-
Increases Second Quarter Revenues 17% to $4.9 Billion
-
Posts Second Quarter GAAP and Non-GAAP EPS of $0.69
-
Achieves Important Regulatory Milestones in Immuno-Oncology
-
Opdivo + Yervoy Regimen Approved in Europe for
Metastatic Melanoma
-
Opdivo Approved in the U.S. for the Treatment of
Classical Hodgkin Lymphoma
-
Opdivo Granted Breakthrough Therapy Designation
for Advanced Form of Bladder Cancer
-
Empliciti Approved in Europe for Combination
Treatment for Multiple Myeloma
-
Opdivo Application for Squamous Cell Carcinoma of
the Head and Neck Accepted in the U.S., Europe and Japan
-
Increases 2016 GAAP EPS Guidance Range to $2.43 - $2.53 and
Non-GAAP EPS Guidance Range to $2.55 - $2.65
NEW YORK--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) today reported results for the second
quarter of 2016, which were highlighted by strong sales, key regulatory
and clinical milestones in Immuno-Oncology and business development
transactions that strengthened the company’s Immuno-Oncology pipeline.
“During the second quarter we delivered strong sales and earnings
growth, achieved important regulatory milestones with Opdivo
across multiple types of cancer, and further advanced our leadership in
Immuno-Oncology through the breadth of the clinical data we presented at
ASCO,” said Giovanni
Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “I am
confident strong performance of our in-line products, progress with our
diversified pipeline and our focused approach to business development
position us well for continued success.”
|
|
|
|
|
Second Quarter
|
$ amounts in millions, except per share amounts
|
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
Change
|
Total Revenues
|
|
$4,871
|
|
$4,163
|
|
17%
|
GAAP Diluted EPS
|
|
0.69
|
|
(0.08)
|
|
**
|
Non-GAAP Diluted EPS
|
|
0.69
|
|
0.53
|
|
30%
|
|
|
|
|
|
|
|
**In excess of +/- 100%
SECOND QUARTER FINANCIAL RESULTS
-
Bristol-Myers Squibb posted second quarter 2016 revenues of $4.9
billion, an increase of 17% compared to the same period a year ago.
Global revenues increased 18% adjusted for foreign exchange impact.
Excluding Abilify
and Erbitux,
global revenues increased 24% or 26% adjusted for foreign exchange
impact.
-
U.S. revenues increased 46% to $2.7 billion in the quarter compared to
the same period a year ago. International revenues decreased 6%
primarily from lower Hepatitis C Franchise sales in Japan and France.
When adjusted for foreign exchange impact, international revenues
decreased 4%.
-
Gross margin as a percentage of revenues was 75.2% in the quarter
compared to 75.7% in the same period a year ago.
-
Marketing, selling and administrative expenses increased 9% to $1.2
billion in the quarter.
-
Research and development expenses decreased 32% to $1.3 billion in the
quarter. Research and development expenses in the second quarter of
2015 include an $800 million charge resulting from the Flexus
acquisition.
-
The effective tax rate was 26.4% in the quarter, compared to 311.5% in
the second quarter last year. The second quarter 2015 Flexus
acquisition was non-deductible for tax purposes.
-
The company reported net earnings attributable to Bristol-Myers Squibb
of $1.2 billion, or $0.69 per share, in the quarter compared to a net
loss of $130 million, or $0.08 per share, a year ago. The results in
the second quarter of 2015 include a $0.48 per share charge from the
Flexus acquisition.
-
The company reported non-GAAP net earnings attributable to
Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the
second quarter, compared to $890 million, or $0.53 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 $7.9 billion,
with a net cash position of $1.2 billion, as of June 30, 2016.
SECOND QUARTER PRODUCT AND PIPELINE UPDATE
Global revenues for the second quarter of 2016, compared to the second
quarter of 2015, were driven by Opdivo, which grew by $718
million; Eliquis,
which grew 78%; Orencia,
which grew 29%; Hepatitis C Franchise, which grew 14%; and Sprycel,
which grew 11%.
