-
Increases Fourth Quarter Revenues 10% to $6.0 Billion, 9% for Full
Year to $22.6 Billion
-
Posts Fourth Quarter GAAP EPS of $0.73 and Non-GAAP EPS of $0.94
-
Announces Strategic Acquisition of Celgene Corporation
-
Announces Voluntary Withdrawal of U.S. Application for Opdivo Plus
Low-Dose Yervoy for Treatment of First-Line Lung Cancer in Patients
with Tumor Mutational Burden ≥10 Mutations/Megabase, following
discussions with the U.S. FDA
-
Additional OpdivoPlus Yervoy Approvals in Europe for
Patients with Renal Cell Carcinoma
-
Provides full-line item guidance with 2019 GAAP EPS Guidance Range
of $3.75 to $3.85 and Non-GAAP EPS Guidance Range of $4.10 to $4.20
NEW YORK--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) today reported results for the fourth
quarter and full year of 2018 which were highlighted by strong demand
for Opdivo
(nivolumab) and Eliquis(apixaban) and a robust operating performance across the portfolio.
“I am proud of our results in 2018, which were based on superior
commercial performance for our prioritized brands and important
scientific advances that continue to diversify our R&D pipeline. We are
beginning 2019 with good momentum in our current business, with Opdivo
and Eliquis continuing as strong and growing franchises,” said Giovanni
Caforio, M.D., chairman and chief executive officer, Bristol-Myers
Squibb. “Our planned acquisition of Celgene will position us to create a
leading biopharma company, with best-in-class franchises, significant
near-term launch opportunities and a deep and broad pipeline, creating
an even stronger foundation for long-term sustainable growth.”
|
|
|
|
|
Fourth Quarter
|
$ amounts in millions, except per share amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018
|
|
|
2017
|
|
|
Change
|
Total Revenues
|
|
|
|
$5,973
|
|
|
$5,449
|
|
|
10%
|
GAAP Diluted EPS
|
|
|
|
0.73
|
|
|
(1.42)
|
|
|
**
|
Non-GAAP Diluted EPS
|
|
|
|
0.94
|
|
|
0.68
|
|
|
38%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Full Year
|
$ amounts in millions, except per share amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018
|
|
|
2017
|
|
|
Change
|
Total Revenues
|
|
|
|
$22,561
|
|
|
$20,776
|
|
|
9%
|
GAAP Diluted EPS
|
|
|
|
3.03
|
|
|
0.61
|
|
|
**
|
Non-GAAP Diluted EPS
|
|
|
|
3.98
|
|
|
3.01
|
|
|
32%
|
|
**In excess of +/- 100%
|
|
FOURTH QUARTER FINANCIAL RESULTS
-
Bristol-Myers Squibb posted fourth quarter 2018 revenues of $6.0
billion, an increase of 10% compared to the same period a year ago.
Revenues increased 12% when adjusted for foreign exchange impact.
-
U.S. revenues increased 16% to $3.3 billion in the quarter compared to
the same period a year ago. International revenues increased 3%. When
adjusted for foreign exchange impact, international revenues increased
7%.
-
Gross margin as a percentage of revenue increased from 69.2% to 71.7%
in the quarter primarily due to higher inventory write-offs and
startup charges in the fourth quarter last year.
-
Marketing, selling and administrative expenses increased 2% to $1.3
billion in the quarter.
-
Research and development expenses decreased 29% to $1.4 billion in the
quarter primarily due to license and asset acquisition charges of $377
million in the fourth quarter last year.
-
The effective tax rate was 23.1% in the quarter, compared to 433.7% in
the fourth quarter last year. The tax rate in the fourth quarter last
year was impacted by a one-time $2.9 billion charge resulting from
U.S. tax reform.
-
The company reported net earnings attributable to Bristol-Myers Squibb
of $1.2 billion, or $0.73 per share, in the fourth quarter, compared
to a net loss of $2.3 billion, or $1.42 per share, for the same period
in 2017. The results in the fourth quarter last year included the
transitional impact of U.S. tax reform.
-
The company reported non-GAAP net earnings attributable to
Bristol-Myers Squibb of $1.5 billion, or $0.94 per share, in the
fourth quarter, compared to net earnings of $1.1 billion, or $0.68 per
share, for the same period in 2017. An overview of specified items is
discussed under the “Use of Non-GAAP Financial Information” section.
-
Cash, cash equivalents and marketable securities were $10.7 billion,
with a net cash position of $3.3 billion, as of December 31, 2018.
ACQUISITION OF CELGENE CORPORATION
-
In January, the company and Celgene Corporation announced they have
entered into a definitive merger agreement under which the company
will acquire Celgene. (link)
FOURTH QUARTER PRODUCT AND PIPELINE UPDATE
Product Sales/Business Highlights
Global revenues for the fourth quarter of 2018, compared to the fourth
quarter of 2017, were driven by:
-
Opdivo
,
which grew by $443 million or a 33% increase
-
Eliquis
,
which grew by $342 million or a 25% increase
-
Yervoy
,
which grew by $115 million or a 43% increase
-
Orencia
,
which grew by 10%
-
Sprycel
,
which grew by 2%
Opdivo
Regulatory
-
Following recent discussions with the U.S. Food and Drug
Administration (FDA), the company today announced the voluntary
withdrawal of the U.S. supplemental Biologics License Application
(sBLA) for the Opdivo and low-dose Yervoy (ipilimumab)
combination for treatment of first-line advanced non-small cell lung
cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10
mutations/megabase (mut/Mb).
