"Forward-Looking Information and Factors That May Affect Future Results"
(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter
2013 and updated certain components of its 2013 financial guidance to
reflect the impact of recent changes in foreign exchange rates and the
initial public offering (IPO) of a 19.8% ownership interest in Zoetis(1)
completed on February 6, 2013, among other factors. Pfizer continues to
consolidate Zoetis(1), as Pfizer retains an 80.2% ownership
interest. The earnings attributable to the divested interest in Zoetis(1)
(Net income attributable to noncontrolling interests) are
excluded from Adjusted(2) and Reported(3) Net
Income, effective February 7, 2013. Results and guidance are
summarized below.
|
OVERALL RESULTS |
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($ in millions, except
per share amounts) |
First-Quarter | |||||||||||
| 2013 | 2012 | % Change | ||||||||||
| Reported Revenues | $ | 13,500 | $ | 14,885 | (9 | %) | ||||||
| Adjusted Income(2) | 3,911 | 4,344 | (10 | %) | ||||||||
| Adjusted Diluted EPS(2) | 0.54 | 0.57 | (5 | %) | ||||||||
| Reported Net Income(3) | 2,750 | 1,794 | 53 | % | ||||||||
| Reported Diluted EPS(3) | 0.38 | 0.24 | 58 | % | ||||||||
|
BUSINESS UNIT(4) REVENUES |
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|
($ in millions)
Favorable/(Unfavorable) |
First-Quarter | |||||||||||||||
|
2013 |
2012 |
% Change | ||||||||||||||
|
Total |
Operational | |||||||||||||||
| Primary Care | $ | 3,238 | $ | 4,097 | (21 | %) | (20 | %) | ||||||||
| Specialty Care | 3,164 | 3,580 | (12 | %) | (11 | %) | ||||||||||
| Emerging Markets | 2,420 | 2,299 | 5 | % | 6 | % | ||||||||||
| Established Products | 2,352 | 2,801 | (16 | %) | (15 | %) | ||||||||||
| Zoetis(1) | 1,090 | 1,040 | 5 | % | 6 | % | ||||||||||
| Consumer Healthcare | 811 | 727 | 12 | % | 12 | % | ||||||||||
| Oncology | 372 | 288 | 29 | % | 31 | % | ||||||||||
| Other(5) | 53 | 53 | -- | -- | ||||||||||||
| Total | $ | 13,500 | $ | 14,885 | (9 | %) | (8 | %) | ||||||||
|
SELECTED ADJUSTED COSTS AND EXPENSES(2) |
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|
($ in millions)
(Favorable)/Unfavorable |
First-Quarter | ||||||||||||||
|
2013 |
2012 |
% Change | |||||||||||||
|
Total |
Operational | ||||||||||||||
| Cost of Sales(2) | $ | 2,615 | $ | 2,658 | (2 | %) | (2 | %) | |||||||
| As a Percent of Revenues | 19.4% | 17.9% | N/A | N/A | |||||||||||
| SI&A Expenses(2) | 3,494 | 3,948 | (11 | %) | (10 | %) | |||||||||
| R&D Expenses(2) | 1,708 | 1,756 | (3 | %) | (3 | %) | |||||||||
|
Total |
$ | 7,817 | $ | 8,362 | (7 | %) | (7 | %) | |||||||
| Effective Tax Rate(2) | 26.9% | 29.0% | N/A | N/A | |||||||||||
2013 FINANCIAL GUIDANCE(6)
Revenues and expenses of Zoetis(1) continue to be included
in the 2013 financial guidance, except that Adjusted(2)
and Reported(3) Diluted EPS guidance excludes the earnings
from the 19.8% divested interest effective February 7, 2013. The
financial guidance has been updated to reflect the following:
-
Reported Revenues: The changes in foreign exchange rates in relation
to the U.S. dollar from mid-January 2013 to mid-April 2013, notably
the weakening of the Japanese yen. -
Adjusted Diluted EPS(2): The aforementioned changes in
foreign exchange rates ($0.04 per share) as well as the impact of the
Zoetis(1) IPO ($0.02 per share) noted above. -
Reported Diluted EPS(3): The aforementioned changes in
foreign exchange rates and the impact of the Zoetis(1) IPO
as well as the gain associated with the transfer of certain product
rights to Pfizer’s joint venture with Zhejiang Hisun Pharmaceuticals
(Hisun) in China and an asset impairment charge.
| Reported Revenues |
$55.3 to $57.3 billion
(previously $56.2 to $58.2 billion) |
|
| Adjusted Cost of Sales(2) as a Percent of Revenues | 19.0% to 20.0% | |
| Adjusted SI&A Expenses(2) | $15.6 to $16.6 billion | |
| Adjusted R&D Expenses(2) | $6.5 to $7.0 billion | |
| Adjusted Other (Income)/Deductions(2) | Approximately $900 million | |
| Effective Tax Rate on Adjusted Income(2) | Approximately 28.0% | |
| Reported Diluted EPS(3) |
$1.44 to $1.59
(previously $1.50 to $1.65) |
|
| Adjusted Diluted EPS(2) |
$2.14 to $2.24
(previously $2.20 to $2.30) |
|
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, “As we begin
2013, we continue to generate attractive returns for our shareholders.
We are clearly seeing the benefits of the investments we’ve been making
in our innovative core, as evidenced by recent key product launches,
including Eliquis, Xeljanz and various oncology products, as well as
significant progress within our mid-to-late stage product pipeline, most
notably palbociclib. Additionally, I am very pleased with the successful
completion of the Zoetis(1) IPO and a related debt offering,
and with the value these actions have created thus far for Pfizer’s
shareholders. We remain focused on driving innovation and managing the
business in the context of the challenging operating environment to
ensure Pfizer remains well-positioned for long-term value creation, all
in the best interests of our shareholders.”
Frank D’Amelio, Chief Financial Officer, stated, “With our consistent
financial performance and strong cash flows, including the proceeds from
the sale of our Nutrition business in November last year and from the
IPO of a 19.8% interest in Zoetis(1) and a related debt
offering earlier this year, we continue to make prudent capital
allocation decisions for the benefit of our shareholders. So far this
year, we have returned approximately $8.0 billion to shareholders in
dividends and share repurchases, with significant additional capital
expected to be allocated to these activities for the remainder of the
year. Our solid performance during first-quarter 2013 was negatively
impacted by approximately $0.02 per share due to changes in foreign
exchange rates in relation to the U.S. dollar, including the devaluation
of the Venezuelan currency in February, since our initial financial
guidance was provided in January 2013.”
QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter
2013 vs. First-Quarter 2012)
-
Revenues decreased $1.4 billion, or 9%, which reflects an operational
decline of $1.3 billion, or 8%, and the unfavorable impact of foreign
exchange of $118 million, or 1%. The operational decrease was
primarily the result of the losses of exclusivity of Lipitor during
second-quarter 2012 in developed Europe and Geodon in March 2012 in
the U.S., the impact of purchasing patterns of Prevnar/Prevenar 13 in
various markets, and certain other events, primarily within the
Emerging Markets unit highlighted below. -
Business unit revenues were impacted by the following:
-
Primary Care: Revenues decreased 20% operationally, primarily due
to the shift in the reporting of Lipitor revenues in developed
Europe and Australia to the Established Products unit beginning
January 1, 2013, as well as the loss of exclusivity and near-term
expiration of co-promotion agreements for Aricept and Spiriva,
respectively, partially offset by the strong performance of Lyrica
in the U.S. and developed Europe. -
Specialty Care: Revenues declined 11% operationally, primarily due
to the timing of U.S. government purchases of Prevnar 13 and the
shift in the reporting of Geodon and Revatio revenues in the U.S.
and Xalabrands revenues in developed Europe and Australia to the
Established Products unit beginning January 1, 2013. -
Emerging Markets: Revenues grew 6% operationally, primarily due to
strong volume growth in China, which was partially offset by the
timing of government purchases of Enbrel and the Prevenar
franchise in certain emerging markets as well as the transfer of
certain product rights to the Pfizer-Hisun joint venture. -
Established Products: Revenues decreased 15% operationally,
primarily due to multi-source generic competition in the U.S. for
Lipitor beginning in late May 2012, as well as continuing
competitive and pricing pressures. This decrease was partially
offset by revenues from products in certain markets that were
shifted to the Established Products unit from other business units
beginning January 1, 2013. -
Consumer Healthcare: Revenues increased 12% operationally,
primarily due to the addition of Emergen-C from the acquisition of
Alacer Corp., as well as solid growth of key products, including
Advil and Robitussin, partially due to a severe cold and flu
season in the U.S. -
Oncology: Revenues increased 31% operationally, driven by the
recent launches of new products, most notably Inlyta and Xalkori
in several major markets.
-
Primary Care: Revenues decreased 20% operationally, primarily due
-
Adjusted cost of sales, adjusted SI&A expenses and adjusted R&D
expenses(2) in the aggregate decreased $545 million, or 7%,
primarily reflecting the benefits of cost-reduction and productivity
initiatives, including a reduction in the field force and more
streamlined corporate support functions and manufacturing network. -
The effective tax rate on adjusted income(2) decreased 2.1
percentage points, primarily due to the change in the jurisdictional
mix of earnings and the extension of the U.S. research and development
tax credit that was signed into law in January 2013. The first-quarter
2013 rate reflects the full-year benefit of the 2012 research and
development tax credit and a portion of the 2013 research and
development tax credit. -
The diluted weighted-average shares outstanding declined by
approximately 329 million shares, primarily due to the Company’s
ongoing share-repurchase program. -
In addition to the aforementioned factors, first-quarter 2013 reported
earnings were favorably impacted by lower charges related to legal
matters, lower costs related to cost-reduction and productivity
initiatives, and lower purchase accounting adjustments. Additionally,
reported earnings were favorably impacted by the gain associated with
the transfer of certain product rights to the Pfizer-Hisun joint
venture, partially offset by less income from discontinued operations
reflecting the divestiture of the Nutrition business in November 2012.
RECENT NOTABLE DEVELOPMENTS
Product Developments
-
Eliquis was launched in the U.S., UK, Germany, Denmark and Japan for
the reduction in the risk of stroke and systemic embolism in patients
with nonvalvular atrial fibrillation. -
The Xeljanz U.S. field force launch meeting was held in early March.
Additionally, Xeljanz was approved in Japan for the treatment of
adults with rheumatoid arthritis (RA) who have had an inadequate
response to existing therapies, such as methotrexate. -
Bosulif was granted conditional marketing authorization by the
European Commission for use in certain patients with previously
treated chronic myelogenous leukemia. -
Quillivant XR, the first once-daily, extended-release, liquid
methylphenidate for attention deficit hyperactivity disorder, was
launched in the U.S. -
The U.S. Patent and Trademark Office granted Pfizer a reissue patent
covering Celebrex. The reissue patent will expire in December 2015,
while the basic patent will expire in May 2014, in each case including
six months of pediatric exclusivity. Pfizer has initiated legal
proceedings against several generic companies to enforce the reissued
patent.
Pipeline Developments
-
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency adopted a negative opinion for Xeljanz for
the treatment of adult patients with moderate-to-severe active RA. The
CHMP is of the opinion that Xeljanz does not demonstrate a favorable
benefit:risk profile. Pfizer intends to appeal this opinion and
immediately seek a re-examination of the opinion by the CHMP. -
Palbociclib received Breakthrough Therapy designation by the U.S. Food
and Drug Administration (FDA) for the potential treatment of patients
with breast cancer. Additionally, a randomized phase 3 study
evaluating palbociclib in combination with letrozole for first-line
treatment of post-menopausal women with ER+/HER2- advanced breast
cancer began enrolling patients in February. -
Inotuzumab ozogamicin received Orphan Drug designation from the FDA
for the treatment of acute lymphoblastic leukemia.
Business Development/Portfolio Review
-
An IPO of a 19.8% ownership interest in Zoetis(1) as well
as a related debt offering were completed. Total proceeds of
approximately $6 billion from these transactions are being allocated
to share repurchases, which remain the case to beat for capital
allocation. -
Pfizer entered into a worldwide (except Japan) collaboration agreement
with Merck & Co., Inc. to develop and commercialize ertugliflozin and
ertugliflozin-containing fixed-dose combinations with metformin and
Januvia® (sitagliptin) tablets. Ertugliflozin is
Pfizer’s investigational medicine for type 2 diabetes, with phase 3
trials expected to begin later in 2013.
For additional details, see the attached financial schedules, product
revenue tables and disclosure notice.
