Bristol-Myers Squibb Reports First Quarter Financial Results

NEW YORK–(BUSINESS WIRE)– Bristol-Myers
Squibb Company (NYSE:BMY) today reported results for the first
quarter of 2017, which were highlighted by strong sales for key products Opdivo
and Eliquis,
regulatory approval for Opdivo in advanced bladder cancer in the
U.S., positive opinions from the Committee for Medicinal Products for
Human Use (CHMP) for advanced bladder and head and neck cancers in
Europe, and strategic transactions in oncology that further strengthened
the company’s pipeline.

“During the first quarter we delivered strong sales and earnings growth,
achieved important regulatory milestones for Opdivo in the U.S.
and Europe and presented important new data across our Immuno-Oncology
and fibrosis portfolios,” said Giovanni
Caforio, M.D., chief executive officer, Bristol-Myers Squibb.
“Building on this strong start to the year, we will continue to drive
commercial performance in the short-term while advancing important
opportunities to broaden our approach in Immuno-Oncology and progressing
our early specialty portfolio.”

FIRST QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted first quarter 2017 revenues of $4.9
  billion, an increase of 12% compared to the same period a year ago.
  Revenues increased 13% when adjusted for foreign exchange impact.
• U.S. revenues increased 8% to $2.7 billion in the quarter compared to
  the same period a year ago. International revenues increased 18%. When
  adjusted for foreign exchange impact, international revenues increased
  20%.
• Gross margin as a percentage of revenue decreased from 76.0% to 74.5%
  in the quarter primarily due to product mix.
• Marketing, selling and administrative expenses increased 1% to $1.1
  billion in the quarter.
• Research and development expenses increased 13% to $1.3 billion in the
  quarter.
• The effective tax rate was 21.9% in the quarter, compared to 27.1% in
  the first quarter last year.
• The company reported net earnings attributable to Bristol-Myers Squibb
  of $1.6 billion, or $0.94 per share, in the first quarter compared to
  net earnings of $1.2 billion, or $0.71 per share, for the same period
  in 2016. The results for the first quarter of 2017 included
  Bristol-Myers Squibb’s share of a patent-infringement litigation
  settlement related to Merck’s PD-1 antibody Keytruda^® that
  contributed $0.18 per share.
• The company reported non-GAAP net earnings attributable to
  Bristol-Myers Squibb of $1.4 billion, or $0.84 per share, in the first
  quarter, compared to $1.2 billion, or $0.74 per share, for the same
  period in 2016. An overview of specified items is discussed under the
  “Use of Non-GAAP Financial Information” section.
• Cash, cash equivalents and marketable securities were $8.8 billion,
  with a net cash position of $360 million, as of March 31, 2017.

FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

The increase in global revenues for the first quarter of 2017, compared
to the first quarter of 2016, was driven by:

Opdivo

Regulatory

• In April, the company announced the CHMP recommended the approval of Opdivo
  for the treatment of patients with locally advanced unresectable or
  metastatic urothelial carcinoma (mUC) in adults after failure of prior
  platinum-containing chemotherapy. The CHMP recommendation will be
  reviewed by the European Commission (EC), which has the authority to
  approve medicines for the European Union (EU).
• In April, the company announced the U.S. Food and Drug Administration
  (FDA) accepted a supplemental Biologics License Application seeking to
  extend the use of Opdivo to patients with mismatch repair
  deficient or microsatellite instability high metastatic colorectal
  cancer after prior fluoropyrimidine-, oxaliplatin- and
  irinotecan-based chemotherapy. The FDA granted the application
  priority review and the FDA action date is August 2, 2017.
• In April, the FDA approved an updated indication for Opdivo for
  the treatment of adult patients with Classical Hodgkin lymphoma that
  have relapsed or progressed after autologous hematopoietic stem cell
  transplantation (HSCT) and brentuximab vedotin, or three or more lines
  of systemic therapy that includes autologous HSCT. This indication is
  approved under accelerated approval based on overall response rate.
  Continued approval for this indication may be contingent upon
  verification and description of clinical benefit in confirmatory
  trials.
• In March, the company announced the CHMP recommended the approval of Opdivo
  as monotherapy for the treatment of squamous cell cancer of the head
  and neck in adults progressing on or after platinum-based therapy. The
  CHMP recommendation will be reviewed by the EC.
• In March, the company and its partner Ono Pharmaceutical Co. announced
  the approval of Opdivo as monotherapy for the treatment of
  recurrent or metastatic head and neck cancer in Japan.
• In February, the company announced the FDA provided accelerated
  approval for Opdivo for the treatment of patients with locally
  advanced or metastatic urothelial carcinoma who have disease
  progression during or following platinum-containing chemotherapy or
  have disease progression within 12 months of neoadjuvant or adjuvant
  treatment with platinum-containing chemotherapy.