In October 2018, the company
announced the submission of an exploratory overall survival (OS)
analysis for the TMB <10 mut/Mb subgroup to the FDA. The FDA
determined at that time, that the submission of this new information
constituted a major amendment to the sBLA and extended the review
period by three months, moving the Prescription Drug User Fee Act date
to May 20, 2019.
After recent discussions with the FDA, the
company believes further evidence on the relationship between TMB and
PD-L1 is required to fully evaluate the impact of Opdivo plus Yervoy
on OS in first-line NSCLC patients. This analysis will require
availability of the final data from Checkmate -227, Part 1a (Opdivo
plus low-dose Yervoy or Opdivo monotherapy versus
chemotherapy in patients whose tumors express PD-L1), which the
company anticipates will be available in the first-half of 2019. Since
these data from Checkmate -227, Part 1a, will not be available within
the review cycle of the current application the company decided to
withdraw.
-
In January, the company announced the European Commission approved the
combination of Opdivo plus Yervoy for the first-line
treatment of patients with intermediate- and poor-risk advanced renal
cell carcinoma.
Clinical
-
In November, the company announced top-line results from
the Phase 3 CheckMate -451 trial in patients with extensive-stage
small cell lung cancer without disease progression after completion of
first-line platinum-based chemotherapy treatment with Opdivo
plus Yervoy versus placebo. (link)
Eliquis
Clinical
-
In November, at the American Heart Association Scientific Sessions
2018, the company-Pfizer alliance presented new real-world evidence
from a sub-analysis of the ARISTOPHANES study comparing the safety and
effectiveness of non-vitamin K antagonist oral anticoagulants,
including Eliquis, in non-valvular atrial fibrillation patient
populations aged 80 and older. (link)
Sprycel
Regulatory
-
In January, the company announced the U.S. Food and Drug
Administration (FDA) expanded the indication for Sprycel
(dasatinib) tablets to include the treatment of pediatric patients one
year of age or older with newly diagnosed Philadelphia
chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in
combination with chemotherapy.
-
In December, the company announced the Committee for Medicinal
Products for Human Use of the European Medicines Agency recommended
the expanded approval of Sprycel, in combination with
chemotherapy, to include the treatment of pediatric patients with
newly diagnosed Ph+ ALL.
Empliciti
Regulatory
-
In November, the company announced the FDA approved Empliciti(elotuzumab) in combination with pomalidomide and dexamethasone
for the treatment of adult patients with multiple myeloma who have
received at least two prior therapies, including lenalidomide and a
proteasome inhibitor.
FOURTH QUARTER BUSINESS DEVELOPMENT UPDATE
-
In December, the company announced Taisho Pharmaceutical Holdings Co.,
Ltd. offered to purchase the company’s UPSA consumer health business
for $1.6 billion.
-
In December, the company and Boston Medical Center announced a
multi-year joint research study to identify and analyze potential
sensitivity and resistance markers in patients treated with
standard-of-care checkpoint inhibitors.
-
In December, the company, Eisai Co., Ltd. and its U.S.-based precision
medicine research & development subsidiary H3 Biomedicine, Inc.
announced a multi-year research collaboration to explore modulating
RNA splicing to develop potential first-in-class therapies that would
direct the immune system to target cancer cells and help more patients
experience the benefits of immunotherapy.
-
In December, the company and Vedanta Biosciences announced a clinical
trial collaboration to evaluate Opdivo in combination with
Vedanta Biosciences’ VE800 in patients with advanced or metastatic
cancers.
-
In November, the company and Infinity Pharmaceuticals, Inc. announced
a clinical trial collaboration to evaluate Opdivo in
combination with Infinity’s IPI-549 in patients with advanced
urothelial cancer.
2019 FINANCIAL GUIDANCE
Bristol-Myers Squibb is confirming its 2019 GAAP EPS guidance range of
$3.75 - $3.85 and its non-GAAP EPS guidance range of $4.10 - $4.20. Both
GAAP and non-GAAP guidance assume current exchange rates. Key 2019 GAAP
and non-GAAP line-item guidance assumptions are:
-
Worldwide revenues increasing in the mid-single digits.
-
Gross margin as a percentage of revenue to be approximately 70% to 71%
for both GAAP and non-GAAP.
-
Marketing, selling and administrative expenses decreasing in the
mid-single digit range for both GAAP and non-GAAP.
-
Research and development expenses decreasing in the mid-single digits
for GAAP and increasing in the high-single digits for non-GAAP.
-
An effective tax rate of approximately 15% for GAAP and approximately
17% for non-GAAP.
The financial guidance for 2019 excludes the impact of any potential
future strategic acquisitions and divestitures, including any impact of
the Celgene acquisition, and any specified items that have not yet been
identified and quantified. The non-GAAP 2019 guidance also excludes
other specified items as discussed under “Use of Non-GAAP Financial
Information.” Details reconciling adjusted non-GAAP amounts with the
amounts reflecting specified items are provided in supplemental
materials available on the company’s website.
