- Increases Revenues 7% to $4.2
Billion
- Posts Second Quarter GAAP Loss Per
Share of $0.08 and Non-GAAP EPS of $0.53
- Achieves Important Regulatory and
Clinical Milestones for Opdivo (nivolumab)
- Approvals in Europe for Metastatic
Melanoma and Metastatic Squamous Non-Small Cell Lung Cancer
(NSCLC)
- Validation in Europe of Applications
for Opdivo in Non-Squamous NSCLC and in Combination with Yervoy for
Metastatic Melanoma
- Early Stop of CheckMate -025, a
Phase 3 Study Evaluating in Patients with Renal Cell Carcinoma,
After Data Demonstrates Superior Overall Survival
- Presents Significant New Data on
Immuno-Oncology Portfolio at ASCO
- Increases 2015 GAAP EPS Guidance
Range to $1.02 - $1.12 and Non-GAAP EPS Guidance Range to $1.70 -
$1.80
Bristol-Myers Squibb Company (NYSE:BMY) today reported results
for the second quarter of 2015, which were highlighted by strong
global sales, key regulatory and clinical advances for Opdivo and
significant clinical data on the company’s Immuno-Oncology
portfolio presented at the American Society of Clinical Oncology
(ASCO).
“We had a very good quarter, with strong sales
across our portfolio, encouraging results from clinical trials and
important regulatory milestones,” said Giovanni Caforio,
M.D., chief executive officer,
Bristol-Myers Squibb. “I am excited by our progress in
Immuno-Oncology as we continue to advance our leadership position
and transform cancer treatment. As our Immuno-Oncology data
continues to emerge, it is clear we have a tremendous opportunity,
and we are making the right strategic investments to capitalize on
the full potential of our portfolio.”
Second Quarter $
amounts in millions, except per share amounts
2015 2014
Change Total Revenues $4,163 $3,889 7% GAAP
Diluted EPS (0.08) 0.20 ** Non-GAAP Diluted EPS 0.53 0.48 10%
**In excess of +/- 100%
SECOND QUARTER FINANCIAL
RESULTS
- Bristol-Myers Squibb posted second
quarter 2015 revenues of $4.2 billion, an increase of 7% compared
to the same period a year ago. Global revenues increased 16%
adjusted for foreign exchange impact.
- U.S. revenues decreased 3% to $1.8
billion in the quarter compared to the same period a year ago.
International revenues increased 17%.
- Gross margin as a percentage of
revenues was 75.7% in the quarter compared to 74.5% in the same
period a year ago.
- Marketing, selling and administrative
expenses increased 2% to $968 million in the quarter.
- Advertising and product promotion
spending decreased 11% to $167 million in the quarter.
- Research and development expenses
increased 31% to $1.9 billion in the quarter, primarily due to the
acquisition of Flexus Biosciences, Inc.
- The effective tax rate was 311.5% in
the quarter, compared to 25.4% in the second quarter last
year.
- The company reported net loss
attributable to Bristol-Myers Squibb of $130 million, or $0.08 per
share, in the quarter compared to net earnings of $333 million, or
$0.20 per share, a year ago. The results in the current quarter
include an $800 million R&D charge ($0.48 per share) resulting
from the Flexus acquisition, which was not deductible for tax
purposes.
- The company reported non-GAAP net
earnings attributable to Bristol-Myers Squibb of $890 million, or
$0.53 per share, in the second quarter, compared to $798 million,
or $0.48 per share, for the same period in 2014. An overview of
specified items is discussed under the “Use of Non-GAAP Financial
Information” section.
- Cash, cash equivalents and marketable
securities were $10.1 billion, with a net cash position of $2.7
billion, as of June 30, 2015.
SECOND QUARTER PRODUCT AND PIPELINE
UPDATE
Bristol-Myers Squibb’s global sales in the second quarter
included Eliquis, which grew by $266 million, Orencia, which grew
15%, Sprycel, which grew 10%, and Opdivo, which had sales of $122
million. Daklinza and Sunvepra had combined sales of $479 million,
which includes $170 million of previously deferred revenue in
France as part of an early access program before final pricing was
obtained.
