- 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
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.
Fourth Quarter $ amounts in
millions, except per share amounts
2014 2013
Change Total Revenues $4,258 $4,441 (4)% GAAP
Diluted EPS 0.01 0.44 (98)% Non-GAAP Diluted EPS 0.46 0.51 (10)%
Full Year $ amounts in millions,
except per share amounts 2014
2013 Change Total Revenues
$15,879 $16,385 (3)% GAAP Diluted EPS 1.20 1.54 (22)% Non-GAAP
Diluted EPS 1.85 1.82 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.
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
wild-type 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
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 4-factor 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 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.
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 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.
- 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 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 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 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.
BRISTOL-MYERS SQUIBB COMPANY
SELECTED PRODUCTS
FOR THE THREE MONTHS ENDED DECEMBER 31,
2014 AND 2013
(Unaudited, dollars in millions)
Worldwide Revenues U.S. Revenues 2014 2013
%
Change
2014 2013 %
Change
Three Months Ended December 31, Key
Products
Virology Baraclude $ 341 $ 412 (17)% $ 21 $ 81
(74)% Hepatitis C Franchise 207 — N/A — — N/A Reyataz 318 384 (17)%
176 187 (6)% Sustiva Franchise 407 427 (5)% 340 307 11%
Oncology Erbitux(a) 181 180 1% 171 176 (3)% Opdivo 5 — N/A 1
— N/A Sprycel 398 365 9% 184 157 17% Yervoy 366 260 41% 199 148 34%
Neuroscience Abilify(b) 476 635 (25)% 423 435 (3)%
Immunoscience Orencia 443 397 12% 289 256 13%
Cardiovascular Eliquis 281 71 ** 136 48 ** Diabetes
Alliance 47 455 (90)% (4 ) 322 ** Mature Products and All
Other 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% ** 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 TWELVE MONTHS ENDED DECEMBER 31,
2014 AND 2013
(Unaudited, dollars in millions)
Worldwide Revenues U.S. Revenues 2014 2013
%
Change
2014 2013 %
Change
Twelve Months Ended December 31, Key
Products
Virology Baraclude $ 1,441 $ 1,527 (6)% $ 215 $ 289
(26)% Hepatitis C Franchise 256 — N/A
—
— N/A Reyataz 1,362 1,551 (12)% 689 769 (10)% Sustiva Franchise
1,444 1,614 (11)% 1,118 1,092 2%
Oncology
Erbitux 723 696 4% 682 682
—
Opdivo 6 — N/A 1 — N/A Sprycel 1,493 1,280 17% 671 541 24% Yervoy
1,308 960 36% 709 577 23%
Neuroscience Abilify 2,020 2,289
(12)% 1,572 1,519 3%
Immunoscience Orencia 1,652 1,444 14%
1,064 954 12%
Cardiovascular Eliquis 774 146 ** 404 97 **
Diabetes Alliance 295 1,683 (82)% 110 1,242 (91)%
Mature Products and All Other 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%
** In excess of 100%
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 Twelve Months Ended December 31, December
31, 2014 2013 2014 2013 Net product
sales $ 3,240 $ 3,298 $ 11,660 $ 12,304 Alliance and other revenues
1,018 1,143 4,219 4,081 Total Revenues
4,258 4,441 15,879 16,385 Cost
of products sold 966 1,273 3,932 4,619 Marketing, selling and
administrative 1,151 1,068 4,088 4,084 Advertising and product
promotion 213 254 734 855 Research and development 1,189 957 4,534
3,731 Other (income)/expense 799 20 210 205
Total Expenses 4,318 3,572 13,498
13,494 Earnings Before Income Taxes (60 ) 869 2,381
2,891 Provision for Income Taxes (87 ) 134 352 311
Net Earnings 27 735 2,029 2,580 Net Earnings
Attributable to Noncontrolling Interest 14 9 25
17 Net Earnings Attributable to BMS $ 13 $ 726
$ 2,004 $ 2,563 Earnings per Common
Share Basic $ 0.01 $ 0.44 $ 1.21 $ 1.56 Diluted $ 0.01 $ 0.44 $
1.20 $ 1.54 Average Common Shares Outstanding: Basic 1,660
1,648 1,657 1,644 Diluted 1,673 1,666 1,670 1,662 Other
(Income)/Expense Interest expense $ 53 $ 53 $ 203 $ 199 Investment
income (30 ) (28 ) (101 ) (104 ) Provision for restructuring 91 14
163 226 Litigation charges/(recoveries) 4 25 23 20 Equity in net
income of affiliates (26 ) (38 ) (107 ) (166 ) Out-licensed
intangible asset impairment 11 — 29 — Gain on sale of product
lines, businesses and assets 3 (1 ) (564 ) (2 ) Other alliance and
licensing income (50 ) (28 ) (404 ) (148 ) Pension curtailments,
settlements and special termination benefits 740 27 877 165 Other 3