Opdivo
-
In July, the U.S. Food and Drug Administration (FDA) accepted for
priority review and the European Medicines Agency (EMA) validated the
applications we submitted for Opdivo for patients with
previously treated recurrent or metastatic squamous cell carcinoma of
the head and neck (SCCHN). Additionally, in Japan, Bristol-Myers
Squibb’s partner Ono Pharmaceuticals submitted an application for Opdivo
in SCCHN. The three submissions were based on CheckMate -141, a
pivotal Phase 3 open-label, randomized study, that evaluated the
overall survival (OS) of Opdivo in patients with SCCHN after
platinum therapy compared to investigator’s choice of therapy
(methotrexate, docetaxel, or cetuximab). This study was stopped early
in January 2016 because an assessment conducted by the independent
Data Monitoring Committee concluded the study met its primary endpoint
of OS. The projected FDA action date is November 11, 2016.
-
In June, the FDA granted Breakthrough Therapy Designation to Opdivo
for the potential indication of unresectable locally advanced or
metastatic urothelial carcinoma that has progressed on or after a
platinum-containing regimen. As part of the Breakthrough Therapy
Designation submission, the company shared for the FDA’s review
results from Phase 2 study CA209-275 and other supportive data
investigating Opdivo in these previously treated bladder cancer
patients.
-
In May, the FDA approved Opdivo for the treatment of patients
with classical Hodgkin lymphoma (cHL) who have relapsed or progressed
after autologous hematopoietic stem cell transplantation (auto-HSCT)
and post-transplantation brentuximab vedotin. This accelerated
approval was based on overall response rate. This first approval of a
PD-1 inhibitor for cHL patients who have relapsed or progressed after
auto-HSCT and post-transplantation brentuximab vedotin is based on a
combined analysis of data from the Phase 2 CheckMate -205 and the
Phase 1 CheckMate -039 study. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials.
-
In May, the European Commission (EC) approved Opdivo in
combination with Yervoy
for the treatment of advanced unresectable or metastatic melanoma in
adults, representing the first and only approved combination of two
Immuno-Oncology (I-O) agents in the European Union (EU). The approval
is based on the results of the Phase 3 study CheckMate -067, the first
Phase 3, double-blind, randomized study, in which the Opdivo + Yervoy
regimen and Opdivo monotherapy demonstrated superior
progression-free survival (PFS) and objective response rates (ORR) in
patients with advanced melanoma, regardless of BRAF mutational status,
versus Yervoy alone. This approval allows for the marketing of
the Opdivo + Yervoy regimen in all 28 Member States of
the EU.
-
In June, during the Congress of the European Hematology Association
(EHA) in Copenhagen, Denmark, the company announced results from
CheckMate -205, a Phase 2 registrational study evaluating Opdivo
in patients with cHL. The primary endpoint of ORR per an independent
radiologic review committee (IRRC) was 66%. In an exploratory
analysis, the authors observed 72% of patients who did not respond to
the most recent prior brentuximab vedotin treatment did respond to Opdivo.
The safety profile of Opdivo in CheckMate -205 was consistent
with previously reported data in this tumor type.
-
In June, during ASCO in Chicago, the company announced results from
eight studies for Opdivo and the Opdivo + Yervoy
regimen:
-
CheckMate -067: In the pivotal Phase 3 study evaluating the Opdivo
+ Yervoy regimen or Opdivo monotherapy
versus Yervoy monotherapy in patients with previously
untreated advanced melanoma, including both BRAF V600
mutation positive or BRAF wild-type advanced melanoma,
at a minimum follow-up of 18 months, the Opdivo + Yervoy regimen
demonstrated continued clinical benefit with a 58% reduction in
the risk of disease progression versus Yervoy monotherapy,
while Opdivo monotherapy demonstrated a 45% risk reduction
versus Yervoy alone. The safety profile of the Opdivo +
Yervoy combination regimen in CheckMate -067 was consistent
with previously reported studies of the combination.
-
CheckMate -069: In a post-hoc analysis from the Phase 2 study
evaluating patients with previously untreated unresectable or
metastatic melanoma who received either the Opdivo + Yervoy
regimen or Yervoy alone, durable responses were observed
with the combination regimen in a subgroup of 35 patients who
discontinued therapy due to treatment-related adverse events and
appeared consistent with the overall randomized patient
population. Among this subgroup of patients, the ORR was 66%, and
20% achieved a complete response, with a minimum follow-up of two
years. At two years, the median duration of response was not
reached and 74% remain in response. The safety profile of the Opdivo
+ Yervoy regimen in CheckMate -069 was consistent with
previously reported studies of the combination.
-
CA209-003: In this Phase 1 study evaluating Opdivo in
patients with previously treated advanced renal cell carcinoma
(RCC), in which OS is an exploratory endpoint, 38% of patients
were alive at four years and 34% of patients were alive at five
years. The long-term safety profile of Opdivo was
consistent with previously reported studies.
