-
Increases Third Quarter Revenues 21% to $4.9 Billion
-
Posts Third Quarter GAAP EPS of $0.72 and Non-GAAP EPS of $0.77
-
Achieves Key Regulatory Milestones for Opdivo
-
Positive Advisory Opinion for the Treatment of Classical
Hodgkin Lymphoma in Europe
-
Application for Advanced Form of Bladder Cancer Accepted for
Priority Review in U.S., Validated in Europe
-
Announces Approval of $3 Billion Share Repurchase Authorization
-
Announces Operating Model Evolution for Sustained Growth
-
Increases 2016 GAAP and Non-GAAP EPS Guidance, Provides 2017
Guidance
NEW YORK--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) today reported results for the third
quarter of 2016 which were highlighted by strong sales and operating
performance, and continued growth for key products including Opdivo
and Eliquis.
The company raised full-year guidance for 2016 and provided guidance
expectations for 2017, announced a new $3 billion share repurchase
authorization, and announced an evolution of the company’s operating
model to focus resources behind the company’s highest priorities,
accelerate its pipeline and simplify infrastructure.
“Our third quarter was marked by strong commercial execution and solid
trends across our products and geographies,” said Giovanni
Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “While
we are disappointed with the results of CheckMate -026, a setback in
first-line lung in the short term, our overall strategic focus does not
change. Going forward, we see growth in both the near and long term to
continue to be driven by Opdivo, Eliquis and Orencia,
and by an exciting pipeline of specialty medicines over time. As we
focus on the future, we are evolving our operating model to more
effectively focus resources on key priorities and simplify execution to
deliver sustainable growth and to speed transformational medicines to
patients.”
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Third Quarter
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$ amounts in millions, except per share amounts
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2016
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2015
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Change
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Total Revenues
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$4,922
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$4,069
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21%
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GAAP Diluted EPS
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0.72
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0.42
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71%
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Non-GAAP Diluted EPS
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0.77
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0.39
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97%
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THIRD QUARTER FINANCIAL RESULTS
-
Bristol-Myers Squibb posted third quarter 2016 revenues of $4.9
billion, an increase of 21% compared to the same period a year ago.
Global revenues increased 22% adjusted for foreign exchange impact.
Excluding Erbitux,
global revenues increased 26% or 27% adjusted for foreign exchange
impact.
-
U.S. revenues increased 36% to $2.8 billion in the quarter compared to
the same period a year ago. International revenues increased 5%. When
adjusted for foreign exchange impact, international revenues increased
7%.
-
Gross margin as a percentage of revenues was 73.5% in the quarter
compared to 73.0% in the same period a year ago.
-
Marketing, selling and administrative expenses decreased 3% to $1.1
billion in the quarter.
-
Research and development expenses increased 1% to $1.1 billion in the
quarter.
-
The effective tax rate was 22.1% in the quarter, compared to 26.0% in
the third quarter last year.
-
The company reported net earnings attributable to Bristol-Myers Squibb
of $1.2 billion, or $0.72 per share, in the quarter compared to $706
million, or $0.42 per share, a year ago.
-
The company reported non-GAAP net earnings attributable to
Bristol-Myers Squibb of $1.3 billion, or $0.77 per share, in the third
quarter, compared to $648 million, or $0.39 per share, for the same
period in 2015. An overview of specified items is discussed under the
“Use of Non-GAAP Financial Information” section.
-
Cash, cash equivalents and marketable securities were $8.6 billion,
with a net cash position of $1.8 billion, as of September 30, 2016.
THIRD QUARTER PRODUCT AND PIPELINE UPDATE
Global revenues for the third quarter of 2016, compared to the third
quarter of 2015, were driven by Opdivo, which grew by $615
million; Eliquis, which grew 90%; Yervoy,
which grew 19%; Orencia, which grew 18%; and Sprycel,
which grew 15%.
