[November 01, 2016]

PFIZER REPORTS THIRD-QUARTER 2016 RESULTS

Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter 2016 and narrowed certain 2016 financial guidance ranges.

On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, financial results for the third quarter and first nine months of 2016 include legacy Hospira global operations while financial results for the third quarter and first nine months of 2015 include only one month of legacy Hospira U.S. operations but no financial results from legacy Hospira international operations⁽³⁾.

On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor). Therefore, financial results for the third quarter and first nine months of 2016 reflect approximately three months of legacy Anacor operations, which were immaterial.

On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation). Therefore, financial results for the third quarter and first nine months of 2016 reflect three business days of legacy Medivation operations, which were immaterial.

The Company manages its commercial operations through two distinct businesses: Pfizer Innovative Health (IH)⁽⁴⁾ (formerly the Innovative Products business) and Pfizer Essential Health (EH)⁽⁴⁾⁽⁵⁾ (formerly the Established Products business). Financial results for each of these businesses are presented in the Operating Segment Information section located at the hyperlink below.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances⁽⁶⁾ 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 third quarter and first nine months of 2016 and 2015 are summarized below.

* Indicates calculation not meaningful.

2016 FINANCIAL GUIDANCE⁽⁷⁾

Pfizer's updated 2016 financial guidance is presented below.

On November 1, 2016, Pfizer announced the decision to discontinue development of bococizumab. As a result, 2016 financial guidance for Adjusted R&D expenses⁽²⁾ was negatively impacted by $0.3 billion and Adjusted Diluted EPS⁽²⁾ was negatively impacted by $0.04. A reconciliation of these financial guidance components is presented below.

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, "Our business continues to perform well as demonstrated by the quarter's financial results. Our Innovative Health business executed strongly behind the latest product launches, and our two recent acquisitions -- Medivation and Anacor -- are providing new near-term opportunities to potentially drive incremental growth for the business as its product pipeline continues to mature. We see this business as highly focused on those therapeutic areas where it is best positioned to deliver value to patients.

"Within the Essential Health business we continued to refine the portfolio with the announced acquisition of the small molecule anti-infectives franchise from AstraZeneca and the announced sale of the Hospira infusion systems portfolio to ICU Medical. In addition, later this month we will begin shipping Inflectra, a biosimilar to Remicade^®(8) that will be the first biosimilar monoclonal antibody to be available in the U.S. We remain confident that we will be well-positioned in the emerging biosimilars market with our broad pipeline. With continued strength in emerging markets, the sterile injectables business and the biosimilars portfolio, we anticipate the Essential Health business will be able to transition to a modest revenue growth business on an overall portfolio basis.

"By maintaining our overall high level of financial flexibility and discipline, we are in a strong position to support the strategic initiatives for each business and will remain opportunistic to business development activity in addition to continuing to actively manage our cost structure," Mr. Read concluded.

Frank D'Amelio, Chief Financial Officer, stated, "Overall, I am pleased with our third-quarter 2016 financial results and with our ability to continue delivering shareholder value through prudent capital allocation. We grew revenues by 3% operationally, excluding the impact of foreign exchange and legacy Hospira operations. We also continued to deliver significant value directly to shareholders by returning $10.5 billion to shareholders through dividends and share repurchases in the first nine months of 2016, including the completion of a $5 billion accelerated share repurchase agreement in June 2016. Additionally, we announced and completed the acquisition of Medivation in the third quarter of 2016.

"We raised the midpoint of the range for our 2016 Revenue guidance primarily to reflect our strong performance to date and the inclusion of legacy Medivation operations in fourth-quarter 2016. The midpoint of our range for our 2016 Adjusted Diluted EPS⁽²⁾ guidance was negatively impacted solely due to our decision to discontinue development of bococizumab. Excluding this impact, the midpoint of our range for our 2016 Adjusted Diluted EPS⁽²⁾ guidance would have increased by $0.02," Mr. D'Amelio concluded.

QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2016 vs. Third-Quarter 2015)

Third-quarter 2016 revenues totaled $13.0 billion, an increase of $957 million, or 8% compared to the prior-year quarter, reflecting operational growth of $1.2 billion, or 10%, partially offset by the unfavorable impact of foreign exchange of $224 million, or 2%. Excluding the third-quarter 2015 and 2016 contributions from legacy Hospira operations and foreign exchange, Pfizer-standalone revenues increased by $381 million operationally, or 3%.