-
CA209-010: In this Phase 2 study evaluating Opdivo in
patients with previously treated advanced RCC in which OS was a
secondary endpoint, 29% of patients were alive at four years. The
long-term safety profile of Opdivo was consistent with
previously reported studies.
-
CheckMate -025: In this pivotal Phase 3 study comparing Opdivo versus
everolimus in patients with advanced RCC who received prior
anti-angiogenic therapy, 55% of patients treated with Opdivo experienced
a clinically meaningful improvement in disease-related symptoms,
as defined in the study, versus 37% of patients treated with
everolimus. This additional analysis of health-related quality of
life data was a secondary endpoint in the study.
-
CheckMate -142: In this Phase 2 study evaluating Opdivo alone
or in combination with Yervoy in patients with previously
treated metastatic colorectal cancer, including those with high
microsatellite instability (MSI), the primary endpoint of
investigator-assessed ORR for MSI-high metastatic colorectal
cancer patients was 26% for Opdivo monotherapy and 33% for
the Opdivo + Yervoy combination regimen. The
six-month progression-free survival rates were 46% for Opdivo
monotherapy and 67% for the Opdivo + Yervoy combination
in patients with MSI-high metastatic colorectal cancer. The safety
profile of Opdivo alone or in combination with Yervoy was
consistent with other tumor types and prior combination studies.
-
CheckMate -032: In this Phase 1/2 study evaluating Opdivo
in patients with metastatic urothelial cancer, the most common
type of bladder cancer, after platinum-based therapy, the primary
endpoint of investigator-assessed confirmed ORR was 24% in
patients treated with Opdivo, with a minimum follow-up of
nine months. At one year, patients treated with Opdivo had
an OS rate, a secondary endpoint, of 46%, with a median OS of 9.72
months. Response rates by tumor PD-L1 expression, evaluated as an
exploratory endpoint, were similar regardless of PD-L1 expression
levels. The safety profile of Opdivo in CheckMate -032 was
consistent with the known safety profile of Opdivo in other
tumor types.
-
CheckMate -012: In this Phase 1b trial evaluating Opdivo and
Yervoy in patients with chemotherapy-naïve advanced
non-small cell lung cancer (NSCLC), findings from a pooled
analysis of two Opdivo + Yervoy combination regimen
cohorts [3 mg/kg of Opdivo every two weeks plus 1 mg/kg of Yervoy
either every six (Q6W) or 12 weeks (Q12W)] in the study
showed the magnitude of response rate from the combination regimen
cohorts was enhanced with increased PD-L1 expression. In these
combination regimen cohorts, the confirmed ORR in patients with
=1% PD-L1 expression was 57% and the confirmed ORR was up to 92%
(n=12/13) in patients with =50% PD-L1 expression. In patients with
<1% PD-L1 expression, the confirmed ORR was 15%. Improved safety
and tolerability was observed with current Opdivo + Yervoy
combination cohorts compared to those previously studied in NSCLC.
-
In May, in conjunction with ASCO, the company announced results from
two studies for Opdivo:
-
CheckMate -057: In this Phase 3 study evaluating Opdivo
versus docetaxel in previously treated metastatic non-squamous
NSCLC patients, Opdivo continued to demonstrate improved
OS, the primary endpoint, at the landmark two-year time point,
with 29% of patients treated with Opdivo alive at two years
versus 16% of those treated with docetaxel. The safety profile of Opdivo
at two years was consistent with previous reports of data from
this study.
-
CheckMate -017: In this Phase 3 study evaluating Opdivo
versus docetaxel in previously treated metastatic squamous NSCLC
patients, Opdivo continued to demonstrate improved OS, the
primary endpoint, at the landmark two-year time point, with 23% of
patients treated with Opdivo alive at two years versus 8%
of those treated with docetaxel. The safety profile of Opdivo at
two years was consistent with previous reports of data from this
study.
Empliciti
-
In May, the company and its partner, AbbVie Inc., announced the EC
approval of Empliciti for the treatment of multiple myeloma as
combination therapy with lenalidomide and dexamethasone in patients
who have received at least one prior therapy. The approval of this
first and only immunostimulatory antibody for multiple myeloma is
based on data from the randomized, open label, Phase 3 ELOQUENT-2
study, which demonstrated that the combination of Empliciti
with lenalidomide and dexamethasone delivered 53% relative improvement
in progression-free survival vs. lenalidomide and dexamethasone alone
at three years.
