Bristol-Myers Squibb Reports Fourth Quarter and Full Year 2014 Financial... Opdivo Demonstrates Superior Overall Survival

Document technical information

Format pdf
Size 360.8 kB
First found Jun 9, 2017

Document content analysis

Language
English
Type
not defined
Concepts
no text concepts found

Persons

Organizations

Places

Transcript

Bristol-Myers Squibb Reports Fourth Quarter and Full Year 2014 Financial Results
•
Achieves Accelerated U.S. Regulatory Approval for Opdivo in Metastatic Melanoma
•
Announces Early Stop of CheckMate -017, a Phase 3 Study of Opdivo, After Data
Demonstrates Superior Overall Survival
•
Posts Fourth Quarter GAAP EPS of $0.01 and Non-GAAP EPS of $0.46
•
Provides 2015 GAAP and Non-GAAP EPS Guidance Range of $1.55 - $1.70
(NEW YORK, January 27, 2015) – Bristol-Myers Squibb Company (NYSE:BMY) today
reported results for the fourth quarter and full year of 2014, which were highlighted by strong global
sales for priority brands and important advances in the company’s immuno-oncology (I-O) portfolio.
The company received accelerated regulatory approval of Opdivo in the U.S., presented encouraging
clinical data for Opdivo across several tumor types from its broad clinical program, and announced
positive results that led to the early stop of Opdivo’s Phase 3 trial in squamous cell non-small cell lung
cancer (NSCLC). In addition, the company presented important clinical data for Eliquis and daclatasvir
and provided financial guidance for 2015.
“We had an excellent fourth quarter to close a strong year financially and operationally, and
made significant progress in our I-O pipeline with the approval of Opdivo in the U.S. for patients with
advanced melanoma,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “Our
performance in 2014 across brands and geographies, continued innovation and productivity in R&D and
investments in business development opportunities reflect the strength and execution of our BioPharma
strategy, and positions us well for 2015,” Andreotti said.
$ amounts in millions, except per share amounts
Total Revenues
GAAP Diluted EPS
Non-GAAP Diluted EPS
$ amounts in millions, except per share amounts
Total Revenues
GAAP Diluted EPS
Non-GAAP Diluted EPS
1
Fourth Quarter
2014
$4,258
0.01
0.46
2013
$4,441
0.44
0.51
Change
(4)%
(98)%
(10)%
Full Year
2014
$15,879
1.20
1.85
2013
$16,385
1.54
1.82
Change
(3)%
(22)%
2%
FOURTH QUARTER FINANCIAL RESULTS
•
Bristol-Myers Squibb posted fourth quarter 2014 revenues of $4.3 billion, a decrease of 4%
compared to the same period a year ago. Excluding the divested Diabetes Alliance, global revenues
increased 6% or 9% adjusted for foreign exchange impact.
•
U.S. revenues decreased 8% to $2.1 billion in the quarter compared to the same period a year ago.
International revenues were flat.
•
Gross margin as a percentage of revenues was 77.3% in the quarter compared to 71.3% in the same
period a year ago. The increase is primarily attributable to the diabetes divestiture.
•
Marketing, selling and administrative expenses increased 8% to $1.2 billion in the quarter.
•
Advertising and product promotion spending decreased 16% to $213 million in the quarter.
•
Research and development expenses increased 24% to $1.2 billion in the quarter, primarily due to
timing.
•
The effective tax rate was 145% in the quarter, compared to 15.4% in the fourth quarter last year.
Income taxes in the current quarter include net tax benefits attributed to specified items and the R&D
credit for the full year 2014.
•
The company reported net earnings attributable to Bristol-Myers Squibb of $13 million, or $0.01 per
share, in the quarter compared to $726 million, or $0.44 per share, a year ago. The results in the
quarter include an after-tax $0.28 per share impact of a non-cash charge resulting from the transfer
of $1.5 billion of U.S. pension obligations to Prudential.
•
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $771 million,
or $0.46 per share, in the fourth quarter, compared to $842 million, or $0.51 per share, for the same
period in 2013. An overview of specified items, including the pension-related charge mentioned
above, is discussed under the “Use of Non-GAAP Financial Information” section.