| (1) |
An initial public offering (IPO) of a 19.8% ownership interest in |
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Pfizer continues to consolidate Zoetis, as Pfizer retains an 80.2% |
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| (2) |
"Adjusted Income" and its components and "Adjusted Diluted |
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| (3) |
“Reported Net Income” is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. “Reported Diluted EPS” is defined as reported diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. |
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| (4) |
For a description of the revenues in each business unit, see Note 18A to Pfizer’s consolidated financial statements included in Pfizer’s Form 10-K/A for the year ended December 31, 2012. Revenues for certain products in certain markets that were reported in the Primary Care and Specialty Care units through December 31, 2012 are being reported in the Established Products unit beginning January 1, 2013, as follows: |
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(5) |
Other represents revenues generated from Pfizer CentreSource, |
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(6) |
The 2013 financial guidance reflects the following: |
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| ($ in billions, except per share amounts) | |||||
| Income/(Expense) | Net Income | Diluted EPS | |||
| Adjusted income/diluted EPS(2) guidance |
$15.0 - $15.7 |
$2.14 - $2.24 | |||
|
Purchase accounting impacts of transactions completed as of |
(3.4) | (0.49) | |||
| Acquisition-related costs | (0.4 - 0.5) | (0.06 - 0.07) | |||
|
Certain other items, including non-acquisition-related restructuring costs |
(0.5 - 0.8) |
(0.08 - 0.12) | |||
| Costs associated with the separation of Zoetis(1) | (0.2) | (0.02) | |||
|
Reported net income attributable to Pfizer Inc./diluted EPS(3) guidance |
$10.1 - $11.2 |
$1.44 - $1.59 | |||
| PFIZER INC. AND SUBSIDIARY COMPANIES | |||||||||
| CONSOLIDATED STATEMENTS OF INCOME(1) | |||||||||
| (UNAUDITED) | |||||||||
| (millions, except per common share data) | |||||||||
| First-Quarter |
% Incr. / |
||||||||
| 2013 | 2012 | (Decr.) | |||||||
| Revenues | $ | 13,500 | $ | 14,885 | (9 | ) | |||
| Costs and expenses: | |||||||||
| Cost of sales(2) | 2,652 | 2,745 | (3 | ) | |||||
| Selling, informational and administrative expenses(2) | 3,585 | 3,968 | (10 | ) | |||||
| Research and development expenses(2) | 1,800 | 2,062 | (13 | ) | |||||
| Amortization of intangible assets(3) | 1,234 | 1,420 | (13 | ) | |||||
| Restructuring charges and certain acquisition-related costs | 138 | 597 | (77 | ) | |||||
| Other deductions––net(4) | 170 | 1,658 | (90 | ) | |||||
|
Income from continuing operations before provision for taxes on |
3,921 | 2,435 | 61 | ||||||
| Provision for taxes on income | 1,160 | 711 | 63 | ||||||
| Income from continuing operations | 2,761 | 1,724 | 60 | ||||||
| Discontinued operations––net of tax | 4 | 79 | (95 | ) | |||||
| Net income before allocation to noncontrolling interests | 2,765 | 1,803 | 53 | ||||||
| Less: Net income attributable to noncontrolling interests | 15 | 9 | 67 | ||||||
| Net income attributable to Pfizer Inc. | $ | 2,750 | $ | 1,794 | 53 | ||||
| Earnings per common share––basic: | |||||||||
|
Income from continuing operations attributable to Pfizer Inc. |
$ | 0.38 | $ | 0.23 | 65 | ||||
| Discontinued operations––net of tax | - | 0.01 | (100 | ) | |||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 0.38 | $ | 0.24 | 58 | ||||
| Earnings per common share––diluted: | |||||||||
|
Income from continuing operations attributable to Pfizer Inc. |
$ | 0.38 | $ | 0.23 | 65 | ||||
| Discontinued operations––net of tax | - | 0.01 | (100 | ) | |||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 0.38 | $ | 0.24 | 58 | ||||
| Weighted-average shares used to calculate earnings per common share: | |||||||||
| Basic | 7,187 | 7,537 | |||||||
| Diluted | 7,269 | 7,598 | |||||||
| See next page for notes (1) through (4) | |||||||||
| PFIZER INC. AND SUBSIDIARY COMPANIES | |||||||||||||
| NOTES TO CONSOLIDATED STATEMENTS OF INCOME | |||||||||||||
| (UNAUDITED) | |||||||||||||
| (1) |
These financial statements present the three months ended March |
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On November 30, 2012, we completed the sale of our Nutrition business. The operating results of this business are reported as Discontinued operations––net of tax for the three months ended April 1, 2012. |
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The financial results for the three months ended March 31, 2013 are not necessarily indicative of the results which could ultimately be achieved for the full year. |
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| (2) |
Exclusive of amortization of intangible assets, except as discussed in footnote (3) below. |
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| (3) |
Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses or Research and development expenses, as appropriate. |
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| (4) | Other deductions––net includes the following: | ||||||||||||
| First-Quarter | |||||||||||||
| (millions of dollars) | 2013 | 2012 | |||||||||||
| Interest income(a) | $ | (95 | ) | $ | (81 | ) | |||||||
| Interest expense(a) | 391 | 390 | |||||||||||
| Net interest expense | 296 | 309 | |||||||||||
| Royalty-related income | (71 | ) | (97 | ) | |||||||||
| Gain associated with Pfizer's joint venture in China(b) | (490 | ) | - | ||||||||||
| Net gain on asset disposals | (26 | ) | (7 | ) | |||||||||
| Certain legal matters, net(c) | (83 | ) | 814 | ||||||||||
| Certain asset impairment charges(d) | 399 | 432 | |||||||||||
| Costs associated with the separation of Zoetis(e) | 17 | 32 | |||||||||||
| Other, net | 128 | 175 | |||||||||||