Clinical

• In April, at the American Association for Cancer Research (AACR)
  Annual Meeting, the company announced new data and analysis from
  studies evaluating Opdivo and the Opdivo + Yervoy
  regimen:
  • First overall survival results from CheckMate -067, a Phase 3
    trial of Opdivo and the Opdivo + Yervoy
    regimen versus Yervoy alone in patients with previously
    untreated advanced melanoma. More detail of the study results is
    included in the original press release (link).
  • The first report of five-year overall survival data from the Phase
    1 dose-ranging study CA209-003 evaluating Opdivo in
    patients with previously treated advanced non-small cell lung
    cancer. More detail of the study results is included in the
    original press release (link).
• In April, the company announced CheckMate -143, a randomized Phase 3
  clinical trial evaluating the efficacy and safety of Opdivo in
  patients with first recurrence of glioblastoma multiforme did not meet
  its primary endpoint of improved overall survival over bevacizumab
  monotherapy.

Sprycel

• In February, the company announced the European Patent Office (EPO)
  upheld a decision finding European Patent No. 1169038 (the ‘038
  patent), the Composition of Matter patent covering dasatinib, the
  active ingredient in Sprycel, to be invalid. The decision does
  not impact patents outside of the EU or other Sprycel-related
  patents. Additionally in February, the EPO Board of Appeal reversed
  and remanded an invalidity decision on European Patent No. 1610780 and
  its claim to the use of dasatinib to treat chronic myeloid leukemia
  (CML), which the EPO’s Opposition Division had revoked in October
  2012. The company intends to take appropriate legal actions to protect Sprycel.

Eliquis

• In March, at the American College of Cardiology’s (ACC) Annual
  Scientific Session, the company and its partner Pfizer Inc. announced
  findings from a real-world data analysis of the U.S. Medicare database
  comparing the risk of stroke or systemic embolism and rate of major
  bleeding among patients with non-valvular atrial fibrillation who were
  treated with direct oral anticoagulants Eliquis, dabigatran or
  rivaroxaban versus warfarin. More detail of the analysis is
  included in the original press release (link).

Fibrosis

• In April, at EASL: The International Liver Congress, the company
  announced data from a Phase 2 study of BMS-986036, an investigational
  pegylated analogue of human fibroblast growth factor 21 (FGF21), a key
  regulator of metabolism, in patients with biopsy-confirmed
  non-alcoholic steatohepatitis (NASH ) (F1-F3). The study achieved its
  primary endpoint of significant reduction in liver fat versus placebo,
  and also showed improvement in markers of liver injury and fibrosis.

