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Bristol-Myers Squibb Reports First Quarter Financial Results

The following excerpt is from the company's SEC filing.

Increases First Quarter Revenues 9% to $4.4 Billion

Posts First Quarter GAAP EPS of $0.71 and Non-GAAP EPS of $0.74

Achieves Significant European Regulatory Milestones in Immuno-Oncology

Opdivo

Approved for Previously Treated Advanced Renal Cell Carcinoma

Expanded Use of

to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Positive Advisory Opinions for

Yervoy

Regimen and

Empliciti

Validation of Application for

in Classical Hodgkin Lymphoma

Announces

Granted Breakthrough Therapy D esignation for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck, and Priority Review in Classical Hodgkin Lymphoma from the FDA

Presents Significant New Data on Immuno-Oncology Portfolio at AACR

Increases 2016 GAAP EPS Guidance Range to $2.37 - $2.47 and Non-GAAP EPS Guidance Range to $2.50 - $2.60

Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the first quarter of 2016, which were highlighted by strong sales for

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

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.”

$ amounts in millions, except per share amounts

Change

Total Revenues

GAAP Diluted EPS

Non-GAAP Diluted EPS

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

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

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%.

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

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

which seeks to expand use to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated

in cHL patients who have received autologous stem cell transplant and brentuximab vedotin.

In April, the European Commission (EC) approved

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.

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

in previously treated metastatic NSCLC in all 28 Member States of the European Union.

In April, the EC approved

monotherapy for advanced renal cell carcinoma (RCC) after prior therapy in adults.

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

in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus. This approval allows for the expanded marketing of

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

in combination with

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 + Yervoy

Regimen:

CheckMate -141: In this Phase 3 open-label, randomized trial, evaluating

in patients with recurrent or metastatic SCCHN after platinum therapy compared to investigator’s choice of therapy,

met the primary endpoints and demonstrated statistically significant OS versus three standards of care (cetuximab, docetaxel, or methotrexate). In the trial, patients treated with

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

compared to 5.1 months for investigator’s choice. The safety profile of

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

combination regimen in patients with previously untreated advanced melanoma, the combination regimen demonstrated a two-year OS rate of 69% compared to 53% for

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

alone. A change in tumor burden was also seen with the combination regimen, with a median change of 70% compared to 5% for

alone. Overall survival was an exploratory endpoint in this trial. The safety profile of the

combination regimen in this study was consistent with previously reported studies.

CA209-003: In this Phase 1 study, evaluating

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,

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

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

to include the treatment of patients with cHL after prior therapies. The application included data from CheckMate -205, a Phase 2 study which evaluated

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.

In January, the company and its partner, AbbVie, Inc., announced the CHMP adopted a positive opinion recommending

, 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

in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.

Daklinza

In February, the FDA approved

, 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

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

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

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

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

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.

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 announced 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

. 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

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.

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.

BRISTOL-MYERS SQUIBB COMPANY

PRODUCT REVENUE

FOR THE THREE MONTHS ENDED

MARCH 31, 2016

(Unaudited, dollars in millions)

Worldwide Revenues

U.S. Revenues

Three Months Ended March 31,

Key Products

Cardiovascular

Immunoscience

Orencia

Virology

Baraclude

Reyataz Franchise

Sustiva Franchise

Neuroscience

Mature Products and All Other

In excess of +/- 100%

is a trademark of ImClone LLC. ImClone LLC is a wholly-owned subsidiary of Eli Lilly and Company.

is a trademark of Otsuka Pharmaceutical Co., Ltd.

CONSOLIDATED STATEMENTS OF EARNINGS

(Unaudited, dollars and shares in millions except per share data)

Net product sales

Alliance and other revenues

Cost of products sold

Other (income)/expense

Total Expenses

Earnings Before Income Taxes

Provision for Income Taxes

Net Earnings

Net Earnings Attributable to Noncontrolling Interest

Net Earnings Attributable to BMS

Average Common Shares Outstanding:

Earnings per Common Share

Other (Income)/Expense

Interest expense

Investment income

Provision for restructuring

Litigation and other settlements

Equity in net income of affiliates

Out-licensed intangible asset impairment

Divestiture gains

Royalties and licensing income

Transition and other service fees

Pension charges

Written option adjustment

SPECIFIED ITEMS

License and asset acquisition charges

Increase/(decrease) to pretax income

Income tax on items above

Increase to net earnings

Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs.

BRISTOL-MYERS SQUIBB COMPANY

RECONCILIATION OF CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE ITEMS

Three Months Ended March 31, 2016

Gross Profit

Effective Tax Rate

Three Months Ended March 31, 2015

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.

RECONCILIATION OF NON-GAAP EPS TO GAAP EPS

Net Earnings Attributable to BMS used for Diluted EPS Calculation - GAAP

Less Specified Items*

Net Earnings used for Diluted EPS Calculation – Non-GAAP

Average Common Shares Outstanding- Diluted

Diluted Earnings Per Share — GAAP

Diluted EPS Attributable to Specified Items

Diluted Earnings Per Share — Non-GAAP

NET CASH/(DEBT) CALCULATION

AS OF

DECEMBER 31, 2015

December 31, 2015

Cash and cash equivalents

Marketable securities - current

Marketable securities - non-current

Cash, cash equivalents and marketable securities

Short-term borrowings

Long-term debt

(6,593

(6,550

Net cash position

The above information was disclosed in a filing to the SEC. To see the filing, click here.

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Other recent filings from the company include the following:

Bristol-Myers Squibb: Soliciting Material Under §240.14A-12 Bristol-Myers Squibb Company - April 18, 2016
Bristol-Myers Squibb Company director just disposed of 23,200 shares - April 6, 2016
Bristol-Myers Squibb Company director was just granted 2,188 restricted shares - April 5, 2016
SVP of Bristol-Myers Squibb Company just picked up 854 shares - April 5, 2016