Orencia/Immunoscience
-
In July, the company announced the commercial launch of the ORENCIA
ClickJectTM Autoinjector, a new self-administered
autoinjector for adults with moderate to severe rheumatoid arthritis
(RA) which was approved by the FDA in June.
-
In July, the company announced the EMA Committee for Medicinal
Products for Human Use (CHMP) recommendation to approve the new
indication for Orencia, in combination with methotrexate (MTX),
for the treatment of highly active and progressive disease in adult
patients with RA who have not received previous MTX treatment. The
opinion is based on the AGREE and AVERT studies. Assuming EU approval,
the new indication would make Orencia the first available
biologic therapy specifically for this indication in the EU.
-
In June, the company announced results from three studies at the
Annual European Congress of Rheumatology (EULAR 2016):
-
In a study exploring patients’ response to treatment for RA based
on their baseline status for two biomarkers of poor prognosis,
anti-cyclic citrullinated peptide (anti-CCP, also known as ACPA)
and rheumatoid factor (RF), data from the Corrona, LLC RA registry
showed that patients who tested positive for anti-CCP or RF were
more likely to have a greater response with Orencia
treatment than patients testing negative for the biomarkers. The
study did not show significant differences in responses between
anti-CCP/RF status in those administered TNF-inhibitors.
-
In a Phase 3 study of juvenile idiopathic arthritis (pJIA),
subcutaneous (SC) Orencia demonstrated equivalent efficacy
and comparable safety to intravenous (IV) Orencia for pJIA
patients. SC Orencia showed efficacy after four months with
greater than 80% of patients achieving an ACR30 response with few
clinically relevant adverse events.
-
In a Phase 1 study, the company’s investigational Bruton’s
Tyrosine Kinase (BTK) inhibitor, BMS-986142, targeted for RA and
other inflammatory diseases, indicated it was well tolerated,
warranting further development of the agent.
BUSINESS DEVELOPMENT UPDATE
-
In July, the company entered into a clinical trial collaboration to
evaluate the safety, tolerability and efficacy of AbbVie’s
investigational antibody drug conjugate Rova-T (rovalpituzumab
tesirine) in combination with Opdivo and Opdivo + Yervoy
regimen as a second-line treatment for extensive- stage small cell
lung cancer (SCLC). The Phase 1/2 clinical program will explore
whether combining these two agents will provide improved and sustained
efficacy and tolerability above the current treatment protocol of
chemotherapy and radiation to SCLC patients.
-
In July, the company entered into a clinical collaboration to evaluate Opdivo
in combination with Janssen Biotech, Inc.’s Live Attenuated
Double-Deleted (LADD) Listerial monocytogenes cancer
immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in
patients with NSCLC. The Phase 2 study will evaluate the tolerability
and clinical activity of the combination of these agents.
-
In July, the company acquired Cormorant Pharmaceuticals, a private,
Stockholm, Sweden-based pharmaceutical company focused on the
development of therapies for cancer and rare diseases. The acquisition
gives Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8
antibody program and the lead candidate HuMax-IL8, a Phase 1/2
monoclonal antibody targeted against interleukin-8 (IL-8) that
represents a potentially complementary Immuno-Oncology mechanism of
action to T-cell directed antibodies and co-stimulatory molecules.
-
In June, the company entered into an exclusive clinical collaboration
agreement to evaluate the safety, tolerability, and preliminary
efficacy of PsiOxus’ enadenotucirev, a systemically administered
oncolytic adenovirus therapeutic, in combination with Opdivo to
treat a range of tumor types in late-stage cancer patients. The
clinical collaboration will support Phase 1 studies to determine
whether combining these two agents can significantly improve
the proportion of patients achieving objective tumor responses, the
extent of tumor shrinkage, and/or the durability of responses.
-
In June, the company and the University of Texas MD Anderson Cancer
Center entered into a new clinical research collaboration to evaluate
strategies for the potential use of Opdivo + Yervoy to
treat early- and advanced-stage lung cancer patients. The
collaboration will help support multiple Phase 1 and 2 clinical trials
testing Opdivo as monotherapy, in combination with Yervoy,
or in regimens with other agents, radiation or surgery in a range of
clinical settings. These studies will also incorporate extensive
translational work including exploration of novel biomarkers to better
differentiate responders from non-responders in lung cancer as well as
preclinical studies of next generation immunotherapeutic agents that
may be used to expand the benefits to larger numbers of patients.