Use of Non-GAAP Financial Information
This press release contains non-GAAP financial measures, including
non-GAAP earnings and related EPS information, that are adjusted to
exclude certain costs, expenses, gains and losses and other specified
items that are evaluated on an individual basis. These items are
adjusted after considering their quantitative and qualitative aspects
and typically have one or more of the following characteristics, such as
being highly variable, difficult to project, unusual in nature,
significant to the results of a particular period or not indicative of
future operating results. Similar charges or gains were recognized in
prior periods and will likely reoccur in future periods, including
restructuring costs, accelerated depreciation and impairment of
property, plant and equipment and intangible assets, R&D charges in
connection with the acquisition or licensing of third party intellectual
property rights, divestiture and equity investment gains or losses,
upfront payments from out-licensed assets, pension charges, legal and
other contractual settlements and debt redemption gains or losses, among
other items. Deferred and current income taxes attributed to these items
are also adjusted for considering their individual impact to the overall
tax expense, deductibility and jurisdictional tax rates. Non-GAAP
information is intended to portray the results of our baseline
performance, supplement or enhance management, analysts and investors
overall understanding of our underlying financial performance and
facilitate comparisons among current, past and future periods. For
example, non-GAAP earnings and EPS information is an indication of our
baseline performance before items that are considered by us to not be
reflective of our ongoing results. In addition, this information is
among the primary indicators that we use as a basis for evaluating
performance, allocating resources, setting incentive compensation
targets and planning and forecasting for future periods. This
information is not intended to be considered in isolation or as a
substitute for net earnings or diluted EPS prepared in accordance with
GAAP and may not be the same as or comparable to similarly titled
measures presented by other companies due to possible differences in
method and in the items being adjusted.
Company and Conference Call Information
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit us at BMS.com
or follow us on LinkedIn,
Twitter,
YouTube
and Facebook.
There will be a conference call on January 24, 2019 at 8:30 a.m. ET
during which company executives will review financial information and
address inquiries from investors and analysts. Investors and the general
public are invited to listen to a live webcast of the call at http://investor.bms.com
or by calling the U.S. toll free 800-458-4121 or international
786-789-4772, confirmation code: 9368504. Materials related to the call
will be available at the same website prior to the conference call. A
replay of the call will be available beginning at 11:45 a.m. ET on
January 24, 2019 through 11:45 a.m. ET on February 7, 2019. The replay
will also be available through http://investor.bms.com
or by calling the U.S. toll free 888-203-1112 or international
719-457-0820, confirmation code: 9368504.
Website Information
We routinely post important information for investors on our website,
BMS.com, in the “Investors” section. We may use this website as a means
of disclosing material, non-public information and for complying with
our disclosure obligations under Regulation FD. Accordingly, investors
should monitor the Investors section of our website, in addition to
following our press releases, SEC filings, public conference calls,
presentations and webcasts. We may also use social media channels to
communicate with our investors and the public about our company, our
products and other matters, and those communications could be deemed to
be material information. The information contained on, or that may be
accessed through, our website or social media channels are not
incorporated by reference into, and are not a part of, this document.
Important Information for Investors and
Stockholders
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of any
vote or approval. It does not constitute a prospectus or prospectus
equivalent document. No offering of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the U.S.
Securities Act of 1933, as amended.
In connection with the proposed transaction between Bristol-Myers Squibb
Company (“Bristol-Myers Squibb”) and Celgene Corporation (“Celgene”),
Bristol-Myers Squibb and Celgene will file relevant materials with the
Securities and Exchange Commission (the “SEC”), including a
Bristol-Myers Squibb registration statement on Form S-4 that will
include a joint proxy statement of Bristol-Myers Squibb and Celgene that
also constitutes a prospectus of Bristol-Myers Squibb, and a definitive
joint proxy statement/prospectus will be mailed to stockholders of
Bristol-Myers Squibb and Celgene. INVESTORS AND SECURITY HOLDERS OF
BRISTOL-MYERS SQUIBB AND CELGENE ARE URGED TO READ THE JOINT PROXY
STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC
CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will
be able to obtain free copies of the registration statement and the
joint proxy statement/prospectus (when available) and other documents
filed with the SEC by Bristol-Myers Squibb or Celgene through the
website maintained by the SEC at http://www.sec.gov.
Copies of the documents filed with the SEC by Bristol-Myers Squibb will
be available free of charge on Bristol-Myers Squibb’s internet website
at http://www.bms.com
under the tab, “Investors” and under the heading “Financial Reporting”
and subheading “SEC Filings” or by contacting Bristol-Myers Squibb’s
Investor Relations Department through https://www.bms.com/investors/investor-contacts.html.
Copies of the documents filed with the SEC by Celgene will be available
free of charge on Celgene’s internet website at http://www.celgene.com
under the tab “Investors” and under the heading “Financial Information”
and subheading “SEC Filings” or by contacting Celgene’s Investor
Relations Department at ir@celgene.com.
Certain Information Regarding Participants
Bristol-Myers Squibb, Celgene, and their respective directors and
executive officers may be considered participants in the solicitation of
proxies in connection with the proposed acquisition of Celgene.
