Bristol-Myers Squibb Reports Third Quarter Financial Results

  • Increases Revenues 4% to $4.1 Billion
  • Posts Third Quarter GAAP EPS of $0.42 and Non-GAAP EPS of $0.39
  • Achieves Significant U.S. Regulatory and Clinical Milestones in
    Immuno-Oncology

    • Opdivo Approved for Previously-Treated Metastatic
      Non-Squamous Non-Small Cell Lung Cancer Regardless of PD-L1
      Expression
    • Opdivo-Yervoy Regimen Approved for Metastatic
      Melanoma
    • Opdivo Granted Breakthrough Therapy Designation
      for Metastatic Renal Cell Carcinoma
  • Refines 2015 GAAP EPS Guidance Range to $1.02 – $1.07 and Increases
    Non-GAAP EPS Guidance Range to $1.85 – $1.90

NEW YORK–(BUSINESS WIRE)–Bristol-Myers
Squibb Company
(NYSE:BMY) today reported results for the third
quarter of 2015, which were highlighted by strong global sales, key
regulatory and clinical milestones in Immuno-Oncology and the completion
of several business development transactions strengthening the company’s
diversified pipeline.

“In the third quarter we advanced our leadership position in
Immuno-Oncology with two accelerated approvals in the U.S. and the
presentation of important new clinical data that demonstrates the
breadth and depth of our development program,” said Giovanni
Caforio, M.D.
, chief executive officer,
Bristol-Myers Squibb. “We delivered strong operational performance
driven by top-line growth, the successful launch of Opdivo
and continuing positive trends for Eliquis.
I remain confident in our strategy and that we are entering our exciting
next chapter in a position of strength.”

         
     

Third Quarter

$ amounts in millions, except per share amounts            

2015

2014

Change

Total Revenues $4,069 $3,921 4%
GAAP Diluted EPS 0.42 0.43 (2)%
Non-GAAP Diluted EPS       0.39       0.45       (13)%
 

THIRD QUARTER FINANCIAL RESULTS

  • Bristol-Myers Squibb posted third quarter 2015 revenues of $4.1
    billion, an increase of 4% compared to the same period a year ago.
    Global revenues increased 11% adjusted for foreign exchange impact.
  • U.S. revenues increased 4% to $2.0 billion in the quarter compared to
    the same period a year ago. International revenues increased 4%, or
    19% adjusted for foreign exchange impact.
  • Gross margin as a percentage of revenues was 73.0% in the quarter
    compared to 74.3% in the same period a year ago.
  • Marketing, selling and administrative expenses decreased 4% to $983
    million in the quarter.
  • Advertising and product promotion spending increased 13% to $193
    million in the quarter.
  • Research and development expenses increased 15% to $1.1 billion in the
    quarter.
  • The effective tax rate was 26.0% in the quarter, compared to 27.4% in
    the third quarter last year.
  • The company reported net earnings attributable to Bristol-Myers Squibb
    of $706 million, or $0.42 per share, in the quarter compared to net
    earnings of $721 million, or $0.43 per share, a year ago.
  • The company reported non-GAAP net earnings attributable to
    Bristol-Myers Squibb of $648 million, or $0.39 per share, in the third
    quarter, compared to $750 million, or $0.45 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 $10.0 billion,
    with a net cash position of $2.8 billion, as of September 30, 2015.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the third quarter included Daklinza
and Sunvepra, which grew by $353 million, Opdivo, which
grew by $304 million, Eliquis, which grew by $250 million, Orencia,
which grew 9%, and Sprycel,
which grew 7%.

