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Bristol-Myers Squibb Reports Fourth Quarter and Full Year 2016 Financial Results

January 26, 2017 6:59 AM

NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today reported results for the fourth quarter and full year of 2016, which were highlighted by strong sales for key products Opdivo and Eliquis, regulatory approvals for Opdivo in the U.S. and Europe, and strategic transactions in oncology and fibrosis that further strengthened the company’s pipeline.

“Bristol-Myers Squibb achieved outstanding operating and financial results in 2016, driven by strong commercial performance across our portfolio,” said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “In 2017, we will continue to advance our pipeline, drive strong commercial execution across the business and progress our broad portfolio of Immuno-Oncology medicines.”

Fourth Quarter
$ amounts in millions, except per share amounts
2016 2015 Change
Total Revenues $5,243 $4,287 22%
GAAP Diluted EPS 0.53 (0.12) **
Non-GAAP Diluted EPS 0.63 0.38 66%
Full Year
$ amounts in millions, except per share amounts
2016 2015 Change
Total Revenues $19,427 $16,560 17%
GAAP Diluted EPS 2.65 0.93 **
Non-GAAP Diluted EPS 2.83 2.01 41%

** In excess of +/- 100%

FOURTH QUARTER FINANCIAL RESULTS

FOURTH QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

Global revenues for the fourth quarter of 2016, compared to the fourth quarter of 2015, were driven by:

Opdivo

Litigation

Regulatory

Clinical

FOURTH QUARTER BUSINESS DEVELOPMENT UPDATE

2017 FINANCIAL GUIDANCE

Bristol-Myers Squibb is confirming its 2017 GAAP EPS guidance range of $2.47 - $2.67 and is adjusting its non-GAAP EPS guidance range from $2.85 - $3.05 to $2.70 - $2.90. Both GAAP and non-GAAP guidance assume current exchange rates. 2017 GAAP and non-GAAP line-item guidance assumptions include:

As previously announced in the third quarter of 2016, the company’s operating model is evolving, to drive the company’s continued success in the near- and long-term. The majority of costs are expected to be incurred by 2020. Although GAAP operating expenses may increase initially as restructuring and other charges are incurred relating to this evolution, the company expects non-GAAP operating expenses to be roughly flat with 2016 levels through 2020.

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 guidance also assumes no generic entry for Sprycel in Europe following the appeal of the European Patent Office’s decision. 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.

Erbitux® is a trademark of ImClone LLC.Keytruda® is a trademark of Merck & Co., Inc.Adcetris® is a trademark of Seattle Genetics, Inc.Darzalex® is a trademark of Janssen Biotech, 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, pension, legal and other contractual settlement charges 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 January 26, 2017 at 10:30 a.m. EST 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 877-201-0168 or international 647-788-4901, confirmation code: 60705823. 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. EST on January 26, 2017 through 11:59 p.m. EST on February 9, 2017. The replay will also be available through http://investor.bms.com or by calling the U.S. toll free 855-859-2056 or international 404-537-3406, confirmation code: 60705823.

For more information, contact: Ken Dominski, 609-252-5251, [email protected], Communications; John Elicker, 609-252-4611, [email protected], Tim Power, 609-252-7509, [email protected] or Bill Szablewski, 609-252-5894, [email protected], Investor Relations.

BRISTOL-MYERS SQUIBB COMPANY

PRODUCT REVENUE

FOR THE THREE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited, dollars in millions)

Worldwide Revenues U.S. Revenues
2016 2015 %

Change

2016 2015 %

Change

Three Months Ended December 31,

Key Products
Oncology
Empliciti $ 47 $ 3 ** $ 36 $ 3 **
Erbitux(a)
Opdivo 1,310 475 ** 715 410 74 %
Sprycel 494 429 15 % 267 228 17 %
Yervoy 264 265 202 164 23 %
Cardiovascular
Eliquis 948 602 57 % 539 335 61 %
Immunoscience
Orencia 625 540 16 % 423 372 14 %
Virology
Baraclude 296 309 (4 )% 17 27 (37 )%
Hepatitis C Franchise 226 458 (51 )% 82 212 (61 )%
Reyataz Franchise 206 272 (24 )% 117 142 (18 )%
Sustiva Franchise 246 312 (21 )% 212 269 (21 )%
Neuroscience
Abilify(b) 31 39 (21 )% 7 (100 )%
Mature Products and All Other 550 583 (6 )% 95 94 1 %
Total $ 5,243 $ 4,287 22 % $ 2,705 $ 2,263 20 %
** 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 COMPANY

