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 2016, which were highlighted by strong sales for Opdivo,
Eliquis
and our hepatitis C franchise along with significant regulatory
milestones and key data in Immuno-Oncology.

“We had a very good first quarter highlighted by strong sales growth and
significant progress in bringing the promise of Immuno-Oncology across
multiple types of cancer to patients,” said Giovanni
Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “The
launch of Opdivo continues to accelerate with data in new
cancers, additional indications and continued rapid market adoption.
By growing our business and advancing our pipeline, we are successfully
executing our growth strategy.”

FIRST QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted first quarter 2016 revenues of $4.4
  billion, an increase of 9% compared to the same period a year ago.
  Global revenues increased 11% adjusted for foreign exchange impact.
  Excluding Abilify
  and Erbitux,
  global revenues increased 31% or 34% adjusted for foreign exchange
  impact.
• U.S. revenues increased 24% to $2.5 billion in the quarter compared to
  the same period a year ago. International revenues decreased 7%. When
  adjusted for foreign exchange impact, international revenues decreased
  2%.
• Gross margin as a percentage of revenues was 76.0% in the quarter
  compared to 79.0% in the same period a year ago.
• Marketing, selling and administrative expenses increased 4% to $1.1
  billion in the quarter.
• Research and development expenses increased 12% to $1.1 billion in the
  quarter.
• The effective tax rate was 27.1% in the quarter, compared to 17.2% in
  the first quarter last year.
• The company reported net earnings attributable to Bristol-Myers Squibb
  of $1.2 billion, or $0.71 per share, in the quarter compared to net
  earnings of $1.2 billion, or $0.71 per share, a year ago.
• The company reported non-GAAP net earnings attributable to
  Bristol-Myers Squibb of $1.2 billion, or $0.74 per share, in the first
  quarter, compared to $1.2 billion, or $0.71 per share, for the same
  period in 2015. An overview of specified items is discussed under the
  “Use of Non-GAAP Financial Information” section.
• Cash, cash equivalents and marketable securities were $8.0 billion,
  with a net cash position of $1.3 billion, as of March 31, 2016.

FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Global revenues for the first quarter of 2016, compared to the first
quarter of 2015, were driven by Opdivo, which grew by $664
million; Eliquis, which grew by $379 million; Hepatitis C
Franchise, which grew 62%; Orencia,
which grew 19%; and Sprycel,
which grew 9%.

