EX-13 5 pfe-12312015x10kexhibit13.htm 2015 FINANCIAL REPORT Exhibit
EXHIBIT 13

Pfizer Inc. 2015 Financial Report
 
 



Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

INTRODUCTION

Our Financial Review is provided to assist readers in understanding the results of operations, financial condition and cash flows of Pfizer Inc. (the Company). It should be read in conjunction with the consolidated financial statements and Notes to Consolidated Financial Statements. The discussion in this Financial Review contains forward-looking statements that involve substantial risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, such as those discussed in Part 1, Item 1A, “Risk Factors” of our 2015 Annual Report on Form 10-K and in the “Forward-Looking Information and Factors That May Affect Future Results”, “Our Operating Environment” and “Our Strategy” sections of this Financial Review.

The Financial Review is organized as follows:
Beginning on page 2
 
This section provides information about the following: Our Business; Our 2015 Performance; Our Operating Environment; The Global Economic Environment, Our Strategy; Our Business Development Initiatives, such as acquisitions, dispositions, licensing and collaborations; and Our Financial Guidance for 2016.
 
Beginning on page 12
 
This section discusses those accounting policies and estimates that we consider important in understanding our consolidated financial statements. For additional discussion of our accounting policies, see Notes to Consolidated Financial Statements—Note 1. Basis of Presentation and Significant Accounting Policies.
 
Beginning on page 19
 
This section includes a Revenues Overview section as well as the following sub-sections:
 
Beginning on page 24
 
This sub-section provides an overview of several of our biopharmaceutical products.
 
 
Beginning on page 28
 
This sub-section provides an overview of important biopharmaceutical product developments.
 
 
Beginning on page 31
 
This sub-section provides a discussion about our costs and expenses.
 
 
Beginning on page 34
 
This sub-section provides a discussion of items impacting our tax provisions.
 
 
Beginning on page 35
 
Beginning on page 35
 
This sub-section provides a discussion of an alternative view of performance used by management.
 
Beginning on page 42
 
This section provides a discussion of the performance of each of our operating segments.
 
Beginning on page 48
 
This section provides a discussion of changes in certain components of other comprehensive income.
 
Beginning on page 49
 
This section provides a discussion of changes in certain balance sheet accounts, including Accumulated other comprehensive loss.
 
Beginning on page 50
 
This section provides an analysis of our consolidated cash flows for the three years ended December 31, 2015.
 
Beginning on page 51
 
This section provides an analysis of selected measures of our liquidity and of our capital resources as of December 31, 2015 and December 31, 2014, as well as a discussion of our outstanding debt and other commitments that existed as of December 31, 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.
 
Beginning on page 56
 
This section discusses accounting standards that we have recently adopted, as well as those that recently have been issued, but not yet adopted.
 
Beginning on page 58
 
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 Financial Review 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. Also included in this section are discussions of Financial Risk Management and Contingencies, including legal and tax matters.
 
Certain amounts in our Financial Review may not add due to rounding. All percentages have been calculated using unrounded amounts.

2015 Financial Report    
 
 
1


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK

Our Business

We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines, vaccines and medical devices, as well as many of the world’s best-known consumer healthcare products. We work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. Our revenues are derived from the sale of our products and, to a much lesser extent, from alliance agreements, under which we co-promote products discovered by other companies (Alliance revenues).

The majority of our revenues come from the manufacture and sale of biopharmaceutical products. The biopharmaceutical industry is highly competitive and highly regulated. As a result, we face a number of industry-specific factors and challenges which can significantly impact our results. These factors include, among others: the loss or expiration of intellectual property rights and the expiration of co-promotion and licensing rights, healthcare legislation, pipeline productivity, the regulatory environment, pricing and access pressures and competition. We also face challenges as a result of the global economic environment. For additional information about these factors and challenges, see the “Our Operating Environment” section of this Financial Review and in Part I, Item 1A, “Risk Factors,” of our 2015 Annual Report on Form 10-K.

The financial information included in our consolidated financial statements for our subsidiaries operating outside the United States (U.S.) is as of and for the year ended November 30 for each year presented. Pfizer's fiscal year-end for U.S. subsidiaries is as of and for the year ended December 31 for each year presented.

References to developed markets in this Financial Review include the U.S., Western Europe, Japan, Canada, Australia, Scandinavia, South Korea, Finland and New Zealand; and references to emerging markets in this Financial Review include, but are not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Africa, Eastern Europe, Central Europe, the Middle East and Turkey.

References to operational variances in this Financial Review refer to variances excluding the impacts of foreign exchange.

On November 23, 2015, we announced that we have entered into a definitive merger agreement with Allergan plc (Allergan), a global pharmaceutical company incorporated in Ireland, under which we have agreed to combine with Allergan in a stock transaction valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015 (the last trading day prior to the announcement) and certain other assumptions. Subject to the terms and conditions of the merger agreement, the businesses of Pfizer and Allergan will be combined under a single company and Pfizer would become a wholly-owned subsidiary of Allergan, which is organized under the laws of Ireland and which, subject to the approval by Allergan shareholders, will be renamed “Pfizer plc”. We anticipate that the parent company will be treated as a non-U.S. corporation (and, therefore, a non-U.S. tax resident) under the applicable U.S. federal income tax rules, although the U.S. Internal Revenue Service (IRS) may challenge that treatment. The completion of the transaction, which is expected in the second half of 2016, is subject to certain conditions, including receipt of regulatory approval in certain jurisdictions, including the U.S. and European Union (EU), the receipt of necessary approvals from both Pfizer and Allergan shareholders, and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Industries Ltd. Readers are encouraged to review the joint proxy statement/prospectus we will file with the U.S. Securities and Exchange Commission (SEC) seeking stockholder approval of the transaction. That document will include important information regarding the proposed transaction. While we have taken actions and incurred costs associated with the pending combination that are reflected in our financial statements, the pending combination with Allergan will not be reflected in our financial statements until consummation. See the “Our Business Development Initiatives” section of this Financial Review and Notes to Consolidated Financial Statements––Note 19. Pending Combination with Allergan for additional information.
On September 3, 2015 (the acquisition date), we acquired Hospira, Inc. (Hospira) for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired). Commencing from the acquisition date, our financial statements reflect the assets, liabilities, operating results and cash flows of Hospira, and, in accordance with our domestic and international reporting periods, our consolidated financial statements for the year ended December 31, 2015 reflect four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations. See Notes to Consolidated Financial Statements––Note 2A. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions and the “Significant Accounting Policies and Application of Critical Accounting Estimates––Acquisition of Hospira” section of this Financial Review for additional information. Hospira is now a subsidiary of Pfizer and its commercial operations are now included within the Global Established Pharmaceutical (GEP) segment. The combination of local Pfizer and Hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps. We expect to generate $800 million of annual cost synergies by 2018 in connection with the Hospira acquisition. Based on our past experience, the one-time costs to generate the synergies are expected to be approximately $1 billion (not including costs of $215 million in 2015 associated with the return of acquired in-process research and development (IPR&D) rights), incurred for up to a three-year period post-acquisition. See the “Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this Financial Review.

On June 24, 2013, we completed the full disposition of our Animal Health business, Zoetis Inc. (Zoetis), and recognized a gain of approximately $10.3 billion, net of tax, in Gain on disposal of discontinued operations––net of tax in our consolidated statement of income for the year ended December 31, 2013. The operating results of this business through June 24, 2013, the date of disposal, are reported as Income from discontinued operations––net of tax in our consolidated statements of income. See Notes to Consolidated Financial Statements––Note 2D. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Divestitures for additional information.

2
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Our 2015 Performance

Revenues––2015

Revenues in 2015 were $48.9 billion, a decrease of 2% compared to 2014. This reflects an operational increase of $3.0 billion, or 6%, which was more than offset by the unfavorable impact of foreign exchange of $3.8 billion, or 8%.
The following provides an analysis of our 2015 operational revenue growth for Pfizer standalone revenues:
 
 
Year Ended December 31,
(BILLIONS OF DOLLARS)
 
2015

Operational revenues––Pfizer-standalone increase:
 
 
Operational consolidated revenues increase
 
$
3.0

Less: Revenues from legacy Hospira
 
(1.5
)
Revenues from vaccines acquired from Baxter
 
(0.2
)
Operational revenues––Pfizer-standalone increase
 
$
1.3

 
 
 
Components of operational revenues––Pfizer-standalone increase:
 
 
Operational revenue growth from certain key products––net
 
$
4.5

Operational revenue decrease due to product losses of exclusivity and co-promotion expirations
 
(3.2
)
Operational revenues––Pfizer-standalone increase
 
$
1.3


See the “Analysis of the Consolidated Statements of Income––Revenues––Overview” section below for more information, including a discussion of key drivers of our revenue performance.

Income from Continuing Operations Before Provision for Taxes on Income––2015

Income from continuing operations before provision for taxes on income was $9.0 billion in 2015 compared to $12.2 billion in 2014, primarily reflecting, among other items, in addition to the operational and foreign exchange impacts for Revenues described above:
higher restructuring charges and certain acquisition-related costs (up $902 million) (see also the Notes to Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives);
foreign currency loss ($806 million) and an inventory impairment charge ($72 million) related to Venezuela in 2015 (see also the “Costs and Expenses––Cost of Sales” and the “Analysis of Financial Condition, Liquidity and Capital Resources––Global Economic Conditions––Venezuela Operations” sections of this Financial Review and Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net);
higher selling, informational and administrative expenses (up $711 million) (see also the “Costs and Expenses––Selling, Informational and Administrative Expenses (SI&A) Expenses” section of this Financial Review);
higher Other, net (up $668 million) (see also the Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net);
higher asset impairments (up $349 million) (see also the Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net); and
higher charges for business and legal entity alignment activities (up $114 million) (see also the Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net),
partially offset by:

lower research and development expenses (down $703 million) (see also the “Costs and Expenses––Research and Development (R&D) Expenses” section of this Financial Review);
lower amortization of intangible assets (down $311 million) (see also the “Costs and Expenses––Amortization of Intangible Assets” section of this Financial Review); and
lower net interest expense (down $207 million) (see also the Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net).
For information on our tax provision and effective tax rate see the “Provision for Taxes on Income” section of the Financial Review and Notes to Consolidated Financial Statements––Note 5. Tax Matters.
Our Operating Environment

Industry-Specific Challenges

Intellectual Property Rights and Collaboration/Licensing Rights

The loss or expiration of intellectual property rights and the expiration of co-promotion and licensing rights can have a significant adverse effect on our revenues. Many of our branded products have multiple patents that expire at varying dates, thereby strengthening our overall patent protection. However, once patent protection has expired or has been lost prior to the expiration date as a result of a legal challenge, we

2015 Financial Report    
 
 
3


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

lose exclusivity on these products, and generic pharmaceutical manufacturers generally produce similar products and sell them for a lower price. The date at which generic competition commences may be different from the date that the patent or regulatory exclusivity expires. However, when generic competition does commence, the resulting price competition can substantially decrease our revenues for the impacted products, often in a very short period of time.

Our biotechnology products, including BeneFIX, ReFacto, Xyntha and Enbrel (we market Enbrel outside the U.S. and Canada), may face competition in the future from biosimilars (also referred to as follow-on biologics). If competitors are able to obtain marketing approval for biosimilars that reference our biotechnology products, our biotechnology products may become subject to competition from these biosimilars, with attendant competitive pressure, and price reductions could follow. Expiration or successful challenge of applicable patent rights could trigger this competition, assuming any relevant exclusivity period has expired. However, biosimilar manufacturing is complex. At least initially upon approval of a biosimilar competitor, biosimilar competition with respect to biologics may not be as significant as generic competition with respect to small molecule drugs.

We have lost exclusivity for a number of our products in certain markets and we have lost collaboration rights with respect to a number of our alliance products in certain markets, and we expect certain products and alliance products to face significantly increased generic competition over the next few years.

Specifically:

Recent Losses and Expected Losses of Product Exclusivity
The following table provides information about certain of our products recently experiencing, or expected to experience in 2016, patent expirations or loss of regulatory exclusivity in the U.S., Europe or Japan, showing, by product, the key dates or expected key dates, the markets impacted and the revenues associated with those products in those markets:
(MILLIONS OF DOLLARS)
 
 
 
 
 
Product Revenues in Markets Impacted
Products
 
Key Dates(a)
 
Markets Impacted
 
Year Ended December 31,
 
 
 
 
 
 
2015

 
2014

 
2013

Detrol IR and Detrol LA(b)
 
September 2012
January 2014
 
Major European markets
U.S.
 
$
35

 
$
87

 
$
428

Viagra
 
June 2013
May 2014
 
Major European markets
Japan
 
76

 
120

 
310

Rapamune
 
January 2014
June 2015
 
U.S.
Major European markets
 
129

 
254

 
253

Inspra(c)
 
March 2014
 
Major European markets
 
74

 
160

 
150

Lyrica(d)
 
July 2014
 
Major European markets
 
1,048

 
1,634

 
1,458

Celebrex(e)
 
November 2014
December 2014
 
Major European markets
U.S.
 
189

 
1,872

 
2,084

Zyvox(f)
 
First half of 2015
January 2016
 
U.S.
Major European markets
 
564

 
1,020

 
1,013

Enbrel(g)
 
August 2015
September 2015
 
Major European markets
Japan
 
2,402

 
2,832

 
2,776

Relpax
 
December 2016
 
U.S.
 
233

 
244

 
218

Vfend
 
July 2016
January 2016
 
Major European markets
Japan
 
349

 
403

 
413

Tygacil
 
April 2016
 
U.S.
 
