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Pfizer, Inc.$43.80($.77)(1.73%)

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 PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2015 RESULTS
   Tuesday, February 02, 2016 6:45:02 AM ET

--Fourth-Quarter 2015 Reported Revenues(1) of $14.0 Billion, Reflecting 14% Operational Growth Driven by 22% Operational Growth from the Innovative Products Business

--Full-Year 2015 Reported Revenues(1) of $48.9 Billion, Reflecting 6% Operational Growth Driven by 19% Operational Growth from the Innovative Products Business

--Fourth-Quarter 2015 Adjusted Diluted EPS(2) of $0.53 and Reported Diluted EPS(1) of $0.10; Full-Year 2015 Adjusted Diluted EPS(2) of $2.20 and Reported Diluted EPS(1) of $1.24

--Provides 2016 Financial Guidance

Pfizer Inc. (PFE ) reported financial results for fourth-quarter and full-year 2015 and provided 2016 financial guidance.

On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, and in accordance with Pfizer’s domestic and international reporting periods(3), full-year financial results for the year ended December 31, 2015 reflect four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations, while financial results from fourth-quarter 2014 and full-year 2014 do not include any contribution from legacy Hospira operations. Fourth-quarter 2015 includes three months of legacy Hospira global 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)(4) and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC)(4). The Established Products business consists of the Global Established Pharmaceutical segment (GEP)(4), 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 fourth-quarter and full-year 2015 and 2014 are summarized below.

OVERALL RESULTS
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($ in millions, except                                                                                                                                                                                                                           Fourth-Quarter                                                                                                                                                                                                                                                                                                                                                                         Full-Year
per share amounts)
                                                                                                                     ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------                                                                                    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                        2015                                                                                                                      2014                                                                                                              Change                                                                                                                                                                           2015                                                                                                                        2014                                                                                         Change
                                                                                                                     ------------------------------------------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------- -----------------------------------------------------------------------------------------------                                                               ------------------------------------------------------------------------------------------------------------------------------------------------------ --------------------------------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------
Reported Revenues(1)                                                                                                                                                                              $ 14,047                                                                                                                              $ 13,118                                                                      7%                                                                                                                                                                                                                  $ 48,851                                                                                                             $ 49,605                                                        (2%)
Adjusted Income(2)                                                                                                                                                                                   3,306                                                                                                                                                    3,441                                                                                        (4%)                                                                                                                                                                                                                   13,755                                                                                                                                  14,530                                                                           (5%)
Adjusted Diluted EPS(2)                                                                                                                                                                               0.53                                                                                                                                                     0.54                                                                                        (2%)                                                                                                                                                                                                                     2.20                                                                                                                                    2.26                                                                           (3%)
Reported Net Income(1)                                                                                                                                                                                 613                                                                                                                                                    1,228                                                                                        (50%)                                                                                                                                                                                                                   7,745                                                                                                                                   9,135                                                                           (15%)
Reported Diluted EPS(1)                                                                                                                      0.10                                                                                                               0.19                                                  (47%)                                                                                                                                                           1.24                                                                                              1.42                                     (13%)
----------------------------------------------------- -------------------- -------------------- -------------------- ---------------------------------------------------------------------------------------------------------- -------------------- ----------------------------------------------------------------------------------------------------------------------------------- -------------------- ------------------------------------------------------------------------------------------------------------------- -------------------- -------------------- --------------------------------------------------------------------------------------------------------------------------------- -------------------- ------------------------------------------------------------------------------------------------------------------ -------------------- ---------------------------------------------------------------------
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
REVENUES                                                     
----------------------------------------------------- -------------------- -------------------- -------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
($ in millions)                                                                                                                                                                                                                                                                                Fourth-Quarter                                                                                                                                                                                                                                                                                                                                                                                                                                  Full-Year
                                                                                                                     ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------                                                               ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                       2015                                                                2014                                                                                                                                             % Change                                                                                                                                                                                     2015                                                                             2014                                                                                                                                  % Change
                                                                                                                                                                                                                                                                                                                    --------------------------------------------------------------------------------------------------------------------------------------------------------------------                                                                                                                                                                                                                                                                                         ---------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                                                 Total                                                                Oper.                                                                                                                      Total                                                                   Oper.
                                                                                                                     -------------------------------------   --------------------------------------------------------------------------------------------------------------------------------- -------------------- --------------------                                                 -------------------- -------------------- -------------------- ---------------------------------------------------------------------------------------------------------------------------------------- -------------------- --------------------                                           ------------------------------------------------------------------
Innovative Products                                                                                                             $ 7,637                                                                                                                           $ 6,628                                                                                                 15%                                                              22%                                                                                                                         $ 26,758                                                                                                         $ 24,005                                                                                          11%                                                           19%
  GIP(4)                                                                                                                          3,862                                                                                                                             3,748                                                                                                 3%                                                                                                     10%                                                                                                                           13,954                                                                                                           13,861                                                                                          1%                                                                                                  9%
  Global Vaccines(4)                                                                                                              1,917                                                                                                                             1,318                                                                                                 45%                                                                                                    53%                                                                                                                            6,454                                                                                                            4,480                                                                                          44%                                                                                                 51%
  Consumer Healthcare(4)                                                                                                            930                                                                                                                               953                                                                                                (2%)                                                                                                    4%                                                                                                                             3,395                                                                                                            3,446                                                                                         (1%)                                                                                                 5%
  Global Oncology(4)                                                                                                                928                                                                      609                                                           52%                                                              61%                                                                                                                            2,954                                                   2,218                                                    33%                                                           43%
                                                                                                                     --------------------------------------- -------------------- -------------------- --------------------------------------------------------------------------------------- -------------------- ----------------------------------------------------------------------------------------------------------------------------------- -------------------- ----------                                                                ----------------------------------------------------------------------------------- -------------------- -------------------- ---------------------------------------------------------------------- -------------------- -------------------------------------------------------------------------------------------------------------------- -------------------- --------------------
Established Products                                                                                                            $ 6,264                                                                                                                           $ 6,407                                                                                                (2%)                                                                                                    5%                                                                                                                          $ 21,587                                                                                                         $ 25,149                                                                                         (14%)                                                                                               (7%)
  GEP(4) Standalone                                                                                                               5,082                                                                                                                             6,407                                                                                                (21%)                                                                                                  (14%)                                                                                                                          20,075                                                                                                           25,149                                                                                         (20%)                                                                                               (13%)
  Legacy Hospira                                                                                                                  1,182                                                           --                                                            *                                                                *                                                                                                                             1,513                                          --                                                     *                                                             *
                                                                                                                     --------------------------------------- -------------------- -------------------- --------------------------------------------------------------------------------------- -------------------- ----------------------------------------------------------------------------------------------------------------------------------- -------------------- ----------                                                                ----------------------------------------------------------------------------------- -------------------- -------------------- ---------------------------------------------------------------------- -------------------- -------------------------------------------------------------------------------------------------------------------- -------------------- --------------------
Other(5)                                                                                                                            146                                                                       83                                                           75%                                                              98%                                                                                                                              506                                                     451                                                    12%                                                           20%
                                                                                                                     --------------------------------------- -------------------- -------------------- --------------------------------------------------------------------------------------- -------------------- ----------------------------------------------------------------------------------------------------------------------------------- -------------------- ----------                                                                ----------------------------------------------------------------------------------- -------------------- -------------------- ---------------------------------------------------------------------- -------------------- -------------------------------------------------------------------------------------------------------------------- -------------------- --------------------
    Total Company                                                                                                              $ 14,047                                                                 $ 13,118                                                           7%                                                               14%                                                                                                                         $ 48,851                                                $ 49,605                                                   (2%)                                                           6%
                                                                                                                     ======================================= ==================== ==================== ======================================================================================= ==================== =================================================================================================================================== ==================== ==========                                                                =================================================================================== ==================== ==================== ====================================================================== ==================== ==================================================================================================================== ==================== ====================
                                                                                                                      
