DELAWARE (State of Incorporation) | 13-5315170 (I.R.S. Employer Identification No.) |
YES X | NO ___ |
YES X | NO ___ |
YES ____ | NO X |
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Condensed Consolidated Statements of Income for the three and six months ended June 28, 2015 and June 29, 2014 | |
Condensed Consolidated Statements of Comprehensive Income for the three and six months ended June 28, 2015 and June 29, 2014 | |
Condensed Consolidated Balance Sheets as of June 28, 2015 and December 31, 2014 | |
Condensed Consolidated Statements of Cash Flows for the three and six months ended June 28, 2015 and June 29, 2014 | |
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS, EXCEPT PER COMMON SHARE DATA) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Revenues | $ | 11,853 | $ | 12,773 | $ | 22,717 | $ | 24,126 | ||||||||
Costs and expenses: | ||||||||||||||||
Cost of sales(a) | 2,180 | 2,462 | 4,018 | 4,507 | ||||||||||||
Selling, informational and administrative expenses(a) | 3,386 | 3,520 | 6,491 | 6,560 | ||||||||||||
Research and development expenses(a) | 1,734 | 1,759 | 3,620 | 3,382 | ||||||||||||
Amortization of intangible assets | 872 | 1,001 | 1,811 | 2,118 | ||||||||||||
Restructuring charges and certain acquisition-related costs | 86 | 81 | 146 | 139 | ||||||||||||
Other (income)/deductions––net | 55 | (53 | ) | 9 | 570 | |||||||||||
Income from continuing operations before provision for taxes on income | 3,539 | 4,003 | 6,621 | 6,850 | ||||||||||||
Provision for taxes on income | 905 | 1,082 | 1,610 | 1,664 | ||||||||||||
Income from continuing operations | 2,635 | 2,921 | 5,011 | 5,186 | ||||||||||||
Discontinued operations––net of tax | 1 | — | 6 | 73 | ||||||||||||
Net income before allocation to noncontrolling interests | 2,635 | 2,921 | 5,017 | 5,259 | ||||||||||||
Less: Net income attributable to noncontrolling interests | 9 | 9 | 14 | 18 | ||||||||||||
Net income attributable to Pfizer Inc. | $ | 2,626 | $ | 2,912 | $ | 5,002 | $ | 5,241 | ||||||||
Earnings per common share––basic: | ||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.43 | $ | 0.46 | $ | 0.81 | $ | 0.81 | ||||||||
Discontinued operations––net of tax | — | — | — | 0.01 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.43 | $ | 0.46 | $ | 0.81 | $ | 0.82 | ||||||||
Earnings per common share––diluted: | ||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.42 | $ | 0.45 | $ | 0.80 | $ | 0.80 | ||||||||
Discontinued operations––net of tax | — | — | — | 0.01 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.42 | $ | 0.45 | $ | 0.80 | $ | 0.81 | ||||||||
Weighted-average shares––basic | 6,159 | 6,368 | 6,181 | 6,379 | ||||||||||||
Weighted-average shares––diluted | 6,243 | 6,444 | 6,267 | 6,460 | ||||||||||||
Cash dividends paid per common share | $ | 0.28 | $ | 0.26 | $ | 0.56 | $ | 0.52 |
(a) | Excludes amortization of intangible assets, except as disclosed in Note 9A. Identifiable Intangible Assets and Goodwill:Identifiable Intangible Assets. |
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Net income before allocation to noncontrolling interests | $ | 2,635 | $ | 2,921 | $ | 5,017 | $ | 5,259 | ||||||||
Foreign currency translation adjustments, net | $ | (327 | ) | $ | 233 | $ | (1,635 | ) | $ | 158 | ||||||
Reclassification adjustments(a) | — | — | — | (62 | ) | |||||||||||
(327 | ) | 233 | (1,635 | ) | 96 | |||||||||||
Unrealized holding gains/(losses) on derivative financial instruments, net | 452 | 1 | 137 | (57 | ) | |||||||||||
Reclassification adjustments for realized (gains)/losses(b) | (743 | ) | 74 | (510 | ) | 86 | ||||||||||
(291 | ) | 75 | (373 | ) | 29 | |||||||||||
Unrealized holding gains/(losses) on available-for-sale securities, net | (200 | ) | (15 | ) | (527 | ) | 93 | |||||||||
Reclassification adjustments for realized (gains)/losses(b) | 498 | (79 | ) | 745 | (178 | ) | ||||||||||
299 | (94 | ) | 218 | (85 | ) | |||||||||||
Benefit plans: actuarial gains/(losses), net | (9 | ) | (11 | ) | 22 | (5 | ) | |||||||||
Reclassification adjustments related to amortization(c) | 134 | 49 | 269 | 98 | ||||||||||||
Reclassification adjustments related to settlements, net(c) | 22 | 18 | 62 | 39 | ||||||||||||
Other | (29 | ) | (9 | ) | 130 | (26 | ) | |||||||||
118 | 47 | 483 | 106 | |||||||||||||
Benefit plans: prior service credits and other, net | 507 | — | 506 | — | ||||||||||||
Reclassification adjustments related to amortization(c) | (34 | ) | (18 | ) | (69 | ) | (36 | ) | ||||||||
Reclassification adjustments related to curtailments, net(c) | (7 | ) | 15 | (17 | ) | 11 | ||||||||||
Other | (2 | ) | — | (2 | ) | (1 | ) | |||||||||
464 | (3 | ) | 418 | (26 | ) | |||||||||||
Other comprehensive income/(loss), before tax | 263 | 258 | (890 | ) | 120 | |||||||||||
Tax provision/(benefit) on other comprehensive income/(loss)(d) | 228 | 5 | 332 | (12 | ) | |||||||||||
Other comprehensive income/(loss) before allocation to noncontrolling interests | $ | 35 | $ | 253 | $ | (1,222 | ) | $ | 132 | |||||||
Comprehensive income before allocation to noncontrolling interests | $ | 2,670 | $ | 3,174 | $ | 3,795 | $ | 5,391 | ||||||||
Less: Comprehensive income/(loss) attributable to noncontrolling interests | 8 | 24 | (3 | ) | 31 | |||||||||||
Comprehensive income attributable to Pfizer Inc. | $ | 2,663 | $ | 3,150 | $ | 3,797 | $ | 5,360 |
(a) | Reclassified into Discontinued operations—net of tax in the condensed consolidated statements of income. |
(b) | Reclassified into Other (income)/deductions—net in the condensed consolidated statements of income. |
(c) | Generally reclassified, as part of net periodic pension cost, into Cost of sales, Selling, informational and administrative expenses, and/or Research and development expenses, as appropriate, in the condensed consolidated statements of income. For additional information, see Note 10. Pension and Postretirement Benefit Plans. |
(d) | See Note 5C. Tax Matters: Tax Provision/(Benefit) on Other Comprehensive Income/(Loss). |
(MILLIONS OF DOLLARS) | June 28, 2015 | December 31, 2014 | ||||||
(Unaudited) | ||||||||
Assets | ||||||||
Cash and cash equivalents | $ | 3,670 | $ | 3,343 | ||||
Short-term investments | 26,586 | 32,779 | ||||||
Trade accounts receivable, less allowance for doubtful accounts: 2015—$397; 2014—$412 | 8,951 | 8,401 | ||||||
Inventories | 5,796 | 5,663 | ||||||
Current deferred tax assets and other current tax assets | 4,263 | 4,498 | ||||||
Other current assets | 2,449 | 3,019 | ||||||
Total current assets | 51,715 | 57,702 | ||||||
Long-term investments | 17,650 | 17,518 | ||||||
Property, plant and equipment, less accumulated depreciation | 11,432 | 11,762 | ||||||
Identifiable intangible assets, less accumulated amortization | 33,424 | 35,166 | ||||||
Goodwill | 41,571 | 42,069 | ||||||
Noncurrent deferred tax assets and other noncurrent tax assets | 1,450 | 1,544 | ||||||
Other noncurrent assets | 3,635 | 3,513 | ||||||
Total assets | $ | 160,878 | $ | 169,274 | ||||
Liabilities and Equity | ||||||||
Short-term borrowings, including current portion of long-term debt | $ | 8,394 | $ | 5,141 | ||||
Trade accounts payable | 2,930 | 3,210 | ||||||
Dividends payable | 1,726 | 1,711 | ||||||
Income taxes payable | 1,057 | 531 | ||||||
Accrued compensation and related items | 1,646 | 1,841 | ||||||
Other current liabilities | 8,390 | 9,197 | ||||||
Total current liabilities | 24,143 | 21,631 | ||||||
Long-term debt | 26,729 | 31,541 | ||||||
Pension benefit obligations, net | 6,529 | 7,885 | ||||||
Postretirement benefit obligations, net | 1,969 | 2,379 | ||||||
Noncurrent deferred tax liabilities | 24,659 | 24,981 | ||||||
Other taxes payable | 4,359 | 4,353 | ||||||
Other noncurrent liabilities | 5,310 | 4,883 | ||||||
Total liabilities | 93,698 | 97,652 | ||||||
Preferred stock | 28 | 29 | ||||||
Common stock | 458 | 455 | ||||||
Additional paid-in capital | 80,407 | 78,977 | ||||||
Treasury stock | (79,098 | ) | (73,021 | ) | ||||
Retained earnings | 73,620 | 72,176 | ||||||
Accumulated other comprehensive loss | (8,521 | ) | (7,316 | ) | ||||
Total Pfizer Inc. shareholders’ equity | 66,894 | 71,301 | ||||||
Equity attributable to noncontrolling interests | 286 | 321 | ||||||
Total equity | 67,180 | 71,622 | ||||||
Total liabilities and equity | $ | 160,878 | $ | 169,274 |
Six Months Ended | ||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | ||||||
Operating Activities | ||||||||
Net income before allocation to noncontrolling interests | $ | 5,017 | $ | 5,259 | ||||
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 2,461 | 2,880 | ||||||
Asset write-offs and impairments | 42 | 189 | ||||||
Adjustment to gain on disposal of discontinued operations | — | (66 | ) | |||||
Deferred taxes from continuing operations | (183 | ) | 853 | |||||
Deferred taxes from discontinued operations | — | (2 | ) | |||||
Share-based compensation expense | 347 | 281 | ||||||
Benefit plan contributions in excess of expense | (842 | ) | (124 | ) | ||||
Other adjustments, net | (194 | ) | (299 | ) | ||||
Other changes in assets and liabilities, net of acquisitions and divestitures | (1,873 | ) | (1,949 | ) | ||||
Net cash provided by operating activities | 4,775 | 7,022 | ||||||
Investing Activities | ||||||||
Purchases of property, plant and equipment | (497 | ) | (570 | ) | ||||
Purchases of short-term investments | (16,029 | ) | (21,081 | ) | ||||
Proceeds from redemptions/sales of short-term investments | 20,483 | 20,795 | ||||||
Net proceeds from redemptions/sales of short-term investments with original maturities of 90 days or less | 3,020 | 1,399 | ||||||
Purchases of long-term investments | (5,422 | ) | (5,327 | ) | ||||
Proceeds from redemptions/sales of long-term investments | 3,291 | 2,947 | ||||||
Acquisitions of businesses, net of cash acquired | (679 | ) | — | |||||
Acquisitions of intangible assets | (12 | ) | (56 | ) | ||||
Other investing activities, net | 333 | 288 | ||||||
Net cash provided by/(used in) investing activities | 4,487 | (1,605 | ) | |||||
Financing Activities | ||||||||
Proceeds from short-term borrowings | 2,022 | 1 | ||||||
Principal payments on short-term borrowings | (10 | ) | (7 | ) | ||||
Net proceeds from/(payments on) short-term borrowings with original maturities of 90 days or less | 481 | (2,692 | ) | |||||
Proceeds from issuance of long-term debt | — | 4,491 | ||||||
Principal payments on long-term debt | (3,002 | ) | (752 | ) | ||||
Purchases of common stock | (6,000 | ) | (2,520 | ) | ||||
Cash dividends paid | (3,483 | ) | (3,320 | ) | ||||
Proceeds from exercise of stock options | 981 | 583 | ||||||
Other financing activities, net | 154 | 43 | ||||||
Net cash used in financing activities | (8,857 | ) | (4,173 | ) | ||||
Effect of exchange-rate changes on cash and cash equivalents | (78 | ) | (21 | ) | ||||
Net increase in cash and cash equivalents | 327 | 1,223 | ||||||
Cash and cash equivalents, beginning | 3,343 | 2,183 | ||||||
Cash and cash equivalents, end | $ | 3,670 | $ | 3,406 | ||||
Supplemental Cash Flow Information | ||||||||
Cash paid during the period for: | ||||||||
Income taxes | $ | 1,124 | $ | 1,068 | ||||
Interest | 914 | 996 |
• | Quoted prices for identical assets or liabilities in active markets (Level 1 inputs). |
• | Quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs). |
• | Unobservable inputs that reflect estimates and assumptions (Level 3 inputs). |
• | In connection with acquisition activity, we typically incur costs associated with executing the transactions, integrating the acquired operations (which may include expenditures for consulting and the integration of systems and processes), and restructuring the combined company (which may include charges related to employees, assets and activities that will not continue in the combined company); and |
• | In connection with our cost-reduction/productivity initiatives, we typically incur costs and charges associated with site closings and other facility rationalization actions, workforce reductions and the expansion of shared services, including the development of global systems. |
• | Manufacturing plant network rationalization and optimization, where execution timelines are necessarily long. Our plant network strategy is expected to result in the exit of five sites over the next several years. In connection with these activities, during 2014-2016, we expect to incur costs of approximately $300 million associated with prior acquisition activity and costs of approximately $1.3 billion associated with new non-acquisition-related cost-reduction initiatives. Through June 28, 2015, we incurred approximately $252 million and $340 million, respectively, associated with these initiatives. |
• | New global commercial structure reorganization, which primarily includes the streamlining of certain functions, the realignment of regional locations and colleagues to support the businesses, as well as implementing the necessary system changes to support future reporting requirements. In connection with this reorganization, during 2014-2016, we expect to incur costs of approximately $300 million. Through June 28, 2015, we incurred approximately $191 million associated with this reorganization. |
• | Other new cost-reduction/productivity initiatives, primarily related to commercial property rationalization and consolidation. In connection with these cost-reduction activities, during 2014-2016, we expect to incur costs of approximately $900 million. Through June 28, 2015, we incurred approximately $263 million associated with these initiatives. |
The following table provides the components of costs associated with acquisitions and cost-reduction/productivity initiatives: | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Restructuring charges(a): | ||||||||||||||||
Employee terminations | $ | 34 | $ | 17 | $ | 65 | $ | 47 | ||||||||
Asset impairments | 5 | 13 | 11 | 19 | ||||||||||||
Exit costs | 4 | 36 | 10 | 40 | ||||||||||||
Total restructuring charges | 43 | 66 | 85 | 106 | ||||||||||||
Transaction costs(b) | 1 | — | 6 | — | ||||||||||||
Pre-integration/integration costs(c) | 42 | 15 | 54 | 33 | ||||||||||||
Restructuring charges and certain acquisition-related costs | 86 | 81 | 146 | 139 | ||||||||||||
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(d): | ||||||||||||||||
Cost of sales | 28 | 72 | 45 | 146 | ||||||||||||
Selling, informational and administrative expenses | — | 1 | — | 1 | ||||||||||||
Research and development expenses | 1 | 29 | 2 | 29 | ||||||||||||
Total additional depreciation––asset restructuring | 28 | 102 | 47 | 176 | ||||||||||||
Implementation costs recorded in our condensed consolidated statements of income as follows(e): | ||||||||||||||||
Cost of sales | 28 | 22 | 41 | 28 | ||||||||||||
Selling, informational and administrative expenses | 13 | 38 | 39 | 53 | ||||||||||||
Research and development expenses | 3 | 16 | 12 | 27 | ||||||||||||
Other (income)/deductions––net | 1 | — | 1 | — | ||||||||||||
Total implementation costs | 45 | 76 | 93 | 108 | ||||||||||||
Total costs associated with acquisitions and cost-reduction/productivity initiatives | $ | 159 | $ | 259 | $ | 286 | $ | 423 |
(a) | In the six months ended June 28, 2015, Employee terminations represent the expected reduction of the workforce by approximately 500 employees, mainly in sales. |
• | For the second quarter of 2015, the Global Innovative Pharmaceutical segment (GIP) ($7 million); the Global Vaccines, Oncology and Consumer Healthcare segment (VOC) ($14 million); the Global Established Pharmaceutical segment (GEP) ($2 million income); Worldwide Research and Development and Medical (WRD/M) ($4 million); manufacturing operations ($14 million); and Corporate ($6 million). |
• | For the first six months of 2015, GIP ($19 million); VOC ($27 million); GEP ($8 million); WRD/M ($16 million); manufacturing operations ($8 million income); and Corporate ($24 million). |
• | For the second quarter of 2014, GIP ($9 million); VOC ($6 million); GEP ($24 million); WRD/M ($8 million); manufacturing operations ($12 million); and Corporate ($7 million). |
• | For the first six months of 2014, GIP ($11 million); VOC ($6 million); GEP ($31 million); WRD/M ($9 million); manufacturing operations ($38 million); and Corporate ($11 million). |
(b) | Transaction costs represent external costs directly related to acquired businesses and primarily include expenditures for banking, legal, accounting and other similar services. |
(c) | Pre-integration costs represent external, incremental costs directly related to our pending acquisition with Hospira. Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. |
(d) | Additional depreciation––asset restructuring represents the impact of changes in the estimated useful lives of assets involved in restructuring actions. |
(e) | Implementation costs represent external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives. |
The following table provides the components of and changes in our restructuring accruals: | ||||||||||||||||
(MILLIONS OF DOLLARS) | Employee Termination Costs | Asset Impairment Charges | Exit Costs | Accrual | ||||||||||||
Balance, December 31, 2014(a) | $ | 1,114 | $ | — | $ | 52 | $ | 1,166 | ||||||||
Provision | 65 | 11 | 10 | 85 | ||||||||||||
Utilization and other(b) | (197 | ) | (11 | ) | (36 | ) | (244 | ) | ||||||||
Balance, June 28, 2015(c) | $ | 982 | $ | — | $ | 26 | $ | 1,008 |
(a) | Included in Other current liabilities ($735 million) and Other noncurrent liabilities ($431 million). |
(b) | Includes adjustments for foreign currency translation. |
(c) | Included in Other current liabilities ($575 million) and Other noncurrent liabilities ($433 million). |
The following table provides components of Other (income)/deductions––net: | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Interest income(a) | $ | (119 | ) | $ | (104 | ) | $ | (211 | ) | $ | (196 | ) | ||||
Interest expense(a) | 278 | 343 | 587 | 664 | ||||||||||||
Net interest expense | 159 | 239 | 375 | 468 | ||||||||||||
Royalty-related income | (257 | ) | (239 | ) | (479 | ) | (487 | ) | ||||||||
Certain legal matters, net(b) | 99 | (2 | ) | 99 | 692 | |||||||||||
Net gains on asset disposals(c) | (19 | ) | (33 | ) | (195 | ) | (214 | ) | ||||||||
Certain asset impairments(d) | 25 | — | 25 | 115 | ||||||||||||
Business and legal entity alignment costs(e) | 63 | 39 | 164 | 67 | ||||||||||||
Other, net | (15 | ) | (57 | ) | 20 | (71 | ) | |||||||||
Other (income)/deductions––net | $ | 55 | $ | (53 | ) | $ | 9 | $ | 570 |
(a) | Interest income increased in the second quarter and first six months of 2015, primarily due to higher investment returns. Interest expense decreased in the second quarter and first six months of 2015, primarily due to lower interest rates on new fixed rate debt added in the second quarter of 2014, the repayment of some long-term debt in the first quarter of 2015 and the benefit of the effective conversion of some fixed-rate liabilities to floating-rate liabilities. |
(b) | In the first six months of 2014, primarily includes approximately $620 million for Neurontin-related matters (including off-label promotion actions and antitrust actions) and approximately $55 million for an Effexor-related matter. |
(c) | In the first six months of 2015, primarily includes gains on sales/out-licensing of product and compound rights (approximately $69 million) and gains on sales of investments in equity securities (approximately $125 million). In the first six months of 2014, primarily includes gains on sales/out-licensing of product and compound rights (approximately $96 million) and gains on sales of investments in equity securities (approximately $98 million). |
(d) | In the first six months of 2014, includes intangible asset impairment charges of $114 million, virtually all of which relates to an in-process research and development (IPR&D) compound for the treatment of skin fibrosis. The intangible asset impairment charge for the first six months of 2014 is associated with Worldwide Research and Development and reflects, among other things, the impact of changes to the development program. |
(e) | In the second quarter and first six months of 2015 and 2014, represents expenses for planning and implementing changes to our infrastructure to align our operations and reporting for our business segments established in 2014. |
• | the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, |
• | a decline in tax benefits associated with the resolution of certain tax positions pertaining to prior years, with various foreign tax authorities, and the expiration of certain statutes of limitations. |
• | the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, |
• | a decline in tax benefits associated with the resolution of certain tax positions pertaining to prior years, primarily with various foreign tax authorities, and the expiration of certain statutes of limitations. |
• | With respect to Pfizer Inc., the IRS has issued a Revenue Agent’s Report (RAR) for tax years 2009-2010. We are not in agreement with the RAR and are currently assessing the procedural options; it is likely that Pfizer will appeal certain disputed issues. Tax years 2011-2013 are currently under audit. Tax years 2014 and 2015 are open, but not under audit. All other tax years are closed. |
The following table provides the components of Tax provision/(benefit) on other comprehensive income/(loss): | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Foreign currency translation adjustments, net(a) | $ | 12 | $ | (3 | ) | $ | 97 | $ | (10 | ) | ||||||
Unrealized holding gains/(losses) on derivative financial instruments, net | 120 | 1 | (103 | ) | (16 | ) | ||||||||||
Reclassification adjustments for realized (gains)/losses | (155 | ) | 9 | 28 | 8 | |||||||||||
(34 | ) | 10 | (75 | ) | (8 | ) | ||||||||||
Unrealized holding gains/(losses) on available-for-sale securities, net | (37 | ) | (4 | ) | (69 | ) | 23 | |||||||||
Reclassification adjustments for realized (gains)/losses | 63 | (11 | ) | 62 | (40 | ) | ||||||||||
25 | (15 | ) | (7 | ) | (17 | ) | ||||||||||
Benefit plans: actuarial gains/(losses), net | (4 | ) | (3 | ) | 8 | (2 | ) | |||||||||
Reclassification adjustments related to amortization | 45 | 16 | 90 | 32 | ||||||||||||
Reclassification adjustments related to settlements, net | 8 | 7 | 23 | 15 | ||||||||||||
Other | 1 | 5 | 38 | (7 | ) | |||||||||||
49 | 25 | 159 | 38 | |||||||||||||
Benefit plans: prior service credits and other, net | 192 | — | 191 | — | ||||||||||||
Reclassification adjustments related to amortization | 7 | (7 | ) | (6 | ) | (14 | ) | |||||||||
Reclassification adjustments related to curtailments, net | (22 | ) | 2 | (26 | ) | 1 | ||||||||||
Other | (1 | ) | (7 | ) | (1 | ) | (2 | ) | ||||||||
176 | (12 | ) | 159 | (15 | ) | |||||||||||
Tax provision/(benefit) on other comprehensive income/(loss) | $ | 228 | $ | 5 | $ | 332 | $ | (12 | ) |
(a) | Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that will be held indefinitely. |
The following table provides the changes, net of tax, in Accumulated other comprehensive loss: | ||||||||||||||||||||||||
Net Unrealized Gains/(Losses) | Benefit Plans | |||||||||||||||||||||||