Innovative Health Highlights

• IH delivered strong revenue growth again this quarter, up 10% operationally, driven by continued growth from key brands including Ibrance, primarily in the U.S., Eliquis globally as well as Xeljanz, Lyrica and Chantix/Champix, all primarily in the U.S. Compared to the year-ago quarter, Ibrance revenue more than doubled while global operational revenue growth for Eliquis and Xeljanz was 92% and 86%, respectively.
• This strong third-quarter 2016 operational performance was achieved despite the loss of Rebif alliance revenue compared to the prior-year quarter due to the year-end 2015 expiry of the collaboration agreement to co-promote Rebif in the U.S. as well as lower revenues for Enbrel in most developed Europe markets, primarily due to biosimilar competition.
• Global Prevnar/Prevenar 13 revenues were down 2% operationally. In the U.S., Prevnar 13 revenues decreased 3% driven by an expected decline in revenues for the Adult indication due to a high initial capture rate of the eligible population following its successful fourth-quarter 2014 launch, which resulted in a smaller remaining "catch up" opportunity compared to the prior-year quarter, partially offset by the impact of favorable timing of government purchases for the pediatric indication. Internationally, Prevenar 13 revenues grew 1% operationally driven by a modest increase in uptake for the Adult indication.

Essential Health Highlights

• EH revenues increased 10% operationally, primarily due to the inclusion of legacy Hospira operations, and to a lesser extent, the performance of the EH Standalone Sterile Injectables⁽⁹⁾ portfolio, partially offset by the loss of exclusivity and associated generic competition for certain Peri-LOE products⁽⁹⁾, primarily Lyrica and Zyvox, both primarily in most developed Europe markets.
• Revenues excluding the contribution from the legacy Hospira portfolio (EH Standalone) declined 5% operationally, reflecting a 15% operational decline from the Peri-LOE Products⁽⁹⁾ portfolio and a 4% operational decline from the EH Standalone Legacy Established Products⁽⁹⁾ portfolio, partially offset by 7% operational growth from the EH Standalone Sterile Injectable Pharmaceuticals⁽⁹⁾ portfolio.
• EH revenues in emerging markets increased 9% operationally, primarily driven by the inclusion of legacy Hospira operations as well as 20% operational growth from the EH Standalone Sterile Injectable Pharmaceuticals⁽⁹⁾ portfolio and 3% operational growth from the EH Standalone Legacy Established Products⁽⁹⁾ portfolio.

GAAP Reported⁽¹⁾ Income Statement Highlights

* Indicates calculation not meaningful.

The increase in third-quarter 2016 Other deductions--net⁽¹⁾ was primarily driven by an impairment charge as a result of the pending Hospira Infusion Systems transaction.

The diluted weighted-average shares outstanding declined by 105 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.

Adjusted⁽²⁾ Income Statement Highlights

A full reconciliation of Reported⁽¹⁾ to Adjusted⁽²⁾ financial measures and associated footnotes can be found starting on page 20 of the press release located at the hyperlink below.

RECENT NOTABLE DEVELOPMENTS (SINCE AUGUST 2, 2016)