2016 FINANCIAL GUIDANCE
Bristol-Myers Squibb is increasing its 2016 GAAP EPS guidance range from
$2.37 - $2.47 to $2.43 - $2.53. The company is also increasing its
non-GAAP EPS guidance range from $2.50 - $2.60 to $2.55 - $2.65. Both
GAAP and non-GAAP guidance assume current exchange rates. Key revised
2016 non-GAAP line-item guidance assumptions include:
• Research and development expenses increasing in the mid-teen range.
• The effective tax rate is now expected to be 22%.
The financial guidance for 2016 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 2016
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 July 28, 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 877-201-0168 or international
647-788-4901, confirmation code: 91350399. 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 July
28 through 11:59 p.m. EDT on August 11, 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: 91350399.
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.
|
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE THREE MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
Three Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
Key Products
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
Empliciti
|
|
$
|
34
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
33
|
|
|
$
|
—
|
|
|
N/A
|
Erbitux(a)
|
|
—
|
|
|
169
|
|
|
(100
|
)%
|
|
—
|
|
|
165
|
|
|
(100
|
)%
|
Opdivo
|
|
840
|
|
|
122
|
|
|
**
|
|
643
|
|
|
107
|
|
|
**
|
Sprycel
|
|
451
|
|
|
405
|
|
|
11
|
%
|
|
233
|
|
|
205
|
|
|
14
|
%
|
Yervoy
|
|
241
|
|
|
296
|
|
|
(19
|
)%
|
|
179
|
|
|
136
|
|
|
32
|
%
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
|
|
Eliquis
|
|
777
|
|
|
437
|
|
|
78
|
%
|
|
444
|
|
|
243
|
|
|
83
|
%
|
Immunoscience
|
|
|
|
|
|
|
|
|
|
|
|
|
Orencia
|
|
593
|
|
|
461
|
|
|
29
|
%
|
|
401
|
|
|
310
|
|
|
29
|
%
|
Virology
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
299
|
|
|
343
|
|
|
(13
|
)%
|
|
15
|
|
|
37
|
|
|
(59
|
)%
|
Hepatitis C Franchise
|
|
546
|
|
|
479
|
|
|
14
|
%
|
|
294
|
|
|
—
|
|
|
N/A
|
Reyataz Franchise
|
|
247
|
|
|
303
|
|
|
(18
|
)%
|
|
122
|
|
|
157
|
|
|
(22
|
)%
|
Sustiva Franchise
|
|
271
|
|
|
317
|
|
|
(15
|
)%
|
|
227
|
|
|
258
|
|
|
(12
|
)%
|
Neuroscience
|
|
|
|
|
|
|
|
|
|
|
|
|
Abilify(b)
|
|
35
|
|
|
107
|
|
|
(67
|
)%
|
|
—
|
|
|
67
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mature Products and All Other
|
|
537
|
|
|
724
|
|
|
(26
|
)%
|
|
97
|
|
|
152
|
|
|
(36
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
4,871
|
|
|
$
|
4,163
|
|
|
17
|
%
|
|
$
|
2,688
|
|
|
$
|
1,837
|
|
|
46
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
**
|
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 SIX MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
Worldwide Revenues
|
|
U.S. Revenues
|
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