Pfizer Excluding Legacy                                               $ 12,865                                                                 $ 13,118                                                          (2%)                                                              5%                                                                 $ 47,339                                                $ 49,605                                                   (5%)                                                           3%
Hospira
----------------------------------------------------- -------------------- -------------------- -------------------- -----------------  -------------------- -------------------- -------------------- ---------------------------------------------------------------    -------------------- -------------------- ---------------------------------------------------------------------------------------------------------      -------------------- -------------------- ---------- -------------------- -------------------- -------------------- ------------------------------------------------------------   -------------------- -------------------- -------------------- ----------------------------------------------    -------------------- -------------------- ------------------------------------------------------------------------------------------      -------------------- -------------------- --------------------
* Indicates calculation not meaningful.
                                                                                                                      
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)        
----------------------------------------------------- -------------------- -------------------- -------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
($ in millions)                                                                                                                                                                                                                                                                                           Fourth-Quarter                                                                                                                                                                                                                                                                                                                                                                                                                                  Full-Year
(Favorable)/Unfavorable
                                                                                                                     ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------                                                                                    ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                       2015                                                                                                                           2014                                                                                                                                    % Change                                                                                                                                                                2015                                                                                                                              2014                                                                                                               % Change
                                                                                                                                                                                                                                                                                                                                                              -----------------------------------------------------------------------------------------------------------------------------------------------                                                                                                                                                                                                                                                                                                              ---------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                            Total                                                      Oper.                                                                                                           Total                                              Oper.
                                                                                                                     -------------------------------------   --------------------------------------------------------------------------------------- -------------------- ------------------------------------------                                                -------------------- -------------------- -------------------- ---------------------------------------------------------------------------------------------- -------------------- -------------------- ------------------------------------------------------------                                             ----------------------------------------------------------------------------------------------------------
Cost of Sales(2)                                                                                                     $ 2,983                                                                                                                                                           $ 2,584                                                                                                 15%                                                                                          22%                                                                                          $ 9,021                                                                                                                                                    $ 9,134                                                                                         (1%)                                                                            10%
  Percent of Revenues(1)                                                                                                21.2 %                                                                                                                                                            19.7 %                                                                            N/A                                                                                          N/A                                                                                             18.5 %                                                                                                                                                     18.4 %                                                                     N/A                                                                            N/A
SI&A Expenses(2)                                                                                                       4,598                                                                                                                                                             3,916                                                                                                 17%                                                                                          24%                                                                                           14,324                                                                                                                                                     13,721                                                                                          4%                                                                             11%
R&D Expenses(2)                                                                                                        2,318                                                                                                    2,039                                        14%                                                    16%                                                                                            7,653                                                                                             7,153                                 7%                                       9%
                                                                                                                     ------- ---------------------------------------------------- -------------------- ------------------------------------------------------------------------------------------------------------ -------------------- -------------------- ----------------------------------------------------------------------------------------- -------------------- --------------------------------                                                               -------------------- -------------------------------------------------------------- -------------------- ------------------------------------------------------------------------------------------- -------------------- -------------------- -------------------------------------------------------------------------- -------------------- --------------------
  Total                                                                                                              $ 9,900                                                                                                  $ 8,539                                        16%                                                    21%                                                                                         $ 30,998                                                                                          $ 30,007                                 3%                                       10%
                                                                                                                     ======= ==================================================== ==================== ============================================================================================================ ==================== ==================== ========================================================================================= ==================== ================================                                                               ==================== ============================================================== ==================== =========================================================================================== ==================== ==================== ========================================================================== ==================== ====================
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
Effective Tax Rate(2)                                          19.6 %                                                                                                                      26.2 %                                                                                                                 24.0 %                                                                                                               26.5 %                                                                
----------------------------------------------------- -------------------- -------------------- -------------------- ------- ------------------------------  -------------------- -------------------- -----------------------------------------------------------------------------------     -------------------- -------------------- -------------------- -----------------------------------------------------------------    -------------------- -------------------- ------------------------------  -------------------- -------------------- -------------------- -------------------- ----------------------------------------  -------------------- -------------------- ------------------------------------------------------------------     -------------------- -------------------- -------------------- --------------------------------------------------    -------------------- -------------------- --------------------
 