Product Developments

• Chantix/Champix (varenicline) -- In September 2016, the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) evaluating the neuropsychiatric safety of Chantix. The Committees recommended by a majority vote to remove the boxed warning regarding serious neuropsychiatric adverse events from the Chantix labeling. The role of the Advisory Committees is to provide recommendations to the FDA; however, the FDA makes the final labeling decisions. Earlier this year, Pfizer submitted to the FDA a supplemental New Drug Application (sNDA) requesting updates to the Chantix labeling based on the safety and efficacy outcomes of EAGLES. In addition to requesting removal of the boxed warning, Pfizer proposed retaining the Warnings and Precautions section in the labeling regarding serious neuropsychiatric events occurring in patients attempting to quit smoking and updating it with EAGLES data. Pfizer believes that such a warning would sufficiently inform prescribers of the possibility that these types of events may occur.
• Ibrance (palbociclib) -- Pfizer announced in September 2016 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Ibrance be granted marketing authorization in the European Union (EU) for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. The CHMP's positive opinion is for Ibrance to be used in combination with an aromatase inhibitor, as well as in combination with fulvestrant in women who have received prior endocrine therapy. The CHMP's opinion will now be reviewed by the European Commission (EC).
• Inflectra (infliximab-dyyb) -- Pfizer announced in October 2016 that it will begin shipment of Inflectra, a biosimilar of Remicade^®(8) (infliximab) to wholesalers in the U.S. in late November 2016. Inflectra will be introduced at a 15% discount to the current wholesaler acquisition cost (WAC) of Remicade^®(8), its reference product. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations. Pfizer holds exclusive commercialization rights to Celltrion's Inflectra in the U.S., and has already successfully introduced Inflectra in other markets across the globe.
• Inlyta (axitinib) -- At the annual meeting of the European Society for Medical Oncology (ESMO 2016) in October 2016, Pfizer announced data from two ongoing, investigational Phase 1b studies of Inlyta combined with a checkpoint inhibitor:
  • In one study, Inlyta was combined with pembrolizumab, a PD-1 inhibitor known as Keytruda^®(10) and marketed by Merck, known as MSD outside the United States and Canada (Merck/MSD), in treatment-naïve patients with advanced renal cell carcinoma (RCC). The study was designed to establish dosing and evaluate the safety and anti-tumor activity of Inlyta when combined with pembrolizumab in first-line treatment of advanced RCC. Early indicators from the study point to strong response rates for this combination, with 37 patients (71.2%, confidence internal 56.9, 82.9) achieving objective responses (three complete responses and 34 partial responses); 10 patients had stable disease and 5 patients had disease progression.
  • Preliminary results from a similar, separate study (JAVELIN Renal 100) combining Inlyta with avelumab, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody that is being co-developed by Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer, were also presented and suggested evidence of anti-tumor activity for this combination. In this study, five out of six patients treated so far had confirmed partial responses (objective response rate 83.3%, 95% confidence interval: 35.9, 99.6) and one patient with tumor shrinkage not meeting partial response criteria had stable disease.

Based on these Phase 1 results, two independent global Phase 3 trials evaluating these combinations -- Inlyta plus pembrolizumab and Inlyta plus avelumab -- each compared with Sutent (sunitinib) in first-line advanced RCC are now enrolling patients.

• Sutent (sunitinib malate) -- At ESMO 2016, Pfizer presented results from the Phase 3 S-TRAC clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer) investigating Sutent as an adjuvant therapy. The trial showed Sutent extended disease-free survival by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of RCC. The results were also published online by The New England Journal of Medicine. Based on the results of S-TRAC, Pfizer is in discussions with global regulatory authorities to determine potential next steps.
• Trumenba (rLP2086, Meningococcal Serogroup B Bivalent Recombinant Lipoprotein vaccine) -- In October 2016, Pfizer announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the following for Trumenba:
  • For persons at increased risk for meningococcal disease and for use during serogroup B outbreaks, 3 doses of Trumenba should be administered at 0, 1-2, and 6 months.
  • When given to healthy adolescents who are not at increased risk for meningococcal disease, 2 doses of Trumenba should be administered at 0 and 6 months. If the second dose is given at an interval of less than 6 months, a third dose should be given at least 6 months after the first dose.

The ACIP recommendation will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the recommendations are published in the Morbidity and Mortality Weekly Report (MMWR). In 2015, the CDC's ACIP recommended serogroup B meningococcal (MenB) vaccination for certain persons aged 10 years and older at increased risk for meningococcal disease. They also recommended that a MenB vaccine series may be administered to adolescents and young adults 16 through 23 years of age (preferred age 16 through 18) to provide short-term protection against most strains of MenB disease. In October 2014, Trumenba was granted Accelerated Approval by the FDA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

• Xalkori (crizotinib) -- In August 2016, Pfizer announced that the EC has approved Xalkori for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). In the EU, Xalkori is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March 2016, Xalkori was approved by the FDA for patients with metastatic NSCLC whose tumors are ROS1-positive.
• Xtandi (enzalutamide) -- In October 2016, Pfizer and Astellas Pharma Inc. announced that the FDA approved a sNDA to update the U.S. product labeling for Xtandi capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with Xtandi compared to patients who were treated with bicalutamide. The TERRAIN study evaluated men with metastatic CRPC and the results from this study were published in The Lancet Oncology. The updated label includes data that enzalutamide reduces the risk of radiographic progression or death by 40% compared with bicalutamide, showing a median rPFS of 19.5 months for the enzalutamide group versus a median of 13.4 months for the bicalutamide group (hazard ratio = 0.60 [0.43, 0.83]; 95% confidence interval) based on an analysis recommended by the FDA. The safety profile of enzalutamide was consistent with results of earlier enzalutamide trials.