Opdivo

  • In October, the U.S. Food and Drug Administration (FDA) approved Opdivo
    for the treatment of previously treated patients with non-squamous
    (NSQ) non-small cell lung cancer (NSCLC) regardless of PD-L1
    expression, which expands upon the current indication for Opdivo
    in patients with previously treated squamous (SQ) NSCLC. Opdivo
    is the only PD-1 inhibitor approved for previously treated metastatic
    SQ and now NSQ NSCLC patients regardless of PD-L1 expressionand
    the only PD-1 inhibitor approved by the FDA to deliver superior
    overall survival compared to docetaxel in previously treated
    metastatic NSCLC. The accelerated approval was based on data from
    CheckMate -057, a Phase 3 study that evaluated the survival of
    patients with NSQ NSCLC who had progressed during or after one prior
    platinum doublet-based chemotherapy regimen.
  • In October, the FDA approved Opdivo in combination with Yervoy
    for the treatment of patients with BRAF V600
    wild-type unresectable or metastatic melanoma.The approval
    marks the first and only FDA approval of a regimen of two
    Immuno-Oncology agents in cancer. The indication was approved under
    accelerated approval based on tumor response rate and durability of
    response data from CheckMate -069. Continued approval for this
    indication may be contingent upon verification and description of
    clinical benefit in confirmatory trials.
  • In September, the FDA granted Breakthrough Therapy Designation to Opdivo
    for the potential indication of advanced or metastatic renal cell
    carcinoma (RCC). This designation is based on results of CheckMate
    -025, a Phase 3 study that evaluated the survival of patients with
    previously treated advanced or metastatic clear-cell RCC versus
    everolimus. The trial was stopped early in July 2015 because an
    assessment conducted by the independent Data Monitoring Committee
    concluded that the study met its primary endpoint of overall survival.
  • In September, the FDA accepted for filing and review a Supplemental
    Biologics License Application (sBLA) for the Opdivo+Yervoy
    regimen to include clinical data from CheckMate -067, a landmark Phase
    3 trial in patients with previously untreated advanced melanoma. If
    approved, this application would expand upon the initial Opdivo+Yervoy regimen,
    which was approved based on tumor response rate and safety data from
    the Phase 2 randomized trial, CheckMate -069. The FDA granted Priority
    Review for this application with a target action date of January 23,
    2016.
  • In September, the company announced results from two Phase 3 clinical
    trials at the 2015 European Cancer Congress:

    • CheckMate -025 – In this study comparing Opdivo to
      everolimus in patients with advanced RCC after prior
      anti-angiogenic treatment, Opdivo demonstrated significant
      overall survival (OS) benefit compared to the standard of care
      with a median OS benefit of 25 months compared to 19.6 months for
      everolimus and clinical benefit regardless of level of PD-L1
      expression. The safety profile shown was consistent with
      previously reported Opdivo trials. The results were
      published in The New England Journal of Medicine (NEJM).
    • CheckMate -057 – In this study evaluating Opdivo vs.
      docetaxel in previously treated patients with advanced NSQ NSCLC, Opdivo continued
      to demonstrate superior OS with an estimated 39% of patients alive
      at 18 months versus 23% for docetaxel, based on a minimum
      follow-up of 17.1 months. Opdivo also continued to
      demonstrate a reduction in the risk of death by 28%. Grade 3-4
      treatment-related adverse events were reported in 10% of patients
      treated with Opdivo versus 54% in the docetaxel arm. The
      results were published in NEJM.
  • In September, the company announced results from multiple clinical
    trials at the World Conference on Lung Cancer in Denver:

    • CheckMate -017 and CheckMate -063 – In these two studies
      evaluating patients with previously treated SQ NSCLC, Opdivo
      demonstrated sustained survival benefit with an estimated 18 month
      OS rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival
      benefit was independent of PD-L1 expression. The safety profile of Opdivo
      was consistent with previously-reported trials, and in
      CheckMate -017, was also favorable compared to docetaxel.
    • CheckMate -012 – In this multi-arm Phase 1b study evaluating Opdivo
      in patients with chemotherapy-naïve advanced NSCLC, new dosing
      schedules of the Opdivo+Yervoy arms confirmed
      objective response rates (ORR) ranging from 13% to 39% depending
      on the administered regimen, and encouraging efficacy with highest
      ORR for the Opdivo 3 mg and Yervoy 1 mg (31% to 39%)
      regimen. Median duration of response was not reached in any of
      these arms with a median follow-up of 6.2 months to 16.6 months,
      and median progression-free survival ranged from 4.9 months to
      10.6 months. Treatment-related serious adverse events reported in
      these cohorts for CheckMate -012 were consistent with other
      previously reported Opdivo+Yervoy cohorts of this trial,
      and the new dosing schedules resulted in less toxicity than
      previously-reported dosing schedules, and an acceptable
      tolerability profile with 10% or fewer subjects discontinuing for
      grade 3-4 adverse events.
  • In August, the company announced that the FDA extended the action date
    for the sBLA for Opdivo for the treatment of patients with
    previously untreated advanced melanoma. The company submitted
    additional data from the Opdivo clinical trial program to
    ensure the broadest data set, irrespective of BRAF status, was
    available for review. This submission constitutes a major amendment
    that will require additional time for review and the new projected FDA
    action date is November 27, 2015.