Opdivo
-
In October, the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) recommended the approval of Opdivo
for the treatment of adult patients with relapsed or refractory
classical Hodgkin lymphoma (cHL) after autologous stem cell transplant
(ASCT) and treatment with brentuximab vedotin, making Opdivo
the first PD-1 inhibitor in a hematologic malignancy to receive
positive CHMP opinion. The decision was based on overall response rate
demonstrated by data from two trials, CheckMate -205 and CheckMate
-039. The CHMP recommendation will now be reviewed by the
European Commission (EC), which has the authority to approve medicines
for the European Union (EU).
-
In October, the U.S. Food and Drug Administration (FDA) accepted a
supplemental Biologics License Application (sBLA), which seeks to
expand the use of Opdivo to adult patients with locally
advanced unresectable or metastatic urothelial carcinoma (mUC) after
failure of prior platinum-containing therapy. The FDA granted the
application a priority review and previously granted Opdivo
Breakthrough Therapy Designation for mUC in June 2016. The FDA action
date is March 2, 2017.
-
In September, the EMA validated the company’s type II variation
application, seeking to extend the current indications for Opdivo
to include the treatment of mUC in adults after failure of prior
platinum-containing therapy. Validation of the application confirms
the submission is complete and begins the EMA’s centralized review
process. The application primarily included data from CheckMate -275,
a Phase 2, open-label, single-arm study assessing the safety and
efficacy of Opdivo in patients with locally advanced
unresectable or mUC that has progressed after a platinum-containing
therapy.
-
In October, during the European Society for Medical Oncology Congress
in Copenhagen, Denmark, the company announced results from eight
studies for Opdivo and the Opdivo + Yervoy
regimen:
-
CheckMate -057 and CheckMate -017: Updated results from these two
pivotal Phase 3 studies showed more than one-third of previously
treated metastatic non-small cell lung cancer (NSCLC) patients
experienced ongoing responses with Opdivo, compared to
no ongoing responses in the docetaxel arm. The median duration of
response (DOR) with Opdivo versus docetaxel in CheckMate
-057 was 17.2 months and 5.6 months, respectively, and in
CheckMate -017 it was 25.2 months and 8.4 months, respectively. In
CheckMate -057, patients with PD-L1 ≥1% had a median DOR of 17.2
months and in patients with PD-L1 <1%, it was 18.3 months. In both
studies, durability of response was observed in both PD-L1
expressors and non-expressors, and in CheckMate -057, one out of
the four complete responses occurred in a patient with <1% PD-L1
expression. There were no new safety signals identified for Opdivo in
the pooled safety analysis from both studies.
-
CheckMate -016: Updated results from this Phase 1 trial evaluating
the safety and tolerability of the Opdivo + Yervoy regimen
in previously treated and treatment-naïve patients with metastatic
renal cell carcinoma showed a confirmed objective response rate
(ORR) for the combination regimen of 40%. In the updated analysis,
durable responses were observed with the combination regimen. The
safety profile of the Opdivo + Yervoy combination in
metastatic renal cell carcinoma patients is consistent with
previous reports of the regimen in other studies.
-
CheckMate -026: The final primary analysis from this trial
investigating the use of Opdivo monotherapy as
first-line therapy in patients with advanced NSCLC whose tumors
expressed PD-L1 ≥1% showed it did not meet the primary endpoint of
superior progression-free survival (PFS) compared to chemotherapy.
In patients with ≥5% PD-L1 expression, the median PFS was 4.2
months with Opdivo and 5.9 months with platinum-based
doublet chemotherapy (stratified hazard ratio [HR]=1.15 [95% CI:
0.91, 1.45, p=0.25]). The topline results from this study
were disclosed on August 5, 2016.
-
CheckMate -141: New patient-centered quality-of-life data from an
exploratory endpoint in this pivotal Phase 3 trial evaluating Opdivo in
patients with recurrent or metastatic squamous cell carcinoma of
the head and neck after platinum therapy compared to
investigator’s choice of therapy showed Opdivo stabilized
patients’ symptoms and functioning, including physical, role and
social functioning across three separate instruments. Both PD-L1
expressors and non-expressors treated with investigator’s choice
of therapy experienced statistically significant worsening of
patient-reported outcomes from baseline to week 15 versus Opdivo.
In addition, Opdivo more than doubled the time to
deterioration for most functional domains measured and
significantly delayed the time to worsening symptoms of fatigue,
dyspnea and insomnia, compared to investigator’s choice of therapy.