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.

• Avelumab (PF-06834635, MSB0010718C) -- In October 2016, Merck KGaA and Pfizer announced that the EMA has validated for review Merck KGaA's Marketing Authorization Application (MAA) for avelumab, for the proposed indication of metastatic Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, which impacts approximately 2,500 Europeans a year. If approved, avelumab could be the first approved treatment indicated for metastatic MCC in the EU. The avelumab metastatic MCC MAA submission is supported by data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase 2 study of 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment.
• Bococizumab (PF-04950615, RN316) -- Pfizer announced in November 2016 the discontinuation of the global clinical development program for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development program, including the two ongoing cardiovascular outcome studies.
• Ertugliflozin (PF-04971729) -- Pfizer and Merck/MSD announced in September 2016 that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint. Both 5 mg and 15 mg daily doses of ertugliflozin showed significantly greater reductions in A1C (an average measure of blood glucose over the past two to three months) of 0.69% and 0.76%, respectively, compared with placebo (p<0.001, for both comparisons), when added to patients on a background of sitagliptin (100 mg/day) and stable metformin (=1500 mg/day). These study results were presented for the first time during the 52^nd Annual Meeting of the European Association for the Study of Diabetes (EASD). Merck/MSD and Pfizer plan to submit New Drug Applications to the FDA for ertugliflozin and two fixed-dose combinations (ertugliflozin plus Januvia^®(11) (sitagliptin) and ertugliflozin plus metformin) by the end of 2016, with additional regulatory submissions outside of the U.S. to follow in 2017.
• PF-04518600 -- At ESMO 2016, Pfizer presented the latest safety, anti-tumor activity and biomarker data from a first-in-human single-agent study of investigational immunotherapy PF-04518600, an OX40 agonist, in a variety of advanced cancers. Preliminary results evaluating 25 patients suggest that PF-04518600 is tolerated up to 3 mg/kg and showed early anti-tumor activity.
• PF-06438179 (infliximab-Pfizer) -- Pfizer announced in September 2016 that the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade^®(8) (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology 20 (ACR20) response at Week 14. PF-06438179 is being developed as a potential biosimilar to Remicade^®(8). In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 28 countries that form the European Economic Area (EEA). Under the terms of the agreement, Pfizer retains commercialization and manufacturing rights to PF-06438179 in countries outside the EEA.