Yervoy

  • The company announced today that a Yervoy Phase 3 trial, Study
    -104 in subjects with stage IV/recurrent NSCLC, which compared the
    efficacy of Yervoy in combination with paclitaxel and
    carboplatin versus placebo, and versus paclitaxel and carboplatin
    alone did not meet the primary endpoint of overall survival for the Yervoy
    treatment arms and has 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.

Elotuzumab

  • In August, the FDA accepted for priority review the Biologics License
    Application for elotuzumab, an investigational Signaling Lymphocyte
    Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for
    the treatment of multiple myeloma as combination therapy in patients
    who have received one or more prior therapies. Elotuzumab was
    previously granted Breakthrough Therapy Designation. The filing
    acceptance was primarily supported by data from ELOQUENT-2, a Phase 3,
    randomized, open-label study, which evaluated elotuzumab in
    combination with lenalidomide and dexamethasone versus lenalidomide
    and dexamethasone alone. Additionally, the filing was supported by
    data from study CA004-009, a Phase 2, randomized, open-label study
    that evaluated elotuzumab with bortezomib and dexamethasone
    versus bortezomib and dexamethasone alone.
  • In July, the European Medicines Agency (EMA) validated for review the
    Marketing Authorization Application for elotuzumab for the
    treatment of multiple myeloma as combination therapy in adult patients
    who have received one or more prior therapies. The application was
    granted accelerated assessment by the EMA’s Committee for Medicinal
    Products for Human Use. Elotuzumab previously obtained orphan
    drug designation in the European Union (EU). The filing acceptance
    includes data from ELOQUENT-2 and Study CA004-009.

Sprycel

  • In August, the company and its partner Otsuka America Pharmaceutical,
    announced that the FDA approved an update to the Sprycel product
    labeling to include five-year efficacy and safety data in adult
    patients with newly diagnosed Philadelphia chromosome-positive (Ph+)
    chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year
    data in the same patient population who are resistant or intolerant to
    prior therapy, including imatinib.

Daklinza

  • In October, the FDA accepted for priority review three supplemental
    New Drug Applications (sNDAs) for Daklinza for use with
    sofosbuvir with or without ribavirin. The applications are for the
    treatment of patients with chronic hepatitis C (HCV) coinfected with
    human immunodeficiency virus (HIV-1), patients with advanced cirrhosis
    (including decompensated cirrhosis), and for patients with post-liver
    transplant recurrence of HCV. The new sNDAs accepted by the FDA for
    review include data from the ALLY-1 and ALLY-2 clinical trials.
  • In October, the company announced that the National Institute for
    Health and Care Excellence (NICE) has recommended Daklinza
    in England and Wales for the treatment of adult patients with chronic
    HCV infection genotypes 1, 3 and 4.
  • In September, the company announced the European Commission approved
    an updated label for Daklinza for the treatment of chronic HCV
    genotype 3, one of the most difficult-to-treat genotypes. The update
    allows the use of Daklinza in combination with sofosbuvir for
    12 weeks in patients without cirrhosis in all 28 Member States of the
    EU, and marks the first time these patients with genotype 3 HCV have a
    once-daily, all-oral treatment regimen of this shorter duration. The
    approval is based on data from the Phase 3 open-label ALLY-3 clinical
    trial.
  • In July, the FDA approved Daklinza for the treatment of
    patients with chronic HCV genotype 3. The approval marks the first
    time patients in the U.S. have a 12-week, once-daily, all-oral
    treatment option, and is the first approval for Daklinza in the
    U.S. The approval is based on data from the Phase 3 open-label ALLY-3
    clinical trial.