2016 FINANCIAL GUIDANCE(6)

A reconciliation of Pfizer’s full-year 2015 financial results to certain components of its 2016 financial guidance is below. For 2016, the financial guidance includes the estimated significant negative currency impact related to Venezuela and excludes any impact from the pending combination with Allergan plc (Allergan).

 
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                                                                                     Impact of Mid-                              
                                                                                                                                                                                                       January 2016 FX                                                                                         
                                                                                                                                                            2016 Financial                                                Rates Compared                                               Currency Impact                                               
                                                                                                                  Full-Year                                                   Guidance at 2015                                              to 2015 FX Rates                                                Related to                                                    2016 Financial
                 2015 Results                FX Rates             (Ex Venezuela)            Venezuela                 Guidance
----------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ---------------------- -------------------- -------------------- ---------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------------------
                                                                                                                                                                                                                                                                                                                                                                       
Reported Revenues(1)                $48.9 billion        $51.3 to $53.3 billion      ($1.5 billion)         ($0.8 billion)        $49.0 to $51.0 billion
----------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ---------------------- -------------------- -------------------- ---------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------------------
Reported Diluted EPS(1)                 $1.24                $1.70 to $1.83              ($0.09)                ($0.07)               $1.54 to $1.67
----------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ---------------------- -------------------- -------------------- ---------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------------------
Adjusted Diluted EPS(2)                 $2.20                $2.36 to $2.46              ($0.09)                ($0.07)               $2.20 to $2.30
----------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- -------------------- ---------------------- -------------------- -------------------- ---------------- -------------------- -------------------- -------------------- -------------------- -------------------- ----------------------
 

Pfizer’s complete 2016 financial guidance is summarized below.

 
------------------------------------------------------------------------------------------------------------------------------------------------------------
Reported Revenues(1)                                                $49.0 to $51.0 billion
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Adjusted Cost of Sales(2) as a Percentage of Reported                   21.0% to 22.0%
Revenues(1)
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Adjusted SI&A Expenses(2)                                           $13.2 to $14.2 billion
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Adjusted R&D Expenses(2)                                             $7.3 to $7.8 billion
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Adjusted Other (Income)/Deductions(2)                       Approximately ($300 million) of income
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Effective Tax Rate on Adjusted Income(2)                              Approximately 24.0%
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Reported Diluted EPS(1)                                                 $1.54 to $1.67
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
Adjusted Diluted EPS(2)                                                 $2.20 to $2.30
----------------------------------------------------- -------------------- -------------------- -------------------- --------------------------------------
 

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, "The just completed year was very productive in terms of business momentum, pipeline advancement and business development activity. I am particularly pleased with the performance of our Prevnar 13 adult and Ibrance launches in the U.S. In addition, Eliquis, Xeljanz and the Hospira portfolio, among other assets, along with operational growth in emerging markets, meaningfully enhanced the strength of our businesses.

"I believe that we are well positioned to deliver another strong year in 2016 as we expect that our key in-line products will continue to perform well while we expect to advance our product pipeline, notably our potential registrational programs in key therapeutic areas such as oncology, vaccines, cardiovascular and metabolic diseases, inflammation and rare diseases."

Mr. Read continued, "The integration of Hospira is well underway and we now look forward to completing the combination with Allergan, which we still expect to occur during the second half of this year. We see this transaction as a very effective driver of accelerating the growth potential of our Innovative business, strengthening our Established business and more efficiently allocating our capital globally, all factors which remain consistent with our overarching strategy of value creation.

"I want to thank our colleagues for their continued tireless work in an environment, that while challenging, continues to be very rewarding for our stakeholders," Mr. Read concluded.

Frank D’Amelio, Chief Financial Officer, stated, "2015 was a truly transformational year for Pfizer. In addition to our strong financial performance, we completed the Hospira acquisition, announced the pending combination with Allergan and continued to deliver shareholder value through prudent capital allocation. Regarding our financial performance, we exceeded our 2015 financial guidance for reported revenue(1) and met the top end of our 2015 financial guidance range for adjusted diluted EPS(2) despite an operating environment that remains challenging. Importantly, Pfizer-standalone revenues increased 3% operationally, marking Pfizer’s first year of operational revenue growth since entering a period of significant product losses of exclusivity. We believe the completion of the Hospira acquisition and the pending Allergan combination will strengthen our core businesses and better position the Company for sustainable revenue growth in the future.

"Today we are also providing our 2016 financial guidance, including ranges for reported revenues(1) of $49.0 to $51.0 billion and for adjusted diluted EPS(2) of $2.20 to $2.30. Our guidance for reported revenues(1) reflects anticipated mid-to-high-single digit operational revenue growth on an enterprise basis offset by the anticipated negative impact of $2.3 billion due to generic competition for products that recently lost or are expected to soon lose marketing exclusivity as well as $2.3 billion as a result of adverse changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from last year, including $0.8 billion due to the estimated significant currency impact related to Venezuela. Our 2016 financial guidance excludes any impact from the pending combination with Allergan. Finally, our guidance for reported(1) and adjusted(2) diluted EPS also reflects anticipated share repurchases totaling $5 billion this year, consisting of our previously-announced plans to enter into a $5 billion accelerated share repurchase agreement that we expect to execute in the first half of 2016. These planned repurchases are expected to more than offset the potential dilution related to employee compensation programs," Mr. D’Amelio concluded.

QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2015 vs. Fourth-Quarter 2014)

Reported revenues(1) totaled $14.0 billion, an increase of $930 million, or 7%, which reflects operational growth of $1.9 billion, or 14%, partially offset by the unfavorable impact of foreign exchange of $934 million, or 7%. Excluding the impact of legacy Hospira operations of $1.2 billion, foreign exchange and, to a lesser extent, the vaccines acquired from Baxter International Inc. (Baxter) of $35 million, Pfizer-standalone revenues increased by $646 million operationally, or 5%.

Operational revenue growth in developed markets was driven primarily by the inclusion of $1.1 billion of revenues from legacy Hospira operations and continued strong performance of several key products, notably Prevnar 13 in adults and Ibrance in the U.S., Eliquis globally as well as Xeljanz and Lyrica primarily in the U.S. In emerging markets, revenues increased 5% operationally, favorably impacted by the addition of legacy Hospira operations, which contributed $73 million, as well as the performance of Prevenar 13 and certain other products.

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

Innovative Products Business Highlights

Revenues for the Innovative Products business increased 22% operationally, reflecting the following:

-- GIP(4) revenues increased 10% operationally, primarily due to the strong operational performance of Eliquis globally, Lyrica in the U.S. and Japan as well as Xeljanz primarily in the U.S.

-- VOC(4) revenues increased 38% operationally, reflecting the following:

-- Global Vaccines(4) revenues increased 53% operationally, driven by 102% growth of Prevnar 13 in the U.S., reflecting continued strong uptake among adults due to the continued success of commercial programs and increased demand during the flu season as well as by the timing of government purchases for the pediatric indication compared to the year-ago quarter.

-- Global Oncology(4) revenues increased 61% 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 and Xalkori globally.

-- Consumer Healthcare(4) revenues increased 4% operationally, primarily due to Nexium 24HR in the U.S., driven by strong demand following increased promotion and lower revenues in fourth-quarter 2014 as retailers reduced initial stocking levels following the May 2014 launch.

Established Products Business Highlights

-- GEP(4) revenues increased 5% operationally due to the inclusion of legacy Hospira operations, which contributed $1.2 billion, partially offset by the loss of exclusivity and associated generic competition for Celebrex in the U.S. and certain other developed markets, Lyrica in certain developed Europe markets and Zyvox in the U.S. Emerging markets revenues were flat operationally, driven by the inclusion of legacy Hospira operations and continued strong growth in China offset by declines in certain Middle East markets.

Income Statement Highlights

-- Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $1.8 billion operationally, or 21%, reflecting the inclusion of legacy Hospira operations in fourth-quarter 2015 and the following Pfizer-standalone operational factors:

-- slightly lower adjusted cost of sales(2);

-- higher adjusted SI&A expense(2), primarily reflecting increased investments to support recently launched products, other in-line biopharmaceutical products and certain Consumer Healthcare brands; and

-- higher adjusted R&D expense(2), primarily due to incremental investments in certain late-stage pipeline programs.

-- The effective tax rate on adjusted income(2) declined 6.6 percentage points to 19.6% from 26.2%. This decline was primarily due to a favorable change in the jurisdictional mix of earnings as well as an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years primarily with various foreign tax authorities.

-- The diluted weighted-average shares outstanding declined by 125 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, fourth-quarter 2015 reported earnings were primarily impacted by the following: Unfavorable impacts: -- foreign currency losses related to Venezuela;

-- higher purchase accounting adjustments, acquisition-related costs, restructuring charges and asset impairment charges in fourth-quarter 2015 compared with the prior year quarter; and

-- non-recurring charges related to pension settlements.

Favorable impacts:

-- the non-recurrence of a charge associated with a collaborative arrangement with Merck KGaA, Darmstadt, Germany (Merck KGaA), announced in November 2014, to jointly develop and commercialize avelumab(7);

-- lower charges for certain legal matters, primarily the non-recurrence of a charge to resolve a securities class action in New York federal court that was incurred in the prior year quarter; and

-- a lower effective tax rate, primarily due to the aforementioned factors impacting the fourth-quarter 2015 effective tax rate on adjusted income(2) as well as benefits associated with certain tax initiatives, partially offset by the non-tax deductible charge for the aforementioned foreign currency losses related to Venezuela.

FULL-YEAR FINANCIAL HIGHLIGHTS (Full-Year 2015 vs. Full-Year 2014)

Reported revenues(1) decreased $754 million, or 2%, which reflects operational growth of $3.0 billion, or 6%, more than offset by the unfavorable impact of foreign exchange of $3.8 billion, or 8%. Excluding the impact of legacy Hospira operations of $1.5 billion, foreign exchange and, to a lesser extent, the vaccines acquired from Baxter of $178 million, Pfizer-standalone revenues increased by $1.3 billion operationally, or 3%, which reflects operational revenue growth from certain key products partially offset by product losses of exclusivity and co-promotion expirations that negatively impacted 2015 reported revenues(1) by $3.2 billion operationally.

