 0.0% International 1 - N/A N/A N/A Worldwide
19 7 171.4% 171.6% (0.2)%
VIDAZA® U.S. 2 1
100.0% 100.0% 0.0% International 137 150 (8.7)%
(7.2)% (1.5)% Worldwide 139 151 (7.9)% (6.4)% (1.5)%
azacitidine for injection U.S. 6 13 (53.8)% (53.8)% 0.0%
International 1 1 0.0% 9.1% (9.1)% Worldwide 7 14
(50.0)% (49.5)% (0.5)%
THALOMID® U.S. 19 21
(9.5)% (9.5)% 0.0% International 11 13 (15.4)%
(13.2)% (2.2)% Worldwide 30 34 (11.8)% (11.0)% (0.8)%
ISTODAX® U.S. 9 17 (47.1)% (47.1)% 0.0% International
4 2 100.0% 102.0% (2.0)% Worldwide 13 19 (31.6)%
(31.4)% (0.2)%
All Other U.S. - 1 N/A N/A N/A
International - - N/A N/A N/A Worldwide - 1 N/A N/A
N/A
Total Net Product Sales U.S. 2,600 2,088 24.5%
24.5% 0.0% International 1,290 1,195 7.9% 9.4% (1.5)%
Worldwide $ 3,890 $ 3,283 18.5% 19.0% (0.5)% (1)
Operational includes impact from both volume and price. (2)
Currency includes the impact from both foreign exchange rates and
hedging activities. (3)
IDHIFA® was approved in August 2017 in the
U.S. for the treatment of adult patients with R/R AML with an
isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA
approved test.
Celgene Corporation and
Subsidiaries Net Product Sales (In millions)
Nine-Month Periods Ended September 30, %
Change 2018 2017 Reported
Operational(1)
Currency(2)
REVLIMID® U.S. $ 4,740 $ 3,953 19.9% 19.9% 0.0%
International 2,396 2,046 17.1% 17.9% (0.8)%
Worldwide 7,136 5,999 19.0% 19.3% (0.3)%
POMALYST®/IMNOVID® U.S. 998 725 37.7%
37.7% 0.0% International 475 447 6.3% 7.2% (0.9)%
Worldwide 1,473 1,172 25.7% 26.1% (0.4)%
OTEZLA® U.S. 915 755 21.2% 21.2% 0.0% International
245 153 60.1% 60.6% (0.5)% Worldwide 1,160 908 27.8%
27.9% (0.1)%
ABRAXANE® U.S. 485 452 7.3% 7.3%
0.0% International 308 289 6.6% 7.2% (0.6)% Worldwide
793 741 7.0% 7.2% (0.2)%
IDHIFA® (3) U.S. 48 7
585.7% 585.7% 0.0% International 2 - N/A N/A N/A
Worldwide 50 7 614.3% 613.0% 1.3%
VIDAZA® U.S.
7 5 40.0% 40.0% 0.0% International 451 460 (2.0)%
(1.0)% (1.0)% Worldwide 458 465 (1.5)% (0.6)% (0.9)%
azacitidine for injection U.S. 17 31 (45.2)% (45.2)% 0.0%
International 2 1 100.0% 108.6% (8.6)% Worldwide 19
32 (40.6)% (40.4)% (0.2)%
THALOMID® U.S. 55 64
(14.1)% (14.1)% 0.0% International 34 40 (15.0)%
(13.8)% (1.2)% Worldwide 89 104 (14.4)% (14.0)% (0.4)%
ISTODAX® U.S. 39 51 (23.5)% (23.5)% 0.0%
International 10 7 42.9% 41.9% 1.0% Worldwide 49 58
(15.5)% (15.6)% 0.1%
All Other U.S. - 1 N/A N/A N/A
International 2 7 N/A N/A N/A Worldwide 2 8 N/A N/A
N/A
Total Net Product Sales U.S. 7,304 6,044 20.8%
20.8% 0.0% International 3,925 3,450 13.8% 14.8%
(1.0)% Worldwide $ 11,229 $ 9,494 18.3% 18.6% (0.3)% (1)
Operational includes impact from both volume and price. (2)
Currency includes the impact from both foreign exchange rates and
hedging activities. (3)
IDHIFA® was approved in August 2017 in the
U.S. for the treatment of adult patients with R/R AML with an
isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA
approved test.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181025005433/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