HIV

  • In October, the company announced overall antiviral activity and
    safety results from a three-part Phase 2a proof-of-concept study of
    BMS-955176, a novel investigational therapy designed to prevent the
    maturation of HIV-1. The overall results of the study demonstrate
    BMS-955176’s antiretroviral activity against the HIV-1 virus as both
    monotherapy and in combination with other antiretroviral medicines,
    and across patient subtypes (B, C), including those infected with the
    HIV-1 virus with changes in a critical protein (“Gag polymorphisms”)
    that were not responsive to a previously investigated maturation
    inhibitor. Results were presented at the European AIDS Clinical
    Society’s 15th European AIDS Conference (EACS) in Barcelona.

BUSINESS DEVELOPMENT UPDATE

  • In October, the company announced an exclusive worldwide license and
    collaboration agreement with Five
    Prime Therapeutics, Inc.
    for the development and commercialization
    of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody
    program, including FPA008 which is in Phase 1 development for
    immunology and oncology indications. The agreement replaces the
    existing clinical collaboration agreement between both companies to
    evaluate the safety, tolerability and preliminary efficacy of
    combining Opdivo with FPA008 in six tumor types.
  • In August, the company announced the establishment of the
    Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the
    U.S. The I-O RPM program is a multi-institutional initiative with
    academic-based cancer centers focused on the clinical investigation of
    Immuno-Oncology therapeutics as potential treatment options for
    patients with high risk, poor prognostic cancers, defined as a rare
    population malignancy. As part of the I-O RPM program, Bristol-Myers
    Squibb subsequently announced two collaborations:

    • In August, the company announced an agreement with the Robert H.
      Lurie Comprehensive Cancer Center of Northwestern University (Lurie
      Cancer Center)
      and the Northwestern Medicine Developmental
      Therapeutics Institute (NMDTI)
      whereby the Lurie Cancer Center and NMDTI will conduct a range of
      early phase clinical studies and Bristol-Myers Squibb will fund
      positions within the NMDTI Developmental Therapeutics Fellowship
      program.
    • In September, the company announced an agreement with Moffitt
      Cancer Center
      in which Bristol-Myers Squibb and Moffitt will
      conduct a range of early phase clinical studies, including
      clinical investigations by young investigators to strengthen their
      development as clinical research scientists.
  • In August, the company announced an agreement that grants
    Bristol-Myers Squibb an exclusive right to acquire Promedior,
    a company pioneering the development of targeted therapeutics to treat
    fibrotic diseases, and gain worldwide rights to its lead asset
    PRM-151, a recombinant form of human pentraxin-2 protein in Phase 2
    development for the treatment of idiopathic pulmonary fibrosis (IPF)
    and myelofibrosis (MF). PRM-151 has been granted Fast Track
    designation in the U.S. and Orphan Designation in the U.S. and Europe
    for the treatment of MF, and Orphan Designation in the U.S. and Europe
    for the treatment of IPF.
  • In August, the company announced a research collaboration and license
    agreement with QIMR
    Berghofer Medical Research Institute
    to discover novel therapeutic
    antibodies against an undisclosed Immuno-Oncology target.
  • In July, the company announced a clinical trial collaboration
    agreement with Kyowa
    Hakko Kirin Co., Ltd
    ., to conduct a Phase 1/Phase 2 combination
    study of Opdivo and mogamulizumab, an anti-CCR4 antibody. The
    study, which will be conducted in the U.S., will focus on evaluating
    the safety, tolerability and anti-tumor activity of combining
    mogamulizumab and Opdivo as a potential treatment option for
    patients with advanced or metastatic solid tumors.

2015 FINANCIAL GUIDANCE

Bristol-Myers Squibb is refining its 2015 GAAP EPS guidance range from
$1.02 – $1.12 to $1.02 – $1.07. The company is increasing its non-GAAP
EPS guidance range from $1.70 – $1.80 to $1.85 – $1.90. 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 $16.0 and $16.4 billion.
  • An effective tax rate of approximately 20%.

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.

Compa

Contacts

Bristol-Myers Squibb Company
Communications
Ken Dominski,
609-252-5251
ken.dominski@bms.com
or
John
Elicker, 609-252-4611
john.elicker@bms.com
or
Ranya
Dajani, 609-252-5330
ranya.dajani@bms.com
or
Investor
Relations
Bill Szablewski, 609-252-5894
william.szablewski@bms.com,

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