Information about the directors and executive officers of Bristol-Myers
Squibb is set forth in its Annual Report on Form 10-K for the year ended
December 31, 2017, which was filed with the SEC on February 13, 2018,
its proxy statement for its 2018 annual meeting of stockholders, which
was filed with the SEC on March 22, 2018, and its Current Report on Form
8-K, which was filed with the SEC on August 28, 2018. Information about
the directors and executive officers of Celgene is set forth in its
Annual Report on Form 10-K for the year ended December 31, 2017, which
was filed with the SEC on February 7, 2018, its proxy statement for its
2018 annual meeting of stockholders, which was filed with the SEC on
April 30, 2018, and its Current Reports on Form 8-K, which were filed
with the SEC on June 1, 2018, June 19, 2018 and November 2, 2018. Other
information regarding the participants in the proxy solicitations and a
description of their direct and indirect interests, by security holdings
or otherwise, will be contained in the joint proxy statement/prospectus
and other relevant materials to be filed with the SEC regarding the
proposed transaction when they become available. You may obtain these
documents (when they become available) free of charge through the
website maintained by the SEC at http://www.sec.gov
and from Investor Relations at Bristol-Myers Squibb or Celgene as
described above.
Cautionary Statement Regarding Forward-Looking
Statements
This communication contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. You can
generally identify forward-looking statements by the use of
forward-looking terminology such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,”
“might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or
“will,” or the negative thereof or other variations thereon or
comparable terminology. These forward-looking statements are only
predictions and involve known and unknown risks and uncertainties, many
of which are beyond Bristol-Myers Squibb’s and Celgene’s control.
Statements in this communication regarding Bristol-Myers Squibb, Celgene
and the combined company that are forward-looking, including projections
as to the anticipated benefits of the proposed acquisition of Celgene,
the impact of the proposed transaction on Bristol-Myers Squibb’s and
Celgene’s business and future financial and operating results, the
amount and timing of synergies from the proposed transaction, the terms
and scope of the expected financing for the proposed transaction, the
aggregate amount of indebtedness of the combined company following the
closing of the proposed transaction, expectations regarding cash flow
generation, accretion to non-GAAP earnings per share, capital structure,
debt repayment, adjusted leverage ratio and credit ratings following the
closing of the proposed transaction, Bristol-Myers Squibb’s ability and
intent to conduct a share repurchase program and declare future dividend
payments, the combined company’s pipeline, intellectual property
protection and R&D spend, the timing and probability of a payment
pursuant to the contingent value right consideration, and the closing
date for the proposed transaction, are based on management’s estimates,
assumptions and projections, and are subject to significant
uncertainties and other factors, many of which are beyond Bristol-Myers
Squibb’s and Celgene’s control. These factors include, among other
things, effects of the continuing implementation of governmental laws
and regulations related to Medicare, Medicaid, Medicaid managed care
organizations and entities under the Public Health Service 340B program,
pharmaceutical rebates and reimbursement, market factors, competitive
product development and approvals, pricing controls and pressures
(including changes in rules and practices of managed care groups and
institutional and governmental purchasers), economic conditions such as
interest rate and currency exchange rate fluctuations, judicial
decisions, claims and concerns that may arise regarding the safety and
efficacy of in-line products and product candidates, changes to
wholesaler inventory levels, variability in data provided by third
parties, changes in, and interpretation of, governmental regulations and
legislation affecting domestic or foreign operations, including tax
obligations, changes to business or tax planning strategies,
difficulties and delays in product development, manufacturing or sales
including any potential future recalls, patent positions and the
ultimate outcome of any litigation matter. These factors also include
the combined company’s ability to execute successfully its strategic
plans, including its business development strategy, the expiration of
patents or data protection on certain products, including assumptions
about the combined company’s ability to retain patent exclusivity of
certain products, the impact and result of governmental investigations,
the combined company’s ability to obtain necessary regulatory approvals
or obtaining these without delay, the risk that the combined company’s
products prove to be commercially successful or that contractual
milestones will be achieved. Similarly, there are uncertainties relating
to a number of other important factors, including: results of clinical
trials and preclinical studies, including subsequent analysis of
existing data and new data received from ongoing and future studies; the
content and timing of decisions made by the U.S. FDA and other
regulatory authorities, investigational review boards at clinical trial
sites and publication review bodies; the ability to enroll patients in
planned clinical trials; unplanned cash requirements and expenditures;
competitive factors; the ability to obtain, maintain and enforce patent
and other intellectual property protection for any product candidates;
the ability to maintain key collaborations; and general economic and
market conditions. Additional information concerning these risks,
uncertainties and assumptions can be found in Bristol-Myers Squibb’s and
Celgene’s respective filings with the SEC, including the risk factors
discussed in Bristol-Myers Squibb’s and Celgene’s most recent Annual
Reports on Form 10-K, as updated by their Quarterly Reports on Form 10-Q
and future filings with the SEC.
