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Bristol-Myers Squibb Reports First Quarter Financial Results

April 28, 2016 6:59 AM

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

$ amounts in millions, except per share amounts

2016

2015

Change

Total Revenues $4,391 $4,041 9%
GAAP Diluted EPS 0.71 0.71
Non-GAAP Diluted EPS 0.74 0.71 4%

FIRST QUARTER FINANCIAL RESULTS

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

Empliciti

Daklinza

Revlimid® is a trademark of Celgene Corporation.

BUSINESS DEVELOPMENT UPDATE

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:

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, [email protected], Communications; Ranya Dajani, 609-252-5330, [email protected] or Bill Szablewski, 609-252-5894, [email protected], Investor Relations.

BRISTOL-MYERS SQUIBB COMPANYPRODUCT REVENUEFOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2015(Unaudited, dollars in millions)

Worldwide Revenues U.S. Revenues
2016 2015

%Change

2016 2015

%Change

Three Months Ended March 31,

Key Products
Oncology
Empliciti $ 28 $ N/A $ 28 $ N/A
Erbitux(a) 165 (100 )% 157 (100 )%
Opdivo 704 40 ** 594 38 **
Sprycel 407 375 9 % 210 181 16 %
Yervoy 263 325 (19 )% 199 181 10 %
Cardiovascular
Eliquis 734 355 ** 468 200 **
Immunoscience
Orencia 475 400 19 % 321 259 24 %
Virology
Baraclude 291 340 (14 )% 17 46 (63 )%
Hepatitis C Franchise 427 264 62 % 259 N/A
Reyataz Franchise 221 294 (25 )% 120 143 (16 )%
Sustiva Franchise 273 290 (6 )% 228 234 (3 )%
Neuroscience
Abilify(b) 33 554 (94 )% 508 (100 )%
Mature Products and All Other 535 639 (16 )% 93 97 (4 )%
Total $ 4,391 $ 4,041 9 % $ 2,537 $ 2,044 24 %
** In excess of +/- 100%
(a) Erbitux is a trademark of ImClone LLC. ImClone LLC is a wholly-owned subsidiary of Eli Lilly and Company.
(b) Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.

BRISTOL-MYERS SQUIBB COMPANYCONSOLIDATED STATEMENTS OF EARNINGSFOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2015(Unaudited, dollars and shares in millions except per share data)

Three Months EndedMarch 31,

2016 2015
Net product sales $ 3,964 $ 3,059
Alliance and other revenues 427 982
Total Revenues 4,391 4,041
Cost of products sold 1,052 847
Marketing, selling and administrative 1,068 1,029
Research and development 1,136 1,016
Other (income)/expense (520 ) (299 )
Total Expenses 2,736 2,593
Earnings Before Income Taxes 1,655 1,448
Provision for Income Taxes 449 249
Net Earnings 1,206 1,199
Net Earnings Attributable to Noncontrolling Interest 11 13
Net Earnings Attributable to BMS $ 1,195 $ 1,186
Average Common Shares Outstanding:
Basic 1,669 1,663
Diluted 1,680 1,676
Earnings per Common Share
Basic $ 0.72 $ 0.71
Diluted $ 0.71 $ 0.71
Other (Income)/Expense
Interest expense $ 43 $ 51
Investment income (24 ) (30 )
Provision for restructuring 4 12
Litigation and other settlements 43 12
Equity in net income of affiliates (26 ) (26 )
Out-licensed intangible asset impairment 15 13
Divestiture gains (270 ) (154 )
Royalties and licensing income (254 ) (98 )
Transition and other service fees (53 ) (27 )
Pension charges 22 27
Written option adjustment (36 )
Other (20 ) (43 )
Other (income)/expense $ (520 ) $ (299 )

BRISTOL-MYERS SQUIBB COMPANYSPECIFIED ITEMSFOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2015(Unaudited, dollars in millions)

Three Months EndedMarch 31,

2016 2015
Cost of products sold(a) $ 4 $ 34
Marketing, selling and administrative 1
License and asset acquisition charges 125 162
Other 13
Research and development 138 162
Provision for restructuring 4 12
Divestiture gains (269 ) (152 )
Pension charges 22 27
Written option adjustment (36 )
Litigation and other settlements 43 14
Out-licensed intangible asset impairment 15 13
Other (income)/expense (185 ) (122 )
Increase/(decrease) to pretax income (43 ) 75
Income tax on items above 83 (68 )
Increase to net earnings $ 40 $ 7
(a) Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs.

BRISTOL-MYERS SQUIBB COMPANYRECONCILIATION OF CERTAIN NON-GAAP LINE ITEMS TO CERTAIN GAAP LINE ITEMSFOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2015(Unaudited, dollars in millions)

Three Months Ended March 31, 2016

GAAP

SpecifiedItems(a)

Non-GAAP

Gross Profit $ 3,339 $ 4 $ 3,343
Marketing, selling and administrative 1,068 1,068
Research and development 1,136 (138 ) 998
Other (income)/expense (520 ) 185 (335 )
Effective Tax Rate 27.1 % (4.4 )% 22.7 %

Three Months Ended March 31, 2015

GAAP

SpecifiedItems(a)

Non-GAAP

Gross Profit $ 3,194 $ 34 $ 3,228
Marketing, selling and administrative 1,029 (1 ) 1,028
Research and development 1,016 (162 ) 854
Other (income)/expense (299 ) 122 (177 )
Effective Tax Rate 17.2 % 3.6 % 20.8 %
(a) Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate.

BRISTOL-MYERS SQUIBB COMPANYRECONCILIATION OF NON-GAAP EPS TO GAAP EPSFOR THE THREE MONTHS ENDED MARCH 31, 2016 AND 2015(Unaudited, dollars and shares in millions except per share data)

Three Months EndedMarch 31,

2016 2015
Net Earnings Attributable to BMS used for Diluted EPS Calculation - GAAP $ 1,195 $ 1,186
Less Specified Items* 40 7
Net Earnings used for Diluted EPS Calculation – Non-GAAP $ 1,235 $ 1,193
Average Common Shares Outstanding- Diluted 1,680 1,676
Diluted Earnings Per Share — GAAP $ 0.71 $ 0.71
Diluted EPS Attributable to Specified Items 0.03
Diluted Earnings Per Share — Non-GAAP $ 0.74 $ 0.71
* Refer to the Specified Items schedule for further details.

BRISTOL-MYERS SQUIBB COMPANYNET CASH/(DEBT) CALCULATIONAS OF MARCH 31, 2016 AND DECEMBER 31, 2015(Unaudited, dollars in millions)

March 31, 2016 December 31, 2015
Cash and cash equivalents $ 2,644 $ 2,385
Marketable securities - current 1,663 1,885
Marketable securities - non-current 3,689 4,660
Cash, cash equivalents and marketable securities 7,996 8,930
Short-term borrowings (106 ) (139 )
Long-term debt (6,593 ) (6,550 )
Net cash position $ 1,297 $ 2,241

Bristol-Myers Squibb Company

Communications:

Ken Dominski, 609-252-5251

[email protected]

or

Investor Relations:

Ranya Dajani, 609-252-5330

[email protected]

or

Bill Szablewski, 609-252-5894

[email protected]

Source: Bristol-Myers Squibb Company

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