Opdivo
- In July, the European Medicines Agency
(EMA) validated two of the company’s type II variation
applications, which seek to extend the current indication for
Opdivo. Validation of the applications confirms that the
submissions are complete and starts the EMA's centralized review
process. In lung cancer, the proposed new indication addresses the
non-squamous, NSCLC population and is based on data from the Phase
3 CheckMate -057 study: Opdivo as monotherapy for the treatment of
locally advanced or metastatic non-squamous NSCLC after prior
chemotherapy in adults. In melanoma, the proposed new indication
aims at extending the use of Opdivo monotherapy in combination with
Yervoy for the treatment of advanced (unresectable or metastatic)
melanoma in adults and is based on data from the Phase 3 CheckMate
-067 study, Phase 2 CheckMate -069 study and the Phase 1b CA209-004
study.
- In July, the European Commission (EC)
approved Nivolumab BMS for the treatment of locally advanced or
metastatic squamous NSCLC after prior chemotherapy. This approval
marks the first major treatment advance in squamous NSCLC in more
than a decade in the European Union (EU). Nivolumab is the first
and only PD-1 immune checkpoint inhibitor to demonstrate overall
survival in previously treated metastatic squamous NSCLC. This
approval allows for the marketing of nivolumab in all 28 Member
States of the EU.
- In July, the company announced that an
open-label, randomized Phase 3 study evaluating Opdivo versus
everolimus in previously treated patients with advanced or
metastatic renal cell carcinoma (CheckMate -025) was stopped early
because an assessment conducted by the independent Data Monitoring
Committee concluded that the study met its endpoint, demonstrating
superior overall survival in patients receiving Opdivo compared to
the control arm. The company looks forward to sharing these data
with health authorities soon.
- In June, the EC approved Opdivo for the
treatment of advanced (unresectable or metastatic) melanoma in
adults, regardless of BRAF status. Opdivo is the first PD-1 immune
checkpoint inhibitor to have received EC approval, which allows
Opdivo to be marketed in all 28 Member States of the EU.
- In June, the U.S. Food and Drug
Administration (FDA) accepted for filing and review the
supplemental Biologics License Application (sBLA) for the
Opdivo+Yervoy regimen in patients with previously untreated
advanced melanoma, the first regulatory milestone for an
immuno-oncology combination regimen in cancer. The FDA also granted
Priority Review for this application, which includes data from
CheckMate -069. The projected FDA action date is September 30,
2015.
- In May, during ASCO in Chicago, the
company announced results from three Phase 3 trials forOpdivo:
- CheckMate -057 – In this study
evaluating previously treated patients with advanced non-squamous
NSCLC, Opdivo became the first PD-1 immune checkpoint inhibitor to
demonstrate superior overall survival versus standard of care
(docetaxel). A 27% reduction in the risk of progression or death –
the primary study endpoint – was reported for Opdivo versus
docetaxel. Opdivo was associated with a doubling of overall median
survival across the continuum of PD-L1 expression, starting at 1%
level of expression. The safety profile of Opdivo in CheckMate -057
was favorable versus docetaxel with grade 3-5 treatment-related
adverse events reported in 10% of patients who were treated with
Opdivo versus 54% in the docetaxel arm.
- CheckMate -017 – In this open-label,
randomized study evaluating Opdivo versus docetaxel in previously
treated patients with advanced squamous NSCLC, Opdivo demonstrated
an overall survival rate of 42% at one year versus 24% for
docetaxel, with a median overall survival of 9.2 months versus 6
months, respectively. Opdivo reduced the risk of death by 41%. The
safety profile of Opdivo in CheckMate -017 was consistent with
prior studies and favorable versus docetaxel. The results were
published in The New England Journal of Medicine (NEJM).
