- 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
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 % ** In excess of +/- 100%
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 EndedJune 30,
Six Months EndedJune 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 EndedJune 30,
Six Months EndedJune 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 EndedJune 30,
Six Months EndedJune 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/
Bristol-Myers Squibb CompanyCommunications:Ken Dominski,
609-252-5251ken.dominski@bms.comorInvestor Relations:John Elicker,
609-252-4611john.elicker@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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