| Other deductions––net | $ | 170 | $ | 1,658 | |||||||||
| (a) |
Interest income increased in first-quarter 2013 due to higher cash balances. Interest expense was virtually unchanged in first-quarter 2013 compared to first-quarter 2012 as the impact of the Zoetis debt issuance on January 28, 2013 was offset by otherwise lower debt balances. |
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| (b) |
Represents the gain associated with the transfer of certain product rights to Pfizer's 49%-owned equity-method investment in China. |
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| (c) |
In first-quarter 2013, primarily includes an $80 million insurance recovery related to a certain litigation matter. In first-quarter 2012, primarily relates to a $450 million settlement of a lawsuit by Brigham Young University related to Celebrex and charges related to hormone-replacement therapy litigation. |
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| (d) |
In first-quarter 2013, significantly relates to developed |
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| (e) |
Costs incurred in connection with the initial public offering of an approximate 19.8% ownership interest in Zoetis. Includes expenditures for banking, legal, accounting and similar services. |
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| PFIZER INC. AND SUBSIDIARY COMPANIES | |||||||||||||||||||||
| RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||||||||||
| CERTAIN LINE ITEMS | |||||||||||||||||||||
| (UNAUDITED) | |||||||||||||||||||||
| (millions of dollars, except per common share data) | |||||||||||||||||||||
| Three Months Ended March 31, 2013 | |||||||||||||||||||||
| Purchase | Acquisition- | Certain | |||||||||||||||||||
| GAAP | Accounting | Related | Discontinued | Significant | Non-GAAP | ||||||||||||||||
| Reported(1) | Adjustments | Costs(2) | Operations | Items(3) | Adjusted(4) | ||||||||||||||||
| Revenues | $ | 13,500 | $ | - | $ | - | $ | - | $ | - | $ | 13,500 | |||||||||
| Cost of sales(5) | 2,652 | 5 | (33 | ) | - | (9 | ) | 2,615 | |||||||||||||
| Selling, informational and administrative expenses(5) | 3,585 | 7 | (2 | ) | - | (96 | ) | 3,494 | |||||||||||||
| Research and development expenses(5) | 1,800 | 1 | - | - | (93 | ) | 1,708 | ||||||||||||||
| Amortization of intangible assets(6) | 1,234 | (1,191 | ) | - | - | - | 43 | ||||||||||||||
| Restructuring charges and certain acquisition-related costs | 138 | - | (60 | ) | - | (78 | ) | - | |||||||||||||
| Other deductions––net | 170 | (54 | ) | - | - | 148 | 264 | ||||||||||||||
|
Income from continuing operations before provision for taxes on income |
3,921 | 1,232 | 95 | - | 128 | 5,376 | |||||||||||||||
| Provision for taxes on income | 1,160 | 339 | 27 | - | (80 | ) | 1,446 | ||||||||||||||
| Income from continuing operations | 2,761 | 893 | 68 | - | 208 | 3,930 | |||||||||||||||
| Discontinued operations––net of tax | 4 | - | - | (4 | ) | - | - | ||||||||||||||
| Net income attributable to noncontrolling interests | 15 | 1 | - | - | 3 | 19 | |||||||||||||||
| Net income attributable to Pfizer Inc. | 2,750 | 892 | 68 | (4 | ) | 205 | 3,911 | ||||||||||||||
| Earnings per common share attributable to Pfizer Inc.––diluted | 0.38 | 0.12 | 0.01 | - | 0.03 | 0.54 | |||||||||||||||
| Three Months Ended April 1, 2012 | |||||||||||||||||||||
| Purchase | Acquisition- | Certain | |||||||||||||||||||
| GAAP | Accounting | Related | Discontinued | Significant | Non-GAAP | ||||||||||||||||
| Reported(1) | Adjustments | Costs(2) | Operations | Items(3) | Adjusted(4) | ||||||||||||||||
| Revenues | $ | 14,885 | $ | - | $ | - | $ | - | $ | - | $ | 14,885 | |||||||||
| Cost of sales(5) | 2,745 | (8 | ) | (79 | ) | - | - | 2,658 | |||||||||||||
| Selling, informational and administrative expenses(5) | 3,968 | 3 | (1 | ) | - | (22 | ) | 3,948 | |||||||||||||
| Research and development expenses(5) | 2,062 | 1 | (5 | ) | - | (302 | ) | 1,756 | |||||||||||||
| Amortization of intangible assets(6) | 1,420 | (1,352 | ) | - | - | - | 68 | ||||||||||||||
| Restructuring charges and certain acquisition-related costs | 597 | - | (98 | ) | - | (499 | ) | - | |||||||||||||
| Other deductions––net | 1,658 | (90 | ) | - | - | (1,244 | ) | 324 | |||||||||||||
|
Income from continuing operations before provision for taxes on income |
2,435 | 1,446 | 183 | - | 2,067 | 6,131 | |||||||||||||||
| Provision for taxes on income | 711 | 384 | 67 | - | 616 | 1,778 | |||||||||||||||
| Income from continuing operations | 1,724 | 1,062 | 116 | - | 1,451 | 4,353 | |||||||||||||||
| Discontinued operations––net of tax | 79 | - | - | (79 | ) | - | - | ||||||||||||||
| Net income attributable to noncontrolling interests | 9 | - | - | - | - | 9 | |||||||||||||||
| Net income attributable to Pfizer Inc. | 1,794 | 1,062 | 116 | (79 | ) | 1,451 | 4,344 | ||||||||||||||
| Earnings per common share attributable to Pfizer Inc.––diluted | 0.24 | 0.14 | 0.02 | (0.01 | ) | 0.19 | 0.57 | ||||||||||||||
| See end of tables for notes (1) through (6). | |||||||||||||||||||||
| Certain amounts may reflect rounding adjustments. | |||||||||||||||||||||
| EPS amounts may not add due to rounding. | |||||||||||||||||||||
| PFIZER INC. AND SUBSIDIARY COMPANIES | |||||||||||||
|
NOTES TO RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
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| CERTAIN LINE ITEMS | |||||||||||||
| (UNAUDITED) | |||||||||||||
| (1) |
These financial statements present the three months ended March 31, 2013 and April 1, 2012. Subsidiaries operating outside the United States are included for the three months ended February 24, 2013 and February 26, 2012. |
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|
On November 30, 2012, we completed the sale of our Nutrition business. The operating results of this business are reported as Discontinued operations––net of tax for the three months ended April 1, 2012. |