It should also be noted that projected financial information for the
combined businesses of Bristol-Myers Squibb and Celgene is based on
management’s estimates, assumptions and projections and has not been
prepared in conformance with the applicable accounting requirements of
Regulation S-X relating to pro forma financial information, and the
required pro forma adjustments have not been applied and are not
reflected therein. None of this information should be considered in
isolation from, or as a substitute for, the historical financial
statements of Bristol-Myers Squibb or Celgene. Important risk factors
could cause actual future results and other future events to differ
materially from those currently estimated by management, including, but
not limited to, the risks that: a condition to the closing of the
proposed acquisition may not be satisfied; a regulatory approval that
may be required for the proposed acquisition is delayed, is not obtained
or is obtained subject to conditions that are not anticipated;
Bristol-Myers Squibb is unable to achieve the synergies and value
creation contemplated by the proposed acquisition; Bristol-Myers Squibb
is unable to promptly and effectively integrate Celgene’s businesses;
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; the credit
ratings of the combined company declines following the proposed
acquisition; legal proceedings are instituted against Bristol-Myers
Squibb, Celgene or the combined company; Bristol-Myers Squibb, Celgene
or the combined company is unable to retain key personnel; and the
announcement or the consummation of the proposed acquisition has a
negative effect on the market price of the capital stock of
Bristol-Myers Squibb and Celgene or on Bristol-Myers Squibb’s and
Celgene’s operating results.
No assurances can be given that any of the events anticipated by the
forward-looking statements will transpire or occur, or if any of them do
occur, what impact they will have on the results of operations,
financial condition or cash flows of Bristol-Myers Squibb or Celgene.
Should any risks and uncertainties develop into actual events, these
developments could have a material adverse effect on the proposed
transaction and/or Bristol-Myers Squibb or Celgene, Bristol-Myers
Squibb’s ability to successfully complete the proposed transaction
and/or realize the expected benefits from the proposed transaction. You
are cautioned not to rely on Bristol-Myers Squibb’s and Celgene’s
forward-looking statements. These forward-looking statements are and
will be based upon management’s then-current views and assumptions
regarding future events and operating performance, and are applicable
only as of the dates of such statements. Neither Bristol-Myers Squibb
nor Celgene assumes any duty to update or revise forward-looking
statements, whether as a result of new information, future events or
otherwise, as of any future date.
|
BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUE FOR THE
THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 (Unaudited,
dollars in millions)
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
|
|
2018
|
|
2017
|
|
% Change
|
|
2018
|
|
2017
|
|
% Change
|
Three Months Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prioritized Brands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opdivo
|
|
|
|
$
|
1,804
|
|
$
|
1,361
|
|
33
|
%
|
|
$
|
1,136
|
|
|
$
|
795
|
|
43
|
%
|
Eliquis
|
|
|
|
|
1,705
|
|
|
1,363
|
|
25
|
%
|
|
|
979
|
|
|
|
768
|
|
27
|
%
|
Orencia
|
|
|
|
|
731
|
|
|
662
|
|
10
|
%
|
|
|
515
|
|
|
|
461
|
|
12
|
%
|
Sprycel
|
|
|
|
|
536
|
|
|
527
|
|
2
|
%
|
|
|
300
|
|
|
|
299
|
|
—
|
|
Yervoy
|
|
|
|
|
384
|
|
|
269
|
|
43
|
%
|
|
|
273
|
|
|
|
181
|
|
51
|
%
|
Empliciti
|
|
|
|
|
69
|
|
|
63
|
|
10
|
%
|
|
|
45
|
|
|
|
39
|
|
15
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Established Brands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
|
|
|
165
|
|
|
233
|
|
(29
|
)%
|
|
|
7
|
|
|
|
13
|
|
(46
|
)%
|
Reyataz Franchise
|
|
|
|
|
99
|
|
|
143
|
|
(31
|
)%
|
|
|
25
|
|
|
|
67
|
|
(63
|
)%
|