110

 
112

 
150

(a) 
Unless stated otherwise, “Key Dates” indicate patent-based expiration dates.
(b) 
In January 2014, generic versions of Detrol LA became available in the U.S. pursuant to a settlement agreement.
(c) 
In March 2014, regulatory exclusivity for Inspra expired in most major European markets, allowing generic companies to submit applications for marketing authorizations for their generic products.
(d) 
In July 2014, regulatory exclusivity for Lyrica expired in the EU, allowing generic companies to submit applications for marketing authorizations for their generic products.
(e) 
In December 2014, generic versions of Celebrex became available pursuant to settlement agreements with several generic manufacturers.
(f) 
Pursuant to terms of a settlement agreement, certain formulations of Zyvox became subject to generic competition in the U.S. in January 2015. Other formulations of Zyvox became subject to generic competition in the U.S. in the first half of 2015.
(g) 
In January 2016, the European Commission approved an etanercept biosimilar referencing Enbrel.


4
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Recent Losses and Expected Losses of Collaboration Rights
The following table provides information about certain of our alliance revenue products that have experienced or that are expected to experience in 2016 losses of collaboration rights, showing, by product, the date of the loss of the collaboration rights, the markets impacted and the alliance revenues associated with those products in those markets:
(MILLIONS OF DOLLARS)
 
 
 
 
 
Alliance Revenues in
Markets Impacted
Products
 
Date of Loss of
Collaboration Rights
 
Markets Impacted
 
Year Ended December 31,
 
 
 
 
 
 
2015

 
2014

 
2013

Spiriva(a)
 
April 2014 (U.S.), between 2012 and 2016 (Japan, certain European countries, Australia, Canada and South Korea)
 
U.S., Japan, certain European countries, Australia, Canada and South Korea
 
$
27

 
$
168

 
$
659

Enbrel(b)
 
October 2013
 
U.S. and Canada
 

 
3

 
1,400

Rebif(c)
 
End of 2015
 
U.S.
 
371

 
415

 
401

(a) 
Our collaboration with Boehringer Ingelheim for Spiriva expires on a country-by-country basis between 2012 and 2016. On April 29, 2014, our alliance in the U.S. came to an end.
(b) 
The U.S. and Canada co-promotion term of our collaboration agreement with Amgen Inc. for Enbrel expired on October 31, 2013. While we are entitled to royalties until October 31, 2016, those royalties have been and are expected to continue to be significantly less than our share of Enbrel profits from U.S. and Canada sales prior to the expiration. In addition, while our share of the profits from this co-promotion agreement previously was included in Revenues, our royalties after October 31, 2013 are and will be included in Other (income)/deductions––net, in our consolidated statements of income. Outside the U.S. and Canada, we continue to have the exclusive rights to market Enbrel.
(c) 
Our collaboration agreement with EMD Serono Inc. to co-promote Rebif in the U.S. expired at the end of 2015.

In addition, we expect to lose exclusivity for various other products in various markets over the next few years. For additional information, see the “Patents and Other Intellectual Property Rights” section in Part I, Item 1, “Business”, of our 2015 Annual Report on Form 10-K.

Our financial results in 2015 and our 2016 financial guidance, respectively, reflect the impact and projected impact of the loss of exclusivity of various products and the expiration of certain alliance product contract rights discussed above. For additional information about our 2016 financial guidance, see the “Our Financial Guidance for 2016” section of this Financial Review.

We will continue to aggressively defend our patent rights whenever we deem appropriate. For more detailed information about our significant products, see the discussion in the “Revenues––Major Products” and “Revenues––Selected Product Descriptions” sections of this Financial Review. For a discussion of certain recent developments with respect to patent litigation, see Notes to Consolidated Financial Statements––Note 17A1. Commitments and Contingencies: Legal Proceedings––Patent Litigation.

Regulatory Environment/Pricing and Access––U.S. Healthcare Legislation

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (together, the U.S. Healthcare Legislation, and also known as the Affordable Care Act or ACA), was enacted in the U.S. For additional information, see the “Government Regulation and Price Constraints” section in Part I, Item 1, “Business”, of our 2015 Annual Report on Form 10-K. The U.S. Healthcare Legislation also created a framework for the approval of biosimilars (also known as follow-on biologics) following the expiration of 12 years of exclusivity for the innovator biologic, with a potential six-month pediatric extension. For additional information on the biosimilar approval pathway, the U.S. Food and Drug Administration’s (FDA) guidance documents and competition from biosimilar manufacturers, see the “Patents and Intellectual Property—Biotechnology Products” and “Government Regulation and Price Constraints—Biosimilar Regulation” sections in Part I, Item 1 “Business”, of our 2015 Annual Report on Form 10-K.

Impacts on our 2015 Results

We recorded the following amounts in 2015 as a result of the U.S. Healthcare Legislation:
$977 million recorded as a reduction to Revenues, related to the higher, extended and expanded rebate provisions and the Medicare “coverage gap” discount provision, as well as an increase in Medicaid rebates; and
$251 million 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 decrease in the impact of the U.S. Healthcare Legislation on Selling, informational and administrative expenses in 2015 compared to 2014 was primarily a result of the non-recurrence of the $215 million charge in 2014 to account for an additional year of the non-tax deductible Branded Prescription Drug Fee, partially offset by a lower favorable true-up in 2015, compared to the favorable true-up in 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.


2015 Financial Report    
 
 
5


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Impacts on our 2014 Results

We recorded the following amounts in 2014 as a result of the U.S. Healthcare Legislation:
$631 million recorded as a reduction to Revenues, related to the higher, extended and expanded rebate provisions and the Medicare “coverage gap” discount provision; and
$362 million recorded in Selling, informational and administrative expenses, related to the fee payable to the federal government. 2014 included a $215 million charge to account for an additional year of the non-tax deductible Branded Prescription Drug Fee in accordance with final regulations issued in the third quarter of 2014 by the IRS. The amount in 2014 also reflected a favorable true-up associated with the final 2013 invoice received from the federal government, which reflected a lower share than that of the initial 2013 invoice.
The final regulations issued by the IRS did not change the payment schedule for the Branded Prescription Drug Fee; accordingly there was no cash flow impact in 2014 from the $215 million charge.

Impacts on our 2013 Results

We recorded the following amounts in 2013 as a result of the U.S. Healthcare Legislation:
$458 million recorded as a reduction to Revenues, related to the higher, extended and expanded rebate provisions and the Medicare “coverage gap” discount provision; and
$280 million recorded in Selling, informational and administrative expenses, related to the fee payable to the federal government.

Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures

Governments, managed care organizations and other payer groups continue to seek increasing discounts on our products through a variety of means, such as leveraging their purchasing power, implementing price controls, and demanding price cuts (directly or by rebate actions). In Europe, Japan, China, Canada, South Korea and some other international markets, governments provide healthcare at low direct cost to patients and regulate pharmaceutical prices or patient reimbursement levels to control costs for the government-sponsored healthcare system. In the U.S., a primary government activity with implications for pharmaceutical pricing is deficit reduction. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented, and/or any significant additional taxes or fees that may be imposed on us, as part of any broad deficit-reduction effort could have an adverse impact on our results of operations.

Additionally, policy efforts designed specifically to reduce patient out-of-pocket costs for medicines could result in new mandatory rebates and discounts or other pricing restrictions. A number of the candidates for the 2016 U.S. presidential elections have introduced such policy proposals, and a November 2015 U.S. Department of Health and Human Services forum dedicated to drug pricing could lead to further proposals. We believe medicines are the most efficient and effective use of healthcare dollars based on the value they deliver to the overall healthcare system. We continue to work with stakeholders in an effort to ensure access to medicines within an efficient and affordable healthcare system. In addition, certain regulatory changes to be implemented in 2016 may affect Pfizer's obligations under the Medicaid drug rebate program, but the impact of those changes is not yet known.

The ACA, which expanded the role of the U.S. government as a healthcare payer, is accelerating changes in the U.S. healthcare marketplace, and the potential for additional pricing and access pressures continues to be significant. Many of these developments may impact drug utilization, in particular branded drug utilization. Some employers, seeking to avoid the tax on high-cost health insurance in the ACA originally to be imposed in 2018 (now to be imposed in 2020, per the terms of the fiscal year 2016 omnibus appropriations legislation), are already scaling back healthcare benefits. Some health plans and pharmacy benefit managers are seeking greater pricing predictability from pharmaceutical manufacturers in contractual negotiations. Other health plans and pharmacy benefit managers are increasing their focus on spending on specialty medicines by implementing co-insurance in place of a flat co-payment. Because co-insurance passes on a percentage of a drug’s cost to the patient, this shift has the potential to significantly increase patient out-of-pocket costs.

Overall, there is increasing pressure on U.S. providers to deliver healthcare at a lower cost and to ensure that those expenditures deliver demonstrated value in terms of health outcomes. Longer term, we are seeing a shift in focus away from fee-for-service payments towards outcomes-based payments and risk-sharing arrangements that reward providers for cost reductions. These new payment models can, at times, lead to lower prices for, and restricted access to, new medicines. At the same time, these models can also expand utilization by encouraging physicians to screen, diagnose and focus on outcomes.

In response to the evolving U.S. and global healthcare spending landscape, we are continuing to work with health authorities, health technology assessment and quality measurement bodies and major U.S. payers throughout the product-development process to better understand how these entities value our compounds and products. Further, we are seeking to develop stronger internal capabilities focused on demonstrating the value of the medicines that we discover or develop, register and manufacture, by recognizing patterns of usage of our medicines and competitor medicines along with patterns of healthcare costs.

Regulatory Environment––Pipeline Productivity

The discovery and development of safe, effective new products, as well as the development of additional uses for existing products, are necessary for the continued strength of our businesses. We have encountered increasing regulatory scrutiny of drug safety and efficacy, even as we continue to gather safety and other data on our products, before and after the products have been launched. Our product lines must be replenished over time in order to offset revenue losses when products lose their market exclusivity, as well as to provide for earnings growth. We devote considerable resources to R&D activities. These activities involve a high degree of risk and cost and may take many years, and

6
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

with respect to any specific R&D project, there can be no assurance that the development of any particular product candidate or new indication for an in-line product will achieve desired clinical endpoints and safety profile, will be approved by regulators or will be successful commercially. We continue to strengthen our global R&D organization and pursue strategies intended to improve innovation and overall productivity in R&D to achieve a sustainable pipeline that will deliver value in the near term and over time.

During the development of a product, we conduct clinical trials to provide data on the drug’s safety and efficacy to support the evaluation of its overall benefit-risk profile for a particular patient population. In addition, after a product has been approved and launched, we continue to monitor its safety as long as it is available to patients, and post-marketing trials may be conducted, including trials requested by regulators and trials that we do voluntarily to gain additional medical knowledge. For the entire life of the product, we collect safety data and report potential problems to the FDA and other regulatory authorities. The FDA and regulatory authorities in other jurisdictions may evaluate potential safety concerns related to a product or a class of products and take regulatory actions in response, such as updating a product’s labeling, restricting the use of a product, communicating new safety information to the public, or, in rare cases, removing a product from the market.

Competition

Many of our prescription pharmaceutical products face competition in the form of branded or generic drugs that treat similar diseases or indications. For additional information, see the “Competition” section in Part I, Item 1, “Business”, of our 2015 Annual Report on Form 10-K.
The Global Economic Environment

In addition to industry-specific factors discussed above, we, like other businesses, are exposed to the economic cycle, which impacts our biopharmaceutical operations globally.
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 economic 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 Financial Review.
Significant portions of our revenues and earnings, as well as our substantial international net 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 a negative impact on earnings, and our overall expenses would decrease, having a positive impact on earnings. Therefore, significant changes in foreign exchange rates can impact our results and our financial guidance.
The impact of possible currency devaluations in countries experiencing high inflation rates or significant exchange fluctuations, including Venezuela, can impact our results and financial guidance. In 2015, we recorded a foreign currency loss of $806 million and an inventory impairment charge of $72 million related to recent conditions in Venezuela. For further information about our exposure to foreign currency risk, see the “Analysis of Financial Condition, Liquidity and Capital Resources” and the “Our Financial Guidance for 2016” sections of this Financial Review. For further information about our foreign currency losses related to Venezuela, see Notes to Consolidated Financial Statements––Note 4. Other (Income)/Deductions––Net.

Despite the challenging financial markets, Pfizer maintains a strong financial position. Due to our significant operating cash flows, financial assets, access to capital markets and available lines of credit and revolving credit agreements, we continue to believe that we have, and will maintain, the ability to meet our liquidity needs for the foreseeable future. Our long-term debt is rated high quality by both Standard & Poor’s (S&P) and Moody’s Investors Service (Moody’s). As market conditions change, we continue to monitor our liquidity position. We have taken and will continue to take a conservative approach to our financial investments. Both short-term and long-term investments consist primarily of high-quality, highly liquid, well-diversified, available-for-sale debt securities. For further discussion about our financial condition, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this Financial Review.

These and other industry-wide factors that may affect our businesses should be considered along with information presented in the “Forward-Looking Information and Factors That May Affect Future Results” section of this Financial Review and in Part I, Item 1A, “Risk Factors,” of our 2015 Annual Report on Form 10-K.

2015 Financial Report    
 
 
7


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Our Strategy

We believe that our medicines provide significant value for both healthcare providers and patients, not only from the improved treatment of diseases but also from a reduction in other healthcare costs, such as emergency room or hospitalization costs, as well as improvements in health, wellness and productivity. We continue to actively engage in dialogues about the value of our products and how we can best work with patients, physicians and payers to prevent and treat disease and improve outcomes. We continue to work within the current legal and pricing structures, as well as continue to review our pricing arrangements and contracting methods with payers, to maximize access to patients and minimize any adverse impact on our revenues. We remain firmly committed to fulfilling our company’s purpose of innovating to bring therapies to patients that extend and significantly improve their lives. By doing so, we expect to create value for the patients we serve and for our shareholders.