(MILLIONS OF DOLLARS) | Foreign Currency Translation Adjustments | Derivative Financial Instruments | Available-For-Sale Securities | Actuarial Gains/(Losses) | Prior Service (Costs)/Credits and Other | Accumulated Other Comprehensive Loss | ||||||||||||||||||
Balance, December 31, 2014 | $ | (2,689 | ) | $ | 517 | $ | (222 | ) | $ | (5,654 | ) | $ | 733 | $ | (7,316 | ) | ||||||||
Other comprehensive income/(loss)(a) | (1,715 | ) | (298 | ) | 225 | 324 | 259 | (1,205 | ) | |||||||||||||||
Balance, June 28, 2015 | $ | (4,404 | ) | $ | 219 | $ | 3 | $ | (5,330 | ) | $ | 992 | $ | (8,521 | ) |
(a) | Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests of $17 million loss for the first six months of 2015. |
The following table provides additional information about certain of our financial assets and liabilities: | ||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | December 31, 2014 | ||||||
Selected financial assets measured at fair value on a recurring basis(a) | ||||||||
Trading funds and securities(b) | $ | 297 | $ | 105 | ||||
Available-for-sale debt securities(c) | 40,150 | 39,762 | ||||||
Available-for-sale money market funds | 894 | 2,174 | ||||||
Available-for-sale equity securities, excluding money market funds(c) | 344 | 397 | ||||||
Derivative financial instruments in a receivable position(d): | ||||||||
Interest rate swaps | 668 | 801 | ||||||
Foreign currency swaps | 611 | 593 | ||||||
Foreign currency forward-exchange contracts | 317 | 547 | ||||||
43,282 | 44,379 | |||||||
Other selected financial assets | ||||||||
Held-to-maturity debt securities, carried at amortized cost(c), (e) | 2,133 | 7,255 | ||||||
Private equity securities, carried at equity-method or at cost(e), (f) | 1,829 | 1,993 | ||||||
3,962 | 9,248 | |||||||
Total selected financial assets | $ | 47,244 | $ | 53,627 | ||||
Selected financial liabilities measured at fair value on a recurring basis(a) | ||||||||
Derivative financial instruments in a liability position(g): | ||||||||
Interest rate swaps | $ | 380 | $ | 17 | ||||
Foreign currency swaps | 1,327 | 594 | ||||||
Foreign currency forward-exchange contracts | 266 | 78 | ||||||
1,973 | 689 | |||||||
Other selected financial liabilities(h) | ||||||||
Short-term borrowings, carried at historical proceeds, as adjusted(e) | 8,394 | 5,141 | ||||||
Long-term debt, carried at historical proceeds, as adjusted(i), (j) | 26,729 | 31,541 | ||||||
35,123 | 36,682 | |||||||
Total selected financial liabilities | $ | 37,095 | $ | 37,371 |
(a) | We use a market approach in valuing financial instruments on a recurring basis. For additional information, see Note 1C. All of our financial assets and liabilities measured at fair value on a recurring basis use Level 2 inputs in the calculation of fair value, except less than 1% that use Level 1 inputs. |
(b) | As of June 28, 2015, trading funds and securities are composed of $90 million of trading equity funds, $120 million of trading debt funds, and $86 million of trading equity securities. As of December 31, 2014, trading securities of $105 million is composed of debt and equity securities. The trading equity securities as of June 28, 2015 and the trading debt and equity securities as of December 31, 2014 are held in trust for benefits attributable to the former Pharmacia Savings Plus Plan. |
(c) | Gross unrealized gains and losses are not significant. |
(d) | Designated as hedging instruments, except for certain contracts used as offsets; namely, foreign currency forward-exchange contracts with fair values of $76 million as of June 28, 2015; and foreign currency forward-exchange contracts with fair values of $159 million as of December 31, 2014. |
(e) | Short-term borrowings includes foreign currency short-term borrowings with fair values of $536 million as of June 28, 2015, which are used as hedging instruments. The differences between the estimated fair values and carrying values of held-to-maturity debt securities, private equity securities at cost and short-term borrowings not measured at fair value on a recurring basis were not significant as of June 28, 2015 or December 31, 2014. The fair value measurements of our held-to-maturity debt securities and our short-term borrowings are based on Level 2 inputs, using a market approach. The fair value measurements of our private equity securities carried at cost are based on Level 3 inputs. |
(f) | Our private equity securities represent investments in the life sciences sector. |
(g) | Designated as hedging instruments, except for certain contracts used as offsets; namely, foreign currency swaps with fair values of $208 million and foreign currency forward-exchange contracts with fair values of $95 million as of June 28, 2015; and foreign currency swaps with fair values of $121 million and foreign currency forward-exchange contracts with fair values of $54 million as of December 31, 2014. |
(h) | Some carrying amounts may include adjustments for discount or premium amortization or for the effect of hedging the interest rate fair value risk associated with certain financial liabilities by interest rate swaps. |
(i) | Includes foreign currency debt with fair value of $560 million as of December 31, 2014, which are used as hedging instruments. |
(j) | The fair value of our long-term debt (not including the current portion of long-term debt) was $30.8 billion as of June 28, 2015 and $36.6 billion as of December 31, 2014. The fair value measurements for our long-term debt are based on Level 2 inputs, using a market approach. Generally, the difference between the fair value of our long-term debt and the amount reported on the condensed consolidated balance sheet is due to a decline in relative market interest rates since the debt issuance. |
The following table provides the classification of these selected financial assets and liabilities in our condensed consolidated balance sheets: | ||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | December 31, 2014 | ||||||
Assets | ||||||||
Cash and cash equivalents | $ | 1,412 | $ | 1,389 | ||||
Short-term investments | 26,586 | 32,779 | ||||||
Long-term investments | 17,650 | 17,518 | ||||||
Other current assets(a) | 831 | 1,059 | ||||||
Other noncurrent assets(b) | 765 | 881 | ||||||
$ | 47,244 | $ | 53,627 | |||||
Liabilities | ||||||||
Short-term borrowings, including current portion of long-term debt | $ | 8,394 | $ | 5,141 | ||||
Other current liabilities(c) | 858 | 93 | ||||||
Long-term debt | 26,729 | 31,541 | ||||||
Other noncurrent liabilities(d) | 1,114 | 596 | ||||||
$ | 37,095 | $ | 37,371 |
(a) | As of June 28, 2015, derivative instruments at fair value include interest rate swaps ($16 million), foreign currency swaps ($520 million) and foreign currency forward-exchange contracts ($294 million) and, as of December 31, 2014, include interest rate swaps ($34 million), foreign currency swaps ($494 million) and foreign currency forward-exchange contracts ($531 million). |
(b) | As of June 28, 2015, derivative instruments at fair value include interest rate swaps ($652 million), foreign currency swaps ($91 million) and foreign currency forward-exchange contracts ($23 million) and, as of December 31, 2014, include interest rate swaps ($767 million), foreign currency swaps ($99 million) and foreign currency forward-exchange contracts ($15 million). |
(c) | As of June 28, 2015, derivative instruments at fair value include interest rate swaps ($4 million), foreign currency swaps ($589 million) and foreign currency forward-exchange contracts ($265 million) and, as of December 31, 2014, include interest rate swaps ($1 million), foreign currency swaps ($13 million) and foreign currency forward-exchange contracts ($78 million). |
(d) | As of June 28, 2015, derivative instruments at fair value include interest rate swaps ($376 million), foreign currency swaps ($737 million) and foreign currency forward-exchange contracts ($1 million) and, as of December 31, 2014, include interest rate swaps ($16 million) and foreign currency swaps ($581 million). |
The following table provides the contractual maturities, or as necessary, the estimated maturities, of the available-for-sale and held-to-maturity debt securities: | ||||||||||||||||||||
Years | June 28, 2015 | |||||||||||||||||||
(MILLIONS OF DOLLARS) | Within 1 | Over 1 to 5 | Over 5 to 10 | Over 10 | Total | |||||||||||||||
Available-for-sale debt securities | ||||||||||||||||||||
Western European, Asian and other government debt(a) | $ | 13,586 | $ | 2,063 | $ | — | $ | — | $ | 15,649 | ||||||||||
Corporate debt(b) | 4,405 | 4,662 | 2,008 | 43 | 11,118 | |||||||||||||||
Western European, Scandinavian and other government agency debt(a) | 2,264 | 324 | — | — | 2,588 | |||||||||||||||
U.S. government debt | 377 | 1,713 | 66 | — | 2,155 | |||||||||||||||
Supranational debt(a) | 1,596 | 526 | — | — | 2,122 | |||||||||||||||
Federal Home Loan Mortgage Corporation and Federal National Mortgage Association asset-backed securities | 15 | 2,033 | 51 | — | 2,100 | |||||||||||||||
Government National Mortgage Association and other U.S. government guaranteed asset-backed securities | 189 | 721 | — | — | 910 | |||||||||||||||
Other asset-backed debt(c) | 893 | 959 | 3 | — | 1,855 | |||||||||||||||
Reverse repurchase agreements(d) | 1,652 | — | — | — | 1,652 | |||||||||||||||
Held-to-maturity debt securities | ||||||||||||||||||||
Time deposits, corporate debt and other(a) | 1,623 | 6 | — | — | 1,629 | |||||||||||||||
Western European government debt(a) | 504 | — | — | — | 504 | |||||||||||||||
Total debt securities | $ | 27,105 | $ | 13,008 | $ | 2,128 | $ | 43 | $ | 42,284 |
(a) | Issued by governments, government agencies or supranational entities, as applicable, all of which are investment-grade. |
(b) | Issued by a diverse group of corporations, largely consisting of financial institutions, virtually all of which are investment-grade. |
(c) | Includes loan-backed, receivable-backed, and mortgage-backed securities, all of which are investment-grade and in senior positions in the capital structure of the security. Loan-backed securities are collateralized by senior secured obligations of a diverse pool of companies or student loans, and receivable-backed securities are collateralized by credit cards receivables. Mortgage-backed securities are collateralized by diversified pools of residential and commercial mortgages. |
(d) | Involving U.S. securities. |
The following table provides information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk: | ||||||||||||||||||||||||
Amount of Gains/(Losses) Recognized in OID(a), (b), (c) | Amount of Gains/(Losses) Recognized in OCI (Effective Portion)(a), (d) | Amount of Gains/(Losses) Reclassified from OCI into OID (Effective Portion)(a), (d) | ||||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||||||||
Three Months Ended | ||||||||||||||||||||||||
Derivative Financial Instruments in Cash Flow Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency swaps | $ | — | $ | — | $ | 234 | $ | (3 | ) | $ | 240 | $ | 2 | |||||||||||
Foreign currency forward-exchange contracts | — | — | 204 | 4 | 502 | (76 | ) | |||||||||||||||||
Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency swaps | — | — | — | (3 | ) | — | — | |||||||||||||||||
Foreign currency forward-exchange contracts | — | — | 10 | — | — | — | ||||||||||||||||||
Derivative Financial Instruments Not Designated as Hedges: | ||||||||||||||||||||||||
Foreign currency forward-exchange contracts | (73 | ) | 32 | — | — | — | — | |||||||||||||||||
Foreign currency swaps | (2 | ) | 3 | — | — | — | — | |||||||||||||||||
Non-Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency short-term borrowings | — | — | 21 | — | — | — | ||||||||||||||||||
Foreign currency long-term debt | — | — | — | (8 | ) | — | — | |||||||||||||||||
All other net | — | — | 14 | — | — | — | ||||||||||||||||||
$ | (75 | ) | $ | 35 | $ | 483 | $ | (10 | ) | $ | 743 | $ | (74 | ) | ||||||||||
Six Months Ended | ||||||||||||||||||||||||
Derivative Financial Instruments in Cash Flow Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency swaps | $ | — | $ | — | $ | (498 | ) | $ | (18 | ) | $ | (365 | ) | $ | 11 | |||||||||
Foreign currency forward-exchange contracts | — | — | 621 | (39 | ) | 875 | (97 | ) | ||||||||||||||||
Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency swaps | — | — | — | (11 | ) | — | — | |||||||||||||||||
Foreign currency forward-exchange contracts | 2 | — | 259 | — | — | — | ||||||||||||||||||
Derivative Financial Instruments Not Designated as Hedges: | ||||||||||||||||||||||||
Foreign currency forward-exchange contracts | (113 | ) | — | — | — | — | — | |||||||||||||||||
Foreign currency swaps | (2 | ) | 20 | — | — | — | — | |||||||||||||||||
Non-Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||
Foreign currency short-term borrowings | — | — | 19 | — | — | — | ||||||||||||||||||
Foreign currency long-term debt | — | — | — | (22 | ) | — | — | |||||||||||||||||
All other net | — | (3 | ) | 14 | — | — | — | |||||||||||||||||
$ | (113 | ) | $ | 17 | $ | 416 | $ | (90 | ) | $ | 510 | $ | (86 | ) |
(a) | OID = Other (income)/deductions—net, included in Other (income)/deductions—net in the condensed consolidated statements of income. OCI = Other comprehensive income/(loss), included in the condensed consolidated statements of comprehensive income. |
(b) | Also, includes gains and losses attributable to derivative instruments designated and qualifying as fair value hedges, as well as the offsetting gains and losses attributable to the hedged items in such hedging relationships. |
(c) | There was no significant ineffectiveness for any period presented. |
(d) | For derivative financial instruments in cash flow hedge relationships, the effective portion is included in Other comprehensive income/(loss)––Unrealized holding gains/(losses) on derivative financial instruments, net. For derivative financial instruments in net investment hedge relationships and for foreign currency debt designated as hedging instruments, the effective portion is included in Other comprehensive income/(loss)––Foreign currency translation adjustments, net. |
The following table provides the components of Inventories: | ||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | December 31, 2014 | ||||||
Finished goods | $ | 1,824 | $ | 1,905 | ||||
Work-in-process | 3,458 | 3,248 | ||||||
Raw materials and supplies | 514 | 510 | ||||||
Inventories | $ | 5,796 | $ | 5,663 | ||||
Noncurrent inventories not included above(a) | $ | 478 | $ | 425 |
(a) | Included in Other noncurrent assets. There are no recoverability issues associated with these amounts. |
The following table provides the components of Identifiable intangible assets: | ||||||||||||||||||||||||
June 28, 2015 | December 31, 2014 | |||||||||||||||||||||||
(MILLIONS OF DOLLARS) | Gross Carrying Amount | Accumulated Amortization | Identifiable Intangible Assets, less Accumulated Amortization | Gross Carrying Amount | Accumulated Amortization | Identifiable Intangible Assets, less Accumulated Amortization | ||||||||||||||||||
Finite-lived intangible assets | ||||||||||||||||||||||||
Developed technology rights | $ | 70,226 | $ | (45,611 | ) | $ | 24,615 | $ | 70,946 | $ | (44,694 | ) | $ | 26,252 | ||||||||||
Brands | 1,905 | (890 | ) | 1,015 | 1,951 | (855 | ) | 1,096 | ||||||||||||||||
Licensing agreements and other | 1,054 | (902 | ) | 152 | 991 | (832 | ) | 159 | ||||||||||||||||
73,186 | (47,403 | ) | 25,782 | 73,887 | (46,381 | ) | 27,506 | |||||||||||||||||
Indefinite-lived intangible assets | ||||||||||||||||||||||||
Brands and other | 7,208 | 7,208 | 7,273 | 7,273 | ||||||||||||||||||||
In-process research and development | 434 | 434 | 387 | 387 | ||||||||||||||||||||
7,642 | 7,642 | 7,660 | 7,660 | |||||||||||||||||||||
Identifiable intangible assets(a) | $ | 80,827 | $ | (47,403 | ) | $ | 33,424 | $ | 81,547 | $ | (46,381 | ) | $ | 35,166 |
(a) | The decrease in identifiable intangible assets, less accumulated amortization, is primarily related to amortization, partially offset by assets acquired as part of the acquisition of Baxter’s portfolio of marketed vaccines. For information about the assets acquired as part of the acquisition of Baxter’s portfolio of marketed vaccines, see Note 2A. |
Our identifiable intangible assets are associated with the following segments, as a percentage of total identifiable intangible assets, less accumulated amortization: | |||||||||
June 28, 2015 | |||||||||
GIP | VOC | GEP | |||||||
Developed technology rights | 31 | % | 36 | % | 33 | % | |||
Brands, finite-lived | — | % | 80 | % | 20 | % | |||
Brands, indefinite-lived | — | % | 69 | % | 31 | % | |||
In-process research and development | 7 | % | 38 | % | 55 | % |
The following table provides the components of and changes in the carrying amount of Goodwill: | ||||||||||||||||
(MILLIONS OF DOLLARS) | GIP | VOC | GEP | Total | ||||||||||||
Balance, December 31, 2014 | $ | 13,032 | $ | 11,398 | $ | 17,639 | $ | 42,069 | ||||||||
Additions | — | 39 | — | 39 | ||||||||||||
Other(a) | (161 | ) | (156 | ) | (220 | ) | (537 | ) | ||||||||
Balance, June 28, 2015 | $ | 12,871 | $ | 11,281 | $ | 17,419 | $ | 41,571 |
(a) | Primarily reflects the impact of foreign exchange. |
The following table provides the components of net periodic benefit cost: | ||||||||||||||||||||||||||||||||
Pension Plans | ||||||||||||||||||||||||||||||||
U.S. Qualified(a) | U.S. Supplemental (Non-Qualified) | International(b) | Postretirement Plans(c) | |||||||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||||||||||||||
Three Months Ended | ||||||||||||||||||||||||||||||||
Net periodic benefit cost: | ||||||||||||||||||||||||||||||||
Service cost | $ | 72 | $ | 63 | $ | 6 | $ | 5 | $ | 46 | $ | 52 | $ | 14 | $ | 14 | ||||||||||||||||
Interest cost | 168 | 175 | 13 | 14 | 76 | 101 | 32 | 42 | ||||||||||||||||||||||||
Expected return on plan assets | (270 | ) | (262 | ) | — | — | (103 | ) | (116 | ) | (13 | ) | (15 | ) | ||||||||||||||||||
Amortization of: | ||||||||||||||||||||||||||||||||
Actuarial losses | 82 | 15 | 11 | 8 | 31 | 24 | 9 | 2 | ||||||||||||||||||||||||
Prior service credits | (2 | ) | (1 | ) | — | (1 | ) | (2 | ) | (1 | ) | (31 | ) | (15 | ) | |||||||||||||||||
Curtailments | — | — | — | — | — | 16 | (7 | ) | (1 | ) | ||||||||||||||||||||||
Settlements | 19 | 12 | 2 | 5 | 1 | 1 | — | — | ||||||||||||||||||||||||
Special termination benefits | — | — | — | — | — | 3 | — | — | ||||||||||||||||||||||||
$ | 69 | $ | 2 | $ | 32 | $ | 31 | $ | 50 | $ | 80 | $ | 5 | $ | 27 | |||||||||||||||||
Six Months Ended | ||||||||||||||||||||||||||||||||
Net periodic benefit cost: | ||||||||||||||||||||||||||||||||
Service cost | $ | 144 | $ | 127 | $ | 11 | $ | 10 | $ | 94 | $ | 104 | $ | 27 | $ | 28 | ||||||||||||||||
Interest cost | 337 | 350 | 27 | 29 | 155 | 201 | 64 | 84 | ||||||||||||||||||||||||
Expected return on plan assets | (542 | ) | (525 | ) | — | — | (209 | ) | (230 | ) | (26 | ) | (31 | ) | ||||||||||||||||||
Amortization of: | ||||||||||||||||||||||||||||||||
Actuarial losses | 165 | 31 | 23 | 15 | 63 | 49 | 18 | 3 | ||||||||||||||||||||||||
Prior service credits | (3 | ) | (3 | ) | (1 | ) | (1 | ) | (3 | ) | (3 | ) | (62 | ) | (29 | ) | ||||||||||||||||
Curtailments | 1 | 2 | — | — | — | 15 | (17 | ) | (4 | ) | ||||||||||||||||||||||
Settlements | 45 | 21 | 17 | 16 | 1 | 2 | — | — | ||||||||||||||||||||||||
Special termination benefits | — | — | — | — | — | 5 | — | — | ||||||||||||||||||||||||
$ | 147 | $ | 3 | $ | 77 | $ | 69 | $ | 101 | $ | 143 | $ | 6 | $ | 51 |
(a) | The increase in net periodic benefit costs for the three and six months ended June 28, 2015, compared to the three and six months ended June 29, 2014, for our U.S. qualified pension plans was primarily driven by (i) the increase in the amounts amortized for actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation (which increased the amount of deferred actuarial losses) and, to a lesser extent, a 2014 change in mortality assumptions (reflecting a longer life expectancy for plan participants), and (ii) higher settlement activity. The aforementioned increases were partially offset by (i) a greater expected return on plan assets resulting from an increased plan asset base due to a voluntary contribution of $1.0 billion made at the beginning of January 2015, which in turn was partially offset by a decrease in the expected rate of return on plan assets from 8.50% to 8.25%, and (ii) lower interest costs resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
(b) | The decrease in net periodic benefit costs for the three and six months ended June 28, 2015, compared to the three and six months ended June 29, 2014, for our international pension plans was primarily driven by (i) the decrease in interest cost resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation, (ii) a decrease in service cost related to changes in actuarial assumptions (lower inflation and lower rate of wage increases) and the U.K. pension plan freeze in 2014, which offset the impact of the decrease, in 2014, in the discount rate used to determine the benefit obligation (the effect of which is an increase in service costs). The aforementioned decreases to net periodic benefit costs were partially offset by (i) a decrease in the expected return on plan assets due to a lower expected rate of return on plan assets and (ii) an increase in the amounts amortized for actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
(c) | The decrease in net periodic benefit costs for the three and six months ended June 28, 2015, compared to the three and six months ended June 29, 2014, for our postretirement plans was primarily driven by (i) the increase in the amounts amortized for prior service credits and (ii) an increase in curtailment gain resulting from the implementation of changes to certain retiree medical benefits to adopt programs eligible for the Medicare Part D plan subsidy, as allowed under the employer group waiver plan, which was approved and communicated to plan participants, and will go into effect on January 1, 2016, as well as (iii) a decrease in interest cost resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. The aforementioned decreases were partially offset by an increase in actuarial losses resulting from the decrease, in 2014, in the discount rate used to determine the benefit obligation. |
Pension Plans | ||||||||||||||||
(MILLIONS OF DOLLARS) | U.S. Qualified | U.S. Supplemental (Non-Qualified) | International | Postretirement Plans | ||||||||||||
Contributions from/reimbursements of our general assets for the six months ended June 28, 2015(a) | $ | 1,000 | $ | 84 | $ | 117 | $ | (30 | ) | |||||||
Expected contributions from our general assets during 2015(b) | $ | 1,000 | $ | 117 | $ | 237 | $ | 81 |
(a) | Contributions to the postretirement plans were more than offset by reimbursements of approximately $133 million received for eligible 2014 prescription drug expenses for certain retirees. |
(b) | Contributions expected to be made for 2015 are inclusive of amounts contributed during the six months ended June 28, 2015, including the $1.0 billion voluntary contribution that was made in January 2015 for the U.S. Qualified plan. The U.S. supplemental (non-qualified) pension plan, international pension plan and the postretirement plan contributions from our general assets include direct employer benefit payments. |