Six Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
Key Products
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
Empliciti
|
|
$
|
62
|
|
|
$
|
—
|
|
|
N/A
|
|
$
|
61
|
|
|
$
|
—
|
|
|
N/A
|
Erbitux
|
|
—
|
|
|
334
|
|
|
(100
|
)%
|
|
—
|
|
|
322
|
|
|
(100
|
)%
|
Opdivo
|
|
1,544
|
|
|
162
|
|
|
**
|
|
1,237
|
|
|
145
|
|
|
**
|
Sprycel
|
|
858
|
|
|
780
|
|
|
10
|
%
|
|
443
|
|
|
386
|
|
|
15
|
%
|
Yervoy
|
|
504
|
|
|
621
|
|
|
(19
|
)%
|
|
378
|
|
|
317
|
|
|
19
|
%
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
|
|
Eliquis
|
|
1,511
|
|
|
792
|
|
|
91
|
%
|
|
912
|
|
|
443
|
|
|
**
|
Immunoscience
|
|
|
|
|
|
|
|
|
|
|
|
|
Orencia
|
|
1,068
|
|
|
861
|
|
|
24
|
%
|
|
722
|
|
|
569
|
|
|
27
|
%
|
Virology
|
|
|
|
|
|
|
|
|
|
|
|
|
Baraclude
|
|
590
|
|
|
683
|
|
|
(14
|
)%
|
|
32
|
|
|
83
|
|
|
(61
|
)%
|
Hepatitis C Franchise
|
|
973
|
|
|
743
|
|
|
31
|
%
|
|
553
|
|
|
—
|
|
|
N/A
|
Reyataz Franchise
|
|
468
|
|
|
597
|
|
|
(22
|
)%
|
|
242
|
|
|
300
|
|
|
(19
|
)%
|
Sustiva Franchise
|
|
544
|
|
|
607
|
|
|
(10
|
)%
|
|
455
|
|
|
492
|
|
|
(8
|
)%
|
Neuroscience
|
|
|
|
|
|
|
|
|
|
|
|
|
Abilify
|
|
68
|
|
|
661
|
|
|
(90
|
)%
|
|
—
|
|
|
575
|
|
|
(100
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mature Products and All Other
|
|
1,072
|
|
|
1,363
|
|
|
(21
|
)%
|
|
190
|
|
|
249
|
|
|
(24
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
9,262
|
|
|
$
|
8,204
|
|
|
13
|
%
|
|
$
|
5,225
|
|
|
$
|
3,881
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars and shares in millions except per share data)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Net product sales
|
|
$
|
4,432
|
|
|
$
|
3,572
|
|
|
$
|
8,396
|
|
|
$
|
6,631
|
|
Alliance and other revenues
|
|
439
|
|
|
591
|
|
|
866
|
|
|
1,573
|
|
Total Revenues
|
|
4,871
|
|
|
4,163
|
|
|
9,262
|
|
|
8,204
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
1,206
|
|
|
1,013
|
|
|
2,258
|
|
|
1,860
|
|
Marketing, selling and administrative
|
|
1,238
|
|
|
1,135
|
|
|
2,306
|
|
|
2,164
|
|
Research and development
|
|
1,266
|
|
|
1,856
|
|
|
2,402
|
|
|
2,872
|
|
Other (income)/expense
|
|
(454
|
)
|
|
107
|
|
|
(974
|
)
|
|
(192
|
)
|
Total Expenses
|
|
3,256
|
|
|
4,111
|
|
|
5,992
|
|
|
6,704
|
|
|
|
|
|
|
|
|
|
|
Earnings Before Income Taxes
|
|
1,615
|
|
|
52
|
|
|
3,270
|
|
|
1,500
|
|
Provision for Income Taxes
|
|
427
|
|
|
162
|
|
|
876
|
|
|
411
|
|
|
|
|
|
|
|
|
|
|
Net Earnings/(Loss)
|
|
1,188
|
|
|
(110
|
)
|
|
2,394
|
|
|
1,089
|
|
Net Earnings Attributable to Noncontrolling Interest
|
|
22
|
|
|
20
|
|
|
33
|
|
|
33
|
|
Net Earnings/(Loss) Attributable to BMS
|
|
$
|
1,166
|
|
|
$
|
(130
|
)
|
|
$
|
2,361
|
|
|
$
|
1,056
|
|
|
|
|
|
|
|
|
|
|
Average Common Shares Outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
1,670
|
|
|
1,667
|
|
|
1,670
|
|
|
1,665
|
|
Diluted
|
|
1,679
|
|
|
1,667
|
|
|
1,679
|
|
|
1,677
|
|
|
|
|
|
|
|
|