- CheckMate -067 – In this study
evaluating the Opdivo+Yervoy regimen and Opdivo monotherapy versus
Yervoy monotherapy in patients with previously untreated advanced
melanoma, both the Opdivo+Yervoy regimen and Opdivo monotherapy
demonstrated superiority to Yervoy, the current standard of care,
for the co-primary endpoint of progression-free survival (PFS).
Median PFS was 11.5 months for the Opdivo+Yervoy regimen and 6.9
months for Opdivo monotherapy, versus 2.9 months for Yervoy
monotherapy. The Opdivo+Yervoy regimen demonstrated a 58% reduction
in the risk of disease progression versus Yervoy, while Opdivo
monotherapy demonstrated a 43% risk reduction versus Yervoy
monotherapy. The trial is ongoing and patients continue to be
followed for overall survival, a co-primary endpoint.
- Also at ASCO, the company announced
results from an interim analysis of CA209-040, a Phase 1-2
dose-ranging trial evaluating the safety and anti-tumor activity of
Opdivo in previously treated patients with hepatocellular carcinoma
or advanced liver cancer. The estimated survival rate in evaluable
patients receiving Opdivo was 62% at 12 months. Results also show
the safety profile of Opdivo is generally consistent with that
previously reported for Opdivo in other tumor types.
- In April, the FDA accepted for filing
and review an sBLA for Opdivo for the treatment of previously
untreated patients with unresectable or metastatic melanoma. The
FDA also granted Priority Review for this application. The
projected FDA action date is August 27, 2015.
Yervoy
- The company announced today that two
Yervoy Phase 3 trials, Study -095 in metastatic
castration-resistant prostate cancer and Study -156 in newly
diagnosed extensive-stage disease small cell lung cancer, did not
meet their primary endpoints of overall survival versus standard of
care and have been discontinued. No new safety concerns with Yervoy
were identified in either study. The company will complete a full
evaluation of the data and work with investigators on the future
publication of the results.
- In July, the Japanese Ministry of
Health, Labour and Welfare approved Yervoy for first- and
second-line treatment of unresectable malignant melanoma.
Elotuzumab
- In June, during ASCO and the European
Hematology Association (EHA) meeting in Vienna, the company
announced results from an interim analysis of ELOQUENT-2, a Phase
3, randomized, open-label trial that evaluated elotuzumab, an
investigational immunostimulatory antibody, in combination with
lenalidomide and dexamethasone versus lenalidomide and
dexamethasone alone for the treatment of relapsed or refractory
multiple myeloma. The study showed a 30% reduction in the risk of
disease progression or death and a two-year PFS rate of 41% in the
elotuzumab arm versus 27% in the control arm, respectively. Results
also showed minimal incremental adverse events with the addition of
elotuzumab to lenalidomide and dexamethasone. These results
validate elotuzumab’s novel mechanism of action of directly
activating the immune system in patients with relapsed or
refractory multiple myeloma and were published in NEJM.
- In June, at ASCO and EHA, the company
also announced results from a randomized Phase 2 study that
evaluated elotuzumab in combination with bortezomib and
dexamethasone versus bortezomib and dexamethasone alone in patients
with relapsed or refractory multiple myeloma which, consistent with
ELOQUENT-2, demonstrated a 28% reduction in the risk of disease
progression or death.
Eliquis
- In June, at the International Society
on Thrombosis and Haemostasis Congress in Toronto, the company, its
partner Pfizer, and Portola Pharmaceuticals announced full results
from the second part of ANNEXA™-A, a Phase 3, registration-enabling
study evaluating the safety and efficacy of andexanet alfa, an
investigational antidote and FDA-designated breakthrough therapy,
administered as an intravenous bolus followed by a continuous
two-hour infusion to sustain the reversal of anticoagulation
activity of Eliquis in healthy volunteers ages 50-75 years.
Andexanet alfa produced rapid reversal of the anticoagulant effect
of Eliquis – as measured by anti-Factor Xa activity, which was
sustained for the duration of the infusion – and significantly
reduced the level of free unbound Eliquis in the plasma and
restored thrombin generation to normal.