The following table provides the detailed calculation of Earnings per common share (EPS): | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(IN MILLIONS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
EPS Numerator––Basic | ||||||||||||||||
Income from continuing operations | $ | 2,635 | $ | 2,921 | $ | 5,011 | $ | 5,186 | ||||||||
Less: Net income attributable to noncontrolling interests | 9 | 9 | 14 | 18 | ||||||||||||
Income from continuing operations attributable to Pfizer Inc. | 2,626 | 2,912 | 4,996 | 5,168 | ||||||||||||
Less: Preferred stock dividends––net of tax | — | 1 | 1 | 1 | ||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | 2,625 | 2,911 | 4,996 | 5,167 | ||||||||||||
Discontinued operations––net of tax | 1 | — | 6 | 73 | ||||||||||||
Less: Discontinued operations––net of tax, attributable to noncontrolling interests | — | — | — | — | ||||||||||||
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders | 1 | — | 6 | 73 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 2,626 | $ | 2,911 | $ | 5,002 | $ | 5,240 | ||||||||
EPS Numerator––Diluted | ||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 2,626 | $ | 2,912 | $ | 4,996 | $ | 5,168 | ||||||||
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions | 1 | — | 6 | 73 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 2,626 | $ | 2,912 | $ | 5,002 | $ | 5,241 | ||||||||
EPS Denominator | ||||||||||||||||
Weighted-average number of common shares outstanding––Basic | 6,159 | 6,368 | 6,181 | 6,379 | ||||||||||||
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreement | 83 | 76 | 86 | 81 | ||||||||||||
Weighted-average number of common shares outstanding––Diluted | 6,243 | 6,444 | 6,267 | 6,460 | ||||||||||||
Stock options that had exercise prices greater than the average market price of our common stock issuable under employee compensation plans(a) | 56 | 44 | 45 | 44 |
(a) | These common stock equivalents were outstanding for the six months ended June 28, 2015 and June 29, 2014, but were not included in the computation of diluted EPS for those periods because their inclusion would have had an anti-dilutive effect. |
• | Patent litigation, which typically involves challenges to the coverage and/or validity of our patents on various products, processes or dosage forms. We are the plaintiff in the vast majority of these actions. An adverse outcome in actions in which we are the plaintiff could result in a loss of patent protection for the drug at issue, a significant loss of revenues from that drug and impairments of any associated assets. |
• | Product liability and other product-related litigation, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others, often involves highly complex issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters. |
• | Commercial and other matters, which can include merger-related and product-pricing claims and environmental claims and proceedings, can involve complexities that will vary from matter to matter. |
• | Government investigations, which often are related to the extensive regulation of pharmaceutical companies by national, state and local government agencies in the U.S. and in other countries. |
• | Personal Injury Actions |
• | Antitrust Actions |
• | Whistleblower Action |
• | Antitrust Actions |
• | Personal Injury Actions |
• | Global Innovative Pharmaceutical segment––GIP is focused on developing, registering and commercializing novel, value-creating medicines that significantly improve patients’ lives. These therapeutic areas include inflammation, cardiovascular/metabolic, neuroscience and pain, rare diseases and women’s/men’s health and include leading brands, such as Xeljanz, Eliquis and Lyrica (U.S., Japan). GIP has a pipeline of medicines in inflammation, cardiovascular/metabolic disease, neuroscience and pain, and rare diseases. |
• | Global Vaccines, Oncology and Consumer Healthcare segment––VOC focuses on the development and commercialization of vaccines and products for oncology and consumer healthcare. Consumer Healthcare manufactures and markets several well known, over-the-counter (OTC) products. Each of the three businesses in VOC operates as a separate, global business with distinct specialization in terms of the science and market approach necessary to deliver value to consumers and patients. |
• | Global Established Pharmaceutical segment––GEP includes the brands that have lost market exclusivity and, generally, the mature, patent-protected products that are expected to lose exclusivity through 2015 in most major markets and, to a much smaller extent, generic pharmaceuticals. Additionally, GEP includes our development portfolio of sterile injectable and biosimilar products. |
• | Worldwide Research and Development (WRD), which is generally responsible for research projects until proof-of-concept is achieved and then for transitioning those projects to the appropriate operating segment for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. This organization also has responsibility for certain science-based and other platform-services organizations, which provide technical expertise and other services to the various R&D projects. WRD is also responsible for facilitating all regulatory submissions and interactions with regulatory agencies, including all safety-event activities. |
• | Pfizer Medical, which is responsible for the provision of medical information to healthcare providers, patients and other parties, transparency and disclosure activities, clinical trial results publication, grants for healthcare quality improvement and medical education, partnerships with global public health and medical associations, regulatory inspection readiness reviews, internal audits of Pfizer-sponsored clinical trials and internal regulatory compliance processes. |
• | Corporate, representing platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement) and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. |
• | Other unallocated costs, representing overhead expenses associated with our manufacturing and commercial operations not directly attributable to an operating segment. |
• | Certain transactions and events such as (i) purchase accounting adjustments, where we incur expenses associated with the amortization of fair value adjustments to inventory, intangible assets and property, plant and equipment; (ii) acquisition-related costs, where we incur costs for executing the transaction, integrating the acquired operations and restructuring the combined company; and (iii) certain significant items, which include non-acquisition-related restructuring costs, as well as costs incurred for legal settlements, asset impairments and disposals of assets or businesses, including, as applicable, any associated transition activities. |
The following table provides selected income statement information by reportable segment: | ||||||||||||||||
Revenues | Earnings(a) | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Three Months Ended | ||||||||||||||||
Reportable Segments: | ||||||||||||||||
Global Innovative Pharmaceutical (GIP) | $ | 3,497 | $ | 3,547 | $ | 2,013 | $ | 2,009 | ||||||||
Global Vaccines, Oncology and Consumer Healthcare (VOC) | 3,133 | 2,579 | 1,678 | 1,157 | ||||||||||||
Global Established Pharmaceutical (GEP) | 5,090 | 6,513 | 3,177 | 4,176 | ||||||||||||
Total reportable segments | 11,720 | 12,639 | 6,868 | 7,342 | ||||||||||||
Other business activities(b) | 133 | 63 | (679 | ) | (713 | ) | ||||||||||
Reconciling Items: | ||||||||||||||||
Corporate(c) | — | — | (1,286 | ) | (1,287 | ) | ||||||||||
Purchase accounting adjustments(c) | — | — | (835 | ) | (949 | ) | ||||||||||
Acquisition-related costs(c) | — | — | (68 | ) | (47 | ) | ||||||||||
Certain significant items(d) | — | 71 | (305 | ) | (238 | ) | ||||||||||
Other unallocated | — | — | (156 | ) | (105 | ) | ||||||||||
$ | 11,853 | $ | 12,773 | $ | 3,539 | $ | 4,003 | |||||||||
Six Months Ended | ||||||||||||||||
Reportable Segments: | ||||||||||||||||
Global Innovative Pharmaceutical business (GIP) | $ | 6,572 | $ | 6,623 | $ | 3,524 | $ | 3,776 | ||||||||
Global Vaccines, Oncology and Consumer Healthcare (VOC) | 5,796 | 4,753 | 3,143 | 2,214 | ||||||||||||
Global Established Pharmaceutical business (GEP) | 10,104 | 12,503 | 6,433 | 8,225 | ||||||||||||
Total reportable segments | 22,473 | 23,879 | 13,100 | 14,215 | ||||||||||||
Other business activities(b) | 244 | 119 | (1,348 | ) | (1,380 | ) | ||||||||||
Reconciling Items: | ||||||||||||||||
Corporate(c) | — | — | (2,573 | ) | (2,487 | ) | ||||||||||
Purchase accounting adjustments(c) | — | — | (1,738 | ) | (1,957 | ) | ||||||||||
Acquisition-related costs(c) | — | — | (91 | ) | (77 | ) | ||||||||||
Certain significant items(d) | — | 128 | (532 | ) | (1,254 | ) | ||||||||||
Other unallocated | — | — | (197 | ) | (210 | ) | ||||||||||
$ | 22,717 | $ | 24,126 | $ | 6,621 | $ | 6,850 |
(a) | Income from continuing operations before provision for taxes on income. |
(b) | Other business activities includes the revenues and operating results of Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales operation, which in 2015 includes the revenues and expenses related to our transitional manufacturing and supply agreements with Zoetis. Other business activities also includes the costs managed by our Worldwide Research and Development organization and our Pfizer Medical organization. |
(c) | For a description, see the “Other Costs and Business Activities” section above. |
(d) | Certain significant items are substantive, unusual items that, either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis. |
The following table provides revenues by geographic area: | ||||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
United States | $ | 4,994 | $ | 4,906 | 2 | $ | 9,428 | $ | 9,181 | 3 | ||||||||||||
Developed Europe(a) | 2,380 | 3,008 | (21 | ) | 4,691 | 5,803 | (19 | ) | ||||||||||||||
Developed Rest of World(b) | 1,558 | 1,861 | (16 | ) | 3,050 | 3,589 | (15 | ) | ||||||||||||||
Emerging Markets(c) | 2,921 | 2,998 | (3 | ) | 5,548 | 5,553 | — | |||||||||||||||
Revenues | $ | 11,853 | $ | 12,773 | (7 | ) | $ | 22,717 | $ | 24,126 | (6 | ) |
(a) | Developed Europe region includes the following markets: Western Europe, Finland and the Scandinavian countries. Revenues denominated in euros were $1.8 billion and $2.3 billion in the second quarter of 2015 and 2014, respectively, and $3.6 billion and $4.5 billion in the first six months of 2015 and 2014, respectively. |
(b) | Developed Rest of World region includes the following markets: Australia, Canada, Japan, New Zealand and South Korea. |
(c) | Emerging Markets region includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, the Middle East, Eastern Europe, Africa, Turkey and Central Europe. |
The following table provides detailed revenue information: | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
(MILLIONS OF DOLLARS) | Business(a) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Biopharmaceutical revenues: | |||||||||||||||||
Prevnar family(b) | V | $ | 1,503 | $ | 1,097 | $ | 2,808 | $ | 2,024 | ||||||||
Lyrica(c) | GEP/GIP | 1,219 | 1,315 | 2,406 | 2,465 | ||||||||||||
Enbrel (Outside the U.S. and Canada) | GIP | 822 | 977 | 1,581 | 1,891 | ||||||||||||
Lipitor | GEP | 509 | 543 | 950 | 1,000 | ||||||||||||
Viagra(d) | GEP/GIP | 448 | 427 | 843 | 801 | ||||||||||||
Sutent | O | 294 | 310 | 536 | 578 | ||||||||||||
Zyvox | GEP | 259 | 348 | 530 | 669 | ||||||||||||
Norvasc | GEP | 251 | 282 | 503 | 560 | ||||||||||||
Premarin family | GEP | 259 | 274 | 491 | 522 | ||||||||||||
Celebrex | GEP | 224 | 762 | 428 | 1,386 | ||||||||||||
BeneFIX | GIP | 193 | 227 | 366 | 428 | ||||||||||||
Vfend | GEP | 162 | 221 | 345 | 398 | ||||||||||||
Pristiq | GEP | 177 | 198 | 338 | 370 | ||||||||||||
Chantix/Champix | GIP | 173 | 170 | 332 | 317 | ||||||||||||
Genotropin | GIP | 167 | 194 | 306 | 360 | ||||||||||||
Refacto AF/Xyntha | GIP | 142 | 171 | 262 | 316 | ||||||||||||
Xalkori | O | 119 | 108 | 230 | 196 | ||||||||||||
Xeljanz | GIP | 128 | 68 | 224 | 120 | ||||||||||||
Medrol | GEP | 113 | 115 | 215 | 221 | ||||||||||||
Inlyta | O | 111 | 101 | 206 | 189 | ||||||||||||
Xalatan/Xalacom | GEP | 99 | 128 | 201 | 247 | ||||||||||||
Zoloft | GEP | 93 | 104 | 179 | 205 | ||||||||||||
Sulperazon | GEP | 80 | 92 | 179 | 180 | ||||||||||||
Ibrance | O | 140 | — | 178 | — | ||||||||||||
Relpax | GEP | 82 | 98 | 162 | 185 | ||||||||||||
Fragmin | GEP | 88 | 95 | 162 | 176 | ||||||||||||
EpiPen | GEP | 85 | 89 | 161 | 152 | ||||||||||||
Zithromax/Zmax | GEP | 68 | 76 | 154 | 168 | ||||||||||||
Tygacil | GEP | 77 | 82 | 150 | 156 | ||||||||||||
Effexor | GEP | 74 | 96 | 147 | 178 | ||||||||||||
Toviaz | GIP | 71 | 79 | 134 | 142 | ||||||||||||
Revatio | GEP | 65 | 68 | 128 | 144 | ||||||||||||
BMP2 | GIP | 75 | 51 | 113 | 90 | ||||||||||||
Xanax/Xanax XR | GEP | 54 | 68 | 109 | 127 | ||||||||||||
Cardura | GEP | 55 | 68 | 106 | 134 | ||||||||||||
Rapamune | GIP | 53 | 87 | 106 | 175 | ||||||||||||
Unasyn | GEP | 50 | 54 | 105 | 100 | ||||||||||||
Somavert | GIP | 55 | 59 | 104 | 109 | ||||||||||||
Neurontin | GEP | 48 | 58 | 103 | 107 | ||||||||||||
Depo-Provera | GEP | 51 | 40 | 88 | 93 | ||||||||||||
FSME-IMMUN/TicoVac | V | 56 | — | 65 | — | ||||||||||||
Alliance revenues(e) | GEP/GIP | 311 | 235 | 533 | 448 | ||||||||||||
All other GIP | GIP | 87 | 131 | 178 | 237 | ||||||||||||
All other GEP | GEP | 1,623 | 1,910 | 3,256 | 3,749 | ||||||||||||
All other V/O | V/O | 70 | 51 | 124 | 93 | ||||||||||||
Total biopharmaceutical revenues | GEP/GIP/V/O | 10,880 | 11,727 | 20,824 | 22,206 | ||||||||||||
Other revenues: | |||||||||||||||||
Consumer Healthcare | C | 840 | 912 | 1,648 | 1,673 | ||||||||||||
Other(f) | 133 | 134 | 244 | 247 | |||||||||||||
Revenues | $ | 11,853 | $ | 12,773 | $ | 22,717 | $ | 24,126 |
(a) | Indicates the business to which the revenues relate. GIP = the Global Innovative Pharmaceutical segment; V = the Global Vaccines |
(b) | In the second quarter and the first six months of 2015, all revenues were composed of Prevnar 13/Prevenar 13. In the second quarter and the first six months of 2014, revenues were composed of the Prevnar family of products, which included Prevnar 13/Prevenar 13 and, to a much lesser extent, Prevenar (7-valent). |
(c) | Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in GEP. All other Lyrica revenues are included in GIP. |
(d) | Viagra revenues from the U.S. and Canada are included in GIP. All other Viagra revenues are included in GEP. |
(e) | Includes Eliquis (GIP), Rebif (GIP), Spiriva (GEP) and Aricept (GEP). |
(f) | Other includes revenues generated from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and revenues related to our transitional manufacturing and supply agreements with Zoetis. |
ñ | Beginning on page 40 | ||||
This section provides information about the following: our business; our performance during the second quarter and first six months of 2015 and 2014; our operating environment; our strategy; our business development initiatives, such as acquisitions, dispositions, licensing and collaborations; and our financial guidance for 2015. | |||||
ñ | Beginning on page 50 | ||||
This section includes a Revenues Overview section as well as the following sub-sections: | |||||
Beginning on page 53 | |||||
This sub-section provides revenue information for several of our major biopharmaceutical products. | |||||
Beginning on page 54 | |||||
This sub-section provides an overview of several of our biopharmaceutical products. | |||||
Beginning on page 58 | |||||
This sub-section provides an overview of important biopharmaceutical product developments. | |||||
Beginning on page 60 | |||||
This sub-section provides a discussion about our costs and expenses. | |||||
Beginning on page 63 | |||||
This sub-section provides a discussion of items impacting our tax provisions. | |||||
Beginning on page 63 | |||||
This sub-section provides a discussion of an alternative view of performance used by management. | |||||
ñ | Beginning on page 68 | ||||
This section provides a discussion of the performance of each of our operating segments. | |||||
ñ | Beginning on page 74 | ||||
This section provides a discussion of changes in certain components of other comprehensive income. | |||||
ñ | Beginning on page 75 | ||||
This section provides a discussion of changes in certain balance sheet accounts, including Accumulated other comprehensive loss. | |||||
ñ | Beginning on page 76 | ||||
This section provides an analysis of our cash flows for the first six months of 2015 and 2014. | |||||
ñ | Beginning on page 77 | ||||
This section provides an analysis of selected measures of our liquidity and of our capital resources as of June 28, 2015 and December 31, 2014, as well as a discussion of our outstanding debt and other commitments that existed as of June 28, 2015 and December 31, 2014. Included in the discussion of outstanding debt is a discussion of the amount of financial capacity available to help fund Pfizer’s future activities. | |||||
ñ | Beginning on page 80 | ||||
This section discusses accounting standards that we have recently adopted, as well as those that recently have been issued, but not yet adopted. | |||||
ñ | Beginning on page 81 | ||||
This section provides a description of the risks and uncertainties that could cause actual results to differ materially from those discussed in forward-looking statements presented in this MD&A, relating to, among other things, our anticipated operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, and plans relating to share repurchases and dividends. Such forward-looking statements are based on management’s plans and assumptions, which are inherently susceptible to uncertainty and changes in circumstances. |
The following table provides the components of the condensed consolidated statements of income: | ||||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS, EXCEPT PER COMMON SHARE DATA) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Revenues | $ | 11,853 | $ | 12,773 | (7 | ) | $ | 22,717 | $ | 24,126 | (6 | ) | ||||||||||
Cost of sales | 2,180 | 2,462 | (11 | ) | 4,018 | 4,507 | (11 | ) | ||||||||||||||
% of revenues | 18.4 | % | 19.3 | % | 17.7 | % | 18.7 | % | ||||||||||||||
Selling, informational and administrative expenses | 3,386 | 3,520 | (4 | ) | 6,491 | 6,560 | (1 | ) | ||||||||||||||
% of revenues | 28.6 | % | 27.6 | % | 28.6 | % | 27.2 | % | ||||||||||||||
Research and development expenses | 1,734 | 1,759 | (1 | ) | 3,620 | 3,382 | 7 | |||||||||||||||
% of revenues | 14.6 | % | 13.8 | % | 15.9 | % | 14.0 | % | ||||||||||||||
Amortization of intangible assets | 872 | 1,001 | (13 | ) | 1,811 | 2,118 | (14 | ) | ||||||||||||||
% of revenues | 7.4 | % | 7.8 | % | 8.0 | % | 8.8 | % | ||||||||||||||
Restructuring charges and certain acquisition-related costs | 86 | 81 | 6 | 146 | 139 | 5 | ||||||||||||||||
% of revenues | 0.7 | % | 0.6 | % | 0.6 | % | 0.6 | % | ||||||||||||||
Other (income)/deductions––net | 55 | (53 | ) | * | 9 | 570 | (98 | ) | ||||||||||||||
Income from continuing operations before provision for taxes on income | 3,539 | 4,003 | (12 | ) | 6,621 | 6,850 | (3 | ) | ||||||||||||||
% of revenues | 29.9 | % | 31.3 | % | 29.1 | % | 28.4 | % | ||||||||||||||
Provision for taxes on income | 905 | 1,082 | (16 | ) | 1,610 | 1,664 | (3 | ) | ||||||||||||||
Effective tax rate | 25.6 | % | 27.0 | % | 24.3 | % | 24.3 | % | ||||||||||||||
Income from continuing operations | 2,635 | 2,921 | (10 | ) | 5,011 | 5,186 | (3 | ) | ||||||||||||||
% of revenues | 22.2 | % | 22.9 | % | 22.1 | % | 21.5 | % | ||||||||||||||
Discontinued operations––net of tax | 1 | — | * | 6 | 73 | (92 | ) | |||||||||||||||
Net income before allocation to noncontrolling interests | 2,635 | 2,921 | (10 | ) | 5,017 | 5,259 | (5 | ) | ||||||||||||||
% of revenues | 22.2 | % | 22.9 | % | 22.1 | % | 21.8 | % | ||||||||||||||
Less: Net income attributable to noncontrolling interests | 9 | 9 | (5 | ) | 14 | 18 | (21 | ) | ||||||||||||||
Net income attributable to Pfizer Inc. | $ | 2,626 | $ | 2,912 | (10 | ) | $ | 5,002 | $ | 5,241 | (5 | ) | ||||||||||
% of revenues | 22.2 | % | 22.8 | % | 22.0 | % | 21.7 | % | ||||||||||||||
Earnings per common share––basic: | ||||||||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.43 | $ | 0.46 | (7 | ) | $ | 0.81 | $ | 0.81 | — | |||||||||||
Discontinued operations––net of tax | — | — | — | — | 0.01 | (100 | ) | |||||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.43 | $ | 0.46 | (7 | ) | $ | 0.81 | $ | 0.82 | (1 | ) | ||||||||||
Earnings per common share––diluted: | ||||||||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.42 | $ | 0.45 | (7 | ) | $ | 0.80 | $ | 0.80 | — | |||||||||||
Discontinued operations––net of tax | — | — | — | — | 0.01 | (100 | ) | |||||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.42 | $ | 0.45 | (7 | ) | $ | 0.80 | $ | 0.81 | (1 | ) | ||||||||||
Cash dividends paid per common share | $ | 0.28 | $ | 0.26 | 8 | $ | 0.56 | $ | 0.52 | 8 |
• | the performance of several key products in developed markets, including Prevnar 13 primarily in adults (primarily in the U.S.), Eliquis, Lyrica (GIP) (primarily in the U.S. and Japan), Xeljanz (primarily in the U.S), Viagra (GIP) and Ibrance (in the U.S.), as well as from vaccines acquired in December 2014 from Baxter International Inc. (Baxter) (collectively, up approximately $950 million); and |
• | a 6% operational increase in revenues in emerging markets, reflecting continued strong operational growth primarily from Lipitor and Prevenar 13 (collectively, up approximately $135 million), |
• | the loss of exclusivity and immediate multi-source generic competition for Celebrex in the U.S. in December 2014 (down approximately $460 million); |
• | the loss of exclusivity for Zyvox in the U.S. in the first half of 2015, Lyrica (GEP) in certain developed Europe markets, beginning in the first quarter of 2015, Celebrex in Canada, developed Europe, Australia and New Zealand, Rapamune in the U.S., Inspra in developed Europe, and Viagra (GEP) (international developed markets) (collectively, down approximately $290 million) and the loss of exclusivity for certain other products (collectively, down approximately $60 million); |
• | the performance of certain other products such as Lipitor in developed markets and Nexium 24HR and Geodon in the U.S. (collectively, down approximately $170 million); and |
• | the termination of the Spiriva co-promotion collaboration in certain countries (down approximately $30 million). |
• | the performance of several key products in developed markets, including Prevnar 13 primarily in adults (primarily in the U.S.), Eliquis, Lyrica (GIP) (primarily in the U.S. and Japan), Xeljanz (primarily in the U.S.), Viagra (GIP) and Ibrance (in the U.S.), as well as from vaccines acquired in December 2014 from Baxter (collectively, up approximately $1.7 billion); and |