•
Cash, cash equivalents and marketable securities were $11.8 billion, with a net cash position of $4.0
billion, as of December 31, 2014.
2
FOURTH QUARTER PRODUCT AND PIPELINE UPDATE
Bristol-Myers Squibb’s global sales in the fourth quarter included Eliquis, which grew by $210
million, Yervoy, which grew 41%, Orencia, which grew 12%, Sprycel, which grew 9%, and Daklinza
and Sunvepra, which had combined sales of $207 million.
Opdivo
•
In January, the company announced that an open-label, randomized Phase 3 study evaluating
Opdivo, a human programmed death receptor-1 (PD-1) blocking antibody, versus docetaxel in
previously treated patients with advanced, squamous cell NSCLC 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 will share these data – which for the first time indicate a survival
advantage with an anti-PD-1 immune checkpoint inhibitor in lung cancer – with health authorities.
•
In December, the U.S. Food and Drug Administration (FDA) approved Opdivo injection for
intravenous use. Opdivo is indicated for the treatment of patients with unresectable or metastatic
melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF
inhibitor. Opdivo received accelerated approval for this indication based on tumor response rate and
durability of response. Continued approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials.
•
In December, at the American Society for Hematology (ASH) annual meeting in San Francisco, the
company announced positive results from a cohort of patients in CheckMate -039, its ongoing Phase
1b trial evaluating Opdivo in patients with relapsed or refractory hematological malignancies (n=23).
Results showed high levels of response in patients with relapsed or refractory classical Hodgkin
lymphoma, with an overall response rate of 87% (n=20) and stable disease in 13% (n=3). The
findings were published in The New England Journal of Medicine (NEJM).
•
In November, at the Society for Melanoma Research international congress in Zurich, Switzerland,
the company announced results from CheckMate -066, a Phase 3 randomized, double-blind study,
comparing Opdivo to the chemotherapy dacarbazine in patients with treatment-naïve BRAF wildtype advanced melanoma (n=418). The study met the primary endpoint of overall survival with the
median overall survival not reached for Opdivo vs. 10.8 months for dacarbazine. The one-year
3
survival rate was 73% for Opdivo vs. 42% for dacarbazine and there was a 58% decrease in the risk
of death for patients treated with Opdivo (hazard ratio for death: 0.42, P<0.0001). This survival
advantage was also observed in Opdivo-treated patients who are positive or negative for
programmed death ligand-1 (PD-L1). The findings were published in NEJM.
•
In October, at the Chicago Multidisciplinary Symposium on Thoracic Oncology, the company
announced results from CheckMate -063, a Phase 2 single-arm, open-label study of Opdivo
administered as a single agent in patients with advanced squamous cell NSCLC who have
progressed after at least two prior systemic treatments. Sixty-five percent of patients studied (n=117)
received three or more prior therapies. With approximately 11 months of minimum follow-up, the
objective response rate – the study’s primary endpoint – was 15% (95% CI = 8.7, 22.2) as assessed
by an independent review committee using RECIST 1.1 criteria and the median duration of response
was not reached. The estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and median
overall survival was 8.2 months (95% CI = 6.05, 10.91).
Eliquis
•
In December, at the ASH meeting in San Francisco, the company and its partner, Pfizer, announced
results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that
both Sanquin’s Cofact, a heparin-free formulation, and CSL Behring’s Beriplex® P/N, a formulation
containing heparin, reversed the steady-state pharmacodynamic effects of Eliquis.
•
In November, the company and its partner, Pfizer, along with Portola Pharmaceuticals announced
results from the first part of the Phase 3 ANNEXA™-A studies for Andexanet alfa, Portola’s
investigational anti-Factor Xa agent to reverse the anticoagulant effect of Eliquis. Andexanet alfa