(4 ) 91 15 Other (income)/expense $ 799
$ 20 $ 210 $ 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 Twelve Months Ended December 31, December
31, 2014 2013 2014 2013 Accelerated
depreciation, asset impairment and other shutdown costs $ 31 $ 36 $
151 $ 36 Amortization of acquired Amylin intangible assets — 137 —
549 Amortization of Amylin alliance proceeds — (71 ) — (273 )
Amortization of Amylin inventory adjustment — — —
14
Cost of products sold 31 102 151 326
Additional year of Branded Prescription Drug Fee — — 96 — Process
standardization implementation costs 1 10 9 16
Marketing, selling and administrative 1 10 105 16
Upfront, milestone and other payments 50 16 278 16 IPRD
impairments — — 343 —
Research and
development 50 16 621 16 Provision for restructuring 91
14 163 226 Gain on sale of product lines, businesses and assets 3 —
(559 ) — Pension curtailments, settlements and special termination
benefits 740 25 877 161 Acquisition and alliance related items(a) —
— 72 (10 ) Litigation charges/(recoveries) 15 — 27 (23 )
Out-licensed intangible asset impairment 11 — 11 — Loss on debt
redemption — — 45 — Upfront, milestone and other licensing receipts
(10 ) — (10 ) (14 )
Other (income)/expense 850 39 626
340
Increase to pretax income 932 167 1,503 698
Income tax on items above (297 ) (51 ) (545 ) (242 )
Specified tax charge(b) 123 — 123 —
Income taxes (174 ) (51 ) (422 ) (242 )
Increase to net earnings
$ 758 $ 116 $ 1,081 $ 456
(a)
Includes $16 million of additional year of
Branded Prescription Drug Fee.
(b)
The 2014 specified tax charge relates to
transfer pricing matters.
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)
Specified Non Three Months Ended December 31, 2014 GAAP
Items* GAAP Gross Profit $ 3,292 $ 31 $ 3,323 Marketing, selling
and administrative 1,151 (1 ) 1,150 Research and development 1,189
(50 ) 1,139 Other (income)/expense 799 (850 ) (51 ) Effective Tax
Rate 145.0 % (135.0 )% 10.0 % Specified Non Three Months
Ended December 31, 2013 GAAP Items* GAAP Gross Profit $ 3,168 $ 102
$ 3,270 Marketing, selling and administrative 1,068 (10 ) 1,058
Research and development 957 (16 ) 941 Other (income)/expense 20
(39 ) (19 ) Effective Tax Rate 15.4 % 2.5 % 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.
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)
Specified Non Twelve Months Ended December 31, 2014 GAAP
Items* GAAP Gross Profit $ 11,947 $ 151 $ 12,098 Marketing, selling
and administrative 4,088 (105 ) 3,983 Research and development
4,534 (621 ) 3,913 Other (income)/expense 210 (626 ) (416 )
Effective Tax Rate 14.8 % 5.1 % 19.9 % Specified Non Twelve
Months Ended December 31, 2013 GAAP Items* GAAP Gross Profit $
11,766 $ 326 $ 12,092 Marketing, selling and administrative 4,084
(16 ) 4,068 Research and development 3,731 (16 ) 3,715 Other
(income)/expense 205 (340 ) (135 ) Effective Tax Rate 10.8 % 4.6 %
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.
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 Twelve Months Ended December 31, December
31, 2014 2013 2014 2013 Net Earnings
Attributable to BMS used for Diluted EPS Calculation - GAAP $ 13 $
726 $ 2,004 $ 2,563 Less Specified Items* 758 116
1,081 456 Net Earnings used for Diluted EPS Calculation –
Non-GAAP $ 771 $ 842 $ 3,085 $ 3,019
Average Common Shares Outstanding – Diluted 1,673 1,666 1,670 1,662
Diluted Earnings Per Share — GAAP $ 0.01 $ 0.44 $ 1.20 $
1.54 Diluted EPS Attributable to Specified Items 0.45 0.07
0.65 0.28 Diluted Earnings Per Share — Non-GAAP $
0.46 $ 0.51 $ 1.85 $ 1.82
* Refer to the Specified Items schedule for further details.
BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF DECEMBER 31, 2014 AND SEPTEMBER 30,
2014
(Unaudited, dollars in millions)
December 31, 2014 September 30, 2014 Cash and cash
equivalents $ 5,571 $ 4,851 Marketable securities - current 1,864
2,370 Marketable securities - long term 4,408 4,328
Cash, cash equivalents and marketable securities 11,843
11,549 Short-term borrowings and current portion of long-term debt
(590 ) (401 ) Long-term debt (7,242 ) (7,267 )
Net cash
position $ 4,011 $ 3,881
Bristol-Myers Squibb CompanyKen Dominski,
609-252-5251ken.dominski@bms.comCommunicationsorJohn Elicker,
609-252-4611john.elicker@bms.comorRanya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.comInvestor Relations
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