Sustiva Franchise
|
|
|
|
|
54
|
|
|
174
|
|
(69
|
)%
|
|
|
4
|
|
|
|
151
|
|
(97
|
)%
|
Hepatitis C Franchise
|
|
|
|
|
4
|
|
|
59
|
|
(93
|
)%
|
|
|
(15
|
)
|
|
|
13
|
|
**
|
Other Brands
|
|
|
|
|
422
|
|
|
595
|
|
(29
|
)%
|
|
|
74
|
|
|
|
104
|
|
(29
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
5,973
|
|
$
|
5,449
|
|
10
|
%
|
|
$
|
3,343
|
|
|
$
|
2,891
|
|
16
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
** In excess of +/- 100%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUE FOR THE
TWELVE MONTHS ENDED DECEMBER 31, 2018 AND 2017 (Unaudited,
dollars in millions)
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
|
|
2018
|
|
2017
|
|
% Change
|
|
2018
|
|
2017
|
|
% Change
|
Twelve Months Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prioritized Brands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opdivo
|
|
|
|
$
|
6,735
|
|
$
|
4,948
|
|
36
|
%
|
|
$
|
4,239
|
|
|
$
|
3,102
|
|
37
|
%
|
Eliquis
|
|
|
|
|
6,438
|
|
|
4,872
|
|
32
|
%
|
|
|
3,760
|
|
|
|
2,887
|
|
30
|
%
|
Orencia
|
|
|
|
|
2,710
|
|
|
2,479
|
|
9
|
%
|
|
|
1,875
|
|
|
|
1,704
|
|
10
|
%
|
Sprycel
|
|
|
|
|
2,000
|
|
|
2,005
|
|
—
|
|
|
|
1,091
|
|
|
|
1,105
|
|
(1
|
)%
|
Yervoy
|
|
|
|
|
1,330
|
|
|
1,244
|
|
7
|
%
|
|
|
941
|
|
|
|
908
|
|
4
|
%
|
Empliciti
|
|
|
|
|
247
|
|
|
231
|
|
7
|
%
|
|
|
164
|
|
|
|
151
|
|
9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Established Brands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
|
|
|
744
|
|
|
1,052
|
|
(29
|
)%
|
|
|
32
|
|
|
|
53
|
|
(40
|
)%
|
Reyataz Franchise
|
|
|
|
|
427
|
|
|
698
|
|
(39
|
)%
|
|
|
157
|
|
|
|
327
|
|
(52
|
)%
|
Sustiva Franchise
|
|
|
|
|
283
|
|
|
729
|
|
(61
|
)%
|
|
|
27
|
|
|
|
622
|
|
(96
|
)%
|
Hepatitis C Franchise
|
|
|
|
|
17
|
|
|
406
|
|
(96
|
)%
|
|
|
(16
|
)
|
|
|
109
|
|
**
|
Other Brands
|
|
|
|
|
1,630
|
|
|
2,112
|
|
(23
|
)%
|
|
|
316
|
|
|
|
390
|
|
(19
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
$
|
22,561
|
|
$
|
20,776
|
|
9
|
%
|
|
$
|
12,586
|
|
|
$
|
11,358
|
|
11
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
** In excess of +/- 100%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY CONSOLIDATED STATEMENTS OF
EARNINGS FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31,
2018 AND 2017 (Unaudited, dollars and shares in millions
except per share data)
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Net product sales
|
|
|
$
|
5,715
|
|
|
$
|
5,046
|
|
|
$
|
21,581
|
|
|
$
|
19,258
|
|
Alliance and other revenues
|
|
|
258
|
|
|
403
|
|
|
980
|
|
|
1,518
|
|
Total Revenues
|
|
|
5,973
|
|
|
5,449
|
|
|
22,561
|
|
|
20,776
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
1,690
|
|
|
1,681
|
|
|
6,547
|
|
|
6,094
|
|
Marketing, selling and administrative
|
|
|
1,336
|
|
|
1,316
|
|
|
4,551
|
|
|
4,751
|
|
Research and development
|
|
|
1,380
|
|
|
1,939
|
|
|
6,345
|
|
|
6,482
|
|
Other income (net)
|
|
|
20
|
|
|
(185
|
)
|
|
(892
|
)
|
|
(1,682
|
)
|
Total Expenses
|
|
|
4,426
|
|
|
4,751
|
|
|
16,551
|
|
|
15,645
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Before Income Taxes
|
|
|
1,547
|
|
|
698
|
|
|
6,010
|
|
|
5,131
|
|
Provision for Income Taxes
|
|
|
357
|
|
|
3,027
|
|
|
1,031
|
|
|
4,156
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings/(Loss)
|
|
|
1,190
|
|
|
(2,329
|
)
|
|
4,979
|
|
|
975
|
|
Net Earnings/(Loss) Attributable to Noncontrolling Interest
|
|
|
(2
|
)
|
|
(1
|
)
|
|
27
|
|
|
(32
|
)
|
Net Earnings/(Loss) Attributable to BMS
|
|
|
$
|
1,192
|
|
|
$
|
(2,328
|
)
|
|
$
|
4,952
|
|
|
$
|
1,007
|
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding:
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
1,632
|
|
1,635
|
|
1,633
|
|
1,645
|
Diluted
|
|
|
1,637
|
|
|
1,635
|
|
|
1,637
|
|
|
1,652
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per Common Share
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
0.73
|
|
|
$
|
(1.42
|
)
|
|
$
|
3.03
|
|
|
$
|
0.61
|
|
Diluted
|
|
|
$
|
0.73
|
|
|
$
|
(1.42
|
)
|
|
$
|
3.03
|
|
|
$
|
0.61
|
|
|
|
|
|
|
|
|
|
|
|
Other income (net)
