Quantcast
Channel: New-York – EEI-BIOTECHFINANCES
Viewing all articles
Browse latest Browse all 1030

PFIZER REPORTS FIRST-QUARTER 2016 RESULTS

$
0
0
Tuesday, May 3rd 2016 at 10:45am UTC
  • First-Quarter 2016 Reported Revenues(1) of $13.0 Billion,
    Reflecting 26% Operational Growth Driven by 28% Operational Growth
    from the Innovative Products Business and the Inclusion of Legacy
    Hospira Operations
  • First-Quarter 2016 Reported Revenues(1) for Pfizer
    Standalone (Excluding Legacy Hospira) of $11.8 Billion, Reflecting 15%
    Operational Growth
  • First-Quarter 2016 Adjusted Diluted EPS(2) of $0.67,
    Reported Diluted EPS(1) of $0.49
  • Raised Midpoint of 2016 Financial Guidance Ranges for Reported Revenues(1)
    by $2.0 Billion and Adjusted Diluted EPS(2) by $0.18,
    Reflecting Strong Performance to Date and Improved Outlook for 2016 as
    well as Favorable Impact of Recent Changes in Foreign Exchange Rates

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:

  • Operational Factors: Strong performance to date coupled with an
    improved business outlook for 2016, which favorably impacted the
    midpoint of the guidance range for reported revenue(1) by
    approximately $1.0 billion and for reported(1) and adjusted(2)
    diluted EPS by $0.12.
  • Foreign Exchange: Favorable changes in foreign exchange rates since
    mid-January 2016, which favorably impacted the midpoint of the
    guidance range for reported revenue(1) by approximately
    $1.0 billion and for reported(1) and adjusted(2)
    diluted EPS by $0.06.

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:

  • GIP revenues increased 25% operationally, primarily due to strong
    operational growth from Eliquis globally, Lyrica and Xeljanz both
    primarily in the U.S., Enbrel in most international markets and
    Chantix primarily in the U.S. Operational growth was slightly offset
    by the expiration of the collaboration agreement to co-promote Rebif
    in the U.S., which expired at the end of 2015.
  • VOC revenues increased 33% operationally, reflecting the following:
    • Global Vaccines revenues increased 22% operationally, driven by
      growth from Prevnar 13, primarily in the U.S., reflecting the
      timing of government purchases for the pediatric indication and
      continued strong uptake among adults due to the overall success of
      commercial programs.
    • Global Oncology revenues increased 95% 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 in most markets.
    • Consumer Healthcare revenues increased 10% operationally,
      primarily due to Nexium 24HR and Advil, both in the U.S.,
      reflecting strong demand following increased promotion and the
      launch of a tablet form for Nexium 24HR in first-quarter 2016.

Established Products(3)(4) Business
Highlights

  • GEP(4) revenues increased 24% 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 certain Peri-LOE Products(6),
    primarily Zyvox in the U.S. and certain developed Europe markets as
    well as Lyrica in certain developed Europe markets. Revenues excluding
    the contribution from the legacy Hospira portfolio (GEP(4)
    Standalone) increased 1% operationally, reflecting 7% operational
    growth from Legacy Established Products(6) and 11%
    operational growth from the Sterile Injectable Pharmaceuticals(6)
    portfolio, partially offset by an 18% operational decline from
    Peri-LOE Products(6). GEP(4) revenues in
    emerging markets increased 10% operationally, driven by the inclusion
    of legacy Hospira operations and reflecting operational growth from
    Legacy Established Products(6) and the GEP(4)
    Standalone Sterile Injectable Pharmaceuticals(6) portfolio.


Income Statement Highlights

  • Adjusted cost of sales(2), adjusted SI&A expenses(2)
    and adjusted R&D expenses(2) in the aggregate increased
    $1.1 billion operationally, or 16%, reflecting the inclusion of legacy
    Hospira operations in first-quarter 2016 and the following
    Pfizer-standalone operational factors:
    • higher adjusted cost of sales(2) primarily due to
      higher sales volumes;
    • higher adjusted SI&A expense(2), primarily
      reflecting higher general and administrative expenses as well as
      increased investments to support certain recently launched
      products and other in-line biopharmaceutical products; and
    • lower adjusted R&D expense(2), primarily reflecting
      the non-recurrence of a $295 million upfront payment to OPKO
      Health, Inc. in first-quarter 2015 associated with a worldwide
      development and commercialization agreement.
  • The effective tax rate on adjusted income(2) declined 0.6
    percentage points to 23.8% from 24.4%. This decline was primarily due
    to a favorable change in the jurisdictional mix of earnings, an
    increase in tax benefits associated with the resolution of certain tax
    positions pertaining to prior years with various foreign tax
    authorities, as well as an increase in tax benefits due to the
    permanent extension of the U.S. R&D tax credit on December 18, 2015.
  • The diluted weighted-average shares outstanding declined by 78 million
    shares compared to the prior-year quarter due to Pfizer’s share
    repurchase program, including the impact of a $5 billion accelerated
    share repurchase agreement executed in February 2015 and completed in
    July 2015 and another reduction of 136 million shares associated with
    an accelerated share repurchase agreement executed in March 2016.
  • In addition to the aforementioned factors, first-quarter 2016 reported
    earnings were primarily impacted by the following:

