EX-99 2 pfe-07032016xex99.htm EXHIBIT 99 Exhibit
Exhibit 99.1

PFIZER REPORTS SECOND-QUARTER 2016 RESULTS
Second-Quarter 2016 Revenues of $13.1 Billion, Reflecting 13% Operational Growth Driven by the Inclusion of Legacy Hospira Operations and 9% Operational Growth from Pfizer Innovative Health
Second-Quarter 2016 Revenues for Pfizer Standalone (Excluding Legacy Hospira) of $12.0 Billion, Reflecting 4% Operational Growth
Second-Quarter 2016 Reported Diluted EPS(1) of $0.33, Adjusted Diluted EPS(2) of $0.64
Reaffirmed 2016 Financial Guidance for Revenues and Adjusted Diluted EPS(2) 
NEW YORK, N.Y., Tuesday, August 2, 2016 – Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2016 and reaffirmed its 2016 financial guidance for Revenues and Adjusted Diluted EPS(2).
On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, financial results for the second quarter and first six months of 2016 include legacy Hospira global operations while financial results for the second quarter and first six months of 2015 do not include any contribution from legacy Hospira operations.
The Company manages its commercial operations through two distinct businesses: Pfizer Innovative Health (IH)(3) (formerly the Innovative Products business) and Pfizer Essential Health (EH)(3)(4) (formerly the Established Products business). Financial results for each of these businesses are presented in the Operating Segment Information section.
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange as well as the negative currency impact related to Venezuela. Results for the second quarter and first six months of 2016 and 2015 are summarized below.
OVERALL RESULTS
 
 
 
 
 
 
 
 
 
($ in millions, except
per share amounts)
Second-Quarter
 
 
Six Months
 
2016
2015
Change
 
 
2016
2015
Change
Revenues
$ 13,147

$ 11,853

11%
 
 
$ 26,152

$ 22,717

15%
Reported Net Income(1)
2,019

2,626

(23%)
 
 
5,036

5,002

1%
Reported Diluted EPS(1)
0.33

0.42

(21%)
 
 
0.82

0.80

3%
Adjusted Net Income(2)
3,901

3,525

11%
 
 
8,056

6,721

20%
Adjusted Diluted EPS(2)
0.64

0.56

14%
 
 
1.30

1.07

21%
 
 
 
 
 
 
 
 
 

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REVENUES
 
 
 
 
 
 
 
 
 
 
 
($ in millions)
Second-Quarter
 
 
Six Months
 
2016
2015
% Change
 
 
2016
2015
% Change
 
Total
Oper.
 
 
Total
Oper.
Innovative Health
$ 7,105

$ 6,630

7%
9%
 
 
$ 14,139

$ 12,368

14%
18%
Essential Health
$ 6,042

$ 5,223

16%
19%
 
 
$ 12,013

$ 10,348

16%
22%
EH Standalone
(Excl. Legacy Hospira)
4,904

5,223

(6%)
(3%)
 
 
9,676

10,348

(6%)
(1%)
Legacy Hospira
1,138


*
*
 
 
2,337


*
*
Total Company
$ 13,147

$ 11,853

11%
13%
 
 
$ 26,152

$ 22,717

15%
20%
 
 
 
 
 
 
 
 
 
 
 
Pfizer Standalone
(Excl. Legacy Hospira)
$ 12,009

$ 11,853

1%
4%
 
 
$ 23,815

$ 22,717

5%
9%
 
 
 
 
 
 
 
 
 
 
 
* Indicates calculation not meaningful.
2016 FINANCIAL GUIDANCE(5) 
Pfizers reaffirmed 2016 financial guidance is presented below:
 
 
Revenues
$51.0 to $53.0 billion
Adjusted Cost of Sales(2) as a Percentage of Revenues
21.0% to 22.0%
Adjusted SI&A Expenses(2)
$13.7 to $14.7 billion
Adjusted R&D Expenses(2)
$7.4 to $7.8 billion
Adjusted Other (Income)/Deductions(2)
Approximately ($500 million) of income
Effective Tax Rate on Adjusted Income(2)
Approximately 24.0%
Adjusted Diluted EPS(2)
$2.38 to $2.48
 
 
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, “Our continued sharp focus on executing against the distinct strategies for both our Innovative Health and Essential Health businesses has delivered a strong financial performance during the second quarter as well as for the first half of 2016. This performance was driven by all areas of the company, reflecting ongoing strength from our recent product launches and key in-line products, the contribution of legacy Hospira products, continued improvement in the revenue profile for our standalone Essential Health business, the advancement of our product pipeline and sound capital allocation choices.

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“Furthermore, I see our product pipeline along with the assets obtained from our recent business development initiatives as positioning the Company competitively in those areas where I believe Pfizer’s strengths can generate significant shareholder value over time while also benefiting patients,” Mr. Read concluded.
Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am pleased with our second-quarter 2016 financial results and with our ability to continue delivering shareholder value through prudent capital allocation. We grew revenues by 4% operationally, excluding the impact of foreign exchange and legacy Hospira operations. We also continued to deliver significant value directly to shareholders by returning $8.7 billion to shareholders through dividends and share repurchases in the first half of 2016, including the completion of a $5 billion accelerated share repurchase agreement in June 2016. Additionally, we announced and completed the acquisition of Anacor Pharmaceuticals, Inc. (Anacor) in the second quarter of 2016. We also reaffirmed our 2016 financial guidance for Revenues and Adjusted Diluted EPS(2), reflecting the overall strength of our businesses and our confidence in their outlooks going forward.”
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2016 vs. Second-Quarter 2015)
Revenues totaled $13.1 billion, an increase of $1.3 billion, or 11%, which reflects operational growth of $1.6 billion, or 13%, partially offset by the unfavorable impact of foreign exchange of $302 million, or 3%. Excluding the contribution of legacy Hospira operations of $1.1 billion and foreign exchange, Pfizer-standalone revenues increased by $458 million operationally, or 4%.
Revenues in developed markets grew $1.5 billion, or 17%, operationally, driven primarily by the inclusion of $1.1 billion of revenues from legacy Hospira operations and continued strong performance of several key products, notably Ibrance in the U.S., Eliquis, as well as Xeljanz and Lyrica, both primarily in the U.S. Operational revenue growth in developed markets was partially offset primarily by lower revenues for Prevnar 13 in the U.S., the loss of exclusivity and associated generic competition for Zyvox, primarily in the U.S. and certain developed Europe markets, and Lyrica in certain developed Europe markets, as well as the December 31, 2015 expiration of the collaboration agreement to co-promote Rebif in the U.S.
In emerging markets, revenues increased $116 million, or 4%, operationally, reflecting the favorable impact of the addition of legacy Hospira operations, which contributed $78 million and the performance of certain Essential Health products primarily in China partially offset primarily by lower revenues for Prevenar 13.
Innovative Health Highlights
IH revenues increased 9% operationally, primarily due to continued strong momentum from Ibrance in the U.S., strong operational growth from Eliquis globally as well as Lyrica and Xeljanz, both primarily in the U.S. This growth was partially offset by the expected decline in revenues for Prevnar 13 for adults in the U.S. due to a high initial capture rate of the eligible population following its successful fourth-quarter 2014

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launch, which resulted in a smaller remaining “catch up” opportunity compared to the prior-year quarter. International revenues for the pediatric indication for Prevenar 13 declined, primarily in emerging markets, reflecting timing of purchases from Gavi, the Vaccine Alliance, and certain other markets, compared to the prior-year quarter. Additionally, IH revenues were impacted by the expiration of the collaboration agreement to co-promote Rebif in the U.S., which expired at the end of 2015.
Essential Health Highlights
EH revenues increased 19% operationally, primarily due to the inclusion of legacy Hospira operations, which contributed $1.1 billion, partially offset by the loss of exclusivity and associated generic competition for certain Peri-LOE Products(6), primarily Zyvox in the U.S. and certain developed Europe markets as well as Lyrica in certain developed Europe markets. Revenues excluding the contribution from the legacy Hospira portfolio (EH Standalone) declined 3% operationally, reflecting a 19% operational decline from the aforementioned Peri-LOE Products portfolio, partially offset by 11% operational growth from the EH Standalone Sterile Injectable Pharmaceuticals(6) portfolio and 2% operational growth from EH Standalone Legacy Established Products(6). EH revenues in emerging markets increased 8% operationally, primarily driven by the inclusion of legacy Hospira operations and operational growth from the EH Standalone Sterile Injectable Pharmaceuticals portfolio.
GAAP Reported(1) Income Statement Highlights
SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(1) 
 
 
 
 
 
 
 
 
 
 
 
($ in millions)
(Favorable)/Unfavorable
Second-Quarter
 
 
Six Months
 
2016
2015
% Change
 
 
2016
2015
% Change
 
Total
Oper.
 
 
Total
Oper.
Cost of Sales(1)
$ 3,174

$ 2,180

46%
37%
 
 
$ 6,026

$ 4,018

50%
46%
Percent of Revenues
24.1
%
18.4
%
N/A
N/A
 
 
23.0
%
17.7
%
N/A
N/A
SI&A Expenses(1)
 3,471

 3,386

2%
5%
 
 
 6,856

 6,491

6%
9%
R&D Expenses(1)
 1,748

 1,734

1%
1%
 
 
 3,478

 3,620

(4%)
(3%)
Total
$ 8,392

$ 7,301

15%
14%
 
 
$ 16,359

$ 14,129

16%
16%
 
 
 
 
 
 
 
 
 
 
 
Effective Tax Rate(1)
15.6
%
25.6
%
 
 
 
 
15.2
%
24.3
%
 
 
 
 
 
 
 
 
 
 
 
 
 
The diluted weighted-average shares outstanding declined by 106 million shares compared to the prior-year quarter due to Pfizer’s share repurchase program, primarily reflecting the impact of a $5 billion accelerated share repurchase agreement executed in March 2016 and completed in June 2016.

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Adjusted(2) Income Statement Highlights
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2) 
 
 
 
 
 
 
 
 
 
 
 
($ in millions)
(Favorable)/Unfavorable
Second-Quarter
 
 
Six Months
 
2016
2015
% Change
 
 
2016
2015
% Change
 
Total
Oper.
 
 
Total
Oper.
Adjusted Cost of Sales(2)
$ 3,062

$ 2,123

44%
35%
 
 
$ 5,627

$ 3,930

43%
39%
Percent of Revenues
23.3
%
17.9
%
N/A
N/A
 
 
21.5
%
17.3
%
N/A
N/A
Adjusted SI&A Expenses(2)
 3,443

 3,372

2%
5%
 
 
 6,811

 6,449

6%
9%
Adjusted R&D Expenses(2)
 1,740

 1,732

1%
 
 
 3,463

 3,609

(4%)
(4%)
Total
$ 8,246

$ 7,226

14%
13%
 
 
$ 15,901

$ 13,988

14%
14%
 
 
 
 
 
 
 
 
 
 
 
Effective Tax Rate on Adjusted Income(2)
23.2
%
25.6
%
 
 
 
 
23.5
%
25.0
%
 
 
 
 
 
 
 
 
 
 
 
 
 
A full reconciliation of Reported(1) to Adjusted(2) financial measures and associated footnotes can be found starting on page 17 of this press release.
RECENT NOTABLE DEVELOPMENTS
Product Developments
Chantix/Champix (varenicline) -- Pfizer announced in May 2016 that the European Summary of Product Characteristics and Package Leaflet for Champix have been updated to include safety and efficacy data from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial. As part of the update, the black triangle symbol, which indicated that additional safety monitoring for Champix in the EU was required, has been removed.
Ibrance (palbociclib) -- In June 2016, Pfizer presented final results from the Phase 3 PALOMA-2 trial for Ibrance, an oral, first-in-class inhibitor of cyclin-dependent kinases 4 and 6, as an oral presentation at the American Society of Clinical Oncology 2016 Annual Meeting (ASCO 2016). The study met its primary endpoint by demonstrating an improvement in progression-free survival (PFS) for the combination of Ibrance plus letrozole compared with letrozole plus placebo in post-menopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced or metastatic breast cancer who had not received previous systemic treatment for their advanced disease. The PALOMA-2 trial provides confirmatory evidence for Ibrance in combination with letrozole in the first-line setting, which was first evaluated in the Phase 2 PALOMA-1 trial. These data will support additional planned global regulatory submissions and a request for conversion of the accelerated approval for Ibrance to regular approval in the U.S.