Income Statement Highlights

-- Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $3.0 billion operationally, or 10%, reflecting the inclusion of legacy Hospira operations from September 2015 and the following Pfizer-standalone operational factors: -- higher adjusted cost of sales(2), primarily reflecting an increase in sales volume, partially offset by manufacturing efficiencies and a decrease in royalty expense associated with products that recently lost marketing exclusivity;

-- higher adjusted SI&A expense(2), primarily reflecting increased investments to support recently launched products, other in-line biopharmaceutical products and certain Consumer Healthcare brands, partially offset by lower expenses associated with certain products that have recently lost marketing exclusivity, continued benefits from cost-reduction and productivity initiatives as well as a lower cost for the Branded Prescription Drug Fee compared to the prior year; and

-- higher adjusted R&D expense(2), primarily due to higher clinical trial spend for certain oncology and GIP(4) pipeline programs, an upfront payment to OPKO Health, Inc. in first-quarter 2015 associated with a worldwide development and commercialization agreement and increased investment in biosimilar and sterile injectable development programs, partially offset by the non-recurrence of upfront payments associated with certain agreements entered into during third-quarter 2014.

-- The full-year 2015 effective tax rate on adjusted income(2) declined 2.5 percentage points to 24.0% from 26.5% in 2014. This decline was primarily due to a favorable change in the jurisdictional mix of earnings.

-- The diluted weighted-average shares outstanding declined by 167 million shares compared to the prior-year, primarily 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 full-year 2015 factors and the factors impacting fourth-quarter 2015 reported earnings, full-year 2015 reported earnings were primarily impacted by the following: Unfavorable impacts: -- higher acquisition-related costs, purchase accounting adjustments and restructuring charges, all primarily associated with the acquisition of Hospira in third-quarter 2015;

-- higher asset impairment charges, including an impairment loss related to Pfizer’s 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China recorded in third-quarter 2015; and

-- higher charges incurred during 2015 for business and legal entity alignment activities.

Favorable impacts:

-- lower legal charges, primarily as a result of the non-recurrence of the aforementioned charge to resolve a securities class action recorded in fourth-quarter 2014 and the non-recurrence of a charge to resolve Neurontin-related matters recorded in first-quarter 2014;

-- lower implementation costs associated with restructuring activities and amortization expense related to intangible assets;

-- the non-recurrence of a charge incurred in third-quarter 2014 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 the aforementioned factors impacting the fourth-quarter and full-year 2015 effective tax rate as well as the non-recurrence in 2015 of the non-tax deductible charge for the aforementioned additional year of the Branded Prescription Drug Fee incurred in third-quarter 2014.

RECENT NOTABLE DEVELOPMENTS

Product Developments

-- Eliquis (apixaban) -- Bristol-Myers Squibb Company (BMS) and Pfizer announced in December 2015 results from a post-hoc early time course subanalysis of the Phase 3 AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy) trial. The subanalysis demonstrated Eliquis was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin dose-adjusted to an international normalized ratio of 2.0 to 3.0) in recurrent venous thromboembolism (VTE) and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment. The results of the subanalyses at each pre-specified time interval were consistent with the overall results of the AMPLIFY trial at six months.

-- In November 2015, BMS and Pfizer presented 22 abstracts at the American Heart Association (AHA) Scientific Sessions 2015. The new data, including four oral presentations, contribute to the BMS and Pfizer Alliance’s research in nonvalvular atrial fibrillation and VTE in patients treated with Eliquis. Abstracts included new data analyses from the pivotal Phase 3 study, ARISTOTLE, as well as a number of real-world data analyses.

-- Ibrance (palbociclib) -- Pfizer announced in December 2015 that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Ibrance. If approved, the sNDA would expand the approved use of Ibrance to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated Ibrance in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.

-- Lyrica (pregabalin) -- Pfizer announced in November 2015 top-line results of a Phase 3 study evaluating the efficacy and safety of Lyrica Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain. The study did not meet its primary efficacy endpoint. The study was conducted as a 15-week, double-blind, placebo-controlled, parallel group study with a primary objective to evaluate the efficacy of pregabalin in the treatment of chronic post-traumatic peripheral neuropathic pain. The primary efficacy endpoint was mean pain reduction from baseline compared with placebo based on pain scores from patients’ daily pain diaries. The safety profile observed in this study was consistent with that known for pregabalin. The most common adverse events with pregabalin in this study were dizziness, somnolence, nausea and fatigue. There is currently no treatment approved by the FDA for post-traumatic neuropathic pain.

-- Xalkori (crizotinib)

-- In December 2015, the FDA accepted and granted Priority Review for a sNDA for Xalkori for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, Xalkori received Breakthrough Therapy designation by the FDA for this potential indication. If approved, Xalkori would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC. Xalkori is currently indicated in the U.S. for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The PDUFA goal date for a decision by the FDA is April 2016.

-- Pfizer announced in November 2015 that the European Commission (EC) approved a label update to expand use of Xalkori to first-line treatment of adults with ALK-positive advanced NSCLC. The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that Xalkori significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.

-- In November 2015, Pfizer announced that PROFILE 1029, a Phase 3 study of Xalkori met its primary objective of significantly prolonging PFS in previously untreated East Asian patients with ALK-positive advanced NSCLC when compared to a standard chemotherapy doublet. In this study, Xalkori was used as the first systemic therapy for patients with advanced ALK-positive NSCLC, and patients could have received therapy and/or surgery for early stage disease before they were diagnosed with metastatic disease. The adverse events observed with Xalkori in the study were generally consistent with findings from previous trials. No unexpected adverse events were observed. Efficacy and safety data from PROFILE 1029 will be submitted for presentation at a future medical meeting.

-- Xeljanz (tofacitinib citrate) -- Pfizer presented in November 2015 26 new scientific abstracts, including 20 presentations for Xeljanz in rheumatoid arthritis (RA) at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting. The new data continue to characterize the safety and efficacy of Xeljanz in the treatment of RA.