FIRST QUARTER BUSINESS DEVELOPMENT UPDATE

• In April, the company and Transgene announced a clinical research
  collaboration to evaluate the safety, tolerability and efficacy of
  Transgene’s investigational therapeutic vaccine TG4010 in combination
  with Opdivo + standard chemotherapy (CT) as a first-line
  treatment for advanced non-squamous non-small cell lung cancer (NSCLC)
  in patients whose tumors have low or undetectable levels of PD-L1.
• In April, the company and Apexigen, Inc. announced a clinical trial
  collaboration to evaluate the safety, tolerability and preliminary
  efficacy of Apexigen’s APX005M with Opdivo in patients with
  second-line metastatic NSCLC who have failed prior chemotherapy, and
  in metastatic melanoma patients who have failed prior Immuno-Oncology
  (I-O) therapy.
• In April, the company and Nordic Bioscience announced a collaboration
  to develop biomarker technology to potentially aid in the diagnosis
  and monitoring of fibrotic diseases including NASH.
• In April, the company announced it entered into two separate
  agreements to outlicense BMS-986168, an anti-eTau compound in
  development for Progressive Supranuclear Palsy, to Biogen, and
  BMS-986089, an anti-myostatin adnectin in development for Duchenne
  Muscular Dystrophy, to Roche. The company will receive upfront
  payments of $300 million from Biogen and $170 million from Roche,
  along with potential milestone payments and royalties from each
  company.
• In April, the company and Incyte Corporation announced an agreement to
  advance their clinical development program evaluating the combination
  of epacadostat, Incyte’s investigational oral selective IDO1 enzyme
  inhibitor, with Opdivo into Phase 3 registrational studies in
  first-line NSCLC across the spectrum of PD-L1 expression and
  first-line head and neck cancer. Additionally, the companies are
  expanding the ECHO-204 Phase 1/2 study, established under a
  collaboration between the companies in 2014, to include
  anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts.
• In March, the company and Foundation Medicine announced a
  collaboration to leverage Foundation Medicine’s comprehensive genomic
  profiling and molecular information solutions to identify predictive
  biomarkers such as Tumor Mutational Burden and Microsatellite
  Instability in patients enrolled across clinical trials investigating
  Bristol-Myers Squibb’s cancer immunotherapies.
• In March, the company, the Parker Institute for Cancer Immunotherapy
  and the Cancer Research Institute (CRI) announced a multi-year
  collaboration agreement to coordinate and rapidly initiate clinical
  I-O studies across the Parker Institute and CRI networks.
• In March, the company and CytomX Therapeutics, Inc. announced an
  expansion of their collaboration to discover novel therapies against
  multiple I-O targets using CytomX’s proprietary Probody^®
  Platform, expanding the number of targets from four to twelve.
• In March, the company announced an equity investment and plans for a
  research collaboration with GRAIL Inc. that grants the company early
  access to GRAIL’s comprehensive clinical trial databases that may help
  improve understanding of tumor genomics. Additionally, Bristol-Myers
  Squibb will utilize GRAIL’s analytics tools to inform research,
  advance diagnostics and improve patient outcomes.
• In February, the company and Exelixis, Inc. announced a clinical
  development collaboration to evaluate Cabometyx^®
  (cabozantinib), Exelixis’ small molecule inhibitor of receptor
  tyrosine kinases, with Opdivo, either alone or in combination
  with Yervoy. The agreement is expected to include a Phase 3
  pivotal trial in first-line renal cell carcinoma, with additional
  trials planned in bladder cancer, hepatocellular carcinoma (HCC), and
  potentially other tumor types.
• In February, the company announced an expansion of the five-year old
  International Immuno-Oncology Network (II-ON) with the addition of
  Columbia University Medical Center and Peter MacCallum Cancer Centre
  (Peter Mac). II-ON is a global peer-to-peer collaboration between
  Bristol-Myers Squibb and academia that aims to advance I-O science and
  translational medicine to improve patient outcomes.

SHARE REPURCHASE

In February, the company executed accelerated share repurchase (ASR)
agreements to repurchase, in aggregate, $2 billion of the company’s
common stock. The ASR was funded through a combination of debt and cash
and is part of the company’s existing share repurchase authorization.
Approximately 80 percent of the shares to be repurchased under the
transaction were received by the company on February 28, 2017 and the
company anticipates that all repurchases under the ASR will be completed
by the end of the second quarter of 2017.

The decision reflects the company’s strong financial position and its
balanced approach to capital allocation, including a commitment to its
dividend and a disciplined approach to business development.

2017 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2017 GAAP EPS guidance range from
$2.47- $2.67 to $2.72 – $2.87 and is increasing its non-GAAP EPS
guidance range from $2.70 – $2.90 to $2.85 – $3.00. Both GAAP and
non-GAAP guidance assume current exchange rates. Key revised 2017 GAAP
and non-GAAP line-item guidance assumptions are:

• Worldwide revenues increasing in the mid-single digits.
• Research and development expenses increasing in the high-teens digit
  range for GAAP and increasing in the low-double digits range for
  non-GAAP.
• An effective tax rate of approximately 22% for GAAP with non-GAAP
  remaining at approximately 21%.

The financial guidance 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 guidance also
excludes other specified items as discussed under “Use of Non-GAAP
Financial Information.” Details reconciling GAAP amounts to non-GAAP
amounts, with non-GAAP reflecting specified items are provided in
supplemental materials attached to this press release and available on
the company’s website.