|
|
Earnings/(Loss) per Common Share
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.70
|
|
|
$
|
(0.08
|
)
|
|
$
|
1.41
|
|
|
$
|
0.63
|
|
Diluted
|
|
$
|
0.69
|
|
|
$
|
(0.08
|
)
|
|
$
|
1.41
|
|
|
$
|
0.63
|
|
|
|
|
|
|
|
|
|
|
Other (Income)/Expense
|
|
|
|
|
|
|
|
|
Interest expense
|
|
$
|
42
|
|
|
$
|
49
|
|
|
$
|
85
|
|
|
$
|
100
|
|
Investment income
|
|
(25
|
)
|
|
(26
|
)
|
|
(49
|
)
|
|
(56
|
)
|
Provision for restructuring
|
|
18
|
|
|
28
|
|
|
22
|
|
|
40
|
|
Litigation and other settlements
|
|
6
|
|
|
4
|
|
|
49
|
|
|
16
|
|
Equity in net income of affiliates
|
|
(20
|
)
|
|
(22
|
)
|
|
(46
|
)
|
|
(48
|
)
|
Divestiture gains
|
|
(283
|
)
|
|
(8
|
)
|
|
(553
|
)
|
|
(162
|
)
|
Royalties and licensing income
|
|
(167
|
)
|
|
(97
|
)
|
|
(421
|
)
|
|
(195
|
)
|
Transition and other service fees
|
|
(74
|
)
|
|
(27
|
)
|
|
(127
|
)
|
|
(54
|
)
|
Pension charges
|
|
25
|
|
|
36
|
|
|
47
|
|
|
63
|
|
Out-licensed intangible asset impairment
|
|
—
|
|
|
—
|
|
|
15
|
|
|
13
|
|
Equity investment impairment
|
|
45
|
|
|
—
|
|
|
45
|
|
|
—
|
|
Written option adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36
|
)
|
Loss on debt redemption
|
|
—
|
|
|
180
|
|
|
—
|
|
|
180
|
|
Other
|
|
(21
|
)
|
|
(10
|
)
|
|
(41
|
)
|
|
(53
|
)
|
Other (income)/expense
|
|
$
|
(454
|
)
|
|
$
|
107
|
|
|
$
|
(974
|
)
|
|
$
|
(192
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Cost of products sold(a)
|
|
$
|
4
|
|
|
$
|
25
|
|
|
$
|
8
|
|
|
$
|
59
|
|
|
|
|
|
|
|
|
|
|
Marketing, selling and administrative
|
|
—
|
|
|
3
|
|
|
—
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
License and asset acquisition charges
|
|
139
|
|
|
869
|
|
|
264
|
|
|
1,031
|
|
Other
|
|
13
|
|
|
2
|
|
|
26
|
|
|
2
|
|
Research and development
|
|
152
|
|
|
871
|
|
|
290
|
|
|
1,033
|
|
|
|
|
|
|
|
|
|
|
Provision for restructuring
|
|
18
|
|
|
28
|
|
|
22
|
|
|
40
|
|
Divestiture gains
|
|
(277
|
)
|
|
(8
|
)
|
|
(546
|
)
|
|
(160
|
)
|
Pension charges
|
|
25
|
|
|
36
|
|
|
47
|
|
|
63
|
|
Written option adjustment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36
|
)
|
Litigation and other settlements
|
|
—
|
|
|
1
|
|
|
43
|
|
|
15
|
|
Out-licensed intangible asset impairment
|
|
—
|
|
|
—
|
|
|
15
|
|
|
13
|
|
Loss on debt redemption
|
|
—
|
|
|
180
|
|
|
—
|
|
|
180
|
|
Other (income)/expense
|
|
(234
|
)
|
|
237
|
|
|
(419
|
)
|
|
115
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to pretax income
|
|
(78
|
)
|
|
1,136
|
|
|
(121
|
)
|
|
1,211
|
|
|
|
|
|
|
|
|
|
|
Income tax on items above
|
|
76
|
|
|
(116
|
)
|
|
159
|
|
|
(184
|
)
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) to net earnings
|
|
$
|
(2
|
)
|
|
$
|
1,020
|
|
|
$
|
38
|
|
|
$
|
1,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
Specified items in cost of products sold are accelerated
depreciation, asset impairment and other shutdown costs.