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) -- The FDA has not taken action on Pfizer’s New Drug Application (NDA) for ALO-02, which had a PDUFA date in January 2016. The delay is not related to anything specific in the ALO-02 NDA, and no additional data analyses or data requests have been identified by the FDA. Pfizer is continuing discussions with the FDA to finalize the label. Pfizer cannot speculate on timing for the FDA decision.

-- Avelumab(7) (MSB0010718C)

-- Merck KGaA and Pfizer announced during fourth-quarter 2015 the initiation of five Phase 3 trials of avelumab(7), an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in various cancers, including:

-- JAVELIN Lung 100 is designed to assess the safety and efficacy of avelumab(7), compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer.

-- JAVELIN Gastric 100 is designed to compare the switch from first-line chemotherapy to maintenance therapy with avelumab(7) versus continuation of chemotherapy in patients with unresectable, locally advanced or metastatic gastric/gastro-esophageal junction cancers whose disease has not progressed with first-line platinum-based chemotherapy.

-- JAVELIN Gastric 300 is designed to evaluate the superiority (based on overall survival) of avelumab(7) in patients with unresectable, recurrent or metastatic gastric/gastro-esophageal junction cancers, compared with investigator’s choice of chemotherapy from a pre-specified list of therapeutic options.

-- JAVELIN Ovarian 200 is designed to evaluate the superiority of avelumab(7) as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, in treating patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase 3 study of a PD-L1 inhibitor investigated in this setting.

-- JAVELIN Bladder 100 is designed to evaluate the safety and efficacy of avelumab(7) plus best supportive care (BSC) as a maintenance treatment, compared with BSC alone, in patients with unresectable, locally advanced or metastatic urothelial cancer whose disease did not progress on (or following) completion of first-line treatment with a platinum-containing chemotherapy.

-- Merck KGaA and Pfizer announced in November 2015 that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion for Orphan Drug designation for avelumab(7) for the treatment of patients with Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. An official decision by the EC was granted in December 2015.

-- Merck KGaA and Pfizer announced in November 2015 that the FDA granted Breakthrough Therapy designation for avelumab(7) for the treatment of patients with metastatic MCC who have progressed after at least one previous chemotherapy regimen.

-- Merck KGaA and Pfizer announced in October 2015 that the FDA granted avelumab(7) Fast Track designation for the treatment of metastatic MCC.

-- Bococizumab (PF-04950615, RN316) -- In January 2016, Pfizer received positive top-line results from the first of six Phase 3 studies evaluating the low-density lipoprotein cholesterol (LDL-C) reduction activity of bococizumab. The SPIRE-SI study evaluated the efficacy, safety, and tolerability of bococizumab in adults with dyslipidemia who are intolerant to statins. A total of 184 patients were randomized to receive either 150 mg of bococizumab every two weeks by subcutaneous injection, atorvastatin 40 mg once-daily or placebo once-daily for 12 weeks. The trial met its primary endpoint, as measured by the percent change in baseline LDL-C level at 12 weeks. No new or unexpected safety findings for bococizumab were observed in the study. Complete study results of the SPIRE-SI trial will be presented at an upcoming scientific congress. Results from other Phase 3 studies evaluating LDL-C reduction are expected throughout 2016.

Corporate Developments

-- BMS and Pfizer announced in February 2016 that the companies have entered into a collaboration agreement with Portola Pharmaceuticals Inc. (Portola) to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis.

-- Pfizer announced in January 2016 an expansion of its R&D investment strategy to include early-stage companies on the leading edge of scientific innovation, providing them with both equity and access to resources for research in promising areas aligned with Pfizer’s core interests. The first four investments of the newly focused initiative include $46 million in financing to companies at early stages of the discovery process that are actively exploring Conditionally Active Biologics, immuno-oncology, neurodegenerative technologies and gene therapy. Additional opportunities will continue to be identified by Pfizer’s scientific leadership through their active involvement, and Pfizer will help recipient companies fully explore their platforms in the hopes of advancing new therapeutic pathways.

-- Pfizer and Adaptive Biotechnologies Corporation (Adaptive) announced in January 2016 that they have entered into a translational research collaboration to leverage next generation sequencing of the adaptive immune system to advance Pfizer’s growing immuno-oncology franchise. Under the terms of the agreement, Pfizer and Adaptive will seek to combine drug development and platform technology biomarker expertise to identify patients who may preferentially benefit from immunotherapy.

-- Merck KGaA, Pfizer and Syndax Pharmaceuticals, Inc. (Syndax) announced in January 2016 that they have entered into a collaboration agreement to evaluate avelumab(7) in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer. This is an exclusive agreement between the Merck KGaA-Pfizer alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase 1b/2 clinical trial.

-- In December 2015, Pfizer announced that its Board of Directors declared a 30-cent first-quarter 2016 dividend on the Company’s common stock, payable March 2, 2016, to shareholders of record at the close of business on February 5, 2016. This represents an increase of 7% in the quarterly dividend per share, compared to 28 cents per share in first-quarter 2015.

-- In December 2015, the Board of Directors authorized a new $11 billion share repurchase program to be utilized over time. In November 2015, Pfizer announced that, consistent with 2015, it expects to execute an approximately $5 billion accelerated share repurchase program in the first half of 2016. As of December 31, 2015, Pfizer had $16.4 billion in aggregate remaining under its share repurchase authorizations.