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
$
|
48
|
|
|
$
|
51
|
|
|
$
|
183
|
|
|
$
|
196
|
|
Investment income
|
|
|
(55
|
)
|
|
(39
|
)
|
|
(173
|
)
|
|
(126
|
)
|
Loss/(gain) on equity investments
|
|
|
268
|
|
|
(6
|
)
|
|
512
|
|
|
(23
|
)
|
Provision for restructuring
|
|
|
29
|
|
|
86
|
|
|
131
|
|
|
293
|
|
Litigation and other settlements
|
|
|
24
|
|
|
2
|
|
|
34
|
|
|
(487
|
)
|
Equity in net income of affiliates
|
|
|
(20
|
)
|
|
(16
|
)
|
|
(93
|
)
|
|
(75
|
)
|
Divestiture (gains)/losses
|
|
|
—
|
|
|
(38
|
)
|
|
(178
|
)
|
|
(164
|
)
|
Royalties and licensing income
|
|
|
(295
|
)
|
|
(258
|
)
|
|
(1,353
|
)
|
|
(1,351
|
)
|
Transition and other service fees
|
|
|
(7
|
)
|
|
(5
|
)
|
|
(12
|
)
|
|
(37
|
)
|
Pension and postretirement
|
|
|
13
|
|
|
28
|
|
|
(27
|
)
|
|
(1
|
)
|
Intangible asset impairment
|
|
|
—
|
|
|
—
|
|
|
64
|
|
|
—
|
|
Loss on debt redemption
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
109
|
|
Other
|
|
|
15
|
|
|
10
|
|
|
20
|
|
|
(16
|
)
|
Other income (net)
|
|
|
$
|
20
|
|
|
$
|
(185
|
)
|
|
$
|
(892
|
)
|
|
$
|
(1,682
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY SPECIFIED ITEMS FOR THE
THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2018 AND 2017 (Unaudited,
dollars in millions)
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Impairment charges
|
|
|
$
|
7
|
|
|
$
|
18
|
|
|
$
|
17
|
|
|
$
|
146
|
|
Accelerated depreciation and other shutdown costs
|
|
|
11
|
|
|
—
|
|
|
41
|
|
|
3
|
|
Cost of products sold
|
|
|
18
|
|
|
18
|
|
|
58
|
|
|
149
|
|
|
|
|
|
|
|
|
|
|
|
Marketing, selling and administrative
|
|
|
1
|
|
|
1
|
|
|
2
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
License and asset acquisition charges
|
|
|
—
|
|
|
377
|
|
|
1,135
|
|
|
1,130
|
|
IPRD impairments
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
75
|
|
Site exit costs and other
|
|
|
22
|
|
|
151
|
|
|
79
|
|
|
383
|
|
Research and development
|
|
|
22
|
|
|
528
|
|
|
1,214
|
|
|
1,588
|
|
|
|
|
|
|
|
|
|
|
|
Loss/(gain) on equity investments
|
|
|
268
|
|
|
—
|
|
|
512
|
|
|
—
|
|
Provision for restructuring
|
|
|
29
|
|
|
86
|
|
|
131
|
|
|
293
|
|
Litigation and other settlements
|
|
|
28
|
|
|
—
|
|
|
28
|
|
|
(481
|
)
|
Divestiture gains
|
|
|
(1
|
)
|
|
(26
|
)
|
|
(177
|
)
|
|
(126
|
)
|
Royalties and licensing income
|
|
|
—
|
|
|
—
|
|
|
(75
|
)
|
|
(497
|
)
|
Pension and postretirement
|
|
|
26
|
|
|
71
|
|
|
121
|
|
|
162
|
|
Intangible asset impairment
|
|
|
—
|
|
|
—
|
|
|
64
|
|
|
—
|
|
Loss on debt redemption
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
109
|
|
Other income (net)
|
|
|
350
|
|
|
131
|
|
|
604
|
|
|
(540
|
)
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to pretax income
|
|
|
391
|
|
|
678
|
|
|
1,878
|
|
|
1,198
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes on specified items
|
|
|
(33
|
)
|
|
(138
|
)
|
|
(258
|
)
|
|
(87
|
)
|
Income taxes attributed to U.S. tax reform
|
|
|
(7
|
)
|
|
2,911
|
|
|
(56
|
)
|
|
2,911
|
|
Income taxes
|
|
|
(40
|
)
|
|
2,773
|
|
|
(314
|
)
|
|
2,824
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to net earnings
|
|
|
351
|
|
|
3,451
|
|
|
1,564
|
|
|
4,022
|
|
|
|
|
|
|
|
|
|
|
|
Noncontrolling interest
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59
|
)
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to net earnings used for diluted Non-GAAP EPS
calculation
|
|
|
$
|
351
|
|
|
$
|
3,451
|
|
|
$
|
1,564
|
|
|
$
|
3,963
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF CERTAIN GAAP
LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS FOR THE THREE AND
TWELVE MONTHS ENDED DECEMBER 31, 2018 AND 2017 (Unaudited,
dollars in millions)
|
|
|
|
|
Three Months Ended December 31, 2018
|
|
Twelve Months Ended December 31, 2018
|
|
|
|
GAAP
|
|
Specified Items(a)
|
|
Non- GAAP
|
|
GAAP
|
|
Specified Items(a)
|
|
Non- GAAP
|
Gross Profit
|
|
|
$
|
4,283
|
|
|
$
|
18
|
|
|
$
|
4,301
|
|
|
$
|
16,014
|
|
|
$
|
58
|
|
|
$
|
16,072
|
|
Marketing, selling and administrative
|
|
|
|
1,336
|
|
|
|
(1
|
)
|
|
|
1,335
|
|
|
|
4,551
|
|
|
|
(2
|
)
|
|
|
4,549
|
|