Commercial Operations

We manage our commercial operations through two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business is composed of two operating segments, each of which has been led by a single manager in 2015 and 2014––the Global Innovative Pharmaceutical segment (GIP) and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC). Effective February 8, 2016, the Innovative Products business is led by a single manager. The Established Products business consists of the Global Established Pharmaceutical segment (GEP), which is also led by a single manager. Each operating segment has responsibility for its commercial activities and for certain IPR&D projects for new investigational products and additional indications for in-line products that generally have achieved proof of concept. Each business has a geographic footprint across developed and emerging markets.
Some additional information about each business and operating segment follows:
Innovative Products Business
 
Established Products Business
Global Innovative Pharmaceutical segment:
GIP focuses on developing and commercializing novel, value-creating medicines that significantly improve patients’ lives. Key therapeutic areas include inflammation/immunology, cardiovascular/metabolic, neuroscience/pain and rare diseases and include leading brands, such as Xeljanz, Eliquis, Lyrica (U.S. and Japan), Enbrel (outside the U.S. and Canada) and Viagra (U.S. and Canada).
 
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 legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded generics, generic sterile injectable products, biosimilars and infusion systems. 

We expect that the GIP and VOC biopharmaceutical portfolios of innovative, largely patent-protected, in-line and newly launched products will be sustained by ongoing investments to develop promising assets and targeted business development in areas of focus to ensure a pipeline of highly-differentiated product candidates in areas of unmet medical need. The assets managed by these groups are science-driven, highly differentiated and generally require a high-level of engagement with healthcare providers and consumers.
GEP is expected to generate strong consistent cash flow by providing patients around the world with access to effective, lower-cost, high-value treatments. GEP leverages our biologic development, regulatory and manufacturing expertise to seek to advance its biosimilar development portfolio. Additionally, GEP leverages capabilities in formulation development and manufacturing expertise to help advance its generic sterile injectables portfolio. In addition, GEP may also engage in targeted business development to further enable its commercial strategies. GEP has the knowledge and resources within R&D to develop small molecules, including injectables, and biosimilars. On September 3, 2015, we acquired Hospira, and its commercial operations are now included within GEP. Commencing from the acquisition date, and in accordance with our domestic and international reporting periods, our consolidated statement of income, primarily GEP’s operating results, for the year ended December 31, 2015 reflect four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations. For additional information about the Hospira acquisition, see Notes to Consolidated Financial Statements––Note 2A. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions.
For additional information about our operating structure, see Notes to Consolidated Financial Statements––Note 18. Segment, Geographic and Other Revenue Information: Segment Information.

For additional information about the 2015 performance of each of our operating segments, see the “Analysis of Operating Segment Information” section of this Financial Review.
Following the closing of the pending combination with Allergan, the Vaccines and Oncology businesses are expected to be combined with the Global Innovative Pharmaceutical business and we expect to create a new global business, Global Specialty and Consumer Brands, that includes our Consumer Healthcare business and Allergan’s ophthalmology and aesthetics businesses, as well as Botox Therapeutic and Cosmetic. Allergan’s Anda distribution capabilities and brands in women’s health and anti-infectives are expected to be combined with the Global Established Pharmaceutical business.

8
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Research Operations
We continue to strengthen our global R&D organization and pursue strategies intended to improve innovation and overall productivity in R&D to achieve a sustainable pipeline that will deliver value in the near term and over time. Our R&D priorities include delivering a pipeline of differentiated therapies with the greatest scientific and commercial promise, innovating new capabilities that can position Pfizer for long-term leadership and creating new models for biomedical collaboration that will expedite the pace of innovation and productivity. To that end, our R&D primarily focuses on six high-priority areas that have a mix of small molecules and large molecules––immunology and inflammation; cardiovascular and metabolic diseases; oncology; vaccines; neuroscience and pain; and rare diseases. Another area of focus is biosimilars. With the acquisition of Hospira, we have expanded our biosimilars pipeline and added R&D capabilities for sterile injectables and infusion systems.
While a significant portion of R&D is done internally through the Worldwide Research and Development (WRD) organization, we continue to seek to enhance our pipeline of potential future products by entering into collaborations, alliance and license agreements with other companies, as well as leveraging acquisitions and equity- or debt-based investments. These agreements enable us to co-develop, license or acquire promising compounds, technologies or capabilities. Collaboration, alliance and license agreements and equity- or debt-based investments allow us to share risk and cost, to access external scientific and technological expertise, and enable us to advance our own products as well as in-licensed or acquired products.

For additional information about R&D by operating segment, see the “Analysis of Operating Segment Information” section of this Financial Review. For additional information about our pending new drug applications and supplemental filings, see the “Analysis of the Consolidated Statements of Income––Product Developments––Biopharmaceutical” section of this Financial Review. For additional information about recent transactions and strategic investments that we believe have the potential to advance our pipeline and maximize the value of our in-line products, see the “Our Business Development Initiatives” section of this Financial Review.
Business Development
We continue to build on our broad portfolio of businesses and to expand our R&D pipeline through various business development transactions. For additional information about recent transactions and strategic investments that we believe have the potential to advance our pipeline, enhance our product portfolio and maximize the value of our in-line products, see the “Our Business Development Initiatives” section of this Financial Review.
Intellectual Property Rights
We continue to aggressively defend our patent rights against increasingly aggressive infringement whenever appropriate, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to ensure appropriate patient access. In addition, we will continue to employ innovative approaches designed to prevent counterfeit pharmaceuticals from entering the supply chain and to achieve greater control over the distribution of our products, and we will continue to participate in the generics market for our products, whenever appropriate, once they lose exclusivity. For additional information about our current efforts to enforce our intellectual property rights, see Notes to Consolidated Financial Statements––Note 17A1. Commitments and Contingencies: Legal Proceedings––Patent Litigation. For information on risks related to patent protection and intellectual property claims by third parties, see "Risks Related to Intellectual Property" in Part I. Item 1A “Risk Factors” in our 2015 Annual Report on Form 10-K.
Capital Allocation and Expense Management
We seek to maintain a strong balance sheet and robust liquidity so that we continue to have the financial resources necessary to take advantage of prudent commercial, research and business development opportunities and to directly enhance shareholder value through share repurchases and dividends. For additional information about our financial condition, liquidity, capital resources, share repurchases and dividends, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this Financial Review.
On November 23, 2015, we announced that we have entered into a definitive merger agreement with Allergan, a global pharmaceutical company incorporated in Ireland, under which we have agreed to combine with Allergan in a stock transaction valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015 (the last trading day prior to the announcement) and certain other assumptions. See the “Our Business”, “Our Business Development Initiatives” and “Analysis of Financial Condition, Liquidity and Capital Resources” sections of this Financial Review for additional information.
On September 3, 2015, (the acquisition date), we acquired Hospira for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired). See Notes to Consolidated Financial Statements––Note 2A. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions and the “Significant Accounting Policies and Application of Critical Accounting Estimates––Acquisition of Hospira” section of this Financial Review for additional information.

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. In July 2015, we completed the agreement. For additional information, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this Financial Review and Notes to Consolidated Financial Statements––Note 12. Equity. In November 2015, we announced that, consistent with 2015, we expect to execute an approximately $5 billion accelerated share repurchase program in the first half of 2016. We anticipate additional future share repurchases to continue following the consummation of the pending combination with Allergan. The actual size and timing of any such share repurchases will depend on actual and expected financial results.
In December 2015, the Board of Directors authorized a new $11 billion share repurchase program to be utilized over time. Also, on December 14, 2015, our Board of Directors declared a first-quarter 2016 dividend of $0.30 per share, an increase from the $0.28 per-share

2015 Financial Report    
 
 
9


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

quarterly dividend paid during 2015. For additional information, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this Financial Review and Notes to Consolidated Financial Statements––Note 12. Equity.

We remain focused on achieving an appropriate cost structure for the Company. For additional information about our cost-reduction and productivity initiatives, see the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this Financial Review and Notes to Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.

Our Business Development Initiatives

We are committed to capitalizing on growth opportunities by advancing our own pipeline and maximizing the value of our in-line products, as well as through various forms of business development, which can include alliances, licenses, joint ventures, collaborations, equity- or debt-based investments, dispositions, mergers and acquisitions. We view our business development activity as an enabler of our strategies, and we seek to generate earnings growth and enhance shareholder value by pursuing a disciplined, strategic and financial approach to evaluating business development opportunities. We are especially interested in opportunities in our high-priority therapeutic areas—immunology and inflammation; cardiovascular and metabolic diseases; oncology; vaccines; neuroscience and pain; and rare diseases––and in emerging markets and established products, including biosimilars. We continue to evaluate business development transactions that have the potential to strengthen one or both of our businesses and their capabilities, such as our recent acquisition of Hospira and our pending combination with Allergan, as well as collaborations, and alliance and license agreements with other companies, including our collaborations with Cellectis SA, OPKO Health, Inc. and Merck KGaA. We assess our businesses, assets and scientific capabilities/portfolio as part of our regular, ongoing portfolio review process and also continue to consider business development activities that will advance our businesses. We are continuing to consider whether a further separation of our Innovative Products and Established Products businesses would be in the best interests of our shareholders. However, no decision has been made regarding any such potential separation; we anticipate making a decision regarding any such potential separation by no later than the end of 2018. For additional information on our business development activities, see Notes to Consolidated Financial Statements––Note 2. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment, Notes to Consolidated Financial Statements––Note 19. Pending Combination with Allergan and the “Significant Accounting Policies and Application of Critical Accounting Estimates––Acquisition of Hospira” section of this Financial Review.
The more significant recent transactions and events are described below:
Agreement to Combine with Allergan plc (Allergan)––On November 23, 2015, we announced that we have entered into a definitive merger agreement with Allergan, a global pharmaceutical company incorporated in Ireland.
Acquisition of Hospira––On September 3, 2015 (the acquisition date), we acquired Hospira, a leading provider of sterile injectable drugs and infusion technologies as well as a provider of biosimilars, for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired).
Acquisition of a Minority Interest in AM-Pharma B.V. (AM-Pharma)––In April 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 2017. 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.
Collaboration with OPKO Health, Inc. (OPKO)––In December 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 hormone deficiency (GHD) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by two years of age. hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. We have received the exclusive license to commercialize hGH-CTP worldwide. OPKO will lead the clinical activities and will be responsible for funding the development programs for the key indications, which include Adult and Pediatric GHD and Pediatric SGA. We will be responsible for all development costs for additional indications, all postmarketing studies, manufacturing and commercialization activities for all indications, and we will lead the manufacturing activities related to product development. The transaction closed on January 28, 2015, upon termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. In February 2015, we made an upfront payment of $295 million to OPKO, which was recorded in Research and development expenses, and OPKO is eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones. OPKO is also eligible to receive royalty payments associated with the commercialization of hGH-CTP for Adult GHD, which is subject to regulatory approval. Upon the launch of hGH-CTP for Pediatric GHD, which is subject to regulatory approval, the royalties will transition to tiered gross profit sharing for both hGH-CTP and our product, Genotropin.
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 acquired 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––In November 2014, we entered into a collaborative agreement with Merck KGaA, to jointly develop and commercialize avelumab, the proposed international non-proprietary name for the investigational anti-PD-L1 antibody (MSB0010718C), 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 collaboration with Merck KGaA has initiated 28 programs, monotherapy and combination trials, including seven pivotal trials in Phase IB/2 or Phase 3 (two in lung cancer, two in gastric cancer, and one in each of bladder cancer, Merkel cell carcinoma and ovarian cancer) and received FDA breakthrough therapy designation for avelumab in metastatic Merkel cell carcinoma. We and Merck KGaA are also combining resources and expertise to advance Pfizer’s anti-PD-1 antibody into