Opdivo

• In April, the U.S. Food and Drug Administration (FDA) granted
  Breakthrough Therapy Designation to Opdivo for the potential
  indication of recurrent or metastatic squamous cell carcinoma of the
  head and neck (SCCHN) after platinum based therapy. The designation is
  based on results of CheckMate -141, a Phase 3, open-label, randomized
  trial evaluating Opdivo versus investigator’s choice of therapy
  in patients with recurrent or metastatic SCCHN with tumor progression
  within six months of platinum therapies in the adjuvant, primary,
  recurrent or metastatic setting. This trial was stopped early in
  January 2016 because an assessment conducted by the independent Data
  Monitoring Committee concluded that the study met its primary endpoint
  of overall survival (OS).
• In April, the FDA accepted for filing and review a Supplemental
  Biologics License Application (sBLA) for Opdivo which seeks to
  expand use to patients with classical Hodgkin lymphoma (cHL) after
  prior therapies. The application included CheckMate -205 data, which
  evaluated Opdivo in cHL patients who have received autologous
  stem cell transplant and brentuximab vedotin.
• In April, the European Commission (EC) approved Opdivo monotherapy
  for locally advanced or metastatic non-small cell lung cancer (NSCLC)
  after prior chemotherapy in adults. The approval expands Opdivo’s existing
  lung cancer indication in previously treated metastatic squamous NSCLC
  to include the non-squamous patient population. Opdivo is the
  only approved PD-1 immune checkpoint inhibitor to demonstrate superior
  OS in two separate Phase 3 trials in previously treated metastatic
  NSCLC, regardless of PD-L1 expression; one trial in squamous NSCLC
  (CheckMate -017) and the other in non-squamous NSCLC (CheckMate -057),
  which were the basis of this approval. The approval allows for the
  expanded marketing of Opdivo in previously treated
  metastatic NSCLC in all 28 Member States of the European Union.
• In April, the EC approved Opdivo monotherapy for advanced
  renal cell carcinoma (RCC) after prior therapy in adults. Opdivo is
  the first and only PD-1 immune checkpoint inhibitor approved in Europe
  to demonstrate an OS benefit versus a standard of care in this patient
  population. The approval is based on the results of the Phase 3 study
  CheckMate -025, which evaluated Opdivo in patients with
  advanced clear-cell RCC who received prior anti-angiogenic therapy
  compared to everolimus. This approval allows for the expanded
  marketing of Opdivo in previously treated advanced RCC in all
  28 Member States of the European Union.
• In April, the Committee for Medicinal Products for Human Use (CHMP) of
  the European Medicines Agency (EMA) recommended the approval of Opdivo
  in combination with Yervoy for
  the treatment of advanced (unresectable or metastatic) melanoma in
  adults. This CHMP recommendation will now be reviewed by the EC, which
  has the authority to approve medicines for the European Union.
• In April, the company announced results from three studies for Opdivo
  and the Opdivo + Yervoy Regimen:
  • CheckMate -141: In this Phase 3 open-label, randomized trial,
    evaluating Opdivo in patients with recurrent or metastatic
    SCCHN after platinum therapy compared to investigator’s choice of
    therapy, Opdivo met the primary endpoints and demonstrated
    statistically significant OS versus three standards of care
    (cetuximab, docetaxel, or methotrexate). In the trial, patients
    treated with Opdivo had a one-year survival rate of 36%
    compared to 16.6% for investigator’s choice, and experienced a 30%
    reduction in the risk of death. Median OS was 7.5 months for Opdivo
    compared to 5.1 months for investigator’s choice. The safety
    profile of Opdivo in CheckMate -141 was consistent with
    prior studies, with no new safety signals identified.
  • CheckMate -069: In this Phase 2 trial, which is the first
    randomized study to evaluate the Opdivo + Yervoy
    combination regimen in patients with previously untreated advanced
    melanoma, the combination regimen demonstrated a two-year OS rate
    of 69% compared to 53% for Yervoy alone in patients with
    BRAF wild-type advanced melanoma. Similar results were observed in
    the overall study population, with an OS rate of 64% at two years
    for the combination regimen compared to 54% for Yervoy
    alone. A change in tumor burden was also seen with the combination
    regimen, with a median change of 70% compared to 5% for Yervoy
    alone. Overall survival was an exploratory endpoint in this trial.
    The safety profile of the Opdivo + Yervoy
    combination regimen in this study was consistent with previously
    reported studies.
  • CA209-003: In this Phase 1 study, evaluating Opdivo
    monotherapy in heavily pretreated advanced melanoma, the company
    reported extended follow-up, including five-year OS rates. This
    data represents the longest survival follow-up of patients who
    received an anti-PD-1 therapy in a clinical trial. At five years, Opdivo
    demonstrated a durable and consistent survival benefit with an
    OS rate of 34%, with an evident plateau in survival at
    approximately 4 years. The safety profile of Opdivo in
    Study 003 was similar to previously reported studies, with no new
    safety signals identified.
• In March, the EMA validated a type II variation application, which
  seeks to extend the current indications for Opdivo to include
  the treatment of patients with cHL after prior therapies. The
  application included data from CheckMate -205, a Phase 2 study which
  evaluated Opdivo in cHL patients who have received autologous
  stem cell transplant and brentuximab vedotin. Validation of the
  application confirms the submission is complete and begins the EMA’s
  centralized review process.

Empliciti

• In January, the company and its partner, AbbVie, Inc., announced the
  CHMP adopted a positive opinion recommending Empliciti, an
  investigational immunostimulatory antibody, be granted approval for
  the treatment of multiple myeloma as combination therapy with Revlimid^®
  and dexamethasone in patients who have received at least one prior
  therapy. The application will now be reviewed by the EC, which has the
  authority to approve medicines for the European Union. The CHMP
  positive opinion is based on data from the Phase 3, open-label
  ELOQUENT-2 study, which evaluated Empliciti in combination
  with lenalidomide and dexamethasone (ERd) versus lenalidomide and
  dexamethasone (Rd) alone.