Keytruda^® is a trademark of Merck & Co., Inc.
Probody^®
Platform is a trademark of CytomX Therapeutics, Inc.
Cabometyx^®
is a trademark of Exelixis, Inc.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including
non-GAAP earnings and related EPS information, that are adjusted to
exclude certain costs, expenses, gains and losses and other specified
items that are evaluated on an individual basis. These items are
adjusted after considering their quantitative and qualitative aspects
and typically have one or more of the following characteristics, such as
being highly variable, difficult to project, unusual in nature,
significant to the results of a particular period or not indicative of
future operating results. Similar charges or gains were recognized in
prior periods and will likely reoccur in future periods including
restructuring costs, accelerated depreciation and impairment of
property, plant and equipment and intangible assets, R&D charges in
connection with the acquisition or licensing of third party intellectual
property rights, divestiture gains or losses, upfront payments from out
licensed assets, pension charges, legal and other contractual
settlements and debt redemption gains or losses, among other items.
Deferred and current income taxes attributed to these items are also
adjusted for considering their individual impact to the overall tax
expense, deductibility and jurisdictional tax rates. Non-GAAP
information is intended to portray the results of our baseline
performance, supplement or enhance management, analysts and investors
overall understanding of our underlying financial performance and
facilitate comparisons among current, past and future periods. For
example, non-GAAP earnings and EPS information is an indication of our
baseline performance before items that are considered by us to not be
reflective of our ongoing results. In addition, this information is
among the primary indicators we use as a basis for evaluating
performance, allocating resources, setting incentive compensation
targets and planning and forecasting for future periods. This
information is not intended to be considered in isolation or as a
substitute for net earnings or diluted EPS prepared in accordance with
GAAP.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, statements relating to goals, plans and
projections regarding the company’s financial position, results of
operations, market position, product development and business strategy.
These statements may be identified by the fact that they use words such
as « anticipate », « estimates », « should », « expect », « guidance », « project »,
« intend », « plan », « believe » and other words and terms of similar meaning
in connection with any discussion of future operating or financial
performance. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties, including
factors that could delay, divert or change any of them, and could cause
actual outcomes and results to differ materially from current
expectations. These factors include, among other things, effects of the
continuing implementation of governmental laws and regulations related
to Medicare, Medicaid, Medicaid managed care organizations and entities
under the Public Health Service 340B program, pharmaceutical rebates and
reimbursement, market factors, competitive product development and
approvals, pricing controls and pressures (including changes in rules
and practices of managed care groups and institutional and governmental
purchasers), economic conditions such as interest rate and currency
exchange rate fluctuations, judicial decisions, claims and concerns that
may arise regarding the safety and efficacy of in-line products and
product candidates, changes to wholesaler inventory levels, variability
in data provided by third parties, changes in, and interpretation of,
governmental regulations and legislation affecting domestic or foreign
operations, including tax obligations, changes to business or tax
planning strategies, difficulties and delays in product development,
manufacturing or sales including any potential future recalls, patent
positions and the ultimate outcome of any litigation matter. These
factors also include the company’s ability to execute successfully its
strategic plans, including its business development strategy, the
expiration of patents or data protection on certain products, including
assumptions about the company’s ability to retain patent exclusivity of
certain products, and the impact and result of governmental
investigations. There can be no guarantees with respect to pipeline
products that future clinical studies will support the data described in
this release, that the compounds will receive necessary regulatory
approvals, or that they will prove to be commercially successful; nor
are there guarantees that regulatory approvals will be sought, or sought
within currently expected timeframes, or that contractual milestones
will be achieved. For further details and a discussion of these and
other risks and uncertainties, see the company’s periodic reports,
including the annual report on Form 10-K, quarterly reports on Form 10-Q
and current reports on Form 8-K, filed with or furnished to the
Securities and Exchange Commission. The company undertakes no obligation
to publicly update any forward-looking statement, whether as a result of
new information, future events or otherwise.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter,
YouTube
and Facebook.

There will be a conference call on April 27, 2017 at 10:30 a.m. EDT
during which company executives will review financial information and
address inquiries from investors and analysts. Investors and the general
public are invited to listen to a live webcast of the call at http://investor.bms.com
or by calling the U.S. toll free 855-303-0072 or international
913-312-0976, confirmation code: 500711. Materials related to the call
will be available at the same website prior to the conference call. A
replay of the call will be available beginning at 1:30 p.m. EDT on April
27, 2017 through 1:30 p.m. EDT on May 11, 2017. The replay will also be
available through http://investor.bms.com
or by calling the U.S. toll free 888-203-1112 or international
719-457-0820, confirmation code: 6160500.

Image may be NSFW.
Clik here to view.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170427005341/en/