10
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

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, and co-promotion activities were initiated in key select markets in 2015. 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 consideration of up to $135 million.
License from Cellectis SA (Cellectis)––In June 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, in connection with this licensing agreement, we made an upfront payment of $80 million to Cellectis, which was recorded in Research and development expenses. We will also fund research and development 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.
Investment in ViiV Healthcare Limited (ViiV)––On January 21, 2014, the European Commission approved Tivicay (dolutegravir), a product for the treatment of HIV-1 infection, developed by ViiV, an equity-method investee. This approval, in accordance with the agreement between GlaxoSmithKline plc and Pfizer, triggered a reduction in our equity interest in ViiV from 12.6% to 11.7% and an increase in GlaxoSmithKline plc’s equity interest in ViiV from 77.4% to 78.3%, effective April 1, 2014. As a result, in 2014, we recognized a loss of approximately $30 million in Other (income)/deductions––net. We account for our investment in ViiV under the equity method due to the significant influence that we continue to have through our board representation and minority veto rights.
Collaboration with Eli Lilly & Company (Lilly)––In October 2013, we entered into a collaboration agreement with Lilly to jointly develop and globally commercialize Pfizers tanezumab, which provides that Pfizer and Lilly will equally share product-development expenses as well as potential revenues and certain product-related costs. Following the decision by the FDA in March 2015 to lift the partial clinical hold on the tanezumab development program, we received a $200 million upfront payment from Lilly in accordance with the collaboration agreement between Pfizer and Lilly, which is recorded as deferred revenue in our consolidated balance sheet and is being recognized into Other (income)/deductions––net over a multi-year period beginning in the second quarter of 2015. Pfizer and Lilly resumed the Phase 3 chronic pain program for tanezumab in July 2015, which will consist of six studies in approximately 7,000 patients across osteoarthritis, chronic low back pain and cancer pain. Under the collaboration agreement with Lilly, we are eligible to receive additional payments from Lilly upon the achievement of specified regulatory and commercial milestones.
Divestiture of Zoetis––On June 24, 2013, we completed the full disposition of Zoetis. The full disposition was completed through a series of steps, including, in the first quarter of 2013, the formation of Zoetis and an initial public offering (IPO) of an approximate 19.8% interest in Zoetis and, in the second quarter of 2013, an exchange offer for the remaining 80.2% interest.
Collaboration with Merck & Co., Inc. (Merck)––In April 2013, we announced that we entered into a worldwide (except Japan) collaboration agreement with Merck for the development and commercialization of Pfizer’s ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor currently in Phase 3 development for the treatment of type 2 diabetes.
Investment in Hisun Pfizer Pharmaceuticals Company Limited (Hisun Pfizer)––On September 6, 2012, we and Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun), a leading pharmaceutical company in China, formed a new company, Hisun Pfizer, to develop, manufacture, market and sell pharmaceutical products, primarily branded generic products, predominately in China. In the first quarter of 2013, we and Hisun contributed certain assets to Hisun Pfizer. Hisun Pfizer is 49% owned by Pfizer and 51% owned by Hisun. Our contributions constituted a business, as defined by U.S. GAAP, and in 2013, we recognized a pre-tax gain of approximately $459 million in Other (income)/deductions––net. In the third quarter of 2015, we determined that we had an other-than-temporary decline in value of our equity-method investment in Hisun Pfizer, and, therefore, in 2015, we recognized a loss of $463 million in Other (income)/deductions––net. The decline in value resulted from lower expectations as to the future cash flows to be generated by Hisun Pfizer, as a result of lower than expected recent performance, increased competition, a slowdown in the China economy in relation to their products, as well as changes in the regulatory environment.
License of Nexium OTC Rights––In August 2012, we entered into an agreement with AstraZeneca PLC (AstraZeneca) for the exclusive, global, over-the-counter (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 when incurred. 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. 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 and are being amortized over the estimated useful life of the Nexium brand. Included in Other current liabilities at December 31, 2015 are accrued milestone payments to AstraZeneca of $93 million. AstraZeneca is eligible to receive additional milestone payments of up to $200 million, based on the level of worldwide sales as well as quarterly royalty payments based on worldwide sales.


2015 Financial Report    
 
 
11


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Our Financial Guidance for 2016
The following table provides our financial guidance for full-year 2016(a), (b):
Reported revenues
$49.0 to $51.0 billion
Adjusted cost of sales as a percentage of reported revenues
21.0% to 22.0%
Adjusted selling, informational and administrative expenses
$13.2 to $14.2 billion
Adjusted research and development expenses
$7.3 to $7.8 billion
Adjusted other (income)/deductions
Approximately ($300 million) of income
Effective tax rate on adjusted income
Approximately 24.0%
Reported diluted Earnings per Share (EPS)
$1.54 to $1.67
Adjusted diluted EPS
$2.20 to $2.30
The following table provides a reconciliation of 2016 Adjusted income and Adjusted diluted EPS guidance to the 2016 Reported net income attributable to Pfizer Inc. and Reported diluted EPS attributable to Pfizer Inc. common shareholders guidance:
 
 
Full-Year 2016 Guidance(a), (b)
(BILLIONS OF DOLLARS, EXCEPT PER SHARE AMOUNTS)
 
Net Income
 
Diluted EPS
Adjusted income/diluted EPS guidance(b)
 
$13.6 - $14.2
 
$2.20 - $2.30
Purchase accounting impacts of transactions completed as of December 31, 2015
 
(2.8)
 
(0.46)
Restructuring, implementation and other acquisition-related costs
 
(0.7) - (0.9)
 
(0.11) - (0.14)
Business and legal entity alignment costs
 
(0.4)
 
(0.06)
Reported net income attributable to Pfizer Inc./diluted EPS guidance
 
$9.5 - $10.3
 
$1.54 - $1.67
(a) 
The 2016 financial guidance reflects the following:
Does not assume the completion of any business-development transactions not completed as of December 31, 2015, including any one-time upfront payments associated with such transactions. Our 2016 financial guidance excludes any impact from the pending combination with Allergan. The transaction is expected to close during the second half of 2016.
Excludes the potential effects of the resolution of litigation-related matters not substantially resolved as of February 12, 2016.
Exchange rates assumed are as of mid-January 2016.
Guidance for 2016 reported revenues reflects the anticipated negative impact of $2.3 billion due to recent and expected generic competition for certain products that have recently lost or are anticipated to soon lose patent protection.
Guidance for 2016 reported revenues also reflects the anticipated negative impact of $2.3 billion as a result of unfavorable changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2015, including $0.8 billion due to the estimated significant negative currency impact related to Venezuela. The anticipated negative impact on reported and adjusted diluted EPS resulting from unfavorable changes in foreign exchange rates compared to foreign exchange rates from 2015 is approximately $0.16, including $0.07 due to the estimated significant negative currency impact related to Venezuela.
Guidance for reported and adjusted diluted EPS assumes diluted weighted-average shares outstanding of approximately 6.2 billion shares.
(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 Financial Review.

For additional information about our actual and anticipated costs and cost savings associated with our cost-reduction initiatives announced in 2014, the Hospira acquisition, and our global commercial structure, which was established in 2014, see the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this Financial Review and Notes to Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.

Our 2016 financial guidance is subject to a number of factors and uncertainties—as described in the “Our Operating Environment”, “Our Strategy” and “Forward-Looking Information and Factors That May Affect Future Results” sections of this Financial Review and Part I, Item 1A, “Risk Factors,” of our 2015 Annual Report on Form 10-K.

SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS

For a description of our significant accounting policies, see Notes to Consolidated Financial Statements––Note 1. Basis of Presentation and Significant Accounting Policies. Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: (i) Acquisitions (Note 1D); (ii) Fair Value (Note 1E); (iii) Revenues (Note 1G); (iv) Asset Impairments (Note 1K); (v) Income Tax Contingencies (Note 1O); (vi) Pension and Postretirement Benefit Plans (Note 1P); and Legal and Environmental Contingencies (Note 1Q).

Following is a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements. See also Notes to Consolidated Financial Statements––Note 1C. Basis of Presentation and Significant Accounting Policies: Estimates and Assumptions for a discussion about the risks associated with estimates and assumptions.


12
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Acquisitions and Fair Value

For a discussion about the application of Fair Value to our recent acquisitions, see “Acquisition of Hospira” below and Notes to Consolidated Financial Statements—Note 2A. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions.

For a discussion about the application of Fair Value to our investments, see Notes to Consolidated Financial Statements—Note 7A. Financial Instruments: Selected Financial Assets and Liabilities.

For a discussion about the application of Fair Value to our benefit plan assets, see Notes to Consolidated Financial Statements––Note 11D. Pension and Postretirement Benefit Plans and Defined Contribution Plans: Plan Assets.

For a discussion about the application of Fair Value to our asset impairment reviews, see “Asset Impairment Reviews” below.

Revenues

Our gross product revenues are subject to a variety of deductions that are generally estimated and recorded in the same period that the revenues are recognized, and primarily represent rebates, chargebacks and sales allowances to government agencies, wholesalers/distributors and managed care organizations with respect to our pharmaceutical products. Those deductions represent estimates of rebates and discounts related to gross sales for the reporting period, and, as such, knowledge and judgment of market conditions and practice are required when estimating the impact of these revenue deductions on gross sales for a reporting period.

Historically, our adjustments of estimates, to reflect actual results or updated expectations, have not been material to our overall business. On a quarterly basis, our adjustments of estimates to reflect actual results generally have been less than 1% of revenues, and have resulted in either a net increase or a net decrease in revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product growth trends. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location. However, estimates associated with U.S. Medicare, Medicaid and performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year. Because of this time lag, in any given quarter, our adjustments to actual can incorporate revisions of several prior quarters.

Asset Impairment Reviews

We review all of our long-lived assets for impairment indicators throughout the year. We perform impairment testing for indefinite-lived intangible assets and goodwill at least annually and for all other long-lived assets whenever impairment indicators are present. When necessary, we record charges for impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets. Our impairment review processes are described in the Notes to Consolidated Financial Statements––Note 1K. Basis of Presentation and Significant Accounting Policies: Amortization of Intangible Assets, Depreciation and Certain Long-Lived Assets.

Examples of events or circumstances that may be indicative of impairment include:
A significant adverse change in legal factors or in the business climate that could affect the value of the asset. For example, a successful challenge of our patent rights would likely result in generic competition earlier than expected.
A significant adverse change in the extent or manner in which an asset is used. For example, restrictions imposed by the FDA or other regulatory authorities could affect our ability to manufacture or sell a product.
A projection or forecast that indicates losses or reduced profits associated with an asset. This could result, for example, from a change in a government reimbursement program that results in an inability to sustain projected product revenues and profitability. This also could result from the introduction of a competitor’s product that results in a significant loss of market share or the inability to achieve the previously projected revenue growth, as well as the lack of acceptance of a product by patients, physicians and payers. For in-process research and development (IPR&D) projects, this could result from, among other things, a change in outlook based on clinical trial data, a delay in the projected launch date or additional expenditures to commercialize the product.

Identifiable Intangible Assets

As a result of our identifiable intangible asset impairment review work, we recognized a number of impairments of identifiable intangible assets for the years ended December 31, 2015, 2014 and 2013. See Notes to Consolidated Financial Statements––Note 4. Other (Income)/DeductionsNet.

When we are required to determine the fair value of intangible assets other than goodwill, we use an income approach, specifically the discounted cash flow method. We start with a forecast of all the expected net cash flows associated with the asset, which includes the application of a terminal value for indefinite-lived assets, and then we apply an asset-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of competitive, legal and/or regulatory forces on the projections and the impact of technological risk associated with IPR&D assets, as well as the selection of a long-term growth rate; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows.

While all intangible assets other than goodwill can face events and circumstances that can lead to impairment, in general, intangible assets other than goodwill that are most at risk of impairment include IPR&D assets (approximately $1.2 billion as of December 31, 2015) and newly

2015 Financial Report    
 
 
13


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

acquired or recently impaired indefinite-lived brand assets (approximately $145 million as of December 31, 2015). IPR&D assets are high-risk assets, as research and development is an inherently risky activity. Newly acquired and recently impaired indefinite-lived assets are more vulnerable to impairment as the assets are recorded at fair value and are then subsequently measured at the lower of fair value or carrying value at the end of each reporting period. As such, immediately after acquisition or impairment, even small declines in the outlook for these assets can negatively impact our ability to recover the carrying value and can result in an impairment charge.

Goodwill

As a result of our goodwill impairment review work, we concluded that none of our goodwill was impaired as of December 31, 2015, and we do not believe the risk of impairment is significant at this time.

Fair value determinations require considerable judgment and are sensitive to changes in underlying assumptions and factors. Our Consumer Healthcare reporting unit has the narrowest difference between estimated fair value and estimated book value. A hypothetical decrease in the fair value of our Consumer Healthcare reporting unit of approximately 10% could trigger a potential impairment of its goodwill. Examples of events or circumstances that could impact the estimated fair value of a reporting unit may include items such as changes in operating results, anticipated future cash flows, the discount rate, market multiples, among others. Our Consumer Healthcare reporting unit performance and consumer healthcare industry market multiples are highly correlated with the overall economy and our specific performance is also dependent on our and our competitors’ innovation and marketing effectiveness, and on regulatory developments affecting claims, formulations and ingredients of our products. While historical performance and current expectations have resulted in fair values in excess of carrying values, if our assumptions are not realized, it is possible that in the future an impairment charge may need to be recorded. However, it is not possible at this time to determine if an impairment charge would result or if such a charge in the future would be material.

When we are required to determine the fair value of a reporting unit, as appropriate for the individual reporting unit, we mainly use the income approach but we may also use the market approach, or a weighted-average combination of both approaches.
The income approach is a forward-looking approach to estimating fair value and relies primarily on internal forecasts. Within the income approach, the method that we use is the discounted cash flow method. We start with a forecast of all the expected net cash flows associated with the reporting unit, which includes the application of a terminal value, and then we apply a reporting unit-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of technological risk and competitive, legal and/or regulatory forces on the projections, as well as the selection of a long-term growth rate; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows.
The market approach is a historical approach to estimating fair value and relies primarily on external information. Within the market approach are two methods that we may use:
Guideline public company method—this method employs market multiples derived from market prices of stocks of companies that are engaged in the same or similar lines of business and that are actively traded on a free and open market and the application of the identified multiples to the corresponding measure of our reporting unit’s financial performance.
Guideline transaction method—this method relies on pricing multiples derived from transactions of significant interests in companies engaged in the same or similar lines of business and the application of the identified multiples to the corresponding measure of our reporting unit’s financial performance.
The market approach is only appropriate when the available external information is robust and deemed to be a reliable proxy for the specific reporting unit being valued; however, these assessments may prove to be incomplete or inaccurate. Some of the more significant estimates and assumptions inherent in this approach include: the selection of appropriate guideline companies and transactions and the determination of applicable premiums and discounts based on any differences in ownership percentages, ownership rights, business ownership forms or marketability between the reporting unit and the guideline companies and transactions.
Specifically:
When we estimate the fair value of our four biopharmaceutical reporting units, we rely solely on the income approach. We use the income approach exclusively as the use of the comparable guideline company method is not practical or reliable. For the income approach, we use the discounted cash flow method.
When we estimate the fair value of our Consumer Healthcare reporting unit, we use a combination of approaches and methods. We use the income approach and the market approach, which we weight equally in our analysis. We weight them equally as we have equal confidence in the appropriateness of the approaches for this reporting unit. For the income approach, we use the discounted cash flow method and for the market approach, we use both the guideline public company method and the guideline transaction method, which we weight equally to arrive at our market approach value.
For all of our reporting units, there are a number of future events and factors that may impact future results and that could potentially have an impact on the outcome of subsequent goodwill impairment testing. For a list of these factors, see the “Forward-Looking Information and Factors That May Affect Future Results” section of this Financial Review and Part I. Item 1A “Risk Factors” in our 2015 Annual Report on Form 10-K.