produced rapid and nearly complete reversal (approximately 94%, P<0.0001) of the anticoagulant
effect of Eliquis in healthy volunteers ages 50-75. The data were presented at the American Heart
Association Scientific Sessions in Chicago.
Daclatasvir
•
In November, the FDA issued a Complete Response Letter regarding the New Drug Application
(NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the
treatment of hepatitis C (HCV). The initial daclatasvir NDA focused on its use in combination with
asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir in the U.S. by
4
Bristol-Myers Squibb in October, the FDA is requesting additional data about daclatasvir in
combination with other antiviral agents for the treatment of HCV. Daclatasvir is marketed as
Daklinza in Japan and the European Union.
•
In November, the company announced results from the landmark ALLY trial investigating a
ribavirin-free 12-week regimen of daclatasvir in combination with sofosbuvir in genotype 3 HCV
patients, a patient population that has emerged as one of the most difficult to treat. The data, which
showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve
and 86% of treatment-experienced patients, were presented at the annual meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston.
•
In November, also at AASLD, the company announced data from the UNITY trial program
investigating a 12-week regimen of its all-oral daclatasvir-based TRIO regimen – a fixed-dose
combination of daclatasvir with asunaprevir and beclabuvir – in a broad range of patients with
genotype 1 HCV. In the UNITY-2 study, which evaluated cirrhotic patients, 98% of treatment-naïve
and 93% of treatment-experienced cirrhotic patients receiving TRIO with ribavirin achieved SVR12
and 93% of treatment-naïve and 87% of treatment-experienced cirrhotic patients receiving TRIO
without ribavirin achieved SVR12. In the open-label UNITY-1 study, which evaluated the TRIO
regimen without ribavirin in treatment-naïve and treatment-experienced non-cirrhotic patients for 12
weeks with 24 weeks of follow-up, 91% of patients achieved SVR12 and 92% of treatment-naive
patients and 89% of treatment-experienced patients achieved cure without the use of ribavirin.
Orencia
•
In November, at the American College of Rheumatology annual meeting in Boston, the company
announced results from several new sub-analyses of the Phase 3b AVERT trial investigating the use
of Orencia plus methotrexate (MTX) in biologic and methotrexate-naïve citrullinated protein (CCP)positive early moderate to severe rheumatoid arthritis (RA) patients. The subanalyses showed that
first-line treatment with Orencia plus MTX resulted in patients with early RA achieving
significantly higher rates of stringent measures of remission; reduced the development of anti-CCP
antibodies, an indicator of more severe, persistent, and erosive disease in patients with early rapidly
progressing RA; improved synovitis and osteitis scores at 12 months; and improved joint erosion
scores at both 12 and 18 months, compared to MTX alone.
5
FOURTH QUARTER BUSINESS DEVELOPMENT UPDATE
•
In January, the company announced a clinical trial collaboration agreement with Seattle Genetics to
evaluate the investigational combination of Opdivo with Seattle Genetics’ antibody drug conjugate
Adcetris® (brentuximab vedotin) in two planned Phase 1/2 clinical trials. The first trial will evaluate
the combination of Opdivo and Adcetris® as a potential treatment option for patients with relapsed or
refractory Hodgkin lymphoma, and the second trial will focus on patients with relapsed or refractory
B-cell and T-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma.
•
In January, the company announced a clinical trial collaboration with Lilly to evaluate the safety,
tolerability and preliminary efficacy of Opdivo in combination with Lilly’s galunisertib
(LY2157299), a TGF beta R1 kinase inhibitor. The Phase 1/2 trial will evaluate the investigational
combination of Opdivo and galunisertib as a potential treatment option for patients with advanced
(metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and NSCLC.
•
