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PFIZER REPORTS FIRST-QUARTER 2016 RESULTS

May 3, 2016 6:45 AM

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter 2016 and updated certain components of its 2016 financial guidance.

On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, first-quarter 2016 financial results include three months of legacy Hospira global operations while first-quarter 2015 financial results do not include any contribution from legacy Hospira operations.

The Company manages its commercial operations through two distinct businesses: an Innovative Products(3) business and an Established Products(3) business. The Innovative Products(3) business is composed of two operating segments: the Global Innovative Pharmaceutical segment (GIP) and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC). The Established Products(3) business consists of the Global Established Pharmaceutical segment (GEP), which includes all legacy Hospira commercial operations. Financial results for each of these segments are presented in the Operating Segment Information section.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange as well as the negative currency impact related to Venezuela. Results for first-quarter 2016 and 2015 are summarized below.

OVERALL RESULTS
($ in millions, except

per share amounts)

First-Quarter
2016 2015 Change
Reported Revenues(1) $ 13,005 $ 10,864 20%
Adjusted Income(2) 4,155 3,196 30%
Adjusted Diluted EPS(2) 0.67 0.51 32%
Reported Net Income(1) 3,016 2,376 27%
Reported Diluted EPS(1) 0.49 0.38 29%
REVENUES
($ in millions) First-Quarter
2016 2015 % Change
Total Oper.
Innovative Products(3) $ 7,033 $ 5,738 23% 28%
GIP 3,640 3,075 18% 25%
Global Vaccines 1,570 1,328 18% 22%
Global Oncology 1,001 528 90% 95%
Consumer Healthcare 822 808 2% 10%
Established Products(3)(4) $ 5,972 $ 5,125 17% 24%
GEP(4) Standalone 4,773 5,125 (7%) 1%
Legacy Hospira 1,199 * *
Total Company $ 13,005 $ 10,864 20% 26%
Pfizer Standalone

(Excl. Legacy Hospira)

$ 11,806 $ 10,864 9% 15%

* Indicates calculation not meaningful.

SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)
($ in millions)

(Favorable)/Unfavorable

First-Quarter
2016 2015

% Change

Total Oper.
Cost of Sales(2) $ 2,565 $ 1,807 42% 45%
Percent of Revenues(1) 19.7 % 16.6 % N/A N/A
SI&A Expenses(2) 3,368 3,078 9% 14%
R&D Expenses(2) 1,723 1,877 (8%) (8%)
Total $ 7,656 $ 6,762 13% 16%
Effective Tax Rate(2) 23.8 % 24.4 %

2016 FINANCIAL GUIDANCE(5)

The ranges for certain components of Pfizer's 2016 financial guidance have been updated today as set forth below, primarily reflecting the following:

Pfizer's complete 2016 financial guidance, including today's updates, is summarized below:

Reported Revenues(1) $51.0 to $53.0 billion
(previously $49.0 to $51.0 billion)
Adjusted Cost of Sales(2) as a Percentage of Reported Revenues(1) 21.0% to 22.0%
Adjusted SI&A Expenses(2) $13.7 to $14.7 billion
(previously $13.2 to $14.2 billion)
Adjusted R&D Expenses(2) $7.4 to $7.8 billion
(previously $7.3 to $7.8 billion)
Adjusted Other (Income)/Deductions(2) Approximately ($500 million) of income
(previously approx. ($300 million) of income)
Effective Tax Rate on Adjusted Income(2) Approximately 24.0%
Reported Diluted EPS(1) $1.72 to $1.85
(previously $1.54 to $1.67)
Adjusted Diluted EPS(2) $2.38 to $2.48
(previously $2.20 to $2.30)

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, “We began the year with very strong operational performance across both our Innovative and Established businesses and this has served as a key driver of an increase in both our revenue and earnings per share guidance for the remainder of the year. I believe this performance results from our Company being well positioned in terms of product portfolio, organizational structure and leadership, as well as by our continued strong financial flexibility. In addition, our late stage product pipeline is increasingly ready to deliver our next set of prospective growth drivers with competitive positions in high-potential therapeutic areas where I believe Pfizer can be a leader.

“In addition, we have made excellent progress integrating the legacy Hospira operations and now expect to achieve $1.0 billion of Hospira cost savings by 2018, 25% more than our initial cost savings target of $800 million. Overall, we remain focused on delivering continued revenue growth both through internal and external opportunities, managing an efficient operating structure and making shareholder-friendly capital allocation and business portfolio decisions,” Mr. Read concluded.

Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am very pleased with our first-quarter 2016 financial results and with our ability to continue delivering shareholder value through prudent capital allocation. We grew revenues by 15% operationally, excluding the impact of foreign exchange and legacy Hospira operations. We also continued to deliver significant value directly to shareholders by paying $1.9 billion in first-quarter 2016 dividends and executing a $5 billion accelerated share repurchase agreement in March 2016.

“We raised our 2016 financial guidance for reported revenues(1) and adjusted diluted EPS(2) to reflect the strong operational performance to date coupled with an improved business outlook for 2016. Changes in foreign exchange rates since mid-January 2016 also favorably impacted our updated guidance. For the remainder of 2016, we expect to continue to advance the Hospira integration while remaining focused on delivering strong operating results,” Mr. D'Amelio concluded.

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

Reported revenues(1) totaled $13.0 billion, an increase of $2.1 billion, or 20%, which reflects operational growth of $2.9 billion, or 26%, partially offset by the unfavorable impact of foreign exchange of $729 million, or 7%. Excluding the impact of legacy Hospira operations of $1.2 billion and foreign exchange, Pfizer-standalone revenues increased by $1.7 billion operationally, or 15%. Compared with the prior-year quarter, first-quarter 2016 revenues were favorably impacted by approximately $900 million as a result of first-quarter 2016 having five additional selling days in the U.S. and four additional selling days in international markets. This imbalance in selling days will be offset in fourth-quarter 2016 resulting in essentially the same number of selling days in full-year 2016 as 2015.

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 Ibrance, Prevnar 13, Eliquis, Xeljanz and Lyrica -- all primarily in the U.S. In emerging markets, revenues increased 14% operationally, favorably impacted by the addition of legacy Hospira operations, which contributed $78 million, as well as the performance of Enbrel, Prevenar 13 and continued strong volume growth from certain other products.

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

Innovative Products(3) Business Highlights

Revenues for the Innovative Products(3) business increased 28% operationally, reflecting the following:

Established Products(3)(4) Business Highlights

Income Statement Highlights

RECENT NOTABLE DEVELOPMENTS

Product Developments

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.

Corporate Developments

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/Q1_2016_PFE_Earnings_Press_Release_nvewlnavd.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 in the Adjusted income section of Pfizer’s 2015 Financial Report, which was filed as Exhibit 13 to Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We have included Adjusted income, certain components of Adjusted income, and Adjusted diluted EPS in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines, consumer healthcare (OTC) products, and vaccines––prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for first-quarter 2016 and 2015, 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)

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 2015 Financial Report, which was filed as Exhibit 13 to Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015.

(4) Effective as of the beginning of 2016, Pfizer's entire contract manufacturing business, Pfizer CentreOne, is now part of GEP. Pfizer CentreOne consists of (i) the revenues and expenses of legacy Pfizer's contract manufacturing and active pharmaceutical ingredient sales operation, including the revenues and expenses related to our manufacturing and supply agreements with Zoetis Inc. (collectively Pfizer CentreSource or PCS); and (ii) the revenues and expenses of legacy Hospira's One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside of our operating segments as part of Pfizer Global Supply and reported as "Other Business Activities". Prior period PCS operating results have been reclassified to conform to the current period presentation as part of GEP. The legacy Hospira One-2-One contract manufacturing business has been a part of GEP commencing from the acquisition date of September 3, 2015.
(5) The 2016 financial guidance reflects the following:
($ in billions, except per share amounts)
Income/(Expense) Net Income Diluted EPS
Adjusted income/diluted EPS(2) guidance $14.7 - $15.3 $2.38 - $2.48
Purchase accounting impacts of transactions completed as of April 3, 2016 (2.9) (0.47)
Restructuring, implementation and other acquisition-related costs (0.7) - (0.9) (0.11) - (0.14)
Business and legal entity alignment costs (0.3) (0.05)
Reported net income attributable to Pfizer Inc./diluted EPS(1) guidance $10.6 - $11.4 $1.72 - $1.85
(6) The following are certain product categories within GEP(4):

Definitions for all GEP(4) product categories can be found in the footnotes to the product revenue tables on page 26 of the press release located at the hyperlink referred to above.

(7) Remicade is a registered U.S. trademark of Janssen Biotech, Inc.

DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 3, 2016. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.

This earnings release and the related attachments contain forward-looking statements about our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from our recent acquisition of Hospira 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:

We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors should bear this in mind as they consider forward-looking statements, and are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors”, and in our subsequent reports on Form 8-K.

The operating segment information provided in this earnings release and the related attachments does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented.

This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.

Pfizer Inc.

Media

Joan Campion, 212-733-2798

or

Investors

Chuck Triano, 212-733-3901

or Ryan Crowe, 212-733-8160

or Bryan Dunn, 212-733-8917

Source: Pfizer Inc.

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