Benefit Plans

The majority of our employees worldwide are covered by defined benefit pension plans, defined contribution plans or both. In the U.S., we have both Internal Revenue Code qualified and supplemental (non-qualified) defined benefit plans and defined contribution plans, as well as other postretirement benefit plans consisting primarily of medical insurance for retirees.


14
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

The accounting for benefit plans is highly dependent on actuarial estimates, assumptions and calculations, which can result from a complex series of judgments about future events and uncertainties. The assumptions and actuarial estimates required to estimate the employee benefit obligations for the defined benefit and postretirement plans include the discount rate; expected salary increases; certain employee-related factors, such as turnover, retirement age and mortality (life expectancy); expected return on assets; and healthcare cost trend rates.

In the fourth quarter of 2014, we approved a change, effective January 1, 2016, to the U.S. postretirement medical plan to transfer certain plan participants to a retiree drug coverage program eligible for a Medicare Part D plan subsidy (Employer Group Waiver Plan). This change resulted in a decrease to the postretirement benefit obligation of approximately $600 million as of December 31, 2014.

As of December 31, 2015, the noncurrent portion of our pension benefit obligations, net, and our postretirement benefit obligations, net decreased, in the aggregate, by approximately $2.1 billion compared to December 31, 2014. The decrease reflects, among other things, an increase in our discount rate assumptions used in the measurement of the plan obligations, a $1 billion voluntary contribution made in January, 2015, a plan amendment approved in June 2015 that introduced a cap on costs for certain groups within the U.S. postretirement medical plan, and a rise in the comparative strength of the U.S. dollar, as compared to other currencies.

Our assumptions reflect our historical experiences and our judgment regarding future expectations that have been deemed reasonable by management. The judgments made in determining the costs of our benefit plans can materially impact our results of operations.
The following table provides (i) at the end of each year, the expected annual rate of return on plan assets for the following year, (ii) the actual annual rate of return on plan assets achieved in each year, and (iii) the weighted-average discount rate used to measure the benefit obligations at the end of each year for our U.S. qualified pension plans and our international pension plans(a):
 
 
2015

 
2014

 
2013

U.S. Qualified Pension Plans
 
 
 
 
 
 
Expected annual rate of return on plan assets
 
8.0
 %
 
8.3
%
 
8.5
%
Actual annual rate of return on plan assets
 
(0.8
)
 
6.8

 
11.3

Discount rate used to measure the plan obligations
 
4.5

 
4.2

 
5.2

International Pension Plans
 
 
 
 
 
 
Expected annual rate of return on plan assets
 
5.2

 
5.5

 
5.8

Actual annual rate of return on plan assets
 
3.6

 
13.2

 
13.1

Discount rate used to measure the plan obligations
 
3.1

 
3.0

 
3.9

(a) 
For detailed assumptions associated with our benefit plans, see Notes to Consolidated Financial Statements—Note 11B. Pension and Postretirement Benefit Plans and Defined Contribution Plans: Actuarial Assumptions.
Expected Annual Rate of Return on Plan Assets

The assumptions for the expected annual rate of return on all of our plan assets reflect our actual historical return experience and our long-term assessment of forward-looking return expectations by asset classes, which is used to develop a weighted-average expected return based on the implementation of our targeted asset allocation in our respective plans.

The expected annual rate of return on plan assets for our U.S. plans and the majority of our international plans is applied to the fair value of plan assets at each year-end and the resulting amount is reflected in our net periodic benefit costs in the following year. In January 2016, Pfizer made a voluntary contribution of $1.0 billion to plan assets. In 2016, this contribution will be included in the plan asset balance for purposes of determining the expected return on plan assets.
The following table illustrates the sensitivity of net periodic benefit costs to a 50 basis point decline in our assumption for the expected annual rate of return on plan assets, holding all other assumptions constant (in millions, pre-tax):
 
 
Change
 
Increase in 2016 Net Periodic Benefit Costs
Assumption
 
 
 
 
Expected annual rate of return on plan assets
 
50 basis point decline
 
$98

The actual return on plan assets resulted in a net gain on our plan assets of approximately $163 million during 2015.

Discount Rate Used to Measure Plan Obligations

The weighted-average discount rate used to measure the plan obligations for our U.S. defined benefit plans is determined at least annually and evaluated and modified, as required, to reflect the prevailing market rate of a portfolio of high-quality fixed income investments, rated AA/Aa or better, that reflect the rates at which the pension benefits could be effectively settled. The discount rate used to measure the plan obligations for our international plans is determined at least annually by reference to investment grade corporate bonds, rated AA/Aa or better, including, when there are sufficient data, a yield-curve approach. These discount rate determinations are made in consideration of local requirements.

The measurement of the plan obligations at the end of the year will affect the amount of service cost, interest cost and amortization expense reflected in our net periodic benefit costs in the following year.

2015 Financial Report    
 
 
15


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

The following table illustrates the sensitivity of net periodic benefit costs and benefit obligations to a 10 basis point decline in our assumption for the discount rate, holding all other assumptions constant (in millions, pre-tax):
 
 
Change
 
2016 Net Periodic Benefit Costs
 
2015 Benefit Obligations
Assumption
 
 
 
Increase
 
Increase
Discount rate
 
10 basis point decline
 
$34
 
$411

The change in the discount rates used in measuring our plan obligations as of December 31, 2015 resulted in a decrease in the measurement of our aggregate plan obligations by approximately $1.0 billion.
Contingencies

For a discussion about income tax contingencies, see Notes to Consolidated Financial Statements—Note 5D. Tax Matters: Tax Contingencies.

For a discussion about legal and environmental contingencies, guarantees and indemnifications, see Notes to Consolidated Financial Statements—Note 17. Commitments and Contingencies
Acquisition of Hospira
Description of Transaction
On September 3, 2015 (the acquisition date), we acquired Hospira, a leading provider of sterile injectable drugs and infusion technologies as well as a provider of biosimilars, for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired).
Recording of Assets Acquired and Liabilities Assumed
Our acquisition of Hospira has been accounted for using the acquisition method of accounting, which generally requires that most assets acquired and liabilities assumed be recorded at fair value as of the acquisition date. A single estimate of fair value results from a complex series of judgments about future events and uncertainties and relies heavily on estimates and assumptions. Our judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact our results of operations. For instance, the determination of asset lives can impact our results of operations as different types of assets will have different useful lives and certain assets may even be considered to have indefinite useful lives.
For the provisional amounts recognized for the Hospira assets acquired and liabilities assumed as of the acquisition date, see Notes to Consolidated Financial Statements––Note 2A. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions. The estimated values are not yet finalized and are subject to change, which could be significant. We will finalize the amounts recognized as we obtain the information necessary to complete the analyses. We expect to finalize the amounts of assets acquired and liabilities assumed as soon as possible but no later than one year from the acquisition date. The following amounts are subject to change:
Amounts for certain balances included in working capital (excluding inventories), certain investments and certain legal contingencies, pending receipt of certain information that could affect provisional amounts recorded. We do not believe any adjustments for legal contingencies will have a material impact on our consolidated financial statements.
Amounts for intangibles, inventory and property, plant and equipment, pending finalization of valuation efforts for acquired intangible assets as well as the completion of certain physical inventory counts and the confirmation of the physical existence and condition of certain property, plant and equipment assets.
Amounts for income tax assets, receivables and liabilities, pending the filing of Hospira pre-acquisition tax returns and the receipt of information including but not limited to that from taxing authorities, which may change certain estimates and assumptions used.
Below is a summary of the methodologies and significant assumptions used in estimating the fair value of certain classes of assets and liabilities of Hospira.
For financial instruments acquired from Hospira, our valuation approach was consistent with our valuation methodologies used for our legacy Pfizer financial instruments. For additional information on the valuation of our financial instruments, see Notes to Consolidated Financial Statements—Note 7. Financial Instruments.
Inventories—The fair value of acquired inventory ($1.9 billion) was determined as follows:
Finished goods—Estimated selling price, less an estimate of costs to be incurred to sell the inventory, and an estimate of a reasonable profit allowance for that selling effort.
Work in process—Estimated selling price of an equivalent finished good, less an estimate of costs to be incurred to complete the work-in-process inventory, an estimate of costs to be incurred to sell the inventory and an estimate of a reasonable profit allowance for those manufacturing and selling efforts.
Raw materials and supplies—Estimated cost to replace the raw materials and supplies.
The fair value of inventory will be recognized in our results of operations as the inventory is sold. Based on internal forecasts and estimates of months of inventory on hand, we expect that the acquisition date inventory will be substantially sold and recognized in Cost of sales over a weighted-average estimated period of approximately eight months after the acquisition date.

16
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Some of the more significant estimates and assumptions inherent in the estimate of the fair value of inventory include stage of completion, costs to complete, costs to dispose and selling price. All of these judgments and estimates can materially impact our results of operations.
Property, Plant and Equipment—The fair value of acquired property, plant and equipment is determined using a variety of valuation approaches, depending on the nature of the asset and the quality of available information. The fair value of acquired property, plant and equipment was primarily determined as follows:
Land––Market, a sales comparison approach that measures value of an asset through an analysis of sales and offerings of comparable property.
Buildings, Machinery and equipment and Furniture and fixtures—Replacement cost, an approach that measures the value of an asset by estimating the cost to acquire or construct comparable assets. For buildings that are not highly specialized or that could be income producing if leased to a third party, we also considered market and income factors.
Construction in progress—Replacement cost, generally assumed to equal historical book value.
The amounts recorded for the major components of acquired property, plant and equipment are as follows:
(MILLIONS OF DOLLARS)
 
Useful Lives
(Years)
 
Amounts Recognized
As of Acquisition Date

Land
 
 
 
$
111

Buildings
 
33—50
 
556

Machinery and equipment
 
8—20
 
1,060

Furniture, fixtures and other
 
3—121/2
 
141

Construction in progress
 
 
 
542

Total Property, plant and equipment
 
 
 
$
2,410

The fair value of property, plant and equipment will be recognized in our results of operations over the expected useful life of the individual depreciable assets.
Some of the more significant inputs, estimates and assumptions inherent in the estimate of the fair value of property, plant and equipment include the nature, age, condition or location of the land, buildings, machinery and equipment, furniture and fixtures, and construction in progress, as applicable, as well as the estimate of market and replacement cost and the determination of the appropriate valuation premise, in-use or in-exchange. The in-use valuation premise assesses the value of an asset when used in combination with other assets (for example, on an installed basis), while the in-exchange valuation assesses the value of an asset on a stand alone basis. All of these judgments and estimates can materially impact our results of operations.
Identifiable Intangible AssetsThe fair value of acquired identifiable intangible assets generally is determined using an income approach. This method starts with a forecast of all of the expected future net cash flows associated with the asset and then adjusts the forecast to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.
The fair value of acquired identifiable intangible assets is composed of finite-lived developed technology rights with a weighted-average life of approximately 17 years ($7.7 billion); other finite-lived identifiable intangible assets with a weighted-average life of approximately 12 years ($550 million); and IPR&D assets ($995 million). For information about our identifiable intangible assets, see Notes to Consolidated Financial Statements––Note 10. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.
As of the acquisition date, we recognized IPR&D assets of $660 million for biosimilar programs and $335 million for sterile injectable programs.
Biosimilar IPR&D Acquired Assets:
In order to eliminate certain redundancies in Pfizer’s biosimilar drug products pipeline created as a result of the acquisition of Hospira, in September 2015 we opted to return to Celltrion Inc. and Celltrion Healthcare, Co., Ltd. (collectively Celltrion) rights that Hospira had previously acquired to potential biosimilars to Rituxan® (rituximab) and Herceptin® (trastuzumab). In connection with the return of these rights, we wrote-off these IPR&D assets, totaling $170 million. See the “Product Developments—Biopharmaceutical” section of this Financial Review and Notes to Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives for additional information.
The higher value remaining biosimilar IPR&D assets acquired from Hospira have been submitted to the FDA for approval and include the following potential biosimilars for (i) epoetin alfa (treatment of anemia in dialysis and oncology applications) and (ii) infliximab (rheumatoid arthritis and gastrointestinal disorders). These biosimilars and filgrastim (oncology) are already available in certain markets outside the U.S. Filgrastim in the U.S. market and other biosimilar IPR&D assets acquired from Hospira are in late-stage development. See the “Product Developments––Biopharmaceutical” section of this Financial Review for additional information about these programs.
Sterile Injectable IPR&D Acquired Assets:
The sterile injectable IPR&D assets acquired from Hospira are in various therapeutic areas including anti-infectives, oncology, cardiovascular and neurology, among others. The sterile injectable IPR&D assets are in various stages of development with anticipated launch dates across 2016, 2017 and 2018.
The fair value of finite-lived identifiable intangible assets will be recognized in our results of operations over the expected useful life of the individual assets.