    Favorable
    impacts:

    • a lower effective tax rate, primarily due to tax benefits related
      to the final resolution (pending court approval) of an agreement
      in principle reached in February 2016 to resolve certain claims
      related to Protonix and tax benefits associated with our Venezuela
      operations, partially offset by an unfavorable change in the
      jurisdictional mix of earnings; and
    • lower charges incurred during first-quarter 2016 for business and
      legal entity alignment activities compared with the prior-year
      quarter.


    Unfavorable impacts:

    • higher acquisition-related costs, legal charges and purchase
      accounting adjustments in first-quarter 2016 compared with the
      prior-year quarter; and
    • higher asset impairment charges associated with losses on certain
      equity-method investments in first-quarter 2016.


RECENT NOTABLE DEVELOPMENTS

Product Developments

  • Chantix/Champix (varenicline) — In April 2016, Pfizer
    announced publication in The Lancet of results from the largest
    clinical trial of approved smoking cessation medicines, called EAGLES
    (Evaluating Adverse Events in a Global Smoking Cessation Study). This
    smoking cessation trial included 8,144 adult smokers and was designed
    to compare the neuropsychiatric safety of Chantix/Champix
    (varenicline) and bupropion with placebo and nicotine patch in adult
    smokers with and without a history of psychiatric disorders. The
    authors concluded that the trial did not show a significant increase
    in serious neuropsychiatric adverse events with Chantix/Champix or
    bupropion compared to placebo and nicotine patch. There were more
    neuropsychiatric adverse events in the psychiatric cohort than the
    non-psychiatric cohort across all treatment arms including placebo.
    Results also showed that smokers treated with Chantix/Champix had
    significantly higher quit rates than those treated with bupropion,
    nicotine patch or placebo. Full results of the EAGLES trial were
    published in The Lancet on April 22, 2016.
  • Ibrance (palbociclib)
    • In April 2016, Pfizer announced positive top-line results from the
      Phase 3 PALOMA-2 trial for Ibrance. The study met its primary
      endpoint by demonstrating an improvement in progression-free
      survival (PFS) for the combination of Ibrance plus letrozole
      compared with letrozole plus placebo in post-menopausal women with
      estrogen receptor-positive, human epidermal growth factor receptor
      2-negative (HER2-) advanced or metastatic breast cancer who had
      not received previous systemic treatment for their advanced
      disease. The PALOMA-2 trial provides confirmatory evidence for
      Ibrance in combination with letrozole in the first-line setting,
      which was first studied in the Phase 2 PALOMA-1 trial. These data
      will support additional planned global regulatory submissions and
      a request for conversion of the accelerated approval for Ibrance
      to regular approval in the U.S. Detailed efficacy and safety
      results from the PALOMA-2 trial will be presented at the American
      Society of Clinical Oncology (ASCO) 2016 Annual Meeting.
    • Pfizer announced in February 2016 that the U.S. Food and Drug
      Administration (FDA) approved a supplemental New Drug Application
      (sNDA) expanding the use of Ibrance 125 mg capsules to include the
      treatment of hormone receptor-positive, HER2- advanced or
      metastatic breast cancer in combination with fulvestrant in women
      with disease progression following endocrine therapy.
  • Inflectra (infliximab-dyyb) — In April 2016, the FDA approved
    Celltrion’s Inflectra (infliximab-dyyb) across all eligible
    indications of the reference product, Remicade(7)
    (infliximab). Inflectra is now the first and only biosimilar
    monoclonal antibody therapy to be approved in the U.S. Hospira, now a
    Pfizer company, entered into an agreement with Celltrion Inc. and
    Celltrion Healthcare, Co., Ltd. in 2009 for several potential
    biosimilar products, including Inflectra. As a result, Pfizer holds
    exclusive commercialization rights to Inflectra in the U.S.
  • Xalkori (crizotinib) — Pfizer announced in March 2016 that the
    FDA approved a sNDA for Xalkori to treat patients with metastatic
    non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
    Additionally, the European Medicines Agency (EMA) is reviewing an
    application to extend the marketing authorization of Xalkori to
    include the treatment of adult patients with ROS1-positive advanced
    NSCLC.
  • Xeljanz (tofacitinib citrate)
    • Pfizer announced in April 2016 top-line results from its first
      Phase 3 study investigating tofacitinib for the treatment of
      psoriatic arthritis (PsA), Oral Psoriatic Arthritis triaL (OPAL)
      Broaden. This study evaluated the efficacy and safety of
      tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients
      with active PsA who had an inadequate response to at least one
      conventional synthetic disease-modifying antirheumatic drug and
      who were tumor necrosis factor inhibitor-naïve. OPAL Broaden met
      its primary efficacy endpoints demonstrating that both tofacitinib
      5 mg BID and 10 mg BID were superior to treatment with placebo at
      3 months as measured by American College of Rheumatology 20
      response and Health Assessment Questionnaire Disability Index
      score. Overall safety findings in this study were consistent with
      those observed in the broader rheumatology clinical development
      program for tofacitinib.
    • In March 2016, Pfizer announced that the EMA has accepted for
      review the Marketing Authorization Application for Xeljanz 5 mg
      tablets twice daily for the treatment of patients with moderate to
      severe rheumatoid arthritis (RA) who have had an inadequate
      response or intolerance to methotrexate (MTX).
    • In February 2016, Pfizer announced that the FDA has approved
      Xeljanz XR extended-release 11 mg tablets for the once-daily
      treatment of moderate to severe RA in patients who have had an
      inadequate response or intolerance to MTX. Xeljanz XR is the first
      and only once-daily oral RA treatment in its class, known as Janus
      kinase (JAK) inhibitors.


