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Pfizer: Billion Reflecting One Month Of Legacy Hospira U.S. Operations Third-Quarter Adjusted Diluted EPS

The following excerpt is from the company's SEC filing.

and Reported Diluted EPS

, Which Includes One Month of Legacy Hospira U.S. Operations

Third-Quarter

Reported Revenues

for Pfizer-Standalone (Excluding Legacy Hospira) Increased

Operationally; Innovative Products Business Grew

Operationally, Primarily Driven by Prevnar 13 Adult and Ibrance

Raised Midpoint of 2015 Financial Guidance Ranges for Reported Revenues

Billion and Adjusted Diluted EPS

, Primarily Reflecting Strong Performance to Date and Improved Business Outlook

NEW YORK, N.Y.,

Tuesday, October 27, 2015

– Pfizer Inc . (NYSE: PFE) reported financial results for

third-quarter

and announced increases to the midpoints of its 2015 financial guidance ranges for reported revenues

and adjusted diluted EPS

On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, and in accordance with Pfizer's domestic and international reporting periods

, financial results for third-quarter 2015 and the nine months ended September 27, 2015 reflect Pfizer's operations as well as one month of legacy Hospira U.S. operations but do not include any financial results from legacy Hospira international operations.

The company manages its commercial operations through two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business is composed of two operating segments: the Global Innovative Pharmaceutical segment (GIP)

and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC)

. The Established Products business consists of the Global Established Pharmaceutical segment (GEP)

, which includes all legacy Hospira commercial operations. Financial results for each of these segments 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. Results for the third quarter and first nine months of 2015 and 2014 are summarized below.

OVERALL RESULTS

($ in millions, except

per share amounts)

Nine Months

Change

$ 12,087

$ 12,361

$ 34,804

$ 36,487

Adjusted Income

10,449

11,088

Reported Net Income

REVENUES

($ in millions)

% Change

$ 6,752

$ 6,001

$ 19,120

$ 17,377

10,093

10,114

Global Oncology

$ 5,219

$ 6,239

$ 15,323

$ 18,742

Standalone

14,993

* Indicates calculation not meaningful.

SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES

(Favorable)/Unfavorable

Cost of Sales

$ 2,108

$ 2,244

$ 6,037

$ 6,550

Percent of Revenues

SI&A Expenses

3,276

3,299

9,726

9,804

R&D Expenses

1,725

1,788

5,334

5,114

$ 7,109

$ 7,330

$ 21,097

$ 21,468

Effective Tax Rate

2015 FINANCIAL GUIDANCE

Financial guidance ranges for reported revenues

and reported

diluted EPS were updated on September 30, 2015 solely to reflect the anticipated impact of legacy Hospira operations in Pfizer's financial results from September 3, 2015 through fiscal year-end 2015

The ranges for certain components of Pfizer's 2015 financial guidance have been updated today as set forth below, primarily reflecting the following:

operational factors impacting Pfizer-standalone (excluding legacy Hospira) operations, including strong performance to date coupled with an improved business outlook for the remainder of the year;

the anticipated impact of legacy Hospira operations from September 3, 2015 through fiscal year-end 2015

on financial guidance components other than reported revenues

a minimal favorable impact from foreign exchange rates since mid-July 2015.

$47.5 to $48.5 billion

(previously $46.5 to $47.5 billion)

Adjusted Cost of Sales

as a Percentage of Reported Revenues

18.7% to 19.2%

(previously 18.0% to 18.5%)

Adjusted SI&A Expenses

$13.6 to $14.1 billion

(previously $12.8 to $13.8 billion)

Adjusted R&D Expenses

$7.5 to $7.8 billion

(previously $7.3 to $7.6 billion)

Adjusted Other (Income)/Deductions

Approximately ($500 million) of income

Effective Tax Rate on Adjusted Income

Approximately 25.0%

$1.37 to $1.43

(previously $1.29 to $1.38)

$2.16 to $2.20

(previously $2.04 to $2.10)

A reconciliation of certain components of Pfizer's 2015 financial guidance provided on July 28, 2015 to Pfizer's 2015 financial guidance provided on October 27, 2015 is below.