2015 Financial Report    
 
 
17


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Some of the more significant estimates and assumptions inherent in the estimate of the fair value of identifiable intangible assets include all assumptions associated with forecasting product profitability from the perspective of a market participant.
Specifically:
Revenue—We use historical, forecast, industry or other sources of market data including estimates of sales volume, selling prices, market penetration, market share and year-over-year growth rates over the product’s life cycle.
Cost of sales, Sales and marketing expenses, General and administrative expenses—We use historical, forecast, industry or other sources of market data to estimate the costs associated with the identifiable intangible asset over the product’s life cycle.
R&D expenses—In the case of approved products, we estimate the appropriate level of ongoing R&D support, and for unapproved compounds, we estimate the amount and timing of costs to develop the R&D into viable products.
Estimated life of the asset—We assess the asset’s life cycle and the competitive trends impacting the asset, including consideration of any technical, legal, regulatory or economic barriers to entry, expected changes in standards of practice for indications addressed by the asset, as well as obsolescence factors and estimated contract renewal rates.
Inherent risk—We use a discount rate that is primarily based on the weighted-average cost of capital with an additional premium to reflect the risks associated with the specific intangible asset, such as country risks (political, inflation, currency and property risks) and commercial risks. In addition, for unapproved assets, an additional risk factor is added for the risk of technical and regulatory success, called the probability of technical and regulatory success (PTRS).
The discount rates used in the intangible asset valuations ranged from 11% to 16%, and the estimated cash flows were projected over periods extending up to 20 years or more. For IPR&D assets, the PTRS rates ranged from 44% to 88%. Within this broad range, we recorded approximately $20 million of assets with a PTRS of 44%, $220 million of assets with a PTRS of 45% to 75% and $755 million of assets with a PTRS above 75% ($585 million after the write-off of the acquired biosimilar IPR&D assets discussed above). All of these judgments and estimates can materially impact our results of operations.
For IPR&D assets, the risk of failure has been factored into the fair value measure and there can be no certainty that these assets ultimately will yield a successful product.
Contingencies—For acquisition date contingencies, see Notes to Consolidated Financial Statements––Note 2. Acquisitions, Licensing Agreements, Collaborative Arrangements, Divestitures, Equity-Method Investments and Cost-Method Investment: Acquisitions.


18
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

ANALYSIS OF THE CONSOLIDATED STATEMENTS OF INCOME
  
 
Year Ended December 31,
 
% Change
(MILLIONS OF DOLLARS)
 
2015
 
2014
 
2013
 
15/14
 
14/13
Revenues
 
$
48,851

 
$
49,605

 
$
51,584

 
(2
)
 
(4
)
Cost of sales
 
9,648

 
9,577

 
9,586

 
1

 

% of revenues
 
19.7
%
 
19.3
%
 
18.6
%
 
 
 
 
Selling, informational and administrative expenses
 
14,809

 
14,097

 
14,355

 
5

 
(2
)
% of revenues
 
30.3
%
 
28.4
%
 
27.8
%
 
 
 
 
Research and development expenses
 
7,690

 
8,393

 
6,678

 
(8
)
 
26

% of revenues
 
15.7
%
 
16.9
%
 
12.9
%
 
 
 
 
Amortization of intangible assets
 
3,728

 
4,039

 
4,599

 
(8
)
 
(12
)
% of revenues
 
7.6
%
 
8.1
%
 
8.9
%
 
 
 
 
Restructuring charges and certain acquisition-related costs
 
1,152

 
250

 
1,182

 
*

 
(79
)
% of revenues
 
2.4
%
 
0.5
%
 
2.3
%
 
 
 
 
Other (income)/deductions—net
 
2,860

 
1,009

 
(532
)
 
*

 
*

Income from continuing operations before provision for taxes on income
 
8,965

 
12,240

 
15,716

 
(27
)
 
(22
)
% of revenues
 
18.4
%
 
24.7
%
 
30.5
%
 
 
 
 
Provision for taxes on income
 
1,990

 
3,120

 
4,306

 
(36
)
 
(28
)
Effective tax rate
 
22.2
%
 
25.5
%
 
27.4
%
 
 
 
 
Income from continuing operations
 
6,975

 
9,119

 
11,410

 
(24
)
 
(20
)
% of revenues
 
14.3
%
 
18.4
%
 
22.1
%
 
 
 
 
Discontinued operations—net of tax
 
11

 
48

 
10,662

 
(77
)
 
*

Net income before allocation to noncontrolling interests
 
6,986

 
9,168

 
22,072

 
(24
)
 
(58
)
% of revenues
 
14.3
%
 
18.5
%
 
42.8
%
 
 
 
 
Less: Net income attributable to noncontrolling interests
 
26

 
32

 
69

 
(21
)
 
(53
)
Net income attributable to Pfizer Inc.
 
$
6,960

 
$
9,135

 
$
22,003

 
(24
)
 
(58
)
% of revenues
 
14.2
%
 
18.4
%
 
42.7
%
 
 
 
 
Certain amounts and percentages may reflect rounding adjustments.
*
Calculation not meaningful.
Revenues—Overview

Total revenues were $48.9 billion in 2015, a decrease of 2% compared to 2014, which reflects an operational increase of $3.0 billion, or 6%, more than offset by the unfavorable impact of foreign exchange of $3.8 billion, or 8%, in 2015 compared to 2014. The operational increase was primarily the result of:
the performance of several key products in developed markets, including the continued strong uptake of Prevnar 13 among adults (largely in the U.S.), Ibrance (nearly all in the U.S.), Eliquis, Lyrica (GIP) (primarily in the U.S. and Japan), Xeljanz (primarily in the U.S.), Viagra (GIP) (primarily in the U.S.) and Nexium 24HR (primarily in the U.S.) (collectively, up approximately $4.1 billion);
inclusion of legacy Hospira operations of $1.5 billion;
a 7% operational increase in revenues in emerging markets, reflecting continued strong operational growth, primarily from Prevenar 13, Lipitor and Enbrel (up approximately $810 million); and
inclusion of the vaccines acquired from Baxter of $178 million,
partially offset by:
the loss of exclusivity and immediate multi-source generic competition for Celebrex in the U.S. in December 2014 and certain other developed markets (down approximately $1.8 billion), and the loss of exclusivity for Lyrica (GEP) in certain developed Europe markets (down approximately $420 million), for Zyvox in the U.S. (down approximately $420 million), for Rapamune in the U.S. (down approximately $120 million) and for certain other products (collectively, down approximately $530 million);
the performance of certain other products in developed markets and BeneFIX in the U.S. (collectively, down approximately $370 million); and
the termination of the Spiriva co-promotion collaboration in certain countries (down approximately $100 million).
Total revenues were $49.6 billion in 2014, a decrease of 4% compared to 2013, which reflects an operational decrease of $1.1 billion, or 2%, and the unfavorable impact of foreign exchange of approximately $912 million, or 2%, in 2014 compared to 2013. The operational decrease was primarily the result of:
the expiration of the co-promotion term of the collaboration agreement for Enbrel in the U.S. and Canada (approximately $1.4 billion);

2015 Financial Report    
 
 
19


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

the loss of exclusivity and subsequent multi-source generic competition for Detrol LA, Celebrex and Geodon in the U.S., Viagra in most major European markets, and Aricept and Lyrica in Canada (aggregate decline of approximately $937 million) and certain other products(approximately $300 million);
the continued erosion of branded Lipitor in the U.S. and most other developed markets due to generic competition and the operational decline of certain products, including Norvasc, Effexor, atorvastatin, Metaxalone, Zosyn/Tazocin, Ziprasidone, Genotropin, Tygacil, Centrum, Advil and Vfend (approximately $938 million); and
the ongoing termination of the Spiriva collaboration in certain countries (approximately $490 million),
partially offset by:
the operational growth of certain products in certain developed markets, including Lyrica, Prevnar, Eliquis, Xeljanz, Xalkori, Inlyta and Nexium 24HR in the U.S. as a result of its May 2014 launch, among others (approximately $1.8 billion); and
a 7% operational increase in revenues in emerging markets (approximately $900 million), including strong operational growth from Prevenar as well as from Lipitor, primarily in China, and from Enbrel, primarily in Latin America.

See the “Intellectual Property Rights and Collaboration/Licensing Rights” section of this Financial Report for information about (i) recent losses of product exclusivity impacting product revenues, (ii) recent and expected losses of collaboration rights impacting alliance revenues and (iii) losses and expected losses of product exclusivity in 2016.

In addition, we expect to lose exclusivity for various other products in various markets over the next few years. For additional information, see the “Patents and Other Intellectual Property Rights” section in Part I, Item 1, “Business”, of our 2015 Annual Report on Form 10-K.

We have significant operations outside the U.S., with revenues exceeding $500 million in the following number of countries:
The U.S. and Japan are our two largest national markets:

Revenues by Market

Our policy relating to the supply of pharmaceutical inventory at domestic wholesalers, and in major international markets, is to generally maintain stocking levels under one month on average and to keep monthly levels consistent from year to year based on patterns of utilization. We historically have been able to closely monitor these customer stocking levels by purchasing information from our customers directly or by obtaining other third-party information. We believe our data sources to be directionally reliable but cannot verify their accuracy. Further, as we do not control this third-party data, we cannot be assured of continuing access. Unusual buying patterns and utilization are promptly investigated.

Revenue Deductions

Our gross product revenues are subject to a variety of deductions that are generally estimated and recorded in the same period that the revenues are recognized, and primarily represent rebates, chargebacks and sales allowances to government agencies, wholesalers/distributors and managed care organizations with respect to our pharmaceutical products. Those deductions represent estimates of rebates and discounts related to gross sales for the reporting period and, as such, knowledge and judgment of market conditions and practice are required when estimating the impact of these revenue deductions on gross sales for a reporting period.

Historically, our adjustments of estimates, to reflect actual results or updated expectations, have not been material to our overall business. On a quarterly basis, our adjustments of estimates to reflect actual results generally have been less than 1% of revenues, and have resulted in either a net increase or a net decrease in revenues. Product-specific rebates, however, can have a significant impact on year-over-year

20
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

individual product growth trends. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location. However, estimates associated with U.S. Medicare, Medicaid and performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year. Because of this time lag, in any given quarter, our adjustments to actual can incorporate revisions of several prior quarters.
The following table provides information about deductions from revenues:
  
 
Year Ended December 31,
(MILLIONS OF DOLLARS)
 
2015

 
2014

 
2013

Medicare rebates(a)
 
$
1,002

 
$
1,077

 
$
887

Medicaid and related state program rebates(a)
 
1,263

 
779

 
508

Performance-based contract rebates(a), (b)
 
2,253

 
2,219

 
2,117

Chargebacks(c)
 
4,961

 
3,755

 
3,569

Sales allowances(d)
 
4,200

 
4,547

 
4,395

Sales returns and cash discounts
 
1,335

 
1,279

 
1,225

Total(e)
 
$
15,014

 
$
13,656

 
$
12,701

(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 2015, associated with the following segments: GIP ($4.3 billion); VOC ($1.5 billion); and GEP ($9.1 billion). For 2014, associated with the following segments: GIP ($3.3 billion); VOC ($1.2 billion); and GEP ($9.1 billion). For 2013, associated with the following segments: GIP ($2.8 billion); VOC ($1.0 billion); and GEP ($8.9 billion).

The total deductions from revenues for 2015 increased 10% compared to 2014, primarily as a result of:
an increase in chargebacks from certain Innovative Business products, GEP products including products that have lost exclusivity in the U.S. during 2015, as well as the addition in 2015 of Hospira sterile injectables, which are subject to chargebacks; and
an increase in Medicaid and related state program rebates, primarily as a result of updated estimates of sales related to these programs, and, a decrease in Managed Medicaid estimated rebates in the second quarter of 2014,
partially offset by:
a decrease in sales allowances primarily in Asia and Europe. In Asia, the decrease is due to lower Lipitor sales and the end of a partnership arrangement for Caduet. In Europe, price declines primarily on GEP products were driven by government decrees that progressively reduce pricing on products that have lost exclusivity.

For additional rebate accrual information, see Notes to Consolidated Financial Statements––Note 1G. Basis of Presentation and Significant Accounting Policies: Revenues and Trade Accounts Receivable.

Our accruals for Medicare rebates, Medicaid and related state program rebates, performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts totaled $3.9 billion as of December 31, 2015, of which approximately $2.6 billion is included in Other current liabilities, $272 million is included in Other noncurrent liabilities and approximately $1.1 billion is included against Trade accounts receivable, less allowance for doubtful accounts, in our consolidated balance sheet. Our accruals for Medicare rebates, Medicaid and related state program rebates, performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts totaled $3.4 billion as of December 31, 2014, of which approximately $2.0 billion is included in Other current liabilities, $300 million is included in Other noncurrent liabilities and approximately $1.1 billion is included against Trade accounts receivable, less allowance for doubtful accounts, in our consolidated balance sheet. Total accruals for Medicare rebates, Medicaid and related state program rebates, performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts as of December 31, 2015 increased by approximately $500 million compared to December 31, 2014, primarily due to the addition of Hospira accruals.


2015 Financial Report    
 
 
21


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Revenues by Segment and Geographic Area
The following table provides worldwide revenues by operating segment and geographic area:
 
 
Year Ended December 31,
 
% Change
 
 
Worldwide
 
U.S.
 
International
 
Worldwide
 
U.S.
 