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Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) -- Pfizer announced in July 2016 that it received U.S. Food and Drug Administration (FDA) approval for an expanded age indication for Prevnar 13 to include adults 18 through 49 years of age, in addition to the already approved indications for adults 50 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains in the vaccine and for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae strains in the vaccine.
Sutent (sunitinib malate) -- Pfizer announced in July 2016 positive top-line results from the S-TRAC (Sunitinib Trial in Adjuvant Renal Cancer) trial, a Phase 3 study of Sutent versus placebo in the adjuvant setting. The study met its primary endpoint of improving disease-free survival (DFS) in patients with renal cell carcinoma (RCC) who are at high risk for recurrence after surgery. The S-TRAC trial is the first RCC trial of a tyrosine kinase inhibitor to prolong DFS in the adjuvant setting. Full efficacy and safety data will be submitted for presentation at the European Society for Medical Oncology (ESMO) 2016 Congress in October 2016.
Trumenba (Meningococcal Group B vaccine) -- Pfizer announced in May 2016 that the European Medicines Agency has accepted the Marketing Authorization Application for Trumenba for review. Trumenba has been developed for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 years and older and was approved in the U.S. in October 2014.
Xalkori (crizotinib) -- In July 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending extension of the current indication of Xalkori in the EU to also include the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). The CHMP recommendation will now be reviewed by the European Commission, which is expected to issue a decision on whether to extend the EU indication in the coming months. This recommendation is based on efficacy and safety data from the Phase 1 PROFILE 1001 trial of crizotinib.
Xeljanz (tofacitinib citrate)
Pfizer announced in July 2016 positive top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third Phase 3 study of Xeljanz being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies. Top-line results from the OCTAVE Sustain study showed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 mg and 10 mg BID groups compared to placebo. No new or unexpected safety findings for tofacitinib were observed in the study. Detailed analyses of OCTAVE Sustain, including additional efficacy data, will be submitted for presentation at a

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future scientific meeting.
Pfizer recently withdrew all pending regulatory applications seeking approval of tofacitinib for the treatment of adult patients with moderate to severe chronic plaque psoriasis, including its supplemental new drug application in the U.S. following the October 2015 Complete Response Letter from the FDA. The withdrawal of these filings will allow Pfizer more time to determine the path forward for tofacitinib in this indication. Pfizer remains committed to advancing the tofacitinib clinical development program for rheumatoid arthritis, psoriatic arthritis (PsA) and UC.
Pfizer announced in June 2016 positive top-line results from its second Phase 3 study investigating tofacitinib for the treatment of PsA in adult patients, Oral Psoriatic Arthritis triaL (OPAL) Beyond. The study met its primary efficacy endpoints with tofacitinib 5 mg BID and 10 mg BID compared to placebo treatment.
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for candidates from Phase 2 through registration.
ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) -- In June 2016, Pfizer announced that the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted (9 to 6) in favor of approval of ALO-02 extended-release capsules for its proposed indication, “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling for the oral route (6 to 9). The FDA will take the Committees’ recommendations into consideration before taking action on the New Drug Application (NDA) for ALO-02.
Avelumab (MSB0010718C)
In July 2016, Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer announced the initiation of a Phase 3 study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage 3 or Stage 4) with previously untreated epithelial ovarian cancer. JAVELIN Ovarian 100 is the first Phase 3 study evaluating the addition of an immune checkpoint inhibitor to standard-of-care in first-line treatment for this aggressive disease.

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In June 2016, Merck KGaA and Pfizer presented data for avelumab across seven different cancers at ASCO 2016. The avelumab presentations, from the JAVELIN clinical development program, included results from a number of difficult-to-treat cancers, including data from the pivotal Phase 2 trial of avelumab as a potential second-line treatment for metastatic Merkel cell carcinoma. Additional avelumab data was presented in mesothelioma, adrenocortical carcinoma, NSCLC, and urothelial bladder, gastric and ovarian cancers, as well as updated safety data.
Bococizumab (PF-04950615, RN316) -- In June 2016, Pfizer announced positive top-line results for two additional Phase 3 trials, SPIRE-HR (High Risk) and SPIRE-FH (Familial Hypercholesterolemia). Both studies met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a maximally tolerated dose of a statin. SPIRE-HR and SPIRE-FH are the third and fourth of six Phase 3 lipid-lowering studies to complete and demonstrate positive top-line results. The two remaining Phase 3 lipid-lowering studies are anticipated to complete later in 2016.
Crisaborole Topical Ointment, 2% (AN2728) -- In July 2016, Pfizer announced that the findings from two pivotal Phase 3 studies of investigational crisaborole were published in the online issue of the Journal of the American Academy of Dermatology. The detailed results from the AD-301 and AD-302 studies showed that crisaborole achieved statistically significant results on primary and secondary endpoints for the treatment of atopic dermatitis in children two years of age and up and in adults compared to vehicle ointment alone. Crisaborole was obtained by Pfizer as part of the acquisition of Anacor, which was completed in June 2016.
Ertugliflozin (PF-04971729) -- Pfizer and Merck, known as MSD outside the U.S. and Canada, announced in June 2016 that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, both met their primary endpoints. Full results from the VERTIS clinical development program of ertugliflozin were presented for the first time in June 2016 at the Scientific Sessions of the American Diabetes Association. The companies also reaffirmed their plans to submit NDAs to the FDA for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus Januvia®(7) and ertugliflozin plus metformin) by the end of 2016.
Inotuzumab Ozogamicin -- Pfizer announced in June 2016 the final results from the Phase 3 INO-VATE ALL study evaluating the safety and efficacy of inotuzumab ozogamicin as compared with investigator choice chemotherapy in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia. Results were presented as a late-breaking oral presentation (#LB2233) at the 21st Congress of the European Hematology Association (EHA) 2016 Annual Meeting. Final results were also published in the June 12, 2016 online issue of The New England Journal of Medicine.

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Lorlatinib (PF-06463922) -- In June 2016, Pfizer presented encouraging new data from a Phase 1/2 study of lorlatinib (the proposed non-proprietary name for PF-06463922), an investigational, next-generation ALK/ROS1 tyrosine kinase inhibitor, in an oral presentation at ASCO 2016. The study showed clinical response in patients with ALK-positive or ROS1-positive advanced NSCLC, including patients with brain metastases. The ongoing Phase 2 study is expected to enroll a total of 240 patients across six cohorts (five for ALK-positive and one for ROS1-positive patients with NSCLC), with enrollment defined by degree and type of prior treatment.
SPK-9001 -- Spark Therapeutics and Pfizer announced in July 2016 that the FDA has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’ SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant, is being investigated in an ongoing Phase 1/2 trial as a potential one-time therapy.
Utomilumab (PF-05082566) -- In June 2016, Pfizer presented results from a Phase 1b trial of Pfizer’s investigational immunotherapy agent utomilumab (the proposed non-proprietary name for PF-05082566), a 4-1BB (also called CD137) agonist, in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced solid tumors. This is the first reported study of a 4-1BB agonist combined with a checkpoint inhibitor. Encouraging safety data from the study were shared in an oral presentation at ASCO 2016. Pfizer is investigating utomilumab as a single agent in certain solid tumors and in combinations across multiple solid tumors and hematological malignancies, including with rituximab in lymphoma and with other immunotherapies, including Pfizer's OX40 agonist (PF-04518600), Kyowa Hakko Kirin's anti-CCR4 (mogamulizumab) and avelumab (Merck KGaA and Pfizer alliance).
Corporate Developments
In August 2016, Pfizer acquired all remaining equity in Bamboo Therapeutics, Inc. (Bamboo), a privately held biotechnology company based in Chapel Hill, N.C., that is focused on developing gene therapies for the treatment of patients with certain rare diseases, for an upfront payment of $150 million plus potential milestone payments to Bamboo’s selling shareholders of up to $495 million, contingent upon the progression of key assets through development, regulatory approval and commercialization. Pfizer had previously acquired a 22% stake in Bamboo in the first quarter of 2016 for a payment of approximately $43 million. This acquisition will provide Pfizer with several clinical and pre-clinical assets that complement Pfizer's rare disease portfolio, an advanced AAV vector design and production technology, and a fully functional Phase 1/2 gene therapy manufacturing facility. Following the acquisition, Bamboo is now a wholly-owned subsidiary of Pfizer.
In July 2016, Pfizer and Western Oncolytics announced that the companies have entered into a development collaboration, license and option agreement to advance Western Oncolytics’ novel oncolytic

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vaccinia virus, WO-12. Oncolytic viruses are viruses engineered to kill cancer cells while sparing healthy cells, which subsequently elicits anti-cancer immune responses. This collaboration in oncolytic virus development adds another novel technology platform to Pfizer’s cancer vaccine efforts and provides an additional tool to bolster its immuno-oncology portfolio. Under the terms of the agreement, Pfizer and Western Oncolytics will collaborate on preclinical and clinical development of WO-12 through Phase 1 trials. Following completion of Phase 1 trials, Pfizer has an exclusive option to acquire WO-12. Financial terms of the agreement were not disclosed.
In June 2016, Pfizer announced that it completed its acquisition of Anacor for $99.25 in cash (without interest but subject to required withholding of taxes) per share of Anacor common stock, for a total transaction value, net of cash and cash equivalents, of approximately $5.2 billion.
Pfizer announced in March 2016 that it entered into an accelerated share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to repurchase $5 billion of Pfizer’s common stock. Pursuant to the terms of the agreement, on March 10, 2016, Pfizer paid $5 billion to GS&Co. and received an initial delivery of approximately 136 million shares of Pfizer common stock from GS&Co. Upon settlement of the agreement in June 2016 and pursuant to the agreement's settlement terms, GS&Co. delivered approximately 18 million additional shares of Pfizer common stock to Pfizer. After giving effect to the accelerated share repurchase agreement, Pfizer's remaining share-purchase authorization was approximately $11.4 billion as of August 2, 2016.

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For additional details, see the attached financial schedules, product revenue tables and disclosure notice.
(1)
Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as reported diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(2)
Adjusted income and its components and Adjusted diluted EPS are defined as reported U.S. GAAP net income(1) and its components and reported diluted EPS(1) excluding purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items (some of which may recur, such as restructuring or legal charges, but which management does not believe are reflective of our ongoing core operations). Adjusted cost of sales, Adjusted selling, informational and administrative (SI&A) expenses, Adjusted research and development (R&D) expenses and Adjusted other (income)/deductions are income statement line items prepared on the same basis as, and therefore components of, the overall Adjusted income measure. As described in the Management's Discussion and Analysis of Financial Condition and Results of Operations––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer's Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2016, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income, and certain components of Adjusted income, in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines, vaccines, medical devices and consumer healthcare (OTC) products––prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the second quarter and first six months of 2016 and 2015. The Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS.
(3)
Effective in second-quarter 2016, Pfizer's operating structure was reorganized from three segments to two to reflect changes to how the innovative pharmaceutical, vaccine and consumer healthcare operations are managed. Pfizer Innovative Health was previously known as the Innovative Products business, which was comprised of the Global Innovative Pharmaceutical (GIP) and Global Vaccines, Oncology and Consumer Healthcare (VOC) segments. Additionally, the name of Pfizer's Established Products business, which consisted of the Global Established Pharmaceutical (GEP) segment, was changed to Pfizer Essential Health. For a description of the revenues in each business, see the Notes to Operating Segment Information section of this press release, which can be found on page 23.

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(4)
Effective as of the beginning of 2016, Pfizer’s entire contract manufacturing business, Pfizer CentreOne, is now part of Pfizer Essential Health. Pfizer CentreOne consists of (i) legacy Pfizer’s contract manufacturing and active pharmaceutical ingredient sales operation, including manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) legacy Hospira’s One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside of Pfizer's operating segments and its revenues were reported as other business activities. Prior period PCS operating results have been reclassified to conform to the current period presentation as part of Essential Health.
(5)
The 2016 financial guidance reflects the following:
Pfizer does not provide guidance for GAAP Reported financial measures (other than Revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of pending litigation, unusual gains and losses, acquisition-related expenses and potential future asset impairments without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
Does not assume the completion of any business development transactions not completed as of July 3, 2016, including any one-time upfront payments associated with such transactions.
Exchange rates assumed are a blend of the actual exchange rates in effect through second-quarter 2016 and mid-July 2016 exchange rates for the remainder of the year.
Guidance for 2016 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 revenues also reflects the anticipated negative impact of $1.4 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 adjusted diluted EPS(2) resulting from unfavorable changes in foreign exchange rates compared to foreign exchange rates from 2015 is approximately $0.10, including $0.07 due to the estimated significant negative currency impact related to Venezuela.
Guidance for adjusted diluted EPS(2) assumes diluted weighted-average shares outstanding of approximately 6.2 billion shares.

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(6)
The following are certain product categories within Essential Health:
Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products primarily include Lyrica in certain developed Europe markets, Pristiq globally, Celebrex, Zyvox and Revatio in most developed markets, Vfend and Viagra in certain developed Europe markets and Japan, and Inspra in the EU.
Legacy Established Products include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products).
Definitions for all Essential Health product categories can be found in the footnotes to the product revenue tables on page 32 of this press release.
(7)
Januvia® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Contacts:
Media
 
Investors
 
 
Joan Campion
212.733.2798
Chuck Triano
212.733.3901
 
 
 
Ryan Crowe
212.733.8160
 
 
 
Bryan Dunn
212.733.8917


- 13 -


PFIZER INC. AND SUBSIDIARY COMPANIES
CONSOLIDATED STATEMENTS OF INCOME(1) 
(UNAUDITED)
(millions, except per common share data)


 
 
Second-Quarter
 
% Incr. /
 
Six Months
 
% Incr. /
 
 
2016

 
2015

 
(Decr.)
 
2016

 
2015

 
(Decr.)
Revenues(2)
 
$
13,147

 
$
11,853

 
11
 
$
26,152

 
$
22,717

 
15
Costs and expenses:
 
 
 
 
 
 
 
 
 
 
 
 
Cost of sales(3), (4)
 
3,174

 
2,180

 
46
 
6,026

 
4,018

 
50
Selling, informational and administrative expenses(3), (4)
 
3,471

 
3,386

 
2
 
6,856

 
6,491

 
6
Research and development expenses(3), (4)
 
1,748

 
1,734

 
1
 
3,478

 
3,620

 
(4)
Amortization of intangible assets(4)
 
961

 
872

 
10
 
1,966

 
1,811

 
9
Restructuring charges and certain acquisition-related costs(5)
 
316

 
86

 
*
 
457

 
146

 
*
Other (income)/deductions––net(6)
 
1,068

 
55

 
*
 
1,398

 
9

 
*
 
 
 
 
 
 
 
 
 
 
 
 
 
Income from continuing operations before provision for taxes on income
 
2,410

 
3,539

 
(32)
 
5,971

 
6,621

 
(10)
Provision for taxes on income(7)
 
375

 
905

 
(59)
 
910

 
1,610

 
(43)
Income from continuing operations
 
2,035

 
2,635

 
(23)
 
5,060

 
5,011

 
1
Discontinued operations––net of tax
 
1

 
1

 
(14)
 
1

 
6

 
(89)
Net income before allocation to noncontrolling interests
 
2,035

 
2,635

 
(23)
 
5,061

 
5,017

 
1
Less: Net income attributable to noncontrolling interests
 
16

 
9

 
82
 
25

 
14

 
77
Net income attributable to Pfizer Inc.
 
$
2,019

 
$
2,626

 
(23)
 
$
5,036

 
$
5,002

 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
Earnings per common share––basic:
 
 
 
 
 
 
 
 
 
 
 
 
Income from continuing operations attributable to Pfizer Inc. common shareholders
 
$
0.33

 
$
0.43

 
(23)
 
$
0.82

 
$
0.81

 
1
Discontinued operations––net of tax
 

 

 
 

 

 
Net income attributable to Pfizer Inc. common shareholders
 
$
0.33

 
$
0.43

 
(23)
 
$
0.82

 
$
0.81

 
1
 
 
 
 
 
 
 
 
 
 
 
 
 
Earnings per common share––diluted:
 
 
 
 
 
 
 
 
 
 
 
 
Income from continuing operations attributable to Pfizer Inc. common shareholders
 
$
0.33

 
$
0.42

 
(21)
 
$
0.82

 
$
0.80

 
3
Discontinued operations––net of tax
 

 

 
 

 

 
Net income attributable to Pfizer Inc. common shareholders
 
$
0.33

 
$
0.42

 
(21)
 
$
0.82

 
$
0.80

 
3
Weighted-average shares used to calculate earnings per common share:
 
 
 
 
 
 
 
 
 
 
 
 
Basic
 
6,068

 
6,159

 
 
 
6,110

 
6,181

 
 
Diluted
 
6,137

 
6,243

 
 
 
6,176

 
6,267

 
 
*
Calculation not meaningful.
See end of tables for notes (1) through (7).
Amounts may not add due to rounding. All percentages have been calculated using unrounded amounts.