Pipeline Developments

A comprehensive update of Pfizer’s development pipeline was published
today and is now available at www.pfizer.com/pipeline.
It includes an overview of Pfizer’s research and a list of compounds in
development with targeted indication and phase of development, as well
as mechanism of action for candidates from Phase 2 through registration.

  • Avelumab (MSB0010718C) — Merck KGaA, Darmstadt, Germany (Merck
    KGaA) and Pfizer announced in April 2016 the treatment of the first
    patient in a Phase 3 study of avelumab, an investigational fully human
    anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell
    carcinoma (RCC) setting. The study, JAVELIN Renal 101, is the first
    pivotal trial investigating avelumab in combination with Inlyta
    (axitinib), Pfizer’s tyrosine kinase inhibitor (TKI), in patients with
    previously untreated advanced RCC, and the only Phase 3 trial
    currently evaluating an anti-PD-L1 immunotherapy in combination with a
    vascular endothelial growth factor-receptor TKI in this setting.
    JAVELIN Renal 101 is a multicenter, international, randomized (1:1),
    open-label trial designed to evaluate the potential superiority,
    assessed by PFS, of first-line avelumab combined with Inlyta compared
    with Sutent (sunitinib malate) monotherapy, Pfizer’s oral,
    small-molecule, multi-targeted receptor TKI, in patients with
    unresectable, locally advanced or metastatic RCC with clear cell
    component. The study is expected to enroll 583 patients across
    approximately 170 sites in Asia, Europe, Latin America and North
    America.
  • Bococizumab (PF-04950615, RN316)
    • Pfizer announced in April 2016 the completion of patient
      enrollment for the global SPIRE-2 cardiovascular outcome trial for
      bococizumab, an investigational Proprotein Convertase Subtilisin
      Kexin type 9 inhibitor (PCSK9i). SPIRE-2 is evaluating the
      efficacy and safety of bococizumab compared to placebo in reducing
      the risk of major cardiovascular events among 10,600 patients at
      high risk for cardiovascular disease – including those without a
      prior history of cardiovascular events – who are on
      highly-effective statins or with documented statin intolerance.
      Many factors impact the duration of cardiovascular outcome
      studies, including that they are time-to-event trials, which can
      make it difficult to predict when the studies will accrue the
      required number of events. Based on current estimates, the SPIRE-2
      study is expected to complete in the second half of 2017.
    • In April 2016, Pfizer announced positive top-line results from the
      second of six Phase 3 studies evaluating the low-density
      lipoprotein cholesterol (LDL-C) reduction activity of bococizumab.
      The SPIRE-AI (AutoInjector) trial of bococizumab administered with
      a pre-filled pen met its co-primary endpoints: percent change from
      baseline in LDL-C reduction at 12 weeks compared to placebo and
      proportion of patients successfully operating the pre-filled pen.
      The results of the SPIRE-AI trial are expected to be part of a
      potential regulatory filing for bococizumab.