• | a 9% operational increase in revenues in emerging markets, reflecting continued strong operational growth, primarily from Lipitor, Prevenar 13, Zyvox and Viagra (in China) (collectively, up approximately $320 million), |
• | the loss of exclusivity and immediate multi-source generic competition for Celebrex in the U.S. in December 2014 (down approximately $840 million); |
• | the loss of exclusivity for Zyvox in the U.S. in the first half of 2015, Lyrica (GEP) in certain developed Europe markets beginning in the first quarter of 2015, Celebrex in Canada, developed Europe, Australia and New Zealand, Rapamune in the U.S., Inspra in developed Europe, Viagra (GEP) (international developed markets) and Aricept in Canada (collectively, down approximately $490 million), and the loss of exclusivity for certain other products (collectively, down approximately $80 million); |
• | the performance of certain other products such as Lipitor in developed markets, BeneFIX and Geodon in the U.S., and Norvasc in Japan (collectively, down approximately $260 million); and |
• | the termination of the Spiriva co-promotion collaboration in certain countries (down approximately $100 million). |
• | higher legal charges (up $101 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net), |
• | lower cost of sales (down $282 million) (see also the “Costs and Expenses––Cost of Sales” section of this MD&A); |
• | lower amortization of intangible assets (down $129 million) (see also the “Costs and Expenses––Amortization of Intangible Assets ” section of this MD&A); |
• | a lower effective tax rate (down 1.5 percentage points to 25.6%) (see also the “Provision for Taxes on Income” section of this MD&A and Notes to Condensed Consolidated Financial Statements––Note 5. Tax Matters); |
• | lower selling, informational and administrative expenses (down $134 million) (see also the “Costs and Expenses––Selling, Informational and Administrative Expenses (SI&A) Expenses” section of this MD&A); and |
• | lower net interest expense (down $80 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net). |
• | higher research and development expenses (up $238 million) (see also the “Costs and Expenses––Research and Development (R&D) Expenses” section of this MD&A); and |
• | higher charges for business and legal entity alignment activities (up $97 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net), |
• | lower legal charges (down $593 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net); |
• | lower cost of sales (down $489 million) (see also the “Costs and Expenses––Cost of Sales” section of this MD&A); |
• | lower amortization of intangible assets (down $307 million) (see also the “Costs and Expenses––Amortization of Intangible Assets” section of this MD&A); |
• | lower net interest expense (down $93 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net); |
• | lower asset impairments (down $90 million) (see also the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net); and |
• | lower selling, informational and administrative expenses (down $69 million) (see also the “Costs and Expenses––Selling, Information and Administrative Expenses (SI&A) Expenses” section of this MD&A). |
• | $203 million in the second quarter of 2015 and $30 million in the second quarter of 2014, and $437 million in the first six months of 2015 and $205 million in the first six months of 2014, recorded as a reduction to Revenues, related to the higher, extended and expanded rebate provisions and the Medicare “coverage gap” discount provision; and |
• | $56 million in the second quarter of 2015 and $54 million in the second quarter of 2014, and $89 million in the first six months of 2015 and $25 million in the first six months of 2014, recorded in Selling, informational and administrative expenses, related to the fee payable to the federal government (which is not deductible for U.S. income tax purposes) based on our prior-calendar-year share relative to other companies of branded prescription drug sales to specified government programs. The increase in the first six months of 2015 was primarily a result of a decrease in the favorable true-up in the first six months of 2015, compared to the favorable true-up in the first six months of 2014, associated with the final invoice for the respective prior-calendar year received from the federal government, which reflected a lower share than that of the initial invoice. |
• | We believe that patients, who are experiencing increases in co-pays and restrictions on access to medicines as payers seek to control costs, sometimes switch to generic products, delay treatments, skip doses or use less effective treatments. We are exposed to negative pricing pressure in various markets around the world. The U.S. has highly competitive insurance markets, and Europe, Japan, China, Canada, South Korea and a number of other international markets have government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs for the government-sponsored healthcare system, particularly under recent global pressures. Furthermore, some government agencies and third-party payers use health technology assessments in ways that, at times, lead to restricted access to and lower prices for new medicines. |
• | We continue to monitor developments regarding government and government agency receivables in several European markets, including Greece, where economic conditions remain challenging and uncertain. For further information about our Accounts Receivable, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this MD&A. |
• | Significant portions of our revenues and earnings, as well as our substantial international assets, are exposed to changes in foreign exchange rates. We seek to manage our foreign exchange risk in part through operational means, including managing same-currency revenues in relation to same-currency costs and same-currency assets in relation to same-currency liabilities. Depending on market conditions, foreign exchange risk also is managed through the use of derivative financial instruments and foreign currency debt. As we operate in multiple foreign currencies, including the euro, the Japanese yen, the Chinese renminbi, the U.K. pound, the Canadian dollar and approximately 100 other currencies, changes in those currencies relative to the U.S. dollar will impact our revenues and expenses. If the U.S. dollar were to weaken against another currency, assuming all other variables remained constant, our revenues would increase, having a positive impact on earnings, and our overall expenses would increase, having a negative impact on earnings. Conversely, if the U.S. dollar were to strengthen against another currency, assuming all other variables remained constant, our revenues would decrease, having |
• | Global Innovative Pharmaceutical segment––GIP is focused on developing, registering and commercializing novel, value-creating medicines that significantly improve patients’ lives. These therapeutic areas include inflammation, cardiovascular/metabolic, neuroscience and pain, rare diseases and women’s/men’s health and include leading brands, such as Xeljanz, Eliquis and Lyrica (U.S. and Japan). GIP has a pipeline of medicines in inflammation, cardiovascular/metabolic disease, neuroscience and pain, and rare diseases. |
• | Global Vaccines, Oncology and Consumer Healthcare segment––VOC focuses on the development and commercialization of vaccines and products for oncology and consumer healthcare. Consumer Healthcare manufactures and markets several well known, over-the-counter (OTC) products. Each of the three businesses in VOC operates as a separate, global business with distinct specialization in terms of the science and market approach necessary to deliver value to consumers and patients. |
• | Global Established Pharmaceutical segment––GEP includes the brands that have lost market exclusivity and, generally, the mature, patent-protected products that are expected to lose exclusivity through 2015 in most major markets and, to a much smaller extent, generic pharmaceuticals. Additionally, GEP includes our development portfolio of sterile injectable and biosimilar products. |
• | Agreement to Acquire Nimenrix and Mencevax Vaccines from GlaxoSmithKline plc (GSK)––On June 22, 2015, we announced that we entered into an agreement with GSK to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for total consideration of approximately $130 million (€115 million). This transaction will add two high-quality and complementary vaccines to our portfolio, allowing us to reach a broader global population. We do not expect this transaction to have any significant impact on our 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to close in the second half of 2015. |
• | Acquisition of a Minority Interest in AM-Pharma B.V. (AM-Pharma)––On April 9, 2015, we acquired a minority equity interest in AM-Pharma, a privately held Dutch biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon delivery of the clinical trial report after completion of a Phase II trial of recAP in the treatment of Acute Kidney Injury related to sepsis. Results from the current Phase II trial for recAP are expected in the second half of 2016. Under the terms of the agreement, we paid $87.5 million for both the exclusive option and the minority equity interest, which was recorded as a cost-method investment in Long-term investments, and we may make additional payments of up to $512.5 million upon exercise of the option and potential launch of any product that may result from this investment. |
• | Agreement to Acquire Hospira, Inc. (Hospira)––On February 5, 2015, we announced that we entered into a definitive merger agreement under which we agreed to acquire Hospira, the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 per share in cash, for a total enterprise value of approximately $17 billion. We expect to finance the transaction through a combination of existing cash and new debt, with approximately two-thirds of the value financed from cash and one-third from debt. The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions, and is expected to close in the second half of 2015. On May 13, 2015, Hospira shareholders voted in favor of the proposal to adopt the merger agreement, which was also a condition to closing the transaction. On August 4, 2015, the European Commission approved the transaction under the EU Merger Regulation. The European Commission’s decision includes our commitment to divest certain assets in the EU. |
• | Collaboration with OPKO Health, Inc. (OPKO)––On December 13, 2014, we entered into a collaborative agreement with OPKO to develop and commercialize OPKO’s long-acting human growth hormone (hGH-CTP) for the treatment of growth |
• | Acquisition of Marketed Vaccines Business of Baxter International Inc. (Baxter)––On December 1, 2014 (which falls in the first fiscal quarter of 2015 for our international operations), we completed the acquisition of Baxter’s portfolio of marketed vaccines for a final purchase price of $648 million. The portfolio that was acquired consists of NeisVac-C and FSME-IMMUN/TicoVac. NeisVac-C is a vaccine that helps protect against meningitis caused by group C meningococcal meningitis and FSME-IMMUN/TicoVac is a vaccine that helps protect against tick-borne encephalitis. |
• | Collaboration with Merck KGaA––On November 17, 2014, we entered into a collaborative agreement with Merck KGaA, to jointly develop and commercialize avelumab, an investigational anti-PD-L1 antibody currently in development as a potential treatment for multiple types of cancer. We and Merck KGaA are exploring the therapeutic potential of this novel anti-PD-L1 antibody as a single agent as well as in various combinations with our and Merck KGaA’s broad portfolio of approved and investigational oncology therapies. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, in 2015. These clinical development programs include up to six trials (Phase 2 or 3) that could be pivotal for potential product registrations. We and Merck KGaA are also combining resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1 trials. Under the terms of the agreement, in the fourth quarter of 2014, we made an upfront payment of $850 million to Merck KGaA and Merck KGaA is eligible to receive regulatory and commercial milestone payments of up to approximately $2.0 billion. Both companies will jointly fund all development and commercialization costs, and split equally any profits generated from selling any anti-PD-L1 or anti-PD-1 products from this collaboration. Also, as part of the agreement, we gave Merck KGaA certain co-promotion rights for Xalkori in the U.S. and several other key markets. In 2014, we recorded $1.2 billion of Research and development expenses associated with this collaborative arrangement, composed of the $850 million upfront cash payment as well as an additional amount of $309 million, reflecting the estimated fair value of the co-promotion rights given to Merck KGaA. |
• | Acquisition of InnoPharma, Inc. (InnoPharma)––On September 24, 2014, we completed our acquisition of InnoPharma, a privately held pharmaceutical development company, for an upfront cash payment of $225 million and contingent milestone payments of up to $135 million. |
• | License from Cellectis SA (Cellectis)––On June 18, 2014, we entered into a global arrangement with Cellectis to develop Chimeric Antigen Receptor T-cell immunotherapies in the field of oncology directed at select cellular surface antigen targets. In August 2014, we made an upfront payment of $80 million to Cellectis, which was recorded in Research and development expenses. We will also fund R&D costs associated with 15 Pfizer-selected targets and, for the benefit of Cellectis, a portion of the R&D costs associated with four Cellectis-selected targets within the arrangement. Cellectis is eligible to receive development, regulatory and commercial milestone payments of up to $185 million per product that results from the Pfizer-selected targets. Cellectis is also eligible to receive tiered royalties on net sales of any products that are commercialized by Pfizer. |
• | Collaboration with Eli Lilly & Company (Lilly)––In October 2013, we entered into a collaboration agreement with Lilly to jointly develop and globally commercialize Pfizer’s tanezumab, which provides that Pfizer and Lilly will equally share product-development expenses as well as potential revenues and certain product-related costs. On March 23, 2015, Pfizer and Lilly announced that the companies are preparing to resume the Phase 3 clinical program for tanezumab. As a result, on March 27, 2015, we received a $200 million upfront payment from Lilly in accordance with the collaboration agreement between Pfizer and Lilly, which is recorded as deferred income in our condensed consolidated balance sheet and is being recognized into Other (income)/deductions––net over a multi-year period beginning in the second quarter of 2015. This announcement followed a decision by the U.S. Food and Drug Administration (FDA) to lift the partial clinical hold on the tanezumab development program after a review of nonclinical data characterizing the sympathetic nervous system response |
• | License of Nexium OTC Rights––In August 2012, we entered into an agreement with AstraZeneca PLC (AstraZeneca) for the exclusive, global, OTC rights for Nexium, a leading prescription drug approved to treat the symptoms of gastroesophageal reflux disease. In connection with this Consumer Healthcare licensing agreement, we made an upfront payment of $250 million to AstraZeneca, which was recorded in Research and development expenses in our consolidated statement of income for the year ended December 31, 2012. On May 27, 2014, we launched Nexium 24HR in the U.S., and on July 11, 2014, we paid AstraZeneca a related $200 million product launch milestone payment; and on August 1, 2014, we launched Nexium Control in Europe, and on September 15, 2014, we paid AstraZeneca a related $50 million product launch milestone payment. These post-approval milestone payments were recorded in Identifiable intangible assets, less accumulated amortization in the consolidated balance sheet and are being amortized over the estimated useful life of the Nexium brand. AstraZeneca is eligible to receive additional milestone payments of up to $300 million, based on the level of worldwide sales as well as royalty payments, based on worldwide sales. |
The following table provides our financial guidance for full year 2015(a), (b): | |
Reported revenues | $45.0 to $46.0 billion |
(previously $44.0 to $46.0 billion) | |
Adjusted cost of sales as a percentage of reported revenues | 18.0% to 18.5% |
(previously 18.5% to 19.5%) | |
Adjusted selling, informational and administrative expenses | $12.8 to $13.8 billion |
Adjusted research and development expenses | $7.3 to $7.6 billion |
(previously $6.9 to $7.4 billion) | |
Adjusted other (income)/deductions | Approximately ($500 million) of income |
Effective tax rate on adjusted income | Approximately 25.0% |
Reported diluted Earnings per Share (EPS) | $1.38 to $1.47 |
(previously $1.32 to $1.47) | |
Adjusted diluted EPS | $2.01 to $2.07 |
(previously $1.95 to $2.05) |
The following table provides a reconciliation of 2015 Adjusted income and Adjusted diluted EPS guidance to the 2015 Reported net income attributable to Pfizer Inc. and Reported diluted EPS attributable to Pfizer Inc. common shareholders guidance: | ||||
Full-Year 2015 Guidance(a), (b) | ||||
(BILLIONS OF DOLLARS, EXCEPT PER SHARE AMOUNTS) | Net Income | Diluted EPS | ||
Adjusted income/diluted EPS guidance(b) | $12.6 - $13.0 | $2.01 - $2.07 | ||
Purchase accounting impacts of transactions completed as of June 28, 2015 | (2.6) | (0.41) | ||
Restructuring and implementation costs | (0.7) - (0.9) | (0.11) - (0.14) | ||
Business and legal entity alignment costs | (0.3) | (0.05) | ||
Certain other items incurred through June 28, 2015(c) | (0.2) | (0.03) | ||
Reported net income attributable to Pfizer Inc./diluted EPS guidance | $8.6 - $9.2 | $1.38 - $1.47 |
(a) | The 2015 financial guidance reflects the following: |
• | Does not assume the completion of any business development transactions not completed as of June 28, 2015, including any one-time upfront payments associated with such transactions. Our 2015 financial guidance does not reflect any impact from our pending acquisition of Hospira, which is expected to close during the second half of 2015. |
• | Excludes the potential effects of the resolution of litigation-related matters not substantially resolved as of June 28, 2015. |
• | Exchange rates assumed are a blend of the actual exchange rates in effect through the second quarter of 2015 and the mid-July 2015 exchange rates for the remainder of the year. Excludes the impact of a potential devaluation of the Venezuelan bolivar. |
• | Guidance for reported revenues reflects the anticipated negative impact of $3.4 billion due to recent and expected generic competition for certain products that have recently lost or are anticipated to soon lose patent protection, partially offset by anticipated revenue growth from certain other products. |
• | Guidance for reported revenues also reflects the anticipated negative impact of approximately $3.3 billion as a result of unfavorable changes in essentially all foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2014. |
• | Guidance for the effective tax rate on Adjusted income does not assume the renewal of the U.S. research and development (R&D) tax credit. The renewal of the U.S. R&D tax credit is not anticipated to have a material impact on the effective tax rate on Adjusted income. |
• | Guidance for reported and adjusted diluted EPS assumes diluted weighted-average shares outstanding of approximately 6.25 billion shares, inclusive of share repurchases in 2015. Share repurchases in 2015 were composed of $1.0 billion of shares repurchased through January 30, 2015, a $5.0 billion accelerated share repurchase agreement executed in February 2015 and a $0.2 billion cash payment in July 2015 to satisfy the settlement terms of the accelerated share repurchase agreement. Pfizer elected to settle the terms of the accelerated share repurchase agreement with cash as opposed to the commensurate value in shares. Actual and projected dilution related to employee compensation programs is expected to partially offset these share repurchases. |
(b) | For an understanding of Adjusted income and its components and Adjusted diluted EPS (all of which are non-GAAP financial measures), see the “Adjusted Income” section of this MD&A. |
The following table provides worldwide revenues by operating segment and geographic area: | |||||||||||||||||||||||||||||||||
Worldwide | U.S. | International | World- wide | U.S. | Inter- national | ||||||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | Jun 28, 2015 | Jun 29, 2014 | Jun 28, 2015 | Jun 29, 2014 | Jun 28, 2015 | Jun 29, 2014 | % Change in Revenues | ||||||||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||||||||||||||
Operating Segments(a): | |||||||||||||||||||||||||||||||||
GIP | $ | 3,497 | $ | 3,547 | $ | 1,766 | $ | 1,614 | $ | 1,731 | $ | 1,933 | (1 | ) | 9 | (10 | ) | ||||||||||||||||
VOC | 3,133 | 2,579 | 1,694 | 1,136 | 1,439 | 1,443 | 21 | 49 | — | ||||||||||||||||||||||||
GEP | 5,090 | 6,513 | 1,477 | 2,105 | 3,613 | 4,408 | (22 | ) | (30 | ) | (18 | ) | |||||||||||||||||||||
11,720 | 12,639 | 4,936 | 4,855 | 6,784 | 7,784 | (7 | ) | 2 | (13 | ) | |||||||||||||||||||||||
Other(b) | 133 | 134 | 58 | 51 | 75 | 83 | — | 15 | (10 | ) | |||||||||||||||||||||||
Total revenues | $ | 11,853 | $ | 12,773 | $ | 4,994 | $ | 4,906 | $ | 6,859 | $ | 7,867 | (7 | ) | 2 | (13 | ) | ||||||||||||||||
Six Months Ended | |||||||||||||||||||||||||||||||||
Operating Segments(a): | |||||||||||||||||||||||||||||||||
GIP | $ | 6,572 | $ | 6,623 | $ | 3,256 | $ | 2,941 | $ | 3,316 | $ | 3,682 | (1 | ) | 11 | (10 | ) | ||||||||||||||||
VOC | 5,796 | 4,753 | 3,176 | 2,137 | 2,621 | 2,616 | 22 | 49 | — | ||||||||||||||||||||||||
GEP | 10,104 | 12,503 | 2,888 | 4,009 | 7,216 | 8,494 | (19 | ) | (28 | ) | (15 | ) | |||||||||||||||||||||
22,473 | 23,879 | 9,320 | 9,087 | 13,153 | 14,792 | (6 | ) | 3 | (11 | ) | |||||||||||||||||||||||
Other(b) | 244 | 247 | 108 | 94 | 136 | 153 | (1 | ) | 15 | (11 | ) | ||||||||||||||||||||||
Total revenues | $ | 22,717 | $ | 24,126 | $ | 9,428 | $ | 9,181 | $ | 13,289 | $ | 14,945 | (6 | ) | 3 | (11 | ) |
(a) | GIP = the Global Innovative Pharmaceutical segment; VOC = the Global Vaccines, Oncology and Consumer Healthcare segment; and GEP = the Global Established Pharmaceutical segment. |
(b) | Includes revenues generated from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and also includes the revenues related to our transitional manufacturing and supply agreements with Zoetis, Inc. (Zoetis). |
• | in the U.S., revenues increased $88 million, or 2%, in the second quarter of 2015, and increased $247 million, or 3%, in the first six months of 2015, compared to the same periods in 2014, reflecting, among other things: |