- 14 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)

(1)
The financial statements present the three and six months ended July 3, 2016 and June 28, 2015. Subsidiaries operating outside the U.S. are included for the three and six months ended May 29, 2016 and May 24, 2015.
The financial results for the three and six months ended July 3, 2016 are not necessarily indicative of the results that ultimately could be achieved for the full year.
The financial results of Hospira, Inc. (Hospira) are included in our consolidated financial statements commencing from the acquisition date of September 3, 2015. Therefore, our second-quarter and first six months of 2015 results of operations do not include Hospira's results of operations. Amortization of intangible assets for 2016 includes the amortization of intangible assets acquired from Hospira.
Certain amounts in the consolidated statements of income and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.
(2)
Compared with the first six months of 2015, revenues for the first six months of 2016 were favorably impacted by approximately $800 million as a result of first-half 2016 having four additional selling days in the U.S. and four additional selling days in international markets.
(3)
Exclusive of amortization of intangible assets, except as discussed in footnote (4) below.
(4)
Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets, as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses and/or Research and development expenses, as appropriate.
(5)
Included in Restructuring charges and certain acquisition-related costs are (i) restructuring charges of $140 million in the second quarter of 2016 and $170 million for the first six months of 2016 for employee termination costs, exit costs and asset impairments, which are largely associated with cost-reduction and productivity initiatives not associated with acquisitions; (ii) transaction costs, such as banking, legal, accounting and other similar services, of $36 million in the second quarter of 2016, most of which are directly related to our acquisition of Anacor Pharmaceuticals, Inc. (Anacor) in June 2016, and $60 million for the first six months of 2016, most of which are directly related to our acquisition of Anacor and the terminated transaction with Allergan plc (Allergan); and (iii) integration costs, representing external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes, of $139 million in the second quarter of 2016 and $227 million for the first six months of 2016, primarily related to our acquisition of Hospira and the terminated transaction with Allergan.
(6)
Other (income)/deductions––net includes the following:
 
 
Second-Quarter
 
Six Months
(MILLIONS OF DOLLARS)
 
2016

 
2015

 
2016

 
2015

Interest income(a)
 
$
(122
)
 
$
(119
)
 
$
(234
)
 
$
(211
)
Interest expense(a)
 
292

 
278

 
598

 
587

Net interest expense
 
170

 
159

 
363

 
375

Royalty-related income
 
(274
)
 
(257
)
 
(461
)
 
(479
)
Certain legal matters, net(b)
 
261

 
99

 
534

 
99

Net gains on asset disposals(c)
 
(31
)
 
(19
)
 
(39
)
 
(195
)
Certain asset impairments(d)
 
816

 
25

 
947

 
25

Business and legal entity alignment costs(e)
 
60

 
63

 
111

 
164

Other, net(f)
 
66

 
(15
)
 
(57
)
 
20

Other (income)/deductions––net
 
$
1,068

 
$
55

 
$
1,398

 
$
9

(a)
Interest income increased in the second quarter and first six months of 2016, primarily due to higher investment returns. Interest expense increased in the second quarter and first six months of 2016, primarily due to interest on legacy Hospira debt acquired in September 2015 and the addition of new fixed rate debt in the second quarter of 2016, partially offset by the maturity of other fixed rate debt.
(b)
In the second quarter and first six months of 2016, primarily includes amounts to resolve a Multi-District Litigation relating to Celebrex and Bextra pending against the Company in New York federal court for $486 million, which is subject to the negotiation of a final settlement agreement and court approval, a portion of which was accrued for during the first quarter of 2016 and the full amount of which was accrued for during the first six months of 2016, partially offset by the reversal of a legal accrual where a loss is no longer deemed probable. In

- 15 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)

addition, the first six months of 2016 includes a settlement related to a patent matter.
(c)
In the first six months of 2016, primarily includes gains on sales/out-licensing of product and compound rights (approximately $31 million). In the first six months of 2015, primarily includes gains on sales/out-licensing of product and compound rights (approximately $69 million) and gains on sales of investments in equity securities (approximately $125 million).
(d)
In the second quarter and first six months of 2016, primarily includes: (i) intangible asset impairment charges of $641 million, primarily related to developed technology rights for a generic injectable antibiotic product for the treatment of bacterial infections and an in-process research and development (IPR&D) compound for the treatment of anemia, both acquired in connection with our acquisition of Hospira; and (ii) impairment losses of $130 million in the second quarter of 2016 and $211 million in the first six months of 2016 related to Pfizer's 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. in China. The first six months of 2016 also includes an impairment loss of $50 million related to Pfizer's 40%-owned equity-method investment in Laboratório Teuto Brasileiro S.A.
(e)
In the second quarter and first six months of 2016 and 2015, represents expenses for changes to our infrastructure to align our commercial operations, including costs to internally separate our businesses into distinct legal entities, as well as to streamline our intercompany supply operations to better support each business.
(f)
In the second quarter and first six months of 2016, primarily includes, among other things, $150 million paid to Allergan for reimbursement of Allergan's expenses associated with the terminated transaction. The first six months of 2016 also includes $116 million from resolution of a contract disagreement.
(7)
The decrease in the effective tax rate for the second quarter of 2016 compared to the second quarter of 2015 was primarily due to (i) the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, as well as (ii) an increase in benefits associated with the U.S. R&D tax credit, which was not in effect in the prior year quarter but was permanently extended on December 18, 2015.
The decrease in the effective tax rate for the first six months of 2016 compared to the first six months of 2015 was primarily due to (i) benefits related to the final resolution (pending court approval) of an agreement in principle reached in February 2016 to resolve certain claims related to Protonix, which resulted in the receipt of information that raised our assessment of the likelihood of prevailing on the technical merits of our tax position, (ii) a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, (iii) benefits associated with our Venezuela operations, (iv) an increase in benefits associated with the U.S. R&D tax credit, which was not in effect in the first six months of the prior year but was permanently extended on December 18, 2015, as well as (v) an increase in benefits associated with the resolution of certain tax positions pertaining to prior years primarily with various foreign tax authorities, and the expiration of certain statutes of limitations.

- 16 -


PFIZER INC. AND SUBSIDIARY COMPANIES
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION(1) 
CERTAIN LINE ITEMS
(UNAUDITED)
(millions of dollars, except per common share data)

 
Second-Quarter 2016
 
GAAP Reported(2)
 
Purchase Accounting Adjustments
 
Acquisition-Related Costs(3)
 
Discontinued Operations
 
Certain Significant Items(4)
 
Non-GAAP Adjusted(5)
Revenues
$
13,147

 
$

 
$

 
$

 
$

 
$
13,147

Cost of sales(6), (7)
3,174

 
(52
)
 

 

 
(60
)
 
3,062

Selling, informational and administrative expenses(6), (7)
3,471

 
(7
)
 

 

 
(21
)
 
3,443

Research and development expenses(6), (7)
1,748

 
(1
)
 

 

 
(6
)
 
1,740

Amortization of intangible assets(7)
961

 
(930
)
 

 

 

 
31

Restructuring charges and certain acquisition-related costs
316

 

 
(202
)
 

 
(114
)
 

Other (income)/deductions––net
1,068

 
7

 

 

 
(1,305
)
 
(230
)
Income from continuing operations before provision for taxes on income
2,410

 
984

 
202

 

 
1,506

 
5,101

Provision for taxes on income
375

 
272

 
73

 

 
463

 
1,184

Income from continuing operations
2,035

 
712

 
129

 

 
1,042

 
3,917

Discontinued operations––net of tax
1

 

 

 
(1
)
 

 

Net income attributable to noncontrolling interests
16

 

 

 

 

 
16

Net income attributable to Pfizer Inc.
2,019

 
712

 
129

 
(1
)
 
1,042

 
3,901

Earnings per common share attributable to Pfizer Inc.––diluted
0.33

 
0.12

 
0.02

 

 
0.17

 
0.64

 
Six Months Ended July 3, 2016
 
GAAP Reported(2)
 
Purchase Accounting Adjustments
 
Acquisition-Related Costs(3)
 
Discontinued Operations
 
Certain Significant Items(4)
 
Non-GAAP Adjusted(5)
Revenues
$
26,152

 
$

 
$

 
$

 
$

 
$
26,152

Cost of sales(6), (7)
6,026

 
(252
)
 

 

 
(147
)
 
5,627

Selling, informational and administrative expenses(6), (7)
6,856

 
(8
)
 

 

 
(36
)
 
6,811

Research and development expenses(6), (7)
3,478

 
1

 

 

 
(16
)
 
3,463

Amortization of intangible assets(7)
1,966

 
(1,905
)
 

 

 

 
61

Restructuring charges and certain acquisition-related costs
457

 

 
(317
)
 

 
(140
)
 

Other (income)/deductions––net
1,398

 
27

 

 

 
(1,805
)
 
(380
)
Income from continuing operations before provision for taxes on income
5,971

 
2,137

 
317

 

 
2,144

 
10,569

Provision for taxes on income
910

 
596

 
(26
)
 

 
1,007

 
2,487

Income from continuing operations
5,060

 
1,541

 
344

 

 
1,136

 
8,081

Discontinued operations––net of tax
1

 

 

 
(1
)
 

 

Net income attributable to noncontrolling interests
25

 

 

 

 

 
25

Net income attributable to Pfizer Inc.
5,036

 
1,541

 
344

 
(1
)
 
1,136

 
8,056

Earnings per common share attributable to Pfizer Inc.––diluted
0.82

 
0.25

 
0.06

 

 
0.18

 
1.30

See end of tables for notes (1) through (7).
Amounts may not add due to rounding.

- 17 -


PFIZER INC. AND SUBSIDIARY COMPANIES
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION(1) 
CERTAIN LINE ITEMS
(UNAUDITED)
(millions of dollars, except per common share data)

 
Second-Quarter 2015
 
GAAP Reported(2)
 
Purchase Accounting Adjustments
 
Acquisition-Related Costs(3)
 
Discontinued Operations
 
Certain Significant Items(4)
 
Non-GAAP Adjusted(5)
Revenues
$
11,853

 
$

 
$

 
$

 
$

 
$
11,853

Cost of sales(6), (7)
2,180

 
(1
)
 
(17
)
 

 
(39
)
 
2,123

Selling, informational and administrative expenses(6), (7)
3,386

 
1

 

 

 
(15
)
 
3,372

Research and development expenses(6), (7)
1,734

 
2

 

 

 
(4
)
 
1,732

Amortization of intangible assets(7)
872

 
(839
)
 

 

 

 
33

Restructuring charges and certain acquisition-related costs
86

 

 
(51
)
 

 
(35
)
 

Other (income)/deductions––net
55

 
3

 

 

 
(211
)
 
(153
)
Income from continuing operations before provision for taxes on income
3,539

 
835

 
68

 

 
305

 
4,747

Provision for taxes on income
905

 
238

 
18

 

 
52

 
1,213

Income from continuing operations
2,635

 
597

 
50

 

 
252

 
3,534

Discontinued operations––net of tax
1

 

 

 
(1
)
 

 

Net income attributable to noncontrolling interests
9

 

 

 

 

 
9

Net income attributable to Pfizer Inc.
2,626

 
597

 
50

 
(1
)
 
252

 
3,525

Earnings per common share attributable to Pfizer Inc.––diluted
0.42

 
0.10

 
0.01

 

 
0.04

 
0.56

 
Six Months Ended June 28, 2015
 
GAAP Reported(2)
 
Purchase Accounting Adjustments
 
Acquisition-Related Costs(3)
 
Discontinued Operations
 
Certain Significant Items(4)
 
Non-GAAP Adjusted(5)
Revenues
$
22,717

 
$

 
$

 
$

 
$

 
$
22,717

Cost of sales(6), (7)
4,018

 
(3
)
 
(26
)
 

 
(60
)
 
3,930

Selling, informational and administrative expenses(6), (7)
6,491

 
1

 

 

 
(43
)
 
6,449

Research and development expenses(6), (7)
3,620

 
3

 

 

 
(14
)
 
3,609

Amortization of intangible assets(7)
1,811

 
(1,745
)
 

 

 

 
67

Restructuring charges and certain acquisition-related costs
146

 

 
(65
)
 

 
(81
)
 

Other (income)/deductions––net
9

 
5

 

 

 
(335
)
 
(320
)
Income from continuing operations before provision for taxes on income
6,621

 
1,738

 
91

 

 
532

 
8,982

Provision for taxes on income
1,610

 
499

 
24

 

 
113

 
2,247

Income from continuing operations
5,011

 
1,239

 
67

 

 
419

 
6,736

Discontinued operations––net of tax
6

 

 

 
(6
)
 

 

Net income attributable to noncontrolling interests
14

 

 

 

 

 
14

Net income attributable to Pfizer Inc.
5,002

 
1,239

 
67

 
(6
)
 
419

 
6,721

Earnings per common share attributable to Pfizer Inc.––diluted
0.80

 
0.20

 
0.01

 

 
0.07

 
1.07

See end of tables for notes (1) through (7).
Amounts may not add due to rounding.