-
CheckMate -275: In results from the trial, Opdivo had a
confirmed ORR, the primary endpoint, of 19.6% in
platinum-refractory patients with metastatic urothelial carcinoma.
Responses were observed in both PD-L1 expressors and
non-expressors. The confirmed ORR in patients expressing PD-L1 ≥1%
was 23.8% and 16.1% in patients expressing PD-L1 <1%. In patients
expressing PD-L1 ≥5%, the confirmed ORR was 28.4% and 15.8% in
patients expressing PD-L1 <5%. The safety profile of Opdivo
in this study was consistent with the safety profile of Opdivo
in other tumor types.
-
Two Phase 1 Studies: In these two Phase 1 studies testing
lirilumab in combination with Opdivo or Yervoy,
respectively, in patients with advanced refractory solid tumors,
the safety profile of the combination of lirilumab and Opdivo
therapy was similar to that of Opdivo monotherapy, with the
exception of an increased frequency of low grade infusion-related
reactions in patients treated with the lirilumab combinations.
Based on these data, further evaluation of lirilumab in
combination with Opdivo is warranted.
-
In October, during the International Symposium on Hodgkin Lymphoma in
Cologne, Germany, the company announced new results from CheckMate
-205, a multi-cohort, single-arm, Phase 2 trial evaluating Opdivo
in patients with cHL. These results from cohort C of the trial
included patients with cHL who had received brentuximab vedotin before
and/or after autologous hematopoietic stem cell transplantation
(auto-HSCT). After a median follow-up of 8.8 months, Opdivo
demonstrated an ORR as assessed by an independent radiologic review
committee of 73% overall and median progression-free survival of 11.2
months. The safety profile of Opdivo was consistent with
previously reported data in this tumor type, and no new clinically
meaningful safety signals were identified.
Yervoy
-
In October, during the European Society for Medical Oncology Congress
in Copenhagen, Denmark, the company announced results of CA184-029
(EORTC 18071), a Phase 3 trial evaluating stage III melanoma patients
who are at high risk of recurrence following complete surgical
resection. Yervoy 10 mg/kg compared with placebo significantly
improved overall survival (OS) (HR=0.72), a secondary endpoint, with
five-year OS rates at 65.4% in the Yervoy group and 54.4% in
the placebo group. In this updated five-year analysis, the
recurrence-free survival (primary endpoint) benefit observed
previously with Yervoy was maintained. The safety profile
remained consistent with the initial analysis with no new safety
signals.
Orencia
-
In September, the EC approved Orencia intravenous (IV) infusion
and subcutaneous (SC) injection, in combination with methotrexate
(MTX), for the treatment of highly active and progressive disease in
adult patients with rheumatoid arthritis (RA) not previously treated
with MTX. Orencia is the first biologic therapy with an
indication in the EU specifically applicable to the treatment of
MTX-naive RA patients with highly active and progressive disease. The
approval allows for the expanded marketing of Orencia in all 28
Member States of the EU.
BUSINESS DEVELOPMENT UPDATE
-
In September, the company entered into a clinical collaboration to
evaluate Nektar Therapeutics investigational medicine, NKTR-214 as a
potential combination treatment regimen with Opdivo in five
tumor types and seven potential indications. The Phase 1/2 clinical
trials will evaluate the potential for the combination of Opdivo and
NKTR-214 to show improved and sustained efficacy and tolerability
above the current standard of care in melanoma, kidney, colorectal,
bladder and NSCLC. An initial dose-escalation trial is underway with Opdivo
and NKTR-214.
NEW SHARE REPURCHASE
Bristol-Myers Squibb today announced its Board of Directors approved a
new $3 billion repurchase authorization for the Company’s common stock.
This is incremental to the current repurchase program, announced in June
2012, under which the Company has approximately $1.1 billion remaining.
The stock repurchase program does not have an expiration date. The
repurchases may be made either in the open market or through private
transactions and may be suspended or discontinued at any time.
The decision reflects the Company’s strong financial position and its
balanced approach to capital allocation, including a commitment to its
dividend and a disciplined approach to business development.