-- In November 2015, Pfizer announced that it entered into a definitive merger agreement with Allergan, a global pharmaceutical company incorporated in Ireland, under which Pfizer agreed to combine with Allergan in a stock transaction valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015 (the last trading day prior to the announcement). Allergan shareholders will receive 11.3 shares of the combined company for each of their Allergan shares by virtue of a share split, and Pfizer stockholders will have the option of receiving one share of the combined company for some or all of their Pfizer shares or to receive cash instead of shares of the combined company for some or all of their Pfizer shares, provided that the aggregate amount of cash to be paid in the merger will not be less than $6 billion or greater than $12 billion. In the event that elections to receive cash and shares in the merger would otherwise result in an aggregate of less than $6 billion or greater than $12 billion of cash being paid out in the merger, then the share elections and cash elections will be subject to proration. The completion of the transaction, which is expected in the second half of 2016, is subject to certain conditions, including receipt of regulatory approval in certain jurisdictions, including the U.S. and EU, the receipt of necessary approvals from both Pfizer and Allergan shareholders, and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Industries Ltd. The merger agreement also provides that the businesses of Pfizer and Allergan will be combined under the existing Allergan entity, which, subject to approval by Allergan shareholders, will be renamed "Pfizer plc."

-- In response to the ongoing challenges patients face in paying their out-of-pocket costs for their prescription medicines, Pfizer announced in November 2015 that it has doubled the allowable income level for its patient assistance program, so that even more patients in need could be eligible to receive their Pfizer medicines for free. With this change, more than 40 medicines offered for free through the program are now available to eligible patients earning up to four times the Federal Poverty Level adjusted for family size ($47,080 for a single person; $97,000 for a family of four). Through the Pfizer RxPathways program, Pfizer offers patients, including those with health insurance and those without, a range of individual services to help them gain access to Pfizer medicines. From 2010 to 2014, Pfizer has helped nearly 2.5 million uninsured and underinsured patients get access to more than 30 million Pfizer prescriptions, making it the most comprehensive program of its kind.

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/Q4_2015_PFE_Earnings_Press_Release_asdkfsdaf.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.

(1)   Reported 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. Adjusted
                         revenue, 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 under Adjusted income in the Management’s Discussion and
                         Analysis of Financial Condition and Results of Operations section
                         of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter
                         ended September 27, 2015, management uses Adjusted income, among
                         other factors, to set performance goals and to measure the
                         performance of the overall company. We believe that investors’
                         understanding of our performance is enhanced by disclosing this
                         measure. See the accompanying reconciliations of certain GAAP
                         Reported to non-GAAP Adjusted information for the fourth quarter
                         and twelve months ended 2015 and 2014, as well as reconciliations
                         of full-year 2016 guidance for Adjusted income and Adjusted
                         diluted EPS to full-year 2016 guidance for Reported net income(1)
                         and Reported diluted EPS(1). 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)                      Pfizer’s fiscal year-end for international subsidiaries was November
                         30, 2015, and Pfizer’s fiscal year-end for U.S. subsidiaries was
                         December 31, 2015.
                          
(4)                      For a description of the revenues in each business, see the "Our
                         Strategy--Commercial Operations" sub-section in the Overview of
                         Our Performance, Operating Environment, Strategy and Outlook
                         section of Pfizer’s Quarterly Report on Form 10-Q for the fiscal
                         quarter ended September 27, 2015.
                          
(5)                      Other includes revenues from Pfizer CentreSource, our contract
                         manufacturing and bulk pharmaceutical chemical sales organization,
                         and revenues related to our manufacturing and supply agreements with
                         Zoetis Inc.
                          
(6)                      The 2016 financial guidance reflects the following:
                          

-- Does not assume the completion of any business development transactions not completed as of December 31, 2015, including any one-time upfront payments associated with such transactions. 2016 financial guidance excludes any impact from the pending combination with Allergan. The transaction is expected to close during the second half of 2016.

-- Excludes the potential effects of the resolution of litigation-related matters not substantially resolved as of December 31, 2015.

-- Exchange rates assumed are as of mid-January 2016.

-- Guidance for 2016 reported revenues(1) reflects the anticipated negative impact of $2.3 billion due to recent and expected generic competition for certain products that have recently lost or are anticipated to soon lose patent protection.

-- Guidance for 2016 reported revenues(1) also reflects the anticipated negative impact of $2.3 billion as a result of unfavorable changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2015, including $0.8 billion due to the estimated significant negative currency impact related to Venezuela. The anticipated negative impact on reported(1) and adjusted(2) diluted EPS resulting from unfavorable changes in foreign exchange rates compared to foreign exchange rates from 2015 is approximately $0.16, including $0.07 due to the estimated significant negative currency impact related to Venezuela.

-- Guidance for reported(1) and adjusted diluted EPS(2) assumes diluted weighted-average shares outstanding of approximately 6.2 billion shares.

-- Reconciliation of the 2016 Adjusted income(2) and Adjusted diluted EPS(2) guidance to the 2016 Reported net income attributable to Pfizer Inc.(1) and Reported diluted EPS attributable to Pfizer Inc.(1) common shareholders guidance:

 
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
($ in billions, except per share amounts)                                                     
Income/(Expense)                                                               Net Income         Diluted EPS
-------------------------------------------------------------------- -------------------- -------------------- -------------------- -------------------- ------------- -------------------- -------------------- ---------------
Adjusted income/diluted EPS(2) guidance                                                                                                                   $13.6 - $14.2                                            $2.20 - $2.30
Purchase accounting impacts of transactions completed as of December                                                                                          (2.8)                                                   (0.46)
31, 2015
Restructuring, implementation and other acquisition-related costs                                                                                         (0.7) - (0.9)                                           (0.11) - (0.14)
Business and legal entity alignment costs                                         (0.4)             (0.06)
-------------------------------------------------------------------- -------------------- -------------------- -------------------- -------------------- ------------- -------------------- -------------------- ---------------
Reported net income attributable to Pfizer Inc./diluted EPS(1)                $9.5 - $10.3       $1.54 - $1.67
guidance
-------------------------------------------------------------------- -------------------- -------------------- -------------------- -------------------- ------------- -------------------- -------------------- ---------------
 
(7)      Avelumab is the proposed International Nonproprietary Name for the
                            anti-PD-L1 monoclonal antibody, MSB0010718C.
 