- 18 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS
(UNAUDITED)

(1)
Certain amounts in the reconciliation of GAAP reported to Non-GAAP adjusted information and associated notes may not add due to rounding.
(2)
The financial statements present the three and six months ended July 3, 2016 and June 28, 2015. Subsidiaries operating outside the U.S. are included for the three and six months ended May 29, 2016 and May 24, 2015.
The financial results of Hospira, Inc. (Hospira) are included in our consolidated financial statements commencing from the acquisition date of September 3, 2015. Therefore, our second-quarter and first six months of 2015 results of operations do not include Hospira's results of operations.
(3)
Acquisition-related costs include the following:
 
 
Second-Quarter
 
Six Months
(MILLIONS OF DOLLARS)
 
2016

 
2015

 
2016

 
2015

Restructuring charges(a)
 
$
26

 
$
8

 
$
30

 
$
5

Transaction costs(a)
 
36

 
1

 
60

 
6

Integration costs(a)
 
139

 
42

 
227

 
54

Additional depreciation––asset restructuring(b)
 

 
17

 

 
26

Total acquisition-related costs––pre-tax
 
202

 
68

 
317

 
91

Income taxes(c)
 
(73
)
 
(18
)
 
26

 
(24
)
Total acquisition-related costs––net of tax
 
$
129

 
$
50

 
$
344

 
$
67

(a)
Restructuring charges include employee termination costs, asset impairments and other exit costs associated with business combinations. In the second quarter and first six months of 2016, restructuring charges primarily relate to our acquisitions of Hospira in September 2015 and Anacor Pharmaceuticals, Inc. (Anacor) in June 2016. Transaction costs represent external costs for banking, legal, accounting and other similar services, most of which in the second quarter of 2016 are directly related to our acquisition of Anacor, and most of which in the first six months of 2016 are directly related to our acquisition of Anacor and the terminated transaction with Allergan plc (Allergan). Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. In the second quarter and first six months of 2016, integration costs primarily relate to our acquisition of Hospira and the terminated transaction with Allergan. Integration costs in 2015 represent external incremental costs directly related to our acquisition of Hospira. All of these costs and charges are included in Restructuring charges and certain acquisition-related costs.
(b)
Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions related to acquisitions. Included in Cost of sales for both the second quarter and first six months of 2015.
(c)
Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. The first six months of 2016 were unfavorably impacted by the remeasurement of certain deferred tax liabilities resulting from plant network restructuring activities.
(4)
Certain significant items include the following:
 
 
Second-Quarter
 
Six Months
(MILLIONS OF DOLLARS)
 
2016

 
2015

 
2016

 
2015

Restructuring charges(a)
 
$
114

 
$
35

 
$
140

 
$
81

Implementation costs and additional depreciation––asset restructuring(b)
 
117

 
56

 
228

 
114

Certain legal matters, net(c)
 
261

 
92

 
546

 
92

Certain asset impairments(d)
 
816

 

 
947

 

Business and legal entity alignment costs(e)
 
60

 
63

 
111

 
164

Other(f)
 
138

 
58

 
172

 
81

Total certain significant items––pre-tax
 
1,506

 
305

 
2,144

 
532

Income taxes(g)
 
(463
)
 
(52
)
 
(1,007
)
 
(113
)
Total certain significant items––net of tax
 
$
1,042

 
$
252

 
$
1,136

 
$
419

(a)
Relates to our cost-reduction and productivity initiatives not related to acquisitions. Included in Restructuring charges and certain acquisition-related costs.

- 19 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS
(UNAUDITED)

(b)
Relates to our cost-reduction and productivity initiatives not related to acquisitions. Virtually all included in Cost of sales ($90 million), Selling, informational and administrative expenses ($20 million) and Research and development expenses ($6 million) for second-quarter 2016. Virtually all included in Cost of sales ($180 million), Selling, informational and administrative expenses ($33 million) and Research and development expenses ($14 million) for the first six months of 2016. Virtually all included in Cost of sales ($39 million), Selling, informational and administrative expenses ($13 million) and Research and development expenses ($4 million) for second-quarter 2015. Virtually all included in Cost of sales ($61 million), Selling, informational and administrative expenses ($39 million) and Research and development expenses ($14 million) for the first six months of 2015.
(c)
Included in Other (income)/deductions––net. In the second quarter and first six months of 2016, primarily includes amounts to resolve a Multi-District Litigation relating to Celebrex and Bextra pending against the Company in New York federal court for $486 million, which is subject to the negotiation of a final settlement agreement and court approval, a portion of which was accrued for during the first quarter of 2016 and the full amount of which was accrued for during the first six months of 2016, partially offset by the reversal of a legal accrual where a loss is no longer deemed probable. In addition, the first six months of 2016 includes a settlement related to a patent matter.
(d)
Included in Other (income)/deductions––net. In the second quarter and first six months of 2016, primarily includes: (i) intangible asset impairment charges of $641 million, primarily related to developed technology rights for a generic injectable antibiotic product for the treatment of bacterial infections and an in-process research and development (IPR&D) compound for the treatment of anemia, both acquired in connection with our acquisition of Hospira; and (ii) impairment losses of $130 million in the second quarter of 2016 and $211 million in the first six months of 2016 related to Pfizer's 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. in China. The first six months of 2016 also includes an impairment loss of $50 million related to Pfizer's 40%-owned equity-method investment in Laboratório Teuto Brasileiro S.A.
(e)
Included in Other (income)/deductions––net. In the second quarter and first six months of 2016 and 2015, represents expenses for changes to our infrastructure to align our commercial operations, including costs to internally separate our businesses into distinct legal entities, as well as to streamline our intercompany supply operations to better support each business.
(f)
For the second quarter and first six months of 2016 and 2015, primarily all included in Other (income)/deductions––net. In the second quarter and first six months of 2016, primarily includes $150 million paid to Allergan for reimbursement of Allergan's expenses associated with the terminated transaction.
(g)
Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. The first six months of 2016 was favorably impacted by benefits related to the final resolution (pending court approval) of an agreement in principle reached in February 2016 to resolve certain claims related to Protonix, which resulted in the receipt of information that raised our assessment of the likelihood of prevailing on the technical merits of our tax position, as well as benefits associated with our Venezuela operations.
(5)
Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS. Despite the importance of these measures to management in goal setting and performance measurement (as described in the “Management's Discussion and Analysis of Financial Condition and Results of Operations––Non-GAAP Financial Measure (Adjusted Income)” section of Pfizer's Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2016), Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are Non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, have limits in their usefulness to investors. Because of their non-standardized definitions, Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS (unlike U.S. GAAP net income and its components and diluted EPS) may not be comparable to the calculation of similar measures of other companies. Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are presented solely to permit investors to more fully understand how management assesses performance.
(6)
Exclusive of amortization of intangible assets, except as discussed in footnote (7) below.
(7)
Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses and/or Research and development expenses, as appropriate.

- 20 -


PFIZER INC. AND SUBSIDIARY COMPANIES
OPERATING SEGMENT INFORMATION(1) 
(UNAUDITED)
(millions of dollars)

 
 
Second-Quarter 2016
 
 
Innovative Health (IH)(2)
 
Essential Health (EH)(2)
 
Other(2), (3)
 
Non-GAAP Adjusted(4)
 
Reconciling Items(5)
 
GAAP Reported
Revenues
 
$
7,105

 
$
6,042

 
$

 
$
13,147

 
$

 
$
13,147

Cost of sales
 
997

 
1,678

 
388

 
3,062

 
112

 
3,174

% of revenue
 
14.0
%
 
27.8
%
 
*

 
23.3
%
 
*

 
24.1
%
Selling, informational and administrative expenses
 
1,615

 
885

 
943

 
3,443

 
28

 
3,471

Research and development expenses
 
583

 
308

 
849

 
1,740

 
7

 
1,748

Amortization of intangible assets
 
24

 
7

 

 
31

 
930

 
961

Restructuring charges and certain acquisition-related costs
 

 

 

 

 
316

 
316

Other (income)/deductions––net
 
(292
)
 
(34
)
 
96

 
(230
)
 
1,298

 
1,068

Income from continuing operations before provision for taxes on income
 
4,179

 
3,198

 
(2,276
)
 
5,101

 
(2,691
)
 
2,410

 
 
 
Six Months Ended July 3, 2016
 
 
Innovative Health (IH)(2)
 
Essential Health (EH)(2)
 
Other(2), (3)
 
Non-GAAP Adjusted(4)
 
Reconciling Items(5)
 
GAAP Reported
Revenues
 
$
14,139

 
$
12,013

 
$

 
$
26,152

 
$

 
$
26,152

Cost of sales
 
1,891

 
3,131

 
605

 
5,627

 
399

 
6,026

% of revenue
 
13.4
%
 
26.1
%
 
*

 
21.5
%
 
*

 
23.0
%
Selling, informational and administrative expenses
 
3,300

 
1,622

 
1,889

 
6,811

 
44

 
6,856

Research and development expenses
 
1,145

 
584

 
1,734

 
3,463

 
15

 
3,478

Amortization of intangible assets
 
48

 
13

 

 
61

 
1,905

 
1,966

Restructuring charges and certain acquisition-related costs
 

 

 

 

 
457

 
457

Other (income)/deductions––net
 
(528
)
 
(194
)
 
342

 
(380
)
 
1,778

 
1,398

Income from continuing operations before provision for taxes on income
 
8,282

 
6,857

 
(4,570
)
 
10,569

 
(4,598
)
 
5,971

See end of tables for notes (1) through (5).
Amounts may not add due to rounding.
*
Calculation not meaningful.

- 21 -


PFIZER INC. AND SUBSIDIARY COMPANIES
OPERATING SEGMENT INFORMATION(1) 
(UNAUDITED)
(millions of dollars)

 
 
Second-Quarter 2015
 
 
Innovative Health (IH)(2)
 
Essential Heath (EH)(2)
 
Other(2), (3)
 
Non-GAAP Adjusted(4)
 
Reconciling Items(5)
 
GAAP Reported
Revenues
 
$
6,630

 
$
5,223

 
$

 
$
11,853

 
$

 
$
11,853

Cost of sales
 
937

 
1,042

 
144

 
2,123

 
58

 
2,180

% of revenue
 
14.1
%
 
19.9
%
 
*

 
17.9
%
 
*

 
18.4
%
Selling, informational and administrative expenses
 
1,619

 
840

 
913

 
3,372

 
15

 
3,386

Research and development expenses
 
573

 
219

 
941

 
1,732

 
2

 
1,734

Amortization of intangible assets
 
23

 
10

 

 
33

 
839

 
872

Restructuring charges and certain acquisition-related costs
 

 

 

 

 
86

 
86

Other (income)/deductions––net
 
(286
)
 
(31
)
 
164

 
(153
)
 
209

 
55

Income from continuing operations before provision for taxes on income
 
3,764

 
3,144

 
(2,161
)
 
4,747

 
(1,208
)
 
3,539

 
 
 
Six Months Ended June 28, 2015
 
 
Innovative Health (IH)(2)
 
Essential Health (EH)(2)
 
Other(2), (3)
 
Non-GAAP Adjusted(4)
 
Reconciling Items(5)
 
GAAP Reported
Revenues
 
$
12,368

 
$
10,348

 
$

 
$
22,717

 
$

 
$
22,717

Cost of sales
 
1,703

 
2,044

 
182

 
3,930

 
89

 
4,018

% of revenue
 
13.8
%
 
19.8
%
 
*

 
17.3
%
 
*

 
17.7
%
Selling, informational and administrative expenses
 
3,021

 
1,544

 
1,884

 
6,449

 
42

 
6,491

Research and development expenses
 
1,315

 
419

 
1,875

 
3,609

 
10

 
3,620

Amortization of intangible assets
 
47

 
20

 

 
67

 
1,745

 
1,811

Restructuring charges and certain acquisition-related costs
 

 

 

 

 
146

 
146

Other (income)/deductions––net
 
(531
)
 
(38
)
 
249

 
(320
)
 
329

 
9

Income from continuing operations before provision for taxes on income
 
6,813

 
6,359

 
(4,190
)
 
8,982

 
(2,361
)
 
6,621

See end of tables for notes (1) through (5).
Amounts may not add due to rounding.
*
Calculation not meaningful.


- 22 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO OPERATING SEGMENT INFORMATION
(UNAUDITED)


(1)
Certain amounts in the operating segment information and associated notes may not add due to rounding.
(2)
Amounts represent the revenues and costs managed by each of our business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). The expenses generally include only those costs directly attributable to the segment. Effective in the second quarter of 2016, our segments were reorganized to reflect that we now manage our innovative pharmaceutical and consumer healthcare operations as one business segment, Pfizer Innovative Health (previously these businesses were managed as two segments: the Global Innovative Pharmaceutical segment and the Global Vaccines, Oncology and Consumer Healthcare segment). Also, in the second quarter of 2016, we changed the name of our Established Products business to Pfizer Essential Health. We have revised prior-period segment information to reflect the reorganization.
Hospira's commercial operations are included in EH's operating results in our consolidated statement of income, commencing from the acquisition date of September 3, 2015. Therefore, our results of operations and EH's operating results for the second quarter and first six months of 2015 do not include Hospira's results of operations.
Some additional information about our business segments follows:
Pfizer Innovative Health (IH) Segment
Pfizer Essential Health (EH) Segment
IH focuses on developing and commercializing novel, value-creating medicines and vaccines that significantly improve patients’ lives, as well as products for consumer healthcare. Key therapeutic areas include vaccines, oncology, inflammation/immunology, cardiovascular/metabolic, neuroscience/pain, rare diseases and consumer healthcare and include leading brands, such as Prevnar/Prevenar 13, Xeljanz, Eliquis, Lyrica (U.S., Japan and certain other markets), Enbrel (outside the U.S. and Canada) and Viagra (U.S. and Canada), as well as several well-known, over-the-counter (OTC) consumer products.
 