◦ | the performance of several key products, including Prevnar 13 primarily in adults, Ibrance (which was launched in the U.S. in February 2015), Eliquis, Xeljanz, Lyrica, Viagra and Celecoxib (collectively, up approximately $790 million in the second quarter of 2015 and $1.5 billion in the first six months of 2015), |
◦ | losses of exclusivity and immediate multi-source generic competition for Celebrex in the U.S. in December 2014 (down approximately $460 million in the second quarter of 2015 and $840 million in the first six months of 2015); |
◦ | the loss of exclusivity for Zyvox and Rapamune, as well as the termination of our Spiriva co-promotion collaboration (collectively, down approximately $140 million in the second quarter of 2015 and $280 million in the first six months of 2015); and |
◦ | the performance of certain other products such as Lipitor, Geodon and BeneFIX, as well as the non-recurrence in 2015 of initial retailer stocking associated with the launch of Nexium 24HR in May 2014 (collectively, down approximately $170 million in the second quarter of 2015 and $160 million in the first six months of 2015). |
• | in our international markets, revenues decreased $1.0 billion, or 13%, in the second quarter of 2015, and decreased $1.7 billion, or 11%, in the first six months of 2015, compared to the same periods in 2014. Foreign exchange unfavorably impacted international revenues by approximately $1.0 billion, or 13%, in the second quarter of 2015 and unfavorably impacted international revenues by approximately $1.8 billion, or 12%, in the first six months of 2015. Operationally, |
◦ | the operational growth in emerging markets of Prevenar 13, Lipitor, Zyvox, Viagra (GEP) and Norvasc (collectively, up approximately $200 million in the second quarter of 2015 and $400 million in the first six months of 2015); and |
◦ | higher revenues in developed markets for Eliquis and Lyrica (GIP), as well as from vaccines acquired in December 2014 from Baxter (in Europe) (collectively, up approximately $190 million in the second quarter of 2015 and $300 million in the first six months of 2015), |
◦ | lower revenues for Lyrica (GEP), Celebrex, Inspra and Viagra (GEP) as a result of the loss of exclusivity, as well as Lipitor, Norvasc, and for the first six months of 2015, Enbrel in developed markets, and Vfend and Zosyn/Tazocin in emerging markets (collectively, down approximately $280 million in the second quarter of 2015 and $460 million in the first six months of 2015). |
The following table provides information about deductions from revenues: | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Medicare rebates(a) | $ | 228 | $ | 265 | $ | 449 | $ | 505 | ||||||||
Medicaid and related state program rebates(a) | 291 | 48 | 571 | 220 | ||||||||||||
Performance-based contract rebates(a), (b) | 581 | 558 | 1,046 | 1,071 | ||||||||||||
Chargebacks(c) | 1,208 | 959 | 2,251 | 1,792 | ||||||||||||
Sales allowances(d) | 990 | 1,040 | 1,894 | 1,981 | ||||||||||||
Sales returns and cash discounts | 366 | 330 | 627 | 572 | ||||||||||||
Total(e) | $ | 3,665 | $ | 3,200 | $ | 6,839 | $ | 6,141 |
(a) | Rebates are product-specific and, therefore, for any given year are impacted by the mix of products sold. |
(b) | Performance-based contract rebates include contract rebates with managed care customers within the U.S., including health maintenance organizations and pharmacy benefit managers, who receive rebates based on the achievement of contracted performance terms and claims under these contracts. Outside the U.S., performance-based contract rebates include rebates to wholesalers/distributors based on achievement of contracted performance for specific products or sales milestones. |
(c) | Chargebacks primarily represent reimbursements to U.S. wholesalers for honoring contracted prices to third parties. |
(d) | Sales allowances primarily represent price reductions that are contractual or legislatively mandated outside the U.S., discounts and distribution fees. |
(e) | For the three months ended June 28, 2015, associated with the following segments: GIP ($1.0 billion); VOC ($0.4 billion); and GEP ($2.3 billion). For the three months ended June 29, 2014, associated with the following segments: GIP ($0.7 billion); VOC ($0.3 billion); and GEP ($2.2 billion). For the six months ended June 28, 2015, associated with the following segments: GIP ($1.9 billion); VOC ($0.7 billion); and GEP ($4.2 billion). |
• | an increase in chargebacks primarily due to products that have lost exclusivity in the U.S. and increasing competitive pressures, as well as increases for certain U.S. branded products; and |
• | an increase in Medicaid and related state program rebates, primarily as a result of updated estimates of sales related to these programs, as well as a decrease in Managed Medicaid estimated rebates in the second quarter of 2014. |
The following table provides revenue information for several of our major biopharmaceutical products: | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | % Change(b) | June 28, 2015 | % Change(b) | |||||||||||||
PRODUCT | PRIMARY INDICATIONS | Business(a) | |||||||||||||||
Prevnar family(c) | Vaccines for prevention of pneumococcal disease | V | $ | 1,503 | 37 | $ | 2,808 | 39 | |||||||||
Lyrica(d) | Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury | GEP/GIP | 1,219 | (7 | ) | 2,406 | (2 | ) | |||||||||
Enbrel (Outside the U.S. and Canada) | Rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis | GIP | 822 | (16 | ) | 1,581 | (16 | ) | |||||||||
Lipitor | Reduction of LDL cholesterol | GEP | 509 | (6 | ) | 950 | (5 | ) | |||||||||
Viagra(e) | Erectile dysfunction | GEP/GIP | 448 | 5 | 843 | 5 | |||||||||||
Sutent | Advanced and/or metastatic renal cell carcinoma (mRCC), refractory gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumor | O | 294 | (5 | ) | 536 | (7 | ) | |||||||||
Zyvox | Bacterial infections | GEP | 259 | (26 | ) | 530 | (21 | ) | |||||||||
Norvasc | Hypertension | GEP | 251 | (11 | ) | 503 | (10 | ) | |||||||||
Premarin family | Symptoms of menopause | GEP | 259 | (5 | ) | 491 | (6 | ) | |||||||||
Celebrex | Arthritis pain and inflammation, acute pain | GEP | 224 | (71 | ) | 428 | (69 | ) | |||||||||
BeneFIX | Hemophilia | GIP | 193 | (15 | ) | 366 | (14 | ) | |||||||||
Vfend | Fungal infections | GEP | 162 | (27 | ) | 345 | (13 | ) | |||||||||
Pristiq | Depression | GEP | 177 | (11 | ) | 338 | (9 | ) | |||||||||
Chantix/Champix | An aid to smoking cessation treatment | GIP | 173 | 2 | 332 | 5 | |||||||||||
Genotropin | Replacement of human growth hormone | GIP | 167 | (14 | ) | 306 | (15 | ) | |||||||||
Refacto AF/Xyntha | Hemophilia | GIP | 142 | (17 | ) | 262 | (17 | ) | |||||||||
Xalkori | Anaplastic lymphoma kinase positive non-small cell lung cancer | O | 119 | 10 | 230 | 17 | |||||||||||
Xeljanz | Rheumatoid arthritis | GIP | 128 | 87 | 224 | 86 | |||||||||||
Medrol | Inflammation | GEP | 113 | (1 | ) | 215 | (3 | ) | |||||||||
Inlyta | Advanced renal cell carcinoma (RCC) | O | 111 | 10 | 206 | 9 | |||||||||||
Xalatan/Xalacom | Glaucoma and ocular hypertension | GEP | 99 | (23 | ) | 201 | (19 | ) | |||||||||
Zoloft | Depression and certain anxiety disorders | GEP | 93 | (11 | ) | 179 | (13 | ) | |||||||||
Sulperazon | Antibiotic | GEP | 80 | (12 | ) | 179 | (1 | ) | |||||||||
Ibrance | Advanced breast cancer | O | 140 | * | 178 | * | |||||||||||
Relpax | Treats the symptoms of migraine headache | GEP | 82 | (16 | ) | 162 | (12 | ) | |||||||||
Fragmin | Anticoagulant | GEP | 88 | (7 | ) | 162 | (8 | ) | |||||||||
EpiPen | Epinephrine injection used in treatment of life-threatening allergic reactions | GEP | 85 | (5 | ) | 161 | 6 | ||||||||||
Zithromax/Zmax | Bacterial infections | GEP | 68 | (10 | ) | 154 | (8 | ) | |||||||||
Tygacil | Antibiotic | GEP | 77 | (7 | ) | 150 | (4 | ) | |||||||||
Effexor | Depression and certain anxiety disorders | GEP | 74 | (23 | ) | 147 | (17 | ) | |||||||||
Toviaz | Overactive bladder | GIP | 71 | (10 | ) | 134 | (5 | ) | |||||||||
Revatio | Pulmonary arterial hypertension (PAH) | GEP | 65 | (5 | ) | 128 | (12 | ) | |||||||||
BMP2 | Development of bone and cartilage | GIP | 75 | 47 | 113 | 24 | |||||||||||
Xanax/Xanax XR | Anxiety disorders | GEP | 54 | (19 | ) | 109 | (14 | ) | |||||||||
Cardura | Hypertension/Benign prostatic hyperplasia | GEP | 55 | (20 | ) | 106 | (21 | ) | |||||||||
Rapamune | Prevention of organ rejection in kidney transplantation | GIP | 53 | (39 | ) | 106 | (39 | ) | |||||||||
Unasyn | Injectable antibacterial | GEP | 50 | (6 | ) | 105 | 6 | ||||||||||
Somavert | Acromegaly | GIP | 55 | (6 | ) | 104 | (4 | ) | |||||||||
Neurontin | Seizures | GEP | 48 | (18 | ) | 103 | (4 | ) | |||||||||
Depo-Provera | Contraceptive | GEP | 51 | 27 | 88 | (5 | ) | ||||||||||
FSME-IMMUN/TicoVac | Tick-borne encephalitis vaccine | V | 56 | * | 65 | * | |||||||||||
Alliance revenues(f) | Various | GEP/GIP | 311 | 32 | 533 | 19 | |||||||||||
All other biopharmaceutical(g) | Various | GIP/GEP/V/O | 1,780 | (15 | ) | 3,558 | (13 | ) | |||||||||
All other GIP(g) | GIP | 87 | (34 | ) | 178 | (25 | ) | ||||||||||
All other GEP(g) | GEP | 1,623 | (15 | ) | 3,256 | (13 | ) | ||||||||||
All other V/O(g) | V/O | 70 | 37 | 124 | 34 |
(a) | Indicates the business to which the revenues relate. GIP = the Global Innovative Pharmaceutical segment; V = the Global Vaccines business; O = the Global Oncology business; and GEP = the Global Established Pharmaceutical segment. |
(b) | As compared to the three and six months ended June 29, 2014, as applicable. |
(c) | In the second quarter and the first six months of 2015, all revenues were composed of Prevnar 13/Prevenar 13. In the second quarter and first six months of 2014, revenues were composed of the Prevnar family of products, which included Prevnar 13/Prevenar 13 and, to a much lesser extent, Prevenar (7-valent). |
(d) | Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in GEP. All other Lyrica revenues are included in GIP. |
(e) | Viagra revenues from the U.S. and Canada are included in GIP. All other Viagra revenues are included in GEP. |
(f) | Includes Eliquis (GIP), Rebif (GIP), Spiriva (GEP) and Aricept (GEP). |
(g) | All other GIP, All other GEP and All other V/O are subsets of All other biopharmaceutical revenues. |
• | Prevnar/Prevenar 13 (V), is our pneumococcal conjugate vaccine for the prevention of pneumococcal disease. Overall, worldwide revenues for Prevnar/Prevenar 13 increased 43% operationally in the second quarter of 2015, and 45% operationally in the first six months of 2015, compared to the same periods in 2014. Foreign exchange had an unfavorable impact on worldwide revenues of 6% in the second quarter and the first six months of 2015, compared to the same periods in 2014. |
• | Lyrica (GEP (revenues from all of Europe, Russia, Turkey, Israel and Central Asia)/GIP (All other revenues)) is indicated in the U.S. for three neuropathic pain conditions, fibromyalgia and adjunctive therapy for adult patients with partial onset seizures. In certain markets outside the U.S., indications include neuropathic pain (peripheral and central), fibromyalgia, adjunctive treatment of epilepsy and generalized anxiety disorder. Worldwide revenues for Lyrica increased 1% operationally in the second quarter of 2015, and 5% operationally in the first six months of 2015, compared to the same periods in 2014. Foreign exchange had an unfavorable impact on worldwide revenues of 8% in the second quarter of 2015, and 7% in the first six months of 2015, compared to the same periods in 2014. |
• | Enbrel (GIP, outside the U.S. and Canada), indicated for the treatment of moderate-to-severe rheumatoid arthritis, polyarticular juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis (a type of arthritis affecting the spine), and nonradiographic axial spondyloarthritis, recorded an increase in worldwide revenues, excluding the U.S. and Canada, of 2% operationally in the second quarter of 2015, and a decrease of 2% operationally in the first six months of 2015, compared to the same periods in 2014. Results for the second quarter of 2015 were favorably impacted by demand in certain markets in Europe and Asia, partially offset by the timing of government purchases in Latin America and to a lesser extent, the change in the distribution channel in the U.K. Results for the first six months of 2015 were unfavorably impacted by a change in the distribution channel in the U.K. Foreign exchange had an unfavorable impact of 18% in the second quarter of 2015, and 14% in the first six months of 2015, compared to the same periods in 2014. |
• | Lipitor (GEP) is indicated for the treatment of elevated LDL-cholesterol levels in the blood. Lipitor faces generic competition in all major developed markets. Branded Lipitor recorded worldwide revenues of $509 million, or a decrease of 1% operationally in the second quarter of 2015, and $950 million, or an increase of 1% operationally in the first six months of 2015, compared to the same periods in 2014. Results for the second quarter of 2015 were unfavorably impacted by continued brand erosion due to generic competition in developed markets. Results for the first six months of 2015 increased primarily due to strong volume growth in emerging markets, primarily in China, resulting from reallocation of field force and promotional efforts, partially offset by brand erosion due to generic competition and increased payer pressure worldwide. Foreign exchange had an unfavorable impact of 5% in the second quarter of 2015, and 6% in the first six months of 2015, compared to the same periods in 2014. |
• | Viagra (GIP (U.S. and Canada revenues)/GEP (All other revenues excluding U.S. and Canada)) is indicated for the treatment for erectile dysfunction. Viagra worldwide revenues increased 8% operationally in the second quarter of 2015, and 9% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to strong operational performance in the U.S. and emerging markets. International revenues decreased 5% operationally in the second quarter of 2015, and 3% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to the impact of generic competition in developed markets outside of North America, partially offset by strong operational performance in China. Foreign exchange had an unfavorable impact on international revenues of 8% in the second quarter of 2015, and 10% in the first six months of 2015, compared to the same periods in 2014. Revenues in the U.S. increased 14% in the second quarter of 2015, and 15% in the first six months of 2015, compared to the same periods in 2014, primarily driven by price increases, higher purchases from the U.S. Department of Veterans Affairs/Department of Defense, and increased quantity per prescription, partially offset by lower commercial demand resulting from price sensitivity. |
• | Sutent (O) is indicated for the treatment of advanced renal cell carcinoma, including metastatic renal cell carcinoma (mRCC); gastrointestinal stromal tumors after disease progression on, or intolerance to, imatinib mesylate; and advanced pancreatic neuroendocrine tumor. Sutent worldwide revenues increased 7% operationally in the second quarter of 2015, and increased 4% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to price increases in the U.S., as well as strong demand in certain European and emerging markets. Foreign exchange had an unfavorable impact of 12% in the second quarter of 2015, and 11% in the first six months of 2015, compared to the same periods in 2014. |
• | Zyvox (GEP) is among the world’s best-selling branded agents used to treat serious Gram-positive pathogens, including methicillin-resistant staphylococcus-aureus. Zyvox worldwide revenues decreased 17% operationally in the second quarter of 2015, and 13% operationally in the first six months of 2015, compared to the same periods in 2014, due to generic competition in the U.S. beginning in the first half of 2015, partially offset by growth in China. Foreign exchange had an unfavorable impact of 9% in the second quarter of 2015, and 8% in the first six months of 2015, compared to the same periods in 2014. |
• | Norvasc (GEP) is indicated for the treatment of hypertension. Norvasc worldwide revenues decreased 4% operationally in the second quarter of 2015, and 3% operationally in the first six months of 2015, compared to the same periods in 2014, due to generic erosion, primarily in Japan, partially offset by volume growth in emerging markets, primarily in China. Foreign exchange had an unfavorable impact of 7% in the second quarter and in the first six months of 2015, compared to the same periods in 2014. |
• | Our Premarin family of products (GEP) helps women address moderate-to-severe menopausal symptoms. Premarin worldwide revenues decreased 4% operationally in the second quarter of 2015, and 5% operationally in the first six months of 2015, compared to the same periods in 2014. Revenues in the U.S. were unfavorably impacted by prescription volume declines for Premarin Family Oral brands, partially offset by price increases. |
• | Celebrex (GEP), indicated for the treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis worldwide and for the management of acute pain in adults in the U.S., Japan and certain other markets, recorded a decrease in worldwide revenues of 68% operationally in the second quarter of 2015, and 66% operationally in the first six months of 2015, compared to the same periods in 2014, primarily driven by the loss of exclusivity and launch of multi-source generic competition in the U.S. (December 2014) and in most other developed markets. Foreign exchange had an unfavorable impact of 3% in the second quarter and the first six months of 2015, compared to the same periods in 2014. |
• | BeneFIX and ReFacto AF/Xyntha (GIP) are hemophilia products using state-of-the-art manufacturing that assist patients with their lifelong hemophilia bleeding disorders. BeneFIX worldwide revenues decreased 7% operationally in the second quarter and in the first six months of 2015, compared to the same periods in 2014, primarily as a result of the erosion of market share in the U.S. due to the launch of competing new extended half-life treatment options. Foreign exchange had an unfavorable impact on revenues of 8% in the second quarter of 2015, and 7% in the first six months of 2015, compared to the same periods in 2014. |
• | Pristiq (GEP) is indicated for the treatment of major depressive disorder in the U.S. and in various other countries. Pristiq has also been indicated for treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause in Thailand, Mexico, the Philippines and Ecuador. Pristiq recorded a decrease in worldwide revenues of 7% operationally in the second quarter of 2015, and 5% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to decreased market share in the U.S., partially offset by U.S. market price increases. Foreign exchange had an unfavorable impact on revenues of 4% in the second quarter and the first six months of 2015, compared to the same periods in 2014. |
• | Chantix/Champix (GIP) is an aid to smoking-cessation treatment in adults 18 years of age and older. Worldwide revenues increased 8% operationally in the second quarter of 2015, and 10% operationally in the first six months of 2015, compared to the same periods in 2014. Foreign exchange had an unfavorable impact on revenues of 6% in the second quarter of 2015, and 5% in the first six months of 2015, compared to the same periods in 2014. |
• | Xalkori (O) is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. Xalkori worldwide revenues increased 19% operationally in the second quarter of 2015, and 26% operationally in the first six months of 2015, compared to the same periods in 2014, as a result of an increase in diagnostic rates for the ALK gene mutation, which has led to more patients being treated, and price increases in the U.S. Foreign exchange had a 9% unfavorable impact in the second quarter and the first six months of 2015, compared to the same periods in 2014. |
• | Xeljanz (GIP) is approved for use as a second-line therapy for the treatment of adult patients with moderate to severe active rheumatoid arthritis (after traditional disease-modifying antirheumatic drugs) in more than 40 markets including the U.S., Japan, Australia, Canada, Switzerland and Brazil. Xeljanz recorded an increase in worldwide revenues of 89% operationally in the second quarter of 2015, and 88% operationally in the first six months of 2015, compared to the same periods in 2014, primarily in the U.S., driven by continued growth through rheumatologist acceptance and consumer awareness. Foreign exchange had a 2% unfavorable impact in the second quarter and in the first six months of 2015, compared to the same periods in 2014. |
• | Inlyta (O) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of a prior systemic treatment. Worldwide revenues increased 21% operationally in the second quarter of 2015, and 19% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to increased market share. Revenues in the U.S. increased 21% in the second quarter of 2015, and 16% in the first six months of 2015, compared to the same periods in 2014, primarily due to increased market share and price increases. International revenues increased 21% operationally in the second quarter of 2015, and 22% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to strong growth in developed markets in Europe, where a large proportion of oncologists are prescribing Inlyta. Foreign exchange had an unfavorable impact on international revenues of 19% in the second quarter of 2015, and 18% in the first six months of 2015, compared to the same periods in 2014. |
• | Ibrance (O), indicated as a first-line treatment for certain forms of advanced breast cancer, was approved and launched in the U.S. in February 2015. Ibrance recorded worldwide revenues of $140 million in the second quarter of 2015 and $178 million in the first six months of 2015. |
• | Alliance revenues (GEP/GIP) increased 41% operationally worldwide in the second quarter of 2015, and 26% operationally in the first six months of 2015, compared to the same periods in 2014, mainly due to: |
◦ | an increase in Eliquis alliance revenues, |
◦ | the termination of the co-promotion collaboration for Spiriva (GEP) in most developed markets, which resulted in a decrease in Pfizer’s share of Spiriva revenues of approximately $30 million operationally in the second quarter of 2015, and $100 million operationally in the first six months of 2015, compared to the same periods in 2014. |
• | Eliquis (apixaban) (GIP) is being jointly developed and commercialized by Pfizer and Bristol-Myers Squibb (BMS). The two companies share commercialization expenses and profit/losses equally on a global basis. In April 2015, we signed an agreement with BMS to transfer full commercialization rights in certain smaller markets to us, beginning in the third quarter of 2015. BMS will supply the product to us at cost plus a percentage of the net sales to end-customers in these markets. Eliquis is part of the Novel Oral Anticoagulant (NOAC) market; the agents in this class were developed as alternative treatment options to warfarin in appropriate patients. Eliquis (apixaban) is approved for multiple indications in major markets around the world: |