Corporate Developments

  • In April 2016, Pfizer announced that the merger agreement between
    Pfizer and Allergan plc (Allergan) entered into on November 22, 2015
    was terminated by mutual agreement of the companies. The decision was
    driven by the actions announced by the U.S. Department of Treasury on
    April 4, 2016, which the companies concluded qualified as an “Adverse
    Tax Law Change” under the merger agreement. In connection with the
    termination of the merger agreement, on April 8, 2016 (which falls
    into Pfizer’s second fiscal quarter), Pfizer paid Allergan $150
    million for reimbursement of Allergan’s expenses associated with the
    terminated transaction.
  • Pfizer announced in March 2016 that it entered into an accelerated
    share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to
    repurchase $5 billion of Pfizer’s common stock. Pursuant to the terms
    of the agreement, on March 10, 2016, Pfizer paid $5 billion to GS&Co.
    and received an initial delivery of approximately 136 million shares
    of Pfizer common stock from GS&Co. At settlement of the agreement,
    which is expected to occur during the second quarter of 2016, GS&Co.
    may be required to deliver additional shares of common stock to
    Pfizer, or, under certain circumstances, Pfizer may be required to
    deliver shares of its common stock or may elect to make a cash payment
    to GS&Co., with the number of shares to be delivered or the amount of
    such payment based on the volume-weighted average price, less a
    discount, of Pfizer’s common stock during the term of the transaction.
  • Pfizer reported in February 2016 that its Wyeth subsidiary reached an
    agreement in principle to resolve claims alleging that Wyeth’s
    practices relating to the calculation of Medicaid rebates for its drug
    Protonix (pantoprazole sodium) between 2001 and 2006, several years
    before Pfizer acquired Wyeth in 2009, violated the Federal Civil False
    Claims Act and other laws. As a result, in February 2016, Pfizer
    reissued its fourth-quarter and full-year 2015 financial results
    prepared in accordance with U.S. generally accepted accounting
    principles (GAAP) to reflect a charge of $784.6 million. In April
    2016, this agreement was finalized and Wyeth made a payment of this
    amount to resolve these claims. The final agreement is subject to
    court approval and does not include an admission of liability by
    Wyeth. As previously mentioned, a tax benefit related to this
    resolution was recorded in Pfizer’s first-quarter 2016 GAAP financial
    results.

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:
  • Does not assume the completion of any business development
    transactions not completed as of April 3, 2016, including any one-time
    upfront payments associated with such transactions.
  • Excludes the potential effects of the resolution of litigation-related
    matters not substantially resolved as of April 3, 2016.
  • Exchange rates assumed are a blend of the actual exchange rates in
    effect during first-quarter 2016 and mid-April 2016 exchange rates for
    the remainder of the year.
  • 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 $1.3 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
    $0.10, including $0.07 due to the estimated significant negative
    currency impact related to Venezuela.
  • Guidance for reported(1) and adjusted(2) diluted
    EPS 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 $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):
  • Peri-LOE Products include products that have recently lost or are
    anticipated to soon lose patent protection. These products primarily
    include Celebrex and Zyvox in most developed markets, Lyrica in
    certain developed Europe markets, Pristiq globally and Inspra in the
    EU.
  • Sterile Injectable Pharmaceuticals include generic injectables and
    proprietary specialty injectables (excluding Peri-LOE Products).
  • Legacy Established Products include products that lost patent
    protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE
    Products).
     

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:

  • the outcome of research and development activities, including, without
    limitation, the ability to meet anticipated pre-clinical and clinical
    trial commencement and completion dates, regulatory submission and
    approval dates, and launch dates for product candidates, as well as
    the possibility of unfavorable pre-clinical and clinical trial
    results, including unfavorable new clinical data and additional
    analyses of existing clinical data;
  • decisions by regulatory authorities regarding whether and when to
    approve our drug applications, which will depend on the assessment by
    such regulatory authorities of the benefit-risk profile suggested by
    the totality of the efficacy and safety information submitted;
    decisions by regulatory authorities regarding labeling, ingredients
    and other matters that could affect the availability or commercial
    potential of our products; and uncertainties regarding our ability to
    address the comments in complete response letters received by us with
    respect to certain of our drug applications to the satisfaction of the
    FDA;
  • the speed with which regulatory authorizations, pricing approvals and
    product launches may be achieved;
  • the outcome of post-approval clinical trials, which could result in
    the loss of marketing approval for a product or changes in the
    labeling for, and/or increased or new concerns about the safety or
    efficacy of, a product that could affect its availability or
    commercial potential;
  • risks associated with interim data, including the risk that final
    results of studies for which interim data have been provided and/or
    additional clinical trials may be different from (including less
    favorable than) the interim data results and may not support further
    clinical development of the applicable product candidate or indication;
  • the success of external business-development activities, including the
    ability to satisfy the conditions to closing of any announced
    transactions in the anticipated time frame or at all;
  • competitive developments, including the impact on our competitive
    position of new product entrants, in-line branded products, generic
    products, private label products and product candidates that treat
    diseases and conditions similar to those treated by our in-line drugs
    and drug candidates;
  • the implementation by the FDA and regulatory authorities in certain
    other countries of an abbreviated legal pathway to approve biosimilar
    products, which could subject our biologic products to competition
    from biosimilar products, with attendant competitive pressures, after
    the expiration of any applicable exclusivity period and patent rights;
  • the ability to meet generic and branded competition after the loss of
    patent protection for our products or competitor products;
  • the ability to successfully market both new and existing products
    domestically and internationally;
  • difficulties or delays in manufacturing;
  • trade buying patterns;
  • the impact of existing and future legislation and regulatory
    provisions on product exclusivity;
  • trends toward managed care and healthcare cost containment;
  • the impact of any significant spending reductions or cost controls
    affecting Medicare, Medicaid or other publicly funded or subsidized
    health programs or changes in the tax treatment of employer-sponsored
    health insurance that may be implemented, and/or any significant
    additional taxes or fees that may be imposed on the pharmaceutical
    industry as part of any broad deficit-reduction effort;
  • the impact of U.S. healthcare legislation enacted in 2010—the Patient
    Protection and Affordable Care Act, as amended by the Health Care and
    Education Reconciliation Act—and of any modification, repeal or
    invalidation of any of the provisions thereof;
  • U.S. federal or state legislation or regulatory action affecting,
    among other things, pharmaceutical product pricing, reimbursement or
    access, including under Medicaid, Medicare and other publicly funded
    or subsidized health programs; the importation of prescription drugs
    from outside the U.S. at prices that are regulated by governments of
    various foreign countries; restrictions on direct-to-consumer
    advertising; limitations on interactions with healthcare
    professionals; or the use of comparative effectiveness methodologies
    that could be implemented in a manner that focuses primarily on the
    cost differences and minimizes the therapeutic differences among
    pharmaceutical products and restricts access to innovative medicines;
    as well as pricing pressures for our products as a result of highly
    competitive insurance markets;
  • legislation or regulatory action in markets outside the U.S. affecting
    pharmaceutical product pricing, reimbursement or access, including, in
    particular, continued government-mandated reductions in prices and
    access restrictions for certain biopharmaceutical products to control
    costs in those markets;
  • the exposure of our operations outside the U.S. to possible capital
    and exchange controls, expropriation and other restrictive government
    actions, changes in intellectual property legal protections and
    remedies, as well as political unrest,unstable governments and legal
    systems and inter-governmental disputes;
  • contingencies related to actual or alleged environmental contamination;
  • claims and concerns that may arise regarding the safety or efficacy of
    in-line products and product candidates;
  • any significant breakdown, infiltration or interruption of our
    information technology systems and infrastructure;
  • legal defense costs, insurance expenses, settlement costs, the risk of
    an adverse decision or settlement and the adequacy of reserves related
    to product liability, patent matters, government investigations,
    consumer, commercial, securities, antitrust, environmental,
    employment, tax issues, ongoing efforts to explore various means for
    resolving asbestos litigation, and other legal proceedings;
  • our ability to protect our patents and other intellectual property,
    both domestically and internationally;
  • interest rate and foreign currency exchange rate fluctuations,
    including the impact of possible currency devaluations in countries
    experiencing high inflation rates;
  • 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;
  • the risk of an impairment charge related to our intangible assets,
    goodwill or equity-method investments;
  • risks related to internal control over financial reporting; and
  • risks and uncertainties related to our recent 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.

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.

Contacts

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.

Cet article PFIZER REPORTS FIRST-QUARTER 2016 RESULTS est apparu en premier sur EEI-BIOTECHFINANCES.


Viewing all articles
Browse latest Browse all 1030

Trending Articles