HIV
- In July, the FDA granted Breakthrough
Therapy Designation to the investigational compound BMS-663068, a
first-in-class HIV-1 attachment inhibitor, when used in combination
with other antiretroviral agents for the treatment of HIV-1
infection in heavily treatment-experienced adult patients.
- In July, at the 8th International AIDS
Society Conference on HIV Pathogenesis, Treatment and Prevention in
Vancouver, the company announced additional Phase 2a
proof-of-concept data for BMS-955176, a novel investigational agent
designed to prevent the maturation of HIV-1. The study findings
confirmed the antiretroviral activity of BMS-955176 when
administered with atazanavir (± ritonavir) and support further
development of the second-generation HIV-1 maturation
inhibitor.
Reyataz
- In June, the FDA granted pediatric
exclusivity for Reyataz, providing an additional six-month period
of exclusivity in the U.S.
Daklinza
- In May, the FDA amended a previously
granted Breakthrough Therapy Designation for the investigational
combination of daclatasvir and sofosbuvir for use in hepatitis C
(HCV) patients. The updated Designation reflects data from ALLY-1,
a Phase 3 study of HCV genotype 1 patients with advanced cirrhosis
(Child-Pugh Class B or C) and those who develop genotype 1 HCV
recurrence post-liver transplant. The data were presented at The
International Liver Congress in Vienna, Austria. Daclatasvir is
marketed as Daklinza in Japan and the EU.
Evotaz
- In July, the EC approved Evotaz tablets
in combination with other antiretroviral agents for the treatment
of HIV-1 infected adults without known mutations associated with
resistance to atazanavir. The approval allows for the marketing of
Evotaz in all 28 Member States of the EU.
Nulojix
- In May, during the American Transplant
Congress in Philadelphia, the company presented results from a
seven-year, long-term follow-up of BENEFIT, a prospective,
randomized Phase 3 trial in kidney transplant patients. The study
demonstrated a statistically significant 43% relative risk
reduction of death or graft loss (transplant failure) in patients
receiving the Nulojix FDA-approved dosing regimen over those
receiving a cyclosporine regimen. There also was a statistically
significant survival benefit of 52% relative risk reduction of
death or graft loss at five years post-transplant among patients
receiving the Nulojix regimen. In the long-term follow-up (years
3-7) on BENEFIT participants, the safety profile of the Nulojix
regimen was similar to the cyclosporine regimen.
ANNEXA™ is a trademark of Portola Pharmaceuticals, Inc.
SECOND QUARTER BUSINESS DEVELOPMENT
UPDATE
- In July, the company and The Medical
University of South Carolina announced a translational research
collaboration focused on fibrotic diseases, including scleroderma,
renal fibrosis and idiopathic pulmonary fibrosis. The collaboration
will include studies designed to improve the mechanistic
understanding of fibrosis, explore patient segmentation based on
disease characteristics and/or biomarker approaches and predictors
of disease progression.
2015 FINANCIAL GUIDANCE
Bristol-Myers Squibb is increasing its 2015 GAAP EPS guidance
range from $0.96 - $1.06 to $1.02 - $1.12. The company is also
increasing its non-GAAP EPS guidance range from $1.60 - $1.70 to
$1.70 - $1.80. Both GAAP and non-GAAP guidance assume current
exchange rates and that the R&D tax credit will be extended by
Congress in 2015. Key revised 2015 non-GAAP line-item guidance
assumptions include:
- Worldwide revenues between $15.5 and
$15.9 billion.
- Full-year gross margin as a percentage
of revenues of approximately 76%.
- Advertising and promotion expense
increasing in the high-single-digit range.
- Marketing, sales and administrative
expenses decreasing in the low- to mid-single-digit range.
- Research and development expenses
increasing in the mid-single-digit range.
- An effective tax rate of approximately
19%.
The financial guidance for 2015 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 2015 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 earnings per share
information. These measures are adjusted to exclude certain costs,
expenses, significant gains and losses and other specified items.