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| (2) | Acquisition-related costs include the following: | ||||||||||||
| First-Quarter | |||||||||||||
| (millions of dollars) | 2013 | 2012 | |||||||||||
| Integration costs(a) | $ | 39 | $ | 100 | |||||||||
| Restructuring charges(a) | 21 | (2 | ) | ||||||||||
| Additional depreciation––asset restructuring(b) | 35 | 85 | |||||||||||
| Total acquisition-related costs––pre-tax | 95 | 183 | |||||||||||
| Income taxes(c) | (27 | ) | (67 | ) | |||||||||
| Total acquisition-related costs––net of tax | $ | 68 | $ | 116 | |||||||||
| (a) |
Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. Restructuring charges include employee termination costs, asset impairments and other exit costs associated with business combinations. All of these costs and charges are included in Restructuring charges and certain acquisition-related costs. |
||||||||||||
| (b) |
Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions related to acquisitions. Included in Cost of sales ($33 million) and Selling, informational and administrative expenses ($2 million) for the three months ended March 31, 2013. Included in Cost of sales ($79 million), Research and development expenses ($5 million) and Selling, informational and administrative expenses ($1 million) for the three months ended April 1, 2012. |
||||||||||||
| (c) | Included in Provision for taxes on income. | ||||||||||||
| (3) | Certain significant items include the following: | ||||||||||||
| First-Quarter | |||||||||||||
| (millions of dollars) | 2013 | 2012 | |||||||||||
| Restructuring charges(a) | $ | 78 | $ | 499 | |||||||||
|
Implementation costs and additional depreciation––asset |
139 | 318 | |||||||||||
| Certain legal matters(c) | (87 | ) | 775 | ||||||||||
| Certain asset impairment charges(d) | 396 | 412 | |||||||||||
| Gain associated with Pfizer's joint venture in China(e) | (490 | ) | - | ||||||||||
| Costs associated with the separation of Zoetis(f) | 76 | 38 | |||||||||||
| Other | 16 | 25 | |||||||||||
|
Certain significant items––pre-tax |
128 | 2,067 | |||||||||||
| Income taxes(g) | 80 | (616 | ) | ||||||||||
|
Certain significant items––net of tax |
$ | 208 | $ | 1,451 | |||||||||
| (a) |
Primarily relates to our cost-reduction and productivity initiatives. Included in Restructuring charges and certain acquisition-related costs. |
||||||||||||
| (b) |
Primarily relates to our cost-reduction and productivity initiatives. Included in Research and development expenses ($93 million), Selling, informational and administrative expenses ($40 million) and Cost of sales ($6 million) for the three months ended March 31, 2013. Included in Research and development expenses ($302 million) and Selling, informational and administrative expenses ($16 million) for the three months ended April 1, 2012. |
||||||||||||
| (c) |
Included in Other deductions––net. In 2013, primarily includes an $80 million insurance recovery related to a certain litigation matter. In 2012, primarily relates to a $450 million settlement of a lawsuit by Brigham Young University related to Celebrex and charges related to hormone-replacement therapy litigation. |
||||||||||||
| (d) |
Included in Other deductions––net. In 2013, significantly |
||||||||||||
| (e) |
Included in Other deductions––net. Represents the gain associated with the transfer of certain product rights to Pfizer's 49%-owned equity-method investment in China. |
||||||||||||
| (f) |
Costs incurred in connection with the initial public offering of an approximate 19.8% ownership interest in Zoetis. Includes expenditures for banking, legal, accounting and similar services, as well as costs associated with the separation of Zoetis employees, net assets and operations from Pfizer, such as consulting and systems costs. Included in Selling, informational and administrative expenses ($56 million), Other deductions––net ($17 million) and Cost of Sales ($3 million) for the three months ended March 31, 2013. Included in Other deductions––net ($32 million) and Selling, informational and administrative expenses ($6 million) for the three months ended April 1, 2012. |
||||||||||||
| (g) | Included in Provision for taxes on income. | ||||||||||||
| (4) |
Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS. Despite the importance of these measures to management in goal setting and performance measurement, Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are Non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS (unlike U.S. GAAP net income and its components and diluted EPS) may not be comparable to the calculation of similar measures of other companies. Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are presented solely to permit investors to more fully understand how management assesses performance. |
||||||||||||
| (5) |
Exclusive of amortization of intangible assets, except as discussed in footnote (6) below. |
||||||||||||
| (6) |
Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses or Research and development expenses, as appropriate. |
||||||||||||
| PFIZER INC. | |||||||||||||||||||||||||||||||||
| REVENUES | |||||||||||||||||||||||||||||||||
|
FIRST-QUARTER 2013 and 2012 |
|||||||||||||||||||||||||||||||||
| (UNAUDITED) | |||||||||||||||||||||||||||||||||
| (millions of dollars) | |||||||||||||||||||||||||||||||||
| WORLDWIDE | UNITED STATES | TOTAL INTERNATIONAL(a) | |||||||||||||||||||||||||||||||
|
|
|
% Change |
|
|
% Change |
|
|
% Change | |||||||||||||||||||||||||
|
2013 |
2012 |
Total | Oper. |
2013 |
2012 |
Total |
2013 |
2012 |
Total | Oper. | |||||||||||||||||||||||
| TOTAL REVENUES | $ | 13,500 | $ | 14,885 | (9 | %) | (8 | %) | $ |
5,368 |
$ | 5,952 | (10 | %) | $ |
8,132 |
$ | 8,933 | (9 | %) | (8 | %) | |||||||||||