2015 Financial Guidance Provided on July 28, 2015

$45.0 to $46.0 billion

$1.38 to $1.47

$2.01 to $2.07

Guidance Update Provided on September 30, 2015 Reflecting Anticipated Impact of Legacy Hospira Operations from September 3, 2015 -- Midpoint of range impacted by:

$1.5 billion

($0.09)

Guidance Update Provided on October 27, 2015 Reflecting Incremental Impact of R

estructuring Charges Associated with

the Hospira Acquisition -- Midpoint of range impacted by:

($0.02)

Guidance Update Provided on October 27, 2015 Reflecting Operational Factors Impacting Pfizer-Standalone (excluding legacy Hospira) Operations as well as Changes in FX Rates Since mid-July 2015 -- Midpoint of range impacted by:

$1.0 billion

2015 Financial Guidance Provided on October 27, 2015

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, “Our business continues to demonstrate strength across key product lines and geographies which has resulted in another quarter of strong financial performance. We have been intently focused on seeking to generate a greater portion of our earnings from increased revenues and I see our product portfolio, product pipeline and recent business development activity as supporting this objective. Importantly, our research pipeline continues to advance with a focus on therapeutic areas of high unmet need where we also have seen advances in biology which could support the development of potential important new therapies to further strengthen our Innovative Products business. The recent addition of the Hospira business nicely augments our Established Products business, which has a strong presence in both sterile injectables and biosimilars. Overall, I see Pfizer as well positioned both financially and strategically to continue delivering value to patients and shareholders.”

Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am very pleased with our financial results to date in 2015. During third-quarter 2015, we were able to grow revenues by

operationally, excluding the impact of foreign exchange and legacy Hospira operations, despite the continued significant negative impact from product losses of exclusivity, primarily Celebrex and Zyvox in the U.S. and Lyrica in certain developed Europe markets.

“We raised our 2015 financial guidance for reported revenues

to reflect the strong performance to date of Pfizer-standalone (excluding legacy Hospira) operations coupled with an improved business outlook for Pfizer-standalone

for the remainder of the year. Changes in foreign exchange rates since mid-July 2015 did not materially impact our updated guidance. Additionally, we updated our 2015 financial guidance ranges for adjusted cost of sales

as a percentage of reported revenues

, adjusted SI&A expenses

adjusted R&D expenses

and reported diluted EPS

to reflect the anticipated impact of legacy Hospira operations from September 3, 2015 through fiscal year-end 2015

as well as the impact of Pfizer-standalone operations. For the remainder of 2015 and into 2016, we expect to continue to advance the Hospira integration while remaining focused on delivering strong operating results.”

QUARTERLY FINANCIAL HIGHLIGHTS (

Reported revenues

decreased

$274 million

, which reflects operational growth of

$795 million

, more than offset by the unfavorable impact of foreign exchange of

$1.1 billion

. Excluding the impact of legacy Hospira operations and foreign exchange, Pfizer-standalone reported revenues

increased by

$465 million

operationally, or

Operational revenue growth in developed markets was driven primarily by the performance of several key products, including Prevnar 13 in adults, Ibrance and Eliquis -- all products that are early in their life cycles -- as well as from Lyrica primarily in the U.S., and the inclusion of one month of legacy Hospira U.S. operations.

In emerging markets, revenues increased

operationally, reflecting continued strong operational growth, primarily from the Innovative Products business.

Operational revenue growth was partially offset primarily by the loss of exclusivity and associated generic competition for Celebrex in the U.S., Zyvox in the U.S. and Lyrica in certain developed Europe markets.

Innovative Products Business Highlights

Revenues for the Innovative Products business increased

operationally, reflecting the following:

primarily due to the strong operational performance of Eliquis globally, Lyrica primarily in the U.S., Enbrel in most international markets as well as Xeljanz and Viagra, both primarily in the U.S.

Operational growth was partially offset by generic competition for Rapamune in the U.S., which began in October 2014.

operationally.