Among the items in GAAP measures but excluded for purposes of
determining adjusted earnings and other adjusted measures are:
restructuring and other exit costs; accelerated depreciation
charges; IPRD and asset impairments; charges and recoveries
relating to significant legal proceedings; upfront, milestone and
other payments for in-licensing or acquisition of products that
have not achieved regulatory approval which are immediately
expensed; pension settlement charges; significant tax events and
additional charges related to the Branded Prescription Drug Fee.
This information is intended to enhance an investor’s overall
understanding of the company’s past financial performance and
prospects for the future. Non-GAAP financial measures provide the
company and its investors with an indication of the company’s
baseline performance before items that are considered by the
company not to be reflective of the company’s ongoing results. The
company uses non-GAAP gross profit, non-GAAP marketing, selling and
administrative expense, non-GAAP research and development expense,
and non-GAAP other income and expense measures to set internal
budgets, manage costs, allocate resources, and plan and forecast
future periods. Non-GAAP effective tax rate measures are primarily
used to plan and forecast future periods. Non-GAAP earnings and
earnings per share measures are primary indicators the company uses
as a basis for evaluating company performance, setting incentive
compensation targets, and planning and forecasting of future
periods. This information is not intended to be considered in
isolation or as a substitute for financial measures 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 which
take into account assumptions about the continued extension of the
R&D tax credit, 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, please visit www.bms.com or follow us on Twitter at
http://twitter.com/bmsnews.
There will be a conference call on July 23, 2015, 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 dialing in the
U.S. toll free 877-201-0168 or international 647-788-4901,
confirmation code: 23534784. Materials related to the call will be
available at the same website prior to the conference call.
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE MONTHS ENDED JUNE 30, 2015
AND 2014
(Unaudited, dollars in millions)
Worldwide Revenues U.S. Revenues 2015 2014 %
Change
2015 2014 %
Change
Three Months Ended June 30, Key Products
Virology Baraclude $ 343 $ 369 (7 )% $ 37 $ 84 (56 )%
Hepatitis C Franchise 479 — N/A — — N/A Reyataz Franchise 303 362
(16 )% 157 168 (7 )% Sustiva Franchise 317 361 (12 )% 258 266 (3 )%
Oncology Erbitux(a) 169 186 (9 )% 165 178 (7 )% Opdivo 122 —
N/A 107 — N/A Sprycel 405 368 10 % 205 163 26 % Yervoy 296 321 (8
)% 136 173 (21 )%
Neuroscience Abilify(b) 107 555 (81 )% 67
417 (84 )%
Immunoscience Orencia 461 402 15 % 310 254 22 %
Cardiovascular Eliquis 437 171 ** 243 94 ** Mature
Products and All Other 724 794 (9 )% 152 104 46 % Total
4,163 3,889 7 % 1,837 1,901 (3 )% Total Excluding Diabetes
Alliance 4,099 3,862 6 % 1,834 1,901 (4 )% ** 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
SELECTED PRODUCTS
FOR THE SIX MONTHS ENDED JUNE 30, 2015 AND
2014
(Unaudited, dollars in millions)
Worldwide Revenues U.S. Revenues 2015 2014 %
Change
2015 2014 %
Change
Six Months Ended June 30, Key Products
Virology
Baraclude $ 683 $ 775 (12 )% $ 83 $ 154 (46 )% Hepatitis C
Franchise 743 — N/A — — N/A Reyataz Franchise 597 706 (15 )% 300