Research and development
|
|
|
|
1,380
|
|
|
|
(22
|
)
|
|
|
1,358
|
|
|
|
6,345
|
|
|
|
(1,214
|
)
|
|
|
5,131
|
|
Other income (net)
|
|
|
|
20
|
|
|
|
(350
|
)
|
|
|
(330
|
)
|
|
|
(892
|
)
|
|
|
(604
|
)
|
|
|
(1,496
|
)
|
Earnings Before Income Taxes
|
|
|
|
1,547
|
|
|
|
391
|
|
|
|
1,938
|
|
|
|
6,010
|
|
|
|
1,878
|
|
|
|
7,888
|
|
Provision for Income Taxes
|
|
|
|
357
|
|
|
|
(40
|
)
|
|
|
397
|
|
|
|
1,031
|
|
|
|
(314
|
)
|
|
|
1,345
|
|
Noncontrolling interest
|
|
|
|
(2
|
)
|
|
|
—
|
|
|
|
(2
|
)
|
|
|
27
|
|
|
|
—
|
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings Attributable to BMS used for Diluted EPS Calculation
|
|
|
$
|
1,192
|
|
|
$
|
351
|
|
|
$
|
1,543
|
|
|
$
|
4,952
|
|
|
$
|
1,564
|
|
|
$
|
6,516
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding - Diluted
|
|
|
|
1,637
|
|
|
|
1,637
|
|
|
|
1,637
|
|
|
|
1,637
|
|
|
|
1,637
|
|
|
|
1,637
|
|
Diluted Earnings Per Share
|
|
|
$
|
0.73
|
|
|
$
|
0.21
|
|
|
$
|
0.94
|
|
|
$
|
3.03
|
|
|
$
|
0.95
|
|
|
$
|
3.98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective Tax Rate
|
|
|
|
23.1
|
%
|
|
|
(2.6
|
)%
|
|
|
20.5
|
%
|
|
|
17.2
|
%
|
|
|
(0.1
|
)%
|
|
|
17.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2017
|
|
Twelve Months Ended December 31, 2017
|
|
|
|
GAAP
|
|
Specified Items(a)
|
|
Non- GAAP
|
|
GAAP
|
|
Specified Items(a)
|
|
Non- GAAP
|
Gross Profit
|
|
|
$
|
3,768
|
|
|
$
|
18
|
|
|
$
|
3,786
|
|
|
$
|
14,682
|
|
|
$
|
149
|
|
|
$
|
14,831
|
|
Marketing, selling and administrative
|
|
|
|
1,316
|
|
|
|
(1
|
)
|
|
|
1,315
|
|
|
|
4,751
|
|
|
|
(1
|
)
|
|
|
4,750
|
|
Research and development
|
|
|
|
1,939
|
|
|
|
(528
|
)
|
|
|
1,411
|
|
|
|
6,482
|
|
|
|
(1,588
|
)
|
|
|
4,894
|
|
Other income (net)
|
|
|
|
(185
|
)
|
|
|
(131
|
)
|
|
|
(316
|
)
|
|
|
(1,682
|
)
|
|
|
540
|
|
|
|
(1,142
|
)
|
Earnings Before Income Taxes
|
|
|
|
698
|
|
|
|
678
|
|
|
|
1,376
|
|
|
|
5,131
|
|
|
|
1,198
|
|
|
|
6,329
|
|
Provision for Income Taxes
|
|
|
|
3,027
|
|
|
|
2,773
|
|
|
|
254
|
|
|
|
4,156
|
|
|
|
2,824
|
|
|
|
1,332
|
|
Noncontrolling interest
|
|
|
|
(1
|
)
|
|
|
—
|
|
|
|
(1
|
)
|
|
|
(32
|
)
|
|
|
(59
|
)
|
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings Attributable to BMS used for Diluted EPS Calculation
|
|
|
$
|
(2,328
|
)
|
|
$
|
3,451
|
|
|
$
|
1,123
|
|
|
$
|
1,007
|
|
|
$
|
3,963
|
|
|
$
|
4,970
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding - Diluted
|
|
|
|
1,635
|
|
|
|
1,642
|
|
|
|
1,642
|
|
|
|
1,652
|
|
|
|
1,652
|
|
|
|
1,652
|
|
Diluted Earnings Per Share
|
|
|
$
|
(1.42
|
)
|
|
$
|
2.10
|
|
|
$
|
0.68
|
|
|
$
|
0.61
|
|
|
$
|
2.40
|
|
|
$
|
3.01
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective Tax Rate
|
|
|
|
433.7
|
%
|
|
|
(415.2
|
)%
|
|
|
18.5
|
%
|
|
|
81.0
|
%
|
|
|
(60.0
|
)%
|
|
|
21.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
Refer to the Specified Items schedule for further details. Effective
tax rate on the Specified Items represents the difference between
the GAAP and Non-GAAP effective tax rate.
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY NET CASH/(DEBT) CALCULATION AS
OF DECEMBER 31, 2018 AND SEPTEMBER 30, 2018 (Unaudited,
dollars in millions)
|
|
|
|
|
|
December 31, 2018
|
|
September 30, 2018
|
Cash and cash equivalents
|
|
|
|
$
|
6,911
|
|
|
$
|
5,408
|
|
Marketable securities - current
|
|
|
|
1,973
|
|
|
1,422
|
|
Marketable securities - non-current
|
|
|
|
1,775
|
|
|
2,017
|
|
Cash, cash equivalents and marketable securities
|
|
|
|
10,659
|
|
|
8,847
|
|
Short-term debt obligations
|
|
|
|
(1,703
|
)
|
|
(1,620
|
)
|
Long-term debt
|
|
|
|
(5,646
|
)
|
|
(5,687
|
)
|
Net cash position
|
|
|
|
$
|
3,310
|
|
|
$
|
1,540
|
|
|
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com:
https://www.businesswire.com/news/home/20190124005154/en/
Media:
Carrie Fernandez, 609-252-5222, carrie.fernandez@bms.com
Investor Relations:
John Elicker, 609-252-4611, john.elicker@bms.com
Tim
Power, 609-252-7509, timothy.power@bms.com
Bill
Szablewski, 609-252-5894, william.szablewski@bms.com
Source: Bristol-Myers Squibb Company