| REVENUES FROM BIOPHARMACEUTICAL PRODUCTS: | $ | 11,546 | $ | 13,065 | (12 | %) | (11 | %) | $ | 4,517 | $ | 5,185 | (13 | %) | $ | 7,029 | $ | 7,880 | (11 | %) | (9 | %) | |||||||||||
| Lyrica | 1,066 | 955 | 12 | % | 12 | % | 438 | 395 | 11 | % | 628 | 560 | 12 | % | 14 | % | |||||||||||||||||
| Enbrel (Outside the U.S. and Canada) | 877 | 899 | (2 | %) | (1 | %) | - | - | - | 877 | 899 | (2 | %) | (1 | %) | ||||||||||||||||||
| Prevnar 13/Prevenar 13 | 846 | 945 | (10 | %) | (11 | %) | 450 | 556 | (19 | %) | 396 | 389 | 2 | % | 1 | % | |||||||||||||||||
| Celebrex | 653 | 634 | 3 | % | 4 | % | 424 | 407 | 4 | % | 229 | 227 | 1 | % | 3 | % | |||||||||||||||||
| Lipitor(b) | 626 | 1,395 | (55 | %) | (55 | %) | 171 | 383 | (55 | %) | 455 | 1,012 | (55 | %) | (54 | %) | |||||||||||||||||
| Viagra | 461 | 496 | (7 | %) | (7 | %) | 245 | 268 | (9 | %) | 216 | 228 | (5 | %) | (6 | %) | |||||||||||||||||
| Zyvox | 342 | 325 | 5 | % | 6 | % | 176 | 171 | 3 | % | 166 | 154 | 8 | % | 10 | % | |||||||||||||||||
| Sutent | 302 | 300 | 1 | % | 1 | % | 84 | 86 | (2 | %) | 218 | 214 | 2 | % | 3 | % | |||||||||||||||||
| Norvasc | 301 | 334 | (10 | %) | (6 | %) | 10 | 14 | (29 | %) | 291 | 320 | (9 | %) | (5 | %) | |||||||||||||||||
| Premarin family | 244 | 261 | (7 | %) | (6 | %) | 220 | 237 | (7 | %) | 24 | 24 | - | 1 | % | ||||||||||||||||||
| Genotropin | 189 | 195 | (3 | %) | (1 | %) | 47 | 41 | 15 | % | 142 | 154 | (8 | %) | (5 | %) | |||||||||||||||||
| BeneFIX | 189 | 183 | 3 | % | 3 | % | 88 | 85 | 4 | % | 101 | 98 | 3 | % | 2 | % | |||||||||||||||||
| Vfend | 187 | 178 | 5 | % | 7 | % | 17 | 25 | (32 | %) | 170 | 153 | 11 | % | 13 | % | |||||||||||||||||
| Chantix/Champix | 166 | 178 | (7 | %) | (6 | %) | 87 | 92 | (5 | %) | 79 | 86 | (8 | %) | (5 | %) | |||||||||||||||||
| Pristiq | 166 | 151 | 10 | % | 10 | % | 131 | 121 | 8 | % | 35 | 30 | 17 | % | 19 | % | |||||||||||||||||
| Detrol/Detrol LA | 151 | 195 | (23 | %) | (22 | %) | 103 | 123 | (16 | %) | 48 | 72 | (33 | %) | (32 | %) | |||||||||||||||||
| Xalatan/Xalacom | 147 | 227 | (35 | %) | (33 | %) | 8 | 11 | (27 | %) | 139 | 216 | (36 | %) | (33 | %) | |||||||||||||||||
| Refacto AF/Xyntha | 139 | 132 | 5 | % | 5 | % | 29 | 25 | 16 | % | 110 | 107 | 3 | % | 2 | % | |||||||||||||||||
| Zithromax/Zmax | 116 | 123 | (6 | %) | (2 | %) | 4 | 5 | (20 | %) | 112 | 118 | (5 | %) | (2 | %) | |||||||||||||||||
| Zoloft | 116 | 130 | (11 | %) | (6 | %) | 14 | 17 | (18 | %) | 102 | 113 | (10 | %) | (4 | %) | |||||||||||||||||
| Medrol | 113 | 134 | (16 | %) | (16 | %) | 40 | 38 | 5 | % | 73 | 96 | (24 | %) | (24 | %) | |||||||||||||||||
| Effexor | 105 | 129 | (19 | %) | (19 | %) | 36 | 41 | (12 | %) | 69 | 88 | (22 | %) | (22 | %) | |||||||||||||||||
| Zosyn/Tazocin | 87 | 128 | (32 | %) | (32 | %) | 36 | 64 | (44 | %) | 51 | 64 | (20 | %) | (20 | %) | |||||||||||||||||
| Tygacil | 87 | 81 | 7 | % | 7 | % | 43 | 40 | 8 | % | 44 | 41 | 7 | % | 7 | % | |||||||||||||||||
| Relpax | 86 | 85 | 1 | % | 2 | % | 52 | 51 | 2 | % | 34 | 34 | - | 2 | % | ||||||||||||||||||
| Fragmin | 86 | 91 | (5 | %) | (8 | %) | 10 | 12 | (17 | %) | 76 | 79 | (4 | %) | (6 | %) | |||||||||||||||||
| Rapamune | 84 | 82 | 2 | % | 3 | % | 49 | 45 | 9 | % | 35 | 37 | (5 | %) | (5 | %) | |||||||||||||||||
| Prevnar/Prevenar (7-valent) | 81 | 138 | (41 | %) | (33 | %) | - | - | - | 81 | 138 | (41 | %) | (33 | %) | ||||||||||||||||||
| Cardura | 76 | 84 | (10 | %) | (6 | %) | 1 | 1 | - | 75 | 83 | (10 | %) | (6 | %) | ||||||||||||||||||
| EpiPen | 72 | 58 | 24 | % | 24 | % | 62 | 51 | 22 | % | 10 | 7 | 43 | % | 43 | % | |||||||||||||||||
| Revatio | 72 | 136 | (47 | %) | (46 | %) | 14 | 85 | (84 | %) | 58 | 51 | 14 | % | 14 | % | |||||||||||||||||
| Sulperazon | 71 | 58 | 22 | % | 23 | % | - | - | - | 71 | 58 | 22 | % | 23 | % | ||||||||||||||||||
| Xanax XR | 70 | 68 | 3 | % | 3 | % | 12 | 14 | (14 | %) | 58 | 54 | 7 | % | 8 | % | |||||||||||||||||
| Inlyta | 63 | 7 | * | * | 35 | 7 | * | 28 | - | * | * | ||||||||||||||||||||||
| Aricept(c) | 62 | 94 | (34 | %) | (35 | %) | - | - | - | 62 | 94 | (34 | %) | (35 | %) | ||||||||||||||||||
| Unasyn | 56 | 54 | 4 | % | 7 | % | 1 | - | * | 55 | 54 | 2 | % | 6 | % | ||||||||||||||||||
| Caduet | 56 | 65 | (14 | %) | (12 | %) | 5 | 9 | (44 | %) | 51 | 56 | (9 | %) | (8 | %) | |||||||||||||||||
| Xalkori | 53 | 17 | 212 | % | * | 28 | 14 | 100 | % | 25 | 3 | * | * | ||||||||||||||||||||
| Neurontin | 52 | 58 | (10 | %) | (11 | %) | 10 | 13 | (23 | %) | 42 | 45 | (7 | %) | (7 | %) | |||||||||||||||||
| Inspra | 52 | 49 | 6 | % | 9 | % | 1 | 1 | - | 51 | 48 | 6 | % | 9 | % | ||||||||||||||||||
| Toviaz | 52 | 46 | 13 | % | 11 | % | 27 | 25 | 8 | % | 25 | 21 | 19 | % | 19 | % | |||||||||||||||||
| Aromasin | 51 | 56 | (9 | %) | (8 | %) | 3 | 4 | (25 | %) | 48 | 52 | (8 | %) | (8 | %) | |||||||||||||||||
| Dalacin/Cleocin | 50 | 49 | 2 | % | 2 | % | 17 | 15 | 13 | % | 33 | 34 | (3 | %) | (3 | %) | |||||||||||||||||
| Alliance revenues(d) | 747 | 836 | (11 | %) | (10 | %) | 635 | 580 | 9 | % | 112 | 256 | (56 | %) | (55 | %) | |||||||||||||||||
| All other biopharmaceutical products(e) | 1,878 | 2,226 | (16 | %) | (15 | %) | 654 | 1,013 | (35 | %) | 1,224 | 1,213 | 1 | % | 3 | % | |||||||||||||||||
| All other established products(e) | 1,428 | 1,563 | (9 | %) | (8 | %) | 475 | 634 | (25 | %) | 953 | 929 | 3 | % | 4 | % | |||||||||||||||||
| REVENUES FROM OTHER PRODUCTS: | |||||||||||||||||||||||||||||||||
| ZOETIS | $ | 1,090 | $ | 1,040 | 5 | % | 6 | % | $ |
454 |
$ | 422 |
8 |
% | $ |
636 |
$ | 618 |
3 |
% |
4 |
% | |||||||||||
| CONSUMER HEALTHCARE | $ | 811 | $ | 727 | 12 | % | 12 | % | $ | 378 | $ | 326 | 16 | % | $ | 433 | $ | 401 | 8 | % | 7 | % | |||||||||||
| OTHER(f) | $ | 53 | $ | 53 | - | - | $ | 19 | $ | 19 | - | $ | 34 | $ | 34 | - | - | ||||||||||||||||
|
* Calculation not meaningful. |
||
| (a) |
Total International represents Developed Europe region + Developed Rest of World region + Emerging Markets region. Details for these regions are located on the following page. |