|
|
|
|
|
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE
ITEMS
FOR THE THREE MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2016
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
Gross Profit
|
|
|
$
|
3,665
|
|
|
$
|
4
|
|
|
$
|
3,669
|
|
Marketing, selling and administrative
|
|
|
1,238
|
|
|
—
|
|
|
1,238
|
|
Research and development
|
|
|
1,266
|
|
|
(152
|
)
|
|
1,114
|
|
Other (income)/expense
|
|
|
(454
|
)
|
|
234
|
|
|
(220
|
)
|
Effective Tax Rate
|
|
|
26.4
|
%
|
|
(3.6
|
)%
|
|
22.8
|
%
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2015
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
Gross Profit
|
|
|
$
|
3,150
|
|
|
$
|
25
|
|
|
$
|
3,175
|
|
Marketing, selling and administrative
|
|
|
1,135
|
|
|
(3
|
)
|
|
1,132
|
|
Research and development
|
|
|
1,856
|
|
|
(871
|
)
|
|
985
|
|
Other (income)/expense
|
|
|
107
|
|
|
(237
|
)
|
|
(130
|
)
|
Effective Tax Rate
|
|
|
311.5
|
%
|
|
(288.1
|
)%
|
|
23.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
(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 CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE
ITEMS
FOR THE SIX MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2016
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
Gross Profit
|
|
|
$
|
7,004
|
|
|
$
|
8
|
|
|
$
|
7,012
|
|
Marketing, selling and administrative
|
|
|
2,306
|
|
|
—
|
|
|
2,306
|
|
Research and development
|
|
|
2,402
|
|
|
(290
|
)
|
|
2,112
|
|
Other (income)/expense
|
|
|
(974
|
)
|
|
419
|
|
|
(555
|
)
|
Effective Tax Rate
|
|
|
26.8
|
%
|
|
(4.0
|
)%
|
|
22.8
|
%
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2015
|
|
|
GAAP
|
|
Specified
Items(a)
|
|
Non-
GAAP
|
Gross Profit
|
|
|
$
|
6,344
|
|
|
$
|
59
|
|
|
$
|
6,403
|
|
Marketing, selling and administrative
|
|
|
2,164
|
|
|
(4
|
)
|
|
2,160
|
|
Research and development
|
|
|
2,872
|
|
|
(1,033
|
)
|
|
1,839
|
|
Other (income)/expense
|
|
|
(192
|
)
|
|
(115
|
)
|
|
(307
|
)
|
Effective Tax Rate
|
|
|
27.4
|
%
|
|
(5.5
|
)%
|
|
21.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
(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 NON-GAAP EPS TO GAAP EPS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016 AND 2015
(Unaudited, dollars and shares in millions except per share data)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Net Earnings/(Loss) Attributable to BMS used for Diluted EPS
Calculation - GAAP
|
|
$
|
1,166
|
|
|
$
|
(130
|
)
|
|
$
|
2,361
|
|
|
$
|
1,056
|
Less Specified Items*
|
|
(2
|
)
|
|
1,020
|
|
|
38
|
|
|
1,027
|
Net Earnings used for Diluted EPS Calculation – Non-GAAP
|
|
$
|
1,164
|
|
|
$
|
890
|
|
|
$
|
2,399
|
|
|
$
|
2,083
|
|
|
|
|
|
|
|
|
|
Weighted-average Common Shares Outstanding - Diluted - GAAP
|
|
1,679
|
|
|
1,667
|
|
|
1,679
|
|
|
1,677
|
Incremental shares attributable to share-based compensation plans
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
Weighted-average Common Shares Outstanding- Diluted - Non-GAAP
|
|
1,679
|
|
|
1,677
|
|
|
1,679
|
|
|
1,677
|
|
|
|
|
|
|
|
|
|
Diluted Earnings/(Loss) Per Share — GAAP
|
|
$
|
0.69
|
|
|
$
|
(0.08
|
)
|
|
$
|
1.41
|
|
|
$
|
0.63
|
Diluted EPS Attributable to Specified Items
|
|
—
|
|
|
0.61
|
|
|
0.02
|
|
|
0.61
|
Diluted Earnings Per Share — Non-GAAP
|
|
$
|
0.69
|
|
|
$
|
0.53
|
|
|
$
|
1.43
|
|
|
$
|
1.24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Refer to the Specified Items schedule for further details.
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF JUNE 30, 2016 AND MARCH 31, 2016
(Unaudited, dollars in millions)
|
|
|
|
|
|
|
|
June 30, 2016
|
|
March 31, 2016
|
Cash and cash equivalents
|
|
$
|
2,934
|
|
|
$
|
2,644
|
|
Marketable securities - current
|
|
1,717
|
|
|
1,663
|
|
Marketable securities - non-current
|
|
3,281
|
|
|
3,689
|
|
Cash, cash equivalents and marketable securities
|
|
7,932
|
|
|
7,996
|
|
Short-term borrowings
|
|
(155
|
)
|
|
(106
|
)
|
Long-term debt
|
|
(6,581
|
)
|
|
(6,593
|
)
|
Net cash position
|
|
$
|
1,196
|
|
|
$
|
1,297
|
|

View source version on businesswire.com: http://www.businesswire.com/news/home/20160728005221/en/
Source: Bristol-Myers Squibb Company