PRODUCT REVENUE

FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited, dollars in millions)

Worldwide Revenues U.S. Revenues
2016 2015 %

Change

2016 2015 %

Change

Twelve Months Ended December 31,

Key Products
Oncology
Empliciti $ 150 $ 3 ** $ 133 $ 3 **
Erbitux 501 (100 )% 487 (100 )%
Opdivo 3,774 942 ** 2,664 823 **
Sprycel 1,824 1,620 13 % 969 829 17 %
Yervoy 1,053 1,126 (6 )% 802 602 33 %
Cardiovascular
Eliquis 3,343 1,860 80 % 1,963 1,023 92 %
Immunoscience
Orencia 2,265 1,885 20 % 1,532 1,271 21 %
Virology
Baraclude 1,192 1,312 (9 )% 66 135 (51 )%
Hepatitis C Franchise 1,578 1,603 (2 )% 827 323 **
Reyataz Franchise 912 1,139 (20 )% 484 591 (18 )%
Sustiva Franchise 1,065 1,252 (15 )% 901 1,041 (13 )%
Neuroscience
Abilify 128 746 (83 )% 600 (100 )%
Mature Products and All Other 2,143 2,571 (17 )% 379 460 (18 )%
Total $ 19,427 $ 16,560 17 % $ 10,720 $ 8,188 31 %

** In excess of +/- 100%

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2016 AND 2015

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

Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Net product sales $ 4,814 $ 3,862 $ 17,702 $ 14,045
Alliance and other revenues 429 425 1,725 2,515
Total Revenues 5,243 4,287 19,427 16,560
Cost of products sold 1,383 952 4,946 3,909
Marketing, selling and administrative 1,461 1,501 4,911 4,841
Research and development 1,400 1,916 4,940 5,920
Other (income)/expense (87 ) 328 (1,285 ) (187 )
Total Expenses 4,157 4,697 13,512 14,483
Earnings/(Loss) Before Income Taxes 1,086 (410 ) 5,915 2,077
Provision for/(Benefit from) Income Taxes 188 (222 ) 1,408 446
Net Earnings/(Loss) 898 (188 ) 4,507 1,631
Net Earnings Attributable to Noncontrolling Interest 4 9 50 66
Net Earnings/(Loss) Attributable to BMS $ 894 $ (197 ) $ 4,457 $ 1,565
Average Common Shares Outstanding:
Basic 1,672 1,669 1,671 1,667
Diluted 1,680 1,669 1,680 1,679
Earnings/(Loss) per Common Share
Basic $ 0.53 $ (0.12 ) $ 2.67 $ 0.94
Diluted $ 0.53 $ (0.12 ) $ 2.65 $ 0.93
Other (Income)/Expense
Interest expense $ 40 $ 43 $ 167 $ 184
Investment income (24 ) (27 ) (105 ) (101 )
Provision for restructuring 68 68 109 118
Litigation and other settlements (1 ) 145 47 159
Equity in net income of affiliates (12 ) (16 ) (77 ) (83 )
Divestiture (gains)/losses (2 ) 174 (576 ) (196 )
Royalties and licensing income (140 ) (125 ) (719 ) (383 )
Transition and other service fees (54 ) (31 ) (238 ) (122 )
Pension charges 25 49 91 160
Intangible asset impairment 15 13
Equity investment impairment 45
Written option adjustment (123 )
Loss on debt redemption 180
Other 13 48 (44 ) 7
Other (income)/expense $ (87 ) $ 328 $ (1,285 ) $ (187 )

BRISTOL-MYERS SQUIBB COMPANY

SPECIFIED ITEMS

FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited, dollars in millions)

Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
Cost of products sold(a) $ 6 $ 10 $ 21 $ 84
Marketing, selling and administrative 4 10
License and asset acquisition charges 130 554 439 1,679
IPRD impairments 13 160 13 160
Accelerated depreciation and other 43 27 83 44
Research and development 186 741 535 1,883
Provision for restructuring 68 65 109 115
Divestiture (gains)/losses 171 (559 ) (187 )
Pension charges 25 49 91 160
Written option adjustment (123 )
Litigation and other settlements 143 40 158
Intangible asset impairment 15 13
Loss on debt redemption 180
Royalties and licensing income (10 ) (10 )
Other (income)/expense 83 428 (314 ) 316
Increase to pretax income 275 1,183 242 2,293
Income tax on items above (105 ) (339 ) 51 (480 )
Increase to net earnings $ 170 $ 844 $ 293 $ 1,813