|
| (b) |
Lipitor lost exclusivity in the U.S. in November 2011 and various other major markets in 2011 and 2012. This loss of exclusivity reduced branded worldwide revenues by $792 million in first-quarter 2013, in comparison with first-quarter 2012. |
|
| (c) | Represents direct sales under license agreement with Eisai Co., Ltd. | |
| (d) |
Includes Enbrel (in the U.S. and Canada), Spiriva, Rebif, Aricept and Eliquis. |
|
| (e) |
Includes sales of generic atorvastatin. All other established products is a subset of All other biopharmaceutical products. |
|
| (f) |
Represents revenues generated from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization. |
|
| Certain amounts and percentages may reflect rounding adjustments. | ||
| PFIZER INC. | ||||||||||||||||||||||||||||||||||||
| INTERNATIONAL REVENUES BY GEOGRAPHIC REGION | ||||||||||||||||||||||||||||||||||||
| FIRST-QUARTER 2013 and 2012 | ||||||||||||||||||||||||||||||||||||
| (UNAUDITED) | ||||||||||||||||||||||||||||||||||||
| (millions of dollars) | ||||||||||||||||||||||||||||||||||||
| DEVELOPED EUROPE(a) | DEVELOPED REST OF WORLD(b) | EMERGING MARKETS(c) | ||||||||||||||||||||||||||||||||||
|
|
|
% Change |
|
|
% Change |
|
|
% Change | ||||||||||||||||||||||||||||
|
2013 |
2012 |
Total | Oper. |
2013 |
2012 |
Total | Oper. |
2013 |
2012 |
Total | Oper. | |||||||||||||||||||||||||
| TOTAL INTERNATIONAL REVENUES | $ |
3,029 |
$ | 3,537 |
(14 |
%) |
(15 |
%) | $ | 2,172 | $ | 2,612 | (17 | %) | (12 | %) | $ | 2,931 | $ | 2,784 | 5 | % | 6 | % | ||||||||||||
| REVENUES FROM BIOPHARMACEUTICAL PRODUCTS - INTERNATIONAL: | $ | 2,668 | $ | 3,207 | (17 | %) | (18 | %) | $ | 1,941 | $ | 2,374 | (18 | %) | (12 | %) | $ | 2,420 | $ | 2,299 | 5 | % | 6 | % | ||||||||||||
| Lyrica | 340 | 300 | 13 | % | 12 | % | 171 | 169 | 1 | % | 10 | % | 117 | 91 | 29 | % | 29 | % | ||||||||||||||||||
| Enbrel (Outside Canada) | 556 | 550 | 1 | % | (1 | %) | 124 | 155 | (20 | %) | (13 | %) | 197 | 194 | 2 | % | 6 | % | ||||||||||||||||||
| Prevnar 13/Prevenar 13 | 167 | 160 | 4 | % | 3 | % | 63 | 75 | (16 | %) | (20 | %) | 166 | 154 | 8 | % | 10 | % | ||||||||||||||||||
| Celebrex | 38 | 41 | (7 | %) | (10 | %) | 107 | 107 | - | 6 | % | 84 | 79 | 6 | % | 5 | % | |||||||||||||||||||
| Lipitor(d) | 73 | 519 | (86 | %) | (86 | %) | 129 | 282 | (54 | %) | (51 | %) | 253 | 211 | 20 | % | 19 | % | ||||||||||||||||||
| Viagra | 93 | 87 | 7 | % | 6 | % | 40 | 51 | (22 | %) | (21 | %) | 83 | 90 | (8 | %) | (8 | %) | ||||||||||||||||||
| Zyvox | 75 | 72 | 4 | % | 3 | % | 33 | 37 | (11 | %) | - | 58 | 45 | 29 | % | 31 | % | |||||||||||||||||||
| Sutent | 101 | 105 | (4 | %) | (6 | %) | 33 | 39 | (15 | %) | (13 | %) | 84 | 70 | 20 | % | 23 | % | ||||||||||||||||||
| Norvasc | 27 | 32 | (16 | %) | (19 | %) | 124 | 164 | (24 | %) | (16 | %) | 140 | 124 | 13 | % | 12 | % | ||||||||||||||||||
| Premarin family | 2 | 2 | - | - | 9 | 8 | 13 | % | - | 13 | 14 | (7 | %) | (7 | %) | |||||||||||||||||||||
| Genotropin | 65 | 76 | (14 | %) | (16 | %) | 50 | 52 | (4 | %) | 4 | % | 27 | 26 | 4 | % | 4 | % | ||||||||||||||||||
| BeneFIX | 57 | 57 | - | (2 | %) | 34 | 32 | 6 | % | 3 | % | 10 | 9 | 11 | % | 11 | % | |||||||||||||||||||
| Vfend | 71 | 67 | 6 | % | 4 | % | 37 | 37 | - | 8 | % | 62 | 49 | 27 | % | 27 | % | |||||||||||||||||||
| Chantix/Champix | 32 | 34 | (6 | %) | (6 | %) | 35 | 41 | (15 | %) | (12 | %) | 12 | 11 | 9 | % | 19 | % | ||||||||||||||||||
| Pristiq | - | - | - | - | 23 | 19 | 21 | % | 21 | % | 12 | 11 | 9 | % | 9 | % | ||||||||||||||||||||
| Detrol/Detrol LA | 15 | 34 | (56 | %) | (59 | %) | 22 | 24 | (8 | %) | (4 | %) | 11 | 14 | (21 | %) | (21 | %) | ||||||||||||||||||
| Xalatan/Xalacom | 39 | 93 | (58 | %) | (59 | %) | 58 | 79 | (27 | %) | (20 | %) | 42 | 44 | (5 | %) | - | |||||||||||||||||||
| Refacto AF/Xyntha | 89 | 87 | 2 | % | 1 | % | 18 | 11 | 64 | % | 64 | % | 3 | 9 | (67 | %) | (67 | %) | ||||||||||||||||||
| Zithromax/Zmax | 18 | 17 | 6 | % | 6 | % | 40 | 53 | (25 | %) | (17 | %) | 54 | 48 | 13 | % | 13 | % | ||||||||||||||||||
| Zoloft | 15 | 15 | - | (7 | %) | 55 | 66 | (17 | %) | (6 | %) | 32 | 32 | - | - | |||||||||||||||||||||
| Medrol | 22 | 24 | (8 | %) | (8 | %) | 10 | 11 | (9 | %) | (9 | %) | 41 | 61 | (33 | %) | (34 | %) | ||||||||||||||||||
| Effexor | 24 | 30 | (20 | %) | (23 | %) | 18 | 34 | (47 | %) | (50 | %) | 27 | 24 | 13 | % | 13 | % | ||||||||||||||||||
| Zosyn/Tazocin | 11 | 13 | (15 | %) | (15 | %) | 3 | 4 | (25 | %) | (25 | %) | 37 | 47 | (21 | %) | (21 | %) | ||||||||||||||||||
| Tygacil | 16 | 15 | 7 | % | 7 | % | 2 | 1 | 100 | % | 100 | % | 26 | 25 | 4 | % | 4 | % | ||||||||||||||||||
| Relpax | 17 | 17 | - | - | 12 | 13 | (8 | %) | 8 | % | 5 | 4 | 25 | % | 25 | % | ||||||||||||||||||||
| Fragmin | 42 | 43 | (2 | %) | (5 | %) | 18 | 18 | - | - | 16 | 18 | (11 | %) | (11 | %) | ||||||||||||||||||||
| Rapamune | 12 | 12 | - | - | 4 | 4 | - | - | 19 | 21 | (10 | %) | (5 | %) | ||||||||||||||||||||||
| Prevnar/Prevenar (7-valent) | - | - | - | - | 81 | 104 | (22 | %) | (12 | %) | - | 34 | (100 | %) | (100 | %) | ||||||||||||||||||||
| Cardura | 22 | 25 | (12 | %) | (12 | %) | 27 | 34 | (21 | %) | (12 | %) | 26 | 24 | 8 | % | 8 | % | ||||||||||||||||||
| EpiPen | - | - | - | - | 10 | 7 | 43 | % | 38 | % | - | - | - | - | ||||||||||||||||||||||
| Revatio | 37 | 32 | 16 | % | 16 | % | 13 | 12 | 8 | % | 17 | % | 8 | 7 | 14 | % | 28 | % | ||||||||||||||||||
| Sulperazon | - | - | - | - | 7 | 9 | (22 | %) | (11 | %) | 64 | 49 | 31 | % | 29 | % | ||||||||||||||||||||
| Xanax XR | 27 | 22 | 23 | % | 18 | % | 9 | 11 | (18 | %) | (9 | %) | 22 | 21 | 5 | % | 5 | % | ||||||||||||||||||
| Inlyta | 10 | - | * | * | 18 | - | * | * | - | - | - | - | ||||||||||||||||||||||||
| Aricept(e) | 14 | 45 | (69 | %) | (69 | %) | 40 | 40 | - | (3 | %) | 8 | 9 | (11 | %) | (11 | %) | |||||||||||||||||||