OPERATING MODEL
Bristol-Myers Squibb announced an evolution of its operating model to
drive the company’s continued success in the near and long term through
a more focused investment in commercial opportunities against key brands
and markets, a competitive and more agile R&D organization that can
accelerate the pipeline, streamlined operations and realigned
manufacturing capabilities that broaden biologics capabilities to
reflect current and future portfolio. The new operating model will
enable the company to deliver the strategic, financial and operational
flexibility necessary to invest in the highest priorities across the
company.
Although GAAP operating expenses may increase initially as charges are
incurred related to this evolution, the company expects non-GAAP
operating expenses to be roughly flat with 2016 levels through 2020.
2016 & 2017 FINANCIAL GUIDANCE
Bristol-Myers Squibb is increasing its 2016 GAAP EPS guidance range from
$2.43 - $2.53 to $2.62 - $2.72. The company is increasing its non-GAAP
EPS guidance range from $2.55 - $2.65 to $2.80 - $2.90. Both GAAP and
non-GAAP guidance assume current exchange rates. Revised 2016 GAAP and
non-GAAP line-item guidance assumptions include:
-
Worldwide revenues increasing in the high-teens.
-
Gross margin as a percentage of revenues to be approximately 75%.
-
Marketing, selling and administrative expenses to remain flat.
-
Research and development expenses decreasing 30% to 35% for GAAP and
increasing in the high-single digit range for non-GAAP.
-
An effective tax rate between 25% to 26% for GAAP and 22% to 23% for
non-GAAP.
Bristol-Myers Squibb expects 2017 GAAP EPS between $2.47 and $2.67 and
non-GAAP EPS between $2.85 and $3.05.
The financial guidance excludes the impact of any potential future
strategic acquisitions and divestitures, and any specified items that
have not yet been identified and quantified. The non-GAAP 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 gains or losses, pension, legal and other
contractual settlement charges 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 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.
Statement on Cautionary Factors
This press release contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, statements relating to goals, plans and
projections regarding the company’s financial position, results of
operations, market position, product development and business strategy.
These statements may be identified by the fact that they use words such
as "anticipate", "estimates", "should", "expect", "guidance", "project",
"intend", "plan", "believe" and other words and terms of similar meaning
in connection with any discussion of future operating or financial
performance. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties, including
factors that could delay, divert or change any of them, and could cause
actual outcomes and results to differ materially from current
expectations. 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 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 company’s ability to retain patent exclusivity of
certain products, and the impact and result of governmental
investigations. There can be no guarantees with respect to pipeline
products that future clinical studies will support the data described in
this release, that the compounds will receive necessary regulatory
approvals, or that they will prove to be commercially successful; nor
are there guarantees that regulatory approvals will be sought, or sought
within currently expected timeframes, or that contractual milestones
will be achieved. For further details and a discussion of these and
other risks and uncertainties, see the company's periodic reports,
including the annual report on Form 10-K, quarterly reports on Form 10-Q
and current reports on Form 8-K, filed with or furnished to the
Securities and Exchange Commission. The company undertakes no obligation
to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.
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 October 27, 2016, at 10:30 a.m. EDT
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 877-258-2708 or international
647-252-4456, confirmation code: 91351854. 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 1:30 p.m. EDT on
October 27 through 11:59 p.m. EST on November 10, 2016. The replay will
also be available through http://investor.bms.com
or by calling the U.S. toll free 855-859-2056 or international
404-537-3406, confirmation code: 91351854.
For more information, contact: Ken Dominski, 609-252-5251, ken.dominski@bms.com,
Communications; John Elicker, 609-252-4611, john.elicker@bms.com,
or Bill Szablewski, 609-252-5894, william.szablewski@bms.com,
Investor Relations.