Revenues in the U.S. increased

driven by continued strong uptake of Prevnar 13 among adults due to the success of commercial programs and increased demand in preparation for the upcoming flu season. International revenues increased

operationally, primarily driven by Prevenar 13, which grew

operationally, primarily in emerging markets compared with the year-ago quarter

primarily due to Nexium 24HR

in the U.S. driven by increased demand and lower revenues in third-quarter 2014 as retailers reduced initial stocking levels following the May 2014 launch

operationally, primarily driven by continued strong momentum following the February 2015 U.S. launch of Ibrance for advanced breast cancer and, to a lesser extent, stronger demand for Sutent, Xalkori and Inlyta in most markets

Established Products Business Highlights

primarily due to the loss of exclusivity and associated launch of multi-source generic competition for Celebrex in the U.S. in December 2014

, for Zyvox in the U.S. beginning in first-half 2015

and for Lyrica in certain developed Europe markets beginning in first-quarter 2015.

These declines were partially offset by the inclusion of one month of legacy Hospira U.S. operations, which contributed

$330 million

, and growth in emerging markets, where revenues increased

Income Statement Highlights

Adjusted cost of sales

and adjusted R&D expenses

in the aggregate increased

$380 million

, reflecting the following operational factors:

higher adjusted cost of sales

, primarily reflecting the inclusion of one month of legacy Hospira U.S. operations in

and an increase in sales volume, partially offset by a decrease in royalty expense and manufacturing efficiencies;

higher adjusted SI&A expense

, primarily reflecting increased investments to support recently launched products and certain other in-line products as well as the inclusion of one month of legacy Hospira U.S. operations in

, partially offset by lower expenses associated with certain products that have recently lost marketing exclusivity, as well as continued benefits from cost-reduction and productivity initiatives; and

lower adjusted R&D expense

, primarily due to the non-recurrence of upfront payments associated with certain agreements entered into during third-quarter 2014, partially offset by higher clinical trial spend for certain oncology and GIP

pipeline programs as well as the inclusion of one month of legacy Hospira U.S. operations in

The effective tax rate on adjusted income

declined

percentage point to

. This decline was primarily due to an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years with various foreign tax authorities, partially offset by an unfavorable change in the jurisdictional mix of earnings.

The diluted weighted-average shares outstanding declined by

160 million

shares compared to the prior-year quarter due to Pfizer’s share repurchase program, including the impact of the $5 billion accelerated share repurchase agreement executed in February 2015 and completed in July 2015.

In addition to the aforementioned factors,

reported earnings were primarily impacted by the following:

Unfavorable impacts:

higher purchase accounting adjustments, restructuring charges and acquisition-related costs primarily associated with the acquisition of Hospira in

higher asset impairment charges in

, including an impairment loss related to Pfizer's 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China.

Favorable impacts:

the non-recurrence of a charge incurred in the prior-year quarter for an additional year of the Branded Prescription Drug Fee in accordance with final regulations issued in third-quarter 2014 by the U.S. Internal Revenue Service; and

a lower effective tax rate, primarily due to an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years with various foreign tax authorities and the non-recurrence in 2015 of the non-tax deductible charge for the aforementioned additional year of the Branded Prescription Drug Fee incurred in the prior-year quarter, partially offset by the unfavorable change in the jurisdictional mix of earnings.

RECENT NOTABLE DEVELOPMENTS

Product Developments

Ibrance (palbociclib)

Pfizer announced in August 2015 that the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for palbociclib in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The submission was based on the final results of the PALOMA-1 and PALOMA-3 trials in metastatic breast cancer. Both trials demonstrated that palbociclib in combination with an endocrine therapy improved progression-free survival compared to endocrine therapy alone.

Pfizer, with Alliance Foundation Trials, LLC and the Austrian Breast & Colorectal Cancer Study Group, announced in August 2015 the launch of the Palbociclib Collaborative Adjuvant Study, or PALLAS. This global Phase 3 clinical trial for patients with early-stage breast cancer is being conducted in conjunction with Breast International Group, German Breast Group, National Surgical Adjuvant Breast and Bowel Project and PrECOG, LLC. The PALLAS trial is designed to evaluate whether the addition of palbociclib to standard therapy will improve disease-free survival and prevent the disease from recurring. Approximately 4,600 people are expected to enroll in the trial.

Trumenba (rLP2086, Meningococcal Serogroup B Bivalent Recombinant Lipoprotein vaccine)

Pfizer announced in August 2015 positive topline results of two Phase 3 studies of Trumenba. One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain

invasive meningococcal B strains after the vaccine dose series. Safety and tolerability data from both studies were also consistent with data from previous studies.