EH 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. EH also includes a new EH research and development organization as well as our contract manufacturing business.
Effective as of the beginning of 2016, the following changes impact EH:
Our entire contract manufacturing business, Pfizer CentreOne, is part of EH. Pfizer CentreOne consists of (i) the revenues and expenses of legacy Pfizer's contract manufacturing and active pharmaceutical ingredient sales operation, including the revenues and expenses related to our manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) the revenues and expenses of legacy Hospira's One-2-One sterile injectables contract manufacturing operation, which has been included in EH since we acquired Hospira on September 3, 2015. Prior to 2016, PCS was managed outside our operating segments as part of Pfizer Global Supply and reported as "Other Business Activities". We have reclassified prior period PCS operating results ($133 million of PCS revenues and $30 million of PCS earnings in the second quarter of 2015, and $244 million of PCS revenues and $52 million of PCS earnings in the first six months of 2015) to conform to the current period presentation as part of EH.
In connection with the formation of a new EH Research and Development (R&D) organization, certain functions transferred from Pfizer’s Worldwide Research and Development (WRD) organization to the new EH R&D organization. The new R&D organization within EH expects to develop potential new sterile injectable drugs and therapeutic solutions, as well as biosimilars. We have reclassified approximately $67 million of costs in the second quarter of 2015 and $134 million of costs in the first six months of 2015 from WRD to EH to conform to the current period presentation as part of EH.
Effective as of the beginning of the second quarter of 2016, the following changes impact IH:
In connection with the formation of the Global Product Development (GPD) organization, a new unified center for late-stage development for our innovative products, which is generally responsible for the clinical development of assets that have achieved proof-of-concept across our innovative portfolio, certain development-related functions transferred from IH to GPD. We have reclassified approximately $76 million of costs in the first quarter of 2016, approximately $73 million of costs in the second quarter of 2015 and approximately $147 million of costs in the first six months of 2015 from IH to GPD to conform to the current period presentation as part of GPD.


- 23 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO OPERATING SEGMENT INFORMATION
(UNAUDITED)


The second quarter of 2016 reflects the following, as compared to the second quarter of 2015:
IH––The slight decrease in Cost of sales as a percentage of Revenues was primarily driven by a favorable change in product mix, including an increase in alliance revenues, which have no associated cost of sales, partially offset by unfavorable foreign exchange. The increase in Cost of sales was primarily driven by unfavorable foreign exchange and an increase in royalty expense, partially offset by favorable product mix. The slight decrease in Selling, informational and administrative expenses reflects favorable foreign exchange, offset by additional investment in Prevnar 13 and Eliquis. The increase in Research and development expenses primarily reflects the increased costs associated with our avelumab alliance with Merck KGaA.
EH––The increase in Cost of sales as a percentage of Revenues was primarily due to the inclusion of legacy Hospira operations, unfavorable foreign exchange and the impact of losses of exclusivity resulting in an unfavorable change in product mix. The increase in Cost of sales was driven by the inclusion of legacy Hospira operations and the unfavorable impact from foreign exchange, partially offset by lower volumes as a result of products losing exclusivity. The increase in Selling, informational and administrative expenses was primarily due to the inclusion of legacy Hospira operations, partially offset by lower advertising, promotional and field force expenses, reflecting the benefits of cost-reduction and productivity initiatives, and favorable foreign exchange. Research and development expenses increased, reflecting the inclusion of legacy Hospira operations and increased investment in legacy Pfizer biosimilar development programs.
The first six months of 2016 reflects the following, as compared to the first six months of 2015:
IH––The slight decrease in Cost of sales as a percentage of Revenues was primarily driven by a favorable change in product mix, including an increase in alliance revenues, which have no associated cost of sales, partially offset by unfavorable foreign exchange. The increase in Cost of sales was primarily driven by unfavorable foreign exchange, an increase in sales volumes and an increase in royalty expense. The increase in Selling, informational and administrative expenses reflects an increase in the allowance for doubtful trade accounts receivable, resulting from unfavorable developments with a distributor, and additional investment in Eliquis and Prevnar 13, partially offset by favorable foreign exchange. The decrease in Research and development expenses primarily reflects the non-recurrence of the $295 million upfront payment made to OPKO Health Inc. in the first quarter of 2015, partially offset by increased costs associated with our oncology programs, primarily our avelumab alliance with Merck KGaA and increased investment in certain late-stage pipeline programs, primarily bococizumab and tanezumab.
EH––The increase in Cost of sales as a percentage of Revenues was primarily due to the inclusion of legacy Hospira operations, unfavorable foreign exchange and the impact of losses of exclusivity resulting in an unfavorable change in product mix. The increase in Cost of sales was driven by the inclusion of legacy Hospira operations and the unfavorable impact from foreign exchange, partially offset by lower volumes as a result of products losing exclusivity. The increase in Selling, informational and administrative expenses was primarily due to the inclusion of legacy Hospira operations, partially offset by favorable foreign exchange and lower advertising, promotional and field force expenses, reflecting the benefits of cost-reduction and productivity initiatives. Research and development expenses increased, reflecting the inclusion of legacy Hospira operations and increased investment in legacy Pfizer biosimilar development programs. The favorable change in Other (income)/deductions––net primarily reflects resolution of a contract disagreement and favorable foreign exchange.

- 24 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO OPERATING SEGMENT INFORMATION
(UNAUDITED)


(3)
Other comprises the revenues and costs included in our Adjusted income components(4) that are managed outside of our two operating segments and includes the following:
 
 
Second-Quarter 2016
 
 
Other Business Activities
 
 
 
 
 
 
(IN MILLIONS)
 
WRD(a)
 
GPD(b)
 
Medical(c)
 
Corporate(d)
 
Other Unallocated(e)
 
Total
Revenues
 
$

 
$

 
$

 
$

 
$

 
$

Cost of sales
 

 

 

 
51

 
337

 
388

Selling, informational and administrative expenses
 

 

 
34

 
876

 
33

 
943

Research and development expenses
 
527

 
161

 

 
156

 
6

 
849

Amortization of intangible assets
 

 

 

 

 

 

Restructuring charges and certain acquisition-related costs
 

 

 

 

 

 

Other (income)/deductions––net
 
(13
)
 

 

 
173

 
(64
)
 
96

Loss from continuing operations before provision for taxes on income
 
$
(514
)
 
$
(161
)
 
$
(34
)
 
$
(1,256
)
 
$
(312
)
 
$
(2,276
)
 
 
Six Months Ended July 3, 2016
 
 
Other Business Activities
 
 
 
 
 
 
(IN MILLIONS)
 
WRD(a)
 
GPD(b)
 
Medical(c)
 
Corporate(d)
 
Other
Unallocated
(e)
 
Total
Revenues
 
$

 
$

 
$

 
$

 
$

 
$

Cost of sales
 

 

 

 
91

 
514

 
605

Selling, informational and administrative expenses
 

 

 
61

 
1,776

 
52

 
1,889

Research and development expenses
 
1,054

 
315

 

 
354

 
11

 
1,734

Amortization of intangible assets
 

 

 

 

 

 

Restructuring charges and certain acquisition-related costs
 

 

 

 

 

 

Other (income)/deductions––net
 
(27
)
 

 

 
399

 
(29
)
 
342

Loss from continuing operations before provision for taxes on income
 
$
(1,028
)
 
$
(315
)
 
$
(61
)
 
$
(2,619
)
 
$
(548
)
 
$
(4,570
)
 
 
Second-Quarter 2015
 
 
Other Business Activities
 
 
 
 
 
 
(IN MILLIONS)
 
WRD(a)
 
GPD(b)
 
Medical(c)
 
Corporate(d)
 
Other Unallocated(e)
 
Total
Revenues
 
$

 
$

 
$

 
$

 
$

 
$

Cost of sales
 

 

 

 
25

 
118

 
144

Selling, informational and administrative expenses
 

 

 
28

 
871

 
14

 
913

Research and development expenses
 
544

 
150

 
7

 
231

 
9

 
941

Amortization of intangible assets
 

 

 

 

 

 

Restructuring charges and certain acquisition-related costs
 

 

 

 

 

 

Other (income)/deductions––net
 
(15
)
 

 

 
159

 
19

 
164

Loss from continuing operations before provision for taxes on income
 
$
(530
)
 
$
(150
)
 
$
(35
)
 
$
(1,286
)
 
$
(160
)
 
$
(2,161
)


- 25 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO OPERATING SEGMENT INFORMATION
(UNAUDITED)


 
 
Six Months Ended June 28, 2015
 
 
Other Business Activities
 
 
 
 
 
 
(IN MILLIONS)
 
WRD(a)
 
GPD(b)
 
Medical(c)
 
Corporate(d)
 
Other Unallocated(e)
 
Total
Revenues
 
$

 
$

 
$

 
$

 
$

 
$

Cost of sales
 

 

 

 
48

 
134

 
182

Selling, informational and administrative expenses
 

 

 
54

 
1,807

 
23

 
1,884

Research and development expenses
 
1,085

 
304

 
13

 
460

 
13

 
1,875

Amortization of intangible assets
 

 

 

 

 

 

Restructuring charges and certain acquisition-related costs
 

 

 

 

 

 

Other (income)/deductions––net
 
(44
)
 

 

 
257

 
36

 
249

Loss from continuing operations before provision for taxes on income
 
$
(1,042
)
 
$
(304
)
 
$
(66
)
 
$
(2,573
)
 
$
(205
)
 
$
(4,190
)
(a)
WRD––the research and development expenses managed by our WRD organization, which is generally responsible for research projects for our Innovative Health business until proof-of-concept is achieved and then for transitioning those projects to the IH segment via the newly formed GPD organization for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. The WRD organization also has responsibility for certain science-based and other platform-services organizations, which provide technical expertise and other services to the various R&D projects, including EH R&D projects. WRD is also responsible for facilitating all regulatory submissions and interactions with regulatory agencies, including all safety-event activities. As noted above, in connection with the formation of the new EH R&D organization, certain functions transferred from WRD to the new EH R&D organization. We have reclassified approximately $67 million of costs in the second quarter of 2015 and $134 million in the first six months of 2015 from WRD to EH to conform to the current period presentation as part of EH. Also, in connection with the formation of the new GPD organization, beginning in the second quarter of 2016, certain development-related functions transferred from WRD to GPD. See note (b) below for additional information.
(b)
GPD––the costs associated with our newly formed GPD organization, which is generally responsible for the clinical development of assets that have achieved proof-of-concept across our innovative portfolio. GPD also provides technical support and other services to Pfizer R&D projects. In connection with the formation of the GPD organization, certain development-related functions transferred from WRD and IH to GPD. We have reclassified costs of approximately $78 million from WRD and $76 million from IH in the first quarter of 2016, approximately $77 million from WRD and $73 million from IH in the second quarter of 2015 and approximately $157 million from WRD and $147 million from IH in the first six months of 2015 to GPD to conform to the current period presentation as part of GPD.
(c)
Medical––the costs associated with our Pfizer Medical organization (Medical), which is responsible for the provision of medical information to healthcare providers, patients and other parties, transparency and disclosure activities, clinical trial results publication, grants for healthcare quality improvement and medical education, and partnerships with global public health and medical associations.
(d)
Corporate––the costs associated with Corporate, representing platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement) and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments.
(e)
Other Unallocated––other unallocated costs, representing overhead expenses associated with our manufacturing and commercial operations not directly attributable to an operating segment.
Although we typically provide qualitative information about our Other costs on an annual basis, updated estimates are provided in the first six months of 2016, reflecting: (i) the reorganization of our IH business; (ii) the transfer of certain WRD functions to EH; and (iii) the transfer of certain development-related functions from WRD and IH to GPD. For information purposes only, for the first six months of 2016, we estimate that Other costs, in the aggregate and as described above, but excluding (i) net interest-related expense not attributable to an operating segment included in Corporate (approximately $415 million for the first six months of 2016 in Other (income)/deductions––net); and (ii) net income from investments not attributable to an operating segment and included in Corporate (approximately $49 million for the first six months of 2016 in Other (income)/deductions––net), are generally associated with our operating segments, as follows:

- 26 -


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO OPERATING SEGMENT INFORMATION
(UNAUDITED)


Six Months Ended July 3, 2016
(PERCENTAGES)
 
IH
 
EH
Total WRD/GPD/Medical costs
 
96% - 98%
 
2% - 4%
Total Corporate/Other Unallocated costs
 
49% - 51%
 
49% - 51%
Total WRD/GPD/Medical and Corporate/Other Unallocated costs
 
65% - 67%
 
33% - 35%
Total WRD/GPD/Medical and Corporate/Other Unallocated costs, by line item:
 
 
 
 
Cost of sales
 
24% - 26%
 
74% - 76%
Selling, informational and administrative expenses
 
50% - 52%
 
48% - 50%
Research and development expenses
 
95% - 97%
 
3% - 5%
Other (income)/deductions––net
 
*
 
*
*
Amounts not material. After excluding net interest expense included in Corporate and net income on investments not attributable to an operating segment and included in Corporate, Other (income)/deductions––net approximates $24 million of income for the first six months of 2016.
The percentages provided in the table above do not purport to reflect additional amounts that each of our operating segments would have incurred had each segment operated as a standalone company during the period presented.
WRD/GPD/Medical––The information provided in the table above for WRD, GPD and Medical was substantially all derived from our estimates of the costs incurred in connection with the R&D projects associated with each operating segment.
Corporate/Other Unallocated––The information provided in the table above for Corporate and Other Unallocated was derived mainly using proportional allocation methods based on global, regional or country revenues or global, regional or country headcount, as well as certain cost metrics, as appropriate, such as those derived from research and development and manufacturing costs, and, to a lesser extent, specific identification. Management believes that the allocations of Corporate and Other Unallocated costs are reasonable.
(4)
These “Adjusted Income” components are defined as the corresponding reported U.S. GAAP components, excluding purchase accounting adjustments, acquisition-related costs and certain significant items (some of which may recur, such as restructuring or legal charges, but which management does not believe are reflective of our ongoing core operations). Adjusted Cost of Sales, Adjusted Selling, Informational and Administrative (SI&A) expenses, Adjusted Research and Development (R&D) expenses, Adjusted Amortization of Intangible Assets and Adjusted Other (Income)/Deductions––Net are income statement line items prepared on the same basis as, and therefore components of, the overall adjusted income measure. As described in the “Management's Discussion and Analysis of Financial Condition and Results of Operations––Non-GAAP Financial Measure (Adjusted Income)” section of Pfizer's Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2016, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income and certain components of Adjusted income in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines, vaccines, medical devices and consumer healthcare (OTC) products––prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the second quarter and first six months of 2016 and 2015. The Adjusted income component measures are not, and should not be viewed as, substitutes for the U.S. GAAP component measures.
(5)
Includes costs associated with (i) purchase accounting adjustments; (ii) acquisition-related costs; and (iii) certain significant items, which are substantive and in some cases recurring (such as restructuring or legal charges), or unusual items that are evaluated on an individual basis by management. For additional information about these reconciling items and/or our non-GAAP adjusted measure of performance, see the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the second quarter and first six months of 2016 and 2015