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|
|
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
|
|
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
|
Three Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Key Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Empliciti
|
|
|
|
|
$
|
41
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
36
|
|
|
$
|
—
|
|
|
N/A
|
|
Erbitux(a)
|
|
|
|
|
—
|
|
|
167
|
|
|
(100
|
)%
|
|
—
|
|
|
165
|
|
|
(100
|
)%
|
|
Opdivo
|
|
|
|
|
920
|
|
|
305
|
|
|
**
|
|
712
|
|
|
268
|
|
|
**
|
|
Sprycel
|
|
|
|
|
472
|
|
|
411
|
|
|
15
|
%
|
|
259
|
|
|
215
|
|
|
20
|
%
|
|
Yervoy
|
|
|
|
|
285
|
|
|
240
|
|
|
19
|
%
|
|
222
|
|
|
121
|
|
|
83
|
%
|
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eliquis
|
|
|
|
|
884
|
|
|
466
|
|
|
90
|
%
|
|
512
|
|
|
245
|
|
|
**
|
|
Immunoscience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orencia
|
|
|
|
|
572
|
|
|
484
|
|
|
18
|
%
|
|
387
|
|
|
330
|
|
|
17
|
%
|
|
Virology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
|
|
|
306
|
|
|
320
|
|
|
(4
|
)%
|
|
17
|
|
|
25
|
|
|
(32
|
)%
|
|
Hepatitis C Franchise
|
|
|
|
|
379
|
|
|
402
|
|
|
(6
|
)%
|
|
192
|
|
|
111
|
|
|
73
|
%
|
|
Reyataz Franchise
|
|
|
|
|
238
|
|
|
270
|
|
|
(12
|
)%
|
|
125
|
|
|
149
|
|
|
(16
|
)%
|
|
Sustiva Franchise
|
|
|
|
|
275
|
|
|
333
|
|
|
(17
|
)%
|
|
234
|
|
|
280
|
|
|
(16
|
)%
|
|
Neuroscience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abilify(b)
|
|
|
|
|
29
|
|
|
46
|
|
|
(37
|
)%
|
|
—
|
|
|
18
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mature Products and All Other
|
|
|
|
|
521
|
|
|
625
|
|
|
(17
|
)%
|
|
94
|
|
|
117
|
|
|
(20
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
$
|
4,922
|
|
|
$
|
4,069
|
|
|
21
|
%
|
|
$
|
2,790
|
|
|
$
|
2,044
|
|
|
36
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
**
|
|
In excess of +/- 100%
|
|
|
|
|
|
(a)
|
|
Erbitux is a trademark of ImClone LLC. ImClone LLC is a
wholly-owned subsidiary of Eli Lilly and Company.
|
|
(b)
|
|
Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
|
|
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
|
Nine Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Key Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Empliciti
|
|
|
|
|
$
|
103
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
97
|
|
|
$
|
—
|
|
|
N/A
|
|
Erbitux
|
|
|
|
|
—
|
|
|
501
|
|
|
(100
|
)%
|
|
—
|
|
|
487
|
|
|
(100
|
)%
|
|
Opdivo
|
|
|
|
|
2,464
|
|
|
467
|
|
|
**
|
|
1,949
|
|
|
413
|
|
|
**
|
|
Sprycel
|
|
|
|
|
1,330
|
|
|
1,191
|
|
|
12
|
%
|
|
702
|
|
|
601
|
|
|
17
|
%
|
|
Yervoy
|
|
|
|
|
789
|
|
|
861
|
|
|
(8
|
)%
|
|
600
|
|
|
438
|
|
|
37
|
%
|
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eliquis
|
|
|
|
|
2,395
|
|
|
1,258
|
|
|
90
|
%
|
|
1,424
|
|
|
688
|
|
|
**
|
|
Immunoscience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orencia