International
(MILLIONS OF DOLLARS)
 
2015

 
2014

 
2013

 
2015

 
2014

 
2013

 
2015

 
2014

 
2013

 
15/14

 
14/13

 
15/14

 
14/13

 
15/14

 
14/13

Operating Segments(a):
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GIP
 
$
13,954

 
$
13,861

 
$
14,317

 
$
6,946

 
$
6,243

 
$
6,810

 
$
7,008

 
$
7,619

 
$
7,507

 
1

 
(3
)
 
11

 
(8
)
 
(8
)
 
1

VOC
 
12,803

 
10,144

 
9,285

 
7,500

 
4,715

 
4,122

 
5,303

 
5,428

 
5,163

 
26

 
9

 
59

 
14

 
(2
)
 
5

GEP
 
21,587

 
25,149

 
27,619

 
7,030

 
7,903

 
9,217

 
14,557

 
17,245

 
18,400

 
(14
)
 
(9
)
 
(11
)
 
(14
)
 
(16
)
 
(6
)
 
 
48,345

 
49,154

 
51,221

 
21,476

 
18,861

 
20,149

 
26,868

 
30,292

 
31,070

 
(2
)
 
(4
)
 
14

 
(6
)
 
(11
)
 
(3
)
Other(b)
 
506

 
451

 
364

 
228

 
212

 
124

 
279

 
239

 
240

 
12

 
24

 
7

 
71

 
17

 

Total revenues
 
$
48,851

 
$
49,605

 
$
51,584

 
$
21,704

 
$
19,073

 
$
20,274

 
$
27,147

 
$
30,532

 
$
31,310

 
(2
)
 
(4
)
 
14

 
(6
)
 
(11
)
 
(2
)
(a) 
GIP = the Global Innovative Pharmaceutical segment; VOC = the Global Vaccines, Oncology and Consumer Healthcare segment; and GEP = the Global Established Pharmaceutical segment. On September 3, 2015, we acquired Hospira and its commercial operations are now included within GEP. Commencing from the acquisition date, and in accordance with our domestic and international reporting periods, our consolidated statement of income, primarily GEP’s operating results, for the year ended December 31, 2015 reflects four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations.
(b) 
Includes revenues generated from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and also includes the revenues related to our manufacturing and supply agreements with Zoetis Inc. (Zoetis).
Revenues

We recorded direct product sales of more than $1 billion for each of seven products in 2015, and for each of ten products in 2014 and 2013. We recorded more than $1 billion in Alliance revenues in 2015 (primarily Eliquis) and 2013. These direct product sales and alliance revenues represent 44% of our revenues in 2015, 52% of our revenues in 2014 and 52% of our revenues in 2013. See the Revenues—Major Products section of this Financial Review for additional information.

2015 v. 2014

See the RevenuesOverview section of this Analysis of the Consolidated Statements of Income for a discussion of performance of worldwide revenues.

Geographically,
in the U.S., revenues increased $2.6 billion, or 14%, in 2015, compared to 2014, reflecting, among other things:
the performance of several key products, including Prevnar 13 primarily in adults (up approximately $1.9 billion), Ibrance (which was launched in the U.S. in February 2015, up approximately $720 million), as well as Lyrica (GIP), Eliquis, Xeljanz, Viagra (GIP) and Nexium 24HR (collectively, up approximately $1.0 billion in 2015), and
the inclusion of four months of legacy Hospira U.S. operations of $1.2 billion in 2015,
partially offset by:
losses of exclusivity and associated multi-source generic competition for Celebrex in the U.S. in December 2014 (down approximately $1.6 billion in 2015);
the loss of exclusivity for Zyvox and Rapamune, as well as the termination of our Spiriva co-promotion collaboration (collectively, down approximately $620 million in 2015); and
the performance of Lipitor and BeneFIX (collectively, down approximately $160 million in 2015).
in our international markets, revenues decreased $3.4 billion, or 11%, in 2015, compared to 2014. Foreign exchange unfavorably impacted international revenues by approximately $3.8 billion, or 12% in 2015. Operationally, revenues increased by $402 million or 1%, in 2015 compared to 2014 reflecting, among other things:
the operational increase in revenues in emerging markets, reflecting continued strong operational growth primarily from the Innovative Products business, including Prevenar and Enbrel, among other products, and Lipitor (up approximately $600 million in 2015);
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 $590 million in 2015); and
the inclusion of three months of legacy Hospira international operations of $270 million in 2015,
partially offset by:
lower revenues in developed markets for Lyrica (GEP), Celebrex, Inspra and Viagra (GEP) as a result of the loss of exclusivity, as well as the performance of Lipitor and Norvasc in developed markets, and Zosyn/Tazocin in emerging markets (collectively, down approximately $1.0 billion in 2015).
In 2015, international revenues represented 56% of total revenues, compared to 62% in 2014. Excluding foreign exchange, international revenues in 2015 represented 59% of total revenues, compared to 62% in 2014.


22
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

2014 v. 2013

See the RevenuesOverview section of this Analysis of the Consolidated Statements of Income for a discussion of performance of worldwide revenues.

Geographically,
in the U.S., revenues decreased $1.2 billion or 6% in 2014, compared to 2013, reflecting, among other things:
lower Alliance revenues, primarily due to Enbrel, reflecting the expiration of the co-promotion term of the collaboration agreement in October 2013 (down approximately $1.3 billion in 2014), and Spiriva, reflecting the final-year terms, and termination on April 29, 2014, of the co-promotion collaboration, which, per the terms of the collaboration agreement, resulted in a decline of our share of Spiriva revenue (down approximately $395 million in 2014); and
lower revenues from Detrol LA due to loss of exclusivity (down approximately $321 million in 2014), Celebrex due to loss of exclusivity in December 2014 (down approximately $198 million), and lower revenues from Lipitor (down approximately $191 million in 2014),
partially offset by:
the strong performance of Lyrica (up approximately $352 million in 2014) as well as the growth of Prevnar, Xeljanz, Eliquis, Xalkori and Inlyta (collectively, up approximately $760 million in 2014).
in our international markets, revenues decreased $778 million, or 2%, in 2014, compared to 2013, primarily due to the unfavorable impact of foreign exchange of approximately $912 million in 2014, or 3%. Operationally, revenues increased slightly by $134 million, in 2014 compared to 2013 reflecting, among other things:
higher operational revenues for Lipitor in China, Lyrica in developed markets, Enbrel outside Canada, and the performance of recently launched products Eliquis, Xalkori, and Inlyta (collectively, up approximately $941 million in 2014); and
the operational growth of Prevenar and Xeljanz (collectively, up approximately $228 million in 2014),
partially offset by:
the operational decline of certain products, including Norvasc, Zithromax, Xalabrands, Detrol, Effexor and Chantix/Champix, in developed international markets, and Sutent in China (collectively, down approximately $320 million in 2014);
lower revenues as a result of the loss of exclusivity and subsequent multi-source generic competition for Viagra in most major European markets and Lyrica in Canada (collectively, down approximately $248 million in 2014);
lower Alliance revenues (down approximately $218 million in 2014, excluding Eliquis), primarily due to the expiration of the co-promotion term of the collaboration agreement for Enbrel in Canada, the ongoing termination of the Spiriva collaboration agreement in certain countries, the loss of exclusivity for Aricept in Canada and the termination of the co-promotion agreement for Aricept in Japan in December 2012; and
the continued erosion of branded Lipitor in most international developed markets (down approximately $197 million in 2014).
In 2014, international revenues represented 62% of total revenues, compared to 61% in 2013. Excluding foreign exchange, international revenues in 2014 represented 62% of total revenues, compared to 62% in 2013.

For additional information about operating segment revenues, see the “Analysis of Operating Segment Information” section of this Financial Review.

2015 Financial Report    
 
 
23


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

Revenues—Major Products
The following table provides revenue information for several of our major products:
(MILLIONS OF DOLLARS)
 
 
 
Year Ended December 31,
 
% Change
PRODUCT
PRIMARY INDICATIONS
 
2015

 
2014

 
2013

 
15/14
 
14/13
INNOVATIVE PRODUCTS BUSINESS(a)
 
$
26,758

 
$
24,005

 
$
23,602

 
11

 
2

GIP(a)
 
$
13,954

 
$
13,861

 
$
14,317

 
1

 
(3
)
Lyrica GIP(b)
 
Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia and neuropathic pain due to spinal cord injury
 
3,655

 
3,350

 
2,965

 
9

 
13

Enbrel (Outside the U.S. and Canada)
 
Rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis
 
3,333

 
3,850

 
3,774

 
(13
)
 
2

Viagra GIP(c)
 
Erectile dysfunction
 
1,297

 
1,181

 
1,180

 
10

 

BeneFIX
 
Hemophilia
 
752

 
856

 
832

 
(12
)
 
3

Chantix/Champix
 
An aid to smoking cessation treatment
 
671

 
647

 
648

 
4

 

Genotropin
 
Replacement of human growth hormone
 
617

 
723

 
772

 
(15
)
 
(6
)
Refacto AF/Xyntha
 
Hemophilia
 
533

 
631

 
602

 
(16
)
 
5

Xeljanz
 
Rheumatoid arthritis
 
523

 
308

 
114

 
70

 
*

Toviaz
 
Overactive bladder
 
267

 
288

 
236

 
(7
)
 
22

BMP2
 
Development of bone and cartilage
 
232

 
228

 
209

 
2

 
9

Somavert
 
Acromegaly
 
218

 
229

 
217

 
(5
)
 
6

Rapamune
 
Prevention of organ rejection in kidney transplantation
 
197

 
339

 
350

 
(42
)
 
(3
)
Alliance revenue GIP(d), (o)
 
Various
 
1,254

 
762

 
1,878

 
65

 
(59
)
All other GIP(e)
 
Various
 
405

 
469

 
540

 
(14
)
 
(13
)
VOC(a)
 
$
12,803

 
$
10,144

 
$
9,285

 
26

 
9

Prevnar family(f)
 
Vaccines for prevention of pneumococcal disease
 
6,245

 
4,464

 
3,974

 
40

 
12

Sutent
 
Advanced and/or metastatic renal cell carcinoma (mRCC), refractory gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumor
 
1,120

 
1,174

 
1,204

 
(5
)
 
(2
)
Ibrance
 
Advanced breast cancer
 
723

 

 

 
*

 

Xalkori
 
Anaplastic lymphoma kinase positive non-small cell lung cancer
 
488

 
438

 
282

 
11

 
55

Inlyta
 
Advanced renal cell carcinoma (RCC)
 
430

 
410

 
319

 
5

 
28

FSME-IMMUN/TicoVac
 
Tick-borne encephalitis vaccine
 
104

 

 

 
*

 

All other V/O(e)
 
Various
 
298

 
211

 
164

 
41

 
29

Consumer Healthcare
 
Various
 
3,395

 
3,446

 
3,342

 
(1
)
 
3

ESTABLISHED PRODUCTS BUSINESS(g)
 
$
21,587

 
$
25,149

 
$
27,619

 
(14
)
 
(9
)
Legacy Established Products(h)
 
$
11,745

 
$
13,016

 
$
14,089

 
(10
)
 
(8
)
Lipitor
 
Reduction of LDL cholesterol
 
1,860

 
2,061

 
2,315

 
(10
)
 
(11
)
Premarin family
 
Symptoms of menopause
 
1,018

 
1,076

 
1,092

 
(5
)
 
(1
)
Norvasc
 
Hypertension
 
991

 
1,112

 
1,229

 
(11
)
 
(10
)
Xalatan/Xalacom
 
Glaucoma and ocular hypertension
 
399

 
495

 
589

 
(19
)
 
(16
)
Zoloft
 
Depression and certain anxiety disorders
 
374

 
423

 
469

 
(12
)
 
(10
)
Relpax
 
Treats the symptoms of migraine headache
 
352

 
382

 
359

 
(8
)
 
6

EpiPen
 
Epinephrine injection used in treatment of life-threatening allergic reactions
 
339

 
294

 
273

 
15

 
8

Effexor
 
Depression and certain anxiety disorders
 
288

 
344

 
440

 
(16
)
 
(22
)
Zithromax/Zmax
 
Bacterial infections
 
275

 
311

 
387

 
(11
)
 
(20
)
Xanax/Xanax XR
 
Anxiety disorders
 
224

 
253

 
276

 
(11
)
 
(8
)
Cardura
 
Hypertension/Benign prostatic hyperplasia
 
210

 
263

 
296

 
(20
)
 
(11
)
Neurontin
 
Seizures
 
196

 
210

 
216

 
(7
)
 
(3
)
Diflucan
 
Fungal infections
 
181

 
208

 
238

 
(13
)
 
(13
)
Tikosyn
 
Maintenance of normal sinus rhythm, conversion of atrial fibrillation/flutter
 
179

 
141

 
119

 
27

 
19

Depo-Provera
 
Contraceptive
 
170

 
201

 
191

 
(15
)
 
2

Unasyn
 
Injectable antibacterial
 
118

 
96

 
84

 
23

 
14

All other Legacy Established Products(e), (o)
 
Various
 
4,571

 
5,145

 
5,516

 
(11
)
 
(7
)
Peri-LOE Products(i)
 
$
5,326

 
$
8,855

 
$
10,151

 
(40
)
 
(13
)
Lyrica GEP(b)
 
Epilepsy, neuropathic pain and generalized anxiety disorder
 
1,183

 
1,818

 
1,629

 
(35
)
 
12

Zyvox
 
Bacterial infections
 
883

 
1,352

 
1,353

 
(35
)
 

Celebrex
 
Arthritis pain and inflammation, acute pain
 
830

 
2,699

 
2,918

 
(69
)
 
(8
)
Pristiq
 
Depression
 
715

 
737

 
698

 
(3
)
 
6

Vfend
 
Fungal infections
 
682

 
756

 
775

 
(10
)
 
(2
)
Viagra GEP(c)
 
Erectile dysfunction
 
411

 
504

 
701

 
(18
)
 
(28
)
Revatio
 
Pulmonary arterial hypertension (PAH)
 
260

 
276

 
307

 
(6
)
 
(10
)
All other Peri-LOE Products(e)
 
Various
 
362

 
714

 
1,770

 
(49
)
 
(60
)
Sterile Injectable Pharmaceuticals(j)
 
$
3,944

 
$
3,277

 
$
3,378

 
20

 
(3
)
Medrol
 
Inflammation
 
402

 
381

 
398

 
5

 
(4
)
Sulperazon
 
Antibiotic
 
339

 
354

 
309

 
(4
)
 