In January, the company announced a worldwide research collaboration with the California Institute
for Biomedical Research (Calibr) to develop novel small molecule anti-fibrotic therapies, and an
exclusive license agreement that allows Bristol-Myers Squibb to develop, manufacture and
commercialize Calibr’s preclinical compounds resulting from the collaboration.
•
In December, the company and its partner, Ono Pharmaceutical Co., Ltd., along with Kyowa Hakko
Kirin Co., Ltd., announced a clinical trial collaboration agreement to conduct a Phase 1 combination
study of Opdivo and mogamulizumab, an anti-CCR4 antibody. The study, which will be conducted
in Japan, will focus on evaluating the safety, tolerability and anti-tumor activity of combining
Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic
solid tumors.
•
In November, the company and Five Prime Therapeutics, Inc., announced that they have entered into
an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary
efficacy of combining Opdivo with FPA008, Five Prime’s monoclonal antibody that inhibits the
colony stimulating factor-1 receptor. The Phase 1a/1b study will evaluate the combination of Opdivo
and FPA008 as a potential treatment option for patients with NSCLC, melanoma, head and neck
cancer, pancreatic cancer, colorectal cancer and malignant glioma.
•
In November, the company announced plans to construct a state-of-the-art, large-scale biologics
manufacturing facility in Cruiserath, County Dublin, Ireland. The facility will produce multiple
6
therapies for the company’s growing biologics portfolio and significantly increase Bristol-Myers
Squibb’s biologics manufacturing capacity.
•
In November, the company and Galecto Biotech AB announced that the companies, together with
Galecto’s shareholders, have entered into an agreement that provides Bristol-Myers Squibb the
exclusive option to acquire Galecto Biotech AB and gain worldwide rights to its lead asset TD139, a
novel inhaled inhibitor of galectin-3 in Phase 1 development for the treatment of idiopathic
pulmonary fibrosis and other pulmonary fibrotic conditions.
•
In October, the company and Lonza announced a multi-year expansion of their existing biologics
manufacturing agreement. Lonza will produce commercial quantities of a second Bristol-Myers
Squibb biologic medicine at its mammalian manufacturing facility in Portsmouth, New Hampshire.
•
In October, the company and F-star Alpha Ltd. announced that the companies, together with F-star
Alpha’s shareholders, have entered into an agreement that provides Bristol-Myers Squibb the
exclusive option to acquire F-star Alpha, and gain worldwide rights to its lead asset, FS102. FS102
is a novel, Phase 1-ready human epidermal growth factor receptor 2 (HER2)-targeted therapy in
development for the treatment of breast and gastric cancer among a well-defined population of
HER2-positive patients who do not respond or become resistant to current therapies.
Adcetris® is a registered trademark of Seattle Genetics, Inc.
ANNEXA™ is a trademark of Portola Pharmaceuticals, Inc.
Beriplex® P/N is a trademark of CSL Behring GmbH
2015 FINANCIAL GUIDANCE
Bristol-Myers Squibb is setting its 2015 GAAP and non-GAAP EPS guidance range at $1.55 $1.70. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2015 non-GAAP
guidance assumptions include:
•
Worldwide revenues between $14.4 billion and $15.0 billion.
•
Full-year gross margin as a percentage of revenues of approximately 74%.
•
Advertising and promotion expense decreasing in the mid- to high-teen-digit range.
•
Marketing, sales and administrative expenses decreasing in the mid- to high-single-digit
range.
7
•
Research and development expenses decreasing in the low-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 nonGAAP 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 of
products that have not achieved regulatory approval which are immediately expensed; net amortization
of acquired intangible assets and deferred income related to Amylin; 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
8
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 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 January 27, 2015, at 9 a.m. EST 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 647-788-4901, confirmation code: 23518879. Materials related to