|
|
|
|
|
1,640
|
|
|
1,345
|
|
|
22
|
%
|
|
1,109
|
|
|
899
|
|
|
23
|
%
|
|
Virology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
|
|
|
896
|
|
|
1,003
|
|
|
(11
|
)%
|
|
49
|
|
|
108
|
|
|
(55
|
)%
|
|
Hepatitis C Franchise
|
|
|
|
|
1,352
|
|
|
1,145
|
|
|
18
|
%
|
|
745
|
|
|
111
|
|
|
**
|
|
Reyataz Franchise
|
|
|
|
|
706
|
|
|
867
|
|
|
(19
|
)%
|
|
367
|
|
|
449
|
|
|
(18
|
)%
|
|
Sustiva Franchise
|
|
|
|
|
819
|
|
|
940
|
|
|
(13
|
)%
|
|
689
|
|
|
772
|
|
|
(11
|
)%
|
|
Neuroscience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abilify
|
|
|
|
|
97
|
|
|
707
|
|
|
(86
|
)%
|
|
—
|
|
|
593
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mature Products and All Other
|
|
|
|
|
1,593
|
|
|
1,988
|
|
|
(20
|
)%
|
|
284
|
|
|
366
|
|
|
(22
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
$
|
14,184
|
|
|
$
|
12,273
|
|
|
16
|
%
|
|
$
|
8,015
|
|
|
$
|
5,925
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars and shares in millions except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Net product sales
|
|
|
|
|
|
$
|
4,492
|
|
|
$
|
3,552
|
|
|
$
|
12,888
|
|
|
$
|
10,183
|
|
|
Alliance and other revenues
|
|
|
|
|
|
430
|
|
|
517
|
|
|
1,296
|
|
|
2,090
|
|
|
Total Revenues
|
|
|
|
|
|
4,922
|
|
|
4,069
|
|
|
14,184
|
|
|
12,273
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
|
|
|
1,305
|
|
|
1,097
|
|
|
3,563
|
|
|
2,957
|
|
|
Marketing, selling and administrative
|
|
|
|
|
|
1,144
|
|
|
1,176
|
|
|
3,450
|
|
|
3,340
|
|
|
Research and development
|
|
|
|
|
|
1,138
|
|
|
1,132
|
|
|
3,540
|
|
|
4,004
|
|
|
Other (income)/expense
|
|
|
|
|
|
(224
|
)
|
|
(323
|
)
|
|
(1,198
|
)
|
|
(515
|
)
|
|
Total Expenses
|
|
|
|
|
|
3,363
|
|
|
3,082
|
|
|
9,355
|
|
|
9,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Before Income Taxes
|
|
|
|
|
|
1,559
|
|
|
987
|
|
|
4,829
|
|
|
2,487
|
|
|
Provision for Income Taxes
|
|
|
|
|
|
344
|
|
|
257
|
|
|
1,220
|
|
|
668
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Earnings
|
|
|
|
|
|
1,215
|
|
|
730
|
|
|
3,609
|
|
|
1,819
|
|
|
Net Earnings Attributable to Noncontrolling Interest
|
|
|
|
|
|
13
|
|
|
24
|
|
|
46
|
|
|
57
|
|
|
Net Earnings Attributable to BMS
|
|
|
|
|
|
$
|
1,202
|
|
|
$
|
706
|
|
|
$
|
3,563
|
|
|
$
|
1,762
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
|
1,671
|
|
|
1,668
|
|
|
1,670
|
|
|
1,666
|
|
|
Diluted
|
|
|
|
|
|
1,679
|
|
|
1,678
|
|
|
1,679
|
|
|
1,677
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per Common Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
|
$
|
0.72
|
|
|
$
|
0.42
|
|
|
$
|
2.13
|
|
|
$
|
1.06
|
|
|
Diluted
|
|
|
|
|
|
$
|
0.72
|
|
|
$
|
0.42
|
|
|
$
|
2.12
|
|
|
$
|
1.05
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (Income)/Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
|
|
|
$
|
42
|
|
|
$
|
41
|
|
|
$