344 (13 )% Sustiva Franchise 607 680 (11 )% 492 494 —
Oncology Erbitux 334 355 (6 )% 322 336 (4 )% Opdivo 162 —
N/A 145 — N/A Sprycel 780 710 10 % 386 308 25 % Yervoy 621 592 5 %
317 319 (1 )%
Neuroscience Abilify 661 1,095 (40 )% 575 742
(23 )%
Immunoscience Orencia 861 765 13 % 569 483 18 %
Cardiovascular Eliquis 792 277 ** 443 155 ** Mature
Products and All Other 1,363 1,745 (22 )% 249 331 (25 )%
Total 8,204 7,700 7 % 3,881 3,666 6 % Total Excluding
Diabetes Alliance 8,086 7,494 8 % 3,878 3,552 9 % ** In
excess of 100%
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE AND SIX MONTHS ENDED JUNE
30, 2015 AND 2014
(Unaudited, dollars and shares in millions
except per share data)
Three Months EndedJune 30,
Six Months EndedJune 30,
2015 2014 2015 2014 Net product sales $ 3,572 $ 2,770
$ 6,631 $ 5,577 Alliance and other revenues 591 1,119
1,573 2,123 Total Revenues 4,163 3,889
8,204 7,700 Cost of products sold 1,013 991
1,860 1,959 Marketing, selling and administrative 968 951 1,862
1,908 Advertising and product promotion 167 187 302 350 Research
and development 1,856 1,416 2,872 2,362 Other (income)/expense 107
(104 ) (192 ) (312 ) Total Expenses 4,111 3,441
6,704 6,267 Earnings Before Income
Taxes 52 448 1,500 1,433 Provision for Income Taxes 162 114
411 163 Net Earnings/(Loss) (110 ) 334
1,089 1,270 Net Earnings Attributable to Noncontrolling Interest 20
1 33 — Net Earnings/(Loss) Attributable
to BMS $ (130 ) $ 333 $ 1,056 $ 1,270
Average Common Shares Outstanding: Basic 1,667 1,657 1,665 1,655
Diluted 1,667 1,669 1,677 1,668 Earnings/(Loss) per Common
Share Basic $ (0.08 ) $ 0.20 $ 0.63 $ 0.77 Diluted $ (0.08 ) $ 0.20
$ 0.63 $ 0.76 Other (Income)/Expense Interest expense $ 49 $
46 $ 100 $ 100 Investment income (26 ) (28 ) (56 ) (51 ) Provision
for restructuring 28 16 40 37 Litigation charges/(recoveries) 4 (20
) 16 9 Equity in net income of affiliates (22 ) (33 ) (48 ) (69 )
Out-licensed intangible asset impairment — — 13 — Gain on sale of
product lines, businesses and assets (8 ) 7 (162 ) (252 ) Other
alliance and licensing income (124 ) (144 ) (285 ) (252 ) Pension
curtailments, settlements and special termination benefits 36 45 63
109 Loss on debt redemption 180 — 180 45 Other (10 ) 7 (53 )
12 Other (income)/expense $ 107 $ (104 ) $ (192 ) $
(312 )
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND SIX MONTHS ENDED JUNE
30, 2015 AND 2014
(Unaudited, dollars in millions)
Three Months EndedJune 30,
Six Months EndedJune 30,
2015 2014 2015 2014
Cost of products
sold(a) $ 25 $ 39 $ 59 $ 84
Marketing, selling
and administrative(b) 3 3 4 6 Upfront, milestone
and other payments 869 148 1,031 163 IPRD impairments — 310 — 343
Accelerated depreciation and other shutdown costs 2 —
2 —
Research and development 871 458 1,033 506
Provision for restructuring 28 16 40 37 Gain on sale of
product lines, businesses and assets (8 ) 12 (160 ) (247 ) Pension
curtailments, settlements and special termination benefits 36 45 63
109 Acquisition and alliance related items — 17 (36 ) 33 Litigation
charges/(recoveries) 1 (23 ) 15 2 Out-licensed intangible asset
impairment — — 13 — Loss on debt redemption 180 — 180 45 Upfront,
milestone and other licensing receipts — — — —
Other (income)/expense 237 67 115 (21 )
Increase to pretax income 1,136 567 1,211 575 Income
tax on items above (116 ) (102 ) (184 ) (281 )
Increase to net earnings $ 1,020 $ 465
$ 1,027 $ 294 (a) Specified items in cost of