◦ | to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); |
◦ | for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy; and |
◦ | for the prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery. |
RECENT FDA APPROVALS | ||
PRODUCT | INDICATION | DATE APPROVED |
Ibrance (Palbociclib) | An oral and selective reversible inhibitor of the CDK 4 and 6 kinases in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease | February 2015 |
Trumenba (MnB rLP2086) | A prophylactic vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age | October 2014 |
Eliquis (Apixaban)(a) | Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial treatment | August 2014 |
(a) | This indication for Eliquis (apixaban) was developed and is being commercialized in collaboration with BMS. |
PENDING U.S. NEW DRUG APPLICATIONS (NDA) AND SUPPLEMENTAL FILINGS | ||
PRODUCT | PROPOSED INDICATION | DATE FILED* |
Tofacitinib | QD MR (once-a-day) dosing | July 2015 |
ALO-02 (oxycodone HCI/ naltrexone/HCI) | A Mu-type opioid receptor agonist for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate | February 2015 |
Xeljanz (Tofacitinib) | Treatment of adult patients with moderate to severe chronic plaque psoriasis | February 2015 |
Tafamidis meglumine(a) | Treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) | February 2012 |
Celebrex (Celecoxib)(b) | Chronic pain | October 2009 |
Viviant (Bazedoxifene)(c) | Osteoporosis treatment and prevention | August 2006 |
* | The dates set forth in this column are the dates on which the FDA accepted our submissions. |
(a) | In May 2012, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted that the tafamidis meglumine data provide substantial evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. In June 2012, the FDA issued a “complete response” letter with respect to the tafamidis NDA. The FDA has requested the completion of a second efficacy study, and also has asked for additional information on the data within the current tafamidis NDA. We continue to work with the FDA to define a path forward. |
(b) | In June 2010, we received a “complete response” letter from the FDA for the Celebrex chronic pain supplemental NDA. The supplemental NDA remains pending. There are no additional granted patents related to this potential approval. |
(c) | NDAs for Viviant (bazedoxifene) for treatment and prevention of post-menopausal osteoporosis remain pending before the FDA. In February 2008, the FDA advised it expected to convene an advisory committee pending responses to the “approvable letters” received in December 2007 and May 2008 with respect to the NDAs. In view of the approval of Duavee (conjugated estrogens/bazedoxifene), we continue to assess next steps for Viviant. |
REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN | |||
PRODUCT | DESCRIPTION OF EVENT | DATE APPROVED | DATE FILED* |
Xeljanz (Tofacitinib) | Application filed in Japan for treatment of psoriasis vulgaris and psoriatic arthritis with inadequate response to existing therapies | — | March 2015 |
Eliquis (Apixaban)(a) | Application filed in Japan for treatment of venous thromboembolism | — | February 2015 |
Xalkori (Crizotinib) | Application filed in the EU for first line treatment of ALK-positive non-small cell lung cancer | — | January 2015 |
Duavive (Conjugated Estrogens/Bazedoxifene) | Approval in the EU for treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate | December 2014 | — |
Effexor SR (Venlafaxine HCl) | Application filed in Japan for treatment of depression/depressed state | — | December 2014 |
Bosulif (Bosutinib) | Approval in Japan for treatment of previously treated chronic myelogenous leukemia | September 2014 | — |
* | For applications in the EU, the dates set forth in this column are the dates on which the European Medicines Agency (EMA) validated our submissions. |
(a) | This indication for Eliquis (apixaban) was developed and is being commercialized in collaboration with BMS. |
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS FOR IN-LINE AND IN-REGISTRATION PRODUCTS | |
PRODUCT | PROPOSED INDICATION |
Bosulif (Bosutinib) | First-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia, which is being developed in collaboration with Avillion Group |
Inlyta (Axitinib) | Adjuvant treatment of renal cell carcinoma, which is being developed in collaboration with SFJ Pharmaceuticals Group |
Ibrance (Palbociclib) | An oral and selective reversible inhibitor of the CDK 4 and 6 kinases for the first-line treatment of patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ex-U.S.), as well as for the treatment of recurrent advanced breast cancer and, in collaboration with the German Breast Group, high-risk early breast cancer |
Lyrica (Pregabalin) | Peripheral neuropathic pain; CR (once-a-day) dosing |
Sutent (Sunitinib) | Adjuvant treatment of renal cell carcinoma |
Tofacitinib | Treatment of psoriasis (ex-US), ulcerative colitis, and psoriatic arthritis |
Vyndaqel (Tafamidis meglumine) | Adult symptomatic transthyretin cardiomyopathy |
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT | |
CANDIDATE | PROPOSED INDICATION |
Avelumab (PF-06834635) (MSB0010718C) | A monoclonal antibody that inhibits PD-L1 for the treatment of stage IIIb/IV non-small cell lung cancer that has progressed after a platinum-containing doublet, which is being developed in collaboration with Merck KGaA, Germany |
Bococizumab | A monoclonal antibody that inhibits PCSK9 for the treatment of hyperlipidemia and prevention of cardiovascular events |
Dacomitinib | A pan-HER tyrosine kinase inhibitor for the first-line treatment of patients with advanced non-small cell lung cancer with EGFR activating mutations, which is being developed in collaboration with SFJ Pharmaceuticals Group |
Ertugliflozin | An oral SGLT2 inhibitor for the treatment of type 2 diabetes, which is being developed in collaboration with Merck & Co., Inc. |
Inotuzumab ozogamicin | An antibody drug conjugate, consisting of an anti-CD22 monotherapy antibody linked to a cytotoxic agent, calicheamycin, for the treatment of acute lymphoblastic leukemia |
PF-06836922 | A long-acting hGH-CTP for the treatment of growth hormone deficiency (GHD) in adults, which is being developed in collaboration with OPKO Health, Inc. |
PF-06438179(a) | A potential biosimilar to Remicade® (infliximab) |
PF-05280014(b) | A potential biosimilar to Herceptin® (trastuzumab) |
PF-05280586(c) | A potential biosimilar to Rituxan® (rituximab) |
PF-06439535(d) | A potential biosimilar to Avastin® (bevacizumab) |
PF-06410293(e) | A potential biosimilar to Humira® (adalimumab) |
Rivipansel (GMI-1070) | A pan-selectin inhibitor for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease, which was licensed from GlycoMimetics Inc. |
Tanezumab(f) | An anti-nerve growth factor monoclonal antibody for the treatment of pain |
Trumenba | A prophylactic vaccine for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age (ex-U.S.) |
(a) | Remicade® is a registered trademark of Janssen Biotech, Inc. |
(b) | Herceptin® is a registered trademark of Genentech, Inc. |
(c) | Rituxan® is a registered trademark of Biogen MA Inc. |
(d) | Avastin® is a registered trademark of Genentech, Inc. |
(e) | Humira® is a registered trademark of AbbVie Biotechnology Ltd. |
(f) | In March 2015, we and our alliance partner, Eli Lilly & Company, announced that we are preparing to resume the Phase 3 clinical program for tanezumab. This announcement followed a decision by the FDA to lift the partial clinical hold on the tanezumab development program after a review of nonclinical data characterizing the sympathetic nervous system response to tanezumab. A partial clinical hold had been in place for tanezumab since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. |
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Cost of sales | $ | 2,180 | $ | 2,462 | (11 | ) | $ | 4,018 | $ | 4,507 | (11 | ) | ||||||||||
As a percentage of Revenues | 18.4 | % | 19.3 | % | 17.7 | % | 18.7 | % |
• | favorable foreign exchange of 10%; and |
• | to a lesser extent, a decrease in royalty expense, |
• | an increase in sales volumes, including as a result of the acquisition of Baxter’s portfolio of marketed vaccines in Europe. |
• | favorable foreign exchange; and |
• | to a lesser extent, a decrease in royalty expenses. |
• | favorable foreign exchange of 12%, |
• | an increase in sales volumes, including as a result of the acquisition of Baxter’s portfolio of marketed vaccines in Europe. |
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Selling, informational and administrative expenses | $ | 3,386 | $ | 3,520 | (4 | ) | $ | 6,491 | $ | 6,560 | (1 | ) | ||||||||||
As a percentage of Revenues | 28.6 | % | 27.6 | % | 28.6 | % | 27.2 | % |
• | the favorable impact of foreign exchange of 7% for the second quarter of 2015 and 6% for the first six months of 2015; and |
• | lower field force, advertising and promotional expenses, reflecting the benefits of cost-reduction and productivity initiatives, |
• | promotional expenses for Prevnar 13 in adults in the U.S., as well as increased costs to support several recently launched products and other in-line products; |
• | an increase in compensation costs in the U.S.; and |
• | a higher cost in the first six months of 2015 for the Branded Prescription Drug Fee compared to the same period in 2014. |
Three Months Ended | Six Months Ended | ||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | |||||||||||||||
Research and development expenses | $ | 1,734 | $ | 1,759 | (1 | ) | $ | 3,620 | $ | 3,382 | 7 | ||||||||||
As a percentage of Revenues | 14.6 | % | 13.8 | % | 15.9 | % | 14.0 | % |
• | the favorable impact of foreign exchange of 2%; and |
• | lower clinical trial expenses for Trumenba, Prevnar 13 adult, and certain oncology products, as well as lower clinical trial expenses as a result of completion of postmarketing commitments, primarily for certain in-line products, |
• | incremental investment in the late-stage pipeline, primarily bococizumab; and |
• | increased investment in biosimilar and generic sterile injectable development programs. |
• | the $295 million upfront payment to OPKO in the first quarter of 2015 associated with a worldwide development and commercialization agreement; |
• | investment in the late-stage pipeline, primarily bococizumab; and |
• | increased investment in biosimilar and generic sterile injectable development programs, |
• | lower clinical trial expenses for Trumenba, Prevnar 13 adult and certain oncology products, as well as lower clinical trial expenses as a result of the completion of postmarketing commitments for certain in-line products; and |
• | the favorable impact of foreign exchange of 2%. |
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Amortization of intangible assets | $ | 872 | $ | 1,001 | (13 | ) | $ | 1,811 | $ | 2,118 | (14 | ) | ||||||||||
As a percentage of Revenues | 7.4 | % | 7.8 | % | 8.0 | % | 8.8 | % |
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Restructuring charges and certain acquisition-related costs | $ | 86 | $ | 81 | 6 | $ | 146 | $ | 139 | 5 | ||||||||||||
Total additional depreciation—asset restructuring | 28 | 102 | (72 | ) | 47 | 176 | (73 | ) | ||||||||||||||
Total implementation costs | 45 | 76 | (41 | ) | 93 | 108 | (14 | ) | ||||||||||||||
Costs associated with acquisitions and cost-reduction/productivity initiatives(a) | $ | 159 | $ | 259 | (39 | ) | $ | 286 | $ | 423 | (32 | ) |
(a) | Comprises Restructuring charges and certain acquisition-related costs as well as costs associated with our cost-reduction/productivity initiatives included in Cost of sales, Research and development expenses and/or Selling, informational and administrative expenses, as appropriate. |
Three Months Ended | Six Months Ended | |||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||
Other (income)/deductions––net | $ | 55 | $ | (53 | ) | * | $ | 9 | $ | 570 | (98) |
Three Months Ended | Six Months Ended | |||||||||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | June 28, 2015 | June 29, 2014 | % Change | ||||||||||||||||
Provision for taxes on income | $ | 905 | $ | 1,082 | (16 | ) | $ | 1,610 | $ | 1,664 | (3 | ) | ||||||||||
Effective tax rate on continuing operations | 25.6 | % | 27.0 | % | 24.3 | % | 24.3 | % |
• | senior management receives a monthly analysis of our operating results that is prepared on an Adjusted income basis; |
• | our annual budgets are prepared on an Adjusted income basis; and |
• | senior management’s annual compensation is derived, in part, using this Adjusted income measure. See the “Adjusted Income––General Description of Adjusted Income Measure” section of our 2014 Financial Report for additional information. |
Three Months Ended June 28, 2015 | ||||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA | GAAP Reported | Purchase Accounting Adjustments(a) | Acquisition-Related Costs(a) | Discontinued Operations(a) | Certain Significant Items(a) | Non-GAAP Adjusted | ||||||||||||||||||
Revenues | $ | 11,853 | $ | — | $ | — | $ | — | $ | — | $ | 11,853 | ||||||||||||
Cost of sales | 2,180 | (1 | ) | (17 | ) | — | (39 | ) | 2,123 | |||||||||||||||
Selling, informational and administrative expenses | 3,386 | 1 | — | — | (15 | ) | 3,372 | |||||||||||||||||
Research and development expenses | 1,734 | 2 | — | — | (4 | ) | 1,732 | |||||||||||||||||
Amortization of intangible assets | 872 | (839 | ) | — | — | — | 33 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 86 | — | (51 | ) | — | (35 | ) | — | ||||||||||||||||
Other (income)/deductions––net | 55 | 3 | — | — | (211 | ) | (153 | ) | ||||||||||||||||
Income from continuing operations before provision for taxes on income | 3,539 | 835 | 68 | — | 305 | 4,747 | ||||||||||||||||||
Provision for taxes on income(b) | 905 | 238 | 18 | — | 52 | 1,213 | ||||||||||||||||||
Income from continuing operations | 2,635 | 597 | 50 | — | 252 | 3,534 | ||||||||||||||||||
Discontinued operations––net of tax | 1 | — | — | (1 | ) | — | — | |||||||||||||||||
Net income attributable to noncontrolling interests | 9 | — | — | — | — | 9 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 2,626 | 597 | 50 | (1 | ) | 252 | 3,525 | |||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.42 | 0.10 | 0.01 | — | 0.04 | 0.56 |
Six Months Ended June 28, 2015 | ||||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA | GAAP Reported | Purchase Accounting Adjustments(a) | Acquisition-Related Costs(a) | Discontinued Operations(a) | Certain Significant Items(a) | Non-GAAP Adjusted | ||||||||||||||||||
Revenues | $ | 22,717 | $ | — | $ | — | $ | — | $ | — | $ | 22,717 | ||||||||||||
Cost of sales | 4,018 | (3 | ) | (26 | ) | — | (60 | ) | 3,930 | |||||||||||||||
Selling, informational and administrative expenses | 6,491 | 1 | — | — | (43 | ) | 6,449 | |||||||||||||||||
Research and development expenses | 3,620 | 3 | — | — | (14 | ) | 3,609 | |||||||||||||||||
Amortization of intangible assets | 1,811 | (1,745 | ) | — | — | — | 67 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 146 | — | (65 | ) | — | (81 | ) | — | ||||||||||||||||
Other (income)/deductions––net | 9 | 5 | — | — | (335 | ) | (320 | ) | ||||||||||||||||
Income from continuing operations before provision for taxes on income | 6,621 | 1,738 | 91 | — | 532 | 8,982 | ||||||||||||||||||
Provision for taxes on income(b) | 1,610 | 499 | 24 | — | 113 | 2,247 | ||||||||||||||||||
Income from continuing operations | 5,011 | 1,239 | 67 | — | 419 | 6,736 | ||||||||||||||||||
Discontinued operations––net of tax | 6 | — | — | (6 | ) | — | — | |||||||||||||||||
Net income attributable to noncontrolling interests | 14 | — | — | — | — | 14 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 5,002 | 1,239 | 67 | (6 | ) | 419 | 6,721 | |||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.80 | 0.20 | 0.01 | — | 0.07 | 1.07 |
Three Months Ended June 29, 2014 | ||||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA | GAAP Reported | Purchase Accounting Adjustments(a) | Acquisition-Related Costs(a) | Discontinued Operations(a) | Certain Significant Items(a) | Non-GAAP Adjusted | ||||||||||||||||||
Revenues | $ | 12,773 | $ | — | $ | — | $ | — | $ | (71 | ) | $ | 12,702 | |||||||||||
Cost of sales | 2,462 | 14 | (16 | ) | — | (140 | ) | 2,320 | ||||||||||||||||
Selling, informational and administrative expenses | 3,520 | 4 | — | — | (38 | ) | 3,486 | |||||||||||||||||
Research and development expenses | 1,759 | — | — | — | (45 | ) | 1,714 | |||||||||||||||||
Amortization of intangible assets | 1,001 | (961 | ) | — | — | — | 40 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 81 | — | (31 | ) | — | (50 | ) | — | ||||||||||||||||
Other (income)/deductions––net | (53 | ) | (6 | ) | — | — | (36 | ) | (95 | ) | ||||||||||||||
Income from continuing operations before provision for taxes on income | 4,003 | 949 | 47 | — | 238 | 5,237 | ||||||||||||||||||
Provision for taxes on income(b) | 1,082 | 254 | 49 | — | 74 | 1,459 | ||||||||||||||||||
Income from continuing operations | 2,921 | 695 | (2 | ) | — | 164 | 3,778 | |||||||||||||||||
Discontinued operations––net of tax | — | — | — | — | — | — | ||||||||||||||||||
Net income attributable to noncontrolling interests | 9 | — | — | — | — | 9 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 2,912 | 695 | (2 | ) | — | 164 | 3,769 | |||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.45 | 0.11 | — | — | 0.03 | 0.58 |
Six Months Ended June 29, 2014 | ||||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA | GAAP Reported | Purchase Accounting Adjustments(a) | Acquisition-Related Costs(a) | Discontinued Operations(a) | Certain Significant Items(a) | Non-GAAP Adjusted | ||||||||||||||||||
Revenues | $ | 24,126 | $ | — | $ | — | $ | — | $ | (128 | ) | $ | 23,998 | |||||||||||
Cost of sales | 4,507 | 83 | (22 | ) | — | (262 | ) | 4,306 | ||||||||||||||||
Selling, informational and administrative expenses | 6,560 | 4 | — | — | (58 | ) | 6,506 | |||||||||||||||||
Research and development expenses | 3,382 | — | — | — | (56 | ) | 3,326 | |||||||||||||||||
Amortization of intangible assets | 2,118 | (2,037 | ) | — | — | — | 81 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 139 | — | (55 | ) | — | (84 | ) | — | ||||||||||||||||
Other (income)/deductions––net | 570 | (7 | ) | — | — | (922 | ) | (359 | ) | |||||||||||||||
Income from continuing operations before provision for taxes on income | 6,850 | 1,957 | 77 | — | 1,254 | 10,138 | ||||||||||||||||||
Provision for taxes on income(b) | 1,664 | 542 | 58 | — | 422 | 2,686 | ||||||||||||||||||
Income from continuing operations | 5,186 | 1,415 | 19 | — | 832 | 7,452 | ||||||||||||||||||
Discontinued operations––net of tax | 73 | — | — | (73 | ) | — | — | |||||||||||||||||
Net income attributable to noncontrolling interests | 18 | — | — | — | — | 18 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 5,241 | 1,415 | 19 | (73 | ) | 832 | 7,434 | |||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.81 | 0.22 | — | (0.01 | ) | 0.13 | 1.15 |
(a) | For details of adjustments, see “Details of Income Statement Items Excluded from Adjusted Income” below. |
(b) | The effective tax rate on Non-GAAP Adjusted income was 25.6% in the second quarter of 2015, compared with 27.9% in the second quarter of 2014. This decline was primarily due to a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, partially offset by a decline in tax benefits associated with the resolution of certain tax positions pertaining to prior years, with various foreign tax authorities, and the expiration of certain statutes of limitations. The effective tax rate on Non-GAAP Adjusted income was 25.0% in the first six months of 2015, compared with 26.5% in the first six months of 2014. This decline was primarily due to a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, partially offset by a decline in tax benefits associated with the resolution of certain tax positions pertaining to prior years, primarily with various foreign tax authorities, and the expiration of certain statutes of limitations. |
Adjusted income, as shown above, excludes the following items: | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | June 28, 2015 | June 29, 2014 | ||||||||||||
Purchase accounting adjustments | ||||||||||||||||
Amortization, depreciation and other(a) | $ | 834 | $ | 963 | $ | 1,735 | $ | 2,040 | ||||||||
Cost of sales | 1 | (14 | ) | 3 | (83 | ) | ||||||||||
Total purchase accounting adjustments––pre-tax | 835 | 949 | 1,738 | 1,957 | ||||||||||||
Income taxes(b) | (238 | ) | (254 | ) | (499 | ) | (542 | ) | ||||||||
Total purchase accounting adjustments––net of tax | 597 | 695 | 1,239 | 1,415 | ||||||||||||
Acquisition-related costs | ||||||||||||||||
Restructuring charges(c) | 8 | 16 | 5 | 22 | ||||||||||||
Transaction costs(c) | 1 | — | 6 | — | ||||||||||||
Pre-integration/integration costs(c) | 42 | 15 | 54 | 33 | ||||||||||||
Additional depreciation––asset restructuring(d) | 17 | 16 | 26 | 22 | ||||||||||||
Total acquisition-related costs––pre-tax | 68 | 47 | 91 | 77 | ||||||||||||
Income taxes(e) | (18 | ) | (49 | ) | (24 | ) | (58 | ) | ||||||||
Total acquisition-related costs––net of tax | 50 | (2 | ) | 67 | 19 | |||||||||||
Discontinued operations | ||||||||||||||||
Total discontinued operations––net of tax, attributable to Pfizer Inc.(f) | (1 | ) | — | (6 | ) | (73 | ) | |||||||||
Certain significant items | ||||||||||||||||
Restructuring charges(g) | 35 | 50 | 81 | 84 | ||||||||||||
Implementation costs and additional depreciation––asset restructuring(h) | 56 | 162 | 114 | 262 | ||||||||||||
Certain legal matters, net(i) | 92 | 4 | 92 | 698 | ||||||||||||
Certain asset impairments(i) | — | — | — | 114 | ||||||||||||
Business and legal entity alignment costs(j) | 63 | 39 | 164 | 67 | ||||||||||||
Other(k) | 58 | (17 | ) | 81 | 29 | |||||||||||
Total certain significant items––pre-tax | 305 | 238 | 532 | 1,254 | ||||||||||||
Income taxes(l) | (52 | ) | (74 | ) | (113 | ) | (422 | ) | ||||||||
Total certain significant items––net of tax | 252 | 164 | 419 | 832 | ||||||||||||
Total purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items––net of tax, attributable to Pfizer Inc. | $ | 899 | $ | 857 | $ | 1,719 | $ | 2,193 |
(a) | Included primarily in Amortization of intangible assets. |
(b) | Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. |
(c) | Included in Restructuring charges and certain acquisition-related costs (see Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives). Restructuring charges include employee termination costs, asset impairments and other exit costs associated with business combinations. Transaction costs represent external costs directly related to acquired businesses and primarily include expenditures for banking, legal, accounting and other similar services. Pre-integration costs represent external, incremental costs directly related to our pending acquisition with Hospira. Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. |
(d) | Represents the impact of changes in estimated useful lives of assets involved in restructuring actions related to acquisitions. Included in Cost of sales for both the three months and six months ended June 28, 2015 and June 29, 2014. |