|
127
|
|
|
$
|
141
|
|
|
Investment income
|
|
|
|
|
|
(32
|
)
|
|
(18
|
)
|
|
(81
|
)
|
|
(74
|
)
|
|
Provision for restructuring
|
|
|
|
|
|
19
|
|
|
10
|
|
|
41
|
|
|
50
|
|
|
Litigation and other settlements
|
|
|
|
|
|
(1
|
)
|
|
(2
|
)
|
|
48
|
|
|
14
|
|
|
Equity in net income of affiliates
|
|
|
|
|
|
(19
|
)
|
|
(19
|
)
|
|
(65
|
)
|
|
(67
|
)
|
|
Divestiture gains
|
|
|
|
|
|
(21
|
)
|
|
(208
|
)
|
|
(574
|
)
|
|
(370
|
)
|
|
Royalties and licensing income
|
|
|
|
|
|
(158
|
)
|
|
(63
|
)
|
|
(579
|
)
|
|
(258
|
)
|
|
Transition and other service fees
|
|
|
|
|
|
(57
|
)
|
|
(37
|
)
|
|
(184
|
)
|
|
(91
|
)
|
|
Pension charges
|
|
|
|
|
|
19
|
|
|
48
|
|
|
66
|
|
|
111
|
|
|
Intangible asset impairment
|
|
|
|
|
|
—
|
|
|
—
|
|
|
15
|
|
|
13
|
|
|
Equity investment impairment
|
|
|
|
|
|
—
|
|
|
—
|
|
|
45
|
|
|
—
|
|
|
Written option adjustment
|
|
|
|
|
|
—
|
|
|
(87
|
)
|
|
—
|
|
|
(123
|
)
|
|
Loss on debt redemption
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
180
|
|
|
Other
|
|
|
|
|
|
(16
|
)
|
|
12
|
|
|
(57
|
)
|
|
(41
|
)
|
|
Other (income)/expense
|
|
|
|
|
|
$
|
(224
|
)
|
|
$
|
(323
|
)
|
|
$
|
(1,198
|
)
|
|
$
|
(515
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Cost of products sold(a)
|
|
|
|
|
|
$
|
7
|
|
|
$
|
15
|
|
|
$
|
15
|
|
|
$
|
74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketing, selling and administrative
|
|
|
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and asset acquisition charges
|
|
|
|
|
|
45
|
|
|
94
|
|
|
309
|
|
|
1,125
|
|
|
Other
|
|
|
|
|
|
14
|
|
|
15
|
|
|
40
|
|
|
17
|
|
|
Research and development
|
|
|
|
|
|
59
|
|
|
109
|
|
|
349
|
|
|
1,142
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for restructuring
|
|
|
|
|
|
19
|
|
|
10
|
|
|
41
|
|
|
50
|
|
|
Divestiture gains
|
|
|
|
|
|
(13
|
)
|
|
(198
|
)
|
|
(559
|
)
|
|
(358
|
)
|
|
Pension charges
|
|
|
|
|
|
19
|
|
|
48
|
|
|
66
|
|
|
111
|
|
|
Written option adjustment
|
|
|
|
|
|
—
|
|
|
(87
|
)
|
|
—
|
|
|
(123
|
)
|
|
Litigation and other settlements
|
|
|
|
|
|
(3
|
)
|
|
—
|
|
|
40
|
|
|
15
|
|
|
Intangible asset impairment
|
|
|
|
|
|
—
|
|
|
—
|
|
|
15
|
|
|
13
|
|
|
Loss on debt redemption
|
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
180
|
|
|
Other (income)/expense
|
|
|
|
|
|
22
|
|
|
(227
|
)
|
|
(397
|
)
|
|
(112
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to pretax income
|
|
|
|
|
|
88
|
|
|
(101
|
)
|
|
(33
|
)
|
|
1,110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax on items above
|
|
|
|
|
|
(3
|
)
|
|
43
|
|
|
156
|
|
|
(141
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to net earnings
|
|
|
|
|
|
$
|
85
|
|
|
$
|
(58
|
)
|
|
$
|
123
|
|
|
$
|
969
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
Specified items in cost of products sold are accelerated
depreciation, asset impairment and other shutdown costs.