DISCLOSURE NOTICE: The information contained in this earnings release and the attachments is as of February 2, 2016. We assume no obligation to update forward-looking statements contained in this earnings release and the attachments as a result of new information or future events or developments.

This earnings release and the 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 acquisition of Hospira, the pending combination with Allergan 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 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 timeframe 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;

-- 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 protection, government investigations, consumer, commercial, securities, antitrust, environmental and tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings;

-- our ability to protect our patents and other intellectual property, both domestically and internationally;

-- interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;

-- governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals;

-- any significant issues involving our largest wholesaler customers, which account for a substantial portion of our revenues;

-- the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines;

-- any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards;

-- any significant issues that may arise related to our joint ventures and other third-party business arrangements;

-- changes in U.S. generally accepted accounting principles;

-- uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; and the related risk that our allowance for doubtful accounts may not be adequate;

-- any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas;

-- growth in costs and expenses;

-- changes in our product, segment and geographic mix;

-- 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;

-- risks and uncertainties related to our recent acquisition of Hospira, including, among other things, the ability to realize the anticipated benefits of the acquisition of Hospira, including the possibility that expected synergies and accretion 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; and

-- risks and uncertainties related to our pending combination with Allergan, including, without limitation, the failure to obtain necessary regulatory approvals (and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the transaction) and shareholder approvals or to satisfy any of the other conditions to the transaction on a timely basis or at all, the occurrence of events that may give rise to a right of one or both of the parties to terminate the merger agreement, adverse effects on the market price of Pfizer’s common stock and on Pfizer’s operating results because of a failure to complete the transaction in the anticipated time frame or at all, failure to realize the expected benefits and synergies of the transaction, restructuring in connection with the transaction and subsequent integration of Pfizer and Allergan, negative effects of the announcement or the consummation of the transaction on the market price of Pfizer’s common stock and on Pfizer’s operating results, risks relating to the value of the Allergan shares to be issued in the transaction, significant transaction costs and/or unknown liabilities, the risk of litigation and/or regulatory actions, the loss of key senior management or scientific staff, general economic and business conditions that affect the companies following the transaction, changes in global, political, economic, business, competitive, market and regulatory forces, future exchange and interest rates, changes in tax and other laws, regulations, rates and policies, future business combinations or disposals, competitive developments and the uncertainties inherent in research and development.

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, 2014 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 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.

NO OFFER OR SOLICITATION

This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

This communication is not intended to be and is not a prospectus for the purposes of Part 23 of the Companies Act 2014 of Ireland (the "2014 Act"), Prospectus (Directive 2003/71/EC) Regulations 2005 (S.I. No. 324 of 2005) of Ireland (as amended from time to time) or the Prospectus Rules issued by the Central Bank of Ireland pursuant to section 1363 of the 2014 Act, and the Central Bank of Ireland ("CBI") has not approved this communication.

IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC

In connection with the pending combination between Pfizer Inc. ("Pfizer") and Allergan plc ("Allergan"), Allergan will file with the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-4 that will include a Joint Proxy Statement of Pfizer and Allergan that also constitutes a Prospectus of Allergan (the "Joint Proxy Statement/Prospectus"). Pfizer and Allergan plan to mail to their respective shareholders the definitive Joint Proxy Statement/Prospectus in connection with the transaction. INVESTORS AND SECURITY HOLDERS OF PFIZER AND ALLERGAN ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT PFIZER, ALLERGAN, THE TRANSACTION AND RELATED MATTERS. Investors and security holders will be able to obtain free copies of the Joint Proxy Statement/Prospectus (when available) and other documents filed with the SEC by Pfizer and Allergan through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the documents filed with the SEC by Pfizer by contacting Pfizer Investor Relations at Bryan.Dunn@pfizer.com or by calling (212) 733-8917, and will be able to obtain free copies of the documents filed with the SEC by Allergan by contacting Allergan Investor Relations at investor.relations@actavis.com or by calling (862) 261-7488.

PARTICIPANTS IN THE SOLICITATION

Pfizer, Allergan and certain of their respective directors, executive officers and employees may be considered participants in the solicitation of proxies in connection with the pending combination. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the respective shareholders of Pfizer and Allergan in connection with the pending combination, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Joint Proxy Statement/Prospectus when it is filed with the SEC. Information regarding Pfizer’s directors and executive officers is contained in Pfizer’s proxy statement for its 2015 annual meeting of stockholders, which was filed with the SEC on March 12, 2015, and certain of Pfizer’s Current Reports on Form 8-K. Information regarding Allergan’s directors and executive officers is contained in Allergan’s proxy statement for its 2015 annual meeting of shareholders, which was filed with the SEC on April 24, 2015, and certain of Allergan’s Current Reports on Form 8-K.

Statement Required by the Irish Takeover Rules

The directors of Pfizer accept responsibility for the information contained in this communication. To the best of the knowledge and belief of the directors of Pfizer (who have taken all reasonable care to ensure that such is the case), the information contained in this communication for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20160202005763r1&sid=cmtx6&distro=nx&lang=en

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SOURCE: Pfizer Inc.

Pfizer Inc. 
Media 
Joan Campion, 212-733-2798 
or 
Investors 
Chuck Triano, 212-733-3901 
Ryan Crowe, 212-733-8160 
Bryan Dunn, 212-733-8917


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