- 27 -

PFIZER INC. - REVENUES
SECOND-QUARTER 2016 and 2015
(UNAUDITED)

 
 
WORLDWIDE
UNITED STATES
TOTAL INTERNATIONAL(a)
 
 
2016
2015
% Change
2016
2015
% Change
2016
2015
% Change
(MILLIONS OF DOLLARS)
 
Total
Oper.
Total
Total
Oper.
TOTAL REVENUES
 
$
13,147

$
11,853

11%
13%
$
6,335

$
4,994

27%
$
6,812

$
6,859

(1%)
4%
PFIZER INNOVATIVE HEALTH (IH)(b)
 
$
7,105

$
6,630

7%
9%
$
3,950

$
3,459

14%
$
3,156

$
3,170

3%
Internal Medicine
 
$
2,190

$
1,895

16%
16%
$
1,577

$
1,430

10%
$
613

$
465

32%
33%
Lyrica IH(c)
 
1,048

907

15%
16%
788

651

21%
260

257

1%
3%
Viagra IH(d)
 
300

334

(10%)
(10%)
292

326

(10%)
8

8

(5%)
Chantix/Champix
 
213

173

23%
24%
148

106

40%
65

68

(4%)
(1%)
Toviaz
 
67

71

(5%)
(6%)
24

33

(27%)
43

38

15%
12%
BMP2
 
61

75

(19%)
(19%)
61

75

(19%)


Alliance revenues(e)
 
371

291

28%
25%
221

206

7%
150

84

78%
70%
All other Internal Medicine
 
130

44

*
*
43

34

26%
87

10

*
*
Vaccines
 
$
1,365

$
1,580

(14%)
(13%)
$
792

$
882

(10)%
$
573

$
698

(18%)
(16%)
Prevnar/Prevenar 13
 
1,258

1,503

(16%)
(15%)
768

880

(13%)
490

622

(21%)
(19%)
FSME/IMMUN-TicoVac
 
42

56

(24)%
(26)%


42

56

(24%)
(26%)
All other Vaccines
 
65

21

*
*
24

2

*
41

20

*
*
Oncology
 
$
1,101

$
713

54%
56%
$
755

$
388

94%
$
345

325

6%
9%
Ibrance
 
514

140

*
*
502

140

*
12


*
*
Sutent
 
285

294

(3%)
107

98

9%
178

195

(9%)
(5%)
Xalkori
 
137

119

15%
15%
62

60

3%
75

58

28%
28%
Inlyta
 
108

111

(2%)
(3%)
45

54

(17%)
63

57

11%
11%
All other Oncology
 
57

49

16%
15%
39

35

9%
18

14

32%
29%
Inflammation & Immunology (I&I)
 
$
999

$
966

3%
7%
$
189

$
116

63%
$
810

$
850

(5%)
(1%)
Enbrel (Outside the U.S. and Canada)
 
766

822

(7%)
(3%)


766

822

(7%)
(3%)
Xeljanz
 
217

128

70%
72%
189

116

63%
28

12

*
*
All other I&I
 
16

16

1%
(7%)


16

16

1%
(7%)
Rare Disease
 
$
614

$
636

(3%)
(2%)
$
196

$
220

(11%)
$
418

$
416

1%
3%
BeneFIX
 
183

193

(5%)
(5%)
79

87

(9%)
104

106

(2%)
(1%)
Genotropin
 
152

167

(9%)
(6%)
37

50

(25%)
115

117

(2%)
2%
Refacto AF/Xyntha
 
139

142

(2%)
(1%)
32

35

(8%)
107

106

2%
Somavert
 
59

55

8%
8%
20

17

18%
39

38

3%
3%
Rapamune
 
47

53

(11%)
(4%)
21

27

(21%)
26

26

(1%)
14%
All other Rare Disease
 
33

26

27%
23%
6

4

42%
28

22

24%
20%
Consumer Healthcare
 
$
837

$
840

5%
$
441

$
423

4%
$
395

$
417

(5%)
6%
PFIZER ESSENTIAL HEALTH (EH)(f)
 
$
6,042

$
5,223

16%
19%
$
2,385

$
1,535

55%
$
3,656

$
3,688

(1%)
4%
Legacy Established Products (LEP)(g)
 
$
2,864

$
2,934

(2%)
2%
$
971

$
880

10%
$
1,894

$
2,054

(8%)
(1%)
Lipitor
 
461

509

(9%)
(2%)
44

40

11%
417

469

(11%)
(3%)
Premarin family
 
251

259

(3%)
(2%)
236

242

(2%)
15

17

(14%)
(4%)
Norvasc
 
240

251

(4%)
(2%)
10

9

11%
230

242

(5%)
(2%)
EpiPen
 
93

85

9%
10%
79

70

13%
14

15

(7%)
(5%)
Xalatan/Xalacom
 
94

99

(5%)
(4%)
6

5

25%
88

94

(7%)
(6%)
Relpax
 
87

82

6%
5%
63

57

10%
24

25

(4%)
(6%)
Zoloft
 
77

93

(17%)
(14%)
16

17

(7%)
61

76

(19%)
(15%)
Zithromax/Zmax(h)
 
67

61

10%
12%
1

(2
)
*
66

63

5%
7%
Effexor
 
67

74

(9%)
(5%)
20

27

(25%)
47

47

1%
6%
Tikosyn
 
55

42

32%
32%
55

42

32%


Xanax/Xanax XR
 
55

54

2%
3%
12

11

10%
44

44

1%
Cardura
 
48

55

(11%)
(10%)
1

1

60%
47

54

(13%)
(11%)
Neurontin
 
47

48

(2%)
5%
12

12

6%
35

36

(5%)
5%
Depo-Provera
 
34

51

(33%)
(31%)
13

17

(24%)
21

34

(38%)
(34%)
All other LEP
 
1,187

1,172

1%
8%
402

333

21%
785

839

(6%)
2%
Sterile Injectable Pharmaceuticals (SIP)(i)
 
$
1,497

$
751

99%
*
$
837

$
282

*
$
660

$
469

41%
47%
Medrol(h)
 
115

99

16%
21%
71

54

31%
44

45

(3%)
8%
Sulperazon
 
105

80

31%
37%


105

80

31%
37%
Fragmin
 
82

88

(7%)
(4%)
8

8

74

80

(8%)
(5%)
Tygacil
 
59

77

(23%)
(17%)
11

28

(61%)
48

49

(2%)
7%
All other SIP
 
1,136

407

*
*
747

192

*
389

215

81%
87%
Peri-LOE Products(j)
 
$
1,111

$
1,406

(21%)
(19%)
$
251

$
316

(20%)
$
860

$
1,090

(21%)
(19%)
Lyrica EH(c)
 
214

312

(31%)
(31%)


214

312

(31%)
(31%)
Pristiq
 
194

177

10%
11%
157

137

14%
37

40

(6%)
1%
Celebrex
 
183

224

(18%)
(16%)
30

58

(48%)
153

166

(8%)
(5%)
Vfend
 
162

162

2%
12

7

69%
151

156

(3%)
(1%)
Zyvox
 
114

259

(56%)
(54%)
19

87

(79%)
95

172

(45%)
(41%)
Viagra EH(d)
 
101

113

(11%)
(6%)


101

113

(11%)
(6%)
Revatio
 
74

65

14%
13%
25

19

30%
49

46

7%
6%
All other Peri-LOE Products
 
69

94

(26%)
(24%)
9

7

21%
61

86

(30%)
(28%)
Infusion Systems(k)
 
$
295

$

*
*
$
230

$

*
$
65

$

*
*
Biosimilars(l)
 
$
78

$

*
*
$

$

$
78

$

*
*
Pfizer CentreOne(m)
 
$
196

$
133

47%
48%
$
96

$
58

66%
$
100

$
75

33%
31%
Total Lyrica(c)
 
$
1,261

$
1,219

3%
4%
$
788

$
651

21%
$
473

$
568

(17%)
(16%)
Total Viagra(d)
 
$
401

$
448

(11%)
(9%)
$
292

$
326

(10%)
$
109

$
122

(11%)
(5%)
Total Alliance revenues
 
$
376

$
311

21%
19%
$
223

$
212

5%
$
154

$
99

56%
49%
See end of tables for notes.

- 28 -

PFIZER INC.
INTERNATIONAL REVENUES BY GEOGRAPHIC REGION
SECOND-QUARTER 2016 and 2015
(UNAUDITED)


 
 
DEVELOPED EUROPE(n)
DEVELOPED REST OF WORLD(o)
EMERGING MARKETS(p)
 
 
2016
2015
% Change
2016
2015
% Change
2016
2015
% Change
(MILLIONS OF DOLLARS)
 
Total
Oper.
Total
Oper.
Total
Oper.
TOTAL INTERNATIONAL REVENUES
 
$
2,440

$
2,380

3%
1%
$
1,718

$
1,558

10%
7%
$
2,655

$
2,921

(9%)
4%
PFIZER INNOVATIVE HEALTH (IH)(b)
 
$
1,371

$
1,303

5%
4%
$
853

$
750

14%
10%
$
932

$
1,117

(17%)
(2%)
Internal Medicine
 
$
129

$
42

*
*
$
359

$
295

22%
16%
$
125

$
128

(2%)
14%
Lyrica IH(c)
 


204

179

14%
8%
56

78

(28%)
(9%)
Viagra IH(d)
 


8

8

(5%)


Chantix/Champix
 
20

20

37

32

13%
14%
8

15

(45%)
(33%)
Toviaz
 
18

17

3%
2%
22

17

27%
21%
3

3

11%
17%
BMP2
 






Alliance revenues(q)
 
90

47

91%
87%
61

36

72%
64%
(1
)
1

*
*
All other Internal Medicine
 
1

(43
)
*
*
27

23

19%
13%
59

31

91%
*
Vaccines
 
$
210

$
222

(5%)
(7%)
$
108

$
105

4%
2%
$
254

$
371

(31%)
(26%)
Prevnar/Prevenar 13
 
145

159

(9%)
(11%)
107

104

3%
1%
238

358

(34%)
(29%)
FSME/IMMUN-TicoVac
 
32

44

(26%)
(28%)


10

12

(18%)
(20%)
All other Vaccines
 
33

19

72%
71%
1


*
*
7

1

*
*
Oncology
 
$
156

$
157

(1%)
(2%)
$
80

$
65

23%
18%
$
109

$
102

7%
21%
Ibrance
 
3


*
*


9


*
*
Sutent
 
83

93

(11%)
(12%)
31

30

6%
3%
64

73

(12%)
1%
Xalkori
 
36

29

22%
20%
15

10

55%
52%
24

19

21%
29%
Inlyta
 
27

28

(4%)
(5%)
26

21

21%
12%
10

7

40%
65%
All other Oncology
 
8

7

8%
5%
8

5

72%
61%
3

2

25%
42%
Inflammation & Immunology (I&I)
 
$
509

$
526

(3%)
(4%)
$
135

$
127

6%
2%
$
166

$
198

(16%)
6%
Enbrel (Outside Canada)
 
504

523

(4%)
(5%)
105

106

(1%)
(5%)
157

193

(19%)
2%
Xeljanz
 
5

3

95%
99%
13

4

*
*
9

5

96%
*
All other I&I
 


16

16

(7%)


Rare Disease
 
$
248

$
249

(1%)
$
103

$
96

8%
5%
$
67

$
71

(6%)
15%
BeneFIX
 
64

64

1%
1%
30

31

(4%)
(4%)
9

11

(16%)
(6%)
Genotropin
 
47

51

(8%)
(9%)
44

39

11%
5%
24

26

(11%)
18%
Refacto AF/Xyntha
 
80

80

12

11

8%
14%
14

15

(5%)
4%
Somavert
 
31

30

3%
4

4

20%
18%
3

4

(8%)
10%
Rapamune
 
10

10

(1%)
(2%)
3

4

(7%)
(3%)
12

12

1%
32%
All other Rare Disease
 
15

13

10%
7%
9

7

41%
31%
4

2

51%
57%
Consumer Healthcare
 
$
118

$
107

10%
8%
$
67

$
63

7%
13%
$
210

$
247

(15%)
4%
PFIZER ESSENTIAL HEALTH (EH)(f)
 
$
1,069

$
1,077

(1%)
(2%)
$
865

$
808

7%
4%
$
1,722

$
1,803

(5%)
8%
Legacy Established Products (LEP)(g)
 
$
393

$
380

4%
2%
$
515

$
533

(3%)
(7%)
$
985

$
1,142

(14%)
Lipitor
 
47

54

(13%)
(14%)
61

65

(7%)
(6%)
309

350

(12%)
(1%)
Premarin family
 
1

2

(27%)
(24%)
7

7

3%
7

9

(22%)
(5%)
Norvasc
 
18

18

(3%)
(5%)
65

69

(6%)
(10%)
147

154

(5%)
1%
EpiPen
 


14

15

(7%)
(5%)