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE
ITEMS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2016
|
|
|
|
Nine Months Ended September 30, 2016
|
|
|
|
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
|
Gross Profit
|
|
|
|
|
$
|
3,617
|
|
|
$
|
7
|
|
|
$
|
3,624
|
|
|
|
|
$
|
10,621
|
|
|
$
|
15
|
|
|
$
|
10,636
|
|
|
Marketing, selling and administrative
|
|
|
|
|
1,144
|
|
|
—
|
|
|
1,144
|
|
|
|
|
3,450
|
|
|
—
|
|
|
3,450
|
|
|
Research and development
|
|
|
|
|
1,138
|
|
|
(59
|
)
|
|
1,079
|
|
|
|
|
3,540
|
|
|
(349
|
)
|
|
3,191
|
|
|
Other (income)/expense
|
|
|
|
|
(224
|
)
|
|
(22
|
)
|
|
(246
|
)
|
|
|
|
(1,198
|
)
|
|
397
|
|
|
(801
|
)
|
|
Effective Tax Rate
|
|
|
|
|
22.1
|
%
|
|
(1.0
|
)%
|
|
21.1
|
%
|
|
|
|
25.3
|
%
|
|
(3.1
|
)%
|
|
22.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2015
|
|
|
|
Nine Months Ended September 30, 2015
|
|
|
|
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
|
Gross Profit
|
|
|
|
|
$
|
2,972
|
|
|
$
|
15
|
|
|
$
|
2,987
|
|
|
|
|
$
|
9,316
|
|
|
$
|
74
|
|
|
$
|
9,390
|
|
|
Marketing, selling and administrative
|
|
|
|
|
1,176
|
|
|
(2
|
)
|
|
1,174
|
|
|
|
|
3,340
|
|
|
(6
|
)
|
|
3,334
|
|
|
Research and development
|
|
|
|
|
1,132
|
|
|
(109
|
)
|
|
1,023
|
|
|
|
|
4,004
|
|
|
(1,142
|
)
|
|
2,862
|
|
|
Other (income)/expense
|
|
|
|
|
(323
|
)
|
|
227
|
|
|
(96
|
)
|
|
|
|
(515
|
)
|
|
112
|
|
|
(403
|
)
|
|
Effective Tax Rate
|
|
|
|
|
26.0
|
%
|
|
(1.8
|
)%
|
|
24.2
|
%
|
|
|
|
26.9
|
%
|
|
(4.4
|
)%
|
|
22.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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
RECONCILIATION OF GAAP EPS TO NON-GAAP EPS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
(Unaudited, dollars and shares in millions except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Net Earnings Attributable to BMS used for Diluted EPS Calculation -
GAAP
|
|
|
|
|
$
|
1,202
|
|
|
$
|
706
|
|
|
$
|
3,563
|
|
|
$
|
1,762
|
|
Less Specified Items*
|
|
|
|
|
85
|
|
|
(58
|
)
|
|
123
|
|
|
969
|
|
Net Earnings used for Diluted EPS Calculation – Non-GAAP
|
|
|
|
|
$
|
1,287
|
|
|
$
|
648
|
|
|
$
|
3,686
|
|
|
$
|
2,731
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding Diluted
|
|
|
|
|
1,679
|
|
|
1,678
|
|
|
1,679
|
|
|
1,677
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted Earnings Per Share — GAAP
|
|
|
|
|
$
|
0.72
|
|
|
$
|
0.42
|
|
|
$
|
2.12
|
|
|
$
|
1.05
|
|
Diluted EPS Attributable to Specified Items
|
|
|
|
|
0.05
|
|
|
(0.03
|
)
|
|
0.08
|
|
|
0.58
|
|
Diluted Earnings Per Share — Non-GAAP
|
|
|
|
|
$
|
0.77
|
|
|
$
|
0.39
|
|
|
$
|
2.20
|
|
|
$
|
1.63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Refer to the Specified Items schedule for further details.
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF SEPTEMBER 30, 2016 AND JUNE 30, 2016
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2016
|
|
June 30, 2016
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
3,432
|
|
|
$
|
2,934
|
|
|
Marketable securities - current
|
|
|
|
|
2,128
|
|
|
1,717
|
|
|
Marketable securities - non-current
|
|
|
|
|
3,035
|
|
|
3,281
|
|
|
Cash, cash equivalents and marketable securities
|
|
|
|
|
8,595
|
|
|
7,932
|
|
|
Short-term borrowings and current portion of long-term debt
|
|
|
|
|
(990
|
)
|
|
(155
|
)
|
|
Long-term debt
|
|
|
|
|
(5,836
|
)
|
|
(6,581
|
)
|
|
Net cash position
|
|
|
|
|
$
|
1,769
|
|
|
$
|
1,196
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20161027005357/en/
Source: Bristol-Myers Squibb Company