(e) | Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. In the three months and six months ended June 29, 2014, also includes the favorable impact of the remeasurement of certain deferred tax liabilities resulting from plant network restructuring activities. |
(f) | Included in Discontinued operations––net of tax. For the six months ended June 29, 2014, represents post-close adjustments. |
(g) | Amounts relate to our cost-reduction/productivity initiatives. Included in Restructuring charges and certain acquisition-related costs (see Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives). |
(h) | Amounts relate to our cost-reduction/productivity initiatives (see Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives). |
(i) | Included in Other (income)/deductions—net (see the “Other (Income)/Deductions—Net” section of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net). |
(j) | Included in Other (income)/deductions––net. Represents expenses for planning and implementing changes to align our operations and reporting for our business segments established in 2014. |
(k) | Includes, among other things, income associated with the transitional manufacturing and supply agreements with Zoetis that are primarily included in Revenues ($71 million) and Cost of sales ($60 million) for the three months ended June 29, 2014 and in Revenues ($128 million) and Cost of sales ($110 million) for the six months ended June 29, 2014. Virtually all other items are included in Other (income)/deductions––net for the three months and six months ended June 28, 2015 and June 29, 2014. |
(l) | Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. |
The following tables provide revenue and cost information by reportable operating segment and a reconciliation of that information to our condensed consolidated statements of income: | ||||||||||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | GIP(a) | VOC(a) | Total Innovative Products(b) | Established Products (GEP)(a) | Other(c) | Non-GAAP Adjusted(d) | Reconciling Items(e) | GAAP Reported | ||||||||||||||||||||||||
Second Quarter of 2015 | ||||||||||||||||||||||||||||||||
Revenues | $ | 3,497 | $ | 3,133 | $ | 6,630 | $ | 5,090 | $ | 133 | $ | 11,853 | $ | — | $ | 11,853 | ||||||||||||||||
Cost of sales | 385 | 552 | 937 | 942 | 243 | 2,123 | 58 | 2,180 | ||||||||||||||||||||||||
Selling, informational and administrative expenses | 920 | 699 | 1,619 | 840 | 913 | 3,372 | 15 | 3,386 | ||||||||||||||||||||||||
Research and development expenses | 442 | 204 | 646 | 151 | 935 | 1,732 | 2 | 1,734 | ||||||||||||||||||||||||
Amortization of intangible assets | 11 | 12 | 23 | 10 | — | 33 | 839 | 872 | ||||||||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | 86 | 86 | ||||||||||||||||||||||||
Other (income)/deductions––net | (274 | ) | (12 | ) | (286 | ) | (30 | ) | 163 | (153 | ) | 209 | 55 | |||||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 2,013 | $ | 1,678 | $ | 3,691 | $ | 3,177 | $ | (2,121 | ) | $ | 4,747 | $ | (1,208 | ) | $ | 3,539 |
(MILLIONS OF DOLLARS) | GIP(a) | VOC(a) | Total Innovative Products(b) | Established Products (GEP)(a) | Other(c) | Non-GAAP Adjusted(d) | Reconciling Items(e) | GAAP Reported | ||||||||||||||||||||||||
Six Months Ended June 28, 2015 | ||||||||||||||||||||||||||||||||
Revenues | $ | 6,572 | $ | 5,796 | $ | 12,368 | $ | 10,104 | $ | 244 | $ | 22,717 | $ | — | $ | 22,717 | ||||||||||||||||
Cost of sales | 727 | 976 | 1,703 | 1,859 | 367 | 3,930 | 89 | 4,018 | ||||||||||||||||||||||||
Selling, informational and administrative expenses | 1,728 | 1,294 | 3,021 | 1,544 | 1,884 | 6,449 | 42 | 6,491 | ||||||||||||||||||||||||
Research and development expenses | 1,064 | 398 | 1,462 | 285 | 1,862 | 3,609 | 10 | 3,620 | ||||||||||||||||||||||||
Amortization of intangible assets | 23 | 24 | 47 | 20 | — | 67 | 1,745 | 1,811 | ||||||||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | 146 | 146 | ||||||||||||||||||||||||
Other (income)/deductions––net | (494 | ) | (37 | ) | (531 | ) | (37 | ) | 249 | (320 | ) | 329 | 9 | |||||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 3,524 | $ | 3,143 | $ | 6,666 | $ | 6,433 | $ | (4,117 | ) | $ | 8,982 | $ | (2,361 | ) | $ | 6,621 |
(MILLIONS OF DOLLARS) | GIP(a) | VOC(a) | Total Innovative Products(b) | Established Products (GEP)(a) | Other(c) | Non-GAAP Adjusted(d) | Reconciling Items(e) | GAAP Reported | ||||||||||||||||||||||||
Second Quarter of 2014 | ||||||||||||||||||||||||||||||||
Revenues | $ | 3,547 | $ | 2,579 | $ | 6,126 | $ | 6,513 | $ | 63 | $ | 12,702 | $ | 71 | $ | 12,773 | ||||||||||||||||
Cost of sales | 475 | 519 | 994 | 1,169 | 157 | 2,320 | 142 | 2,462 | ||||||||||||||||||||||||
Selling, informational and administrative expenses | 929 | 656 | 1,585 | 1,028 | 873 | 3,486 | 34 | 3,520 | ||||||||||||||||||||||||
Research and development expenses | 372 | 251 | 623 | 151 | 940 | 1,714 | 45 | 1,759 | ||||||||||||||||||||||||
Amortization of intangible assets | 11 | 5 | 16 | 25 | (1 | ) | 40 | 961 | 1,001 | |||||||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | 81 | 81 | ||||||||||||||||||||||||
Other (income)/deductions––net | (249 | ) | (9 | ) | (258 | ) | (36 | ) | 199 | (95 | ) | 42 | (53 | ) | ||||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 2,009 | $ | 1,157 | $ | 3,166 | $ | 4,176 | $ | (2,105 | ) | $ | 5,237 | $ | (1,234 | ) | $ | 4,003 |
(MILLIONS OF DOLLARS) | GIP(a) | VOC(a) | Total Innovative Products(b) | Established Products (GEP)(a) | Other(c) | Non-GAAP Adjusted(d) | Reconciling Items(e) | GAAP Reported | ||||||||||||||||||||||||
Six Months Ended June 29, 2014 | ||||||||||||||||||||||||||||||||
Revenues | $ | 6,623 | $ | 4,753 | $ | 11,376 | $ | 12,503 | $ | 119 | $ | 23,998 | $ | 128 | $ | 24,126 | ||||||||||||||||
Cost of sales | 890 | 928 | 1,818 | 2,194 | 294 | 4,306 | 201 | 4,507 | ||||||||||||||||||||||||
Selling, informational and administrative expenses | 1,694 | 1,187 | 2,881 | 1,865 | 1,760 | 6,506 | 54 | 6,560 | ||||||||||||||||||||||||
Research and development expenses | 766 | 435 | 1,201 | 289 | 1,836 | 3,326 | 56 | 3,382 | ||||||||||||||||||||||||
Amortization of intangible assets | 22 | 9 | 31 | 50 | — | 81 | 2,037 | 2,118 | ||||||||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | 139 | 139 | ||||||||||||||||||||||||
Other (income)/deductions––net | (525 | ) | (20 | ) | (545 | ) | (120 | ) | 306 | (359 | ) | 929 | 570 | |||||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 3,776 | $ | 2,214 | $ | 5,990 | $ | 8,225 | $ | (4,077 | ) | $ | 10,138 | $ | (3,288 | ) | $ | 6,850 |
(a) | Amounts represent the revenues and costs managed by each of our operating segments. The expenses generally include only those costs directly attributable to the operating segment. |
(b) | Total Innovative Products represents the sum of the GIP and VOC segments. |
(c) | Other comprises the revenues and costs included in our Adjusted income components (see footnote (d) below) that are managed outside our three operating segments and includes the following: |
Quarter Ended June 28, 2015 | ||||||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | PCS(i) | WRD(ii), (vi) | Medical(iii), (vi) | Corporate(iv), (vi) | Other Unallocated(v), (vi) | Total | ||||||||||||||||||
Revenues | $ | 133 | $ | — | $ | — | $ | — | $ | — | $ | 133 | ||||||||||||
Cost of sales | 99 | — | — | 25 | 118 | 243 | ||||||||||||||||||
Selling, informational and administrative expenses | 3 | — | 28 | 871 | 11 | 913 | ||||||||||||||||||
Research and development expenses | 1 | 689 | 7 | 231 | 8 | 935 | ||||||||||||||||||
Amortization of intangible assets | — | — | — | — | — | — | ||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net | (1 | ) | (15 | ) | — | 159 | 19 | 163 | ||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 30 | $ | (674 | ) | $ | (35 | ) | $ | (1,286 | ) | $ | (156 | ) | $ | (2,121 | ) |
Six Months Ended June 28, 2015 | ||||||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | PCS(i) | WRD(ii), (vi) | Medical(iii), (vi) | Corporate(iv), (vi) | Other Unallocated(v), (vi) | Total | ||||||||||||||||||
Revenues | $ | 244 | $ | — | $ | — | $ | — | $ | — | $ | 244 | ||||||||||||
Cost of sales | 185 | — | — | 48 | 134 | 367 | ||||||||||||||||||
Selling, informational and administrative expenses | 6 | — | 54 | 1,807 | 17 | 1,884 | ||||||||||||||||||
Research and development expenses | 1 | 1,377 | 13 | 460 | 11 | 1,862 | ||||||||||||||||||
Amortization of intangible assets | — | — | — | — | — | — | ||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net | (1 | ) | (44 | ) | — | 257 | 36 | 249 | ||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 52 | $ | (1,333 | ) | $ | (66 | ) | $ | (2,573 | ) | $ | (197 | ) | $ | (4,117 | ) |
Quarter Ended June 29, 2014 | ||||||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | PCS(i) | WRD(ii), (vi) | Medical(iii), (vi) | Corporate(iv), (vi) | Other Unallocated(v), (vi) | Total | ||||||||||||||||||
Revenues | $ | 63 | $ | — | $ | — | $ | — | $ | — | $ | 63 | ||||||||||||
Cost of sales | 41 | — | — | 40 | 76 | 157 | ||||||||||||||||||
Selling, informational and administrative expenses | 4 | — | 29 | 832 | 8 | 873 | ||||||||||||||||||
Research and development expenses | — | 719 | 7 | 207 | 7 | 940 | ||||||||||||||||||
Amortization of intangible assets | (1 | ) | — | — | — | — | (1 | ) | ||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net | — | (23 | ) | — | 208 | 14 | 199 | |||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 19 | $ | (696 | ) | $ | (36 | ) | $ | (1,287 | ) | $ | (105 | ) | $ | (2,105 | ) |
Six Months Ended June 29, 2014 | ||||||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||||||
(MILLIONS OF DOLLARS) | PCS(i) | WRD(ii), (vi) | Medical(iii), (vi) | Corporate(iv), (vi) | Other Unallocated(v), (vi) | Total | ||||||||||||||||||
Revenues | $ | 119 | $ | — | $ | — | $ | — | $ | — | $ | 119 | ||||||||||||
Cost of sales | 77 | — | — | 51 | 166 | 294 | ||||||||||||||||||
Selling, informational and administrative expenses | 7 | — | 53 | 1,683 | 17 | 1,760 | ||||||||||||||||||
Research and development expenses | 1 | 1,382 | 13 | 427 | 13 | 1,836 | ||||||||||||||||||
Amortization of intangible assets | — | — | — | — | — | — | ||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net | — | (34 | ) | — | 326 | 14 | 306 | |||||||||||||||||
Income from continuing operations before provision for taxes on income | $ | 34 | $ | (1,348 | ) | $ | (66 | ) | $ | (2,487 | ) | $ | (210 | ) | $ | (4,077 | ) |
(i) | PCS—the revenues and costs of Pfizer CentreSource (PCS), our contract manufacturing and bulk pharmaceutical chemical sales operation. In the second quarter and first six months of 2015, PCS also includes revenues and expenses related to our transitional manufacturing and supply agreements with Zoetis. |
(ii) | WRD—the research and development expenses managed by our Worldwide Research and Development organization (WRD), which is generally responsible for research projects until proof-of-concept is achieved and then for transitioning those projects to the appropriate operating segment for possible clinical and commercial development. This organization also has responsibility for certain science-based and other platform-services organizations, which provide technical expertise and other services to the various R&D projects. WRD is also responsible for facilitating all regulatory submissions and interactions with regulatory agencies, including all safety-event activities. |
(iii) | Medical—the costs associated with our Pfizer Medical organization (Medical), which is responsible for the provision of medical information to healthcare providers, patients and other parties, transparency and disclosure activities, clinical trial results publication, grants for healthcare quality improvement and medical education, partnerships with global public health and medical associations, regulatory inspection readiness reviews, internal audits of Pfizer-sponsored clinical trials and internal regulatory compliance processes. |
(iv) | Corporate—the costs associated with Corporate, representing platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance, and worldwide procurement) and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. |
(v) | Other Unallocated—other unallocated costs, representing overhead expenses associated with our manufacturing and commercial operations not directly attributable to an operating segment. |
(vi) | See the “Analysis of Operating Segment Information” section of Pfizer’s 2014 Financial Report for certain qualitative information about our Other costs. This information will be provided on an annual basis. |
(d) | See the “Adjusted Income” section of this MD&A for a definition of these “Adjusted Income “ components. |
(e) | Includes costs associated with (i) purchase accounting adjustments; (ii) acquisition-related costs; and (iii) certain significant items, which are substantive, unusual items that are evaluated on an individual basis by management. For additional information about these reconciling items and/or our Non-GAAP Adjusted measure of performance, see the “Adjusted Income” section of this MD&A. |
• | Revenues decreased 1% in both the second quarter of 2015 and the first six months of 2015, compared to the same periods in 2014. Foreign exchange had an unfavorable impact of 9% on GIP revenues in the second quarter of 2015, and 8% on GIP revenues in the first six months of 2015, compared to the same periods in 2014. Revenues increased by 8% operationally in the second quarter of 2015 and increased by 7% operationally in the first six months of 2015, compared to the same periods in 2014, primarily due to: |
◦ | strong operational performance from recently launched products, including Eliquis globally and Xeljanz, primarily in the U.S. (collectively, up approximately $220 million for the second quarter of 2015 and $380 million for the first six months of 2015); and |
◦ | the continued strong performance of Lyrica, primarily in the U.S. and Japan, and Viagra in the U.S. (collectively, up approximately $130 million for the second quarter of 2015 and $300 million for the first six months of 2015), |
◦ | generic competition for Rapamune in the U.S., which began in October 2014, and by increased competition for BeneFIX in the U.S. (collectively, down approximately $40 million for the second quarter of 2015 and $90 million for the first six months of 2015). |
• | Cost of sales as a percentage of Revenues decreased 2.4 percentage points in the second quarter of 2015, compared to the same period in 2014, primarily driven by favorable foreign exchange, a decrease in royalty expense and an increase in alliance revenues, which have no associated cost of sales. Cost of sales as a percentage of Revenues decreased 2.3 percentage points in the first six months of 2015, compared to the same period in 2014, primarily driven by favorable foreign exchange, an increase in alliance revenue, which have no associated cost of sales, and a decrease in royalty expense. The decrease in Cost of sales of 19% in the second quarter of 2015, and 18% in the first six months of 2015, compared to the same periods in 2014, was primarily driven by favorable foreign exchange and, to a lesser extent, a decrease in royalty expense. |
• | The decrease in Selling, informational and administrative expenses of 1% in the second quarter of 2015, compared to the same period in 2014, reflects favorable foreign exchange, largely offset by additional investment in recently launched products and certain in-line products. The increase in Selling, informational and administrative expenses of 2% in the first six months of 2015, compared to the same period in 2014, reflects additional investment in recently launched products and certain in-line products, partially offset by favorable foreign exchange. |
• | The increase in Research and development expenses of 19% in the second quarter of 2015, compared to the same period in 2014, primarily reflects investment in the late-stage pipeline, primarily bococizumab, partially offset by lower clinical trial expenses as a result of the completion of postmarketing commitments for certain in-line products. The increase in Research and development expenses of 39% in the first six months of 2015, compared to the same period in 2014, primarily reflects the $295 million upfront payment to OPKO, and investment in the late-stage pipeline, primarily bococizumab, partially offset by lower clinical trial expenses as a result of the completion of postmarketing commitments for certain in-line products. |
• | Revenues increased 21% in the second quarter of 2015, and increased 22% in the first six months of 2015, compared to the same periods in 2014, which includes an increase in revenues of 29% operationally in both the second quarter of 2015 and in the first six months of 2015. |
◦ | Global Vaccines Revenues increased 44% to $1.6 billion in the second quarter of 2015, compared to $1.1 billion in the same period in 2014, and increased 44% to $2.9 billion in the first six months of 2015, compared to $2.0 billion in the same period in 2014, reflecting an operational increase in revenues of 52% in both the second quarter of 2015 and in the first six months of 2015. The increases were primarily due to an 87% increase in the second quarter of 2015 and 84% in the first six months of 2015 in Prevnar family revenue in the U.S., primarily driven by continued strong uptake among adults following the positive recommendation from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for use in adults aged 65 and older in the third quarter of 2014. International revenues increased 25% operationally in the second quarter of 2015 and 23% operationally in the first six months of 2015, driven by the Prevenar family, which grew 10% operationally in the second quarter of 2015 and 12% operationally in the first six months of 2015, primarily reflecting increased shipments associated with Gavi, the Vaccine Alliance, and the favorable impact of Prevenar’s inclusion in additional national immunization programs in certain emerging markets compared to the same periods in 2014, as well as the inclusion in the second quarter and first six months of 2015 of revenues associated with the acquisition of Baxter’s portfolio of marketed vaccines in Europe. |
◦ | Global Oncology Revenues increased 25% to $713 million in the second quarter of 2015, compared to $570 million in the same period in 2014, and increased 17% to $1.2 billion in the first six months of 2015, compared to $1.1 billion in the same period in 2014, reflecting an operational increase in revenues of 36% in the second quarter of 2015 and 27% in the first six months of 2015, primarily driven by our launch of Ibrance in the U.S. in February 2015 for advanced breast cancer, and, to a lesser extent, stronger demand for Sutent, Inlyta and Xalkori in most markets. |
◦ | Consumer Healthcare Revenues decreased 8% to $840 million in the second quarter of 2015, compared to $912 million in the same period in 2014, reflecting an operational decrease in revenues of 2% in the second quarter of 2015, as compared to the same period in 2014, primarily due to the non-recurrence of initial retailer stocking associated with the launch of Nexium 24HR in the U.S. in late-May 2014. Excluding Nexium 24HR, revenues in the Consumer Healthcare business in the U.S. increased 5% driven by increased promotional support for key brands. Additionally, revenues from emerging markets increased 11% operationally, primarily driven by China and Venezuela. Revenues decreased 1% to $1.6 billion in the first six months of 2015, compared to $1.7 billion in the same period in 2014, reflecting an operational increase in revenues of 4% in the first six months of 2015, primarily due to the launch of Nexium 24HR in the U.S. in late-May 2014, as well as growth in dietary supplement products in certain emerging markets primarily driven by China and Venezuela. |
• | Cost of sales as a percentage of Revenues decreased 2.5 percentage points in the second quarter of 2015 and decreased 2.7 percentage points in the first six months of 2015, compared to the same periods in 2014, primarily driven by favorable foreign exchange, manufacturing efficiencies and a favorable change in product mix. The increase in Cost of sales of 6% in the second quarter of 2015, and 5% in the first six months of 2015, compared to the same periods in 2014, was primarily due to an increase in sales volumes, including as a result of the acquisition of Baxter’s portfolio of marketed vaccines in Europe, largely offset by favorable foreign exchange and manufacturing efficiencies. |
• | Selling informational and administrative expenses increased 6% in the second quarter of 2015, compared to the same period in 2014, primarily driven by promotional expenses for Prevnar 13 in adults in the U.S., as well as the launch expenses for Ibrance (palbociclib) in the U.S., partially offset by favorable foreign exchange. The increase in Selling informational and administrative expenses of 9% in the first six months of 2015, compared to the same period in 2014, was primarily driven by promotional expenses for Prevnar 13 in adults in the U.S., as well as the launch expenses for Ibrance and Trumenba in the U.S., partially offset by favorable foreign exchange. |
• | Research and development expenses decreased 19% in the second quarter of 2015, and 9% in the first six months of 2015, compared to the same periods in 2014, primarily reflecting lower clinical trial spend for Trumenba, Prevnar 13 adult and certain oncology products, partially offset by increased costs associated with our vaccine and oncology programs, primarily our anti-PD-L1 alliance with Merck KGaA. |
• | Revenues decreased 22%, to $5.1 billion in the second quarter of 2015, compared to $6.5 billion in the same period in 2014, and decreased 19% to $10.1 billion in the first six months of 2015, compared to $12.5 billion in the same period in 2014, which includes an operational decrease in revenues of 14% in the second quarter of 2015 and 12% in the first six months of 2015, primarily due to: |
◦ | the loss of exclusivity and immediate launch of multi-source generic competition for Celebrex in the U.S. in December 2014 as well as generic competition for Zyvox in the U.S. beginning in the first half of 2015 and for Lyrica in certain developed Europe markets beginning in the first quarter of 2015 (collectively, down by approximately $630 million for the second quarter of 2015 and $1.1 billion for the first six months of 2015); |
◦ | a decline in Lipitor revenues in developed markets as a result of continued generic competition (down approximately $90 million for the second quarter of 2015 and $130 million for the first six months of 2015); and |
◦ | the termination in most countries of the co-promotion collaboration for Spiriva, including in the U.S. (where the collaboration expired in April 2014), which has resulted in a decline in Pfizer’s share of Spiriva revenues (down approximately $30 million for the second quarter of 2015 and $100 million for the first six months of 2015), |