Corporate Developments

• In October 2016, ICU Medical Inc. (ICU Medical) and Pfizer announced that they entered into a definitive agreement under which ICU Medical will acquire all of Pfizer's global infusion therapy net assets, Hospira Infusion Systems (HIS), for approximately $1 billion in cash and ICU Medical stock. HIS includes IV pumps, solutions and devices. Under the terms of the agreement, Pfizer will receive approximately $400 million in newly issued shares of ICU Medical common stock and $600 million in cash from ICU Medical, subject to customary adjustments for net working capital. Upon completion of the transaction, which the companies expect to occur in the first quarter of 2017 subject to customary closing conditions including required regulatory approvals, Pfizer will own approximately 16.6% of ICU Medical. Pfizer has also agreed to certain restrictions on transfer of its shares for at least 18 months.
• In September 2016, Pfizer announced the completion of its acquisition of Medivation for approximately $14.3 billion in cash ($13.9 billion, net of cash acquired). Pfizer continues to expect the transaction to be immediately accretive to Adjusted Diluted EPS⁽²⁾ by approximately $0.05 in the first full year following the close, with additional accretion and growth anticipated thereafter⁽¹²⁾. Medivation is now a wholly-owned subsidiary of Pfizer.
• In September 2016, Pfizer announced that, after an extensive evaluation, the company's Board of Directors and Executive Leadership Team determined that Pfizer is best positioned to maximize future shareholder value creation in its current structure and will not pursue splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly-traded companies at this time. Pfizer will move forward with a focus on its strategic priorities to grow and increase operational efficiency to be more competitive.
• In September 2016, Pfizer entered into an exclusive option and license agreement with OncoImmune, Inc. (OncoImmune) for ONC-392, a novel, potentially differentiated preclinical anti-CTLA4 monoclonal antibody in a deal worth up to $250 million in upfront and potential milestone payments. Under the terms of the agreement, Pfizer plans to evaluate ONC-392 up until a certain agreed-upon time to determine whether it will exercise its option to exclusively license ONC-392 as well as any other OncoImmune anti-CTLA4 antibodies. If Pfizer exercises its option under the agreement, Pfizer would be responsible for all development and potential commercialization of the program, and OncoImmune would be eligible to receive potential developmental and commercial milestone payments as well as royalties, tiered from mid-single up to low-double digits, on sales of any potential resulting products.
• Pfizer announced in August 2016 that it entered into an agreement with AstraZeneca to acquire the development and commercialization rights to its small molecule anti-infectives business, primarily outside the U.S. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta^TM (ceftazidime-avibactam), the marketed agents Merrem^TM/Meronem^TM (meropenem) and Zinforo^TM (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL (ceftaroline fosamil-AVI). Under the terms of the agreement, Pfizer will make an upfront payment of $550 million to AstraZeneca upon the close of the transaction and a deferred payment of $175 million in January 2019. In addition, AstraZeneca is eligible to receive up to $250 million in milestone payments, up to $600 million in sales-related payments, as well as tiered royalties on sales of Zavicefta^TM and ATM-AVI in certain markets. The transaction is expected to close in the fourth quarter of 2016, subject to customary closing conditions, including antitrust clearance in certain jurisdictions.
• In August 2016, Pfizer acquired all the remaining equity in Bamboo Therapeutics, Inc. (Bamboo), a privately held biotechnology company, focused on developing gene therapies for the potential treatment of patients with certain rare diseases relating to neuromuscular conditions and those affecting the central nervous system, for $150 million, plus potential milestone payments of up to $495 million contingent upon the progression of key assets through development, regulatory approval and commercialization. Pfizer previously purchased a minority stake in Bamboo in the first quarter of 2016 for a payment of approximately $43 million. This acquisition provides Pfizer with several clinical and pre-clinical assets that complement its rare disease portfolio, an advanced recombinant Adeno-Associated Virus vector design and production technology, and a fully functional Phase 1/2 gene therapy manufacturing facility. Bamboo is now a wholly-owned subsidiary of Pfizer.

Please find Pfizer's press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:

http://www.pfizer.com/system/files/presentation/Q3_2016_PFE_Earnings_Press_Release_nafsdukf.pdf

(Note: If clicking on the above link does not open up a new web page, you may need to cut and paste the above URL into your browser's address bar.)

For additional details, see the associated financial schedules and product revenue tables attached to the press release located at the hyperlink referred to above and the attached disclosure notice.

• 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 October 2, 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 third-quarter 2016 and mid-October 2016 exchange rates for the remainder of the year.
• Guidance for 2016 revenues reflects the anticipated negative impact of $1.8 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 $0.20, including $0.08 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.

• 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 36 of the press release located at the hyperlink above.

DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of November 1, 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 acquisitions of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor) and Medivation, Inc. (Medivation) and our pending acquisition of AstraZeneca's small molecule anti-infectives business, 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 announced transactions in the anticipated time frame or at all, including our ability and the ability of ICU Medical, Inc. (ICU) and AstraZeneca to satisfy the conditions to closing the sale of our Hospira infusion systems net assets to ICU, and the acquisition of the small molecule anti-infective business from AstraZeneca, respectively;
• 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, including risks associated with "at risk" launches, defined as the marketing of a product by Pfizer before the final resolution of litigation (including any appeals) brought by a third party alleging that such marketing would infringe one or more patents owned or controlled by the third party;
• 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;
• 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;
• 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, Anacor and Medivation, including, among other things, the ability to realize the anticipated benefits of the acquisitions of Hospira, Anacor and Medivation, including the possibility that expected cost savings related to the acquisition of Hospira and accretion related to the acquisitions of Hospira, Anacor and Medivation 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 transactions 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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