Pfizer presented in October 2015 data from a randomized, controlled Phase 2 study of Trumenba, coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines in adolescents. The data, which were released in an oral presentation at IDWeek 2015 in San Diego, are based on a study conducted in more than 2,600 healthy individuals 10 through 12 years of age that evaluated the safety, tolerability and immunogenicity of Trumenba when coadministered with MCV4 and Tdap. Data demonstrated that immune responses following Trumenba, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or Trumenba alone.

Xeljanz (tofacitinib citrate)

Pfizer announced in October 2015 that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The FDA's recommendations are specific to the moderate to severe chronic plaque psoriasis sNDA.

Pfizer regularly reviews the Xeljanz development portfolio and recently decided not to advance indications for Crohn’s disease and ankylosing spondylitis. Pfizer will focus its future investments and development programs on indications for rheumatoid arthritis (RA), psoriatic arthritis and ulcerative colitis (UC). Pfizer also has a broad developmental portfolio of other Janus kinase (JAK) inhibitors and new mechanisms of action in inflammation and immunology.

Pfizer intends to re-submit a MAA to the EMA for Xeljanz for the treatment of moderate to severe active RA by first-quarter 2016. The re-submission will include additional safety results and analyses requested by the Agency following the initial review and subsequent discussions, intended to strengthen the characterization of the benefit-risk profile.

Pfizer announced in September 2015 positive top-line results from two of its four Phase 3 studies of Xeljanz (tofacitinib 10 mg, twice daily tablets) for the treatment of adults with moderate to severe UC. Both studies met their primary endpoints as measured by the proportion of patients receiving Xeljanz in remission at week 8 compared to patients receiving placebo. No new or unexpected safety findings for Xeljanz were observed in the studies. Detailed analyses of these induction studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting. The two remaining studies in the Phase 3 UC program are ongoing.

Pfizer announced in July 2015 that the FDA accepted for review Pfizer’s new drug application (NDA) for Xeljanz 11 mg once daily modified release tablets for the treatment of patients with moderate to severe RA who have had an inadequate response or intolerance to methotrexate. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016.

Xalkori (crizotinib)

-- In October 2015, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending extension of the current indication of Xalkori to include first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. This recommendation is based on efficacy and safety data from the Phase 3 PROFILE 1014 trial that supports Xalkori as a standard of care in the first-line setting for patients with ALK-positive advanced NSCLC. In Europe, Xalkori is currently indicated for the treatment of adults with previously treated ALK-positive advanced NSCLC.

Eliquis (apixaban)

Bristol-Myers Squibb Company (BMS) and Pfizer presented new data for Eliquis at the ESC Congress 2015 in August and September 2015. The new data reinforce the commitment of the BMS-Pfizer alliance to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism patient populations. In addition, data from the AEGEAN (Assessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study evaluating adherence among NVAF patients further extends the BMS-Pfizer alliance’s commitment to patient care.

BMS and Pfizer announced in September 2015 that the first patient has been enrolled into a Phase 4 clinical trial, AUGUSTUS, designed to evaluate the safety of Eliquis versus warfarin or other vitamin K antagonists in patients with NVAF and a recent acute coronary syndrome or undergoing percutaneous coronary intervention, also known as a stent. AUGUSTUS is anticipated to enroll 4,600 patients from 30 countries, and is one of several new clinical trials that will help provide additional information on the safe and appropriate use of Eliquis for certain types of patients within currently approved indications.

Pipeline Developments

A comprehensive update of Pfizer's development pipeline, including assets from the recently-completed Hospira acquisition, 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

(MSB0010718C)

Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer announced in October 2015 that the FDA granted avelumab

, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. The designation relates to the clinical development program for avelumab

in metastatic MCC, which includes the Phase 2 study, JAVELIN Merkel 200, to assess the safety and efficacy of avelumab

in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen.

Merck KGaA and Pfizer announced in September 2015 that the FDA granted orphan drug designation for avelumab

for the treatment of MCC.

Merck KGaA and Pfizer presented in September 2015 data from six studies evaluating the...


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