Xalatan/Xalacom
 
19

23

(18%)
(19%)
41

41

1%
(5%)
28

30

(8%)
3%
Relpax
 
9

12

(28%)
(30%)
11

10

16%
9%
4

3

28%
37%
Zoloft
 
9

8

9%
8%
24

40

(40%)
(44%)
28

28

2%
19%
Zithromax/Zmax(h)
 
11

9

19%
16%
14

14

(3%)
(10%)
42

40

5%
11%
Effexor
 
16

16

3%
1%
12

8

40%
40%
19

22

(15%)
(3%)
Tikosyn
 






Xanax/Xanax XR
 
21

20

7%
4%
5

6

(7%)
(12%)
17

18

(6%)
3%
Cardura
 
13

16

(20%)
(22%)
13

14

(6%)
(12%)
21

23

(11%)
(3%)
Neurontin
 
12

11

3%
4%
8

8

1%
15

17

(12%)
7%
Depo-Provera
 
5

6

(13%)
(11%)
3

3

1%
6%
13

25

(48%)
(44%)
All other LEP
 
212

184

16%
14%
237

233

2%
(3%)
336

422

(20%)
Sterile Injectable Pharmaceuticals (SIP)(i)
 
$
174

$
133

31%
30%
$
135

$
73

84%
83%
$
351

$
263

34%
46%
Medrol(h)
 
14

15

(5%)
(5%)
6

6

(1%)
(2%)
23

24

(2%)
18%
Sulperazon
 


4

4

(10%)
(17%)
102

76

33%
40%
Fragmin
 
42

46

(7%)
(6%)
18

21

(13%)
(9%)
14

14

5%
Tygacil
 
18

13

35%
33%
2

2

(1%)
5%
28

34

(16%)
(2%)
All other SIP
 
100

59

69%
67%
106

41

*
*
183

115

60%
74%
Peri-LOE Products(j)
 
$
356

$
517

(31%)
(32%)
$
178

$
193

(8%)
(12%)
$
326

$
380

(14%)
(5%)
Lyrica EH(c)
 
186

274

(32%)
(32%)


27

37

(27%)
(21%)
Pristiq
 
5

4

26%
23%
18

22

(20%)
(16%)
14

13

5%
22%
Celebrex
 
8

11

(26%)
(27%)
69

73

(5%)
(10%)
76

82

(8%)
2%
Vfend
 
62

67

(6%)
(8%)
33

30

11%
5%
56

59

(6%)
3%
Zyvox
 
28

80

(65%)
(66%)
21

24

(15%)
(20%)
47

68

(31%)
(20%)
Viagra EH(d)
 
12

13

(13%)
(13%)
9

10

(11%)
(12%)
80

90

(11%)
(4%)
Revatio
 
32

29

7%
6%
9

9

(7%)
8

7

18%
27%
All other Peri-LOE Products
 
22

38

(42%)
(43%)
20

25

(22%)
(26%)
19

23

(19%)
(4%)
Infusion Systems(k)
 
$
14

$

*
*
$
23

$

*
*
$
27

$

*
*
Biosimilars(l)
 
$
70

$

*
*
$
1

$

*
*
$
7

$

*
*
Pfizer CentreOne(m)
 
$
62

$
47

33%
30%
$
12

$
9

33%
30%
$
26

$
19

33%
32%
Total Lyrica(c)
 
$
186

$
274

(32%)
(32%)
$
204

$
179

14%
8%
$
83

$
115

(28%)
(13%)
Total Viagra(d)
 
$
12

$
13

(13%)
(13%)
$
17

$
18

(8%)
(6%)
$
80

$
90

(11%)
(4%)
Total Alliance revenues
 
$
93

$
57

62%
58%
$
62

$
37

65%
57%
$
(1
)
$
4

*
*
See end of tables for notes.

- 29 -

PFIZER INC. - REVENUES
SIX MONTHS 2016 and 2015
(UNAUDITED)


 
 
WORLDWIDE
UNITED STATES
TOTAL INTERNATIONAL(a)
 
 
2016
2015
% Change
2016
2015
% Change
2016
2015
% Change
(MILLIONS OF DOLLARS)
 
Total
Oper.
Total
Total
Oper.
TOTAL REVENUES
 
$
26,152

$
22,717

15%
20%
$
12,960

$
9,428

37%
$
13,192

$
13,289

(1%)
7%
PFIZER INNOVATIVE HEALTH (IH)(b)
 
$
14,139

$
12,368

14%
18%
$
8,064

$
6,431

25%
$
6,075

$
5,937

2%
10%
Internal Medicine
 
$
4,314

$
3,546

22%
23%
$
3,153

$
2,666

18%
$
1,161

$
880

32%
38%
Lyrica IH(c)
 
2,059

1,753

17%
19%
1,570

1,272

23%
488

482

1%
8%
Viagra IH(d)
 
600

622

(4%)
(3%)
584

605

(3%)
16

17

(9%)
1%
Chantix/Champix
 
434

332

31%
33%
307

203

51%
126

129

(2%)
5%
Toviaz
 
131

134

(2%)
(1%)
50

62

(20%)
81

72

13%
14%
BMP2
 
112

113

(1%)
(1%)
112

113

(1%)


Alliance revenues(e)
 
722

498

45%
45%
449

347

30%
273

152

80%
82%
All other Internal Medicine
 
257

94

*
*
80

65

24%
177

29

*
*
Vaccines
 
$
2,935

$
2,908

1%
3%
$
1,833

$
1,730

6%
$
1,102

$
1,178

(6%)
(2%)
Prevnar/Prevenar 13
 
2,766

2,808

(1%)
1,799

1,727

4%
967

1,081

(11%)
(5%)
FSME/IMMUN-TicoVac
 
69

65

6%
6%


69

65

6%
6%
All other Vaccines
 
100

34

*
*
34

3

*
66

31

*
*
Oncology
 
$
2,102

$
1,240

69%
72%
$
1,423

$
619

*
$
679

$
621

9%
15%
Ibrance
 
942

178

*
*
924

178

*
18


*
*
Sutent
 
563

536

5%
10%
209

171

22%
354

365

(3%)
4%
Xalkori
 
275

230

20%
22%
124

110

13%
151

121

25%
30%
Inlyta
 
209

206

1%
3%
89

98

(9%)
120

108

11%
15%
All other Oncology
 
112

90

25%
26%
77

63

23%
35

27

30%
34%
Inflammation & Immunology (I&I)
 
$
1,947

$
1,829

6%
14%
$
367

$
197

86%
$
1,580

$
1,632

(3%)
5%
Enbrel (Outside the U.S. and Canada)
 
1,500

1,581

(5%)
3%


1,500

1,581

(5%)
3%
Xeljanz
 
414

224

85%
87%
364

204

78%
50

19

*
*
All other I&I
 
33

24

39%
33%
3

(7
)
*
30

31

(3%)
(7%)
Rare Disease
 
$
1,182

$
1,198

(1%)
3%
$
379

$
393

(4%)
$
804

$
805

6%
BeneFIX
 
367

366

3%
159

157

2%
208

210

(1%)
4%
Genotropin
 
277

306

(9%)
(5%)
63

82

(23%)
214

224

(4%)
2%
Refacto AF/Xyntha
 
268

262

2%
6%
64

63

3%
204

199

2%
8%
Somavert
 
114

104

9%
12%
39

31

25%
75

73

2%
7%
Rapamune
 
93

106

(12%)
(4%)
42

52

(19%)
50

53

(6%)
10%
All other Rare Disease
 
63

53

18%
19%
11

8

33%
52

45

16%
17%
Consumer Healthcare
 
$
1,659

$
1,648

1%
7%
$
909

$
826

10%
$
750

$
822

(9%)
5%
PFIZER ESSENTIAL HEALTH (EH)(f)
 
$
12,013

$
10,348

16%
22%
$
4,897

$
2,996

63%
$
7,116

$
7,352

(3%)
5%
Legacy Established Products (LEP)(g)
 
$
5,664

$
5,782

(2%)
5%
$
1,979

$
1,726

15%
$
3,686

$
4,056

(9%)
Lipitor
 
872

950

(8%)
86

79

8%
786

870

(10%)
Premarin family
 
507

491

3%
4%
479

457

5%
29

34

(15%)
(2%)
Norvasc
 
476

503

(5%)
(1%)
19

18

6%
457

485

(6%)
(1%)
EpiPen
 
190

161

18%
19%
169

138

22%
21

23

(10%)
(5%)
Xalatan/Xalacom
 
182

201

(9%)
(5%)
12

13

(5%)
170

188

(10%)
(5%)
Relpax
 
165

162

2%
2%
116

109

7%
49

54

(9%)
(7%)
Zoloft
 
156

179

(13%)
(5%)
32

28

15%
124

151

(18%)
(9%)
Zithromax/Zmax(h)
 
147

140

5%
10%
3


*
144

140

3%
8%
Effexor
 
137

147

(7%)
(1%)
45

50

(9%)
92

97

(6%)
3%
Tikosyn
 
116

79

48%
48%
116

79

48%


Xanax/Xanax XR
 
108

109

(1%)
4%
25

20

20%
83

89

(6%)
Cardura
 
94

106

(12%)
(7%)
3

2

56%
91

105

(13%)
(8%)
Neurontin
 
91

103

(12%)
1%
25

24

1%
66

78

(15%)
1%
Depo-Provera
 
68

88

(23%)
(19%)
25

30

(16%)
43

58

(27%)
(20%)
All other LEP
 
2,355

2,364

9%
823

678

21%
1,532

1,685

(9%)
3%
Sterile Injectable Pharmaceuticals (SIP)(i)
 
$
3,021

$
1,479

*
*
$
1,775

$
544

*
$
1,246

$
936

33%
42%
Medrol(h)
 
228

186

23%
29%
146

99

48%
82

87

(6%)
6%
Sulperazon
 
201

179

13%
18%


201

179

13%
18%
Fragmin
 
160

162

(1%)
4%
16

9

87%
144

153

(6%)
Tygacil
 
134

150

(11%)
(3%)
41

57

(29%)
93

93

1%
13%
All other SIP
 
2,297

803

*
*
1,572

379

*
726

424

71%
80%
Peri-LOE Products(j)
 
$
2,201

$
2,843

(23%)
(18%)
$
485

$
619

(22%)
$
1,716

$
2,224

(23%)
(18%)
Lyrica EH(c)
 
431

652

(34%)
(31%)


431

652

(34%)
(31%)
Pristiq
 
372

338

10%
13%
300

255

18%
73

83

(12%)
Celebrex
 
355

428

(17%)
(12%)
56

80

(29%)
299

349

(14%)
(9%)
Vfend
 
319

345

(8%)
(3%)
22

20

7%
297

325

(8%)
(3%)
Zyvox
 
240

530

(55%)
(50%)
42

206

(80%)
199

324

(39%)
(32%)
Viagra EH(d)
 
197

221

(11%)
(4%)


197

221

(11%)
(4%)
Revatio
 
140

128

10%
12%
46

34

34%
94

93

1%
4%
All other Peri-LOE Products
 
146

201

(27%)
(22%)
20

23

(14%)
125

177

(29%)
(24%)
Infusion Systems(k)
 
$
599

$

*
*
$
470

$

*
$
129

$

*
*
Biosimilars(l)
 
$
145

$

*
*
$

$

$
145

$

*
*
Pfizer CentreOne(m)
 
$
384

$
244

57%
60%
$
188

$
108

74%
$
196

$
136

44%
47%
Total Lyrica(c)
 
$
2,490

$
2,406

4%
6%
$
1,570

$
1,272

23%
$
920

$
1,134

(19%)
(15%)
Total Viagra(d)
 
$
796

$
843

(6%)
(3%)
$
584

$
605

(3%)
$
212

$
238

(11%)
(4%)
Total Alliance revenues
 
$
736

$
533

38%
39%
$
456

$
351

30%
$
281

$
181

55%
57%
See end of tables for notes. Compared with the first six months of 2015, revenues for the first six months of 2016 were favorably impacted by approximately $800
million as a result of first-half 2016 having four additional selling days in the U.S. and four additional selling days in international markets.