15

Fragmin
 
Anticoagulant
 
335

 
364

 
359

 
(8
)
 
2

Tygacil
 
Antibiotic
 
304

 
323

 
358

 
(6
)
 
(10
)

24
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

(MILLIONS OF DOLLARS)
 
 
 
Year Ended December 31,
 
% Change
PRODUCT
PRIMARY INDICATIONS
 
2015

 
2014

 
2013

 
15/14
 
14/13
All other Sterile Injectable Pharmaceuticals(e)
 
Various
 
2,563

 
1,855

 
1,954

 
38

 
(5
)
Infusion Systems(k)
 
Various
 
$
403

 
$

 
$

 
*

 

Biosimilars(l)
 
Various
 
$
63

 
$

 
$

 
*

 

Other Established Products(m)
 
Various
 
$
106

 
$

 
$

 
*

 

OTHER(n)
 
$
506

 
$
451

 
$
364

 
12

 
24

Total Lyrica(b)
 
Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia and neuropathic pain due to spinal cord injury
 
$
4,839

 
$
5,168

 
$
4,595

 
(6
)
 
12

Total Viagra(c)
 
Erectile dysfunction
 
$
1,708

 
$
1,685

 
$
1,881

 
1

 
(10
)
Total Alliance revenues(o)
 
Various
 
$
1,312

 
$
957

 
$
2,628

 
37

 
(64
)
(a) 
The Innovative Products business is composed of two operating segments: GIP and VOC.
(b) 
Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in Lyrica-GEP. All other Lyrica revenues are included in Lyrica-GIP. Total Lyrica revenues represent the aggregate of worldwide revenues from Lyrica-GIP and Lyrica-GEP.
(c) 
Viagra revenues from the U.S. and Canada are included in Viagra-GIP. All other Viagra revenues are included in Viagra-GEP. Total Viagra revenues represent the aggregate of worldwide revenues from Viagra-GIP and Viagra-GEP.
(d) 
Includes Eliquis, Rebif and Enbrel (in the U.S. and Canada through October 31, 2013).
(e) 
All other GIP, and All other V/O are a subset of GIP and VOC, respectively. All other Legacy Established Products, All other Peri-LOE Products and All other Sterile Injectable Pharmaceuticals are subsets of Established Products.
(f) 
In 2015, all revenues were composed of Prevnar 13/Prevenar 13. In 2014 and 2013, revenues were composed of the Prevnar family of products, which included Prevnar 13/Prevenar 13 and, to a much lesser extent, Prevenar (7-valent).
(g) 
The Established Products business consists of GEP, which includes all legacy Hospira commercial operations. Commencing from the acquisition date, September 3, 2015, and in accordance with our domestic and international reporting periods, our consolidated statement of income, primarily GEP’s operating results, for the year ended December 31, 2015 reflects four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations.
(h) 
Legacy Established Products include products that lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products).
(i) 
Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products primarily include Celebrex, Zyvox and Revatio in most developed markets, Lyrica in the EU, Pristiq in the U.S. and Inspra in the EU.
(j) 
Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
(k) 
Infusion Systems include Medication Management Systems products composed of infusion pumps and related software and services, as well as I.V. Infusion Products, including large volume I.V. solutions and their associated administration sets.
(l) 
Biosimilars include Inflectra (biosimilar infliximab), Nivestim (biosimilar filgrastim) and Retacrit (biosimilar epoetin zeta) in certain international markets.
(m) 
Includes legacy Hospira’s One-to-One contract manufacturing and bulk pharmaceutical chemical sales organizations.
(n) 
Other includes revenues from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and revenues related to our manufacturing and supply agreements with Zoetis.
(o) 
Total Alliance revenues represent the aggregate of worldwide revenues from Alliance revenues GIP and Alliance revenues GEP, which is included in All other Legacy Established Products.
*
Calculation not meaningful.

Revenues—Selected Product Descriptions

References to GIP, V, O, and GEP indicate 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.
Prevnar/Prevenar 13 (V), is our pneumococcal conjugate vaccine for the prevention of certain types of pneumococcal disease. Overall, worldwide revenues for Prevnar/Prevenar 13 increased 46% operationally in 2015, compared to 2014. Foreign exchange had an unfavorable impact on worldwide revenues of 6% in 2015, compared to 2014.
In the U.S., revenues for Prevnar increased 87% in 2015, compared to 2014, mainly due to continued strong uptake among adults following the positive recommendation from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for use in adults aged 65 and older in the third quarter of 2014 and the success of the commercial programs which helped to maximize vaccinations across all channels. We believe the “catch-up” opportunity (i.e., the opportunity to reach adults aged 65 and older who have not been previously vaccinated with Prevnar) in adults in the U.S. will continue to be large given current demographics and aging trends. However, the remaining population of adults aged 65 years and older will likely require additional effort to capture. As a result, the opportunity will moderate over time as this “catch-up” opportunity becomes fully realized.
Internationally, revenues for Prevenar increased 9% operationally in 2015, compared to 2014, primarily reflecting increased volume in emerging markets primarily due to Prevenar’s inclusion in additional national immunization programs in certain emerging markets. Foreign exchange had an unfavorable impact on international revenues of 13% in 2015, compared to 2014.
In 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults aged 65 years and older against pneumococcal disease, which for adults includes pneumonia caused by the 13 pneumococcal serotypes included in the vaccine. These ACIP recommendations were subsequently approved by the directors at the CDC and U.S. Department of Health and Human Services, and were published in the Morbidity and Mortality Weekly Report in September 2014 by the CDC. As with other vaccines, the CDC regularly monitors the impact of vaccination and reviews the recommendations; in this case, however, the CDC announced formally that it will conduct this review in 2018. Currently, we are working with a number of U.S. investigators to monitor the proportion of community-acquired pneumonia caused by the serotypes included in Prevnar 13 and continue to observe trends.
In March 2015, the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from our landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older.

2015 Financial Report    
 
 
25


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

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 were relatively flat operationally in 2015, compared to 2014. Foreign exchange had an unfavorable impact on worldwide revenues of 6% in 2015, compared to 2014.
In the U.S., revenues increased 15% in 2015, compared to 2014, driven by price and volume increases, and investment in direct-to-consumer advertising combined with strong field force performance, partially offset by higher rebates.
Internationally, Lyrica revenues decreased 11% operationally in 2015, compared to 2014, due to losses of exclusivity in certain developed Europe markets, partially offset by operational growth primarily in Japan. Foreign exchange had an unfavorable impact on international revenues of 13% in 2015, compared to 2014.
Worldwide revenues from Lyrica in our GIP segment increased 13% operationally in 2015, compared to 2014, and in our GEP segment, revenues from Lyrica decreased 23% operationally in 2015, compared to 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 a 1% operational increase in worldwide revenues, excluding the U.S. and Canada, in 2015, compared to 2014. Results were favorably impacted by demand in certain markets in Europe and the timing of government purchases in Africa Middle East offset primarily by the change in the distribution channel in the U.K. Foreign exchange had a unfavorable impact of 14% in 2015, compared to 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 $1.9 billion, or a 4% operational decrease in 2015, compared to 2014. Foreign exchange had an unfavorable impact of 6% in 2015, compared to 2014.
In the U.S., revenues decreased 33% in 2015 compared to 2014, primarily due to lower volumes and higher rebates.
In our international markets, revenues were relatively flat operationally in 2015, compared to 2014, driven by volume growth in emerging markets, primarily in China, offset by brand erosion due to generic competition and increased payer pressure in developed markets. Foreign exchange had an unfavorable impact on international revenues of 7% in 2015, compared to 2014.
Viagra (GIP (revenues from U.S. and Canada)/GEP (all other revenues excluding U.S. and Canada)) is indicated for the treatment of erectile dysfunction. Viagra worldwide revenues increased 5% operationally in 2015, compared to 2014, primarily due to operational growth in the U.S. and emerging markets. Foreign exchange had an unfavorable impact of 4% in 2015, compared to 2014. International revenues decreased 7% operationally in 2015, compared to 2014, primarily from brand erosion due to generic competition and increased payer pressure in developed markets, partially offset by volume growth in China. Foreign exchange had an unfavorable impact on international revenues of 11% in 2015, compared to 2014. Revenues in the U.S. increased 11% in 2015, compared to 2014, primarily driven by increased pill quantity per prescription, higher purchases from the U.S. Department of Veterans Affairs/Department of Defense, and price increases, partially offset by lower patient demand.
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 2015, compared to 2014, primarily due to greater demand in emerging markets as well as price increases in the U.S. Foreign exchange had an unfavorable impact of 12% in 2015, compared to 2014.
Our Premarin family of products (GEP) helps women address moderate-to-severe menopausal symptoms. Premarin worldwide revenues decreased 4% operationally in 2015, compared to 2014. Revenues in the U.S. in 2015 were unfavorably impacted by prescription volume declines and lower market growth, partially offset by price increases. Foreign exchange had an unfavorable impact of 1% in 2015, compared to 2014.
Norvasc (GEP) is indicated for the treatment of hypertension. Norvasc worldwide revenues decreased 3% operationally in 2015, compared to 2014, due to generic erosion in Japan, partially offset by volume growth in emerging markets, primarily in China. Foreign exchange had an unfavorable impact of 8% in 2015, compared to 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 27% operationally in 2015, compared to 2014. Foreign exchange had an unfavorable impact of 8% in 2015, compared to 2014.
In the U.S., revenues decreased 61% due to generic competition beginning in the first half of 2015, as well as pricing pressures.
Internationally, Zyvox revenues increased 7% operationally in 2015 compared to 2014, primarily due to volume growth in China. Foreign exchange had an unfavorable impact on international revenues of 15% in 2015, compared to 2014.
Celebrex (GEP) is 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. Celebrex recorded a 66% decrease in worldwide operational revenues in 2015, compared to 2014, primarily driven by the loss of exclusivity and associated generic competition in the U.S. and certain other developed markets. Foreign exchange had an unfavorable impact of 3% in 2015 compared to 2014.
In the U.S., revenues decreased 92% in 2015 compared to 2014, driven by the loss of exclusivity and launch of multi-source generic competition in December 2014.
Internationally, Celebrex revenues decreased 20% operationally in 2015, compared to 2014, driven by the loss of exclusivity and launch of multi-source generic competition in most developed markets. Foreign exchange had an unfavorable impact on international revenues of 9% in 2015, compared to 2014.

26
 
 
2015 Financial Report


Financial Review
Pfizer Inc. and Subsidiary Companies

 
 
 

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 5% operationally in 2015, compared to 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 7% in 2015, compared to 2014.
ReFacto AF/Xyntha recorded a 5% operational decrease in worldwide revenues in 2015, compared to 2014, largely due to price erosion in the U.K. and Australia, erosion of market share in the U.S. due to the launch of competing new extended half-life treatment options and loss of the annual 2015 contract in Iraq. Foreign exchange had an unfavorable impact on revenues of 11% in 2015, compared to 2014.
Ibrance (O) was approved and launched in the U.S., Macau, Chile and Albania as a first-line treatment for certain forms of advanced breast cancer. Ibrance recorded worldwide revenues of $723 million in 2015, nearly all of which were recorded in the U.S.
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 1% operational increase in worldwide revenues in 2015, compared to 2014. Foreign exchange had an unfavorable impact on revenues of 4% the 2015, compared to 2014.
In the U.S., Pristiq revenues were relatively flat in 2015 compared to 2014 due to price increases offset by decreased market share.
Internationally, Pristiq revenues increased 5% operationally due to volume growth in certain markets. Foreign exchange had an unfavorable impact on international revenues of 16% in 2015, compared to 2014.
Chantix/Champix (GIP) is approved as an aid to smoking-cessation treatment in adults 18 years of age and older in multiple markets worldwide. Worldwide revenues increased 9% operationally in 2015, compared to 2014. Foreign exchange had an unfavorable impact on revenues of 5% in 2015, compared to 2014.
In the U.S., Chantix revenues increased 13% in 2015, compared to 2014, primarily due to two price increases and higher year-over-year demand driven by steadily improving coverage by insurers in response to the requirements of the Affordable Care Act and direct-to-consumer advertising on TV, partially offset by intensified competition by over-the-counter nicotine replacement therapies that utilize TV and retail channels and higher-than-expected Medicaid rebates.
Internationally, Champix revenues increased 4% operationally in 2015, compared to 2014, primarily due to a significant tobacco tax increase in Korea and strong growth across emerging markets. Foreign exchange had an unfavorable impact on international revenues of 13% in 2015, compared to 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 a 72% increase in worldwide revenues operationally in 2015, compared to 2014. In the U.S., Xeljanz revenues increased 63% in 2015, compared to 2014 driven by continued adoption by rheumatologists, growing awareness among patients and price increases. Foreign exchange had a 2% unfavorable impact in 2015, compared to 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 20% operationally in 2015, compared to 2014, as a result of a steady increase in diagnostic rates for the ALK gene mutation across key markets, which has led to more patients being treated, and price increases in the U.S. Foreign exchange had a 9% unfavorable impact in 2015, compared to 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 14% operationally in 2015, compared to 2014, primarily due to increased demand across key markets with greater access and reimbursement, particularly in Europe, as well as price increases in the U.S. Foreign exchange had a 9% unfavorable impact on revenues in 2015, compared to 2014.
Alliance revenues (GEP/GIP) increased 45% operationally in 2015, compared to 2014, mainly due to:
an increase in Eliquis alliance revenues as a result of increased market share,
partially offset by:
the termination of the Spiriva (GEP) co-promotion collaboration, which resulted in a decrease of approximately $143 million operationally in 2015, compared to 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 supplies 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);
&#