◦ | growth in emerging markets, where revenues increased 2% operationally for the second quarter of 2015 and 6% for the first six months of 2015, primarily driven by Lipitor, Zyvox, Viagra and Norvasc (collectively, up by approximately $120 million for the second quarter of 2015 and $220 million for the first six months of 2015). |
• | Cost of sales as a percentage of Revenues increased 0.5 percentage points in the second quarter of 2015, compared to the same period in 2014, primarily due to the impact of losses of exclusivity resulting in an unfavorable change in product mix, partially offset by favorable foreign exchange. The decrease in Cost of sales of 19% in the second quarter of 2015, compared to the same period in 2014, was primarily driven by favorable foreign exchange, lower volumes due to products losing exclusivity, and, to a lesser extent, a decrease in royalty expense. Cost of sales as a percentage of Revenues increased 0.8 percentage points in the first six months of 2015, compared to the same period in 2014, primarily due to the impact of losses of exclusivity resulting in an unfavorable change in product mix, partially offset by favorable foreign exchange. The decrease in Cost of sales of 15% in the first six months of 2015, compared to the same period in 2014, was primarily driven by favorable foreign exchange and lower volumes as a result of products losing exclusivity. |
• | Selling, informational and administrative expenses decreased 18% in the second quarter of 2015, compared to the same period in 2014, primarily due to lower field force, advertising and promotional expenses, reflecting the benefits of cost-reduction and productivity initiatives, and the favorable impact of foreign exchange. The decrease in Selling, informational and administrative expenses of 17% in the first six months of 2015, compared to the same period in 2014, was primarily due to lower field force, advertising and promotional expenses, reflecting the benefits of cost reduction and productivity initiatives, and the favorable impact of foreign exchange, partially offset by a higher cost for the Branded Prescription Drug Fee compared to the prior year. |
• | Research and development expenses were largely unchanged in the second quarter of 2015 and in the first six months of 2015, compared to the same periods in 2014, reflecting increased investment in biosimilar and sterile injectable development programs, offset by lower clinical trial expenses related to postmarketing commitments, primarily for Celebrex and Pristiq. |
• | The unfavorable change in Other (income)/deductions––net in the first six months of 2015, compared to the same period in 2014, primarily reflects the non-recurrence of prior year gains on the sale of product rights. |
• | For Foreign currency translation adjustments, net, for the second quarter of 2015, reflects primarily the strengthening of the U.S. dollar against the euro, Japanese yen and Brazilian real, partially offset by the weakening of the U.S. dollar against the Canadian dollar; for the six months of 2015, reflects primarily the strengthening of the U.S. dollar against the euro, Brazilian real, Canadian dollar, Australian dollar, Mexican peso, Japanese yen, Denmark krone and Turkish lira. Also, for the first six months of 2014, includes the reclassification, into income, of amounts associated with legal entity dispositions. |
• | For Unrealized holding gains/(losses) on derivative financial instruments, net and Unrealized holding gains/(losses) on available-for-sale securities, net, reflects the impact of fair value remeasurements and the reclassification of realized amounts into income. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 7. Financial Instruments. |
• | For Benefit plans: actuarial gains/(losses), net, primarily reflects the reclassification into income of amounts related to (i) the amortization of changes in the pension benefit obligation previously recognized in Other comprehensive income and (ii) settlement activity, as well as the impact of foreign exchange. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10. Pension and Postretirement Benefit Plans. |
• | For Benefit plans: prior service credits and other, net, reflects a $507 million reduction in our U.S. Postretirement Plan obligation due to a plan amendment approved in June 2015 that introduced a cap on costs for certain groups within the plan, partially offset by the reclassification into income of amounts related to (i) amortization of changes in prior service costs and credits previously recognized in Other comprehensive income and (ii) curtailment activity. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10. Pension and Postretirement Benefit Plans. |
• | For Trade accounts receivable, less allowance for doubtful accounts, the change also reflects the timing of sales and collections in the normal course of business. |
• | For Inventories, the change also reflects inventory acquired as part of the acquisition of Baxter’s portfolio of marketed vaccines, recorded at acquisition date fair value, as well as inventory builds in advance of plant shutdowns/product transfers, partially offset by planned inventory reductions. |
• | For Property, plant and equipment, less accumulated depreciation (PP&E), the change also reflects depreciation, largely offset by capital additions in the normal course of business and, to a lesser extent, the PP&E assets acquired as part of the acquisition of Baxter’s portfolio of marketed vaccines. |
• | For Identifiable intangible assets, less accumulated amortization, the change reflects amortization, partially offset by identifiable intangible assets acquired as part of the acquisition of Baxter’s portfolio of marketed vaccines. For additional information about our intangible assets, see Notes to Condensed Consolidated Financial Statements—Note 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets. |
• | For Trade accounts payable, the change also reflects the timing of purchases and payments in the normal course of business. |
• | For Other current liabilities, the change also reflects payments of certain legal claims, as well as the timing of other payments and accruals in the normal course of business, partially offset by an increase in the payables associated with our derivative financial instruments. |
• | For Pension benefit obligations, net and Postretirement benefit obligations, net, the change also reflects, among other things, a $1.0 billion voluntary pension contribution in January 2015 and a $507 million reduction in our U.S. Postretirement Plan obligation due to a plan amendment approved in June 2015 that introduced a cap on costs for certain groups within the plan. For additional information about the net periodic pension cost, see Notes to Condensed Consolidated Financial Statements—Note 10. Pension and Postretirement Benefit Plans. |
• | For Other noncurrent liabilities, the change also reflects an increase in the payables associated with our derivative financial instruments and, to a lesser extent, the deferral of an upfront payment received from Eli Lilly & Company as part of a collaborative arrangement, partially offset by other payments and accruals in the normal course of business. |
Six Months Ended | |||||||||||
(MILLIONS OF DOLLARS) | June 28, 2015 | June 29, 2014 | % Change | ||||||||
Cash provided by/(used in): | |||||||||||
Operating activities | $ | 4,775 | $ | 7,022 | (32 | ) | |||||
Investing activities | 4,487 | (1,605 | ) | * | |||||||
Financing activities | (8,857 | ) | (4,173 | ) | * | ||||||
Effect of exchange-rate changes on cash and cash equivalents | (78 | ) | (21 | ) | * | ||||||
Net increase in Cash and cash equivalents | $ | 327 | $ | 1,223 | (73 | ) |
* | Calculation not meaningful. |
• | net redemptions of investments of $5.3 billion in the first six months of 2015, compared to net purchases of investments of $1.3 billion in the first six months of 2014, |
• | cash paid of $679 million, net of cash acquired, primarily for the acquisition of Baxter’s portfolio of marketed vaccines in the first six months of 2015 (see Notes to Condensed Consolidated Financial Statements—Note 2A. Acquisition, Collaborative Arrangements, Equity-Method Investment and Cost-Method Investment: Acquisition). |
• | purchases of common stock of $6.0 billion in the first six months of 2015, compared to $2.5 billion in the first six months of 2014; and |
• | net payments on borrowings of $509 million in the first six months of 2015, compared to net proceeds from borrowings of $1.0 billion in the first six months of 2014, |
• | proceeds from the exercise of stock options of $981 million in the first six months of 2015, compared to $583 million in the first six months of 2014. |
• | the working capital requirements of our operations, including our research and development activities; |
• | investments in our business; |
• | dividend payments and potential increases in the dividend rate; |
• | share repurchases; |
• | the cash requirements associated with our cost-reduction/productivity initiatives; |
• | paying down outstanding debt; |
• | contributions to our pension and postretirement plans; and |
• | business-development activities. |
The following table provides certain relevant measures of our liquidity and capital resources: | ||||||||
(MILLIONS OF DOLLARS, EXCEPT RATIOS AND PER COMMON SHARE DATA) | June 28, 2015 | December 31, 2014 | ||||||
Selected financial assets: | ||||||||
Cash and cash equivalents(a) | $ | 3,670 | $ | 3,343 | ||||
Short-term investments(a) | 26,586 | 32,779 | ||||||
Long-term investments(a) | 17,650 | 17,518 | ||||||
47,906 | 53,640 | |||||||
Debt: | ||||||||
Short-term borrowings, including current portion of long-term debt | 8,394 | 5,141 | ||||||
Long-term debt | 26,729 | 31,541 | ||||||
35,123 | 36,682 | |||||||
Net financial assets(b) | $ | 12,783 | $ | 16,958 | ||||
Working capital | $ | 27,572 | $ | 36,071 | ||||
Ratio of current assets to current liabilities | 2.14 | :1 | 2.67 | :1 | ||||
Total Pfizer Inc. shareholders’ equity per common share(c) | $ | 10.86 | $ | 11.33 |
(a) | See Notes to Condensed Consolidated Financial Statements––Note 7. Financial Instruments for a description of certain assets held and for a description of the credit risk related to our financial instruments held. |
(b) | Net financial assets decreased as net cash provided by operating activities decreased, and dividend payments and share purchases, among other things, more than offset the redemptions/sales net of purchases of investments and proceeds from the exercise of stock options. For additional information, see the “Analysis of the Condensed Consolidated Statements of Cash Flows” section of this MD&A. |
(c) | Represents total Pfizer Inc. shareholders’ equity divided by the actual number of common shares outstanding (which excludes treasury stock). |
The following table provides the current ratings assigned by these rating agencies to our commercial paper and senior unsecured non-credit-enhanced long-term debt: | |||||||
NAME OF RATING AGENCY | Pfizer Commercial Paper | Pfizer Long-Term Debt | Date of Last Rating Change | ||||
Rating | Rating | Outlook | |||||
Moody’s | P-1 | A1 | Stable | October 2009 | |||
S&P | A-1+ | AA | Stable | October 2009 |
The following table provides the number of shares of our common stock purchased and the cost of purchases under our publicly announced share-purchase plans, including our accelerated share repurchase agreement: | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
(SHARES IN MILLIONS, DOLLARS IN BILLIONS) | June 28, 2015 | June 29, 2014 | June 28, 2015(a) | June 29, 2014 | |||||||||||
Shares of common stock purchased | — | 44 | 182 | 82 | |||||||||||
Cost of purchase | — | $ | 1.3 | $ | 6.0 | $ | 2.5 |
The following table provides a brief description of recently issued accounting standards, not yet adopted: | ||||||
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In November 2014, Financial Accounting Standards Board (FASB) issued amended guidance related to accounting for hybrid financial instruments issued or held as investments. | The new guidance clarifies that for hybrid financial instruments in the form of stock, the assessment of whether the embedded derivative is clearly and closely related to the host instrument must consider the economic characteristics and risks of the entire hybrid financial instrument, including the embedded derivative feature that is being evaluated for separate accounting from the host contract. | January 1, 2016 | We do not expect that the provisions of this new standard will have any material impact on our consolidated financial statements. | |||
In August 2014, the FASB issued amended guidance related to disclosure of uncertainties about the ability of an entity to continue as a going concern. | The new guidance requires management of all entities to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, as necessary, to provide related footnote disclosures. | December 31, 2016 | We do not expect that the provisions of this new standard will have any impact on our consolidated financial statements. | |||
In May 2014, the FASB issued amended guidance related to revenue from contracts with customers. | The new guidance introduces a new principles-based framework for revenue recognition and disclosure. | January 1, 2017. Early adoption is not permitted.(a) | We have not yet decided on a method of adoption (full retrospective or modified retrospective basis) and we have not yet determined the potential impact, if any, of this standard on our consolidated financial statements. | |||
In July 2015, the FASB issued an update related to inventory. | The new guidance requires that inventory be measured at the lower of cost or net realizable value. | January 1, 2017 | We do not expect the provisions of this new standard will have a material impact on our consolidated financial statements. |
(a) | In April 2015, the FASB issued an exposure draft to propose a one-year deferral of the effective date. At its July 9, 2015 meeting, the FASB agreed to defer by one year the mandatory effective date of its revenue recognition standard, but will also provide entities the option to adopt it as of the original effective date. |
• | the outcome of research and development activities including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; |
• | decisions by regulatory authorities regarding whether and when to approve our drug applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; and decisions by regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our products; |
• | the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; |
• | the outcome of post-approval clinical trials, which could result in the loss of marketing approval for a product or changes in the labeling for, and/or increased or new concerns about the safety or efficacy of, a product that could affect its availability or commercial potential; |
• | risks associated with interim data, including the risk that final results of studies for which interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development of the applicable product candidate or indication; |
• | the success of external business-development activities, including the ability to satisfy the conditions to closing of announced transactions in the anticipated timeframe or at all, including our and Hospira’s ability to satisfy the conditions to closing our merger agreement; |
• | competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates; |
• | the implementation by the FDA of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products in the U.S., with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights; |
• | the ability to meet generic and branded competition after the loss of patent protection for our products or competitor products; |
• | the ability to successfully market both new and existing products domestically and internationally; |
• | difficulties or delays in manufacturing; |
• | trade buying patterns; |
• | the impact of existing and future legislation and regulatory provisions on product exclusivity; |
• | trends toward managed care and healthcare cost containment; |
• | the impact of any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented, and/or any significant additional taxes or fees that may be imposed on the pharmaceutical industry as part of any broad deficit-reduction effort; |
• | the impact of U.S. healthcare legislation enacted in 2010—the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act––and of any modification or repeal of any of the provisions thereof; |
• | U.S. federal or state legislation or regulatory action affecting, among other things, pharmaceutical product pricing, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; direct-to-consumer advertising and interactions with healthcare professionals; and the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines; as well as pricing pressures as a result of highly competitive insurance markets; |
• | legislation or regulatory action in markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access, including, in particular, continued government-mandated price reductions for certain biopharmaceutical products and government-imposed access restrictions in certain countries; |
• | the exposure of our operations outside the U.S. to possible capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest and unstable governments and legal systems; |
• | contingencies related to actual or alleged environmental contamination; |
• | claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates; |
• | any significant breakdown, infiltration or interruption of our information technology systems and infrastructure; |
• | legal defense costs, insurance expenses, settlement costs, the risk of an adverse decision or settlement and the adequacy of reserves related to product liability, patent protection, government investigations, consumer, commercial, securities, antitrust, environmental and tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings; |
• | our ability to protect our patents and other intellectual property, both domestically and internationally; |
• | interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates; |
• | governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals; |
• | any significant issues involving our largest wholesaler customers, which account for a substantial portion of our revenues; |
• | the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines; |
• | any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards; |
• | any significant issues that may arise related to our joint ventures and other third-party business arrangements; |
• | changes in U.S. generally accepted accounting principles; |
• | uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; and the related risk that our allowance for doubtful accounts may not be adequate; |
• | any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas; |
• | growth in costs and expenses; |
• | changes in our product, segment and geographic mix; and |
• | the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including those related to our research and development organization, of the internal separation of our commercial operations into our new operating structure and of our pending acquisition of Hospira. |
Period | Total Number of Shares Purchased(b) | Average Price Paid per Share(b) | Total Number of Shares Purchased as Part of Publicly Announced Plan | Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plan(a) | ||||||
March 30, 2015 through April 26, 2015 | 15,272 | $ | 34.59 | — | $ | 5,516,045,698 | ||||
April 27, 2015 through May 24, 2015 | 24,543 | $ | 34.29 | — | $ | 5,516,045,698 | ||||
May 25, 2015 through June 28, 2015 | 42,679 | $ | 34.32 | — | $ | 5,516,045,698 | ||||
Total | 82,494 | $ | 34.36 | — |
(a) | On June 27, 2013, we announced that the Board of Directors had authorized a $10 billion share-purchase plan, which was exhausted in the first quarter of 2015 (the June 2013 Stock Purchase Plan). On October 23, 2014, we announced that the Board of Directors had authorized an additional $11 billion share-purchase plan, and share purchases commenced thereunder in January 2015 (the October 2014 Stock Purchase Plan). On February 9, 2015, we entered into an accelerated share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to repurchase shares of our common stock. This agreement was entered into under our previously announced share repurchase authorization. Pursuant to the terms of the agreement, on February 11, 2015, we paid $5 billion to GS&Co. and received approximately 150 million shares of our common stock from GS&Co. On July 2, 2015, the accelerated share repurchase agreement with GS&Co. was completed, which, per the terms of the agreement, resulted in us owing GS&Co. a certain number of shares of Pfizer common stock or its equivalent dollar value. Pursuant to the agreement’s settlement terms, we elected to settle this amount in cash and paid an additional $160 million to GS&Co. on July 13, 2015, resulting in a total of approximately $5.2 billion paid to GS&Co. After giving effect to this accelerated share repurchase agreement, as well as other share repurchases to date in 2015, our remaining share-purchase authorization is approximately $5.4 billion. We do not currently expect to repurchase additional shares this year. |
(b) | These columns reflect the following transactions during the second fiscal quarter of 2015: (i) the surrender to Pfizer of 46,162 shares of common stock to satisfy tax withholding obligations in connection with the vesting of restricted stock units issued to employees; (ii) the open market purchase by the trustee of 18,896 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who were granted performance share awards and who deferred receipt of such awards; (iii) the surrender to Pfizer of 5,126 shares of common stock to satisfy tax withholding obligations in connection with the vesting of performance share awards issued to employees; and (iv) the surrender to Pfizer of 12,310 shares of common stock to pay the exercise price and to satisfy tax withholding obligations in connection with the exercise of employee stock options. |
Exhibit 12 | - | Computation of Ratio of Earnings to Fixed Charges. | |
Exhibit 15 | - | Accountants’ Acknowledgment. | |
Exhibit 31.1 | - | Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
Exhibit 31.2 | - | Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
Exhibit 32.1 | - | Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
Exhibit 32.2 | - | Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
Exhibit 101: | |||
EX-101.INS EX-101.SCH EX-101.CAL EX-101.LAB EX-101.PRE EX-101.DEF | XBRL Instance Document XBRL Taxonomy Extension Schema XBRL Taxonomy Extension Calculation Linkbase XBRL Taxonomy Extension Label Linkbase XBRL Taxonomy Extension Presentation Linkbase XBRL Taxonomy Extension Definition Document |
Pfizer Inc. | ||
(Registrant) | ||
Dated: | August 6, 2015 | /s/ Loretta V. Cangialosi |
Loretta V. Cangialosi, Senior Vice President and Controller (Principal Accounting Officer and Duly Authorized Officer) |