- 30 -

PFIZER INC.
INTERNATIONAL REVENUES BY GEOGRAPHIC REGION
SIX MONTHS 2016 and 2015 - (UNAUDITED)


 
 
DEVELOPED EUROPE(n)
DEVELOPED REST OF WORLD(o)
EMERGING MARKETS(p)
 
 
2016
2015
% Change
2016
2015
% Change
2016
2015
% Change
(MILLIONS OF DOLLARS)
 
Total
Oper.
Total
Oper.
Total
Oper.
TOTAL INTERNATIONAL REVENUES
 
$
4,810

$
4,691

3%
5%
$
3,238

$
3,050

6%
7%
$
5,143

$
5,548

(7%)
8%
PFIZER INNOVATIVE HEALTH (IH)(b)
 
$
2,675

$
2,477

8%
11%
$
1,596

$
1,458

9%
10%
$
1,804

$
2,002

(10%)
8%
Internal Medicine
 
$
263

$
88

*
*
$
659

$
555

19%
18%
$
239

$
236

1%
22%
Lyrica IH(c)
 


379

340

11%
10%
110

142

(23%)
2%
Viagra IH(d)
 


16

17

(9%)
1%


Chantix/Champix
 
40

40

1%
5%
68

63

7%
12%
18

26

(28%)
(15%)
Toviaz
 
35

34

5%
9%
39

32

21%
19%
7

6

9%
21%
BMP2
 






Alliance revenues(q)
 
165

83

99%
*
108

61

78%
76%
(1
)
8

*
*
All other Internal Medicine
 
23

(68
)
*
*
49

42

17%
15%
105

55

91%
*
Vaccines
 
$
400

$
374

7%
10%
$
214

$
208

3%
5%
$
488

$
596

(18%)
(11%)
Prevnar/Prevenar 13
 
289

293

(1%)
2%
211

207

2%
4%
467

581

(20%)
(12%)
FSME/IMMUN-TicoVac
 
58

51

14%
14%


11

14

(23%)
(24%)
All other Vaccines
 
53

30

78%
83%
3


*
*
10

1

*
*
Oncology
 
$
317

$
303

5%
8%
$
145

$
130

11%
10%
$
217

$
188

15%
31%
Ibrance
 
5


*
*


13


*
*
Sutent
 
170

175

(3%)
57

57

1%
126

133

(5%)
10%
Xalkori
 
73

60

22%
25%
28

24

18%
20%
50

37

37%
46%
Inlyta
 
53

53

3%
46

41

11%
7%
22

14

55%
82%
All other Oncology
 
16

14

11%
14%
14

8

70%
65%
5

4

21%
41%
Inflammation & Immunology (I&I)
 
$
995

$
1,018

(2%)
1%
$
256

$
243

5%
5%
$
329

$
371

(12%)
17%
Enbrel (Outside Canada)
 
986

1,013

(3%)
203

204

(1%)
(1%)
311

364

(15%)
13%
Xeljanz
 
9

5

92%
98%
23

7

*
*
18

7

*
*
All other I&I
 


30

31

(3%)
(7%)


Rare Disease
 
$
485

$
486

3%
$
195

$
192

2%
3%
$
123

$
126

(2%)
21%
BeneFIX
 
126

125

4%
62

66

(6%)
(2%)
21

19

9%
25%
Genotropin
 
93

99

(6%)
(3%)
79

77

2%
42

47

(11%)
18%
Refacto AF/Xyntha
 
156

155

1%
4%
23

20

15%
25%
25

24

1%
15%
Somavert
 
60

59

2%
4%
8

7

11%
13%
7

7

23%
Rapamune
 
21

21

(4%)
7

7

(9%)
23

25

(7%)
23%
All other Rare Disease
 
30

27

10%
12%
16

14

18%
14%
7

5

42%
51%
Consumer Healthcare
 
$
214

$
208

3%
5%
$
127

$
130

(2%)
8%
$
409

$
485

(16%)
4%
PFIZER ESSENTIAL HEALTH (EH)(f)
 
$
2,135

$
2,214

(4%)
(1%)
$
1,642

$
1,592

3%
3%
$
3,339

$
3,546

(6%)
9%
Legacy Established Products (LEP)(g)
 
$
783

$
796

(2%)
1%
$
961

$
1,036

(7%)
(7%)
$
1,942

$
2,224

(13%)
4%
Lipitor
 
93

103

(10%)
(7%)
117

131

(11%)
(8%)
576

636

(9%)
2%
Premarin family
 
3

4

(29%)
(26%)
13

13

(5%)
2%
13

17

(20%)
Norvasc
 
35

39

(9%)
(7%)
119

135

(12%)
(13%)
302

311

(3%)
4%
Epipen
 


21

23

(10%)
(5%)


Xalatan/Xalacom
 
37

45

(18%)
(16%)
78

80

(3%)
(4%)
55

63

(13%)
2%
Relpax
 
20

28

(28%)
(25%)
21

19

8%
6%
8

7

17%
28%
Zoloft
 
17

15

11%
14%
48

78

(38%)
(39%)
58

58

1%
25%
Zithromax/Zmax(h)
 
24

23

7%
10%
28

30

(8%)
(10%)
92

87

6%
13%
Effexor
 
31

34

(10%)
(8%)
21

17

26%
32%
40

47

(14%)
1%
Tikosyn
 






Xanax/Xanax XR
 
41

41

3%
10

11

(10%)
(12%)
32

37

(12%)
Cardura
 
27

33

(16%)
(14%)
23

27

(14%)
(16%)
40

45

(9%)
2%
Neurontin
 
22

23

(4%)
(1%)
15

16

(8%)
(5%)
29

39

(25%)
4%
Depo-Provera
 
10

11

(6%)
(2%)
5

5

(2%)
8%
27

42

(35%)
(29%)
All other LEP
 
422

398

6%
9%
442

450

(2%)
(3%)
668

837

(20%)
4%
Sterile Injectable Pharmaceuticals (SIP)(i)
 
$
334

$
263

27%
30%
$
265

$
143

85%
88%
$
648

$
530

22%
35%
Medrol(h)
 
27

29

(6%)
(3%)
12

12

(6%)
(4%)
43

46

(6%)
15%
Sulperazon
 


7

8

(14%)
(17%)
194

171

14%
20%
Fragmin
 
83

88

(5%)
(1%)
35

39

(10%)
(1%)
25

26

(3%)
4%
Tygacil
 
32

29

11%
13%
3

3

(5%)
2%
58

60

(4%)
14%
All other SIP
 
191

117

63%
66%
208

80

*
*
327

227

44%
59%
Peri-LOE Products(j)
 
$
734

$
1,067

(31%)
(29%)
$
345

$
396

(13%)
(13%)
$
637

$
762

(16%)
(4%)
Lyrica EH(c)
 
376

581

(35%)
(33%)


55

71

(22%)
(14%)
Pristiq
 
11

8

36%
40%
35

47

(25%)
(18%)
27

28

(3%)
20%
Celebrex
 
16

25

(35%)
(33%)
135

156

(13%)
(15%)
148

168

(12%)
1%
Vfend
 
120

129

(7%)
(4%)
62

58

6%
4%
115

137

(16%)
(5%)
Zyvox
 
75

152

(51%)
(48%)
39

48

(18%)
(20%)
84

123

(32%)
(15%)
Viagra EH(d)
 
24

28

(15%)
(12%)
18

20

(9%)
(6%)
155

173

(11%)
(2%)
Revatio
 
62

61

1%
4%
17

18

(6%)
(9%)
15

14

11%
21%
All other Peri-LOE Products
 
49

81

(40%)
(38%)
39

49

(20%)
(21%)
38

47

(20%)
(2%)
Infusion Systems(k)
 
$
29

$

*
*
$
45

$

*
*
$
55

$

*
*
Biosimilars(l)
 
$
129

$

*
*
$
3

$

*
*
$
13

$

*
*
Pfizer CentreOne(m)
 
$
128

$
88

45%
47%
$
24

$
17

44%
47%
$
43

$
31

42%
45%
Total Lyrica(c)
 
$
376

$
581

(35%)
(33%)
$
379

$
340

11%
10%
$
165

$
213

(23%)
(3%)
Total Viagra(d)
 
$
24

$
28

(15%)
(12%)
$
34

$
37

(9%)
(3%)
$
155

$
173

(11%)
(2%)
Total Alliance revenues
 
$
171

$
104

65%
69%
$
109

$
63

73%
71%
$
1

$
15

(97%)
(93%)
See end of tables for notes. Compared with the first six months of 2015, revenues for the first six months of 2016 were favorably impacted by approximately $800 million as a result of first-half 2016 having four additional selling days in the U.S. and four additional selling days in international markets.

- 31 -


PFIZER INC.
NOTES TO REVENUES TABLE INFORMATION
(UNAUDITED)

(a)
Total International represents Developed Europe region + Developed Rest of World region + Emerging Markets region. Details for these regions are described in footnotes (n) to (p) below, respectively, and the product revenues from these regions are described on pages 29 and 31.
(b)
The Pfizer Innovative Health business, previously known as the Innovative Products business, encompasses Internal Medicine, Vaccines, Oncology, Inflammation & Immunology, Rare Disease and Consumer Healthcare.
(c)
Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in Lyrica EH. All other Lyrica revenues are included in Lyrica IH. Total Lyrica revenues represent the aggregate of worldwide revenues from Lyrica IH and Lyrica EH.
(d)
Viagra revenues from the U.S. and Canada are included in Viagra IH. All other Viagra revenues are included in Viagra EH. Total Viagra revenues represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.
(e)
Includes Eliquis (2016 and 2015) and Rebif (2015 only).
(f)
The Pfizer Essential Health business, previously known as the Established Products business, encompasses Legacy Established Products, Sterile Injectable Pharmaceuticals, Peri-LOE Products, Infusion Systems, Biosimilars and Pfizer CentreOne and includes all legacy Hospira commercial operations. Hospira's commercial operations, including the legacy Hospira One-2-One sterile injectables contract manufacturing business, are included in EH's operating results in our consolidated statements of income, commencing from the acquisition date of September 3, 2015. As a result, EH's revenues for the second quarter and first six months of 2015 do not include Hospira's revenues. Also, effective as of the beginning of 2016, our entire contract manufacturing business, Pfizer CentreOne, is part of EH. Pfizer CentreOne consists of (i) legacy Pfizer's contract manufacturing and active pharmaceutical ingredient sales operation, including our manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) legacy Hospira's One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside our operating segments and its revenues were reported as other business activities. We have reclassified prior period PCS revenues ($133 million in the second quarter of 2015 and $244 million in the first six months of 2015) to conform to the current period presentation as part of EH.
(g)
Legacy Established Products include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products).
(h)
Prior period revenues for Medrol and Zithromax/Zmax may not agree to previously-disclosed revenues because revenues for those products are now split between the Legacy Established Products and the Sterile Injectable Pharmaceuticals categories.
(i)
Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
(j)
Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products primarily include Lyrica in certain developed Europe markets, Pristiq globally, Celebrex, Zyvox and Revatio in most developed markets, Vfend and Viagra in certain developed Europe markets and Japan, and Inspra in the EU.
(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) in certain European markets, Nivestim (biosimilar filgrastim) in certain Asian markets and Retacrit (biosimilar epoetin zeta) in certain international markets.
(m)
Pfizer CentreOne includes (i) revenues from legacy Pfizer's contract manufacturing and active pharmaceutical ingredient sales operation, including revenues related to our manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) revenues from legacy Hospira’s One-2-One sterile injectables contract manufacturing operation.
(n)
Developed Europe region includes the following markets: Western Europe, Finland and the Scandinavian countries.
(o)
Developed Rest of World region includes the following markets: Australia, Canada, Japan, New Zealand and South Korea.
(p)
Emerging Markets region includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Africa, Eastern Europe, Central Europe, the Middle East and Turkey.
(q)
Includes Eliquis.
*
Indicates calculation not meaningful.
 
Amounts may not add due to rounding. All percentages have been calculated using unrounded amounts.


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DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of August 2, 2016. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.
This earnings release and the related attachments contain forward-looking statements about our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from our recent acquisitions of Hospira, Inc. (Hospira) and Anacor Pharmaceuticals, Inc. (Anacor) and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
the outcome of research and development activities, including, without limitation, the ability to meet anticipated pre-clinical and clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the possibility of unfavorable pre-clinical and clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data;
decisions by regulatory authorities regarding whether and when to approve our drug applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our products; and uncertainties regarding our ability to address the comments in complete response letters received by us with respect to certain of our drug applications to the satisfaction of the FDA;
the speed with which regulatory authorizations, pricing approvals and product launches may be achieved;
the outcome of post-approval clinical trials, which could result in the loss of marketing approval for a product or changes in the labeling for, and/or increased or new concerns about the safety or efficacy of, a product that could affect its availability or commercial potential;
risks associated with interim data, including the risk that final results of studies for which interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development of the applicable product candidate or indication;
the success of external business-development activities, including the ability to satisfy the conditions to closing of any announced transactions in the anticipated time frame or at all;
competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates;
the implementation by the FDA and regulatory authorities in certain other countries of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products, with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights;
risks related to our ability to develop and launch biosimilars;
the ability to meet generic and branded competition after the loss of patent protection for our products or competitor products;
the ability to successfully market both new and existing products domestically and internationally;
difficulties or delays in manufacturing;
trade buying patterns;
the impact of existing and future legislation and regulatory provisions on product exclusivity;
trends toward managed care and healthcare cost containment;
the impact of any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented, and/or any significant additional taxes or fees that may be imposed on the pharmaceutical industry as part of any broad deficit-reduction effort;

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the impact of U.S. healthcare legislation enacted in 2010—the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act—and of any modification, repeal or invalidation of any of the provisions thereof;
U.S. federal or state legislation or regulatory action affecting, among other things, pharmaceutical product pricing, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; restrictions on direct-to-consumer advertising; limitations on interactions with healthcare professionals; or the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines; as well as pricing pressures for our products as a result of highly competitive insurance markets;
legislation or regulatory action in markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
the exposure of our operations outside the U.S. to possible capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest, unstable governments and legal systems and inter-governmental disputes;
contingencies related to actual or alleged environmental contamination;
claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates;
any significant breakdown, infiltration or interruption of our information technology systems and infrastructure;
legal defense costs, insurance expenses, settlement costs, the risk of an adverse decision or settlement and the adequacy of reserves related to product liability, patent matters, government investigations, consumer, commercial, securities, antitrust, environmental, employment, tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings;
our ability to protect our patents and other intellectual property, both domestically and internationally;
interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates and the volatility following the United Kingdom (U.K.) referendum in which voters approved an exit from the EU;
governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals;
the end result of any negotiations between the U.K. government and the EU regarding the terms of the U.K.'s exit from the EU, which could have implications on our research, commercial and general business operations in the U.K.;
any significant issues involving our largest wholesaler customers, which account for a substantial portion of our revenues;
the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines;
any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards;
any significant issues that may arise related to our joint ventures and other third-party business arrangements;
changes in U.S. generally accepted accounting principles;
uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; and the related risk that our allowance for doubtful accounts may not be adequate;
any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas;
growth in costs and expenses;

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changes in our product, segment and geographic mix;
the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items;
the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls, withdrawals and other unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including those related to our research and development organization, and of the internal separation of our commercial operations into our current operating structure;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
risks related to internal control over financial reporting; and
risks and uncertainties related to our recent acquisitions of Hospira and Anacor, including, among other things, the ability to realize the anticipated benefits of the acquisitions of Hospira and Anacor, including the possibility that expected cost savings related to the acquisition of Hospira and accretion related to the acquisitions of Hospira and Anacor will not be realized or will not be realized within the expected time frame; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; significant transaction costs; and unknown liabilities.
We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors should bear this in mind as they consider forward-looking statements, and are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors”, and in our subsequent reports on Form 8-K.
The operating segment information provided in this earnings release and the related attachments does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented.
This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.

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