| Unasyn | 10 | 9 | 11 | % | 11 | % | 18 | 19 | (5 | %) | 5 | % | 27 | 26 | 4 | % | 4 | % | ||||||||||||||||||
| Caduet | 4 | 3 | 33 | % | 33 | % | 35 | 37 | (5 | %) | (3 | %) | 12 | 16 | (25 | %) | (25 | %) | ||||||||||||||||||
| Xalkori | 12 | 3 | * | * | 10 | - | * | * | 3 | - | * | * | ||||||||||||||||||||||||
| Neurontin | 11 | 16 | (31 | %) | (31 | %) | 9 | 10 | (10 | %) | (18 | %) | 22 | 19 | 16 | % | 16 | % | ||||||||||||||||||
| Inspra | 32 | 31 | 3 | % | - | 14 | 13 | 8 | % | 23 | % | 5 | 4 | 25 | % | 25 | % | |||||||||||||||||||
| Toviaz | 20 | 17 | 18 | % | 18 | % | 2 | 2 | - | - | 3 | 2 | 50 | % | 50 | % | ||||||||||||||||||||
| Aromasin | 14 | 20 | (30 | %) | (30 | %) | 9 | 14 | (36 | %) | (29 | %) | 25 | 18 | 39 | % | 39 | % | ||||||||||||||||||
| Dalacin/Cleocin | 7 | 8 | (13 | %) | (13 | %) | 5 | 6 | (17 | %) | - | 21 | 20 | 5 | % | - | ||||||||||||||||||||
| Alliance revenues(f) | 28 | 86 | (67 | %) | (67 | %) | 73 | 152 | (52 | %) | (50 | %) | 11 | 18 | (39 | %) | (39 | %) | ||||||||||||||||||
| All other biopharmaceutical products(g) | 403 | 388 | 4 | % | 2 | % | 289 | 318 | (9 | %) | - | 532 | 507 | 5 | % | 5 | % | |||||||||||||||||||
| All other established products(g) | 281 | 271 | 4 | % | 2 | % | 224 | 245 | (9 | %) | (3 | %) | 448 | 413 | 8 | % | 10 | % | ||||||||||||||||||
| REVENUES FROM OTHER PRODUCTS - INTERNATIONAL: | $ |
361 |
$ | 330 |
9 |
% |
7 |
% | $ | 231 | $ | 238 | (3 | %) | (3 | %) | $ | 511 | $ | 485 | 5 | % | 8 | % | ||||||||||||
|
* Calculation not meaningful. |
||
| (a) |
Developed Europe region includes the following markets: Western Europe, Finland and the Scandinavian countries. |
|
| (b) |
Developed Rest of World region includes the following markets: Australia, Canada, Japan, New Zealand and South Korea. |
|
| (c) |
Emerging Markets region includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, the Middle East, Eastern Europe, Africa, Turkey and Central Europe. |
|
| (d) |
Lipitor lost exclusivity in various international markets in 2011 and 2012. This loss of exclusivity reduced branded international revenues by $581 million in first-quarter 2013, in comparison with first-quarter 2012. |
|
| (e) | Represents direct sales under license agreement with Eisai Co., Ltd. | |
| (f) | Includes Enbrel (in Canada), Spiriva and Aricept. | |
| (g) |
Includes sales of generic atorvastatin. All other established products is a subset of All other biopharmaceutical products. |
|
| Certain amounts and percentages may reflect rounding adjustments. | ||
DISCLOSURE NOTICE: The information contained in this earnings release
and the attachments is as of April 30, 2013. 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 future operating and financial performance,
business plans and prospects, in-line products and product candidates,
strategic reviews, capital allocation, business-development plans, 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,” “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 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, as well as their decisions regarding
labeling, ingredients and other matters that could affect the
availability or commercial potential of our products; -
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; - the success of external business-development activities;
-
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 of an abbreviated legal pathway to
approve biosimilar products, which could subject our biologic products
to competition from biosimilar products in the U.S., 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 the U.S. Budget Control Act of 2011 (the Budget Control
Act) and the deficit-reduction actions to be taken pursuant to the
Budget Control Act in order to achieve the deficit-reduction targets
provided for therein, and the impact of any broader deficit-reduction
efforts; -
the possible failure of the U.S. federal government to suspend
enforcement of the federal debt ceiling beyond May 18, 2013 or to
increase the federal debt ceiling and any resulting inability of the
U.S. federal government to satisfy its financial obligations,
including under Medicare, Medicaid and other publicly funded or
subsidized health programs; -
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 or
repeal of any of the provisions thereof; -
U.S. 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; direct-to-consumer advertising and interactions
with healthcare professionals; and 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; -
legislation or regulatory action in markets outside the U.S. affecting
pharmaceutical product pricing, reimbursement or access, including, in
particular, continued government-mandated price reductions for certain
biopharmaceutical products in certain European and emerging market
countries; -
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 and unstable governments and
legal systems; - 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 of
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; - 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;
-
our ability to successfully implement any strategic alternative that
we decide to pursue with regard to our remaining approximately 80%
ownership interest in Zoetis Inc. and the impact thereof; and -
the impact of acquisitions, divestitures, restructurings, product
recalls and 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.
A further list and description of risks, uncertainties and other matters
can be found in our Annual Report on Form 10-K/A for the fiscal year
ended December 31, 2012 and in our 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 reports on Form 8-K.
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.
This earnings release does not constitute an offer to sell, or a
solicitation of an offer to buy, any securities, which will be made only
by prospectus.