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

BRISTOL-MYERS SQUIBB COMPANY

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

FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2016 AND 2015

(Unaudited, dollars in millions)

Three Months Ended December 31, 2016 Twelve Months Ended December 31, 2016
GAAP Specified

Items(a)

Non-

GAAP

GAAP Specified

Items(a)

Non-

GAAP

Gross Profit $ 3,860 $ 6 $ 3,866 $ 14,481 $ 21 $ 14,502
Marketing, selling and administrative 1,461 1,461 4,911 4,911
Research and development 1,400 (186 ) 1,214 4,940 (535 ) 4,405
Other (income)/expense (87 ) (83 ) (170 ) (1,285 ) 314 (971 )
Earnings Before Income Taxes 1,086 275 1,361 5,915 242 6,157
Provision for Income Taxes 188 (105 ) 293 1,408 51 1,357
Net Earnings Attributable to BMS used for Diluted EPS Calculation $ 894 $ 170 $ 1,064 $ 4,457 $ 293 $ 4,750
Average Common Shares Outstanding - Diluted 1,680 1,680 1,680 1,680 1,680 1,680
Diluted Earnings Per Share $ 0.53 $ 0.10 $ 0.63 $ 2.65 $ 0.18 $ 2.83
Effective Tax Rate 17.3 % 4.2 % 21.5 % 23.8 % (1.8 )% 22.0 %
Three Months Ended December 31, 2015 Twelve Months Ended December 31, 2015
GAAP SpecifiedItems(a) Non-GAAP GAAP SpecifiedItems(a) Non-GAAP
Gross Profit $ 3,335 $ 10 $ 3,345 $ 12,651 $ 84 $ 12,735
Marketing, selling and administrative 1,501 (4 ) 1,497 4,841 (10 ) 4,831
Research and development 1,916 (741 ) 1,175 5,920 (1,883 ) 4,037
Other (income)/expense 328 (428 ) (100 ) (187 ) (316 ) (503 )
Earnings/(Loss) Before Income Taxes (410 ) 1,183 773 2,077 2,293 4,370
Provision for/(Benefit from) Income Taxes (222 ) (339 ) 117 446 (480 ) 926
Net Earnings/(Loss) Attributable to BMS used for Diluted EPS Calculation $ (197 ) $ 844 $ 647 $ 1,565 $ 1,813 $ 3,378
Average Common Shares Outstanding - Diluted(b) 1,669 1,681 1,681 1,679 1,679 1,679
Diluted Earnings/(Loss) Per Share $ (0.12 ) $ 0.50 $ 0.38 $ 0.93 $ 1.08 $ 2.01
Effective Tax Rate 54.1 % (39.0 )% 15.1 % 21.5 % (0.3 )% 21.2 %
(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.
(b) Difference between GAAP and Non-GAAP Diluted Shares Outstanding for the three months ended December 31, 2015 relates to incremental shares attributable to share-based compensation plans.

BRISTOL-MYERS SQUIBB COMPANY

NET CASH/(DEBT) CALCULATION

AS OF DECEMBER 31, 2016 AND SEPTEMBER 30, 2016

(Unaudited, dollars in millions)

December 31, 2016 September 30, 2016
Cash and cash equivalents $ 4,237 $ 3,432
Marketable securities - current 2,113 2,128
Marketable securities - non-current 2,719 3,035
Cash, cash equivalents and marketable securities 9,069 8,595
Short-term borrowings and current portion of long-term debt (992 ) (990 )
Long-term debt (5,716 ) (5,836 )
Net cash position $ 2,361 $ 1,769

Bristol-Myers Squibb Company

Communications:

Ken Dominski, 609-252-5251

[email protected]

or

Investor Relations:

John Elicker, 609-252-4611

[email protected]

Tim Power, 609-252-7509

[email protected]

Bill Szablewski, 609-252-5894

[email protected]

Source: Bristol-Myers Squibb Company

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