the call will be available at the same website prior to the conference call.
For more information, contact: Ken Dominski, 609-252-5251, [email protected],
Communications; John Elicker, 609-252-4611, [email protected], Ranya Dajani, 609-252-5330,
[email protected] or Ryan Asay, 609-252-5020, [email protected], Investor Relations.
9
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars in millions)
Worldwide Revenues
2014
Three Months Ended December 31,
Key Products
Virology
Baraclude
Hepatitis C Franchise
Reyataz
Sustiva Franchise
Oncology
Erbitux(a)
Opdivo
Sprycel
Yervoy
Neuroscience
Abilify(b)
Immunoscience
Orencia
Cardiovascular
Eliquis
$
U.S. Revenues
%
Change
2013
81
—
187
307
(74 )%
N/A
(6 )%
11 %
1%
N/A
9%
41 %
171
1
184
199
176
—
157
148
(3 )%
N/A
17 %
34 %
635
(25 )%
423
435
(3 )%
443
397
12 %
289
256
13 %
281
71
**
136
48
**
47
455
(90 )%
322
**
788
855
(8 )%
146
148
(1 )%
Total
4,258
4,441
(4 )%
2,082
2,265
(8 )%
Total Excluding Diabetes Alliance
4,211
3,986
6%
2,086
1,943
7 %
Mature Products and All Other
**
412
—
384
427
(17 )% $
N/A
(17 )%
(5 )%
181
5
398
366
180
—
365
260
476
%
Change
2013
21 $
—
176
340
Diabetes Alliance
341 $
207
318
407
2014
(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.
10
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars in millions)
Worldwide Revenues
2014
Twelve Months Ended December 31,
Key Products
Virology
Baraclude
Hepatitis C Franchise
Reyataz
Sustiva Franchise
Oncology
Erbitux
Opdivo
Sprycel
Yervoy
Neuroscience
Abilify
Immunoscience
Orencia
Cardiovascular
Eliquis
2014
(26 )%
N/A
(10 )%
2 %
682
1
671
709
682
—
541
577
—
N/A
24 %
23 %
(12 )%
1,572
1,519
3 %
1,444
14 %
1,064
954
12 %
774
146
**
404
97
**
295
1,683
(82 )%
110
1,242
(91 )%
3,105
3,195
(3 )%
481
556
(13 )%
Total
15,879
16,385
(3 )%
7,716
8,318
(7 )%
Total Excluding Diabetes Alliance
15,584
14,702
6 %
7,606
7,076
7 %
Mature Products and All Other
**
1,441 $
256
1,362
1,444
1,527
—
1,551
1,614
(6 )% $
N/A
(12 )%
(11 )%
215 $
—
689
1,118
723
6
1,493
1,308
696
—
1,280
960
4 %
N/A
17 %
36 %
2,020
2,289
1,652
%
Change
2013
289
—
769
1,092
Diabetes Alliance
$
2013
U.S. Revenues
%
Change
In excess of 100%
11
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars and shares in millions except per share data)
Three Months Ended
December 31,
2014
2013
Net product sales
Alliance and other revenues
Total Revenues
$
Cost of products sold
Marketing, selling and administrative
Advertising and product promotion
Research and development
Other (income)/expense
Total Expenses
Earnings Before Income Taxes
Provision for Income Taxes
3,240 $
1,018
4,258
3,298 $ 11,660 $ 12,304
1,143
4,219
4,081
4,441
15,879
16,385
966
1,151
213
1,189
799
4,318
1,273
1,068
254
957
20
3,572
3,932
4,088
734
4,534
210
13,498
4,619
4,084
855
3,731
205
13,494
869
134
2,381
352
2,891
311
735
9
726 $
2,029
25
2,004 $
2,580
17
2,563
0.44 $
0.44 $
1.21 $
1.20 $
1.56
1.54
(60)
(87)
Net Earnings
Net Earnings Attributable to Noncontrolling Interest
Net Earnings Attributable to BMS
$
27
14
13 $
Earnings per Common Share
Basic
Diluted
$
$
0.01 $
0.01 $
Average Common Shares Outstanding:
Basic
Diluted
1,660
1,673
Other (Income)/Expense
Interest expense
Investment income
Provision for restructuring
Litigation charges/(recoveries)
Equity in net income of affiliates
Out-licensed intangible asset impairment
Gain on sale of product lines, businesses and assets
Other alliance and licensing income
Pension curtailments, settlements and special termination benefits
Other
Other (income)/expense
12
$
$
Twelve Months Ended
December 31,
2014
2013
53 $
(30)
91
4
(26)
11
3
(50)
740
3
799 $
1,648
1,666
53 $
(28)
14
25
(38)
—
(1)
(28)
27
(4)
20 $
1,657
1,670
203 $
(101)
163
23
(107)
29
(564)
(404)
877
91
210 $
1,644
1,662
199
(104)
226
20
(166)
—
(2)
(148)
165
15
205
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars in millions)
Three Months Ended
December 31,
2014
2013
Accelerated depreciation, asset impairment and other shutdown costs
Amortization of acquired Amylin intangible assets
Amortization of Amylin alliance proceeds