Daklinza

• In February, the FDA approved Daklinza, an NS5A replication
  complex inhibitor, in combination with sofosbuvir (with or without
  ribavirin) in genotypes 1 and 3. The expanded label includes data in
  three additional challenging-to-treat patient populations: chronic
  hepatitis C virus (HCV) patients with HIV-1 (human immunodeficiency
  virus) coinfection, advanced cirrhosis, or post-liver transplant
  recurrence of HCV. The Daklinza plus sofosbuvir regimen is also
  available for the treatment of chronic HCV genotype 3, and is
  currently the only 12-week, once-daily all-oral treatment option for
  these patients. The approval is based on data evaluating the Daklinza regimens
  from the Phase 3 ALLY-1 and ALLY-2 clinical trials.
• In February, the company announced results from the first completed
  all-oral chronic HCV regimen Phase 3 trial that includes a Chinese
  patient population. In the study, which evaluated Daklinza in
  combination with asunaprevir for 24 weeks in Asian (non-Japanese)
  patients with genotype 1b HCV, 91% of patients from China achieved
  sustained virologic response at post-treatment week 24 (SVR24), which
  rose to 98% of patients without NS5A resistance-associated variants
  (RAVs) at baseline. SVR24 results were similarly high across all
  subgroups with genotype 1b HCV, including those with cirrhosis, and
  patients from Korea and Taiwan. SVR24 rates were also higher in all
  patients without baseline NS5A RAVs, regardless of the presence or
  absence of cirrhosis, and lower in patients with baseline NS5A RAVs.
  Results were presented at the Asian Pacific Association for the Study
  of the Liver Conference in Tokyo.
• In January, the EC approved Daklinza for the treatment of
  chronic HCV in three new patient populations which provides additional
  treatment options for multiple HCV patient populations, including
  difficult-to-treat patients with decompensated cirrhosis. The expanded
  label allows for the use of Daklinza in combination with
  sofosbuvir (with or without ribavirin, depending on the indication and
  HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1
  coinfection, and post-liver transplant recurrence of HCV. The approval
  is based on data from the Phase 3 ALLY-2 and ALLY-2 clinical trials.

Revlimid^® is a trademark of Celgene Corporation.

BUSINESS DEVELOPMENT UPDATE

• In April, the company acquired Padlock Therapeutics, Inc. (Padlock), a
  private, Cambridge, Massachusetts-based biotechnology company
  dedicated to creating new medicines to treat destructive autoimmune
  diseases. The acquisition gives the company full rights to Padlock’s
  Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program
  focused on the development of potentially transformational treatment
  approaches for patients with rheumatoid arthritis. Padlock’s PAD
  discovery program may have additional utility in treating systemic
  lupus erythematosus and other autoimmune diseases.
• In March, the company entered into an agreement with LabCentral, an
  innovative, shared laboratory space designed as a launch pad for
  life-sciences and biotech startup companies, to become a LabCentral
  platinum sponsor. The company can nominate up to two innovative
  life-sciences and biotech startup companies per year to take up
  residence in LabCentral’s Kendall Square facilities.
• In February, the company and its partner, Pfizer Inc., announced a
  collaboration agreement with Portola Pharmaceuticals Inc. to develop
  and commercialize the investigational agent andexanet alfa in Japan.
  Andexanet alfa, which is in Phase 3 clinical development in the U.S.
  and Europe, is designed to reverse the anticoagulant activity of
  Factor Xa inhibitors, including Eliquis. This agreement builds
  on the companies’ existing clinical collaboration to develop andexanet
  alfa in the U.S. and Europe.
• In February, the company entered into a research collaboration
  agreement with the Dana-Farber Cancer Institute as part of the
  Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the
  U.S. As part of the I-O RPM program, the company and the Dana-Farber
  Cancer Institute will conduct a range of early phase clinical studies
  and Bristol-Myers Squibb will support the training of young
  investigators who contribute to the I-O RPM program at Dana-Farber.
• In February, the company completed the previously announced sale of
  its HIV R&D portfolio to ViiV Healthcare. The sale included a number
  of programs at different stages of discovery, preclinical and clinical
  development. The agreements with ViiV Healthcare do not impact the
  company’s marketed HIV medicines, including Reyataz,
  Evotaz,
  Sustiva
  and Atripla.

2016 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2016 GAAP EPS guidance range from
$2.30 – $2.40 to $2.37 – $2.47. The company is also increasing its
non-GAAP EPS guidance range from $2.30 – $2.40 to $2.50 – $2.60. Both
GAAP and non-GAAP guidance assume current exchange rates. Key revised
2016 non-GAAP guidance assumptions include:

• Worldwide revenues increasing in the low-double digit range.
• Marketing, sales and administrative expenses decreasing in the
  low-single digit range.
• Research and development expenses increasing in the low-double digit
  range.

The financial guidance for 2016 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 2016
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; charges
related to licenses and acquisitions of investigational compounds that
have not achieved regulatory approval which are immediately expensed;
pension charges; and significant tax events. 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, 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,
and YouTube.

There will be a conference call on April 28, 2016, at 10:30 a.m. EDT
during which company executives will review financial information and
address inquiries from investors and analysts. Investors and the general
public are invited to listen to a live webcast of the call at http://investor.bms.com
or by dialing in the U.S. toll free 877-201-0168 or international
647-788-4901, confirmation code: 91349055. 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
28 through 11:59 p.m. EDT on May 12, 2016. The replay will also be
available through http://investor.bms.com
or by dialing in the U.S. toll free 855-859-2056 or international
404-537-3406, confirmation code: 91349055.

For more information, contact: Ken Dominski, 609-252-5251, ken.dominski@bms.com,
Communications; Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
or Bill Szablewski, 609-252-5894, william.szablewski@bms.com,
Investor Relations.

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