products sold are accelerated depreciation, asset impairment and
other shutdown costs. (b) Specified items in marketing, selling and
administrative are process standardization implementation costs.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN NON-GAAP LINE
ITEMS TO CERTAIN GAAP LINE ITEMS
FOR THE THREE MONTHS ENDED JUNE 30, 2015
AND 2014
(Unaudited, dollars in millions)
Three Months Ended June 30, 2015 GAAP Specified
Items*
Non
GAAP
Gross Profit $ 3,150 $ 25 $ 3,175 Marketing, selling and
administrative 968 (3 ) 965 Research and development 1,856 (871 )
985 Other (income)/expense 107 (237 ) (130 ) Effective Tax Rate
311.5 % (288.1 )% 23.4 % Three Months Ended June 30, 2014
GAAP Specified
Items*
Non
GAAP
Gross Profit $ 2,898 $ 39 $ 2,937 Marketing, selling and
administrative 951 (3 ) 948 Research and development 1,416 (458 )
958 Other (income)/expense (104 ) (67 ) (171 ) Effective Tax Rate
25.4 % (4.1 )% 21.3 % * 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, 2015 AND
2014
(Unaudited, dollars in millions)
Six Months Ended June 30, 2015 GAAP
SpecifiedItems*
NonGAAP
Gross Profit $ 6,344 $ 59 $ 6,403 Marketing, selling and
administrative 1,862 (4 ) 1,858 Research and development 2,872
(1,033 ) 1,839 Other (income)/expense (192 ) (115 ) (307 )
Effective Tax Rate 27.4 % (5.5 )% 21.9 % Six Months Ended
June 30, 2014 GAAP Specified
Items*
Non
GAAP
Gross Profit $ 5,741 $ 84 $ 5,825 Marketing, selling and
administrative 1,908 (6 ) 1,902 Research and development 2,362 (506
) 1,856 Other (income)/expense (312 ) 21 (291 ) Effective Tax Rate
11.4 % 10.7 % 22.1 % * 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, 2015 AND 2014
(Unaudited, dollars and shares in millions
except per share data)
Three Months EndedJune 30,
Six Months EndedJune 30,
2015 2014 2015 2014 Net Earnings/(Loss) Attributable
to BMS used for Diluted EPS Calculation - GAAP $ (130 ) $ 333 $
1,056 $ 1,270 Less Specified Items* 1,020 465 1,027
294 Net Earnings used for Diluted EPS Calculation – Non-GAAP
$ 890 $ 798 $ 2,083 $ 1,564
Weighted-average Common Shares Outstanding - Diluted - GAAP 1,667
1,669 1,677 1,668 Contingently convertible debt common stock
equivalents — — — — Incremental shares attributable to share-based
compensation plans 10 — — — Weighted-average
Common Shares Outstanding - Diluted - Non-GAAP 1,677 1,669 1,677
1,668 Diluted Earnings/(Loss) Per Share — GAAP $ (0.08 ) $
0.20 $ 0.63 $ 0.76 Diluted EPS Attributable to Specified Items 0.61
0.28 0.61 0.18 Diluted Earnings Per Share —
Non-GAAP $ 0.53 $ 0.48 $ 1.24 $ 0.94 *
Refer to the Specified Items schedule for further details.
BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF JUNE 30, 2015 AND MARCH 31, 2015
(Unaudited, dollars in millions)
June 30, 2015 March 31, 2015 Cash and cash equivalents $
4,199 $ 6,294 Marketable securities - current 1,277 1,313
Marketable securities - long term 4,632 4,279
Cash, cash equivalents and marketable securities 10,108
11,886 Short-term borrowings and current portion of long-term debt
(755 ) (330 ) Long-term debt (6,615 ) (7,127 )
Net cash
position $ 2,738 $ 4,429
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150723005316/en/
Bristol-Myers Squibb CompanyCommunicationsKen Dominski,
609-252-5251ken.dominski@bms.comorJohn Elicker,
609-252-4611john.elicker@bms.comorRanya Dajani,
609-252-5330ranya.dajani@bms.comorInvestor RelationsBill
Szablewski, 609-252-5894william.szablewski@bms.com
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