Amortization of Amylin inventory adjustment
$
Cost of products sold
Additional year of Branded Prescription Drug Fee
Process standardization implementation costs
31 $
—
—
—
31
36 $
137
(71)
—
102
Twelve Months Ended
December 31,
2014
2013
151 $
—
—
—
151
36
549
(273)
14
326
—
1
1
—
10
10
96
9
105
—
16
16
50
—
50
16
—
16
278
343
621
16
—
16
Provision for restructuring
Gain on sale of product lines, businesses and assets
Pension curtailments, settlements and special termination benefits
91
3
740
14
—
25
163
(559)
877
226
—
161
Acquisition and alliance related items(a)
Litigation charges/(recoveries)
Out-licensed intangible asset impairment
Loss on debt redemption
Upfront, milestone and other licensing receipts
Other (income)/expense
—
15
11
—
(10)
850
—
—
—
—
—
39
72
27
11
45
(10)
626
(10)
(23)
—
—
(14)
340
Increase to pretax income
932
167
Income tax on items above
(297)
123
(51)
—
(545)
123
(242)
—
(174)
(51)
(422)
(242)
Marketing, selling and administrative
Upfront, milestone and other payments
IPRD impairments
Research and development
Specified tax charge
Income taxes
(b)
$
Increase to net earnings
(a) Includes $16 million of additional year of Branded Prescription Drug Fee.
(b) The 2014 specified tax charge relates to transfer pricing matters.
13
758 $
1,503
116 $ 1,081 $
698
456
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE ITEMS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars in millions)
Three Months Ended December 31, 2014
Gross Profit
Marketing, selling and administrative
Research and development
Other (income)/expense
Effective Tax Rate
GAAP
$
Three Months Ended December 31, 2013
Gross Profit
Marketing, selling and administrative
Research and development
Other (income)/expense
Effective Tax Rate
3,292 $
1,151
1,189
799
145.0 %
GAAP
$
3,168 $
1,068
957
20
15.4 %
Specified
Items*
Non
GAAP
Specified
Items*
Non
GAAP
31
$
(1)
(50)
(850)
(135.0 )%
102
$
(10)
(16)
(39)
2.5 %
3,323
1,150
1,139
(51)
10.0 %
3,270
1,058
941
(19)
17.9 %
* 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.
14
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE ITEMS
FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars in millions)
Twelve Months Ended December 31, 2014
Gross Profit
Marketing, selling and administrative
Research and development
Other (income)/expense
Effective Tax Rate
GAAP
$
Twelve Months Ended December 31, 2013
Gross Profit
Marketing, selling and administrative
Research and development
Other (income)/expense
Effective Tax Rate
11,947 $
4,088
4,534
210
14.8 %
GAAP
$
11,766 $
4,084
3,731
205
10.8 %
Specified
Items*
Non
GAAP
Specified
Items*
Non
GAAP
151 $
(105)
(621)
(626)
5.1 %
326 $
(16)
(16)
(340)
4.6 %
12,098
3,983
3,913
(416)
19.9 %
12,092
4,068
3,715
(135)
15.4 %
* 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.
15
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF NON-GAAP EPS TO GAAP EPS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2014 AND 2013
(Unaudited, dollars and shares in millions except per share data)
Three Months Ended
December 31,
2014
2013
Net Earnings Attributable to BMS used for Diluted EPS Calculation - GAAP
Less Specified Items*
$
Net Earnings used for Diluted EPS Calculation – Non-GAAP
$
Average Common Shares Outstanding – Diluted
13 $
758
771 $
1,673
Diluted Earnings Per Share — GAAP
Diluted EPS Attributable to Specified Items
$
Diluted Earnings Per Share — Non-GAAP
$
* Refer to the Specified Items schedule for further details.
16
0.01 $
0.45
0.46 $
Twelve Months Ended
December 31,
2014
2013
726 $ 2,004 $ 2,563
116
1,081
456
842 $ 3,085 $ 3,019
1,666
0.44 $
0.07
0.51 $
1,670
1.20 $
0.65
1.85 $
1,662
1.54
0.28
1.82
BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF DECEMBER 31, 2014 AND SEPTEMBER 30, 2014
(Unaudited, dollars in millions)
December 31, 2014
Cash and cash equivalents
Marketable securities - current
Marketable securities - long term
$
Cash, cash equivalents and marketable securities
Short-term borrowings and current portion of long-term debt
Long-term debt
$
Net cash position
17
5,571 $
1,864
4,408
11,843
(590)
(7,242)
4,011 $
September 30, 2014
4,851
2,370
4,328
11,549
(401)
(7,267)
3,881

Similar documents

×

Report this document